Exhibit 2
[*] indicates that a confidential portion of the text of this agreement has been
omitted.
Execution Copy
LICENSE AGREEMENT
This License Agreement (this "Agreement"), effective as of December 29,
2003 (the "Effective Date"), is entered into by and between XOMA Ireland
Limited, a company with limited liability organized under the laws of the
Republic of Ireland having offices at Xxxxxxx Xxxxxxx Xxxxx, Xxxxxxx, Xxxxxx
Xxxxx, Xxxxxxx (with its Affiliates "XOMA"), and Diversa Corporation, a Delaware
corporation, with offices at 0000 Xxxxxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx,
00000-0000 (with its Affiliates, "DIVERSA").
BACKGROUND
A. XOMA is the owner or exclusive licensee of certain patent rights and
know-how relating to bacterial cell expression, and DIVERSA wishes to acquire
non-exclusive licenses under such patent rights and know-how; and
B. XOMA is willing to grant DIVERSA non-exclusive licenses, on the terms
and conditions set forth below, in order to permit DIVERSA to engage in certain
research, development and commercial activities; and
C. DIVERSA has a business based on the discovery, evolution, development
and commercialization of novel biomolecules for chemical, industrial,
agricultural and pharmaceutical applications.
NOW, THEREFORE, in consideration of the promises and the mutual covenants
hereinafter recited, the parties agree as follows:
ARTICLE 1
DEFINITIONS
In this Agreement, the following terms shall have the meanings set forth in
this Article.
1.1 "Affiliate" means any company, corporation or other entity which is
directly or indirectly controlling, controlled by or under common control with a
party hereto. For purposes of this Agreement, with respect to any company,
corporation or other entity, "control" (including, with correlative meanings,
the terms "controlled" and "controlling") means the possession, directly or
indirectly, of the power to direct or cause the direction of the management or
policies of the subject company, corporation or other entity, whether through
the ownership of voting securities, by agreement or otherwise.
1.2 "Antibody Evolution" means the alteration of the nucleic acids encoding
an Immunoglobulin by [*] as described in the DIVERSA Patent Rights, by means
other than Antibody Phage Display.
1.3 "Antibody Phage Display" means the use of antibody phage display
materials or the conduct of antibody phage display, including without limitation
to conduct Research and Development.
1.4 "Change in Control" means, with respect to Diversa Corporation or XOMA
Ltd., any transaction or series of transactions as a result of which any person
or group (as defined under Section 13(d) or 14(d) of the U.S. Securities
Exchange Act of 1934, as amended (the "Exchange Act")) , excluding any employee
benefit plan, or related trust, sponsored or maintained by such entity or any
entity controlled by such entity becomes, directly or indirectly, the beneficial
owner (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of
more than fifty percent (50%) of the total voting power of such entity's equity
securities.
1.5 "Commercial Antibody Evolution Business" means, with respect to protein
or other evolution services, libraries, products or materials, the
out-licensing, commercial manufacture, sale, offer for sale, import for sale or
export for sale of such protein or other evolution services, libraries, products
and materials.
1.6 "Commercial Antibody Phage Display Business" means, with respect to
immunoglobulin or antibody phage display services, libraries, products or
materials, the out-licensing, commercial manufacture, sale, offer for sale,
import for sale or export for sale of such immunoglobulin or antibody phage
display services, libraries, products and materials.
1.7 "Confidential Information" means any proprietary or confidential
information or material disclosed by a party to the other party pursuant to this
Agreement, which is (i) disclosed in tangible form hereunder and is designated
thereon as "Confidential" at the time it is delivered to the receiving party, or
(ii) disclosed orally hereunder and identified as confidential or proprietary
when disclosed and such disclosure of confidential information is confirmed in
writing within thirty (30) days by the disclosing party.
1.8 "Development Partner" means a Third Party from whom a party either
in-licenses a target for development and/or commercialization or with whom a
party shares the economic risk of development or commercialization of a target
or product being developed or commercialized on behalf of the applicable party.
1.9 "DIVERSA Collaborator" means any person or entity on whose behalf
DIVERSA engages in Antibody Evolution and/or a person or entity who is the
intended recipient of Licensed Immunoglobulins or Licensed Immunoglobulin
Information transferred from DIVERSA; provided, however, that such person or
entity shall not be deemed to be a DIVERSA Collaborator unless and until the
requirements of Section 2.5 are complied with. Except as expressly set forth on
Schedule 2.8(i) and Schedule 2.8(ii), no person or entity shall be deemed to be
a DIVERSA Collaborator if such person or entity is engaged in a Commercial
Antibody Phage Display Business or a Commercial Antibody Evolution Business
unless, pursuant to a written agreement (other than this Agreement), executed
after the Effective Date, XOMA has granted to such person or entity a valid
license or covenant not to xxx under the XOMA Patent Rights which explicitly
extends to the activities identified in this second sentence of Section 1.9.
XOMA shall provide DIVERSA prompt written notice of those written agreements or
covenants not to xxx which satisfy the requirements of the prior sentence. No
person or entity may claim
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the status of DIVERSA Collaborator with respect to any acts or activities which
are unrelated to the conduct of Antibody Evolution.
1.10 "DIVERSA Direct Costs" means those FTE costs incurred by DIVERSA in
the performance of those activities undertaken pursuant to a DIVERSA Action Plan
(as defined in Section 4.3). In determining "DIVERSA Direct Costs" chargeable
under this Agreement pursuant to each DIVERSA Action Plan, DIVERSA shall use its
established project accounting system . A DIVERSA "Full Time Equivalent" or
"FTE" shall mean the equivalent of one full year of work on a full time basis by
a scientist or other professional (whether an employee or independent contractor
of DIVERSA) possessing skills and experience necessary to carry out the research
activities by DIVERSA contemplated by this Agreement, determined in accordance
with DIVERSA's normal policies and procedures. The FTE rate shall be [*] United
States Dollars (US$[*]). Specifically excluded from the definition of DIVERSA
Direct Costs are any amounts partially allocable to other projects or activities
(internal or otherwise) other than a XOMA Project (as defined in Section 4.3).
1.11 "DIVERSA Evolution Technologies" means the inventions patentable under
applicable patent law that are claimed in the DIVERSA Patent Rights which both
(a) are owned or controlled by DIVERSA and (b) either (i) comprise evolution of
a gene and/or gene pathway by [*], or (ii) comprise evolution of a gene and/or
gene pathway by [*] described in the DIVERSA Patent Rights.
1.12 "DIVERSA Field" means (a) Research and Development and (b) the
diagnosis, treatment, prevention or prophylaxis of any human or animal condition
or disease. The DIVERSA Field shall not include any Non-Approved Uses.
1.13 "DIVERSA Patent Rights" means the inventions patentable under
applicable patent law that are claimed in the patent applications and patents
listed on Schedule 1.13(a) hereto and all divisions, continuations,
continuations-in-part, applications claiming priority thereto, and substitutions
thereof; all foreign patent applications corresponding to the preceding
applications; all U.S. and foreign patents issuing on any of the preceding
applications, including extensions, reissues and re-examinations; and any
patents or patent applications, whether now existing or obtained in the future,
owned or controlled by DIVERSA containing a claim that is dominating over the
foregoing patent rights (i.e., is necessarily infringed by the practicing of a
claim in one of the foregoing applications); and any patents or patent
applications covered by any DIVERSA Third Party Licenses, a list of which is set
forth on Schedule 1.13(b).
1.14 "DIVERSA Product" means any composition of matter or article of
manufacture, including without limitation any diagnostic, prophylactic or
therapeutic product, which (a) contains or comprises a Licensed Immunoglobulin;
and/or (b) was discovered, isolated, characterized, or made by any materials or
methods that either claim the benefit of the licenses granted under Article 2 or
would constitute practice of or are otherwise covered by the XOMA Patent Rights
or the XOMA Know-How; and/or (c) contains or comprises an Immunoglobulin and is
made, used or sold by or on behalf of DIVERSA, a DIVERSA Collaborator or a
Development Partner of DIVERSA under conditions which either claim the benefit
of the licenses granted under Article 3 or would constitute practice of or are
otherwise covered by the XOMA Patent Rights or the XOMA Know-How.
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1.15 "DIVERSA Technology Platform" means all know-how, trade secrets,
inventions, data, processes, procedures, devices, methods, formulas, media and
all cell lines, reagents, protocols and other information, whether or not
patentable, relating to biomolecule discovery and biomolecule optimization,
biomolecule expression and/or manufacturing, in each case which are owned by or
licensed to DIVERSA as of the Effective Date and are disclosed to XOMA in
writing and used in connection with a XOMA Project.
1.16 "DIVERSA Third Party Licenses" means those license agreements between
DIVERSA and any Third Party relating to the subject matter of Article 4 of this
Agreement.
1.17 "Dispose" means to transfer, assign, lease, or in any other fashion
dispose of control, ownership or possession, but shall not mean to license or
sell. "Disposition" shall have the correlative meaning.
1.18 "Economic Consideration" means [*] (other than Net Sales on which a
royalty has been paid pursuant to Section 5.5) and shall include [*] and shall
include [*], in each case where any of products, materials, services or
activities of DIVERSA (whether on its own behalf or on behalf of a DIVERSA
Collaborator) produced, provided, rendered or conducted in consideration of such
Economic Consideration claim the benefit of the licenses granted hereunder or
would constitute practice of or are otherwise covered by the XOMA Patent Rights
or the XOMA Know-How, but excluding [*]. All forms of "Economic Consideration"
other than cash shall be valued at their Fair Market Value at the time of
receipt by DIVERSA. If a Third Party makes an equity investment in DIVERSA as
part of such consideration, then [*] shall not be included in Economic
Consideration.
1.19 "Fair Market Value" means the amount which a willing buyer would pay a
willing seller in an arm's length transaction, assuming each party acts with
full knowledge of the facts and without undue pressure or compulsion to complete
such transaction as determined by mutual agreement of the parties hereto in good
faith. For purposes of calculating Fair Market Value, the value of any
securities (whether debt or equity) that are freely tradable in an established
public market will be determined on the basis of the average closing price in
such market during the ten business days prior to the date upon which the
determination is to be made (the "Valuation Period"), and the value of
securities that are not freely tradable (or have no established public market)
or other property will be the fair market value of such securities or other
property upon receipt by DIVERSA as determined in good faith and upon mutual
agreement of XOMA and DIVERSA or, if agreement cannot be reached, as calculated
by a nationally recognized investment bank retained by XOMA, and reasonably
acceptable to DIVERSA, and whose fees shall be shared equally by the parties.
1.20 "First Commercial Sale" means the initial transfer by a Selling Party
(either directly or through a Third Party, including without limitation any
joint venture or similar arrangement in which the Selling Party is a
participant) of a DIVERSA Product or XOMA Development Product, as the case may
be, for value and not for demonstration, testing or promotional purposes.
1.21 "Immunoglobulin" means any molecule, including without limitation,
full immunoglobulin molecules (e.g., IgG, IgM, IgE, IgA and IgD molecules) and
ScFv, Fv and Fab mole-
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cules, that has an amino acid sequence by virtue of which it specifically
interacts with an antigen and wherein that amino acid sequence consists
essentially of a functionally operating region of an antibody variable region
including without limitation any naturally occurring or recombinant form of such
a molecule.
1.22 "Licensed Immunoglobulin" means (a) with respect to the licenses and
rights granted pursuant to Article 2, any Immunoglobulin discovered, isolated or
characterized by DIVERSA through the use of Antibody Evolution, and (b) with
respect to the licenses granted pursuant to Article 3, any Immunoglobulin. For
the avoidance of doubt, for purposes of Sections 5.5(a) and (c) hereof, Licensed
Immunoglobulin includes any Immunoglobulin discovered using Antibody Evaluation
but outside the Manufacturing Field, and for purposes of Sections 5.5(b) and (c)
hereof, Licensed Immunoglobulin includes any Immunoglobulin within the
Manufacturing Field. 1.23 "Licensed Immunoglobulin Information" means any data,
know-how or other information relating, concerning or pertaining to a Licensed
Immunoglobulin, including without limitation data, know-how or other information
characterizing or constituting such Licensed Immunoglobulin's polynucleotide or
amino acid sequence, purported function or utility, antigen binding affinity, or
physical or biochemical property.
1.24 "Manufacturing Field" means the production in prokaryotes of an
Immunoglobulin for the treatment, diagnosis or prophylaxis of a human or animal
disease or condition in quantities which exceed Research Quantities, and shall
include commercial, industrial or clinical scale production.
1.25 "Net Sales" means, solely with respect to sales by a Selling Party
(either directly or through a Third Party, including without limitation any
joint venture or similar arrangement in which such an entity is a participant),
the gross amount invoiced by the Selling Party (or such joint venture or similar
arrangement) to an independent Third Party less the following items:
(a) Trade, cash and quantity discounts actually allowed and taken
directly with respect to such sales;
(b) Excises, sales taxes or other taxes imposed upon and paid directly
with respect to such sales (excluding national, state or local taxes based
income);
(c) Amounts repaid or credited by reason of rejections, defects,
recalls or returns or because of rebates or retroactive price reduction;
and
(d) Freight, transportation and insurance.
