Dated February__23__,2009 SUPPLY AGREEMENT BETWEEN AND
Exhibit
4.86
Dated February__23__,2009
BETWEEN
(1) Nisshin
Pharma Inc. (“Nisshin”)
AND
(2) Amarin
Pharmaceuticals (Ireland) Ltd. (“Amarin”)
1
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DEFINITIONS
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2
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2
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DUTIES
|
3
|
3
|
ORDER, ACCEPTANCE AND
DELIVERY
|
4
|
4
|
ROLLING FORECAST
|
5
|
5
|
PRICE AND MILESTONE
PAYMENTS
|
6
|
6
|
WORKING GROUP
|
7
|
7
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TECHNICAL AGREEMENT
|
7
|
8
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LONG-TERM SUPPLY AGREEMENT
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7
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9
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TECHNOLOGY TRANSFER
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7
|
10
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WARRANTIES
|
8
|
11
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SHIPPING TERM / TITLE AND
RISK
|
9
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12
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CONFIDENTIAL INFORMATION
|
9
|
13
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FORCE MAJEURE
|
11
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14
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TERM
|
11
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15
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TERMINATION
|
11
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16
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CONSEQUENCES OF TERMINATION
|
12
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17
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ASSIGNMENT
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12
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18
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MISCELLANEOUS
|
12
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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.
THIS AGREEMENT (hereinafter
the "Agreement") is made
as of February 23
, 2009
(hereinafter the "Commencement
Date")
BETWEEN:
Nisshin Pharma, Inc., whose
head office is at 00, Xxxxx-Xxxxxxx-xxx 0-xxxxx, Xxxxxxx-xx, Xxxxx 000-0000
XXXXX ("Nisshin")
AND
Amarin Pharmaceuticals (Ireland)
Ltd., whose head office is at First Floor, Block 3, The Oval, Xxxxxxxxxx
Xxxx, Xxxxxxxxxxx, Xxxxxx 0, Xxxxxxx ("Amarin")(Nisshin and Amarin
each a "Party," collectively, the "Parties")
WITNESSETH:
WHEREAS, Amarin is developing
products for the treatment of certain human diseases (hereinafter referred to as
the “Drug”).
WHEREAS, the Parties entered
into that certain agreement on October 27, 1999 (the "1999 Agreement") for the
supply of ethyl-eicosapentaenoate (“E-EPA”) in bulk style (hereinafter referred
to as “Products”, as further defined below), from Nisshin to Amarin, for the
purposes of conducting clinical trials within the CNS (Central Nervous System)
field, to provide the Products to Amarin to be used as the active pharmaceutical
ingredient for the Drug and for submission to regulatory bodies for approval.
(The 1999 Agreement was originally made and entered into between Nisshin Flour
Milling Co., Ltd., a Japanese corporation, the parent company of Nisshin at that
time, and Laxdale Limited, a Scottish company, now known as Amarin Neuroscience
Limited due to the corporate take-over closed on October 8, 2004 by Amarin
Corporation plc, and the duties and obligations under the 1999 Agreement were
transferred by assignment to the Parties, by Nisshin Flour Milling Co., Ltd. to
Nisshin on July 2, 2001; and by Amarin Neuroscience Limited to Amarin on
November 15, 2005.)
[
*** 3 lines omitted ***]
WHEREAS, upon Amarin’s request
and after discussion with Amarin, Nisshin agreed to extend the 1999 Agreement
for a further three years in 2005, which resulted in the execution of that
certain agreement of November 15, 2005, under which the supply of the Products
was extended until June 6, 2008, as well as Nisshin agreed to cooperate with
Amarin, including but not limited to, for dealing with FDA
inspections.
WHEREAS, upon expiration of
the extended period of supply, further discussions between the Parties occurred,
and, as a result of such discussions, Nisshin is willing to agree to
further cooperate with Amarin by continuing the current supply and providing
assistance related to
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH OMISSIONS.
FDA
inspections for a certain period of time for the use of the Drug, and during
which period Nisshin and Amarin will conduct a joint-analysis of the feasibility
of a long-term supply relationship.
