EX-4.65
7
u51347exv4w65.htm
EXHIBIT 4.65
Exhibit 4.65
Execution
version
DATED 17 MAY 2006
(1) AMARIN PHARMACEUTICALS IRELAND LIMITED
AND
(2) DR XXXXXXX XXXXXX
ASSIGNMENT AGREEMENT
XXXXXXXX XXXXXX XXXXXXXX
00 Xxxxxxx Xxxxxx
Xxxxxx 0
Xxxxxxx
CONTENTS
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1
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Definitions
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3
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2
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Assignment
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6
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3
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Developer Know-How/Developer
Improvements
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Development Work
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5
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Payments
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6
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Developer Licence Agreements
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Warranties
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Indemnification
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Patent Prosecution and Maintenance
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Regulatory Matters
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Simbec Study Agreement
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12
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Confidential
Information/Announcements
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13
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Payments, Reports and Audits
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Change of Control
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Miscellaneous
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Schedule 1 — Developer
Patents
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2
THIS
ASSIGNMENT AGREEMENT
(this
“Agreement”) dated 17 May 2006
BETWEEN:
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| (1)
| AMARIN PHARMACEUTICALS IRELAND LIMITED, a company
incorporated under the laws of Ireland having its principal
place of business at 00 Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx 4
(“Amarin”); and
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| |
| (2)
| DR XXXXXXX XXXXXX of Scots Xxxxx Xxxxx, Xxxxxx Xxxx,
Xxxxxxxxxx, Xxxxxxxxxxx XX0 0XX (“Developer”).
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RECITALS
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| A. |
The parties have entered into an Option Agreement dated
23 February 2006 and a Development and Option Agreement
dated 21 April 2006 whereby, inter alia, Developer granted
Amarin an exclusive option to conclude this Agreement.
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| B. |
Developer and Amarin have agreed that Developer will assign and
transfer to Amarin the Developer Intellectual Property.
|
NOW, IT
IS HEREBY AGREED AS
FOLLOWS
in consideration of the mutual covenants contained herein:
1 DEFINITIONS
“Affiliate” shall mean a corporation or entity
controlling, controlled by, or under the common control with
Amarin or Developer, as the case may be. For the purposes of
this Agreement, “control” shall mean the direct or
indirect ownership of more than 50% of the issued voting shares
or other voting rights of the subject entity to elect directors,
or if not meeting the preceding criteria, any entity owned or
controlled by or owning or controlling at the maximum control or
ownership right permitted in the country where such entity
exists.
“Amarin Milestone Payments” shall mean the
milestone payments payable by Amarin to the Developer in
accordance with Clause 5.3.
“Change of Control of Amarin” shall mean with
respect to either Amarin or Amarin Corporation plc (a) a
sale, transfer or disposal of all or substantially all of such
company’s assets or business to a third party which is not
a direct or indirect subsidiary of Amarin Corporation plc or
(b) a change in voting control of 50% or more of the
outstanding voting securities of such company to a third party
which is not a direct or indirect subsidiary of Amarin
Corporation plc.
“Claims” shall mean all and any claims (whether
successful or otherwise), loss, liability, damages and expenses,
including reasonable attorneys’ fees and expenses and legal
costs.
“Compound” shall mean apomorphine
and/or all
derivatives of apomorphine.
“Confidential Information” shall mean know-how,
trade secrets, inventions (including patent applications
covering such inventions), data, information, and any
improvements, modifications, derivations, or compilations
thereto that is owned, licensed by or controlled by the
disclosing party, provided however, that Confidential
Information shall not include any information which is:
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| | (i)
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already known to the receiving party at the time of disclosure,
as evidenced by such party’s written records, provided such
information was not obtained directly or indirectly by the
receiving party from the disclosing party pursuant to a
confidentiality agreement;
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| | (ii)
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publicly known prior to or after disclosure, through no default
of the receiving party;
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| | (iii)
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disclosed in good faith to the receiving party by a third party,
lawfully and contractually entitled to make such
disclosure; or
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| | (iv)
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is independently discovered without the aid or application of
the Confidential Information as shall be evidenced by the
written records of the receiving party.
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“Consideration” shall mean the Initial
Consideration, the Amarin Milestone Payments and the Royalties.
3
“Consideration Period” shall mean the period
commencing on the Effective Date and expiring on a product by
product and country by country basis:
| | |
| | (i)
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on the 20th anniversary of the date of the launch of the
Developer Invention in the country concerned; or
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| | (ii)
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in any country upon the expiry of the life of the last to expire
patent included in the Developer Intellectual Property which
covers the Developer Invention in that country;
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whichever date is the later to occur.
“Developer” shall mean Dr Xxxxxxx Xxxxxx and
any of his Affiliates.
“Delivery Kit” shall mean a two compartment
device where one compartment contains an acidic solution of the
Compound and the second compartment contains an alkaline
solution, as described in the Developer Patents.
“Developer Intellectual Property” shall mean
the Developer Patents, Developer Know-How, Developer Patent
Improvements and Developer Improvements.
“Developer Improvements” shall mean any and all
improvements to the Developer Know-How
and/or
Developer Invention
and/or the
Compound
and/or any
Other Apomorphine Product that have been conceived, created,
developed
and/or
otherwise invented solely by, or by a third party on behalf of,
the Developer at any time after the Effective Date.
