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EXHIBIT
10.2
EXCLUSIVE LICENSE
AGREEMENT
Table of Contents
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Article
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Page |
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I.
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DEFINITIONS |
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1 |
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II.
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GRANT OF
RIGHTS |
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4 |
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III.
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ROYALTIES
AND PAYMENTS |
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7 |
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IV.
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REPORTING, PAYMENT AND MARKING |
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10 |
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V.
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ADDITIONAL PATENT APPLICATIONS AND RIGHT TO FILE
SUIT |
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12 |
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VI.
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DURATION
AND TERMINATION |
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14 |
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VII.
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ADDRESSES |
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16 |
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VIII.
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CONFIDENTIAL INFORMATION |
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17 |
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IX.
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ENTIRE
AGREEMENT |
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19 |
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X.
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ASSIGNMENT |
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19 |
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XI.
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REPRESENTATIONS AND WARRANTIES |
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19 |
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XII.
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INDEMNIFICATION |
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20 |
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XIII.
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PUBLICITY
AND NEWS RELEASES |
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21 |
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XIV.
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MISCELLANEOUS |
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EXCLUSIVE LICENSE
AGREEMENT
This Exclusive License
Agreement (“Agreement”) is entered into by and between
THE BOARD OF REGENTS of THE UNIVERSITY OF TEXAS SYSTEM (hereinafter
“BOARD”), a governing board established under the laws
of the State of Texas, THE UNIVERSITY OF TEXAS SYSTEM CANCER CENTER
(hereinafter “UTSCC”), a component institution of The
University of Texas System (hereinafter “System”) and
ARGUS PHARMACEUTICALS, INC. (hereinafter “LICENSEE”), a
Delaware corporation, whose address is 2170 Buckthorne Place, Suite
350-A, The Woodlands, Texas 77380 and shall be effective as of the
effective date as provided for hereinafter.
WITNESSETH
:
WHEREAS, BOARD is the owner
of the BOARD Patent Rights and BOARD Technical Information, as
hereinafter defined, conceived, discovered, or reduced to practice
by UTSCC; and
WHEREAS, LICENSEE is desirous
of obtaining a world-wide non-assignable (except as expressly
provided herein), royalty-bearing exclusive license, with the right
to grant sublicenses, under the BOARD Patent Rights and BOARD
Technical Information; and
WHEREAS, LICENSEE desires the
right to use the names Board of Regents, The University of Texas
System, M. D. Anderson Hospital and Tumor Institute, and The
University of Texas System Cancer Center for the purposes set forth
herein; and
WHEREAS, BOARD desires to
grant LICENSEE such a world-wide exclusive license, and the right
to use such names, under the following terms and
conditions;
NOW, THEREFORE, in
consideration of the foregoing, and the covenants and promises
contained herein, the sufficiency of which are hereby acknowledged
by the parties, BOARD, UTSCC and LICENSEE hereby agree as
follows:
I.
DEFINITIONS
A. The term
“Researchers/Inventors” when used herein shall mean
Roman Perez-Soler, M.D., Waldemar Priebe, Ph.D., Reeta T. Mehta,
Ph.D., Kapil Mehta, Ph.D. and/or Gabriel Lopez-Berestein,
M.D.
B. The term “Licensed
Subject Matter” shall mean liposomal encapsulated Nystatin
and other liposomal encapsulated polyene antibiotics (except
amphotericin B), liposomal encapsulated Anthracyclines, and
liposomal encapsulated retinoids, together with any invention,
discovery, know-how, process, procedure, method, protocol, formula,
technique, software, design, drawing, data, devices,
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specifications, sketches or other
technical information related thereto conceived, discovered, or
reduced to practice by the Researchers/Inventors, as of the date
hereof, irrespective of whether other persons jointly participate
in such conception, discovery or reduction to practice, and Related
Technology (as defined in Paragraph I.C. herein) to be conceived,
discovered, or reduced to practice as the result of funding
provided under LICENSEE’s sponsored research program, as
provided in the Research and Development Contract
(“R & D Contract”) between LICENSEE and UTSCC,
attached hereto as Exhibit I and incorporated herein, and all
processes, compositions, uses and Products resulting therefrom. The
term “Licensed Subject Matter” shall include the
patents, patent applications and areas of research listed on
Schedule I which is attached to this Agreement and incorporated
herein by reference for all purposes.
