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Exhibit 10.46
[*] indicates that a confidential portion of the
text of this agreement has been omitted.
COLLABORATION AGREEMENT
This Collaboration Agreement (this " Agreement ") is
dated as of November 1, 2006 (the " Effective Date ")
and is made by and between Takeda Pharmaceutical Company Limited, a
Japanese corporation having offices at 1-1, Doshomachi 4-chome,
Chuo-ku, Osaka 540-8645, Japan (hereinafter " Takeda "); and
XOMA (US) LLC, a Delaware limited liability company having offices
at 2910 Seventh Street, Berkeley, California 94710, USA
(hereinafter " XOMA "). Takeda and XOMA are sometimes
referred to herein individually as a " Party " and
collectively as the " Parties ."
R E C I T A L S
WHEREAS, Takeda and XOMA are each in the business of, among
other things, discovering and developing products for the
prevention or treatment of human diseases and conditions;
WHEREAS, Takeda (a) has technology for and expertise in the
identification and validation of targets for use in the discovery
of such products, and has identified and validated, and continues
to identify and validate, target antigens for use in the discovery
of antibodies potentially useful for such purposes, and
(b) has personnel with expertise in the development of such
products;
WHEREAS, XOMA has technology for and expertise in the discovery,
optimization, development and manufacturing of antibodies
potentially useful for such purposes;
WHEREAS, Takeda and XOMA are interested in collaborating
(a) in the discovery of antibodies to target antigens
identified and validated by Takeda and (b) in the development
of such antibodies for use in the prevention or treatment of human
diseases and conditions;
WHEREAS, it is anticipated that XOMA will have primary
responsibility for research and preclinical development activities
relating to the target antigens that are the subject of the
Parties’ collaboration, including antibody discovery,
identification of antibodies suitable for supporting
Investigational New Drug application filing(s) and the
manufacturing of clinical trial material for such antibodies during
their clinical development; and
WHEREAS, it is anticipated that Takeda will have primary
responsibility for all activities relating to development and
commercialization of Collaboration Products including without
limitation the filing of Investigational New Drug applications,
clinical development and the sales and marketing of Collaboration
Products.
NOW, THEREFORE, in consideration of the premises and of the
covenants herein contained, the Parties hereto mutually agree as
follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in this
Article 1 shall have the respective meanings specified below:
1.1 " Additional Upfront Fee " has the meaning specified
in Section 7.1 hereof.
1.2 " Adverse Drug Reaction " means any untoward medical
occurrence in a patient or subject who is administered a
Collaboration Product, the occurrence of which should be reported
to one or more Regulatory Authorities in accordance with applicable
Laws where the Collaboration Product is being administered to
patients or subjects.
1.3 " Affiliate " means any corporation, company,
partnership, joint venture and/or firm that controls, is controlled
by or is under common control with a Party to this Agreement. 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). Notwithstanding the
foregoing, TAP Pharmaceutical Products, Inc. and its subsidiaries,
TAP Pharmaceuticals Inc. and TAP Finance Inc., shall be deemed
Affiliates of Takeda for purposes hereof so long as Takeda directly
or indirectly owns fifty percent (50%) or more of the stock or
shares entitled to vote for the election of directors thereof.
1.4 " Annual Maintenance Fee " has the meaning specified
in Section 7.2 hereof.
1.5 " Antibody " means any immunoglobulin molecule
whether in monospecific or any other form and shall include,
without limitation, immunoglobulin fragments, such as Fv, Fab,
F(ab’) and single-chain antibodies.
1.6 " Antibody Product " means any composition of matter
or article of manufacture consisting essentially of an Antibody
(a) alone or (b) integrally associated with a composition
of matter or article of manufacture (including without limitation
conjugates bound to a toxin, label or other moiety) providing
therapeutic, half-life, safety or other advantages to the
Antibody.
1.7 " Antibody Related Claim " has the meaning specified
in Section 6.1.1 hereof.
1.8 " Applicable Interest Rate " has the meaning
specified in Section 7.12 hereof.
1.9 " Bankruptcy Code " has the meaning specified in
Section 14.3 hereof.
1.10 " Batch " means a specific volume, produced in a [*]
or larger size bioreactor, of cell culture fluid processed through
to bulk drug substance that is intended to have a uniform character
and quality, within specified limits, and that is produced
according to a single manufacturing order during the same cycle of
manufacture.
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1.11 " Batch Price " means the price
associated with the production of each Batch (excluding FTE Costs
for internal analytical testing as provided in Section 1.59
and Third Party costs as provided in Section 7.6.2) and,
during the period from the Effective Date until December 31,
2006, shall be as follows: [*] for each [*] scale Batch; [*] for
each [*] scale Batch; and [*] for each [*] scale Batch. Batch
Prices shall be adjusted annually beginning January 1, 2007 by
XOMA, [*].
1.12 " BLA " means a Biologics Licensing Application (as
defined in the FDC Act) and any other equivalent marketing
authorization application or other license, registration or
application seeking approval from a Regulatory Authority to market
a Collaboration Product in the Field in the Territory.
1.13 " Cancer " means a condition or disease primarily
characterized by uncontrolled growth or spread of abnormal and
anaplastic cells, metastases, neoplasm, malignant tumors and/or
invasion by abnormal and anaplastic cells into tissues regardless
of cause. For the avoidance of doubt, Cancer shall not include
inflammation, infection or conditions characterized solely by
hypertrophy or hyperplasticity of normal cells.
1.14 " cGMP Guidelines " means the FDA’s current
good manufacturing practice guidelines as promulgated under the FDC
Act and 21 C.F.R. (parts 210 and 211), and as further defined by
FDA guidance documents, as amended from time to time.
1.15 " Change of Control " means a transaction or a
series of related transactions (collectively, the "
Transaction ") wherein the shareholders of a company or its
parent company immediately before the Transaction do not retain
immediately after the Transaction, in substantially the same
proportions as their ownership of voting shares of such company or
its parent company immediately before the Transaction, direct or
indirect beneficial ownership of more than two-thirds
(66.67%) of the total combined voting power of the outstanding
voting shares of the company or the entity or entities to which the
assets of the company were transferred (the " Transferee
Corporation "), as the case may be. For purposes of the
preceding sentence, indirect beneficial ownership shall include,
without limitation, an interest resulting from ownership of the
voting shares of one or more entities which, as a result of the
Transaction, own the company or the Transferee Corporation(s), as
the case may be, either directly or through one or more
subsidiaries.
