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NON-EXCLUSIVE DISTRIBUTORSHIP AGREEMENT

Distribution Agreement

NON-EXCLUSIVE DISTRIBUTORSHIP AGREEMENT | Document Parties: FISCHER IMAGING CORP | SILICON VALLEY BANK You are currently viewing:
This Distribution Agreement involves

FISCHER IMAGING CORP | SILICON VALLEY BANK

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Title: NON-EXCLUSIVE DISTRIBUTORSHIP AGREEMENT
Governing Law: New York     Date: 4/15/2004
Industry: Medical Equipment and Supplies     Sector: Healthcare

NON-EXCLUSIVE DISTRIBUTORSHIP AGREEMENT, Parties: fischer imaging corp , silicon valley bank
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Exhibit 10.11

EXECUTION COPY


NON-EXCLUSIVE DISTRIBUTORSHIP AGREEMENT

        This Distributorship Agreement (the "Agreement") dated as of October 10, 2002, is by and between ETHICON ENDO-SURGERY, INC., an Ohio corporation, of 4545 Creek Road, Cincinnati Ohio ("ETHICON"), and FISCHER IMAGING CORPORATION, a Delaware corporation, of 12300 North Grant Street, Denver, Colorado 80241-3120 ("FISCHER").

        WHEREAS, ETHICON already sells and desires to continue to sell the Products in the Territory for use in the Field (In each case, as defined below) during five term of this Agreement; and

        WHEREAS, ETHICON wishes to appoint FISCHER as its non-exclusive distributor of certain Products in the Territory for use in the Field on the terms and conditions set forth herein;

        WHEREAS, FISCHER desires to be appointed as ETHICON's non-exclusive distributor of the Products In the Territory for use in the Field on the terms and conditions set forth herein; and

        NOW, THEREFORE, in consideration of the premises and the mutual promises contained herein, the sufficiency of which is acknowledged by both parties, the parties hereto agree as follows:

        1.      DEFINITIONS . The following capitalized terms shall, except where the context otherwise requires, have the meanings specified below:

        (a)   "Affiliate" shall mean with respect to any party to this Agreement, any corporation or entity controlling, controlled by or under common control with such party, whether through the ownership of voting securities, by contract or otherwise.

        (b)   "FDA" shall mean the United States Food and Drug Administration or any successor or substitute agency having Federal regulatory health care responsibility for the Products and, where the context requires it, the equivalent governmental agency in any other country.

        (c)   "Field" shall mean the market for Tables in the Territory.

        (d)   "Products" shall mean the Mammotome® Biopsy system, and any accessories, and repair or service agreements related thereto and such modifications, enhancements and variations thereof, as more particularly described on Schedule 1(d) hereto, and "Product" shall mean any single Product.

        (e)   "Table" shall mean the MAMMOTEST® Stereotactic X-RAY Table manufactured and sold by Fischer from time to time during the term of this Agreement, including any variations, modifications, enhancements or upgrades thereof.

        (f)    "Territory" shall mean the territory described on Schedule 1(c).

        2.      RIGHTS TO PRODUCT .

        (a)    Appointment . Subject to the terms and conditions hereinafter set forth, and so long as this Agreement shall remain in effect, ETHICON hereby appoints FISCHER as a distributor for the Products in the Territory for use in the Field and FISCHER accepts such appointment and agrees to so act. FISCHER's right to offer the Products in the Territory for use in the Field is non-exclusive.

        (b)    Limit to Field . FISCHER agrees to use reasonable commercial efforts in good faith to sell the Product with each Table that it sells. In the event FISCHER sells a Table without a Product, it shall advise ETHICON within 30 days of the sale. FISCHER further agrees that it shall not, without the prior written consent of a ETHICON representative, directly or indirectly, offer, sell, resell, lease or promote Products outside the Field nor assist, directly or indirectly, any other party


 

to do so. The sale of the Product as a stand alone system without a Table would be considered a sale outside the Field for purposes of this Agreement. If any Products purchased by FISCHER hereunder are found to have been offered, sold, resold, leased or promoted by FISCHER outside the Field or outside the Territory or both without the prior written approval of ETHICON, it shall be considered a material breach of this Agreement.

        (c)    Third Parties . FISCHER shall have no right to appoint any sub-distributor or dealer for the Products or otherwise purport to grant any rights to the Products to any third party, without the prior written consent of ETHICON, including approval of the terms of any agreements creating any such relationship. Any such consent or approval shall be in the sole discretion of ETHICON.

        (d)    No Similar Products . During the term of this Agreement and in consideration for the grant of the appointment in Section 2(a) above, FISCHER shall not represent or offer for sale, or enter into any negotiation with any third party to represent or offer for sale any product or device for breast biopsy, other than the Product. Except as expressly set forth above, each of the parties acknowledges this Agreement is not intended to confer on the other party any right of exclusivity on or in connection with the subject matter of this Agreement.

