CLINICAL IMAGING DEVELOPMENT AND SERVICES AGREEMENT
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 000
Xxxxxx Xxxx, Xxxxxxxxx Xxx Xxxx 00000 ("VirtualScopics") and Pfizer
Inc, 000
Xxxx
00xx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000-0000, 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 26th,
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
procedures in place at the Pfizer site where FTE Services are being performed,
including, but not limited to, procedures regarding security, safety and
confidentiality; and (d) otherwise in accordance with the terms and conditions
applicable to all contractors, suppliers and vendors of Pfizer.
4.8 Relationship.
VirtualScopics
shall render the FTE Services as an independent contractor
and
acknowledges that VirtualScopics, its personnel, or employees are not employees
of Pfizer. Accordingly, neither VirtualScopics nor its employees or personnel
will (a) participate in Pfizer employee benefit plans nor receive any other
compensation beyond that stated in Section 9.2, (b) have the power or authority
to bind Pfizer or to assume or create any obligation or responsibility, express
or implied, on Pfizer's part or in Pfizer's name, except as otherwise set forth
in this Agreement, or (c) represent to any person or entity that VirtualScopics,
its personnel or any employee of VirtualScopics has such power or authority.
VirtualScopics shall remain solely liable for all aspects of the employment
of
such persons including, without limitation, recruitment, hiring, firing,
training, promotion, compensation, all payroll taxes and other deductions and
all premiums or payments made for workers' compensation coverage, unemployment
benefits or any other payments required by law to be made by employers for
or on
behalf of employees.
4.9 Injury
& Damage.
Any
personal injury or property damage suffered by VirtualScopics
or by
VirtualScopics FTE in the course of carrying out the FTE Services will be
VirtualScopics' sole responsibility, except to the extent such personal injury
or property damage occurs on Pfizer's premises and is caused by Pfizer's
negligence.
4.10 Authorization.
VirtualScopics
represents and warrants that it and its personnel, and employees are authorized
to perform the FTE Services and that neither it nor its personnel or employees
will act in violation of any applicable immigration laws or regulations.
VirtualScopics shall indemnify Pfizer against any and all claims, fines,
penalties and/or attorneys' fees incurred by Pfizer for breach by the
VirtualScopics of any immigrations laws or regulations and of this
warranty.
4.11 Intellectual
Property. Except
for intellectual property created by an FTE in performance of specific duties
of
VirtualScopics under a POP, any intellectual property created or contributed
to
by an FTE in performance of the FTE Services will belong to Pfizer, and
VirtualScopics will promptly disclose any such intellectual property to Pfizer
and irrevocably assigns over to Pfizer all right, title and interest in and
to
such intellectual property. VirtualScopics will execute such documents and
take
such other action at Pfizer's expense as may be necessary or appropriate to
establish, register, record or otherwise document Pfizer's ownership therein
in
any country.
4.12 Information.
Except
for information produced by an FTE in performance of specific duties of
VirtualScopics under a POP, any information which an FTE obtains from Pfizer
or
produces in performance of the FTE Services will be Pfizer's Information for
the
purposes of Section 7. VirtualScopics is not given any right to use or disclose
such information under this Agreement.
5. JOINT
STEERING COMMITTEE
5.1 Members.
Pfizer
and VirtualScopics will establish a Joint Steering Committee ("JSC") composed
of
at least three employees from each party. Pfizer and VirtualScopics may appoint
its representatives at their sole discretion, and substitutes may be appointed
at any time. The parties will each appoint one of its representatives to act
as
the co-chair of the JSC. The members initially will be:
Pfizer
appointees:
(*****)
VirtualScopics
appointees:
(*****)
5.2 Duties.
The
JSC
will be charged with:
(a) coordinating
the parties activities hereunder;
(b) approving
allocations and prioritizations of tasks between the parties in order to carry
out the Development Plan;
(c) reviewing
the status of, discussing and approving modifications to the Development
Plan;
(d) encouraging
and facilitating ongoing cooperation between the parties; and
(e) performing
such other functions as appropriate to further the purpose of this
Agreement.
5.3 Meetings.
The
JSC
will meet formally via phone, videoconference or in person twice a year,
or
more frequently as determined by the JSC, at a time and location agreed to
by
the
parties.
