Document:

exv10w11

 

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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	 	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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	 	 	 	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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	 	 	 	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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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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27 JANUARY 2002

	 	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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27 JANUARY 2002

	 	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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27 JANUARY 2002

	 	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 $[  *  ] 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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27 JANUARY 2002

	 	 	 	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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27 JANUARY 2002

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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27 JANUARY 2002

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
arbitrate.

 

 

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27 JANUARY 2002

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
Proprietary Technology, Development Information, and ANALOGIC

 

 

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27 JANUARY 2002

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 2/5/03exv10w12

 

Exhibit 10.12

SIEMENS

MANUFACTURE AND SUPPLY AGREEMENT

          This Agreement made as of this 14” day of November 2003 by and between Siemens
Medical Solutions, USA, Inc., acting through and on behalf of its Oncology Care Systems
Group having a business address at 4040 Nelson Avenue, Concord,
CA 94520 (“Seller”)
and Tomo Therapy, Incorporated, having a business address at 1240 Deming Way, Madison,
WI 53717 (“Buyer”).

W I T N E S S E T H :

          WHEREAS, Seller has experience and expertise in the manufacturing, and/or support of
RF Systems Assemblies; and

          WHEREAS, Buyer wishes to have Seller use its expertise to continue manufacturing
and/or supporting the products (herein collectively referred to as “Products”) listed in Exhibit A
for the period specified in this Agreement; and

          NOW, THEREFORE, for good and valuable consideration, the adequacy of which is
hereby acknowledge, the Seller and Buyer do hereby agree to covenant and promise the following:

	 	1.	 	SCOPE

Commencing on the effective date of this Agreement Buyer shall provide Seller
with a twelve (12) month rolling forecast, which shall be updated on a monthly basis.
The initial forecast will be accompanied by a firm purchase order for the first six (6)
months and a projection of orders for the next six (6) months, subject to the lead time
stated in Exhibit B. In accordance with this Agreement, Buyer shall issue a
purchase order to Seller by no later than November 30, 2003. Seller will provide the
personnel, technical services and facilities necessary in order to manufacture the
Products for Buyer.

Neither party shall be deemed to be in default of this Agreement if prevented from
performing any obligation hereunder for any reason beyond its reasonable control
including, without limitation, governmental laws and regulations, terrorists acts, Acts
of God or the public, calamities, floods, and storms.

	 	2.	 	PURCHASE ORDER PLACEMENT

Every three (3) months, thereafter, firm purchase orders shall be issued on
the first of each rolling month for Products to be delivered in the third full calendar
month, following the month in which Seller receives the purchase order. Buyer may delay
delivery by as much as 30 days, provided such delay notice is delivered to Seller not
less than 90 days prior to the originally scheduled delivery date.

As a condition of this Agreement, Buyer agrees to a firm minimum buy procurement of
[  *  ] sets of Accelerator Assembly, part number
[  *  ] for each of the two years
commencing with the effective date of this Agreement. Said purchase orders shall be
binding to the parties and any successors or assigns. Notwithstanding the above, the
Buyer will provide the purchasing forecast for Seller’s planning purpose only.

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	1
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

 

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.

 

 

SIEMENS

Seller shall formally acknowledge Buyer’s purchase orders and provide a
confirmation of delivery dates (lead time is 90 days). Seller shall maintain as necessary,
an appropriate level of IS0 certification and compliance to IS0
9001. Seller further warrants that all Products sold to Buyer under this Agreement
comply with the requirements of the U.S. Food and Drug Administration (“FDA”) and the
FDA’s Good Manufacturing Practices (“GMP”) with respect to the manufacture, package,
assembly and testing for the Products

Seller shall formally notify Buyer of any Product changes that affects form fit or
function (class one).

	 	3.	 	PACKAGING

Packaging of the Products shall be in a manner adequate to ensure undamaged arrival
at Buyer’s business address, when transported by airplane, ship, truck or railroad. All
deliveries shall be accompanied by a shipping list.

	 	4.	 	TERM

The term of this Agreement is two (2) years from date of signature.
Seller may elect to automatically extend this Agreement for additional one (1) year
increments upon written Amendment to this Agreement signed by both parties.

