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DISTRIBUTOR AGREEMENT

Distribution Agreement

DISTRIBUTOR AGREEMENT | Document Parties: FISCHER IMAGING CORP | SILICON VALLEY BANK | Ethicon Endo-Surgery, Inc., You are currently viewing:
This Distribution Agreement involves

FISCHER IMAGING CORP | SILICON VALLEY BANK | Ethicon Endo-Surgery, Inc.,

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Title: DISTRIBUTOR AGREEMENT
Governing Law: New York     Date: 4/15/2004
Industry: Medical Equipment and Supplies     Sector: Healthcare

DISTRIBUTOR AGREEMENT, Parties: fischer imaging corp , silicon valley bank , ethicon endo-surgery  inc.
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Exhibit 10.8


DISTRIBUTOR AGREEMENT

        This AGREEMENT ("Agreement") dated as of December 9, 1998, by and between Ethicon Endo-Surgery, Inc., an Ohio corporation ("EES"), and Fischer Imaging Corporation, a Delaware corporation ("Fischer").

Preliminary Statement

        Fischer is in the business of manufacturing and selling, among other products, stereotactic X-ray equipment and desires to appoint a distributor regarding such products in the Exclusive Territory and the Non-Exclusive Territory (as defined below).

        EES wishes to be appointed as a distributor of the Products in the Exclusive Territory and Non-Exclusive Territory as more fully described below.

        Pursuant to an Agreement dated October 10, 1997, between EES and Fischer (the "1997 Agreement"), Fischer and EES set forth a commercial relationship including the grant by Fischer to EES of an option to distribute Fischer's stereotactic X-ray imaging products on a non-exclusive basis worldwide. To date, EES has not exercised this option but Fischer and EES wish to expand their current relationship through this Agreement.

        ACCORDINGLY, the parties hereto agree as follows:

ARTICLE I
DEFINITIONS

        As used herein, the following defined terms shall have the meanings set forth in this Article 1:

        Section 1.01    "Affiliate" of a party hereto shall mean another party that controls, is controlled by, or is under common control with such party hereto, and for such purpose "control" shall mean the possession, direct or indirect, of 50% or more of voting power or beneficial interest in equity in the entity, whether through the ownership of voting securities, by contract or otherwise.

        Section 1.02    "Exclusive Territory" shall mean the countries of Germany and Italy.

        Section 1.03    "Initial Term" shall mean the period commencing on the date hereof and ending 24 months later. For the purposes of this Agreement, the Initial Term shall be divided into two parts, the First Half and the Second Half. The "First Half" shall mean the first 12 months of the Initial Term, and the "Second Half" shall mean the last 12 months of the Initial Term.

        Section 1.04    "Non-Exclusive Territory" shall mean as of the date hereof the countries of the continent of Europe (excluding the countries of Germany and Italy), the countries of the region known as the Middle East and the country of South Africa, with such additions or deletions during the term of the Agreement as are mutually agreed.

        Section 1.05    "Products" shall mean the products meeting the Specifications set forth in Exhibit A hereto and any or all improvements thereto.

        Section 1.06    "Specifications" shall mean the specifications for the Products. The initial specifications for the Products are set forth in Exhibit A hereto.

        Section 1.07    "Year 2000 Compliant" shall mean:

        (a)   a Product performs in a consistent manner and functions without interruptions regardless of the date in time on which the Product is delivered, used and/or further distributed, whether before, on or after January 1, 2000 and whether or not the dates are affected by leap years;


        (b)   a Product, if computerized, accepts, calculates, compares, sorts, extracts, sequences and otherwise processes date inputs and date values, and returns and displays date values and performs, in a consistent manner regardless of the dates used, whether before, on or after January 1, 2000;

        (c)   a Product, if computerized, accepts and responds to two-digit year-date input where applicable in a manner that resolves any ambiguities as to the century in a defined, predetermined and appropriate manner;

        (d)   a Product, if computerized, stores and displays date information in ways that are unambiguous as to the determination of the century; and

        (e)   a Product shall be delivered in a timely manner without interruptions caused by the date in time on which the product is ordered or is actually delivered or the services are scheduled or actually performed under normal procedures in the ordinary course, whether before, on or after January 1,2000.

