CONFIDENTIAL TREATMENT REQUEST
* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.
LICENSE AGREEMENT (CAMPTOTHECIN)
BETWEEN
RESEARCH DEVELOPMENT FOUNDATION
AND
SUPERGEN, INC.
CONFIDENTIAL TREATMENT REQUEST
TABLE OF CONTENTS
PAGE
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ARTICLE I Definitions.............................................................................................2
ARTICLE II Grant of License.......................................................................................5
Scope of License.........................................................................................5
Right to Sublicense......................................................................................6
Reference and Review.....................................................................................6
ARTICLE III Patents and Improvements..............................................................................6
Patent Applications......................................................................................6
Patent Prosecution.......................................................................................6
Licensor Improvements....................................................................................7
Licensee Improvements; Reporting.........................................................................7
Licensee Improvements; Ownership.........................................................................7
Assistance...............................................................................................8
Improvements; Prosecution by Licensee....................................................................8
Inclusions...............................................................................................8
ARTICLE IV Royalties and Other Consideration......................................................................9
License Fee..............................................................................................9
Royalty.................................................................................................10
Term of Royalty Obligation..............................................................................10
Sublicenses.............................................................................................11
Deductions From Royalty Payments; Limitation on Deductions from Royalty Payments........................11
Milestone Payments......................................................................................12
Marketing Arrangements..................................................................................12
Conditions..............................................................................................12
ARTICLE V Payment and Reports....................................................................................13
Notice of Commercial Sale...............................................................................13
Payments and Reports....................................................................................13
U.S. Dollars............................................................................................13
Progress Reports........................................................................................13
Report on Termination...................................................................................14
Books and Records.......................................................................................14
Delinquent Payments.....................................................................................15
ARTICLE VI Effort to Commercialize...............................................................................15
Commercialization Obligation............................................................................15
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ARTICLE VII Protection of Patents................................................................................16
Protection..............................................................................................16
Notice of Infringement; Third Party Infringement........................................................17
Notice of Infringement; Claim of Licensee Infringement..................................................18
Assistance..............................................................................................18
ARTICLE VIII Disclaimer of Liability and/or Warranty.............................................................19
No Warranty.............................................................................................19
No Damages..............................................................................................20
No Warranty of Quality or Usefulness....................................................................20
Indemnification.........................................................................................20
Insurance...............................................................................................21
ARTICLE IX Term and Termination..................................................................................22
Term....................................................................................................22
Termination for Cause; Insolvency.......................................................................22
Default.................................................................................................22
Termination Upon Notice.................................................................................23
Discontinuance of Commercialization.....................................................................24
Provisions Surviving Termination........................................................................24
ARTICLE X Representations and Warranties.........................................................................24
Warranty to Title.......................................................................................24
No Other Information....................................................................................25
Power and Authority.....................................................................................25
Compliance with Laws....................................................................................25
ARTICLE XI Agency/Partnership/Use of Name........................................................................26
No Agency...............................................................................................26
No Partnership..........................................................................................26
Prohibition Against Use of Name.........................................................................26
ARTICLE XII Marking..............................................................................................27
ARTICLE XIII Nondisclosure of Confidential Information...........................................................27
Additional Permitted Disclosures........................................................................28
Non-Disclosure..........................................................................................29
ARTICLE XIV Miscellaneous........................................................................................30
Captions................................................................................................30
Notices.................................................................................................30
Assignment..............................................................................................31
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No Waiver...............................................................................................31
Choice of Law and Jurisdiction..........................................................................31
Severability............................................................................................31
Further Acts............................................................................................32
Entire Agreement........................................................................................32
Successors and Assigns..................................................................................32
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RESEARCH DEVELOPMENT FOUNDATION
LICENSE AGREEMENT
This License Agreement (hereinafter referred to as "Agreement") is made
and entered into as of the 15th day of November, 1999 (the "Effective Date" of
this Agreement), by and between RESEARCH DEVELOPMENT FOUNDATION (hereinafter
referred to as "Licensor"), a Nevada nonprofit corporation having its office at
000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxxxxx, 00000;
AND
SUPERGEN, INC. (hereinafter referred to as "Licensee"), a Delaware corporation
having an office at Xxx Xxxxxxx Xxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx, 00000.
WITNESSETH:
WHEREAS, Licensor is a nonprofit organization exempt from taxation
under Section 501(c)(3) of the Internal Revenue Code of 1986;
WHEREAS, Licensor is the owner of certain inventions, discoveries, and
know-how comprising certain Proprietary Property (as hereinafter defined);
WHEREAS, Licensor is the owner of all the right, title and interest in
and to said Proprietary Property and has determined that the grant of a license
to Licensee is the only practicable manner in which the Proprietary Property can
be utilized to benefit the public;
WHEREAS, Licensor has filed or intends to file for patents and/or other
protection therefor in the countries listed in Exhibit 2 hereto;
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WHEREAS, Licensee desires to obtain an exclusive, world-wide license
from Licensor as described herein to produce, have produced, make, have made,
manufacture, have manufactured, use, sell, rent and/or lease (hereafter referred
to as "make, use or sell") methods, processes, or products of Licensor's
Proprietary Property; and
WHEREAS, Xxxxxxx Foundation for Research ("Xxxxxxx"), Licensor and
Licensee have entered into a Research Agreement (Camptothecin) of even date
herewith whereby Xxxxxxx will conduct research in the field of interest relating
to 9-Nitrocamptothecin (hereafter the "Research Agreement"), which Research
Agreement is incorporated by reference herein for all purposes;
NOW, THEREFORE, in consideration of the above premises and the
covenants herein, the parties agree as follows:
ARTICLE I
DEFINITIONS
-----------
As used in this Agreement, the following terms shall have the following
respective meanings:
1.1 The term "Proprietary Property" shall mean and include all Patent
Rights described in Exhibit 1 hereto and Know-How;
1.2 The term "Patent Rights" shall mean any pending United States
or foreign patent applications and issued patents now or hereafter owned or
controlled by, or assigned to, Licensor which cover the Proprietary Property
and any divisions, substitutions, continuations and continuations-in-part
based thereon, any reissues,
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reexaminations, patents of addition or importation, or other extensions
thereof.
