EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
CYTOCLONAL PHARMACEUTICALS, INC.
FOR
PEPTIDE ANTIESTROGEN FOR BREAST CANCER THERAPY
CASE NO. LA97-103
TABLE OF CONTENTS
Article No. Title Page
----------- ----- ----
Recitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1. DEFINITIONS.. . . . . . . . . . . . . . . . . . . . . . . . . 2
2. GRANT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3. LICENSE ISSUE FEE . . . . . . . . . . . . . . . . . . . . . . 6
4. ROYALTIES . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5. DUE DILIGENCE . . . . . . . . . . . . . . . . . . . . . . . . 10
6. PROGRESS AND ROYALTY REPORTS. . . . . . . . . . . . . . . . . 11
7. BOOKS AND RECORDS . . . . . . . . . . . . . . . . . . . . . . 13
8. LIFE OF THE AGREEMENT . . . . . . . . . . . . . . . . . . . . 13
9. TERMINATION BY THE REGENTS. . . . . . . . . . . . . . . . . . 14
10. TERMINATION BY THE LICENSEE . . . . . . . . . . . . . . . . . 15
11. DISPOSITION OF PATENT PRODUCTS ON HAND UPON TERMINATION . . . 15
12. USE OF NAMES AND TRADEMARKS . . . . . . . . . . . . . . . . . 15
13. LIMITED WARRANTY. . . . . . . . . . . . . . . . . . . . . . . 16
14. PATENT PROSECUTION AND MAINTENANCE. . . . . . . . . . . . . . 17
15. PATENT MAKING . . . . . . . . . . . . . . . . . . . . . . . . 20
16. PATENT INFRINGEMENT . . . . . . . . . . . . . . . . . . . . . 20
17. INDEMNIFICATION . . . . . . . . . . . . . . . . . . . . . . . 22
18. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
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19. ASSIGNABILITY . . . . . . . . . . . . . . . . . . . . . . . . 24
20. LATE PAYMENTS . . . . . . . . . . . . . . . . . . . . . . . . 24
21. WAIVER. . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
22. FAILURE TO PERFORM. . . . . . . . . . . . . . . . . . . . . . 25
23. GOVERNING LAWS. . . . . . . . . . . . . . . . . . . . . . . . 25
24. GOVERNMENT APPROVAL OR REGISTRATION . . . . . . . . . . . . . 25
25. EXPORT CONTROL LAWS . . . . . . . . . . . . . . . . . . . . . 25
26. FORCE MAIEURE . . . . . . . . . . . . . . . . . . . . . . . . 26
27. CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . 26
28. INFRINGEMENT UNDER DRUG PRICE COMPETITION ACT.. . . . . . . . 28
29. MISCELLANEOUS . . . . . . . . . . . . . . . . . . . . . . . . 29
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▇▇ ▇▇▇▇ ▇▇. ▇▇▇▇-▇▇▇
Print date: August 4, 1998
EXCLUSIVE LICENSE AGREEMENT
FOR
CYTOCLONAL PHARMACEUTICS, INC.
This license agreement ("Agreement") is effective this 6th day of
August, 1998, by and between The Regents of the University of California
("The Regents"), a California corporation, having its statewide
administrative offices at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, and Cytoclonal Pharmaceutics, Inc, ("Licensee"), a
corporation, having a principal place of business at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇.,
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇.
RECITALS
Whereas, certain inventions, characterized as "Peptide Antiestrogen for
Breast Cancer Therapy" ("Invention") were made at the University of
California, Los Angeles by ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and are claimed in Patent
Rights defined below;
Whereas, the Licensee entered into a Secrecy Agreement ("Secrecy
Agreement"), effective 3-31-98 that allowed the Licensee to evaluate its
interest in taking a license to the Invention;
Whereas, the Invention was made under funding provided by UC Breast
Cancer Research Program;
Whereas, ▇▇. ▇▇▇▇▇▇▇ is an employee of the University of California;
Whereas, the Licensee is a "small entity" as defined in 37 CFR Section
1.9 and a "small-business concern" defined in 15 U.S.C. Section 632;
Whereas, both parties recognize that royalties due under this Agreement
will be paid on pending patent applications and issued patents;
Whereas, the Licensee requested certain rights from The Regents to
commercialize the Invention; and
Whereas, The Regents responded to the request of the Licensee by
granting the following rights to the Licensee so that the products and other
benefits derived from the Invention can be enjoyed by the general public.
The parties agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have the meaning set
forth below:
1.1 "Patent Rights" means all U.S. patents and patent applications and
foreign patents and patent applications assigned to The Regents, and in the case
of foreign patents and patent applications those requested under Paragraph 14.4
herein, including any reissues, extensions, substitutions, continuations,
divisions, and continuations-in-part applications (only to the extent, however,
that claims in the continuations-in-part applications are supported in the
specification of the parent patent application) based on and including any
subject matter claimed in or covered by U.S. Patent Provisional Application
Serial Number [ ] entitled Peptide Antiestrogen Compositions and Methods
for Treating Breast Cancer, filed by The Regents as well as the PCT application
[ ] filed 4-17-98 based upon the U.S. provisional
and both of which are assigned to The Regents.