“Developer Invention” shall mean an invention
relating to a pharmaceutical formulation of the Compound for
buccal administration comprising a Delivery Kit, the Compound
and a buffered solvent, as more fully described in the
Developer’s Patents.
“Developer Know-How” shall mean any and all
rights owned, licensed or controlled by the Developer to any
scientific, pharmaceutical or technical information, data,
discovery, invention (whether patentable or not), know-how,
substances, techniques, processes, systems, formulations,
designs and expertise relating to the Developer Invention
and/or the
Compound
and/or any
Other Apomorphine Product which is not generally known to the
public.
“Developer Patents” shall mean any and all
rights under any and all patent applications
and/or
patents, now existing, currently pending or hereafter filed or
obtained or licensed by Developer relating to the Developer
Invention
and/or the
Compound
and/or any
Other Apomorphine Product, including but not limited to those
set forth in Schedule 1, and any foreign counterparts
thereof and ail divisionals, continuations,
continuations-in-part,
any foreign counterparts thereof and all patents issuing on any
of the foregoing, and any foreign counterparts thereof, together
with all registrations, reissues, re-examinations, supplemental
protection certificates, or extensions thereof, and any foreign
counterparts thereof.
“Developer Patent Improvements” shall mean any
and all improvements to the Developer Patents that have been
conceived, created, developed
and/or
otherwise invented solely by, or by a third party on behalf of,
the Developer at any time after the Effective Date.
“Effective Date” shall mean the date of this
Agreement.
“EU” shall mean the Member States of the
European Union, as same may change from time to time in terms of
Member States.
“EU Regulatory Application” shall mean any
regulatory application or any other application for approval to
market the Developer Invention in any Member State of the EU,
which Amarin may file in any Member State of the EU, including
any supplements or amendments thereto which Amarin may file.
“EU Regulatory Approval” shall mean the final
approval to market the Developer Invention in any Member State
of the EU, including pricing and reimbursement approval and any
other approval which is required to launch the Developer
Invention in the normal course of business.
“Field” shall mean all indications of any
nature.
4
“FDA” shall mean the United States Food and
Drug Administration or any other successor agency whose approval
is necessary to market the Developer Invention in the USA.
“In Market” means the sale of a Developer
Invention by Amarin to an unaffiliated third party, such as a
wholesaler, managed care organisation, hospital or pharmacy.
“Initial Consideration” shall mean the initial
consideration payable by Amarin to the Developer in accordance
with Clause 5.2.
“Intellectual Property Rights” shall mean all
patents, patent applications, copyrights, copyright
applications, trademarks, trade secrets, know-how and other
intellectual property rights.
“Licence Agreement” shall mean any licence
agreement or
sub-licence
agreement entered into by Amarin with a third party whereby a
licensee or a
sub-licensee,
as applicable, will sell the Developer Invention in the
Territory in the Field.
“Major EU Country” shall mean any one of UK,
France, Germany, Italy and Spain.
“NDA” shall mean a New Drug Application filed
with the FDA, including any supplements or amendments thereto
which may be filed.
“NDA Approval” shall mean the final approval of
an NDA by the FDA to market a product in the USA.
“Net Sales” means aggregate sales amounts
recognised by Amarin from sales by Amarin of the Developer
Invention in Market in accordance with the prevailing
consistently applied generally accepted accounting principles
applicable to Amarin (“GAAP”), less reasonable
and customary deductions from such gross amounts as actually
paid or accrued for by Amarin including, without limitation the
following:
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| | (a)
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trade, cash and quantity discounts allowed, or provided for, and
taken directly with respect to such sales;
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| | (b)
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amounts repaid, credits or allowances granted, or provided for,
for damaged goods, defects, recalls, returns or rejections of
the Developer Invention and retroactive price reductions;
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| | (c)
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sales or similar taxes paid by or charged to the account of
Amarin, or provided for, without offset (including, without
limitation, duties or other governmental charges levied on,
absorbed or otherwise imposed on the sale of the Developer
Invention, value added taxes or other governmental charges
otherwise measured by the billing amount, when included in
billing, but not including national, state or local taxes based
on income);
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| | (d)
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charge back payments and rebates granted, or provided for, to
(i) managed health care organizations, (ii) federal,
state and/or
local governments or their agencies, (iii) purchasers and
reimbursers, or (iv) trade customers, including, without
limitation, wholesalers and chain and pharmacy buying groups;
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| | (e)
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freight, postage, shipping, customs duties and insurance charges
to the extent included in the proceeds received from the
customer; and
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| | (f)
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a deduction in respect of the costs of the Delivery Kit in an
amount equal to the lesser of:
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| | (i)
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the amount payable by Amarin to a third party manufacturer in
respect of the manufacture of the Delivery Kit for commercial
sale (whether comprised of royalties or unit manufacturing
costs); and
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provided however that any payments by Amarin to a third party
manufacturer which relate to the development of the Delivery Kit
prior to the launch of the Developer Invention shall not be
included in calculating this deduction hereunder.
Any Developer Invention provided by Amarin free of charge, for
administration to patients enrolled in clinical trials or
distributed through a
not-for-profit
foundation at no charge to eligible patients
5
would not be included in Net Sales, provided that Amarin
receives no cash consideration from such
not-for-profit
foundation or from such clinical trials or such use of the
Developer Invention.
