EXHIBIT 10.1
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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
XXXXXXX XXXXXXXXX, M.D.,
AN INDIVIDUAL
AND
CANCERVAX CORPORATION,
A DELAWARE CORPORATION
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 Xxxxxxx Xxxxxxxxx, M.D., an individual ("Xxxxxxxxx"),
on the one hand, and CancerVax Corporation, a Delaware corporation
("CancerVax"), on the other hand.
RECITALS
X. Xxxxxxxxx, 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 Xxxxxxxxx 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, Xxxxxxxxx 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 Xxxxxxxxx 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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1.9 Patent Rights. The term "Patent Rights" shall mean
all of SEMACO and Xxxxxxxxx'x 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 Xxxxxxxxx'x 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 Xxxxxxxxx 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 Xxxxxxxxx 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 Xxxxxxxxx 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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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
Xxxxxxxxx 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 Xxxxxxxxx, 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, Xxxxxxxxx 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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(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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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 Xxxxxxxxx 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 XXXXXX xxxxx
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 xxxxx 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 which are
under the control of such other party.
(d) The party that controls the
prosecution of a given action under this Section 5.6.2 will also have the right
to control settlement of such action; provided, however, that no settlement will
be entered into concerning or affecting the validity or enforceability of the
Patent Rights, the Property Rights, the Licensed Technology or the Licensed
Know-How or any other rights of the other parties or the University without the
written consent of the other parties and the University.
(e) Each party will bear its own costs
incurred in connection with an action or proceeding brought by a party pursuant
to this Section 5.6.2. In the case of an action or proceeding initiated by
CancerVax, CancerVax shall be entitled to retain the balance of the remainder of
such recovery, after reimbursement of SEMACO's or the University's expenses. In
the case of an action or proceeding initiated by SEMACO or the University,
SEMACO or the University shall be entitled to retain the balance of the
remainder of such recovery, after reimbursement of CancerVax's expenses.
5.6.3 Defense of Infringement Actions.
(a) If a third party asserts that a
patent, trade secret or other intangible right owned or exclusively licensed by
it is infringed or misappropriated by the manufacture, use, sale, offer for
sale, exportation or importation of any Licensed Product, CancerVax will
establish a plan for a common defense and manage such common defense plan,
subject to Section 5.6.3(b) below. Except as provided in Section 5.6.3(b), each
party will bear its own costs incurred in connection with any such defense, and
SEMACO and Xxxxxxxxx will give CancerVax reasonable assistance and authority to
defend, including reasonable access to the inventors and records relating to
such action which are under the control of SEMACO and/or Xxxxxxxxx.
(b) CancerVax will control settlement
of any claim described in Section 5.6.3(a) above; provided, however, that no
settlement will be entered into concerning or affecting the validity or
enforceability of the Patent Rights, the Property Rights, the Licensed
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Technology or the Licensed Know-How without the written consent of SEMACO and
the University, which consent shall not be unreasonably withheld. CancerVax will
be responsible for the payment of amounts owed in settlement or for damages in
respect of any claim described in Section 5.6.3(a) above, although any such
amounts resulting from a claim of infringement or misappropriation by the
manufacture, use, sale, offer for sale, exportation or importation of a Licensed
Product will be treated as third party payments for purposes of (and thus
subject to offset as contemplated by) Section 4.4.3 above.
6. Responsibilities of CancerVax.
6.1 In order to maintain the rights and sublicenses
granted hereunder in force, CancerVax will use commercially reasonable efforts
to perform the responsibilities set forth on EXHIBIT C.
6.2 CancerVax will keep SEMACO generally informed as to
CancerVax's progress in such development and commercialization, including its
efforts, if any, to sublicense the Licensed Technology or the Patent Rights.
CancerVax will deliver to SEMACO (i) a progress report every six (6) months for
the first two (2) years following the Effective Date of this Agreement and (ii)
thereafter, an annual written report and such other reports as SEMACO may
reasonably request. In addition, CancerVax shall provide SEMACO and Xxxxxxxxx
with such information as they may reasonably request from time to time relative
to the development or commercialization of the Licensed Technology or the Patent
Rights.
6.3 In the event SEMACO has a reasonable basis to believe
that CancerVax is not using commercially reasonable efforts to perform its
obligations as required under this Section 6, upon notice by SEMACO to CancerVax
which specifies the basis for such belief, SEMACO and CancerVax shall negotiate
in good faith to attempt to mutually resolve the issue. In the event SEMACO and
CancerVax cannot agree upon any matter related to CancerVax's obligations, the
parties agree to utilize arbitration pursuant to Section 14.2 hereof in order to
resolve the matter. If the arbitrator determines that CancerVax has not complied
with its obligations hereunder, and such default is not fully cured within sixty
(60) days after the arbitrator's decision, SEMACO may terminate CancerVax's
rights under this Agreement.