1.26 "Non-Approved Uses" means any and all uses not directly related to
Research and Development or the diagnosis, treatment, prevention or prophylaxis
of any human or animal condition or disease and shall expressly include (a)
catalog or on-line sales of cloning or expression vectors, reagents or research
or commercial kits; (b) expression of peptides or polypeptides, including
immunoglobulins or binding fragments thereof, on cell surfaces or viral
surfaces; (c) identification, selection or expression of proteins, reagents,
and/or enzymes or compositions of matter for purely industrial uses or which are
useful in the chemical industry and/or industrial
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manufacturing processes, including without limitation the identification,
selection or expression of catalytic antibodies; and (d) plant science or
agricultural applications.
1.27 "Research and Development" means creation, identification, analysis,
research, characterization or development of actual or potential products
(including, without limitation antibody array or chip). Included within the
definition of "Research and Development", without limiting such definition,
shall be the identification, selection, isolation, purification,
characterization, study and/or testing of an Immunoglobulin and 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.
"Research and Development" shall not include commercial or industrial
manufacture or any activities solely directed to the creation of such
capacities.
1.28 "Research Quantities" means those quantities of an Immunoglobulin
reasonably required for Research and Development purposes.
1.29 "Selling Party" means, as applicable, DIVERSA, a DIVERSA Collaborator
or a Development Partner of DIVERSA or XOMA or a Development Partner of XOMA or
licensee of XOMA.
1.30 "Third Party" means any person or entity other than DIVERSA or XOMA.
1.31 "Valid Claim" means (i) a claim of an issued and unexpired patent
included within the DIVERSA Patent Rights or the XOMA Patent Rights, as the case
may be, which 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, or (ii) a claim of a pending patent application within the DIVERSA
Patent Rights or the XOMA Patent Rights, as the case may be.
1.32 "XOMA Development Product" means any composition of matter or article
of manufacture consisting essentially of an Immunoglobulin or protein discovered
or optimized by DIVERSA for XOMA pursuant to a DIVERSA Action Plan and where
such Immunoglobulin or protein was discovered or optimized using techniques,
methods or materials covered by one or more Valid Claims of any patent or patent
application controlled by DIVERSA, including the DIVERSA Patent Rights.
1.33 "XOMA Know-How" means unpatented and/or unpatentable technical
information, including ideas, concepts, inventions, discoveries, data, designs,
formulas, specifications, procedures for experiments and tests and other
protocols, results of experimentation and testing, fermentation and purification
techniques, and assay protocols, whether now existing or obtained in the future,
owned by XOMA which XOMA has the right to license or sublicense and which may be
necessary for the practice of the XOMA Patent Rights or which would be
misappropriated by the activities of DIVERSA, the DIVERSA Collaborators or the
Development Partners of DIVERSA contemplated hereunder but for this Agreement,
and which are disclosed to DIVERSA under this Agreement. XOMA Know-How shall not
include the XOMA Patent Rights. All XOMA Know-How shall be Confidential
Information of XOMA.
1.34 "XOMA Patent Rights" means the inventions patentable under applicable
patent law that are claimed in the patent applications and patents listed on
Schedule 1.34 hereto and all
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divisions, continuations, continuations-in-part, applications claiming priority
thereto, and substitutions thereof; all foreign patent applications
corresponding to the preceding applications; all U.S. and foreign patents
issuing on any of the preceding applications, including extensions, reissues and
re-examinations; and any patents or patent applications, whether now existing or
obtained in the future, owned or controlled by XOMA containing a claim that is
dominating over the foregoing patent rights (i.e., is necessarily infringed by
the practicing of a claim in one of the foregoing applications).
1.35 "XOMA Technology Platform" means all know-how, trade secrets,
inventions, data, processes, procedures, devices, methods, formulas, media and
all cell lines, reagents, protocols and other information, whether or not
patentable, that either (a) constitute or relate to any biological target,
antigen, receptor, cell, expression vector, disease, condition, nucleic acid,
protein (including, without limitation, an Immunoglobulin) or protein-conjugate
which is the subject of or arises out of any XOMA Project or (b) relate to the
discovery, optimization, expression or manufacture of Immunoglobulins, in each
case which are owned by or licensed to XOMA as of the Effective Date and are
disclosed to DIVERSA or used by DIVERSA or XOMA in connection with a XOMA
Project. For the avoidance of doubt, the term "XOMA Platform Technology" shall
include any prokaryotic expression technology and methods and/or antibody phage
display technology and methods.
The above definitions are intended to encompass the defined terms in both
the singular and plural forms.
ARTICLE 2
XOMA GRANT OF RESEARCH AND DEVELOPMENT RIGHTS TO DIVERSA
2.1 License Grants. Subject to the other terms and conditions of this
Agreement, within the DIVERSA Field, XOMA hereby grants to DIVERSA, a worldwide,
non-exclusive, non-transferable (other than as provided in Section 10.2)
license, without any right to sublicense, under the XOMA Patent Rights and the
XOMA Know-How:
(a) solely on its own behalf, on behalf of any Development Partner of
DIVERSA and on behalf of any DIVERSA Collaborator, to engage in Antibody
Evolution; and
(b) solely on its own behalf, on behalf of any Development Partner of
DIVERSA and on behalf of any DIVERSA Collaborator, to make or have made
Research Quantities of a Licensed Immunoglobulin; and
(c) solely on its own behalf, to transfer Research Quantities of a
Licensed Immunoglobulin or Licensed Immunoglobulin Information to any
DIVERSA Collaborator or a Development Partner of DIVERSA; and
(d) solely on its own behalf and on behalf of any DIVERSA
Collaborator, to sell, offer to sell, import and export Licensed
Immunoglobulins; and
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(e) solely on its own behalf, on behalf of any Development Partner of
DIVERSA and on behalf of any DIVERSA Collaborator, to use Licensed
Immunoglobulins.
For the sake of clarity, the licenses granted in Section 2.1 are personal to
DIVERSA and are to be used on behalf of any DIVERSA Collaborator or Development
Partner of DIVERSA only in respect of or in connection with the activities that
such DIVERSA Collaborator or Development Partner of DIVERSA is engaged in that
are the basis for meeting the definition of DIVERSA Collaborator or Development
Partner of DIVERSA, as the case may be, and not any other activities.
For the sake of clarity, this Section 2.1 shall neither limit nor apply to the
conduct by DIVERSA, on its own behalf or on behalf of any Development Partner of
DIVERSA or any DIVERSA Collaborator or otherwise, of any of the activities
described in subsections (a) through (e) above to the extent that the conduct of
such activities, absent the license granted pursuant to Section 2.1 under the
XOMA Patent Rights and XOMA Know-How, would not infringe any of the XOMA Patent
Rights or result in misappropriation of any of the XOMA Know-How.
2.2 XOMA Transfer to DIVERSA. Within thirty (30) days of the Effective
Date, XOMA shall transfer to DIVERSA, at a mutually agreed place and time, the
materials identified on Schedule 2.2. For the avoidance of doubt, such materials
shall constitute XOMA Know-How. Technology is included in the access fee paid
pursuant to Article 5 and includes up to two person-days of XOMA scientific
staff time at XOMA's facilities prior to February 15, 2004 (which period may be
extended by mutual consent of the parties, which consent shall not be
unreasonably withheld). Thereafter, DIVERSA will be able to consult with XOMA
scientific staff at $2,500/person-day (based on an eight hour day) beyond the
two person-days. The cost of all reasonable travel-related expenses will be
fully reimbursed to XOMA by DIVERSA.
2.3 Covenant Not To Xxx. In partial consideration for the payments set
forth in Sections 5.1, 5.2 and 5.5, XOMA covenants that it shall not initiate or
permit any Third Party over whom it has control to initiate or assist in any way
in the initiation or prosecution of any action asserting a claim of infringement
under the XOMA Patent Rights or misappropriation of the XOMA Know-How against
DIVERSA, any Development Partner of DIVERSA or any DIVERSA Collaborator solely
to the extent reasonably necessary to permit the authorized use of Licensed
Immunoglobulins or Licensed Immunoglobulin Information for activities or in a
manner otherwise permitted under the provisions of this Agreement. The covenant
not to xxx provided by this Section 2.3:
(a) shall not extend to infringement of the XOMA Patent Rights or
misappropriation of the XOMA Know-How arising out of making or the means or
methods used to make any amount of a Licensed Immunoglobulin or DIVERSA
Product other than Research Quantities;
(b) shall become void and without effect as to any entity or person
who claims its benefit but fails to materially discharge or comply with any
term of its written agreement with DIVERSA provided for in Section 2.5;
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(c) is personal to DIVERSA, any such Development Partner of DIVERSA
and any such DIVERSA Collaborator and cannot be assigned or transferred;
(d) does not extend to making, using, selling, having made or
importing antibody phage display materials, Antibody Phage Display or any
compositions of matter or articles of manufacture derived from or arising
out of Antibody Phage Display; and
(e) does not constitute a release or waiver of past, present or future
infringement of the XOMA Patent Rights or misappropriation of the XOMA
Know-How by DIVERSA or any Third Party, including without limitation any
DIVERSA Collaborator acting outside of the scope of the written agreement
with DIVERSA provided for in Section 2.5.
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. No
license or other rights shall be deemed to have been granted to DIVERSA, a
Development Partner of DIVERSA or a DIVERSA Collaborator other than as expressly
provided for in this Agreement. For the avoidance of doubt, the grants of rights
made pursuant to Sections 2.1 and 2.3 do not include, and expressly exclude, the
following:
(a) any right or license to engage in any activities on behalf of or
in collaboration with any Third Party, other than a Development Partner of
DIVERSA or a DIVERSA Collaborator;
(b) any right or license to make or have made any amount, other than
Research Quantities, of a Licensed Immunoglobulin or DIVERSA Product by
practicing the XOMA Patent Rights or the XOMA Know-How; provided, however,
that DIVERSA or, as applicable, a DIVERSA Collaborator or Development
Partner of DIVERSA, shall be permitted to make or have made any Licensed
Immunoglobulin by any means of its selection other than those which
otherwise infringe a Valid Claim of the XOMA Patent Rights or utilize the
XOMA Know-How;
(c) any right to release any Third Party, including a Development
Partner of DIVERSA or a DIVERSA Collaborator, from any claim of
infringement under the XOMA Patent Rights or misappropriation of the XOMA
Know-How;
(d) any right or license under the XOMA Patent Rights or XOMA Know-How
to sell, lease, license, transfer or dispose of the ownership or possession
to a Third Party of any composition of matter or article of manufacture
suitable for the conduct of Antibody Evolution or phage display; and/or
(e) any right or license to use or cause any Third Party to use any
Antibody Phage Display Materials to identify, select, characterize, study
or test a polypeptide, including but not limited to an Immunoglobulin.
2.5 Transfer Restrictions. (a) To the extent the following activities
involve or will involve the practice of any XOMA Patent Rights and/or XOMA
Know-How pursuant to, or any claim to the benefit of, any license or right
granted under this Agreement, DIVERSA shall not
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(i) undertake any Antibody Evolution activities on behalf of a Third Party or
(ii) Dispose of a Licensed Immunoglobulin, Licensed Immunoglobulin Information
with respect to which any license or right under the XOMA Patent Rights or the
XOMA Know-How is granted or the benefit of which is claimed under this Agreement
or the product of the practice of any method within the scope of the XOMA Patent
Rights ("Transferred Materials") to any Third Party until (in the case of either
clause (i) or clause (ii)) such time as it has provided to such Third Party the
redacted copy of this Agreement referred to in Section 6.2 and the Form of
Notice set out as Schedule 2.5.
(b) If DIVERSA enters into a written arrangement with any Third Party
arising out of or relating to activities as to which it or such Third Party does
or intends to claim the benefits of any of the licenses or other grants provided
for by this Agreement, such written arrangement shall contain provisions (i)
pursuant to which the recipient of any Transferred Materials agrees to abide by
each of the limitations, restrictions and other obligations provided for by this
Agreement, including without limitation the restrictions on use of Transferred
Materials for purposes other than Research and Development; (ii) implementing a
covenant not to use Transferred Materials for any purpose other than for
Research and Development purposes otherwise authorized by this Agreement; (iii)
providing that the "first sale" doctrine does not apply to any Disposition; (iv)
permitting a DIVERSA Collaborator or Development Partner of DIVERSA to further
Dispose of Transferred Materials only to a Third Party who otherwise meets the
definition of a DIVERSA Collaborator and who executes a written agreement in
which its undertakes all of the obligations applied to the transferring party;
and (v) permitting DIVERSA to disclose the name, address and contact person for
any DIVERSA Collaborator or Development Partner of DIVERSA to XOMA in accordance
with Section 2.6 (without giving effect to the proviso therein). XOMA shall be,
and the agreements subject to this Section 2.5 shall provide that XOMA shall be,
an intended third party beneficiary with respect to the foregoing provisions.
