EXHIBIT 10(uu)
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement ("Agreement") is entered into by and between
Thermal Medical imaging, inc. ("Sponsor") and Providence Hospital of Washington
D.C., 0000 Xxxxxx Xxxxxx, XX, Xxxxxxxxxx X.X., 00000 ("Institution"), a DISTRICT
OF COLOMBIA NONPROFIT institution incorporated under the laws of District of
Columbia.
RECITALS
WHEREAS, the clinical trial contemplated by this Agreement is of mutual interest
and benefit to Institution and to Sponsor, will further the study objectives of
Institution in a manner consistent with it's non-profit, tax exempt health care
institution and may derive benefits for both Sponsor and Institution through the
discovery of new knowledge;
NOW, THEREFORE, in consideration of the premises and mutual covenants herein
contained, the parties hereto agree to the following:
DEFINITIONS
"Monitor" shall mean the individual or firm retained by Sponsor to provide
monitoring services for the Study utilizing Sponsor's Protocol and Study Device,
initially being QBRI International, Inc.
"Principal Investigator" shall be Xxxxxx Xxxx M.D. who is acting as a
representative for the Institution in activities associated with this study.
"Protocol" shall mean the Protocol and Statement of Work as attached hereto as
Exhibit "A">
"Study" shall mean the clinical studies, examinations and collection of patient
data using the Study Device as described in the Protocol, conducted and
collected at the Institution's premises from patients examined by the
Investigator.
"Study Device" shall mean integrated thermal imaging data acquisition system for
breast cancer detection, the interpretive algorithm analysis process and the
clinical evaluation and display device/software which are to be used or
administered during the Study in accordance with the provisions of the Protocol.
"Sponsor Intellectual Property" shall mean all inventions, improvements and
discoveries whether or not covered by intellectual property protection, which
are conceived or made by one or more employees of Sponsor's organization or
sub-contractor hired by Sponsor.
1. CONTENTS AND ORDER OF PRECIDENCE
This Agreement consists of this Agreement and the following documents which
shall be referred to collectively herein as the "Transaction Documents":
a. Exhibit "A"- Protocol and Statement of Work; and
In the event of any conflict between such Exhibits and this Agreement shall
control.
2. PERFORMANCE OF THE STUDY
2.1 Institution shall perform the Study substantially in accordance
with the protocol and the terms and conditions of this Agreement.
Sponsor and Institution may at any time amend the Study and this
Agreement by mutual written consent.
2.2 In the event that the Principal Investigator becomes unable or
unwilling to continue the Study and a mutually acceptable
substitute is not available, both the Institution and the Sponsor
shall have the option to terminate this Agreement. The Principal
Investigator and any and all other persons involved in the
Study (collectively the "Investigator(s) "shall execute the
Investigator Agreement) prior to beginning any activities
associated with the Study.
2.3 Nothing in the Agreement shall be construed to limit the freedom of
the Investigators, whether participants in this Agreement or not,
from engaging in similar studies made independently under other
grants, contracts or agreements with parties other than Sponsor,
provided said investigations are not in conflict or violate the
terms and conditions of this Agreement.
2.4 In performing the Study, Institution and Principal Investigator
shall at times undertake, comply with, and complete the following:
1. The Protocol;
2. This Agreement;
3. Generally accepted standards of good clinical practice;
4. Instructions provided in writing by Sponsor or Monitor;
5. All applicable federal, state and local laws and
regulations applicable to the conduct of the Study and the
performance of clinical investigators generally including
but not limited to the Federal Food, Drug and Cosmetic Act
and regulations of the Food and Drug Administration;
6. Prepare an appropriate patient informed consent document
sufficient to comply with all local, state, and federal
statutory and regulatory requirements and in form
acceptable to each of the parties to initiation of any
procedures required by the Study;
7. Obtain and forward to Sponsor and Monitor evidence of
Institutional Review Board ("IRB") approval of the Study
and the informed consent document prior to beginning the
Study;
8. Obtain and forward to Sponsor and Monitor evidence of
ongoing review of the Study and Informed Consent document
by the IRB at least annually;
9. Obtain and forward to Sponsor and Monitor evidence of IRB
approval of any advertisement used for the Study prior to
the publication or other use of the advertisement;
10. Review the clinical investigators' manual and all updates
provided;
11. Maintain Study and related medical records according to
local, state and federal statutory and regulatory
requirements;
12. Immediately notify Sponsor and Monitor, according to
procedures specified by Monitor, of any and all serious
and/or unexpected adverse events as defined by the Study
and promptly record such events on an appropriate case
report for ("CRF") provided by Sponsor;
13. Promptly notify Sponsor and Monitor of any pregnancy of
any subject enrolled in the Study;
14. Enroll only qualified subjects in the Study as provided in
the Protocol, or as directed by Sponsor and Monitor.