7. Responsibilities of SEMACO and Xxxxxxxxx.
7.1 SEMACO and Xxxxxxxxx each will use commercially
reasonable efforts to perform the responsibilities set forth on EXHIBIT D.
7.2 SEMACO will keep CancerVax generally informed as to
SEMACO's progress in the performance of the responsibilities set forth in
EXHIBIT D. SEMACO will deliver to CancerVax (i) a progress report every six (6)
months for the first two (2) years following the Effective Date of this
Agreement and (ii) thereafter, an annual written report and such other reports
as CancerVax may reasonably request.
7.3 In the event CancerVax has a reasonable basis to
believe that SEMACO or Xxxxxxxxx is not using commercially reasonable efforts to
perform its respective obligations as required under this Section 7, upon notice
by CancerVax to SEMACO and/or Xxxxxxxxx which specifies the basis for such
belief, CancerVax and SEMACO shall negotiate in good faith to
11
attempt to mutually resolve the issue. In the event CancerVax and SEMACO cannot
agree upon any matter related to SEMACO's and/or Xxxxxxxxx'x obligations, the
parties agree to utilize arbitration pursuant to Section 14.2 hereof in order to
resolve the matter. If the arbitrator determines that SEMACO or Xxxxxxxxx has
not complied with its obligations hereunder, and such default is not fully cured
within sixty (60) days after the arbitrator's decision, CancerVax may, at its
option, terminate this Agreement.
8. Indemnity.
8.1.1 CancerVax hereby agrees to indemnify, defend
and hold harmless Xxxxxxxxx and SEMACO, the University, and any parent,
subsidiary or other affiliated entity and their trustees, officers, employees,
scientists and agents (each an "Indemnitee") from and against any liability or
expense arising from any product liability claim asserted by any party as to any
Licensed Product or Licensed Technology, or any claims arising from a breach by
CancerVax of any of its obligations under this Agreement.
8.1.2 With respect to an Indemnitee, CancerVax's
indemnification obligations under this Section 8 shall not apply to any
liability, damage, loss or expense if such liability, damage or expense is
attributable to the gross negligence or willful misconduct of such Indemnitee.
9. Patent Marking. To the extent required by applicable law,
CancerVax shall xxxx all Licensed Products or their containers in accordance
with the applicable patent marking laws.
10. Representations and Warranties.
10.1 By CancerVax. CancerVax hereby represents and
warrants to SEMACO as follows:
10.1.1 CancerVax is a corporation duly organized,
validly existing and in good standing under the laws of Delaware.
10.1.2 The execution, delivery and performance of
this Agreement have been duly authorized by the Board of Directors of CancerVax.
10.1.3 This Agreement is a legal and valid
obligation binding upon CancerVax and enforceable in accordance with its terms,
and the execution, delivery and performance of the Agreement by CancerVax does
not conflict with any agreement, instrument or understanding, oral or written,
to which CancerVax is a party or by which it is bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
12
10.2 By SEMACO.
10.2.1 SEMACO is a corporation duly organized,
validly existing and in good standing under the laws of Delaware.
10.2.2 The execution, delivery and performance of
this Agreement have been duly authorized by the Board of Directors of SEMACO.
10.2.3 This Agreement is a legal and valid
obligation binding upon SEMACO and enforceable in accordance with its terms, and
the execution, delivery and performance of the Agreement by SEMACO does not
conflict with any agreement, instrument or understanding, oral or written, to
which SEMACO is a party or by which it is bound, nor, to the best of SEMACO's
knowledge, violates any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it.
10.2.4 SEMACO has not granted, and during the term
of the Agreement will not grant, any right to any third party relating to the
Patent Rights, the Property Rights, the Licensed Technology or the Licensed
Know-How that would conflict with the rights granted to CancerVax under this
Agreement. To the best of SEMACO's knowledge, the University and/or SEMACO has
good and valid title to the Patent Rights, the Property Rights, the Licensed
Technology and the Licensed Know-How, free and clear of any encumbrance, lien,
mortgage, charge, restriction or liability of any kind whatsoever, whether
equitable or legal, that would conflict with the rights granted to CancerVax
under this Agreement.
10.2.5 Subject to the terms of the University
License Agreement, SEMACO has the right to grant to CancerVax the rights and
sublicenses in and to the Patent Rights, the Property Rights, the Licensed
Technology and the Licensed Know-How set forth in this Agreement.
10.2.6 To the best of SEMACO's knowledge, as of the
Effective Date, the assignment of Xxxxxxxxx'x and all inventors and/or
co-inventors' rights to each Licensed Patent has been properly recorded with the
U.S. Patent and Trademark Office ("PTO").
10.2.7 To the best of SEMACO's knowledge, in the
instance of each patent application included within the Patent Rights, such
patent application has been properly prepared and filed and has been diligently
pursued through the Effective Date.
10.2.8 To the best of SEMACO's knowledge, as of the
Effective Date, there has been no publication related to, or public use of, the
Patent Rights, the Property Rights, the Licensed Technology or the Licensed
Know-How, that would reasonably form the basis for invalidating any claim in any
of the Patent Rights.
