License Agreement - M-Tech Therapeutics Inc. and CancerVax Corp.
LICENSE AGREEMENT
BY AND BETWEEN
M-TECH THERAPEUTICS, INC.,
A CALIFORNIA CORPORATION
AND
CANCERVAX CORPORATION,
A DELAWARE CORPORATION
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LICENSE AGREEMENT
This License Agreement is entered into and made effective as of this 4
day of October, 2002 (the "Effective Date"), by and between M-Tech Therapeutics,
Inc., a California corporation ("M-Tech") located at 800 Silverado Street, 2nd
Floor, La Jolla, California, 92037, and CancerVax Corporation, a Delaware
corporation ("CancerVax") with offices located at 2110 Rutherford Road,
Carlsbad, California, 92008, with respect to the facts set forth below. M-Tech
and CancerVax are sometimes each hereinafter referred to as a "Party" or,
collectively, as "Parties" to this Agreement.
RECITALS
A. M-Tech is engaged in biomedical research including
research relating to monoclonal antibodies.
B. CancerVax is engaged in the discovery, development
and commercialization of biological products for the treatment, prevention and
control of cancer.
C. M-Tech has disclosed to CancerVax certain technology
described in Exhibit A hereto (the "M-Tech Technology"), which is incorporated
herein by reference.
D. M-Tech has the exclusive right to grant a license to
the technology described in the M-Tech Technology.
E. M-Tech desires to grant to CancerVax, and CancerVax
wishes to acquire, an exclusive worldwide right and license to the technology
described in the M-Tech Technology, subject to the terms and conditions set
forth herein, with a view to developing and marketing diagnostic and/or
therapeutic products.
F. M-Tech and its Affiliates desire to obtain a release
from CancerVax for the use of certain cell lines owned by CancerVax.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and
conditions set forth herein, M-Tech and CancerVax 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 a Party hereto. 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.
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1.2 Confidential Information. The term "Confidential Information"
shall mean any and all proprietary or confidential information of M-Tech,
CancerVax or their Affiliates 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:
a. is publicly available through no fault of any Party hereto,
either before or after it becomes known to the receiving Party;
b. was known to the receiving Party prior to the date of this
Agreement, as shown by contemporaneous written documentation, which knowledge
was acquired independently and not from another Party hereto (or such Party's
employees);
c. is subsequently disclosed to the receiving Party in good faith
by a third party who has a right to make such disclosure; or
d. has been published by a third party as a matter of right.
1.3 Improvements. The term "Improvements" shall mean any
improvement in or modification to the M-Tech Technology or a Licensed Product
(as such terms are defined below) that is directly related to the M-Tech
Technology or a Licensed Product, made individually by either Party.
1.4 Joint Improvements. The term "Joint Improvements" shall mean
improvement in or modification to the M-Tech Technology or a Licensed Product
(as such terms are defined below) that is directly related to the M-Tech
Technology or a Licensed Product, made jointly by the Parties.
1.5 Licensed Antibodies. The term "Licensed Antibodies" shall mean
the antibodies set forth in Exhibit A hereto, and any subsequent monoclonal
antibodies owned, licensed or developed by M-Tech or its Affiliates that are
directed towards the same antigens as the antibodies listed in Exhibit A.
Expressly excluded from the Licensed Antibodies are any subclone cell lines
isolated from the [***] cell line other than those that primarily produce human
monoclonal antibodies to [***], whether alone or in combination with other
antigens.
1.6 Licensed Antibody Know-How. The term "Licensed Antibody
Know-How" shall mean all data, information, know-how, technology, research
results, methods of manufacture, purification, testing and analysis developed
and/or used by M-Tech or its Affiliates in relation to the Licensed Antibodies
which M-Tech may disclose or transfer to CancerVax without violating any
Pre-Existing Obligations (as such term is defined below) including, without
limitation, all data and information developed by M-Tech or its Affiliates which
could be used to support an Investigational New Drug Application ("IND")
regarding the Licensed Antibodies, provided, however, that the Licensed Antibody
Know-How shall not include the methods and/or associated know-how used by M-Tech
or its Affiliates to establish human monoclonal antibody-producing cell lines.
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1.8 Licensed Product. The term "Licensed Product" shall mean any
product, article, composition, apparatus, substance, chemical or any other
material for therapeutic or diagnostic use which is covered by the Patent Rights
or the Property Rights, incorporates the Licensed Antibodies or is discovered,
derived or developed using the M-Tech Technology, as such terms are defined
herein.
1.9 Patent Rights. The term "Patent Rights" shall mean rights
arising out of or resulting from (i) any and all U.S. and foreign patents and
patent applications directly related to the Licensed Products which M-Tech or
its Affiliates may disclose and transfer to CancerVax without violating and
Pre-Existing Obligations, however acquired, (ii) the patents proceeding from
such applications, (iii) divisions, substitutes, continuations, continuations-in
part, reexaminations, reissues, renewals, extensions, additions, corresponding
foreign patents or patent applications, and compositions of matter of any patent
or application set forth in (i)-(ii) above.
1.10 M-Tech Technology. The term "M-Tech Technology" shall mean the
Licensed Antibodies, Licensed Antibody Know-How, Patent Rights and Property
Rights, all as more fully described in Exhibit A hereto, information and
know-how related thereto whether or not the same is eligible for protection
under the patent laws of the United States or elsewhere, and whether or not any
such processes and technology, or information related thereto, would be
enforceable as a trade secret or the copying of which would be enjoined or
restrained by a court as constituting unfair competition.
1.11 Net Sales. The term "Net Sales" shall mean the gross amount
received by CancerVax or its Affiliates and sublicensees, or any of them, upon
payment of invoice, on all sales of Licensed Products, less (i) discounts
actually allowed, (ii) credits for claims, allowances, retroactive price
reductions or returned goods, (iii) prepaid freight and (iv) sales taxes or
other governmental charges actually paid in connection with sales of Licensed
Products (but excluding what are commonly known as income taxes and value-added
taxes). For purposes of determining Net Sales, a sale shall be deemed to have
occurred when an invoice therefor shall be generated and payment received by
CancerVax, or its Affiliates or sublicensees or any of them. Sales of Licensed
Products by CancerVax, or an Affiliate or sublicensee of CancerVax to any
Affiliate or sublicensee which is a reseller thereof shall be excluded, and only
the subsequent sale of such Licensed Products by Affiliates or sublicensees of
CancerVax to unrelated parties shall be deemed Net Sales hereunder.
1.12 Pre-Existing Obligations. The term "Pre-Existing Obligations"
shall mean any written contractual obligations with respect to the Licensed
Antibody Know-How or the Patent Rights that were in effect prior to March 22,
2002, between M-Tech or any of its Affiliates and any third parties. A list of
all such contractual obligations is attached as Exhibit B hereto.
1.13 Property Rights. The term "Property Rights" shall mean all of
M-Tech's or its Affiliates' property rights to the biological material described
as the [***] cell lines and the monoclonal antibodies set forth in Exhibit A
hereto, their progeny, derivatives, variations
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and modifications, including any antibodies, proteins, nucleic acids,
lipoproteins, lipids and/or biomolecules produced and/or secreted by such
materials, however acquired.
1.14 Release Agreement. The term "Release Agreement" shall
mean a Release Agreement between CancerVax, on the one hand, and M-Tech and its
Affiliates, on the other hand, in the form set forth in Exhibit C hereto, which
shall be executed by the Parties concurrently with this Agreement.
1.15 Target Markets. The term "Target Markets" shall mean the
CancerVax based on its assessment of the potential for commercial viability of
the Licensed Products therein.
2. Reimbursement of Expenses; License Terms and Conditions.
2.1 Reimbursement of Expenses. CancerVax has agreed to pay to
M-Tech a total of U.S. [***] as reimbursement for out of pocket expenses related
to transfer of the M-Tech Technology. On March 29, 2002, CancerVax paid to
M-Tech a nonrefundable payment of U.S. [***] of this amount, and within ten days
after the Effective Date, CancerVax agrees to pay the balance of U.S. [***].
