Exhibit 10.31B
SECOND AMENDMENT TO COLLABORATION
AGREEMENT
This Second Amendment to
Collaboration Agreement (this “ Second Amendment
”) is effective as of February 9, 2009 (the “
Amendment Effective Date ”) and is made by and among
Takeda Pharmaceutical Company Limited, a Japanese corporation
having offices at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645,
Japan (hereinafter “ Takeda ”); XOMA (US) LLC, a
Delaware limited liability company having offices at 2910 Seventh
Street, Berkeley, California 94710, USA (hereinafter “
XOMA ”) [*]
BACKGROUND
A. XOMA and Takeda entered into a
certain Collaboration Agreement dated as of November 1, 2006
(as amended, including by the First Amendment and, unless otherwise
noted after giving effect to this Second Amendment, the “
Agreement ”).
B. As part of the Collaboration,
Takeda has expressed a desire to obtain (i) expanded rights to
XOMA-Controlled intellectual property rights and (ii) certain
materials and related information, hereinafter identified as,
inter alia [*] the Discovery Know-How and the
Systems.
C. XOMA and Takeda wish to amend the
Agreement and expand the Collaboration, and to further enable
Takeda to work with XOMA, the XOMA Companies wish to license,
sublicense, and otherwise make available certain items of
intellectual property and deliver to Takeda and, where specified
herein, assign to Takeda (and its Affiliates) all right, title and
interest in, the Transferred Materials as specified
herein.
D. Takeda, on its own behalf and on
behalf of its Affiliates, agrees to accept the Transferred
Materials under the terms and conditions of this Second Amendment
and, as applicable, the Agreement.
E. The XOMA Companies will benefit
from the transactions contemplated by this Second Amendment and the
Agreement, and are willing to (i) grant Takeda the expanded
rights and licenses contained in this Second Amendment [*] and
Takeda agrees to accept such grants [*]
F. Terms which are defined in the
Agreement shall have the same meanings when used in this Second
Amendment, unless a different definition is given
herein.
NOW, THEREFORE, in consideration of
the premises and of the mutual covenants and agreements contained
herein, each of the XOMA Companies and Takeda agree as
follows:
Section 1. Amendments .
Pursuant to Section 14.9 of the Agreement,
(a) Article 1 (Definitions) of the Agreement is
hereby supplemented, amended and modified with the following
definitions:
1.3 “ Affiliate ”
means, as of the Amendment Effective Date, as to a particular
person or entity, any corporation, company, partnership, joint
venture and/or firm that controls, is controlled by or is under
common control with such person or entity. For purposes hereof,
“control” means (a) in the case of a corporate
entity, direct or indirect ownership of more than fifty
percent
(50%) of the stock or shares
entitled to vote for the election of directors; (b) in the
case of a non-corporate entity, direct or indirect ownership of
more than fifty percent (50%) of the equity interests with the
power to direct the management and policies of such non-corporate
entity; or (c) possession, directly or indirectly, of the
power to direct or cause the direction of the management or
policies of the entity in question (whether through ownership of
securities or other ownership interests, by contract or
otherwise).
1.8A “ Applicable
Specifications ” means (a) with respect to [*] the
[*] Materials Specifications, (b) with respect to [*] the
specifications determined to be applicable thereto in accordance
with Section 3A.4(a), and (c) with respect to each of the
Systems, the specifications corresponding to such System set forth
in Schedule 1.8A.
1.8B “ Article 3A
Know-How ” means, collectively, the Discovery Know-How,
HE™ Know-How [*] TES Know-How, and Systems
Know-How.
1.8C “ Article 3A Patent
Rights ” means, collectively, the Discovery Patent
Rights, HE™ Patent Rights [*] TES Patent Rights, and Systems
Patent Rights.
1.8D “ Bacterial Cell
Expression Technology ” or “ BCE Technology
” means (a) the Patent Rights listed on Schedule 1.8D
(the “ BCE Patent Rights ”) [*] BCE Patent
Rights shall be deemed to exclude any and all Article 3A Patent
Rights, except that the Patent Rights titled [*] and more
particularly described on Schedule 1.29C as of the Amendment
Effective Date shall be deemed to be both BCE Patent Rights and
Discovery Patent Rights.
