EXHIBIT 10.17
CLINICAL TRIAL AGREEMENT
Agreement made as of the first day of August, 1992, between [*****] , a
not-for-profit corporation doing business as [*****], having a principal place
of business at [*****] ("[*****]"), [*****], M.D., Department of Neurosurgery,
[*****], [*****], [*****]("Principal Investigator") and Photoelectron
Corporation, a corporation having an office at ▇▇▇-▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Company").
1. Principal Investigator agrees to conduct a clinical study of
Miniaturized X-Ray Generator (hereinafter referred to as the "Study Device") in
accordance with the study protocol entitled "Investigational Plan for
Preliminary Trials of Model IXR-2 Photonic Radiosurgery Source", a copy of which
is 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.
2. The Study will be conducted by Principal Investigator at [*****] 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 Company with written evidence
of review and approval of this Study by [*****] 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 Company with the data resulting
from the Study in signed case report forms within a reasonable time after
completion of each case and Company shall have the unrestricted right to use
such data. Study 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 in conformance with applicable
federal regulations.
4. Principal Investigator will be free to publish the results of the Study
subject only to the provisions of Paragraph 5 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, 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
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such thirty (30) day or seven (7) day period, Principal Investigator may proceed
with submission for publication.
5. It is understood that [*****] cannot assure confidential treatment of
any information that may be disclosed to any [*****] staff member, employee or
student. In the event that Company wishes to disclose to any [*****] personnel
any information which relates to the Study that Company considers confidential,
Company may enter into a separate Confidentiality Agreement with such [*****]
personnel. Such Confidentiality Agreement must be approved as to form by the
Director, Office of Technology Affairs, [*****] and shall provide a means for
clearly identifying the information Company considers to be proprietary and not
abridge the traditional rights of [*****] or [*****] personnel to publish and
communicate with academic colleagues regarding the results of research conducted
at [XXXXX].
6. [*****] and Company agree that Company shall have an opportunity to
acquire by assignment all rights to each invention which constitutes a new use
or modification of the Study Device and is made by [*****] 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 [*****] and Company shall have ninety (90) days following receipt of
such report to submit a written request to [*****] to acquire rights to the
reported Invention. In the event Company so elects to acquire rights to an
Invention, [*****] shall promptly obtain from [*****] personnel appropriate
assignments of all rights in the Invention held by such personnel and thereafter
shall assign all its rights to Company.
7. The term of this Agreement shall be one (1) year from the date hereof.
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. In the event of termination, the amount of the reimbursement under
Paragraph 9(e) by Company 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. At the completion or early termination of the Study, an accounting will
be made of the clinical supplies provided for the Study by Company and any such
supplies remaining shall be returned to Company.
9. Company agrees to support this Study by: (a) providing a Study Device
to the Principal Investigator; (b) providing the Principal Investigator with
information and instruction pertaining to the Study Device and personnel to
operate the Study Device as needed to perform the Study; (c) repairing,
maintaining, and modifying the Study Device as needed during the Study; (d)
monitoring the Study; and (e) providing [XXXXX] with a research
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grant for one-half the salary of a nurse designated by [***] to assist
subjects participating in the Study for a period of one (1) year in the amount
of Thirty-Seven Thousand dollars ($37,000) which includes indirect costs in the
amount of Four Thousand Seven Hundred Seventy dollars ($4770), payable to
[XXXXX] as follows:
Eighteen Thousand Five Hundred Dollars ($18,500) upon execution of this
Agreement; and,
Eighteen Thousand Five Hundred Dollars ($18,500) on February 1, 1993.
Checks should be made payable to [***] 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:
[***]
10. (a) Company shall indemnify, defend and hold harmless [***] and its
trustees, officers, medical and professional staff, employees, and agents and
their respective successors, heirs and assigns (the "Indemnitees"), against any
liability, damage, loss, or expense (including reasonable attorney's fees and
expenses of litigation) incurred by or imposed upon the Indemnitees 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 and made
by Company or a licensee, affiliate or agent of Company; (ii) arising out of any
side effect or adverse reaction, illness or injury resulting from Indemnitees'
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 Indemnitees' performance of the Study. [***] agrees to notify Company
promptly of any such claim, suit, action, demand or judgment and [XXXXX] and
Principal Investigator agree to permit Company to control the defense and
disposition thereof (including, without limitation, all decisions to litigate,
settle or appeal) and further agree to reasonably cooperate with Company in the
handling thereof. Company agrees to keep [***] informed of the progress in the
defense and disposition of such claims and to consult with [***] with regard
to any settlement thereof which Company proposes to enter into.
(b) Company's indemnification under (a) above shall not apply to any
liability, damage, loss or expense to the extent that it is
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attributable to the: (i) negligent activities, reckless misconduct or
intentional misconduct of the Indemnitees; or (ii) failure of the Indemnitees to
adhere to the terms of the protocol for the Study.
(c) Company agrees, at its own expense, to provide attorneys reasonably
acceptable to the [XXXXXXX] 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.