C. The term “Related
Technology” when used herein shall mean any invention,
discovery, know-how, trade secret, or technical information
conceived, discovered, or reduced to practice as the result of
funding under and during the term of the R & D
Contract.
D. The term “BOARD
Patent Rights”, when used herein, shall mean those United
States and foreign patents and patent applications or prospective
patent applications, which relate to the Licensed Subject Matter
(as defined in Paragraph I. B. herein), any technology that is an
infringement thereof (except as provided in Paragraph 5.5 of the R
& D Contract), and Improvements (as defined in Paragraph I. L.
herein) that are the subject of any patent or patent application,
in which BOARD now has or in the future acquires any interest
during the term of this Agreement or during the term and arising as
a result of the R & D Contract.
E. The term “BOARD
Technical Information”, when used herein, shall mean all
Licensed Subject Matter and all Improvements that are not subsumed
within the BOARD Patent Rights.
F. The term “Licensed
Patented Product or Process”, when used herein, shall mean
any product, apparatus, or process made, used, or marketed or sold
in any country where such product, apparatus or process is covered
by the claims of an issued patent or a pending patent application
included within the BOARD Patent Rights, together with any product
made by the use of any process in any country in which such process
or apparatus is covered by the claims of an issued patent or a
pending patent application included within the BOARD Patent
Rights.
G. The term “Licensed
Non-Patented Product or Process”, when used herein, shall
mean any product, apparatus or process utilizing or relating to the
Licensed Subject Matter which is manufactured, used, marketed or
sold with the use of any BOARD Technical Information which does not
utilize any BOARD Patent Rights, together with any product
utilizing the Licensed Subject Matter which is manufactured by a
process or apparatus which uses any BOARD Technical Information and
which does not utilize any BOARD Patent Rights.
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H. The term
“Process” when used herein shall mean and include the
manufacturing and utilization of the Licensed Patented Products or
Licensed Non-Patented Products for diagnostic or therapeutic
purposes.
I. The term
“Product” when used herein shall mean any Licensed
Patented Product or Process, and/or any Licensed Non-Patented
Product or Process, as said terms are defined herein.
J. The term “Net
Sales”, when used herein, shall mean the amount received or
collected by LICENSEE from commercial sales or other use or
disposition for value (including any marketing fees paid to
LICENSEE in connection with sales of Products, but not including
proceeds received from the sale of marketing rights as described in
Paragraph III.A.3 hereof), in bona fide arms-length transactions,
less (i) cash, trade and/or quantity discounts,
(ii) amounts repaid or credited by reason of rejections,
defects or returns or because of retroactive price reductions,
(iii) freight, transportation and freight insurance
(iv) sales and use taxes and (v) other charges which,
under generally accepted accounting principles, are deemed to be
incidental to the sale.
K. The term
“Subsidiary” shall mean a corporation, partnership,
association, trust or other legal entity which owns, controls, is
owned or controlled by, or is under common ownership or control of,
a party to this Agreement. For purposes of this definition,
“control” shall mean the ownership of such number of
outstanding shares or other interests aggregating more than 50% of
the ordinary voting power for the election of directors or the
exercise of control of such entity.
L. The term
“Improvement” where used herein means any change or
modification to the Licensed Subject Matter, and any compositions,
Products and uses resulting therefrom (together with all other
patents and patent applications, including any division,
continuation, continuation-in-part or reissue thereof, or
substitute therefor and the patents that may issue from such
changes or modifications), conceived, discovered, or reduced to
practice, in whole or in part by the Researchers/Inventors,
irrespective of whether other persons jointly participate in such
conception, discovery or reduction to practice, to the extent that
such change or modification relates to the Licensed Subject
Matter.
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II.
