EXHIBIT 10.18
INVESTIGATIONAL TREATMENT AGREEMENT
Agreement made as of the first day of September, 1994 (the "Effective
Date") between [XXX XXXXXXX XXXXXXXX XXXXXXXXXXX], a not-for-profit corporation
doing business as [XXXXXXXXXXXXX XXXXXXX XXXXXXXX] having a principal place of
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business at [XXXXX XXXXXX], Boston, Massachusetts [XXXXX ("XXXXXXX"), XXXX X.
XXXXXXXX], M.D., Department of Neurosurgery, [XXXXXXXXXXXXX XXXXXXX XXXXXXXX],
Boston, Massachusetts [XXXXX] ("Principal Investigator") and Photoelectron
Corporation, a corporation having an office at 000-0 Xxxxxx Xxxx Xxxx, Xxxxxxx,
Xxxxxxxxxxxxx 00000 ("Company").
1. Principal Investigator agrees to participate as an investigator in an
investigational treatment study of Model 3 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 the "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 [XXXXXXX] 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 Principal Investigator at
[XXXXXXX] 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 [XXXXXXX] Institutional Review
Board prior to the initiation of the Institutional 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 or its designated Study
Monitor with the data resulting from the Institutional Study in signed case
report forms within a reasonable time after completion of each form and Company
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.
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
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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. It is understood that this Study is a multicentre investigation and
that a publication of results from all sites is expected to be made in
accordance with paragraph 5. After submission of the multicenter results for
publication, 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 will 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, 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. 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.
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; 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 the Study and after such time as a minimum of one
multi-authored, multi-institution journal article has been published, all
Principal Investigators from all institutions participating in the Study who
have treated with the Study Device the number of anticipated patients as
described in paragraph 15 will be given complete access to all of the patient
data accrued in the Study.
7. It is understood that [XXXXXXX] cannot assure confidential treatment of
any information that may be disclosed to any [XXXXXXX] staff member, employee or
student. However, the Principal Investigator agrees that, for a period of five
(5) years from the Effective Date of this Agreement, the Principal Investigator
will not disclose to any third party information which the Principal
Investigator receives from Company which is in writing and designated as
confidential or, if disclosed orally, is designated as confidential at the time
of disclosure and confirmed in writing as confidential within twenty-one (21)
days of such disclosure, or use such information for any purpose other than the
purpose of
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conducting the Study, obtaining any required review of the Study or its conduct,
or in the sound judgment of Principal Investigator, ensuring proper medical
treatment of any patient or subject. Such information shall not be considered
confidential nor subject to this Agreement if it: (i) was in Principal
Investigator's possession prior to receipt thereof from Company as shown by
written records; (ii) is already available or becomes available to the public
through no fault of Principal Investigator; (iii) was received by Principal
Investigator from a third party having a right to disclose it; (iv) is developed
by or on behalf of Principal Investigator; or (v) was ordered disclosed as a
matter of law.
8. [XXXXXXX] 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 [XXXXXXX] personnel, solely
or jointly, in the performance of the Institutional Study (hereinafter referred
to as "Invention"). Each Invention shall be promptly reported in writing to
Company and to [XXXXXXX], and Company shall have ninety (90) days following
receipt of such report to submit a written request to [XXXXXXX] to acquire
rights to the reported Invention. In the event Company so elects to acquire
rights to an Invention, [XXXXXXX] shall promptly obtain from [XXXXXXX] 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 have an initial term of two (2) years from the
Effective Date and thereafter the term of this Agreement shall automatically
renew for additional one (1) year periods until such time as one party notifies
the other parties in writing at least thirty (30) days prior to the anniversary
of the Effective Date that the Agreement should not be renewed. Any party hereto
shall have the right to terminate the Institutional 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 3,4,5,6,7,8,
12,13,14,17,18 and 20 shall survive the termination of this Agreement.
10. Company will provide the following equipment and other supplies to
[XXXXXXX]: 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, and 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"). The parties
acknowledge that at the time of execution of this Agreement the price of the
Equipment, with Warranty and Service Contract, is approximately $544,400.
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11. Company agrees to support this Institutional Study by: (a) providing a
Study Device including all Equipment listed in paragraph 10 above at no charge
to [XXXXXXX]; (b) providing the Principal Investigator with information and
instruction pertaining to the Study Device and its operation as needed to
perform the Study; (c) repairing, maintaining, and modifying the Study Device as
needed during the Institutional Study; (d) monitoring the Institutional Study;
and (e) providing [XXXXXXX] with a research grant for one-half the salary of a
nurse/coordinator designated by [XXXXXXX] for the term of this Agreement. The
responsibilities of the nurse/coordinator will include overseeing the collection
and assembly of data generated by the Institutional Study, frequent
correspondence with the Study Monitor, scheduling of patient visits, and
supervision of the follow-up of each patient by shepherding patients through
their visits with various physicians and to different diagnostic procedures.