Net Sales and any factors used in determining Net Sales shall be
determined by Amarin in accordance with GAAP.
“Other Apomorphine Product” shall mean any
product incorporating the Compound, other than the Developer
Invention.
“Proof of Concept Study Data” shall mean all
and any data generated pursuant to the Simbec Study Agreement.
“Regulatory Application” shall mean any EU
Regulatory Application, NDA,
and/or any
other regulatory application or other application for approval
to market the Developer Invention
and/or any
Other Apomorphine Product in any country of the Territory, which
Amarin may file in any country of the Territory, including any
supplements or amendments thereto which Amarin may file.
“Regulatory Approval” shall mean any EU
Regulatory Approval, NDA Approval,
and/or any
other final approval to market the Developer Invention
and/or any
Other Apomorphine Product in any country of the Territory,
including pricing and reimbursement approval and any other
approval which is required to launch the Developer Invention
and/or any
Other Apomorphine Product in any country of the Territory in the
normal course of business.
“RHA” shall mean any relevant government health
authority (or successor agency thereof) in any country of the
Territory whose approval is necessary to market the Developer
Invention
and/or the
Other Apomorphine Products in the relevant country of the
Territory.
“Royalty” or “Royalties” shall mean
the royalties payable by Amarin to the Developer in accordance
with Clause 5.4.
“Simbec Study Agreement” shall mean the
Clinical Research Agreement dated 5 April 2006 between
Amarin, Amarin Neuroscience Ltd. and Simbec Research Ltd.
“Territory” shall mean all countries of the
world.
“Third Party Royalties” shall mean all
royalties received by Amarin pursuant to a Licence Agreement in
respect of sales by a licensee or
sub-licensee
of the Developer Invention, having taken account of deductions
in respect of any customs and excise duties or other sales taxes
that are actually paid by Amarin (but, for the avoidance of
doubt, not income or corporation tax), directly related to the
receipt of such royalties by Amarin.
“Third Party Milestone Payments” shall mean all
upfront or milestone payments received by Amarin pursuant to a
Licence Agreement in respect of the Developer Invention, having
taken account of deductions in respect of any customs and excise
duties or other sales taxes that are actually paid by Amarin
(but, for the avoidance of doubt, not income or corporation
tax), directly related to the receipt of such revenues by Amarin.
‘‘£” shall mean Pounds Sterling.
“US” or “USA” shall mean the
United States of America.
“Valid Claim” means a claim of any issued,
unexpired Developer Patent that has not been revoked or held
unenforceable or invalid by a decision of a court or
governmental agency of competent jurisdiction from which no
appeal can be taken, or with respect to which an appeal is not
taken within the time allowed for appeal, and that has not been
disclaimed or otherwise rendered unenforceable.
2 ASSIGNMENT
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| | 2.1
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In consideration of the payment by Amarin to the Developer of
the Consideration in accordance with the terms of this
Agreement, the Developer as legal and beneficial owner, assigns
to Amarin, its successors
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and assigns, all its right, title and interest in and to the
Developer Intellectual Property, together with all the rights of
action, powers and benefits belonging to the same, including the
right to xxx for and obtain damages and other relief in respect
of any infringement
and/or any
violation of any common law rights (whether past, present or
future) of the Developer Intellectual Property and for Amarin,
its successors and assigns, to hold, use, exercise and enjoy the
same unto Amarin absolutely for the whole period of such rights
for the time being capable of being assigned by the Developer
together with any and all renewals, reversions and extensions
throughout the world.
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| | 2.2
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Without prejudice to the generality of Clause 15.10, the
Developer will, upon the written request of Amarin, execute all
such further assignments, transfers, deeds, documents or other
assurances and do all further acts and things as Amarin may
require in order to enable Amarin to become registered as the
proprietor of the Developer Intellectual Property and otherwise
to secure the benefit of the Developer Intellectual Property
assigned under this Agreement.
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3 DEVELOPER
KNOW-HOW / DEVELOPER IMPROVEMENTS
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| | 3.1
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To the extent that the Developer is prohibited by statute or
otherwise from assigning all current and future rights, title
and interest in the Developer Know-How and the Developer
Improvements to Amarin, the Developer hereby grants Amarin an
exclusive, worldwide, perpetual, fully-paid, royalty-free,
irrevocable licence (with the right to grant sublicenses) to the
Developer Know-How and the Developer Improvements, and any
Intellectual Property Rights therein for all purposes in the
Field.
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| | 3.2
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With effect from the Effective Date, the Developer shall not
research, develop, market or otherwise commercialise the
Developer Know-How
and/or the
Developer Improvements in the Territory except on behalf of
Amarin (whether as an employee of Amarin or otherwise).
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4 DEVELOPMENT
WORK
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| | 4.1
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Amarin shall be responsible for, and have full discretion in
relation to, the design and implementation of a development plan
for the Developer Intellectual Property.
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| | 4.2
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For the avoidance of doubt, the cost of conducting all
development work in relation to the Developer Intellectual
Property and all costs arising under Clause 9.1 shall be
borne by Amarin.
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5 PAYMENTS
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| | 5.1
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The Consideration shall be payable by Amarin to the Developer in
accordance with this Clause 5 during the Consideration
Period.
