Document:

exv10w4

 

Exhibit B

Exhibit 10.4

Agreement No. 98-0228

LICENSE
AGREEMENT

     This Agreement is made effective the 22nd day of February 1999, by and between Wisconsin Alumni
Research Foundation (hereinafter called “WARF”), a nonstock, nonprofit Wisconsin corporation, and
TomoTherapy Incorporated (hereinafter called “TomoTherapy”), a corporation organized and existing
under the laws of Wisconsin;

     WHEREAS, WARF owns certain inventions that are described in the “Licensed Patents” defined below
and WARF previously granted a license to TomoTherapy under the Licensed Patents in an agreement,
Agreement No. 98-0025, between the parties dated March 1, 1998 (the “Prior License Agreement”); and

     WHEREAS, WARF and TomoTherapy desire to supersede the Prior License Agreement as set forth herein.

     NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the
parties covenant and agree as follows:

     Section 1. Definitions.

     For the purpose of this Agreement, the Appendix A definitions shall apply.

     Section 2. Grant.

          A. License.

     WARF hereby grants to TomoTherapy an exclusive license, limited to the Licensed Field, under the
Licensed Patents to make, have made, use, sell and otherwise distribute Products anywhere in the
world. Such license shall be exclusive except for the rights granted
to Nomos Corporation (“Nomos”) prior to the date of this
Agreement. WARF will not broaden or renew rights to Nomos outside those
previously rights granted to Nomos under the license agreement existing as of the date of this
Agreement.

          B. Sublicenses.

               (i) TomoTherapy may grant written, nonexclusive sublicenses to third parties. Any agreement
granting a sublicense shall state that the sublicense is subject to the termination of this
Agreement and TomoTherapy shall incorporate relevant terms of this Agreement in the sublicense.
TomoTherapy shall have the same responsibility for the activities of any sublicensee as if the
activities were directly those of TomoTherapy.

               (ii) In respect to sublicenses granted by TomoTherapy under this Section 2B, TomoTherapy shall pay
to WARF [  *  ] percent
([  *  ]%) of all fees, royalties and other payments received from such
sublicense(s) in the manner specified in Section 3F. At a minimum, TomoTherapy shall require its
sublicensee(s) to pay an upfront license fee of
$[  *  ] patent reimbursement of $[  *  ] and
minimum royalties of at least $[  *  ] per year beginning three years from the date of the
sublicense. In addition, TomoTherapy shall require sublicensees to pay royalties at a rate equal to
or exceeding the rate set forth in Section 3D. TomoTherapy shall provide WARF with a copy of all
sublicense agreements to

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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.

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allow WARF to verify the proper revenue sharing arrangement under such sublicense. WARF shall keep
all such information confidential as provided under Section 14. TomoTherapy shall not receive from
sublicensees anything of value in lieu of cash payments in consideration for any sublicense under
this Agreement without the express prior written permission of WARF. Any strategic partners of
TomoTherapy who are not granted a right to make or have made and sell Products under the Licensed
Patents shall not be considered a sublicensee under this Agreement and shall not be subject to
income sharing under this Section 2B. Strategic partners of TomoTherapy who, in addition to funding
Product development, are granted a right to make or have made and sell Products shall be considered
sublicensees under this Section 2B and shall be subject to minimum fee and royalty requirements as
set forth herein; however, WARF shall not share in any fees for services provided by TomoTherapy or
in any funding which TomoTherapy represents in good faith is not consideration for sublicense
rights granted to such strategic partner.

               (iii) Agreements with third parties which permit such third party to purchase Products from
TomoTherapy and resell such Products shall be considered distribution agreements and not sublicense
agreements subject to this Section 2B. Under any such distribution agreement, TomoTherapy shall pay
royalties to WARF on the sale of Products to such third party in accordance with Section 3D and
such agreements shall not be subject to the fee and royalty requirements of Section 2B(ii).

     Section
3. Consideration.

          A. Development.

     TomoTherapy agrees to and warrants that: it has, or will obtain, the expertise necessary to
independently evaluate the inventions of the Licensed Patents; it will establish and actively and
diligently pursue the development plan (see Appendix E) to the
end that the inventions of the
Licensed Patents will be utilized to provide Products for sale in the retail market; and within one
month following the end of each calendar quarter ending on March 31, June 30, September 30 and
December 31 and until the date of first commercial sale of Products, it will supply WARF with a
written Development Report. All development activities and strategies and all aspects of Products
design and decisions to market and the like are entirely at the discretion of TomoTherapy, and
TomoTherapy shall rely entirely on its own expertise with respect thereto. WARF’s review of
TomoTherapy’s development plan is solely to verify the existence of TomoTherapy’s commitment to
development activity and to assure compliance with TomoTherapy’s obligations to utilize the
inventions of the Licensed Patents for the marketplace, as set forth above.

          B. License Fee.

     TomoTherapy
agrees to pay to WARF a license fee of
$[  *  ] of which
$[  *  ] was paid under the
terms of the Prior License Agreement leaving a balance of
$[  *  ] due to WARF hereunder. In lieu
of a cash payment of these license fees, TomoTherapy agrees to issue to WARF and WARF agrees to
accept shares of TomoTherapy’s Common Stock under the terms the Equity Agreement between WARF and
TomoTherapy of even date herewith.

          C. Patent Reimbursement.

     TomoTherapy
agrees to reimburse WARF for [  *  ]% of the actual costs WARF incurs in
filing, prosecuting and maintaining the Licensed Patents. In lieu of a cash payment of patent
reimbursement due hereunder, TomoTherapy agrees to issue and WARF agrees to accept shares of
TomoTherapy Common Stock under the terms of the Equity Agreement referred to above, as a one time,
full and final payment of TomoTherapy’s obligations under this Section 3C to pay a portion of
WARF’s

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patent
costs. Such shares are included in the
[  *  ]% total of equity securities
TomoTherapy agrees to issue WARF under Section 2A of the Equity Agreement. WARF shall have sole
discretion to make or maintain any patent filing of the Licensed Patents. However, if WARF fails to
maintain the Licensed Patents, TomoTherapy may elect to maintain them in WARF’s name at
TomoTherapy’s own expense. In such case, TomoTherapy may credit
[  *  ]% of such patent
expense against royalties due under Section 3D.

          D. Royalty.

               (i) In addition to the Section 3B license fee, TomoTherapy agrees to pay to WARF as “earned
royalties” a royalty per Product Unit sold or leased by TomoTherapy at a rate determined in
accordance with the following table based on the cumulative number of Product Units sold or leased
by TomoTherapy before and including the sale or lease of the applicable Product Unit:

	 	 	 	 	 
	Cumulative Product Units Sold	 	Royalty Per
	or Leased	 	Product Unit
	[  *  ]
	 	 	
$[  *  ]	 
	[  *  ]
	 	 	$[  *  ]	 
	[  *  ]
	 	 	$[  *  ]	 

               (ii) A Product Unit is deemed sold or leased and a royalty is deemed earned under this
Agreement as of the date the Product Unit is actually sold and at least one third of the total
purchase price has been received by TomoTherapy in the case of a sale, or one third of the annual
lease payments for the first year of a lease have been so received by TomoTherapy.

               (iii) WARF is exempt from paying income taxes under U.S. law. Therefore, all payments due under
this Agreement shall be made without deduction for taxes, assessments, or other charges of any kind
which may be imposed on WARF by any government outside of the United States or any political
subdivision of such government with respect to any amounts payable to WARF pursuant to this
Agreement. All such taxes, assessments, or other charges shall be assumed by TomoTherapy.

          E. Minimum Royalty.

     TomoTherapy further agrees to pay to WARF a minimum royalty per calendar year or part thereof
during which this Agreement is in effect starting in calendar year 2000, against which any earned
royalty paid by TomoTherapy or WARF’s share of TomoTherapy’s sublicensee(s) payments for the same
calendar year will be credited. The minimum royalty shall be $[  *  ] in calendar year 2000, $[  *  ]
in 2001, $[  *  ] in 2002, and $[  *  ] in 2003 and each calendar year thereafter. The minimum
royalty for a given year shall be due at the time payments are due for the calendar quarter ending
on December 31. It is understood that the minimum royalties will apply on a calendar year basis,
and that sales of Products requiring the payment of earned royalties made during a prior or
subsequent calendar year shall have no effect on the annual minimum royalty due WARF for any given
calendar year.

          F.
Accounting; Payments.

               (i) Amounts owing to WARF under Section 3D shall be paid on a quarterly basis, with such
amounts due and received by WARF on or before the thirtieth day following the end of

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the calendar quarter ending on March 31, June 30, September 30 or December 31 in which such amounts
were earned. The balance of any amounts which remain unpaid more than thirty (30) days after they
are due to WARF shall accrue interest until paid at the rate of the lesser of one percent (1%) per
month or the maximum amount allowed under applicable law. However, in no event shall this
interest provision be construed as a grant of permission for any payment delays.

               (ii) Except as otherwise directed, all amounts owing to WARF under this Agreement shall be paid in
U.S. dollars to WARF at the address provided in Section 16(a). All royalties owing with respect to
selling prices stated in currencies other than U.S. dollars shall be converted at the rate shown in
the Federal Reserve Noon Valuation — Value of Foreign Currencies
on the day preceding the payment.

               (iii) A full accounting showing how any amounts owing to WARF under Section 3D have been calculated
shall be submitted to WARF on the date of each such payment. Such accounting shall be on a
per-country and product line, model or tradename basis and shall be summarized on the form shown in
Appendix C of this Agreement. In the event no payment is owed to WARF, a statement setting forth
that fact shall be supplied to WARF.

     Section 4. Certain Warranties of WARF.

          A. WARF warrants that except as otherwise provided under Section 13 of this Agreement with
respect to U.S. Government interests, it is the owner of the Licensed Patents or otherwise has the
right to grant the licenses granted to TomoTherapy in this Agreement. However, nothing in this
Agreement shall be construed as:

               (i) a warranty or representation by WARF as to the validity or scope of any of the Licensed
Patents;

               (ii) a warranty or representation that anything made, used, sold or otherwise disposed of under the
license granted in this Agreement will or will not infringe patents of third parties; or

               (iii) an obligation to furnish any know-how not provided in the Licensed Patents or any services
other than those specified in this Agreement.

          B. WARF MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH RESPECT TO USE, SALE, OR OTHER DISPOSITION
BY TOMOTHERAPY OR ITS VENDEES OR OTHER TRANSFEREES OF PRODUCTS INCORPORATING OR MADE BY USE OF
INVENTIONS LICENSED UNDER THIS AGREEMENT.

     Section 5. Recordkeeping.

          A. TomoTherapy shall keep books and records sufficient to verify the accuracy and
completeness of TomoTherapy’s accounting referred to above, including without limitation inventory,
purchase and invoice records relating to the Products or their manufacture. Such books and records
shall be preserved for a period not less than six (6) years after they are created during and after
the term of this Agreement.

          B. TomoTherapy shall take all steps necessary so that WARF may within sixty (60) days of
its request review and copy all the books and records at a single U.S. location to verify the
accuracy of TomoTherapy’s accounting. Such review may be performed by any employee of WARF as

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well as by any attorney or registered CPA designated by WARF at WARF’s expense, upon reasonable
notice and during regular business hours. TomoTherapy shall have the right to approve WARF’s
outside auditors and to reject them for bona fide conflicts of interest. TomoTherapy shall further
have the right to require audit participants to sign a reasonable non-disclosure agreement, but
such agreement may not compromise the auditor’s confidential communications of finding with WARF.

          C. If a royalty payment deficiency is determined, TomoTherapy shall pay the royalty
deficiency outstanding within forty-five (45) days of receiving written notice thereof, plus
interest on outstanding amounts as described in Section 3F(i). Should TomoTherapy contest the
royalty payment deficiency, TomoTherapy shall notify WARF of such contest within forty-five (45)
days of receiving notice and shall remit any uncontested amount plus interest within this same time
period. WARF’s acceptance of such payment shall not signify acceptance of this amount as a
settlement of the contested amount.

          D. If a royalty payment deficiency for a calendar year exceeds five percent (5%) of the
royalties paid for that year, then TomoTherapy shall be responsible
for paying WARF’s out-of-pocket
expenses incurred with respect to such review.

     Section 6. Term and Termination.

          A. The term of this license shall begin on the effective date of this Agreement and
continue until this Agreement is terminated as provided herein or until the earlier of the date
that no Licensed Patent remains an enforceable patent or the payment of earned royalties under
Section 3D, once begun, ceases for more than eight (8) consecutive calendar quarters.

          B. TomoTherapy may terminate this Agreement at any time by giving at least ninety (90)
days’ written and unambiguous notice of such termination to WARF. Such a notice shall be
accompanied by a statement of the reasons for termination.

          C. If TomoTherapy at any time defaults in the timely payment of any monies due to WARF or
the timely submission to WARF of any Development Report, fails to actively pursue the development
plan, or commits any breach of any other covenant herein contained, and TomoTherapy fails to remedy
any such breach or default within ninety (90) days after written notice thereof by WARF, or if
TomoTherapy commits any act of bankruptcy, becomes insolvent, is unable to pay its debts as they
become due, files a petition under any bankruptcy or insolvency act, or has any such petition filed
against it which is not dismissed within sixty (60) days, or offers any component of the Licensed
Patents to its creditors, WARF may, at its option, terminate this Agreement by giving notice of
termination to TomoTherapy.

          D. Upon the termination of this Agreement, TomoTherapy shall remain obligated to provide an
accounting for and to pay royalties earned up to the date of the termination and any minimum
royalties shall be prorated as of the date of termination by the number of days elapsed in the
applicable calendar year.

     Section 7.
Assignability.

     This Agreement may not be transferred or assigned by TomoTherapy except with the prior written
consent of WARF or except upon sale of substantially all the assets of TomoTherapy to a third
party. In such event, TomoTherapy shall ensure that the third party assignee has agreed to be bound
by all the obligations of this Agreement as part of such assignment and TomoTherapy shall provide
WARF with written notice, including the address and contact person, of the assignee.

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     Section 8. Contest of Validity.

     In the event TomoTherapy contests the validity of any Licensed Patent, TomoTherapy shall continue
to pay royalties with respect to that patent as if such contest were not underway until the patent
is adjudicated invalid or unenforceable by a court of last resort.

     Section 9. Enforcement and Defense of Patents.

          A. WARF intends to protect the Licensed Patents against infringers or otherwise act to eliminate
infringement, when, in WARF’s sole judgment, such action may be reasonably necessary, proper, and
justified. In the event that TomoTherapy believes there is infringement of any Licensed Patent
under this Agreement which is to TomoTherapy’s substantial detriment, TomoTherapy shall provide WARF
with written notice that such infringement is occurring including reasonable evidence of the
infringement. WARF shall have the right to determine the best course of action to resolve such
infringement, including but not limited to, the right to settle such infringement by negotiating a
license with such infringer. The license terms, fees and royalties shall be on terms no more
favorable in the aggregate to the Licensee than (those contained in the sublicense most favorable to
TomoTherapy granted by TomoTherapy. In the event that WARF licenses such infringer WARF shall share
the income from such license with TomoTherapy as set forth in this Section 9A. Upon request by
WARF, TomoTherapy shall take action, join in an action, and otherwise provide WARF with such
assistance and information as may be useful to WARF in connection with WARF’s taking such action
(if the cause of action arose during the term of this Agreement and WARF reimburses TomoTherapy for
TomoTherapy’s reasonable out-of-pocket expenses). Any recovery or damages for infringement or
license fees or royalties obtained through any settlement of infringement claims, except enhanced
damages, derived through WARF taking such action shall be applied as follows: (a) first, to WARF to
reimburse WARF for expenses incurred in litigation or negotiating a settlement, including
reasonable attorneys’ fees, (b) second, to TomoTherapy to reimburse TomoTherapy for its reasonable
expenses in assisting with same, including reasonable attorneys’ fees, and (c) the balance of any
recovery or damages shall be divided
[  *  ] percent
([  *  ]%) to TomoTherapy and
[  *  ] percent
([  *  ]%) to
WARF. If WARF does not take action to abate the infringement of the Licensed Patents within [  *  ] of receiving the notice described above, TomoTherapy may request that WARF do so and WARF
will comply as long as TomoTherapy reimburses WARF each month for
[  *  ] percent
([  *  ]%) of WARF’s
actual expenses incurred in bringing such action. Such expenses may be billed by WARF as frequently
as monthly and shall be paid by TomoTherapy to WARF on a net thirty (30) days basis. Late payments
shall be subject to the interest provisions set forth in Section 3F(i) for late payments.
TomoTherapy shall be reimbursed for its contribution to the cost of litigation or settlement from
the proceeds of such action as described in this Section 9A. TomoTherapy shall not have the right
to bring any infringement action or enforce the Licensed Patents without WARF’s prior, written
consent.