1.11A “ BCE 6A.2 License
Term ” means that duration of time beginning on the
Amendment Effective Date and ending upon the termination of the
license granted under Section 6A.2 pursuant to
Section 13.5A.
1.11B “ BCE 6A.6 License
Term ” means that duration of time beginning on the
Amendment Effective Date and ending upon the termination of the
license granted under Section 6A.6 pursuant to
Section 13.5A.
1.11C “ BCE Patent
Rights ” has the meaning specified in Section 1.8D
hereof.
1.17A “ Claims ”
has the meaning specified in Section 12.4A hereof.
1.20 “ Collaboration
Product ”, as of the Amendment Effective Date, is amended
to add the following sentence: “No Discovery Product shall be
considered a Collaboration Product.”
1.24 “ Confidential
Information ”, as of the Amendment Effective Date, is
amended to add the following sentence: “[*] shall not be
considered to be Confidential Information of
XOMA.”
1.27 “ Control ”
or “ Controlled ” means, as of the Amendment
Effective Date, with respect to any (a) material, document,
item of information, method, data or other Know-How or
(b) Patent Right or other intellectual property right, the
possession (whether by ownership, license, covenant not to sue or
otherwise, other than by a license granted pursuant to this
Agreement) by a Party or its Affiliates of the ability to grant to
the other Party access, ownership, a license, a sublicense and/or a
covenant not to sue or otherwise (as provided herein) under such
item or right without violating the terms of any agreement or other
arrangement with any Third Party as of the time such Party would
first be required hereunder to grant the other Party such access,
ownership, license or sublicense.
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1.28A “ CRO ”
means any contract research organization [*] engaged in contract
research on behalf of Takeda or a Designated Takeda Affiliate using
Transferred Materials and any provider of storage services to
Takeda or a Designated Takeda Affiliate with respect to
[*]
1.28B [*]
1.28C [*]
1.28D “ Designated Takeda
Affiliate ” means Takeda SF or any other Takeda Affiliate
designated by Takeda to XOMA in accordance with
Section 3A.5(a).
1.29A “ Discovery
Know-How ” means the Know-How required to be transferred
to Takeda or its Affiliates pursuant to Sections 3A.1 and
3A.4.
1.29B [*]
1.29C “ Discovery Patent
Rights ” means the Patent Rights described on Schedule
1.29C, [*]. Discovery Patent Rights shall be deemed to exclude any
and all BCE Patent Rights, except that the Patent Rights titled [*]
and more particularly described on Schedule 1.29C as of the
Amendment Effective Date shall be deemed to be both BCE Patent
Rights and Discovery Patent Rights.
1.29D [*]
1.29E “ Discovery
Product ” means an Antibody, Antibody Product or other
therapeutic, prophylactic or diagnostic compound or product [*]
and/or the practice of the Discovery Patent Rights or other
exercise of its rights under this Second Amendment.
1.29F “ Discovery Product
Royalty Period ” has the meaning specified in
Section 7A.1(d) hereof.
1.45 “ GAAP ”
means, as of the Amendment Effective Date, for each applicable
country or territory, the generally accepted accounting principles
for such country or territory, as they exist from time to time,
consistently applied.
1.45A “ HE™
Know-How ” has the meaning specified in Section 1.46
hereof.
1.45B “ HE™ License
Term ” means that duration of time beginning on the
Amendment Effective Date and ending upon the termination of the
license granted under Section 6A.5 pursuant to
Section 13.5A.
1.45C “ HE™ Patent
Rights ” has the meaning specified in Section 1.46
hereof.
1.46 “ Human
Engineering™ Technology ”, as of the Amendment
Effective Date, is amended to read in its entirety as follows:
“‘ Human Engineering™ Technology ’
or ‘ HE™ Technology ’ means (a) the
materials and Know-How (the “HE™ Know-How”) and
Patent Rights (the “ HE™ Patent Rights ”)
listed on Schedule 1.46 [*]”
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1.49A [*]
1.57A “ Licensed
Technology ” means the BCE Technology, HE™
Technology [*] TES Technology, and Systems.
1.61A [*]
1.71 “ Program Antibody
”, as of the Amendment Effective Date, is amended to insert
the number “(1)” after the words “provided,
however, that” and add the following clause to the end of the
last sentence: “and (2) in no event shall the term
“Program Antibody” include any Discovery
Product.”
