CLINICAL TRIAL SERVICES AGREEMENT
This Agreement is made and entered into this 16th day
of March 2007 by and between:
HARVARD CLINICAL RESEARCH INSTITUTE, INC. ("HCRI")
930 Commonwealth Avenue
Boston, Massachusetts 02215
and
VICOR TECHNOLOGIES, INC. ("VICOR")
2300 NW Corporate Boulevard, Suite 123
Boca Raton, FL 33432
"Prospective, Multi-Center Study Of The Ability Of The PD2i
Cardiac Analyzer To
Predict Risk Of Ventricular TachyArrhythrnic Events Such As, Sudden
Cardiac
Death( SCD), VentricuLar Fibrillation (VF) or Ventricular
Tachycardia in High
Risk Patients"
Protocol # VTI-2003-03
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
2
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
WHEREAS, VICOR desires to engage HCRI for the purpose of providing
Clinical
Trial Services, as defined in Exhibit A to this Agreement, which
will serve as
the Scope of Work and budget for the Agreement, for Protocol
#VTI-2003-03,
entitled, Prospective, "Multi-Center Study Of The Ability Of The
PD2i Cardiac
Analyzer To Predict Risk Of Ventricular TachyArrhythmic Events Such
As, Sudden
Cardiac Death (SCD), Ventricular Fibrillation (VF) or Ventricular
Tachycardia
(VT) in High Risk Patients," dated May 5, 2005 (incorporated herein
by
reference);
WHEREAS, HCRI and its professionals have experience in the
development and
administration of clinical trials of various Investigational
Products; and
WHEREAS, the parties hereto deem it to be in their individual and
mutual
best interest to set forth the terms and conditions of their
relationship
herein; and
NOW, THEREFORE, in consideration of the mutual covenants and
premises
herein contained, HCRI and VICOR agree as follows:
1.
DEFINITIONS.
"Clinical Sites" shall mean the hospitals and other medical
institutions
that are participating as clinical study sites and seeing patients
in
accordance with the protocol.
"Clinical Trial Data" shall mean data provided in reference to this
Study
by the Clinical Sites during the Trial and may include, but is not
limited
to, information contained in case report forms, core laboratory
data, if
any, and clinical laboratory data, if any.
"Clinical Trial Services" shall mean the Services described in
Exhibit A to
this Agreement, which shall serve as the Scope of Work and budget
for this
Agreement.
"Investigational Product" shall mean the device, pharmaceutical, or
biopharmaceutical product under investigation for this Trial.
"Pre-Existing Intellectual Property" means all proprietary rights,
including patents, copyrights, trade secrets and other proprietary
information relating to the Investigational Product and owned or
licensed
by VICOR.
"Principal Investigators" shall mean collectively the investigator
who
functions as overall principal investigator for the Trial and the
investigators who function as principal investigators at the
Clinical
Sites.
"Protocol" shall mean the investigational plan developed pursuant
to this
Agreement for performing the Trial.
"Trial" shall mean the clinical trial described in the Protocol.
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
1
2.
VICOR LIAISON.
VICOR shall designate a person who shall be VICOR's primary liaison
(the
"Liaison") with HCRI for all purposes pursuant to this Agreement.
The Liaison's
duties shall include responding promptly and fully to all
reasonable requests
from HCRI. The Liaison may consult informally with HCRI's
representatives, both
in person and by telephone, regarding the Trial. All notices and
approvals to be
made by VICOR pursuant to this Agreement shall be made by or
through the
Liaison, and HCRI shall be entitled to look solely to the Liaison
for such
notices and approvals. The Liaison shall be Mr. David Fater,
President, Chief
Executive and Financial Officer.
3.
PRIMACY OF HEALTH CARE MISSION.
VICOR acknowledges that the primary mission of HCRI is health care,
education and the advancement of knowledge and, consequently, all
Clinical Trial
Services, (described in Exhibit A), provided by HCRI under this
Agreement shall
be performed in a manner best suited to carry out that mission.
