*Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
200.83 and 240b-2
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
ISIS PHARMACEUTICALS, INC.
AND
HYBRIDON, INC.
TABLE OF CONTENTS
PAGE
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ARTICLE I DEFINITIONS.........................................................1
SECTION 1.1 "AFFILIATE"....................................................1
SECTION 1.2 "AMINO PATENT RIGHTS"..........................................2
SECTION 1.3 "ANTISENSE PRODUCTS"...........................................2
SECTION 1.4 "ANTISENSE TECHNOLOGY"........................................2
SECTION 1.5 "CONFIDENTIAL INFORMATION".....................................2
SECTION 1.6 "DOCKET 104"...................................................2
SECTION 1.7 "DOCKET 105"...................................................3
SECTION 1.8 "DRUG POTENTIATION PATENT RIGHTS"..............................3
SECTION 1.9 "EXHIBIT K PATENTS"............................................3
SECTION 1.10 "FACILITATOR PATENT RIGHTS"...................................3
SECTION 1.11 "FINDERON PATENT RIGHTS"......................................3
SECTION 1.12 "HYBRIDON ANTISENSE DRUG".....................................4
SECTION 1.13 "HYBRIDON ANTISENSE PATENT RIGHTS"............................4
SECTION 1.14 "HYBRIDON EXCLUDED PATENT RIGHTS".............................5
SECTION 1.15 "HYBRIDON INTELLECTUAL PROPERTY"..............................5
SECTION 1.16 "IMMUNE STIMULATION PATENT RIGHTS"............................5
SECTION 1.17 "ISIS INTELLECTUAL PROPERTY RIGHTS"...........................5
SECTION 1.18 [*]
SECTION 1.19 "MOTIFS"......................................................6
SECTION 1.20 "NAKED SUBLICENSE"............................................6
SECTION 1.21 "NON-PARENT AFFILIATE"........................................6
SECTION 1.22 "OPTIMIZATION"................................................6
SECTION 1.23 "PARTY".......................................................6
SECTION 1.24 "RIBOZYMES"...................................................6
SECTION 1.25 "RIBOZYME TECHNOLOGY".........................................6
SECTION 1.26 "RNASEH DEPENDENT MECHANISMS OF ACTION".......................7
SECTION 1.27 "SUBLICENSE INCOME"...........................................7
*Confidential Treatment Requested - i -
SECTION 1.28 "SUBLICENSEE".................................................7
SECTION 1.29 "SUBSIDIARY"..................................................7
SECTION 1.30 "THIRD PARTY LICENSE AGREEMENTS"..............................8
SECTION 1.31 "XXXXXX NET SALES"............................................8
SECTION 1.32 "XXXXXX PATENTS"..............................................8
SECTION 1.33 "XXXXXX PRODUCT"..............................................8
SECTION 1.34 "UMASS PATENT RIGHTS".........................................8
SECTION 1.35 "VALID CLAIM".................................................8
ARTICLE II GRANT OF RIGHTS BY HYBRIDON........................................9
SECTION 2.1 LICENSE GRANT..................................................9
SECTION 2.2 SUBLICENSING RIGHT............................................11
SECTION 2.3 NO IMPLIED LICENSES; RETAINED RIGHTS..........................13
SECTION 2.4 COMMERCIALIZATION EFFORTS.....................................13
SECTION 2.5 LICENSE AGREEMENTS TO WHICH HYBRIDON IS A PARTY...............13
SECTION 2.6 METHYLGENE LICENSE AGREEMENT..................................14
SECTION 2.7 ORIGENIX LICENSE AGREEMENT....................................14
SECTION 2.8 AFFILIATES....................................................14
ARTICLE III GRANT OF RIGHTS BY ISIS..........................................14
SECTION 3.1 LICENSE GRANT.................................................14
SECTION 3.2 SUBLICENSING RIGHT............................................14
SECTION 3.3 XXXXXX PATENTS................................................15
SECTION 3.4 SCOPE OF LICENSE..............................................16
SECTION 3.5 NO IMPLIED LICENSES...........................................17
SECTION 3.6 LIMITATION ON LICENSE GRANT WITH RESPECT TO TARGET
VALIDATION AND GENE FUNCTIONALIZATION ACTIVITIES.........17
SECTION 3.7 NOTICE OF HYBRIDON ANTISENSE DRUGS............................17
SECTION 3.8 AFFILIATES....................................................18
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ARTICLE IV PAYMENT OBLIGATIONS................................................18
SECTION 4.1 CONSIDERATION FOR LICENSES OF HYBRIDON INTELLECTUAL
PROPERTY AND ISIS INTELLECTUAL PROPERTY.................18
SECTION 4.2 CONSIDERATION FOR SUBLICENSE OF XXXXXX PATENTS................18
SECTION 4.3 ISIS SUBLICENSE INCOME........................................19
SECTION 4.4 RECORDS; AUDITS...............................................19
SECTION 4.5 PAYMENT CURRENCY..............................................19
SECTION 4.6 LATE PAYMENTS; COLLECTIONS....................................19
ARTICLE V COLLABORATION......................................................20
ARTICLE VI INTELLECTUAL PROPERTY PROTECTION...................................20
SECTION 6.1 PATENT PROSECUTION AND COOPERATION............................20
SECTION 6.2 ENFORCEMENT OF HYBRIDON ANTISENSE PATENT RIGHTS...............24
ARTICLE VII CONFIDENTIALITY..................................................27
SECTION 7.1 CONFIDENTIAL INFORMATION......................................27
ARTICLE VIII DISPUTE RESOLUTION..............................................28
ARTICLE IX TERM AND TERMINATION...............................................29
SECTION 9.1 TERM..........................................................29
SECTION 9.2 TERMINATION OF LICENSES AND SUBLICENSES FOR BREACH............30
SECTION 9.3 TERMINATION OF SUBLICENSE OF XXXXXX PATENTS...................31
SECTION 9.4 SURVIVAL......................................................31
SECTION 9.5 SUBLICENSE SURVIVAL...........................................31
SECTION 9.6 FAILURE TO MAKE MASTER AGREEMENT DELIVERIES...................32
ARTICLE X MISCELLANEOUS PROVISIONS............................................32
SECTION 10.1 INDEMNIFICATION..............................................32
SECTION 10.2 GOVERNING LAW................................................33
SECTION 10.3 ASSIGNMENT...................................................33
SECTION 10.4 ENTIRE AGREEMENT; AMENDMENTS.................................33
SECTION 10.5 NOTICES......................................................33
SECTION 10.6 FORCE MAJEURE................................................35
SECTION 10.7 DISCLOSURE OF PROVISIONS OF AGREEMENT........................35
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SECTION 10.8 INDEPENDENT CONTRACTORS......................................36
SECTION 10.9 NO STRICT CONSTRUCTION.......................................36
SECTION 10.10 HEADINGS....................................................36
SECTION 10.11 NO IMPLIED WAIVERS; RIGHTS CUMULATIVE.......................36
SECTION 10.12 SEVERABILITY................................................37
SECTION 10.13 EXECUTION IN COUNTERPARTS...................................37
SECTION 10.14 NO CONSEQUENTIAL DAMAGES....................................37
SECTION 10.15 PATENT VALIDITY.............................................37
EXHIBITS:
---------
Exhibit A through Exhibit G - Omitted
Exhibit H-1 - Third Party License Agreements
Exhibit H-2 - Other License Agreements
Exhibit I - Xxxxxx Patents
Exhibit J - UMass Agreement
Exhibit K - Excluded Hybridon Intellectual Property
Exhibit L - UMass Patent Rights
Exhibit M - Drug Potentiation Patent Rights
Exhibit N - Xxxxxx Agreement
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COLLABORATION AND LICENSE AGREEMENT
This
Collaboration and License Agreement (the "Agreement") is entered into
as of the 24th day of May, 2001 (the "Effective Date") by and between Isis
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
the State of
Delaware ("Isis"), and Hybridon, Inc., a corporation organized and
existing under the laws of the State of
Delaware ("Hybridon").
INTRODUCTION
1. Hybridon is the owner or has the right to use under license certain
patents and patent applications relating to the practice of Antisense Technology
(as defined below).
2. Isis is the owner or has the right to use under license certain patents
and patent applications relating to the practice of Antisense Technology.
3. Hybridon and Isis are interested in licensing or sublicensing to the
other party these patents and patent applications and in collaborating from time
to time on the further research and development of Antisense Products.
4. Hybridon and Isis have entered into a Master Agreement dated as of the
date hereof (the "Master Agreement").
5. Isis and Hybridon each recognizes that the other Party has expended
significant efforts and resources in the research and development of Antisense
Technology and the payments to be made under the Master Agreement to each Party
for the patent licenses and sublicenses granted hereunder will allow each Party
to recoup such expenditures.
NOW, THEREFORE, Hybridon and Isis agree as follows:
ARTICLE I
DEFINITIONS
When used in this Agreement, each of the following terms shall have the meanings
set forth in this Article I:
Section 1.1 "AFFILIATE". Affiliate shall mean, with respect to a person or
entity, any corporation, company, partnership, joint venture or other entity
which controls, is controlled by, or is under common control with such person or
entity. For purposes of this Section 1.1 and Section 1.21, "control" shall mean
(a) in the case of corporate entities, direct or indirect ownership of fifty
percent (50%) or more of the stock or shares having the right to vote for the
election of directors, and (b) in the case of non-corporate entities, direct or
indirect ownership of fifty percent (50%) or more of the equity interest with
the
power to direct the management and policies of such non-corporate entities,
provided that in either such case such person or entity has the power to direct
the management and policies of such entities, whether by contract or through
representation on the board of directors or other governing body of such
entities.
Section 1.2 "AMINO PATENT RIGHTS". Amino Patent Rights shall mean the
claims of all patents and patent applications set forth on EXHIBIT A hereto and
any continuations or divisions thereof, any patent issued with respect to any
such patent applications, any reissue, reexamination, renewal or extension
(including any supplemental patent certificate) of any such patent, any
confirmation patent or registration patent or patent of addition based on any
such patent, and all foreign counterparts of any of the foregoing.
Section 1.3 "ANTISENSE PRODUCTS". Antisense Products shall mean
oligonucleotides or oligonucleotide analogs or mimics thereof targeted to a
specific sequence of RNA that hybridize to such sequence and through such
hybridization modulate the production of the targeted gene product. The term
Antisense Products shall not include Ribozymes.
Section 1.4 "ANTISENSE TECHNOLOGY". Antisense Technology shall mean the
use of any oligonucleotide or oligonucleotide analog or mimic thereof targeted
to a specific sequence of RNA that hybridizes to such sequence and through such
hybridization modulates the production of the targeted gene product. The term
Antisense Technology shall not include Ribozyme Technology.
Section 1.5 "CONFIDENTIAL INFORMATION". Confidential Information shall
mean all information, including, without limitation, proprietary information and
materials (whether or not patentable) regarding a Party's technology, products,
business information or objectives, which is designated as confidential in
writing by the disclosing Party, whether by letter or by the use of an
appropriate stamp or legend, prior to or at the time any such information is
disclosed by the disclosing Party to the other Party. Notwithstanding the
foregoing, all information which is orally, electronically or visually disclosed
by a Party, or is disclosed in writing without an appropriate letter, stamp or
legend, shall constitute Confidential Information of a Party if the disclosing
Party, within thirty (30) days after such disclosure, delivers to the other
Party a written document or documents describing the information and referencing
the place and date of such oral, visual, electronic or written disclosure and
the names of the persons to whom such disclosure was made.
Section 1.6 "DOCKET 104". Docket 104 shall mean all patents and patent
applications set forth on EXHIBIT B-1 hereto and any continuations or divisions
thereof, any patent issued with respect to any such patent applications, any
reissue, reexamination, renewal or extension (including any
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supplemental patent certificate) of any such patent, any confirmation patent or
registration patent or patent of addition based on any such patent, and all
foreign counterparts of any of the foregoing.
Section 1.7 "DOCKET 105". Docket 105 shall mean all patents and patent
applications set forth on EXHIBIT B-2 hereto and any continuations or divisions
thereof, any patent issued with respect to any such patent applications, any
reissue, reexamination, renewal or extension (including any supplemental patent
certificate) of any such patent, any confirmation patent or registration patent
or patent of addition based on any such patent, and all foreign counterparts of
any of the foregoing.
