FUJI FILM
I & I Imaging & Information
EXHIBIT 10.1
Software Development Agreement
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Revised Nov 12, 2003
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FUJIFILM Medical Systems USA (Fuji), and Integrated Surgical Systems (ISS) agree
to work together on developing an integrated 2D and 3D Orthopedic pre-Surgical
planning software which will be integrated in Fuji's Synapse(TM) product. The
proposed approach is to base the software development on the existing
Orthodoc(TM) technology and derivatives from ISS.
Since the Orthodoc(TM) product is currently based on CT scans (3D planning), it
is agreed that Fuji and ISS will work together to add traditional X-ray based 2D
and the required additional 3D planning features. At the end of this development
both 2D and 3D Orthopedic planning features shall be available in Synapse.
The essential software development process proposed is as follows:
o ISS shall reuse its core software libraries currently developed for
Linux operating system and validate the functionality on windows
platform.
o ISS and Fuji shall work together to develop software directly for
Fuji's Synapse product. This software shall provide the application
level layer and will run directly in the Synapse environment. The
software shall use the functionality from the core software libraries.
Since current Orthodoc technology supports driving the Robodoc(TM) system, it is
agreed that all capability to control or drive the Robodoc system shall not be
available in the integrated product as part of this agreement. Ability to
integrate the Robodoc, if desired, shall be considered a separate project.
To accomplish this task, the following approach is proposed:
1. Clarify customer requirements for traditional 2D X-ray based planning
features as well as requirements for additional 3D planning and
develop requirements for the software. Included in this task is the
following:
a. Fuji to identify customers who will be interviewed
b. ISS will supply two Orthodoc systems to help demonstrate the
current features as well as receive comments from the
customers.
c. ISS and Fuji will dedicate resources to accomplish this task
d. This activity may involve travel to Fuji's customers as well
as to agreed upon tradeshows (such as RSNA and AAOS) where a
larger group of Fuji's customers may be interviewed
e. Costs associated with trade show support shall be considered
separately.
f. This activity is contingent upon receiving initial positive
comments from Fuji customers traveling to Sacramento and
meeting with Xx. Xxxxxx.
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2. Develop a technical architecture and plan (Interface Control Document)
a. Fuji and ISS engineering will work together to develop an
architecture and a development plan for the total product
which not only includes the software features for surgical
planning but also an integration strategy with Fuji's
Synapse product. b. This activity is contingent upon
receiving positive comments from Fuji customers.
3. Develop alpha prototype using agreed upon development process
a. Initial software design and testing
b. Initial integration with Synapse
c. Review software with key customers
d. Determine finalization plan
4. Complete beta development
a. Beta release for final customer review and final testing
b. Data collection for submission
5. USA Regulatory Submission
a. Parallel to development, determine USA regulatory submission
requirements
b. If submission is required then proceed with submission
6. International Regulatory submission
a. Parallel to develop, determine international requirements
b. Prepare submission
c. Submission to each country is to be determined separately
7. Complete Product development
a. Final release of system based on beta prototype for clinical
use
b. Final product with documentation
8. Localization
a. Fuji's Synapse product is a global product sold in
international markets. The software architecture shall allow
for language translation of the user interfaces such as
menus, dialog boxes etc. Initial releases shall be in the
following languages:
i. English
ii. Japanese
iii. French
iv. Italian
v. German
vi. Chinese
b. ISS and Fuji shall agree upon the proper technical approach
for localization (local language requirements) of the
jointly developed software
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c. ISS and Fuji shall agree upon the proper process to localize
ISS developed software if a version for the requested
language does not exist.
d. Local implant manufacturer support shall be considered in
the overall design.
i. ISS may negotiate separately to develop implant support
for manufacturers not currently supported
ii. Fuji may request (as a separate project) that ISS
develop implants for a specific manufacturer. Costs to
be negotiated separately.
9. Software maintenance and updates
a. Develop a process to allow Fuji to request changes to the
software based on customer feedback b. Develop a process
where ISS continues to release new capabilities c. Cost of
maintenance and updates to be discussed at a later time.
Fuji and ISS agree to work in good faith to keep maintaining
the products to state of the art features and technology.
10. Licensing fees
a. Licensing fees shall include all the features of the
software. No segregation of 2D and 3D is being considered.
b. Fuji and ISS shall work in good faith to determine
appropriate licensing fees paid to ISS for the core
libraries.
11. Cost structure
a. ISS and Fuji shall develop a mutually acceptable cost
structure and cost schedule for this project
b. Runtime licensing and maintenance costs shall also be agreed
upon.
c. Execution of this agreement is dependent upon acceptable
development costs as stated in Appendix A.
