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Exhibit 2
[*] indicates that a confidential portion of the text of this
agreement has been omitted.
NON-EXCLUSIVE LICENSE AGREEMENT
This
Non-Exclusive License Agreement (the “ Agreement
”), effective, except as indicated, as of August 27,
2007 (the “ Effective Date ”), is entered
into by and between XOMA Ireland Limited (“ XOMA
”), an Irish company having offices located at Shannon
Airport House, Shannon, County Clare, Ireland, and Pfizer Inc.
(“ PFIZER ”), a Delaware corporation having
offices located at 235 East 42nd Street, New York, NY
10017 USA.
BACKGROUND
A. XOMA
is the owner or exclusive licensee of certain Patent Rights
(as defined below), and PFIZER wishes to acquire a
non-exclusive license under the Patent Rights;
and
B. XOMA
is willing to grant PFIZER such a non-exclusive license, on
the terms and conditions set forth below.
NOW,
THEREFORE, in consideration of the promises and the mutual
covenants hereinafter recited, the parties agree as
follows:
In
this Agreement, the following terms shall have the following
meanings:
1.1
“
Acquired Immunoglobulins ” has the meaning set forth
in Section 2.8(b).
1.2
“
Acquisition Entity ” has the meaning set forth in
Section 2.8(a).
1.3
“
Acquisition Fee ” has the meaning set forth in Section
2.8(d).
1.4
“
Affiliate ” means any corporation or other entity
which is directly or indirectly controlling, controlled by or under
common control with a Party hereto. For the purpose of
this Agreement, “control” shall mean the direct or
indirect possession of at least a majority of the voting interest
of the subject entity (whether through ownership of securities, by
contract or otherwise).
1.5
“
BLA ” means a Biologics License Application (or, if
applicable, a Product License Application), as defined in the U.S.
Food, Drug and Cosmetic Act and the regulations promulgated
thereunder, and any corresponding U.S. or foreign application,
registration or certification.
1.6
“
Change in Control ” means, with respect to a
particular Party [*].
1.7
“
Combination Product ” has the meaning set forth in
Section 3.4(d).
1.8
“
Confidential Information ” means (a) any proprietary
or confidential information or material in tangible form disclosed
hereunder that is designated as “Confidential”
at
the
time it is delivered to the receiving Party, or (b)
proprietary or confidential information disclosed orally
hereunder which is identified as confidential or proprietary
when disclosed and such disclosure of confidential information
[*].
1.9
“
Display System ” means a system for the use of Display
Materials.
1.10
“
Display Materials ” means (a) any collection or
library of polynucleotide sequences which encodes at least one
polypeptide and which is contained in a display system which can be
propagated in bacteria including, without limitation, filamentous
bacteriophage and/or bacteriophage or phagemid cloning vectors, or
(b) any collection or library of bacteriophage wherein a
polypeptide is expressed as a fusion protein comprising the
polypeptide and an outer surface polypeptide of a carrier which can
be expressed or propagated in bacteria. For the
avoidance of doubt, Display Materials shall include any such
materials wherein the polypeptide is an
Immunoglobulin.
1.11
“
Dispose ” has the meaning set forth in Section
2.7.
1.12
“
Field ” means the treatment, diagnosis or prophylaxis
of any disease or conditions in a human or animal.
1.13
“
Immunoglobulin ” means any molecule that has an amino
acid sequence by virtue of which it specifically interacts with an
antigen and wherein any portion of the molecule contain a
functionally operating region of an antibody variable region
including, without limitation, any naturally occurring or
recombinant form of such a molecule. Included within the
definition of an Immunoglobulin, but without limiting the
definition thereof shall be full length antibodies, fragments
thereof, molecules containing heavy chains only or antibodies
derived from the foregoing (such as diabodies).
1.14
“
IND ” means an Investigational New Drug application,
as defined in the U.S. Food, Drug and Cosmetic Act and the
regulations promulgated thereunder for initiating clinical trials
in the United States, or any corresponding foreign application,
registration or certification.
1.15
“
Indemnitee ” has the meaning set forth in Section
8.3.
1.16
“
Indemnitor ” has the meaning set forth in Section
8.3.
1.17
“
Liability ” and “ Liabilities ”
have the respective meanings set forth in Section 8.1.
