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EXHIBIT 10.36
Execution Copy
RESEARCH LICENSE AND OPTION AGREEMENT
This Research License and Option Agreement (this "Agreement"),
effective as of October 30, 1998 (the "Effective Date"), is made by and between
Abgenix, Inc., a Delaware corporation ("ABX"), and Millennium BioTherapeutics,
Inc., a Delaware corporation ("MBio").
RECITALS
A. ABX has rights in certain technology regarding certain strains of
XenoMouse(TM) Animals (as defined below) that are capable of producing human
antibodies upon immunization with antigens;
B. MBio desires to generate human antibodies to the antigen
[*];
C. MBio has immunized XenoMouse Animals with [*] pursuant to
that certain Research Collaboration Agreement between MBio and ABX effective as
of July 15, 1998 (the "RCA"); and
D. ABX is willing to grant to MBio, and MBio desires to obtain, a
license to use XenoMouse Animals solely for immunization with [*] for
research purposes, as described below and on the terms and conditions set forth
herein;
E. ABX additionally is willing to grant to MBio, and MBio desires to
obtain, an option to obtain the Antigen Product License (as defined below) on
the terms and conditions set forth 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:
1.1 "Affiliate" shall mean any entity which controls, is controlled by
or is under common control with ABX, MBio or a Sublicensee. An entity shall be
regarded as in control of another entity if it owns or controls at least fifty
percent (50%) of the shares 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).
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1.2 "Antibody" shall mean a composition comprising a whole antibody or
fragment thereof, said antibody or fragment having been derived in whole or part
from the XenoMouse Animals provided by ABX to MBio pursuant to the RCA or this
Agreement, or having been derived from nucleotide sequences encoding, or amino
acid sequences of, such an antibody or fragment.
1.3 "Antibody Cells" shall mean all cells that contain, express, or
secrete (a) Antibodies or (b) Genetic Materials that encode Antibodies.
1.4 "Antigen" shall mean [*]
1.5 "Antigen Product License" shall mean a license, in the form
attached hereto as Exhibit A, to be granted by ABX to MBio pursuant to Section
3.3 of this Agreement.
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 and
is disclosed by such party to the receiving party and is marked, identified as
or otherwise acknowledged to be confidential at the time of disclosure to the
receiving party. 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 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.
1.7 "Derived" or "derived" shall mean obtained, developed, created,
synthesized, designed, derived or resulting from, based upon or otherwise
generated.
1.8 "Field" shall mean the use of Products for human therapeutic,
preventative
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(prophylactic) and diagnostic medical purposes.
1.9 "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.
1.10 "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.
1.11 "IND" shall mean an Investigational New Drug application filed
with FDA, or any similar filing with any foreign regulatory authority, to
commence human clinical testing of any Product in any country.
1.12 "JTI" shall mean Japan Tobacco Inc., a Japanese corporation.
1.13 "Licensed Technology" shall mean ABX Patent Rights, ABX Know-How
and [*]; provided, however, that Licensed Technology shall not include Excluded
Technology.
1.13.1 "ABX Patent Rights" shall mean (i) the patents and
patent applications listed on Exhibit B hereto and any foreign counterparts
thereto; (ii) the patent applications which claim Joint Materials as defined in
Section 2.1.4(B) or Joint Intellectual Property as defined in Section 4.4; (iii)
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 (iv) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications.
1.13.2 "ABX Know-How" shall mean information discovered,
developed or acquired by ABX prior to the Effective Date regarding methods and
techniques of immunizing the XenoMouse Animals to the Antigen which is disclosed
by ABX to MBio pursuant to this Agreement or the RCA. All ABX Know-How shall be
treated as "Confidential Information" of ABX under Article 5 of this Agreement.
1.13.3 "ABX In-License" shall mean a license, sublicense or
other agreement under which ABX acquired rights to the ABX Patent Rights or the
ABX Know-How.
1.13.4 [*]
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[*]
1.13.5 "Excluded Technology" shall mean any intellectual
property 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 encoding such antigens; (B) uses of such antigens; (C) antibodies or
other compositions that bind to such antigens, Genetic Materials encoding such
antibodies or compositions, and 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;
(iii) methods of using antigens other than to create antibodies; and (iv) ABX
Intellectual Property as defined in Section 4.5.
1.14 "Option" shall have the meaning set forth in Section 3.1.1 below.
1.15 "Product" shall mean any product comprising (i) an Antibody which
binds to the Antigen or (ii) Genetic Material encoding such an Antibody wherein,
in respect of each Product, said Genetic Material does not encode multiple
antibodies.
1.16 [*] shall mean the [*] below.
1.17 "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, and preclinical
development of Products for use in the Field. For purposes of clarification, but
without limitation, the Research Field shall not include (i) the creation,
breeding or development of mice or any transgenic animals, (ii) use in humans of
materials derived in whole or part from the XenoMouse Animals (including without
limitation Products), (iii) use of XenoMouse Animals or materials derived in
whole or part from XenoMouse Animals (including without limitation Products) for
screening or other research, or for any purpose other than the creation,
identification, analysis, research and development of Products for use in the
Field, or (iv) the transfer, sale, lease, offer for sale or lease, or other
transfer of title to or an interest in XenoMouse Animals or any materials
derived in whole or part from the XenoMouse Animals (including without
limitation Products).
1.18 "XenoMouse" and "XenoMouse Animals" shall mean one or more
transgenic mice provided by ABX to MBio for immunization with the Antigen under
either this Agreement or the RCA.
1.19 "Xenotech 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.
1.20 "XT" shall mean Xenotech, L.P., a California limited partnership.
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1.21 "XT-ABX Product License" shall mean a license granted from XT to
ABX pursuant to the terms of the Xenotech Agreement permitting ABX to
commercialize certain Products in one or more territories.
2. SUPPLY OF MICE AND MATERIALS; RESEARCH LICENSE
2.1 Supply of XenoMouse Animals.
2.1.1 XenoMouse Animals. 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 has provided to MBio, solely for use in creating
Antibodies to the Antigen for use in the Research Field, XenoMouse Animals
pursuant to the RCA.
2.1.2 Research. Except as the parties may otherwise agree,
MBio shall be responsible for conducting all research activities involved in the
Research Field, including without limitation immunizations of XenoMouse Animals
with the Antigen, screening of antibodies generated from such immunizations, and
creation of hybridoma cells that produce antibodies to the Antigen.
2.1.3 Payments. MBio shall pay to ABX [*] on December 20,
1998.
2.1.4 Ownership of Materials and Data.
A. ABX Materials. Subject to Section 2.1.4(B)
below, ABX owns and shall own (i) any and all XenoMouse Animals and XenoMouse
Animals immunized with the Antigen and any and all materials derived therefrom
(including without limitation fragments, derivatives, progeny, modifications or
improvements thereto, and derivatives thereof) [*] (the "ABX Materials").
B. Joint Materials. Notwithstanding anything to
the contrary in Section 2.1.4(A), it is understood and agreed that ABX and MBio
own and shall jointly own [*]
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[*] relating to Products resulting from the parties' use of the XenoMouse
Animals or Products in connection with the RCA, this Agreement or the Antigen
Product License (if entered into by the parties) (the "Joint Materials").
C. MBio Materials. Subject to Sections 2.1.4(A)
and 2.1.4(B), MBio owns and shall own [*]
D. Determinations Regarding Materials. In the
event of any good faith dispute between the parties with respect to the proper
categorization of materials under Section 2.1.4(A) through (C), above, the
parties shall attempt to resolve such dispute, first by thirty (30) days'
amicable negotiations, then by referral of the dispute (for thirty (30) days'
additional negotiation) to the chief patent lawyers (or their nominees) of each
party, and then, if not resolved, to the chief executive officers of each party.
If, thirty (30) days after referral to the chief executive officers, the parties
continue to have a good faith dispute as to the proper categorization of the
above-referenced materials, such materials shall be Joint Materials, provided
that such categorization shall not cause a breach of, or a right to terminate,
any ABX In-License.
E. Transfer of Materials. The transfer of physical
possession of any materials owned by, and the physical possession and use of
such materials and/or data by, MBio of 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 and/or data to MBio or ABX, as the case may be.
2.2 Supply of XenoMouse Animals and Materials; Material Transfer Terms.
All XenoMouse Animals, and all materials derived in whole or part from XenoMouse
Animals (including without limitation Products), provided by ABX to MBio are
provided solely for use in accordance with, and subject to, the following terms
and conditions:
(a) all XenoMouse Animals transferred to MBio shall be the
sole property of ABX, and the transfer of physical possession to MBio, and/or
possession or use by MBio, of XenoMouse Animals shall not be, nor be construed
as, a sale, lease, offer to sell or lease, or other transfer of title to any
XenoMouse Animals;
(b) all XenoMouse Animals and all materials derived in whole
or part from the XenoMouse Animals (including without limitation Products) shall
remain in the control of MBio and shall not be transferred to MBio's Affiliates
or Sublicensees or any other party (other than ABX), [*]
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[*]
(c) MBio shall not directly or indirectly use or attempt to
use the XenoMouse Animals, or any materials derived in whole or part from the
XenoMouse Animals (including without limitation Products) to reproduce the
XenoMouse Animals or to generate or produce by any means XenoMouse Animals or
other transgenic mice or other transgenic animals;
(d) The XenoMouse Animals shall be delivered to MBio solely
for the purpose of immunizing the XenoMouse Animals with the Antigen, and MBio
shall not use the XenoMouse Animals, or any materials derived in whole or part
from the XenoMouse Animals (including without limitation Products), for any
purpose other than (i) immunizing the XenoMouse Animals with the Antigen, and
(ii) subsequent use of such immunized XenoMouse Animals and materials derived
therefrom (including without limitation Products) as reasonably necessary for
creation, manufacture, use, identification, and commercialization of Products
pursuant to the Antigen Product License (if entered into by the parties);
(e) MBio shall not sell, have sold, lease, offer to sell or
lease, otherwise transfer title to (i) any XenoMouse Animals, (ii) cells derived
in whole or part from the XenoMouse Animals (including without limitation
hybridomas), or (iii) except as provided in (f) below, any other materials
derived in whole or part from the XenoMouse Animals (including without
limitation Products);
(f) MBio shall not sell, have sold, lease, offer to sell or
lease, otherwise transfer title to, or otherwise distribute, clinically develop,
or commercialize any Product without obtaining the Antigen Product License from
ABX with respect to such Product;
(g) MBio shall not use the XenoMouse Animals to make or use
antibodies to any antigen other than the Antigen (including without limitation
to [*];
(h) Upon expiration or termination of this Agreement for any
reason, MBio shall destroy (or return to ABX) each XenoMouse Animal and certify
such destruction as directed by ABX, within ten (10) days after such expiration
or termination, except as otherwise provided in the Antigen Product License (if
entered into by the parties);
(i) ABX shall own all right, title and interest in and to all
inventions and intellectual property (whether patentable or nonpatentable) made
or created by MBio (and any of its agents or employees) through any use of the
XenoMouse Animals (and/or materials derived in
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whole or part from the XenoMouse Animals) which is not in accordance with the
terms and conditions set forth in this Article 2;
(j) The XenoMouse Animals shall be the property of ABX, and
the transfer of physical possession of any such materials to, and the physical
possession of such materials by, MBio shall not be (nor be construed as) a sale,
lease, offer to sell or lease, or other transfer of title of such materials to
MBio;
(k) No implied licenses or rights are conveyed to MBio or ABX
hereunder. MBio shall only be authorized regarding the use of XenoMouse Animals
and the manufacture, research use, and (if permitted under the Antigen Product
License, if entered into by the parties) commercial exploitation of materials
derived in whole or part from the XenoMouse Animals (including without
limitation Products) solely as expressly provided hereunder or under the Antigen
Product License (if entered into by the parties);
(l) MBio shall only use the XenoMouse Animals and materials
derived in whole or part 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. Such materials will not be used in humans, except as
otherwise expressly set forth in the Antigen Product License (if entered into by
the parties). MBio acknowledges that the XenoMouse Animals, and all materials
derived in whole or part from the XenoMouse Animals, are experimental in nature
and may have unknown characteristics and therefore shall use prudence and
reasonable care in the use, handling, storage, transportation, disposition and
containment of such materials and all derivatives thereof;
(m) Unless otherwise agreed by ABX in advance in writing, all
XenoMouse Animals delivered to MBio shall be delivered to MBio's animal facility
in Cambridge Massachusetts, [*] 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 MBio); and
(n) XT shall be a third-party beneficiary of the commitments
by MBio set forth in items (a) through (g) above.
