EXHIBIT 8
CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO REGULATION
240.25B-2B OF THE SECURITIES EXCHANGE ACT OF 1934. [*] INDICATES OMITTED
MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST AND IS FILED
SEPARATELY WITH THE COMMISSION.
Execution Copy 2A
LICENSE AGREEMENT
BETWEEN
RIBOZYME PHARMACEUTICALS, INC.
AND
MEDIZYME PHARMACEUTICALS LTD.
TABLE OF CONTENTS
1. DEFINITIONS......................................................... 1
2. RPI LICENSE TO NEWCO................................................ 6
3. INTELLECTUAL PROPERTY............................................... 8
4. NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY........................... 8
5. FINANCIAL PROVISIONS................................................ 9
6. RIGHT OF INSPECTION AND AUDIT....................................... 10
7. REPRESENTATIONS AND WARRANTIES...................................... 11
8. TERM AND TERMINATION................................................ 13
9. CONFIDENTIAL INFORMATION............................................ 16
10. GOVERNING LAW AND JURISDICTION; ARBITRATION......................... 17
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE........................ 19
12. ASSIGNMENT.......................................................... 19
13. NOTICES............................................................. 19
14. MISCELLANEOUS....................................................... 21
THIS AGREEMENT made this ___ day of January 2000
between:
(1) Ribozyme Pharmaceuticals, Inc., a Delaware corporation having its principal
place of business at 2950 Wilderness Place, Boulder, Colorado 80301.
(2) Medizyme Pharmaceuticals Ltd., a Bermuda exempted limited liability company
incorporated under the laws of Bermuda and having its registered office at
Clarendon House, Church St., Hamilton, Bermuda.
RECITALS:
---------
A. Simultaneously herewith, RPI, Elan, EIS, and Newco (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 Newco.
B. Newco desires to enter into this Agreement with RPI so as to permit Newco
to utilize the RPI Intellectual Property in making, having made, importing,
using, offering for sale and selling the Products in the Field in the
Territory.
C. Simultaneously herewith Newco and Elan are entering into the Elan License
Agreement relating to Newco's use of the Elan Intellectual Property.
Now, Therefore, the Parties agree as follows:
1. DEFINITIONS
1.1. In this Agreement unless the context otherwise requires:
"Affiliate" shall mean any corporation or entity controlling, controlled or
under the common control of Elan or RPI, 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. For purposes of this Agreement, Newco
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).
[ ]shall mean a Ribozyme targeted against [ * ]
"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
transactions including finance, stock purchase, research and license
agreements.
"EIS" shall mean Elan International Services, Limited, a Bermuda exempted
limited liability company incorporated under the laws of Bermuda and having
its registered office at St James Court, Flatts, Smiths, FL04 Bermuda.
"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.
"Effective Date" shall mean the date of this Agreement.
"Elan Improvements" shall have the meaning as such term is defined in the
Elan License Agreement.
"Elan Intellectual Property" shall have the meaning as such term is defined
in the Elan License Agreement.
"Elan Know-How" shall have the meaning as such term is defined in the Elan
License Agreement.
"Elan License" shall have the meaning set forth in Clause 2.1 of the Elan
License Agreement.
"Elan Patents" shall have the meaning as such term is defined in the Elan
License Agreement.
"Elan Research License" 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.
"Existing RPI License Agreements" shall mean the following agreements: (a)
License Agreement, dated September 1993, between RPI and Competitive
Technologies Inc., as amended; (b) License Agreement, dated January 15,
1993, between RPI and Massachusetts Institute of Technology; (c) License
Agreement, dated February 7, 1992, between RPI and Garching Instruments
GmbH, as amended;
and (d) License Agreement, dated November 11, 1994, between Ribonetics GmbH
and European Molecular Biological Laboratory, as assigned to RPI.
"Field" shall mean the [ * ] of the Target Ribozyme using the System
for the down regulation of HER-2.
"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.
"HER-2" shall mean Human Epidermal Growth Factor Receptor Type 2.
"In Market" shall mean the sale of the Product in the Territory by Newco 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
Newco to an Affiliate or a sub-licensee.
