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EXHIBIT 10.59
PATENT AND TECHNOLOGY LICENSE
AGREEMENT
This thirty-one (31) page
AGREEMENT ("AGREEMENT") is made on this 30 th day of September, 2006, by and
between THE BOARD OF REGENTS ("BOARD") of THE UNIVERSITY OF TEXAS
SYSTEM ("SYSTEM"), an agency of the State of Texas, whose address
is 201 West 7 th
Street, Austin, Texas 78701, on behalf of THE
UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER ("UTMDACC"), a
component institution of SYSTEM, and Introgen Therapeutics, Inc., a
Texas corporation having a principal place of business located at
301 Congress, Suite 1850, Austin, Texas 78701
("LICENSEE").
RECITALS
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A.
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BOARD owns certain PATENT RIGHTS and TECHNOLOGY
RIGHTS related to LICENSED SUBJECT MATTER developed at
UTMDACC.
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B.
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BOARD, through UTMDACC, desires to have the
LICENSED SUBJECT MATTER developed in the LICENSED FIELD and used
for the benefit of LICENSEE, BOARD, SYSTEM, UTMDACC, the
inventor(s), and the public as outlined in BOARD’s
Intellectual Property Policy.
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C.
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LICENSEE wishes to obtain a license from BOARD to
practice LICENSED SUBJECT MATTER.
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NOW, THEREFORE, in consideration of the mutual
covenants and promises herein contained, the parties agree as
follows:
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I. EFFECTIVE
DATE
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1.1
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This AGREEMENT is effective as of the date first
listed above ("EFFECTIVE DATE").
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II. DEFINITIONS
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As used in this AGREEMENT, the following terms
have the meanings indicated:
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2.1
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AFFILIATE means any business entity
more than fifty percent (50%) owned by LICENSEE, any business
entity which owns more than fifty percent (50%) of LICENSEE, or any
business entity that is more than fifty percent (50%) owned by a
business entity that owns more than fifty percent (50%) of
LICENSEE.
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2.2
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LICENSED FIELD means [*].
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2.3
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LICENSED PRODUCTS means any product or
service sold by LICENSEE, its AFFILIATES or SUBLICENSEES comprising
LICENSED SUBJECT MATTER pursuant to this AGREEMENT.
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2.4
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LICENSED SUBJECT MATTER means
inventions and discoveries covered by PATENT RIGHTS or TECHNOLOGY
RIGHTS within LICENSED FIELD.
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2.5
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LICENSED TERRITORY means [*].
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2.6
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MAJOR MARKET COUNTRIES means,
collectively, all of the United States, Japan and at least four of
the following countries in Europe: United Kingdom, France, Germany,
Spain, Italy, Sweden and Switzerland.
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2.7
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NET SALES means the gross revenues
received by LICENSEE, its AFFILIATES or SUBLICENSEES from a SALE
less sales discounts actually granted, sales and/or use taxes
actually paid, import and/or export duties actually paid, outbound
transportation actually prepaid or allowed, and amounts actually
allowed or credited due to returns (not exceeding the original
billing or invoice amount), all as recorded by LICENSEE, AFFILIATES
or SUBLICENSEES in their official books and records in accordance
with generally accepted
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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accounting practices and consistent with their
published financial statements and/or regulatory filings with the
United States Securities and Exchange Commission.
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2.8
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PATENT RIGHTS means (a) all of
BOARD’s rights in and to any patents and patent applications,
whether domestic or foreign, that claim any invention, information
or discovery described in any of the invention disclosures defined
in Exhibit I attached hereto, including the patent application
listed in Exhibit I, and all patents, whether domestic or
foreign that issue thereon; and (b) all divisionals,
continuations, continuations-in-part (to the extent the claims of
such continuations-in-part are entitled to claim priority to the
aforesaid patents and/or patent applications defined in clause
(a)), reissues, reexaminations or extensions of the patents and
patent applications defined in clause (a), and any letters patent,
domestic or foreign that issue thereon. From time to time during
the term of this AGREEMENT, upon request by either party, LICENSEE
and BOARD shall promptly update Exhibit I to include all
patent applications and patents that are within PATENT
RIGHTS.
