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EXHIBIT 10.7
TEXT OMITTED AND FILED SEPARATELY
"CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 240.24b-2."
LICENSE AGREEMENT
BETWEEN
ELAN CORPORATION, PLC
(ACTING THROUGH ITS DIVISION ELAN PHARMACEUTICAL TECHNOLOGIES)
AND
ELAN PHARMA INTERNATIONAL LIMITED
AND
HEPASENSE LTD.
JANUARY 14, 2000
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TABLE OF CONTENTS
1 DEFINITIONS
2 ELAN LICENSE TO HEPASENSE
3 INTELLECTUAL PROPERTY
4 NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
5 FINANCIAL PROVISIONS
6 RIGHT OF INSPECTION AND AUDIT
7 REPRESENTATIONS AND WARRANTIES
8 TERM AND TERMINATION
9 CONFIDENTIAL INFORMATION
10 GOVERNING LAW AND DISPUTE RESOLUTION
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
12 ASSIGNMENT
13 NOTICES
14 MISCELLANEOUS
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THIS AGREEMENT made this 14th January 2000
BETWEEN:
(1) ELAN CORPORATION, PLC, a public limited company incorporated under the
laws of Ireland, acting through its division ELAN PHARMACEUTICAL
TECHNOLOGIES and having its registered office at Xxxxxxx Xxxxx, Xxxxxxx
Xxxxx, Xxxxxx 0, Xxxxxxx and ELAN PHARMA INTERNATIONAL LIMITED, a
private limited company and having its registered office at XXX Xxxxx,
Xxxxxxx Xxxxxxxx Xxxx, Xxxxxxx, Xxxxxx Xxxxx, Xxxxxxx;
(2) HEPASENSE LTD., a private limited company incorporated under the laws of
Bermuda and having its registered office at 000 Xx. Xxxxx Xxxxx,
Xxxxxxxxx House, Church St., Hamilton, Bermuda; and
(3) ISIS PHARMACEUTICALS, INC., a corporation duly incorporated and validly
existing under the laws of the state of Delaware and having its
principal place of business at 0000 Xxxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx
00000, Xxxxxx Xxxxxx of America.
RECITALS:
A. Simultaneously herewith, Isis, Elan, EIS, and HepaSense (capitalized
terms used herein are defined below) are entering into the JDOA for the
purpose of recording the terms and conditions of the joint venture and
of regulating their relationship with each other and certain aspects of
the affairs of, and their dealings with HepaSense.
B. HepaSense desires to enter into this Agreement with Elan so as to permit
HepaSense to utilize the Elan Intellectual Property in making, having
made, importing, using, offering for sale and selling the Products in
the Field in the Territory.
C. Simultaneously herewith HepaSense and Isis are entering into the Isis
License Agreement relating to HepaSense's use of the Isis Intellectual
Property.
1 DEFINITIONS
1.1 In this Agreement unless the context otherwise requires:
"ADDITIONAL OLIGONUCLEOTIDES" shall mean another Oligonucleotide from
the Isis portfolio of Oligonucleotides nominated by Isis and accepted by
Elan to be incorporated within or packaged with the System for
commercialization. For the avoidance of doubt, the Parties acknowledge
that any Additional Oligonucleotide shall be at least at the same stage
of development as the Designated Oligonucleotide, i.e., shall be ready
for clinical testing;
"ADDITIONAL PRODUCTS" shall mean the pharmaceutical formulation
incorporating an
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Additional Oligonucleotide and incorporated within or packaged with the
System.
"AFFILIATE" shall mean any corporation or entity controlling, controlled
or under the common control of Elan or Isis, as the case may be. For the
purpose of this definition, "control" shall mean direct or indirect
ownership of fifty percent (50%) or more of the stock or shares entitled
to vote for the election of directors. HepaSense is not an Affiliate of
Elan or EIS.
"AGREEMENT" shall mean this license agreement (which expression shall be
deemed to include the Recitals and Schedules hereto).
"BUSINESS PLAN" shall have the meaning, as such term is defined in the
JDOA.
"COMPETITIVE CHANGE OF CONTROL EVENT" shall mean that a Primary
Technological Competitor of Elan acquires directly or indirectly voting
stock or equivalent securities in Isis or HepaSense representing [ * ]
percent or more of the stock which carries entitlement to vote, or a
Primary Technological Competitor of Elan acquires by all or
substantially all of the business of Isis or HepaSense to which the
Definitive Documents relate, whether by merger, sale of stock, sale of
assets or otherwise;
"CONFIDENTIAL INFORMATION" shall have the meaning, as such term is
defined in Clause 9.
"DEFINITIVE DOCUMENTS" shall mean the definitive agreements relating to
the transaction including finance, stock purchase, research and license
agreements.
"DESIGNATED OLIGONUCLEOTIDE" shall mean Isis 14803.
"EFFECTIVE DATE" shall mean the date of this Agreement.
"ELAN" shall mean Elan, plc and EPIL, and their respective successors
and permitted assigns.
"ELAN, PLC" shall mean Elan Corporation, plc, a public limited company
incorporated under the laws of Ireland acting through its division Elan
Pharmaceutical Technologies.
"EIS" shall mean Elan International Services, Ltd., a private limited
company incorporated under the laws of Bermuda and having its registered
office at Xx Xxxxx Xxxxx, Xxxxxx, Xxxxxx, XX00 Bermuda.
"ELAN IMPROVEMENTS" shall mean any enhancement or improvement relating
to the System, developed (i) by Elan whether or not pursuant to the
Project, (ii) by HepaSense or Isis or by a third party (under contract
with HepaSense) pursuant to the Project, and/or (iii) jointly by any
combination of Elan, Isis or HepaSense pursuant to the Project, except
as limited by agreements with third parties.
Subject to third party agreements, Elan Improvements shall constitute
part of Elan
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*CONFIDENTIAL TREATMENT REQUESTED
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Intellectual Property and be included in the license of the Elan
Intellectual Property pursuant to Clause 2.1 solely for the purposes set
forth therein; provided, however, that an enhancement or improvement
relating to the System which modifies the System in a manner for
delivery of a drug other than delivery of factory pre-programmed
continuous amounts of the drug shall remain the property of Elan but
shall not be included in the license of the Elan Intellectual Property
pursuant to Clause 2.1. If the inclusion of a Elan Improvement in the
license of Elan Intellectual Property is restricted or limited by a
third party agreement, Elan shall use reasonable commercial efforts to
minimize any such restriction or limitation.