GRANT OF
RIGHTS
A. BOARD hereby grants to
LICENSEE and its Subsidiaries, for the term of this Agreement
(subject to the provisions of Paragraph VI.C. herein), an
exclusive, world-wide license, including the right to grant
sublicenses, under (1) the BOARD Patent Rights, (2) the
BOARD Technical Information, excluding from (1) and
(2) those Improvements first conceived after the termination
of the R & D Contract, and (3) Related Technology, to
manufacture, use, market and sell any Product throughout the United
States of America, its territories and possessions and in all
foreign countries.
B. UTSCC and BOARD hereby
grant to LICENSEE a right of first refusal to an exclusive,
world-wide, royalty bearing license for Improvements first
conceived after the termination of the R & D Contract but
before the termination of this Agreement, provided that the rights
to such Improvements are not already owned by a third party. UTSCC
and BOARD agree that they shall (1) refrain from disclosing
such Improvements to third parties (except as provided in Article V
herein) or entering into negotiations or agreements with third
parties with regard to the disposition of an Improvement except as
otherwise expressly permitted by this Agreement; and (2) give
LICENSEE prompt written notice of any such Improvement, which
notice shall specify all relevant technical and scientific
information pertaining to the Improvement in sufficient detail to
permit LICENSEE to reasonably assess its interest in the
Improvement and UTSCC’s projected research funding
requirements, if any (the “Improvement Notice”). If
LICENSEE delivers notice to UTSCC of its interest in an Improvement
(“Notice of Interest”) within 15 days after delivery of
the Improvement Notice, LICENSEE and UTSCC shall undertake
negotiations for the acquisition by LICENSEE of rights to such
Improvement. If LICENSEE fails to deliver a timely Notice of
Interest, or if UTSCC, Board and LICENSEE fail to enter into a
written agreement within 60 days after delivery of the Notice of
Interest or such additional time as may be agreed to by the
parties, Board and UTSCC shall be free to consult with and license
such Improvement to any other firm and LICENSEE shall have no
further rights to the Improvement. BOARD and UTSCC shall not enter
into any agreement with any other party unless such agreement is,
overall, more favorable to UTSCC than the last offered by
LICENSEE.
C. BOARD and UTSCC hereby
grant to LICENSEE the right to use the names “Board of
Regents, The University of Texas System”, “M. D.
Anderson Hospital and Tumor Institute” and “The
University of Texas System Cancer Center”
(“Names”) to the extent necessary to enforce and
protect LICENSEE’S rights under Board Patent Rights; and
subject to the written approval of UTSCC and, where required,
BOARD, to use the Names for such other purposes as UTSCC and BOARD
shall permit and may, under law, allow ; provided however, that
LICENSEE shall not be obligated to use such Names in any
manner.
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D. BOARD and UTSCC hereby
grant to LICENSEE the right of access to, during normal business
hours, and the use of, all experimental or other data which relate
in any manner to the BOARD Patent Rights or the BOARD Technical
Information, including without limitation, all data which BOARD has
provided to the United States Patent Office, the Food and Drug
Administration (FDA) or any other state, federal, foreign or local
regulatory authority which relate in any manner to the BOARD Patent
Rights or the BOARD Technical Information, and BOARD and UTSCC
agree that they will not use, or permit the use of, such
information and data, nor do anything else which will adversely
affect LICENSEE’S rights under this Agreement in any manner.
BOARD and UTSCC shall cooperate fully with LICENSEE, at
LICENSEE’S expense, in order to obtain the regulatory
approval of any state, federal, foreign or local authority which
now is or later becomes necessary to develop manufacture, use,
market or sell any Product. Such cooperation shall include, but not
be limited to, obtaining all necessary regulatory approvals which
are now required, or may in the future be required to manufacture,
use, market or sell any Product for use in any application thereof.
BOARD and UTSCC shall execute any and all documents reasonably
necessary to obtain such approvals upon request by LICENSEE.