        (f)     Other Products . Nothing herein shall be deemed to grant FISCHER any rights to market or distribute any products of any Affiliate of ETHICON or to restrict any Affiliate of ETHICON from marketing any products, other than the Product, in the Field.

        (g)    Discontinued Products . Nothing herein shall be deemed to prevent ETHICON from discontinuing the sale of any or all Products hereunder. In the event ETHICON elects to discontinue to offer any or all Products, this Agreement shall be terminated in respect of the discontinued Product or Products. Other than in a recall pursuant to Section 3(h), ETHICON shall give FISCHER 45 days prior written notice of its desire to discontinue a Product.

        (h)    Modifications, Enhancements, Upgrades . In the event ETHICON modifies, enhances or upgrades (each, an "upgrade") a Product during the term of this Agreement, ETHICON agrees to provide FISCHER with such upgrade in accordance with its then prevailing pricing policy regarding supply of the upgrade and the upgrade shall be included in the definition of Products.

        3.      FISCHER ORGANIZATION AND EFFORTS .

        FISCHER shall use diligent efforts in good faith to develop the market for and to sell the Products within the Field, and to such end:

        (a)    Training of Representatives . FISCHER shall be responsible for ensuring substantially all its field representatives offering or selling the Products and relevant administrative personnel who have oversight of the Products attend one or more training courses regarding the Products, at least one of which is to involve instruction by ETHICON, prior to such representative distributing the Products in the Field.

        (b)    Product Materials . In connection with distributing the Products, FISCHER agrees to use diligent efforts in good faith to ensure its representatives shall use only the Products' promotional materials provided by ETHICON. FISCHER acknowledges and agrees that it shall not develop, create, or use or cause its representatives to use any other promotional material or literature to offer the Products without the prior review and written consent of ETHICON. Any such consent or approval shall be in the sole discretion of ETHICON. FISCHER further agrees to use diligent efforts in good faith to cause its representatives immediately to cease offering promotional material when instructed in writing to do so by ETHICON. All ETHICON approved advertising by FISCHER shall be without recourse to ETHICON for any expense incurred unless such expense shall have been specifically authorized beforehand in writing by ETHICON.

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        (c)    Statements and Claims . FISCHER shall instruct its representatives to limit their statements, claims, representations and warranties regarding the Products, including efficacy and safety, to those which are consistent with the Products' FDA approved labeling and the Products' promotional materials.

        (d)    Compliance with Law . In the performance of all of its obligations hereunder, the exercise of its rights hereunder and its use, operation and storage of the Products, FISCHER shall comply with all applicable conventions, laws, rules, regulations and order of governmental authorities having jurisdiction over FISCHER and the Products. ETHICON agrees to advise FISCHER of any FDA or other regulatory changes and updates affecting the Products.

        (e)    Conventions and Trade Shows; Education . FISCHER agrees to consult with and to seek the prior written consent of ETHICON for any display relating to the Products at any convention or trade show that FISCHER proposes to attend during the term of this Agreement (a "Display Notice"). FISCHER further agrees to consult with and seek the prior approval of ETHICON for any course to educate customers and health care professionals about the Products that FISCHER may sponsor or promote during the term of this Agreement.

        (f)     Inventory Control . FISCHER shall be responsible for inventory control of the Products and sales reports. FISCHER will provide initial product traceability information to ETHICON as set forth in Schedule 3(f). This information shall be provided to ETHICON within 7 days of shipment of all Products.

        (g)    Adverse Experience Reporting . FISCHER shall, throughout the duration of this Agreement and for a period of 2 years after expiration or termination hereof, promptly notify ETHICON of receipt of any information its officers are aware of concerning any serious side effect injury, toxicity or sensitivity reaction or any unexpected incident, and the severity thereof, associated with the clinical use of the Products whether or not determined to be attributable to such Products. FISCHER shall also furnish reports of non-serious expected and non-serious unexpected adverse experiences associated with any Product which its officers become aware of. Nothing herein shall relieve FISCHER of its sole responsibility for reporting all adverse experiences with respect to the Products in conformance with all applicable laws and requirements of any governmental agency regulating the Field. The provisions of this Section shall survive the expiration, cancellation or termination of this Agreement.

        (h)    Recalls . If ETHICON shall request, or if any governmental agency having jurisdiction in the matter shall order, and ETHICON shall not timely contest, any change in or corrective action with respect to any Product distributed by FISCHER pursuant to this Agreement, ETHICON and FISCHER shall consult in good faith concerning the nature thereof and the means of implementing the same. If ETHICON shall determine to pursue such Product change or corrective action, FISCHER shall cooperate in implementing the Product change or corrective action, including, where indicated, notifying customers and arranging with them for return of the affected Product. ETHICON shall reimburse FISCHER for its reasonable costs of effecting any such Product change or corrective action, except that FISCHER shall bear the costs of any such action which results from the actions or omissions of FISCHER. ETHICON shall have no liability to FISCHER for any claims based on lost profits or business injury resulting from any such corrective action. In each case of any such corrective action, the minimum volume target set forth in Section 4 below shall be equitably adjusted. The provisions of this Section shall survive the expiration, cancellation or termination of this Agreement.