For the avoidance of doubt, any enhancement or improvement relating to
both the System and the Isis Know-How or Isis Patents developed by any
of the parties individually or jointly pursuant to the Project or by a
third party (under contract with HepaSense) pursuant to the Project
shall, except as limited by agreements with third parties, be deemed to
be HepaSense Intellectual Property.
"ELAN INTELLECTUAL PROPERTY" shall mean the Elan Know-How, the Elan
Patents and the Elan Improvements. For the avoidance of doubt, Elan
Intellectual Property shall exclude inventions, patents and know-how
owned, licensed or controlled by Targon Corporation, Axogen Limited and
Neuralab Limited and by all Affiliates or subsidiaries (present or
future) of Elan, plc. within the division of Elan, plc carrying on
business as Elan Pharmaceuticals which incorporates, inter alia, EPIL
(to the extent that EPIL is the owner of patents, know-how or other
intellectual property or technology invented and/or developed within the
division of Elan, plc carrying on business as Elan Pharmaceuticals),
Athena Neurosciences, Inc., Elan Pharmaceuticals, Inc., Elan
Diagnostics, Carnrick Laboratories, and Elan Europe Limited.
"ELAN KNOW-HOW" shall mean any and all rights owned, licensed or
controlled by Elan to any scientific, pharmaceutical or technical
information, data, discovery, invention (whether patentable or not),
technique, process, procedure, system, formulation or design relating to
the System that is not generally known to the public.
"ELAN LICENSE" shall have the meaning set forth in Clause 2.1 hereof.
"ELAN PATENTS" shall mean any and all patents and patent applications as
set forth in Schedule 1, and all rights therein, and including all
extensions, continuations, continuations-in-part, divisionals,
patents-of-additions, re-examinations, re-issues, supplementary
protection certificates and foreign counterparts thereto owned by or
licensed to Elan containing claims relating to the System.
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"EPIL" shall mean Elan Pharma International Limited, a private limited
company incorporated under the laws of Ireland, that is wholly owned by
Elan, plc.
"FIELD" shall mean the administration of the Designated Oligonucleotide
by all routes of administration. Upon nomination by Isis and acceptance
by Elan of an Additional Oligonucleotide, the parties shall amend the
definition of the Field to include the administration of the Additional
Oligonucleotide by such means of administration as agreed to by the
parties.
Notwithstanding the foregoing, the Parties acknowledge and agree that,
pursuant to existing agreement among Elan, Isis and Orasense Ltd, both
Isis and Elan and their Affiliates may be subject to certain
restrictions concerning the development and commercialization of
products comprised upon the oral administration of any Oligonucleotide.
"FINANCIAL YEAR" shall mean each year commencing on 1 January (or in the
case of the first Financial Year, the Effective Date) and expiring on 31
December of each year.
"HCV" shall mean the hepatitis C virus.
"HEPASENSE INTELLECTUAL PROPERTY" shall mean HepaSense Patents and
HepaSense Know How. In addition to the foregoing, any enhancement or
improvement relating to both the System and the Isis Know-How or Isis
Patents developed by any of the Parties individually or jointly pursuant
to the Project or by a third party (under contract with HepaSense)
pursuant to the Project shall, except as limited by agreements with
third parties, be deemed to be HepaSense Intellectual Property.
"HEPASENSE KNOW-HOW" shall mean any and all rights owned, licensed or
controlled by HepaSense to any scientific, pharmaceutical or technical
information, data, discovery, invention (whether patentable or not),
technique, process, procedure, system, formulation or design that is not
generally known to the public arising out of the conduct of the Project
by any person that does not constitute Elan Improvements or Isis
Improvements.
"HEPASENSE PATENTS" shall mean any and all patents and patent
applications arising out of the conduct of the Project by any person
that does not constitute Elan Improvements or Isis Improvements and all
rights therein, and including all extensions, continuations,
continuations-in-part, divisionals, patents-of-additions,
re-examinations, re-issues, supplementary protection certificates and
foreign counterparts thereto owned or licensed to HepaSense.
"IN MARKET" shall mean the sale of the Product and Additional Products
in the Territory by HepaSense or its Affiliates, or where applicable by
a permitted sub-licensee, to an unaffiliated third party, such as (i)
the end-user consumer of the Product (ii) a wholesaler, managed care
organization, hospital or pharmacy or other third party who effects the
final commercial sale to the end-user consumer of the Product, and shall
exclude the transfer pricing of the Product(s) by Elan to an Affiliate
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or a sub-licensee.
"ISIS" shall mean Isis Pharmaceuticals, Inc. and its Affiliates,
excluding HepaSense.
"ISIS INTELLECTUAL PROPERTY" shall mean the Isis Know-How, the Isis
Patents and the Isis Improvements, as such terms are defined in the Isis
License Agreement.
"ISIS LICENSE" shall mean have the meaning set forth in Clause 2.1 of
the Isis License Agreement.
"ISIS LICENSE AGREEMENT" shall mean that certain license agreement, of
even date herewith, entered into between Isis and HepaSense.
"ISIS PATENTS" shall have the meaning as such term is defined in the
Isis License Agreement.
"ISIS IMPROVEMENTS" shall have the meaning as such term is defined in
the Isis License Agreement.
"ISIS 14803" shall mean the Oligonucleotide described in Exhibit A to
the Isis License Agreement.
"JDOA" shall mean that certain joint development and operating
agreement, of even date herewith, by and between Elan, Isis, EIS and
HepaSense.
"LICENSED TECHNOLOGIES" shall mean the Elan Intellectual Property and
the Isis Intellectual Property.
"LICENSES" shall mean the Elan License and the Isis License.