3. MAINTENANCE OF RECORDS AND FORMS
3.1 Institution agrees to fulfill the obligations imposed by Sponsor
for maintenance of records and reports, and those obligations
included in Subpart D of 21 CFR Chapter 1, Responsibilities of
Sponsor and Investigators, a copy of which is provided by Monitor
as part of the study manual.
3.2 Principal Investigator shall complete and return accurate CRF's to
Sponsor as described in the Study. Principal Investigator also
agrees to ensure the data captured on the CRF's is consistent with
the patient medical records, to complete the case report forms in a
timely, coherent, legible fashion, and to have the CRF's completed
in advance of any planned monitoring visits.
3.3 Institution shall retain all records from the Study (including
medical records of enrolled patients) for the period of five (5)
years and will permit inspection by Sponsor or its authorized
representatives of all such records during normal business hours.
During the period of performance and for a reasonable period
thereafter, Sponsor may make copies of and/or extract
non-confidential information from such records at Sponsor's
expense. For purposes of this paragraph, confidential information
shall mean information which identifies a specific patient.
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4. LICENSES AND QUALIFICATIONS
4.1 Principal Investigator shall have and maintain in full force and
effect any and all professional and other licenses, certificates or
documents required to render the services described in this
Agreement and agree to provide copy of these licenses, certificates
or documents to Sponsor or Monitor on request. If any such license
is suspended or revoked during the course of the Principal
Investigator's participation in the Study, Institution agrees to
notify Sponsor and Monitor promptly in writing.
4.2 Principal Investigator represents and warrants that he has not been
barred from conducting clinical studies by the US Food and Drug
Administration or any other applicable governmental regulatory
agency. Institution agrees to immediately notify Sponsor and
Monitor in writing if the Principal Investigator is barred during
the course of the Study.
4.3 Principal Investigator agrees to provide a current curriculum vitae
which is true, complete and accurate up to the start date of this
Agreement, Investigator agrees that Sponsor may supply copies of
the Curriculum Vitae to Monitor, the FDA and any other government
regulatory bodies in connection with the Study.
4.4 Institution represents and certifies that no investigation or study
in which Principal Investigator has been engaged has been
terminated for Principal Investigator's failure to adhere to
protocol, guidelines, or Federal or State regulations.
5. PERIOD OF PERFORMANCE
The estimated period of performance of the Agreement is 2/15/98 through 2/15/99.
This Agreement shall become effective upon the date of the last signature hereto
and shall continue in effect for the full duration of the period of performance
unless sooner terminated in accordance with the provisions of article 2 or 15.
6. REPORTS
Institution shall furnish Sponsor reports, in the form of case report
forms and logs, in such frequency and format as mutually agreed to by the
parties, but in no event less than every 30 days. A final report setting forth
the accomplishments and significant Study findings or lack thereof shall be
prepared by Institution and submitted to Sponsor within 90 days of the
expiration of the Agreement.
7. COSTS, XXXXXXXX AND OTHER SUPPORT
7.1 It is agreed and understood by the parties hereto that, subject to
Article 2, payments shall be made by Sponsor to Institution on a
monthly basis as set forth in Exhibit A. Sponsor shall make
payments based on completed case report forms for patients enrolled
during the prior month in addition to any other amounts mutually
agreed to by parties in Exhibit A.