1.3 The term "Know-How" shall mean all information, data, know-how,
processes, materials, procedures, compositions, devices, protocols, designs,
specifications, techniques, software, methods, and any clinical diagnostic and
regulatory information or filings or other subject matter necessary or useful
for the practice of inventions covered by the Patent Rights or Licensor
Improvements which is owned by Licensor. Know-How specifically includes existing
data and/or regulatory filings related to the Patent Rights, made or contributed
to or by Licensor or an Other Corporation (as defined herein), or Xxxxxx Xxxxxx,
M.D.
1.4 The term "Licensed Proprietary Property" shall mean and include
the Patent Rights and Know-How which are licensed hereunder to Licensee.
1.5 The term "Product" shall mean a product or portion of a product
that embodies an invention claimed, or which is specifically intended to be used
to practice a method or process, within the Licensed Proprietary Property and
which is made, used or sold by or for Licensee (or its Affiliates or
sublicensees).
1.6 The term "Improvements" shall mean any improvement and/or
modification of the Licensed Proprietary Property, wherein aerosol droplets
contain one or more liposome particles.
1.7 The term "Affiliate" shall mean any present or future companies,
corporations, partnerships, joint ventures, business trusts or other business
entities organized under the laws of any nation (a) with respect to which: (i)
at least fifty percent (50%) in value of the total equity interests, (ii) at
least fifty percent (50%) of the total
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combined voting power of all classes of shares entitled to vote, or (iii) at
least fifty percent (50%) of the profits interest in the case of a partnership,
joint venture or other non-stock entity, is directly or indirectly under the
control of Licensee, or (b) with respect to which Licensee has effective
control, directly or indirectly. "Control" shall mean the possession of the
power to direct or cause the direction of the management and the policies of an
entity, whether through an ownership interest or by contract or otherwise. The
term "Licensee" wherever used herein shall include any Affiliate of Licensee.
1.8 The term "Gross Revenues" shall mean the total amount received
from third parties for the use or sale of Products less:
(a) usual trade, cash and quantity credits, discounts,
refunds or government rebates;
(b) amounts for claims, allowances or credits for
returns, retroactive price reductions or chargebacks;
(c) special packaging charges and handling fees, and
prepaid freight, sales taxes, duties and other
governmental charges (including value added tax)
imposed directly on the seller with respect to such
sales; and
(d) credits for goods returned (not to exceed the
original billing or invoice amount).
No other allowance or deduction shall be made by whatever name
known.
1.9 The terms "commercialize" and "commercialization" shall mean the
making, using, selling, or licensing by Licensee of the Product under such
circumstances as may be
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permitted by applicable international, federal, and state laws and regulations.
1.10 The term "Field of Use" shall mean the applications described in
Exhibit 1A hereto.
1.11 The term "Valid Claim" shall mean a claim of an issued and
unexpired patent or a claim of a pending patent application which has not been
held unpatentable, invalid or unenforceable by a court or other government
agency of competent jurisdiction and has not been admitted to be invalid or
unenforceable through reissue, re-examination, disclaimer or otherwise;
provided, however, that if any holding of invalidity, unenforceability or
unpatentability is later reversed by a court or agency with overriding
authority, the relevant claim shall be reinstated as a Valid Claim hereunder
with respect to sales made after the date of such reversal. Notwithstanding the
foregoing provisions of this Section 1.11, if a claim of a pending patent
application has not issued as a claim of an issued patent within five (5) years
after the date from which such claim takes priority, such pending claim shall
not be a Valid Claim for purposes of this Agreement unless and until the patent
is issued including such claim.
1.12 The term "Final Report" shall mean a report by a principal
investigator who has conducted a completed human clinical trial on a Product
wherein the report provides primary and summary data and results from the
completed human clinical trial on the Product.
ARTICLE II
GRANT OF LICENSE
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2.1 SCOPE OF LICENSE. Licensor hereby grants and Licensee hereby
accepts a worldwide, exclusive license under the Licensed Proprietary Property
to make, use or sell Products for the Field of Use. Licensor shall not license
any other party rights to deliver camptothecin or analogues thereof, alone or in
combination with another drug, in liposomes, lipid complexes or other liposome
particles, to the respiratory tract via aerosol droplets.
2.2 RIGHT TO SUBLICENSE. Licensor hereby grants and Licensee hereby
accepts the right to grant sublicenses to others within the scope of and under
the terms and conditions herein set forth. Licensee shall give written notice of
such sublicenses to Licensor.
2.3 REFERENCE AND REVIEW. Licensee will also have the right to review
and reference the Know-How in any application or filing relating to the
Proprietary Property with any governmental or regulatory authority before, on,
or after the Effective Date and that was, is, or will be made or contributed to
by Licensor, an Other Corporation (as defined herein), or Xxxxxx Xxxxxx, M.D.
ARTICLE III
PATENTS AND IMPROVEMENTS
------------------------
3.1 PATENT APPLICATIONS. Licensor agrees, at its own expense, to
timely file patent applications relating to the Proprietary Property in the
countries listed on Exhibit 2 hereto with regard to the Proprietary Property
listed in Exhibit 1 as of the Effective Date and with regard to Licensor
Improvements as set forth in Section 3.3.
3.2 PATENT PROSECUTION. Licensor further agrees to use its best
efforts to
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prosecute such patent applications and to maintain any patents issued thereon.
Notwithstanding the foregoing sentence, in the event that Licensor within its
sole judgment and discretion determines that prosecution or maintenance of a
patent in a particular country is not economically viable or otherwise feasible,
Licensor shall promptly notify Licensee of Licensor's intention to abandon such
patent application or patent. Licensor shall not otherwise abandon a patent or
patent application within the Patent Rights. Upon receipt of such notice,
Licensee, in its sole discretion, may elect to assume responsibility (and to pay
associated fees and expenses generated after Licensee assumes such
responsibility) with respect to a patent application or patent which Licensor
intends to abandon. The notice shall be provided sufficiently in advance of any
deadlines or due dates such that Licensee has a reasonable time within which to
assume responsibility and comply with the deadlines or due dates. Licensee may,
in its sole discretion, abandon any patent application or patent for which it
has previously assumed responsibility and will not be liable to Licensor in any
way for such abandonment.
3.3 LICENSOR IMPROVEMENTS. Licensor agrees to make available promptly
to Licensee during the term of this Agreement any Improvements now or hereafter
found, owned, or controlled by Licensor, and to submit to Licensee all available
Know-How pertaining thereto. Such Improvements in or to the Licensed Proprietary
Property and the corresponding rights throughout the world in patents or
copyrights shall be the property of Licensor, and shall be included in the
Licensed Proprietary Property licensed to Licensee subject to all of the terms
and conditions set forth in this Agreement.
