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EXHIBIT 10.40
RESEARCH LICENSE AND OPTION AGREEMENT
THIS RESEARCH LICENSE AND OPTION AGREEMENT (this "Agreement"), effective
as of January 4, 1999 (the "Effective Date"), is made by and between ABGENIX,
INC., a Delaware corporation ("ABX"), having a place of business at 0000
Xxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000, and AVI BIOPHARMA, INC., an Oregon
corporation ("AVI"), having a place of business at Xxx XX Xxxxxxxx Xxxxxx, Xxxxx
0000, Xxxxxxxx, Xxxxxx 00000, with respect to the following facts:
RECITALS
WHEREAS, ABX has rights in certain XenoMouse(TM) Animals (as defined
below) that are capable of producing human antibodies when immunized with an
antigen.
WHEREAS, AVI desires to generate human antibodies to the Antigen (as
defined below).
WHEREAS, AVI has immunized XenoMouse Animals with the Antigen pursuant
to the Research Collaboration Agreement (as defined below).
WHEREAS, ABX is willing to grant to AVI, and AVI desires to obtain, a
license to use XenoMouse Animals solely for immunization with the Antigen for
research purposes, as described below and on the terms and conditions set forth
herein.
WHEREAS, ABX additionally is willing to offer to AVI the opportunity to
obtain an exclusive option to enter into the AVI Product License Agreement (as
defined below) on the terms and conditions set forth herein.
NOW THEREFORE, in consideration of the foregoing premises and the mutual
covenants set forth below, the parties agree as follows:
1. DEFINITIONS
For purposes of this Agreement, the terms set forth in this Article 1
shall have the respective meanings set forth below:
1.1 "ABX In-License" shall mean a license, sublicense or other agreement
under which ABX acquired rights to the ABX Patent Rights or ABX Know-How.
1.2 "ABX Inventions" shall mean, collectively, all inventions,
discoveries, data, information, methods, techniques, technology and other
results, whether or not patentable (other than Materials), that are made,
conceived, reduced to practice or otherwise derived from the parties' use of the
ABX Materials; provided, however, that the ABX Inventions shall exclude the
Research Program Inventions.
1.3 "ABX Know-How" shall mean, collectively, all inventions,
discoveries, data,
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information, methods, techniques, technology and other results, whether or not
patentable but which are not generally known, regarding (a) methods and
techniques of immunizing the XenoMouse Animals to the Antigen, which are
disclosed by ABX to AVI pursuant to the Research Collaboration Agreement, this
Agreement or the AVI Product License Agreement (if entered into by the parties),
or (b) ABX Materials and ABX Inventions. All ABX Know-How shall be Confidential
Information of ABX.
1.4 "ABX Materials" shall mean, collectively, (a) all XenoMouse Animals,
including all XenoMouse Animals immunized with the Antigen, and all other
materials specified in Exhibit A to the Research Collaboration Agreement; [*];
provided, however, that the ABX Materials shall exclude the Research Program
Materials. All ABX Materials shall be Confidential Information of ABX.
1.5 "ABX Patent Rights" shall mean, collectively, (a) all patents and
patent applications listed on Exhibit B and any foreign counterparts claiming
priority thereof; (b) all patent applications heretofore or hereafter filed in
any country which claim ABX Materials delivered to AVI or ABX Inventions; (c)
all patents that have issued or in the future issue from any of the foregoing
patent applications, including without limitation utility, model and design
patents and certificates of invention; and (d) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications.
1.6 "Affiliate" shall mean, with respect to any person or entity, any
other person or entity which controls, is controlled by or is under common
control with such person or entity. A person or entity shall be regarded as in
control of another entity if it owns or controls at least fifty percent (50%) of
the equity securities of the subject entity entitled to vote in the election of
directors (or, in the case of an entity that is not a corporation, for the
election of the corresponding managing authority).
1.7 "Antibody" shall mean a composition comprising (a) a whole antibody,
or any fragment thereof, derived from the XenoMouse Animals, or (b) a whole
antibody, or any fragment thereof, which is derived from a whole antibody, or
any fragment thereof, which itself is derived from the XenoMouse Animals (or
from the nucleotide sequences that encode, or amino acid sequences of, a whole
antibody, or any fragment thereof, derived from the XenoMouse Animals).
1.8 "Antibody Cells" shall mean all cells that contain, express, or
secrete antibodies, genetic materials that encode antibodies.
1.9 "Antigen" shall mean (beta) human chorionic gonadotropin
((beta)HCG).
1.10 "AVI Inventions" shall mean, collectively, all inventions,
discoveries, data,
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information, methods, techniques, technology and other results, whether or not
patentable (other than Materials), solely regarding the Antigen, or the use
thereof, that are made, conceived, reduced to practice or otherwise derived from
the research or development work conducted pursuant to and in accordance with
the Research Collaboration Agreement, this Agreement or the AVI Product License
Agreement (if entered into by the parties); provided, however, that the AVI
Inventions shall exclude the ABX Inventions and the Research Program Inventions.
1.11 "AVI Know-How" shall mean, collectively, all inventions,
discoveries, data, information, methods, techniques, technology and other
results, whether or not patentable but which are not generally known, regarding
(a) the Antigen which are disclosed by AVI to ABX pursuant to the Research
Collaboration Agreement, this Agreement or the AVI Product License Agreement (if
entered into by the parties), and (b) AVI Materials and AVI Inventions. All AVI
Know-How shall be Confidential Information of AVI.
1.12 "AVI Materials" shall mean, collectively, (a) the Antigen, and (b)
all reagents, samples and other chemical or biological materials solely
regarding the Antigen resulting from the parties' use of the Antigen; provided,
however, that the AVI Materials shall exclude the Research Program Materials.
All AVI Materials shall be Confidential Information of AVI.
1.13 "AVI Patent Rights" shall mean, collectively, (a) all patent
applications heretofore or hereafter filed in any country which claim AVI
Materials or AVI Inventions; (b) all patents that have issued or in the future
issue from any of the foregoing patent applications, including without
limitation utility, model and design patents and certificates of invention; and
(c) all divisionals, continuations, continuations-in-part, reissues, renewals,
extensions or additions to any such patents and patent applications.
1.14 "AVI Product License Agreement" shall mean a license agreement
between ABX and AVI in the form attached hereto as Exhibit C (subject to the
provisions of Section 3.2.3).
1.15 "Confidential Information" shall mean, with respect to a party, all
information of any kind whatsoever (including without limitation, compilations,
data, formulae, models, patent disclosures, procedures, processes, projections,
protocols, results of experimentation and testing, specifications, strategies
and techniques), and all tangible and intangible embodiments thereof of any kind
whatsoever (including without limitation, apparatus, biological or chemical
materials, animals, cells, compositions, documents, drawings, machinery, patent
applications, records, reports), which is owned or controlled by such party, is
disclosed by such party to the other party pursuant to the Research
Collaboration Agreement or this Agreement, and (if disclosed in writing or other
tangible medium) is marked or identified as confidential at the time of
disclosure to the receiving party or (if otherwise disclosed) is identified as
confidential at the time of disclosure to the receiving party and described as
such in writing within thirty (30) days after such disclosure. Notwithstanding
the foregoing, Confidential Information of a party shall not include information
which the receiving party can establish by written documentation (a) to have
been publicly known prior to disclosure of such information by the disclosing
party to the receiving party, (b) to have become publicly known, without fault
on the part of the receiving party, subsequent to disclosure of such information
by the disclosing party to the receiving party, (c) to have been received by the
receiving party at any time from a source, other than the disclosing party,
rightfully having possession of and the right to disclose such information free
of confidentiality obligations, (d) to have been otherwise known by the
receiving party free of confidentiality obligations prior to
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disclosure of such information by the disclosing party to the receiving party,
or (e) to have been independently developed by employees or agents of the
receiving party without access to or use of such information disclosed by the
disclosing party to the receiving party. The parties acknowledge that the
foregoing exceptions shall be narrowly construed and that the obligations
imposed upon each party under Section 5 below shall be relieved solely with
respect to such Confidential Information of the disclosing party which falls
within the above exceptions and not with respect to related portions, other
combinations, or characteristics of the Confidential Information of the
disclosing party including, without limitation, advantages, operability,
specific purposes, uses and the like.
1.16 "Derived" or "derived" shall mean obtained, developed, created,
synthesized, designed, derived or resulting from, based upon or otherwise
generated (whether directly or indirectly, or in whole or in part).
1.17 "Excluded Technology" shall mean, collectively, (a) all patent
rights, know-how or other intellectual property rights or technology of ABX in
or to (i) all antigens other than the Antigen, including without limitation (A)
compositions of such antigens or of Genetic Materials that encode such antigens;
(B) uses of such antigens; (C) antibodies or other compositions that bind to
such antigens, Genetic Materials that encode such antibodies or compositions,
and Antibody Cells that express, secrete, or contain such antibodies, Genetic
Materials or compositions; and (D) uses of such antibodies, Genetic Materials or
compositions; (ii) methods to discover novel antigens; and (iii) methods of
using antigens other than to create antibodies; (b)(i) all patent applications
heretofore or hereafter filed in any country which claim ABX Materials (except
for those described in clause (a) of Section 1.4 above) or ABX Inventions; (ii)
all patents that have issued or in the future issue from any of the foregoing
patent applications, including without limitation utility, model and design
patents and certificates of invention; and (iii) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications; and (c) inventions, discoveries, data,
information, methods, techniques, technology and other results, whether or not
patentable but which are not generally known, regarding ABX Materials (except
for those described in clause (a) of Section 1.4 above) and ABX Inventions.
1.18 "Field" shall mean the use of Products for human medical purposes.
1.19 "Genetic Material" shall mean a nucleotide sequence, including DNA,
RNA and complementary and reverse complementary nucleotide sequences thereto,
whether coding or noncoding and whether intact or a fragment.
1.20 "GenPharm Cross License Agreement" shall mean that certain Cross
License Agreement entered into by and between ABX, JTI, XT, Cell Genesys, Inc.,
and GenPharm International, Inc., effective as of March 26, 1997, as the same
may be amended from time to time.
1.21 "IND" shall mean an Investigational New Drug application filed with
Food and Drug Administration in the United States, or any similar filing with
any foreign regulatory authority, to commence human clinical testing of any
Product in any country in the Territory.
1.22 "Inventions" shall mean, collectively, the ABX Inventions, the AVI
Inventions and the Research Program Inventions.
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1.23 "JTI" shall mean Japan Tobacco Inc., a Japanese corporation.
1.24 "Licensed Technology" shall mean ABX's rights in the ABX Patent
Rights, ABX Know-How, Research Program Patent Rights and Research Program
Know-How; provided, however, that the Licensed Technology (a) is all to the
extent and only to the extent that ABX has the right to grant (sub)licenses
thereunder (including without limitation to the extent permitted under the
applicable ABX In-Licenses); (b) is expressly subject to the ABX In-Licenses;
and (c) shall exclude the Excluded Technology.
1.25 "Materials" shall mean, collectively, the ABX Materials, the AVI
Materials and the Research Program Materials.