JSC meetings will be chaired by a Pfizer JSC member. Each party will bear its
own expenses in connection with the meetings.
5.4 Minutes.
The
JSC
will keep accurate minutes of its deliberations and record all
proposed
decisions and actions recommended or taken. Drafts of the minutes will be
delivered to all JSC members within five business days after each meeting.
Each
party will alternatively
be responsible for the preparation and circulation of the draft minutes.
Draft
minutes
shall be edited by the co-chairpersons and will be issued in final form only
with their approval and agreement.
6. PROPRIETARY
RIGHTS AND LICENSE GRANTS
6.1 VS-Based
Pfizer Toolboxes
(a) Ownership.
VirtualScopics
will own the VS-Based Pfizer Toolboxes and all intellectual
property and materials in the VS-Based Pfizer Toolboxes created by
VirtualScopics, its employees, consultants or contractors in performance of
the
relevant POPs.
(b) License.
VirtualScopics
grants to Pfizer a perpetual, fully paid-up, non-exclusive, worldwide license
to
use, reproduce and modify the VS-Based Pfizer Toolboxes for
the
purposes of Pfizer's research and development of pharmaceutical
products.
Pfizer
may grant sublicenses to third parties for limited purpose of the third party
performing research or development activities on behalf of Pfizer.
______________________
***** 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.
6.2 NonVS-Based
Pfizer Toolboxes. Pfizer
will own the NonVS-Based Pfizer Toolboxes and
all
intellectual property and materials in the NonVS-Based Pfizer Toolboxes
created
by
VirtualScopics, its employees, consultants or contractors in performance of
POPs. VirtualScopics will, if deemed necessary or desirable by Pfizer, at
Pfizer's cost, execute an assignment of rights to Pfizer with respect to such
intellectual property.
6.3 Toolbox
Platform and CRO Toolboxes
(a) Ownership.
VirtualScopics
will retain ownership of the Toolbox Platform and CRO Toolboxes and all
intellectual property in the Toolbox Platform and CRO Toolboxes
created by VirtualScopics, its employees, consultants or contractors
in
performance of the Development Plan.
(b) License.
Upon
occurrence of a Release Event, VirtualScopics grants to Pfizer a perpetual,
fully paid-up, non-exclusive, worldwide license to use, reproduce and modify
the
Toolbox Platform and CRO Toolboxes, including those developed under the Clinical
Imaging and Services Agreement dated June 26th
2002,
and listed in Exhibit A, for the purposes of Pfizer's research, development
and
commercialization of pharmaceutical products. Pfizer may grant sublicenses
to
third parties for limited purpose of the third party performing research or
development activities on behalf of Pfizer.
6.4 Images
and Data provided by Pfizer from Pfizer trials. Pfizer
will retain ownership of all data and images provide by, or on behalf of, Pfizer
to VirtualScopics under the Development Plan. VirtualScopics may only use such
data and images for the purposes of performing the Development
Plan.
6.5 Enhancements.
Pursuant
to the terms of this Agreement, VirtualScopics shall provide to Pfizer all
Enhancements to the Pfizer Toolboxes and CRO Toolboxes at the same time that
VirtualScopics makes such Enhancements available to its other customers, and
at
a certain discounts, as listed in Exhibit B of its then commercial
prices.
6.6 Except
as
expressly provided in this Section 6 neither party is granted any right, title
or
interest
in any intellectual property owned or controlled by the other
party.
7. CONFIDENTIALITY
7.1 For
purposes of this Agreement, the term "Information" will mean:
(a) with
respect to Pfizer, the clinical and other data, images provided by, or on behalf
of, Pfizer to VirtualScopics under the Development Plan, the Development Plan,
the NonVS-Based Pfizer Toolboxes, all written information which Pfizer delivers
to VirtualScopics pursuant to this Agreement stamped or otherwise identified
in
writing on the document "Confidential" and all oral information which Pfizer
declares to be confidential and confirms such declaration in writing within
30
days of disclosure; and
(b) with
respect to the VirtualScopics, the Toolbox Platform, VS-Based Toolboxes and
CRO
Toolboxes, all written information which VirtualScopics delivers to Pfizer
pursuant to this Agreement stamped or otherwise identified in writing on the
document "Confidential" and all oral information which VirtualScopics declares
to be confidential and confirms such declaration in writing within 30 days
of
disclosure.
