EXHIBIT 10.15 TO FORM 10-KSB FOR FISCAL YEAR ENDING DECEMBER 31, 1996
SPECTRASCIENCE, INC
CLINICAL RESEARCH AGREEMENT
Agreement made this first day of June, 1995, ("Effective Date") between
The General Hospital Corporation, a not-for-profit corporation doing business as
Massachusetts General Hospital, having a principal place of business at Xxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000 ("General") and SpectraScience, Inc., a
corporation having an office at 0000 Xxxxx Xxxx, Xxxxx 000. Xxxxxxxxxx, XX 00000
("SpectraScience").
1. For the purposes of this Agreement, the following terms shall have
the following meanings:
(a) "Invention" shall mean any invention which constitutes a new use of
or modification to the Study Device which any Investigator, solely or jointly,
conceives and reduces to practice in the performance of the Study.
(b) "Investigator" shall mean the Principal Investigator together with
other General professional staff members, students, research fellows, and
employees who perform the Study under his or her direction.
(c) "Study" shall mean the scientific research described in the
research protocol (s) attached hereto as Exhibit A on the Effective Date or
thereafter appended hereto pursuant to paragraph 2(b) below and funded by
SpectraScience and performed by the Investigators.
(d) "Study Device" shall mean the Spectroscopic Guidewire System
(comprised of the Spectroscopic Diagnostics System console, proprietary system
software, and the disposable optical core Spectroscopic Guidewire) provided by
SpectraScience for the Study at General.
2. (a) General, through a Principal Investigator, agrees to conduct
clinical research of the Study Device in accordance with the study protocol (s)
attached hereto as Exhibit A (hereinafter referred to as the "Study"). In the
event of any conflict between Exhibit A and the provisions of this Agreement,
the provisions of this Agreement shall govern.
(b) At any time during the term of this Agreement either party may
propose in writing additional research pertaining to the Study Device not
previously described in any research protocol appended hereto as Exhibit A. Each
such protocol shall name the individual at General who will be the Principal
Investigator and shall include a description of the additional research proposed
and a budget of the costs to be funded by SpectraScience and a schedule of
payment of such costs. Unless the parties shall otherwise agree in writing,
negotiations between them over any such protocol shall not extend beyond the
sixtieth (60) day next following the date when the protocol shall have first
been proposed, and whenever such negotiations shall end without agreement
between the parties to proceed with the proposed research, the party proposing
the additional research may go ahead without the other party and seek funding
from any other sponsor including but not limited to a commercial sponsor for
such protocol. When such protocol is accepted by General and SpectraScience, the
Principal Investigator shall, when necessary under the applicable regulations,
submit such protocol to the General's IRB and , if approved, it shall be
appended hereto as a Study and shall be subject to the terms and conditions of
this Agreement unless otherwise specified, and the research described therein
shall commence and budgeted amounts shall be paid as set forth in the protocol
or as otherwise agreed by the parties in writing.
(c) The Study will be conducted by a Principal Investigator at General
with the prior approval and ongoing review of all appropriate and necessary
review authorities and in accordance with all federal, state and local laws and
regulations. Principal Investigator shall provide SpectraScience with written
evidence of review and approval of the Study by General's Institutional Review
Board prior to the initiation of the Study and of the Board's continuing review
and approval of the Study whenever it is reviewed, but at least once per year.
All volunteers will meet the legal age requirements of the Commonwealth of
Massachusetts, the state in which the Study is to be conducted.
3. Principal Investigator will furnish SpectraScience with the data
resulting from the Study in signed case report forms within a reasonable time
after completion of each case and SpectraScience shall have the unrestricted
right to use such data including, but only to the extent that subjects' consents
have been obtained, the subjects' names, any identifying information, and any
audiotapes, photographs or other likenesses. Study records shall be made
available to SpectraScience representatives upon request for comparison with
case report forms. Such records will also be made available upon request for
review by representatives of the U.S. Food and Drug Administration. Records of
the Study including either the original or a copy of all volunteer consent forms
shall be retained in conformance with applicable federal regulations.
