Reference on checks
GTS 8530
RESEARCH AGREEMENT
THIS AGREEMENT is by and between IDT, INC., a corporation organized under
the laws of the Commonwealth of Pennsylvania whose offices are located at 2275
Swallow Hill Road #2500, Pittsburgh, Pennsylvania 15220 (hereinafter "SPONSOR")
and WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE, an educational institution
organized under the laws of the State of North Carolina, whose offices are
located on Medical Center Boulevard, Winston-Salem, North Carolina 27157 ("WAKE
FOREST").
1. Scope of Work. WAKE FOREST will use reasonable efforts to perform the
experiments and studies as required by the U.S. Food and Drug Administration
(FDA) to determine the safety and efficacy of implementing a method of heated
perfusion of chemotherapy drug in the treatment of intraperitoneal and other
cancers conceived and designed by WAKE FOREST ("the Method"). The Method
utilizes SPONSOR's The ThermoChem-HT SystemTM and incorporates necessary items
("disposables") to practice the Method (the "System"). The protocol is attached
as Appendix I and incorporated into this Agreement by reference (the "Research
Project"). The Research Project may be modified by mutual agreement in a duly
executed amendment to this Agreement. If there is a conflict between Appendix I
and the other terms of this Agreement, the other terms of this Agreement are
controlling. SPONSOR acknowledges that the primary mission of WAKE FOREST is
health care, education, and the advancement of knowledge, and consequently, all
services provided by WAKE FOREST under this Agreement will be performed in a
manner best suited to carry out that mission. WAKE FOREST does not guarantee
specific results of the Research Project.
This Agreement anticipates collaborative research between SPONSOR and
WAKE FOREST to evaluate and further improve the Method, including developing
applications for the use of the System, and to develop and/or improve
disposables and related accessories. As a condition of this Agreement, WAKE
FOREST agrees to conduct a pilot study and share its results with SPONSOR.
SPONSOR and WAKE FOREST will evaluate the data. Should the results be
favorable, the parties intend to pursue further avenues of collaboration. In
no event will SPONSOR offer for sale, sell or lease the System and the Method
except as pursuant
to a license agreement between the parties to be executed contemporaneously with
this Agreement.
2. Key Personnel. The Research Project will be performed under the
direction of Brian W. Loggie, M.D.C.M and Ronald A. Fleming, Pharm.D. In the
event they become unavailable to continue with the Research Project, the parties
will attempt to find a mutually acceptable substitute. In the event a mutually
acceptable substitute is not found, the Agreement may be terminated in
accordance with Section 9.1.
3. Term. The term of this Agreement is one year from the date on which IRB
approval and FDA approval of the IDE is obtained (the "Commencement Date").
4. Costs and Billings. SPONSOR agrees to pay WAKE FOREST as outlined in the
Budget and Payment Schedule attached (Appendix 2) in consideration for the
Research Project. Checks will be made payable to Wake Forest University School
of Medicine (Federal Identification Number 56-0532138), will reference this
Research Project, and will be mailed to the following address:
Wake Forest University School of Medicine
The Controller's Office
Medical Center Boulevard
Winston-Salem, NC 27157
5. Equipment.
5.1. SPONSOR will provide WAKE FOREST with the System including
Thermo-Chem HT disposable packs, in sufficient quantity to perform the work
hereunder, without charge, throughout the term of the Research Project. Title
to the System shall remain with Sponsor.
6. Publications.
6.1. Notwithstanding any other provisions in this Agreement, WAKE
FOREST is free to publish, present, or use any results arising out of the
performance of this Agreement for its own instructional, research, or
publication objectives provided that the publication, presentation or use
does not disclose any Information defined under Section 9. WAKE FOREST
agrees that any proposed publication or presentation relating to the Research
Project conducted under this Agreement will be submitted to SPONSOR at least
thirty (30) days prior to submission for publication or presentation. No
right of approval is granted to the SPONSOR. In the event that the proposed
publication or
presentation contains subject matter which needs patent protection, WAKE
FOREST will, upon written request that identifies potentially patentable
subject matter within the 3O-day review period, delay the publication or
presentation for a maximum of an additional ninety (90) days to allow for the
filing of patent application(s).
