AND
Exhibit 4.83
(1) AMARIN
NEUROSCIENCE LIMITED
(2) AMARIN
PHARMACEUTICALS IRELAND LIMITED
AND
(3)
XXXXXXX
RIVER LABORATORIES PRECLINICAL SERVICES EDINBURGH LIMITED
THIS MASTER CLINICAL SERVICES
AGREEMENT (this ‘AGREEMENT’)
BETWEEN:
(1)
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AMARIN NEUROSCIENCES
LTD, having its principal place of business at Magdelen Centre
North, Xxxxxx Xxxxxxx Xxxx, Xxxxxx, XX0 0XX and its Affiliates, (‘Amarin
’);
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(2)
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AMARIN PHARMACEUTICALS IRELAND
LIMITED having its principal place of business at First Floor,
Block 3, The Oval, Xxxxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx 0, Xxxxxxx (“APIL”);
and
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(3)
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XXXXXXX RIVER LABORATORIES
PRECLINICAL SERVICES EDINBURGH LIMITED having its principal place
of business at Elphinstone Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxx, XX00 0XX,
XX and its Affiliates listed on Exhibit A, (“Xxxxxxx
River”).
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RECITALS
A.
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Amarin
is in the business of research, developing, manufacturing and/or
distributing pharmaceutical products. Xxxxxxx River is in the business of
providing clinical trial services, research services, and other services
for the pharmaceutical industries.
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B.
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Amarin
and Xxxxxxx River desire to enter into this Agreement to provide the terms
and conditions upon which Amarin may engage Xxxxxxx River from
time-to-time to provide non-clinical services including toxicology and
other services for individual projects by executing individual Work Orders
(as defined below) specifying the details of the services and the related
terms and conditions.
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NOW, IT IS HEREBY AGREED AS
FOLLOWS in consideration of the mutual covenants contained
herein:
1.
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DEFINITIONS
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1.1.
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“Affiliate” shall mean a
corporation or entity controlling, controlled by, or under the common
control with Amarin or Xxxxxxx River, 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.
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1.2.
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“Amarin Materials” shall
mean the materials provided by Amarin to Xxxxxxx River, as more
particularly described in each Work
Order.
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1.3.
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“Change Order” shall
have the meaning given to the term in Clause
2.3.
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1.4.
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“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.
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1.5.
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“Confidential
Information” shall mean all 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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1.5.1.
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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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1.5.2.
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publicly
known prior to or after disclosure, through no default of the receiving
party;
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1.5.3.
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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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1.5.4.
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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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1.6.
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“Effective Date” shall
mean the date of last signature of this
Agreement.
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2
1.7.
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“Intellectual Property Rights”
shall mean all patents, patent applications, copyrights, copyright
applications, trademarks, trade secrets, know-how and other intellectual
property rights.
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1.8.
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“Project” shall have the
meaning given to the term in Clause
2.2.1.
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1.9.
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“Project Protocol” shall
have the meaning given to the term in Clause
2.2.2.
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1.10.
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“Services” shall have
the meaning given to the term in Clause
2.2.2.
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1.11.
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“Work Orders” shall have
the meaning given to the term in Clause
2.2.1.
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2.
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SCOPE
OF THE AGREEMENT AND WORK ORDERS
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2.1.
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Scope
of Agreement
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2.1.1.
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This
Master Agreement allows the parties to contract for multiple projects
regarding toxicology and other non-clinical services requested by Amarin
and agreed to by Xxxxxxx River through the issuance of multiple Work
Orders in accordance with the terms of this
Agreement.
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2.2.
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Work
Orders/Project Protocol
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2.2.1.
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The
specific details of each project under this Agreement (each a “Project”) shall be
separately negotiated and specified in writing in substantially the form
attached hereto in Appendix 1 (each a “Work
Order”).
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2.2.2.
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The
parties shall agree the terms of a protocol for each Project which will
set out the nature, design and scope of the Project and the schedule of
work to be performed or consulting services to be provided during the
course of each Project (the “Services”) (the “Project
Protocol”).
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2.2.3.
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Each
Work Order will include details of the Services as set out in the relevant
Project Protocol, time line, budget and payment schedule for the Services
to be provided for each Project.
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2.2.4.
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For
the avoidance of doubt, the terms of any Project Protocol are hereby
incorporated into the relevant Work Order and any reference to any Work
Order includes the terms of any Project Protocol set out
therein.
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2.2.5.
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Each
Work Order upon execution shall be incorporated into this Agreement and
shall be subject to all of the terms and conditions of this Agreement, in
addition to the specific details set forth in the Work
Order.
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2.2.6.
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To
the extent any terms or provisions of a Work Order conflict with the terms
and provisions of this Agreement, the terms and provisions of this
Agreement shall prevail, except to the extent that the applicable Work
Order expressly and specifically states an intent to supersede the
Agreement on a specific matter.
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2.3.
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Change
Orders
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2.3.1.
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Subject
to Clause 2.4, any material change in the details of a Work Order,
including without limitation any change to the relevant Project protocol,
shall require written amendment to the Work Order in substantially the
form attached hereto in Appendix 2 (a “Change
Order”).
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2.3.2.
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For
the avoidance of doubt, other than as provided in Clauses 2.3.1 and 2.4,
no other changes to, or deviations from, a Work Order, including without
limitation the relevant Project protocol, can be made without the prior
written consent of Amarin.
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2.3.3.