7.2 A
party
receiving Information ("Receiving Party) from the other party ("Disclosing
Party")
will maintain the Information in confidence with the same degree of care it
holds
its own
confidential information. The Receiving Party will only use and disclose the
Information for the purposes of performing its obligations or exercising its
rights under this Agreement and, except as permitted under this Agreement,
will
not disclose the Information to any third party and will only disclose the
Information to its officers and employees that need it for the purposes of
performing its obligations or exercising its rights under this
Agreement.
7.3 The
Receiving Party's obligation of nondisclosure and the limitations upon the
right
to use the Information will not apply to the extent that the Receiving Party
can
demonstrate that the Information:
(a) was
in
the possession of the Receiving Party prior to the time of disclosure;
or
(b) is
or
becomes public knowledge through no fault or omission of Receiving Party;
or
(c) is
obtained by Receiving Party from a third party under no obligation of
confidentiality to the Disclosing Party. All Information will be returned to
the
Receiving Party upon termination of this Agreement for any reason, except for
one
copy,
which Disclosing Party may use for the sole purpose of determining
its
continuing confidentiality obligation to the Disclosing Party under this
Agreement; or
(d) if
the
Receiving Party is requested or ordered to disclose the Information in
connection with a legal or administrative proceeding, the Receiving Party will
give the Disclosing Party prompt notice of such request. The Disclosing Party
may seek an appropriate protective order or other remedy or waive compliance
with the provisions of this Agreement or both. If the Disclosing Party seeks
a
protective order or other remedy, the Receiving Party will cooperate with the
Disclosing Party. If the Disclosing Party fails to obtain a protective order
or
waive
compliance within the relevant provisions of this Agreement, the
Receiving
Party
will disclose only that portion of Information which its legal counsel
determines it is required to disclose.
7.4 All
confidentiality obligations of under this Agreement shall survive the
termination of
this
Agreement for a period of five (5) years.
8. ACCEPTANCE.
Pfizer
may reject any deliverables under a POP if they do not meet the acceptance
criteria set forth in the POP or the Development Plan. Pfizer has 30 days from
receipt of the deliverables to reject them. If Pfizer rejects the deliverables
and VirtualScopics is unable to remedy the problem within 30 days of being
notified, Pfizer will not be required to pay to VirtualScopics any fees for
that
POP and may require the refund
of
any fees already paid for activities towards deliverables which have not met
the
acceptance criteria.
9. PAYMENTS.
9.1 Project
Operating Plans. The
rates
for VirtualScopics' performance of POPs are as listed in Exhibit B. Pfizer
will
pay VirtualScopics for the performance of approved POPs in accordance with
the
budget and timetable set out in the POP.
9.2 FTEs.
As
full and complete compensation for satisfactory performance of the
FTE
Services, Pfizer shall pay VirtualScopics as specified in Exhibit
B.
9.3 All
payments to be made under this Agreement will be due by Pfizer thirty (30)
days
after Pfizer's receipt and acceptance of a supporting invoice from
VirtualScopics. Each invoice shall reference the relevant Pfizer purchase order
number and be sent to Pfizer Inc, North American Shared Work Plan, X.X. Xxx
000000, Xxxxxxxx, XX 00000-0000 (*****).
10. REPRESENTATIONS
AND WARRANTIES. VirtualScopics
and Pfizer each represents and warrants as follows:
10.1 It
is a
corporation duly organized, validly existing and is in good standing under
the
laws of the State of Delaware in the case of Pfizer and the laws of New York
in
the case of VirtualScopics, is qualified to do business and is in good standing
as a corporation in each jurisdiction in which the conduct of its business
of
the ownership of its properties requires such qualification and has all
requisite power and authority, corporate or otherwise, to conduct its business
as now being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement.
