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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F/A
AMENDMENT NO. 1
TO
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2001
Commission file number 0-21392
AMARIN CORPORATION PLC
(Exact name of Registrant as Specified in its Charter)
ENGLAND
(Jurisdiction of Incorporation or organization of Issuer)
7 CURZON STREET
LONDON W1Y 7FL
ENGLAND
(Address of Principal Executive Offices)
Securities registered or to be registered pursuant to
Section 12(b) of the Act:
Title of Name of each Exchange
each Class On Which Registered
None None
Securities registered or to be registered pursuant to
Section 12(g) of the Act:
American Depositary Shares Representing Ordinary Shares
Ordinary Shares (10p par value per Share)
Securities for which there is a reporting obligation pursuant
to Section 15(d) of the Act: None
Indicate the number of outstanding shares of each issuer's
classes of capital or common stock as of the period covered
by the annual report.
76,743,893 Ordinary Shares (10p par value per Share)
4,129,819 Preference Shares (1 pound par value Share)
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to
file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes [ X ] No [ ]
Indicate by check mark which financial statement item the
registrant has elected to follow.
Item 17 [ ] Item 18 [ X ]
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS
DURING THE PAST FIVE YEARS)
Indicate by check mark whether the registrant has filed all
documents and reports required to be filed by Sections 12,
13 or 15(d)of the Securities Exchange Act of 1934 subsequent
to the distribution of securities under a plan confirmed by
a court.
Yes [ ] No [ ]
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EXPLANATORY NOTE
Amarin Corporation plc (the "Company") hereby amends its Annual
Report on Form 20-F for the fiscal year ended December 31, 2001
pursuant to Rule 12b-15 under the Securities Exchange Act of
1934, as amended, by setting forth herein the complete text of
Exhibit 4.1, Option Agreement dated as of June 18, 2001 between
Elan Pharma International Limited and the Company. No other changes
are being made to the original Annual Report on Form 20-F for the
fiscal year ended December 31, 2001 (the "Original Filing").
This report continues to speak as of the date of the Original
Filing, and we have not updated the disclosure in this report to
speak as of a later date.
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SIGNATURES
Pursuant to the requirements of Section 12 of the Securities
Exchange Act of 1934, the Registrant certifies that it meets
all of the requirements for filing on Form 20-F and has duly
caused this annual report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AMARIN CORPORATION PLC
By: /s/ Richard A B Stewart
-------------------------
Name: Richard A B Stewart
Title: Chief Executive Officer
Date: February 25, 2003
SECTION 302 CERTIFICATION
I, Rick Stewart, Chief Executive Officer of Amarin Corporation plc,
certify that:
1. I have reviewed this annual report on Form 20-F/A of Amarin
Corporation plc; and
2. Based on my knowledge, this report does not contain any untrue
statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect
to the period covered by this report.
Date: February 25, 2003
/s/ Rick Stewart
_________________________
Rick Stewart
Chief Executive Officer
SECTION 302 CERTIFICATION
I, Darren Cunningham, Chief Financial Officer of Amarin Corporation plc,
certify that:
1. I have reviewed this annual report on Form 20-F/A of Amarin
Corporation plc; and
2. Based on my knowledge, this report does not contain any untrue
statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect
to the period covered by this report.
Date: February 25, 2003
/s/ Darren Cunningham
_________________________
Darren Cunningham
Chief Financial Officer
EXHIBIT INDEX
Exhibits filed as part of this annual report
1.1 Memorandum of Association of the Company (1)
1.2 Articles of Association of the Company (2)
1.3 Amendment to Articles of Association of Ethical
Holdings plc (3)
2.1 Deposit Agreement dated as of March 29, 1993, among the
Company, Citibank, N.A., as Depositary and all holders
from time to time of American Depositary Receipts issued
thereunder (1)
2.2 Amendment No. 1 to Deposit Agreement, dated as of
October 8, 1998, among the Company, Citibank, N.A.,
as Depositary and all holders from time to time of the
American Depositary Receipts issued thereunder (4)
2.3 Form of Ordinary Share certificate (1)
2.4 Form of American Depositary Receipt evidencing ADSs
(included in Exhibit 1.6) (1)
2.5 Purchase Agreement, dated as of June 16, 2000, by and
among Amarin Corporation plc and the Purchasers named
therein (3)
2.6 Registration Rights Agreement, dated as of November 24,
2000, by and between Amarin Corporation plc and Laxdale
Limited (5)
4.1 Option Agreement dated as of June 18, 2001 between Elan
Pharma International Limited and the Company*
4.2 Lease dated August 6, 2001 between the Company and
LB Strawberry LLC
4.3 Stock and Intellectual Property Right Purchase Agreement
dated November 30, 2001 by and among Abriway
International S.A., Sergio Lucero, Francisco Stefano,
Amarin Technologies S.A., Amarin Pharmaceuticals Company
and the Company
4.4 Stock Purchase Agreement dated November 30, 2001 by and
among Abriway Corporation plc, Beta Pharmaceuticals
Corporation and the Company
4.5 Novation Agreement dated November 30, 2001 by and among
Beta Pharmaceuticals Corporation, Amarin Technologies
S.A. and the Company
8.1 Subsidiaries of Amarin Corporation plc
* Confidential portions of this Exhibit have been omitted
pursuant to a request for confidential treatment. The
omitted confidential information has been filed with the
Securities and Exchange Commission.