Section 1.8 "DRUG POTENTIATION PATENT RIGHTS". Drug Potentiation Patent
Rights shall mean the claims of all patents and patent applications set forth on
EXHIBIT M hereto and any continuations or divisions thereof, any patent issued
with respect to any such patent applications, any reissue, reexamination,
renewal or extension (including any supplemental patent certificate) of any such
patent, any confirmation patent or registration patent or patent of addition
based on any such patent, and all foreign counterparts of any of the foregoing.
Section 1.9 "EXHIBIT K PATENTS". Exhibit K Patents shall mean the claims
of all patents and patent applications set forth on EXHIBIT K hereto and any
continuations or divisions thereof, any patent issued with respect to any such
patent applications, any reissue, reexamination, renewal or extension (including
any supplemental patent certificate) of any such patent, any confirmation patent
or registration patent or patent of addition based on any such patent, and all
foreign counterparts of any of the foregoing.
Section 1.10 "FACILITATOR PATENT RIGHTS". Facilitator Patent Rights shall
mean the claims of all patents and patent applications set forth on EXHIBIT C
hereto and any continuations or divisions thereof, any patent issued with
respect to any such patent applications, any reissue, reexamination, renewal or
extension (including any supplemental patent certificate) of any such patent,
any confirmation patent or registration patent or patent of addition based on
any such patent, and all foreign counterparts of any of the foregoing.
Section 1.11 "FINDERON PATENT RIGHTS". Finderon Patent Rights shall mean
the claims of all patents and patent applications set forth on EXHIBIT D hereto
and any continuations or divisions thereof, any patent issued with respect to
any such patent applications, any reissue, reexamination, renewal or extension
(including any supplemental patent certificate) of any such patent, any
confirmation patent or registration patent or patent of addition based on any
such patent, and all foreign counterparts of any of the foregoing.
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Section 1.12 "HYBRIDON ANTISENSE DRUG". Hybridon Antisense Drug shall mean
an Antisense Product which is a therapeutic or prophylactic product for the
treatment or prevention of disease in a human or an animal that is discovered,
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developed and/or Optimized either by Hybridon or a Subsidiary alone or as
part of a "bona fide drug discovery collaboration".
For purposes of this Section 1.12 only, a "bona fide drug discovery
collaboration" is an arrangement between Hybridon or a Subsidiary and a third
party (i) in which the intent of the collaborators in engaging in discovery,
development and/or Optimization activities is to discover, develop, Optimize and
commercialize an Antisense Product. [*] Initiation of IND supporting
toxicology is the initiation of animal toxicity studies in support of the filing
of an Investigational New Drug application with the U.S. Food and Drug
Administration or a similar regulatory filing with a similar regulatory
authority in another jurisdiction. If a contractor (which is not the third party
collaborator) in the business of performing preclinical studies provides such
services through the performance of IN VIVO animal studies under the supervision
of Hybridon or a Subsidiary, the services so provided shall be treated as work
performed directly by Hybridon or a Subsidiary for purposes of this definition.
Work performed by a contractor of, and paid for by, Hybridon or a Subsidiary
under the supervision of Hybridon or a Subsidiary shall be treated as work
performed directly by Hybridon or a Subsidiary for purposes of this definition.
The Parties acknowledge that a part of the discovery, development and
Optimization of an Hybridon Antisense Drug may involve the validation and
prioritization of gene targets to form the basis for antisense drug discovery
activities.
In the event of a sale or other transfer of the assets of Hybridon, no
Antisense Product developed by the acquiring company prior to the acquisition
will be deemed to be a Hybridon Antisense Drug unless (i) such acquiring company
acquires all or substantially all of the assets of the antisense business of
Hybridon, and (ii) such Antisense Product [*]by the acquiring company prior to
the acquisition; provided, however, that an Antisense Product that would qualify
as a Hybridon Antisense Drug irrespective of the acquisition will not lose its
status as such as a result of such acquisition.
Section 1.13 "HYBRIDON ANTISENSE PATENT RIGHTS". Hybridon Antisense Patent
Rights shall mean the claims of all patents and patent applications and any
continuations or divisions thereof, whether now existing, now filed or later
filed on inventions invented, licensed or sublicensed by Hybridon prior to April
26, 2001, any patent issued with respect to any such patent applications, any
reissue, reexamination, renewal or extension (including any supplemental patent
certificate) of any such patent, any confirmation patent or registration patent
or patent of addition based on any such patent, and all foreign counterparts of
any of the foregoing, which Hybridon owned or had the right to sublicense as of
April 26, 2001 and which are necessary or useful to practice Antisense
Technology, including without limitation the patents and patent applications set
forth on EXHIBIT E, but not including the Hybridon Excluded Patent Rights and
the patents and patent
* Confidential Treatment Requested - 4 -
applications licensed to Hybridon (the "Hybridon IDT Patent Rights") pursuant
to the Non-Exclusive License Agreement dated as of March 12, 1999 between
Integrated DNA Technologies, Inc. ("IDT") and Hybridon.
Section 1.14 "HYBRIDON EXCLUDED PATENT RIGHTS". Hybridon Excluded Patent
Rights shall mean the Amino Patent Rights, Docket 104, Docket 105, Facilitator
Patent Rights, Finderon Patent Rights, Immune Stimulation Patent Rights, Drug
Potentiation Patent Rights and the Exhibit K Patents.
Section 1.15 "HYBRIDON INTELLECTUAL PROPERTY". Hybridon Intellectual
Property shall mean collectively the Hybridon Antisense Patent Rights and the
Hybridon Excluded Patent Rights (all solely to the extent licensed to Isis under
Section 2.1), but shall exclude the Hybridon IDT Patent Rights.
Section 1.16 "IMMUNE STIMULATION PATENT RIGHTS". Immune Stimulation Patent
Rights shall mean the claims of all patents and patent applications set forth on
EXHIBIT F hereto and any continuations or divisions thereof, any patent issued
with respect to any such patent applications, any reissue, reexamination,
renewal or extension (including any supplemental patent certificate) of any such
patent, any confirmation patent or registration patent or patent of addition
based on any such patent, and all foreign counterparts of any of the foregoing.
Section 1.17 "ISIS INTELLECTUAL PROPERTY RIGHTS". Isis Intellectual
Property Rights shall mean the claims that cover Motifs or RNaseH Dependent
Mechanisms of Action of all patents and patent applications and any
continuations or divisions thereof, whether now existing, now filed or later
filed on inventions invented, licensed or sublicensed by Isis prior to April 26,
2001, any patent issued with respect to any such patent applications, any
reissue, reexamination, renewal or extension (including any supplemental patent
certificate) of any such patent, any confirmation patent or registration patent
or patent of addition based on any such patent, and all foreign counterparts of
any of the foregoing, which Isis owned or had the right to sublicense as of
April 26, 2001, including without limitation the patents and patent applications
set forth on EXHIBIT G hereto; provided, however, that Isis Intellectual
Property Rights shall not include manufacturing methods, including without
limitation reagents, synthons and processes used in manufacturing and analyzing
oligonucleotides; chemistries, including without limitation modifications made
to the backbone, sugar or base of an oligonucleotide and oligonucleotide
conjugates (including the chemistries of the conjugate and the conjugation
methods); formulations, including without limitation methods and reagents for
delivery and uptake of oligonucleotides; gene-related patents, including without
limitation patents to specific gene structures, gene targets and treatments
based upon a genetic target; and patents and patent applications licensed to
*Confidential Treatment Requested - 5 -
Isis pursuant to the Non-Exclusive License Agreement dated March 19, 1999
between IDT and Isis.
Section 1.18 [*]
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Section 1.19 "MOTIFS". Motifs shall mean hybrid oligonucleotide structures
that have at least two regions within the oligonucleotide that have different
chemistries, one of which will support cleavage via RNaseH Dependent Mechanisms
of Action. Motifs do not include specific chemistries necessary or useful to
create or Optimize such structures, whether or not such chemistries are also
disclosed by or claimed in the same patent or patent application.
Section 1.20 "NAKED SUBLICENSE". Naked Sublicense shall mean any license
or sublicense of intellectual property granted by a Party or a Subsidiary to a
third party other than a license or sublicense which is granted as part of a
bona fide research, development, manufacturing or commercialization
collaboration between the Party or a Subsidiary and the third party (it being
agreed by the Parties that the definition of the term "collaboration" in this
Section 1.20 shall not be interpreted by reference to the definition of
collaboration used in Section 1.12). For purposes of this definition, a bona
fide research, development, manufacturing or commercialization collaboration may
include collaborative research and discovery, including without limitation gene
functionalization and target validation.
Section 1.21 "NON-PARENT AFFILIATE". Non-Parent Affiliate shall mean, with
respect to a person or entity, any Affiliate of such person or entity other than
any corporation, company, partnership, joint venture or other entity which
controls (as defined in Section 1.1) such person or entity.
Section 1.22 "OPTIMIZATION". Optimization shall mean the process by which
the properties of an Antisense Product are improved by making chemical
modifications to such Antisense Product or by selecting a different sequence of
RNA for such Antisense Product.
Section 1.23 "PARTY". Party shall mean Isis or Hybridon; "Parties" shall
mean Isis and Hybridon. As used in this Agreement, references to "third parties"
do not include a Party or its Subsidiaries.
Section 1.24 "RIBOZYMES". Ribozymes shall mean oligonucleotides or
oligonucleotide analogs or mimics containing a catalytic core having a bulge or
stem loop and regions flanking the catalytic core that hybridize to a targeted
RNA and modulate the targeted RNA by cleavage at a site next to a specific
ribonucleotide triplet by an oligonucleotide catalyzed transesterification
reaction.
Section 1.25 "RIBOZYME TECHNOLOGY". Ribozyme Technology shall mean the use
of any oligonucleotides or oligonucleotide analogs or mimics thereof containing
a catalytic core having a bulge or stem loop and regions flanking the catalytic
core that hybridize to a targeted RNA and modulate the
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targeted RNA by cleavage at a site next to a specific ribonucleotide triplet
by an oligonucleotide catalyzed transesterification reaction.
- 7 -
Section 1.26 "RNASEH DEPENDENT MECHANISMS OF ACTION". RNaseH Dependent
Mechanisms of Action shall mean methods of using RNaseH enzymes to cleave a
targeted RNA in vitro or in vivo. RNaseH Dependent Mechanisms of Action do not
include chemistries necessary or useful to facilitate or Optimize such cleavage,
whether or not such chemistries are also disclosed by or claimed in the same
patent or patent application.
Section 1.27 "SUBLICENSE INCOME". Sublicense Income shall mean all
consideration received from Sublicensees by Isis or a Subsidiary pursuant to a
Naked Sublicense by Isis or a Subsidiary which covers, in whole or in part,
Hybridon Intellectual Property and all consideration received from Sublicensees
by Isis or an Affiliate pursuant to a Naked Sublicense not involving Hybridon
Intellectual Property if such Naked Sublicense arose out of the same transaction
as, or was otherwise related to, a Naked Sublicense which covers, in whole or in
part, Hybridon Intellectual Property. Sublicense Income does not include (i)
payments made by a Sublicensee in consideration for the issuance of equity or
debt securities of Isis to the extent such payments do not exceed the fair
market value of the securities being issued. [*] If non-monetary consideration
is received from Sublicensees by Isis or its Subsidiaries, then a commercially
reasonable monetary value will be assigned for purposes of calculating
Sublicense Income.
Section 1.28 "SUBLICENSEE". Sublicensee shall mean any third party granted
the right hereunder by a Party, its Subsidiaries or a Sublicensee having the
right to grant further sublicenses, to discover, develop, make, have made, use,
sell, have sold, offer to sell, import or have imported products covered by the
Hybridon Intellectual Property (in the case of a Sublicensee of Isis, its
Subsidiaries or a Sublicensee having the right to grant further sublicenses) or
Isis Intellectual Property or Xxxxxx Patents (in the case of a Sublicensee of
Hybridon, its Subsidiaries or a Sublicensee having the right to grant further
sublicenses).
Section 1.29 "SUBSIDIARY". Subsidiary shall mean with respect to a Party,
any corporation, company, partnership, joint venture or other entity, 100% of
the equity securities of which are directly or indirectly owned by such Party;
provided, however, that if such Party does not directly or indirectly own 100%
of the equity securities of the entity, such entity shall nevertheless be deemed
a Subsidiary for purposes of this definition if the equity securities not owned
directly or indirectly by such Party consist solely of: (a) director qualifying
shares, (b) equity securities of the entity owned by employees, directors or
officers of the Party or the entity so long as such ownership by employees,
directors and officers does not exceed 10% of the equity securities of the
entity and/or (c) in the case of entities, the operations of which are
substantially conducted outside the United States, equity securities of the
entity owned by financial investors so long as such ownership by financial
investors does not exceed 20% of the equity securities of the entity. For
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purposes of this Section 1.29, indirect ownership shall mean ownership through
an entity or a chain
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Section 1.30 of entities as to each member of which the Party or another
entity in the chain owns 100% of the equity securities (other than director
qualifying shares).
