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Exhibit 10.11
PATENT AND TECHNOLOGY LICENSE AGREEMENT
THIS AGREEMENT ("AGREEMENT") is made 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 000 Xxxx 0xx Xxxxxx, Xxxxxx, Xxxxx 00000, THE
UNIVERSITY OF TEXAS M.D. XXXXXXXX CANCER CENTER ("MDA"), a component institution
of the SYSTEM and INTRON THERAPEUTICS, INC., a Texas corporation having a
principal place of business located at 000 Xxxxxxxx, Xxxxx 0000, Xxxxxx, Xxxxx
00000 ("LICENSEE").
RECITALS
A. BOARD owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER, which were developed at MDA, a component institution of
the SYSTEM.
B. BOARD desires to have the LICENSED SUBJECT MATTER developed and used for
the benefit of LICENSEE, the inventor, BOARD, and the public as outlined
in the Intellectual Property Policy promulgated by the BOARD.
C. The LICENSED SUBJECT MATTER was the subject of an OPTION AGREEMENT between
MDA and the Texas Biomedical Development Partners ("TBDP"), dated December
15, 1992, a copy of which is attached hereto as Exhibit 1 for approval by
BOARD, granting TBDP the option to negotiate a license from BOARD to the
LICENSED SUBJECT MATTER in consideration for an option fee and commitment
of research support.
D. TBDP exercised its option under the OPTION AGREEMENT in a timely manner by
virtue of the letter dated June 17, 1993, a copy of which is attached
hereto as Exhibit 2 for approval by BOARD, and further assigned TBDP's
right and obligations under the OPTION AGREEMENT (Exhibit 1) to LICENSEE,
thereby granting permission to BOARD to execute this LICENSE AGREEMENT
with LICENSEE.
E. The LICENSED SUBJECT MATTER was also the subject of SPONSORED RESEARCH
AGREEMENTS between MDA and the TBDP, entitled "Development of Therapeutic
Treatment and Prevention of Lung Cancer" (SR93-04) and "Clinical Protocol
for Modification of Oncogene and Tumor Suppressor Gene Expression in
Nori-Small Cell Lung Cancer (CS93-27), respectively, and a copy of each is
attached hereto as Exhibits 3 and 4 (the "RESEARCH AGREEMENTS").
F. The RESEARCH AGREEMENTS have been assigned by TBDP to LICENSEE by virtue
of a letter dated November 26, 1993, a copy of which is attached hereto as
Exhibit 5 for approval by BOARD.
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G. LICENSEE is a company which was formed to develop and commercially exploit
the inventions of LICENSED SUBJECT MATTER, and LICENSEE, therefore, wishes
to obtain a license from BOARD to practice LICENSED SUBJECT MATTER.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein
contained, the parties hereto agree as follows:
I. EFFECTIVE DATE
1.1 This AGREEMENT shall be effective as of July 20, 1994 ("EFFECTIVE DATE"),
subject to approval by BOARD.
II. DEFINITIONS
As used in this AGREEMENT, the following terms shall have the meanings
indicated:
2.1 LICENSED FIELD shall mean all fields of use of the LICENSED SUBJECT
MATTER.
2.2 LICENSED SUBJECT MATTER shall mean inventions and discoveries covered by
PATENT RIGHTS or TECHNOLOGY RIGHTS within LICENSED FIELD.
2.3 PATENT RIGHTS shall mean any and all rights of BOARD in and to:
(a) the patents and patent applications described in Schedule A
hereto (the "Existing Patent Rights") and all patents anywhere in the
world issuing thereon;
(b) any patent or patent application of any kind anywhere in the
world that claims or discloses any invention that is claimed in any of the
Existing Patent Rights, or that takes priority from an application within
the Existing Patent Rights or derives from an application from which any
of the Existing Patent Rights derived;
(c) all divisions, continuations, continuations-in-part, patents of
addition, patents, substitutions, registrations, reissues, reexaminations
or extensions of any kind with respect to any of the applications and
patents described in (a) or (b) above. From time to time during the term
of this AGREEMENT, upon request by either party, LICENSEE and BOARD shall
promptly update Schedule A hereto to include all patent applications and
patents that are then within the PATENT RIGHTS.
2.4 TECHNOLOGY RIGHTS shall mean BOARD's rights in any technical information,
know-how, process, procedure, composition, biological materials, device,
method, formula, protocol, technique, software, design, drawing or data
relating to LICENSED FIELD and made or developed by Xx. Xxxx X. Xxxx or
others working in his lab or under his supervision or direction, whether
or not covered by PATENT RIGHTS, which is reasonably necessary for
practicing an invention at any time covered by PATENT RIGHTS.
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2.5 LICENSED PRODUCT shall mean any product, component or material the
manufacture, use or sale of which would infringe a VALID CLAIM.
2.6 LICENSED TERRITORY shall mean the entire world.
2.7 SALE or sold shall mean the transfer or disposition of a LICENSED PRODUCT
for value to a party other than LICENSEE or an AFFILIATE, which transfer
or disposition would, but for the rights and license granted hereunder,
infringe a VALID CLAIM in the country for which such LICENSED PRODUCT is
transferred or disposed.
2.8 NET SALES shall mean the gross revenues received by LICENSEE, its
AFFILIATES or SUBLICENSEES, from the SALE of LICENSED PRODUCTS less sales
and/or use taxes actually paid, import and/or export duties actually paid,
outbound transportation prepaid or allowed, and amounts allowed or
credited due to returns (not to exceed the original billing or invoice
amount).