(1) Incorporated herein by reference to certain exhibits to the
Company's Registration Statement on Form F-1, as amended, File
No. 33-58160, filed with the Securities and Exchange Commission
(2) Incorporated herein by reference to certain exhibits to the
Company's Registration Statement on Form F-1, as amended, File
No. 33-77560, filed with the Securities and Exchange Commission
(3) Incorporated herein by reference to certain exhibits to the
Company's Annual Report on Form 20-F for the year ended
December 31, 1999, filed with the Securities and Exchange
Commission
(4) Incorporated herein by reference to Exhibit (a)(1) to the
Company's Registration Statement on Form F-6, as amended,
File No. 333-5946, filed with the Securities and Exchange
Commission
(5) Incorporated herein by reference to certain exhibits to the
Company's Registration Statement on Form F-3, as amended, File
No. 33-13200, filed with the Securities and Exchange Commission
Exhibit 4.1
Certain portions of this Exhibit have been omitted pursuant to
a request for "Confidential Treatment" under Rule 24b-2 of the
Securities and Exchange Commission. Such portions have been
redacted and bracketed in the request and appear as [ ] in
the text of this Exhibit. The omitted confidential information
has been filed with the Securities and Exchange Commission
OPTION AGREEMENT
THIS OPTION AGREEMENT, dated as of June 18, 2001 (the
"Agreement"), is entered into between AMARIN CORPORATION, plc,
a public limited company organized under the laws of the United
Kingdom ("Amarin"), having its principal place of business at
7 Curzon Street, London W1Y 7FL, UK, and ELAN PHARMA
INTERNATIONAL LIMITED, a corporation organized under the laws
of Ireland ("Elan"),having its principal place of business at
WIL House, Shannon Business Park, Shannon, County Clare,
Ireland, each for themselves and their respective affiliates.
RECITALS
A. Elan is the owner or exclusive licensee of certain Rights
(as defined below) relating to a Zydis(r) formulation of
selegeline hydrochloride (the Product) presently known as
Zelapar(tm), which may have utility in the treatment of
Parkinson's disease and other diseases or conditions.
B. Amarin wishes to evaluate these Rights and to obtain an
exclusive option for a transfer and assignment of such Rights
in the Territory in the Field, each as defined below, and Elan
is willing to make such disclosure as may be relevant to Amarin
for purposes of its evaluation, and to grant such option for a
transfer and assignment of the Rights upon the terms and
conditions hereinafter set forth.
C. Elan and Amarin, should Amarin exercise its Option (as
defined below), wish to enter into an Assignment Agreement
for the Rights in the Territory in the Field; and in the
meantime, to establish a steering committee for the management
of the completion of development of Zelapar in the Territory.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing and the
mutual covenants set forth below, the parties hereby agree
as follows:
1. Rights Subject to Option; Information Provided to Amarin.
1.1 Rights Defined. For the purposes of this
Agreement, "Rights" shall mean all of Elan's right, title
and interest in any data, information, or know-how pertaining
to, and any license or other rights in, the Product in the
Territory, now owned or controlled or hereafter acquired by
Elan. By way of illustration, the foregoing Rights shall
include but not be limited to (i) all of Elan's rights under
the License and Supply Agreement between Elan or its
affiliates and RP Scherer and Company, as amended (the
"Scherer Agreement"), as it pertains to the Territory, and
(ii) all clinical, preclinical and other data, protocols,
inventory, work in progress, regulatory rights or
applications of any kind (such as a New Drug Application
("NDA") for the Product), contract rights, market research,
patent rights, patent applications, trademark rights,
trademark applications, and any know-how associated with the
Product for use in the Territory.