Section 1.31 "THIRD PARTY LICENSE AGREEMENTS". Third Party License
Agreements shall mean those agreements set forth on EXHIBIT H-1 attached hereto
pursuant to which Hybridon has licensed Hybridon Intellectual Property to third
parties.
Section 1.32 "XXXXXX NET SALES". Xxxxxx Net Sales shall mean the gross
sales revenues received by Hybridon, its Subsidiaries or Sublicensees from the
sale of Xxxxxx Products, minus (a) all sales, use, and excise taxes, and customs
duties or other charges; (b) transportation and handling charges (including
transport insurance) actually incurred and paid by the buyer as part of the
purchase price; and (c) amounts repaid or credited by reason of rejections or
returns. Sales of a Xxxxxx Product by Hybridon to a Subsidiary of Hybridon for
sale by the Subsidiary shall not be considered a sale of Xxxxxx Products
hereunder.
Section 1.33 "XXXXXX PATENTS". Xxxxxx Patents shall mean the Technology
Rights (as defined in the Non-Exclusive Patent License Agreement dated September
14, 1992 (the "Xxxxxx Agreement") between Isis and Molecular Biosystems, Inc.
("MBI")) licensed by Isis from MBI under the Xxxxxx Agreement, including without
limitation the patents and patent applications set forth on EXHIBIT I hereto.
Section 1.34 "XXXXXX PRODUCT". Xxxxxx Product shall mean any product whose
use, manufacture or sale by Hybridon, its Subsidiaries or Sublicensees, in any
jurisdiction in which a patent which is a Xxxxxx Patent has been allowed, would
but for the provisions of Section 3.3 constitute an infringement of such patent.
Section 1.35 "UMASS PATENT RIGHTS". UMass Patent Rights shall mean the
Patent Rights (as defined in the UMass Agreement (as defined below)) licensed by
Hybridon from UMass under the UMass Agreement, including without limitation the
patents and patent applications set forth on EXHIBIT L hereto.
Section 1.36 "VALID CLAIM". Valid Claim shall mean a claim which (i) in
the case of any unexpired United States or foreign patent, shall not have been
donated to the public, disclaimed or held invalid or unenforceable by a court of
competent jurisdiction in an unappealed or unappealable decision, or (ii) in the
case of any United States or foreign patent application, shall not have been
permanently cancelled, withdrawn, abandoned or been pending for more than seven
(7) years.
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ARTICLE II
GRANT OF RIGHTS BY HYBRIDON
Section 2.1 LICENSE GRANT.
(a) License Grant to Hybridon Antisense Patent Rights. Subject to
the terms and conditions of this Agreement, including without limitation
Hybridon's retained rights under Section 2.3 and Section 2.5(a) of this
Agreement, Hybridon hereby grants to Isis and its Subsidiaries an exclusive
worldwide license or sublicense, as applicable, under the Hybridon Antisense
Patent Rights, to practice Antisense Technology and to discover, develop, make,
have made, use, sell, have sold, offer to sell, import and have imported
Antisense Products. These rights shall only be sublicensable as explicitly
provided in Section 2.2.
(b) Limited License Grant to Hybridon Excluded Patent Rights.
Subject to the terms and conditions of this Agreement, including without
limitation Hybridon's retained rights under Section 2.3 and Section 2.5(a) of
this Agreement, Hybridon hereby grants to Isis and its Subsidiaries the limited
worldwide licenses or sublicenses, as applicable, under the Hybridon Excluded
Patent Rights to practice Antisense Technology and to discover, develop, make,
have made, use, sell, have sold, offer to sell, import and have imported
Antisense Products, in each case solely to the extent specifically described
below. These rights shall only be sublicensable as explicitly provided in
Section 2.2.
(i) [*]
(ii) [*]
(iii) under the Immune Stimulation Patent Rights (A) to discover,
develop, make, have made, use, sell, have sold, offer to
sell, import and have imported Antisense Products which
contain modifications which have neutralized the immune
stimulation caused by an immunostimulatory CpG dinucleotide
in such Antisense Products, (B) to practice Antisense
Technology using oligonucleotides which contain
modifications which have neutralized the immune stimulation
caused by an immunostimulatory CpG dinucleotide in such
oligonucleotides, and (C) to discover, develop, make, have
made, use, sell, have sold, offer to sell, import and have
imported Antisense Products which target genes involved in
immunity modulation;
*Confidential Treatment Requested - 9 -
(iv) under the Facilitator Patent Rights to discover, develop,
make, have made, use, sell, have sold, offer to sell,
import and have imported Antisense Products and practice
Antisense Technology, provided that neither such Antisense
Products nor such Antisense Technology use, or are used
with, a Ribozyme or Ribozyme Technology;
(v) under the Finderon Patent Rights to discover, develop,
make, have made, use, sell, have sold, offer to sell,
import and have imported Antisense Products and practice
Antisense Technology, provided that neither such Antisense
Products nor such Antisense Technology use, or are used
with, a Ribozyme or Ribozyme Technology;
(vi) under the Amino Patent Rights to discover, develop, make,
have made, use, sell, have sold, offer to sell, import and
have imported Antisense Products and practice Antisense
Technology, provided that such Antisense Products and
Antisense Technology use, or are used with, the technology
covered by the claims of the Amino Patent Rights solely for
the conjugation of functional groups for therapeutic or
prophylactic purposes only;
(vii) under the Drug Potentiation Patent Rights to discover,
develop, make, have made, use, sell, have sold, offer to
sell, import and have imported Antisense Products and
practice Antisense Technology, which Antisense Products and
Antisense Technology primarily act against a gene target
implicated in cancer through an antisense mechanism, but
which may incidentally potentiate an anti-cancer prodrug;
and
(viii) under the Exhibit K Patents to discover, develop, make,
have made, use, sell, have sold, offer to sell, import and
have imported Antisense Products and practice Antisense
Technology; provided, however, that the license
contemplated by this clause (viii) shall not extend to
Antisense Products or Antisense Technology related to
specific claimed gene targets or pseudo-cyclic
oligonucleotide structures and applications.
The Parties agree that if, during the term of the license and sublicense
granted by Hybridon to Isis and its Subsidiaries in this Section 2.1(b), a claim
- 10 -
issues from any patent application included in Hybridon Excluded Patent Rights
that is necessary or useful for the practice of Antisense Technology, Hybridon
shall not use such claim to preclude or otherwise interfere with the ability of
Isis or its Subsidiaries to discover, develop, make, have made, use, sell, have
sold, offer to sell, import and have imported Antisense Products and practice
Antisense Technology; provided, however, that to the extent that the license or
sublicense grant set forth above in this Section 2.1(b) is limited in scope as
to its application to Antisense Products or Antisense Technology, such
limitation shall also be applicable to the restrictions on Hybridon's rights to
preclude or otherwise interfere with Isis and its Subsidiaries set forth in this
paragraph (i.e., if the license or sublicense grant is not applicable, Hybridon
shall not be restricted from precluding or interfering).
(c) The licenses and sublicenses granted by Hybridon to Isis
and its Subsidiaries in Sections 2.1(a) and (b) to the extent such
licenses or sublicenses cover UMass Patent Rights are subject to, without
limitation Sections 2.2(a), 2.2(b), 2.2(d), 2.6, 2.7, 4.3(a), 4.3(d), 7.1,
10.4 and 12.4(a) of the License Agreement dated as of February 21, 1990
and restated as of September 8, 1993 by and between Hybridon and
University of Massachusetts Medical Center (formerly the Worcester
Foundation for Biomedical Research, Inc. and referred to herein as
"UMass") (the "UMass Agreement"). A copy of the UMass Agreement is
attached to this Agreement as EXHIBIT J. Hybridon hereby represents and
warrants as of the date hereof: (i) that Exhibit J is a true, correct and
complete copy of the UMass Agreement and all amendments and/or other
changes thereto, (ii) that the UMass Agreement is in full force and
effect, (iii) that Hybridon is not in default thereunder and (iv) that
there has been no waiver of rights by Hybridon thereunder. Hybridon
further represents and warrants as of the date hereof that Isis shall have
no payment obligation to UMass arising out of the execution and delivery
of this Agreement or the sublicensing by Hybridon of the UMass Patent
Rights hereby and that any payment obligations that do arise under the
UMass Agreement shall be the sole responsibility of Hybridon; provided
that Isis may have payment obligations to UMass directly in the case of a
termination of the UMass Agreement pursuant to the last paragraph of
Section 2.2(c) of the UMass Agreement.
Section 2.2 SUBLICENSING RIGHT.
(a) Isis and its Subsidiaries shall have the right to grant
sublicenses under the licenses and sublicenses from Hybridon set forth in
Section 2.1 above to third parties. Each such sublicense shall be subject
and subordinate to, and consistent with, the terms and conditions of this
Agreement, and shall provide that any Sublicensee shall have no right to
grant further sublicenses except on terms consistent with this Section
2.2. In the event of a material default by any
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Sublicensee under a sublicense agreement, Isis will inform Hybridon and
take commercially reasonable efforts to cause the Sublicensee to cure
the default or will terminate the sublicense or, if Isis is not the
sublicensor under such sublicense, Isis will cause the sublicensor under
such sublicense to take commercially reasonable efforts to cause the
Sublicensee to cure the default or to terminate such sublicense; provided,
however that none of Isis, its Subsidiaries or the sublicensor under such
sublicense shall be responsible to Hybridon for the default by the
Sublicensee under the sublicense agreement.
(b) (i) Isis shall provide UMass with a copy of any sublicense
granted pursuant to this Section 2.2 by Isis or its Subsidiaries or
Sublicensees which includes a sublicense of UMass Patent Rights, within
thirty (30) days after the grant of such sublicense. Hybridon shall use
its reasonable best efforts to cause UMass to enter into a confidentiality
agreement with Isis with respect to sublicenses provided to UMass under
this clause (i) (it being understood that Hybridon shall not be obligated
to make any payment or to provide any other consideration to UMass for
such confidentiality agreement by UMass).
(ii) Isis shall provide Hybridon with written notice of
any sublicense (an "Isis Sublicense") granted pursuant to this Section 2.2 by
Isis or its Subsidiaries or Sublicensees within thirty (30) days after the grant
of such sublicense, such written notice specifying the name of the Sublicensee,
the date of the sublicense and whether such Isis Sublicense includes UMass
Patent Rights or is a Naked Sublicense. Hybridon shall have the right, not more
than twice during any calendar year, to have any Isis Sublicense reviewed by an
independent third party chosen by Hybridon to ascertain whether such Isis
Sublicense includes UMass Patent Rights or is a Naked Sublicense. Isis shall
cooperate in all reasonable respects with the review of such Isis Sublicense by
the independent third party under this Section 2.2(b)(ii), including without
limitation responding to questions directed at determining whether such Isis
Sublicense includes UMass Patent Rights or is a Naked Sublicense. Hybridon shall
pay all costs of such review; provided, however, that if, contrary to the
information provided by Isis in the written notice provided to Hybridon in
connection with the grant of such Isis Sublicense, such Isis Sublicense does in
fact include UMass Patent Rights or is a Naked Sublicense, Isis shall reimburse
Hybridon for the costs of such review. If the independent third party determines
that such Isis Sublicense includes UMass Patent Rights or is a Naked Sublicense,
such independent third party shall notify Isis and Hybridon. If Isis disagrees
with the determination of the independent third party, the third party shall be
permitted hereunder to provide Hybridon with a copy of the Isis Sublicense.
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(c) Any Naked Sublicense of Hybridon Intellectual Property by
Isis or its Subsidiaries to (i) third parties which are parties to license
or sublicense agreements with Isis or its Affiliates or Subsidiaries not
involving Hybridon Intellectual Property and (ii) Affiliates of Isis or
its Subsidiaries shall be made by Isis or its Subsidiaries on commercially
reasonable terms. Isis and its Subsidiaries shall not sublicense Hybridon
Intellectual Property separately from any intellectual property of Isis or
its Affiliates or Subsidiaries, including without limitation the Isis
Intellectual Property, for the purpose of reducing the amount of
Sublicense Income payable by Isis or its Subsidiaries to Hybridon under
Section 4.3.