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1.2 "Patent Products" means:
i any kit, composition of matter, material, or product;
ii any kit, composition of matter, material, or product to be
used in a manner requiring the performance of the Patent
Method; or
iii any kit, composition of matter, material, or product
produced by the Patent Method;
to the extent that the manufacture, use, or sale of such kit, composition of
matter, material, or product, in a particular country, would be covered by or
infringe, but for the license granted to the Licensee pursuant to this
Agreement, an unexpired claim of a patent or pending claim of a patent
application were it issued as a claim in a patent under Patent Rights in that
country in which such patent has issued or application is pending. This
definition of Patent Products also includes a service either used by the
Licensee or provided by the Licensee to its customers when such service
requires the practice of the Patent Method.
1.3 "Patent Method" means any process or method covered by the claims
of a patent application or patent within Patent Rights or the use or practice
of which would constitute in a particular country, but for the license
granted to the Licensee pursuant to this Agreement, an infringement of an
unexpired claim of a patent or pending claim of a patent application were it
issued as a claim in a patent within Patent Rights in that country in which
the Patent Method is used or practiced.
1.4 "Net Sales" means the gross invoice prices from the sale of
Patent Products by the Licensee, an Affiliate, a Joint Venture, or a
sublicensee to independent third parties for cash or other forms of
consideration in accordance with generally accepted accounting principles
limited to the
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following deductions (if not already deducted from the gross invoice price
and at rates customary within the industry): (a) allowances (actually paid
and limited to rejections, returns, and prompt payment and volume discounts
granted to customers of Patent Products, whether in cash or Patent Products
in lieu of cash); (b) freight, transport packing, insurance charges
associated with transportation; and (c) taxes, tariff, or import/export
duties based on sales when included in gross sales, but not value-added taxes
or taxes assessed on income derived from such sales. Where the Licensee
distributes Patent Products for end use to itself, an Affiliate, a Joint
Venture, or a sublicensee, then such distribution will be considered a sale
at the price normally charged to independent third parties, and The Regents
will be entitled to collect a royalty on such sale in accordance with Article
4 (Royalties).
1.5 "Affiliate(s)" of the Licensee means any entity which, directly or
indirectly, controls the Licensee, is controlled by the Licensee, or is under
common control with the Licensee ("control" for these purposes being defined as
the actual, present capacity to elect a majority of the directors of such
affiliate, or if not, the power to direct at least forty percent (40%) of the
voting rights entitled to elect directors) provided, however, that in any
country where the local law will not permit foreign equity participation of a
majority, then an "Affiliate" will include any company in which the Licensee
owns or controls, directly or indirectly, the maximum percentage of such
outstanding stock or voting rights permitted by local law. Each reference to
the Licensee herein will be meant to include its Affiliates.
1.6 "Joint Venture" means any separate entity established pursuant to
an agreement between a third party and the Licensee to constitute a vehicle for
a joint venture, in which the
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separate entity manufactures, uses, purchases, sells, or acquires Patent
Products from the Licensee. Each reference to the Licensee herein will be
meant to include its Joint Venture(s).
2. GRANT.
2.1 Subject to the limitations set forth in this Agreement and
subject to the licenses granted to the U.S. Government as set forth in the
Recitals above, The Regents hereby grants to the Licensee exclusive licenses
under Patent Rights to make, use, sell, offer for sale, and import Patent
Products and to practice the Patent Method where Patent Rights exist.
2.2 The licenses granted hereunder will be subject to the overriding
obligations to the U.S. Government including those set forth in 35 U.S.C.
200-212 and applicable governmental implementing regulations.
2.3 The manufacture of Patent Products and the practice of the Patent
Method will be subject to applicable government importation laws and
regulations of a particular country on Patent Products made outside the
particular country in which such Patent Products are used or sold.
2.4 The Regents also grants to the Licensee the right to issue
sublicenses to third parties to make, use, sell, offer for sale, and import
Patent Products and to practice Patent Method where Patent Rights exist,
provided the Licensee retains current exclusive rights thereto under this
Agreement. To the extent applicable, such sublicenses will include all of
the rights of and obligations due to The Regents (and, if applicable, the
United States Government) that are contained in this Agreement including
payment to The Regents of [ ] of the issue fee provided for in Article
3 (License Issue Fee) and payment of royalties at the rates provided for in
Article 4 (Royalties).
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2.5 The Licensee will notify The Regents of each sublicense granted
hereunder and provide The Regents with a copy of each sublicense. The
Licensee will collect and pay all fees and royalties due The Regents as set
forth in Paragraphs 3.1 and 4.1 below (and guarantee all such payments due)
from the sublicensees. The Licensee will require the sublicensees to provide
it with progress and royalty reports in accordance with the provisions
herein, and the Licensee will collect and deliver to The Regents all such
reports due from the sublicensees.
2.6 Upon termination of this Agreement for any reason, The Regents,
at its sole discretion, will determine whether any or all sublicenses will be
canceled or assigned to The Regents.
2.7 Because this Agreement grants the exclusive right to use or sell
the Patent Products in the United States, the Licensee acknowledges that any
Patent Products embodying the Invention or produced through the use thereof
will be manufactured substantially in the United States.
2.8 Nothing in this Agreement will be deemed to limit the right of
The Regents to publish any and all technical data resulting from any research
performed by The Regents relating to the Invention and to make and use the
Invention, Patent Product(s), Patent Method(s), and associated technology
solely for educational and research purposes and for purposes not covered by
this Agreement.
3. LICENSE ISSUE FEE.
3.1 As partial consideration for all the rights and licenses granted
to the Licensee, the Licensee will pay to The Regents a license issue fee of
$20,000 within 30 days after the execution of this Agreement by both parties.
