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EXHIBIT 10.13
CLINICAL RESEARCH STUDY AGREEMENT
This Agreement is entered into as of the 22 day of July, 1993, by and between
Emory University, located at 1462 Clifton Road, NE, Room 302, Atlanta, GA 30322
(hereinafter referred to as "UNIVERSITY"), and SpectRx, Inc., a Delaware
corporation, located at 6040C Unity Drive, Norcross, GA 30071 (hereinafter
referred to as "COMPANY").
BACKGROUND
The COMPANY has ongoing research in the area of using the fluorescence of lens
proteins and other tissues for the non-invasive diagnosis of disease. This
research has led to the issuance of U.S. Patent No. 5,203,328. The COMPANY has
one other patent application on file with two others in preparation for filing.
The COMPANY wishes to obtain from the UNIVERSITY an option to obtain certain
rights to inventions or discoveries that are developed solely by the UNIVERSITY
during the course of research funded by the COMPANY hereunder.
The COMPANY wishes to verify its hypothesis that certain fluorescence signals
are related to the glycosolation of lens proteins, advanced glycosolation end
products, screening for diabetes and measurement of Glycosolated Hemogolobins.
The COMPANY believes the UNIVERSITY to be capable of contributing to the
verification this hypotheses by the application of these techniques to human
patients according to the clinical study protocol provided by the COMPANY.
WITNESSETH THAT:
The UNIVERSITY agrees to conduct a clinical research study entitled "Clinical
Evaluation of a Non-Invasive Lens Measurement System for Detecting and
Monitoring Diabetes Mellitus" according to the protocol attached as Exhibit A.
In this undertaking, the UNIVERSITY agrees to devote its best efforts in order
to perform efficiently the work required under this Agreement. The UNIVERSITY
agrees that it will comply with all applicable laws, rules and regulations
relating to the conduct of such study, particularly such laws, rules and
regulations concerning or promulgated by the Food and Drug Administration. The
COMPANY will provide a prototype Lens Measurement System for the use in the
study. The SpectRx Lens Measurement System is not yet approved by the U.S. Food
and Drug Administration. To the extent any portions of Exhibit A are
inconsistent with this Agreement, the terms of this Agreement shall govern.
1. Principal Investigator
The study performed under this Agreement will be under the direction of
Dr. Dan Gallina (hereinafter "INVESTIGATOR").
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2. Human Subjects
This protocol has been approved by the UNIVERSITY's Institutional
Review Board (Exhibit B) and the COMPANY. The UNIVERSITY shall obtain
from each of the patients participating in this study, advanced
informed consent in compliance with 21 CFR 50.20 through 50.27 and any
modifications thereof as may be adopted. COMPANY will reimburse
UNIVERSITY and/or the patient for the reasonable costs and expenses
incurred in diagnosing and treating unanticipated adverse effects,
injuries, illnesses, or reactions that result from the use or
application of COMPANY's investigational drug or device in the course
of this study.
3. Indemnification
The "Indemnification Agreement for Clinical Study" is attached as
Exhibit C and is incorporated by reference.
4. UNIVERSITY and COMPANY Contacts
The UNIVERSITY's scientific contact for this Agreement will be Dr. Dan
Gallina at (404) 242-8723. The UNIVERSITY's administrative contact for
this Agreement will be Ms. Nancy Wilkerson at (404) 727-2503. The
COMPANY's scientific contact will be Mr. Jonathan Eppstein at (404)
242-8723. The COMPANY's administrative contact for the Agreement will
be Mr. Mark A. Samuels at (404) 242-8723.
5. Period of Performance
The term of this Agreement shall be from the date of this Agreement is
accepted until the study is either completed or terminated. It is
anticipated that the study will begin on July 19, 1993 and be completed
by March 1994.
6. Payment Schedule
A. Payments shall be made payable to EMORY UNIVERSITY and
forwarded to the following address:
Mr. William J. Mulcahy
Assistant Vice President for Finance
Office of Grants and Contracts Accounting
313 Administration Building
1380 South Oxford Road
Atlanta, GA 30322
(404) 727-4240
It is agreed that the COMPANY will reimburse the UNIVERSITY
for an amount not to exceed $99,960.00 in accordance with the
approved budget and payment schedule
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attached as Exhibit D. COMPANY acknowledges that the
UNIVERSITY has included its indirect costs for this clinical
study. For purposes of identification, payments will include
the title of the project and the name of the INVESTIGATOR.
