Exhibit 10.19
AMENDED AND RESTATED INTERNATIONAL DISTRIBUTOR AGREEMENT
--------------------------------------------------------
December 31, 2001
Xx. Xxxxxxxxxx Xxxxxxxx
MDH s.r.l. Forniture Ospedaliere
Xxx Xxxxx Xxxxxx, 00
00000 Xxxxx
Xxxxx
Dear Gianfranco:
This letter is the Amended and Restated Agreement ("Agreement") between
MDH s.r.l. Forniture Ospedaliere ("you") and XXXX Medical Systems, Inc. ("XXXX")
under which you are appointed as a distributor in the territory described on
Exhibit A to this Agreement (the "Territory") of the XXXX-branded products
listed on Exhibit B to this Agreement (the "Products"). This Agreement amends
and restates in its entirety the International Distributor Agreement between you
and XXXX dated December 12, 2000 (the "Prior Agreement"). The parties hereto
agree that the Prior Agreement is hereby terminated. This Agreement constitutes
the entire agreement and understanding of the parties with respect to the
subject matter of this Agreement and supersedes all prior discussions,
agreements and understandings. The terms and conditions under which you will act
as RITA's distributor are as follows:
1. PRODUCTS AND TERRITORY
----------------------
You shall act as RITA's distributor in the Territory (described in
Exhibit A) to promote, sell and distribute the Products (described in
Exhibit B) in the approved "Field of Use" and to provide service with
respect to the Products to the Medical Community. The approved Fields
of Use are liver, bone and prostate cancer. RITA's action or failure
to act with respect to this Field of Use restriction shall not in any
way serve to waive or limit its current or future rights with regard
to this provision. As used in this Agreement, "Medical Community"
means medical doctors, institutions such as hospitals and clinics, and
similar institutions that are active in the personal care of patients.
You are not authorized to sell any Products to any of your competitors
or to any of RITA's competitors without RITA's prior written consent.
You shall not actively solicit orders from customers domiciled outside
the Territory, or sell or deliver any Product to any customer that is
not in the Territory. Notwithstanding the foregoing, from time to
time, you may be asked to sell or deliver Products (or you may have
sold or delivered Products) to customers in nations outside the
Territory but within the European Economic Area (EEA). You may only
sell or
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
deliver Products to such customers with RITA's prior written consent
for each order or shipment, which will specify the terms on which such
a sale or delivery are acceptable to XXXX. In no event does any such
sale or delivery or RITA's consent to such a sale or delivery confer
on you any rights to sell or deliver Products or provide services to
such a customer in the future, nor does any such sale or delivery
entitle you to request any future compensation regarding that
customer. Further, in case XXXX does not consent to the sale or
delivery of Products to a customer outside the Territory, as described
above, you shall not have any rights to any indemnification or
compensation for your activities related to that customer.
Furthermore, you shall not appoint any distributor or any agent or
maintain any sales, service or stock facility outside the Territory
with respect to the Products. A breach of the obligations of this
Section 1 shall be considered a failure to fulfill a material
obligation under this Agreement. XXXX reserves the right to promote to
and directly support certain high-profile accounts in the Territory
not currently among your customer base for XXXX products, when
specifically requested to do so by the account. XXXX will make every
reasonable effort to ensure that any resulting orders will be placed
by the customer with MDH.
2. SALES PROMOTION AND REPORTING RESPONSIBILITIES
----------------------------------------------
You shall be obligated to actively promote RITA's products according
to Section 1 above, at your sole expense. This includes, but is not
limited to, the activities described below in this Section. You shall
attend and exhibit at all major trade shows in your Territory related
to the Products. You shall provide training and clinical education to
all of the customers in your Territory. You shall provide appropriate
promotional materials in the language of your Territory, and XXXX
shall have the right to review and approve promotional materials in
advance. You shall be obligated to provide a sales report to XXXX on a
monthly basis, by the 15th of the month following the reporting
period, which details your sales to customers, including the customer
name, quantity and selling price as well as the current inventory
status of all Products which are in your possession at the end of the
month on copies of the form attached as Exhibit F to this Agreement
(or such form as XXXX may provide from time to time). You shall
provide to XXXX, on request, copies of any tenders for the Products in
your Territory. You shall identify and assist XXXX in the development
of a minimum of three (3) faculty/preceptor physicians, co-sponsor
with XXXX a minimum of three (3) workshops and exhibit the XXXX System
on your own stand at a minimum of two (2) relevant national
conferences for each Field of Use. You shall prepare an itinerary and
support joint sales calls by the Director of European Sales together
with your sales agents and Area Managers to key accounts and other
customers as requested by XXXX, at a minimum once per quarter. Prior
to the commencement of each succeeding one year period under this
contract ("Succeeding Year"), you shall provide to XXXX a business
plan that describes your results for the prior year and your plans for
the coming year.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
XXXX shall be obligated to provide you with such technical support as
may be deemed necessary by XXXX to provide you with a full
understanding of the Products. XXXX shall also provide you with a
reasonable number of its then existing catalogs, brochures and other
promotional materials in the English language to facilitate your
promotion of the Products.