1.26 "Option" shall have the meaning set forth in Section 3.1.1 below.
1.27 "Product" shall mean any product comprising (a) an Antibody which
binds to the Antigen, or (b) Genetic Material that encodes such an Antibody
wherein, in respect of each Product, said Genetic Material does not encode
multiple antibodies.
1.28 "Research Collaboration Agreement" shall mean the Research
Collaboration Agreement effective as of October 2, 1998, between ABX and AVI.
1.29 "Research Field" shall mean the immunization of XenoMouse Animals
with the Antigen and the use of XenoMouse Animals that are so immunized and
materials derived from XenoMouse Animals that are so immunized, in each case
solely for the creation, identification, analysis, research, characterization
and preclinical development of Products for use in the Field.
1.30 "Research Program Inventions" shall mean, collectively, all
inventions, discoveries, data, information, methods, techniques, technology and
other results, whether or not patentable (other than Materials), regarding the
Research Program Materials, or the use thereof, that are made, conceived,
reduced to practice or otherwise derived from the research or development work
conducted pursuant to and in accordance with the Research Collaboration
Agreement, this Agreement or the AVI Product License Agreement (if entered into
by the parties).
1.31 "Research Program Know-How" shall mean, collectively, all
inventions, discoveries, data, information, methods, techniques, technology and
other results, whether or not patentable but which are not generally known,
regarding Research Program Materials and Research Program Inventions. All
Research Program Know-How shall be Confidential Information of ABX.
1.32 "Research Program Materials" shall mean, collectively, [*]; in each
case that are made, conceived, reduced to practice or otherwise derived from the
research or development work conducted pursuant to and in accordance with the
Research Collaboration Agreement, this Agreement or the AVI Product License
Agreement (if entered into by the parties). All Research Program Materials shall
be Confidential Information of [*].
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1.33 "Research Program Patent Rights" shall mean, collectively, (a) all
patent applications heretofore or hereafter filed in any country which claim
Research Program Materials or Research Program Inventions; (b) all patents that
have issued or in the future issue from any of the foregoing patent
applications, including without limitation utility, model and design patents and
certificates of invention; and (c) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications.
1.34 "XenoMouse Animals" shall mean one or more sterile male transgenic
mice provided by ABX to AVI for immunization with the Antigen under either the
Research Collaboration Agreement or this Agreement.
1.35 "XT" shall mean Xenotech, L.P., a California limited partnership.
1.36 "XT Master Research and License Agreement" shall mean that certain
Master Research License and Option Agreement entered into by and among XT, JTI
and Cell Genesys, Inc. effective as of June 28, 1996, and subsequently assigned
to ABX by Cell Genesys, Inc., as the same may be amended from time to time.
1.37 "XT Product License" shall mean a license granted from XT to ABX
pursuant to the terms of the XT Master Research and License Agreement permitting
ABX to commercialize, or to provide rights to a third party to commercialize,
certain Products in one or more territories.
2. ABX MATERIALS AND RESEARCH LICENSE
2.1 Supply of ABX Materials.
2.1.1 Supply. Subject to the terms and conditions of this
Agreement, including those set forth in Section 2.2 below, on or before the
Effective Date, ABX shall have provided to AVI, solely for use in creating
Antibodies to the Antigen for use in the Research Field, the sterilized male
XenoMouse Animals and other ABX Materials described in Exhibit A to the Research
Collaboration Agreement.
2.1.2 Research. Except as the parties otherwise expressly agree
in writing, AVI shall be responsible for conducting all activities under this
Agreement in the Research Field, including without limitation immunization of
XenoMouse Animals with the Antigen, screening of Antibodies generated from such
immunizations, and creation of Antibody Cells that contain, express, or secrete
Antibodies to the Antigen.
2.1.3 Ownership of Materials. [*] shall solely own all right
title and interest in and to the ABX Materials and Research Program Materials
and all intellectual property rights therein and thereto. [*] shall solely own
all right title and interest in and to the AVI Materials and all intellectual
property rights therein and thereto. The transfer of physical possession of any
Materials owned by, and the physical possession and use of any Materials by, AVI
or ABX, as the case may be, shall not be (nor be construed as) a sale, lease,
offer to sell or lease, or other transfer of title of such Materials to AVI or
ABX, as the case may be.
2.1.4 Use of ABX Materials. Except as otherwise expressly
provided in the AVI Product License Agreement (if entered into by the parties),
all XenoMouse Animals and other ABX
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Materials are for use by AVI solely to perform research in the Research Field as
permitted pursuant to Section 2.3(a). AVI shall limit access to the ABX
Materials to those of its employees working on its premises, to the extent such
access is reasonably necessary in connection with its activities as expressly
authorized by this Agreement.
2.2 Material Transfer Terms. Except as otherwise expressly permitted by
the license grant in Section 2.1.1 of the AVI Product License Agreement (if
entered into by the parties), AVI's right to use the XenoMouse Animals and other
ABX Materials are subject to the following terms and conditions:
(a) All XenoMouse Animals transferred to AVI shall be the sole
property of ABX, and the transfer of physical possession to AVI, and/or
possession or use by AVI, of XenoMouse Animals shall not be, nor be construed
as, a sale, lease, offer to sell or lease, or other transfer of title to or any
interest in any XenoMouse Animals;
(b) All XenoMouse Animals and all materials derived from the
XenoMouse Animals (including without limitation Products) shall remain in the
control of AVI, and AVI shall not (and shall not attempt or purport to) transfer
the XenoMouse Animals or any materials derived from the XenoMouse Animals
(including without limitation Products) to any third party (other than ABX),
without the prior express written consent of ABX (which may be conditioned inter
alia upon such other third party duly executing and delivering ABX's standard
form of material transfer agreement therefor);
(c) AVI shall not directly or indirectly use or attempt to use
the XenoMouse Animals, or any information or biological or chemical materials
derived from the XenoMouse Animals (including without limitation Products), to
reproduce, generate, create or produce, through breeding, reverse-engineering,
genetic manipulation or otherwise, the XenoMouse Animals or other transgenic
mice or other transgenic animals;
(d) The XenoMouse Animals shall be delivered to AVI solely for
the purpose of immunizing the XenoMouse Animals with the Antigen, and AVI shall
not use the XenoMouse Animals, or any materials derived from the XenoMouse
Animals (including without limitation Products), for screening or any purpose
other than immunizing the XenoMouse Animals with the Antigen pursuant to the
Research Collaboration Agreement and conducting research in the Research Field
as permitted pursuant to Section 2.4(a);
(e) AVI shall not (and shall not attempt or purport to) assign,
sell, have sold, lease, offer to sell or lease, distribute, license, sublicense
or otherwise transfer title to or an interest in, or clinically develop,
commercialize or otherwise exploit any XenoMouse Animals or any materials
derived from the XenoMouse Animals (including without limitation Products);
(f) AVI shall not use the XenoMouse Animals to make or use
antibodies to any antigen other than the Antigen (including without limitation
to [*]);
(g) Upon expiration or termination of this Agreement for any
reason, AVI shall destroy and certify such destruction (or return to ABX as
directed by ABX) each XenoMouse Animal, all ABX Materials and all Research
Program Materials within ten (10) days after such expiration or termination;
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(h) Upon expiration or termination of this Agreement for any
reason, AVI shall not (and shall not attempt or purport to) assign, sell, have
sold, lease, offer to sell or lease, distribute, license, sublicense or
otherwise transfer title to or an interest in, or clinically develop,
commercialize or otherwise exploit the Research Program Materials, Research
Program Inventions, Research Program Patent Rights or Research Program Know-How
for any purpose whatsoever, and shall not (and shall not attempt or purport to)
grant to any third party any right or license to do any of the foregoing;
(i) Notwithstanding anything to the contrary in this Agreement,
ABX shall own all right, title and interest in and to all materials, inventions,
discoveries, data, information, methods, techniques, technology and other
results (whether patentable or nonpatentable), and all intellectual property
rights therein and thereto, made or created by AVI (and any of its agents or
employees) through any use of the XenoMouse Animals and/or materials derived
from the XenoMouse Animals (including without limitation Products), which use is
not in accordance with the terms and conditions set forth in this Article 2;
(j) AVI shall only use the XenoMouse Animals and all materials
derived from the XenoMouse Animals (including without limitation Products) in
compliance with all applicable national, state, and local laws and regulations,
including all applicable National Institutes of Health guidelines. AVI
acknowledges that the XenoMouse Animals, and all materials derived from the
XenoMouse Animals (including without limitation Products), are experimental in
nature and may have unknown characteristics. AVI shall use prudence and
reasonable care in the use, handling, storage, transportation, disposition and
containment of the XenoMouse Animals and all materials derived from the
XenoMouse Animals (including without limitation Products), and shall not use any
such materials in humans;
(k) Unless otherwise agreed by ABX in advance in writing, all
XenoMouse Animals delivered to AVI shall be delivered to AVI's facilities
located at its address set forth above, and such XenoMouse Animals shall not
leave such facility (except for return of XenoMouse Animals to ABX or upon
destruction of the XenoMouse Animals by AVI); and
(l) XT shall be a third-party beneficiary of the commitments by
AVI set forth in items (a) through (f) above.
2.3 Research License.
(a) Subject to the terms and conditions of this Agreement, ABX
hereby grants to AVI a nonexclusive license (or sublicense, as the case may be)
under the Licensed Technology, without right to grant sublicenses, (i) to use
the XenoMouse Animals provided by ABX solely for use in the Research Field, (ii)
to make and use (but not to transfer, sell, lease, offer to sell or lease, or
otherwise transfer title to or an interest in) Antibody Cells that contain,
express, or secrete Antibodies to the Antigen solely for use in the Research
Field, and (iii) to make and use (but not to transfer, sell, lease, offer to
sell or lease, or otherwise transfer title to or an interest in) Products solely
for research and development of such Products in the Research Field. AVI shall
not use the Licensed Technology or any materials derived from the XenoMouse
Animals (including without limitation Products) for any other purpose other than
those uses expressly licensed under this Section 2.3(a).
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(b) The license granted under Section 2.3(a) shall terminate upon
the earlier of (i) the date on which ABX duly executes and delivers the AVI
Product License Agreement in accordance with the provisions of Section 3.2.3,
and (ii) the date of the expiration or earlier termination of this Agreement.
(c) No implied licenses or rights are conveyed to AVI hereunder.
AVI shall only be authorized regarding the research use of XenoMouse Animals and
the research use of materials derived from the XenoMouse Animals (including
without limitation Products) solely as expressly provided in this Article 2.
2.4 Limitation. Notwithstanding any other provision of this Agreement,
in no event shall AVI (a) file, or authorize any third party to file, an IND
with respect to a Product or (b) initiate, or authorize any third party to
initiate, clinical trials in humans with respect to a Product or otherwise
utilize or introduce in any way a Product into humans (or sell, or authorize any
third party to sell, a Product).