10.2 The
execution, delivery and performance by it of this agreement have been duly
authorized by all necessary corporate action and do not and will not (a) require
any consent or approval of its stockholders, (b) violate any provision of any
law, rule, regulations, order, writ, judgment, injunctions, decree,
determination award presently in effect having applicability to it or any
provision of its certificate of incorporation or by-laws or (c) result in a
breach of or constitute a default under any material agreement, mortgage, lease,
license, permit or other instrument or obligation to which it is a party or
by
which it or its properties may be bound or affected.
10.3 This
Agreement is a legal, valid and binding obligation enforceable in accordance
with its terms and conditions, except as such enforceability may be limited
by
applicable bankruptcy, insolvency, moratorium, reorganization or similar laws,
from time to time in effect, affecting creditor's rights generally.
_________________
*****
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.
10.4 It
is not
under any obligation to any person, or entity, contractual or otherwise, that
is
conflicting or inconsistent in any respect with the terms of this Agreement
or
that would impede the diligent and complete fulfillment of its
obligations.
10.5 It
has
good and marketable title to or valid leases for, all of its properties, rights
and assets
necessary for the fulfillment of its obligations under this Agreement, subject
to no
claim of
any third party other than the relevant lessors or licensors.
11. INDEMNIFICATION
BY VIRTUALSCOPICS
11.1 VirtualScopics
will defend, indemnify and hold harmless Pfizer and its Affiliates, and its
or
their officers, directors, shareholders, employees, agents and representatives
from and against any and all liability, damage, loss, cost or expense (including
reasonable attorney's fees, costs and amounts paid in settlement) (collectively,
"Losses") resulting from
any
third party claim made or suit brought against Pfizer or any such persons
arising
out of
VirtualScopics breach of any of its representations or warranties in this
Agreement.
11.2 Upon
receipt of notice of any such claim or suit, Pfizer will promptly notify
VirtualScopics thereof and will permit VirtualScopics, at its cost, to handle
and control such
claim or suit. VirtualScopics will have the right to participate in the defense
of such
claim or
suit at its own expense. Pfizer will afford VirtualScopics all reasonable
assistance (at VirtualScopics' cost and expense) and will make no admission
prejudicial to the defense of such claim or suit.
11.3 The
foregoing indemnification obligation will not apply to any claim or suit to
the
extent it arises directly out of Pfizer's negligence, willful misconduct or
breach of any term, representation, warranty or covenant contained in this
Agreement.
12. INDEMNIFICATION
BY PFIZER
12.1 Pfizer
will defend, indemnify and hold harmless VirtualScopics and its Affiliates,
and
its or
their
officers, directors, shareholders, employees, agents and representatives from
and
against
any and all liability, damage, loss, cost or expense (including reasonable
attorney's fees, costs and amounts paid in settlement) (collectively, "Losses")
resulting from any third party claim made or suit brought against VirtualScopics
or any such persons arising out of Pfizer's breach of any of its
representations, or warranties in this Agreement.
12.2 Upon
receipt of notice of any such claim or suit, VirtualScopics will promptly notify
Pfizer
thereof and will permit Pfizer, at its cost, to handle and control such claim
or
suit.
Pfizer
will have the right to participate in the defense of such claim or suit at
its
own expense. VirtualScopics will afford Pfizer all reasonable assistance (at
Pfizer's cost and expense) and will make no admission prejudicial to the defense
of such claim or suit.
12.3 The
foregoing indemnification obligation will not apply to any claim or suit to
the
extent it
arises
directly out of Contractor's negligence, willful misconduct or breach of any
term,
representation, warranty or covenant contained in this Agreement.
13. TERMINATION
OF AGREEMENT
13.1 This
Agreement will end two years from the Effective Date. Unless this Agreement
has
been
terminated pursuant to the provisions of this section 13, Pfizer may elect
to
extend
the Term
of this Agreement for up to two additional years upon written notice to
Virtualscopics at least thirty (30) days before the second, and if applicable,
third anniversaries of the Effective Date.
13.2 Pfizer
may terminate this Agreement without cause by giving 30 days notice to
VirtualScopics in writing. If Pfizer terminates this Agreement without cause,
Pfizer's only obligation will be to pay VirtualScopics for the services
performed under the Agreement up to the date of termination, at the rates
provided in Exhibit B. All payments paid to the Contractor in excess of those
due to it under this Section will be returned to Pfizer.