        (i)     Quarterly Reports . Each party shall keep the other advised of general market and other developments that may affect the sale of Products in the Field, as well as information on competitive products and activities which come to its attention. In addition, FISCHER shall provide ETHICON with a written quarterly report on a region by region basis describing its sales

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and marketing activities for the preceding quarter and providing a forecast and summary of marketing and promotional activities scheduled for the next quarter.

        4.      QUANTITIES, PRICES AND FORECASTS .

        (a)    Pricing . Transfer pricing and product availability schedules for the Products are described in Schedule 4(a) attached hereto. FISCHER agrees ETHICON may at any time change the transfer price upon 30 days prior written notice to FISCHER provided FISCHER receives the lowest transfer price paid by any other distributor or similar intermediary.

        (b)    Minimum Purchases . FISCHER agrees to place Purchase Orders (as defined below) for the volume of Products set forth in Schedule 4(b) hereto (the "Minimum Volume") during each calendar year of the term of this Agreement (each such period a "Contract Year"). If FISCHER fails to place Purchase Orders with ETHICON for the Minimum Volume, then the sole remedy of ETHICON is the option (which option must be notified in writing to FISCHER) to increase the transfer pricing in Schedule 4(a); provided, however, the transfer pricing shall not be increased if FISCHER pays an amount to ETHICON equal to the difference between the cost of the orders it placed during such year and the Minimum Volume.

        (c)    Limitation on Obligation to Supply . ETHICON's obligation to supply each of the Products hereunder shall at all times be subject to the condition that ETHICON is able to obtain or make a sufficient supply of such Product to sell to FISCHER. ETHICON shall use reasonable commercial efforts to meet delivery schedules. In the event that any Product available to ETHICON is in short supply, ETHICON shall notify FISCHER of such shortage and shall reasonably allocate to FISCHER a share of the amount of such Product available to ETHICON, taking into consideration the respective unit sales of FISCHER and ETHICON's other customers in the world for the Product(s). In such event, FISCHER's minimum volume targets for Product purchases shall be equitably adjusted.

        (d)    Estimated Quantities . In order to assist ETHICON in its production planning, FISCHER shall submit to ETHICON as soon as possible after the effective date of this Agreement a Product-specific Forecast of its expected requirements for Products in the First Contract Year. Thereafter, on a quarterly basis, FISCHER shall submit to ETHICON a rolling, non-binding written Forecast of FISCHER's expected requirements for Products for the following 12 month period 15 days prior to the next quarter (the "Forecast").

        (e)    Purchase Orders . FISCHER shall submit to ETHICON a purchase order on such form as the parties shall agree from time to time for its requirements of a specific Product(s) (a Purchase Order), and ETHICON shall supply FISCHER with the quantity so ordered.

        (f)     Terms of Sale . Subject to the provisions of Section 4(c) above, all Purchase Orders for Product shall be subject to reasonable acceptance by ETHICON, and all sales shall be subject to the terms and conditions of sale of the standard purchase order of ETHICON and notified to FISCHER in writing at the time of shipment. However, in the event such terms conflict with the terms and conditions established in this Agreement, this Agreement shall prevail. No provision on FISCHER's purchase order forms which may impose different conditions upon ETHICON or any Affiliate shall be of any force or effect unless expressly agreed to in writing by ETHICON.

        (g)    Payment . Terms for payment by FISCHER for Products ordered hereunder shall be net 30 days, from the later of the date of invoice or shipment on all purchases.

        (h)    Reporting . FISCHER shall provide ETHICON with quarterly sales reports for the Products in a format approved by ETHICON from time to time. Such reports will be provided to ETHICON on or before 30 days after the end of each quarter during the term of this Agreement.

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        (i)     Audit . ETHICON shall have the right during regular business hours to (i) inspect FISCHER's distribution facilities on reasonable advance notice of 30 days, (ii) review and audit FISCHER's books, records, inventories and activities in connection with its obligations under this Agreement on reasonable advance notice of 30 days, and (iii) ensure compliance with the FDA's regulatory requirements and ETHICON's own quality assurance guidelines applicable to the Products upon reasonable advance notice of 7 days.

        5.      DELIVERIES .

        In respect of Product order(s) that are up to 125% of the amount specified for a particular Product in the Forecast (as updated for the relevant month), ETHICON's standard lead time for delivery will be 30 days. In respect of that portion of any Purchase Order which is for greater than 125% of the amount of Product specified in the Forecast, ETHICON's standard lead time for delivery will be 60 days. In the event Products are not available in the standard lead times, ETHICON will notify FISCHER within 5 business days of receipt of an order of the expected shipment date. ETHICON will deliver orders of FISCHER, freight prepaid, FOB FISCHER's distribution facility specified in the Purchase


 
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