          B. In the event of a declaratory judgment action brought by a third party, WARF shall have
the exclusive right to defend the Licensed Patents by litigation or settlement, including the right
to grant licenses to third parties bringing such action. In the event that WARF licenses such third
party WARF shall share the income from such license with TomoTherapy as set forth in Section 9A.

          C. WARF agrees that if it determines to resolve any infringement or litigation by the grant
of a license to the infringer or third party litigant, it will first offer in writing to allow
TomoTherapy to negotiate a sublicense with such party. If TomoTherapy is not successful in
negotiating a sublicense agreement within six (6) months of such notification or if time becomes of
the essence in negotiating a license agreement to settle the infringement litigation, WARF may
directly negotiate and grant such a

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license to such third party and will share any revenue generated by such license with TomoTherapy
in accordance with Section 9A.

     Section 10. Patent Marking.

     TomoTherapy shall insure that it applies patent markings that meet all requirements of U.S. law, 35
U.S.C. 287, with respect to all Products subject to this Agreement.

     Section 11.
Product Liability; Conduct of Business.

     TomoTherapy shall, at all times during the term of this Agreement and thereafter, indemnify, defend
and hold WARF and the inventors of the Licensed Patents harmless against all claims and expenses,
including legal expenses and reasonable attorneys fees, arising out of the death of or injury to
any person or persons or out of any damage to property and against any other claim, proceeding,
demand, expense and liability of any kind whatsoever (other than patent infringement claims)
resulting from the production, manufacture, sale, use, lease, consumption or advertisement of
Products arising from any right or obligation of TomoTherapy hereunder. WARF at all times reserves
the right to select and retain counsel of its own to defend WARF’s interests.

     Section 12. Use of Names.

     TomoTherapy shall not use WARF’s name, the name of any inventor of inventions governed by this
Agreement, or the name of the University of Wisconsin in sales promotion, advertising, or any other
form of publicity without the prior written approval of the entity or person whose name is being
used.

     Section 13. United States Government Interests.

     It is understood that if the United States Government (through any of its agencies or otherwise)
has funded research, during the course of or under which any of the inventions of the Licensed
Patents were conceived or made, the United States Government is entitled, as a right, under the
provisions of 35 U.S.C. § 200-212 and applicable regulations of Chapter 37 of the Code of Federal
Regulations, to a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have
practiced the invention of such Licensed Patents for governmental purposes. Any license granted to
TomoTherapy in this Agreement shall be subject to such right.

     Section 14. Confidentiality.

     Both parties agree to keep all information marked confidential or otherwise subject to an
obligation of confidentiality under the terms of this Agreement confidential except to the extent
that:

     a. The receiving party can show by written record within sixty (60) days after disclosure
of the Information that it possessed such Information prior to its receipt from the other party;

     b. The information was already available to the public or became so through no fault of
the receiving party;

     c. The information is subsequently disclosed to the receiving party by a third party that
has the right to disclose it to the receiving party free of any obligations of confidentiality;

     d. Five years have elapsed from the later of the date of this Agreement or the disclosure
of the information to the receiving party by the other; or

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     e. Information the receiving party independently develops without reference to the confidential
information.

     Section 15. Miscellaneous.

     This Agreement shall be governed by and construed in all respects in accordance with the laws of
the State of Wisconsin. If any provisions of this Agreement are or shall come into conflict with
the laws or regulations of any jurisdiction or any governmental entity having jurisdiction over the
parties or this Agreement, those provisions shall be deemed automatically deleted, if such deletion
is allowed by relevant law, and the remaining terms and conditions of this Agreement shall remain
in full force and effect. If such a deletion is not so allowed or if such a deletion leaves terms
thereby made clearly illogical or inappropriate in effect, the parties agree to substitute new
terms as similar in effect to the present terms of this Agreement as may be allowed under the
applicable laws and regulations. The parties hereto are independent contractors and not joint
venturers or partners.

     Section 16. Notices.

     Any notice required to be given pursuant to the provisions of this Agreement shall be in writing
and shall be deemed to have been given at the earlier of the time when actually received as a
consequence of any effective method of delivery, including but not limited to hand delivery,
transmission by telecopier, or delivery by a professional courier service or the time when sent by
certified or registered mail addressed to the party for whom intended at the address below or at
such changed address as the party shall have specified by written notice, provided that any notice
of change of address shall be effective only upon actual receipt.

	 	(a)	 	Wisconsin Alumni Research Foundation

Attn: Managing Director

614 Walnut Street

Madison, Wisconsin 53705
	 
	 	(b)	 	TomoTherapy Incorporated

Attn: President

P.O. Box 8024

Madison, Wisconsin 53708-8024

     With a copy of such notice to:

Michael E. Skindrud, Esq.

LaFollette & Sinykin

P.O. Box 2719

One East Main Street

Madison, Wisconsin 53701-2719

     Section 16. Integration.

     This Agreement constitutes the full understanding between the parties with reference to the subject
matter hereof, and no statements or agreements by or between the parties, whether orally or in
writing, made prior to or at the signing hereof, shall vary or modify the written terms of this
Agreement. Neither party shall claim any amendment, modification, or release from any provisions of
this Agreement by mutual agreement, acknowledgment, or otherwise, unless such mutual agreement is
in writing, signed

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by the other party, and specifically states that it is an amendment to this Agreement. This
Agreement supersedes the Prior License Agreement in its entirety.

     Section 17. Authority.

          A. No agreement between the parties shall exist unless the duly authorized representative of
TomoTherapy and the managing director of WARF have signed this document within forty-five (45) days
of the effective date written on the first page of this Agreement.

          B. The persons signing on behalf of WARF and TomoTherapy hereby warrant and represent that
they have authority to execute this Agreement on behalf of the party for whom they have signed.

     IN
WITNESS WHEREOF, the parties hereto have duly executed this Agreement on the dates
indicated below.

	 	 	 	 	 	 	 
	  WISCONSIN ALUMNI RESEARCH FOUNDATION	 	 
	 
	 	 	 	 	 	 
	By:

	 	/s/ Richard H. Leazer
	 	 	 	Date: 2/24, 1999
	 

	 	 	 	 	 	 
	 

	 	Richard H. Leazer, Managing Director	 	 	 	 
	 
	 	 	 	 	 	 
	  TOMOTHERAPY INCORPORATED	 	 
	 
	 	 	 	 	 	 
	By:

	 	/s/ Paul J. Reckwerdt
	 	 	 	Date: 2/24, 1999
	 

	 	 	 	 	 	 
	 

	 	Paul J. Reckwerdt, Vice-President	 	 	 	 
	 
	 	 	 	 	 	 
	Reviewed by WARF’s Attorney:	 	 	 	 
	 
	 	 	 	 	 	 
	/s/ Elizabeth L.R. Donley	 	 	 	2/27, 1999
	 	 	 	 	 
	Elizabeth L.R. Donley, Esq.	 	 	 	 

(WARF’s attorney shall not be deemed a signatory to this Agreement.)

WARF Ref: Swerdloff-P91009US

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APPENDIX A

     A. “Licensed Patents” shall refer to and mean those patents and patent applications listed on
Appendix B hereto and any subsequent patent application owned by WARF but only to the extent it
claims an invention claimed in a patent application listed on Appendix B.

     B. “Products” shall refer to and mean any and all products that employ or are in any way
produced by the practice of an invention claimed in the Licensed Patents or that would otherwise
constitute infringement of any claims of the Licensed Patents.

     A. “Affiliates” shall mean and include affiliated companies or other legal entities at least
fifty percent (50%) of whose outstanding stock entitled to vote for election of directors is now
or hereafter owned or controlled by TomoTherapy either directly or through one or more affiliated
companies or both, but such company or other legal entity shall be deemed to be an affiliated
company only so long as such ownership or control exists.

     D. “Development Report” shall mean a written account of TomoTherapy’s progress under the
development plan having at least the information specified on Appendix D to this Agreement, and
shall be sent to the address specified on Appendix D.

     E. “Licensed Field” shall be limited to the field of medical applications of all types,
including without limitation, both human and animal diagnostics and therapeutic applications and
all research uses designed to lead to such applications. However, WARF retains the right to use and
to designate other research institutions, including but not limited to the University of
Wisconsin-Madison and the UW Hospitals and Clinics, to use the Licensed Patents for noncommercial
research purposes.

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APPENDIX B

LICENSED PATENTS

	 	 	 	 	 	 	 	 	 
	REFERENCE	 	 	 	PATENT	 	ISSUE	 	APPLICATION
	NUMBER	 	COUNTRY	 	NUMBER	 	DATE	 	SERIAL NUMBER
	 
	 	 	 	 	 	 	 	 	 
	METHOD AND APPARATUS FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 	 	 	 	 	 	 	 	 
	P91009US	 	UNITED STATES
	 	5,317,616.	 	5/31/94.	 	—
	P91009AU	 	AUSTRALIA
	 	661,640	 	12/12/95	 	 
	P91009BE	 	BELGIUM
	 	 	 	 	 	93301672.7
	P91009CA	 	CANADA
	 	 	 	 	 	2091275
	P91009DE	 	GERMANY
	 	 	 	 	 	 
	P91009FR	 	FRANCE
	 	 	 	 	 	93301672.7
	P91009GB	 	UNITED KINGDOM
	 	 	 	 	 	93301672.7
	P91009IL	 	ISRAEL
	 	104896	 	5/19/97	 	 
	P91009JP	 	JAPAN
	 	 	 	 	 	5-58983
	P91009KR	 	SOUTH KOREA
	 	 	 	 	 	4146/1993
	P91009MX	 	MEXICO
	 	 	 	 	 	931495
	P91009NL	 	NETHERLANDS
	 	 	 	 	 	93301672.7
	P91009NZ	 	NEW ZEALAND
	 	247042	 	6/4/96	 	 

P. O. BOX 7365     •     MADISON, WISCONSIN 53707-7365     •     TEL (608) 263-2500     •     FAX (608) 263-1064

Page 11 of 18

 

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	APPLICATION
	REFERENCE	 	 	 	PATENT	 	ISSUE	 	SERIAL
	NUMBER	 	COUNTRY	 	NUMBER	 	DATE	 	NUMBER
	 
	 	 	 	 	 	 	 	 	 
	RADIATION THERAPY SYSTEM WITH CONSTRAINED ROTATIONAL FREEDOM (Swerdloff, Mackie, Holmes)
	 	 	 
	 	 	 	 	 	 
	P92135DE	 	GERMANY
	 	—	 	—	 	94920124.8
	P92135FR	 	FRANCE
	 	 	 	 	 	94920124.8
	P92135GB	 	UNITED KINGDOM
	 	 	 	 	 	94920124.8
	P92135IL	 	ISRAEL
	 	 	 	 	 	109960
	P92135JP	 	JAPAN
	 	8-511452	 	12/03/96	 	 
	P92135NL	 	NETHERLANDS
	 	 	 	 	 	94920124.8
	 	 	 
	 	 	 	 	 	 
	RADIATION THERAPY SYSTEM (Swerdloff, Mackie, Holmes)
	 	 	 
	 	 	 	 	 	 
	P92136EP	 	EPO
	 	—	 	—	 	97113658.5
	 	 	 
	 	 	 	 	 	 
	DYNAMIC BEAM FLATTENING APPARATUS FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 	 	 
	 	 	 	 	 	 
	P92137DE	 	GERMANY
	 	—	 	—	 	94920125.5
	P92137FR	 	FRANCE
	 	 	 	 	 	94920125.5
	P92137GB	 	UNITED KINGDOM
	 	 	 	 	 	94920125.5
	P92137IL	 	ISRAEL
	 	 	 	 	 	109961
	P92137JP	 	JAPAN
	 	8-511453	 	12/03/96	 	 
	P92137NL	 	NETHERLANDS
	 	 	 	 	 	94920125.5

P. O. BOX 7365     •     MADISON, WISCONSIN 53707-7365     •     TEL (608) 263-2500     •     FAX (608) 263-1064

Page 12 of 18

 

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	APPLICATION
	REFERENCE	 	 	 	PATENT	 	ISSUE	 	SERIAL
	NUMBER	 	COUNTRY	 	NUMBER	 	DATE	 	NUMBER
	 
	 	 	 	 	 	 	 	 	 
	RADIATION THERAPY SYSTEM (Swerdloff, Mackie, Holmes)
	 	 	 
	 	 	 	 	 	 
	P92138EP	 	EPO
	 	—	 	—	 	97113657.7
	 	 	 
	 	 	 	 	 	 
	DYNAMIC COLLIMATOR FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes, Reckwerdt)
	 	 	 
	 	 	 	 	 	 
	P92138US	 	UNITED STATES
	 	5,442,675.	 	8/15/95.	 	—	 
	 	 	 
	 	 	 	 	 	 
	VERIFICATION SYSTEM FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 	 	 
	 	 	 	 	 	 
	P92140US	 	UNITED STATES
	 	5,394,452.	 	2/28/95.	 	—
	P92140IL	 	ISRAEL
	 	 	 	 	 	109962
	 	 	 
	 	 	 	 	 	 
	MULTI-LEAF RADIATION ATTENUATOR FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 	 	 
	 	 	 	 	 	 
	P92142US	 	UNITED STATES
	 	5,351,280.	 	9/27/94.	 	—
	P92142DE	 	GERMANY
	 	 	 	 	 	94920712.0
	P92142FR	 	FRANCE
	 	 	 	 	 	94920712.0
	P92142GB	 	UNITED KINGDOM
	 	 	 	 	 	94920712.0
	P92142IL	 	ISRAEL
	 	 	 	 	 	109962
	P92142JP	 	JAPAN
	 	8-511451	 	12/03/96	 	 
	P92142NL	 	NETHERLANDS
	 	 	 	 	 	94920712.0

P. O. BOX 7365     •     MADISON, WISCONSIN 53707-7365     •     TEL (608) 263-2500     •     FAX (608) 263-1064

Page 13 of 18

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	APPLICATION
	REFERENCE	 	 	 	PATENT	 	ISSUE	 	SERIAL
	NUMBER	 	COUNTRY	 	NUMBER	 	DATE	 	NUMBER
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	MULTI-LEAF RADIATION ATTENUATOR FOR RADIATION THERAPY WITH VERIFICATION SYSTEM (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P92143EP

	 	EPO
	 	 	—	 	 	—	 	 	97100108.6	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	MULTI-LEAF RADIATION ATTENUATOR FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P92144EP

	 	EPO	 	 	—	 	 	—	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	METHOD AND APPARATUS FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P94001US

	 	UNITED STATES
	 	 	5,528,650.	 	 	6/18/96.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	RADIATION TREATMENT PLANNING METHOD AND APPARATUS (Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P95083US

	 	UNITED STATES
	 	 	5,647,663.	 	 	7/15/97.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	METHOD OF REGISTERING A RADIATION TREATMENT PLAN TO A PATIENT (Reckwerdt, Mackie)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P95107US

	 	UNITED STATES
	 	 	5,673,300	 	 	9/30/97	 	 	 	 
	P95107CA

	 	CANADA
	 	 	—	 	 	—	 	 	2,207,539	 
	P95107EP

	 	EPO
	 	 	 	 	 	 	 	 	97303909.2	 
	P95107JP

	 	JAPAN
	 	 	 	 	 	 	 	 	09-167979	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	RADIATION THERAPY SYSTEM WITH CONSTRAINED ROTATIONAL FREEDOM (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P95141US

	 	UNITED STATES
	 	 	5,548,627.	 	 	8/20/96.	 	 	 	 

P.O.BOX 7365  •  MADISON, WISCONSIN 53707-7365  •  TEL (608) 263-2500  •  FAX (608) 263-1064

Page 14 of 18

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	APPLICATION
	REFERENCE	 	 	 	PATENT	 	ISSUE	 	SERIAL
	NUMBER	 	COUNTRY	 	NUMBER	 	DATE	 	NUMBER
	DYNAMIC BEAM FLATTENING APPARATUS FOR RADIATION THERAPY (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P95201US

	 	UNITED STATES
	 	 	5,625,663.	 	 	04/29/97.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	INTERFACE FOR RADIATION THERAPY MACHINE(SwerdIoff, Mackie, Holmes)
	P95202US

	 	UNITED STATES
	 	 	5,661,773	 	 	08/26/97	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	RADIATION THERAPY SYSTEM WITH CONSTRAINED ROTATIONAL FREEDOM (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P95254US

	 	UNITED STATES
	 	 	5,724,400.	 	 	03/03/98.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	METHOD AND
APPARATUS FOR CALIBRATION OF RADIATION THERAPY EQUIPMENT AND VERIFICATION OF RADIATION TREATMENT (Mackie, Reckwerdt, McNutt)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P98069US

	 	UNITED STATES	 	 	—	 	 	—	 	 	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	RADIATION THERAPY SYSTEM WITH CONSTRAINED ROTATIONAL FREEDOM AND DYNAMIC COLLIMATOR (Swerdloff, Mackie, Holmes)
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	P98167IL

	 	ISRAEL	 	 	 	 	 	—	 	 	 	 

P.O.BOX 7365  •  MADISON, WISCONSIN 53707-7365  •  TEL (608) 263-2500  •  FAX (608) 263-1064

Page 15 of 18

 

APPENDIX C

WARF ROYALTY REPORT

	 	 	 	 	 	 	 	 	 
	Licensee:

	 	 	 	 	 	Agreement No:	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Inventor:

	 	 	 	 	 	P#:
	 	P
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Period Covered:

	 	From:
	 	                    /                    /
	 	Through:
	 	                    /                    /
	 

	 	 	 	 
	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Prepared By:

	 	 	 	 	 	Date:	 	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Approved By:

	 	 	 	 	 	Date:	 	 
	 	 	 	 	 	 	 

If license covers several major product lines, please prepare a separate report

for each line. Then combine all product lines into a summary report.

