CONSULTANCY AGREEMENT
Exhibit 4.85
THIS AGREEMENT is made as of
the date of last signature hereof (the “Effective Date”) BETWEEN:
(1)
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Amarin Corporation plc
whose place of business is First Floor, Block 3, the Oval, Xxxxxxxxxx
Xxxx, Xxxxxxxxxxx, Xxxxxx 0 (“Amarin”)
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(2)
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ICON Clinical Research
Limited whose registered office is at Xxxxx Xxxxxx Xxxxxxxx Xxxx,
Xxxxxxxxxxxx, Xxxxxx 00 (“ICON”).
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RECITALS
(A)
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Whereas
Amarin is running a project entitled EN101 Phase IIa (the “Project”).
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(B)
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Whereas
Amarin requires a consultant with a certain skill set to assist in the
performance of the Project.
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(C)
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Whereas
ICON has personnel which have such a skill
set.
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1.
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CONSULTANCY
SERVICES
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1.1
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ICON
will provide and Amarin accepts Xxxxxxxxx Xxxxxxx, as Project Manager (the
“Consultant”), who will be assigned to the Project, with support provided
as necessary by ICON personnel Xxxxxxxxx Xxxxx and Xxxxxxx Xxxxx (the
“Additional Personnel”). The Consultant will be located either Amarin’s
premises at First Floor, Block 3, the Oval, Xxxxxxxxxx Xxxx, Xxxxxxxxxxx,
Xxxxxx 0 or ICON’s premises at Xxxxx Xxxxxx Xxxxxxxx Xxxx, Xxxxxxxxxxxx,
Xxxxxx 00 (the “Premises”) as determined
by Amarin from time to time subject to the terms and conditions set out
below.
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2.
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DURATION
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2.1
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ICON
commenced the provision of the Services (as such term is defined below in
Clause 3.1) on 1st
of August 2008.
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2.2
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The
term of this Agreement shall commence on the Effective Date and shall
continue until 31st
of January 2009 unless terminated earlier in accordance with section 7 or
the term may be extended further upon written agreement by both parties
(the “Term”).
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2.3
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The
terms of this Agreement shall be deemed to apply to any Services provided
to Amarin prior to the Effective
Date.
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3.
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CONSULTANT
SERVICES
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3.1
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For
the period of the Term the Consultant is retained by Amarin on a part-time
basis to provide the project management services specified in the Schedule
attached hereto (the “Services”) to Amarin
during normal business hours for up to thirty two hours during each week
of this
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Agreement
at the Premises. The number of hours per week may be increased during
the term of the agreement subject to agreement by both parties. It is
acknowledged that the Consultant may be required to travel, on occasion, for
business purposes. Any such travel shall be conducted by the
Consultant in accordance with the Amarin Travel Policy (as may be amended from
time to time).
3.2
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ICON
agrees that the Consultant shall use her best commercial efforts to ensure
that tasks marked 1 to 3 inclusive in the Schedule (Appendix I) are
completed by the 31st
of August 2008. Provided however neither ICON nor the
Consultant shall be responsible for a failure to meet its obligations or
timelines under this Agreement to the extent caused by the following: (i)
materially inaccurate data; (ii) any failure by Amarin to meet its
obligations stated in this Agreement; (iii) any failure of equipment,
facilities or services not controlled or supplied by ICON; (iv) failure to
timely receive required data, documents, materials or information; or (v)
lack of availability or access to relevant Amarin or other third party
personnel.
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3.3
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ICON
shall, and shall procure that the Consultant and the Additional Personnel
shall, perform the Services in good faith, with reasonable care and skill,
in accordance with the terms of this Agreement and all applicable laws
regulations and guidelines, and in accordance with the reasonable
instructions of Amarin.
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3.4
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In
the event that the Consultant becomes for any reason unable to perform the
Services for a period in excess of 14 days, ICON will promptly notify
Amarin of that fact, the reason for and the likely duration of such
inability, and if the Consultant is unable for any reason to perform the
Services for a period in excess of 14 days during this Agreement, Amarin
will be entitled to treat this Agreement as frustrated and accordingly
terminated with immediate effect without compensation other than the
payment of Fees and expenses in accordance with the terms of this
Agreement.