10.2.9 There is no action or proceeding pending or,
to the best of SEMACO's knowledge, threatened that relates to, affects or arises
in connection with (i) any of the Patent Rights, Property Rights, Licensed
Technology and/or Licensed Know-How, (ii) any Licensed Product or (iii) SEMACO's
performance under this Agreement; and SEMACO is not subject to any order, ruling
or judgment of any governmental or regulatory authority that could
13
reasonably be expected to impair or delay the ability of SEMACO to perform its
obligations under this Agreement.
10.2.10 SEMACO has not received any demand from any
other party for the licensing of any Intellectual Property Rights of such party
arising out of the development, manufacture or commercialization of the Patent
Rights, Property Rights, Licensed Technology, Licensed Know-How and/or Licensed
Products, and to the best of SEMACO's knowledge no basis exists for any such
claim or demand.
10.2.11 SEMACO has provided CancerVax with a
complete and accurate copy of the University License Agreement, all amendments
or modifications thereto, as of the Effective Date. The License Agreement is a
legal and valid obligation binding upon SEMACO, and is in full force and effect
and has not been amended or restated. No default or material breach exists under
the License Agreement. SEMACO agrees that it shall not agree to any amendment or
modification to the University License Agreement during the term of this
Agreement without obtaining the prior written approval of such amendment or
modification from CancerVax, which approval shall not be unreasonably, withheld,
conditioned or delayed.
10.2.12 The Patent Rights, the Intellectual Property
Rights, the Licensed Know-How, the Licensed Technology and the Licensed Products
are not subject to the "Xxxx-Xxxx Act", 35 U.S.C. 200 et seq. as of the
Effective Date. SEMACO agrees that, during the term of this Agreement, it shall
not take any action which would give rise to any governmental rights in any of
the Intellectual Property Rights, the Licensed Know-How, the Licensed Technology
and the Licensed Products under the "Xxxx-Xxxx Act" without obtaining the prior
written approval of CancerVax.
10.3 By Xxxxxxxxx. This Agreement is a legal and valid
obligation binding upon Xxxxxxxxx and enforceable in accordance with its terms,
and the execution, delivery and performance of the Agreement by Xxxxxxxxx does
not conflict with any agreement, instrument or understanding, oral or written,
to which Xxxxxxxxx is a party or by which she is bound, nor to her best
knowledge violate any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over her.
10.4 Limitation of Warranties. EXCEPT AS EXPRESSLY STATED
IN THIS AGREEMENT, THE PARTIES MAKE NO OTHER WARRANTIES CONCERNING THIS
AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO THE PATENT RIGHTS,
PROPERTY RIGHTS, LICENSED TECHNOLOGY, LICENSED KNOW-HOW OR ANY LICENSED PRODUCT.
11. Confidentiality and Publication.
11.1 Treatment of Confidential Information. Except as set
forth below, the parties agree that during the term of this Agreement, and for a
period of ten (10) years after this Agreement terminates, a party receiving
Confidential Information of any party will (i) maintain in confidence such
Confidential Information to the same extent such party maintains its own
proprietary industrial information, (ii) not disclose such Confidential
Information to any third
14
party without prior written consent of such party and (iii) not use such
Confidential Information for any purpose except those permitted by this
Agreement. Notwithstanding the foregoing, SEMACO and Xxxxxxxxx may disclose
Confidential Information to the University as necessary or appropriate in
connection with the matters related to the University License Agreement and
sponsored research agreement with the University, provided that such disclosures
are made to the University pursuant to a form of nondisclosure agreement
reasonably acceptable to CancerVax, which shall not be unreasonably withheld,
conditioned or delayed.
11.2 Permitted Disclosures. Notwithstanding the provisions
of Section 11.1, a party may not disclose the terms of this Agreement to any
third party without the prior written consent of the other parties; provided,
however, that any party may disclose the terms of this Agreement (i) to its
Affiliates, sublicensees, accountants, attorneys and other professional
advisors, and to the University, (ii) to third parties who need to know the same
in order to secure regulatory approval for the sale of the Licensed Products and
(iii) as required by applicable laws and regulations of the U.S. Securities and
Exchange Commission, any stock exchange on which a party's stock is traded and
any inter-dealer quotation system on which trading information for a party's
stock is quoted. As part of any filing of this Agreement pursuant to the
foregoing clause (iii), the filing party will provide the other parties with the
opportunity to review and comment on proposed redactions to this Agreement for
purposes of such filing (although the filing party will have no obligation in
the event that such redactions are not made or accepted as part of such filing).
