EXHIBIT 10.9
CLINICAL STUDY AGREEMENT
CYBERKINETICS, INC.
FEASIBILITY CLINICAL STUDY OF THE CYBERKINETICS
BRAINGATE(TM) NEURAL INTERFACE SYSTEM
This document sets forth an Agreement ("Agreement") among Cyberkinetics, Inc.
("Cyberkinetics"), Xxx Xxxxxx, M.D., Ph.D. (the "Principal Investigator or PI")
and Xxxxxxx Rehabilitation Center ("Institution") regarding the performance of
certain services by the Institution for a Cyberkinetics clinical study as
described in the Protocol entitled DD-CP-0002, "Feasibility Study of the
BrainGate(TM) Neural Interface System Feasibility Study in Patients Unable to
Use Their Hands" (the "Study") a copy of which is attached as Attachment "A" and
incorporated herein by reference, in accordance with the protocol set forth
therein (the "Study Protocol"). The Effective Date of the Agreement is December
22, 2003.
WHEREAS, Cyberkinetics is desirous of conducting clinical research (hereinafter
the "Research") at the Institution.
WHEREAS, the Institution is an educational, research and/or health care
institution and is desirous of conducting the Research in order to advance its
educational and scientific clinical research missions and promote the health of
the public; the parties agree as follows:
1. PERFORMANCE
(a) The PI and Institution agrees to use their best efforts to perform the
Study in accordance with the instructions, timing and directions set forth in
the Study Protocol, and all applicable laws and regulations, as well as any
amendments to the Study Protocol that are mutually agreed to and documented by
the parties. The Principal Investigator will use his/her reasonable best efforts
to perform all the services described herein, or incidental to those described
herein, at the Institution in accordance with the highest standards of medical
and clinical research practice. The Study will be conducted in accordance with
the Study Protocol and all applicable laws and regulations, as well as any
amendments to that protocol mutually agreed to and documented by the parties
hereto. In the event of a conflict between this Agreement and the Study Protocol
the terms of this Agreement will govern. The parties acknowledge that this is a
multi-center study with overall enrollment and implant limits, so Principal
Investigator agrees to coordinate patient enrollments with Cyberkinetics such
that these limits are not exceeded. The PI and Institution agree to ensure that
an Institutional Review Board ("IRB") that complies with the requirements of 21
C.F.R. Part 56 will be responsible for the initial and continuing review and
approval of the Study. The parties also agree to promptly report to the IRB and
each other all changes in the research activity and all unanticipated problems
involving risk to human subjects or others. Additionally the parties agree to
not make any changes in the study without IRB approval except where necessary to
eliminate apparent immediate hazards to human subject.
(b) If Xxx Xxxxxx, M.D., Ph.D. ceases to serve as Principal Investigator for any
reason, Principal Investigator and Institution shall promptly notify
Cyberkinetics, and Institution and Cyberkinetics shall use reasonable good faith
efforts to identify a mutually acceptable
Confidential 1/7/2004
Page 1
replacement within thirty (30) days. If a suitable replacement Principal
Investigator cannot be identified within the thirty day period, Cyberkinetics
shall have the right to terminate this Agreement as provided in Section 12.
Institution will make reasonable efforts to complete the study for patients
that are already enrolled or work with Cyberkinetics to transfer these patients
to another Study site.
(c) Performance of the Study under this Agreement shall commence not later than
March, 2004, unless appropriate IRB approval(s) are not obtained by March, 2004,
in which case performance shall commence immediately after obtaining such
approvals. Regarding the performance hereunder, time is of the essence. In case
of delayed performance, this Agreement may at Cyberkinetics' request, be
extended for subsequent periods until the Study is completed.
(d) In full payment and compensation for the performance under this Agreement,
Cyberkinetics will cover all direct and indirect costs of the Study as agreed to
on the separate budget in Attachment B. Invoices will be generated by the PI and
sent to Cyberkinetics for payment. An initial payment of will be made to cover
IRB and start-up costs. Subsequently, the PI will invoice Cyberkinetics as
patients complete the visits required by the Study Protocol. Payments will be
made by Cyberkinetics within 30 days of receipt of invoice.
