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AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT

Distribution Agreement

AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT 

     
 | Document Parties: VOLCANO CORP | FUKUDA DENSHI CO., LTD | VOLCANO JAPAN CO., LTD You are currently viewing:
This Distribution Agreement involves

VOLCANO CORP | FUKUDA DENSHI CO., LTD | VOLCANO JAPAN CO., LTD

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Title: AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT
Date: 3/24/2006
Industry: Medical Equipment and Supplies     Sector: Healthcare

AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT 

     
, Parties: volcano corp , fukuda denshi co.  ltd , volcano japan co.  ltd
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Exhibit 10.29

[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL INFORMATION HAS BEEN OMITTED. CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE CONFIDENTIAL PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]

FUKUDA DENSHI CO., LTD. AND VOLCANO CORPORATION AND VOLCANO JAPAN CO., LTD

AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT

     THIS AGREEMENT (“Agreement”), dated as of March 17, 2006 and which shall be effective on the Effective Date (defined below), is made and entered into among Volcano Corporation, a Delaware corporation, with its principal office at 2870 Kilgore Road, Rancho Cordova, California 95670, U.S.A. (hereinafter referred to as “Volcano USA”), Volcano Japan Co., LTD, a corporation of Japan and a wholly-owned subsidiary of Volcano USA, with its principal office at Ebisu Shimizu Bldg 4F, 1-25-7, Ebisu, Shibuya-ku, Tokyo (hereinafter referred to as “Volcano Japan”)(hereinafter Volcano USA and Volcano Japan are sometimes collectively referred to as “Volcano”) and Fukuda Denshi Co., Ltd. a corporation of Japan, with its principal office at 3-39-4 Hongo, Bunkyo-ku, Tokyo 113-8483, Japan (hereinafter referred to as “Fukuda”), and amends and restates certain Japanese Distribution Agreement, dated as of November 30, 2004, by and between Volcano and Fukuda (the “Original Distribution Agreement”).

     In consideration of the mutual promises contained herein, and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties agree as follows:

1. DEFINITIONS

     A. “Act” shall mean any act, statute, or regulation of any kind governing the products in the U.S.A. including the Federal Food, Drug and Cosmetic Act (21 U.S.C. Sections 301-392 (2002)).

     B. “Best Efforts” shall mean every necessary and prudent effort of a party applied in a prompt, commercially reasonable manner, to the maximum extent reasonably allowed by such party’s available financial resources, taking into account all of such party’s business commitments for such financial resources.

     C. “Effective Date” shall mean the date on which ownership of the Shonins shall have transferred from Fukuda to Volcano Japan.

     D. “EndoSonics Agreement” shall mean the Japanese Distribution Agreement, dated August 31, 1998, by and between Fukuda and EndoSonics Corporation, a Delaware corporation (“EndoSonics”), which was subsequently assigned to Volcano USA from Jomed, Inc., a Delaware corporation (formerly EndoSonics), that granted distribution rights related to certain medical device products to Fukuda from EndoSonics.

     E. “Exclusive Field” shall mean the cardiology field and does not include endovascular or peripheral applications fields.

     F. “Field” shall mean the Exclusive Field and the Non-Exclusive Field.

     G. “Fukuda Accounts” shall mean those accounts listed on Exhibit A.

     H. “Gray Accounts” shall mean those accounts listed on Exhibit C .

     I. “MOHLW” shall mean the Ministry of Health, Labour and Welfare for the country of Japan.

 


 

     J. “Non-Exclusive Field” shall mean the endovascular field.

     K. “QSR’s” shall mean the good manufacturing practices for medical devices set forth by any Act governing the products in the U.S.A. including United States 21 C.F.R. Section 820 (2004).

     L. “s5i consoles” shall mean a set of individual IVUS imaging system components (CPU, control stations, monitors, etc.) which are installed directly into the cath lab on a permanent (non-mobile) basis or built into mobile angiographic, ultrasound or other imaging types of equipment. For the avoidance of doubt, the s5i shall include IVUS systems integrated into the cath lab that have a control room, a cath lab, and or a bedside control panel of any number of form factors that is or is not linked to operation of the basic functions of the cath lab system and gantry.

     M. “Shonins” shall mean the regulatory approvals that are associated with the Volcano Products and that have been issued by the MOHLW.