Furthermore,
HCRI does not guarantee specific results of the Trial.
4.
DATA OWNERSHIP.
VICOR shall have ownership rights to the Clinical Trial Data, as
well as to
the content of. analyses and reports relating to the Trial which
are delivered
to VICOR by HCRI. VICOR shall be free to use the Clinical Trial
Data and the
content of such analyses and reports for its own business purposes,
provided
however that VICOR agrees that it shall be solely liable for the
content of the
analyses or reports if it changes or otherwise modifies such
analyses or reports
in any way at any time from the form in which they were delivered
to VICOR. HCRI
shall own all rights to the procedures, methodologies, computer
programs,
analytic tools, know how and work papers used and/or generated by
HCRI in
conducting such analyses relating to the Trial (collectively, "HCRI
Know-How").
VICOR agrees not to reproduce and/or disseminate such Know-How for
its benefit
or the benefit of any third party.
5.
VICOR'S OBLIGATIONS.
a. Compensation and Payment. In consideration for its services,
HCRI will
receive remuneration equal to an estimated fee of $1,270,460 as
detailed in
attached Exhibit A. VICOR and HCRI expressly agree that such fee
represents an
estimate arrived upon in good faith and based on the parties'
mutual
understanding of the Scope of Work at the outset of this Agreement.
This
estimated fee will be invoiced according to the payment schedule
provided in
attached Exhibit 13. VICOR agrees to pay each invoice upon receipt
of the
invoice. To the extent there is no good faith dispute as to the
validity of the
invoice; accounts not paid within thirty (30) days of receipt of an
invoice will
be considered overdue. Overdue accounts will be charged 1.5% of the
invoice
total for each month that the invoice remains unpaid.
b. Changes in Scope. Amounts paid by VICOR under this section may
be
increased if the Scope of Work detailed in Exhibit A changes. If
changes in
scope are required by VICOR, a Contract Change Order describing the
modification
to the Scope of Work and detailing the associated adjustment to the
project
costs will be issued by HCRI and agreed to in writing between HCRI
and VICOR.
Additionally, VICOR acknowledges that certain adjustments to the
estimated fee
may be necessary during the term of this Agreement along with a
detailed
explanation of same. HCRI shall provide VICOR with prompt notice of
any
adjustment deemed
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
2
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
necessary. Further, the parties shall review and address any
dispute relating to
all such adjustments.
c. Use of Funds. HCRI shall monitor expenditures, in accordance
with its
policies, to ensure that the funds provided by VICOR are spent in
accordance
with this Agreement and approved budgets. However, HCRI shall have
the right to
rebudget funds between cost categories as deemed necessary by HCRI.
d. Representations Concerning the Investigational Product. VICOR
represents
warrants and agrees that the Investigational Product is produced in
accordance
with all applicable laws and regulations. VICOR further represents,
warrants and
agrees that appropriate federal and state government authorization
has been or
will be obtained for the use of the Investigational Product for the
Trial.
e. Adverse Reactions. VICOR agrees that HCRI is not responsible for
the
costs of diagnosis, care and treatment of any undesirable side
effects, adverse
reactions, illness or injury to a participant in the Trial which
result from
participation in the Trial, except to the extent such costs arise
directly from
HCRI's gross negligence or reckless or intentional misconduct. This
section is
not intended to create any third-party contractual benefit for any
participants
in the Trial.
f. Immediate Notification of Adverse Reactions. VICOR shall
immediately
transmit to HCRI any information regarding any Serious Adverse
Events associated
with the use of the Investigational Product. HCRI shall immediately
transmit to
VICOR and the sites, or their designees, any information regarding
previously
unreported Serious Adverse Events experienced by participants in
the Trial.
6.
