Limited Exclusive License Agreement

Contract Categories: Intellectual Property - License Agreements
EX-10.4 5 c26124exv10w4.htm LIMITED EXCLUSIVE LICENSE AGREEMENT exv10w4
 

Exhibit 10.4
LIMITED EXCLUSIVE
PATENT LICENSE AGREEMENT
For
DIELECTRIC WALL ACCELERATOR TECHNOLOGY
For Particle and Radiotherapy
Between
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
and
TOMOTHERAPY INCORPORATED
LLNL Case No. TL02168-0.0
Lawrence Livermore National Laboratory
University of California
P.O. Box 808, L-795, Livermore, CA 94551
Industrial Partnerships and Commercialization
February 23, 2007
Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [ * ]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

 


 

TABLE OF CONTENTS
             
1.
  BACKGROUND     1  
2.
  DEFINITIONS     4  
3.
  LICENSE GRANT     9  
4.
  SUBLICENSING RIGHTS AND OBLIGATIONS     9  
5.
  FEES, ROYALTIES, AND PAYMENTS     10  
6.
  DUE DILIGENCE     13  
7.
  ROYALTY AND PROGRESS REPORTS     15  
8.
  BOOKS AND RECORDS     17  
9.
  LIFE OF THE AGREEMENT     17  
10.
  TERMINATION     18  
11
  DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION     19  
12.
  PATENT PROSECUTION AND MAINTENANCE     20  
I3.
  PATENT INFRINGEMENT     22  
14.
  USE OF NAMES AND TRADEMARKS     25  
15.
  LIMITED WARRANTY     25  
16.
  INDEMNIFICATION     26  
17.
  INSURANCE     27  
18.
  WAIVER     28  
19.
  ASSIGNABILITY     28  
20.
  LATE PAYMENTS     29  
21.
  NOTICES     29  
22.
  GOVERNING LAWS; VENUE; ATTORNEYS FEES     30  
23.
  PATENT MARKING     31  
24.
  GOVERNMENT APPROVAL OR REGISTRATION     31  
25.
  COMPLIANCE WITH LAWS     31  
26.
  FORCE MAJEURE     32  
27.
  UNITED STATES PREFERENCE     32  
28.
  PROPRIETARY INFORMATION     33  
29.
  MISCELLANEOUS     33  
EXHIBIT A — LICENSED PATENTS     35  
EXHIBIT B — RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS     38  
EXHIBIT C — FEES AND ROYALTIES     43  
EXHIBIT D — MUTUAL NONDISCLOSURE AGREEMENT     46  
EXHIBIT E — SCHEDULE     47  

i


 

LIMITED EXCLUSIVE PATENT LICENSE AGREEMENT
For DIELECTRIC WALL ACCELERATOR
For Particle and Radiotherapy
This license agreement (“Agreement”) is effective on the Effective Date by and between The Regents of the University of California (“THE REGENTS”), under its United States Department of Energy (“DOE”) Contract No. W-7405-ENG-48 to manage and operate Lawrence Livermore National Laboratory (“LLNL”), and TomoTherapy Incorporated (“LICENSEE”) a Wisconsin corporation having its principal place of business at 1240 Deming Way, Madison, Wisconsin 53717. THE REGENTS is a corporation organized and existing under the laws of the State of California, with its principal office at 1111 Franklin Street, 12th Floor, Oakland, California ###-###-####. THE REGENTS and LICENSEE are referred to jointly as “Parties.” This Agreement and the resulting license are subject to overriding obligations to the Federal Government pursuant to the provisions of THE REGENTS’ Contract No. W-7405-ENG-48 with the DOE for the operation of the LLNL and DOE’s grant of patent rights to THE REGENTS.
1.   BACKGROUND
 
1.1   Certain inventions characterized as Dielectric Wall Accelerator (“DWA”) technology (“Invention”) described in LLNL patent applications and patents listed in Exhibit A (LICENSED PATENTS), which may be useful for the production of Particle and Radiotherapy systems, were made at LLNL and are covered by THE REGENTS’ Patent Rights as defined in Article 2 (DEFINITIONS).
 
1.2   LICENSEE entered into a Mutual Nondisclosure Agreement provided in Exhibit D (MUTUAL NONDISCLOSURE AGREEMENT), which is incorporated herein, that allowed LICENSEE to evaluate its interest in taking a license to the Invention.
 
1.3   THE REGENTS grants to the U.S. Government a nontransferable, paid-up, nonexclusive, irrevocable license to use the Invention by, or on behalf of, the U.S. Government throughout the world.

1


 

1.4   LICENSEE and THE REGENTS are parties to a cooperative research and development agreement referred to hereafter as the “CRADA” Agreement No. TC02109.0 as amended, for purposes of developing a Particle and Radiotherapy System based on LLNL’s DWA technology.
 
1.5   LICENSEE is interested in acquiring certain rights to those patents and patent applications listed in Exhibit A (LICENSED PATENTS) of this Agreement, and any additional patents, patent applications, and copyrightable works developed under the Statement of Work of the CRADA and by the LLNL DWA team on related projects that would be useful for the development, manufacture, and use of the technology. THE REGENTS is willing to grant such rights so that the DWA technology may be developed and used to the fullest extent for the benefit of the U.S. economy and the general public.
 
1.6   The Field of Use of this Agreement is Particle and Radiotherapy. LICENSEE will initially develop a proton therapy system incorporating Licensed Patents, and LICENSEE submitted to THE REGENTS an acceptable commercialization plan for proton therapy on June 30, 2006. LICENSEE understands and agrees that in order to maintain exclusivity for Particle and Radiotherapy that it must submit additional acceptable commercialization plans to THE REGENTS as required by Exhibit B of this Agreement.
 
1.7   THE REGENTS wishes to grant the following rights to LICENSEE so that the products and other benefits derived from the Invention can be enjoyed by the general public.
 
1.8   The scope of such rights granted by THE REGENTS is intended to extend to the scope of the patents and patent applications pertaining to the Invention (but only to the extent that THE REGENTS has Valid Claims of such Patent Rights) and to that material which is otherwise necessary to utilize the Patent Rights, as described herein, which may include copyrightable material.
 
1.9   THE REGENTS has informed LICENSEE, and LICENSEE understands that the Invention is a research product from a national laboratory and requires additional development for its commercialization. Other than as may be agreed to by the Parties pursuant to agreements other than this Agreement, as between THE REGENTS and

2


 

LICENSEE, LICENSEE agrees it is solely responsible for the additional development of the Invention for commercialization purposes.
1.10   LICENSEE is a “small entity” as defined in 37 CFR § 1.27.
 
1.11   LICENSEE is a “small business firm” as defined at Section 2 of Pub. L. 85-536 (15 U.S.C. § 632).
 
1.12   The Parties intend that royalties due under this Agreement will be calculated and paid on Sales of the Licensed Products or Licensed Services by LICENSEE.
 
1.13   LICENSEE recognizes the need to practice due diligence in the development of Licensed Patents in accordance with the Agreement’s terms and conditions to maintain the license. In addition, both Parties acknowledge that the U.S. Government has certain march-in rights in accordance with 48 CFR 27.304-1 (g) and 15 USC 3710a(b)(l)(B) and (C).
 
1.14   As of the Effective Date, THE REGENTS has no knowledge of any pending or threatened claim related to the Licensed Patents or the Licensed Method, and it has not granted to any third party any license, option, or other right that conflicts with, or could conflict with, if exercised, the license, options, and other rights granted by it under this Agreement.
 
1.15   LICENSEE and THE REGENTS will assess and amend Exhibit A (LICENSED PATENTS) after completion and full testing of the sub-scale prototype of the DWA in order to determine the Licensed Patents needed for commercialization. The Parties will continue to assess and amend Exhibit A (LICENSED PATENTS) during the course of the CRADA that is currently negotiated with LICENSEE. During this period, THE REGENTS agree to add additional rights to Category 1 Patents, Category 2 Patents, and Category 3 Patents as reasonably necessary to commercialize the Invention in accordance with the provisions herein.
THEREFORE, the Parties agree as follows:

3


 

2.   DEFINITIONS
 
    As used in this Agreement, the following terms, whether used in the singular or plural, will have the following meanings:
 
2.1   “Affiliate” of LICENSEE means any entity which, directly or indirectly, Controls LICENSEE, is Controlled by LICENSEE, or is under common Control with LICENSEE. “Control” means (i) having the actual, present capacity to elect a majority of the directors of such affiliate, (ii) having the power to direct at least fifty percent (50%) of the voting rights entitled to elect directors, or (iii) in any country where the local law will not permit foreign equity participation of a majority, ownership or control, directly or indirectly, of the maximum percentage of such outstanding stock or voting rights permitted by local law. LICENSEE does not include “Affiliate.”
 
2.2   “Effective Date” means the date of execution by the last signing Party and payment of the License Issue Fee pursuant to Paragraph C. 1.1 in Exhibit C (FEES AND ROYALTIES).
 
2.3   “Field of Use” is the application or use defined in Exhibit B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS).
 
2.4   “Joint Venture” means any separate legal entity established pursuant to an agreement between a third party and LICENSEE and/or sublicensee to constitute a vehicle for a joint effort, in which the separate entity manufactures, uses, purchases, Sells, or acquires Licensed Products from LICENSEE. LICENSEE does not include “Joint Venture.”
 
2.5   “Licensed Method” means any process or method the use or practice of which, but for the license granted in this Agreement, would infringe, or contribute to, or induce the infringement of, any Patent Rights.
 
2.6   “Licensed Patents” means:
  2.6.1   U.S. patents and U.S. patent applications specified in Exhibit A (LICENSED PATENTS), and U.S. patents resulting from these applications, continuations of these applications, divisionals, and continuation-in-part applications resulting from these applications only to the extent, however, that Valid Claims in the

4


 

continuation-in-part applications are entirely supported in the specification and entitled to the priority date of the parent application;
  2.6.2   reissues of 2.6.1.
 
