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EXHIBIT 10.13A
CONFIDENTIAL TREATMENT REQUESTED BY ABGENIX, INC.
AMENDMENT TO MASTER RESEARCH LICENSE AND OPTION AGREEMENT
This Amendment of Master Research License and Option Agreement (the
"Amendment"), effective as of November __, 1997, (the "Amendment Effective
Date"), is made by and between Xenotech, L.P., a California limited partnership
("XT"), Abgenix, Inc. ("ABX"), a Delaware corporation and wholly-owned
subsidiary of Cell Genesys, Inc., a Delaware corporation ("CGI"), and Japan
Tobacco Inc., a Japanese corporation ("JT"), and amends that certain Master
Research License and Option Agreement among JT, ABX, and XT effective as of June
28, 1996 (the "1996 Master Agreement").
RECITALS
A. XT is a limited partnership formed in June 1991 by JT Immunotech USA, Inc., a
wholly-owned indirect subsidiary of JT, and CGI to research, develop, use,
modify, make, have made, sell and otherwise dispose of certain products and hold
the rights to certain technology relating to human monoclonal antibodies derived
from transgenic mice.
B. CGI has assigned all of its rights and any obligations under the 1996 Master
Agreement, and various other agreements, to its wholly-owned subsidiary ABX.
C. The parties desire to amend the 1996 Master Agreement to (i) provide for the
transfer of transgenic mice to third parties under certain circumstances
provided herein, (ii) modify the 1996 Master Agreement, and the form Product
Licenses attached thereto, in order to facilitate commercialization of the
XenoMouse(TM) transgenic mice and related technology, and (iii) clarify the
manner in which rights obtained by XT from third parties are incorporated into
the licenses granted under the 1996 Master Agreement.
NOW THEREFORE, it is agreed by and between the parties to amend the 1996 Master
Agreement as follows:
1. All capitalized terms not defined in this Amendment shall have the meanings
given to them in the 1996 Master Agreement.
2. Section 1.10 is amended to read in its entirety as follows:
1.10 "Covered Product" shall mean any Antibody Product which incorporates
(i) an Antibody which binds to a particular Antigen or (ii) Genetic
Material encoding such an Antibody wherein said Genetic Material does not
encode multiple Antibodies.
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3. Section 1.19 is amended to read in its entirety as follows:
1.19 "Licensed Technology" shall mean the [***] Technology, the [***]
Technology, and the XT-Controlled Rights.
4. Sections 1.34 and 1.35 are deleted from the 1996 Master Agreement.
5. The following new Sections 1.37, 1.38, 1.39, 1.40, 1.41, 1.42, 1.43, 1.44
and 1.45 are added following Section 1.36 of the 1996 Master Agreement:
1.37 "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 Mice or Future Generation Mice or
having been derived from nucleotide sequences encoding, or amino acid
sequences of, an antibody obtained from Mice or Future Generation Mice.
1.38 "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.
1.39 "Antibody-Secreting Cell" shall mean a cell that secretes an Antibody,
except where such cell is part of a mammal.
1.40 "Antigen Invention" shall mean intellectual property rights in and to
patentable inventions (including patent and patent applications) which both
(i) include claims to the following:
(A) [***]
(B) [***]
(C) [***]
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respect to the omitted portions.
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(D) [***]
and (ii) wherein, but for a license thereto, such claims would be infringed
by the manufacture, use, sale, offer for sale, or import of Antibody
Products to such Antigen.
1.41 "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.
1.42 "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.
1.43 "Research License" shall have the meaning set forth in Article 3 of
this Agreement.
1.44 "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.
1.45 "XT-Controlled Rights" shall mean all rights to intellectual property
or technology that are licensed to XT pursuant to the agreements listed on
Exhibit H or any other license or similar agreement granting XT rights to
intellectual property 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.
6. Section 2.3 is amended to read in its entirety as follows:
2.3 The Mice shall only be used by a Grantee pursuant to the Research
License set forth in Article 3 hereof for research and development purposes
or pursuant to a Product License and shall not be transferred or otherwise
made available to any third party, except as provided in Sections 2.7 of
this Agreement or as provided under an applicable Product License entered
into between the Grantee and XT.
7. The following new Sections 2.7 and 2.8 shall be inserted following Section
2.6 of the 1996 Master Agreement:
2.7 Transfer of Mice: Notwithstanding any provision to the contrary in this
Agreement or any Material Transfer Agreement entered into between the
parties under Sections 2.1, 2.2 or 2.3 (or any other agreement between
parties to this
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Agreement, as such agreements are amended from time to time), Grantees and XT
shall have the right to transfer physical possession of one or more sterilized
male Mice or sterilized male Future Generation Mice (in each case, sterilized
using a method agreed upon by JT and ABX) or Transgenic Products, but not other
Mice or Future Generation Mice, to third parties (including Affiliates) for
research and development purposes, with the proviso that such research and
development purposes shall not exceed the rights conferred in accordance with
Section 3 hereof; and further provided that, as to transfers of Mice and Future
Generation Mice (but not of other Transgenic Products), Grantees shall only be
permitted to make transfers of such Mice and Future Generation Mice to third
parties on the following terms and conditions:
(a) Mice and Future Generation Mice shall not be transferred to any
third party by a Grantee except under a written agreement (the "Third-Party
Transfer Agreement") providing, among other things, that:
(1) all Mice and Future Generation Mice shall be the property of
the respective owners of such Mice and Future Generation Mice prior to
their transfer to the third party, and the transfer of physical
possession to such third party, and/or possession or use by such third
party, of Mice or Future Generation Mice shall not be, nor be
construed as, a sale, lease, offer to sell or lease, or other transfer
of title to any Mice or Future Generation Mice;
(2) all Mice and Future Generation Mice shall remain in the
control of such third party and shall not be transferred to any other
party (other than the transferring Grantee);
(3) the third party shall not attempt to use the Mice or Future
Generation Mice, or any others materials derived in whole or part from
the Mice or Future Generation Mice (including Genetic Materials) to
reproduce the Mice or Future Generation Mice or to generate or produce
other transgenic mice or other transgenic animals;
(4) if the third party is a for-profit pharmaceutical or
for-profit biotechnology company, [***]; provided, however, that this
provision shall not restrict or prohibit any authorized manufacture,
use, or sale or other commercialization of materials derived from the
Mice or Future Generation Mice in accordance with a license or
sublicense from XT or a Grantee (or a Sublicensee of XT or a Grantee)
under this Agreement, a Product License, or otherwise;
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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(5) the third party shall not sell, have sold, lease, offer to
sell or lease, otherwise transfer title to any Mice, Future Generation
Mice, Antibody-Secreting Cells derived from the Mice or Future
Generation Mice, or (except as provided in (6) below) Genetic
Materials derived from the Mice or Future Generation Mice;
(6) the third party shall not sell, have sold, lease, offer to
sell or lease, otherwise transfer title to, or otherwise distribute or
commercialize any Antibody or Antibody Product without obtaining a
license, sublicense, or other authorization from the transferring
Grantee;
(7) the third party shall not use the Mice or Future Generation
Mice to make or use antibodies to [***]; and
(8) XT shall be a third-party beneficiary of the commitments by
third parties set forth in items (1) through (7) above.
(b) Grantees shall not grant any license, sublicense, or other
authorization of the type described in Section 2.7(a)(6) to third parties
unless such license, sublicense, or other authorization does not conflict
with the applicable terms of this Agreement, any applicable Product
License, and the GenPharm Cross-License.
(c) Nothing in this Section 2.7 shall be construed as granting
Grantees the right to sublicense any third party to sell, have sold, lease,
or offer to sell or lease, any Covered Product, other than pursuant to a
sublicense under a Product License entered into by Grantee under the terms
of this Agreement.
2.8 Transfer of Transgenic Products and Antibody Products: When transferring
physical possession of any Transgenic Product or Antibody Product to a third
party, the transferring Grantee shall obtain a written agreement from the third
party that such transferred materials remain the property of the respective
owner of such materials prior to their transfer to the third party, and the
transfer of physical possession to such third party, and/or possession or use by
such third party, of such materials shall not be, nor be construed as, a sale,
lease, offer to sell or lease, or other transfer of title to such transferred
materials. If a Grantee has authority to sell or otherwise transfer title to
materials pursuant to a Product License, the terms of this Section 2.8 shall not
apply to the transfer of such materials by such Grantee.
8. Article 3 ("Grant of Research License") is amended to read in its entirety
as follows:
3.1 Grant. XT hereby grants to each Grantee a co-exclusive (with each other and
XT), worldwide, royalty-free, fully paid up, perpetual, irrevocable license (or
sublicense, as appropriate) under the Licensed Technology to use for research,
and to
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respect to the omitted portions.