CONFIDENTIALITY; PUBLICATION.
a. VICOR Confidential Information Defined. "VICOR Confidential
Information"
shall mean information provided to HCRI by VICOR pursuant to this
Agreement
which is marked "Confidential" when disclosed or otherwise treated
as
confidential by VICOR. If not in tangible form, VICOR agrees to
identify such
information as confidential when disclosed and make reasonable
efforts to
confirm in writing the confidential nature of the information
within thirty (30)
days of such disclosure. Notwithstanding the foregoing, "VICOR
Confidential
Information" shall not include information or materials that: (i)
were in the
possession of HCRI before receipt from VICOR; (ii) were or become
available to
the public through no fault of HCRI; (iii) have been received in
good faith by
HCRI from a third party who does not owe a duty of confidentiality
to VICOR;
(iv) have been independently developed by HCRI without any use of
VICOR
Confidential Information; or (v) are required to be disclosed by
law.
b. Limited Delivery of VICOR Confidential Information. The free
dissemination of information is an important policy of HCRI. To
minimize
questions concerning the confidentiality of disclosures, trade
secrets, or
proprietary data or information, VICOR agrees to limit to the
extent possible
the delivery of VICOR Confidential Information to HCRI.
c. Publication. In accordance with this subparagraph (c), HCRI
shall have
the right to publish or otherwise publicly disclose the results of
the Trial and
other information gained in
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
3
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
the course of this Agreement. During the term of this Agreement and
for a period
of one (I) year following the termination or expiration of this
Agreement, to
protect patent rights and VICOR Confidential Information, HCRI
shall submit
manuscripts, abstracts and similar material generated by HCRI as a
result of
this Agreement ("Publications") to VICOR via the VICOR Liaison for
review and
comment thirty (30) days prior to the planned publication or
disclosure date.
VICOR will advise HCRI within thirty (30) days of receiving any
such
Publication of: (i) any disclosure of information that will result
in a loss of
patent rights ("Patentable Material"), and (ii) any disclosure of
VICOR
Confidential Information. If VICOR informs HCRI that it is
desirable to file one
or more patent applications on Patentable Material disclosed in the
Publication,
HCRI may, at its option: (i) delete the Patentable Material and
publish or
disclose the Publication; or (ii) postpone Publication for not more
than sixty
(60) days beyond the date on which the Publication was provided to
VICOR to
provide time to file such patent applications. Upon mutual
agreement that the
Publication contains VICOR Confidential Information, HCRI will
delete such
information. Any dispute relating to the Publication shall be
addressed and
resolved by the parties.
7.
PUBLICITY.
No press release, advertising, promotional sales literature or
other
promotional written statements or promotional oral statements to
the public in
connection with or alluding to work performed under this Agreement
or the
relationship between the parties created by it, having or
containing any
reference to HCRI or any of its affiliates or VICOR, shall be made
by either
party without the prior written approval of the other party. HCRI
shall,
however, have the right to acknowledge VICOR's support of the
investigations
under this Agreement in HCRI's brochure, web site, scientific
publications and
other scientific communications.
8.
INVENTIONS.
HCRI acknowledges VICOR's ownership interest in all Pre-Existing
Intellectual Property in the Investigational Product. HCRI agrees
to take no
action inconsistent with VICOR's ownership of such Pre-Existing
Intellectual
Property.
During the course of the Trial, should any new inventions,
developments or
improvements (whether patentable or not) be conceived and reduced
to practice by
HCRI or VICOR, the parties agree that ownership shall be determined
by
inventorship in accordance with U.S. Patent Laws. The parties
further agree to
provide each other with prompt notice of any such new invention,
development or
improvement in order for the parties to address related issues,
including but
not limited to, the preparation and filing of one or more patent
applications
and negotiation of cross-licensing opportunities which may be
mutually
desirable.
Notwithstanding the foregoing, the parties agree that nothing in
this
Agreement by implication or otherwise shall constitute a grant of
rights to any
Pre-Existing Intellectual Property or to any new invention,
development or
improvement owned or developed by either party during or after the
Trial.
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
4
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
9.