LICENSEE shall reimburse BOARD and UTSCC for any reasonable
out-of-pocket costs, plus overhead not to exceed 50% of
out-of-pocket costs, including attorneys’ fees, incurred by
BOARD and UTSCC in connection with such cooperation. At such time
as clinical trials are commenced, LICENSEE agrees that it will
enter into an appropriate agreement with UTSCC regarding the
conduct of such trials but LICENSEE shall not be required to
conduct such trials at UTSCC.
E. UTSCC shall promptly
provide LICENSEE and shall continue to provide LICENSEE, during the
term of this Agreement, with all information relating to
(i) pharmacological, toxicological or clinical data,
(ii) synthetic, formulative, manufacturing or analytical data,
and (iii) such other chemical, physical or biological data
which UTSCC may now or in the future possess or control which
relates in any manner to the Licensed Subject Matter or
Improvements, except for that information made confidential by law
or prior agreement.
F. The parties recognize that
LICENSEE may encounter patents or other proprietary rights held by
third parties which dominate activities covered by the BOARD Patent
Rights or BOARD Technical Information, and that cross-licenses
between the BOARD (or LICENSEE) and such third parties may be
necessary in order to enable LICENSEE to exercise the rights
granted under this Agreement. In that event, LICENSEE has the right
to enter into cross-licensing agreements with third parties and to
grant cross-licenses under any or all of the BOARD Patent Rights or
BOARD Technical Information, provided:
1. BOARD and UTSCC are
consulted beforehand and are reasonably satisfied that the third
party does in fact hold a patent or own other proprietary rights
that limits LICENSEE’s ability to exercise the rights granted
herein.
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2. In BOARD’s and
UTSCC’s reasonable judgement, the rights received by LICENSEE
under such cross-licensing agreement cover only Licensed Patented
Products or Processes or Licensed Non-Patented Products or
Processes and are not directed to other products;
3. BOARD incurs no financial
or legal liabilities under the cross-licensing;
4. Any money or the value of
any equipment, including license issue fees (and not including
proceeds from sale of marketing rights as described in Paragraph
III.A.3.), received by LICENSEE in exchange for such
cross-licensing is treated as Net Sales for Products.
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III.
ROYALTIES AND
PAYMENTS
A. In consideration of the
grant by BOARD to LICENSEE of this license, LICENSEE shall pay to
UTSCC as follows:
1. For each Licensed Patented
Product or Process, an earned royalty as set forth in the schedule
below:
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Royalty Basis
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Royalty Rate |
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$0 - $10 million
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10 |
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$10 million - 35 million
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5 |
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Over $35 million
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3 |
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of the Net Sales made by
LICENSEE or its Subsidiaries in all countries where a patent
included within the BOARD Patent Rights issues, or a patent
application included within the BOARD Patent Rights has been filed
and is pending, with claims covering such Licensed Patented Product
or Process, until the expiration or other termination of such
patents or applications, or a determination of the invalidity or
unenforceability thereof by a court of final jurisdiction or the
determination that such patent will not issue.
For purposes of calculating
royalties under the above schedule (under this Paragraph III.A.1.
and the following Paragraph III.A.2.), and for reporting purposes
hereunder, each separate therapeutic drug, regardless of
application, shall be considered a single licensed Product or
Process, and all non-therapeutic Products and Processes shall be
considered in the aggregate as a single licensed Product or
Process.
2. An earned royalty of
one-half the rate described in Paragraph III.A.1., hereinabove, for
the same schedule of Net Sales for each Licensed Non-Patented
Product or Process by LICENSEE or its Subsidiaries during the term
of this Agreement. Further, and except as provided in Paragraph
III.A.4., if a Licensed Patented Product or Process becomes a
Licensed Non-Patented Product or Process (e.g. upon abandonment of
a previously pending patent application), the royalty basis shall
include Net Sales of said Product or Process made when said Product
or Process was a Licensed Patented Product or Process.