1.16 " Chiron Agreement " has the meaning specified in
Section 1.17 hereof.
1.17 " Chiron Exclusivity Period " shall mean the
exclusivity period provided for in Section 3.2 of the
May 26, 2005 Research, Development and Commercialization
Agreement between Chiron Corporation and XOMA (the " Chiron
Agreement "). As of the Effective Date, although the Chiron
Exclusivity Period is scheduled to expire on February 27,
2007, it may be extended to not later than February 27, 2009.
In the event that XOMA learns that such expiration date changes or
is reasonably expected to change, XOMA shall inform Takeda within
ten (10) business days of such change or expected change in
writing as well as the known or anticipated new expiration
date.
1.18 " Collaboration " has the meaning specified in
Section 2.1.1 hereof.
1.19 " Collaboration Committee " means the Joint Steering
Committee, JRDC or Joint Patent Committee. "Collaboration
Committees" means any combination of the foregoing.
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1.20 " Collaboration Product " means a
Program Antibody that has been selected by Takeda at the Joint
Steering Committee as a lead or backup development candidate for
further development under the Collaboration.
1.21 " Collaboration Target " means any Proposed Target
that has been selected for Research and Development in accordance
with Section 2.2 hereof.
1.22 " Combination Product " has the meaning specified in
Section 1.62 hereof.
1.23 " Commercially Reasonable and Diligent Efforts "
means the carrying out of obligations or tasks by a Party in a
sustained manner using good faith commercially reasonable and
diligent efforts, which efforts shall be consistent with the
exercise of prudent scientific and business judgment in accordance
with either (a) the efforts such Party devotes to products or
research and development projects of similar scientific and
commercial potential, or (b) if such Party does not have and
has not had any such products or projects, the efforts a peer
company in the biopharmaceutical industry would devote, in
accordance with industry standards and practices, to products or
research and development projects of similar scientific and
commercial potential, and subject in any event to any Pre-existing
Obligations of such Party properly disclosed to the other Party in
accordance herewith.
1.24 " Confidential Information " means any information
and data received by a Party (the " Receiving Party ") from
the other Party or its Affiliates (the " Disclosing Party ")
in connection with this Agreement or the Confidential Disclosure
Agreement made as of February 8, 2006 between the Parties
(including, without limitation, any terms of this Agreement, all
information disclosed by the Parties under Article 2 hereof and any
research, testing, clinical, regulatory, marketing or other
scientific or business information, plans, or data pertaining to
any Collaboration Product of the Disclosing Party). Notwithstanding
the foregoing, Confidential Information shall not include any part
of such information or data:
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(a) which is or becomes public knowledge (through no fault of
the Receiving Party); or
(b) which is made available to the Receiving Party by a Third
Party not under an obligation of confidentiality with the
Disclosing Party (and such lawful right can be demonstrated by the
Receiving Party’s written records); or
(c) which is already rightfully in the Receiving Party’s
possession at the time of receipt from the Disclosing Party (and
such prior possession can be demonstrated by the Receiving
Party’s written records); or
(d) which is independently developed by an employee of the
Receiving Party and/or its Affiliates without the aid, application
or use of confidential information disclosed by the Disclosing
Party (and such independent development can be demonstrated by the
Receiving Party’s written records).
[*]
1.25 " Contract Quarters " has the meaning specified in
Section 1.26 hereof.
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1.26 " Contract Year " means, with respect
to a particular Collaboration Target, (a) with respect to the
first Contract Year, the period beginning on the date such
Collaboration Target is accepted into the Collaboration (or, in the
case of the first Collaboration Target, the Effective Date) and
ending on December 31 of the calendar year in which such
acceptance takes place (which in the case of the first
Collaboration Target is December 31, 2006) (such period, the "
First Contract Year "), and (b) with respect to each
subsequent Contract Year, the twelve (12) month period
beginning on the day following the end of the First Contract Year
and each succeeding twelve (12) month period thereafter. Each
Contract Year (other than the First and last Contract Years, as
applicable) shall be divided into four (4) " Contract
Quarters " comprised of successive three (3) month
periods. In the First Contract Year, the first Contract Quarter
shall begin on the first day of the First Contract Year and shall
end on the last day of the calendar quarter in which the relevant
Collaboration Target is accepted into the Collaboration (which in
the case of the first Collaboration Target is December 31,
2006).
1.27 " Control " or " Controlled " means, 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
or license, 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 and/or a sublicense 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.
1.28 " Cover ," " Covered " or " Covering "
means, with respect to a Patent Right, that, but for rights granted
to a person or entity under such Patent Right, the practice by such
person or entity of an invention claimed in such Patent Right would
infringe a Valid Claim included in such Patent Right, or in the
case of a Patent Right that is a patent application, would infringe
a Valid Claim in such patent application if it were to issue as a
patent.
1.29 " Disclosing Party " has the meaning specified in
Section 1.24 hereof.
1.30 " Effective Date " means the date specified in the
initial paragraph of this Agreement.
1.31 " EMEA " means the European Medicines Agency, or any
successor thereto.
1.32 " Escrow Agent " means an independent Third Party
consultant hired by XOMA with whom XOMA has deposited a list of
Excluded Targets, which XOMA may update from time to time, and who
shall notify Takeda which, if any, Proposed Targets are Excluded
Targets.
1.33 [*].
1.34 " Event of Default " means an event described in
Section 13.4 hereof.
1.35 " Excluded Target " means a Target that XOMA has
elected, in its sole discretion, to exclude from consideration for
inclusion in the Collaboration and is identified on the list of
Excluded Targets deposited with the Escrow Agent prior to such
Target being designated as a Proposed Target by Takeda.
1.36 " FDA " means the United States Food and Drug
Administration, or any successor thereto.
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1.37 " FDC Act " means the United States
Food, Drug and Cosmetic Act (or any successor thereto), as amended,
and the rules and regulations promulgated thereunder.