B. In the event of termination, the sum for professional services
and expenses payable under this Agreement shall be limited to
the pro-rated fees based on actual work performed and actual
expenses committed pursuant to the protocol. Any unexpended
funds not due under this calculation but already paid shall be
returned to the COMPANY.
7. Independent Contractor
Each party to this Agreement shall act as an independent contractor and
shall not be construed for any purpose as the agent, employee, servant
or representative of the other party, and neither party shall enter
into any contract or agreement with a third party which purports to
obligate or bind the other party.
8. Publications
The UNIVERSITY shall have publication privileges in reference to the
subject study. In this regard, UNIVERSITY shall furnish COMPANY with a
copy of any proposed publication at least thirty (30) days in advance
of the proposed submission date. Within this thirty day period, COMPANY
shall review said proposed publication for technical content, including
patentable inventions, and for the disclosure of any proprietary
information which COMPANY may have furnished to facilitate the subject
study under this Agreement, and COMPANY shall inform UNIVERSITY in
writing of the location and content of specific proprietary information
contained in the proposed publication. Upon receiving the appropriate
written notification from COMPANY, UNIVERSITY shall edit the proposed
publication to remove COMPANY's proprietary information before
submission, and further, shall delete disclosure of potentially
patentable inventions, or delay submission for ninety (90) days until
the appropriate patent application can be filed. In the event COMPANY
does not respond to the submission within such time, approval will be
deemed to have been given.
The COMPANY shall also have publication privileges in reference to the
subject study. In this regard, COMPANY shall furnish UNIVERSITY with a
copy of any proposed publication at least thirty (30) days in advance
of the proposed submission date. Within this thirty day period,
UNIVERSITY shall review said proposed publication for technical
content, including patentable inventions, and for the disclosure of any
proprietary information which UNIVERSITY may have furnished to
facilitate the subject study under this Agreement. UNIVERSITY shall
inform COMPANY in writing of the location and content of specific
proprietary information contained in the proposed publication. Upon
receiving the appropriate written notification from UNIVERSITY, COMPANY
shall edit the proposed publication to remove UNIVERSITY's proprietary
information before submission, and further, shall delete disclosure of
potentially patentable inventions, or delay submission for ninety (90)
days until the appropriate patent
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application can be filed. In the event UNIVERSITY does not respond to
the submission within such time, approval will be deemed to have been
given.
9. Confidentiality
Subject to the provisions of Paragraph 8, the INVESTIGATOR agrees to
hold all information disclosed to it under this Agreement that the
COMPANY has advised the UNIVERSITY in writing is confidential for a
period of five (5) years from the date of termination of this Agreement
except,
A. Information that is now in the public domain or subsequently
enters the public domain through no fault of INVESTIGATOR or
UNIVERSITY;
B. Information that is presently known or becomes known to
INVESTIGATOR or UNIVERSITY from its own independent sources;
C. Information that INVESTIGATOR or UNIVERSITY receives from any
third party not under any confidential obligation to keep such
information confidential;
D. Information that is required to be disclosed by law.
10. Inventions and Patents Rights
A. It is expressly agreed that neither the COMPANY nor the
UNIVERSITY transfers by operation of this Agreement to the
other party any rights to any Invention, Discovery, or other
proprietary rights either party owns as of the commencement
date of this Agreement, except as specifically set forth
herein.
B. Ownership of Inventions and Discoveries: Any Invention or
Discovery made by COMPANY as a result of the clinical study
activities pertaining to this Agreement herein, if discovered
or developed solely by COMPANY personnel or based on the
results of the clinical study shall, from the time of
conception, be the property of the COMPANY. Any Invention or
Discovery made by UNIVERSITY during the clinical study
activities pertaining to this Agreement herein, if solely by
UNIVERSITY personnel and not based on the results of the
Clinical Study shall, from the time of conception, be the
property of the UNIVERSITY. Any Invention or Discovery made
jointly by both COMPANY and UNIVERSITY during the clinical
study activities pertaining to this Agreement herein and not
based on the results of the Clinical Study, if jointly
discovered or developed with associates from COMPANY and
UNIVERSITY personnel shall, from the time of conception, be
the joint property of both COMPANY and UNIVERSITY.
C. Jointly Owned Inventions or Discoveries: In the case of
jointly owned Inventions or Discoveries, COMPANY and
UNIVERSITY shall negotiate a sharing agreement suitable for
the management of such Invention or Discovery. Such sharing
agreement shall
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include, but not be limited to, revenue and expense sharing,
the party responsible for patent prosecution, the party
responsible for marketing, and the party responsible for
license negotiation.