INDEMNIFICATION.
a. Vicor shall indemnify, defend and hold harmless HCRI and its
trustees,
officers, medical and professional staff, employees, agents,
subcontractors, and
their respective successors, heirs and assigns ("HCRI
Indemnities"), against any
liability, damage, loss, or expense (including reasonable
attorneys' fees and
expenses of litigation) incurred by or imposed upon the HCRI
Indemnities 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)
resulting from
the Protocol; (ii) arising out of any side effect or adverse
reaction, illness
or injury resulting from the Protocol or the Indemnities'
performance under this
Agreement and occurring to any person involved in the Trial; or
(iii) arising
out of damage to any property resulting from and occurring during
the
Indemnities' performance of this Agreement.
b. HCRI shall indemnify, defend and hold harmless Vicor and its
trustees,
officers, medical and professional staff, employees, agents,
subcontractors and
their respective successors, heirs and assigns ("Vicor
Indemnities"), against
any liability, damage, loss, or expense (including reasonable
attorneys' fees
and expenses of litigation) incurred by or imposed upon the Vicor
Indemnities or
any one of them in connection with any claims, suits, actions,
demands or
judgments arising out of or caused by: (i) the falsity of any
representation or
the breach of any warranty made by HCRI in this Agreement; (ii)
HCRI's default
under any term or provision hereof on its part to be observed and
performed; or
(iii) the negligent activities, or reckless or intentional
misconduct of HCRI,
its trustees, officers, medical and professional staff, employees,
agents or
subcontractors. Notwithstanding the foregoing, HCRI's total
liability for
indemnification hereunder shall not exceed one (I) times the
compensation
received by HCRI under this Agreement.
c. Either party's indemnification under 9(a) (b) shall not apply to
the
extent that any liability, damage, loss or expense is directly
attributable to
the grossly negligent activities, or reckless or intentional
misconduct of the
Indemnities.
d. Both parties agree, at its own expense, to provide attorneys
reasonably
acceptable to the Indemnitee 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.
e. Both parties agree to provide each other with prompt written
notice of
any claim, suit, action, demand or judgment as described in Section
9(a) of
which it has actual knowledge or a reasonable belief thereof.
f. This Section 9 shall survive expiration or termination of this
Agreement.
10.
INSURANCE.
a. VICOR 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
Index-al-lams as
additional insured. Such comprehensive general liability insurance
shall provide
(i) product liability coverage and (ii) broad form contractual
liability
coverage for VICOR's indemnification under the preceding section.
If
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
5
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
VICOR 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 HCRI and HCRI's
insurance carrier.
The minimum amounts of insurance coverage required under this
section shall not
be construed to create a limit of VICOR's liability with respect to
its
indemnification under the preceding section of this Agreement.
b. VICOR shall provide HCRI with written evidence of such insurance
upon
request of HCRI. VICOR shall provide HCRI with written notice at
least fifteen
(15) days prior to the cancellation, non-renewal or material change
in such
insurance.
c. VICOR shall maintain such comprehensive general liability
insurance (i)
during the continuance of the Trial or the term of this Agreement,
whichever is
longer, and (ii) for a reasonable period after the period referred
to in (c)(i)
above which in no event shall be less than six (6) years.
d. This Section 10 shall survive expiration or termination of this
Agreement.
11.
LIMITATION OF LIABILITY AND REMEDIES.
a. IN THE EVENT OF ANY MA'T'ERIAL BREACH, OMISSION, OR NEGLIGENCE
BY HCRI
IN THE PERFORMANCE OF ITS OBLIGATIONS UNDER THIS AGREEMENT, VICOR
AGREES THAT
ITS FIRST RECOURSE SHALL BE TO SEEK REPERFORMANCE, BY HCRI, OF THE
SERVICES
DETRIMENTALLY IMPACTED BY SUCH ERROR OR OMISSION AT THE SOLE COST
AND EXPENSE OF
HCRI. IN NO EVENT SHALL HCRI'S LIABILITY FOR SUCH MATERIAL BREACH
OR OMISSION
EXCEED THE FEES PAID TO HCRI FOR THE AFFECTED SERVICE. VICOR
FURTHER AGREES THAT
HCRI SHALL NOT BE LIABLE TO VICOR FOR ANY SPECIAL, INDIRECT,
EXEMPLARY,
INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO
ANY DAMAGES
RESULTING FROM LOSS OF DATA, DELAY IN- THE STUDY, LOSS OF PROFITS
OR LOSS OF
BUSINESS ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY
PRODUCTS,
SERVICES OR MATERIALS FURNISHED HEREUNDER, EVEN IF HCRI HAS BEEN
ADVISED OR
SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES.
