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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


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