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3.5
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In
the event that ICON and Amarin agree that the Consultant will require
additional third party resources in order to provide the Services, ICON
shall agree in advance in writing with
Amarin:
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3.5.1
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the
nature and identity of the third party resources that are
required;
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3.5.2
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the
fees payable to such third party
resources.
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Any such
services shall be provided directly to Amarin by such third
parties.
4.
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AMARIN’S
OBLIGATIONS
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4.1
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Amarin
shall at the start of the Project provide to Consultant, an appropriate
orientation of the Project.
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2
4.2
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Amarin
will assist and support the Consultant to ensure that she obtains all the
necessary information and access to the required
personnel.
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4.3
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During
the term of this Agreement, and for one year thereafter, (the “Restricted Period”),
Amarin agrees not to solicit directly or indirectly, the Consultant for
employment with Amarin whether as an employee, independent contractor or
otherwise. If Amarin breaches this provision, it agrees to pay
ICON one year of the Consultant’s salary, to be calculated as the base
salary at the time of the Consultant’s departure from ICON, plus any
bonuses and incentive paid within the 12 months prior to the Consultant’s
termination of employment from ICON, but in no event less than one year’s
salary.
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5. FEE
5.1
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ICON
shall, in respect of the services set out in the Schedule be paid the sum
of:
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–
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€163
per hour or part thereof for Xxxxxxxxx Xxxxxxx – Clinical Project
Manager
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–
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€193
per hour or part thereof for Xxxxxxx Xxxxx – Associate Director Clinical
Operations
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–
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€240
per hour or part thereof for Xxxxxxxxx Xxxxx – VP Corporate
QA
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(such
fees to be exclusive of value added tax if applicable) payable monthly in
arrears on a time and cost basis. ICON shall submit a monthly invoice
to Amarin detailing the hours worked and amount due in accordance with this
Agreement.
6.
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EXPENSES
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6.1
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Amarin
shall reimburse ICON/Consultant for all out of pocket expenses reasonably
incurred by her in the proper provision of her services for the Project
hereunder to include but not limited to travel costs, petrol and
subsistence expenses provided that on request the Consultant shall provide
Amarin with such vouchers or other evidence of actual payment of such
expenses as Amarin may reasonably
require.
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Amarin
will reimburse ICON/Consultant for reimbursable expenses within thirty (30) days
of receipt of ICON/Consultant’s invoice.
7.
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TERMINATION
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7.1
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Without
limitation either party may by notice in writing immediately terminate
this Agreement if the other party shall be in breach of any of the terms
of this Agreement which, in the case of a breach capable of remedy, shall
not have been remedied by the defaulting party within 21 days of receipt
by the defaulting party of a notice from the other party specifying the
breach and requiring its remedy;
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7.2
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Amarin may
by notice in writing immediately terminate this Agreement if the
Consultant shall:
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3
7.2.1
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be
guilty of gross misconduct and/or any serious or persistent negligence in
the provision of her services
hereunder;
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7.2.2
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fail
or refuse after written instruction to provide the services reasonably and
properly required of her hereunder;
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7.2.3
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conduct
herself in any manner which, in the reasonable opinion of Amarin, brings
or is likely to bring Amarin into disrepute by
association.
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7.3
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With
effect from two months after the Effective Date, Amarin may terminate this
Agreement on 30 days notice in writing to
Consultant.
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8.
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CONFIDENTIAL
INFORMATION
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8.1
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During
the term of this Agreement and for a period of 7 (seven) years thereafter,
each of the parties (each a “Recipient”) undertakes
to maintain as confidential all information, data and materials, and
intellectual property disclosed to it by the other party (the “Disclosing Party”) on
or prior to the date of this Agreement (“Confidential
Information”).
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8.2
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“Affiliates” shall mean,
in respect of each party, a corporation or entity controlling, controlled
by, or under the common control with such party. 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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8.3
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Confidential
Information shall not, without the Disclosing Party’s prior written
consent, be used by the Recipient (or permitted by it to be used by any
person) for any purpose other than the proper performance of its
obligations under this Agreement.