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develop, make, have made, use, import, export or otherwise transfer
physical possession of (but not to sell, lease, offer to sell or lease, or
otherwise transfer title to) Transgenic Products and Antibody Products (the
"Research License"); provided, however, that (i) the right to transfer
physical possession of Mice and Future Generation Mice pursuant to this
Research License shall be limited as set forth in Section 2.7 of this
Agreement, and (ii) as to all XT-Controlled Rights, the foregoing grant
shall be subject in all respects to the applicable XT In-License(s)
pursuant to which such XT-Controlled Rights were granted to XT.
3.2 Sublicenses.
(a) Each Grantee may grant to third parties non-exclusive sublicenses
under the Research License (i) to use Transgenic Products and (ii) to
research, develop, make, have made, use, import and export (but not to
sell, lease, offer to sell or lease, or otherwise transfer title to)
Antibody Products, Antibody-Secreting Cells, and Genetic Materials, solely
for research and development purposes; provided, that the transfer of Mice
and Future Generation Mice by Grantees shall be subject to the restrictions
set forth in Section 2.7 of this Agreement.
(b) [***]; provided, however, that this Subsection 3.2(b) shall not
restrict or prohibit any authorized manufacture, use, or sale or other
commercialization of materials derived from the Mice or Future Generation
Mice in accordance with a license or sublicense from XT or a Grantee (or a
Sublicensee of XT or a Grantee).
(c) Sublicenses under this Section 3.2 shall not include the right to
grant further sublicenses to use the Mice or Future Generation Mice, but
may include the right to grant further sublicenses as to other rights
sublicensed hereunder upon the approval of the Grantee which sublicensed
such rights. Except as set forth in this Section 3.2, Grantees shall have
no other right to grant sublicenses under the Research License unless
otherwise agreed in writing by Xenotech. It is understood that after a
Grantee has entered into a Product License under this Agreement for
Antibody Products related to a particular Antigen, that Grantee may, among
other things, sublicense third parties under such Product License to use
any Mice or Future Generation Mice transferred to that third party by the
Grantee pursuant to Section 2.7 of this Agreement to research, develop,
make, have made, use, import, export, sell, lease, offer to sell or lease,
otherwise transfer title, or otherwise distribute or commercialize Antibody
Products covered by such Product License.
3.3 Direct Sublicense to CGI. With regard to rights and sublicenses under
the GenPharm Cross License sublicensed to ABX under Section 3.1 above
("ABX's
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respect to the omitted portions.
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GenPharm Research Rights"), it is understood and agreed that, in the event
that CGI obtains (i) a sublicense of rights from ABX under a Product
License and (ii) a corresponding sublicense related to the Product Antigen
from XT (a "Direct CGI Sublicense") pursuant to that certain Direct
Sublicense to Cell Genesys entered into by and between CGI and XT effective
as of October __, 1997, the grant of ABX's GenPharm Research Rights under
this Article 3 shall be subject to the Direct CGI Sublicense, and ABX's
GenPharm Research Rights shall be subordinate to the rights granted under
the Direct CGI Sublicense to the extent, and for so long as, required under
the GenPharm Cross License. Upon any termination or expiration of the
Direct CGI Sublicense (and all sublicenses, if any, thereunder), ABX's
GenPharm Research Rights shall no longer be subject to the grant of rights
and sublicenses under the Direct CGI Sublicense.
9. Section 4.2(i)(a) and (b) are amended to read in their entirety as follows:
(a) During the term of this Agreement, the Grantees shall meet [***],
at such times and locations as they may agree. Each Grantee may select
[***] Additional Antigens at [***]. Thereafter, each Grantee may, at such
quarterly meetings, select (i) up to three (3) Additional Antigens per
calendar six-month period during the time from January 1, 1997 to June 30,
1997, and (ii) up to four (4) Additional Antigens per calendar six-month
period thereafter. At the time that a Grantee selects an Antigen [***], it
shall also provide to the other Grantee a summary of the scientific
background to the selection of such Antigen, [***]. Such disclosure shall
be without any warranty regarding, or agreement to license, such rights.
The Grantee selecting an Antigen shall also inform the other Grantee of
[***].
(b) If a Grantee does not select an Additional Antigen at a particular
[***], provided, however, that it may not [***]. Once selected an
Additional Antigen shall [***].
The remainder of Section 4.2 shall not be changed by this Amendment.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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10. Section 6.1 is amended to read in its entirety as follows:
6.1 Limitations on Product Licenses. Upon execution by XT and a Grantee
(and unless and until terminated), each of the Product Licenses shall be
deemed to be a "[***] License." [***], the license shall no longer be
deemed to be a "[***] License." At no time shall either Grantee have the
right to hold [***]. In the event that a Grantee terminates a Product
License in its entirety, such license shall no longer be deemed to be held
by such Grantee for the purpose of the limitations set forth in this
Section 6.1.
11. Section 7.1 is amended to read in its entirety as follows:
7.1 In order to [***]. The right of a Grantee to license or sublicense
pursuant to this Section 7.1 shall not require the consent of the other
Grantee or of XT, and shall not require any additional obligations to XT
other than acceptance by the Grantee of the terms and conditions of the
applicable Exclusive Worldwide Product License from XT to such Grantee
related to the Antigen. A Grantee selecting an Antigen governed by the
terms of this Section 7.1 shall notify the other Grantee, at the time the
Antigen is selected, that this Section 7.1 applies. It is understood and
agreed that the other Grantee [***].
12. Section 7.2 is amended to read in its entirety as follows:
In the event that [***]
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respect to the omitted portions.
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[***]. XT will confer with CGI and JTI as to how to [***].
13. Article 8 is amended to read in its entirety as follows:
8. IN-LICENSING OR ACQUISITION; INVENTIONS
8.1 In-Licensing Third Parties Antigen Inventions.
(a) If either Grantee is licensing or otherwise acquiring from a third
party (or negotiating to license or acquire from a third party) patent
rights in an Antigen Invention that were made by a third party without the
use of Mice or Future Generation Mice, such Grantee (the "In-Licensing
Grantee") [***]. Subject to Section 4.2(iv) above, the Grantee that selects
an Antigen pursuant to Section 4.2(i)(a) above shall [***]. If both
Grantees have selected the same Antigen pursuant to Section 4.2(iv) above,
they shall mutually agree, subject to Section 4.2(iv)(d), on control of
in-licensing negotiations.
(b) If the In-Licensing Grantee licenses or acquires rights to one or
more Antigen Inventions from a third party and secures such rights for the
other Grantee pursuant to Section 8.1(a) above, and [***].
8.2 Inventions By Grantees.
(a) Inventions Made Before Selection. Subject to Sections 8.2(c), 8.4
[***] and 8.7 of this Agreement, each Grantee shall, promptly following the
selection of an Antigen by either Grantee ("selection" referring to the
process
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respect to the omitted portions.
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set forth in Section 4.2 above), disclose to the other all Antigen
Inventions related to that Antigen made, conceived and reduced to practice
by the disclosing Grantee prior to selection of the Antigen. At such time
as the non-disclosing Grantee has [***], the disclosing Grantee shall,
[***].
(b) Inventions Made After Selection. Subject to Sections 8.2(c), 8.4
[***] and 8.7, each Grantee shall, after an Antigen has been selected,
disclose to the other Grantee within a reasonable time after invention all
Antigen Inventions related to that Antigen that are made, conceived and
reduced to practice by the disclosing Grantee after the selection of the
Antigen; provided, however, that such disclosure shall only be required if
the other Grantee, at the time of invention, has [***].
(c) Limitation. Notwithstanding the foregoing Subsections 8.2(a) and
(b), neither Grantee shall be obligated to disclose, license to the other
Grantee, or negotiate for such licenses, each as set forth in Subsections
8.2(a) and (b), for [***]. The limitations set forth in this Section 8.2(c)
shall not limit the obligations set forth in Section 8.3(a).
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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8.3 Inventions Where One Grantee Has Worldwide Exclusive Product License.
(a) Mandatory License to Inventions of Grantee: If either Grantee (the
"Exclusive Grantee") enters into an Exclusive Worldwide Product Sublicense
with respect to a particular Antigen, the other Grantee shall grant to the
Exclusive Grantee, for so long as such Exclusive Worldwide Product License
is in effect, a non-exclusive, worldwide, royalty-free license under all
Antigen Inventions specifically related to such Antigen made, conceived and
reduced to practice by the other Grantee after the time that the Exclusive
Grantee entered into the Exclusive Worldwide Product License.