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5.2 Initial Consideration
Upon the Effective Date, Amarin shall pay to the Developer
£42,000.
5.3 Amarin Milestone Payments
During the Consideration Period, Amarin shall be liable to pay
to the Developer the Amarin Milestone Payments in respect of the
Developer Invention as follows:
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| | 5.3.1
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upon the final selection by Amarin, at its sole discretion
having taken advice from its Scientific Advisory Board, of the
first formulation of the Compound for clinical development of
the Developer Invention, Amarin shall pay to the Developer
£42,000;
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| | 5.3.2
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upon the successful completion by Amarin of the first Pivotal
Bioequivalence Study on the Developer Invention which Amarin is
satisfied, at its sole discretion having taken advice from its
Scientific Advisory Board, will enable it to file an NDA on the
Developer Invention; or upon successful completion of the first
Phase II clinical trial on the Developer Invention which
Amarin is satisfied, at its sole discretion having taken advice
from its Scientific Advisory Board, will enable it to commence a
Phase III clinical trial on the Developer Invention, Amarin
shall pay to the Developer £28,000;
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| | 5.3.3
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upon the filing and acceptance of the first EU Regulatory
Application on the Developer Invention in a Major EU Country, or
under the EMEA centralized procedure, or in any EU country under
the mutual recognition procedure with the objective of EU
Regulatory Approval in a Major EU Country, Amarin shall pay to
the Developer £56,000;
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| | 5.3.4
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upon the filing and acceptance of the first NDA on the Developer
Invention, Amarin shall pay to the Developer £56,000;
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| | 5.3.5
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upon obtaining the first EU Regulatory Approval on the Developer
Invention in a Major EU Country, Amarin shall pay to the
Developer £280,000; and
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| | 5.3.6
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upon obtaining the first NDA Approval on the Developer
Invention, Amarin shall pay to the Developer £280,000.
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For the avoidance of doubt, any one of the Amarin Milestone
Payments above shall become payable by Amarin upon the first
achievement of the relevant milestone in relation to the
Developer Invention, and upon payment of such Amarin Milestone
Payments by Amarin, all of Amarin’s obligations hereunder
to pay such Amarin Milestone Payment shall be satisfied in full.
In the event that any one of the milestones set forth above
should be achieved on more than one occasion in relation to the
Developer Invention (for example, in relation to two separate
therapeutic indications), Amarin shall have no obligation to pay
any Amarin Milestone Payment in relation thereto save the
obligation to pay the Amarin Milestone Payment which arose on
the first achievement of the relevant milestone.
5.4 Royalties on Net Sales / Third Party Royalties
/ Third Party Milestone Payments
During the Consideration Period, Amarin shall be liable to pay
Royalties to the Developer as follows:
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| | 5.4.1
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if Amarin sells the Developer Invention In Market in the
Territory, then on a country by country and product by product
basis:
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| | (a)
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where the Developer Invention is covered by a Valid Claim that
confers market exclusivity for such Developer Invention, or
where Amarin has market exclusivity for the Developer Invention
by virtue of having orphan drug status for such Developer
Invention, payments would be made by Amarin to the Developer as
follows:
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Annual Amount of Net Sales
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in the Territory
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Percentage Payable
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less than $17.5 million
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5%
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$17.5 million to
$87.5 million
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2%
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over $87.5 million
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1%
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or
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| | (b)
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where the Developer Invention is not covered by a Valid Claim
that confers market exclusivity for such Developer Invention or
where Amarin does not have market exclusivity for the Developer
Invention by virtue of having orphan drug status for such
Developer Invention, Amarin shall pay to the Developer, 1% of
Net Sales;
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| | 5.4.2
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Amarin enters into a Licence Agreement then, on a country by
country and product by product basis, Amarin shall pay to the
Developer:
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(a) 7.5% of Third Party Royalties; and
(b) 7.5% of Third Party Milestone Payments.
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| | 5.4.3
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During the Consideration Period, payment of Royalties shall
become due at the end of each calendar quarter following first
commercial sale of the Developer Invention.
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5.5 Royalties on non-cash Third Party Milestone
Payments under a Licence Agreement
With reference to Clause 5.4.2(b), if Amarin enters into a
Licence Agreement where all or part of a Third Party Milestone
Payment payable to Amarin thereunder is in the form of non-cash
consideration (including without limitation, product rights to a
third party product) (“Quid”), Amarin’s
obligations to the Developer shall be as follows:
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| | 5.5.1
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Amarin shall promptly notify the Developer in writing of the
non-cash consideration received or receivable by Amarin and the
financial value that has been assigned thereto by Amarin
(“Quid Value”); and
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| | 5.5.2
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Amarin shall be obliged to pay the Developer 7.5% of the Quid
Value by means of a payment to the Developer at the end of each
calendar quarter following the execution of the Licence
Agreement of 10% of the quarterly revenues generated by Amarin
from the Quid until such time as Amarin’s cumulative
payments to the Developer have reached 7.5% of the Quid Value,
whereupon such obligation shall be satisfied in full and shall
terminate.
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| | 5.6
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For the avoidance of doubt, all of Amarin’s obligations to
pay Consideration to the Developer under this Agreement shall
cease upon the expiry of the Consideration Period
(“Consideration Expiry Date”), save any accrued
obligations of Amarin to pay any amounts of Consideration which
remain due to the Developer on the Consideration Expiry Date.