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Each
Change Order shall detail the requested changes to the applicable task,
responsibility, duty, budget, time line or other
matter.
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2.3.4.
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The
Change Order will become effective upon the execution of the Change Order
by both parties.
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2.3.5.
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Both
parties agree to act in good faith and promptly when considering a Change
Order requested by the other
party.
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3
2.4.
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Conduct
of the Project
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2.4.1.
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Xxxxxxx
River shall provide the Services in accordance with the relevant Project
Protocol, industry standards of professional conduct, and the terms and
conditions of this Agreement.
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2.4.2.
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Emergency
Deviations from Project Protocol
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(a)
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Deviations
from a Project Protocol may be made without Amarin’s approval in an
emergency where issues of safety or welfare arise (“Emergency
Deviations”).
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(b)
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Additional
costs may be incurred by Xxxxxxx River as a result of such Emergency
Deviations which could not have been foreseen at the time of the
preparation of the Work Order (the “Additional
Cost”).
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(c)
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Xxxxxxx
River shall use commercially reasonable efforts to obtain Amarin’s
approval before implementing such Emergency Deviations and incurring such
Additional Cost. Should Xxxxxxx River be unable to contact Amarin prior to
the implementation of the Emergency Deviation, Amarin agrees that Xxxxxxx
River may proceed accordingly and be entitled to recover such Additional
Costs from Amarin upon presentation of an explanation of such Emergency
Deviations and the necessity thereof, together with any additional
information required by Amarin.
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3.
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MATERIALS
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3.1.
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Amarin
shall provide Xxxxxxx River with the Amarin Materials specified in the
applicable Work Order,as well as such complete and accurate data as is
necessary to apprise Xxxxxxx River of the identity, strength, purity,
stability and composition or other appropriate characteristics of each
batch, proper storage and safe handling requirements of the Amarin
Materials, including a Material Safety Data Sheet (MSDS) or equivalent
documentation.
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3.2.
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All
costs associated with the shipping of the Amarin Materials to Xxxxxxx
River shall be the responsibility of Amarin and Xxxxxxx River shall not be
responsible for any loss, damage or destruction of the Amarin Materials in
transit. Title to the Amarin Materials shall at all times
remain in Amarin.
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3.3.
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Xxxxxxx
River acknowledges that Amarin owns the Amarin
Materials.
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3.4.
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Xxxxxxx
River undertakes that it shall not, without the prior written consent of
Amarin:
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3.4.1.
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use
the Amarin Materials for any purpose other than for the Services described
in the applicable Work Order;
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3.4.2.
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make
any Amarin Materials available to a third
party;
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3.4.3.
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allow
access to the Amarin Materials by any employees or permitted consultants
except those who are directly involved in providing the Services in the
Applicable Work Order;
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3.4.4.
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make
any commercial use of the Amarin Materials or any composition made using
the Amarin Materials;
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3.4.5.
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analyse
or otherwise attempt to determine the composition of the Amarin Materials
except as agreed by the parties for the completion of the
Projects;
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3.4.6.
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use
the Amarin Materials for testing in or treatment of human
subjects.
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3.5.
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Subject
to Clause 4, upon termination of the applicable Work Order or of this
Agreement, any remaining Amarin Materials shall be returned by Xxxxxxx
River to Amarin or, at Amarin’s option, destroyed, with written
certification of such destruction.
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3.6.
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Except
as otherwise set forth herein, the Amarin Materials are provided by Amarin
on an as-is basis and without warranty, express or implied, including any
warranty as to merchantability, title, or fitness for a particular
purpose.
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4
4.
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SAMPLES
AND RECORDS RETENTION
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4.1.
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Xxxxxxx
River shall archive all raw material, non-clinical supply and analytical
samples (the “Samples”) and all
books, records, data, reports, pictures and other documents (both in
electronic and paper form) relating to the manufacture and supply of the
Products (the “Records”) in accordance
with the provisions of the relevant Project protocol and with Xxxxxxx
River’s standard archiving terms and conditions attached hereto as
Appendix 3 (the “Retention
Period”). To the extent any terms or provisions of such
terms and conditions conflict with the terms and provisions of this
Agreement, the terms and provisions of this Agreement shall
prevail.
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4.2.
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The
Parties agree that all Records shall constitute Confidential Information
of Amarin and the provisions of Clause 6 shall apply to all such
Records.
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4.3.
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Upon
expiry of the Retention Period, Xxxxxxx River shall provide all original
Records (both in electronic and paper form), and all copies thereof, to
Amarin and shall, at the direction and written request of Amarin, either
deliver all Samples to Amarin, or dispose of same, (unless such Samples
are otherwise required to be stored or maintained by Xxxxxxx River as a
matter of law or regulation).
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5.
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PAYMENT
OF FEES AND EXPENSES
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5.1.
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APIL
(or APIL’s nominee) shall pay Xxxxxxx River fees and reasonable and
necessary vouched expenses incurred in the performance of the Services on
the following basis:
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5.1.1.
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the
total cost of each Project and an estimate of the total expenses to be
incurred in relation thereto (the “Total Project Cost”)
shall be set out in the relevant Work Order and, subject to Clause 2.4, in
no event shall APIL (or APIL’s nominee) be required to pay any amount
exceeding the Total Project Cost unless otherwise agreed in writing by
both parties by Change Order(s);
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5.1.2.
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in
the case of any individual expense item exceeding £500, APIL’s (or APIL’s
nominee) prior written approval must be given for such
expense.
