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TECHNICAL SERVICES AGREEMENT
For Research and Development
AGREEMENT NUMBER CP040801
LABOR AND MATERIALS Type
Battelle Memorial Institute, through its Commercial Business Operations
(BATTELLE) agrees to provide to Computerized Thermal imaging, Inc. (CLIENT)
technical/research services relating to technical consulting to aide in the
submittal of regulatory submissions to FDA for a thermal imaging system
for assistance in the diagnosis of breast cancer, substantially in accordance
with BATTELLE's Proposal No. CP040801, (the Project) incorporated herein by
reference, under the following terms and conditions:
1. ACCEPTANCE AND COMMENCEMENT
BATTELLE's Proposal may be accepted within sixty (60) days from the date of
BATTELLE's signature below. BATTELLE will begin work within thirty (30) days
of receipt of this Agreement executed by CLIENT. The Project period is
estimated as five (5) months from commencement.
2. PAYMENT
CLIENT agrees to pay BATTELLE's charges for labor services, estimated
[Redacted due to confidentiality: contains industry sensitive or intellectual
property provisions.]plus charges for other expenses incurred in the
performance of the Project, without set-off, payable within thirty (30) days
of the date of semimonthly invoices.
CLIENT will not be required to reimburse, and BATTELLE shall not be required
to incur any charges in excess of the estimate stated above, unless mutually
agreed upon in writing. Invoices not paid within thirty (30) days of the date
of invoice shall accrue interest at the rate of two (2) percent per month.
CLIENT will provide a deposit prior to commencement of work in the amount of
[Redacted due to confidentiality: contains industry sensitive or intellectual
property provisions.] The deposit amount will be returned to CLIENT upon
receipt of final payment, or applied to the final invoice, at CLIENT's option.
Travel, materials, and other non-labor charges will be billed in addition to
the above amount.
3. INTELLECTUAL PROPERTY
[Redacted due to confidentiality: contains industry sensitive or intellectual
property provisions.]
Technical Services Agreement No. CP040801
4. NO ENDORSEMENT/LITIGATION
BATTELLE does not endorse products or services. Therefore, CLIENT agrees that
it will not use or imply BATTELLE's name, or use BATTELLE's reports, for
advertising, promotional purposes, raising of capital, recommending
investments, or any way that implies endorsement by BATTELLE, except with
prior written approval of an officer of BATTELLE.
BATTELLE does not undertake Projects for the purposes of litigation or to
assign fault or blame and does not provide expert witness services. Therefore,
CLIENT agrees not to use any Project results in any dispute, litigation, or
other legal action.
In any event, if, at any time, BATTELLE or its employees are required to
respond to any subpoenas, orders for attendance at depositions, hearings or
trials, document requests, or other legal proceedings as a result of or
relating to BATTELLE's work on the Project, CLIENT agrees to reimburse
BATTELLE, in addition to any other amounts payable under this Agreement,
BATTELLE's labor charges, attorney time and/or fees, travel, photocopying and
other miscellaneous expenses.
5. CONFIDENTIALITY
If proprietary information other than Project results is disclosed by either
party to the other in connection with the performance of this Agreement, the
receiving party agrees that such information shall be maintained in confidence
for a period of five (5) years from the date of disclosure, provided that such
information is clearly identified in writing as proprietary. Oral disclosures
of proprietary information must be identified as proprietary at the time of
disclosure and must be followed by written confirmation within two (2) weeks.
The parties shall not be liable for disclosures made inadvertently or by
mistake, providing the parties exercise the same standard of care to protect
the information received as they do to protect their own proprietary
information. These obligations with respect to handling proprietary
information shall not be applicable to the following: (a) information that is
now in, or hereafter enters, the public domain through no fault of the
receiving party; (b) information that was previously known by the receiving
party independently of the disclosing party; (c) information that is
independently developed by the receiving party; (d) information that is
disclosed with the written approval of the other party; or (e) information
that is received from a third party without a duty of confidentiality.
No license to the other party, under any trademark, patent, or copyright is
either granted or implied by conveying information to that party. None of the
information that may be submitted or exchanged by the respective parties shall
constitute any representation, warranty, assurance, guarantee or inducement by
either party to the other with respect to infringement of trademarks, patents,
copyrights or any right of privacy, or other rights of third persons. The
confidentiality obligations of this paragraph shall survive the termination or
expiration of this Agreement.
6. LIMITATION OF LIABILITY
BATTELLE will provide a high standard of professional service on a best
efforts basis. However, BATTELLE, as a provider of such services, cannot
guarantee success; thus BATTELLE MAKES NO WARRANTY OR GUARANTEE, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF FITNESS FOR A PARTICULAR
PURPOSE OR MERCHANTABILITY, FOR ANY REPORT, DESIGN, ITEM, SERVICE, OR OTHER
RESULT TO BE DELIVERED UNDER THIS AGREEMENT.