2.2 Grant of Rights.
2.2.1 Exclusive License. M-Tech hereby grants to CancerVax
an exclusive, worldwide license, including the right to sublicense, to the
M-Tech Technology, and any Improvements and Joint Improvements thereto,
including a bailment to possess the Licensed Antibodies and Property Rights and
transfer possession of the same under a valid sublicense, to make, to have made,
to import, to export, to use, to offer for sale, and to sell Licensed Products,
subject to the terms of this Agreement.
2.2.2 Non-Exclusive License to Joint Improvements. In the
event that this Agreement is terminated or expires for any reason, M-Tech shall
automatically grant to CancerVax a non-exclusive, perpetual, fully paid up,
non-royalty bearing, worldwide license, including the right to sublicense, to
any Joint Improvements, which non-exclusive license shall survive and
termination or expiration of this Agreement.
2.2.3 Government Rights. CancerVax acknowledges that
certain of the M-Tech Technology was developed, in part, with funds furnished by
the Government of the United States of America (the "Government"), and that the
Government may have certain rights relative thereto. This Agreement is
explicitly made subject to the Government's rights, if any, under any applicable
law or regulation. To the extent that there is a conflict between any such
applicable law or regulation and this Agreement, the terms of such applicable
law or regulation shall prevail.
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2.2.4 Retained Rights. M-Tech and its Affiliates shall
retain a non-exclusive right and license to make, have made and use the M-Tech
Technology, Improvements and Joint Improvements for non-commercial research
purposes only, including the right to publish the general scientific findings
from research related thereto in scholarly journals and publications; provided,
however, that any such publications by M-Tech or its Affiliates shall made be in
accordance with the provisions of Section 9.2 hereof.
2.3 License Fees.
2.3.1 Initial License Fee. In partial consideration for the
exclusive license granted pursuant to Section 2.2.1 hereof, CancerVax paid to
M-Tech on March 29, 2002, a nonrefundable license fee in the amount of U.S.
[***] for the M-Tech Technology related to the [***] cell line. The license fee
described in this Section is consideration for signing of a definitive term
sheet preceding this Agreement and for the grant and continuation of the license
hereunder, and M-Tech shall have no obligation whatsoever, under any
circumstances, to return any portion of such license fee, including, but not
limited to, any failure by CancerVax to develop any Licensed Product or market
any Licensed Product commercially, and notwithstanding the volume of sales of
any such Licensed Product. On January 2, 2003, CancerVax shall pay to M-Tech an
additional license fee of U.S. [***] for the M-Tech Technology related to the
[***] cell line and U.S. [***] for the M-Tech Technology related to the [***]
cell line.
2.3.1 Annual License Fee. In order to maintain the license
granted hereunder in force, beginning on the first 12-month anniversary of the
Effective Date, CancerVax shall pay to M-Tech a fee of U.S. Ten Thousand Dollars
(US $10,000.00); the "Annual License Fee") for each of the three (3) cell lines
described in Exhibit A hereto that are included in the M-Tech Technology. In the
event that any of the cell lines included in the M-Tech Technology are no longer
included in the license granted hereunder, no Annual License Fee shall be paid
by CancerVax with respect thereto. CancerVax shall continue to pay the Annual
License Fee on each subsequent 12-month anniversary of the Effective Date until
the date of first commercial sale of any Licensed Product.
2.4 Milestones. In consideration for the License granted to
CancerVax, CancerVax shall pay a milestone payment to M-Tech upon the occurrence
of each event specified below. Payment of the milestones shall be due within
sixty (60) days of achievement of the event.
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Event Milestone Payment
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Approval of an Investigational New Drug application [***]
in the U.S., or a similar application to initiate
clinical studies in any country other than the U.S.
("IND"), for each Licensed Product.
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Initiation of a Phase III clinical trial in the [***]
U.S., or in any country other than the U.S., for
each Licensed Product.
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Approval by the U.S. Food & Drug Administration [***]
("FDA") of a Biologics License Application ("BLA")
on each Licensed Product.
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Approval by the European Union ("EU") to market the [***]
first Licensed Product.
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Approval by the European Union ("EU") to market any [***]
subsequent Licensed Product.
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Approval by Japan to market each Licensed Product. [***]
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2.5 Royalties
2.5.1 Royalty Payments for Sales by CancerVax and its
Affiliates. As additional consideration for the exclusive license granted
pursuant to Section 2.2.1 hereof, CancerVax shall pay to M-Tech a continuing
royalty on a country-by-country basis in the amount of [***] of Net Sales of all
Licensed Products by CancerVax or its Affiliates. With regard to Net Sales made
by 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 during such preceding calendar quarter,
commencing with the calendar quarter in which the first commercial sale of any
Licensed Product is made.
2.5.2 Royalty Payments for Sales by Sublicensees. If
CancerVax receives a royalty from a sublicensee under this Agreement, M-Tech
shall receive [***] of any such royalty paid to CancerVax or its Affiliates, but
in no instance less than a [***] royalty nor greater than a [***] royalty on Net
Sales made by any such sublicensee. With regard to Net Sales made by
sublicensees of CancerVax or its Affiliates, royalties shall be payable by
CancerVax quarterly, within ninety (90) 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.
2.5.3 Royalty Payments to Third Parties. In the event that
CancerVax or its Affiliates or sublicensees must pay a royalty to a third party
in relation to the sale of a Licensed Product based upon rights dominating those
licensed by M-Tech hereunder, to the extent the total royalty burden on a given
Licensed Product exceeds [***] of Net Sales, the royalty payable to M-Tech will
be reduced by the amount of any such third party royalty, provided, however, in
no instance whatsoever shall the royalty payable to M-Tech by CancerVax or its
Affiliates or sublicensees be less than [***] of Net Sales.
2.5.4 Royalty Floor. In no instance shall the royalty
payable to M-Tech by CancerVax, its Affiliates or sublicensees ever be less than
[***] of Net Sales, if any.
2.6 Other Payments. With respect to sublicenses granted to any
third party (other than an Affiliate of CancerVax) for the use of the M-Tech
Technology exclusively licensed hereunder, CancerVax shall pay to M-Tech an
amount equal to [***] of certain other consideration received in connection with
the granting of the sublicense including, but not
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limited to, all technology access fees, license fees, lump sum payments and the
like, but excluding research support received by CancerVax or its Affiliates and
payments for equity of CancerVax or its Affiliates.
2.7 Term of License. Unless terminated sooner in accordance with
the provisions of this Agreement, the term of the license granted under Section
2.2.1 hereof shall expire when the last of the royalty obligations set forth 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 License Agreement shall be so shortened or this
License Agreement shall be amended to provide for a non-exclusive license, and,
in such event, M-Tech shall consider in good faith any request by CancerVax or
its Affiliates to reduce the royalties payable as set forth under the section
heading "Royalties" hereof.
2.8 Sublicense. CancerVax shall have the sole and exclusive right
to grant sublicenses to any other party with respect to the rights conferred
upon CancerVax under this Agreement, provided, however, that any such sublicense
shall be subject in all respects to the restrictions, exceptions, royalty
obligations, reports, termination provisions, and other provisions contained in
this Agreement (but not including the payment of license fees pursuant to
Section 2.2 hereof).
2.9 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 Patent Rights
utilized by or in such Licensed Product in each such country or, with respect to
Licensed Products not utilizing any Patent Rights, fifteen (15) years after the
date of first commercial sale of such Licensed Product in such country.
2.10 Reports
2.10.1 Royalty Reports. CancerVax shall furnish to M-Tech at
the same time as each royalty payment is made by CancerVax, 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.