	 	 	 	 	 
	Report Type:

	 	o
	 	Single Product Line Report:                                         
	 
	 	 	 	 
	 

	 	o
	 	Multiproduct Summary Report. Page 1 of                      Pages
	 
	 	 	 	 
	 

	 	o
	 	Product Line Detail. Line:                      Tradename:                      Page:                     
	 
	 	 	 	 
	Report Currency:

	 	o
	 	U.S. Dollars   o    Other                                                             

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Gross	 	 	Less	 	 	Net	 	 	Royalty	 	 	Period Royalty Amount	 
	Country	 	Sales	 	 	Allowances	 	 	Sales	 	 	Rate	 	 	This Year	 	 	Last Year	 
	 
	U.S.A.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Canada
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Europe:
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	Japan
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Other:
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	TOTAL:
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

Total
Royalty:                      Conversion Rate:                      Royalty in U.S. Dollars: $                     

The following royalty forecast is non-binding and for WARF’s internal planning purposes only:

     Royalty Forecast Under This Agreement: Next Quarter:                      Q2:                      Q3:              
        Q4:                     

* On a separate page, please indicate the reasons for returns or other adjustments if significant.

Also note any unusual occurrences that affected royalty amounts during this period.

To assist WARF’s forecasting, please comment on any significant expected trends in sales volume.

P.O.BOX 7365  •  MADISON, WISCONSIN 53707-7365  •  TEL (608) 263-2500  •  FAX (608) 263-1064

Page 16 of 18

 

APPENDIX D

DEVELOPMENT REPORT

	A.	 	Date development plan initiated and time period covered by this report.
	 
	B.	 	Development Report (4-8 paragraphs).

	 	1.	 	Activities completed since last report including the object and parameters of
the
development, when initiated, when completed and the results.
	 
	 	2.	 	Activities currently under investigation, i.e., ongoing activities including
object and parameters of such activities, when initiated, and projected date of completion.

	C.	 	Future Development Activities (4-8 paragraphs).

	 	1.	 	Activities to be undertaken before next report including, but not limited to,
the type and object of any studies conducted and their projected starting and completion dates.
	 
	 	2.	 	Estimated total development time remaining before a product will be commercialized.

	D.	 	Changes to initial development plan (2-4 paragraphs).

	 	1.	 	Reasons for change.
	 
	 	2.	 	Variables that may cause additional changes.

	E.	 	Items to be provided if applicable:

	 	1.	 	Information relating to Product that has become publicly available, e.g.,
published articles, competing products, patents, etc.
	 
	 	2.	 	Development work being performed by third parties other than TomoTherapy to
include name of third party, reasons for use of third party, planned future uses of third
parties including reasons why and type of work.
	 
	 	3.	 	Update of competitive information trends in industry, government compliance
(if applicable) and market plan.

PLEASE SEND DEVELOPMENT REPORTS TO:

Wisconsin Alumni Research Foundation

Attn.: Contract Coordinator

614 Walnut Street

P.O. Box 7365

Madison, WI 53707-7365

P.O.BOX 7365  •  MADISON, WISCONSIN 53707-7365  •  TEL (608) 263-2500  •  FAX (608) 263-1064

 Page  17 of 18 

 

APPENDIX E

DEVELOPMENT PLAN

     WARF hereby accepts the Business Plan submitted by TomoTherapy to WARF prior to the
execution of this Agreement as the development plan required hereunder.

P.O.BOX 7365  •  MADISON, WISCONSIN 53707-7365  •  TEL (608) 263-2500  •  FAX (608) 263-1064

 Page  18 of 18exv10w11

Table of Contents

Exhibit 10.11

DEVELOPMENT AND OEM SUPPLY AGREEMENT

TOMOTHERAPY

AGREEMENT entered into as of this 27th day of January 2003, by and between Analogic
Corporation (“ANALOGIC”), a Massachusetts corporation, having its principal place of business at 8
Centennial Drive, Peabody, Massachusetts and TomoTherapy Incorporated (“TOMOTHERAPY”), a Wisconsin
corporation, having its principal place of business at 1240 Deming Way Madison, Wisconsin (ANALOGIC
and TOMOTHERAPY hereinafter may be referred to individually as a “Party” and collectively as
“Parties”).

     WHEREAS TOMOTHERAPY has designed and is manufacturing an integrated radiation therapy
and imaging system (the “Product”);

     WHEREAS
ANALOGIC is a leading designer and manufacturer of systems and sub-systems used in,
among other things, computed tomography systems;

     WHEREAS TOMOTHERAPY wishes to engage ANALOGIC to design, manufacture, and/or supply those
systems and sub-systems shown in the Specifications (Exhibit 1) to be designed, manufactured,
and/or supplied by ANALOGIC (the “Components”) to be integrated into TOMOTHERAPY’s Product;

     WHEREAS ANALOGIC will lead and coordinate the development of the aforesaid Components;

     WHEREAS, the Parties intend that, upon the successful development of the Components,
ANALOGIC will be the exclusive manufacturer of the Components and TOMOTHERAPY will be the
exclusive seller of the Product.

     NOW, THEREFORE, in consideration of the above premises and the mutual obligations undertaken,
the parties hereto agree as follows:

1. DEVELOPMENT

	 	a.	 	Design: ANALOGIC shall design the Components in accordance with the Engineering
Requirement Specification (“SPECIFICATION”) attached as Exhibit 1, in accordance
with the Milestones attached as Exhibit 2.

 

 

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.

 

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Page 2

27 JANUARY 2002

	 	b.	 	Development Test Bed: ANALOGIC shall provide to TOMOTHERAPY one (1)
prototype of the Components. Each party shall perform all tests required of it
respectively, by the “Prototype Testing” section of the Development Plan as set forth in
the SPECIFICATION and the prototype will be suitable for regulatory testing.
	 
	 	c.	 	First (1st) Pilot Production Components: In accordance with Milestones
ANALOGIC shall produce and deliver to TOMOTHERAPY three (3) 1st pilot
production Components which meet the criteria specified in the SPECIFICATION.
Each party shall perform all tests required of it as set forth in the SPECIFICATION.
TOMOTHERAPY may request changes to the design of the 1st pilot production
Components in accordance with Section l(g), below. Certain components of the 1st
pilot production Components such as the BCS, DCS, RCS, DAS, and cabling will not
have been manufactured per the cGMP/QSR guidelines. The components of the
Components which do not meet these guidelines will have to be exchanged,
remanufactured, or brought into compliance by other means prior to shipment to an end
user. The methodology, documentation, and costs of how this will be accomplished
will be mutually agreed upon on a component by component basis.
	 
	 	d.	 	Second (2nd) Pilot Production Components: In accordance with Milestones and any
modifications or changes to the SPECIFICATION requested by TOMOTHERAPY and
agreed to by ANALOGIC, ANALOGIC shall produce and deliver to
TOMOTHERAPY six (6) 2nd pilot production units of the Components which
incorporate any such changes to the prototype or the 1st pilot production Components,
and meet the SPECIFICATION. ANALOGIC shall perform all tests required to meet
the SPECIFICATIONS. TOMOTHERAPY may request changes to the design of pilot
production Components in accordance with Section l(g), below. With the shipment of
any 2nd pilot production Components (assuming the design has been frozen and the
final documentation has been completed) and all future Components to
TOMOTHERAPY, ANALOGIC will provide to TOMOTHERAPY a technical file
which meets the requirements of cGMP/QSR and/or CE MDD.
	 
	 	e.	 	NRE: TOMOTHERAPY will pay ANALOGIC for the Non-Recurring Engineering
(“NRE”) in accordance with the agreed milestones attached as Exhibit 2.
	 
	 	f.	 	Manufacturing: The Components with the exception of 1.c will be manufactured by
ANALOGIC so as to qualify and validate all manufacturing processes in accordance
with the Good Manufacturing Practices and the Quality System Regulation
promulgated by the United States Food and Drug Administration (“FDA”) and
International Standards Organization’s ISO 9001.
	 
	 	 	 	For a period commencing with the shipment to a clinical user (in this Agreement,
“clinical user” includes TOMOTHERAPY’s Centers of
Excellence institutions) of the first pilot
production HI-ART II meeting SPECIFICATIONS and continuing for a period of four and one half
years thereafter, ANALOGIC will be the exclusive manufacturer of the Components, provided
however, that ANALOGIC’S manufacturing exclusivity for tables
only applies to the [  *  ] units ordered

 

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Page 3

27 JANUARY 2002

	 	 	 	by TOMOTHERAPY. After the first [  *  ]
tables are purchased by TOMOTHERAPY,
TOMOTHERAPY may procure or manufacture another table. However, it is understood by the Parties
that ANALOGIC owns all rights to its table design. Similarly, after the 4 and one half year
manufacturing exclusivity for the Components, TOMOTHERAPY may procure or manufacture the
Components of another design. It being understood by the Parties that ANALOGIC owns all rights
to its Components design.
	 
	 	g.	 	Engineering Changes: ANALOGIC shall transmit to TOMOTHERAPY for approval all proposed
Engineering Change Orders (ECO) that have, or could potentially have, an impact on the form,
fit, function, SPECIFICATIONS or regulatory approvals of the Components. Specifically in
regard to the impact on regulatory approvals, all ECO’s relating to those ANALOGIC Components
which are called out in TOMOTHERAPY’S standards construction file shall be transmitted to and
approved by TOMOTHERAPY. TOMOTHERAPY is responsible for insuring that ANALOGIC has an updated
list of relevant Components, which are listed, in TOMOTHERAPY’S standard construction file.
TOMOTHERAPY must respond within 48 hours after receiving all ECO information. ECO’s which do
not effect fit, form or function will not require approval by TOMOTHERAPY. TOMOTHERAPY will
not need to approve any ECO which is required by regulatory authority. These requirements
shall remain in effect throughout the production phase of this Agreement. If TOMOTHERAPY
desires to make a change to the SPECIFICATION for the Components at any time, it will make a
written request for change to ANALOGIC and ANALOGIC will respond in writing as to the
effect(s) of the change (“Change Implications”), if any, including without limitation, the
Components availability, Components price, and NRE. ANALOGIC will not be obliged to proceed
with making any requested changes unless the parties above first agree to the change
implications in writing. ANALOGIC will provide copies of all final Engineering Changes Orders
that are required by regulatory authority, that impact any ANALOGIC Component listed in the
standards construction file, or those requested by TOMOTHERAPY. These copies will include the
cover page and excerpts that sufficiently describe the change.
	 
	 	h.	 	Records; Regulatory Approval:

	 	i.	 	During the term of this Agreement, ANALOGIC shall keep detailed records of
all materials, processes, designs, protocols, and tests relevant to the Components and
all information required by the United States Food and Drug Administration (“FDA”) for
approval of the manufacturing and marketing of the Components that are not explicitly
the responsibility of TOMOTHERAPY under this Agreement. However, certain components of
the 1st pilot production as described in section l.c may not follow cGMP and
will be brought into compliance by an agreed method on a component by component basis.
ANALOGIC shall submit copies of such records to TOMOTHERAPY upon TOMOTHERAPY’S request.
TOMOTHERAPY will be responsible for filing

 

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Page 4

27 JANUARY 2002

	 	 	 	with the FDA and obtaining all other necessary regulatory approvals to market and sell
the System.
	 
	 	ii.	 	ANALOGIC hereby agrees to make available to TOMOTHERAPY all technical information within its
control with respect to the Components and ANALOGIC’s operations that is required by
regulatory clearances such as the United States Food and Drug Administration to obtain 510(k)
approval and required by a notified body to obtain the CE mark. TOMOTHERAPY shall treat all
such information as Confidential Information in accordance with Section 16 of this Agreement.
	 
	 	iii.	 	In the event that any component or any of the Components
designed or manufactured by ANALOGIC of the Product are recalled by TOMOTHERAPY or ANALOGIC solely as the
result of (A) ANALOGIC’s gross negligence or willful misconduct, (B) the recalled Component’s
failure to meet the SPECIFICATIONS, (C) ANALOGIC’s failure to comply with Quality System
Regulation, Good Manufacturing Practices, or ISO 9001,or (D) any other material
breach of this Agreement by ANALOGIC, ANALOGIC at its option shall either: provide replacement
parts to TOMOTHERAPY as soon as is reasonably possible or accept the return of the affected
units from TOMOTHERAPY for repair by ANALOGIC. The Parties will cooperate fully with each other
(including obtaining advance approval of all recall-related expenses to be paid by ANALOGIC,
which approval shall not be unreasonably withheld) in effecting any recall of the Components
and communicating with purchasers, users and the media. ANALOGIC shall not be responsible for
any recall related expenses arising from any other recall, including incompatibility of the
Components with any other part of the System unless such compatibility is required
in the Specifications. If any recall or other event requiring corrective action occurs for any
reason, than those set forth in the first sentence of this paragraph (iii)’s including due to
(AA) use of any TOMOTHERAPY products or software in combination with the Components (where the
combination itself gives rise to the recall and not the Components alone), (BB) modification of
the ANALOGIC software by any party (including TOMOTHERAPY) other than ANALOGIC, or (CC) any
other act or omission on TOMOTHERAPY’S part, then all costs and expenses associated with the
recall or other event, including the cost of replacement parts and/or return and repair of the
affected units, shall be borne solely by TOMOTHERAPY.
	 
	 	iv.	 	ANALOGIC will notify TOMOTHERAPY immediately of any Quality System Regulation audit of
ANALOGIC by the United States Food and Drug Administration or other inspection of ANALOGIC’s
records or its facilities by any federal, state regulatory agency as well as the results of
such audit or inspection.
	 
	 	v.	 	TOMOTHERAPY shall have the right to conduct an appropriate audit of ANALOGIC’s relevant
records and operations to evaluate compliance to the applicable sections of the cGMPs- QSR,
and ISO 9001. Such audits will be at a date acceptable to both ANALOGIC and TOMOTHERAPY and
will be

 

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Page 5

27 JANUARY 2002

conducted during ANALOGIC’s normal business hours. Within ten (10) days after
each such audit, TOMOTHERAPY will provide written notification of any non-compliance
issues. If ANALOGIC concurs with such conclusions (concurrence will not unreasonably
be withheld), it agrees to use commercially reasonable efforts to be in compliance
within 60 days following such written notification.

