Exhibit 4.5
EXECUTION COPY
DATE: 27TH JANUARY 2003
AMARIN CORPORATION PLC.
AND
ELAN PHARMA INTERNATIONAL LIMITED
DEED OF VARIATION
RELATING TO
OPTION AGREEMENT DATED 18 JUNE 2001
(ZELAPAR(R))
INDEX
1. DEFINITIONS AND INTERPRETATION...................................1
2. INTRODUCTION.....................................................1
3. VARIATIONS.......................................................1
4. CONFIRMATION OF THE AGREEMENT....................................4
5. EXECUTION AND DELIVERY...........................................4
6. MISCELLANEOUS....................................................4
THIS DEED OF VARIATION is made the 27th January 2003
BETWEEN:
(1) AMARIN CORPORATION PLC, a company incorporated in England and Wales
(registered no. 002353920), whose registered office is 0 Xxxxxx
Xxxxxx, Xxxxxx, X0X 0XX Xxxxxxx ("AMARIN"); and
(2) ELAN PHARMA INTERNATIONAL LIMITED, a company incorporated in the Republic
of Ireland, whose registered office is at WIL House, Xxxxxxx Business
Xxxx, Xxxxxxx, Co Clare, Ireland ("ELAN").
WHEREAS:
(A) Amarin and Elan entered into an Option Agreement dated 18 June 2001
(the "AGREEMENT").
(B) Elan Corporation, plc., Elan, Elan International Services Limited, Elan
Pharmaceuticals, Inc., Monksland Holdings BV and Amarin have entered into
a Master Agreement of even date herewith (the "MASTER AGREEMENT").
(C) Pursuant to the Master Agreement, Amarin and Elan have agreed to amend the
Agreement by and upon the terms of this Deed.
NOW THIS DEED WITNESSES AS FOLLOWS:
1. DEFINITIONS AND INTERPRETATION
1.1. Unless the context otherwise requires, all other words and expressions
defined in the Agreement shall have the same meaning in this Deed.
1.2. Reference to clauses herein are to clauses in the Agreement.
2. INTRODUCTION
This Deed is supplemental to the Agreement.
3. VARIATIONS
The parties to this Deed agree that with effect from the date hereof the
Agreement shall be varied as follows:
3.1. Section 3.1(d) shall be deleted in its entirety and replaced with
the following:
"(d) Among other things, the Assignment Agreement shall provide that
Amarin shall assume and perform Elan's obligations under the Xxxxxxx
Agreement as of the date of the transfer and assignment of the Rights;
that in the event of a conflict between the Xxxxxxx Agreement and the
Assignment Agreement, the Xxxxxxx Agreement shall control; that the
parties shall cooperate reasonably to enable the other to fulfill their
respective remaining obligations under the Xxxxxxx Agreement in and
outside the Territory; and that in the event of a material breach by
Amarin of the Assignment Agreement or of this Agreement (including
without limitation failure to pay the sum referred to in Section
7.1(a)(ii) or any milestone payment), or of any other agreement between
Amarin and Elan or any Elan Affiliate, which is not remedied within 90
(ninety) days of Elan giving written notice to Amarin of such breach, or
in the event of the insolvency of Amarin, the Rights shall revert to
Elan. For the purposes of this Agreement, "Elan Affiliate" means Elan
Corporation, plc.
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and each of its subsidiaries, within the meaning of Section 736 of the
Companies Xxx 0000 (UK)."
3.2. Section 3.2 shall be varied by the insertion of the words "the Approval
Date, the "Approval Date" being" immediately after the words "... thirty
(30) days from".
3.3. Section 3.4 shall be varied by the insertion of the words "subject
to Section 4.4" between the words "During the Option Period, Elan
shall" and "be responsible for and...".
3.4. Section 4.4 shall be deleted in its entirety and replaced with the
following:
"4.4 Expenses. The costs and expenses associated with the parties'
respective performance of their obligations under this Agreement shall be
borne as follows:
(a) Elan will bear all costs and expenses (internal and external)
incurred prior to 31 December 2002 (the "AMENDMENT DATE") and
associated with performing its obligations under this Agreement,
including without limitation Section 3.4 above, and the
implementation of the Plan prior to the Amendment Date.
(b) Subject to Section 4.5, Amarin shall be responsible for all
reasonable and verifiable Out Of Pocket Costs, whether
incurred by Elan, Amarin or a third party where such Out Of
Pocket Costs have been approved previously by the Steering
Committee and such Out Of Pocket Costs are not attributable to
a negligent act or omission or breach of the terms of this
Agreement or the Assignment Agreement by, or on behalf of,
Elan.
(c) Each party shall be responsible for its costs and expenses which are
not Out Of Pocket Costs in connection with (i) Elan's activities
pursuant to Section 3.4 and/or (ii) the implementation of the Plan,
incurred on or after the Amendment Date.
For the purposes of this Section 4.4, "OUT OF POCKET COSTS" shall mean
all amounts payable to third parties, including without limitation
contractors, incurred on or after the Amendment Date in connection with
(i) Elan's activities pursuant to Section 3.4 and/or (ii) the
implementation of the Plan."
3.5. After Section 4.4 there shall be added the following new Sections
4.5 and 4.6:
"4.5 Process and Audit.
(a) Within 15 days of the end of each calendar month following the
Amendment Date, Elan and Amarin shall provide to each other a
statement of their Out Of Pocket Costs incurred in the
previous calendar month. Within 15 days thereafter, Amarin
shall pay to Elan an amount equivalent to such Out Of Pocket
Expenses of Elan.
