Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
AMENDMENT
TO
INTERNATIONAL DISTRIBUTION AGREEMENT
This Amendment to International Distribution Agreement is made as of the
26th day of February, 1999, between Urologix, Inc., a corporation organized and
existing under the laws of the State of Minnesota ("Urologix") and Boston
Scientific Corporation, a corporation organized and existing under the laws of
Delaware ("BSC").
BACKGROUND
By an agreement dated June 26, 1996 (the "Agreement"), Urologix granted BSC
the rights and responsibilities of an exclusive distributor of the Products of
Urologix in all areas of the world except the United States and Japan.
Urologix and BSC now desire that Urologix aid BSC in developing the market
for the Products in Europe and certain other areas of the world for a particular
period of time.
The parties desire that through its efforts, Urologix will solicit the sale
of certain Products previously purchased by BSC (the "Beek Products"). BSC will
pay Urologix a certain amount to enable Urologix to pay all or a portion of its
expenses in conjunction with this effort, and the revenues derived from the
customers who purchase these Products will, in most situations, be received and
retained by BSC.
[CONFIDENTIAL TREATMENT REQUESTED]
TERMS AND CONDITIONS
NOW THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. Market Development Amount. BSC will pay an amount ("the Market
Development Amount") to Urologix to enable Urologix to perform market
development activities for the Products primarily in Europe, Eastern Europe, and
the Middle East, and, upon consultation with BSC, in certain other areas of the
world offering significant near-term market potential as determined by Urologix
in its reasonable business judgment. The Market Development Amount for the
period from January 1, 1999 through December 31, 1999 (the "First Amendment
Period") shall be equal to U.S. [Confidential Treatment Requested]. The Market
Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Development Amount for the period from January 1, 2000 through June 30, 2001
(the "Second Amendment Period"), if any, will be as mutually agreed upon by
Urologix and BSC. In addition, BSC will pay Urologix [Confidential Treatment
Requested] upon execution of the Amendment as the Market Development Amount for
Urologix's market development services from October 1, 1998 through December 31,
1998 (the "Prior Period"). The Market Development Amounts shall be used only for
marketing activities contemplated by Urologix' current budget for the
expenditure of the Market Development Amount for the First Amendment Period as
set forth in Exhibit II (the "Plan"), which Plan may be modified by Urologix
after consultation with BSC in accordance with Section 8 hereof from time to
time in its reasonable business judgment.
1.1. The Market Development Amount for the First Amendment Period will
be paid in quarterly installments on the dates and in the amounts set forth
on Exhibit III by wire transfer to the account designated by Urologix for
that purpose; provided that in the event that (i) Urologix fails to achieve
any periodic milestone set forth in Section 6 hereof by the end of the
quarter for which such milestone is required to be achieved, and (ii)
Urologix does not achieve the quarterly sales revenue target for sales of
Beek Products set forth in Exhibit IV for such quarter, BSC may, by written
notice given to Urologix within thirty (30) days after the end of such
quarter, elect to terminate this Amendment and the Agreement.
1.2. Beginning with the First Amendment Period, Urologix will not be
expected or obligated to fund any of these market development activities
not covered by the Market Development Amount from its own resources but may
do so if it so chooses.
1.3. If the sales of Beek Products solicited by Urologix generate more
than [Confidential Treatment Requested] in net revenue for BSC during the
First Amendment Period or during the Second Amendment Period (or both), and
Urologix achieves the minimum [Confidential Treatment Requested] aggregate
gross margin target referred to in Section 4.1 during that period, BSC will
pay Urologix, as an additional Market Development Amount, an amount equal
to [Confidential Treatment Requested] of the amount by which the net
revenues for such period exceed [Confidential Treatment Requested]. Such
additional Market Development Amount, if any, will be paid by BSC within
thirty (30) days after the end of the period to which it relates and shall
be used for market development purposes.
