EXHIBIT 10(qq)
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement ("Agreement") is entered into by and
between THERMAL MEDICAL IMAGING, INC. ("Sponsor") and the Health Research
Association, 1640 Xxxxxxx Xxxxxxx, 0xx Xxxxx, ("Institution"), a California
nonprofit educational institution incorporated under the laws of the State of
California.
RECITALS
WHEREAS, the clinical trial contemplated by this Agreement is of mutual
interest and benefit to Institution and to Sponsor, will further the
instructional, scholarship and study objectives of Institution in a manner
consistent with its status as a nonprofit, tax-exempt, educational
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 Study utilizing Sponsor's Protocol and Study
Device, initially being QBRI International, Inc.
"Principal Investigator" shall be Xxxxxxx X. Xxxxxxxxx, 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 screening, 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.
"Institution Intellectual Property" shall mean individually and
collectively all inventions, improvements and discoveries, whether or not
covered by intellectual property protection, which are conceived or made by
one or more employees of Institution in conducting the Study and which are
not Joint Intellectual Property or Sponsor's Intellectual property.
"Joint Intellectual Property" shall mean individually and collectively
all inventions, improvements and discoveries, whether or not covered by
intellectual property protection, which are conceived or made jointly by one
or more employees of Sponsor and Institution.
1. CONTENTS AND ORDER OF PRECEDENCE
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
b. Exhibit "B" - Confidentiality Agreement dated November 7, 1996.
In the event of any conflict between such Exhibits and this Agreement, the
terms of this Agreement shall control.
2. PERFORMANCE OF THE STUDY
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2.1 Institution shall perform the Study substantially in accordance
with the protocal 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 Principle Investigator and any and all other
person involved in the Study (collectively the "Investigator(s)" shall
execute the Confidentiality Agreement substantially in the form attached
hereto or Exhibit "B", (the "Confidentiality Agreement") prior to beginning
any activities associated with the Study.
2.3 Nothing in the Agreement shall be construed to limit the freedom of
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 and the
Confidentiality Agreement.
2.4 In performing the Study, Institution and Principal Investigator
shall at all 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, and
thereafter to obtain such written consent from each patient or
authorized representative prior 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' brochure and all updates as
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 form ("CRF") agreed to by the parties;
13. Promptly notify Sponsor and Monitor of any pregnancy of any subject
enrolled in the study; and
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 a part of the site study manual.
3.2 Principal Investigator shall complete and return accurate CRFs to
Sponsor as described in the Study. Principal Investigator also agrees to
ensure the data captured on the CRFs are consistent with the patient medical
records, to complete the case report forms in a timely and coherent, legible
fashion, and to have the CRFs completed in advance of any planned monitoring
visits.
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3.3 Institution shall retain all records from the Study (including
medical records of enrolled patients) for the period of 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
nonconfidential information from such records at Sponsor's expense. For
purposes of this paragraph, confidential information shall mean information
which identifies a specific patient.
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 a copy of these licenses, certificates or documents to Sponsor and
Monitor upon 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 agency 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 this Agreement is 9/1/97 through
9/1/98. This Agreement shall become effective upon the date of 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 ninety (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, total costs to the Sponsor hereunder shall not exceed the amount
of $385,218.75. Payment shall be made by Sponsor according to the schedule
set forth in Exhibit "A".
7.2 Checks shall be made payable to the Health Research Association,
Federal ID No. 00-0000000, and sent to:
Health Research Association
Attn. Xxxxxxx Xxxxxxxxx
0000 Xxxxxxx Xxxxxx, 0xx Xxxxx
Xxx Xxxxxxx, XX 00000
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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 dare of termination, including noncancellable
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.
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 the
Sponsor. The Institution shall have the right to publish the results of this
Study but agrees to refrain from publishing until the Collaborative 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 the 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 in writing as confidential or propriety.
Institution shall receive and hold such Confidential Property in confidence
and agrees to prevent disclosure of said Confidential Property to employees
and agents of Institution, other than those involved in conducting the Study,
and to all third parties, in the manner Institution treats its own similar
information.