  2.6.3   foreign patent applications filed under Article 12 (PATENT PROSECUTION AND MAINTENANCE) and patents resulting from these applications, continuations of these applications, divisionals, and continuation-in-part applications only to the extent, however, that Valid Claims in the continuation-in-part are entirely supported in the specification and entitled to the priority date of the patent application; provided LICENSEE has not breached any obligation to pay foreign fees set forth in this Agreement.
2.7   “Licensed Product” means all kits, compositions of matter, materials, articles of manufacture, and products the manufacture, use, Sale, offer for Sale, or import of which, but for the license granted in this Agreement, would infringe, or contribute to or induce the infringement of any Patent Rights, or would require the performance of the Licensed Method.
 
2.8   “Licensed Service” means the use of Licensed Products or Licensed Method to provide a service. Neither Licensed Service nor Licensed Method includes the maintenance or servicing of a Licensed Product.
 
2.9   “Net Invoice Price” means the gross invoice selling price by the ultimate seller (whether LICENSEE or a sublicensee) for the Sale of a Licensed Product or Licensed Service, less the following items, but only to the extent that they actually pertain to the Sale of such Licensed Product or Licensed Service:
  2.9.1   Allowances actually granted to customers for rejections, returns, and prompt payment and volume discounts (in amounts customary to the trade);
 
  2.9.2   Freight, transport packing, insurance charges associated with transportation; and

5


 

  2.9.3   Taxes (including without limitation, sales and use taxes), tariffs or import/export duties based on Sales when included in the gross invoice price, but not value-added taxes or taxes assessed on income derived from Sales.
2.10   “Net Sale” means the Net Invoice Price, except in the instances described in Subparagraphs (2.10.1), (2.10.2), (2.10.3) and (2.10.4) of this Paragraph.
  2.10.1   For any Relationship-Influenced Sale of a Licensed Product or Licensed Service, Net Sales will be based on the Net Invoice Price at which the Relationship-Influenced Sale Purchaser resells such Licensed Product or Licensed Service;
 
  2.10.2   In those instances where Licensed Product or Licensed Service is not Sold, but is otherwise exploited, the Net Sales for such Licensed Product or Licensed Service will be the Net Invoice Price of products or services of similar kind and quality, Sold in similar quantities, currently being offered for Sale by LICENSEE and/or any sublicensee. Where such products or services are not currently Sold or offered for Sale by LICENSEE and any sublicensees, or others, then the Net Sales will be LICENSEE’s and/or any sublicensee’s cost of manufacture of Licensed Product or the cost of conducting the service, determined by LICENSEE’s and/or any sublicensee’s customary accounting procedures, plus LICENSEE’s average gross margin less any amounts attributable to the items set forth in Paragraphs 2.9.1 through 2.9.3 above;
 
  2.10.3   In those instances where LICENSEE or a sublicensee acquires and subsequently Sells Licensed Product or Licensed Service previously Sold to which an earned royalty accrued hereunder, Net Sales will mean the Net Invoice Price upon Sale of such Licensed Product or Licensed Service, as applicable, by LICENSEE or the sublicensee, less the Net Invoice Price of the immediately preceding Sale to LICENSEE or such sublicensee.
 
  2.10.4   In those instances where LICENSEE or a sublicensee leases Licensed Products or otherwise provides Licensed Products or Licensed Services to a third party for consideration paid over a period of time, Net Sales will mean the Net Invoice

6


 

Price of each such discrete payment actually made by the third party to LICENSEE, less any amounts attributable to the items set forth in Paragraphs 2.9.1 through 2.9.3 above.
2.11   “New Developments” means inventions, or claims to inventions, which constitute advancements, developments or improvements, whether or not patentable and whether or not the subject of any patent application, which are: (a) not sufficiently supported by the specification of a previously-filed patent or patent application within the Patent Rights to be entitled to the priority date of the previously-filed patent or patent application; and (b) not otherwise commercially valuable to LICENSEE’s commercialization of the Licensed Patents within the Field of Use.
 
2.12   “Patent Rights” means the Valid Claims of, to the extent assigned to, or otherwise obtained by, THE REGENTS, in Licensed Patents. This definition of Patent Rights excludes any rights in and to New Developments.
 
2.13   “Related Party” means a corporation, firm or other entity with which, or individual with whom, LICENSEE and or any sublicensee (or any of their respective stockholders, subsidiaries or Affiliates) have an agreement, understanding, or arrangement (for example, but not by way of limitation, an option to purchase stock or other equity interest, or an arrangement involving a division of revenue, profits, special discounts, rebates, or allowances) which is entirely unrelated to the Sale or exploitation of the Licensed Products or Licensed Services without which such other agreement, understanding, or arrangement, the amounts, if any, charged by LICENSEE or sublicensee to such entity or individual for the Licensed Product or Licensed Service would be higher than the Net Invoice Price actually received.
 
2.14   “Relationship-Influenced Sale” means a Sale of a Licensed Product, or any exploitation of the Licensed Product or Licensed Method, by LICENSEE and/or any sublicensee to (i) an Affiliate; (ii) a Joint Venture; or (iii) a Related Party.
 
2.15   “Relationship-Influenced Sale Purchaser” means the purchaser of Licensed Product or Licensed Service in a Relationship-Influenced Sale.

7


 

2.16   “Sale” means the act of selling, leasing or otherwise transferring, providing, or furnishing for use for any consideration. Correspondingly, “Sell” means to make or cause to be made a Sale, and “Sold” means to have made or caused to be made a Sale. It shall not be deemed a Sale under this Agreement for LICENSEE to transfer any Licensed Products to a customer, where the customer utilized the Licensed Products predominantly for research purposes and LICENSEE receives for such Licensed Products an amount equal to or less than LICENSEE’s actual cost to manufacture such Licensed Products.
 
2.17   “Valid Claim” means a claim of a patent or patent application in any country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been cancelled or superseded, or if cancelled or superseded, has been reinstated; and (iv) has not been revoked, held invalid, or otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such country from which no further appeal has or may be taken.
 
2.18   “Particle and Radiotherapy” means the medical use of x-rays, protons, and light and heavy ion charged particles in therapeutic applications.
 
2.19   “Isotope generation” means the production of radioisotopes, e.g., F-18 fluorodeoxygluscose (F-18 FDG) and other radiopharmaceuticals for diagnostic applications.
 
2.20   “Category 1 Patents” means patents resulting from patent applications and records of invention in the Field of Use that were generated by the LLNL DWA team and in existence prior to the Effective Date of this Agreement.
 
2.21   “Category 2 Patents” means patents resulting from patent applications and records of invention in the Field of Use that were generated by the LLNL DWA team during the course of the CRADA, but funded by parties other than LICENSEE. LICENSEE understands that since Category 2 Patents are generated by funds from parties other than LICENSEE, access to Category 2 Patents entails the possibility of additional license fees due at the time that Category 2 Patents may be added to this Agreement by amendment, such additional license fees being subject to the limitations described in this Agreement.

8


 

2.22   “Category 3 Patents” means patents resulting from patent applications and records of invention generated by the LLNL DWA team during the course of the CRADA in the Field of Use funded by LICENSEE.
 
2.23   “First Commercial Acceptance” means the first sign-off of an acceptance of a Licensed Product by a customer of LICENSEE that is not an Affiliate.
 
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 license granted hereunder will be subject to the overriding obligations to the U.S. Government including those set forth in 35 U.S.C. §200-212 and applicable governmental implementing regulations and the obligation to report on utilization of the Invention set forth in 37 CFR §401.14(h).
 
3.3   Subject to its compliance with the terms of Exhibit D (MUTUAL NONDISCLOSURE AGREEMENT), nothing in this Agreement will be deemed to limit the right of THE REGENTS to publish any and all technical data resulting from any research performed by THE REGENTS relating to the Licensed Patents and to make, use or practice the Invention, Licensed Product, Licensed Service, Licensed Method, and associated technology, and allow other educational and non-profit institutions to do so solely 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 (Sublicensing Rights).
 
4.2   LICENSEE must include in any sublicense all the rights and obligations due THE REGENTS and the Government set forth in Paragraphs 1.13 and 3.2 of this Agreement.

9


 

4.3   LICENSEE must require sublicensees to provide it with copies of all progress reports and royalty reports in accordance with the provisions of this Agreement, and LICENSEE will collect and deliver to THE REGENTS all such reports due from sublicensees.
 
4.4   LICENSEE must include in all sublicenses the notice that upon termination of this Agreement for any reason, THE REGENTS, at its sole discretion, will determine whether any or all sublicenses will be canceled or assigned to THE REGENTS.
 
4.5   LICENSEE will notify THE REGENTS of each sublicense granted hereunder and provide THE REGENTS with a complete copy of each executed sublicense within thirty (30) days of issuance of the sublicense.
 
4.6   Consideration owed to THE REGENTS will be paid to THE REGENTS on or before the due date of the royalty report applicable to the quarter in which consideration was finally due and owing to LICENSEE under the sublicense. LICENSEE will collect from the sublicensees and will pay to THE REGENTS all fees, royalties, and the cash equivalent of any consideration due THE REGENTS.
 
5.   FEES, ROYALTIES, AND PAYMENTS
 
5.1   Fees and royalties due on Net Sales of Licensed Products or Licensed Services will be as specified in this Article 5, Exhibit C (FEES AND ROYALTIES), and Article 7 (ROYALTY AND PROGRESS REPORTS) of this Agreement.
 
5.2   As partial consideration for the rights granted to LICENSEE, LICENSEE will pay to THE REGENTS a license issue fee as set forth in Exhibit C.
 
5.3   As partial consideration for the rights granted to LICENSEE, LICENSEE will pay to THE REGENTS milestone payments as set forth in Exhibit C.
 
5.4   As partial consideration for all the rights granted to LICENSEE, LICENSEE will pay THE REGENTS minimum annual royalties as set forth in Exhibit C.
 
5.5   As partial consideration for all the rights granted to LICENSEE, LICENSEE will pay to THE REGENTS earned royalties at the rate set forth in Exhibit C.

10


 

5.6   Earned royalties shall accrue when LICENSEE receives payment for Licensed Products or Licensed Services, or if no such payment is to be received, when such Licensed Products or Licensed Services are delivered in a manner constituting a Net Sale as defined in Article 2 (DEFINITIONS), Paragraph 2.10, and no further deliverables are due to the customer by LICENSEE or sublicensee.
 
