Exhibit 10.24C
AMENDED AND
RESTATED
RESEARCH, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
This Amended and Restated Research,
Development and Collaboration Agreement (this “
Agreement ”) is effective as of July 1, 2008 (the
“ Effective Date ”) by and between Novartis
Vaccines and Diagnostics, Inc. (f/k/a Chiron Corporation), a
Delaware corporation with offices at 4650 Horton Street,
Emeryville, California 94608 (together with its Affiliates, “
NVDI ”), and XOMA (US) LLC, a Delaware limited
liability company with offices at 2910 Seventh Street, Berkeley,
California 94710 (together with its Affiliates, “ XOMA
”). NVDI and XOMA are sometimes referred to herein
individually as a “ Party ” and collectively as
the “ Parties .” When used in this Agreement,
capitalized terms shall have the meanings set forth in Article
1.
RECITALS
1. The Parties established a
collaborative relationship to research, develop and commercialize
antibody products in the field of oncology pursuant to that certain
agreement executed on February 27, 2004 by and between the
Parties (the “Initial Agreement” ).
2. The Parties entered into that
certain Research, Development and Commercialization Agreement dated
as of May 26, 2005 (the “Original
Agreement” ) to replace the Initial Agreement to set
forth in further detail the terms of the collaborative relationship
between the Parties.
3. The Parties now wish to amend and
restate the Original Agreement on the terms set forth
below.
IN CONSIDERATION of the mutual
covenants and agreements contained in this Agreement, and for other
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties hereby agree as
follows:
ARTICLE 1
DEFINITIONS
The following terms shall have the
following meanings as used in this Agreement:
1.1 “Accounting
Standards” means
(a) with respect to NVDI, International Financial Reporting
Standards, and (b) with respect to XOMA, United States
generally accepted accounting principles, in each case consistently
applied and as in effect from time to time.
1.2
“Affiliate” means any entity that is controlled by, controls
or is under common control with NVDI or XOMA, as applicable. For
such purpose, the term “ control ” means
(a) direct or indirect ownership of more than fifty percent
(50%) of the voting interest in the entity in question, or
more than fifty percent (50%) interest in the income of the
entity in question; or (b) possession, directly or indirectly,
of the power to direct or cause the direction of management or
policies of the entity in question (whether through ownership of
securities or other ownership interests, by contract or
otherwise).
1.3 “Agreement
Product” means any
of the Collaboration Products, Resumed Products, Reactivated
Products and Ongoing Products.
1.4 “Agreement
Target” means each
of the Targets in the Original Collaboration immediately prior to
the Effective Date as set forth on Schedule 1.4 .
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 alone or 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. For the avoidance of doubt, Antibody Product does not
include gene therapy products, Fc fusion proteins lacking antibody
variable domains or viral conjugates.
1.7 “BLA”
means a biologics license
application with the FDA as more fully described at 21 CFR §
601.2, or successor equivalent.
1.8 “Collaboration
Inventions” means
any and all Inventions Controlled by a Party and made, conceived,
reduced to practice or otherwise acquired or licensed, either alone
or jointly with another, on or after the Effective Date of the
Initial Agreement and before the Effective Date and arising out of
the activities of the Parties under the Original Collaboration and
pursuant to research and development plans and budgets approved
under the Initial Agreement or the Original Agreement, excluding,
however, any and all Inventions encompassed within the Expression
and Engineering Technologies. For the avoidance of doubt,
(a) any and all such Inventions which constitute an
improvement to either NVDI Background IP or XOMA Background IP
made, conceived, reduced to practice or otherwise acquired or
licensed on or after the Effective Date of the Initial Agreement
and before the Effective Date and in the course of the Original
Collaboration shall be deemed to be Collaboration Inventions, and
(b) any and all Inventions made, conceived, reduced to
practice or otherwise acquired or licensed on or after the
Effective Date shall not be Collaboration Inventions.
Notwithstanding the foregoing, the Parties acknowledge that, to the
extent any Collaboration Invention is covered by a license or other
agreement with a Third Party, such Collaboration Invention shall,
for all purposes of this Agreement, be subject to the financial and
other obligations, limitations and restrictions contained in such
Third Party license or agreement.
1.9 “Collaboration
IP” means any and
all Collaboration Know-How and any and all Collaboration Patent
Rights.
1.10 “Collaboration
Know-How” means any
and all Know-How Controlled by a Party and made, conceived, reduced
to practice or otherwise acquired or licensed, either alone or
jointly with others, on or after the Effective Date of the Initial
Agreement and before the Effective Date and arising out of the
activities of the Parties under the Original Collaboration
and
pursuant to research and development
plans and budgets approved under the Initial Agreement or the
Original Agreement that is necessary or useful in the research,
development, manufacture or commercialization of a Collaboration
Product, excluding, however, any and all Know-How encompassed
within the Expression and Engineering Technologies. For the
avoidance of doubt, (a) any and all such Know-How which
constitutes an improvement to either NVDI Background IP or XOMA
Background IP made, conceived, reduced to practice or otherwise
acquired or licensed on or after the Effective Date of the Initial
Agreement and before the Effective Date and in the course of the
Original Collaboration shall be deemed to be Collaboration
Know-How, and (b) any and all Know-How made, conceived,
reduced to practice or otherwise acquired or licensed on or after
the Effective Date shall not be Collaboration Know-How.
Notwithstanding the foregoing, the Parties acknowledge that, to the
extent any Collaboration Know-How is covered by a license or other
agreement with a Third Party, such Collaboration Know-How shall,
for all purposes of this Agreement, be subject to the financial and
other obligations, limitations and restrictions contained in such
Third Party license or agreement.
1.11 “Collaboration Patent
Rights” means
Patent Rights claiming Collaboration Inventions.
1.12 “Collaboration
Product” means any
Antibody Product that: (a) binds to CD40 or [*] and
(b) is identified, generated or otherwise created, or acquired
from a Third Party, by either Party before or after the Effective
Date, provided, however, that such Antibody Product shall
cease to be a Collaboration Product when the Target it binds to
becomes a Pending Target pursuant to Section 2.1(d)(i), and
provided, further that, if such Target again becomes a
Collaboration Target pursuant to Section 2.1(d)(ii), such
Antibody Product, as well as any other Antibody Product that binds
to the same Target and that has been, or is later, identified,
generated or otherwise created, or acquired from a Third Party by
either Party at any time, shall again become a Collaboration
Product.
