Dated 18 January 2007 and and and AGREEMENT for termination and release of certain confidentiality obligations Reed Smith Rambaud Charot LLP Minerva House London SE1 9BB United Kingdom Tel: +44 20 7403 2900 Fax: +44 20 7403 4221 Ref: JNW/GP
Exhibit 4.62
Dated
18 January 2007
______________________________________
(1)
NEUROSTAT PHARMACEUTICALS INC.
and
(2)
AMARIN PHARMACEUTICALS IRELAND LIMITED
and
(3)
AMARIN CORPORATION PLC
and
(4)
XXX XXXXX
________________________________________
for
termination and release of
certain
confidentiality obligations
________________________________________
Xxxx
Xxxxx Xxxxxxx Charot LLP
Xxxxxxx
Xxxxx
0
Xxxxxxxx Xxxxx
Xxxxxx
XX0 0XX
Xxxxxx
Xxxxxxx
Tel: x00
00 0000 0000
Fax: x00
00 0000 0000
xxx.xxxxxxxxx.xxx
Ref: JNW/GP
THIS
AGREEMENT IS MADE ON 18 JANUARY 2007
PARTIES
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(1)
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NEUROSTAT PHARMACEUTICALS
INC. a company organised under the laws of the state of Delaware,
with a principal place of business at 0000 XX Xxxxx Xxxxxx, Xxxx, XX
00000, Xxxxxx Xxxxxx of America (NeuroStat);
and
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(2)
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AMARIN PHARMACEUTICALS IRELAND
LIMITED a company incorporated in Ireland under registration number
408912, with a registered office is at 00 Xxxxxxxx Xxxx, Xxxxxxxxxxx,
Xxxxxx 0, Xxxxxxxx of Ireland (Amarin Pharma);
and
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(3)
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AMARIN CORPORATION PLC a
company registered in England with registered number 02353920 and a
registered office at 000 Xxxxxx Xxxxxx, Xxxxxx XX0X 0XX, Xxxxxx Xxxxxxx
(Amarin Corp);
and
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(4)
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XXX XXXXX of 0000 XX
Xxxxx Xxxxxx, Xxxx, XX 00000, Xxxxxx Xxxxxx of America (Xx
Xxxxx).
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BACKGROUND
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(A)
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Amarin
Pharma is a neuroscience company focused on the research, development and
commercialisation of novel drugs for the treatment of central nervous
system disorders. Amarin Pharma is a wholly-owned subsidiary of
Amarin Corp.
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(B)
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NeuroStat
and Amarin Corp entered into an Mutual Confidentiality Agreement dated 2
November 2006 (the Confidentiality
Agreement). NeuroStat has valuable, confidential
information relating to various forms of Lorazepam (as defined below)
including a compound known as nano-Lorazepam under development by Elan
Corporation plc of Xxxxxxxx Xxxxxxxx, Xxxxx Xxxxx Xxxxx Xxxxxx, Xxxxxx 0,
Xxxxxxxx of Ireland and its Affiliates (as defined below) (together
referred to as Elan; and specifically
including Elan Pharma International Limited, a limited liability company
incorporated under the laws of
Ireland).
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(C)
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Under
the Confidentiality Agreement, due to the sensitivity of the Confidential
Information held by NeuroStat, Amarin Corp agreed, among other things, not
to pursue the license or development of a Lorazepam product with Elan or
any of its affiliates. NeuroStat and Amarin Corp have agreed to
terminate the Confidentiality Agreement on the following terms and
conditions.
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NOW, THEREFORE, in
consideration of the mutual promises and covenants contained in this Agreement
and for other good and valuable consideration, the sufficiency of which is
hereby acknowledged, the Parties hereto agree as follows:
1. Definitions and
Interpretation
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1.1
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Affiliate means, with respect
to a particular Party, a person, corporation, partnership or other entity, that
from to time Controls, is Controlled by, or is under common Control with such a
Party;
Agreement means this agreement
and any and all schedules, appendices and other addenda to it as may be varied
from time to time in accordance with the provisions of this
agreement;
Business Day means a day other
than a Saturday, Sunday, bank or other public holiday in England, the Republic
of Ireland or the state of Oregon;
Commencement Date means the
date set out at the beginning of Agreement;
Confidential Information means
any proprietary information which is not in the public domain, whether or not
such information is identified as confidential, including, without limitation,
information relating to products, processes, services, businesses, personnel,
research, commercial activities, formulas, materials, compounds, substances,
programmes, devices, concepts, inventions, patents, designs, methods,
techniques, intellectual property, marketing and commercial strategies, data,
trade secrets, know-how, plans, operations, tests, studies, manuals, market
reports, customers, contracts, financial status, cash flow projections and the
like or any other matter connected with the business of a Party or any of its,
suppliers, partners or customers related to a Party or its
business;
Control means:
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(a)
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with
respect to any legal entity, the direct or indirect ownership or
possession of (i) the power to direct or cause the direction of the
management and policies of a company or entity whether by contract or
otherwise; (ii) at least 50% (in the aggregate) of the voting power of all
outstanding shares entitled to vote at a general election of directors of
a company or entity; or (iii) at least 50% of the assets of a company or
entity;
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(b)
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with
respect to any material, item of information, or intellectual property
right, the possession, whether by ownership or licence, of the right to
grant a licence or sub-licence with respect thereto, without breaching any
prior written obligation to any Third
Party,
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and Controlled shall be construed
accordingly;
Elan Lorazepam Agreement has
the meaning given such term in Clause 4.1(b)(i).
