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Exhibit 10.11
SR 93-04
SPONSORED RESEARCH AGREEMENT
Agreement, made this 11th day of February, 1993, by and by and between
THE UNIVERSITY OF TEXAS M.D. XXXXXXXX CANCER CENTER (hereinafter referred to as
"CANCER CENTER"), a component institution of The University of Texas System
(hereinafter referred to as "SYSTEM"), located in Houston, Texas, and Texas
Biomedical Development Partners (hereinafter referred to as "SPONSOR"), located
in Austin, Texas.
WITNESSETH:
WHEREAS, CANCER CENTER has research facilities and situations which
would allow investigation and study of the "Development of Therapeutic Treatment
and Prevention of Lung Cancer" an described in Exhibit I hereinafter referred to
as ("Research"), a copy of which in attached hereto and incorporated herein by
reference; and
WHEREAS, both SPONSOR and CANCER CENTER consider it necessary and
desirable to perform the Research;
NOW, THEREFORE , the parties agree as follows:
1. Evaluation. SPONSOR agrees to engage the services of CANCER CENTER
as an independent contractor to perform the Research. The Research will be under
the supervision of Xxxx X. Xxxx, M.D. (Principal Investigator) at CANCER CENTER,
with the assistance of appropriate associates and colleagues at CANCER CENTER as
may be required.
2. Research. CANCER CENTER agrees as an independent contractor to
conduct the Research. Such Research was originally approved by CANCER CENTER in
accordance with CANCER CENTER policy and may be subsequently amended only in
accordance with CANCER CENTER policy and the written agreement of CANCER CENTER
and SPONSOR as provided for in Article 15 herein below.
3. Invention and Patents.
a. For all purposes herein, "Invention" shall mean any
discovery, concept or idea whether or not patentable or copyrightable, which (i)
arises out of work performed pursuant to the obligations of this Agreement; (ii)
is conceived and reduced to practice during the term of the Agreement as defined
in Article 13 herein below; and (iii) includes but is not limited to processes,
methods, software, formula, techniques, compositions of matter, devices, and
improvements thereof and know-how relating thereto. Inventions made solely by
the Principal investigator and/or other CANCER CENTER personnel
as identified in Article I hereinabove or agents of CANCER CENTER shall be the
sole property of CANCER CENTER.
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b. In the event that an invention is made, CANCER CENTER
agrees to include such invention in the option Agreement of December 17, 1992
(attached hereto as Exhibit II) previously entered into by CANCER CENTER and
SPONSOR and give notice of such Invention to SPONSOR within thirty (30) days of
the identification of such Invention.
4. Confidentiality. In the course of work performed pursuant to the
Research under this Agreement, should either party provide confidential
information to the other party, the recipient party shall, until three (3) years
after the termination of this Agreement, maintain the confidentiality of that
information as it maintains the confidentiality of its own confidential
information, and shall not disclose such confidential information to any other
party, nor shall the recipient party disclose the disclosing party's
confidential information to the recipient's employees other than those employees
having a "need-to-know". Confidential information shall be clearly marked as
such. If disclosed orally, the party making the disclosure shall be responsible
for clearly informing the recipient party of the confidentiality of the
information disclosed. Notwithstanding the other provisions of this paragraph,
nothing disclosed hereunder shall be construed as confidential information
which:
a. is or becomes available to the public (except by a breach
of this Agreement by a party hereto);
b. is rightfully received from another party not under
obligation of confidentiality to the disclosing party;
c. is not known by the recipient party, or is independently
developed by the recipient party by persons without access to the confidential
information;
d. is approved for release by the party designating the
information an confidential;
e. is not identified as confidential at the time of
disclosure;
f. is not in writing or physical form at time of disclosure or
reduced to a written or physical form and identified as confidential within
thirty (30) days of disclosure; or
g. is required to be disclosed under the laws of the United
States of America or the State of Texas or other governmental bodies, provided
that the parties shall first exhaust all reasonable measures available to
protect the confidentiality of such information upon disclosure.
