EXHIBIT 10.20
CLINICAL TRIAL AGREEMENT
Agreement made as of the first day of Jan, 1995, between The Tokyo Women's
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Medical College having a principal place of business at 8-1, Xxxxxx-Xxx,
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Xxxxxxxx-xx, Xxxxx 000, Xxxxx ("Medical College"), Kintomo Takakura, MD,
Professor and Chairman, Department of Neurosurgery, Neurological Institute,
Tokyo Women's Medical College, 0-0, Xxxxxx-Xxx Xxxxxxxx-xx, Xxxxx 000, Xxxxx
("Principal Investigator"), and Photoelectron Corporation, a corporation having
an office at 000-0 Xxxxxx Xxxx Xxxx, Xxxxxxx, Xxxxxxxxxxxxx, 00000 XXX
("Company").
1. The Principal Investigator agrees to participate as an investigator in a
clinical study of Model 3 Miniature X-ray Source of the Photon Radiosurgery
System (hereinafter referred to as the "Study Device") in accordance with the
multi-institution study protocol entitled "A Study of the Safety and Efficacy
of the Photon Radiosurgery System in the Treatment of Brain Metastases", a copy
of which is attached hereto as Exhibit A (hereinafter referred to as "Study").
In the event of any conflict between Exhibit A and the provisions of this
Agreement, the provisions of this Agreement shall govern. That portion of Study
that is carried out at Medical College is hereinafter referred to as
"Institutional Study". The Principal Investigator also agrees to adhere to the
Standard Operating Procedures for the Study as mandated by the FDA and to
operate and maintain the Study Device according to the instructions provided by
Company.
2. The Institutional Study will be conducted by the Principal Investigator at
Medical College with the prior approval and ongoing review of all appropriate
and necessary review authorities at Medical College and in accordance with all
Japanese laws and regulations. The Principal Investigator shall provide Company
with written evidence of review of the Study by the Medical College Ethics
Committee prior to the initiation of the Institutional Study and of the Ethics
Committee's continuing review and approval of the Institutional Study whenever
it is reviewed, but at least once per year. All volunteers will meet the legal
age requirements of Japan, the country in which the Institutional Study is to be
conducted.
3. Principal Investigator will furnish Company or its designated Study Monitor
with the data resulting from the Institutional Study in signed case report forms
within fourteen working days after the completion of each form and Company shall
have the unrestricted right to use such data including, but only to the extent
that subjects' consent have been obtained to use the subjects' names, any
identifying information, and any audiotapes,
photographs or other likenesses. The case report forms to be used will be those
supplied by Company. Patient records shall be made available to Company
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 both by
Company and by Medical College.
4. It is understood that this study is a multicentre investigation and a
publication of results from all sites is expected. After submission of
multicentre results for publication, or notification by Company that such a
submission is no longer planned, or twelve (12) months after termination of the
Study at all sites, whichever shall first occur the Principal Investigator shall
be free to publish the results of the Institutional Study subject only to the
provisions of Paragraph 7 regarding Company's confidential information. Company
will be furnished with a copy of any proposed publication for review and comment
prior to submission for publication, which for manuscripts, is at least thirty
(30) days prior to submission, and for abstracts, is at least seven (7) days
prior to submission. At the expiration of such a thirty (30) or seven (7) day
period, Principal Investigator may proceed with submission for publication.
5. In addition, since the Study is to be carried out at a number of
institutions, a minimum of one journal article describing the analyzed results
from all institutions will be submitted for publication at the conclusion of the
Study. Company will be responsible for coordinating the manuscript(s). Such
manuscript(s) will bear as authors, among others, all principal investigators of
the Study. The order of authors will be as follows: those who design and
implement the Study will be first; the principal investigator and other
individuals from the institution contributing the most patients will be listed
next; the principal investigator and other individuals at the institution
contributing the second largest number of patients will be next; and so on.
6. At the conclusion of Study and after such time as the multi-authored, multi-
institution journal article referred to in paragraph (5) has been published, all
principal investigators from all institutions participating in the Study who
have treated the number of anticipated patients with the Study Device as
described in paragraph 13, will be given complete access to all of the patient
data accrued in the Study, provided such access does not conflict with such laws
and practices as may be applicable. Access to data will not be provided in the
case of early termination of the Institutional Study.
7. In order to effectively complete the Institutional Study, it may be
necessary or desirable for the parties to disclose proprietary, trade secret
and/or other confidential information (herein "Confidential Information") to one
another. Each party agrees that any such Confidential Information disclosed to
it or to its employees shall be used only in connection with the legitimate
purposes of this Agreement; shall be safeguarded with the same care normally
afforded such Confidential Information in the possession, custody, or control of
the party receiving the Confidential Information provided, however, that the
disclosing party specifies in writing the nature and identity of the
Confidential Information and the manner and time of disclosure. The foregoing
shall not apply when,
after and to the extent the Confidential Information disclosed; i) becomes
generally available to the public through no fault of the receiving party;
ii) was already known to the receiving party at the time of disclosure as
evidenced by written records in the possession of the receiving party prior to
such time or; (iii) is subsequently received by the receiving party in good
faith from a third party without breaching any confidential obligation between
the third party and the disclosing party.
