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EXHIBIT 10.8
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
ISIS PHARMACEUTICALS, INC.
AND
HEPASENSE LTD.
JANUARY 14, 2000
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TABLE OF CONTENTS
1 DEFINITIONS
2 ISIS 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 day of January 2000
BETWEEN:
(1) 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; and
(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) 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;
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 Isis so as to permit
HepaSense to utilize the Isis 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 Elan are entering into the Elan
License Agreement relating to HepaSense's use of the Elan 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 Additional Oligonucleotide and incorporated within or
packaged with the System.
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"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.
"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 have the meaning as such term is defined in
the Elan License Agreement.
"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 have the meaning as such term is defined in the
Elan
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License Agreement.
"ELAN LICENSE" shall have the meaning set forth in Clause 2.1 of the
Elan License Agreement.
"ELAN LICENSE AGREEMENT" shall mean that certain license agreement, of
even date herewith, entered into between Elan and HepaSense.
"ELAN PATENTS" shall have the meaning as such term is defined in the
Elan License Agreement.
"EPIL" shall mean Elan Pharma International Limited, a private limited
company incorporated under the laws of Ireland, that is wholly owned by
Elan, plc.
"EXISTING ISIS LICENSE AGREEMENTS" shall mean the following agreements:
(a) Amended License Agreement, between Public Health Service and
Gen-Probe, Incorporated, as amended by the Second License Agreement
between Public Health Service and Gen-Probe, Incorporated, (b) the
Settlement Agreement among Public Health Service, Gen-Probe,
Incorporated and Genta Incorporated and (c) Asset Purchase Agreement,
effective as of December 19, 1997 between Gen-Probe, Incorporated and
Isis.
Notwithstanding anything contained herein to the contrary, nothing
contained in this License Agreement shall be deemed to constitute an
admission by Isis that any of the Isis Intellectual Property is subject
to or governed by any of the Existing Isis License Agreements.
"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
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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
or a sub-licensee.
"ISIS" shall mean Isis Pharmaceuticals, Inc. and its Affiliates,
excluding HepaSense.
"ISIS IMPROVEMENTS" shall mean improvements to the Isis Patents and/or
the Isis Know-How developed (i) by Isis whether or not pursuant to the
Project, (ii) by HepaSense or Elan or by a third party (under contract
with HepaSense) pursuant to the Project, and/or (iii) jointly by any
combination of Isis, Elan or HepaSense pursuant to the Project, except
as limited by agreements with third parties.
Subject to third party agreements, Isis Improvements shall constitute
part of Isis Intellectual Property and be included in the license of the
Isis Intellectual Property pursuant to Clause 2.1 solely for the
purposes set forth therein. If the inclusion of a Isis Improvement in
the license of Isis Intellectual Property is restricted or limited by a
third party agreement, Isis shall use reasonable commercial efforts to
minimize any such restriction or limitation.
"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 KNOW-HOW" shall mean any and all rights owned, licensed or
controlled by Isis to any scientific, pharmaceutical or technical
information, data, discovery, invention (whether patentable or not),
technique, process, procedure, system, formulation or design relating to
the Designated Oligonucleotide that is not generally known to the
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public.
"ISIS LICENSE" shall mean have the meaning set forth in Clause 2.1
hereof.
"ISIS 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 Isis containing claims relating to the Designated
Oligonucleotide. Upon nomination and approval of an Additional
Oligonucleotide, Schedule 1 shall be amended to include any and all
patents and patent applications 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 Isis containing claims relating to the Additional
Oligonucleotide.
"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
hereto.
"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 compassionate programs
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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 Isis or HepaSense, as the case may be, and "PARTIES"
shall mean Isis and HepaSense.
"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.
"SUBSTITUTE OLIGONUCLEOTIDE" shall have the meaning set forth in Clause
2.2 hereof;
"SYSTEM" shall have the meaning as such term is defined in the Elan
License Agreement.
