1346ictz Exhibit 10.56
Eo419
23 February 98
LICENSE
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AND
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COLLABORATION AGREEMENT
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THIS LICENSE AND COLLABORATION AGREEMENT ("Agreement") is entered into
as of February 27, 1998, between EPIMMUNE INC. ("Epimmune"), and X.X. XXXXXX &
CO. ("Xxxxxx") (individually a "Party" or collectively the "Parties").
WHEREAS, Epimmune is the owner of certain valuable know-how and patent
rights relating to certain technology platforms for the treatment and prevention
of cancer; and
WHEREAS, Xxxxxx wishes to obtain licenses to make, have made, use and
sell in vivo and ex vivo immunotherapeutic and prophylactic products using such
technology and to collaborate with Epimmune in the research and identification
of such products for the treatment and/or prevention of cancer; and
WHEREAS, Epimmune is willing to grant such licenses to Xxxxxx and to
collaborate with Xxxxxx to develop such pharmaceutical products, subject to the
terms and conditions set forth in this Agreement.
NOW, THEREFORE, the Parties agree as follows:
ARTICLE 1. DEFINITIONS.
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1.1 "ACT" means, as applicable, either (a) the United States Food, Drug and
Cosmetics Act and applicable regulations thereunder, as amended from
time to time, or (b) the comparable laws, rules and regulations
governing the registration, approval and sale of pharmaceutical drugs
and devices in countries outside of the United States, as amended from
time to time.
1.2 "AFFILIATE(S)" means any entity which directly or indirectly controls,
is controlled by or is under common control with a Party. For purposes
of this definition, "control" shall mean the power to direct or cause
the direction of the management and policies of an entity, whether
through ownership of voting securities, by contract or otherwise.
1.3 "COLLABORATION" means the collaborative research activities of the
Parties under this Agreement pursuant to the Research Plan during the
Collaboration Term and the oversight by the JMC of the conduct of the
Initial Development by the JPT.
1.4 "COLLABORATION TERM" is defined in Section 15.1.1.
1.5 "CONTROL" means possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any
agreement or arrangement with any Third Party.
1.6 "COST OF GOODS" means the cost of a Product or Product Component, as
applicable, in bulk or finished form (including samples) calculated in
accordance with GAAP. Cost of Goods shall include: (a) the cost of
manufacture for a Product or Product Component, as applicable,
manufactured by Xxxxxx or the amount paid for Product or Product
Component manufactured by a Third Party; (b) the net cost or credit of
any value-added taxes or duties actually paid or utilized in respect of
the Product or Product Component; (c) the cost of freight, insurance
and other transportation charges for the Product or Product Component
to the extent not invoiced to Third Parties and (d) the cost of any
royalty payments paid to Epimmune or Third Parties necessary for the
manufacture, use or sale of [...***....] For purposes of this
definition, "cost of manufacture" means the fully allocated cost of
manufacturing a Product or Product Component, as applicable,
(calculated in accordance with GAAP applied on a basis consistent with
Xxxxxx'x past practices), excluding start up expenses and including the
direct and indirect cost of any raw materials, packaging materials and
labor (including benefits) utilized in such manufacturing (including
formulating, filling, finishing, labeling and packaging, as applicable)
plus factory overhead (fixed and variable) allocated to such Product or
Product Component.
1.7 "CYTOKINES" means a growth factor developed and/or owned by Xxxxxx or
developed and/or owned by a Third Party.
1.8 "DEVELOPMENT" means all pre-clinical and clinical development
activities with respect to a Product following the Product Alert,
through and including obtaining Regulatory Approval.
1.9 "DEVELOPMENT BUDGET" means, with respect to each Product developed
hereunder, the budget for the proposed costs to develop such Product
under the Development Plan.
1.10 "DEVELOPMENT PLAN" means, with respect to each Product developed
hereunder, the plan for the Development of such Product from the first
Development activity to its Launch Date.
1.11 "EFFECTIVE DATE" means the later of the date on which this Agreement is
executed by both Parties or the first business day following the day on
which all required waiting periods under the Xxxx-Xxxxx-Xxxxxx
Antitrust Improvements act of 1976, as amended, have expired or been
terminated.
CONFIDENTIAL TREATMENT REQUESTED
1.12 "EPIMMUNE INITIAL TECHNOLOGY" means any Patent Rights and Know-How
Controlled by Epimmune relating to the development, manufacture, use,
marketing, sale and/or importation of Products in the Field which exist
as of the Effective Date.
1.13 "EPIMMUNE PROJECT TECHNOLOGY" means any Patent Rights and Know-How
invented solely by Epimmune during the course of performing work under
the Research Plan and/or Development Plan during the Collaboration
Term.
1.14 "EPITOPE" means the portion of an antigen that makes contact with a
particular antibody or T cell receptor.
1.15 "FIELD" means in vivo and ex vivo immunotherapeutic and prophylactic
therapies for the treatment and prevention of cancer.
1.16 "GAAP" means United States generally accepted accounting principles.
1.17 "IMPROVEMENT" means any invention or discovery, patentable or not,
relating to the use, synthesis or manufacture of Products within the
Field, that is dominated by the Epimmune Initial Technology, the
Epimmune Project Technology or the Joint Technology and which comes
under the Control of Epimmune.
1.18 "INITIAL DEVELOPMENT" means early stage development activities
following Research up to the issuance of a Product Alert.
1.19 "INTELLECTUAL PROPERTY RIGHTS" means all Patent Rights, trademarks,
copyrights and/or Know-How relating to the development, manufacture,
use, marketing, or sale and/or importation of the Products in the Field
which are Controlled by either Party as of the Effective Date or comes
under the Control of either Party during the term of this Agreement or
Controlled jointly by the Parties.
1.20 "JMC" means the Joint Management Committee described in Section 3.2.
1.21 "JPT" means the Joint Project Team described in Section 3.3.
1.22 "JOINT TECHNOLOGY" means any Patent Rights and Know-How invented
jointly by Epimmune and Xxxxxx during the course of performing work
under the Research Plan and/or Development Plan during the
Collaboration Term.
1.23 "KEY MARKET(S)" means France, Germany, Italy, Japan, the United Kingdom
and the United States.
1.24 "KNOW-HOW" means all proprietary, confidential technical information
and data relating to Products, including, without limitation all data
relating to synthesis, formulation, manufacture, analytical methods,
clinical trials, pharmacology and toxicology.
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1.25 "LAUNCH DATE" means, with respect to each Product, the date of the
first sale of a Product to a Third Party by Xxxxxx, its Affiliates or
sublicensees through customary commercial channels of distribution.
1.26 "NET SALES" means:
(a) with respect to any Product, the gross amount invoiced on
sales of a Product by a Party and/or its Affiliates and/or
sublicensees, as applicable, to Third Parties, less the following
items: (i) trade, cash and quantity and promotional discounts actually
allowed and taken; (ii) excise, sales taxes or other taxes imposed upon
and paid with respect to such sales (excluding national, state or local
taxes based on income) as adjusted for rebates or refunds; (iii)
freight, insurance and other transportation charges invoiced to Third
Parties; (iv) amounts repaid or credited by reason of rejections,
defects, recalls or returns; and (v) rebates (including pursuant to
Medicaid or other similar governmental rebate, discount or chargeback
programs).
(b) with respect to the [...***...] of any Product Type 2, the
amount equal to the net amount invoiced on sales of a Product Type 2 by
a Party and/or its Affiliates and/or sublicensees (determined in the
manner described in (a)) multiplied by the [...***...] (as defined
below) attributable to such Product Type 2; and
(c) with respect to the [...***...] of any Product Type 2, the
amount equal to the net amount invoiced on sales of a Product Type 2 by
a Party and/or its Affiliates and/or sublicensees (determined in the
manner described in (a)) multiplied by the [...***...] (as defined
below) attributable to such Product Type 2.
The [...***...] shall mean a fraction, the numerator of which is the
fair market value of the [...***...] included in the Product Type 2 and
the denominator of which is the fair market value of all components
included in the Product Type 2 (e.g., [...***...] and/or other
ingredients). The [...***...] shall mean a fraction, the numerator of
which is the fair market value of the [...***...] included in the
Product Type 2 and the denominator of which is the fair market value of
all components included in the Product Type 2 (e.g., [...***...] and/or
any other ingredients). In the event that no market price is available
for the [...***...], the fair market value shall be determined in good
faith by the Parties, no later than the Launch Date for such
-4- CONFIDENTIAL TREATMENT REQUESTED
Product Type 2, taking into consideration, but not limited to, such
factors as a cost/benefit analysis of each Product component and
Product as a whole, drug profile, ease of use by patient and/or service
provider, competition and other relevant market factors. In the event
that the Parties disagree regarding the fair market value, the Parties
shall resolve such dispute in accordance with Section 19.12 hereof.
1.27 "PADRE" means PAN DR Reactive Epitopes, as described in the Patent
Rights included in the Epimmune Initial Technology.
1.28 "PATENT RIGHTS" means all claims contained in patents or patent
applications and all divisions, continuations, continuations-in-part,
reissues, extensions, renewals, supplementary protection certificates
and foreign counterparts thereof, existing as of the Effective Date or
filed or issuing during the Collaboration Term. The Patent Rights
included in the Epimmune Initial Technology are set forth in Exhibit A.
The Patent Rights included in the Xxxxxx Initial Technology are set
forth in Exhibit B.
1.29 "PHASE I", "PHASE II", "PHASE III" AND "PHASE IV" means the phases of
clinical development of pharmaceutical products and/or devices as
defined in the Act.
1.30 "PRIOR AGREEMENTS" means the Confidentiality Agreement between the
Parties dated December 3, 1996 and the Letter Agreement between the
Parties dated September 5, 1997, as amended December 19, 1997.
1.31 "PRODUCT ALERT" is defined in Section 2.3.
1.32 "PRODUCT(S)" means any pharmaceutical product which is covered by at
least one claim of the Patent Rights contained in Epimmune Initial
Technology, Epimmune Project Technology and/or Joint Technology in any
country.
1.33 "PRODUCT COMPONENT" means with respect to Xxxxxx, [...***...] and, with
respect to Epimmune, [...***...] or other active component which is
covered by at least one claim of the Patent Rights contained in
Epimmune Initial Technology, Epimmune Project Technology and/or Joint
Technology.
1.34 "PRODUCT TYPE 1" means a Product which contains an [...***...] alone
and is not packaged in combination with a [...***...] nor sold at a
single price in combination with a [...***....]
1.35 "PRODUCT TYPE 2" means a Product which contains [...***...] Component
and is packaged in combination with one or more [...***...] or sold at
a single price in combination with a [...***....]
-5- CONFIDENTIAL TREATMENT REQUESTED
1.36 "PROJECT MANAGER" is defined in subsection 3.4.
1.37 "REGULATORY APPROVAL" means all authorizations by the relevant
competent authorities required for marketing, promoting, pricing,
reimbursing and selling of a Product in a given country of the
Territory.
1.38 "REGULATORY AUTHORITY" means the United States Food and Drug
Administration and/or such other similar and appropriate government
regulatory authority or agency outside the United States, the approval
of which is required for marketing, promoting, pricing, reimbursing and
selling Products in the Territory.
1.39 "RESEARCH" means all discovery phase activities which precede
pre-clinical and clinical development phases.
1.40 "RESEARCH BUDGET" is defined in Section 2.2.1.
1.41 "RESEARCH PLAN" is defined in Section 2.2.1.
1.42 "XXXXXX INITIAL TECHNOLOGY" means any Patent Rights and Know-How
Controlled by Xxxxxx and applicable to the Field which exist as of the
Effective Date.
1.43 "XXXXXX PROJECT TECHNOLOGY" means any Patent Rights and Know-How
invented solely by Xxxxxx during the course of performing work under
the Research Plan and/or Development Plan during the Collaboration
Term.
1.44 "TERRITORY" means all the countries of the world.