7.2 Checks shall be made payable to:
7.3 In the event of termination of this Agreement pursuant to Article
15 hereof, Sponsor shall pay all costs directly attributable to the
Study accrued by Institution as of the date of termination,
including all costs directly attributable to the Study accrued by
Institution as of date of termination, including all non-cancelable
obligations, and for all costs associated with patient follow-up as
required by the Protocol of those already enrolled in the Study.
8. PUBLICITY
Neither party shall use the name, trade name, trademark or other designation of
the other party in connection with any products, promotion or advertising
without the prior written permission of the other party.
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9. PUBLICATIONS
The Study to be performed under this Agreement is part of a Multi-Center
Collaborative project. The Institution recognizes that the results generated by
this Study may have added scientific significance when combined and published
together with data generated by other centers involved in the project.
Accordingly, Institution expressly acknowledges that the right to publish the
combined results of the collaborative project belongs to Sponsor. The
Institution shall have the rights to publish the results of this Study but
agrees to refrain from publishing until the project is complete, the data
analyzed and the combined results submitted for publication, and until the
Sponsor has received final Food and Drug Administration Pre-Market approval or
disapproval. Sponsor shall notify the Institution within 30 days of notification
from FDA of their decision.
10. CONFIDENTIALITY
10.1 During the term of this Agreement, Sponsor expects to provide
Institution with the Study Device, Protocol, and other information,
data and materials related thereto (collectively, the "confidential
Property") which Sponsor considers confidential or proprietary in
nature and which shall be prominently marked or identified as
confidential or proprietary. Institution shall receive and hold
such Confidential Property in confidence and agrees to prevent
disclosure of said Confidential Property to all parties other than
those involved in conducting the Study, in the manner Institution
treats its own similar information.
10.2 Institution shall not consider information disclosed to it by
Sponsor to be confidential which: (1)is now common knowledge or
subsequently becomes such through no breach of this Agreement (2)
is rightfully in Institution's possession prior to Sponsor's
disclosure as shown by written records (3) is disclosed to
Institution by an independent third party that is not under a
separate confidentiality agreement relating thereto; or (4) is
independently developed by or for Institution without benefit of
confidential information received from Sponsor.
11. INTELLECTUAL PROPERTY
Notwithstanding anything to the contrary in this Agreement, all right, title and
interest to any intellectual property, including without limitation inventions,
improvements, results, data and discoveries, that arise from, relate to or are
direct and specific result of performance of the Protocol and is directly
related to the Study Device, shall belong to the Sponsor.
12. ARBITRATION
Any controversy or claim between the parties arising out of or relating to this
agreement, or a breach thereof, which cannot be resolved relating to this
agreement, or a breach thereof, which cannot be resolved by mutual agreement
shall be settled by binding arbitration conducted by a single arbitrator in
accordance with the commercial arbitration rules of the American Arbitration
Association. Any judgment upon the award rendered by the arbitrator may be
entered in any court having jurisdiction thereof, each such arbitration shall be
held in the county of -------------------.
All federal and state substantive and procedural laws applicable to this
agreement relating to arbitration of conflict shall be fully complied with by
the parties.
Unless the parties otherwise agree, each party may conduct discovery prior to
any arbitration hearing in accordance with the District of Columbia rules of
civil procedure and evidence. Additionally, there shall be no evidence by
affidavit allowed, and each party shall disclose a list of all documentary
evidence to be used, a list of all witnesses and experts to be called by the
party at least 20 (twenty) days prior to the arbitration hearing.
13. EXPORT
Sponsor agrees that it will at all times be in compliance with the United States
government export regulations and laws and that Any sub-Sponsor agreement will
require that the sub-sponsor Agreement will require that the sub-Sponsor
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is in compliance with these regulations and laws. Sponsor asserts that it is not
now doing business with any country to which the United States government
prohibits export of products under consideration in this Study.
