SUBLICENSE AGREEMENT BY AND AMONG SEMACO, INC., A DELAWARE CORPORATION,Content License Agreement |
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EXHIBIT 10.1
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
SUBLICENSE AGREEMENT
BY AND AMONG
SEMACO, INC.,
A DELAWARE CORPORATION,
AND
BARBARA GILCHREST, M.D.,
AN INDIVIDUAL
AND
CANCERVAX CORPORATION,
A DELAWARE CORPORATION
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SUBLICENSE AGREEMENT
This Sublicense Agreement is entered into and made effective as of this
10th day of March, 2004 (the "Effective Date"), between SEMACO, Inc., a Delaware
corporation ("SEMACO") and Barbara Gilchrest, M.D., an individual ("Gilchrest"),
on the one hand, and CancerVax Corporation, a Delaware corporation
("CancerVax"), on the other hand.
RECITALS
A. Gilchrest, as Chair of the Boston University School of
Medicine, Department of Dermatology, has developed, together with certain
colleagues at Boston University, certain intellectual property rights relating
to telomere homolog oligonucleotides (also referred to as T-oligonucleotides, or
T-Oligos), and such intellectual property rights are owned by Boston University,
and have been licensed to, SEMACO pursuant to a license agreement between SEMACO
and Boston University.
B. SEMACO has the exclusive right to grant a sublicense to such
intellectual property rights, subject to said license agreement with Boston
University.
C. SEMACO desires to grant to CancerVax, and CancerVax wishes to
acquire, certain exclusive, worldwide rights and sublicenses to such
intellectual property rights and to certain patent rights, property rights and
know-how of SEMACO and Gilchrest with respect thereto, subject to the terms and
conditions set forth herein and to said license agreement with Boston
University.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and conditions
set forth herein, the parties hereby agree as follows:
1. Definitions. Capitalized terms shall have the meaning set
forth below.
1.1 Affiliate. The term "Affiliate" shall mean any entity
which directly or indirectly controls, is controlled by or is under common
control with CancerVax. The term "control" as used herein means the possession
of the power to direct or cause the direction of the management and the policies
of an entity, whether through the ownership of a majority of the outstanding
voting securities or by contract or otherwise.
1.2 Confidential Information. The term "Confidential
Information" shall mean any and all proprietary or confidential information of
SEMACO, Gilchrest or CancerVax which may be exchanged between the parties at any
time and from time to time during the term of this Agreement. Information shall
not be considered confidential to the extent that it:
1.2.1 Is publicly disclosed through no fault of
any party hereto, either before or after it becomes known to the receiving
party; or
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1.2.2 Was known to the receiving party prior to
the date of this Agreement, which knowledge was acquired independently and not
from another party hereto (or such party's employees); or
1.2.3 Is subsequently disclosed to the receiving
party in good faith by a third party who has a right to make such disclosure; or
1.2.4 Has been published by a third party as a
matter of right.
1.3 Field. The term "Field" shall mean the prevention,
treatment, control, prognosis or diagnosis of cancer; provided, however, that
the Field shall not include any product intended for use as a sunscreen or
sunless tanning aide, or for the treatment of skin damage (excluding Skin
Cancer, as such term is defined below) due to photoaging.
1.4 Intellectual Property Rights. The term "Intellectual
Property Rights" shall mean all intellectual property, including, without
limitation, inventions, patents and patent applications and all provisionals,
divisions, substitutes, continuations, continuations-in-part, re-examinations,
reissues, renewals, extensions, additions, corresponding foreign patents or
patent applications, and compositions of matter.
1.5 Licensed Know-How. The term "Licensed Know-How" shall
mean all data, information, know-how, technology, research results, methods of
use, manufacture, purification, testing and analysis developed and/or used by
SEMACO and/or Gilchrest in relation to the Licensed Technology.
1.6 Licensed Products. The term "Licensed Products" shall
mean any article, composition, apparatus, substance, chemical or any other
material for use in the Field that is covered by the Patent Rights or the
Property Rights, incorporates the Licensed Technology or the Licensed Know-How,
or that is discovered, derived or developed using the Licensed Technology, the
Licensed Know-How, the Patent Rights or the Property Rights.