2.10.2 Progress Reports. CancerVax shall furnish to M-Tech,
on or before the anniversary of the Effective Date each year during the Term, a
confidential, written report summarizing its progress with respect to its use of
the M-Tech Technology. Subsequently, CancerVax shall also furnish a report to
M-Tech with respect to the development and commercialization of Licensed
Products. Among other things, such reports shall include the current status and
timetable for developing Licensed Products, including, if applicable, plans for
preclinical studies and estimated dates for initiation and completion of
clinical trials for commercialization.
2.11 Records. CancerVax shall keep, and cause its Affiliates and
sublicensees to keep, full, complete and proper records and accounts of all
sales of Licensed Products in sufficient
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detail to enable the royalties payable on Net Sales of each Licensed Product to
be determined. M-Tech shall have the right to appoint an independent certified
public accounting firm approved by CancerVax, which approval shall not be
unreasonably withheld, 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 M-Tech shall execute a confidentiality
agreement with CancerVax prior to performing such audit. Such audit shall be at
M-Tech's expense; provided, however, that if the audit discloses that M-Tech 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 shall reimburse M-Tech for any such audit costs.
M-Tech may exercise its right of audit as to each of CancerVax, its Affiliates
or sublicensees no more frequently than once in any calendar year. The
accounting firm shall disclose to M-Tech only information relating to the
accuracy of the royalty payments. CancerVax, its Affiliates and sublicensees
shall preserve and maintain all such records required for audit for a period of
five (5) years after the calendar quarter to which the record applies.
2.12 Foreign Sales. The remittance of royalties payable on Net
Sales outside the United States shall be payable to M-Tech in United States
Dollar, computed at an average of the official rate of exchange of the currency
of the country from which the royalties are payable, as quoted in the Wall
Street Journal, West Coast Edition, for the fifteen day period prior to 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 M-Tech or its nominee in any commercial bank
or trust company of M-Tech's choice located in that country, prompt written
notice of which shall be given by CancerVax to M-Tech. After M-Tech has been so
notified, those monies shall be considered as royalties duly paid to M-Tech and
will be completely controlled by M-Tech, and CancerVax will have no further
responsibilities with respect thereto.
2.13 Foreign Taxes. CancerVax shall promptly inform M-Tech of any
tax required to be withheld by CancerVax under the laws of any foreign country
for the accounts of M-Tech. With M-Tech's prior written approval, which approval
shall not be unreasonably withheld, such tax shall be promptly paid by CancerVax
for and on behalf of M-Tech to the appropriate governmental authority, and
CancerVax shall use its best efforts to furnish M-Tech 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 M-Tech's behalf
shall be deducted from royalty payments due M-Tech.
3. Patent Matters.
3.1 Patent Prosecution and Maintenance. From and after the date of
this Agreement, the provisions of this Section 3 shall control the prosecution
and maintenance of any patent included within Patent Rights. Subject to the
requirements, limitations and conditions set forth in this Agreement, CancerVax
shall direct and control (i) the preparation, filing and prosecution of the
United States and foreign patent applications within Patent Rights (including
any
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interferences and foreign oppositions) and (ii) maintain the patents issuing
therefrom. CancerVax shall select the patent attorney, subject to M-Tech's
written approval, which approval shall not be unreasonably withheld. M-Tech
shall have reasonable rights of consultation with the patent attorney so
selected on all matters relating to Patent Rights. CancerVax shall use its best
efforts to implement all reasonable requests made by M-Tech with regard to the
preparation, filing, prosecution and/or maintenance of the patent applications
and/or patents within Patent Rights.
3.2 Information to M-Tech. CancerVax shall keep M-Tech informed
with regard to the patent application and maintenance processes. CancerVax shall
deliver to M-Tech copies of all patent applications, amendments, related
correspondence, and other related matters.
3.3 Patent Costs. CancerVax shall reimburse M-Tech for all
reasonable, actual patent maintenance and prosecution expenses incurred by
M-Tech or its Affiliates prior to the Effective Date to the extent that such
expenses have not been paid by another party which licenses technology from
M-Tech or its Affiliates.
3.4 Ownership. The patent applications filed and the patents
obtained by CancerVax pursuant to Section 3.1 hereof shall be owned solely by
M-Tech, assigned to M-Tech, deemed a part of Patent Rights, but shall
automatically be included as part of the M-Tech Technology licensed to CancerVax
hereunder.
3.5 M-Tech Right to Pursue Patent. If at any time during the term
of this Agreement, CancerVax's rights with respect to Patent Rights are
terminated, M-Tech shall have the right to take whatever action M-Tech deems
appropriate to obtain or maintain the corresponding patent protection at its own
expense. If M-Tech pursues patents under this Section 3.5, CancerVax agrees to
cooperate fully, including by providing, at no charge to M-Tech, all appropriate
technical data and executing all necessary legal documents to vest all of said
rights in M-Tech.
3.6 Infringement Actions.
3.6.1 Prosecution and Defense of Infringements. In order to
maintain the license granted hereunder in force, CancerVax shall prosecute any
and all infringements of any Patent Rights and shall defend all charges of
infringement arising as a result of the exercise of Patent Rights by CancerVax,
its Affiliates or sublicensees, unless otherwise agreed to between M-Tech and
CancerVax. CancerVax may enter into settlements, stipulated judgments or other
arrangements respecting such infringement, at its own expense, but only with the
prior written consent of M-Tech, which consent shall not be unreasonably
withheld. M-Tech shall permit any action to be brought in its name if required
by law. M-Tech agrees to provide reasonable assistance of a technical nature
which CancerVax may require in any litigation arising in accordance with the
provisions of this Section 3.6.1. In the event CancerVax fails to prosecute any
such infringement, CancerVax shall notify M-Tech in writing promptly and M-Tech
shall have the right to prosecute such infringement on its own behalf. Failure
on the part of CancerVax to prosecute any such infringement shall be grounds for
termination of the license
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granted to CancerVax hereunder, with respect to the country in which such
infringement occurs, at the option of M-Tech.
3.6.2 Allocation of Recovery. Any damages or other recovery
from an infringement action undertaken by CancerVax pursuant to Section 3.6.1
shall first be used to reimburse the Parties for the costs and expenses each has
incurred with respect to such action, and shall thereafter be allocated between
the Parties as follows: (i) fifteen percent (15%) to M-Tech and (ii) eighty-five
percent (85%) to CancerVax. If CancerVax fails to prosecute any such action to
completion, then any damages or other recovery net of the Parties' costs and
expenses incurred in such infringement action shall be the sole property of
M-Tech.
4. CancerVax Responsibilities.
4.1 Commercial Diligence. In order to maintain the license granted
hereunder in force, CancerVax shall use reasonable commercial efforts to develop
and commercialize M-Tech Technology and Patent Rights which are licensed
hereunder into commercially viable Licensed Products. CancerVax shall keep
M-Tech generally informed as to CancerVax's progress in such development and
commercialization, including the annual submission of Progress Reports pursuant
to Section 2.10.2 hereof. In the event that CancerVax decides not to pursue the
development of the M-Tech Technology, or if M-Tech exercises its termination
rights under this Section 4.1, all of the Patent Rights and M-Tech Technology
shall revert to M-Tech without any further obligation to CancerVax.
4.1.1 Investigational New Drug Application.
CancerVax will use reasonable commercial efforts to file an
IND for a Licensed Product based on the [***] cell line on or before December
31, 2005 and INDs for Licensed Products based on the [***] cell lines on or
before December 31, 2006, and to obtain approval of such INDs within one (1)
year of the date each such IND was submitted to the FDA or an equivalent foreign
regulatory agency.