SpectraScience shall notify Principal Investigator of the date a premarket
approval application (PMA) is approved for the device; or if the application is
not approved, SpectraScience shall notify Principal Investigator when all
clinical investigations have been discontinued and the FDA notified.
4. Principal Investigator will be free to publish the results of the
Study subject only to the provisions of Paragraph 5 regarding SpectraScience's
proprietary information. SpectraScience will be furnished with a copy of any
proposed publication for review and comment prior to submission for publication,
for manuscripts, at least thirty (30) days prior to submission, and for
abstracts, at least seven (7) days prior to submission. At the expiration of
such thirty (30) day or seven (7) day period, Principal Investigator may proceed
with submission for publication.
5. In the event that SpectraScience discloses to any General personnel
any information which relates to the Study that SpectraScience considers
confidential, the rights and obligations of the parties with respect to such
information shall be governed by the terms and conditions set forth in Exhibit
B.
6. The Principal Investigator and any other Investigator who shall make
an Invention, solely or jointly, shall promptly report such Invention to General
and shall assign all of his or her rights, title and interest in the Invention
to General. General shall promptly advise SpectraScience in writing of each
Invention disclosed to General and shall discuss with SpectraScience whether a
patent application or applications (hereinafter referred to, together with any
patents issued thereon, as "Patent Rights") pertaining to such Invention should
be filed and in which countries. In the event of joint inventorship between
SpectraScience personnel and General Investigators, SpectraScience personnel
shall assign all of their rights, title and interest in the Invention to
SpectraScience, and General Investigators shall assign all of their rights,
title and interest in the Invention to General, and the Invention will be deemed
to be jointly owned. If both parties mutually agree that Patent Rights should be
filed, applications assigned solely to General shall be filed by General, and
applications owned jointly by General and SpectraScience shall be filed as
mutually agreed upon by the parties. In the event SpectraScience is not
interested in having Patent Rights filed with respect to a particular Invention,
SpectraScience shall advise General of such fact within ninety (90) days from
the date on which the Invention was disclosed to SpectraScience by General and
General shall be free to file and prosecute Patent Rights on such Invention at
its own expense and to license such Patent Rights to any other party.
All information given to SpectraScience by General in accordance with
this paragraph 6 will be held in confidence by SpectraScience so long as such
information remains unpublished or publicly undisclosed by General
All patent costs pertaining to any Patent Rights filed by mutual
agreement of SpectraScience and General, including preparation, filing,
prosecution, issuance and maintenance costs, shall be borne by SpectraScience.
As to any Patent Rights assigned in whole or in part to General and
filed by mutual agreement of the parties, to the extent not prohibited by the
United States Government or prevented by the obligations of General to any other
sponsor of research at General, SpectraScience shall have for the twelve (12)
months next following the filing of such Patent Rights in the United States
Patent and Trademark Office the option to obtain a world-wide, royalty bearing,
exclusive license under General's rights therein with the right to sublicense.
In the event that General is prohibited or prevented as aforesaid from granting
an exclusive license to any Patent Right hereunder, General will grant to
SpectraScience the most exclusive license that it is able to grant to
SpectraScience. The option is to be exercised by written notice to General
during said twelve month period and the negotiation of a license agreement
containing license terms standard for agreements between universities and
industry including without limitation clauses providing for payment of
reasonable royalties to General, objective, time-limited due diligence
provisions for the development, commercialization and marketing of a product
embodying the Invention and product liability indemnification and insurance
requirements which are acceptable to General's liability insurance carrier. In
the absence of such notice by SpectraScience and Agreement on license terms,
General may grant a license to such Patent Rights to any other party.
7. The term of this Agreement shall be two (2) years from the Effective
Date. Any party hereto shall have the right to terminate this Agreement at any
time upon thirty (30) days prior written notice thereof to the other parties. In
the event of termination, the amount of the research grant by SpectraScience to
support the Study shall be appropriately prorated. The obligations of the
parties under Paragraphs 3,4,5,6,8,10,11 and 13 shall survive the termination of
this Agreement.