ARTICLE II
APPOINTMENT

        Section 2.01     Appointment.     Subject to all of the terms and conditions of this Agreement, Fischer hereby appoints EES as, and EES hereby accepts such appointment, as:

        (a)   the authorized, independent Distributor of the Products in the Exclusive Territory. EES shall have exclusive distribution rights in the Exclusive Territory for the Products during the Initial Term. Such exclusive distribution rights shall continue:

          (i)  during the Second Half of the Initial Term so long as EES sells a minimum of ten new stereotactic tables in the Exclusive Territory and Non-Exclusive Territory combined during the First Half of the Initial Term, and

         (ii)  during each subsequent 12 month period of the remainder of the Term (as defined in Section 9.01 below) so long as EES sells a minimum of ten new stereotactic tables in the Exclusive Territory and Non-Exclusive Territory combined during the previous 12 month period.

If EES does not meet the requirements for exclusivity set forth above, the right of EES to distribute the Products in the Exclusive Territory shall be converted to non-exclusive rights during the subsequent 12 month period. While EES meets the requirements for exclusivity set forth above, Fischer and its Affiliates may not themselves, nor may they appoint a distributor or cause an existing distributor to, sell and distribute new or used Products in the Exclusive Territory.

        (b)   the authorized, independent distributor of the Products in the Non-Exclusive Territory. EES shall have non-exclusive distribution rights in the Non-Exclusive Territory for the Products during the Term. Except for any pre-existing agreements it is a party to, Fischer agrees during the Term of this Agreement that it will not offer to any other distributor or dealer in the Non-Exclusive Territory (or the Exclusive Territory during any period when the exclusivity requirements are not met) terms more favorable than those offered to EES in this Agreement.

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        Section 2.02     Payments to Fischer.     During the Term of the Agreement, EES agrees to pay Fischer the following amounts within seven days of the occurrence of the contingencies set forth below:

          (i)  $200,000 at signing of this Agreement,

         (ii)  $100,000 after written certification by Fischer that (A) all three of the individuals based in Germany with respect to the Fischer European Infrastructure (as referred to in Section 4.08 hereof) have commenced full-time employment with Fischer, and (B) an authorized representative of EES Europe certifies that Fischer has a reasonable inventory of service spare parts located in Europe, and

        (iii)  $300,000 upon the 1 st day of the Second Half of the Initial Term if an Event of Default has not occurred.

These amounts are one time payments.

        Section 2.03     Relationship of the Parties.     The relationship established hereby is that of independent contractors and not that of principal and agent.

        Section 2.04     Price.     

        (a)   From the date hereof through the expiration of the Initial Term, the transfer prices with respect to new Products to be distributed by EES pursuant to this Agreement shall be as set forth in Exhibit B.

        (b)   Six months prior to the expiration of the Initial Term, Fischer shall initiate discussions by written notice to EES for the parties to negotiate in good faith the prices for the Products, the Rebate (as defined in Section 2.07 below), if any, and other appropriate terms and conditions to be applicable for the remainder of the Term of the Agreement. The failure by the parties to agree on the prices for the Products, the Rebate or other appropriate terms and conditions for the remainder of the Term prior to the expiration of the Initial Term shall result in the automatic termination of this Agreement upon the expiration of the Initial Term.

        (c)   For a new table Product sold in the Non-Exclusive Territory, EES agrees to pay an extra $10,000 per table to be added to the transfer price to cover service warranty and installation by Fischer or its designee. Where the table is installed and the service warranty is performed by a designee of Fischer, Fischer agrees to pay the entire $10,000 payment to such designee.