11.3 Publications. Except for permitted disclosures as set
forth in Section 11.2, SEMACO and Xxxxxxxxx may not present or publish,
including, without limitation, any abstracts, posters, articles and oral or
written presentations, relating to any information or research results that have
not been published or publicly presented as of the Effective Date arising from
this Agreement, including, without limitation, any information or research
results which relate to the use of the Patent Rights, Property Rights, Licensed
Technology, Licensed Know-How or Licensed Products, whether in a thesis,
scientific publication, conference or otherwise, without first presenting the
same to CancerVax for its review. SEMACO shall use its best efforts to provide
intended presentations or publications in writing to CancerVax for review and
comment at least ten (10) working days prior to the earlier of (i) the date of
publication or (2) the time which the presentation or publication is proposed
for submission to any third party. CancerVax will provide notice to SEMACO
and/or Xxxxxxxxx whether it has any comments or objection to the proposed
presentation or publication in a timely manner. If CancerVax believes that a
patent application should be filed as a result of its review of a proposed
presentation or publication, then, upon timely written notice to SEMACO,
submission of the presentation or publication will be delayed in order to permit
CancerVax a reasonable period of time to file a patent application thereon. Each
party may be acknowledged on any publication or presentation in accordance with
generally accepted rules of authorship. CancerVax likewise agrees to first
present any intended presentations or publications regarding research results
which relate to the use of the Patent Rights, Property Rights, Licensed
Technology, Licensed Know-How or Licensed Products, to SEMACO for its review and
comment prior to presentation or publication in a scientific publication or
scientific conference.
11.4 Publicity. Except as otherwise provided herein or
required by law, no party shall originate any publication, news release or other
public announcement, written or oral,
15
whether in the public press, stockholders' reports, or otherwise, relating to
this Agreement or to any sublicenses hereunder, or to the performance hereunder
or any such agreements, without the prior written approval of the other party,
which approval shall not be unreasonably withheld or delayed. Notwithstanding
the foregoing, any press release related to this Agreement will be provided to
SEMACO for its review and approval, which approval shall not be unreasonably
withheld, not less than three (3) days in advance of its public release.
Further, except as otherwise provided herein or required by law, CancerVax shall
not use the name of the University without the prior written approval of the
University.
12. Term and Termination.
12.1 Term. Unless terminated sooner in accordance with the
terms set forth herein, this Agreement, and the sublicenses granted hereunder,
shall terminate when the last of the royalty obligations set forth in Section
4.6 has expired. Notwithstanding the foregoing, if applicable government
regulations require a shorter term and/or a shorter term of exclusivity than
provided for herein, then the term of this Agreement shall be so shortened or
this Agreement shall be amended to provide for non-exclusive sublicenses, and,
in such event, the parties shall negotiate in good faith to reduce appropriately
the royalties payable as set forth under Section 4 hereof.
12.2 Termination Upon Default. Any one or more of the
following events shall constitute an event of default hereunder: (i) the failure
of a party to pay any amounts when due hereunder and the expiration of thirty
(30) days after receipt of a written notice requesting the payment of such
amount; and (ii) the failure of a party to perform any obligation required of it
to be performed hereunder, and the failure to cure within sixty (60) days after
receipt of notice from another party specifying in reasonable detail the nature
of such default. Upon the occurrence of any event of default, the non-defaulting
party shall deliver to the defaulting party written notice of intent to
terminate, such termination to be effective upon the date set forth in such
notice.
Such termination rights shall be in addition to and not in substitution
for any other remedies that may be available to the non-defaulting party.
Termination pursuant to this Section 12.2 shall not relieve the defaulting party
from liability and damages to the other party for breach of this Agreement.
Waiver by either party of a single default or a succession of defaults shall not
deprive such party of any right to terminate this Agreement arising by reason of
any subsequent default.
12.3 Termination Upon Bankruptcy. This Agreement may be
terminated by SEMACO giving written notice of termination to CancerVax upon the
filing of bankruptcy or bankruptcy of CancerVax or the appointment of a receiver
of any of CancerVax's assets, or the making by CancerVax of any assignment for
the benefit of creditors, or the institution of any proceedings against
CancerVax under any bankruptcy law. Termination shall be effective upon the date
specified in such notice.
12.4 Termination by CancerVax. CancerVax may terminate
this Agreement at any time in CancerVax's sole discretion upon not less than
sixty (60) days' prior written notice to SEMACO; provided, however, that nothing
herein is intended or shall be construed to release CancerVax from any
obligations arising prior to the effective date of termination, including, but
16
not limited to, CancerVax's obligation to pay SEMACO the Prior Patent Expenses
or any other patent expenses that were incurred under the terms of this
Agreement prior to the effective date of termination.
12.5 Rights Upon Expiration. Neither party shall have any
further rights or obligations upon the expiration of this Agreement upon its
regularly scheduled expiration date with respect to this Agreement, other than
the obligation of CancerVax to make any and all reports and payments for the
final quarter period; and the payment of any patent expenses required to be paid
by CancerVax under this Agreement, including, but not limited to the Prior
Patent Expenses provided, however, that upon such expiration, each party shall
be required to continue to abide by its non-disclosure obligations as described
in Section 11.1, and CancerVax will continue to abide by its obligation to
indemnify SEMACO, the University and others, as required under Section 8 hereof.