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5.2.
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Invoices
for fees and expenses shall be issued on a monthly basis and APIL (or
APIL’s nominee) shall pay each invoice within thirty (30) days of date of
invoice.
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5.3.
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All
sums referred to in each Work Order shall be exclusive of Value Added Tax
(VAT) and shall be paid by APIL (or APIL’s
nominee).
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5.4.
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If
any portion of an invoice is disputed, then APIL (or APIL’s nominee) shall
pay the undisputed amounts and the parties shall use good faith efforts to
reconcile the disputed amount as soon as
practicable.
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5.5.
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All
amounts not paid by APIL when due shall accrue interest from the
applicable due date until paid, at the rate of one percent (1%) per month.
Xxxxxxx River may elect to cease or suspend Services or withhold required
reports or other deliverables if APIL does not make undisputed payments
when due and payable.
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6.
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CONFIDENTIAL
INFORMATION/ANNOUNCEMENTS
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6.1.
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Upon
execution of this Agreement, and thereafter during the term hereof, Amarin
may disclose to Xxxxxxx River in confidence Confidential Information
necessary or useful to the activities contemplated by this
Agreement.
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6.2.
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Except
as specifically authorised or permitted by this Agreement, Xxxxxxx
River shall,
for a period of 10 years after termination of the applicable Work Order
keep confidential and not disclose to others (except its Affiliates), and
use only as permitted hereunder, all of the Confidential Information owned
by Amarin.
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6.3.
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The
parties agree that the provisions of this Clause 6 shall apply to any
Confidential Information of Amarin provided to Xxxxxxx River prior to the
Effective Date and to any Confidential Information of Xxxxxxx River
provided to Amarin.
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5
6.4.
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Save
as otherwise specifically provided herein, Xxxxxxx River shall disclose
Confidential Information of Amarin only to those employees,
representatives and agents requiring knowledge thereof in connection with
fulfilling Xxxxxxx River obligations under this
Agreement. Xxxxxxx River 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
disclosure. Xxxxxxx River 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
Amarin.
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6.5.
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Notwithstanding
the provisions of this Clause 6, Confidential Information may be 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 Xxxxxxx River becomes legally required to disclose any
Confidential Information of Amarin hereunder, Xxxxxxx River shall give
Amarin prompt notice of such requirement to enable Amarin to seek a
protective order or other appropriate remedy concerning any such
disclosure. Xxxxxxx River shall fully co-operate with Amarin in connection
with Amarin’s efforts to obtain any such order or other
remedy. If any such order or other remedy does not fully
preclude disclosure, Xxxxxxx River shall make such disclosure only to the
extent that such disclosure is legally
required.
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6.6.
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The
parties agree that the obligations of this Clause 6 are necessary and
reasonable in order to protect Amarin’s business, and Xxxxxxx River agrees
that monetary damages would be inadequate to compensate Amarin for any
breach by Xxxxxxx River of its covenants and agreements set forth
herein.
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6.7.
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The
parties agree that any such violation or threatened violation shall cause
irreparable injury to Amarin and that, in addition to any other remedies
that may be available, in law and equity or otherwise, Amarin shall be
entitled to seek injunctive relief against the threatened breach of the
provisions of this Clause 6, or a continuation of any such breach by
Xxxxxxx River, specific performance and other equitable relief to redress
such breach together with damages and reasonable counsel fees and expenses
to enforce its rights hereunder.
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6.8.
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Subject
to Clauses 6.4 and 6.5, Xxxxxxx River shall not be entitled to disclose to
third parties the existence of this Agreement or any of the terms and
conditions hereof without the prior written consent of
Amarin.
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6.9.
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Amarin
shall be entitled to provide a copy of this Agreement (and any related
agreements or documents) to a potential third party acquirer or other
commercialization partner provided that the relevant third
party has entered into a confidentiality agreement on terms to be agreed
between Amarin and such relevant third
party.
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7.
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DATA
AND INTELLECTUAL PROPERTY RIGHTS
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7.1.
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Any
inventions and/or techniques for carrying out the Services hereunder which
relate to the conduct of Xxxxxxx River’s business that are not developed
hereunder and that are not developed using the Confidential Information of
Amarin are and shall remain Xxxxxxx River’s exclusive property, including
but not limited to present and future documentation, scientific and
technical data, test procedures and other information that is owned or
licensed by Xxxxxxx River.
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7.2.
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Xxxxxxx
River shall have the right to use Control Data as part of its general
historical database. “Control Data” shall
mean data generated solely from the control animals used in the relevant
Project.
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7.3.
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All
Intellectual Property Rights conceived, discovered, developed, made,
produced or created as a result of performing the Services and all rights
therein (the “Project
IP”), shall be owned exclusively by APIL (or APIL’s nominee) or an
Affiliate of APIL (or APIL’s
nominee).
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7.4.
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Xxxxxxx
River agrees to promptly disclose all such Project IP to APIL (or APIL’s
nominee) and hereby assigns to APIL (or APIL’s nominee) all right title
and interest in and to all Project
IP.
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6
7.5.
|
All
data and information generated or derived by or Xxxxxxx River as the
result of Services performed by Xxxxxxx River under this Agreement,
including the Reports, and all rights therein (the “Project Results”) shall
be owned exclusively by APIL (or APIL’s
nominee).
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7.6.
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Xxxxxxx
River hereby assigns to APIL (or APIL’s nominee) all rights, title and
interest in and to all Project
Results.