5. Publication Rights. Notwithstanding the provisions of Article 4 of
this Agreement, CANCER CENTER may publish scientific papers relating to the
collaborative research performed under this Agreement. In the event that CANCER
CENTER wishes to publish, CANCER CENTER shall notify SPONSOR of its desire to
publish [*] in advance of publication and shall furnish to SPONSOR a written
description of the subject matter of the publication in order to permit SPONSOR
to review and comment thereon.
[*] 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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6. Publicity. CANCER CENTER acknowledges SPONSOR's intention to
distribute periodically informational releases and announcements to the news
media regarding the progress of research hereunder. SPONSOR shall not release
such materials containing the name of CANCER CENTER or any of its employees
without prior written approval by an authorized representative of CANCER CENTER,
and said approval shall not be unreasonably withheld. Should CANCER CENTER
reject the news release, CANCER CENTER and SPONSOR agree to discuss the reasons
for CANCER CENTER's rejection, and every effort shall be made to develop an
appropriate informational news release within the bounds of accepted academic
practices. SPONSOR reserves the same right in the event that CANCER CENTER
desires to distribute a news release concerning the research program. Nothing
herein shall be construed as prohibiting CANCER CENTER or SPONSOR from reporting
on this study to a governmental agency.
7. Responsibility. The parties each agree to assume individual
responsibility for the actions and omissions of their respective employees,
agents and assigns in conjunction with this evaluation.
8. Independent Contractor. SPONSOR will not have the right to direct or
control the activities of CANCER CENTER in performing the services provided
herein, and CANCER CENTER shall perform services hereunder only as an
independent contractor, and nothing herein contained shall be construed to be
inconsistent with this relationship or status. Under no circumstances shall
CANCER CENTER be considered to be an employee or agent of SPONSOR. This
Agreement shall not constitute, create or in any way be interpreted as a joint
venture, partnership or formal business organization of any kind.
9. Title to Equipment. CANCER CENTER shall retain title to all
equipment purchased and/or fabricated by it with funds provided by SPONSOR under
this Agreement.
10. Survivorship. The provisions of Article 3, 4, 5, 6, and 12 shall
survive any expiration or termination of this Agreement.
11. Assignment. This Agreement may not be assigned by either party
without the prior written consent of the other party; provided, however, that
SPONSOR may assign this Agreement to any purchaser or transferee of all or
substantially all of SPONSOR's business upon prior written notice to CANCER
CENTER.
12. Indemnification. CANCER CENTER shall, to the extent authorized
under the Constitution and the laws of the State of Texas, hold SPONSOR harmless
from liability resulting from the negligent acts or omissions of CANCER CENTER,
its agents or employees pertaining to the activities to be carried out pursuant
to the obligations of this Agreement; provided, however, that CANCER CENTER
shall not hold SPONSOR harmless from claims arising out of the negligence of
SPONSOR, its officers, agents or any person or entity not subject to CANCER
CENTER supervision or control.
SPONSOR shall indemnify and hold harmless SYSTEM, CANCER CENTER, their
regents, officers, agents and employees from any liability or loss resulting
from judgments or claims against them arising out of the activities to be
carried out pursuant to the obligations of this Agreement or the use by
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SPONSOR of the results of the Research, provided, however, that the following is
excluded from SPONSOR's obligation to indemnify and hold harmless:
a. the negligent failure of CANCER CENTER to comply with
any applicable governmental requirements; or
b. the negligence or willful malfeasance by a regent,
officer, agent or employee of CANCER CENTER or
SYSTEM.
13. Award. SPONSOR agrees to pay CANCER CENTER a fee of [*]. This fee,
as shown [*] in Exhibit 1, which is attached hereto and is incorporated herein
by reference, for information only, shall be payable [*].
14. Basic Term. This Agreement shall become effective as of the date
first herein above written and unless earlier terminated as hereinafter
provided, shall continue in force for a period of Eighteen (18) months after the
same.