12.6 Rights Upon Termination. Notwithstanding any other
provision of this Agreement, upon any termination of this Agreement prior to the
regularly scheduled expiration date of this Agreement, the license granted
hereunder shall terminate. Except as otherwise provided in Section 12.7 of this
Agreement with respect to work-in-progress, upon such termination, CancerVax
will have no further right to develop, manufacture or market any Licensed
Product, or to otherwise use any the Patent Rights or any Licensed Technology
not otherwise includable therein. Upon any such termination, CancerVax will
return all materials, samples, documents, information and other materials which
embody or disclose the Patent Rights or any Licensed Technology not otherwise
includable therein; provided, however, that CancerVax shall not be obligated to
provide SEMACO with proprietary information which CancerVax can show that it
independently developed. Any such termination shall not relieve either party
from any obligations accrued to the date of such termination. Upon such
termination, each party shall be required to abide by its nondisclosure
obligations as described in Section 11.1, and CancerVax will continue to abide
by its obligations to indemnify SEMACO, the University and others, as required
under Section 8 hereof.
12.7 Work-in-Progress. Upon any such early termination of
the license granted hereunder in accordance with this Agreement, CancerVax shall
be entitled to finish any work-in-progress and to sell any completed inventory
of a Licensed Product covered by such license which remain on hand as of the
date of the termination, so long as CancerVax pays to SEMACO the royalties or
any other monies applicable to said subsequent sales in accordance with the
terms and conditions as set forth in this Agreement, provided that no such sales
shall be permitted after the expiration of six (6) months after the date of
termination.
13. Assignment; Successors.
13.1 Assignment. None of the parties shall have the right
to assign, delegate or transfer at any time to any party, in whole or in part,
any or all of the rights, duties and interest granted herein without first
obtaining the written consent of the other parties to such assignment, which
consent shall not be unreasonably withheld; provided, however, that no prior
written consent shall be required for an assignment of this Agreement by SEMACO
to the University, nor shall written consent be required in the event that a
third party acquires substantially all of
17
the assigning party's assets or outstanding shares, or merges with the assigning
party. Any attempted assignment not in compliance with this Section 13.1 shall
be of no force or effect.
13.2 Binding Upon Successors and Assigns. Subject to the
limitations on assignment herein, this Agreement shall be binding upon and inure
to the benefit of any successors in interest and assigns of SEMACO and
CancerVax. Any such successor or assignee of CancerVax's interest shall
expressly assume in writing the performance of all the terms and conditions of
this Agreement to be performed by CancerVax.
14. General Provisions.
14.1 Independent Contractors. The relationship between
SEMACO and CancerVax is that of independent contractors. SEMACO and CancerVax
are not joint venturers, partners, principal and agent, master and servant, nor
employer and employee, and have no other relationship other than independent
contracting parties. SEMACO and CancerVax shall have no power to bind or
obligate each other in any manner, other than as is expressly set forth in this
Agreement.
14.2 Arbitration. Any controversy or claim arising out of
or relating to this Agreement, or the breach thereof, shall be settled by
binding arbitration in accordance with the Commercial Arbitration Rules of the
American Arbitration Association ("AAA"), and the procedures set forth below;
provided, however, that the parties reserve the right at all times to seek
injunctive or other equitable relief in any court having jurisdiction thereof.
In the event of any inconsistency between the Rules of AAA and the procedures
set forth below, the procedures set forth below shall control. Judgment upon the
award rendered by the arbitrators may be enforced in any court having
jurisdiction thereof.
14.2.1 Location. The location of the arbitration
shall be in New York City, New York.
14.2.2 Selection of Arbitrators. The arbitration
shall be conducted by a panel of three (3) neutral arbitrators who are
independent and disinterested with respect to the parties, this Agreement, and
the outcome of the arbitration. Each party shall appoint one neutral arbitrator,
and these two arbitrators so selected by the parties shall then select the third
arbitrator. If one party has given written notice to the other party as to the
identity of the arbitrator appointed by the party, and the party thereafter
makes a written demand on the other party to appoint its designated arbitrator
within the next thirty (30) days, and the other party fails to appoint its
designated arbitrator within thirty (30) days after receiving said written
demand, then the arbitrator who has already been designated shall appoint the
other two (2) arbitrators.
14.2.3 Discovery. Unless the parties mutually agree
in writing to some additional and specific pre-hearing discovery, the only
pre-hearing discovery shall be (i) reasonably limited production of relevant and
non-privileged documents, and (ii) the identification of witnesses to be called
at the hearing, which identification shall give the witness's name, general
qualifications and position, and a brief statement as to the general scope of
the testimony to be given by the witness. The arbitrators shall decide any
disputes and shall
18
control the process concerning these pre-hearing discovery matters. Pursuant to
the Rules of AAA, the parties may subpoena witnesses and documents for
presentation at the hearing.