14. TERMINATION
14.1 If a party hereto breaches a material term, covenant or condition
of the Transaction Documents or this Agreement, the non-breaching
party may terminate this Agreement. Prior to termination, the
non-breaching party shall provide written notice of default, which
shall inform the breaching party of the facts and circumstances
upon which such default is based and which shall provide the
breaching party with 30 (thirty) days in which to cure such breach
or such longer period as the parties may agree or as applicable law
may require. If such breach is not cured within the specified time
period, the non-breaching party may terminate this Agreement by
providing written notice of such termination to the defaulting
party.
14.2 This Agreement may be terminated immediately by Sponsor upon
written notice to Institution in the event of any adverse patient
reaction. Upon receipt of a termination notice from Sponsor, the
Institution shall stop enrolling and treating patients under the
Study to the extent consistent with generally accepted standards of
good medical practice and patient safety.
14.3 Termination of this Agreement by either party for any reason shall
not effect the rights and obligations of the parties accrued prior
to the effective date of termination
14.4 Principal Investigator's participation in the Study will
automatically terminate upon receipt of notice that:
1. Any license required to be held by Investigator is suspended or
revoked; or
2. Investigator has been debarred from conducting clinical studies
by the US Food and Drug Administration.
14.5 In addition to termination under 16.1 and 16.2, Sponsor may
terminate Institution's participation in the Study upon written
notice to Institution in the event that:
1. Sponsor terminates the Study; or
2. Overall study enrollment goals have not been met, even if
Investigator's individual enrollment has not been reached.
14.6 Institution may terminate participation in the Study if
Investigator becomes unwilling or unable to serve, provided
Sponsor is provided at least thirty (30) days advance written
notice, in order to give Sponsor an opportunity to identify and
engage a replacement Investigator.
14.7 Upon termination of this Agreement: (I) the Investigator shall
stop enrolling patients in the Study; (ii) shall cease conducting
procedures on patients already enrolled in the Study, except to the
extent such procedures are medically necessary and permissible, and
(iii) both Institution and Investigator shall return to Sponsor any
and all Confidential Property which is in Institution's,
Investigator's, or any of their employee's or agent's possession or
control.
15. WARRANTIES
15.1 Institution agrees ton perform the Study in accordance with the
prevailing professional standards.
15.2 INSTITUTION MAKES NO WARRANTIES FOR ANY PURPOSE WHATSOEVER,
EXPRESS OR IMPLIED, AS TO THE STUDY OR THE RESUTLS FO THE STUDY,
INCLUDING THE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
OF THE STUDY OR THE RESULTS OF THE STUDY UNDER THIS AGREEMENT.
Neither the Principal Investigator, Sponsor, nor any other person
is authorized to give any such warranty in the name or on behalf of
the Institution.
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15.3 Sponsor agrees that it will not rely solely on technical
information provided by the Institution or the Principal
Investigator in developing any invention or product, but will
independently test, analyze and evaluate all inventions and
products prior to manufacture and distribution of such inventions
and products.
15.4 Neither Institution or Investigator shall make any warranty or
representation, including but not limited to a warranty or
representation of the efficacy of the Study Device, without the
express permission of the Sponsor, and Sponsor will not be liable
for any unauthorized warranty or representation made by
Investigator.
16. INSURANCE AND INDEMNIFICATION
16.1 At all times during the conduct of the Study under this Agreement,
Institution agrees to maintain at its sole cost and expense
appropriate and adequate professional and general commercial
liability insurance, such protection being applicable to and
covering negligent acts/omissions of officers, employees and agents
while acting within the scope of their employment by Institution,
on an occurrence made basis in single limit coverage of not less
than One Million Dollars ($1,000,000) per claim or incident and One
Million Dollars ($1,000,000) annual aggregate for death, bodily
injury, illness or property damage to support indemnification
obligations of Institution in Section 18.4 hereof. A Certificate
evidencing such policy shall be delivered to Sponsor upon written
request.