15. Default and Termination. In the event that either party to this
Agreement shall be in default of any of its material obligations hereunder and
shall fail to remedy such default within [*] after receipt of written notice
thereof, the party not in default shall have the option of terminating this
Agreement by giving written notice thereof, notwithstanding anything to the
contrary contained in this Agreement. Termination of this Agreement shall not
affect the rights and obligations of the parties which accrued prior to the
effective date of termination. SPONSOR shall pay CANCER CENTER for all
reasonable expenses Incurred or committed to be expanded as of the effective
termination date, subject to the maximum amount as specified in Article 13.
16. Entire Agreement. The parties acknowledge that this Agreement and
the attached Exhibits hereto represent the sole and entire Agreement between the
parties hereto pertaining to the Research and that such supersedes all prior
Agreements, understandings, negotiations and discussions between the parties
regarding same, whether oral or written. There are no warranties,
representations or other Agreements between the parties in connection with the
subject matter hereof except as specifically set forth herein. No supplement,
amendment, alteration, modification, waiver or termination of this Agreement
shall be binding unless executed in writing by the parties hereto.
17. Reform of Agreement. If any provision of this Agreement is, or in
doomed invalid, illegal or unenforceable in any United States jurisdiction, such
provision shall be deemed amended to conform to applicable laws so as to be
valid and enforceable; or if it cannot be so amended without materially altering
the Intention of the parties, it shall be stricken, and the remainder of this
Agreement shall remain in full force and affect.
[*] 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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18. Default and Termination. Any notices, statements, payments, or
reports by this Agreement shall be considered given if sent by United States
Certified Mail, postage prepaid and addressed as follows:
If to CANCER CENTER:
Xxxxxxx X. Sent
Chief Financial officer
The University of Texas M.D. Xxxxxxxx Cancer Center 0000 Xxxxxxxx Xxxx.
Xxxxxxx, Xxxxx 00000
If to SPONSOR
Xxxxx Xxxxx
Managing Partner
Texas Biomedical Development Partners
000 Xxxxxxxx Xxxxxx, Xxxxx 000 Xxxxxx, Xxxxx 00000
19. Caption. The captions in this Agreement are for convenience only
and shall not be considered a part of or affect the construction or
interpretation of any provision of this Agreement.
20. Governing Law. This Agreement shall be governed and interpreted in
accordance with the substantive laws of the State of Texas and with applicable
laws of the United States of America.
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IN WITNESS WHEREOF, CANCER CENTER and SPONSOR entered into this
Agreement effective as of the date first herein above written and have executed
three (3) originals each of which are of equal dignity.
TEXAS BIOMEDICAL DEVELOPMENT THE UNIVERSITY TEXAS
PARTNERS M.D. XXXXXXXX CANCER CENTER
By:/s/ XXXXX XXXXX By:/s/XXXXXXX X. BEST
--------------------------------------- ------------------------------
Xxxxx Xxxxx Xxxxxxx X. Best
Managing Partner Chief Financial Officer
I have read this agreement and
understanding my obligations hereunder: CONTENT APPROVED:
By:/s/ XXXX X. XXXX By:/s/ XXXXX X. XXXXXXX
--------------------------------------- ------------------------------
Xxxx X. Xxxx, M.D. Xxxxx X. Xxxxxxx, CPA
Principal Investor Manager, Sponsored Agreements
FORM APPROVED:
By:/s/ XXXXXXX X. XXXXX By:/s/ XXXXXXX X. XXXX
--------------------------------------- ------------------------------
Xxxxxxx X. Xxxxx, M.D. Xxxxxxx X. Xxxx, X.X.
Head, Division of Surgery Legal Services Officer
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EXHIBIT I
[*]
[*] 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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AMENDMENT NO. 1
TO
RESEARCH AGREEMENT
This Amendment No. 1 to Research Agreement ("AMENDMENT") is made and
entered into as of July 20, 1994 by and between INTRON THERAPEUTICS, INC., a
Delaware Corporation ("SPONSOR") and THE UNIVERSITY OF TEXAS M.D. XXXXXXXX
CANCER CENTER ("CANCER CENTER"), a component institution of the University of
Texas System ("SYSTEM").
