Exhibit 10.19(a)
LIMITED EXCLUSIVE
PATENT AND COPYRIGHT LICENSE AGREEMENT
FOR
PEREGRINE(TM) DOSE CALCULATION SYSTEM
FOR RADIATION TREATMENT PLANNING
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
NOMOS CORPORATION
LLNL CASE NO. TL-1613-99
▇▇▇▇▇▇▇▇ LIVERMORE NATIONAL LABORATORY
UNIVERSITY OF CALIFORNIA
▇.▇. ▇▇▇ ▇▇▇, ▇-▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
INDUSTRIAL PARTNERSHIPS AND COMMERCIALIZATION
JULY 1999
Exhibit 10.19(a)
TABLE OF CONTENTS
1. BACKGROUND.............................................................................................. 1
2. DEFINITIONS............................................................................................. 3
3. LICENSE GRANT........................................................................................... 7
4. SUBLICENSING RIGHTS AND OBLIGATIONS..................................................................... 8
5. FEES, ROYALTIES AND PAYMENTS............................................................................ 9
6. PERFORMANCE OBLIGATIONS................................................................................ 10
7. PROGRESS AND ROYALTY REPORTS........................................................................... 11
8. BOOKS AND RECORDS...................................................................................... 16
9. TERM................................................................................................... 17
10. TERMINATION AND DISPOSITION OF LICENSED PRODUCTS....................................................... 17
11. PATENT PROSECUTION AND MAINTENANCE..................................................................... 19
12. PATENT AND COPYRIGHT INFRINGEMENT...................................................................... 20
13. USE OF NAMES AND TRADEMARKS............................................................................ 22
14. LIMITED WARRANTY....................................................................................... 22
15. INDEMNIFICATION........................................................................................ 24
16. INSURANCE.............................................................................................. 24
17. WAIVER................................................................................................. 26
18. ASSIGNABILITY.......................................................................................... 27
19. LATE PAYMENTS.......................................................................................... 27
20. NOTICES................................................................................................ 27
21. DISPUTES AND GOVERNING LAWS............................................................................ 28
22. PATENT MARKING......................................................................................... 28
23. COPYRIGHT MARKING...................................................................................... 29
24. GOVERNMENT APPROVAL OR REGISTRATION.................................................................... 30
25. EXPORT CONTROL LAWS.................................................................................... 30
26. FORCE MAJEURE.......................................................................................... 31
27. UNITED STATES PREFERENCE................................................................................ 31
28. PROPRIETARY INFORMATION............................................................................... 31
29. MISCELLANEOUS......................................................................................... 32
EXHIBIT A - LICENSED PATENTS AND LICENSED COPYRIGHTS........................................................ 34
EXHIBIT B - RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS...................................................... 41
EXHIBIT C - FEES AND ROYALTIES.............................................................................. 46
EXHIBIT D - MUTUAL NONDISCLOSURE AGREEMENT.................................................................. 50
LIMITED EXCLUSIVE PATENT AND COPYRIGHT LICENSE AGREEMENT
FOR PEREGRINE(TM) DOSE CALCULATION SYSTEM
FOR RADIATION TREATMENT PLANNING
This Agreement is effective on the Effective Date by and between The Regents of
the University of California ("THE REGENTS"), under its U.S. Department of
Energy Contract No. W-7405-ENG-48 to manage and operate ▇▇▇▇▇▇▇▇ Livermore
National Laboratory ("LLNL"), and NOMOS Corporation, a Delaware corporation
having its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇▇. THE REGENTS is a corporation organized and existing under the laws of the
State of California, with its principal office at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇. THE REGENTS and NOMOS Corporation are referred to
jointly as "Parties."
1. BACKGROUND
1.1 Certain inventions characterized as the PEREGRINE(TM) Dose
Calculation System ("Inventions") and certain copyrightable
works characterized as the computer program PEREGRINE(TM)
version 1.1 ("Software"), described in LLNL patents, patent
applications and copyrights listed in Exhibit A (LICENSED
PATENTS AND LICENSED COPYRIGHTS), which may be useful for
various radiation therapy applications, were made at LLNL and
are covered by THE REGENTS' Patent Rights and THE REGENTS'
Copyright Rights as defined in Article 2 (DEFINITIONS).
1.2 LLNL published a Commerce Business Daily announcement in which
it sought one or more industrial partners to commercialize the
PEREGRINE(TM) Dose Calculation System as a means of achieving
LLNL's objective of ubiquitous, rapid distribution of
PEREGRINE(TM) to radiation therapy clinics. NOMOS Corporation
responded to LLNL's
1
announcement and shares LLNL's objective in commercializing
the PEREGRINE(TM) Dose Calculation System. NOMOS Corporation
Radiation Treatment Planning
1.3 NOMOS Corporation entered into a Mutual Nondisclosure
Agreement provided in Exhibit D (MUTUAL NONDISCLOSURE
AGREEMENT), which is incorporated herein, that allowed it to
evaluate its interest in taking a license to the Inventions
and Software.
1.4 NOMOS Corporation is interested in acquiring certain rights to
the Inventions and Software for the development, manufacture,
and sale of products and services based on the Inventions and
Software. In addition to selling directly to its customers,
NOMOS Corporation is willing to sell such products on an OEM
basis or to sublicense Inventions and Software to other
companies, including NOMOS Corporation's competitors, to
facilitate ubiquitous, rapid distribution of the PEREGRINE(TM)
Dose Calculation System.
1.5 THE REGENTS is willing to grant such rights so that the
Inventions and Software may be developed and used to the
fullest extent for the benefit of the Unites States' economy
and the general public.
1.6 NOMOS Corporation recognizes that royalties due under this
Agreement will be paid on licensed patent applications, issued
patents, and copyrights.
1.7. The Parties have entered into a Work for Others agreement to
facilitate transfer of the PEREGRINE(TM) Dose Calculation
System to NOMOS
2
Corporation for commercial development and to further develop
the Inventions and Software.
1.8 NOMOS Corporation is a "small entity" as defined in 37
CFRss.1.9.
1.9 NOMOS Corporation is a "small business firm" as defined at
section 2 of Pub. L. 85-536 (15 U.S.C.ss.632).
THEREFORE, the Parties agree as follows:
2. DEFINITIONS
2.1 "Effective Date" means the date of execution by the last
signing Party.
2.2 "Field of Use" is the application or use defined in Exhibit B
(RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS).
2.3 "Government" means the United States Government.
2.4 "Lease Price" means gross income from a contract by which
LICENSEE or its sublicensees conveys Licensed Products for a
specified term at a specified fee.
2.5 "Licensed Methods" are any methods, procedures, processes, or
other subject matter whose use or practice would constitute an
infringement of THE REGENTS' Patent Rights but for the license
granted to LICENSEE under this Agreement.
2.6 "Licensed Patents" are:
3
2.6.1 U.S. patents and U.S. patent applications specified
in Exhibit A (LICENSED PATENTS AND LICENSED
COPYRIGHTS), and U.S. patents resulting from these
applications and continuations of these applications,
including divisionals resulting from these
applications, but not including continuation-in-part
applications resulting from these applications;
2.6.2 reissues of 2.6.1;
2.6.3 foreign patent applications filed under Article 11
(PATENT PROSECUTION AND MAINTENANCE) and patents
resulting from these applications; and,
2.6.4 Licensable WFO Subject Inventions.
2.7 "Licensed Products" are products that 1) incorporate or are
produced by the practice of subject matter claimed in Licensed
Patents, and whose manufacture, use, sale, import, or offer
for sale would constitute an infringement of THE REGENTS'
Patent Rights, or 2) duplicate, display, perform, or are
Derivative Works of the subject matter of Licensed Copyrights
and whose duplication, distribution, display, or performance
would constitute an infringement of Licensed Copyrights, but
for the license granted to LICENSEE under this Agreement.