Section 2.3 NO IMPLIED LICENSES; RETAINED RIGHTS. Other than those rights
and licenses explicitly granted herein, no right or license under the Hybridon
Intellectual Property is granted to Isis or its Subsidiaries or Sublicensees.
Notwithstanding the rights and licenses granted herein, Hybridon shall retain
its rights under the Hybridon Intellectual Property for all purposes, including
without limitation its rights to discover, develop, make, have made, use, sell,
have sold, offer to sell, import and have imported Antisense Products, to
practice Antisense Technology and to license or sublicense Hybridon Intellectual
Property; provided, that, except for licenses and sublicenses provided under the
Third Party License Agreements, Hybridon and its Subsidiaries shall not grant
any Naked Sublicenses of the Hybridon Antisense Patent Rights to any third
parties (other than Subsidiaries).
Section 2.4 COMMERCIALIZATION EFFORTS. Isis hereby agrees to undertake
reasonable efforts to bring one or more products covered by a claim of the UMass
Patent Rights into commercial use as quickly as is reasonably possible.
Section 2.5 LICENSE AGREEMENTS TO WHICH HYBRIDON IS A PARTY.
(a) Notwithstanding Section 2.1 of this Agreement, Hybridon
shall not and is not licensing or sublicensing to Isis or its Subsidiaries
any rights under the Hybridon Intellectual Property to the extent that
such Hybridon Intellectual Property has been licensed or sublicensed by
Hybridon under the Third Party License Agreements.
(b) Hybridon hereby represents and warrants as of the date
hereof that, except for the agreements set forth on EXHIBIT H-2 attached
hereto: (i) Hybridon has not entered into any agreement under which it has
licensed from another party any of the Hybridon Intellectual Property and
(ii) Hybridon has not entered into any agreement under which it has
licensed to another party any of the Hybridon Intellectual Property other
than the Third Party License Agreements.
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(c) Hybridon agrees that it shall not amend or expand any
Third Party License Agreement in a manner that is inconsistent with this
Agreement, including without limitation amending any Third Party License
Agreement to grant any new exclusive license under the Hybridon Antisense
Patent Rights, without the prior written consent of Isis, which consent
shall not be unreasonably withheld or delayed.
(d) Hybridon hereby represents and warrants as of the date
hereof as to the Third Party License Agreements: (i) that it has provided
true
- 14 -
and correct copies of all such agreements to Isis, (ii) that all such
agreements are in full force and effect, (iii) that Hybridon is not in
default under any such agreement and (iv) that there has been no waiver of
rights by Hybridon thereunder.
Section 2.6 METHYLGENE LICENSE AGREEMENT. If Methylgene Inc.
("Methylgene") designates a target which Methylgene desires to select as a
Second Molecular Target or a Third Molecular Target (as such terms are defined
in the Amended and Restated License Agreement made effective as of January 4,
1996, as amended and restated on September 21, 2000 (the "Methylgene License
Agreement")) pursuant to the terms of the Methylgene License Agreement [*].
Section 2.7 ORIGENIX LICENSE AGREEMENT. Hybridon shall [*] License
Agreement dated as of January 22, 1999 (the "OriGenix License Agreement")
between Hybridon and OriGenix Technologies Inc. ("OriGenix")) and shall [*]
Section 2.8 AFFILIATES. Hybridon hereby represents and warrants as of the
date hereof that no Affiliate of Hybridon owns or controls any patents, patent
applications or inventions invented, licensed or sublicensed by such Affiliate
prior to April 26, 2001 which are necessary or useful to practice Antisense
Technology.
ARTICLE III
GRANT OF RIGHTS BY ISIS
Section 3.1 LICENSE GRANT. Subject to the terms and conditions of this
Agreement, Isis hereby grants to Hybridon and its Subsidiaries a worldwide
non-exclusive license or sublicense, as applicable under the Isis Intellectual
Property Rights to discover, develop, make, have made, use, sell, have sold,
offer to sell, import and have imported Hybridon Antisense Drugs. These rights
shall only be sublicensable as explicitly provided in Section 3.2.
Section 3.2 SUBLICENSING RIGHT. Hybridon and its Subsidiaries shall have
the right to grant sublicenses under the license from Isis set forth in Section
3.1 above to third parties only to discover, develop, make, have made, use,
sell, have sold, offer to sell, import and have imported Hybridon Antisense
Drugs. Each such sublicense shall be subject and subordinate to, and consistent
with, the terms and conditions of this Agreement, and shall provide that any
Sublicensee shall have no right to grant further sublicenses except on
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terms consistent with this Section 3.2. In the event of a material default by
any Sublicensee under a sublicense agreement, Hybridon will inform Isis and
take commercially reasonable efforts to cause the Sublicensee to cure the
default or will terminate the sublicense or, if Hybridon is not the sublicensor
under such sublicense, Hybridon will cause the sublicensor under such
sublicense to take commercially reasonable efforts to cause the Sublicensee
to cure the default or to terminate such sublicense; provided however that none
of Hybridon, its Subsidiaries or the sublicensor under such sublicense shall
be responsible to Isis for the default by the Sublicensee under the sublicense
agreement. Notwithstanding the rights granted under this Section 3.2, Hybridon
and its Subsidiaries shall [*]
Section 3.3 XXXXXX PATENTS.
(a) Subject to the terms and conditions of this Agreement,
Isis hereby grants to Hybridon and its Subsidiaries a worldwide
non-exclusive sublicense, with the right to grant sublicenses as provided
in Section 3.3(b), under the Xxxxxx Patents to discover, develop, make,
have made, use, sell, have sold, offer to sell, import and have imported
Hybridon Antisense Drugs, provided that such Hybridon Antisense Drugs
employ technology covered by the Isis Intellectual Property as a material
element thereof.
(b) (i) Hybridon and its Subsidiaries shall have the right to
grant sublicenses under the license from Isis set forth in Section 3.3(a)
to third parties (x) provided that such sublicense may only be granted to
third parties in connection with the grant of a sublicense to such third
parties of Isis Intellectual Property under Section 3.2, and (y) solely to
discover, develop, make, have made, use, sell, have sold, offer to sell,
import and have imported Hybridon Antisense Drugs that employ technology
covered by the Isis Intellectual Property as a material element thereof.
Each such sublicense shall be subject and subordinate to, and consistent
with, the terms and conditions of this Agreement, and shall provide that
any such Sublicensee shall have no right to grant further sublicenses
except on terms consistent with this Section 3.3(b).
(ii) Hybridon shall provide MBI with a copy of any
sublicense granted by Hybridon or its Subsidiaries or Sublicensees pursuant to
this Section 3.3(b) within thirty (30) days after the grant of such sublicense.
Isis shall use its reasonable best efforts to cause MBI to enter into a
confidentiality agreement with Hybridon with respect to sublicenses provided to
MBI under this Section 3.3(b) (it being understood that Isis shall not be
obligated to make any payment or to provide any other consideration to MBI for
such confidentiality agreement by MBI). In the event that MBI does not sign such
a confidentiality agreement with Hybridon, Isis shall enforce against MBI, for
and on behalf of Hybridon, the confidentiality provisions of the Xxxxxx
*Confidential Treatment Requested - 15 -
Agreement with respect to the sublicenses provided by Hybridon, its Subsidiaries
or Sublicensees to MBI and with respect to any other confidential information
of Hybridon or a Subsidiary or Sublicensee of Hybridon that MBI receives.
(iii) In the event of a material default by any
Sublicensee under a sublicense agreement pursuant to this Section 3.3(b),
Hybridon will inform Isis and take commercially reasonable efforts to cause the
Sublicensee to cure the default or will terminate the sublicense, or if Hybridon
is not the sublicensor under such sublicense, Hybridon will cause the
sublicensor under such sublicense to take commercially reasonable efforts to
cause the Sublicensee to cure the default or to terminate such sublicense;
provided however that none of Hybridon, its Subsidiaries or the sublicensor
under such sublicense shall be responsible to Isis for the default by the
Sublicensee under the sublicense agreement. Notwithstanding the rights granted
under this Section 3.3(b), Hybridon shall [*]
(c) A copy of the Xxxxxx Agreement is attached to this
Agreement as EXHIBIT N. Isis hereby represents and warrants as of the date
hereof: (i) that Exhibit N is a true, correct and complete copy of the
Xxxxxx Agreement and all amendments and/or other changes thereto that
affect the rights of Hybridon as a sublicensee thereunder, (ii) that the
Xxxxxx Agreement is in full force and effect, (iii) that Isis is not in
default thereunder and (iv) that there has been no waiver of rights by
Isis thereunder. Isis further represents and warrants as of the date
hereof that Hybridon shall have no payment obligation to MBI arising out
of the execution and delivery of this Agreement or the sublicensing by
Isis of the Xxxxxx Patents hereby and that any payment obligations that do
arise shall be the sole responsibility of Isis.
Section 3.4 SCOPE OF LICENSE. Hybridon acknowledges that Isis claims
intellectual property covering numerous chemical modifications to
oligonucleotides including without limitation modifications to backbone
linkages, sugars, heterocyclic bases and conjugates and to methods of making the
same, including methods of making various oligonucleotide intermediates (the
"Isis Chemistry Intellectual Property"). Hybridon acknowledges and agrees that
no Isis Chemistry Intellectual Property is included in the Isis Intellectual
Property being licensed or sublicensed to Hybridon and its Subsidiaries pursuant
to Section 3.1 of this Agreement, except as expressly set forth below in this
Section 3.4. [*] Isis hereby agrees that any patents owned or controlled by
Isis or an Affiliate as of the date hereof or any patents that may issue in the
future to Isis or an Affiliate from or in respect of any patent applications
which Isis or an Affiliate owned or had the right to sublicense as of April 26,
2001, which would otherwise be infringed by the practice of the Hybridon 2'-O
Methyl Chemistry, shall constitute Isis Intellectual Property for all purposes
of this Agreement, including without limitation the license grant provided in
Section
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3.1; provided, however, that the license grant with respect to such patents
shall only provide Hybridon and its Subsidiaries with the right to discover,
develop, make, have made, use, sell, have sold, offer to sell, import and have
imported Hybridon Antisense Drugs which incorporate the Hybridon 2'-O
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Methyl Chemistry. If any patent of Isis or an Affiliate includes claims to a
combination of modifications to both substitution with 2'-O-methyl and Isis
Chemistry Intellectual Property in addition to 2'-O-methyl substituents, nothing
in this Section 3.4 shall be deemed to be a grant of rights to Hybridon or its
Subsidiaries to practice the Isis Chemistry Intellectual Property other than
2'-O-methyl substituents.
Section 3.5 NO IMPLIED LICENSES. Other than those rights and licenses
explicitly granted herein, no right or license under the Isis Intellectual
Property or the Xxxxxx Patents is granted to Hybridon or its Subsidiaries or
Sublicensees.
Section 3.6 LIMITATION ON LICENSE GRANT WITH RESPECT TO TARGET VALIDATION
AND GENE FUNCTIONALIZATION ACTIVITIES. Notwithstanding anything to the contrary
in Sections 3.1 and 3.3(a), the licenses set forth in Sections 3.1 and 3.3(a)
above do not grant Hybridon and its Subsidiaries the right:
(a) to use the Isis Intellectual Property and the Xxxxxx
Patents for target validation and gene functionalization activities,
except when, and only to the extent that, (i) such activities are directed
to the discovery, development, Optimization and commercialization of a
Hybridon Antisense Drug and (ii) such activities are performed only by
Hybridon or a Subsidiary and not by a contractor or a collaborator, or
(b) to use, or enable any third party to use, any information
that is developed during such target validation and gene functionalization
activities in the development of a drug other than a Hybridon Antisense
Drug, including without limitation, small molecules, ribozymes, proteins
and pseudocyclic oligonucleotide structures.