14.2.4 Case Management. Prompt resolution of any
dispute is important to both parties; and the parties agree that the arbitration
of any dispute shall be conducted expeditiously. The arbitrators are instructed
and directed to assume case management initiative and control over the
arbitration process (including scheduling of events, pre-hearing discovery and
activities, and the conduct of the hearing), in order to complete the
arbitration as expeditiously as is reasonably practical for obtaining a just
resolution of the dispute.
14.2.5 Remedies. The arbitrators may grant any
legal or equitable remedy or relief that the arbitrators deem just and
equitable, to the same extent that remedies or relief could be granted by a
state or federal court, provided however, that no punitive damages may be
awarded. No court action may be maintained seeking punitive damages. The
decision of any two (2) of the three (3) arbitrators appointed shall be binding
upon the parties.
14.2.6 Expenses. The expenses of the arbitration,
including the arbitrators' fees, expert witness fees and attorney's fees, may be
awarded to the prevailing party, in the discretion of the arbitrators, or may be
apportioned between the parties in any manner deemed appropriate by the
arbitrators. Unless and until the arbitrators decide that one party is to pay
for all (or a share) of such expenses, all parties shall share equally in the
payment of the arbitrators' fees as and when billed by the arbitrators.
14.2.7 Confidentiality. Except as set forth below,
the parties shall keep confidential the fact of the arbitration, the dispute
being arbitrated, and the decision of the arbitrators. Notwithstanding the
foregoing, the parties may disclose information about the arbitration to persons
who have a need to know, such as directors, trustees, management employees,
witnesses, experts, investors, attorneys, lenders, insurers, the University, and
others who may be directly affected. Additionally, if a party has stock which is
publicly traded, the party may make such disclosures as are required by
applicable securities laws. Further, if a party is expressly asked by a third
party about the dispute or the arbitration, the party may disclose and
acknowledge in general and limited terms that there is a dispute with the other
party which is being (or has been) arbitrated. Once the arbitration award has
become final, if the arbitration award is not promptly satisfied, then these
confidentiality provisions shall no longer be applicable.
14.3 Entire Agreement; Modification. This Agreement sets
forth the entire agreement and understanding between the parties as to the
subject matter hereof. There shall be no amendments or modifications to this
Agreement, except by a written document which is signed by the parties.
14.4 Delaware Law. This Agreement shall be construed and
enforced in accordance with the laws of the State of Delaware without regard to
the conflicts of laws principles thereof.
19
14.5 Headings. The headings for each article and section
in this Agreement have been inserted for convenience of reference only and are
not intended to limit or expand on the meaning of the language contained in the
particular article or section.
14.6 Severability. Should any one or more of the
provisions of this Agreement be held invalid or unenforceable by a court of
competent jurisdiction, it shall be considered severed from this Agreement and
shall not serve to invalidate the remaining provisions thereof. The parties
shall make a good faith effort to replace any invalid or unenforceable provision
with a valid and enforceable one such that the objectives contemplated by them
when entering this Agreement may be realized.
14.7 No Waiver. Any delay in enforcing a party's rights
under this Agreement or any waiver as to a particular default or other matter
shall not constitute a waiver of such party's rights to the future enforcement
of its rights under this Agreement, excepting only as to an express written and
signed waiver as to a particular matter for a particular period of time.
14.8 Name. Whenever there has been an assignment or a
sublicense by CancerVax as permitted by this Agreement, the term "CancerVax" as
used in this Agreement shall also include and refer to, if appropriate, such
assignee or sublicensee.
14.9 Attorneys' Fees. In the event of a dispute between
the parties hereto or in the event of any default hereunder, the party
prevailing in the resolution of any such dispute or default shall be entitled to
recover its reasonable attorneys' fees and other costs incurred in connection
with resolving such dispute or default.
14.10 Notices. Any notices required by this Agreement shall
be in writing, shall specifically refer to this Agreement and shall be sent by
registered or certified airmail, postage prepaid, or by telefax, telex or cable,
charges prepaid, or by overnight courier, postage prepaid and shall be forwarded
to the respective addresses set forth below unless subsequently changed by
written notice to the other party:
For SEMACO: SEMACO, Inc.
c/o Xxxxxxx Xxxxxxxxx
000 Xxxxxx Xx.
Xxxxxx XX 00000
Fax No.: 000 000-0000
For Gilchrest: Xx. Xxxxxxx Xxxxxxxxx
Xxxxx Xxxxx
Xx. 00
Xxxxxx XX 00000
Fax No.: 000 000-0000
For CancerVax: CancerVax Corporation
0000 Xxxxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Attention: General Counsel
Fax No.: (000) 000-0000
20
Notice shall be deemed delivered upon the earlier of (i) when received, (ii)
three (3) days after deposit into the mail, (iii) the date notice is sent via
telefax, telex or cable or (iv) the day immediately following delivery to
overnight courier (except Sunday and holidays).