8. SpectraScience shall provide, install and maintain, without cost to
General, the Study Device to General to conduct the Study. The Study Device
shall remain the property of SpectraScience.
9. In consideration of said undertaking by General, SpectraScience
agrees to support the Study with research grants to General in accordance with
the budgets included in the research protocol appended as Exhibit A. Such
research grants shall include indirect costs computed at a rate of 28% of total
direct costs payable to General.
Checks should be made payable "The General Hospital Corporation" and
sent, along with a letter indicating the name of the Principal Investigator and
the specific clinical trial agreement for which the funds are intended, to:
Director
Office of Technology Affairs
Massachusetts General Hospital
Thirteenth Street, Building 149, Suite 1101
Xxxxxxxxxxx, XX 00000
10. (a) SpectraScience shall indemnity, defend and hold harmless
General and its trustees, officers, medical and professional staff, employees,
and agents and their respective successors, heirs and assigns (the
"Indemnities"), against any liability, damage, loss, or expense (including
reasonable attorney's fees and expenses of litigation) incurred by or imposed
upon the Indemnities or any one of them in connection with any claims, suits,
actions, demands or judgments: (i) arising out of any theory of product
liability (including, but not limited to, actions in the form of tort, warranty,
or strict liability) concerning the Study Device or any modification thereof
developed pursuant to this Agreement; (ii) arising out of any side effect or
adverse reaction, illness or injury resulting from Indemnities' performance of
the Study and occurring to any person involved in the Study; or (iii) arising
out of damage to any property resulting from and occurring during the
Indemnities' performance of the Study. General agrees to notify SpectraScience
promptly of any such claim, suit, action, demand or judgment and General and
Principal Investigator agree to reasonably cooperate with SpectraScience in the
handling thereof.
(b) SpectraScience's indemnification under (a) above shall not apply to
any liability, damage, loss or expense to the extent that it is attributable to
the: (i) negligent activities, reckless misconduct or intentional misconduct of
the Indemnities; or (ii) failure of the indemnities to adhere to the terms or
the protocol for the Study
(c) SpectraScience agrees, at its own expense, to provide attorneys
reasonably acceptable to the General to defend against any actions brought or
filed against any party indemnified hereunder with respect to the subject of
indemnity contained herein, whether or not such actions are rightfully brought.
(d) SpectraScience also agrees to reimburse General for the costs of
the care and treatment of any illness or injury to a subject resulting from his
or her participation in the Study to the extent that such costs are not covered
by the subject's medical or hospital insurance or governmental programs
providing such coverage.
11. (a) At such time as the Study Device or any modification thereof is
being commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by SpectraScience or by a licensee, affiliate or agent of
SpectraScience, SpectraScience shall, at its sole cost and expense, procure and
maintain commercial general liability insurance in amounts not less than
$2,000,000 per incident and $2,000,000 annual aggregate and naming the
Indemnities as additional insureds. Such commercial general liability insurance
shall provide (i) product liability coverage and (ii) broad form contractual
liability coverage for SpectraScience's' indemnification under Paragraph 10 of
this Agreement. If SpectraScience elects to self-insure all or part of the
limits described above (including deductibles or retentions which are in excess
of $250,000 annual aggregate) such self-insurance program must be acceptable to
the General and the Risk Management Foundation of the Harvard Medical
Institutions, Inc. The minimum amounts of insurance coverage required under this
Paragraph 11 shall not be construed to create a limit of SpectraScience's
liability with respect to its indemnification under Paragraph 10 of this
Agreement.
(b) SpectraScience shall provide General with written evidence of such
insurance upon request of General. SpectraScience shall provide General with
written notice at least fifteen (15) days prior to the cancellation, non-renewal
or material change in such insurance.
(c) SpectraScience shall maintain such commercial general liability
insurance during (i) the period that the Study Device or any modification
thereof is being commercially distributed or sold (other than for the purpose of
obtaining regulatory approvals) by SpectraScience or by a licensee, affiliate or
agent of SpectraScience and (ii) a reasonable period after the period referred
to in (c) (i) above which in no event shall be less that fifteen (15) years.
