EXHIBIT 10.22
CLINICAL RESEARCH AGREEMENT
Agreement made as of 1st November 1995 between The Royal Free Hampstead (NHS)
Trust, a not-for-profit corporation having a principal place of business at Xxxx
Xxxxxx, Xxxxxxxxx, Xxxxxx, Xxxxxxx ("Trust"), Xxxxx Xxxxxxxxxx, M.D., Department
of Radiotherapy and Oncology, The Royal Free Hospital, Pond Street, London,
England ("Investigator"), and Photoelectron Corporation, a corporation having an
office at 000-0 Xxxxxx Xxxx Xxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000, Xxxxxx Xxxxxx
("Sponsor").
1. Investigator agrees to act as Principal Investigator at Trust's The Royal
Free Hospital for clinical study of the Photon Radiosurgery System (Herinafter
referred to as the "Study Device"), including study 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" (as amended
from time to time) and other studies as mutually agreed to by the parties of
this Agreement (hereinafter referred to as "Studies"). In the event of any
conflict between protocols for the Studies and the provisions of this Agreement,
the provisions of this Agreement shall govern. That portion of multi-institution
studies that are carried out by Trust are hereinafter referred to as
"Institutional Studies". Investigator agrees to comply with all appropriate
regulatory and ethical requirements for the conduct of Studies by Trust,
including those mandated by regulatory authorities of the United Kingdom and the
United States Food and Drug Administration (where applicable), to adhere to
Standard Operating Procedures for the Studies, and to maintain the Study Device
according to the instructions provided by Sponsor.
2. The Institutional Studies will be conducted by Investigator at Trust with
the prior approval and ongoing review of all appropriate and necessary review
authorities and in accordance with all English laws and regulations.
Investigator shall provide Sponsor with written evidence of review of the
Studies by Trust's Ethics Committee prior to the start of Institutional Studies
and of the Ethics Committee's continuing review and approval of the
Institutional Studies whenever it is reviewed, but at least once per year. All
study subjects will meet the legal age requirements of England, the country in
which the Institutional Studies are conducted.
3. Investigator will furnish Sponsor or its designated Study Monitor with all
data resulting from Institutional Studies in signed case report forms and in
other mutually agreed upon forms within one month after completion of a study
event. Sponsor shall have the unrestricted right to use such data including, to
the extent that subjects' consent have been obtained, subjects' names, any
identifying information, and any visual recordings, audio recordings, electronic
recordings, or other likenesses. Case report forms to be used will be those
supplied by Sponsor. Patient records shall be made available to Sponsor's
representatives upon request for comparison with case report forms. Such records
will also be made available upon request for review by representatives of
English, European Union, and United States FDA regulatory authorities. Records
of the Studies, including either the original or a copy of all Informed Consent
Forms of subjects of the Studies, shall be retained in conformance with all
applicable regulations.
4. It is understood that certain of the Studies are multi-center investigations
and publication of results from all participating sites is expected.
Investigator shall be free to publish results of Institutional Studies after
submission of multi-center results for publication, subject only to the
provisions of Paragraph 7 regarding Sponsor's confidential information, only
when notification is given by Sponsor to Trust that such a submission is no
longer planned or twelve (12) months after the termination of a multi-center
Study at all sites, whichever shall occur first. Sponsor will be furnished with
a copy of any proposed presentation of information from the Studies for review
and comment prior to submission for any form of public dissemination, in the
case of manuscripts and such for publication at least thirty (30) days prior to
submission and in the case of abstracts and such at least seven (7) days prior
to submission. At the expiration of either the thirty(30) or seven (7) day
period, whichever applies, Investigator may proceed with submission for
presentation.
5. A minimum of one journal article describing the analyzed results of each of
the Studies will be submitted for publication at the conclusion of each Study.
In addition, since any multi-center 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
each such Study. Such manuscript(s) will bear as authors, among others, all
Investigators of the Study. The order of authors will be as follows: those who
design and implement the Study will be first; the Investigator and other,
individuals from the institution contributing the largest number of patients
will be listed next; the Investigator and other individuals from the institution
contributing the second largest number of patients will be next; and so on.
6. At the conclusion of any multi-center Study and after such time as a minimum
of one multi-authored, multi-institution journal article has been published, all
Investigators from all participating institutions will be given complete access
to all of the patient data accrued in the Study.
7. In order to effectively complete an Institutional Study, it may be necessary
or desirable for the parties to disclose proprietary, trade secret and/or other
confidential information (hereinafter referred to as "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 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:
A) becomes generally available to the public through no fault of the receiving
party,
B) 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
C) 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. Trust and Sponsor agree that the Sponsor shall have the 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 Trust personnel, solely or
jointly, in the performance of the Studies (hereinafter referred to as
"Invention"). Each Invention shall be promptly reported in writing to Sponsor
and to Trust, and Sponsor shall have ninety (90) days following receipt of such
report to submit a written request to Trust to acquire rights to the reported
Invention. In the event Sponsor so elects to acquire rights to an Invention,
Trust shall promptly obtain from Trust personnel appropriate assignments of all
rights in the Invention held by such personnel and thereafter shall assign all
its rights to Sponsor.