1.2 Information. Elan shall provide Amarin with
continuing access to and, as appropriate, copies or samples of
materials it has within its possession or control which are the
subject of the Rights, together with all additional
information, data, patent or trademark disclosures and know-how
relating thereto now known to or hereafter developed or
obtained by Elan during the Option Period (as defined below)
(the "Information"), all on the terms and subject to the
conditions of this Agreement.
2. Evaluation by Amarin.
2.1 Right to Evaluate. During the Option Period,
Amarin shall have the continuing right to review the
Information as Amarin determines is necessary to evaluate its
interest in exercising the Option. During the Option Period,
Amarin shall use the Information solely for that purpose.
Elan shall make the Information available at its expense at
800 Gateway Blvd, South San Francisco, California 94080.
2.2 Return of Information if Option not Exercised.
If Amarin terminates (which can occur only as provided in
Section 8.2 below) or fails to timely exercise the Option,
Amarin shall return to Elan, within thirty (30) days following
the termination of the Option Period, all Information of Elan
and all copies thereof (or Amarin's written confirmation that
it has destroyed all such copies), except for one complete set
of Information which Amarin may retain and use solely for
compliance purposes under the confidentiality requirements of
this Agreement.
3. Option to License.
3.1 Grant of Option.
(a) Elan hereby grants to Amarin the following
exclusive option (the "Option"), during the Option Period,
to obtain an exclusive transfer and assignment of the Rights,
on the terms stated below and in Exhibit A attached hereto and
incorporated by this reference, to use,promote, distribute and
sell the Product in the Territory, for use in the field of
human therapeutic treatment of any disease, condition or
disorder (the "Field"). It is understood and agreed that Elan
retains all rights in the Product outside the Territory which
it now or hereafter may own or control. For the purposes of
this Agreement, the Territory shall mean the United States.
(b) This Option is exercisable by written notice to
Elan received at any time during the Option Period. If Amarin
timely exercises the Option, the parties promptly shall
negotiate in good faith and execute a mutually acceptable
definitive assignment agreement (the "Assignment Agreement")
which shall incorporate the terms and conditions set forth in
this Agreement and shall include other terms and conditions
which are reasonable and customary in transactions of this
nature.
(c) If the parties are unable to agree upon the form
of the Assignment Agreement within thirty days of the date of
the exercise of the Option, the parties shall submit any
outstanding issues to senior management of each party, who
shall negotiate in good faith a resolution. If thirty days
after such submission to senior management issues remain
unresolved, either party may submit its proposed Assignment
Agreement to an arbitrator in the San Francisco, California
area, selected under the then-current Commercial Rules of the
American Arbitration Association, who will select one of the
two proposed agreements, in its entirety. The arbitrator's
decision will be final, binding and enforceable in a court of
competent jurisdiction in San Francisco, California, which
shall have exclusive jurisdiction over the matter.
(d) Among other things, the Assignment Agreement shall
provide that Amarin shall assume and perform Elan's obligations
under the Scherer Agreement as of the date of the transfer and
assignment of the Rights; that in the event of a conflict
between the Scherer Agreement and the Assignment Agreement, the
Scherer Agreement shall control; and that the parties shall
cooperate reasonably to enable the other to fulfill their
respective remaining obligations under the Scherer Agreement in
and outside the Territory.
3.2 Option Period. The "Option Period" shall mean
the period commencing on the date of this Agreement and
expiring at 5:00 p.m. Pacific time on the day which is the
earlier of the following: (i) thirty (30) days from the date on
which Amarin receives a copy of the written approval of a New
Drug Application ("NDA") by the Food and Drug Administration
("FDA") for immediate marketing of Zelapar in the Territory or
(ii) execution by both parties of the Assignment Agreement.
3.3 Option Fees. In full consideration for the
Option granted to Amarin, within three (3) business days of
execution of this Agreement by both parties, Amarin shall pay
to Elan a non-refundable, non-creditable option fee of One
Hundred Thousand Dollars ($100,000).