1.13 “Collaboration
Target” means each
of CD40 and [*] unless or until either or both of such Targets
become Pending Targets pursuant to Section 2.1(d)(i), but
subject to either or both of such Targets again becoming
Collaboration Targets pursuant to
Section 2.1(d)(ii).
1.14 “Commercially
Reasonable and Diligent Efforts” means, with respect to the efforts to be
expended by a Party hereunder, efforts and resources comparable to
those used by the Top 10 Pharmaceutical Companies (with respect to
NVDI), or an appropriately funded biotechnology company of
comparable market capitalization (with respect to XOMA) as would
reasonably be expected to be exerted or employed for a product
proprietary to that company, which product is of similar market
potential (taking into account the relevant patent and proprietary
position) at a similar stage in its development or product life to
the applicable Target, Antibody or Antibody Product (or another
comparable product if no such Antibody Product exists), utilizing
sound and reasonable scientific, business, (where relevant)
pre-clinical and clinical practice and judgment in order to develop
and commercialize such product in a timely manner. A Party’s
obligation to devote Commercially Reasonable Efforts may be
satisfied by that Party’s or its Affiliate’s efforts.)
Notwithstanding the foregoing, to the extent that the performance
of a Party’s responsibilities hereunder is adversely affected
by the other Party’s failure to perform its responsibilities
hereunder, such Party shall not be deemed to have failed to use
Commercially Reasonable and Diligent Efforts in performing such
responsibilities.
1.15 [*]
1.16 “Confidential
Information” means
all know-how, inventions, technical, marketing, financial or other
similar information, including without limitation proprietary
information and biological and other tangible materials (whether or
not patentable). Materials, know-how or other information that is
orally, electronically or visually disclosed by a Party, or is
disclosed in writing without an appropriate letter, stamp or
legend, shall constitute Confidential Information if such
information is of the type that should reasonably have been
considered confidential by the receiving Party at the time of
disclosure, given the circumstances surrounding the disclosure of
such materials, know-how or other information.
1.17
“Control” or
“Controlled” means, with respect to any Know-How
or Patent Rights, possession of the ability (whether arising by
ownership or license) to grant rights, ownership, access, a license
or a sublicense (as applicable) to such intellectual property as
provided for herein without violating the terms of any written
agreement with a Third Party entered into prior to the time such
Party would be first required hereunder to grant the other Party
such access, license or sublicense.
1.18 “Controlling
Party” means
(a) with respect to Collaboration Inventions and
Post-Effective Date Inventions made, conceived or reduced to
practice in the course of a Collaboration Project or in the course
of developing or commercializing a Collaboration Product, and all
Collaboration Patent Rights and Post-Effective Date Patent Rights
covering or claiming any such Invention(s), NVDI, (b) with
respect to Collaboration Inventions and Post-Effective Date
Inventions made, conceived or reduced to practice in the course of
a Resumed Project or in the course of developing or commercializing
a Resumed Product, and all Collaboration Patent Rights and
Post-Effective Date Patent Rights covering or claiming any such
Invention(s), XOMA, (c) with respect to Collaboration
Inventions and Post-Effective Date Inventions made, conceived or
reduced to practice in the course of a Reactivated Project or an
Ongoing Project, and all Collaboration Patent Rights and
Post-Effective Date Patent Rights covering or claiming any such
Invention(s), the Party progressing such Reactivated Project or
Ongoing Project, and (d) with respect to Collaboration
Inventions and Post-Effective Date Inventions made, conceived or
reduced to practice in the course of Preliminary Research with
respect to a particular Inactive Project, and all Collaboration
Patent Rights and Post-Effective Date Patent Rights covering or
claiming any such Invention(s), the Party conducting such
Preliminary Research.
1.19 “Effective Date of the
Initial Agreement” means February 27, 2004.
1.20 “Expression and
Engineering Technologies” means (a) the bacterial cell expression
technology Controlled by XOMA Ireland Limited and subsequently
licensed to XOMA (with the right to sublicense hereunder) and any
improvements thereto which are made, conceived, reduced to practice
or otherwise acquired or licensed on or after the Effective Date of
the Initial Agreement and before the Effective Date and in the
course of the Original Collaboration, and (b) the Human
Engineering™ Technology.
1.21 “FDA”
means the United States Food and
Drug Administration and any successor agency.
1.22 “Human Engineering
Technology” means
the Human Engineering™ technology Controlled by XOMA Ireland
Limited and subsequently licensed to XOMA (with the right to
sublicense hereunder) and any improvements thereto which are made,
conceived, reduced to practice or otherwise acquired or licensed on
or after the Effective Date of the Initial Agreement and before the
Effective Date and in the course of the Original
Collaboration.
1.23 “Inactive
Product” means:
(a) in the case where CD40 or [*] is the Inactive Target, an
Antibody Product that is deemed an Inactive Product pursuant to
Section 2.1(d)(iv); (b) in the case where an Inactive
Target becomes a Reactivated Target and later becomes an Inactive
Target again pursuant to Section 2.2(d), an Antibody Product
that is deemed an Inactive Product pursuant to Section 2.2(d);
and (c) in the case of any other Inactive Target, (i) an
Antibody Product that binds to such Inactive Target and that was
initially identified, generated or otherwise created, or acquired
from a Third Party, by either Party in the course of the Original
Collaboration, or (ii) any other Antibody Product that also
binds to such Inactive Target and that is derived from, or derived
from the use of, an Antibody Product referred to in clause
(i) of this sentence.
1.24 “Inactive
Target” means any
Agreement Target that is not subject to a Project. The Inactive
Targets existing as of the Effective Date are set forth on
Schedule 1.24 .
1.25 “IND”
means an investigational new drug
application with the FDA as more fully described at 21 CFR §
312.20, or successor equivalent, or a comparable filing with a
Regulatory Authority outside the United States.
1.26
“Inventions” means any and all inventions, discoveries or
ideas, and improvements thereto (whether or not
patentable).
1.27
“Know-How” means any and all know-how, trade secrets, data,
processes, techniques, procedures, compositions, materials,
devices, methods, formulas, protocols, pre-clinical 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.