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"TECHNOLOGICAL COMPETITOR OF ISIS" shall mean a company, corporation or
person listed in Schedule 2 and successors thereof or any additional
broad-based technological competitor of Isis 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 ISIS LICENSE TO HEPASENSE
2.1 Isis hereby grants to Newco for the Term an exclusive license (including
the limited right to grant sublicenses under Clause 10 of the JDOA) (the
"ISIS License") to the Isis 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 Isis has as of
the Effective Date. 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 Isis Intellectual Property for use with the Additional
Oligonucleotide or (ii) the terms for amendment of the Isis License to
include the license of the Isis 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 Isis has as of the date of
such agreement.
2.2 Isis hereby confirms that no obligations are in effect on the date
hereof between Isis and an unaffiliated third party relating to the
Designated Oligonucleotide for use in the Field, other than the Existing
Isis License Agreements.
Isis shall be responsible for payments related to the financial
provisions and
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obligations under the Existing Isis License Agreements (including
amendments thereto), including, without limitation, any royalty or other
compensation obligations.
2.3 Subject to the provisions of Clause 2.2, to the extent royalty or other
compensation obligations are payable to third parties with respect to
Isis Intellectual Property would be triggered by use of such Isis
Intellectual Property in connection with the Project, Isis shall inform
Elan of such royalty or compensation obligation. If HepaSense and Elan
agree to utilize such Isis Intellectual Property in connection with the
Project, HepaSense shall be responsible for the payment of such royalty
or other compensation obligations relating thereto.
2.4 Elan shall have the right to cause HepaSense to enforce HepaSense's
rights under this Agreement against Isis.
2.5 Notwithstanding anything contained in this Agreement to the contrary,
Isis 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 Isis Intellectual Property.
For the avoidance of doubt, HepaSense shall have no right to use the
Isis Intellectual Property outside the Field.
2.6 Except as provided in Clause 11 in the JDOA, HepaSense shall not be
permitted to assign, license or sublicense any of its rights under the
Isis Intellectual Property and/or the HepaSense Intellectual Property
without the prior written consent of Isis.
2.7 Any agreement between HepaSense and any permitted third party for the
development or exploitation of the Isis Intellectual Property shall
require such third party to maintain the confidentiality of all
information concerning the Isis Intellectual Property and shall provide
that any Isis Improvements shall belong to Isis and shall permit an
assignment of rights by HepaSense to Isis in accordance with the terms
of this Agreement.
Insofar as the obligations owed by HepaSense to Isis 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
3.1 OWNERSHIP OF INTELLECTUAL PROPERTY:
3.1.1 HepaSense shall own the HepaSense Intellectual Property.
3.1.2 Isis shall own the Isis Intellectual Property.
4 NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
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4.1 Subject to Clause 4.2 hereof and Clause 13 of the JDOA, during the [ * ]
year period commencing on the effective date, Isis, alone or in
conjunction with a third party, shall not develop or commercialize (i)
any Oligonucleotide for the treatment of HCV or (ii) the Designated
Oligonucleotide for the treatment of HCV or any other indication.
4.2 If after the Effective Date Isis acquires know-how or patent rights from
a third party relating to the Isis Intellectual Property, or if Isis
acquires or merges with a third party entity that owns or has license
rights to know-how or patent rights relating to the Isis Intellectual
Property, then Isis shall offer to license such know-how and patent
rights to HepaSense (subject to existing contractual obligations) solely
for HepaSense to research, develop and otherwise engage in the
commercialization of the Product solely for use in the Field on such
terms as would be offered to an independent third party negotiating in
good faith on an arms-length basis.
If HepaSense determines that HepaSense should not acquire such license,
Isis shall be free to fully exploit such know-how and patent rights with
the Isis 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
5.1 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.
5.2 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
* CONFIDENTIAL TREATMENT REQUESTED
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an additional one-time access license fee.
5.3 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 Isis. Each payment made to Isis 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 thereto, including the
calculation of all adjustments and currency conversions.
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
Isis 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 Isis's account
in a bank acceptable to Isis in the country the currency of which is
involved or as otherwise agreed by the Parties.
5.8 Isis 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 Isis on any payment made to Isis pursuant to this
Agreement shall be for the account of Isis. 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,
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HepaSense shall forthwith arrange payment to Isis 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 Isis, HepaSense shall permit Isis or its duly
authorised representatives, 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 Isis.