9. This Agreement shall remain in force until the completion of Studies. Any
party hereto shall have the right to terminate the Studies 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, 7, 8, 14, 15,
16, 18, 19 and 20 shall survive the termination of this Agreement.
10. Equipment and other supplies provided by Sponsor include the following: two
Model 3 X-ray sources (each including internal radiation monitor), a Control Box
System, a 486DX Laptop Computer with applications software, color 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. All
equipment provided by Sponsor will remain assets of Sponsor. It is understood
that Sponsor will have access to the equipment at any time.
11. Sponsor agrees to support the Institutional Studies by:
A) providing a Study Device including all equipment and supplies listed in
Paragraph 10 above at no charge to Trust for the duration of the treatment
phase of the Studies;
B) providing Investigator with information and instruction pertaining to the
Study Device and its operation as needed to perform the Institutional
Studies;
C) repairing, maintaining and modifying the Study Device as needed during the
Institutional Studies;
D) monitoring the Institutional Studies; and
E) providing Trust with a research grant in the amount of (Pounds)10,500 to
be used to support the salary, fringe benefits and indirect costs of a
Data Coordinator designated by Trust for the one-year period of November
1, 1995 to October 31, 1996, and, with prior consent of Sponsor, to pay
for reasonable expenses of travel and other activity by Trust personnel to
further the legitimate purposes of this Agreement. The responsibilities of
the Data Coordinator will include overseeing the collection and assembly
of data generated by the Institutional Studies, frequent correspondence
with the Study(ies) 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 Trust of this research grant of (Pounds)l0,500 will be made by
Sponsor in quarterly payments of (Pounds)2,625 on or about October 1,
1995, January 1, 1996, April 1, 1996, and July 1, 1996.
12. All equipment and supplies listed in Paragraph 10 remain assets of Sponsor.
At the completion of the treatment phase of the Studies, all equipment and
supplies listed in Paragraph 10 above will be returned to Sponsor.
13. It is agreed that Trust will treat a minimum of twenty (20) eligible
patients with the Study Device by the end of the period of this Agreement, which
number includes those patients treated in the period of the prior Agreement
between the parties to this Agreement. Failure to treat at least twenty (20)
eligible patients with the Study Device by the end of the term of this Agreement
may result in termination of the Institutional Studies at Trust and return of
all Study Device equipment and supplies to Sponsor.
14. It is agreed, in the interest of patient safety, regulatory compliance, and
device integrity, that the Study Device will be used for no purpose other than
the Institutional Studies without the written permission of the Director of
Clinical Research and Regulatory Affairs at Sponsor.
15. It is agreed that all maintenance, repair or modification of the Study
Device equipment and supplies listed in Paragraph 10 will be carried out by
Sponsor personnel. The covers may not be removed from any of the equipment
listed in Paragraph 10 by non-Sponsor personnel. The only exceptions to this
restriction may be the removal of cover(s) for the performance of procedures
under the direct supervision of Sponsor personnel, such as testing or switching
from manual to automated control. Adherence to this policy will ensure that all
patients treated with the Study Device are treated with equipment that has met
the same standards and will protect the interests of Sponsor and Trust.
16. Terms and conditions regarding indemnification issues are found in Addendum
A and have been agreed to by all parties.
17. The terms of this Agreement can only be modified in writing in a document
signed by Trust, Investigator and Sponsor.
18. 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 Trust, such approval shall be obtained
from the Director of News and Public Affairs, and for Sponsor, from its Chief
Executive Officer.
19. Any notices to be delivered by either party to the others shall be delivered
as follows: if to Trust to ------------------------------------------------; if
to Investigator to Xxxxx Xxxxxxxxxx, MD, Department of Radiotherapy and
Oncology, The Xxxxx Xxxx Xxxxxxxx, Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxx, Xxxxxxx; and
if to Sponsor to Xxxxxx X. Xxxxxxxxxxxx, MBA, RRT, Photoelectron Corporation,
000-0 Xxxxxx Xxxx Xxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000, XXX.
20. The provisions of this Agreement shall be interpreted under the laws of the
United Kingdom.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed
as of the day, month and year first written above.
Photoelectron Corporation The Royal Free Hampstead NHS Trust
BY: /s/Xxxxxx X. Xxxxxxxxxxxx BY:
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Xxxxxx X. Xxxxxxxxxxxx, MBA, RRT (Name)
Director, Clinical Research and (Title)
Regulatory Affairs
DATE: 2 October 1995 DATE:
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BY: BY:
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Xxxxx X. Xxxxxxxxx, Ph.D. Xxxxx Xxxxxxxxxx, MD
Chief Operating Officer Investigator, The Royal
Free Hospital
DATE: DATE:
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Addendum A to Agreement between The Royal Free Hampstead NHS Trust, Xxxxx
Xxxxxxxxxx, M.D. and Photoelectron Corporation, November 1, 1995 - October 31,
1996
1. The Royal Free Hampstead NHS Trust ("Trust"), Xxxxx Xxxxxxxxxx, MD
("Investigator") and Photoelectron Corporation ("Sponsor") have entered into an
Agreement ("Agreement") that Trust and Investigator will conduct sponsored
Institutional Studies involving patients of the Trust, in the manner defined in
the Agreement between the parties and in protocols for the Studies, as amended
from time to time with the written agreement of Investigator and Sponsor.