3.4 LICENSEE IMPROVEMENTS; REPORTING. Licensee shall promptly submit
to
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Licensor during the term of this Agreement all available information and
Know-How on any Improvements, whether patentable, copyrightable or not, now or
hereafter found, discovered, invented, owned, or controlled by Licensee.
3.5 LICENSEE IMPROVEMENTS; OWNERSHIP. Any Improvements, whether
patentable, copyrightable or not, now or hereafter made and found by agents or
employees of Licensee either independently of agents or employees of Licensor
(or an "Other Corporation"), or jointly with others, shall be owned by Licensor
and shall be considered as part of the Licensed Proprietary Property. The
world-wide rights in the corresponding patents, patent applications, copyrights
and/or know-how shall be the property of Licensor subject to all the terms and
conditions of this Agreement, but licensed hereunder to Licensee by Licensor.
Licensee agrees to do all things necessary and required to vest in Licensor all
right, title and interest in and to any such Improvements.
3.6 ASSISTANCE. If patentable or otherwise protectable Improvements
are now or hereafter made and found by agents or employees of Licensee or
Licensor, either independently or jointly with others, and Licensor or Licensee
considers it desirable to obtain patent, copyright or other protection thereon,
the other party agrees to cooperate fully and to do all proper things necessary
or desirable to obtain and maintain patent, copyright or other protection
therefor throughout the world. Upon request, each party agrees to provide
reasonable technical assistance and advice for purposes of filing and
prosecuting patent applications and engaging in opposition, interference and
enforcement proceedings with respect to patent applications and patents within
the Patent Rights or for Improvements.
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3.7 IMPROVEMENTS; PROSECUTION BY LICENSEE. Notwithstanding the
provisions in Section 3.6 above, if Licensor fails to file an application for
patent or other protection therefor within six (6) months after receipt of a
written request from Licensee to do so, Licensor shall be deemed to have
consented to Licensee obtaining and maintaining the necessary protection
therefor at Licensee's expense.
3.8 INCLUSIONS. If either Licensor or Licensee files patent
applications or otherwise obtains patent rights or copyrights which relate to
the Licensed Proprietary Property, such patent application, patent rights or
copyrights shall be included in the Licensed Proprietary Property, and Licensee
shall have a license therefor under the terms and conditions set forth in this
Agreement.
ARTICLE IV
ROYALTIES AND OTHER CONSIDERATION
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4.1 LICENSE FEE. Upon Licensee's execution of this Agreement,
Licensee shall pay Licensor an up-front non-refundable license fee consisting of
[ * ] payable in shares of and by transferring to Licensor shares of the common
stock of SuperGen, Inc. Licensee guarantees, as described herein, the value of
such shares to be no less than such dollar amount (the "Guaranteed Value") on
the one (1) year anniversary of the date on which the shares are transferred to
Licensor (hereafter the "Anniversary Date"). If, during the thirty (30) days
preceding the Anniversary Date (or the next trading date if the Anniversary Date
is not a trading date), the common stock of Licensee has not traded on a public
stock exchange for an average price resulting in such shares being worth on
average at least the Guaranteed Value, then within thirty (30) days Licensee
will pay to Licensor a sum in cash (or, at Licensor's option, in the equivalent
value of additional unrestricted shares of the common stock of SuperGen, Inc.)
equal to the difference between (a) the Guaranteed Value and (b) the average
price at which the common stock of SuperGen, Inc. traded publicly during the
thirty (30) days preceding the Anniversary Date multiplied by the number of
shares transferred as the up-front non-refundable license fee under this Section
4.1. Any shares provided to Licensor will not be sold for at least one (1) year
following the Anniversary Date, and no more than three thousand (3,000) of the
shares shall be sold on any one trading date.
4.2 ROYALTY. Licensee shall pay Licensor during the term of this
Agreement an earned royalty of [ * ] on Gross Revenues. Only one (1) royalty
shall be payable on a Product, regardless of the number of licensed applications
and licensed patents of the Licensed Proprietary Property under which such
Product has been manufactured, used or
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sold. In the event that a Product is sold in combination as a single product
with another product ("Combination Product"), active component or service (which
product, component or service is not a portion of the Product) and whose sale
and use are not covered by a Valid Claim of the Product in the country for which
the combination product is sold, Gross Revenues from such sales for purposes of
calculating the amounts due under this Agreement shall be calculated by
multiplying the Gross Revenues of that combination by the fraction A/(A+B),
where A is the gross selling price of the Product sold separately and B is the
gross selling price of the other product, active component or service sold
separately. In the event that no such separate sales are made by Licensee or its
Sublicensee, Gross Revenues for royalty determination shall be reasonably
allocated between the Product and such other product, active component or
service, based upon their relative importance and proprietary protection.
Without limitation, liposomal compounds, camptothecin and analogues thereof, and
aerosol containers (nebulizers) are deemed to be portions of the Product.
4.3 TERM OF ROYALTY OBLIGATION. Royalty payments shall be paid on the
Products commencing on the Effective Date, and unless earlier terminated as
provided herein, shall continue on a country-by-country and Product-by-Product
basis until there are no remaining royalty payment obligations in a country, at
which time the Agreement shall expire in its entirety in such country. Royalty
payments shall cease for any patent which has been declared invalid or
unenforceable by a final determination or judgment, or if this Agreement is
terminated as hereinafter specified and provided.
4.4 SUBLICENSES. Licensee will pay to Licensor [ * ] of all
consideration
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(including, but not limited to, royalties, minimum royalties, up-front payments,
marketing, distribution, franchise, option, license or documentation fees, bonus
and milestone payments, license maintenance fees, and equity-related securities)
received from sublicensees of the Licensed Proprietary Property or the amount of
royalty Licensee would have owed pursuant to Section 4.2 had it engaged in the
same licensed conduct as said sublicensees, whichever is greater, as determined
on a quarterly basis. Notwithstanding the above, it is understood and agreed
that Licensor shall not be entitled to any share of amounts received by Licensee
for pilot studies, research and development, the license or sublicense of any
intellectual property other than the Licensed Proprietary Property,
reimbursement for patent or other expenses, or as consideration for equity or
debt of Licensee.