1.38 " Field " means any and all uses except, until the
expiration or termination of the Chiron Exclusivity Period, the
diagnosis, prevention, control or treatment of Cancer; [*]. For
avoidance of doubt, upon the expiration or termination of the
Chiron Exclusivity Period, the Field shall become automatically any
and all uses including but not limited to the diagnosis,
prevention, control or treatment of Cancer.
1.39 " First Commercial Sale " means the first sale for
use or consumption by the general public of a Collaboration Product
in a country after Regulatory Approval has been obtained in such
country. For the avoidance of doubt, First Commercial Sale shall
not include the sale of any Collaboration Product for use in
clinical trials or for compassionate use prior to Regulatory
Approval.
1.40 " First Contract Year " has the meaning specified in
Section 1.26 hereof.
1.41 " First Upfront Fee " has the meaning specified in
Section 7.1 hereof.
1.42 " FTE " means a full-time person dedicated to the
R&D Plan activities or Manufacturing Plan activities, as
applicable, or in the case of less than a full-time, dedicated
person, a full-time, equivalent person year, based, in either case,
upon a total of [*] hours per year of work in connection with
R&D Plan activities or Manufacturing Plan activities, as
applicable.
1.43 " FTE Costs " means the amounts determined by
multiplying (a) the number of FTEs contributed by a Party
toward R&D Plan activities or Manufacturing Plan activities
during the relevant time period, subject to any limitations set
forth in the applicable R&D Plan or Manufacturing Plan and
associated budget(s) or otherwise established by the Joint Steering
Committee, by (b) the applicable FTE Rates.
1.44 " FTE Rate " means, for each functional area, the
rate set forth below corresponding to such functional area, to be
adjusted annually (beginning in January of 2007) for inflation
using the latest available U.S. Producer Price Index for Total
Manufacturing Industries, unadjusted (PCUOMFG#) as published by the
Bureau of Labor Statistics; [*]. In addition, the Joint Steering
Committee shall discuss and approve, as needed, further adjustments
to FTE Rates [*] on a prospective basis beginning in [*].
Establishment of annual FTE Rates for functional areas not set
forth in the table below shall be the responsibility of the JRDC
based on XOMA’s then-current FTE rates. Such rates will be
used to determine the R&D Plan and related budget for the
applicable annual period.
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Functional Area
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Annual FTE Rate
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Preclinical
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[*]
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Clinical
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[*]
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Regulatory
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[*]
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Pilot Plant (Process Development)
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[*]
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Quality
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[*]
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Technical Development (Cell Line Work and Assay
Development)
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[*]
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Project Management
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[*]
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1.45 " GAAP " means United States
generally accepted accounting principles, as they exist from time
to time, consistently applied.
1.46 " Human Engineering™ Technology " means the
Human Engineering™ technology Controlled by XOMA, as more
fully described in Schedule 1.46 .
1.47 " IND " means an Investigational New Drug
application filed with the U.S. Food and Drug Administration or a
similar application for the clinical testing of a Collaboration
Product in human subjects filed with a foreign Regulatory
Authority.
1.48 " Indemnitee " has the meaning specified in
Section 12.4 hereof.
1.49 " Indemnitor " has the meaning specified in
Section 12.4 hereof.
1.50 " Joint Patent Committee " has the meaning specified
in Section 3.1.3 hereof.
1.51 " Joint Project Team " has the meaning specified in
Section 3.1.2 hereof.
1.52 " Joint Steering Committee " has the meaning
specified in Section 3.1.1 hereof.
1.53 " JRDC " has the meaning specified in
Section 3.1.2 hereof.
1.54 " Know-How " means any and all know-how, trade
secrets, data, processes, techniques, procedures, compositions,
materials, devices, methods, formulas, protocols, and research,
preclinical and clinical data and information, including any and
all chemical, biochemical, toxicological, and scientific research
information, whether in written, electronic, graphic or video form
or any other form or format. Know-How shall not include Patent
Rights.
1.55 " Laws " means all laws, statutes, rules,
regulations, ordinances and other pronouncements having the effect
of law of any federal, national, multinational, state, provincial,
county, city or other political subdivision, domestic or
foreign.
1.56 " Lead Antibody " has the meaning specified in
Section 7.3.4(a) hereof.
1.57 " License Agreements " means the license agreements
listed in Schedule 1.57 , which list shall be updated from
time to time as necessary to reflect additional license agreements
entered into by XOMA after the Effective Date, the inclusion of
which in the Collaboration has been agreed to by the Joint Steering
Committee as provided in Section 2.7.
1.58 " Manufacturing " or " Manufacture " means
all activities set forth in the applicable Manufacturing Plan
associated with the production, processing, formulating, filling,
finishing and packaging of Collaboration Products in the Field,
including pilot plant process development; pilot plant stability
testing; manufacturing process development; manufacturing process
and assay validation;
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manufacturing scale-up; preclinical, clinical and
commercial manufacture; and analytical development, quality
assurance and quality control activities.
1.59 " Manufacturing Costs " means, with respect to the
Manufacture of a Collaboration Product as set forth in the
applicable Manufacturing Plan, the [*] internal costs of XOMA,
which costs shall be determined based on (i) FTE Costs or
(ii) with respect to Batches of the scale sizes referred to in
Section 1.11, the Batch Price, and the [*] costs billed to
XOMA by Third Parties, in each case consistent with and directly
related to the budget set forth in the applicable Manufacturing
Plan incurred in cell line development; pilot plant process and
assay development; manufacturing process development; manufacturing
process improvement; manufacturing scale-up; the development of
manufacturing standard operating procedures, batch records, and
quality assurance and quality control methods and procedures; and
the time of manufacturing personnel for preparing, submitting,
reviewing or developing data or information for the purpose of a
drug master file or for submission to a Regulatory Authority.
1.60 " Manufacturing Plan " has the meaning specified in
Section 5.1.1 hereof.
1.61 " Master Cell Bank " means an aliquot of a single
pool of cells which generally has been prepared from the selected
cell clone under defined conditions, dispensed into multiple
containers and stored under defined conditions. The single pool of
cells will be generated from a cell line having agreed upon
characteristics established prior to the initiation of preparation
of such Master Cell Bank pursuant to the R&D Program, or as
subsequently agreed to by the Joint Steering Committee, based on
relevant cGMP and GLP standards [*].