Licensed Know How means all
the Confidential Information Controlled by NeuroStat at or at any time after the
Commencement Date relating to Products and/or their development and/or
commercialisation, which, for the avoidance of doubt shall not include any
Confidential Information of Elan;
Lorazepam means the active
drug substance Lorazepam the chemical structure and formula for which are set
forth in Exhibit A, together with and including all salts, esters, complexes,
chelates, isomers (including stereoisomers), crystalline forms, amorphous forms,
prodrugs (including all compounds that are metabolized or dissolve into the same
active moiety in the body), solvates (including hydrates), metabolites/metabolic
precursors, and pegylated forms thereof.
Parties means Xx Xxxxx,
NeuroStat, Amarin Corp and Amarin Pharma, and Party shall mean either of
them;
Product means any product in
any formulation containing any form of Lorazepam, including any nasally
administered nanocrystal formulation of Lorazepam; any injectible (including via
intravenous, intramuscular and or-subcutaneous injection), buccal, sublingual,
rectal or inhalation nanocrystal formulation of Lorazepam; and/or any other
nanocrystal formulation of Lorazepam;
Third Party means any entity
or person other than the Parties and their Affiliates.
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1.2
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In
this Agreement:
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(a)
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unless
the context otherwise requires, all references to a particular clause or
schedule shall be a reference to that clause or schedule in or to this
Agreement as it may be amended from time to time pursuant to this
Agreement;
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(b)
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the
headings are inserted for convenience only and shall be ignored in
construing this Agreement;
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(c)
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unless
the contrary intention appears, words importing the masculine gender shall
include the feminine and vice versa and words in the singular include the
plural and vice versa;
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(d)
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any
reference to persons includes natural persons, firms, partnerships,
limited liability partnerships, companies, corporations, unincorporated
associations, local authorities, governments, states, foundations and
trusts (in each case whether or not having separate legal personality) and
any agency of any of the above;
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(e)
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any
phrase introduced by the terms “including”, “include”, “in particular” or
any similar expression shall be construed as illustrative and shall not
limit the sense of the words preceding those
terms;
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(f)
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any
reference to a statute, statutory provision or subordinate legislation
(legislation) (except where the context otherwise requires) (i) shall be
deemed to include any bye-laws, licences, statutory instruments, rules,
regulations, orders, notices, directions, consents or permissions made
under that legislation and (ii) shall be construed as referring to any
legislation which replaces, re-enacts, amends or consolidates such
legislation (with or without modification) at any time;
and
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(g)
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any
reference to a Party includes a reference to their respective
successors-in-title and permitted
assignees.
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2. Release and
Termination
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2.1
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Subject
to the terms and conditions of this Agreement, NeuroStat and Amarin Corp
hereby agree to terminate the Confidentiality Agreement and release each
other from further compliance with the Confidentiality Agreement with
effect from the Commencement Date.
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2.2
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Subject
to Amarin Corp’s satisfaction of its obligations under this Agreement,
NeuroStat hereby releases, waives and discharges Amarin Corp and its
Affiliates, successors, directors, agents, servants, officers,
shareholders, employees and representatives of and from all claims, debts,
demands, rights and causes of action, arising out of the transactions,
events and occurrences, or any other claims NeuroStat presently may have
against Amarin Corp, relating to the Confidentiality
Agreement.
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2.3
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Amarin
Corp hereby releases, waives and forever discharges NeuroStat and its
Affiliates, successors, directors, agents, servants, officers,
shareholders, employees and representatives of and from all claims, debts,
demands, rights and causes of action, arising out of the transactions,
events and occurrences, or any other claims Amarin Corp presently may have
against NeuroStat, relating to the Confidentiality
Agreement.
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3. Technical
Assistance
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3.1
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NeuroStat
shall, forthwith following the Commencement Date and free of charge to
Amarin Pharma, disclose and supply to Amarin Pharma any and all Licensed
Know How to the extent not already disclosed to Amarin Corp or Amarin
Pharma. To avoid any doubt, NeuroStat has no obligation to
disclose any information with respect to which it or Xxx Xxxxx has any
obligation of confidentiality or non-use to
Elan.
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3.2
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Xx
Xxxxx shall enter into a consultancy agreement on mutually acceptable
terms pursuant to which, during a period of six months following the
Commencement Date, Xx Xxxxx
shall render such assistance as Amarin Pharma may request in negotiations
with Elan relating to the in-licensing of rights to Products and in
initiating development of Products. Xx Xxxxx shall be
remunerated on a daily rate basis and the rate payable shall be
US$2,000. NeuroStat hereby irrevocably consents to such an
arrangement.
