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DISTRIBUTION AGREEMENT

Distribution Agreement

DISTRIBUTION AGREEMENT | Document Parties: ATS Medical, Inc | CRYOCATH TECHNOLOGIES INC You are currently viewing:
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ATS Medical, Inc | CRYOCATH TECHNOLOGIES INC

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Title: DISTRIBUTION AGREEMENT
Date: 5/10/2005
Industry: Medical Equipment and Supplies     Sector: Healthcare

DISTRIBUTION AGREEMENT, Parties: ats medical  inc , cryocath technologies inc
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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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