Software License Agreement - Segami Corp. and Digirad Corp.
SOFTWARE LICENSE AGREEMENT
This Software License Agreement ("Agreement") is entered into under
seal this 16th day of June, 1999 (the "Effective Date") by and between Segami
Corporation, a Maryland corporation having its principal offices at 12624 Golden
Oak Drive, Ellicott City MD 21042 ("Segami"), and Digirad Corporation
("Digirad"), a Delaware corporation having its principal offices at 9350 Trade
Place. San Diego CA 92126.
Statement of Intention
A. Segami is in the business of the development and sale of
software for gamma camera image acquisition, processing and
display. Segami's current software is called Mirage.
B. Digirad desires to purchase software from Segami for the
purpose of gamma camera image acquisition, processing and
display which will interface with Digirad's solid state gamma
camera.
C. Digirad desires to package the Mirage software and Digirad's
hardware for resale as a single product, identifiable only as
a Digirad product.
In consideration of the mutual promises and covenants herein contained,
the receipt and sufficiency of which are hereby acknowledged, the parties agree
under seal as follows:
1. DEFINITIONS. For the purposes of this Agreement, the following
terms, when used herein, have the following meaning.
"Base Software"-The existing Mirage software described in EXHIBIT D hereto in
object and executable code forms, and all updates, enhancements, revisions,
modifications, modules and or sub-modules thereto and all permitted copies,
except that Base Software does not include the Interface Development.
"Interface Development"-The new code written and modifications made to the Base
Software which will allow use of the Base Software with Digirad's current
hardware, in object and executable code forms, and all updates, enhancements,
revisions, modifications, modules and or sub-modules thereto and all permitted
copies.
"Product" - Digirad's solid state gamma camera bundled together with the Base
Software and Interface Development.
2. LICENSE TO DIGIRAD. Subject to all the terms of this
Agreement, Segami grants to Digirad a nonexclusive worldwide, fully paid-up
license:
(a) to sublicense the Base Software to end-users only in
connection with the sale and use of the Products; any such sublicense shall be
pursuant to a sublicense agreement for Segami's
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benefit that contains applicable similar restrictions and obligations imposed on
Digirad hereunder.
(b) to use, adopt, reproduce, display, perform, test, demonstrate
and distribute the Base Software as necessary to market, sale and distribute the
Products.
(c) sublicense to third parties the distribution rights for the
Products and Base Software; any such sublicense shall be pursuant to a
sublicense agreement for Segami 's benefit that contains applicable similar
restrictions and obligations imposed on Digirad hereunder.
The balance of this Section 2 notwithstanding, the license granted to Digirad
shall not include the right to sublicense, sell or distribute the Base Software
independently and separate from the Product, with the understanding that Digirad
may demonstrate the Base Software or distribute demonstration models of the Base
Software, limited in function, for use on systems independent from the Product.
3. USE/LICENSE FEES.
3.1 USE. Segami hereby grants Digirad the right to
package and bundle the Base Software with the Product, the Interface Development
and Digirad hardware for sale to end-users by Digirad or its subdistributors.
3.2 LICENSE FEES. Digirad shall pay a License Fee (the
"License Fee") to Segami, in accordance with the attached Exhibit A, for each
copy of the Base Software distributed to any end-user, unless otherwise agreed
upon in writing by Segami. Payment of the License Fee shall be made by Digirad
and tendered to Segami at the sooner of thirty (30) days after customer payment
or seventy-five (75) days after customer installation. Digirad will receive a
reasonable number of demonstration versions of the Base Software including the
dongle keys ("Keys") for using such versions ("Demo Versions") to be used for
customer demonstrations and/or Digirad roadshows (not for sale to customers).
Segami shall deliver the Demo Versions within 30 days upon written request from
Digirad.
3.3 AUDIT. Segami shall have the right to audit the
books, financial accounts and documents of Digirad one (1) time in each calendar
year for which this contract is in force, to verify the number of copies of the
Base Software disseminated by Digirad. Segami shall employ an independent
Certified Public Accountant at its own cost and expense for such audit. Segami
shall give Digirad a minimum of ten (10) days prior written notification of the
audit. Digirad shall not unreasonably withhold its cooperation in the audit.
4. INTERFACE DEVELOPMENT.
4.1 DEVELOPMENT. Segami agrees to undertake and complete
the code design, programming and testing of the Interface Development. Interface
Development shall be in accordance with the specifications on the attached
Exhibit B (the "Specifications") and the delivery schedule attached hereto as
Exhibit C (the "Delivery Schedule"). Segami shall be
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responsible for obtaining and maintaining operational status and approvals of
the Base Software and Interface Development (and any new versions or
improvements thereto) under FDA, CE and other regulatory authorities or
agencies. Segami agrees that its conduct in performing its obligations under
this Agreement shall conform in all material respects to all applicable laws and
regulations of the U.S. and foreign governments (and political subdivisions
thereof).
4.2 ACCEPTANCE. Digirad will, by written notice, accept
or reject any portion of the Interface Development delivered (individually, the
"Deliverable(s)") within thirty (30) days after receipt. Failure to give notice
of acceptance or rejection within that period will constitute acceptance.
Digirad may reject any Deliverable only if the Deliverable fails to meet the
Specifications or, at the fault or failing of that Deliverable alone, the
Product cannot operate in a commercially reasonable manner. If Digirad properly
rejects the Deliverable, Segami will correct the failures properly specified in
the rejection notice within fifteen (15) days of the rejection notice. When it
believes that it has made the necessary corrections, Segami will again deliver
the Deliverable to Digirad and the acceptance/rejection/correction provisions
above shall be reapplied until the Deliverable is accepted; provided, however,
that upon the third or any subsequent rejection or if the corrections are not
made within thirty (30) days of the initial rejection, Digirad may at its
option terminate this Agreement by immediate written notice unless the
Deliverable is accepted during the notice period.