"NET SALES" shall mean that sum determined by deducting the following
deductions from the aggregate gross In Market sales proceeds billed for
the Products by HepaSense or, its Affiliate or a permitted sub-licensee,
as the case may be:
(i) transportation charges or allowances, if any, included in such
price;
(ii) trade, quantity or cash discounts, broker's or agent's
commissions, if any, allowed or paid;
(iii) credits or allowances, if any, given or made on account of price
adjustments, returns, promotional discounts, rebates and any and
all federal, state or local government rebates whether in
existence now or enacted at any time during the term of the
Licenses;
(iv) any tax, excise or governmental charge upon or measured by the
sale, transportation, delivery or use of the Products; and
(v) reasonable samples, materials for clinical studies and reasonable
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compassionate programs.
Net Sales shall also include the amount or fair market value of all
other consideration received by HepaSense or its Affiliates or
sublicensees in respect of Products and Additional Products, whether
such consideration is payment in kind, exchange or another form. If a
Product or Additional Product is provided to an third party by HepaSense
or its Affiliates or sublicensees without charge or provision of invoice
and used by such third party, then HepaSense or its Affiliates or
sublicensees shall be treated as having sold such Product or Additional
Product to such third party for an amount equal to the fair market value
of such Product. Sales between or among HepaSense and its respective
Affiliates or authorized licensees shall be excluded from the
computation of Net Sales. A "sale" of a Product or Additional Product is
deemed to occur upon the earlier of invoicing, shipment or transfer of
title in the Product or the Additional Product to an third party. For
avoidance of doubt, Net Sales shall include royalties received by
HepaSense or its Affiliates from any third party in respect of Products
and Additional Products.
"OLIGONUCLEOTIDE" shall mean any single stranded, [ * ] oligonucleotide
including those [ * ] used as a human therapeutic and/or prophylactic
compound containing between [ * ] nucleotides and/or nucleosides
including oligonucleotide analogs which may include [ * ]. For purposes
of this agreement, Oligonucleotide shall specifically exclude
oligonucleotides used in gene therapy except [ * ] an oligonucleotide,
oligonucleotides used as [ * ] or oligonucleotides used as adjuvants.
Oligonucleotide shall also specifically exclude polymers in which the
linkages are amide based, such as peptides and proteins and shall also
exclude [ * ].
"ORAL" shall mean administration by way of the mouth for the purpose of
topical or systemic delivery by way of the alimentary canal.
"PARTY" shall mean Elan or HepaSense, as the case may be, and "PARTIES"
shall mean Elan and HepaSense.
"PRIMARY TECHNOLOGICAL COMPETITOR OF ELAN" shall mean those entities
listed on Schedule 2A hereto.
"PRODUCT" shall mean the pharmaceutical formulation incorporating the
Designated Oligonucleotide for [ * ] within the Field, including,
without limitation, the incorporation of the Designated Oligonucleotide
within or packaged with the System.
"PROJECT" shall mean all activities as undertaken by Elan, Isis and
HepaSense in order to develop the Products
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*CONFIDENTIAL TREATMENT REQUESTED
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"SUBSTITUTE OLIGONUCLEOTIDE" shall have the meaning set forth in Clause
2.2 hereof;
"SYSTEM" shall mean an ambulatory drug delivery system for direct
attachment to the body of a patient having a flexible diaphragm drug
reservoir, which is capable of delivering factory pre-programmed
continuous amounts of drug upon activation as disclosed and described in
the Elan Patents set forth in Schedule 1 attached hereto.
"TECHNOLOGICAL COMPETITOR OF ELAN" shall mean a company, corporation or
person listed in Schedule 2B and successors thereof or any additional
broad-based technological competitor of Elan added to such Schedule from
time to time upon mutual agreement of the Parties.
"TERM" shall have the meaning set forth in Clause 8.
"TERRITORY" shall mean all the countries of the world.
"UNITED STATES DOLLAR" and "US$" shall mean the lawful currency for the
time being of the United States of America.
1.2 In this Agreement:
1.2.1 The singular includes the plural and vice versa, and the
masculine includes the feminine and vice versa and the neuter
includes the masculine and the feminine.
1.2.2 Any reference to a Clause or Schedule shall, unless otherwise
specifically provided, be to a Clause or Schedule of this
Agreement.
1.2.3 The headings of this Agreement are for ease of reference only and
shall not affect its construction or interpretation.
2 ELAN LICENSE TO HEPASENSE
2.1 Elan hereby grants to HepaSense for the Term an exclusive license
(including the limited right to grant sublicenses under Clause 10 of the
JDOA) (the "Elan License") to the Elan Intellectual Property to make,
have made, import, use, offer for sale and sell the Product in the Field
in the Territory, subject to any contractual obligations that Elan has
as of the Effective Date, including but not limited to the Development
License and Supply Agreement dated 26 July 1999 between EPIL and Merck
Corporation and the License Agreement dated as of April 20, 1999 between
Orasense Ltd, and Elan Pharmaceutical Technologies, and the
Manufacturing Agreement dated June 11, 1999 among Elan Corporation plc,
EPIL and MiniMed. Upon nomination by Isis and acceptance by Elan of an
Additional Oligonucleotide, the Parties shall negotiate in good faith
how the Additional Product based upon such Additional Oligonucleotide
should be developed and commercialized, whether a license should be
granted to Isis or HepaSense or otherwise, (i) the terms of a grant of a
new license of Elan Intellectual Property for use with the Additional
Oligonucleotide or (ii) the
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terms for amendment of the Elan License to include the license of the
Elan Intellectual Property to make, have made, import, use, offer for
sale and sell Additional Products based upon the Additional
Oligonucleotide in the Field in the Territory, subject to any
contractual obligations that Elan has as of the date of such agreement.
2.2 Elan hereby confirms that no financial or compensation obligations are
in effect on the date hereof between Elan and an unaffiliated third
party relating to the System for use in the Field.
To the extent royalty or other compensation obligations payable to third
parties with respect to the Elan Intellectual Property would be
triggered by use of such Elan Intellectual Property in connection with
the Project, Elan shall inform HepaSense and Isis of such royalty or
compensation obligations. If HepaSense and Isis agree to utilize such
Elan Intellectual Property in connection with the Project, HepaSense
will be responsible for the payment of such royalty or other
compensation obligations relating thereto.