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7.7.
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Subject
to Clause 7.2, Xxxxxxx River shall not be entitled to use the Project
Results or Project IP after the termination or expiry of the relevant Work
Order under which such Project Results or Project IP were created for any
purpose whatsoever without the prior written consent of
Amarin.
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7.8.
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Xxxxxxx
River represents and warrants that each employee, agent, developer,
consultant and contractor who has access to, contributes to, or
participates in the creation of any Project Results or Project IP
hereunder during the term of this Agreement is bound by confidentiality
obligations that protect the confidentiality of such Project Results and
Project IP and shall execute an assignment or an agreement to assign in
favour of Xxxxxxx River all such person’s right, title and interest in the
Project Results and Project IP.
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7.9.
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For
the avoidance of doubt, APIL (or APIL’s nominee) may use the Project
Results and Project IP without any restriction or additional
compensation.
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7.10.
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At
APIL’s cost and expense, at the completion of Services by Xxxxxxx River,
all Project Results and Project IP and other materials owned by APIL (or
APIL’s nominee), regardless of the method of storage or retrieval, shall
either be delivered to APIL (or APIL’s nominee) disposed of, at the
direction and written request of APIL (or APIL’s nominee) (unless such
Project Results or materials are otherwise required to be stored or
maintained by Xxxxxxx River as a matter of law or
regulation).
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7.11.
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Reports
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7.11.1.
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Xxxxxxx
River will provide Amarin with regular updates by telephone and/or by
email on the progress of each Project in a timely manner and as
needed.
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7.11.2.
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On
completion of each Project, Xxxxxxx River will provide draft and final
reports in writing on the Services conducted (each a “Report”) to Amarin in
accordance with the relevant Project
protocol.
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7.11.3.
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Xxxxxxx
River shall not disclose or publish any Report prepared for Amarin, or use
the Reports for any purpose other than to perform its obligations
hereunder, without the prior written consent of
Amarin.
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8.
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REGULATORY
COMPLIANCE
|
8.1.
|
Xxxxxxx
River represents and warrants that all Services will be conducted in
compliance with all applicable laws, rules and regulations, including
without limitation Good Laboratory Practice (GLP) and Good Clinical
Practice (GCP) regulations and guidelines as appropriate, and in
compliance with the applicable International Committee of Harmonization
guidelines, United Kingdom Medicines and Healthcare Products Regulatory
Agency (MHRA) guidelines, and the United States Food and Drug
Administration’s Code of Federal Regulations Title 21, parts 11, 50, 56,
54, 58, and 312 and all other applicable laws, regulations and guidelines,
including for the avoidance of doubt, all laws, regulations and guidelines
relating to data protection.
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8.2.
|
If
any governmental or regulatory authority gives any party any notice to
take any regulatory action with respect to any Project or Services
provided under this Agreement, the notified party shall promptly notify it
to the other party, and both parties shall cooperate in answering such
regulatory action.
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8.3.
|
Upon
reasonable advance notice and at such times as shall be agreed with
Xxxxxxx River, such agreement not to be unreasonably withheld or delayed,
Xxxxxxx River shall make (and where relevant shall procure that any
permitted subcontractor shall make) that portion of its facility where the
Services are conducted available for inspection by Amarin’s duly qualified
employee, or by a duly qualified consultant, contractor or agent of
Amarin, or by the relevant governmental or regulatory
authority. The investigation shall be limited to determining
whether there is compliance with GCP and other requirements of any
applicable laws, regulations and
guidelines.
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7
8.4.
|
Xxxxxxx
River shall provide the Amarin with a list of all of Xxxxxxx River
standard operating procedures (“SOPs”) relevant to the
Services. Amarin shall be entitled to review all such SOPs
during an audit of the Xxxxxxx River
facility.
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8.5.
|
Xxxxxxx
River shall promptly notify Amarin of any material breach of any
applicable laws, regulations or guidelines or SOPs that could potentially
invalidate any Project.
|
9.
|
REPRESENTATIONS
AND WARRANTIES
|
9.1.
|
Xxxxxxx
River represents and warrants as
follows:
|
9.1.1.
|
it
will render the Services under this Agreement and any Work Order in
accordance with applicable professional standards and will make
commercially reasonable efforts to produce a consistently high level of
accuracy and expertise, and in accordance with the terms of this
Agreement;
|
9.1.2.
|
personnel
assigned to perform Services under this Agreement and any Work Order shall
have the skills necessary to efficiently perform such Services in
accordance with the terms of this
Agreement;
|
9.1.3.
|
it
shall make its commercially reasonable efforts to provide the Services in
accordance with the time lines set out in the relevant Work
Orders;
|
9.1.4.
|
it
is not a party to any agreement which would prevent it from fulfilling its
obligations under this Agreement and that during the term of this
Agreement, Xxxxxxx River agrees that it will not enter into any agreement
to provide services which would in any way prevent it from providing
Services contemplated under this Agreement and any Work
Order.
|
9.2.
|
THE
WARRANTIES BY XXXXXXX RIVER SET FORTH IN THIS SECTION ARE IN LIEU OF ANY
AND ALL OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED OR STATUTORY
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OR FOR NON-INFRINGEMENT OF A PATENT,
TRADEMARK OR OTHER INTELLECTUAL PROPERTY
RIGHT.
|
9.3.
|
Amarin
warrants that it owns, licences or controls, or is otherwise entitled to
use, all rights, title and interest in the Amarin Materials and the
intellectual property related
thereto.