1.62 " Net Sales " means, with respect to a Collaboration
Product, the gross amount invoiced for sales of such Collaboration
Product to customers which are not Affiliates (or which are
Affiliates but are end users of such Collaboration Product), less
the following unreimbursed or non-refunded deductions with respect
thereto, determined in accordance with GAAP and calculated in
United States dollars and to the extent such amounts have not
already been deducted from the amount invoiced: (a) amounts
actually allowed as volume or quantity discounts, rebates, price
reductions, returns (including recalls) and charge-backs (including
without limitation, with respect to any Net Sales in Japan, any
sales-based contribution for "Drug Induced Suffering" and any
sales-based contribution for "Contribution for Measure for Drug
Safety," in each case as required by applicable Laws or Regulatory
Authority in the amount determined by and payable to the
Pharmaceuticals and Medical Devices Agency (so-called "KIKO")),
(b) sales, excise and turnover taxes and similar duties,
levies and charges collected, charged or otherwise imposed directly
upon and actually paid by such party and its Affiliates, and
(c) all other direct expenses or discounts, including but not
limited to cash discounts, custom duties and transportation and
insurance charges.
In the event the Collaboration Product is sold as part of a
Combination Product (as defined below), the Net Sales from the
Combination Product, for the purposes of determining royalty
payments, will be determined by [*].
In the event that the average sale price of the Collaboration
Product can be determined but the average sale price of the other
active compounds or active ingredients in the Combination Product
cannot be determined, Net Sales for purposes of determining royalty
payments will be calculated by [*]. If the average sale price of
the other active compounds or active ingredients can be determined
but the average price of the Collaboration Product cannot be
determined, Net Sales for purposes of determining royalty payments
will be calculated by [*].
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In the event that the average sales price of both
the Collaboration Product and the other active compounds or active
ingredients in the Combination Product cannot be determined, the
Net Sales of the Collaboration Product shall be negotiated in good
faith by the Parties.
As used above, the term " Combination Product " means any
Collaboration Product sold in conjunction with any other active
component(s) (whether packaged together or in the same therapeutic
formulation).
Free samples of Collaboration Product and the disposition of
Collaboration Product for, or the use of Collaboration Product in,
preclinical or clinical (Phase 1–3) trials or other
market-focused (Phase 4) trials in which Collaboration Product
is provided to patients without any payment shall not result in any
Net Sales.
1.63 " Patent Prosecution " has the meaning specified in
Section 9.2.1 hereof.
1.64 " Patent Rights " means all patents and patent
applications existing as of the Effective Date and all patent
applications thereafter filed and patents thereafter issued,
including, without limitation, any continuations,
continuations-in-part, divisionals, provisionals or any substitute
applications, any patent issued with respect to any such patent
applications, any reissue, reexamination, renewal or extension
(including any supplemental protection certificate) of any such
patent, and any confirmation patent or registration patent or
patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing.
1.65 " Phage Display Technology " means an in vitro
selection technique that enables polypeptides (e.g. human antibody
fragment) with desired properties to be extracted from a repertoire
of many different polypeptides or variants, utilizing the ability
to display polypeptides on the surface of bacteriophage.
1.66 " Phase 1 Trial " means a human clinical trial
in any country that is intended to initially evaluate the safety
and/or pharmacological effect of a Collaboration Product in
subjects or that would otherwise satisfy the requirements of 21
C.F.R. 312.21(a), or its foreign equivalent. For purposes of this
Agreement, " commencement of a Phase 1 Trial " for a
Collaboration Product means the first introduction of such
Collaboration Product into a human patient in a Phase 1
Trial.
1.67 " Phase 2 Trial " means a human clinical trial
in any country that is intended to initially evaluate the
effectiveness of a Collaboration Product for a particular
indication or indications in patients with the disease or
indication under study or that would otherwise satisfy the
requirements of 21 C.F.R. 312.21(b), or its foreign equivalent. For
purposes of this Agreement, " commencement of a Phase 2
Trial " for a Collaboration Product means the first
introduction of such Collaboration Product into a human patient in
a Phase 2 Trial.
1.68 " Phase 3 Trial " means a pivotal human
clinical trial in any country, the results of which could be used
to establish safety and efficacy of a Collaboration Product as a
basis for a BLA or that would otherwise satisfy the requirements of
21 C.F.R. 312.21(c) or its foreign equivalent. For purposes of this
Agreement, " commencement of a Phase 3 Trial " for a
Collaboration Product means the first introduction of such
Collaboration Product into a human patient in a Phase 3 Trial.
In the event of a Phase 2/3 trial, initiation of Phase 3
shall be deemed to have occurred upon a decision by Takeda to
continue enrollment for the pivotal portion of such trial.
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1.69 " Plan " means the R&D Plan or
Manufacturing Plan, as the case may be.
1.70 " Pre-existing Obligations " means the obligations
of Takeda or XOMA, as the case may be, existing (a) with
respect to Takeda Background Technology or XOMA Background
Technology, under agreements in effect prior to the Effective Date
and listed on Schedule 1.70 , and (b) with respect to
any Collaboration Target other than the initial Collaboration
Target referred to in Section 2.2.1, under agreements in
effect at the time such Collaboration Target is designated as such
pursuant to Section 2.2 and disclosed in writing by the Party
subject to such obligation(s) to the other Party.
1.71 " Program Antibody " means an Antibody Product that
(a) is identified or discovered by XOMA in the course of the
Collaboration, or (b) the Parties agree to acquire from a
Third Party, and, in the case of clauses (a) and (b),
selectively binds to and acts through a Collaboration Target;
provided , however , that in no event shall an
Antibody Product that is subject to one or more Pre-existing
Obligations become a Program Antibody unless such designation is
affirmatively agreed to by the Joint Steering Committee after
disclosure of the nature of such Pre-existing Obligation(s) by the
applicable Party, such agreement not to be unreasonably withheld or
delayed.
1.72 " Program Director " has the meaning specified in
Section 3.2 hereof.
1.73 " Program Materials " means (a) any Program
Antibodies and (b) any materials other than Program Antibodies
Controlled by a Party or jointly by the Parties that are first
identified, discovered or created in the conduct of the
Collaboration and during the applicable Program Term including, but
not limited to, (i) a cell line producing a Program Antibody
and (ii) plasmid DNA incorporating the cDNA with respect to a
Program Antibody.
