Exhibit 99.4
CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO REGULATION
240.24B-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 COMMISSSION.
MANUFACTURING AND SUPPLY
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AGREEMENT AND SUBLICENSE
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This Manufacturing and Supply Agreement and Sublicense (the "Agreement") is made
and entered into as of this 23rd day of November, 1998 ("Effective Date"), by
and between Ribozyme Pharmaceuticals Incorporated, a Delaware corporation with
offices located at 2950 Wilderness Place, Boulder, CO 80301 (hereinafter "RPI")
and ATUGEN organized under the laws of Germany, and having its principal office
in Berlin, Germany (hereinafter ATUGEN) (together, the "Parties").
WHEREAS, RPI is engaged in research, development and commercialization of
certain patented and/or proprietary nucleic acid technology for therapeutic,
agricultural, animal health, diagnostic and functional genomics applications
(the " RPI Technology");
WHEREAS, RPI has transferred to ATUGEN by license of technology (the "ATUGEN
LICENSE") and assignment of contracts its current Target Validation and
Discovery ("TVD") business, as further set forth in a certain Participation
Agreement which is incorporated by reference herein;
WHEREAS, ATUGEN has agreed to assume RPI 's current TVD business obligations, to
conduct TVD research and development and to perform TVD services subject to
RPI's rights to develop and commercialize with ATUGEN's customers certain human
therapeutics that may be developed as a result of such TVD services;
WHEREAS, ATUGEN may in the future desire to use ribozymes and other technology
covered by the Cech Patents (as defined herein) the rights to which RPI has
acquired pursuant to an Amended and Restated License Agreement between RPI and
Competitive Technologies, Inc. dated November 20, 1996 (the "CTI License").
WHEREAS, RPI wishes to have the right to manufacture and supply all ribozymes
used by ATUGEN in its research and development activities and in its TVD
business and in consideration of such rights, the right to collaborate, develop
and commercialize human therapeutics arising from ATUGEN's business and
reimbursement by ATUGEN of certain of RPI's costs related to the Cech Patents,
RPI is willing to grant a sublicense to the Licensed Technology (as defined
herein).
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NOW THEREFORE, in consideration of the mutual covenants herein contained and
intending to be legally bound hereby, the Parties hereto agree as follows:
Section 1
DEFINITIONS
1.1. "Affiliate" shall mean any corporation or other business entity
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controlled by, controlling, or under common control with ATUGEN. For purpose of
this Section 1.1, "control" shall mean direct or indirect beneficial ownership
of more than thirty percent (30%) of the voting stock or equity, or more than
thirty percent (30%) interest in the income of such corporation or other
business entity.
1.2. "Acquirer" shall mean an entity that intends to or does gain control of
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RPI operations.
1.3. "ATUGEN Patent Rights" shall mean, collectively, all right, title and
--------------------
interest of ATUGEN in, to and under (i) Patents covering ATUGEN Inventions and
(ii) Patents to which ATUGEN is a licensee with the right to sublicense rights
thereunder to RPI.
1.4. "Cech Patents" shall mean the inventions and discoveries which are the
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subject of, or which are covered in whole or in part by, the claims included in
(i) U.S. Patent Application Serial Number 937,327, filed December 3, 1986
entitled RNA RIBOZYME POLYMERASES, DEPHOSPHORYLASES, RESTRICTION
ENDORIBONUCLEASES AND METHODS (the "'327 Patent Application"), (ii) the United
States Patents listed in Appendix A, and any patents issuing thereon as well as
any corresponding patent applications or any patents that may issue thereon
throughout the world, including any extensions, renewals, divisions,
continuations, continuations-in-part, patents of addition, and/or reissues
thereof, including any patent application and any patents issuing thereon
throughout the world including any extensions, renewals, continuations,
continuations-in-part, divisions, patents of additions and/or reissues thereof,
filed upon any invention the practice of which would infringe the claims covered
by the foregoing patents, which invention was made by Thomas R. Cech, Arthur J.
Zaug and Michael D. Been, and/or persons acting under their direction and
control at the University of Colorado, which is the work product of the Research
Support Funding Agreement between USB and the University of Colorado Foundation
entered into on May 20, 1987 (the "RSFA") and which was conceived or reduced to
practice during the term of the RSFA.
1.5. "Change of Control of RPI " shall mean a merger or acquisition by, with
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or of RPI in which the equity holders of RPI immediately prior to such event do
not hold at least 51% of the equity of the resulting entity, and a single new
Acquirer controls
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at least 51% of the equity of the resulting entity or the sale of all or
substantially all the assets of RPI to a third party.
1.6. "COGS" means RIBOZYME's fully-burdened cost of supplying Ribozymes to
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ATUGEN (including raw materials, direct labor, quality control testing,
labeling, packaging and shipping costs). calculated in accordance with RPI's
accounting methods consistently applied and in compliance with U.S. generally
accepted accounting principles (GAAP)
1.7. "Collaborator" shall mean any entity or person engaged in an active
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research and development collaboration with ATUGEN in its Target Validation and
Discovery program.