2.8 "LICENSEE" means NOMOS Corporation.
2.9 "Net Sales," as used in this Agreement to compute royalties,
means the aggregate Sale Price, Lease Price, and Service Price
of Licensed Products and Licensed Methods by LICENSEE and any
sublicensees in transactions throughout the world with
independent third parties for cash, or other
4
consideration as mutually agreed by the Parties, using
generally accepted accounting principles.
No deductions will be made from Net Sales for commissions paid
to individuals whether they are with independent sales
agencies or regularly employed by LICENSEE and on its payroll,
or for cost of collections.
2.10 "Sale Price" means the gross invoice selling price after
deducting:
2.10.1 Discounts allowed in amounts customary in the trade;
2.10.2 Sales, tariff duties or use taxes directly imposed
and with reference to particular sales;
2.10.3 Allowances actually paid and limited to rejections,
returns, and prompt payment and volume discounts
granted to customers of Licensed Products, whether in
cash or Licensed Products in lieu of cash;
2.10.4 Freight, transport packing, insurance charges
associated with transportation; and
2.10.5 Taxes, tariff, or import/export duties based on sales
when included in gross sales, but not value-added
taxes or taxes assessed on income derived from such
sales.
The Sale Price of Licensed Products and Licensed Methods that
are disposed of other than by sale or lease is LICENSEE'S
gross invoice selling price for products of similar kind and
quality, sold in similar quantities provided that the Sale
Price shall not be less than the minimum value
5
established in section C.2 of Exhibit C (FEES AND ROYALTIES).
If LICENSEE is not currently offering comparable products for
sale, then the Sale Price is the average gross invoice selling
price at which products of similar kind and quality, sold in
similar quantities, are currently offered for sale by other
manufacturers. If comparable products are not currently sold
or offered for sale by others, then the Sale Price will be
LICENSEE'S cost of manufacture, determined by LICENSEE'S
customary accounting procedures, plus LICENSEE'S standard
markup.
2.11 "Sales of Licensed Products" means sale or lease of Licensed
Products or performance of services using Licensed Products,
Licensed Methods or Licensed Copyrights.
2.12 "Service Price" means gross income from services performed by
LICENSEE or its sublicensees using Licensed Products, Licensed
Methods, or Licensed Copyrights, including gross income for
support, maintenance, and repair services.
2.13 "THE REGENTS' Patent Rights" are THE REGENTS' rights in
Licensed Patents under applicable patent laws.
2.14 "THE REGENTS' Copyright Rights" means THE REGENTS' rights in
Licensed Copyrights under applicable copyright laws.
2.15 "Licensed Copyrights" means the copyrighted works listed in
Exhibit A (LICENSED PATENTS AND LICENSED COPYRIGHTS) and
Licensable WFO Computer Software.
2.16 "Derivative Work" means a work that is based on one or more
pre-existing works and that, if reproduced, distributed to the
public, or displayed
6
publicly or performed publicly without permission of the owner
of the pre-existing work, would constitute copyright
infringement.
2.17 "Licensable WFO Subject Inventions" means Contractor's Subject
Inventions arising from the WFO to which rights have been
waived to THE REGENTS by DOE for licensing in accordance with
THE REGENTS' Contract No. W-7405-ENG-48 with DOE.
2.18 "WFO" means Work for Others Agreement No. L-8788 by and
between the Parties.
2.19 Licensable WFO Computer Software" means Contractor's Computer
Software arising from the WFO in which the Contractor has been
given permission to assert copyright in accordance with its
prime contract with DOE.
2.20 "Use Sublicense" means any agreement by LICENSEE or a
sublicensee which grants to end users, only the right to use,
on a single computer or compute server, object code versions
of Licensed Products.
3. LICENSE GRANT
3.1 The license rights granted to LICENSEE by THE REGENTS are set
forth in Exhibit B (RIGHTS GRANTED AND PERFORMANCE
OBLIGATIONS).
3.2 The Government retains a paid-up, royalty-free,
nontransferable, worldwide, irrevocable license to practice
Licensed Patents by or on behalf of the Government. The
Government has certain other rights under 35
U.S.C.ss.ss.200-212 and applicable regulations.
7
3.3 The Government retains for itself and others acting on its
behalf a paid-up, royalty-free, worldwide, irrevocable license
in Licensed Copyrights to reproduce, prepare Derivative Works,
and perform publicly and display publicly. Beginning ten (10)
years after January 14, 1999, subject to possible five-year
renewals, the Government is granted for itself and others
acting on its behalf a paid-up, nonexclusive, irrevocable
worldwide license in Licensed Copyrights to reproduce,
prepares, distribute copies to the public, perform publicly
and display publicly, and to permit others to do so.
3.4 THE REGENTS reserves all rights not otherwise granted in this
Agreement and the right to use THE REGENTS' Patent Rights and
THE REGENTS' Copyright Rights for educational and research
purposes.
4. SUBLICENSING RIGHTS AND OBLIGATIONS
4.1 The sublicensing rights granted to LICENSEE by THE REGENTS are
set forth in Exhibit B (RIGHTS GRANTED AND PERFORMANCE
OBLIGATIONS), Paragraph B.2.
4.2 LICENSEE will provide THE REGENTS with an executed copy of
each sublicense within thirty (30) days of execution of the
agreement.
4.3. LICENSEE must include in any sublicense all the rights and
obligations due THE REGENTS and the Government set forth in
this Agreement.
4.4 LICENSEE will promptly forward to THE REGENTS any reports and
statements it receives from sublicensees under Article 4.3.
8
4.5 LICENSEE must include in all sublicenses the notice that upon
termination of this Agreement for any reason, THE REGENTS will
automatically succeed to all rights of LICENSEE arising from
sublicenses granted under this Agreement.
5. FEES, ROYALTIES AND PAYMENTS
5.1 As partial consideration for rights granted to LICENSEE,
LICENSEE will pay to THE REGENTS a license issue fee and
maintenance fees as set forth in Exhibit C (FEES AND
ROYALTIES).
5.2 As further consideration for rights granted to LICENSEE,
LICENSEE will pay to THE REGENTS a minimum annual royalty and
an earned royalty based on Net Sales as set forth in Exhibit C
(FEES AND ROYALTIES).
5.3 LICENSEE will pay royalties to THE REGENTS according to the
schedule specified in Article 7 (PROGRESS AND ROYALTY
REPORTS).
5.4 LICENSEE will pay all fees and royalties in U.S. dollars
collectible at par in San Francisco, California. When Licensed
Products are sold for currencies other than U.S. dollars,
earned royalties will first be determined in the foreign
currency of the country in which the Licensed Products were
sold and then converted into equivalent U.S. dollars. The
exchange rate is that rate quoted in the Wall Street Journal
on the last business day of the reporting period and is quoted
as local currency per U.S. dollar. LICENSEE will be
responsible for all bank transfer charges.
5.5 Notwithstanding the provisions of Article 26 (FORCE MAJEURE),
if at any time legal restrictions would prevent LICENSEE from
making payment of part or all of any royalties in any country
outside the U.S.
9
from LICENSEE'S source of funds outside the U.S., LICENSEE
will convert the amount owed to THE REGENTS into U.S. funds
and pay THE REGENTS directly from LICENSEE'S U.S. source of
funds.
5.6 No royalties are due on Net Sales to the Government. LICENSEE
will reduce the amount charged for such sales by an amount
equal to the royalty otherwise due THE REGENTS.
