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EXHIBIT 10.1
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REDACTED COPY
Portions of the full unredacted copy of this agreement is the subject
of a request for confidential treatment. Confidential portions have been
omitted and have been filed seperately with the Securities and Exchange
Commission.
CLINICAL TRIALS AGREEMENT
This Agreement is entered into by and among (Information omitted and
filed seperately subject to a request for confidential treatment)
("Institution"), (Information omitted and filed seperately subject to a request
for confidential treatment)("Principal Investigators") and Analytical
Biosystems Corporation, a Rhode Island corporation with its principal office and
place of business at 00 Xxxxxx Xxxx, Xxxxxxx, XX 00000-0000. ("Analytical
Biosystems").
WITNESSETH:
WHEREAS, the research study contemplated by the Agreement (the "Study") is
of mutual interest and benefit to the Institution and to Analytical Biosystems.
WHEREAS, the Protocol entitled "A Randomized Trial Comparing Empiric
Therapy versus Chemotherapy Directed by In Vitro Sensitivity Testing in Patients
with Carcinoma of Unknown Primary Site" dated July 14, 1995, which is attached
hereto as Exhibit A and incorporated herein by reference, including any future
amendments or revisions thereto ("Protocol"), which will guide the performance
of the Agreement, has been accepted by Analytical Biosystems, and the
Institution and the Principal Investigators each warrant that they are fully
able to perform the Study in a professional, competent manner with strict
adherence to its terms and each of them will utilize its best efforts to do so.
The study shall be considered proprietary research and development
activities of Analytical Biosystems Corporation and undertaken and performed on
a work for hire basis on its behalf by Institution. The services of the
Principal Investigators are included in the fee to Institution as provided in
Section 4 of this agreement.
NOW THEREFORE, the parties hereto agree as follows:
1. SCOPE OF WORK
The Principal Investigators and the Institution shall carry out the Study
set forth in the Protocol in accordance with this Agreement. The Principal
Investigators and the Institution will recruit and coordinate the sites
required to complete the study according to the proposed time schedule.
The Institution and the Principal Investigators also agree to provide the
following services for this study:
1) Biostatistical/Medical Writing
a. Protocol design and writing
b. Creation of case report forms
c. Study analysis
d. Manuscript preparation
2) Regulatory Support
a. IRB coordination
b. Reporting of Serious Adverse Events to IRB(s)
3) Project Management
4) Study Coordination
a. Tissue sample shipping
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b. Notification to enrolling physicians of FCA results and
chemotherapy selection
5) Data collection/completion of Case Report Forms
a. Centralized data collection and completion of CRFs
b. Coordination of obtaining original scans/films for central
review when necessary
c. Coordination of collection of Quality of Life assessments
on-study and through long-term follow-up period when required
d. Reporting of Serious Adverse Events directly to Analytical
Biosystems
e. Weekly accrual reports to Analytical Biosystems
2. PRINCIPAL INVESTIGATORS
The Principal Investigators will be responsible for the direction of the
Study in accordance with applicable Institution policies, which Institution
warrants and represents are not inconsistent with the terms of this
Agreement, the Protocol, generally accepted standards of good clinical
practice, and all applicable local, state, and federal laws and regulations
governing the performance of clinical investigations. If, for any reason,
the above named individuals are unwilling or unstable to continue to serve
as Principal Investigators, Institution and Analytical Biosystems shall
appoint a mutually acceptable successor Principal Investigator. If a
mutually acceptable successor is not available, this Agreement shall be
terminated as provided in Section 15.