Section 3.7 NOTICE OF HYBRIDON ANTISENSE DRUGS. Hybridon shall provide
Isis with written notice of any Hybridon Antisense Drugs developed under a
sublicense granted by Hybridon or its Subsidiaries under Section 3.2 (a
"Hybridon Antisense Drug Sublicense") promptly after such Hybridon Antisense
Drug is developed. Isis shall have the right, not more than twice during any
calendar year, to have any Hybridon Antisense Drug Sublicense reviewed by an
independent third party chosen by Isis to confirm whether such Hybridon
Antisense Drug qualifies as a Hybridon Antisense Drug as defined under this
Agreement. Hybridon shall cooperate in all reasonable respects with the review
of such Hybridon Antisense Drug Sublicense by the independent third party under
this Section 3.6, including without limitation responding to questions directed
at determining whether such Hybridon Antisense Drug qualifies as a Hybridon
Antisense Drug. Isis shall pay all costs of such review; provided, however, that
if such Hybridon Antisense Drug does not qualify as a Hybridon Antisense Drug as
defined under this Agreement, Hybridon shall reimburse Isis for the costs of
such review. If the independent third party determines that such Hybridon
Antisense Drug does not qualify as
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a Hybridon Antisense Drug as defined under this Agreement, such independent
third
- 18 -
party shall notify Hybridon and Isis. If Hybridon disagrees with the
determination of the independent third party, the third party shall be permitted
to provide Isis with a copy of the Hybridon Antisense Drug Sublicense.
Section 3.8 AFFILIATES. Isis hereby represents and warrants as of the date
hereof that no Affiliate of Isis owns or controls any patents, patent
applications or inventions invented, licensed or sublicensed by such Affiliate
prior to April 26, 2001 which cover or claim Motifs or RNaseH Dependent
Mechanisms of Action.
ARTICLE IV
PAYMENT OBLIGATIONS
Section 4.1 CONSIDERATION FOR LICENSES OF HYBRIDON INTELLECTUAL PROPERTY
AND ISIS INTELLECTUAL PROPERTY. In consideration of the licenses and sublicenses
granted under Sections 2.1 and 3.1 of this Agreement and the restrictions on use
agreed to by Hybridon under this Agreement, Hybridon and Isis each shall pay to
the other the consideration set forth in the Master Agreement and Section 4.2
and Section 4.3 of this Agreement. Isis and Hybridon each recognizes that the
other Party has expended significant efforts and resources in the research and
development of Antisense Technology and the payments to be made under the Master
Agreement to each Party for the patent licenses and sublicenses granted
hereunder will allow each Party to recoup such expenditures.
Section 4.2 CONSIDERATION FOR SUBLICENSE OF XXXXXX PATENTS. In
consideration of the sublicense granted by Isis to Hybridon under Section 3.3 of
this Agreement, Hybridon shall pay to Isis the annual maintenance fee and
royalties provided below:
(a) On the date hereof and each anniversary of such date
thereafter (until the earlier of the termination of the sublicense grant
under Section 3.3 or the date on which there ceases to be any Valid Claims
included in the Xxxxxx Patents), an annual maintenance fee of [*]
(b) Hybridon shall pay to Isis earned royalties at the rate of
[*] of Xxxxxx Net Sales of Xxxxxx Products. Hybridon shall be obligated
to pay such royalties on a country-by-country basis, so long as there
continues to be a Valid Claim included in the Xxxxxx Patents which covers
the manufacture, use or sale of the applicable Xxxxxx Product in such
country. During the term of the sublicense under Section 3.3 and for so
long thereafter as Hybridon is required to report royalties payable under
this Section 4.2, Hybridon shall deliver to Isis within thirty (30) days
after March 31, June 30, September 30 and December 31 of each year a
report indicating (i) Xxxxxx Net Sales for each Xxxxxx Product, on a
Xxxxxx
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Product-by-Xxxxxx Product and country-by-country basis, including an
accounting of the deductions from Xxxxxx Net Sales permitted by the
definition thereof and (ii) total royalties owed. Simultaneously with the
delivery of each such report, Hybridon shall pay to Isis the royalty
payments due under this Agreement for the period covered by such report.
If no royalties are due, it shall be so reported.
Section 4.3 ISIS SUBLICENSE INCOME. Isis shall pay to Hybridon [*] of all
Sublicense Income, [*] in respect of Sublicense Income received in connection
with a Naked Sublicense [*]. Such payment by Isis shall be paid to Hybridon
within 30 days after the calendar quarter in which the Sublicense Income was
received by Isis or a Subsidiary. Isis shall deliver to Hybridon with such
payment a report describing such Sublicense Income and how such Sublicense
Income was calculated, all on a country-by-country and product-by-product basis.
Section 4.4 RECORDS; AUDITS. For a period not less than three (3) years
after the relevant period, each Party shall keep full, true and accurate books
of account sufficient to determine the amounts payable pursuant to Section
4.2(b) or 4.3, as the case may be. Each Party shall have the right, not more
than once during any calendar year, to have the books and records of the other
Party audited by a qualified independent accounting firm of its choosing, under
appropriate confidentiality provisions, to ascertain the accuracy of the reports
and payments hereunder and compliance by the other Party and its Subsidiaries
and Sublicensees with their obligations under Section 4.2(b) or 4.3, as the case
may be. Such audit shall be conducted upon at least ten (10) days' advance
notice during normal business hours and in a manner that does not interfere
unreasonably with the business of the audited entity. Any underpayment or
overpayment determined by such audit shall promptly be paid or refunded by
Hybridon or Isis, as the case may be. If a Party has underpaid an amount due
under Section 4.2(b) or 4.3, as the case may be, by more than five percent (5%),
such Party shall also reimburse the other Party for the cost of such audit (with
the cost of the audit to be paid by the other Party in all other cases).
Section 4.5 PAYMENT CURRENCY. All amounts due under this Agreement shall
be paid to the designated Party in United States currency by wire transfer to an
account in a United States bank specified by such Party or in such other form
and/or manner as such Party may reasonably request. The payments due on sales in
currencies other than United States dollars shall be calculated using the
appropriate exchange rate of such currency quoted in the Wall Street Journal on
the close of business on the last business day prior to which such payment is
made.
Section 4.6 LATE PAYMENTS; COLLECTIONS. Any amount not paid when due under
this Agreement or the Master Agreement shall bear interest at the lesser
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of (i) one and one-half percent (1.5%) per month, compounded monthly, or (ii)
the highest rate permitted by law. Each Party agrees to pay all costs of
collection, including reasonable attorneys' fees, incurred by the other Party in
enforcing the payment obligations of the first Party under this Agreement and
the Master Agreement.
ARTICLE V
COLLABORATION
In addition to the collaboration between the Parties with respect to
intellectual property protection under Article VI, the Parties shall further
collaborate hereunder through a committee (the "Collaboration Committee")
consisting of two representatives of each Party. The Parties shall establish the
Collaboration Committee within thirty (30) days after the Effective Date. The
Collaboration Committee shall meet at least twice each calendar year in person
or by video conference during the term of this Agreement to review the progress
of Isis' development efforts with respect to Isis' Antisense Products that are
covered by Hybridon Intellectual Property. The Parties intend that the
Collaboration Committee shall act as a forum for the Parties to work
cooperatively [*] The Parties also anticipate that the Collaboration Committee
may recommend to the Parties from time to time that certain aspects of the drug
development process be performed by Hybridon for Isis or that the Parties
consider entering into further collaborations. Neither Party shall be bound by
any recommendation of the Collaboration Committee but shall consider its
recommendations in good faith. In addition, neither Party shall be obligated to
disclose any Confidential Information to the Collaboration Committee.
ARTICLE VI
INTELLECTUAL PROPERTY PROTECTION
Section 6.1 Patent Prosecution and Cooperation.
(a) PROSECUTION AND MAINTENANCE OF HYBRIDON ANTISENSE PATENT
RIGHTS.
(i) Hybridon will be responsible for prosecuting and
maintaining the Hybridon Antisense Patent Rights. Hybridon shall promptly
forward to Isis' patent counsel any substantive actions prepared for or received
from the U.S. Patent and Trademark Office or any foreign patent office which may
materially affect patent rights, e.g., claim scope or patent term. Isis' patent
counsel shall provide any comments to Hybridon in sufficient time for Hybridon
to reflect such comments in any response. Any comments made by Isis shall be
made in good faith and shall be directed to maximizing the claims covered by the
Hybridon Antisense Patent Rights.
(ii) If Hybridon agrees with the comments of Isis' patent
counsel, it shall reflect such comments in its response. If Hybridon
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disagrees with such comments, it shall notify Isis, and either Party may then
submit such dispute (a "Patent Comment Dispute") for resolution by an
intellectual property lawyer (the "Neutral Lawyer") with at least five years of
experience and a background in biotechnology or pharmaceutical patent matters.
The Neutral Lawyer shall be selected by mutual agreement of the Parties;
provided, however, that if the Parties
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cannot agree on a Neutral Lawyer within five days of a Party's request for a
Neutral Lawyer under this provision, the Neutral Lawyer shall be selected by the
American Arbitration Association in Washington, D.C. Each Party shall submit its
position as to the Patent Comment Dispute to the Neutral Lawyer, who shall
resolve the dispute by agreeing to one of the submitted positions of the Parties
without any changes to such position. The Parties agree that the position agreed
to by the Neutral Lawyer shall be reflected in the action or response being
prepared and that the costs of the Neutral Lawyer shall be paid by the Party
whose position is not agreed to by the Neutral Lawyer. The decision of the
Neutral Lawyer shall be final and binding on the Parties. In light of the
foregoing dispute resolution mechanism, neither Party shall submit a Patent
Comment Dispute to binding arbitration in accordance with the provisions of
Article VIII. The Parties shall cooperate in all respects to resolve any Patent
Comment Dispute in sufficient time to avoid any loss of rights, including
without limitation jointly instructing the Neutral Lawyer to make a decision in
sufficient time to avoid any loss of rights.
(iii) Isis will be responsible for and pay fifty percent
(50%) of Hybridon's costs incurred in prosecuting and maintaining the Hybridon
Antisense Patent Rights, net of amounts paid to Hybridon for such costs by other
licensees and not including any costs of Hybridon incurred in connection with a
Patent Comment Dispute (except as otherwise specified in the foregoing Section
6.1(a)(ii)). Hybridon shall direct its counsel to invoice Isis directly for
Isis' share of such costs as such costs are incurred.
(b) JOINT PATENT COMMITTEE. Hybridon and Isis will, within
sixty (60) days after the execution of this Agreement, establish a
committee (the "Joint Patent Committee") consisting of three
representatives of each Party. The Joint Patent Committee shall confer
twice each calendar year or as necessary to support timely decision making
during the term of this Agreement to discuss patent prosecution issues,
budgets and strategies relating to the Hybridon Antisense Patent Rights.
The Joint Patent Committee shall also, as set forth in Section 5.2(b),
determine which Party faces the greatest competitive threat in the event
of infringement by a third party of any of the Hybridon Antisense Patent
Rights. In the event that the Joint Patent Committee is unable to resolve
any matter presented for resolution,. either Party shall have the right to
submit such matter to binding arbitration in accordance with the
provisions of Article VIII.
(c) INTERFERENCE BETWEEN ISIS INTELLECTUAL PROPERTY AND
HYBRIDON ANTISENSE PATENT RIGHTS. If an interference is declared between
any of the Isis Intellectual Property and any of the Hybridon Antisense
Patent Rights (other than the UMass Patent Rights), each Party shall be
represented by its own counsel in the interference proceedings; provided,
however, that Hybridon's counsel shall be jointly selected by Isis and
- 21 -
Hybridon; and provided further that if Hybridon and Isis can not agree on
counsel for Hybridon, a patent lawyer with at least five years of
experience in interference practice and a background in biotechnology or
pharmaceutical patent matters shall be selected to represent Hybridon by
the American Arbitration Association in Washington, D.C. Each Party shall
seek to resolve the interference in a manner that maximizes the value to
both parties of the combined portfolio of the Hybridon Antisense Patent
Rights and the Isis Intellectual Property. If an interference is declared
between any UMass Patent Rights and any Isis Intellectual Property,
Hybridon will cooperate with Isis in the resolution thereof to the extent
permitted under the UMass Agreement or, if Hybridon cannot so cooperate
due to obligations to UMass, Isis will not be obligated to reimburse
Hybridon for any expenses related to the interference proceedings. If an
interference is declared between any of the Hybridon Antisense Patent
Rights and the intellectual property of a third party or between any of
the Isis Intellectual Property and the intellectual property of a third
party, then Hybridon or Isis, as the case may be, shall have sole control
of prosecuting the interference.