1.75 “ Program
Technology ”, as of the Amendment Effective Date, is
amended to insert the words “, Licensed Technology and
[*]” at the end of the last sentence.
1.87A “ Royalty-Bearing
Discovery Product ” means a Royalty-Bearing Discovery
Product A or Royalty Bearing Discovery Product B.
1.87B “ Royalty-Bearing
Discovery Product A ” means [*] provided, however, an
Antibody Product that is both a Royalty-Bearing Discovery Product A
and Royalty-Bearing Discovery Product B shall be deemed only to be
a Royalty Bearing Discovery Product A.
1.87C “ Royalty-Bearing
Discovery Product B ” means [*]
1.87D “ Second Amendment
Indemnitee ” has the meaning specified in
Section 12.4D(b) hereof.
1.87E “ Second Amendment
Indemnitor ” has the meaning specified in
Section 12.4D(b) hereof.
1.87F “ Second Amendment
Milestone Payment ” has the meaning specified in
Section 7A.1(c) hereof.
1.87G “ Software
” has the meaning specified in Schedule 6A.3 to the Second
Amendment.
1.87H “ Source Code
” has the meaning specified in Schedule 6A.3 to the Second
Amendment.
1.87I [*]
1.88A [*]
1.88B [*].
1.89A “ Systems ”
means the informatics and other materials handling systems,
associated software applications, related data systems, Patent
Rights related to the foregoing (the “ Systems Patent
Rights ”) and related Know-How (the “ Systems
Know-How ”), each as more particularly described on
Schedule 1.89A. For the purposes of the Agreement, Systems shall
not include any Third Party software, operating system, data device
or other materials not part of, or actually integrated into, the
Systems as delivered to Takeda.
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1.89B “ Systems
Know-How ” has the meaning specified in
Section 1.89A hereof.
1.89C “ Systems License
Term ” means that duration of time beginning on the
Amendment Effective Date and ending upon the termination of the
license granted under Section 6A.3 pursuant to
Section 13.5A.
1.89D “ Systems Patent
Rights ” has the meaning specified in Section 1.89A
hereof.
1.89E [*]
1.89F [*]
1.89G [*]
1.90A “ Takeda Discovery
Patent Rights ” means Patent Rights to the extent
Controlled by Takeda that arise out of Takeda’s or a
Designated Takeda Affiliate’s use or practice of the
Discovery Patent Rights or Licensed Technology.
1.90B “ Takeda Licensee
” means, solely with respect to Discovery Products, any Third
Party to whom Takeda or a Designated Takeda Affiliate licenses or
grants rights, as part of a bona fide collaboration, development,
commercialization or marketing arrangement, to develop,
commercialize, market or distribute any Discovery Product;
provided , however , no Third Party shall be a Takeda
Licensee if (a) such Third Party is known by Takeda to be, at
the time of determination, either misappropriating the Article 3A
Know-How or infringing any of the Article 3A Patent Rights or
(b) such Takeda Licensee does not take material economic risk
with respect to the discovery, identification, development or
commercialization of such Discovery Product that is the subject of
the applicable arrangement; and provided , further ,
that the foregoing clause (b) shall not prevent Takeda from
using any Third Party as a distributor or selling agent of such
Discovery Products. All arrangements with a Takeda Licensee related
to Discovery Products shall be pursuant to a written agreement,
which will incorporate the applicable provisions of the Agreement
(including without limitation Article 3A) and, where applicable,
provide that XOMA and its Affiliates shall be third party
beneficiaries thereof.
1.90C “ Takeda San
Francisco ” or “ Takeda SF ” means
Takeda San Francisco, Inc., a Delaware corporation having offices
at 285 East Grand Avenue, South San Francisco, California 94080,
USA, as of the Amendment Effective Date.
1.91A [*]
1.92A “ TES Know-How
” has the meaning specified in Section 1.93C
hereof.
1.92B “ TES License
Term ” means that duration of time beginning on the
Amendment Effective Date and ending upon the termination of the
license granted under Section 6A.4 pursuant to
Section 13.5A.
1.92C “ TES Patent
Rights ” has the meaning specified in Section 1.93C
hereof.
1.93A [*]
1.93B “ Transferred
Materials ” means, collectively [*] the Article 3A
Know-How, the Systems and any materials actually transferred to
Takeda pursuant to Article 3A.