2. OWNERSHIP OF INTELLECTUAL PROPERTY

	 	a.	 	In performing the Development Work, ANALOGIC will utilize systems, sub-systems,
parts, software, know-how, and other intellectual and physical property that it owned
and/or had in its possession prior to the commencement of the Development Work (“ANALOGIC
Information”). Similarly, TOMOTHERAPY may utilize systems, subsystems, parts, software,
know-how, and other intellectual and physical property that it owned and/or had in its
possession prior to the commencement of the Development Work (“TOMOTHERAPY Information”).
With respect to ANALOGIC Information and TOMOTHERAPY Information, the Parties agree as
follows:

	 	i.	 	ANALOGIC owns the Proprietary Technology embedded
in the ANALOGIC Information and any improvements to it developed by
ANALOGIC during the course of the Development Work.
	 
	 	ii.	 	TOMOTHERAPY owns the Proprietary Technology embedded in the
TOMOTHERAPY Information and any improvements to it developed by TOMOTHERAPY
during the course of the Development Work.
	 
	 	iii.	 	To the extent that ANALOGIC develops Proprietary Technology
	 
	 	 	 	improvements to TOMOTHERAPY Information during the course of performing the
Development Work, and except as provided in Section 13.d. below, ANALOGIC owns
the improvements (but not the underlying TOMOTHERAPY Information) and grants
TOMOTHERAPY a license to use, modify, market and sublicense the ANALOGIC
improvements to the TOMOTHERAPY Information, and TOMOTHERAPY may assign the same
to a third party but only with ANALOGIC’s consent which consent will
not be unreasonably withheld, except that TOMOTHERAPY may assign the same
without ANALOGIC’s consent in connection with the assignment this Agreement
pursuant to Section 24 of this Agreement.
	 
	 	iv.	 	To the extent that TOMOTHERAPY develops Proprietary Technology
improvements to ANALOGIC Information during the course of performing the
Development Work, TOMOTHERAPY owns the improvements (but not the underlying
ANALOGIC Information) and grants ANALOGIC a license to use, modify, market and
sublicense the TOMOTHERAPY improvements to the ANALOGIC Information, and
ANALOGIC may

 

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	 	 	 	assign the same to a third party but only with TOMOTHERAPY’s consent which consent will
not be unreasonably withheld.
	 
	 	v.	 	Either Party may develop new Proprietary Technology during the course of the Development
Work that is embedded in the Components and that is not an improvement to the Information of
the-Party (as covered in subsections 2 a. iii and iv above) (“Development Information”). The
Party that created the Development Information owns the Development Information, and may use,
modify, market, sublicense, and transfer such Development Information for any purpose other
than for Radiation Therapy Delivery (as defined below), and may use, modify, market,
sublicense, and transfer the Development Information for Radiation Therapy Delivery only with
the written consent of the other Party, which consent may not be unreasonably withheld,
subject however to the rights of TOMOTHERAPY set forth in the final sentence of this
paragraph. The owner of the Development Information hereby grants to the other Party a license
to use, modify, market, and sublicense the Development Information, and may
transfer such license, for any purpose other than for Radiation Therapy Delivery (as defined
below), and such licensee may use, modify, market, sublicense, and transfer the license to the
Development Information for Radiation Therapy Delivery only with the written consent of the
other Party, which consent may not be unreasonably withheld, subject however to the rights of
TOMOTHERAPY set forth in the final sentence of this paragraph. For purposes of this Agreement,
“Radiation Therapy Delivery” means any system delivering external beam radiation in a medical
context, and does not include radiation therapy planning. Notwithstanding the foregoing,
TOMOTHERAPY may use, modify, market, and sublicense all Development Information in connection
with the development, manufacture and sale of its Product without the consent of ANALOGIC, and
may assign its own Development Information and its license to Development Information owned by
ANALOGIC without ANALOGIC’s consent in connection with the sale or transfer of substantially
all of its assets in a transaction to which the provisions of Section 24 of this Agreement
apply, provided that in conjunction with the sale or transfer of TOMOTHERAPY’S assets to a
third party, that the third party agrees to be bound by all of the terms of this Agreement, as
set forth in Section 24 of this Agreement for Analogic to manufacture and supply to the
receiver of the assets all of the Components which are the subject of this agreement
manufactured or supplied by ANALOGIC.
	 
	 	vi.	 	Development Information, that is jointly created by the Parties shall be treated as
separately owned by each Party, but each Party’s interest shall be subject to the rights and
restrictions imposed by the preceding paragraph v on separately owned=Development
Information,, without the obligation of the Parties to account to each other for or share with
the other party the proceeds arising from such jointly created Development Information.

 

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	 	vii.	 	Nothing herein is intended to give one Party any rights to the
Proprietary Technology of the other Party existing on the date of this
Agreement is entered into, except as is necessary to achieve the purposes of
this Agreement during the term of this Agreement and any mutually agreed upon
extensions to this Agreement.

	 	b.	 	While ANALOGIC owns the rights to the patient table pallet
design that is to
be delivered to TOMOTHERAPY pursuant to the Statement of Work and may
supply this exact table pallet to other customers, ANALOGIC acknowledges
and agrees that it will not knowingly supply this exact table pallet for use by
Third Parties in Radiation Therapy Delivery.
	 
	 	c.	 	TOMOTHERAPY acknowledges and agrees that ANALOGIC is an OEM supplier
of subassemblies, whole instruments and systems. It also acknowledges that it
understands ANALOGIC intends to continue to remain in this business and, subject
to any limitations imposed upon it hereunder, may even design and manufacture
products that contain some or all of the technology and designs used in the
Components, including, among other things, certain mechanics, circuitry and
software, proprietary to ANALOGIC. In addition, the Components may embody
certain patented features as well.

3. PURCHASE AND DELIVERY

ANALOGIC agrees to manufacture and sell the Components to TOMOTHERAPY, and TOMOTHERAPY
agrees to purchase its total number requirements of the Components exclusively from
ANALOGIC per section 1.f. and upon the following terms:

	 	a.	 	Upon TOMOTHERAPY’S acceptance of the pilot production Components, (which
acceptance shall be in accordance with the Components meeting the
SPECIFICATIONS), TOMOTHERAPY shall provide ANALOGIC with a rolling
twelve (12) month forecast of its purchase requirements for the Components, updated
on a monthly basis. The initial forecast will be accompanied by a firm purchase order
for the first six (6) months subject to the lead time defined below, and a projection of
orders for the following six (6) months. Three months thereafter, firm purchase orders
shall be furnished on the first week of each rolling month for Components to be
delivered in the third full calendar month following the month in which ANALOGIC
receives the purchase order. Projections of orders shall be for the parties’ planning
purposes only, and, except for a firm commitment to purchase Components for the next
three months, shall not constitute binding commitments upon TOMOTHERAPY.
TOMOTHERAPY may modify any purchase order up to ninety (90) days prior to the
beginning of the month covered by such purchase order. TOMOTHERAPY agrees
that for economic and production efficiency reasons ANALOGIC requires a consistent
and steady production flow (no production breaks month to month).
	 
	 	b.	 	ANALOGIC shall acknowledge promptly each TOMOTHERAPY purchase order in
writing and confirm delivery dates. Each order shall be subject to a lead-time of 120
days (“Lead Time”). TOMOTHERAPY acknowledges that some components used in

 

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	 	 	 	the manufacture of the Components may be designated by ANALOGIC as “Long-lead-time
Items” (“LLTI’s). ANALOGIC shall be authorized in writing by TOMOTHERAPY to place orders
for sufficient quantities of LLTI’s necessary to meet TOMOTHERAPY’S projected purchases set
forth on its forecasts. In the event that forecasted quantities of Components are not
actually ordered by TOMOTHERAPY, TOMOTHERAPY shall reimburse ANALOGIC for the LLTI’s unique
to TOMOTHERAPY’S Components purchased by ANALOGIC in connection with such forecasted
quantities which cannot be used elsewhere within ANALOGIC, or cancelled, or returned to the
vendor. The reimbursement value of such LLTI’s shall be
[  *  ]%.
	 
	 	c.	 	All sales of the Components shall be subject to the terms and conditions of this
Agreement. Except with respect to transaction-specific items such as quantities,
requested delivery dates, destinations and shipping instructions, purchase orders or
other similar documents issued by TOMOTHERAPY are for TOMOTHERAPY’S
administrative convenience only. No other terms or conditions contained in a purchase
order or such other similar document shall be of any force or effect. If there is any
conflict or difference in interpretation between such transaction specific items in a
TOMOTHERAPY purchase order and this Agreement, the terms and conditions of this
Agreement shall supersede those of such purchase order.
	 
	 	d.	 	Subject to the lead time requirements set forth herein, ANALOGIC shall be ready and
able to timely supply all quantities of Components ordered by TOMOTHERAPY that
are within its forecast and/or accepted by ANALOGIC. ANALOGIC shall not be liable
for failure or delay in filling TOMOTHERAPY orders because of any cause beyond the
control of or occurring without the fault of ANALOGIC.
	 
	 	e.	 	Should any parts or sub-components used by ANALOGIC in manufacturing the
Components either become unavailable for purchase and Analogic is advised thereof
by its supplier, or unavailable for a reasonable price, ANALOGIC shall give
TOMOTHERAPY notice thereof. Subject to such time limitations imposed on
ANALOGIC by the component manufacturer(s) or distributor(s), as the case may be,
during which ANALOGIC can acquire such components, TOMOTHERAPY may
exercise last time buy rights for the 

component(s) by authorizing ANALOGIC to place
purchase orders within the 30 days following such notice from ANALOGIC to
TOMOTHERAPY. The cost of the unique Components (components which are
purchased specifically for TOMOTHERAPY’S Product) which cannot be used
elsewhere within ANALOGIC purchased pursuant to the last time buy shall be paid for
in full by TOMOTHERAPY and maintained as dedicated inventory owned by
TOMOTHERAPY and TOMOTHERAPY will receive a corresponding credit when the
component is used in the Components by reducing the Components price
by [  *  ]%. Alternatively, Analogic may agree to
redesign the relevant component or components for a mutually agreed upon price.

4. PRICES, ADJUSTMENTS, AND PAYMENTS

	 	a.	 	The price to be paid by TOMOTHERAPY to ANALOGIC for the
Components is set forth on Exhibit 3 hereto. These initial
prices shall be valid for a period of two years

 

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	 	 	 	following shipment to a clinical user of the first production HI-ART II (system #11)
meeting SPECIFICATIONS. Thereafter, beginning on the second anniversary of the shipment to
a clinical user of the first production HI-ART II meeting SPECIFICATIONS, and every [  *  ] thereafter, the Parties shall review prices and quantities with the understanding
that prices may be adjusted by mutual agreement in response to the world market for
components, production yield, cost improvement, and other factors deemed relevant by the
parties. If parties cannot reach a mutual agreement, the parties will follow the
arbitration process outlined in section 23 hereafter. Unless otherwise specified or
required by law, all prices will be quoted and billed exclusive of federal, state or local
excise, sales or other similar taxes. Such taxes, when applicable, will appear as
additional items on invoices.
	 
	 	b.	 	ANALOGIC agrees that the price for the Components is at least as favorable to
TOMOTHERAPY as the price and the terms upon which ANALOGIC sells
comparable CT components to any other customer under similar circumstances.
	 
	 	c.	 	Terms of payment are net 30 days from of the date of delivery or invoice; whichever
is later, for shipments made.

5. SHIPMENTS OF PRODUCT

ANALOGIC shall ship the Products Ex Works (Incoterms 2000), ANALOGIC’s Peabody, MA plant via
carriers designated by TOMOTHERAPY.

6. TERM CHANGE

This Agreement will begin on the Effective Date and will continue for an initial term (“Initial
Term”) of four and one half (4.5) years from the shipment to a clinical user of the first pilot
production HI-ART II meeting SPECIFICATIONS, unless earlier terminated pursuant to Section 7 below.
If no notice of termination is given at least six (6) months prior to expiration of the Initial
Term, then this Agreement shall continue in effect until terminated by either party upon six (6)
months written notice thereafter.

7. TERMINATION

	 	a.	 	In the event of a substantial or material breach of any term or condition of this
Agreement by either party, which shall include, but not be limited to, non-payment of
invoices when due which breach is not or cannot be corrected by the breaching party within
thirty (30) days after notice (unless a longer time is expressly provided for herein), this
Agreement may be terminated by the other party by giving notice of termination, to take
effect forthwith upon the giving of such notice. Notwithstanding the foregoing,
TOMOTHERAPY may terminate this Agreement with respect to an unexcused ANALOGIC breach
related to failure to timely deliver Components only if ANALOGIC fails to deliver ordered
Components within sixty (60) days of the scheduled delivery date specified in any
TOMOTHERAPY purchase order that complies with TOMOTHERAPY’S forecast and has been accepted
by ANALOGLC. Additionally, a force majeure would be deemed an excused ANALOGIC breach.

 

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	 	b.	 	This Agreement may be terminated immediately by the either party without the
requirement of prior notice if the other party suspends operations, files or suffers to be
filed against it a petition in bankruptcy, or the like, executes an assignment for the
benefit of creditors, or is adjudicated as bankrupt by a court of competent jurisdiction.

8. PRODUCT CHANGES

ANALOGIC shall notify TOMOTHERAPY in writing of any change to the Components which do affect the
Component’s form, fit, function, SPECIFICATIONS or regulatory compliance. ANALOGIC shall not make
any change to the SPECIFICATIONS or to the Component’s labeling without TOMOTHERAPY’S prior written
consent, which consent will not be unreasonably withheld.

9. QUALITY CONTROL

	 	a.	 	ANALOGIC shall perform incoming inspection and testing on all materials it receives
from any source for inclusion in any of the Components in accordance with ANALOGIC’s
Corporate Quality Assurance Procedure Sampling Inspection/Testing by Attributes Procedure,
as amended from time to time in the normal course of business. In no case shall
non-conforming materials which affect the Component’s form, fit, or function be used in the
manufacture of the Components.
	 
	 	b.	 	The Components will be designed and manufactured by ANALOGIC in a manner that
will qualify and validate all manufacturing processes in accordance with current Good
Manufacturing Practices and the Quality System Regulations promulgated by the United States
Food and Drug Administration (“FDA”) and ISO 9001 and for
the Components after July 2002.
	 
	 	c.	 	All the Components shall meet the SPECIFICATIONS and shall be subjected to
ANALOGIC’s quality control systems and standards, which at all times will comply
with applicable regulatory requirements. ANALOGIC shall permit TOMOTHERAPY
to review periodically ANALOGIC’s relevant production and quality control
procedures and records and to visit ANALOGIC’s facilities at reasonable times with a
representative of ANALOGIC present.

10. OUTGOING INSPECTION AND PERFORMANCE INDICATORS

	 	a.	 	Beginning with the first pilot production Components, ANALOGIC will inspect all
outgoing Components to be supplied to TOMOTHERAPY to be strictly in
accordance with SPECIFICATIONS and perform outgoing acceptance testing.
TOMOTHERAPY will monitor the delivery and quality performance of ANALOGIC.
	 
	 	b.	 	An overview or SCAR (Supplier Corrective Action Request) will be generated by
TOMOTHERAPY on a quarterly basis or more frequently if necessary. The
performance indicators to be applied shall cover:

 

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% Complete and On-time delivery

Failures per unit (normalized over total quantity consumed monthly)

Failure symptoms, documentation deficiencies, packaging quality.

ANALOGIC will be responsible to provide a written quality report within fifteen (15)
days from receipt of TOMOTHERAPY’s SCAR quality report that contains corrective
actions to remedy failures.

ANALOGIC will be responsible to provide a written quarterly quality report to be issued by the
first Friday of each month that provides all key performance indicators as mutually agreed to with
TOMOTHERAPY.

11. SERVICE AND SPARE PARTS

	 	a.	 	ANALOGIC will provide Parts for a period of
seven (7) years following the last serial
delivery of the Components under this Agreement. The price of the Parts will be that
listed in Exhibit 4, SPARE PARTS PRICE LIST (Which will be determined by the
parties in good faith based on their prior practices, and otherwise based on industry
standards). In the event that a Part becomes obsolete, ANALOGIC will provide
TOMOTHERAPY notice as soon as ANALOGIC becomes aware of the anticipated
obsolescence and offer TOMOTHERAPY the opportunity to make a last buy. In the
event that ANALOGIC learns that a component used in manufacturing a Part of the
Components will become obsolete, it will notify TOMOTHERAPY and
TOMOTHERAPY may request ANALOGIC, at TOMOTHERAPY’s expense, to re-engineer the Part using components that are not obsolete.
	 
	 	b.	 	TOMOTHERAPY will provide ANALOGIC with Forecasts for Parts. On the 15th of
each month, TOMOTHERAPY will provide ANALOGIC a twelve (12) month
Forecast of its Parts needs. The first three (3) months of the Parts Forecast consists a
firm and binding commitment to purchase the Parts. ANALOGIC will not be
obligated to deliver parts in excess of thirty (30) percent above the second three (3)
months Parts Forecast.
	 
	 	d.	 	ANALOGIC will provide a quotation for Parts within five (5) business days if
TOMOTHERAPY seeks to purchase Parts not included in its Forecast and not in stock
at ANALOGIC.
	 
	 	e.	 	ANALOGIC will provide TOMOTHERAPY a list of all Parts that are Field
Replacement Units (“FRU”). This list will contain the following information: (1)
ANALOGIC part number; (2) ANALOGIC part description; (3) Price of new FRU;
(4) FRU lead-time and (5) List of repairable and non-repairable FRUs; (6) Price for
non-warranty repairable FRU’s.
	 
	 	f.	 	TOMOTHERAPY may return to ANALOGIC Parts, which are identified as repairable
for warranty and out-of-warranty repairs. ANALOGIC will repair the Parts described
in this sub-paragraph to the minimum allowable revision level within
a targeted thirty (30) to forty-five (45) working day period from
receipt of the returned Parts.

 

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	 	g.	 	ANALOGIC will provide repair services for the Components and Parts for a period of
seven years following the last serial delivery of the Components pursuant to this
Agreement.

12. WARRANTY AND REPAIRS

	 	a.	 	Except for Software, which is defined and provided for in Section 13, ANALOGIC
warrants to TOMOTHERAPY that all of the Components sold to TOMOTHERAPY
under this Agreement will be at the time of their delivery, free from defects in
workmanship and material and in compliance with the Specifications. ANALOGIC
further warrants that all of the Components sold to TOMOTHERAPY under this
Agreement will, on the date of shipment by ANALOGIC, have been manufactured by
ANALOGIC in accordance with the FDA’s current Good Manufacturing Practices,
Quality System Regulations, ISO 9001.
	 
	 	b.	 	The warranty period for the Components shall be twelve (12)
months from the date of
shipment by TOMOTHERAPY to a customer of a System into which the Components
have been integrated or fifteen (15) months from the date of shipment of the
Components by ANALOGIC to TOMOTHERAPY, whichever period occurs earlier.
ANALOGIC will, at its option, repair or replace defective Components returned
during the warranty period at no cost to TOMOTHERAPY, provided that each Party is
responsible for the shipping cost of the Components it sends to the other.
	 
	 	c.	 	ANALOGIC shall perform an inspection and test of field-returnable Components to
confirm that there is a defect requiring warranty repair or replacement. Returned
Components found not to be defective or no longer under warranty shall be repaired at
TOMOTHERAPY’s expense at ANALOGIC’s then current standard rates for out of
warranty repairs.
	 
