EXHIBIT
10.6
Confidential
treatment has been requested for portions of this Exhibit. The copy
filed herewith omits the information subject to the confidentiality
request. Omissions are designated as (******). A complete version
of this Exhibit has been filed separately with the Securities and
Exchange Commission.
CLINICAL IMAGING
DEVELOPMENT AND SERVICES AGREEMENT
This Agreement
("Agreement") is by and between VirtualScopics, LLC, a New York
limited liability company with its principal place of business
located at 350 Linden Oaks, Rochester New York 14625
("VirtualScopics") and Pfizer Inc, 235 East
42nd Street, New York, New York 10017-5755, and its Affiliates
("Pfizer").
Whereas, Pfizer
Inc and VirtualScopics were engaged in a previous agreement for
Clinical Imaging and Services with an effective date of June 26
th , 2002; and
Whereas, Pfizer
Inc and VirtualScopics wish to continue to work together in the
further development and validation of image analysis software and
image-based biomarkers for use in the development of information
for submission to regulatory agencies in support of applications
for drug approvals and to encourage the wide acceptance of
image-based biomarkers by regulatory agencies and the medical
industry; and
Now therefore,
in consideration of the foregoing and the mutual covenants
contained herein, the parties hereby agree as follows:
1.
DEFINITIONS
"Affiliate" means any corporation or other business entity
that directly or indirectly controls, is controlled by, or is under
common control with Pfizer Inc.
"Collaborator" means third parties such as universities,
companies or individual consultants with whom Pfizer has
contractual relationships.
"CRO
Toolbox" means any
Toolbox identified in the POP as being developed by VirtualScopics
for use by VirtualScopics or a VirtualScopics partner in the
provision of clinical research services, including the provision of
Image Analysis Service to Pfizer.
"Development Plan" means the overall plan for the conduct of
Toolbox Development Services to be carried out by VirtualScopics
each year.
"Effective Date" means July 26, 2005.
"Enhancements" means any and all changes or additions to the
Software and Toolboxes, including without limitation any fixes,
error corrections, improvements and upgrades thereof.
"Image
Analysis Protocols" means the protocols describing the steps and
methodologies required to operate the Software and to perform
specific image processing and analysis procedures, including Image
Based Biomarkers.
"Image
Analysis Services" means the provision of clinical research
services using Toolboxes including, the set up of imaging sites and
the processing and analysis of images from preclinical or clinical
studies.
"Image
Based Biomarkers" means the methods of assessing a quantifiable
biological characteristic, whether patentable or not.
"Maintenance" means the maintenance to be provided by
VirtualScopics as described in Exhibit A.
"NonVS-based Pfizer Toolbox"
means any Pfizer Toolbox identified
in the POP as being based upon Pfizer's or its Collaborator's
Software.
"Pfizer
Toolbox" means any
Toolbox identified in the POP as being developed by VirtualScopics
for Pfizer's own research and development use, to be operated
routinely at Pfizer sites, or at Pfizer's Collaborators'
sites.
"Project Deliverables"
means the description, features,
functions and specifications for the deliverables, as set forth in
each POP.
"Project Operating Plan" or
"POP" means the
detailed plans - with staged deliverables, and anticipated expenses
- for each Toolbox Development Services project to be carried out
under the Development Plan.
"Release Event" means: (i) the filing by or against
VirtualScopics of insolvency, receivership or bankruptcy
proceedings, or any other proceedings for the settlement of
VirtualScopics debts, or (ii) VirtualScopics voluntary or
involuntary liquidation or dissolution, or (iii) VirtualScopics
ceases to do business or an inability to meet its obligations and
commitments under this Agreement, or (iv) VirtualScopics is
unwilling or unable (except under circumstances beyond
VirtualScopics' control and as long as such circumstances do not
continue for a period longer than sixty days), to provide Image
Analysis Services with respect to CRO Toolboxes or VS-Based
Toolboxes at the rates listed in Exhibit B, and within reasonable
planning and execution timeframes as outlined in a POP.
"Site
Operating Guides" means the guidelines and protocols aimed at
calibrating and operating various instrument modalities to generate
images of appropriate quality to allow further image processing and
analysis.
"Software" means novel algorithms and software code both in
human and machine readable form and documentation needed to
install, train and operate such code.
"Toolbox" means a module consisting of Software, Image
Analysis Protocols and Site Operating Guides for the analysis of
one or more Image Based Biomarkers.
"Toolbox Platform" means the VirtualScopics operating system
software, middleware, and other platform systems necessary to
produce and operate Toolboxes, as further described in Exhibit
A.
"Toolbox Development Services"
means activities including the
design, development, testing, installation, end-user training of
Toolboxes.
"VS-Based Pfizer Toolbox"
means any Pfizer Toolbox identified
in the POP as being based upon VirtualScopics' Toolbox Platform or
Software.
2.
DEVELOPMENT PLAN & PROJECT OPERATING
PLANS
2.1
Development Plan. Pfizer and VirtualScopics
will collaborate in the design and implementation of the
Development Plan. The Development Plan will include objectives,
projects and timelines for the following 12 months. The initial
Development Plan will be prepared by the Joint Steering Committee
("JSC") within 60 days of the Effective Date. The JSC will update
the Development Plan on a semi-annual basis to reflect, amongst
other matters, changes in Pfizer's research and development
priorities.