RECITALS
A. SPONSOR and CANCER CENTER entered into a SPONSORED RESEARCH
AGREEMENT, number SR 93-04, dated as of February 11, 1993 (the "RESEARCH
AGREEMENT").
B. SPONSOR, CANCER CENTER and the Regents of the University of Texas
System have entered into a PATENT AND TECHNOLOGY LICENSE AGREEMENT dated as of
July 20, 1994 (the "LICENSE AGREEMENT").
C. CANCER CENTER and SPONSOR wish to extend the term of the RESEARCH
AGREEMENT, acknowledge that the RESEARCH to be conducted thereunder will include
matters beyond the study outline attached to the RESEARCH AGREEMENT as
originally executed, and that SPONSOR will have the option to include within the
LICENSED SUBJECT MATTER under the LICENSE AGREEMENT any intellectual property
that is made in the course of performing under the RESEARCH.
NOW, THEREFORE, it is hereby agreed as follows:
21. DEFINITIONS. Any capitalized terms that are not otherwise
defined herein shall be defined in the RESEARCH AGREEMENT or the LICENSE
AGREEMENT. In addition, for all purposes of the RESEARCH AGREEMENT, the term
"RESEARCH" shall be deemed to include all work of CANCER CENTER personnel in
performing the study described in Exhibit I to RESEARCH AGREEMENT as originally
executed and as modified from time to time, as well as any work that is
performed by Xx. Xxxx X. Xxxx or other CANCER CENTER personnel comprising
additional research projects described in Attachment A-n, where n represents the
ordinal number of a particular project.
22. Invention and Patents. Section 3 of the RESEARCH AGREEMENT
shall be amended as follows:
(a) So much of Section 3(a) of the RESEARCH AGREEMENT
as reads "(i) arises out of work performed pursuant to the obligations of this
AGREEMENT' is hereby amended to read "(i) arises out of the Research;"
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(b) Paragraph (b) of Section 3 is hereby deleted and
replaced in its entirety with the following:
"b. In the event that an Invention is made, CANCER CENTER
shall notify SPONSOR, which notice shall reference
this Section 3 and include a description of the
Invention in reasonable detail. SPONSOR shall have
the option to include all worldwide patent rights
with respect to such Invention within the "EXISTING
PATENT RIGHTS" under Section 2.3(a) of the LICENSE
AGREEMENT,' and to include related information,
know-how, biological materials and the like within
the TECHNOLOGY RIGHTS under the LICENSE AGREEMENT. To
exercise such option with respect to any particular
Invention, SPONSOR shall so notify CANCER CENTER
within 120 days after receipt of CANCER CENTER's
notice thereof as described above. Promptly following
such exercise, the parties shall revise Schedule A to
the LICENSE AGREEMENT to reflect the additional paten
applications so included. CANCER CENTER warrants to
SPONSOR that CANCER CENTER has the right to grant to
SPONSOR the option and rights contemplated in this
Section 3 and that upon exercise of the option
described herein with respect to any Invention, all
worldwide patent rights therein will be included
under the LICENSE AGREEMENT.'
23. Term. Section 14 of the RESEARCH AGREEMENT is hereby
amended by adding to the end thereof the following: "Following such initial
Eighteen (18) month period, unless earlier terminated as provided in Section 15,
this Agreement shall continue in full force and effect until terminated by
either parry for any reason on ninety (90) days prior written notice to the
other party."
24. Other. Except as expressly provided in this AMENDMENT, all
other terms, conditions and provisions of the RESEARCH AGREEMENT shall continue
in effect as provided therein.
IN WITNESS WHEREOF, CANCER CENTER and SPONSOR entered into this
AMENDMENT effective as of the date first hereinabove written and have executed
(3) originals each of which are of equal dignity.
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IN WITNESS WHEREOF, each of the parties has executed this Amendment as
of the date first above written.