(b) Mandatory License to Inventions of Third Parties: If either
Grantee (the "Exclusive Grantee") has in effect an Exclusive Worldwide
Product Sublicense with respect to a particular Antigen, the other Grantee
(i) shall not transfer to a third party any Transferred Materials for such
Antigen without the prior written consent of the Exclusive Grantee and (ii)
shall, when negotiating the terms of any material transfer agreement in
connection with transferring to a third party Transferred Materials for
such Antigen, obtain the right to license on a non-exclusive, worldwide,
royalty-free basis, to the other Grantee all Antigen Inventions
specifically related to such Antigen which are made by the third party (or
jointly by the third party and the Grantee) through use of the Transferred
Materials for such Antigen, and shall so license such Antigen Inventions to
the Exclusive Grantee for so long as such Exclusive Worldwide Product
License is in effect.
(c) Transferred Materials for an Antigen. As used in Sections 8.3, 8.4
and 8.5 of this Agreement, "Transferred Materials for X", where "X" is an
Antigen, shall include Mice or Future Generation Mice for use with such
Antigen, Antibody Products comprising Antibodies that bind to such Antigen,
and Antibody-Secreting Cells that secrete such Antibodies and Genetic
Materials that encode such Antibodies.
8.4 Third Party Inventions With Mice- [***]. The terms of this Section 8.4
shall apply when (A) an Antigen (i) has not yet been selected by either
Grantee (or has been selected and later abandoned so that it is again
available for selection) or (ii) has been selected by the transferring
Grantee or (iii) has been selected by both Grantees and both Grantees have
an option to enter into (and/or have entered into) a Co-Exclusive Worldwide
Product License, and (B) a Grantee executes a material transfer agreement
in connection with transferring to a third party Transferred Materials for
such Antigen. It is understood that if an Antigen has been selected by both
Grantees and both Grantees have the option to enter into a Co-Exclusive
Worldwide Product License with respect to such Antigen, then the Grantees
shall [***].
(a) Disclosure. When negotiating the terms of a material transfer
agreement as described in this Section 8.4, [***]
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respect to the omitted portions.
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[***]. It is understood that at such time, if any, as [***].
(b) License Negotiation. When negotiating the terms of a material
transfer agreement as described in this Section 8.4, the transferring
Grantee shall [***].
(c) Limitation. Notwithstanding (a) and (b) above, it is understood
and agreed that neither Grantee shall be obligated to disclose or license
to the other any Antigen Inventions that such Grantee is contractually
prohibited from disclosing or licensing to the other [***].
8.5 Third Party Inventions With Mice - Mandatory Disclosure and Licensing.
The terms of this Section 8.5 shall apply when a Grantee has selected an
Antigen (and has either entered into a Product License with respect to such
Antigen or has the right to acquire such a Product License) and the other
Grantee (the "Transferring Grantee") is negotiating the terms of a material
transfer agreement in connection with transferring to a third party
Transferred Materials for such Antigen. Notwithstanding the foregoing, the
terms of this Section 8.5 shall not apply where the terms of Section 8.4
apply pursuant to Section 8.4(A)(iii).
(a) Mandatory Disclosure. The Transferring Grantee shall obtain the
right to disclose to the Grantee that selected the Antigen all Antigen
Inventions made by a third party (or jointly by the third party and the
Transferring Grantee) through use of the Transferred Materials for such
Antigen transferred under a material transfer agreement as described in
this Section 8.5, and shall thereafter promptly disclose all such Antigen
Inventions to the other Grantee. It is understood that at such time, if
any, as the other Grantee no longer has a Product License or option to
enter into a Product License with respect to the Antigen, the
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respect to the omitted portions.
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Transferring Grantee shall have no obligation to disclose Antigen Inventions for
such Antigen.
(b) Mandatory License. The Transferring Grantee shall obtain the right
to license to the Grantee that selected the Antigen all Antigen Inventions
made by a third party (or jointly by the third party and the Transferring
Grantee) through use of the Transferred Materials for such Antigen
transferred under a material transfer agreement as described in this
Section 8.5. Thereafter, subject to Section 8.3(b), the Transferring
Grantee shall, if the other Grantee has in effect at the time a Product
License for such Antigen, grant a nonexclusive license to all such Antigen
Inventions in the same Territory as set forth in such Product License, and
for so long as such Product License is in effect, on commercially
reasonable terms. It is understood that at such time, if any, as the other
Grantee no longer has a Product License with respect to that Antigen, the
Transferring Grantee shall have no further obligation to license such
Antigen Inventions for the Antigen to the other Grantee.
(c) Prohibition on Transfer of Mice. Neither Grantee shall transfer
Mice or Future Generation Mice to a third party for use with an Antigen
which has been selected by the other Grantee or with respect to which the
other Grantee has entered into a Product License, unless the transferring
Grantee first obtains (i) the right to make the disclosure set forth in
Subsection (a) above and (ii) the ability to grant any license or
sublicense to the other Grantee as required Subsection (b) above.
8.6 Additional Third-Party Inventions Using Mice. The terms of this Section
8.6 shall apply when negotiating the terms of a material transfer agreement
in connection with transferring Mice or Future Generation Mice to a third
party, if such Mice or Future Generation Mice are [***].
(a) [***]. The transferring Grantee shall [***]; provided, however,
that the transferring Grantee shall [***].
(b) [***]. The transferring Grantee shall [***]. It is understood that
[***]
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respect to the omitted portions.
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[***]. Except as the Grantees may otherwise agree, it is understood that
the transferring Grantee shall [***].
8.7 Where Inventing Party Has Exclusive Worldwide Product License. If a
Grantee has entered into an Exclusive Worldwide Product License with
respect to an Antigen, or if a Grantee has an option to enter into such a
Product License and the other Grantee has no Buy-In Right with regard to
such Antigen, the Grantee that has entered into, or has the option to enter
into, the Exclusive Worldwide Product License shall not be subject to the
provisions of this Article 8 regarding Antigen Inventions for such Antigen.
8.8 Terminology. For purposes of clarification, (i) to "disclose" an
Antigen Invention, as that term is used in this Article 8, shall mean
providing the written Disclosure and Record of Invention Form attached
hereto as Exhibit G, and (ii) to "license" an Antigen Invention, as that
terms is used in this Article 8, shall mean to grant a non-exclusive
license under such Antigen Invention to the extent reasonably necessary to
make, have made, use, sell, offer to sell, and import Antibody Products to
such Antigen pursuant to a Product License entered into by the party
receiving such license under such Antigen Invention.
14. The following new Section 17.20 shall be inserted following Section 17.19:
17.20 All rights and licenses granted to Grantees hereunder shall be
subject to the GenPharm Cross License, and to the extent that this
Agreement (or any license or Product License granted or permitted under
this Agreement) purports to grant greater rights to any Grantee than is
permitted under the Cross License, such rights shall be granted only to the
extent permitted under the Cross License, and the terms of the Cross
License shall control.
15. Restated Exhibits A, B, C, and D attached hereto are hereby incorporated
into the 1996 Master Agreement as Restated Exhibits A, B, C, and D of the
1996 Master Agreement, in the place of Exhibits A, B, C, and D,
respectively.
16. Schedule 1 and Schedule 2 of the 1996 Master Agreement are amended to read
in their entirety as set forth in the Schedule 1 and Schedule 2 attached
hereto.
[***] 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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17. Exhibit H attached hereto is hereby incorporated into the 1996 Master
Agreement as Exhibit H of the 1996 Master Agreement.
18. Except as specifically modified or amended hereby, the Agreement shall
remain in full force and effect and, as modified or amended, is hereby
ratified, confirmed and approved. No provision of this Amendment may be
modified or amended except expressly in a writing signed by the parties nor
shall any terms be waived except expressly in a writing signed by the party
charged therewith. This Amendment shall be governed in accordance with the
laws of the State of California, without regard to the principles of
conflicts of laws.
IN WITNESS WHEREOF, each of the parties has executed this Amendment as of
the date indicated on this Amendment.
ABGENIX, INC. JAPAN TOBACCO, INC.
By: /s/ R. Xxxxx Xxxxx By: /s/ Masakazu Kakei
--------------------------------- ------------------------------------
Name: R. Xxxxx Xxxxx Name: Masakazu Kakei
Title: President and CEO Title: Executive Director,
Pharmaceuticals
Date: Date:
XENOTECH, INC. (as General Partner of XENOTECH, L.P.)