	 	5.	 	PRICING

The pricing for Products shall be in accordance with Exhibit A and shall be
valid for a period of one (1) year following the effective date of this Agreement. At the
end of each year, Seller will review prices for an increase not to
exceed [  *  ] of then
current price.

Excepting Seller’s inability to deliver, if at the end of the first 12
months of this Agreement, the Buyer is unable to meet the minimum purchase
quantity of [  *  ] sets of Accelerator Assembly stated in Exhibit B, then Seller
will review prices for an increase not to exceed an additional 10%.

	 	6.	 	PAYMENT TERMS

The Payment terms are net 30 days after the receipt of invoice from Seller. All
Products shipped are FOB Concord, CA.

	 	7.	 	WARRANTY

All Products provided under this Agreement shall be in accordance with the
Seller’s specifications. Except for [  *  ], which is warranted for one (1)
year from the date of delivery, Seller warrants all other Products to be free from defects
in materials and workmanship for a period of six (6) months from the date of delivery.

Seller
shall only perform an inspection and test of returned Accelerator
Assembly Product part number [  *  ] to confirm that there is a defect during warranty period. Seller at
its option will repair or replace defective Product within 30 business days after receipt
at Seller’s facility.

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	2
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

 

 

SIEMENS

Buyer’s remedy is contingent on (1) prompt written notification of the defect;
(2) the cause of the defect not being the result of misuse, accident, neglect, alteration,
improper testing, storage, installation or negligence on the part of the Buyer; and (3)
return of the Products to Buyer’s manufacturing location with shipment and in-transit loss
or damage at the risk and expense of the Buyer. Such repair, replacement or credit shall
constitute fulfillment of all liability of Buyer to Seller whether based in contract,
tort, and indemnity or otherwise.

In
the event, Seller is unable to confirm a failure for an
Accelerator Assembly Product, which has been returned to Seller under warranty, Seller shall invoice
Buyer at the current manufacturing rate of [  *  ], at an amount not to exceed the
current labor value of the Product.

EXCEPT AS EXPRESSLY SET FORTH IN
THE PRECEDING SENTENCES AND/OR IN SPECIFICATIONS,
SELLER MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH
RESPECT TO THE PRODUCTS.

	 	8.	 	LIMITATION OF LIABILITY

NOTWITHSTANDING ANYTHING TO THE
CONTRARY CONTAINED OR CONSTRUED TO BE CONTAINED
IN THIS AGREEMENT, EXCEPT FOR NEGLIGENCE OR WILLFUL MISCONDUCT RESULTING IN BODILY INJURY,
SELLER SHALL NOT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY OR
CONSEQUENTIAL DAMAGES, HOWEVER CAUSED, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
SELLER’S LIABILITY TO THE OTHER SHALL NOT EXCEED THE SUMS PAID BY BUYER TO SELLER UNDER
THIS AGREEMENT. BUYER ACKNOWLEDGES THAT THESE LIMITATIONS ON POTENTIAL LIABILITIES WERE AN
ESSENTIAL ELEMENT IN SETTING CONSIDERATION UNDER THIS AGREEMENT.

	 	9.	 	TERMINATION

If either party materially breaches its obligations in this Agreement, the other
party may terminate this Agreement by giving not less than 30 days notice to the other
party. Termination will not occur if the defaulting party, within such thirty (30) day
period, remedies such breach to the reasonable satisfaction of the non-defaulting party.

This Agreement may be terminated immediately by the other 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.

	 	10.	 	EXPORT

Each party agrees that it will not knowingly (i) export or re-export, directly or
indirectly, any technical data (as defined by the U.S. Export Administration
Regulations), including software received from the other under this Agreement, (ii)
disclose such technical data for

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	3
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

 

 

SIEMENS

use in, or (iii) export or re-export, directly or indirectly, any direct
product of such technical data, including software, to any destination to which such export
or re-export is restricted or prohibited by U.S. or non-U.S. law without obtaining prior
authorization from U.S. Department of State and other competent government authorities to
the extent required by those laws. This clause shall survive termination or cancellation of
this Agreement.