Any such inspection of HepaSense's records shall be at the expense of
Isis, except that if any such inspection reveals a deficiency in the
amount of the royalty actually paid to Isis hereunder in any Financial
Year quarter of 5% or more of the amount of any royalty actually due to
Isis hereunder, then the expense of such inspection shall be borne
solely by HepaSense. Any amount of deficiency shall be paid promptly to
Isis by HepaSense.
If such inspection reveals a surplus in the amount of royalties actually
paid to Isis 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 Isis represents and warrants to HepaSense and Elan as of the Effective
Date that:
7.1.1 Isis has the right to grant the Isis License;
7.1.2 there are no agreements between Isis and any third party that
conflict with the Isis License;
7.1.3 the patents and patent applications included in the Isis Patents
are free and clear of encumbrances and liens except for any
license which would not preclude Isis from granting the licenses
granted hereunder;
7.1.4 to the best of Isis's knowledge, there are no proceedings
pending or threatened against Isis in connection with the Isis
Intellectual Property in relation to the Field; and
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7.1.5 the Isis Intellectual Property constitutes all intellectual
property owned or licensed by Isis that is reasonably applicable
to the Project as it relates to the Designated Oligonucleotide.
7.2 Isis shall not amend, modify, waive or terminate any of its rights under
any Existing Isis License Agreement without the prior written consent of
the Management Committee (by the unanimous vote of its members);
provided, however, that such consent will be required only if such
amendment, modification, waiver or termination would have an adverse
effect, individually or in the aggregate, on the financial condition,
prospects, results of operation, business, and/or assets (including,
without limitation, the Licensed Technologies, and/or the HepaSense
Intellectual Property) of HepaSense.
7.3 Isis agrees and represents and warrants to HepaSense and Elan as
follows: (i) the Existing Isis License Agreements are valid and in full
force and effect, (ii) there are no existing or claimed defaults by
Isis, and to Isis's knowledge by any other party, under the Existing
Isis License Agreements; and no event, act or omission has occurred
which (with or without notice, lapse of time or the happening or
occurrence of any other event) would result in a default under the
Existing Isis License Agreements by Isis, or to Isis's knowledge by any
other party, and (iii) Isis shall during the term of the Licenses, fully
comply with all terms and conditions of the Existing Isis License
Agreements; Isis will enforce its rights under the Existing Isis License
Agreements, as they relate to the Designated Oligonucleotide; and Isis
will not assign its rights under the Existing Isis License Agreements,
as they relate the Designated Oligonucleotide. Isis will keep HepaSense
and Elan fully informed with respect to Isis's arrangements under the
Existing Isis License Agreements that relate to HepaSense and/or the
transactions contemplated hereunder. Isis shall provide HepaSense and
Elan with any written notices delivered by any party under the Existing
Isis License Agreements, which written notices relate to or could affect
HepaSense and/or the transactions contemplated hereunder.
7.4 In addition to any other indemnities provided for herein, Isis 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 (including reasonable
attorney's fees and expenses) incurred or sustained by HepaSense arising
out of or in connection with any:
7.4.1 breach of any representation, covenant, warranty or obligation
by Isis hereunder; or
7.4.2 act or omission on the part of Isis or any of its respective
employees, agents, officers and directors in the performance of
this Agreement.
7.5 In addition to any other indemnities provided for herein, HepaSense
shall indemnify and hold harmless Isis 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 Isis arising out
of or in connection with any:
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7.5.1 breach of any representation, covenant, warranty or obligation
by HepaSense hereunder; or
7.5.2 act or omission on the part of HepaSense or any of its agents or
employees in the performance of this Agreement.
7.6 The Party seeking an indemnity shall:
7.6.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
7.6.2 permit the indemnifying Party to take full care and control of
such claim or proceeding;
7.6.3 co-operate in the investigation and defence of such claim or
proceeding;
7.6.4 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
7.6.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.7 EXCEPT AS SET FORTH IN THIS CLAUSE 7, ISIS 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.
7.8 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ISIS AND
HEPASENSE SHALL NOT BE LIABLE TO THE 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
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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);
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 or Bermuda; or
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.