14.11 University and University License Agreement. This
Agreement shall be construed in accordance with and shall be subject to the
terms and conditions of the University License Agreement. Nothing herein or in
the consulting agreement or other related agreement with SEMACO or Xxxxxxxxx
shall be construed to require the University, Xxxxxxxxx, or any other University
personnel to violate any University policy or procedures, and SEMACO and
Xxxxxxxxx'x obligations under this Agreement, the consulting agreement and any
other related agreement shall be subject to all University policies and
procedures. The University is not a party to this Agreement and is not bound by
any act or omission of SEMACO or Xxxxxxxxx.
14.12 Compliance with Laws. Nothing contained in this
Agreement shall require or permit the parties to do any act inconsistent with
the requirements of any applicable law, regulation or order of the United States
or any state or local law or the law of any foreign jurisdiction as the same may
be in effect from time to time. The parties shall comply with all such
applicable laws, regulations rules and orders.
14.13 Securities Laws. SEMACO hereby acknowledges that it
is aware that the securities laws of the United States prohibit any person who
has material, non-public information concerning CancerVax or a possible
transaction involving CancerVax from purchasing or selling securities in
reliance upon such information or from communicating such information to any
other person or entity under circumstances in which it is reasonably foreseeable
that such person or entity is likely to purchase or sell such securities in
reliance upon such information.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
21
IN WITNESS WHEREOF, the parties have executed this Agreement by their
duly authorized representatives as of the date set forth above.
SEMACO: CANCERVAX:
SEMACO, Inc. CancerVax Corporation
/s/ Xxx Xxxxx /s/ Xxxxx X. Xxxx
------------------------------------- -------------------------------------
By: Xxx Xxxxx By: Xxxxx X. Xxxx
Title: Chief Executive Officer Title: President and CEO
XXXXXXXXX:
/s/ Xxxxxxx Xxxxxxxxx
-------------------------------------
By: Xx. Xxxxxxx Xxxxxxxxx (For
purposes of Sections 4.3, 7.1, 10.3
and 11.3 only)
[SIGNATURE PAGE TO SEMACO SUBLICENSE AGREEMENT]
00
XXXXXXX X-0
XXXXXX XXXXXX
XXXXXX XXXXXX PATENT LIST
[***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
EXHIBIT A-2
PATENT RIGHTS
FOREIGN PATENT LIST
[2 Pages of Foreign Patents Deleted Pursuant to Confidential Treatment Request]
EXHIBIT B
MILESTONE PAYMENTS
MILESTONE PAYMENT
--------- -------
(1) An initial license issue fee to be paid upon signing this Agreement [***]
(2) Upon the transfer to CancerVax of copies of all patent applications. [***]
(3) Upon the transfer to CancerVax of copies of all lab notebooks, procedures, methods, [***]
unique reagents, other data, information, and the like reasonably required by CancerVax
to accomplish its obligations under this Agreement, and an index to such materials within
60 days following the Effective Date.
(4) Upon approval of an Investigational New Drug ("IND") by the U.S. Food and Drug [***]
Administration ("FDA") or an equivalent approval to initiate clinical trials in a
jurisdiction other than the United States on the first Licensed Product
(5) Upon the first dosing of a patient participating in a Phase II clinical trial [***]
conducted by CancerVax on the first Licensed Product
(6) Upon a demonstration of safety and efficacy based upon the final results of a Phase [***]
II clinical trial conducted by CancerVax on the first Licensed Product
(7) Upon the submission of a Biologics License Agreement ("BLA") (or, if applicable, New [***]
Drug Application ("NDA")) to the FDA on the first Licensed Product
(8) Upon the approval by the FDA of a BLA (or, if applicable, NDA) on the first Licensed [***]
Product
(9) Upon approval by the European Union ("EU") to market the first Licensed Product [***]
(10) Upon approval by Japan to market the first Licensed Product [***]
(11) Upon the first commercial sale of the first Licensed Product in a country other [***]
than the United States, EU or Japan if such sale occurs prior to the first commercial
sale in the United States, EU or Japan
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
(11) Upon the occurrence of the same events listed in items (4) through (10) with [***]
respect to each additional Licensed Product; provided, however, that additional
indications for use of a Licensed Product will not be considered an additional Licensed
Product for purposes of payment of the milestones.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
EXHIBIT C
RESPONSIBILITIES OF CANCERVAX
1. Perform due diligence to evaluate the Licensed Technology, the Licensed
Know-How and the Patent Rights;
2. Develop commercially viable formulation(s) for the Licensed Products;
3. Conduct pre-clinical testing and analyses of the Licensed Products to
support an IND filing, including toxicology, safety, pharmacokinetics
and other required in-vitro and in-vivo studies and testing;
4. Develop manufacturing processes, analytical and quality control methods
and tests related to the Licensed Products;
5. Develop contract manufacturing source(s) to provide sufficient
quantities of the Licensed Products to support pre-clinical testing,
clinical trial and commercialization requirements;
6. Develop protocol(s) for clinical trials, perform clinical trials
required for regulatory approval in the United States, the EU, Japan
and other commercially reasonable markets to be selected by CancerVax,
in its reasonable discretion (the "Target Markets");
7. Prepare and prosecute all regulatory submissions which are required in
the development of the Licensed Products and shall seek approval to
market the Licensed Products in the Target Markets;
8. Perform market research and develop a marketing plan for the Licensed
Products, and market the Licensed Products in the Target Markets,
either directly or through relationships with other third parties; and
9. Develop and commercialize the Licensed Technology for use in the Field
based upon positive results of preclinical and clinical studies.