10.2 Institution shall not consider information disclosed to it by
Sponsor 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
11.1 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 the direct and specific result of performance of
the Protocol and is directly related to the Study Device, shall belong to the
Sponsor and shall not be considered Institution Intellectual Property.
11.2 All rights and title to any other intellectual property developed
or conceived under this Study (which excludes all other study sites of this
Multi-Center Collaborative project) shall be considered Institution
Intellectual Property, shall belong to Institution and shall be subject to
the terms and conditions of this Agreement.
11.3 Institution will promptly notify Sponsor of any and all Institution
Intellectual Property conceived or made in the performance of work under this
Agreement. Sponsor shall, upon reviewing such notification, determine whether
to request Institution to file, prosecute and maintain any patent application
or application for other intellectual property protection, domestic or
foreign, in Institution's name and whether such property constitutes
Institution
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Intellectual Property. Sponsor shall bear all reasonable costs incurred in
connection with preparation, filing, prosecution and maintenance directed to
Institution Intellectual Property. Institution shall keep Sponsor advised as
to all developments with respect to such applications and Sponsor shall be
given an opportunity to review and comment thereon. If Institution and
Sponsor are unable to agree on whether intellectual property conceived or
made by Institution under 11.2 constitutes Institution Intellectual Property,
Institution may appeal to arbitration under Section 14.
12. JOINT OWNERSHIP INTELLECTUAL PROPERTY
All rights and title to Joint Intellectual Property under the Study shall
belong jointly to Sponsor and Institution and shall be subject to the terms
and conditions of this Agreement. The parties hereto shall promptly notify
each other of any Joint Intellectual Property conceived or made in the
performance of work under this Agreement. The parties shall, upon reviewing
such notification, determine whether to and which party should file,
prosecute and maintain any patent application or application for other
intellectual property protection, domestic or foreign, jointly in Sponsor's
and Institution' names. The parties shall mutually determine the division of
costs incurred in connection with such preparation, filing, prosecution and
maintenance directed to said Joint Intellectual Property. The applying party
shall keep the other party advised as to all developments with respect to
such applications and the non-applying party shall be given an opportunity to
review and comment thereon.
13. GRANT OF RIGHTS
Institution grants Sponsor a time-limited first right to negotiate a
commercial option or worldwide, royalty-bearing license, with the right to
sublicense, to Institution Intellectual Property and to Institution's
interest in Joint Intellectual Property. Such first right must be exercised
within six (6) months after disclosure of Institution Intellectual Property
or disclosure of Joint Intellectual Property in accordance with Articles 11
and 12 above. Institution and Sponsor shall negotiate the terms of any such
license in good faith.
14. ARBITRATION
ANY CONTROVERSY OR CLAIM BETWEEN THE PARTIES ARISING OUT OF OR 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 LOS ANGELES, CALIFORNIA.
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 CALIFORNIA 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 TWENTY (20) DAYS PRIOR TO THE ARBITRATION HEARING.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, EACH PARTY KNOWINGLY, VOLUNTARILY,
AND INTENTIONALLY WAIVES ANY RIGHT TO CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE
DAMAGES REGARDLESS OF THE FORUM FOR THE PROCEEDINGS. THE PROVISIONS OF THIS
SECTION SHALL SURVIVE THE TERMINATION OF THIS AGREEMENT FOR ANY REASON
WHATSOEVER.
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15. 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 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.
16. TERMINATION
16.1 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 thirty (30) 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.
16.2 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.
16.3 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.
16.4 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 during the course of the Investigator's participation in the Study; or
2. Investigator has been debarred from conducting clinical studies by the
US Food and Drug Administration.
16.5 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.
16.6 Institution may terminate participation in the Study if it becomes
unwilling or unable to continue 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.
16.7 Upon termination of this Agreement: (i) the Investigator shall stop
enrolling patients into 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.