3. An earned royalty of forty
percent (40%) of the royalty received by the LICENSEE or its
Subsidiaries from their sublicensees hereunder, such royalty to be
measured upon and based on the actual proceeds received by LICENSEE
or its Subsidiaries under the sublicense agreement and not the
total Net Sales generated by the marketing or distribution of the
Products by the sublicensee. Such earned royalty shall be due for
as long as LICENSEE or its Subsidiary is receiving from the
sublicensee proceeds relating to the rights licensed hereunder, but
not in excess of the duration of this Agreement.
In addition, in the event
LICENSEE transfers or sells any of the marketing rights to any
Product to a non-related corporation, firm, association,
partnership, or other entity, the proceeds from such sale of
marketing rights is hereby expressly
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excluded from the terms of
this Article III, and no royalty payments shall be due thereon,
provided, however, that income to LICENSEE derived from the sales
of any Product by said entity, association, firm, partnership or
corporation shall be subject to the royalty provided in this
Paragraph III.A.3; and provided further, that the total royalty
under Paragraphs III.A.1., III. A.2. and III.A.3. shall not in any
event exceed that amount which would otherwise be due and payable
under Paragraphs III.A.1. or III.A.2., as the case may be, had such
royalties been paid on the ultimate sale of such Product in the
marketplace.
4. In no event will LICENSEE
be obligated to pay royalties under Paragraphs III.A.1., III.A.2.
or III.A.3 simultaneously for Net Sales of any particular Product
in any given country. A single royalty will be due on the sale of
each Product by LICENSEE or its Subsidiaries, no matter how many
items in the BOARD Patent Rights or BOARD Technical Information
cover such Product. No royalty shall be due or payable on a
Licensed Patented Product or Process after the BOARD Patent Rights
covering said Licensed Patented Product or Process have
expired.
5. Earned royalties in the
amount set out in Paragraph III.A.2. shall accrue in each country
only for the period that the LICENSEE is the exclusive commercial
source in that country of a Licensed Non- Patented Product or
Process. The term “exclusive commercial source” as used
above shall mean that the LICENSEE is the sole commercial source of
the Licensed Non-Patented Product or Process in that country and
that there is no commercial product available in that country that
is substantially equivalent in market acceptance, except as may
otherwise be provided, brought about, or allowed by LICENSEE. If
the LICENSEE believes that it is not the exclusive commercial
source of a Licensed Non-Patented Product or Process in any
designated country, then it shall also notify BOARD and provide
reasonable evidence thereto. Within 45 days of receipt of said
notice and evidence, BOARD shall notify the LICENSEE in writing of
its acceptance or rejection of the evidence as to the existence of
another commercial source. Upon acceptance by BOARD, the LICENSEE
shall, as of said date of acceptance, no longer have any obligation
to pay royalties on Net Sales in that country based on the amount
set out in Paragraph III.A.2. herein. In such event, the amount set
out in Paragraph III.A.2. shall be reduced to an amount equal to
one-third (1/3) of the applicable amount, and LICENSEE shall
pay such reduced royalty amount.
6. Except as provided in
Paragraph VI. C., below, BOARD understands that, in order to
successfully market Products and Processes covered by this
Agreement, LICENSEE makes no warranty that it will market the
Products or Processes covered by this Agreement or, if LICENSEE
does market any of such Products or Processes, that they will be
the exclusive means by which LICENSEE will participate in this
field. All business decisions relating to use, manufacture, sale or
marketing of Products covered under this Agreement will be within
the sole discretion of LICENSEE.
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7. In the event that LICENSEE
enters into a joint venture with another entity and utilizes the
rights granted herein in combination with the technology of such
entity or any of LICENSEE’s technology not subject to this
Agreement, then Net Sales for purposes of calculating royalties as
provided in Paragraphs III.A.1 or III.A.2. hereunder, as the case
may be, shall be deemed to be LICENSEE’s income received from
such joint venture that is derived from utilization of the rights
granted herein.
8. Where a Product is not
sold separately but is sold in combination with or as part of other
products, the Net Sales of the Product so sold shall be calculated,
for the purpose of computing royalties due, by applying to the
total selling price of the combination or composite product a
fractional multiplier having as its denominator the total selling
price of the combined or co
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