2.3 Research License.
(a) Subject to the terms and conditions of this Agreement, ABX
hereby grants to MBio a nonexclusive license (or sublicense, as the case may be)
under the Licensed Technology, with the limited right to grant sublicenses only
as provided under Section 2.3(b) below, (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) Antibody Cells that secrete or express 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)
Products solely for research and development of such Products for use in the
Research Field. MBio shall not use the Licensed Technology or any materials
derived in whole or in part from the XenoMouse Animals (including without
limitation Products) for any
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other purpose other than those uses expressly licensed under this Section 2.3 or
as otherwise expressly set forth in the Antigen Product License (if entered into
by the parties). The rights and (sub)license granted under this Section 2.3
shall terminate upon the earlier of (i) such time as MBio and ABX execute the
Antigen Product License and (ii) November 30, 1999.
(b) MBio shall have the right to [*]
(c) MBio shall have the right to contract with MBio Affiliates
[*] to perform certain tasks (e.g., without limitation, pathology studies) in
support of MBio's activities under this Agreement; provided, however, that (i)
such contract shall expressly exclude the use of the XenoMouse Animals; (ii)
such contract shall permit the transfer only of Antibodies, Genetic Materials
and Antibody Cells to such contractor; (iii) such contractor shall expressly
agree to be bound by the terms and conditions (including without limitation the
ownership, exclusivity, confidentiality and indemnification provisions) of this
Agreement to the extent applicable to the contracted services; and (iv) MBio
remains obligated for such contractor's performance hereunder.
2.4 Limitation. Notwithstanding any other provision of this Agreement,
in no event shall MBio (i) file, or authorize any third party to file, an IND
with respect to a Product or (ii) 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), unless and until MBio has entered into the
Antigen Product License for such Product in accordance with Section 3.5 below.
2.5 Exclusivity.
(a) During the term of this Agreement and the term of the
Antigen Product License (if entered into by the parties), MBio shall not use in
clinical trials, sell or commercialize any other antibody or fragment thereof
that binds to the Antigen, or enter into any agreement with any third party
regarding the clinical development, sale or commercialization of such antibodies
or fragments, without prior written approval of ABX. Notwithstanding the
foregoing,
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MBio shall not be precluded from (i) conducting, or collaborating or contracting
with a third party to conduct, early-stage or preclinical studies with respect
to any other antibody or fragment thereof that binds to the Antigen, or (ii)
clinically developing, selling or commercializing any antibodies or fragments
thereof whose principal binding affinity is to, and mode of action is through,
an antigen other than the Antigen, regardless of whether such antibodies or
fragments also bind to the Antigen, or from entering into any agreement with any
third party regarding the clinical development, sale or commercialization of
such antibodies or fragments.
(b) During the term of this Agreement and the term of the
Antigen Product License (if entered into by the parties), except as provided in
Section 3.2.4 below, ABX shall not (i) develop or sell any antibody or fragment
thereof that binds to the Antigen, or enter into any agreement with any third
party for the creation, research or development of such antibodies or fragments
thereof, or (ii) option, license or otherwise transfer rights of any kind
whatsoever, whether for research or commercial purposes, to any third party,
which would enable such third party to develop or sell any antibody or fragment
thereof that binds to the Antigen, without prior written approval of MBio.
Notwithstanding the foregoing, ABX shall not be precluded from clinically
developing, selling or commercializing any antibodies or fragments thereof whose
principal binding affinity is to, and mode of action is through, an antigen
other than the Antigen, regardless of whether such antibodies or fragments also
bind to the Antigen, or from entering into any agreement with any third party
regarding the clinical development, sale or commercialization of such antibodies
or fragments.
2.6 Reports. MBio agrees to keep ABX reasonably informed as to its
research activities hereunder. [*]
3. OPTION TO OBTAIN ANTIGEN PRODUCT LICENSE
3.1 Option. Subject to the terms and conditions set forth in this
Agreement, ABX hereby grants to MBio an option (the "Option") to execute, and to
have ABX execute, the Antigen Product License, which Option may be exercised by
MBio pursuant to the procedures set forth in this Article 3 on or before
November 30, 1999.
3.2 Exercise of Option.
3.2.1 Exercise. To exercise the Option, on or before the date
set forth in Section 3.1 above, MBio shall give ABX irrevocable written notice
(the "Exercise Notice") stating that MBio desires that ABX obtain the XT-ABX
Product License for the Antigen and grant to MBio the Antigen Product License.
MBio's exercise of the Option shall be effective upon receipt by ABX of the
Exercise Notice. In the event that ABX has not received the Exercise Notice on
or before the date set forth in Section 3.1 above, the Option shall immediately
terminate.
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3.2.2 Obtaining the XT-ABX Product License for the Antigen.
Following MBio's exercise of the Option, ABX shall exercise its option under the
Xenotech Agreement and shall obtain the XT-ABX Product License for the Antigen.
Upon execution of the XT-ABX Product License, MBio and ABX shall execute the
Antigen Product License, and MBio shall pay to ABX the license fee set forth in
Section 3.1 of the Antigen Product License.
3.2.3 Definition of Antigen. ABX shall establish as the
definition of the Antigen under the Xenotech Agreement the same definition of
the Antigen as is established under this Agreement (or such other definition
which does not materially lessen the rights granted to MBio under this Agreement
and under the Antigen Product License (if executed by the parties).
3.2.4 Use by ABX. If MBio does not exercise its Option on or
before the date set forth in Section 3.1 above, or if MBIO does not promptly
thereafter enter into the Antigen Product License, ABX shall be entitled, in its
sole discretion, to exercise ABX's rights under the Xenotech Agreement and enter
into the XT-ABX Product License related to the Antigen on its own behalf or on
behalf of a third party [*], and shall not be obligated to enter into the
Antigen Product License with MBio; provided, however, [*]
3.3 Execution of Antigen Product License. At such time as ABX enters
into the XT-ABX Product License with respect to the Antigen as described in
Section 3.2.2, MBio and ABX shall promptly execute the Antigen Product License.
3.4 [*]
3.4.1 Subject to Section 3.4.2, [*]. Subject to Section 3.4.2,
[*]
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[*]
3.4.2 Notwithstanding Section 3.4.1, [*]
4. INTELLECTUAL PROPERTY
4.1 Existing MBio Intellectual Property. MBio owns and shall own all
right, title and interest in and to inventions made, conceived, reduced to
practice and otherwise developed by MBio prior to the Effective Date of the RCA
and all intellectual property thereto.
4.2 Existing ABX Intellectual Property. ABX owns and shall own all
right, title and interest in and to inventions made, conceived, reduced to
practice and otherwise developed by ABX prior to the Effective Date of the RCA
and all intellectual property thereto.
4.3 MBio Intellectual Property. Except as otherwise provided in
Sections 4.4 and 4.5 below, MBio shall own all right, title and interest in and
to inventions made, conceived, reduced to practice, or otherwise developed
solely by MBio pursuant to the RCA, this Agreement or the Antigen Product
License (if entered into by the parties) and all intellectual property thereto
(the "MBio Intellectual Property").
4.4 Joint Intellectual Property. Except as otherwise provided in
Section 2.1.4 or 2.2(i) above, MBio and ABX shall jointly own all right, title
and interest in and to (a) all inventions made jointly by ABX and MBio personnel
under the RCA, this Agreement or the Antigen Product License (if entered into by
the parties), and all intellectual property thereto, and (b) all inventions,
solely or jointly made, conceived, reduced to practice, or otherwise developed
by, or under the authority of, MBio and/or ABX in the course of performing
research or development work under the RCA, this Agreement or the Antigen
Product License (if entered into by the parties) regarding the Joint Materials
and/or the Antibody Cells that contain, express, or secrete Antibodies that bind
to the Antigen or Genetic Materials that encode such Antibodies, and all
intellectual property thereto (all of the foregoing, collectively, the "Joint
Intellectual Property"). Nothing in this Section 4.4 shall convey, or be
construed to convey, title in or to the biological materials themselves
embodying any such jointly-owned inventions or intellectual property to MBio or
ABX, as the case may be.
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4.5 ABX Intellectual Property. Except as otherwise provided in Section
4.4 above, ABX shall own all right, title and interest in and to (a) all
inventions made, conceived, reduced to practice, or otherwise developed solely
by ABX pursuant to the RCA, this Agreement or the Antigen Product License (if
entered into by the parties) and all intellectual property thereto, and (b) all
inventions made, conceived, reduced to practice or otherwise developed jointly
or solely by MBio and/or ABX using XenoMouse Animals or related to ABX Materials
whether derived in whole or part from XenoMouse Animals and all intellectual
property rights thereto (all of the foregoing, collectively, the "ABX
Intellectual Property").
4.6 Determinations Regarding Intellectual Property. In the event of any
good faith dispute between the parties with respect to the proper categorization
of intellectual property under Sections 4.1 through 4.5 above, the parties shall
attempt to resolve such dispute, first by thirty (30) days' amicable
negotiations, then by referral of the dispute (for thirty (30) days' additional
negotiation) to the chief patent lawyers (or their nominees) of each party, and
then, if not resolved, to the chief executive officers of each party. If, thirty
(30) days after referral to the chief executive officers, the parties continue
to have a good faith dispute as to the proper categorization of the
above-referenced intellectual property, such intellectual property shall be
Joint Intellectual Property, provided that such categorization shall not cause a
breach of, or a right to terminate, any ABX In-License.
4.7 Assignment and Disclosure of Inventions. MBio and ABX shall cause
each employee, agent, or independent contractor that conducts research pursuant
to the RCA, this Agreement or the Antigen Product License (if entered into by
the parties) using the XenoMouse Animals, or any materials derived in whole or
part, from the XenoMouse Animals (including without limitation the Products), to
promptly disclose to ABX or MBio, as the case may be, and appropriately assign
any and all rights in and to, inventions made, conceived, reduced to practice,
or otherwise developed by, or under the authority of, MBio or ABX hereunder.
MBio and ABX agree to 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 MBio or ABX, as the
case may be, for information based upon such records.
4.8 Prosecution and Maintenance of Patents.
4.8.1 ABX. ABX shall have the sole right and responsibility
(but not the obligation), at its expense, to file, prosecute and maintain all
patent applications within (and to conduct any interferences, oppositions, or
reexaminations on, and to request any reissues or patent term extensions of):
(i) the ABX Patent Rights, other than those patent applications that claim Joint
Intellectual Property; (ii) the [*]; and (iii) the ABX Intellectual Property.
4.8.2 MBio. MBio shall have the sole right and responsibility
(but not the obligation), at its expense, to file, prosecute and maintain all
patent applications (and to conduct any interferences, oppositions, or
reexaminations thereon, and to request any reissues or patent term extensions
thereof) within the MBio Intellectual Property.
4.8.3 Joint. Except as otherwise set forth in the Antigen
Product License (if
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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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entered into by the parties), MBio shall have the first right and responsibility
(but not the obligation), at its expense, to file, prosecute and maintain all
patent applications (and to conduct any interferences, oppositions, or
reexaminations thereon, and to request any reissues or patent term extensions
thereof) within the Joint Intellectual Property. MBio shall: (i) provide ABX
with any patent application filed hereunder by MBio promptly prior to filing and
receive and incorporate reasonable comments by ABX thereon; (ii) provide ABX
with any patent application filed hereunder by MBio 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 thereon (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 MBio
upon request and at MBio's sole expense, and to the extent commercially
reasonable, in preparing, filing or maintaining the patent applications and
patents claiming Joint Intellectual Property. If MBio fails to undertake the
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 MBio
discontinues the prosecution or maintenance of a patent application or a patent,
ABX at its expense may, in its discretion, undertake such filing, prosecution or
maintenance thereof, in which case such patent application and patent thereon
shall be solely owned by ABX.
4.9 Enforcement of Patents. MBio shall use good faith efforts to
enforce the patent rights within the Joint Intellectual Property, and to consult
with ABX both prior to and during said enforcement. ABX shall reasonably
cooperate with MBio, upon request by MBio and at the sole expense of MBio, in
taking any action to enforce such patent rights. All monies recovered upon the
final judgment or settlement of any such action shall be used first to reimburse
the costs and expenses (including reasonable attorneys' fees) of MBio and ABX,
with the remainder for the account of the party or parties that undertake such
actions to the extent of their financial participation therein. To the extent
that damages are awarded for lost sales or lost profits from the sale of
Products, such damages shall be allocated among the parties taking into account
royalties that would have been payable to ABX on the sale of such Products. ABX
shall use efforts consistent with prudent business judgment to enforce the
patent rights within the ABX Patent Rights that are licensed to MBio hereunder,
or would be licensed to MBio under the XT-ABX Product License Agreement, if
entered into by the parties, and to consult with MBio both prior to and during
said enforcement. MBio shall reasonably cooperate with ABX, upon request by ABX
and at the sole expense of ABX, in taking any action to enforce such patent
rights. ABX shall be entitled to all monies recovered upon the final judgment or
settlement of any such action.