Failure to provide monthly sales/inventory reports, annual business
plan and copies of any tenders for the Products in your Territory
shall be considered failures to fulfill material obligations of this
Agreement.
3. ORDERS AND MINIMUM PURCHASE QUANTITIES
--------------------------------------
All purchase orders shall be governed by the terms of this Agreement
and RITA's standard acknowledgement form, provided that if any
conflicts shall occur, this Agreement shall prevail.
For the purpose of securing orderly shipments, you shall submit to
XXXX a rolling four (4) calendar quarter forecast of orders for the
Products at the beginning of each calendar quarter. The first rolling
forecast is due within thirty (30) days of the signing of this
Agreement. The first two (2) quarters of the rolling forecast shall be
binding. Obligations to purchase or supply product shall be binding
only while this Agreement remains in effect.
In the first year of this Agreement, you shall purchase the minimum
quantity of Products in each of the four (4) quarters set forth on
Exhibit C. In Succeeding Years, the minimum quantity of Products to be
purchased shall be as agreed between the parties in writing at least
thirty (30) days prior to the start of each Succeeding Year.
If additional products are added by XXXX to the Products listed in
Exhibit B, then the minimum quantity of Products to be purchased shall
be as agreed between the parties in writing at least sixty (60) days
in advance of the Product addition.
Failure to purchase the minimum quantity of products in each calendar
quarter and/or failure to provide a rolling four (4) calendar quarter
forecast of orders for the Products at the beginning of each calendar
quarter shall be considered failures to fulfill material obligations
of this Agreement.
4. RETURNS
-------
Products may only be returned with the prior written approval of XXXX.
Any such approval shall reference a return material authorization
number issued by XXXX. Repair and transportation costs for returned
Products not under warranty shall be borne by you. Repair and
transportation costs for returned Products under warranty shall be
borne by XXXX, provided, if XXXX determines that the returned Products
were not defective, such costs shall be borne by you.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
5. PRICES
------
In the first year of this Agreement, you shall pay for Products the
prices ("Prices") listed on Exhibit D hereto. Beginning with the
second year of this Agreement, Seller may make unilateral adjustments
to Product prices with sixty (60) days prior written notice.
If additional products are added by XXXX to the Products listed in
Exhibit B, then the Prices shall also be as agreed between the parties
in writing at least sixty (60) days in advance of the Product
addition.
6. PAYMENT
-------
Full payment of your purchase Price for the Products (including any
freight, taxes or other applicable costs initially paid by XXXX but to
be borne by you) shall be in United States of America dollars. All
exchange, interest, banking, collection, and other charges shall be at
your expense. Payment terms shall be irrevocable letter of credit,
confirmed on a U.S. bank, payable at 90 days sight. Determination of
payment terms will depend upon the status of your payment history and
outstanding receivables balance. Any invoiced amount not paid when due
shall be subject to a service charge at the lower of the rate of one
and one-half percent (1.5%) per month or the maximum rate permitted by
law. If you fail to make any payment to XXXX when due, XXXX may,
without affecting its rights under this Agreement, cancel or delay any
future shipments of the Products to you. Further, such a failure to
pay shall be considered a failure to fulfill a material obligation
under this Agreement.
7. COMPLAINTS
----------
If you receive any written, electronic or oral communication that
alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness or performance of the Products, you
shall promptly report them to XXXX on copies of the form attached as
Exhibit E to this Agreement (or on such form as XXXX may provide from
time to time) and you shall provide all necessary assistance in
connection with any corrective action with respect to the Products.
Any determination of corrective action shall be made by XXXX in its
sole discretion.