1.7 Licensed Technology. The term "Licensed Technology"
shall mean T-Oligonucleotides, defined as single-stranded DNA fragments
(oligonucleotides) [***].
1.8 Net Sales. The term "Net Sales" shall mean [***].
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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1.9 Patent Rights. The term "Patent Rights" shall mean
all of SEMACO and Gilchrest's Intellectual Property Rights related to the
Licensed Technology, the Licensed Know-How, the Licensed Products or the
Property Rights including, without limitation, the patents and patent
applications listed on EXHIBITS A-1 AND A-2 attached hereto.
1.10 Phosphorothioate Backbone. The term "Phosphorothioate
Backbone" shall mean an oligonucleotide backbone that is a sulpher diester (as
compared to a normal phosphorous or phosphodiester bond), which is not easily
hydrolyzable.
1.11 Prior Patent Expenses. The term "Prior Patent
Expenses" shall have the meaning set forth in Section 5.3 of - this Agreement.
1.12 Property Rights. The term "Property Rights" shall
mean all of SEMACO and Gilchrest's property rights to the biological material
described as the T-Oligonucleotides, their derivatives, variations and
modifications, including any proteins, nucleic acids and/or biomolecules
produced and/or secreted by such materials; any antibodies directed against such
materials or their targets, and any agents bound or activated by such materials,
however acquired.
1.13 Skin Cancer. The term "Skin Cancer" shall mean any
disease where cancerous cells originate in the epidermal layer of the skin,
including without limitation, basal cell carcinoma, squamous cell carcinoma,
melanoma (including uveal and mucosal melanoma), or any other malignant skin
conditions.
1.14 University. The term "University" shall mean Trustees
of Boston University.
1.15 University License Agreement. The term "University
License Agreement" shall mean the License Agreement dated as of December 11,
2001, between SEMACO and the University, as amended from time to time.
2. Sublicense Terms and Conditions; Negative Covenants.
2.1 Grant of Sublicense. Subject to the terms of this
Agreement and the University License Agreement, SEMACO hereby grants to
CancerVax:
2.1.1 an exclusive, worldwide sublicense under the
Patent Rights and Licensed Know-How, including the right to grant sublicenses,
to make, have made, use, sell, offer to sell, export and import any Licensed
Products; and
2.1.2 an exclusive, worldwide sublicense and
bailment to possess the Property Rights and the Licensed Technology, including
the right to grant sublicenses and to transfer possession, to make, have made,
use, sell, offer to sell, export and import any Licensed Products.
2.2 For the avoidance of doubt, it is understood and
agreed by the Parties the Grant of Sublicense included in this Section 2.1 shall
not include any rights for CancerVax to make, have made, use, sell, offer to
sell, export and import any article, composition, apparatus,
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substance, chemical or any other material intended for use outside of the Field,
nor shall it prevent SEMACO or Gilchrest from using the Licensed Know-How, the
Patent Rights, Intellectual Property and Licensed Technology to develop any
article, composition, apparatus, substance, chemical or any other material
intended for use outside the Field.
3. Right of First Refusal.
3.1 SEMACO and Gilchrest each hereby grant to CancerVax a
right of first refusal to negotiate for the acquisition or licensing of
additional technology, Intellectual Property Rights and know-how developed or
currently owned or licensed by Gilchrest and/or SEMACO, in the Field and not
subject to the grant of Paragraph 2.1, and for any dermatologic use, including
any other diagnostic or therapeutic products for use in the Field.
Nothwithstanding the foregoing, this right of first refusal shall specifically
exclude any products intended for use to induce hair growth or coloration, or to
treat Alzheimer's Disease. Once CancerVax has declined or failed to timely
exercise its right of first refusal on any of the Intellectual Property Rights
covered under this Section 3.1, CancerVax shall not be entitled to a right of
first refusal on any subsequent continuation-in-part patent applications derived
from such declined Intellectual Property Rights where such continuations-in-part
applications does not include any subject matter that is within the Field.