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8.4
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Each
Recipient shall not, without the Disclosing Party’s prior written consent,
disclose Confidential Information of the Disclosing Party to any other
person, save as may be strictly necessary in order to perform the
Services, and provided that the Recipient first ensures that such third
party is under a duty of confidentiality to the Recipient to protect the
confidentiality of the Confidential Information on no less onerous terms
than as set out in this Clause 8.
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8.5
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The
obligations of confidentiality set out in this Clause shall not apply to
any Confidential Information which:
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8.5.1
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came
lawfully into the Recipient’s possession prior to the date of
disclosure;
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8.5.2
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is
or becomes public knowledge through no fault or omission of the
Recipient;
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4
8.5.3
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is
required to be disclosed by law, in which case the Recipient shall give
the Disclosing Party as much advance notice of the proposed disclosure as
is practical (including a copy of any written request or order), and shall
cooperate with the Disclosing Party in any effort to limit or restrict
such disclosure, via a protective order or
otherwise;
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8.5.4
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is
furnished or made known to the Recipient by a third party otherwise than
in breach of any obligation of confidentiality to the Disclosing
Party;
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8.5.5
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is
independently developed by the Recipient without access to the
Confidential Information, as evidenced in writing by the
Recipient.
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8.6
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Each
party agrees to maintain as strictly confidential the subject matter of
this Agreement and the fact that the parties have entered into this
Agreement and ICON agrees not to make any public announcement or publish
in any manner whatsoever any information relating thereto, without the
prior written consent of Amarin.
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8.7
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Neither
party makes any representation or warranty as to the accuracy or
completeness of its Confidential
Information.
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8.8
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Save
for the right to use Confidential Information for the sole purpose of
performing its obligations under this Agreement, each party agrees that
Confidential Information is and shall remain the sole property of the
Disclosing Party and that nothing in this Agreement shall be understood as
granting, expressly or by implication, any rights to the Recipient under
any Confidential Information.
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8.9
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Upon
termination or expiration of this Agreement, each party shall promptly
return, or at the other party’s request destroy, all Confidential
Information of such other party.
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9.
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OWNERSHIP
OF DATA AND INTELLECTUAL PROPERTY
RIGHTS
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9.1
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This
Clause 9 applies to any Data and Intellectual Property conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder by ICON, its servants or agents, including without
limitation the Consultant and the Additional
Personnel.
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9.2
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ICON
agrees that all data, materials and reports (“Data”) conceived,
discovered, developed, made, produced or created as a result of performing
the Services hereunder and all rights therein shall be solely owned by
Amarin.
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9.3
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ICON
agrees that any patent right, invention, registered design, copyright,
database right, design right, trade xxxx, service xxxx, application to
register any of the aforementioned rights, trade secret
or
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5
rights
(including rights of confidentiality) in know-how (“Intellectual Property”)
conceived, discovered, developed, made, produced or created as a result of
performing the Services hereunder and all rights therein, shall be owned
exclusively by Amarin.
9.4
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ICON
hereby assigns to Amarin by way of future assignment of copyright the
copyright subsisting in the copyright works and in the documents generated
by the Consultant during the course of, or otherwise related to, the
provision of the Services.
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9.5
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The
Consultant agrees to promptly disclose to Amarin any Data and Intellectual
Property conceived, developed, produced, or created as a result of
performing the Services hereunder and to provide copies of all documents
relating to same to Amarin at its request at any time whether during or
after expiry or the termination for any reason of this
Agreement.
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9.6
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Notwithstanding
the foregoing, any Intellectual Property and Data which have been
independently developed or improved during the term of this Agreement by
ICON or the Consultant without use of the Amarin Confidential Information
and which relate solely to ICON’s business or operations shall remain the
sole and exclusive property of ICON and Amarin shall hold same
in strictest confidence.
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10
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REPRESENTATIONS,
WARRANTIES AND INDEMNIFICATION
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10.1
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ICON
represents and warrants to Amarin
that:
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10.1.1
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the
performance of ICON’S obligations hereunder are not inconsistent with
and/or will not breach any third party obligations whether express or
implied;
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10.1.2
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the
Consultant and the Additional Personnel are sufficiently competent and has
appropriate professional skills and qualifications in order to perform the
Services; and
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10.1.3
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ICON
has agreements in place with all servants and agents, including without
limitation the Consultant and the Additional Personnel, that impose
confidentiality obligations on such servants and agents, effectively vest
in ICON any rights such servants and agents might otherwise have in any
Intellectual Property, permit ICON to assign all such rights to Amarin,
and otherwise enable ICON to comply with the terms of this
Agreement.