In the event that CancerVax: (a) fails to file an IND for a
Licensed Product based on any of the three (3) cell lines included in the M-Tech
Technology by the respective IND Date for such cell line set forth in this
Section 4.1.1 and; (b) fails to obtain approval for such INDs within one (1)
year after submission of same to the FDA or any equivalent foreign regulatory
agency; and (c) fails to conduct clinical trials on any Licensed Products for
which such an IND has been approved by FDA or any equivalent foreign regulatory
agency for any reason other than negative pre-clinical results, M-Tech shall
have the right to terminate the license granted under Agreement with respect to
the cell line for which such obligations have not been met and CancerVax shall
be subject to a termination fee as follows: (i) U.S. One hundred thousand
dollars (US $100,000.00) with respect to the [***] cell line; and (ii) U.S.
Fifty thousand dollars (US $50,000.00) each with respect to the [***] cell
lines.
Alternatively, in the event that CancerVax fails to file an
IND for a Licensed Product based on any of the three (3) cell lines included in
the M-Tech Technology by the
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respective IND Date for such cell line set forth in this Section 4.1.1 based
upon negative pre-clinical results, M-Tech shall have the right to terminate
this Agreement with respect to the cell line for which such obligations have not
been met and CancerVax shall be subject to a termination fee as follows: (i)
U.S. Fifty thousand dollars (US$50,000.00) with respect to the [***] cell line;
and (ii) U.S. Twenty five thousand dollars each with respect to the [***] cell
lines.
The Parties hereto acknowledge and agree that filing of an IND
for a Licensed Product on or before the IND Date shall be evidence of compliance
by CancerVax with its commercial diligence obligations under this Agreement. In
the event that the license granted under this Agreement is terminated by M-Tech
in accordance with this Section 4.1.1 with respect to any of the cell lines for
which such obligations have not been met, the licenses granted hereunder with
respect to the other cell lines shall remain in full force and effect.
4.2 Licensed Product Development and Testing. CancerVax shall be
responsible for:
(a) performing all preclinical development of the Licensed
Products as required for filing INDs for such products with FDA and similar
filings with foreign regulatory agencies;
(b) initiating and performing human clinical studies of the
Licensed Products in the U.S., and the Target Markets, provided that, in the
sole discretion of CancerVax based upon the results of its preclinical testing,
such human clinical testing is warranted;
(c) developing and validating production methods used for
producing the Licensed Products as required for preclinical studies, human
clinical trials and for commercialization of the Licensed Products; and
(d) preparing and prosecuting all regulatory submissions required
for the development of the Licensed Products and to obtain approval to market
the Licensed Products in the U.S. and/or the Target Markets; provided that, in
the sole discretion of CancerVax based upon the results of its testing, seeking
such regulatory approval is warranted.
4.3 Indemnity. CancerVax hereby agrees to indemnify, defend and
hold harmless M-Tech and any and all co-owners of M-Tech Technology or Patent
Rights, and any Affiliate of M-Tech from and against any liability arising from
any product liability claim asserted by any party as to any Licensed Product.
Such indemnity and defense obligation shall apply to any product liability or
other claims, including without limitation, personal injury, death or property
damage, made by employees, subcontractors, sublicensees, or agents of CancerVax,
as well as any member of the general public. In the event any such claims,
demands or actions are made, CancerVax shall defend M-Tech at CancerVax's sole
expense by counsel selected by CancerVax, subject to approval by M-Tech, which
approval shall not be unreasonably withheld. From and after the time CancerVax
or any Affiliate or sublicensee begins clinical trials on any Licensed Product,
CancerVax, through commercial insurance, shall insure its activities in
connection with the work under this Agreement for comprehensive general
liability, at appropriate levels of coverage, which shall include at least Five
million dollars (US$5,000,000.00) for each
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occurrence, personal and advertising injury, product liability, and general
aggregate. It is understood, however, that the coverage and limits referred to
above shall not in any way limit the liability of CancerVax for its activities
in connection with the clinical use of the Licensed Products. CancerVax is not
required to insure its activities pertaining to product liability risks until it
begins testing Licensed Products in human subjects. CancerVax only needs
maintain at least One million dollars (US$1,000,000.00) of comprehensive general
liability insurance until it begins testing Licensed Products in human subjects.
CancerVax shall use its best efforts to have M-Tech named as additional insured
parties on any product liability insurance policies maintained by CancerVax, its
Affiliates and sublicensees applicable to Licensed Products.
4.4 Patent Marking. To the extent required by applicable law,
CancerVax shall mark all Licensed Products and/or their containers in accordance
with the applicable patent marking laws.
4.5 Use of Name. CancerVax agrees that, without the prior written
approval of M-Tech in M-Tech's sole discretion, it shall not use the name
"M-Tech Therapeutics, Inc.", "M-Tech", or any variation thereof in connection
with the advertising or sale of Licensed Products.
5. M-Tech Responsibilities.
5.1.1 Technology Transfer. M-Tech shall be responsible for:
(a) transferring to CancerVax all knowledge, know-how,
data, records and such other information as M-Tech may possess or develop in the
future related to the testing (preclinical and clinical), production,
purification and characterization of the M-Tech Technology, excluding, however
any and all methods and associated know-how used by M-Tech in the establishment
of human monoclonal antibody-producing cell lines;
(b) transferring to CancerVax the cell lines listed on
Exhibit A, and other biological materials useful or necessary in the testing,
production, purification, characterization or manufacture of the M-Tech
Technology; provided, however, that all reasonable expenses agreed to in advance
by CancerVax that are actually incurred by M-Tech and that are required to
accomplish the transfer of such materials shall be paid for or reimbursed to
M-Tech by CancerVax, including costs for material production, storage, moving
and related expenses.
(c) disclosing to CancerVax, all new developments and
inventions related to the M-Tech Technology, whether or not patentable, which
are subsequently conceived and/or reduced to practice by M-Tech and assist
CancerVax in taking all steps necessary to secure patent protection in the U.S.
and other countries in the name of M-Tech for any inventions to the maximum
extent possible, at CancerVax's cost, but for no additional consideration;
(d) providing 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 M-Tech
Technology; and
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(e) providing reasonable assistance to CancerVax, at
CancerVax's cost, in licensing from other third parties any additional
intellectual property, manufacturing, purification, analytical, testing or
related know-how related to the M-Tech Technology.
6. Representations and Warranties.
6.1 By M-Tech. M-Tech hereby represents and warrants to CancerVax
that:
(a) it has full right and power to enter into this Agreement;
(b) it has sufficient legal and/or beneficial title to the M-Tech
Technology to perform its obligations and to grant the rights contemplated under
this Agreement;
(c) to the best of its knowledge upon due inquiry, an informed
consent document was properly executed by each of the patients from whom cell
lines [***] were obtained;
(d) it has not entered, and will not enter, into any agreement
with any third party which is in conflict with the rights granted under this
Agreement, and has not taken and will not take any action that would in any way
prevent it from granting the rights contemplated under this Agreement;
(e) Exhibit A hereto contains a complete list of all of the Patent
Rights, and Exhibit B hereto contains a complete list of all Pre-Existing
Obligations;
(f) it is not aware of any communications alleging that it has
violated or, by fulfilling its obligations and granting the rights contemplated
under this Agreement, that it will violate any intellectual property rights of
any other person or entity; and
(g) it is not aware of any unauthorized use, infringement or
misappropriation of the M-Tech Technology.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, M-TECH AND ANY AND ALL
CO-OWNERS OF M-TECH TECHNOLOGY (A) MAKE NO EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO THE M-TECH TECHNOLOGY
OR ANY LICENSED PRODUCT, AND (B) SPECIFICALLY DISCLAIM ANY WARRANTY OR
REPRESENTATION REGARDING THE VALIDITY OR SCOPE OF THE PATENT RIGHTS OR THAT
ANYTHING MADE, USED, SOLD OR OTHERWISE DISPOSED OF UNDER ANY LICENSE GRANTED IN
THIS AGREEMENT IS OR WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS OR
OTHER RIGHTS OF THIRD PARTIES.