1.45 "THIRD PARTY" means any person or entity other than Epimmune, Xxxxxx or
their respective Affiliates.
ARTICLE 2. RESEARCH COLLABORATION AND DEVELOPMENT.
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2.1 SCOPE. The Parties shall collaborate to research and develop Products
for use in the Field, making use of each Party's special expertise in
the following manner:
(a) The Research and Initial Development phases will be conducted
jointly by the Parties pursuant to a mutually agreed Research
Plan, through one or more joint project teams ("JPTs") as
described in Section 3.3. The Research Plan is more particularly
described in Section 2.2.
(b) The Development phase will be conducted by a Xxxxxx Project Team
pursuant to the applicable Development Plan with support from
Epimmune pursuant to the Research Plan. The Development Plan is
more particularly described in Section 2.4.
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2.2 RESEARCH PLAN AND BUDGET.
2.2.1 A preliminary research plan and research budget are attached
hereto as Exhibit C and Exhibit D, respectively. Epimmune
will prepare, in consultation with Xxxxxx, and provide to
the JMC within three (3) months following the Effective Date
a four (4) year finalized research plan covering the
calendar years 1998, 1999, 2000 and 2001 (as updated in
accordance with Section 2.2.2, the "Research Plan") and a
finalized budget for proposed Research costs (the "Research
Budget") during the Collaboration Term. The Research Plan
shall specify in detail all Research activities and
priorities, time frames for completion of activities, which
Party or Third Party is to be responsible for each activity,
and any other items reasonably required by the Parties.
Epimmune's financial obligation beginning [...***...] and
continuing through the [...***...] shall be [...***....]
which amount shall be expended in accordance with the
Research Plan and Research Budget. Such amount shall not be
increased without Epimmune's approval and shall not be
decreased without Xxxxxx'x approval.
2.2.2 The Research Plan shall be updated annually by the JPT(s),
and reviewed and approved by the JMC, during the
Collaboration Term. Not later than September 1st of each
year of the Collaboration Term (other than the last year of
the Collaboration Term unless the Collaboration Term is
extended), the JPT will prepare, in consultation with the
JMC, and provide to Xxxxxx a rolling, three (3) year
research plan (the "Rolling Research Plan") which updates
the Research Plan and details Epimmune's research activities
planned and/or required to support Xxxxxx'x on-going
strategic, development and commercial objectives in
connection with the development of Products as set forth in
the Development Plan or otherwise. If the Collaboration Term
is extended by mutual agreement pursuant to Section 15.1.1,
then the Rolling Research Plan agreed to by the JMC in 2001
shall serve as the Research Plan for the calendar years
2002, 2003 and 2004, unless otherwise agreed by the parties.
2.3 PRODUCT ALERT. A product alert is the formal selection of a compound
for clinical development based on criteria determined by Xxxxxx in
accordance with the procedures set forth in its "Product Lead Team
Document Outline and Approval Process" document dated February 7, 1997
("Product Alert"). Xxxxxx shall determine the criteria for each Product
Alert and advise Epimmune as soon as practicable of such criteria for
each Product to be developed hereunder and such criteria shall be
included in the Research Plan. Each JPT is responsible for the
conduct and management of the Research Plan and Initial Development
relating to each Product developed within the technology platform
applicable to such JPT until, with respect to individual potential
Products, each such potential Product enters the Product Alert stage.
Not later than the issuance of a Product Alert for each new Product
entering the Product Alert stage, a "Xxxxxx Project Team" shall be
formed for the implementation, conduct and management of the
Development activities for such potential Product. The Xxxxxx Project
Team shall be comprised of those Xxxxxx representatives responsible for
the relevant Development activities and one Epimmune representative.
-7- CONFIDENTIAL TREATMENT REQUESTED
2.4 DEVELOPMENT PLAN AND BUDGET.
2.4.1 PREPARATION AND SUBMISSION. Promptly following the
constitution of the first JPT pursuant to the terms of
Section 3.3, the JPT shall prepare and submit, not later
than three (3) months following the Effective Date, to the
JMC the Development Plan for the first Product to be
developed hereunder and the Development Budget for such
Product. Promptly following Xxxxxx'x approval of the
Development of Products under a new technology platform, a
JPT shall be formed, unless otherwise agreed by the JMC.
Within three (3) months after the formation of each such
JPT, the JPT (or, if no such JPT was formed, pursuant to the
decision of the JMC, the existing JPT(s)) shall submit to
the JMC the Development Plan and Development Budget for such
new Product. Each Development Plan and its Development
Budget shall be updated as deemed appropriate by the
applicable Xxxxxx Project Team, but in no event less
frequently than annually. Each Development Plan and its
annual update shall specify in detail all Development
activities and priorities, time frames for completion of
activities, which Party or Third Party is to be responsible
for each activity, and any other items reasonably required
by the Parties with respect to the Development of the
applicable Product, with the first twelve (12) months of
such Plan and/or updated Plan provided in detail, and with
as much detail as then available for the remaining years of
such Plan and/or updated Plan. Each Development Plan will
also include, to the extent practicable, the then-expected
profile for the Product being developed thereunder, the
desired labelling and the criteria for determining
acceptable requirements for any appropriate worldwide
applications for Regulatory Approval. In preparing each
Development Plan and Development Budget, the JPT (or Xxxxxx
Project Team, as appropriate) shall ensure that there is
adequate marketing input and shall give due consideration to
worldwide development of the Product.
2.4.2 APPROVALS. During the Collaboration Term, each Development
Plan, its annual update and changes thereto shall be subject
to the approval of the JMC as provided in subsection 3.2.2.
Following the Collaboration Term, Xxxxxx shall have the
right, in its sole discretion, to change or amend the
Development Plan; provided, however no such change or
amendment shall alter Xxxxxx'x obligations under Article 17,
except as otherwise provided in Sections 17.2.4 and 17.2.5.
Xxxxxx'x financial obligation with respect to the
Development Plan shall be set forth in the Development
Budget. The Development Budget and any changes thereto shall
be subject to the sole approval of Xxxxxx.
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2.5 XXXXXX RESPONSIBILITIES. Xxxxxx shall be responsible for conducting the
following Research and Development activities in accordance with the
requirements of the Research Plan and/or Development Plan(s):
(a) to supply [...***...] used in Research and Development of the
Products;
(b) to provide all analytics required for the Products;
(c) to provide preclinical development such as pharmacology,
toxicology, formulation, etc.;
(d) to perform stability and compatibility studies;
(e) to develop worldwide clinical, regulatory and commercialization
strategies for the Products;
(f) to prepare, submit and maintain all appropriate worldwide filings
for the initiation and conduct of clinical trials;
(g) to develop a worldwide clinical plan;
(h) to conduct, directly or via Third Parties, all clinical trials
necessary to launch Products worldwide;
(i) to prepare, submit and maintain applications for Regulatory
Approvals and manage all communications with Regulatory
Authorities; and
(j) to provide support for marketing of Products following Product
launch (e.g., Phase IV Studies).
For purposes of dispute resolution in accordance with subsection 3.3.4,
Xxxxxx is hereby designated as the Lead Party for each of the
responsibilities listed above.
2.6 EPIMMUNE RESPONSIBILITIES. Epimmune shall be responsible for conducting
the following Research activities in accordance with the requirements
of the Research Plan:
(a) to identify, test, and modify [...***...] of human tumor antigens;
(b) to conduct research to define [...***...];
(c) to conduct research to define [...***...]; and
(d) to provide necessary support of development, clinical and
marketing efforts as defined in the Development Plan.
-9- CONFIDENTIAL TREATMENT REQUESTED
For purposes of dispute resolution in accordance with subsection 3.3.4,
Epimmune is hereby designated as the Lead Party for each of the
responsibilities listed in (a), (b) and (c) above.
2.7 ON-SITE PRESENCE. Xxxxxx may have representative(s) occupy space at
Epimmune's premises on an as-needed basis in order to participate in
the Research Plan and, if necessary, Development Plan activities during
the Collaboration Term.
ARTICLE 3. MANAGEMENT.
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3.1 COMMITTEES. The Parties agree that the Collaboration activities and
relationship hereunder will be managed by the JMC and the JPT.
3.2 JOINT MANAGEMENT COMMITTEE.
3.2.1 COMPOSITION. The JMC will be composed of three (3) members
from each Party. Promptly after the Effective Date, the
Parties will appoint their respective representatives to the
JMC. The position of chairperson shall rotate between the
Parties annually. The chairperson during the first year of
the term hereof will be a Xxxxxx representative. A Party may
change any of its representatives at any time by giving
written notice to the other Party. The JMC will continue in
existence through the end of the Collaboration Term.
3.2.2 RESPONSIBILITIES. The JMC will oversee the Collaboration and
the Development Plan and manage the relationship hereunder,
including the JPT. In particular, the JMC will:
(a) oversee the JPT;
(b) review and approve the Research Plan and Initial
Development;
(c) provide recommendations relating to the conduct of the
Research Plan and Initial Development;
(d) approve the terms of any agreements for the use or
acquisition of Third Parties' enabling technology as it
relates to an Epimmune technology platform;
(e) subject to the provisions of Sections 2.4.2 and 4.2,
pre-approve any modification in the Development Budget;
(f) approve the Cytokine components, if any, to be used in
the final Products;
(g) approve any material change in the Initial Development;
(h) conduct program reviews at least twice yearly, or more
frequently as determined by the JMC;
(i) review and approve Joint Technology patent strategies
and filings based on the recommendations of the
Parties' patent counsel pursuant to Article 11; and
(j) perform such other functions as agreed in writing by the
Parties.
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3.2.3 MEETINGS AND VOTING. The JMC will meet at such times as
either Party may request, but in no event less frequently
than twice per calendar year, alternating between the
principal places of business of each Party (San Diego and
Skokie or St. Louis) and will otherwise communicate as
necessary by telephone, facsimile and video conference. The
chairperson shall appoint a secretary, who shall be
responsible for circulating minutes of the meeting within
ten (10) business days following the meeting. Each Party
recognizes the importance of the JMC in the success of the
Collaboration and will use diligent efforts to cause all its
representatives to attend all meetings. The JMC shall make
decisions by unanimous consent. Voting by proxy is
permissible. All decisions of the JMC shall be final and
non-appealable. Additional participants may be invited by
any member to attend meetings where appropriate, provided
such additional participants shall have no vote.
3.2.4 DISPUTE RESOLUTION. If any dispute arises between the
Parties as a result of any decision made or not made by the
JMC or as a result of the JMC's failure to resolve an issue
reviewed by it, then Epimmune shall make the final decision
on Research matters relating to Epitope and PADRE
technologies, for which it has responsibility under the
Research Plan, and Xxxxxx shall make the final decision on
all other matters. If either Party in good faith believes
such final decision of the other Party will have a
materially adverse effect on the outcome of the Research
Plan and/or the Development Plan, then such Party may refer
the issue to the senior executives of each Party (i.e., the
President of Epimmune and the President of Xxxxxx R&D) for
resolution. If the senior executives are unable to resolve
such issue within thirty (30) days of the date it was
referred to them, the Parties shall resolve such dispute in
accordance with Section 19.12 hereof.
3.3 JOINT PROJECT TEAM.
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3.3.1 COMPOSITION. The JPT will be composed of representatives
from each Party, including each Party's Project Manager, who
are directly involved with and responsible for Research and
Development activities. Promptly after the Effective Date,
the Parties will appoint their respective representatives to
the JPT. It is anticipated that the total number of
representatives on the JPT will fluctuate depending on the
then-current requirements under the Research Plan and the
Development Plan, however the total number of
representatives shall not exceed ten (10). The position of
chairperson shall rotate between the Parties annually. The
chairperson during the first year of the term hereof will be
an Epimmune representative. A Party may change any of its
representatives at any time by giving written notice to the
other Party. The JPT will continue in existence through the
end of the Collaboration Term.