4.10 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 generated or
derived from XenoMouse Animals), except as expressly set forth herein regarding
the Antigen. Accordingly, in the event that any patent owned or controlled by
MBio that
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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, MBio
hereby grants to ABX a royalty-free, perpetual, irrevocable license, 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.
4.11 Covenant Not to Xxx. During the term of this Agreement and the
Antigen Product License (if entered into by the parties), ABX shall not enforce
against MBio or its Affiliates any issued patent which (a) is owned by ABX or
its Affiliate, or is licensed to ABX or its Affiliate with the right to enforce
(without an obligation to pay royalties or other amounts to any other Person),
(b) covers XenoMouse Animals, and (c) would be infringed by the conduct of
research and development in the Research Field, or by the manufacture, use or
sale of Products in the Field, to the extent permitted under this Agreement or
the Antigen Product License (if entered into by the parties).
5. CONFIDENTIALITY
5.1 Confidentiality. For purposes of this Agreement, (i) the ABX
Materials and all written and oral communications related thereto are and shall
remain the Confidential Information of ABX, (ii) the MBio Materials and all
written and oral communications related thereto are and shall remain the
Confidential Information of MBio, and (iii) the Joint Materials and all written
and oral communications related thereto are and shall remain the joint
Confidential Information of ABX and MBio. Except as expressly provided herein,
MBio 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, whether or not furnished to it by the other party
pursuant to this Agreement (including, without limitation, know-how) until the
later of (i) ten (10) years from the Effective Date or (ii) five (5) years
following the expiration or termination of this Agreement.
5.2 Disclosure to Third Parties. Notwithstanding Section 5.1 above,
each party may disclose Confidential Information regarding the Joint Materials
and Joint Intellectual Property to permitted sublicensees and contractors
hereunder, provided that such sublicensee or contractor agrees in writing to be
bound the confidentiality and non-use obligations of this Agreement.
5.3 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 required by law 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). It is understood that the expiration of MBio's obligations under
Section 5.1 above shall not be deemed to limit MBio's obligations under Section
2.2 above.
5.4 Terms of Agreement. Neither party shall disclose any terms or
conditions of this
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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 Affiliates including, but not
limited to, for MBio, Millennium Pharmaceuticals, Inc., Millennium Information,
Inc., Millennium Predictive Medicine, Inc., plus any future Affiliates that own
a majority of the stock of MBio or that MBio owns a majority of the stock
thereof (and any affiliated companies that own a majority of the stock of
Millennium Pharmaceuticals, Inc. or that Millennium Pharmaceuticals, Inc. owns a
majority of the stock thereof), and for ABX, Xenotech L.P. plus any future
Affiliates that own a majority of the stock of ABX or that ABX owns a majority
of the stock thereof) and to its/their 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 MBio 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 MBio from time to time,
without the consent of the other.
6. INDEMNIFICATION
6.1 MBio. MBio 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 MBio under this Agreement, (ii) the
performance of the Research by MBio, (iii) any use, handling or storage by MBio
of the ABX Materials, the Joint Materials, or Products, or (iv) any use by MBio
of the Confidential Information of ABX; provided, however, that MBio shall not
be obligated to indemnify or hold harmless ABX for such Liabilities to the
extent that such Liabilities arise from (a) the gross negligence or willful
misconduct of ABX, or (b) the misappropriation by ABX of the trade secrets or
other proprietary information of a Third Party.
6.2 ABX. ABX shall indemnify and hold harmless MBio, 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
MBio; provided, however, that ABX shall not be obligated to indemnify or hold
harmless MBio for such Liabilities to the extent that such Liabilities arise
from (a) the gross negligence or willful misconduct of MBio, or (b) the
misappropriation by MBio of the trade secrets or other proprietary information
of a Third Party.
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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 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.
7.1.1 ABX represents and warrants that: (i) it has the full
right, power and authority to enter into this Agreement and to grant the rights
and licenses hereunder; (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.
7.1.2 ABX further represents and warrants that:
(i) on or before the Effective Date, it has provided to MBio
complete copies of all applicable ABX In-Licenses (including without limitation
the GenPharm Cross License Agreement) setting forth all applicable rights,
limitations and restrictions described in Section 9.9 below (it being understood
that the financial terms have been redacted from some or all such copies);
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(ii) based upon information provided to ABX by MBio concerning
MBio's intellectual property rights in the Antigen, and to the best of ABX's
knowledge (without the obligation to perform due diligence), (a) ABX has the
right to obtain from XT an XT-ABX Product License with respect to the Antigen
that is an "Exclusive Worldwide Product License" (as defined in the Xenotech
Agreement and in the form attached thereto as an exhibit); (b) the license or
sublicense to be granted to ABX pursuant to such XT-ABX Product License with
respect to the Antigen shall be exclusive even as to XT; and (c) JTI does not
have the right under the Xenotech Agreement to obtain an "Exclusive Home
Territory Product License" or a "Co-Exclusive Worldwide Product License" (as
these are defined in the Xenotech Agreement and attached thereto as exhibits)
with respect to the Antigen, or any other right or license under the Licensed
Technology to develop, make and have made, use, sell, lease, offer to sell or
lease, import, export, otherwise transfer physical possession of or otherwise
transfer title to Products for use in the Field; except, in each case, with
respect to the research license set forth in Article 3 of the Xenotech
Agreement;
(iii) ABX has nominated the Antigen under [*] the
Xenotech Agreement as required under the Xenotech Agreement to obtain the right
to acquire an "Exclusive World Wide Product License" under the Xenotech
Agreement with respect to the Antigen; and
(iv) the XT-ABX Product License to be executed by XT and ABX
will be substantially identical (i.e., other than with respect to the effective
date thereof and the definition of the antigen under such agreement) to the form
agreement attached to this Agreement as Exhibit D (it being understood that the
financial terms may be redacted from such form agreement).
7.1.3 Upon execution of the XT-ABX Product License with
respect to the Antigen, ABX shall provide MBio with a copy of such
fully-executed XT-ABX Product License (it being understood that the financial
terms may be redacted from such copy). At any time during the term of this
Agreement or the Antigen Product License (if entered into by the parties) at the
request of MBio, ABX shall discuss with MBio ABX's interpretation of material
terms and conditions of the applicable ABX In-Licenses, including, without
limitation, the form of agreement attached to this Agreement as Exhibit D, the
XT-ABX Product License, and any limitations on ABX's right to further transfer
or grant licenses or sublicenses to MBio to any and all rights to technology
within the scope of the ABX Patent Rights and/or ABX Know-How under any ABX
In-License.
7.2 MBio. MBio represents and warrants that: (i) it has the full right,
power and authority to enter into this Agreement; (ii) to the knowledge of MBio,
there are no existing or threatened actions, suits or claims pending with
respect to the subject matter hereof or the right of MBio 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 fail to
take any action, under this Agreement or the Antigen Product License, if entered
into by the parties, that will cause a breach of the GenPharm Cross License
Agreement, the
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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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Xenotech Agreement or the XT-ABX Product License.
7.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, ABX AND MBIO MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY
KIND REGARDING ABX MATERIALS, MBIO MATERIALS, JOINT 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 MATERIALS DERIVED IN WHOLE OR PART FROM XENOMOUSE
ANIMALS PROVIDED TO MBIO PURSUANT TO THIS AGREEMENT ARE PROVIDED "AS IS," AND
ABX SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH RESPECT TO SUCH XENOMOUSE
ANIMALS AND MATERIALS DERIVED IN WHOLE OR PART FROM XENOMOUSE ANIMALS.
8. TERM; TERMINATION
8.1 Term. This Agreement shall commence on the Effective Date and,
unless earlier terminated pursuant to the other provisions of this Article 8,
shall continue in effect until December 31, 1999.
8.2 Termination by MBio. MBio may terminate this Agreement at any time
upon ninety (90) days written notice to ABX.
8.3 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-day period unless the
breaching party has cured any such breach or default prior to the expiration of
the thirty-day period.
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. It is agreed that no waiver by a party hereto of any breach
or default of any
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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 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 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, except as otherwise provided under Section
2.2(b) above, ABX shall not be obligated without its consent to send XenoMouse
Animals to any party other than MBio, nor shall MBio 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 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.
Millennium BioTherapeutics, Inc.:
Millennium BioTherapeutics, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telecopier: 000-000-0000
Attn: General Manager
Abgenix, Inc.:
Abgenix, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attn: President
with a copy to:
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Pillsbury Madison & Sutro LLP
000 Xxxx Xxxxxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxx
9.7 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.
9.8 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 9.8 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY.
9.9 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 MBio hereunder,
including without limitation any grant of "exclusive" rights, shall be subject
to the rights granted to or retained by GenPharm under the GenPharm Cross
License Agreement.
9.10 Complete Agreement. It is understood and agreed by the parties
that this Agreement constitutes the entire agreement, both written and oral,
among the parties with respect to the subject matter hereof, and that all prior
agreements respecting 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 RCA. No amendment or change hereof
or addition hereto shall be effective or binding on the parties hereto unless
reduced to writing and executed by the respective duly authorized
representatives of the parties.
9.11 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.
9.12 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, each copy of which shall for all purposes be deemed to be
an original.
ABGENIX, INC. MILLENNIUM BIOTHERAPEUTICS, INC.
By: /s/ R. Xxxxx Xxxxx By: /s/ Xxxx Xxxxxxxxxx
------------------------------ -------------------------------------
Printed Name: R. Xxxxx Xxxxx Printed Name: Xxxx Xxxxxxxxxx
-------------------- ---------------------------
Title: Presdent & CEO Title: VP & General Manager
--------------------------- ----------------------------------
Date: 11/6/98 Date: 11/6/98
---------------------------- ----------------------------------
MILLENNIUM PHARMACEUTICALS, INC. hereby acknowledges and
agrees to be bound by the terms and conditions of this
Agreement to the extent applicable to the facilities used
and services performed pursuant to Section 2.2(b) above.
MILLENNIUM PHARMACEUTICALS, INC.
By: /s/ Xxxx X. Xxxx
--------------------------------------
Printed Name: Xxxx X. Xxxx
----------------------------
Title: Assoc. General Counsel
Corporate and Transactions
-----------------------------------
Date: 11/6/98
-------------------------------------
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EXHIBIT A
FORM OF PRODUCT LICENSE AGREEMENT
THIS PRODUCT LICENSE AGREEMENT (the "Agreement") effective the ____ day
of ________, ____ (the "Effective Date"), is made by and between ABGENIX, INC.,
a Delaware corporation ("ABX"), and MILLENNIUM BIOTHERAPEUTICS, INC. a Delaware
corporation ("MBio").
RECITALS
MBio and ABX have entered into the Research License and Option
Agreement (as defined below), pursuant to which MBio has certain rights to
acquire a license under the Licensed Technology (as defined below); and MBio has
exercised its 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 in this
Agreement, that not defined below in this Article 1, shall have the meaning as
set forth in the Research License and Option Agreement.
1.1 "Affiliate" shall mean any entity which controls, is controlled by
or is under common control with ABX, MBio or a Sublicensee. An entity shall be
regarded as in control of another entity if it owns or controls at least fifty
percent (50%) of the shares 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).
1.2 "Antibody" shall mean a composition comprising a whole antibody or
fragment thereof, said antibody or fragment having been derived in whole or part
from the XenoMouse Animals provided by ABX to MBio pursuant to the RCA or the
Research License and Option Agreement, or having been derived from nucleotide
sequences encoding, or amino acid sequences of, such an antibody or fragment.
1.3 "Confidential Information" shall mean, with respect to a party, all
information of any kind whatsoever (including without limitation, compilations,
data, formulae, models, patent
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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 and is disclosed by such
party to the receiving party and is marked, identified as or otherwise
acknowledged to be confidential at the time of disclosure to the receiving
party. 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 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.
1.4 "Core Third Party Patents" shall mean an issued, unexpired patent
that is owned or controlled by a third party (other than ABX, MBio, a
Sublicensee, or an Affiliate of either MBio or its Sublicensee) and is not
licensed to ABX, MBio, a Sublicensee, or Affiliates of ABX or MBio, that has not
been invalidated in a final unappealed or unappealable judgment by a court of
competent jurisdiction, which patent covers XenoMouse Animals and which patent
would be infringed by the sale of Products but for ABX or MBio, as the case may
be, obtaining a royalty-bearing license under such patent (other than pursuant
to this Agreement) in order to commercialize Products in the Field under this
Agreement.
1.5 "Field" shall mean the use of Products for human therapeutic,
preventative (prophylactic) and diagnostic medical purposes.
1.6 "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.
1.7 "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.
1.8 "IND" shall mean an Investigational New Drug application filed with
FDA, or
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any similar filing with any foreign regulatory authority, to commence human
clinical testing of any Product in any country in the Territory.