3.4 Pursuit of New Drug Application. During the
Option Period, Elan shall be responsible for and shall use
Commercially Reasonable Efforts to diligently pursue the
preparation, submission, acceptance for filing and substantive
review, and approval of an NDA for the Product with the FDA;
shall continue the prosecution and maintenance of all its
patents, patent applications, trademarks and trademark
applications included in the Rights; and shall consult with
and consider the reasonable requests of Amarin in connection
with the above. "Commercially Reasonable Efforts" of a Party
shall mean efforts consistent with the exercise of its prudent
business judgment as applied to other clinical, regulatory and
commercialization efforts for products of similar performance
and potential as would be undertaken in the pharmaceutical
industry, but not less than those efforts applied by that Party
to other similar products of its own product line.
4. Steering Committee.
4.1 Formation of Steering Committee. Promptly
following execution of this Agreement, the Parties will agree
on a Zelapar Steering Committee consisting of an equal number
of Elan and Amarin members. The initial chair of the Steering
Committee shall be designated by Elan and shall rotate between
Elan and Amarin at least annually. Elan and Amarin may each
designate a proxy or substitute for its members, and may
substitute its members.
4.2 Steering Committee Meetings; Project Plan. The
Steering Committee will meet within thirty (30) days of
execution of this Agreement, at 800 Gateway Blvd., South San
Francisco, California 94080, and no less than quarterly
thereafter at a site to be mutually agreed, with minutes and
next quarter objectives to be distributed by the chair and
approved; each party will pay its own expenses in attendance
and related activities. A draft of the plan for completion of
development and approval of an NDA for the Product (the "Plan")
will be drafted by Elan for review and approval, not to be
unreasonably withheld, by Amarin. The Plan will contain
milestone events and timelines for review and approval by the
Steering Committee. Thereafter, the Plan may be amended only by
majority vote of the Steering Committee. Material deviations in
executing the Plan must be approved in advance by the Steering
Committee. It is understood and agreed that Elan will perform
and manage the day-to-day execution and operations of the Plan.
Disputes not resolved by the Steering Committee within fourteen
(14) days shall be referred to respective company senior
management for good faith discussion and resolution.
4.3 Project Team. In addition to the Steering
Committee, Amarin shall be entitled to attend and participate
in and receive all materials provided to Elan's Project Team
for Zelapar.
4.4 Expenses. In return for the consideration
provided under this Agreement upon exercise of the Option,
Elan will bear all costs and expenses (internal and external)
associated with performing its obligations under this
Agreement, including without limitation Section 3.4 above,
and the implementation of the Plan.
5. Confidentiality.
5.1 Confidential Information. Except as otherwise
provided in this Section 5, during the term of the Option
Period, each party shall maintain in confidence all
information of the other party (including any Product samples)
disclosed by the other party under the Agreement (the
"Confidential Information"), and shall not use, disclose or
grant the use of the Confidential Information of the other
party, except to its and its affiliates' directors, officers,
employees, permitted assignees, agents, consultants, clinical
investigators and contractors, to the extent such disclosure
is reasonably necessary in connection with such party's
activities as expressly authorized by the Agreement. To the
extent that disclosure is authorized by the Agreement, prior
to disclosure, each party hereto shall obtain agreement of
any such person or entity to hold in confidence and not make
use of the Confidential Information for any purpose other than
those permitted by the Agreement. Each party shall notify the
other promptly of any unauthorized use or disclosure of the
other party's Confidential Information.
5.2 Permitted Disclosures. The confidentiality
obligations contained in Section 5. 1 above shall not apply
to the extent that (a) the receiving party (the "Recipient")
is required to disclose Confidential Information by law,
order or regulation of a governmental agency or a court of
competent jurisdiction, provided that the Recipient shall
provide to the disclosing party written notice and sufficient
opportunity to object to such disclosure or to request
confidential treatment thereof; or (b) the Recipient can
demonstrate that (i) the Confidential Information was public
knowledge at the time of such disclosure by the Recipient,
or thereafter became public knowledge, other than as a result
of actions of the Recipient, its affiliates and licensees in
violation hereof; (ii) the Confidential Information was
rightfully known to or independently developed by the
Recipient, its affiliates or licensees (as shown by its
written records) prior to the date of disclosure to the
Recipient by the other party hereunder; or (iii) the
Confidential Information was received by the Recipient,
its affiliates or licensees on an unrestricted basisfrom
a source unrelated to any party to the Agreement and not
under a duty of confidentiality to the other party.