1.28 “Net
Sales” means the
gross invoice price of Products sold by or on behalf of NVDI (or
its Affiliates or sublicensees) for sale of Collaboration Products,
NVDI Ongoing Products and NVDI Reactivated Products, or XOMA (or
its Affiliates or sublicensees) for sale of Resumed Products, XOMA
Ongoing Products and XOMA Reactivated Products, as the case may be
(each, a “ Selling Entity ”), in each case to
Third Parties, in bona fide, arms-length transactions after
deduction of all of the following (reasonably
documented):
(a) [*]
all as determined in accordance with
the Selling Entity’s usual and customary Accounting Standards
as consistently applied by the Selling Entity.
Amounts invoiced between a Selling
Entity and its Affiliates for quantities of Product for use in
clinical trials or for resale, or by a Selling Entity or its
Affiliates to permitted sublicensees of the license(s) granted
hereunder for resale shall not be included in the calculation of
Net Sales.
Any of the items set forth above
that would otherwise be deducted from the invoice price in the
calculation of Net Sales but which are separately charged to Third
Parties shall not be deducted from the invoice price in the
calculation of Net Sales.
Net Sales of any Product sold by or
on behalf of a Selling Entity or its Affiliates as part of a
product that in addition to Product contains one or more other
active ingredients (a “Combination Product”), shall be
calculated as follows:
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(1)
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The Net Sales
for the purpose of determining royalty-style payments on sales of
the Combination Product shall be calculated by [*].
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1.29 “NVDI Background
IP” means any and
all Know-How and Patent Rights (including, for example,
intellectual property relating to Agreement Targets) Controlled by
NVDI as of the Effective Date of the Initial Agreement (or, in the
case of intellectual property relating to Agreement Targets
accepted for inclusion in the Original Collaboration pursuant to
Section 3.3(d) of the Original Agreement after the Effective
Date of the Initial Agreement, as of the date on which each such
Agreement Target was so accepted) that are [*] for
(a) research relating to Agreement Target(s) or
(b) research, development, manufacture or commercialization of
Resumed Products, XOMA Ongoing Products or XOMA Reactivated
Products. NVDI Background IP also includes any and all Know-How and
Patent Rights that are necessary for either of the purposes set
forth in clauses (a) and (b) of the immediately preceding
sentence and that came to be Controlled by NVDI after the Effective
Date of the Initial Agreement and either (x) before the
Effective Date but not in the course of the Original Collaboration
or (y) on or after the Effective Date, except (i) to the
extent the inclusion of such Know-How and Patent Rights in NVDI
Background IP would constitute a breach or violation of or a
default under, or would otherwise be inconsistent with, the terms
and provisions of any license or other agreement giving rise to or
governing such Know-How or Patent Rights, and (ii) that, in
the event the inclusion of such Know-How or Patent Rights in NVDI
Background IP would subject either or both of the Parties to
additional financial or other adverse obligations to a Third Party,
such Know-How or Patent Rights shall not be so included in NVDI
Background IP unless the Parties so agree (which agreement shall
not be unreasonably withheld or delayed). For the avoidance of
doubt, the Parties acknowledge that, to the extent any NVDI
Background IP is covered by a license or other agreement with a
Third Party, such NVDI Background IP shall, for all purposes of
this Agreement, be subject to the financial and other obligations,
limitations and restrictions contained in such Third Party license
or agreement. NVDI Background IP shall include, without limitation,
those licenses, patents and patent applications set forth on
Schedule 1.29 .
1.30 “Original
Collaboration” means the collaborative relationship between the
Parties as governed by the Initial Agreement and the Original
Agreement during the period from the Effective Date of the Initial
Agreement through the Effective Date.
1.31 “Patent
Rights” means
(a) unexpired letters patent (including inventor’s
certificates) which have not been held invalid or unenforceable by
a court of competent jurisdiction from which no appeal can be taken
or has been taken within the required time period (and which have
not been admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise, or been abandoned), including without
limitation any substitution, extension, registration, confirmation,
reissue, re-examination, supplementary protection certificates,
confirmation patents, patent of additions, renewal or any like
filing thereof and (b) pending applications for letters patent
which have not been canceled, withdrawn from consideration, finally
determined to be unallowable by the applicable governmental
authority for whatever reason (and from which no appeal is or can
be taken), and/or abandoned, including without limitation any
continuation, division or continuation-in-part thereof and any
provisional applications.
1.32 “Phase I Clinical
Trial” means that
portion of the process seeking Regulatory Approval which provides
for human trials for the purposes of determining toxicity,
metabolism, absorption, elimination and other pharmacological
action, as more fully described at 21 CFR §
312.21(a).
1.33 “Phase II Clinical
Trial” means that
portion of the process seeking Regulatory Approval which provides
for human trials for the purposes of determining dose and
evaluating safety and efficacy in the proposed therapeutic
indication, as more fully described at 21 CFR §
312.21(b).
1.34 “Phase III Clinical
Trial” means that
portion of the process seeking Regulatory Approval which provides
for human trials on sufficient numbers of patients intended for the
purposes of (a) establishing safety and efficacy for an
intended use; and (b) defining warnings, precautions and
adverse reactions in the dosage to be prescribed, as more fully
described at 21 CFR § 312.21(c).
1.35 “Post-Effective Date
Inventions” means
any and all Inventions Controlled by a Party and made, conceived,
reduced to practice or otherwise acquired or licensed, either alone
or jointly with another, on or after the Effective Date and arising
out of the activities of such Party in connection with the
development or commercialization of Collaboration Products, NVDI
Ongoing Products, Resumed Products, XOMA Ongoing Products or
Reactivated Products. For the avoidance of doubt, any and all
Inventions comprising the Expression and Engineering Technologies
as such technologies exist on or after the Effective Date shall not
be Post-Effective Date Inventions. Notwithstanding the foregoing,
the Parties acknowledge that, to the extent any Post-Effective Date
Invention is covered by a license or other agreement with a Third
Party, such Post-Effective Date Invention shall, for all purposes
of this Agreement, be subject to the financial and other
obligations, limitations and restrictions contained in such Third
Party license or agreement.
1.36 “Post-Effective Date
Patent Rights” means Patent Rights claiming or covering
Post-Effective Date Inventions.
1.37
“Project” means any of the Collaboration Projects, Pending
Projects, Resumed Projects, Reactivated Projects or Ongoing
Projects. For clarity, each Project shall consist of research and
development activities relating to a particular Agreement Target
and the Agreement Products corresponding to such Agreement
Target.
