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EXHIBIT 10.15
Agreement, made this 3rd day of May 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 at 0000 Xxxxxxxx Xxxx., Xxxxxxx, Xxxxx 00000,
and SpectRX (hereinafter referred to as "SPONSOR"), located at 0000 X Xxxxx
Xxxxx, Xxxxxxxx, Xxxxxxx 00000.
WITNESSETH:
WHEREAS, CANCER CENTER has research facilities and situations which
would allow investigation and study of the non-invasive clinical study of
non-invasive bilirubin monitor invented by Xx. Xxxxxx Xxxxxxx 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 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 Xxxxxx X. Xxxxxxx, Ph.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. The Principal Investigator shall provide SPONSOR with all
research conclusions, analyses, and raw data, which will be marked
"CONFIDENTIAL" upon conclusion of this Agreement.
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
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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 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 or 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, SPONSOR
will prepare or co-prepare and file appropriate United States
and foreign patent applications on Inventions made under this
Agreement and SPONSOR will provide CANCER CENTER with the
opportunity to review and provide comments and recommendations
on all such filings. CANCER CENTER has the right to assume
patent filing responsibility if SPONSOR fails to perform.
SPONSOR will provide CANCER CENTER 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 will pay the cost of preparing,
filing and maintenance thereof. If SPONSOR notifies 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. Upon execution of this Agreement, CANCER CENTER hereby grants
SPONSOR an option, for a period of twelve (12) months ("Option
Period"), to negotiate and acquire an exclusive, world-wide,
royalty-bearing license to the non-invasive bilirubin monitor
(U.S. Patent No. 5,353,790) invented by Xx. Xxxxxx Xxxxxxx and
any 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. The Option Period may be extended for a period of
six (6) months upon mutual agreement of SPONSOR and CANCER
CENTER.
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e. During the Option Period, the parties agree to enter into good
faith negotiations regarding the terms and conditions of said
license and further agree to negotiate license fee rates and
other payments which are fair and reasonable to both parties.
f. In the event that parties fail to reach an agreement regarding
the terms and conditions of said license, within the Option
Period pursuant to Articles 3(d) and (e) hereinabove, CANCER
CENTER shall have the right to enter into license agreements
concerning the same Inventions with third parties.
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. Information which
is orally transmitted by the disclosing party and is identified at the
time as being of a proprietary or trade-secret nature shall be
considered by the receiving party to be proprietary information,
provided that the disclosing party notifies the receiving party in
writing within thirty (30) days of the oral transmission, identifying
specifically the information transmitted. 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:
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.
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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 at least thirty (30) days 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. SPONSOR shall notify CANCER CENTER in
writing within thirty (30) days of receipt of such draft whether such
draft contains information deemed to be confidential under the
provisions of Article 4, or information that if published within thirty
(30) days would have an adverse effect on a patent application in which
SPONSOR owns full or part interest, or intends to obtain an interest
from CANCER CENTER pursuant to this Agreement. In the latter case
SPONSOR has the right to request a delay and CANCER CENTER agrees to
delay said publication for a period not exceeding ninety (90) days. In
any such notification, SPONSOR shall indicate with specificity to what
manner and degree CANCER CENTER may disclose said information. CANCER
CENTER shall have the final authority to determine the scope and
content of any publication, provided that such authority shall be
exercised with reasonable regard for the commercial interests of
SPONSOR. It is the intent of the parties that no publication will
contain any of confidential information disclosed by SPONSOR without
SPONSOR's prior written permission.
6. Publicity. CANCER CENTER acknowledges SPONSOR's intention to distribute
periodically informational 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 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
employees, agents and assigns in conjunction with this evaluation.
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
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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 Article 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 and such consent will not
be unreasonably withheld; 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 judgements 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 of Eight Thousand
Seven Hundred Fifty and No/100 Dollars ($8,750.00) for expenses and
other related costs incurred in conjunction with the Research. This
fee, as shown by approximate category of expense in the attached
Exhibit II which is attached hereto and is incorporated herein by
reference, for information only, shall be payable in one (1)
installment of Eight Thousand Seven Hundred Fifty and No/100 Dollars
($8,750.00) by SPONSOR to CANCER CENTER. This installment shall be due
within thirty (30) days of the date of execution of this Agreement.
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14. Basic Term. This Agreement as it relates to the performance of the
Research, 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 one (1) month after the same.