1.74 " Program Patent Rights " means any Patent Rights
Controlled by a Party or jointly by the Parties that Cover any
Program Technology or Program Materials.
1.75 " Program Technology " means any and all Know-How
and inventions Controlled by a Party or jointly by the Parties that
are first invented, identified, discovered, made, conceived,
reduced to practice or otherwise licensed or acquired in the
conduct of the Collaboration and during the applicable Program
Term; provided that Know-How or inventions that constitute
an improvement to the Human Engineering™ Technology
(including any Know-How or inventions otherwise meeting this
definition and constituting an improvement thereto) shall not be
included in Program Technology. For clarity, Program Technology
excludes Program Materials.
1.76 " Program Term " has the meaning specified in
Section 2.1.2 hereof.
1.77 " Proposed Targets " has the meaning specified in
Section 2.2.2 hereof.
1.78 " Qualified Generic " means, with respect to a
particular Collaboration Product in a given country, a generic
product (i.e., referred to as a follow-on biologic in the U.S. or a
biosimilar medicinal product in the E.U.) that has received
Regulatory Approval in such country in the Territory (i) on
the basis of the quality, safety and efficacy of such Collaboration
Product and (ii) as a substitute for such Collaboration
Product in such country has achieved sales revenues exceeding [*]
of the sales revenues of Collaboration Product sold by Takeda or
its sublicensees in such country based on monthly IMS data if
available, or equivalent data for that country if IMS data is not
available.
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1.79 " R&D Costs " means costs and
expenses that are incurred after the Effective Date by either Party
in performing Research and Development activities consistent with
and directly related to an applicable R&D Plan and associated
budget, including:
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(a) the [*] costs of internal scientific, medical, technical,
and/or managerial personnel engaged in R&D Plan activities,
which costs shall be determined based on FTE Costs, unless another
basis is otherwise agreed upon by the Parties in writing; and
(b) all [*] costs and expenses incurred in performing R&D
Plan activities, including payments to investigators, contract
research organizations, and consultants, for preclinical studies,
pharmacodynamic or pharmacokinetic studies, molecular biology,
toxicology studies, data management, statistical design,
programming and analysis, clinical studies, clinical trial
management, document preparation and review, subject recruitment
and reimbursement, insurance, contract negotiation and travel;
(c) all [*] fees and costs incurred in connection with the
preparation, filing and submission of INDs, BLAs and other
regulatory filings with Regulatory Authorities for Collaboration
Products (including pharmacoeconomic studies and any other clinical
studies reasonably necessary for Regulatory Approval by relevant
Regulatory Authorities to sell such Collaboration Product in each
country);
(d) subject to reduction under Section 7.4.2 hereof, [*]
costs incurred after the Effective Date and directly attributed to
the Collaboration under any Third Party licenses based on the
intellectual property rights of such Third Parties (i) entered
into prior to the Effective Date and disclosed to the other Party
prior to the Effective Date or (ii) entered into after written
agreement by the JRDC in accordance with Section 2.7;
(e) [*] costs and expenses relating to clinical supplies, lab
supplies, animals and other direct charges incurred in performing
R&D Plan activities as set forth in the R&D Plan,
including: (i) costs and expenses incurred to purchase and/or
package comparator or combination drugs or devices; and
(ii) costs and expenses of disposal of clinical samples;
(f) [*]; and
(g) any other costs incurred that are specifically included in
the budget for such R&D Plan.
1.80 " R&D Plan " means the plan relating to a
particular Collaboration Target for each Contract Year prepared,
developed and approved in accordance with Section 2.2.5 or
Section 4.2.1, as applicable. An outline of the tasks to be
considered for inclusion in each R&D Plan is set forth in
Schedule 1.80 .
1.81 " R&D Program " means the Research and
Development activities relating to a particular Collaboration
Target and to be conducted in accordance with an applicable R&D
Plan.
1.82 " Receiving Party " has the meaning specified in
Section 1.24 hereof.
1.83 " Regulatory Approval " means any and all approvals
(including any applicable governmental price and reimbursement
approvals), licenses, registrations, or authorizations of any
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federal, national, multinational, state,
provincial or local regulatory agency, department bureau or other
governmental entity that are necessary for the manufacture, use,
storage, import, transport, promotion, marketing and sale of a
Collaboration Product in the Field in a country or group of
countries.
1.84 " Regulatory Authority " means any governmental
authority in a country or region that regulates the manufacture or
sale of pharmaceutical products, including the FDA and the EMEA,
and any successors thereto.
1.85 " Relevant Third Party IP " has the meaning
specified in Section 11.2.8 hereof.
1.86 " Representatives " has the meaning specified in
Section 3.8.2.2 hereof.
1.87 " Research and Development " means the conduct of
activities relating to the discovery of Antibodies for
Collaboration Targets, the identification, characterization,
selection, optimization and research of Program Antibodies and
Collaboration Products and the conduct of all tests, clinical and
other studies and other activities (including test method
development, toxicology studies, statistical analysis and report
writing, preclinical and other testing, packaging and regulatory
affairs, product approval and registration activities) set forth
in, or required to obtain the information set forth in, applicable
R&D Plan(s). Research and Development may include without
limitation (a) the discovery of Program Antibodies that
selectively bind to and act through Collaboration Targets,
(b) the development of assays for Program Antibodies to, inter
alia, confirm the activity of such Program Antibodies or
Collaboration Target, (c) if applicable, the Human
Engineering™ of non-human Antibodies that selectively bind to
and act through such Collaboration Target, and (d) the
performance of affinity maturation on such Program Antibodies, in
each case with the objective of identifying Program Antibodies that
meet the criteria for designation as Collaboration Products. Such
criteria for the initial Collaboration Target referred to in
Section 2.2.1 are set forth on Schedule 2.2.1, and criteria
for any Proposed Target shall be agreed upon between the Parties as
a part of the initial R&D Plan prepared pursuant to
Section 2.2.5.
1.88 " Specifications " means, with respect to any
Collaboration Product, the applicable written specifications for
such Collaboration Product in effect at a particular time
including, but not limited to, specifications provided in any
Regulatory Approval for such Collaboration Product.