12. The terms of this Agreement can be modified only by a writing which
is signed by General, Principal Investigator and SpectraScience.
13. No party to this Agreement shall use the name of any other party or
of any staff member, employee or student of any other party or any adaptation
thereof in any advertising, promotional or sales literature or in any publicity
without the prior written approval of the party or individual whose name is to
be used. For General, such approval shall be obtained from the Director of
Public Affairs.
14. The provisions of this Agreement shall be interpreted under the
laws of the Commonwealth of Massachusetts.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed as of the day and year first above written.
SPECTRASCIENCE, INC. THE GENERAL HOSPITAL CORPORATION
(Federal Tax ID No. : 042 697 983)
BY: /s/ Xxxxx X. XxXxxxx BY:
TITLE: Xxxxx X. XxXxxxx TITLE: Vice President for Patents,
President & CEO Licensing and Industry
Sponsored Research
DATE: 5/31/95 DATE: 6/6/95
Exhibit A
STUDY PROTOCOLS
The parties agree that the attached protocol entitled "Optical
Diagnostic Techniques for GI Endoscopy" is a Study protocol under the Agreement.
The study will be conducted under the direction of Xxxxxx Xxxxxxxx, M.D.
("Principal Investigator") at General.
Pursuant to paragraph 9 of the Agreement, SpectraScience agrees to
provide payment to General in the amount of One Hundred Ninety-Nine Thousand
Eight Hundred and Fifty Dollars ($199,850) which includes indirect costs in the
amount of Forty-Three Thousand Seven Hundred Seventeen Dollars ($43,717) for the
first year of the Study. Such grant shall be payable as follows:
Forty-Nine Thousand Nine Hundred Sixty-Two Dollars and Fifty Cents
($49,962.50) upon execution of the Agreement;
Forty-Nine Thousand Nine Hundred Sixty-Two Dollars and Fifty Cents
($49,962.50) on or about September 1, 1995;
Forty-Nine Thousand Nine Hundred Sixty Two Dollars and Fifty Cents
($49,962.50) on or about December 1, 1995; and,
Forty-Nine Thousand Nine Hundred Sixty-Two Dollars and Fifty Cents
($49,962.50) on or about March 1, 1996.
The parties agree that the Study may continue for two (2) years and
further agree that the second year of the Study will not be initiated until the
parties have agreed in writing to the amount of funding to be provided by
SpectraScience.
Checks should be made payable to "The General Hospital Corporation" and
sent, along with a letter indicating the name of the Principal Investigator and
the specific clinical trial agreement for which the funds are intended, to:
Director
Office of Technology Affairs
Massachusetts General Hospital
Thirteenth Street, Building 149, Suite 1101
Xxxxxxxxxxx, XX 00000
I have read the Agreement and agree to comply with the obligations of the
Principal Investigator stated therein. In addition, I have read Exhibit B and
agree to comply with the obligations of General stated therein.
/s/ Xxxxxx Xxxxxxxx, M.D.
Name: Xxxxxx Xxxxxxxx, M.D.
Date: 6/9/95
Exhibit A
Optical Diagnostic Techniques for GI Endoscopy
MASSACHUSETTS GENERAL HOSPITAL - SPECTRASCIENCE
COLLABORATIVE RESEARCH PROJECT TO DEVELOP NOVEL
OPTICAL DIAGNOSTIC METHODS
STATEMENT OF WORK
Under this research agreement, Xx. Xxxxxxxx'x research group at the
Massachusetts General Hospital will perform investigations aimed at developing
optical diagnostic capabilities to augment gastrointestinal endoscopy. Whenever
possible, the program will seek to develop optical methods for tissue diagnosis
without the use of exogenous dyes or markers. Because previous research has
indicated that tissue optical signals are very sensitive to metabolic
conditions, the most reliable data are those obtained from living tissue. For
this reason, the proposed research program will make extensive use of optical
measurements from clinical subjects (in vivo). In the first year, the main focus
of the investigations will be the detection of neoplasia in several settings
including the determination of neoplasia in polyps (hyperplastic vs. adenomatous
polyps) and the location of "flat"dysplasia (e.g. ulcerative colitis and
Xxxxxxx'x esophagus). Whenever possible the techniques developed in the course
of this work will be tested in other organ systems (specifically, skin, bladder
and gynecology) to test the general applicability of the techniques. The initial
optical techniques to be examined will be laser-induced fluorescence emission
spectroscopy, fluorescence excitation spectroscopy and reflectance spectroscopy.