1.9 "JTI" shall mean Japan Tobacco Inc., a Japanese corporation
1.10 "Licensed Technology" shall mean ABX Patent Rights, ABX Know-How
and [*]; provided, however, that Licensed Technology shall not include Excluded
Technology.
1.10.1 "ABX Patent Rights" shall mean (i) the patents and
patent applications listed on Attachment A hereto and any foreign counterparts
thereto; (ii) the patent applications which claim Joint Intellectual Property as
defined in Section 4.4 of the Research License and Option Agreement; (iii) 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 (iv) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patents and patent applications.
1.10.2 "ABX Know-How" shall mean information discovered,
developed or acquired by ABX prior to the Effective Date of the Research License
and Option Agreement regarding methods and techniques of immunizing the
XenoMouse Animals to the Product Antigen which is disclosed by ABX to MBio
pursuant to the RCA, the Research License and Option Agreement or this
Agreement. All ABX Know-How shall be treated as "Confidential Information" of
ABX under Article 7 of this Agreement.
1.10.3 "ABX In-License" shall mean a license, sublicense or
other agreement under which ABX acquired rights to the ABX Patent Rights or the
ABX Know-How.
1.10.4 [*]
1.10.5 "Excluded Technology" shall mean any intellectual
property or technology of ABX in or to (i) all antigens other than the Product
Antigen, including without limitation: (A) compositions of such antigens or of
Genetic Materials encoding such antigens; (B) uses of such antigens; (C)
antibodies or other compositions that bind to such antigens, Genetic Materials
encoding such antibodies or compositions, and cells that contain, express, or
secrete such antibodies, genetic materials, or compositions; and (D) uses of
such antibodies, Genetic Materials, or compositions; (ii) methods to discover
novel antigens; (iii) methods of using antigens other than to create antibodies;
and (iv) the ABX Intellectual Property.
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1.11 "Net Sales" shall mean [*]
1.11.1 "MBio Net Sales" shall mean the Net Sales of MBio and
its Affiliates.
1.11.2 "Sublicensee Net Sales" shall mean the Net Sales of
Sublicensees.
1.12 "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.
1.13 "Product" shall mean any product comprising (i) an Antibody that
binds to the Product Antigen or (ii) Genetic Material encoding such an Antibody
wherein, in respect of each Product, said Genetic Material does not encode
multiple antibodies.
1.14 "Product Antigen" shall mean [*]. As used in this Agreement,
[*]
1.15 "RCA" shall mean that certain Research Collaboration Agreement
between MBio and ABX effective as of July 15, 1998.
1.16 "Research License and Option Agreement" shall mean that certain
Research License and Option Agreement entered into by and between ABX and MBio
effective as of October 30, 1998, as the same may be amended from time to time.
1.17 "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.
1.18 "Territory" shall mean all the countries of the world.
1.19 "XenoMouse" and "XenoMouse Animals" shall mean one or more
transgenic
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mice provided by ABX to MBio for immunization with the Product Antigen under the
RCA or the Research License and Option Agreement.
1.20 "Xenotech Agreement" shall mean that certain Master Research
License and Option Agreement entered into by 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.
1.21 "XT" shall mean Xenotech, L.P., a California limited partnership.
1.22 "XT-ABX Product License" shall mean a license granted from XT to
ABX pursuant to the terms of the Xenotech Agreement permitting ABX to
commercialize certain products in one or more territories.
2. LICENSE GRANT
2.1 Grant of Rights. Subject to the terms and conditions of this
Agreement, ABX hereby grants to MBio 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 and for no other purpose.
2.2 Sublicenses. MBio may grant a Sublicense under Section 2.1 to an
Affiliate or other third party; provided, however, that (i) any such Sublicense
shall be subject and subordinate to the terms and conditions of this Agreement;
(ii) any such Sublicensee shall agree in writing to be bound by the terms and
conditions of this Agreement; (iii) MBio shall remain responsible for any such
Sublicensee's performance hereunder and for all payments due to ABX hereunder
with respect to Net Sales of Products by any such Sublicensee; and (iv) MBio
shall provide ABX with a copy of each such sublicense agreement promptly after
execution of the same (provided that the financial terms may be redacted
therefrom). Notwithstanding the foregoing, MBio shall in no event 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 MBio hereunder, and no additional rights shall be
deemed granted to MBio by implication, estoppel or otherwise. Without limiting
the foregoing, the rights of MBio under this Agreement are subject and
subordinate in all respects to the provisions of Section 2.2 of the Research
License and Option Agreement.
3. CONSIDERATION.
3.1 License Fee. Within fifteen (15) days after the Effective Date,
MBio shall pay to ABX [*]
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3.2 Milestone Payments.
3.2.1 Amounts. Within thirty (30) days following the first
achievement by MBio (or any of its Affiliates or Sublicensees) of each the
following milestones with respect to each Product licensed under this Agreement,
on a Product-by-Product basis, MBio shall pay to ABX [*]
Milestone Payment
--------- -------
A [*]
B [*]
C [*]
D [*]
3.2.2 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.
3.3 Royalties. MBio 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 MBio, 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").
3.3.1 MBio Net Sales. In consideration of the license
granted herein, MBio shall pay to ABX a royalty on MBio Net Sales as follows:
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[*]
3.3.2 Sublicensee Net Sales. In consideration of the license
granted herein, MBio shall pay to ABX a royalty on Sublicensee Net Sales equal
to [*]
Notwithstanding anything to the contrary in this Agreement (other than as
provided in Section 3.6.3 below), the royalty amount payable to ABX under this
Section 3.3.2 with respect to Sublicensee Net Sales for any Product in any
country shall [*] of Sublicensee Net Sales of such Product in such country;
provided, further, that if the royalty increase pursuant of Section 3.3.3 also
applies, the royalty amount payable to ABX under this Section 3.3.2 with respect
to Sublicensee Net Sales for such Product in such country shall [*]
3.3.3 Use of [*]. The applicable royalty rates set forth in
Sections 3.3.1 and 3.3.2 above for sales of a Product in a given country shall
be [*] of Net Sales of such Product if (a) there is a Patent Claim within the
[*] in the country where such Products are made or sold and which would be
infringed by making or selling such Product in such country, or (b) the Product
utilizes or is based on, derived from, or produced using, [*] or any know-how
thereof.
3.3.4 Length of Term of Royalty Obligations. MBio'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 as defined in Section 3.3 above, and continue
thereafter for such Product on a country-by-country basis until the later of
[*]
3.3.5 Royalty Payable Only Once. The obligation to pay
royalties shall be imposed only once with respect to the same unit of Product
sold by MBio, its Affiliates or
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Sublicensee; provided, however, if a unit of Product is sold by MBio or its
Affiliates to a Sublicensee for resale, then the royalty shall be imposed on the
resale of such unit of Product by such Sublicensee.
3.3.6 Third Party Royalty Offset.
(a) In the event that MBio believes, in its reasonable and
good faith belief, that in order for it to be able to manufacture and sell a
Product hereunder in a commercially feasible manner it must utilize technology
that is covered by a "Recombinant Expression Patent," and MBio does so utilize
such technology and does enter in to a license agreement under such Recombinant
Expression Patent with a non-Affiliate third party, and is obligated to pay a
running royalty thereunder in accordance with the sale of such Product under
such license, MBio may offset [*] of any running royalty payments made by MBio
to such third party on sales of such Product in a particular county, against the
royalty amounts due to ABX under this Section 3.3 on Net Sales of such Product
in such county; provided, however, that the royalty amount payable to ABX under
this Section 3.3 with respect to such Net Sales for such Product in such country
shall not be reduced pursuant to this Section 3.3.3 to an amount below [*] of
Net Sales of such Product.
(b) For purposes of this Section 3.3.6, such "Recombinant
Expression Patent" shall mean an issued, unexpired patent that is owned or
controlled by a third party (other than ABX, a Sublicensee, or an Affiliate of
either MBio or its Sublicensee) that has not been invalidated in a final
unappealed or unappealable judgment by a court of competent jurisdiction, which
patent covers the expression of Antibodies from recombinant cell lines in which
a recombinant Antibody Cell that produces Product is generated through the
cointroduction into a cell of Genetic Materials encoding heavy chain
immunoglobulin genes and light chain immunoglobulin genes and which patent would
be infringed by the sale of Products but for MBio's obtaining a royalty-bearing
license under such patent (other than pursuant to this Agreement) in order to
commercialize Products in the Field under this Agreement.
3.4 Discounting. If MBio or its Affiliate or Sublicensee sells any
Product to a third party who also purchases other products or services from
MBio, its Affiliate or Sublicensee, MBio agrees not to, and requires its
Affiliate and Sublicensee not to, discount the sales price of the Products to a
greater degree than MBio, its Affiliate or Sublicensee, respectively, generally
discounts the price of its other products to such customer.
3.5 Royalties To Be Paid By ABX. It is understood that, subject to the
terms and conditions of this Agreement, including without limitation MBio'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 C in respect of Net
Sales of Products in accordance with this Agreement, and that MBio may not
offset such payments under Section 3.3.3.
3.6 Core Third Party Patents.
3.6.1 Procedure. If either party becomes aware of any Core
Third Party Patent during the term of this Agreement, or any pending patent
application that would be a Core
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Third Party Patent if issued, such party shall promptly notify the other party
and, except to the extent that such party is prohibited under a duty of
confidentiality from disclosing such information, provide a reasonably detailed
summary of its knowledge regarding such patent or patent application (including,
by way of example and without limitation, the identity of the person that owns
or controls such patent, the subject matter of the patent or application, and
any available information about terms offered or asked with respect to licenses
under such patents). ABX shall have the first right to negotiate with any third
party for a license under any Core Third Party Patent; provided, however, that
neither ABX nor MBio (nor its Sublicensees) shall be obligated to negotiate for,
or obtain, such a license; provided, further, that if ABX elects not to
negotiate for such a license it shall promptly notify MBio of such election, and
MBio shall thereafter be free to negotiate such a license on its own behalf.
3.6.2 Royalty Payments. If ABX enters into a license under
any Core Third Party Patent, such patent shall be sublicensed to MBio hereunder
if, and only to the extent, MBio elects to take a Sublicense to such patent
under the terms negotiated by ABX; provided, however, subject to Section 3.6.3
below, MBio shall pay to ABX the royalties (if any) owed by ABX under such Core
Third Party Patent for the Net Sales of Products in the Territory by MBio and
its Sublicensees in addition to any other royalties payable to ABX under Section
3.3. The parties hereto agree to discuss and negotiate in good faith regarding
the manner in which the licensing fees, milestones, and up-front payments (if
any) owed by ABX under such license may be shared between the parties hereto.
3.6.3 Royalty Offset. MBio may offset [*] of any royalty
payments made by MBio pursuant to Section 3.6.2 above, either to ABX or to a
third party in consideration for a license under any Core Third Party Patent on
sales of a particular Product in a particular county, against the other royalty
amounts due to ABX under Section 3.3 on Net Sales of such Product in such
county; provided, however, that the royalty amount payable to ABX under Section
3.3 with respect to such Net Sales for such Product in such country shall not be
reduced pursuant to this Section 3.6.3 to an amount below [*] of Net Sales of
such Product in such country; provided, further, that if the royalty increase
pursuant of Section 3.3.3 also applies, the royalty amount payable to ABX under
this Section 3.3 with respect to such Net Sales for such Product in such country
shall not be reduced pursuant to this Section 3.6.3 to an amount below [*] of
Net Sales of such Product in such country. Any deduction hereunder, or portion
thereof, that is rendered not usable pursuant to deduction limitations set forth
above may be carried forward for use in a future royalty payment period, which
deduction carry-forwards shall not result in royalty payments lower than the
foregoing minimum royalty payments.
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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 MBio under Article
3 above, MBio agrees to make [*] written reports to ABX within [*] after the end
of each [*], stating in each such report [*]. These reports may be combined with
reports due under Section 5.4. Concurrently with the making of such reports,
MBio 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. MBio 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 MBio 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 MBio 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. MBio
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 MBio 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 MBio 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 error producing an increase exceeding [*] 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 MBio.
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 designated 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 MBio 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, [*], 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.