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1.93C “ Transient
Expression System Technology ” or “ TES
Technology ” means (a) the materials and Know-How
(the “ TES Know-How ”) and the Patent Rights
(the “ TES Patent Rights ”), listed on Schedule
1.93C [*]
1.95A “ XOMA Collaboration
Partner ” means, solely with respect to a Third Party
with whom XOMA licenses or grants rights, as part of a bona fide
collaboration, development, commercialization or marketing
arrangement, to develop, commercialize, market or distribute any
compound or product; provided, however, no Third Party shall be a
Collaboration Partner if (a) such Third Party is known by XOMA
to be, at the time of determination, either misappropriating any
Takeda Know-How or infringing any Takeda Discovery Patent Rights or
(b) such Collaboration Partner does not take material economic
risk with respect to the discovery, identification, development or
commercialization of such compound or product that is the subject
of the applicable arrangement; and provided , further
, that the foregoing clause (b) shall not prevent XOMA from
using any Third Party as a distributor or selling agent of such
compounds or products.
1.95B [*]
1.95C “[*] Materials
Specifications ” means the specifications listed on
Schedule 1.95B.
(b) The Agreement is hereby supplemented by adding
the following Article 3A following existing Article 3:
ARTICLE 3A
XOMA TO TAKEDA
TRANSFERS
3A.1 Assignments and
Deliverables .
(a) XOMA shall on behalf of itself
and each XOMA Company, and as evidenced by a Bill of Sale in the
form attached as Exhibit A , assign and transfer to Takeda
all right, title and interest, free and clear of all liens,
security interests and statutory encumbrances, (i) upon
satisfaction by XOMA or waiver by Takeda of the conditions to
payment set forth in Section 4 of this Second Amendment, to
[*] and (ii) upon satisfaction of either condition under
Sections 3A.4(c)(ii)(x) or (y), to [*]
(b) On or before [*] after the
Amendment Effective Date, XOMA shall deliver to Takeda (i) [*]
the Discovery Know-How relating thereto, including all materials
listed on Schedule 3A.1(a) , the HE™ Know-How [*] the
TES Know-How and the Systems as evidenced by the Delivery and
Receipt Acknowledgement in the form attached as Exhibit B
[*]
(c) [*]
(d) In connection with [*] and
Licensed Technology other than BCE Technology, XOMA shall provide
Takeda with the corresponding services described in and under the
terms of Schedule 3A.1(d) .
(e) Risk of loss or degradation to
and of Transferred Materials shall shift to Takeda upon
Takeda’s signed confirmation of receipt of such
materials.
(f) [*]
3A.2 Grants of Rights in
Discovery Know-How and Patent Rights [*]
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(a) [*] XOMA on behalf of itself and
each XOMA Company does hereby grant to Takeda, a sole and
exclusive, irrevocable, perpetual and, subject to the applicable
restrictions and limitations in this Second Amendment, assignable
license and right throughout the Territory to use [*] for any and
all purposes including to [*] modify and develop Discovery
Products; and
(b) Without limiting the licenses
granted under Article 6A, XOMA on behalf of itself and each XOMA
Company does hereby grant to Takeda a non-exclusive,
non-transferable, license and right throughout the Territory,
without the right to grant sublicenses to:
(x) use the Discovery Know-How, and
practice the Discovery Patent Rights, in each case at a Takeda or
Designated Takeda Affiliate to [*] modify and develop Discovery
Products;
(y) use the BCE Technology in
connection with the use of [*] for any and all purposes including
to [*] modify and develop Discovery Products, but not to [*] any
quantities of any compound or product, including an Antibody, in a
prokaryote except as reasonably necessary to conduct non-clinical
research and development activities using [*] including in vitro
and small animal in vivo research and development, and not for
clinical development or for the manufacture for sale of any
compound or product, including an Antibody; and
(z) to the extent required (if any),
use the Discovery Know-How, and practice the Discovery Patent
Rights to [*] use, sell, offer to sell, import or export any
Discovery Product.
Notwithstanding any provision of
this Second Amendment to the contrary, the rights and licenses
provided for in this Section 3A.2 include, to the extent
required, a right and license to Takeda and its Affiliates, [*] to
develop, commercialize, market or distribute [*] or the practice of
the other Article 3A Patent Rights.
