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Exhibit 10.10
SR 95-012
Agreement, made this 21th day of September, 1995, 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 Introgen
Therapeutics (hereinafter referred to as "SPONSOR"), located in Austin, Texas.
WITNESSETH:
WHEREAS, SPONSOR is the licensee of the Adenovirus Vector Expression
Wild-Type p53 which has potential utilization in patient care and treatment; and
WHEREAS, CANCER CENTER has research facilities and situations which
would allow clinical investigation and study of the "Modification of Tumor
Suppressor Gene Expression in Head and Neck Squamous Cell Carcinoma (HSCC) with
an Adenovirus Vector Expression Wild-Type p53" as described in Exhibit I
hereinafter referred to as ("Research"), a copy of which is attached hereto and
incorporated herein by reference; and
WHEREAS, both SPONSOR and CANCER CENTER consider it necessary and
desirable 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. Xxxxxxx, 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 16 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 14 hereinbelow; and (iii) includes but is not limited to processes,
methods, software, formulae, 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 1 hereinabove or agents of CANCER CENTER shall be the sole property of
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CANCER CENTER. Inventions made jointly by employees or agents of CANCER CENTER
and SPONSOR shall be jointly owned by CANCER CENTER and SPONSOR.
b. In the event that an Invention is made, either solely by employees
ro agents of CANCER CENTER or jointly by employees or agents of CANCER CENTER
and SPONSOR, CANCER CENTER and SPONSOR agree to give notice of such Invention to
each other within thirty (30) days of the identification of such Invention.
Within thirty (30) days of notice of Invention, CANCER CENTER and SPONSOR will
thereupon exert their best reasonable efforts in cooperation with each other to
investigate, evaluate and determine to the mutual satisfaction of both parties,
the disposition of rights to the Invention, including whether, by whom, and
where any patent applications are to be filed.
c. If, after consultation with SPONSOR, it is agreed by the parties
that a patent application should be filed, CANCER CENTER will prepare and file
appropriate United States and foreign patent applications on Inventions made
under this Agreement, and SPONSOR will pay the cost of preparing, filing and
maintenance thereof. If SPONSOR notified CANCER CENTER that it does not intend
to pay the costs of an application, or if SPONSOR does not respond or make an
effort to agree with CANCER CENTER on the disposition of rights to the
INVENTION, THEN cancer center MAY FILE SUCH APPLICATION AT ITS OWN EXPENSE, AND
sponsor shall have no rights to such Invention. CANCER CENTER will provide
SPONSOR a copy of the application filed for which SPONSOR has paid the cost of
filing, as well as copies of any documents received or filed during prosecution
thereof. SPONSOR agrees to maintain any such application in confidence until it
is published by CANCER CENTER or by the respective patent office.
d. Under the terms the "Patent and Technology License Agreement between
CANCER CENTER and Introgen (Intron) Therapeutics" dated effective July 20, 1994,
CANCER CENTER hereby licenses to SPONSOR an exclusive, world-wide,
royalty-bearing license to invention (as well as patent applications, patents,
and copyrights thereon) for commercial purposes, provided that SPONSOR shall pay
all costs and expenses associated with patent and copyright filing, prosecution,
issuance, and maintenance. SPONSOR shall have thirty (30) days from written
notice of Invention from CANCER CENTER pursuant to Article 3(b) hereinabove, to
give written notice to CANCER CENTER to include any invention in the above
referenced licensed agreement.
4. Confidentiality. Because CANCER CENTER and SPONSOR will be cooperating with
each other in this Research, and because each may reveal to the other in the
course of this Research certain confidential information, CANCER CENTER and
SPONSOR agree to hold any confidential information which (a) is obtained during
the course of this work and (b) is related thereto and (c) is marked as
"CONFIDENTIAL" in confidence, and each party will not disclose same to any third
party without the express written consent of the other party to this Agreement.
This requirement shall remain in force for a period of three (3) years following
completion of work under this Agreement. Nothing in this paragraph shall in any
way restrict the rights of either CANCER CENTER or SPONSOR to use, disclose or
otherwise deal with any information which:
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a. can be demonstrated to have been in public domain as of the
effective date of this Agreement or comes into the public domain through the
term of this Agreement through no act of the recipient; or
b. can be demonstrated to have been known to the recipient prior to the
execution of this Agreement; or
c. can be demonstrated to have been rightfully received by the
recipient after disclosure under this Agreement from a third party who did not
require the recipient to hold it in confidence or limit its use and who did not
acquire it, directly or indirectly, under obligation of confidentiality to the
disclosing party; or
d. shall be required for disclosure to Federal regulatory agencies
pursuant to approval for use; or
e. is independently invented by researchers of the recipient, which in
the case of CANCER CENTER includes SYSTEM, who have not had access to the
information provided to the recipient hereunder.
Nothing herein is intended to give SPONSOR the right to use for any purpose
pre-existing confidential information of CANCER CENTER. Notwithstanding the
confidentiality obligations of this Agreement, nothing herein shall prevent
CANCER CENTER and any other component of SYSTEM from using any information
generated hereunder for ordinary research and educational purposes of a
university.
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.
6. Publicity. CANCER CENTER acknowledges SPONSOR'S intention to distribute
periodically information 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 employee, agents and assigns
in conjunction with this evaluation.