3.2 Upon issuance of a patent application under the Patent Rights,
the Licensee will also pay to The Regents $25,000. This fee is nonrefundable
and is not an advance against royalties.
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3.3 Licensee must pay to The Regents a license maintenance fee
according to the schedule below:
Year 1 [ ]
Year 2 [ ]
Year 3 [ ]
Year 4 [ ]
Year 5 [ ]
Year 6 [ ]
And thereafter
Payment of the license maintenance fee begins on the one-year anniversary
date of the effective date of this Agreement and continues annually on each
anniversary date of the effective date of this Agreement. The license
maintenance fee will not be due and payable on any anniversary date of the
effective date of this Agreement if on such date the Licensee is commercially
selling Patent Products and paying an earned royalty to The Regents on the
sales of such Patent Products.
3.4 The fees set forth in Paragraphs 3.1, 3.2 and 3.3 above are
non-refundable, non-creditable, and not an advance against royalties.
4. ROYALTIES.
4.1 As further consideration for all the rights and licenses granted
to the Licensee, the Licensee and its sublicensees will pay to The Regents an
earned royalty at the rate of [ ] percent [ ] based on the Net
Sales of Patent Products.
4.2 Paragraphs 1.1, 1.3, and 1.4 define Patent Rights, Patent
Products, and Patent Method so that royalties will be payable on Patent
Products and Patent Method covered by both pending
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patent applications and issued patents. Earned royalties will accrue in each
country for the duration of Patent Rights in that country and will be payable
to The Regents when Patent Products are invoiced, or if not invoiced, when
delivered to a third party or to itself, an Affiliate, Joint Venture, or the
sublicensee in the case where such delivery of the Patent Products to the
Licensee, an Affiliate, Joint Venture, or the sublicensee is intended for end
use or FOR PURPOSES OTHER THAN CLINICAL TRIALS.
4.3 Royalties accruing to The Regents will be paid to The Regents
quarterly on or before the following dates of each calendar year:
- February 28 for the calendar quarter ending December 31;
- May 31 for the calendar quarter ending March 31;
- August 31 for the calendar quarter ending June 30; and
- November 30 for the calendar quarter ending September 30.
4.4 Each such payment will be for royalties which accrued up to the
most recently completed calendar quarter of the Licensee.
4.5 If Licensee is required to pay a non-Affiliate third party
royalties with respect to a Licensed Product under agreements for patent
rights which Licensee in its reasonable judgement determines are necessary to
license or acquire with respect to such Licensed Product, Licensee may deduct
[ ] % from the Regents' royalty rate pursuant to Paragraph 4.1 for every
[ ] in royalty paid to such non-Affiliate third parties. In no event
will the royalties due to The Regents pursuant to Paragraph 4.1 above be
reduced to less than [ ] of the amount that would be otherwise due to
The Regents thereunder.
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Beginning in the first year of commercial sales, the Licensee will pay
to The Regents a minimum annual royalty of [ ]. This minimum
annual royalty will be paid to The Regents by February 28 of each year and
will be credited against the earned royalty due and owing for the calendar
year in which the minimum payment was made.
4.6 Milestone payments will be made on each Licensed Product as
indicated below. Licensee will pay to The Regents the following payments
within 30 days of reaching the milestones:
Filing of IND [ ]
Filing of NDA [ ]
FDA Approval [ ]
4.7 All monies due The Regents will be payable in United States funds
collectible at par in San Francisco, California. When Patent Products are
sold for monies other than United States dollars, the earned royalties will
first be determined in the foreign currency of the country in which such
Patent Products were sold and then converted into equivalent United States
funds. The exchange rate will be that rate quoted in the Wall Street Journal
on the last business day of the reporting period.
4.8 Earned royalties on sales of Patent Products occurring in any
country outside the United States will not be reduced by any taxes, fees, or
other charges imposed by the government of such country except those taxes,
fees, and charges allowed under the provisions of Paragraph 1.4 (Net Sales).
The Licensee will also be responsible for all bank transfer charges.
4.9 Notwithstanding the provisions of Article 26 (Force Majeure), if
at any time legal restrictions prevent prompt remittance of part or all
royalties owed to The Regents by the Licensee
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with respect to any country where a Patent Product is sold or distributed,
the Licensee will convert the amount owed to The Regents into United States
funds and will pay The Regents directly from another source of funds for the
amount impounded.
4.10 In the event that any patent or any claim thereof included within
the Patent Rights is held invalid in a final decision by a court of competent
jurisdiction and last resort and from which no appeal has or can be taken,
all obligation to pay royalties based on such patent or claim or any claim
patentably indistinct therefrom will cease as of the date of such final
decision. The Licensee will not, however, be relieved from paying any
royalties that accrued before such decision or that are based on another
patent or claim that has not expired or that is not involved in such decision.
4.11 No royalties will be collected or paid hereunder to The Regents
on Patent Products sold to the account of the U.S. Government. The Licensee
and its sublicensee will reduce the amount charged for Patent Products
distributed to the United States Government by an amount equal to the royalty
for such Patent Products otherwise due The Regents as provided herein.
5. DUE DILIGENCE.
5.1 Upon the execution of this Agreement, Licensee must diligently
proceed with the development, manufacture and sale ("Commercialization") of
Licensed Products and must earnestly and diligently endeavor to market them
within a reasonable time after execution of this Agreement and in quantities
sufficient to meet the market demands for them.