17. WARRANTIES
17.1 Institution agrees to perform the Study in accordance with prevailing
professional standards.
17.2 INSTITUTION MAKES NO WARRANTIES FOR ANY PURPOSE WHATSOEVER, EXPRESS
OR IMPLIED, AS TO THE STUDY OR THE RESULTS OF THE STUDY, INCLUDING THE
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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 of or on behalf of Institution.
17.3 Sponsor agrees that it will not rely solely upon technical
information provided by 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.
17.4 Neither Institution nor Investigator shall make any warranty or
representations, including but not limited to a warranty or representation of
the efficacy of the Study Device, without the express written permission of
Sponsor and Sponsor will not be liable for any unauthorized warranty or
representation made by Investigator.
18. INSURANCE AND INDEMNIFICATION
18.1 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 the indemnification
obligations of Institution in Section 18.4 hereof. A Certificate evidencing
each such policy shall be delivered to Sponsor upon request.
18.2 Sponsor agrees to hold harmless, indemnify and defend Los Angeles
County, Institution, it's trustees, officers 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
and related to performance of 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 Institution, it's trustees,
officers, agents or employees, but only to the extent that such demands,
claims or judgments are due to the negligence or will full malfeasance of
Institution, its trustees, officers, agents or employees.
18.3 At all times during this Study, Sponsor agrees to maintain at its
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 ($1,000,000) per incident and
One Million Dollars ($l,000,000) annual aggregate 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 the Sponsor and
a reasonable period thereafter which in no event shall be less than two (2)
years. A Certificate evidencing the comprehensive general liability policy
shall be delivered to Institution upon request.
18.4 Institution agrees to hold harmless, indemnify and defend Sponsor
from all liabilities, demands, damages, expenses, and losses arising out of
and related to Institution's or Principal Investigator's gross negligence or
willful misconduct.
19. INDEPENDENT CONTRACTOR
19.1 Institution is an independent contractor and not an agent, joint
venture or partner of Sponsor.
19.2 Investigator is an employee 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 any representation,
act or omission whatsoever of the other, except to the extent expressly
provided in this Agreement.
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20. GOVERNING LAW
This Agreement shall be governed and construed in accordance with the laws of
the State of California as adjudicated by a court of competent jurisdiction.
21. ATTORNEYS' FEES
In any action on or concerning this Agreement, the prevailing party shall
awarded its reasonable attorneys' fees, costs and necessary disbursements, to
be paid by the nonprevailing party.
22. ASSIGNMENT
Neither party shall assign its 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.
23. INSPECTION AND ACCESS
Sponsor's authorized representatives and regulatory authorities may examine
and inspect the Institution's facilities 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.
24. RESEARCH MATERIALS
24.1 Institution acknowledges that the Study Device and all other
property and materials being provided to 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.
24.2 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 all other property and materials being provided to Investigator by
Sponsor in connection with the Study upon termination or completion of the
Study.
25. WAIVER AND SEVERABILITY
25.1 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.
25.2 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, either effected party may
terminate this Agreement upon providing the other party with thirty (30) days
written notice of such termination.
25.3 Sections 3.3, 6, 7.3, 9, 10, 11, 12, 13, 14, 17, 22, 24 and this
25.3 shall survive the termination of this Agreement for any and all reasons
whatsoever.
26. 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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27. 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
Attention: Xxxx Xxxxx
For Institution:
Health Research Association
Attn: Chief Operating Officer
0000 Xxxxxxx Xxxxxx, 0xx Xxxxx
Xxx Xxxxxxx, XX 00000
Copy to: Xx. Xxxxxxx X. Xxxxxxxxx
For Monitor:
QBRI International, Inc.
0000 Xxxxx 00xx Xxxxxx
Xxxxxxxxx, XX 00000
703.276.0400
703.243.9746(facsimile)
28. 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.
29. 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 Agreement
or understanding 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. HEALTH RESEARCH ASSOCIATION
By: /s/ Xxxxxxx Xxxxx, Jr. By: /s/ Xxxxx X. Xxxxxxxx.