"JDOA" shall mean that certain Joint Development and Operating Agreement,
of even date herewith, by and between Elan, RPI, EIS and Newco.
"Licensed Technologies" shall mean the Elan Intellectual Property and the
RPI Intellectual Property.
"Licenses" shall mean the Elan License, the Elan Research License and the
RPI License.
"Management Committee" shall have the meaning, as such term is defined in
the JDOA.
"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 Newco 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; and
(iv) any tax, excise or governmental charge upon or measured by the sale,
transportation, delivery or use of the Products.
"Newco" shall mean Medizyme Pharmaceuticals Ltd., Bermuda exempted limited
liability company incorporated under the laws of Bermuda.
"Newco Intellectual Property" shall mean the Newco Patents and the Newco
Know- How.
"Newco Know-How" shall mean any and all rights owned, licensed or
controlled by Newco 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 RPI Improvements.
"Newco 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 RPI 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 Newco.
"Oligonucleotide" shall mean a [ * ] non-protein, non-peptide encoding
nucleic acid molecule including those with [ * ] used as a human
therapeutic and/or prophylactic compound comprising between [ * ] including
oligonucleotide analogs which may include natural or non-natural
heterocycles, sugars and/or backbone linkage modifications, capable of
specifically inhibiting the function, activity or expression of a gene. For
the purposes hereof Oligonucleotide (a) shall include [ * ], and (b) shall
exclude polymers in which the linkages are [ ]
"Party" shall mean RPI or Newco, as the case may be, and "Parties" shall
mean RPI and Newco.
"Product(s)" shall mean the pharmaceutical formulation incorporating the
Target Ribozyme and incorporated within or packaged with the System.
"Project" shall mean all activities as undertaken by Elan, RPI and Newco in
order to develop the Products.
"R&D Committee" shall have the meaning, as such term is defined in the
JDOA.
"R&D Plan" shall have the meaning, as such term is defined in the JDOA.
"R&D Program" shall mean any research and development program commenced by
Newco pursuant to the Project.
"Ribozyme" shall mean an [ * ] which is directed to inhibit, by catalytic
cleavage, the translation of mRNA coding for a gene. For the avoidance of
doubt, Ribozyme does not include [ * ]
"RPI" shall mean Ribozyme Pharmaceuticals, Inc., a Delaware corporation and
its Affiliates, excluding Newco.
"RPI Improvements" shall mean improvements to the RPI Patents and/or the
RPI Know-How developed (i) by RPI whether or not pursuant to the Project,
(ii) by Newco or Elan or by a third party (under contract with Newco)
pursuant to the Project, and/or (iii) jointly by any combination of RPI,
Elan or Newco pursuant to the Project, except as limited by agreements with
third parties.
Subject to third party agreements, RPI Improvements shall constitute part
of RPI Intellectual Property and be included in the license of the RPI
Intellectual Property pursuant to Clause 2.1 solely for the purposes set
forth therein. If the inclusion of a RPI Improvement in the license of RPI
Intellectual Property is restricted or limited by a third party agreement,
RPI shall use reasonable commercial efforts to minimize any such
restriction or limitation.
"RPI Intellectual Property" shall mean the RPI Know-How, the RPI Patents
and the RPI Improvements.
"RPI Know-How" shall mean any and all rights owned, licensed or controlled
by RPI to any scientific, pharmaceutical or technical information, data,
discovery, invention (whether patentable or not), technique, process,
procedure, system, formulation or design relating to the Ribozyme that is
not generally known to the public.
"RPI License" shall have the meaning set forth in Clause 2.1.
"RPI 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 RPI containing claims
relating to the Ribozyme.
"RPI Third Party Agreements" shall mean all agreements existing as of the
date hereof between RPI and third parties, including Affiliates, that
relate to or affect the Licenses, the Product, the Ribozyme for use in the
Field, and/or the transactions contemplated hereunder, including, without
limitation, the Existing RPI License Agreements.