2.2
Diligent Efforts. VirtualScopics will use
diligent efforts to complete each approved POP implemented under
the Development Plan. VirtualScopics will assign appropriately
project managers with appropriate skills, experience and
qualifications to each POP. Pfizer will assign a point person for
each project for regular communication with Virtualscopics project
managers.
2.3
Scientific Direction. Through the JSC,
Pfizer will provide strategic scientific direction to
VirtualScopics at least twice a year, and will facilitate exposure
of VirtualScopics' capabilities to Pfizer's research and
development teams in order to generate a pipeline of specific
projects in line with the Development Plan.
2.4
POPs. Pfizer provides no commitment under
this Agreement to fund a minimum number of POPs during the term of
this Agreement. All POPs are subject to Pfizer's prior written
approval. VirtualScopics must not commence work under a POP until
it receives written approval from Pfizer's chair of the JSC, or his
Pfizer designee.
2.5
Termination of POPs. Pfizer may terminate
any POP at anytime, for any reason by giving VirtualScopics written
notice. Upon receipt of the notice, VirtualScopics will stop all
ongoing activities under the POP, and will account to Pfizer for
all fees incurred up to that point at the rates listed in Exhibit
B, as well as any expenses incurred as a result of stopping the
activities, provided such expenses were pre-approved by Pfizer in
writing. Pfizer's only obligation with respect to such POP will be
to pay for these fees and such pre-approved expenses.
2.6
Reporting. VirtualScopics will maintain a
running list of all approved and proposed POPs, incurred and
anticipated expenses and will provide quarterly updates to the JSC,
or more frequently as needed and as reasonably requested by Pfizer.
VirtualScopics will report progress under each POP at a frequency
and through the means described in the specific project POPs.
VirtualScopics will report to the JSC on the overall progress
against the Development Plan in writing on a quarterly
basis.
3.
IMAGE ANALYSIS SERVICES.
3.1
From time to time, Pfizer may engage VirtualScopics to
provide Image Analysis Services. The Image Analysis Services will
not be performed under the terms of this Agreement, but separate
agreements to be entered into by the parties. But, the fees for
such services will be determined in accordance with the fee
schedule in Exhibit B.
3.2
In return for Pfizer's support and funding of the development
of Toolboxes, VirtualScopics agrees that for Image Analysis
Services using CRO Toolboxes it will provide Pfizer with certain
discounts as outlined in the fee schedule in Exhibit B.
4.
SUPPLY OF EXPERT PERSONNEL
4.1
FTEs. VirtualScopics will supply to Pfizer
the services of (*****) ("FTE") to perform the following ("FTE
Services") at Pfizer sites designated by Pfizer from time to time,
and at the rates listed in Exhibit B:
(a)
install the Software for Pfizer Toolboxes at various Pfizer
sites and train Pfizer employees in the use of the Software and the
Pfizer Toolbox;
(b)
develop Enhancements to the Pfizer Toolboxes at Pfizer's
direction; and
(c)
support, at Pfizer's direction, Pfizer projects -including
projects involving third parties - outside of the Development Plan
related to image analysis and development of image analysis
software.
(d)
support, at Pfizer's direction, the transfer of the Pfizer
Toolboxes and Toolbox Platforms to Pfizer or to third parties
immediately upon the provision of documentary evidence of one of a
Release Event. Such provision shall survive termination for reasons
outlined in section 13.4.
***** Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
4.2
Skills. VirtualScopics will ensure that the
FTEs will have the proper skill level and type of experience to
complete the FTE Services above in a good and workmanlike
manner.
4.3
Equipment. Except as otherwise agreed by
the parties in writing, VirtualScopics shall furnish or cause to be
furnished at its sole expense all required labor (including any
subcontractors), tools, equipment, material, parts, transportation
and supervision necessary to perform the FTE Services.
4.4
Removal. If at any time during the
performance of the FTE Services under this Agreement, Pfizer should
be dissatisfied with the performance of any personnel assigned for
reasons of unprofessional, illegal conduct, or inability to
adequately perform to Pfizer's standards or expectations, Pfizer
may demand the immediate removal and/or replacement of that person.
If Pfizer requests replacement, VirtualScopics shall use its best
efforts to provide another qualified person acceptable to Pfizer
within seven (7) business days.
4.5
Reassignment. VirtualScopics will not
change or reassign personnel initially assigned to perform the FTE
Services without thirty (30) days' prior written notice to Pfizer.
If a change or reassignment of personnel is required through
circumstances beyond VirtualScopics' control, Pfizer will have the
right, in Pfizer's sole discretion, either to approve new personnel
to be assigned or to cancel any portion of the FTE Services to be
performed. VirtualScopics shall ensure continuity of assignments in
the event of any or all personnel changes.
4.6
Background Checks. Pfizer may require that
any FTE first pass a suitable pre-employment and
background/reference check as specified and approved by Pfizer. The
current required background check will be supplied on request.
VirtualScopics shall cause all its employees to comply with
Pfizer's Drug Free Policy, a copy of which will be supplied on
request.
4.7
Duties. VirtualScopics shall perform the
FTE Services (a) in a good, workmanlike and efficient manner; (b)
in accordance with applicable laws, regulations, codes, permits and
licenses; (c) in accordance with all applicable policies, practices
and procedu