5.7   Payment for earned royalties will include all royalties accrued up to the last day of the most recently completed calendar quarter, and such payment shall be made on the dates specified below:
 
    February 28 for the calendar quarter ending December 31;
 
    May 31 for the calendar quarter ending March 31;
 
    August 31 for the calendar quarter ending June 30; and
 
    November 30 for the calendar quarter ending September 30.
 
5.8   All consideration due THE REGENTS shall be payable in United States dollars. When Licensed Products or Licensed Services are sold for monies other than United States dollars, earned royalties will first be determined in the foreign currency of the country in which such Licensed Products or Licensed Services were Sold and then converted into equivalent United States dollars. The exchange rate will be the one actually used by LICENSEE to record such sale on its financial statements.
 
5.9   Earned royalties on Sales of Licensed Products or Licensed Services occurring in any country outside the United States shall not be reduced by any taxes, fees, or other charges imposed by the government of such country except those taxes, fees, and charges allowed under the provisions of Paragraph 2.9 (Net Invoice Price). LICENSEE also will be responsible for all bank transfer charges.
 
5.10   Notwithstanding the provisions of Article 26 (FORCE MAJEURE), if at any time legal restrictions prevent prompt remittance of any earned royalties or other consideration owed to THE REGENTS by LICENSEE with respect to any country where a sublicense is issued or a Licensed Product or Licensed Service is Sold, then LICENSEE will convert the amount owed to THE REGENTS into United States dollars and will pay THE

11


 

    REGENTS directly from another source of funds in order to remit the entire amount owed to THE REGENTS. Notwithstanding the previous sentence, if LICENSEE is prohibited itself by such legal restrictions from collecting the Net Invoice Price for the sale of any Licensed Product or Licensed Service or any royalty or fee from a sublicense, LICENSEE shall not be obligated to convert such amount owed, but rather will send written notice to THE REGENTS of such legal restrictions and of the amount owed. Upon removal of such legal restrictions, LICENSEE will convert said amount owed to THE REGENTS into United States dollars and will remit the entire amount owed to THE REGENTS.
 
5.11   No earned royalties will be collected or paid hereunder to THE REGENTS on Licensed Products or Licensed Services Sold to the account of the U.S. Government. LICENSEE and its sublicensee will reduce the amount charged for Licensed Products or Licensed Services Sold to the U.S. Government by an amount equal to the royalty for such Licensed Products or Licensed Services otherwise due THE REGENTS. LICENSEE will provide THE REGENTS with U.S. Government contract numbers and a written statement by LICENSEE’s contracting officer that Sale of Licensed Products to the U.S. Government were reduced by the amount of royalty due THE REGENTS.
 
5.12   If THE REGENTS must pursue legal means to obtain payments owed by LICENSEE, LICENSEE will pay THE REGENTS for all reasonable legal costs and any other related costs expended by THE REGENTS to collect payments owed by LICENSEE.
 
5.13   In the event that any patent or any claim thereof included within the Patent Rights is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, all obligation to pay royalties based on such patent or claim or any claim patentably indistinct there from will cease as of the date of such final decision. LICENSEE will not, however, be relieved from paying any royalties that accrued before such final decision and LICENSEE will be obligated to pay the full amount of royalties due hereunder to the extent that THE REGENTS licenses one or more Valid Claims within the Patent Rights to LICENSEE with respect to Licensed Products or Licensed Services.

12


 

6.   DUE DILIGENCE
 
6.1   LICENSEE, upon execution of this Agreement, will use all commercially reasonable efforts to diligently proceed with the development, manufacture, and Sale of Licensed Products and Licensed Services and use of Licensed Methods, and will use all commercially reasonable efforts to earnestly and diligently market the same after execution of this Agreement and in quantities sufficient to meet the market demands therefore.
 
6.2   LICENSEE will meet the specific performance obligations and milestones specified in Exhibit B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS), in accordance with the terms and conditions therein (including, without limitation, the cure periods and potential modifications to such time periods therein). If LICENSEE is unable to meet such milestones in accordance with Exhibit B, the Parties will use all reasonable efforts to negotiate a new schedule and the conditions for continuation of a limited exclusive license.
  6.2.1   If the missed milestone occurs within [ * ] of the Effective Date, the Parties will agree on a new schedule.
 
  6.2.2   If the missed milestone occurs between the[ * ] and[ * ] year after the Effective Date, and the Parties are unable to reach agreement on a new schedule, THE REGENTS will have the right to convert the limited exclusive license for Licensed Patents to a nonexclusive license.
 
  6.2.3   If the missed milestone occurs [ * ]  years after the Effective Date, THE REGENTS will have the right and option to: (a) convert the limited exclusive license for Licensed Patents to a nonexclusive license; or (b) terminate this Agreement per Article 10 (TERMINATION), Paragraph 10.1 (Termination by THE REGENTS), subject to the provisions described in Article 11 (DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION).

13


 

6.3   LICENSEE will comply with all applicable governmental laws and obtain all necessary governmental approvals in each country where Licensed Products or Licensed Services are manufactured, used, Sold, imported, or offered for Sale.
 
6.4   THE REGENTS will notify LICENSEE if THE REGENTS is approached by a third party seeking a license to make, use, or sell the Invention or the Licensed Products in LICENSEE’s Field of Use because commercial demand is not then being met. LICENSEE will negotiate in good faith with that third party to grant a sublicense for any Licensed Patents 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, and may be granted or denied in LICENSEE’s reasonable business judgment, provided, however, that LICENSEE provides THE REGENTS with a justification (which shall be treated as Proprietary Information) 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. Upon filing bankruptcy, the license terminates at THE REGENTS’s option as stated in Article 9 (LIFE OF THE AGREEMENT), Paragraph 9.2.
 
6.6   To exercise either the right to terminate this Agreement or to reduce the exclusive licenses granted to LICENSEE to nonexclusive licenses for lack of diligence required in this Article 6, THE REGENTS will give LICENSEE written notice, setting forth specific details as to the nature of the alleged deficiency. LICENSEE thereafter has sixty (60) days to cure the deficiency. If THE REGENTS has not received written tangible evidence satisfactory to THE REGENTS that the deficiency has been cured by the end of the sixty-(60) day period, then THE REGENTS may, at its option, terminate this Agreement immediately without the obligation to provide sixty (60) days’ notice as set forth in Paragraph 10.1 or reduce the exclusive licenses granted to LICENSEE to nonexclusive licenses by giving written notice to LICENSEE.

14


 

7.   ROYALTY AND PROGRESS REPORTS
 
7.1   LICENSEE will submit to THE REGENTS an annual progress report as described in Paragraph 7.2 below covering activities by LICENSEE and its sublicensees related to the development and testing of all Licensed Products and Licensed Services. Such progress report will be signed by LICENSEE’s President or his/her designee attesting to the accuracy of the information in the report. If LICENSEE fails to submit a timely progress report to THE REGENTS, THE REGENTS will be entitled to terminate this Agreement in accordance with the material breach provision set forth in Paragraph 10.1. If either party terminates this Agreement before any Licensed Products or Licensed Services are Sold or before this Agreement’s expiration, a final progress report covering the period prior to termination must be submitted within thirty (30) days of termination.
 
7.2   The progress reports submitted under Paragraph 7.1 above will include, but not be limited to, a reasonably detailed summary of the following topics:
    Summary of work completed toward commercialization of Licensed Patents;
 
    Schedule of anticipated events or milestones, including status of those events or milestones. Should LICENSEE wish to change the schedule of events or milestones specified in Exhibit B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS), LICENSEE must request advance written approval from THE REGENTS;
 
    A financial statement showing the investments made in the commercialization effort to date;
 
    Anticipated and actual market introduction dates of each Licensed Product or Licensed Service;
 
    Summary of marketing and sales activities, including copies of marketing and sales literature; and
 
    activities of the sublicensees, if any.
7.3   LICENSEE also will report to THE REGENTS in its immediately subsequent progress report the date of first Sale or other exploitation of a Licensed Product or Licensed Service in each country.

15


 

7.4   Beginning with the quarter following First Commercial Acceptance, LICENSEE will provide quarterly royalty reports and payments to THE REGENTS on or before each February 28, May 31, August 31, and November 30 of each year. If there were no Sale of Licensed Products or Licensed Services, the report will state that. Royalty reports will be signed by LICENSEE’s President or Chief Financial Officer, or their designee, attesting to the accuracy of the report. Each such royalty report will cover the most recently completed calendar quarter (October through December covered in the February 28th report, January through March in the May 31st report, April through June in the August 31st report, and July through September in the November 30th report) and will show:
  7.4.1   the gross invoice prices and Net Sales of Licensed Products or Licensed Services Sold or otherwise exploited by LICENSEE and its sublicensees during the most recently completed calendar quarter;
 
  7.4.2   the number of Licensed Products or Licensed Services Sold or otherwise exploited by LICENSEE and its sublicensees during the most recently completed calendar quarter;
 
  7.4.3   the place of manufacture of Licensed Products or practice of Licensed Services;
 
  7.4.4   the royalties, in U.S. dollars, payable hereunder with respect to Net Sales;
 
  7.4.5   the method used to calculate the royalty, specifying all deductions taken and the dollar amount of each such deduction; and
 
  7.4.6   the exchange rates used, if any.
7.5   LICENSEE will provide THE REGENTS with an annual statement of royalty accounts within sixty (60) days after the financial closing of LICENSEE’s fiscal year. THE REGENTS will protect such statements, and any of the other reports provided to THE REGENTS pursuant to Article 7, as Proprietary Information and not disseminate them unless required by law. If a disclosure is required by law, THE REGENTS will give LICENSEE the opportunity to seek a protective order preventing or limiting such disclosure.

16


 

8.   BOOKS AND RECORDS
 
8.1   LICENSEE will keep books and records accurately showing all payments due THE REGENTS and all Licensed Products and Licensed Services manufactured (including place of manufacture), used, offered for Sale, imported, and/or Sold under the terms of this Agreement. Such books and records will be preserved for at least five (5) years after the date of the payment to which they pertain and will be open to inspection by representatives or agents of THE REGENTS at reasonable times and upon reasonable prior notice to determine their accuracy and assess LICENSEE’s compliance with the terms of this Agreement.
 