        Section 2.05     Applications Training.     Fischer shall be responsible for all customer applications training ("Applications Training") for the Products as set forth in Exhibit C attached hereto. If EES desires Fischer to provide additional Applications Training, EES shall notify Fischer of such desire in writing. Fischer agrees to promptly provide such additional training to be billed at a reasonable cost to the relevant EES Affiliate.

        Section 2.06     Transmittal of Orders; Delivery.     

        (a)   Fischer acknowledges that EES is relying on Fischer to make on time delivery of Products sold pursuant to this Agreement. Fischer shall use all reasonable efforts to ensure that orders for Products, when ordered by EES, are promptly filled but in any event within 60 days of receipt of the order or other specific delivery date as mutually agreed upon in writing. Fischer shall not be responsible for paying any financial penalties due to late delivery of an order unless it or an authorized representative specifically agreed in writing to the imposition of such penalty in advance of accepting the purchase order for such Product.

        (b)   Delivery of the orders is FOB Fischer's Denver manufacturing facility.

        (c)   After the Product or Products have been delivered to EES, Fischer shall invoice EES in its usual manner. EES agrees to pay Fischer 50% of the amount due within 30 days of the Product

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being invoiced, and the remainder within 30 days after (i) installation of the Product, (ii) completion of Applications Training, and (iii) the obtaining of all site approvals; but in any event not longer than 60 days after invoice of the Product to EES.

        Section 2.07     Rebate in Exclusive Territories.     

        (a)   EES agrees that after the sale by it of an aggregate of 10 new tables in the Exclusive Territory in each of the two consecutive periods of the Initial Term, then with respect to the sale of any additional Mammotest Plus S tables in the Exclusive Territory with an Actual Selling Price (as defined below), greater than [****], EES shall pay to Fischer a rebate (the "Rebate").

        (b)   For purposes of this Section, the "Actual Selling Price" shall be calculated by adding together the combined customer invoice price of the table and any Options (as defined in Exhibit B) sold with the table and deducting from such sum the total of the following amounts to the extent they are actually paid by EES or its Affiliates: (i) any goods and service or value added taxes (by whatever name known), and (ii) the Option Rebate Calculation Price (as defined in Exhibit B) for each of the Options sold with the table.

        (c)   If the Actual Selling Price is greater than [****], EES shall pay 50% of the difference between the Actual Selling Price and [****] up to a maximum rebate of [****] to Fischer. The Rebate is payable by EES 30 days after receipt by EES of the complete payment for the table from the customer, at which time the calculations above shall be converted into U.S. dollars at the prevailing spot market exchange rate to see if the Actual Selling Price exceeded [****].

****Represents material which has been redacted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

ARTICLE III
RESPONSIBILITIES OF EES

        Section 3.01     Forecasts.     In order to facilitate Fischer's timely manufacture of Product, within ninety (90) days after the execution and delivery of this Agreement, and at the beginning of every calendar quarter thereafter, EES shall submit on a quarterly basis a good faith, rolling twelve-month forecast of the estimated requirements of Product during the subsequent twelve (12) month period, it being agreed such forecasts shall not be legally binding.

        Section 3.02     Promotional Efforts; Materials; Claims; Trademarks.     EES agrees to promote the Products on customer calls and at trade shows conducted within the Exclusive Territory and the Non-Exclusive Territory to the extent set forth below. EES shall utilize the Demonstration Model Table (as defined in Article 7 below) to promote the Products at trade shows. Fischer agrees to cover all shipping and set-up expenses for the following trade shows on an annual basis: the European Congress of Radiology, and one other trade show in Europe to be decided at the discretion of EES which may be changed by it from year to year upon written notification to Fischer. EES agrees to cover all shipping and set-up expenses for all other trade shows. EES shall not make any claims in the advertising and promotion of the Products other than those provided by Fischer or approved in advance in writing by Fischer. EES shall acquire no rights in any trademarks, tradenames, or service marks of Fischer, and shall not use any of the foregoing except to the extent included in advertising and promotional materials provided or approved by Fischer.