4.5 DEDUCTIONS FROM ROYALTY PAYMENTS; LIMITATION ON DEDUCTIONS FROM
ROYALTY PAYMENTS. If Licensee or its Sublicensee is required to pay a third
party under a Valid Claim with respect to the third party's intellectual
property or technology in order to make, use or sell a Product, Licensee may
deduct such amount from royalties due to Licensor for such Product.
Notwithstanding the foregoing provisions of this Section 4.5, wherever this
Agreement provides that Licensee may deduct expenses, payments or other amounts
from royalties payable to Licensor, (a) such deduction shall be applied only
against royalties payable from the territory with respect to which such
deduction arose, and (b) such deduction shall be prorated over such time as is
necessary to assure that the royalties payable to Licensor from such territory
in any period shall not be reduced by more than fifty percent (50%) of the
amount that otherwise would be due Licensor
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pursuant to this Agreement.
4.6 MILESTONE PAYMENTS. In addition to the up-front license fee and
royalties required under this Article IV, Licensee shall make milestone payments
to Licensor as set forth in Exhibit 3 hereto. Such payments shall be made in
common stock of Licensee in the amounts recited in Exhibit 3 and shall be
transferred to Licensor within thirty (30) days of occurrence of each of the
events indicated on such exhibit. Such common stock will not be sold for at
least one (1) year following the date on which the stock is transferred to
Licensor, and no more than three thousand (3,000) of the shares shall be sold on
any one trading date. Licensee guarantees the value of such shares to be the
Guaranteed Value calculated in the same manner as set forth in Section 4.1 of
this Agreement.
4.7 MARKETING ARRANGEMENTS. Where Products are marketed by an entity
other than Licensee under any type of commercial arrangement (including, without
limitation, a sublicense, joint venture, distributorship, or collaboration
agreement), the sales of the Products by such entity shall be used in
calculating Gross Revenues for purposes of determining royalties payable to
Licensor hereunder.
4.8 CONDITIONS. The obligations of Licensee under this License
Agreement are conditioned on Licensee's satisfaction in its sole discretion at
or prior to the date this License Agreement is executed with the results of its
due diligence with respect to the business, operations, affairs, properties,
assets, liabilities, obligations, profits and condition (financial or otherwise)
of Licensor; provided that compliance with any such conditions or parts thereof
may be waived in writing by Licensee. Licensor agrees to provide Licensee with
any information, including clinical or laboratory data or regulatory
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filings, that Licensor requests as part of the due diligence performed under
this Section 4.8.
ARTICLE V
PAYMENT AND REPORTS
5.1 NOTICE OF COMMERCIAL SALE. Licensee shall notify Licensor, in
writing, within thirty (30) days of the date of the first commercial making,
using or selling of Products.
5.2 PAYMENTS AND REPORTS. Licensee agrees that Licensee shall provide
within sixty (60) days after the end of each quarter of each calendar year:
(a) payment of amounts due to Licensor pursuant to this
Agreement, including, but not limited to, amounts
pursuant to Articles IV and VI; and
(b) a report summarizing the information and basis on
which such amounts have been calculated.
5.3 U.S. DOLLARS. All amounts payable in cash by Licensee shall be
paid in U.S. Dollars. Conversion from currencies other than U.S. Dollars shall
be at the rate of exchange used by Licensee for its general accounting purposes,
consistent with generally accepted accounting principles.
5.4 PROGRESS REPORTS. Until such time as earned royalties become
payable pursuant to this Agreement, Licensee agrees to make an annual report to
Licensor on each annual anniversary of the Effective Date covering Licensee's
progress during the previous year toward research, development and
commercialization.
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5.5 REPORT ON TERMINATION. Licensee also agrees to make a written
report to Licensor within ninety (90) days after the termination of this
Agreement, stating in such report the royalties payable hereunder and the basis
therefor not previously reported to Licensor. Licensee shall also continue to
make annual reports pursuant to the provisions of this Agreement covering
making, using or selling of Products after termination thereof, such as the
selling of stock on hand at termination which is specifically contemplated by
this Agreement and the applicable earned royalties hereunder, until such time as
all such makings, uses or sales shall have terminated. Concurrent with the
submittal of each post-termination report, Licensee shall pay Licensor all
applicable royalties.
5.6 BOOKS AND RECORDS. Licensee shall keep accurate books and records
with respect to the Products and/or Licensed Proprietary Property sufficient to
enable the calculation of royalties payable hereunder to be verified. Upon
thirty (30) days prior notice to Licensee, independent accountants selected by
Licensor, reasonably acceptable to Licensee, after entering into a
confidentiality agreement with Licensee, may have access to the books and
records of Licensee to conduct a review or audit once per calendar year, for the
sole purpose of verifying the accuracy of Licensee's payments and compliance
with this Agreement. The accounting firm shall report to Licensor only whether
there has been a royalty underpayment and, if so, the amount thereof. Such
access shall be permitted during Licensee's normal business hours during the
term of this Agreement and for three (3) years after the period to which the
audit pertains. Any such inspection or audit shall be at Licensor's expense;
provided that in the event the examination or audit results in a discrepancy in
the correctness of the payments due under this Agreement in an amount in
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excess of five percent (5%) of the payments due Licensor for any single quarter
audited, Licensee shall pay any and all costs or fees associated with such
examination or audit. Neither such right to review or audit nor Licensor's right
to receive any such underpayment shall be affected by any statement to the
contrary appearing on checks or otherwise, unless such statements appear in a
letter, signed by the party having such right and delivered to the other party,
expressly waiving such right. Notwithstanding the foregoing, Licensor may
require Licensee to furnish any other information reasonably requested to enable
Licensor to evaluate Licensee's performance under this Agreement.
5.7 DELINQUENT PAYMENTS. Payments provided for in this Agreement
shall, when overdue, bear interest at the then existing prime rate at Citibank
of New York (or its successor) plus four percent (4%) per annum until paid, but
in no event shall such interest exceed the usury limit, if any, as may exist
from time to time in the State of Nevada.
ARTICLE VI
EFFORT TO COMMERCIALIZE
6.1 COMMERCIALIZATION OBLIGATION. Licensee shall undertake to use
commercially reasonable efforts with regard to commercialization of the
Products.
6.2 MINIMUM ROYALTIES. Licensee shall pay to Licensor within ninety
(90) days after the date specified at least the following amounts of minimum
royalties within the time periods specified:
(a) on or before the third anniversary of the Effective
Date, at least [ * ].
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(b) on or before the fourth anniversary of the Effective
Date, at least [ * ].