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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. [*]
5.2 Filing of IND. Without limiting Section 5.1 above, MBio, its
Affiliate or Sublicensee shall file an IND with the U.S. FDA for one or more
Products under this Agreement [*]; provided, however, if MBio, its Affiliate or
Sublicensee has failed to file an IND with the U.S. FDA for one or more Products
under this Agreement [*], such failure shall not constitute a material breach
under Section 10.2 below if, and (except as provided below) for so long as,
MBio, its Affiliate or Sublicensee then uses and thereafter continues to use its
best efforts to file an IND with the U.S. FDA for one or more Products under
this Agreement [*]; provided, further, in any event, MBio, its Affiliate or
Sublicensee shall file an IND with the U.S. FDA for one or more Products under
this Agreement [*] of the date of the XT-ABX Product License regarding the
Product Antigen. After the filing of an IND for a Product, MBio, its Affiliate
or Sublicensee shall be required to have an active IND and to be actively and
diligently conducting clinical trials in pursuit of regulatory approval 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 MBio (or its
Sublicensees), ABX shall have the right to terminate this Agreement pursuant to
Section 9.2 below; provided, however, with respect to a default under Section
5.1 or 5.2 above, the notice and cure period under Section 9.2 below shall be
extended from thirty (30) to ninety (90) days.
5.4 Research and Development Reports. MBio agrees to keep ABX
reasonably informed as to the research, development and commercialization of
Products hereunder. [*]
5.5 No Conflicts.
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5.5.1 Other Products. During the term of this Agreement,
MBio shall not directly or indirectly sell or commercialize for human medical
use, or conduct human clinical development toward the human medical use of any
product (other than the Products licensed hereunder), incorporating (i) an
antibody, antibody fragment or amino acid sequence derived from an antibody, in
each case which binds to the Product Antigen or (ii) Genetic Material encoding
such any such composition.
5.5.2 Discounting. In the event that MBio or its Affiliates
sells Product to a third party who also purchases other products or services
from MBio or its Affiliate, and MBio or its Affiliates discounts the purchase
price of the Product to a greater degree than MBio 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 MBio 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. MBio'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 MBio 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 [*]
6. INTELLECTUAL PROPERTY.
6.1 Prosecution. 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
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and patent applications worldwide within the Licensed Technology and conducting
any interferences, oppositions, reexaminations, or requesting reissues or patent
term extensions with respect to the Licensed Technology.
6.2 Joint Intellectual Property. Notwithstanding anything to the
contrary in this Article 6, MBio shall have the sole right and responsibility
(but not the obligation), at its expense, to file, prosecute, maintain and
enforce all patent applications (and to conduct any interferences, oppositions,
or reexaminations thereon, and to request any reissues or patent term extensions
thereof) that claim the Joint Intellectual Property (as defined in Section 4.4
of the Research License and Option Agreement) in accordance with 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 MBio
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 Product Antigen and is
competitive with Products hereunder (an "Infringement") MBio shall promptly
notify ABX. As between MBio, 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 MBio 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
MBio. Notwithstanding the foregoing, if ABX notifies MBio 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 Claim MBio may at its expense bring
or defend 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) MBio 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 MBio shall be
used first to reimburse MBio 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 MBio 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
MBio.
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 MBio (or its Affiliates or
Sublicensees), MBio shall promptly notify ABX thereof in writing setting forth
the facts of such claim in reasonable detail. MBio shall keep
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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, MBio shall not admit the invalidity of any patent
within the Licensed Technology without written consent from ABX.
6.5 Patent Marking. MBio 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 MBio 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, MBio 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, whether or not furnished to it by the other party pursuant to this
Agreement (including, without limitation, know-how) until the later of (i) ten
(10) years from the Effective Date or (ii) 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 required by law 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). It is understood that the expiration of MBio's obligations under
Section 7.1 above shall not be deemed to limit MBio's obligations under Section
2.2 of the Research License and 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 Affiliates
including, but not limited to, for MBio, Millennium Pharmaceuticals, Inc.,
Millennium Information, Inc., Millennium Predictive Medicine, Inc., plus any
future Affiliates that own a majority of the stock of MBio or that MBio owns a
majority of the stock thereof (and
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any affiliated companies that own a majority of the stock of Millennium
Pharmaceuticals, Inc. or that Millennium Pharmaceuticals, Inc. owns a majority
of the stock thereof), and for Abgenix, Xenotech L.P. plus any future Affiliates
that own a majority of the stock of Abgenix or that Abgenix owns a majority of
the stock thereof) and to its/their 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
Abgenix and MBio 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 MBio from time to
time, without the consent of the other.
8. INDEMNIFICATION
8.1 MBio. MBio 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 MBio under this Agreement, (ii) the
manufacture, use, sale, handling or storage by MBio, its Affiliates or
Sublicensees of the Products (without regard to the foregoing entities' culpable
conduct), or (iii) any use by MBio, its Affiliates or Sublicensees of the
Confidential Information of ABX; provided, however, that MBio shall not be
obligated to indemnify or hold harmless ABX for such Liabilities to the extent
that such Liabilities arise from (a) the gross negligence or willful misconduct
of ABX, or (b) the misappropriation by ABX of the trade secrets or other
proprietary information of a Third Party.
8.2 ABX. ABX shall indemnify and hold harmless MBio, 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
MBio; provided, however, that ABX shall not be obligated to indemnify or hold
harmless MBio for such Liabilities to the extent that such Liabilities arise
from (a) the gross negligence or willful misconduct of MBio, or (b) the
misappropriation by MBio of the trade secrets or other proprietary information
of a Third Party.
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
Indemnitor so desires, to assume the defense thereof with counsel mutually
satisfactory to the
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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. MBio shall secure and maintain (a) general liability
insurance at all times during the term of this Agreement, and (b) product
liability insurance at all times commencing upon the initiation of any human
clinical trials of Products by MBio, its Affiliate or Sublicensee, in each case
with respect to the development, manufacture and sales of Products in such
amount as MBio 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 MBio product liability insurance policies. MBio shall
maintain such insurance for so long as it continues to develop, manufacture or
sell any Products, and thereafter for so long as MBio customarily maintains
insurance for itself covering the development, manufacture and sale of its other
products.
9. REPRESENTATIONS AND WARRANTIES.
9.1 ABX.
9.1.1 ABX represents and warrants that: (i) it has the full
right, power and authority to enter into this Agreement and to grant the rights
and licenses hereunder; (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.
9.1.2 ABX further represents and warrants that:
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(i) on or before the Effective Date, it has provided to MBio
complete copies of all applicable ABX In-Licenses (including without limitation
the GenPharm Cross License Agreement) setting forth all applicable rights,
limitations and restrictions described in Section 10.10 below (it being
understood that the financial terms have been redacted from some or all such
copies);
(ii) based upon information provided to ABX by MBio
concerning MBio's intellectual property rights in the Antigen, and to the best
of ABX's knowledge (without the obligation to perform due diligence), (a) ABX
has obtained from XT an XT-ABX Product License with respect to the Antigen that
is an "Exclusive Worldwide Product License" (as defined in the Xenotech
Agreement and in the form attached thereto as an exhibit); (b) the license or
sublicense granted to ABX pursuant to such XT-ABX Product License with respect
to the Antigen shall be exclusive even as to XT; and (c) JTI does not have the
right under the Xenotech Agreement to obtain an "Exclusive Home Territory
Product License" or a "Co-Exclusive Worldwide Product License" (as these are
defined in the Xenotech Agreement and attached thereto as exhibits) with respect
to the Antigen, or any other right or license under the Licensed Technology to
develop, make and have made, use, sell, lease, offer to sell or lease, import,
export, otherwise transfer physical possession of or otherwise transfer title to
Products for use in the Field; except, in each case, with respect to the
research license set forth in Article 3 of the Xenotech Agreement;
(iii) ABX has nominated the Antigen under [*] the
Xenotech Agreement and taken all other actions as required under the Xenotech
Agreement to obtain an "Exclusive World Wide Product License" under the Xenotech
Agreement with respect to the Antigen; and
(iv) the XT-ABX Product License which has been executed by
XT and ABX is substantially identical (i.e., other than with respect to the
effective date thereof and the definition of the antigen under such agreement)
to the form agreement attached to the Research License and Option Agreement as
Exhibit D (it being understood that the financial terms may be redacted from
such form agreement).
9.1.3 ABX has provided MBio with a copy of such
fully-executed XT-ABX Product License (it being understood that the financial
terms may have been redacted from such copy). At any time during the term of
this Agreement at the request of MBio, ABX shall discuss with MBio ABX's
interpretation of material terms and conditions of the applicable ABX
In-Licenses, including, without limitation, the XT-ABX Product License and any
limitations on ABX's right to further transfer or grant licenses or sublicenses
to MBio to any and all rights to technology within the scope of the ABX Patent
Rights and/or ABX Know-How under any ABX In-License.
9.2 MBio. MBio represents and warrants that: (i) it has the full right,
power and authority to enter into this Agreement; (ii) to the knowledge of MBio,
there are no existing or threatened actions, suits or claims pending with
respect to the subject matter hereof or the right of MBio 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
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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 fail to
take any action, under this Agreement that will cause a breach of the GenPharm
Cross License Agreement, the Xenotech Agreement or the Product License.
9.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY 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
MATERIALS DERIVED IN WHOLE OR PART FROM XENOMOUSE ANIMALS PROVIDED TO MBio
PURSUANT TO THIS AGREEMENT ARE PROVIDED "AS IS," AND ABX SPECIFICALLY DISCLAIMS
ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT WITH RESPECT TO SUCH XENOMOUSE ANIMALS AND MATERIALS DERIVED IN
WHOLE OR PART FROM XENOMOUSE ANIMALS.
9.4 Effect of Representations and Warranties. It is understood that if
the representations and warranties under this Article 9 are not true and
accurate and a party incurs liabilities, costs or other expenses as a result of
such falsity, the party at fault shall indemnify, defend and hold the injured
party harmless from and against any such liabilities, costs or expenses
incurred, provided that the party at fault receives prompt notice of any claim
against the injured party resulting from or related to such falsity and the sole
right to control the defense or settlement thereof.
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, MBio 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 non-breaching party shall have
the right at
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its option to terminate this Agreement effective at the end of such thirty-day
period unless the breaching party has cured any such breach or default prior to
the expiration of the thirty-day period.
10.3 Termination by MBio. MBio may terminate this Agreement and the
license granted herein at any time, by providing ABX ninety (90) days written
notice.
10.4 Termination for Insolvency. Either party may terminate this
Agreement if the other becomes the subject of a voluntary or involuntary
petition in bankruptcy or any proceeding relating to insolvency, receivership,
liquidation, or dissolution, and such petition or proceeding is not dismissed
with prejudice within sixty (60) days after filing.
10.5 Effect of Termination.
10.5.1 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.
10.5.2 Stock in Hand; Sublicenses. In the event this
Agreement is terminated for any reason, MBio 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 MBio 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.
10.5.3 Research License and Option Agreement. This Agreement
is independent of, and shall not be affected by, the expiration or termination
of the Research License and Option Agreement; provided that notwithstanding the
foregoing, any breach by MBio of the surviving provisions of the Research
License and Option Agreement shall be a breach of this Agreement.
10.5.4 Survival. 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. It is agreed that 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
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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 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 (i) to any Affiliate of such
party, or (ii) 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.
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.
Millennium Biotherapeutics, Inc.:
Millennium Biotherapeutics, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telecopier: 000-000-0000
Attn: General Manager
Abgenix, Inc.:
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
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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 MBio 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. MBio
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 MBio and provide reasonable assistance to MBio as
may be reasonably necessary to obtain any required approvals.
11.9 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 MBio hereunder,
including without limitation any grant of "exclusive" rights, shall be subject
to the rights granted to or retained by GenPharm under the GenPharm Cross
License Agreement.
11.10 Force Majeure. Nonperformance of any 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.
11.11 Complete Agreement. It is understood and agreed between ABX and
MBio that this Agreement constitutes the entire agreement, both written and
oral, between the parties with respect to the subject matter hereof, and that
all prior agreements respecting the subject matter hereof, either written or
oral, expressed or implied, shall be abrogated, canceled, and are null and void
and of no effect. 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 MBio.
11.12 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.
11.13 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 executed this Agreement, through
their respective officers hereunto duly authorized, as of the day and year first
above written.
ABGENIX, INC. MILLENNIUM BIOTHERAPEUTICS, INC.
By: ____________________________ By: _____________________________
Printed Name: __________________ Printed Name: ___________________
Title: _________________________ Title: __________________________
Date: __________________________ Date: ___________________________
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ATTACHMENT A
ABX PATENT RIGHTS
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ATTACHMENT B
ABX EXPRESSION TECHNOLOGY
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ATTACHMENT C
ABX IN-LICENSES
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EXHIBIT B
I. PURSUANT TO THE MRLOA
A. Any (i) of the patent applications listed in the following Table:
[*]
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49
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 [*]
[*]
II. PURSUANT TO THE GENPHARM CROSS LICENSE
A. [*] (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
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the omitted portions.
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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 dated [*]
[*]
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EXHIBIT C
[*]
Any (i) of the patents or patent applications listed in the following
Table:
[*]
(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 patents issuing
thereon, and (iv) any foreign counterparts issued or issuing on any of (i),
(ii), or (iii) above.