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10.2
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As
the Consultant will be the responsibility of and under the direct control
and supervision of Amarin during the Term, Amarin hereby agrees
to defend, indemnify, and hold harmless ICON and its respective employees
and agents (collectively referred to as “ICON Indemnitees”) against and
from any claims, proceedings, or actions brought by
Consultant or third parties against an ICON Indemnitee arising out
of the performance of the Services pursuant to this Agreement (in
particular but
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6
not
limited to arising out of any discriminatory conduct towards the Consultant by
Amarin or any of its employees and agents or invitees to its premises),
including without limitation, amounts paid in settlement of claims, proceedings,
or investigations and agrees to bear all costs and expenses, including without
limitation, reasonable attorney's fees incurred in connection with the defense
or settlement of any such claim, proceeding or investigation as such costs and
expenses are incurred in advance of judgment (“Claim”). Notwithstanding
the foregoing, Amarin’ indemnification obligation pursuant to this paragraph
shall not apply to the extent that any such claim, proceeding or action arises
from:
10.2.1
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the
negligence or wilful misconduct of Consultant, the Additional Personnel or
ICON in the performance of its obligations under this Agreement;
or
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10.2.2
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any
breach of any representation, warranty, obligation or covenant of ICON
under this Agreement.
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10.3
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ICON
shall indemnify Amarin and its respective employees and agents
(collectively referred to as “Amarin Indemnitees”) against and from any
Claims brought against an Amarin Indemnitee, to the extent that any such
claim, proceeding or action arises
from:
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10.3.1
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the
negligence or wilful misconduct of Consultant, the Additional Personnel or
ICON in the performance of their obligations under this Agreement;
or
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10.3.2
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any
breach of any representation, warranty, obligation or covenant of ICON
under this Agreement
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10.4
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The
party seeking an indemnity shall:
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10.4.1
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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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10.4.2
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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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10.4.3
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co-operate
in the investigation and defence of such claim or proceedings;
and
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10.4.4
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take
all reasonable steps to mitigate any loss or liability in respect of any
such claim or proceedings.
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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.
7
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10.5
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The
parties shall at their own expense obtain and maintain insurance of a type
and amount adequate to cover all loss, damage, liability or costs in
respect of which they are liable to indemnify the other under the
provisions of this Agreement and shall not do or omit any act, matter or
thing which may prejudice or render voidable any such
insurance. Each party will, upon the request of the other,
provide such other party with evidence of the insurance as such other
party may reasonably require
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11. LIMITATION OF
LIABILITY
11.1
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ICON
accepts no responsibility for any supplies and/or equipment supplied by
Amarin to the Consultant for use during the work covered by this
Agreement, provided that such supplies and/or equipment, is not damaged by
the negligence or wilful misconduct of
Consultant.
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11.2
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Neither
party shall be liable to the other for loss, damage, or liability in
respect of loss of profits, business or revenue loss, special, indirect or
consequential loss (even if foreseeable or in the contemplation of either
party).
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12
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NOTICE
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12.1
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Any
notice required by this Agreement to be given by either party to the other
shall be in writing and shall be served by sending the same by electronic
mail, registered post or recorded delivery to the last known address of
the other party and any receipt issued by the postal authorities shall be
conclusive evidence of the fact and date of posting of any such
notice.
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13
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ENTIRE
AGREEMENT
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13.1
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This
Agreement sets out the entire agreement of the parties and supersedes all
prior agreements and understandings relating to its subject
matter.
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14. APPLICABLE
LAW
14.1
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This
Agreement shall be construed by and enforced in accordance with the laws
of the Republic of Ireland and shall be subject to the exclusive
jurisdiction of the Irish courts.
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15.
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INDEPENDENT
CONTRACTOR
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15.1
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In
the performances of all services here under, ICON, Consultant and
Additional Personnel shall be deemed independent contractors as such and
the parties agree that Consultant and Additional
Personnel are not, and will not become, employees of Amarin and
shall not be entitled to any benefits applicable to an employee of
Amarin.