By: /s/ Xxxxxxx Xxxxx By: /s/ Xxxxxxx Xxxxx
--------------------------------- ------------------------------------
Name: Xxxxxxx Xxxxx Name: Xxxxxxx X. Xxxxx
Title: President and CEO Title: Chairman
Date: Date:
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Schedule 1
Patent Applications
[***]
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 1
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 1
(Continued)
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 1
(Continued)
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 2 -- Patents
Docket No. Filing Date Serial No. Title Inventors
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 2 - Patents
(Continued)
Docket No. Filing Date Serial No. Title Inventors
[***]
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 2
[***]
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 2
(Continued)
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 2
(Continued)
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Schedule 2
(Continued)
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respect to the omitted portions.
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RESTATED EXHIBIT A
FORM OF EXCLUSIVE WORLDWIDE 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")]* [JAPAN
TOBACCO INC., a Japanese corporation ("JTI")] ** ("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.
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1.5 "Antibody-Secreting Cell" shall mean a cell that secretes an
Antibody, except where such cell is part of a mammal.
1.6 "[***] 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 [***], 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)
[***] 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 [***].
1.16 "Licensed Technology" shall mean the [***] Technology, the [***]
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.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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1.18 "Mice" shall have the meaning defined in the Master Research
License and Option Agreement, as amended.
1.19 "Net Sales" shall mean the [***] charged by Licensee or its
Affiliates and Sublicensees for sales of Product to non-Affiliate customers,
[***], with respect to such sales, and [***], as reflected in [***] of Licensee
and its Affiliates or Sublicensees, to the extent [***]. "Net Sales" for [***]
shall mean [***], where [***] shall mean the [***]. Notwithstanding the
foregoing, [***] shall include [***], but notwithstanding any of the foregoing,
shall not include [***]. Notwithstanding the foregoing, "Net Sales" for [***]
shall be [***].
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.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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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 [***] Universal Receptor Technology.
1.26 "Universal Receptor Technology" shall mean technology for
universal receptors [***]. As used herein: (i) "universal receptor" shall mean a
receptor [***].
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 "[***] 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 [***] 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.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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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.
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 [***].
4. ROYALTIES.
4.1 Royalty Rates. In consideration for the license and rights granted
herein, Licensee agrees to pay to XT royalties of [***] of Net Sales of Products
by it and its Affiliates and Sublicensees.
4.2 Royalty Offsets. In the event that (i) Licensee, its Affiliate or
Sublicensee is required to pay a [***], or (ii) any reimbursement payments are
due to XT pursuant to Section 5.1 below, then Licensee may deduct the aggregate
of
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respect to the omitted portions.
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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, [***].
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 [***]. In the event that no such separate sales are made
in the same quarter by Licensee, Net Sales for royalty determination shall be
[***].
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
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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 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
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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 [***] 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 [***], 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.
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
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respect to the omitted portions.
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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 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 [***] thus made available will be used only by Licensee
and its Affiliates and Sublicensees and manufacturing subcontractors.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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8. DUE DILIGENCE.
8.1 [***].
8.1.1 Licensee agrees to [***] as may be agreed upon by the
parties [***] the Effective Date.
8.1.2 Notwithstanding the foregoing, Licensee shall be [***].
After [***], shall be [***] 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 [***], to the
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.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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9. PATENTS.
9.1 [***] 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 [***] Technology and conducting
any interferences, oppositions, reexaminations, or requesting reissues or patent
term extensions with respect to the [***] 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 [***]
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 [***]
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, [***].
9.2 [***] Technology.
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 [***] 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.
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respect to the omitted portions.
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9.2.2 In the event that Licensee becomes aware that any [***]
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, [***].
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. [***], 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.
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;
[***] 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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38
(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 Sales of Products by any
Sublicensee. [***]. 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;
[***] 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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39
(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.
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.
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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.
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
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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.
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.
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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
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
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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 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
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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 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.
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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.
XENOTECH, INC. (as General LICENSEE
Partner of XENOTECH, L.P.)
By: By:
--------------------------------- ------------------------------------
Name: Name:
------------------------------- ----------------------------------
Title: Title:
------------------------------ ---------------------------------
Schedule 1: Patents [***] Technology"
Schedule 2: Patents [***] Technology"
Schedule 3: Payments Due to Third Parties
Schedule 4: XT In-Licenses
----------
* If ABX is Licensee.
** If JTI is Licensee.
[***] 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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RESTATED EXHIBIT B
FORM OF EXCLUSIVE QUALIFIED WORLDWIDE 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")]* [JAPAN
TOBACCO INC., a Japanese corporation ("JTI")] ** ("Licensee").
RECITALS
XT desires to grant to Licensee and Licensee desires to acquire from XT an
exclusive license or sublicense, as the case may be, in the [ABX]* [JTI]**
Territory and the Rest of the World 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 "ABX Territory" shall mean the United States of America and its
territories and possessions, Canada and Mexico.
1.3 "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.
1.4 "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.
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47
1.5 "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.
1.6 "Antibody-Secreting Cell" shall mean a cell that secretes an
Antibody, except where such cell is part of a mammal.
1.7 "[***] 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 [***], 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)
[***] as set forth in Schedule 1.
1.8 "CGI" shall mean Cell Genesys, Inc.
1.9 "Effective Date" shall mean the date this Agreement is executed
by XT and Licensee.
1.10 "Future Generation Mice" shall have the meaning defined in the
Master Research License and Option Agreement, as amended.
1.11 "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.
1.12 "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.
1.13 "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.
1.14 "JTI" shall mean Japan Tobacco Inc.
1.15 "JTI Territory" shall mean Japan, Taiwan and South Korea
(including the territory comprising North Korea if it should be reunited with
South Korea).
1.16 "License Fee" shall have the meaning set forth in Article 3
hereof.
1.17 "Licensed Field" shall mean [***].
[***] 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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1.18 "Licensed Technology" shall mean the [***] Technology, the [***]
Technology, and XT-Controlled Rights.
1.19 "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.
1.20 "Mice" shall have the meaning defined in the Master Research
License and Option Agreement, as amended.
1.21 "Net Sales" shall mean the [***] charged by Licensee or its
Affiliates and Sublicensees for sales of Product to non-Affiliate customers,
[***], with respect to such sales, and [***], as reflected in [***] of Licensee
and its Affiliates or Sublicensees, to the extent [***]. "Net Sales" for [***]
shall mean [***], where [***] shall mean the [***]. Notwithstanding the
foregoing, [***] shall include [***], but notwithstanding any of the foregoing,
shall not include [***]. Notwithstanding the foregoing, "Net Sales" for [***]
shall be [***].
1.22 "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.
1.23 "Product Antigen" shall mean ____________________.
1.24 "Rest of the World" shall mean all parts of the world not
included in ABX Territory or the JTI Territory.
[***] 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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1.25 "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.
1.26 "Territory" shall mean those countries of the world in which
Licensee has license rights pursuant to this Agreement.
1.27 "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.
1.28 "Universal Receptor Product" shall mean a substance that is
developed utilizing [***] Universal Receptor Technology.
1.29 "Universal Receptor Technology" shall mean technology for
universal receptors [***]. As used herein: (i) "universal receptor" shall mean a
receptor [***].
1.30 "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.
1.31 "[***] 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
[***] 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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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 [***] as set
forth on Schedule 2.
1.32 "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.
1.33 "XT In-License" shall have the meaning set forth in Section 1.32,
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 [ABX]* [JTI]** Territory and the Rest of the World in the Licensed Field.
Such license or sublicense shall be exclusive even as to XT, and shall include
the exclusive right to grant and authorize sublicenses for exploitation in the
Territory; 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.
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 [***].
[***] 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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4. ROYALTIES.
4.1 Royalty Rates. In consideration for the license and rights granted
herein, Licensee agrees to pay to XT royalties of [***] of Net Sales of Products
by it and its Affiliates and Sublicensees.
4.2 Royalty Offsets. In the event that (i) Licensee, its Affiliate or
Sublicensee is required to pay [***], 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, [***].
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 [***]. In the event that no such separate sales are made
in the same quarter by Licensee, Net Sales for royalty determination shall be
[***].
[***] 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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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 in accordance with this Agreement. 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 in Section 1.21 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.
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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 [***] 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 [***], 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.
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
[***] 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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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 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.
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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 [***] thus made available will be used only by Licensee
and its Affiliates and Sublicensees and manufacturing subcontractors.
8. SHARING OF CLINICAL DATA.
As long as their development projects remain on similar timelines, or
as otherwise mutually agreed, Licensee will consider bilateral sharing of its
and its Sublicensees' relevant Product development information and clinical data
with [JTI]* [ABX]**. However, there shall not be, unless otherwise agreed by the
parties, any obligation for sharing data developed independently, by or on
behalf of either of them.