b. EXCEPT AS EXPRESSLY STATED TO THE CONTRARY, THE LIMITATIONS
STATED IN
SECTION 11 (a) SHALL APPLY WHETHER THE ASSEKLED CLAIM, LIABILITY OR
DAMAGES ARE
BASED ON CONTRACT (INCLUDING BUT NOT LIMITED TO BREACH OF
WARRANTY), TORT
(INCLUDING BUT NOT LIMITED TO NEGLIGENCE AND STRICT LIABILITY) OR
ANY OTHER
LEGAL OR EQUITABLE GROUNDS, AND REGARDLESS OF WHETHER THE ASSERTED
CLAIM,
LIABILITY OR DAMAGES ARISE FROM PERSONAL INJURY, PROPERTY DAMAGE,
ECONOMIC LOSS
OR ANY OTHER KIND OF INJURY, LOSS OR DAMAGE. EACH OF SUCH
LIMITATIONS IS
INTENDED TO BE ENFORCEABLE REGARDLESS OF WHETHER ANY OTHER
EXCLUSIVE OR
NONEXCLUSIVE REMEDY UNDER THIS AGREEMENT FAILS OF ITS ESSENTIAL
PURPOSE.
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
6
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
c. VICOR acknowledges that the fees described in Exhibit A and the
other
economic terms of this Agreement and its Exhibits reflect the
allocation of
risks and the limitations of HCRI' s liability hereunder.
12.
TERM; TERMINATION.
a. Term. This Agreement shall continue in full force and effect
until VICOR
has provided final payment to HCRI. Termination of this Agreement,
however,
shall not relieve the obligations undertaken by the parties in
Sections 6, 7, 8,
9, 10, and 11.
b. Termination without Cause. Either party may terminate this
Agreement
without cause by providing sixty (60) days written notice to the
other party.
c. Termination for Bankruptcy/Insolvency. Either party may
immediately
terminate this Agreement if the other party files a petition in
bankruptcy or is
adjudicated as bankrupt or insolvent, or makes an assignment for
the benefit of
creditors, or an arrangement pursuant to any bankruptcy law, or if
the other
party discontinues its business or if a receiver is appointed for
the other
party or the other party's business who is not discharged within
thirty (30)
days.
d. Termination for Cause. Either party may terminate this Agreement
for
cause after providing the breaching party with thirty (30) days
written notice
of the breach and the opportunity to cure the breach during such
period.
e. Effect of Termination. Upon termination of this Agreement for
any
reason, VICOR shall promptly pay HCRI on a time and materials basis
for all work
performed and expenses incurred through the effective date of
termination
including, without limitation, amounts due for closeout costs and
non-cancelable
commitments incurred through that date, if such costs exceed the
amounts
previously paid under this Agreement. Upon termination or
expiration of this
Agreement, HCRI shall retain title to all equipment purchased or
fabricated by
it with funds provided by VICOR under this Agreement.
13.
COMPLIANCE WITH LAWS AND POLICIES.
a. Compliance with Law. VICOR and HCRI shall comply with all
applicable
federal, state and local laws, regulations and guidelines,
including but not
limited to any such laws, regulations or guidelines concerning
human subject
research.
b. Adherence to Policies. VICOR recognizes that in performing
services
under this Agreement, HCRI is bound by and all rights of VICOR will
be subject
to the Faculty of Medicine of Harvard University's Faculty Policies
on Integrity
in Science.