1.89 " Subsequent Lead Antibody " has a meaning specified
in Section 7.3.4(b) hereof.
1.90 " Takeda Background Technology " means any and all
Know-How and Patent Rights Controlled by Takeda as of the Effective
Date [*] and, in particular, any such Patent Rights and Know-How
Covering any Collaboration Target, Program Antibody or
Collaboration Product, for purposes of conducting Research and
Development or Manufacturing activities in connection with the
Collaboration. For the avoidance of doubt, the Parties acknowledge
that, to the extent any Takeda Background Technology is covered by
a license or other agreement with a Third Party, such Takeda
Background Technology shall, for all purposes of this Agreement, be
subject to the limitations, restrictions and financial obligations
established in such Third Party license or agreement, with Takeda
being responsible for the payment of all payments due
thereunder.
1.91 " Target " means a gene and the products encoded by
such gene, including, without limitation, [*].
1.92 " Territory " means all of the countries and
territories of the world.
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1.93 " Third Party " means any person or
entity other than Takeda, XOMA and their respective
Affiliates.
1.94 " Valid Claim " means either (a) a claim of an
issued and unexpired patent which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal and that is not
admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise, or (b) a claim of a pending parent patent
application that has not been abandoned or finally rejected without
the possibility of appeal or refiling.
1.95 " XOMA Background Technology " means any and all
Know-How and Patent Rights owned by XOMA as of the Effective Date
[*] and, in particular, any such Patent Rights and Know-How
Covering any Collaboration Target, Program Antibody or
Collaboration Product, that are necessary for (a) research
related to Collaboration Target(s) or (b) Research and
Development, Manufacture or commercialization of Program
Antibody(ies) or Collaboration Product(s). For the avoidance of
doubt, the Parties acknowledge that, to the extent any XOMA
Background Technology is covered by a license or other agreement
with a Third Party, such XOMA Background Technology shall, for all
purposes of this Agreement, be subject to the limitations,
restrictions and financial obligations established in such Third
Party license or agreement, with Takeda being responsible for
payment of the portion of the financial obligations related to this
Agreement arising as a result of the Collaboration, subject to
Section 7.4.2. XOMA Background Technology excludes the Human
Engineering™ Technology.
ARTICLE 2
COLLABORATION OVERVIEW
2.1 General .
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2.1.1 Objectives . The Parties intend to carry out one or
more programs in which Takeda and XOMA will collaborate to identify
and characterize Program Antibodies and to carry out the Research
and Development and Manufacturing of Antibody Products that act
through Collaboration Targets for use in the Field (the "
Collaboration "), consistent with the objectives set forth
in the applicable Plan(s). It is intended that the Collaboration
will be conducted as a unified collaborative effort with activities
by the Parties carried out primarily at each Party’s
respective facilities, and this intent shall be reflected in the
applicable Plan(s).
2.1.2 Program Term . Subject to the termination right
under Section 13.2, each R&D Program shall have its own
term, which will commence on the date the R&D Program is
initiated and shall continue until XOMA completes transfer to
Takeda of and Takeda assumes full responsibility for the relevant
Collaboration Product(s) in accordance with the applicable R&D
Plan(s) (each, a " Program Term "). A detailed schedule for
each R&D Program will be provided in the R&D Plan for such
R&D Program. Notwithstanding Section 13.2, Takeda may
suspend or terminate any given R&D Program at any of the
scheduled research milestones mentioned in the R&D Plan for
such R&D Program in the event that Takeda reasonably judges
that it is not commercially feasible to pursue further such R&D
Program based on the data and information then available with
regard to such R&D Program, subject to XOMA’s rights
under Section 13.6. In no event shall XOMA be obligated,
without its prior approval, to carry out activities relating to an
R&D Program beyond those listed in Section 4.1 or
otherwise reasonably anticipated to be performed in view of the
R&D Plan for such Collaboration Target.
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2.1.3.3 In case XOMA does not complete the
activities assigned to it pursuant to the applicable R&D Plan
within the [*] term limitation on XOMA’s work on the
Collaboration Target(s) mentioned in Section 2.1.3.2, upon the
written request of Takeda, XOMA shall deliver to Takeda any results
obtained by it during the course of the related R&D Program as
soon as reasonably practicable following such request. In case
(a) the activities assigned to XOMA in the R&D Plan for
the relevant R&D Program are consistent in scope with those
specified in Schedule 1.80, (b) the Parties reasonably expect
that XOMA’s activities pursuant to such R&D Plan will be
completed within [*] after initiation of such R&D Program,
unless the Parties otherwise agree, and (c) notwithstanding
such expectation, XOMA does not complete the activities assigned to
it pursuant to the applicable R&D Plan within the [*] term
limitation, then (i) upon the written request of Takeda, XOMA
shall grant (subject to any Pre-existing Obligations) any rights
Controlled by XOMA necessary to permit Takeda to continue such
R&D Program by itself or with any Affiliates and/or Third Party
after the [*] term limitation, and (ii) in such event, Takeda
will be obligated to pay the fees, milestones and/or royalty under
this Agreement with respect to any Antibody Product resulting from
such R&D Program, reduced by an amount to be negotiated in good
faith by the Parties to reflect the amount of work originally
assigned in the original R&D Plan to, but not completed by,
XOMA as a percentage of the total amount of work assigned to XOMA
in the applicable R&D Plan, [provided that, without prejudice
to the Parties’ ability to agree on a higher percentage, in
the event XOMA completes the following activities, XOMA shall be
deemed, for purposes of determining the foregoing reduction, to
have completed not less than the corresponding percentage of the
total amount of work assigned to it:
(A) identification/discovery of a Program Antibody that Takeda
selects for affinity maturation: [*]%; (B) delivery of a
Program Antibody that meets the success criteria established at the
initiation of the related R&D Plan with or without affinity
maturation: [*]%; (C) successful establishment of a Master
Cell Bank: [*]%; and (D) completion of the R&D Program
including Manufacturing activities provided in the relevant Plan,
whether performed hereunder or under a similar arrangement for
Manufacturing: [*]%. In the event XOMA does not provide Takeda with
any Program Antibody that Takeda elects to continue to develop with
respect to a Collaboration Target, Takeda will not be obligated to
pay the fees, milestones and/or royalty under this Agreement with
respect thereto and Takeda shall not be granted any rights pursuant
to (i) above with respect to such Collaboration Target. In
such case, Takeda will not owe any obligations hereunder as to such
Collaboration Target and conduct its research activities on such
Collaboration Target freely from any restrictions hereunder. The
Parties agree that the continued applicability of the [*] term
limitation, if any, will not be a factor determining acceptance or
rejection of a Proposed Target, regardless of when during the time
period set forth in 2.2.2 such Proposed Target is
submitted].