Should the SPONSOR also desire to publish any results arising out of the
performance of this Agreement, WAKE FOREST will be provided with a copy of any
proposed publication or presentation at least thirty (30) days prior to
submission for review. In the event that the proposed publication or
presentation contains subject matter which needs patent protection, SPONSOR
will, upon written request that identifies potentially patentable subject matter
within the 30-day review period, delay the publication or presentation for a
maximum of an additional ninety (90) days to allow for the filing of patent
application(s).
6.2. SPONSOR may issue press releases or other public communications at
any time concerning the Research Project, but shall furnish a copy thereof to
WAKE FOREST at least five (5) working days prior to public release. SPONSOR may
not use or refer to the name of WAKE FOREST, its likenesses, logos, or marks of
WAKE FOREST in any form without WAKE FOREST's prior written approval, which
approval will not be unreasonably withheld.
7. Intellectual Property
Either party will retain title to any patent or other intellectual
property rights in inventions made solely by its employees in the course of the
work under this Agreement. In the case of a question of inventorship, federal
law will rule. Any inventions made jointly by employees of SPONSOR and
employees of WAKE FOREST will be owned jointly.
8. Confidentiality
8.1. In recognition of WAKE FOREST as a non-commercial, academic
institution, SPONSOR agrees to limit to the extent possible the delivery of
confidential information to WAKE FOREST. WAKE FOREST agrees to use our best
efforts to hold in confidence, in accordance with this Section 8, any
information disclosed to WAKE FOREST by SPONSOR under this Agreement and
identified in writing as confidential (hereinafter "Information"). For the
purpose of this Agreement, "hold in confidence" means that WAKE FOREST will
protect the Information in the same manner in which
it protects its own confidential information of similar nature. The Information
will remain the property of the SPONSOR.
8.2. The obligations of WAKE FOREST to maintain confidential under this
Agreement will survive its expiration or termination and will endure for three
(3) years from the date of disclosure.
8.3. Information does not include:
(a) information that is already known to WAKE FOREST prior to
the effective date;
(b) information that is or becomes publicly known through no
fault of WAKE FOREST;
(c) information that has been or is disclosed to WAKE FOREST by
a third party who, to WAKE FOREST's knowledge, was not or
is not under any obligation of confidence or secrecy to
SPONSOR at the time said third party discloses to WAKE
FOREST;
(d) information that is developed by employees of WAKE FOREST
who had no knowledge of the Information disclosed by
SPONSOR to WAKE FOREST under this Agreement and that is
identified in writing as confidential;
(e) Information that is approved for release by written
authorization of the SPONSOR; and
(f) Information that is required to be disclosed by law,
provided WAKE FOREST promptly notifies the SPONSOR in
writing of such lawful disclosure.
9. Termination
9.1. If WAKE FOREST fails to continuously staff the project with
personnel in accordance with Section 2, WAKE FOREST is not in default under this
Agreement but the SPONSOR may terminate this Agreement upon 30 days written
notice.
9.2. In the event that either party defaults or breaches any material
provision of this Agreement, the other party may terminate this Agreement upon
ninety (90) days written notice to the party in default or breach. The
Agreement will continue in force and effect, however, if the party in default or
breach (within 90 days of the receipt of such notice) cures such default or
breach.
9.3. If either party should become insolvent or should make any
assignment for the benefit of creditors, or should be
adjudged bankrupt, or should file a petition in bankruptcy, or is named as
debtor in an involuntary bankruptcy proceeding, or if a receiver or trustee of
the property of either party is appointed, then this Agreement, at the option of
the other party, will terminate, effective on the date notice of such
termination is given.
