MASTER SERVICES AGREEMENT
Exhibit
4.69
| AGREEMENT | Made on the 15 day of November 2006 (“Effective Date”) | |
| BETWEEN | ICON Clinical Research (UK) Limited doing business as ICON Development Solutions (hereinafter called “ICON”) of 0 Xxxxxxxxx, Xxxxxxxxx Xxxxxxxx Xxxx, Xxxxxx, Xxxxx XX0 0XX, XX | |
| AND | Amarin Pharmaceuticals Ireland Limited of 00 Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx 0, Xxxxxxx (hereinafter called (“CLIENT”) |
WHEREAS CLIENT desires to retain ICON to provide, and ICON
wishes to provide consultancy
and/or other
services (“the Services”), to CLIENT from time to time
and subject to the terms and conditions of this Agreement and
for the purposes set out herein and:
WHEREAS the parties to this Agreement wish to agree upon the
various terms and conditions that will govern their business
relationship for the term specified in this Agreement in
connection with the provision of Services by ICON to CLIENT.
THE
PARTIES HERETO AGREE AS
FOLLOWS:
1. (a) ENGAGEMENT —
Subject to the terms and conditions set out in this
Agreement, CLIENT hereby retains the services of ICON, and ICON
hereby agrees to provide services (“the Services”)
from time to time as may be specified in individual Project
Contracts as set out below, in connection with the development
of certain medical/biopharmaceutical products (the
“Products”) as CLIENT requires.
For the avoidance of doubt, this MSA is specific to the
provision of due diligence services by ICON Development
Solutions and is additional to that already in place with Amarin
Corporation plc and, therefore, should in no way be construed as
replacing or superseding that agreement.
(b) SERVICES — The Services
to be provided shall include but shall not be limited to:
(i) Providing due diligence services and reports in respect
of scientific, clinical
and/or
regulatory matters relating to companies
and/or
specified products in the manner requested by CLIENT;
(ii) Such other services as may be required or as may
otherwise be agreed between the parties, relating to the
PRODUCTS.
(c) TERMS &
CONDITIONS
(i) All Services provided by ICON under this agreement
shall be subject to the ICON Plc Group Terms and Conditions as
set out in Appendix A hereto, together with such specific
terms or conditions as may be agreed in writing and specified in
each Project Contract.
Any terms and conditions in Project Contracts which conflict
with any terms and conditions in this Agreement shall only be
valid and enforceable where they are specifically identified in
writing as such in the Project Contract and in that case shall
only be valid and enforceable for that particular Project
Contract. In the absence of any such provision the terms and
conditions of this Agreement shall prevail.
(d) PROJECT CONTRACTS
(i) Each individual project assignment under this Master
Services Agreement will be defined in numbered Project
Contracts. Each Project Contract will be separately negotiated
and executed by the parties and when so executed shall be
incorporated into this Master Services Agreement by reference in
Appendix B to this Master Services Agreement.
(ii) Each Project Contract, together with the terms and
conditions of this Agreement, shall constitute and be construed
as a separate agreement.
(e) AFFILIATES
(i) ICON and CLIENT intend that their respective Affiliates
may also execute Project Contracts. Unless the context requires
otherwise, references to CLIENT or ICON in this Master Agreement
(together with the related rights and obligations) as
incorporated into a Project Contract shall apply to the CLIENT
Affiliate or ICON Affiliate that is a party to the Project
contract.
(ii) For the purposes of this Agreement and any Project
Contracts “Affiliate” shall mean any entity that
controls, is controlled by, or is under the common control with
that party. In this context “control” shall mean
(1) ownership by one entity, directly or indirectly, of at
least fifty percent (50%) of the voting stock of another entity,
(2) power of one entity to direct the management or
policies of another entity by contract or otherwise, or
(3) any other relationship between a party and an entity
which both CLIENT and ICON have agreed in writing may be
considered an “Affiliate” of a party.
| 2. | TERM & TERMINATION |
(i) This Master Services Agreement shall take effect on the
Effective Date and shall continue unless terminated as provided
below.