1.38 “R&D Plans and
Budgets” means
research and development plans and budgets relating to Agreement
Targets and Agreement Products approved in accordance with the
terms of the Original Agreement, as in effect immediately prior to
the Effective Date.
1.39 “Regulatory
Approval” means any
approvals (including pricing and reimbursement approvals),
licenses, registrations or authorizations of any federal, state or
local regulatory agency, department, bureau or other governmental
entity necessary for the manufacture and sale of any Agreement
Product in a regulatory jurisdiction.
1.40 “Regulatory
Authority” means
any national (e.g., the FDA), supranational (e.g., the European
Medicines Agency), regional, state or local regulatory agency,
department, bureau, commission, council or other governmental
entity in any jurisdiction of the world involved in the granting of
Regulatory Approvals for pharmaceutical products.
1.41 “Royalty-Style Payment
Period” means with
respect to any Collaboration Product, Resumed product, NVDI Ongoing
Product, XOMA Ongoing Product or Reactivated Product, the longer of
(i) the period during which such Product is covered by a Valid
Claim of Related XOMA Patent Rights or Related NVDI Patent Rights
as the case may be or (ii) twenty (20) years from the
launch of such Product on a country-by-country basis.
1.42 [*]
1.43
“Target” means any biological molecule that is believed
to be accessible to an Antibody.
1.44 “Third
Party” means any
person or entity other than NVDI or XOMA or their respective
Affiliates.
1.45 “Top 10 Pharmaceutical
Companies” means
[still to be provided by NVDI] .
1.46 “United
States” or “
U.S. ” means the United States of America, including
its territories and possessions, the District of Columbia and
Puerto Rico.
1.47 “Valid
Claim” means a
claim of an issued Patent Right that has not expired or been
revoked, held invalid or unenforceable by a patent office, court or
other governmental agency of competent jurisdiction in a final and
non-appealable judgment (or a judgment from which no appeal was
taken within the allowable time period).
1.48 “XOMA Background
IP” means any and
all Know-How and Patent Rights (including, for example,
intellectual property relating to Agreement Targets) Controlled by
XOMA as of the Effective Date of the Initial Agreement (or, in the
case of intellectual property relating to Agreement Targets
accepted for inclusion in the Original Collaboration pursuant to
Section 3.3(d) of the Original Agreement after the Effective
Date of the Initial Agreement, as of the date on which each such
Agreement Target was so accepted) that are [*] for
(a) research
relating to Agreement Target(s) or
(b) research, development, manufacture (including expression
vectors and other technology for expression of proteins in
mammalian and other non-bacterial cells) or commercialization of
Collaboration Product(s), NVDI Ongoing Product(s) or NVDI
Reactivated Product(s). XOMA Background IP shall also include any
and all Know-How and Patent Rights that are necessary for either of
the purposes set forth in clauses (a) and (b) of the
immediately preceding sentence and that came to be Controlled by
XOMA on or after the Effective Date of the Initial Agreement and
either (x) before the Effective Date but not in the course of
the Original Collaboration or (y) on or after the Effective
Date, except (i) to the extent the inclusion of such Know-How
and Patent Rights in XOMA Background IP would constitute a breach
or violation of or a default under, or would otherwise be
inconsistent with, the terms and provisions of any license or other
agreement giving rise to or governing such Know-How or Patent
Rights, and (ii) that, in the event the inclusion of such
Know-How or Patent Rights in XOMA Background IP would subject
either or both of the Parties to additional financial or other
adverse obligations to a Third Party, such Know-How or Patent
Rights shall not be so included in XOMA Background IP unless the
Parties so agree (which agreement shall not be unreasonably
withheld or delayed). For the avoidance of doubt, the Parties
acknowledge that, to the extent any XOMA Background IP is covered
by a license or other agreement with a Third Party, such XOMA
Background IP shall, for all purposes of this Agreement, be subject
to the financial and other obligations, limitations and
restrictions contained in such Third Party license or agreement.
XOMA Background IP shall include, without limitation, those
licenses, patents and patent applications set forth on Schedule
1.48 . Notwithstanding any provision of this Agreement to the
contrary, XOMA Background IP shall not include the Expression and
Engineering Technologies.
In addition, the following terms
have the meanings given them in the corresponding Sections of this
Agreement:
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Term
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Section
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Agreement
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Introduction
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Article 10
Disputes
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10.1
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Assignment
Date
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11.1(b)
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Claims
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4.1
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Collaboration
Projects
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2.1(a)
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Coordination
Committee
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2.3(b)
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Effective
Date
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Introduction
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Exclusivity
Period
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2.1(d)(iv)
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Inactive
Project
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2.1(d)(iv)
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Initial
Agreement
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Recitals
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Interest
Period
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3.12
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Interest
Rate
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3.12
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Losses
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8.5(a)
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Match
Period
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2.2(c)(ii)
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Match Right
Period
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2.2(c)(ii)
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NVDI
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Introduction
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NVDI Ongoing
Product
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2.2(c)(i)(B)
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NVDI Ongoing
Project
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2.2(c)(i)(B)
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NVDI Reactivated Product
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2.2(b)
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NVDI Reactivated Project
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2.2(b)
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NVDI Releasees
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4.1
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NVDI Releasors
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4.2
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Ongoing Product
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2.2(c)(i)(B)
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Ongoing Project
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2.2(c)(i)(B)
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Original Agreement
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Recitals
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Party/Parties
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Introduction
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Pending Product
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2.1(d)(i)
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Pending Project
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2.1(d)(i)
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Pending Target
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2.1(d)(i)
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Phase III Decision Point
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2.2(c)(ii)
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Preliminary Research
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2.2(a)
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Proof-of-Concept Data
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2.2(b)
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Reactivated Product
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2.2(b)
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Reactivated Project
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2.2(b)
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Reactivated Target
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2.2(b)
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Related NVDI Patent Rights
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7.2(b)
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Related XOMA Patent Rights
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7.2(c)
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Requesting Party
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2.4
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Resumed Product
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2.1(d)(ii)
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Resumed Project
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2.1(d)(ii)
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Resumed Target
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2.1(d)(ii)
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Responding Party
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2.4
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Secured Note Agreement
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3.1
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Security Agreement
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3.2
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Term
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9.1
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Third Party Background IP Agreements
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3.6(f)
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Third Party Transaction
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2.2(c)(ii)
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Transition Period
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2.1(b)
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Trigger Date
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2.1(d)(ii)
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XOMA
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Introduction
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XOMA Ongoing Product
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2.2(c)(i)(B)
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XOMA Ongoing Project
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2.2(c)(i)(B)
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XOMA Reactivated Product
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2.2(b)
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XOMA Reactivated Project
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2.2(b)
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XOMA Releasees
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4.2
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XOMA Releasors
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4.1
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ARTICLE 2
RESEARCH AND
DEVELOPMENT
2.1 Collaboration Targets;
Resumed Targets.