NOW, THEREFORE, THE
PARTIES AGREE as follows:
1
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DEFINITIONS
|
1.1
|
In
this Agreement the following definitions shall apply, unless the context
requires otherwise:
|
"Confidential Information"
includes information related to the Specifications and the Products, as well as
any other information of a technical, operational, administrative, financial or
business nature, know-how, data and any other proprietary information in any
form, that is (a) disclosed (intentionally or unintentionally) by one Party to
the other Party and (b) not publicly known. It does not include
information which is in the public domain, information which was made public
through no breach of this Agreement, information which is independently
developed by a receiving party without access to or use of the proprietary
information of the disclosing party, as evidenced by such party's records, or
information that became available to a receiving party on a non-confidential
basis, whether directly or indirectly, from a source other than the other party
hereto, which source did not acquire this information on a confidential
basis.
[***
12 lines ommitted ***]
"Destination" means the place
designated by Amarin to which the Product shall be transported from
Japan.
"DMF" means Drug Master File,
as defined in (i) the CFR (US Code of Federal Regulations 21, as amended from
time to time) and/or (ii) its equivalent in the EU.
"EMEA" means the European
Medicines Agency or any other successor agency whose approval is necessary to
market the Drug in the EU.
"E-EPA" means ethyl
eicosapentaenoate and is described as “EPA-E” in the submitted DMFs.
“EU” means the Member States of
the European Union, as same may change from time to time in terms of Member
States.
"FDA" means the United States
Food and Drug Administration or any other successor agency whose approval is
necessary to market the Drug in the USA.
"cGMP" means current Good
Manufacturing Practice as defined in (i) the FFDCA (US Federal Food, Drug and
Cosmetic Act of 1934, and the regulations promulgated thereunder, as may be
amended from time to time) and/or (ii) its equivalent rules in EU.
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH OMISSIONS.
2
"Long-Term Supply Agreement"
means an agreement which is under discussion between the Parties for the
supply of the Products after April 1, 2012 based on the discussions of the
Working Group.
"Marketing Approval" means the
final approval to market the Products for the application to human diseases
including Huntington's Disease, Cardiovascular Disease or hypertriglyceridemia
in any country within the Territory.
"Milestone Payments" means
those payments to be made by Amarin to Nisshin as specified in Schedule One.
"Minimum Purchase
Requirements" means the minimum amount of Products that Amarin shall
purchase from Nisshin as specified in Schedule One.
A "person" includes any natural
person, partnership, company, and unincorporated association.
"Prices" means the prices of
Products inclusive of costs and expenses for raw materials, intermediates and
packaging components and includes Mid-Tier Price and Top Tier Price as defined
in Schedule One. The Prices are specified in Schedule One.
"Products" means those
products listed in Schedule
Two by agreement between the Parties in writing.
"Specifications" means each of
the specifications for the Products provided by Nisshin to Amarin and annexed in
Schedule Three, as
amended from time to time by agreement between the Parties in
writing.
"Technical Agreement" means an
agreement to be executed between the Parties pursuant to Clause 7 which governs,
inter alia, the responsibilities of each party as regards quality matters
relating to the Products.
"Territory" means all the
countries of the world except Japan.
"US” or “USA” means the United
States of America.
2
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DUTIES
|
2.1
|
During
the term of this Agreement, Nisshin shall manufacture at its manufacturing
plant, and supply to Amarin its requirements of the Products pursuant to
the terms and conditions of this
Agreement.
|
2.2
|
Nisshin
shall not knowingly export, sell or distribute the Products to any company
who sell or distribute E-EPA in the
Territory.
|
2.3
|
This
Agreement does not impose any restriction of any nature on Amarin
obtaining a supply of E-EPA from suppliers other than Nisshin or from
itself manufacturing E-EPA.
|
2.4
|
Nisshin
shall ensure that the Products meet the
Specifications.
|
3
2.5
|
Amarin
shall purchase the Minimum Purchase Requirements of the Products from
Nisshin as specified in Schedule
One.
|
2.6
|
Amarin
shall make sure that all payments for these purchases are made without
delay.
|
2.7
|
Nisshin
shall provide reasonable assistance to Amarin for the purpose of Amarin's
import clearances in respect of the
Products.
|
2.8
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Regulatory
|
2.8.1
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Save
as otherwise agreed in writing with Amarin, Nisshin shall maintain the US
DMF and the EU DMF currently in
place.
|
Nisshin
may, at its own discretion, authorise Amarin to reference Nisshin’s DMF, as
described herein, with any relevant government health authority to the extent
that Nisshin agrees such reference is necessary to enable Amarin to file
regulatory applications and to maintain any Marketing Approval or other
regulatory approval.