	 	 	 	These warranties are made upon the express condition that:

	 	i.	 	ANALOGIC is given prompt notice upon discovery by
TOMOTHERAPY of such nonconformity, with an explanation of the alleged
deficiencies.
	 
	 	ii.	 	Such Product is returned to ANALOGIC at the expense of
TOMOTHERAPY after receipt of a Return Authorization (RA) from ANALOGIC. Upon
their repair or replacement, they shall be returned to TOMOTHERAPY as
directed, at the expense of ANALOGIC.
	 
	 	iii.	 	Examination of such Components by ANALOGIC discloses
that the nonconformity actually exists and was not caused by accident,
misuse, neglect, alteration, improper installation or use, improper repair
or improper testing; and
	 
	 	iv.	 	Such Components (including the Software, as defined
below) have not been modified, altered or changed by any person other than
ANALOGIC or its duly authorized repair agents, and other than modifications
by TOMOTHERAPY as provided under Section 13 a. iii. of this Agreement.

 

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THESE WARRANTIES ARE IN LIEU OF AND EXCLUDE ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, ORAL
OR WRITTEN, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND/OR FITNESS FOR A
PARTICULAR PURPOSE. THE OBLIGATION TO REPLACE OR REPAIR IS THE SOLE REMEDY FOR BREACH OF
WARRANTY. ANALOGIC WILL NOT IN ANY EVENT BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OF ANY KIND WHATSOEVER. ANALOGIC WILL NOT BE LIABLE FOR ANY LOST PROFITS
OR DAMAGES FROM LOSS OF USE, OR LOST DATA, EVEN IF ANALOGIC HAS BEEN ADVISED, KNEW OR SHOULD
HAVE KNOWN OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL THE RESPONSIBILITY AND LIABILITY OF
ANALOGIC IN CONNECTION WITH ANY OF THE COMPONENTS BE GREATER THAN THE PRICE PAID BY TOMOTHERAPY
FOR THE NON-CONFORMING PORTION OF THE COMPONENTS. TOMOTHERAPY ACKNOWLEDGES THAT IT’S EXCLUSIVE
REMEDIES SET FORTH HEREIN ALLOCATE RISKS BETWEEN THE PARTIES FAIRLY AND IN A MANNER WHICH UNDER
NO CIRCUMSTANCES WILL CAUSE SUCH REMEDIES TO FAIL OF THEIR ESSENTIAL PURPOSE.

13. SOFTWARE LICENSE AND WARRANTY

	 	a.	 	Components may contain pre-existing ANALOGIC proprietary software
(“ANALOGIC proprietary software”) and software licensed to ANALOGIC by independent third
parties (ANALOGIC licensed “Third Party Software”). TOMOTHERAPY also may add TOMOTHERAPY
Software to the Components and/or to the System(s) into which the Components are integrated
that may be its own proprietary software or other software licensed by TOMOTHERAPY directly
from other third parties (collectively, TOMOTHERAPY Software). ANALOGIC proprietary Software
and ANALOGIC licensed Third-Party Software are sometimes referred to collectively herein as
the “ANALOGIC Software.” ANALOGIC hereby grants to TOMOTHERAPY for the term of this
Agreement, subject to the conditions set forth herein, a non-exclusive, non-transferable
(except as provided in Section 24 of this Agreement) worldwide license:

	 	i.	 	to market and sublicense the ANALOGIC Software in
object code form only;
	 
	 	ii.	 	to use internally the ANALOGIC proprietary Software
in source code form, solely for the purposes of understanding the operation
of the Product, supporting TOMOTHERAPY’s installed Product base, and
accomplishing the purposes of clause (iii) below; and
	 
	 	iii.	 	to make modifications and improvements to the
ANALOGIC proprietary Software for distribution per clause (i)
above.

Neither TOMOTHERAPY nor any of its sub-licensees shall be permitted to transfer the ANALOGIC
Software in any form except in connection with the sale of a HI-ART II System, or as
provided in Section 24 of this Agreement.

 

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	 	b.	 	During the term of this Agreement, TOMOTHERAPY may sublicense its distributors
to distribute and sub-license the ANALOGIC Software solely in connection with
Customers’ use of the Components which are part of a System purchased by the
customer.
	 
	 	c.	 	TOMOTHERAPY expressly acknowledges that this Agreement does not grant
TOMOTHERAPY the right to copy, reproduce, or transmit in any form the
ANALOGIC Software or any part thereof, or to authorize or permit others to do so,
except as expressly provided herein. TOMOTHERAPY shall not reverse engineer,
decompile or disassemble the ANALOGIC Software not provided hereunder in source
code form.
	 
	 	d.	 	Except as expressly provided herein, all right, title and interest in and to the
ANALOGIC Software shall at all times remain and vest solely with ANALOGIC and
its suppliers. TOMOTHERAPY shall have no access to or rights in the ANALOGIC
licensed Third-Party Software in source code form. Except with respect to
TOMOTHERAPY Software, TOMOTHERAPY agrees that it will not claim or assert
title to the ANALOGIC Software, or attempt to transfer any title thereto to any third
party. This does not apply to software developed specifically for TOMOTHERAPY,
that does not interface directly with hardware that is supplied by ANALOGIC. For
example, software developed under this contract that implements the general machine
control scheme as defined by TOMOTHERAPY, or interfaces with standard 3rd-party
components not supplied by ANALOGIC, shall be owned by TOMOTHERAPY.
	 
	 	e.	 	In the event ANALOGIC changes hardware of the Components for whatever reason the
firmware should continue to function to SPECIFICATIONS.
	 
	 	f.	 	TOMOTHERAPY’s SOLE AND EXCLUSIVE REMEDY AND ANALOGIC’S SOLE LIABILITY HEREUNDER SHALL BE TO
REPLACE ANALOGIC SOFTWARE THAT DOES NOT MEET ANALOGIC’S LIMITED WARRANTY AS SOON AS IS
REASONABLY PRACTICABLE, AND, IF REASONABLY POSSIBLE, TO MAKE THE REPLACEMENT SOFTWARE
AVAILABLE TO TOMOTHERAPY VIA SECURE DOWNLOADING OVER THE INTERNET OR BY OTHER ELECTRONIC
MEDIUM AGREEABLE TO THE PARTIES. THIS SOFTWARE WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, ORAL OR WRITTEN, INCLUDING WITHOUT LIMITATION WARRANTIES OF
MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE. ANALOGIC WILL NOT IN ANY EVENT BE
LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND WHATSOEVER.
TOMOTHERAPY ACKNOWLEDGES THAT IT’S EXCLUSIVE REMEDIES SET FORTH HEREIN ALLOCATE RISKS BETWEEN
THE PARTIES FAIRLY AND IN A MANNER WHICH UNDER NO CIRCUMSTANCES WILL CAUSE SUCH REMEDIES TO FAIL OF THEIR ESSENTIAL PURPOSE.

 

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	 	g.	 	ANALOGIC SHALL HAVE NO LIABILITY OR RESPONSIBILITY FOR ANALOGIC SOFTWARE ALTERED OR
MODIFIED BY TOMOTHERAPY WITHOUT ANALOGIC’S PERMISSION OR A THIRD PARTY OR FOR DAMAGES
RESULTING FROM ACCIDENT, ABUSE, OR MISAPPLICATION OR FOR PROBLEMS DUE IN WHOLE OR IN PART
TO THE USE OR MALFUNCTION OF ANY EQUIPMENT, SOFTWARE OR ACCESSORIES NOT SUPPLIED BY
ANALOGIC OR THE INCOMPATIBILITY THEREOF WITH ANALOGIC SOFTWARE.
	 
	 	h.	 	The Software and documentation is provided with restricted rights. Use,
duplication, or disclosure by TOMOTHERAPY is subject to restrictions as set forth in FAR
Section 52.227-14 (Alternate III) or subparagraph (c)(l)(ii) of the clause at DFAR
252.227-7013, Rights in Technical Data and Computer Software. Contractor/manufacturer is
ANALOGIC Corporation, 8 Centennial Drive, Peabody, Massachusetts 01960.

14. PRODUCT LIABILITY/ INDEMNIFICATION

	 	a.	 	Notwithstanding any other provisions hereof, each Party agrees to indemnify the other,
its officers, agents, servants and employees against claims, damages, demands, suits,
actions, judgments, liabilities, defaults, or costs and expenses, including attorneys’
fees, arising from claims made against or liability imposed upon the other, by a court of
competent jurisdiction as a result of claims alleging personal injury, disability, death or
property damage, or any form or type or wrongdoing or loss arising from such
indemnifying Party’s failure to perform its respective obligations hereunder, as well as,
in TOMOTHERAPY’s case, its obligations implicitly arising out of or in connection
with the sale and/or transfer of the System, including without limitation,
TOMOTHERAPY’s burden of Customer training, service and support, its
representations made in the course of reselling or distributing the System, and its
distribution of related materials and literature. This indemnification shall be limited to
the sum of $2,000,000 in any 12-month period commencing on August 1st of any
year.
	 
	 	b.	 	Each Party hereto agrees that it will maintain product liability insurance adequate to
fulfil the indemnification obligation hereunder in each such 12-month period
commencing on August 1st of each year.
	 
	 	c.	 	In the event that a claim is made against a Party seeking indemnification, that Party
shall promptly notify the other Party of the claim, allow the other Party to defend it in
the name of such Party and to fully cooperate with its insurers, if relevant, and its
counsel in the defense against the claim.

15. PATENTS/INDEMNIFICATIONS

	 	a.	 	ANALOGIC will defend TOMOTHERAPY at ANALOGIC’s cost and expense, including reasonable
attorneys’ fees, against any claim of infringement of a United States, Canadian, or
European Union patent brought against TOMOTHERAPY to the extent that such a claim pertains
to Components designed by ANALOGIC, provided

 

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	 	 	 	that TOMOTHERAPY gives ANALOGIC prompt written notice of such claim and the right to
maintain sole control of the defense and all negotiations for settlement of such claim. If
a final injunction is obtained against TOMOTHERAPY’S use of Components because of
infringement of third Party intellectual property, ANALOGIC will, at ANALOGIC’s option and
at ANALOGIC’s expense, either procure for TOMOTHERAPY the right to continue using the
Components, replace or modify the Components so that the Components become non-infringing,
or grant TOMOTHERAPY credit for the purchase price less reasonable depreciation of
infringing Components and accept the return of Components sold by ANALOGIC to TOMOTHERAPY.
Under the terms of this Agreement, ANALOGIC will not accept any liability, nor hold any
person harmless from infringement claims relating to: (i) Components supplied by ANALOGIC
containing components which have been manufactured or produced by others and which carry
the original manufacturer’s patent indemnifications; (ii) Components purchased hereunder
but altered by TOMOTHERAPY or others (excluding ANALOGIC and ANALOGIC’s authorized agents)
to infringe such patent; and (iii) a combination of Components and other equipment;
provided, however, that ANALOGIC shall defend such claim to the extent that such
infringement claim would lie against the Product notwithstanding such alteration or
combination.
	 
	 	b.	 	Notwithstanding anything to the contrary in this Agreement, if any alleged
infringement of a United States, Canadian, or European Union patent by Components
arisen from designs developed and supplied by TOMOTHERAPY, then ANALOGIC
shall not be required to repair or replace the Components at ANALOGIC’s cost or in
any way indemnify TOMOTHERAPY as set forth in this Agreement.
	 
	 	c.	 	TOMOTHERAPY agrees to defend ANALOGIC at TOMOTHERAPY’s cost and
expense, including reasonable attorneys’ fees, against any claim of patent infringement
by reason of use by Analogic of TOMOTHERAPY’s specifications, intellectual
property, or other information in the Components. TOMOTHERAPY shall indemnify
and hold ANALOGIC harmless against any loss, damage and cost reasonably incurred
by ANALOGIC arising out of or related to such infringement claim.
TOMOTHERAPY’s obligations with respect to such infringement claims are expressly
conditioned upon ANALOGIC giving TOMOTHERAPY prompt notice of such
infringement claim and granting TOMOTHERAPY in writing exclusive control over
ANALOGIC’s defense or settlement and cooperating with TOMOTHERAPY at
TOMOTHERAPY’s expense.

16. CONFIDENTIALITY

The Mutual Non-Disclosure agreement (NDA) signed by the Parties on February 15, 2001, shall
apply during the term of this agreement.

17. COMPLIANCE WITH LAWS

ANALOGIC and TOMOTHERAPY, respectively, represent that they are and will remain in compliance with
all applicable laws, rules, regulations, ordinances, judgments, decrees, orders,

 

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writs and injunctions of all United States government agencies and all foreign governments and
agencies thereof that affect their business, properties or assets.

18. ENTIRE AGREEMENT; NO WAIVER

This Agreement and the Development and Manufacturing Agreement signed October 9 2001, contain the
entire agreement between the parties relating to TOMOTHERAPY’s purchase of the Components from
ANALOGIC. If a conflict develops, this Development and OEM Supply Agreement shall govern. None of
the terms of this Agreement shall be deemed to be waived or amended by either Party unless such
waiver or amendment specifically references this Agreement and is in writing signed by the Party to
be bound. Waiver by either Party of any default by the other will not be deemed a waiver by such
Party of any default by the other that may thereafter occur.

19. FORCE MAJEURE

If performance of this Agreement by ANALOGIC or TOMOTHERAPY is prevented or delayed by reason of
any cause beyond the control of, and without the fault of, the Party affected, except the
obligation to make payment for Components purchased, and which cannot be overcome by commercially
reasonable diligence (including, without limitation, acts of nature, strikes, energy or materials
shortages or obsolescence, acts of civil or military authority (including changes in government
laws and regulations), fires, floods, epidemics, wars and riots), the Party affected shall be
excused from such performance to the extent that it is necessarily prevented or delayed thereby,
during the continuance of any such happening or event, and this Agreement shall be deemed suspended
so long as and to the extent that any such cause prevents or delays its performance. In order to
obtain a suspension under this provision, the Party invoking Force Majeure shall send written
notice thereof to the other Party within a reasonable time after the invoking party knows that
performance would be delayed or prevented due to the Force Majeure in question.

21. LIMITATION OF LIABILITY

NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER PARTY FOR ANTICIPATED PROFITS, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES WITH
RESPECT TO ANY CLAIM ARISING OUT OF THIS AGREEMENT OR ANY PERFORMANCE HEREUNDER, WHETHER SUCH CLAIM
SOUNDS IN TORT, CONTRACT, BREACH OF WARRANTY OR ANY OTHER THEORY. THE REMEDIES GRANTED TO EACH
PARTY HEREIN ARE SOLE AND EXCLUSIVE. EACH PARTY ACKNOWLEDGES THAT IT’S EXCLUSIVE REMEDIES SET FORTH
HEREIN ALLOCATE RISKS BETWEEN THE PARTIES FAIRLY AND IN A MANNER WHICH UNDER NO CIRCUMSTANCES WILL
CAUSE SUCH REMEDIES TO FAIL OF THEIR ESSENTIAL PURPOSE.

22. NOTICES

All notices given under this Agreement shall be in writing and may be delivered (i) by hand,
(ii) by United States mail, certified or registered, return-receipt requested, (iii) by overnight-courier service, or (iv) by facsimile transmission if followed by overnight courier service.

 

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Notices shall be deemed to have been received: if hand delivered, when so delivered; if
mailed, five days after deposit as certified or registered mail; if by courier, on the date
scheduled for delivery; and if by facsimile transmission, on the date shown on the confirmation of
the transmission generated by the sending machine. All notices shall be sent to the addresses and
facsimile numbers set forth below (or at such address or facsimile number as the receiving Party
may specify from time to time in accordance with this Section):

	 	 	 
	If to TOMOTHERAPY:

	 	If to ANALOGIC
	 
	 	 
	TOMOTHERAPY, Inc.