2.2 Selection of Collaboration Targets .
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2.2.1 Initial Collaboration Target . Takeda has
designated [*], the definition of which is provided in the initial
R&D Plan, as the initial Collaboration Target, and XOMA has
accepted such Target into the Collaboration, thereby making it a
Collaboration Target and the subject of the first R&D Program.
The initial R&D Plan for [*] is attached hereto as Schedule
2.2.1 . The parties agree that the initial R&D Plan for [*]
may be adjusted upon mutual agreement between XOMA and Takeda based
on the results of tests on [*] described in the initial R&D
Plan for [*] which Takeda intends to perform, such tests being
scheduled to be completed within [*] of the Effective Date.
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In the event Takeda concludes that it does not
wish [*] to be the initial Collaboration Target based on the
scheduled tests and so notifies XOMA within [*] of the Effective
Date, Takeda may replace [*] with the Target coded by Takeda as [*]
as the initial Collaboration Target without any additional payments
or obligations to XOMA under Section 7.1.
If Takeda replaces [*] with [*] as the initial Collaboration
Target, any data and information, including any discoveries and
inventions, if any, relating to [*], that are disclosed to XOMA by
Takeda or obtained by XOMA based on the data and information
disclosed by Takeda shall be returned to Takeda, and thereafter,
XOMA shall not be deemed to have received or been granted any
rights or interests belonging to Takeda in [*] by virtue of this
Agreement. For the avoidance of doubt, not only the test results
but also the fact that Takeda withdrew [*] shall be Confidential
Information and subject to the confidentiality obligations placed
upon XOMA hereunder.
If Takeda decides to continue the Collaboration on [*], upon the
request of Takeda, any information or data regarding [*] disclosed
by Takeda to XOMA shall be returned to Takeda and XOMA shall not be
deemed to have obtained or been granted any rights belonging to
Takeda in [*] by virtue of this Agreement. In addition, the fact
that Takeda named [*] as an alternate Collaboration Target shall be
Confidential Information and subject to the confidentiality
obligations placed upon XOMA hereunder.
2.2.2 Proposal of Additional Targets . As used herein, "
Proposed Targets " means Targets identified and validated by
Takeda as having potential application in the Field and which are
to be considered as candidates for Collaboration Targets. During
the period [*], Takeda may request XOMA’s consent (which
consent shall not be unreasonably withheld or delayed) to submit
additional Proposed Targets to the Escrow Agent, for consideration
as proposed Collaboration Targets by sending the form attached
hereto as Schedule 2.2.2 . Takeda shall have no obligation
to submit any particular Target for consideration as a Proposed
Target.
2.2.3 Exclusion of Targets from Consideration . Upon
receipt of XOMA’s written consent as provided in
Section 2.2.2, Takeda shall submit the identity of each
Proposed Target, by sending the form attached hereto as Schedule
2.2.3 , to the Escrow Agent in confidence for comparison
against XOMA’s list of Excluded Targets, which XOMA may
update from time to time. In the event such Proposed Target matches
any Excluded Target on such list, the Escrow Agent shall promptly
so notify each Party in writing. In the event the Proposed Target
does not match any Excluded Target, the Escrow Agent shall promptly
so notify each Party in writing and Takeda shall disclose the
identity of the Proposed Target to XOMA. For the avoidance of
doubt, under no circumstances shall the Escrow Agent disclose the
identity of the Proposed Target to XOMA. All reasonable fees and
expenses of the Escrow Agent incurred in the performance of
services under this Section 2.2.3 shall be borne by
Takeda.
2.2.4 Disclosure of Additional Information . In the event
the Escrow Agent notifies the Parties that a Proposed Target does
not match any Excluded Target, Takeda shall promptly disclose to
XOMA, [*].
All data, information and conclusions reduced to writing and
delivered by Takeda to XOMA pursuant to this Section 2.2.4
shall be deemed Confidential Information of Takeda, subject to the
exceptions in Section 1.24.
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2.3 Conduct of Collaboration .
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2.3.1 Efforts . Each Party shall use Commercially
Reasonable and Diligent Efforts to conduct the activities of the
Collaboration that are assigned to it in the then-applicable
Plan(s), and each shall devote sufficient resources to carry out
such respective activities.
2.3.2 Resources . Over the course of the Collaboration,
tasks will be allocated between the Parties in the best interest of
the Collaboration. The Parties agree to commit to the Collaboration
the personnel necessary to meet their respective responsibilities
set forth in each Plan.
2.3.3 Subcontractors . As necessary and in furtherance of
the Collaboration, either Party may enter into Research and
Development-related agreements or subcontracts in accordance with
this Section 2.3.3; [*].
2.3.4 Reports . During the Program Term but prior to
filing of an IND for a Collaboration Product, each Party shall
submit written quarterly reports to the Joint Steering Committee
for each Collaboration Target, as may be required by the
then-current Plan(s), detailing its activities under the
Collaboration. During the Program Term and after the filing of an
IND for a Collaboration Product, Takeda shall provide to XOMA at
least once per calendar year, or more frequently as reasonably
necessary for XOMA or Takeda to comply with their respective
obligations to Third Parties, a summary of Takeda’s
activities relating to Program Antibodies and Collaboration
Products.
2.3.5 Visiting . During the Program Term, Takeda may
request that XOMA permit Takeda’s representative to visit
XOMA’s research facility in order to review the progress of
an R&D Program. XOMA’s consent to such request shall not
be unreasonably withheld or delayed. Takeda shall pay all the
reasonable costs for such visit incurred by XOMA. The
representative
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visiting XOMA’s facility shall comply with
all of XOMA’s applicable policies, procedures and legal and
contractual requirements that are disclosed and explained to such
representatives beforehand by XOMA in the course of such visit, and
Takeda shall be liable for any breach thereof by its
representative.
