NON-EXCLUSIVE LICENSE AGREEMENT
Exhibit
2
[*]
indicates that a confidential portion of the text of this agreement has been
omitted.
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 Xxxxxxx Xxxxxxx Xxxxx, Xxxxxxx, Xxxxxx Xxxxx, Xxxxxxx, and
Pfizer Inc. (“PFIZER”), a Delaware corporation having offices located at
000 Xxxx 00xx Xxxxxx, Xxx Xxxx, XX 00000 XXX.
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:
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ARTICLE
1— DEFINITIONS
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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
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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
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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.
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ARTICLE
2— LICENSE
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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.
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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.
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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
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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 |
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 which the
applicable notice is given and the applicable payment is made, it is understood
that all of the other rights and obligations of the definitive agreement,
including, without limitation, those provided for in the definitive agreement
shall apply to such Acquired Immunoglobulin as if PFIZER had discovered,
isolated, characterized, optimized or developed, as applicable, such Acquired
Immunoglobulin.
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ARTICLE
3— CONSIDERATION
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3.1 Access
Fee. In consideration of access to the Patent Rights and for the right to
enjoy the license and other rights granted hereunder, PFIZER shall (a) pay
XOMA
by wire transfer a technology access fee of Thirty Million United States Dollars
(US$30,000,000) within fifteen (15) business days after the receipt by PFIZER
of
XOMA’s invoice and one fully executed copy of this Agreement and (b) pay XOMA an
additional upfront fee metered by Net Sales of Licensed Product(s) in accordance
with the provisions of Section 3.4.
3.2 Annual
Maintenance Fees. Commencing on the first (1st) anniversary of
the Effective Date, and for the term of this Agreement, PFIZER shall pay XOMA
an
annual maintenance fee, payable in cash or wire transfer within [*] days of
the
applicable anniversary, of [*], it being understood that,
notwithstanding the retroactive nature of the license granted in Section 2.1,
no
such fee shall be due with respect to periods prior to the Effective
Date.
3.3 Milestone
Payments. (a) With respect to each Licensed Product in
each indication, PFIZER shall make the following milestone payments upon
achievement of the corresponding milestone events, provided, however,
that (i) in accordance with the provisions below, each such milestone payment
shall be due only once for each such Licensed Product in each indication, and
(ii) notwithstanding the retroactive nature of the license granted in Section
2.1, no such milestone payments shall be due with respect to milestone events
achieved prior to the Effective Date:
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Event
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Payment
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[*]
(b) With
respect to each Licensed Product, PFIZER shall also make the following milestone
payments upon achievement of the corresponding milestone events, provided,
how
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ever,
that (i) in accordance with the provisions below, each such milestone payment
shall be due only once for each such Licensed Product, and (ii) notwithstanding
the retroactive nature of the license granted in Section 2.1, no such milestone
payments shall be due with respect to milestone events achieved prior to the
Effective Date:
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Event
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Payment
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[*]
3.4 Royalties. (a) PFIZER
shall pay to XOMA a royalty on Net Sales (as defined below) of each Licensed
Product of [*] percent ([*]%).
(b) No
more than one royalty payment shall be due under this Agreement with respect
to
a sale of a particular Licensed Product. No multiple royalties shall
be payable hereunder because any Licensed Product or its manufacture, sale
or
use is covered by more than one Valid Claim.
(c) [*].
(d) “Net
Sales” means [*].
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ARTICLE
4— PAYMENTS; REPORTS AND
RECORDS
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4.1 Currency. All
payments hereunder shall be computed and paid in United States dollars by wire
transfer to an account designated by XOMA. For the purpose of
determining the amount of royalty payments due for the relevant Pfizer Quarter,
the amount of Net Sales in any foreign currency shall be converted into U.S.
dollars in a manner consistent with the methodology used to prepare PFIZER’s
audited financial statements for external reporting purposes, provided that
such
practices uses a widely accepted source of published exchange
rates.