2.9 AFFILIATE shall mean any business entity more than 50% owned by LICENSEE,
or any business entity that is more than 50% owned by a business entity
that owns more than 50% of LICENSEE.
2.10 VALID CLAIM shall mean 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 a court or other governmental
agency of competent jurisdiction, 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 [*] after the filing date from which such
patent application takes priority, such pending claim shall not be a VALID
CLAIM for purposes of this AGREEMENT unless and until, subsequent to [*]
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. In the
event that a claim of an issued and unexpired patent within the PATENT
RIGHTS is held by a court or other governmental agency of competent
jurisdiction to be unenforceable, unpatentable or invalid, and such
holding is reversed on appeal by a higher court or agency of competent
jurisdiction, such claim shall be reinstated thereafter as a VALID CLAIM
hereunder.
2.11 SUBLICENSEE shall mean any third party to whom LICENSEE has granted a
sublicense under the PATENT RIGHTS 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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III. WARRANTY: SUPERIOR-RIGHTS
3.1 Except for the rights, if any, of the Government of the United States as
set forth hereinbelow, BOARD represents and warrants its belief that it is
the owner of the entire right, title, and interest in and to LICENSED
SUBJECT MATTER, and that it has the sole right to grant licenses
thereunder, and that it has not granted licenses thereunder to any other
entity that would restrict rights granted hereunder except as stated
herein. In addition, BOARD represents and warrants that it owns and will
own all right, title and interest in and to the patent applications listed
in Exhibit A as of the Effective Date, and all patents that will issue
thereon; and that the patents listed on Exhibit A comprise all patents and
applications owned by BOARD or MDA that claim inventions of any of the
inventors listed therein which pertain to the p53 gene or K-ras or gene
therapy.
3.2 LICENSEE understands that the LICENSED SUBJECT MATTER may have been
developed under a funding agreement with the Government of the United
States of America and, if so, that the Government may have certain rights
relative thereto. This AGREEMENT is explicitly made subject to the
Government's rights under any such agreement and any applicable law or
regulation, including P.L. 96-517 as amended by P.L. 98-620. To the extent
that there is a conflict between any such agreement, applicable law or
regulation and this Agreement, the terms of such Government agreement,
applicable law or regulation shall prevail.
3.3 BOARD, by this AGREEMENT, makes no representation as to the patentability,
validity, and/or breadth of the inventions contained in the PATENT RIGHTS.
BOARD, by this AGREEMENT, makes no representation as to whether there are
any patents now held, or which will be held, by others or by BOARD in the
LICENSED FIELD, nor does BOARD make any representation that the inventions
contained in PATENT RIGHTS do not infringe any other patents now held or
that will be held by others or by BOARD.
IV. LICENSE
4.1 BOARD hereby grants to LICENSEE a royalty-bearing, exclusive license under
the LICENSED SUBJECT MATTER to manufacture, have manufactured, use and/or
sell LICENSED PRODUCTS, to practice any method, process or procedure and
to otherwise exploit the LICENSED SUBJECT MATTER, within LICENSED
TERRITORY for use within LICENSED FIELD. Subject to Paragraph 5.8 herein,
such license shall extend to BOARD's undivided interest in any LICENSED
SUBJECT MATTER developed during the term of this AGREEMENT and jointly
owned by BOARD and LICENSEE. This grant shall be subject to Paragraph 3.2,
hereinabove, the payment by LICENSEE to BOARD of all consideration as
provided in this AGREEMENT, including the timely payment of all amounts
due during the term of this Agreement under any sponsored research
agreement covering the Licensed Subject Matter between MDA and LICENSEE
(including but not limited to the RESEARCH AGREEMENTS, reimbursement of
MDA's patent expenses as set forth in Paragraph 5.7 below, and shall be
further subject to rights retained by BOARD and MDA to:
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(a) Publish the general scientific findings from research related to
LICENSED SUBJECT MATTER; and
(b) Use any information contained in LICENSED SUBJECT MATTER for
research, teaching, patient care, and other educationally-related
purposes.
Notwithstanding the foregoing, the license granted in this Section 4.1
under TECHNOLOGY RIGHTS not covered by any PATENT RIGHTS shall be
non-exclusive for all applications that do not pertain in any way to the
p53 gene, the k-ras gene, or mutations thereof, the genetic or functional
inhibition or promotion thereof; the translation or transcription pathways
of such genes or mutations thereof, or any protein or molecule expressed
by such genes or mutations thereof.
4.2 LICENSEE shall have the right to extend the license granted herein to any
AFFILIATE provided that such AFFILIATE consents in writing, with copy to
BOARD, to be bound by this AGREEMENT to the same extent as LICENSEE.
4.3 The license granted under Paragraph 4.1 above shall include the rights to
grant and authorize sublicenses within the scope of the right and license
granted to LICENSEE. LICENSEE shall monitor the operations of its
SUBLICENSEES in connection with the obligations of LICENSEE pursuant to
this AGREEMENT, and shall use reasonable efforts to ensure that such
SUBLICENSEES comply fully with such obligations. LICENSEE shall promptly
inform BOARD of the name and address of each such SUBLICENSEE, and subject
to any obligations of confidentiality to the SUBLICENSEE, shall provide
MDA a copy of the sublicense agreement.
V. PAYMENTS AND REPORTS
5.1 In consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT, LICENSEE agrees to pay MDA the following:
(a) [*] of NET SALES attributed to SALES of LICENSED PRODUCTS by
LICENSEE, AFFILIATES and SUBLICENSEES; and
(b) For any advance payment received by LICENSEE from a third party
pursuant to a sublicense, marketing, distribution, or franchise
agreement, other than amounts paid to LICENSEE in reimbursement of
development or other costs, as provided for in Article 4.3 hereof
and which is creditable against future royalties to be received by
LICENSEE:[*] of said advance payment.