6.2 By CancerVax. CancerVax hereby represents and warrants to
M-Tech that:
(a) it has full right and power to enter into this Agreement;
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(b) it has not entered, and will not enter, into any agreement
with any third party which is in conflict with the rights granted to CancerVax,
its Affiliates and sublicensees under this Agreement;
(c) it is not aware of any unauthorized use, infringement or
misappropriation of the M-Tech Technology.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, CANCERVAX AND ITS
AFFILIATES MAKE NO EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE AS TO ANY LICENSED PRODUCT.
7. Interests in Intellectual Property Rights
7.1 Preservation of Title. M-Tech and any and all co-owners of
M-Tech Technology or Patent Rights shall retain full ownership and title to
M-Tech Technology, and Patent Rights licensed hereunder and shall use its
reasonable best efforts to preserve and maintain such full ownership and title,
subject to CancerVax fully performing all of its obligations under this
Agreement.
7.2 Interests of [***]. CancerVax and M-Tech acknowledge and agree
that their respective rights and obligations pursuant to this Agreement shall be
subject to M-Tech's obligations and the rights of [***] ("[***]"), if any,
including without limitation, the grant by M-Tech to [***] of a royalty-free,
fully paid, irrevocable, nontransferable license to make and use products and to
practice methods and processes to propagate and use certain of the M-Tech
Technology (defined as the "Original Materials and associated technology"
therein), for its noncommercial educational, research and clinical purposes.
Subject to appropriate confidentiality restrictions to be agreed upon between
the Parties, CancerVax agrees to provide M-Tech with relevant and timely
business and technical information, as required under Sections 7 and 8 of
Transfer Agreement No. [***] between [***] and an Affiliate of M-Tech, dated the
[***], and under Sections 9 and 10 of the License Agreement No. [***] between
[***] and an Affiliate of M-Tech, dated [***].
8. Right of First Refusal to Additional Human Monoclonal Antibodies.
M-Tech hereby grants to CancerVax a right of first refusal to negotiate
for the acquisition of additional human monoclonal antibody cell lines,
intellectual property and know-how developed and currently owned by or licensed
to M-Tech or its Affiliates, which M-Tech may disclose or transfer to CancerVax
without violating the Pre-Existing Obligations and which are not included in the
provisions of any agreement between CancerVax and any Affiliate of M-Tech of
even date herewith. CancerVax's right of first refusal will include any
therapeutic products derived therefrom, but will exclude, however, any and all
methods and/or associated know-how used by M-Tech or its Affiliates in the
establishment of human monoclonal antibody-producing cell lines. M-Tech will
provide CancerVax with written notice of such additional human
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monoclonal antibody cell lines, intellectual property, etc., as provided in
this Section 8. CancerVax will then have sixty (60) days to express its interest
in negotiating with M-Tech for such rights and to enter into a non-binding term
sheet with M-Tech related to same. Thereafter, CancerVax and M-Tech shall have
an additional sixty (60) days to finalize and execute a binding license
agreement covering said additional human monoclonal antibody cell lines,
intellectual property, etc. Should the Parties fail to enter into a non-binding
term sheet within the first sixty (60) day period, or after entering into such
term sheet, fail to enter into a binding license agreement within the next sixty
(60) day period, then CancerVax's right of first refusal with respect to the
noticed additional human monoclonal antibody cell lines, intellectual property,
etc., shall immediately terminate, and M-Tech shall be free to negotiate with
any other party with respect to the same without further obligation to
CancerVax. CancerVax's rights under this Section 8 will, however, exclude
M-Tech's existing cell line [***], and cell lines producing human monoclonal
antibodies that are primarily reactive to [***] and [***], respectively. Any and
all rights of first refusal provided in the Agreement shall terminate on
December 31, 2003, which termination date may be extended by mutually agreeable
terms and conditions.
9. Confidentiality and Publications.
9.1 Treatment of Confidential Information. The Parties agree that
during the term of this Agreement, and for a period of five (5) years after this
Agreement terminates, a Party receiving Confidential Information of the other
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 party without prior written
consent of the other Party and (iii) not use such Confidential Information for
any purpose except those permitted by this Agreement. Except as required by
applicable law, regulatory rule or administrative order, or in fulfillment of
its disclosure obligations to its legal or accounting advisors, existing or
potential investors, financing sources or regulatory agencies, neither CancerVax
nor M-Tech shall disclose to any third party the terms and conditions of this
Agreement without the prior written consent of the other Party hereto.
9.2 Publications. M-Tech shall have the right to publish or
present information related to the M-Tech Technology, provided such publication
or presentation (and any revisions thereto): (a) does not disclose Confidential
Information of CancerVax; and (b) is submitted to CancerVax at least thirty (30)
days prior to the date of submission of such proposed publication or
presentation; however, submission of any publication or presentation shall be
delayed for an additional forty-five (45) days to provide for filing of
appropriate patent applications for any potentially patentable subject matter to
be disclosed in such publication.
9.3 Publicity. Except as otherwise provided herein or required by
law or regulation, no party shall originate any publication, news release or
other public announcement, written or oral, whether in the public press,
stockholders' reports, or otherwise, relating to this Agreement or to any
sublicense 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.
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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10. Term and Termination.
10.1 Term. Unless terminated sooner in accordance with the terms
set forth herein, this Agreement, and the license granted under Section 2.2.1
hereof, shall terminate as provided in Section 2.7 hereof.
10.2 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;
(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 the other 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 10.2 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.
10.3 Termination Upon Bankruptcy or Insolvency. This Agreement may
be terminated by either Party giving written notice of termination to the other
Party upon the filing of bankruptcy of the other Party or the appointment of a
receiver of any of the other Party's assets, or the making by the other Party of
any assignment for the benefit of creditors, or the institution of any
proceedings against the other Party under any bankruptcy law. Termination shall
be effective upon the date specified in such notice.
10.4 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. Provided, however, that upon such expiration, each Party shall
be required to continue to abide by its non-disclosure obligations as described
in Section 9.1, CancerVax shall continue to abide by its obligation to indemnify
M-Tech and any and all co-owners of M-Tech Technology or Patent Rights as
described in Section 4.3, and the non-exclusive license to the Joint
Improvements granted to CancerVax in Section 2.2.2 hereof shall remain in full
force and effect.
10.5 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 in Section
2.2.1 hereof shall terminate; however, the non-exclusive license to the Joint
Improvements granted to CancerVax in Section 2.2.2 hereof shall remain in full
force and effect. Except as otherwise provided in Section 10.6 of this Agreement
with respect to work-in-progress, upon such termination, CancerVax shall have no
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further right to develop, manufacture or market any Licensed Product, or to
otherwise use any M-Tech Technology not otherwise includable therein. Upon any
such termination, CancerVax shall promptly return all materials, samples,
documents, information, and other materials which embody or disclose M-Tech
Technology not otherwise includable therein; provided, however, that CancerVax
shall not be obligated to provide M-Tech 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 9.1, and CancerVax shall
continue to abide by its obligations to indemnify M-Tech and any and all
co-owners of M-Tech Technology as described in Section 4.3.
10.6 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 M-Tech the royalties 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.
11. Assignment; Successors.
11.1 Assignment. Neither Party may assign or otherwise transfer its
rights or obligations under this Agreement without the prior written consent of
the other Party, such consent not to be unreasonably withheld, except that a
Party may assign or otherwise transfer its rights or obligations in whole or in
part without such consent (i) to an Affiliate of such Party, provided that no
such assignment shall relieve any Party as the primary obligor hereunder, or
(ii) to a third party in connection with the merger, consolidation, or sale of
all or substantially all of the assets of the assigning Party, or reorganization
affecting all or substantially all of the assets or voting control of the
assigning Party.
11.2 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 M-Tech and
CancerVax. Any such successor or assignee of shall expressly assume in writing
the performance of all the terms and conditions of this Agreement to be
performed by the assignor.