1.8. "Confidential Information" shall mean confidential and proprietary
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information of ATUGEN or RPI, including without limitation scientific data,
technical reports and business information, disclosed to the other Party,
provided that such information is in writing and marked "CONFIDENTIAL" or with a
similar legend, or is disclosed orally and is reduced to writing and marked
"CONFIDENTIAL" or with a similar legend within 30 days after such disclosure.
1.9. "Delivery Reagents" shall mean all RPI's reagents useful for the delivery
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of Ribozymes to cells that are covered under the Cech Patents, RPI Patent Rights
or RPI Technology.
1.10. "Escrow Technology" shall have the meaning provided under Section 8.7.
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1.11. "Existing Licensee" shall mean third parties to whom RPI has already
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granted certain licenses under RPI Patent Rights in the Field each of which is
listed in the enclosed Appendix B.
1.12. "Field" shall mean any and all applications of Ribozymes in the field of
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human therapeutic Target Validation and Discovery. Such Field will include
functional genomics or gene function identification in human systems, in which
the function of a gene is determined by using the Ribozyme. The Field shall
also include use of the Ribozymes to validate a human therapeutic target.
1.13. "Invention" shall mean any possibly patentable discovery or invention
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that is conceived and reduced to practice that if used, practiced, performed or
sold would infringe on the Cech Patents.
1.14. "Investor" shall mean BB Bio Ventures L.P., and its affliates, all of
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whom are managed by MPM Asset Management, LLC., an affiliate of MPM Capital LP.
1.15. "Licensed Technology" shall mean any technology that is either: (i)
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covered by any Cech Patent; or (ii) constitutes Non-Patented Technology owned
and/or controlled by RPI which is necessary or useful in the Field and which
could not
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be used, practiced, performed, made or sold without infringing on the Cech
Patents but for this Sublicense Agreement.
1.16. "New Invention" shall mean any possibly patentable discovery or
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invention conceived and/or reduced to practice by RPI and/or ATUGEN in the
Field, or by ATUGEN in the RPI Field..
1.17. "Non-Patented Technology" means know-how, trade secrets or other
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information or materials that are not patentable or, for a possibly patentable
discovery or invention, on which the parties choose not to file a patent, which
relate to the Cech Patents and which are either (i) made under this Agreement;
or (ii) are owned or controlled by RPI on the date of this Agreement and are
useful or necessary to the ATUGEN in the Field.
1.18. "Oligonucleotide Market Price" shall mean the price determined by mutual
----------------------------
agreement of the parties as the fair market value for oligonuclotides by
reference to oligonucleotide pricing schedules available from third parties for
the synthesis of an oligonucleotide with chemistry and length equivalent to the
Ribozyme to be supplied under this Agreement.
1.19. "Participation Agreement" shall mean the participation agreement of
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August 24, 1998, and all amendments thereof, executed by ATUGEN and founders of
ATUGEN, including RPI.
1.20. "Patents" shall mean (i) patents (including inventor's certificates)
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that include one or more Valid Claims, including without limitation any
substitution, extension (including supplemental protection certificate),
registration, confirmation, reissue, reexamination or renewal thereof, (ii)
pending applications, including provisional applications, continuations,
divisionals, and continuations-in-part of any of the foregoing. Patent right
"shall" mean RPI and/or ATUGEN patent rights.
1.21. "Patent Right" shall mean RPI Patent Rights and/or ATUGEN Patent Rights.
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1.22. "Ribozyme" shall mean a nucleic acid molecule covered by the claims of
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the Cech Patents.
1.23. "RPI Patent Rights" shall mean collectively, RPI's right, title and
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interest in, to and under the Cech Patents.
1.24. "Ribozyme Product" means any substance that (i) is or is intended to be
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developed and sold commercially for administration to humans or animals or
plants or for therapeutic or diagnostic use and (ii) contains a Ribozyme.
1.25. "RPI Field" shall mean any and all applications of Ribozymes as a human
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or animal therapeutic or diagnostic products or an agricultural product but
excluding any application in the field of Target Validation and Discovery (TVD).
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1.26. "RPI's Supply Profit" shall mean RPI's Profit from the supply of
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Ribozymes, and other reagents covered under the Escrow Technology to ATUGEN
prior to the Change of Control of RPI. Profit as used in this section 1.26
shall mean the price of Ribozymes charged ATUGEN by RPI minus RPI's fully-
burdened COGS.
1.27. "Service Agreement" shall mean the Service Agreement between ATUGEN and
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RPI dated November 23, 1998, and any amendment(s) thereto.
1.28 "Target" means a gene or partial sequence thereof, and those elements
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necessary for its expression or regulation, or its transcription,
translation, or replication product or intermediates or portions
thereof.