3.2 SEMACO shall provide CancerVax with written notice of
any such new technology, or Intellectual Property Rights. CancerVax will have
thirty (30) days to express its interest in negotiating with SEMACO for such
rights. CancerVax shall be entitled to negotiate with SEMACO for a period of
ninety (90) days following SEMACO's receipt of any such notice of interest from
CancerVax.
3.3 Notwithstanding the foregoing, for any technology,
Intellectual Property Rights or know-how licensed to SEMACO under the University
License Agreement as of the Effective Date, CancerVax will have sixty (60) days
from the Effective Date to express its interest in negotiating with SEMACO for
such rights; provided, however, that, prior to the Effective Date, SEMACO shall
have provided CancerVax with the relevant patent numbers, in the case of issued
patents, or with a copy of all such patent applications or invention
disclosures, in the case of technology, Intellectual Property Rights or know-how
not covered by issued patents. CancerVax shall be entitled to negotiate with
SEMACO for a period of ninety (90) days following SEMACO's receipt of any such
notice of interest from CancerVax.
4. Consideration. SEMACO shall receive from CancerVax the
following consideration in relation to the rights and sublicenses granted to
CancerVax under this Agreement:
4.1 Milestones. CancerVax shall pay the milestone
payments set forth on EXHIBIT B to SEMACO upon the occurrence of each event
specified. Payment of the milestones shall be due within thirty (30) days of the
achievement of each event.
4.2 Research Support.
4.2.1 CancerVax shall pay [***] per calendar
quarter in advance to SEMACO for a period of three (3) years, commencing on the
Effective Date, for support of
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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research directly related to the Licensed Technology, based upon a research and
Research Program to be mutually agreed upon between SEMACO and CancerVax within
sixty (60) days following the Effective Date (the "Research Program"). The
Research Program shall be performed by the University under the direction of
Gilchrest as Chair of the Boston University School of Medicine, Department of
Dermatology, pursuant to a sponsored research agreement between the University
and SEMACO. The sponsored research agreement shall be executed within sixty (60)
days following the Effective Date, and shall be subject to prior review and
approval by CancerVax.
4.2.2 Subject to the University's policies and
such conditions as the University may reasonably impose, SEMACO shall permit an
employee or consultant of CancerVax to work with SEMACO in SEMACO's facilities
on a full-time basis for purposes of ensuring the transfer to CancerVax of
technology developed by SEMACO in the furtherance of the Research Program. Such
employee or consultant shall be reasonably acceptable to SEMACO. SEMACO shall
have the right to request CancerVax to replace such employee or consultant if
SEMACO determines, in its sole discretion, that such employee or consultant
materially violates any of the rules, regulations or policies of SEMACO or the
University. CancerVax shall be and shall remain fully responsible for such
employee or consultant and shall indemnify, defend and hold SEMACO and the
University and their trustees, officers, directors, employees, agents and
affiliates harmless from and against any and all acts or omissions of such
employee or consultant.
4.3 Consulting Agreement.
4.3.1 As consideration for entering into a three
(3)-year consulting agreement with CancerVax, CancerVax shall pay a consulting
fee at an annualized rate of [***] per twelve-month period to Gilchrest, payable
in advance in equal monthly installments, beginning on the Effective Date, plus
reasonable travel expenses approved by CancerVax.
4.3.2 Subject to the approval of the board of
directors of CancerVax, Gilchrest shall be granted options to purchase [***]
shares of CancerVax common stock in accordance with CancerVax's 2003 Equity
Incentive Plan. One-third (1/3) of such options would vest after one (1) year,
with the balance vesting monthly over the next two (2) years of service to
CancerVax.
4.4 Royalties.
4.4.1 Percentage Royalty. Subject to the terms and
conditions of this Agreement, CancerVax shall pay to SEMACO a royalty based on
the Net Sales of all Licensed Products, as follows:
(a) [***] of Net Sales of the Licensed
Products that are less than or equal to [***];
(b) [***] of Net Sales of the Licensed
Products that are greater than [***] but less than [***]; and
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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(c) [***] of Net Sales of the Licensed
Products that are equal to or greater than [***].