	 	ANALOGIC Corporation
	1240 Deming Way

	 	8 Centennial Drive
	Madison, WI 53717

	 	Peabody, MA 01960
	 
	 	 
	Attention: John J. Barni, CEO

	 	Attention:Lonnie Weaver
	 
	 	 
	Facsimile: 608-824-2996

	 	Facsimile: 978-977-6805
	 
	 	 
	with a copy to:

	 	with a copy to:
	 
	 	 
	La Follette Godfrey & Kahn

	 	General Counsel
	Attn: Michael E. Skindrud

	 	ANALOGIC Corporation
	One East Main Street

	 	8 Centennial Drive
	Madison, WI 53703

	 	Peabody, MA 01960
	 
	 	 
	Facsimile: 608-257-0609

	 	Facsimile: 978-977-6802

23. DISPUTE RESOLUTION

If a dispute arises out of or relates to this Agreement, or its breach, and the Parties have not
been successful in resolving such dispute through negotiation, the Parties agree to resolve the
dispute through binding arbitration in accordance to the rules of the American Arbitration
Association (“AAA”). Unless the Parties can agree to a sole arbitrator, there shall be three (3)
arbitrators, with each party appointing one arbitrator, who collectively will select a third. Each
party shall bear its own expenses and an equal share of the expenses of the arbitrator and the fees
of the AAA. The Parties, their representatives, other participants and the arbitrator(s) shall hold
the existence, content and result of the arbitration in confidence. This Agreement shall be
enforceable, and any arbitration award shall be final, and judgment thereon shall be entered into
any court of competent jurisdiction. Nothing in this clause shall be construed to preclude any
party from seeking injunctive relief in order to protect its rights pending arbitration. A request
by a party to a court for such injunctive relief shall not be deemed a waiver of the obligation to
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If ANALOGIC initiates the arbitration process, the arbitration shall be held in
Milwaukee,Wisconsin. If TOMOTHERAPY initiates the arbitration process, the arbitration
shall be held in Boston, Massachusetts.

24. ASSIGNMENT

This Agreement shall be binding upon and inure to the benefit of the parties, their successors and
assigns. This Agreement shall not be assignable by either party without the prior written consent
of the other, which consent shall not be unreasonably refused, except that in the event that a
third party acquires substantially all assets of TOMOTHERAPY, TOMOTHERAPY may assign this agreement
without ANALOGIC’s consent provided that the third party agrees to be bound by all of the terms of
this Agreement, including but not limited to ANALOGIC’S right to be the exclusive supplier of all
items or Components it has designed; and that any ANALOGIC Technology so assigned will not be used
in the design and manufacture of substitutes for new or different versions of the Components.

25. GOVERNING LAW; SEVERABILITY

This Agreement shall be governed by and construed in accordance with the internal laws of the state
of New York. If any portion of this Agreement is found by a court of competent jurisdiction to be
illegal, invalid or unenforceable, such portion shall be deleted and all other terms and conditions
of this Agreement shall remain in full force and effect and shall be interpreted to achieve, to the
greatest extent possible, the objectives of this Agreement taken as a whole, including the illegal,
invalid or unenforceable provision.

26. PUBLICITY

Unless expressly approved in advance and in writing by the other party, neither party shall make
any reference to the other, but may do so as to the subject matter of this Agreement in any
publicity, advertising or other public statements or documents. Neither party will disclose to
others, without the other’s consent, the fact that it is acting on behalf of the others.

27. COUNTERPART

This Agreement may be executed in any number of counterparts, ANALOGIC of which shall be considered
an original and all of which shall constitute one and the same instrument.

28. NO THIRD PARTY BENEFICIARIES

Nothing in this Agreement is intended to create any rights by persons not a Party to this
Agreement and no other Party will be construed to be a third Party beneficiary of this
Agreement or otherwise have any legal or equitable rights as a result of this Agreement.

29. SURVIVAL

Notwithstanding the expiration or termination of this Agreement, Sections 11,12,13,14, 15, and
21,the rights that have been given to purchasers of the Products during the term(s) of this
Agreement to ANALOGIC Information and Proprietary Technology, TOMOTHERAPY Information and
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Software, as well as such other provisions hereof where the sense and context so
admits, will survive in accordance with their terms.

30. MANUFACTURING RIGHTS

Notwithstanding, anything herein to the contrary, if at any time during the Agreement
there is a force majeure failure or inability on ANALOGIC’s part to deliver the
Components duly ordered by TOMOTHERAPY for a period of 60 days, and during this period of
time ANALOGIC fails to provide TOMOTHERAPY with a realistic plan for resumption of the
Components manufactured prior to the expiration of the ninetieth (90th) day
following failure to deliver the Components, then TOMOTHERAPY will have the manufacturing
rights to produce the Components until such time as ANALOGIC is reasonably capable of
resuming the manufacturing of the Components.

IN WITNESS WHEREOF, authorized representatives of the parties have executed this
Agreement as of the Effective Date.

	 	 	 	 	 
	 	 	TOMOTHERAPY INCORPORATED a Wisconsin

corporation
	 
	 	 	 	 
	 

	 	By:
	 	/s/ John J. Barni
	 

	 	 	 	 
	 

	 	Title:
	 	CEO 2/4/03
	 

	 	 	 	 
	 
	 	 	 	 
	 	 	ANALOGIC Corporation, a

Massachusetts corporation,
	 
	 	 	 	 
	 

	 	By:
	 	/s/ (illegible)
	 

	 	 	 	 
	 

	 	Title:
	 	CEO 2/5/03
	 

	 	 	 	 

 

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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

Analogic-TomoTherapy Development and OEM

Supply Agreement

Exhibit 1: Specifications

	 	 	 	 	 	 	 	 	 
	Rev	 	CA No	 	Date	 	Comment	 	Originator
	0

	 	-
	 	4/24/02
	 	Initial revision — added PDU, Computers, disk
components to first contract for review
	 	D. Murray
	1

	 	-
	 	6/25/02
	 	Modifications following review by Bob Riemer,
Dave Murray, and many others
	 	D Murray
	2

	 	-
	 	1/14/03
	 	Modifications following phone discussion between Weaver, Riemer, Murray
	 	D Murray
	3

	 	-
	 	1/14/03
	 	Corrected issue with Section 10 heading
	 	D Murray
	4

	 	-
	 	1/20/03
	 	Change Exhibit 1 reference to Analogic family tree
	 	D Murray
	5

	 	-
	 	1/20/03
	 	Change Exhibit 1 reference to AN6500 (from
“TomoTherapy Gantry”)
	 	D Murray

COMPANY CONFIDENTIAL

This
document contains confidential or proprietary information of TomoTherapy, Inc.
Neither this document nor the information contained therein is to be reproduced,
distributed, used or disclosed, either in whole or in part, except as specifically
authorized by TomoTherapy, Inc.

 

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Table of Contents

	 	 	 	 	 	 	 	 	 	 	 
	1	 	Scope	 	 	4	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	1.1	 	Identification	 	 	4	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	1.2	 	Statement of System’s Intended Use	 	 	4	 
	 
	 	 	 	 	 	 	 	 	 	 
	2	 	Standards and Regulations	 	 	4	 
	 
	 	 	 	 	 	 	 	 	 	 
	3	 	Types of Users	 	 	5	 
	 
	 	 	 	 	 	 	 	 	 	 
	4	 	System Architecture	 	 	5	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	4.1	 	System Data Flow	 	 	7	 
	 
	 	 	 	 	 	 	 	 	 	 
	5	 	Gantry Subsystem Requirements	 	 	8	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	5.1	 	Scope	 	 	8	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	5.2	 	Functional Requirements	 	 	8	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.1	 	General	 	 	8	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.2	 	Gantry Frame	 	 	8	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.3	 	Gantry Mechanical	 	 	8	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.4	 	Gantry Component Mounting	 	 	9	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.5	 	Slip Ring System	 	 	9	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.6	 	Gantry Control	 	 	10	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	5.2.7	 	Data Communication	 	 	10	 
	 
	 	 	 	 	 	 	 	 	 	 
	6	 	Couch Subsystem Requirements	 	 	11	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	6.1	 	Scope	 	 	11	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	6.2	 	Functional Requirements	 	 	11	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	6.2.1	 	General	 	 	11	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	6.2.2	 	Mechanical	 	 	11	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	6.2.3	 	Control	 	 	11	 
	 
	 	 	 	 	 	 	 	 	 	 
	7	 	DAS Subsystem Requirements	 	 	13	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	7.1	 	Scope	 	 	13	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	7.2	 	Functional Requirements	 	 	13	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	7.2.1	 	General	 	 	13	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	7.2.2	 	Electronics	 	 	13	 
	 
	 	 	 	 	 	 	 	 	 	 
	8	 	Power Distribution Unit (PDU) Subsystem Requirements	 	 	14	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	8.1	 	Scope	 	 	14	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	8.2	 	Functional Requirements	 	 	14	 

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	8.2.1	 	General	 	 	14	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	8.2.2	 	Electrical	 	 	14	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	8.2.3	 	Control	 	 	15	 
	 
	 	 	 	 	 	 	 	 	 	 
	9	 	Control Computer Requirements	 	 	16	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	9.1	 	Scope	 	 	16	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	9.2	 	Functional Requirements	 	 	16	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	9.2.1	 	General	 	 	16	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	9.2.2	 	Stationary Controller (STC) Hardware	 	 	16	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	9.2.3	 	On-Board Controller (OBC) Hardware	 	 	17	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	9.2.4	 	Data Receiver Server (DRS) Hardware	 	 	17	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	9.2.5	 	Software Drivers	 	 	17	 
	 
	 	 	 	 	 	 	 	 	 	 
	10	 	Gantry Component Requirements	 	 	19	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	10.1	 	Scope	 	 	19	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	10.2	 	Functional Requirements	 	 	19	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	10.2.1	 	Circuit Boards	 	 	19	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	10.2.2	 	List of Gantry Components with Analogic Involvement	 	 	21	 

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

1 Scope

	 	1.1	 	Identification
	 
	 	 	 	The following subsystems are addressed by this document:

	 	•	 	TomoTherapy Hi-Art II Gantry Subsystem, including mounting of certain Analogic-
and TomoTherapy-supplied components.
	 
	 	•	 	TomoTherapy Hi-Art II Couch Subsystem.
	 
	 	•	 	TomoTherapy Hi-Art II DAS Subsystem.
	 
	 	•	 	TomoTherapy Hi-Art II Communications Subsystem.
	 
	 	•	 	TomoTherapy Hi-Art II Power Distribution Unit (PDU)
	 
	 	•	 	TomoTherapy Hi-Art II Control Computers

	 	1.2	 	Statement of System’s Intended Use
	 
	 	 	 	The TomoTherapy Hi•Art system is intended to be used to provide conformal
radiation therapy for patients who have been deemed acceptable candidates for
radiation treatment of cancer. Its purpose is to precisely deliver beams of
radiation, automatically tailored to the individual case, with immediate
verification.

2 Standards and Regulations

	 	 	 	The TomoTherapy Hi•Art System shall be designed to promote conformance with
design standards:

	 	•	 	IEC 60601-1: Medical Electric Equipment — Part 1: General Requirements for Safety
	 
	 	•	 	UL 2601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety (USA version
of international requirements)
	 
	 	•	 	IEC 60601-1-2: Medical Electric Equipment — Part 1: General Requirements for Safety;
Electromagnetic Compatibility — Requirements and Tests
	 
	 	•	 	IEC 60601-1-4: Medical Electric Equipment — Part 1: General Requirements for Safety; 4.
Collateral Standard: Programmable Electrical Medical Systems
	 
	 	•	 	IEC 60601-2-1: Medical Electric Equipment — Part 2: Particular Requirements for Medical
Electron Accelerators in the Range 1 MeV to 50 MeV
	 
	 	•	 	IEC 61217: Radiotherapy equipment — coordinates, movements and scales (1996-08)
	 
	 	•	 	IEC/TR 62266 (2002-03): Medical electrical equipment: Guidelines for implementation of DICOM in
radiotherapy

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

	 	•	 	ANSI/AAMI HE48: Human Factors Engineering Guidelines and Preferred Practices for the Design of
Medical Devices.

3 Types of Users

	 	•	 	Physicians/Oncologists
	 
	 	•	 	Technicians
	 
	 	•	 	Physicists
	 
	 	•	 	Service personnel

4 System Architecture

	 	The architecture for the TomoTherapy Hi•Art system can be broken down
into three major subsystems: 1) Planning subsystem, 2) Delivery subsystem, and 3)
Database server.

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

Figure 1 System Architecture

[*]

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

	 	4.1	 	System Data Flow
	 
	 	 	 	The figure below illustrates the flow of data between each component of the
HI•ART system. All data is accessed from, and saved to, the Database Server.
	 
	 	 	 	Figure 2 System Data Flow

[*]

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

5 Gantry Subsystem Requirements

	 	5.1	 	Scope

	 	 	 	The gantry subsystem includes the gantry frame, bearings, slip-rings, rotating
mounting plate, and data communication components.

	 	5.2	 	Functional Requirements

	 	5.2.1	 	General

	 	5.2.1.1	 	The gantry system shall conform to [*],
[*], and [*] when incorporating Analogic components.
	 
	 	5.2.1.2	 	Communication software between Analogic components needed for the
implementation of the TomoTherapy system shall be supplied, except for
3rd party development tools and environments that may be sourced
directly by TomoTherapy Inc.

	 	5.2.2	 	Gantry Frame

	 	5.2.2.1	 	The gantry frame shall be capable of supporting at least [*] kg with a safety
factor of at least [*].
	 
	 	5.2.2.2	 	The depth of the gantry frame shall be [*] mm or less.
	 
	 	5.2.2.3	 	The width of the gantry frame shall be [*] mm or less.
	 
	 	5.2.2.4	 	The maximum height of the entire gantry system shall be [*] mm or less.

	 	5.2.3	 	Gantry Mechanical

	 	5.2.3.1	 	The gantry shall be capable of rotating at a speed of up to [*] r.p.m.
	 
	 	5.2.3.2	 	The gantry bearing shall have a life exceeding [*] years normal clinical use at
[*] r.p.m., under a load of [*] kg cantilevered at [*] mm.
	 
	 	5.2.3.3	 	The gantry must be sufficiently rigid to hold the position of the detector to
within [*] ìm of the center of rotation, independently of gantry rotational
position.
	 
	 	5.2.3.4	 	[*]
	 
	 	5.2.3.5	 	[*]
	 
	 	5.2.3.6	 	[*]
	 
	 	5.2.3.7	 	The gantry motor drive shall be capable of providing a steady state torque of
at least [*] N.m. ([*] ft.lb).

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

	 	5.2.3.8	 	The gantry motor drive shall also be capable of providing sufficient additional
torque to accelerate the fully-loaded gantry to the maximum specified rotation
speed in less than [*] seconds.
	 
	 	5.2.3.9	 	The gantry motor drive controller shall control the gantry position to within
[*] degree of the specified position.
	 
	 	5.2.3.10	 	The inside diameter of the unpopulated gantry before the external covers are
fitted shall be [*] cm or greater.

	 	5.2.4	 	Gantry Component Mounting

	 	5.2.4.1	 	Provision shall be made on the gantry for the mounting of the linear
accelerator, primary collimation system, collimating jaws, and multi-leaf
collimator.
	 
	 	5.2.4.2	 	Provision shall be made on the gantry for the mounting of the CT detector, DAS,
and associated power supplies.
	 
	 	5.2.4.3	 	Provision shall be made on the gantry for the mounting of a solid-state
modulator power supply, solid-state modulator, magnetron, circulator, and
associated electronics.
	 
	 	5.2.4.4	 	There must be sufficient space on the gantry for the mounting of a conventional
modulator and power supply instead of the solid-state modulator.
	 
	 	5.2.4.5	 	Space shall be available on the gantry for the mounting of the on board
computers.
	 
	 	5.2.4.6	 	Space shall be available on the gantry for the mounting of small low-voltage
power supplies to supply the various electrical components.
	 
	 	5.2.4.7	 	Provision shall be made on the gantry to allow for the routing of cooling pipes
or flexible tubing to and from the cooled components.
	 
	 	5.2.4.8	 	Provision shall be made on the gantry to allow for the routing of signal cables
to the electronic components.
	 
	 	5.2.4.9	 	Provision shall be made on the gantry to allow for the routing of power cables
to the electronic components, separated from the signal cables where possible.
	 
	 	5.2.4.10	 	Provision shall be made on the gantry to allow for the routing of compressed
air to the MLC assembly, including mounting of an accumulator tank.

	 	5.2.5	 	Slip Ring System

	 	5.2.5.1	 	The gantry slip-ring system shall support two-way Ethernet communication with a
data rate of at least [*] Mbit/sec, with necessary electronics provided to account
for transmission line effects.
	 
	 	5.2.5.2	 	The gantry slip-ring system shall provide [*] low-power, low voltage lines for
use in the hardware interlock system.
	 
	 	5.2.5.3	 	The gantry slip-ring system shall provide [*] power
rings ([*] signal, [*]
signal ground, [*] safety ground), capable of handling either [*] A per phase at
[*] V or [*] A per phase at [*] V.

	 	 	 
	 
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	 	5.2.5.4	 	The gantry slip-ring system shall provide [*] spare low power, low voltage slip
ring.

	 	5.2.6	 	Gantry Control

	 	5.2.6.1	 	A gantry angle detection system shall be provided.
	 
	 	5.2.6.2	 	The instantaneous gantry angle to the within [*] degrees must be available to
the control software on the rotating side.
	 