(c) LICENSEE will not be obligated to pay MDA any portion of any
advanced payment received by LICENSEE from a third party [*].
(d) If LICENSEE desires to fund sponsored research, and particularly
where LICENSEE receives R&D money in lieu of or in addition to
royalty revenues pursuant to a sublicense, LICENSEE shall give good
faith consideration to funding such proposals at MDA.
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5.2 In the event that more than one patent within the PATENT RIGHTS is
applicable to any LICENSED PRODUCT subject to royalties under this Article
V, then only one royalty shall be paid to MDA in respect of such quantity
of the LICENSED PRODUCTS and in any event no more than one royalty will be
payable hereunder with respect to any particular LICENSED PRODUCT unit. In
addition:
(a) No royalty shall be payable under Paragraph 5.1 above 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 Paragraph 5.1 with
respect to SALES of LICENSED PRODUCTS for use in clinical trials or
as samples.
(b) 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 Article V shall
be as reasonably allocated by LICENSEE between such LICENSED PRODUCT
and such other product or components, based upon their relative
importance and proprietary protection as commercially reasonable.
5.3 During the Term of this AGREEMENT and for [*] thereafter, LICENSEE shall
keep complete and accurate records if its SALES and NET SALES of LICENSED
PRODUCTS and other income subject to royalties hereunder and all revenues
received from all SUBLICENSEES to enable the royalties payable hereunder
to be determined. LICENSEE shall permit BOARD or its representatives, at
BOARD's expense, to periodically examine its books, ledgers, and records
during regular business hours for the purpose of and [*] are determined to
have been underpaid LICENSEE shall pay the cost of such examination, and
accrued interest at the highest allowable rate.
5.4 Within [*] after March 31, June 30, September 30, and December 31,
LICENSEE shall deliver to BOARD and MDA a true and accurate report, giving
such particulars of the business conducted, if any, by LICENSEE, including
all revenues received from all SUBLICENSEES, during the preceding three
(3) calendar months under this AGREEMENT as are pertinent to an account
for payments hereunder. Such report shall include at least (a) the
quantities of LICENSED SUBJECT MATTER that it has produced; (b) the total
SALES, (c) the calculation of royalties thereon; and (d) the total
royalties so computed and due BOARD. Simultaneously with the delivery of
each such report, LICENSEE shall pay to BOARD the amount, if any, due for
the period of such report. If no payments are due, it shall be so
reported.
5.5 Upon the request of BOARD or MDA but not more often than once per calendar
year, LICENSEE shall deliver to BOARD and MDA a written report as to
LICENSEE's efforts and accomplishments during the preceding year in
commercializing LICENSED SUBJECT MATTER
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in various parts of the LICENSED TERRITORY and its commercialization plans
for the upcoming year.
5.6 All amounts payable hereunder by LICENSEE shall be payable in United
States funds. Checks shall be made payable to The University of Texas M.D.
Xxxxxxxx Cancer Center. Any withholding or other tax that LICENSEE, an
AFFILIATE, or a SUBLICENSEE are required by law to withhold shall be
deducted from royalties owing to MDA hereunder and promptly paid to the
taxing authority. If royalties paid to LICENSEE or an AFFILIATE by a
SUBLICENSEE on NET SALES of LICENSED PRODUCTS are reduced for withholding
or similar taxes, LICENSEE may deduct a portion of such tax from the
royalties payable to UNIVERSITY with respect to such Net Sales; the
portion to be so deducted shall equal the amount of the tax multiplied by
the fraction B/A, where "A" equals the gross royalty payable to LICENSEE
on such Net Sales prior to the withholding or similar tax, and "B" equals
the gross royalty payable to UNIVERSITY on such Net Sales prior to the
reduction under this Section 5.6. In regard to any tax so deducted,
LICENSEE shall furnish UNIVERSITY with proper evidence of the taxes paid.
In the event that LICENSEE realizes a reduction in its U.S. tax liability
by reason of a foreign tax credit with respect to withholding taxes so
deducted from royalties payable to MDA hereunder, LICENSEE shall pay to
MDA the amount of such reduction in its U.S. tax liability.
5.7 LICENSEE shall reimburse MDA [*] in filing, prosecuting, enforcing and
maintaining PATENT RIGHTS exclusively licensed hereunder and which were
not already reimbursed pursuant to the Option Agreement in Exhibit I
hereto, and shall pay all such future expenses so long as and in such
countries as [*]. In the event that LICENSEE notifies MDA that it does not
wish to reimburse further expenses of prosecuting or maintaining any
application or patent within the PATENT RIGHTS in any country, LICENSEE
shall not be responsible for any such expenses with respect to such
application or patent after MDA's receipt of such notice, and LICENSEE's
license under Paragraph 4.1 above shall become nonexclusive with respect
to such application (and any patent issuing thereon) or patent in such
country. MDA will invoice LICENSEE on a quarterly basis beginning October
1, 1994,[*].
5.8 No payments due or royalty rates under this AGREEMENT shall be reduced as
the result of co-ownership of LICENSED SUBJECT MATTER by BOARD and
LICENSEE.