"Strategic Investor" shall mean a company, corporation or person investing
in RPI
or Newco for strategic purposes as evidenced by, inter alia, and shall
exclude financial institutions but not any of their direct or indirect
assignees or transferees that are not financial institutions.
"Substitute Ribozyme" shall have the meaning set forth in Clause 2.2 of the
JDOA.
"Substitute Target" shall have the meaning set forth in Clause 2.2 of the
JDOA.
"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 of the Elan License Agreement.
"Target Ribozyme" shall mean a Ribozyme directed to HER-2 unless and until
a [ * ] directed to a [ * ] is designated to be the subject of the Project
pursuant to the designation of a [ * ] and [ * ] under the provisions of
Clause 2.2 of the JDOA, in which case the term [ * ] shall mean such
designated [ * ] directed to [ * ]
"Technological Competitor of Elan" shall mean a company, corporation or
person listed in Schedule 2 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. RPI LICENSE TO NEWCO
2.1. RPI hereby grants to Newco for the Term an exclusive license (including the
limited right to grant sublicenses under Clause 2.6 below) (the "RPI
License") to the RPI Intellectual Property to make, have made, import, use,
offer for sale and sell the Products in the Field in the Territory, subject
to any contractual obligations that RPI has as of the Effective Date.
2.2 RPI hereby confirms that no obligations are in effect on the date hereof
between RPI and an unaffiliated third party relating to the Ribozyme for
use in the Field, other than the Existing RPI License Agreements.
RPI shall be responsible for payments related to the financial provisions
and obligations under the RPI Third Party Agreements (including amendments
thereto), including, without limitation, any royalty or other compensation
obligations. RPI shall satisfy its responsibility to make such payments by
offsetting against such payments the royalties that are otherwise due to
RPI by Newco pursuant to Clause 5 below.
For the avoidance of doubt, royalties, milestones or other payments which
arise from the process of the commercialization or exploitation of products
under the RPI Third Party Agreements (for example, a milestone payment
payable upon successful completion of Phase II clinical trials, the filing
of an NDA application, obtaining NDA approval, or first commercial sale)
shall be payments for which RPI will be responsible under this Clause 2.2.
2.3 To the extent royalty or other compensation obligations that are payable to
third parties with respect to the RPI Intellectual Property would be
triggered after the Effective Date, under any third party agreement entered
into by RPI after the Effective Date (the "RPI Post-Effective Date
Agreements"), by a proposed use of such RPI Intellectual Property in
connection with the Project, RPI will inform Newco of such royalty or
compensation obligations. If Newco agrees to utilize such RPI Intellectual
Property in connection with the Project, Newco will be responsible for the
payment of such royalty or other compensation obligations relating thereto.
For the avoidance of doubt, royalties, milestones or other payments which
arise from the process of the commercialization or exploitation of products
under the RPI Post-Effective Date Agreements (for example, a milestone
payment payable upon successful completion of Phase II clinical trials, the
filing of an NDA application, obtaining NDA approval, or first commercial
sale) shall be payments for which Newco will be responsible under this
Clause 2.3.
2.4 Elan shall be a third party beneficiary under this Agreement and shall have
the right to cause Newco to enforce Newco's rights under this Agreement
against RPI.
2.5 Notwithstanding anything contained in this Agreement to the contrary, RPI
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 RPI Intellectual
Property.
For the avoidance of doubt, Newco shall have no right to use the RPI
Intellectual Property outside the Field.
2.6 Newco shall not assign any of its rights under the RPI License relating to
the RPI Intellectual Property without the prior written consent of Elan and
RPI.
Newco shall not sublicense any of its rights under the RPI License relating
to the RPI Intellectual Property without the prior written consent of Elan
and RPI, which consent shall not be unreasonably withheld or delayed;
provided, however, that the consent of Elan may be withheld in Elan's sole
discretion in the case of a proposed sublicense of such rights to a
Technological Competitor of Elan.
2.7 Any agreement between Newco and any permitted third party for the
development or exploitation of the RPI Intellectual Property shall require
such third party to maintain the confidentiality of all information
concerning the RPI Intellectual Property.
