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EXHIBIT 10.2
(CRYOCATH LOGO)
DISTRIBUTION AGREEMENT
THIS DISTRIBUTION AGREEMENT (the "Agreement") is made as of
November 9th ,
2004, (the "Effective Date") by and between CRYOCATH
TECHNOLOGIES INC., a
corporation organized and existing under the laws of Quebec,
Canada, with its
principal offices at 16771 Chemin Ste-Marie, Kirkland (Quebec)
Canada H9H 5H3
(hereinafter referred to as "Manufacturer" or "CryoCath"), and
ATS Medical,
Inc., a corporation organized and existing under the laws of
Minnesota with its
principal offices at 3905 ANNAPOLIS LANE, SUITE 105,
MINNEAPOLIS, MN 55447
U.S.A., (hereinafter referred to as "Distributor").
In consideration of the mutual promises contained herein and for
other good
and valuable consideration, the receipt and sufficiency of which
are hereby
acknowledged, the parties hereto agree as follows:
ARTICLE 1. DEFINITIONS
As used in this Agreement, the terms set forth in this Article 1
shall have
the following meanings:
1.1 Products. Products shall mean those products listed in
Exhibit A
attached hereto, as amended from time to time by the
Manufacturer and
communicated in writing to Distributor.
1.2 Territory. Territory shall mean all countries except for
USA,
Italy, , Australia, Sweden, Denmark, Finland, Luxemburg, Spain,
Portugal,
Hungary, and the Czech Republic, Slovakia, Norway, Iceland,
Mexico.
1.3 Contract Quarter. Contract Quarter shall mean a period of
three
consecutive calendar months beginning on January 1, April 1,
July 1, or
October 1.
1.4 Purchase Commitment shall have the meaning set forth in
Section
3.2.
1.5 Standard Terms and Conditions of Sale. Standard Terms
and
Conditions of Sale shall mean Manufacturer's terms and
conditions of sale
for its products, as modified by Manufacturer from time to time
and
communicated in writing to Distributor.
1.6 Trademarks. Trademarks shall mean those trademarks and
trade
names, whether registered in the Territory or not, labeling,
trade dress,
packaging and devices which are owned by, licensed or assigned
to
Manufacturer or which it otherwise has aright to use and which
are applied
to or used with the Products by Manufacturer
** The appearance of a double asterisk denotes confidential
information that
has been omitted from the exhibit and filed separately,
accompanied by a
confidential treatment request, with the Securities and Exchange
Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of
1934.
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ARTICLE 2. APPOINTMENT: EXCLUSIVITY; COMPETING PRODUCTS;
PRICES
2.1 Appointment. Subject to the terms of this Agreement,
Manufacturer
appoints Distributor as its exclusive distributor of the
Products in the
Territory in accordance with the terms of this Agreement and
Distributor
accepts this appointment. Such appointment does not constitute a
grant of
any rights or interests other than the rights specifically
granted to the
Distributor hereunder and does not constitute a license or
sub-license of
the Products. If the Distributor fails to meet the Purchase
Commitment,
Distributor's appointment will automatically become
non-exclusive for the
remaining term of this Agreement, as set forth under Section
3.2.
2.2 Exclusivity. Subject to Distributor's compliance with the
terms of
this Agreement, Manufacturer shall sell the Products for
delivery in the
Territory only to Distributor.
2.3 Promotion and Sale of Products only within Territory.
Distributor
shall promote and sell the Products to customers only for use
or
consumption within the Territory.
2.4 Competing Products. Manufacturer or Distributor shall
neither
distribute nor market products competitive with the Products
during the
Term as defined in Section 17.1 and any renewal of this
Agreement without
the prior written consent of either Party. It is understood
that
Manufacturer is restricted from selling Products in Agent's
Territory
during the term of the Agreement. If either Party does not
approve the
other Party's request for representation of competitive
products, the other
Party must refuse to or cease representing the competitive
products.
Distributor shall not make any changes, alterations,
modifications or
additions to the Products without the prior written approval of
CryoCath.
2.5 Prices. Manufacturer shall sell Products to Distributor at
prices
previously communicated in writing by Manufacturer to its
Product
distributors generally from time to time. Subject to the
Purchase
Commitment as described in Section 3.2, the prices to be charged
to the
Distributor initially under this Agreement will be the prices
set out in
Exhibit A under "Distributor Price". A price adjustment will be
made by
Distributor with payment made to Distributor or deducted from
payments owed
by Distributor on the 30th day following the preceding quarter
to which it
applies. ** With respect to resale prices to be charged by
Distributor to
customers, Distributor shall have the right to determine the
price of the
Products within the Territory but will be guided by the prices
listed for
the Products in Exhibit A. Notwithstanding the generality of the
foregoing,
Distributor will not sell Products at prices below the
Distributor Price in
Exhibit A, as amended from time to time, without prior written
approval
from Manufacturer.