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EXHIBIT D FORM OF ABX-XT PRODUCT LICENSE
THIS PRODUCT LICENSE AGREEMENT (the "Agreement") effective the ____ day
of ____________, _____, is made by and between XENOTECH, L.P., a California
limited partnership ("XT"), and ABGENIX, INC., a Delaware corporation ("ABX")
("Licensee").
RECITALS
XT desires to grant to Licensee and Licensee desires to acquire from XT
an exclusive worldwide license or sublicense, as the case may be, under the
Licensed Technology to commercialize Products, 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.
1.1 "ABX" shall mean Abgenix, Inc.
1.2 "Affiliate" shall mean any entity which controls, is
controlled by or is under common control with any one of ABX, JTI or XT. An
entity shall be regarded as in control of another entity if it owns or controls
at least fifty percent (50%) of the shares 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);
provided, however, XT shall not be an Affiliate of ABX or JTI under this
Agreement and XT shall not be considered controlled by ABX or JTI for purposes
of determining Affiliates of ABX or JTI.
1.3 "Antibody" shall mean a composition comprising a whole
antibody or a fragment thereof, said antibody or fragment having been derived
from the Licensed Technology and/or generated from the Mice or the Future
Generation Mice or having been derived from nucleotide sequences encoding, or
amino acid sequences of, such an antibody or fragment.
1.4 "Antibody Product" shall mean any product comprising an
Antibody or Genetic Material encoding an Antibody wherein, in respect of each
Antibody Product, said Genetic Material does not encode multiple Antibodies.
1.5 "Antibody-Secreting Cell" shall mean a cell that secretes an
Antibody, except where such cell is part of a mammal.
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1.6 "Antigen Technology" shall mean (i) all U.S. patent
applications and patents listed on Schedule 1 and patents issuing on such patent
applications owned by or licensed to XT which relate to the Product Antigen, in
each case to the extent XT has the right to license or sublicense the same; (ii)
any continuations, divisionals, reexaminations, reissues or extensions of any of
(i) above; (iii) any foreign counterparts issued or issuing on any of (i) or
(ii) above; and (iv) materials as set forth in Schedule 1.
1.7 "CGI" shall mean Cell Genesys, Inc.
1.8 "Effective Date" shall mean the date this Agreement is
executed by XT and Licensee.
1.9 "Future Generation Mice" shall have the meaning defined in
the Master Research License and Option Agreement, as amended.
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" shall mean that certain Cross
License Agreement, effective as of March 26, 1997, entered into by and among the
parties, GenPharm International, Inc. ("GenPharm") and the other parties named
therein, as the same may be amended from time to time.
1.12 "IND" shall mean an Investigational New Drug Exemption for a
Product, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, or its non-U.S. equivalent.
1.13 "JTI" shall mean Japan Tobacco Inc.
1.14 "License Fee" shall have the meaning set forth in Article 3
hereof.
1.15 "Licensed Field" shall mean all human medical uses.
1.16 "Licensed Technology" shall mean the Antigen Technology, the
XenoMouse(TM) Technology, and XT-Controlled Rights.
1.17 "Master Research License and Option Agreement" shall mean
that certain Master Research License and Option Agreement entered into by CGI,
JTI and XT as of June 28, 1996 (and subsequently assigned by CGI to ABX), as it
may be amended.
1.18 "Mice" shall have the meaning defined in the Master Research
License and Option Agreement, as amended.
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1.19 "Net Sales" shall mean [Redacted]
1.20 "Product" and "Products" shall mean one or more Antibody
Products which incorporate (i) an Antibody which binds to the Product Antigen or
(ii) Genetic Material encoding such an Antibody wherein said Genetic Material
does not encode multiple antibodies.
1.21 "Product Antigen" shall mean ____________________.
1.22 "Sublicensee" shall mean a third party that is not an
Affiliate (provided, however, that CGI may be a Sublicensee of ABX, whether or
not CGI is an Affiliate of ABX) to whom Licensee has granted a sublicense under
the Licensed Technology to make, use and/or sell Products to the extent of the
rights of Licensee therein. "Sublicensee" shall also include a third party to
whom Licensee has granted the right to distribute Products under the Licensed
Technology to the extent of the rights of Licensee therein, provided that such
third party is responsible for the marketing and promotion of Products within
the applicable country.
1.23 "Territory" shall mean all the countries of the world.
1.24 "Transgenic Product" shall mean any product constituting (i)
Mice or Future Generation Mice, (ii) Genetic Material from Mice or Future
Generation Mice, or (iii) an Antibody-Secreting Cell.
1.25 "Universal Receptor Product" shall mean a substance that is
developed utilizing both (i) an Antibody and (ii) Universal Receptor Technology.
1.26 "Universal Receptor Technology" shall mean technology for
universal receptors [*] As used herein: (i) "universal receptor" shall mean a
receptor [*]
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1.27 "Valid Claim" shall mean a claim of a pending or issued, and
unexpired patent included within the Licensed Technology, which has not been
held unenforceable, unpatentable or invalid by a court or other governmental
agency of competent jurisdiction, and which has not been admitted to be invalid
or unenforceable through reissue, disclaimer or otherwise.
1.28 "XenoMouse(TM) Technology" shall mean (i) all U.S. patent
applications and patents listed on Schedule 2 and patents issuing on such
applications; (ii) any continuations, divisionals, reexaminations, reissues or
extensions of any of (i) above; (iii) any foreign counterparts issued or issuing
on any of (i) or (ii) above; and (iv) the Mice (as such term is defined in the
Master Research License and Option Agreement) and other materials as set forth
on Schedule 2.
1.29 "XT-Controlled Rights" shall mean all rights to patents or
technology that are licensed to XT pursuant to the agreements listed on Schedule
4 or any other license or similar agreement granting XT rights to patents or
technology (each such agreement an "XT In-License"), to the extent that XT has
the right under the terms of the applicable XT In-License to further license or
sublicense such rights during the Term of this Agreement.
1.30 "XT In-License" shall have the meaning set forth in Section
1.29, above.
2. LICENSE GRANT; USE OF MICE BY THIRD PARTIES.
2.1 Subject to the terms and conditions of this Agreement, XT
hereby grants to Licensee an exclusive license or sublicense, as the case may
be, under the Licensed Technology, to make and have made Products 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 such
Products in the Licensed Field in the Territory. Such license or sublicense
shall be exclusive even as to XT, and shall include the exclusive right to grant
and authorize sublicenses for exploitation worldwide; provided, however, that
Licensee may not, under this license, grant sublicenses to any rights to the
Mice except as provided in Section 2.2 of this Agreement.
2.2 In connection with the grant of a sublicense under this
Agreement to a third party, and notwithstanding any provision to the contrary in
the Master Research License and Option Agreement or any Material Transfer
Agreement entered into between the parties under Sections 2.1, 2.2 or 2.3 of the
Master Research License and Option Agreement, Licensee shall have the right to
grant a sublicense to use Mice and Future Generation Mice transferred to the
third party pursuant to the terms of Section 2.7 of the Master Research License
and Option Agreement, and Transgenic Products other then Mice or Future
Generation Mice, to research, develop, make, have made, use, import, export,
sell, lease, offer to sell or lease or otherwise distribute or commercialize
Products, with the proviso that the sublicense described in this Section 2.2
shall not exceed the Licensee's rights conferred in accordance with the Master
Research License and Option Agreement or this Product License.
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2.3 It is understood and agreed that, as to all XT-Controlled
Rights, the grant of rights under this Article 2 shall be subject in all
respects to the applicable XT In-License(s) pursuant to which such XT-Controlled
Rights were granted to XT.
3. LICENSE FEE.
Licensee shall pay to XT within thirty days of the Effective Date a
license fee of [Redacted].
4. ROYALTIES.
4.1 Royalty Rates. In consideration for the license and rights
granted herein, Licensee agrees to pay to XT royalties [Redacted].
4.2 Royalty Offsets. In the event that (i) Licensee, its
Affiliate or Sublicensee is required to pay a non-Affiliate third party amounts
with respect to Products under agreements for patent rights or other
technologies which Licensee, its Affiliate or Sublicensee, in its reasonable
judgment, determines are necessary or desirable to license or acquire with
respect to such Products (excluding any such payments made to Licensee by its
Affiliates), or (ii) any reimbursement payments are due to XT pursuant to
Section 5.1 below, then Licensee may deduct the aggregate of any such amounts
from any royalty amount owing to XT for the sale of such Products pursuant to
Section 4.1 above; provided, however, that payments from Licensee to a third
party that is an Affiliate, or was an Affiliate at any time within two (2) years
prior to the Effective Date, may not be offset under this Section 4.2.
Notwithstanding the foregoing provisions of this Section 4.2, in no event shall
the royalties due to XT pursuant to Section 4.1 above be so reduced to less than
[*] of the amount that would otherwise be due to XT thereunder. [*]
4.3 Single Royalty; Non-Royalty Sales. Only one royalty shall be
payable with respect to any Product, regardless of how many claims or patents
within the Licensed Technology cover such Product. In addition, no royalty shall
be payable under this Article 4 with respect to sales of Products among Licensee
and its Affiliates and/or Sublicensees and their Affiliates or for use in
research and/or development or clinical trials.
4.4 No Patent Protection. Royalties shall be payable at the rates
specified in Section 4.1 or 4.2 above only with respect to sales of Products
that would infringe a Valid Claim in the country in which such Products are
sold. In the event that such Products are not covered by a Valid Claim in such
country, XT shall be paid a royalty on such sales in accordance with this
Article 4, but the royalty due XT with respect to Net Sales in such country will
equal [*] of the royalty set forth in Section 4.1 or as it may be offset under
Section 4.2.
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4.5 Combination Products. 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 amounts due under
this Article 4 shall be calculated by multiplying the Net Sales of that
combination by the fraction A/(A + B), where A is the gross selling price of the
Product sold separately and B is the gross selling price of the other product
sold separately. In the event that no such separate sales are made in the same
quarter by Licensee, Net Sales for royalty determination shall be as reasonably
allocated by Licensee, between such Product and such other product, based upon
their relative importance and proprietary protection.
4.6 Termination of Royalties. Royalties under Section 4.1, 4.2,
or 4.4 will be due until the later of (i) ten years from the first commercial
sale of Products in any country or (ii) on a country-by-country basis, the
expiration of the last-to-expire patent within the Licensed Technology covering
the Products in such country.
5. THIRD PARTY ROYALTIES.
5.1 Royalties Payable by XT. XT will be responsible for the
payment of any royalties, license fees and milestone and/or other payments due
to third parties under licenses or similar agreements entered into by XT
necessary to allow the manufacture, use or sale of Products. Licensee shall
reimburse XT for any royalties paid by XT to third parties under licenses or
similar agreements covering Products necessary to allow the manufacture, use or
sale or other exploitation of Products anywhere in the world. Licensee shall
continue any such reimbursement payments to XT until XT's obligation to pay
royalties to a third party under any license covering Products expires or
terminates. XT agrees not to enter into any license or similar agreement after
the Effective Date which would obligate Licensee to make any payments under this
Section 5.1 without the prior written consent of Licensee.
5.2 Royalties Payable by Licensee. Xenotech shall have no
responsibility under the terms of this Agreement for the payment of any
royalties, license fees or milestone or other payments due to third parties
under licenses or similar agreements entered into by Licensee, its Affiliates,
or its Sublicensees to allow the manufacture, use or sale of Products.
6. ACCOUNTING AND RECORDS.
6.1 Royalty Reports and Payments. After the first commercial sale
of Products on which royalties are required, Licensee agrees to make quarterly
written reports to XT within eighty days after the end of each calendar quarter,
stating in each such report the number, description, and aggregate Net Sales of
Products sold during the calendar quarter upon which a royalty is payable under
Article 4 above. Concurrently with the making of such reports, Licensee shall
pay to XT royalties at the applicable rate specified in Section 4.1, 4.2 or 4.4
above and all royalties payable pursuant to Section 5.1 above, and any
adjustment to Net Sales for a prior period in accordance with the definition of
Net Sales
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in Section 1.11 hereof. All payments to XT hereunder shall be made in U.S.
Dollars to a bank account designated by XT.
6.2 Early Third Party License Payments. If XT is obligated to pay
royalties to a third party prior to ninety days after the end of the calendar
quarter, XT shall so notify Licensee and Licensee shall provide the reports and
payments set forth in Section 6.1 above not later than ten days before the date
such payments are due to the third party. Up to thirty-five days before such
payments are due, XT may provide Licensee with an invoice by facsimile setting
forth the royalties XT must pay third parties with respect to Licensee's
activities in the Territory in the preceding quarter, and Licensee shall pay
such invoices within thirty days of receipt of such invoice.