3.3.2 RESPONSIBILITIES. Each JPT shall be responsible for
overseeing and managing all aspects of the Research Plan and
Initial Development activities with respect to Products
within its technology platform. In particular, the JPT
shall:
(a) prepare and submit the first annual Development Plan,
the Initial Development activities and the Development
Budget to the JMC for review and approval;
(b) prepare and submit to the JMC, the Rolling Research
Plan, the Research Plan and Research Budget relating to
Products within its technology platform.
(c) allocate the Research activities among Epimmune, Xxxxxx
and Third Parties in accordance with this Agreement;
(d) implement the annual Research Plan and ensure that the
program stays within the Research Budget;
(e) review progress and recommend any necessary interim
changes to the Research Plan to JMC;
(f) discuss and resolve ongoing issues;
(g) provide annual and quarterly progress reports of budget
and program activities to the JMC;
(h) provide quarterly forecasts of budget and program
activities to the JMC;
(i) provide and/or support program reviews with Xxxxxx R&D
senior management as requested from time to time;
(j) develop and implement publication strategies;
(k) support development and implementation of the clinical,
regulatory and commercial strategies carried out by
Xxxxxx following each Product Alert; and
(l) perform such other functions as agreed in writing by the
Parties.
Following the transfer of a Product to the Xxxxxx Project
Team, the JPT's responsibilities with respect to such
Product shall be limited to discovery support during
Development as provided in the Development Plan for such
Product. Any of Epimmune's responsibilities therefor shall
be set forth in the Research Plan.
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3.3.3 MEETINGS. The JPT will meet at such times as the chairperson
or either of the Project Managers may request, but in no
event less frequently than once every month. If possible,
the meetings shall be held in person, or where appropriate,
by telephone, facsimile and video conference. The
chairperson shall appoint a secretary, who shall be
responsible for circulating minutes of the meeting within
ten (10) business days following the meeting. Minutes of
each meeting shall be signed by both Project Managers. Each
Party recognizes the importance of the JPT in the success of
the collaboration contemplated hereunder and will use
diligent efforts to cause all its representatives to attend
all meetings. Additional participants may be invited by any
member to attend meetings where appropriate.
3.3.4 DISPUTE RESOLUTION. If the JPT is unable to reach consensus
on any matter relating to an item for which a Lead Party has
been designated pursuant to Sections 2.4 or 2.5, then the
relevant Lead Party shall decide such matter.
Notwithstanding the foregoing sentence, if the non-Lead
Party in good faith believes the decision of the other Party
will have a materially adverse effect on the outcome of the
Research Plan and/or the Development Plan, then such Party
may refer the issue to the JMC for resolution.
3.4 PROJECT MANAGERS. Each Party shall designate one senior representative
to serve as the primary contact person between the parties (the
"Project Manager"). Both Project Managers shall be members of the JPT
and shall be responsible for facilitating the exchange of all
Collaboration information and data between the Parties.
ARTICLE 4. COLLABORATION FUNDING
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4.1 EXPENSES. Each Party shall be responsible for bearing its own expenses
associated with its obligations to carry out the Research Plan and
Development Plan to the extent such expenses are contained in the
Research Budget and Development Budget, respectively.
4.2 BUDGET CHANGES. The JMC shall not have the right to increase either
party's portion of the Research Budget and/or Development Budget over
the commitment of such Party contained therein, without the written
consent of such Party. In any event, final approval of the Development
Budget and any changes thereto shall reside with Xxxxxx, subject to the
provisions of Section 2.4.2.
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ARTICLE 5. WARRANTY.
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5.1 Epimmune represents and warrants to Xxxxxx that:
5.1.1 the grant of the license by Epimmune to Xxxxxx of the
Epimmune Initial Technology does not conflict with any other
agreement to which Epimmune is a party;
5.1.2 other than as disclosed by Epimmune in writing prior to the
Effective Date, it has not received any notice that practice
of the inventions claimed under Epimmune Initial Technology
infringes on the patent or other legally protected
intellectual property rights of any Third Party in the
Territory and it is not aware of any basis therefor;
5.1.3 there are no pending or threatened adverse claims of
ownership, and, to the best of Epimmune's knowledge, no
facts or circumstances exist which could give rise to
adverse claims of ownership, to the Epimmune Initial
Technology;
5.1.4 all inventions, including all patents or patent applications
(and all divisions, continuations, continuations-in-part,
reissues, extensions, renewals, supplementary protection
certificates and foreign counterparts thereof), trademarks,
copyrights and proprietary, confidential technical
information and data existing as of the Effective Date and
materially relating to the license rights granted hereunder
which were originally owned by Cytel Corporation ("Cytel")
have been properly assigned irrevocably to Epimmune, and
documentation of the assignment of all such patents or
patent applications have been properly filed with the U.S.
Patent Office, submitted to foreign associates for filing
within five (5) days of the Effective Date with any
comparable government agencies outside of the United States,
and shall be diligently pursued by Epimmune; and
5.1.5 As of the date of the assignment contemplated by Section
5.1.4, Epimmune has entered into proprietary information and
assignment of inventions agreements with each of its
employees and consultants who are to do work under the
Collaboration and any inventions relating to the license
rights granted hereunder conceived or reduced to practice
following such date by persons working for Epimmune (or
Cytel only through the Effective Date) will come under the
Control of Epimmune.
5.2 Each Party warrants to the other that:
5.2.1 it has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations
hereunder;
-14-
5.2.2 the execution and delivery by it of this Agreement and the
performance of its obligations hereunder have been duly
approved by any necessary corporate action; do not require
any shareholder action or the approval and consent of any
trustee or the holders of any indebtedness which has not
been obtained; do not and will not contravene any law,
regulation, rules or order binding on it in any material
respect; and do not and will not contravene the provisions
of, or constitute an act of default under, any debenture,
mortgage contract or other agreement or instrument to which
it is a party in any material respect;
5.2.3 it will perform all its obligations hereunder in compliance
in any material respects with all applicable laws, including
the Act; and
5.2.4 it is not party to any Agreement in conflict with the rights
granted hereunder and that entering into and performing its
obligations under this Agreement will not conflict in any
material respect with its obligations to any Third Parties.
5.3 Xxxxxx represents and warrants to Epimmune that Xxxxxx will not use the
Epimmune Initial Technology or the Epimmune Project Technology for any
purpose other than the discovery and Development of royalty-bearing
Products pursuant to this Agreement.
5.4 Except as expressly set forth in this Article 5, no other express or
implied representation or warranty is made by either Party.
ARTICLE 6. LICENSE GRANT TO XXXXXX; REVIEW RIGHTS
--------------------------------------------------
6.1 Epimmune hereby grants to Xxxxxx:
6.1.1 an exclusive license, with right to sublicense, in the
Territory to make, have made, use, sell and import Products
in the Field under the Epimmune Project Technology and under
Epimmune's rights in the Joint Technology; provided,
however, that such license of Epimmune Project Technology is
granted subject to the license granted to Takara Shuzo, Co.
Ltd. ("Takara") of certain Patent Rights Controlled by
Epimmune to the extent such Patent Rights are dominated by
Epimmune Initial Technology and are filed on or before
January 26, 2000, which rights are limited to the rights to
make, use and sell products and services in the field of ex
vivo cellular therapy for treatment of cancer in Japan.
-15-
6.1.2 an exclusive license, with right to sublicense, in the
Territory to make, have made, use, sell and import Products
in the Field under the Epimmune Initial Technology;
provided, however, such grant of license shall not include
rights previously granted to Takara, which rights are
limited to the rights to make, use and sell products and
services in the field of ex vivo cellular therapy for
treatment of cancer in Japan.
6.1.3 subject to the provisions of Section 6.3, an exclusive
license, with right to sublicense, for uses of Xxxxxx
Cytokines outside the Field in the Territory under the
Epimmune Project Technology and under Epimmune's rights in
the Joint Technology.
6.2 Except as provided in Section 3.2.2(d), the licenses granted to Xxxxxx
herein shall include the right to sublicense, co-develop, co-promote
and/or co-market Products with Third Parties without obtaining
Epimmune's consent.
6.3 The grant of license by Epimmune under subsection 6.1.3 is not intended
to restrict any use by Epimmune outside the Field of Epimmune Project
Technology or, subject to the limitations contained in Section 11.1, of
Joint Technology.
6.4 Epimmune hereby grants to Xxxxxx the right to review, within the first
ninety (90) days following the Effective Date, its scientific data
relating to infectious disease Epitopes utilizing Epimmune technology
prior to disclosing such data to any Third Party (except those Third
Parties to whom Epimmune and/or its Affiliates as of September 5, 1997
may have already disclosed such information and/or with whom Epimmune
and/or its Affiliates were already engaged in discussions regarding
potential transactions relating to infectious disease Epitopes).
Following such initial review, Epimmune shall present to Xxxxxx twice
in each calendar year during the Collaboration Term, an update of such
data, except for any such data the rights to which have been granted to
a Third Party. Following such review by Xxxxxx, upon mutual agreement
(but without any obligation to do so), the Parties may enter good faith
negotiations for the license by Xxxxxx of the rights to some or all of
such technology.
ARTICLE 7. ROYALTIES; MILESTONE PAYMENTS
-----------------------------------------
7.1 In consideration of the grant of rights by Epimmune under Sections 6.1
and 6.2 and subject to the provisions of Sections 7.2 and 7.3, Xxxxxx
shall pay Epimmune royalties of:
7.1.1 [...***...] of Net Sales of Product Type 1;
7.1.2 [...***...] of Net Sales of the Epimmune Product Component
included in each Product Type 2;
-16-
7.1.3 [***] of net sales of a Xxxxxx Cytokine or Xxxxxx Product
Component included in any product (determined in a manner
consistent with that described in Section 1.26) if and only if
such Xxxxxx Cytokine is covered by at least one composition of
matter claim of the Patent Rights contained in Joint Technology.
7.2 The royalties due under Sections 7.1.1 and 7.1.2 shall be reduced by
(i) [...***...] of the total amount of royalties, if any, paid to
Third Parties under licenses existing as of the Effective Date
or future licenses granting rights to Epimmune and/or Xxxxxx
which are necessary to make, have made, use or sell any Product
Type 1 or the Epimmune Product Component of a Product Type 2;
and
(ii) [...***...] of the dollar amount, if any, by which Xxxxxx'x Cost
of Goods for Product(s) containing either [...***...] or a
[...***...] exceeds [...***...] of Xxxxxx'x Net Sales of such
Product.
provided, however, in no event shall such royalties payable to Epimmune
be reduced below [...***...] of Net Sales as a result of the
application of the foregoing clauses (i) and/or (ii).
7.3 The royalty rates specified in Section 7.1 shall be reduced by
[...***...] for any country of the Territory in which there are no
Patent Rights or the Patent Rights relating to the Product expire, are
declared invalid or no longer provide Xxxxxx the exclusive (subject to
the limitations described in Section 6.1), right to make, use and sell
the Product. A Patent Right shall be deemed invalid if the related
patent is held invalid or unenforceable by any court of competent
jurisdiction and of last resort or by any inferior court of competent
jurisdiction, tribunal or agency from which no appeal is taken.
7.4 If the Collaboration Term expires on or after December 31, 2001 and
upon such expiration, Epimmune has failed to meet its funding
obligations set forth in Section 2.2.1, [...***....]
7.5 Xxxxxx shall make payments to Epimmune upon the occurrence of
Development milestones in accordance with the provisions of Exhibit X.
Xxxxxx may make a portion of such milestone payments in accordance with
Section 8.1 of that certain Stock Purchase Agreement of even date
herewith between Xxxxxx and Cytel.
-17-
ARTICLE 8. PAYMENT; TAXES; AUDIT RIGHTS
----------------------------------------
8.1 Royalties due to Epimmune under this Agreement for each calendar
quarter of the term hereof shall be paid by Xxxxxx or its sublicensees
in United States Dollars within sixty (60) days following the end of
each such calendar quarter. Each payment of royalties made to Epimmune
hereunder shall be accompanied by a written report, clearly showing the
Net Sales for the months of the quarter for which payment is being made
and the calculation of royalties due. Foreign currency conversions into
United States Dollars shall be made monthly at the rate of exchange
published in the Midwest edition of The Wall Street Journal for the
currency of the applicable country on the last business day of the
calendar month for which Net Sales were made.