5. COMPENSATION FOR INTERFACE DEVELOPMENT. Digirad shall make
payments to Segami in accordance with the Delivery Schedule. Each payment will
be in U.S. dollars from the United States and will be made no later than 30 days
from the occurrence of the event specified in the Delivery Schedule for which
payment is due.
6. OWNERSHIP RIGHTS. As between the parties Segami shall retain
all right title and interest, including all patent, copyright, trade secret,
trademark, mask work or other rights, in the Base Software, or any other idea or
product conceived or reduced to form by Segami, its agents or assigns as of the
Effective Date. Digirad shall have all right, title and interest, in the
Interface Development. The parties hereby make any assignments necessary to
accomplish the foregoing ownership provisions.
7. SUPPORT/MAINTENANCE.
7.1 SUPPORT. During the term of this Agreement:
(1) Segami shall use its best efforts to respond
within ten (10) days after receipt of written notice of verifiable defects, and
propose a plan for prompt and effective remedy, and shall provide general
guidance concerning the Base Software or Interface Development. Defects shall be
reported in writing via electronic mail or facsimile to Segami at the
telephone/email numbers provided by Segami to Digirad from time to time.
(2) Segami shall inform Digirad promptly of any
changes in the Base Software or delivery schedules.
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(3) Subject to the other terms and conditions of
this Agreement, Segami shall use its reasonable best efforts to promptly fill
Digirad's orders for Keys. Promptly following the execution of this Agreement,
Segami shall place thirty (30) Keys in escrow. If Segami materially fails to
provide a sufficient number of Keys to Digirad for delivery of Products to
end-users, after thirty (30) days written notice to Segami, Digirad shall be
entitled to receive from escrow any or all of the Keys. If Segami fails to
provide a sufficient number of Keys to Digirad for delivery of Products to
end-users, after seventy-five (75) days written notice to Segami, Digirad shall
be entitled to a fully executed purchase order from Segami to the Key
manufacturer ("Escrow Materials") authorizing the Key manufacturer to provide
directly to Digirad those Keys reasonably necessary, in Digirad's sole
discretion, for Digirad to sell and install Product. In support of the foregoing
and promptly after execution of this Agreement, Segami will place in escrow
(pursuant to the terms of an escrow agreement in form mutually acceptable to the
parties hereto) the Escrow Materials as they exist at the date of the Agreement.
Segami will update the escrow with any new or modified Escrow Materials and Keys
promptly as it becomes necessary and will notify Digirad when it does so. All
escrow fees will be borne by Digirad.
(4) Segami agrees to provide one standard
training program for Digirad personnel. Such program shall be given at Digirad's
main office on a schedule reasonably acceptable to Segami but commencing no
later than sixty (60) days after Digirad's written request. Digirad shall bear
Segami's out-of-pocket travel costs in connection with the program including air
travel, room and board.
(5) Segami shall provide free technical support
to Digirad personnel up to 200 hours during the first year, and 100 hours per
year after that. This does not include time spent on developments set forth in
Section 4 or Section 7.1(1). Segami shall provide Digirad with all the user's
documentation in its possession.
7.2 MAINTENANCE RELEASES. In the exercise of its sole
discretion and from time to time, Segami may develop and make available
maintenance release for the Base Software at no cost to Digirad. Such
maintenance release shall be patches for the purpose of correcting any
deficiencies in the Base Software which may become apparent to Digirad and
Segami after successful delivery of the Interface Development.
7.3 ENHANCEMENTS/UPGRADES. In the exercise of its sole
discretion and from time to time, Segami may develop and make available for sale
through Digirad to end-users, and at an additional license fee to Segami, to be
negotiated in good faith by the Parties, substantially upgraded versions of the
Base Software which incorporate significant functional changes or additions, or
substantially improved performance.
8. CONFIDENTIALITY. Each party agrees that all code, inventions
algorithms, know-how and ideas and all other business, technical and financial
information they obtain from the other are confidential information and property
of the disclosing party ("Confidential Information"). Each party shall use
Confidential Information of the other party which is disclosed to it only for
the purposes of this Agreement and shall not disclose such Confidential
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Information to any third party, without the other party's prior written consent,
other than to Segami's subcontractors, subdistributors and employees on a
need-to-know basis. Each party agrees to take measures to protect the
confidentiality of the other party's Confidential Information that, in the
aggregate, are no less protective than those measures it uses to protect the
confidentiality of its own Confidential Information, but at a minimum, each
party shall take reasonable steps to advise their employees, subcontractors and
subdistributors of the confidential nature of the Confidential Information and
of the prohibitions on copying or revealing such Confidential Information
contained herein. The parties each agree to require that the other party's
Confidential Information be kept in a reasonably secure location.
Notwithstanding anything to the contrary contained in this Agreement neither
party shall be obligated to treat as confidential, or otherwise be subject to
the restrictions on use, disclosure or treatment contained in this Agreement for
any information disclosed by the other party (the "Disclosing party") which: (1)
is rightfully known to the recipient prior to its disclosure by the Disclosing
Party; (2) is generally known or easily ascertainable by non-parties of ordinary
skill in computer process design or programming or in the business of the
client; (3) is released by the Disclosing Party to any other person, firm or
entity (including governmental agencies or bureaus) without restrictions; (4) is
independently developed by the recipient without any reliance on Confidential
Information; or (5) is or later becomes publicly available without violation of
this Agreement or may be lawfully obtained by a party from a non-party. Neither
party will be liable to the other for inadvertent or accidental -disclosure of
Confidential Information if the disclosure occurs notwithstanding the party's
exercise of the same level of protection and care that such party customarily
uses in safeguarding its own confidential information.