5.9 It is understood that royalties shall be due under 5.1(a) above only on
SALES of LICENSED PRODUCTS, the SALE of which [*]. However, if the SALE of
a LICENSED PRODUCT [*], 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 infringe a VALID CLAIM. [*]
5.10 Effective upon written notice to MDA, LICENSEE may convert the license
granted to LICENSEE under Paragraph 4.1 with respect to any patent or
application within the PATENT RIGHTS to a non-exclusive license. Following
such notice, the amounts to be paid to MDA under Paragraph 5.1 above with
respect to any VALID CLAIMS within such patent or application, after any
other adjustment under this AGREEMENT, shall be [*].
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VI. PATENTS AND INVENTIONS
6.1 If [*] it is agreed by BOARD and LICENSEE that a new patent application
should be filed for LICENSED SUBJECT MATTER, [*] will prepare and file
appropriate patent applications, and [*] will pay the cost of searching,
preparing, filing, prosecuting and maintaining same, subject to Paragraph
5.7 above. [*] shall provide [*] with a copy of the new patent application
for which [*] has paid the cost of filing, as well as copies of any
documents received or filed during prosection thereof. [*] shall consult
with [*] in a timely manner concerning (i) scope and content of all patent
applications within the PATENT RIGHTS prior to filing such patent
applications, and (ii) content of and proposed responses to official
actions of the United States Patent and Trademark Office and foreign
patent offices during prosecution of any patent applications within the
PATENT RIGHTS. For purposes of this Paragraph 6.1, "timely" shall mean
sufficiently in advance of any decision by [*] or any deadline imposed
upon written response by [*] so as to allow [*] to meaningfully review
such decision or written response and also provide comments to [*] in
advance of such decision or deadline to allow comments of [*] respect to
the PATENT RIGHTS to be considered and incorporated into [*] decision or
written response.
6.2 With respect to the filing of any patent application within the PATENT
RIGHTS, or the prosecution of any patent application within the PATENT
RIGHTS, or the maintenance of any patent within the PATENT RIGHTS, if [*]
elects not to file for or continue prosecution of any such patent
application or maintain any such patent,[*] shall promptly notify [*] in
writing sufficiently in advance of any deadline to enable [*] to file for
or continue prosecution of such patent application and/or maintain such
patent, and in such event [*] (or its designee) may at its discretion
pursue such filing, prosecution and/or maintenance of its own expense in
[*] name.
VII. INFRINGEMENT AND DEFENSE
7.1 LICENSEE agrees, itself or through its designee, to use reasonable efforts
generally to enforce the PATENT RIGHTS with respect to substantial
continuing infringements of the PATENT RIGHTS within the LICENSED FIELD,
by initiating legal action, sublicensing the infringing activities or
otherwise. It is understood, however, that such obligation shall not be
deemed to require LICENSEE to take such actions with respect to each such
infringement, and LICENSEE may take into account reasonable strategic and
other considerations in determining which infringers to take action
against, as well as when and whether to do so. If LICENSEE or its designee
commences an action to enforce the PATENT RIGHTS, LICENSEE shall have the
right during the pendency of the action [*]. Any amounts recovered from
third parties by LICENSEE or a SUBLICENSEE with respect to the PATENT
RIGHTS in such action or proceeding shall be applied [*]
7.2 In the event that [*] does not fulfill its obligations under Paragraph 7.1
above,[*] shall have the right to enforce the PATENT RIGHTS relating to
infringement by such a substantial infringer on behalf of [*]; and in such
event [*] shall have the right [*]. Any amounts recovered or received
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from third parties by [*] with respect to the PATENT RIGHTS in such
action, proceeding or license shall be retained by [*].
7.3 In the event that LICENSEE, an AFFILIATE or SUBLICENSEE receives a claim
from a third party alleging an infringement of intellectual property
rights of a third party based upon the manufacture, sale or use of a
LICENSED PRODUCT, LICENSEE shall have the right [*].
7.4 In any suit or dispute involving the enforcement or defense of PATENT
RIGHTS, the parties shall cooperate fully, including without limitation,
subject to the statutory authority of the Attorney General of the State of
Texas as applicable to BOARD and MDA, by joining as a party plaintiff and
executing such documents as the party prosecuting such suit, action or
other proceeding may reasonably request, all at such requesting party's
expense. Upon the request and at the expense of the party bringing suit,
the other party shall make available to the party bringing suit at
reasonable times and under appropriate conditions all relevant personnel,
records, papers, information, samples, specimens, and the like which are
in its possession.
VIII. PATENT MARKING
8.1 LICENSEE agrees that all packaging containing individual LICENSED
PRODUCT(S), and documentation therefor, sold by LICENSEE, AFFILIATES and
SUBLICENSEES of LICENSEE will be marked permanently and legibly with the
number of the applicable patent(s) licensed hereunder in accordance with
each country's patent laws, including Xxxxx 00, Xxxxxx Xxxxxx Code.
IX. INDEMNIFICATION
9.1 LICENSEE shall hold harmless and indemnify BOARD, SYSTEM, MDA, its
Regents, officers, employees, students, and agents from and against any
claims, demand, or causes of action whatsoever, including without
limitation those arising on account of any injury or death of persons or
damage to property, caused by, or arising out of, or resulting from, the
exercise or practice of the license granted hereunder by LICENSEE or its
officers, employees, agents or representatives.
9.2 BOARD shall, to the extent authorized under the Constitution and the laws
of the State of Texas, hold LICENSEE harmless from liability resulting
from the negligent acts or omissions of BOARD or MDA, their agents or
employees pertaining to the activities to be carried out pursuant to the
obligations of this AGREEMENT; provided, however, that BOARD shall not
hold LICENSEE harmless from claims arising out of the negligence of
LICENSEE, its officers, agents or any person or entity not subject to
BOARD's or MDA's supervision or control.