2.5 Exclusivity. During the term of this Agreement, AVI shall not
develop or sell any other human, humanized or chimeric antibody or fragment
thereof that binds to the Antigen, or enter into any agreement with any third
party for the creation, research, characterization, development or
commercialization of such antibodies or fragments thereof, without prior express
written consent of ABX.
2.6 Reports. AVI shall keep (or cause to be kept) complete and accurate
records of its research activities under this Agreement. AVI shall maintain (or
cause to be maintained) such records in sufficient detail, and in accordance
with good scientific practices. AVI shall keep ABX fully informed as to its
research activities hereunder. Without limiting the foregoing, within thirty
(30) days of the end of each calendar quarter, AVI shall provide to ABX a
reasonably detailed written report regarding such research activities and the
status thereof (including a description of all potentially patentable Research
Program Inventions).
3. OPTION TO OBTAIN AVI PRODUCT LICENSE AGREEMENT
3.1 Option. Subject to the terms and conditions set forth in this
Agreement, ABX hereby grants to AVI the exclusive option (the "Option"),
exercisable for a period (the "Option Period") of one (1) year from the date of
the Research Collaboration Agreement, to enter into the AVI Product License
Agreement pursuant to the procedures set forth in this Article 3.
3.2 Exercise of Option.
3.2.1 Exercise. The Option may be exercised, at any time during
the Option Period, by AVI (a) giving ABX express written notice (the "Exercise
Notice") stating that AVI desires that ABX obtain the XT Product License for the
Antigen and that the parties enter into the AVI Product License Agreement, and
(b) paying to ABX the [*] option exercise fee (the "Exercise Fee") [*]. If ABX
has not received the Exercise Notice and the Exercise Fee on or before the
expiration of the Option Period, this Agreement immediately shall terminate. The
Exercise Fee shall be paid in U.S. dollars, and shall be made by bank wire
transfer in immediately available
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funds to an account designed by ABX.
3.2.2 XT Product License. Following AVI's exercise of the Option,
ABX shall exercise its option under the XT Master Research and License Agreement
to obtain the XT Product License for the Antigen. ABX shall notify AVI at such
time as ABX has obtained the XT Product License for the Antigen.
3.2.3 AVI Product License Agreement. Within ten (10) days after
AVI's receipt of notice that ABX has obtained the XT Product License for the
Antigen, AVI shall duly execute and deliver the AVI Product License Agreement
and shall pay to ABX the license fee set forth in Section 3.1 of the AVI Product
License Agreement. Upon ABX's timely receipt of such duly executed and delivered
AVI Product License Agreement and license fee, ABX shall duly execute and
deliver the AVI Product License Agreement. If AVI fails to timely duly execute
and deliver the AVI Product License Agreement, and to pay to ABX the license fee
set forth in Section 3.1 of the AVI Product License Agreement, as set forth
above, then (a) ABX shall have no further obligation to AVI regarding the AVI
Product License Agreement, and (b) ABX shall be entitled, in its sole
discretion, to exercise ABX's rights under the XT Master Research and License
Agreement and enter into the XT Product License for the Antigen on its own
behalf or on behalf of a third party without further obligation to AVI.
3.3 Definition of Antigen. ABX shall use good faith efforts to cause the
definition of the Antigen under the XT Product License (as established in
accordance with the XT Master Research and License Agreement) to be the same as
the definition of the Antigen under this Agreement; provided, however, that the
precise definition of the Antigen defining the rights licensed to ABX under the
XT Product License (and the definition in the corresponding AVI Product License
Agreement) shall be as established in accordance with the XT Master Research and
License Agreement.
4. INVENTIONS AND INTELLECTUAL PROPERTY RIGHTS
4.1 Ownership. [*] shall solely own all right title and interest in and
to the ABX Inventions and Research Program Inventions and all intellectual
property rights therein and thereto. [*] shall solely own all right title and
interest in and to the AVI Inventions and all intellectual property rights
therein and thereto. The transfer of physical possession of any Inventions owned
by, and the physical possession and use of any Inventions by, AVI or ABX, as the
case may be, shall not be (nor be construed as) a sale, lease, offer to sell or
lease, or other transfer of title of such Inventions to AVI or ABX, as the case
may be.
4.2 Assignment and Disclosure of Inventions. AVI and ABX shall cause
each employee, agent, or independent contractor that conducts research pursuant
to the Research Collaboration Agreement or this Agreement promptly disclose to
the other party, and appropriately assign in accordance with this Agreement any
and all right, title and interest in and to any Inventions and all intellectual
property rights therein and thereto. AVI and ABX shall maintain records in
sufficient detail and in good scientific manner appropriate for patent purposes
and so as to properly reflect all work done and results achieved in performing
its rights and obligations hereunder, and agrees to respond to reasonable
requests from AVI or ABX, as the case may be, for information based upon such
records.
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4.3 Prosecution and Maintenance of Patent Rights.
4.3.1 AVI Patent Rights. AVI shall have the sole right and
responsibility (but not the obligation), at its expense, to prepare, file,
prosecute and maintain all patent applications and patents (and to conduct any
interferences, oppositions, or reexaminations thereon, and to request any
reissues or patent term extensions thereof) within the AVI Patent Rights.
4.3.2 Research Program Patent Rights. Except as otherwise set
forth in the Antigen Product License (if entered into by the parties), AVI shall
have the first right and responsibility (but not the obligation), at its
expense, to prepare, file, prosecute and maintain all patent applications and
patents (and to conduct any interferences, oppositions, or reexaminations
thereon, and to request any reissues or patent term extensions thereof) within
the Research Program Patent Rights. AVI shall: (i) provide ABX with a copy of
any patent application proposed to be filed hereunder by AVI promptly prior to
filing and receive and incorporate reasonable comments by ABX thereon; (ii)
provide ABX with any patent application filed hereunder by AVI promptly after
such filing; (iii) provide ABX promptly with copies of all substantive
communications received from or filed in patent office(s) with respect to such
filings and receive and incorporate reasonable comments by ABX thereon; (iv)
notify ABX of any interference, opposition, reexamination request, nullity
proceeding, appeal or other interparty action and review it with the ABX as
reasonably requested; and (v) a reasonable time prior to taking or failing to
take any action that would substantially affect the scope of validity of rights
under such patent applications or patents (including substantially narrowing or
canceling any claim without reserving the right to file a continuing or
divisional application, abandoning any patent or not filing or perfecting the
filing of any patent application), provide ABX with notice of such proposed
action so that ABX has a reasonable opportunity to review and make comments. ABX
shall assist AVI upon request and at AVI's sole expense, and to the extent
commercially reasonable, in preparing, filing or maintaining the patent
applications and patents claiming Research Program. If AVI fails to undertake
the preparation and filing of a patent application (or continuing or divisional
application) within ninety (90) days after a written request from ABX to do so,
or if AVI discontinues the prosecution or maintenance of a patent application or
a patent, ABX at its expense may, in its discretion, undertake such preparation,
filing, prosecution or maintenance thereof, in which case such patent
application and patent thereon shall be excluded from the Licensed Technology.
4.4 Enforcement of Patent Rights.
4.4.1 ABX Patent Rights. ABX shall have the sole right and
responsibility (but not the obligation), at its expense, to enforce the ABX
Patent Rights.
4.4.2 AVI Patent Rights. AVI shall have the sole right and
responsibility (but not the obligation), at its expense, to enforce the AVI
Patent Rights.
4.4.3 Research Program Patent Rights.
(a) ABX shall have the sole right and responsibility (but not the
obligation), at its expense, to enforce the Research Program Patent Rights. AVI
shall assist ABX, upon request and at ABX's sole expense, and to the extent
commercially reasonable, in enforcing the Research Program Patent Rights.
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(b) If ABX fails to xxxxx an infringement of the Research Program
Patent Rights, or to file an action to xxxxx such infringement, within ninety
(90) days after a written request from AVI to do so, or if ABX discontinues the
prosecution of any such action after filing without abating such infringement,
AVI at its expense may, in its discretion, undertake such action as it
determines appropriate to enforce such Research Program Patent Rights against
such infringer. In such case, ABX shall reasonably assist AVI, upon request and
at AVI's sole expense, and to the extent commercially reasonable, in taking any
action to enforce such Research Program Patent Rights against such infringer.
(c) All monies recovered upon the final judgment or settlement of
any such action shall be used (i) first, to reimburse the costs and expenses
(including reasonable attorneys' fees and costs) of AVI and ABX, (ii) second (to
the extent that damages are awarded for lost sales or lost profits from the sale
of Products), to ABX taking into account the royalties that would have been
payable to ABX on the sale of such Products, and (iii) the remainder to the
account of the party or parties that undertake such actions to the extent of
their financial participation therein.
4.5 Grant-Back. It is the intent of the parties that this Agreement
shall not restrict ABX's freedom to operate regarding the practice and
commercialization of the Licensed Technology (including without limitation
XenoMouse Animals and cells, genetic material, and antibodies derived from
XenoMouse Animals), except as expressly set forth herein regarding the Antigen.
Accordingly, in the event that any patent owned or controlled by AVI that
directly arises from use of the XenoMouse Animals that has application other
than for the manufacture, use, sale, offer for sale or import of Products, AVI
hereby grants to ABX a royalty-free, perpetual, irrevocable license in the
Territory, with the right to grant and authorize sublicenses, under all such
patents for all fields of use other than the manufacture, use, sale, offer for
sale or import of Products.
5. CONFIDENTIALITY
5.1 Confidentiality. Except as expressly provided herein, AVI and ABX
each shall keep completely confidential and shall not publish or otherwise
disclose and shall not use for any purpose any Confidential Information of the
other until the date five (5) years following the expiration or termination of
this Agreement.
5.2 Permitted Disclosure. Notwithstanding Section 5.1 above, each party
may nevertheless disclose the other party's Confidential Information to the
extent such disclosure is required by applicable law, regulation or court order,
provided that if a party is so required to make any such disclosure of the other
party's Confidential Information, other than pursuant to a confidentiality
agreement, it will give reasonable advance notice to the other party of such
disclosure requirement and will use efforts consistent with prudent business
judgment to secure confidential treatment of such information prior to its
disclosure (whether through protective orders or confidentiality agreements or
otherwise). The expiration of AVI's obligations under Section 5.1 above shall
not limit AVI's obligations under Section 2.2 above.
5.3 Terms of Agreement. Neither party shall disclose any terms or
conditions of this Agreement to any third party without the prior consent of the
other party; provided, however, that a party may disclose the terms or
conditions of this Agreement, (i) on a need-to-know basis to its
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legal and financial advisors to the extent such disclosure is reasonably
necessary in connection with such party's activities as expressly permitted by
this Agreement, (ii) to a third party in connection with (A) an equity
investment in such party by a third party, (B) a merger, consolidation or
similar transaction entered into by such party, or (C) the sale of all or
substantially all of the assets of such party, and (iii) as may, in the
reasonable opinion of such party's counsel, be required by applicable law,
regulation or court order, including without limitation, a disclosure in
connection with such party's filing of a registration statement or other filing
with the United States Securities and Exchange Commission (in which event such
party will first consult with the other party with respect to such disclosure).