5.3 Terms of the Agreement and Use of Name. Except
as otherwise provided in Sections 2.2 and 5.2 above, Elan and
Amarin shall not disclose any terms or conditions of the
Agreement to any third party without the prior consent of the
other party, not to be unreasonably withheld.
6. Representations, Warranties and Covenants.
6.1 Elan. Elan represents and warrants that it has
the full right and authority, and has taken all necessary
corporate action, to provide access to the Information, grant
Amarin the exclusive Option and, if exercised, enter into the
Assignment Agreement as set forth in this Agreement. Elan
warrants that Elan's entering into and performing this Agreement
will not conflict with or create a default under any agreement
or obligation binding on Elan or any of the assets or property
which are the subject of this Agreement.
Elan further warrants that:
(a) it is the sole owner or exclusive licensee of the
Rights (with full right to grant the option and transfer and
assign under any license agreement, without the necessity of
obtaining any consents of third parties other than Scherer,
and that such right, title and interest is unencumbered by
any lien, charge, claim or encumbrance of any kind; and
(b) it is the sole owner or exclusive licensee (with
the full right to sublicense under any license agreement,
without the necessity of obtaining any consents except
Scherer) of the patent(s) or patent applications in the
Territory which claim fast-dissolving drug delivery systems
which Scherer owns or under which Scherer is licensed with the
right to sublicense (the "Patent Rights"); Exhibit B contains
a complete and accurate listing of the Patent Rights (plus
certain other patent rights outside of the Territory, to
which Elan makes no representation or warranty) as of the
date of the Scherer Agreement, which Elan has no reason to
believe is inaccurate or incomplete; and to Elan's
knowledge, the Patent Rights are unencumbered by any lien,
charge, claim or encumbrance of any kind.
(c) from now through the expiration or termination of
this Agreement or the exercise of the Option, whichever first
occurs, Elan shall not convey, sell, transfer, license,
assign or encumber any interest in any of the Rights,
including without limitation the Information or Patent Rights,
or agree to do any of the foregoing.
6.2 Amarin. Amarin represents and warrants that it
has the full right and authority, and has taken all necessary
corporate action, to enter into and perform its obligations
under this Agreement and, if the Option is exercised, enter
into the Assignment Agreement as set forth in this Agreement.
Amarin warrants that its entering into and performing this
Agreement will not conflict with or create a default under
any agreement or obligation binding on Amarin. Following the
exercise of the Option, Amarin shall not sell, assign,
transfer, convey, license or otherwise substantially dispose
of the Rights in and to the Product to a third party (except
as provided in Section 10.3 below) without the prior written
consent of Elan, not to be unreasonably withheld.
7. Financial Terms; Purchase Price, Milestone Payments, Royalty.
7.1 Purchase Price. Upon the closing of the Option, which
shall occur on a mutually agreed date as soon as practicable after
the exercise of the Option, Amarin shall pay to Elan the amount of
Ten Million Dollars ($10,000,000). This payment 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.
7.2 Milestone Payments. Amarin shall pay Elan one-time
milestone payments based upon annual revenues from the sale of
theProduct in the Territory as follows:
(a) Following exercise of the Option, Amarin shall make a
one-time payment of Twelve Million Five Hundred Thousand Dollars
$12,500,000) payable within sixty (60) days of the end of the
first successive twelve months in which Net Sales of the Product
in the Territory in that twelve month period exceed fifteen
million dollars $15,000,000).
(b) Following the time period described in (a) above,
Amarin shall make a second one-time payment of Fifteen Million
Dollars($15,000,000) payable within sixty (60) days of the end of
the first successive twelve months in which Net Sales of the Product
in the Territory in that twelve month period exceed twenty million
dollars $20,000,000), provided that such twelve-month period shall
not overlap with the twelve month period described in (a) above.
(c) Amarin shall make a third one-time payment of Fifteen
Million Dollars ($15,000,000) payable on the eighth anniversary of
the exercise of the Option, unless extended by reason of the payment
in subparagraph (b) above not yet having been made; in which case the
third payment shall not be due until the day on which that prior
milestone payment is due. This payment shall be reduced by the amount
of royalty payments made under Section 7.3, below.
