1
Exhibit 10.12
LS95-035
THIS Agreement is made this 21st day of September, 1995, between The
University of Texas M.D. Xxxxxxxx Cancer Center, 0000 Xxxxxxxx Xxxxxxxxx,
Xxxxxxx, Xxxxx 00000 ("Institution"), a component of The University of Texas
System ("System"), and Introgen Therapeutics, 000 Xxxxxxxx Xxxxxx, Xxxxx 0000,
Xxxxxx, Xxxxx 00000 ("Sponsor"), to conduct a laboratory study and evaluation
("Study"). Institution and Sponsor agree as follows:
1. PROTOCOL
1.1 Institution agrees to use its best efforts to conduct the
Study, as an independent contractor, in accordance with
Institutional policy, applicable laws and regulations and the
Project, "Over-expression of WT-p53 Protein by Ad5cmv-p53 in
Human Gliomas", as described in Exhibit A attached hereto and
incorporated herein. The Study will be supervised by X.X.
Xxxxxx Xxxx, M.D. ("Principal Investigator"), at Institution,
with assistance from associates and colleagues as required.
1.2 Sponsor agrees to engage the services of Institution to
conduct the Study and further agrees to provide at no cost to
Institution the Study material for the conduct of the Study.
2. AWARD
2.1 In consideration for performance of the Study by Institution,
Sponsor shall pay Institution [*]
3. TERM
3.1 This Agreement shall continue in force until the earlier of
completion of the Study as upon by the parties or Twelve (12)
months from the date set forth above; provided, however, that
either party may terminate the Agreement by giving thirty (30)
days advance notice to the other.
3.2 Upon early termination of this Agreement, Sponsor shall be
liable for all reasonable costs incurred or obligated by
Institution at the time of such termination, subject to the
maximum amount specified in Article 2. Sponsor shall pay
Institution for such costs within thirty (30) days of receipt
of an invoice for same.
3.3 Upon termination of this Agreement, Institution shall return
Sponsor's materials and equipment to 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.
2
4. INDEMNIFICATION
4.1 Institution shall, to the extent authorized under the
Constitution and laws of the State of Texas, indemnify and
hold Sponsor harmless from liability resulting from the
negligent acts or omissions of Institution, its agents or
employees pertaining to the activities to be carried out
pursuant to the obligations of this Agreement; provided,
however, that Institution shall not hold Sponsor harmless from
claims arising out of the negligence or willful malfeasance of
Sponsor, its officers, agents, or employees, or any person or
entity not subject to Institution's supervision or control.
4.2 Sponsor shall indemnify and hold harmless System, Institution,
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 obligation of this Agreement, including but not limited
to the use by Sponsor of the results of the Study; provided,
however, that the following is excluded from Sponsor's
obligation to indemnify and hold harmless:
a. the negligent failure of Institution to
comply with any applicable governmental
requirements or to adhere to the terms of
the Protocol; or
b. the negligence or willful malfeasance by a
Regent, officer, agent, or employee of
Institution or System.
5. PUBLICATION AND CONFIDENTIALITY
5.1 The parties reserve the right to publish or otherwise make
public the data resulting from the Study. The party so wishing
to publish or make public shall submit any such manuscript or
release to the other party for comment prior to publication or
release.
5.2 Except as otherwise required by law or regulation, neither
party shall release or distribute any materials or information
containing the name of the other party or any of its employees
without prior written approval by an authorized representative
of the nonreleasing party, but such approval shall not be
unreasonably withheld.
5.3 Each party shall hold in confidence for three (3) years after
the termination of this Agreement any confidential information
identified as confidential and obtained from the other party
during the course of this Study. Nothing herein, however,
shall prevent Institution or any other component of System
from using any information generated hereunder for ordinary
research and educational purposes of a university.
6. INTELLECTUAL PROPERTY RIGHTS
6.1 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
-2-
3
obligations of this Agreement; (ii) is conceived and reduced
to practice during the term of the Agreement as defined in
Article 3 hereinabove; 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 Institution personnel as
identified in Article I hereinabove or agents of Institution
shall be the sole property of Institution. Inventions made
jointly by employees or agents of Institution and Sponsor
shall be jointly owned by Institution and Sponsor.
6.2 In the event that an Invention is made, either solely by
employees or agents of Institution or jointly by employees or
agents of Institution and Sponsor, Institution 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, Institution
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.
6.3 If, after consultation with Sponsor, it is agreed by the
parties that a patent application should be filed, Institution
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 notifies Institution 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
Institution on the disposition of rights to the Invention,
then Institution may file such application at its own expense,
and Sponsor shall have no rights to such Invention.
Institution 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 Institution
or by the respective patent office.
6.4 Under the terms of the "Patent and Technology License
Agreement between Institution and Introgen (Intron)
Therapeutics" dated effective July 20, 1994, Institution
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
Institution pursuant to Section 6.2 hereinabove, to give
written notice to Institution to include any invention in the
above referenced licensed agreement.
-3-
4
7. GENERAL
7.1 This Agreement, including the attached Exhibit A and B,
constitutes the entire and only Agreement between the parties
relating to the Study, and all prior negotiations,
representations, agreements, and understandings are superseded
hereby. No agreements altering or supplementing the terms
hereof, including the exhibits attached hereto, may be made
except by a written document signed by the duly authorized
representatives of the parties.
7.2 Any conflicts between the Protocol and this Agreement are
controlled by this Agreement.
7.3 This Agreement shall be construed and enforced in accordance
with the laws of the State of Texas.
7.4 This Agreement anticipates educational training and may
involve health science postgraduates and other students of the
Institution.
-4-
5
IN WITNESS WHEREOF, Institution and Sponsor hereby enter into this
Agreement, effective as of the date first set forth above, and execute two (2)
original counterparts.
Introgen Therapeutics The University of Texas
M.D. Xxxxxxxx Cancer Center
By: /s/ XXXXX X. XXXXX By: /s/ XXXXX X. XXXXXXX
------------------ -------------------------------
Xxxxx X. Xxxxx Xxxxx X. Xxxxxxx, CPA
President Manager, Sponsored Programs
Date: 21 September 1995 Date: October 3, 1995
I have read this agreement and
understand my obligations hereunder:
By: /s/ W.K. XXXXXX XXXXX
-------------------------------
X.X. Xxxxxx Xxxx, M.D.
Principal Investigator
By: /s/ XXXXXX X. XXXXX
-------------------------------
Xxxxxx X. Xxxxx, M.D.
Chairman, Department of
Neuro-Oncology
By: /s/ XXXXXX X. XXXX, XX.
-------------------------------
Xxxxxx X. Xxxx, Xx., M.D.
Head, Division of Medicine
Make Payment to:
The University of Texas
M.D. Xxxxxxxx Cancer Center
Attn: Manager, Sponsored Programs
X.X. Xxx 000000
Xxxxxxx, XX 00000
Tax I.D. 74 6001118 A1
-5-
6
EXHIBIT A
[*]
[*] 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.