4.2 Reports
and Payments. PFIZER shall make a written report to XOMA within
[*] days of the achievement of each of the milestone events set forth in Section
3.3 with respect to each Licensed Product, stating in each such report the
Licensed Product to which such milestone event relates and the specific
milestone event achieved, including the relevant agency or other regulatory
body. After the first commercial sale of a Licensed Product on which
royalties are required to be paid hereunder, PFIZER shall make quarterly written
reports to XOMA within [*] days after the end of each Pfizer Quarter, stating
in
each such report, by country, the number, description, and aggregate Net Sales
of each Licensed Product sold during the calendar quarter. XOMA shall
treat all such reports as Confidential Information of
PFIZER. Concurrently with the making of such reports, PFIZER shall
pay XOMA the amounts specified in Sections 3.3 and 3.4 hereof.
4.3 Records;
Inspection. PFIZER shall keep complete, true and accurate books
of account and records for the purpose of determining the royalty amounts
payable under this Agreement. Such books and records shall be kept at
the principal place of business of PFIZER for at least [*] years following
the
end of the calendar quarter to which they pertain and will be available for
inspection during such period by a representative of XOMA for the
purpose
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of
verifying the royalty reports and payments. Such inspections shall be
made during ordinary business hours. The representative may be
obliged to execute a reasonable confidentiality agreement prior to commencing
any such inspection. Inspections conducted under this Section 4.3
shall be at the expense of XOMA, unless an underpayment exceeding [*] percent
([*]%) of the amount stated for the full period covered by the inspection is
identified, in which case all out-of-pocket costs relating to the inspection
will be paid immediately by PFIZER. Any underpayments or unpaid
amounts discovered by such inspections or otherwise will be paid immediately
by
PFIZER, [*].
4.4 Taxes. It
is understood and agreed between the Parties that any royalties or other
payments made under this Agreement are inclusive of any value-added or similar
tax imposed upon such payments. Any income or other taxes which
PFIZER is required to pay or withhold on behalf of XOMA with respect to
royalties and any other monies payable to XOMA under this Agreement, other
than
taxes imposed on or measured by net income, shall be deducted as required by
law
and treaty from the amount of such royalties and monies due. PFIZER
shall furnish XOMA with receipt of confirmation of payment from taxing
authorities evidencing timely payment of amounts withheld and shall cooperate
and, upon request, discuss with XOMA the basis for such
withholding. Any such tax required to be paid or withheld shall be an
expense of, and borne solely by, XOMA. PFIZER shall cooperate with
XOMA to claim exemption from such deductions or withholdings under any double
taxation or similar agreement in force from time to time. Upon
receipt from XOMA of a valid IRS Form W-8 BEN (claiming entitlement to exemption
from U.S. withholding tax under the U.S./Ireland income tax treaty), PFIZER
shall pay all royalties and other moneys due to XOMA free of U.S. withholding
tax, unless and until such IRS Form W-8 BEN becomes invalid as a result of
a
change in facts or applicable law. If PFIZER makes any payment
without reduction for withholding and it later transpires that an amount of
tax
should have been withheld on such royalty or other payment (“underwithheld
tax”), PFIZER shall be entitled to recover the underwithheld tax by an
additional withholding from any later payment due to XOMA under this
Agreement. PFIZER shall notify XOMA in writing regarding the reason
for any such additional withholding. Similarly, if PFIZER withholds
an amount of tax which is later determined to have not been due, PFIZER shall
reimburse XOMA for such overwithheld amounts plus applicable overpayment
interest it received from the government, if any. XOMA shall have the
right to inspect correspondence and records relating to such withholding tax
issues on the same terms as described in Section 4.3 above.
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ARTICLE
5— [*]
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ARTICLE
6— CONFIDENTIALITY
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6.1 Confidential
Information. Except as expressly provided herein, the Parties
agree that, for the term of this Agreement and for [*] years thereafter, the
receiving Party shall keep completely confidential and shall not publish or
otherwise disclose and shall not use for any purpose except for the purposes
contemplated by this Agreement any Confidential Information furnished to it
by
the disclosing Party hereto, except that to the extent that it can be
established by the receiving Party by written proof that such Confidential
Information:
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(a)
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was
already known to the receiving Party, other than under an obligation
of
confidentiality, at the time of
disclosure;
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(b)
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was
generally available to the public or otherwise part of the public
domain
at the time of its disclosure to the receiving
Party;
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(c)
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became
generally available to the public or otherwise part of the public
domain
after its disclosure and other than through any act or omission of
the
receiving Party in breach of this Agreement;
or
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(d)
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was
subsequently lawfully disclosed to the receiving Party by a person
other
than a Party hereto.