(a) NVDI Control. XOMA and NVDI have been
conducting research and development activities relating to
Collaboration Targets and Collaboration Products in accordance with
existing R&D Plans and Budgets (the “ Collaboration
Projects ”). Commencing upon the Effective Date, NVDI
will assume complete control over the conduct of the Collaboration
Projects, but in any event consistent with existing protocols and
applicable legal requirements. NVDI shall have the sole
decision-making authority and responsibility, to be exercised at
its sole discretion (subject to its obligations under
Section 2.1(c)), without consultation with XOMA or any other
entity, regarding all development, research, manufacturing,
regulatory, safety, marketing and commercialization activities
related to such Collaboration Products anywhere in the world,
including rights and decision-making authority regarding
involvement by Third Parties. Notwithstanding the foregoing or any
other provision hereof to the contrary, NVDI will inform XOMA in a
timely manner of any correspondence or other communication with any
Regulatory Authority regarding the regulatory status of, or that
otherwise relates to the regulatory process concerning, the cell
line provided by XOMA to NVDI for use in connection with the
Agreement Target known as [*].
(b) Transition Period. For a period of [*]
days following the Effective Date (or until such period is earlier
terminated by agreement of the Parties) (the “ Transition
Period ”), (i) XOMA shall use Commercially
Reasonable and Diligent Efforts, as specifically requested by NVDI
and at NVDI’s expense, to assist in the orderly and timely
transfer of responsibilities and necessary materials to the control
of NVDI in order to give effect to Section 2.1(a), and
(ii) from time to time at NVDI’s sole discretion, NVDI
may (but has no obligation to) propose to XOMA that XOMA assist in
research and/or development activities related to, or provide other
services in connection with, one or more Collaboration Projects.
XOMA will consider such proposal, but has no obligation to
undertake any such activities or to provide any such services. If
NVDI and XOMA agree to have XOMA assist in such activities or
provide such services, then the Parties shall negotiate in good
faith with respect to terms under which XOMA would do so. Within
[*] after the Effective Date, XOMA shall provide to NVDI all
reasonably useful data and information in its possession, which
shall include without limitation production cell lines, cell banks,
production batch records, clinical trial materials, research and
assay reagents, test methods and regulatory submissions, relating
to Collaboration Projects. From time to time at NVDI’s sole
discretion, NVDI may (but shall have no obligation to) propose to
XOMA that XOMA assist in providing information and expertise to
NVDI to assist NVDI in preparing regulatory filings and responding
to Regulatory Authority inquiries regarding INDs and/or BLAs
relating to one or more Collaboration Products [*]. XOMA will
consider any such proposal in good faith, but shall have no
obligation to undertake any such activities or to provide any such
services. If NVDI and XOMA agree to have XOMA assist in such
activities or provide such services, then the Parties shall
negotiate in good faith with respect to terms under which XOMA
would do so. Following the Transition Period, XOMA shall have no
obligation whatsoever under this Agreement to assist or provide any
services to, and following such [*] XOMA shall have no obligation
whatsoever under this Agreement to provide any materials to, NVDI
in connection with the Collaboration Projects.
(c) Diligence. NVDI shall use Commercially
Reasonable and Diligent Efforts in the development and
commercialization of the Collaboration Products.
(i) Without limiting the generality of the
foregoing, NVDI shall use Commercially Reasonable and Diligent
Efforts to achieve each of the following diligence
events:
(ii) [*]
(iii) [*]
(d) XOMA’s Right to Resumed
Products.
(i) In the event NVDI decides not to proceed with
all Collaboration Projects related to the development and/or
commercialization of a particular Collaboration Product, NVDI shall
promptly notify XOMA in writing of such decision, upon which
notification such Collaboration Project(s) shall cease to be
Collaboration Project(s) and shall be deemed “ Pending
Project(s) ”, such Collaboration Product shall cease to
be a Collaboration Product and shall be deemed a “ Pending
Product ”, and the Target that is the subject of such
Project shall cease to be a Collaboration Target and shall be
deemed a “ Pending Target .” In addition, if
NVDI fails to use Commercially Reasonable and Diligent Efforts to
develop and/or commercialize any Collaboration Product(s) with
respect to a particular Collaboration Target, XOMA may notify NVDI
in writing of such failure and NVDI shall have [*] after receiving
such notification to remedy such failure. If NVDI fails to do so
within such [*] (or, if such notice is disputed by NVDI, following
resolution of such dispute in XOMA’s favor), the
Collaboration Project(s) related thereto shall also cease to be
Collaboration Project(s) and shall be deemed “ Pending
Project(s) ”, each Collaboration Product related thereto
shall also cease to be a Collaboration Product and shall be deemed
a “ Pending Product ”, and the Target that is
the subject of such Project shall cease to be a Collaboration
Target and shall be deemed a “ Pending Target
.”