Notwithstanding the foregoing, all Confidential Information developed
by Segami, including but not limited to the Interface Development, in connection
with this Agreement shall be deemed Confidential Information of Digirad
disclosed by Digirad to Segami and exceptions (1) and (4) above will not be
applicable thereto.
9. EXPORT CONTROL. Each party hereby agrees to comply with all
export laws and restrictions and regulations of the Department of Commerce or
other United States or foreign agency or authority, and not to export, or allow
the export or re-export of any proprietary information or software or any copy
or direct product thereof in violation of any such restrictions, laws or
regulations.
10. TERMINATION
10.1 TERMINATION BY DIGIRAD. Digirad may terminate this
Agreement if Segami is in material breach of, or default under, this Agreement
and such breach or default is not cured within thirty (30) days after Digirad
delivers written notice of such breach or default to Segami.
10.2 TERMINATION BY SEGAMI. Segami may terminate this
Agreement if Digirad is in material breach of, or default under, this Agreement
and such breach or default is not cured within thirty (30) days after written
notice to Digirad. A material breach of and default
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under, this Agreement by Digirad shall include, without limitation, the
occurrence of the failure of Digirad to pay any License Fee when due.
10.3 SURVIVAL. Sections 5-15 of this Agreement, any
accrued rights to payment, any licenses granted in this Agreement that are
expressly perpetual and any remedies for breach of this Agreement shall survive
termination.
11. LIMITATION OF LIABILITY.
(a) Except under Section 8 and the indemnity provisions
of Section 12, neither party nor its affiliates shall, under any circumstances,
be liable to the other party or its affiliates for any claim based upon any
third party claim or for consequential, incidental, indirect, punitive,
exemplary or special damages of any nature whatsoever, or for any damages
arising out of or in connection with any malfunctions, delays, loss of data,
loss of profit, interruption of service or loss of business or anticipatory
profits, even if a party or its affiliates have been apprised of the likelihood
of such damages occurring.
(b) Segami shall not be liable for the actions of any
end-users who rely on the images produced by the Product as a diagnoses without
the aid of independent professional medical judgment or who does not operate the
Product under the direct supervision of a board certified nuclear medicine
physician. Digirad shall be responsible for supplying the end-user with a notice
of limitation of liability in writing and in language consistent with this
Section 11 (b).
12. INDEMNIFICATION
(a) The parties each agree to indemnify, defend and hold
harmless the other from and against any and all amounts, including legal fees
and other out-of-pocket expenses, payable under any judgment, verdict, court
order or settlement for death or bodily injury or the damage to or loss or
destruction of any real or tangible personal property to the extent arising out
of the indemnitor's negligence, gross negligence, or willful misconduct in the
performance of this Agreement.
(b) Segami agrees to indemnify, defend and hold harmless
Digirad, its distributors and end-users from and against any and all amounts,
including legal fees and other out-of-pocket expenses, payable under any
judgment, verdict, court order or settlement to the extent resulting from any
third party allegation that the Base Software or the work performed by Segami
under this Agreement infringes such third party's intellectual property rights,
including, without limitation, patent, copyright or trade secret. Should
Digirad's use of work performed by Segami be determined to have infringed, or if
in Segami's and Digirad's reasonable judgment such use is likely to be
infringing, Segami may, at its option: (1) procure for Digirad the right to
continue to use the work performed by Segami; or (2) replace or modify the work
performed by Segami to make its use non-infringing while yielding substantially
equivalent results. If neither of such options are or would be available on a
basis that Segami finds commercially reasonable, Segami may terminate this
Agreement, Digirad shall return infringing work performed to Segami and Segami
shall refund the fees paid for the associated services. Digirad reserves any
other legal or equitable rights or remedies in may have. This indemnity does not
cover alleged infringements caused by modifications to the work performed by
Segami that are not made by Segami or that result from Digirad provided designs
specifications or other information or from combination of such work with
products or services not provided by Segami.
(c) Digirad agrees to indemnify, defend and hold harmless
Segami from and against any and all amounts payable under any judgment, verdict,
court order or settlement to the extent resulting from any affiliated third
party allegation that the work performed by Segami under this Agreement
infringes such third party's intellectual property rights to the extent
attributable to software, hardware, data, knowledge or services provided by
Digirad.
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(d) The indemnities in this paragraph are contingent
upon: (1) the indemnified party promptly notifying the indemnifying party in
writing of any claim which may give rise to a claim for indemnification
hereunder; (2) the indemnifying party being allowed to control the defense and
settlement of such claim; and (3) the indemnified party cooperating with all
reasonable requests of the indemnifying party (at the indemnifying party'
expense) in defending or settling such claim. The indemnified party shall have
the right, at its option and expense, to participate in the defense of any
action, suitor proceeding relating to such a claim through a counsel of its own
choosing.
13. WARRANTIES. Segami warrants that it has and will obtain
agreements with its employees and contractors sufficient to allow it to provide
Digirad with the assignments and licenses to intellectual property rights
contemplated in this Agreement. Segami also warrants that the Base Software and
Interface Development and any part thereof shall meet the Specifications, and
perform in a commercially reasonable manner until the later of (i) four (4)
years from the final date of delivery on the Delivery Schedule and (ii) with
respect to each product containing the Base Software and/or Interface
Development, one (1) year from the date of installation of such product by
Digirad or its distributor to an end-user. If Digirad finds that the Products,
or part thereof fail to meet the above warranty, Segami shall, at its option,
immediately repair or replace the Base Software and/or Interface Development or
part thereof at its costs and expenses without prejudice to any other rights and
remedies of Digirad under this Agreement or applicable law. If a Deliverable is
rejected, the warranty will extend accordingly from any adjusted final delivery
date. Except for Section 14, notwithstanding anything to the contrary contained
in this Agreement, Segami makes no other warranties, express or implied, or
whether arising by operation of law, course of performance or dealing, custom,
usage in the trade or profession or otherwise including without limitation
implied warranties of merchantability and fitness for a particular purpose.