1.29. "Target Discovery Technology" means the use of RPI's combinatorial
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ribozyme libraries to identify a Target(s) which, when combined with a target
specific enzymatic nucleic acid molecule, inhibits such Target's expression.
The Target can then be assessed in in vitro and in vivo models for its efficacy
in affecting the phenotype of cells or organism.
1.30. "Target Validation and Discovery (TVD)" means a research program in
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which a nucleic acid molecule, including Ribozymes, is used to determine the
utility of a gene product, for the validation of a therapeutic target, and/or
for the discovery of new genes. Such a program is usually performed on behalf
of a third party Collaborator, but may be performed solely for ATUGEN's benefit
or may consist of technology rights which are licensed or sold to third parties
for use in their own non-nucleic acid-based product development programs outside
the RPI Field.
1.31. "Validated Target" shall mean a Target that has been validated in vitro
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or in vivo as part of a TVD program by ATUGEN or its Collaborator.
1.32. "Valid Claim" shall mean either (i) a claim of an issued and unexpired
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patent included within the Patent Rights, provided that such claim has not been
held permanently revoked, unenforceable or invalid by a decision of a court or
other governmental agency of competent jurisdiction, unappealable or unappealed
within the time allowed for appeal, and has not been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise, or (ii) a claim of a
patent application within the Patent Rights actively being prosecuted.
Section 2
MANUFACTURE AND SUPPLY OF RIBOZYMES AND DELIVERY REAGENTS
2.1 Manufacture of Ribozymes. RPI will manufacture or have manufactured by
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a party acceptable to ATUGEN, provided such acceptance will not be
unreasonably withheld, the Ribozymes required by ATUGEN under this
Agreement. RPI shall provide such material to ATUGEN [ * ] per Ribozyme
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or at [ * ] of the Oligonucleotide Market Price per Ribozyme, which ever is
greater. The price per Ribozyme, however, shall not exceed [ * ] of the
Oligonucleotide Market Price. If the price per Ribozyme exceeds [ * ] of
the Oligonucleotide Market Price, ATUGEN shall have the option to purchase
such Ribozymes from a third party. If the dollar amount of Ribozymes
purchased by ATUGEN from RPI exceeds the dollar amount provided for in
Appendix C attached hereto, then RPI shall provide such material to ATUGEN
at COGS plus [ * ] per Ribozyme or at [ * ] of the Oligonucleotide Market
Price per Ribozyme, which ever is greater. The price per Ribozyme, in such
instance, shall not however exceed [ * ] of the Oligonucleotide Market
Price.
2.2 Exclusivity. During the first five (5) years from the Effective Date of
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this Agreement, ATUGEN shall purchase all its requirement of Ribozymes from
RPI (except as provided in section 2.1 above), which may be extended based
on mutual agreement of the Parties. Other than as provided in sections 2.1,
2.4 and 2.5 herein, nothing in this Agreement is deemed to grant ATUGEN any
right to manufacture or have manufactured the Ribozymes.
2.3 Escrow Technology. RPI shall from time to time place into escrow written
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descriptions of its manufacturing and quality control procedures as may be
necessary for ATUGEN to fully manufacture Ribozymes. ("Escrow Technology")
To facilitate the provisions of this section 2.5, RPI shall promptly
establish such escrow account and provide ATUGEN periodic reports of its
transfer of information to such account. In the event that RPI cannot
adequately supply ATUGEN with its requirements of the Ribozymes within 45
days of written request therefore, as to amounts or in accordance with
ATUGEN's specifications, ATUGEN shall have the right to access the Escrow
technology to manufacture or have manufactured the Ribozymes. RPI's
intellectual property trade secrets related to such technology transfer
shall be treated as Confidential Information of RPI under Section 4.
Specifically, manufacture by third parties will require the same degree of
protection that ATUGEN uses for its most important confidential
information. In the event of a Change in Control of RPI, ATUGEN shall be
entitled to continued access to the Escrow Technology necessary for ATUGEN
to manufacture the Ribozymes for use in the Field.
2.4 Change of Control. In the event of a Change of Control of RPI, unless
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provisions have been made, to the Investor's sole satisfaction, to protect
ATUGEN's and the Investor's interest in the Escrow Technology, then ATUGEN
shall receive and shall have access to the Escrowed Technology and
shallhave a co-exclusive license in the Field to all Patents incorporated
therein, if any one of the following criteria are met:
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2.4.1 More than [ * ] of the Acquirer's annual revenues (according to the
latest reported figures) are from its TVD activities; or
2.4.2 The Acquirer's actions, following the Change of Control of RPI, have
caused RPI activities under this Section 2 to be significantly
reduced, as determined by one or more of the following parameters:
(a) [ * ]
(b) [ * ]
2.4.3 The Acquirer terminates the Service Agreement of November 23, 1998
between RPI and ATUGEN.