(d) PATENT COOPERATION. Isis hereby represents and warrants as
of the date hereof that since April 26, 2001, neither Isis nor any of its
Affiliates has challenged, opposed or taken any action to provoke any
interference with any Hybridon Intellectual Property, and Isis agrees that
from and after the date of this Agreement Isis shall not, and shall cause
its Non-Parent Affiliates to not, challenge, oppose or take any action to
provoke any interference with, or maintain any current challenge or
opposition to, any Hybridon Intellectual Property. Hybridon hereby
represents and warrants as of the date hereof that since April 26, 2001,
neither Hybridon nor any of its Affiliates has challenged, opposed or
taken any action to provoke any interference with any Isis Intellectual
Property, and Hybridon agrees that from and after the date of this
Agreement Hybridon shall not, and shall cause its Non-Parent Affiliates to
not, challenge, oppose or take any action to provoke any interference
with, or maintain any current challenge or opposition to, any Isis
Intellectual Property. Hybridon further agrees that it will not use any
Hybridon Antisense Patent Rights to challenge or interfere with any
patents owned by Isis arising out of inventions invented, licensed or
sublicensed by Isis prior to April 26, 2001, including those included in
the Isis Intellectual Property, and that Hybridon will not oppose any
patents claiming inventions invented, licensed or sublicensed by Isis
prior to April 26, 2001, including those included in the Isis Intellectual
Property, that cover chemical modifications to antisense oligonucleotides.
The foregoing obligations not to challenge, oppose or interfere include,
without limitation obligations not to directly or indirectly provoke an
interference, participate in an opposition or make any claims of
invalidity; PROVIDED THAT either Party and its Affiliates may raise a
claim
- 22 -
of invalidity as a defense in a lawsuit filed by the other Party or its
Affiliates. In addition, in the context of any interference between any of
the Isis Intellectual Property and any of the Hybridon Antisense Patent
Rights provoked by the U.S. Patent and Trademark Office, the Parties shall
use commercially reasonable efforts to reach a settlement that maximizes
the value to both Parties of the combined portfolio of the Hybridon
Antisense Patent Rights and the Isis Intellectual Property.
(e) Notwithstanding any provision of this Section 6.1 to the
contrary, nothing in this Section 6.1 shall (x) prevent Hybridon from
complying with its obligations with respect to the Hybridon Intellectual
Property under the UMass Agreement or the Third Party License Agreements,
as applicable, or (y) limit the rights of the third parties under such
agreements with respect to the Hybridon Intellectual Property, including
as to clauses (x) and (y):
(i) UMass' right to prepare, file, prosecute and maintain certain
patents and patent applications in the name of UMass pursuant to
Section 8.1 of the UMass Agreement;
(ii) Hybridon's obligation to use counsel acceptable to UMass
and to consult with UMass regarding the preparation, filing,
prosecution or maintenance of certain patents and patent
applications pursuant to Section 8.1 of the UMass Agreement;
(iii) Hybridon's obligation pursuant to Section 8.2 of the
UMass Agreement (A) to provide notice to UMass prior to abandoning,
or failing to make payment or take other necessary actions to
maintain, certain patents and patent applications and (B) to
continue the prosecution or maintenance of such patents after notice
has been provided and before UMass has had sufficient time to assume
the prosecution or maintenance of such patent;
(iv) Methylgene's right under Section 5.5 of the Methylgene License
Agreement to take measures to ensure the registration and
maintenance of certain patents and patent applications if Hybridon
fails to register and maintain such patents and patent applications;
(v) Methylgene's right under Section 5.5 of the Methylgene License
Agreement to (A) approve the patent agent selected to prosecute
certain patents and patent applications, (B) be kept informed
regarding progress or problems related to certain patents and patent
applications and (C) have its comments on such progress or problems
be considered;
- 23 -
(vi) OriGenix's right under Section 5.5 of the OriGenix License
Agreement to take measures to ensure the registration and
maintenance of certain patents and patent applications if Hybridon
fails to register and maintain such patents and patent applications;
(vii) OriGenix's right under Section 5.5 of the OriGenix License
Agreement to (A) approve the patent agent selected to prosecute
certain patents and patent applications, (B) be kept informed
regarding progress or problems related to certain patents and patent
applications and (C) have its comments on such progress or problems
be considered;
(viii) EpiGenesis' right pursuant to Section 6.2.2 of the
Development and License Agreement between EpiGenesis
Pharmaceuticals, Inc. and Hybridon, dated as August 9, 2000 (the
"EpiGenesis License Agreement") to file, prosecute and maintain
certain patents and patent applications if Hybridon elects not to
continue to seek or maintain patent protection on such patents or
patent applications;
(ix) EpiGenesis' right pursuant to Section 6.2.2 of the EpiGenesis
License Agreement to (A) have Hybridon consult with EpiGenesis
regarding the prosecution of certain patents and patent
applications, (B) have a reasonable amount of time to consider and
comment on any document to be filed in connection with the
prosecution of such patents and patent applications and (c) have its
comments on such comments be seriously considered;
(x) Hybridon's obligation pursuant to Section 6.2.3 of the
EpiGenesis License Agreement (A) to provide notice to EpiGenesis
prior to abandoning, or failing to make payment or take other
necessary actions to maintain certain patents and patent
applications and (B) to continue the prosecution or maintenance of
such patents and patent applications after notice has been provided
and before EpiGenesis has had sufficient time to assume the
prosecution or maintenance of such patents and patent applications;
and
(xi) Boston Biosystems, Inc.'s (BBI) right and Avecia Holdings plc's
right to prosecute or maintain certain patents and patent
applications if Hybridon declines to prosecute or maintain such
patents or patent applications pursuant to (A) Section 4.03 of the
PNT Monomer Patent License and Option Agreement dated as of
September 20, 2000 by and between Hybridon and BBI, (B) Section 4.03
of the Oligonucleotide Purification Patent License Agreement
- 24 -
dated as of September 20, 2000 by and between Hybridon and BBI, and
(C) Section 5.03 of the Interference Patent Sublicense Option
Agreement dated as of September 20, 2000 by and between Hybridon and
BBI.
Section 6.2 ENFORCEMENT OF HYBRIDON ANTISENSE PATENT RIGHTS
(a) NOTICE. If Hybridon or Isis becomes aware that any of the
Hybridon Antisense Patent Rights is infringed by a third party or is
subject to a declaratory judgment action relating to infringement or
invalidity, Hybridon or Isis, as the case may be, shall promptly notify
the other Party.
(b) FIRST RIGHT OF ENFORCEMENT. In the event of infringement of
the Hybridon Antisense Patent Rights by a third party, the Party facing
the greatest competitive threat from the infringement shall have the first
right (but not the obligation), at its sole expense, to undertake such
action as it shall determine, in its discretion, appropriate to enforce
the Hybridon Antisense Patent Rights; provided, however, that such Party
shall not admit the invalidity or unenforceability of any Hybridon
Antisense Patent Rights, grant a license to the allegedly infringing third
party or enter into any settlement agreement without the other Party's
prior written consent. The determination of which Party faces the greatest
competitive threat from the infringement shall be made by the Joint Patent
Committee. If the Joint Patent Committee determines that neither Party
faces a greater competitive threat than the other Party, then Hybridon
shall have the first right to enforce the Hybridon Antisense Patent
Rights. The Party enforcing the Hybridon Antisense Patent Rights shall
keep the other Party reasonably informed on a quarterly basis, in person
or by telephone, prior to and during any such enforcement. The other Party
shall assist the Party enforcing the Hybridon Antisense Patent Rights,
upon the enforcing Party's request and at the enforcing Party's sole
expense, in taking any action to enforce the Hybridon Antisense Patent
Rights and shall join in any such action if deemed by a court of competent
jurisdiction to be a necessary party. Neither Party shall incur liability
to the other Party as a consequence of such litigation or any unfavorable
decision resulting therefrom, including any decision holding any of the
Hybridon Antisense Patent Rights invalid, not infringed or unenforceable.
Notwithstanding the foregoing, if Isis is the Party enforcing the Hybridon
Antisense Patent Rights under this Section 6.2(b) and such Hybridon
Antisense Patent Rights are included in the claims that are the subject
matter of the UMass Agreement or are licensed by Hybridon under the Third
Party License Agreements, Isis' rights to enforce such Hybridon Antisense
Patent Rights shall be limited to the rights of Hybridon to enforce such
Hybridon Antisense Patent Rights, and subject to and limited by the rights
of the other parties to the
- 25 -
UMass Agreement and the Third Party License Agreements, as set forth in
the UMass Agreement or the Third Party License Agreements, as applicable,
including:
(i) UMass's right pursuant to Section 9.2 of the UMass Agreement to
prosecute any infringements of certain patents and patent
applications licensed to Hybridon pursuant to the UMass Agreement;
(ii) Hybridon's obligation pursuant to Section 9.3 of the UMass
Agreement to seek the consent of UMass to any settlement, consent
judgement or other voluntary final disposition of a suit involving
certain patents and patent applications licensed to Hybridon
pursuant to the UMass License;
(iii) UMass' right to intervene and take over the sole defense of a
declaratory judgment action pursuant to Section 9.6 of the UMass
Agreement;
(iv) Methylgene's right pursuant to Section 5.1(b) of the Methylgene
License Agreement to initiate infringement actions related to
certain patents and patent applications as it may in its discretion
deem necessary or desirable;
(v) OriGenix's right pursuant to Section 5.1(v) of the OriGenix
License Agreement to initiate infringement actions related to
certain patents and patent applications as it may in its discretion
deem necessary or desirable; and
(vi) EpiGensesis' right pursuant to Section 6.6 of the EpiGenesis
License Agreement to initiate infringement actions related to
certain patents and patent applications and to consent to any
settlement of infringement litigation that would materially diminish
the rights of EpiGenesis in certain patents and patent applications.
Items (i) through (vi) of this Section 6.2(b) are collectively referred to as
the "Other Enforcement Rights".
(c) ENFORCEMENT BY OTHER PARTY. If the Party having the first
right to enforce the Hybridon Antisense Patent Rights pursuant to Section
5.2(b) above fails to file an action to xxxxx an infringement of the
Hybridon Antisense Patent Rights, within six (6) months after a written
request from the other Party to do so, or if such Party fails to
diligently prosecute or discontinues the prosecution of any such action,
the other Party at its sole expense may, in its discretion, undertake such
action as it determines appropriate (other than the grant of a license to
the allegedly infringing third party) to enforce such Hybridon Antisense
- 26 -
Patent Rights. Such other Party shall keep the Party that had the first
right to enforce the Hybridon Antisense Patent Rights reasonably informed
on a quarterly basis, in person or by telephone, prior to and during any
such enforcement. In such case, the Party that had the first right to
enforce the Hybridon Antisense Patent Rights shall assist such other
Party, upon such other Party's request and at such other Party's sole
expense, in taking any action to enforce the Hybridon Antisense Patent
Rights and shall join in any such action if deemed by a
court of competent jurisdiction to be a necessary party. Neither Party
shall incur liability to the other Party as a consequence of such
litigation or any unfavorable decision resulting therefrom, including any
decision holding any of the Hybridon Antisense Patent Rights invalid, not
infringed or unenforceable. Notwithstanding the foregoing, if Isis is the
Party enforcing the Hybridon Antisense Patent Rights under this Section
6.2(c) and such Hybridon Antisense Patent Rights are included in the
claims that are the subject matter of the UMass Agreement or are licensed
by Hybridon under the Third Party License Agreements, Isis' rights to
enforce such Hybridon Antisense Patent Rights shall be limited to the
rights of Hybridon to enforce such Hybridon Antisense Patent Rights, and
subject to and limited by the rights of the other parties to the UMass
Agreement and the Third Party License Agreements, as set forth in the
UMass Agreement or the Third Party License Agreements, as applicable,
including the Other Enforcement Rights.
(d) RECOVERIES. All monies recovered upon the final judgment
or settlement of any action involving the enforcement of Hybridon Antisense
Patent Rights as contemplated by this Section 6.2 shall be allocated in the
following order of priority: (i) first to reimburse the costs and expenses
(including reasonable attorney fees and costs) incurred by the Parties in
prosecuting such action, and (ii) any remaining portion of the recovery shall be
divided between the Parties in proportion to the respective total losses,
determined by aggregating both past and prospective losses, each Party would
have been reasonably likely to have suffered had such infringement continued
unabated. Notwithstanding the foregoing, if the Hybridon Antisense Patent Rights
that were the subject of the action are included in the claims that are the
subject matter of the UMass Agreement or are licensed by Hybridon under the
Third Party License Agreements, the provisions of this Section 6.2(d) shall only
apply to such monies recovered upon the final judgment or settlement of such
action as remain following payment of monies to third parties as required under
the UMass Agreement and the Third Party License Agreements.