16.2 Sponsor will hold harmless, indemnify and defend Institution it's
trustees, and agents from demands, claims or costs of judgments
that may be made or instituted against any of them by reason of
injury or death to any person, or damage to property arising out of
or related to performance of the study, provided however, Sponsor
will have no liability for loss or damage resulting from: (I)
failure to adhere to the protocol or Sponsor's written instructions
concerning use of the study device, (ii) Failure to comply with
applicable FDA or other government requirements, or (iii)
negligence or willful malfeasance by Providence, it's trustees,
officers, agents or employees.
16.3 At all times during the study, Sponsor agrees to maintain at it's
sole cost and expense a policy or program of comprehensive general
liability insurance or self-insurance on an occurrence made basis
in single limit coverage of not less than one million dollars
($1,000,000) per incident, and an annual aggregate of 1 million
dollars ($1,000,000), for death, bodily injury, illness or property
damage to support the indemnification obligations assumed herein.
Sponsor shall maintain such comprehensive general liability
insurance during the period that the Study or any modification
thereof is being administered, manufactured, sold or distributed to
humans by Sponsor and a reasonable period thereafter which in no
event shall be less than two years. A Certificate evidencing the
comprehensive general liability policy shall be delivered to
Providence Hospital upon request.
16.4 Institution agrees to hold harmless, indemnify and defend Sponsor
from all liabilities, demands, expenses, and losses arising out of
and related to Institution's or Principal Investigator's gross
negligence or willful misconduct.
17. INDEPENDENT CONTRACTOR
17.1 Institution is an independent contractor and not an agent, joint
venture partner of Sponsor.
17.2 Investigator is a member of Institution which is an independent
contractor of Sponsor for all purposes and not an employee, as that
term is understood for purposes of federal and state law. Nothing
in this Agreement shall be deemed to constitute a partnership or
joint venture between Sponsor and Institution, nor shall anything
in this Agreement be deemed to constitute Investigator or Sponsor
as the agent of the other. Neither Investigator, Institution nor
Sponsor shall become liable or bound by an representation, act or
omission whatsoever of the other, except to the extent expressly
provided in this Agreement.
18. GOVERNING LAW
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This Agreement shall be governed and construed in accordance with the laws of
the District of Colombia as adjudicated by a court of competent jurisdiction.
19. ATTORNEY'S FEES
In any action on or concerning this Agreement, the prevailing party shall be
awarded its reasonable attorney's fees, costs and necessary disbursements, to be
paid by the non-prevailing party.
20. ASSIGNMENT
Neither party shall assign it's rights or duties under this Agreement to another
without the prior written consent of the other party, except to any party
succeeding to substantially all of the business interests of the assigning
party.
21. INSPECTION AND ACCESS
Sponsor's authorized representatives and regulatory authorities may examine and
inspect the Institution's facilities as required for performance of the Study
and inspect and copy all data and work products relating to the Study.
Inspections will be conducted during regular business hours upon reasonable
notice and to the extent permitted by law and until the Sponsor has received
final Food and Drug Administration Pre-Market approval or disapproval.
22. RESEARCH MATERIALS
22.1 Institution acknowledges that the Study Device and all other
property and materials provided to the Investigator by Sponsor in
connection with the Study is to be used only for research purposes
in connection with the Study. Institution and Investigator shall
have no license or authority to use any such item in any other
context or for any other purpose.
22.2 Institution also agrees to use the Study Device only in the space
approved by Monitor or Sponsor in accordance with documentation
provided by Monitor or Sponsor. Investigator agrees to maintain
adequate records of the use of the Study Device. In addition,
Institution agrees to return Study Device and all other property
and materials being provided to Investigator by Sponsor in
connection with the Study upon termination or completion of the
Study.
23. WAIVER AND SEVERABILITY
23.1 No waiver by either party of any breach of any provision hereof
shall constitute a waiver of any other breach of that or of any
other provision hereof.
23.2 In the event a court or governmental agency of competent
jurisdiction holds any provision of this Agreement to be invalid,
such holding shall have no effect on the remaining provisions of
this Agreement, and they shall continue in full force and effect.