12. General Provisions.
12.1 Independent Contractors. The relationship between M-Tech and
CancerVax is that of independent contractors. M-Tech and CancerVax are not joint
venturers, partners, principal and agent, master and servant, employer or
employee, and have no other relationship other than independent contracting
Parties. M-Tech 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.
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12.2 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. 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.
12.2.1 Location. The location of the arbitration shall be in
the County of San Diego.
12.2.2 Selection of Arbitrators. The arbitration shall be
conducted by a panel of three 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 days, and the other Party fails to appoint its designated arbitrator
within ten days after receiving said written demand, then the arbitrator who has
already been designated shall appoint the other two arbitrators.
12.2.3 Discovery. Unless the Parties mutually agree in
writing to some additional and specific pre-hearing discovery, the only
pre-hearing discovery shall be (a) reasonably limited production of relevant and
non-privileged documents, and (b) 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 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.
12.2.4 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.
12.2.5 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 of
the three arbitrators appointed shall be binding upon the parties.
12.2.6 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
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by the arbitrators. Unless and until the arbitrators decide that one Party is to
pay for all (or a share) of such expenses, both Parties shall share equally in
the payment of the arbitrators' fees as and when billed by the arbitrators.
12.2.7 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, 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.
12.3 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 both Parties.
12.4 California Law. This Agreement shall be construed and enforced
in accordance with the laws of the State of California without regard to the
conflicts of laws principles thereof.
12.5 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.
12.6 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.
12.7 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.
12.8 Counterparts. The Agreement may be executed in any number of
counterparts, each of which will be deemed an original but which together shall
constitute a single instrument.
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12.9 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 M-Tech: M-Tech Therapeutics, Inc.
800 Silverado Street
Second Floor
La Jolla, California 92037
Fax No.: (858) 551-2440
and copy to: [***]
For CancerVax: CancerVax Corporation
2110 Rutherford Road
Carlsbad, California 92008
Attention: General Counsel
Fax No.: (760) 494-4282
Notice shall be deemed delivered upon the earlier of (i) when received, (ii)
three (3) days after deposit into the mail, or (iii) the date notice is sent via
telefax, telex or cable, (iv) the day immediately following delivery to
overnight courier (except Sunday and holidays).
12.10 Compliance with U.S. Laws. Nothing contained in this Agreement
shall require or permit M-Tech or CancerVax to do any act inconsistent with the
requirements of any United States law, regulation or executive order as the same
may be in effect from time to time.
12.11 Third Party Rights or Obligations. Except as otherwise
expressly provided in this Agreement, no provision of the Agreement will be
deemed or construed in any way to result in the creation of any rights or
obligations in any person or entity not a party to this Agreement.
12.12 Drafting Presumption. The Parties will acknowledge that the
Agreement has been agreed to by all Parties, that each Party has consulted with
attorneys with respect to the terms hereof and its Exhibits. No presumption will
be created against any Party hereto because of its role in drafting the
Agreement.
12.13 Force Majeure. Each of the Parties to the Agreement will be
excused from performance of its obligations thereunder in the event such
performance prevented by Force Majeure (as defined herein), provided that the
non-performing Party promptly notifies the other parties of such prevention.
Such excuse will be continued for so long as the condition
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constituting Force Majeure continues and the non-performing Party makes and
continues to make reasonable efforts to remove or overcome the condition. "Force
Majeure" shall mean any act of God, fire, casualty, flood, war, terrorism,
earthquake, strike, failure of public utilities, any act, exercise assertion or
requirement of any governmental authority, accident, epidemic, destruction of
facilities, or such other similar occurrences beyond the control of the Party
whose performance is affected.
12.14 Limitation of Liability. IN NO EVENT WILL ANY PARTY OR ITS
RESPECTIVE AFFILIATES AND SUBLICENSEES BE LIABLE FOR SPECIAL, EXEMPLARY,
CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT
LIABILITY OR OTHERWISE, EXCEPT TO THE EXTENT THAT SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY FROM SUCH DAMAGES CLAIMED BY THIRD PARTIES UNDER
SECTION 4.3 OF THE AGREEMENT.
12.15 Coordination of Agreements: If any provision of this License
Agreement is in conflict or is inconsistent with any provision of the Release
Agreement, the provisions of this License Agreement shall be controlling.
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IN WITNESS WHEREOF, the parties have executed this Agreement by their
duly authorized representatives as of the date set forth above.
M-TECH: CANCERVAX:
THE M-TECH THERAPEUTICS, INC. CANCERVAX CORPORATION
By: /s/ Dr. Reiko Irie By: /s/ David F. Hale
------------------------------------- -----------------------
Dr. Reiko Irie David F. Hale
President President and CEO
[SIGNATURE PAGE TO LICENSE AGREEMENT]
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EXHIBIT A
M-TECH TECHNOLOGY
[3 Pages of M-Tech Technology Deleted Pursuant to Confidential Treatment
Request]
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EXHIBIT B
PRE-EXISTING OBLIGATIONS
See attached letter, dated January 24, 2002, from Dr. Reiko Irie to Michael
White, PhD, Director, Technology Transfer Office, John Wayne Cancer Institute,
regarding human monoclonal antibody producing cell lines, [***] owned by an
Affiliate of M-Tech.
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omitted portions.
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EXHIBIT C
MUTUAL RELEASE AGREEMENT
This Mutual Release Agreement (the "Release Agreement") is entered into
and made effective as of this 4th day of October, 2002 (the "Effective Date"),
by and among, on one hand, Dr. Reiko F. Irie, an individual residing at 17624
Tramonto Drive, Pacific Palisades, California, 90272 ("Dr. Irie"), Human
Monoclonal International, Inc., a California corporation ("HMI") with offices
located at 17624 Tramonto Drive, Pacific Palisades, California, 90272, and
M-Tech Therapeutics, Inc., a California Corporation ("M-Tech") and wholly owned
subsidiary of HMI, located at 800 Silverado Street, 2nd Floor, La Jolla,
California, 92037, and on the other hand, CancerVax Corporation, a Delaware
corporation, with offices located at 2110 Rutherford Road, Carlsbad, California,
92008, and its Affiliates ("CancerVax"). Dr. Irie, HMI and M-Tech, on the one
hand, and CancerVax, on the other hand, are sometimes each hereinafter referred
to as a "Party" or, collectively, as "Parties" to this Release Agreement.
RECITALS
A. Dr. Irie is engaged in biomedical research including research relating to
the field of monoclonal antibodies, first at the University of California,
Los Angeles ("UCLA") between 1976 - 1992, and from 1992 to the present at
the John Wayne Cancer Institute ("JWCI").
B. HMI is engaged in the discovery, research., development and
commercialization of monoclonal antibodies for therapeutic and diagnostic
applications.
C. M-Tech is engaged in biomedical research, development and
commercialization of monoclonal antibodies.
D. CancerVax is engaged in the discovery, development and commercialization
of biological products for the treatment, prevention and control of
cancer.
E. CancerVax and M-Tech have of even date entered into that certain License
Agreement (the "CancerVax/M-Tech License Agreement"), whereby M-Tech has
licensed certain antibody technology to CancerVax, according to the terms
and conditions stated therein.
F. The Parties acknowledge that the 20 Cell Lines (as defined below in
Section 1.3) are owned by CancerVax and/or its Affiliates, subject to
certain royalty and other obligations to the Regents of the University of
California.
AGREEMENT
NOW, THEREFORE, in consideration of their mutual promises, covenants and
agreements set forth herein and other good and valuable consideration,
including, but not limited to, in the CancerVax/M-Tech License Agreement, Dr.