6. PERFORMANCE OBLIGATIONS
6.1 LICENSEE, upon execution of this Agreement, will diligently
proceed with development, regulatory approvals, manufacture,
and sale of Licensed Products and use of Licensed Methods, and
earnestly and diligently endeavor to market the same as
specified in Exhibit B (RIGHTS GRANTED AND PERFORMANCE
OBLIGATIONS).
6.2 During the term of this Agreement, LICENSEE will demonstrate a
continuing effort to commercialize and sell Licensed Products
and use Licensed Methods to meet market demand.
6.3 If LICENSEE does not meet the performance obligations
specified in Exhibit B (RIGHTS GRANTED AND PERFORMANCE
OBLIGATIONS), THE REGENTS may at its sole option: (a) convert
the limited exclusive license for Licensed Patents and
Licensed Copyrights to a nonexclusive license; (b) negotiate
with LICENSEE a new schedule and conditions for continuation
of a limited exclusive license; or (c) terminate this
Agreement.
6.4 THE REGENTS will notify LICENSEE if THE REGENTS is approached
by a third party seeking a license to make, use, or sell
Licensed Products in LICENSEE'S Field of Use. LICENSEE will
negotiate in good faith with that third party to grant a
sublicense for any Licensed Patents or Licensed
10
Copyrights in the market for which LICENSEE and existing
sublicensees are not meeting commercial demand. The
determination to grant a sublicense may be based on LICENSEE'S
business interests. LICENSEE will provide THE REGENTS with
justification for denying any such sublicense.
6.5 During the term of this Agreement, LICENSEE will conduct
normal, continuous business operations. If LICENSEE seeks
protection under any United States bankruptcy proceedings
during the term of this Agreement, LICENSEE will notify THE
REGENTS in writing no later than seventy-two (72) hours after
the bankruptcy filing. THE REGENTS has the option to terminate
this Agreement upon a bankruptcy filing by the LICENSEE.
7. PROGRESS AND ROYALTY REPORTS
7.1 SEMI-ANNUAL PROGRESS REPORT: LICENSEE will submit to THE
REGENTS semiannual progress reports according to the following
schedule:
DUE DATE FOR PREVIOUS PERIOD
-------- -------------------
February 28 July I - December 31
August 31 January 1 - June 30
The progress report must cover LICENSEE'S activities in
meeting the performance obligations set forth in Article 6
(PERFORMANCE OBLIGATIONS) and Exhibit B (RIGHTS GRANTED AND
PERFORMANCE OBLIGATIONS), and must include at a minimum the
following information:
Name of LICENSEE
11
License Number
Date of Report
Reporting period
Summary of work completed
Summary of work in progress
Current schedule of anticipated events or milestones
Description of Licensed Products or Licensed Methods under
development
Licensed Patents and Licensed Copyrights practiced or
incorporated into each Licensed Product and Licensed Method
under development Anticipated market introduction date of
Licensed Products /Methods
Commercial name of Licensed Products /Methods
A summary of resources (dollar value) spent in the reporting
period on commercialization efforts
Name and summary of activities of sublicensees, if any
Changes in corporate ownership (see Article 18, ASSIGNABILITY)
Change in small entity status (see Article 1, BACKGROUND)
12
Addition of and/or participation in an affiliate
Existence of and/or participation in a joint venture
7.2 FIRST COMMERCIAL SALE: Within thirty (30) days following the
first commercial sale of each type of Licensed Product in the
U.S. and each country outside the U.S. by LICENSEE, LICENSEE
will report to THE REGENTS, at a minimum, the following
information:
License Number
Name of LICENSEE
Date of Report
Date of First Commercial Sale or Lease
Place of First Commercial Sale or Lease
Description of Licensed Products/Methods sold or leased
Licensed Patents and Licensed Copyrights practiced or
incorporated
7.3 QUARTERLY WRITTEN ROYALTY REPORTS: After the First Commercial
Sale of Licensed Products or Licensed Methods anywhere in the
world by LICENSEE, LICENSEE will submit quarterly written
royalty reports to THE REGENTS as follows:
DUE DATE FOR PREVIOUS PERIOD
-------- -------------------
February 28 October I - December 31
May 31 January 1 - March 31
August 31 April I - June 30
November 30 July I - September 30
If LICENSEE has not sold or used any Licensed Products or
Licensed Methods during the reporting period, LICENSEE will so
state in the royalty report. The quarterly royalty report must
include at a minimum
13
the following information: License Number Name of
LICENSEE Date of Report Reporting period Report of
sales: For each type of Licensed Products/ Methods:
Name/ description of each type of product or process
A. Domestic sales:
1. Description of Licensed Products /Methods
2. Unit price (sale, lease, and/or use)
3. Units sold in U.S.
4. Units leased in U.S.
5. Gross sales in U.S.
6. Net Sales in U.S.
7. Accrued royalties
8. If Government approval requirements apply to
sale/use of the Licensed Product/Method (see Article
24, GOVERNMENT APPROVAL OR REGISTRATION), provide
details.
B. Foreign sales:
1. Country of sales
2. Description of Licensed Products /Methods
3. Unit price (sale, lease, and/or use)
4. Units sold in each country
5. Units leased in each country
6. Gross sales in each country
7. Net Sales in each country
8. Monetary exchange rate
9. Accrued royalties in $U.S.
10. If foreign government approval/ registration
requirements apply to sale/use of the Licensed
Product/Method (see Article 24, GOVERNMENT APPROVAL
OR REGISTRATION), provide details.
14
C. Government Sales:
1. Description of Licensed Products /Methods
2. Unit price (sale, lease, and/or use)
3. Units sold
4. Units leased
5. Gross sales
6. Net Sales to the Government
Provide information A-C for each type of product or process sold
D. Royalties Due THE REGENTS
MINIMUM ROYALTY PAID FOR TOTAL ACCRUED ROYALTIES TO DATE
THIS CALENDAR YEAR FOR THIS CALENDAR YEAR ROYALTIES DUE
------------------------- ------------------------------- -------------
7.4 LICENSEE will provide THE REGENTS with an annual audited
statement of royalty accounts within sixty (60) days after the
end of each calendar year. THE REGENTS will protect such
statements as Proprietary Information and not disseminate them
unless required by law.
7.5 LICENSEE will report in writing to THE REGENTS, within ten
(10) days of their occurrence, dates of the following events
pertaining to performance obligations specified in Exhibit B
(RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS):
7.5.1 LICENSEE'S filings of relevant regulatory
applications pertaining to Licensed Products in
accordance with B.5.1.
7.5.2 Each grant of clearance by the FDA for Licensed
Products.
15
7.5.3 LICENSEE'S compliance with performance obligations
specified in B.5.2, B.5.4, B.5.5, B.5.6, and B.5.7.
8. BOOKS AND RECORDS
8.1 LICENSEE will keep books and records accurately showing the
manufacture, use, sale, and lease of Licensed Products,
Licensed Methods and Licensed Copyrights, and Sales of
Licensed Products under this Agreement. LICENSEE will preserve
such books and records for at least five (5) years after the
date of the royalty payment to which they apply. Such books
and records will be open for inspection by representatives or
agents of THE REGENTS at all reasonable times, with reasonable
notice given.
8.2 THE REGENTS will pay the costs incurred by its representatives
or agents to examine LICENSEE's books and records. If there is
an error adverse to THE REGENTS in LICENSEE'S royalty
accounting, then LICENSEE will pay THE REGENTS within ten (10)
days the amount necessary to correct such error. If there is
an error adverse to THE REGENTS in LICENSEE'S royalty
accounting of more than ten percent (10%) of the total
royalties due for any year, then LICENSEE will pay the costs
incurred by THE REGENTS' representatives and agents for such
examination.