(ii) Within [*] after a Project becomes a Pending
Project (the “ Trigger Date ”), NVDI shall
provide to XOMA all reasonably useful data and information in its
possession, which shall include without limitation production cell
lines, cell banks, production batch records, clinical trial
materials, research and assay reagents, test methods and regulatory
submissions relating to such Pending Project. For a period of [*]
after the Trigger Date, XOMA shall have the exclusive option to
provide NVDI with written notice to assume complete control over
such Pending Project. If XOMA does not exercise such option during
such [*] period then from the expiration of such period until the
end of the Exclusivity Period (as defined in
Section 2.1(d)(iv) below), either Party shall have the option
to provide the other Party with written notice to assume complete
control over such Pending Project. Any such notification by XOMA
shall not be construed as XOMA’s waiving any claims against
NVDI. If NVDI resumes control over such Pending Project, then such
Pending Project shall cease to be a Pending Project and shall again
become a Collaboration Project, each Antibody Product related
thereto shall cease to be a Pending Product and shall again be
deemed a Collaboration Product, the Target that is the subject of
such Project shall cease to be a Pending Target and shall again be
deemed a Collaboration
Target, and the terms and conditions
under this Agreement with respect to a Collaboration Project,
Collaboration Product or Collaboration Target shall again apply
thereto. If XOMA assumes control over such Pending Project, then
such Pending Project shall cease to be a Pending Project and shall
be deemed a “ Resumed Project ”, each Antibody
Product related thereto, including any other Antibody Product that
binds to the same Target and that has been, or is later,
identified, generated or otherwise created, or acquired from a
Third Party by either Party at any time, shall cease to be a
Pending Product and shall be deemed a “ Resumed
Product ”, and the Target that is the subject of such
Project shall cease to be a Pending Target and shall be deemed a
“ Resumed Target ”). XOMA shall thereupon have
the sole decision-making authority and responsibility, to be
exercised at its sole discretion, without consultation with NVDI or
any other entity, regarding all research, development,
manufacturing, regulatory, safety, marketing and commercialization
activities related to such Resumed Project and all Resumed
Product(s) anywhere in the world, including rights and
decision-making authority regarding involvement by Third Parties,
without any further obligation to NVDI, except under
Section 3.6(b).
(iii) If XOMA assumes control over any Project
pursuant to Section 2.1(d)(ii) above, for a period of at least
[*] following receipt of such notice, NVDI shall use Commercially
Reasonable and Diligent Efforts, as specifically requested by XOMA
and at XOMA’s expense, to assist in the orderly and timely
transfer of responsibilities and necessary materials to the control
of XOMA in order to give effect to the last sentence of
Section 2.1(d)(ii), which materials shall include without
limitation production cell lines, cell banks, production batch
records, clinical trial materials, research and assay reagents,
test methods and regulatory submissions relating to such Resumed
Projects. From time to time at XOMA’s sole discretion, XOMA
may (but shall have no obligation to) propose to NVDI that NVDI
assist in research and/or development activities related to, or
provide other services in connection with, the development and/or
commercialization of one or more Resumed Products. NVDI will
consider such proposal in good faith, but shall have no obligation
to undertake any such activities or to provide any such services.
If NVDI and XOMA agree to have NVDI assist in such activities or
provide such services, then the Parties shall negotiate in good
faith with respect to terms under which NVDI would do so. Following
the transition of such Resumed Products to XOMA, NVDI shall have no
obligation whatsoever under this Agreement to assist, or provide
any services or materials to, XOMA in connection with the
development or commercialization of such Resumed
Products.
(iv) Subject to Section 11.1(b), for the
Exclusivity Period (as defined below) with respect to a particular
Pending Project, neither Party shall have the right to develop
and/or commercialize any Antibody Product binding to the applicable
Pending Target, without first assuming control over such Pending
Project pursuant to Section 2.1(d)(ii) above, in which case
such Party shall develop and commercialize such Antibody Product as
a Collaboration Product under such Collaboration Project, or a
Resumed Product under such Resumed Project, as the case may be.
“ Exclusivity Period ” shall mean the period
commencing upon the first Trigger Date with respect to a particular
Pending Project and continuing until the [*] provided that,
(A) if NVDI assumes control over any Pending Project under
Section 2.1(d)(ii) above as a Collaboration Project and later
terminates all development efforts related thereto, so that such
Project again becomes a Pending Project, then the Exclusivity
Period shall commence upon the Trigger Date on which such Project
became a Pending Project for the first time and shall expire upon
[*]
or (B) if XOMA assumes control
over any Pending Project under Section 2.1(d)(ii) above as a
Resumed Project and later terminates all development efforts
thereto, so that such Project again becomes a Pending Project, then
[*]. At the end of the Exclusivity Period for a particular Pending
Project, if neither Party is pursuing such Project as a
Collaboration Project or Resumed Project, then such Pending Project
shall cease to be a Pending Project and shall be deemed an “
Inactive Project ,” the Target that is the subject of
such Project shall cease to be a Pending Target and shall be deemed
an Inactive Target, and (C) each Antibody Product that had
then been identified, generated or otherwise created, or acquired
from a Third Party, by either Party that binds to the relevant
Target, and (D) any other Antibody Product that also binds to
the same Agreement Target and that is derived from, or derived from
the use of, an Antibody Product referred to in clause
(C) above, shall cease to be a Pending Product and be deemed
an Inactive Product.
(v) For clarity, subject to Section 11.1(b),
XOMA shall not have the right to, either by itself or in
collaboration with a Third Party, develop, commercialize and/or
provide related services with respect to any Antibody Product that
binds to any Collaboration Target, and NVDI shall not have the
right to, either by itself or in collaboration with a Third Party,
develop, commercialize and/or provide related services with respect
to any Antibody Product that binds to any Resumed Target.
Otherwise, either Party shall be free, by itself or in
collaboration with a Third Party, to develop, commercialize and/or
provide related services with respect to products that bind to any
of the Agreement Targets, subject to the limitations with respect
to Pending Projects under this Section 2.1(d) and with respect
to Inactive Projects under Section 2.2 below.
2.2 Inactive
Targets.
(a) Activities with Respect to Inactive
Targets .
(i) At any time(s), each Party shall have the right,
at its sole discretion and expense, to perform preclinical research
with respect to any Inactive Target and any Antibody Product
related thereto, until such Party obtains Proof-of-Concept Data
with respect to such Inactive Target (such preclinical research,
the “ Preliminary Research ”). Upon the
reasonable, written request of a Party intending to perform
Preliminary Research with respect to an Inactive Target, the other
Party will provide, at the requesting Party’s expense, any
useful materials in its control relating directly and solely to
such Inactive Target and created during the period from the
Effective Date of the Initial Agreement through the Effective Date
and as part of the Original Collaboration, which materials may
include without limitation production cell lines, cell banks,
production batch records, clinical trial materials, research and
assay reagents, test methods and regulatory submissions relating to
such Inactive Target but shall exclude any materials that the
requesting Party could readily obtain from another source without
undue expense or undue delay to such preclinical
research.