1.18
“
Licensed Product ” means any composition of matter or
article of manufacture which (a) arises out of the practice by
PFIZER of a Valid Claim of the Patent Rights, or (b) is made or
sold under conditions which, if unlicensed, would constitute
infringement of a Valid Claim, provided, however
, that the term “Licensed Product” shall not include
Display Materials or any composition of matter or article of
manufacture which (i) is discovered, isolated, characterized,
optimized, altered or produced by the use of a Display System other
than a
PFIZER
Display System or (ii) was discovered, isolated,
characterized, optimized or altered by a Third
Party.
1.19
“
NDA ” means a New Drug Application, as defined in the
U.S. Food, Drug and Cosmetic Act and the regulations promulgated
thereunder, or any corresponding U.S. or foreign application,
registration or certification.
1.20
“
Net Sales ” has the meaning set forth in Section
3.4(d).
1.21
“
Party ” means either XOMA or PFIZER.
1.22
“
Patent Rights ” means the patent applications and
patents listed on Schedule 1.22 hereto and all divisionals,
continuations, continuations-in-part, and substitutions thereof;
all foreign patent applications corresponding to the preceding
applications or directly or indirectly claiming priority to or from
any of the foregoing; and all U.S. and foreign patents issuing on
any of the preceding applications, including extensions, reissues,
and reexaminations.
1.23
“
Pfizer Discount or Savings Program ” has the meaning
set forth in Section 3.4(d).
1.24
“
PFIZER Display System ” means (a) any Display System
created by PFIZER in accordance with this agreement after the
Effective Date; (b) any Display System created by a Third Party
pursuant to a valid and effective license under the Patent Rights
permitting the creation, use and transfer of such Display System
and/or (c) those Display Systems currently in the possession of
PFIZER. No Display System shall be deemed to be a PFIZER
Display System unless: (a) PFIZER’s control, use and
possession of such PFIZER Display System is permitted by (i) the
applicable Third Party license from XOMA referred to in clause (b)
above, or (ii) this Agreement, and (b) such PFIZER Display System
is used exclusively by PFIZER or its Affiliates. For the avoidance
of doubt, the applicable terms of any license covering a PFIZER
Display System referred to in clause (b) of this Section 1.24 shall
also apply to PFIZER’s activities hereunder.
1.25
“
PFIZER Indemnitees ” has the meaning set forth in
Section 8.2.
1.26
“
Pfizer Quarter ” means each fiscal period comprised of
the four (4) thirteen (13) week periods (i) with respect to the
United States, commencing on January 1 of any year, and (ii) with
respect to any country other than the United States, commencing on
December 1 of any year.
1.27
“
Phase III ” means human clinical trials, the
principal purpose of which is to establish safety and efficacy in
patients as required by the applicable regulations or standards of
the Food and Drug Administration, or similar clinical study in a
country other than the United States. Phase III
shall also include any other human clinical trial intended as a
pivotal trial for Regulatory Approval.
1.28
“
Preexisting License ” means, with respect to the
acquisition by PFIZER of a particular Acquisition Entity or a
Change of Control of PFIZER involving a particular
Third
Party,
a license under the Patent Rights (or a subset thereof)
separate and apart from this Agreement obtained by such
Acquisition Entity or Third Party prior to the time of such
acquisition or Change of Control, as applicable.
1.29
“
Regulatory Approval ” means approval by the FDA of any
application seeking authorization to market, sell or promote any
Licensed Product or, in any country other than the United States,
approval by regulatory authorities having jurisdiction over
approval in such country of a single application or set of
applications seeking authorization to market, sell or promote any
Licensed Product in such a country. The term
“Regulatory Approval” shall, without limiting the
definition set forth herein, include the approval of any BLA or New
Drug Application or any foreign equivalent thereto.
1.30
“
Research and Development ” means the identification,
selection, isolation, purification, characterization, optimization,
improvement, alteration, study and/or testing of an
Immunoglobulin. Included within the term “Research
and Development” shall be all in vitro screening or
assays customarily performed in pre-clinical and clinical research
and uses associated with obtaining FDA or equivalent agency
regulatory approval. The term “Research and
Development” shall not include commercial
manufacture. For the avoidance of doubt, the term
“Research and Development” shall not include activities
undertaken on behalf of any Third Party, whether in a collaboration
or as a fee for service business.