For the purposes of this Agreement: "Launch Year" shall mean a
consecutive twelve-month period beginning on the date of the
first commercial sale of the Product following approval of the
NDA, or on a subsequent anniversary of that date. "Net Sales"
shall mean the aggregate gross sales of the Product by Amarin
and its Affiliates (other than sales among Amarin and its
Affiliates) determined in accordance with UK generally accepted
accounting principles, consistently applied ("GAAP"), less the
following as specifically incurred for the Product: cash, trade
or quantity discounts; sales, use, tariff, or other excise taxes
imposed upon particular sales; transportation charges; and other
credits or allowances, including those granted on account of
prices, adjustments, wholesaler chargebacks, returns or rebates,
if any are incurred or granted. In connection with all amounts
based upon Net Sales payable to Elan pursuant to this Agreement,
upon Elan's request Amarin shall provide documentation supporting
any of the deductions to Net Sales set forth above. Any other
sales or transfers among Amarin or Amarin Affiliates shall not be
included in the definition of Net Sales. In such cases Net Sales
shall be determined based on the invoiced sale price by the
Affiliate to the first third party trade purchaser, less the
deductions allowed under this definition. Deductions to arrive at
Net Sales shall be determined in accordance with GAAP. Elan shall
have the right, upon reasonable advance written notice to Amarin
and during regular business hours, to inspect the records of Amarin
relating to the calculation of Net Sales hereunder. Such inspection
shall be conducted by an independent third party auditor chosen by
Elan and reasonably acceptable to Amarin. Such inspection shall be
at Elan's cost, unless a discrepency in payment of more than 5% is
found, in which case, it shall be at Amarin's cost. The parties
shall reconcile any discrepancy found within 30 days of receipt of
the report of the auditor. Elan's audit right, as described, shall
survive any expiration or termination of this Agreement, such that
Elan's right shall survive one (1) year beyond payment by Amarin of
the final payment to Elan owed hereunder.
7.3 Royalty Payments. For the first eight (8) Launch Years,
Amarin shall pay Elan a royalty of [ ] percent ([ ]%) of Net
Sales during that period, payable no more than forty-five (45) days
from the end of each calendar quarter for which a payment is due.
The total of all such payments made shall be credited against the
third milestone payment described in Section 7.2(c) above.
8. Termination.
8.1 The Option shall terminate without further notice or
action upon the expiration of the Option Period if Amarin fails to
timely exercise the Option as provided in this Agreement.
8.2 Amarin may terminate the Option prior to expiration
of the Option Period at any time only by notifying Elan in a writing
(signed by the CEO or the President of Amarin) of its decision not
to exercise the Option and specifically referring to this Agreement.
8.3 Elan may terminate this Agreement and the Option in
the event of a Change of Control of Amarin. For the purposes of this
Agreement, a Change of Control of Amarin shall mean circumstances
where any third party shall, directly or indirectly, acquire fifty
percent (50%) or more of the then voting stock of Amarin, or otherwise
merge, consolidate or enter into any similar transaction (or binding
agreement in respect thereof) with Amarin in a transaction after
which Amarin is not the controlling entity.
9. Default. Subject to Section 6.2 above, if either party fails
to perform or fulfill at the time and in the manner herein provided
any material obligation or condition required to be performed by
such party (the "Defaulting Party") hereunder, and if such Defaulting
Party fails to remedy such default within thirty (30) days after
written notice thereof from the non-defaulting party, the non-
defaulting party shall have the right to immediately terminate the
Agreement by written notice to the Defaulting Party, in addition to
any other rights it may have.
10. Miscellaneous.
10.1 Notices. Any consent, notice or report required or
permitted to be given or made under the Agreement by one of the
parties hereto to the other party shall be in writing, delivered
personally or by facsimile (and promptly confirmed by personal
delivery, U.S. first class mail or courier), U.S. first class
mail or courier, postage prepaid (where applicable), addressed
to such other party at its address indicated below, or to such
other address as either party may notify the other in
accordance with this Section, and (unless otherwise provided
in this Agreement) shall be effective upon receipt by the
addressee.