13.3 If
either
party breaches this Agreement, the other may terminate it if the breaching
party
does not cure the breach within thirty (30) days of written notice of same.
Termination shall be without prejudice to any rights which may have been accrued
to either party before termination.
13.4 On
termination of this Agreement for any reason VirtualScopics will return, at
Pfizer's expense, all of Pfizer's data, images and other materials. In addition
the parties will return to each all copies of the other party's Information
except for one copy which may be retained for the sole purpose of determining
continuing obligations under Section 7.
13.5 (*****)
13.6 Termination
of this Agreement for any reason shall be without prejudice tothe rights and
obligations of the parties set forth in any Sections which provide by their
terms performance by either party subsequent to termination or any other
remedies which either party may otherwise have.
14. SOURCE
CODE ESCROW
14.1 Within
sixty (60) days of the execution of this Agreement, the parties will execute
an
escrow agreement (the "Escrow Agreement"). The escrow fees will be paid by
Pfizer.
___________________
***** 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.
***** 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.
14.2 Within
fifteen (15) days after execution of the Escrow Agreement, VirtualScopics shall
deposit with a mutually agreed firm which provides software escrow services
(the
"Escrow Agent"). During the term and on a quarterly basis, VirtualScopics will
deposit with the Escrow Agent any modifications or any new versions of these
Toolboxes protocols and guides since the previous quarters deposit, if any.
Within fifteen (15) days after
the
completion of any Toolbox, VirtualScopics shall deposit with the Escrow
Agent,
pursuant
to the terms of the Escrow Agreement, the software source code for the Toolbox
Platform, the CRO Toolboxes and the VS-Based Toolboxes in machine and human
readable form as well as the related Image Analysis Protocols and Sites
Operating Guides for the Toolboxes.
14.3 The
Escrow Agreement shall provide, among other things, for one complete copy of
the
materials and information in escrow to be released to Pfizer immediately upon
the provision to the Escrow Agent of documentary evidence of one of a Release
Event.
14.4 On
occurrence of a Release Event, VirtualScopics will provide Pfizer, at Pfizer's
costs, reasonable support to facilitate the transfer and use of the Toolbox
Platform, CRO Toolboxes, VS-Based Toolboxes, Image Analysis Protocols, Site
Operating guides, and any other relevant documents and information, to Pfizer
or
to a third party designated by Pfizer.
15. MISCELLANEOUS
15.1 During
the Term, Virtualscopics shall notify Pfizer, under confidentiality, at least
60
days prior to any sale, merger, acquisition, or transfer of all or substantially
all of the assets of Virtualscopics or to a third party ("transaction"), which
notice shall include the identity of such third party.
15.2 Governing
Law. This
Agreement shall be governed by and construed and enforced in accordance with
the
laws of the State of New York.
15.3 Severability.
If
any
provision or any portion of any provision of this Agreement is construed to
be
illegal, invalid or unenforceable, such provision or portion thereof shall
be
deemed
stricken and deleted from this Agreement to the same extent and effect as if
it
were
never incorporated herein, but all other provisions of this Agreement and the
remaining portion of any provision that is construed to be illegal, invalid
or
unenforceable in part shall continue in full force and effect.
15.4 Entire
Agreement. This
Agreement constitutes the entire agreement between the parties and supersedes
all previous agreements, promises, representations, understandings and
negotiations, whether written or oral, between the parties with respect to
the
subject matter hereof. Without limiting the foregoing in any way, this Agreement
specifically supersedes any "standard" or "shrink wrap" agreement or license
that may accompany the Licensed Products. Any modification and/or amendment
to
this Agreement must be in writing and executed by both parties.
15.5 Survival.
The
provisions of Sections 3, 4, 5, 6, and14 shall survive termination or expiration
of this Agreement.
15.6 Successors
and Assigns. All
the
terms and conditions of this Agreement are binding upon
and
inure to the benefit of the parties hereto, their successors, legal
representatives
and
permitted assigns. Either party may assign this Agreement upon the prior written
consent of the other party, such consent not to be unreasonably withheld. In
addition, Pfizer may transfer, lease, assign or sublicense its entire right,
interest and obligation hereunder to any Affiliate.