2.3 Isis shall be a third party beneficiary under this Agreement and shall
have the right to cause HepaSense to enforce HepaSense's rights under
this Agreement against Elan.
2.4 Notwithstanding anything contained in this Agreement to the contrary,
Elan shall have the right outside the Field and subject to the
non-competition provisions of Clause 4 to exploit and grant licenses and
sublicenses of the Elan Intellectual Property.
For the avoidance of doubt, HepaSense shall have no right to use the
Elan Intellectual Property outside the Field.
2.5 Except as provided in Clause 10 in the JDOA, HepaSense shall not be
permitted to assign, license or sublicense any of its rights under the
Elan Intellectual Property and/or the HepaSense Intellectual Property
without the prior written consent of Elan.
2.6 Any agreement between HepaSense and any permitted third party for the
development or exploitation of the Elan Intellectual Property shall
require such third party to maintain the confidentiality of all
information concerning the Elan Intellectual Property and shall provide
that any Elan Improvements shall belong to Elan and shall permit an
assignment of rights by HepaSense to Elan in accordance with the terms
of this Agreement.
Insofar as the obligations owed by HepaSense to Elan are concerned,
HepaSense shall remain responsible for all acts and omissions of any
permitted sub-licensee, including Isis, as if they were acts and
omissions by HepaSense.
3 INTELLECTUAL PROPERTY
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3.1 OWNERSHIP OF INTELLECTUAL PROPERTY:
3.1.1 HepaSense shall own the HepaSense Intellectual Property.
3.1.2 Elan shall own the Elan Intellectual Property.
4 NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
4.1 Subject to Clause 4.2 hereof and Clause 14 of the JDOA, Elan, alone or
in conjunction with a third party, shall not, for a period of [ * ]
years from the Effective Date, develop or commercialize the Designated
Oligonucleotide or any other Oligonucleotide designated towards the
treatment of HCV, subject to (a) the Development, License and Supply
Agreement dated 26 July 1999 between EPIL and Merck Corporation, (b) the
Subscription, Joint Development and Operating Agreement, dated July 21,
1999, between Elan, plc, EIS, Targeted Genetics Corporation and Targeted
Genetics HepaSense, Ltd. and (c) the License Agreement, dated as of July
20, 1999, between Targeted Genetics HepaSense, Ltd. and Elan, plc.
Notwithstanding anything to the contrary contained herein, the
provisions of Clause 4.1 shall only act as a restriction upon Affiliates
and subsidiaries of Elan, plc. carrying on business as Elan
Pharmaceutical Technologies and, except for the development and
commercialization of any Oligonucleotide designated towards the
treatment of HCV administered by the System during such [* ] year
period, shall not act as a restriction upon, nor in any way affect,
Targon Corporation, Axogen Limited, Neuralab Limited, Affiliates and
subsidiaries (present or future) within the division of Elan, plc
carrying on business as Elan Pharmaceuticals which incorporates, inter
alia, EPIL (to the extent that EPIL is the owner of patents, know-how or
other intellectual property or technology invented and/or developed
within the division of Elan, plc carrying on business as Elan
Pharmaceuticals), Athena Neurosciences, Inc., Elan Pharmaceuticals,
Inc., Elan Diagnostics, Carnrick Laboratories, and Elan Europe Limited.
4.2 If, after the Effective Date, Elan obtains or licenses from a third
party know-how or patent rights relating to the System in the Field, or
acquires or merges with a third party entity that has know-how or patent
rights relating to the System in the Field, Elan shall offer to license
such know-how and patent rights to HepaSense (subject to existing
contractual obligations), on commercially reasonable terms on an arm's
length basis for a reasonable period under the prevailing circumstances.
If HepaSense determines that HepaSense should not acquire such license,
Elan shall be free to fully exploit such know-how and patent rights with
the Elan Intellectual Property then licensed to HepaSense, whether
inside or outside the Field, and to grant to third parties licenses and
sublicenses with respect thereto.
5 FINANCIAL PROVISIONS
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5.1 LICENSE FEE:
In consideration of the license by Elan to HepaSense of the Elan Patents
under Clause 2, HepaSense shall pay to Elan a non-refundable license fee
of US [ * ] (the "LICENSE FEE"), the receipt of which is hereby
acknowledged by Elan.
The License Fee shall not be subject to future performance obligations
of Elan to HepaSense or Isis and shall not be applicable against future
services provided by Elan to HepaSense or Isis. The license fee terms as
set out in Clause 5.1 of this Agreement are independent and distinct
from the other terms of this Agreement.
5.2 MILESTONE AND ROYALTY PAYMENTS RELATING TO PRODUCTS: All net proceeds
derived by HepaSense from the Product shall be allocated as additional
royalties in proportion to [ * ], as more particularly set forth below.
(a) Milestone Payments - If any third party shall make
milestone payments (e.g., for NDA filing, approvals, etc.) to
HepaSense, HepaSense shall pay to Elan and Isis an additional royalty
in the amount of such milestone payments [ * ].
(b) Royalties payable to Elan and Isis Upon sales of the
Product - Elan and Isis shall receive royalties based on In-market
Net Sales of the Product aggregating [ * ] for sales directly by
HepaSense or its sublicensees or such other royalty as the Parties
may negotiate.
5.3 MILESTONE AND ROYALTY PAYMENTS RELATING TO ADDITIONAL PRODUCTS: All net
proceeds derived by HepaSense from Additional Products shall be
allocated as additional royalties [ * ], as more particularly set forth
below. Elan, Isis and HepaSense shall negotiate separate royalty
payments for Elan (including, without limitation, participation by
HepaSense and Elan in milestone payments made by independent third
parties to Isis) for any Additional Products at commercially reasonable
rates on arms length terms between unrelated parties; provided, however,
that HepaSense or Isis, as the case may be, shall not be obligated for
the payment of an additional one-time access license fee.
5.4 Payment of royalties pursuant to Clause 5.3 shall be made quarterly in
arrears during each Financial Year within 50 days after the expiry of
the calendar quarter. The method of payment shall be by wire transfer to
an account specified by Elan. Each payment made to Elan shall be
accompanied by a true accounting of all Products sold by HepaSense's
permitted sublicensees, if any, during such quarter.