ARTICLE VII
CONFIDENTIALITY
Section 7.1 CONFIDENTIAL INFORMATION. Each Party agrees that all
Confidential Information of a Party that is disclosed by a Party to the other
- 27 -
Party (a) shall be maintained in confidence by the receiving Party and shall not
be used by the receiving Party for any purpose other than as permitted under
this Agreement, and (b) shall not be disclosed by the receiving Party to any
third party who is not a Subsidiary of the receiving Party, or a consultant or
an advisor to the receiving Party or a Subsidiary of the receiving Party,
without the prior written consent of the disclosing Party; provided, however,
that Confidential Information may only be disclosed by the receiving Party to
Subsidiaries or consultants or advisors to the receiving Party or its
Subsidiaries if such Subsidiaries, consultants or advisors, as the case may be,
have agreed in writing to be bound by the obligations of the
receiving Party under this Section 7.1. Notwithstanding the foregoing, the
receiving Party shall be entitled to use and disclose Confidential Information
that:
(a) was known or used by the receiving Party or its
Subsidiaries prior to its date of disclosure to the receiving Party as
demonstrated by legally admissible evidence available to the receiving
Party or its Subsidiaries; or
(b) either before or after the date of the disclosure to the
receiving Party is lawfully disclosed to the receiving Party or its
Subsidiaries by sources other than the disclosing Party rightfully in
possession of the Confidential Information and not bound by
confidentiality obligations to the disclosing Party or its Subsidiaries;
or
(c) either before or after the date of the disclosure to the
receiving Party is or becomes published or otherwise is or becomes part of
the public domain through no breach hereof on the part of the receiving
Party or its Subsidiaries; or
(d) is independently developed by or for the receiving Party
or its Subsidiaries without reference to or reliance upon the Confidential
Information as demonstrated by competent written records; or
(e) is reasonably necessary to conduct clinical trials or for
regulatory approval of products or for the filing, prosecution and
maintenance of patents and patent applications, PROVIDED THAT the
receiving Party provides prior written notice of such disclosure to the
disclosing Party and takes reasonable and lawful actions to avoid and/or
minimize the degree of such disclosure; or
(f) is required to be disclosed by the receiving Party to
comply with applicable laws, to defend or prosecute litigation or to
comply with governmental regulations, PROVIDED THAT the receiving Party
provides prior written notice of such disclosure to the disclosing Party
- 28 -
and takes reasonable and lawful actions to avoid and/or minimize the
degree of such disclosure.
ARTICLE VIII
DISPUTE RESOLUTION
Section 8.1 Except as set forth in Section 6.1(a)(ii), each Party must submit
any dispute under this Agreement or the Master Agreement to arbitration by
notifying the other Party, in writing, of such dispute. Within 30 days after
receipt of such notice, the Parties shall designate in writing one arbitrator to
resolve the dispute; PROVIDED, that if the Parties cannot agree on an arbitrator
within such 30 days period, the arbitrator shall be selected by the office of
the American
Arbitration Association in the city where arbitration will take place. The
arbitrator shall not be an employee, consultant, officer, director or
stockholder of any Party or its Affiliates. If neither the Parties nor the
applicable office of the American Arbitration Association is able to identify an
individual to serve as the arbitrator, the American Arbitration Association
shall select an arbitrator from the CPC Panel of Distinguished Neutrals of the
CPR Institute for Dispute Resolution.
Section 8.2 Within 30 days after the designation of the arbitrator, the
arbitrator and the Parties shall meet, at which time the Parties shall be
required to set forth in writing all disputed issues and a proposed ruling on
the merits of each such issue.
Section 8.3 The arbitrator shall set a date for a hearing, which shall be
no later than 45 days after the submission of written proposals to discuss each
of the issues identified by the Parties. Each Party shall have the right to be
represented by counsel. Except as provided herein, the arbitration shall be
governed by the Commercial Arbitration Rules of the American Arbitration
Association; PROVIDED, HOWEVER, that the Federal Rules of Evidence shall apply
with regard to the admissibility of evidence and the arbitration shall be
conducted by a single arbitrator.
Section 8.4 The arbitrator shall use his or her best efforts to rule on
each disputed issue within 30 days after the completion of the hearings. The
determination of the arbitrator as to the resolution of any dispute shall be
final and binding and conclusive upon all parties hereto. All determinations of
the arbitrator shall be in writing and shall be delivered to the Parties. The
determinations of the arbitrator may be entered in any court of competent
jurisdiction.
Section 8.5 The attorneys' fees of the Parties in any arbitration, the
fees of the arbitrator, and the costs and expenses of the arbitration
(collectively, the "Arbitration Costs") shall be borne by the Parties as
determined by the arbitrator.
- 29 -
Section 8.6 The arbitration shall take place in Boston, Massachusetts if
brought by Isis and in San Diego, California if brought by Hybridon.
Section 8.7 Nothing in this Article VIII shall prevent either Party from
seeking a preliminary injunction, temporary restraining order or similar relief
in order to prevent or limit and irreparable harm that might occur in the
absence thereof from a court of competent jurisdiction.
ARTICLE IX
TERM AND TERMINATION
Section 9.1 TERM. This Agreement shall commence as of the date hereof and
shall continue until the last of the patents and patent applications included in
the Hybridon Intellectual Property, the Isis Intellectual Property and the
Xxxxxx Patents has expired, subject to earlier termination of this Agreement in
accordance with this Article IX. Notwithstanding the foregoing, the licenses or
sublicenses granted hereunder shall terminate on a country-by-country basis
concurrently with the expiration or termination of the applicable Valid Claim
under the Hybridon Intellectual Property, the Isis Intellectual Property or the
Xxxxxx Patents, as the case may be, in the applicable country.
Section 9.2 TERMINATION OF LICENSES AND SUBLICENSES FOR BREACH.
(a) Except as set forth in Section 9.2(b), (i) if an
arbitrator has rendered a ruling pursuant to Article VIII that a Party or
a Subsidiary has materially breached this Agreement or the Master
Agreement, which ruling specified the remedies imposed on such breaching
party for such breach, including without limitation a ruling on a dispute
as to breach of a Party's obligation to issue stock or pay cash in lieu of
stock as required under the Master Agreement (the "ADVERSE RULING"), and
(ii) the breaching Party has failed to comply with the terms of the
Adverse Ruling within the time period specified therein for compliance, or
if such compliance cannot be fully achieved by such date, the breaching
Party has failed to commence compliance and to use diligent efforts to
achieve full compliance as soon thereafter as is reasonably possible, then
the non-breaching Party shall be entitled to terminate the licenses and
sublicenses granted to the breaching Party and its Subsidiaries by such
non-breaching Party under this Agreement (without prejudice to any of the
other rights of the non-breaching Party under this Agreement or the Master
Agreement) upon written notice to the breaching Party.
(b) (i) If a Party breaches an obligation to issue stock or
pay cash in lieu of stock as required under the Master Agreement, then the
non-breaching Party may terminate the licenses and sublicenses granted to
the breaching Party and its Subsidiaries by such
- 30 -
non-breaching Party under this Agreement immediately upon written notice
to the breaching Party if the breaching Party fails to cure such breach
within ten (10) business days of written notice of such breach from the
non-breaching Party; provided, however, that if the breaching Party
believes that a bona fide dispute exists as to the amount of any payment,
then the breaching Party may, not later than five business days following
the notice of the breach, (i) provide the non-breaching Party with a
written notice setting forth the nature of the dispute and the amount in
dispute, (ii) at the same time, pay to the non-breaching Party the amount
of the payment which is not in dispute and (iii) promptly submit the
dispute to binding arbitration pursuant to Article VIII, in which case the
non-payment of the disputed portion shall not be deemed a breach during
the pendency of the arbitration.
- 31 -
(ii) If the final arbitration order or ruling issued
in the arbitration proceeding resolves the dispute against the breaching Party
and orders the breaching Party to pay all or part of the disputed portion to the
non-breaching Party, then the arbitrator shall include in its award, in addition
to such other remedies as it deems appropriate, the following against the
breaching Party: (A) the Arbitration Costs, (B) [*] and (C) if the arbitrator
finds that a cash payment was due, an amount equal to interest at the rate equal
to the lower of 1.5% per month, compounded monthly, or the highest rate
permitted by law on the amount of cash determined to have been due commencing on
the due date determined by the arbitrator through the date of actual payment.
(c) The right of either Party to terminate the licenses and
sublicenses granted by such Party under this Agreement pursuant to this
Section 9.2 shall not be affected in any way by its waiver of, or failure
to take action with respect to any previous default.
(d) If the licenses and sublicenses granted by Hybridon to
Isis and its Subsidiaries under this Agreement are terminated by Hybridon
pursuant to this Section 9.2, (i) Hybridon shall be entitled to retain the
licenses granted to it and its Subsidiaries pursuant to Article III,
subject to the payment obligations of Hybridon specified in the Master
Agreement and in Article IV, and to continue to receive the stock of Isis
issuable to it pursuant to Section 2.3 of the Master Agreement, and (ii)
the provisions of Articles V and VI shall terminate in their entirety. If
the licenses and sublicenses granted by Isis to Hybridon and its
Subsidiaries under this Agreement are terminated by Isis pursuant to this
Section 9.2, Isis shall be entitled to retain the licenses granted to it
and its Subsidiaries pursuant to Article II, subject to the payment
obligations of Isis specified in the Master Agreement and in Article IV,
and to continue to receive the stock of Hybridon issuable to it pursuant
to Section 2.2 of the Master Agreement.
Section 9.3 TERMINATION OF SUBLICENSE OF XXXXXX PATENTS. Hybridon shall
have the right to terminate the sublicense granted to it and its Subsidiaries
pursuant to Section 3.3 (and the related payment obligations under Section 4.2)
for any reason or no reason at any time upon fifteen (15) days prior written
notice to Isis.
Section 9.4 SURVIVAL. The expiration or termination of this Agreement for
any reason shall not relieve the Parties of any obligation due and accruing, or
for any liability as to any breach occurring, prior to such expiration or
termination. In addition, the provisions of Section 4.4, Article VII, Article
VIII, Section 9.4, Section 9.5, and Article X shall survive the expiration or
termination of this Agreement.
*Confidential Treatment Requested - 31 -
Section 9.5 SUBLICENSE SURVIVAL.
(a) Notwithstanding the termination of this Agreement or any
of the licenses or sublicenses granted hereunder pursuant to this Article
IX, any sublicenses to Isis Intellectual Property and the Xxxxxx Patents
granted by Hybridon or its Subsidiaries pursuant to Section 3.2 or 3.3(b)
hereof prior to such termination shall survive such termination. In such
event, Isis shall have the right to receive directly from the Sublicensee
any payments or other consideration otherwise payable to Hybridon or its
Subsidiaries as the sublicensor under such sublicense, and to otherwise
exercise all of the rights of Hybridon or its Subsidiaries as the
sublicensor under such sublicense; provided however that Isis shall not
assume, and shall not be responsible for, any representations, warranties
or obligations of Hybridon or its Subsidiaries as the sublicensor to any
Sublicensees other than the licenses under such sublicenses.
(b) Notwithstanding the termination of this Agreement or any
of the licenses or sublicenses granted hereunder pursuant to this Article
IX, any sublicenses of Hybridon Intellectual Property granted by Isis or
its Subsidiaries pursuant to Section 2.2 hereof prior to such termination
shall survive such termination. In such event, Hybridon shall have the
right to receive directly from the Sublicensee any payments or other
consideration otherwise payable to Isis or its Subsidiaries as the
sublicensor, under such sublicense and to otherwise exercise all of the
rights of Isis or its Subsidiaries as the sublicensor under such
sublicense; provided however that Hybridon shall not assume, and shall not
be responsible for, any representations, warranties or obligations of Isis
or its Subsidiaries as the sublicensor to any Sublicensees other than the
licenses under such sublicenses.