ARTICLE 3. PROMOTION AND SALE OF PRODUCTS
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3.1 Commercially Reasonable Efforts. Distributor shall exercise
its
commercially reasonable efforts to promote and sell the Products
for use
only by qualified individuals as appropriate in the Territory,
in
compliance with local laws and regulations and good commercial
practice and
for uses and applications reasonably approved by Manufacturer
for the
Products. Distributor shall only sell directly to end users of
the Products
and shall not sell indirectly or engage sub-distributors without
the prior
written consent of Manufacturer. Distributor shall be subject
to
performance criteria applied to distributors of the Products in
general, as
communicated in writing by Manufacturer from time to time, after
discussion
and agreement with the Distributor. Manufacturer shall use
commercially
reasonable efforts to promptly obtain and maintain government
approvals to
import, register and market the Products in each jurisdiction in
the
Territory. The decision to obtain government approvals in each
jurisdiction
in the Territory will be made jointly based on the economic
viability for
both parties of marketing products in such jurisdictions. Such
decisions
may require agreement to special adjustments referred to in
Section 2.5
determined on a jurisdiction-by-jurisdiction basis. In the event
that a
decision is made jointly not to pursue marketing of products in
a given
jurisdiction under this agreement, then Manufacturer may at his
option be
permitted to market products in such jurisdiction directly or
indirectly
without the Distributor. Distributor will diligently secure and
maintain,
as may be required from time to time, government importing,
import and
export licenses, customs clearances and currency authorizations
and any
other permits necessary in each jurisdiction in the Territory.
Manufacturer
will diligently secure and maintain, as may be required from
time to time,
government registration and marketing approvals in each
jurisdiction in the
Territory and shall submit to the government health authorities
in each
jurisdiction in the Territory where the sale of the Products is
agreed to a
complete application for registration and marketing plan.
3.2 Purchase Commitment. In addition to the commercially
reasonable
efforts commitment described herein, Distributor hereby agrees
to purchase
from CryoCath ("Purchase Commitment") and for each renewal year
term
thereafter, the dollar value in Products set forth on the
Purchase
Commitment, Exhibit C. Distributor must meet the annual
Purchase
Commitments at the end of each twelve-month term and must meet
40% of the
first term's commitment by the end of the first 9 months of that
first term
and 40% of the second term's commitment by the end of the first
nine months
of the second term (hereafter referred to as the "Interim Term
Targets").
It is understood that the initial period referred to with
respect to the
interim and annual purchase commitments will be for 15 months
and will
commence as of January 1, 2005. Subsequent periods will be for
twelve
months commencing on April 1, 2006 and April 1 each year
thereafter.
CryoCath shall transfer to Distributor as of January 1, 2005 all
its
existing customer accounts it has in the Territory identified in
Section
1.2.. Distributor shall pay a one time compensation fee to
CryoCath for the
transferred accounts on January 1, 2005 an amount equal to
**
Throughout the term of this Agreement, if Distributor fails to
purchase
Distributor's Purchase Commitment at any time or meet the
Interim Term Targets,
Distributor's appointment may at CryoCath's option, be
terminated or may
automatically become non-exclusive for the remaining
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term of this Agreement subject to a 30-day cure period, without
prejudice to
CryoCath's other rights under this Agreement (including the
right to terminate
this Agreement upon written notice to Distributor) and CryoCath
may appoint one
or more additional agents or Distributors for sale of the
Products or solicit
orders for the Products directly in the Territory for the
remaining term of this
Agreement. Products returned to CryoCath for reason other than
Product defect
shall not count towards the fulfillment of Distributor's
relevant Purchase
Commitment. Purchase Commitments for the second twelve-month
period are to be
negotiated mutually between the parties 6 months prior to the
expiration of the
First Twelve Month Period such that ** Purchase Commitments will
be adjusted as
new jurisdictions are added during the term of this agreement.
Throughout the
term of this Agreement, if Distributor fails at any time to
purchase
Distributor's Purchase Commitment or meet the Interim Term
Targets,
Distributor's appointment may at CryoCath's option,
automatically become
non-exclusive for the remaining term of this Agreement subject
to a 30-day cure
period, without prejudice to CryoCath's other rights under this
Agreement
(including the right to terminate this Agreement upon written
notice to Agent)
and CryoCath may appoint one or more additional agents or
Distributors for sale
of the Products or solicit orders for the Products directly in
the Territory for
the remaining term of this Agreement. Products returned to
CryoCath for reason
other than Product defect shall not count towards the
fulfillment of
Distributor's relevant Purchase Commitment. The Purchase
Commitment in year two
of the term of this Agreement will be established by
Manufacturer in
consultation with Distributor after the third Contract Quarter
and will be
confirmed in writing by the Manufacturer prior to the
commencement of year 2 and
similarly for each renewal period thereafter.