     N. “Territory” shall mean the country of Japan, but as defined by the accounts listed in Exhibit A and Exhibit C. Fukuda shall make best effort and accept its responsibility to sell to Fukuda Accounts listed in Exhibit A . From time to time, and no less than annually, beginning January 1, 2007, the parties agree to review and modify Exhibit A and Exhibit C. Any Fukuda Account listed on Exhibit A to which no sales of any Volcano products have been made by Fukuda over a period of the prior twelve (12) consecutive months shall be deleted from Exhibit A and shall be added to Exhibit C and thereafter be considered a Gray Account.

     O. “Volcano Products” shall mean those products listed on Exhibit B attached hereto and all successor products thereto. Volcano Products may be changed, abandoned or added by Volcano, at its sole discretion, provided that Volcano gives one hundred twenty (120) days’ prior written notice to Fukuda.

2. APPOINTMENT AND AUTHORITY OF FUKUDA

     A.  Appointment . Subject to the terms and conditions set forth herein, for the period commencing on the Effective Date until June 30, 2012, Volcano hereby appoints Fukuda as:

          (i) Volcano’s exclusive distributor for Volcano Products, other than the s5i consoles, to Fukuda Accounts within the Exclusive Field within the Territory; and

          (ii) Volcano’s non-exclusive distributor for:

               a. the s5i consoles to Fukuda Accounts and Gray Accounts within the Field within the Territory;

               b. Volcano Products, other than the s5i consoles, to Fukuda accounts within the Non-Exclusive Field within the Territory; and

               c. Volcano Products, other than the s5i consoles, within the Field but limited to the Gray Accounts.

     Subject to the terms and conditions set forth herein, Fukuda hereby accepts such appointment.

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     B.  Use of Trademarks . Volcano hereby grants to Fukuda a non-exclusive license to use the Volcano Trademarks (defined herein below) for the purpose of identifying and marketing the products in Japan for use in the Field. Any use of the Volcano Trademarks will be in accordance with such instructions as Volcano may give Fukuda from time to time. Volcano shall, at its expense, use reasonable efforts to protect and maintain all registration, filings and issuance of Volcano Trademarks in full force and effect.

     C.  Fukuda Trademarks . Volcano shall not, without the prior written consent of Fukuda in each instance, use in any manner whatsoever, Fukuda’s name, its trademarks, logos, symbols or other images of Fukuda or of any party affiliated therewith.

     D.  Territorial Limitation . Fukuda shall not, without the prior written consent of Volcano USA: (i) promote, advertise, sell, distribute the Volcano Products in any country outside Japan; (ii) cause, directly or indirectly, the importation of the Volcano Products into any country outside Japan; nor (iii) establish a repair or maintenance facility in any country outside Japan.

     E.  Conflict of Interest . Commencing on the date hereof, Fukuda shall use its Best Efforts in the promotion and sale of the Volcano Products and all other products to which it acquires distribution rights hereunder.

     F.  Independent Contractors . The relationship of Volcano and Fukuda established by this Agreement is that of independent contractors, and nothing contained in this Agreement shall be construed to (i) give either party the power to direct and control the day-to-day activities of the other or (ii) allow either party to create or assume any obligation on behalf of the other party for any purpose whatsoever. All financial obligations associated with each party’s business are the sole responsibility of such party. All sales and other agreements between Fukuda and its customers are Fukuda’s exclusive responsibility and shall have no effect on Volcano’s obligations under this Agreement. Volcano shall be solely responsible for, and shall indemnify and hold Fukuda free and harmless from, any and all claims, damages or lawsuits (including attorneys’ fees) arising out of the acts of Volcano, its employees or its agents. Fukuda shall be solely responsible for, and shall indemnify and hold Volcano free and harmless from, any and all claims, damages or lawsuits (including attorneys’ fees) arising out of the acts of Fukuda, its employees or its agents.

3. TERMS OF PURCHASE OF PRODUCTS BY FUKUDA

     A.  Terms and Conditions . All purchases of Volcano Products by Fukuda from Volcano Japan during the term of this Agreement shall be subject to the terms and conditions of this Agreement.

     B.  Prices . All purchase prices to Fukuda from Volcano Japan for each of the Volcano Products (“Purchase Price”) are as set forth on the attached Exhibit B , as such Purchase Prices shall be amended from time to time during the term of this Agreement by mutual agreement of the parties.