8.3 LICENSEE will provide THE REGENTS with an annual audited
financial statement of LICENSEE, including at a minimum a
balance sheet and operating statement or LICENSEE'S annual
report. Such statement will be due to THE REGENTS within one
hundred twenty (120) days following the close of LICENSEE'S
fiscal year to which such statement relates.
9. TERM
16
9.1 The term of this Agreement is the longer of either the term of
the license to Licensed Patents or the term of the license to
Licensed Copyrights.
9.2 The term of the license to Licensed Patents will commence on
the Effective Date and, unless terminated by operation of law
or by acts of the Parties under this Agreement, will remain in
effect until the expiration or abandonment of all Licensed
Patents.
9.3 The term of the license to Licensed Copyrights will commence
on the Effective Date and, unless terminated by operation of
law or by acts of the Parties under this Agreement, will
remain in effect for ten (10) years from January 14, 1999, the
date on which THE REGENTS received permission to assert
copyright. The term of the license to Licensed Copyrights may
be renewed for additional five-year periods for the life of
the copyright upon mutual written agreement of the Parties.
10. TERMINATION AND DISPOSITION OF LICENSED PRODUCTS
10.1 If LICENSEE fails to perform any material term or covenant of
this Agreement, THE REGENTS may give written notice to
LICENSEE that if LICENSEE has not cured such failure within
sixty (60) days after the effective date of receipt of the
notice, this Agreement will terminate at the end of such
sixty- (60) day period or at the end of such longer period as
may be set forth in THE REGENTS' notice.
10.2 LICENSEE may terminate this Agreement by giving at least
thirty (30) days prior written notice to THE REGENTS.
17
10.3 Termination of this Agreement will not relieve LICENSEE of any
obligation or liability accrued hereunder prior to such
termination, nor rescind any payments due or paid to THE
REGENTS prior to the time such termination becomes effective.
Such termination will not affect, in any manner, any rights of
THE REGENTS arising under this Agreement prior to such
termination. Any and all obligations of the Parties under this
Agreement will remain in effect until properly fulfilled or
otherwise discharged, notwithstanding the completion or early
termination of this Agreement.
10.4 Within thirty (30) days after termination of this Agreement by
either Party, LICENSEE will provide THE REGENTS with a written
inventory of all Licensed Products in process of manufacture
or in stock on the date of termination. LICENSEE may complete
Licensed Products in the process of manufacture at the time of
termination, and may dispose of Licensed Products for sixty
(60) days after the date of termination provided that LICENSEE
pays royalties to THE REGENTS on such dispositions. At the
conclusion of the sixty (60) day period, LICENSEE will destroy
any remaining Licensed Products in stock or in process of
manufacture and certify such destruction to THE REGENTS.
10.5 LICENSEE may not practice Licensed Patents or use Licensed
Copyrights after the date of termination of this Agreement
except as necessary to complete the manufacture of Licensed
Products as permitted under Article 10.4.
10.6 This Agreement will terminate, effective thirty (30) days
after the Effective date of notice by THE REGENTS, if LICENSEE
ceases to carry on its business.
18
11. PATENT PROSECUTION AND MAINTENANCE
11.1 THE REGENTS will prosecute U.S. patent applications and
maintain U.S. patents licensed under this Agreement at THE
REGENTS' expense, unless otherwise agreed by the Parties.
11.2 LICENSEE may request foreign rights in Licensed Patents, if
such rights are available. Unless requested herein, LICENSEE
must request in writing such rights, and specify the countries
in which it wants rights, within seven (7) months after the
filing date of the U.S. applications. Failure to request such
rights will be considered an election not to seek foreign
rights. THE REGENTS may file patent applications at its own
expense in any country in which LICENSEE has not elected to
secure foreign rights, and LICENSEE has no rights to any such
foreign applications and resultant patents.
11.3 LICENSEE will pay all costs, including those incurred by THE
REGENTS prior to the Effective Date, associated with
preparation, filing, prosecution, and maintenance of Licensed
Patents in foreign countries in which LICENSEE obtains rights
under this Agreement. All Licensed Patents will be held in the
name of THE REGENTS and obtained using counsel selected by THE
REGENTS.
11.4 LICENSEE may terminate its license to foreign patent
applications or patents, and its obligation to pay any further
costs for those foreign rights, upon ninety (90) days written
notice to THE REGENTS. THE REGENTS or the Government may, at
its sole discretion and expense, continue prosecution and/or
maintenance of any patents or applications for which LICENSEE
has relinquished rights.
19
12. PATENT AND COPYRIGHT INFRINGEMENT
12.1 If LICENSEE learns of the possible infringement by a third
party of any Licensed Patents or Licensed Copyrights, LICENSEE
will inform THE REGENTS in writing within thirty (30) days and
provide all known evidence of the infringement. LICENSEE will
not contact such third party concerning the infringement
without prior written approval of THE REGENTS. The Parties
will use their best efforts to terminate such infringement
without litigation.
12.2 LICENSEE may request in writing that THE REGENTS take legal
action against an infringer of any Licensed Patents or
Licensed Copyrights, which request must include reasonable
evidence of the infringement and of potential damages to
LICENSEE. Within one hundred (100) days after the date of
receipt by THE REGENTS of LICENSEE'S request, if the
infringement continues, THE REGENTS will notify LICENSEE in
writing that THE REGENTS will either:
12.2.1 Commence suit on its own account; or
12.2.2 Refuse to participate in such suit. LICENSEE may
thereafter bring suit for infringement at its own
expense if, and only if, THE REGENTS elects not to
commence suit and if the infringement occurred during
the period and in a jurisdiction where LICENSEE has
exclusive rights under this Agreement. However, in
the event LICENSEE elects to bring suit in accordance
with this Article, THE REGENTS may thereafter join
such suit at its own expense. If THE REGENTS elects
to not participate in such suit, LICENSEE may join
THE REGENTS in any suit in which THE REGENTS is a
necessary party for the suit to proceed, and if so
joined the
20
LICENSEE will pay all reasonable costs of THE REGENTS
associated with joining the suit as a necessary party
to the litigation.
12.3 Any legal or equitable action brought under this Article 12
will be at the expense of the Party bringing such legal or
equitable action and all recoveries will belong to such Party.
Legal or equitable action brought jointly by THE REGENTS and
LICENSEE and participated in by both will be at the joint
expense of the Parties in such proportions as are agreed to in
writing, and all recoveries will be shared by them in
proportion to the expense paid by each Party, or otherwise as
they may agree in writing.
12.4 The Parties will cooperate with each other in legal and
equitable proceedings instituted against an infringing third
party, but such cooperation by a Party will be at the expense
of the Party bringing such legal or equitable action; if both
Parties bring the action, the principles of Article 12.3 will
apply. Such legal or equitable action will be controlled by
the Party bringing the legal or equitable action, except that
THE REGENTS may be represented by counsel of its choice in any
action brought by LICENSEE.
13. USE OF NAMES AND TRADEMARKS
Neither Party has any right to use any name, trade name,
trademark, or other designation of the other Party (including
any contraction, abbreviation, or simulation) in advertising,
publicity, or other promotional activities. Unless required by
law, the use of the name "▇▇▇▇▇▇▇▇ Livermore National
Laboratory," or "The Regents of the University of California,"
or the name of any University of California campus by
21
LICENSEE is expressly prohibited under California Education
Code ss.92000.
14. LIMITED WARRANTY
14.1 THE REGENTS has the right to grant the license granted in this
Agreement.
14.2 THIS LICENSE AND THE ASSOCIATED INVENTIONS AND SOFTWARE ARE
PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED.
