10(fff)
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement ("Agreement") is entered into by and between
Thermal Medical imaging, Inc. ("Sponsor") and Xxxxx Clinic ("Institution"), a
nonprofit institution incorporated under the laws of Massachusetts.
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 Xxxxx X. Xxxxxx, 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 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
b. Exhibit "B" - Budget
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.
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
This estimated period of performance is from 5/1/99 to 4/30/00. However,
the patient enrollment goal for the trial may be reached before or after this
estimated date. The agreement will remain in effect until the accrual for all
clinical sites reaches the goal of 300 malignant patients. 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 B. Sponsor shall make payments based on completed case
report forms for patients enrolled in the trial 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:
Xxxxx Clinic, Inc.
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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 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.
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 Middlesex.
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 State of Massachusetts 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 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: (1) 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 RESULTS OF 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.
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: (1) 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 I 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
This Agreement shall be governed and construed in accordance with the laws of
the State of Massachusetts 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 (3 (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.
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:
The Xxxxx Clinic Research Department
00 Xxxx Xxxx
Xxxxxxxxxx, XX 0 1805
With a copy to Xx. Xxxxx X. Xxxxxx, Xxxxx Clinic, 00 Xxxx Xxxx, Xxxxxxxxxx, XX
00000
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. XXXXX CLINIC
By: /s/ Xxxxx Xxxxxx By: /s/ Xxxxxx Xxxxxxx
Name: Xxxxx Xxxxxx Name: Xxxxxx Xxxxxxx
Title: President Title: VP, Research
Date: 5-18-99 Date: 5/3/99
By: /s/ Xxxxx Xxxxxx
Name: Xxxxx Xxxxxx, M.D.
Title: Principal Investigator