2.6 Reports, Records and Audits. (a) Forty-five (45) days after the end of
each calendar quarter, commencing with the first calendar quarter commencing
after the Effective Date, DIVERSA shall deliver to XOMA a written report which
shall specify the name, address and contact person for each and every DIVERSA
Collaborator and Development Partner of DIVERSA and any person or entity
receiving Antibody Evolution services or a Licensed Immunoglobulin, in each case
to the extent the activities conducted or to be conducted by DIVERSA for or with
such DIVERSA Collaborator, Development Partner of DIVERSA or other person or
entity involve or will involve any claim to the benefit of any license or right
under XOMA Patent Rights and XOMA Know-How granted under this Agreement;
provided, however, that such disclosure does not violate any confidentiality
obligations that DIVERSA has to such DIVERSA Collaborator or Development Partner
of DIVERSA and any person or entity receiving Antibody Evolution services or a
Licensed Immunoglobulin. The reports delivered by DIVERSA to XOMA pursuant to
this Section 2.6(a) shall be Confidential Information of DIVERSA.
(b) Not later than forty-five (45) days after the end of each calendar
year, commencing with the first calendar year to commence after the Effective
Date, as and to the extent publicly disclosed by DIVERSA (whether in press
releases, government filings or otherwise), DIVERSA shall deliver to XOMA
written materials pertaining to the current status of activities or compositions
of matter as to which DIVERSA claims the right of license hereunder to the
extent that DIVERSA has made public disclosure with respect to such status of
activities or compositions of matter.
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(c) DIVERSA shall maintain records fully and properly reflecting those
activities to be reported to XOMA pursuant to Sections 2.6(a) and (b) (the
"Records"), in sufficient detail and in good scientific manner appropriate for
patent, regulatory and manufacturing purposes for at least three (3) years. Upon
the written request of XOMA and not more than once in each calendar year,
DIVERSA shall permit an independent consultant appointed by XOMA, at XOMA's
expense, to have access during normal business hours to such of the records of
DIVERSA as may be reasonably necessary to verify compliance with the terms of
this Agreement, as well as the accuracy of the reports hereunder. DIVERSA shall
certify any statements by DIVERSA personnel provided to XOMA under this
Agreement as to their accuracy and correctness. The consultant shall enter into
a reasonable confidentiality agreement with DIVERSA. The consultant shall not be
permitted to see or receive any specific information concerning targets or
antibodies of either DIVERSA or any of its collaborators and shall disclose to
XOMA only the results and conclusions of its review and the specific details
concerning any discrepancies. No other information shall be shared by the
consultant without the prior consent of DIVERSA unless disclosure is required by
law, regulation or judicial order.
2.7 Ownership; Enforcement. At all times XOMA will retain ownership of the
XOMA Patent Rights and may use and commercialize such XOMA Patent Rights itself
or with any Third Party. XOMA retains the right, at its sole discretion, to
enforce, maintain and otherwise protect the XOMA Know-How and the XOMA Patent
Rights. In addition to the requirements of Section 2.6, DIVERSA shall give XOMA
prompt notice of any infringement of any of the XOMA Patent Rights by a Third
Party which comes to DIVERSA's attention during the term of this Agreement. At
all times DIVERSA will retain ownership of the DIVERSA Patent Rights and all
DIVERSA Evolution Technologies and the DIVERSA Technology Platform and may use
and commercialize such DIVERSA Patent Rights, DIVERSA Evolution Technologies and
the DIVERSA Technology Platform itself or with any Third Party. DIVERSA retains
the right, at its sole discretion, to enforce, maintain and otherwise protect
the DIVERSA Patent Rights, DIVERSA Evolution Technologies and DIVERSA Technology
Platform.
2.8 Release From Past Infringement. XOMA releases DIVERSA from any claims,
demands, and rights of action arising out of and/or based upon any act or
omission committed by DIVERSA prior to the Effective Date, including without
limitation claims of infringement under the XOMA Patent Rights (the "Release"),
and XOMA releases those Third Parties identified upon Schedule 2.8(i) from any
claims, demands, and rights of action arising out of and based upon any
infringement of the XOMA Patent Rights (the "Third Party Release"); provided,
however, that the Release and Third Party Release provided for in this Section
2.8 shall extend only to claims, demands or rights of action existing as of the
Effective Date and which arose solely out of those activities specified in
Schedule 2.8(ii). Nothing in this Section 2.8 shall be deemed to be a release of
any claim, demand or right of action XOMA may now or in the future have against
[*] or any of their collaborators (except, in the case of any such collaborator
that is also a collaborator of DIVERSA, to the extent such collaborator's
activities with DIVERSA are directly and exclusively within the scope of the
Third Party Release). The Release and the Third Party Release shall become
irrevocable only upon receipt by XOMA of payment in full by DIVERSA of all of
the amounts set forth in Section 5.1 and shall be revoked in their entirety and
null and void ab initio, immediately and without further action of the parties,
in the event any such amount is not received by XOMA on or prior to the date for
payment thereof as set forth in Section 5.1, regardless of any payment received
thereafter.
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ARTICLE 3
XOMA GRANT OF MANUFACTURING LICENSE TO DIVERSA
3.1 Manufacturing License. In addition to the other licenses granted by
this Agreement, XOMA hereby grants to DIVERSA, under the conditions provided for
in this Article 3, a non-exclusive, non-transferable (other than as provided in
Section 10.2) right and license, without the right to sublicense, under the XOMA
Patent Rights and XOMA Know-How, to, solely on its own behalf, make one or more
DIVERSA Products in the Manufacturing Field. DIVERSA shall not practice its
rights under the license granted in this Section 3.1 unless and until DIVERSA
(a) provides XOMA with written notice to the effect that DIVERSA intends to
avail itself of such license and (b) makes the payment provided for in Section
5.3 in accordance with the terms thereof. For the avoidance of doubt, the
license granted under this Section 3.1 includes the right to make DIVERSA
Products which contain or comprise any Immunoglobulin, including any Licensed
Immunoglobulin described in Section 1.22(a), the making of which would, but for
the license granted under this Section 3.1, constitute infringement of the XOMA
Patent Rights or misappropriation of the XOMA Know-How, but expressly excludes
the right to make any such Immunoglobulin (i) with respect to which DIVERSA, at
the time of manufacture, does not have either exclusive ownership or license
rights or the exclusive right to control development and production, and/or (ii)
which, after a reasonable investigation, DIVERSA has or should have reason to
believe was discovered, isolated, characterized, or made by a Third Party
through the use of any materials or methods infringing any of the XOMA Patent
Rights or misappropriating any of the XOMA Know-How.
3.2 No Implied Rights. Only the rights and licenses granted pursuant to the
express terms of this Article 3 shall be of any legal force or effect with
respect to activities within the Manufacturing Field, and the grant of rights
pursuant to Section 3.1 shall confer no right or license to engage in any of the
activities covered by Article 2, including without limitation Research and
Development or Antibody Evolution. The rights and license granted by this
Article 3 shall be read as being separate and independent from the licenses and
rights granted pursuant to Article 2.
ARTICLE 4
DIVERSA GRANT OF RIGHTS TO XOMA
4.1 Covenant Not To Xxx. DIVERSA covenants that it shall not assert any
claims or permit any Third Party over whom it has control to initiate or assist
in any way in the initiation or prosecution of any action asserting a claim of
infringement under the DIVERSA Patent Rights against XOMA or any Development
Partner of XOMA in the course of the development of molecules by or on behalf of
XOMA, solely to the extent such claims arise out of the discovery, isolation,
optimization or development by XOMA or the development (but not discovery or
optimization for discovery) by a Development Partner of XOMA, or the
manufacture, use, offer for use, sale, offer for sale, importation and
exportation by XOMA or such Development Partner of XOMA, of any Immunoglobulin
or product containing or comprising an Immunoglobulin which was discovered by
XOMA under conditions which would otherwise constitute misappropriation or
infringement of the DIVERSA Patent Rights; provided however, that such
Immunoglobulin or
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product containing or comprising such Immunoglobulin was not made, discovered,
isolated, optimized or developed using the DIVERSA Evolution Technologies, it
being understood that nothing in this proviso shall limit XOMA's rights with
respect to bacterial expression of proteins or Antibody Phage Display unrelated
to the DIVERSA Technology Platform.
4.2 No Implied Rights. Only the rights granted pursuant to the express
terms of Section 4.1 of this Agreement shall be of any legal force or effect
under this Agreement with respect to the DIVERSA Patent Rights. No license or
other rights shall be deemed to have been granted to XOMA or any Development
Partner of XOMA under this Agreement, other than as expressly provided for in
this Agreement. For the avoidance of doubt, the grants of rights made pursuant
to Section 4.1 do not include, and expressly exclude, the following:
(a) any right or license to engage in a Commercial Antibody Evolution
Business;
(b) any right or license to engage in any activities on behalf of or
in collaboration with any Third Party (other than a Development Partner of
XOMA);
(c) any right to release any Third Party, including a Development
Partner of XOMA, from any claim of infringement under the DIVERSA Patent
Rights; or
(d) any right to use the DIVERSA Evolution Technologies, or any
library or Immunoglobulin derived from the use of the DIVERSA Evolution
Technologies (except as set forth herein for the XOMA Projects).
4.3 XOMA Development Projects. (a) During the period commencing on the
Effective Date and ending [*] thereafter (the "Collaborative Period"), upon the
prior written notice of XOMA and upon the terms provided for by this Section
4.3, for up to [*] different projects (each a "XOMA Project"), DIVERSA shall be
obligated to initiate and undertake a scientific collaboration with XOMA in
order to, as applicable, discover or identify proteins or Immunoglobulins with
characteristics specified by XOMA and/or to apply any technology then under
DIVERSA's control to compositions of matter of XOMA's selection, including to
optimize, evolve or otherwise alter any Immunolgobulin, protein or nucleic acid
encoding such Immunoglobulin or protein. XOMA shall, upon the Effective Date, be
deemed to have provided its first notice of a XOMA Project by the provision of
the XOMA Project Plan (as defined below) annexed hereto as Schedule 4.3(a). Upon
the termination of the Collaborative Period, XOMA and DIVERSA, on the other
terms provided for herein, shall, with each party's written consent, be free to
undertake other activities relating to additional XOMA Targets (as defined
below) in addition to the [*] XOMA Projects provided for by this Agreement.
Unless otherwise agreed by XOMA and DIVERSA, there shall be no more than [*]
XOMA Projects in implementation at any given time.
(b) A XOMA Project shall be deemed to have commenced upon the date XOMA
delivers to DIVERSA a written document (the "XOMA Project Plan") that sets forth
the composition of matter or article of manufacture which shall form the subject
matter of the collaboration (the "XOMA Target"). Each XOMA Project Plan shall
specify the goals of the collaboration, the anticipated technologies within the
DIVERSA Technology Platform and services expected to be provided to XOMA by
DIVERSA as part of the collaboration, the criteria to be used by
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XOMA to determine when, and if, the application of the DIVERSA Technology
Platform and services have been successful (the "Success Criteria") and an
estimated timeline by which the Success Criteria are to be met. Within [*] days
of the submission, at DIVERSA's request, XOMA shall provide such written
technical and other information that are reasonably necessary for DIVERSA to
assess the technical requirements of the XOMA Project Plan.