X. USE OF BOARD AND COMPONENTS NAME
10.1 (A) In accordance with BOARD policy, LICENSEE shall not use
the name of BOARD, SYSTEM or BOARD, except as described in
10.1 (B), below.
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(B)(i) LICENSEE may use the name of MDA, BOARD, or SYSTEM only when
indicating, as a factual matter, that MDA, BOARD, or SYSTEM is
a licensor of LICENSEE under this AGREEMENT and only in
connection with either or both of the following:
(a) communications associated with LICENSEE's financing
activities; and
(b) communications (other than promotions and
advertisements) directed to describing or responding to
inquiries concerning the business, technology, products,
services and associated activities of LICENSEE.
(c) in all such communications, LICENSEE shall limit such
use, in substance, to stating that a LICENSED PRODUCT or
other LICENSED SUBJECT MATTER was invented by the
inventor thereof as an employee of MDA and/or that MDA
and/or BOARD is the licensor thereof. In no event shall
LICENSEE use the name of MDA, SYSTEM or BOARD in product
advertising or on product packaging or labels affixed to
any products. Communications in accordance with this
Section 10.1(B) shall not be deemed a breach of Section
6 of either of the RESEARCH AGREEMENTS.
(ii) LICENSEE may otherwise use the name of MDA, BOARD, or SYSTEM
when and as required by applicable law, rules and regulations,
or upon written consent of the party the use of whose name is
requested.
XI. CONFIDENTIAL INFORMATION
11.1 BOARD and LICENSEE each agree that all information contained in documents
marked "confidential" which are forwarded to one by the other shall be
received in strict confidence, used only for the purposes of this
AGREEMENT, and not disclosed by the recipient party (except as required by
law or court order), its agent or employees without the prior written
consent of the other party, unless such information (a) was in the public
domain at the time of disclosure, (b) later became part of the public
domain through no act or omission of the recipient party, its employees,
agents, successors or assigns, (c) was lawfully disclosed to the recipient
party by a third party having the right to disclose it, (d) was already
known by the recipient party at the time of disclosure, (e) was
independently developed or (f) is required to be submitted to a government
agency or as otherwise required by law. Notwithstanding the foregoing or
any provision of the RESEARCH AGREEMENTS, LICENSEE may disclose any
LICENSED SUBJECT MATTER comprising confidential information of BOARD to
third parties pursuant to a reasonable confidentiality agreement, and
otherwise as is reasonably necessary to exploit the LICENSED SUBJECT
MATTER as contemplated in this AGREEMENT.
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11.2 Each party's obligation of confidence hereunder shall be fulfilled by
using at least the same degree of care with the other party's confidential
information as it uses to protect its own confidential information. This
obligation shall exist while this AGREEMENT is in force and for a period
of three (3) years thereafter.
XII. ASSIGNMENT
12.1 This AGREEMENT may not be assigned by LICENSEE without the prior written
consent of BOARD; provided that, at any time after eighteen (18) months
after the Effective Date, LICENSEE may assign this AGREEMENT without such
consent to a party that acquires substantially all of the business or
assets of LICENSEE to which this AGREEMENT pertains, so long as LICENSEE
notifies BOARD and the assignee agrees in writing to be bound by the terms
of this AGREEMENT.
XIII. DUE DILIGENCE
13.1 BOARD shall have a right [*] from the EFFECTIVE DATE to terminate the
exclusivity of the license granted by BOARD to LICENSEE pursuant to
Paragraph 4.1 in any national political jurisdiction within the LICENSED
TERRITORY at any time upon written notice to LICENSEE if LICENSEE fails to
provide written evidence,[*]; provided that termination of such
exclusivity shall not occur unless and until a court of competent
jurisdiction has determined in a suit filed by LICENSEE within [*].
XIV. TERM, TERMINATION, AND DEFAULT
14.1 The term of this AGREEMENT shall extend from the Effective Date set forth
hereinabove to the full end of the term or terms for which PATENT RIGHTS
have not expired and if only TECHNOLOGY RIGHTS are licensed and no PATENT
RIGHTS are applicable, for a term of fifteen (15) years. Notwithstanding
the above, upon the expiration, but not an earlier termination of this
AGREEMENT, LICENSEE shall have a non-exclusive, fully paid-up right and
license under the LICENSED SUBJECT MATTER to use and otherwise exploit the
TECHNOLOGY RIGHTS.
14.2 This AGREEMENT will earlier terminate:
(a) upon the expiration of thirty (30) days written notice from BOARD if
LICENSEE shall become bankrupt and/or if the business of LICENSEE
shall be placed in hand of a receiver, assignee, or trustee, whether
by voluntary act of LICENSEE or otherwise;
(b) (i) [*] written notice from BOARD if LICENSEE shall breach or
default on the payment obligations of Article V, or use of name
obligations of Article X; or (ii) upon [*] written notice if
LICENSEE shall breach or default any other obligation under this
AGREEMENT; provided, however, LICENSEE may avoid such termination if
before the end of the applicable period LICENSEE notifies BOARD that
such breach has been cured
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and states the manner of such cure. However, if LICENSEE disputes
such breach in writing within such [*] period, BOARD shall not have
the right to terminate this AGREEMENT unless and until a court of
competent jurisdiction has determined, in a suit filed by LICENSEE
within [*] period, that this AGREEMENT was materially breached, and
LICENSEE fails to cure such breach within [*] after such
determination;[*].