[*] the rights and licenses granted
under Articles 3A and 6A in this Second Amendment shall be subject
to those limitations, restrictions and obligations of any license
or grant of rights from or other agreement with a Third Party which
Third Party limitations, restrictions and obligations are disclosed
to Takeda on, or were disclosed to Takeda prior to, the Amendment
Effective Date.
(c) Each of the XOMA Companies
hereby covenants that it shall not initiate or permit any of its
Affiliates or any Third Party over whom it has control to initiate
or knowingly assist in any way in the initiation or prosecution of,
any action against Takeda, any Takeda Affiliates, its and their
employees, directors, officers or agents, any Takeda Licensee or
CRO authorized hereunder, including Takeda’s distributors and
selling agents, for the misappropriation, infringement or other
violation of any Patent Rights, Know-How or other intellectual
property rights directly or indirectly owned or controlled by such
XOMA Company at any time that, if owned or controlled by XOMA as of
the Amendment Effective Date [*] would have been within the scope
of the licenses granted to Takeda under Section 3A.2(b) or
Article 6A.
(d) In the event that XOMA is or
becomes unable to grant Takeda, or any Designated Takeda Affiliate,
any of the rights described under subsections 3A.2(a) or (b), and
to the extent that a XOMA Affiliate, including [*] has the
necessary right, power and authority to grant Takeda, or any
Designated Takeda Affiliate, such rights, the applicable XOMA
Affiliate hereby grants to Takeda, or a Designated Takeda
Affiliate, such rights to the extent and under the terms contained
herein.
(e) [*]
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(f) [*] If as part of the
Collaboration, Takeda submits a Proposed Target and specifically
requests that XOMA use [*] to [*] an Antibody and XOMA agrees to do
so, then such Proposed Target shall be subject to the XOMA
gate-keeping process under Section 2.2.3.
(g) None of XOMA or its Affiliates
shall (except for the sole benefit of Takeda and its Affiliates)
(i) [*] (ii) [*] or (iii) without Takeda’s
prior written consent, transfer [*] to any person or entity (other
than Takeda or a Designated Takeda Affiliate), except in
conjunction with an assignment of this Agreement under
Section 14.2. Notwithstanding the foregoing, XOMA may retain a
sufficient quantity of [*] in storage solely for the purposes of
[*]
(h) The Parties agree that XOMA may
use “blinded” validation and qualification data
regarding [*] (so long as such use does not jeopardize the
patentability of any invention claimed by a patent or patent
application filed by Takeda) for purposes of demonstrating,
presenting or otherwise promoting its technologies, expertise,
capabilities and/or applications of any thereof. XOMA shall submit
such blinded data to Takeda for approval at least [*] prior to
disclosure, such approval not to be unreasonably withheld or
delayed. Once the presentation of such data in a particular form
has been approved by Takeda, no further approval shall be required
for subsequent uses of the same data in the same form.
(i) If and to the extent that XOMA
owns or has the right to use, sell, license, transfer or otherwise
exploit copies of the Article 3A Know-How and the Systems, the
Source Code, the Software, the Know-How used by XOMA to construct
[*] the Article 3A Patent Rights and/or any other Patent Right,
copyright or other item of intellectual property that covers or
claims the Transferred Materials and/or their creation,
construction or use, except as expressly set forth in
Section 3A.2(g) and elsewhere herein, nothing in this Second
Amendment is intended to limit or prevent XOMA from exercising such
ownership or rights.
(j) [*]
3A.3 Takeda Inventions/Unblocking
Covenant Not to Sue . Without limiting or expanding the results
under applicable patent law, the parties acknowledge that Takeda
shall be free to seek and obtain patent protection for any
inventions of Takeda [*] provided , however ,
that:
(a) Takeda covenants not to sue any
XOMA Company under the Takeda Discovery Patent Rights if any XOMA
Company uses, for itself or on behalf of a XOMA Collaboration
Partner, the Licensed Technology and Discovery Patent Rights, as
such technology and patent rights exist as of the Amendment
Effective Date [*] (regardless of location). Takeda covenants not
to sue any XOMA Collaboration Partner under the Takeda Discovery
Patent Rights if such XOMA Collaboration Partner, or XOMA on behalf
of such XOMA Collaboration Partner, uses the Licensed Technology
and Discovery Patent Rights, as such technology and patent rights
exist as of the Amendment Effective Date [*] within the scope of
XOMA and such XOMA Collaboration Partner’s collaboration
(regardless of location).