6.3 Records; Inspection. Licensee 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 XT under this Agreement. Such books and records shall be kept at the
principal place of business of Licensee 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 Licensee or its Affiliates will
be open for inspection during such three-year period by a representative of XT
for the purpose of verifying the royalty statements. Licensee 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
Licensee reasonably satisfactory to XT on behalf of, and as required by, XT 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 XT and Licensee. The XT representative will be obliged to execute a
reasonable confidentiality agreement prior to commencing any such inspection.
Inspections conducted under this Section 6.3 shall be at the expense of XT,
unless a variation or error producing an increase exceeding [Redacted] of the
amount stated for the period covered by the inspection is established in the
course of any such inspection, whereupon all costs relating thereto will be paid
by Licensee. Upon the expiration of three years following the end of any fiscal
year, the calculation of royalties payable with respect to such year shall be
binding and conclusive, and Licensee shall be released from any liability or
accountability with respect to royalties for such year.
6.4 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.
6.5 Late Payments. Any payments due from Licensee that are not
paid on the date such payments are due under this Agreement shall bear interest
to the extent permitted by applicable law at the prime rate as reported by the
Bank of America in San Francisco, California on the date such payment is due,
plus an additional [Redacted], calculated on the number of days such payment is
delinquent. This Section 6.5 shall in no way limit any other remedies available
to any party.
6.6 Withholding Taxes.
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6.6.1 Unless immediately reimbursable under Section 6.6.2
below, all payments required to be made pursuant to Articles 3, 4 and 5 hereof
shall be without deduction or withholding for or on account of any taxes (other
than taxes imposed on or measured by net income) or similar governmental charge
imposed by a jurisdiction. Such taxes are referred to herein as "Withholding
Taxes" and such 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.
6.6.2 XT agrees to elect to claim a tax credit for
Withholding Taxes with respect to which it is entitled so to elect, and further
agrees not to amend such election for the full carry-forward period with respect
to such credit. At the time that XT realizes a reduction in U.S. tax liability
by actually utilizing the Withholding Taxes as a credit against regular U.S. tax
liability (determined on a "first-in-first-out" basis pro rata with other
available foreign tax credits), then the amount of such reduction attributable
to such credit shall immediately be reimbursed to the withholding party. For
these purposes, a reduction in U.S. tax liability shall include both a direct
reduction in XT's own tax liability and a reduction in the U.S. tax liability of
any of its partners.
6.7 Tax Indemnity. Except as provided in Section 6.6, each party
(the "Tax Indemnitor") shall indemnify and hold harmless the other party hereto
(each a "Tax Indemnitee") from and against any tax or similar governmental
charge assessed solely because of this Agreement with respect to and directly
attributable to the income or the assets of the Tax Indemnitor. In the event
that any governmental agency shall make a claim against a party hereto which
could give rise to an indemnity hereunder, such potential Tax Indemnitee shall
give reasonably prompt notice to the potential Tax Indemnitor of the assertion
of such claim. If the transmission of such notice is unreasonably deferred and
has a material, adverse affect on the ability of the potential Tax Indemnitor to
challenge such claim, such potential Tax Indemnitor shall be released from
liability hereunder. The Tax Indemnitor alone shall (at its own expense) control
the defense or compromise of any such claim. The Tax Indemnitee shall execute
any documents required to enable Tax Indemnitor to defend such claim, provide
any information necessary therefor, and cooperate with Tax Indemnitor in such
defense.
6.8 XT Tax Indemnity. XT shall indemnify and hold harmless
Licensee and its Affiliates from and against any increase to its country of
incorporation income tax liability directly attributable to a positive
adjustment to the amount of gross receipts (an "Adjustment") reported or
reportable by such party from the income, including the royalty income, received
from Licensee on Covered Products. The amount payable hereunder shall be equal
to the difference between (a) the product of (i) the amount of the Adjustment,
and (ii) the highest combined marginal corporate tax rate in the country of
incorporation in effect for the taxable year for which such Adjustment is made,
and (b) the reduction in the party's foreign tax liability, which for purposes
of this Agreement shall be equal to the product of (i) the amount of any
correlative adjustment to its foreign taxable income, and (ii) the highest
combined marginal foreign corporate tax rate in effect for the taxable year for
which the correlative adjustment is made. No indemnification payment shall be
required hereunder until comprehensive efforts to obtain a correlative
adjustment to Licensee's or its Affiliates', as the case may be, taxable income
in a foreign state (which may include, for example invoking competent authority
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provisions under the U.S. Japanese Income Tax Treaty (if applicable) or other
applicable bilateral tax treaty) have, to the extent reasonable to do so, been
exhausted.
7. RESEARCH AND DEVELOPMENT.
7.1 Funding and Conduct. Licensee shall independently furnish and
be responsible for funding and conducting all of its preclinical and clinical
research and development of Products, at its own expense.
7.2 Biomaterials. In the case of Previously Selected Antigens as
defined in the Master Research License and Option Agreement, at the reasonable
request of Licensee, XT shall make available as part of the license granted
hereunder to Licensee [*]. Such hybridomas, reagents and materials, as well as
the related data thus made available will be used only by Licensee and its
Affiliates and Sublicensees and manufacturing subcontractors.
8. DUE DILIGENCE.
8.1 Reasonable Commercial Efforts; IND Milestone.
8.1.1 Licensee agrees to use commercially reasonable
efforts consistent with prudent business judgment to commercialize Products, by
the filing of an IND by Licensee, or its Affiliate or Sublicensee, in the United
States or Japan within such period of time as may be agreed upon by the parties
after good faith negotiations taking into account factors relating to the
Product Antigen or, if no such period is agreed upon, three years from the
Effective Date.
8.1.2 Notwithstanding the foregoing, Licensee shall be
required actively and continuously to pursue the filing of an IND by Licensee,
or its Affiliate or Sublicensee, as soon as practicable after the Effective Date
using reasonable commercial efforts consistent with prudent business judgment.
After filing of an IND, Licensee, or its Affiliate or Sublicensee, shall be
required to have an active IND and to be actively conducting clinical trials in
pursuit of regulatory approval for the Products in the United States or Japan.
8.2 Failure to Meet Due Diligence Obligation.
8.2.1 If the diligence requirements set forth in Section
8.1 are not met by Licensee (or its Affiliates or Sublicensees) in the United
States or in Japan, Licensee's rights hereunder shall terminate upon written
notice by XT to Licensee and subject to Sections 8.3, 8.4 and 13.3 below.
8.2.2 Notwithstanding Section 8.2.1, the license granted
hereunder to Licensee shall not terminate by reason of a delay in meeting the
IND milestone set forth in Section 8.1.1, to the
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extent that prudent business judgment, based on circumstances outside of
Licensee's reasonable control, reasonably justifies such delay.
8.3 Dispute Resolution. In the event that a dispute arises
whether the diligence requirements in Article 8 have been met or circumstances
exist which Licensee believes justifies a failure on its part to meet such
obligation, the parties will attempt to resolve any dispute by mutual agreement
during a period of 30 days following Licensee's receipt of the notice under
Section 8.2.1.
8.4 Arbitration. In the event that the parties are unable to
resolve such dispute pursuant to Section 8.3 above, such dispute shall be
settled between XT and Licensee by binding arbitration as set forth in Section
14.12. If the arbitrator determines that the party acted in good faith, but
failed to meet its obligations under Section 8.1 above, the license granted to
such party shall not terminate unless the nonperforming party fails to cure such
non-performance within a reasonable period of time, as determined by the
arbitrator.
9. PATENTS.
9.1 XenoMouse Technology.
(a) XT or its licensor, as they may agree, shall have
responsibility for preparing, filing, prosecuting and maintaining patents and
patent applications worldwide relating to the XenoMouse Technology and
conducting any interferences, oppositions, reexaminations, or requesting
reissues or patent term extensions with respect to the XenoMouse Technology. XT
shall keep Licensee reasonably informed as to the status of such patent matters,
including without limitation, by providing Licensee the opportunity to review
and comment on any substantive documents which will be filed in any patent
office, and providing Licensee copies of any substantive documents received by
XT from such patent offices including notice of all interferences,
reexaminations, oppositions or requests for patent term extensions. Licensee
shall cooperate with and assist XT in connection with such activities, at XT's
request and expense.
(b) In the event that Licensee becomes aware that any
XenoMouse 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, Licensee shall promptly notify
XT and XT shall thereafter promptly notify the owner of such intellectual
property. XT or its licensor, as they may agree, shall have the exclusive right
to enforce, or defend any declaratory judgment action, at its expense, involving
any XenoMouse Technology. In such event, XT shall keep Licensee reasonably
informed of the progress of any such claim, suit or proceeding. Any recovery
received by XT as a result of any such claim, suit or proceeding shall be used
first to reimburse XT for all expenses (including attorneys, and professional
fees) incurred in connection with such claim, suit or proceeding, and the
remainder divided [*] between XT and Licensee, only to the extent that such
recovery is related to the Products.
9.2 Antigen Technology.
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9.2.1 Licensee shall, at its expense, have the initial
worldwide responsibility for preparing, filing, prosecuting and maintaining
patent applications and conducting any interferences, oppositions,
reexaminations, or requesting reissues or patent term extensions with respect to
Antigen Technology, except to the extent XT may not have the right to do so.
Licensee shall give XT the opportunity to review the status of all such pending
patent applications and actions and shall keep XT fully informed of the progress
of such applications and actions, including, without limitation, by promptly
providing XT with copies of all substantive worldwide correspondence sent to and
received from patent offices, and providing notice of all interferences,
reexaminations, oppositions or requests for patent term extensions. In the event
that Licensee declines or fails to prepare, file, prosecute or maintain such
patent applications or patents or take such other actions, relating to the
Products in any country, it shall promptly and in no event later than ninety
days prior to any filing deadline, provide notice to XT. XT shall have the right
to assume such responsibilities at its own expense, using counsel of its choice.
9.2.2 In the event that Licensee becomes aware that any
Antigen Technology is infringed or misappropriated by a third party in any
country of the world, or is subject to a declaratory judgment action arising
from such infringement in any country, Licensee shall promptly notify XT and XT
shall thereafter promptly notify the owner of such intellectual property.
Licensee shall have the exclusive right to enforce, or defend any declaratory
judgment action, in any country of the world, at its expense, involving any
Antigen Technology. In such event, Licensee shall keep XT reasonably informed of
the progress of any such claim, suit or proceeding. Any recovery by Licensee
received as a result of any such claim, suit or proceeding shall be used first
to reimburse Licensee for all expenses (including attorneys, and professional
fees) incurred in connection with such claim, suit or proceeding, and the
remainder divided [*] between Licensee and XT.
9.3 Infringement Claims. If the production, sale or use of
Products pursuant to this Agreement results in any claim, suit or proceeding
alleging patent infringement against Licensee (or its Affiliates or
Sublicensees), Licensee shall promptly notify XT thereof in writing setting
forth the facts of such claim in reasonable detail. Except where (i) the claim
is determined pursuant to Article 10 of the Master Research License and Option
Agreement to involve Core Technology (as defined therein) or (ii) the claim
involves Additional Technology as defined in the Technology Exchange Agreement
among CGI, JTI and XT dated March 22, 1996 (and subsequently assigned by CGI to
ABX), as it may be amended from time to time, Licensee shall have the exclusive
right to defend and control the defense of any such claim, suit or proceeding,
at its own expense, using counsel of its choice. Licensee shall keep XT
reasonably informed of all material developments in connection with any such
claim, suit or proceeding as it relates to the Licensed Technology, Licensee
shall have the right to deduct any damages and expenses (including attorneys'
and professional fees) against any amounts due, or which may become due, to XT
pursuant to this Agreement. Notwithstanding the above, Licensee shall not be
able to settle any such claim, suit or proceeding that involves any admission of
the invalidity of the Licensed Technology.
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9.4 Patent Marking. Licensee agrees to xxxx and have its
Affiliates and 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.
10. CONFIDENTIALITY.
10.1 Confidential Information. Except as expressly provided
herein, the parties agree that, for the term of this Agreement and for five
years thereafter, the receiving party shall keep completely confidential and
shall not publish or otherwise disclose and shall not use for any purpose any
information furnished to it by another party hereto pursuant to this Agreement
except to the extent that it can be established by the receiving party by
competent proof that such information:
(a) was already known to the receiving party, other than
under an obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise
part of the public domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement; or
(d) was subsequently lawfully disclosed to the receiving
party by a person other than a party or developed by the receiving party without
reference to any information or materials disclosed by the disclosing party.