9. DUE DILIGENCE.
9.1 [***].
9.1.1 Licensee agrees to [***] as may be agreed upon by the
parties [***] from the Effective Date.
9.1.2 Notwithstanding the foregoing, Licensee shall be [***].
After [***], shall be [***] in the United States or Japan.
9.2 Failure to Meet Due Diligence Obligation.
9.2.1 If the diligence requirements set forth in Section 9.1 are
not met by Licensee (or its Affiliates or Sublicensees) in [the United States]*
[Japan]**, Licensee's rights hereunder shall terminate upon written notice by XT
to Licensee and subject to Sections 9.3, 9.4 and 14.3 below.
9.2.2 Notwithstanding Section 9.2.1, the license granted
hereunder to Licensee shall not terminate by reason of a delay [***], to the
extent that prudent business judgment, based on circumstances outside of
Licensee's reasonable control, reasonably justifies such delay.
[***] 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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9.3 Dispute Resolution. In the event that a dispute arises whether the
diligence requirements in Article 9 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 9.2.1.
9.4 Arbitration. In the event that the parties are unable to resolve
such dispute pursuant to Section 9.3 above, such dispute shall be settled
between XT and Licensee by binding arbitration as set forth in Section 15.12. If
the arbitrator determines that the party acted in good faith, but failed to meet
its obligations under Section 9.1 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.
10. PATENTS.
10.1 [***] 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 [***] Technology and conducting
any interferences, oppositions, reexaminations, or requesting reissues or patent
term extensions with respect to the [***] Technology. XT shall keep Licensee
reasonably informed as to the status of such patent matters in the Territory,
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 [***]
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 [***]
Technology. In such event, XT shall keep Licensee reasonably informed of the
progress of any such claim, suit or proceeding in the Territory. 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, [***].
10.2 [***] Technology.
10.2.1 XT shall 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 [***] Technology.
[***] 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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XT shall give Licensee the opportunity to review the status of all such pending
patent applications and actions in the Territory and shall keep Licensee fully
informed of the progress of such applications and actions, including, without
limitation, by promptly providing Licensee with copies of all substantive
correspondence sent to and received from patent offices, and providing notice of
all interferences, reexaminations, oppositions or requests for patent term
extensions. Expenses related to such patent and patent applications shall be
divided 66-2/3% -- 33-1/3% on a worldwide basis, between Licensee and XT. In the
event that XT declines or fails to prepare, file, prosecute or maintain such
patent applications or patents or take such other actions, relating to the
Products in the Territory, it shall promptly and in no event later than ninety
days prior to any filing deadline, provide notice to Licensee. Licensee shall
have the right to assume such responsibilities at its own expense, using counsel
of its choice.
10.2.2 In the event that Licensee becomes aware that any [***]
Technology is infringed or misappropriated by a third party in the Territory, or
is subject to a declaratory judgment action arising from such infringement in
such 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 the
Territory, 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, [***].
10.3 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. [***], 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 impinges upon the rights of [JTI]* [ABX]**,
including without limitation, involving any admission of the invalidity of the
Licensed Technology or rights to Product Antigen outside the Territory without
the prior approval of XT.
10.4 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.
[***] 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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11. CONFIDENTIALITY.
11.1 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.
11.2 Permitted Disclosures. Notwithstanding Sections 11.1 above and
15.16 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.
12. 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 Sales of Products by any
Sublicensee. [***]. Any sublicense granted by Licensee pursuant to this
Agreement shall provide that the Sublicensee will be subject to
[***] 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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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.
13. REPRESENTATIONS AND WARRANTIES.
13.1 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.
13.2 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.
13.3 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.
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13.4 Effect of Representations and Warranties. It is understood that
if the representations and warranties under this Article 13 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.
14. TERM AND TERMINATION.
14.1 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.
14.2 Term. Unless earlier terminated pursuant to the other provisions
of this Article 14, 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.
14.3 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 15.12 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.
14.4 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.
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14.5 Effect of Termination.
14.5.1 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.
14.5.2 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.
14.5.3 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.
14.5.4 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.
14.5.5 Sections 6.3, 6.5, 6.6, 6.7 and 6.8 and Articles 11, 13,
14 and 15 shall survive the expiration and any termination of this Agreement for
any reason.
15. MISCELLANEOUS.
15.1 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.
15.2 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.
15.3 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
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Agreement shall be binding on and inure to the benefit of the permitted
successors and assigns of the parties.
15.4 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.
15.5 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.
15.6 No Implied Obligations. Except as expressly provided in Article 9
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.
15.7 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
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.
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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.
15.8 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.
15.9 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.
15.10 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.
15.11 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.
15.12 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 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
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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.
15.13 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.
15.14 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.
15.15 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.
15.16 Nondisclosure. Except as provided in Article 11, 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.
15.17 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 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.
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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.
XENOTECH, INC. (as General LICENSEE
Partner of XENOTECH, L.P.)
By: By:
---------------------------------- -------------------------------------
Name: Name:
-------------------------------- -----------------------------------
Title: Title:
------------------------------- ----------------------------------
Schedule 1: Patents [***] Technology"
Schedule 2: Patents [***] Technology"
Schedule 3: Payments Due to Third Parties
Schedule 4: XT In-Licenses
------------
* If ABX is Licensee.
** If JTI is Licensee.
[***] 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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RESTATED EXHIBIT C
FORM OF EXCLUSIVE HOME TERRITORY 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")]* [JAPAN
TOBACCO INC., a Japanese corporation ("JTI")] ** ("Licensee").
RECITALS
XT desires to grant to Licensee and Licensee desires to acquire from XT an
exclusive license or sublicense, as the case may be, in the [ABX]* [JTI]**
Territory 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 "ABX Territory" shall mean the United States of America and its
territories and possessions, Canada and Mexico.
1.3 "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.
1.4 "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.
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1.5 "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.
1.6 "Antibody-Secreting Cell" shall mean a cell that secretes an
Antibody, except where such cell is part of a mammal.
1.7 "[***] 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 [***], 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)
[***] as set forth in Schedule 1.
1.8 "CGI" shall mean Cell Genesys, Inc.
1.9 "Effective Date" shall mean the date this Agreement is executed by
XT and Licensee.
1.10 "Future Generation Mice" shall have the meaning defined in the
Master Research License and Option Agreement, as amended.
1.11 "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.
1.12 "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.
1.13 "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.
1.14 "JTI" shall mean Japan Tobacco Inc.
1.15 "JTI Territory" shall mean Japan, Taiwan and South Korea
(including the territory comprising North Korea if it should be reunited with
South Korea).
1.16 "License Fee" shall have the meaning set forth in Article 3
hereof.
1.17 "Licensed Field" shall mean [***].
[***] 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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1.18 "Licensed Technology" shall mean the [***] Technology, the [***]
Technology, and XT-Controlled Rights.
1.19 "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.
1.20 "Mice" shall have the meaning defined in the Master Research
License and Option Agreement, as amended.
1.21 "Net Sales" shall mean the [***] charged by Licensee or its
Affiliates and Sublicensees for sales of Product to non-Affiliate customers,
[***], with respect to such sales, and [***], as reflected in [***] of Licensee
and its Affiliates or Sublicensees, to the extent [***]. "Net Sales" for [***]
shall mean [***], where [***] shall mean the [***]. Notwithstanding the
foregoing, [***] shall include [***], but notwithstanding any of the foregoing,
shall not include [***]. Notwithstanding the foregoing, "Net Sales" for [***]
shall be [***].
1.22 "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.
1.23 "Product Antigen" shall mean ____________________.
1.24 "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
[***] 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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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.
1.25 "Territory" shall mean those countries of the world in which
Licensee has license rights pursuant to this Agreement.
1.26 "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.
1.27 "Universal Receptor Product" shall mean a substance that is
developed utilizing [***] Universal Receptor Technology.
1.28 "Universal Receptor Technology" shall mean technology for
universal receptors [***]. As used herein: (i) "universal receptor" shall mean a
receptor [***].
1.29 "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.
1.30 "[***] 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 [***] as set forth on Schedule 2.
[***] 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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1.31 "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.
1.32 "XT In-License" shall have the meaning set forth in Section 1.31,
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 [ABX]* [JTI]** Territory in the Licensed Field. Such license or sublicense
shall be exclusive even as to XT, and shall include the exclusive right to grant
and authorize sublicenses for exploitation in the [ABX]* [JTI]** Territory;
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.
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 [***].
[***] 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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4. ROYALTIES.
4.1 Royalty Rates. In consideration for the license and rights granted
herein, Licensee agrees to pay to XT royalties of [***] of Net Sales of Products
by it and its Affiliates and Sublicensees.