(b) Takeda covenants not to sue XOMA
under the Takeda Discovery Patent Rights if XOMA uses the Licensed
Technology and Discovery Patent Rights, as such technology and
patent rights may be improved after the Amendment Effective Date by
XOMA [*]
(c) Takeda covenants not to sue any
XOMA Collaboration Partner under the Takeda Discovery Patent Rights
if such XOMA Collaboration Partner, or XOMA on behalf of such XOMA
Collaboration Partner, uses the Licensed Technology and Discovery
Patent Rights, as such technology and patent rights may be improved
after the Amendment Effective Date by XOMA [*] within the scope of
XOMA and such XOMA Collaboration Partner’s
collaboration.
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None of the foregoing covenants shall extend to
any Takeda Discovery Patent Rights to the extent they claim
Discovery Products.
3A.4 [*] (a) Takeda may, in its
discretion at any time or times on or before [*] order up to [*] of
[*]. Prior to placing such an order, Takeda shall initiate
technical discussions with XOMA pursuant to which the Parties will
set forth in writing Takeda’s specifications [*] for [*] to
be ordered. Such specifications shall identify whether such [*] are
to be [*] and include other elements such as [*]. Upon agreement
between the Parties on the technical capability of XOMA or its
Affiliates to deliver [*] embodying the specifications [*] Takeda
will place a firm purchase order and provide [*] for the
construction of such [*]
(b) Once (i) the Parties have
agreed on the technical capability of XOMA or its Affiliates to
deliver [*] embodying the specifications (including design
elements) referred to in Section 3A.4(a), (ii) XOMA has
received [*] and provided written confirmation that they are [*]
(iii) Takeda or, as applicable, a Designated Takeda Affiliate
has placed a firm purchase order therefor, and (iv) Takeda has
paid the requisite fee pursuant to Section 7A.1(b)(i) or (ii),
as applicable, XOMA shall design, construct and have available for
delivery to Takeda such [*] meeting the Applicable Specifications
not later than [*] from the last to occur of clauses
(i) through (iv).
(c) Once a particular set of [*] has
been validated by XOMA but prior to delivery thereof to Takeda or,
as applicable, a Designated Takeda Affiliate, XOMA shall provide to
Takeda or such Designated Takeda Affiliate such data as is
reasonably necessary to determine whether such [*] are in
accordance with the specifications referred to in
Section 3A.4(a). Takeda or, as applicable, such Designated
Takeda Affiliate shall have [*] following receipt of such data by
Takeda or such Designated Takeda Affiliate to determine whether it
agrees that such [*] are in accordance with such specifications and
to notify XOMA of such determination, or it shall be deemed to have
agreed that the [*] meet the applicable specifications.
(i) If, within such [*] day period,
Takeda or, as applicable, such Designated Takeda Affiliate notifies
XOMA that it does not agree that such [*] are in accordance with
such specifications, XOMA shall promptly provide such data to a
mutually acceptable independent Third Party, which shall review
such data, under confidentiality, for the sole purpose of making a
final and binding determination as to whether such [*] are in
accordance with such specifications. If, following its review, such
Third Party determines that such [*] are not in accordance with
such specifications, then the third sentence of
Section 7A.1(b) shall apply and XOMA shall promptly destroy
such [*]. The [*] period referred to in Section 3A.4(b) shall
be tolled for the period between XOMA’s provision of data to
the Third Party reviewer and the reviewer’s determination.
The Party against which the Third Party reviewer rules shall bear
all costs of the Third Party review.
(ii) If either (x) Takeda or,
as applicable, the Designated Takeda Affiliate agrees based on its
review of the data that such [*] are in accordance with such
specifications or (y) the Third Party reviewer determines that
such [*] are in accordance with such specifications, then XOMA
shall, under the same conditions as the transfer and delivery of
[*] and the Discovery Know-How relating thereto, assign all right,
title and interest in, and deliver [*] and the Discovery Know-How
relating thereto, to Takeda or at Takeda’s election, to a
Designated Takeda Affiliate.
3A.5 Designation of Additional
Affiliates, Transfers to Additional Sites and Limitations on Use
and Modification .