Based on data obtained from clinical subjects, we plan to use statistical
methods to develop algorithms capable of making reliable discriminations between
tissue types. Although preliminary, recent measurements by us suggest that
wavelengths outside the visible range might provide enhanced diagnostic
accuracy. In the gastrointestinal tract, it is anticipated that specialized
devices will be needed to make optical measurements of high quality that can be
accurately correlated with tissue histology. The development of such devices
will be guided by MGH investigators but will require the expertise of
SpectraScience for design and fabrication.
In the second year, work on the optical techniques developed in year
one will continue and the application of the most promising techniques to other
organ systems will be examined in a systematic fashion. Studies examining the
feasibility of using optical techniques to enhance diagnostic accuracy in
non-neoplastic lesions of the gastrointestinal tract will also be started.
Specifically, the use of optical techniques to predict the risk of recurrent
bleeding from ulcers and the presence of Helicobacter pylori infection in the
gastric antrum will be examined.
FACILITIES
Xxxxxxx Laboratories
Xxxxxxx Laboratories of Photomedicine occupies 23,000 square feet on
the main campus of MGH. The majority of this space was specifically designed for
laser biology research. All Xxxxxxx facilities will be available for this work.
Only equipment most germane to the proposed research is described. Two portable
laser-induced fluorescence systems are available for diagnostic use. The systems
employ a fiber-optic pulsed nitrogen laser and an intensified optical
multi-channel analyzer capable of gating to 10 ns. Several filtered-flash,
filtered CCD cameras interfaced to personal computers are available for
fluorescence and non-fluorescence image acquisition and analysis. A portable
fiber-optic coupled reflectance spectrometer is also available. For in vitro
measurements, a UV/VIS/NIR spectrophotometer, a diode-array spectrophotometer, a
spectrofluorometer/phosphorimeter system, complete tissue culture facilities,
two high-performance liquid chromatographs and a cold room are available. The
photopathology laboratory is able to process specimens for routine light
microscopy, frozen sections, immunohistrochemistry, special stains, computerized
image analysis, transmission and scanning electron microscopy. For analysis of
light microscopic samples, there is a PC-based imaging system. Images can be
input to a computer utilizing a Newvicon tube camera attached to a microscope
for routine bright field examination or a SIT camera for low intensity images
such as fluorescence examination. The electron microscopy facilities include a
Xxxxxxxx XX-10 transmission electron microscope, Xxxxxxxx Ultracut E
ultramicrotome, critical point and sputter coater. There is access to an Amray
1400 scanning electron microscope in an adjacent laboratory.
Medical Endoscopy Unit
The Medical Endoscopy Unit at MGH is fully-equipped with state-of-the
art gastrointestinal endoscopy equipment manufactured by Olympus and Pentax. All
procedures are performed with the capability of digitally capturing and storing
images for later retrieval, printing or analysis. The unit performs close to
5,000 endoscopic procedures per year.
weeks 5/10/95
INVESTIGATOR: Xxxx Xxxxxxxx, M.D.