4.2 Royalty Offsets. In the event that (i) Licensee, its Affiliate or
Sublicensee is required to pay [***], 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, [***].
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 [***]. In the event that no such separate sales are made
in the same quarter by Licensee, Net Sales for royalty determination shall be
[***].
[***] 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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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 in accordance with this Agreement. 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 in Section 1.21 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.
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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 [***] 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 [***], 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.
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
[***] 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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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 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.
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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 [***] thus made available will be used only by Licensee
and its Affiliates and Sublicensees and manufacturing subcontractors.
8. SHARING OF CLINICAL DATA.
As long as their development projects remain on similar timelines, or
as otherwise mutually agreed, Licensee will consider bilateral sharing of its
and its Sublicensees' relevant Product development information and clinical data
with [JTI]* [ABX]**. However, there shall not be, unless otherwise agreed by the
parties, any obligation for sharing data developed independently, by or on
behalf of either of them.
9. DUE DILIGENCE.
9.1 [***].
9.1.1 Licensee agrees [***] as may be agreed upon by the parties
[***] the Effective Date.
9.1.2 Notwithstanding the foregoing, Licensee shall be [***],
shall be [***] in the United States or Japan.
9.2 Failure to Meet Due Diligence Obligation.
9.2.1 If the diligence requirements set forth in Section 9.1 are
not met by Licensee (or its Affiliates or Sublicensees) [in the United States]*
[in Japan]**, Licensee's rights hereunder shall terminate upon written notice by
XT to Licensee and subject to Sections 9.3, 9.4 and 14.3 below.
9.2.2 Notwithstanding Section 9.2.1, the license granted
hereunder to Licensee shall not terminate by reason of a delay [***], to the
extent that prudent business judgment, based on circumstances outside of
Licensee's reasonable control, reasonably justifies such delay.
[***] 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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9.3 Dispute Resolution. In the event that a dispute arises whether the
diligence requirements in Article 9 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 9.2.1.
9.4 Arbitration. In the event that the parties are unable to resolve
such dispute pursuant to Section 9.3 above, such dispute shall be settled
between XT and Licensee by binding arbitration as set forth in Section 15.12. If
the arbitrator determines that the party acted in good faith, but failed to meet
its obligations under Section 9.1 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.
10. PATENTS.
10.1 [***] 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 [***] Technology and conducting
any interferences, oppositions, reexaminations, or requesting reissues or patent
term extensions with respect to the [***] Technology. XT shall keep Licensee
reasonably informed as to the status of such patent matters in the Territory,
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 [***]
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 [***]
Technology. In such event, XT shall keep Licensee reasonably informed of the
progress of any such claim, suit or proceeding in the Territory. 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, [***].
10.2 [***] Technology.
10.2.1 XT shall 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 [***] Technology.
[***] 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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XT shall give Licensee the opportunity to review the status of all such pending
patent applications and actions in the Territory and shall keep Licensee fully
informed of the progress of such applications and actions, including, without
limitation, by promptly providing Licensee with copies of all substantive
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 XT declines or fails to prepare, file,
prosecute or maintain such patent applications or patents or take such other
actions, relating to the Products in the Territory, it shall promptly and in no
event later than ninety days prior to any filing deadline, provide notice to
Licensee. Licensee shall have the right to assume such responsibilities at its
own expense, using counsel of its choice.
10.2.2 In the event that Licensee becomes aware that any [***]
Technology is infringed or misappropriated by a third party in the Territory, or
is subject to a declaratory judgment action arising from such infringement in
such 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 the
Territory, at its expense, involving any [***] 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, [***].
10.3 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. [***], 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 impinges upon the rights of [JTI]* [ABX]**,
including without limitation, involving any admission of the invalidity of the
Licensed Technology or rights to Product Antigen outside the Territory without
the prior approval of XT.
10.4 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.
[***] 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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11. CONFIDENTIALITY.
11.1 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.
11.2 Permitted Disclosures. Notwithstanding Sections 11.1 above and
15.16 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.
12. 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 Sales of Products by any
Sublicensee. [***]. Any sublicense granted by Licensee pursuant to this
Agreement shall provide that the Sublicensee will be subject to
[***] 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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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.
13. REPRESENTATIONS AND WARRANTIES.
13.1 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.
13.2 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.
13.3 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.
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13.4 Effect of Representations and Warranties. It is understood that
if the representations and warranties under this Article 13 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.
14. TERM AND TERMINATION.
14.1 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.
14.2 Term. Unless earlier terminated pursuant to the other provisions
of this Article 14, 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.
14.3 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 15.12 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.
14.4 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.
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14.5 Effect of Termination.
14.5.1 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.
14.5.2 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.
14.5.3 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.
14.5.4 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.
14.5.5 Sections 6.3, 6.5, 6.6, 6.7 and 6.8 and Articles 11, 13,
14 and 15 shall survive the expiration and any termination of this Agreement for
any reason.
15. MISCELLANEOUS.
15.1 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.
15.2 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.
15.3 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
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Agreement shall be binding on and inure to the benefit of the permitted
successors and assigns of the parties.
15.4 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.
15.5 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.
15.6 No Implied Obligations. Except as expressly provided in Article 9
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.
15.7 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
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.
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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.
15.8 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.
15.9 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.
15.10 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.
15.11 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.
15.12 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 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
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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.
15.13 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.
15.14 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.
15.15 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.
15.16 Nondisclosure. Except as provided in Article 11, 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.
15.17 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 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.
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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.
XENOTECH, INC. (as General LICENSEE
Partner of XENOTECH, L.P.)
By: By:
----------------------------------- -------------------------------------
Name: Name:
--------------------------------- -----------------------------------
Title: Title:
-------------------------------- ----------------------------------
Schedule 1: Patents [***] Technology"
Schedule 2: Patents [***] Technology"
Schedule 3: Payments Due to Third Parties
Schedule 4: XT In-Licenses
----------
* If ABX is Licensee.
** If JTI is Licensee.
[***] 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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RESTATED EXHIBIT D
FORM OF CO-EXCLUSIVE WORLDWIDE 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 each of ABGENIX, INC., a Delaware corporation ("ABX")
and JAPAN TOBACCO INC., a Japanese corporation ("JTI").
RECITALS
A. XT desires to grant JTI an exclusive license in the JTI Territory under the
Licensed Technology to commercialize Products, and JTI wishes to acquire such a
license, on the terms and conditions herein.
B. XT desires to grant ABX an exclusive license in the ABX Territory under the
Licensed Technology to commercialize Products, and ABX wishes to acquire such a
license, on the terms and conditions herein.
C. XT desires to grant to JTI and ABX a co-exclusive license in the Rest of the
World under the Licensed Technology to commercialize Products, and JTI and ABX
wish to acquire such license, 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 "ABX Territory" shall mean the United States of America and its
territories and possessions, Canada and Mexico.
1.3 "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.
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1.4 "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.
1.5 "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.
1.6 "Antibody-Secreting Cell" shall mean a cell that secretes an
Antibody, except where such cell is part of a mammal.
1.7 "[***] 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 [***], 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)
[***] as set forth in Schedule 1.
1.8 "CGI" shall mean Cell Genesys, Inc.
1.9 "Effective Date" shall mean the date this Agreement is executed by
XT, CGI and JTI.
1.10 "Future Generation Mice" shall have the meaning defined in the
Master Research License and Option Agreement, as amended.
1.11 "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.
1.12 "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.
1.13 "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.
1.14 "JTI" shall mean Japan Tobacco Inc.
1.15 "JTI Territory" shall mean Japan, Taiwan and South Korea
(including the territory comprising North Korea if it should be reunited with
South Korea).
[***] 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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1.16 "License Fee" shall have the meaning set forth in Article 3
hereof.
1.17 "Licensed Field" shall mean [***].
1.18 "Licensed Technology" shall mean the [***] Technology, the [***]
Technology, and XT-Controlled Rights.
1.19 "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.
1.20 "Mice" shall have the meaning defined in the Master Research
License and Option Agreement, as amended.
1.21 "Net Sales" shall mean the [***] charged by ABX or JTI, as the
case may be, or its Affiliates and Sublicensees for sales of Product to
non-Affiliate customers, [***], with respect to such sales, and [***], as
reflected in [***] of ABX or JTI and its Affiliates or Sublicensees, to the
extent [***]. "Net Sales" for [***] shall mean [***], where [***] shall mean the
[***]. Notwithstanding the foregoing, [***] shall include [***]. Notwithstanding
the foregoing, "Net Sales" for [***] shall be [***].