        Section 3.03     Customer Technical Service.     Fischer shall have exclusive responsibility for providing customer technical support and service. Such services shall be with respect to the operation and application of the Products. EES shall enable Fischer to perform such service by providing information regarding the customer to Fischer on a timely basis.

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        Section 3.04     Recalls.     EES agrees to cooperate with Fischer to enable Fischer to satisfy its obligations as the licensed manufacturer of the Products with respect to any recall or corrective action relating to the Products.

        Section 3.05     Customer Complaints.     EES shall immediately notify Fischer in a manner reasonably requested by Fischer should it become aware, through customer complaint or otherwise, of any defect or condition which may render the Product in violation of any law or governmental regulatory requirement, or which may in any way deviate from the quality requirements (set forth in Section 4.01 below) or warranties for the Product.

ARTICLE IV
RESPONSIBILITIES OF FISCHER

        Section 4.01     Quality.     Fischer shall manufacture the Products in compliance with the Specifications and all applicable laws, rules and regulations and shall maintain the quality of the Product and attempt to upgrade such quality as necessary to maintain market competitiveness within the frame work of the Specifications.

        Section 4.02     Translations.     Fischer agrees to obtain translations of the operators manuals, and other appropriate labeling of the Products in compliance with the European Medical Device Directives and applicable national laws, such translations to be in German, French, Italian and a fourth language to be mutually agreed upon. Any further language translations shall be considered for joint funding based upon market analysis and mutual agreement.

        Section 4.03     Market Support.     Fischer shall make available to EES at its request reasonable quantities of brochures, catalogues, sales aids and other marketing material as Fischer shall have produced with respect to the Products and is then distributing generally to its sales personnel.

        Section 4.04     Product Service.     All customer product service and extended warranty or service contracts shall be the responsibility of Fischer. Fischer agrees to make these service choices available to all customers who purchase Products from EES pursuant to the terms of this Agreement. The level of product service support to be offered for the NonExclusive Territory and the Exclusive Territory is detailed in Exhibit D. If for whatever reason, whether during or after the Term of this Agreement, Fischer can no longer provide product service to the customers of EES, abandons the market, or provides an inadequate level of product service support (to be quantitatively determined against the criteria detailed in Exhibit D), EES shall have the option of assuming (either directly or indirectly, through a contracted third party) the right to provide customers of EES with product service for the Products by giving 30 days advance written notice to Fischer. If EES exercises such option, Fischer shall transfer to EES, with respect to the Products sold pursuant to this Agreement, (i) all service records, (ii) all service and operators manuals, (iii) a license to any software code or trademarks as solely required to extend service to EES customers, (iv) any product drawings required to render service, (v) all component specifications as may be required to provide service to existing customers of the Products, and with respect to said components grant hereby a license to make, have made, use or sell such components as solely required to provide service to existing customers of the Products, (vi) any other technical know-how necessary to service the Products, and (vii) access to the source of supply of any of the above. In addition, Fischer agrees to sell at its standard dealer net cost all spare parts on hand in Europe to EES, and provide access to EES to the suppliers of such parts to allow a continued source of supply.

        Section 4.05     Sales Training.     Fischer shall provide, at no charge to EES, initial Product training to the marketing and sales organizations of EES and its Affiliates with responsibility for distribution of the Products in the Non-Exclusive Territory and Exclusive Territory. Such product training shall include, but not be limited to, product features and benefit training, and other market position training. Such training shall not exceed six (6) full days and shall require no more than three (3) sessions in order to

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facilitate training for 35 to 40 individuals in groups of 12 to 15 people. EES shall bear all expenses incurred by its personnel during such training.