14. MILLENNIUM WARRANTY.
14.1 GENERAL, Other sections of this Agreement
notwithstanding, Segami represents and warrants that for a period of four (4)
years after the Effective Date, the Base Software and the Interface Development
will be able to accurately: (a) process any date-roll event with no adverse
impact on the functionality of the software including without limitation, the
producing of error(s) or abnormal interruption; (b) process date-data
calculations including, without limitation, computation, comparisons,
sequencing, sorts and extracts and return and display date-data in a consistent
manner regardless of the dates used in such date-data whether before, on,
during, or after January 1, 2000; (c) process any date-data computations that
can be expected from the software if used for its intended purpose, regardless
of the date in time on which the processes are actually performed and regardless
of the date-data input, whether before, on, during or after January 1, 2000; (d)
exchange date-data related information with other hardware, firmware or software
with which it interacts, provided that the interacting hardware, firmware or
software is itself capable of exchanging accurate date-data; (e) accept and
respond to four-digit year-date input in a manner that resolves any ambiguities
as to the century in a defined predetermined and appropriate manner; and (f)
store and display date-data in ways that are unambiguous as to the determination
of the century. No date-data shall cause such software to
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perform an abnormally ending routine or function within the processes or
generate incorrect values or invalid results. For purposes of the foregoing, a
date-rollover event is defined as any transaction between one calendar year and
the following calendar year including, without limitation, any time, date and
day-of-the-week progressions and any regularly scheduled leap events. Date-data
is defined as any data, formula, algorithm, process, input or output, which
includes, calculates or represents a date, day or time, a reference to a date,
day or time, or a representation of a date, day or time.
14.2 SPECIAL REMEDIES. In the event of any breach of the
warranties and covenants contained in this section, provided that such breach is
not cured by Segami within fourteen (14) calendar days following receipt of
written notice of such breach, in addition to other rights and remedies that may
be available to Digirad under this Agreement, Segami shall be responsible for:
(a) any costs of repairing, replacing and/or correcting the affected software;
and (b) cover and other similar damages that are incurred by Digirad as a result
of Segami's breach of this warranty.
15. MISCELLANEOUS
15.1 BINDING NATURE. This Agreement shall be binding upon
and shall inure to the benefit of the parties to this Agreement and their
respective successors and permitted assigns. Segami shall not have any right or
ability to assign, transfer, or sublicense any obligations or benefit under this
Agreement without the written consent of Digirad, except that Segami may assign
and transfer this Agreement and its rights and obligations hereunder to any
third party who succeeds to substantially all its business or assets.
15.2 ENTIRE AGREEMENT. This Agreement constitutes the
entire agreement between the parties and there are no representations,
warranties, covenants, or obligations except as set forth in this Agreement.
This Agreement supersedes all prior or contemporaneous agreements
understandings, negotiations and discussions, written or oral, of the parties to
this Agreement, relating to any transaction contemplated by this Agreement.
15.3 SEVERABILITY. Each provision of this Agreement shall
be considered separable and if for any reason any provision or provisions in
this Agreement are determined to be invalid arid contrary to any existing or
future law, that invalidity shall not impair the operation of this Agreement or
affect those portions of this Agreement which are valid.
15.4 ARBITRATION. If any dispute or controversy arises
among the parties to this Agreement concerning any provision of this Agreement,
that dispute or controversy shall be submitted for resolution to a board of
arbitration in Baltimore, Maryland if Digirad initiates the dispute and in San
Diego, California if Segami initiates the dispute, composed of one member
selected by each party, and a third mutually agreed upon. Such arbitration shall
be conducted pursuant to the rules of the American Arbitration Association (the
"AAA") or other governing rules and a decision of the board of arbitration
(including an award of costs of the board) shall be final and binding upon the
parties.
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15.5 NO AGENCY. This Agreement shall not be deemed to
constitute the parties hereto as partners, joint venturers, nor shall either
patty hereto be deemed to be an agent of any nature, kind and description
whatsoever of the other.
15.6 JURISDICTION AND VENUE. This Agreement shall be
governed, enforced, performed and construed in accordance with the laws of the
State of Maryland (excepting those conflicts of laws provisions which would
serve to defeat application of Maryland substantive law). Subject to the
provisions of Section 15.4 hereof each of the parties hereto hereby submits to
the exclusive jurisdiction of the state and/or federal courts located within the
State of Maryland for any suit, hearing or other legal proceeding of every
nature, kind and description whatsoever in the event of any dispute or
controversy arising hereunder or relating hereto, or in the event any ruling,
finding or other legal determination is required or desired hereunder.
15.7 ATTORNEYS FEES. In the event that legal proceedings
are commenced in connection with this Agreement or the transactions contemplated
hereby, the party or parties which do not prevail in such proceedings shall pay
the reasonable attorneys fees and other costs and expenses, including
investigation costs, incurred by the prevailing party in such proceedings.
15.8 AMBIGUITY. The parties acknowledge that each party
and its respective counsel have reviewed and revised this Agreement and that the
normal rule of construction to the effect that any ambiguities are to be
resolved against the drafting party shall not be employed in the interpretation
of this Agreement or any amendments or exhibits, or schedules hereto.
15.9 EXHIBITS. The exhibits attached hereto and each
certificate, schedule, list summary or other document provided or delivered
pursuant to this Agreement or in connection with the transactions contemplated
hereby are incorporated herein by this reference and made a part hereof.
15.10 COUNTERPARTS. Provided that all parties hereto
execute a copy of this Agreement, this Agreement may be executed in
counterparts, each of which shall he deemed an original and all of which
together shall constitute one and the same instrument. Executed copies of this
Agreement may be delivered by facsimile transmission or other comparable
electronic means.