(ii) Each Project Contract shall take effect and terminate
as designated in the Project Contract. Termination of this
Master Services Agreement or any Project Contract shall not
affect any other Project Contract: each Project Contract shall
continue in force and effect unless specifically terminated in
accordance with the terms of this Master Services Agreement or
the terms of that Project Contract.
(iii) Either party may terminate this Master Services
Agreement
and/or any
Project Contract in the event of a material breach by the other
party. The party seeking to terminate shall provide written
notice to the party in breach setting forth in reasonable detail
the nature of such breach. The breaching party shall have
30 days within which to cure such breach. If the breaching
party fails to cure within such
30-day
period, the party asserting the breach shall have the right to
immediately terminate this Master Services Agreement
and/or the
relevant Project Contract.
(iv) Either party may terminate this Master Services
Agreement
and/or a
Project contract for any reason upon providing 90 days
written notice to the other.
(v) Either party may terminate this Master Services
Agreement
and/or a
Project contract immediately upon written notice if:
a. The other party becomes insolvent, or if proceedings are
instituted against that other party for reorganization or other
relief under any bankruptcy law, or if any substantial part of
the other party’s assets come under the jurisdiction of a
liquidator, receiver or trustee in an insolvency proceeding
authorized by law, or;
b. If there is a change in control of the other party by
the acquisition by any person or entity, directly or indirectly,
of more than fifty percent (50%) of the total voting capital
stock of the other party or by any sale, lease, exchange or
other disposition by that party of all or substantially all of
its assets.
(vi) In the event of early termination of this Master
Services Agreement
and/or a
Project Contract for any reason, the parties agree that:
a. They shall co-operate with one another to ensure the
orderly winding down and transition of the services being
provided and the transfer of all data, materials and information
to the CLIENT thereof, and;
b. CLIENT shall immediately pay to ICON all outstanding
amounts in respect of fees earned and expenses or costs incurred
up to the date of such early termination.
3. COMPENSATION — In
consideration for its provision of services under a Project
Contract, CLIENT shall pay ICON in accordance with the terms and
amounts specified in the Project Contract.
4. GOVERNING LAW —
This Agreement shall be governed by and construed in
accordance with the law in force for the time being in England.
IN WITNESS WHERE OF the parties hereto have
cause this Agreement to be duly executed by their authorised
representatives as of the dates written below.
|
AMARIN PHARMACEUTICALS
IRELAND LIMITED |
ICON CLINICAL RESEARCH (UK) LTD doing business as ICON DEVELOPMENT SOLUTIONS |
|
|
Date: 11/12/06
|
Date: 15/11/06 | |
|
Title: Director
|
Title: Vice President | |
|
SIGNED
XXXXXX XXXXXXXXXX
|
SIGNED S. C. XXXX |
MASTER
SERVICES AGREEMENT- APPENDIX A
ICON
CLINICAL RESEARCH (UK) LTD doing business as ICON
DEVELOPMENT SOLUTIONS TERMS AND CONDITIONS FOR SUPPLY OF SERVICES
DEVELOPMENT SOLUTIONS TERMS AND CONDITIONS FOR SUPPLY OF SERVICES
| 1. | DEFINITIONS |
a. “ICON” shall mean ICON Plc
and/or any
of its subsidiary or associated companies.
b. “CLIENT” shall mean the company, corporation,
person or other legal entity to which Icon supplies services,
which are subject to these Terms & Conditions.
c. “FEES” shall mean collectively all sums due to
ICON from CLIENT in consideration for the supply of services,
together with all due Expenses and Costs.
d. “EXPENSES” shall mean travel and accommodation
expenses as agreed from time to time with CLIENT.
e. “COSTS” shall mean all other charges arising
in connection with the provision of services (other than service
fees and Expenses) including, but not limited to fees payable to
third parties, telecommunication costs, couriers, translation
costs, photocopying and other such costs as are agreed with
CLIENT.