1.31
“
Selling Parties ” has the meaning set forth in Section
3.4(d).
1.32
“
Third Party ” means any person or entity other than
PFIZER and its subsidiaries or XOMA and its
Affiliates.
1.33
“
Third Party Agreement ” has the meaning set forth in
Section 2.2.
1.34
“
underwithheld tax ” has the meaning set forth in
Section 4.4.
1.35
“
Valid Claim ” means (a) a claim of an issued and
unexpired patent included within the Patent Rights which claim has
not been held invalid in a final decision of a court of competent
jurisdiction from which no appeal may be taken, and which has not
been disclaimed or admitted to be invalid or unenforceable through
reissue or otherwise, [*].
1.36
“
XOMA Indemnitees ” has the meaning set forth in
Section 8.1.
2.1
Grant to PFIZER . Subject to the terms and
conditions of this Agreement, XOMA hereby grants to PFIZER a
non-exclusive, non-transferable, worldwide license, solely within
the Field, under the Patent Rights, without the right to grant
sublicenses, on its own behalf to conduct Research and Development
and to make, have made, use, sell, have sold, offer to sell, import
and export Licensed Products, including without limitation Licensed
Products arising out of a PFIZER Display System. The
license granted pursuant to this Section 2.1 shall be [*]
retroactive.
2.2
Licenses to Certain Third Parties . On a Licensed
Product-by-Licensed Product basis, if PFIZER transfers, assigns or
licenses all or substantially all of its own rights to any Licensed
Product that is properly subject to this Agreement to a Third Party
(other than a Third Party to which Section 2.3 applies), XOMA
shall, solely as to each such Licensed Product, grant a direct
license to such Third Party to make, have made, use, sell, have
sold, offer to sell, import and export such Licensed Product on the
same terms and conditions as those provided herein. [*]
In addition, in the event any such Third Party is already subject
to an agreement with XOMA with respect to the development,
commercialization or manufacture of products that would include
such Licensed Product (a “ Third Party Agreement
”), the applicable royalty, milestone and royalty term
provisions of that Third Party Agreement shall apply, but such
Licensed Product shall otherwise be subject to the non-financial
terms (including without limitation the definition of Net Sales and
the reporting and payment provisions) of this
Agreement.
2.3
Licenses to Affiliates and Certain Third Parties
. (a) The license granted pursuant to Section 2.1 shall
extend to and include (i) for PFIZER’s benefit, each
Affiliate of PFIZER as of the Effective Date; (ii) for
PFIZER’s benefit, each Affiliate of PFIZER that PFIZER
specifies at any time and from time to time after the Effective
Date; and (iii) any Third Party who, as a bona fide part
of the PFIZER global supply and distribution chain, solely on
PFIZER’s behalf, makes, has made, uses, sells, offers to
sell, imports or exports a Licensed Product. Any license
extended to an Affiliate or Third Party pursuant to this Section
2.3(a) shall be personal to such Affiliate or Third Party, shall be
on the same terms and conditions as those provided herein and
shall, except as to Licensed Products discovered, developed, made,
sold, offered for sale, imported or exported solely for PFIZER or
its Affiliates, terminate upon a Change of Control of PFIZER or the
applicable Affiliate.
(b) In
order to facilitate payments from countries other than the
United States, XOMA shall, whenever requested by PFIZER and
where commercially reasonable to XOMA, enter into direct
agreements with an Affiliate designated by PFIZER whereby said
Affiliate will be obligated to remit any payments due for
sales in such country directly to XOMA and XOMA shall execute
such formal direct agreement documents as PFIZER may request
which may be necessary to effect such
purposes. Such formal direct agreement documents
shall provide for the same terms as this Agreement insofar as
such terms are lawful under the applicable laws and
regulations of the particular country. However,
PFIZER shall remain primarily liable for and guarantee all
payments due XOMA.
2.4
No Implied Rights . Only the rights and licenses
granted pursuant to the express terms of this Agreement shall be of
any legal force or effect.