D. Option and License Provisions: To the extent permitted by
existing UNIVERSITY policies and regulations, COMPANY shall be
given a ninety (90) day option to obtain a royalty- bearing,
world-wide, exclusive license to any patentable Invention or
Discovery made by the UNIVERSITY during the clinical study
activities pertaining to this Agreement and for which COMPANY
agrees to reimburse or pay the expenses of the patent
application. Such license agreement shall contain reasonable
terms based on industry standards in agreements relating to
similar products and technology, and any other relevant facts.
If at the expiration of such ninety (90) day period the
COMPANY has failed to exercise its option and execute a
license agreement, UNIVERSITY shall be free to offer an option
with respect to such Invention or Discovery to other third
parties.
The option for a license granted herein, and any resulting license
shall be subject to any agreement the UNIVERSITY may have or hereafter
enter with the Government, and to obligations to third parties existing
prior to the date of this Agreement. The UNIVERSITY warrants that it
has identified any such prior agreements in writing to the COMPANY
prior to entering into this agreement.
Notwithstanding any provision to the contrary in the Agreement, the
UNIVERSITY shall retain the right to practice any Invention or
Discovery developed hereunder for its own use.
11. Data Ownership
Any medical records generated under this Agreement shall be the
property of UNIVERSITY. COMPANY shall retain ownership of all completed
case medical record forms supplied by COMPANY and UNIVERSITY shall be
entitled to retain copies of the case medical record forms. UNIVERSITY
shall, within the bounds of legal requirements, make such medical
records available for review and copying by COMPANY.
UNIVERSITY shall be entitled to retain ownership of the data arising
out of this clinical study. Subject to paragraphs 8 and 10, COMPANY
shall have access to the data and may freely use such data in
connection with any of its research, development, marketing or
promotional activities and may be disclosed by the COMPANY to other
clinical investigators, consultants, the Food and Drug Administration
and other Federal, State and/or local regulatory agencies.
12. Publicity
COMPANY will not include the UNIVERSITY in any advertising, sales
promotion or other publicity matter without the prior written approval
of the UNIVERSITY. Likewise, the UNIVERSITY will not include the
COMPANY in any advertising, sales promotion or other publicity matter
without the prior written approval of the COMPANY.
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13. Termination
The study may be terminated prior to completion by written notice from
the COMPANY to the UNIVERSITY or by the UNIVERSITY to the COMPANY for
any of the following reasons:
A. Notification to the COMPANY from Federal or State Regulatory
Authorities to terminate said study;
B. Determination by the COMPANY or the UNIVERSITY that the
UNIVERSITY, after a reasonable opportunity, is unable for any
reason to perform the study satisfactorily as required in the
protocol;
C. Inability of the INVESTIGATOR to continue the study at the
UNIVERSITY and a successor acceptable to both UNIVERSITY and
COMPANY is not available.
Written notice of its decision to exercise such termination right shall
be given to the UNIVERSITY by the COMPANY or to the COMPANY by the
UNIVERSITY by Certified Mail, delivered fifteen (15) days before said
termination of the study.
Immediately upon receipt of a notice of termination by either the
COMPANY or the UNIVERSITY, the UNIVERSITY shall stop entering patients
into the study and shall cease conducting procedures, to the extent
medically permissible, on patients already entered into the
investigational protocol. In the event of termination, expenses payable
to the UNIVERSITY shall be stated in paragraph (6B).
Termination or completion of this Agreement, however, shall not relieve
the obligations undertaken by the parties in paragraphs 3, 8, 10, 12
and 13.
14. Modifications
Any alteration in or amendment to this Agreement must be approved in
writing by the UNIVERSITY and the COMPANY prior to such alteration or
amendment becoming effective.
Any modifications to the attached protocol must be agreed upon by
INVESTIGATOR and COMPANY and approved by UNIVERSITY's Institutional
Review Board.
15. Governing Law
This Agreement shall be governed by and construed in accordance with
the laws of the State of Georgia.
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16. Order of Precedence
The terms this Agreement shall take precedence over other documentation
in the interpretation and resolution of disputes concerning this study.
IN WITNESS WHEREOF, the parties have executed this Agreement on the day and year
first above written.
/s/ Mark A. Samuels /s/ Ann R. Stevens
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SpectRx, Inc. Emory University
By: Mark A. Samuels By: Ann R. Stevens, Ph.D.
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Title: Associate Vice President for Research
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