15.11 VOLUNTARY AGREEMENT. The parties hereto represent
that they have carefully read the foregoing Agreement, understood its terms,
consulted with an attorney of their choice, and voluntarily signed the same as
their own free act with the intent to be legally bound thereby. The terms of
this Agreement are contractual and not a mere recital.
15.12 FORCE MAJEURE. Neither party shall be liable to the
other for its failure to perform any of its obligations under this Agreement
during any period in which such performance is delayed due to circumstances
beyond its control, including acts of God or public authorities, was and war
measures, civil unrest, natural disasters or delays in transportation, delivery
or supply.
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15.13 NOTICE. All notices under this Agreement shall be in
writing and shall be deemed given when personally delivered or three days after
being sent prepaid certified or registered United States mail to the address of
the party to be noticed as set forth below or such other addresses as such party
last provided to the other by notice:
Digirad: Digirad Corporation
9350 Trade Place
San Diego CA 92126
Attn: President and COO
Segami: Segami Corporation
12624 Golden Oak Drive
Ellicott City MD 21042
Attn: Philippe Briandet Ph.D.
Copy to: Christopher S. Young, Esq.
3440 Ellicott Center Drive
Ste. 203
Ellicott City MD 21043
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed
under seal as of the date first above written.
ATTEST: Digirad Corporation
By: /s/ ILLEGIBLE By: /s/ Scott Huennekens
------------------------------- --------------------------------
Title: Controller (SEAL) Title: President & COO
---------------------------- -----------------------------
Segami Corporation
By: /s/ ILLEGIBLE (Secretary) By: /s/ ILLEGIBLE
------------------------------- ------------------------------
Title: (SEAL) Title: President
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EXHIBIT A
PRICING SCHEDULE
FEES: PLANAR IMAGING SPECT IMAGING
UNITS 1-20 $***/unit + $***/unit
21-50 $***/unit + $***/unit
51-100 $***/unit + $***/unit
101-250 $***/unit + $***/unit
251- $***/unit + $***/unit
Quantity pricing for the software shall be solely dependent upon the number of
planar imaging units purchased, and shall be cumulative throughout the life of
the Agreement. A minimum fee payment of *** dollars ($***) shall be paid by
Digirad to Segami each Agreement year, which shall be defined as July 1- June
30. The first Agreement year shall begin July 1, 1999. Any shipments made to
Digirad prior to July 1, 1999 shall be credited toward the minimum requirement
fee payment for the first Agreement year of July 1, 1999 - June 30, 2000. All
such minimum fee payments shall be payable in advance quarterly to Segami, and
shall be credited towards actual fee payments, without any time limit.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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EXHIBIT B
Written By: Richard Conwell & Alex Shek
Approval:
_________________________________ 5/25/99
Product Engineering Manager Date
_________________________________ 5/25/99
Quality Assurance Manager Date
REVISION HISTORY
RELEASE DATE CO# REV CHANGE
5/25/99 N/A 01 Initial Prototype Release
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Information contained in this document is proprietary to DIGIRAD Corporation and
should not be released outside of the company without written permission of the
company.
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1.0 INTRODUCTION
1.1 PURPOSE
This document details the software requirements that have been
established for the 2020TC Gamma Camera. These requirements shall be
used by the software developer(s) as software development requirements
to meet the design specification and software risk analysis mitigation
plan for the 2020TC Gamma Camera.
1.2 SCOPE
This document will outline the software design for the software data
interface, processing and diagnostic requirements of the 2020tc Gamma
Camera. This requirement specification covers the software programs
TBD.
1.2.1 The software shall be designed to run as service modules under Windows
NT and shall address these basic system goals:
a. Using a PLX Technology driver, interface Digirad's HotLink PCI
data acquisition card to a data acquisition and processing
module.
b. Perform data processing to:
- Decode raw data (32 bit word) into digital address,
energy and other status bits
- Apply energy correction (linearity and offset) and
spatial X-Y lookup
- Apply energy window(s) discrimination
- Apply "bad detector element" filter
- Continuously build image in a buffer memory
- Provide timing information from time stamps in the
data stream
- Interface to Segami Corporation's Mirage display,
control and imaging processing software.
c. Provide diagnosis modules whose functions shall be to provide
processing and a GUI interface for:
- Acquisition and display of an energy spectrum for any
selected detector element.
- Acquire and generate energy correction (linearity and
offset) for each detector element.
- Generation and editing of a "bad detector element"
listing.
- Generation of a sensitivity uniformity correction.
1.3 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS
1.3.1 2020TC - A solid state gamma camera with a 64 x 64-detector element,
quantized detector head.
1.3.2 Detector Element - The individual detectors of the quantized detector
head. Each detector element is approximately 3 mm x 3 mm in area and 6
mm thick.
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Information contained in this document is proprietary to DIGIRAD Corporation and
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1.3.2 Pd - Peripheral Component Interconnect. A parallel bus, personal
computer back plane interface standard.
1.3.3 MCA - Multi-Channel Analyzer. A system which tallies the frequency of a
stream of signal events as a function of the signal's magnitude. The
display of the tallied events takes the form of a histogram.
1.3.4 Energy Spectrum - The histogram of the frequency of a gamma ray photons
as a function of their energy.
1.3.5 Energy Window - The interval of gamma ray energy over which all gamma
rays falling within the interval are tallied.
1.3.6 Time Stamps - A timing mark embedded in a 32-bit digital word.
1.3.7 Bad Detector Element - A detector element in the detector head that is
not working within specification.
1.3.8 Active Detector Element - A detector element in the detector head that
is working within specification, and is not included in the bad
detector element file.