[*] 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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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 Articles 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's
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 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 equal to [ * ]. This fee,
as shown [ * ] in Exhibit II, which is attached hereto and is incorporated
herein by reference, for information only, shall be paid by Sponsor at such
times and in such amounts as mutually agreed upon between Sponsor and Cancer
Center, but at a minimum in the following amounts on the following dates:
[ * ]
[*] 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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14. Basic Term. This Agreement shall become effective as of the date first
hereinabove written and unless earlier terminated as hereinafter provided, shall
continue in force for a period of Five (5) years after the same.
15. Default and Termination. In the event that the patient enrollment and
treatment is completed earlier than estimated, SPONSOR may terminate the
agreement provided that all costs and fees as herein agreed have been paid by
SPONSOR. In the event that FDA or NIH or other governing regulatory agency
requests the clinical study herein contemplated be halted or suspended, then
SPONSOR and CANCER CENTER agree to terminate this Agreement
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, becomes or is
deemed 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 effect.
18. Notices. Any notices, statements, payments, or reports required by this
Agreement shall be considered given if sent by United States Certified Mail,
postage prepaid and addressed as follows:
If to CANCER CENTER:
Xxxxx X. Xxxxxxx, CPA
Manager, Sponsored Programs
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 0000
Xxxxxx, Xxxxx 00000
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19. Captions. 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 hereinabove written and have executed
two (2) originals each of which are of equal dignity.
THE UNIVERSITY OF TEXAS
INTROGEN THERAPEUTICS M.D. XXXXXXXX CANCER CENTER
By: /s/ XXXXX XXXXX By /s/ XXXXX X. XXXXXXX
--------------------- -----------------------------------------
Xxxxx Xxxxx Xxxxx X. Xxxxxxx, CPA
Managing Partner Manager, Sponsored Programs
I have read this agreement and
understand my obligations hereunder:
By: /s/ XXXX X. XXXXXXX
----------------------------------------
Xxxx X. Xxxxxxx, D.D.S., M.D.
Principal Investigator
By: /s/ XXXXXXX XXXXXXXX
----------------------------------------
Xxxxxxx Xxxxxxxx, M.D.
Ad interim Head, Division of Surgery
Payment Mailing Address:
The University of Texas
M.D. Xxxxxxxx Cancer Center
Attn.: Manager, Sponsored Programs
X.X. Xxx 000000
Xxxxxxx, Xxxxx 00000
Tax ID: 74-6001118-A1
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PROTOCOL
[ * ]
[*] 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
AMENDMENT, effective this 1st day of October, 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, INTROGEN THERAPEUTICS
(hereinafter referred to as "SPONSOR"), of the made
by these parties and dated the 21st day of September, 1995, regarding research
on the evaluation and study of the "Modification of Tumor Suppressor Gene
Expression in Head and Neck Squamous Cell Carcinoma (HSCC) with an Adenovirus
Vector Expression Wild-Type p53".
1. CANCER CENTER and SPONSOR agree that the Confidentiality provision addressed
in Paragraph 4(d) of the original Agreement be revised to the following:
d. Shall be required to be disclosed by law or regulation,
including without Stations for disclosure to Federal
regulatory agencies pursuant to approval for use; or
2. CANCER CENTER and SPONSOR agree that the Award and payment schedule addressed
in Paragraph 13 of the original Agreement be revised to the following:
AWARD. During the basic term of this Agreement as set forth below and
in consideration for CANCER CENTER's performance of the Research,
SPONSOR agrees to pay CANCER CENTER a fee equal to [ * ]:
a. SPONSOR will pay CANCER CENTER [ * ].
b. SPONSOR will pay CANCER CENTER's [ * ].
[ * ]
A third party clinical research organization ("CRO") may be engaged to
assist in conducting the Research, either at the request of CANCER CENTER or
SPONSOR. In that event, [ * ].
3. CANCER CENTER and SPONSOR agree that the Basic Term addressed in Paragraph 14
of the original Agreement be revised to the following:
BASIC TERM. This Agreement becomes effective as of the date first
written above and continues in force through December 31, 1996.
Thereafter, this Agreement can be extended for additional annual
periods upon the mutual written consent of CANCER CENTER and SPONSOR.
[*] 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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4. 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 entered
into on the 21st day of September, 1995 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. 1 and the
, the terms and conditions of this Amendment shall
prevail.
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 as of the date first hereinabove written.
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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 as of the date first hereinabove written.
INTROGEN THERAPEUTICS THE UNIVERSITY OF TEXAS
M.D. XXXXXXXX CANCER CENTER
By: /s/ XXXXX XXXXX By /s/ XXXXX X. XXXXXXX
----------------- ----------------------------------------
Xxxxx Xxxxx Xxxxx X. Xxxxxxx, CPA
President Manager, Sponsored Programs
Date: /12/28/95 Date: 12/31/95
I have read this agreement and understand my
obligations hereunder:
By: /s/ XXXX X. XXXXXXX
----------------------------------------
Xxxx X. Xxxxxxx, D.D.S., M.D.
Principal Investigator
By: /s/ XXXXXX XXXXXXXX
----------------------------------------
Xxxxxxx Xxxxxxxx, M.D.
Ad Interim Head, Division of Surgery
Payment Mailing Address:
The University of Texas
M.D. Xxxxxxxx Cancer Center
Attn.: Manager, Sponsored Programs
X.X. Xxx 000000
Xxxxxxx, Xxxxx 00000
Tax ID: 74-6001118-A1
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