TITLE OF STUDY: Optical Diagnostic Techniques for GI Endoscopy
SPONSOR: SpectraScience
BUDGET PERIOD: 06/01/95 - 05/31/96
PERSONNEL
Role in % Base Fringe
Name Project Effort Salary Salary Benefits Total
26.04%
Xxxx Xxxxxxxx, M.D. P.I. 25% $82,915 $20,729 5,398 $26,127
Xxxxx Xxxxxxxxxx, Ph.D. Investigator 35% $46,782 $16,374 4,264 $20,637
Postdoctoral Fellow, TBN 100% $30,000 $30,000 7,812 $37,812
Clinical Fellow, TBN 50% $35,000 $17,500 4,557 $22,057
Subtotal: $106,633
EQUIPMENT
Computer 6,000
Compact Ex/Em Spectrometer (SPEX) 28,000
SUPPLIES
Fibers, optical components, software
8,000
TRAVEL
To attend ASLMS, SPIE and DIG DIS week 6,000
MISCELLANEOUS COSTS
Publication Costs 1,500
TOTAL DIRECT COSTS 156,133
INDIRECT COSTS (28%) 43,717
TOTAL COSTS $199,850
/s/ Xxxxxx X. Xxxxx
Xxxxxx X. Xxxxx, Manager, Pre-Award
Grant/Contract Administration
Reused 5/12/95
Exhibit B
SPECTRASCIENCE PROPRIETARY INFORMATION
It is anticipated that in the performance of the Study Sponsored by
SpectraScience, the Principal Investigator and members of the research team
designated by him/her will be provided with or given access by SpectraScience to
certain information which the SpectraScience considers proprietary. The rights
and obligations of the parties with respect to such information are as follows:
1. PROPRIETARY INFORMATION. For the purposes of this Agreement,
"Proprietary Information" refers to information of any kind which is
disclosed by SpectraScience to General and which, by appropriate
marking, is identified as confidential and proprietary at the time of
disclosure. In the event that proprietary information must be provided
visually or orally, obligations or confidence shall attach only to that
information which is confirmed by SpectraScience in writing within ten
(10) working days as being confidential.
2. LIMITATIONS ON USE. General shall use the SpectraScience's Proprietary
Information solely for the purposes of the conducting the Study,
obtaining any required review of the Study or its conduct, or ensuring
proper medical treatment of any patient or subject. It is agreed by
SpectraScience and General that the transfer of Proprietary Information
shall not be construed as a grant of any right or license with respect
to the information delivered except as set forth herein or in a duly
executed license agreement.
3. CARE OF PROPRIETARY INFORMATION . The SpectraScience and General agree
that all Proprietary Information communicated by SpectraScience and
accepted by General in connection with this Agreement shall be kept
confidential by General as provided herein unless specific written
release is obtained from SpectraScience. General agrees to exert
reasonable efforts (no less than the protection given its own
confidential information) to maintain such Proprietary Information in
confidence, to make such Proprietary Information available only to
those employees and students who require access to it in the
performance of this Agreement and to inform them of the confidential
nature of such information.
General shall be deemed to have discharged its obligations hereunder
provided General has exercised the foregoing degree of care and
provided further that General shall immediately, upon discovery of any
disclosure not authorized hereunder, notify SpectraScience and take
reasonable steps to prevent any further disclosure or unauthorized use.
When the Proprietary Information is no longer required for the purpose
of this Agreement, General shall return it or dispose of is as directed
by the SpectraScience. General's obligations of confidentiality with
respect to Proprietary Information provided under this Agreement will
expire five (5) years after the date of this Agreement.
4. INFORMATION NOT COVERED. It is agreed by SpectraScience and General
that information shall not be deemed Proprietary Information in the
event:
(a) it is publicly available prior to the date of the Agreement or
becomes publicly available thereafter through no wrongful act of
General;
(b) it was known to General prior to the date of disclosure or becomes
known to General thereafter from a third party having an apparent bona
fide right to disclose the information;
(c) it is disclosed by General in accordance with the terms of the
SpectraScience's prior written approval;
(d) it is disclosed by SpectraScience without restriction on further
disclosure;
(e) it is independently developed by General; or
(f) General is obligated to produce pursuant to an order of a court of
competent jurisdiction or a valid administrative or Congressional
subpoena, provided that General (a) promptly notifies the
SpectraScience and (b) cooperates reasonably with the SpectraScience's
efforts to contest or limit the scope of such order