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6.2 Permitted
Use and Disclosure. Each Party hereto may use or disclose
information disclosed to it by the other Party to the extent such use or
disclosure is reasonably necessary in complying with applicable law or
governmental regulations or conducting preclinical or clinical trials or filing
or prosecuting patent applications, or obtaining Regulatory Approval;
provided that if a Party is required to make any such disclosure of
another Party’s Confidential Information, other than pursuant to a
confidentiality agreement, it will give reasonable advance notice to the latter
Party of such disclosure and will use its reasonable commercial efforts to
secure confidential treatment of such information prior to its disclosure
(whether through protective orders or otherwise).
6.3 Confidential
Terms. Except as expressly provided herein, each Party agrees not
to disclose any terms of this Agreement to any Third Party without the consent
of the other Party; provided, however, that disclosures may be
made as required by securities or other applicable laws, or to actual or
bona fide prospective corporate partners, acquirors or investors, or to
a Party’s accountants, attorneys and other professional advisors, in each case
who agree to be bound by the confidentiality provisions of this Agreement or
are
otherwise subject to requirements of confidentiality with respect to disclosure
thereof at least as stringent as those contained herein.
6.4 Agreement
Announcement. The Parties hereby agree to the release of a press
release in the form attached hereto as Schedule 6.4 upon full execution
of this Agreement, that the fact of the consummation of this Agreement as well
as such terms as are expressly described in such press release shall be deemed
to be in the public domain[*].
6.5 Filing,
Registration or Notification of this Agreement. If a Party
determines that it is required by law or a securities exchange to publicly
file,
register or notify this Agreement with a governmental authority, such Party
shall (i) initially file a copy of this Agreement excluding, at a minimum,
the
provisions redacted from the form of Agreement in Schedule 6.5 attached
hereto (the “Redacted Agreement”), (ii) request, and use commercially
reasonable efforts to obtain, confidential treatment of all terms redacted
from
this Agreement as reflected in the Redacted Agreement for a period of at least
[*] years, (iii) submit to the other Party such request for confidential
treatment and any subsequent correspondence with respect thereto at least five
(5) Business Days prior to its submission to such governmental authority, (iv)
[*], and (vi) if
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such
governmental authority requests any changes to the redactions set forth in
the
Redacted Agreement, use commercially reasonable efforts to support the
redactions in the Redacted Agreement as originally filed and shall not agree
to
any changes to the Redacted Agreement without first discussing such changes
with
the other Party and taking the other Party’s comments into consideration when
deciding whether to agree to such changes. [*]
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ARTICLE
7— REPRESENTATIONS AND
WARRANTIES
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7.1 Representations
and Warranties of XOMA. As of the Effective Date, XOMA represents
and warrants that it has the right to grant the licenses provided for
herein.
7.2 Representations
and Warranties of PFIZER. As of the Effective Date, PFIZER
represents and warrants that, to its knowledge, none of its currently marketed
products or products under review by the Food and Drug Administration for
marketing approval were discovered, isolated, optimized, made or used
under conditions that constituted infringement of the XOMA Patent
Rights.
7.3 Representations
and Warranties of Both Parties. Each Party hereby represents and
warrants to the other Party as follows:
(a) Existence. Such
Party is duly organized, validly existing and in good standing under the laws
of
the jurisdiction in which it is organized.
(b) Authorization
and Enforcement of Obligations. Such Party has the full right,
power and authority to enter into this Agreement and has taken all necessary
corporate action on its part to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party
in accordance with its terms.
(c) Consents. All
necessary consents, approvals and authorizations of all governmental authorities
and other entities required to be obtained by such Party in connection with
this
Agreement have been obtained.
7.4 Disclaimer. Nothing
in this Agreement is or shall be construed as:
(a) a
warranty or representation as to the validity or scope of any claim or patent
within the Patent Rights;
(b) a
warranty or representation that anything made, used, sold, or otherwise disposed
of under any license granted in this Agreement is or will be free from
infringement of any patent rights or other intellectual property right of any
Third Party;
(c) an
obligation to bring or prosecute actions or suits against Third Parties for
infringement of any of the Patent Rights; or
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(d) granting
by implication, estoppel, or otherwise (except as expressly set forth herein)
any licenses or rights under patents or other rights of XOMA or Third Parties
unrelated to the subject matter of the license granted in this
Agreement.