10.2 Permitted Disclosures. Notwithstanding Sections 10.1 above
and 14.16 below, each party hereto may disclose the other party's information to
the extent such disclosure is reasonably necessary in filing or prosecuting
patent applications, prosecuting or defending litigation, complying with
applicable governmental regulations or otherwise submitting information to tax
or other governmental authorities, making a permitted sublicense or other
exercise of its rights hereunder or conducting clinical trials, provided that if
a party is required to make any such disclosure of the other party's secret or
confidential information, other than pursuant to a confidentiality agreement, it
will give reasonable advance notice to the latter party of such disclosure
requirement and, save to the extent inappropriate in the case of patent
applications, will use efforts consistent with prudent business judgment to
secure confidential treatment of such information prior to its disclosure
(whether through protective orders or otherwise). Notwithstanding the foregoing,
XT shall not disclose to third parties, clinical data or regulatory filings
received from Licensee except as agreed in writing by Licensee.
11. SUBLICENSES.
Pursuant to Article 2 herein, Licensee will have the right to grant and
authorize sublicenses to third parties; provided, however, the Licensee shall
remain responsible for any payments due XT for Net
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Sales of Products by any Sublicensee. Licensee may retain any amounts received
from Sublicensees in excess of the amounts owed to XT pursuant to Articles 4 and
5. Any sublicense granted by Licensee pursuant to this Agreement shall provide
that the Sublicensee will be subject to the applicable terms of this Agreement.
Licensee shall provide XT with a copy of relevant portions of each sublicense
agreement, as reasonably required by XT.
12. REPRESENTATIONS AND WARRANTIES.
12.1 XT. XT represents and warrants that:
(i) it has the full right and authority to enter into this
Agreement and grant the rights and licenses granted herein;
(ii) it has not previously granted and will not grant any
rights inconsistent or in conflict with the rights and licenses granted to
Licensee herein;
(iii) there are no existing or threatened actions, suits
or claims pending against XT with respect to the Licensed Technology or the
right of XT to enter into and perform its obligations under this Agreement;
(iv) it has not previously granted, and will not grant
during the term of this Agreement, any right, license or interest in and to the
Licensed Technology, or any portion thereof, with respect to the Products, or
their manufacture or use;
(v) Schedule 3 hereto sets forth all royalties, license
fees, milestone payments and similar payments due to third parties for which
Licensee is obligated to reimburse XT under Section 5.1 above as of the
Effective Date; and
(vi) the Licensed Technology is all the technology owned
by or licensed to XT as of the Effective Date.
12.2 Licensee. Licensee represents and warrants that:
(i) it has the full right and authority to enter into this
Agreement,
(ii) to its knowledge, there are no existing or threatened
actions, suits or claims pending with respect to the subject matter hereof or
the right of Licensee to enter into and perform its obligations under this
Agreement; and
(iii) it has not entered and during the term of this
Agreement will not enter any other agreement inconsistent or in conflict with
this Agreement.
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12.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, XT MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF LICENSED
TECHNOLOGY CLAIMS, ISSUED OR PENDING.
12.4 Effect of Representations and Warranties. It is understood
that if the representations and warranties under this Article 12 are not true
and accurate and a party incurs liabilities, costs or other expenses as a result
of such falsity, the party at fault shall indemnify, defend and hold the injured
party harmless from and against any such liabilities, costs or expenses
incurred, provided that the party at fault receives prompt notice of any claim
against the injured party resulting from or related to such falsity and the sole
right to control the defense or settlement thereof.
13. TERM AND TERMINATION.
13.1 Effectiveness. This Agreement shall become effective as of
the Effective Date and the license rights granted by XT under Article 2 above
shall be in full force and effect as of such date.
13.2 Term. Unless earlier terminated pursuant to the other
provisions of this Article 13, this Agreement shall continue in full force and
effect until the later of
(i) the expiration of the last to expire patent within the
Licensed Technology claiming Products; or
(ii) the twentieth anniversary of the Effective Date.
The licenses granted under Article 2 shall survive the expiration (but not an
earlier termination) of this Agreement; provided that such licenses shall in
such event become nonexclusive.
13.3 Termination for Breach. Either party to this Agreement may
terminate this Agreement in the event the other party shall have materially
breached or defaulted in the performance of any of its material obligations
hereunder, and such shall have continued for sixty days after written notice
thereof was provided to the breaching party by the nonbreaching party that
terminates the Agreement as to such party. Any termination shall become
effective at the end of such sixty day period unless the breaching party has
cured any such breach or default prior to the expiration of the sixty day
period. However, if the party alleged to be in breach of this Agreement disputes
such breach within such sixty day period, the non-breaching party shall not have
the right to terminate this Agreement unless it has been determined by an
arbitration proceeding in accordance with Section 14.12 below that this
Agreement was materially breached, and the breaching party fails to cure such
breach within thirty days following the final decision of the arbitrators or
such other time as directed by the arbitrators.
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13.4 Other Termination Rights. Licensee may terminate this Agreement and
the license granted herein, in its entirety or as to any particular patent
within the Licensed Technology in a particular country, at any time, by
providing XT ninety-days written notice. In the event of termination as to a
particular country, the subject patent in such country shall cease to be within
the Licensed Technology for all purposes of this Agreement.
13.5 Effect of Termination.
13.5.1 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.
13.5.2 In the event this Agreement is terminated for any reason,
Licensee and its Affiliates and Sublicensees shall have the right to sell or
otherwise dispose of the stock of any Products subject to this Agreement then on
hand. Upon termination of this Agreement by XT for any reason, any sublicense
granted by Licensee hereunder shall survive, provided that upon request by XT,
such Sublicensee promptly agrees in writing to be bound by the applicable terms
of this Agreement.
13.5.3 This Agreement, including, without limitation, any
licenses or sublicenses granted pursuant to this Agreement, shall survive any
dissolution, liquidation or acquisition of XT. Such licenses shall remain in
full force and effect even after any distribution, following dissolution, of the
intellectual property owned or licensed to XT, to any entity. Any transfer of
such intellectual property prior to or following dissolution shall be subject to
the licenses granted herein.
13.5.4 This Agreement, including the license granted in Article
2, is independent of, and shall not be affected by, any breach or termination of
the Master Research License and Option Agreement or any other agreement between
the parties or their Affiliates. In the event of the termination of the Master
Research License and Option Agreement, the rights and obligations of the parties
hereto under Article 12 thereof shall be deemed to be part of this Agreement.
13.5.5 Sections 6.3, 6.5, 6.6, 6.7 and 6.8 and Articles 10, 12,
13 and 14 shall survive the expiration and any termination of this Agreement for
any reason.
14. MISCELLANEOUS.
14.1 Governing Laws. This Agreement shall be interpreted and
construed in accordance with the laws of the State of California, without regard
to conflicts of law principles.
14.2 Waiver. It is agreed that 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.
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14.3 Assignment. This Agreement and the license granted hereunder
may not be assigned by Licensee to any third party without the written consent
of XT, and XT may not assign this Agreement to a third party without the consent
of Licensee; except any party may assign this Agreement without such consent to
(a) an Affiliate (provided that such Affiliate is two-thirds or greater owned
directly or indirectly) or (b) an entity that acquires substantially all of the
assets of the monoclonal antibody business segment of the assigning party. The
terms and conditions of this Agreement shall be binding on and inure to the
benefit of the permitted successors and assigns of the parties.
14.4 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.
14.5 Compliance with Laws. In exercising their rights under this
license, the parties shall fully comply with the requirements of any and all
applicable laws, regulations, rules and orders of any governmental body having
jurisdiction over the exercise of rights under this license.
14.6 No Implied Obligations. Except as expressly provided in
Article 8 above, nothing in this Agreement shall be deemed to require Licensee
to exploit the Licensed Technology nor to prevent Licensee from commercializing
products similar to or competitive with any Products, in addition to or in lieu
of such Products.
14.7 Notices. Any notice required or permitted to be given to the
parties hereto shall be given in writing and shall be deemed to have been
properly given if delivered in person or when received if mailed by first class
certified mail to the other party 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.
XT: Xenotech, L.P.
000 Xxxxxxxx Xxxxx
Xxxxxx Xxxx, Xxxxxxxxxx 00000
Attn: Chief Financial Officer
Japan Tobacco Inc.: Japan Tobacco Inc.
JT Xxxxxxxx
0-0 Xxxxxxxxx 0-xxxxx
Xxxxxx-xx, Xxxxx 000
Xxxxx
Attn: Vice President
Pharmaceutical Division
with a copy to: JT America Inc.
0000 Xxxxx Xxxxx Xxxxxx, Xxxxx 000
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00
Xxx Xxxxx, XX 00000
Attn: President
and to: Xxxxxxx, Xxxxxx and Xxxxx LLP
000 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx X. Xxxxxx, Esq.
Abgenix, Inc.: Abgenix, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attn: President
with a copy to: Xxxxxx Xxxxxxx Xxxxxxxx &
Xxxxxx, P.C.
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxx X. Xxxxx, Esq.
14.8 Export Laws. Notwithstanding anything to the contrary
contained herein, all obligations of XT and Licensee are subject to prior
compliance with United States [and Japanese]** export regulations and such other
United States [and Japanese]** 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 [and Japan].** Licensee shall use efforts
consistent with prudent business judgment to obtain such approvals. XT shall
cooperate with Licensee and shall provide assistance to Licensee as reasonably
necessary to obtain any required approvals.
14.9 Severability. In the event that any provision of this
Agreement becomes or is declared by a court of competent jurisdiction to be
illegal, unenforceable or void, this Agreement shall continue in full force and
effect without said provision and the parties shall discuss in good faith
appropriate revised arrangements.
14.10 Force Majeure. Nonperformance of any party (except for
payment obligations) 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.
14.11 No Consequential Damages. IN NO EVENT SHALL ANY PARTY
HERETO BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF
THIS AGREEMENT OR THE EXERCISE OF RIGHTS HEREUNDER.
14.12 Dispute Resolution; Arbitration. The parties will attempt
to resolve any dispute under this Agreement by mutual agreement, and, if
required, there shall be a face-to-face meeting
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between senior executives of the parties. Any dispute under this Agreement which
is not settled after such meeting, shall be finally settled by binding
arbitration, conducted in accordance with the Rules of Arbitration of the
International Chamber of Commerce by three arbitrators appointed in accordance
with said rules. The arbitration proceedings and all pleadings and written
evidence shall be in the English language. Any written evidence originally in a
language other than English shall be submitted in English translation
accompanied by the original or a true copy thereof. The costs of the
arbitration, including administrative and arbitrators' fees, shall be shared
equally by the parties. Each party shall bear its own costs and attorneys' and
witness' fees. The prevailing party in any arbitration, as determined by the
arbitration panel, shall be entitled to an award against the other party in the
amount of the prevailing party's costs and reasonable attorneys, fees. The
arbitration shall be held in [San Francisco, California]* [Tokyo, Japan, if
initiated by XT against Licensee and in San Francisco, California, if initiated
by Licensee against XT].** A disputed performance or suspended performances
pending the resolution of the arbitration must be completed within thirty days
following the final decision of the arbitrators. Any arbitration shall be
completed within six months from the filing of notice of a request for such
arbitration.
14.13 Complete Agreement. It is understood and agreed between XT
and Licensee that this Agreement constitutes the entire agreement, both written
and oral, between the parties with respect to the subject matter hereof, and
that all prior agreements respecting the subject matter hereof, either written
or oral, expressed or implied, shall be abrogated, canceled, and are null and
void and of no effect. 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 XT and
Licensee.
14.14 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.
14.15 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.
14.16 Nondisclosure. Except as provided in Article 10, each of
the parties hereto agrees not to disclose to any third party the terms of this
Agreement without the prior written consent of each other party hereto, except
to advisors, investors, licensees, sublicensees and others on a need to know
basis under circumstances that reasonably ensure the confidentiality thereof, or
to the extent required by law; provided, however, that the royalty rate
specified in Section 4.1 of this executed Product License shall be redacted
before the terms of this executed Product License are disclosed to potential
licensees and sublicensees. Without limitation upon any provision of this
Agreement, each of the parties hereto shall be responsible for the observance by
its employees, consultants and contractors of the foregoing confidentiality
obligations.
14.17 Conformity with GenPharm Cross-License. The rights and
licenses granted to Licensee hereunder shall be subject to the GenPharm Cross
License, and to the extent that this
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Agreement purports to grant greater rights to Licensee than is permitted under
the GenPharm Cross License, such rights shall be granted only to the extent
permitted under the GenPharm Cross License, and the terms of the GenPharm Cross
License shall control.
IN WITNESS WHEREOF, the parties have executed this Agreement, through
their respective officers hereunto duly authorized, as of the day and year first
above written.
XENOTECH, INC. (as General LICENSEE
Partner of XENOTECH, L.P.)
By: ____________________________ By: _____________________________
Name: __________________________ Name: ___________________________
Title: _________________________ Title: __________________________
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