8. COMPLIANCE WITH TERRITORIAL REGULATIONS
---------------------------------------
You shall comply with and advise XXXX of all applicable laws, rules
and regulations of the Territory governing the use, sale,
distribution, shipment and import of the Products. With respect to
those Products that have not yet received approval for commercial
sale, you shall also comply with the laws, rules and regulations of
the Territory concerning use, sale,
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
distribution, shipment and import of unapproved products, and with any
applicable XXXX clinical trial protocol. In connection with these
obligations regarding products that are approved or have not yet
received approval, you shall obtain and keep in effect all required
licenses, permits and authorizations (collectively,
"Registration(s)"), provided however, that the CE approval shall be
obtained and kept in effect by XXXX.
Except for CE approval, you shall pay all applicable Registration
fees, duties, taxes and other expenses relating to the sale and use of
the Products within the Territory. XXXX shall provide you with all
necessary assistance in connection with your obtaining Registrations
which XXXX concurs in writing are necessary for the conduct of your
business. You will advise XXXX, upon RITA's request, of the status of
all Registrations, and you will notify and provide XXXX documentation
whenever any change of Registration status occurs and whenever any
Registration is called into question. All such Registrations shall be
in the name of XXXX or, if Registration in RITA's name is prohibited
by applicable law, in the name of a party designated in writing by
XXXX or in trust for XXXX. XXXX shall have the sole authority to
cancel or transfer (or direct the cancellation or transfer of) all
such Registrations. If this Agreement is terminated for any reason,
you shall transfer all Registrations held by you in connection with
your distribution of the Products to XXXX or its designee.
To the extent that the law requires XXXX, rather than you, to file any
Registration, XXXX shall register the Products as required by law. You
shall provide all necessary assistance in connection with the filing
of such Registrations.
All activities with respect to tenders shall be conducted so as to
allow, upon termination of this Agreement for any reason, and upon
RITA's written request, transfer of such tenders to XXXX or to such
party as XXXX designates in writing.
XXXX may provide you with information concerning the manufacture of
the Products to increase your ability to obtain Registrations. You
agree that such information will be disclosed only to those of your
employees who are authorized by XXXX in writing to receive such
information.
9. COMPLIANCE WITH U.S. REGULATIONS
--------------------------------
XXXX shall be responsible for compliance with all applicable United
States laws and regulations governing the manufacture and sale of the
Products. You shall comply, and use your best efforts to assist XXXX
in complying, with all applicable United States laws and regulations
including the maintenance of all required books, records and reports.
In particular, you shall track the serial numbers and lot numbers of
Products delivered to your customers. This obligation shall survive
the termination of this Agreement for a period no less than the life
of any distributed Products.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Audits of such records and the distribution storage area may be
audited at any time by XXXX personnel to assure compliance.
10. RECALLS
-------
You shall cooperate with XXXX in effecting any recall of the Products
which, in RITA's opinion, is necessary. Recalls may only be authorized
in writing by XXXX. This obligation shall survive the termination of
this Agreement for a period no less than the life of any distributed
Products.
11. PROPRIETARY PROPERTY OF XXXX
----------------------------
You expressly acknowledge that you do not have and shall not acquire
under this Agreement any rights in or to any of RITA's patents,
trademarks or trade names or to any patents, trademarks or trade names
of any subsidiary or other affiliate of XXXX. You further acknowledge
that you shall use not at any time use, register, or obtain in your
own or any other name, RITA's corporate name, or any of its other
trademarks or trade names without RITA's prior consent in writing. You
further acknowledge that you do not have and shall not acquire under
this Agreement rights to any of RITA's know-how regarding the design
or manufacture of the Products.
You, your principals and consultants agree at all times during the
term of this Agreement and thereafter, to hold in strictest
confidence, and not use, except for the benefit of XXXX, or disclose
to any person, firm, corporation or any other entity without written
authorization by XXXX, any Confidential Information of XXXX which you
obtain or create. You further agree not to make copies of such
Confidential Information except as authorized by XXXX. You understand
that "Confidential Information" means any XXXX proprietary
information, technical data, trade secrets or know-how, including, but
not limited to research, product plans, products, services, suppliers,
customer lists and customers (including, but not limited to, customers
of XXXX on whom you called or with whom you became acquainted during
the term of the Agreement), prices and costs, markets, software,
developments, inventions, laboratory notebooks, processes, formulas,
technology, designs, drawings, engineering, hardware configuration
information, marketing, licenses, finances, budgets or other business
information disclosed to you by XXXX orally, in writing or by
drawings.