8.2   The fees and expenses of representatives of THE REGENTS performing such an examination will be borne by THE REGENTS. If, however, an underpayment error in royalties of more than five percent (5%) of the total royalties due for any year is discovered, LICENSEE will bear the reasonable costs associated with the examination and will remit such underpayment to THE REGENTS within thirty (30) days of the examination result.
 
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, and THE REGENTS will treat such reports as Proprietary Information to the extent the same is not part of a public filing. 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.   LIFE OF THE AGREEMENT
 
9.1   Unless otherwise terminated by operation of law, Paragraph 9.2, or by acts of the Parties in accordance with the terms of this Agreement, this Agreement will remain in effect from the Effective Date until the expiration or abandonment of last of the Patent Rights licensed hereunder, at which point this Agreement will expire.
 
9.2   This Agreement will terminate at THE REGENTS’s option upon the filing of a petition for relief under the United States Bankruptcy Code by LICENSEE. If the bankruptcy

17


 

    petition is filed against LICENSEE by a third party, LICENSEE has sixty (60) days from the date of the petition to have such third-party bankruptcy filing dismissed. If at the end of the sixty (60) day period, LICENSEE fails to have the third party filing dismissed, this Agreement will automatically terminate.
 
9.3   Any termination of this Agreement will not affect the rights and obligations set forth in the following Articles: Article 2 (DEFINITIONS), Article 5 (FEES, ROYALTIES, AND PAYMENTS), Article 8 (BOOKS AND RECORDS), Article 9 (LIFE OF THE AGREEMENT), Article 11 (DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION), Article 14 (USE OF NAMES AND TRADEMARKS), Article 15 (LIMITED WARRANTY), Article 16 (INDEMNIFICATION), Article 17 (INSURANCE), Article 21 (NOTICES), Article 22 (GOVERNING LAWS; VENUE; ATTORNEYS’ FEES), and Article 28 (PROPRIETARY INFORMATION), subject to any time limitations set forth in those Articles. Notwithstanding anything herein to the contrary, LICENSEE shall have no obligation to pay any amount under this Agreement unless such amount was due and owing prior to the termination or expiration of this Agreement.
 
9.4   The termination or expiration of this Agreement will not relieve LICENSEE of its obligation to pay any fees, royalties, and reimbursements for foreign filing costs, or other payments owed to THE REGENTS at the time of such termination or expiration and will not impair any accrued right of THE REGENTS.
 
10.   TERMINATION
 
10.1   Termination by THE REGENTS: If LICENSEE fails to perform any material term or covenant of this Agreement, except for failure to meet a performance obligation which is specifically addressed in Paragraph 6.2, 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.

18


 

10.2   Termination by LICENSEE: LICENSEE will have the right at any time to terminate this Agreement by providing a Notice of Termination to THE REGENTS and paying any outstanding fees owed THE REGENTS. Termination of this Agreement will be effective sixty (60) days after the date such notice takes effect.
 
10.3   This Agreement will terminate, effective ten (10) days after the effective date of notice by THE REGENTS, if LICENSEE is dissolved or liquidated.
 
11.   DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION
 
11.1   Upon termination of this Agreement pursuant to Article 10 (TERMINATION), LICENSEE may Sell all previously made or partially made Licensed Products (and such partially made Licensed Products may be completed prior to Sale), but will not make or Sell additional Licensed Products, provided, however, that the Sale of such Licensed Products will be subject to the terms of this Agreement including, but not limited to, the payment of earned royalties at the rates and at the times provided herein and the rendering of reports in connection therewith LICENSEE will also be permitted to provide Licensed Services for so long as is reasonably necessary to complete those contractual obligations of LICENSEE accruing prior to termination or expiration of this Agreement, provided that LICENSEE’s providing of such Licensed Services will be subject to the terms of this Agreement, including, but not limited to, the payment of earned royalties at the rates and at the times provided herein and the rendering of reports in connection herewith.
 
11.2   Within thirty (30) days after termination of this Agreement by either Party pursuant to Article 10 (TERMINATION), 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 provided that LICENSEE pays royalties to THE REGENTS on such dispositions.
 
11.3   Upon termination of this Agreement pursuant to Article 10 (TERMINATION), LICENSEE may not practice Licensed Methods after the date of termination of this

19


 

    Agreement except as necessary to complete the manufacture of Licensed Products as permitted under Paragraph 11.2 and to provide Licensed Services as described in Paragraph 11.1.
 
12.   PATENT PROSECUTION AND MAINTENANCE
 
12.1   THE REGENTS will prosecute U.S. patent applications and maintain U.S. patents licensed under this Agreement. In accordance with Paragraph 1.15, upon completion of the sub-scale prototype of the DWA (estimated to be [ * ]), LICENSEE and THE REGENTS will review and amend Exhibit A (LICENSED PATENTS) in this License so that the amended list of Licensed Patents will be those that both Parties believe are necessary for commercialization of Licensed Products. THE REGENTS recognizes that the list of Licensed Patents may be amended periodically during the course of the CRADA and subsequent related research conducted at LLNL. The cost to file and prosecute U.S. Licensed Patents will be as follows:
  12.1.1   Category 1 Patents: Costs will be shared by THE REGENTS and LICENSEE. LICENSEE will reimburse THE REGENTS $[ * ] for each Category 1 Patent that both Parties believe is necessary for the commercialization of Licensed Products. Payment will be made following the successful completion and testing of the sub-scale prototype (estimated to be [ * ]).
 
  12.1.2   Category 2 Patents: THE REGENTS will pay for the filing and prosecution of U.S. patents except that LICENSEE may be required to pay an additional fee for Category 2 Patents added to this License.
 
  12.1.3   Category 3 Patents LICENSEE is responsible for filing and prosecution costs of U.S. patents.
 
  12.1.4   For all Categories 1, 2, and 3 Patents, LICENSEE will pay for its share of foreign filing fees which may be the entire cost (in the event that LICENSEE is exclusively licensed all the rights hereunder) or a partial share if THE REGENTS has other licensees in other fields of use. The amount of such partial share will be apportioned based upon the number of other licensees for such foreign rights.

20


 

12.2   As the party solely responsible for the commercialization of the Invention, LICENSEE will pay all of the expenses associated with patent interferences, patent appeals to the USPTO Board of Appeals, patent appeals to a Federal Court, patent re-examinations, and patent re-issues, as long as the Licensed Patent remains on Exhibit A (LICENSED PATENTS), and such expenses shall be shared among all current licensees of the Licensed Patents.
12.3   LICENSEE may request foreign rights in Licensed Patents, if such rights are available. LICENSEE must request such rights in writing, 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, unless such foreign rights are still available and LICENSEE pays for such rights.
12.4   All costs of preparing, filing, prosecuting, and maintaining foreign patent applications and patents covering the Inventions listed in Exhibit A (LICENSED PATENTS) will be borne by LICENSEE, subject to the terms of this Agreement. All such patents will be held in the name of THE REGENTS and obtained using counsel selected by THE REGENTS. The costs of any interferences and oppositions for foreign patents will be considered prosecution expenses and also will be borne by LICENSEE. An advance fee (Fee) will be invoiced to LICENSEE by THE REGENTS for any future foreign filing of Licensed Patents listed in Exhibit A (LICENSED PATENTS). THE REGENTS is authorized to pay the incurred fees from the Fee. As evidence of expenses incurred, THE REGENTS will supply invoices for foreign filing requested by LICENSEE to LICENSEE. THE REGENTS shall credit to LICENSEE any remaining balance of the Fee not used for foreign filing expenses incurred. The Fee is not an advance against any other fees or royalties due THE REGENTS under this Agreement.
12.5   Notwithstanding anything to the contrary in this Article 12, in the event that other third parties are licensees of the Licensed Patents (for a field of use other than Field of Use) for which foreign rights are sought, THE REGENTS will use all reasonable efforts to share

21


 

all of the foreign filing costs and expenses described in this Article 12 between and amongst any other such licensees, and shall not license the Licensed Patents to any third party in any foreign jurisdiction for which LICENSEE has paid for such foreign rights without providing LICENSEE with credits for LICENSEE’s previously incurred expenses.
12.6   The preparation, filing, and prosecution of foreign patent applications, as well as the maintenance of the resulting patents, shall be at the expense of LICENSEE. THE REGENTS shall invoice LICENSEE for payment of costs for foreign patent application preparation, filing, prosecution, and maintenance. If such payment is not received within ninety (90) days, such foreign license rights shall be excluded from this license agreement, unless such foreign license rights are still available and LICENSEE pays for such rights. THE REGENTS shall not be liable in any manner for the loss of such foreign license rights arising due to LICENSEE’s failure to pay such fees on a timely manner. Any overpayments by LICENSEE for foreign patent filing and maintenance costs shall be credited towards LICENSEE’s future foreign patent cost obligations.
12.7   Notwithstanding any previous payment of fees or election to pursue such rights, LICENSEE may, at its sole discretion, terminate its license to any foreign patent application(s) or patent(s), and its obligation to pay any further costs for those corresponding foreign rights, upon thirty (30) days written notice to THE REGENTS. THE REGENTS or the U.S. Government may, at its sole discretion and expense, continue prosecution and/or maintenance of any patents or applications for which LICENSEE has relinquished rights.
12.8   LICENSEE will notify THE REGENTS of any change of its status as a small entity (as defined by the United States Patent and Trademark Office) and of the first sublicense granted to an entity that does not qualify as a small entity.
13.   PATENT INFRINGEMENT
13.1   In the event that THE REGENTS or LICENSEE learns of infringement that it believes may have potential commercial significance to any Licensed Patent, the knowledgeable