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4. Consideration
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4.1
|
In
consideration of the terms and conditions of this Agreement, including the
license of the Licensed Know How pursuant to Clause 6 and the release and
termination pursuant to Clause 2, and conditional upon Amarin Pharma or an
Affiliate of Amarin Pharma entering into an Elan Lorazepam Agreement (as
defined below):
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(a)
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In
exchange for the property rights set forth above, Amarin Corp shall issue
to NeuroStat, within 10 days of Amarin Pharma or an Affiliate of Amarin
Pharma entering into an Elan Lorazepam Agreement, immediately exercisable
warrants to purchase 175,000 ordinary shares of Amarin Corp of five xxxxx
par value at the exercise price per share set forth below in the form of
ADSs, exercisable no later than the seventh anniversary of the
Commencement Date on 10 days’ written notice to Amarin Corp (the Warrants). The
Warrants and the underlying ADSs shall be issued to NeuroStat pursuant to
a prospectus supplement to Amarin Corp’s shelf registration statement
filed with the Securities Exchange Commission which became effective on 2
August 2006.
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NeuroStat
may exercise the Warrants in respect of amounts of not less than 25,000
ordinary shares on each occasion of
exercise.
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The
exercise price of the Warrants shall be the NASDAQ closing price on the
Business Day before the date upon which Amarin Pharma or an Affiliate of
Amarin Pharma enters into Elan Lorazepam
Agreement.
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(b)
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Amarin
Pharma shall make the following payments to
NeuroStat:
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(i)
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a
non-refundable, non-creditable sum of US$165,000 within 10 days after the
date upon which Amarin Pharma or any Affiliate of Amarin Pharma executes a
legally-binding agreement with Elan (or any one of the companies that is
defined as being part of Elan) pursuant to which Amarin Pharma or any
Affiliate of Amarin Pharma obtains any right with respect to or in
connection with any Product, including any license, any option, any
covenant not to xxx, any supply commitment, any right to distribute,
and/or any other right with respect to or in connection with any Product
(each, an Elan Lorazepam
Agreement; Elan Lorazepam Agreements exclude, however,
any confidential disclosure or similar agreement in both cases pursuant to
which Amarin Pharma or any Affiliate of Amarin Pharma obtains solely the
right to use confidential information relating to Lorazepam or Products in
order to evaluate whether to enter into an Elan Lorazepam Agreement but
does not receive any other rights with
respect
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to or in
connection with any Product (including the kinds enumerated
above); to avoid any doubt the mere presence of confidentiality
provisions within a license agreement or other agreement granting Product rights
(confidentiality provisions would, by way of background, ordinarily be expected
to be included in any such agreement) shall not qualify the agreement as the
kind of confidentiality agreement that is excluded from the Elan Lorazepam
Agreements); and
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(ii)
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non-refundable,
non-creditable milestone payments within 10 days after the relevant
milestone event as follows:
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(A)
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US$200,000
on the first administration to a human subject of a Product covered by an
Elan Lorazepam Agreement (defined in Clause 4.1(b)(i));
and
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(B)
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US$200,000
on the first administration to a human subject of a Product covered by an
Elan Lorazepam Agreement (defined in Clause 4.1(b)(i)) in the first
clinical study that is designed to assess the efficacy of such a Product,
however such clinical trial is denominated (with respect to phase of
trial) and whether or not such first clinical study is in a limited
patient group. Clinical studies in any patient population (or
patient populations) are considered “designed to assess the efficacy of
such a Product” for this purpose.
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(the
payments of (A) and (B) in this Clause 4.1(b)(ii) are together referred to as
the Milestone Payments)
provided that Amarin Corp may elect to discharge fully Amarin Pharma’s
obligation to make the Milestones Payments by issuing to NeuroStat ordinary
shares of five xxxxx par value in the capital of Amarin Corp to the value of the
Milestone Payment at the NASDAQ closing price on the day before the relevant
milestone event occurs. Such shares will be represented by ADSs
issued to NeuroStat pursuant to a prospectus supplement to Amarin Corp’s shelf
registration statement filed with the Securities Exchange Commission which
became effective on 2 August 2006.
It is
acknowledged for the avoidance of doubt that (A) and (B) each apply when the
events described therein occur, and whether they are achieved by or on behalf of
any of Amarin Pharma, an Amarin Affiliate, a sublicensee of Amarin Pharma or an
Amarin Affiliate, or another entity contracted with or engaged by any of
them.
Amarin
Pharma shall notify NeuroStat and Xx. Xxxxx in writing within three (3) days
after the occurrence of each of the events referred to in this Clause 4.1
(including the signing of an Elan Lorazepam Agreement and each of Milestone
events (A) and (B)).
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4.2
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Within
five days from the Commencement Date or, if later, receipt by Amarin
Pharma of the relevant copy invoices, Amarin Pharma shall reimburse
NeuroStat’s and Xx Xxxxx’x reasonable and documented attorneys’ fees and
expenses in connection with the negotiation and documentation of this
Agreement and to the extent such fees and expenses do not exceed in total
US$15,000.
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5. Non-Compete
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5.1
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NeuroStat
and Xx Xxxxx hereby jointly undertake that neither shall, and each of
NeuroStat and Xx Xxxxx shall procure that none of NeuroStat’s Affiliates
shall, whether alone or in conjunction with an Affiliate or Third
Party:
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(a)
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Prior
to the expiration or termination of this Agreement, enter into or continue
any discussions or negotiations relating to the grant by Elan of any
rights in any Product to NeuroStat, any Affiliate of NeuroStat or Xx Xxxxx
or any entity Controlled by Xx Xxxxx;
or
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(b)
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Prior
to the expiration or termination of this Agreement, research, develop,
use, keep, make, have made, import, offer for sale, sell or otherwise
dispose of Products anywhere in the world or grant or receive any licence
to do any of the foregoing.