TEXAS BIOMEDICAL DEVELOPMENT THE UNIVERSITY OF TEXAS
PARTNERS M.D. XXXXXXXX CANCER CENTER
By:/s/ XXXXX XXXXX By:/s/ XXXXXXX X. BEST
----------------------------------- -------------------------
Xxxxx Xxxxx Xxxxxxx X. Best
Managing Partner Chief Financial Officer
I have read this agreement and
understand my obligations
hereunder: CONTENT APPROVED:
By:/s/ XXXX X. XXXX By:/s/ XXXXX X. XXXXXXX
----------------------------------- -------------------------
Xxxx X. Xxxx, M.D. Xxxxx X. Xxxxxxx, CPA
Principal Investor Manager, Sponsored
Agreements
FORM APPROVED:
By:/s/ XXXXXXX GOEFERT By:NOT APPLICABLE
----------------------------------- -------------------------
Xxxxxxx Goefert, M.D. Xxxxxxx X. Xxxx, X.X.
Head, Division of Legal Services Officer
Surgery and Anesthesiology
(Ad interim)
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AMENDMENT NO. 2
TO
SPONSORED RESEARCH AGREEMENT
STATE OF TEXAS
COUNTY OF XXXXXX
AMENDMENT, effective this lst day of January, 1995, between THE
UNIVERSITY OF TEXAS M.D. XXXXXXXX CANCER CENTER (hereinafter referred to as
"CANCER CENTER"), a component of THE UNIVERSITY OF TEXAS SYSTEM (hereinafter
referred to as "SYSTEM") located at Houston, Texas, and INTROGEN THERAPEUTICS,
formerly Intron Therapeutics, Inc. ((hereinafter referred to as "SPONSOR"), of
the Sponsored Research Agreement made by these parties and dated the 11th day of
February, 1993 and amended the 20th day of July, 199_, regarding research on the
evaluation and study of the "Development of Therapeutic Treatrnent and
Prevention of Lung Cancer".
1. CANCER CENTER and SPONSOR agree that the period of work
identified the original Sponsored Research Agreement shall be
extended to the latter of February 29, 1996 or the completion
of the project.
2. CANCER CENTER and SPONSOR agree that the work to be done
during this extended work period will be performed according
to the procedures described in the revised workscope, the
title of which is "Development of Gene Therapeutic Treatment
and Prevention for Cancer", a copy of which is attached hereto
as Exhibit I and incorporated herein by reference. The
workscope has been amended and approved in accordance with
institutional policy. The sponsored research agreement may be
extended by the Sponsor upon notification to CANCER CENTER and
Investigator to provide CANCER CENTER and Investigator with
the funds needed to complete the research provided the
research is within the workscope as herein described.
3. CANCER CENTER and SPONSOR agree that the specific additional
costs associated with this work shall be [*].
4. CANCER CENTER acknowledges that [*].
OTHERWISE, the terms and provisions of the original Agreement executed
on the 11th of February, 1993 and amended on the 20th day of July, 1994 by and
between the parties shall in full force and effect, provided, however, that in
the event of a conflict in the terms and conditions between this Amendment No. 2
and the Sponsored Research Agreement, the terms and conditions of this Amendment
shall prevail.
[*] 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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IN WITNESS WHEREOF, the parties have executed two (2) original
counterparts of this Amendment No. 2, each of which are of equal dignity and
effective a of the date first hereinabove written.
SPONSOR THE UNIVERSITY OF TEXAS SYSTEM
M.D. XXXXXXXX CANCER CENTER
BY:/s/ XXXXX XXXXX BY:/s/ XXXXXXX X. BEST
----------------------------------- --------------------------------------
Xxxxx Xxxxx Xxxxxxx X. Best
President Chief Financial Officer
Introgen Therapeutics, Inc.
I have read this amendment and understand
my obligations hereunder:
BY:/s/ XXXX X. XXXX
--------------------------------------
Xxxx X. Xxxx, M.D.