22


 

party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the “Infringement Notice”). During the period in which, and in the jurisdiction where, LICENSEE has exclusive rights under this Agreement, neither THE REGENTS nor LICENSEE will notify a third party (including the infringer) of infringement or put such third party on notice of the existence of any Patent Rights without first obtaining consent of the other. THE REGENTS shall have the right to terminate this Agreement immediately without the obligation to provide 60 days’ notice as set forth in Paragraph 10.1 if LICENSEE notifies a third party in writing of infringement or puts such third party on notice in writing of the existence of any Patent Rights with respect to such infringement without first obtaining the written consent of THE REGENTS. Both THE REGENTS and LICENSEE will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.
13.2   If infringing activity of potential commercial significance by the infringer has not been abated within ninety (90) days following the date the Infringement Notice takes effect, LICENSEE may institute suit for patent infringement against the infringer. THE REGENTS may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of LICENSEE’s suit or any judgment rendered in that suit. LICENSEE may not join THE REGENTS in a suit initiated by LICENSEE without THE REGENTS’ prior written consent, unless otherwise required to do so by law or by court order. If, in a suit initiated by LICENSEE, THE REGENTS is involuntarily joined, LICENSEE will pay any reasonable costs and expenses incurred by THE REGENTS arising out of such suit, including but not limited to, any legal fees of counsel that THE REGENTS selects and retains to represent it in the suit, provided, however, that THE REGENTS shall be obligated to coordinate any such retention and representation with the activities of LICENSEE in an effort to minimize such costs and expenses.
13.3   If, within a hundred and twenty (120) days following the date the Infringement Notice takes effect, infringing activity of potential commercial significance by the infringer has not been abated and if LICENSEE has not brought suit against the infringer, THE

23


 

REGENTS may institute suit for patent infringement against the infringer. If THE REGENTS institutes such suit, LICENSEE may not join such suit without THE REGENTS’ consent and may not thereafter commence suit against the infringer for the acts of infringement that are the subject of THE REGENTS’ suit or any judgment rendered in that suit.
13.4   Any recovery or settlement received in connection with any suit will first be allocated to cover the litigation costs incurred by THE REGENTS and LICENSEE and required to be paid under this Agreement. Any recovery in excess of litigation costs will be shared between LICENSEE and THE REGENTS as follows: (a) for any recovery other than amounts paid for willful infringement: (i) the initiating Party will receive one hundred percent (100%) of the recovery if the other Party was not a party in the litigation and did not incur any litigation costs, (ii) the initiating Party will receive seventy-five percent (75%) of the recovery and the other Party, twenty-five percent (25%), if the other Party was a party in the litigation, but did not incur any litigation costs, and (iii) each Party will receive fifty percent (50%) of the recovery if both Parties were active participants in the litigation and both Parties incurred material litigation costs in connection with the litigation (taking into account the entire expense of pursuing such litigation); and (b) for any recovery for willful infringement, each Party will receive fifty percent (50%) of the recovery. THE REGENTS and LICENSEE agree to be bound by all determinations of patent infringement, validity, and enforceability (but no other issue) resolved by any final, non-appealable adjudicated judgment in a suit brought in compliance with this Article 13. Notwithstanding anything else to the contrary herein, the amounts payable to THE REGENTS under this paragraph, after all litigation costs have been allocated, shall approximate amounts that would have been payable as earned royalties on the revenues lost as a result of the actions of the infringing party.
13.5   Any agreement made by LICENSEE for purposes of settling litigation or other dispute shall comply with the requirements of Article 4 (SUBLICENSING RIGHTS AND OBLIGATIONS) of this Agreement.

24


 

13.6   Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who initiated the suit (unless such suit is being jointly prosecuted by the parties).
 
13.7   Any litigation proceedings will be controlled by the party bringing the suit.
 
14.   USE OF NAMES AND TRADEMARKS
 
    Nothing contained in this Agreement will be construed as conferring any right to either Party to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of the other Party (including a contraction, abbreviation or simulation of any of the foregoing). Unless consented to in writing by THE REGENTS the use by LICENSEE of the name “Lawrence Livermore National Laboratory,” or “The Regents of the University of California,” or the name of any University of California campus by LICENSEE in advertising, publicity, or other promotional activities is expressly prohibited.
 
15.   LIMITED WARRANTY
 
15.1   THE REGENTS warrants to LICENSEE that it has the lawful right to grant this license.
 
15.2   Except as expressly set forth in this Agreement, the licenses and the associated Invention, Patent Rights, Licensed Products, Licensed Services, and Licensed Methods are provided by THE REGENTS WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. THE REGENTS MAKES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY THAT THE INVENTION, PATENT RIGHTS, LICENSED PRODUCTS, OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS.
 
15.3   Nothing in this Agreement is or will be construed as:
  15.3.1   a warranty or representation by THE REGENTS as to the validity, enforceability, or scope of any Patent Rights; or

25


 

  15.3.2   a warranty or representation that anything made, used, sold, or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of patents, copyrights, or other rights of third parties; or
  15.3.3   an obligation to bring or prosecute actions or suits against third parties for patent infringement except as provided in Article 13 (PATENT INFRINGEMENT); or
  15.3.4   conferring by implication, estoppel, or otherwise any license or rights under any patents or other rights of THE REGENTS other than Patent Rights, regardless of whether such patents are dominant or subordinate to Patent Rights; or
  15.3.5   an obligation to furnish any New Developments, know-how, technology, or technological information not provided in Patent Rights.
15.4   LIMITATION OF LIABILITY — THE REGENTS OR DOE WILL NOT BE LIABLE FOR ANY LOST PROFITS, COSTS OF PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT, OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR OTHER SPECIAL DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES, OR AFFILIATES ARISING OUT OF OR RELATED TO THIS AGREEMENT, FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF THE REGENTS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
 
16.   INDEMNIFICATION
 
    LICENSEE will, and will require its sublicensees to (to the extent permitted by Federal or applicable State law without the consent of a legislative body, an elected official, or governmental unit), indemnify, hold harmless, and defend THE REGENTS, DOE, their officers, employees, and agents; the sponsors of the research that led to the invention; and the inventors of any invention claimed in the patent under Patent Rights (including the Licensed Products, Licensed Services, and Licensed Methods contemplated thereunder) and their employers against any and all amounts paid pursuant to any claims, suits, losses,

26


 

damage, costs, fees, and expenses alleging that any Licensed Product or Licensed Service infringes the intellectual property of another party or has injured any other party. THE REGENTS will, and will require all other parties to be indemnified pursuant to this paragraph, immediately surrender to LICENSEE the prosecution or defense of any such claim or suit, and LICENSEE will pay any and all costs, including reasonable attorneys’ fees, incurred by THE REGENTS in enforcing this indemnification. This indemnification will include, but will not be limited to, any product liability.
17.   INSURANCE
17.1   LICENSEE will insure its activities relating to this Agreement at its own cost with an insurance company reasonably acceptable to THE REGENTS. LICENSEE will obtain, keep in force, and maintain insurance as follows with an insurance company reasonably 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:
  17.1.1   Each occurrence coverage of not less than Five Million Dollars ($5,000,000); and
 
  17.1.2   Product Liability Insurance: Completed operations aggregate coverage of not less than Ten Million Dollars ($10,000,000); and
 
  17.1.3   Personal and Advertising Injury: Coverage of not less than Five Million Dollars ($5,000,000); and
 
  17.1.4   General Aggregate (Commercial Form only): Coverage of not less than Ten Million Dollars ($10,000,000).
17.2   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.

27


 

17.3   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.
17.4   LICENSEE will maintain the general liability insurance specified in this Article 17 during the period that the Licensed Patents of THE REGENTS are being used and/or Licensed Products are being sold or otherwise commercially distributed by LICENSEE, and for a period of not less than three (3) years thereafter.
17.5   LICENSEE’s insurance coverage must:
  17.5.1   Provide for at least thirty (30) days advance written notice to THE REGENTS of cancellation or any modification; and
 
  17.5.2   Indicate that DOE, THE REGENTS, and their respective officers, employees, students, and agents, are endorsed on the policy as additional insureds; and
 
  17.5.3   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.
18.   WAIVER
18.1   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 waiving or consenting Party.
18.2   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 right, or operate to bar the enforcement or exercise of the right at any time thereafter.
19.   ASSIGNABILITY
19.1   This Agreement is binding on and inures to the benefit of THE REGENTS, its successors and assigns, but is personal to LICENSEE. Except as provided in Paragraph 19.2, any assignment of this Agreement for any reason including but not limited to merger or sale

28


 

of majority assets is at the sole discretion of THE REGENTS and requires prior written consent of THE REGENTS, which will not be unreasonably withheld. Except as provided in Paragraph 19.2, should THE REGENTS approve such assignment, LICENSEE will pay THE REGENTS an Assignment Fee as set forth in Exhibit C (FEES AND ROYALTIES) of this Agreement.
19.2   Notwithstanding Paragraph 19.1 above, an assignment to a wholly-owned United States subsidiary of LICENSEE will not require the consent of THE REGENTS or the payment of an Assignment Fee.
 
20.   LATE PAYMENTS
 
    In the event that royalty payments, fees, or other monies owed to THE REGENTS are not received by THE REGENTS when due, LICENSEE will pay to THE REGENTS interest at a rate of ten percent (10%) simple interest per annum. Such interest will be calculated from the date payment was due until actually received by THE REGENTS. Such accrual of interest will be in addition to, and not in lieu of, enforcement of any other rights of THE REGENTS due to such late payment. LICENSEE will pay any reasonable costs incurred by THE REGENTS in collecting late payments.
 
21.   NOTICES
 
21.1   Any notice or payment required to be given to either Party will be deemed to have been properly given and to be effective:
  21.1.1   on the date of delivery if delivered in person; or
 
  21.1.2   on the date of mailing if mailed by first-class certified mail, postage paid; or
 
  21.1.3   on the date of mailing if mailed by any global express carrier service that requires the recipient to sign the documents demonstrating the delivery of such notice of payment;
to the respective addresses given below, or to another address as designated in writing by the Party changing its address.

29


 

     
In the case of LICENSEE:
  TOMOTHERAPY INCORPORATED
 
  1240 Deming Way
 
  Madison, WI 53717
 
  Phone: (608)  ###-###-####
 
  Fax: (608)  ###-###-####
 
  Attention: Vice President and General Counsel
 
   
In the case of THE REGENTS:
   
 
   
All correspondence, original
   
progress reports, and royalty
   
reports:
  Lawrence Livermore National Laboratory
 
  Industrial Partnerships and Commercialization
 
  P.O. Box 808, L-795
 
  7000 East Avenue, L-795
 
  Livermore, CA 94550
 
  Attention: Director, IPAC
 
  Fax: (925)  ###-###-####
 
   
Payments and copies of
   
corresponding royalty reports:
  Lawrence Livermore National Laboratory
 
  P.O. Box 5517
 
  Livermore, CA 94551
22.   GOVERNING LAWS; VENUE; ATTORNEYS FEES
22.1   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.
 