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 Company or by a licensee, affiliate or agent of
Company, Company shall, at its sole cost and expense, procure and maintain
comprehensive general liability insurance in amounts not less than $2,000,000
per incident and $2,000,000 annual aggregate and naming the Indemnitees as
additional insureds, with respect to claims arising out of Indemnitees'
performance of, or involvement in, the Study, except those claims attributable
to (i) or (ii) of subparagraph 10(b) of this Agreement. Such comprehensive
general liability insurance shall provide (i) product liability coverage and
(ii) broad form contractual liability coverage for Company's indemnification
under Paragraph 10 of this Agreement. If Company 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 [XXXXXXX] 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 Company's
liability with respect to its indemnification under Paragraph 10 of this
Agreement.
(b) Company shall provide [XXXXXXX] with written evidence of such insurance
upon request of [XXXXXXX]. Company shall provide [XXXXXXX] with written notice
at least fifteen (15) days prior to the cancellation, non-renewal or material
change in such insurance.
(c) Company shall maintain such comprehensive 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 Company or by a licensee, affiliate or agent of Company
and (ii) a reasonable period after the period referred to in (c)(i) above which
in no event shall be less than five (5) years.
12. The terms of this Agreement can be modified only by a writing which is
signed by [XXXXXXX], Principal Investigator and Company.
13. No party to this Agreement shall use the name of any
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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 [XXXXXXX],
such approval shall be obtained from the Director of News and Public Affairs and
for Company, from its Chief Executive Officer.
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.
PHOTOELECTRON CORPORATION [XXX XXXXXXX XXXXXXXX XXXXXXXXXXX
XXXXXXXX XXX XX XXXX XXX XXX XXXX]
BY: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ BY: [XXXXXXXXXXXXXXXXXXXXXX]
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TITLE: President TITLE: Director,
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Office of Technology Affairs
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DATE: AUG __,1992 DATE: 7/31/92
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PRINCIPAL INVESTIGATOR
/s/ [XXXXXXXX XX XXXXXXX XXXX]
--------------------------------------
[XXXXXXXX XX XXXXXXX XXXX]
DATE: 9/10/92
---------------------------------
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AMENDMENT TO CLINICAL TRIAL
AGREEMENT EFFECTIVE AUGUST 1, 1992
BETWEEN PHOTOELECTRON CORPORATION, [XXX XXXXXXX
XXXXXXXX XXXXXXXXXXX AND XXXXXXXX XX XXXXXX], M.D.
Effective August 1, 1993, [XXX XXXXXXX XXXXXXXX XXXXXXXXXXX], a not-for-
profit corporation doing business as [XXXXXXXXXXXXX XXXXXXX XXXXXXXX], having
its principal place of business at [XXXXX XXXXXX], Boston, MA [XXXXX
("XXXXXXX")], [XXXXXXXX XX XXXXXX], M.D., Department of Neurosurgery,
[XXXXXXXXXXXXX XXXXXXX XXXXXXXX], Boston, MA [XXXXX] ("Principal Investigator")
and Photoelectron Corporation, a corporation having an office at ▇▇▇-▇ ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Company") agree, for good and valuable
consideration to amend the Clinical Trial Agreement effective August 1, 1992
("Agreement") as follows:
1. In Paragraph 1 of the Agreement, the words "Model IXR-2 and Model ▇▇▇▇
2 of the" shall be inserted after the words "clinical study of".
2. In paragraph 1 of the Agreement, the following words shall be added as
the last sentence: "The parties agree that the Study shall also include the use
of the Study Device by the Principal Investigator for the treatment and follow-
up of not more than ten (10) additional patients on a compassionate use basis."
3. In paragraph 7 of the Agreement, the words "one (1) year from the date
hereof" shall be replaced with the words "until the execution of a clinical
trial agreement between [XXXXXXX], Company and Principal Investigator for a
Phase II trial of the Study Device, or for two (2) years from the date hereof,
whichever shall first occur."
4. Beginning with the Effective Date of this Amendment, Company shall
provide [XXXXXXX] with a research grant for one-half the salary of a nurse
designated by [XXXXXXX] to assist subjects participating in the Study which
shall be payable as monthly payments of Three Thousand Eighty-Three Dollars and
Thirty-Three Cents ($3,083.33) per month for the term of the Agreement (as such
term is amended pursuant to the immediately foregoing paragraph 3 of this
Amendment).
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IN WITNESS WHEREOF, the parties have caused this Amendment to the Agreement
to be duly executed.
PHOTOELECTRON CORPORATION [XXX XXXXXXX XXXXXXXX XXXXXXXXXXX]
BY: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ BY: [XXXXXXX XXXX XXX]
--------------------------------- --------------------------------
TITLE: President & CEO TITLE: Director, Office of
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Technology Affairs
DATE: Nov. 12, 1993 DATE: 11/8/93
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PRINCIPAL INVESTIGATOR
/s/ [XXXXXXXX XX XXXXXX], M.D.
-----------------------------------
[XXXXXXXX XX XXXXXX], M.D.
DATE: [DATE APPEARS HERE]
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