	 	11.	 	INDEMNIFICATION

	 	a)	 	Bodily injury, Disability or Death

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 attorney’s fees, arising
from claims made against or liability imposed upon the other, by a court of competent
jurisdiction as the results of claims alleging personal injury, disability, death or
property damage or any form or type or wrongdoing or loss arising from either party’s
failure to perform its respective obligations hereunder. In Buyer’s case, such
indemnity obligations shall also apply to claims arising out of or in connection with
Buyer’s assembly and resale of the Products, including without limitation, Buyer’s burden of
customer training, service and support, its representations made in the course of reselling
or distributing the Products, and its distribution of related materials and literature

For Buyer, indemnification for the bodily injury, disability, death or property damage
shall be limited to the sum of [  *  ] in any twelve (12) month period, commencing on
October lst of any year. For Seller, indemnification shall be limited to the cumulative
total value of the Products purchase under the life of this Agreement. Notwithstanding the
aforementioned, under no circumstances, excepting gross negligence or willful misconduct,
will Seller’s liability exceed the cumulative total value of the Products purchased under
the life of this Agreement.

In the event that a claim is made against a Party seeking indemnification for bodily
injury disability or death, 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.

	 	b)	 	Intellectual Property Infringement

The Seller agrees, at its cost and expense, to defend any claim, suit or legal proceeding
asserted or brought against the Buyer or the Buyer’s customers, that any Product, or the use
thereof, infringes any United States patent, copyright or other intellectual property rights of a
third party, provided the Seller is notified promptly in writing of such claim, suit or legal
proceeding, and given full and complete authority to defend the same, and given such information as
the Buyer may have regarding the same as may be reasonably required for the defense of the same.
The Seller shall pay all damages, awards and costs, awarded. The Seller shall not be responsible
for any settlement negotiated and agreed to by the Buyer or any other party without the consent of
the Seller. The Seller shall have the right, at its own election and at its own expense, to either
(a) procure for the Buyer the right to continue to distribute and use such Products or part or
component, thereof or (b) modify the same so that it becomes non-infringing provided
that the functionality, level of performance, features and quality thereof are not affected, or, if
neither of the foregoing alternatives is commercially

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	4
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

 

 

SIEMENS

reasonable, the Seller may repurchase such Product (the repurchase price is to
be based on the original price paid by the Buyer less depreciation on a straight line
basis over five (5) years, commencing with the date of installation and start
up of such Product). The Buyer shall have the right, at its own election, to return any
such affected Product to the Seller for refund of the purchase price as set forth above,
and to cancel any outstanding Orders or further deliveries of the Product, without any
liability to the Seller with respect thereto.

Notwithstanding the foregoing, the Seller shall not have any liability to the Buyer
under the provision of Section 7 (b), that (i) is based upon the interconnection and/or the
use of a Product, or part thereof, in combination with products or other devices outside
the scope of this Agreement without the prior written consent of the Seller, which are not
made by the Seller whether or not supplied hereunder, or (ii) for use in any
manner for which the Product, or part thereof, was not designed or created. Also, the Buyer
shall hold the Seller harmless against any expense, judgment or loss for infringement of
any patent or copyright that results from the Seller’s compliance with the incorporation of
designs specifications furnished by the Buyer. In addition, to the extent it is empowered,
the Seller agrees to pass on to the Buyer patent infringement indemnification received from
suppliers to the Seller of the Products or part thereof not designed by or for the Seller
but furnished hereunder.

The foregoing states the entire liability of the Parties with respect to infringement
of intellectual property rights by the Products or any part thereof.

	 	c)	 	Product Liability Insurance

Buyer covenants that it will maintain product liability insurance adequate to fulfill
the indemnification obligation hereunder in each such 12-month period commencing on October
1st of each year. Seller is self-insured and covenants that it has sufficient capital to
meet all obligations hereunder.

	 	12.	 	CONFIDENTIALITY

During
the term of this Agreement and for five (5) years after the latter of
either the termination of this Agreement or the termination of the last Statement of Work
under this Agreement, each party shall use the same efforts it uses to protect its own
confidential information (but in any event, no less than reasonable efforts to prevent its
disclosure) to hold in strict confidence and to require its personnel to hold in strict
confidence and not disclose to any third party without the prior written consent of the
disclosing party, and not use in any manner except in accordance with the terms of this
Agreement, any confidential business or technical information of the other party in its
possession which is related to any Product or Statement of Work or any confidential
business or technical proprietary information obtained from the other party (or any of its
Affiliates) in connection with the transactions contemplated hereunder.