2.4 Collaboration Records . In order to protect the
Parties’ Patent Rights and Know-How under U.S. law in respect
of any inventions conceived or reduced to practice during or as a
result of the Collaboration, each Party agrees to maintain a policy
that requires its employees to record and maintain all data and
information developed during the Collaboration in such a manner as
to enable the Parties to use such records to establish the earliest
date of invention and/or diligence to reduction to practice. At a
minimum, the policy shall require such individuals to record all
inventions generated by them in standard laboratory notebooks or
other suitable means that are dated and corroborated by
non-inventors on a regular, contemporaneous basis.
2.5 Disclosure of Collaboration Results . Subject to
restrictions imposed by a Party’s confidentiality obligations
to any Third Party with respect to Takeda Background Technology or
XOMA Background Technology, each Party will disclose to the JRDC
and to the Joint Patent Committee all Program Technology and
Program Materials that are discovered, invented or made by such
Party in the course of the Collaboration and that are useful in or
relate to the Collaboration, including without limitation
information regarding Collaboration Targets, Program Antibodies and
Collaboration Products and uses thereof and the results of all
Research and Development studies. Such Program Technology and
Program Materials will be promptly disclosed to the JRDC and to the
Joint Patent Committee, with meaningful discoveries or advances
being communicated as promptly as practicable after such
information is obtained or its significance is appreciated. [*].
Any information disclosed pursuant to this Section 2.5 may be
used by the other Party solely for the purposes of the
Collaboration or as otherwise expressly permitted in this
Agreement.
2.6 Material Transfer . Any Program Materials useful or
necessary for the R&D Program that are first derived or
obtained in the course of the Collaboration and that are specific,
as opposed to being of general applicability, to a Collaboration
Target or a Program Antibody shall be delivered and assigned from
XOMA to Takeda in accordance with the Research Plan or otherwise
upon Takeda’s request. Such Program Materials shall become
Takeda’s sole property but, if applicable, subject to the
Pre-existing Obligations. For the avoidance of doubt,
notwithstanding anything herein to the contrary, such Program
Materials shall include any and all Program Antibodies themselves
(including any rights and interests in a Master Cell Bank
established therefor), which shall consequently be delivered and
assigned from XOMA to Takeda as described above. Any and all
Program Materials useful or necessary for the R&D Program that
are first derived or obtained in the course of the Collaboration
and that are of general applicability, as opposed to being
specific, to a Collaboration Target or a Program Antibody shall
also be delivered (but shall not be assigned) from XOMA to Takeda
for its use permitted under this Agreement, regardless of the
ownership thereof (which shall be as determined under
Section 9.1.2 hereof), provided, that XOMA may retain
such quantities of such Program Materials as are reasonably
necessary for use by XOMA in accordance with Section 9.1.3.1.
The Parties will use Commercially Reasonable and Diligent Efforts
to specify in the applicable R&D Plan the quantities of such
Program Materials to be so retained by XOMA, recognizing that the
Parties’ primary objective with respect to such Program
Materials in the context of such R&D Plan shall be to meet
Takeda’s requirements with respect thereto.
Furthermore, in order to facilitate the Collaboration, either
Party may provide to the other Party certain Program Materials not
derived or obtained during the course of Collaboration for use by
the other Party in furtherance of the Collaboration. The Parties
hereto shall cooperate with each other for proper
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identification and maintenance of the Program
Materials provided hereunder by providing the receiving Party with
certificate(s) of analysis, where applicable, and keeping records
of exchange and, where feasible, using the same identification
code(s). All such Program Materials shall be considered the
Confidential Information of both Parties and shall be subject to
the restrictions in Article 10. Except as otherwise provided
under this Agreement or in accordance with the applicable Plan(s),
all such Program Materials delivered to the other Party voluntarily
shall remain the sole property of the supplying Party, shall be
used only in furtherance of the Collaboration and solely under the
control of the other Party and its Affiliates, shall not be used or
delivered to or for the benefit of any Third Party without the
prior written consent of the supplying Party and shall not be used
in research or testing involving human subjects, in each case
except as may be provided in the applicable R&D Plan. The
Program Materials supplied under this Section 2.6 must be used
with prudence and appropriate caution in any experimental work,
since not all of their characteristics may be known. THE PROGRAM
MATERIALS ARE PROVIDED "AS IS" AND WITHOUT ANY REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY
PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS
WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS
OF ANY THIRD PARTY. The Party providing the Program Materials shall
disclose to the other Party such information as is in the Providing
Party’s possession and can reasonably be disclosed regarding
such Program Materials including, where feasible, its identity,
scientific nature, safety, safe handling, related patents or any
other proprietary rights of a Third Party that are known to the
providing Party.
2.7 [*]
ARTICLE 3
COLLABORATION MANAGEMENT
3.1 Collaboration Committees .
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3.1.1 Joint Steering Committee . As soon as practicable
after the Effective Date, XOMA and Takeda shall establish a Joint
Steering Committee (the " Joint Steering Committee ")
comprised of three (3) representatives designated by each of
XOMA and Takeda, each of whom shall have experience and seniority
sufficient to enable him or her to make decisions on behalf of the
Party he or she represents within the scope of the responsibilities
of the Joint Steering Committee as provided herein.
3.1.2 Joint Research and Development Committee . As soon
as practicable after the Effective Date, XOMA and Takeda shall
establish a Joint Research and Development Committee (the "
JRDC ") comprised of three (3) representatives
designated by each of XOMA and Takeda, each of whom shall have
experience and seniority sufficient to enable him or her to make
decisions on behalf of the Party he or she represents within the
scope of the responsibilities of the JRDC as provided herein. From
time to time during the Program Term, the JRDC may establish one or
more Joint Project Teams (each, a " Joint Project Team ") to
implement various aspects of any R&D Plan. Such teams shall be
governed in the same manner and subject to the relevant
requirements as set forth herein for the JRDC.
3.1.3 Joint Patent Committee . As soon as practicable
after the Effective Date, XOMA and T
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