        Section 4.06     Customer Complaints, FDA audits, EES Inspections.     Fischer shall immediately notify EES in writing should it become aware, through customer complaint or otherwise, of any defect or condition which may render the Products in violation of law or any government applicable regulations, or which may in any way deviate from the quality, specifications or warranties for the Products. In accordance with the Medical Device Reporting ("MDR") and Medical Devices Vigilance ("MDV") system of the United States Food and Drug Administration (FDA) and all equivalent/applicable EU Directives/national laws and regulations, Fischer shall maintain responsibility for (i) managing all customer complaints or product inquires, (ii) reporting to government agencies and (iii) all corrective action where appropriate. Fischer agrees to notify EES as soon as practical after Fischer becomes aware of any FDA audit (or of any audit from a regulatory agency in another country), or of any request for information from the FDA (or a regulatory agency in another Country) related to the manufacture or use of the Products. Fischer agrees that EES or its designated representative may at any time during business hours but subject to reasonable prior notice inspect the records referred to above or inspect the manufacturing facilities of Fischer with respect to the Products to ensure compliance with the provisions of this Agreement.

        Section 4.07     Indemnification.     Subject to the limitations set forth in Section 9.11, Fischer shall indemnify and hold EES and its affiliates, officers, directors, employees, sales representatives and agents (collectively, the "EES Agents") harmless against any and all claims, losses, damages, judgments, costs, awards, expenses (including reasonable attorney's fees and expenses) and liabilities of every kind (collectively "Losses" arising out of or resulting from (i) a claim from a third party that the manufacture, use and sale of existing Products infringes the proprietary rights of such third party, or (ii) the use of the Products; except to the extent such Loss is caused by the negligence or willful misconduct of EES or the EES Agents; provided that (i) EES informs Fischer promptly of any such Loss asserted against EES, (ii) Fischer shall have the right to control the defense against any such claim or action, and (iii) EES cooperates fully with Fischer in such defense.

        Section 4.08     Fischer European Infrastructure.     In order for Fischer to perform its obligations under this Agreement, Fischer agrees to employ a minimum of three employees to be based in Germany and one employee to be based in Italy (the "Infrastructure Employees"). The Infrastructure Employees in Germany shall include a Business/Technical Product Manager, an Applications Specialist, and a Service Engineer, and the Infrastructure Employee in Italy shall include a Service Engineer. The parties agree that while the final decision whether to hire an Infrastructure Employee rests with Fischer, EES shall be consulted and kept informed of progress by Fischer. It is understood that the four Infrastructure Employees are in addition to Fischer's existing Service Engineer based in Germany, and its Manager of Service Support based in Denmark (such employees, the "Existing Employees"). Fischer agrees to maintain the level of Infrastructure Employees and Existing Employees set forth above during the Initial Term, and to replace any such employee who leaves the employment of Fischer for whatever reason. After the expiration of the Initial Term, Fischer shall only be required to maintain the level of Infrastructure Employees and Existing Employees while EES is able to satisfy the requirements to maintain its exclusive distribution rights in the Exclusive Territory, as set forth in Section 2.01.

        Section 4.09     Recalls.     If Fischer shall request, or if any governmental agency having jurisdiction in the matter shall order, Fischer shall be required to institute and fund any recall, field corrective action, or the like.

        Section 4.10     Enhancements, Upgrades.     In the event Fischer modifies, enhances, upgrades or adds an option to a Product (including any "second-generation" or replacement product for a Product) (each, an "Upgrade") during the Initial Term or any extension of this Agreement, Fischer agrees to

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provide EES with such Upgrade in accordance with its then prevailing pricing policy regarding supply of the Upgrade to its other distributors and the Upgrade shall be deemed added to the definition of Products and pricing of Products contained in Exhibits A and B of this Agreement, respectively.

        Section 4.11     Changes Made to Products.     If a change is contemplated to any of the Products listed in Exhibit "A" (as amended from time to time) that would effect the form, fit, or function of the product or could potentially effect the safety or efficacy of a Product, such change must be notified to EES in writing 60 days in advance of implementing the change. During the term of this Agreement, Fischer agrees to maintain the design of the Products in a manner which is compatible with the functionality and design of the Mammotome Biopsys system of EES and subsequent improvements thereto. Further, Fischer shall not, without the prior written consent of EES, design, develop, manufacture or distribute any Products that substantially conform to the specifications and intended functionality of the Mammotome Biopsys system.