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2.9
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SALE or SOLD means the transfer or
disposition of a LICENSED PRODUCT for value (or, with respect to
LICENSED PRODUCTS that are services, the provision of such services
for value on a fee-for-services basis) to a party other than
LICENSEE, an AFFILIATE or a ROYALTY-FREE PRACTITIONER. As used
herein, "ROYALTY-FREE PRACTITIONER" means UTMDACC and Jack Roth,
M.D. ( the "PHYSICIAN INVENTOR"), and any partner or associate who
practices medicine with one or more of the PHYSICIAN INVENTOR, but
with respect to such partner or associate, only for such time as
they are engaged in a bona fide medical practice with one or more
of the PHYSICIAN INVENTOR.
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2.10
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SUBLICENSEE means any third party to
whom LICENSEE has granted a sublicense under the LICENSED SUBJECT
MATTER to make and sell LICENSED PRODUCTS, with respect to LICENSED
PRODUCTS made and sold by such SUBLICENSEE. As used herein,
"SUBLICENSEE" shall also mean a third party to whom LICENSEE has
granted the exclusive right to distribute LICENSED PRODUCTS
supplied by LICENSEE, provided that such third party is responsible
for all marketing and promotion of the subject LICENSED PRODUCTS
within its exclusive territory.
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2.11
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SUBLICENSE INCOME means all
consideration received by LICENSEE from a SUBLICENSEE in
consideration of a sublicense of the LICENSED SUBJECT MATTER,
including but not limited to, up-front payments, marketing,
distribution, franchise, option, license, or documentation fees,
bonus and milestone payments and equity securities. SUBLICENSE
INCOME shall specifically exclude: (i) payments received by
LICENSEE from a sublicense as a result of the purchase or sale of
debt or equity securities of LICENSEE by such sublicense, and
(ii) payments for research and development of the LICENSED
PRODUCTS; and (iii) any royalties that LICENSEE receives for
the SUBLICENSEE’S sale of LICENSED PRODUCTS (which are
captured under Section 4.1 (d)).
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2.12
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TECHNOLOGY RIGHTS means BOARD’S
rights in any technical information, knowhow, processes,
procedures, compositions, devices, methods, formulae, protocols,
techniques, software, designs, drawings or data created by the
inventor(s) listed in Exhibit I, or those working in the lab
or under the supervision or direction of one or more of the
inventor(s) listed in Exhibit I, at UTMDACC before the
EFFECTIVE DATE, whether or not
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claimed in PATENT RIGHTS but that are reasonably
necessary for practicing an invention at any time claimed in the
PATENT RIGHTS.
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2.13
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VALID CLAIM means either (a) a
claim of an issued and unexpired patent included within the PATENT
RIGHTS which has not been held unenforceable, unpatentable or
invalid by the final decision of a court or other governmental
agency of competent jurisdiction, in which such decision is
unappealable or unappealed within the time allowable for appeal,
and which has not been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise, or (b) a pending claim in
a patent application within the PATENT RIGHTS, provided that if
such pending claim has not issued as a claim or an issued patent
within the PATENT RIGHTS within five (5) years after the
filing of the application in which such claim first appears, such
pending claim shall not be a VALID CLAIM for purposes of this
AGREEMENT, unless and until subsequent to such five (5) year
period, such pending claim is issued as a claim of an issued and
unexpired patent included within the PATENT RIGHTS as set forth in
(a) above.
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III. LICENSE
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3.1
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BOARD, through UTMDACC, hereby grants to LICENSEE
a [*] license under LICENSED SUBJECT MATTER to [*] LICENSED
PRODUCTS, to [*] the LICENSED SUBJECT MATTER, in each case within
LICENSED TERRITORY for use within LICENSED FIELD. This grant is
subject to Sections 14.2 and 14.3 herein below, the payment by
LICENSEE to UTMDACC of all consideration as provided herein, and is
further subject to the following rights retained by BOARD and
UTMDACC to:
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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(a)
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Publish the general, scientific findings from
research related to LICENSED SUBJECT MATTER, subject to the terms
of Article XI-Confidential Information and Publication;
and
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(b)
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Use LICENSED SUBJECT MATTER for research,
teaching, patient care, and other educationally-related purposes;
and
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(c)
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Transfer LICENSED SUBJECT MATTER to academic or
research institutions for non-commercial research use.
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3.2
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LICENSEE may extend the license granted herein to
any AFFILIATE provided that the AFFILIATE consents in writing to be
bound by this AGREEMENT to the same extent as LICENSEE. LICENSEE
agrees to deliver such contract to UTMDACC within thirty
(30) calendar days following execution thereof.