Notwithstanding the foregoing, prior to execution of this Agreement, ABX and AVI
shall agree upon the substance of information that can be used to describe the
terms of this transaction, and each party may disclose such information, as
modified by written agreement of ABX and AVI from time to time, without the
consent of the other.
6. INDEMNIFICATION
6.1 AVI. AVI shall indemnify and hold harmless ABX, and its directors,
officers, employees and agents, from and against all losses, liabilities,
damages and expenses, including reasonable attorneys' fees and costs
(collectively, "Liabilities"), resulting from any claims, demands, actions or
other proceedings by any third party arising from (i) the material breach of any
representation, warranty or covenant by AVI under this Agreement, (ii) the use
by AVI of the Licensed Technology, (iii) any use, handling or storage by AVI of
Materials or Products, or (iv) any use by AVI of the Confidential Information of
ABX; provided, however, that AVI shall not be obligated to indemnify or hold
harmless ABX for such Liabilities to the extent that such Liabilities arise from
the gross negligence or willful misconduct of ABX.
6.2 ABX. ABX shall indemnify and hold harmless AVI, and its directors,
officers, employees and agents, from and against all Liabilities resulting from
any claims, demands, actions or other proceedings by any third party arising
from (i) the material breach of any representation, warranty or covenant by ABX
under this Agreement , or (ii) any use by ABX of the Confidential Information of
AVI; provided, however, that ABX shall not be obligated to indemnify or hold
harmless AVI for such Liabilities to the extent that such Liabilities arise from
the gross negligence or willful misconduct of AVI.
6.3 Procedure. If a party (an "Indemnitee") intends to claim
indemnification under this Article 6, it shall promptly notify the indemnifying
party (the "Indemnitor") in writing of any claim, demand, action or other
proceeding for which the Indemnitee intends to claim such indemnification, and
the Indemnitor shall have the right to participate in, and, to the extent the
Indemnitor so desires, to assume the defense thereof with counsel mutually
satisfactory to the parties; provided, however, that an Indemnitee shall have
the right to retain its own counsel, with the fees and expenses to be paid by
the Indemnitor, if representation of such Indemnitee by the counsel retained by
the Indemnitor would be inappropriate due to actual or potential differing
interests between such Indemnitee and any other party represented by such
counsel in such proceeding. The indemnity agreement in this Article 6 shall not
apply to amounts paid in settlement of any claim, demand, action or other
proceeding if such settlement is effected without the consent of the Indemnitor,
which consent shall not be withheld or delayed unreasonably. The failure to
deliver written notice to
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the Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall relieve such
Indemnitor of any liability to the Indemnitee under this Article 6, but the
omission so to deliver written notice to the Indemnitor shall not relieve it of
any liability that it may have to any party claiming indemnification otherwise
than under this Article 6. The party claiming indemnification under this Article
6, its employees and agents, shall reasonably cooperate with the Indemnitor and
its legal representatives in the investigation of any claim, demand, action or
other proceeding covered by this indemnification.
7. REPRESENTATIONS AND WARRANTIES
7.1 ABX. ABX represents and warrants that: (i) it has the power and
authority to enter into this Agreement; (ii) to the knowledge of ABX, there are
no existing or threatened actions, suits or claims pending with respect to the
subject matter hereof or the right of ABX to enter into and perform its
obligations under this Agreement; (iii) it has taken all necessary action on its
part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder; (iv) this Agreement has been duly
executed and delivered on behalf of it, and constitutes a legal, valid, binding
obligation, enforceable against it in accordance with the terms hereof; and (v)
the execution and delivery of this Agreement and the performance of its
obligations hereunder do not conflict with or violate any requirement of
applicable laws or regulations and do not conflict with, or constitute a default
under, any contractual obligation of it.
7.2 AVI. AVI represents and warrants that: (i) it has the power and
authority to enter into this Agreement; (ii) to the knowledge of AVI, there are
no existing or threatened actions, suits or claims pending with respect to the
subject matter hereof or the right of AVI to enter into and perform its
obligations under this Agreement; (iii) it has taken all necessary action on its
part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder; (iv) this Agreement has been duly
executed and delivered on behalf of it, and constitutes a legal, valid, binding
obligation, enforceable against it in accordance with the terms hereof; (v) the
execution and delivery of this Agreement and the performance of its obligations
hereunder do not conflict with or violate any requirement of applicable laws or
regulations and do not conflict with, or constitute a default under, any
contractual obligation of it; and (vi) it will not knowingly take any action, or
fail to take any action, under this Agreement that will cause a breach of the
GenPharm Cross License Agreement or the XT Master Research and License
Agreement.
7.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, ABX MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND
REGARDING THE MATERIALS, PRODUCTS OR LICENSED TECHNOLOGY, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, AND VALIDITY OF TECHNOLOGY OR PATENT
CLAIMS, ISSUED OR PENDING. ALL XENOMOUSE ANIMALS AND OTHER MATERIALS PROVIDED TO
AVI PURSUANT TO THE RESEARCH COLLABORATION AGREEMENT OR THIS AGREEMENT ARE
PROVIDED "AS IS."
8. TERM; TERMINATION
8.1 Term. This Agreement shall commence on the Effective Date and,
unless earlier terminated pursuant to Article 3 above or this Article 8, shall
continue in effect until October 1, 1999.
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8.2 Termination for Breach. In the event that a party shall have
materially breached or defaulted in the performance of any of its material
obligations hereunder, and such breach or default shall have continued for
thirty (30) days after written notice of such breach was provided to the
breaching party by the nonbreaching party, the nonbreaching party shall have the
right at its option to terminate this Agreement effective at the end of such
thirty (30) day period.
8.3 Termination by AVI. AVI may terminate this Agreement at any time
upon ninety (90) days written notice to ABX.
8.4 Effect of Termination; Accrued Rights and Survival of Terms.
Termination or expiration of this Agreement for any reason shall be without
prejudice to any rights which shall have accrued to the benefit of a party prior
to such termination or expiration. Without limiting the foregoing, Articles 4, 5
and 6 and Sections 2.2 and 7.3 of this Agreement shall survive any expiration or
termination of this Agreement.
9. MISCELLANEOUS PROVISIONS
9.1 Governing Laws. This Agreement shall be governed by, interpreted and
construed in accordance with the laws of the State of California, without regard
to conflicts of law principles.
9.2 Waiver. No waiver by a party hereto of any breach or default of any
of the covenants or agreements herein set forth shall be deemed a waiver as to
any subsequent and/or similar breach or default.
9.3 Assignment. Neither this Agreement nor any right or obligation
hereunder may be assigned or delegated, in whole or part, by either party
without the prior express written consent of the other; provided, however, that
either party may, without the written consent of the other, assign this
Agreement and its rights and delegate its obligations hereunder in connection
with the transfer or sale of all or substantially all of its business, or in the
event of its merger, consolidation, change in control or similar transaction.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement. Any purported assignment in violation of this Section 9.3 shall be
void. Notwithstanding the foregoing, ABX shall not be obligated without its
consent to send XenoMouse Animals to any party other than AVI, nor shall AVI
have the right to transfer XenoMouse Animals to any other party without ABX's
prior written consent. The terms and conditions of this Agreement shall be
binding upon and inure to the benefit of the permitted successors and assigns of
the parties.
9.4 Independent Contractors. The relationship of the parties hereto is
that of independent contractors. The parties hereto are not deemed to be agents,
partners or joint venturers of the others for any purpose as a result of this
Agreement or the transactions contemplated thereby.
9.5 Further Actions. Each party agrees to execute, acknowledge and
deliver such further instruments and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
9.6 Notices. All requests and notices required or permitted to be given
to the parties hereto shall be given in writing, shall expressly reference the
section(s) of this Agreement to which they pertain, and shall be delivered to
the other party, effective on receipt, at the appropriate address
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as set forth below or to such other addresses as may be designated in writing by
the parties from time to time during the term of this Agreement.
If to ABX:
Abgenix, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attn: President
with a copy to:
Pillsbury Madison & Sutro LLP
000 Xxxx Xxxxxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxx
If to AVI:
AVI BioPharma, Inc.
Xxx XX Xxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxxx, Xxxxxx 00000
Attn: President
9.7 No Implied Licenses. Only licenses and rights granted expressly
herein shall be of legal force and effect. No license or other right shall be
created hereunder by implication, estoppel or otherwise.
9.8 Force Majeure. Nonperformance of a party (other than for the payment
of money) shall be excused to the extent that performance is rendered impossible
by strike, fire, earthquake, flood, governmental acts or orders or restrictions,
failure of suppliers, or any other reason where failure to perform is beyond the
reasonable control and not caused by the negligence, intentional conduct or
misconduct of the nonperforming party.
9.9 No Consequential Damages. IN NO EVENT SHALL A PARTY HERETO BE LIABLE
FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT
OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION LOST
PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF
ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 9.9 IS INTENDED TO LIMIT OR
RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.
9.10 Third Party Rights. Notwithstanding anything to the contrary in
this Agreement, the grant of rights by ABX under this Agreement shall be subject
to and limited in all respects by the terms of the applicable ABX In-License(s)
pursuant to which ABX acquired any Licensed Technology, and all rights or
sublicenses granted under this Agreement shall be limited to the extent that ABX
may grant such rights and sublicenses under such ABX In-Licenses. Additionally,
and without limiting the foregoing, the rights granted to AVI hereunder,
including without
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limitation any grant of "exclusive" rights, shall be subject to the rights
granted to or retained by GenPharm under the GenPharm Cross License Agreement.
9.11 Complete Agreement. This Agreement constitutes the entire
agreement, both written and oral, among the parties with respect to the subject
matter hereof, and that all prior representations, understandings and agreements
regarding the subject matter hereof, either written or oral, expressed or
implied, shall be abrogated, canceled, and are null and void and of no effect,
including, without limitation, the Research Collaboration Agreement (except for
those provisions of the Research Collaboration Agreement that expressly survive
pursuant to the terms thereof, including without limitation Sections 2(a) (other
than the first sentence thereof), 3, 5, 6, 7 and 10 thereof). No amendment or
change hereof or addition hereto shall be effective or binding on the parties
unless reduced to writing and executed by the respective duly authorized
representatives of the parties.
9.12 Counterparts. This Agreement may be executed in counterparts, each
of which shall be deemed to be an original and together shall be deemed to be
one and the same agreement.
9.13 Headings. The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their respective duly authorized officers as of the day and year
first above written.
ABGENIX, INC.
By: /s/ Xxxxxxx X. Xxxxx
-------------------------------------
(Signature)
Xxxxxxx X. Xxxxx, Ph.D.
-------------------------------------
(Printed Name)
Vice President, Corporate Development
-------------------------------------
(Title)
AVI BIOPHARMA, INC.
By: /s/ Xxxxx X. Xxxxxx
-------------------------------------
(Signature)
Xxxxx X. Xxxxxx, Ph.D.