3.3 Facilities. Subject to Article 16 hereof, Distributor
shall
maintain, lease or contract with such offices, warehouses, and
sales
facilities as are necessary to fulfill its duties under this
Agreement.
3.4 Personnel. Distributor shall maintain such competent and
qualified
sales and service personnel as are required to meet its duties
under this
Agreement. Manufacturer agrees to train the individual
responsible for
training Distributor's personnel in each major jurisdiction. In
all cases,
such training will take place at Manufacturer's offices or at a
place and
times agreed to by Manufacturer.
3.5 Inventories. Distributor shall, at Distributor's own
expense,
maintain a sufficient inventory of the Products at all times
during the
term of this Agreement as necessary to meet the requirements of
any
customer or potential customer within the Territory. Without
restricting
the generality of the foregoing, Distributor agrees to maintain
inventory
levels at not less than ** of forecasted requirements.
3.6 Promotional Materials. In promoting the Products in the
Territory,
Distributor shall not use promotional materials contrary to the
best
interest of the Manufacturer. Manufacturer reserves the right to
require
prior approval of the promotional materials and advertising
campaigns.
Manufacturer will provide to Distributor reasonable amounts of
such
promotional materials that it provides to its own
representatives, at no
cost. Certain promo materials will be available at cost.
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3.7 Reports. Commencing on the first day of the second
Contract
Quarter after the Effective Date, Distributor shall provide
Manufacturer on
the fifteenth day of each Contract Quarter with a written report
containing
information concerning the following:
(a) Distributor's sales volumes and prices in each country
for
each of the Products for the preceding Contract Quarter;
(b) Distributor's promotional activities regarding the
Products
for the preceding Contract Quarter;
(c) a summary of current market conditions for the Products,
including information concerning introductions, promotional
activities
and sales levels of products competitive with the Products;
(d) forecasts of prospective purchase orders and anticipated
sales volumes for the Products during the succeeding two
Contract
Quarters; and
(e) forecasted purchase order submission dates.
3.8 Warranties. Manufacturer's standard warranty of its Products
shall
apply to the sale of the Products to Distributor as contained
in
Manufacturer's terms and conditions of sale, as may from time to
time be
modified by Manufacturer, and Distributor shall extend such
warranty to its
customers. Manufacturer shall honor the claims of Distributor's
customers
within the limits of the warranties offered by Manufacturer to
Distributor.
Distributor shall offer no other warranties concerning the
Products without
the prior written authorization of Manufacturer.
3.9 Customer Complaints. Distributor shall report to
Manufacturer no
later than within 48 hours of receipt all customer complaints of
any nature
concerning the Products and all notices of serious or adverse
reaction
associated with the use of the Products, and cooperate with
Manufacturer in
the resolution of such complaints. Distributor shall maintain
records of
such complaints for at least two years after their receipt and
shall make
such records available to Manufacturer for inspection and
copying upon
Manufacturer's request at any time during Distributor's normal
business
hours.
3.10 Assistance of Government Officials. Without Manufacturer's
prior
written approval or as required by law, Distributor shall not
hire, retain,
or make payment of any kind to government or regulatory
officials of the
Government of the Territory or of any jurisdiction within the
Territory, or
their relatives to assist Distributor in marketing the
Products.
3.11 Storage Practices, etc. Distributor shall conform its
sales,
storage and quality control practices to those written standards
provided
by Manufacturer to Distributor from time to time.
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3.12 Sales Records. Distributor shall prepare accurate and
orderly
business and accounting records concerning its inventories and
sales of the
Products. Distributor shall maintain these records for a period
of at least
two years after the Contract Quarters to which they apply.
Distributor
shall provide Manufacturer with copies of such records within
fifteen (15)
days of any written request by Manufacturer. Manufacturer may
request, and
Distributor agrees to comply with such request, an audit of
Distributor's
sales records for the purpose of verifying the accuracy of
Manufacturer's
price charged to Distributor through out the life of the
Agreement.
Manufacturer will be responsible for the cost of such audit
provided that
Distributor's records reflect actual end user sales to within
98%. In the
event that the audit reveals accuracy of such records to be
lower than 98%,
Distributor will bare the cost of such audit.
3.13 Shelf Life. Distributor shall maintain its inventory so as
to
sell the Products only during their applicable shelf lives as
communicated
to Distributor by Manufacturer from time to time. Manufacturer
shall not be
obligated to compensate Distributor for Products that
Distributor is unable
to sell within or after their shelf lives.
3.14 Inspections. During Distributor's normal business
hours,
Distributor shall permit representatives of Manufacturer after
reasonable
notice to inspect Distributor's facilities and inventory to
ensure that
Distributor is meeting applicable quality control standards and
otherwise
exercising its best efforts in storing, promoting, selling and
delivering
the Products.