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(a) Takeda shall be permitted to
designate to XOMA in writing up to, at any one time, [*] additional
Takeda Affiliates to which the Transferred Materials may be
transferred and delivered or through which Takeda wishes to
exercise rights or perform obligations under this Agreement;
provided, however, that Takeda shall obtain, prior to any such
transfer and delivery, a written acknowledgement, separately
enforceable by XOMA as a third-party beneficiary, by such
Designated Takeda Affiliate that it shall abide by any and all
requirements of the Agreement applicable to the transfer and use of
the Transferred Materials. Upon receipt by XOMA of such written
designation and acknowledgement, the Agreement shall be deemed
amended to the extent necessary to include such Designated Takeda
Affiliate as being entitled to the rights and subject to the
obligations applicable to Takeda hereunder. Takeda shall be free to
change such designation to any Takeda Affiliate. Takeda hereby
guarantees, without any requirement of written demand by XOMA, the
performance of and compliance with the Agreement by Takeda SF and
any other Designated Takeda Affiliate.
(b) Subject to Section 3A.5(a),
(i) Takeda may move the Transferred Materials to any other
Takeda site (including its Affiliates’) of its selection that
is and will remain under its control and has reasonable safeguards
designed to protect the Transferred Materials from theft, vandalism
or unauthorized use, and (ii) Takeda may transfer to any CRO
that, to Takeda’s knowledge, has reasonable safeguards
designed to protect such materials from theft, vandalism,
unauthorized use, alteration or modification, the following
materials solely for the corresponding purposes: (x) [*]or
(y) [*] and TES Technology specific to such research program
and data outputs for the performance of such research
program.
(c) The parties agree that the
transfers provided for by this Article 3A arise out of and are part
of the existing collaboration and that the use of the Transferred
Materials and the practice of the Article 3A Patent Rights and any
other Patent Rights to which rights are assigned or granted
pursuant to this Article 3A may, subject to the applicable
provisions of the Agreement, be used by Takeda or, as applicable, a
Designated Takeda Affiliate for any other purpose including the [*]
development and subsequent commercial sale of any composition of
matter in the Field. Nothing in this subsection shall restrict
Takeda from being able to [*]. Notwithstanding the foregoing, the
following restrictions shall apply to the Transferred
Materials:
(i) Takeda shall not, and shall not
permit its Affiliates and CROs to, alter or modify [*]. The
Transferred Materials may not be further transferred or disposed of
by Takeda to a Third Party (other than to a CRO as provided in
Section 3A.5(b)); provided, however, that [*]
(ii) Neither Takeda nor, as
applicable, any Designated Takeda Affiliate shall use the
Transferred Materials or practice the Article 3A Patent Rights and
any other Patent Rights to which rights are assigned or granted by
a XOMA Company pursuant to this Article 3A on behalf of any Third
Party [*] or otherwise engage in activities not directly associated
with Takeda’s or Takeda Affiliate’s own internal [*]
research and development programs; provided , however
, that, so long as the other limitations of this Article 3A are
satisfied, Takeda or, as applicable, a Designated Takeda Affiliate
may use the Transferred Materials or practice the Article 3A Patent
Rights and any other Patent Rights assigned or granted by a XOMA
Company pursuant to this Article 3A with respect to any Discovery
Product, Antibody or Antibody Product as to which Takeda or a
Designated Takeda Affiliate has either in-licensed or acquired
rights from a Third Party where such in-license or grant of rights
is for the exclusive development of such Discovery Product,
Antibody or Antibody Product or variants thereof by Takeda, either
alone or in collaboration with such Third Party.
3A.6 [*]
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(c) The Agreement is hereby supplemented by adding
the following Article 6A following existing Article 6:
ARTICLE 6A
ADDITIONAL
LICENSES
6A.1 [*]
6A.2 [*]
6A.3 Informatics Systems
License . Subject to the terms of this Second Amendment and
Schedule 6A.3, XOMA hereby grants to Takeda, in the Field in the
Territory during the Systems License Term, a non-exclusive right
and license, without the right to sublicense, under the Systems to
make, have made, use, sell, offer to sell, import and export any
products and (solely to the extent required for exercising the
foregoing rights) to reproduce (but not for commercial distribution
purposes), modify, publicly perform, and publicly display the
Systems and all copyrights therein. Notwithstanding the foregoing,
in no event shall Takeda publicly disseminate without XOMA’s
prior written consent non-public Systems source code or created
work based on Systems source code, such as screen shots, flow
charts, object code and/or algorithms, with the exception of data
produced by execution of the source code.