5.2 Licensee must endeavor to obtain all necessary governmental
approvals for the Commercialization of Licensed Products.
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5.3 The Regents has the right and option to terminate this Agreement
if Licensee fails to perform any of the terms in this Paragraph 5.3. This
right, if exercised by The Regents, supersedes the rights granted in Article
2 (Grant).
I Identify a lead compound by [ ]
II Complete toxicity studies by [ ]
III File IND by [ ]
IV Complete Phase I clinical trials by [ ]
V Complete Phase 11 clinical trials by [ ]
VI Complete Phase III clinical trials by [ ]
VII Submit Product License Application by [ ]
5.4 To exercise its right under Paragraph 5.3 to terminate this
Agreement, The Regents must give Licensee written notice of the deficiency.
Licensee thereafter has 60 days to cure the deficiency or request
arbitration. If The Regents does not receive within 60 days either a written
request for arbitration or satisfactory tangible evidence that Licensee has
cured the deficiency, then The Regents may, at its option, terminate this
Agreement by giving written notice to Licensee.
5.5 Licensee has the sole discretion for making all decisions as to
how to commercialize any Licensed Product.
6. PROGRESS AND ROYALTY REPORTS.
6.1 Beginning August 15, 1999 and semi-annually thereafter, the
Licensee will submit to The Regents a progress report covering activities by
the Licensee related to the development and testing of all Patent Products
and the obtaining of the governmental approvals necessary for marketing them.
These progress reports will be provided to The Regents to cover the progress
of
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the research and development of the Patent Products until their first
commercial sale in the United States.
6.2 The progress reports submitted under Paragraph 6.1 will include,
but not be limited to, the following topics so that The Regents may be able
to determine the progress of the development of Patent Products and may also
be able to determine whether or not the Licensee has met its diligence
obligations set forth in Article 5 (Due Diligence) above:
- summary of work completed
- key scientific discoveries
- summary of work in progress
- current schedule of anticipated events or milestones
- market introduction date of Patent Products,
- a summary of resources (dollar value) spent in the reporting
period, and
- activities of the sublicensees, if any.
6.3 The Licensee will also report to The Regents in its immediately
subsequent progress and royalty report the date of first commercial sale of a
Patent Product(s) in each country.
6.4 After the first commercial sale of a Patent Product, the Licensee
will provide The Regents with quarterly royalty reports to The Regents on or
before each February 28, May 31, August 3 1, and November 30 of each year.
Each such royalty report will cover the most recently completed calendar
quarter of the Licensee (October through December, January through March,
April through June, and July through September) and will show:
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6.4a the gross sales and Net Sales of Patent Products sold by
the Licensee and reported to the Licensee as sold by its sublicensees during
the most recently completed calendar quarter;
6.4b the number of Patent Products sold or distributed by the
Licensee and reported to the Licensee as sold or distributed by its
sublicensees;
6.4c the royalties, in U.S. dollars, payable hereunder with
respect to Net Sales; and
6.4d the exchange rates used, if any.
6.5 If no sales of Patent Products have been made during any reporting
period after the first commercial sale of a Patent Product, then a statement to
this effect is required.
7. BOOKS AND RECORDS.
7.1 The Licensee will keep books and records accurately showing all
Patent Products manufactured, used, and/or sold under the terms of this
Agreement. Such books and records will be preserved for at least five years
after the date of the royalty payment to which they pertain and will be open
to inspection by representatives or agents of The Regents at reasonable times
to determine the accuracy of the books and records and to determine
compliance by the Licensee with the terms of this Agreement.
7.2 The fees and expenses of representatives of The Regents
performing such an examination will be borne by The Regents. However, if an
error in royalties of more than five percent (5%) of the total royalties due
for any year is discovered, then the fees and expenses of these
representatives will be borne by the Licensee.
8. LIFE OF THE AGREEMENT.
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8.1 Unless otherwise terminated by operation of law or by acts of the
parties in accordance with the terms of this Agreement, this Agreement will
be in force from the effective date recited on page one and will remain in
effect for the life of the last-to-expire patent licensed under this
Agreement, or until the last patent application licensed under this Agreement
is abandoned.
8.2 Any termination of this Agreement will not affect the rights and
obligations set forth in the following Articles:
Article 7 Books and Records
Article 11 Disposition of Patent Products on Hand Upon
Termination
Article 12 Use of Names and Trademarks
Paragraph 14.6 Patent Prosecution and Maintenance
Article 17 Indemnification
Article 22 Failure to Perform
Article 27 Confidentiality
8.3 Any termination of this Agreement shall not relieve the Licensee
of its obligation to pay any monies due or owing at the time of such
termination and shall not relieve any obligations, of either party to the
other party, established prior to termination.
9. TERMINATION BY THE REGENTS.
9.1 If the Licensee should violate or fail to perform any term or
covenant of this Agreement, then The Regents may give written notice of such
default ("Notice of Default") to the Licensee. If the Licensee should fail
to repair such default within 60 days after the date of such notice takes
effect, The Regents will have the right to terminate this Agreement and the
licenses herein by a second written notice ("Notice of Termination") to the
Licensee. If a Notice of Termination is sent to the Licensee, this Agreement
will automatically terminate on the date such notice takes effect. Such
termination will not relieve the Licensee of its obligation to pay any
royalty
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or license fees owing at the time of such termination and will not impair any
accrued right of The Regents. These notices will be subject to Article 18
(Notices).