15.7 No
Agency Relationship Between the Parties. Neither
party shall represent itself as the agent or legal representative of the other
or as joint ventures for any purpose whatsoever, and neither shall have any
right to create or assume any obligations of any kind, express or implied,
for
or on behalf of the other in any way whatsoever.
15.8 Non-Waiver.
A
failure
of either party to enforce at any time any term, provision or condition of
this
Agreement, or to exercise any right or option herein, shall in no way operate
as
a waiver thereof, nor shall any single or partial exercise preclude any other
right or option herein; in no way whatsoever shall a waiver of any term,
provision or condition of this Agreement be valid unless in writing, signed
by
the waiving party, and only to the extent set forth in such
writing.
15.9 Facilities
Management and Data Loss Recovery. Nothing
express or implied in this Agreement shall prevent Pfizer from allowing duly
authorized agents of Pfizer to access and utilize any of the Toolboxes listed
in
Exhibit A to manage Pfizer's computer, LAN or other information technology
facilities.
15.10 Notices.
Unless
expressly stated otherwise, all notices required herein shall be given in
writing and shall be delivered (and notice shall be deemed effective upon
delivery) in person, by courier, or sent by certified United States mail,
postage prepaid, return receipt requested, to the following
address:
VirtualScopics
|
Pfizer,
Inc.
|
|
000
Xxxxxx Xxxx
|
00
Xxxxxx Xxx.
|
|
Xxxxxxxxx,
Xxx Xxxx 00000
|
Xxx
Xxxxxx, XX 00000
|
|
Attn:
Xxxxx Xxxxxxxxx
|
Attn:
General Counsel, PGRD
|
15.11 Counterparts.
This
Agreement may be executed in any number of counterparts, each of which shall
be
deemed to be an original, and all of which together shall be deemed to be one
and the same instrument.
15.12 Publicity.
Except
as
required by law, neither party may disclose the terms of neither this Agreement
nor the work described in it. VirtualScopics agrees that it shall not issue
any
press release or make any other public announcement with respect to this
Agreement without obtaining Pfizer's written authorization.
IN
WITNESS THEREOF, VirtualScopics and Pfizer have caused this Agreement to be
signed and delivered, all as of the date first hereinabove written.
VirtualScopics
LLC
|
Pfizer,
Inc.
|
|||
By: | /s/ Xxxxx Xxxxxxxxx | By: | /s/ Xxxx X. XxXxxxxxx | |
Name: |
Xxxxx Xxxxxxxxx |
Name: |
Xxxx X. XxXxxxxxx |
|
Title: | CFO | Title: | President PGRD | |
Date: | 8/9/05 | Date: | 8/8/05 |
Exhibit
A
I. Toolboxes
and Toolbox Descriptions
Legend:
Color
|
Description
|
Windows
Application
|
|
Web
Application
|
|
Automated
Task (command-line application)
|
|
Database
(SQL Server 2000)
|
OA
CRO Toolkit Components
Component
|
Description
|
Configuration
Editor
|
(*****)
|
Image
Sort and Inspection System (ISIS)
|
(*****)
|
Workflow
Editor
|
(*****)
|
Automated
Task Execution
|
(*****)
|
Medical
Editor
|
(*****)
|
Exception
Handler
|
(*****)
|
Dataset
Manager
|
(*****)
|
Biomarker
Reporter
|
(*****)
|
Workbook
Manager
|
(*****)
|
User
Management
|
(*****)
|
Audit
Trail Viewer
|
(*****)
|
Register
and Fuse
|
(*****)
|
Bone
Segmentation
|
(*****)
|
Segmentation
Tracking
|
(*****)
|
Biomarker
Extraction
|
(*****)
|
Cartilage
Extraction
|
(*****)
|
Fluid
and Edema Extraction
|
(*****)
|
Segmentation
Mapping
|
(*****)
|
Workflow
Database
|
(*****)
|
User
Database
|
(*****)