2. Marketing. Urologix will use reasonable commercial efforts within the
constraints of the Market Development Amount received from BSC to solicit the
sale of Beek Products during the term of this Amendment. Urologix will not,
during the term of this Amendment, make any sales of Products in the Territory
other than sales of Beek Products, unless BSC does not
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
have sufficient quantities after request therefor to BSC available to timely
ship the Product involved to customers solicited by Urologix. Set forth on
Exhibit I is a description of (i) all Control Units and Procedure Kits which BSC
currently holds in inventory at its warehouse in Beek, Netherlands, and
[Confidential Treatment Requested] together with its location and current book
value.
3. Term of Amendment. This Amendment will be effective from October 1,
1998, through December 31, 1999. During the First Amendment Period, the parties
will discuss their satisfaction with this arrangement and determine whether they
mutually wish to extend the term of this Amendment for a portion or all of the
Second Amendment Period , and if so, the terms of that extension. Neither party
will be obligated to extend the term of this Amendment to include a portion or
all of the Second Amendment Period unless all of the terms of any such extension
are acceptable to that party in its sole discretion. If the term of this
Amendment is not extended after December 31, 1999, the rights and obligations of
BSC and Urologix thereafter under this Amendment and the Agreement will be as
set forth in Section 13.
4. Procedure. The Beek Products sold by Urologix during the term of this
Amendment will be sold in accordance with following procedures:
4.1. Price. Urologix will determine the price at which the Beek
Products are sold. BSC will provide Urologix monthly with the actual book
value of all Control Units and Procedure Kits. Except with respect to the
sale of Products described in Section 4.5 hereof, Urologix will seek an
average gross margin of not less than [Confidential Treatment Requested],
in the aggregate, with respect to all Beek Products sold by Urologix during
the First Amendment Period. There are no assurances that Urologix will
achieve such a gross margin, and Urologix will not be penalized in any
manner if it does not achieve such a gross margin. For this purpose, gross
margin is defined as the difference between the actual sales price of the
Control Unit sold less (a) in the case of Control Units in the field as
demonstration, clinical, or seeding units, BSC's transfer price from
Urologix or (b) in the case of Control Units held by BSC in inventory,
BSC's transfer price from Urologix, unless otherwise agreed by BSC and
Urologix, for each such unit. BSC shall receive and retain the entire price
at which the Beek Products are sold.
4.2. Regular Purchase Orders. Urologix will inform BSC of all purchase
orders received with respect to Products within three business days of
receipt thereof. Within three days after being so informed by Urologix, BSC
may accept any such purchase order in accordance with its terms. If BSC so
accepts such a purchase order, BSC will be responsible for the proper and
timely shipment of the Products involved to, and the invoicing of, that
customer and for the collection of all amounts due BSC from any such
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
sale.
4.3. Special Purchase Orders. If BSC does not accept any purchase
order in accordance with the procedure described in Section 4.2, BSC will
be deemed to have allowed Urologix the opportunity, at its option, to
itself complete that sale under an arrangement whereby Urologix will: (i)
take possession and title of those Products F.O.B. Beek and pay all
shipping costs for the Products involved; (ii) [Confidential Treatment
Requested]; and (iii) be responsible for the collection of all amounts due
from the customer under that purchase order and retain for itself all
amounts so collected. If Urologix elects to so proceed with the transaction
involved, BSC will promptly ship the Products involved to that customer on
behalf of Urologix in accordance with Urologix= instructions and warrant to
Urologix that the Product functions in accordance with original Product
specifications at the time of installation if properly installed. All
amounts paid by Urologix to BSC under this Section 4.3 will be considered
revenue to BSC for purposes of Sections 1.1 and 1.3.
4.4. Demonstration Units; Clinical Units; Seeding Units. BSC has
placed [Confidential Treatment Requested] Control Units for demonstration,
clinical, seeding, and other non-revenue purposes. Urologix may not place
any additional Control Units from the Beek Products for any such purposes
without the written consent of BSC. Urologix may solicit the sale of up to
[Confidential Treatment Requested] of these [Confidential Treatment
Requested] Control Units as used equipment at special prices if it has an
opportunity to do so, subject to Section 4.1 hereof.