4.4.2 Royalties on Sublicenses. If CancerVax
receives a royalty or milestone payment from a third party (other than an
Affiliate of CancerVax) in relation to any sublicense agreement for the Licensed
Products or the sale of the Licensed Products, CancerVax shall pay to SEMACO the
following payments (in each case excluding, however, any research or development
support, equity or other non-monetary payments), within forty-five (45) days of
its receipt of such payment:
(a) [***] of any such royalty or
milestone payment received by CancerVax if CancerVax enters into a sublicense
agreement with respect to the Licensed Products prior to the filing of an IND;
(b) [***] of any such royalty or
milestone payment received by CancerVax if CancerVax enters into a sublicense
agreement with respect to the Licensed Products after filing an IND but prior to
the completion of a Phase I/II clinical trial; or
(c) if clauses (a) or (b) above are not
applicable, [***] of any such royalty or milestone payment received by
CancerVax.
(d) Set-Off. In the event that
CancerVax must pay royalties or other payments to any third party in relation to
the sale of the Licensed Products based upon rights dominating those of SEMACO,
the royalty payable to SEMACO shall be reduced by the amount of any such third
party payment. CancerVax shall promptly notify SEMACO, in writing, of any such
claim and shall consult with SEMACO to determine the validity of the claim and
the amount of any royalties or payments that should be paid to any third party.
4.5 Quarterly Payments.
4.5.1 Sales by CancerVax. With regard to Net Sales
made by CancerVax or its Affiliates, royalties shall be payable by CancerVax
quarterly, within forty-five (45) days after the end of each calendar quarter,
based upon the Net Sales of Licensed Products during such preceding calendar
quarter, commencing with the calendar quarter in which the first commercial sale
of any Licensed Product is made.
4.5.2 Sales by Sublicensees. With regard to Net
Sales made by sublicensees of CancerVax or its Affiliates, royalties shall be
payable by CancerVax quarterly, within sixty (60) days after the end of each
calendar quarter, based upon the Net Sales of Licensed Products by such
sublicensee during such preceding calendar quarter, commencing with the calendar
quarter in which the first commercial sale of any Licensed Product is made by
such sublicensee.
4.6 Duration of Royalty Obligations. The royalty
obligations of CancerVax as to each Licensed Product shall terminate on a
country-by-country basis concurrently with the expiration of the last to expire
of any claim of the Patent Rights utilized by or in such Licensed Product in
each such country or, with respect to Licensed Products not utilizing any Patent
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the Commission. Confidential treatment has been requested with respect to the
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Rights, fifteen (15) years after the date of first commercial sale of such
Licensed Product in such country.
4.7 Reports. CancerVax will furnish to SEMACO a detailed
written report of Net Sales of the Licensed Products and the royalty due and
payable thereon, including a description of any offsets or credits deducted
therefrom, on a product-by-product and country-by-country basis, for the
calendar quarter upon which the royalty payment is based.
4.8 Records. CancerVax will keep, and cause its
Affiliates and sublicensees to keep, full, complete and proper records and
accounts of all sales of Licensed Products in sufficient detail to enable the
royalties payable on Net Sales of each Licensed Product to be determined. SEMACO
shall have the right to appoint an independent certified public accounting firm
approved by CancerVax, which approval shall not be unreasonably withheld,
conditioned or delayed to audit the records of CancerVax, its Affiliates and
sublicensees as necessary to verify the royalties payable pursuant to this
Agreement. Any auditing firm appointed by SEMACO shall execute a confidentiality
agreement with CancerVax prior to performing such audit. CancerVax, its
Affiliates and sublicensees will pay to SEMACO an amount equal to any additional
royalties to which SEMACO is entitled as disclosed by the audit, plus interest
thereon at the rate of six percent (6%) per annum. Such audit shall be at
SEMACO's expense; provided, however, that if the audit discloses that SEMACO was
underpaid royalties with respect to any Licensed Product by at least five
percent (5%) for any calendar quarter, then CancerVax, its Affiliates or
sublicensee, as the case may be, will reimburse SEMACO for any such audit costs,
plus interest thereon at the rate of six percent (6%) per annum. SEMACO may
exercise its right of audit as to each of CancerVax, its Affiliates or
sublicensees no more frequently than once in any calendar year, unless an audit
has revealed underpayments of five percent (5%) or more in which case SEMACO
shall be entitled to conduct such audits no more frequently than once in any
three-month period, upon ten (10) days prior written notice. . The accounting
firm shall disclose to SEMACO only information relating to the accuracy of the
royalty payments. CancerVax, its Affiliates and sublicensees will preserve and
maintain all such records required for audit for a period of six (6) years after
the calendar quarter to which the record applies.