2.8.2
|
Each
party shall promptly notify the other party of any notification received
from a regulatory agency, such as a relevant government health authority,
to conduct an inspection of the manufacturing site(s) or other facilities
used by Nisshin in the development, manufacturing, packaging, storage or
handling of the Product. Copies of all applicable
correspondence with the regulatory agency will be provided to the other
party.
|
2.8.3
|
Nisshin
shall make that portion of its facility where the Products are
manufactured, tested or stored, including related record and reference
samples, available for:
|
(i) inspection
by a relevant governmental agency; or
(ii) audit
by Amarin's employees, agents or contractors upon Nisshin’s prior consent to
such audit.
Nisshin
shall fully co-operate with any inspection hereunder and provide necessary
information and documents as may reasonably be required.
2.8.4
|
Following
full consultation with Amarin, Nisshin will be responsible for responding
to any notifications or inspections concerning the supply of the Product
by the FDA or EMEA.
|
3
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ORDER,
ACCEPTANCE AND DELIVERY
|
3.1
|
Amarin
may, at any time, but no later than ninety (90) days before the specified
date of shipment of the Products, issue to Nisshin individual purchase
orders ("Order") for the Products to be delivered to
Amarin. Each Order, upon acceptance by Nishhin, shall
constitute a definitive individual contract for the sale and delivery of
Products. Nisshin shall issue an acceptance or rejection of the Order
within two (2) weeks from Nisshin’s receipt of the
Order.
|
4
3.2
|
Nisshin
and Amarin shall perform its respective obligations under the individual
contracts.
|
3.3
|
Amarin
shall inspect the Products within fifteen (15) days of receipt of the
Product and may reject any Products that fail to meet the Specifications,
have defects or are damaged in any way. Any Product not
rejected within fifteen (15) days shall be deemed to have been accepted by
Amarin ("Acceptance"). For the avoidance of doubt, Nisshin
shall also be responsible for latent defects in the Products which become
apparent after Acceptance, provided that such defect shall be notified to
Nisshin in writing without delay and not later than three (3) months from
the receipt of the Products by
Amarin.
|
3.4
|
Notwithstanding
the provisions of the above Clause, Amarin may, at its own discretion,
have a third party conduct the inspection of the Product. Under such
circumstances, Amarin will have thirty (30) days from receipt of the
Product to reject any Products that fail to meet the Specifications, have
defects or are damaged in any way.
|
3.5
|
Claims
for latent defects, not discovered during the aforementioned inspections
protocols in Clauses 3.3 and 3.4, shall be made in writing within 3 days
of discovery. Failure to make a timely claim in the aforementioned manner
shall constitute and shall be deemed to be Acceptance of the delivery by
Amarin and a waiver of right to claim by
Amarin.
|
4
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ROLLING
FORECAST
|
4.1
|
Prior
to the first Marketing Approval, but not later than thirty (30) days
following the Commencement Date, Amarin shall provide Nisshin with a
twelve (12) month demand forecast. Thereafter, until Amarin’s submission
of a regulatory filing for Marketing Approval, Amarin shall provide
Nishhin with twelve (12) month demand forecasts on an annual
basis.
|
4.2
|
Within
two hundred and ten (210) days following Amarin's submission of a
regulatory filing for Marketing Approval in the US or EU, Amarin shall
provide Nisshin with a binding order for its launch stocks
requirements. Thereafter, Amarin shall, on a monthly basis,
provide Nisshin with a written rolling forecast for the following 12-month
period.
|
4.3
|
The
forecast amount for the first three months of the rolling forecast
stipulated in the Clause immediately above shall constitute binding
orders. The forecast amounts for the remaining nine months of
such rolling forecast, i.e., months 4-12, shall be non-fixed forecast
amounts. Amarin has the right to vary the forecast amounts for
months 4, 5 and 6 by +/-25%. Amarin may vary the forecast
amounts for months 7-12 without limitation. Nisshin shall not be obligated
to supply Products in excess of the binding forecast amounts contained in
the rolling forecasts.
|
5
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PRICE
AND MILESTONE PAYMENTS
|
5.1
|
The
Price and Milestone Payments shall be as set forth in Schedule
One.
|
5.2
|
Nisshin
shall issue the invoice for the Product supplied in each shipment to
Amarin within 10 days from the date of each shipment. Amarin
shall pay the invoice amount for the Products delivered to it in
accordance with this Agreement into an account designated by Nisshin
within 30 days from the date of the corresponding invoice
issued
|
5
by
Nisshin.