|
10.
|
INDEMNIFICATION
|
10.1.
|
Subject
to Clause 10.3, Amarin shall indemnify and hold harmless Xxxxxxx River and
its Affiliates and their respective employees, agents, officers and
directors from and against any Claims incurred or sustained by Xxxxxxx
River and its Affiliates and their respective employees, agents, officers
and directors arising out of the Services performed under this Agreement
including without limitation any Claims arising
from:
|
10.1.1.
|
the
research, development, manufacture, distribution, use, sales or other
disposition by Amarin or APIL of the Amarin Materials;
or
|
10.1.2.
|
any
personal injury sustained by an Amarin employee, agent, officer, or
consultant related to contact with animals, tissues, samples or specimens
during visits to Xxxxxxx River’s facilities or after delivery of any
animals, tissues, samples or specimens to
Amarin;
|
except to the extent such Claims arise out of, or are connected with
any:
10.1.3.
|
breach
of any representation, covenant, warranty or obligation by Xxxxxxx
River under this Agreement;
or
|
10.1.4.
|
negligent
act or omission or wilful misconduct on the part of Xxxxxxx River or any
of its agents or employees in the performance of this
Agreement;
|
8
10.2.
|
Subject
to Clause 10.3, Xxxxxxx River 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 and
its Affiliates and their respective employees, agents, officers and
directors arising out of or in connection with
any:
|
10.2.1.
|
breach
of any representation, covenant, warranty or obligation by Xxxxxxx River
under this Agreement; or
|
10.2.2.
|
negligent
act or omission or wilful
misconduct on the part of Xxxxxxx River or any of its respective
employees, agents, officers and directors in the performance of this
Agreement;
|
10.3.
|
The
party seeking an indemnity shall:
|
10.3.1.
|
fully
and promptly notify the other party of any claim or proceedings, or
threatened claim or proceedings;
|
10.3.2.
|
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;
|
10.3.3.
|
co-operate
in the investigation and defence of such claim or proceedings;
and
|
10.3.4.
|
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.
10.4.
|
NOTWITHSTANDING
ANYTHING TO THE CONTRARY IN THIS AGREEMENT, AMARIN AND XXXXXXX RIVER 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.
|
10.5.
|
Xxxxxxx
River’s liability under this Agreement, regardless of the form of action,
shall not exceed the total amount paid under the Work Order under which
such liability arises.
|
10.6.
|
Intentionally
omitted
|
10.7.
|
Subject
to Clause 10.2, in no event shall Xxxxxxx River be liable for any damages
arising from or in connection with any decision by Amarin or APIL or any
third party to further research, develop or market the Amarin Materials or
any derivative or product or service related thereto or the use of the
Amarin Materials or any product or derivative or service related
thereto.
|
10.8.
|
Insurance
|
10.8.1.
|
Xxxxxxx
River shall, at its own cost and expense, obtain and maintain in full
force and effect the following insurance during the term of this
Agreement:
|
(a)
|
General
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to $5,000,000;
|
(b)
|
Employers
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to $13,000,000 per
accident;
|
(c)
|
Products
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to $5,000,000;
|
9
(d)
|
Professional
Services Errors & Omissions Liability Insurance with per-occurrence
limit of not less than an amount equivalent to
$5,000,000.
|
10.8.2
|
Amarin
shall, at its own cost and expense, obtain and maintain in full force and
effect the following insurance during the term of this
Agreement:
|
(a)
|
General
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €5,000,000;
|
(b)
|
Employers
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €13,000,000 per
accident;
|
(c)
|
Products
Liability Insurance with a per-occurrence limit of not less than an amount
equivalent to €5,500,000.
|
10.8.3
|
Each
party shall furnish certificates of insurance evidencing the required
insurance policies to the other as soon as practicable after the Effective
Date and within 30 days after renewal of such policies. In the
event that any of the required policies of insurance are written on a
claims made basis, then each party shall use reasonable endeavours to
ensure that such policies shall be maintained during the entire Term and
for a period of not less than 3 years following the expiration or
termination of this Agreement. Each insurance policy that is
required under this Agreement shall be obtained from an insurance carrier
with an A.M. Best rating of at least A-VII. Each party shall
notify the other party in writing at least 30 days prior to the expiration
or termination of such coverage. Each party shall ensure that
each of the required policies include a general indemnity to principal
clause.
|
11.
|
PUBLICATION
|
11.1.
|
It
is acknowledged and agreed by Xxxxxxx River that publication of the
Project Results or Project IP in whole or in part shall be within the sole
and absolute discretion of Amarin, and that Xxxxxxx River shall not
publish or refer to any Project Results or Project IP, in whole or in
part, without the prior expressed written consent of Amarin. Neither party
will use the other party's name in connection with any publication or
promotion without the other party's prior, written
consent.
|
12.
|
TERMINATION
|
12.1.
|
This
Agreement shall commence on the Effective Date and shall continue for five
(5) years or until terminated by either party in accordance with this
Clause 12.
|
12.2.
|
This
Agreement or any Work Order may be terminated without cause by Amarin at
any time during the term of the Agreement on thirty (30) days prior
written notice to Xxxxxxx River.
|
12.3.
|
In
addition to the rights of termination provided for elsewhere in this
Agreement, each party shall be entitled forthwith to terminate this
Agreement by written notice to the others
if:
|
12.3.1.