4.9 Foreign Sales. The remittance of royalties payable on
sales outside the United States shall be payable to SEMACO in United States
Dollar equivalents at the official rate of exchange of the currency of the
country from which the royalties are payable, as quoted in the Wall Street
Journal for the last business day of the calendar quarter in which the royalties
are payable. If the transfer of or the conversion into the United States Dollar
equivalents of any such remittance in any such instance is not lawful or
possible, the payment of such part of the royalties as is necessary shall be
made by the deposit thereof, in the currency of the country where the sale was
made on which the royalty was based to the credit and account of SEMACO or its
nominee in any commercial bank or trust company of SEMACO'S choice located in
that country, written notice of which shall be given by CancerVax to SEMACO.
4.10 Foreign Taxes. Any tax required to be withheld by
CancerVax under the laws of any foreign country for the accounts of SEMACO will
be paid by CancerVax for and on behalf of SEMACO to the appropriate governmental
authority, and CancerVax will furnish SEMACO with proof of payment of such tax
together with official or other appropriate evidence issued by the applicable
government authority. Any such tax actually paid on SEMACO'S
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behalf shall be deducted from royalty payments due SEMACO. SEMACO and CancerVax
agree to cooperate with each other to claim any exemptions for such deductions
or withholdings under any agreement or treaty from time to time in effect.
4.11 Late Payments. Any late sublicense, research support,
consultant, milestone, royalty or other payments shall bear interest at the rate
of six percent (6%) per annum. Nothing herein is intended or shall be construed
to preclude SEMACO or Gilchrest from exercising any other rights or remedies it
may otherwise have in the event of CancerVax's failure to timely make the
payments due hereunder.
5. Patent Matters.
5.1 Patent Prosecution and Maintenance. From and after
the date of this Agreement, the provisions of this Section 5 shall control the
prosecution and maintenance of any patent included within the Patent Rights.
Subject to the requirements, limitations and conditions set forth in this
Agreement, SEMACO shall direct and control (i) the preparation, filing and
prosecution of the United States and foreign patent applications within the
Patent Rights (including any interferences and foreign oppositions) and (ii)
maintain the patents issuing therefrom. SEMACO shall select the patent attorney,
subject to CancerVax's written approval, which approval shall not be
unreasonably withheld, conditioned or delayed. CancerVax shall have full rights
of prior consultation with the patent attorney so selected on all matters
relating to SEMACO Patent Rights. SEMACO shall use its best efforts to implement
all reasonable requests made by CancerVax with regard to the preparation,
filing, prosecution and/or maintenance of the patent applications and/or patents
within the Patent Rights.
5.2 Information to CancerVax. SEMACO shall keep CancerVax
informed with regard to the patent application and maintenance processes. SEMACO
shall deliver to CancerVax copies of all patent applications and amendments at
least thirty (30) days prior to the filing thereof, unless the Parties agree in
writing, on a case-by-case basis, to a shorter period, as well as copies of all
related correspondence and other related matters.
5.3 Patent Costs. CancerVax acknowledges and agrees that
the sublicenses granted hereunder are in part in consideration for CancerVax's
assumption of patent costs and expenses as described herein, including all
reasonable actual prior maintenance and prosecution costs as of the Effective
Date (the "Prior Patent Expenses"), the total of which is [***] In addition,
CancerVax will pay for all patent expenses incurred by SEMACO pursuant to
Section 5.1 hereof. CancerVax agrees to pay all such past and future patent
expenses directly or to reimburse SEMACO for the payment of such expenses within
sixty (60) days after CancerVax receives an acceptable itemized invoice
therefore. In the event CancerVax elects to discontinue payment for the filing,
prosecution and/or maintenance of any patent application and/or patent within
the Patent Rights, any such patent application or patent shall be excluded from
the definition of the Patent Rights and from the scope of the license granted
under this Agreement, and all rights relating thereto shall revert to SEMACO.