22.2   THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, excluding any choice of law rules that would direct the application of the laws of another jurisdiction, but the scope and validity of any patent or patent application will be governed by the applicable laws of the country of such patent or patent application. Any legal action related to this Agreement will be conducted in the State of California.

30


 

23.   PATENT MARKING
 
    LICENSEE will mark 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.
 
24.   GOVERNMENT APPROVAL OR REGISTRATION
 
    If this Agreement or any associated transaction is required by the law of any nation to be either approved, permitted, or registered with any governmental agency, LICENSEE will assume all legal 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, unless otherwise specified in this Agreement.
 
25.   COMPLIANCE WITH LAWS
 
25.1   LICENSEE will comply with all applicable international, national, state, regional and local laws and regulations in performing its obligations hereunder and in its use, manufacture, Sale, or import of the Licensed Products, Licensed Services, or practice of the Licensed Method.
 
25.2   LICENSEE will comply with all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data and the provision of Licensed Services to foreign countries, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR).
 
25.3   LICENSEE will manufacture Licensed Products and practice the Licensed Method in compliance with applicable government importation laws and regulations of a particular country for Licensed Products made outside the particular country in which such Licensed Products are used or Sold.
         
    31    

 


 

25.4   THE REGENTS will provide reasonable assistance to LICENSEE, at LICENSEE’s expense, in completing any applications or seeking any approvals of the type described in this Article 25.
 
26.   FORCE MAJEURE
 
26.1   Except for LICENSEE’s obligation to make any payments to THE REGENTS hereunder, the Parties will not be responsible for any failure to perform due to the occurrence of any events beyond their reasonable control which render their performance impossible or onerous, including, but not limited to: accidents (environmental, toxic spill, etc.); acts of God; biological or nuclear incidents; casualties; earthquakes; fires; floods; governmental acts, orders or restrictions; inability to obtain suitable and sufficient labor, transportation, fuel and materials; local, national, or state emergency; power failure and power outages; acts of terrorism; strike; and war.
 
26.2   Either Party to this Agreement, however, will have the right to terminate this Agreement upon thirty (30) days’ prior written notice if either Party is unable to fulfill its obligations under this Agreement due to any of the causes mentioned in Paragraph 26.1, where such identified cause has prevented the performance of its obligations for a consecutive period of one (1) year.
 
26.3   In the event that an event described in Paragraph 26.1 occurs, the Parties agree that any time-sensitive obligations, including, without limitation, the Performance Obligations set forth in Exhibit E and the payment of minimum annual royalties set forth in Exhibit C, shall be tolled for a mutually agreed upon time, taking into account the nature of the occurrence, but in no event, for a time period shorter than the duration of the event giving rise to such tolling.
 
27.   UNITED STATES PREFERENCE
 
    LICENSEE agrees that any Licensed Products embodying the Invention or produced through the use thereof will be manufactured substantially in the United States.
         
    32    

 


 

28.   PROPRIETARY INFORMATION
 
    Other than as specified hereunder, the existence and terms of this Agreement shall be considered proprietary information. THE REGENTS shall not disclose the royalties paid, royalty reports, or development reports submitted by LICENSEE, or any of the information contained in those reports, without LICENSEE’s prior written consent. THE REGENTS may release to the inventors and senior administrators employed by THE REGENTS the terms of this Agreement upon their request. If such release is made, THE REGENTS will give notice of the proprietary nature of the terms and require that the recipient maintain the confidentiality. If a third party inquires whether a license to Licensed Patents is available, THE REGENTS may disclose the existence of this Agreement and the extent of the grant in Article 3 (LICENSE GRANT) to the third party, but will not disclose the name of LICENSEE or any other terms, except with LICENSEE’s consent or as required under a government audit, the California Public Records Act, the Freedom of Information Act, or other applicable law. THE REGENTS agree to provide written notice to LICENSEE of any disclosure made by THE REGENTS to a third party pursuant to this Article 28, including the identity of the third party and the information disclosed.
 
29.   MISCELLANEOUS
 
29.1   The headings of the several sections are inserted for convenience of reference only and are not intended to affect the meaning or interpretation of this Agreement.
 
29.2   No amendment or modification of this Agreement will be valid or binding upon the Parties unless made in writing and signed on behalf of each Party.
 
29.3   This Agreement with the attached Exhibits A, B, C, D and E embodies the entire understanding of the Parties and supersedes all previous communications, representations, or understandings, whether oral or written, between the Parties relating to the subject matter hereof.
 
29.4   If any of the provisions contained in this Agreement are held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality, or unenforceability will not affect
         
    33    

 


 

    any other provisions hereof, and this Agreement will be construed as if such invalid or illegal or unenforceable provisions had never been contained herein.
 
29.5   No provisions of this Agreement are intended or will be construed to confer upon or give to any person or entity other than THE REGENTS and LICENSEE any rights, remedies, or other benefits under, or by reason of, this Agreement.
 
29.6   In performing their respective duties under this Agreement, each of the Parties will be operating as an independent contractor. Nothing contained herein will in any way constitute any association, partnership, or joint venture between the Parties hereto, or be construed to evidence the intention of the Parties to establish any such relationship. Neither Party will have the power to bind the other Party or incur obligations on the other Party’s behalf without the other Party’s prior written consent.
In witness whereof, both THE REGENTS and LICENSEE have executed this Agreement, in duplicate originals, by their respective officers hereunto duly authorized, on the date and year hereinafter written.
             
TOMOTHERAPY INCORPORATED   THE REGENTS OF THE
UNIVERSITY OF CALIFORNIA
 
           
        LAWRENCE LIVERMORE
NATIONAL LABORATORY
 
           
By:
  /s/ Paul J. Reckwerdt   By:   /s/ George H. Miller
 
           
 
  (Signature)       (Signature)
Name:
  Paul J. Reckwerdt   Name:   George H. Miller
Title:
  President   Title:   Director, LLNL
 
Date signed: Feb 27, 2007   Date signed: Feb. 27, 2007
         
    34    

 


 

EXHIBIT A — LICENSED PATENTS
CATEGORY 1 PATENTS
UNITED STATES PATENTS:
                         
Invention                
Disclosure   Patent            
Number   Number   Title   Inventors   Filing Date   Issue Date
IL-9938
    6,331,194     Process for Manufacturing
Hollow Fused-Silica
Insulator Cylinder
  Stephen E. Sampayan,
Michael L. Krogh,
Steven C. Davis
Non-LLNL: Ben
Rosenblum
  07/08/97   12/18/01
 
                       
IL-10368
    7,173,385     Compact Accelerator   George J. Caporaso,
Stephen E. Sampayan,
Hugh C. Kirbie
  01/14/05   02/06/07
UNITED STATES PATENT APPLICATIONS:
                 
Invention   Patent            
Disclosure   Application            
Number   Number   Title   Inventors   Filing Date
IL-11372
  11/586,377   Single Pulse Traveling Wave
Accelerator
  George J. Caporaso, Scott
D. Nelson, Brian R. Poole
  10/24/06
 
               
IL-11425
  11/450,429   Bipolar Pulse Forming Line   Mark A. Rhodes   06/09/06
 
               
IL-11482
  11/586,468   Method of Controlling the Spatial Distribution of Large Electric Fields at Conductor Insulator Junctions   James S. Sullivan, George Caporaso, Stephen E. Sampayan, David M. Sanders   10/24/06
 
               
IL-11514
  11/599,797   Castable Dielectric Composite
Linear Wall Accelerator
  David M. Sanders,
Stephen E. Sampayan
Non-LLNL: H.M. Stoller,
Kirk Slenes
  11/14/06
 
               
[ * ]
  [ * ]   [ * ]   [ * ]   [ * ]

35


 

FOREIGN PATENT APPLICATIONS:
                 
Invention                
Disclosure   International            
Number   Serial Number   Title   Inventors   Filing Date
IL-10368
  PCT/US05/01548 [EP05722455.2]   Improved Compact Accelerator   George J. Caporaso,
Stephen E. Sampayan,
Hugh C. Kirbie
  01/18/05
 
               
IL-10368
  PCT/US05/01548
[JP]
  Improved Compact Accelerator   George J. Caporaso,
Stephen E. Sampayan,
Hugh C. Kirbie
  01/18/05
 
               
IL-10368
  PCT/US05/01548
[CA]
  Improved Compact Accelerator   George J. Caporaso,
Stephen E. Sampayan,
Hugh C. Kirbie
  01/18/05
 
               
IL-11372
  PCT/US06/4154   Sequentially Pulsed Traveling Wave
Accelerator
  George J. Caporaso,
Scott D. Nelson
  10/24/06
 
               
IL-11482
  PCT/US06/41814   Optically-Initiated Silicon Carbide
High Voltage Switch
  James Sullivan,
George Caporaso,
Stephen E. Sampayan,
David Sanders
  10/24/06
 
               
IL-11514
  PCT/US06/44297   Castable Dielectric Wall
Accelerator
  David M. Sanders,
Stephen E. Sampayan
Non-LLNL: H.M. Stoller,
Kirk Slenes
  11/14/06
The following Records of Inventions (ROIs) are to be included as Category 1 Patents upon filing of the associated patent application with the USPTO.
INVENTION DISCLOSURES
[ * ]


 

CATEGORY 2 PATENTS
NONE CURRENTLY
CATEGORY 3 PATENTS
NONE CURRENTLY

37


 

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
  Subject to the limitations set forth in this Agreement, THE REGENTS hereby grants to LICENSEE an exclusive, nontransferable (other than in accordance with the terms and conditions contained herein), royalty-bearing, license under Patent Rights (a) to make, use, Sell, offer for Sale, and import or export, subject to compliance with Article 25, Licensed Products and Licensed Services in the Field of Use; and (b) to practice Licensed Methods in the Field of Use.
 