Such confidential information specifically may include, without limitation, all
engineering drawings, specifications and other technical documentation, any proposed design
and specifications for future products and products in development, marketing plans, costs
and pricing information, and all third party information required to be maintained in
confidence. Promptly following termination of this Agreement or upon the request by or for
the disclosing party, the receiving party shall surrender to the disclosing party or
destroy all

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	 
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

5

 

SIEMENS

materials remaining in its possession containing any such confidential
information including all copies, extracts, or transcriptions, regardless of media.

For purposes of this Agreement and the Products and Statement of Work, information shall
not be deemed confidential:

	 	a)	 	if such information is generally available from public sources other
than as a result of the breach of this Agreement
	 
	 	b)	 	if such information is
received from a third party not under any obligation to keep such information confidential
	 
	 	c)	 	if the recipient can demonstrate that such information was independently
developed by the recipient without use of any confidential information of the other party
or its Affiliates; and
	 
	 	d)	 	if such information is marketing material such as
catalogs or leaflets distributed to third parties as a part of sales and promotions.

Neither party shall be liable to the other for a breach of these confidentiality
obligations to the extent it is required by law or any governmental body to disclose any
confidential information of the other party; provided, however, unless otherwise required
by such governmental body or such law, the party providing such information to such
governmental body or disclosing the same pursuant to requirement of law shall first notify
the other party so as to enable the other party opportunity to take steps it deems
appropriate to protect its confidential or proprietary information.

	 	13.	 	GOVERNING LAW

This Agreement is governed by and construed in accordance with the laws of the
State of California, USA, without regards to conflict of law provisions thereof. Assignment
of this Agreement may be made only upon the written consent of both parties; provided,
however, that Seller may assign this Agreement to any parent, affiliate or subsidiary
corporation upon notice to Buyer. Any attempted assignment or transfer of any of the rights,
duties or obligations of this Agreement without the prior written consent of either party
shall be void. If consent is given, this Agreement shall be binding upon and
inure to the benefit of the assigns.

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	6
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

 

 

SIEMENS

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives as of the date first written above.

	 	 	 	 	 	 	 	 	 
	Siemens Medical Solutions USA, Inc.	 	 	 	TomoTherapy Incorporated
	Oncology Care Systems Division	 	 	 	1240 Deming Way
	Concord, CA 94520	 	 	 	Madison, WI 53717
	“Seller”	 	 	 	“Buyer”
	 
	 	 	 	 	 	 	 	 
	By: Ajit Singh, Ph.D.	 	 	 	By: Mr. John Barni
	Title: President	 	 	 	Title: CEO
	 
	 	 	 	 	 	 	 	 
	Signature:

	 	/s/ Ajit Singh
	 	 	 	Signature:
	 	/s/ John Barni
	 

	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Date:

	 	11/17/03
	 	 	 	Date:
	 	11/18/03
	 

	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	By: Mr. Bernd Haetzel	 	 	 	 	 	 
	Title: Vice-President Finance and Administration	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Signature:

	 	/s/ Bernd Haetzel	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Date:

	 	11-13-03	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 

Siemens Medical Solutions USA, Inc.

									
	 	 	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue

Concord, CA 94520
	 	7
	 	Tel: (925) 246-8200

Fax: (925) 246-8284
	 	ww.siemensmedical.com/oncology

 

 

SIEMENS

COVER PAGE

AMENDMENT THREE

to

Manufacturing and Supply Agreement

MSA-50047-WMG

Between

SIEMENS MEDICAL SOLUTIONS USA INC.

Oncology Care Systems

4040 Nelson Avenue

Concord, CA 94520

And

TomoTherapy, Inc.

1240 Deming Way

Madison, WI 53717

Siemens Medical Solutions USA, Inc.