1.22 "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.
1.23 "Product Antigen" shall mean ____________________.
[***] 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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1.24 "Rest of the World" shall mean all parts of the world not
included in ABX Territory or the JTI Territory.
1.25 "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 ABX or JTI, as the case may be, has granted a
sublicense under the Licensed Technology to make, use and/or sell Products to
the extent of the rights of ABX or JTI, as the case may be, therein.
"Sublicensee" shall also include a third party to whom ABX or JTI has granted
the right to distribute Products under the Licensed Technology to the extent of
the rights of ABX or JTI, as the case may be, therein, provided that such third
party is responsible for the marketing and promotion of Products within the
applicable country.
1.26 "Territory" shall mean those countries of the world in which ABX
or JTI, as the case may be, has exclusive or co-exclusive license rights
pursuant to this Agreement.
1.27 "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.
1.28 "Universal Receptor Product" shall mean a substance that is
developed utilizing [***] Universal Receptor Technology.
1.29 "Universal Receptor Technology" shall mean technology for
universal receptors or [***]. As used herein: (i) "universal receptor" shall
mean a receptor [***].
1.30 "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.
[***] 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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1.31 "[***] 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 [***] as set forth on Schedule 2.
1.32 "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.
1.33 "XT In-License" shall have the meaning set forth in Section 1.32,
above.
2. LICENSE GRANT; USE OF MICE BY THIRD PARTIES.
2.1 Grant to ABX. Subject to the terms and conditions of this
Agreement, XT hereby grants to ABX 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 ABX Territory in the Licensed Field. Such license or
sublicense shall be exclusive even as to XT, and shall include the exclusive
right to grant and authorize sublicenses for exploitation within the ABX
Territory; provided, however, that ABX may not, under this license, grant
sublicenses to any rights to the Mice except as provided in Section 2.4 of this
Agreement.
2.2 Grant to JTI. Subject to the terms and conditions of this
Agreement, XT hereby grants to JTI 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 JTI Territory in the Licensed Field. Such license or
sublicense shall be exclusive even as to XT, and shall include the exclusive
right to grant and authorize sublicenses for exploitation within the JTI
Territory; provided, however, that JTI may not, under this license, grant
sublicenses to any rights to the Mice except as provided in Section 2.4 of this
Agreement.
2.3 Rest of the World. Subject to the terms and conditions of this
Agreement, XT hereby grants to each ABX and JTI a co-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 Rest of the World in the Licensed Field.
Such co-exclusive license or sublicense shall be co-exclusive even as to XT, and
shall include the co-exclusive right to grant and authorize sublicenses for
exploitation within the Rest of the World; provided, however, that ABX and JTI
may not, under this license, grant sublicenses to any rights to the Mice except
as provided in Section 2.4 of this Agreement.
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2.4 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, ABX or JTI, as the case may be, 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 2.4 shall not exceed the Licensee's (ABX or JTI, as the case may be,)
rights conferred in accordance with the Master Research License and Option
Agreement or this Product License.
2.5 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.
ABX and JTI each shall pay to XT within thirty days of the Effective Date a
license fee of [***].
4. ROYALTIES.
4.1 Royalty Rates. In consideration for the license and rights granted
herein, ABX and JTI each agree to pay to XT royalties of [***] of Net Sales of
Products by it and its Affiliates and Sublicensees.
4.2 Royalty Offsets. In the event that (i) a Licensee (ABX or JTI, as
the case may be), its Affiliate or Sublicensee is required to pay [***], or (ii)
any reimbursement payments are due to XT pursuant to Section 5.1 below, then ABX
or JTI, as the case may be, 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 ABX or JTI, as the case may be,
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.
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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 ABX or
JTI, as the case may be, 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, [***].
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 [***]. In the event that no such separate sales are made
in the same quarter by ABX or JTI, as the case may be, Net Sales for royalty
determination shall be [***].
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. ABX and/or JTI, as the case may
be, 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 in accordance with
this Agreement. ABX and/or JTI 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 ABX and/or
JTI, as the case may be, to make any payments under this Section 5.1 without the
prior written consent of ABX and/or JTI, as the case may be..
5.2 Royalties Payable by ABX or JTI. Xenotech shall have no
responsibility under the terms of this Agreement for the payment of any
royalties, license fees or milestone or other
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payments due to third parties under licenses or similar agreements entered into
by ABX or JTI, as the case may be, 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, ABX or JTI each 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, ABX or JTI, as the case may be, 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 in Section 1.21
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 ABX or JTI as the case may be, and such licensee
shall provide the reports and payments set forth in Section 6.1 above not later
than ten (10) 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 ABX or JTI with
an invoice by facsimile setting forth the royalties XT must pay third parties
with respect to such licensee's activities in its Territory in the preceding
quarter, and such licensee shall pay such invoices within thirty days of receipt
of such invoice.
6.3 Records; Inspection. ABX and JTI shall each 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 ABX and JTI 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 each 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. ABX and JTI shall each
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 such 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 the particular 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 of ABX or JTI, as the
case may be, producing an increase exceeding [***] 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 such 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 ABX and JTI, as the case may be, shall be released from any
liability or accountability with respect to royalties for such year.
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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 [***], 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.
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.
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6.8 XT Tax Indemnity. XT shall indemnify and hold harmless ABX and JTI
and their Affiliates from and against any increase to their respective 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 ABX or JTI 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 their respective
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 ABX's or JTI's, as the case may be, or its Affiliates' taxable
income in a foreign state (which may include, for example invoking competent
authority 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. ABX and JTI shall each independently furnish
and be responsible for funding and conducting all of its preclinical and
clinical research and development of Products, at its own expense.
8. SHARING OF CLINICAL DATA
As long as their development projects remain on similar timelines, or
as otherwise mutually agreed, ABX and JTI will consider bilateral sharing of
their and their Sublicensees' relevant Product development information and
clinical data. However, there shall not be, unless otherwise agreed upon by the
parties, any obligation for sharing data developed independently, by or on
behalf of either of them.
9. DUE DILIGENCE.
9.1 [***].
9.1.1 ABX and JTI, as the case may be, agree to [***] as may be
agreed upon by the parties [***] the Effective Date.
9.1.2 Notwithstanding the foregoing, each of ABX and JTI shall be
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[***]. After [***], shall each be [***] in the United States or Japan.
9.2 Failure to Meet Due Diligence Obligation.
9.2.1 If the diligence requirements set forth in Section 9.1 are
not met by ABX (or its Affiliates or Sublicensees) in the United States or by
JTI (or its Affiliates or Sublicensees) in Japan, such licensee's rights
hereunder shall terminate upon written notice by XT to such licensee and subject
to Sections 9.3, 9.4 and 14.3 below.
9.2.2 Notwithstanding Section 9.2.1, the license granted
hereunder to ABX or JTI, as the case may be, shall not terminate by reason of a
delay [***], to the extent that prudent business judgment, based on
circumstances outside of such licensee's reasonable control, reasonably
justifies such delay.
9.3 Dispute Resolution. In the event that a dispute arises whether the
diligence requirements in Article 9 have been met or circumstances exist which
ABX or JTI, respectively, believes justifies a failure on its part to meet such
obligation, the parties will attempt to resolve any dispute by mutual agreement
and, if required, the Chief Executive Officer of ABX and the Vice President of
the Pharmaceutical Division of JTI shall meet personally and negotiate in good
faith to resolve such dispute during a period of thirty days following
licensee's receipt of the notice under Section 9.2.1.
9.4 Arbitration. In the event that the parties are unable to resolve
such dispute pursuant to Section 9.3 above, such dispute shall be settled
between XT and the other party by binding arbitration as set forth in Section
15.12. If the arbitrator determines that the party acted in good faith, but
failed to meet its obligations under Section 9.1 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.
10. PATENTS.
10.1 [***] 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 [***] Technology and conducting
any interferences, oppositions, reexaminations, or requesting reissues or patent
term extensions with respect to the [***] Technology. XT shall keep ABX and JTI
each reasonably informed as to the status of such patent matters in its
Territory, including without limitation, by providing such licensee the
opportunity to review and comment on any substantive documents which will be
filed in any patent office, and providing such licensee copies of any
substantive documents received by XT from such patent offices including
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notice of all interferences, reexaminations, oppositions or requests for patent
term extensions. ABX and JTI shall cooperate with and assist XT in connection
with such activities, at XT's request and expense.
(b) In the event that either ABX or JTI, as the case may be,
becomes aware that any [***] Technology necessary for the practice of the
licenses granted herein is infringed or misappropriated by a third party or is
subject to a declaratory judgment action arising from such infringement, such
party shall promptly notify XT (and the other licensee) 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 [***] Technology. In
such event, XT shall keep ABX and/or JTI, as the case may be, reasonably
informed of the progress of any such claim, suit or proceeding in its Territory.