(c) Within [*] days of the provision of the XOMA Project Plan, DIVERSA
shall provide to XOMA a written plan (the "DIVERSA Action Plan") setting forth
with particularity the specific technologies within the DIVERSA Technology
Platform to be used and actions to be undertaken by DIVERSA (or as applicable
its subcontractors) to achieve the goals of the collaboration specified in the
XOMA Project Plan. Within [*] days of the receipt of the DIVERSA Action Plan,
XOMA shall comment on and either approve or, after good faith negotiations with
DIVERSA, modify and approve the DIVERSA Action Plan. DIVERSA may refuse to
undertake a XOMA Project only if (i) the XOMA Target is the subject of a
pre-existing exclusive arrangement with a Third Party which specifically refers
to or relates to the XOMA Target, (ii) the XOMA Target is the subject of a bona
fide internal development program at DIVERSA initiated prior to disclosure to
DIVERSA of the XOMA Target by XOMA, or (iii) in the reasonable judgment of
DIVERSA it cannot achieve the goals of the collaboration provided for by the
XOMA Project Plan or a modified DIVERSA Action Plan. In the event that DIVERSA
refuses any XOMA Project Plan or any reasonable changes to a DIVERSA Action
Plan, the XOMA Project as to which the refusal has occurred shall be deemed not
to have commenced and shall not be counted as a XOMA Project for purposes of the
other provisions of this Section 4.3, and the Collaborative Period shall be
extended by [*] days. At any time prior to the commencement of the activities
contemplated by the DIVERSA Action Plan, XOMA may cancel such XOMA Project and
such cancelled XOMA Project shall be deemed not to have commenced and shall not
be counted as a XOMA Project for purposes of the other provisions of this
Section 4.3. Each XOMA Project shall be conducted in accordance with the
applicable provisions of this Agreement. Each DIVERSA Action Plan shall set
forth a set of deliverables, timelines, a good faith estimate of the total
DIVERSA Direct Costs for implementation of such DIVERSA Action Plan and a
reasonable estimate of the anticipated costs of providing any other services or
technologies set out in such DIVERSA Action Plan. It is understood that each
DIVERSA Action Plan, and the cost estimates associated with it, will vary
depending on the specific needs of the project. However, for reference, DIVERSA
Action Plans on optimization projects will generally require an effort
equivalent to [*] FTEs and DIVERSA Action Plans on antibody generation will
generally require an effort equivalent to [*] FTEs. For each DIVERSA Action Plan
(other than the first one), DIVERSA shall specify by name, job title and
seniority the key DIVERSA employees allocated to perform the applicable DIVERSA
Action Plan. To the extent reasonably feasible, DIVERSA shall allocate those
personnel with the necessary experience and skill, relative to their seniority,
to accomplish such task in the most efficient manner. Following approval by XOMA
of a DIVERSA Action Plan and taking into consideration the activities to be
performed and the timelines with respect thereto, XOMA will specify a date by
which either the Success Criteria shall be met or, in the event the Success
Criteria shall not be met by such date and XOMA is otherwise complying with all
of its obligations hereunder with respect to such XOMA Project, such XOMA
Project shall be deemed not to have commenced and shall not be counted as a XOMA
Project for purposes of the other provisions of this Section 4.3, and the
Collaborative Period shall be extended by the number of days elapsed from
commencement of the XOMA Project to the date the Success Criteria are deemed not
to have been met, up to [*] days; provided,
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that (A) notwithstanding the foregoing, the first XOMA Project shall be deemed
to have commenced regardless of any such failure to timely meet Success Criteria
and (B) any number of XOMA Projects terminated in reliance on this sentence in
excess of [*] shall be counted against the [*] XOMA Projects DIVERSA is
obligated to undertake pursuant hereto.
(d) Immediately upon XOMA acceptance in writing of a DIVERSA Action Plan,
DIVERSA shall use commercially reasonable and diligent efforts to commence and
complete the activities provided for therein at the times specified therefor and
shall undertake such activities and any other activities required to meet the
goals of the collaboration as set forth in the applicable XOMA Project Plan with
the same level of skill, resources and personnel as it would apply to a similar
project undertaken on its own behalf. For each quarter of a XOMA Project,
DIVERSA, with the consultation and approval of XOMA, shall, as necessary, update
and revise the applicable XOMA Action Plan, DIVERSA Action Plan and the
associated cost estimates and timelines associated therewith. With respect to
each XOMA Project, DIVERSA shall not discriminate against the XOMA Project in
favor of any Third Party or any of its own internal projects with respect to the
application of any techniques or know-how or access to technology or skilled
personnel. DIVERSA shall represent and warrant that its activities, the
materials and methods used by DIVERSA and any Project Materials provided to XOMA
shall be free of claims of patent infringement or misappropriation by any Third
Party. DIVERSA shall use its commercially reasonable efforts to complete the
activities required by the DIVERSA Action Plan in the time provided for therein,
provided, however, that DIVERSA shall not be deemed to have failed to meet a
timeline if the failure is directly attributable to an action or inaction by
XOMA. The Collaboration Period shall be extended by an amount of time equal to
the amount of each extension of time granted to DIVERSA under a DIVERSA Action
Plan.
(e) All data, results and materials of experimentation, testing, techniques
and protocols arising out of or directly relating to a XOMA Project, including
methods and protocols developed solely for purposes of a XOMA Project (the
"Project Materials") shall be owned solely and exclusively by XOMA, provided,
however, that, (i) any intellectual property rights arising from a XOMA Project
shall be governed by and handled in accordance with Section 4.3(f), and (ii)
DIVERSA, under reasonable conditions necessary to protect XOMA's interest in the
Project Materials, shall be allowed to use know-how in support of any patent
filings permitted under Section 4.3(f). DIVERSA shall establish internal
procedures to insure that access to Project Materials is safeguarded from Third
Parties or any DIVERSA employees not directly working on the XOMA Project.
(f) All intellectual property rights which are in the possession of each
party as of the Effective Date, including, without limitation, the XOMA Patent
Rights and the DIVERSA Patents Rights, as applicable, shall remain in the
possession of that party. With respect to each XOMA Project, DIVERSA shall
disclose to XOMA all inventions, whether patentable or not, conceived of by
DIVERSA, its employees or consultants, whether jointly or solely, as a result of
activities performed or to be performed in connection with the XOMA Project or
pursuant to the applicable DIVERSA Action Plan or disclosures of or access to
the XOMA Technology Platform to DIVERSA (collectively, the "DIVERSA
Inventions"); provided, that any DIVERSA Inventions owned solely by DIVERSA
hereunder that are not subject to any obligation hereunder to assign or license
to XOMA and are not to be included pursuant hereto in the definition of DIVERSA
Patent Rights shall not be required to be disclosed to XOMA. With respect to
each
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XOMA Project, XOMA shall disclose to DIVERSA all inventions, whether patentable
or not, conceived of by XOMA, its employees or consultants, whether jointly or
solely, as a result of disclosures of or access to the DIVERSA Technology
Platform to XOMA in connection with the XOMA Project (collectively, the "XOMA
Inventions" and, together with the DIVERSA Inventions, the "Inventions"),
provided, however, that XOMA shall be under no obligation to disclose to DIVERSA
any XOMA Invention relating to any biological target, antigen, receptor, cell,
expression vector, disease, condition, nucleic acid, protein (including, without
limitation, an Immunoglobulin) or protein-conjugate which is the subject matter
of a XOMA Project. Inventorship of Inventions shall be determined in accordance
with United States patent law. Ownership of Inventions shall be determined as
follows:
(i) Inventions which are improvements or modifications to the DIVERSA
Technology Platform made by DIVERSA shall be owned solely by DIVERSA;
(ii) Inventions which are improvements or modifications to the XOMA
Technology Platform shall be owned solely by XOMA, but, as applicable,
shall, to the extent they relate directly to bacterial expression of
Immunoglobulins, be automatically included in the definition of XOMA Patent
Rights;
(iii) Inventions which are proteins, immunoglobulins or nucleic acids
evolved by DIVERSA under the XOMA Projects starting from any biological
target, antigen, receptor, cell, expression vector, disease, condition,
nucleic acid, protein (including, without limitation, an Immunoglobulin) or
protein-conjugate that is proprietary to XOMA shall be solely owned by
XOMA; provided that XOMA has made all applicable payments to DIVERSA under
this Agreement; and
(iv) All other Inventions shall be owned by XOMA, provided, however,
that to the extent such Inventions relate to the DIVERSA Evolution
Technologies or the DIVERSA Technology Platform, XOMA shall grant to
DIVERSA a non-exclusive, royalty-free, worldwide, perpetual, irrevocable
license to practice such patents as part of the DIVERSA Evolution
Technologies or the DIVERSA Technology Platform. In addition, such license
shall be sublicensable, except in cases where any Invention covered by such
license relates to the XOMA Patent Rights, in which case it shall not be
sublicensable.
Each party shall make such assignments and take such other actions as may
be necessary or appropriate to effect the ownership of intellectual property
rights in accordance with this Section 4.3(f). Each party shall be responsible
for the filing, prosecution, maintenance, defense or enforcement and any costs
associated therewith of any right or interest owned solely by such party as set
forth above.
(g) DIVERSA shall grant to XOMA and any XOMA Development Partner of whom
XOMA provides written notice to DIVERSA an exclusive, worldwide, royalty-bearing
license and right under the DIVERSA Patent Rights and/or any other patents,
patent applications or intellectual property owned or licensed by DIVERSA (with
the right to license or sublicense), which claim or cover a given XOMA
Development Product or its manufacture or use to make, have made, use, sell,
offer to sell, import, export, develop, commercialize and manufacture such XOMA
Development Product. During the pendency of each XOMA Project and for a period
of
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[*] thereafter, DIVERSA covenants that it will not conduct any activities on its
own behalf or on behalf of a Third Party which relates to or encompasses the
XOMA Target that is the subject of such XOMA Project. Solely as it relates to
each XOMA Development Product, DIVERSA covenants that it shall not grant to any
Third Party any rights or licenses under the DIVERSA Patent Rights or any other
patent, patent application or intellectual property right owned or licensed by
DIVERSA (with the right to license or sublicense), which claim or cover such
XOMA Development Product or its manufacture or use, to make, have made, use,
sell, offer to sell, import, export, develop, commercialize and manufacture such
XOMA Development Product.
(h) For each XOMA Project, except the first XOMA Project as described in
the XOMA Project Plan set forth as Schedule 4.3(a), XOMA and DIVERSA shall [*]
for activities undertaken by XOMA pursuant to the applicable DIVERSA Action
Plan; provided, however, that XOMA shall not be obligated to pay its share of
any DIVERSA Direct Costs that exceed [*] percent ([*] %) of the estimate of
costs provided for as part of any applicable DIVERSA Action Plan. For the first
XOMA Project, DIVERSA shall bear [*] of the costs associated with the applicable
DIVERSA Action Plan, except for [*] United States Dollars (US$[*]) of such
costs. For purposes of determining the sharing of costs for all XOMA Projects
after the first one, XOMA's costs shall be calculated on the same FTE basis as
set for DIVERSA (i.e., US$[*]). Upon DIVERSA's provision of a written statement
providing reasonable detail for the amounts expended, XOMA shall reimburse
DIVERSA on an annual basis for any DIVERSA Direct Costs expended during that
applicable calendar year which exceed [*] percent ([*] %) of the costs
associated with all DIVERSA Action Plans expended by the parties during that
applicable calendar year. The parties shall each create and maintain sufficient
records to provide back up for any amount to be so reimbursed or deducted by
XOMA. The record-keeping and inspection provisions of Section 5.10 shall apply
to both parties with respect to any XOMA Project.
(i) On a XOMA Project by XOMA Project basis, for the first XOMA Development
Product arising out of a particular XOMA Project (but not any other XOMA
Development Product arising out of such XOMA Project, unless the first XOMA
Development Product arising out of such XOMA Project is discontinued prior to
achievement of the applicable event, in which case such events and payments
shall apply to any subsequent XOMA Development Product arising out of such XOMA
Project that replaces such first XOMA Development Product), XOMA shall pay to
DIVERSA the applicable milestones and royalties as set forth in the following
table:
Each Successive
Applicable Payment First XOMA Project XOMA Project
Achievement of Success Criteria US$[*] US$[*]
from the applicable XOMA Project
Filing of the first Investigational US$[*] US$[*]
New Drug Application pursuant to
Title 21 of the Code of Federal
Regulations
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Each Successive
Applicable Payment First XOMA Project XOMA Project
Enrollment of the last patient in US$[*] US$[*]
the first Phase III clinical trial
First approval by the Food and Drug US$[*] US$[*]
Administration of a Biologics
License Application
(j) With respect to any XOMA Development Product sold by or on behalf of
XOMA, a Development Partner of XOMA or a licensee of such XOMA Development
Product and as to which DIVERSA, pursuant to a DIVERSA Action Plan, discovered a
novel Immunoglobulin or protein without first being provided the amino acid
sequence or nucleic acid sequence of a pre-existing Immunoglobulin or protein,
XOMA shall pay to DIVERSA a royalty in cash equal to [*] percent ([*] %) of the
Net Sales in each calendar quarter, commencing with the first calendar quarter
ending after the First Commercial Sale of such a XOMA Development Product. With
respect to any XOMA Development Product sold by or on behalf of XOMA, a
Development Partner of XOMA or a XOMA licensee of such XOMA Development Product
and as to which DIVERSA, pursuant to a DIVERSA Action Plan, optimized an
Immunoglobulin or protein provided to it, XOMA shall pay to DIVERSA a royalty in
cash equal to [*] percent ([*] %) of the Net Sales in each calendar quarter,
commencing with the first calendar quarter ending after the First Commercial
Sale of such a XOMA Development Product. Each XOMA Development Product will be
subject only to either a [*] percent ([*] %) or [*] percent ([*] %) royalty and
not both. For the avoidance of doubt, the royalty obligation provided for herein
shall extend to and cover XOMA Development Products subject to this Agreement
and sold by any Development Partner of DIVERSA or DIVERSA Collaborator,
provided, however, that there shall be only one royalty obligation with respect
thereto. Royalties due under this Section 4.3(j) shall be payable on a
country-by-country and XOMA Development Product by XOMA Development Product
basis from the First Commercial Sale of such XOMA Development Product until the
expiration of the last-to-expire DIVERSA Patent Right in such country with
respect to which a Valid Claim covers the manufacture, use, sale, offer for
sale, import or export of such XOMA Development Product or the [*] ([*])
anniversary of such First Commercial Sale, whichever is later.