---------------------------- ----------------------------
Name: Xxxxxxx Xxxxx, Jr. Name: Xxxxx X. Xxxxxxxx
---------------------------- ----------------------------
Title: Vice President of Operations Title: President and CEO
---------------------------- ----------------------------
Date: 8/12/97 Date: 9-16-97
---------------------------- ----------------------------
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By /s/ Xxxxxxx Xxxxxxxxx
----------------------------
Name: Xxxxxxx Xxxxxxxxx
----------------------------
Title: Principle Investigator
----------------------------
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EXHIBIT A
PAYMENT SCHEDULE
In accordance to the budget detail sheet set forth herein, payments will be
made to:
Health Research Association
Attn. Xxxxxxx Xxxxxxxxx
0000 Xxxxxxx Xxxxxx, 0xx Xxxxx
Xxx Xxxxxxx, XX 00000
Invoices for work performed shall be sent to:
Thermal Medical Imaging
Attn. Xxxx Xxxxx
0000 Xxxxx Xxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx Xxxxx, XX 00000
Payments will commence within thirty (30) days from the receipt of a detailed
invoice following the installation of the first device at either Xxxxxx
Cancer Hospital or Los Angeles County General Hospital. Initial payment
shall be in the amount of $48,596.75.
Subsequent payments shall be made monthly following a detailed invoice in the
amount of $30,602.
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EXCHANGE OF CONFIDENTIAL INFORMATION
This Agreement, made and entered by and between Thermal Medical Imaging,
Inc., a Nevada Corporation, with a place of business at 0000 Xxxxx Xxxxxxxxx
Xxxx, Xxxxx 000, Xxxxxxxxxx Xxxxx, XX 00000 (hereinafter referred to as TMI),
and Heath Research Association, a California, non-profit corporation with a
place of business at 0000 Xxxxxxx Xxxxxx, 0xx Xxxxx, Xxx Xxxxxxx, XX 00000
(hereinafter referred to as HRA), all or each of which shall also hereinafter
be referred to as "party" or "parties" respectively, and is effective on the
date of last signature hereto.
RECITALS
For the mutual benefit of both parties, each party wishes to disclose to
and/or to receive from the other certain technical data, information, ideas
and documents to be used in conjunction with the project as described in the
letter dated 31 October 1996 from TMI to Xx. Xxxxx Xxxxxxxx and attached
hereto as Attachment 1 (hereinafter "Project"), and which may or may not have
been patented or constitute bases of patentable inventions, but which the
disclosing party nevertheless considers to be Confidential and so indicates
by an appropriate legend, marking, stamp or other positive identification.
Such information, data and ideas shall hereinafter be identified as
"Confidential Information."
AGREEMENTS
Now therefore, the parties do hereby mutually agree that:
1. Confidential Information as defined above includes information or
documents whether or not they qualify as "trade secrets" under applicable
Federal or state law.
2. Each party shall receive and hold such Confidential Information in
confidence and agrees to use its reasonable efforts to prevent unauthorized
disclosure to third parties of said Confidential Information in the same
manner the receiving party uses to protect its own similar information,
provided, however, that neither party shall be liable for use or disclosure
of any Confidential Information if the same:
a. was in the public domain at the time it was disclosed;
b. entered the public domain through no fault of the receiving party
subsequent to the time it was communicated by the disclosing party;
c. was in the receiving party's possession free of any obligation of
confidence at the time it was communicated by the disclosing party;
d. was rightfully communicated to the receiving party by a third party
free of any obligation of confidence subsequent to the time it was
communicated by the disclosing party;
e. was developed by employees or agents of the receiving party without
reference to any information that the disclosing party has communicated to
any third party.
3. If Confidential Information is disclosed, and such information has
importance with respect to intellectual property, such information shall be
reduced to writing promptly by the disclosing party and every page shall be
clearly identified with the legend described above. Such writing shall be
delivered to the receiving party within thirty (30) days after the
disclosure thereto of said Confidential Information.