10. TERMINATION BY THE LICENSEE.
10.1 The Licensee will have the right at any time to terminate this
Agreement in whole or as to any portion of Patent Rights by giving notice in
writing to The Regents. Such Notice of Termination will be subject to
Article 18 (Notices) and termination of this Agreement will be effective 60
days after the effective date thereof.
10.2 Any termination pursuant to the above paragraph will not relieve
the Licensee of any obligation or liability accrued hereunder prior to such
termination or rescind anything done by the Licensee or any payments made to
The Regents hereunder prior to the time such termination becomes effective,
and such termination will not affect in any manner any rights of The Regents
arising under this Agreement prior to such termination. Such termination
will not relieve the Licensee of its obligation to pay any fees or royalties
owing at the time of such termination and will not impair any accrued right
of The Regents.
11. DISPOSITION OF PATENT PRODUCTS ON HAND UPON TERMINATION.
11.1 Upon termination of this Agreement, the Licensee will have the
privilege of selling of all previously made or partially made Patent
Products, but no more, within a period of 120 days, provided, however, that
the sale of such Patent Products will be subject to the terms of this
Agreement including, but not limited to the payment of royalties based on the
Net Sales of Patent Products at the rates and at the times provided herein
and the rendering of reports in connection therewith.
12. USE OF NAMES AND TRADEMARKS.
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12.1 Nothing contained in this Agreement will be construed as
conferring any right to use in advertising, publicity, or other promotional
activities any name, trade name, trademark, or other designation of either
party hereto by the other (including contraction, abbreviation or simulation
of any of the foregoing). Unless required by law or consented to in writing
by the Executive Director, Office of Technology Transfer of The Regents, the
use by the Licensee of the name "The Regents of the University of California"
or the name of any campus of the University of California for use in
advertising, publicity, or other promotional activities is expressly
prohibited.
12.2 It is understood that The Regents will be free to release to the
inventors and senior administrative officials employed by The Regents the
terms of this Agreement upon their request. If such release is made, The
Regents will request that such terms will be kept in confidence in accordance
with the provisions of Article 27 (Confidentiality) and not be disclosed to
others. It is further understood that should a third party inquire whether a
license to Patent Rights is available, The Regents may disclose the existence
of this Agreement and the extent of the grant in Article 2 (Grant) to such
third party, but will not disclose the name of the Licensee, except where The
Regents is required to release such information under either the California
Public Records Act or other applicable law.
13. LIMITED WARRANTY.
13.1 The Regents warrants to the Licensee that it has the lawful right
to grant this license.
13.2 This license and the associated Invention, Patent Rights, Patent
Products, and Patent Methods are provided WITHOUT WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR
IMPLIED. THE REGENTS MAKES NO REPRESENTATION OR WARRANTY THAT THE INVENTION,
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PATENT RIGHTS, PATENT PRODUCTS, OR PATENT METHOD WILL NOT INFRINGE ANY PATENT
OR OTHER PROPRIETARY RIGHT.
13.3 IN NO EVENT WILL THE REGENTS BE LIABLE FOR ANY INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR
THE USE OF THE INVENTION, PATENT RIGHTS, PATENT METHOD, OR PATENT PRODUCTS.
13.4 Nothing in this Agreement will be construed as:
13.4a a warranty or representation by The Regents as to the
validity, enforceability, or scope of any Patent Rights; or
13.4b a warranty or representation 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 of third parties; or
13.4c an obligation to bring or prosecute actions or suits
against third parties for patent infringement except as provided in
Article 16. (Patent Infringement); or
13.4d conferring by implication, estoppel, or otherwise any
license or rights under any patents of The Regents other than Patent Rights
as defined herein, regardless of whether such patents are dominant or
subordinate to Patent Rights; or
13.4e an obligation to furnish any know-how not provided in
Patent Rights or Patent Products.
14. PATENT PROSECUTION AND MAINTENANCE.
14.1 The Regents will diligently prosecute and maintain the United
States and foreign patents comprising Patent Rights using counsel of its
choice. The Regents will promptly provide
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the Licensee with copies of all relevant documentation so that the Licensee
may be currently and promptly informed and apprised of the continuing
prosecution, and may comment upon such documentation sufficiently in advance
of any initial deadline for filing a response, provided, however, that if the
Licensee has not commented upon such documentation prior to the initial
deadline for filing a response with the relevant government patent office or
The Regents must act to preserve Patent Rights, The Regents will be free to
respond appropriately without consideration of comments by the Licensee, if
any. Both parties hereto will keep this documentation in confidence in
accordance with the provisions of Article 27 (Confidentiality) herein.
Counsel for The Regents will take instructions only from The Regents.
14.2 The Regents will use all reasonable efforts to amend any patent
application to include claims requested by the Licensee and required to
protect the Patent Products contemplated to be sold or Patent Method to be
practiced under this Agreement.
14.3 The Regents and the Licensee will cooperate in applying for an
extension of the term of any patent included within Patent Rights, if
appropriate, under the Drug Price Competition and Patent Term Restoration Act
of 1984. The Licensee will prepare all such documents, and The Regents will
execute such documents and will take such additional action as the Licensee
may reasonably request in connection therewith.