(k) In the event that, after good faith consultation with DIVERSA and the
provision of an opinion of reputable patent counsel supporting the need to
obtain such a license, XOMA must obtain a license from one or more Third Parties
in order to make, have made, use, sell, offer, import, develop and commercialize
a XOMA Development Product then solely as to such XOMA Development Product, as
applicable, in each quarter, XOMA or XOMA Licensee shall be entitled to a credit
equal to [*] percent ([*] %) of the amount of royalties above [*] percent ([*]
%) of Net Sales actually paid to such Third Party under a bona fide and arms
length license, provided, however, that in no event shall the total royalty
amount due to DIVERSA be reduced by more than [*] percent ([*] %).
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(l) With respect to each XOMA Project that XOMA may decide, in its
discretion, not to progress internally, XOMA hereby grants DIVERSA a first
option to negotiate to acquire or license rights to such XOMA Project, for
consideration acceptable to XOMA, for a period of [*] days after XOMA's notice
to DIVERSA hereunder of such decision (which notice XOMA shall promptly make
following such decision). XOMA agrees to enter into good faith negotiations with
DIVERSA regarding the same during such [*] -day period upon DIVERSA's notice to
XOMA that it is exercising such option (which notice DIVERSA shall promptly make
following notice from XOMA if, in DIVERSA's discretion, DIVERSA decides to
exercise such option).
ARTICLE 5
PAYMENTS
5.1 Technology Access and Release Fee. In consideration for the rights
granted to DIVERSA, DIVERSA Collaborators and Development Partners of DIVERSA
pursuant to Sections 2.1, 2.2, 2.3 and 2.8, DIVERSA shall pay XOMA a fee of [*]
United States Dollars (US$[*]), payable in cash by wire transfer in three (3)
installments as follows: one installment of [*] United States Dollars (US$[*])
to be made by December 26, 2003, and two equal installments of [*] United States
Dollars (US$[*]) each, the first to be made on or before March 15, 2004 and the
second to be made on or before December 15, 2004.
5.2 Annual Maintenance Fee. On each of the first [*] anniversaries of the
Effective Date, DIVERSA shall pay XOMA an annual maintenance fee of [*] United
States Dollars (US$[*]), payable in cash by wire transfer.
5.3 Manufacturing License Fee. In consideration for the rights granted to
DIVERSA pursuant to Section 3.1, DIVERSA shall pay XOMA a fee of [*] United
States Dollars (US$[*]), payable in cash by wire transfer within ten (10)
business days following delivery to XOMA of the notice described in the second
sentence of Section 3.1.
5.4 Manufacturing Milestone Payments. With respect to each DIVERSA Product
within the Manufacturing Field, within thirty (30) days following the
achievement by DIVERSA of the following milestones with respect to each DIVERSA
Product, DIVERSA shall pay to XOMA the applicable payments below:
Event Payment
Initiation (i.e., dosing of a first human US$[*]
patient) of a first Phase I trial
Initiation (i.e., dosing of a first human US$[*]
patient) of a first Phase III or other pivotal
trial
Regulatory approval (NDA or BLA) for marketing US$[*]
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5.5 Royalties. (a) With respect to any DIVERSA Product sold by or on behalf
of DIVERSA, a DIVERSA Collaborator and/or a Development Partner of DIVERSA which
meets the definitions in Sections 1.14(a), 1.14(b) and 1.22(a) (any such DIVERSA
Product, an "Article 2 Product") but is not an Article 3 Product (as defined
below), DIVERSA shall pay to XOMA a royalty in cash equal to [*] percent ([*] %)
of the Net Sales of such DIVERSA Product in each calendar quarter, commencing
with the first calendar quarter ending after the Effective Date. Solely with
respect to the royalty due pursuant to this Section 5.5(a), the applicable
royalty rate provided for herein shall be reduced by [*] percent ([*] %) if, and
only if, the applicable DIVERSA Product consists entirely of a DIVERSA Product
which arose entirely from the use of DIVERSA Patent Rights to optimize or alter
a pre-defined characteristic of a pre-existing Immunoglobulin or protein,
provided, however, that notwithstanding any other provision of this Agreement,
no other deduction from the applicable royalty shall be applied. By way of
example, the reduction provided for in the prior sentence of this Section 5.5(a)
does not apply to any composition of matter or article of manufacture arising in
part or in whole from the identification of such a composition of matter or
article of manufacture by the screening a library or collection of proteins or
Immunoglobulins or a gene library encoding such proteins or Immunoglobulins. For
the avoidance of doubt, the royalty obligations provided for herein shall extend
to and cover DIVERSA Products subject to this Agreement and sold by any
Development Partner of DIVERSA or DIVERSA Collaborator.
(b) With respect to any DIVERSA Product sold by or on behalf of DIVERSA
which meets the definitions in Sections 1.14(a), 1.14(c) and 1.22(b) (any such
DIVERSA Product, an "Article 3 Product") but is not an Article 2 Product,
DIVERSA shall pay to XOMA a royalty in cash equal to [*] percent ([*] %) of the
Net Sales of such DIVERSA Product in each calendar quarter, commencing with the
first calendar quarter ending after the Effective Date.
(c) With respect to any DIVERSA Product sold by or on behalf of DIVERSA, a
DIVERSA Collaborator and/or a Development Partner of DIVERSA which is both an
Article 2 Product and an Article 3 Product, DIVERSA shall pay to XOMA a royalty
in cash equal to [*] percent ([*] %) of the Net Sales in each calendar quarter,
commencing with the first calendar quarter ending after the Effective Date.
(d) Royalties due under this Article 5 shall be payable on a
country-by-country and DIVERSA Product-by-DIVERSA Product basis from the First
Commercial Sale of such DIVERSA Product until the expiration of the
last-to-expire XOMA Patent Right in such country with respect to which a Valid
Claim covers the manufacture, use, sale, offer for sale, import or export of
such DIVERSA Product or the [*] ([*]) anniversary of such First Commercial Sale,
whichever is later.
(e) In the event that DIVERSA, a DIVERSA Collaborator or a Development
Partner of DIVERSA must obtain a license from one or more Third Parties in order
to practice the XOMA Patent Rights or XOMA Know-How in the manner authorized by
this Agreement, and after good faith consultation with XOMA and the provision of
an opinion of reputable patent counsel supporting the need to obtain such a
license from such Third Party, then solely as to any DIVERSA Product that
DIVERSA, such DIVERSA Collaborator or such Development Partner of DIVERSA, as
the case may be, otherwise pays royalties to XOMA for under this Agreement,
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as applicable, in each quarter, DIVERSA, such DIVERSA Collaborator or such
Development Partner of DIVERSA shall be entitled to a credit equal to [*]
percent ([*] %) of the amount of royalties above [*] percent ([*] %) of Net
Sales actually paid to such Third Party or Third Parties under a bona fide and
arm's length license or licenses; provided, however, that in no event shall the
total royalty amount due to XOMA under this Article 5 be reduced by more than
[*] percent ([*] %) of the amounts set forth in clause (a), (b) or (c) of
Section 5.5; and provided, further, that DIVERSA, any DIVERSA Collaborators and
any Development Partners of DIVERSA shall be entitled to only credit royalties
paid to one or more Third Parties related to bacterial expression of
Immunoglobulins relating to patents or patent applications covering the means of
bacterial expression disclosed in the XOMA Patent Rights. Nothing in this
Section 5.5(e) shall entitle DIVERSA, a DIVERSA Collaborator or a Development
Partner of DIVERSA to credit royalties paid to one or more Third Parties for
patents or patent applications covering any specific composition of matter or
method of diagnosis or treatment of a disease, disorder or condition.
5.6 Economic Consideration. Effective beginning July 1, 2003 and throughout
the term of this Agreement, DIVERSA shall pay to XOMA [*] percent ([*] %) of any
Economic Consideration paid to DIVERSA as a result of any activities under this
Agreement (other than on behalf of XOMA pursuant to Article 4) as to which
DIVERSA does not otherwise pay a royalty.
5.7 Commercially Reasonable Efforts. DIVERSA will use its commercially
reasonable efforts to conduct Antibody Evolution and otherwise exploit the XOMA
Patent Rights.
5.8 Payments to XOMA; Currency. Notwithstanding anything in this Agreement
to the contrary, DIVERSA will not be obligated to make any payment to XOMA under
Sections 5.4 and 5.5 with respect to any DIVERSA Product which was discovered,
isolated, characterized and made without use of any materials or methods that
constitute the practice of or are otherwise covered by the XOMA Patent Rights or
the XOMA Know-How, and DIVERSA will not be obligated to make any payment to XOMA
under Section 5.6 with respect to any Economic Consideration received by or due
to DIVERSA in consideration of products, materials, services or activities of
DIVERSA which do not constitute the practice of and are not otherwise covered by
the XOMA Patent Rights or the XOMA Know-How unless DIVERSA made available to the
Third Party that paid such Economic Consideration the benefit of the licenses
and/or rights granted under Articles 2 and/or 3 in conjunction or concurrently
with producing, providing, rendering or conducting such products, materials,
services or activities. All payments due hereunder shall be paid by wire
transfer in United States dollars in immediately available funds to an account
designated by XOMA. Payments required pursuant to Section 5.4 hereof shall be
due and payable to XOMA when the corresponding milestones are achieved and shall
be paid within thirty (30) days thereof. Payments required pursuant to Section
5.5 hereof shall be due and payable to XOMA when the corresponding Net Sales are
received by DIVERSA (or any joint venture or similar arrangement in which
DIVERSA is a participant) and shall be paid within thirty (30) days of the end
of each calendar quarter. Payments required pursuant to Section 5.6 hereof shall
be due and payable to XOMA when the corresponding Economic Consideration is
received by DIVERSA and shall be paid within thirty (30) days of the end of each
calendar quarter. If any currency conversion shall be required in connection
with the payment of any royalties hereunder, such conversion shall be made by
using the exchange rate for the purchase of U.S. dollars quoted in the U.S.
version of the Wall Street Journal on the last business day of the calendar
quarter to which such payments relate.
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5.9 Payment Reports to XOMA. DIVERSA shall make a written report to XOMA
within thirty (30) days of the achievement of each of the milestones set forth
in Section 5.4 with respect to each DIVERSA Product, stating in each such report
the DIVERSA Product to which such milestone relates and the specific milestone
achieved, including the relevant agency or other regulatory body. After the
First Commercial Sale of a DIVERSA Product on which royalties are required to be
paid hereunder, DIVERSA shall make quarterly written reports to XOMA within
thirty (30) days after the end of each calendar quarter, stating in each such
report, by country, the number, description, and aggregate Net Sales of each
DIVERSA Product sold during the calendar quarter. Concurrently with the making
of such reports, DIVERSA shall pay XOMA the amounts specified in Section 5.5
hereof. After receipt by DIVERSA of its first payment of Economic Consideration,
DIVERSA shall make quarterly written reports to XOMA within thirty (30) days
after the end of each calendar quarter, stating in each such report, by country,
the nature of such Economic Consideration and the arrangement to which such
consideration relates. Concurrently with the making of such reports, DIVERSA
shall pay XOMA the amounts specified in Section 5.6 hereof. XOMA shall treat all
reports delivered pursuant to this Section 5.9 as Confidential Information of
DIVERSA.
5.10 Payment Records and Inspection. DIVERSA shall keep complete, true and
accurate books of account and records for the purpose of determining the amounts
payable under this Agreement. Such books and records shall be kept at the
principal place of business of DIVERSA for at least [*] following the end of the
calendar quarter to which they pertain. Upon the written request of XOMA and not
more than once in each calendar year, DIVERSA shall permit an independent
consultant appointed by XOMA and reasonably acceptable to DIVERSA to have access
during normal business hours to such of the records of DIVERSA as may be
reasonably necessary to verify the accuracy of the royalty reports hereunder for
any year ending not more than [*] prior to the date of such request, unless a
discrepancy is found. The consultant shall disclose to XOMA only the results and
conclusions of its review and the specific details concerning any discrepancies.
No other information shall be shared by the consultant without the prior consent
of DIVERSA unless disclosure is required by law, regulation or judicial order.
Inspections conducted under this Section 5.10 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 promptly by DIVERSA.
Any underpayments or unpaid amounts discovered by such inspections or otherwise
will be paid promptly by DIVERSA, with interest from the date(s) such amount(s)
were due at a rate equal to the lesser of the prime rate reported by the Bank of
America plus two percent (2%) or the highest interest rate permitted under
applicable law.