2.4.4 ATUGEN unilaterally terminates the Service Agreement of November 23,
1998 between RPI and ATUGEN and/or its obligation to purchase Nucleic
Acid Molecules and Delivery Reagents under this Manufacturing and
Supply Agreement and Sublicense.
2.4.5 If such a transfer of the Escrow Technology to ATUGEN occurs, ATUGEN
agrees to pay to RPI or its successor the following:
(1) ATUGEN shall pay to RPI a one-time fee equal to [ * ] RPI's
Supply Profit during the prior twelve months, if the Service
Agreement was terminated by ATUGEN pursuant to section 2.4.1
above or the Acquirer's actions described in section 2.4.2.
(2) ATUGEN shall pay to RPI a one-time fee equal to [ * ] RPI's
Supply Profit on an annual basis if the Service Agreement was
terminated by ATUGEN under 2.4.4 above.
(3) ATUGEN shall not owe any payment to RPI if the Acquirer
terminates the Service Agreement as described in Section 2.4.3.
2.4.6 All such payments provided in this section 2.4 will be made within
sixty (60) days of the occurance of the indicated event, to RPI or its
successors by ATUGEN, based on revenue and expense records provided by
RPI or its successor to ATUGEN.
2.4.7 In the event the Escrow Technology is accessed by ATUGEN as provided
in this section 2.4, ATUGEN will be responsible for any and all
payments which become due to third parties (including, but not limited
to, the CTI License), as a result of action taken by ATUGEN in the
Field.
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Section 3
SUBLICENSE, GRANT, CONSIDERATIONS,
AND ENFORCEMENT AND DEFENSE
3.1 Grant to ATUGEN.
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3.1.1
RPI hereby grants to ATUGEN an exclusive, with a right to sub-license as
set forth in section 3.1.2 below, worldwide ("Territory") right and
license under the RPI Patent Rights, and Non Patented Technology for the
duration of the Term:
(i) to develop, promote, market, distribute, use, sell, offer to
sell or otherwise dispose of, use and import Licensed
Technology in the Field; and
(ii) to practice and use methods and processes described or claimed
in the RPI Patent Rights within the Field.
Notwithstanding the foregoing, such license shall be co-exclusive with
respect to RPI to the extent that RIBOZYME uses the RPI Patent Rights
and Non-Patented Technology solely for the following purposes:
(a) for RPI's internal research purposes;
(b) to serve the Existing Licensees, if applicable, in the
Field, provided that no rights may be granted to any
Existing Licensee to any New Invention for use in the Field
unless RPI is currently contractually obligated to do so;
(c) for use in collaboration(s) with third parties to conduct
research, develop and commercialize human therapeutic
Ribozyme Products, where such use, with each such third
party collaborator, will involve, within any given six-month
period, examination of no more than five (5) Targets for
each disease indication. RPI, however, will not use the
Target Discovery Technology to identify new Targets in the
Field under a collaboration with a third party nor shall RPI
permit any such third party to conduct any of its own
discovery efforts using the Target Discovery Technology. It
is also understood and agreed by the parties that RPI shall
not develop its own TVD program using any ATUGEN Patent
Rights or any RPI Patent Rights licensed to ATUGEN herein,
subject to the provisions of this Section 3.1.1.
3.1.2 ATUGEN shall have no right to grant sublicenses to any Licensed
Technology, other than Licensed Technology sold or licensed by ATUGEN in
the regular course of its business in the Field or pursuant to a
collaborative drug development or discovery agreement with a third party
in the Field but subject in all cases to the limitations of Section
3.1.5. Such sublicensee shall not have the right to further sublicense
any Licensed Technology under this Agreement without RPI's prior written
consent, which consent shall not be unreasonably withheld, particularly
in the case of territorial sublicenses by a collaborative partner. Any
such sublicenses shall comply with the terms of the CTI License.
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3.1.3 RPI agrees to use reasonable best efforts to prosecute and obtain
issuance of any pending patent applications under the RPI Patent
Rights. Notwithstanding the foregoing, RPI shall not be liable for
failure to obtain issued patents for the pending applications. ATUGEN
shall have the right to prosecute any Patents that RPI decides not to
prosecute and ATUGEN shall bear the cost of prosecuting such Patents.
3.1.4 RPI agrees not to grant licenses under RPI Patent Rights in the Field
to a third party other than pursuant to its existing agreements with
the Existing Licensees.
3.1.5 Notwithstanding the foregoing, RPI shall retain an exclusive right to
develop and commercialize Ribozyme Products in the RPI Field. ATUGEN
agrees, that it will clearly stipulate in its TVD Agreements that RPI
shall retain an exclusive right to develop and commercialize Ribozyme
Products against the Validated Target identified under such TVD
Agreements. ATUGEN shall provide a list of Validated Targets to RPI
once every quarter subject to the confidentiality provisions of
Section 4 herein; provided, however, that in the event of Change of
Control of RPI as set forth in section 2.4, ATUGEN will not be
required to provide such list to RPI.