-------------------------------------
(Printed Name)
Chief Executive Officer
-------------------------------------
(Title)
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EXHIBIT A
ABX Materials and Information
[*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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EXHIBIT B
ABX PATENT RIGHTS
I. Pursuant to the XT Master Research and License Agreement
A. Any (i) of the patent applications listed in the following Table:
[*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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[*]
and patents issuing thereon, (ii) continuations, divisionals,
reexamination certificates, reissues, or extensions thereof, and
(iii) any foreign counterparts issued or issuing on any of (i)
or (ii) above.
B. Pursuant to the License Agreement by and between [*]
C. Pursuant to the Agreement between [*]
D. Pursuant to the Material Transfer and License Agreement by and
between [*]
E. Pursuant to Agreements between [*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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[*]
II. Pursuant to the GenPharm Cross License Agreement
A. [*], including (i) any continuations, continuations-in-part,
patents of addition, divisionals, reexamination certificates,
reissues or extensions, including supplemental protection
certificates thereof, (ii) any patents issuing from such
application or upon an application under (i), and (iii) foreign
counterparts applied for, issued, or issuing on such application
or any of (i) or (ii).
B. [*], including (i) any continuations, continuations-in-part,
patents of addition, divisionals, reexamination certificates,
reissues or extensions, including supplemental protection
certificates thereof, (ii) any patents issuing from such
application or upon an application under (i), and (iii) foreign
counterparts applied for, issued, or issuing on such application
or any of (i) or (ii).
C. Pursuant to a License Agreement [*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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EXHIBIT C
PRODUCT LICENSE AGREEMENT
THIS PRODUCT LICENSE AGREEMENT (this "Agreement"), effective as of
_____, 1999 (the "Effective Date"), is made by and between ABGENIX, INC., a
Delaware corporation ("ABX"), having a place of business at 0000 Xxxxxxxxx
Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000, and AVI BIOPHARMA, INC., an Oregon
corporation ("AVI"), having a place of business at Xxx XX Xxxxxxxx Xxxxxx, Xxxxx
0000, Xxxxxxxx, Xxxxxx 00000, with respect to the following facts:
RECITALS
WHEREAS, AVI and ABX have entered into the Research License and Option
Agreement (as defined below).
WHEREAS, AVI has exercised rights under the Research License and Option
Agreement to acquire from ABX a license or sublicense, as the case may be, under
the Licensed Technology to commercialize Products (as defined below) in the
Field (as defined below) on the terms and conditions herein.
NOW, THEREFORE, for and in consideration of the covenants, conditions,
and undertakings hereinafter set forth, it is agreed by and between the parties
as follows:
1. DEFINITIONS.
For purposes of this Agreement, the terms set forth in this Article
shall have the meanings set forth below. Any capitalized term used, but not
defined, in this Agreement shall have the respective meanings set forth in the
Research License and Option Agreement.
1.1 "ABX Know-How" shall mean, collectively, all inventions,
discoveries, data, information, methods, techniques, technology and other
results, whether or not patentable but which are not generally known, regarding
(a) methods and techniques of immunizing the XenoMouse(TM) Animals to the
Antigen which are disclosed by ABX to AVI pursuant to the Research Collaboration
Agreement, the Research License and Option Agreement or this Agreement, and (b)
ABX Materials and ABX Inventions. All ABX Know-How shall be Confidential
Information of ABX.
1.2 "ABX Patent Rights" shall mean, collectively, (a) all patents and
patent applications listed on Attachment A and any foreign counterparts claiming
priority thereof; (b) all patent applications heretofore or hereafter filed in
any country which claim ABX Materials delivered to AVI or ABX Inventions; (c)
all patents that have issued or in the future issue from any of the foregoing
patent applications, including without limitation utility, model and design
patents and certificates of invention; and (d) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications.
24
1.3 "Affiliate" shall mean, with respect to any person or entity, any
other person or entity which controls, is controlled by or is under common
control with such person or entity. A person or entity shall be regarded as in
control of another entity if it owns or controls at least fifty percent (50%) of
the equity securities of the subject entity entitled to vote in the election of
directors (or, in the case of an entity that is not a corporation, for the
election of the corresponding managing authority).
1.4 "Antibody" shall mean a composition comprising (a) a whole antibody,
or any fragment thereof, derived from the XenoMouse Animals, or (b) a whole
antibody, or any fragment thereof, which is derived from a whole antibody, or
any fragment thereof, which itself is derived from the XenoMouse Animals (or
from the nucleotide sequences that encode, or amino acid sequences of, a whole
antibody, or any fragment thereof, derived from the XenoMouse Animals).
1.5 "Antigen" shall mean (beta) human chorionic gonadotropin
((beta)HCG).
1.6 "Confidential Information" shall mean, with respect to a party, all
information of any kind whatsoever (including without limitation, compilations,
data, formulae, models, patent disclosures, procedures, processes, projections,
protocols, results of experimentation and testing, specifications, strategies
and techniques), and all tangible and intangible embodiments thereof of any kind
whatsoever (including without limitation, apparatus, biological or chemical
materials, animals, cells, compositions, documents, drawings, machinery, patent
applications, records, reports), which is owned or controlled by such party, is
disclosed by such party to the other party and (if disclosed in writing or other
tangible medium) is marked or identified as confidential at the time of
disclosure to the receiving party or (if otherwise disclosed) is identified as
confidential at the time of disclosure to the receiving party and described as
such in writing within thirty (30) days after such disclosure. Notwithstanding
the foregoing, Confidential Information of a party shall not include information
which the receiving party can establish by written documentation (a) to have
been publicly known prior to disclosure of such information by the disclosing
party to the receiving party, (b) to have become publicly known, without fault
on the part of the receiving party, subsequent to disclosure of such information
by the disclosing party to the receiving party, (c) to have been received by the
receiving party at any time from a source, other than the disclosing party,
rightfully having possession of and the right to disclose such information free
of confidentiality obligations, (d) to have been otherwise known by the
receiving party free of confidentiality obligations prior to disclosure of such
information by the disclosing party to the receiving party, or (e) to have been
independently developed by employees or agents of the receiving party without
access to or use of such information disclosed by the disclosing party to the
receiving party. The parties acknowledge that the foregoing exceptions shall be
narrowly construed and that the obligations imposed upon each party under
Section 7 below shall be relieved solely with respect to such Confidential
Information of the disclosing party which falls within the above exceptions and
not with respect to related portions, other combinations, or characteristics of
the Confidential Information of the disclosing party including, without
limitation, advantages, operability, specific purposes, uses and the like.
1.7 "Derived" or "derived" shall mean obtained, developed, created,
synthesized, designed, derived or resulting from, based upon or otherwise
generated (whether directly or indirectly, or in whole or in part).
1.8 "Excluded Technology" shall mean, collectively, (a) all patent
rights, know-how
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or other intellectual property rights or technology of ABX in or to (i) all
antigens other than the Antigen, including without limitation (A) compositions
of such antigens or of Genetic Materials that encode such antigens; (B) uses of
such antigens; (C) antibodies or other compositions that bind to such antigens,
Genetic Materials that encode such antibodies or compositions, and Antibody
Cells that express, secrete, or contain such antibodies, Genetic Materials or
compositions; and (D) uses of such antibodies, Genetic Materials or
compositions; (ii) methods to discover novel antigens; and (iii) methods of
using antigens other than to create antibodies; (b)(i) all patent applications
heretofore or hereafter filed in any country which claim ABX Materials (except
for those described in clause (a) of Section 1.4 of the Research License and
Option Agreement) or ABX Inventions; (ii) all patents that have issued or in the
future issue from any of the foregoing patent applications, including without
limitation utility, model and design patents and certificates of invention; and
(iii) all divisionals, continuations, continuations-in-part, reissues, renewals,
extensions or additions to any such patents and patent applications; and (c)
inventions, discoveries, data, information, methods, techniques, technology and
other results, whether or not patentable but which are not generally known,
regarding ABX Materials (except for those described in clause (a) of Section 1.4
of the Research License and Option Agreement) and ABX Inventions.
1.9 "Field" shall mean the use of Products for human medical purposes.
1.10 "Genetic Material" shall mean a nucleotide sequence, including DNA,
RNA, and complementary and reverse complementary nucleotide sequences thereto,
whether coding or noncoding and whether intact or a fragment.
1.11 "GenPharm Cross License Agreement" shall mean that certain Cross
License Agreement entered into by and between ABX, JTI, XT, Cell Genesys, Inc.,
and GenPharm International, Inc. effective as of March 26, 1997, as the same may
be amended from time to time.
1.12 "IND" shall mean an Investigational New Drug application filed with
Food and Drug Administration in the United States, or any similar filing with
any foreign regulatory authority, to commence human clinical testing of any
Product in any country in the Territory.
1.13 "JTI" shall mean Japan Tobacco Inc., a Japanese corporation
1.14 "Licensed Technology" shall mean ABX's rights in the ABX Patent
Rights, ABX Know-How, Research Program Patent Rights and Research Program
Know-How; provided, however, that the Licensed Technology (a) is all to the
extent and only to the extent that ABX has the right to grant (sub)licenses
thereunder (including without limitation to the extent permitted under the
applicable ABX In-Licenses); (b) is expressly subject to the ABX In-Licenses;
and (c) shall exclude the Excluded Technology.
1.15 "Net Sales" shall mean [*]. Net Sales shall not include [*]
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* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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[*] In the event that a Product is sold in combination as a single product with
another product or component, Net Sales from such combination sales for purposes
of calculating the amount due under this Agreement shall be calculated by [*]
1.16 "Patent Claim" shall mean a claim of a pending patent application
or issued and unexpired patent included within the Licensed Technology which has
not been held unenforceable or invalid by a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed
for appeal and which has not been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise.
1.17 "Product" shall mean any product comprising (a) an Antibody which
binds to the Antigen, or (b) Genetic Material that encodes such an Antibody
wherein, in respect of each Product, said Genetic Material does not encode
multiple antibodies.
1.18 "Research Collaboration Agreement" shall mean that certain Research
Collaboration Agreement effective as of October 2, 1998, by and between ABX and
AVI.
1.19 "Research License and Option Agreement" shall mean that certain
Research License and Option Agreement effective as of January 4, 1999 by and
between ABX and AVI.
1.20 "Research Program Know-How" shall mean, collectively, all
inventions, discoveries, data, information, methods, techniques, technology and
other results, whether or not patentable but which are not generally known,
regarding Research Program Materials and Research Program Inventions. All
Research Program Know-How shall be Confidential Information of ABX.
1.21 "Research Program Patent Rights" shall mean, collectively, (a) all
patent applications heretofore or hereafter filed in any country which claim
Research Program Materials or Research Program Inventions; (b) all patents that
have issued or in the future issue from any of the foregoing patent
applications, including without limitation utility, model and design patents and
certificates of invention; and (c) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications.
1.22 "Sublicensee" shall mean a third party (other than an Affiliate)
that is granted a sublicense under the Licensed Technology to both make and sell
Products. "Sublicensee" shall also include a third party (other than an
Affiliate) that is granted the right to distribute Product, provided that such
third party is responsible for marketing and promotion of Product within the
applicable territory. As used herein, a "Sublicense" shall mean an agreement or
arrangement pursuant to which such a sublicense or distribution right has been
granted.