3. PERFORMANCE PERIOD AND ENROLLMENT FOR PATIENTS
It is anticipated that the Study will commence on or about October 16, 1995
and the Study will be completed in or about October 16, 1996, unless
otherwise terminated in accordance with Section 15. The effective period
may be extended by mutual agreement as provided in Section 16. It is
agreed that the Study will involve the enrollment of a maximum of
(Information Omitted And Filed Seperately Subject To A Request For
Confidential Treatment) evaluable patients meeting all Protocol
eligibility requirements (the "Evaluable Patients") unless Analytical
Biosystems shall request, in writing, that additional Evaluable Patients
(the "Additional Patients" and together with the Evaluable Patients, the
"Patient") be enrolled in the Study. The Institution agrees to provide to
Analytical Biosystems insurance information for each patient, along with
an assignment of benefits to Analytical Biosystems. Analytical Biosystems
will not xxxx patients for non-reimbursed tests performed by Analytical
Biosystems during the course of this study. In no event shall Analytical
Biosystems be obligated to pay any sums for tests performed on Patients
who do not meet all Protocol eligibility criteria or for Additional
Patients who are enrolled in the Study without Analytical Biosystems'
prior written approval.
4. COST AND PAYMENT
A. As consideration for performance under the terms of this Agreement,
Analytical Biosystems shall provide financial support for the Study
in a total amount, including overhead, not to exceed five hundred
sixty-eight thousand dollars ($568,000.00 - (Information Omitted
And Filed Seperately Subject To A Request For Confidential Treatment)
(the "Grant Amount"), payable as set forth in Schedule A attached
hereto and incorporated herein by reference.
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B. Checks will be made payable to: " "
Checks will be sent to:
Attention: (Information Omitted and Filed Seperately Pursuant To A
Confidentiality Request)
Institution Tax Identification Number: (Information Omitted and Filed
Seperately Pursuant To A
Confidentiality Request)
(Information Omitted and Filed Seperately Subject To A Request For
Confidential Treatment)
There will be no other costs to Analytical Biosystems Corporation.
5. ACCESS
Analytical Biosystems will have access to all information resulting from
the Study and shall have the unrestricted royalty-free right to utilize the
information. Data and information will be made available in hard copy and
machine readable disk to Analytical Biosystems. Data or information will
not be disclosed or made available to any other company which performs any
assay or test on solid mass tumors or for use in article or publication
which compares the fluorescent cytoprint assay (FCA) to any other test
without Analytical Biosystems' written consent.
6. CONFIDENTIAL INFORMATION
A. For a period of five (5) years after termination of this Agreement, the
Institution and the Principal Investigators shall not disclose or use
for any purpose other than performance of the study, any and all trade
secrets, know-how, privileged records or other confidential or
proprietary information and data, both technical and nontechnical
(collectively "Information"), disclosed to the Institution pursuant to
this agreement. The obligation of non-disclosure shall not apply to the
following:
(1) Information at or after such time that it is or becomes publicly
available through no fault of the Institution or the Principal
Investigators;
(2) Information that is already independently known to the Institution
or the Principal Investigators as evidenced by their prior written
records;
(3) Information at or after such time that it is disclosed to the
Institution or the Principal Investigators on a non-confidential
basis by a third party with the legal right to do so; or
(4) Information developed by the Institution or the Principal
Investigators without the use of Analytical Biosystems'
Information as evidenced by their written records.
B. In the event Analytical Biosystems shall come into contact with
Patient's medical records. Analytical Biosystems shall hold in
confidence the identity of the Patient and shall comply with all
applicable law(s) regarding the confidentiality of such records.
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7. PUBLICATIONS
The Institution shall have the right to publish the results of the Study.
Prior to submission for publication or presentation, the Institution and/or
the Principal Investigators will provide Analytical Biosystems thirty (30)
days to review any manuscript, and five (5) days to review any poster
presentation, abstract or other written or oral material Analytical
Biosystems, at its option, may be cited as a sponsor on any publication
resulting from the Study. In addition, if requested in writing and with
reasonable justification, the Institution and/or the Principal
Investigators will withhold such publication an additional sixty (60) days
to allow for filing a patent application or taking such other measures as
Analytical Biosystems deems appropriate to establish and preserve its
proprietary rights. Analytical Biosystems reserves the right to remove any
information that is confidential to Analytical Biosystems from any proposed
publication. Analytical Biosystems shall have the right to publish or
disseminate any information utilizing any portion of the data or
information obtained from the Study and may utilize or quote any portion of
any article or report prepared by the Institution or Principal
Investigators with respect to the Study. In all cases, any article or
report or summary of the Study shall not be published without Analytical
Biosystems' prior written consent.