8. Medical College and Company agree that Company shall have an option to
acquire by assignment, at nominal expense to Company, all rights to each,
invention which constitutes a new use, or modification of the Study Device and
is made by Medical College personnel, solely or jointly, in the performance of
the Study (hereinafter referred to as "Invention"). Each Invention shall be
promptly reported in writing to Company and to Medical College, and Company
shall have ninety (90) days following receipt of such report to submit a written
request to Medical College to acquire rights to the reported Invention. In the
event Company so elects to acquire rights to an Invention, Medical College shall
promptly obtain from Medical College personnel appropriate assignments of all
rights in the Invention held by such personnel and thereafter shall assign all
its rights to Company.
9. This Agreement shall remain in force until the completion of Institutional
Study. Any party hereto shall have the right to terminate the Study and this
Agreement at any time upon thirty (30) days prior written notice thereof to the
other parties. The obligations of the parties under Paragraphs 2,3,4,5,6,7,8,
12,14,15,17,18 and 19 shall survive the termination of this
Agreement.
10. Company will provide the following equipment and other supplies to Medical
College: two Model 3 X-ray sources (each including internal radiation monitor),
a Control Box System, a 486DX Laptop Computer with applications software, colour
HP printer, photodiode array, probe straightener, external radiation monitor and
various clinical accessories, an ionization chamber, an electrometer with
computer interface, an IBM-compatible computer and a number of calibration
accessories, a dosimetry water tank with control electronics, applications
software, a radiochromic film reader, dosimetry phantoms and dosimetry
accessories (collectively, the "Equipment"). All Equipment provided by Company
will remain assets of Company. It is understood that Company will have access to
the Equipment at any time.
11. Company agrees to support this Institutional Study by: (a) providing the
Equipment for the duration of the Institutional Study at no charge to Medical
College (b) providing the Principal Investigator with information and
instruction pertaining to the Study Device and its operation as needed to
perform the Institutional Study; (c) repairing, maintaining, and modifying the
Study Device as needed during the Institutional Study; and (d) monitoring the
Institutional Study.
12. At the completion of the Institutional Study, the Equipment will be
returned to Company.
13. It is anticipated that Medical College will treat a minimum of ten
(10) eligible patients with the Study Device, per year, following the date of
this agreement. Failure to treat at least ten patients per year with the Study
Device may result in termination of the Institutional Study at Medical College
in accordance with paragraph 9.
14. It is understood that, in the interest of device integrity and patient
safety, the Study Device will be used for no purpose other than the
Institutional Study without the written permission of the Director of Clinical
Trials at Company. It is also understood that all maintenance of the equipment
listed in paragraph (10) must be carried out at Company, by Company personnel.
15. The covers and casings may not be removed from any of the Equipment by non-
Company personnel with the sole exception of the Control Box System which may be
opened for testing only in order to switch from manual to computer control of
the system. Adherence to this policy will both protect the interests of the
Company and ensure that all Study patients are treated with equipment that has
met the same standards.
16. The terms of this Agreement can be modified only by a writing which is
signed by Medical College, Principal Investigator and Company.
17. 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, sales literature, or publicity or in any non-
scientific publication without the prior written approval of the party or
individual whose name is to be used. For Medical College, such approval shall be
obtained from the Director of News and Public Affairs and for Company, from its
Chief Executive Officer.
18. Any notices to be delivered by either party to the others shall be
effective if delivered by registered mail, return receipt requested or by
facsimile transmission as follows: if to Medical College to __________________
_____________________________, if to Principal Investigator to Kintomo Takakura,
MD, Professor and Chairman, Department of Neurosurgery, Neurological Institute,
Tokyo Women's Xxxxxxx Xxxxxxx, 0-0, Xxxxxx-Xxx, Xxxxxxxx-Xx, Xxxxx 000, Xxxxx,
(fax: 00-0-0000-0000) if to Company to Xxxxxxxxx X. Xxxxx, PhD, Photoelectron
Corporation, 000-0 Xxxxxx Xxxx Xxxx, Xxxxxxx XX XXX 00000 (fax 000-000-0000).
19. The provisions of the 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.
PHOTOELECTRON CORPORATION THE TOKYO WOMEN'S MEDICAL COLLEGE
BY: /s/ Xxxxx Xxxxxxxxx BY: /s/ Xxxxxx Xxxxxx, M.D.
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XXXXX XXXXXXXXX, PH.D Xxxxxx Xxxxxx, M.D.
CHIEF OPERATING OFFICER Director of Tokyo Women's
Medical College Hospital
DATE: November 28, 1994
---------------------------- DATE: December 2, 1994
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PRINCIPAL INVESTIGATOR:
/s/ Kintomo Takakura, M.D.
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Kintomo Takakura, M.D.
DATE: December 1, 1994
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