8.2 All payments to be made by Xxxxxx pursuant to Article 7 shall be made
in immediately available funds in United States dollars by wire
transfer to such bank and account of Epimmune as may be designated from
time to time by Epimmune.
8.3 Payments under Article 7 shall not be reduced by any taxes, licenses,
fees or other withholdings levied upon such payments by the government
of any country, or political subdivisions or agencies thereof, from
which Xxxxxx makes the payment unless all of the following requirements
are met:
8.3.1 the amount, if any, by which the payments are reduced, is a
tax imposed on royalties or income and is not an excise,
franchise, privileges turnover, sales, production, value
added, or property tax, or any other type of levy or duty;
8.3.2 the tax is imposed on Epimmune under the laws of the
relevant country in the Territory, and Xxxxxx is required by
law to withhold the tax from payments to Epimmune and to pay
such tax to the government, or political subdivision or
agency thereof, of such country; and
8.3.3 Xxxxxx furnishes Epimmune with a tax receipt for the taxes
withheld within sixty (60) days of payment thereof or such
other documentation as Epimmune may reasonably require in
order that Epimmune may credit such amount in full against
its own tax liabilities.
All taxes, licenses, fees or other levies or duties imposed upon Xxxxxx
or which arise because of payments to Epimmune by Xxxxxx under this
Agreement, other than those which meet the requirements of subsections
8.3.1, 8.3.2, and 8.3.3, shall be paid and absorbed by Xxxxxx.
-18-
8.4 Xxxxxx shall keep and maintain for two (2) years after payment of
royalties, complete and accurate books and records in sufficient detail
so that royalties payable hereunder and/or any deductions thereto can
be properly calculated.
8.5 No more frequently than once during each year of the term of this
Agreement, Xxxxxx shall permit Epimmune's independent auditors, to whom
Xxxxxx has no reasonable objection and with reasonable notice at any
time during normal business hours, to inspect and audit such accounts
and records of Xxxxxx for the sole purpose of verifying the accuracy of
the royalty payments submitted to Epimmune and the reports which
accompanied them. Epimmune's independent auditors shall not disclose to
Epimmune or any Third Party any information other than information
relating solely to the accuracy of the accounting and payments made by
Xxxxxx. Any such inspection of Xxxxxx'x records shall be at Epimmune's
expense unless such audit discloses a deficiency in the amount of Net
Sales reported by Xxxxxx of more than 5% of the actual amount of Net
Sales, in which case Xxxxxx shall bear the full cost of such audit.
ARTICLE 9. DISCLOSURE OF KNOW-HOW AND IMPROVEMENTS
---------------------------------------------------
9.1 Promptly after execution of this Agreement by both Parties and promptly
after discovery or acquisition during the term of this Agreement,
Epimmune shall disclose to Xxxxxx in writing all Know-How included in
the Epimmune Initial Technology, the Epimmune Project Technology and/or
the Joint Technology. Promptly after discovery or acquisition during
the Collaboration Term, Xxxxxx shall disclose to Epimmune in writing
all Know-How included in the Xxxxxx Project Technology and the Joint
Technology.
9.2 During the Collaboration Term and for a period of [...***...]
thereafter, Epimmune shall disclose to Xxxxxx in writing promptly after
discovery or acquisition all Improvements which are dominated by the
Epimmune Initial Technology, the Epimmune Project Technology and/or the
Joint Technology. Xxxxxx, at its option, may include said Improvements,
whether patented or not, within the rights granted hereunder,
[...***....]
ARTICLE 10. SUPPLY
-------------------
Each Party, at its own expense, shall supply to the other Party its Product
Component for the conduct of the Research activities, provided that [...***...]
required for activities under the Research Plan and Development Plan shall be
supplied, at Xxxxxx'x expense, by Xxxxxx, Cytel or a Third Party. Xxxxxx shall
be responsible for manufacturing or causing to be manufactured Products and
Product Components required under the Development Plan and following Launch
Date(s).
-19- CONFIDENTIAL TREATMENT REQUESTED
ARTICLE 11. INTELLECTUAL PROPERTY RIGHTS.
------------------------------------------
11.1 JOINT TECHNOLOGY.
11.1.1 Each party shall have the royalty-free right to use Joint
Technology freely, subject to the licenses granted under the
provisions of Article 6 and to the provisions contained in
Sections 11.1.2 and 15.5.4.
11.1.2 Except as provided in Section 15.5.4, Epimmune shall have no
right to practice or sublicense Joint Technology to the
extent it includes Xxxxxx Cytokines. For the avoidance of
doubt, in the event Joint Technology is useful for any
purpose other than in connection with Xxxxxx Cytokines, this
Section 11.1.2 is not intended to preclude Epimmune from
using Joint Technology in connection with such other
purposes.
11.2 PATENTABLE INVENTIONS.
11.2.1 Xxxxxx shall own solely all Xxxxxx Project Technology,
including all Patent Rights with respect thereto, and
Epimmune shall own solely all Epimmune Project Technology,
including all Patent Rights with respect thereto.
11.2.2 The Parties shall own jointly all Joint Technology including
all Patent Rights thereto. Each Party shall have the right
to make, have made, use or sell any such Joint Technology
only as permitted in Section 11.1.
11.2.3 Enforcement of Intellectual Property Rights relating to any
such Project Technology or Joint Technology shall be
governed by Section 11.6.
11.3 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
11.3.1 Except as provided in Section 3.2.2(j), each Party, at its
expense, shall be responsible for filing, prosecuting and
maintaining the Patent Rights included in its respective
Initial Technology and Project Technology. If a Party
decides not to pursue patent protection for any invention
claimed in any patent application or patent within such
Patent Rights in any country, it shall give the other Party
reasonable notice thereof. The other Party, at its expense,
may file, prosecute or maintain a patent application or
patent covering such invention, and the ownership of such
invention will not be affected.
-20-
11.3.2 The Parties will develop a joint strategy for filing,
prosecution and maintenance worldwide of the Patent Rights
included in the Epimmune Project Technology, Xxxxxx Project
Technology and Joint Technology with the understanding that
they will attempt to reach mutual agreement upon such
matters. In the event that the Parties are unable to reach
mutual agreement, Epimmune will have responsibility with
respect to all Patent Rights included in the Epimmune
Project Technology and Joint Technology which cover Epitope
identification or compositions and PADRE, and Xxxxxx will
have responsibility for all Patent Rights included in the
Xxxxxx Project Technology and all other Joint Technology.
The Parties shall share equally all expenses for filing,
prosecution and maintaining the Patent Rights included in
Joint Technology.
11.3.3 Xxxxxx will have the opportunity to provide significant
input to the filing and prosecution strategy for all Patent
Rights included in the Epimmune Initial Technology, Epimmune
Project Technology, and Joint Technology relevant to the
Field for which Epimmune has responsibility. Patent counsel
for each Party will meet regularly to discuss strategy, and
Xxxxxx shall have at least thirty (30) days to provide input
and comments on any significant patent actions. Epimmune
shall have the final say with respect to such actions. In
the event that Epimmune elects to abandon any of the Patent
Rights included in the Epimmune Initial Technology, Epimmune
Project Technology, or Joint Technology relevant to the
Field for which it is responsible in any country of the
Territory (unless such abandonment occurs because the
subject matter of the abandoned patent is covered by other
Patent Rights included in the Epimmune Initial Technology,
Epimmune Project Technology or Joint Technology), Xxxxxx
shall have the right to assume such patent or patent
application.
11.3.4 Epimmune will have the opportunity to provide significant
input to the filing and prosecution strategy for all Patent
Rights included in the Xxxxxx Project Technology and Joint
Technology relevant to the Field for which Xxxxxx has
responsibility, and Xxxxxx agrees, within reason, to include
claims which might be useful for applications outside the
Field. In the event that Xxxxxx elects to abandon any of the
Patent Rights included in the Xxxxxx Project Technology or
Joint Technology relevant to the Field for which it is
responsible (or claims of interest to Epimmune) in any
country of the Territory, Epimmune shall have the right to
assume such patent or patent application.
11.4 PATENT EXTENSIONS. If agreed by the JMC, the Parties shall apply in a
timely manner for such patent term extensions or supplemental
protection certificates for the Patent Rights relating to an invention
made hereunder as are available under any applicable legislation. All
expenses incurred in connection with such patent term extensions or
supplemental protection certificates shall be paid by the Party
(or Parties in the case of Joint Technology) responsible for the
prosecution and maintenance of the applicable Patent Rights.
-21-
11.5 COOPERATION. Each Party shall sign or have its appropriate employees
and agents sign such documents as may be necessary to obtain, perfect
or maintain any Patent Rights filed or to be filed pursuant to this
Agreement, and shall furnish all information in its possession
reasonably necessary in connection therewith.
11.6 INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.
11.6.1 (a) If either Party becomes aware of any infringement or
threatened infringement or misappropriation of any
Intellectual Property Rights in the Field, it shall
promptly notify the other Party in writing. The Party
responsible for the prosecution and maintenance of such
Intellectual Property Rights under Section 11.3, at its
expense (subject to subsection 11.6.1(b)), shall have
the right, but not the obligation, to institute,
prosecute and control any legal proceeding in its name
and by its counsel to prevent or restrain such
infringement in the Field. If such Party declines to
institute legal proceedings, the other Party shall have
the right to institute, prosecute and control any legal
proceeding in its name and by its counsel to prevent or
restrain such infringement in the Field. The Party
asserting such Intellectual Property Rights will deduct
and retain from any and all amounts recovered from Third
Parties the amount of all reasonable costs and expenses
incurred by it in prosecuting such legal proceeding. Any
remaining amounts recovered from such Third Parties
shall be shared by the Parties; [...***...] to the Party
which asserted such Intellectual Property Rights and
[...***...] to the other Party.
(b) The Parties shall determine which Party shall have the
primary right and responsibility (but not the
obligation) to institute, prosecute, and control any
proceeding with respect to infringement or
misappropriation of Joint Technology. If a Party brings
any such proceeding, the other Party agrees to be joined
as a party plaintiff if required to enforce Patent
Rights related to Joint Technology. In such case, the
other Party will give such Party reasonable assistance
and authority to file and prosecute such suit. Any
damages or monetary recovery shall be split equally
between the Parties, after payment of each Party's legal
costs and expenses.
-22-
11.6.2 In connection with any proposed settlement with respect to
any infringement or threatened infringement of any
Intellectual Property Rights, the Party intending to settle
shall notify and consult with the other Party as to the
terms of settlement. The other Party's written consent,
which shall not be unreasonably withheld, shall be required
prior to any such settlement.
11.6.3 In connection with any action taken by either Party against
a Third Party to protect or enforce any Intellectual
Property Rights, the other Party shall, if requested,
consult with the Party taking such action, and make
available as witnesses its employees or as evidence any
materials and/or data as are reasonably necessary for the
furtherance of such action. The expenses in connection with
the providing of witnesses and/or the making available of
any materials and/or data shall be borne by the Party
incurring them, and reimbursed by the Party bringing such
action pursuant to subsection 11.6.1(a).
11.7 INFRINGEMENT OF THIRD PARTY PATENT RIGHTS. If either Party is sued for
patent infringement of any Third Party patents arising out of the
manufacture, use, sale or importation of any Product, the Parties shall
promptly meet to discuss the course of action to be taken to resolve or
defend any such infringement litigation. Subject to the indemnification
provisions of Article 16, a Party shall assume the defense of such
action if the infringement relates solely to the use of such Party's
Initial Technology; provided, however, if an action is brought alleging
that Epimmune Initial Technology is infringing any Third Party patents,
Xxxxxx shall have the right to participate fully at its expense in the
defense of such action. Each Party shall provide the other with such
assistance as is reasonably necessary and shall cooperate in the
defense of any such action.