EXHIBIT D
RESPONSIBILITIES OF SEMACO AND XXXXXXXXX
1. Transfer to CancerVax all knowledge, know-how, copies of data, records
and such other information as SEMACO and/or Xxxxxxxxx may possess
related to the methods of use, testing (preclinical and clinical),
production, purification and characterization of the Licensed
Technology or the Licensed Products; as CancerVax may request from time
to time
2. Disclose to CancerVax, all inventions related to the Joint Improvements
or SEMACO Improvements, whether or not patentable, and take all steps
necessary to assign to CancerVax such rights, title and interest in, or
license to, such Joint Improvements or SEMACO Improvements in
accordance with the terms of this Agreement.
3. Provide reasonable assistance to CancerVax, at CancerVax's cost, in
obtaining any additional Intellectual Property Rights that are
necessary or would be useful to CancerVax in relation to the Licensed
Technology;
4. Provide reasonable assistance to CancerVax, at CancerVax's cost, in
licensing from other third parties any additional Intellectual Property
Rights, manufacturing, purification, analytical, testing or know-how
related to the Licensed Technology and/or the Licensed Know-How; and
5. Perform the Research Program in accordance with the timetables agreed
upon between SEMACO and CancerVax.
EXHIBIT E
LETTER AGREEMENT BETWEEN
UNIVERSITY, SEMACO AND CANCERVAX
[LETTERHEAD OF SEMACO, INC.]
March__, 2004
Trustees of Boston University
Office of the Treasurer
000 Xxxxxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Treasurer / Assistant Treasurer
Re: License Agreement, by and between Trustees of Boston
University ("BOSTON UNIVERSITY") and SemaCo, Inc. ("SEMACO"),
dated as of December 11, 2001 (the "LICENSE AGREEMENT")
Ladies and Gentlemen:
We are delivering this Letter of Acknowledgment and Consent in connection with
the above-referenced License Agreement.
Under Section 2 of the License Agreement, Boston University granted to SEMACO,
among other things, the right to enter into Sublicenses. In furtherance of this
grant and its obligations under the License Agreement, SEMACO is in the process
of negotiating a Sublicense agreement (the "SUBLICENSE AGREEMENT") by and among
SEMACO and Xxxxxxx Xxxxxxxxx, M.D., on the one hand, and CancerVax Corporation,
on the other hand. A copy of the form of the Sublicense Agreement is attached
hereto as Exhibit A.
By executing this Letter of Acknowledgment and Consent, Boston University
acknowledges and consents to SEMACO entering into the Sublicense Agreement in
substantially the form attached hereto. Further, Boston University confirms and
agrees as of the date hereof: (a) the License Agreement is in full force and
effect and has not been amended or restated; (b) to the best of its knowledge,
no default or material breach exists under the License Agreement; and (c)
notwithstanding any provisions in the License Agreement to the contrary, so long
as CancerVax Corporation is not in material breach of the Sublicense Agreement,
upon termination of the License Agreement for any reason, Boston University (i)
shall continue the Sublicense Agreement in full force and effect and on all the
material terms set forth in the Sublicense Agreement in the form attached hereto
or as subsequently amended and accepted by Boston University, and (ii) hereby
waives any rights it may have (if any) to renegotiate any provisions in such
form of the Sublicense Agreement.
The consents, acknowledgments and waivers contained herein are limited to the
specifics hereof, shall not excuse future non-compliance with the License
Agreement, and, except as expressly set forth herein, shall not operate as an
acknowledgment, consent or waiver of any right, power or remedy of Boston
University, nor as a consent to or waiver of any further or other matter, under
the License Agreement or under the Sublicense Agreement if continued after
termination of the License Agreement.
All capitalized terms used and not otherwise defined herein shall have the
meanings ascribed to such terms in the License Agreement.
Sincerely,
SEMACO, Inc.
________________________
By:
Its:
Acknowledged and Agreed this __ day of March, 2004
Trustees of Boston University
___________________________
By: _______________________
Its: ______________________
Acknowledged this __ day of March, 2004
CancerVax Corporation
___________________________
By: Xxxxx X. Xxxx
Its: President and CEO
Exhibit A: Sublicense Agreement