14.4 The Regents will, at the request of the Licensee, file,
prosecute, and maintain patent applications and patents covered by Patent
Rights in foreign countries if available. The Licensee must notify The
Regents within seven months of the filing of the corresponding United States
application of its decision to request The Regents to file foreign
counterpart patent applications. This notice concerning foreign filing must
be in writing and must identify the countries desired. The
18
absence of such a notice from the Licensee to The Regents within the seven
month period will be considered an election by the Licensee not to request
The Regents to secure foreign patent rights on behalf of the Licensee. The
Regents will have the right to file patent applications at its own expense in
any country the Licensee has not included in its list of desired countries,
and such applications and resultant patents, if any, will not be included in
the licenses granted under this Agreement.
14.5 All past, present and future costs of preparing, filing,
prosecuting and maintaining all United States and foreign patent applications
and all costs and fees relating to the preparation and filing of patents
covered by Patent Rights in Paragraph 1.1 will be borne by the Licensee.
This includes patent preparation and prosecution costs for this Invention
incurred by The Regents prior to the execution of this Agreement. Such costs
will be due upon execution of this Agreement and will be payable at the time
that the license issue fee is payable. The costs of all interferences and
oppositions will be considered prosecution expenses and also will be borne by
the Licensee. The Licensee will reimburse The Regents for all costs and
charges within 30 days following receipt of an itemized invoice from The
Regents for same.
14.6 The obligation of the Licensee to underwrite and to pay patent
preparation, filing, prosecution, maintenance, and related costs will
continue for costs incurred until three months after receipt by either party
of a Notice of Termination. The Licensee will reimburse The Regents for all
patent costs incurred during the term of the Agreement and for three months
thereafter whether or not invoices for such costs are received during the
three-month period after receipt of a Notice of Termination. The Licensee
may with respect to any particular patent application or patent terminate its
obligations to the patent application or patent in any or all designated
countries upon three months written notice to The Regents. The Regents may
continue prosecution and/or maintenance of such
19
application(s) or patent(s) at its sole discretion and expense, provided,
however, that the Licensee will have no further right or licenses thereunder.
14.7 The Licensee will notify The Regents of any change of its status
as a small entity (as defined by the United States Patent and Trademark
Office) and of the first sublicense granted to an entity that does not
qualify as a small entity as defined therein.
15. PATENT MAKING.
15.1 The Licensee will ▇▇▇▇ all Patent Products made, used, or sold
under the terms of this Agreement, or their containers, in accordance with
the applicable patent marking laws.
16. PATENT INFRINGEMENT.
16.1 In the event that the Licensee learns of the substantial
infringement of any patent licensed under this Agreement, the Licensee will
call the attention of The Regents thereto in writing and will provide The
Regents with reasonable evidence of such infringement. Both parties to this
Agreement acknowledge that during the period and in a jurisdiction where the
Licensee has exclusive rights under this Agreement, neither will notify a
third party of the infringement of any of Patent Rights without first
obtaining consent of the other party, which consent will not be unreasonably
withheld. Both parties will use their best efforts in cooperation with each
other to terminate such infringement without litigation.
16.2 If the Licensee desires that Patent Rights be enforced against
infringers, the Licensee either may request permission from The Regents to
file suit against the infringement of Patent Rights or may request that The
Regents take legal action against the infringement of Patent Rights. Such
request must be made in writing and must include reasonable evidence of such
infringement and
20
damages to the Licensee. If the infringing activity has not been abated
within 90 days following the effective date of such request, The Regents will
have the right to elect to:
16.2a commence suit on its own account; or
16.2b refuse to participate in such suit and The Regents will
give notice of its election in writing to the Licensee by the end of the
100th day after receiving notice of such request from Licensee. The Licensee
may thereafter bring suit for patent infringement if and only if The Regents
elects not to commence suit and if the infringement occurred during the
period and in a jurisdiction where the Licensee had exclusive rights under
this Agreement. However, in the event the Licensee elects to bring suit in
accordance with this Paragraph, The Regents may thereafter join such suit at
its own expense.
16.3 Such legal action as is decided upon will be at the expense of
the party on account of whom suit is brought and all recoveries recovered
thereby will belong to such party, provided, however, that legal action
brought jointly by The Regents and the Licensee and participated in by both
will be at the joint expense of the parties and all recoveries will be
allocated in the following order: a) to each party reimbursement in equal
amounts of the attorney's costs, fees, and other related expenses to the
extent each party paid for such costs, fees, and expenses until all such
costs, fees, and expenses are consumed for each party; and b) any remaining
amount shared jointly by them in proportion to the share of expenses paid by
each party.
16.4 Each party will cooperate with the other in litigation
proceedings instituted hereunder but at the expense of the party on account
of whom suit is brought. Such litigation will be controlled by the party
bringing the suit, except that The Regents may be represented by counsel of
its choice in any suit brought by the Licensee.
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17. INDEMNIFICATION.
17.1 The Licensee will (and require its sublicensees to) indemnify,
hold harmless, and defend The Regents, its officers, employees, and agents;
the sponsors of the research that led to the Invention; the inventors of any
invention covered by patents or patent applications in Patent Rights
(including the Patent Products and Patent Method contemplated thereunder) and
their employers against any and all claims, suits, losses, damage, costs,
fees, and expenses resulting from or arising out of exercise of this license
or any sublicense. This indemnification will include, but will not be limited
to, any product liability.