11.8 THIRD PARTY TECHNOLOGY. Xxxxxx will use commercially reasonable efforts
to obtain rights to any Third Party patents it deems necessary to
commercialize the Products.
ARTICLE 12. LICENSE GRANT TO EPIMMUNE
--------------------------------------
12.1 Xxxxxx hereby grants to Epimmune a non-exclusive license, with right to
sublicense, in the Territory to make, have made, use and sell Products
outside of the Field under the Xxxxxx Project Technology; provided,
however, except as provided in Section 15.5.5, Epimmune shall have no
right to practice or sublicense Xxxxxx Project Technology to the extent
it includes Xxxxxx Cytokines. For the avoidance of doubt, in the event
Xxxxxx Project Technology is useful for any purpose other than in
connection with Xxxxxx Cytokines, this Section 12.1 is not intended to
preclude Epimmune from using Xxxxxx Project Technology in connection
with such other purposes.
12.2 In consideration of the grant of license rights by Xxxxxx under Section
12.1, Epimmune shall pay Xxxxxx (i) in the case where Epimmune and/or
its Affiliates sell products which are covered by at least one claim of
the Patent Rights contained in the Xxxxxx Project Technology outside of
the Field directly to Third Parties, royalties on Epimmune's Net Sales
of such products by Epimmune and/or its Affiliates at the rate of
-23-
[...***...] and (ii) in the case where Epimmune licenses products which
are covered by at least one claim of the Patent Rights contained in the
Xxxxxx Project Technology outside of the Field to any Third Party,
[...***...] of the royalties actually received by Epimmune from any
such Third Party for the license of such product up to a maximum of
[...***...] of such Third Party's Net Sales of such products.
12.3 In consideration of the disclosure of information to Takara permitted
under Section 13.3, Epimmune shall pay or cause to be paid to Xxxxxx
the following royalties, as applicable, on the net sales of products
and services which use, incorporate or are developed based on such
information:
12.3.1 [...***...] if royalties owed to Epimmune by Takara, after
payment by Epimmune of all Third Party royalties except
those owed to Xxxxxx hereunder, are [...***...] or greater;
12.3.2 [...***...] if royalties owed to Epimmune by Takara, after
payment by Epimmune of all Third Party royalties except
those owed to Xxxxxx hereunder, are [...***...] or greater;
and
12.3.1 If royalties owed to Epimmune by Takara, after payment by
Epimmune of all Third Party royalties except those owed to
Xxxxxx hereunder, are between [...***...] and [...***...]
Xxxxxx'x royalty shall be [...***...] less one third of the
amount royalties to Epimmune are reduced below [...***....]
12.4 The provisions of Sections 1.26 and 7.3 and Article 8 shall apply
mutatis mutandis to Epimmune with respect to all royalties payable by
Epimmune hereunder.
ARTICLE 13. CONFIDENTIAL INFORMATION.
--------------------------------------
13.1 INFORMATION. Each Party shall keep all information received from the
other Party hereunder or pursuant to any of the Prior Agreements or
developed during the term hereof (the "Information") confidential and
shall not disclose nor use the Information without the other Party's
written consent except to the extent contemplated by this Agreement.
This restriction shall not, however, prevent disclosure of the
Information if and to the extent that disclosure is required by law,
PROVIDED that the disclosing Party first informs the other Party
without delay of any such requirement to allow such other Party to
object to such disclosure and to seek an appropriate protective order
or similar protection prior to disclosure. This obligation shall
survive for five (5) years after termination or expiration of this
Agreement.
-24- CONFIDENTIAL TREATMENT REQUESTED
13.2 EXCEPTIONS. The above obligations shall not apply or shall cease to
apply if such Information:
(a) has become generally available to the public otherwise than through
violation of this Agreement;
(b) was already in the recipient's possession prior to its acquisition
from the disclosing Party (other than Information provided under
the Prior Agreements);
(c) has been received from a Third Party who is not under any
obligation of confidentiality; or
(d) has been independently developed by the receiving Party (except for
Information developed pursuant to this Agreement) without the aid
or use of Information of the disclosing Party as supported by
competent written proof.
13.3 PERMITTED DISCLOSURES. Information may be disclosed to a Party's
Affiliates and agents, consultants, permitted sublicensees, suppliers
or subcontractors of the recipient Party, but only to the extent
required to accomplish the purposes of this Agreement and only if the
receiving Party obtains prior written agreement from such individuals
and/or entities to hold in confidence and not use such Information for
any purpose other than those permitted by this Agreement. Subject to
the provisions of the following sentence, information developed during
the term hereof may be disclosed (a) by Epimmune to its potential
partners or licensees in connection with a corporate partnership
license or similar arrangement outside the Field, provided all clinical
data developed hereunder is excluded from any such disclosure unless
otherwise agreed in writing by Xxxxxx; and (b) by Xxxxxx to its
potential corporate partners or sub-licensees in connection with a
sublicense, co-development, co-promotion or similar arrangement in the
Field. No such disclosure shall occur until the disclosing Party enters
into a written confidentiality agreement with such potential corporate
partner, licensee or sub-licensee to protect the confidentiality of
such Information. Information that is preclinical and clinical data
provided in the course of the Collaboration during the Collaboration
Term may be disclosed by Epimmune to Takara under the Collaboration
Agreement between Takara and Cytel (predecessor-in-interest to
Epimmune), dated October 18, 1994, as amended, for use by Takara in the
development of its program in the field of ex vivo cellular therapy for
treatment of cancer in Japan, subject to the provisions of Section
12.3. Each Party will use at least the same standard of care as it uses
to protect proprietary or confidential information of its own to ensure
that such individuals and/or entities do not disclose or make any
unauthorized use of the Information.
-25-
13.4 PUBLICITY AND DISCLOSURE OF AGREEMENT. All publicity relating to this
Agreement shall be subject to the approval of both Parties. Except as
required by law, neither Party shall disclose any non-public
information with respect to the terms of this Agreement or concerning
the collaboration hereunder without the prior written consent of the
other Party, which consent will not be unreasonably withheld or
delayed. If either Party is required by securities laws or regulations
to disclose the existence of this Agreement or its contents, then the
disclosing Party shall notify the other Party of its disclosure
obligations and shall obtain such other Party's consent, which may not
be unreasonably withheld, to the form and content of such disclosure.
Notwithstanding any other provision of this Agreement, each Party may
disclose the terms of this Agreement to lenders, investment bankers and
other financial institutions solely for purposes of financing its
operations if the disclosing Party uses reasonable efforts to obtain a
signed confidentiality agreement with such financial institution with
respect to such information, upon terms substantially similar to those
contained in this Section.
13.5 PUBLICATION. The Parties shall cooperate in appropriate publication of
the results of Research and Development work performed pursuant to this
Agreement, subject to the predominating interest in obtaining patent
protection for any patentable subject matter. Prior to any public
disclosure of such results, the Party proposing disclosure shall send
the other Party a copy of the information to be disclosed. The other
Party shall have thirty (30) days from receipt to determine whether the
information to be disclosed contains subject matter for which patent
protection should be sought prior to disclosure, or otherwise contains
Information of the reviewing Party which such Party desires to maintain
as a trade secret. If notification is not received during the thirty
(30) day period, the Party proposing disclosure shall be free to
proceed with the disclosure. If due to a reasonable belief by the
non-disclosing Party that the disclosure contains confidential
Information for which a patentable invention should be sought, then
prior to the expiration of the thirty (30) day period, the
non-disclosing Party shall so notify the disclosing Party, which shall
then delay public disclosure of the Information for an additional
period of up to six (6) months to permit the preparation and filing of
a patent application on the Information to be disclosed or other action
to be taken. The Party proposing disclosure shall thereafter be free to
publish or disclose the Information. The determination of authorship
for any paper shall be in accordance with accepted scientific practice.
ARTICLE 14. TERM.
------------------
14.1 TERM. This Agreement shall be in effect from the Effective Date and,
unless earlier terminated pursuant to the terms of Article 15, shall
continue in effect, on a Product-by-Product and country by country
basis, until the later of (i) the last to expire of the patents
included in the Epimmune Initial Technology, Epimmune Project
Technology or Joint Technology, or (ii) the tenth (10th) anniversary of
the Launch Date. Epimmune's obligation to pay royalties to Xxxxxx for
products outside the Field, and the provisions of Article 12 shall be
in effect from the Effective Date and, unless earlier terminated
pursuant to the terms of Article 15, shall continue in effect, on a
product-by-product and country by country basis, until the later of (i)
the last to expire of the patents included in the Xxxxxx Project
Technology, or (ii) the tenth (10th) anniversary of the date of the
first sale of a product to a Third Party by Epimmune, its Affiliates or
sublicensees through customary commercial channels of distribution.
-26-
14.2 EXPIRY. Upon the expiration of this Agreement, on a country by country
basis, (a) Xxxxxx shall have a fully paid up, perpetual, royalty-free,
non-exclusive license under the Epimmune Initial Technology and the
Epimmune Project Technology, and (b) Epimmune shall have a fully paid
up, perpetual, royalty-free, non-exclusive license under the Xxxxxx
Project Technology.
ARTICLE 15. TERMINATION
------------------------
15.1 RESEARCH COLLABORATION.
15.1.1 The Parties have agreed to participate in the Collaboration
until the earlier of the Completion of the Research Plan or
the date that Epimmune has met its obligation under the
Research Budget as contemplated under Subsection 2.2.1,
which is anticipated to be an initial four year period
ending December 31, 2001 (such period, as may be extended or
earlier terminated, is referred to herein as the
"Collaboration Term"). At least six (6) months prior to the
end of the Collaboration Term, Xxxxxx shall inform Epimmune
in writing whether it wishes to extend the Collaboration
Term. If, within three months following such notice from
Xxxxxx, the Parties have not agreed on the funding of the
Collaboration for an additional period, then the
Collaboration will terminate. In the event of any such
termination, all terms and conditions (except Articles 2, 3
and 4) of this Agreement shall continue in full force and
effect, and Xxxxxx may continue Development of the Products.
Epimmune shall provide Xxxxxx with all documentation in its
possession relevant to such Research and Development and
shall cooperate with Xxxxxx to transfer Epimmune's Research
and Development activities to Xxxxxx or its designee.
15.1.2 Beginning at any time after the first anniversary of the
Effective Date, the Collaboration and the Collaboration Term
may be terminated by Xxxxxx at any time for any reason or no
reason by giving Epimmune at least ninety (90) days prior
written notice. In the event of any such termination, all
terms and conditions (except Articles 2, 3 and 4) of this
Agreement shall continue in full force and effect and,
Xxxxxx may continue Development of the Products. Epimmune
shall provide Xxxxxx with all documentation in its
possession relevant to such Research and Development and
shall cooperate with Xxxxxx to transfer Epimmune's Research
and Development activities to Xxxxxx or its designee.
-27-
15.2 VOLUNTARY TERMINATION. Xxxxxx shall have the right to terminate this
Agreement without cause at any time by giving Epimmune at least ninety
(90) days prior written notice.
15.3 BREACH. Either Party may terminate this Agreement upon sixty (60) days'
written notice if the other Party commits a material breach of any of
its obligations hereunder and such other Party does not remedy such
breach within said sixty (60) days, or, if such breach is not capable
of cure within said sixty (60) days, does not commence remedy of such
breach within such sixty (60) days.
15.4 INSOLVENCY. Either Party shall have the right to terminate this
Agreement at any time by giving the other Party written notice,
effective immediately, if such other Party is dissolved or liquidated,
files or has filed against it a petition under any bankruptcy or
insolvency law, makes an assignment for the benefit of its creditors or
has a receiver appointed for all or substantially all of its property.