If to Amarin: Amarin Corporation, plc
7 Curzon Street
London W1Y 7FL, UK
Attention: CEO
Facsimile: +44-207-499-9004
Attn: Chief Executive Officer
with a copy to: Amarin Corporation, plc
Two Belvedere Place, Suite 330
Mill Valley, California 94941
Attention: Executive Vice
President, Legal
Facsimile: 415-389-4756
If to Elan: Elan Pharma International Limited
c/o Elan International Services Ltd
102 St. James Court, Flatts,
Smiths FL04, Bermuda
Attention: Director
Facsimile: 441-292-2224
10.2 Governing Law. The Agreement shall be governed by and
construed in accordance with the laws of the State of Delaware,
without regard to the conflicts of law principles thereof.
10.3 Assignment. Subject to Elan's right of termination
in Section 8.3, neither party shall assign its rights or
obligations under the Agreement without the prior written consent
of the other party hereto; provided, however, that either party
may, without such consent, assign the Agreement and its rights
and obligations hereunder to an affiliate, or in connection with
the transfer or sale of all or substantially all of its assets
or business, or in the event of its merger or consolidation or
change in control or similar transaction (again subject to
Elan's right of termination in the event of an Amarin Change of
Control), and provided further that any permitted assignee
assumes in writing all obligations of its assignor under this
Agreement.
10.4 Waivers and Amendments. No change, modification,
extension, termination or waiver of this Agreement shall be
valid unless made in writing and signed by duly authorized
representatives of the parties.
10.5 Entire Agreement. This Agreement, together with the
exhibits hereto, embodies the entire understanding between the
parties and supersedes any prior understanding and agreements
between and among them respecting the subject matter. There
are no representations, agreements, arrangements or
understandings, oral or written, between the parties relating
to the subject matter of the Agreement which are not fully
expressed herein.
10.6 Counterparts. The Agreement may be executed in two
or more counterparts, each of which shall be deemed an original,
but all of which together shall constitute one and the same
instrument.
[Remainder of Page Intentionally Left Blank]
10.7 Further Assurances. The parties shall take any other
actions, including without limitation the execution and delivery of
documents, as may be reasonable, necessary or appropriate to carry
out the intent of this Agreement.
IN WITNESS WHEREOF, the parties have duly executed and delivered the
Agreement as of the date first written above.
ELAN PHARMA
INTERNATIONAL LIMITED AMARIN CORPORATION, plc
By: ________________________ By:_________________________
Name:_________________________ Name:__________________________
Title: _________________________ Title:__________________________
Date: ________________________ Date: _______________________
EXHIBIT A
LOI AND TERM SHEET
elan pharma international limited
WIL House, Shannon Business Park
Shannon, County Clare, Ireland
Telephone (+353 611 382533, (+353 1) 709 4040
Fax (+353 61) 362097, (+353 1) 709 4082
June 18, 2001
Via Federal Express
Richard A B Stewart
Chief Executive Officer
Amarin Corporation plc
7 Curzon Street
London W1Y 7FL
UK
Re: Zelapar(tm) (Zydis(r) selegiline)
Dear Rick:
This will confirm the agreement of Elan Pharma International
Limited ("Elan") and Amarin Corporation, plc ("Amarin") to
enter into a transaction by which Elan will grant to Amarin
the exclusive option to acquire all of Elan's right, title
and interest in and to Zelapar in the United States, on the
terms contained in the attached Term Sheet, a copy of which
is attached and incorporated by this reference ("Term Sheet").
In that respect, Elan and Amarin will each use diligent
efforts to negotiate in good faith and enter into a
definitive option agreement (the "Agreement") which, in
addition to the attached terms, will contain such other terms
and conditions as are reasonable and customary in such
transactions. If the parties do not enter into the Agreement
on or before June 30, 2001, any remaining issues shall then be
referred to senior management for good faith resolution.
The agreed transaction under this letter and the Agreement will
be subject to the consent of any necessary third parties or
governmental entities, including without limitation Scherer DDS,
a division of R.P. Scherer Limited, or its successors in
interest. If required, Elan and Amarin will cooperate to use
diligent efforts to obtain any such consents as soon as is
practical.
This letter expresses our entire agreement on the subject matter,
supersedes any prior agreements (other than the Term Sheet) and
may not be amended except in writing signed by Elan and Amarin.
If the foregoing accurately sets out the agreement between
Amarin and Elan, please sign one of the two original enclosed
copies of this letter and return to me as soon as possible.