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6 DEVELOPER
LICENCE AGREEMENTS
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| | 6.1
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Developer shall be responsible for all payments related to the
financial provisions and obligations of any third party
agreement with respect to the Developer Intellectual Property to
which Developer is a party on the Effective Date (including
amendments thereto) (the “Developer Effective Date
Agreements”), including without limitation, any
royalty, milestone or other compensation obligations triggered
thereunder on the Effective Date, or triggered thereunder after
the Effective Date.
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| | 6.2
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For the avoidance of doubt, any royalties, milestone or other
compensation obligations which arise under any Developer
Effective Date Agreement from the process of the
commercialisation or exploitation of the Developer Invention,
the Developer Intellectual Property or any products that
incorporate the same shall be payments for which Developer will
be responsible under this Clause 6.
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7 WARRANTIES
7.1 Developer represents and warrants to Amarin as of
the Effective Date, as follows:
7.1.1 Developer has the right to enter into this Agreement;
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| | 7.1.2
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Developer has obtained all and any other consents required to
enter into this Agreement and perform all its obligations set
forth herein;
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| | 7.1.3
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there are no agreements between Developer and any third party
that conflict with this Agreement;
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| | 7.1.4
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Developer has provided Amarin with copies of any Developer
Effective Date Agreements; and
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| | 7.1.5
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there are no proceedings threatened or pending against Developer
in connection with the Developer Intellectual Property.
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8 INDEMNIFICATION
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| | 8.1
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In addition to any other indemnities provided for in this
Agreement, and subject to Clause 8.3, Developer shall
indemnify and hold harmless Amarin and its Affiliates and their
respective employees, agents, officers and directors from and
against any Claims incurred or sustained by Amarin arising out
of or in connection with any:
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| | 8.1.1
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breach of any representation, covenant, warranty or obligation
by Developer hereunder; or
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| | 8.1.2
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negligent or wilful act or omission or failure to comply with
applicable laws and regulations on the part of Developer or any
of its respective employees, agents, officers and directors in
the performance of this Agreement;
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in each case save to the relative extent that such Claim is
subject to Amarin’s indemnity under Clause 8.2.
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| | 8.2
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In addition to any other indemnities provided for herein, and
subject to Clause 8.3, Amarin shall indemnify and hold
harmless Developer and its Affiliates and their respective
employees, agents, officers and directors from and against any
Claims incurred or sustained by Developer arising out of or in
connection with any:
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| | 8.2.1
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breach of any representation, covenant, warranty or obligation
by Amarin hereunder; or
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| | 8.2.2
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negligent or wilful act or omission or failure to comply with
applicable laws and regulations on the part of Amarin or any of
its agents or employees in the performance of this Agreement;
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in each case save to the relative extent that such Claim is
subject to the Developer’s indemnity under Clause 8.1.
8.3 The party seeking an indemnity shall:
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| | 8.3.1
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fully and promptly notify the other party of any claim or
proceedings, or threatened claim or proceedings;
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| | 8.3.2
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permit the indemnifying party to take full control of such claim
or proceedings, with counsel of the indemnifying party’s
choice, provided that the indemnifying party shall reasonably
and regularly consult with the indemnified party in relation to
the progress and status of such claim or proceedings;
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| | 8.3.3
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co-operate in the investigation and defence of such claim or
proceedings; and
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| | 8.3.4
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take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceedings.
|
Save as aforesaid, neither the indemnifying party nor the party
to be indemnified shall acknowledge the validity of, compromise
or otherwise settle any Claim without the prior written consent
of the other, which shall not be unreasonably withheld.
| | |
| | 8.4
|
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT,
AMARIN AND DEVELOPER SHALL NOT BE LIABLE TO THE OTHER BY REASON
OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR
ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS
AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR
PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE
PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER
OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
EMPLOYEES OR AGENTS OR OTHERWISE.
|
| |
| | 8.5
|
Nothing in this Agreement shall limit the liability of either
party for fraud, or limit the liability of either party to any
third party under applicable laws where any act or omission of
either party results in death or personal injury.
|
9 PATENT
PROSECUTION AND MAINTENANCE
| | |
| | 9.1
|
For the avoidance of doubt, with effect from the Effective Date,
Amarin, at its sole discretion and expense, may:
|
| | |
| | 9.1.1
|
secure the grant of any patent applications within the Developer
Intellectual Property in the Territory;
|
| |
| | 9.1.2
|
file and prosecute patent applications on patentable inventions
and discoveries relating to the same in the Territory;
|
10
| | |
| | 9.1.3
|
defend all such applications against third party oppositions in
the Territory; and
|
| |
| | 9.1.4
|
maintain in force any issued letters patent relating to the same
in the Territory.
|
| | |
| | 9.2
|
The Developer shall provide Amarin with reasonable support in
the filing and prosecution of any patent applications under this
Clause 9 and shall provide all information
and/or data
in the Developer’s possession that is necessary to support
any such patent applications.
|
| |
| | 9.3
|
Developer shall promptly notify Amarin in writing of the
following:
|
| | |
| | 9.3.1
|
any actual or alleged unauthorized use of the Developer
Intellectual Property by a third party of which it becomes aware
and provide Amarin with any available evidence of such
unauthorized use;
|
| |
| | 9.3.2
|
any claim or proceedings alleging infringement or other
unauthorised use of the proprietary rights of a third party
arising from the performance of this Agreement and the conduct
by Amarin of development work in relation to the Developer
Intellectual Property.
|
For the avoidance of doubt, Amarin shall, at its sole
discretion, determine the strategy to be adopted and actions to
be taken in relation to any enforcement or defence action
necessary in relation to the matters set forth above.