15.5 EFFECT OF TERMINATION.
15.5.1 INTELLECTUAL PROPERTY RIGHTS. Following the termination of
this Agreement for any reason (a) all Intellectual Property
Rights owned by each Party as of the Effective Date shall
continue to be owned exclusively by such Party, subject to
the rights of each Party contained in this Agreement, and
(b) any Intellectual Property Rights relating to Joint
Technology shall continue to be jointly owned, subject to
the rights of each Party contained in this Agreement.
15.5.2 VOLUNTARY TERMINATION; BREACH.
15.5.2.1 If Xxxxxx terminates this Agreement under
subsection 15.2, or if Epimmune terminates
this Agreement under subsection 15.3, then,
except as provided in subsection (d) below,
(a) with respect only to Products which were
launched and Products for which
applications for Regulatory Approvals
were submitted as of the date such
termination is effective, Xxxxxx shall
continue to have the license rights
granted hereunder and make all royalty
payments and, if applicable, milestone
payments for such Products in accordance
with Articles 7 and 8 of this Agreement.
-28-
(b) except as provided in Subsection
15.5.2.1(a),
(i) Xxxxxx shall (1) have no further
rights under Epimmune Initial
Technology or Epimmune Project
Technology or Epimmune's rights in
the Joint Technology and the
licenses granted under Article 6
shall terminate, (2) if necessary,
grant Epimmune the license rights
provided under Section 15.5.4, (3)
return to Epimmune all data and
technical information relating to
such Technology, and (4) cooperate
with Epimmune to transfer Xxxxxx'x
Development activities directly
related to such Technology to
Epimmune or its designee, except
any such activities relating to
Xxxxxx Cytokines other than as
specifically provided in Section
15.5.4, and
-28-
(ii) Epimmune shall (1) have the right
to assume any agreements with any
Third Party for the grant of
license rights for the use of
and/or supply of such Third
Party's Cytokines, (2) upon the
commercialization of any such
Products, in consideration of the
grant of license rights provided
under Section 15.5.4, pay Xxxxxx:
(A) in the case where Xxxxxx
terminates this Agreement
under Section 15.2, a royalty
on the Net Sales of Product
Type 1 or the Epimmune
Product Component included in
any Product Type 2 sold by
Epimmune, its Affiliates or
sublicensees in the Field at
the following rates on a
Product-by-Product basis
depending on the stage of
Development achieved when
termination occurs:
Royalty If termination occurs when the Product is
------- -----------------------------------------
Rate in the following stage of Development:
---- --------------------------------------
[...***...] prior to the initiation of Phase I
[...***...] during Phase I or Phase II studies
[...***...] upon Phase II completion or during Phase III
[...***...] upon Phase III completion with a submittable
application for Regulatory Approval in a Key
Market
(B) in the case where Epimmune
terminates this Agreement
under Section 15.3, a
royalty on the Net Sales
of Product Type 1 or the
Epimmune Product Component
included in any Product
Type 2 sold by Epimmune,
its Affiliates or
sublicensees in the Field
at the following rates on
a Product-by-Product basis
depending on the stage of
Development achieved when
termination occurs:
-29- CONFIDENTIAL TREATMENT REQUESTED
Royalty If termination occurs when the Product is
------- -----------------------------------------
Rate in the following stage of Development:
---- --------------------------------------
[...***...] prior to the initiation of Phase I
[...***...] during Phase I or Phase II studies
[...***...] upon Phase II completion or during Phase III
[...***...] upon Phase III completion with a submittable
application for Regulatory Approval in a Key
Market
(C) in the case where either
Xxxxxx terminates this
Agreement under Section
15.2 or Epimmune
terminates this Agreement
under Section 15.3, Net
Sales of the Xxxxxx
Product Component packaged
alone or included in any
Product Type 2 sold by
Epimmune, its Affiliates
or sublicensees in the
Field at the higher of the
following rates:
(i) [ *** ] for a
Xxxxxx Cytokine
covered by at
least one
composition of
matter claim of
the Patent Rights
contained in Joint
Technology; and
(ii) [ *** ] for a
Xxxxxx Cytokine
covered by at
least one claim of
the Patent Rights
contained in
Xxxxxx Initial
Technology or
Xxxxxx Project
Technology.
(c) The provisions of Sections 1.26, 7.2(i)
(except with respect to Xxxxxx
Cytokines) and 7.3 and Article 8 shall
apply mutatis mutandis to Epimmune with
respect to all royalties payable by
Epimmune under this Section 15.5.2.
(d) Notwithstanding the provisions of
subsection (a) above, if Epimmune
terminates this Agreement under
subsection 15.3 due to Xxxxxx'x failure
to make a royalty payment required
hereunder which is not the subject of a
good faith dispute, then subsection (a)
above shall not apply and subsection (b)
shall also apply to any Products which
were launched and/or for which
applications for Regulatory Approvals
were submitted as of the date such
termination is effective. With respect
only to any such Products which were
launched and/or for which applications
for Regulatory Approvals were submitted
as of the date such termination is
effective, Epimmune shall pay Xxxxxx a
royalty of [...***...] on the Net Sales
of any Product Type 1 or the Epimmune
Product Component included in any
Product Type 2 sold by Epimmune, its
Affiliates or sublicensees in the Field.
-30- CONFIDENTIAL TREATMENT REQUESTED
15.5.2.2 If Xxxxxx terminates this Agreement under
Subsection 15.3, Xxxxxx shall have the
continuing right to make, have made, use,
sell and import Products in the Field as
provided in this Agreement, subject to the
payment of all royalties and milestone
payments due hereunder, except that all
milestone payments which become due after the
date such termination is effective shall be
reduced by [...***....]
15.5.2.3 If Xxxxxx terminates this Agreement under
Subsection 15.3 and Epimmune has failed to
meet its funding obligations defined in
Section 2.2.1 under the Collaboration,
[...***...]
15.5.3 INSOLVENCY.
15.5.3.1 In the event Epimmune becomes a debtor under
the Bankruptcy Code, all rights and licenses
granted under or pursuant to this Agreement
by Epimmune to Xxxxxx are, and shall
otherwise be deemed to be, for purposes of
Section 365(n) of the Bankruptcy Code,
licenses of rights to "intellectual property"
as defined under Section 101(35)(a) of the
Bankruptcy Code. The Parties agree that
Xxxxxx, in addition to the rights granted to
it under this Agreement, as licensee of
rights under this Agreement, shall retain and
may fully exercise all of its rights and
elections under the Bankruptcy Code. If a
bankruptcy proceeding is commenced by or
against Epimmune under the Bankruptcy Code,
Xxxxxx shall be entitled to a complete
duplicate of (or complete access to, as
appropriate) any such intellectual property
and all embodiments of such intellectual
property upon written request therefor by
Xxxxxx. Such intellectual property and all
embodiments thereof shall be promptly
delivered to Xxxxxx: (a) upon any such
commencement of a bankruptcy proceeding upon
written request by Xxxxxx, unless Epimmune
elects to continue to perform all of its
obligations under this Agreement; or (b) if
not delivered under (a) above, upon the
rejection of this Agreement by or on behalf
of Epimmune upon written request by Xxxxxx.
Epimmune shall not interfere with the rights
of Xxxxxx as provided in this Agreement, or
any agreement supplementary hereto, to such
intellectual property (including all such
embodiments thereof), including any right of
Xxxxxx to obtain such intellectual property
(or such embodiment) from any other entity.
-31- CONFIDENTIAL TREATMENT REQUESTED
15.5.3.2 The provisions of the following sentence
shall apply if Epimmune becomes a debtor
under the Bankruptcy Code and if, in any
bankruptcy proceeding relating thereto,
Xxxxxx should lose the license rights granted
by Epimmune in Section 6.1 with respect to
any of the top fifteen (15) pharmaceutical
markets in the world based on published IMS
data at the time of such loss. In such event,
the cumulative milestone payments set forth
on Exhibit E shall be reduced by (a)
[...***...] if Xxxxxx loses such rights in
one of such top fifteen (15) pharmaceutical
markets, and (b) [...***...] if Xxxxxx loses
such rights in two or more of such fifteen
(15) pharmaceutical markets.
15.5.3.3 During the term of this Agreement, Epimmune
shall not grant any Third Party, other than a
banking institution or other similar
institution engaged primarily in the business
of lending money or extending credit, a
security interest in the Intellectual
Property Rights.
15.5.4 GRANT OF LICENSE TO EPIMMUNE.
15.5.4.1 In the event this Agreement is terminated by
Xxxxxx pursuant to Section 15.2 or by
Epimmune pursuant to Section 15.3, then
Xxxxxx shall grant to Epimmune a
semi-exclusive, worldwide license, with right
to sublicense, under
(a) Xxxxxx Project Technology and Xxxxxx'x
rights under Joint Technology to make,
have made, use and sell Products in the
Field; provided, however, Epimmune shall
have no right to practice or sublicense
Xxxxxx Project Technology or Joint
Technology for uses of Xxxxxx Cytokines
except to the extent necessary to use a
Xxxxxx Cytokine that was included in the
formulation of a Product in Development
under the Development Plan at the time
of notice of such termination, and
-32- CONFIDENTIAL TREATMENT REQUESTED
(b) Xxxxxx Initial Technology for uses of
Xxxxxx Cytokines only to the extent
necessary to make, have made, use and
sell Products in the Field which use a
Xxxxxx Cytokine that was included in the
formulation of a Product in Development
under the Development Plan at the time
of notice of such termination.
For the avoidance of doubt, if more than one
(1) Xxxxxx Cytokine was evaluated for use in
the formulation of any Product, the license
granted under this Section 15.5.4.1 shall
apply only to the Xxxxxx Cytokine(s) selected
by Epimmune for use in such Product. Also,
for the avoidance of doubt, if Epimmune
sublicenses the rights granted under this
Section 15.5.4.1, any such sublicensee shall
have no right whatsoever to use the Xxxxxx
Initial Technology, Xxxxxx Project Technology
or Xxxxxx'x rights under the Joint Technology
for any purpose other than the express grant
of rights provided herein.
Any such license shall contain applicable
warranties by Xxxxxx to Epimmune similar to
those made by Epimmune in Section 5.1. In
connection with the grant of such license,
Xxxxxx shall disclose to Epimmune in writing
all Know-How included in the Xxxxxx Project
Technology and Joint Technology licensed to
Epimmune that was not previously disclosed to
Epimmune and all Know-How included in the
Xxxxxx Initial Technology relating to the
specific Xxxxxx Cytokine(s) evaluated in
connection with the Development of the
Products described in Sections 15.5.4.1(a)
and (b).
15.5.4.2 In consideration of the license granted under
Section 15.5.4.1, Epimmune shall pay Xxxxxx
the royalties provided in Section
15.5.2.1(b)(C).
15.5.4.3 In connection with the license granted under
Section 15.5.4.1, Xxxxxx shall have the
option, in its sole discretion and upon
commercially reasonable terms to be agreed by
the Parties, to either (i) provide Epimmune
with the enabling technology to manufacture
any Xxxxxx Cytokines contained in any Product
covered by such license, or (ii) supply
Epimmune with any such Xxxxxx Cytokines on
such commercially reasonable terms, which
terms shall be no less favorable than those
granted by Xxxxxx to Third Parties for the
purchase of Xxxxxx Cytokines or, if no Third
Parties purchase Xxxxxx Cytokines, of a
compound or product utilizing novel
technology similar to Xxxxxx Cytokines.
-33-
15.6 SURVIVAL AND EFFECT OF TERMINATION. The provisions of Sections 11.1 and
14.2 and Articles 8, 12, 13 (excluding Sections 13.4 and 13.5), 15 and
16 shall survive termination or expiration of this Agreement.
Termination or expiration of this Agreement shall not deprive either
Party of any rights or remedies either at law or in equity or relieve
either Party of any of its obligations incurred prior to such
termination or expiration. The Parties shall cooperate in good faith to
wind-down the Development in order to minimize disruption of the
Development and/or commercialization efforts.
ARTICLE 16. INDEMNIFICATION.