1.23 "Territory" shall mean all the countries of the world.
1.24 "XenoMouse" and "XenoMouse Animals" shall mean one or more sterile
male
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transgenic mice provided by ABX to AVI for immunization with the Antigen under
the Research Collaboration Agreement or the Research License and Option
Agreement.
1.25 "XT" shall mean Xenotech, L.P., a California limited partnership.
1.26 "XT Master Research and License Agreement" shall mean that certain
Master Research License and Option Agreement entered into by and among JTI, XT
and Cell Genesys, Inc. effective as of June 28, 1996, and subsequently assigned
to ABX by Cell Genesys, Inc., as the same may be amended from time to time.
1.27 "XT Product License" shall mean a license granted from XT to ABX
pursuant to the terms of the XT Master Research and License Agreement permitting
ABX to commercialize, or to provide rights to a third party to commercialize,
certain Products in one or more territories.
2. LICENSE GRANT
2.1 Grant of Rights.
2.1.1 Subject to the terms and conditions of this Agreement, ABX
hereby grants to AVI an exclusive license or sublicense, as the case may be,
under the Licensed Technology, to make and have made Product anywhere in the
world and to use, sell, lease, offer to sell or lease, import, export, otherwise
transfer physical possession of or otherwise transfer title to Product for use
in the Field in the Territory.
2.1.2 The license granted under Section 2.1.1 above is expressly
subject to the terms and conditions of Section 2.2 of the Research License and
Option Agreement (other than the provisions of subsections (g), (h) and (i)
thereof).
2.2 Sublicenses. AVI may grant Sublicenses under Section 2.1 above. AVI
shall provide ABX with a copy of each such Sublicense promptly after executing
the same; provided, however, that AVI shall have the right to redact any
confidential financial terms from the copy provided to ABX. Any such Sublicense
shall be subject and subordinate to the terms and conditions of this Agreement,
and AVI shall remain responsible for all payments due to ABX hereunder with
respect to Net Sales of Products by any such Sublicensee or its Affiliates.
Notwithstanding the foregoing, AVI shall not have the right to Sublicense any
right under this Agreement in or to a XenoMouse Animal or other transgenic
animal covered by the Licensed Technology.
2.3 No Other Rights. No rights other than those expressly set forth in
this Agreement are granted to AVI hereunder, and no additional rights shall be
deemed granted to AVI by implication, estoppel or otherwise. Without limiting
the foregoing, the rights of AVI under this Agreement are subject and
subordinate in all respects to the provisions of Section 2.2 of the Research
License and Option Agreement (other than the provisions of subsections (g), (h)
and (i) thereof).
3. CONSIDERATION.
3.1 Milestone Payments.
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3.1.1 Amounts. Within thirty (30) days following the achievement
by AVI (or any of its Affiliates or Sublicensees) of each the following
milestones, AVI shall give written notice thereof to ABX and shall pay to ABX
[*]
3.1.2 Terminology. As used herein, [*]. In the event milestone D
above is met, and at such time either one or both of milestones A or B have not
been met, the payment for all such unmet milestone payments shall then be due.
3.2 Royalties.
3.2.1 Royalty Commencement Date. AVI shall notify ABX of the
date of commercial introduction of each Product into each country in the
Territory, which shall mean, on a country-by-country basis in the Territory, the
date of first commercial sale (other than for purposes of obtaining regulatory
approval) of such Product by AVI, its Affiliate or any Sublicensee to an
unaffiliated third party in such country (with respect to each Product in each
country, hereinafter, the "Royalty Commencement Date").
3.2.2 Royalty Rate. In consideration of the license granted
herein, AVI shall pay to ABX a running royalty of [*]
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[*]
3.2.3 Length of Term of Royalty Obligations. AVI's obligation to
pay royalties on Net Sales of each Product under this Agreement shall commence
on a country-by-country basis on the Royalty Commencement Date for such Product
in such country and continue thereafter for such Product on a country-by-country
basis until (a) if, as of the Royalty Commencement Date for such Product in such
country, there exists a Patent Claim in the country where such Product is made,
used or sold that covers (i) AVI's manufacture, use or sale of such Product or
(ii) XenoMouse Animals or their use, such date as no such Patent Claim exists in
the country where such Product is made, used or sold, or (b) otherwise, ten (10)
years after the Royalty Commencement Date for such Product in such country.
3.3 Discounting. If AVI or its Affiliate or Sublicensee sells any
Product to a third party who also purchases other products or services from AVI,
its Affiliate or Sublicensee, AVI agrees not to, and requires its Affiliate and
Sublicensee not to, discount the sales price of the Products to a greater degree
than AVI, its Affiliate or Sublicensee, respectively, generally discounts the
price of its other products to such customer.
3.4 Royalties To Be Paid By ABX. It is understood that, subject to the
terms and conditions of this Agreement, including without limitation AVI's
payment of royalties as set forth herein, ABX will be responsible to make the
royalty payments to third parties as set forth in Attachment B hereto in respect
of Net Sales of Products in accordance with this Agreement.
4. ACCOUNTING AND RECORDS.
4.1 Royalty Reports; Payments, Invoices. After the first commercial sale
of Product on which royalties are required to be paid by AVI under Article 3
above, AVI agrees to make quarterly written reports to ABX within thirty (30)
days after the end of each calendar quarter, stating in each such report the
number, description, and aggregate Net Sales of Product sold during the calendar
quarter upon which a royalty is payable under Article 3 above. These reports may
be combined with reports due under Section 5.4. Concurrently with the making of
such reports, AVI shall pay to ABX all amounts payable pursuant to Article 3
above. All payments to ABX hereunder shall be made in U.S. Dollars to a bank
account designated by ABX.
4.2 Records; Inspection. AVI shall keep (and cause its Affiliates and
Sublicensees to keep) complete, true and accurate books of account and records
for the purpose of determining the royalty amounts payable to ABX under this
Agreement. Such books and records shall be kept at the principal place of
business of AVI or its Affiliates or Sublicensees, as the case may be, for at
least three years following the end of the calendar quarter to which they
pertain. Such records of AVI or its Affiliates will be open for inspection
during such three-year period by representatives of ABX (which representatives
may also represent XT) for the purpose of verifying the royalty statements. AVI
shall require each of its Sublicensees to maintain similar books and records and
to open such records for inspection during the same three-year period by a
representative of AVI reasonably satisfactory to ABX on behalf of, and as
required by, ABX for the purpose of verifying the royalty statements. All such
inspections may be made no more than once each calendar year at reasonable times
mutually agreed by AVI and ABX. The representative of ABX will be obliged to
execute a reasonable confidentiality agreement prior to commencing any such
inspection. Inspections conducted under this Section 4.2 shall be at the expense
of ABX, unless a variation or
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error producing an increase [*] of the amount stated for any period is
established in the course of any such inspection, whereupon all costs relating
to the audit of such period will be paid by AVI.
4.3 Payment Method. All payments due hereunder shall be made in U.S.
dollars, and shall be made by bank wire transfer in immediately available funds
to an account designed by ABX.
4.4 Currency Conversion. If any currency conversion shall be required in
connection with the calculation of royalties hereunder, such conversion shall be
made using the selling exchange rate for conversion of the foreign currency into
U.S. Dollars, quoted for current transactions reported in The Wall Street
Journal for the last business day of the calendar quarter to which such payment
pertains.
4.5 Late Payments. Any payments due from AVI that are not paid on the
date such payments are due under this Agreement shall bear interest at the
lesser of (i) the prime rate as reported by the Bank of America in San
Francisco, California on the date such payment is due, plus an additional [*],
or (ii) the maximum rate permitted by applicable law, in each case
calculated on the number of days such payment is delinquent. This Section 4.5
shall in no way limit any other remedies available to any party.
4.6 Withholding Taxes. All payments required to be made pursuant to
Article 3 hereof shall be without deduction or withholding for or on account of
any taxes or similar governmental charge imposed by a jurisdiction, such taxes
being referred to herein as "Withholding Taxes." Withholding Taxes shall be the
sole responsibility of the withholding party. The withholding party shall
provide a certificate evidencing payment of any Withholding Taxes hereunder.
5. DILIGENCE.
5.1 General. AVI shall use its diligent efforts to actively research,
develop and obtain regulatory approvals to market in major markets throughout
the world at least one Product hereunder as expeditiously as possible, and
following such approval to maximize Net Sales of such Product.
5.2 Filing of IND. Without limiting Section 5.1 above, AVI or its
Sublicensee shall file an IND with the U.S. FDA for one or more Products under
this Agreement [*]; provided, however, prior to the expiration of such [*], if
AVI requests in writing that ABX extend such time period, and provides ABX with
reasonably satisfactory evidence that AVI has diligently endeavored to file such
an IND within such [*], and pays to ABX the [*], then ABX shall extend such time
period for an additional [*]. If AVI pays such extension fee to ABX as set forth
above, AVI shall have the right to [*]. After the filing of an IND for a
Product, AVI, or its Sublicensee, shall be required to have an active IND and to
be actively and diligently conducting clinical trials in pursuit of regulatory
approval
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for the Product in the United States until such Product may be sold commercially
in the United States.
5.3 Failure to Meet Due Diligence Obligation. If the diligence
requirements set forth in Section 5.1 and 5.2 are not met by AVI (or its
Sublicensees), ABX shall have the right to terminate this Agreement pursuant to
Section 9.2 below.
5.4 Research and Development Reports. AVI shall keep (or cause to be
kept) complete and accurate records of its research, development and
commercialization activities under this Agreement. AVI shall maintain (or cause
to be maintained) such records in sufficient detail, and in accordance with good
scientific practices. AVI shall keep ABX fully informed as to its research,
development and commercialization activities hereunder. Without limiting the
foregoing, within thirty (30) days of the end of each calendar quarter, AVI
shall provide to ABX a reasonably detailed written report regarding such
research, development and commercialization activities and the status thereof.
5.5 No Conflicts.
5.5.1 Other Products. During the term of this Agreement, AVI
shall not directly or indirectly sell or commercialize for human medical use, or
conduct research or development toward the human medical use of any product
(other than the Products), comprising (a) a human, humanized, or chimeric
antibody, human, humanized, or chimeric antibody fragment or amino acid sequence
derived from a human, humanized or chimeric antibody, in each case which binds
to the Antigen, (b) Genetic Material that encodes such any such composition, or
(c) any other chemical or biological material derived by AVI from XenoMouse
Animals immunized with the Antigen strictly in accordance with the terms and
conditions of the Research Collaboration Agreement, the Research License and
Option Agreement or this Agreement.
5.5.2 Discounting. In the event that AVI or its Affiliates sells
Product to a third party who also purchases other products or services from AVI
or its Affiliate, and AVI or its Affiliates discounts the purchase price of the
Product to a greater degree than AVI or its Affiliate, respectively, generally
discounts the price of their other products to such customer, then in such case
the Net Sales for the sale of Products to such third party shall be deemed to
equal the arm's length price that third parties would generally pay for the
Product alone when not purchasing any other product or service from AVI or its
Affiliate. For purposes of this provision "discounting" includes establishing
the list price at a lower-than-normal level.