|
either
party commits any material breach of any provisions of this agreement, and
in the case of a breach capable of remedy, fails to cure the same within
30 days after receipt of a written notice giving full particulars of the
breach and requiring it to be cured;
or
|
12.3.2.
|
any
party goes into liquidation (except for the purposes of amalgamation or
reconstruction and in such manner that the company resulting therefrom
effectively agrees to be bound by or assume the obligations imposed on
such party under this Agreement);
or
|
12.3.3.
|
an
encumbrancer takes possession or a receiver is appointed over any of the
property or assets of the any party;
or
|
12.3.4.
|
any
proceedings are filed or commenced by any party under bankruptcy,
insolvency or debtor relief laws or anything analogous to any of the
foregoing under the laws of any jurisdiction occurs in relation to such
party.
|
10
12.3.5.
|
For
the purposes of Clause 12.3.1, a breach will be considered capable of
being cured if the party in breach can comply with the provision in
question in all respects other than as to time of performance (provided
that time of performance is not of the
essence).
|
12.4.
|
The
written termination notice shall identify the specific Work Order or Work
Orders that are being terminated.
|
12.5.
|
Upon
receipt of a termination notice from Xxxxxx, Xxxxxxx River shall cease
performing any work not necessary for the orderly close out of the
affected Projects or for the fulfillment of regulatory
requirements.
|
12.6.
|
In
case of termination of this Agreement or any Work Order after the
completion of a certain Work Order and before the commencement of any
activities by Xxxxxxx River for a subsequent Work Order, then Amarin shall
not be required to make any payment to Xxxxxxx River for such subsequent
Work Order.
|
12.7.
|
In
the event this Agreement or a particular Work Order is terminated before
any such Work Order is completed, Amarin shall pay Xxxxxxx River for all
Services performed in accordance with any such affected Work Order
hereunder, and reimburse Xxxxxxx River for all reasonable and necessary
expenses to which Xxxxxxx River has committed in performing those Services
and which cannot be cancelled, as evidenced in writing by Xxxxxxx River,
together with any additional information required by
Amarin.
|
12.8.
|
Upon
the termination of this Agreement or any Work Order, Xxxxxxx River shall
deliver to Amarin all data and materials provided by Amarin to Xxxxxxx
River for the conduct of Services under the terminated Work Orders, and
Xxxxxxx River shall also deliver to Amarin all Project Results and any
other data, information and documentation produced as the result of
Services performed by Xxxxxxx River under the terminated Work Orders in
accordance with Clause 7.10.
|
13.
|
MISCELLANEOUS
|
13.1.
|
This
Agreement shall be governed by and construed in accordance with the laws
of England.
|
13.2.
|
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.
|
13.3.
|
Other
than with respect to the payment of any amounts due hereunder, 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.
|
13.4.
|
Xxxxxxx
River shall not subcontract with a third party to perform the Services
without the prior written consent of Amarin, which consent shall not be
unreasonably withheld. Should Xxxxxxx River subcontract with any third
party upon such written consent of Xxxxxx, Xxxxxxx River represents and
warrants that such third-party subcontractor shall comply with all
obligations of Xxxxxxx River under this Agreement and any Work Order,
including but not limited to, obligations of confidentiality and ownership
rights of the Project Results and Project IP, and Xxxxxxx River shall
remain fully liable for its and such third party’s performance of the
Services and the obligations of Xxxxxxx River
hereunder.
|
13.5.
|
Amarin
may assign this Agreement to an Affiliate or a third party without the
consent of Xxxxxxx River. Xxxxxxx River shall not be entitled
to assign this Agreement.
|
13.6.
|
Nothing
contained in this Agreement is intended or is to be construed to
constitute Xxxxxxx River and Amarin as partners or members of a joint
venture. None of the parties hereto shall have
any
|
11
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.
13.7.
|
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.
|
13.8.
|
Any
notice to be given under this Agreement shall be sent in writing in
English by overnight courier, registered airmail or telecopied
to:
|
If
to Amarin OR
APIL:
|
Xxxxxx
Xxxxx
|
Amarin
Neuroscience Ltd
|
|
0xx
Xxxxx
|
|
Xxxxxxxx
Xxxxxx Xxxxx
|
|
The
Xxxxxx Xxxxxxx Xxxx
|
|
Xxxxxx
|
|
X0
0XX
|
|
Tel: x00
(0)0000 000000
|
|
Fax: x00
(0)0000 000000
|
|
Email:xxxxxx.xxxxx@xxxxxxxxxx.xxx
|
|
If
to XXXXXXX
RIVER:
|
to
the address set forth on Exhibit A
|
13.8.1.
|
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.
|
13.8.2.
|
Any
notice sent by overnight courier, registered mail or telecopier shall be
deemed to have been delivered upon receipt by the
addressee.
|
13.9.
|
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:
|
13.9.1.
|
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
|
13.9.2.
|
the
validity, legality and enforceability of the remaining provisions of this
Agreement shall not be impaired or affected in any
way.
|
13.10.
|
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.
|
|
13.11.
|
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.
|
13.12.
|
The
provisions of Clauses 3.3, 4, 6, 7, 8, 9, 10, 11, 13.1, 13.11, 13.13, 15
and this Clause 13.12 shall survive the termination of this Agreement or
any Work Order.
|
13.13.
|
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.
|
14.