CancerVax will give SEMACO at least thirty (30) days' prior written notice of
such election. No such notice shall have any effect on CancerVax's obligations
to pay expenses incurred up to the effective date of such election.
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5.4 Ownership. It is anticipated that the parties and the
University may develop and/or acquire technology or inventions in connection
with the Research Program relating to the Licensed Products. In the event such
technology or inventions result from the joint activities of CancerVax and the
University and/or SEMACO ("Joint Improvements"), such Joint Improvements shall
be jointly owned by CancerVax and the University and/or SEMACO and shall be
considered part and parcel of the Patent Rights, Property Rights, Licensed
Technology and/or Licensed Know-How (as applicable) under the terms of this
Agreement. Such technology or inventions which are solely the result of
activities of the University and/or SEMACO, or their employees or consultants,
by internal development, acquisition or licensing, and any patent or other
Intellectual Property Rights resulting therefrom, shall be solely the property
of the University and/or SEMACO ("SEMACO Improvements"); provided, however, that
all SEMACO Improvements shall be considered part and parcel of the Patent
Rights, Property Rights, Licensed Technology and/or Licensed Know-How (as
applicable) under the terms of this Agreement. Such technology or inventions
which are solely the result of activities of CancerVax's employees, consultants
or Affiliates, by internal development, acquisition or licensing, and any patent
or other Intellectual Property Rights resulting therefrom, shall be the sole
property of CancerVax.
5.5 SEMACO Right to Pursue Patent. If at any time during
the term of this Agreement, CancerVax's rights with respect to the Patent Rights
are terminated, SEMACO shall have the right to take whatever action SEMACO deems
appropriate to obtain or maintain the corresponding patent protection at its own
expense. If SEMACO pursues patents under this Section 5.5, CancerVax agrees to
cooperate fully, including by providing, at no charge to SEMACO, all appropriate
technical data and executing all necessary legal documents.
5.6 Infringement Actions.
5.6.1 Notification of Infringement. In the event a
party to this Agreement acquires information that a third party is infringing
the Patent Rights, the Property Rights, the Licensed Technology and/or the
Licensed Know-How, the party acquiring such information shall promptly notify
the other parties to the Agreement in writing of such infringement.
5.6.2 Enforcement of Infringement Actions.
(a) CancerVax will have the first
right, but not the obligation, to institute, prosecute and control, at its own
expense, any action or proceeding with respect to infringement or
misappropriation of the Patent Rights, the Property Rights, the Licensed
Technology and/or the Licensed Know-How, by counsel of its own choice, and will
consult with SEMACO and the University on any actions that CancerVax proposes to
take in such action or proceeding. SEMACO and the University will have the
right, at their own expense, to be jointly represented in any such action by
counsel of their own choice.
(b) If CancerVax fails to bring an
action or proceeding or otherwise take appropriate action in CancerVax's
discretion to abate such infringement or misappropriation within a period of
ninety (90) days of written notice by SEMACO or the University to CancerVax
requesting such action, SEMACO and the University will each have the
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right, but not the obligation, to bring and control, by counsel of its own
choice, any such infringement or misappropriation action or proceeding;
provided, however, that neither SEMACO nor the University will be entitled to
bring any such action or proceeding if CancerVax reasonably objects thereto on
the grounds that such action or proceeding could threaten the validity or
enforceability of the Patent Rights, the Property Rights, the Licensed
Technology or the Licensed Know-How. CancerVax will cooperate with SEMACO and
the University in any such action or proceeding brought by SEMACO and/or the
University against a third party, and will have the right to consult with SEMACO
and the University and to participate in and be represented by independent
counsel in such litigation at its own expense.
(c) If a party brings any action or
proceeding under this Section 5.6.2, the other parties agree, at the request and
expense of the first party, to be joined as a party plaintiff to the extent
necessary to prosecute the action or proceeding and to give the first party
reasonable assistance and authority to file and prosecute the suit, including
reasonable access to the inventors and records related to such action whic