3.1.6 The parties recognize that the rights granted to RPI by ATUGEN under
this Agreement might be restricted according to the principles,
guidelines, conditions and collateral provisions of public or semi-
public German entities providing or intending to provide grants to
ATUGEN, and the Parties will comply with them.
3.2 Consideration
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3.2.1 In addition to the rights of RPI under sections 2 and 3.1.5, as
further consideration for the rights and license granted to ATUGEN
hereunder, ATUGEN will pay to RPI [ * ] of all future costs and
expenses in connection with prosecution, defense and enforcement of
the Cech Patents, subject to the limitations set forth below.
3.2.2 [ * ]
3.2.3 All payments to be made to RPI by ATUGEN under this Section 3 shall
be paid within thirty (30) days of the receipt of RPI's invoice by
ATUGEN. Checks for all payments to RPI under this Agreement shall be
deposited in the following bank account of RPI:
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Name of the Bank: Norwest Bank of Denver
Address: 1740 Broadway Street, Denver, CO 80204
[ * ]
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For further credit to Norwest Bank of Boulder, Ribozyme
Pharmaceuticals Inc.,
Account No.: [ * ]
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In the event that any payment due to RPI by ATUGEN is delinquent,
interest shall accrue on any overdue amount at the rate of one percent
(1%) per month or the maximum rate permitted by law, whichever is
less.
3.3 Defense. In the event of any claim(s) against ATUGEN, arising within
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[ * ] for infringement of any intellectual property right of any third
party as a direct result of the exercise of the sublicense granted by RPI
to ATUGEN hereunder, RPI shall indemnify and hold harmless ATUGEN, its
officers, directors, licensees and assigns from any and all such claims,
provided, however, that RPI's liability under this Section 3.3 and Section
3.3 of the ATUGEN License shall not exceed [ * ]. RPI shall have sole
control of any such legal action or settlement negotiations and shall have
the right to settle any such litigation by grant of any rights to the
third party provided ATUGEN approves of such grant, which approval shall
not be unreasonably withheld. ATUGEN agrees to assist RPI in defending
such claims.
3.4 Patent Enforcement. RPI and ATUGEN shall each provide immediate written
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notice to the other of any infringement of the Cech Patents in the Field,
which may come to such Party's attention. RPI shall have the exclusive
right to institute and conduct commercially reasonable legal action
against third party infringers of the Cech Patents in the Field, or
negotiate and enter into settlement agreements as deemed appropriate by
RPI after consultation with ATUGEN if necessary. ATUGEN shall provide RPI
with reasonable assistance in any action taken by RPI to enforce the Cech
Patents, but at no point will ATUGEN contribute any amount in excess of
RPI's own contribution to that date in such action. ATUGEN shall have the
option at such time as expenditures pursuant, to this section reach [ * ],
to elect to terminate its license to the Cech Patents and to terminate any
future obligations to participate in the enforcement of the Cech Patents.
Such option shall be renewed upon the expenditure of each [ * ] increment
thereafter. ATUGEN shall not, however be entitled to join RPI as a Party
to any such action. Any award of damages resulting from action taken by
RPI pursuant to this Section 3, after reimbursement of expenses incurred
by RPI and ATUGEN in connection with such action, shall be divided equally
between the parties, provided that such infringement was deemed to have
occurred in the Field and specifically involve the Licensed Technology. If
ATUGEN does not
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participate in such legal action all rights to the Cech Patents granted
ATUGEN hereunder shall revert to RPI and RPI shall then have the right to
use Ribozymes in the Field.
Section 4
CONFIDENTIALITY
4.1 Confidential Information. Any Party receiving any Confidential
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Information from the other Party in connection with the execution, delivery
and performance of this Agreement shall keep, and shall cause its
affiliates, officers, employees, students, technicians, advisors and
consultants to keep, all such Confidential Information in confidence and
shall not disclose such Confidential Information to third parties, except
in connection with a license, sublicense or sale permitted hereunder
requiring such disclosure and containing appropriate confidentiality
provisions.
4.2 Inapplicability. The obligations of confidentiality and nonuse set forth
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in this Agreement shall not apply to any portion of the Confidential
Information which:
(i) is or becomes public or available to the general public otherwise
than through the act or default of the receiving Party or its affiliates or
their employees, advisors or consultants; or
(ii) is obtained by the receiving Party from a third party without a duty
of confidentiality who is lawfully in possession of such Confidential
Information and is not subject to an obligation of confidentiality owed to the
other Party or others; or
(iii) is known, as shown by competent evidence, by the receiving Party or
any of its affiliates prior to disclosure under this Agreement and was not
obtained or derived directly or indirectly from the other Party; or
(iv) is disclosed by the receiving Party or its affiliates pursuant to a
requirement of law, provided that such Party has complied with the provisions
set forth in paragraph 4.3.