Section 9.6 FAILURE TO MAKE MASTER AGREEMENT DELIVERIES. Notwithstanding
any provision in this Agreement to the contrary, including without limitation
Article VIII, [*] Hybridon shall have the right, at its sole election, effective
immediately upon written notice to Isis, [*]
ARTICLE X
MISCELLANEOUS PROVISIONS
Section 10.1 INDEMNIFICATION. Each Party (the "Indemnifying Party") agrees
to defend the other Party and such other Party's Subsidiaries and their
respective directors, officers, employees and agents (the "Indemnified Parties")
at the Indemnifying Party's cost and expense, and shall indemnify and hold the
Indemnified Parties harmless from and against any losses, costs, damages, fees
or expenses arising out of any third party claim relating to (i) any breach by
the Indemnifying Party of any of its representations, warranties or obligations
*Confidential Treatment Requested - 32 -
pursuant to this Agreement, (ii) provided that the third party is not an
Affiliate of the Indemnified Parties, infringement of such third party's patents
resulting from the exercise by the Indemnifying Party or a Subsidiary or a
Sublicensee of the
*Confidential Treatment Requested - 33 -
rights granted by the Indemnified Parties to the Indemnifying Party hereunder or
(iii) product liability resulting from use of a product made, sold or imported
by or for the Indemnifying Party or by or for a Subsidiary or a Sublicensee
under the rights granted by the Indemnified Parties hereunder. In the event of
any claim against the Indemnified Parties by any third party for which
indemnification may be sought pursuant to this Agreement, the Indemnified
Parties shall promptly notify the Indemnifying Party in writing of the claim;
provided that the failure to promptly notify the Indemnifying Party of such
claim shall not result in the loss of rights of indemnification hereunder except
to the extent that the Indemnifying Party was materially prejudiced by such
failure. The Indemnifying Party shall assume, at its sole expense, the defense
of the claim and its settlement. The Indemnified Parties shall cooperate with
the Indemnifying Party and may, at their option and expense, be represented in
any such action or proceeding. The Indemnifying Party shall not be liable for
any litigation costs or expenses incurred by the Indemnified Parties. In
addition, the Indemnifying Party shall not be responsible for the
indemnification of any Indemnified Party arising from any negligent or wrongful
acts by such Indemnified Party, or as the result of any settlement or compromise
by the Indemnified Parties without the Indemnifying Party's prior written
consent. The Indemnifying Party may not settle or compromise any matter without
the consent of the Indemnified Parties unless such settlement or compromise
imposes no obligations on the Indemnified Parties and does not restrict the
rights of the Indemnified Parties.
Section 10.2 GOVERNING LAW. This Agreement shall be construed and the
respective rights of the Parties determined according to the laws of the State
of
Delaware (without regard to the conflict of law rules of any jurisdiction),
except matters of the intellectual property law, which shall be determined in
accordance with the national intellectual property laws relevant of the
intellectual property in question.
Section 10.3 ASSIGNMENT. Neither Hybridon nor Isis may assign this
Agreement in whole or in part without the consent of the other Party, except if
such assignment occurs in connection with the sale or transfer of all or
substantially all of the business or assets of the assigning Party to which the
subject matters of this Agreement pertains.
Section 10.4 ENTIRE AGREEMENT; AMENDMENTS. This Agreement, together with
the Master Agreement, constitutes the entire agreement between the Parties with
respect to the subject matter hereof, and supersedes all previous arrangements
with respect to the subject matter hereof, whether written or oral. Any
amendment or modification to this Agreement shall be made in writing signed by
both Parties.
Section 10.5 NOTICES.
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Notices to Hybridon shall be addressed to:
Hybridon, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Executive Officer
with a copy to:
Holland and Knight, LLP
00 Xx. Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxx Xxxxxxx, Esq.
And
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxx X. Xxxxxxx, Esq.
- 34 -
Notices to Isis shall be addressed to:
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Executive Officer
Copy to: Executive Vice President
Any Party may change its address by giving notice to the other Party in
the manner herein provided. Any notice required or provided for by the terms of
this Agreement shall be in writing and shall be (a) delivered personally, (b)
sent by registered or certified mail, return receipt requested, postage prepaid,
(c) sent via a reputable overnight courier service, or (d) sent by facsimile
transmission with an original to be followed the same day via a reputable
overnight courier service, in each case properly addressed in accordance with
the paragraph above. The effective date of notice shall be the actual date of
receipt by the Party receiving the same.
Section 10.6 FORCE MAJEURE. No failure or omission by a Party in the
performance of any of its obligations of this Agreement shall be deemed a breach
of this Agreement or create any liability if the same shall arise from any cause
or causes beyond the control of such Party, including, but not limited to, the
following: acts of God; acts or omissions of any government; any rules,
regulations or orders issued by any governmental authority or by any officer,
department, agency or instrumentality thereof; fire; storm; flood; earthquake;
accident; war; rebellion; insurrection; riot; and invasion and provided that
such failure or omission resulting from one of the above causes is cured as soon
as is practicable after the occurrence of one or more of the above-mentioned
causes.
Section 10.7 DISCLOSURE OF PROVISIONS OF AGREEMENT.
(a) Each Party agrees to hold as confidential the terms of
this Agreement, except that (i) Hybridon may furnish a copy of this
Agreement to UMass, Isis may furnish a copy of this Agreement to MBI
(other than Exhibits containing information relating to patent
applications of Hybridon) and each Party shall have the right to disclose
the terms of this Agreement (other than the information on the Exhibits
hereto relating to patent applications of Isis or Hybridon) to potential
investors and other third parties in connection with financing activities
and to potential collaborators, provided that any such third party has
entered into a written obligation with the disclosing Party to treat such
information and materials as confidential and to not use the information
and materials for any purposes other than the evaluation of the potential
- 35 -
investment or collaboration and that the disclosing Party shall enforce
against the third party recipient of such information and materials, for
and on behalf of the other Party, such written obligation, and (ii) each
Party may furnish a copy of this Agreement or disclose the terms of this
Agreement if such is required to be disclosed by the receiving Party to
comply with applicable laws, to defend or prosecute litigation or to
comply with governmental regulations, PROVIDED THAT the receiving Party
provides prior written notice of such disclosure to the disclosing Party
and takes reasonable and lawful actions to avoid and/or minimize the
degree of such disclosure. At the request of the other Party, the
disclosing Party shall use commercially reasonable efforts to enforce such
obligations against such third parties.
(b) Notwithstanding Section 10.7(a) to the contrary, either
Party may include this Agreement, in any report, statement or other
document filed by such Party with the United States Securities and
Exchange Commission (the "SEC"). In such event, the disclosing Party shall
use reasonable efforts to obtain, to the extent permitted by law,
confidential treatment from the SEC of any trade secrets and commercial or
financial information of a privileged or confidential nature, including
without limitation all information on the Exhibits hereto relating to
patent applications of Isis or Hybridon, and shall notify the other Party
as to such efforts and all related communications with the SEC; provided
that notwithstanding the foregoing no Party shall submit a confidentiality
request or include this Agreement without the prior review and approval of
the confidentiality request by the other Party, which review and approval
shall not be unreasonably withheld or delayed.
Section 10.8 INDEPENDENT CONTRACTORS. It is understood and agreed that the
relationship between the Parties hereunder is that of independent contractors
and that nothing in this Agreement shall be construed as authorization for
either Party to act as agent for the other.
Section 10.9 NO STRICT CONSTRUCTION. This Agreement has been prepared
jointly and shall not be strictly construed against any Party.
Section 10.10 HEADINGS. The captions or headings of the Sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
Section 10.11 NO IMPLIED WAIVERS; RIGHTS CUMULATIVE. No failure on the
part of either Party to exercise, and no delay in exercising, any right, power,
remedy or privilege under this Agreement, or provided by statute or at law or in
equity or otherwise, shall impair, prejudice or constitute a waiver of any such
right, power, remedy or privilege or be construed as a waiver of any breach of
this Agreement or as an acquiescence therein, nor shall any single or partial
- 36 -
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege. In particular, the Parties hereby agree that termination of the
licenses or sublicenses granted under this Agreement as provided in Article IX
shall not be the exclusive remedy of a Party in the event of a breach of this
Agreement or the Master Agreement by the other Party and that the non-breaching
Party shall be entitled to seek any and all other remedies to which the
non-breaching Party may be entitled at law or in equity.
Section 10.12 SEVERABILITY. If any provision hereof should be held
invalid, illegal or unenforceable in any respect in any jurisdiction, then, to
the fullest extent permitted by law, (a) all other provisions hereof shall
remain in full force and effect in such jurisdiction and shall be liberally
construed in order to carry out the intentions of the Parties as nearly as may
be possible and (b) such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction.
Section 10.13 EXECUTION IN COUNTERPARTS. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
Section 10.14 NO CONSEQUENTIAL DAMAGES. NEITHER PARTY HERETO WILL BE
LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, REGARDLESS OF ANY NOTICE OF
SUCH DAMAGES.
Section 10.15 PATENT VALIDITY. Notwithstanding anything in this Agreement
to the contrary, neither Party represents and warrants or shall be deemed to
have represented and warranted to the other Party that the Hybridon Intellectual
Property (in the case of Hybridon) and the Isis Intellectual Property and the
Xxxxxx Patents (in the case of Isis) are valid or otherwise enforceable.
[Remainder of page intentionally omitted]
- 37 -
IN WITNESS WHEREOF, the Parties have executed this License Agreement as
of the Effective Date.
ISIS PHARMACEUTICALS, INC.
By: /s/ B. Xxxxx Xxxxxxxx
--------------------------------
Name: B. Xxxxx Xxxxxxxx
------------------------------
Title: Executive Vice President
-----------------------------
HYBRIDON, INC.
By: /s/ Xxxxxx Xxxxxxx
--------------------------------
Name: Xxxxxx Xxxxxxx
------------------------------
Title: President and CSO
-----------------------------
/s/ Xxxxxx Xxxxxxxx, CFO
- 38 -
EXHIBIT A
[ * ]
*Confidential Treatment Requested
EXHIBIT B1
[ * ]
*Confidential Treatment Requested
EXHIBIT B2
[ * ]
*Confidential Treatment Requested
EXHIBIT C
[ * ]
*Confidential Treatment Requested
EXHIBIT D
[ * ]
*Confidential Treatment Requested
EXHIBIT E
[*]
*Confidential Treatment Requested
EXHIBIT F
[ * ]
*Confidential Treatment Requested
EXHIBIT G
[ * ]
*Confidential Treatment Requested
EXHIBIT H-1
THIRD PARTY LICENSE AGREEMENTS
Methylgene
AMENDED AND RESTATED LICENSE AGREEMENT MADE EFFECTIVE AS OF JANUARY 4, 1996, AS
AMENDED AND RESTATED ON SEPTEMBER 21, 2000.
Origenix
LICENSE AGREEMENT DATED AS OF JANUARY 22, 1999 BETWEEN HYBRIDON AND ORIGENIX.
Epigenesis
DEVELOPMENT AND LICENSE AGREEMENT BETWEEN EPIGENESIS PHARMACEUTICALS, INC. AND
HYBRIDON, INC., DATED AS OF AUGUST 9, 2000.
Boston Biosystems, Inc. (BBI)
PNT MONOMER PATENT LICENSE AND OPTION AGREEMENT DATED AS OF SEPTEMBER 20, 2000
BY AND BETWEEN HYBRIDON AND BBI.
OLIGONUCLEOTIDE PURIFICATION PATENT LICENSE AGREEMENT DATED AS OF SEPTEMBER 20,
2000 BY AND BETWEEN HYBRIDON AND BBI.
INTERFERENCE PATENT SUBLICENSE OPTION AGREEMENT DATED AS OF SEPTEMBER 20, 2000
BY AND BETWEEN HYBRIDON AND BBI.
EXHIBIT H-2
OTHER LICENSE AGREEMENTS
UMass Agreement
LICENSE AGREEMENT DATED AS OF FEBRUARY 21, 1990 AND RESTATED AS OF SEPTEMBER 8,
1993 BY AND BETWEEN HYBRIDON AND UNIVERSITY OF MASSACHUSETTS MEDICAL CENTER
(FORMERLY THE WORCESTER FOUNDATION FOR BIOMEDICAL RESEARCH, INC.)
IDT Agreement
Non-Exclusive License Agreement dated as of March 12, 1999 between Integrated
DNA Technologies, Inc. and Hybridon
EXHIBIT I
[ * ]
*Confidential Treatment Requested
EXHIBIT J
UMASS AGREEMENT
Incorporated by reference to Exhibit 10.1 to Hybridon's Registration Statement
on Form S-1 (File No. 33-99024)
*Confidential Treatment Requested
EXHIBIT K
[ * ]
*Confidential Treatment Requested
EXHIBIT L
[ * ]
*Confidential Treatment Requested
EXHIBIT M
[ * ]
*Confidential Treatment Requested
EXHIBIT N
XXXXXX AGREEMENT
Incorporated by reference to Exhibit 10.1 to Isis's Quarterly Report Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly
period ended September 30, 1992, on Form 10-Q (File No. 0-19125).