2. TIME FRAME
The parties anticipate that enrollment and implantation of up to five subjects
will be completed within four (4) months of the Effective Date of this
Agreement or final Institution Review Board ("IRB") and Food and Drug
Administration ("FDA") Investigational Device Exemption ("IDE") approval,
whichever occurs later.
3. INVENTIONS; WARRANTIES
(a) All rights, title and interest in and to Cyberkinetics' BrainGate(TM) and
related accessories (the "Device") shall remain the exclusive property of
Cyberkinetics; the Institution and the Principal Investigator shall acquire no
rights of any kind whatsoever with respect to the Device, the know-how incident
thereto and any patent applications and patents related thereto as a result of
performance under this Agreement or otherwise. Institution and the Principal
Investigator agree that all inventions, discoveries and technology relating to
the Device, whether patentable or not, conceived or reduced to practice by the
Principal Investigator, solely or jointly with others as a result of work done
under this Agreement ("Inventions") shall be and remain, at all times, the sole
and exclusive property of Cyberkinetics. Institution shall promptly report in
writing any Invention to Cyberkinetics, and shall ensure that at all times the
Principal Investigator and any investigator participating in the Study that
could be deemed to be an "inventor" of any such Inventions shall be subject to a
valid and binding agreement assigning all of his or her rights to any such
Inventions (without cost to Cyberkinetics) to the Institution (which rights are
hereby assigned to Cyberkinetics pursuant to this Section 3). Any and all acts
reasonably necessary to assist Cyberkinetics in perfecting its right to any and
all Inventions and any patent applications or patents related thereto shall be
performed by the Institution, and/or
Confidential 1/7/2004
Page 2
Principal Investigator at Cyberkinetics' expense. Without limiting the
foregoing, the Institution shall be entitled to a royalty-free license to use,
for research purposes only, inventions that are developed, discovered or reduced
to practice in the performance of the Study which are owned by Cyberkinetics.
The Institution and the Principal Investigator certify by the execution of this
Agreement, that to their knowledge they have not entered, and will not enter,
into any contractual agreement or relationship which would in any way conflict
with or compromise Cyberkinetics' proprietary interest in, or rights to, any
inventions, discoveries or technology existing at the time of the execution of
this Agreement or directly arising out of or materially related to the
performance hereunder.
(b) The Institution warrants that it or the Principal Investigator will obtain
from all individuals subject to the Study an adequate and properly executed
informed consent. The Institution also warrants that the informed consent form
complies with all applicable federal and state laws and regulations. The
Institute further warrants that it and the Principal Investigator will comply
with all federal and state laws and regulations concerning record keeping,
project conduct, receipt and disposition of product, and obtaining of adequate
informed consent from individuals subject to treatment in the Study, and that
it, the Principal Investigator, and any subinvestigators will comply with the
confidentiality requirements established in Section 9 of this Agreement.
4. DATA
Except as provided in Section 8 of this Agreement, all data and results
generated or produced in the Study except patient and hospital records,
including all information required on case report forms in the Protocol ("Data")
shall be the sole exclusive property of Cyberkinetics. The investigator shall
prepare and submit to Cyberkinetics all original case report forms as provided
in the Protocol. Investigator shall have the right to retain copies of all data
and results arising from its participation in the Study solely for the purposes
permitted by this Agreement. The Investigator may use such Data for research and
education purposes in accordance with this Agreement, but, except as set forth
in Section 8, will not transfer any such Data collected under the Protocol to
any third party without the prior written permission of Cyberkinetics. All Data
collected under the Protocol shall be delivered to Cyberkinetics in a timely
manner throughout the performance of this Study, as provided in the Protocol,
and no later than ten (10) working days after the termination of this Agreement
or on such date as Cyberkinetics otherwise requests delivery of the Data.