15. Default and Termination. In the event that either party to this
Agreement shall be in default of any of its material obligations
hereunder and shall fail to remedy such default within thirty (30) days
after receipt of written notice thereof, the party not in default shall
have the option of terminating this Agreement by giving written notice
thereof, notwithstanding anything to the contrary contained in this
Agreement. Termination of this Agreement shall not affect the rights
and obligations of the parties which accrued prior to the effective
date of termination. SPONSOR shall pay CANCER CENTER for all reasonable
expenses incurred or committed to be expended as of the effective
termination date, subject to the maximum amount as specified in Article
13.
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, 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
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If to SPONSOR:
Mr. Xxxx Xxxxxxx
President and CEO
SpectRX
0000 X Xxxxx Xxxxx
Xxxxxxxx, Xxxxxxx 00000
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.
SPECTRX THE UNIVERSITY OF TEXAS
M.D. XXXXXXXX CANCER CENTER
By: /s/ Xxxx X. Xxxxxxx By: /s/ Xxxxx X. Xxxxxxx
--------------------------- --------------------------------
Xxxx Xxxxxxx Xxxxx X. Xxxxxxx, CPA
President and CEO Manager, Sponsored Programs
Date: Date: May 2, 1995
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I have read this agreement and
understand my obligations hereunder:
By: /s/ Xxxxxx X. Xxxxxxx 5/1/95
--------------------------------
Xxxxxx X. Xxxxxxx, Ph.D.
Principal Investigator
By: /s/ Xxxxxx xxx Xxxxxxxxxx
--------------------------------
Xxxxxx xxx Xxxxxxxxxx, M.D.
Chairman, Dept. of Urology
By: /s/ Xxxxxxx Xxxxxxxx
--------------------------------
Xxxxxxx Xxxxxxxx, M.D.
Interim Head, Div. of Surgery
Mail Payment To:
The University of Texas
MD. Xxxxxxxx Cancer Center
Attn: Manager, Sponsored Programs
X.X. Xxx 000000
Xxxxxxx, XX 00000
Tax I.D.: 74 6001118 A1
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EXHIBIT I
BACKGROUND
The work consists of analyzing optical measurements on about 96 infants
in the neonatal intensive care unit at Xxxxxx Hospital, which measurements have
already been conducted under an approved human research protocol (Xx. Xxxxx
Xxxxxxx, Pediatrics, UTHSCH).
The work was conducted by a registered nurse and the cost was $7,000
paid by Xxxxxx Xxxxxxx from the accounts of the Laser Biology Research
Laboratory. At this time, the remaining work consists of analysis by Xx. Xxxxxxx
of the data base, which consists of 467 spectra on various sites and at various
times on the infants.
PROPOSED WORK
1. Collect, format and review data collected from bilirubin instrument for
presentation. Include race, age, gender and serum bilirubin levels as available
in data base along with instrument data (raw and processed).
2. Apply the analysis technique described in the patent.
3. Calculate a correlation coefficient and a standard error term for the
analysis outcome vs the measured serum bilirubin levels for the data base.
Provide graphical presentations of the measured (serum) vs predicted (cutaneous)
bilirubin levels.
4. Plot time courses of repeated measurements on any individuals which
were measured on multiple days.
5. Present the data for the most darkly pigmented infants vs the lightly
pigmented infants (similar to item 3 above).
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BUDGET
DIRECT COSTS
Miscellaneous Expenses $7,000
INDIRECT COSTS (25%) $1,750
TOTAL $8,750
ANIMALS
None.
HUMANS
No more measurements on humans. Identities of patients are kept
confidential.
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[UNIVERSITY OF TEXAS LETTERHEAD]
August 11, 1995
Xxxxx X. Xxxxxx
Chief Operating Officer
SpectRX
0000X Xxxxx Xxxxx Xxxxxxxx, XX 00000
Dear Xx. Xxxxxx:
This will acknowledge receipt of your check dated 07/14/95, in the amount of
$8,750.00, which represents payment in support of the project entitled "Optical
Assessment of Hyperbilirubinemia in Neonates." This project is under the
direction of Xx. Xxxxxx X. Xxxxxxx of this Institution.
We are sincerely grateful for your financial assistance in support of this
project.
Sincerely,
/s/ Xxxxx X. Xxxxxxx
Xxxxx X. Xxxxxxx, CPA
Manager, Sponsored Programs
/jw
c: Xx. Xxxxxx X. Xxxxxxx
Xx. Xxxxxx xxx Xxxxxxxxxx
Xx. Xxxxxxx Xxxxxxxx