							
	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 
	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

 

 

	 	 	 
	SIEMENS

	 	MSA- 50047-WMG

Amendment 03

This Amendment Three to the Manufacturing and Supply Agreement dated November 14,
2003 between Siemens Medical Solutions USA, Inc. and TomoTherapy, Inc. is hereby entered
into retroactively as of October 1, 2005.

The parties hereto agree to the following modifications:

1. Section 2. Purchase Order Placement

DELETE
in its entirety and REPLACE in lieu thereof the following:

“Buyer will provide Seller an annual blanket purchase order for the Products. Buyer may
delay delivery by as much as 30 days, provided such delay notice is delivered to
Seller not less than 60 days prior to the originally scheduled delivery date.

As
a condition of this Agreement, Buyer agrees to take delivery of a
minimum of [  *  ] Accelerator
Assemblies per year, comprised of either part number [  *  ] or part number [  *  ], commencing with the effective date of this
Agreement. Said minimum shall be binding upon the parties and any their successors or assigns.
Notwithstanding the above, the Buyer will provide the purchasing forecast for Seller’s planning
purpose only.

Seller shall formally acknowledge Buyer’s purchase orders by fax or email and provide a
confirmation of delivery dates.

All products shall be delivered in full on or 5 days before the scheduled due date.

2. Section 4. Term

DELETE
in its entirety and REPLACE in lieu thereof the following:

“This
Agreement shall remain in full force and effect until October 1,
2010.
This Agreement shall be automatically renewed for additional renewal terms of twelve (12)
months each, unless either Party gives the other Party at least one (1) year prior written
notice of election to terminate this Agreement effective at the end of the then current term.
In the event that the Seller elects to terminate this Agreement in accordance with the
above terms, the Buyer shall have the right to place a “last time” Purchase Order no
later than 90 days prior to the termination of this Agreement to provide Buyer with
sufficient quantity to meet the Buyer’s expected product needs for the one (1) year period
immediately following termination of this Agreement. The Parties will negotiate in good faith
the delivery schedule for each product covered by such “last time” Purchase Order, but it is
presumed that Buyer will take delivery of those products equally over the first nine months
after termination of the Agreement.

Siemens Medical Solutions USA, Inc.

							
	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 
	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

2

 

	 	 	 
	SIEMENS

	 	MSA- 50047-WMG

Amendment 03

3. Section 5. Pricing

DELETE Section 5 in its entirety and REPLACE in lieu thereof the following:

“The pricing for Products shall be in accordance with Exhibit B and shall be valid
until September 30, 2010.

4. Section 6. Payment Terms

DELETE Section 6 in its entirety and REPLACE in lieu thereof the following:

“Delivery is F.O.B. or F.C.A. origin (INCO Terms 2000), whichever is
applicable. Buyer shall specify the carrier and its account number with carrier by so
indicating on the face of its purchase order.”

5. Section 7. WARRANTY

DELETE Section 7 in its entirety and REPLACE in lieu thereof the following:

“Seller warrants maintaining as necessary, an appropriate level of IS0
certification and compliance to IS0 13485. Seller further warrants that all
Products sold to Buyer under this Agreement comply with the requirements of the U.S. Food and
Drug Administration (“FDA”) and the FDA’s Good Manufacturing Practices (“GMP”) with
respect to the manufacture, package, assembly and testing for the Products and that all Products
provided under this Agreement shall be in accordance with the Seller’s specifications.

Except for part numbers [  *  ] and [  *  ], which are warranted for one (1) year from the
date of delivery, Seller warrants that all other Products will be free from defects in materials
and workmanship for a period of six (6) months from the date of delivery.

Seller
shall only perform an inspection and test of returned Accelerator
Assembly Products [  *  ] to confirm that there is a defect during warranty
period. Seller at its option will repair or replace defective Product within 30 business days
after receipt at Seller’s facility. Though not obligated to do so, Seller at its sole unilateral
option, may elect to conduct inspection and test on other Products under this Agreement.

Buyer’s remedy is contingent upon (1) prompt written notification of the defect; (2) the
cause of the defect not being the result of misuse, accident, neglect, alteration, improper
testing, storage, installation or negligence on the part of the Buyer; and (3) return of the
Products to Buyer’s manufacturing location with shipment and in-transit loss or damage at the
risk and expense of the Buyer. Such repair, replacement or credit shall constitute fulfillment
of all liability of Buyer to Seller whether based in contract, tort, and indemnity or
otherwise.