   
B.1.2
  “Field of Use” means Particle and Radiotherapy
         
 
  B.1.2.1   To maintain exclusivity in the Particle therapy field of use, LICENSEE will have to submit a commercialization plan for each particle therapy application (e.g., carbon-12, heavy ion particle, etc.) even if the plan simply involves sublicensing. The first of these commercialization plans beyond proton therapy will be required [ * ] years after First Commercial Acceptance, so as not to distract the development of the proton therapy system. If LICENSEE fails to submit a commercialization plan for any particle therapy application within the required [ * ] years after First Commercial Acceptance, the Field of Use would be reduced to Proton and Radiotherapy.
 
       
 
  B.1.2.2   LICENSEE will have an option to negotiate to expand the Field of Use to include Isotope Generation, provided that LICENSEE submits a separate commercialization plan within the same time required for it to maintain exclusivity in particle therapies other than proton therapy, as specified in Paragraph B.1.2.1.

38


 

         
 
  B.1.2.3   THE REGENTS will ensure that so long as LICENSEE retains exclusive rights in the Particle and Radiotherapy Field of Use, no other sponsored research agreement, license, or any other type of agreement or arrangement in the future shall encumber Category 1 Patents, Category 2 Patents, and Category 3 Patents in the Particle and Radiotherapy Field of Use.
     
B.2
  Sublicensing Rights
 
   
 
  THE REGENTS also grants to LICENSEE the right to issue sublicenses of the rights granted to it in Paragraph B.1.1 above to Affiliates, Joint Ventures, and third parties (“sublicensees”) in the Field of Use, having rights no greater than those granted to LICENSEE, provided that, at the time of sublicensing, LICENSEE retains exclusive rights in the Field of Use for the Licensed Patents, Licensed Services, or Licensed Methods that are the subject of such sublicense. For the avoidance of doubt, Affiliates and Joint Ventures shall have no licenses under the Patent Rights unless such Affiliates and Joint Ventures are granted a sublicense.
 
   
B.3
  Rights Excluded
 
   
 
  Rights that are not specifically granted elsewhere in this Agreement are specifically excluded from the License.
 
   
B.4
  Future Rights
 
   
B.4.1
  LICENSEE may make a written request to THE REGENTS to add some Category 2 Patents to this License, and THE REGENTS agrees to amend Exhibit A of this License accordingly provided that LICENSEE pays any additional fees if required, as provided in Paragraph 12.1.2 of this Agreement.
 
   
B.4.2
  LICENSEE may make a written request to THE REGENTS to add Category 3 Patents to this Agreement for no additional license fees, except that LICENSEE will be required to pay patenting costs in accordance with Article 12 of this License. To the extent that copyrightable material maybe needed to successfully commercialize the Invention, such copyrights will be included in Exhibit A.

39


 

     
B.4.3
  Pursuant to B.1 .2.2, if LICENSEE submits a commercialization plan for the Field of Use of Isotope Generation within [ * ] years after First Commercial Acceptance, the future rights to the Field of Use of Isotope Generation would be included in this Agreement.
 
   
B.4.4
  At the conclusion of the CRADA, either through termination or six (6) months after completion, LICENSEE will have the opportunity to review all inventions generated during the course of the CRADA, to decide which inventions are needed to commercialize the Invention, and to amend Exhibit A to include such inventions, at which time all the future rights identified in this Section B.4 would have been listed in Exhibit A. Other Future Rights beyond those discussed herein must be negotiated in a separate Agreement.
 
   
B.5
  Performance Obligations
 
   
B.5.1
  LICENSEE will develop with THE REGENTS by the completion of the DWA subscale prototype (estimated to be [ * ], a more detailed schedule (Exhibit E “SCHEDULE”) that provides dates for each of the following obligations. To maintain exclusivity, specific dates must be mutually agreed to by THE REGENTS and LICENSEE by the later of (a) [ * ] or that date when the DWA subscale prototype is completed (“DWA Subscale Completion”). This Agreement must be amended with the SCHEDULE within sixty (60) days of the DWA Subscale Completion. It is expected that the SCHEDULE will be updated at least once annually using a form provided in the SCHEDULE during the course of the CRADA as new information is developed. Both parties signing the updated SCHEDULE form will be considered an amendment to the SCHEDULE.
         
 
  B.5.1.1   A [ * ] milestone that is related to the full-scale development of the DWA
 
       
 
  B.5.1.2   A [ * ] milestone that is related to the full-scale development of the DWA
 
       
 
  B.5.1.3   The estimated time after the successful testing of the full-scale DWA when the first therapy system incorporating the DWA will be installed at a location to be determined by the Parties.

40


 

         
 
  B.5.1.4   The date when LICENSEE will submit the required Federal Drug Administration (“FDA”) notification/application
 
       
 
  B.5.1.5   The date when LICENSEE will achieve First Commercial Acceptance, estimated to be one year after FDA approval
 
       
 
  B.5.1.6   A mutually-agreed process to jointly amend the SCHEDULE
     
B.5.2
  LICENSEE will hire or contract with the people it believes to be reasonably necessary to commercialize the DWA technology within sixty (60) days of the DWA Subscale Completion.
 
   
B.5.3
  LICENSEE will negotiate in good faith with the University of California Davis Health System (“UCDHS”) and Lawrence Livermore National Laboratory (“LLNL”) for a period not to exceed six (6) months after the Effective Date, regarding the timing, budget for, specifications, and location of the space required to house the prototype therapy system incorporating the DWA. On or before the closure of the six-month negotiation period following the Effective Date, UCDHS shall determine whether the prototype therapy system will be housed at UCDHS. Notwithstanding anything else to the contrary in this Agreement, failure to reach agreement within the six (6) month period shall not affect this Agreement in any way, except that LICENSEE shall work in good faith with THE REGENTS to locate the first prototype therapy system at another facility.
 
   
B.5.4
  LICENSEE will achieve cumulative commercial acceptances of [ * ] units of proton therapy systems three years after First Commercial Acceptance, subject to Paragraph 5.6 below.
 
   
B.5.5
  Other performance obligations for applications beyond proton therapy based on LICENSEE’s commercialization plan pursuant to Paragraphs B.1.2.1 and B.1.2.2.
 
   
B.5.6
  The sales 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 reasons specified in reasonable detail in such written request. THE REGENTS shall not unreasonably withhold, condition, or

41


 

     
 
  delay their consent to an amendment or extension provided that LICENSEE can provide a good business reason for the delay. Any delay beyond the reasonable control of LICENSEE will be deemed reasonable cause for amendment or extension of a Performance Obligation. Any delay resulting in an extension of the First Commercial Acceptance shall be accompanied by a corresponding extension of payments required of LICENSEE, including payments for milestones, earned royalties, and minimum royalties.
 
   
B.5.7
  Pursuant to Paragraph 7.1, the first progress report will be due on February 28, 2008.
 
   
B.5.8
  LICENSEE will proceed commercially 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.
 
   
B.5.9
  LICENSEE will submit a commercialization plan for applications beyond proton therapy, as provided in Paragraphs B.1.2.1 and B.1.2.2.

42


 

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 $[ * ] (License Issue Fee), to be paid when LICENSEE executes the Agreement, and pay Milestone Payments based on the following schedule of events:
  C.1.1.1   $[ * ], within thirty (30) days of the date on which the parties mutually agree they have completed a working sub-scale prototype of the DWA.
 
  C.1.1.2   $[ * ], within thirty (30) days of the date on which the parties mutually agree they have completed a working SiC or comparable switching prototype (which may be completed with the sub-scale prototype).
 
  C.1.1.3   $[ * ], within thirty (30) days of the date on which the parties mutually agree they have completed a working full-scale prototype of the DWA
C.1.2   THE REGENTS will execute the Agreement after receipt of LICENSEE’s executed copies of the Agreement and payment of the License Issue Fee.
C.1.3   The License Issue Fee and Milestone Payments will not be credited against any other royalty or fee due from LICENSEE to THE REGENTS.
C.2 Earned Royalties
C.2.1   Earned Royalties on Licensed Products. In addition to the License Issue Fee and Milestone Payments, LICENSEE will pay THE REGENTS an earned royalty of [ * ]% on Net Sales of Licensed Products. Payments of earned royalties will be in

43


 

    accordance with the requirements of Article 5 (FEES, ROYALTIES AND PAYMENTS) and Article 7 (PROGRESS AND ROYALTY REPORTS) of this Agreement.
C.2.2   Earned Royalties on Licensed Services. In addition to the License Issue Fee and Milestone Payments, LICENSEE will pay THE REGENTS an earned royalty of [ * ]% on Net Sales of Licensed Services. Payments of earned royalties will be in accordance with the requirements of Article 5 (FEES, ROYALTIES AND PAYMENTS) and Article 7 (PROGRESS AND ROYALTY REPORTS) of this Agreement.
C.2.3 Provisions for Earned Royalty Re-Evaluation
  C.2.3.1   Uncertainty of Clinical System Development Costs at UCDHS. In the event that LICENSEE’s sole combined costs (outside of funds contributed by THE REGENTS) to develop the full-scale DWA and the clinical system at UCDHS exceed $[ * ], the Parties agree to re-evaluate the Earned Royalty Rate provided in Paragraph C.2.1 and amend it as mutually agreed to by the Parties.
 
  C.2.3.2    Uncertainty of Production Costs of Licensed Products. In the event that the current earned royalties put the Licensed Products at a competitive disadvantage, the Parties agree to re-evaluate the Earned Royalty Rate provided in Paragraph C.2.1 and amend it as mutually agreed to by the Parties, taking into account the production costs, the commercial market of the DWA, and the likely price modifications necessary to make the Licensed Products more competitive in the marketplace.
C.2.4   In the event that LICENSEE grants sublicenses, LICENSEE will pay to THE REGENTS earned royalties from such sublicensing in accordance with the terms and conditions in this Agreement.
C.3 Minimum Annual Royalties
C.3.1   Subject to the terms and conditions of this Agreement, LICENSEE will pay to THE REGENTS a minimum annual royalty according to the requirements of Article 5 and the schedule below. The minimum annual royalty paid to THE REGENTS during a calendar

44


 

    year will be credited against the earned royalty due and owing for the calendar year in which the minimum payment was made.
         