* CONFIDENTIAL TREATMENT REQUESTED
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8.4 Upon expiration or termination of the Agreement:
8.4.1 any sums that were due from HepaSense to Isis 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);
8.4.2 any provisions that expressly survive termination or expiration
of this Agreement, including without limitation this Clause 8,
shall remain in full force and effect;
8.4.3 all representations, warranties and indemnities shall insofar as
are appropriate remain in full force and effect;
8.4.4 the rights of inspection and audit set out in Clause 6 shall
continue in force for a period of one year; and
8.4.5 all rights and licenses granted pursuant to this Agreement and
to the Isis 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 revert to or be transferred to Isis, 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;
8.4.6 subject to Clause 8.4.7 and to such license, if any, granted by
HepaSense to Isis 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 8.4.6,
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 8.4.6.
8.4.7 the rights of permitted third party sub-licensees in and to the
Isis 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
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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 this Clause 9
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
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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 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.
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 are incorporated by reference and
shall for such purposes survive
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termination of the JDOA
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Isis 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; provided that such assignment does not have any 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
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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
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.
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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:
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
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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 Isis and HepaSense as partners, or Isis as an employee of
HepaSense, or HepaSense as an employee of Isis.
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
ISIS PHARMACEUTICAL, INC.
SIGNED BY:____________________
For and on behalf of
HEPASENSE LTD.
AGREED TO AND ACCEPTED BY
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
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EXHIBIT A
DESCRIPTION OF ISIS 14803
[ * ].
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* CONFIDENTIAL TREATMENT REQUESTED
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SCHEDULE 1
ISIS PATENTS
The following US patent applications are directed to antisense inhibition of
Hepatitis C virus and have claims whose scope includes the ISIS 14803 compound,
either broadly or specifically:
DOCKET NO. APPL. NO. FILE DATE STATUS
DOC-0002 PCT/JP 93/01293 entered national phase
ISPH-0031 US 08/397,220 pending
ISPH-0136 US 08/452,841 pending
ISPH-0138 US 08/453,085 abandoned
ISPH-0145 US 08/650,093 pending
ISPH-0203 US 08/823,895 pending
ISPH-0245 US 08/988,321 pending
ISPH-0335 PCT/US 98/26040 international phase
ISIS Manufacturing US Patents Applications covering 14803:
Isis-2710 09/032,972 2/26/98 Pending
Isis-2585 08/950,779 10/15/97 Notice of allowance
Isis-3294 09167,165 10/06/98 Pending
Isis-3380 09/288,679 4/09/99 Pending
Isis-3349 09/271,220 3/17/99 Pending
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SCHEDULE 2
TECHNOLOGICAL COMPETITORS OF ISIS(1)
[ * ]
1. Including any and all divisions or subsidiaries
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* CONFIDENTIAL TREATMENT REQUESTED
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[ISIS PHARMACEUTICALS, INC. LOGO]
Patent Group Use Only
Record of Invention
Docket No. __________
[Illegible}__________
1. ROI TITLE: Folate Conjuated Novel Oligonucleotide Carriers
2. POTENTIAL INVENTORS: Mano Manoharan
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Signature Date
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Signature Date
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Signature Date
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Signature Date
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Signature Date
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Signature Date
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Signature Date
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Signature Date
3. COLLABORATION, SUPPORT: 4. DISCLOSURE:
Is there any corporate collaboration? [ ] Due Date (if applicable): 01/26/2001
If so, who? Reason for Due Date:
5. DATES OF INVENTION:
Conception, on or about (Date): 01/01/1999 By: X. Xxxxxxxxx & B. Bh
First Written Record (Date): By:
Disclosure to Others (Date): 10/04/1999 By: W/X. Xxxx, X. Xxxxxx
First Preparation Work begun (Date): By:
Indicate relevant Lab/Conception Notebook No. and Page No.
5. REVIEWED, READ, UNDERSTOOD, DISCUSSED WITH AND APPROVED BY:
Department Head:
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Print Name Signature Date
Vice President of Research (appropriate department only): [ ] approved [ ] prior invention/filing [ ] trade secret
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Print Name Signature Date
Member of Patent Group:
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Print Name Signature Date
Printed on: 01/26/2000