8. REPORTS
The Principal Investigators agree to provide Analytical Biosystems with a
weekly investigator's report including patient accrual and patient tracking.
The Principal Investigators shall notify Analytical Biosystems promptly in
writing of any severe and life threatening or unexpected adverse reaction to
Analytical Biosystems products used during the Study. A final draft of the
manuscript resulting from the Study will serve as a final report; however,
in the event a manuscript is not forthcoming, a final report will be
submitted, including a summary of Study accrual, results of all data
analyses, and final conclusions.
9. USE OF THE INSTITUTION'S OR ANALYTICAL BIOSYSTEMS' NAME (ADVERTISING)
A. The Institution and Analytical Biosystems will obtain prior written
permission from each other before using the name, symbols and/or marks
of the other in any form of publicity in connection with the Study. This
shall not include legally required disclosure by the Institution or
Analytical Biosystems that identifies the existence of the Agreement.
B. Analytical Biosystems will not use, nor authorize others to use, the
name, symbols, or marks of the Institution in any advertising or
publicity material or make any form of representation or statement in
relation to the Study which would constitute an expressed or implied
endorsement by the Institution of any commercial product or service
without prior written approval from the Institution.
C. Neither Analytical Biosystems' name of the FCA will be identified in any
article, report, publication or summary comparing the FCA to any other
technology, except on Analytical Biosystems' written consent. Analytical
Biosystems shall have the right to distribute and disseminate and
utilize any study analysis or report or summary provided by Institution
and to identify the Institution and the Principal Investigators.
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10. NO TRANSFER OF PROPRIETARY RIGHTS NOT SPECIFIED
It is agreed that neither Analytical Biosystems, the Principal
Investigators nor the Institution transfers to the other by operation of
this Agreement any patent right, copyright right, or other proprietary
right of any party, except as specifically set forth herein.
11. CHANGES TO THE PROTOCOL
If at a future date changes in the Protocol appear desirable, such
changes may be made only upon prior notification and approval of
Analytical Biosystems. If such changes affect the cost of the Study,
the Institution will submit to Analytical Biosystems a written estimate
for approval. If in the course of performing the Agreement, however,
generally accepted standards of clinical study and medical practice
relating to the safety of Patients require a deviation from the
Protocol, such standards will be followed. In such case, the party
aware of the need for a deviation will immediately inform the other in
writing of the facts causing such deviations as soon as the facts are
known to the party.
12. MATERIAL
Analytical Biosystems agrees to provide transport materials and
instructions for shipment, technical assistance, and performance of in
vitro assays.
13. CONFORMANCE WITH LAW AND ACCEPTED PRACTICE
The Institution and the Principal Investigators shall perform the Study
in conformance with the Protocol, instruction provided by Analytical
Biosystems, good clinical practice guidelines, state and federal laws,
guidelines of the Institution, and patient consent requirements.
14. TERMINATION
A. This Agreement may be terminated:
(1) by the Institution upon thirty (30) days prior written
notice;
(2) by Analytical Biosystems upon written notice;
(3) by either the Institution or Analytical Biosystems if the
Principal Investigators are unwilling or unable to
continue to serve and a successor acceptable to both the
Institution and Analytical Biosystems is not available; or
(4) upon the occurrence of an event qualifying as a
termination event as described in the Protocol.
B. In the event this Agreement is terminated pursuant to Section
14.A., Analytical Biosystems shall be responsible for funding the
Study to the date of termination, such funds to be prorated on the
basis of the total financial support for the Study.
C. In the event the Institution shall terminate this Agreement prior
to accruing (Information Omitted And Filed Seperately Subject To
A Request For Confidential Treatment) patients, the Institution
shall return to Analytical Biosystems a rebate pro-rated at the
rate of $ (Information Omitted And Filed Seperately Subject To A
Request For Confidential Treatment) per patient.