1.3.9 Detection Efficiency - The ratio, expressed as a percentage, of gamma
rays detected to those entering a detector element.
1.3.10 Intrinsic Sensitivity - The detection efficiency measured without a
collimator in place.
1.3.11 HOTLink - A high speed, serial communications link between the 2020tc
detector head and a PCI format interface board.
1.3.12 INA Board - An instrumentation amplifier system mounted on the HOTLink
transmitter board installed in the camera head case.
1.3.13 Energy Linearity - The numerical process of mapping the raw value of a
gamma ray photon's measured energy into a linear scale having units of
energy. In the 2020TC this process is accomplished with a simple -
order polynomial.
1.3.14 Energy Offset - The offset from zero of the linearized raw values of a
gamma ray photon's measured energy.
1.3.15 Flood Field - A planar source of gamma ray radiation.
1.3.16 Sensitivity Uniformity - The intrinsic variation in gamma ray photon
sensitivity of the individual detector elements of the 2020TC.
1.3.17 Digital Address - The unique numerical value assigned to each detector
element in the 2020tc detector head.
1.3.18 Spatial Address - The actual spatial location of a detector element
expressed as an X(Y coordinate.
1.3.19 Mirage Software - A gamma camera image processing software supplied by
Segami Corporation.
1.3.20 SPECTour Chair - A mechanized rotating chair assembly to which the
2020TC head is attached and in which a seated patient maybe imaged for
SPECT.
1.3.21 In this document the word "shall" will mean that it is a requirement,
while "should" is a suggestion.
1.4 REFERENCES
1.4.1 SOP 0402 Software Quality Assurance Requirements
1.4.2 PRSOO 1 Gamma Camera Product Requirements Specification
1.4.3 HRSOO2 Gamma Camera Hardware Requirements Specification
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company.
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1.5 OVERVIEW
This document is a statement of the requirements for the data
acquisition, processing, interface and diagnostic software of the
2020TC Gamma Camera. The higher level requirements are from the PRSOOl
Gamma Camera Product Requirements Specification and are listed along
with the more detailed software requirements.
2.0 OVERALL DESCRIPTION
2.1 PRODUCT PERSPECTIVE
The 2020TC Gamma Camera is intended for use in the generation of
clinical images in Nuclear Medicine applications. Specifically, the
Camera is intended to image the distribution of radiopharmaceuticals in
the body by means of a collimated photon radiation detector array. In
so doing, the system produces images depicting the anatomical
distribution of the radiopharmaceuticals within the human body for
interpretation by authorized medical personnel.
2.2 USER CHARACTERISTICS
The user of this device will primarily be a nuclear medicine
technologist or nuclear medicine doctor. The user of the diagnostic
modules will be a service technician or engineer.
2.3 CONSTRAINTS
2.3.1 The software shall be written in the higher-level language C. The
source code shall bb written with maintainability as a major priority.
2.4 ASSUMPTIONS AND DEPENDENCIES
The operating system shall be Windows NT.
2.5 APPORTIONING OF REQUIREMENTS
This section is not applicable to these requirements because there are
no requirements that need to be delayed until future versions of the
system.
3.0 DESIGN REQUIREMENTS
These design requirements are based on PRS001 Gamma Camera Product
Requirements Specification.
3.1 DESIGN REQUIREMENT: PRS001 SECTION 2: It is critical that a simple
means of removing the imager head from the Camera system's support arm
be provided and that a simple means of registering, positioning,
attaching, and locking the imaging head to a SPECT gantry assembly be
provided.
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company.
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3.1.1 SOFTWARE REQUIREMENTS
In the SPECT data acquisition mode, the image processing and control
software will ***
it will also
***
***
***
***
The user should have the choice to ignore ***
and operate the SPECT data acquisition mode by ***
***
***
***
***
SPECT Chair only rotates in clockwise direction.
***
***
3.2 DESIGN REQUIREMENT: PRS001 SECTION 4.: Interface Card: It is desirable
that the computer communicates with the interface card via software
driver.... PRS001 4: It is critical that the imaging head and Camera
system should be capable of a count rate performance of 250,000
counts/sec.
3.2.1 SOFTWARE REQUIREMENTS
Data to and from the camera head is communicated ***
***
***
***
***
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should not be released outside of the company without written permission of the
company.
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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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***
***
***
***
***
***
***. These values currently are set at ***
***
***
Software use of all these flags may suggest refinements in how they are
set and reset. For now it is envisioned that an overrun condition would
cause software to read until the Information contained in this document
is proprietary to DIGIRAD Corporation and should not be released
outside of the company without written permission of the company.
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Information contained in this document is proprietary to DIGIRAD Corporation and
should not be released outside of the company without written permission of the
company.
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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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***
***
***
3.3 DESIGN REQUIREMENT: Not Stated in PRS00l
3.3.1 SOFTWARE REQUIREMENTS
After the DMA transfer, the software will decode the data package and
display the events on screen. Software shall allow the user to mask off
hot pixels and to query the number of events of a particular pixel by
simply click at its location.
3.4 DESIGN REQUIREMENT: Not Stated in PRS001
3.4.1 SOFTWARE REQUIREMENTS
The count data in host memory is in raw energy units and shall be
converted to energy units of keV. This conversion shall be performed
using a file containing gain and offset coefficients for each detector
element. Energy corrections shall be applied to each event before the
event is subject to an energy window test.
3.5 DESIGN REQUIREMENT: Not Stated in PRS00l
3.5.1 SOFTWARE REQUIREMENTS
Up to four energy windows shall be available to the user. The upper and
lower energy limits of these windows shall be selectable by the user.
Events falling within the bounds of each of these windows shall be used
to build a scalar file. These four scalar files may be combined in any
fashion to produce three different image files.
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should not be released outside of the company without written permission of the
company.