     The Purchase Prices may be revised from time to time through consultation between Volcano and Fukuda, taking into account the then prevailing market prices of the similar products; provided, however that the Purchase Prices in effect as of the Effective Date shall not be revised prior to December 31, 2007. Such revisions shall apply to all orders received after the effective date of revision. Price increases shall not affect unfulfilled purchase orders accepted by Volcano Japan prior to the effective date of the price increase.

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     C.  Taxes . The amounts payable by Fukuda under Section 3 shall be calculated at Purchase Price plus the consumption tax (if applicable) and exclusive of any other tax and government charges (including, without limitation, interest and penalties), if any, payable to the Japanese government. Nothing in this Section 3.C. shall be construed to mean that Fukuda is responsible for taxes and charges (including, without limitation, interest and penalties) to the federal or state government of the U.S.A. which are imposed on Volcano USA and to the Japanese government which are imposed on Volcano Japan.

     D.  Order and Acceptance . All orders for Volcano Products submitted by Fukuda shall be initiated by written purchase orders sent to Volcano Japan and requesting a delivery date during the term of this Agreement; provided, however, that an order may initially be placed orally or by facsimile if a confirmational written purchase order is received by Volcano Japan within ten (10) days after said oral or facsimile order. To facilitate Volcano USA’s production scheduling, Fukuda shall use reasonable commercial efforts to submit purchase orders to Volcano Japan at least sixty (60) days prior to the first day of the requested month of delivery. No order shall be binding upon Volcano until accepted by Volcano Japan in writing, and Volcano Japan shall have no liability to Fukuda with respect to purchase orders that are not accepted. Volcano Japan shall notify Fukuda of the acceptance or rejection of an order and of the assigned delivery date for accepted orders within ten (10) days of receipt of the purchase order, if not rejected within such period of ten (10) days, the order shall be deemed accepted. Volcano will use its Best Efforts, consistent with its obligations to other similarly-situated customers, to process and ship all orders in accordance with requested delivery dates by Fukuda.

     E.  Terms of Purchase Orders . Fukuda’s purchase orders submitted to Volcano Japan from time to time with respect to Volcano Products to be purchased hereunder shall be governed by the terms of this Agreement, and nothing contained in any such purchase order shall in any way modify such terms of purchase or add any additional terms or conditions, unless in writing signed by Fukuda and Volcano Japan.

     F.  Payment . Volcano Japan shall submit an invoice to Fukuda upon each shipment of Volcano Products ordered by Fukuda. The invoice shall cover Fukuda’s Purchase Price for the Volcano Products in any given shipment plus [CONFIDENTIAL] of Fukuda’s Purchase Price for handling charge incurred by Volcano Japan. An amount equal to any freight, customs charges, charge for service of customs clearance agent, insurance fee and carriage or other applicable costs initially paid by Volcano but to be borne by Fukuda in Japanese Yen. Payment shall be made in U.S. dollars and payment shall be by wire transfer, check or other instrument approved by Volcano Japan. Payment terms shall be the full invoiced amount due for payment received by Volcano Japan within sixty (60) days of the date of the invoice. Any invoiced amount not received within sixty (60) days of the date of invoice shall be subject to a service charge of one and a half percent (1.5%) per month or such lesser percentage permitted by applicable law.

     G.  Shipping . All Volcano Products delivered pursuant to the terms of this Agreement shall be suitably packed for transportation from Volcano Japan to Fukuda in Volcano’s standard shipping cartons, marked for shipment at Fukuda’s address set forth above or any other address in Japan as Fukuda indicates (the “Fukuda Location”), and delivered by Volcano Japan, or Volcano Japan’s third-party designee, to Fukuda, at which time title to such Volcano Products and risk of loss shall pass to Fukuda. All transportation cost from Volcano Japan to Fukuda, insurance, and other applicable expenses, as well as any special packing expense, shall be paid by Fukuda.