5. RECORD KEEPING/RETENTION
Investigator agrees to maintain complete and up-to-date Study records during the
Study including Case Report Forms and the Study Site file, which includes all
Study-related correspondence. Investigator agrees to sign a statement in each
patient's Case Report Form attesting that the data contained therein are an
accurate accounting of the treatment, care, and events surrounding the patient's
involvement in the Study.
Investigator will retain all records for this Study for the last to expire of:
(a) Two (2) years after the FDA or other national regulatory body approves the
regulatory application for product clearance;
Confidential 1/7/2004
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(b) Two (2) years following the termination or withdrawal of the regulatory
agency exemption (e.g., Investigational Device Exemption (IDE) application)
under which the Study was conducted;
(c) As defined by local, state and federal law and regulations; or
(d) In any event no later than ten (10) years after the conclusion of the Study.
To avoid any possible errors, Investigator will contact Cyberkinetics prior to
the destruction of records or in the event of accidental loss or destruction of
any Study records.
The PI shall make periodic reports to Cyberkinetics, including a final written
report on the performance of the Study, upon its completion and shall promptly
respond to Cyberkinetics' reasonable inquiries regarding the status of the
Study. The PI agrees to promptly report to Cyberkinetics adverse experiences
that occur in the course of the Study.
6. CYBERKINETICS RIGHT OF REASONABLE INSPECTION
Personnel from Cyberkinetics (or its representatives) may call on Investigator
periodically at mutually convenient times to monitor and/or audit the Study and
answer procedural questions. Investigator agrees, as defined in the Protocol, to
make all Study records and Study participants' medical records available for
comparison and/or copying if requested by Cyberkinetics (or its representatives
subject to compliance with patient privacy and confidentiality rights).
Investigator also agrees to cooperate with representatives of the U.S. FDA or
any other regulatory agency in the event of an inspection of this Study, and
will provide the regulatory agency representative access to the above-described
records. Institution agrees to notify Cyberkinetics immediately upon the
commencement of an inspection by FDA or any other government authority
concerning the Study and to provide continual communication regarding the
progress of any inspection.
7. USE OF NAME/PUBLICITY
No party shall, without the prior written consent of the affected party, use in
advertising, publicity, press release, or otherwise, the name, trademark, logo,
symbol, or other image of the affected party. Except as permitted in Section 8,
the Investigator and Institution (which shall include its employees, agents and
representatives) shall not issue or disseminate any press release or statement,
nor initiate any communication of information regarding this Study, written or
oral, to the communications media or any third party without the prior written
consent of Cyberkinetics.
8. SCIENTIFIC PRESENTATIONS AND PUBLICATIONS
The Investigator and/or Institution may present or publish the Data in
appropriate scientific journals or other professional publications/forums. It is
the intent of this study to be a multi-center study and presentation and
publication of the pooled, multi-center results will occur before any individual
site results or additional analyses are presented or published. Authorship will
be determined by the Investigators at each study site together with
Cyberkinetics using appropriate standards for research authorship. It is
anticipated that authorship for multi-center presentations and publications will
include the scientific inventor(s) of the BrainGate devices, Investigators and
Co-Investigators by site in order of highest to lowest number patients implanted
and implanting surgeon(s).
Confidential 1/7/2004
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Investigator shall submit to Cyberkinetics for its review, a copy of any
proposed abstract for presentation or manuscript resulting from the Study at
least sixty (60) days prior to the estimated date of submission for presentation
or publication, and if no response is received within, sixty (60) days of the
date submitted to Cyberkinetics, it will be conclusively presumed that the
presentation or publication may proceed without delay. If Cyberkinetics
determines that the proposed presentation or publication contains patentable
subject matter which requires protection, Cyberkinetics may require the delay of
presentation or publication for a period of time not to exceed sixty (60) days
for the purpose of filing patent applications. At the end of the sixty (60) day
period the authors shall be free in their sole discretion to publish the results
of the Study.
In all presentations and publications, credit shall be given to Cyberkinetics
for its sponsorship of the Study and the supply of the Device under the Study.