(c) on or before the fifth anniversary of the Effective
Date, at least [ * ].
(d) on or before each succeeding anniversary of the
Effective Date, at least [ * ].
Minimum royalties paid in excess of earned royalties in a given
year shall not be creditable to earned royalties for future years. Minimum
royalties paid under this Section 6.2 may, at Licensee's option, be paid in
shares of the common stock of Licensee. Common stock transferred under this
Section 6.2 will not be sold for at least one (1) year following the date on
which the stock is transferred to Licensor, and no more than three thousand
(3,000) of the shares shall be sold on any one trading date. Licensee guarantees
the value of such shares to be the Guaranteed Value calculated in the same
manner as set forth in Section 4.1 of this Agreement.
ARTICLE VII
PROTECTION OF PATENTS
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7.1 PROTECTION. Licensor agrees, where economically justified and
within reasonable limits, to protect the Licensed Proprietary Property from
infringement or misappropriation by third parties in the Field of Use and to
prosecute such infringers or defendants, but the decision to undertake such
protection shall be in the sole discretion of Licensor, and Licensor's decision
as to whether any such action shall be taken by it shall be accepted by
Licensee. In the event that Licensor shall recover profits and/or damages from
said infringer or defendant in the Field of Use, Licensor agrees to turn over to
Licensee twenty-five percent (25%) of any amounts paid to it by said infringer
or defendant after deducting any of its expenses, including costs and legal fees
incurred in such litigation. Each party agrees to cooperate fully with the other
party in protection of the Licensed Proprietary Property, including by joining
as a party to any proceeding if required by applicable law.
7.2 NOTICE OF INFRINGEMENT; THIRD PARTY INFRINGEMENT. Licensor and
Licensee shall each give immediate written notice to the other of any
infringement of a Patent Right or misappropriation of Know-How or Improvements
by any third party in the Field of Use as may come to its knowledge.
Notwithstanding Section 7.1, if Licensor has not within six (6) months from the
date on which it is notified or otherwise becomes aware of an infringement or
misappropriation of the Licensed Proprietary Property in the Field of Use either
terminated such infringement or initiated legal action against the infringer or
defendant, it shall, upon written request of Licensee, grant to Licensee the
right to prosecute an action against the infringer or defendant at Licensee's
expense. Licensor agrees, in the event that Licensee cannot prosecute such
infringement or misappropriation
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in its own name, to sign and give to Licensee, as soon as practicable, all
necessary documents in order for Licensee to prosecute at Licensee's expense but
in the name of Licensor, such infringement or misappropriation. Licensee shall
be entitled to deduct all of its expenses, including costs and legal fees
incurred in bringing and prosecuting such infringement or misappropriation
action, from royalties due Licensor with respect to the country in which such
action is prosecuted after commencement of such infringement or misappropriation
action. In the event Licensee desires to settle or compromise such suit or
action in a manner that may adversely impact Licensor or Licensed Proprietary
Property, Licensee shall not so settle or compromise such suit or action without
the prior written consent of Licensor. In the event Licensee shall recover
profits and/or damages from said infringer or defendant, Licensee agrees to pay
to Licensor twenty-five percent (25%) of any amounts paid to it by said
infringer or defendant after deducting any of its expenses, including costs and
legal fees incurred in such litigation.
7.3 NOTICE OF INFRINGEMENT; CLAIM OF LICENSEE INFRINGEMENT. Licensee
shall promptly advise Licensor in writing of any notice or claim of any
infringement and of the commencement against it of any suit or action for
infringement of a third party patent made or brought against Licensee and based
upon the use hereunder by Licensee of the Licensed Proprietary Property.
Licensee shall have the right either to:
(a) request that Licensor enter into negotiations with
such third party to obtain rights for Licensee under
the third party patent; or
(b) request that Licensor defend such suit or action at
Licensor's expense.
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7.4 ASSISTANCE. Licensor is neither obligated to enter into
negotiations with such third party to obtain rights for Licensee under the third
party patent nor obligated to defend such suit or action. If Licensor, at its
sole discretion, elects to enter into negotiations with such third party to
obtain rights for Licensee under the third party patent or if Licensor, at its
sole discretion, elects to undertake at its own expense the defense of any such
suit or action to the extent that the alleged infringement is based upon such
use hereunder of the Licensed Proprietary Property, Licensee shall render to
Licensor all reasonable assistance that may be required by Licensor in the
negotiations or in the defense of such suit or action. Licensor has the primary
right to control the defense of any such suit or action by counsel of its own
choice, and Licensee shall have the right, at its own expense, to be represented
in any such suit or action in respect of which Licensee is a defendant by
counsel of its own choice, subject to Licensor's right of control.
Notwithstanding the foregoing, if Licensor has not within ninety (90) days (or
such lesser period of time as is necessary to avoid entry of a default judgment
against Licensor or Licensee) from the date of receipt of a request from
Licensee under Section 7.3 either entered into negotiations with such third
party to obtain rights for Licensee under the third party patent or initiated
legal action to defend such suit, it shall, upon written request of Licensee,
grant to Licensee the right to enter such negotiations or defend such suit.
Licensee shall be entitled to deduct all its expenses, including attorneys' fees
and specifically including costs and legal fees incurred in entering into such
negotiations or defending such suit from royalties due Licensor after
commencement of such action. Licensee shall not settle or compromise any such
suit or action without the prior written
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consent of Licensor, which consent shall not be unreasonably withheld.
ARTICLE VIII
DISCLAIMER OF LIABILITY AND/OR WARRANTY
---------------------------------------
8.1 NO WARRANTY. Nothing in this Agreement shall be construed as:
(a) a warranty or representation by Licensor as to the
validity or scope of any Licensed Proprietary
Property; or
(b) a warranty or representation that anything sold,
used, produced or otherwise disposed of under any
license granted in this Agreement is or will be free
from infringement of patents, copyrights, and/or
trademarks of third parties; or
(c) an express or implied warranty of merchantability or
fitness for a particular purpose.
8.2 NO DAMAGES. Licensor shall exercise reasonable care in verifying
the accuracy of information provided under this Agreement but, subject to the
provisions of the last sentence of Section 8.4, Licensor shall not be liable for
any damages arising out of or resulting from any information made available
hereunder or of the use thereof, nor shall it be liable to Licensee for
consequential damages under any circumstances.
