NON-GOVERNMENTAL CLINICAL STUDY AGREEMENT
("Clinical Trials")
THIS Agreement is made this 10 day of September 1997, between The University of
Texas Medical Branch, 000 Xxxxxxxxxx Xxxx., Xxxxxxxxx, XX ("Institution"), a
component of The University of Texas System ("System"), and IDT, Inc., 0000
Xxxxxxx Xxxx Xxxx, Xxxx 00xx, Xxxxxxxxxx, XX ("Sponsor"), to conduct a clinical
study and evaluation ("Study"). Institution and Sponsor agree to follows:
1. PROTOCOL
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 study entitled Phase I Trial of
Perfusion-Induced Systemic Hyperthermia for Metastatic Non-Small Cell Lung
Carcinoma a Concept Feasibility Study, as described in Exhibit A
("Protocol"). The Study will be supervised by Xxxxxx Xxxxxxxxxxxxxx, M.D.
("Principal Investigator") at Institution with assistance from associates
and colleagues as required.
2 Sponsor agrees to engage the services of Institution to conduct the Study
and further agrees to provide at no cost to Institution the equipment and
supplies for the conduct of the Study.
2. AWARD
1 In consideration for performance of the Study by Institution, Sponsor shall
pay Institution Ninety-nine thousand seven hundred eighty dollars and
ninety cents ($99,780.90) for Study expenses for the clinical study of
approximately five (5) patients and other related costs. This amount,
shown by approximate category of expense in Exhibit B, is payable in two
(2) equal installments of Forty-nine thousand eight hundred ninety dollars
and forty-five cents (449,890.45) each by Sponsor to Institution prior to
the start of the study. Institution will invoice Sponsor for the first
payment upon execution of this agreement.
Checks should be made payable to The University of Texas Medical Brance,
and mailed to The University of Texas Medical Branch, Research
Administrative Services, P.O. Box 200790.
(OVERNIGHT MAIL: UNIVERSITY OF TEXAS MEDICAL BRANCH, RESEARCH
ADMINISTRATIVE SERVICES, 601 XXXXXX (BOX 200790), HOUSTON, TX 77002.)
3. TERM
1 This agreement shall continue in force until the earlier of completion of
the Study or as mutually agreed upon by the parties, provided, however that
either party may terminate the Agreement by giving thirty (30) days advance
notice to the other.
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 Upon termination of this Agreement, Institution shall return Sponsor's
materials and equipment to Sponsor.
4. INDEMNIFICATION
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 Institutions, 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 or Sponsor, its officers, agents or employees, or any
person or entity not subject to Institution's supervision or control.
2 Sponsor shall indemnify and hold harmless System, Institution, their
Regents, officers, agents and employees from any liability or loss
resulting from judgements 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 CONFIDENTIALLY
1 The parties reserve the right to publish or otherwise make public the data
resulting from the Study. The party wishing to publish or make public
shall submit any such manuscript or release to the other party for comment
prior to publication or release.
2 Except as otherwise required by law or regulation, neither party shall
release or distribute any materials or information containing the name of
the 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 release when
appropriate and will submit them for review prior to release.
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
1 "Invention" shall mean any discovery, concept, or idea, whether or not
available, made during the conduct of the study and arising directly from
the performance of the study, including but not limited to processes,
methods, software, tangible research products, formulas and techniques,
improvements thereto, and know-how related thereto.
2 Institution agrees that the Principal Investigator will promptly disclose
to its Intellectual Property Committee and to SPONSOR any Inventions made
by the Institution and/or the Principal Investigator. It is agreed that
all Inventions and any information with respect thereto shall be subject to
confidentially obligations commensurate with those set forth in Section 5
herein.
3 Any Inventions that originate solely with the Principal Investigator, or
any other Institution agent or employee associated with this study (jointly
or severally referred as "Inventor") shall be the property of the
Institution. If Inventor is a co-inventor with SPONSOR, its agents or
employees, Institution and SPONSOR shall jointly own the Invention. Any
Inventions that originate solely with any agent or employee of SPONSOR
shall be property of SPONSOR. To the extent that SPONSOR pays all patent
expenses for an Invention, Institution does hereby grant to SPONSOR an
exclusive option to acquire an exclusive, worldwide royalty-bearing license
to any invention in which Institution has an ownership interest. SPONSOR
shall indicate its intention to exercise its option to Invention's
disclosure to SPONSOR. If
SPONSOR decides to exercise its option, the terms shall be negotiated in
good faith within one hundred twenty (120) days of the date the option is
exercised, or within such time as the parties may mutually agree in
writing.
4 If negotiations between SPONSOR and the Institution terminate and the
Institution thereafter negotiates a license agreement with a third party on
substantially better terms than those last offered to SPONSOR, SPONSOR
shall be given the first right to refuse such terms for a period of sixty
(60) days from the date of SPONSOR's receipt of a draft of such license
agreement from Institution.