2.5
Ownership, Enforcement . At all times XOMA will
retain ownership of the Patent Rights and may use and commercialize
the Patent Rights itself or with any Third Party for any purpose
whatsoever. XOMA retains the right, at its sole
discretion, to enforce, maintain and otherwise protect the Patent
Rights. PFIZER, at XOMA’s expense, shall
reasonably cooperate with XOMA’s reasonable written requests
to PFIZER with respect to any actions XOMA may choose to take
related to the enforcement, maintenance or protection of the Patent
Rights.
2.6
PFIZER Site Activities . Any Research and
Development activities undertaken pursuant to this Agreement
involving the practice of the Patent Rights or use of materials
provided by XOMA or any PFIZER Display System shall be conducted
only by PFIZER employees at facilities owned or exclusively
controlled by PFIZER. For the avoidance of
doubt, PFIZER may, consistent with this Agreement or any
applicable license granted by XOMA, transfer and use, but not sell
or lease, any PFIZER Display System to the facilities specified
pursuant to this Section 2.6, provided , however
, that any activities undertaken at a facility outside of the
United States must occur under conditions which comply with all
applicable export rules and regulations.
2.7
[*]
2.8
PFIZER After-Acquired Products and Entities . (a) In
the event PFIZER creates or acquires an entity that thereupon
becomes an Affiliate or acquires or controls an operating unit or
assets of another entity (such new entity, the “
Acquisition Entity ”), such Acquisition Entity shall,
subject to the foregoing, be deemed to be a part of PFIZER and
enjoy all of the rights and licenses otherwise enjoyed by PFIZER
from the time it becomes an Acquisition Entity; provided,
however, that if such Acquisition Entity derives substantial
revenue from conducting commercial antibody evolution or commercial
antibody discovery for hire for Third Parties, the activities
constituting such conduct for hire shall not be covered by any of
the licenses or other rights granted by this Agreement, except to
the extent such activities are licensed under a Preexisting License
as provided in Section 2.8(c); provided, further, however
, that the foregoing provision regarding commercial antibody
evolution or commercial antibody discovery businesses shall not be
deemed to deprive PFIZER of any rights to any specific
Immunoglobulin otherwise subject to Section
2.8(b). [*].
(b) Subject
to Section 2.8(c), in the event that PFIZER, after the
Effective Date, obtains by creation or acquisition of an
Acquisition Entity control of one or more Immunoglobulins
discovered, developed, made, used, sold, offered for sale or
imported under conditions which utilized or involved the
practice of the Patent Rights (“ Acquired
Immunoglobulins ”), then each such Acquired
Immunoglobulin shall be treated, as of the date of the payment
of the applicable fee described in Section 2.8(d), as if it
were a Licensed Product under this Agreement (i) immediately
if the Acquisition Entity was licensed under the Patent
Rights, or (ii) upon the satisfaction of the other
requirements set forth herein.
(c) Notwithstanding
Section 2.8(b), if the Acquisition Entity has, prior to the
time of the acquisition, obtained a Preexisting License, then
the terms of this Agreement, other than the applicable royalty
rate, milestones and royalty terms, supersede the terms of the
Preexisting License where such terms are in
conflict. All other terms of the Preexisting
License remain in full force and effect.
(d) In
order for PFIZER to obtain the benefit of this Agreement with
respect to Section 2.8(b) or Section 2.8(c), PFIZER must,
within [*] days of the date of obtaining such control of such
Acquired Immunoglobulin(s), provide written notice to XOMA
specifying the identity of the Acquisition Entity and Acquired
Immunoglobulin(s) and the current stage of development of the
most advanced of such Acquired
Immunoglobulin(s). Simultaneously with
the
delivery
of such written notice, depending upon the stage of
development at closing of the most advanced of such Acquired
Immunoglobulin(s), PFIZER shall pay, for each set of Acquired
Immunoglobulins (an “ Acquisition Fee ”)
set forth in the following table:
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Stage of Development of the Most Developed
Acquired Immunoglobulin at Closing
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Acquisition Fee
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[*]
(e) Upon
receipt of the applicable fee, XOMA shall acknowledge in
writing receipt of such payment and that the identified
Acquired Immunoglobulin(s) shall, as of that date, be treated
as Licensed Product(s) for all purposes under this
Agreement. For each Acquired Immunoglobulin as to
wh
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