5.3
|
In
the event Amarin fails to pay the Price of any of its purchases by the due
date provided in Clause 5.2 above, Nisshin is entitled, at its own
discretion, to suspend dispatching the Products or to withhold from
accepting Amarin’s Order until Amarin makes full payment with interest
from the due date to the date of payment calculated using an annual
interest rate of 6% per annum.
|
5.4
|
Amarin
shall reimburse Nisshin's reasonable costs for preparing and maintaining
the DMF prior to Amarin's receipt of each relevant Marketing Approval in
both US and EU.
|
5.5
|
Amarin
will reimburse to Nisshin all reasonable costs specifically related to
preparing for an inspection of any facility by a regulatory authority and
audit of any facility by any consultant with regard to cGMP, including but
not limited to interpreter’s fees for the inspection and
audit.
|
6
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WORKING
GROUP
|
6.1
|
The
Parties shall form a joint working group (the "Working Group") to address
issues related to their future relationship for long term supply after
April 2012, including: (a) Long-Term Supply Agreement; (b) pricing; (c)
supply chain structure; (d) capacity expansion; (e) investment
requirements; (f) third party agreements (g) technology transfer; and (h)
the possible formation of a new business entity to supply Product to
Amarin. As more fully described in Clause 8, the Working Group
will make all reasonable efforts to review and discuss feasibility of such
long term supply relationship between the Parties by addressing the issues
outlined above by June 30, 2010 whether or not it is feasible for the
Parties to agree a long-term plan for supplying the
Product.
|
6.2
|
The
Working Group shall consist of the appropriate representatives from each
party having requisite authority to speak on behalf of each respective
company, provided, however, that the Working Group is not responsible nor
is it entrusted to establish business policy or to make decisions on
behalf of either Party. The number of representatives can be expanded with
the mutual agreement of both Parties. Each Party bears its own costs in
acting as part of the Working
Group.
|
6.3
|
The
Working Group shall meet in person as soon as practicable after the
Commencement Date and on a regular basis thereafter. The
Working Group shall hold discussions via meetings, teleconferences and
e-mail as appropriate and necessary to discuss in good faith the issues
set forth in Clause 6.1 of this Agreement. In the first
meeting, the Working Group will set the specific agenda and timing/venue
for the second meeting. The second meeting will set the specific agenda
and timing/venue for the third meeting, and so forth, provided, however,
that any meeting can be re-scheduled flexibly taking into account either
Party’s situation.
|
6.4
|
The
Working Group shall have no power or authority to enter into any binding
agreements on behalf of either
Party.
|
7
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TECHNICAL
AGREEMENT
|
7.1
|
After
the Commencement Date, the Parties will initiate the negotiation for the
Technical Agreement, which is necessary for any review by any regulatory
authority in advance of
|
6
approval
of the Drug for marketing, to identify their respective responsibilities in
accordance with accepted GMP during the term of this Agreement.
8
|
LONG-TERM
SUPPLY AGREEMENT
|
8.1
|
Pursuant
to Clause 6.1, the Parties shall conclude discussions no later than June
30, 2010 with regard to the Long-Term Supply Agreement for the supply of
the Products by Nisshin to Amarin. If the Parties agree to the
future supply scheme, the Parties will in good faith negotiate for the
terms of the Long-Term Supply Agreement. The Long-Term Supply
Agreement will determine how the Products are supplied after April 1,
2012.
|
9
|
TECHNOLOGY
TRANSFER
|
9.1
|
If
this Agreement has not been terminated by Nisshin
in accordance with Clause 15.1 of this Agreement (where Amarin has
committed a material breach of the terms of this Agreement and has failed
to remedy such breach within 60 days of receiving the relevant written
notice from Nisshin pursuant to Clause 15.1), or in accordance with
Clause 15.2 of this Agreement, in the event that the Long-Term Supply
Agreement is not executed by the Parties on or before December 31, 2010,
Nisshin will transfer the technology necessary and performed at Nisshin’s
current site to manufacture the Products upon the request of Amarin, to
Amarin or an entity established or designated by Amarin (which will
include transferring the DMF).
|
9.2
|
Nisshin
shall also be obliged to transfer the technology stipulated in Clause 9.1
upon the request of Amarin, to Amarin or to an entity established or
designated by Amarin if Amarin gives Nisshin notice of termination of the
Agreement under Clause 15.1 or 15.2, or if Nisshin gives Amarin notice of
termination of the Agreement under Clause 15.4.