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*** Portions of this page have been omitted pursuant to a request for
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3.6 DESIGN REQUIREMENT: Not Stated in PRS00l
3.6.1 SOFTWARE REQUIREMENTS
The image files shall be configured as 64 x 64-element arrays.
3.7 DESIGN REQUIREMENT: Not Stated in PRS00l
3.7.1 SOFTWARE REQUIREMENTS
A bad detector element correction shall be applied every time an image
is framed. This shall include persistence mode images. The bad detector
element correction shall be accomplished by deleting from the image
files data from those detector elements listed in the Bad Detector
Element file. The missing data for the bad detector elements shall be
derived by computing the mean value of the data from all the detector
elements surrounding the bad detector element, then assigning that mean
value as the bad detector element's value.
3.8 DESIGN REQUIREMENT: Not Stated in PRS001
3.8.1 SOFTWARE REQUIREMENTS
An intrinsic sensitivity correction shall be applied every time an
image is framed. This shall include persistence mode images. The
intrinsic sensitivity correction shall be accomplished by multiplying
the event data of each uncorrected active detector element by that
detector element's intrinsic sensitivity correction coefficient stored
in a file.
3.9 DESIGN REQUIREMENT: PRS001 SECTION 6.: IT IS CRITICAL THAT THE SYSTEM
SOFTWARE performs four basic functions. These functions are
Acquisition, Display, Data Transfer/Storage and Diagnostics. SECTION 6
A. The Diagnostic module will acquire data and correct energy scale.
3.9.1 SOFTWARE REQUIREMENTS
The Energy Correction module shall generate a gain and offset
coefficient that can be used for conversion into units of keV - each
detector element's raw digitized energy value. These coefficients shall
be stored in a file. Energy correction shall be done by collecting data
from flood field data sets of two isotopes of different energies
probably 201Tl and 99mTc). A peak search algorithm shall find the
primary peaks of these two isotopes for every pixel and a gain and
offset coefficient for each pixel shall be calculated and stored in an
energy correction file.
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should not be released outside of the company without written permission of the
company.
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3.10. DESIGN REQUIREMENT: PRS001 SECTION 6. It is critical that the system
software performs four basic functions. These functions are
Acquisition, Display, Data Transfer/Storage and Diagnostics. SECTION 6
B. The Diagnostic module will acquire data and generate a flood
normalization.
3.10.1 SOFTWARE REQUIREMENTS
Redundant to 3.4!
3.11 DESIGN REQUIREMENT: PRS001 SECTION 6. It is critical that the system
software performs four basic functions. These functions are
Acquisition, Display, Data Transfer/Storage and Diagnostics. SECTION 6
C. The Diagnostic module will acquire data and perform intrinsic
correction.
3.11.1 SOFTWARE REQUIREMENTS
The Intrinsic Correction module shall generate a file of coefficients
that shall be used to normalize each active detector element's response
to a user specified radiopharmaceutical. There shall be a minimum of
four user-defined files. Using the selected radiopharmaceutical in a
uniform flood source, each file shall be generated by collecting an
uncorrected data file. The individual detector element's coefficient
shall be generated by computing the ratio of each active detector
element's response, to the mean value of all the active detector
element's responses.
3.12 DESIGN REQUIREMENT: Not Stated in PRS00l
3.12.1 SOFTWARE REQUIREMENTS
The Detector Element Energy Spectrum module shall acquire and display
an energy spectrum for any selected detector element(s), including bad
detector elements. A detector element may be selected by: 1) pointing
at the detector element on the display with the mouse pointer, 2)
entering the detector element's spatial location as ari XIY spatial
coordinate or by 3) entering the detector element's digital address.
The energy spectrum display shall automatically scale the Y-axis
(counts) so as to place the photopeak height at 75% of full scale. The
X-axis shall be displayed in the energy units of keV. A composite
energy spectrum of all active detector elements shall be possible. An
active detector element is a detector element that is not listed in the
bad detector element file.
3.13 DESIGN REQUIREMENT: Not Stated in PRS001
3.13.1 SOFTWARE REQUIREMENTS
The Bad Detector Element module shall be used with a uniform flood
source to generate a file of detector elements that shall be excluded
from use in the formation of an image.
The following describes the process that shall be used for determining
a "bad detector element". The term "user" equals a technical service
person.
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company.
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Step One
Take a uniform flood data set without any corrections (energy,
uniformity etc.), and record a histogram of energy for each detector
element (i) (there shall be 4096 histograms). Within a user definable
energy window ([W1, Wh]), find the energy peak Ei, and calculate the
FWHM Si for each histogram. Display histograms of the Ei, and Si
distributions. Make a cut of E1 and Si with a set of user definable
windows ([E1, Eh], [Si, Sh]).
{If (Ei [E1, or Ei] Eh, or S1 [Si1 or Si] Sh,) then, (detector element
"i" is added to bad detector element list)}.
Step Two
Take a flood data set, and record an energy corrected histogram for
each detector element. Within a user definable energy window ([W1,
Wh]), calculate the gamma ray count Ni. Display a histogram of the Ni
distribution, and calculated the MEAN and RMS of this distribution.
Make cut of Ni with a set of user given window ([Ni, Nh]).
{If (Ni [N1, or Ni ]Nh) then (detector element "i" is added to bad
detector element list*)}
* Exclude bad detector elements already in the list from the Step One
selection.
Step Three
Take a uniform flood data set with all the corrections, and let the
user point and select any detector element from the displayed flood
image. Display an energy histogram of the selected detector element. If
the user desires, he can add this detector element to the bad detector
element list. The user can also edit the bad detector element list to
manually add or delete any detector element from the list. There should
be a display option to mark each bad detector element within flood
image. There should be a display to show the bad detector element list
and total number of bad detector elements.