Insofar as the obligations owed by Newco to RPI are concerned, Newco shall
remain responsible for all acts and omissions of any permitted sub-
licensee, including Elan, as if they were acts and omissions by Newco.
3. INTELLECTUAL PROPERTY
3.1 Ownership of Intellectual Property:
-----------------------------------
3.1.1 Newco shall own the Newco Intellectual Property.
3.1.2 RPI shall own the RPI Intellectual Property.
4. NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
4.1 Subject to Clause 4.3, during the Term, RPI, alone or in conjunction with a
third party, shall not develop or commercialize [ * ] to inhibit the
translation of [ * ]
4.2 If after the Effective Date RPI acquires know-how or patent rights from a
third party relating to the System, or if RPI acquires or merges with a
third party entity that owns or has license rights to know-how or patent
rights relating to the System, then RPI shall offer to license such know-
how and patent rights to Newco (subject to existing contractual
obligations) solely for Newco 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.
4.3 If Newco determines that Newco should not acquire such license as is
referred to in Clause 4.2, then RPI shall be free to fully exploit such
know-how and patent rights, with the Elan Intellectual Property licensed to
Newco, whether inside or outside the Field and to grant to third parties
licenses and sublicenses with respect thereto.
5. FINANCIAL PROVISIONS
5.1 Royalties:
----------
The intent of the Parties is to provide for equivalent economic benefit to
each of RPI and Elan, except in respect of the License Fee (as defined in
the Elan License Agreement). Accordingly, the Management Committee shall
decide by unanimous consent on the royalties which shall be payable by
Newco to RPI and Elan on Net Sales. When determining such royalties, the
Management Committee shall consider the royalty obligations of RPI under
the Existing RPI License Agreements, provided that any royalties payable by
Newco to RPI and Elan hereunder shall be distributed in equal amount to
each of RPI and Elan. RPI represents and warrants to Newco and Elan that
RPI's royalty obligations under the Existing RPI License Agreements do not
exceed an aggregate of [ * ]
5.2 Payment of royalties pursuant to Clause 5.1 shall be made quarterly in
arrears during each Financial Year within 30 days after the expiry of the
calendar quarter. The method of payment shall be by wire transfer to an
account specified by RPI. Each payment made to RPI shall be accompanied by
a true accounting of all Products sold by Newco'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.
5.3 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of 3 years:
5.3.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.3.2 to enable any deductions made in the Net Sales calculation to be
determined.
5.4 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.
5.5 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 RPI
the amount of such royalties. In the event that Newco 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 RPI's account in a bank acceptable to RPI in the
country the currency of which is involved or as otherwise agreed by the
Parties.
5.6 RPI and Newco 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.
5.7 Any taxes payable by RPI on any payment made to RPI pursuant to this
Agreement shall be for the account of RPI. If so required by applicable
law, any payment made pursuant to this Agreement shall be made by Newco
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, Newco shall forthwith arrange
payment to RPI 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 RPI, Newco shall permit RPI or its duly authorized
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 Newco and any other book, record, voucher, receipt or invoice
relating to the calculation of the royalty payments on Net Sales submitted
to RPI.
Any such inspection of Newco's records shall be at the expense of RPI,
except that if any such inspection reveals a deficiency in the amount of
the royalty actually paid to RPI hereunder in any Financial Year quarter of
5% or more of the amount of any royalty actually due to RPI hereunder, then
the expense of such inspection shall be borne solely by Newco. Any amount
of deficiency shall be paid promptly to RPI by Newco.
If such inspection reveals a surplus in the amount of royalties actually
paid to RPI by Newco, RPI shall reimburse Newco 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 RPI 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 RPI represents and warrants to Newco and Elan as follows:
7.1.1 RPI has the right to grant the RPI License;
7.1.2 there are no agreements between RPI and any third party that
conflict with the RPI License;
7.1.3 the patents and patent applications included in the RPI Patents are
free and clear of encumbrances and liens;
7.1.4 to the best of RPI's knowledge, there are no proceedings or
threatened proceedings against RPI in connection with the RPI
Intellectual Property in relation to the Field; and
7.1.5 the RPI Intellectual Property constitutes all intellectual property
owned or licensed by RPI that are reasonably applicable to the
Project as it relates to the Ribozyme.