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The
Parties acknowledge that the foregoing restriction is reasonable, valid and
necessary for the protection of Amarin’s business with respect to Products to
which it may obtain rights pursuant to an Elan Lorazepam Agreement and that
Amarin Pharma would not have entered into this Agreement without the foregoing
protection.
Furthermore
each of the undertakings contained in each of Clauses 5.1(a) and (b) shall be,
and is, a separate undertaking by each of NeuroStat and Xx Xxxxx and shall be
enforceable by Amarin Pharma separately and independently of the right of the
Amarin Pharma to enforce any one or more of the other covenants contained in
Clause 5 and in the event that any of such undertakings shall be found to be
void but would be valid if some part thereof were deleted then such undertaking
shall apply with such deletion as may be necessary to make it valid and
effective.
6. Grant of Licence
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6.1
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Subject
to the terms and conditions of this Agreement, NeuroStat hereby grants to
Amarin Pharma and its Affiliates an exclusive, worldwide right and license
to use the Licensed Know-How to (a) seek to enter into an Elan Lorazepam
Agreement, and (b) to research, develop, use, make, have made, import,
offer for sale, sell and otherwise dispose of Products with respect to
which Amarin Pharma or an Amarin Pharma Affiliate has obtained rights
pursuant to an Elan Lorazepam Agreement. Such license to Amarin
Pharma and its Affiliates shall include the right to grant sub-licenses
within the scope of
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activities
described in clause (b) of the foregoing sentence (including the right to grant
sub-licensees the right to grant further sub-licensable sub-licences); provided
that the activities of the sub-licensees (including all further sub-licensees,
direct and indirect) shall be deemed to be activities of Amarin Pharma for
purposes of the payment obligations under this Agreement. Such
license to Amarin Pharma and its Affiliates shall be royalty-bearing in the
sense that payments to NeuroStat are required under this Agreement, partially in
consideration of such license; but other than the payments explicitly called for
under this Agreement, such license to Amarin Pharma and its Affiliates shall be
royalty-free.
7. Payment Terms
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7.1
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All
payments due to NeuroStat under this Agreement shall be made in US dollars
and by electronic bank transfer to an account specified by
NeuroStat.
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7.2
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Without
prejudice to NeuroStat’s right to receive payment on the due date, where
NeuroStat does not receive payment of any sums due to it pursuant to this
Clause 4 within the time specified, interest shall accrue on the sum due
and owing to NeuroStat at the rate equivalent to an annual rate the
greater of (i) 1% over the then current base rate of National Westminster
Bank plc, for the United Kingdom, calculated on a daily basis, and (ii)
10% and such interest shall run from the date on which payment is due to
the date on which payment is made by Amarin Pharma, which the Parties
acknowledge to be a substantial remedy for failure to pay the sums due
within the time specified. If Amarin is late in tendering any
payment that it is otherwise permitted to tender in warrants or equity
(e.g., if it does not tender payment in warrants or equity within the
10-day period for payment after achievement of the event triggering
payment under Clause 4.1), then NeuroStat shall be entitled by written
notice to Amarin to require the payment to be made by wire transfer of
immediately available funds instead; provided that if Amarin
timely notified NeuroStat in writing of the payment-triggering event for
the particular payment as required under Clause 4.1 by a notice that is in
accordance with Clause 14, then Amarin will have 3 business days from
receiving NeuroStat's written notice that payment is due to make the
payment of warrants, equity or
cash.
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7.3
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All
payments to NeuroStat under this Agreement are expressed to be exclusive
of goods, sales, valued added or any similar such tax (Value Added Tax)
howsoever arising, and Amarin Corp or Amarin Pharma (as the case may be)
shall pay to NeuroStat in addition to those payments or if earlier on
receipt of a tax invoice or invoices from NeuroStat, all Value Added Tax
for which NeuroStat is liable to account to any competent authority in
relation to any supply made or deemed to be made for Value Added Tax
purposes pursuant to this
Agreement.
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7.4
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NeuroStat
shall be entitled to request to audit and shall be given access to
appropriate records to confirm the timing payments are due hereunder (and
in the case of payments made in warrants or equity the appropriate
calculation of the number of warrants or shares in accordance with this
Agreement).
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8. Warranties and
Liability
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8.1
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Each
Party represents and warrants to the other Parties
that:
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(a)
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it
has legal power, authority and right to enter into this Agreement and to
perform its respective obligations
hereunder;
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(b)
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it
is not at the Commencement Date a party to any agreement, arrangement or
understanding with any Third Party which conflicts with this
Agreement;
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(c)
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this
Agreement has been duly authorised, executed, and delivered by that Party
and is a valid, binding, and legally enforceable obligation of that Party;
and
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(d)
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no
consent, approval, authorisation, or order of any court or governmental
agency or body is required for the consummation of the transactions
contemplated by this Agreement.