If an Accelerator Assembly Product has been returned to Seller under warranty
and Seller is unable to confirm a failure for it after Buyer has had a full opportunity to
verify the cause of the failure, explain the same to Seller, and Seller has conducted tests
necessary to confirm the failure, Seller shall invoice Buyer at the manufacturing rate of
[  *  ], at an amount not

Siemens Medical Solutions USA, Inc.

							
	 	 	 	 	 	 	 
	Oncology Care Systems Group
	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 
	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

3

 

			
	SIEMENS
	 	MSA-50047-WMG
Amendment 03

	 	 	to exceed the equivalent of [  *  ]. Seller must obtain a purchase order from
the Buyer for testing beyond the amount of [  *  ].
	 
	 	 	EXCEPT AS EXPRESSLY SET FORTH IN THE PRECEDING SENTENCES AND/OR IN SPECIFICATIONS, SELLER
MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO
THE PRODUCTS.”

6.
Section 11. INDEMNIFICATION

DELETE the second paragraph in Section 11 and REPLACE in lieu thereof the
following:

	 	 	“Each party’s maximum liability to the other party relating to claims for property damage shall
be limited to a maximum of [  *  ] for performance under this Agreement.”

7.
Section 12. CONFIDENTIALITY

DELETE Section 12 and REPLACE in lieu thereof the following:

	 	 	“During the term of this Agreement and for five (5) years after the latter of
either the termination of this Agreement or the termination of the last Statement of Work under
this Agreement, each party shall use the same efforts it uses to protect its own confidential
information (but in any event, no less than reasonable efforts to prevent its disclosure) to
hold in strict confidence and to require its personnel to hold in strict confidence and not
disclose to (1) any employee, director, or agent that does not need to know such information for
the purpose of carrying out this Agreement or (2) any third party without the prior written
consent of the disclosing party, and not use in any manner except for purposes of carrying out
this Agreement and otherwise in accordance with the terms of this Agreement, any confidential
information of the other party in its possession. Such confidential information specifically may
include, without limitation, all engineering drawings, specifications and other technical
documentation, any proposed design and specifications for future products and products in
development, marketing plans, costs and pricing information, all third party information
required to be maintained in confidence, and any other information that the
disclosing party has marked as confidential. Promptly following termination of this Agreement or
upon the request by or for the disclosing party, the receiving party shall surrender to the
disclosing party or destroy all materials remaining in its possession containing any such
confidential information including all copies, extracts, or transcriptions, regardless of media.
	 
	 	 	For purposes of this Agreement and the Products and Statement of Work, information shall not
be deemed confidential:

	 	a)	 	if such information is generally available from public sources other than as a result
of the breach of this Agreement;
	 
	 	b)	 	if such information is received from a third party not under any obligation
to keep such information confidential;

	 	 	 	 	 	 	 
	Siemens Medical Solutions USA, Inc.
	 
	 	 	 	 	 	 
	Oncology Care Systems Group

	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 

	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

4

 

			
	SIEMENS
	 	MSA-50047-WMG
Amendment 03

	 	c)	 	if the recipient can demonstrate that such information was independently
developed by the recipient without use of any confidential information of the other party
or its Affiliates; and
	 
	 	d)	 	if such information is marketing material such as catalogs or leaflets
distributed to third parties as a part of sales and promotions.

	 	 	Neither party shall be liable to the other for a breach of these confidentiality
obligations to the extent it is required by law or any governmental body to disclose any
confidential information of the other party; provided, however, unless otherwise required by
such governmental body or such law, the party providing such information to such governmental
body or disclosing the same pursuant to requirement of law shall first notify the other party
so as to enable the other party opportunity to take steps it deems appropriate to protect its
confidential or proprietary information.”

8. ADD: New Section 15. Notices

	 	 	“All contractual notices from one party to the other under this Agreement shall be
in writing and either personally delivered or sent via certified mail, (E-mail or other
electronic media are not acceptable), postage prepaid and return receipt requested to:

	 	 	 	 	 
	 

	 	Buyer:
	 	TomoTherapy, Inc.
	 