9. CONFIDENTIALITY
For the purposes of this Agreement, "Confidential Information" means all
information provided by or on behalf of Cyberkinetics to the Investigator in
connection with the Study by the Investigator in connection with the Study,
whether written, graphic or oral, except the following: (i) Information that is
now or subsequently becomes public without breach of this Agreement; (ii)
Information known by the Investigator, as evidenced by written records, prior to
the date of this Agreement; (iii) Information that the Investigator received
from a third party not under any obligation to keep such information
confidential; and (iv) was developed independently by the Institution.
Except for publication of the Data pursuant to Section 8 hereof, the
Investigator agrees to maintain all Confidential Information in confidence and
not to use or disclose for a period not to exceed three (3) years any
Confidential Information to any third party without the express written consent
of Cyberkinetics. The Investigator shall disclose Confidential Information only
to those employees who require such information for the purposes of this
Agreement and who are bound by a like obligation of confidentiality.
Upon the completion of the Study, the Institution and the Principal Investigator
agree to return all copies or embodiments of Confidential Information upon the
written request of Cyberkinetics.
10. LIABILITY/INSURANCE/WARRANTY DISCLAIMER
Cyberkinetics will indemnify, hold harmless and defend the Principal
Investigator and Institution (including the Principal Investigator, any
employees of the Institution and the Institution's, agents and representatives,
the "Indemnified Parties") from and against any claims, liabilities, costs,
damages, expenses and reasonable attorneys' fees (collectively, "Losses")
relating to or resulting from the use of the Device in the Study (and not
resulting from the performance of, or complications arising from, standard
clinical care procedures); provided that Cyberkinetics shall have no obligation
to indemnify, hold harmless and defend the Indemnified Parties under this
Section 10 for any claim unless (1) the Principal Investigator and the
Institution, its agents, servants and employees are shown to have adhered to and
complied with all specifications and directions of the Protocol for the Study,
all applicable FDA and other regulatory requirements
Confidential 1/7/2004
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and all Cyberkinetics written instructions concerning the administration and use
of the Device in the Study Protocol; (2) Cyberkinetics is promptly notified in
writing of such claim or suit; and (3) Cyberkinetics has full control of the
defense, including settlement of the claim or suit and receives the full
cooperation of the Institution and Principal Investigator, its agents and
employees. Notwithstanding the foregoing, Cyberkinetics shall have no liability
to Indemnified Parties, or any obligation to indemnify hereunder, if the Losses
have resulted from negligence, recklessness or willful malfeasance of any of the
Indemnified Parties.
Institution shall, to the extent permitted by law, be responsible for its own
acts in conducting the Study, limited solely and exclusively to the extent such
acts are judicially determined by a court of last resort to have arisen out of,
or result from: (i) the negligence recklessness or willful malfeasance on the
part of the Institution; or (ii) the failure of the Institution to (1) comply
with any applicable FDA or other regulatory requirements, or (2) adhere to the
terms of the Protocol or Cyberkinetics written instructions concerning the
administration and use of the Device involved in the Study. The parties agree
that this is only a statement setting forth the limited responsibility of the
Institution solely for its own acts of judicially determined negligence,
recklessness, or willful malfeasance, and is not and shall not be construed as
any contractual or other obligation to indemnify Cyberkinetics or any third
party.
Cyberkinetics will maintain, during the term of this Agreement, Comprehensive
General Liability Insurance (including products liability, contractual
liability, clinical testing liability and broad form property damage coverage)
with reputable and financially secure insurance carriers to cover the activities
of the clinical study arising out of this Agreement, with minimum limits of
$5,000,000 per occurrence. Coverage will be written to cover claims incurred,
discovered, manifested, or made during or after the expiration of this
Agreement.