7.5 No
Warranties. EXCEPT AS PROVIDED IN SECTIONS 7.1, 7.2 AND 7.3
ABOVE, NEITHER PFIZER NOR XOMA GRANTS TO THE OTHER PARTY ANY WARRANTIES OR
REPRESENTATIONS. XOMA GRANTS NO WARRANTIES WITH RESPECT TO THE
LICENSED TECHNOLOGY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF
LAW,
BY STATUTE OR OTHERWISE. XOMA SPECIFICALLY DISCLAIMS ANY EXPRESS OR
IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY
OF THE PATENT RIGHTS OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS
OF
ANY THIRD PARTY.
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ARTICLE
8— INDEMNIFICATION
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8.1 PFIZER
agrees to indemnify, defend and hold XOMA and its directors, officers, employees
and agents (collectively with XOMA, the “XOMA Indemnitees”) harmless from
and against any and all liabilities, claims, losses, demands, expenses
(including, without limitation, attorneys and professional fees and other costs
of litigation), losses or causes of action (each, a “Liability” and
collectively, “Liabilities”) arising out of or relating in any way to a
lawsuit by a Third Party relating to (a) the possession, manufacture, use,
sale
or other disposition of Licensed Products and/or PFIZER Display Systems, whether
based on breach of warranty, negligence, product liability or otherwise, (b)
the
exercise of any right granted to PFIZER pursuant to this Agreement, or (c)
any
breach of this Agreement by PFIZER, except and solely to the extent, in each
case, that such Liability is caused by the gross negligence or willful
misconduct of XOMA.
8.2 XOMA
agrees to indemnify, defend and hold PFIZER and its directors, officers,
employees and agents (collectively with PFIZER, the “PFIZER Indemnitees”)
harmless from and against any and all Liabilities arising out of or relating
in
any way to a lawsuit by a Third Party relating to a breach by XOMA of its
representations and warranties hereunder, except and solely to the extent that
such Liability is caused by the gross negligence or willful misconduct of
PFIZER.
8.3 Procedure. A
PFIZER Indemnitee and a XOMA Indemnitee shall be each separately referred to
herein as an “Indemnitee.” PFIZER and XOMA, when acting to
indemnify an Indemnitee, shall be each separately referred to herein as the
“Indemnitor.” An Indemnitee that intends to claim
indemnification under this Article 8 shall promptly notify the Indemnitor of
any
claim, demand, action or other proceeding for which the Indemnitee intends
to
claim such indemnification. The Indemnitor shall have the right to
participate in, and to the extent the Indemnitor so desires to assume, the
defense thereof with counsel selected by the Indemnitor; provided,
however, that the Indemnitee shall have the right to retain its
own
counsel, with the fees and expenses to be paid by the Indemnitee. The
indemnity obligations under this Article 8 shall not apply to amounts paid
in
settlement of any claim, demand, action or other proceeding if such settlement
is effected without the prior express written consent of the Indemnitor, which
consent
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shall
not
be unreasonably withheld or delayed. The failure to deliver notice to
the Indemnitor within a reasonable time after notice of any such claim or
demand, or the commencement of any such action or other proceeding, if
materially prejudicial to its ability to defend such claim, demand, action
or
other proceeding, shall relieve such Indemnitor of any liability to the
Indemnitee under this Article 8 with respect thereto, but the omission so to
deliver notice to the Indemnitor shall not relieve it of any liability that
it
may have to the Indemnitee otherwise than under this Article 8. The
Indemnitor may not settle or otherwise consent to an adverse judgment in any
such claim, demand, action or other proceeding, that diminishes the rights
or
interests of the Indemnitee without the prior express written consent of the
Indemnitee, which consent shall not be unreasonably withheld or
delayed. The Indemnitee, its employees and agents, shall reasonably
cooperate with the Indemnitor and its legal representatives in the investigation
of any claim, demand, action or other proceeding covered by this Article
8.
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ARTICLE
9— TERM AND TERMINATION
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9.1 Term. The
term of this Agreement commenced on the Effective Date and will remain in full
force and effect until [*].