Payment to [XXXXXXX] for one-half the salary of the nurse/coordinator in the
amount of $51,538.87 per year, which includes salary of $33,290.40, fringe
benefits (20.95%) in the amount of $6974.34 and indirect costs (28%) in the
amount of $11,274.13. Payment will be made in equal quarterly payments in the
amount of $12,884.72.
The checks should be made payable to "[XXX XXXXXXX XXXXXXXX XXXXXXXXXXX]"
and sent, along with a letter indicating the name of the Principal Investigator
and the specific agreement for which the funds are intended, to:
[XXXXXXXX]
[XXXXXX XX XXXXXXXXXX XXXXXXX]
[XXXXXXXXXXXXX XXXXXXX XXXXXXXX]
[XXXXXXXXXX XXXXXX, XXXXXXXX XXX, XXXXX XXXX]
[XXXXXXXXXXX, XX XXXXX]
12. At the completion of enrollment and treatment of twenty-five (25)
patients with the Study Device in the Institutional Study, all Equipment listed
in paragraph 10 above will become assets of [XXXXXXX].
13. In the event the Institutional Study is terminated early (prior to the
treatment of twenty-five (25) Institutional Study patients with the Study
Device), an accounting will be made of the Equipment provided for the
Institutional Study by Company and any such Equipment remaining shall be
returned to Company on a pro rata basis based upon the number of patients
treated with the Study Device as agreeable to both [XXXXXXX] and Company. In
addition, the amount of the research grant under Paragraph 11(e) by Company to
support the Institutional Study shall be appropriately prorated based upon the
duration of the Agreement.
14. It is understood that during the term of this Agreement, in the
interest of device integrity and patient safety, the Study Device will be used
for no purpose other than the Institutional
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Study without the written permission of the Director of Clinical Trials at
Company. After the term of this Agreement, any Equipment that remains at the
[*****] may be used for any purpose consistent with any applicable federal,
state or local laws or regulations.
15. It is anticipated that [*****] will treat a minimum of ten (10)
eligible patients with the Study Device, per year, following the Effective Date
of this Agreement. Failure to treat at least twenty (20) eligible patients with
the Study Device during the two years following the Effective Date of this
Agreement may result in termination of the Institutional Study at [*****] in
accordance with paragraph 9 and the pro rated return of Equipment as provided
for in paragraph 13.
16. The covers may not be removed from any of the Equipment listed in
paragraph 10 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.
17. (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; or (iv) arising out
of the negligence of the Study Monitor designated by Company. [*****] agrees to
notify Company promptly of any such claim, suit, action, demand or judgment and
[*****] 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 [*****] 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.
18. (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 Institutional Study, except those claims
attributable to (i) or (ii) of subparagraph 17(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 17 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 [*****] and the Risk Management Foundation of
the Harvard Medical Institutions, Inc. The minimum amounts of insurance coverage
required under this Paragraph 18 shall not be construed to create a limit of
Company's liability with respect to its indemnification under Paragraph 17 of
this Agreement.
(b) Company shall provide [*****] with written evidence of such insurance
upon request of [*****]. Company shall provide [*****] 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.
19. The terms of this Agreement can be modified only by a writing which
is signed by [*****], Principal Investigator and Company.
20. 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 [*****], such
approval shall be obtained from the Director of Public Affairs and for Company,
from its Chief Executive Officer.
21. Any notices to be delivered by either party to the others shall be
delivered as follows: if to General, to Director, Office of Technology Affairs,
[*****]; if to Principal Investigator, to [*****] [*****], [*****], and if to
Company to Xxxxxxxxx X. Xxxxx, Photoelectron Corporation, 000-0 Xxxxxx Xxxx
Xxxx, Xxxxxxx XX 00000.
22. 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 [*****]
BY: /s/Xxxxxxxxx Xxxxx BY: /s/[*****]
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Xxxxxxxxx Xxxxx, Ph.D. [*****]
TITLE: Director of Clinical TITLE: Vice President for Patents
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Trials Licensing and Industry
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Sponsored Research
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DATE: 12 October 1994 DATE: 10/24/94
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PRINCIPAL INVESTIGATOR
BY: /s/Xxxxx Xxxxxxxxx /s/[*****]
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Xxxxx Xxxxxxxxx, Ph.D. [*****], M.D.
TITLE: Chief Operating Officer
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DATE: 10/3/94
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DATE: October 12, 1994
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