5.11 Payments to DIVERSA; Currency. All payments due hereunder shall be
paid by wire transfer in United States dollars in immediately available funds to
an account designated by DIVERSA. Payments required pursuant to Section 4.3(i)
hereof shall be due and payable to DIVERSA when the corresponding milestones are
achieved and shall be paid within thirty (30) days thereof. Payments required
pursuant to Section 4.3(j) hereof shall be due and payable to DIVERSA when the
corresponding Net Sales are received by XOMA (or any joint venture or similar
arrangement in which XOMA is a participant) and shall be paid within thirty (30)
days of the end of each calendar quarter. If any currency conversion shall be
required in connection with the payment of any royalties hereunder, such
conversion shall be made by using the exchange
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rate for the purchase of U.S. dollars quoted in the U.S. version of the Wall
Street Journal on the last business day of the calendar quarter to which such
payments relate.
5.12 Payment Reports to DIVERSA. XOMA shall make a written report to
DIVERSA within thirty (30) days of the achievement of each of the milestones set
forth in Section 4.3(i) with respect to each XOMA Development Product, stating
in each such report the XOMA Development Product to which such milestone relates
and the specific milestone achieved, including the relevant agency or other
regulatory body. After the First Commercial Sale of a XOMA Development Product
on which royalties are required to be paid hereunder, XOMA shall make quarterly
written reports to DIVERSA within thirty (30) days after the end of each
calendar quarter, stating in each such report, by country, the number,
description, and aggregate Net Sales of each XOMA Development Product sold
during the calendar quarter. Concurrently with the making of such reports, XOMA
shall pay DIVERSA the amounts specified in Section 4.3(j) hereof. DIVERSA shall
treat all reports delivered pursuant to this Section 5.12 as Confidential
Information of XOMA.
5.13 Payment Records and Inspection. XOMA shall keep complete, true and
accurate books of account and records for the purpose of determining the amounts
payable under this Agreement. Such books and records shall be kept at the
principal place of business of XOMA for at least [*] following the end of the
calendar quarter to which they pertain. Upon the written request of DIVERSA and
not more than once in each calendar year, XOMA shall permit an independent
consultant appointed by DIVERSA and reasonably acceptable to XOMA to have access
during normal business hours to such of the records of XOMA as may be reasonably
necessary to verify the accuracy of the royalty reports hereunder for any year
ending not more than [*] prior to the date of such request, unless a discrepancy
is found. The consultant shall disclose to DIVERSA only the results and
conclusions of its review and the specific details concerning any discrepancies.
No other information shall be shared by the consultant without the prior consent
of XOMA unless disclosure is required by law, regulation or judicial order.
Inspections conducted under this Section 5.13 shall be at the expense of
DIVERSA, 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 promptly by
XOMA. Any underpayments or unpaid amounts discovered by such inspections or
otherwise will be paid promptly by XOMA, with interest from the date(s) such
amount(s) were due at a rate equal to the lesser of the prime rate reported by
the Bank of America plus two percent (2%) or the highest interest rate permitted
under applicable law.
ARTICLE 6
CONFIDENTIALITY
6.1 Confidential Information. Except as expressly provided herein, the
parties agree that, for the term of this Agreement and for five (5) 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 to the extent that it can be
established by the receiving party by written proof that such Confidential
Information:
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(a) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure other than through any act or omission
of the receiving party in breach of this Agreement;
(d) was subsequently lawfully disclosed to the receiving party by a
person other than a party hereto; or
(e) was independently developed by DIVERSA or XOMA, as the case may
be, without reference or access to the Confidential Information of the
other party.
6.2 Permitted Use and Disclosures. 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
government regulations or conducting clinical trials; provided, however, 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 efforts to secure confidential treatment of such information
prior to its disclosure (whether through protective orders or otherwise).
Attached hereto as Schedule 6.2 is a redacted copy of this Agreement which
DIVERSA shall be free, without obtaining any consent from XOMA, to provide to
Third Parties who indicate an interest in becoming a DIVERSA Collaborator or a
Development Partner of DIVERSA.
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, that disclosures may be made as
required by securities or other applicable laws, or to a party's accountants,
attorneys and other professional advisors.
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 and that 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.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
7.1 Representations and Warranties. (a) XOMA represents and warrants to
DIVERSA that: (i) it is the sole and exclusive owner or exclusive licensee of
all right, title and interest in the XOMA Patent Rights; (ii) XOMA has the legal
right, authority and power to enter into this Agreement; (iii) this Agreement
shall constitute a valid and binding obligation of XOMA enforceable in
accordance with its terms; and (iv) the performance of obligations under
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this Agreement by XOMA shall not result in a breach of any agreements, contracts
or other arrangements to which it is a party.
(b) DIVERSA represents and warrants to XOMA that: (i) it is the sole and
exclusive owner or exclusive licensee of all right, title and interest in the
DIVERSA Patent Rights, (ii) DIVERSA has the legal right, authority and power to
enter into this Agreement; (iii) this Agreement shall constitute a valid and
binding obligation of DIVERSA enforceable in accordance with its terms; and (iv)
the performance of obligations under this Agreement by DIVERSA shall not result
in a breach of any agreements, contracts or other arrangements to which it is a
party.
7.2 Disclaimer. Nothing in this Agreement is or shall be construed as:
(a) A warranty or representation by XOMA or DIVERSA as to the validity
or scope of any claim or patent within the XOMA Patent Rights or the
DIVERSA Patent Rights, as the case may be;
(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 XOMA Patent Rights or the DIVERSA
Patent Rights;
(d) An obligation to maintain any patent or to continue to prosecute
any patent application included within the XOMA Patent Rights or the
DIVERSA Patent Rights in any country; or
(e) Granting by implication, estoppel, or otherwise any licenses or
rights under patents or other rights of XOMA, DIVERSA or Third Parties,
regardless of whether such patents or other rights are dominant or
subordinate to any patent within the XOMA Patent Rights or the DIVERSA
Patent Rights, as the case may be.
7.3 No Other Warranties. EXCEPT AS OTHERWISE SET FORTH IN SECTION 6.1
ABOVE, NEITHER PARTY HERETO MAKES ANY WARRANTIES WITH RESPECT TO ANY OF THE
PATENT RIGHTS, MATERIALS OR KNOW-HOW LICENSED HEREUNDER, EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY
SPECIFICALLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, OF
FITNESS FOR A PARTICULAR PURPOSE, OF VALIDITY OF SUCH PATENT RIGHTS, MATERIALS
OR KNOW-HOW, OR OF NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF ANY
THIRD PARTY.
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ARTICLE 8
INDEMNIFICATION
8.1 Indemnification. (a) DIVERSA agrees to indemnify, defend and hold XOMA
and its directors, officers, employees and agents (the "XOMA Indemnified
Parties") harmless from and against any and all liabilities, losses and expenses
(including without limitation attorneys and professional fees and other costs of
litigation), resulting from any claims, demands or causes of action by any Third
Party (each, a "XOMA Liability") arising out of (i) the possession, manufacture,
use, sale or other disposition of any DIVERSA Product, any Licensed
Immunoglobulin or the provision of any service or goods relating thereto by
DIVERSA, any DIVERSA Collaborator, any Development Partner of DIVERSA, or any
customer, vendor or other representative of any thereof, whether based on breach
of warranty, negligence, product liability or otherwise, or (ii) the exercise of
any right granted to DIVERSA, any DIVERSA Collaborator or any Development
Partner of DIVERSA pursuant to this Agreement, except to the extent, in each
case, that such XOMA Liability is caused by the negligence or willful misconduct
of XOMA. For the avoidance of doubt, the obligations of this Section 8.1(a)
shall not apply to any XOMA Liability unrelated to this Agreement.
(b) XOMA agrees to indemnify, defend and hold DIVERSA and its directors,
officers, employees and agents (the "DIVERSA Indemnified Parties" and, together
with the XOMA Indemnified Parties, each an "Indemnified Party") harmless from
and against any and all liabilities, losses and expenses (including without
limitation attorneys and professional fees and other costs of litigation),
resulting from any claims, demands or causes of action by any Third Party (each,
a "DIVERSA Liability") arising out of (i) the possession, manufacture, use, sale
or other disposition of any XOMA Development Product or the provision of any
service or goods relating thereto by XOMA, any Development Partner of XOMA or
any customer, vendor or other representative of any thereof, whether based on
breach of warranty, negligence, product liability or otherwise, or (ii) the
exercise of any right granted to XOMA or any Development Partner of XOMA
pursuant to this Agreement, except to the extent, in each case, that such
DIVERSA Liability is caused by the negligence or willful misconduct of DIVERSA.
For the avoidance of doubt, the obligations of this Section 8.1(b) shall not
apply to any DIVERSA Liability unrelated to this Agreement.
8.2 Procedure. To receive the benefit of indemnification under Section 8.1,
an Indemnified Party must (i) promptly notify the other party in writing of a
claim, demand or cause of action; provided, that failure to give such notice
shall not relieve the other party of its indemnification obligations except
where, and solely to the extent that, such failure actually and materially
prejudices the rights of the other party; (ii) provide reasonable cooperation
(at the other party's expense); and (iii) tender to the other party (and its
insurer) full authority to defend or settle the claim or suit; provided that no
settlement requiring any admission by the Indemnified Party or that imposes any
obligation on the Indemnified Party shall be made without the Indemnified
Party's consent. The other party shall not have any obligation to indemnify any
Indemnified Party in connection with any settlement made without the other
party's written consent. Each Indemnified Party has the right to participate at
its own expense in the claim or suit and in selecting counsel therefor. Each
Indemnified Party shall cooperate with the other party (and its insurer), as
reasonably requested.
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ARTICLE 9
TERM AND TERMINATION
9.1 Term. Subject to Sections 9.5 and 9.6 hereof, the term of this
Agreement will commence on the Effective Date and (a) with regard to the license
and other rights granted to XOMA and any Development Partners of XOMA by DIVERSA
pursuant to Article 4, this Agreement shall remain in full force and effect
until the last to expire of the DIVERSA Patent Rights, unless earlier terminated
by DIVERSA pursuant to Section 9.2, 9.3 or 9.4; provided, however, that upon
such expiration and absent any earlier termination pursuant to Section 9.2, 9.3
or 9.4, XOMA shall have a royalty-free, fully paid up right and license to
continue to use the Project Materials as permitted by Article 4; and (b) with
regard to the license and other rights granted to DIVERSA and any DIVERSA
Collaborators or Development Partners of DIVERSA by XOMA pursuant to Article 2
and the license rights granted to DIVERSA by XOMA pursuant to Article 3, this
Agreement shall remain in full force and effect until the last to expire of the
XOMA Patent Rights or the tenth (10th) anniversary of the First Commercial Sale
of the last DIVERSA Product to be launched, whichever is later, unless earlier
terminated by XOMA pursuant to Section 9.3 or 9.4; provided, however, that, to
the extent any of the XOMA Know-How is not included in the XOMA Patent Rights,
upon such expiration and absent any earlier termination pursuant to Section 9.3
or 9.4, DIVERSA shall have a royalty-free, fully paid up right and license to
continue to use the XOMA Know-How as permitted by Article 2 .
9.2 Termination by DIVERSA. With regard to the license and other rights
granted by XOMA to DIVERSA, DIVERSA Collaborators and Development Partners of
DIVERSA pursuant to Article 2 and to DIVERSA pursuant to Article 3, this
Agreement may be terminated by DIVERSA upon ninety (90) days' prior written
notice to XOMA, effective upon receipt by XOMA of both (a) a cash payment from
DIVERSA in the amount of [*] United States Dollars (US$[*]) if the notice of
termination occurs prior to the successful completion of at least two (2) XOMA
Projects and [*] United States Dollars (US$[*]) if the notice of termination
occurs subsequent to the successful completion of at least two (2) XOMA Projects
and (b) a written acknowledgement from DIVERSA, in form and substance reasonably
satisfactory to XOMA, stating that as of the effective date of such termination
(i) DIVERSA, and to DIVERSA's best knowledge after due inquiry each DIVERSA
Collaborator and Development Partner of DIVERSA, is, and intends to continue,
conducting its business in a manner that does and will not constitute
infringement of the XOMA Patents Rights or misappropriation of the XOMA Know-How
or otherwise require any of the licenses or other rights granted to DIVERSA,
DIVERSA Collaborators and Development Partners of DIVERSA by XOMA hereunder and
(ii) DIVERSA is discontinuing its business of discovery and/or optimization of
immunoglobulins in its entirety; provided, that the acknowledgement referred to
in the foregoing clause (ii) shall not be required in the event DIVERSA makes a
cash payment to XOMA of [*] United States Dollars (US$[*]) in lieu of the
payment otherwise required by the foregoing clause (a). Any termination pursuant
to this Section 9.2 shall have the effects provided for in Section 9.5; provided
that any DIVERSA Collaborator that retains rights to a Licensed Immunoglobulin
which was discovered, isolated or characterized pursuant to any license granted
to DIVERSA under this Agreement and as to which development has been completed
shall, upon written notice to XOMA of the identity and status of the Licensed
Immunoglobulin, continue to benefit from the license grant provided for in
clause (d) of Section 2.1 so long as such DIVERSA Collaborator
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complies with all of the provisions of this Agreement (including without
limitation the royalty obligations of Section 5.5) applicable to such Licensed
Immunoglobulin.