9.2 Termination
for Cause. Either Party may terminate this Agreement in the event
the other Party has materially breached or defaulted in the performance of
any
of its obligations hereunder, and such breach or default has continued for
[*]
days after written notice thereof was provided to the breaching Party by the
nonbreaching Party. Any termination shall become effective at the end
of such [*] day period unless the breaching Party has cured any such breach
or
default prior to the expiration of such period. Notwithstanding the
above, in the case of a failure to pay any amount due hereunder the period
for
cure of any such default following notice thereof shall be [*] days and, unless
payment is made within such period, the termination shall become effective
at
the end of such period.
9.3 Termination
for Insolvency. If voluntary or involuntary proceedings by or
against a Party are instituted in bankruptcy under any insolvency law, or a
receiver or custodian is appointed for such Party, or proceedings are instituted
by or against such Party for corporate reorganization or the dissolution of
such
Party, which proceedings, if involuntary, shall not have been dismissed within
[*] days after the date of filing, or if such Party makes an assignment for
the
benefit of creditors, or substantially all of the assets of such Party are
seized or attached and not released within [*] days thereafter, the other Party
may elect to immediately terminate this Agreement effective upon notice of
such
termination. However, insolvency does not automatically terminate
this Agreement.
9.4 Effect
of Termination.
(a) Accrued
Rights and Obligations. Termination of this Agreement for any
reason shall not release any Party hereto from any liability which, at the
time
of such termination, has already accrued to the other Party or which is
attributable to a period prior to such termination nor preclude either Party
from pursuing any rights and remedies it may have hereunder or at law or in
equity with respect to any breach of this Agreement. It is understood
and agreed that monetary damages may not be a sufficient remedy for any breach
of this Agreement and that
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the
non-breaching Party may be entitled to injunctive relief as a remedy for any
such breach. Such remedy shall not be deemed to be the exclusive
remedy for any such breach of this Agreement, but shall be in addition to all
other remedies available at law or in equity.
(b) Return
of Confidential Information. Upon any termination of this
Agreement, PFIZER and XOMA shall promptly return to the other Party all
Confidential Information received from the other Party (except XOMA may retain
copies of any reports or records referred to in Articles 4 or 5).
(c) Licenses. All
licenses granted hereunder shall terminate upon the termination of this
Agreement.
9.5 Survival. Sections
2.5, 4.3, 9.4 and 9.5, and Articles 1, 6, 7, 8 and 10 of this Agreement shall
survive the expiration or termination of this Agreement for any
reason.
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ARTICLE
10— MISCELLANEOUS
PROVISIONS
|
10.1 Governing
Laws; Venue. This Agreement and any dispute, including without
limitation any voluntary arbitration arising from the performance or breach
hereof shall be governed by and construed and enforced in accordance with the
laws of the state of New York, without reference to conflicts of laws
principles. The exclusive venue of any dispute arising out of or in
connection with the performance or breach of this Agreement shall be the New
York state courts or U.S. district court located in New York, and the Parties
hereby consent to the personal jurisdiction of such courts and waive any
objection that any such court would be an inconvenient forum.
10.2 Assignment. Neither
Party may transfer or assign this Agreement, or any rights hereunder without
the
prior written consent of the other Party; provided, that for purposes
of this Agreement, a Change in Control shall not be deemed to be a transfer
or
assignment; provided, further, that XOMA may assign this Agreement or
its rights hereunder, in whole or in part, to any Affiliate of
XOMA. Any attempted transfer or assignment in violation of this
Section 10.2 shall be void. For the avoidance of doubt, a Change of
Control of PFIZER or XOMA, in and of itself, shall not result in a termination
of this Agreement. This Agreement shall be binding upon and inure to
the benefit of the Parties and their permitted successors and
assigns.
10.3 Waiver. No
waiver of any rights shall be effective unless consented to in writing by the
Party to be charged and the waiver of any breach or default shall not constitute
a waiver of any other right hereunder or any subsequent breach or
default.
10.4 Severability. In
the event that any provisions of this Agreement are determined to be invalid
or
unenforceable by a court of competent jurisdiction, the remainder of the
Agreement shall remain in full force and effect without said
provision.