7.2 RPI shall not amend, modify, waive or terminate any of its rights under any
RPI Third Party 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 Newco Intellectual
Property) of Newco.
7.3. RPI agrees and represents and warrants to Newco and Elan as follows: (i)
the RPI Third Party Agreements are valid and in full force and effect, (ii)
there are no existing or claimed defaults by RPI, and to RPI's knowledge by
any other party, under the RPI Third Party 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 RPI Third Party Agreements by RPI, or to RPI's knowledge by any other
party, and (iii) RPI shall during the term of the Licenses, fully comply
with all terms and conditions of the RPI Third Party Agreements; RPI
will enforce its rights under the RPI Third Party Agreements; and RPI will
not assign its rights under the RPI Third Party Agreements. RPI will keep
Newco and Elan fully informed with respect to RPI's arrangements under the
RPI Third Party Agreements that relate to Newco and/or the transactions
contemplated hereunder. RPI shall provide Newco and Elan with any written
notices delivered by any party under the RPI Third Party Agreements, which
written notices relate to or could affect Newco and/or the transactions
contemplated hereunder.
7.4 In addition to any other indemnities provided for herein, RPI shall
indemnify and hold harmless Newco 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 Newco arising out of or in connection
with any:
7.4.1 breach of any representation, covenant, warranty or obligation by
RPI hereunder; or
7.4.2 act or omission on the part of RPI 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, Newco shall
indemnify and hold harmless RPI 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 RPI arising out of or in connection with
any:
7.5.1 breach of any representation, covenant, warranty or obligation by
Newco hereunder; or
7.5.2 act or omission on the part of Newco 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 defense 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, RPI 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, RPI AND NEWCO
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 The term of this Agreement shall commence as of the Effective Date and
shall, subject to the rights of termination outlined in this Clause 8,
expire on a Product-by-Product basis and on a country-by-country basis on
the last to occur of:
8.1.1 [ * ] starting from the date of the first commercial sale of the
Product in the country concerned; or
8.1.2 the date of expiration of the last to expire of the patents included
in the Elan Patents and the Elan Improvements and/or the RPI Patents
and the RPI Improvements
("the Term")
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
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, RPI 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, RPI AND NEWCO
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 The term of this Agreement shall commence as of the Effective Date and
shall, subject to the rights of termination outlined in this Clause 8,
expire on a Product-by-Product basis and on a country-by-country basis on
the last to occur of:
8.1.1 15 years starting from the date of the first commercial sale of the
Product in the country concerned; or
8.1.2 the date of expiration of the last to expire of the patents included
in the Elan Patents and the Elan Improvements and/or the RPI Patents
and the RPI Improvements
("the Term")
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 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, Bermuda or Ireland;
8.3.6 an application or petition for bankruptcy, corporate re-
organization, 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 Upon expiration or termination of the Agreement:
8.4.1. any sums that were due from Newco to RPI 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;
8.4.5 all rights and licenses granted pursuant to this Agreement and to
the RPI Intellectual Property pursuant to the JDOA (including the
rights of Newco pursuant to Clause 11 of the JDOA with respect to
patent prosecution and maintenance; and the rights of Newco to the
RPI Intellectual Property pursuant to Clause 7.2 of the JDOA with
respect to the development and commercialization of [ * ] using the
System) 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 RPI, and Newco 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
Newco to RPI pursuant to the provisions of Clause 12 of the JDOA
(entitled "Cross Licensing/Exploitation of Products Outside the
Field"), all rights to Newco Intellectual Property shall be
transferred to and jointly owned by RPI and Elan and may be
exploited by both Elan and RPI separately, provided that Elan and
RPI will cooperate reasonably in the prosecution and maintenance of
patents claiming such technology and rights and provided further
that nothing hereunder shall grant, or be construed to grant, the
right (a) to Elan to make, have made, import, use, offer for sale or
sell the Target Ribozyme, and (b) to RPI to make, have made, import,
use, offer for sale or sell the System;
In the event of a dispute arising pursuant to this Clause 8.4.6,
Elan and RPI 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; and
8.4.7 the rights of permitted third party sub-licensees in and to the RPI
Intellectual Property shall survive the termination of the license
and sublicense agreements granting said intellectual property rights
to Newco; and Newco, Elan and RPI shall in good faith agree upon the
form most advantageous to Elan and RPI in which the rights of Newco
under any such licenses and sublicenses are to be held (which form
may include continuation of Newco 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 RPI).