12. Exclusivity
a. ISS agrees to offer the 2D and 3D integrated software
developed for Synapse in conjunction with Fuji exclusively
to Fuji to Market to Fuji's existing and future customers.
b. ISS has the right to continue to offer its Orthodoc product
to any customer.
c. ISS shall not engage in a similar development with a
competitor of Fuji during the development period.
d. ISS shall not offer the windows port of core technology to a
Fuji competitor for a minimum of 18 months.
e. Exclusivity begins from the date of this agreement
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13. Cancellation
a. Fuji reserves the right to cancel this agreement with a 30
day written notice at any time during the development.
b. ISS reserves the right to cancel this agreement with a 30
day written notice at any time during the development.
c. If either side cancels the agreement, the items stated in
Intellectual Property shall still apply.
d. If Fuji chooses to cancel the agreement, Fuji shall
reimburse ISS for the work that is completed and not any
work that is not completed
e. If ISS chooses to cancel the agreement, Fuji shall not
reimburse ISS for any completed and uncompleted work as Fuji
will also incur a loss of time and resources spent.
14. Disclosure and confidentiality
a. ISS agrees to disclose to Fuji if it is engaged in any
relationship with Fuji's competitors during this agreement
period.
b. Fuji agrees to disclose to ISS if it is engaged in any
relationship with ISS's competitors during this agreement
period.
c. If ISS engages in a relationship with Fuji's competitors,
Fuji may decide to exercise its right to cancel this
agreement
d. If Fuji engages in a relationship with ISS's competitors,
ISS may decide to exercise its right to cancel this
agreement.
e. This agreement and its contents shall be considered
confidential by ISS and Fuji and not be disclosed to any
other third party without consent from Fuji and ISS.
f. In addition to this agreement, Fuji and ISS agree to sign a
Non-Disclosure Agreement. Upon signing the non disclosure
agreement shall be automatically extended to Fuji and ISS
personnel who will be exposed to the confidential
information.
15. Intellectual Property
a. Any knowledge gained by ISS about Fuji's Synapse system
shall be considered confidential and proprietary
information. ISS shall not disclose such information to any
organization except a direct healthcare organization without
Fuji's permission.
b. Conversely, any knowledge gained by Fuji about ISS's
Orthodoc product shall be considered proprietary and shall
be shared only with Fuji's customers
c. Any current ISS software that is ported shall be the
intellectual property of ISS.
d. Software developed specifically for the Synapse application
shall be the property of Fuji and ISS agrees to not disclose
the details of the software to anyone without Fuji's
permission.
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e. Any algorithms or high-level design performed jointly by ISS
and Fuji shall be the intellectual property of both Fuji and
ISS.
f. Any algorithms or high-level design performed by ISS shall
be the intellectual property of ISS
g. Any algorithms or high-level design performed by Fuji shall
be the intellectual property of Fuji.
16. Third party agreements
a. If Fuji has prior agreements of confidentiality with
suppliers of technology to Fuji, those agreements shall be
agreed to by ISS. Fuji may require ISS to sign
confidentiality agreements on behalf of the suppliers.
b. If ISS has prior agreements of confidentiality with
suppliers of technology (e.g with implant manufacturers) of
confidentiality, those agreements shall be agreed to by
Fuji. ISS may require Fuji to sign confidentiality
agreements on behalf of the suppliers.
17. Escrow
a. ISS agrees to allow Fuji to place the windows port of ISS
software into Escrow if for whatever reason ISS decides to
exit the business, or no longer supports the software, or
another company purchases ISS and that company decides not
to support this software.
18. Agreement period
a. The period of this agreement is currently stated in Appendix
A. It is to be considered as an estimate.
b. Changes to the agreement shall be agreed to by Fuji and ISS
whenever estimated schedules are delayed.
19. Payment terms
a. Work mentioned in the agreement shall begin after the first
payment is received by ISS.
b. Standard payment terms are net 30 days after receipt of
invoice.
Agreed by,
By: /s/ Xxxx Xxxxxx 11/17/03 By: /s/ Xxxxxx Xxxxxxx 11/17/03
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Xxxx Xxxxxx Date Xxxxxx Xxxxxxx Date
Vice President of CEO
Marketing and Integrated Surgical
Development Systems
FUJIFILM Medical
Systems USA
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APPENDIX A
Payment process:
Project costs are categorized as follows:
o Verification of Linux libraries on Windows platform. Costs include
software engineering and testing resources
o Joint development of application functionality. Costs include software
engineering and testing resources.
o Costs incurred for Market specification development
o Assistance to Fuji for any regulatory documentation
The payments are made before the next activity starts provided that previous
activity has been completed to Fuji's satisfaction. ISS shall invoice against a
Fuji purchase order for each item in the purchase order as listed below.
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Payment Amount Activity Estimated Duration
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1 $200K Get started with windows verification of 1 Month from start for market
libraries and market specification spec.
2 months from start for
Complete market specification, develop a technical architecture
technical architecture,
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2 $200K complete library verification effort and 4 months from start for
prototype verification
5 months from start for
prototype
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3 $240K Complete beta software 9 months from start
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4 $150K Deliver commercial software, necessary 13 months from start
regulatory documentation
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Total $790K
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ISS prefers a wire transfer form of payment method.
Bank of America
000 Xxxxxxx Xxxx
Xxxxxxxxxx, XX 00000
Swift Code: BofAUS6S
ABA Routing Number: 000000000
Account Number: 14990-08126
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