Except for liability for injury to persons or damage to property occurring
during performance of the Project on BATTELLE-owned premises where fault of
CLIENT is not a contributing cause, CLIENT agrees: 1)
2
Technical Services Agreement No. CP040801
to assume all responsibility for CLIENT's use, misuse, or inability to use the
Project results; 2) to release BATTELLE from any liability to CLIENT for
damages, including but not limited to any indirect, incidental or
consequential damages, arising from or in connection with this Agreement and
any services provided under it; and 3) to indemnify and hold BATTELLE harmless
from any and all liabilities, suits, claims, demands and damages, and all
costs and expenses in connection therewith, in any manner relating to this
Agreement or its performance, asserted by third parties from any cause
whatsoever.
7. NATURE OF SERVICES
CLIENT agrees that BATTELLE is an independent contractor and specifically
acknowledges that BATTELLE is a service provider, not a manufacturer or
supplier. CLIENT retains all final decision making authority and all
responsibility for the formulation, design, manufacture, assembly, packaging
marketing and sale of CLIENT's products, including, without limitation,
product labeling, warnings, instructions to users, and for obtaining any
governmental or other pre- or postmarket approvals, certifications,
registrations, licenses, or permits.
8. PRODUCT LIABILITY INSURANCE
CLIENT shall maintain adequate product liability insurance coverage in amounts
customary and prudent for a responsible entity in its industry in light of the
nature of its product(s). Such insurance shall specifically cover any CLIENT
products that may be developed in whole or in part based on BATTELLE's work
under this Agreement, and CLIENT shall provide evidence of such insurance upon
request.
9. FORCE MAJEURE
Neither CLIENT nor BATTELLE shall be liable in any way for failure to perform
any provision of this Agreement (except payment of monetary obligations) if
such failure is caused by any law, rule, or regulation, or any cause beyond
the control of the party in default.
10. EARLY TERMINATION
Either party shall have the right to terminate this Agreement upon thirty (30)
days' written notice for any good-faith basis. In the event of early
termination, BATTELLE agrees to provide CLIENT with all reports, materials, or
other deliverable items available as of the date of the termination, provided
that CLIENT is not in default of its obligations under this Agreement. In any
event, CLIENT agrees to pay all charges incurred or committed by BATTELLE,
including costs of termination, within thirty (30) days of receipt of a final
invoice.
11. ENTIRE AGREEMENT
This Agreement, including the Proposal incorporated herein, represents the
entire Agreement of the parties and supersedes any prior discussions or
understandings, whether written or oral, relating to the subject matter
hereof. This Agreement may be modified or amended only by mutual agreement in
writing. No course of dealing, usage of trade, waiver, or non-enforcement
shall be construed to modify or otherwise alter the terms and conditions of
this Agreement. In the event of any conflict or inconsistency between these
terms and conditions and the Proposal, these terms and conditions shall
control.
3
Technical Services Agreement No. CP040801
12. APPLICABLE LAW
This Agreement shall be governed by and construed in accordance with the laws
of and enforced within the jurisdiction of the State of Ohio.
13. MISCELLANEOUS
This Agreement may not be assigned in whole or in part without the prior
written approval of both parties. In any event, however, this Agreement shall
be binding upon, inure to the benefit of, and be enforceable by and against
the successors, assigns and transferees of the parties. If any part of this
Agreement shall be held invalid or unenforceable, such invalidity and
unenforceability shall not affect any other part of this Agreement. Captions
used as headings in this Agreement are for convenience only and are not to be
construed as a substantive part of this Agreement.
Computerized Thermal imaging, Inc. BATTELLE MEMORIAL INSTITUTE
Commercial Business Operations
By /s/ X.X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxxx, Xx.
Name X.X. Xxxxxx Name Xxxxxx X. Xxxxxxx, Xx.
Title COO Title Contracting Officer
Date March 19, 1999 Date March 1, 1999
4
August 25, 1999
Proposal/Agreement No. CP042481
Xxxx Xxxxxxxxxxxxx
Computerized Thermal Imaging, Inc.