10 REGULATORY
MATTERS
| | |
| | 10.1
|
For the avoidance of doubt, Amarin shall, at its expense, be
responsible for the filing and maintaining all Regulatory
Applications and Regulatory Approvals with the RHAs in relation
to the Developer Invention and Other Apomorphine Products.
|
| |
| | 10.2
|
For the further avoidance of doubt Amarin shall own all
Regulatory Applications filed, and Regulatory Approvals obtained
in respect of the Developer Invention and Other Apomorphine
Products.
|
11 SIMBEC
STUDY AGREEMENT
| | |
| | 11.1
|
The parties acknowledge that pursuant to the Simbec Study
Agreement, Amarin owns the Proof of Concept Study Data.
|
12 CONFIDENTIAL
INFORMATION/ANNOUNCEMENTS
| | |
| | 12.1
|
Upon execution of this Agreement, and thereafter during the term
hereof, at such times as the parties shall mutually agree, each
party may disclose to the others, in confidence Confidential
Information necessary or useful to the activities contemplated
by this Agreement.
|
Except as specifically authorised or permitted by this
Agreement, each party shall, for the term of this Agreement and
for 7 years after its expiration or termination keep
confidential and not disclose to others (except its Affiliates),
and use only as permitted hereunder, all of the Confidential
Information owned by the other parties.
For the avoidance of doubt, the parties acknowledge that all
Confidential Information relating to the Developer Intellectual
Property shall upon execution of this Agreement be the absolute
property of Amarin.
| | |
| | 12.2
|
Save as otherwise specifically provided herein, each party shall
disclose Confidential Information of the other parties only to
those employees, representatives and agents requiring knowledge
thereof in connection with fulfilling the party’s
obligations under this Agreement. Each party further agrees to
(i) inform all such employees, representatives and agents
of the terms and provisions of this Agreement relating to
Confidential Information and their duties hereunder, and
(ii) obtain their agreement hereto as a condition of
receiving Confidential Information, provided that such agreement
shall be deemed given in respect of such employees,
representatives and agents that, at the time of disclosure, are
under existing obligations of confidentiality no less onerous
than those contained herein covering such
|
11
| | |
| |
|
disclosure. Each party shall exercise the same standard of care
as it would itself exercise in relation to its own confidential
information (but in no event less than a reasonable standard of
care) to protect and preserve the proprietary and confidential
nature of the Confidential Information disclosed to it by the
other parties.
|
12.3 Notwithstanding the provisions of this
Clause 12, Confidential Information may be:
| | |
| | 12.3.1
|
published if and to the extent such publication has been
approved in writing by each of the parties; or
|
| |
| | 12.3.2
|
disclosed to the extent required by applicable laws or
regulations or as ordered by a court or other regulatory body
having competent jurisdiction, provided that if a party becomes
legally required to disclose any Confidential Information of the
other party hereunder, the receiving party shall give the
disclosing party prompt notice of such requirement to enable the
disclosing party to seek a protective order or other appropriate
remedy concerning any such disclosure. The receiving party shall
fully co-operate with the disclosing party in connection with
the disclosing party’s efforts to obtain any such order or
other remedy. If any such order or other remedy does not fully
preclude disclosure, the receiving party shall make such
disclosure only to the extent that such disclosure is legally
required.
|
| | |
| | 12.4
|
The parties agree that the obligations of this Clause 12
are necessary and reasonable in order to protect the
parties’ respective businesses, and each party agrees that
monetary damages would be inadequate to compensate a party for
any breach by the other party of its covenants and agreements
set forth herein.
|
The parties agree that any such violation or threatened
violation shall cause irreparable injury to a party and that, in
addition to any other remedies that may be available, in law and
equity or otherwise, each party shall be entitled to seek
injunctive relief against the threatened breach of the
provisions of this Clause 12, or a continuation of any such
breach by the other party, specific performance and other
equitable relief to redress such breach together with damages
and reasonable counsel fees and expenses to enforce its rights
hereunder.
| | |
| | 12.5
|
Subject to Clause 12.2 and Clause 12.3.2 and 12.6,
neither party shall have the right to disclose to third parties
the existence of this Agreement or any of the terms and
conditions hereof without the prior written consent of the other
party. In the event that either party wishes to make an
announcement concerning the Agreement, that party will seek the
consent of the other party, which consent shall not be
unreasonably withheld or delayed. The terms of any such
announcement shall be agreed in good faith.
|
| |
| | 12.6
|
Amarin shall be entitled to provide a copy of this Agreement
(and any related agreements or documents) to a potential third
party licensee,
sub-licensee,
acquirer or other party interested in the research, development
or commercialization of the Developer Intellectual Property
provided that the relevant third party has entered into a
confidentiality agreement on terms to be agreed between Amarin
and such relevant third party.