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     H.  Rejection of Product . Fukuda shall inspect all Volcano Products, except those Volcano Products which are sterilized and sealed by Volcano at its plant, promptly upon receipt thereof and may reject any Volcano Product that fails to meet the specifications set forth in Volcano’s current product specifications for that Volcano Product. Any Volcano Product not properly rejected within sixty (60) days of receipt of that Volcano Product at Fukuda’s facility (the “Rejection Period”) shall be deemed accepted. To reject a Volcano Product, Fukuda shall, within the Rejection Period, notify Volcano Japan in writing by facsimile of its rejection and request a Return Material Authorization (“RMA”) number. Volcano Japan shall provide the RMA number in writing by facsimile to Fukuda within ten (10) days of receipt of the request. Within ten (10) days of receipt of the RMA number, Fukuda shall return to Volcano Japan the rejected Volcano Product, freight collect, in its original shipping carton with the number displayed on the outside of the carton. Provided that Volcano Japan has complied with its obligations in this Agreement, Volcano Japan reserves the right to refuse to accept any rejected Volcano Products that do not bear an RMA number on the outside of the carton. As promptly as possible but no later than fifteen (15) business days after receipt by Volcano Japan of properly rejected Volcano Products, Volcano Japan shall, at its expense, replace the Volcano Products and ship such replacement Volcano Products freight prepaid.

     I.  Return of Products After Rejection Period . After the Rejection Period, Volcano’s Standard Limited Warranty shall be applied. For sterilized and sealed Volcano Products such as catheters, however, Volcano shall replace those Volcano Products found defective with new Volcano Products if such defects should be found until the date the expiration of the shelf life of such Volcano Products to Fukuda if a notice with the details of such defects is given by Fukuda to Volcano Japan within a reasonable period after Fukuda or the user has discovered defects or ought to have discovered them. If Volcano tests and inspects these returned Volcano Products and determines that such Volcano Products perform according to Volcano’s written specifications, no credit will be given to Fukuda. If upon such test and inspections, such returned Volcano Products do not perform to Volcano’s written specification, these Volcano Products will be replaced at no cost to Fukuda except in the case that Volcano proves that such defect was caused after the shipment to Fukuda by Volcano Japan.

     J.  No Time Restriction . Notwithstanding any provision herein to the contrary, Fukuda’s rights and remedies under this Agreement or laws of Japan shall not be subject to any time restriction that may be imposed by any provisions of the laws of non-mandatory nature so long as Fukuda gives notice specifying the nature of the lack of conformity within a reasonable time after Fukuda or the user has discovered it or ought to have discovered it.

4. WARRANTY TO FUKUDA’S CUSTOMERS

     A.  Standard Limited Warranty . Fukuda shall pass on to its customers Volcano Standard Limited Warranty for the Volcano Products. This warranty shall cover the Volcano Products for a period of fifteen (15) months from the date of shipment to Fukuda. This warranty is contingent upon proper use of a Volcano Product in the application for which it was intended and does not cover Volcano Products that were modified without Volcano’s approval or that were subjected by the customer to unusual physical stress. If a Volcano Product fails to meet the warranty provided herein, Volcano’s sole liability and Fukuda and/or the end-user’s sole remedy shall be either the replacement by Volcano of the defective unit with another unit of the same product (or a unit of a substantially equivalent product thereto if the original model is no longer manufactured) or the refund by Volcano of the purchase price paid for such defective product.

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     B.  No Other Warranty . EXCEPT FOR THE EXPRESS WARRANTY SET FORTH ABOVE, VOLCANO HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, BY STATUTE OR OTHERWISE, REGARDING THE VOLCANO PRODUCTS, INCLUDING BUT NOT LIMITED TO THEIR FITNESS FOR A PARTICULAR PURPOSE, OR THEIR MERCHANTABILITY. OTHER THAN FOR PUNITIVE DAMAGES, NOTHING IN THIS SECTION 4 SHALL LIMIT THE INDEMNIFICATION OBLIGATION UNDER SECTION 8.A. WITH RESPECT TO DAMAGE CLAIMS FOR PERSONAL INJURY AND/OR DEATH CAUSED BY DEFECT OF THE VOLCANO PRODUCTS.

5. ADDITIONAL OBLIGATIONS OF VOLCANO AND FUKUDA

     A.  Clinical Trials: Management, Product Supply and Regulatory Approvals . Volcano agrees that it will undertake to manage, at Volcano Japan’s expense, all animal trials and human clinical trials required to obtain approval from all Japanese regulatory authorities to market in the Field throughout the Territory the Volcano Products and all other products under this Agreement. Volcano agrees


 
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