Such accounting shall show, on a country-by-country and
Product-by-Product basis, Net Sales (and the calculation thereof) and
each calculation of royalties with respect
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thereto, including the calculation of all adjustments and currency
conversions.
Any royalties, license fees or other payments due under this Agreement
to Elan shall be apportioned in accordance with a formula agreed between
Elan, plc and EPIL.
5.5 HepaSense shall maintain and keep clear, detailed, complete, accurate
and separate records for a period of 3 years:
5.5.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.5.2 to enable any deductions made in the Net Sales calculation to be
determined.
5.6 All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product for each calendar quarter made
in a currency other than United States Dollars shall first be calculated
in the foreign currency and then converted to United States Dollars on
the basis of the exchange rate in effect on the last working day for
such quarter for the purchase of United States Dollars with such foreign
currency quoted in the Wall Street Journal (or comparable publication if
not quoted in the Wall Street Journal) with respect to the currency of
the country of origin of such payment, determined by averaging the rates
so quoted on each business day of such quarter.
5.7 If, at any time, legal restrictions in the Territory prevent the prompt
payment when due of royalties or any portion thereof, the Parties shall
meet to discuss suitable and reasonable alternative methods of paying
Elan the amount of such royalties. In the event that HepaSense is
prevented from making any payment under this Agreement by virtue of the
statutes, laws, codes or government regulations of the country from
which the payment is to be made, then such payments may be paid by
depositing them in the currency in which they accrue to Elan's account
in a bank acceptable to Elan in the country the currency of which is
involved or as otherwise agreed by the Parties.
5.8 Elan and HepaSense agree to co-operate in all respects necessary to take
advantage of any double taxation agreements or similar agreements as
may, from time to time, be available.
5.9 Any taxes payable by Elan on any payment made to Elan pursuant to this
Agreement shall be for the account of Elan. If so required by applicable
law, any payment made pursuant to this Agreement shall be made by
HepaSense after deduction of the appropriate withholding tax, in which
event the Parties shall co-operate to obtain the appropriate tax
clearance as soon as is practicable. On receipt of such clearance,
HepaSense shall forthwith arrange payment to Elan of the amount so
withheld.
6 RIGHT OF INSPECTION AND AUDIT
6.1 Once during each Financial Year, or more often not to exceed quarterly
as reasonably requested by Elan, HepaSense shall permit Elan or its duly
authorised representatives,
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upon reasonable notice and at any reasonable time during normal business
hours, to have access to inspect and audit the accounts and records of
HepaSense and any other book, record, voucher, receipt or invoice
relating to the calculation of the royalty payments on Net Sales
submitted to Elan.
Any such inspection of HepaSense's records shall be at the expense of
Elan, except that if any such inspection reveals a deficiency in the
amount of the royalty actually paid to Elan hereunder in any Financial
Year quarter of 5% or more of the amount of any royalty actually due to
Elan hereunder, then the expense of such inspection shall be borne
solely by HepaSense. Any amount of deficiency shall be paid promptly to
Elan by HepaSense.
If such inspection reveals a surplus in the amount of royalties actually
paid to Elan by HepaSense, Elan shall reimburse HepaSense the surplus
within 15 days after determination.
6.2 In the event of any unresolved dispute regarding any alleged deficiency
or overpayment of royalty payments hereunder, the matter will be
referred to an independent firm of chartered accountants chosen by
agreement of Isis and Elan for a resolution of such dispute. Any
decision by the said firm of chartered accountants shall be binding on
the Parties.
7 REPRESENTATIONS AND WARRANTIES
7.1 Elan represents and warrants to HepaSense and Isis as of the Effective
Date that, except as set forth on Schedule 3 hereto:
7.1.1 Elan has the right to grant the Elan License;
7.1.2 there are no agreements between Elan and any third party that
conflict with the Elan License;
7.1.3 the patents and patent applications included in the Elan Patents
are free and clear of encumbrances and liens;
7.1.4 to the best of Elan's knowledge, there are no proceedings
pending or threatened against Elan in connection with the Elan
Intellectual Property in relation to the Field; and
7.1.5 the Elan Intellectual Property constitutes all intellectual
property owned or licensed by Elan that is reasonably applicable
to the Project as it relates to the System.
7.2 In addition to any other indemnities provided for herein, Elan shall
indemnify and hold harmless HepaSense and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages
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(including reasonable attorney's fees and expenses) incurred or
sustained by HepaSense arising out of or in connection with any:
7.2.1 breach of any representation, covenant, warranty or obligation
by Elan hereunder; or
7.2.2 act or omission on the part of Elan or any of its respective
employees, agents, officers and directors in the performance of
this Agreement.
7.3 In addition to any other indemnities provided for herein, HepaSense
shall indemnify and hold harmless Elan and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Elan arising out
of or in connection with any:
7.3.1 breach of any representation, covenant, warranty or obligation
by HepaSense hereunder; or
7.3.2 act or omission on the part of HepaSense or any of its agents or
employees in the performance of this Agreement.
7.4 The Party seeking an indemnity shall:
7.4.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
7.4.2 permit the indemnifying Party to take full care and control of
such claim or proceeding;
7.4.3 co-operate in the investigation and defence of such claim or
proceeding;
7.4.4 not compromise or otherwise settle any such claim or proceeding
without the prior written consent of the other Party, which
consent shall not be unreasonably withheld conditioned or
delayed; and
7.4.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.5 EXCEPT AS SET FORTH IN THIS CLAUSE 7, ELAN IS GRANTING THE LICENSES
HEREUNDER ON AN "AS IS" BASIS WITHOUT REPRESENTATION OR WARRANTY WHETHER
EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL
SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.
7.6 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND
HEPASENSE SHALL NOT BE LIABLE TO THE
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OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER
TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS
AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS
OR DAMAGE (WHETHER FOR LOSS OF PROFITS OR OTHERWISE) AND WHETHER
OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES
OR AGENTS OR OTHERWISE.