f. “PROPOSAL” shall mean the ICON proposal for
the provision of Services as agreed with CLIENT.
g. “SERVICES” shall mean consultancy or other
such services to be provided by ICON as are agreed with CLIENT
in a Project Contract or otherwise.
h. “PROJECT CONTRACT” shall mean the legally
binding agreement between ICON and CLIENT (whether in writing,
orally or a combination of both), for the provision of Services
by ICON to be subject to these Terms & Conditions.
i “CONFIDENTIAL INFORMATION” shall mean the
information defined in Clause 5 below.
| 2. | SERVICES |
a. ICON shall provide services in good faith and with
reasonable care and skill as agreed with CLIENT.
b. Services shall be provided in accordance with all
generally accepted professional standards and in compliance with
all applicable laws, rules, regulations and Protocols.
c. Any material change to the Services shall be agreed
between ICON and CLIENT and shall be subject to any applicable
amendments in fees, costs and expenses.
d. A Proposal shall only become binding upon ICON if
accepted in writing by CLIENT within 3 months of the date
of the Proposal. If not so accepted, any assumptions or estimate
costs in the Proposal may be subject to change by ICON.
e. In the event that ICON, in good faith and at the written
request of CLIENT, shall provide Services to CLIENT prior to or
in contemplation of the formal execution of a Project Contract
in respect of the provision of any Services, ICON shall be
entitled to a payment by CLIENT in respect of any Services so
provided, notwithstanding that such Project Contract shall not
have been formally executed by ICON
and/or
CLIENT.
f. In the event that CLIENT is responsible for providing
ICON with data, materials or other information which is required
by ICON to provide the Services and that delay materially
adversely affects the provision of the Services, then CLIENT
shall be responsible for ICON’S fees, costs and expenses in
relation thereto
and/or at
CLIENT’S election, the time limit for the provision of the
Services (as set out in an applicable time schedule of a Project
Contract) shall be amended accordingly.
| 3. | PAYMENT |
a. In consideration for the Services provided by ICON to
CLIENT, CLIENT shall pay to ICON fees, expenses and costs as
agreed in accordance with ICON’S Proposal
and/or an
applicable Project Contract or as may otherwise be agreed to by
the parties in writing.
b. Unless otherwise agreed, fees, expenses and costs shall
be paid by monthly payments in arrears against an invoice from
ICON describing the Services provided in the preceding month and
consistent with a payment schedule agreed to by the parties in
the applicable Project Contract.
c. Invoices shall be paid by CLIENT within 30 days of
receipt of invoice. Interest may be charged at the rate of
1% per month or part thereof on any invoices overdue for
payment longer than 30 days after receipt by CLIENT.
d. If the provision of services is terminated before the
contemplated completion date for any reason (except ICON’S
fault, insolvency or bankruptcy) then ICON shall be entitled to
payment of all fees and expenses outstanding in respect of
Services provided up to the date of early termination, together
with any reasonable costs necessarily incurred by ICON to
complete its obligations in performing Services.
e. If applicable, VAT
and/or any
other chargeable taxes shall be charged to each invoiced amount
at the appropriate rate and shall be payable by CLIENT.
f. Fees charged to CLIENT by ICON shall not, under any
circumstances, exceed the total amount set forth in the Project
Contract
and/or
Proposal unless the parties shall agree to such an increase in a
written amendment to the Project Contract
and/or
Proposal in advance of any additional fees being incurred.
| 4. | LIABILITY & INDEMNITY |
a. ICON shall not be liable for any loss, damage, claim,
investigations or costs suffered or incurred by CLIENT or any
third party resulting directly or indirectly from the provision
of Services unless and to the extent that, such loss is due to
ICON’S negligence, wilful misconduct or breach of its
obligations in the provision of Services.
b. CLIENT shall indemnify ICON, its servants or agents,
against any claims by third parties alleging loss of or damage
to any property or for the death or injury to any person arising
directly or indirectly from the supply or use of any product or
compound supplied by CLIENT and which is the subject of the
provision of Services unless and to the extent that there is any
negligence, wilful misconduct, breach of obligations on the part
of ICON or its servants or agents in the provision of Services
to CLIENT.