17.2 The Licensee, at its sole cost and expense, will insure its
activities in connection with the work under this Agreement and obtain, keep
in force, and maintain insurance as follows: (or an equivalent program of
self insurance).
17.3 Comprehensive or Commercial Form General Liability Insurance
(contractual liability included) with limits as follows:
Each Occurrence . . . . . . . . . . . . . . . . . . $5,000,000
Products/Completed Operations Aggregate . . . . . . $5,000,000
Personal and Advertising Injury . . . . . . . . . . $5,000,000
General Aggregate (commercial form only) . . . . . $5,000,000
It should be expressly understood, however, that the coverages and limits
referred to under the above will not in any way limit the liability of the
Licensee. The Licensee will furnish The Regents with certificates of
insurance evidencing compliance with all requirements. Such certificates will:
17.3a Provide for 30 day advance written notice to The Regents
of any modification;
22
17.3b Indicate that The Regents has been endorsed as an
additional Insured under the coverages referred to under the above; and
17.3c Include a provision that the coverages will be primary
and will not participate with nor will be excess over any valid and
collectable insurance or program of self-insurance carried or maintained by
The Regents.
17.4 The Regents will promptly notify the Licensee in writing of any
claim or suit brought against The Regents in respect of which The Regents
intends to invoke the provisions of this Article 17 (Indemnification). The
Licensee will keep The Regents informed on a current basis of its defense of
any claims pursuant to this Article 17 (Indemnification).
18. NOTICES.
18.1 Any notice or payment required to be given to either party will
be deemed to have been properly given and to be effective:
18.1a on the date of delivery if delivered in person;
18.1b on the date of mailing if mailed by first-class certified
mail, postage paid; or
18.1c on the date of mailing if mailed by any global express
carrier service that requires the recipient to sign the documents
demonstrating the delivery of such notice of payment; to the respective
addresses given below, or to another address as designated in writing by the
party changing its prior address.
In the case of the Licensee: XXX
XXX
XXX, XXX XXX
Telephone: XXX
Facsimile: XXX
Attention: XXX
23
In the case of The Regents: THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
Business Research Partnerships
University of California, Los Angeles
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Telephone: ▇▇▇-▇▇▇-▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
19. ASSIGNABILITY.
19.1 This Agreement is binding upon and will inure to the benefit of
The Regents, its successors and assigns, but will be personal to the Licensee
and assignable by the Licensee only with the written consent of The Regents.
Any other attempt by Licensee to assign this Agreement is void unless
Licensee obtains the prior written consent of The Regents.
20. LATE PAYMENTS.
20.1 In the event royalty payments, fees, or patent prosecution costs
are not received by The Regents when due, the Licensee will pay to The
Regents interest charges at a rate of ten percent (10%) simple interest per
annum. Such interest will be calculated from the date payment was due until
actually received by The Regents. Acceptance by The Regents of any late
payment interest from the Licensee under this Paragraph 20 will in no way
affect the provision of Article 21 (Waiver) herein.
21. WAIVER.
21.1 It is agreed that no waiver by either party hereto of any breach
or default of any of the covenants or agreements herein set forth will be
deemed a waiver as to any subsequent and/or similar breach or default.
24
22. FAILURE TO PERFORM.
22.1 In the event of a failure of performance due under the terms of
this Agreement and if it becomes necessary for either party to undertake
legal action against the other on account thereof, then such legal action
will be conducted in San Francisco, California, and the prevailing party will
be entitled to reasonable attorney's fees in addition to costs and necessary
disbursements.
23. GOVERNING LAWS.
23.1 THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE
WITH THE LAWS OF THE STATE OF CALIFORNIA, excluding any choice of law rules
that would direct the application of the laws of another jurisdiction, but
the scope and validity of any patent or patent application will be governed
by the applicable laws of the country of such patent or patent application.
24. GOVERNMENT APPROVAL OR REGISTRATION.
24.1 If this Agreement or any associated transaction is required by
the law of any nation to be either approved or registered with any
governmental agency, the Licensee will assume all legal obligations to do so.
The Licensee will notify The Regents if it becomes aware that this Agreement
is subject to a United States or foreign government reporting or approval
requirement. The Licensee will make all necessary filings and pay all costs
including fees, penalties, and all other out-of-pocket costs associated with
such reporting or approval process.
25. EXPORT CONTROL LAWS.
25.1 The Licensee will observe all applicable United States and
foreign laws with respect to the transfer of Patent Products and related
technical data to foreign countries, including, without
25
limitation, the International Traffic in Arms Regulations (ITAR) and the
Export Administration Regulations.
26. FORCE MAIEURE.
26.1 The parties to this Agreement will be excused from any
performance required hereunder if such performance is rendered impossible or
unfeasible due to any acts of God, catastrophes, or other major events beyond
their reasonable control, including, without limitation, war, riot, and
insurrection; laws, proclamations, edicts, ordinances, or regulations;
strikes, lock-outs, or other serious labor disputes; and floods, fires,
explosions, or other natural disasters. However, any party to this Agreement
will have the right to terminate this Agreement upon 30 days' prior written
notice if either party is unable to fulfill its obligations under this
Agreement due to any of the causes mentioned above and such inability
continues for a period of one year. Notices will be subject to Article 18
(Notices).