8. TERM AND TERMINATION
8.1 On a product by product basis, subject to the provisions of Clause 10
and 11, the term of the Licenses granted hereunder with respect to a
Product and/or Additional Product in each country in the Territory (the
"TERM") shall be the greater of:
8.1.1 [ * ] years from the date of the first commercial sale of the
Product or Additional Products; or
8.1.2 the life of the patent rights utilized in the Product or
Additional Products or upon which the Product or Additional
Product is based.
8.2 If either Party commits a Relevant Event, the other Party shall have, in
addition to all other legal and equitable rights and remedies hereunder,
the right to terminate this Agreement upon 30 days' prior written notice
to the defaulting Party.
8.3 For the purpose of this Clause 8, a "RELEVANT EVENT" is committed or
suffered by a Party if:
8.3.1 it commits a material breach of its obligations under this
Agreement or the JDOA and such breach (i) is not capable of
being cured or (ii) is capable of being cured the breaching
Party fails to remedy it within 60 days of being specifically
required in writing to do so by the other Party; provided, that
if the breaching Party has proposed a course of action to
rectify the breach and is acting in good faith to rectify same
but has not cured the breach by the 60th day, such period shall
be extended by such period as is reasonably necessary to permit
the breach to be rectified;
8.3.2 a distress, execution, sequestration or other process is levied
or enforced upon or sued out against a material part of its
property which is not discharged or challenged within 30 days;
8.3.3 it is unable to pay its debts in the normal course of business;
8.3.4 it ceases wholly or substantially to carry on its business,
otherwise than for the purpose of a reconstruction or
amalgamation, without the prior written consent of the other
Party (such consent not to be unreasonably withheld);
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*CONFIDENTIAL TREATMENT REQUESTED
17
8.3.5 the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Party or over all
or substantially all of its assets under the law of any
applicable jurisdiction, including without limitation, the
United States of America, Bermuda or Ireland;
8.3.6 an application or petition for bankruptcy, corporate
re-organisation, composition, administration, examination,
arrangement or any other procedure similar to any of the
foregoing under the law of any applicable jurisdiction,
including without limitation, the United States of America,
Bermuda or Ireland, is filed, and is not discharged within 60
days, or a Party applies for or consents to the appointment of a
receiver, administrator, examiner or similar officer of it or of
all or a material part of its assets, rights or revenues or the
assets and/or the business of a Party are for any reason seized,
confiscated or condemned.
8.4 In the event that a Competitive Change of Control Event shall occur, at
the sole option of Elan and upon written notice to Isis and HepaSense,
the Elan License shall be immediately terminated. Upon written notice
from Isis to Elan of a proposed Competitive Change of Control Event or
the occurrence of a Competitive Change of Control Event, Elan shall have
thirty (30) days from such notice to Isis to provide written notice to
Isis as to whether it intends to terminate the Elan License. In the
event Elan does not provide written notice to Isis during such thirty
(30) day period of its intention to terminate the Elan License, such
termination right shall be deemed waived with respect to such
occurrence.
8.5 Upon expiration or termination of the Agreement:
8.5.1. any sums that were due from HepaSense to Elan on Net Sales in
the Territory or in such particular country or countries in the
Territory (as the case may be) prior to the expiration or
termination of this Agreement as set forth herein shall be paid
in full within 60 days after the expiration or termination of
this Agreement for the Territory or for such particular country
or countries in the Territory (as the case may be);
8.5.2 any provisions that expressly survive termination or expiration
of this Agreement, including without limitation this Clause 8,
shall remain in full force and effect;
8.5.3 all representations, warranties and indemnities shall insofar as
are appropriate remain in full force and effect;
8.5.4 the rights of inspection and audit set out in Clause 6 shall
continue in force for a period of one year; and
8.5.5 all rights and licenses granted pursuant to this Agreement and
to the Elan Intellectual Property pursuant to the JDOA
(including the rights of HepaSense pursuant to Clause 11 of the
JDOA) shall cease for the Territory or for such particular
country or countries in the Territory (as the case may be) and
shall
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revert to or be transferred to Elan, and HepaSense shall not
thereafter use in the Territory or in such particular country or
countries in the Territory (as the case may be) any rights
covered by this Agreement;
8.5.6 subject to Clause 8.5.7 and to such license, if any, granted by
HepaSense to Elan pursuant to the provisions of Clause 10 of the
JDOA, all rights to HepaSense Intellectual Property shall be
transferred to and jointly owned by Isis and Elan but may not be
exploited by both Elan and Isis, unless otherwise agreed by the
unanimous vote of the Management Committee, and may only be
exploited by either Elan and Isis pursuant to written consent
from the other Party.
In the event of a dispute arising pursuant to this Clause 8.5.6,
Elan and Isis agree to negotiate in good faith on the course of
action to be taken with respect to determining their respective
entitlements pursuant to this Clause 8.5.6; and
8.5.7 the rights of permitted third party sub-licensees in and to the
Elan Intellectual Property shall survive the termination of the
license and sublicense agreements granting said intellectual
property rights to HepaSense; and HepaSense, Elan and Isis shall
in good faith agree upon the form most advantageous to Elan and
Isis in which the rights of HepaSense under any such licenses
and sublicenses are to be held (which form may include
continuation of HepaSense solely as the holder of such licenses
or assignment of such rights to a third party or parties,
including an assignment to both Elan and Isis).
Any sublicense agreement between HepaSense and such permitted
sublicensee shall permit an assignment of rights by HepaSense
and shall contain appropriate confidentiality provisions.
9 CONFIDENTIAL INFORMATION
9.1 The Parties agree that it will be necessary, from time to time, to
disclose to each other confidential and proprietary information,
including without limitation, inventions, works of authorship, trade
secrets, specifications, designs, data, know-how and other proprietary
information relating to the Field, the Products, processes, services and
business of the disclosing Party.
The foregoing shall be referred to collectively as "CONFIDENTIAL
INFORMATION".
9.2 Any Confidential Information disclosed by one Party to another Party
shall be used by the receiving Party exclusively for the purposes of
fulfilling the receiving Party's obligations under this Agreement and
the JDOA and for no other purpose.