4.5. Demonstration Catheters. Urologix may provide Procedure Kits from
the Beek Products to third parties without charge. Any such Procedure Kits
will be deemed to have been sold by Urologix for [Confidential Treatment
Requested], which amounts shall be remitted by Urologix to BSC in
accordance with the terms hereof. Such deemed sales of Procedure Kits shall
not be included in the calculation of aggregate gross margin set forth in
Section 4.1 hereof.
4.6. Congresses and Trade Shows. Urologix may display the Products at
congresses and trade shows in Europe and certain other areas of the world.
If Urologix prefers to display the Products at a BSC booth at any of those
congresses or trade shows, Urologix may do so on terms to be coordinated
between Urologix and BSC with reasonable lead time and planning.
4.7. Personnel. Urologix will offer a market development position for
the German speaking countries to an employee of BSC who was involved in the
sale of the
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Products in Europe on behalf of BSC.
4.8. Inventory. BSC may purchase from Urologix from time to time, such
additional units of any of the Products as may be necessary to enable BSC
to fill orders for the sale of the Products on a timely basis. BSC shall
pay Urologix [Confidential Treatment Requested] for each such Procedure Kit
and [Confidential Treatment Requested] for each such Control Unit, unless
otherwise agreed by BSC and Urologix.
5. Reports. Each party will provide the other party with the reports
described below:
5.1. By Urologix to BSC. By the 25th day of each calendar quarter,
Urologix will provide to BSC (a) a quarterly report which describes the
aggregate amount of all expenses paid from the Market Development Amount
during the preceding quarter, and year to date, in each of the expense
categories described on Exhibit V and (b) a quarterly report of all sales
and placements of Beek Products during the preceding calendar quarter and
related transfer prices.
5.2. By BSC to Urologix. By the 25th day of each calendar quarter, BSC
will provide a quarterly report which contains the following information
for the preceding quarter and year to date: BSC's inventory of Control
Units and of Procedure Kits, the book value of the Control Units which
remain in the field as demonstration, clinical or seeding units, BSC's
gross revenue from the sale of Control Units and from the sale of Procedure
Kits under this Amendment, BSC's average gross margin with respect to the
sale of Control Units under this Amendment and the number of Control Units
installed by BSC.
6. Other Efforts: Within the constraints of the Market Development Amount
and Urologix= reasonable commercial efforts as to the appropriate priorities
with respect to the use of the Market Development Amount to develop the market
for the Products in Europe all as reflected in the Plan, Urologix will endeavor
to achieve the following:
6.1. Clinical Research Activities: Initiate and conduct clinical
studies, after consultation with BSC in accordance with Section 8, with
respect to Products in the following countries in accordance with the
following timetables:
[Confidential Treatment Requested]
5
6.2. Training and Education:
(a) [Confidential Treatment Requested]
(b) [Confidential Treatment Requested]
6.3. Key Opinion Leaders:
(a) [Confidential Treatment Requested]
(b) [Confidential Treatment Requested]
7. Independent Distribution Agreements. Even though BSC currently has
exclusive distribution rights in the Territory, Urologix may enter into
distributor agreements directly between Urologix and the distributor involved in
any country in the Territory as part of its market development activities under
this Amendment. Urologix expenses in establishing these relationships will be
paid from the Market Development Amount. Those agreements may be for terms which
exceed the term of this Amendment or the Agreement, provided such agreements do
not have terms in excess of twelve (12) months or are terminable on six (6)
months notice.