Irie, HMI, M-Tech and CancerVax hereby agree as follows:
1. Definitions. Capitalized terms shall have the meaning set forth below.
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1.1. Affiliate. The term "Affiliate" shall mean any entity which directly
or indirectly controls, is controlled by or is under common control with a party
hereto. 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 Antibodies. The term "Antibodies" shall mean monoclonal antibodies and
the cell lines from which the Antibodies are produced, either characterized or
uncharacterized, including but not limited to those cell lines and Antibodies
listed in Transfer Agreement No. M960924 between The Regents and an Affiliate of
M-Tech, dated the 11th of June, 1997 and the License Agreement No. R981110
between The Regents and an Affiliate of M-Tech, dated the 17th of January, 1999,
that have been developed by Dr. Irie, at UCLA or JWCI, HMI, M-Tech and their
respective Affiliates prior to the Effective Date, as evidenced by documentation
in Dr. Irie's possession as of the Effective Date, including:
(a) Antibodies that are modified or decorated with other molecules,
toxins, chemicals, isotopes and/or chemotherapeutic drugs;
(b) derivatives and fractions of the Antibodies, and derivatives and
fractions of Antibodies that are modified or decorated with other molecules,
toxins, chemicals, isotopes and/or chemotherapeutic drugs; and
(c) recombinant Antibodies, and recombinant Antibodies that are
modified or decorated with other molecules, toxins, chemicals, isotopes and/or
chemotherapeutic drugs.
1.3 20 Cell Lines. The term "20 Cell Lines" shall mean the twenty tumor
cell lines listed in Appendix A of this Release Agreement, including all
progeny, modified and unmodified derivatives, secretions and antigens thereof.
1.4 New Antibodies. The term "New Antibodies" shall mean any monoclonal
antibodies other than the Antibodies.
2. Releases.
2.1 CancerVax's Release. Subject to the provisions of Section 2.4 of
this Release Agreement, CancerVax and its Affiliates hereby release and forever
discharge Dr. Irie, HMI, M-Tech and each of their respective individual, joint
or mutual, past, present and future representatives, Affiliates, officers,
directors, agents, attorneys, stockholders, controlling persons, subsidiaries,
successors, assigns and sublicensees (individually, a "Releasee" and
collectively, "Releasees") from any and all claims, demands, proceedings, causes
of action, orders, obligations, contracts, agreements, debts and liabilities
whatsoever, whether known or unknown, suspected or unsuspected, both at law and
in equity, which CancerVax or any of its Affiliates now have, have ever had or
may hereafter have against the respective Releasees relating to Dr. Irie's,
HMI's, M-Tech's and their sublicensee's past, present and future use of the 20
Cell Lines: (a) as reagents in the non-commercial and commercial research,
testing, development, and manufacture of the Antibodies; and (b) as reagents in
the non-commercial and commercial development of new methods and new reagents by
the use of the Antibodies.
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Notwithstanding anything else in this Release Agreement to the contrary,
this release explicitly does not extend to other activities, including any use
of the 20 Cell Lines by Releasees:
(i) in any activities involving the research, testing, development,
or manufacture of vaccines;
(ii) in the sale of any product that incorporates any of the 20 Cell
Lines (including their progeny, derivatives, unmodified derivatives, or other
derivatives, unmodified subunits or products expressed by the 20 Cell Lines,
secreted or not, including all subclones of any of the unmodified 20 Cell Lines
and all products, purified or fractionated from any of the 20 Cell Lines or
their progeny); or
(iii) as reagents or otherwise for the research, testing,
development, or manufacture of any New Antibodies.
CancerVax and its Affiliates hereby irrevocably covenant to refrain from,
directly or indirectly, asserting any claim or demand, or commencing,
instituting or causing to be commenced, any proceeding of any kind against any
Releasee, based upon any matter purported to be released hereby in this Section
2.1. It is recognized by each of the Parties hereto that neither CancerVax nor
any other entity is obligated to provide, nor shall they provide, any of the 20
Cell Lines for any commercial purpose.
2.2 Dr. Irie's, HMI's and M-Tech's Release. Dr. Irie, HMI, M-Tech and
their respective Affiliates hereby release and forever discharge CancerVax, and
its individual, joint or mutual, past, present and future representatives,
Affiliates, officers, directors, agents, attorneys, stockholders, controlling
persons, subsidiaries, successors, assigns and sublicensees (individually, a
"Releasee" and collectively, "Releasees") from any and all claims, demands,
proceedings, causes of action, orders, obligations, contracts, agreements, debts
and liabilities whatsoever, whether known or unknown, suspected or unsuspected,
both at law and in equity, which Dr. Irie, HMI, M-Tech or any of their
respective Affiliates now have, have ever had or may hereafter have against the
respective Releasees arising contemporaneously with, prior to, and after the
Effective Date, including, without limitation, any rights to indemnification or
reimbursement from CancerVax or its Affiliates, whether pursuant to its
agreements, contracts or otherwise and whether or not relating to claims pending
on, or asserted after, the Effective Date. Dr. Irie, HMI, M-Tech and their
respective Affiliates hereby irrevocably covenant to refrain from, directly or
indirectly, asserting any claim or demand, or commencing, instituting or causing
to be commenced, any proceeding of any kind against any Releasee, based upon any
matter purported to be released hereby in this Section 2.2.
2.3 Exclusions from and Extent of Releases. Expressly excluded from the
releases set forth in Sections 2.1 and 2.2 are any and all claims, proceedings,
causes of action, orders, rights, obligations, contracts, agreements, debts and
liabilities whatsoever, related to the CancerVax/M-Tech License Agreement, and
other agreements referenced therein as exhibits to the respective agreements
("Third Party Agreements."). The Parties acknowledge that the releases set forth
in Section 2.1 and 2.2 do not include any release, express or implied, by an
entities or persons not a Party to this Release Agreement.
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2.4 Payments to The Regents of the University of California.
Notwithstanding any other provision of this Release Agreement to the contrary,
in the event that any payments are due to the Regents of the University of
California with respect to any use of the 20 Cell Lines by Dr. Irie, HMI, M-Tech
or any of their respective Affiliates or sublicensees, then Dr. Irie, HMI,
M-Tech, and any of their respective Affiliates and sublicensees shall be jointly
and severally responsible for such payments.
2.5 Rights to Antibodies. Except as expressly provided for in other
agreements between the Parties hereto, CancerVax shall not have any rights to
the Antibodies or any new methods or new reagents developed with the use of the
Antibodies by Dr. Irie, HMI, M-Tech, or their respective Affiliates or
sublicensees including, but not limited to, patent rights or rights in
inventions derived therefrom.
3. Representations and Warranties.
3.1 By Dr. Irie, HMI, M-Tech and Their Affiliates. Dr. Irie, HMI, M-Tech
and their respective Affiliates hereby represent and warrant to CancerVax that:
(a) each has the full right and power to enter into this Release
Agreement;
(b) each has not entered into any agreement with any third party
regarding the 20 Cell Lines and each has not transferred any of the 20 Cell
Lines to any third party;
(c) to each of its knowledge, all transfers of the 20 Cell Lines have been
authorized by either UCLA's or JWCI's representatives and not by Dr. Irie, HMI,
M-Tech or their respective Affiliates;
(d) each will use its best efforts to maintain the confidentiality of the
20 Cell Lines; the Parties acknowledge that certain disclosures to date of the
20 Cell Lines by Dr. Irie, HMI, M-Tech and their respective Affiliates have
included those: (i) by Dr. Irie while at UCLA made directly to UCLA researchers
for academic, educational or other non-commercial purposes; (ii) by Dr. Irie
while at JWCI to JWCI researchers at JWCI for academic, educational or other
non-commercial purposes; (iii) by Dr. Irie and her fellow scientists in their
publications in the scientific journals, book chapters, articles and issued
and/or pending patents, and their presentations to various public and private
scientific meetings, including meetings held with universalities, cancer
institutes, biotechnology companies and pharmaceutical companies; (iv) by Dr.