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8.2
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NeuroStat
gives no warranty of any nature as to the completeness, accuracy or
otherwise of the Licensed Know How and accepts no liability howsoever
arising from Amarin Pharma’s use of the Licensed Know
How.
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8.3
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Subject
to Clause 8.4, neither Party shall be liable to the other or any of the
other Party’s Affiliates or any sub-licensees for any of the following
types of loss, damage, cost or expense arising (whether in contract, tort,
negligence, breach of statutory duty or otherwise) under or in relation to
this Agreement or the subject-matter of this
Agreement:
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(a)
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any
loss of profits, business, contracts, anticipated savings, goodwill, or
revenue; or
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(b)
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any
indirect or consequential loss or damage whatsoever, even if that party
was advised in advance of the possibility of such loss or damage;
or
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(c)
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any
punitive, exemplary or similar
damages.
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8.4
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Nothing
in Clause 8.2 shall prohibit or hinder the exercise of another Party’s
rights in respect of any liability for fraud or fraudulent
misrepresentation, notwithstanding that any loss or damage that Party may
be seeking to recover is of the type referred to in Clause
8.2.
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8.5
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The
rights, powers and remedies provided in this Agreement are (except as
expressly provided) cumulative and not exclusive of any rights, powers and
remedies provided by law, or
otherwise.
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9. Confidentiality
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9.1
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A
confidential relationship with respect to such Confidential Information
shall be established as of the Commencement Date between the
Parties.
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9.2
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Each
Party to whom Confidential Information is disclosed (a Recipient) by another
Party (a Disclosing
Party) shall use all necessary care to prevent disclosure or
release of Confidential Information of a Disclosing Party to any third
party, except with the Disclosing Party’s prior written
consent. Each Recipient shall limit dissemination of
Confidential Information of a Disclosing Party to those officers and
employees of Recipient who reasonably require access to Confidential
Information of a Disclosing Party for the purposes of this
Agreement and who have been made aware that Confidential Information is
confidential, are bound by written obligations of confidentiality to the
Recipient to treat information such as the Confidential Information of a
Disclosing Party in the strictest
confidence.
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9.3
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Each
Recipient shall only use the Confidential Information of a Disclosing
Party for the purposes of this Agreement including in the case
of Amarin Pharma as permitted by Clause
6.
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9.4
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Recipient
undertakes to maintain in confidence the fact that discussions are or will
be taking place, the nature of the discussions envisaged by this Agreement
and the fact that the parties have entered into this
Agreement.
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9.5
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All
Confidential Information given or transmitted under the terms of this
Agreement will be subject to the terms of this Agreement, except for
Confidential Information that a Recipient can
establish:
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(a)
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came
lawfully into Recipient’s possession prior to the date of
disclosure;
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(b)
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is
or becomes public knowledge through no fault or omission of
Recipient;
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(c)
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is
required to be disclosed by law, in which case Recipient shall give the
Disclosing Party as much advance notice of the proposed disclosure as is
practical (including a copy of any written request or order), and shall
cooperate with the Disclosing Party in any effort to limit or restrict
such disclosure, via a protective order or
otherwise;
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(d)
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is
furnished or made known to the Recipient by a third party otherwise than
in breach of any obligation of confidentiality to the Disclosing Party;
or
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(e)
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is
independently developed by the Recipient or one of its Affiliates, without
access to the Confidential Information disclosed by the Disclosing
Party.
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9.6
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The
terms of this Agreement and negotiations leading to the execution of this
Agreement shall be considered to be Confidential Information of both
parties.
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9.7
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The
obligations of confidence referred to in this Clause 9 shall furthermore
not extend to any Confidential Information
which:
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(a)
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being
Licensed Know How, Amarin Pharma considers reasonably considers should be
disclosed to sub-licensees, agents, consultants, Affiliates and/or other
Third Parties for the research and development, manufacturing and/or
marketing of Products (or for such Third Parties to determine their
interest in performing such activities) on the condition that such Third
Parties agree to be bound by confidentiality obligations no less onerous
than those contained in this Agreement;
and
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(b)
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Amarin
Pharma reasonably wishes to disclose to consultants, agents or other Third
Parties solely to the extent required in connection with the purposes of
this Agreement or in connection with due diligence or similar
investigations by such Third Parties, and disclosure to potential Third
Party investors in confidential financing documents or for the purposes of
such financing (and, for the avoidance of doubt to potential sub-licensees
or other strategic partners) on the condition that such Third Parties
agree to be bound by confidentiality obligations no less onerous than
those contained in this Agreement.
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9.8
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It
is acknowledged for the avoidance of doubt that Confidential Information
disclosed pursuant to the Confidentiality Agreement shall be considered to
have been disclosed pursuant to, and subject to the provision of, this
Agreement.
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9.9
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The
Parties recognise and agree that remedies at law for breach of the
provisions of this Clause 9 are likely to be inadequate and that the
disclosing Party shall, in addition to any other rights it may have, be
entitled to seek injunctive relief.
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9.10
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The
obligations of each Party under this Clause 9 shall survive until five
years after the expiry or termination for whatever reason of this
Agreement.