c. Financial Disclosure. Pursuant to any applicable federal, state
and
local laws, regulations or guidelines, VICOR, Clinical Sites,
Principal
Investigators and any employees under the supervision of Principal
Investigator
who are directly involved in this Study ("Parties of Interest") may
be required
to complete and sign a financial conflicts of interests disclosure
form(s). Such
forms must disclose any financial interests and/or investments in
VICOR held by
Parties of Interest. VICOR agrees that it shall retain primary
responsibility
for reporting all financial interests of Parties of Interest in
accordance with
any and all applicable regulations,
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
7
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
statutes or guidelines and HCRI shall be responsible for obtaining
any required
forms from the Clinical Sites. In compliance with any applicable
regulatory
requirement Parties of Interest shall promptly update forms, as
needed to
maintain their accuracy and completeness during the Study and for
one year after
its completion.
14.
NON-SOLICITATION; FINANCIAL INTEREST IN VICOR.
a. VICOR shall not solicit for employment or employ, at any time
during the
term hereof or for a period of one (1) year thereafter, any person
employed by
HCRI at any time during the term hereof, without the prior written
consent of
HCRI. If VICOR employs a staff member of HCRI without HCRI's prior
written
consent, VICOR agrees to pay a fee of 100% of the individual's
salary or
expected compensation for the first year of service.
b. Neither VICOR nor any affiliate or subsidiary of VICOR shall
grant,
issue or provide or agree to grant, issue or provide any financial
interest,
including any consulting or other fee or stock or other equity, to
any person
employed by HCRI or any immediate family member of any person
employed by HCRI
without the prior written consent of the President and Chief
Executive Officer
of HCRI.
15.
ARBITRATION.
a. The parties shall settle by arbitration any controversy or claim
between
them arising directly or indirectly under this Agreement, whether
based on
contract, tort, fraud, misrepresentation or other legal theory, and
whether or
not arbitration has been expressly referenced elsewhere in a
particular section
or a particular subsection of this Agreement. The arbitration shall
occur in
Boston, Massachusetts under the then current rules and supervision
of the
American Arbitration Association. If the dispute involves a claim
for money in
the amount of $500,000 or less and does not involve any claims
relating to
ownership, use, or disclosure of intellectual property, the
arbitration shall be
before a single arbitrator whom the parties shall select from a
panel of persons
knowledgeable in the therapeutic area addressed by the Trial and
clinical
research; otherwise, the arbitration shall be before three
arbitrators, one
selected by VICOR, one selected by HCRI, and the third selected by
the two
arbitrators so selected. The arbitrator or arbitrators shall not
have the power
to award punitive or exemplary damages. The decision. and award of
the
arbitrator or arbitrators shall be final and binding and the award
rendered may
be entered in any court having competent jurisdiction. The parties
shall each
pay their own attorneys' fees associated with the arbitration, and
shall pay the
other costs and expenses of the arbitration as the rules of the
American
Arbitration Association or the arbitrator provide.
b. Any party may request arbitration to resolve any controversy or
claim,
between them, as provided above, by written notice to the other
proposing an
arbitrator. The other party receiving such written notice shall
have thirty (30)
days in which to agree with such choice of arbitrator or, if three
arbitrators
are required, to propose its arbitrator.
16.
FORCE MAJEURE.
a. Neither party shall be liable for any unforeseeable event beyond
its
reasonable control not caused by the fault or negligence of such
party, which
causes such party to be unable
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
8
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
to perform its obligations under this Agreement, and which it has
been unable to
overcome by the exercise of due diligence.
b. In the event of the occurrence of such a force majeure event,
the party
unable to perform shall promptly notify the other party. It shall
further use
its best efforts to resume performance as quickly as possible and
shall suspend
performance only for such period of time as is necessary as a
result of the
force majeure event.
17.
MISCELLANEOUS.