	 	 	 	1240 Deming Way
	 

	 	 	 	Madison, WI 53717
	 

	 	 	 	ATTENTION: Bob Evensen
	 
	 	 	 	 
	 

	 	Seller:
	 	Siemens Medical Solutions USA, Inc.
	 

	 	 	 	Oncology Care Group
	 

	 	 	 	4040 Nelson Avenue
	 

	 	 	 	Concord, CA 94520
	 

	 	 	 	ATTENTION: Manager, Strategic Procurement

	 	 	or to such other person or places as either party may designate from time
to time by notice hereunder. Such notices shall be deemed effective upon personal delivery
or deposit in the mails in accordance herewith.”

9. ADD: New Section 16. Conflicts with Other Terms and Conditions

	 	 	“This Agreement contains all of the terms and conditions as they relate to the
relationship between Buyer and Seller. Any terms and conditions, other than price, quantity,
and shipping instructions, which may be specified on Buyer’s purchase order or on any Buyer’s
Order Acknowledgement Form, are null and void unless expressly agreed upon in writing by
Seller’s representative responsible for Contract Administration.”

	 	 	 	 	 	 	 
	Siemens Medical Solutions USA, Inc.
	 
	 	 	 	 	 	 
	Oncology Care Systems Group

	 	4040 Nelson Avenue
	 	Tel: (925)246-8200
	 	 
	 

	 	Concord, CA 94520
	 	Fax: (925)246-8284	 	www.siemensmedical.com/oncology

5

 

			
	SIEMENS
	 	MSA-50047-WMG
Amendment 03

10.
Exhibit A. Statement of Work (Performance Specification
Requirements)

     DELETE
in its entirety and REPLACE in lieu thereof the following Exhibit A:

STATEMENT OF WORK

(Performance Specification Requirement)

Product Documents: In addition to “Accelerator Tomo 6MV Design Specification
11.000207 Rev. E.”, which is the governing document for the
rectangular waveguides (OCS P/N: [  *  ]) and “Accelerator Tomo 6MV Design Specification 1 1.000236 Rev. A.”, which is the
governing document for the round waveguides (OCS P/N: [  *  ]); the following
Seller’s Product documents are hereby incorporated by reference.

	 	 	 
	Part Number	 	Description
	 
	 	 
	[  *  ]

	 	AFC ASSY, G39
	[  *  ]

	 	ACCELERATOR ASSY,TOMO 6V
	[  *  ]

	 	PWR SPL ASSY,ION PMP,12V-A20
	[  *  ]

	 	DRIVE ASSY-MAGN TUNER-M5
	[  *  ]

	 	DOSE CHAMBER ASSY
	[  *  ]

	 	RF CIRCULATOR ASSY,KD2-G36
	[  *  ]

	 	INJECTOR ASSY,ELECT-G45
	[  *  ]

	 	TARGET ASSY,MONO 6MV / PRIMART
	[  *  ]

	 	RF,DETECTOR MOUNT ‘N’
	[  *  ]

	 	ATTENUATOR,RF 20DB N 250 watts
	[  *  ]

	 	O-RING,BUNA-N 3.975-ID M4152TR
	[  *  ]

	 	ACCELERATOR ASSY, TOP TOMO
	[  *  ]

	 	TARGET, SPINNING TUNGSTEN

	 	 	 	 	 	 	 
	Siemens Medical Solutions USA, Inc.
	 
	 	 	 	 	 	 
	Oncology Care Systems Group

	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 

	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

6

 

			
	SIEMENS
	 	MSA-50047-WMG
Amendment 03

11. Exhibit B — Product Pricing

	 	 	DELETE in its entirety and REPLACE in lieu thereof the following Exhibit B:

EXHIBIT B

PRODUCT PRICING

	 	 	 	 	 	 	 	 	 	 	 	 	 
	PN	 	 	Description	 	Base Price	 	 	Lead Times	 
	 	[  *  ]	 	 	AFC ASSY, G39
	 	$	[  *  ]	 	 	60 days
	 	[  *  ]	 	 	ACCELERATOR ASSY, TOMO 6V
	 	$	[  *  ]	 	 	90 days
	 	[  *  ]	 	 	PWR SPL ASSY, ION PMP, 12V-A20
	 	$	[  *  ]	 	 	42 days
	 	[  *  ]	 	 	DRIVE ASSY-MAGN TUNER-M5
	 	$	[  *  ]	 	 	75 days
	 	[  *  ]	 	 	DOSE CHAMBER ASSY
	 	$	[  *  ]	 	 	120 days
	 	[  *  ]	 	 	RF CIRCULATOR ASSY, KD2-G36
	 	$	[  *  ]	 	 	75 days
	 	[  *  ]	 	 	INJECTOR ASSY, ELECT-G45
	 	$	[  *  ]	 	 	65 days
	 	[  *  ]	 	 	TARGET ASSY, MONO 6MV / PRIMART
	 	$	[  *  ]	 	 	90 days
	 	[  *  ]	 	 	RF,DETECTOR MOUNT ‘N’
	 	$	[  *  ]	 	 	60 days
	 	[  *  ]	 	 	ATTENUATOR, RF 20DB N 250 watts
	 	$	[  *  ]	 	 	60 days
	 	[  *  ]	 	 	0-RING,BUNA-N 3.975-ID M4152TR
	 	$	[  *  ]	 	 	60 days
	 	[  *  ]	 	 	ACCELERATOR ASSY, TOP TOM0
	 	$	[  *  ]	 	 	90 days
	 	[  *  ]	 	 	TARGET, SPINNING TUNGSTEN
	 	$	[  *  ]	 	 	90 days

	 	 	[  *  ]
	 
	 	 	Seller shall be entitled to the following break-point discounts on part numbers
[  *  ] and [  *  ] when a twelve (12) month non-cancelable purchase order is placed for the
following corresponding quantities. Each twelve (12) month period shall run from October 1st of
each year through September 30th of the following year.
	 
	 	 	The below stated discount break-points apply to all quantities stated on
the aforementioned twelve (12) month purchase order.

	 	 	 
	Discount	 	Quantities of PIN [  *  ] and/or [  *  ]
	[  *  ]%

	 	If yearly PO quantity is 65 units or less
	[  *  ]%

	 	If yearly PO quantity is between 66 and 85 units
	[  *  ]%

	 	If yearly PO quantity is between 86 and 100 units
	[  *  ]%

	 	If yearly PO quantity is between 101 and 130 units

The parties will negotiate in good faith the discount for quantities exceeding one hundred
thirty (130) units per year of part numbers [  *  ] and [  *  ].

	 	 	 	 	 	 	 
	Siemens Medical Solutions USA, Inc.
	 
	 	 	 	 	 	 
	Oncology Care Systems Group

	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 

	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

7

 

			
	SIEMENS
	 	MSA-50047-WMG
Amendment 03

     Except as modified herein, all other Terms and Conditions shall remain unchanged and apply hereto
in full force.

SIGNATURE PAGE

IN WITNESS WHEREOF, the parties have caused this Amendment One to be executed by their duly
authorized representatives as of the date written below.

	 	 	 
	Siemens Medical Solutions USA Inc.

	 	TomoTherapy, Inc.
	Oncology Care Systems Group
	 	 
	 
	 	 
	By:    Mr. Martin Wentzlik

	 	By:    Fred Robertson
	Title: Chief Fiancial Officer

	 	Title: CEO
	 
	 	 
	Signature:
/s/ Mr. Martin Wentzlik

	 	Signature: /s/ Fred Robertson
	 
	 	 
	Date: 01/11/06

	 	Date: January 23, 2006
	 
	 	 
	By:    Mr. Rolf Reimann
	 	 
	Title: VP, Plant Management
	 	 
	 
	 	 
	Signature: /s/ Rolf Reimann
	 	 
	 
	 	 
	Date: 01/11/2006
	 	 

	 	 	 	 	 	 	 
	Siemens Medical Solutions USA, Inc.
	 
	 	 	 	 	 	 
	Oncology Care Systems Group

	 	4040 Nelson Avenue
	 	Tel: (925) 246-8200
	 	www.siemensmedical.com/oncology
	 

	 	Concord, CA 94520
	 	Fax: (925) 246-8284	 	 

8

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