|
9.3
|
Amarin
will be responsible for any and all costs associated with the
aforementioned transfer of technology. The other terms and
conditions of the transfer of technology will be discussed
separately. When the transfer of technology process is being
conducted, except for where the transfer of technology is triggered by
Nisshin giving Amarin notice of termination of the Agreement under Clause
15.4, Nisshin will work with Amarin to use best efforts to try to ensure
that there is no interruption in the supply of the Products to Amarin. If
the transfer of technology would not be completed during the term of this
Agreement, the Parties will consult each other in
good faith on
how to deal with the case,
including an
extension of this Agreement for a period of time which
the
Parties consider necessary to complete the transfer of
technology.
|
9.4
|
Amarin
agrees and confirms that the technology transfer provided in this Clause 9
will be Nisshin’s sole obligation in case the Long-Term Supply Agreement
is not executed on or before December 31,
2010.
|
10
|
WARRANTIES
|
10.1
|
Nisshin
hereby warrants that any Products manufactured pursuant to this Agreement
shall comply with the Specifications and all requirements of
cGMP.
|
10.2
|
Amarin
and Nisshin hereby represent and warrant to each other, as of the date of
this Agreement, as follows:
|
10.2.1
|
Each
Party has the right to enter into this
Agreement.
|
7
10.2.2
|
There
are no agreements between either Amarin or Nisshin and any third party
that conflict with this Agreement in the
Territory.
|
10.3
|
Nisshin
does not make and hereby disclaims any warranty with respect to the
Products other than the warranty set forth in Clauses 10.1 and 10.2,
whether expressed or implied.
|
10.4
|
Each
Party shall promptly notify the other Party of any breach of warranties
set forth in Clauses 10.1 to 10. 2.
|
10.5
|
If
any Products are not manufactured in accordance with the Specifications,
Nisshin at its sole option shall:
|
10.5.1
|
at
Nisshin’s cost, supply replacement of the Products conforming with Clause
10.1; or
|
10.5.2
|
refund
the Price or any part of the Price corresponding to the Products that does
not meet Specifications.
|
11
|
SHIPPING
TERM / TITLE AND RISK
|
11.1
|
Nisshin
shall ship the Products FOB Tokyo, as defined in Incoterms
2000.
|
11.2
|
Title
to the Products shall pass from Nisshin to Amarin upon the delivery of the
Products to the Destination in accordance with the
Order.
|
11.3
|
Nisshin
will be responsible for organizing the transport by air and insurance
arrangements for the delivery of the Products from the site of manufacture
to the Destination. Amarin will reimburse Nisshin for the costs of the
transport and insurance arrangements for the said delivery of the Products
from the site of manufacture to the
Destination.
|
12
|
CONFIDENTIAL
INFORMATION
|
12.1
|
The
Parties shall keep Confidential Information strictly confidential, shall
not disclose it to any third party other than Bizen Chemical Ltd., and
Nisshin Seifun Group Inc., the current parent company of Nisshin. Save as
otherwise specifically provided herein, the Parties shall only disclose
Confidential Information to those of its employees, representatives and
agents requiring knowledge thereof in connection with fulfilling that
Party's obligations under this
Agreement.
|
12.2
|
The
Parties further agree to inform all such employees, representatives and
agents of confidential nature of the Confidential Information and their
duties hereunder and make reasonable measures to make employees,
representatives and agent comply with the duties
hereunder.
|
The
Parties shall exercise the same standard of care as they would 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
party.
12.3
|
Notwithstanding
the provisions of this Clause 12, if one of the Parties
(“Disclosing
|
8
Party”)
or any person who received the Confidential Information in accordance with
Clause 12.1 is requested or required by any court of competent jurisdiction, any
competent judicial, governmental or regulatory body, pursuant to any relevant
law or regulation to disclose any of the Confidential Information, the
Disclosing Party will make reasonable effort to provide the other Party with a
notice so as to afford the other Party the opportunity, at the other Party's
expense, to pursue a protective order or other remedy and the Disclosing Party
shall reasonably cooperate with the other Party in such efforts to the extent
practical and permitted under applicable laws and regulations. In no
event shall the Disclosing Party be liable for any damages resulting from
disclosure of the Confidential Information pursuant to this
Clause. Disclosure of Confidential Information by a Disclosing
Party in accordance with this Clause shall not be a breach of this
Agreement.