4.3 Notice Prior to Disclosure. If the receiving Party, or any of its
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sublicensees or Affiliates becomes legally required to disclose any
Confidential Information, the receiving Party shall give the other Party to
this Agreement prompt notice of such fact so that such Party may obtain a
protective order or other appropriate remedy concerning any such disclosure
and/or waive compliance with the non-disclosure provisions of this
Agreement. The receiving Party and its Affiliates will fully cooperate with
the other Party to this Agreement in connection with such Party's efforts
to obtain any such order or other remedy. If any such order or other remedy
does not fully preclude disclosure
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or the other Party to this Agreement waives such compliance, the receiving
Party and its Affiliates will make such disclosure only to the extent that
such disclosure is legally required and will use its best efforts to have
confidential treatment accorded to the disclosed Confidential Information.
Notwithstanding the foregoing provisions, ATUGEN will be free to disclose
the terms of this Agreement to a third party, including ATUGEN's
Collaborators and potential investors, under confidentiality with such
third parties.
4.4 Term. The obligations of ATUGEN and RPI under this Section 4 shall
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continue for a period of five (5) years after the expiration of this
Agreement.
4.5 Return of Materials. Upon expiration or termination of this Agreement, each
-------------------
Party shall return all copies of Confidential Information disclosed to such
Party, and all other materials provided to such Party under this Agreement;
provided that one copy of such Confidential Information and such materials
may be retained for archival or legal purposes only.
Section 5
LIABILITY AND INDEMNIFICATION
5.1 Indemnification by ATUGEN. ATUGEN agrees to indemnify, hold harmless and
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defend RPI, its officers, employees, and agents, against any and all
claims, suits, losses, damages, costs, fees, and expenses asserted by third
parties, both government and non-government, resulting from or arising out
of any product manufactured or sold by ATUGEN pursuant to the exercise of
this license, other than claims covered by RPI's indemnification in Section
3.3 above. ATUGEN shall not be responsible for the negligence or
intentional wrong doing of RPI.
5.2 Insurance. ATUGEN shall maintain in force at its sole cost and expense,
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with reputable insurance companies, general liability insurance and
products liability insurance coverage in an amount reasonably sufficient to
protect against liability under paragraph 5.1 above. RPI shall have the
right to ascertain from time to time that such coverage exists, such right
to be exercised in a reasonable manner.
5.3 Force Majeure. The Parties will not be liable for any failure to perform
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as required by this Agreement, to the extent such failure to perform is
caused by any reason beyond the control of either Party, or by reason of
any of the following: labor disturbances or disputes of any kind,
accidents, governmental policy, civil disorders, acts of aggression, acts
of God, energy or other conservation measures, failure of utilities,
mechanical breakdowns, material shortages, disease or similar occurrences.
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Section 6
REPRESENTATIONS AND WARRANTIES
6.1 Representations of RPI. RPI represents that RPI has the legal right,
----------------------
authority and power to enter into this Agreement and meet the obligations
set forth herein. RPI further represents that it has not previously
granted other than the rights previously granted to Existing Licensees,
and will not grant to any third party during the term of this Agreement,
any rights under the Cech Patents that are inconsistent with the rights
granted to ATUGEN herein in the Field.
6.2 Representations of ATUGEN. ATUGEN represents and warrants that ATUGEN has
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the legal right, authority and power to enter into this Agreement and meet
the obligations set forth herein.
6.3 Disclaimer. NOTHING IN THIS AGREEMENT SHALL BE DEEMED TO BE A
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REPRESENTATION OR WARRANTY BY RPI OF THE VALIDITY OF ANY OF THE CECH
PATENTS OR THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY PURPOSE,
OF ANY LICENSED TECHNOLOGY, OR RIBOZYME MANUFACTURED BY RPI. RPI SHALL
HAVE NO OBLIGATION, EXPRESS OR IMPLIED, TO SUPERVISE, MONITOR, REVIEW OR
OTHERWISE ASSUME RESPONSIBILITY FOR THE PRODUCTION, MANUFACTURE, TESTING,
MARKETING OR SALE OF ANY LICENSED PRODUCT, AND RPI SHALL HAVE NO LIABILITY
WHATSOEVER TO ATUGEN OR ANY THIRD PARTIES FOR OR ON ACCOUNT OF ANY INJURY,
LOSS, OR DAMAGE, OF ANY KIND OR NATURE, SUSTAINED BY, OR ANY DAMAGE
ASSESSED OR ASSERTED AGAINST, OR ANY OTHER LIABILITY INCURRED BY OR
IMPOSED UPON ATUGEN OR ANY OTHER PERSON OR ENTITY, ARISING OUT OF OR IN
CONNECTION WITH OR RESULTING FROM:
(a) the production, use, or sale of any Licensed Technology or
ribozymes;
(b) the use of any aspect of Inventions; or
(c) any advertising or other promotional activities with respect to any
of the foregoing.