(c) In its entirety or as to any particular patent application or patent
within the PATENT RIGHTS, upon LICENSEE's sixty (60) days prior
written notice to BOARD. From and after the effective date of a
termination under this Paragraph 15.2(c) with respect to a
particular patent application or patent, such patent application and
patent in the particular country shall cease to be within the PATENT
RIGHTS for all purposes of this AGREEMENT. Upon a termination of
this AGREEMENT in its entirety under this Paragraph 15.2(c), all
rights and obligations of LICENSEE and BOARD shall terminate, except
as provided below.
14.3 Upon termination of this AGREEMENT for any cause, nothing herein shall be
construed to release either party of any obligation matured prior to the
effective date of such termination. LICENSEE may, after the effective date
of such termination, sell all LICENSED PRODUCT and parts therefore that it
may have on hand at the date of termination, provided that it pays earned
royalty thereon as provided in this AGREEMENT.
14.4 Articles IX, X, and XI, shall survive the expiration and any termination
of this AGREEMENT. In addition, upon termination of this AGREEMENT, any
and all existing sublicenses shall survive; provided that such
SUBLICENSEES promptly agree in writing to be bound by the applicable terms
of this AGREEMENT. Except as otherwise provided in this Article XV, all
rights and obligations of the parties under this AGREEMENT shall terminate
upon the expiration or termination of this AGREEMENT.
XV. GENERAL
15.1 This AGREEMENT constitutes the entire and only AGREEMENT between the
parties for LICENSED SUBJECT MATTER and all other prior negotiations,
representations, agreements (including that certain PATENT AND TECHNOLOGY
LICENSE AGREEMENT between the parties hereto executed on April 21, 1994
but not approved by BOARD) and understandings are superseded hereby. No
agreements altering or supplementing the terms hereof may be made except
by means of a written document signed by the duly authorized
representatives of the parties.
-12-
13
15.2 Any notice required by this AGREEMENT shall be given by prepaid, first
class, certified mail, return receipt requested, and addressed in the case
of BOARD to:
BOARD OF REGENTS
The University of Texas System
000 Xxxx Xxxxxxx Xxxxxx
Xxxxxx, Xxxxx 00000
ATTENTION: Office of General Counsel
with a copy to: The University of Texas
M.D. Xxxxxxxx Cancer Center
Office of Technology Development
0000 Xxxxxxxx Xxxxxxxxx, Xxxxx 0000
Xxxxxxx, Xxxxx 00000
ATTENTION: Xxxxxxx X. Xxxx
or in the case of LICENSEE to: Intron Therapeutics, Inc.
000 Xxxxxxxx, Xxxxx 0000
Xxxxxx, Xxxxx 00000
ATTENTION: Mr. Xxxxx Xxxxx
with a copy to: Xxxxxxx X. Xxxxx, Esq.
Wilson, Sonsini, Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
or such other address as may be given from time to time under the terms of
this notice provision.
15.3 LICENSEE shall comply with all applicable federal, state and local laws
and regulations in connection with its activities pursuant to this
AGREEMENT.
15.4 This AGREEMENT shall be construed and enforced in accordance with the laws
of the United States of America and of the State of Texas.
15.5 Failure of BOARD to enforce a right under this AGREEMENT shall not act as
a waiver of that right or the ability to later assert that right relative
to the particular situation involved.
15.6 Headings included herein are for convenience only and shall not be used to
construe this AGREEMENT.
15.7 If any provision of this AGREEMENT shall be found by a court to be void,
invalid or unenforceable, the same shall be reformed to comply with
applicable law or stricken if not so conformable, so as not to affect the
validity or enforceability of this AGREEMENT.
-13-
14
IN WITNESS WHEREOF, parties hereto have caused their duly authorized
representatives to execute this AGREEMENT.
THE UNIVERSITY OF TEXAS BOARD OF REGENTS OF THE
M.D. XXXXXXXX CANCER CENTER UNIVERSITY OF TEXAS SYSTEM
By: /s/ XXXXX X. XXXXXXXX By: /s/ XXXXXX X. XXXXX
--------------------------------- -----------------------------------
Xxxxx X. Xxxxxxxx Xxxxxx X. Xxxxx
Executive Vice President Vice Chancellor for
for Administration and Finance Asset Management
APPROVED AS TO CONTENT: APPROVED AS TO FORM:
By: /s/ XXXXXXX X. XXXX By: /s/ XXXXXX X. XXXXX, XX.
--------------------------------- -----------------------------------
Xxxxxxx X. Xxxx Xxxxxx X. Xxxxx, Xx.
Director, Technology Development Manager, Intellectual Property
INTRON THERAPEUTICS, INC.
By: /s/ XXXXX X. XXXXX
---------------------------------
Xxxxx X. Xxxxx
President
-14-
15
ATTACHMENT A
Patent and technology rights for U.S. and Foreign Patent Application entitled:
[*]
16
EXHIBIT 1
OPTION AGREEMENT
December 15, 1992
Mr. Xxxxx Xxxxx
Managing Partner
Texas Biomedical Development Partners
000 Xxxxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxx, Xxxxx 00000
RE: [*]
Dear Xx. Xxxxx:
In accordance with our recent conversation, I am pleased to inform you that The
University of Texas M.D. Xxxxxxxx Cancer Center (MDA) hereby extends an option
to Texas Biomedical Development Partners (TBDP) to negotiate a license to the
above captioned technology.
This option comprises a promise by MDA not to offer the above-cited technology
to others during a prescribed period of time and a promise to negotiate in good
faith for the grant of a license. It does not in any way constitute a license in
itself. This option is personal to and not assignable by TBDP.