8.3 NO WARRANTY OF QUALITY OR USEFULNESS. Licensor shall have no
responsibility for the ability of Licensee to use such information, the quality
or performance of any process or any product produced by Licensee with the aid
of such information, or with respect to claims of third parties arising from
Licensee's use of such information.
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8.4 INDEMNIFICATION. Licensee shall assume all responsibility and
liability for the sale, use, production, and/or commercialization of the
Products, including, but not limited to, the safety, effectiveness, and
reliability of the process and/or products produced pursuant to this Agreement.
Licensee further agrees to defend, indemnify, and hold Licensor, its trustees,
directors, officers, employees, agents, representatives, successors, assigns,
affiliated entities and controlled corporations (as defined herein) harmless
from and against any and all liability, demands, damages, expenses and losses
for death, personal injury, illness, or property damage, including the cost of
defense against same, which may be asserted, or any claims which may be brought
by third parties resulting from the sale, use, production, commercialization, or
other disposition of the Licensed Proprietary Property or Products by Licensee.
Licensee agrees that any sublicenses granted hereunder will include a similar
indemnification provision for the benefit of Licensor. Licensee acknowledges
that the Licensed Proprietary Property included herein is experimental and
agrees to take all reasonable precautions to prevent death, personal injury,
illness, and property damage. Licensor shall defend, indemnify, and hold
Licensee and its directors, officers, employees and agents harmless as against
any and all judgements, fees, expenses, liabilities, or other costs arising from
or incidental to any product liability or other lawsuit, claim, demand or other
action resulting from any claim, suit or proceeding brought by a third party
against any of the foregoing entities, arising out of or in connection with any
misrepresentation by Licensor with regard to, or in breach of, the
representations and warranties set forth in Article X or to the extent due to
the gross negligence or willful misconduct of Licensor.
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8.5 INSURANCE. Licensee agrees to purchase and/or maintain insurance
coverage sufficient, taking into account its other assets, to establish the
ability of Licensee to honor the indemnity made herein, and Licensor shall be
listed as an additional named insured on any such insurance coverage. Licensee
shall furnish evidence of its insurance coverage upon request of Licensor. For
purposes of this agreement, the initial amount of insurance coverage required is
in the face amount of Two Million Dollars ($2,000,000.00).
ARTICLE IX
TERM AND TERMINATION
--------------------
9.1 TERM. The Term of this Agreement shall be for a period of ten
(10) years extending from the first commercial revenue actually collected or for
the life of the last to expire of the patents or patent applications of the
Licensed Proprietary Property, whichever is earlier, unless sooner terminated as
herein provided.
9.2 TERMINATION FOR CAUSE; INSOLVENCY. If Licensee shall determine
that it intends to declare itself insolvent or file for bankruptcy or
reorganization, it shall give immediate written notice to Licensor. Failure to
give such notice shall cause immediate termination of this Agreement, and all
rights of Licensee in the Licensed Proprietary Property shall automatically
revert to Licensor. If Licensee shall become bankrupt or insolvent; if the
business or any assets or property of Licensee shall be placed in the hands of a
receiver, assignee or trustee, whether by the voluntary act of Licensee or
otherwise; if Licensee institutes or suffers to be instituted any procedure in
bankruptcy court for reorganization or rearrangement of its financial affairs;
or if Licensee makes a general
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assignment for the benefit of creditors, this Agreement shall immediately
terminate, and all rights of Licensee in the Licensed Proprietary Property shall
automatically revert to Licensor. Upon occurrence of any of the foregoing
events, Licensee shall give immediate written notice thereof to Licensor.
9.3 DEFAULT. Upon any breach or default under this Agreement by
Licensee, or upon any breach or default by Licensee under other legal agreements
between Licensor and Licensee, Licensor may give written notice thereof to
Licensee, and Licensee shall have thirty (30) days thereafter to cure such
breach or default. If such breach or default is not so cured, Licensor may then
in its sole discretion and option: (a) convert this exclusive License Agreement
into a non-exclusive License Agreement, or (b) terminate this Agreement and the
licenses granted by it, or (c) seek such other relief as may be provided by law
in such circumstances by giving written notice thereof to Licensee.
Notwithstanding the foregoing, in the event of any termination of this
Agreement, any sublicenses granted by Licensee shall remain in force and effect
and shall be assigned by Licensee to Licensor; provided that such sublicensee is
currently in good standing with regard to its obligations under the sublicense
or has cured any default or breach within the period provided in such
sublicense; and further provided that (a) the financial obligations of each such
sublicensee shall be limited to those due Licensor hereunder for the practice of
such a sublicense; and (b) Licensor shall have no greater obligations,
liabilities or duties to the sublicensee than Licensor has to Licensee under the
terms of this Agreement.
9.4 TERMINATION UPON NOTICE. Any provision herein not withstanding,
Licensee may terminate this Agreement, in its entirety or as to any particular
patent or patent
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application or item of Know-How within the Licensed Proprietary Property, at any
time by giving Licensor at least thirty (30) days prior written notice. From and
after the effective date of such termination under this Section 9.4 with respect
to a particular patent or patent application, such patent(s) or patent
application(s) in the particular country shall cease to be within the Licensed
Proprietary Property for all purposes of this Agreement. Likewise, from and
after the effective date of such termination under this Section 9.4 with respect
to a particular item of Know-How, such item of Know-How shall cease to be within
the Licensed Proprietary Property for all purposes of this Agreement. From and
after the effective date of termination of a patent, patent application or item
of Know-How under this Section 9.4, all rights and obligations of Licensee with
respect to such patent, patent application or item of Know-How shall terminate
with respect to a particular Product, and the license to the terminated patent,
patent application or item of Know-How granted to Licensee under Section 2.1
shall terminate with respect to such Product. Upon termination of this Agreement
in its entirety under this Section 9.4, all rights and obligations of the
parties shall terminate except as provided in Section 9.6 below.
9.5 DISCONTINUANCE OF COMMERCIALIZATION. Upon termination hereof for
any reason, Licensee agrees to discontinue the commercialization of the Licensed
Proprietary Property, and (except as expressly provided herein) all sublicenses
granted hereunder by Licensee shall terminate, or at the option of Licensor, be
deemed to have been assigned to Licensor.
9.6 PROVISIONS SURVIVING TERMINATION. Article V, Article XIII and
Sections 8.1, 8.2, 8.3, 8.4, 10.4 and 11.3 of this Agreement, as well as all
provisions relating to
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Guaranteed Value, shall survive termination of this Agreement.