(ii) To the extent a Party has generated during
Preliminary Research, or at any time(s) plans to generate, any new
Antibody Product that binds to any Inactive Target that is not an
Inactive Product, it shall have the right to do so, free and clear
of any obligations to the other Party under this Agreement,
regardless of whether the other Party is pursuing the same
Agreement Target through developing and/or commercializing any
Antibody Product under this Section 2.2 as a Reactivated
Product or an Ongoing Product.
(iii) To the extent a Party elects to further develop
or optimize any Inactive Product, it shall do so pursuant to this
Agreement and in particular the provisions of this
Section 2.2.
(b) Right to Inactive Projects. In the event
that a Party has obtained data from an animal proof-of-principle or
animal proof-of-concept study with respect to any Inactive Product
(the “ Proof-of-Concept Data ”), and intends to
pursue human clinical trials of such Inactive Product, that Party
shall notify the other Party in writing, and provide the other
Party a written description of its Proof-of-Concept Data. Within
[*] after such other Party receives such written notice, subject to
the rest of this Section 2.2(b), such Inactive Product and any
other Inactive Product related to the same Inactive Target shall
cease to be an Inactive Product and shall be deemed a “
Reactivated Product ”, the development and/or
commercialization activities with respect to such Inactive Target
and each Reactivated Product related to such Inactive Target shall
be deemed a “ Reactivated Project ”, and such
Agreement Target shall be deemed a “ Reactivated
Target .” The Party which has first obtained the
Proof-of-Concept Data shall have the exclusive right, as between
the Parties, to further progress such Reactivated Project and to
develop and commercialize each Reactivated Product related thereto,
provided that the other Party shall maintain the right to
develop and/or commercialize products (including Antibody Products)
related to the same Inactive Target provided that such products do
not comprise a Reactivated Product. A Reactivated Project under
development or commercialization by NVDI shall be deemed an “
NVDI Reactivated Project ” and the Reactivated
Product(s) thereunder, “ NVDI Reactivated Product(s)
.” A Reactivated Project under development or
commercialization by XOMA shall be deemed a “ XOMA
Reactivated Project ” and the Reactivated Product(s)
thereunder, “ XOMA Reactivated Product(s) .” If,
upon receiving the notification from the first Party that it has
obtained the Proof-of-Concept Data with respect to a particular
Inactive Product, the other Party claims that it has also obtained
Proof-of Concept Data for an Inactive Product related to the same
Inactive Target, then such other Party shall notify the first Party
in writing within [*] after receiving the notification from the
first Party of such other Party’s claim. In such event, the
Parties shall discuss in good faith to resolve such claim, and
either Party may initiate the dispute resolution procedures set
forth in Article 10 hereof to resolve such claim. The Party which
has been determined by such resolution to have first obtained such
Proof-of-Concept Data with respect to an Inactive Product related
to such Inactive Target shall have the exclusive right, as between
the Parties, to further progress such Project as a Reactivated
Project and to develop and commercialize each Inactive Product
related thereto as a Reactivated Product, pursuant to the terms and
conditions of this Agreement. The Party not progressing any
particular Reactivated Project shall have the match right pursuant
to Section 2.2(c)(ii) below with respect to such Reactivated
Project, and the potential opt-in rights under Sections 2.2(c)(i)
and (iii) below. For clarity, any such opt-in right, if
exercised with respect to any particular Reactivated Project, shall
have the effect only of providing for the Party which made the
opt-in payment to obtain an increased royalty-style payment on the
Net Sales of the Agreement Products related thereto, and shall not
allow such Party to actively participate in the progressing of such
Project or the development and commercialization of such Agreement
Products related thereto.
(c) Opt-In Right and Match
Right .
(i) IND Filing Opt-In
Rights.
(A) If, as a result of any research
and development activities conducted with respect to a Reactivated
Project, the Party advances the development of a Reactivated
Product related thereto such that it has filed an IND for such
Reactivated Product, then such Party shall have the right, but not
the obligation, to offer the other Party the right to opt-in on
such Reactivated Project pursuant to this Section 2.2(c). If
such Party elects to offer the other Party such opt-in right, it
shall provide written notice thereof, together with all reasonably
useful data and information in its possession relating to such
Reactivated Project, including the documentation for the filing of
the IND. The Party receiving the opt-in offer shall have a period
of [*] from the date it receives such notice, data and information
to evaluate such data and information and to exercise its opt-in
rights.
(B) If the Party exercises its
opt-in right, the Party opting-in shall pay the Party who
progressed the Reactivated Project a one-time option fee of [*].
Upon payment of such amount to the Party offering such opt-in
right, the Reactivated Project shall cease to be a Reactivated
Project and shall be deemed an “ Ongoing Project
” and each Reactivated Product related thereto shall cease to
be a Reactivated Product and shall be deemed an “ Ongoing
Product .” Specifically, if NVDI has progressed such
Reactivated Product, such Ongoing Project shall be deemed an
“ NVDI Ongoing Project ” and each Reactivated
Product related thereto, an “ NVDI Ongoing Product
”, and if XOMA has progressed such Reactivated Project, such
Ongoing Project shall be deemed a “ XOMA Ongoing
Project ” and each Reactivated Product related thereto, a
“ XOMA Ongoing Product .” In each case, such
Ongoing Project and Ongoing Product shall be subject to the terms
and conditions set forth in this Agreement applicable to such
Ongoing Project and Ongoing Product including without limitation
the terms and conditions under Sections 2.2(d) and (e), and Article
3.
(C) In the event that the Party
receiving the opt-in offer of this Section 2.2(c) does not
exercise its rights to opt in, the other Party shall be permitted
to progress such Reactivated Project and to research, develop and
commercialize all Reactivated Products related to such Reactivated
Target, either alone or with a Third Party, free of any further
obligation to the other Party under this
Section 2.2.
(ii) Match Right.
With respect to any Reactivated
Project under development by a Party and for which such Party did
not offer the opt-in right to the other Party pursuant to
Section 2.2(c)(i) above, the other Party shall have a Match
Right for such Reactivated Project at any time before the Phase III
Decision Point (the “ Match Right Period ”).