7.1. New Distributors. When Urologix has entered into such a
distributor agreement, it will so advise BSC in writing. Within five
business days after BSC receives that notice, BSC will advise Urologix as
to whether it wishes to deal with any such distributor (a "New
Distributor") as a Regular Distributor or Special Distributor, as both of
those relationships are defined below. If BSC does not so notify Urologix
within that period, any such New Distributor will be deemed to be a Special
Distributor.
7.2. Regular Distributors. If BSC designates the New Distributor as a
Regular Distributor, then BSC will accept all purchase orders received from
that New Distributor in accordance with their terms; will be responsible
for the proper and timely shipment of all Products to that New Distributor,
and will be responsible for all invoicing and collection with respect to
all purchase orders from that New Distributor.
7.3. Special Distributors. If BSC designates, or is deemed to have
designated, a New Distributor as a Special Distributor, then BSC will sell
to Urologix, on the following terms, all Products which Urologix desires to
resell to the Special Distributor: (i) Urologix will take possession of
those Products F.O.B. Beek and pay all shipping costs for the Products
involved; (ii) Urologix will
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
pay BSC, within 90 days of shipment [Confidential Treatment Requested],
unless otherwise agreed by BSC and Urologix; (iii) Urologix will be
responsible for the collection of all amounts from the Special Distributor
and will retain for itself all amounts so collected; and (iv) BSC will
promptly ship the Products involved to Special Distributors on behalf of
Urologix in accordance with Urologix instructions and warrant to Urologix
that the Product functions in accordance with original Product
specifications at the time of installation if properly installed. All
amounts paid by Urologix to BSC under this Section 7.3 will be considered
revenue to BSC for purposes of Section 1.1 and Section 1.3.
8. Reporting Relationship. Rob ten Hoedt of Urologix will report quarterly
on the progress of the market development effort to Xxxx XxXxxxxxxx and Xxxxxxx
Xxxxxxx of BSC, and will have regular contact on an operational matters with
Xxxx Xxxx of BSC in Natick. The foregoing persons or their representatives will
attend quarterly management meetings to review the progress of the arrangements
contemplated by the Amendment and to discuss potential revisions to the Plan,
Market Development Amounts and performance targets, which are mutually
acceptable.
9. Service. Urologix shall be responsible for service of all existing and
future Control Unit placements. No funding for this activity will be provided by
BSC, although a portion of the Market Development Amount may be used for this
purpose in accordance with the Plan. BSC will make available, at its expense,
one qualified technician who will be responsible for fully servicing two (2)
European treatment sites reasonably designated by Urologix.
10. Regulatory Matters; Labeling; and Product Materials. BSC will remain
responsible for the following responsibilities under Sections 9 and 18 of the
Agreement during the term of the Agreement. Specifically, after consultation
with Urologix in accordance with Section 8 hereof, BSC will use commercially
reasonably efforts to: (i) maintain all existing regulatory agency approvals
which (A) are maintained by BSC as of the effective date of the Amendment as set
forth on Exhibit VI hereto, including regulatory approvals in such countries for
improvements to existing Products and (B) are required for the marketing and
sale of the Products in Europe and those portions of the world where Urologix
establishes distributors; (ii) update as required the labeling and manual
requirements for each of those countries with respect to which it has provided
Urologix information pursuant to Section 9.11 of the Agreement and provide
Urologix with that updated information, with appropriate translations; and (iii)
provide Urologix with translations of all updated promotional and technical
written support materials produced by BSC.
11. Suspension of Agreement Terms. During the period of time this Amendment
is in effect, the applicability of the following portions of the Agreement will
be terminated and of no force or effect with respect to the rights and
obligations of the parties : 4.1, 4.3, 6.1 through 6.6, 7, 9.1, 9.2, 9.3, 9.4
(except for the last sentence thereof), 9.5, 9.9, 10, 11.2 through 11.5, 18.3,
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
and 19. In the event of any conflict between the terms of the Amendment and the
Agreement as amended by the Amendment, the provisions of the Amendment shall
govern. In addition, Urologix shall indemnify BSC in a parallel fashion to BSC's
indemnification obligations under Section 14.1 of the Agreement.