9.3 Termination for Material Breach. With regard to (a) the license rights
granted to XOMA and any Development Partners of XOMA by DIVERSA pursuant to
Article 4, or (b) the license and other rights granted to DIVERSA and any
DIVERSA Collaborators or Development Partners of DIVERSA by XOMA pursuant to
Article 2 and the license rights granted to DIVERSA by XOMA pursuant to Article
3, this Agreement may be terminated by the non-breaching party upon any material
breach by the breaching party of any material obligation or condition of the
Agreement, in either case effective five (5) days after giving notice to the
breaching party of such termination in the case of a payment breach and sixty
(60) days after giving written notice to the breaching party of such termination
in the case of any other breach, which notice shall describe such breach in
reasonable detail. The foregoing notwithstanding, if such breach is cured or
shown to be non-existent within the aforesaid five (5) or sixty (60) day period,
the notice shall be deemed automatically withdrawn and of no effect and the
notifying party shall provide written notice to the breaching party of the
withdrawal. A termination of the breaching party's rights and licenses pursuant
to this Section 9.3 shall not effect the non-breaching party's rights and
licenses, which shall continue until otherwise terminated in accordance with
this Agreement.
9.4 Termination for Insolvency. If voluntary or involuntary proceedings by
or against either party are instituted in bankruptcy under any insolvency law,
or a receiver or custodian is appointed for either party, or proceedings are
instituted by or against either party for corporate reorganization or the
dissolution of such party, which proceedings, if involuntary, shall not have
been dismissed within sixty (60) days after the date of filing, or if either
party makes an assignment for the benefit of creditors, or substantially all of
the assets of either party are seized or attached and not released within sixty
(60) days thereafter, the other party may immediately terminate this Agreement
effective upon notice of such termination.
9.5 Effect of Termination. (a) Termination of this Agreement 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 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) Upon any termination of this Agreement, DIVERSA and XOMA shall promptly
return to the other party all Confidential Information received from the other
party (except that each party may retain one copy for its files solely for the
purpose of determining its rights and obligations hereunder).
9.6 Survival. Sections 2.6, 2.7, 2.8, 4.1, 4.2, 4.3(e), 4.3(f), 9.1, 9.2,
9.3, 9.5 and 9.6, Articles 1, 6, 7, 8 and 10 and, only as to obligations arising
prior to the date of termination, Sections 4.3(i), 4.3(j), 4.3(k), 5.4, 5.5,
5.6, 5.8, 5.9, 5.10, 5.11, 5.12 and 5.13 shall survive any ter-
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mination hereof. Without limiting the foregoing, Articles 2 and 3 of this
Agreement shall survive any termination hereof by DIVERSA, and Article 4 of this
Agreement shall survive any termination hereof by XOMA. In the event of a
termination by DIVERSA for cause, the provisions of Sections 4.1 and 4.2 shall
not survive, except as they relate to activities occurring prior to the date of
such termination.
ARTICLE 10
MISCELLANEOUS PROVISIONS
10.1 Governing Laws. This Agreement and any dispute, including without
limitation any 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 California, without reference to conflicts of laws principles.
10.2 Assignment. Neither party may transfer or assign this Agreement,
directly or indirectly, or any of its rights hereunder without the prior written
consent of the other party, other than (a) to one or more Affiliates, (b) to a
successor of XOMA Ltd. under a Change in Control of XOMA Ltd. or to a successor
of Diversa Corporation under a Change in Control of Diversa Corporation to which
Section 10.3 does not apply, or (c) to a Third Party in connection with the
transfer or sale of all or substantially all or its business relating to
antibody selection, development and production and the provision of related
services (other than with respect to such a transfer or sale by DIVERSA to any
Person listed or described in Section 10.3). Any such attempted transfer or
assignment in violation of this Section 10.2 shall be void; provided, that in
the event of a permitted Change in Control, the original party's (or its
successor's) obligations hereunder shall continue. This Agreement shall be
binding upon and inure to the benefit of the parties and their permitted
successors and assigns.
10.3 Certain Changes in Control. Notwithstanding any other provision of
this Agreement to the contrary, the license and other rights granted pursuant to
Articles 2 and 3 shall automatically terminate, without further action by the
parties, in the event of (a) a transaction or series of related transactions in
which [*] is a party and which results in a Change of Control of DIVERSA, or (b)
a transaction or series of related transactions in which DIVERSA is a party and
which results in a Change in Control of a person or entity described in clause
(a) above.
10.4 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.
10.5 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.
10.6 Notices. All notices, requests and other communications hereunder
shall be in writing and shall be delivered or sent in each case to the
respective address specified below, or such other address as may be specified in
writing to the other party hereto, and shall be effective on receipt:
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DIVERSA: Diversa Corporation
0000 Xxxxxxxxx Xxxxx
Xxx Xxxxx, XX 00000-0000
Attn: Intellectual Property Department
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, Xxx Xxxx 00000
Attn: Xxxxxxxx X. Xxxxxxxx
10.7 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 DIVERSA as partners or joint venturers
with respect to this Agreement. Except as expressly provided herein, 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.
10.8 Compliance with Laws. In exercising their rights under this license,
the parties shall 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.
10.9 Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by one party to the other are, for all purposes of Section 365(n) of
Title XI of the United States Code ("Title XI"), licenses of rights to
"intellectual property" as defined in Title XI. During the term of this
Agreement each party shall create and maintain current copies to the extent
practicable of all such intellectual property. If a bankruptcy proceeding is
commenced by or against one party under Title XI, the other party shall be
entitled to a copy of any and all such intellectual property and all embodiments
of such intellectual property, and the same, if not in the possession of such
other party, shall be promptly delivered to it (a) upon such party's written
request following the commencement of such bankruptcy proceeding, unless the
party subject to such bankruptcy proceeding, or its trustee or receiver, elects
within thirty (30) days to continue to perform all of its obligations under this
Agreement, or (b) if not delivered as provided under clause (a) above, upon such
other party's request following the rejection of this Agreement by or on behalf
of the party subject to such bankruptcy proceeding. If a party has taken
possession of all applicable embodiments of the intellectual property of the
other party pursuant to this Section 10.9 and the trustee in bankruptcy of the
other party does not reject this Agreement, the party in possession of such
intellectual property shall return such embodiments upon request. If a party
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seeks or involuntarily is placed under Title XI and the trustee rejects this
Agreement as contemplated under 11 U.S.C. 365(n)(1), the other party hereby
elects, pursuant to Section 365(n) of Title XI, to retain all rights granted to
it under this Agreement to the extent permitted by law.
10.10 Use of Name. Neither party shall use the name or trademarks of the
other party, except to the extent that a party is permitted to use the
Confidential Information of the other party pursuant to Article 6, without the
prior written consent of such other party.
10.11 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.
10.12 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.
10.13 Arbitration. (a) Solely with respect to any dispute between the
parties to this Agreement (other than any dispute which arises out of or relates
to infringement, validity and/or enforceability of the XOMA Patent Rights or the
DIVERSA Patent Rights) upon ten (10) days written notice, any party involved in
the dispute may initiate arbitration by giving notice to that effect to the
other party or parties involved in the dispute and by filing the notice with the
American Arbitration Association or its successor organization ("AAA") in
accordance with its Commercial Arbitration Rules. Such dispute shall then be
settled by arbitration in California, in accordance with the Commercial
Arbitration Rules of the AAA or other rules agreed to by the parties involved in
the dispute, by a panel of three neutral arbitrators, who shall be selected by
the parties involved in the dispute using the procedures for arbitrator
selection of the AAA.
(b) The panel shall render its decision and award, including a statement of
reasons upon which such award is based, within thirty (30) days after the
arbitration hearing. The decision of the panel shall be determined by majority
vote among the arbitrators, shall be in writing and shall be binding upon the
parties involved in the dispute, final and non-appealable. Judgment upon the
award rendered by the panel may be entered in any court having jurisdiction
thereof in accordance with Section 10.14(a).
(c) All expenses of any arbitration pursuant to this Section 10.13,
including fees and expenses of the parties' attorneys, fees and expenses of the
arbitrators, and fees and expenses of any witness or the cost of any proof
produced at the request of the arbitrators, shall be paid by the non-prevailing
party.
10.14 Venue; Jurisdiction. (a) Any action or proceeding brought by either
party seeking to enforce any provision of, or based on any right arising out of,
this Agreement must be brought against any of the parties in the courts of the
State of California. Each party (i) hereby irrevocably submits to the
jurisdiction of the state courts of the State of California and to the
jurisdiction of any United States District Court in the State of California, for
the purpose of any suit, action, or other proceeding arising out of or based
upon this Agreement or the subject matter
-31-
hereof brought by any party or its successors or assigns, (ii) hereby waives,
and agrees not to assert, by way of motion, as a defense, or otherwise, in any
such suit, action, or proceeding, any claim that it is not subject personally to
the jurisdiction of the above-named courts, that its property is exempt or
immune from attachment or execution, that the suit, action or proceeding is
brought in an inconvenient forum, that the venue of the suit, action, or
proceeding is improper or that this Agreement or the subject matter hereof may
not be enforced in or by such court, and (iii) hereby waives and agrees not to
seek any review by any court of any other jurisdiction that may be called upon
to grant an enforcement of the judgment of any such California state or federal
court.
(b) Process in any action or proceeding seeking to enforce any provision
of, or based on any right arising out of, this Agreement may be served on any
party anywhere in the world. Each party consents to service of process by
registered mail at the address to which notices are to be given pursuant to
Section 10.6. Nothing herein shall affect the right of a party to serve process
in any other manner permitted by applicable law. Each party further agrees that
final judgment against it in any such action or proceeding arising out of or
relating to this Agreement shall be conclusive and may be enforced in any other
jurisdiction within or outside the United States of America by suit on the
judgment, a certified or exemplified copy of which shall be conclusive evidence
of the fact and of the amount of its liability.
(c) Each party agrees that it shall not, and that it shall instruct those
in its control not to, take any action to frustrate or prevent the enforcement
of any writ, decree, final judgment, award (arbitral or otherwise) or order
entered against it with respect to this Agreement, the XOMA Patent Rights or the
DIVERSA Patent Rights and shall agree to be bound thereby as if issued or
executed by a competent judicial tribunal having personal jurisdiction situated
in its country of residence or domicile.
10.15 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
-32-
IN WITNESS WHEREOF, XOMA and DIVERSA have executed this Agreement in
duplicate originals by duly authorized officers.
DIVERSA CORPORATION XOMA IRELAND LIMITED
By: ________________________________ By: ___________________________
Xxxxxxx Xxxxxxxx Xxxx Xxxx, Director
V.P., Intellectual Property duly authorized for and
on behalf of XOMA Ireland
Limited in the presence
of:
_________________________________
SCHEDULE 1.13(a)
DIVERSA Patent Rights -- Patents, Etc.
[*]
SCHEDULE 1.13(b)
DIVERSA Patent Rights -- Third Party Licenses
None.
SCHEDULE 1.34
XOMA Patent Rights
Title: Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use
Inventors: Robinson, Liu, Horwitz, Wall, Better
1) Based on PCT/US86/02269, which is a continuation-in-part of U.S.
Serial No. 06/793,980 filed November 1, 1985 (abandoned).
COUNTRY SERIAL NO. PATENT NO.
------- ---------- ----------
*United States 06/793,980
Australia 65981/86 Issued 606,320
Canada 521,909 Abandoned
Denmark 3385/87 Pending
Taiwan 75105650 Issued 51922
*United States U.S. National Phase of
PCT/US86/02269
2) Based on PCT/US88/02514, which corresponds to U.S. Serial No.
07/077,528, which is a continuation-in-part of PCT/US86/02269 (abandoned),
which is a continuation-in-part of U.S. Serial No. 06/793,980 (abandoned).
COUNTRY SERIAL NO. PATENT NO.