c. ICON shall indemnify CLIENT, its servants or agents
against any claims by third parties alleging loss of or damage
to any property or for the death or injury to any person arising
directly or indirectly due to ICON’S negligence, wilful
misconduct or breath of its obligations in the provision of
Services unless and to the extent that such a loss is due to
CLIENT’S negligence or wilful misconduct.
| 5. | CONFIDENTIALITY |
a. ICON acknowledges that during the course of providing
Services to CLIENT, ICON
and/or its
servants or agents may be exposed to material and other
information, which are confidential to CLIENT
(“Confidential information” as defined herein). ICON,
either by itself or through any of its servants or agents shall
not use, disclose, publicize, disseminate, promote or advertise
any Confidential Information for any purpose other than for the
performance of Services for CLIENT, other than with the prior
written consent of CLIENT, or as may be required by law, in
which case ICON shall give CLIENT as much advance notice of the
proposed disclosure as is practical (including a copy of any
written request or order), and shall co-operate with CLIENT in
any effort to limit or restrict such disclosure, via a
protective order or otherwise.
b. ICON acknowledges that all Confidential Information is
the exclusive property of CLIENT and that ICON has no ownership
or property right in such Confidential Information. Upon request
by CLIENT, either during or after the provision of any Services,
ICON shall return to CLIENT all Confidential Information in
whatever form.
c. “Confidential information” (which shall
include “Inventions”), shall mean any information, in
whatever form of a secret or private nature connected with the
business of CLIENT or any of its suppliers or customers
including, but not limited to, matters of a technical nature
(such as; inventions, products, compositions, formulations,
improvements, methods, know-how, designs, formulae, methods,
developmental or experimental work, clinical data, improvements,
discoveries, pending or potential patent claims, computer
programs and research projects and any information derived there
from), matters of a commercial nature (such as; unpublished
financial information, pricing and costing information, profits,
budgets, promotional methods, marketing sales, customers,
suppliers and employees), business plans and any other
information of a similar nature not ordinarily available
publicly.
d. “Confidential information” shall not include;
(i) Information which is or becomes generally available to
the public otherwise than by reason of a breach of these Terms
and Conditions; or
(ii) Information already in possession of ICON and is at
its free disposal at the time of disclosure by CLIENT; or
(iii) Information received by ICON from a third party under
no obligation of confidentiality to CLIENT; or
(iv) Information which was independently developed by ICON,
as evidenced by written records; or
(v) Information expressly identified in writing by CLIENT
as not being confidential.
e. Any inventions or discoveries (whether or not
patentable), innovations, suggestions, ideas and reports
(“Inventions”), made or developed by either ICON or
CLIENT as a result of performing Services shall be promptly
disclosed to CLIENT and shall be the sole property of CLIENT.
f. Upon CLIENT’S request and at CLIENT’S cost,
ICON will co-operate with CLIENT in obtaining patent or other
proprietary protection concerning any Confidential Information.
| 6. | FORCE MAJEURE |
a. If the performance of any obligation under these
Terms & Conditions,
and/or a
Project Contract by either ICON or CLIENT is prevented,
restricted or interfered with as a result of a Force Majeure,
which shall mean causes beyond either ICON’S or
CLIENT’S reasonable control, being acts of God, fires,
strikes, acts of war, acts of terrorism, or intervention of a
Governmental Authority,, that party shall, upon giving prompt
notice to the other, be excused from performance to the extent
of the prevention, restriction or interference but that party
shall use its best efforts to avoid or remove such causes of
non-performance and shall continue performance under the
Terms & Conditions
and/or
Project Contract with the utmost speed whenever such causes are
removed or diminished. In the event that a performance delay
contemplated hereunder exceeds 30 days, the non-delaying
party may immediately terminate the applicable Project Contract.