Any sublicense agreement between Newco and such permitted
sublicensee shall permit an assignment of rights by Newco 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 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 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 JURISDICTION; ARBITRATION
10.1. This Agreement shall be governed by and construed in accordance with the
laws of the State of New York, without giving effect to the provisions
thereof relating to the conflict 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.
In the event that the Parties fail to agree on a mutually acceptable
dispute resolution mechanism, any such dispute shall be finally settled
by arbitration pursuant to Clause 10.3.
10.3 Any dispute under this Agreement which is not settled by mutual consent
under Clause 10.2 and which relates to (i) the interpretation or
enforcement of any provision of this Agreement, (ii) the interpretation
or application of law, or (iii) the ownership of any intellectual
property shall be finally settled by binding arbitration, conducted in
accordance with the Commercial Arbitration Rules of the American
Arbitration Association ("AAA") by one arbitrator appointed in accordance
with said rules. Such arbitrator shall be an independent expert in
pharmaceutical product development and marketing (including clinical
development and regulatory affairs) and shall be reasonably satisfactory
to each of the Parties; provided, that if the Parties are unable to agree
upon the identity of such arbitrator within 15 days of demand by either
Party, then either Party shall have the right to petition the AAA to
appoint an arbitrator.
The arbitration shall be held in New York, New York.
The arbitrator shall determine what discovery will be permitted,
consistent with the goal of limiting the cost and time which the Parties
must expend for discovery; provided the arbitrator shall permit such
discovery as they deem necessary to permit an equitable resolution of the
dispute.
Any written evidence originally in a language other than English shall be
submitted in English translation accompanied by the original or a true
copy thereof.
The costs of the arbitration, including administrative and arbitrators'
fees, shall be shared equally by the Parties and each Party shall bear
its own costs and attorneys' and witness' fees incurred in connection
with the arbitration.
In rendering judgment, the arbitrators may not provide for punitive or
similar exemplary damages.
A disputed performance or suspended performances pending the resolution
of the arbitration must be completed within 30 days following the final
decision of the arbitrators or such other reasonable period as the
arbitrators determine in a written opinion.
Any arbitration under this Agreement shall be completed within one year
from the filing of notice of a request for such arbitration.
The arbitration proceedings and the decision shall not be made public
without the joint consent of the Parties and each Party shall maintain
the confidentiality of such proceedings and decision unless otherwise
permitted by the other Party.
The Parties agree that the decision shall be the sole, exclusive and
binding remedy between them regarding any and all disputes, controversies,
claims and counterclaims presented to the arbitrators. Application may be
made to any court having jurisdiction over the Party (or its assets)
against whom the decision is rendered for a judicial recognition of the
decision and an order of enforcement.
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither RPI nor Newco 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 Newco at:
Medizyme Pharmaceuticals Ltd.
102 St. James Court
Clarendon House
Church St.
Hamilton, Bermuda
Attention: Secretary
Telephone: 441-295-1422
Fax: 441-292-4720
with a copy to Elan, plc and EPIL at:
Elan Corporation, plc
Elan Pharma International Limited
C/o Elan International Services, Ltd.
102 St. James Court
Flatts,
Smiths FL04
Bermuda
Attention: Secretary
Telephone: 441 292 9169
Fax: 441 292 2224
If to RPI at:
Ribozyme Pharmaceuticals Incorporated
2950 Wilderness Place
Boulder, Colorado 80301
Attention: Chief Executive Officer
Telephone 303-449-6500
Fax: 303-449-6995
with a copy to:
Rothgerber Johnson & Lyons LLP
One Tabor Center, Suite 3000
1200 Seventeenth Street
Denver, Colorado 80202
Attention: Woody Davis, Esq.