THE REGENTS AND DOE MAKE NO REPRESENTATION OR WARRANTY THAT
LICENSED PRODUCTS OR LICENSED METHODS WILL NOT INFRINGE ANY
PATENT, COPYRIGHT OR OTHER PROPRIETARY RIGHT.
14.3 IN NO EVENT WILL THE REGENTS OR DOE BE LIABLE FOR ANY
INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES RESULTING FROM
EXERCISE OF THIS LICENSE OR THE USE OF THE SOFTWARE,
INVENTIONS, LICENSED METHODS, OR LICENSED PRODUCTS.
14.4 Nothing in this Agreement will be interpreted as:
14.4.1 A warranty or representation by THE REGENTS as to the
validity or scope of Licensed Patents or Licensed
Copyrights; or
14.4.2 A warranty or representation that anything made,
used, duplicated, displayed, performed, sold, or
otherwise disposed of
22
under the license granted in this Agreement is or
will be free from infringement of intellectual
property rights of third parties; or
14.4.3 Any obligation to bring suit against a third party
for patent or copyright infringement; or
14.4.4 Conferring by implication, estoppel, or otherwise any
license or rights under 1) any patents of THE REGENTS
other than Licensed Patents, regardless of whether
such patents are dominant or subordinate to Licensed
Patents or 2) any copyrights of THE REGENTS other
than Licensed Copyrights as defined in this
Agreement; or
14.4.5 An obligation to furnish to LICENSEE or any third
party any know-how, improvements, or Derivative Works
not specifically provided in this Agreement.
15. INDEMNIFICATION
LICENSEE will, and will require its sublicensees to,
indemnify, hold harmless, and defend THE REGENTS, DOE, their
officers, employees, and agents; the sponsors of the research
that led to the Inventions and Software; and the inventors and
authors against any claims, suits, losses, liabilities,
damages, costs, fees, and expenses resulting from or arising
out of exercise of this license or any sublicense. LICENSEE
will pay any and all costs, including reasonable attorney
fees, incurred by THE REGENTS in enforcing this
indemnification.
16. INSURANCE
23
16.1 LICENSEE will insure its activities relating to this Agreement
at its own cost with an insurance company acceptable to THE
REGENTS. LICENSEE will obtain, keep in force, and maintain
insurance as follows with an insurance company acceptable to
THE REGENTS or an equivalent program of self-insurance:
Comprehensive or Commercial Form General Liability Insurance,
including contractual liability and product liability, with
coverage as follows:
16.1.1 Each occurrence coverage of not less than One Million
Dollars ($1,000,000.00);
16.1.2 Product Liability Insurance: completed operations
aggregate coverage of not less than Ten Million
Dollars ($10,000,000.00);
16.1.3 Personal and Advertising Injury: coverage of not less
than One Million Dollars ($1,000,000.00); and
16.1.4 General Aggregate (Commercial Form Only): coverage of
not less than Five Million Dollars ($5,000,000.00).
These coverages do not limit the liability of LICENSEE to THE
REGENTS in any way. LICENSEE will provide THE REGENTS, upon
request, with certificates of insurance or self-insurance,
including renewals that show compliance with these
requirements. LICENSEE'S failure to maintain such required
insurance will be considered a material breach of this
Agreement.
16.2 If the required insurance is written on a claims-made form,
coverage must provide a retroactive date of placement before
or coinciding with the Effective Date of this Agreement.
24
16.3 LICENSEE will maintain the general liability insurance
specified in this Article16 during the period that the
Licensed Patents or Licensed Copyrights are being used and/or
Licensed Products are being sold or otherwise commercially
distributed by LICENSEE, and for a period of not less than
five (5) years thereafter.
16.4 LICENSEE'S insurance coverage must:
16.4.1 Provide for at least thirty (30) days advance written
notice to THE REGENTS of cancellation or any
modification;
16.4.2 Indicate that DOE, THE REGENTS, and their respective
officers, employees, students, and agents, are
endorsed on the policy as additional named insureds;
and
16.4.3 Include a provision that the coverage is primary and
does not participate with, or is in excess of, any
valid and collectible insurance, program, or
self-insurance carried or maintained by THE REGENTS.
17. WAIVER
17.1 No provision of this Agreement is deemed waived and no breach
excused unless such waiver or consent is made in writing and
signed by the Party to have waived or consented.
17.2 Failure on the part of either Party to exercise or enforce any
right of such Party under this Agreement will not be a waiver
by such Party of any
25
right, or operate to bar the enforcement or exercise of the
right at any time thereafter.
26
18. ASSIGNABILITY
This Agreement is binding on and inures to the benefit of THE
REGENTS, its successors and assigns, but is personal to
LICENSEE. Any assignment or bankruptcy assumption of this
Agreement requires prior written consent of THE REGENTS which
consent shall not be unreasonably withheld.
19. LATE PAYMENTS
If THE REGENTS does not receive payments or fees due from
LICENSEE hereunder when due, LICENSEE must pay such payments
or fees within sixty (60) days plus interest charges at the
rate of ten percent (10%) simple interest per annum from the
date on which the payment was originally due, or THE REGENTS
may terminate this Agreement in accordance with its terms.
20. NOTICES
Any report, payment, notice, or other communication that
either Party receives under this Agreement must be in writing
and will be properly given and effective on the date of
delivery if delivered in person (including delivery by courier
service), or the fifth (5th) day after mailing if mailed by
first-class certified mail, postage paid, to the addresses
given below (or to an address designated by written notice to
the other Party), or the date of facsimile with confirmed
receipt.
27
In the case of LICENSEE: NOMOS Corporation
▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Phone: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: President
In the case of THE REGENTS:
All correspondence, original progress
reports, and royalty reports: ▇▇▇▇▇▇▇▇ Livermore, National Laboratory
Industrial Partnership and
Commercialization
▇.▇. ▇▇▇ ▇▇▇, ▇-▇▇▇
▇▇▇▇ ▇▇▇▇ ▇▇▇., ▇-▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Director, IPAC
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Payments and copies of
corresponding royalty reports: ▇▇▇▇▇▇▇▇ Livermore National Laboratory
▇.▇. ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
21. DISPUTES AND GOVERNING LAWS
The Parties will attempt to jointly and promptly resolve any
disputes arising from this Agreement. If the Parties are
unable to resolve a dispute within a reasonable time from one
Party's written notice to the other that dispute resolution
has begun, then either Party may commence proceedings in a
court of competent jurisdiction. This Agreement will be
governed by the laws of the State of California, U.S.A.,
without regard to such State's conflict of laws provisions.
22. PATENT MARKING
28
LICENSEE will ▇▇▇▇ all Licensed Products and their containers
that are made, used, sold, or otherwise disposed of under this
Agreement in accordance with applicable patent marking laws.
23. COPYRIGHT MARKING
For all Licensed Products that incorporate Licensed
Copyrights, LICENSEE will affix to all copies of such Licensed
Products and their containers that are made, used, or sold or
otherwise distributed under this Agreement:
a) the proper copyright notice in accordance with
applicable copyright marking laws; and
b) the following notice:
"NOTICE: The Government is granted for itself and others
acting on its behalf a paid-up, nonexclusive, irrevocable,
worldwide license in this data to reproduce, prepare
Derivative Works, and perform publicly and display publicly.