|
13 PAYMENTS,
REPORTS AND AUDITS
| | |
| | 13.1
|
With reference to Clause 5, Amarin shall keep true and
accurate records of Net Sales (and any deductibles made in
calculating same), Third Party Royalties and Third Party
Milestone Payments.
|
| |
| | 13.2
|
Any income or other taxes which Amarin is required by law to pay
or withhold on behalf of the Developer with respect to any
monies payable to the Developer under this Agreement shall be
deducted from the amount of such monies due. Any such tax
required to be paid or withheld shall be an expense of and borne
solely by the Developer. Amarin shall promptly provide the
Developer with a certificate or other documentary evidence to
enable the Developer to support a claim for a refund or a
foreign tax credit with respect to any such tax so withheld or
deducted by Amarin.
|
| |
| | 13.3
|
For the 90 day period following the close of each financial
year, Amarin will, in the event that the Developer reasonably
requests such access, provide the Developer’s independent
certified accountants
|
12
| | |
| |
|
(reasonably acceptable to Amarin) with access, during regular
business hours and subject to the confidentiality provisions as
contained in this Agreement, to Amarin’s books and records
relating to the Developer Invention, solely for the purpose of
verifying the accuracy and reasonable composition of the
calculations hereunder for the financial year then ended.
|
| | |
| | 13.4
|
In the event of a discovery of a discrepancy which exceeds five
per cent (5%) of the amount due for any period, the cost of such
audit shall be borne by Amarin; otherwise, such cost shall be
borne by the Developer.
|
| |
| | 13.5
|
Payment of monies due under this Agreement shall be made by
Amarin to the Developer within 30 days of becoming due.
|
| |
| | 13.6
|
All sums payable by Amarin to the Developer shall be paid in
pounds sterling by wire transfer to the Developer’s
designated account. Where a sum is calculated according to
payments received by Amarin in one or more other currencies, the
pound sterling amount payable shall be calculated by reference
to the average mid-price exchange rate between the local
currencies and the pound sterling over the calendar quarter
during which such payment becomes due by reference to the
applicable rates published in The Financial Times.
|
| | |
| | 13.7
|
Amarin shall pay interest to the Developer on sums not paid to
the Developer on the date on which payment should have been made
pursuant to the applicable provisions of this Agreement
(“Due Date”) over the period from the Due Date
until the date of actual payment (both before and after
judgement) at a rate per annum equal to 1% over the 1 year
LIBOR rate (London Interbank Offer Rate), such interest to
payable on demand from time to time and compounded quarterly.
|
14 CHANGE
OF CONTROL
In the event of a Change of Control of Amarin, the following
obligations upon Amarin shall arise with effect from the date
the Change of Control of Amarin takes effect:
| | |
| | 14.1
|
In the event that the board of directors of Amarin makes a final
determination that Amarin will terminate all further development
and commercialization activities relating to the Developer
Invention in both the EU and the US, Amarin shall notify the
Developer in writing of such determination with 90 days
(“Notification Date”).
|
| |
| | 14.2
|
For a period of 30 days from the Notification Date (the
“Developer Option Period”), Amarin shall grant
the Developer an exclusive option to negotiate an agreement for
the commercialisation by the Developer of the Developer
Intellectual Property in the EU and the US upon terms to be
negotiated, including the consideration to be paid by the
Developer to Amarin based on the market value of the opportunity
(at a minimum) (“Developer Terms”).
|
| |
| | 14.3
|
For the avoidance of doubt, during the Developer Option Period,
Amarin will not negotiate in any form, directly or indirectly,
with any other corporation, entity or person in relation to the
subject matter of Clause 14.2, nor provide any information
relating thereto to third parties, save with the prior consent
in writing of the Developer.
|
| |
| | 14.4
|
If, despite the above negotiations, Amarin and the Developer do
not reach agreement within the Developer Option Period, then
Amarin shall be free to enter into negotiations with third
parties to agree terms (“Third Party Terms”)
upon which a third party would commercialise the Developer
Intellectual Property in the EU
and/or the
US as follows:
|
| | |
| | 14.4.1
|
at any time following the expiry of the Developer Option Period,
without any reference to the Developer, Amarin shall be free to
conclude and execute an agreement with a third party to
commercialise the Developer Intellectual Property in the EU
and/or the
US where the Third Party Terms are more favourable to Amarin
than the Developer Terms; and
|
| |
| | 14.4.2
|
during a period of 6 months from the expiry of the
Developer Option Period, Amarin shall provide prior notice in
writing to the Developer if Amarin proposes to enter into an
agreement
|
13
| | |
| |
|
with a third party to commercialise the Developer Intellectual
Property in the EU
and/or the
US where the Third Party Terms are not more favourable to Amarin
than the Developer Terms (such notice to include full disclosure
of the relevant Third Party Terms) and the Developer shall have
the right, within 30 days of receipt of such notice, to
elect to enter into an agreement with Amarin upon the same terms
and conditions contained in Amarin’s notice to the
Developer.
|
15 MISCELLANEOUS
| | |
| | 15.1
|
This Agreement shall be governed by and construed in accordance
with the laws of England and the parties submit to the
non-exclusive jurisdiction of the English courts.
