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").
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.
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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(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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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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respect to the omitted portions.
(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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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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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.
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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[***]. 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
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respect to the omitted portions.
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.
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 Gr ...
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