Beginning ten (10) years after January 14, 1999, and subject
to any subsequent five (5) year renewals, the Government is
granted for itself and others acting on its behalf a paid-up,
nonexclusive, irrevocable, worldwide license in this data to
reproduce, prepare Derivative Works, distribute copies to the
public, perform publicly and display publicly, and to permit
others to do so. NEITHER THE UNITED STATES NOR THE UNITED
STATES DEPARTMENT OF ENERGY, NOR THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA, NOR ANY OF THEIR EMPLOYEES, MAKES ANY WARRANTY,
EXPRESS OR IMPLIED, OR ASSUMES ANY LEGAL LIABILITY OR
RESPONSIBILITY
29
FOR THE ACCURACY, COMPLETENESS, OR USEFULNESS OF ANY
INFORMATION, APPARATUS, PRODUCT, OR PROCESS DISCLOSED, OR
REPRESENTS THAT ITS USE WOULD NOT INFRINGE PRIVATELY OWNED
RIGHTS."
24. GOVERNMENT APPROVAL OR REGISTRATION
If this Agreement or any associated transaction is required by
the law of any jurisdiction to be approved, permitted, or
registered with any governmental agency, LICENSEE assumes all
obligations to do so. LICENSEE will notify THE REGENTS if
LICENSEE becomes aware that this Agreement is subject to a
United States or foreign government reporting, permitting, or
approval requirement. LICENSEE will make all necessary filings
and pay all costs including fees, penalties, and all other
out-of-pocket costs associated with such reporting,
permitting, or approval process.
25. EXPORT CONTROL LAWS
LICENSEE will comply with all applicable United States and
foreign laws and regulations concerning the transfer of
Licensed Products and related technical data, including but
not limited to International Traffic in Arms Regulations
(ITAR) and Export Administration Regulations.
30
26. FORCE MAJEURE
The Parties will be excused from any performance required
hereunder if such performance is rendered impossible or
unfeasible due to any Acts of God, catastrophes, or other
major events beyond their reasonable control, including,
without limitation, war, riot, and insurrection; laws,
proclamations, edicts, ordinances, or regulations; strikes,
lock-outs, or other serious labor disputes; and floods, fires,
explosions, or other natural disasters. However, either Party
will have the right to terminate this Agreement pursuant to
this Article upon sixty (60) days prior written notice if
either Party is unable to fulfill its obligations under this
Agreement due to any of the causes mentioned above and such
inability continues for a period of one (1) year.
27. UNITED STATES PREFERENCE
LICENSEE agrees that any Licensed Products and Licensed
Methods for applications, use, or sale shall be manufactured
substantially in the United States.
28. PROPRIETARY INFORMATION
The term of the Mutual Nondisclosure Agreement (MNDA) between
the Parties, attached as Exhibit D (MUTUAL NONDISCLOSURE
AGREEMENT), is hereby extended for the term of this Agreement.
The confidentiality obligation of the MNDA will also apply to
any other Proprietary Information provided in connection with
this Agreement that is clearly marked in accordance with the
MNDA, such as patent prosecution, engineering drawings,
process and technical information,
31
and other related information not contemplated when the MNDA
was executed.
29. MISCELLANEOUS
29.1 The headings of the Articles of this Agreement are for
reference only and do not affect the interpretation of this
Agreement.
29.2 Any amendment or modification of this Agreement must be in
writing and signed by each Party.
29.3 This Agreement, with the attached Exhibits A, B, C, and D,
embodies the entire understanding of the Parties with respect
to the subject matter of this Agreement, and supersedes all
other communications, representations, or understandings,
either oral or written, between the Parties with respect to
such subject matter.
29.4 If any provision of this Agreement is held to be invalid,
illegal, or unenforceable in any respect, such provision will
be enforced to the extent legally permissible and such
invalidity, illegality, or unenforceability will not affect
any other provisions of the Agreement, and this Agreement will
be construed as if the invalid, illegal, or unenforceable
provision, or relevant portion, were never in this Agreement.
29.5 Neither Party is an agent of the other and neither will have
any power to contract for or bind the other Party for any
purpose.
THE REGENTS and LICENSEE hereby execute this Agreement, in duplicate originals,
by their respective duly authorized officers.
32
NOMOS CORPORATION THE REGENTS OF THE
UNIVERSITY OF CALIFORNIA
▇▇▇▇▇▇▇▇ LIVERMORE
NATIONAL LABORATORY
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇ By: /s/ ▇. ▇▇▇▇▇▇▇▇▇
---------------------------------------- ------------------------------------------
(Signature) (Signature)
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
---------------------------------------- ------------------------------------------
Title: President & CEO Title: Deputy Director for Science and Technology
--------------------------------------- ------------------------------------------
Date Signed: 7/20/99 Date Signed: July 19, 1999
33
EXHIBIT A - LICENSED PATENTS AND LICENSED COPYRIGHTS
THE LICENSED PATENTS ARE AS FOLLOWS:
UNITED STATES PATENTS GRANTED:
------------------------------
INVENTION PATENT TITLE INVENTORS FILING ISSUE
DISCLOSURE NUMBER NUMBER DATE DATE
------------------- --------------- -------------------------------- ------------------------ ------------- --------------
IL-9839 5870697 Calculation of Radiation ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, 3/5/96 2/9/99
Therapy Does Using all ▇▇▇▇▇▇▇▇▇ ▇.
Particle Monte Carlo Transport Hartmann-Siantar,
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
UNITED STATES PATENT APPLICATIONS:
----------------------------------
INVENTION PATENT TITLE INVENTORS FILING ISSUE
DISCLOSURE NUMBER NUMBER DATE DATE
------------------- --------------- -------------------------------- ------------------------ ------------- --------------
IL-10165 09/082511 Evaluated Teletherapy Source ▇▇▇▇▇▇▇▇ ▇. ▇▇▇, 5/21/98 5/22/97
Library (ETSL) ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ von
Wittenau
IL-10350 09/23829 System and Method for ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, 1/28/99 11/12/98
1 Radiation Dose Calculation ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇
Within sub-Volumes of a ▇. ▇▇▇▇▇, ▇▇▇▇▇
▇▇▇▇▇ Carlo Based ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇
Particle Transport Grid ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ House,
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇-
Siantar, ▇▇▇▇▇▇▇▇ ▇.
▇▇▇, ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇,
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Von
Wittenau
IL-10351 09/24765 FALCON: Automated Tser-▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ 2/9/99 9/10/98
1 Optimization for Arbitrary ▇. ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇.
34
Criteria Hartmann-Siantar
PROVISIONAL PATENT APPLICATIONS:
--------------------------------
INVENTION PATENT TITLE INVENTORS FILING
DISCLOSURE NUMBER NUMBER DATE
------------------- ---------------- ------------------------------- ------------------------ -------------
IL-10472 60/123242 Correlated Histogram ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ von 3/8/99
Representation of Monte ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Derived Medical Accelerator
Photon-Output Phase Spaces
FOREIGN PATENTS GRANTED: None
-----------------------
FOREIGN PATENT APPLICATIONS:
----------------------------
INVENTION PATENT TITLE INVENTORS FILING
DISCLOSURE NUMBER NUMBER DATE
------------------ ----------------- ------------------------------- ------------------------ -------------
IL-9839 97915859.9-EP Calculation of Radiation ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, 3/5/96
All EP Therapy Dose Using All ▇▇▇▇▇▇▇▇▇ ▇.
Countries Particle Monte Carlo Transport Hartmann-Siantar,
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
IL-9839 531993/1997-JP Calculation of Radiation ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, 2/28/97
Therapy Does Using All ▇▇▇▇▇▇▇▇▇ ▇.
Particle Monte Carlo Transport Hartmann-Siantar,
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
IL-9839 2248862-CA Calculation of Radiation ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, 2/28/97
Therapy Does Using All ▇▇▇▇▇▇▇▇▇ ▇.