Calendar year   Minimum annual royalty   Due date
2008
  $[ * ]   February 28, 2008
2009
  $[ * ]   February 28, 2009
2010
  $[ * ]   February 28, 2010
2011
  $[ * ]   February 28, 2011
2012
  $[ * ]   February 28, 2012
[ * ]
       
2013
  $[ * ]   February 28, 2013
2014
  $[ * ]   February 28, 2014
2015
  $[ * ]   February 28, 2015
2016
  $[ * ]   February 28, 2016
2017
  $[ * ]   February 28, 2017 and
every February 28 thereafter
for the life of this Agreement
C.3.2   The dates for First Commercial Acceptance and beyond, and the corresponding minimum annual royalties starting with $[ * ], may be modified pursuant to Exhibit E (SCHEDULE). If the First Commercial Acceptance is modified to a later year, then the minimum annual royalty for the original year that had the First Commercial Acceptance would be $[ * ] more than that of the year immediately preceding the original year that had the First Commercial Acceptance. For example, if the First Commercial Acceptance has been modified to [ * ], then the $[ * ] minimum annual royalty would start in [ * ], and [ * ] will have a minimum annual royalty of $[ * ] ($[ * ] more than the [ * ] minimum annual royalty).
C.4 Assignment Fee
    Except as provided in Paragraph 19.2, LICENSEE will pay THE REGENTS an Assignment Fee of $[ * ] as per Article 19 (ASSIGNABILITY) prior to such assignment being approved by THE REGENTS.

45


 

EXHIBIT D — MUTUAL NONDISCLOSURE AGREEMENT

46


 

MUTUAL NONDISCLOSURE AGREEMENT FOR EXCHANGE OF INFORMATION
WITH LAWRENCE LIVERMORE NATIONAL LABORATORY
This Agreement, effective on the date the last party signs, is made by and between TOMOTHERAPY, INC. located at 1240 Deming Way, Madison, WI ###-###-#### and THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, located at 1111 Franklin Street, Oakland, CA 94607 (“THE REGENTS”), under its Contract No. W-7405-ENG-48 with the U.S. DEPARTMENT OF ENERGY (“DOE”), as operators of the LAWRENCE LIVERMORE NATIONAL LABORATORY, located at 7000 East Avenue, Livermore, CA 94550 (“LLNL”).
WHEREAS, THE REGENTS, as operators of LLNL, and TOMOTHERAPY, INC. (hereinafter individually referred to as the “PARTY” or collectively as the “PARTIES”) wish to exchange certain confidential and proprietary information relating to LLNL’s Dielectric Wall Accelerator technology and research plans and TomoTherapy, Inc.’s radiotherapy technology, business, and commercialization plans (“PROPRIETARY INFORMATION”), this Agreement will govern the conditions of mutual disclosure of PROPRIETARY INFORMATION by the PARTIES.
The PARTIES hereby agree:
  (1)   To perform all terms of this Agreement and to maintain the PROPRIETARY INFORMATION in confidence, giving it the same degree of care, but no less than a reasonable degree of care, as the receiving PARTY exercises with its own proprietary information to prevent its unauthorized disclosure.
 
  (2)   To exchange and use the PROPRIETARY INFORMATION solely for the purpose of evaluation, testing, and development of potential collaborations, joint ventures, and/or license of the technology between the PARTIES.
 
  (3)   That neither PARTY, without the prior written consent of the other, will disclose any portion of the PROPRIETARY INFORMATION to others except to their employees, agents, consultants, subcontractors or Government personnel having a need to know in order to accomplish the sole purpose stated above, and who are bound by a like obligation of confidentiality under this Agreement.
 
  (4)   That neither PARTY will have any obligation, nor will the DOE, assume any liability with respect to any portion of the PROPRIETARY INFORMATION that:
  (a)   the receiving PARTIES can demonstrate by written record was previously known to them;
 
  (b)   is, or becomes, available to the public through no fault of the PARTIES;
 
  (c)   is lawfully obtained by the PARTIES from a third party who is not under an obligation of confidentiality with respect to the information disclosed; or
 
  (d)   is independently developed by or for the PARTIES independent of any disclosure hereunder, as demonstrated by written record, and such development was begun prior to any disclosure under this agreement.
  (5)   That PROPRIETARY INFORMATION disclosed by the PARTIES will be in writing and clearly marked “PROPRIETARY INFORMATION” or its equivalent. If such PROPRIETARY INFORMATION is initially disclosed orally or by demonstration, it will be identified as PROPRIETARY INFORMATION or its equivalent at the time of disclosure. The disclosing PARTY will, within thirty (30) days thereafter: (a) reduce such PROPRIETARY INFORMATION to writing or other tangible form, referencing the date and type of PROPRIETARY INFORMATION disclosed, and mark it as PROPRIETARY INFORMATION or its equivalent; and (b) deliver a copy to the receiving PARTY. All protections and restrictions as to use and disclosure will apply during such thirty (30) day period.
 
  (6)   That all rights and title to the PROPRIETARY INFORMATION disclosed under this Agreement will remain the property of disclosing PARTY unless otherwise agreed to in writing by the PARTIES.
 
  (7)   That PROPRIETARY INFORMATION provided by any disclosing PARTY to any receiving PARTY shall be returned to the disclosing PARTY within five (5) days of written request for such return by the disclosing PARTY.
 
  (8)   That no copies shall be made by a receiving PARTY of any PROPRIETARY INFORMATION without the express written consent of the disclosing PARTY. Any copies so authorized shall be returned to the disclosing PARTY or destroyed in accordance with the term and demand provisions of this Agreement.

 


 

  (9)   That the receiving PARTY agrees that with regard to any patent application provided as PROPRIETARY INFORMATION under this Agreement that no protest, public use proceeding, copied claims for provoking interference, or other action impeding issuance of any patent based on the disclosed application shall be filed by the receiving PARTY prior to issuance of such patent.
 
  (10)   The PARTIES agree that any photocopy or facsimile copy of this fully-executed Agreement shall have the same legal force and effect as any copy bearing original signatures of the PARTIES.
             
Technical Contact for Company:   Technical Contact for LLNL:
 
           
Name:
  T. Rockwell Mackie   Name:   George Caporaso
Company:
  TomoTherapy, Inc.   Company:   Lawrence Livermore National Laboratory
Address:
  1240 Deming Way   Address:   7000 East Avenue, L-645
 
  Madison, WI ###-###-####       P.O. Box 808
 
          Livermore, CA 94550
Phone:
  608 ###-###-####   Phone:   925 ###-###-####
Fax:
  608 ###-###-####   Fax:   925 ###-###-####
Email:
  ***@***   Email:    
It is further agreed that the furnishing of PROPRIETARY INFORMATION does not constitute any grant or license to the other PARTY for any legal rights now or hereinafter held by either PARTY.
This Agreement will be subject to, and interpreted in accordance with, the laws of the State of California,
Unless terminated earlier by thirty (30) days written notice by either PARTY to the other, this Agreement will remain in effect for two (2) year(s) from the effective date first written above, at which time the receiving PARTY will return or destroy the PROPRIETARY INFORMATION within thirty (30) days of the termination of this Agreement. If the PROPRIETARY INFORMATION is destroyed, a certificate of destruction must be furnished to the disclosing PARTY within the thirty (30) days. The secrecy and non-use obligations of the receiving PARTY set forth above will remain in effect for five (5) years from the effective date. Notwithstanding the forgoing, the secrecy and non-use obligations of the receiving PARTY set forth above will remain in effect indefinitely for any PROPRIETARY INFORMATION that is identified to the receiving party as a trade secret.
The receiving PARTY acknowledges its obligations to control access to technical data under the U.S. Export Laws and Regulations and agrees to adhere to such Laws and Regulations with regard to any technical data received under this Agreement;
Any modification to this Agreement must be in writing and signed by the duly authorized representative of each PARTY.
                 
        THE REGENTS OF THE UNIVERSITY OF CALIFORNIA,    
TOMOTHERAPY, INC.   LAWRENCE LIVERMORE NATIONAL LABORATORY    
 
               
Signature :
  /s/ Shawn D. Guse
 
  Signature:   /s/ Kathryn Rauhut
 
   
Type Name:
  Shawn D. Guse   Name:   Kathryn Rauhut    
Title: Vice President and General Counsel
  Title: Assistant Laboratory Counsel Office of Laboratory Counsel    
 
Date: January 11, 2006
  Date:   1/11/06    
RETURN TO:   Lawrence Livermore National Laboratory
ATTN: Terry Contreras
7000 East Avenue
P.O. Box 808, L-795
Livermore, CA 94551
     
cc: Genaro Mempin L-795; George Caporaso L-645    
PAT Directorate    

 


 

EXHIBIT E - SCHEDULE
NOTICE
LICENSEE considers information in this Exhibit E to be Proprietary.
Pursuant to Paragraph B.5.1 of Exhibit B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS), LICENSEE will develop with THE REGENTS by December 31, 2007, a more detailed schedule (“SCHEDULE”) that provides for the following, each of which shall be a Performance Obligation.
     
E.1
  Milestones
         
Reference   Milestone   Date
 
       
B.5.1.1
  A [ * ] milestone related to DWA full-scale development   [ * ]
 
       
B.5.1.2
  A [ * ] milestone related to DWA full-scale development   [ * ]
 
       
B.5.1.3
  Installation of the first therapy system incorporating the DWA at the location to be determined by both Parties   [ * ]
 
       
B.5.1.4
  Submission of required FDA notification/application   [ * ]
 
       
B.5.1.5
  First Commercial Acceptance   [ * ]
     
E.2
  Amendment Process (Reference B.5.1.6)
 
   
E.2.1
  Periodic reviews of the development of both the DWA and the proton therapy system will be conducted by Parties, who will jointly appoint the members of the reviewing body.
 
   
E.2.2
  Parties will review and update this schedule during the course of the CRADA at least once annually by September 30 and amend this Agreement accordingly.
 
   
E.2.3
  By the termination or completion of the CRADA, dates must be furnished, mutually agreed to, and entered into this License Schedule.

47