12.4
|
The
Parties shall use the Confidential Information exclusively for performance
of this Agreement and for no other
purpose.
|
12.5
|
Upon
termination or expiration of this Agreement, each Party shall promptly,
upon request of the other Party, return all documents and any copies
thereof containing Confidential Information belonging to, or disclosed by,
such other Party.
|
12.6
|
The
Parties agree that the obligations of this Clause 12 are necessary and
reasonable in order to protect the Parties' respective
businesses.
|
12.7
|
The
Parties agree that any such violation or threatened violation may cause
irreparable injury to a Party and that, in addition to any other remedies
that may be available, 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 such relief to redress such breach together with
damages and reasonable counsel fees and expenses to enforce its rights
hereunder.
|
12.8
|
Subject
to Clause 12.3, no announcement or public statement concerning the
existence, subject matter or any term of this Agreement shall be made by
or on behalf of any Party without the prior written approval of the other
Party.
|
The terms
of any such announcement shall be agreed in good faith by the
Parties.
12.9
|
Amarin
shall obtain Nisshin’s prior written consent if Amarin needs to disclose
this Agreement to a potential third party purchaser or commercialisation
partner or current or future Amarin investor (collectively “Potential
Partner”), provided that the relevant third party has entered into a
confidentiality agreement on terms no less protective than the terms of
this Clause 12. When Amarin wishes to obtain such Nisshin’s consent,
Amarin will provide advance written notification to Nisshin of identity of
such third party with the relevant information of the third party. Nisshin
will make response to the notification as soon as practicable.
If Nisshin decides not to agree to provide its consent, Nisshin
will provide Amarin with a written reason why such consent was
withheld.
Notwithstanding the foregoing, Nisshin will not withhold, condition or
delay its consent hereunder if the Potential Partner’s primary line of
business is in the area of pharmaceuticals or
biotechnology.
|
9
12.10
|
Amarin
shall indemnify Nisshin against any claims, costs (including legal costs,
expenses), liabilities, losses (including loss of profit), damages or
expenses arising out of, or in connection with the disclosure of this
Agreement pursuant to Clause 12.9.
|
13
|
FORCE
MAJEURE
|
13.1
|
If
either Party is prevented or delayed in the performance of any of its
obligations under this Agreement as a result of acts of God, war, fire,
earthquake, or other natural disaster beyond the reasonable control of a
Party that has not occurred as a result of its act, omission or negligence
and which was not reasonably foreseeable ("Force Majeure Event"), it shall
notify the other Party, in writing, of the same as soon as
practicable. The affected Party shall use its reasonable
endeavours to remove or overcome such Force Majeure Event as quickly as
possible and shall also use its reasonable endeavours to mitigate the
impact of such Force Majeure Event of the other Party. Subject
to Clause 13.3, if a Party shall have fully complied with its obligations
under this Clause 13.1, it shall be excused from performance of its
unfulfilled obligations under this Agreement from the date of such notice
until such Force Majeure Event no longer
pertains.
|
13.2
|
A
Force Majeure Event will include any issue either Party has with its
subcontractors or suppliers of raw materials, intermediates and packaging
components, which were caused by one of the Force Majeure Events described
in Clause 13.1.
|
13.3
|
If
a Force Majeure Event prevents the performance by a Party of any
obligations hereunder for a continuous period in excess of 12 weeks, the
other Party shall be entitled to terminate this Agreement by written
notice at any time after such 12 week period provided the relevant Force
Majeure Event is continuing at the time such notice is
given.
|
14
|
TERM
|
14.1
|
This
Agreement shall be effective from the Commencement Date until March 31,
2012.
|
15
|
TERMINATION
|
15.1
|
This
Agreement may be terminated by either Party by giving to the other Party a
notice in writing if the other Party commits a material breach of the
terms of this Agreement and (where such breach is capable of remedy) fails
to remedy such breach within 60 days of receiving a written notice from
the terminating Party specifying the breach and requiring its
remedy.
|
15.2
|
This
Agreement may be terminated by either Party immediately by giving a
written notice to the other, if:
|
15.2.1
|
a
petition is filed by or against the other Party for commencement of
bankruptcy proceeding (hasan-tetsuzuki-kaishi), commencement of corporate
reorganization proceeding (kaishakousei-tetsuzuki-kaishi), commencement of
civil rehabilitation proceeding
(minjisaisei-tetsuzuki-kaishi), or any other insolvency
proceeding;
|
15.2.2
|
the
other Party is subject to seizure (sashiosae), sequestration
(xxxx-sashiosae), preservative attachment (hozen-sashiosae), commencement
of public auction (keibai),
or other compulsory execution (kyousei-shikkou) or foreclosure
(tanpoken-jikkou) proceeding against material assets of the other
Party;
|
10
15.2.3
|
the
other Party is unable to pay its debts in the normal course of business;
or
|
15.2.4
|
there
is a Change of Control of the other
Party.