The bad detector elements shall be displayable only from the diagnostic
display. This display shall be accessible only through a password and
shall possibly run as a separate Task under NT. Bad detector elements
shall be selectable either by pointing at them with the mouse, entering
their XIY spatial coordinates or by entering their digital address.
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EXHIBIT C
DELIVERY SCHEDULE
DELIVERIES
Calibration and Diagnostic Modules: June 30, 1999
Validation Test Report: 21 days after calibration code
Code Revisions: 21 days after test
PAYMENT
Upon signing this Agreement, a sum of $***.
Upon delivery of the Acquisition Modules, a sum of $***.
Upon delivery of the Calibration & Diag. Modules, a sum of $***.
Upon delivery of the Validation Test Report, a sum of $***.
Upon Digirad's acceptance of all final code revisions, a sum of $***.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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EXHIBIT D
SEGAMI'S BASE SOFTWARE
PLANAR IMAGING:
Acquisition [not including PCI interface board and software]
User entry of patient information - name, MR #, age , etc. (see
database)
Multiple static images
Dynamic mode suitable for "flow studies" including first-pass RNV
Gated (ECG) blood pool
Byte & word mode in 64 x 64 to 512 x 512 pixels per frame
On screen zoomed persistence display - adjustable refresh time
Display previous images on screen while a new image is being acquired
Histogram of R-R wave intervals, beat rejection for gated RNV
Simultaneous acquisition of one study while processing a second study
Adjustment of display parameters - gray scale & color translation
tables
Multi-peak, multi-isotope imaging
Uniformity (flood field) analysis & correction
2. Processing
Renal function: Renogram curves, ERPF, & GFR
Pulmonary quantitation
LVEF & RVEF calculation - gated blood pool
Regional ventricular function, e.g., phase & amplitude analysis
Gastric emptying & esophageal reflux
First-pass RNV - calculation of LV & RV ejection fraction
First-pass cardiac shunt calculation
Frames - move, copy, delete, format (for printing)
Perform math functions on image frames, e.g., spatial & temporal
filters
3. Qutput/Archive/Other
A. File transfer via Ethernet link to network server in DICOM 3
compliant format
Additional bit-mapped (BMP) file format, for file transfer
Printer output drivers to common printers including PostScript
Storage on standard recording media, e.g., hard disk, R-CDROM, etc.
On-line, context sensitive help - index with references to specific
instructions
Complete set of manuals
Documentation of governmental &/or other regulatory approval, U.S. or
foreign
4. Database
SQL compatible Access database storage of patient information
Search features
DICOM 3 compliant fields
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AMENDMENT TO THE DIGIRAD-SEGAMI SOFTWARE LICENSE AGREEMENT
This Amendment to the Digirad-Segami Software License Agreement
("Addendum"), is entered into under seal this 15TH day of NOV, 2001, by and
between ") by and between Segami Corporation, a Maryland corporation having its
principal offices at Segami Corporation 8335 Guilford Rd., Suite I, Columbia MD
21046 ("Segami"), and Digirad Corporation ("Digirad"), a Delaware corporation
having its principal offices at 9350 Trade Place, San Diego, CA 92126.
Background
A. Digirad and Segami entered into a written contract on JUNE 16, 1999
(the "Agreement").
B. The Parties wish to amend the terms of the Agreement pursuant to
paragraph 15 of the Agreement.
C. Digirad is licensing from Segami a modified version of Segami's
Acquisition software, and Segami's current processing and display
software, both known under the trade name Mirage.
D. Digirad desires to develop its own applications, related to
acquisition or processing tasks, to run on the Mirage platform.
In consideration of the mutual promises and covenants herein contained, the
receipt and sufficiency of which are hereby acknowledged, the parties agree
under seal as follows:
1. DEFINITION:
"Digirad Application": an application specified and developed by Digirad's
engineers, with or without help from Segami, using the Mirage development
platform, without modifying existing Mirage applications.
2. DELIVERABLES:
Segami shall deliver its standard version 5 development kit to Digirad,
i.e. all .dll and .lib library files, with all associated .hpp headers,
some sample source code, plus the current documentation on the platform and
its libraries, as is. There will be no support for Mirage version 4.
3. FEES.
For the duration of the current Agreement, Segami grants Digirad a
non-exclusive license to the Mirage development environment, at no
additional charge.
A one-week training session for 2 or 3 Digirad engineers in Segami's
facilities will be offered at no charge (travel, lodging and meal expenses
will be the responsibility of Digirad).
Segami's services to help Digirad develop its own applications are
available to Digirad as part of the technical assistance covered under the
current Agreement, at the same hourly rate, and without increasing the
total guaranteed number of hours.
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4. RESPONSIBILITY.
Segami shall assume no responsibility whatsoever for the applications
developed by Digirad. Segami makes no guarantee that applications developed
by Digirad using the version 5 development platform will work as intended
with any other version of Mirage, or any other similar Segami product.
5. OWNERSHIP RIGHTS.
Segami shall retain all right title and interest in the libraries,
including changes that Segami may make to the libraries at Digirad's
request, and in the Mirage product in its entirety.
Digirad shall have all right, title and interest, in the applications that
it develops.
6. INCORPORATION BY REFERENCE.
This Addendum shall be governed and interpreted as part of the Agreement
and its general terms and conditions. If any conflict exists, or is
determined by a court or arbitrator to exist, between the Agreement and
this Addendum, the Agreement shall be controlling.
In witness whereof, the Parties have caused this Addendum to be executed under
seal as of the date first above written.
ATTEST Segami Corporation
/s/ ILLEGIBLE By: /s/ PHILIPPE BRIANDET
-------------------------------- -----------------------------
Secretary Philippe Briandet, President
Digirad Corporation
--------------------------------
Secretary
By: /s/ ILLEGIBLE
-----------------------------