000 Xxxxxxxx Xxxx Xxxx, Xx. 000
Xxxxxx, XX 00000
Dear Xxxx:
Continued Consulting Support for the Development
of an Infrared Imaging System for Breast Pathologies
Per our discussion, CTI desires to expand and continue the consulting effort
undertaken by Battelle on CTI's behalf. Recent trips to CTI by Xxxxx Xxxx,
Patina Xxxxxx, and Xxxxxx Xxxxxx have been productive in helping CTI identify
key areas in the development of the thermal imager system. Areas where
Battelle assistance has been requested include the following:
* Support in Algorithm Development. Battelle has performed analysis of CTI's
classifier and feature extraction algorithms and has provided estimates of the
level of performance that can be expected from those algorithms. CTI has
requested additional work be done by Battelle to refine and improve the
performance of those algorithms.
* Organization of Design Files. Battelle had earlier suggested a plan for
assessing and organizing the Design History File for CTI. Afterthe audit of
the CTI files for the thermal imaging system, additional areas for
contribution by Battelle were identified. The predominant area of additional
assistance is in the creation of a Product Quality Plan for CTI, although the
scope of other subtasks can be increased as well.
* Statistical Consultation for FDA. CTI has requested continued involvement by
Battelle during interactions with the FDA, supporting discussions regarding
the impact of clinical approaches on the statistical validity of CTI data.
* Manufacturing Review. CTI has requested continued assistance in the
evaluation of contract manufacturers who could manufacture the CTI Patient
Positioning Device.
1999 Battelle - The information contained in this proposal is proprietary.
Please do not circulate to others not directly responsible for making a
decision regarding this proposal.
Xxxx Xxxxxxxxxxxxx
August 25, 1999
Page 2
Our Approach
Battelle provided a task list in an earlier fax transmission to CTI. The
following table includes this task list and details the work that Battelle
expects to perform for CTI. As we discussed, the direction of work required by
CTI is dynamic, so the specifics for these tasks may depart somewhat from the
list in this proposal. Should the tasks depart from this list sufficiently
that the deliverables need to change for this project, CTI will be notified.
We will proceed with the tasks noted in the table with the team already
established at Battelle. The statistical portion of the work will be led by
Xx. Xxxxx Xxxx, who will be supported by Xxxxxxx Xxxxxxx. Patina Xxxxxx will
lead the effort for the Design History File work. Xxxxxx Xxxxxx will continue
to support Patina. Xxxx Xxxxxxx will continue to oversee this project.
Deliverables
The deliverables for the overall project have been modified to reflect the
current direction of the project. They now consist of the following:
As listed in our Proposal No. CP040801 dated March 1, 1999:
* Report summarizing the evaluation of the design review of the hardware and
software approach as it relates to the FDA submittal. (Generally, this is a
high-level review, which does not include details such as FMEA, fault-tree,
etc.).
* Report summarizing Battelle's analysis of statistical approach to training
data and verification data (initial report already delivered. Subsequent
updates will be provided to match work done in the statistics area as noted
above).
* Project plan for subsequent activities.
New Deliverables:
* DHF Audit Report (already delivered).
*Summary report at the end of this project detailing the findings/
recommendations for the statistical approach, including classifier and feature
extraction algorithms.
*A product quality plan for the thermal imager system.
* Summary report of design control evaluation and recommendations.
Please note that the following deliverable, as listed in our Proposal No.
CP040801 dated March 1, 1999 has been deleted from this modified scope of
effort.
* Review status of clinical trials and determine the need for additional
training data versus additional verification data.
Xxxx Xxxxxxxxxxxxx
August 25, 1999
Page 3
Task Subtasks
------------ ---------------------------------------- ----------------------------------
Battelle 1 . Clinical Trial Design * Other methods for classifier estimation
Statistics * Develop data analysis protocol - Data transformation before using EM
Support to CTI * Establish data quality objectives method
* Determine minimum sample sizes to meet - Linear and quadratic discriminant
data quality objectives analysis
2. Review methods used by TRW - Ridge discriminant analysis
A. Methods for classifier training and selection - Partial least squares discriminant
analysis
* EM method for density estimation and B. Methods to advance feature extraction
classifier estimation 4. Recommend methods and minimum sample
* Leave-one-out method for ROC sizes for training classifier
generation * Use bootstrap method to relate the width of
B. Methods for feature extraction confidence intervals for AUC and SPEC to:
* Double-exponential curve fitting - Training sample sizes
* Region-of-interest characterization - Methods used to train classifier
3. Develop new methods - Methods used to extract features
A. Methods to advance classifier development * Make recommendations on best methods to
* Bootstrap confidence intervals for area- extract features, best methods to train
under-ROC-curve (AUC) and classifier, and associated minimum sample
specificity-at-fixed-sensitivity (SPEC) sizes
-------------------------------------------------------------------------------------------------------------------------
Statistical Approximately 1 week effort
Support at FDA
-------------------------------------------------------------------------------------------------------------------------
Design History Review contents of documentation * Continue gathering information.