| 7. | GENERAL |
a. Unless otherwise agreed in writing, these
Terms & Conditions govern the supply of all Services by
ICON to any CLIENT and ICON does not accept to any oral or
written terms or conditions submitted by CLIENT unless ICON
expressly agree in writing to accept a variation of these
Terms & Conditions.
b. ICON shall not assign any of its rights or obligations
under any Contract without the prior written consent of CLIENT.
c. No modification of these Terms & Conditions
shall be deemed effective unless in writing and signed by both
ICON and CLIENT and no waiver of any right herein shall be
deemed effective unless in writing and signed by the party
against whom the waiver is sought.
d. If any of the provisions of these Terms &
Conditions is held to be unenforceable or invalid by a court of
competent jurisdiction, the validity and enforceability of the
enforceable portion of any such provision
and/or the
remaining provisions shall not be affected thereby.
e. These Terms & Conditions and any Contract which
is subject to them shall be governed and construed in accordance
with the laws of England.
Client Xxxxxx Xxxxxxxxxx
Date 23/11/06
MASTER
SERVICES AGREEMENT-APPENDIX B
LIST OF PROJECT CONTRACTS UNDER MASTER SERVICES AGREEMENT
LIST OF PROJECT CONTRACTS UNDER MASTER SERVICES AGREEMENT
1. PROJECT
CONTRACT NO. 7076
1.
PROJECT CONTRACT NO. 7076
| PARTIES | ICON CLINICAL RESEARCH (UK) LTD doing business as ICON Development Solutions (“ICON”) with offices located at 2 Globeside, Xxxxxxxxx Xxxxxxxx Xxxx, Xxxxxx, Xxxxxxxxxxxxxxx, XX0 0XX and Amarin Pharmaceuticals Ireland Limited of 00 Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx 0, Xxxxxxx (hereinafter called “CLIENT”) | |
| DATE | EFFECTIVE DATE: 13 November 2006 | |
| TERMS |
1. ICON agrees to supply to CLIENT the Services
specified below at the Fees specified, subject to:
|
|
|
a. The Master Services
Agreement (“MSA”) dated [ ] November 2006
(“MSA”) and specifically the Terms &
Conditions of Appendix A of that Agreement.
|
||
|
b. This Project
Contract.
|
||
|
2. This Project Contract and the Terms &
Conditions of the MSA shall upon acceptance by CLIENT
collectively comprise the Contract between ICON and CLIENT for
the provision of the Services.
|
||
|
3. ICON supplies the Services as an independent
contractor and no relationship of employer or employee shall
arise or be created under this Project Contract as and between
CLIENT and ICON
and/or any
personnel engaged by ICON to provide the Services.
|
||
| This Project Contract shall not become binding and ICON shall not be obliged to provide any Services until acceptance in writing of this Project Contract is received. | ||
| SERVICES | Due diligence activities with respect to in-licensing opportunities for compounds with therapeutic potential in CNS disorders as instructed by Amarin | |
| TIME SCHEDULE | • Project Start (Est): November 2006 | |
| • Project Completion (Est): December 2007 | ||
| FEES | Estimated costs for due diligence activities with respect to in-licensing opportunities for compounds with therapeutic potential in CNS disorders shall be as set forth in Appendix A to this Project Contract. The amount will not exceed £10,000 without prior consultation with Amarin. | |
| Costs shall include all consulting fees and secretarial/administrative staff costs, but exclude other direct costs such as translations, purchase of publications, photocopying and binding, couriers, fees of regulatory agencies, travelling and accommodation expenses, and other disbursements to third parties as may be agreed with CLIENT from time to time. | ||