-----------------------------
16.1 IN FAVOR OF XXXXXX. Epimmune agrees to indemnify, defend and hold
Xxxxxx harmless from and against any and all damages, losses,
liabilities (including without limitation product liability with
respect to Epimmune Technology) costs and expenses (including
reasonable costs and attorneys fees) arising from any claim, lawsuit or
other action made or brought against Xxxxxx as a result of (a) any
negligent or willful act or omission of Epimmune, or (b) the breach of
any provision, term, warranty or representation made by Epimmune
herein; or (c) any claim alleging the infringement of a Third Party's
intellectual property rights by the importing, making, using or selling
Epimmune Initial Technology in the importing, making, using or selling
of any Product.
16.2 IN FAVOR OF EPIMMUNE. Xxxxxx agrees to indemnify, defend and hold
Epimmune harmless from and against any and all damages, losses,
liabilities (including without limitation product liability with
respect to Xxxxxx Technology) costs and expenses (including reasonable
costs and attorneys fees) arising from any claim, lawsuit or other
action made or brought against Epimmune as a result of (a) any
negligent or willful act or omission of Xxxxxx, or (b) the breach of
any provision, term, warranty or representation made by Xxxxxx herein;
or (c) any claim alleging the infringement of a Third Party's
intellectual property rights by the importing, making, using or selling
Xxxxxx Initial Technology in the importing, making, using or selling of
any Product.
16.3 LIMITATION. Notwithstanding anything to the contrary set forth above or
elsewhere herein, in no event shall either Party be (a) required to
indemnify the other party for such other Party's negligence or
intentional misconduct, or (b) responsible for the lost profits,
consequential or indirect damages of the other Party.
16.4 NOTICE. Should any claim arise which could reasonably lead to a claim
or demand for indemnification, the Party seeking indemnification
("Indemnified party") shall promptly notify the other Party
("Indemnifying party") of the claim and the facts constituting the
basis for such claim. The Indemnified party shall not settle or
compromise any such claim without the prior written consent of the
Indemnifying party, which consent shall not be unreasonably withheld.
-34-
16.5 DEFENSE. The Indemnifying party may, upon written notice to the
Indemnified party, assume the defense of any claim at its sole cost and
expense. The Indemnified party shall provide reasonable assistance in
the defense of such claim in the event the Indemnifying party assumes
the defense as set forth above.
ARTICLE 17. DILIGENT PERFORMANCE; NEW OPPORTUNITIES.
-----------------------------------------------------
17.1 DILIGENCE STANDARDS. Each Party shall use commercially reasonable and
diligent efforts to perform its respective obligations under the
Research Plan and the Development Plan, as either or both may be
amended from time to time pursuant to the term of this Agreement, and
shall ensure that such responsibilities are carried out adhering to the
highest ethical and safety standards. Each Party shall provide
qualified, experienced personnel to carry out its respective
obligations under the Research Plan and the Development Plan. As used
herein, "commercially reasonable and diligent efforts" means, unless
the parties agree otherwise, those efforts consistent with the exercise
of prudent scientific and business judgment as applied to activities
conducted with regard to other programs or products of similar
potential and market size in the pharmaceutical industry.
17.2 XXXXXX DILIGENCE.
17.2.1 Epimmune may provide 90 days written notice to Xxxxxx if, in
its opinion, Xxxxxx is not using commercially reasonable and
diligent efforts in the performance of its obligations under
the Research Plan and the Development Plan, in order for the
parties to discuss the situation and for Xxxxxx to make
diligent and continuing efforts to rectify the situation during
such 90 day period. In the event that the parties are unable to
resolve their differences within such 90 day period, such
dispute shall be submitted for resolution to the senior
executive of each Party (i.e., the President of Epimmune and
the President of Xxxxxx R&D). If the senior executives are
unable to satisfactorily resolve such dispute within 30 days of
the date it was submitted to them, then the dispute shall be
submitted for binding arbitration in accordance with Section
19.12.
17.2.2 Xxxxxx shall (i) make a determination to pursue research and
development of Products which are [...***...] and commit
sufficient resources to enable pre-clinical development of a
-35- CONFIDENTIAL TREATMENT REQUESTED
Product which is a [...***...] [...***...] by [...***...] and
(ii) issue a Product Alert for a Product which is a [...***...]
by [...***...] provided the Product candidate offered by
Epimmune meets the Product specifications provided by Xxxxxx,
such specifications to be provided as soon as practicable
following the Effective Date, and if such Product candidate
fails to meet such specifications then such date shall be
extended on a day-by-day basis for each day after [...***...]
until the date such Product candidate meeting such
specifications is provided. In the event that Epimmune has not
provided data regarding the [...***...] in accordance with the
requirements of the Research Plan by [...***...] the dates set
forth in (i) and (ii) of the preceding sentence shall be
extended on a day-by-day basis for each day after [...***...]
until the date such data is provided. In the event that Xxxxxx
does not satisfy the diligence requirements set forth in this
Section 17.2.2, then Epimmune may terminate the license granted
to Xxxxxx by Epimmune in Section 6.1 with respect to the PADRE
technology for the development of [...***...] upon written
notice to Xxxxxx.
17.2.3 In the event that, as of [...***...] Xxxxxx is not pursuing
development of any Product that is a [...***...] or has not
paid the milestone associated with a Product Alert for any
Product that is a [...***...] then Xxxxxx shall issue a Product
Alert with respect to at least one Product [...***...] and pay
the associated milestone payment by [...***....] In the event
that Xxxxxx does not satisfy the diligence requirements set
forth in this Section 17.2.3, then Epimmune may terminate the
license granted to Xxxxxx by Epimmune in Section 6.1 with
respect to [...***...] upon written notice to Xxxxxx.
17.2.4 If Xxxxxx decides not to proceed with the Development of a
Product in Development under the Development Plan, or if no
significant Development action has been taken by Xxxxxx with
respect to a Product in Development under the Development Plan,
as updated, for a period of [...***...] the provisions of this
Section 17.2.4 shall apply with respect to such Product (an
"Abandoned Product"). Xxxxxx shall promptly provide notice to
Epimmune of any decision not to proceed with a Product in
Development under the Development Plan. Upon written notice to
Xxxxxx, Epimmune may elect to conduct further development of
any such Abandoned Product for any indication that is not
included in any launched Product or in any Product for which
Regulatory Approval applications have been submitted or in any
Product in development under the Development Plan and the
license granted to Xxxxxx by Epimmune in Section 6.1 shall
terminate with respect to any such Abandoned Product.
Notwithstanding the foregoing, an Abandoned Product shall not
be deemed to include any (i) back-up compound, the development
of which depends on the success of the lead compound, or (ii)
Product or compound, the development of which has been delayed
as part of the overall pipeline management strategy in order to
optimize the applicable technology platform.
-36- CONFIDENTIAL TREATMENT REQUESTED
17.2.5 If any failure to act diligently as required in Sections
17.2.1, 17.2.2, 17.2.3 and/or 17.2.4 is due to scientific
and/or technical results, clinical study problems outside of
Xxxxxx'x control, action by any Regulatory Authority or mutual
agreement of the parties, then the time periods for such
diligence requirements set forth therein shall be adjusted
accordingly.
17.3 EPIMMUNE DILIGENCE.
17.3.1 Xxxxxx may provide 90 days written notice to Epimmune if
Epimmune has failed to complete Research activities for which
it is responsible under the Research Plan, as amended from time
to time, within six (6) months following the date such activity
was scheduled for completion, in order for Epimmune to make
diligent and continuing efforts to rectify the situation during
such 90 day period. In the event that the parties are unable to
resolve their differences within such 90 day period, such
dispute shall be submitted for resolution to the senior
executive of each Party (i.e., the President of Epimmune and
the President of Xxxxxx R&D). If the senior executives are
unable to satisfactorily resolve such dispute within 30 days of
the date it was submitted to them, then the dispute shall be
submitted for binding arbitration in accordance with Section
19.12.
17.3.2 In the event, for the first Product [...***...] appropriate for
clinical trials which cover [...***...] has not occurred by
[...***...] then the amount due for the achievement of the
milestone event(s) provided in Item I.1. of Exhibit E shall be
reduced by [...***...] following such date that such [...***...
.] As of the [...***...] no payment shall be due Epimmune for
the achievement of the milestone event(s) provided in Item I.1.
of Exhibit E.
17.3.3 In the event, for the first Product under the [...***...]
appropriate for clinical trials which cover [...***...] has not
occurred by [...***...] then the amount due for the achievement
of the milestone event(s) provided in Item I.1. of Exhibit E
shall be reduced by [...***...] following such date that such
[...***....] As of the [...***...] no payment shall be due
Epimmune for the achievement of the milestone event(s) provided
in Item I.1. of Exhibit E.
-37- CONFIDENTIAL TREATMENT REQUESTED
17.3.4 If any failure to act diligently as required in Sections
17.3.1, 17.3.2 and 17.3.3 is due to scientific and/or technical
results, action by any Regulatory Authority or mutual agreement
of the parties, then the time periods for such diligence
requirements set forth therein shall be adjusted accordingly.
17.4 NEW OPPORTUNITIES. Following the [...***...] Epimmune may present ideas
for Products or technology not already contained in the Research Plan
or Development Plan(s) for inclusion in the Collaboration in reasonable
detail as is normally included in order to make a decision on compound
research within the pharmaceutical industry for consideration by Xxxxxx
(a "Proposal"). Xxxxxx shall consider any such Proposal in a timely
manner. If Xxxxxx determines in good faith that it is interested in
pursuing the Proposal under the Collaboration, the Parties will agree
on how to proceed with research and development of the Product or the
Development Plan. In the event that the Parties are unable to agree,
such dispute shall be submitted for resolution to the senior executive
of each Party (i.e., the President of Epimmune and the President of
Xxxxxx R&D). If the senior executives are unable to satisfactorily
resolve such dispute within 30 days of the date it was submitted to
them, then the dispute shall be submitted for binding arbitration in
accordance with Section 19.12. In the event Xxxxxx elects not to pursue
such Proposal under the Collaboration [...***...] upon written notice
to Xxxxxx, Epimmune may pursue the development of Products or
technology as described in the Proposal and the license granted to
Xxxxxx by Epimmune in Section 6.1 shall terminate solely with respect
to such Products or technology so rejected by Xxxxxx. For purposes of
this Section 17.4, a "Proposal" shall include a product concept for one
or more indications, with as much information as can be reasonably
determined about product specifications, and all relevant internal
data, relevant data from the literature, summary competitive analysis
and an overview at the target market(s).
ARTICLE 18. ASSIGNMENT.
------------------------
Neither this Agreement nor any of the rights or obligations hereunder may be
assigned by either Party without the prior written consent, which shall not be
unreasonably withheld, of the other Party, except to an Affiliate of the
assigning Party or to any Third Party who acquires all or substantially all of
the business of the assigning Party by merger, sale of assets or otherwise, so
long as such Affiliate or Third Party agrees in writing to be bound by the terms
of this Agreement. The assigning Party shall remain primarily liable hereunder
notwithstanding any such assignment.
-38- CONFIDENTIAL TREATMENT REQUESTED
ARTICLE 19. MISCELLANEOUS.
---------------------------
19.1 WAIVER. The failure by either Party to require performance by the other
Party of any of its obligations hereunder shall in no manner affect the
right of such Party to enforce the same at a later time. No waiver by
either Party of any condition, or of the breach of any provision of
this Agreement, whether by conduct or otherwise shall be deemed to be
or construed as a further or continuing waiver thereof.
19.2 AMENDMENTS. This Agreement may not be amended except in writing, signed
by both Parties.
19.3 SEVERABILITY. If any provision of this Agreement is held invalid or
unenforceable, such provision shall be deleted, and, if possible,
replaced by a provision which achieves the intent of the Parties.
19.4 RELATIONSHIP BETWEEN THE PARTIES. Nothing in this Agreement is intended
nor shall be construed to create a partnership or joint venture between
Epimmune and Xxxxxx. Neither Party shall have the express or implied
authority to assume or create any obligations on behalf of or in the
name of the other Party.