If accepted by your signature below, this option will become active as of
December 10, 1992 and will expire on the latter of June 10, 1994 or within 90
days after completion of the Sponsored Research contemplated herein. If the
notice by TBDP to exercise their option to negotiate a license has not been
received by MDA by June 30, 1994, or 90 days after the completion of the
referenced sponsored research, then MDA will thereafter be free to seek other
prospective licenses for this technology with no further consideration due TBDP.
Should MDA receive written notification from TBDP exercising said option on or
before June 30, 1994, or 90 days subsequent to the completion of the referenced
sponsored research, the parties agree to negotiate a license to the captioned
matter in good faith, consistent with the attached form of agreement (Attachment
A hereto) and consistent with the following terms:
- TBDP will reimburse MDA's patent and other out-of-pocket costs.
- TBDP will pay MDA a running royalty of [*] of licensed products, or [*]
received by TBDP as consideration from any sublicensee, whichever
amount is less.
- TBDP will pay MDA that portion equal to MDA's portion of the running
royalty of any advance royalty or fee received by TBDP from a
sublicensee which is creditable against future running royalties by
the sublicensee.
- TBDP will not be obligated to pay MDA any portion of any advance
payment received by TBDP from a sublicensee which is not creditable
against future running royalties by the sublicensee.
- TBDP will convey individually to Xx. Xxxx X. Xxxx ten percent (10%) of
the capital stock of the new company established by TBDP to complete the
development and commercialization of the captioned matter. Xx. Xxxx'x
share of capital stock in the new company shall not be diluted up to
Initial Public Offering (IPO). However, in the event that the new
company, for example, merges with or is acquired by another entity, or
transfers or sublicenses materially all of its rights under the
contemplated license agreement prior to IPO, then TBDP will convey to
Xx. Xxxx twenty-five percent (25%) of the capital stock of the new
company previously established to develop the captioned matter.
Additionally, if TBDP wishes, at some future date, to syndicate the
development and commercialization of the captioned matter and must give
up equity in the new company, then Xx. Xxxx'x pre-IPO equity position
shall be diluted on a prorate basis with all other capital stockholders.
However, Xx. Xxxx'x share of the capital stock in the new company shall
not be diluted below ten percent (10%) up to IPO.
- TBDP will commit to the development and commercialization of the
captioned matter and will grant MDA a first right of refusal to
conduct the research required for said development and
commercialization.
Should TBDP exercise its option in the time and manner provided herein and
should TBDP and MDA fail to reach agreement on license terms by July 31, 1994,
then MDA will thereafter be free to seek other
17
Mr. Xxxxx Xxxxx EXHIBIT 1
December 15, 1992
Page 2
prospective licensees with no further consideration due TBDP, except MDA agrees
to use reasonable efforts to secure reimbursement of TBDP's direct costs
hereunder from said licensee.
It is agreed between the parties that the consideration for this option is [*]
option fee, plus a commitment of up to [*] for Phase I Clinical Trials and [*]
for basic research (subject to internal approval by MDA, approval by TBDP, and a
definitive Sponsored Research Agreement mutually agreed to and executed by the
parties) on the captioned matter. The [*] option fee, payable upon execution of
this Option Agreement by TBDP, will be applied by MDA as a credit against any
future payments for reimbursement of patent expenses due under a license
agreement subsequently entered into pursuant hereto. The option fee is only
refundable to TBDP in the event that MDA elects not to perform the referenced
research and thereby terminates this Option Agreement. MDA agrees to notify TBDP
of MDA's intention, if any, to terminate this Option Agreement within a
reasonable period of time.
If the provisions of this Option Agreement are satisfactory to you, then please
indicate your acceptance of these terms by signing and returning the enclosed
copy of this letter.
Very truly yours,
/s/ XXXXXXX X. XXXX
--------------------------------------
Xxxxxxx X. Xxxx
Director, Technology Development
WJD:ipm
cc: Xxxx X. Xxxx, M.D.
Tapas Mukhopadhyay, Ph.D.
Xxxxxxx X. Xxxxxxx, Ph.D.
AGREED TO BY TEXAS BIOMEDICAL DEVELOPMENT PARTNERS
By: /s/ XXXXX XXXXX
------------------------------------
Xxxxx Xxxxx
Managing Partner
Date: 12-17-92
-2-
18
EXHIBIT 2
June 17, 1993
Xx. Xxxxxxx X. Xxxx
Director
Technology Development
The University of Texas
M.D. Xxxxxxxx Cancer Center
0000 Xxxxxxxx Xxxxxxxxx
Xxxxxxx, XX 00000
FAX (000) 000-0000
Re: [ * ] and Option Agreement for "Methods and Compositions for
Retroviral Vector Mediated Transduction", Xxxx X. Xxxx,
M.D., et al., dated December 15, 1992.
Dear Xxxx:
This is to inform you that Texas Biomedical Development Partners (TBDP)
wishes to exercise the above referenced options and to immediately begin
preparation of a License Agreements as contemplated in the Option Agreements.
Further, TBDP wishes to assign its rights and responsibilities under the
respective Option Agreements and under the prospective License Agreements to new
corporations established to commercialize the technologies optioned and/or
supported by Sponsored Research Agreements with TBDP.
Respecting the technologies and research associated with the laboratory of
[*]
Respecting the technologies and research associated with the laboratory of
Xx. Xxxx, the new company is Intron Therapeutics Inc., a Delaware Corporation .
If you have any questions please do not hesitate to call.
I look forward to working with you to document and expedite the License
Agreements.