Telephone 303-623-9000
Fax: 303-623-9222
If to Elan, plc and/or EPIL at:
Elan Corporation, plc
Elan Pharma International Limited
C/o Elan International Services, Ltd.
102 St. James Court
Flatts,
Smiths FL04
Bermuda
Attention: Secretary
Telephone: 441 292 9169
Fax: 441 292 2224
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:
-------------------
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 inure 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 authorized
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 Elan and Newco as partners, or Elan as an employee of Newco, or
Newco 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.
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED
BY_______________________
For and on behalf of
Ribozyme Pharmaceuticals, Inc.
SIGNED
BY: _____________________
For and on behalf of
Medizyme Pharmaceuticals Ltd.
CONSENTED AND AGREED TO:
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
SCHEDULE 1
----------
RPI PATENTS
CECH PATENTS - US
Title/Invention Patent No. Assignee
- -----------------------------------------------------------------------------------------------------
1 RNA Ribozyme Polymerases, US 4,987,071 University Patents, Inc.
Dephosphorylases, Restriction
Endoribonucleases and Methods
-----------------------------------------------------------------------------------------------------
2 RNA Ribozyme Polymerases, and Methods US 5,037,746 University Patents, Inc.
- ------------------------------------------------------------------------------------------------------
3 RNA Ribozyme Polymerases, US 5,093,246 University Patents, Inc.
Dephosphorylases, Restriction
Endoribonucleases and Methods
- ------------------------------------------------------------------------------------------------------
4 RNA Ribozyme Restriction US 5,116,742 University Patents, Inc.
Endoribonucleases and Methods
- ------------------------------------------------------------------------------------------------------
5 RNA Ribozyme Which Cleaves Substrate RNA US 5,354,855 University Patents, Inc.
Without Formation of a Covalent Bond
- ------------------------------------------------------------------------------------------------------
6 RNA Ribozyme Polymerases, US 5,591,610 University Patents, Inc.
Dephosphorylases, Restriction
Endoribonucleases and Methods
- ------------------------------------------------------------------------------------------------------
CECH PATENTS - FOREIGN
- ------------------------------------------------------------------------------------------------------
1 RNA Ribozyme Polymerases, European Patent No. University Patents, Inc.
Dephosphorylases, Restriction N0. 291533 B1
Endoribonucleases and Methods
- ------------------------------------------------------------------------------------------------------
2 RNA Ribozyme Polymerases, Japanese Patent No. University Patents, Inc.
Dephosphorylases, Restriction No. 2530906
Endoribonucleases and Methods
- ------------------------------------------------------------------------------------------------------
OTHER PATENTS/1/
- -----------------------------------------------------------------------------------------------------
1 ErbB-2/neu Targeted Ribozymes U.S. 5,599,704 RPI
- -----------------------------------------------------------------------------------------------------
2 Method and Reagent for Inhibiting Australian Pat.
Cancer Development No. 687001 RPI
- -----------------------------------------------------------------------------------------------------
3 [ * ] [ * ] RPI
- -----------------------------------------------------------------------------------------------------
4 [ * ] US Patent Pending RPI
- -----------------------------------------------------------------------------------------------------
5 [ * ] US Patent Pending RPI
- -----------------------------------------------------------------------------------------------------
________________
/1/ In addition to the patents listed in this table, RPI has rights to several
patents covering various aspects of ribozyme technology such as chemical
stabilization of ribozymes, new ribozyme motifs, and manufacture of ribozymes,
all of which provide additional coverage for the HERZYME Ribozyme Product. RPI
has rights to 102 issued/allowed patents and over 100 applications pending
worldwide covering various aspects of Ribozyme Technology
SCHEDULE 2/1/
TECHNOLOGICAL COMPETITORS OF ELAN
[ * ]
1. Including any and all divisions or subsidiaries of such entities and
successor entities.