Irie to the Intellectual Property Office at UCLA and the Technology Transfer
Office at JWCI. The Parties acknowledge that some of these disclosures are
confidential; and by Dr. Irie, HMI, M-Tech or their respective Affiliates: (a)
to CancerVax or its Affiliates; (b) to Donald L. Morton, MD;
(e) each shall not enter into a written bailment, material transfer or
sublicensing agreement with a third party related to the 20 Cell Lines unless:
(i) such written bailment, material transfer or sublicensing agreements
expressly limit the use of any of the 20 Cell Lines by such third party to those
uses permitted under release given by CancerVax and its Affiliates in Section
2.1 hereof, and expressly exclude any use of any of the 20 Cell Lines which is
excluded
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under such release; and (ii) the name and address of each such bailee,
transferee or sublicensee, and a copy of the written bailment, material transfer
or sublicensing agreement shall be provided to CancerVax within 30 days of
execution of any such agreement;
(f) each has not and will not be involved with, and has not and will not
enter into an agreement with a third party regarding any use of the 20 Cell
Lines excluded under the release given by CancerVax and its Affiliates in
Section 2.1 hereof, other than those activities pursuant to an agreement or
collaboration with CancerVax or its Affiliates;
(g) aside from any of the disclosures and transfers set forth in Section
4.1(c and) above, each is not aware of any unauthorized use, infringement or
misappropriation of the 20 Cell Lines; and
(h) each shall not license, assign, quitclaim, sell, transfer or otherwise
grant any rights to any third party for the commercial development of any of the
Antibodies for which any of the 20 Cell Lines have been used either: (a) as a
reagent in the non-commercial and commercial research, testing, development, and
manufacture of the Antibodies; or (b) as a reagent in the non-commercial and
commercial development of new methods and new reagents by the use of the
Antibodies, unless a notice of such proposed license, assignment, quitclaim,
sale, transfer or grant of any rights shall be provided to CancerVax no less
than ninety (90) days in advance and, included with such notice, shall be
documentation reasonably acceptable to CancerVax evidencing the date of the
development of such Antibodies, which Antibody was transferred and which of the
20 Cell Lines was used in the development of said Antibody. Any transfer under
this Section involving Antibodies not developed by the use of the 20 Cell Lines
will not be subject to these disclosure requirements.
3.2 By CancerVax. CancerVax hereby represents and warrants to Dr. Irie,
HMI and M-Tech that it has full right and power to enter into this Release
Agreement.
4. Confidentiality.
4.1 Confidentiality of the Agreement. The Parties agree that the existence
and terms of this Release Agreement will remain confidential, except as provided
below. It is agreed that the respective Parties shall have the right to make
confidential statements to their attorneys and tax advisors, representatives of
the Regents of the University of California, sublicensees and to others as
required by law or regulation, about the terms of the Agreement. No other public
statements, including, but not limited to, speeches, lectures, publications,
press releases, advertisements, e-mails and postings on the Internet or World
Wide Web, shall be made by any Party concerning this Release Agreement or the
terms thereof other than mutually agreed upon statements.
4.2 Disclosure of Agreement. Each of the Parties may disclose this Release
Agreement under an agreement of confidentiality to any third party with whom
such Party enters into any confidential agreement by which the interests of such
Party is acquired by or merged with said third party.
5. General Provisions.
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5.1 Entire Agreement; Modifications. This Release 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 Release Agreement,
except by a written document which is signed by the Parties hereto.
5.2 Assignment. CancerVax may assign or otherwise transfer its rights and
obligations under this Release Agreement. None of Dr. Irie, HMI or M-Tech may
assign or otherwise transfer its rights or obligations under this Release
Agreement without the prior written consent of CancerVax, such consent not to be
unreasonably withheld, except to a third party in connection with the merger,
consolidation, or sale of substantially all of the assets of the assigning
Party, or reorganization affecting substantially all of the assets or voting
control of the assigning Party.
5.3 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 CancerVax, Dr. Irie, HMI and
M-Tech. Any such successor or assignee shall expressly assume in writing the
performance of all the terms and conditions of this Release Agreement to be
performed by the assignor.
5.4 California Law. This Release Agreement shall be construed and enforced
in accordance with the laws of the State of California without regard to the
conflicts of laws principles thereof.
5.5 Headings. The headings for each article and section in this Release
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.
5.6 Severability; Survival. Should any one or more of the provisions of
this Release Agreement be held invalid or unenforceable by a court of competent
jurisdiction, it shall be considered severed from this Release 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 Release Agreement may be realized. The following articles and
sections of this Release Agreement shall survive the expiration or termination
of this Release Agreement for any reason.
5.7 Counterparts. The Release Agreement may be executed in any number of
counterparts, each of which will be deemed an original but which together shall
constitute a single instrument.
5.8 Use of Agreement. It is specifically understood that this Release
Agreement may be plead as a full and complete defense to, and may be used as the
basis for an injunction (inadequate remedy at law being stipulated) against, any
action, suit, or other proceeding which may be instituted, prosecuted, or
attempted in breach of this Release Agreement, excepting only an action based on
an alleged breach of this Release Agreement.
5.9 Third Party Rights or Obligations. Except as otherwise expressly
provided in this Release Agreement, no provision of the Agreement will be deemed
or construed in any way to
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result in the creation of any rights or obligations in any person or entity not
a Party to this Release Agreement.
5.10 Drafting Presumption. The Parties will acknowledge that the Agreement
has been agreed to by all Parties, that each Party has consulted with attorneys
with respect to the terms hereof and its Exhibits. No presumption will be
created against any Party hereto because of its role in drafting the Agreement.
5.11 Advice of Counsel. The Parties hereto represent and declare that, in
executing this Release Agreement, they rely solely upon their own judgment,
belief, and knowledge, and the advice and recommendations of their own
independently selected counsel, concerning the nature, extent, and duration of
their rights and claims, and, except as otherwise expressly provided herein,
they have not been influenced to any extent whatsoever in executing the same by
any representations or statements made by any other Party hereto or by any
person representing any other Party hereto.
5.12 Coordination of Agreement: If any provision of this Release Agreement
is in conflict or is inconsistent with any provision of the License Agreement
dated October 4, 2002 by and between M-Tech and CancerVax, the provisions of
this License Agreement shall be controlling.
5.13 Notices. Any notices required by this Release Agreement shall be in
writing, shall specifically refer to this Release 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 Dr. Irie or HMI: Dr. Reiko Irie
17624 Tramonto Drive
Pacific Palisades, California 90272
Fax No.: _____________________
For M-Tech: M-Tech Therapeutics, Inc.
800 Silverado Street
Second Floor
La Jolla, California 92037
Fax No.: (858) 551-2440
and copy to: Thomas E. Jurgensen, Esq.
800 Silverado Street
Second Floor
La Jolla, California 92037
Fax No.: (858) 551-2440
For CancerVax: CancerVax Corporation
2110 Rutherford Road
Carlsbad, California 92008
Attention: General Counsel
Fax No.: (760) 494-4282
Notice shall be deemed delivered upon the earlier of (i) when received, (ii)
three (3) days after deposit into the mail, or (iii) the date notice is sent via
telefax, telex or cable, (iv) the day immediately following delivery to
overnight courier (except Sunday and holidays).
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IN WITNESS WHEREOF, the parties have executed this Release Agreement by their
duly authorized representatives as of the date set forth above.
HMI: CANCERVAX:
Human Monoclonal International, Inc. CANCERVAX CORPORATION
By:___________________________ By:___________________________
Dr. Reiko F. Irie David F. Hale
President President and CEO
M-TECH: DR. IRIE:
THE M-TECH THERAPEUTICS, INC.
By:___________________________ By:___________________________
Dr. Reiko F. Irie Dr. Reiko F. Irie
President
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APPENDIX A
20 CELL LINES
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*** 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.
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