5.6 Gene Therapy Applications. AVI's intention as of the Effective Date
is to commercialize a Product hereunder for an application other than Gene
Therapy before commercializing a Product hereunder for a Gene Therapy
application. It is understood, however, that AVI may or may not also intend to
develop and sell Products for use in Gene Therapy, and that such Gene Therapy
application may ultimately be commercialized before a Product is commercialized
hereunder for a non-Gene Therapy application. As used herein, "Gene Therapy"
shall mean [*]
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[*]
6. INTELLECTUAL PROPERTY.
6.1 Licensed Technology. Subject to Sections 6.2 and 6.6, ABX or its
licensor, as they may agree, shall have the right to control the preparing,
filing, prosecuting and maintaining of patents and patent applications worldwide
within the Licensed Technology (other than the Research Program Patent Rights)
and conducting any interferences, oppositions, reexaminations, or requesting
reissues or patent term extensions with respect to patents and patent
applications worldwide within the Licensed Technology (other than the Research
Program Patent Rights).
6.2 Research Program Patent Rights. Notwithstanding anything to the
contrary in this Article 6, AVI shall have the right and responsibility (but not
the obligation), at AVI's expense, to file, prosecute, maintain and enforce all
patent applications and patents (and to conduct any interferences, oppositions,
or reexaminations thereon, and to request any reissues or patent term extensions
thereof) within the Research Program Patent Rights in accordance with and
subject to the terms and conditions of Article 4 of the Research License and
Option Agreement.
6.3 Enforcement. Subject to Section 6.2 and 6.6, in the event that AVI
becomes aware that any Licensed Technology necessary for the practice of the
license granted herein is infringed or misappropriated by a third party or is
subject to a declaratory judgment action arising from such infringement in each
case with respect to a composition that binds to the Antigen and is competitive
with Products hereunder (an "Infringement"), AVI shall promptly notify ABX. As
between AVI, its Sublicensees and ABX, ABX shall have the exclusive right at its
expense to bring an enforcement proceeding, or defend any declaratory judgment
action, involving any Licensed Technology with respect to an Infringement. ABX
shall keep AVI reasonably informed of the progress of such claim, suit or
proceeding with respect to an Infringement involving enforcement or defense of
the Licensed Technology. Any recovery received by ABX as a result of any such
claim, suit or proceeding shall be used first to reimburse ABX for all expenses
(including attorneys, and professional fees) incurred in connection with such
claim, suit or proceeding, and the remaining amount (if any) retained by ABX,
after paying amounts ABX is obligated to pay to third parties in respect of such
amount pursuant to applicable ABX In-Licenses shall be divided, to the extent
that the recovery expressly represents lost profits on sales of Product within
the Field because of the Infringement, in equal shares between ABX and AVI.
Notwithstanding the foregoing, if ABX notifies AVI that it does not desire to
pursue an enforcement action, or defend a declaratory judgment action, with
respect to a substantial and continuing Infringement, then, to the extent such
action involves a Product composition of matter claim, AVI may at its expense
bring or defend
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such action in consultation with ABX; provided, however, that (i) ABX shall have
the right to join such proceeding at any time at its own expense, (ii) AVI shall
not admit the invalidity or unenforceability of any patent rights within the
Licensed Technology without ABX's prior written consent, and (iii) if ABX does
not join the action, any recovery obtained by AVI shall be used first to
reimburse AVI for all expenses (including attorneys, and professional fees)
incurred in connection with such claim, suit or proceeding, and the remaining
amount (if any) retained by AVI after reimbursing ABX for any amounts ABX is
obligated to pay to third parties in respect of such amount pursuant to
applicable ABX In-Licenses shall be divided evenly between ABX and AVI.
6.4 Infringement Claims. Subject to Section 6.6, if the production, sale
or use of Product pursuant to this Agreement results in any claim, suit or
proceeding alleging patent infringement against AVI (or its Affiliates or
Sublicensees), AVI shall promptly notify ABX thereof in writing setting forth
the facts of such claim in reasonable detail. AVI shall keep ABX reasonably
informed of all material developments in connection with any such claim, suit or
proceeding as it relates to the Licensed Technology. Notwithstanding the above,
AVI shall not admit the invalidity of any patent within the Licensed Technology
without written consent from ABX.
6.5 Patent Marking. AVI agrees to xxxx and have its Affiliates and all
Sublicensees xxxx all Products sold pursuant to this Agreement in accordance
with the applicable statutes or regulations in the country or countries of
manufacture and sale thereof.
6.6 Limitation. Notwithstanding any other provision in this Article 6,
the parties acknowledge and understand that (i) ABX shall not be obligated to
prepare, file, prosecute, and maintain patents and patent applications, or to
bring or pursue enforcement proceedings or defend declaratory judgment actions
regarding the Licensed Technology if, and to the extent that, ABX is not
entitled to do so under one or more ABX In-Licenses, and (ii) any rights
conveyed under this Article 6 permitting AVI to prepare, file, prosecute and
maintain certain patents and patent applications, or to bring and pursue
enforcement proceedings, or defend declaratory judgment actions, regarding the
Licensed Technology, shall be subject to all applicable ABX In-Licenses, and are
conveyed only to the extent permitted under such agreements.
7. CONFIDENTIALITY.
7.1 Confidentiality. Except as expressly provided herein, AVI and ABX
each shall keep completely confidential and shall not publish or otherwise
disclose and shall not use for any purpose any Confidential Information of the
other until the date five (5) years following the expiration or termination of
this Agreement.
7.2 Permitted Disclosure. Notwithstanding Section 7.1 above, each party
may nevertheless disclose the other party's Confidential Information to the
extent such disclosure is required by applicable law, regulation or court order,
provided that if a party is so required to make any such disclosure of the other
party's Confidential Information, other than pursuant to a confidentiality
agreement, it will give reasonable advance notice to the other party of such
disclosure requirement and will use efforts consistent with prudent business
judgment to secure confidential treatment of such information prior to its
disclosure (whether through protective orders or confidentiality agreements or
otherwise). The expiration of AVI's obligations under Section 7.1 above shall
not be deemed to limit AVI's obligations under Section 2.2 of the Research
License and
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Option Agreement.
7.3 Terms of Agreement. Neither party shall disclose any terms or
conditions of this Agreement to any third party without the prior consent of the
other party; provided, however, that a party may disclose the terms or
conditions of this Agreement, (i) on a need-to-know basis to its legal and
financial advisors to the extent such disclosure is reasonably necessary in
connection with such party's activities as expressly permitted by this
Agreement, (ii) to a third party in connection with (A) an equity investment in
such party by a third party, (B) a merger, consolidation or similar transaction
entered into by such party, or (C) the sale of all or substantially all of the
assets of such party, and (iii) as may, in the reasonable opinion of such
party's counsel, be required by applicable law, regulation or court order,
including without limitation, a disclosure in connection with such party's
filing of a registration statement or other filing with the United States
Securities and Exchange Commission (in which event such party will first consult
with the other party with respect to such disclosure). Notwithstanding the
foregoing, prior to execution of this Agreement, the parties shall agree upon
the substance of information that can be used to describe the terms of this
transaction, and each party may disclose such information, as modified by
written agreement of Abgenix and AVI from time to time, without the consent of
the other. Additionally, notwithstanding the foregoing, ABX shall have the right
in its sole discretion to disclose (a) the identity of the Antigen upon filing
of an IND for a Product, and (b) the achievement of each milestone described in
Section 3.1 above, the grant of regulatory approval of each Product in each
country and the market launch of each Product in each country, in each case upon
the occurrence of the same.
8. INDEMNIFICATION.
8.1 AVI. AVI shall indemnify and hold harmless ABX, and its directors,
officers, employees and agents, from and against all losses, liabilities,
damages and expenses, including reasonable attorneys' fees and costs
(collectively, "Liabilities"), resulting from any claims, demands, actions or
other proceedings by any third party arising from (i) the material breach of any
representation, warranty or covenant by AVI under this Agreement, (ii) the
manufacture, use, sale, handling or storage by AVI, its Affiliates or
Sublicensees of the Products (without regard to culpable conduct), or (iii) any
use by AVI, its Affiliates or Sublicensees of the Confidential Information of
ABX; provided, however, that AVI shall not be obligated to indemnify or hold
harmless ABX for such Liabilities to the extent that such Liabilities arise from
the gross negligence or willful misconduct of ABX.
8.2 ABX. ABX shall indemnify and hold harmless AVI, and its directors,
officers, employees and agents, from and against all Liabilities resulting from
any claims, demands, actions or other proceedings by any third party arising
from (i) the material breach of any representation, warranty or covenant by ABX
under this Agreement, or (ii) any use by ABX of the Confidential Information of
AVI; provided, however, that ABX shall not be obligated to indemnify or hold
harmless AVI for such Liabilities to the extent that such Liabilities arise from
the gross negligence or willful misconduct of AVI.
8.3 Procedure. If a party (an "Indemnitee") intends to claim
indemnification under this Article 8, it shall promptly notify the indemnifying
party (the "Indemnitor") in writing of any claim, demand, action or other
proceeding for which the Indemnitee intends to claim such indemnification, and
the Indemnitor shall have the right to participate in, and, to the extent the
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Indemnitor so desires, to assume the defense thereof with counsel mutually
satisfactory to the parties; provided, however, that an Indemnitee shall have
the right to retain its own counsel, with the fees and expenses to be paid by
the Indemnitor, if representation of such Indemnitee by the counsel retained by
the Indemnitor would be inappropriate due to actual or potential differing
interests between such Indemnitee and any other party represented by such
counsel in such proceeding. The indemnity agreement in this Article 8 shall not
apply to amounts paid in settlement of any claim, demand, action or other
proceeding if such settlement is effected without the consent of the Indemnitor,
which consent shall not be withheld or delayed unreasonably. The failure to
deliver written notice to the Indemnitor within a reasonable time after the
commencement of any such action, if prejudicial to its ability to defend such
action, shall relieve such Indemnitor of any liability to the Indemnitee under
this Article 8, but the omission so to deliver written notice to the Indemnitor
shall not relieve it of any liability that it may have to any party claiming
indemnification otherwise than under this Article 8. The party claiming
indemnification under this Article 8, its employees and agents, shall reasonably
cooperate with the Indemnitor and its legal representatives in the investigation
of any claim, demand, action or other proceeding covered by this
indemnification.
8.4 Insurance. AVI shall maintain insurance, including product liability
insurance, with respect to development, manufacture and sales of Products in
such amount as AVI customarily maintains with respect to the development,
manufacture and sale of its other products. ABX shall be named as an additional
insured on any such AVI policies. AVI shall maintain such insurance for so long
as it continues to develop, manufacture or sell any Products, and thereafter for
so long as AVI customarily maintains insurance for itself covering the
development, manufacture and sale of its other products.