------- ---------- ----------
Australia 23244/88 Issued 632,462
Austria EP 88907510.7 Granted EP/0371998
Belgium EP 88907510.7 Granted EP/0371998
Canada 572,398 Granted 1,341,235
Xxxxxxx 000/00 Pending
Europe EP 88907510.7 Granted EP/0371998
Europe EP 95119798.7 Granted EP/0731167
France EP 88907510.7 Granted EP/0371998
Germany EP 88907510.7 Granted EP/0371998
Italy EP 88907510.7 Granted EP/0000000
Japan 506481/88 Granted 2991720
Luxembourg EP 88907510.7 Granted EP/0371998
Netherlands EP 88907510.7 Granted EP/0371998
Sweden EP 88907510.7 Granted EP/0371998
Switzerland/
Liechtenstein EP 88907510.7 Granted EP/0371998
United Kingdom EP 88907510.7 Granted EP/0371998
Europe EP 93100041.8 Granted EP/0550400
Austria EP 93100041.8 Granted EP/0550400
Belgium EP 93100041.8 Granted EP/0550400
France EP 93100041.8 Granted EP/0550400
Germany EP 93100041.8 Granted EP/0550400
Italy EP 93100041.8 Granted EP/0550400
-33-
COUNTRY SERIAL NO. PATENT NO.
------- ---------- ----------
Luxembourg EP 93100041.8 Granted EP/0550400
Netherlands EP 93100041.8 Granted EP/0550400
Sweden EP 93100041.8 Granted EP/0550400
Switzerland/
Liechtenstein EP 93100041.8 Granted EP/0550400
United Kingdom EP 93100041.8 Granted EP/0550400
*United States 07/077,528
3) Based on U.S. Serial No. 07/501,092 filed March 29, 1990, which is
a continuation-in-part of U.S. Serial No. 07/077,528 (Modular Assembly of
Antibody Genes, Antibodies Prepared Thereby and Use; Robinson, Liu,
Horwitz, Wall, Better) and of U.S. Serial No. 07/142,039 (Novel Plasmid
Vector with Pectate Lyase Signal Sequence; Lei, Xxxxxx).
COUNTRY SERIAL NO. PATENT NO.
------- ---------- ----------
*United States 07/501,092
*United States 07/987,555
*United States 07/870,404
*United States 08/020,671
United States 08/235,225 5,618,920
United States 08/299,085 5,595,898
United States 08/472,691 6,204,023
United States 08/467,140 5,698,435
United States 08/450,731 5,693,493
United States 08/466,203 5,698,417
Title: Novel Plasmid Vector with Pectate Lyase Signal Sequence
Inventors: Lei, Xxxxxx
Based on U.S. Application No. 07/142,039 filed January 11, 1988 and
PCT/US89/00077
COUNTRY SERIAL NO. PATENT NO.
------- ---------- ----------
Australia 29377/89 Granted 627,443
Canada 587,885 Granted 1,338,807
Europe EP 89901763.6 Granted EP/0396612
Austria EP 89901763.6 Granted EP/0396612
Belgium EP 89901763.6 Granted EP/0396612
France EP 89901763.6 Granted EP/0396612
Germany EP 89901783.6 Granted EP/0396612
Italy EP 89901763.6 Granted EP/0396612
Luxembourg EP 89901763.6 Granted EP/0396612
Netherlands EP 89901763.6 Granted EP/0396612
Sweden EP 89901763.6 Granted EP/0396612
Switzerland/Liechtenstein EP 89901763.6 Granted EP/0396612
United Kingdom EP 69901763.6 Granted EP/0396612
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COUNTRY SERIAL NO. PATENT NO.
------- ---------- ----------
Japan 501661/89 Granted 2,980,626
*United States 07/142,039
__________________
* Cases abandoned in favor of a continuing application.
SCHEDULE 2.2
Transfer of XOMA Materials
[*]
SCHEDULE 2.5
Form of Notice
XOMA owns a number of patents covering various aspects of bacterial antibody
expression and phage display.
XOMA has licensed these patents on a non-exclusive basis to DIVERSA.
Under the license agreement with XOMA:
DIVERSA cannot provide evolution services or transfer related products or
information to you without first showing you a redacted copy of its
license from XOMA and this notice.
If you and DIVERSA enter into a written agreement by which you become a
"DIVERSA Collaborator," then you will be permitted to use DIVERSA
evolution services and related products and information to research,
develop and commercialize antibody products.
Collaborators do not, however, have the right to produce commercial
quantities of such antibodies using XOMA's patented technology.
Rather, collaborators only have the right to make research and
development quantities of antibodies using the XOMA patent rights.
Thereafter, unless the collaborator obtains a commercial production
license from XOMA (which may be available), the collaborator must
produce commercial quantities of antibodies using a method that does
not infringe XOMA patent rights.
Therefore, if you and DIVERSA enter into a written agreement, that
agreement must contain certain provisions specified in the license
agreement with XOMA, including:
o Terms pursuant to which you, as the recipient of any transferred materials,
would agree to abide by each of the limitations, restrictions and other
obligations provided for by the license agreement with XOMA, including
without limitation the restrictions on use of such transferred materials
for purposes other than research and development.
o A covenant not to use transferred materials for any purpose other than for
research and development purposes otherwise authorized by the license
agreement with XOMA.
o A provision that the "first sale" doctrine does not apply to any
disposition of transferred materials.
o An agreement by you to further dispose of transferred materials only to a
third party who otherwise meets the definition of a "DIVERSA Collaborator"
set forth in the license agreement with XOMA and who executes a written
agreement in which it undertakes all of the obligations applied to the
transferring party.
SCHEDULE 2.8
Third Parties and Activities
(i) Third Parties Released From Past Infringement Pursuant to Section 2.8:
[*]
(ii) Activities as to Which the Above Third Parties are Released:
[*]
For the sake of clarity, if any Third Party identified on this Schedule 2.8 as a
party on the Effective Date to an agreement set forth hereon has also
collaborated with any other entity or person engaged in the Commercial Antibody
Phage Display Business or Commercial Antibody Evolution Business, including but
not limited to those entities referred to in Section 2.8 of the agreement to
which this Schedule 2.8 is attached, then the release herein shall extend solely
to the activities of such Third Party that are carried out pursuant to and in
accordance with the agreement set forth on this Schedule 2.8 to which it is a
party as in effect on the Effective Date.
SCHEDULE 4.3(a)
[*]
SCHEDULE 6.4
Press Release
XOMA AND DIVERSA SIGN LICENSE AND ANTIBODY DEVELOPMENT AGREEMENT
********************************************************************************
BERKELEY, CA and SAN DIEGO, CA - January 6, 2004 - XOMA Ltd. (Nasdaq: XOMA) and
Diversa Corporation (Nasdaq: DVSA) today announced that they have entered into a
licensing and product development agreement. Under the terms of the agreement,
Diversa will receive a license to use XOMA's antibody expression technology for
developing antibody products independently and with collaborators, and an option
to a license for the production of antibodies under the XOMA patents. XOMA will
receive a license fee and potential future milestone and royalty payments. Under
the terms of the development portion of the agreement, XOMA and Diversa will
combine their respective capabilities to discover and develop antibodies for
autoimmune-related diseases. Diversa will receive research funding and is
entitled to receive milestones and royalties on any drugs developed under the
agreement.
"We are excited to announce this relationship with Diversa," said Xxxx X.
Xxxxxxxx, XOMA's chairman, president and chief executive officer. "Their ability
to generate and optimize antibodies against challenging targets and to improve
antibody performance is a valuable capability. XOMA's bacterial cell expression
technology, in turn, is a valuable asset for Diversa's antibody discovery
program."
"We are pleased by this new agreement with XOMA, a company that has demonstrated
its ability to successfully develop protein therapeutics and bring them to
market," stated Xxx X. Short, Ph.D., President and Chief Executive Officer of
Diversa Corporation. "This advances our pharmaceutical strategy for establishing
drug development partnerships in areas other than anti-infectives, which we are
focused on developing internally."
- More -
About Diversa's Antibody Building System (ABS)
Diversa's Antibody Building System is designed to deliver superior antibodies by
generating new antibodies against challenging targets and improving suboptimal
antibodies. To create new antibodies, Diversa utilizes its synthetic antibody
library of over a billion clones as a basis for generating antibodies against
both traditional and refractory targets, as well as for creating agonistic
antibodies. In addition to this de novo antibody generation, Diversa's Medicinal
Evolution capabilities can be applied to engineer existing antibodies to meet
specific criteria including stability, solubility, and affinity.
About XOMA's Cell Expression System
XOMA's Bacterial Cell Expression System is a flexible package of complementary
technologies, materials, methods and know-how that provides many of today's
leading biotechnology companies and XOMA collaborators with the ability to
produce antibodies in bacteria for use as therapeutics and medical diagnostics,
as well as for drug discovery, lead optimization and research purposes. The
value of XOMA's Bacterial Cell Expression System's ability to produce a wide
variety of immunoglobulins is well recognized, as evidenced by the fact that
more than 25 companies currently hold a license for expression of molecules in
bacteria.
About Diversa
Diversa Corporation is a leader in applying proprietary genomic technologies for
the rapid discovery and optimization of novel products from genes and gene
pathways. Diversa is directing its integrated portfolio of technologies to the
discovery, evolution, and production of commercially valuable molecules with
pharmaceutical applications, such as optimized monoclonal antibodies and orally
active drugs, as well as enzymes and small molecules with agricultural,
chemical, and industrial applications. In addition, Diversa has formed alliances
and joint ventures with market leaders, such as BASF, The Dow Chemical Company,
DuPont Bio-Based Materials, Givaudan Flavors Corporation, GlaxoSmithKline plc,
Invitrogen Corporation, and affiliates of Syngenta AG. Additional information is
available at Diversa's website: xxx.xxxxxxx.xxx.
About XOMA
XOMA develops and manufactures antibody and other protein-based
biopharmaceuticals for disease targets that include cancer, immunological and
inflammatory disorders, and infectious diseases. XOMA's programs include
collaborations with Genentech, Inc. on the RAPTIVA(TM) antibody for psoriasis
(marketed), psoriatic arthritis (Phase II) and other indications; with
Millennium Pharmaceuticals, Inc. on a recombinant protein, MLN 2222, for
reducing the incidence of post-operative events in coronary artery bypass graft
surgery patients employing cardiopulmonary bypass (Phase I); and with Alexion
Pharmaceuticals, Inc. on a c-MPL agonist antibody to treat chemotherapy-induced
thrombocytopenia.
- More -
Bactericidal/permeability-increasing protein (BPI)-derived programs include
NEUPREX(R) in a Phase I/II study to limit complications following pediatric
cardiopulmonary bypass surgery, and XMP.629, a topical formulation of a
BPI-derived compound for acne (Phase I). Other development programs focus on
antibodies and other compounds developed by XOMA for the treatment of cancer and
retinopathies. For more information about XOMA's pipeline and activities, please
visit XOMA's website at xxxx://xxx.xxxx.xxx/.
Diversa Forward-Looking Statements
Statements in this press release that are not strictly historical are
"forward-looking" and involve a high degree of risk and uncertainty. These
include statements related to possible products developed under the agreement
with XOMA or independently or with collaborators, the receipt of additional
payments for products developed under the agreement, the establishment of drug
de-
-2-
velopment partnerships, and the ability of Diversa's Antibody Building System
to generate new antibodies and to improve antibodies, all of which are
prospective. Such statements are only predictions, and the actual events or
results may differ materially from those projected in such forward-looking
statements. Factors that could cause or contribute to differences include, but
are not limited to, risks involved with Diversa's new and uncertain
technologies, risks associated with Diversa's dependence on patents and
proprietary rights, risks associated with Diversa's protection and enforcement
of its patents and proprietary rights, risks associated with XOMA's technologies
and intellectual property, Diversa's dependence on existing collaborations,
Diversa's ability to maintain the agreement with XOMA, the ability of Diversa to
commercialize products using Diversa's technologies and/or the technologies
licensed by Diversa under the agreement with XOMA, the development or
availability of competitive products or technologies, and the future ability of
Diversa to enter into and/or maintain collaboration and joint venture
agreements,. Certain of these factors and others are more fully described in
Diversa's filings with the Securities and Exchange Commission, including, but
not limited to, Diversa's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2003. These forward-looking statements speak only as of the date
hereof. Diversa expressly disclaims any intent or obligation to update these
forward-looking statements.
Re: XOMA
Certain statements contained herein related to product development, licensing or
collaborative arrangements or that otherwise relate to future periods are
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These
statements are based on assumptions that may not prove accurate. Actual results
could differ materially from those anticipated due to certain risks inherent in
the biotechnology industry and for companies engaged in the development of new
products in a regulated market. These and other risks, including those related
to the results of discovery research and pre-clinical testing, the timing or
results of pending and future clinical trials (including the design and progress
of clinical trials; safety and efficacy of the products being tested; action,
inaction or delay by the FDA, European or other regulators or their advisory
bodies; and analysis or interpretation by, or submission to, these entities or
others of scientific data), changes in the status of the existing collaborative
relationships, the ability of collaborators and other partners to meet their
obligations, market demand for products, scale up and marketing capabilities,
competition, international operations, share price volatility, XOMA's financing
needs and opportunities, uncertainties regarding the status of biotechnology
patents, uncertainties as to the cost of protecting intellectual property and
risks associated with XOMA's status as a Bermuda company, are described in more
detail in the Company's most recent annual report on Form 10-K and in other SEC
filings.
###
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