6A.4 TES Technology License .
Subject to the terms of this Second Amendment, XOMA hereby grants
to Takeda, in the Field in the Territory during the TES License
Term, a perpetual, non-exclusive right and license, without the
right to sublicense, under the TES Technology to make, have made,
use, sell, offer to sell, import and export any Antibody
Products.
6A.5 HE™ Technology
License . Subject to the terms of this Second Amendment, XOMA
hereby grants to Takeda, in the Field in the Territory during the
HE™ License Term, a perpetual, non-exclusive right and
license, without the right to sublicense, under the HE™
Technology to make, have made, use, sell, offer to sell, import and
export any Antibody Products, and (solely to the extent required
for exercising the foregoing rights) as to software included
therein, to reproduce for Takeda’s purposes, modify, publicly
perform, and publicly display such software and all copyrights
therein. Notwithstanding the foregoing, in no event shall Takeda
publicly disseminate without XOMA’s prior written consent
non-public software source code or created work based on software
source code, such as screen shots, flow charts, object code and/or
algorithms, with the exception of data produced by execution of the
source code.
6A.6 BCE Technology License for
HE™ . Subject to the terms of this Second Amendment, XOMA
hereby grants to Takeda a non-exclusive right and license during
the BCE 6A.6 License Term, without the right to sublicense, to use
the BCE Technology solely to conduct activities related to
selection of a lead product candidate from among a group of variant
sequences derived using the HE™ Technology as provided in,
and as limited by, the scope of the license grants in
Section 6A.5 but not to make or have made any quantities of
any compound or product, including an Antibody, in a prokaryote
except as reasonably necessary to conduct non-clinical research and
development activities using [*] including in vitro and
small animal in vivo research and development, and not for
clinical development or for the manufacture for sale of any
compound or product, including an Antibody.
The grants provided for in this
Section 6A include, to the extent required, a right and
license to [*] use, sell, offer to sell, import or export any
(1) Discovery Product and (2) any Antibody or Antibody
Product derived from or arising out of, directly or indirectly, the
use of the other Transferred Materials or the practice of the other
Article 3A Patent Rights.
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6A.7 Third Party Licenses
.
(a) For the avoidance of doubt, the
license grants in this Second Amendment are intended to include all
Third Party licenses and covenants not to sue relating to the
Licensed Technology or [*] directly or indirectly owned or
controlled by XOMA, to the extent such Third Party licenses and
covenants not to sue are permitted by their terms to be so
included. [*] In the event that XOMA is or becomes unable to grant
Takeda, or any Designated Takeda Affiliate, any of the rights
described under this Article 6A, and to the extent that a XOMA
Affiliate [*] has the necessary right, power and authority to grant
Takeda, or any Designated Takeda Affiliate, such rights, the
applicable XOMA Affiliate hereby grants to Takeda, or a Designated
Takeda Affiliate, such rights to the extent and under the terms
contained herein.
(b) [*]
(c) The first sentence of
Section 6.3 of the Agreement is hereby amended to add the
words “or Discovery Product” after the words
“Collaboration Product.”
(d) [*]
(d) The Agreement is hereby supplemented by adding
the following Article 7A following existing Article 7:
ARTICLE 7A
ADDITIONAL FINANCIAL
TERMS
7A.1 Second Amendment Financial
Terms . In further consideration for XOMA’s full and
timely performance under the Agreement, including the transfers and
deliveries required, and licenses granted under this Second
Amendment:
(a) Second Amendment Fee .
Subject to satisfaction by XOMA or waiver by Takeda of the
conditions to payment set forth in Section 4 of this Second
Amendment, Takeda shall have up to [*] after the later of
(i) [*] and (ii) receipt of the materials by Takeda SF
pursuant to Section 3A.1 to [*] pay to XOMA a one-time fee
equal to $29,000,000.
(b) [*]
(c) Second Amendment
Milestones .
(x) Subject to
Section 7A.1(c)(y) below, for each Royalty-Bearing
Discovery