Sponsor confirms that it is a term of its Agreement with Trust and Investigator
that Investigator shall obtain all necessary approvals of the appropriate Human
Research Ethics Committee and shall resolve with Trust any issues of a revenue
nature.
2. Trust agrees to participate by allowing the Studies to be undertaken on its
premises, utilizing such facilities, personnel and equipment as Investigator may
reasonably need for the purposes of the Studies.
3. In consideration of such participation by Trust, and subject to Paragraph 4
below, Sponsor indemnifies and holds harmless Trust and its employees and agents
against all claims and proceedings (to include any settlements or ex gratia
payments made with the consent of the parties hereto and reasonable legal and
expert costs and expenses) made or brought (whether successfully or otherwise):
A) by or on behalf of Subjects taking part in the Studies (or their
dependents) against Trust or any of its employees or agents for personal
injury (including death) to Subjects arising out of or relating to the
administration of the product(s) under investigation or any clinical
intervention or procedure provided for or required by the Study Protocol to
which the Subjects would not have been exposed except for their
participation in the Studies;
B) by Trust, its employees or agents or by or on behalf of a Subject for a
declaration concerning the treatment of a Subject who has suffered such
personal injury.
4. The above indemnity by Sponsor shall not apply to any such claim or
proceeding:
4.1 to the extent that such personal injury (including death) is caused by the
negligent or wrongful acts or omissions or breach of statutory duty of
Trust, its employees or agents;
4.2 to the extent that such personal injury (including death) is caused by the
failure of Trust, its employees or agents to conduct the Studies in
accordance with agreed upon Protocols;
4.3 unless as soon as reasonably practicable following the receipt of notice of
such claim or proceeding, Trust shall have notified Sponsor in writing of it
and shall, upon Sponsor's request, and at Sponsor's cost, have permitted
Sponsor to have full care and control of the claim or proceeding using legal
representation of its own choosing.
4.4 If Trust, its employees, or agents shall have made any admission in respect
of such claim or proceeding or taken any action relating to such claim or
proceeding prejudicial to the defence of it without the written consent of
Sponsor such consent not to be unreasonably withheld provided that this
condition shall not be treated as breached by any statement properly made by
Trust, it employees, or agents in connection with the operation of Trust's
internal complaint procedures, accident reporting procedures or disciplinary
procedures or where such statement is required by law.
Addendum A to Agreement between The Royal Free Hampsted NHS Trust, Xxxxx
Senanyake, M.D. and Photoelectron Corporation, November 1, 1995 - October 31,
1996
5. Sponsor shall keep Trust and its legal advisors fully informed of the
progress of any such claim or proceeding, will consult fully with Trust on the
nature of any defence to be advanced and will not settle any such claim or
proceeding without prior consultation with Trust.
6. Without prejudice to the provisions of Paragraph 4.3 above, Trust will use
its reasonable endeavors to inform Sponsor promptly of any circumstance
reasonably thought likely to give rise to any such claim or proceeding of which
it is directly aware and shall keep Sponsor reasonably informed of developments
in relation to any such claim or proceeding even where Trust decides not to make
a claim under this indemnity. Likewise, Sponsor shall use its reasonable
endeavors to inform Trust of any such circumstance and shall keep Trust
reasonably informed of developments in relation to any such claim or proceeding
made or brought against Sponsor alone.
7. Trust and Sponsor will each give to the other such help as may reasonably be
required for the efficient conduct and prompt handling of any claim or
proceeding by or on behalf of Subjects (or their dependents) or concerning such
a declaration as is referred to in Paragraph 3(B) above.
8. Without prejudice to the foregoing if injury is suffered by a Subject while
participating in the Studies, Sponsor agrees to operate in good faith the
Guidelines published in 1991 by The Association of the British Pharmaceutical
Industry and entitled "Clinical Trial Compensation Guidelines" (where the
Subject is a patient) and the Guidelines published in 1988 by the same
Association and entitled "Guidelines for Medical Experiments in non-patient
Human Volunteers" (where the Subject is not a patient) and shall request
Investigator to make clear to the Subjects that the Studies are being conducted
subject to the applicable Association Guidelines.
9. For the purpose of this indemnity, the expression "agents" shall be deemed
to include without limitation any nurse or other health professional providing
services to Trust under a contract for services or otherwise and any person
carrying out work for Trust under such a contract connected with such of Trust's
facilities and equipment as are made available for the Studies under Paragraph 2
above.
10. This indemnity shall be governed by and construed in accordance with English
law.
Signed on behalf of:
Photoelectron Corporation The Royal Free Hampstead NHS Trust
BY: BY:
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Xxxxx X. Xxxxxxxxx, Ph.D. (Name)
Chief Operating Officer (Title)
DATE: DATE:
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