Principal Investigator
BY:/s/ XXXXXXX XXXXXXXX
--------------------------------------
Xxxxxxx Xxxxxxxx, M.D.
Ad Interim Head, Div. of Surgery
CONTENT APPROVED:
BY:/s/ XXXXX X. XXXXXXX
--------------------------------------
Xxxxx X. Xxxxxxx, CPA
Manager, Sponsored Programs
Payment Mailing Address:
The University of Texas
M.D. Xxxxxxxx Cancer Center
Attention: Manager, Sponsored Programs
X.X. Xxx 000000
Xxxxxxx, Xxxxx 00000
Tax ID: 74-6001118-A1
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EXHIBIT I
[*]
[*] 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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AMENDMENT NO. 3
TO
SPONSORED RESEARCH AGREEMENT
AMENDMENT, effective this 31st day of December, 1995, between THE
UNIVERSITY OF TEXAS M.D. XXXXXXXX CANCER CENTER (hereinafter referred to as
"CANCER CENTER"), a component of THE UNIVERSITY OF TEXAS SYSTEM (hereinafter
referred to as "SYSTEM") located at Houston, Texas, and INTROGEN THERAPEUTICS
(hereinafter referred to as "SPONSOR"), of the Sponsored Research Agreement made
by these parties and dated the 11th day of February, 1993 and subsequently
amended, regarding research on the evaluation and study of the "Development of
Therapeutic Treatment and Prevention of Lung Cancer".
1. CANCER CENTER and SPONSOR agree that the period of work
identified in the Original Sponsored Research Agreement shall
be extended to December 31, 1996.
2. CANCER CENTER and SPONSOR agree that the work to be done
during this extended work period will be performed according
to the procedures described in the revised workscope, the
title of which is "Development of Gene Therapeutic Treatment
and Prevention for Cancer", a copy of which is attached hereto
as Exhibit I and incorporated herein by reference. The
workscope has been amended and approved in accordance with
institutional Policy.
3. CANCER CENTER and SPONSOR agree that the specific additional
costs associated with this work shall be [*].
4. CANCER CENTER and SPONSOR agree that the fee of [*].
5. Access to Information. All results of and information arising
from the Research shall be made available and accessible to
SPONSOR by CANCER CENTER. SPONSOR shall have the right to
obtain copies or duplicates of such results and information on
a timely basis, in either written or electronic form, upon
SPONSOR giving CANCER CENTER reasonable notice of SPONSOR"s
desire to obtain such results and information.
OTHERWISE, the terms and provisions of the original Agreement executed
on the 11th day of February, 1993 and subsequently amended by and between the
parties hereto 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. 3
and the Sponsored Research Agreement the terms and conditions of this Amendment
shall prevail.
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IN WITNESS WHEREOF, the parties have executed two (2) original
counterparts of this Amendment No. 3, each of which are of equal dignity and
effective as of the date first hereinabove written.
INTROGEN THERAPEUTICS, INC. THE UNIVERSITY OF TEXAS
M.D. XXXXXXXX CANCER CENTER
BY:/s/ XXXXX XXXXX BY:/s/ XXXXXXX X. BEST
------------------------------- ---------------------------------
Xxxxx Xxxxx Xxxxxxx X. Best
President Chief Financial Officer
Introgen Therapeutics, Inc.
I have read this
amendment and
understand my
obligations hereunder:
BY:/s/ XXXX X. XXXX
---------------------------------
Xxxx X. Xxxx, M.D.
Principal Investigator
BY:/s/ XXXXXXX XXXXXXXX
---------------------------------
Xxxxxxx Xxxxxxxx, M.D.
Ad Interim Head, Div. of Surgery
PAYMENT MAILING ADDRESS:
The University of Texas
M.D. Xxxxxxxx Cancer Center
Atten: Manager, Sponsored Programs
X.X. Xxx 000000
Xxxxxxx, Xxxxx 00000
Tax ID: 74-6001118-Al
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EXHIBIT I
[*]
[*] 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.
