AMENDMENT TWO TO LIMITED EXCLUSIVE PATENT, COPYRIGHT AND TRADEMARK 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....
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CONFIDENTIAL TREATMENT REQUESTED: CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION.
AMENDMENT TWO
TO
LIMITED EXCLUSIVE
PATENT, COPYRIGHT AND
TRADEMARK 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
XXXXXXXX LIVERMORE NATIONAL LABORATORY
UNIVERSITY OF CALIFORNIA
X.X. XXX 000, X-000, XXXXXXXXX, XX 00000
INDUSTRIAL PARTNERSHIPS AND COMMERCIALIZATION
JUNE 2002
***Confidential material redacted and filed separately with the Commission.
License Agreement—LLNL Case Number TL-1613-99
For PEREGRINE(TM) DOSE CALCULATION SYSTEM
For Radiation Treatment Planning
between NOMOS Corporation and
The Regents of the
University of California effective July 20, 1999
This Amendment Two to the License Agreement by and between The Regents of the University of California ("THE REGENTS") and NOMOS Corporation ("LICENSEE") will be effective as of the date of execution of this Amendment by both Parties. This Amendment and the associated License Agreement are subject to overriding obligations to the Federal Government pursuant to the provisions of THE REGENTS' Contract No. W-7405-ENG-48 with the United States Department of Energy ("DOE") for the operation of the Xxxxxxxx Livermore National Laboratory ("LLNL").
This Amendment Two will modify the field of use, some performance obligations, and royalty fees as reflected in the amended Exhibits B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS) and C (FEES AND ROYALTIES). All other terms and conditions remain the same.
Therefore, in consideration of the mutual covenants and obligations recited herein, THE REGENTS and LICENSEE hereby amend the License Agreement as follows:
- 1.
- EXHIBIT B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS) AND EXHIBIT C (FEES AND ROYALTIES) are replaced in their entirety as follows:
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
- B.1.2
- Rights to Licensed Copyrights
Subject to the limitations set forth in this Agreement, THE REGENTS hereby grants to LICENSEE an exclusive, nontransferable, royalty-bearing license to: 1) 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.1.3
- Rights to Licensed Trademarks
- B.1.4
- "Field of Use" means planning human and animal cancer therapies based on tumor radiation with photons or electrons that are generated either by a radiation source external to the patient (teletherapy) or an encapsulated radiation source internal to the patient (brachytherapy).
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.
Subject to the terms and conditions of this Agreement, THE REGENTS hereby grants LICENSEE an exclusive license to use Licensed Trademarks, in corresponding Territories, as specified in Exhibit E (LICENSED TRADEMARKS), on Licensed Products or for Licensed Methods in the Field of Use.
1
- B.2
- SUBLICENSING RIGHTS
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 in such Licensed Patents, Licensed Copyrights, and Licensed Trademarks in the Field of Use at the time of sublicensing. LICENSEE may issue sublicenses to Licensed Trademarks only in conjunction with LICENSEE's sublicensing of Licensed Patents and Licensed Copyrights.
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. In particular, no license, express or implied, is granted to LICENSEE to Licensed Trademarks outside the corresponding Territory as specified in Exhibit E (LICENSED TRADEMARKS).
- 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.
- 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 [***] 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 2004, 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 Licensed Copyrights rather than to purchase Licensed
Notwithstanding any other term of this Agreement, for the purposes of (a) invoking/complying with the Xxxxx-Xxxxxx Act (35 U.S.C. Section 156) and any corresponding rules and regulations of the U.S. 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 extend deemed necessary by LICENSEE, in good faith, the Parties will cooperate to secure regulatory approval of LICENSEE's Licensed Products and Licensed Methods.
2
- 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 [***], 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
[***], 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
[***], 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
- The first progress report will be due on February 28, 2000.
Products on an OEM basis, LICENSEE's sublicenses may satisfy this OEM performance obligation.
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) (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.
- 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.
3
- 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.
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
- 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 | February 28 | ||
2001 |
$135,000 |
February 28 |
||
2002 |
[***] of cumulative annual revenue* sales up to [***] [***] of cumulative annual revenue sales greater than [***] but less than [***] [***] of cumulative annual revenue sales greater than [***] |
February 28 |
||
2003 |
Same as 2002 |
February 28 |
||
2004 |
[***] |
February 28 |
||
2005 and thereafter for the life of this Agreement |
$400,000.00 |
February 28 |
- *
- As used herein, the term "cumulative annual revenue" means any revenue generated from sales of the Licensed Products or use of the Licensed Methods, accumulated or realized during the period January 1 to December 31 of a given year, in this instance, the years 2002, and 2003.
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THE REGENTS and LICENSEE execute this Amendment, in duplicate originals, by their respective officers who are duly authorized on the day and year that is written.
NOMOS CORPORATION |
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA |
|||
XXXXXXXX LIVERMORE NATIONAL LABORATORY |
||||
By: |
/s/ XXXX X. XXXXXXX (Signature) |
By: |
/s/ XXXXXX XXXXXXXX (Signature) |
|
Name: | Xxxx X. Xxxxxxx |
Name: | Xxxxxx XxXxxxxx |
|
Title: | VP—Engineering & Development |
Title: | Director, IPAC |
|
Date signed: June 3, 2002 |
Date signed: June 4, 2002 |
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License Agreement—LLNL Case Number TL-1613-99 For PEREGRINE(TM) DOSE CALCULATION SYSTEM For Radiation Treatment Planning between NOMOS Corporation and The Regents of the University of California effective July 20, 1999
EXHIBIT B—RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS
EXHIBIT C—FEES AND ROYALTIES NOTICE