	 	5.2.6.3	 	The gantry angle must be made available across the data communication system
(see below) with a known latency, to control stationary side components.

	 	5.2.7	 	Data Communication

	 	5.2.7.1	 	A one-way data transmission for sending DAS and monitor signal data from the
rotating side to the stationary side of the gantry shall be provided.
	 
	 	5.2.7.2	 	The data transmission system shall be capable of detecting and signaling data
transmission violation errors.
	 
	 	5.2.7.3	 	The data transmission system shall support transfer of up to [*] channels of
DAS data at up to [*] views per second.
	 
	 	5.2.7.4	 	The underlying data transmission system technology shall be
capable of transferring data fast enough to handle a multi-row
detector of at least [*] rows, [*] channels per
row, at [*] views per second.

	 	 	 
	 
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6 Couch Subsystem Requirements

	 	6.1	 	Scope
	 
	 	 	 	The couch (table) subsystem includes the physical patient support and the
control and
output electronics and software interfaces associated with it.
	 
	 	6.2	 	Functional Requirements

	 	6.2.1	 	General

	 	6.2.1.1	 	The couch system shall conform to [*], and [*], when incorporating Analogic
components.
	 
	 	6.2.1.2	 	Communication software between Analogic components needed for the
implementation of the TomoTherapy system shall be supplied, except
for 3rd party development tools and environments that may
be sourced directly by TomoTherapy Inc.

	 	6.2.2	 	Mechanical

	 	6.2.2.1	 	There shall be no metal structural members within the pallet
in the scan region.
	 
	 	6.2.2.2	 	The total longitudinal couch travel shall be at least
[*]m.
	 
	 	6.2.2.3	 	The maximum possible couch height when installed shall be no less than the
height of the machine isocenter, namely [*] cm. Additional “feet” may need to be
added to the couch by TomoTherapy or Analogic to achieve this.
	 
	 	6.2.2.4	 	The minimum possible couch height when installed shall be no greater than [*]
cm.
	 
	 	6.2.2.5	 	The couch width shall be that of a standard [*] couch, namely [*] cm.
	 
	 	6.2.2.6	 	The couch thickness shall be [*].
	 
	 	6.2.2.7	 	Total couch sag when maximally extended at a plane [*] mm from the cradle pivot,
relative to an unloaded couch, shall not exceed [*]mm when a load of [*]kg is
placed [*]mm from the cradle pivot.
	 
	 	6.2.2.8	 	In the case of couch failure, it shall be possible to release the couch pallet
and withdraw the patient from the gantry bore.

	 	6.2.3	 	Control

	 	 	 
	 
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	 	6.2.3.1	 	At any time, the absolute longitudinal position of the couch to within [*]μm shall be
available to control software via polling, at speeds of less than or equal to [*] mm/sec.
	 
	 	6.2.3.2	 	At any time, feedback on the absolute vertical position of the couch shall be available via
a [*].
	 
	 	6.2.3.3	 	It shall be possible to command the couch to move longitudinally at speeds as low as [*]
μm/sec.
	 
	 	6.2.3.4	 	It shall be possible to command the couch to move longitudinally at speeds as high as [*]
mm/sec.
	 
	 	6.2.3.5	 	The couch shall provide a software interface to allow a remote computer to
control its movements and poll for feedback.
	 
	 	6.2.3.6	 	The couch shall be capable of signaling the controlling computer via
hardware when an internal (watchdog) failure is detected.

	 	 	 
	 
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7 DAS Subsystem Requirements

	 	7.1	 	Scope
	 
	 	 	 	The DAS subsystem includes the electronics to convert the detector signals and
other rotating-side monitoring signals and provide it in a form that can be used by
the rest of the system.
	 
	 	7.2	 	Functional Requirements

	 	7.2.1	 	General

	 	7.2.1.1	 	The radiation therapy system shall conform to [*], [*], and [*], when
incorporating Analogic DAS components.
	 
	 	7.2.1.2	 	Communication software between Analogic components needed for the
implementation of the TomoTherapy system shall be supplied, except for
3rd party development tools and environments that may be sourced
directly by TomoTherapy Inc.

	 	7.2.2	 	Electronics

	 	7.2.2.1	 	The DAS shall support at least [*] detector channels.
	 
	 	7.2.2.2	 	The DAS shall support [*] additional data channels for other on-board signals
(some [*]V pulsed, some [*]V DC, some charge-based).
	 
	 	7.2.2.3	 	The DAS shall be designed to work with the [*], model number [*].
	 
	 	7.2.2.4	 	The DAS shall provide a minimum of [*] bits of resolution.
	 
	 	7.2.2.5	 	The DAS shall support view rates of [*] to [*] Hz.
	 
	 	7.2.2.6	 	[*]
	 
	 	7.2.2.7	 	[*]

	 	 	 
	 
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8 Power Distribution Unit (PDU) Subsystem Requirements

	 	8.1	 	Scope
	 
	 	 	 	The PDU subsystem includes electrical components to isolate and transform mains
power, and distributing it to various components of the TomoTherapy Hi-Art II System.
	 
	 	8.2	 	Functional Requirements

	 	8.2.1	 	General

	 	8.2.1.1	 	The PDU shall be certified and labeled to comply with [*], [*], [*].

	 	8.2.2	 	Electrical

	 	8.2.2.1	 	The PDU shall accept the following AC 3-phase input voltages at [*]Hz:
[*]V, [*]V, [*]V, [*]V and [*]V.
	 
	 	8.2.2.2	 	For each allowable input voltage, a constant input voltage shall result in the
nominal [*] output having a value between [*]% and [*]% of the [*]V value.
	 
	 	8.2.2.3	 	For each allowable input voltage, a constant input voltage shall result in the
nominal [*] output having a value between [*]% and [*]% of the [*]V value.
	 
	 	8.2.2.4	 	There shall be a circuit breaker on the input side of the transformer,
accessible from outside the PDU. All output side breakers shall not be accessible
from outside the PDU.
	 
	 	8.2.2.5	 	The PDU shall be rated for [*]% duty cycle on all outputs.
	 
	 	8.2.2.6	 	The PDU shall provide [*]A at [*]VAC (3-phase) with a circuit breaker, for
powering the gantry slip rings. A neutral and a safety ground shall also be
supplied.
	 
	 	8.2.2.7	 	The PDU shall provide [*]A at [*] VAC (3-phase), with a circuit breaker, for
powering the compressor.
	 
	 	8.2.2.8	 	The PDU shall provide [*]A at [*] VAC (3-phase), with a circuit breaker for
powering the pump stand.
	 
	 	8.2.2.9	 	The PDU shall provide sufficient power, with a circuit breaker, for powering
the couch supplied by Analogic.
	 
	 	8.2.2.10	 	The PDU shall provide sufficient power, with a circuit breaker, for powering
the gantry drive supplied by Analogic.
	 
	 	8.2.2.11	 	The PDU shall provide a total of [*]A at [*] VAC (single phase) over 3
outlets, each with a circuit breaker, for powering the Stationary Controller
(STC), lasers, and gantry display.

	 	 	 
	 
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	 	8.2.2.12	 	The PDU shall provide [*]A at [*] VAC (single phase), with a circuit breaker,
for powering the Data Receiver Server (DRS). This supply shall be protected by an
uninterruptible power supply (UPS), delivering the rated load for a minimum of
[*] minutes.
	 
	 	8.2.2.13	 	The PDU shall provide [*]A at [*] VAC (single phase), with a circuit breaker,
for powering the Operator Station and monitor.
	 
	 	8.2.2.14	 	The PDU shall provide [*] ingress protection per [*].
	 
	 	8.2.2.15	 	All power connections to the PDU shall be either hard-wired, or locking-type
plugs.
	 
	 	8.2.2.16	 	The PDU shall monitor output voltage on the [*] outputs, and provide an
output signal indicating whether or not the voltage is within [*]% to [*]% of
the nominal value.

	 	8.2.3	 	Control

	 	8.2.3.1	 	The PDU shall be capable of disabling power to the disk in response to an
external control signal (the “disk off” signal).
	 
	 	8.2.3.2	 	The PDU shall provide an output signal that indicates the status of the power
phases.
	 
	 	8.2.3.3	 	The PDU outputs shall not be able to be turned on unless an external key
switch control signal is active.
	 
	 	8.2.3.4	 	The PDU shall remove power from the outputs in response to either of two
external control signals (the “off” or “key enable” signals).
	 
	 	8.2.3.5	 	The PDU outputs shall turn on if both of two external control signals (the
“key enable” and “system on” signals) are active.
	 
	 	8.2.3.6	 	The PDU shall open the main input-side breaker in response to
[*] (the “[*]”).
	 
	 	8.2.3.7	 	The PDU outputs shall not provide output power unless [*] (the “[*]”) is connected.
	 
	 	8.2.3.8	 	The PDU shall provide [*], [*] (for operating the door indicator system).
	 
	 	8.2.3.9	 	The PDU shall provide a [*]. The PDU shall provide [*].

	 	 	 
	 
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9 Control Computer Requirements

	 	9.1	 	Scope
	 
	 	 	 	The Control Computers include the computer chassis, boards, and software
components needed to control the operation of the TomoTherapy Hi-Art II delivery
subsystem. The control computers include: On-board Controller (OBC), Stationary
Controller (SBC), and Data Receiver Server (DRS).
	 
	 	9.2	 	Functional Requirements

	 	9.2.1	 	General

	 	9.2.1.1	 	All circuit boards used in the control computers shall be certified to [*], and
be labeled as such.
	 
	 	9.2.1.2	 	All circuit boards used in the control computers shall be designed to standards
[*] and [*].
	 
	 	9.2.1.3	 	The control computers shall consist of three separate boxes: the Stationary
Controller (STC); On-Board Controller (OCB), and Data Receiver Server (DRS).
	 
	 	9.2.1.4	 	The control computers shall each have status indicators indicating if the
computer is functioning normally or in one or more error states.
	 
	 	9.2.1.5	 	The control computers shall each be constructed in a manner consistent with the
requirements of [*].
	 
	 	9.2.1.6	 	The control computers shall each be supplied with one [*].
	 
	 	9.2.1.7	 	On each compute, Analogic shall pre-install a [*] and [*]. Alternatively,
Analogic shall install a [*] supplied by TomoTherapy if and when it becomes
available. The software supplied to Analogic will be subject to change, but shall
be provided by TomoTherapy in a controlled way and with sufficient notice to allow
integration into Analogic’s manufacturing process.

	 	9.2.2	 	Stationary Controller (STC) Hardware

	 	9.2.2.1	 	The STC shall provide I/O lines to control the gantry motor drive, supplied by
Analogic.
	 
	 	9.2.2.2	 	The STC shall provide hardware I/O lines to interface with the [*].
	 
	 	9.2.2.3	 	The STC shall provide an Ethernet connection to the delivery subsystem
communications network and gantry displays.
	 
	 	9.2.2.4	 	The STC shall provide hardware I/O lines to interface with the [*].
	 
	 	9.2.2.5	 	The STC shall provide hardware I/O lines to interface with the [*].

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

	 	9.2.2.6	 	The STC shall provide hardware I/O lines to interface with the [*].
	 
	 	9.2.2.7	 	The STC shall provide hardware I/O lines to interface with the [*].
	 
	 	9.2.2.8	 	The STC shall provide hardware I/O lines to interface with the [*], supplied by [*].
	 
	 	9.2.2.9	 	The STC shall provide hardware I/O lines to interface with [*] and [*] for [*] and [*].

	 	9.2.3	 	On-Board Controller (OBC) Hardware

	 	9.2.3.1	 	The OBC shall be able to operate correctly when rotating at speeds between and including [*] r.p.m. and [*] r.p.m.
	 
	 	9.2.3.2	 	The OBC shall provide Ethernet connection to the delivery
subsystem communications network.
	 
	 	9.2.3.3	 	The OBC shall provide hardware I/O lines to interface with the [*].
	 
	 	9.2.3.4	 	The OBC shall provide hardware I/O lines to interface with the [*].
	 
	 	9.2.3.5	 	The OBC shall provide hardware I/O lines to interface with the  [*] ([*]) subsystem.
	 
	 	9.2.3.6	 	The OBC shall provide hardware I/O lines to interface with the [*]  ([*]) subsystem.
	 
	 	9.2.3.7	 	The OBC shall provide an interface to the [*] ([*]) subsystem, supplied by [*].
	 
	 	9.2.3.8	 	The OBC shall provide electronics to prepare the [*] and [*] for transfer over the high
speed data transmission system, supplied by [*].

	 	9.2.4	 	Data Receiver Server (DRS) Hardware

	 	9.2.4.1	 	The DRS shall provide an Ethernet connection to the delivery subsystem communications
network.
	 
	 	9.2.4.2	 	The DRS shall provide a separate Ethernet port for connection to the external
communications network (of which the TomoTherapy Hi-Art II Operator Station forms a part).
	 
	 	9.2.4.3	 	The DRS shall provide electronics to receive the [*] and [*] transferred over the high
speed data transmission system, supplied by [*].
	 
	 	9.2.4.4	 	The DRS shall provide a set of [*] ([*]), that can be used to implement [*] on [*] that are
received from the [*].

	 	9.2.5	 	Software Drivers
	 
	 	 	 	The following software drivers shall be supplied by Analogic with a royalty-free
license to use on the TomoTherapy Hi-Art II System:

	 	 	 
	 
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	9.2.5.1
	 	[*]
	 
	 	 
	9.2.5.2
	 	[*]
	 
	 	 
	9.2.5.3
	 	[*]
	 
	 	 
	9.2.5.4
	 	[*]
	 
	 	 
	9.2.5.5
	 	[*]
	 
	 	 
	9.2.5.6
	 	[*]
	 
	 	 
	9.2.5.7
	 	[*]
	 
	 	 
	9.2.5.8
	 	[*]

	 	 	 
	 
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	 	AGREEMENT — EXHIBIT 1	 	 	 	 	 	 

Gantry Component Requirements

	 	10.1	 	Scope
	 
	 	 	 	Analogic will supply a number of components on the gantry subsystem when delivered to
TomoTherapy. These components include, but are not limited to, power supplies, circuit
breakers, cables, and circuit boards. Analogic will perform the following tasks in
relation to this work:

	 	•	 	Developing, along with TomoTherapy, the system design.
	 
	 	•	 	Selecting and/or sourcing the components (see Section 10.2.2 below).
	 
	 	•	 	Designing and developing components (see Section 10.2.2 below).
	 
	 	•	 	Developing control software for selected components (as
described in Exhibit 2, “Milestones”).
	 
	 	•	 	Fabricating, assembling, and integrating the Analogic portion
of the Hi-Art II prototype subsystem.
	 
	 	•	 	Assisting TomoTherapy with integration of the
Analogic-developed portion of the Hi-Art II prototype with the
TomoTherapy-developed portion of the Hi-Art II prototype.

	 	10.2	 	Functional Requirements

	 	10.2.1	 	Circuit Boards
	 
	 	 	 	Based upon TomoTherapy requirements specifications, Analogic shall design and
manufacture the following circuit boards for use in the TomoTherapy Hi-Art II System:

	 	10.2.1.1	 	MLC Control Board
	 
	 	 	 	The MLC Control Board provides an interface from the [*] to the [*]. The
board isolates the [*] signals from and routes power to the [*].

	 	10.2.1.2	 	PDU and Interlock Control Board

	 	•	 	The PDU and Interlock Control Board provides an interface to the
[*], [*] and [*]. It forwards the [*] to the [*] to disable the [*]
and [*]. It also forwards the signal to the [*]
to turn off the disk power.
	 
	 	•	 	The PDU and Interlock Control Board also interfaces with the [*]
to break or make the interlock depending on the status of the [*]
from the [*]. The status of the door interlock is [*].

	 	 	 
	 
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	 	•	 	The PDU and Interlock Control Board provides an interface to the
[*] with the [*] to allow it to make and break the interlock. The
[*] can also read the interlock status from the board. The board
also requires the computers to send a [*].
	 
	 	•	 	The PDU and Interlock Control Board provides an interface to [*]
to allow [*] to any one of [*] preconfigured angles of [*],[*],[*],
and [*] degrees.

	 	10.2.1.3	 	Linac Moderator Interface Board
	 
	 	 	 	The linac modulator interface board provides an interface from the [*]
to the [*], [*], [*], and [*]. In response to signals from the [*], it
controls [*] to the linac subsystem. Also, a high voltage
interlock circuit on this board is connected to the high voltage
interlock line, and
will [*] and [*] when the [*] [*].
	 
	 	10.2.1.4	 	AUX Input Board
	 
	 	 	 	The AUX Board provides an interface from the [*] to the [*]. It also monitors
[*] and [*] and [*] when [*] specified values.
	 