Particle Monte Carlo Transport Hartmann-Siantar,
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
FUTURE PATENT RIGHTS
--------------------
35
Licensable WFO Subject Inventions will be added by amendment. THE LICENSED
COPYRIGHTS ARE AS FOLLOWS:
COPYRIGHT ASSERTION
PEREGRINE(TM), Version 1.1
1a. Software Acronym:
PEREGRINE.
1b. Short Title:
3D All Particle Monte Carlo code to calculate radiation dose delivered
to cancer patients.
2. Authors Names and Affiliations:
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇. ▇▇▇, ▇▇▇
▇. ▇▇▇▇, ▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇▇▇▇. ▇. ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇▇ ▇.
House, ▇▇▇ ▇. ▇▇▇▇, ▇▇▇▇ ▇. ▇▇▇▇▇, ▇▇▇▇▇▇ ▇. May, ▇▇▇▇▇▇ ▇. ▇▇▇▇▇,
▇▇▇▇▇. ▇. ▇▇▇▇▇▇, ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ Siantar,
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, ▇▇▇▇▇ 1. ▇▇▇▇▇▇▇,
▇▇▇▇ A White, (LLNL).
3. Software completion Date: July 1999.
4. Brief Description:
PEREGRINE is a 3D All Particle Monte Carlo Code that calculates the
dose to cancer patients from a variety of clinical radiation sources.
PEREGRINE utilizes large nuclear, atomic, and electron databases, the
patient CT scan data, and the Monte Carlo method to accurately
calculate the dose delivered to a patient for photon teletherapy
sources. The results of the dose calculation are then written to a file
for graphical display over the CT scan data.
5. Method of Solution:
PEREGRINE uses conventional analog and condensed history Monte Carlo
radiation transport methods to calculate dose three-dimensional dose
distributions in the body. It reads input from standard treatment
planning exchange files.
6. Computer(s) for which software is written:
UNIX workstation.
36
7. Operating System:
UNIX, Solaris.
8. Programming Language(s) Used:
Fortran (physical transport), C (1/0), Perl (scripting language used to
run PEREGRINE), Tcl/Tk (scripting and control).
9. Software Limitations:
Must run on a UNIX workstation with >128MB RAM/CPU.
10. Unique Features of the Software:
PEREGRINE package includes a PEREGRINE Monte Carlo transport software,
LLNL generated atomic data.
11. Related and Auxiliary Software:
None.
12. Other Programming or Operating Information or Restrictions:
None.
13. Hardware Requirements:
UNIX workstation with >128MB RAM/CPU.
14. Time Requirements:
Time requirements vary substantially with the complexity of the problem
addressed.
Technical Description of Licensed Copyrights
--------------------------------------------
The files are:
libpg - PEREGRINE Monte Carlo library source files:
alias_sampling. F
alias_sampling_choice.F
check.F
direction_cosines.F
dose_mesh_data.F
electron_data.F
electron_physics.F
37
elpo_distribution.h
energy_groups.F
energy_groups.h
epsilon.h
file_io.F
form_factors.F
material_data.F
mesh_data.F
particle_attributes.h
particle_bank.F
particle_bank.h
particle_intercepts.F
pg_F pg_instantiate_device.F
pg_transport.F
photon_data.F
photon_physics.F
place_deposit.F
radial_function.F
random_numbers.F
random_numbers.h
source_data.F
source_electron_physics.F
source_geometry.F
source_particle.F
source_photon_physics.F
source_rejection.F
source_transport.F
timer.F track_particle.F
transform_coordinates.F
transform_coordinates.h
version_pglib.h
libtpi - Treatment Planning Interface source files:
beam_geometry.c
ct_scan.c
dose.c
dose_array.c
f77_Wrapper.c
inst_log_file.c
log_msg.c
runtime_diagnostics.c
38
scanner_data.c
structurex
tpi_support.c
tpi_support.h
version.h
libtsl - Teletherapy Source Library source files:
beam_device_compare.c
crc_checksum.c
device_data.c
f77_wrapper.c
fit_data.c
fit_data.d
instantiate_device.c
modify_one_device.c
pdt_data.c
runtime_option.c
transform_one_device.c
tsl_support.c
tsl_support.h
include - source files:
case_data.h
distributed_data.h
histo.h
material_data.h
pdt_data.h
pg.h
pg_constants.h
pg_exec.h
pg_types. h
physics_constants_h
runtime_options.h
timer.h
tpi.h
tsl.h
tuning_parameters.h
Single-Threaded test executive and utilities source files
Master Slave executive source files
39
FUTURE COPYRIGHT RIGHTS:
------------------------
Licensable WFO Computer Software will be added by amendment.
40
EXHIBIT B - RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS
NOTICE
LICENSEE CONSIDERS INFORMATION IN THIS EXHIBIT B TO BE
PROPRIETARY.
B.1 RIGHTS GRANTED
B.1.1 Rights to Licensed Patents
Subject to the limitations set forth in this Agreement, THE
REGENTS hereby grants to LICENSEE an exclusive,
nontransferable, royalty-bearing license to: a) make, have
made, use, sell, offer for sale, and import Licensed Products
in the Field of Use, and b) practice Licensed Methods in the
Field of Use.
B.1.2 Rights to Licensed Copyrights
Subject to the terms and conditions of this Agreement, THE
REGENTS grants to LICENSEE an exclusive, nontransferable,
royalty-bearing license to duplicate, display, perform, make
Derivative Works, distribute and have distributed, and sell
Licensed Products covered by Licensed Copyrights in the Field
of Use.
B.1.3 "Field of Use" means planning human and animal cancer
therapies based on tumor irradiation with photons or electrons
that are generated either by a radiation source external to
the patient (teletherapy) or by a radiation source internal to
the patient (brachytherapy).
B.2 SUBLICENSING RIGHTS
41
THE REGENTS also grants to LICENSEE the right to issue royalty-bearing
sublicenses to third parties in the Field of Use, having rights no
greater than those granted to LICENSEE, provided that LICENSEE has
exclusive rights inb such Licensed Patents and Licensed Copyrights in
the Field of Use at the time of sublicensing. A Use Sublicense is
considered to be a Licensed Product and not a sublicense as
contemplated in this B.2.
B.3 RIGHTS EXCLUDED
Rights that are not specifically granted in this Exhibit B or
elsewhere in this Agreement are specifically excluded from the
license.
B.4 FUTURE RIGHTS
Licensable WFO Subject Inventions and Licensable WFO Computer Software
will be added to Exhibit A by amendment.
B.5 PERFORMANCE OBLIGATIONS
B.5.1 LICENSEE will proceed diligently to develop, file relevant
regulatory applications for and attempt to obtain relevant
regulatory commercialization approvals with respect to the
manufacturing, marketing, and sale of Licensed Products for
all uses in the Field of Use. LICENSEE will file with the U.S.
Food and Drug Administration at least one 510k Application or
PMA (Pre-Market Approval) for clearance of Licensed Products
for at least teletherapy uses within one (1) year of the
Effective Date. Notwithstanding any other term of this
Agreement, for the purposes of (a) invoking/ complying with
the ▇▇▇▇▇-▇▇▇▇▇▇ Act (35 U.S.C.ss.156) and any corresponding
rules and regulations of the U.S.
42
Patent & Trademark Office regarding patent term extension, and
(b) seeking regulatory approval of LICENSEE'S Licensed
Products and Licensed Methods, LICENSEE shall act as THE
REGENTS' agent. To the extent deemed necessary by LICENSEE, in
good faith, the Parties will cooperate to secure regulatory
approval of LICENSEE'S Licensed Products and Licensed Methods.