ARTICLE X
REPRESENTATIONS AND WARRANTIES
------------------------------
10.1 WARRANTY TO TITLE. Licensor represents and warrants that (i) it
is a Nevada nonprofit corporation exempt from taxation under Section 501(c)(3)
of the Internal Revenue Code of 1986; (ii) it owns the Licensed Proprietary
Property; (iii) it has the legal power and authority to extend the rights
granted to Licensee pursuant to this Agreement; (iv) the execution, delivery and
performance of this Agreement have been duly authorized by all necessary
corporate action on the part of Licensor; (v) the Licensed Proprietary Property
is free and clear of any lien, encumbrance, security interest or restriction on
license in the Field of Use; (vi) it has not previously granted, and will not
grant during the term of this Agreement, any right, license or interest in or to
the Licensed Proprietary Property, or any portion thereof, in the Field of Use
inconsistent with the license granted to Licensee herein; and (vii) to
Licensor's best knowledge, there are no threatened or pending actions, suits,
investigations, claims or proceedings in any way relating to the Licensed
Proprietary Property.
10.2 NO OTHER INFORMATION. Licensor represents that it has no
knowledge of any information likely to have a material effect on the validity or
enforceability of any patents within Patent Rights or any claim thereof which
was not disclosed to the Patent Office at the time that the patent applications
therefor were filed or during the pendency of said applications.
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10.3 POWER AND AUTHORITY. Licensee represents and warrants that it has
full power and authority to enter into this Agreement and to carry out the
transactions contemplated hereby.
10.4 COMPLIANCE WITH LAWS. Licensee represents and warrants that it
will comply with all applicable laws and regulations, including without
limitation, all United States laws and regulations controlling the export of
commodities and technical data. Licensee will be solely responsible for any
violation of such laws or regulations by Licensee or its sublicensee, and it
will defend and hold Licensor harmless in the event of any legal action of any
nature occasioned by such violation.
ARTICLE XI
AGENCY/PARTNERSHIP/USE OF NAME
11.1 NO AGENCY. Neither party shall be deemed to be an agent of the
other party as a result of any transaction under or related to this Agreement,
and shall not in any way pledge the other party's credit or incur any
obligations on behalf of the other party.
11.2 NO PARTNERSHIP. This Agreement shall not constitute either a
partnership or a joint venture, and neither party may be bound by the other to
any contract, arrangement or understanding except as specifically stated herein.
11.3 PROHIBITION AGAINST USE OF NAME. Except to the extent required to
comply with applicable laws and regulations and subject to Section 13.3, without
prior written consent obtained from Licensor, which shall not be unreasonably
withheld, Licensee (including any Affiliate or sublicensee of Licensee) shall
not use for purposes of sales,
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advertising, marketing, marking of goods, promotion to investors, press releases
or other publicity, etc.: (i) the name of (or any other information which would
identify) Licensor or any corporation which is controlled by the same persons
who control Licensor ("Other Corporation"); (ii) the names of trustees,
directors, officers, or employees of Licensor or an Other Corporation; or (iii)
any trademarks (or adaptations thereof) of Licensor or an Other Corporation.
Without prior written consent obtained from Licensee, which shall not be
unreasonably withheld, Licensor (including Other Corporations and any other
Affiliate of Licensor) shall not use for purposes of sales, advertising,
marketing, marking of goods, promotion to investors, press releases or other
publicity: (i) the name of (or any other information which would identify)
Licensee or any corporation which is controlled by the same persons who control
Licensee ("Controlled Corporation"); (ii) the names of trustees, directors,
officers, or employees of Licensee or a Controlled Corporation; or (iii) any
trademarks (or adaptations thereof) of Licensee or a Controlled Corporation.
ARTICLE XII
MARKING
Licensee agrees to apply or have applied to all articles and to all
containers containing Products manufactured by it or any sublicensee(s) under
this Agreement such patent notices as may be required by the laws of the
territories where manufactured or as may reasonably be requested by Licensor.
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ARTICLE XIII
NONDISCLOSURE OF CONFIDENTIAL INFORMATION
13.1 CONFIDENTIAL INFORMATION. All Proprietary Property and
confidential scientific and technical information communicated by one party to
the other party under this Agreement, including information contained in patent
applications, if identified in writing as Confidential Information at the time
of disclosure, shall be kept confidential by such other party. Notwithstanding
the foregoing, either party shall be relieved of the confidentiality obligations
herein and not be prevented by this Agreement from utilizing any information
received by it from the other party if:
(a) the information, at the time of disclosure, is in the
public domain or, after disclosure, becomes part of
the public domain through no fault of the receiving
party;
(b) the receiving party can show that the information was
in its possession at the time of disclosure and was
not acquired, directly or indirectly, from the
disclosing party;
(c) the information is lawfully obtained or received from
a third party, other than the disclosing party,
having the legal right to transmit same;
(d) the disclosure of such information is essential for
the commercial exploitation of the Proprietary
Property under this Agreement, provided that such
information is disclosed subject to a secrecy
agreement;
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(e) was independently developed by the receiving party
without reference to any information or materials
disclosed by the disclosing party; or
(f) was subsequently disclosed to the receiving party by
a person other than a party without breach of any
legal obligation to the disclosing party.
13.2 ADDITIONAL PERMITTED DISCLOSURES. In addition, either party may
disclose Confidential Information of the other (i) to their legal
representatives, employees and Affiliates, and legal representatives and
employees of Affiliates, consultants and sublicensees, to the extent such
disclosure is reasonably necessary to achieve the purposes of this Agreement,
and provided such representatives, employees, consultants and sublicensees have
agreed in writing to obligations of confidentiality with respect to such
information no less stringent than those set forth herein; (ii) in connection
with the filing and support of patent applications; (iii) as reasonably required
in the course of a contemplated public offering or private financing; (iv) to a
potential sublicensee or corporate partner that has agreed in writing to
confidentiality obligations no less stringent than set forth herein; or (v) if
disclosure is compelled to be disclosed by a court order or applicable law or
regulation, provided that the party compelled to make such disclosure (a)
requests confidential treatment of such information; (b) provides the other
party with sufficient advance notice of the compelled disclosure to provide
adequate time to seek a protective order; and (c) discloses only the minimum
necessary to comply with the requirement to disclose.