Section 7
TERM AND TERMINATION
7.1 Term. The Term of this Agreement shall commence on the Effective Date and
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shall continue until there are no Valid Claims in existence on the Cech
Patents unless terminated earlier as provided in this Section, and other
than as a result of the Section 2.4.
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7.2 Termination for Cause. Either Party shall have the right to terminate this
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Agreement following any material breach or default in performance under
this Agreement by the other Party upon sixty (60) days prior written notice
by certified mail to the breaching Party specifying the nature of the
breach or default. Unless the breaching Party has either cured or taken
such steps as may be reasonably expected to cure the breach or default
prior to the expiration of such sixty (60) day period, the non-breaching
Party, at its sole option, may terminate this Agreement upon written notice
to the breaching Party. Termination of this Agreement shall become
effective upon receipt of such notice by the breaching Party.
7.3 Effect of Termination. In the event RPI terminates this Manufacturing and
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Supply Agreement and Sub-license Agreement for cause under Section 7.2, RPI
shall retain all the rights granted to RPI by ATUGEN and all the rights
granted to ATUGEN by RPI under this Agreement shall terminate and revert
back to RPI.
7.4 Rights in Law or Equity. Except as otherwise expressly provided herein,
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termination by either Party pursuant to this Section 7 shall not prejudice
any other remedy that a Party might have in law or equity, except that
neither Party may claim compensation for lost opportunity or like
consequential damages arising out of the fact of such termination.
7.5 Termination for Insolvency. To the extent permitted by applicable law,
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either Party may terminate this Agreement immediately upon written notice
without opportunity to cure if the other Party becomes the subject of a
voluntary or involuntary petition in bankruptcy or any proceeding relating
to insolvency, receivership, liquidation, or composition for the benefit of
creditors, if such petition or proceeding is not dismissed with prejudice
within ninety (90) days after filing. In the event of a termination by RPI
for insolvency, the Escrow Technology shall transfer to ATUGEN at no cost.
7.6 Survival. The following Sections of this Agreement shall survive
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expiration or termination of this Agreement: 3.1, 4, 5, 7.6 and 8.
Section 8
GENERAL PROVISIONS
8.1 Dispute Resolution.
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8.1.1 Any disputes arising between the Parties relating to, arising out of
or in any way connected with this Agreement or any term or condition
hereof, or the performance by either Party of its obligations
hereunder, whether before or after termination of this Agreement,
shall be promptly presented to the Chief Executive Officer of RPI
and the Chief
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Executive Officer of ATUGEN (or their designees) for resolution. If
these individuals cannot promptly (within 30 days) resolve such
disputes, then such dispute shall be finally resolved by binding
arbitration. Whenever a Party shall decide to institute arbitration
proceedings, it shall give written notice to that effect to the
other Party. The Party giving such notice shall refrain from
instituting the arbitration proceedings for a period of sixty (60)
days following such notice.
8.1.2 In the event that arbitration is instituted by ATUGEN, such
arbitration shall be held in Berlin, Germany. In the event that
arbitration is instituted by RPI, such arbitration shall be held in
Boulder, Colorado. Judgment on any award rendered by the arbitrator
may be entered in any court having jurisdiction thereof. The Parties
agree that, any provision of applicable law notwithstanding, they
will not request, and the arbitrator shall have no authority to
award, punitive or exemplary damages against any Party.
8.1.3 Notwithstanding the above, in the event of a dispute concerning
inventorship between RPI and ATUGEN, the Parties hereby agree that
each will attempt to resolve such dispute by agreement between two
U.S. patent attorneys (one chosen by each Party) according to U.S.
patent laws. If those two attorneys fail within 30 days to reach a
resolution, then the Parties agree to reach a binding agreement by
negotiation between those two attorneys and a third patent attorney
chosen by those two attorneys. The three attorneys will reach a
binding agreement with regard to the dispute by a majority vote of
the three attorneys. Such dispute will be resolved in this manner
within 60 days from the date of the initial dispute.
8.2 No Use of Name. Neither Party shall use the name of the other in any form
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of advertising publicity or otherwise, any trade-name, personal name,
trademark, trade device, service mark, symbol, or any abbreviation,
contraction or simulation thereof owned by the other party; or public
promotion without the prior written approval of the other, or represent,
either directly or indirectly, that any product or service of the other
party is a product or service of the representing party or that it is made
in accordance with or utilizes the information or documents of the other
party.
8.3 Governing Law. This Agreement shall be governed by, construed, and
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interpreted in accordance with the laws of Germany, including but not
limited to, export control regulations regarding commodities and technical
data/information. Parties specifically agree not to export or re-export any
commodities and/or data/information in violation of any applicable U.S.A.
or German laws and/or regulations.
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8.4 Assignment. This Agreement may not be assigned or transferred by any of
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the Parties hereto without the prior written consent of the other Parties
which will not be unreasonably withheld; provided, however, that ATUGEN may
assign or transfer ATUGEN's rights and obligations under this Agreement to
an affiliate of ATUGEN or a successor to all or substantially all of its
assets or business relating to this Agreement, whether by sale, merger,
operation of law or otherwise upon written notice to RPI.