|
Employee
Solicitation. Amarin agrees that, during the term of a
Work Order and for a period of one hundred eighty (180) days thereafter,
Amarin will not solicit for hire or hire as an employee, or engage as an
independent contractor, any employee of Xxxxxxx River who has been
involved in rendering services on the Services, without the prior written
consent of Xxxxxxx River. In the event of such solicitation, hiring or
engagement, in addition to any other remedy Xxxxxxx River may have, Amarin
shall pay to Xxxxxxx River an amount equal to such employee’s annual
salary.
|
12
15.
|
Dispute
Resolution.
|
15.1.
|
Any
controversy, claim or dispute arising out of this Agreement shall first be
submitted in writing by both parties to the Chief Executive Officer of
Amarin and the Chief Executive Officer of Xxxxxxx River for resolution,
who may call on others to advise them as they see
fit.
|
15.2.
|
If
they fail to resolve the dispute within twenty-eight (28) days of such
submission, any such dispute shall be finally settled by arbitration in
London, United Kingdom, in accordance with the rules of the International
Chamber of Commerce (ICC) then in effect, by
three (3) commercial arbitrators with substantial experience in the
pharmaceutical field.
|
15.3.
|
Each
party shall appoint one arbitrator who at their turn shall nominate the
chairperson, who shall be qualified in English law. If a Party
does not appoint its arbitrator within fifteen (15) days following the
expiry of the twenty-eight (28) day period, then such arbitrator shall be
selected on an expedited basis in accordance with the rules of the
ICC. Any arbitrator so selected shall have substantial
experience in the pharmaceutical
industry.
|
15.4.
|
The
arbitrators shall have the authority to allocate between the parties the
costs of arbitration (including service fees, arbitrator fees and all
other fees related to the arbitration) in such equitable manner as the
arbitrators may determine.
|
15.5.
|
The
scope of the authority of the arbitrators is limited to the strict
application of law.
|
15.6.
|
The
parties shall make sure that, except as may be otherwise required by law,
its witnesses or the arbitrators will not disclose the existence, content
or results of the arbitration hereunder without the prior written consent
of the other party.
|
15.7.
|
The
prevailing party in the arbitration shall be entitled to receive
reimbursement of its reasonable expenses (including reasonable attorneys’
fees, expert witness fees and all other expenses) incurred in connection
therewith.
|
15.8.
|
Judgment
upon the award so rendered may be entered in a court having jurisdiction
or application may be made to such court for judicial acceptance of any
award and an order of enforcement, as the case may
be.
|
13
IN WITNESS WHEREOF, the
parties hereto have executed this Agreement.
SIGNED
for and
on behalf of
AMARIN
NEUROSCIENCE LIMITED
DATE:
SIGNED
for and
on behalf of
AMARIN
PHARMACEUTICALS IRELAND LIMITED
DATE:
SIGNED
for and
on behalf of
XXXXXXX
RIVER LABORATORIES PRECLINICAL SERVICES EDINBURGH LIMITED
DATE:
14
APPENDIX
1
WORK
ORDER
This
WORK ORDER dated as of
the date of last signature below
BETWEEN
(1)
|
AMARIN NEUROSCIENCE LTD
of 0xx
Xxxxx, Xxxxxxxx Xxxxxx Xxxxx, The Xxxxxx Xxxxxxx Xxxx, Xxxxxx, XX0 0XX
(“Amarin”)
|
(2)
|
AMARIN PHARMACEUTICALS IRELAND
LIMITED having its principal place of business at First Floor,
Block 3, The Oval, Xxxxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx 0, Xxxxxxx (“APIL”)
|
(3)
|
XXXXXXX RIVER LABORATORIES
PRECLINICAL SERVICES EDINBURGH LIMITED having its principal place
of business at Elphinstone Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxx, XX00 0XX,
XX ("Xxxxxxx River
")
|
WHEREAS
A
|
Amarin,
APIL and Xxxxxxx River are bound by the terms of the Master Services
Agreement dated XXXX 2007 between Amarin and Xxxxxxx River (the "Master Services
Agreement").
|
B
The terms and conditions of the Master Services Agreement govern this Project
Work Order in respect to the following project, [ insert description of
project] (the “Project”), with the following
additional provisions applying:
Schedule
1 Project Protocol
Schedule
2 Timelines
Schedule
3 Budget and Payment Schedule
Schedule
4: Budget Breakdown
This Work
Order has an Effective Date as of the last date of signature and will remain
valid until completion of Services described herein and when Amarin has paid the
final invoice in accordance with the terms of the Master Services
Agreement.
AGREED AND ACCEPTED by the
parties:
For and
on behalf of Amarin
Neuroscience Ltd
Signed:
...................................................
|
Date:
..............................................
|
Name: ....................................................
|
Position:
.........................................
|
For and
on behalf of Amarin
Pharmaceuticals Ireland Limited
Signed:
...................................................
|
Date:
..............................................
|
Name: ....................................................
|
Position:
.........................................
|
for and
on behalf of Xxxxxxx River Laboratories
Preclinical Services Edinburgh Limited.