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10. Term and
Termination
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10.1
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This
Agreement shall come into effect on the Commencement Date and, subject to
earlier termination in accordance with this Clause 10, will expire on the
first anniversary of the Commencement Date provided that in the event that
Amarin Pharma or an Affiliate of Amarin Pharma enters into an agreement
with Elan for the development of Products prior to the first anniversary
of the Commencement Date and prior to earlier termination under this
Clause 10, Amarin Pharma shall on written notice be entitled to extend the
term of this Agreement until the second anniversary of the date on which
such agreement with Elan enters
effect.
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10.2
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Each
of NeuroStat and Amarin Pharma shall have the right to terminate this
Agreement effective at any time on or after 1 June 2007 on 30 days’
written notice to Amarin Pharma and NeuroStat
respectively. This right to terminate can only take effect
if
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Amarin
Pharma or an Affiliate has not entered into an Elan Lorazepam Agreement at the
date of termination.
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10.3
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Amarin
Pharma on the one hand or NeuroStat on the other hand (the Terminating Party) shall
have the right to terminate this Agreement in its entirety forthwith upon
giving written notice of termination to NeuroStat and Xx Xxxxx on the one
hand or Amarin Corp and Amarin Pharma on the other hand (the Defaulting Party), upon
the occurrence of any of the following events at any time during this
Agreement:
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|
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(a)
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the
Defaulting Party commits a material breach of an obligation set out in
this Agreement which is not capable of remedy;
or
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(b)
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the
Defaulting Party commits a material breach of an obligation set out in
this Agreement which is capable of remedy but has not been remedied within
30 days of the receipt by it of a notice identifying the breach and
requiring its remedy.
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11. Consequences of
Termination
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11.1
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In
the event of expiry of this Agreement or termination of this Agreement
pursuant to Clause 10.2 and 10.3: (a) subject to Clause 11.2, all rights
and licences granted to Amarin under this Agreement shall terminate; and
(b) each Party shall return all data, files, records and other materials
in its possession or control containing or comprising the other Party’s
Confidential Information to which such first Party does not retain rights
hereunder (except one copy of which may be retained by the returning
Party’s legal department solely for archival
purposes).
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11.2
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Following
the expiry of this Agreement after the extended term set out in the
proviso to Clause 10.1 (but not otherwise), the exclusive license granted
pursuant to Clause 6.1 shall -- subject to Amarin and its Affiliates'
continued compliance with this Agreement, including payment obligations,
and in particular (but without limitation) the next sentence -- become
irrevocable, perpetual, fully paid-up and royalty-free (subject to the
next sentence), but shall otherwise continue in full force and
effect. Notwithstanding the foregoing, if all
consideration provided to be payable or potentially payable under Clause 4
have not as of the time of such expiration been paid, then the obligations
to provide the remaining-unpaid consideration shall survive and in this
sense the license shall remain royalty-bearing until all such
consideration has been paid.
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11.3
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Following
the expiry or termination of this Agreement, Amarin Corp, Amarin Pharma
and the Affiliates of each of them shall not pursue the license or
development of a Lorazepam Product with Elan (or any of the companies
defined as being part of Elan), and shall not enter into any Elan
Lorazepam Agreement, unless Amarin Pharma or an Affiliate has previously
entered into an Elan Lorazepam Agreement prior to the expiry or
termination of this Agreement. Without limiting or implying any
exception to the foregoing, if Amarin Pharma, Amarin Corp, or the
Affiliate of either of them enters into any Elan Lorazepam Agreement or
develops a Lorazepam Product with or under license with (or other right
from) Elan (or any of the companies defined as being part of
Elan)
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following
the expiration or termination of this Agreement, then the Parties agree that the
damages to NeuroStat and Xx. Xxxxx shall be no less than the total consideration
provided for in Clause 4, calculated as if all contingencies have been achieved
(whether or not actually achieved), payable by wire transfer of immediately
available funds (and specifically not payable in equity). Amarin Corp
shall pay such amount to NeuroStat within three (3) Business Days after
receiving written notice from NeuroStat that NeuroStat requires such payment to
be made. The Parties hereby explicitly instruct any judge, jury,
arbitrator or other arbiter of any dispute relating to a breach of this Clause
11.3 to award NeuroStat at least such amount, plus any additional damages that
may be available at law or in equity in relation to such a breach, but excluding
punitive, exemplary and similar damages. This Clause 11.3 shall
survive any expiration or termination of this Agreement.
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11.4
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Termination
or expiry of this Agreement for whatever reason shall not affect the
accrued rights of the Parties arising in any way out of this Agreement as
at the date of termination or expiry and in particular but without
limitation the right to recover damages and interest, and the provisions
of Clauses 9, 10 and 11 shall remain in full force and
effect. NeuroStat’s and Xx. Xxxxx’x rights under Clause 4 shall
be considered accrued rights as of the Effective Date for this purpose,
however, the payments under Clause 4 shall not actually be due until the
times provided for in Clause 4 (i.e., each payment remains contingent on
achievement of the corresponding Milestone or other event specified in
Clause 4, but such contingency need not be achieved prior to the
expiration or termination of this
Agreement).
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12.