(b) For the 90 day period following the close of each calendar
year, Amarin and Elan will, in the event that the other party
reasonably requests such access, provide each other's
independent certified accountants (reasonably acceptable
to the other party) with access, during regular business
hours and subject to the confidentiality provisions as
contained in this Agreement, to such party's books and
records relating to Out Of Pocket Costs, solely for the
purpose of verifying the accuracy and reasonable
composition of the calculations hereunder for the
calendar year then ended.
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(c) In the event of a discovery of a discrepancy which exceeds
five per cent (5%) of the amount due or charged by a party for
any period, the cost of such audit shall be borne by the
audited party; otherwise, such cost shall be borne by the
auditing party.
4.6 Credit. Amarin shall be entitled to recover one half of Amarin's and
Elan's Out Of Pocket Costs previously approved by the Steering Committee
as a credit against the amount payable under Section 7.2(a), up to a
maximum credit of Five Million Dollars ($5,000,000). For the avoidance of
doubt, in the event that Amarin does not exercise the Option, or the
amount under Section 7.2(a) otherwise does not become payable for any
reason, Amarin shall not be entitled to any refund or contribution in
respect of Out Of Pocket Costs of Amarin or Elan."
3.6. Section 7.1 shall be deleted in its entirety and replaced with the
following:
"7.1 Purchase Price. Amarin shall pay to Elan:
(a) if (x) the Approval Date is prior to 30 September 2003 and (y)
Amarin is not in default of its payment obligations under the
Loan Agreement dated 28 September 2001 (as amended) with Elan
or the Amended and Restated Distribution, Marketing and
Option Agreement dated 28 September 2001 (as amended) (which
agreement concerns the product Permax) by and between Elan
Pharmaceuticals, Inc. and Amarin, other than a clerical or
administrative error in respect of the calculation of
interest under the Loan Agreement, written notice of which
default has been given by Elan, or as the case may be by the
Elan Affiliate, to Amarin and (z) Amarin so elects by written
notice to Elan at the time of exercise of the Option, the
following non-refundable amounts:
(i) Two Million Two Hundred and Fifty Thousand Dollars
($2,250,000) upon closing of the Option, which shall occur
on a mutually agreed date as soon as practicable after the
exercise of the Option; and
(ii) Eight Million Dollars ($8,000,000) ninety (90) days from the
Approval Date, but in no event later than the later of (x)
exercise of the Option and (y) 30 September 2003;
(b) in all other cases, the non-refundable amount of Ten Million
Dollars ($10,000,000) upon closing of the Option.
Such payment or payments shall not be subject to any future performance
obligations of Elan to Amarin and shall not be applicable against any
future services provided by Elan to Amarin."
3.7. Section 7.2(a) shall be varied by the deletion of the words "Twelve
Million Five Hundred Thousand Dollars ($12,500,000)" and the substitution
therefor of the words "Seventeen Million Five Hundred Thousand Dollars
($17,500,000)".
3.8. After Section 8.3 there shall be added the following new Section 8.4:
"8.4 Elan may terminate this Agreement and the Option in the event
that:
(a) Amarin materially breaches any agreement (other than this Agreement)
between Amarin and Elan or any Elan Affiliate, which breach is not
remedied within 90 (ninety) days of Elan giving written notice to
Amarin of such breach;
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(b) Amarin is unable to pay its debts as they fall due, commences
negotiations with any one or more of its creditors (other than Elan
and/or Elan Affiliates) with a view to the general readjustment or
rescheduling of its indebtedness or makes a general assignment for
the benefit of or composition with its creditors;
(c) Amarin takes any corporate action or other steps are taken or legal
proceedings are started for its winding up (which are not
dismissed or struck out within seven days of presentation), or
for its dissolution, administration or re-organisation (other
than in connection with a bona fide solvent restructuring) or
for the appointment of a liquidator, receiver, administrator,
administrative receiver, trustee or similar officer of it or
of all or a substantial part of its revenues and assets; or
(d) any execution or distress is levied against, or an encumbrancer
takes possession of, the whole or any substantial part of, the
property, undertakings or assets of Amarin or any event occurs which
under the laws of any jurisdiction has a similar or analogous
effect."
3.9. Section 9 shall be varied by the addition of the words "and the
Option" between the words "...immediately terminate this Agreement"
and "by written notice...".
3.10. Section 10.3 shall be varied by the addition of the words ", Section 8.4
and Section 9" after the words "Section 8.3".
4. CONFIRMATION OF THE AGREEMENT
Save as varied by this Deed, the parties hereto confirm that the Agreement shall
continue in full force and effect in all respects.
5. EXECUTION AND DELIVERY
5.1. Each of the parties to this document intends it to be a Deed and agrees
that upon it being dated it shall be treated as having been delivered as
a Deed.
5.2. The signing of this Deed by or on behalf of the parties hereto shall
constitute an authority to their respective solicitors (or any of them)
or any agent or an employee of them to date it as a Deed on behalf of the
parties.
6. MISCELLANEOUS
6.1. The provisions of Article 10 (Miscellaneous) of the Agreement shall be
incorporated into this Deed mutatis mutandis.
IN WITNESS whereof the parties have executed and delivered this Deed the date
first above written.
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EXECUTED as a DEED by )
AMARIN CORPORATION PLC )
acting by:- )
Director /s/ Xxxxxxx Xxxxxxx
Secretary /s/ Xxxxxxxx Xxxx
SIGNED and delivered as a Deed )
by ) /s/ Xxxxx Xxxxxx
as attorney for )
ELAN PHARMA INTERNATIONAL )
LIMITED )
in the presence of: )
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Signature of witness
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