9.4. SPONSOR may terminate this Agreement at any time for any reason
upon thirty (30) days written notice; provided, however, that early termination
by SPONSOR for any reason other than the fault of WAKE FOREST DOES NOT RELIEVE
SPONSOR OF THE OBLIGATION OF FULL SALARY SUPPORT AND FRINGE BENEFITS FOR THE
RESEARCH NURSE AS OUTLINED IN THE BUDGET AND PAYMENT SCHEDULE (APPENDIX 2). All
other payments, including financial obligations made prior to the termination
date, shall be paid by SPONSOR within thirty (30) days of receiving a final
invoice from WAKE FOREST.
9.5. Termination of this Agreement for any reason will not relieve the
parties of their duties and obligations which by their nature will survive
termination. Obligations under Section 12 of this Agreement will survive as
long as the Method utilizes the System.
9.6. WAKE FOREST DISCLAIMS ALL WARRANTIES WITH REGARD TO ITS METHOD,
INCLUDING ALL IMPLIED WARRANTIES OR MERCHANTABILITY AND FITNESS, IN NO EVENT
SHALL WAKE FOREST BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES
OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER
IN AN ACTION OR CONTRACT, NEGLIGENCE OR OTHER TORTIOUS ACTION, ARISING OUT OF OR
IN CONNECTION WITH THE USE OR PERFORMANCE OF THE METHOD.
10. Assignment. Neither party may assign this Agreement or any part of it
without the written consent of the other party.
11. Miscellaneous
11.1. The headings in this Agreement are intended solely for convenience
or reference and will be given no effect in the construction or interpretation
of this Agreement.
11.2. This Agreement, including any attached appendices, supersedes all
prior oral and written proposals and communications, if any, and sets forth the
entire Agreement of the parties with respect to its subject matter hereof and
may not be altered or amended except in writing, signed by an authorized
representative of each Party.
11.3. The construction and enforcement of this Agreement will be
governed by the laws of the State of North Carolina, United States of America,
without regard to principles of choice of law. The parties acknowledge that
this contract is entered into and will be performed in North Carolina.
11.4. No waiver of any default, condition, provision or breach of this
Agreement will be deemed to imply or constitute a waiver of any other like
default, condition, provision or breach of this Agreement.
11.5. If any section, term, condition or provision of this Agreement can
be proven by a court of competent jurisdiction, to be-invalid or unenforceable,
or if any section, term, condition or provision is found to violate or
contravene the laws of the State of North Carolina, then the section, term,
condition or provision so found will be deemed severed from this Agreement, but
all other sections, terms, conditions and provisions will remain in full force
and effect.
11.6. Nothing contained herein will be construed as establishing an
employer-employee, joint venture, or principal-agent relationship between the
parties. In addition, neither party will have the right to incur any debt or
expense for the account of the other party except as may expressly be agreed
upon by separate written agreement.
12. Indemnity and Insurance
SPONSOR will indemnify, defend, and hold harmless WAKE FOREST from any
suit, action, liability, claim, demand, judgment, and expense arising out of the
fault of SPONSOR or the System. SPONSOR agrees that if any such claim is
asserted or such suit brought against WAKE FOREST, or its officers, trustees,
employees, agents, or subcontractors or their employees, SPONSOR will defend
such claim or suit at the expense of SPONSOR. SPONSOR will cooperate with WAKE
FOREST in the management of such claim or suit. The counsel chosen by SPONSOR
must be reasonably acceptable to WAKE FOREST and agree to represent WAKE FOREST.
SPONSOR will not settle or compromise any claim or action in a manner that
imposes any restrictions or obligations on WAKE FOREST without WAKE FOREST's
written consent, which consent will not be unreasonably withheld.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement signed
by their respective officers duly authorized as of the date and year written.
WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE IDT, INC.