Except with the prior written consent of XXXX, during the term of this
Agreement and for a period of one (1) year following termination of
the Agreement you, your principals and consultants shall not sell or
advertise within the Territory, either on your own behalf or on behalf
of any other person, company, or corporation, products which compete,
directly or indirectly, with the Products.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
12. WARRANTY
--------
XXXX extends to you, only, in respect of each new and unused Product
supplied to you, a warranty on terms identical to that contained in
the warranty certificate enclosed and delivered with such Product when
sold directly by XXXX. RITA's liability is limited in all respects by
the terms and conditions of such warranty.
XXXX agrees that such warranty will have a term of twelve (12) months
from the date of its sale to you for Products with no expiration date
and a term extending until the expiration date for Products which have
such an expiration date, providing such Products are unopened and
undamaged.
ALL OTHER GUARANTEES, WARRANTIES, CONDITIONS AND REPRESENTATIONS,
EITHER EXPRESS OR IMPLIED, WHETHER ARISING UNDER ANY STATUTE, COMMON
LAW, CASE LAW, COMMERCIAL USAGE, CUSTOM OR OTHERWISE, INCLUDING
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE, ARE HEREBY EXCLUDED.
13. LIABILITY ACTIONS
-----------------
You shall give XXXX immediate written notice if you become aware of
any legal action deriving from the use of the Products by customers
and include in such notice all facts relating to the legal action of
which you are aware. XXXX shall indemnify you during the term of this
Agreement to the extent that it and you are covered by its commercial
general liability policy (including products liability) then in effect
for any such claims which are brought against you, except for claims
which arise from your negligence, action or failure to act. XXXX shall
have the right, but not the obligation, to defend any such claim
during or after the term of this Agreement and to settle it on such
terms as XXXX xxxxx appropriate. You shall cooperate fully with XXXX
in connection with such defense.
14. DURATION AND TERMINATION
------------------------
This Agreement shall be for a minimum of a one (1) year period
commencing on January 1, 2002 (the "First Year"). This Agreement shall
automatically renew for successive one (1) year periods unless notice
is given by either party in writing ninety (90) days prior to the
renewal date. This Agreement may be terminated as noted below:
(1) by XXXX, upon thirty (30) days written notice if you do not
purchase the minimum quantity of Products in any given quarter,
as per Section 3 above.
(2) by XXXX, immediately upon written notice if you, your principals
or consultants sell or advertise within the Territory, either on
your own behalf or on behalf of
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
any other person, company, or corporation, products which
compete, directly or indirectly, with the Products.
(3) by either party upon thirty (30) days written notice to the other
if the parties fail to reach agreement as to minimum purchase
quantities (according to Section above) either (a) prior to the
commencement of any one (1) year renewal period or (b) following
written notification by XXXX of an addition to the Products; or
as to prices (according to Section 5 above) following written
notification by XXXX of a price increase or an addition to the
Products.
(4) by either party for any reason or no reason, after the First
Year, upon ninety (90) days written notice to the other.
(5) by either party immediately upon written notice to the other if
the other party fails to fulfill its material obligations
hereunder and such failure is not cured within thirty (30) days
after its receipt of written notice requesting a remedy thereof.
A choice by either party not to terminate this Agreement due to
the other party's failure to perform a material obligation under
this Agreement shall not relieve either party of any of its
material obligations hereunder, and any future or continuing
failure to perform the material obligations of this Agreement
shall be grounds for termination of this Agreement.
(6) by either party upon written notice if the other party becomes
insolvent or any voluntary or involuntary petition in bankruptcy
is filed by or against such party or a trustee is appointed with
respect to any of the assets of such party or a liquidation
proceeding is commenced by or against such party and such
proceeding has not been terminated within ninety (90) days, or if
such party discontinues its business.
In the case of termination of this Agreement by either party for any
reason, XXXX shall have the right, but not the obligation, to purchase
from you undamaged, saleable inventory at the original invoice price
to you.
Only the following Sections of this Agreement shall survive its
termination: 4, 6, 8, 9, 10, 11, 12, 13, 14 and 16.
Other than the specific provisions in this Section, neither party
shall have any remedy upon termination due to such termination,
provided that this shall have no effect on the surviving Sections of
this Agreement, which remain in effect and enforceable allowing any
remedy specifically associated with them.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
15. FORCE MAJEURE
-------------
Neither party shall be responsible to the other party for
non-performance or delay in performance under this Agreement due to
acts of God, civil commotion, war, riots, strikes, lockouts, severe
weather, fires, explosions, governmental actions or other similar
causes beyond the control of such party, provided that the party so
affected shall promptly give notice thereof to the other party and
shall continue to take all action reasonably within its power to
comply herewith as fully as possible. In any event, the time for
performance hereunder shall only be extended for the duration of the
delay.
