EXHIBIT 10.12
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"), Rhode Island Hospital, a Lifespan partner ("Institution") and
Xxxxxxx Xxxxxx, M.D, (the "Principal Investigator") 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 the date
of the final signature.
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) Institution and Investigator agree to provide all personnel, facilities, and
resources as necessary to the performance of 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 Institution agrees 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 Xxxxxxx Xxxxxx, M.D. ceases to serve as Principal Investigator for any
reason, Principal
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RESEARCH ADMINISTRATION
Investigator and Institution shall promptly notify Cyberkinetics, and
Institution and Cyberkinetics shall use reasonable good faith efforts to
identify a mutually acceptable 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
the final date of signature of this agreement and shall terminate on December
31, 2005. Regarding the performance hereunder, time is of the essence. In case
of delayed performance, this Agreement may at Cyberkinetics' request, and
Institution's approval, be extended for subsequent periods until the Study is
completed.
2. PAYMENTS
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. In full payment and compensation for the performance under this
agreement, Cyberkinetics will provide:
- Investigational devices sufficient to conduct the study
- Payment to the Institution for IRB fees in the amount of $2,000 to
cover the initial IRB review and subsequent reviews as required by
the IRB
- Payment to the Institution per subject for actual procedures
performed and/or completed as described in the Protocol for
implantation and/or explanation of the device.
- Payment to the Institution for indirect costs at a rate of 25% of
the total costs incurred for each procedure completed.
A template study budget based on anticipated surgical procedures is attached as
Attachment II. Invoices will reflect actual services provided during each
surgical procedure.
Invoices will be generated by the Institution and sent to Cyberkinetics for
payment as patients' complete the visits required by the Study Protocol. A
detail of expenses will be sent with the invoices. Payments will be made by
Cyberkinetics within 30 days of receipt of the invoice. Cyberkinetics will make
payments to the following address:
Rhode Island Hospital
Office of Research Administration
Xxxxxxx Building 3rd floor
000 Xxxx Xxxxxx
Xxxxxxxxxx, XX 00000
Tax ID #00-0000000
Payments will reference the Protocol # DD-CP-0002.
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ADVERSE EVENTS: In the event a patient is injured or suffers an adverse reaction
as a result of participating in the Study and is in any way treated or receives
services from Institution, as a result of this adverse event, Institution will
be reimbursed for a reasonable, uncovered, actually incurred medical costs which
are directly related to the device and/or its implant following its use in
accordance with the Protocol and this Agreement at the same rate agreed upon in
this Agreement, provided that such costs are in no way attributable to the
negligence or misconduct of any agent or employee of the Institution. Adverse
Events not related to the Study and/or treatment or services not from
Institution or not related to the Study are not covered by this Agreement.
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
Institution policy and procedure 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 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.
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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;
(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 Institution 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 Institution 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
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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 device, Investigators and
Co-Investigators by site in order of highest to lowest number patients implanted
and implanting surgeon(s).
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;
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(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 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 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
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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 explanation 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.
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 Institution 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 Institution 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
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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 Institution to:
Xxxxx XxXxxx, MA, CRA
Lifespan Director, Office of Research Administration
Xxxxxxx Building 3rd floor
Providence, RI 02903
Copy to:
Xxxxxxx Xxxxxx
Rhode Island Hospital
00 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxxxx, 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.
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 state of Rhode Island, 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.
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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: 5/10/04
-----------------------
Xxxxxxx Xxxxxxxx
Chairman and CEO
RHODE ISLAND HOSPITAL
Read and acknowledged by Principal Investigator:
By: /s/ Xxxxxxx Xxxxxx Date: 04/28/04
----------------------
Xxxxxxx Xxxxxx, M.D.
By: /s/ Xxxxx XxXxxx Date: 5/3/04
----------------------
Xxxxx XxXxxx, MA, CRA
Lifespan Director, Research Admin.