BY BY
-------------------------- ----------------------
NAME: Lawrence D. Smith NAME: Glenn Keeling
TITLE: Associate Dean, Research TITLE: President
DATE DATE March 16, 1999
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APPENDIX 1
The Protocol
APPENDIX 2
Drs. Brian W. Loggie and Ronald A. Fleming agree to conduct a Phase I
trial of The ThermoChemHT SystemTM (the "System") of IDT, Inc. (IDT, Inc.,
hereafter referred to as "SPONSOR") in patients with disseminated
intraperitoneal cancer. To assist in the SPONSOR's the System IDE submission to
the Food and Drug Administration ("FDA"), Drs. Loggie and Fleming will provide
to the SPONSOR a clinical protocol for inclusion in an IDE application prepared
by the SPONSOR for submission to the FDA. A copy of the IDE will be provided to
Drs. Loggie and Fleming at the time of the IDE submission. After the FDA has
reviewed the IDE, the SPONSOR will contact Drs. Loggie and Fleming and provide
them with specific details concerning the conduct of the Phase I trial, the
number of study patients required, study endpoints, and other items requested by
the FDA for the clinical evaluation of the System. Although the precise number
of subjects to be evaluated is not known, a payment schedule and personnel
budget breakdown to cover the cost of the Phase I study is provided below.
The following items will be provided by the SPONSOR to Drs. Loggie and Fleming:
- - The ThermoChem-HTSystemTM(received January, 1998) and consumable supplies
pertinent to IRB-approved use of the device for the number of patients
covered under this Agreement.
- - Funding for one year from the effective date of the Research Agreement as
described below:
1) Funding for partial support of one of the principal investigators
[$3,593 (5% effort)], a clinical data manager [$6,672 (20%
effort)] and a biostatistician [$2,884 (5% effort)] to collect and
record data in a manner acceptable to FDA requirements and
facilitate reporting of data to SPONSOR and the FDA.
2) Minimum payment of $10,000 for non-assigned research funds, which
use is to be directed by Drs. Loggie or Fleming for the purposes
of the before-mentioned Phase I trial (analysis of drug
concentrations in plasma and perfusate and related supplies) and
other areas of mutual interest including, but not limited to,
Phase 1, II, III trials of hyperthermia, regional perfusion, and
new perfusion applications.
The parties will meet quarterly in person or by telephone to review the study
progress. Where appropriate in scientific articles and in published articles,
the collaborators will acknowledge the support of the SPONSOR.
PAYMENT SCHEDULE
- - $23.000 at the initiation of the Project with the remainder due after the
accrual of the fifth and last patient on the Phase I trial.
- - Funds for travel to two national or international meetings for both Drs.
Loggie and Fleming (including travel expense reimbursement and per diem
payment not to exceed $1,000 per day, in accordance with WAKE Forest's
customary policies) for presentation of data regarding the System to be
agreed upon by WAKE FOREST and the SPONSOR.
- - Funds for travel for the study nurse to attend one scientific meeting
(including travel expense reimbursement and per diem payment not to exceed
$1,000 per day, in accordance with WAKE FOREST's customary policies) to be
agreed upon by WAKE FOREST and the SPONSOR.
BUDGET
Base Fringe
Name Role %Effort Salary Salary Benefits TOTAL
- -------------------------------------------------------------------------------------------------
Ronald Fleming Co-P.I. 10% $56,580 $5,658 $1,528 $7,186
Greg Russell Biostatistician 5% $44,770 $2,239 $645 $2,884
(28.8% rate)
Diane Garske Data Manager 20% $27,872 $5,574 $1,226 $6,800
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(22% rate)
TOTAL PERSONNEL
EXPENSES $16,870
Phase I Trial Expenses (analysis of drug concentrations in plasma and
perfusate and related supplies); and
expenses covering other areas of mutual interest $10,000
TOTAL $26,870
Indirect Costs @25% $ 6,718
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GRAND TOTAL $33,588
Plus travel and Milestone Payments