        Section 4.12     Regulatory Submissions.     Fischer either directly or through a designated third party shall prepare and maintain at Fischer's expense, all technical files and submissions necessary to obtain all necessary approvals or concurrences required to sell the Product in the Exclusive Territory and the Non-Exclusive Territory. With respect to the Non-Exclusive Territory, it is understood that such technical files and submissions will be prepared only upon written request from the relevant EES Affiliate, based on specific tender-quotation and or installation requirements.

        Section 4.13     Liability Insurance.     Fischer shall at its own expense maintain a policy or policies of commercial general liability insurance including product liability and contractual liability insurance during the entire term of the agreement and for as long as the Products are distributed. Such insurance shall include commercial general liability insurance in an amount not less that $1 million per occurrence and aggregate and product liability and contractual liability insurance in an amount not less than $10 million per occurrence and aggregate. The policies shall name Ethicon Endo-Surgery, Inc. as additional insured and shall provide 30 days written notice of cancellation or material change. Fischer shall provide annual certificates of insurance reflecting the required coverage.

ARTICLE V
REPRESENTATIONS AND WARRANTIES OF FISCHER

        Fischer represents and warrants to EES that:

        Section 5.01     Manufacturer of Product; Non-Infringement.     Fischer shall manufacture all Products in compliance with the Specifications and all applicable laws, rules and regulations, including good manufacturing practices (GMPs) of the FDA, and equivalent practices of regulatory agencies in other countries. All Products shall be free from defects in materials, workmanship or design and that to its best knowledge the manufacture, use and sale of the existing Products do not infringe the proprietary rights of any third party. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, FISCHER MAKES NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, IN RESPECT OF THE PRODUCTS.

        Section 5.02     Due Organization.     Fischer is a corporation duly organized and validly existing under the laws of the State of Delaware and is duly qualified to carry on its business in each country, state or other jurisdiction where the failure to so qualify would have a material adverse effect on its business or properties taken as a whole or the performance of its obligations contemplated hereby.

        Section 5.03     Binding Obligations.     Fischer has full power, authority and legal right to enter into and perform its obligations hereunder. This Agreement has been duly authorized, executed, and delivered by Fischer and constitutes the legal, valid and binding obligation of Fischer enforceable against Fischer in accordance with its terms.

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        Section 5.04     No Conflict.     The execution, delivery and performance of this Agreement and compliance with its terms by Fischer shall not result in a breach of any of the terms or conditions of, or result in the imposition of any lien, charge or encumbrance upon, any properties of Fischer pursuant to, or constitute a default under, any indenture, agreement or other instrument to which Fischer may be a party or by which Fischer may be bound.

        Section 5.05     Quality and Customer Service.     During the term of this Agreement, Fischer shall endeavor to maintain industry leading quality standards with respect to the manufacture, delivery and service of the Products sold pursuant to the terms of this Agreement.

        Section 5.06     Year 2000.     

        (a)   Fischer's Products are fully Year 2000 compliant, or it shall be able to demonstrate Year 2000 compliance and compliance in full production versions of such products, with accompanying documentation, no later than December 31, 1998;

        (b)   Fischer's information systems and other business systems for estimates, performance schedules, orders, confirmations, manufacture and delivery, invoicing, crediting of payments and other business operations shall accept and properly process input for dates before, on or after January 1, 2000 no later than December 31, 1998;

        (c)   the receipt of Year 2000 Compliant products and/or services shall be provided to EES under the Agreements in a timely and efficient manner without interruption and/or disruption at no additional fee or charge of any kind (including without limitation any installation, freight, or other costs or fees) to EES; and

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