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Waiver
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12.1
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No
Party shall be deemed to have waived any of its rights or remedies
conferred by this Agreement unless the waiver is made in writing and
signed by a duly authorised representative of that Party. In
particular, no delay or failure of any Party in exercising or enforcing
any of its rights or remedies conferred by this Agreement shall operate as
a waiver of those rights or remedies or so as to preclude or impair the
exercise or enforcement of those rights or remedies nor shall any partial
exercise or enforcement of any right or remedy by any Party preclude or
impair any other exercise or enforcement of that right or remedy by that
Party.
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13. Entire
Agreement/Variations
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13.1
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This
Agreement constitutes the entire agreement and understanding between the
Parties and supersedes all prior oral or written understandings,
arrangements, representations or agreements between them relating to the
subject matter of this Agreement (including the Confidentiality
Agreement).
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13.2
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No
variation, amendments, modification or supplement to this Agreement shall
be valid unless made in writing in the English language and signed by a
duly authorised representative of each
Party.
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14. Notices
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14.1
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Any
notice to be given pursuant to this Agreement shall be in writing in the
English language and shall be delivered by hand, sent by registered or
recorded delivery airmail post or sent by facsimile confirmed by
registered or recorded delivery post to the address or facsimile number of
the recipient set out at the start of this Agreement or such other address
or facsimile number as a Party may from time to time designate by written
notice to the other Party.
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14.2
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Any
notice given pursuant to this Clause 14 shall be deemed to have been
received:
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(a)
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in
the case of delivery by hand, when delivered;
or
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(b)
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in
the case of sending by post:
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(i)
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where
posted in the country of the addressee, on the third Business Day
following the day of posting; and
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(ii)
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where
posted in any other country, on the seventh Business Day following the day
of posting; or
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(c)
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in
the case of facsimile, on acknowledgement by the recipient facsimile
receiving equipment on a Business Day if the acknowledgement occurs before
1700 hours local time of the recipient and in any other case on the
following Business Day.
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14.3
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All
notices to NeuroStat and all notices to Xx. Xxxxx must also be faxed to x0
000 000 0000, attention Xxxxx Xxxxxxxxxx, and x0 000 000 0000, attention
Chip Lion to be considered effectively given under this
agreement. For the avoidance of doubt, the absence of Xx.
Xxxxxxxxxx or Mr. Lion from these fax numbers, law firm or locations will
not adversely affect whether or not the required copy notice has been
given.
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15. Assignment
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15.1
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Neither
Party may assign its rights or delegate its obligations under this
Agreement, whether by operation of law or otherwise, in whole or in part
without the prior written consent of the other Party, which consent shall
not be unreasonably withheld or delayed, except that Amarin Corp and
Amarin Pharma shall always have the right, without such consent: (a) to
perform any or all of their obligations and exercise any or all of their
rights under this Agreement through any of their Affiliates or
sub-licensees; and (b) assign any or all of their rights and delegate any
or all of its obligations hereunder to any of their Affiliates or to any
successor in interest (whether by merger, acquisition, asset purchase or
otherwise) to all or substantially all of the business to which this
Agreement relates (which shall include any sub-licensee under any rights
granted to Amarin Pharma or an Affiliate pursuant to an agreement with
Elan for the development of
Products),
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provided
that Amarin Corp or Amarin Pharma (as the case may be) shall provide written
notice to NeuroStat within 30 days after such assignment or
delegation.
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15.2
|
Any
permitted successor of a Party or any permitted assignee of all of a
Party’s rights under this Agreement that has also assumed all of such
Party’s obligations hereunder in writing shall, upon any such succession
or assignment and assumption, be deemed to be a party to this Agreement as
though named herein in substitution for the assigning Party, whereupon the
assigning Party shall cease to be a party to this Agreement and shall
cease to have any rights or obligations under this
Agreement.
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15.3
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All
validly assigned rights of a Party shall inure to the benefit of and be
enforceable by, and all validly delegated obligations of such Party shall
be binding on and be enforceable against, the permitted successors and
assigns of such Party. Any attempted assignment or delegation
in violation of this Clause 15 shall be
void.
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16. Force Majeure
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16.1
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No
Party shall be liable to another Party for failure or delay of any of its
obligations under this Agreement, for the time and to the extent such
failure or delay is caused by riots, civil commotions, wars, hostilities
between nations, embargoes, acts of God, storms, fires, accidents, labour
disputes or strikes, sabotage, explosions or other similar or different
contingencies which affect its performance or are beyond its reasonable
control. If the performance of any obligation under this Agreement is
delayed owing to force majeure for any continuous period of more than six
months, the Parties shall consult with respect to an equitable solution,
including the possible termination of this
Agreement.
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17. Severance of
Terms
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17.1
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If
the whole or any part of this Agreement is or becomes or is declared
illegal, invalid or unenforceable in any jurisdiction for any reason
(including both by reason of the provisions of any legislation and also by
reason of any court or competent authority which either has jurisdiction
over this Agreement or has jurisdiction over any of the
Parties):
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(a)
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in
the case of the illegality, invalidity or un-enforceability of the whole
of this Agreement it shall terminate only in relation to the jurisdiction
in question; or
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(b)
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in
the case of the illegality, invalidity or un-enforceability of part of
this Agreement that part shall be severed from this Agreement in the
jurisdiction in question and that illegality, invalidity or
un-enforceability shall not in any way whatsoever prejudice or affect the
remaining parts of this Agreement which shall continue in full force and
effect.