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,
[***].
10.2 [***] Technology.
10.2.1 XT shall 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 [***] Technology. XT shall
give ABX and JTI each the opportunity to review the status of all such pending
patent applications and actions in its Territory and shall keep ABX and/or JTI,
as the case may be, fully informed of the progress of such applications and
actions, including, without limitation, by promptly providing ABX and/or JTI
with copies of all substantive correspondence sent to and received from patent
offices, and providing notice of all interferences, reexaminations, oppositions
or requests for patent term extensions. [***]. If only either ABX or JTI should
be a licensee under this Agreement, such expenses shall be equally divided
between XT and such Licensee on a worldwide basis. In the event that XT declines
or fails to prepare, file, prosecute or maintain such patent applications or
patents or take such other actions, relating to the Products it shall promptly
and in no event later than ninety days prior to any filing deadline, provide
notice to ABX and JTI. ABX and JTI shall promptly discuss and agree on who
should assume such responsibilities and how the expenses related thereto should
be allocated.
10.2.2 In the event that a licensee becomes aware that any [***]
Technology necessary for the practice of the license granted herein is infringed
or misappropriated by a third party in any country in which ABX or JTI has
rights hereunder, or is subject to a declaratory judgment action arising from
such infringement in such country, ABX or JTI, as the case may be, shall
promptly notify XT and XT shall thereafter promptly notify the owner of such
intellectual property.
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10.2.3 ABX or JTI, as the case may be, shall have the exclusive
right to enforce, or defend any declaratory judgment action, in any country in
which it has exclusive rights hereunder, at its expense, involving [***]
Technology. In such event, the party involved in such claim , suit or
proceeding, shall keep XT and the other of ABX or JTI reasonably informed of the
progress of any such claim, suit or proceeding. Any recovery by such party
received as a result of any such claim, suit or proceeding shall be used first
to reimburse such party for all expenses (including attorneys, and professional
fees) incurred in connection with such claim, suit or proceeding, and [***].
10.2.4 ABX and JTI shall consult and agree whether, and if so,
how, to enforce the [***] Technology in a country in which ABX and JTI have
co-exclusive rights hereunder. However, [***] (except as otherwise provided
below). The party taking such action shall keep XT and the other of ABX or JTI
reasonably informed of the progress of any such claim, suit or proceeding. Any
recovery by such party received as a result of any such claim, suit or
proceeding shall be used first to reimburse such party for all expenses
(including attorneys' and professional fees) incurred in connection with such
claim, suit or proceeding, [***].
10.3 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 ABX or JTI (or their respective Affiliates or
Sublicensees), ABX or JTI, as the case may be, shall promptly notify XT thereof
in writing setting forth the facts of such claim in reasonable detail. [***],
ABX or JTI, as the case may be, 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. Such parties 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. The other of ABX or JTI may
participate in the defense of any such claim, suit or proceeding at its own
expense through counsel of its choice. ABX or JTI, as the case may be, [***]
pursuant to this Agreement. Notwithstanding the above, neither ABX nor JTI shall
be able to settle any such claim, suit or proceeding that impinges upon the
rights of ABX or JTI, as the case may be, including, without limitation,
involving any admission of the invalidity of the Licensed Technology or rights
to Product Antigen outside its Territory without the prior approval of XT.
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10.4 Patent Marking. ABX and JTI agree 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.
11. CONFIDENTIALITY.
11.1 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.
11.2 Permitted Disclosures. Notwithstanding Sections 11.1 above and
15.16 below, each party hereto may disclose another 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 ABX
or JTI except as agreed in writing by such party.
12. SUBLICENSES.
Pursuant to Article 2 herein, ABX and JTI shall each have the
exclusive right in the ABX Territory and JTI Territory, respectively, and the
co-exclusive right in the Rest of the World to
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grant and authorize sublicenses to third parties; provided, however, such party
shall remain responsible for any payments due XT for Net Sales of Products by
any Sublicensee. [***]. Any sublicense granted by ABX or JTI pursuant to this
Agreement shall provide that the Sublicensee will be subject to the applicable
terms of this Agreement. ABX or JTI, as the case may be, shall provide XT with a
copy of relevant portions of each sublicense agreement, as reasonably required
by XT.
13. REPRESENTATIONS AND WARRANTIES.
13.1 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 ABX and JTI
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 ABX
and/or JTI 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.
13.2 ABX and JTI. Each of ABX and JTI 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 it 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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13.3 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.
13.4 Effect of Representations and Warranties. It is understood that
if the representations and warranties under this Article 13 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.
14. TERM AND TERMINATION.
14.1 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.
14.2 Term. Unless earlier terminated pursuant to the other provisions
of this Article 14, 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.
14.3 Termination for Breach. Any party to this Agreement may terminate
this Agreement as to another party hereto in the event such 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 15.12 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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14.4 Other Termination Rights. ABX or JTI may terminate this Agreement
and the license granted to such party 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 that apply to
the terminating party.
14.5 Effect of Termination.
14.5.1 In the event that this Agreement (i) is terminated under
Section 14.3 above, by reason of a breach by ABX or JTI, this Agreement shall
terminate with respect to the breaching party only, and shall continue in effect
with respect to XT and the non-breaching party; (ii) is terminated by ABX or JTI
by reason of a breach by XT, this Agreement shall terminate as to XT and the
terminating party, and shall continue in effect with respect to XT and the other
of ABX and JTI; or (iii) is terminated by ABX or JTI under Section 14.4 above,
this Agreement shall terminate with respect to the party exercising its right to
terminate thereunder, and shall continue in effect in its entirety with respect
to XT and the non-terminating party. In each case, the non-breaching or non-
terminating licensee shall thereupon have the right to obtain an exclusive
license or sublicense, as the case may be, under the Licensed Technology, to
make and have made Product for use, sale or other distribution in the Licensed
Field throughout the world, on the terms and conditions set forth herein that
are applicable to it.
14.5.2 Termination of this Agreement for any reason shall not
release any 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.
14.5.3 In the event this Agreement is terminated with respect to
ABX or JTI for any reason, such 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 a 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.
14.5.4 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.
14.5.5 This Agreement, including the licenses 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.
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14.5.6 Sections 6.3, 6.5, 6.6, 6.7 and 6.8 and Articles 11, 13,
14 and 15 shall survive the expiration and any termination of this Agreement for
any reason.
15. MISCELLANEOUS.
15.1 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.
15.2 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.
15.3 Assignment. This Agreement and the licenses granted hereunder may
not be assigned by ABX or JTI 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
both ABX and JTI; 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.
15.4 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.
15.5 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.
15.6 No Implied Obligations. Except as expressly provided in Article 9
above, nothing in this Agreement shall be deemed to require ABX or JTI to
exploit the Licensed Technology nor to prevent ABX or JTI from commercializing
products similar to or competitive with any Products, in addition to or in lieu
of such Products.
15.7 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
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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
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.
15.8 Export Laws. Notwithstanding anything to the contrary contained
herein, all obligations of XT, ABX and JTI 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. ABX and JTI each shall use efforts consistent with
prudent business judgment to obtain such approvals. XT shall cooperate with ABX
and JTI and shall provide assistance to them as reasonably necessary to obtain
any required approvals.
15.9 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.
15.10 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
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reason where failure to perform, is beyond the reasonable control and not caused
by the negligence, intentional conduct or misconduct of the nonperforming party.
15.11 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.
15.12 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 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
unless initiated by XT or ABX against JTI, in which event it will be held in
Tokyo, Japan. 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.
15.13 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. 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, ABX and JTI.
15.14 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.
15.15 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.
15.16 Nondisclosure. Except as provided in Article 11, 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
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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.
15.17 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 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 in triplicate
originals, through their respective officers hereunto duly authorized, as of the
day and year first above written.
JAPAN TOBACCO INC. ABGENIX, INC.
By: By:
---------------------------------- -------------------------------------
Name: Name:
-------------------------------- -----------------------------------
Title: Title:
------------------------------- ----------------------------------
XENOTECH, INC. (as General Partner of
XENOTECH, L.P.)
By:
----------------------------------
Name:
--------------------------------
Title:
-------------------------------
Schedule 1: Patents [***] Technology"
Schedule 2: Patents [***] Technology"
Schedule 3: Payments Due to Third Parties
Schedule 4: XT In-Licenses
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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EXHIBIT H
XENOTECH CONTROLLED RIGHTS
[***]
[***] 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.