9.3 Each Party shall disclose Confidential Information of the other Party
only to those employees, representatives and agents requiring knowledge
thereof in connection with fulfilling the Party's obligations under this
Agreement. Each Party further agrees to inform all such employees,
representatives and agents of the terms and provisions of
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this Agreement and their duties hereunder and to obtain their agreement
hereto as a condition of receiving Confidential Information. Each Party
shall exercise the same standard of care as it would itself exercise in
relation to its own confidential information (but in no event less than
a reasonable standard of care) to protect and preserve the proprietary
and confidential nature of the Confidential Information disclosed to it
by the other Party. Each Party shall, upon request of the other Party,
return all documents and any copies thereof containing Confidential
Information belonging to, or disclosed by, such other Party.
9.4 Any breach of this Clause 9 by any person informed by one of the Parties
is considered a breach by the Party itself.
9.5 Confidential Information shall not be deemed to include:
9.5.1 information that is in the public domain;
9.5.2 information which is made public through no breach of this
Agreement;
9.5.3 information which is independently developed by a Party as
evidenced by such Party's records;
9.5.4 information that becomes available to a Party on a
non-confidential basis, whether directly or indirectly, from a
source other than a Party, which source did not acquire this
information on a confidential basis; or
9.5.5 information which the receiving Party is required to disclose
pursuant to:
(i) a valid order of a court or other governmental body; or
(ii) any other requirement of law;
provided that if the receiving Party becomes legally required to
disclose any Confidential Information, the receiving Party shall
give the disclosing Party prompt notice of such fact so that the
disclosing Party may obtain a protective order or other
appropriate remedy concerning any such disclosure. The receiving
Party shall fully co-operate with the disclosing Party in
connection with the disclosing Party's efforts to obtain any
such order or other remedy. If any such order or other remedy
does not fully preclude disclosure, the receiving Party shall
make such disclosure only to the extent that such disclosure is
legally required.
9.6 The provisions relating to confidentiality in this Clause 9 shall remain
in effect during the term of this Agreement, and for a period of 7 years
following the expiration or earlier termination of this Agreement.
9.7 The Parties agree that the obligations of this Clause 9 are necessary
and reasonable in order to protect the Parties' respective businesses,
and each Party agrees that monetary damages would be inadequate to
compensate a Party for any breach by the
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other Party of its covenants and agreements set forth herein.
Accordingly, the Parties agree that any such violation or threatened
violation shall cause irreparable injury to a Party and that, in
addition to any other remedies that may be available, in law and equity
or otherwise, each Party shall be entitled to obtain injunctive relief
against the threatened breach of the provisions of this Clause 9, or a
continuation of any such breach by the other Party, specific performance
and other equitable relief to redress such breach together with its
damages and reasonable counsel fees and expenses to enforce its rights
hereunder, without the necessity of proving actual or express damages.
9.8 For the avoidance of doubt, all Confidential Information of HepaSense
received by Elan hereunder shall not be disclosed by Elan to its
Affiliates and/or subsidiaries (present or future) within the division
of Elan Pharmaceuticals Corporation, plc. carrying on business as Elan
Pharmaceuticals (which incorporates, inter alia, Athena Neurosciences,
Inc., Elan Pharmaceuticals, Inc., Elan Diagnostics, Carnrick
Laboratories, and Elan Europe Limited) and Targon Corporation.
10 GOVERNING LAW AND DISPUTE RESOLUTION
10.1 This Agreement shall be governed by and construed in accordance with the
laws of the State of New York without regard to principles relating to
conflicts of laws.
10.2 The Parties will attempt in good faith to resolve any dispute arising
out of or relating to this Agreement promptly by negotiation between
executives of the Parties. In the event that such negotiations do not
result in a mutually acceptable resolution, the Parties agree to
consider other dispute resolution mechanisms including mediation.
10.3 Any dispute under this Agreement which is not settled by mutual consent
under Clause 10.2 will be subject to resolution in accordance with
Clauses 19 and 24.8 of the JDOA, which is incorporated by reference and
shall for such purposes survive termination of the JDOA.
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Elan nor HepaSense shall be liable for delay in the performance
of any of its obligations hereunder if such delay results from causes
beyond its reasonable control, including, without limitation, acts of
God, fires, strikes, acts of war, intervention of a government
authority, but any such delay or failure shall be remedied by such Party
as soon as practicable.
12 ASSIGNMENT
This Agreement may not be assigned by either Party without the prior
written consent of the other, save that either Party may assign this
Agreement to its Affiliates or subsidiaries without such prior written
consent [and that Elan may assign this Agreement to any off-balance
sheet special purpose entity established by Elan or EIS without such
prior written consent;] provided that such assignment does not have any
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adverse tax consequences on the other Party.
13 NOTICES
13.1 Any notice to be given under this Agreement shall be sent in writing in
English by registered airmail or telefaxed to the following addresses:
If to HepaSense at:
000 Xx. Xxxxx Xxxxx
Xxxxxxxxx House
Church St.
Hamilton, Bermuda
Attention: Secretary
Telephone: 000-000-0000
Fax: 000-000-0000
with a copy to Elan, plc and EPIL at:
Elan Corporation, plc
Elan Pharma International Limited
c/o Elan International Services, Ltd.
000 Xx. Xxxxx Xxxxx
Xxxxxx,
Xxxxxx XX00
Bermuda
Attention: Secretary
Telephone: 000 000 0000
Fax: 000 000 0000
with a copy to:
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: B. Xxxxx Xxxxxxxx, Esq.
Telephone: (000) 000-0000
Telefax: (000) 000-0000
If to Isis at:
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: B. Xxxxx Xxxxxxxx, Esq.
Telephone: (000) 000-0000
Telefax: (000) 000-0000
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If to Elan, plc and/or EPIL at:
Elan Corporation, plc
Elan Pharma International Limited
C/o Elan International Services, Ltd.
000 Xx. Xxxxx Xxxxx
Xxxxxx,
Xxxxxx XX00
Bermuda
Attention: Secretary
Telephone: 000 000 0000
Fax: 000 000 0000
or to such other address(es) and telefax numbers as may from time to
time be notified by either Party to the other hereunder.