This Agreement constitutes the entire agreement among the parties,
and all
prior negotiations, representations, agreements and understandings
are
superseded hereby. No agreements amending, altering or
supplementing the terms
hereof may be made except by means of a written document signed by
the duly
authorized representatives of the parties. Any notice required by
this Agreement
shall be given by prepaid, first class, certified mail, return
receipt
requested, to the parties at their addresses set forth above. This
Agreement
shall be governed by and construed in accordance with the laws of
The
Commonwealth of Massachusetts. The invalidity or unenforceability
of any term or
provision hereof shall not affect the validity or enforceability of
any other
term or provision hereof. Failure of either party to enforce a
right under this
Agreement shall not constitute a waiver of that right or the
ability to later
assert that right. The headings in this Agreement are for
convenience of
reference only and shall not alter or otherwise affect the meaning
hereof. This
Agreement shall be binding upon and inure to the benefit of each of
the parties
hereto and their successors and permitted assigns; provided,
however, this
Agreement may not be assigned by either party without the prior
written approval
of the other party. For the purposes of this Agreement, the parties
shall be
deemed to be independent contractors and not employees or agents of
the other.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed
by their duly authorized representatives.
VICOR TECHNOLOGIES INC.
HARVARD CLINICAL RESEARCH INSTITUTE, INC.
By:
By:
----------------------------------
--------------------------------------
Name
Name:
---------------------------------
------------------------------------
Title:
Title:
------------------------------
-----------------------------------
Date:
Date:
-------------------------------
------------------------------------
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
9
--------------------------------------------------------------------------------
EXHIBIT A
SCOPE OF WORK AND BUDGET
------------------------
"Prospective, Multi-Center Study Of The Ability Of The PD2i Cardiac
Analyzer
To Predict Risk Of Ventricular TachyArrhythmic Events Such As,
Sudden
Cardiac Death( SCD), VentricuLar Fibrillation (VF) or Ventricular
Tachycardia
in High Risk Patients"
Protocol # VTI-2003-03
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
--------------------------------------------------------------------------------
PROJECT PARAMETERS:
================================================================================
Number of Patients Enrolled:
900
--------------------------------------------------------------------------------
Number of Sites
30
--------------------------------------------------------------------------------
Enrollment Period (Approximately)::
12 months
--------------------------------------------------------------------------------
Enrollment Rate:
3 patients/site/month
--------------------------------------------------------------------------------
Follow-u. Period/Patient:
12 months
--------------------------------------------------------------------------------
Follow Ups:
6M, 12M
--------------------------------------------------------------------------------
Project Period:
30 months
--------------------------------------------------------------------------------
Estimated Number of Statistical
Tables,
25 tables, 8 figures, 2 listings
Listings,
and Figures to be Prepared by
HCRI for the Final Statistical Anal sis:
--------------------------------------------------------------------------------
Outside Vendors:
Target Health
--------------------------------------------------------------------------------
Estimated Number of DSMB Meetings:
3
--------------------------------------------------------------------------------
Total Number of DSMB reports:
2
--------------------------------------------------------------------------------
Total Number of Endpoint Reports:
2 (1 6M second, 1 12M primary)
--------------------------------------------------------------------------------
Total Number of Annual Safety Reports:
2
--------------------------------------------------------------------------------
Estimated CEC Event Rate:
30%
--------------------------------------------------------------------------------
Estimated Number of Events to be Adjudicated:
270
================================================================================
--------------------------------------------------------------------------------
VICAR PD2i Cardiac Analyzer CTSA (VIC00) (Final)
Date: March 16, 2007
Harvard Clinical Research Institute, Inc. o VICOR Technologies,
Inc.
--------------------------------------------------------------------------------
TASK MATRIX:
-------------------------------------------------------------------------------------------------------------------------
VICOR
HCRI
MFH
TARGET
-------------------------------------------------------------------------------------------------------------------------
CLINICAL DOCUMENT DEVELOPMENT
-------------------------------------------------------------------------------------------------------------------------
Protocol
-------------------------------------------------------------------------------------------------------------------------
Perform literature review
Yes
-------------------------------------------------------------------------------------------------------------------------
Develop statistical plan (including sample size)
Yes
-------------------------------------------------------------------------------------------------------------------------
Develop protocol summary
Yes
-------------------------------------------