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15.2
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Neither
party is authorized or empowered to act as an agent for the
other for any purpose and shall not on behalf of the other enter into any
contract, warranty or representation as to any matter. Neither
party shall be bound by the acts or conduct of the
other.
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8
15.3
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The
Parties agree that ICON shall be responsible for all payments to the
Consultant and the Additional Personnel for their services to ICON for the
purposes of this Agreement.
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15.4
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ICON
shall be solely responsible for paying when due all income tax, pay
related social insurance, or similar contributions in respect of any
payments to the Consultant and the Additional Personnel arising in
connection with the provision of the Services hereunder, or otherwise
under this Agreement.
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15.5
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Should
Amarin be required to pay any such tax or payment, ICON shall indemnify
Amarin against (and promptly reimburse it for) such tax or payments,
including any interest and penalties with respect
thereto. Should it be determined that any payment hereunder is
subject to withholding of tax under applicable law, all payments to be
made hereunder shall be net of applicable income, employment, social
security or other taxes required to be withheld
therefrom.
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15.6
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The
indemnity contained in this clause 15 shall remain in full force and
effect notwithstanding termination of this Agreement by either party in
any manner whatsoever.
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15.
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SEVERABILITY
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15.1
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The
invalidity or unenforceability of any term or provision of this Agreement
shall not affect the validity or enforceability of any other term or
provision hereof.
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16. WAIVER
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16.1
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No
waiver of any term, provision or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition, or of any other term, provision or condition of this
Agreement.
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17.
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FORCE
MAJEURE
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17.1
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Neither
ICON nor Amarin shall be liable for any failure to perform as required by
this Agreement, to the extent that such failure to perform is caused due
to circumstances reasonably beyond either party's control, such as labour
disturbances or disputes of any kind, accidents, failure of any
governmental approval required for full performance, civil disorders or
commotions, acts of aggression, acts of God, energy or other conservation
measure, explosions, failure of utilities, mechanical breakdowns, material
shortages, disease, or other such
occurrence.
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18. MISCELLANEOUS
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18.1
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No
variation to the terms of this Agreement shall be effective unless in
writing and signed on behalf of each party by an authorised
person.
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18.2
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ICON
may not assign, transfer or sub-contract all or any of its rights and
obligations under this
Agreement.
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9
18.3
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The
Schedules to this Agreement form part of, and shall be deemed to be
incorporated into, this Agreement.
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18.4
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At
the request of either party, the other party 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.
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18.5
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The
provisions of Clauses 4.3, 8, 9, 10, 11, 14, 15, 18.4 and 18.5 shall
survive the termination for any reason of this
Agreement.
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IN WITNESS WHEREOF
the parties hereto have caused this Agreement to be duly executed by
their authorised representatives as of the dates written below.
AMARIN
CORPORATION PLC
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ICON
CLINICAL RESEARCH LIMITED
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Signed______________________
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Signed______________________
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Title________________________
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Title________________________
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Date________________________
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Date________________________
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10
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APPENDIX
I
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SCHEDULE
OF SERVICES
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TASKS
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1.
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Oversee
the completion of study data analysis being managed by
Quanticate,
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a.
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including
working with appropriate Amarin personnel to agree on the ‘per protocol’
group and ‘intent to treat group’ from which the analysis can be
run
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b.
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ensure
any data queries raised by Quanticate are addressed as quickly as
possible, in conjunction with Ester
personnel
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2.
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Understand
the extent to which plasma samples were taken (facilitating measurement of
AChE-R) from patients and overseeing the process to have the data
analyzed, where possible.
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3.
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Oversee
the process of addressing the issues raised by the Adamas audit on the
study, in conjunction with Ester
personnel.
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4.
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Oversee
the completion of a top line EN101 Phase IIa study
report.
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5.
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Oversee
the process of handling further correspondence with the MHRA, following
the notification of breach.
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6.
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Oversee
the completion and interpretation of any other audits being conducted
(IMP, site visits).
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7.
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Resolving
need for reporting breach to authorities in Israel and Serbia and managing
that process.
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8.
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Other
tasks as the parties may agree in
writing
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11