10.5 Notices. All
notices, requests and other communications hereunder shall be in writing and
shall be personally delivered or sent by telecopy or other electronic facsimile
transmission or by registered or certified mail, and shall be effective upon
receipt at the respect-
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tive
address specified below, or such other address as may be specified in writing
to
the other Party:
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PFIZER:
|
Pfizer
Inc.
00
Xxxxxx Xxxxxx
Xxx
Xxxxxx, Xxxxxxxxxxx
XXX
Attn:
Vice President, Strategic Allinces
|
|
With
a copy (which shall not constitute notice) to:
|
Pfizer
Inc.
00
Xxxxxx Xxxxxx
Xxx
Xxxxxx, Xxxxxxxxxxx
XXX
Attn:
Senior Vice President and Associate General Counsel
|
|
With
a copy (which shall not constitute notice) to:
|
Pfizer
Inc.
000
Xxxx 00xx Xxxxxx
Xxx
Xxxx, XX 00000
XXX
Attn: Senior
Vice President and General Counsel
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|
XOMA:
|
XOMA
Ireland Limited
Xxxxxxx
Xxxxxxx Xxxxx
Xxxxxxx,
Xxxxxx Xxxxx
Xxxxxxx
Attn: Company
Secretary
|
|
With
a copy (which shall not constitute notice) to:
|
Xxxxxx
Xxxxxx & Xxxxxxx LLP
00
Xxxx Xxxxxx
Xxx
Xxxx, XX 00000
XXX
Attn: Xxxxxxxx
X. Xxxxxxxx
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10.6 Independent
Contractors. Both Parties are independent contractors under this
Agreement. Nothing contained in this Agreement is intended nor is to
be construed so as to constitute XOMA or PFIZER as partners or joint venturers
with respect to this Agreement. Neither Party shall have any express
or implied right or authority to assume or create any obligations on behalf
of
or in the name of the other Party or to bind the other Party to any other
contract, agreement, or undertaking with any Third Party.
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10.7 Compliance
with Laws. In exercising their rights under this license, the
Parties shall fully comply in all material respects with the requirements of
any
and all applicable laws, regulations, rules and orders of any governmental
body
having jurisdiction over the exercise of rights under this
Agreement. PFIZER shall be responsible, at its expense, for making
any required registrations or filings with respect to this Agreement and
obtaining any necessary governmental approvals with respect hereto.
10.8 Use
of
Name. Neither Party shall use the name or trademarks of the other
Party without the prior written consent of such other Party.
10.9 Further
Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and do such other acts, as may be necessary and
appropriate in order to carry out the purposes and intent of this
Agreement.
10.10 Bankruptcy
Protection. All rights and licenses granted under or pursuant to
this Agreement by either Party are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code and other similar foreign
laws, licenses of rights to “intellectual property” as defined under Section 101
of the U.S. Bankruptcy Code or such foreign laws. Each Party agrees
that the other Party, as a licensee of such rights under this Agreement, shall
retain and may fully exercise all of its rights and elections under Section
365(n) of the U.S. Bankruptcy Code and other similar foreign laws, and neither
Party shall claim that this Agreement does not fall within the scope
thereof. Each Party further agrees that, upon the commencement of a
bankruptcy proceeding by or against such Party under the U.S. Bankruptcy Code,
the other Party shall be immediately entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property, and the same, if not already in
such
other Party’s possession, shall be promptly delivered to the other Party if such
Party rejects this Agreement, fails to promptly elect in writing to continue
to
perform all of its obligations under this Agreement, and/or fails to take all
steps necessary to protect such intellectual property.
10.11 Entire
Agreement; Amendment. This Agreement constitutes the entire and
exclusive agreement between the Parties with respect to the subject matter
hereof and supersedes and cancels all previous discussions, agreements,
commitments and writings in respect thereof. No amendment or addition
to this Agreement shall be effective unless reduced to writing and executed
by
the authorized representatives of the Parties.
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IN
WITNESS WHEREOF, XOMA and PFIZER have executed this Agreement by duly authorized
officers.
|
PFIZER
INC.
By: _____________________________
Xxxx
XxXxxxxxx
President,
Pfizer Global Research & Development
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XOMA
IRELAND LIMITED
By: ______________________________
Xxxx
Xxxx, Director
duly
authorized on behalf of
XOMA
Ireland
Limited in
the
presence
of the following
witness:
______________________________
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Schedule
1.22
Patent
Rights
[*]