File and CIA * Review/input to QSIT document * Update the plan as it evolves
System * Interviews to document folklore Lead the effort in compiling existing documentation
Review HW/WSW status that will provide some history and traceability to
* Develop requirements and risk assessment the existing design.
* Develop Requirements Traceability * Gather all documentation that is generated or
provided. Label, organize, etc., the historical
* Req Pro Training documentation.
* Format the database tables * Establish a structure for the "new"design history
* Enter all appropriate design information file.
* Make appropriate linkages Create a necessary quality system procedures to
Assist CTI in the development of the Development meet QSR
Plan for the Breast Scanner System * Interview staff from CTI and TRW to learn about
* Define high-level tasks as they relate to the the existing process (design control, document
QSR. control, device master record, corrective actions,
etc).
* Determine what documentation meets the * Identify gaps in the existing process.
needs of each requirement. * Define responsibilities within the organizations
* Assign responsibilities and interfaces between
all parties involved in the design. * Create procedures to address QSR
* Determine review levels and control levels for requirements (a Product Quality Plan)
design documents * Train staff, as appropriate
Follow up and expedite all actions generated from Perform a follow-up audit against the Design
the design control audit. Control Audit Results and also the PQP
* Generate a plan of action / audit notes.
-------------------------------------------------------------------------------------------------------------------------
Support for Approximately 1 week worth of consulting
manufacturing
qualification
Xxxx Xxxxxxxxxxxxx
August 25, 1999
Page 4
Estimated Cost and Schedule
[Redacted due to confidentiality: contains industry sensitive or intellectual
property provisions.]
Nature of Services
Battelle's performance of services for this project is that of a professional
service provider, and not a manufacturer or supplier. CTI will retain all
final decision-making authority and responsibility for the formulation,
design, manufacturing, marketing, and selling of its products. CTI will have
responsibility for providing product labels, warnings, and instructions for
the users of its products and will have responsibility for obtaining
regulatory approval for any product or device.
Xxxx Safterthwaite
August 25, 1999
Page 5
Key Assumptions
Key assumptions used to generate this proposal include the following:
* CTI will provide Battelle the data required to facilitate analysis of the
statistical approach to the classifiers and feature extraction algorithms in a
timely fashion.
* CTI will work with Battelle and facilitate TRW's participation in the
development of documentation to support the design history file.
To authorize this effort, please sign and return one original copy of the
enclosed extension agreement. This proposal is valid for 14 days. We are ready
to initiate work immediately upon authorization.
We look forward to assisting CTI in this effort. If you have any questions on
this proposal, please call Xxxx Xxxxxxx at (000) 000-0000. Questions of a
contractual nature may be directed to Xx. Xxx Xxxxxxx at (000) 000-0000.
Sincerely,
/s/ Xxxx Xxxxxxxx /s/ Xxxxxx X. Xxxxxxx Xx.
Xxxx Xxxxxxx Xxxxxx X. Xxxxxxx Xx.
Project Manager Contracting Officer
Product Development Group Commercial Business Operations
CP042481
MN003763
EXTENSION OF SPONSORED RESEARCH PROJECT
BATTELLE MEMORIAL INSTITUTE
Commercial Business Operations
AND
Computerized Thermal Imaging, Inc.
1. Battelle Memorial Institute, through its Commercial Business Operations,
hereinafter called Battelle, is conducting for Computerized Thermal Imaging,
Inc. hereinafter called Client, research investigations relating to providing
technical consultation regarding a thermal imaging system for assistance in
diagnosis of breast cancer, and assist Client in filing regulatory submissions
to the FDA.
2. Client desires to extend these research investigations for a period of
three (3) months, substantially in accordance with Battelle's
proposal/agreement identified as CP042481, which is made a part hereof by
reference, and desires that Research Agreement CP040801, between Client and
Battelle, be continued as outlined above.
3. Battelle agrees to extend this research as specified in Paragraph 2. above
and, in consideration of this extension, Client agrees to continue to pay the
research costs and to increase the current appropriation by [Redacted due to
confidentiality: contains industry sensitive or intellectual property
provisions.] for costs and fee incurred, payable semi-monthly, upon
presentation of invoices.
4. Except as herein modified, the conditions of the research agreement will
remain in effect.
5. This agreement shall become void if not executed by Client and returned to
Battelle by September 20, 1999.
Computerized Thermal Imaging, Inc. BATTELLE MEMORIAL INSTITUTE
Commercial Business Operations
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxxx Xx,
Name Xxxxx X. Xxxxxx Name Xxxxxx X. Xxxxxxx, Xx.
Title President Title Contracting Officer
Date Aug. 30, 1999 Date August 20, 1999