Yours very truly,
/s/ XXXXX XXXXX
--------------------------------------
Xxxxx Xxxxx
Managing Partner
19
EXHIBIT 3
[SR 93-04 SPONSORED
RESEARCH AGREEMENT]
20
EXHIBIT 4
[CS 93-27 SPONSORED RESEARCH
AGREEMENT FOR CLINICAL STUDY]
21
EXHIBIT 5
November 26, 1993
Xx. Xxxxxxx X. Best
Chief Financial officer
The University of Texas
M.D. Xxxxxxxx Cancer Center
0000 Xxxxxxxx Xxxxxxxxx
Xxxxxxx, XX 00000
RE: Sponsored Research Agreement (SR93-04), "Development of Therapeutic
Treatment and Prevention of Lung Cancer", and Sponsored Research Agreement
(CS93-27), "Clinical Protocol for Modification of Oncogene and Tumor
Suppressor Gene Expression in Non-Small Cell Lung Cancer (NSCLC)".
Dear Mr. Best:
Pursuant to Article 11 of the above referenced sponsored research agreements,
Texas Biomedical Development Partners herewith provides notification that it has
assigned substantially all of its business respecting the subject sponsored
research agreements to Intron Therapeutics, Inc.
Please contact me if you have any questions.
Sincerely,
/s/ XXXXX XXXXX
-------------------
Xxxxx Xxxxx
Managing Partner
cc: Xxxx X. Xxxx, M.D.
Xxxxxxx X. Xxxx
Xxxxx X. Xxxxxxx, CPA
22
AMENDMENT NO. 1
TO THE
PATENT AND TECHNOLOGY LICENSE AGREEMENT
This is AMENDMENT NO. 1 effective this 1st day of September, 1996,
("EFFECTIVE AMENDMENT NO. 1 DATE") to the patent and Technology License
Agreement dated July 20, 1994 (hereinafter referred to as the "AGREEMENT"), by
and between THE UNIVERSITY OF TEXAS M.D. XXXXXXXX CANCER CENTER (hereinafter
referred to as "MDA"), located at Houston, Texas, and which is a component
institution of THE UNIVERSITY OF TEXAS SYSTEM (hereinafter referred to as
"SYSTEM") which is governed by a BOARD OF REGENTS (hereinafter referred to as
"BOARD") and INTROGEN THERAPEUTICS, INC., located at 000 Xxxxxxxx Xxxxxx, Xxxxx
0000, Xxxxxx, Xxxxx 00000 (hereinafter referred to as "LICENSEE").
RECITALS
A. BOARD is the owner of the PATENT AND TECHNOLOGY RIGHTS of the
invention(s) listed in ATTACHMENT A hereto ("INVENTIONS(s)").
B. LICENSEE is a company interested in the development and
commercialization of new technologies directed to the treatment of
cancer, and other threatening diseases, to which end LICENSEE, MDA and
BOARD entered into the AGREEMENT noted hereinabove.
C. LICENSEE wishes to add the INVENTION(s) to its rights and obligations
under the AGREEMENT.
D. BOARD wishes to grant LICENSEE rights to the INVENTION(s) under the
AGREEMENT to promote its practical development for the benefit of the
MDA's patients and for the benefit of the people of the state of Texas.
E. The definitions set forth in the AGREEMENT shall apply in this
AMENDMENT NO. 1, except to the extent that a definition herein is
specific to this AMENDMENT NO. 1.
NOW, THEREFORE, in consideration for the mutual covenants contained herein, the
sufficiency of which is hereby acknowledged, the parties hereby agree to the
following:
-1-
23
AMENDED TERMS
1. Attachment A to the AGREEMENT is hereby amended by adding to the
LICENSED SUBJECT MATTER thereof the INVENTION(s) listed in Schedule A
of this Amendment.
2. In addition to the reimbursements for patent expenses provided for
under the AGREEMENT and all other amendments thereto, LICENSEE shall
reimburse MDA [*] of the EFFECTIVE DATE of this AMENDMENT NO. 1 for [*]
related to the INVENTION(s) and shall further reimburse MDA for [*] for
the INVENTION(s) pursuant to Article 4.1(a) of the AGREEMENT [*],
pursuant to invoicing by MDA.
OTHERWISE, the terms and provisions of the original AGREEMENT thereto
shall remain in full force and effect, provided, however, that in the event of a
conflict in the terms and conditions between this AMENDMENT NO. 1 and the
AGREEMENT, the terms and conditions of the AGREEMENT shall prevail.
IN WITNESS WHEREOF, THE PARTIES HERETO HAVE CAUSED THEIR DULY
AUTHORIZED REPRESENTATIVES TO EXECUTE THIS AMENDMENT NO. 1.
THE UNIVERSITY OF TEXAS BOARD OF REGENTS OF THE
M.D. XXXXXXXX CANCER CENTER UNIVERSITY OF TEXAS SYSTEM
By: /s/ XXXXX X. XXXXXXXX By: /s/ XXXXXXX X. XXXXXXX
------------------------------------ ----------------------------------
Xxxxx X. Xxxxxxxx Xxxxxxx X. Xxxxxxx, M.D.
Executive Vice President Chancellor
for Administration and Finance
APPROVED AS TO CONTENT APPROVED AS TO FORM
By: /s/ XXXXXXX X. XXXX By: /s/ XXXXXX X. XXXXX, XX.
------------------------------------ ----------------------------------
Xxxxxxx X. Xxxx Xxxxxx X. Xxxxx, Xx.
Director, Technology Development Manager, Intellectual Property
INTROGEN THERAPEUTICS, INC.
By: /s/ XXXXX X. XXXXX
-----------------------------------
Xxxxx X. Xxxxx
President
-2-
24
SCHEDULE A
Patent and Technology rights for U.S. and Foreign Patent Application entitled:
[*]
-3-