Upon such holding, the parties shall, within a reasonable period of
time, determine whether the severed provision(s) detrimentally and
materially affect the obligations or performance of either or both
parties. If so affected, the parties shall, within a reasonable
period of time, negotiate in good faith to modify this Agreement to
relieve such effects. If such negotiations do not result in
mutually agreeable modifications to this Agreement, wither effected
party may terminate this Agreement upon providing the other party
with thirty (30) days written notice of such termination.
23.3 Sections 3.3, 6, 7.3, 9,10, 11,12,15,20,22 and this 23.3 shall
survive the termination of this Agreement for any and all reasons
whatsoever.
24. AGREEMENT MODIFICATION
This Agreement may be modified or amended, including extension of the term of
this Agreement, at any time only by the written concurrence of both parties.
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25. NOTICES
Any notices given under this Agreement shall be in writing and delivered to the
following addresses by return receipt mail, postage prepaid, or by overnight
courier service. Such notices shall be effective upon the third business day
following mailing, if by mail, or upon receipt, if by courier.
For Sponsor:
Thermal Medical Imaging, Inc.
0000 Xxxxx Xxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx Xxxxx, XX 00000
For Institution:
With a copy to Xx. Xxxxxx Xxxx
For Monitor:
QBRI International, Inc.
0000 Xxxxx 00xx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Xxx Xxxxx
26. THIRD PARTY RIGHTS
This Agreement shall not create any rights, including without limitation third
party beneficiary rights, in any person or entity not a party to this Agreement.
27. ENTIRE AGREEMENT
This Agreement constitutes the entire understanding between the parties hereto
and there are no collateral, oral or written agreements or understandings. This
Agreement supersedes any prior oral or written agreements or understandings
between the parties.
IN WITNESS WHEREOF, the parties have executed this Agreement in two or more
counterparts, each as an original and all together as one instrument as of the
date of last signature below written.
THERMAL MEDICAL IMAGING, INC. PROVIDENCE HOSPITAL
By: /s/ Xxxxxx Xxxxxxxxx By: /s/ Xxxxxx X. Xxxxxx, M.D.
----------------------------------------- --------------------------------------
Name: Xxxxxx Xxxxxxxxx Name: Xxxxxx X. Xxxxxx, M.D.
--------------------------------------- ------------------------------------
Title: Director, Marketing & Reg. Affairs Title: Vice President, Medical Affairs
-------------------------------------- -----------------------------------
Date: 14 February 1998 Date: February 13, 1998
--------------------------------------- ------------------------------------
By: /s/ Xxxxxx X. Xxxx, M.D.
--------------------------------------
Name: Xxxxxx X. Xxxx, M.D.
------------------------------------
Title: Principal Investigator
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EXHIBIT A
PROTOCOL AND STATEMENT OF WORK
[SEE EXHIBIT 10(vv)]
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EXHIBIT B
THERMAL MEDICAL IMAGING BUDGET
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THERMAL MEDICAL IMAGING BUDGET
One Time Expenses
Build Out $ 5,000.00
Principal Investigator $ 2,000.00
Co-Investigator $ 1,500.00
Co-Investigator $ 1,500.00
Total $ 10,000.00
Providence Hospital Cost
Calculation
Study Co-ordinator $ 48,000.00 annual
Benefits $ 9,600.00 annual
Phone $ 4,800.00 annual
Square footage costs
Capital $ 9.50 96 cost
Capital $ 2.85 96 cost
Maintenance $ 1.59 96 cost
Plant/Ops $ 14.58 96 cost
Housekeeping $ 8.39 96 cost
Sq. Foot Total $ 36.91
Total Sq. Feet $ 320.00
Annual Cost of Space $ 11,811.20
Total Direct Cost $ 74,211.20 annual
A&G $ 4,378.46 $0.06
Annual Direct & Indirect $ 78,590.00
Patients per month 20
Cost/patient before med. records $ 327.00
Medical Records $ 21.00
Total Costs/patient $ 348.00
Expected patients in 8 months $ 160.00
TOTAL BUDGET $ 55,728.00
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