|
| |
| | 15.2
|
No waiver of any right under this Agreement shall be deemed
effective unless contained in a written document signed by the
party charged with such waiver, and no waiver of any breach or
failure to perform shall be deemed to be a waiver of any future
breach or failure to perform or of any other right arising under
this Agreement.
|
| |
| | 15.3
|
Neither party to this Agreement shall be liable for delay or
failure in the performance of any of its obligations hereunder
to the extent such delay or failure results from causes beyond
its reasonable control, including, without limitation, acts of
God, fires, strikes, acts of war, or intervention of a
government authority, non-availability of raw materials, but any
such delay or failure shall be remedied by such party as soon as
practicable.
|
15.4 The following provisions shall apply to the
assignment of this Agreement:
| | |
| | 15.4.1
|
each party may assign this Agreement in whole or in part and
delegate its duties hereunder to its Affiliate or Affiliates
without consent provided that such assignment or delegation has
no material adverse tax implications for the other
parties; and
|
| |
| | 15.4.2
|
Amarin may assign this Agreement to a third party without the
consent of the Developer.
|
| | |
| | 15.5
|
Nothing contained in this Agreement is intended or is to be
construed to constitute Developer and Amarin as partners or
members of a joint venture. None of the parties hereto shall
have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other
parties or to bind the other parties to any contract, agreement
or undertaking with any third party.
|
| |
| | 15.6
|
No amendment, modification or addition hereto shall be effective
or binding on any party unless set forth in writing and executed
by a duly authorised representative of each of the parties.
|
| |
| | 15.7
|
Any notice to be given under this Agreement shall be sent in
writing in English by overnight courier, registered airmail or
telecopied to:
|
Amarin at:
00 Xxxxxxxx Xxxx,
Xxxxxxxxxx,
Xxxxxx 0.
Telephone: 000 0 0000000
Telefax: 353 1 6699028
14
Developer at:
Scots Xxxxx Xxxxx,
Xxxxxx Xxxx,
Xxxxxxxxxx,
Xxxxxxxxxxx,
XX0 0XX.
Telephone: x00 0000 000000
Telefax: x00 0000 000000
or to such other address(es) and telecopier numbers as may from
time to time be notified by any of the parties to the others
hereunder.
Any notice sent by overnight courier, registered mail or
telecopier shall be deemed to have been delivered upon receipt
by the addressee.
| | |
| | 15.8
|
If any provision in this Agreement is agreed by the parties to
be, or is deemed to be, or becomes invalid, illegal, void or
unenforceable under any law that is applicable hereto:-
|
| | |
| | 15.8.1
|
such provision will be deemed amended to conform to applicable
laws so as to be valid and enforceable or, if it cannot be so
amended without materially altering the intention of the
parties, it will be deleted, with effect from the date of such
agreement or such earlier date as the parties may agree; and
|
| |
| | 15.8.2
|
the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired or affected
in any way.
|
| | |
| | 15.9
|
This Agreement sets forth all of the agreements and
understandings between the parties with respect to the subject
matter hereof, and supersedes and terminates all prior
agreements and understandings between the parties with respect
to the subject matter hereof.
|
| |
| | 15.10
|
At the request of any of the party, the other parties shall (and
shall use reasonable efforts to procure that any other necessary
third parties shall) execute and do all such documents, acts and
things as may reasonably be required subsequent to the signing
of this Agreement for assuring to or vesting in the requesting
party the full benefit of the terms hereof.
|
| |
| | 15.11
|
Each party shall pay its own legal costs in relation to the
negotiation and conclusion of this Agreement.
|
| |
| | 15.12
|
A person who is not a party to this Agreement has no right under
the Contracts (Rights of Third parties) Xxx 0000 to enforce any
term of this Agreement, but this does not affect any right or
remedy of a third party which exists or is available apart from
that Act.
|
15
IN WITNESS WHEREOF, the parties hereto have executed this
Agreement.
SIGNED
for and on behalf of
AMARIN PHARMACEUTICALS IRELAND LIMITED
XXXX XXXXX
SIGNED
by
DR XXXXXXX XXXXXX
XXXXXXX XXXXXX
16
IN WITNESS WHEREOF, the parties hereto have executed this
Agreement.
SIGNED
for and on behalf of
AMARIN PHARMACEUTICALS IRELAND LIMITED
XXXX XXXXX
SIGNED
by
DR XXXXXXX XXXXXX
XXXXXXX XXXXXX
17
SCHEDULE 1
Developer
Patents
| | | |
|
British Patent Application:
|
|
“Pharmaceutical formulation
of Apomorphine”
|
|
|
|
|
|
Name of Inventor:
|
|
Xxxxxxx Xxxxxx, Scots Xxxxx Xxxxx,
Xxxxxxxxxx, XxxxxxxxxxxXX0 0XX, XX.
|
|
|
|
|
|
British Application No.:
|
|
0509317.4
|
|
|
|
|
|
Date of submission:
|
|
6 May 2005
|
18
(1) AMARIN PHARMACEUTICALS IRELAND LIMITED
AND
(2) DR XXXXXXX XXXXXX
ASSIGNMENT AGREEMENT
XXXXXXXX XXXXXX XXXXXXXX
00 Xxxxxxx Xxxxxx
Xxxxxx 0
Xxxxxxx