16. GENERAL PROVISIONS
------------------
The validity, interpretation, construction and performance of this
Agreement shall be governed by the laws of the State of California,
without giving effect to the principles of conflict of laws. Any
dispute or claim arising out of or in connection with any provision of
this Agreement will be finally settled by binding arbitration in Santa
Xxxxx County, California in accordance with the rules of the American
Arbitration Association by one arbitrator appointed in accordance with
said rules. The arbitrator shall apply California law, without
reference to rules of conflicts of law or rules of statutory
arbitration, to the resolution of any dispute. Judgment on the award
rendered by the arbitrator may be entered in any court having
jurisdiction thereof. Notwithstanding the foregoing, the parties may
apply to any court of competent jurisdiction for preliminary or
interim equitable relief, or to compel arbitration in accordance with
this paragraph, without breach of this arbitration provision.
Any notice required or permitted by this Agreement shall be in writing
and shall be deemed sufficient upon receipt, when delivered personally
or by courier, overnight delivery service or confirmed facsimile, or
forty-eight (48) hours after being deposited in the regular mail as
certified or registered mail (airmail if sent internationally) with
postage prepaid, if such notice is addressed to the party to be
notified at such party's address or facsimile number as set forth
below, or as subsequently modified by written notice.
XXXX Medical Systems, Inc.
000 X. Xxxxxxxxx Xxxxxxxxx
Xxxxxxxx Xxxx, XX 00000 XXX
Attn: Xxxxx Xxxxxxx
Fax: 000-000-0000
MDH s.r.l. Forniture Ospedaliere
Xxx Xxxxx Xxxxxx, 00
00000 Xxxxx, Xxxxx
Attn: Xxxxxxxxxx Xxxxxxxx
Fax: 00-00-000 16535
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
The provisions of this Agreement shall be deemed to be severable, and
the invalidity of any provision of this Agreement shall not affect the
validity of the remaining provisions of this Agreement.
No amendment or modification of this Agreement shall be binding on the
parties unless made in writing expressly referring to this Agreement
and signed by authorized representatives of each party.
This Agreement is not assignable by either party in whole or in part
without the prior written consent of the other party, and any
attempted assignment without such approval shall be null and void,
except that consent shall not be required in the case of a transaction
involving the merger, consolidation or sale of substantially all of
the assets of XXXX.
By your signature below, you acknowledge and agree to all of the foregoing terms
and conditions. Until so executed by you and XXXX and returned to XXXX, this
Agreement shall not be binding on either party, and unless executed by you and
returned to XXXX within ten (10) days of the date set forth on the first page
hereof, this Agreement shall expire without further notice and shall be null and
void.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
The parties executed this Agreement on the respective dates set forth
below.
XXXX MEDICAL SYSTEMS, INC.
By: /s/ Xxxxxx Xxxxxxx
------------------
Title: Chief Financial Officer
-----------------------
Address: 000 X. Xxxxxxxxx Xxxx.
Xxxxxxxx Xxxx, XX 00000
Date: 1/2/02
------
MDH S.R.L. FORNITURE OSPEDALIERE
By: /s/ Xxxxxxxxxx Xxxxxxxx
-----------------------
Title: Scientific & General Manager
----------------------------
Address: Xxx Xxxxx Xxxxxx, 00
00000 Xxxxx, Xxxxx
Date: 1/7/02
------
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Exhibit A
Territory
Italy
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Exhibit B
Products
GENERATORS
Model Number Part Number
------------ -----------
Model 1500 700-101623
ELECTRODES
Model Number Part Number Description
------------ ----------- -----------
StarBurst 700-101492 7 array, 2-3 cm, 15 cm
StarBurst 700-101493 7 array, 2-3 cm, 25 cm
StarBurst XL 700-101320 9 array, 3-5 cm, 15 cm
StarBurst XL 700-101317 9 array, 3-5 cm, 25 cm
ACCESSORIES
Model Number Part Number
------------ -----------
Main Cable 700-101339
Foot Switch 400-100453
Dispersive Electrode 700-101441
Power Cord (Italy) 400-100698
Software 700-101689
Passive Temperature Probe, Urology, 2 key 700-100986
At its sole discretion: (1) XXXX may discontinue any product on this
list and (2) XXXX may add additional products to this list, or (3) may
substitute equivalent products.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Exhibit C
Minimum Purchase Target
Product First Contract Year
------- --------------------------------
Calendar Quarter
2002 Liver
--------------------------------
Q1 Q2 Q3 Q4
Model 1500 Generator* [***] [***] [***] [***]
StarBurst** [***] [***] [***] [***]
StarBurst XL** [***] [***] [***] [***]
2002 Bone & Urology
--------------------------------
Q1 Q2 Q3 Q4
Model 1500 Generator* [***] [***] [***] [***]
StarBurst** [***] [***] [***] [***]
Passive Probes, Urology [***] [***] [***] [***]
* Each Generator is supplied with one (1) Power Cord, one (1) Main Cable and
one (1) Foot Switch, as well as, upon request, one (1) XXXX-Base Data
Collection Software.