|
15.3
|
Notwithstanding
the provisions of Clause 15.1, this Agreement may be terminated by Nisshin
by giving Amarin 30 days notice in writing, if Amarin fails to perform its
duty as set forth in Clause 2.5, unless, within such 30 days, Amarin pays
to Nisshin the amount corresponding to the unfulfilled purchases according
to the minimum purchase quantities at the Price stated in Schedule
One.
|
15.4
|
This
Agreement may be terminated by Nisshin by giving Amarin notice in writing
without Nisshin incurring any liability or obligation whatsoever (except
the obligations under Clause 9), if Nisshin is unable to continue
manufacturing and supplying the Products to Amarin in accordance with its
requirement due to disruption of supplies of raw materials or
intermediates, which disruption cannot be recovered within reasonable
time, provided that Nisshin shall without delay inform Amarin of
occurrence of such event in order to give Amarin an opportunity to seek
alternative sources.
|
16
|
CONSEQUENCES
OF TERMINATION
|
16.1
|
In
the event that this Agreement is terminated, neither Party shall be
entitled to compensation of damages for lost profits arising out of the
termination of this Agreement.
|
16.2
|
Notwithstanding
any provisions herein to the contrary, in the event that this Agreement is
terminated for any reason, Amarin shall purchase and take delivery of all
the Products manufactured by Nisshin according to Orders placed by Amarin
at the Price stipulated herein, and shall purchase, at cost, all stocks of
the Products either manufactured or in the process of being manufactured
for Amarin, including unused intermediates that Nisshin
stores.
|
The
provisions of Clauses 6, 9, 12, 16 and 18 shall survive the expiration or
termination of this Agreement up to three years after the expiration or
termination of this Agreement.
17
|
ASSIGNMENT
|
Neither
Party may assign this Agreement or any of its rights or obligations under this
Agreement without the prior written consent of the other Party which consent
shall not be unreasonably withheld or delayed provided, however,
that:
17.1.
|
either
Party may assign this Agreement, in whole or in part, to an affiliate of
the assigning Party; provided, that the assigning Party guarantees the
performance of such affiliate hereunder;
and
|
17.2
|
Amarin
may assign this Agreement, in whole, to the Potential Partner disclosed
under
this Agreement pursuant to Clause 12.9 who acquires, by merger,
sale of assets or otherwise, all or substantially all of the business of
the assigning Party in which the subject matter of this Agreement is
included.
|
18
|
MISCELLANEOUS
|
18.1
|
All
notices, consents, approvals or other communications hereunder shall be in
writing
|
11
and shall
be delivered personally or by registered or certified mail, postage prepaid, or
sent by fax, addressed to the authorised personnel at relevant Party and at such
address as each Party shall from time to time notify the other in writing. Any
such notice, consent, approval and other communication shall be deemed given, in
the case of personal delivery, on the date of delivery, in the case of mailing,
on the fifth (5th) day following its deposit in the mail and in the case of a
fax, on the next business day after the day of transmission provided the
sender’s facsimile machine produces a report showing complete and successful
transmission to the correct facsimile number.
18.2
|
Nothing
in this Agreement shall constitute or be deemed to constitute the creation
of a partnership, agency, or employer/employee relationship between the
parties.
|
18.3
|
This
Agreement, together with the Specifications and the Schedules attached
hereto, constitutes the entire agreement and understanding of the parties
and supersedes any previous agreement between Nisshin and Amarin in
relation to the subject matter of this Agreement. This Agreement,
the Specification, and the Schedules attached hereto or any order may only
be modified only by a written document signed on behalf of each of the
parties. If there are any inconsistencies between the terms and
conditions of this Agreement and the terms and conditions set forth in any
quotation, order, acknowledgement or invoice, the terms and conditions of
this Agreement shall prevail.
|
18.4
|
If
any provision of this Agreement is held by any court or other competent
authority to be invalid or unenforceable in whole or in part, it shall be
deemed severed from this Agreement and the validity of the other
provisions and the remainder of the provision in question shall not be
affected.
|
18.5
|
This
Agreement shall be governed by and construed in accordance with the laws
of Japan.
|
18.6
|
The
parties hereto shall submit to the exclusive jurisdiction of the Tokyo
District Court of Japan with respect to any dispute arising from this
Agreement.
|
IN
WITNESS HEREOF, each of the Parties has caused this Agreement to be executed by
its duly authorized representative on and as of the date first written
above.