Signed:
....................................................
|
Date:
................................................
|
Name:
.....................................................
|
Position:
..........................................
|
15
SCHEDULE 1-: PROJECT
PROTOCOL
16
SCHEDULE 2-:
TIMELINES
[Insert
details]
Critical
Milestones
|
Estimated
Date
|
17
SCHEDULE 3: BUDGET AND
PAYMENT SCHEDULE
·
|
All
invoices will be issued in Pound Sterling and are to be paid in Pound
Sterling.
|
·
|
The
total cost for the Services detailed in this Work Order is
[ ] and the total estimated related expenses have
been detailed in Schedule 4.
|
·
|
The
authorised Amarin contact shall be Xxxxxx Xxxxx. The authorised Xxxxxxx
River contact for this work shall be
[ ].
|
·
|
All
invoices will state the Amarin protocol number, activity performed,
purchase order number (if available), contact name and will be submitted
to the following address:
|
Amarin
Neurosciences Ltd
0xx
Xxxxx
Xxxxxxxx
Xxxxxx Xxxxx
The
Xxxxxx Xxxxxxx Xxxx
Xxxxxx
XX0
0XX
With a
copy sent to:
Amarin
Pharmaceuticals Ireland Limited
1st
Floor, Block 3
The
Oval
Xxxxxxxxxx
Xxxx
Xxxxxxxxxxx
Xxxxxx
0
Xxxxxxx
Payment
Schedule
To be
agreed, inserted
18
SCHEDULE
4: BUDGET BREAKDOWN
The
budget breakdown is detailed below:
Description
|
Unit
Description |
Total
Units |
Unit
Cost |
Budget
Total
(£)
|
|
Grand
Total
|
Expenses –
Estimates
[to
be inserted]
19
APPENDIX
2
CHANGE
ORDER
Amarin
|
|
Amarin
Contact
|
Xxxxxxx
River
|
|
Xxxxxxx
River Contact
|
Amarin
Project Reference:
|
|
MSA
Date:
|
DD
MMM YYYY
|
Work
Order Date:
|
DD
MMM YYYY
|
Date
Change Requested:
|
DD
MMM YYYY
|
Date
to Implement Change:
|
DD
MMM YYYY
|
Original
Contract
Value £
|
|
Change
History
|
Change
Value
|
[insert
details of changes to Project Protocol, budget, timelines, payment
schedule]
|
Amarin
authorizes Xxxxxxx River to begin work
immediately following execution of this Change Order.
Except as
expressly set forth in this Change Order, all other terms and conditions of the
Master Services Agreement remain the same.
For
and on behalf of
Amarin
Neuroscience Ltd
Signature:
Name:
Title:
Date:
|
For
and on behalf of
Xxxxxxx
River Laboratories Preclinical Services Edinburgh Limited
Signature:
Name:
Title:
Date:
|
For
and on behalf of
Amarin
Pharmaceuticals Ireland Limited
Signature:
Name:
Title:
Date:
|
20
APPENDIX
3
Xxxxxxx
River Archive Terms and Conditions
1.
|
All
raw data, study documentation, protocols, interim and final reports,
specimens generated as a result of a preclinical Study or case histories
generated as a result of a clinical Study that the Sponsor
requests be held in Company’s archive facility or that Applicable Law
requires be held in Company’s archive facility shall
hereinafter be referred to as “Materials”. Company agrees to
comply with industry standards in connection with the storage of the
Materials and adhere to all Applicable Law with respect to the storage of
the Materials.
|
2.
|
Company
shall store the Materials at its current storage rates, which may be
increased on an annual basis. If the Materials require
additional and/or special storage requirements, additional charges for
storage shall be assessed and invoiced to Sponsor. Invoices
shall be due and payable ten (10) days from the date of the invoice and
Sponsor agrees to pay all invoices
submitted.
|
3.
|
Company’s
liability for archival services under this Agreement, regardless of the
form of action, shall not exceed the fee paid for one year’s storage of
the Materials. In no event shall Company be liable for
penalties or liquidated damages or for special, indirect, consequential
punitive, exemplary or incidental damages of any type or kind (including,
without limitation, lost profits) in connection with the storage of the
Materials. Company shall have no liability for loss of
specimens or information beyond its reasonable control, including losses
caused by loss of refrigeration.
|
4.
|
The
Materials shall be archived for the period set forth in the Supporting
Documents (the “Retention Period”). Upon the expiration of the
Retention Period, Company shall contact Sponsor to determine disposition
of the Materials as follows: (a) extended storage of the Materials; (b)
return of the Materials to Sponsor at Sponsor’s expense to be archived in
accordance with Applicable Law or (c) disposal of Materials at Sponsor’s
expense. If Sponsor requests Company to continue to store the
Materials and Company agrees, the cost for storage of the Materials shall
continue to be invoiced to Sponsor at Company’s then current
rates. If Sponsor fails to give such instructions, Company
shall so notify Sponsor, and if such instructions are still not
forthcoming within thirty (30) days of said notification, then Company
shall have the option of (i) continuing storage of the Materials, which
will be deemed to have been authorized for an additional period of not
less than one (1) year, or (b) Company may return the Materials to Sponsor
at Sponsor’s expense or (c) dispose of the Materials at Company’s expense
provided regulatory retention periods have expired. Sponsor
shall be liable for storage charges until the Materials are returned to
Sponsor. At any time while the Materials are in transit to
Sponsor, all risk of loss or exposure to the Materials shall be borne by
Sponsor.
|
5.
|
Company
will not release the Materials to any third party, without Sponsor's
written permission unless such disclosure is compelled by valid subpoena
or Applicable Law. If such disclosure is requested, Company
shall use its commercially reasonable efforts to provide Sponsor with
written notice prior to such release. Prior to release or
inspection of any Materials by Sponsor or its agents, Sponsor shall
provide all reasonable documentation requested by
Company.
|
21