** Each Model 70, StarBurst and Starburst XL Electrode is supplied with two
(2) Dispersive Electrodes.
NOTE: In the case of any additions to the Products listed in Exhibit B, the
purchase of any new model generators or any new model electrodes shall be
credited against the minimum purchase targets detailed above.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Exhibit D
Pricing Schedule
Distributor Price
Product First Year of Agreement
------- -----------------------
Model 1500 Generator* $ [***]
StarBurst Electrodes ** $ [***]
StarBurst XL Electrodes** $ [***]
Passive Probe, Urology $ [***]
Main Cable $ [***]
Foot Switch $ [***]
Dispersive Electrode $ [***]
Power Cord (Italy) $ [***]
XXXX-Base Data Collection Software $ [***]
No discounts for sub-agents
* Each Generator is supplied with one (1) Power Cord, one (1) Main Cable and
one (1) Foot Switch, as well as, upon request, one (1) XXXX-Base Data
Collection Software.
** Each StarBurst and Starburst XL Electrode is supplied with two (2)
Dispersive Electrodes.
NOTE: All part numbers are per Exhibit B and terms are Ex-works RITA's
manufacturing location.
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Exhibit E
Complaint Form
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
DISTRIBUTOR COMPLAINT REPORT FORM
--------------------------------------------------------------------------------
To Be Completed By Distributor:
1. Date Received: Received By:
--------------------- ------------------------
2. Product Description:
-----------------------------------------------------
Lot Number: Model Number:
----------------------- ------------------------
3. Complainant*:
------------------------------------------------------------
*Complainant is the person to whom the response letter will be written.
Address:
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City, State, Zip Code:
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Telephone: Fax:
-------------------------- ------------------------------
4. Site Of Event:
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Site Address:
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City, State, Zip Code:
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5. Device Returned: [ ] Yes [ ] No
Date Shipped RMA Number
---------------- ---------------
6. Treatment Date: Indication:
-------------------- --------------------------
Treatment Site:
----------------------------------------------------------
Patient Status: [ ] Procedure Completed Without Incident
[ ] Other
--------------------------------------------
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7. Description of Event:
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------------------------------------------------------[ ] See Attached
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*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Exhibit F
Monthly Sales Report Form
*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
Monthly Sales Report Form
Distributor:
---------------------------------------
Territory:
---------------------------------------
Month:
---------------------------------------
Current Month Information:
===================== ======================================= ================
Unit Sales (Part No.) Product Quantity
===================== ======================================= ================
700-101505 RF Generator Model 1500
--------------------- --------------------------------------- ----------------
700-101492 XxxxXxxxx, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-101493 XxxxXxxxx, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-101320 StarBurst XX, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-101417 StarBurst XX, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-100986 Passive Probe, Urology
-------------------------------------------------------------- ----------------
===================== ======================================= ================
Remaining Inventory Product Quantity
(Part No.)
===================== ======================================= ================
700-101505 RF Generator Model 1500
--------------------- --------------------------------------- ----------------
700-101492 XxxxXxxxx, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-101493 XxxxXxxxx, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-101320 StarBurst XX, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-101417 StarBurst XX, 0 Xxxxx, 0-0 xx, 00 cm
--------------------- --------------------------------------- ----------------
700-100986 Passive Probe, Urology
-------------------------------------------------------------- ----------------
Core Account Update: (Only List Accounts That: a) own generators or b) have a
long-term arrangement that is equivalent to owning. Do not include
hospitals/accounts that have generators for evaluation.) Please add more lines
as necessary so that all "Core" accounts are listed.
=========================================== ===================================
Existing Customer # Electrodes Sold:
=========================================== ===================================
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*** Material has been omitted pursuant to a request for confidential treatment,
and such material has been filed separately with the SEC.