19.5 CORRESPONDENCE AND NOTICES. Extraordinary notices and communications
(including but not limited to notices of termination, force majeure,
material breach, change of address) shall be in writing and sent by
prepaid registered or certified air mail, or by facsimile confirmed by
prepaid registered or certified air mail letter, and shall be deemed to
have been properly served to the addressee upon receipt of such written
communication.
In the case of Epimmune, such address shall be:
Epimmune Inc.
0000 Xxxxx Xxxxx Xxxxx
Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: President
Fax: (000) 000-0000
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with a copy to:
Cooley Godward LLP
0000 Xxxxxxxxx Xxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxxxx X. Xxxx, Esq.
Tel: (000) 000-0000
Fax: (000) 000-0000
and in the case of Xxxxxx, such address shall be:
X. X. Xxxxxx & Xx.
X. X. Xxx 0000
Xxxxxxx, XX 00000-0000
Attn: Vice President, Business Development
Fax: (000) 000-0000
with a copy to:
Attn: General Counsel
Fax: (000) 000-0000
19.6 CHOICE OF LAW. This Agreement is subject to and governed by the laws of
Illinois (except the choice of laws rules thereof). The venue for any
legal proceedings shall be Illinois for legal proceedings brought by
Epimmune against Xxxxxx and California for legal proceedings brought by
Xxxxxx against Epimmune.
19.7 FORCE MAJEURE. Neither Party shall be liable to the other for delay or
failure in performing any of its obligations if and to the extent that
such failure or delay is due to circumstances beyond its control which
it could not have avoided by the exercise of reasonable diligence. It
shall notify the other Party promptly should such circumstances arise,
giving an indication of the likely extent and duration thereof, and
shall use all commercially reasonable efforts to resume performance of
its obligations as soon as practicable.
19.8 REGISTRATION AND FILING OF THE AGREEMENT. To the extent, if any, that a
Party concludes in good faith that it is required to file or register
this Agreement or a notification thereof with any governmental
authority, including without limitation the U.S. Securities and
Exchange Commission, the Competition Directorate of the Commission of
the European Communities or the U.S. Federal Trade Commission, in
accordance with applicable laws and regulations, such Party may do so,
and the other Party shall cooperate in such filing or notification and
shall execute all documents reasonably required in connection
therewith. In such situation, the Parties will request confidential
treatment of sensitive provisions of the Agreement, to the extent
permitted by law. The Parties shall promptly inform each other as to
the activities or inquiries of any such governmental authority relating
to this Agreement, and shall cooperate to respond to any request for
further information therefrom. Without limiting the foregoing, the
Parties agree to make all necessary filings required under the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements act of 1976, as amended, and
to cooperate with each other so as to comply therewith on a timely
basis in light of the provisions of this Agreement.
-40- CONFIDENTIAL TREATMENT REQUESTED
19.9 EXPORT. The Parties agree to abide by the export laws and regulations
of the United States and to cooperate with each other in obtaining any
required export license applicable to the subject matter of this
Agreement.
19.10 ENTIRE AGREEMENT. This Agreement together with its Exhibits and further
agreements mentioned herein constitutes the entire agreement of the
Parties with respect to the subject matter hereof as of its date, and
supersedes all prior agreements (including the Prior Agreements),
understandings, representations and proposals, written or oral,
relating thereto.
19.11 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original.
19.12 ARBITRATION. Any dispute arising under Section 1.26, 3.2.4 or Article
17 will be finally settled by arbitration in accordance with the then
existing Commercial Arbitration Rules of the American Arbitration
Association ("AAA"). Upon the written request of either party,
arbitration will be by one arbitrator with relevant experience in the
pharmaceutical industry selected within 30 days of such arbitration
request by mutual agreement of the Parties (or in accordance with AAA
rules if the Parties are unable to reach agreement on the selection of
such arbitrator). Judgment upon the award rendered by the panel, or
single arbitrator as the case may be, shall be final and nonappealable
and may be entered in any court having jurisdiction thereof. The
location for any arbitration initiated by either party shall be Dallas,
Texas, or at such other place as the parties may mutually agree.
[the remainder of this page intentionally left blank]
-41-
IN WITNESS WHEREOF, the parties have signed this Agreement effective as
of the year first set forth above.
X.X. XXXXXX & CO. EPIMMUNE INC.
By:/s/ X.X. Xx Xxxxxxxx By:/s/ Xxxxxxx Xxxxxxxx
-------------------- --------------------
R. U. Xx Xxxxxxxx Xxxxxxx Xxxxxxxx
Chairman and Chief Executive President
Officer and President
EXHIBITS
--------
A EPIMMUNE PATENT RIGHTS
B XXXXXX PATENT RIGHTS
C PRELIMINARY RESEARCH PLAN
D PRELIMINARY RESEARCH BUDGET
E MILESTONE PAYMENTS
-42-
EXHIBIT A
---------
EPIMMUNE PATENT RIGHTS
[...***...]
CONFIDENTIAL TREATMENT REQUESTED
-43-
EXHIBIT B
---------
XXXXXX PATENT RIGHTS
[...***...}
CONFIDENTIAL TREATMENT REQUESTED
-44-
EXHIBIT C
---------
PRELIMINARY RESEARCH PLAN
[...***...}
CONFIDENTIAL TREATMENT REQUESTED
-45-
EXHIBIT D
---------
PRELIMINARY RESEARCH BUDGET
-46-
EXHIBIT E
---------
MILESTONE PAYMENTS
For purposes of this Exhibit E, the following definitions shall apply:
(a) "First Product" means (i) for purposes of Articles I and II, the first
Product developed hereunder containing a [...***...] and (ii) for
purposes of Article III, the first Product developed hereunder
containing [...***....]
(b) "New Product" means any Product, whose composition (based on components
or formulation) is not identical to the First Product, for the
treatment of a specific type of cancer or cancers.
(c) "Additional Indication" means any indication, other than the specific
cancer(s) treated in the first indication of the First Product or of
any New Product. By way of illustration or example, if [...***...] is
the specific cancer treated as the first indication in either the First
Product or a New Product, then each of [...***...] shall be "Additional
Indications".
Subject to the provisos contained in Article IV of this Exhibit E, Xxxxxx shall
pay Epimmune the following amounts upon the occurrence of each of the following
milestone events with respect to each of [...***...]
I. [...***...]
-----------
1. Subject to sections 17.3.2 and 17.3.3 of the Agreement, [...***...]
upon the issuance of the first to occur of either (i) a single
Product Alert for a compound containing epitopes appropriate for
clinical trials which cover [...***...] for the treatment of
[...***...] or (ii) the last of separate Product Alerts for compounds
containing epitopes appropriate for clinical trials which cover,
[...***...] for the treatment of [...***...] or (iii) twelve (12)
months after selection of epitopes appropriate for clinical trials
which cover [...***...] for the treatment of [...***....]
2. [...***...] upon the start of Phase I/II clinical studies for (A) the
First Product, and (B) each New Product.
-47- CONFIDENTIAL TREATMENT REQUESTED
3. [...***...] upon (A) the completion of Phase II clinical studies for
the first indication of the First Product, where completion of such
studies shall be deemed to occur upon the determination by Xxxxxx
that the data resulting therefrom supports the start of Phase III
studies and no additional Phase II studies are required, and (B) the
start of Phase III clinical studies for the first indication of each
New Product.
4. [...***...] upon the start of Phase III clinical studies for each
Additional Indication of (A) the First Product and (B) each New
Product.
5. [...***...] upon the submission in the first of the Key Markets to
the Regulatory Authority of the application for Regulatory Approval
of the first indication of the (A) First Product and (B) each New
Product.
6. [...***...] upo
n the Launch Date in the first of the Key Markets of
the first indication of the (A) First Product and (B) each New
Product.
7. [...***...] upon the Launch Date in the first of the Key Markets of
each Additional Indication of (A) the First Product and (B) each New
Product.
II. [...***...]
-----------
1. [...***...] upon the issuance of the First Product Alert
[...***...]
2. [...***...] upon the start of Phase I/II clinical studies for
(A) the First Product, and (B) each New Product.
3. [...***...] upon the start of Phase III clinical studies for
the first indication of (A) the First Product, and (B) each New
Product.
4. [...***...] upon the start of Phase III clinical studies for
each Additional Indication of (A) the First Product and (B)
each New Product.
5. [...***...] upon the submission in the first of the Key Markets
to the Regulatory Authority of the application for Regulatory
Approval of the first indication of the (A) First Product and
(B) each New Product.
6. [...***...] upon the Launch Date in the first of the Key
Markets of the first indication of the (A) First Product and
(B) each New Product.
7. [...***...] upon the Launch Date in the first of the Key
Markets of each Additional Indication of (A) the First Product
and (B) each New Product.
-48- CONFIDENTIAL TREATMENT REQUESTED
III. [...***...]
-----------
1. [...***...] upon the issuance of a Product Alert satisfying the
Product specifications defined by Xxxxxx for the First Product.
2. [...***...] upon the start of Phase I/II clinical studies for
(A) the First Product, and (B) each New Product.
3. [...***...] upon the start of Phase III clinical studies for
the first indication of (A) the First Product, and (B) each New
Product.
4. [...***...] upon the start of Phase III clinical studies for
each Additional Indication of (A) the First Product, and (B)
each New Product.
5. [...***...] upon the submission in the first of the Key Markets
to the Regulatory Authority of the application for Regulatory
Approval of the first indication of (A) the First Product, and
(B) each New Product.
6. [...***...] upon the Launch Date in the first of the Key
Markets of the first indication of (A) the First Product, and
(B) each New Product.
7. [...***...] upon the Launch Date in the first of the Key
Markets of each Additional Indication of (A) the First Product,
and (B) each New Product.
IV. PROVISOS
--------
1. If, [...***...] a compound under Development fails and a back-up
compound is selected for Development in place thereof for the same
indications as the failed compound, then milestone payments will be
payable (upon the occurrence of the applicable triggering event) only
for those milestone events for which a payment was not previously
made with respect to the failed compound. For the avoidance of doubt,
no milestone payments shall be made for any back-up compound except
in the event a back-up compound replaces a lead compound in
Development.
2. It is the intention of the parties to begin Research and Development
of Products [...***...] then to [...***...] for pursuing Research and
Development of Products [...***...] If, for any technical, commercial
and/or strategic reasons, the parties agree to abandon Development of
Products within [...***...] in favor of the Research and Development
of Products within the [...***...] then, for any milestone events
achieved within the [...***...] which are for the same milestone
events (i.e. for the same indication) already achieved within the
[...***...] Xxxxxx shall pay Epimmune [...***...] of the amount
otherwise due for achievement of such [...***...] events provided
that this [...***...] cutback shall not apply to any Product Alert
milestone. For example, if the first three clinical milestone
payments have been made for the First Product developed within the
[...***...] prior to the abandonment of such platform, then Xxxxxx
shall pay Epimmune [...***...] of the first three clinical milestones
payments for the First Product developed within the [...***...].
-49- CONFIDENTIAL TREATMENT REQUESTED
3. Under Articles I, II and III above, the milestones stated are
milestones owed for the first achievement of a milestone event for
each Product indication without regard to the technology platform
under which such Product was developed. The milestones due upon each
subsequent achievement of a milestone event for the same indication
within the same technology platform for second generation Products or
within another technology platform shall be reduced by [...***...].
For example, the milestone payments would be [...***...] for the
start of Phase I/II clinical studies for a Product for the treatment
of [...***...] developed under the [...***...] and [...***...] for
the subsequent start of Phase I/II clinical studies for a Product for
the treatment of [...***...] developed under the [...***...] or a
second generation Product for the treatment of [...***...] developed
under the [...***...]
4. Payments made by Xxxxxx for milestone events achieved for [...***...]
Products under Article III shall in no event exceed [...***...] for
each such Product developed under this Agreement.
-50- CONFIDENTIAL TREATMENT REQUESTED