7. GENERAL
1 This Agreement, including the attached Exhibits 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
supersuded hereby. No agreements altering or supplementing the terms may
be made except by a written document signed by the duly authorized
representatives of the parties.
2 Any conflicts between the Protocol and this Agreement are controlled by
this Agreement.
3 This Agreement shall be construed and enforced in accordance with the laws
of the State of Texas
4 This Agreement anticipates educational training and may involve health
science postgraduates and other students of the Institution.
IDT, INC. THE UNIVERSITY OF TEXAS MEDICAL
BRANCH
By: Xxxxx Xxxxxxx /s/ By: Xxxxx Xxxxxxxxx /s/
--------------------------- ------------------------
Name: Xxxxx Xxxxxxx Name: Xxxxx Xxxxxxxxx/s/
-------------------------- ---------------------
Title: President Title: Director, Instutional
------------------------- Review Coordination
-------------------------
Date: September 10, 1997 Date: 9/5/97
-------------------------- --------------------
I have read this Agreement and understand my obligations hereunder.
By: Xxxxxx X. Xxxxxxxxxxxxxx M.D. /s/
---------------------------------------
(Principal Investigator)
Name: Xxxxxx X. Xxxxxxxxxxxxxx M.D. /s/
----------------------------------
Date: 9/5/97
----------------------------------
NON-GOVERNMENTAL PRE-CLINICAL STUDY AGREEMENT
("Pre-Clinical Trials")
THIS AGREEMENT is made this 24th day of June, 1996, between The University of
Texas Medical Branch ("INSTITUTION"), a component of The University of Texas
System ("SYSTEM"), and IDT, Inc., ("SPONSOR"), to conduct a clinical 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 study entitled Xxxx-Venous Perfusion-Induced
Systemic Hyperthermia ("PROTOCOL"). The STUDY will be supervised by Xxxxxx
X. Zwischenberber, MD ("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 equipment and
supplies for the conduct of the STUDY.
2. AWARD
2.1 In consideration for performance of the STUDY by INSTITUTION, SPONSOR shall
pay INSTITUTION Twenty-eight Thousand One Hundred and Ten Dollars
($28,100.00) for study expenses for the study of approximately eight (8)
animals and other related costs. This amount, shown by approximate category
of expense is Exhibit B and is payable in two equal installments prior to
the start of the study. INSTITUTION will invoice SPONSOR for the first
payment upon execution of this agreement.
Checks should be made payable to The University of Texas Medical Branch,
and mailed to The University of Texas Medical Branch, Research
Administrative Secretaries, X.X. Xxx 000000, Xxxxxxx, XX 00000-0000.
(OVERNIGHT MAIL: UNIVERSITY OF TEXAS MEDICAL BRANCH, RESEARCH
ADMINISTRATIVE SERVICES, 601 XXXXXX (bOX #200790).)
3. TERM
3.1 This agreement shall continue in force until completion of the STUDY as
manually agreed upon by the parties; 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 the 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 to SPONSOR.
4. INDEMNIFICATION
4.1 INSTITUTION shall, to the extent authorized under the Texas Constitution
and the 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 or 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 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 obligations 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 CONFIDENTIALLY
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 party or any of its employees without prior approval by an authorized
representative of the non-leasing party, but said 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 information identified as proprietary or
confidential 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. GENERAL
6.1 This agreement, including the attached Exhibits A and B, constitutes the
entire and only Agreement between the parties relating to the STUDY, and
all prior negotiation, 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 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.
EXHIBIT B
NON-GOVERNMENTAL STUDY AGREEMENT BUDGET
Between
The University of Texas Medical Branch
and
IDT, Inc.
XXXX-VENOUS PERFUSION-INDUCED SYSTEMIC HYPERTHERMIA
The approximate distribution of expenses related to the STUDY described in the
covering Agreement is as follows:
Salaries (including fringe benefits) $ 9,000
Animals and supplies $ 11,240
Laboratory Costs $ 2,248
----------------
Total Direct Costs $ 22,488
Indirect Costs (institutional overhead 25%) $ 5,622
TOTAL COST $ 28,100
Such 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 is not exceeded. Further, the above data
is predicated on the evaluation of eight animals; if the total number of
evaluated animals is greater or less than said number, the parties may increase
or decrease the grant amount accordingly.
SPONSOR: IDT, INC. UNIVERSITY OF TEXAS MEDICAL BRANCH
By By
---------------------- ----------------------
Name: Name: Xxxx Xxxxx
-------------------
Title: Title: Director, Research
------------------ Administrative Services
Date: Date:
-------------------- --------------------
I have read this agreement and understand my obligations hereunder.
By
----------------------------------
Principal Investigator
Date:
--------------------------------