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13.3 NON-DISCLOSURE. The terms of this Agreement shall not be
disclosed by Licensee or Licensor to any third party or be published unless both
parties expressly agree otherwise in writing. Either party shall allow at least
three (3) business days notice of any proposed public disclosure for the other
party's review and comment or to provide written consent. The text of any press
release to be issued by Licensee and/or Licensor concerning this Agreement as
well as the precise date and timing of the press release shall be agreed between
the parties in writing in advance, such agreement not to be unreasonably
withheld or delayed. However, this restriction shall not apply to announcements
required by law or regulation, except that in such event the parties shall
coordinate to the extent possible with respect to the details of any such
announcement. This restriction shall not apply to disclosure of this Agreement
to certain private third parties such as the shareholders, investment bankers,
attorneys and other professional consultants of, and prospective investors in,
Licensee or Licensor. Once a particular disclosure has been approved, further
disclosures to similarly situated private third parties under this provision
that do not differ materially therefrom may be made without obtaining any
further consent of the other party.
ARTICLE XIV
MISCELLANEOUS
14.1 CAPTIONS. The captions herein are for convenience only and shall
not be deemed to limit or otherwise affect the construction hereof.
14.2 NOTICES. Any notice or other communication hereunder must be
given in
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writing and (a) delivered in person, (b) transmitted by telex, telefax or other
telecommunications mechanism, (c) mailed by certified or registered mail,
postage prepaid, receipt requested, or (d) sent by overnight delivery with
charges prepaid and receipt acknowledged, as follows:
If to Licensor, addressed to:
Research Development Foundation
x/x Xxxxxx XxxXxxxxx, Xxx.
000 Xxxxx Xxxxxxxx Xxxxxx
Xxxxxx Xxxx, Xxxxxx 00000
Attn: X. X. Xxxxxx, President
cc: Xxxxx X. Xxxxxx, Esq.
If to Licensee, addressed to:
SuperGen, Inc.
Xxx Xxxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xx. Xxxxxx Xxxxxxxxx, CEO and President
cc: Xx. Xxxx Xxxxx, Senior Director, Planning and Legal
Affairs
or to such other address or to such other person as the party shall have last
designated by such notice to the other party. Each such notice or other
communication shall be effective (i) if given by mail, three (3) days after such
communication is deposited in the mails with postage prepaid, addressed as
aforesaid, or (ii) if given by telecommunication or any other means, when
actually received at such address.
14.3 ASSIGNMENT. This Agreement, in whole or in part, shall not be
assignable by either party without prior written consent of the other party,
which consent shall not be unreasonably withheld (unless to a successor entity
to the assigning party by merger, acquisition or other non-bankruptcy
reorganization), and any attempted assignment
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without such consent shall be void.
14.4 NO WAIVER. The failure of either party to enforce at any time any
of the provisions of this Agreement, or any rights in respect thereto, or to
exercise any election herein provided, shall in no way be considered to be a
waiver of such provisions, rights, or elections, or in any way to affect the
validity of this Agreement. The exercise by either party of any of its rights
herein or any of its elections under the terms or covenants herein shall not
preclude either party from exercising the same or any other rights it may have
under this Agreement, irrespective of any previous action or proceeding taken by
either party hereunder.
14.5 CHOICE OF LAW AND JURISDICTION. This Agreement shall be governed
and construed in accordance with the laws of the State of Nevada, U.S.A.
applicable to contracts made in such State without regard to conflicts of law
doctrines, and the parties agree that jurisdiction and venue for any dispute
regarding this Agreement will be in such State.
14.6 SEVERABILITY. If any provision of this Agreement is judicially
determined to be void or unenforceable, such provision shall be construed to be
severable from the other provisions of this Agreement, which shall retain full
force and effect.
14.7 FURTHER ACTS. The parties hereto agree promptly to execute,
forward, or otherwise provide all documents and material necessary or desirable
to effectuate this Agreement.
14.8 ENTIRE AGREEMENT. Except for a pre-existing confidentiality
agreement, the terms and conditions herein contained together with the Research
Agreement constitute
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the entire agreement between the parties and shall supersede all previous
communications, either oral or written, between the parties hereto with respect
to the subject matter hereof. No agreement or understanding bearing on the same
shall be binding upon either party hereto unless it shall be in writing and
signed by the duly authorized officer or representative of each of the parties
and shall expressly refer to this Agreement.
14.9 SUCCESSORS AND ASSIGNS. This Agreement shall be binding on and
shall inure to the benefit of the parties hereto, and their respective
successors and assigns.
[Remainder of page intentionally left blank]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed in multiple originals by their duly authorized representatives.
RESEARCH DEVELOPMENT FOUNDATION
By: /s/ Xxxxxx XxxXxxxxx
------------------------------------
Print Name: Xxxxxx XxxXxxxxx
---------------------------------
Title: Vice President
--------------------------
SUPERGEN, INC.
By: /s/ Xxxxxx Xxxxxxxxx
------------------------------------
Print Name: Xxxxxx Xxxxxxxxx
--------------------------------
Title: President & Chief Executive Officer
--------------------------------------
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EXHIBIT 1
Proprietary Property
[ * ]
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EXHIBIT 1A
Field of Use
[ * ]
This Field of Use is subject to modification pursuant to Section 6 b.
of the Research Agreement.
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EXHIBIT 2
List of Countries
United States
PCT *
* PCT Countries: All countries will be designated in the initial PCT filing.
Within 30 months of the U.S. filing date, Licensor must select
the specific PCT countries in which to actually file, which
countries are currently expected to be as follows: Australia,
Austria, Belgium, Canada, China, France, Germany, Ireland,
Israel, Italy, Japan, Republic of Korea, New Zealand,
Netherlands, Russian Federation, South Africa, Spain, Sweden,
Switzerland, Taiwan, United Kingdom
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EXHIBIT 3
Milestone Payments
Licensee shall make the following milestone payments to Licensor with
respect to each Product subject to this Agreement:
(a) [ * ] upon the earlier of (i) approval, or (ii) the
date of effectiveness, of an "IND" filed with the FDA
for such Product;
(b) [ * ] upon completion of a "Phase I" human clinical
trial for such Product and the Final Report thereon;
(c) [ * ] upon completion of a "Phase II" human clinical
trial for such Product and the Final Report thereon;
(d) [ * ] upon completion of any other phase of human
clinical trials for such Product required by the FDA
and the Final Report thereon; and
(e) [ * ] upon approval by the FDA of an "NDA" for such
Product.
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