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D. Upon the effective date of termination, there shall be an
accounting conducted by the Institution, subject to verification
by Analytical Biosystems. Within thirty (30) days after receipt
of adequate documentation Analytical Biosystems will make payment
to the Institution for all services properly rendered by the
Institution until the date of termination not yet paid for.
E. Immediately upon receipt of a notice of termination, the Principal
Investigators shall stop enrolling Patients into the Protocol
and shall cease conducting procedures on Patients already
enrolled in the Protocol as directed by Analytical Biosystems,
to the extent medically permissible and appropriate.
F. Termination of the Agreement by either party shall not affect the
rights and obligations of the parties accrued prior to the
effective date of the termination. The rights and duties under
Section 4,6,7,8,9,10,12,13,14 and 20 survive the termination or
expiration of this Agreement.
G. If this Agreement is terminated prior to completion, Institution
shall furnish Analytical Biosystems an acceptable Investigator's
report for the Study.
15. AMENDMENTS
This Agreement may only be extended, renewed or otherwise amended by the
mutual written consent of parties hereto. Any amendments to the
protocol must be approved by the Institutions' IRB and Analytical
Biosystems.
16. ENTIRE AGREEMENT
This Agreement represents the entire understanding of the parties with
respect to the subject matter hereof. In the event of any inconsistency
between this Agreement and the Protocol, the terms of this Agreement
shall govern.
17. SEVERABILITY
The invalidity or unenforceability of any term or provision of this
Agreement shall not affect the validity or enforceability of any other
term or provision hereof.
18. ASSIGNMENT
Neither the Institution nor the Principal Investigators may assign, code
or transfer any of their rights or obligations under this Agreement
without the prior written consent of Analytical Biosystems.
19. WAIVER
No waiver of any term, provision or condition of this Agreement whether
by conduct or otherwise in any one or more instances shall be deemed to
be or construed as a further or continuing waiver of any such term,
provision or condition, or of any other term, provision or condition of
this Agreement.
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20. NOTICE
Any notice required or permitted hereunder shall be in writing and shall
be deemed given as of the date it is (A) delivered by hand or (B)
received by Registered or Certified Mail, postage prepaid, return
receipt requested, or received by facsimile and addressed to the party
to receive such notice at the address set forth below, or such other
address as is subsequently specified in writing:
If to Analytical Biosystems: If to Institutions and /or
Principal Investigators:
Analytical Biosystems (Information Omitted And
55 Access Road Filed Seperately Subject
To A Request For
Confidential Treatment)
Xxxxxxx, XX 00000-0000
Copies to:
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate
by proper persons whereunto duly authorized.
ANALYTICAL BIOSYSTEMS: INSTITUTION:
By /s/ J. Xxxxxx Xxxxxxxxxx By (Information Omitted And
----------------------------- Filed Seperately Pursuant
(signature) To A Confidentiality Request)
------------------------------
(signature)
J. Xxxxxx Xxxxxxxxxx
-----------------------------
(Print or type name) Principal Investigator
PRESIDENT (Information Omitted And Filed
----------------------------- Seperately Pursuant To A
(Title) Confidentiality Request)
8/14/95 -------------------------------
----------------------------- (Date) 8/7/95
(Date)
(Information Omitted And Filed
Seperately Subject to A Request
For Confidential Treatment)
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95-80
A PROSPECTIVE RANDOMIZED TRIAL COMPARING
OMITTED IN ITS ENTIRETY
SCHEDULE A
The Grant Amount shall be payable as follows: (Information Omitted And Filed
Seperately Subject To A Request For Confidential Treatment)
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95-80
A PROSPECTIVE RANDOMIZED TRIAL COMPARING
EMPIRIC THERAPY VERSUS CHEMOTHERAPY DIRECTED BY
IN VITRO SENSITIVITY TESTING IN PATIENTS WITH
CARCINOMA OF UNKNOWN PRIMARY SITE
OMITTED IN ITS ENTIRETY AND FILED SEPERATELY
SUBJECT TO A REQUEST FOR CONFIDENTAIL TREATMENT