9. REPRESENTATIONS AND WARRANTIES.
9.1 ABX. ABX represents and warrants that: (i) it has the power and
authority to enter into this Agreement; (ii) to the knowledge of ABX, there are
no existing or threatened actions, suits or claims pending with respect to the
subject matter hereof or the right of ABX to enter into and perform its
obligations under this Agreement; (iii) it has taken all necessary action on its
part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder; (iv) this Agreement has been duly
executed and delivered on behalf of it, and constitutes a legal, valid, binding
obligation, enforceable against it in accordance with the terms hereof; and (v)
the execution and delivery of this Agreement and the performance of its
obligations hereunder do not conflict with or violate any requirement of
applicable laws or regulations and do not conflict with, or constitute a default
under, any contractual obligation of it.
9.2 AVI. AVI represents and warrants that: (i) it has the power and
authority to enter into this Agreement; (ii) to the knowledge of AVI, there are
no existing or threatened actions, suits or claims pending with respect to the
subject matter hereof or the right of AVI to enter into and perform its
obligations under this Agreement; (iii) it has taken all necessary action on its
part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder; (iv) this Agreement has been duly
executed and delivered on behalf of it, and constitutes a legal, valid, binding
obligation, enforceable against it in accordance with the terms hereof; (v) the
execution and delivery of this Agreement and the performance of its obligations
hereunder do not conflict with or violate any requirement of applicable laws or
regulations and do not conflict with, or constitute a default under, any
contractual obligation of it; and (vi) it will not take any action, or
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fail to take any action, under this Agreement that will cause a breach of the
GenPharm Cross License Agreement, the XT Master Research and License Agreement
or the XT Product License.
9.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, ABX MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND
REGARDING ABX MATERIALS, PRODUCTS OR THE LICENSED TECHNOLOGY, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, AND VALIDITY OF TECHNOLOGY OR PATENT
CLAIMS, ISSUED OR PENDING. ALL XENOMOUSE ANIMALS AND OTHER MATERIALS PROVIDED TO
AVI PURSUANT TO THE RESEARCH COLLABORATION AGREEMENT OR THE RESEARCH LICENSE AND
OPTION AGREEMENT ARE PROVIDED "AS IS."
10. TERM AND TERMINATION.
10.1 Term. The term of this Agreement shall commence on the Effective
Date and, unless earlier terminated as provided in this Article 10, shall
continue in full force and effect on a Product-by-Product and country-by-country
basis until the expiration of all royalty obligations pursuant to this Agreement
for such Product in such country. Following the expiration, but not earlier
termination, of this Agreement on a Product-by-Product and country-by-country
basis, AVI shall have a fully-paid up, perpetual, non-exclusive license under
the ABX Know-How solely to commercialize such Product in such country.
10.2 Termination for Breach. In the event that a party shall have
materially breached or defaulted in the performance of any of its material
obligations hereunder, and such breach or default shall have continued for
thirty (30) days after written notice of such breach was provided to the
breaching party by the nonbreaching party, the nonbreaching party shall have the
right at its option to terminate this Agreement effective at the end of such
thirty (30) day period.
10.3 Termination by AVI. AVI may terminate this Agreement and the
license granted herein at any time, by providing ABX ninety (90) days written
notice.
10.4 Effect of Termination.
10.4.1 Accrued Obligations. Termination of this Agreement for
any reason shall not release either party hereto from any liability which at the
time of such termination has already accrued to the other party or which is
attributable to a period prior to such termination, nor preclude either party
from pursuing any rights and remedies it may have hereunder or at law or in
equity which accrued are based upon events occurring prior to such termination.
10.4.2 Stock in Hand; Sublicenses. In the event this Agreement
is terminated for any reason, AVI and its Affiliates and Sublicensees shall have
the right to sell or otherwise dispose (consistent with all applicable
regulations and law and subject to Articles 3 and 4 of this Agreement) of the
stock of any Product subject to this Agreement then on hand. Upon termination of
this Agreement by ABX for any reason, any sublicense granted by AVI hereunder
shall survive, provided that upon request by ABX, such Sublicensee promptly
agrees in writing to be bound by the applicable terms of this Agreement.
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10.4.3 Survival. The provisions of Articles 3, 4, 7, 8 and 11
and Section 9.3 shall survive the expiration and any termination of this
Agreement for any reason.
11. MISCELLANEOUS.
11.1 Governing Laws. This Agreement shall be governed by, interpreted
and construed in accordance with the laws of the State of California, without
regard to conflicts of law principles.
11.2 Waiver. No waiver by any party hereto of any breach or default of
any of the covenants or agreements herein set forth shall be deemed a waiver as
to any subsequent and/or similar breach or default.
11.3 Assignments. Neither this Agreement nor any right or obligation
hereunder may be assigned or delegated, in whole or part, by either party
without the prior express written consent of the other; provided, however, that
either party may, without the written consent of the other, assign this
Agreement and its rights and delegate its obligations hereunder in connection
with the transfer or sale of all or substantially all of its business, or in the
event of its merger, consolidation, change in control or similar transaction.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement. Any purported assignment in violation of this Section 11.3 shall be
void. Notwithstanding the foregoing, ABX shall not be obligated without its
consent to send XenoMouse Animals to any party other than AVI, nor shall AVI
have the right to transfer XenoMouse Animals to any other party without ABX's
prior written consent. The terms and conditions of this Agreement shall be
binding upon and inure to the benefit of the permitted successors and assigns of
the parties.
11.4 Independent Contractors. The relationship of the parties hereto is
that of independent contractors. The parties hereto are not deemed to be agents,
partners or joint venturers of the others for any purpose as a result of this
Agreement or the transactions contemplated thereby.
11.5 Further Actions. Each party agrees to execute, acknowledge and
deliver such further instruments and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
11.6 Notices. All requests and notices required or permitted to be given
to the parties hereto shall be given in writing, shall expressly reference the
section(s) of this Agreement to which they pertain, and shall be delivered to
the other party, effective on receipt, at the appropriate address as set forth
below or to such other addresses as may be designated in writing by the parties
from time to time during the term of this Agreement.
If to ABX:
Abgenix, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attn: President
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with a copy to:
Pillsbury Madison & Sutro LLP
000 Xxxx Xxxxxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxx
If to AVI:
AVI BioPharma, Inc.
Xxx XX Xxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxxx, Xxxxxx 00000
Attn: President
11.7 No Implied Licenses. Only licenses and rights granted expressly
herein shall be of legal force and effect. No license or other right shall be
created hereunder by implication, estoppel or otherwise.
11.8 Export Laws. Notwithstanding anything to the contrary contained
herein, all obligations of ABX and AVI are subject to prior compliance with
United States export regulations and such other United States laws and
regulations as may be applicable, and to obtaining all necessary approvals
required by the applicable agencies of the government of the United States. AVI
shall be responsible for obtaining such approvals, and shall use efforts
consistent with prudent business judgment to obtain such approvals. ABX agrees
to cooperate reasonably with AVI and provide reasonable assistance to AVI as may
be reasonably necessary to obtain any required approvals.
11.9 Force Majeure. Nonperformance of a party (other than for the
payment of money) shall be excused to the extent that performance is rendered
impossible by strike, fire, earthquake, flood, governmental acts or orders or
restrictions, failure of suppliers, or any other reason where failure to
perform, is beyond the reasonable control and not caused by the negligence,
intentional conduct or misconduct of the nonperforming party.
11.10 No Consequential Damages. IN NO EVENT SHALL A PARTY HERETO BE
LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION
LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 11.10 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY.
11.11 Third Party Rights. Notwithstanding anything to the contrary in
this Agreement, the grant of rights by ABX under this Agreement shall be subject
to and limited in all respects by the terms of the applicable ABX In-License(s)
pursuant to which ABX acquired any Licensed Technology, and all rights or
sublicenses granted under this Agreement shall be limited to the extent that ABX
may grant such rights and sublicenses under such ABX In-Licenses. Additionally,
and without limiting the foregoing, the rights granted to AVI hereunder,
including without
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limitation any grant of "exclusive" rights, shall be subject to the rights
granted to or retained by GenPharm under the GenPharm Cross License Agreement.
11.12 Complete Agreement. This Agreement constitutes the entire
agreement, both written and oral, between the parties with respect to the
subject matter hereof, and that all prior representations, understandings and
agreements regarding the subject matter hereof, either written or oral,
expressed or implied, shall be abrogated, canceled, and are null and void and of
no effect, including without limitation the Research Collaboration Agreement
(except for those provisions of the Research Collaboration Agreement that
expressly survive pursuant to the terms thereof (including without limitation
Sections 2(a) (other than the first sentence thereof), 3, 5, 6, 7, and 10
thereof) and the Research License and Option Agreement (except for those
provisions of the Research License and Option Agreement that either (a)
expressly survive pursuant to the terms thereof (including without limitation
Sections 4, 5, 6, 2.2 and 7.3 thereof), or (b) are expressly referenced in this
Agreement). No amendment or change hereof or addition hereto shall be effective
or binding on either of the parties hereto unless reduced to writing and
executed by the respective duly authorized representatives of ABX and AVI.
11.13 Counterparts. This Agreement may be executed in counterparts, each
of which shall be deemed to be an original and both together shall be deemed to
be one and the same agreement.
11.14 Headings. The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their respective duly authorized officers as of the day and year
first above written.
ABGENIX, INC.
By:
(Signature)
Xxxxxxx X. Xxxxx, Ph.D.
-------------------------------------
(Printed Name)
Vice President, Corporate Development
-------------------------------------
(Title)
AVI BIOPHARMA, INC.
By:
(Signature)
Xxxxx X. Xxxxxx, Ph.D.
-------------------------------------
(Printed Name)
Chief Executive Officer
-------------------------------------
(Title)
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ATTACHMENT A
ABX PATENT RIGHTS
I. Pursuant to the XT Master Research and License Agreement
A. Any (i) of the patent applications listed in the following Table:
[*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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[*]
and patents issuing thereon, (ii) continuations, divisionals,
reexamination certificates, reissues, or extensions thereof, and
(iii) any foreign counterparts issued or issuing on any of (i)
or (ii) above.
B. Pursuant to the License Agreement by and between the [*]
C. Pursuant to the Agreement between the [*]
D. Pursuant to the Material Transfer and License Agreement by and
between [*]
E. Pursuant to Agreements between [*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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[*]
II. Pursuant to the GenPharm Cross License Agreement
A. [*], including (i) any continuations, continuations-in-part,
patents of addition, divisionals, reexamination certificates,
reissues or extensions, including supplemental protection
certificates thereof, (ii) any patents issuing from such
application or upon an application under (i), and (iii) foreign
counterparts applied for, issued, or issuing on such application
or any of (i) or (ii).
B. [*], including (i) any continuations, continuations-in-part,
patents of addition, divisionals, reexamination certificates,
reissues or extensions, including supplemental protection
certificates thereof, (ii) any patents issuing from such
application or upon an application under (i), and (iii) foreign
counterparts applied for, issued, or issuing on such application
or any of (i) or (ii).
C. Pursuant to a License Agreement [*]
------------------
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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ATTACHMENT B
ABX IN-LICENSES
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