8.5 Entire Agreement. This Agreement constitutes the entire and only agreement
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between the Parties relating to the subject matter hereof, and all prior
negotiations, representations, agreements and understandings are superseded
hereby.
8.6 Further Assurances. At any time or from time to time on and after the
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Effective Date, RPI and ATUGEN shall at the request of the other (a)
deliver to the other such records, data or other documents consistent with
the provisions of this Agreement, (b) execute, and deliver or cause to be
delivered, all such assignments, consents, documents or further instruments
of transfer or license, and (c) take or cause to be taken all such other
actions, as may reasonably deem necessary or desirable in order to obtain
the full benefits of this Agreement and the transactions contemplated
hereby.
8.7 Notices. Any notice or other communication required or permitted under
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this Agreement shall be in writing and will be deemed given as of the date
such notice is (a) hand delivered, or (b) mailed, postage prepaid, first
class, certified mail, return receipt requested, or (c) sent, shipping
prepaid, receipt requested by national courier service, to the Party at the
address listed below or at such other addresses as may be given from time
to time in accordance with the terms of this notice provision:
If to ATUGEN: ATUGEN Biotechnology GmbH.
Robert-Rossle-Strasse 10
13125 Berlin
Germany
Attention: Managing Director
If to RPI : Ribozyme Pharmaceuticals Inc.
2950 Wilderness Place
Boulder, CO 80301
Attention: President & CEO
8.8 Modification. No modification to this Agreement shall be effective unless
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assented to in writing by the Party to be charged.
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8.9 Waiver. The failure of a party in any instance to insist upon the strict
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performance of the terms of this Agreement will not be construed to be a
waiver or relinquishment of any of the terms of this Agreement, either at
the time of the party's failure to insist upon strict performance or at any
time in the future, and such terms will continue in full force and effect.
8.10 Headings. The headings of the several sections of this Agreement are
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intended for convenience of reference only and are not intended to be a
part of or to affect the meaning or interpretation of this Agreement.
8.11 Severability. In the event that any provision of this Agreement becomes
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or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and
effect without said provision; provided that no such severability shall be
effective if the result of such action materially changes the economic
benefit of this Agreement to ATUGEN, or to RPI.
8.12 Government Clearance. ATUGEN agrees to use commercially reasonable efforts
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to have the Inventions cleared for marketing in those countries in which
ATUGEN intends to sell Licensed Technology by the responsible government
agencies requiring such clearance. To accomplish said clearances at the
earliest possible date, ATUGEN agrees to file, according to the usual
practice of ATUGEN, any necessary data with said government agencies.
8.13 Publication. Each Party shall use its best efforts to provide a copy of
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any publication under this Agreement forty-five (45) days in advance of
such submission for approval by the other party.
8.14 Language. A German and an English version of this Agreement exist. Only
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the English version of this Agreement is binding.
8.15 Counterparts. This Agreement may be executed in counterparts, each of
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which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties hereto, intending to be legally bound hereby,
have caused this Agreement to be executed by their duly authorized
representatives as of the date first written above.
ATUGEN BIOTECHNOLOGY GmbH
By: /s/ Ralph E. Christoffersen
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Name: RALPH E. CHRISTOFFERSEN
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Title: CEO/GESCHAFTSFUHRER
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Date: 11/23/98
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RIBOZYME PHARMACEUTICALS INC.
By: /s/ Larry Bullock
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Name: LARRY BULLOCK
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Title: CFO
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Date: 11/23/98
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APPENDIX A
CECH PATENTS
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- ------------------------------------------------------------------------------------------------
Title/Invention U.S. Patent No. Foreign Patents
- ------------------------------------------------------------------------------------------------
RNA Ribozyme Polymerases, Dephosphorylases,
Restriction Endoribonucleases and Methods 4,987,071 European Patent No.
0291 533
Japanese Patent No.
2530906
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RNA Ribozyme Polymerases, and Methods 5,037,746 N/A
- ------------------------------------------------------------------------------------------------
RNA Ribozyme Polymerases, Dephosphorylases,
Restriction Endoribonucleases and Methods 5,093,246 N/A
- ------------------------------------------------------------------------------------------------
RNA Ribozyme Restriction Endoribonucleases and
Methods 5,116,742 N/A
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RNA Ribozyme Which Cleaves Substrate RNA Without
Formation of a Cavalent Bond 5,354,855 N/A
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RNA Ribozyme Polymerases, Dephosphorylases,
Restriction Endoribonucleases and Methods 5,591,610 N/A
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APPENDIX B
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Listing of Existing Licensees Effective Date
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Schering AG, Germany 4/9/97
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Roche Bioscience 5/19/98
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Chiron 5/13/96
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Glaxo-Wellcome 7/16/98
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Parke-Davis 3/2/98
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