4. No Confidential Information disclosed pursuant to this Agreement shall be
used, duplicated or disclosed for purposes other than contemplated by the
Project indicated above without the prior written approval of the
disclosing party.
5. No license under any patent or patent application is granted to either
party either directly or indirectly by this Agreement, nor are any rights
of ownership in the Confidential Information granted by this Agreement.
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6. This Agreement shall remain in force for a period of three (3) years. This
Agreement may be terminated by either party with a thirty (30) day prior
written notice to the other party.
7. Confidential Information shall be disclosed only on a need-to-know basis to
personnel of the receiving party.
8. If the Confidential Information is reproduced in whole or part, the
reproduction shall carry a Confidential notice or legend similar to that
which appears on the original.
9. Nothing in this Agreement shall grant to either party the right to make
commitments of any kind, for or on behalf of the other party.
10. This Agreement is not intended to be, nor shall it be considered as, a
"team" arrangement, joint venture, partnership, or other formal business
organization, and unless otherwise agreed, neither party shall have the
right or obligation to share any of the profits or bear any of the risks or
losses of the other party. At all times the parties shall remain
independent contractors with each responsible for its own employees and
representatives. Each party assumes no responsibility to the other for
costs, expenses, risks and liabilities associated with the research,
development, exchange and use of each other's Confidential Information.
11. No rights or obligations other than those expressly recited herein are to
be implied from this Agreement, including any requirement that either party
contract with the other for the procurement of any products, services or
data resulting from this Agreement.
12. Each employee who has had or is granted access to the other party's
Confidential Information shall be informed of the obligation to protect the
Confidential Information of such other party from unauthorized use or
disclosure as herein provided.
13. When this Agreement is terminated as herein provided, or if the
Confidential Information received hereunder is no longer required by the
receiving party, whichever occurs first, then unless otherwise agreed in
writing by the parties, and as directed by the disclosing party, all copies
of the disclosing party's Confidential Information in the possession of the
receiving party shall be returned or destroyed. The receiving party shall
notify the disclosing party in writing when such return or destruction has
been accomplished.
14. This Agreement is deemed to be made under and shall be construed in all
respects in accordance with the Law of the State of California.
15. Each party shall designate personnel for disclosure and receipt of any
Confidential Information hereunder, and all such Confidential Information
shall be addressed to such designated personnel when delivered to the other
party. Such designation of personnel may be amended by letter addressed to
the person who executed this Agreement on behalf of the other party.
The following personnel are initially designated for disclosure and/or
receipt of Confidential Information under this Agreement.
TMI: Health Research Association
Xxxxxxx Xxxxx Xxxx Xxxxx, COO
Xxxxxxx Xxxx ------------------------------
Xxxxxx Xxxxxxxxx ------------------------------
Dr. Xxxxxxx Xxxxxxxxx
16. Neither party shall have any liability for any activity of the other party
in using Confidential Information provided under this Agreement. A
receiving party shall indemnify and hold the disclosing party harmless from
and against any loss, cost or liability arising out of any claims or cause
of action for loss, harm or damage to property or for injury to or death of
persons caused or resulting from any use by a receiving party of
Confidential Information.
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17. This Agreement supersedes all prior understandings and communications
between the parties on the subject matter of this Agreement and shall apply
in lieu of and notwithstanding any specific legend or statement associated
with any information or data exchanged between parties.
Executed for the parties by their respective representatives who are duly
authorized to execute this Agreement.
TMI, Inc. Heath Research Association
/s/ Xxxxxxx Xxxxx /s/ Xxxxx X. Xxxxxxxx
---------------------- -----------------------
(Signature) (Signature)
Xxxxxxx Xxxxx Xxxxx X. Xxxxxxx
---------------------- -----------------------
(Name) (Name)
VP of Operations President and CEO
---------------------- -----------------------
(Title) (Title)
8/12/97 9-16-97
---------------------- -----------------------
(Date) (Date)
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