“ Phase III Decision Point ” means the time when
the Party developing such Reactivated Project makes a decision,
after a post-Phase II Clinical Trial meeting with the FDA or
equivalent regulatory authority with respect to a Reactivated
Product related thereto, to conduct a Phase III Clinical Trial with
respect to such Reactivated Product. At any time during the Match
Right Period with respect to such Reactivated Project, if the Party
conducting the development of such Reactivated Project proposes to
license or otherwise grant any development and commercialization
rights to a Third Party with respect to such Reactivated Project or
any Reactivated Product related thereto (a “ Third Party
Transaction ”), then, prior to entering into a binding
agreement with respect to the essential terms of such Third Party
Transaction, such Party shall provide the other Party with written
notice of such terms, together with all reasonably useful
information, including all material information provided to the
Third Party, to the extent such information was
not previously provided to the
receiving Party. The receiving Party shall have the right, in its
sole discretion, to enter into an agreement with the offering Party
on substantially the same terms as those contained in such notice
by providing written notice of such election within thirty
(30) days of receipt of such notice (the “ Match
Period ”), provided that to the extent any of the
material terms of the Third Party Transaction are specific to the
Third Party, its products or business, XOMA and NVDI shall
negotiate in good faith substitute terms which shall provide
equivalent value therefor. In the event that the receiving Party
does not exercise such right within the Match Period, the offering
Party will be free to enter into the Third Party Transaction with
the Third Party on the terms proposed (or on other terms no more
favorable to the Third Party than those offered to the receiving
Party). In the event the offering Party enters into such Third
Party Transaction, such Party shall have no further obligation to
the other Party with respect to such Reactivated Project except as
set forth in Article 3.
(iii) Phase III Decision Point Opt-In Rights.
In the event that the Party conducting the development of a
Reactivated Project: (A) did not offer the opt-in right to the
other Party pursuant to Section 2.2(c)(i) above; (B) did
not enter into any Third Party Transaction with respect to such
Reactivated Project and/or any Reactivated Product related thereto
within the Match Right Period in compliance with
Section 2.2(c)(ii); and (C) has advanced such Reactivated
Project to a Phase III Decision Point, then:
(W) As soon as practicable following
the occurrence of a Phase III Decision Point in respect of a
Reactivated Product related to such Reactivated Project, the Party
progressing such Reactivated Project shall have the obligation to
offer the other Party the right to opt-in on such Reactivated
Project and shall provide written notice thereof, together with all
reasonably useful data and information in its possession relating
to such Reactivated Project, including the memorandum contemplated
by the clause (Z) below, to the other Party.
(X) The Party receiving such notice
shall have a period of [*] from the date it receives such notice,
data, information and memorandum, to evaluate such data,
information and memorandum and to inform the other Party as to
whether it will opt-in on such Reactivated Project. If the Party
exercises its opt-in right, the Party opting-in shall pay the Party
who progressed the Reactivated Project a one-time option fee of
[*]. Upon payment of such amount to the Party offering such opt-in
right, the Reactivated Project shall cease to be a Reactivated
Project and shall be deemed an Ongoing Project, and each
Reactivated Product related thereto shall cease to be a Reactivated
Product and shall be deemed an Ongoing Product, in the same manner
as set forth in Section 2.2(c)(i)(B) above.
(Y) In the event that the Party
receiving opt-in offer of this Section 2.2(c)(iii) does not
exercise its rights to opt in, the other Party shall be permitted
to progress such Reactivated Project and to research, develop and
commercialize all Reactivated Products related to such Reactivated
Target, either alone or with a Third Party, free of any further
obligation to the other Party under this
Section 2.2.
(Z) Such Phase III Decision Point
shall be evidenced by a memorandum to be delivered to the receiving
Party together with a notice delivered pursuant to this
Section 2.2(c)(iii), and such memorandum shall set forth
(1) the rationale for the decision to conduct a Phase III
Clinical Trial with respect to the particular Reactivated Product
related to such
Reactivated Project, (2) the
indication(s) to be pursued in connection with such Phase III, and
(3) the estimated date of the first dosing of the first
patient in such Phase III. In no event shall there occur the first
dosing of the first patient in Phase III prior to delivery of such
memorandum and the expiration of the opt-in rights contemplated by
this Section 2.2(c)(iii)(Z).
(d) Termination of Development Activities .
In the event a Party terminates the development activities with
respect to a Reactivated Project or an Ongoing Project for which
such Party has sole control and responsibility under
Section 2.3 below, such Party shall notify the other Party in
writing, and thereupon such Project shall again become an Inactive
Project, the Target that is the subject of such Project shall again
be deemed an Inactive Target, and each Inactive Product related
thereto shall again be deemed an Inactive Product.
(e) Reactivation of Certain Inactive Projects
. Notwithstanding Section 2.2(b), with respect to each
Inactive Project that was deemed an Inactive Project under
Section 2.1(d)(iv) or Section 2.2(d), either Party may
progress such Inactive Project and conduct further development and
commercialization with respect to the Inactive Products related
thereto by providing the other Party with written notice, upon
which notice such Project shall again become a Reactivated Project
and each such Inactive Product related thereto shall again become a
Reactivated Product, in each case subject again to the applicable
terms under this Agreement and in particular the provisions under
Sections 2.2 and 2.3.
2.3 Parties’
Responsibilities.
(a) NVDI shall have sole control and responsibility
with respect to the research and development of the Agreement
Targets that are the subjects of the Collaboration Projects, NVDI
Reactivated Projects and NVDI Ongoing Projects, and the research,
development, commercialization, regulatory affairs and manufacture
(including clinical and commercial supply) of all Collaboration
Products, NVDI Ongoing Products and NVDI Reactivated Products under
this Agreement, in each case in compliance with all applicable laws
and regulations. XOMA shall have sole control and responsibility
with respect to the research and development of the Agreement
Targets that are the subjects of the Resumed Projects, XOMA
Reactivated Projects and XOMA Ongoing Projects, and the research,
development, commercialization, regulatory affairs and manufacture
(including clinical and commercial supply) of all Resumed Products,
XOMA Ongoing Products and XOMA Reactivated Products under this
Agreement, in each case in compliance with all applicable laws and
regulations.
(b) Without limiting the foregoing, a coordination
committee (the “ Coordination Committee ”) will
be maintained to facilitate the sharing of information and ideas as
reasonably necessary to enable the Parties to meaningfully preserve
and exercise their rights and satisfy their obligations under this
Agreement. The Coordination Committee will be comprised of three
(3) representatives of each Party and will meet (which
meetings may be in person, by videoconference or by teleconference)
periodically at such times as the members of the Coordination
Committee shall agree. Each Party will use Commercially Reasonable
and Diligent Efforts to keep the other Party infor