The Principal Investigator and Institution each understand and agree that the
Device and the associated implantation and explantation procedures are
experimental in nature. CYBERKINETICS MAKES NO REPRESENTATIONS AND EXTENDS NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE DEVICE
EXCEPT THAT CYBERKINETICS WARRANTS THAT THE DEVICE HAS BEEN MANUFACTURED IN
ACCORDANCE WITH ANY AND ALL FDA FILINGS WITH RESPECT TO THE DEVICE. THERE ARE NO
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, PUNITIVE OR
CONSEQUENTIAL DAMAGES, HOWEVER CHARACTERIZED, ARISING OUT OF OR IN CONNECTION
WITH THIS AGREEMENT.
11. RELATIONSHIP
The Principal Investigator, including its agents and employees, shall be an
independent contractor at all times, and shall not be an agent of Cyberkinetics
and shall have no actual apparent or implied authority to bind Cyberkinetics in
any manner or any obligation what so ever.
Confidential 1/7/2004
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12. TERMINATION OF AGREEMENT OR TERMINATION OF A PARTY'S PARTICIPATION IN
AGREEMENT
Any party has the right at any time, within sixty (60) days prior written notice
to each of the other parties, to terminate this Agreement for any cause or no
cause. In the event of premature termination of this Study, the PI will be
reimbursed appropriately for patients enrolled up to the date of termination for
whom Cyberkinetics receives a properly completed Case Report Form and
Cyberkinetics will pay for any uncancelable obligations prior to termination
date; provided, however that no payment will be made to PI if the Study is
terminated at Institution because the Principal Investigator/ Institution did
not adhere to the Study Protocol. Upon the termination or expiration of this
Agreement, the Institution shall return to Cyberkinetics, at Cyberkinetics'
expense, any remaining Devices.
The obligations of the parties under Sections 3, 4, 5, 6, 7, 8, 9, 10, 12 and
14 shall survive the termination or expiration of this Agreement.
13. NOTICES
Any notice required or permitted to be given hereunder shall be in writing and
shall be considered given when mailed by pre-paid registered or certified mail,
return receipt requested, or delivered by hand, to the parties at the following
addresses (or such other address as a party may specify by notice hereunder):
If to the PI:
Xxx Xxxxxx, M.D., Ph.D.
00 Xxxxxxxxx Xxxx
Xxxxxxxxxx, XX 00000
If to the Institution to:
Xxxxxxx Xxxxx
President
Xxxxxxx Rehabilitation Center
000 Xxxxxx Xxxx
Xxxxxxx, XX 00000
If to Cyberkinetics to:
Xxxxxxx Xxxxxxxx
Cyberkinetics, Inc.
000 Xxxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
With a copy to:
Xxxxxxxxxxx & Xxxxxxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Esq.
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14. MISCELLANEOUS
(a) This Agreement represents the entire understanding as of the Effective Date
hereof between the parties with respect to the patient matter hereof, and
supersedes all prior agreements, negotiations, understanding, representations,
statements and writings between the parties relating thereto. No modification,
alteration, waiver or change in any of the terms of this Agreement shall be
valid or binding upon the parties hereto unless made in writing and duly
executed by each of the parties hereto.
(b) This Agreement shall be governed by and construed in accordance with the
laws of the Commonwealth of Massachusetts, irrespective of any conflicts of law
principles. Each of the parties agrees to the jurisdiction of the federal and
state courts sitting in Boston, Massachusetts, with respect to any dispute
arising between the parties.
(c) This Agreement may not be assigned by any party without the prior written
consent of the other parties.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.
CYBERKINETICS, INC.
By: /s/ Xxxxxxx Xxxxxxxx Date: 3/26/04
-------------------------
Xxxxxxx Xxxxxxxx
Chairman and CEO
PRINCIPLE INVESTIGATOR
By: /s/ Xxx Xxxxxx Date: 2/23/04
-------------------------
Xxx Xxxxxx, M.D., Ph.D.
INSTITUTION
By: /s/ Xxxxxxx Xxxxx Date: February 23, 2004
------------------------
Xxxxxxx Xxxxx
President, Xxxxxxx Rehabilitation Center
000 Xxxxxx Xxxx, Xxxxxxx, XX 00000
Confidential 1/7/2004
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