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3.3
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LICENSEE may grant and authorize sublicenses
under LICENSED SUBJECT MATTER consistent with the terms of this
AGREEMENT. LICENSEE is responsible to use commercially reasonable
efforts to cause its SUBLICENSEES to comply with the relevant
obligations under this AGREEMENT, and for diligently collecting all
amounts due LICENSEE from SUBLICENSEES. If a SUBLICENSEE pursuant
hereto becomes bankrupt, insolvent or is placed in the hands of a
receiver or trustee, LICENSEE, to the extent allowed under
applicable law and in a timely manner, agrees to use its reasonable
efforts to collect all consideration owed to LICENSEE and to have
the sublicense agreement confirmed or rejected by a court of proper
jurisdiction.
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3.4
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LICENSEE must deliver to UTMDACC a true and
correct copy of each sublicense granted by LICENSEE, and any
modification or termination thereof, within thirty
(30) calendar days after execution, modification, or
termination.
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3.5
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If this AGREEMENT is terminated pursuant to
Article XIII-Term and Termination, all sublicenses granted
hereunder that are in compliance with their terms shall survive the
termination provided that each such SUBLICENSEE consents in writing
to be bound directly to BOARD and UTMDACC to all of the terms and
conditions of this AGREEMENT, subject to any field of use or
jurisdictional limitations provided in the original sublicense;
provided that in such case the SUBLICENSEE’S obligation to
pay the costs of searching, preparing, filing, prosecuting and
maintaining the LICENSED SUBJECT MATTER would, notwithstanding
Article XI, be limited to a percentage of such costs based on
the number of licensees of such LICENSED SUBJECT MATTER. For
example, if there were four licensees, the percentage would be
25%.
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IV. CONSIDERATION, PAYMENTS AND
REPORTS
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4.1
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In consideration of rights granted by BOARD to
LICENSEE under this AGREEMENT, LICENSEE agrees to pay UTMDACC the
following:
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(a)
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All [*], for so long as, and in such countries as
this AGREEMENT remains in effect. UTMDACC will invoice LICENSEE
after the AGREEMENT has been fully executed by all parties for
expenses incurred as of that time and on a quarterly basis
thereafter. The invoiced amounts will be due and payable by
LICENSEE within thirty (30) calendar days of invoice;
and
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(b)
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a [*] fee in the amount of [*]. This fee will not
reduce the amount of any other payment provided for in this ARTICLE
IV, and is due and payable within thirty (30) calendar days
after the AGREEMENT has been fully executed by all parties and
LICENSEE has received an invoice for the amount from UTMDACC;
and
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(c)
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[*] due and payable as follows until the first
SALE:
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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§
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First, second and third anniversary of the
EFFECTIVE DATE: [*];
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Fourth, fifth sixth and seventh anniversary of
the EFFECTIVE DATE: [*];
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Eighth and all subsequent anniversaries of the
EFFECTIVE DATE until first SALE: [*] (collectively, the "Annual
Maintenance Fee").
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The Annual Maintenance Fees will be due without
invoice within thirty (30) days of each anniversary of the
EFFECTIVE DATE until first SALE and will not reduce the amount of
any other payment provided for in this ARTICLE IV; and
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(d)
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A running royalty equal to [*] attributed to
SALES of LICENSED PRODUCTS by LICENSEE, AFFILIATES and
SUBLICENSEES, subject to the following:
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It is understood that royalties shall be due
under this Section 4.l(d) above only on SALES of LICENSED
PRODUCTS, the SALE of which would, but for the license granted
herein, infringe a VALID CLAIM in the country for which such
LICENSED PRODUCT is SOLD. However, if the SALE of a LICENSED
PRODUCT would infringe a VALID CLAIM in the MAJOR MARKET COUNTRIES,
LICENSEE shall pay royalties hereunder on all sales of such
LICENSED PRODUCT in any country, regardless of whether the sale of
such product in such country would infiinge a VALID
CLAIM.