B.5.2 LICENSEE will release for distribution and offer Sales of
Licensed Products by the later date of either October 1, 2000,
or within sixty (60) days after the date of FDA clearance for
teletherapy uses of Licensed Products.
B.5.3 LICENSEE will have gross revenues from Sales of Licensed
Products or use of Licensed Methods of at least Three Million
Dollars ($3,000,000.00) per calendar year, as measured at the
close of LICENSEE's business on
December 31 of the relevant calendar year, commencing with the
later of calendar year 2001, or the first full calendar year
after a Licensed Product has been released for distribution
and offered for sale in accordance with paragraph B.5.2.
B.5.4 LICENSEE will release for distribution and offer first OEM
sale of Licensed Products that interface with radiation
treatment planning systems that are manufactured and sold, or
otherwise distributed to third parties, by entities other than
LICENSEE by the later date of either
October 1, 2001, or one year after initial release for
distribution and offer of Sales of Licensed Products as
defined in B.5.2. To the extent that some commercial entities
may prefer to sublicense Licensed Patents and
43
Licensed Copyrights rather than to purchase Licensed Products
on an OEM basis, LICENSEE'S sublicenses may satisfy this OEM
performance obligation.
B.5.5 LICENSEE will release for distribution and offer first sale of
Licensed Products in the Field of Use for brachytherapy by the
later date of either October 1, 2002, or within sixty (60)
days after the date of FDA clearance for brachytherapy uses of
Licensed Products.
B.5.6 LICENSEE will release for distribution and offer first sale of
Licensed Products in the Field of Use for inverse treatment
planning by the later date of either October 1, 2002, or
within sixty (60) days after the date of FDA clearance for
inverse treatment planning uses of Licensed Products.
B.5.7 LICENSEE will release for distribution and offer first sale of
Licensed Products in the Field of Use for electron
radiotherapy by the later date of either October 1, 2002, or
within sixty (60) days after the date of FDA clearance for
electron radiotherapy uses of Licensed Products.
B.5.8 The sales and other performance requirements specified above
may, by mutual written consent of LICENSEE and THE REGENTS, be
amended and/or extended at the written request of LICENSEE to
THE REGENTS, based upon legitimate business or technical
reasons specified in reasonable detail in such written
request. THE REGENTS will not unreasonably withhold its
consent to requests made in accordance with this paragraph.
B.5.9 ThefirstprogressreportwillbedueonFebruary28,2000.
B.6 OPTION RIGHT
44
THE REGENTS also grants to LICENSEE an option to negotiate terms under
which THE REGENTS will add protons, neutrons or both particles to the
Field of Use as otherwise defined in B.1.3 above (Option). The term of
the Option will be eighteen (18) months from the Effective Date.
LICENSEE may exercise this Option by providing THE REGENTS a written
plan (Plan) for the development and commercialization of Licensed
Products in the expanded Field of Use (Expanded FOU) which Plan is
acceptable to THE REGENTS. LICENSEE will provide the Plan as soon as
practical, but in no case later than fifteen (15) months after the
Effective Date. Upon exercise of the Option, and acceptance of the Plan
by THE REGENTS, THE REGENTS will negotiate in good faith terms for the
Expanded FOU. Terms will include, but not be limited by, specific
performance obligations of LICENSEE pertaining to regulatory approvals
and sales of Licensed Products in the Expanded FOU and additional fees,
royalties, or other compensation for the rights obtained by LICENSEE
under the Option.
45
EXHIBIT C - FEES AND ROYALTIES
NOTICE
LICENSEE CONSIDERS INFORMATION IN THIS EXHIBIT C TO BE PROPRIETARY.
C.1 LICENSE ISSUE FEE
C.1.1 As partial consideration for this Agreement, LICENSEE will pay
to THE REGENTS a nonrefundable issue fee of Three Hundred
Thousand Dollars ($300,000.00) (License Issue Fee) as follows:
C.1.1.1 Fifty Thousand Dollars ($50,000.00) to be paid when
LICENSEE executes the Agreement.
C.1.1.2 Fifty Thousand Dollars ($50,000.00) to be paid no
later than October 1, 1999.
C.1.1.3 Fifty Thousand Dollars ($50,000.00) to be paid no
later than November 1, 1999.
C.1.1.4 Fifty Thousand Dollars ($50,000.00) to be paid no
later than December 1, 1999.
C.1.1.5 Fifty Thousand Dollars ($50,000.00) to be paid no
later than January 1, 2000.
C.1.1.6 Fifty Thousand Dollars ($50,000.00) to be paid no
later than February 1, 2000.
46
C.1.2 THE REGENTS will execute the Agreement after receipt of
LICENSEE'S executed copies of the Agreement and payment of the
first installment of the License Issue Fee specified in
C.1.1.1 above.
C.1.3 The License Issue Fee will not be credited against any other
royalty or fee due from LICENSEE to THE REGENTS.
C.1.4 In the event that LICENSEE grants sublicenses, LICENSEE will
collect an issue fee equal to or greater than the License
Issue Fee. LICENSEE will pay to THE REGENTS fifty percent
(50%) of any issue fee from sublicensing.
C.2 EARNED ROYALTIES
In addition to the License Issue Fee, LICENSEE will pay THE REGENTS an
earned royalty equal to eight percent (8%) of Net Sales by LICENSEE and
any sublicensees. The earned royalty on sales of any Licensed Product
that is sold as part of a larger product system, shall be based on the
average Net Sales of that Licensed Product sold separately on a non-OEM
basis over the relevant royalty reporting period. For the purposes of
calculating earned royalties, the minimum value of any License Product
shall be Fifty Thousand Dollars ($50,000.00) for the first two (2) full
years after the date of initial release for distribution and offer of
Sales of Licensed Products as specified in B.5.2. The minimum value
shall be Thirty-Five Thousand Dollars ($35,000.00) for the next two (2)
full years, and Twenty-Five Thousand Dollars ($25,000.00) thereafter.
In the event that LICENSEE terminates the WFO without cause and without
funding sufficient to complete the tasks and deliverables specified in
Phase I (Technology Transfer and Clinical Implementation) of Attachment
A to the WFO, the royalty rate specified above will be ten percent
(10%).
47
Payments of earned royalties will be in accordance with the requirements
of Article 4.2 (SUBLICENSING RIGHTS AND OBLIGATIONS), Article 5 (FEES,
ROYALTIES AND PAYMENTS) and Article 7 (PROGRESS AND ROYALTY REPORTS) of
this Agreement.
C.3 MAINTENANCE FEES
Beginning in calendar year 2000, LICENSEE will pay THE REGENTS a
license maintenance fee of Thirty Five Thousand Dollars ($35,000.00)
per calendar year, which will be due according to the schedule in CA.
The maintenance fee in any calendar year will be creditable against the
minimum annual royalty due in the same calendar year.
C.4 MINIMUM ANNUAL ROYALTIES
LICENSEE will pay to THE REGENTS a minimum annual royalty according to
the requirements of Article 5 (FEES, ROYALTIES AND PAYMENTS) and the
schedule below. Earned royalties paid to THE REGENTS for Net Sales
during a calendar year will be accrued and credited against the minimum
annual royalty paid for that same calendar year.
CALENDAR YEAR MINIMUM ANNUAL ROYALTY DUE DATE IN CALENDAR YEAR
------------- ---------------------- -------------------------
2000 $35,000.00 February 28
2001 $135,000.00 February 28
2002 $200,000.00 February 28
2003 $250,000.00 February 28
2004 $325,000.00 February 28
2005 and thereafter for the life of $400,000.00 February 28
this Agreement
48
49
EXHIBIT D - MUTUAL NONDISCLOSURE AGREEMENT
50