27. CONFIDENTIALITY.
27.1 The Licensee and The Regents respectively will treat and maintain
the proprietary business, patent prosecution, software, engineering drawings,
process and technical information, and other proprietary information
("Proprietary Information") of the other party in confidence using at least
the same degree of care as that party uses to protect its own proprietary
information of a like nature for a period from the date of disclosure until
five years after the date of termination of this Agreement. This
confidentiality obligation will apply to the information defined as "Data"
under the Secrecy Agreement, and such Data will be treated as Proprietary
Information hereunder.
27.2 All Proprietary Information will be labeled or marked
confidential or as otherwise similarly appropriate by the disclosing party,
or if the Proprietary Information is orally disclosed,
26
it will be reduced to writing or some other physically tangible form, marked
and labeled as set forth above by the disclosing party, and delivered to the
receiving party within 30 days after the oral disclosure as a record of the
disclosure and the confidential nature thereof. Notwithstanding the
foregoing, the Licensee and The Regents may use and disclose Proprietary
Information to its employees, agents, consultants, contractors, and, in the
case of the Licensee, its sublicensees, provided that any such parties are
bound by a like duty of confidentiality.
27.3 Nothing contained herein will in any way restrict or impair the
right of the Licensee or The Regents to use, disclose, or otherwise deal with
any Proprietary Information:
27.3a that recipient can demonstrate by written records was
previously known to it;
27.3b that is now, or becomes in the future, public knowledge
other than through acts or omissions of recipient;
27.3c that is lawfully obtained without restrictions by
recipient from sources independent of the disclosing party;
27.3d that is required to be disclosed to a governmental entity
or agency in connection with seeking any governmental or regulatory approval,
or pursuant to the lawful requirement or request of a governmental entity or
agency;
27.3e that is furnished to a third party by the recipient with
similar confidentiality restrictions imposed on such third party, as
evidenced in writing; or
27.3f that The Regents is required to disclose pursuant to the
California Public Records Act or other applicable law.
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27.4 Upon termination of this Agreement, the Licensee and The Regents
will destroy or return to the disclosing party proprietary information
received from the other in its possession within 15 days following the
effective date of termination. The Licensee and The Regents will provide each
other, within 30 days following termination, with a written notice that
Proprietary Information has been returned or destroyed. Each party may,
however, retain one copy of Proprietary Information for archival purposes in
non-working files.
28. INFRINGEMENT UNDER DRUG PRICE COMPETITION ACT.
28.1 In the event either party receives notice pertaining to any
patent included within Patent Rights pursuant to the DRUG PRICE COMPETITION
AND PATENT TERM RESTORATION ACT OF 1984, (Public Law ▇▇-▇▇▇, "▇▇▇ ▇▇▇")
including but not necessarily limited to notices pursuant to Sections 101 and
103 of the Act from persons who have filed an abbreviated NDA ("ANDA") or a
"paper" NDA, or in the case of an infringement of Patent Rights as defined in
Section 271(e) of Title 35 of the United States Code, such party will notify
the other party promptly but in no event later than ten days after receipt of
such notice.
28.2 If the Licensee wishes action to be taken against such
infringement, as provided in the Act, the Licensee will request such action
by written notice to The Regents. Within 30 days after receiving such
request, The Regents will give written notice to the Licensee of its election
to:
28.2a commence suit on its own account; or
28.2b refuse to participate in such suit. The Licensee may
thereafter bring suit for patent infringement as provided by the Act if and
only if The Regents elects not to commence suit and if the infringement
occurred during the period that the Licensee had exclusive rights in the
▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ under this Agreement. However, in the event the Licensee
elects to bring suit in accordance with this paragraph, The Regents may
thereafter join such suit at its own expense.
28.3 The provisions of Paragraphs 16.3 and 16.4 will likewise apply to
any legal action brought under this Article 28.
28.4 The Regents hereby authorizes the Licensee to include in any NDA
for a Patent Product, a list of patents included within Patent Rights
identifying The Regents as patent owner.
29. MISCELLANEOUS.
29.1 The headings of the several sections are inserted for convenience
of reference only and are not intended to be a part of or to affect the
meaning or interpretation of this Agreement.
29.2 This Agreement will not be binding upon the parties until it has
been signed below on behalf of each party, in which event, it will be
effective as of the date recited on page one.
29.3 No amendment or modification hereof will be valid or binding upon
the parties unless made in writing and signed on behalf of each party.
29.4 This Agreement embodies the entire understanding of the parties
and will supersede all previous communications, representations or
understandings, either oral or written, between the parties relating to the
subject matter hereof. The Secrecy Agreement specified in the Recitals in
this Agreement and dated 3-31-98 is hereby terminated.
29.5 In case any of the provisions contained in this Agreement are
held to be invalid, illegal, or unenforceable in any respect, such
invalidity, illegality, or unenforceability will not affect any other
provisions hereof, but this Agreement will be construed as if such invalid or
illegal or unenforceable provisions had never been contained herein.
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29.6 This Agreement has been negotiated and prepared jointly by both
parties and shall not be construed for or against any party but shall be
given a fair and reasonable construction in accordance with the intention of
the parties.
In witness whereof, both The Regents and the Licensee have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, on the date and year hereinafter written.
THE REGENTS OF THE UNIVERSITY
CYTOCLONAL PHARMACEUTICS, INC. OF CALIFORNIA
By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇
----------------------------- -----------------------------
(Signature) 8/6/98 (Signature) 8/4/98
Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
-----------------------------
(Please Print) Title: Technology Transfer Officer
Title: Chairman &
Chief Executive Officer
-----------------------------
30