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17.2
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If
in the reasonable opinion of any Party any severance under this Clause 17
materially affects the commercial basis of this Agreement, the Parties
shall discuss, in good faith, ways to eliminate the material
effect.
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18. This Agreement not to Constitute a
Partnership
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18.1
|
None
of the provisions of this Agreement shall be deemed to constitute a
partnership between the Parties and neither Party shall have any authority
to bind the other in any way except as provided in this
Agreement.
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19. Public Statements
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19.1
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Except
as provided in Clause 19.2, neither Party shall, without the prior written
consent of the other Party:
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(a)
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release
any information about this Agreement, or any information or results of
work undertaken by either Party pursuant to this Agreement;
or
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(b)
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use
in advertising, publicly or otherwise, any trade-name, personal name,
trade xxxx, trade device, service xxxx, symbol, or any abbreviation,
contraction or simulation thereof, owned by the other Party;
or
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(c)
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represent,
either directly or indirectly, that any product or service of the other
Party is a product or service of the representing Party or that it is made
in accordance with or utilises the information or documents of the other
Party.
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19.2
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The
restrictions in Clause 19.1 shall not apply to the
following:
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(a)
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use
as required by any applicable law or governmental regulation;
or
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(b)
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any
disclosures as a Party determines, based on the advice of counsel, are
required to comply with law or applicable rule or regulation of any
nationally recognised securities exchange (such exchange to include the
London Stock Exchange, Euronext and NASDAQ), provided the same is
accurate.
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20. Costs and
Execution
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20.1
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Save
as provided in Clause 4.2, each Party shall bear its own legal costs,
legal fees and other expenses incurred in the preparation and execution of
this Agreement.
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20.2
|
This
Agreement may be entered into by the parties in any number of
counterparts. Each counterpart shall, when executed and
delivered, be regarded as an original, and all the counterparts shall
together constitute one and the same instrument. This Agreement
shall not take effect until it has been executed by all the
parties. This Agreement may be validly exchanged and delivered
by fax.
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21. Third Party
Rights
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21.1
|
It
is hereby agreed that this Agreement is not intended by the Parties to
create rights or benefits in favour of any person not party to this
Agreement or make any rights or benefits enforceable by or on behalf of
such third parties and for the avoidance of doubt all laws providing to
the contrary in any country including the provisions of the Contracts
(Rights of Third Parties) Xxx 0000 in the United Kingdom are hereby
excluded to the fullest extent
permitted.
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22. Governing Law and
Jurisdiction
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22.1
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This
Agreement shall be governed by the laws of the State of New York,
USA.
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22.2
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23.
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Attorneys’
Fees
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23.1
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In
the event that any suit or action is instituted to enforce any of the
terms of this Agreement, the prevailing party in such dispute shall be
entitled to all fees, costs and expenses of enforcing any right of such
prevailing party under or with respect to this Agreement (including
reasonable attorneys’ fees), in addition to any other relief to which such
party is entitled.
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[REMAINDER
OF PAGE INTENTIONALLY BLANK]
This
Agreement shall come into force on the date given at the beginning of this
Agreement.
Signed
by /s/
Xxxxxxx X. Xxxxx
Full name
(capitals): XXXXXXX X. XXXXX
Position:CEO
FOR
AND ON BEHALF OF NEUROSTAT PHARMACEUTICALS INC.
Signed
by /s/
Xxxxxxx X. Xxxxx
XXX
XXXXX
Signed
by /s/
Xxxx Xxxxx
Full name
(capitals): XXXX XXXXX
Position:
CFO, DIRECTOR
FOR
AND ON BEHALF OF AMARIN CORPORATION PLC
Signed
by /s/
Xxxx Xxxxx
Full name
(capitals): XXXX XXXXX
Position: CFO,
DIRECTOR
FOR
AND ON BEHALF OF AMARIN PHARMACEUTICALS IRELAND LIMITED
EXHIBIT
A
LORAZEPAM
COMPOUND STRUCTURE AND FORMULA
(including
certain synonyms)
• Structure and primary
formula:
• Systematic IUPAC
Name:
9-chloro-6-(2-chlorophenyl)-4-hydroxy-2,5-diazabicyclo[5.4.0]undeca-5,8,10,12-tetraen-3-one
• Other formulae and chemical names for
this compound (excludes brand names):
0X-0,0-Xxxxxxxxxxxxx-0-xxx,
0-xxxxxx-0-(0-xxxxxxxxxxxx)-0,0-xxxxxxx-0-xxxxxxx-
0X-0,0-Xxxxxxxxxxxxx-0-xxx,
7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-
7-Chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
7-Chloro-5-(2-chlorophenyl)-3-hydroxy-1H-1,4-benzodiazepin-2(3H)-one
2H,1,4-Benzodiazepin-2-one,
7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-
2H-1,
4-Benzodiazepin-2-one, 0-xxxxxx-0- (x-xxxxxxxxxxxx)-0,
0-xxxxxxx-0-xxxxxxx-
0X-0,0-Xxxxxxxxxxxxx-0-xxx,
7-chloro-5- (2-chlorophenyl)-1,3-dihydro-3-hydroxy-
7-Chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one