12. Breach. In the event of a breach of the Agreement or this Amendment by
either party which is not cured within sixty (60) days after written notice of
that breach is given by the other party, the non-breaching party may, at any
time thereafter, terminate both the Agreement and this Amendment upon written
notice given to the breaching party.
13. Termination. Upon the expiration or termination of this Amendment or
the Agreement for any reason, both this Amendment and the Agreement will
terminate and, except as provided in this Section 13, neither party will have
any further rights or obligations to the other party under either this Amendment
or the Agreement, and neither BSC nor Urologix will be liable to the other party
for any direct, indirect, collateral, incidental or consequential losses, or
other damages, incurred by the other party arising, directly or indirectly, from
a breach of this Amendment or the Agreement or the termination of this Amendment
and the Agreement. In addition, BSC shall then have the right (i) to cancel any
purchase orders issued by BSC for Products after January 1, 1999, without
penalty, but only with respect to any Products which have not been shipped by
Urologix under those purchase orders, and (ii) to return for refund any Products
which are delivered to BSC either within 30 days before or 30 days after the
receipt by either party of any notice of termination from the other party.
Except as provided by the immediately preceding sentence, BSC must pay Urologix
for all Products delivered by Urologix to BSC pursuant to purchase orders
accepted by Urologix prior to the expiration or termination of this Amendment.
BSC shall have the right to sell to customers in the Territory, or otherwise
transfer to customers in the Territory, any Products in its possession at the
expiration or termination of the Agreement.
14. Waiver and Release. Urologix and BSC each hereby waive and release the
other party from any liability of whatsoever nature arising from any breach by
the other party under the Agreement occurring prior to the effective date of
this Amendment.
15. Entire Agreement. This Amendment is the entire agreement between the
parties with respect to this Amendment. It supersedes all previous oral and
written arrangements between the parties with respect thereto and is intended as
a complete and exclusive statement of the terms of their understanding with
respect to this Amendment.
16. Survival. The provisions of Sections 13 and 14 of this Amendment and
all of the sections cited under Section 30 (Survival) of the Agreement, except
for Sections 11.2 through
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
11.6, shall survive the termination of this Amendment and the Agreement and
continue thereafter in full force and effect.
17. Effect of Amendment. Except as modified by this Amendment, the
Agreement remains in full force and effect.
18. Definitions. Capitalized terms in this Amendment have the same meanings
as under the Agreement, unless separately defined in this Amendment.
IN WITNESS WHEREOF, the parties have signed this Amendment as of its
effective date.
UROLOGIX, INC. BOSTON SCIENTIFIC CORPORATION
By /s/ Xxxxxx X. Xxxxxxx, Xx. By /s/ Xxxx X. XxXxxxxxxx
----------------------------------- -------------------------------
Its: CFO Its: President, International
------------------------------- ---------------------------
Dated: March 1, 1999 Dated: February 26, 1999
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Exhibit I
Description of Products Inventory at Beek, Netherlands
and
[Confidential Treatment Requested] Control Units Described in Section 4.8
Beek Inventory
[Confidential Treatment Requested]
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Exhibit II
Current Plan
[Confidential Treatment Requested]
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Exhibit III
Market Development Amount Payments
[Confidential Treatment Requested]
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Exhibit IV
Quarterly Targets
[Confidential Treatment Requested]
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Exhibit V
Expense Categories
Under Section 5.1
[Confidential Treatment Requested]
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Exhibit 10.1 - CONFIDENTIAL TREATMENT REQUESTED
--------------------------------
Certain information has been omitted from this exhibit
and filed separately with the Commission pursuant to a
request for confidential treatment under Rule 24b-2
Exhibit VI
Existing Regulatory Approvals
Approved
--------
Argentina
Australia
Canada
European Union
Submitted and Waiting for Approval
----------------------------------
Brazil
Taiwan
Korea
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