| Unless otherwise specified, this estimate does not include the cost of time spent by ICON staff in meetings, video or teleconferences with CLIENT, CLIENT’s experts or other third parties as required by CLIENT from time to time. Such meetings will be charged at the applicable hourly rate per person. | ||
| This estimate is based on data unseen and historical experience of projects of this nature; ICON reserves the right to review these costs |
| when xxxxxx information is made available. Any changes in the scope of the project will be documented and agreed by both parties. | ||
| This estimate is valid for three months from the date indicated on the cover. ICON reserves the right to review these costings, if the proposal is not accepted within this period. | ||
| Consulting fees for the year to 31 May 2007 are listed in Appendix I to the Project Contract; ICON reserves the right to increase these fees on 1st June 2007. | ||
| PAYMENT SCHEDULE | Invoices will be issued monthly itemising the hours worked | |
| NOTICES | Notices relating to this Project Contract shall be delivered and addressed as follows: |
|
If to CLIENT:
|
Contact Title | Xxxxxx Xxxxxxxxxx | ||
| Client Name | Amarin Pharmaceuticals Ireland Limited | |||
| Client Address |
00 Xxxxxxxx Xxxx Xxxxxxxxxxx Xxxxxx 0 Xxxxxxx |
|||
| Phone: | x000 (0)0 0000 000 | |||
| Fax: | x000 (0)0 0000 000 | |||
| E-mail: | Xxxxxx.Xxxxxxxxxx@xxxxxxxxxx.xxx | |||
|
If to ICON:
|
Contact | Xxxxxx Xxxx | ||
| Title | VP Global Regulatory Affairs | |||
|
Name Address |
ICON Development Solutions 0 Xxxxxxxxx Xxxxxxxxx Xxxxxxxx Xxxx XXXXXX Xxxxxxxxxxxxxxx XX0 0XX |
|||
| Phone: | 00000 000000 | |||
| Fax: | 00000 000000 | |||
| E-mail: | xxxxx@xxxxxx.xxx | |||
|
With copy to:
|
Contact | Xxxxx Xxxxx | ||
| Title | Director, Business Development | |||
| Name | ICON Development Solutions | |||
| Address |
2 Globeside Xxxxxxxxx Xxxxxxxx Xxxx XXXXXX Xxxxxxxxxxxxxxx XX0 0XX |
|||
| Phone: | 00000 000000 | |||
| Fax: | 00000 000000 | |||
| E-mail: | xxxxxxx@xxxxxx.xxx |
| INVOICES and PAYMENTS | All ICON invoices should be forwarded to CLIENT as follows: | |
| Xxxxxx Xxxxxxxxxx | ||
| Amarin Pharmaceuticals Ireland Limited 00 Xxxxxxxx Xxxx | ||
| Xxxxxxxxxxx | ||
| Xxxxxx 0 | ||
| Xxxxxxx | ||
| All payments shall be in electronic form, payable to ICON Clinical Research (UK) Limited at: |
|
Bank:
|
Barclays Bank, Xxxxx Xxxxxx, Xxxxxxxxxx, XX00 0XX | |||
|
Account:
|
ICON Clinical Research (UK) | |||
|
Account No.:
|
00000000 | |||
|
Sort Code:
|
20 97 01 | |||
|
Swift Code:
|
XXXXXX000XX | |||
|
IBAN No:
|
IBAN XX00 XXXX 0000 0000 0000 00 | |||
|
AMARIN PHARMACEUTICALS
IRELAND |
ICON CLINICAL RESEARCH (UK)
LTD |
|
|
LIMITED |
doing business as ICON DEVELOPMENT SOLUTIONS | |
|
Date: 13 November 2006
|
Date: 15/11/06 | |
|
Name: Xxxxxx Xxxxxxxxxx
|
Name: S. C. Xxxx | |
|
Title: Director
|
Title: Vice President | |
|
SIGNED
|
SIGNED |
PROJECT
CONTRACT NO. 7076 — APPENDIX A
ICON
DEVELOPMENT SOLUTIONS — CONSULTING FEES
Hourly
Rates to
1st June
2007
|
Project Assistant
|
£51 | |
|
Publisher
|
£78 | |
|
Documentum &
E-Submissions
Manager
|
£147 | |
|
Regulatory Associate
|
£74 | |
|
Regulatory Consultant
|
£125 | |
|
Senior Consultant
|
£147 | |
|
Principal Consultant
|
£170 | |
|
Senior Director / Expert
|
£191-216 |