Best Regards,
David Hurley
Director
Acknowledged and Agreed:
Amarin Corporation, plc
By:___________________
Richard A B Stewart
TERM SHEET
ZELAPAR OPTION AND PURCHASE AGREEMENT
BETWEEN ELAN AND AMARIN
May 16, 2001
Product: Elan and Amarin would enter
into an agreement (the "Option
and Purchase Agreement") under
which Elan would transfer to
Amarin exclusive purchase
rights for Zelapar.
Supply: Supply contract(s) and
responsibilities will be
transferred from Elan to Amarin
no later than December 31, 2001.
Purchase Option
Payments: Amarin will pay Elan $100,000
for the option right to purchase
Zelapar outright. This amount
is payable on closing.
Purchase Option: Upon NDA approval Amarin will have
the option to purchase Permax
outright (the "Purchase Option").
Milestone payments are as follows:
The initial consideration of
$10,000,000 is payable on NDA
approval.
The second payment of $12,500,000
is payable once fiscal Zelapar
revenues reach or exceed $15,000,000.
The third payment of $15,000,000 is
payable once fiscal Zelapar revenues
reach or exceed $20,000,000.
The fourth payment of $15,000,000 is
payable in 2010. This payment can be
extended under certain circumstances.
Royalty Payments: Amarin will pay Elan [ ]% of
net sales as a part of the total
consideration and this amount can
be offset against the fourth
payment of $15,000,000. This royalty
is payable for eight years from NDA
approval.
Research and
Development Costs: Elan will pay all research,
development and filing costs up
to and including NDA approval.
Change of Control: In the event of a Change of
Control involving Amarin,
including an event that would
give rise to the triggering of
the CVRs, Elan shall have the
right to terminate this agreement
in which case all rights to Zelapar
will revert to Elan.
Subsequent
Disposal: Following the exercise of the
Purchase Option, Amarin will not
dispose of Zelapar to a third
party without the prior written
consent of Elan.
EXHIBIT B
PATENT RIGHTS
ATTACHMENT A
ZYDIS PATENTS
1 PRODUCT AND PROCESS
Country Patent No. Application No. Expiry Date
US 4371516 31/Jan/2000
2 PRODUCT AND PROCESS
Country Patent No. Application No. Expiry Date
Canada 1200960 24/Feb/2003
Mexico 174712 02/Dec/2002
Philippines 18441 07/Jul/2002
3 DOSING OF A PREFORMED MATRIX
Country Patent No. Application No. Expiry Date
Canada 1195250 14/Oct/2002
Mexico 168190 195530 09/Dec/2002
Philippines 18298 28/May/2002
US 4754597 05/Jul/2005
4 FREEZING IN A LIQUID MEDIUM
Country Patent No. Application No. Expiry Date
Canada 1197700 09/Dec/2002
Mexico 162818 27/Jul/2005
Philippines 17895 20/Jan/2002
Taiwan 23617 31/Oct/2000
US 4470202 26/Nov/2002
5 CHILD RESISTANT PACK
Country Patent No. Application No. Expiry Date
US 5046618 615489 19/Nov/2010
6 ION-EXCHANGE RESIN
Country Patent No. Application No. Expiry Date
US 5188825 458311 23/Feb/2010
7 BALANCED TRILAMINATE BLISTER FILM
Country Patent No. Application No. Expiry Date
Canada 2129254
Mexico 94/3749
US 08/841578
US 5729958 08/448469 01/Dec/2012
US 5343672 07/985040 01/Dec/2012
8 STEPPED-EDGE BLISTER PACK
Country Patent No. Application No. Expiry Date
Canada 2144538
US 5358118 08/198644 18/Feb/2014
9 EMBOSSING
Country Patent No. Application No. Expiry Date
Canada 2149659
Mexico 947546
US 08/619478
US 5457895 08/104486 01/Oct/2013
10 EMBOSSING ALUMINIUM
Country Patent No. Application No. Expiry Date
PCT PCT/GB98/02442
11 GLYCINE FORMULATIONS
Country Patent No. Application No. Expiry Date
Canada 333872
Mexico 932689
Philippines 46138
Taiwan 82104563
US 5648093 08/447253 15/Jul/2014
US 5558880 234295 24/Sep/2013
12 SELEGILINE - STABILISATION
Country Patent No. Application No. Expiry Date
US 08/894,765
13 SELEGILINE -PRE-GASTRIC ABSORPTION
Country Patent No. Application No. Expiry Date
Canada 2214026
Mexico 976647
US 08/894764