SPONSORED LABORATORY STUDY AGREEMENT
THIS Agreement is made this 7th day of July, 1997, between The University
of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas
77030 ("Institution"), a component of The University of Texas System ("System"),
and IDT, Inc., 2275 Swallow Hill Road, Building 2500, Pittsburgh, PA 15220
("Sponsor"), to conduct a laboratory study and evaluation ("Study").
Institutional 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 Project, "Pre-Clinical Studies for
Phase I/II Trial of a Thermochemotherapy Hemi-Perfusion of Patients with
Pelvic or Lower Extremity Recurrences" as described in Exhibit A attached
hereto and incorporated herein. The Study will be supervised by Stephen
P. Tomasovic, Ph.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 to Institution the long-term loan of a
Biologic-HT System and System ($250,000 retail) and the HT Disposable
Kits for the pig perfusions ($6,000 per kit retail) at no cost for the
conduct of the Study.
2. AWARD
2.1 In consideration for performance of the Study by Institution, Sponsor
shall pay Institution Nine Thousand Five Hundred Twelve and 50/100
Dollars (9,512.50) for Study expenses and other related costs. This
amount, shown by approximate category of expense in Exhibit B attached
hereto for information only, is payable within thirty (30) days of the
date herein above.
3. TERM
3.1 This Agreement shall continue in force until the earlier of completion of
the Study as mutually agreed upon by the parties or within two (2) months
of delivery of the System; 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.
4. INDEMNIFICATION
4.1 Institution shall, to the extent authorized under the Constitution and
laws of the State to 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 the 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 claim 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 follow 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 thirty (30) days prior to publication or release.
5.2 Except as otherwise required by law or regulatior4 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 non-releasing party, but such
approval shall not be unreasonably withheld.
IDT anticipates press releases when appropriate and will submit them for
review prior to release.
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 parry 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. GENERAL
6.1 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.
6.2 Any conflicts between the Protocol and this Agreement are controlled by
this Agreement.
6.3 This Agreement shall be construed and enforced in accordance with the
laws of the State of Texas.
6.4 This Agreement anticipates educational training and may involve health
science postgraduates and other students of the Institution.
IN WITNESS WHEREOF, Institution and Sponsor hereby enter into this
Agreement, effective as of the date set forth above, and execute
two (2) original counterparts.
IDT, Inc. The University of Texas
M.D. Anderson Cancer Center
By: Glenn Keeling /s/ By: Donna S. Gilberg /s/
------------------- --------------------------
Glenn Keeling Donna S. Gilberg, CPA
President Manager, Sponsored Programs
Date: 7/8/97 Date: 7/2/97
---------------- -------------------------
I have read this agreement and
understand my obligation hereunder.
By: Stephen P. Tomasovic /s/
---------------------------
Stephen P. Tomasovic, Ph.D.
Principal Investigator
Make Payment to:
The University of Texas
M.D. Anderson Cancer Center
Attn: Donna S. Gilberg, CPA
Manager, Sponsored Programs
P.O. Box 297402
Houston, TX 77297
Tax I.D. 74 6001118A1
EXHIBIT B
SPONSORED LABORATORY STUDY AGREEMENT
BETWEEN
THE UNIVERSITY OF TEXAS M.D. ANDERSON CANCER CENTER
AND
IDT, INC.
"PRE-CLINICAL STUDIES FOR PHASE I/II TRIAL OF A THERMOCHEMOTHERAPY
HEMI-PERFUSION OF PATIENTS WITH PELVIC OR LOWER EXTREMITY
RECURRENCES'"
The approximate distribution of expenses related to the Study described in the
covering Agreement is as follows:
Charges Per Pig
Pig cost $ 250.00
Operating room time (4 h) 125.00
Gas anesthesia 125.00
Disposables 170.00
Euthanasia & disposal 30.00
Tc-99m 25.00
Ultra Tag kit 36.00
Total Estimated Cost Per Pig $ 761.00
Total Direct Costs (10 pigs) $7,610.00
Indirect Costs (@ 25%) $1,902.50
Total Costs $9,512.50
These expenses are provided for information only. Institution reserves the
right to modify the distribution of such expenses as necessary in the
circumstances, provided that the stipulated total cost of $9,512.50 is not
exceeded.