12
NISSHIN
PHARMA, INC.
|
By:
____________________________________ Date: ,
2009
|
Name:
Xxxxxxxxx Xxxxxxxxx
|
Title: President
|
AMARIN
PHARMACEUTICALS IRELAND LTD.
|
By:
____________________________________ Date: ,
2009
|
Name:
Xxxx Xxxxx
|
Title: Director
|
13
SCHEDULE
ONE
PRICES
/ MINIMUM PURCHASE REQUIREMENTS / MILESTONE PAYMENTS
PRICES
The Price
for the first five (5) metric tons of the Product purchased from Nisshin by
Amarin in each Fiscal Year (as defined below) is JPY [***********].
The Price
(the "Mid-Tier Price") for any amount of Product purchased from Nisshin by
Amarin after the first five (5) metric tons, but not in excess of twelve (12)
metric tons of Product in each Fiscal Year (as defined below) is as
follows:
[***********] for the
part after the first five (5) metric tons,
|
||
but
not excess eight (8) metric tons, and
|
||
[***********] for the
part after the eight (8) metric tons,
|
||
but
not excess twelve (12) metric
tons.
|
If
Nisshin presents evidence that its manufacturing cost for the Products has
increased, because of significant changes in matters beyond its reasonable
control, such as the price of crude fish oil, and that such change has been
independently recognized by an industry-recognized credible source, then Amarin
and Nisshin will discuss the revision of the aforementioned prices for the
Product in good faith. If the aforementioned discussion cannot be successfully
completed remotely, then the Parties will be obligated to meet in person to
discuss the aforementioned matter in good faith.
[***
10 lines omitted ***]
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH OMISSIONS.
14
MINIUMUM
PURCHASE REQUIREMENTS
Amarin
shall purchase the following minimum amounts of the Product from each April to
March fiscal year ("Fiscal Year") beginning in the calendar year first indicated
in each item a-d below.
a)
|
2008-2009
|
1.62
metric tons
|
|
b)
|
2009-2010
|
1.08
metric tons
|
|
c)
|
2010-2011
|
3.24
metric tons
|
|
d)
|
2011-2012
|
3.24
metric tons
|
MILESTONE
PAYMENTS
Amarin
shall make the following non-refundable one-time payments to Nisshin upon
satisfaction of the conditions set forth below:
a) USD500,000
upon the signing of this Agreement by both Parties; and
b) USD500,000
upon the first Marketing Approval of the Product in the US or the
EU.
For the
avoidance of doubt, the Parties acknowledge that Amarin shall be required to pay
each of the Milestone Payments only one time and provided that the related
condition has been satisfied. Further, the Parties also acknowledge
that the Milestone Payments are not refundable by Nisshin even in case the
Parties’ discussion does not result in execution of the Long-Term
Agreement.
15
SCHEDULE
TWO
THE
PRODUCTS
Products
Products
means the E-EPA pharmaceutical drug substance which meets the Specification
defined in the Schedule Three and manufactured by Nisshin and
E-EPA
means:
the
compound which chemical name is
Ethyl
(5Z,8Z,11Z,14Z,17Z)-5,8,11,14,17-icosapentaenoate
Company
Code Name which is described in the US-DMF and EDMF is
EPA-E
Common
name is
Ethyl
eicosapentaenoate
and
Chemical
Abstracts Registry (CAS) Number is
00000-00-0
16
SCHEDULE
THREE
[***
Approximately 34 lines omitted ***]
CONFIDENTIAL
INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS [*] DENOTE SUCH OMISSIONS.
17
SCHEDULE
FOUR
AMARIN’s
CURRENT INVESTORS
Shareholder
|
Shares
|
Basic %
|
Sofinnova Venture Partners VII, LP
|
3,586,957
|
13.26%
|
Orbimed Advisors LLC
|
3,260,870
|
12.06%
|
Xxxxxx, XxXxxxxx & Partners
LLC
|
2,173,913
|
8.04%
|
Panorama Capital LP
|
1,847,826
|
6.83%
|
Sunninghill Limited
|
1,465,755
|
5.42%
|
Xxxxx Xxxxx
|
1,277,695
|
4.72%
|
Longitude Venture Partners,
LP
|
1,086,957
|
4.02%
|
Amarin Investment Holding
Limited
|
1,072,906
|
3.97%
|
Fountain Healthcare Partners
Fund
|
217,391
|
0.80%
|
Xxxxxxx Xxxxx
|
74,828
|
0.28%
|
Total
|
16,065,098
|
59.40%
|
18