|
______________________
***** 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.
Oncology
CRO Toolkit Components
Component
|
Description
|
Configuration
Editor
|
(*****)
|
Image
Sort and Inspection System (ISIS)
|
(*****)
|
Workflow
Editor
|
(*****)
|
Automated
Task Execution
|
(*****)
|
Manual
Task Execution
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
Exception
Handler
|
(*****)
|
Dataset
Manager
|
(*****)
|
Biomarker
Reporter
|
(*****)
|
Workbook
Manager
|
(*****)
|
User
Management
|
(*****)
|
Audit
Trail Viewer
|
(*****)
|
(*****)
|
(*****)
|
Workflow
Database
|
(*****)
|
User
Database
|
(*****)
|
______________________
***** 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.
FSAD
CRO Toolkit Components
Component
|
Description
|
Configuration
Editor
|
(*****)
|
Image
Sort and Inspection System (ISIS)
|
(*****)
|
Workflow
Editor
|
(*****)
|
Automated
Task Execution
|
(*****)
|
Manual
Task Execution
|
(*****)
|
(*****)
|
(*****)
|
Exception
Handler
|
(*****)
|
Dataset
Manager
|
(*****)
|
Biomarker
Reporter
|
(*****)
|
Workbook
Manager
|
(*****)
|
User
Management
|
(*****)
|
Audit
Trail Viewer
|
(*****)
|
Workflow
Database
|
(*****)
|
User
Database
|
(*****)
|
IVUS
CRO Toolkit Components (upon
completion)
Component
|
Description
|
Video
Input Software
|
(*****)
|
Video
Editing Software
|
(*****)
|
Reporting
Software
|
(*****)
|
Exception
Handler
|
(*****)
|
User
Management
|
(*****)
|
Audit
Trail Viewer
|
(*****)
|
Workflow
Database
|
(*****)
|
User
Database
|
(*****)
|
______________________
***** 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.
Endometriosis
Toolkit Components
Component
|
Description
|
Endometriosis
Application
|
(*****)
|
Skin
Flare Toolkit Components
Component
|
Description
|
Skin
Flare Application
|
(*****)
|
Preclinical
Toolkit Components
Component
|
Description
|
VsVision
|
Research
application for loading images, identifying regions, manipulating
the
images and regions, and calculating information from the images and
regions.
|
RA
CRO Toolkit Components (upon
completion)
Component
|
Description
|
Configuration
Editor
|
(*****)
|
Image
Sort and Inspection System (ISIS)
|
(*****)
|
Workflow
Editor
|
(*****)
|
Automated
Task Execution
|
(*****)
|
Medical
Editor
|
(*****)
|
Exception
Handler
|
(*****)
|
Dataset
Manager
|
(*****)
|
Biomarker
Reporter
|
(*****)
|
Workbook
Manager
|
(*****)
|
User
Management
|
(*****)
|
Audit
Trail Viewer
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
(*****)
|
______________________
***** 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.
B. Description
of Documentation to be Provided:
For
each
of the Windows and Web applications in the CRO Toolkit Components listed in
the
sections above, there will be a user’s guide. In addition, there will be one
document entitled “Production Platform Installation Guide” describing how to set
up the system.
C. Form
in which Licensed Toolboxes Will Be Delivered:
The
system will be stored in a technology escrow at Iron Mountain. Iron Mountain
is
able to accept the information to be released electronically over a secure
web
channel. VirtualScopics will upload versions of the CRO Toolkits (including
documentation) to Iron Mountain quarterly or upon release of a new version,
whichever is less frequent. If the release conditions are met, then Pfizer
will
be given a link (by Iron Mountain) to download the information stored at Iron
Mountain.
D. Toolbox
Platform Required to Operate the Licensed Toolboxes:
The
system requirements are detailed in the installation guide, but here is a
summary:
1.
|
A
Windows Server acting as a domain controller, running Windows 2000
Server
or Windows Server 2003.
|
|
2.
|
A
Windows Server acting as a database server, running Windows 2000
Server or
Windows Server 2003, and Microsoft SQL Server 2000. (Can be the same
server as the domain controller.
|
|
3.
|
A
Windows Server acting as a Web Server, running Windows 2000 Server
or
Windows Server 2003, and IIS. (Can be the same server as either of
the
above).
|
|
4.
|
Workstations
that are part of the system should be running Windows 2000 Professional
or
Windows XP Professional. 512 MB of RAM is required, but 1GB is
recommended.
|
|
5.
|
(*****)
|
|
6.
|
(*****)
|
E. Acceptance
Criteria for Toolboxes:
As
defined in individual POPs and in Escrow Agreement.