13.2 Any notice sent by mail shall be deemed to have been delivered within
seven 7 working days after dispatch and any notice sent by telex or
telefax shall be deemed to have been delivered within twenty 24 hours of
the time of the dispatch. Notice of change of address shall be effective
upon receipt.
14 MISCELLANEOUS
14.1 WAIVER:
No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the Party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any other breach or failure to perform or of
any other right arising under this Agreement.
14.2 SEVERABILITY:
If any provision in this Agreement is agreed by the Parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under
any law that is applicable hereto:
14.2.1 such provision will be deemed amended to conform to applicable
laws so as to be valid and enforceable; or
14.2.2 if it cannot be so amended without materially altering the
intention of the Parties, it will be deleted, with effect from
the date of such agreement or such earlier date as the Parties
may agree, and the validity, legality and enforceability of the
remaining provisions of this Agreement shall not be impaired or
affected in any way.
14.3 FURTHER ASSURANCES:
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At the request of any of the Parties, the other Party or Parties shall
(and shall use reasonable efforts to procure that any other necessary
parties shall) execute and perform 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.
14.4 SUCCESSORS:
This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns.
14.5 NO EFFECT ON OTHER AGREEMENTS/CONFLICT:
No provision of this Agreement shall be construed so as to negate,
modify or affect in any way the provisions of any other agreement
between the Parties unless specifically referred to, and solely to the
extent provided herein.
In the event of a conflict between the provisions of this Agreement and
the provisions of the JDOA, the terms of the JDOA shall prevail unless
this Agreement specifically provides otherwise.
14.6 AMENDMENTS:
No amendment, modification or addition hereto shall be effective or
binding on any Party unless set forth in writing and executed by a duly
authorised representative of each Party.
14.7 COUNTERPARTS:
This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of
which when taken together shall constitute this Agreement.
14.8 GOOD FAITH:
Each Party undertakes to do all things reasonably within its power which
are necessary or desirable to give effect to the spirit and intent of
this Agreement.
14.9 NO RELIANCE:
Each Party hereby acknowledges that in entering into this Agreement it
has not relied on any representation or warranty save as expressly set
out herein or in any document referred to herein.
14.10 RELATIONSHIP OF THE PARTIES:
Nothing contained in this Agreement is intended or is to be construed to
constitute
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Elan and HepaSense as partners, or Elan as an employee of HepaSense, or
HepaSense as an employee of Elan.
Neither Party hereto shall have any express or implied right or
authority to assume or create any obligations on behalf of or in the
name of the other Party or to bind the other Party to any contract,
agreement or undertaking with any third party.
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IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED BY:
-------------------------
for and on behalf of
ELAN CORPORATION, PLC ACTING
THROUGH ITS DIVISION ELAN
PHARMACEUTICAL TECHNOLOGIES
SIGNED BY:
-------------------------
for and on behalf of
ELAN PHARMA INTERNATIONAL LIMITED
SIGNED BY:
-------------------------
For and on behalf of
HEPASENSE LTD.
AGREED TO AND ACCEPTED BY
SIGNED BY:
-------------------------
For and on behalf of ISIS PHARMACEUTICAL, INC.
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SCHEDULE 1
ELAN PATENTS
CONTINUOUS SYSTEM
----------------------------------------------------------------------------------------------------------
FILE NUMBER BRIEF DESCRIPTION COUNTRY STATUS
----------------------------------------------------------------------------------------------------------
EMT 13 Original System Australia Granted (693136)
Canada Pending
EP Pending
Israel Granted (111685)
Japan Pending
New Zealand Granted (276485)
Taiwan Granted (079227)
United States 2 Granted (5,527,288;
5,848,991); 0 Xxxxxxx
Xxxxx Xxxxxx Granted (94/9185)
----------------------------------------------------------------------------------------------------------
EMT 19 Medipad-Vial on board, needle on the Australia Pending
periphery Canada Pending
EP Pending
Ireland Granted (77523)
Japan Pending
Mexico Pending
New Zealand Pending
Norway Pending
Taiwan Pending
United States Granted (5,814,020)
South Korea Pending
South Africa Granted (96/7502)
----------------------------------------------------------------------------------------------------------
EMT 24 Delivery Needle Australia Pending
Canada Canada
EP Pending
Ireland Granted (80772)
Israel Pending
Japan Pending
New Zealand Pending
South Africa Granted (97/5065)
Xxxxx Xxxxx Xxxxxxx
Xxxxxx Xxxxxx (000000)
Xxxxxx Xxxxxx Pending
----------------------------------------------------------------------------------------------------------
EMT 29 Improved Medipad & Filling System PCT Pending
(pressure adjustmt. valve, 3-position Argentina Pending
needle) Ireland Pending
Taiwan Pending
United States Pending
----------------------------------------------------------------------------------------------------------
EMT 33 Improved Method of Packaging a Drug PCT Pending
----------------------------------------------------------------------------------------------------------
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----------------------------------------------------------------------------------------------------------
Delivery Kit Ireland Pending
South Africa Issued (98/5188)
Taiwan Pending
United States Pending
----------------------------------------------------------------------------------------------------------
EMT 36 Improved Adhesive System for a Medical PCT Pending
Device Taiwan Pending
United States Pending
----------------------------------------------------------------------------------------------------------
EMT41DES Design of Medipad Housing (3ml) United States Granted (D404482)
----------------------------------------------------------------------------------------------------------
EMT 45 Liquid Drug Container United States Pending
----------------------------------------------------------------------------------------------------------
All countries are initially designated when filing in the European Patent Office
or the Patent Cooperation Treaty, and are then selected during the regional or
national phase.
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SCHEDULE 2A
PRIMARY TECHNOLOGICAL COMPETITORS OF ELAN(1)
[ * ]
SCHEDULE 2B
TECHNOLOGICAL COMPETITORS OF ELAN(1)
[ * ]
----------
1. Including any and all divisions or subsidiaries of the above.
28
*CONFIDENTIAL TREATMENT REQUESTED
29
SCHEDULE 3
ELAN EXCEPTIONS AND DISCLOSURES
[ * .]
29
*CONFIDENTIAL TREATMENT REQUESTED