	 	 	 	Signals processed by the AUX board include:

	 	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]
	 
	 	 
	[*]
	 	[*]

	 	 	 
	 
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	 	 	[*]
	 

	[*]	 	[*]
	 

	[*]	 	[*]

	 	10.2.1.5	 	Detector Gang Boards
	 
	 	 	 	The detector gang boards interface between the [*] (model number [*]) backplane and
the detector cables that lead to the Analogic DAS. Each board combines [*] backplane
connectors ([*] channels) into a single [*] connector.

	 	10.2.2	 	List of Gantry Components with Analogic Involvement
	 
	 	 	 	In addition to the circuit boards, Analogic will supply other components and cables to
be mounted on the gantry prior to shipment.
	 
	 	 	 	The document in Exhibit lb ([*], [*], Analogic
document number [*]) defines the components that will have Analogic
involvement, including the circuit boards described above.
	 
	 	 	 	For each component, Analogic will either manufacture the component, or source the
component directly. In either case the cost of the component will be included in the
Analogic quoted price. The component will be mounted on the [*] gantry by Analogic
prior to shipment (some of the components may be unmounted before shipping as agreed by
both parties).
	 
	 	 	 	TomoTherapy will provide Analogic with a [*] assembly (TomoTherapy assembly part number
[*]), which includes the [*] and [*] adjustors. These components will be mounted on the
[*] gantry by Analogic before shipment.

	 	 	 
	 
	QUALITY RECORD, Template F4-18 REV A

	 	TomoTherapy, Inc.
	Verify Latest Revision Before Using

	 	COMPANY CONFIDENTIAL

 

Table of Contents

Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03

Exhibit 2: Milestones/Payments

I. Original Agreement

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	1
	 	Contract Signing	 	$	[*]	 	 	10/01
	 
	 	 	 	 	 	 	 	 
	2
	 	Delivery of Rotating Test Bed	 	$	[*]	 	 	1/02
	 
	 	 	 	 	 	 	 	 
	3
	 	Design Review	 	$	[*]	 	 	10/01
	 
	 	 	 	 	 	 	 	 
	4
	 	Delivery of Table #1	 	$	[*]	 	 	10/01
	 
	 	 	 	 	 	 	 	 
	5
	 	Delivery of DAS #1	 	$	[*]	 	 	1/02
	 
	 	 	 	 	 	 	 	 
	6
	 	Delivery of Rx/PTM #1	 	$	[*]	 	 	5/02
	 
	 	 	 	 	 	 	 	 
	7
	 	Delivery of DAS #2	 	$	[*]	 	 	3/02
	 
	 	 	 	 	 	 	 	 
	8
	 	Delivery of Rx/PTM #2	 	$	[*]	 	 	5/02
	 
	 	 	 	 	 	 	 	 
	9
	 	Delivery of DAS #3	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	10
	 	Delivery of Rx/PTM #3	 	$	[*]	 	 	9/02
	 
	 	 	 	 	 	 	 	 
	11
	 	Delivery of Table #2	 	$	[*]	 	 	2/02
	 
	 	 	 	 	 	 	 	 
	12
	 	Delivery of Table #3	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	13
	 	Delivery of Gantry #1	 	$	[*]	 	 	3/02
	 
	 	 	 	 	 	 	 	 
	14
	 	Delivery of Gantry #2	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	15
	 	Delivery of Gantry #3	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	$	[*]	 	 	 

1

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Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03

Exhibit 2: Milestones/Payments

II. Extension #1 — Power Distribution Units

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	16
	 	Upon Agreement of PDU Extension:	 	 	 	 	 	 
	 
	 	• PDU NRE #1	 	$	[*]	 	 	12/01
	 
	 	 	 	 	 	 	 	 
	17
	 	Upon Delivery of PDU # 1:	 	 	 	 	 	 
	 
	 	• PDU NRE #2	 	$	[*]	 	 	4/02
	 
	 	• PDU #1	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	18
	 	Upon Regulatory Approval:	 	 	 	 	 	 
	 
	 	• PDU NRE #3	 	$	[*]	 	 	9/02
	 
	 	 	 	 	 	 	 	 
	19
	 	Upon Delivery of PDU #2	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	20
	 	Upon Delivery of PDU #3	 	$	[*]	 	 	9/02
	 
	 	 	 	 	 	 	 	 
	21
	 	Upon Delivery of PDU #4	 	$	[*]	 	 	11/02
	 
	 	 	 	 	 	 	 	 
	22
	 	Upon Delivery of PDU #5	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	23
	 	Upon Delivery of PDU #6	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	24
	 	Upon Delivery of PDU #7	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	25
	 	Upon Delivery of PDU #8	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	26
	 	Upon Delivery of PDU #9	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	27
	 	Upon Delivery of PDU #10	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	$	[*]	 	 	 

III. Extension #2 — Disk Casting for Test Bed

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	28
	 	Disk Casting for Test Bed	 	 	[*]	 	 	1/02
	 
	 	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	 	[*]	 	 	 

2

Table of Contents

Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03

Exhibit 2: Milestones/Payments

IV. Extension #3 — Computers

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	29
	 	Upon Agreement of Computers Extension:	 	 	 	 	 	 
	 
	 	•   Computer Hardware NRE # 1	 	$	[*]	 	 	1/02
	 
	 	•   Computer Software NRE #1	 	$	[*]	 	 	1/02
	 
	 	 	 	 	 	 	 	 
	30
	 	Upon Partial Delivery of Development Computer Set #1	 	$	[*]	 	 	12/01
	 
	 	 	 	 	 	 	 	 
	31
	 	Upon Completion of Development Computer Set #1:	 	 	 	 	 	 
	 
	 	•   Prototype OBC	 	 	 	 	 	3/02
	 
	 	•   Prototype STC	 	$	[*]	 	 	8/02
	 
	 	•   Computer Hardware NRE #2	 	$	[*]	 	 	4/02
	 
	 	 	 	 	 	 	 	 
	32
	 	Upon Completion of Software
Training Workshops:	 	 	 	 	 	 
	 
	 	•   Computer Software NRE #2	 	$	[*]	 	 	3/02
	 
	 	 	 	 	 	 	 	 
	33
	 	Upon Delivery of Computer Set #2:	 	 	 	 	 	 
	 
	 	•   Computer Set #2	 	$	[*]	 	 	5/02
	 
	 	•   Rx/PTM #1 Credit (See Milestone # 6)	 	$	[*]	 	 	5/02
	 
	 	•   Computer Hardware NRE #3	 	$	[*]	 	 	5/02
	 
	 	 	 	 	 	 	 	 
	34
	 	Upon Delivery of Computer Set #3	 	 	 	 	 	 
	 
	 	•   Computer Set #3	 	$	[*]	 	 	5/02
	 
	 	•   Rx/PTM #2
Credit (See Milestone #8)	 	$	[*]	 	 	5/02
	 
	 	 	 	 	 	 	 	 
	35
	 	Upon Delivery of Computer Set #4	 	 	 	 	 	 
	 
	 	•   Computer Set #4	 	$	[*]	 	 	9/02
	 
	 	•   Rx/PTM #3 Credit (See Milestone # 10)	 	$	[*]	 	 	9/02
	 
	 	 	 	 	 	 	 	 
	36
	 	Upon Delivery of Computer Set #5	 	$	[*]	 	 	11/02
	37
	 	Upon Delivery of Computer Set #6	 	$	[*]	 	 	12/02
	38
	 	Upon Delivery of Computer Set #7	 	$	[*]	 	 	 
	39
	 	Upon Delivery of Computer Set #8	 	$	[*]	 	 	 
	40
	 	Upon Delivery of Computer Set #9	 	$	[*]	 	 	 
	41
	 	Upon Delivery of Computer Set #10	 	$	[*]	 	 	 
	42
	 	Upon Completion of Computer Software Support	 	 	 	 	 	 
	 
	 	•   Computer Software NRE #3	 	$	[*]	 	 	10/02
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	Subtotal	 	$	[*]	 	 	 

3

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Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03 

Exhibit 2: Milestones/Payments

V.
Extension #4 — Additional Gantries, Tables, and DAS’s

	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	Date Billed
	 
	 	 	 	 	 	 
	43
	 	Delivery of Gantry #4	 	$[*]	 	9/02
	 
	 	 	 	 	 	 
	44
	 	Delivery of Table #4	 	$[*]	 	11/02
	 
	 	 	 	 	 	 
	45
	 	Delivery of DAS #4	 	$[*]	 	11/02
	 
	 	 	 	 	 	 
	46
	 	Delivery of Gantry #5	 	$[*]	 	9/02
	 
	 	 	 	 	 	 
	47
	 	Delivery of Table #5	 	$[*]	 	 
	 
	 	 	 	 	 	 
	48
	 	Delivery of DAS #5	 	$[*]	 	12/02
	 
	 	 	 	 	 	 
	49
	 	Delivery of Gantry #6	 	$[*]	 	11/02
	 
	 	 	 	 	 	 
	50
	 	Delivery of Table #6	 	$[*]	 	 
	 
	 	 	 	 	 	 
	51
	 	Delivery of DAS #6	 	$[*]	 	 
	 
	 	 	 	 	 	 
	52
	 	Delivery of Gantry #7	 	$[*]	 	12/02
	 
	 	 	 	 	 	 
	53
	 	Delivery of Table #7	 	$[*]	 	 
	 
	 	 	 	 	 	 
	54
	 	Delivery of DAS #7	 	$[*]	 	 
	 
	 	 	 	 	 	 
	55
	 	Delivery of Gantry #8	 	$[*]	 	 
	 
	 	 	 	 	 	 
	56
	 	Delivery of Table #8	 	$[*]	 	 
	 
	 	 	 	 	 	 
	57
	 	Delivery of DAS #8	 	$[*]	 	 
	 
	 	 	 	 	 	 
	58
	 	Delivery of Gantry #9	 	$[*]	 	 
	 
	 	 	 	 	 	 
	59
	 	Delivery of Table #9	 	$[*]	 	 
	 
	 	 	 	 	 	 
	60
	 	Delivery of DAS #9	 	$[*]	 	 
	 
	 	 	 	 	 
	 
	 	 	 	 	 	 
	 
	 	Subtotal	 	$[*]	 	 

4

Table of Contents

Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03

Exhibit 2: Milestones/Payments

VI. Extension #5 — Partial System Development and Manufacture

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	61
	 	Upon Agreement	 	 	 	 	 	 
	 
	 	• System NRE #1	 	$	[*]	 	 	3/02
	 
	 	 	 	 	 	 	 	 
	62
	 	System Design Review	 	 	 	 	 	 
	 
	 	• System NRE #2	 	$	[*]	 	 	7/02
	 
	 	 	 	 	 	 	 	 
	63
	 	Completion of First 3 Man Months Software Development	 	 	 	 	 	 
	 
	 	• System Software NRE #1	 	$	[*]	 	 	5/02
	 
	 	 	 	 	 	 	 	 
	64
	 	Completion of Second 3 Man Months Software Development	 	 	 	 	 	 
	 
	 	• System Software NRE #2	 	$	[*]	 	 	7/02
	 
	 	 	 	 	 	 	 	 
	65
	 	Assembly of Gantry Subsystem #1 at Analogic	 	 	 	 	 	 
	 
	 	• System NRE #3	 	$	[*]	 	 	10/02
	 
	 	 	 	 	 	 	 	 
	66
	 	Completion of Third 3 Man Months Software Development	 	 	 	 	 	 
	 
	 	• System Software NRE #3	 	$	[*]	 	 	10/02
	 
	 	 	 	 	 	 	 	 
	67
	 	Test Bed Hardware Integration of Analogic and TomoTherapy	 	 	 	 	 	 
	 
	 	Subsystems	 	 	 	 	 	 
	 
	 	• System NRE #4	 	$	[*]	 	 	10/02
	 
	 	 	 	 	 	 	 	 
	68
	 	Delivery of Integrated Gantry Subsystem #1	 	$	[*]	 	 	9/02
	69
	 	Delivery of Integrated Gantry Subsystem #2	 	$	[*]	 	 	11/02
	70
	 	Delivery of Integrated Gantry Subsystem #3	 	$	[*]	 	 	12/02
	71
	 	Delivery of Integrated Gantry Subsystem #4	 	$	[*]	 	 	 
	72
	 	Delivery of Integrated Gantry Subsystem #5	 	$	[*]	 	 	 
	73
	 	Delivery of Integrated Gantry Subsystem #6	 	$	[*]	 	 	 
	74
	 	Delivery of Integrated Gantry Subsystem #7	 	$	[*]	 	 	 
	75
	 	Delivery of Integrated Gantry Subsystem #8	 	$	[*]	 	 	 
	76
	 	Delivery of Integrated Gantry Subsystem #9	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	$	[*]	 	 	 

5

Table of Contents

Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03

Exhibit 2: Milestones/Payments

VII. Extension #6 — Disk Casting Machining Modifications

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	77
	 	Lot Charge (9 Disks)	 	$	[*]	 	 	10/02
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	$	[*]	 	 	 

VIII. Extension #7 — Add Pneumatic Seal to Bearings

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	78
	 	Delivery of Prototype Bearing #1	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	79
	 	Delivery of Prototype Bearing #2	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	$	[*]	 	 	 

IX. Extension #8 — 100 VxWorks Target Licenses

	 	 	 	 	 	 	 	 	 
	Milestone #	 	Description	 	Payment Amount	 	 	Date Billed
	 
	 	 	 	 	 	 	 	 
	80
	 	15 Target Licenses (Computer Sets #1 - #5)	 	$	[*]	 	 	10/02
	 
	 	 	 	 	 	 	 	 
	81
	 	3 Target Licenses (Computer Set #6)	 	$	[*]	 	 	12/02
	 
	 	 	 	 	 	 	 	 
	82
	 	3 Target Licenses (Computer Set #7)	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	83
	 	3 Target Licenses (Computer Set #8)	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	84
	 	3 Target Licenses (Computer Set #9)	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	85
	 	3 Target Licenses (Computer Set #10)	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 	 
	86
	 	70 Target Licenses (@ $[*]/license)	 	$	[*]	 	 	 
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	                      Subtotal	 	$	[*]	 	 	 

6

Table of Contents

Analogic-TomoTherapy Development and OEM Supply

Agreement 1/14/03

Exhibit 2: Milestones/Payments

X.     Extension #9 — Gantry Power Interface Upgrade Kits

	 	 	 	 	 	 	 	 	 
	 	 	 	 	Payment	 	 	Date
	Milestone #	 	Description	 	Amount	 	 	Billed
	 
	 	 	 	 	 	 	 	 
	87
	 	Gantry Power Interface Kit #1	 	$	[*]	 	 	12/02
	 
	 	 	 	 	 	 	 	 
	88
	 	Gantry Power Interface Kit #2	 	$	[*]	 	 	12/02
	 
	 	 	 	 	 	 	 	 
	89
	 	15:1 Gear Reducer	 	$	[*]	 	 	12/02
	 
	 	 	 	 	 	 	 	 
	90
	 	NRE	 	$	[*]	 	 	12/02
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	Subtotal
	 	$	[*]	 	 	 

7

Table of Contents

TOMOTHERAPY SPARES

	 	 	 	 	 	 	 
	Part #	 	Description	 	Quantity	 	Price (each)
	10-42956-01

	 	Recon Computer Assy
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60165-01

	 	PDU Control Board 00B
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-41954-01

	 	Base Control Comptr Assy
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60204-01

	 	MLC Control Board
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60274-01

	 	Sensor Bd Cal Assy
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60274-02

	 	Sensor Bd, Tick
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60019-01

	 	Gang Bd Assy Tested (8)
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60113-01

	 	Gang Bd Offset 2 Assy
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60112-01

	 	Gang Bd Offset 1 Assy
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60276-01

	 	Modulator Interface Bd 00D
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-60399-01

	 	Aux Input Bd Rev 1
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-44771-01

	 	Disk Control Assy
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-27160-01

	 	RTS DAS
	 	[*]
	 	$[*]
	 
	 	 	 	 	 	 
	10-42363-01

	 	Table Control Assy
	 	[*]
	 	$[*]

Notes:

Spares available until forecast from TomoTherapy and production ramp.

 

Table of Contents

Exhibit 3 — Production System Pricing (24 January 2003)

System is defined as of 12 August 2002 to include:

Gantry

Table

DAS

Computers (2- control and 1- reconstruction ) PDU

Commercial Components Cables

PCB’s, Chassis, Mounting Hardware

*System Assembly/ Integration / Test

* Does not include:

LINAC, Magnetron, SSM, HVPS

MLC and Jaws

Xenon Detectors

Rotary Union

System Covers

System workstation

System quantity pricing is based upon a quantity ordered and delivery accepted within the following
12 month period. This Production Systems Pricing will commence with the shipment of a production
HI-ART-II system (system #11) and will apply to all production systems.

Production System Pricing

	 	 	 	 	 
	1-19	 	20-49	 	50- UP
	$[*]
	 	$[*]
	 	$[*]

Pre-production System Pricing

Pilot systems #1 thru #10 = $[*] each

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00121-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00121-of-00352.parquet"}]]