II. Maintenance:
Telephone
Support.
VirtualScopics shall provide telephone support for the Licensed Toolboxes from
9:00 a.m. EST until 5:00 p.m. EST Monday through Friday. The telephone support
shall be provided by individuals thoroughly trained in the use of the Licensed
Toolboxes.
______________________
***** 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.
Enhancements.
Enhancements are included as part of Maintenance as long as they are implemented
and distributed during the Maintenance Term.
Scope.
Maintenance shall not include support, troubleshooting and repair of
hardware.
Error
Classification & Response Time: VirtualScopics
shall respond to a Pfizer’s inquiries regarding errors, bugs, and problems with
the Licensed Toolboxes ("Errors") within eight (8) business hours (for Errors
defined below as Critical Business Impact or Serious) of receipt of such
inquiry. VirtualScopics shall use commercially reasonable efforts to correct
Errors with a level of effort (including dedication of more senior level
personnel) commensurate with the classification of the Error as
follows:
Severity
Level
|
Criteria
|
VirtualScopics
Response
|
Critical
Business Impact
|
Errors
that substantially limit the ability to use the Licensed Toolboxes
as
intended including problems that cause the Licensed Toolboxes to
be down
or constantly crashing, problems of severe data corruption, or other
problems that are so severe that Pfizer cannot reasonably continue
to work
with the Licensed Toolboxes.
|
(*****)
|
Serious
|
Errors
that have a serious impact on Pfizer’s ability to use the Licensed
Toolboxes as intended, however, Pfizer is able to continue some portion
of
its work with the Licensed Toolboxes. Such Errors may include critical
features that are disabled or unstable and unreliable operation and
functioning.
|
(*****)
|
Non-Critical
|
Errors
that result in a minor loss or interruption of features or functionality
which do not significantly impair Pfizer’s general use of the Licensed
Toolboxes.
|
(*****)
|
On-Site
Support: Notwithstanding
anything to the contrary contained herein, if VirtualScopics is unable to
reproduce an Error classified as a Critical Business Impact within twenty-four
(24) business hours of receipt of Pfizer’s notification, VirtualScopics shall,
upon Pfizer’s request, provide on-site service to Pfizer within the next
business day to determine the cause of the error.
______________________
***** 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.
Notwithstanding
anything to the contrary contained herein, if VirtualScopics is unable to
reproduce an Error classified as a Serious Error within forty (40) business
hours of receipt of Pfizer’s notification, VirtualScopics shall, upon Pfizer’s
request, provide on-site service to Pfizer within the next business day to
determine the cause of the error.
Exhibit
B
FEES
(prices
may be subject to a 5% annual increase)
Toolbox
Development Services Fees
To
be
determined on an individual contract basis.
Maintenance/Support
Fees
Upon
the
request of Pfizer, VS will provide support for a CRO Toolbox installed at Pfizer
(listed in Exhibit A) at the hourly rates outlined below.
Escrow
Fees
$10,000
-
Annual charge
FTE
Annual Services Fees
Groton
|
$275,000
|
Xxx
Arbor
|
$265,000
|
Image
Analysis Services Fees (per analysis/timepoint)
|
||
Std. Rate
|
Pfizer
Discounted Rate
|
|
Oncology:
|
||
Structural
|
*****
|
****
|
Perfusion
|
****
|
****
|
Std. Rate
|
Pfizer
Discounted Rate
|
|
OA:
|
||
Standard
human cartilage analysis
|
****
|
****
|
-
volume
|
||
-
thickness
|
||
-
surface area
|
||
-
denuded area
|
||
Consulting
Hourly Rates
|
Std
Rate
|
Pfizer
Discounted Rate
|
MD/PhD
|
****
|
****
|
Software
Developer
|
****
|
****
|
Project
Manager
|
****
|
****
|
Image
Analysts
|
****
|
****
|
______________________
***** 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.