3.15 Samples. The Manufacturer shall supply the Distributor with
** at
Manufacturer's fully absorbed cost and a reasonable number of
surgical
consoles not for human use at **.
Conference and Marketing Booth. Distributor agrees to attend the
following
conferences (ATS to attach list) each year for the promotion of
Products. In
addition, Agent agrees to dedicate 25% of its Marketing booth
sales
representative stations to CryoCath. CryoCath agrees to display
ATS's name as
Distributor of its Products in its booth at such Surgical
conferences that it
attends and at which it has booth space.
ARTICLE 4. MANUFACTURER ASSISTANCE TO DISTRIBUTOR
To assist Distributor in registering and marketing the Products
in the
Territory, Manufacturer shall:
(i) Provide Distributor with materials necessary to obtain
health
registrations, to the extent practicable. Such documentation
shall be
provided in English. Translation expense will be borne by
the
Distributor.
(ii) Provide Distributor with information on marketing and
promotional
plans with respect to the Products as well as copies of
marketing,
advertising, sales and promotional literature concerning the
Products
produced by or for CryoCath, if any. Such documentation shall
be
provided in English. Translation expense will be borne by
the
Distributor.
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(iii) Provide Distributor with certain certificates of analysis
concerning
the Products purchased by Distributor, certificates of free
sale,
trademark authorizations and any other documents which
Distributor may
require for registration purposes, at Distributor's request
and
expense, if available. Such documentation shall be provided
in
English. Translation expense will be borne by the
Distributor.
(iv) Provide Distributor with Field Service Manual, Field
Service
Procedures and requisite forms required to service CryoCath
Products,
as amended from time to time by CryoCath. Such documentation
shall be
provided in English. Translation expense will be borne by
the
Distributor.
(v) Distributor agrees subject to the terms identified in
Section 17 of a
Termination or Early Termination of this agreement that
Distributor
will transfer at Manufacturer's cost all registration and
regulatory
files of Product's to Manufacturer.
ARTICLE 5. ADDITION AND DELETION OF PRODUCTS FROM AGREEMENT
5.1 Addition of Products. From time to time new Products may be
added
to those covered by this Agreement by amendment of Exhibit A in
accordance
with Article 18.7.
5.2 Deletion of Products. Manufacturer may delete specific
Products,
provided such Products are replaced with next generation
Products, from
coverage by this Agreement upon (30) thirty-day written notice
to Agent,
which notice includes an amendment of the attached Exhibit A
reflecting the
deletion. No such deletion shall be deemed a termination or
partial
termination of this Agreement.
Manufacturer's address. Distributor shall mail or fax all orders
for
the Products to the following address:
CryoCath Technologies Inc.
16771 Chemin Ste-Marie
Kirkland, Quebec H9H 5H3
Canada
Attention: Customer Service
Fax: 1-514-694-6279
or to such other address or facsimile number as Manufacturer
shall from
time to time designate in writing.
5.3 Information in Distributor's Orders. In connection with each
order
of Products, Distributor shall provide Manufacturer with the
following
information:
(a) purchase order number;
(b) billing address;
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(c) name, list number, and quantity of Products being
ordered;
and
(d) preferred warehouse of delivery.
5.4 Precedence of Agreement over Purchase Orders. In the event
of
conflict between the terms of this Agreement and the terms of
any purchase
order form or other document submitted by Distributor to
Manufacturer in
connection with any order for the Products, this Agreement shall
control
unless the parties specifically otherwise agree in writing.
ARTICLE 6. TERMS AND CONDITIONS OF SALE AND DELIVERY OF
PRODUCTS;
NON-CONFORMING AND NON-DELIVERED PRODUCTS
6.1 Acceptance of Orders. All orders for Products submitted
by
Distributor shall be initiated by written purchase orders sent
to CryoCath
and shall request a delivery date during the term of this
Agreement;
provided however that an order may initially be placed orally or
by
facsimile. A written or facsimile confirmation purchase order is
to be
received by CryoCath within twenty-four (24) hours after an oral
order is
placed. No order shall be binding upon CryoCath until accepted
by CryoCath
in writing, and CryoCath shall have no liability to Distributor
with
respect to purchase orders that are not accepted. No partial
shipment of an
order shall constitute the acceptance of the entire order.
CryoCath shall
use commercially reasonable efforts to deliver Products at the
times
specified either in CryoCath's quotation or in CryoCath's
written
acceptance of Distributor's purchase orders. CryoCath will send
a facsimile
acceptance or non-acceptance of purchase orders within two
business days.
6.2 Taxes, Stamp , Duties, Prices and Currency; Charges for
Handling,
Shipping and Insurance. All sales of the Products to Distributor
under this
Agreement shall be at Manufacturer's then- current prices, in
U.S. dollars,
as reflected on Exhibit A. Manufacturer may
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