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§
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In the event that more than one patent within the
PATENT RIGHTS is applicable to any LICENSED PRODUCT subject to
royalties under this Section 4.l(d), then only one royalty
shall be paid to UTMDACC in respect of such quantity of the
LICENSED PRODUCTS and in any event
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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no more than one royalty will be payable
hereunder with respect to any particular LICENSED PRODUCT
unit;
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No royalty shall be payable under this
Section 4.1 (d) with respect to the SALE of LICENSED
PRODUCTS between or among LICENSEE, AFFILIATES and SUBLICENSEES,
provided that such LICENSED PRODUCTS are to be resold to unrelated
third parties, or with respect to any fees or other payments paid
between or among LICENSEE and AFFILIATES; nor shall a royalty be
payable under this Section 4. 1(d) with respect to SALES of
LICENSED PRODUCTS for use in clinical trials or as
samples;
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In the event that a LICENSED PRODUCT is sold in
combination as a single product, or in a kit, with another product
or component and no royalty would be due hereunder on the sale of
such other product or component alone, then NET SALES from such
combination sales for purposes of calculating the amounts due under
this Section 4.l(d) shall be as reasonably allocated, as
determined in good faith by LICENSEE and UTMDACC, between such
LICENSED PRODUCT and such other product or components, based upon
their relative importance and proprietary protection as
commercially reasonable;
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To the extent that the LICENSEE is required, by
order or judgment of any court to obtain in any jurisdiction any
license from a third party in order to practice the rights granted
to the LICENSEE hereunder, or LICENSEE otherwise reasonably
determines that such a license is necessary, then up to [*] may be
deducted from royalties otherwise payable to UTMDACC
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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from the LICENSEE in that jurisdiction, provided
that in no event shall the royalties payable to UTMDACC pursuant to
this Section 4.l(d) in any quarterly period in such
jurisdiction be reduced by [*]; and
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Notwithstanding the foregoing, if SALES of a
LICENSED PRODUCT subject to royalty obligations under this Section
4.l(d) are also subject to a royalty under one or more other
agreements entered into by Introgen Therapeutics, Inc. and UTMDACC,
LICENSEE may reduce the royalties payable hereunder by fifty
percent (50%) with respect to SALES of such LICENSED PRODUCT. To
the extent such other agreements do not provide for a corresponding
fifty percent (50%) reduction in the royalties payable thereunder
to account for royalties payable under this AGREEMENT, they shall
by this AGREEMENT be deemed amended to provide for such
corresponding fifty percent (50%) reduction in the royalties
payable thereunder; and
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(e)
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After first SALE, minimum annual royalties of
[*]. This amount shall be due and payable within thirty
(30) days of the first and all subsequent anniversaries of the
EFFECTIVE DATE which follows the first SALE ("Minimum Annual
Royalties"); provided, however, that in the event that there is
less than a twelve month period between the first SALE and the
first anniversary of the EFFECTIVE DATE which follows the first
SALE, then LICENSEE shall pay the following: (1) the Annual
Maintenance Fee due for that year multiplied by the fraction, A/C,
where A is the number of months between the anniversary of the
EFFECTIVE DATE preceding the first SALE and the first SALE and C is
twelve (12); and (2) the Minimum Annual
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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Royalty multiplied by the fraction B/C, where B
is the number of months between the first SALE and the first
anniversary of the EFFECTIVE DATE which follows the first SALE, C
is twelve and A + B = twelve (12). Additionally, running royalties
accrued under Section 4.l(d) and paid to UTMDACC during the
one year period preceding an anniversary of the EFFECTIVE DATE
shall be credited against the Minimum Annual Royalties due on that
anniversary date; and
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(f)
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the following percentage of SUBLICENSE INCOME
received by LICENSEE:
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§
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[*] of SUBLICENSE INCOME received by the LICENSEE
from the EFFECTIVE DATE until the [*] anniversary thereof;
and
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§
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[*] of SUBLICENSEE INCOME received by LICENSEE on
and after the [*] anniversary of the EFFECTIVE DATE until the
termination or expiration of this AGREEMENT.
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Additionally, the maximum payment to UTMDACC
under this Section 4.l(f) for each sublicense agreement is
[*].
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4.2
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Unless otherwise provided, all such payments are
payable within thirty (30) calendar days after March 31,
June 30, September 30, and December 31 of each year
during the term of this AGREEMENT, at which time LICENSEE will also
deliver to UTMDACC a true and accurate report, giving such
particulars of the business conducted by LICENSEE, its AFFILIATES
and its SUBLICENSEES, if any exist, during the preceding three
(3) calendar months under this AGREEMENT as necessary for
UTMDACC to account for LICENSEE’s payments hereunder. This
report will include pertinent data, including, but not limited
to:
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(a)
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the accounting methodologies used to account for
and calculate the items included in the report and any differences
in such accounting methodologies used by LICENSEE since the
previous report; and
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[*] Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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(b)
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a list of LICENSED PRODUCTS produced for the
three (3) preceding calendar months; and
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(c)
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the total quantit
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