Amendment No. 5 to Exclusive Distributor Agreement between Cambridge Heart and Fukuda Denshi (June 28, 2002)

Summary

This amendment extends the exclusive distributor agreement between Cambridge Heart and Fukuda Denshi through May 31, 2003. Fukuda Denshi must meet minimum purchase requirements for CH 2000 Systems and will have exclusive rights to market the HeartWave product in Japan, subject to certain purchase and regulatory approval conditions. Pricing for HeartWave units and sensor sets is specified, and provisions are included for transfer of regulatory approvals and reimbursement of related expenses if exclusivity is not continued. Both parties agree to discuss possible term extensions if regulatory approval is delayed.

EX-10.1 5 a2093334zex-10_1.txt EXHIBIT 10.1 Exhibit 10.1 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. AMENDMENT #5 OF EXCLUSIVE DISTRIBUTOR AGREEMENT OF MAY 30, 1996 Dated: June 28, 2002 1) Term: The term is hereby extended through May 31, 2003 2) CH 2000: a) Minimums: There shall be [**] minimum purchases required of CH 2000 Systems. 3) Heartwave: a) Exclusivity: FD will purchase [**] units of HeartWave for a period of trial marketing. Based upon this purchase FD will have exclusive rights to market HeartWave in Japan for the period ending May 31, 2003. b) MHLW Approvals: By signature of this Amendment #5, FD acknowledges that they have made appropriate filing with the MHLW in Japan. Anticipated MHLW approval is estimated by October 2002. c) Minimum purchases: Within 30 days of import approval by MHLW, FD agrees to issue CHI a purchase order for [**] HeartWave systems as per 3a. In any eventuality FD agrees to purchase the [**] Heartwave systems no later than December 16, 2002. d) Pricing: Pricing of the [**] units of the Heartwave as mentioned above in 3c will be $[**] per unit. e) Termination: In the event that FD and CHI are not able to agree on terms for continuation of FD's exclusive rights to market HeartWave for the period beyond May 31, 2003 then, if CHI requests, FD will transfer the MHLW import approval to a distributor of CHI's choosing. In such case CHI will pay FD's direct expenses for obtaining MHLW approval. f) If MHLW approval takes greater than 4 months from submission, and FD has submitted in accordance with 3b, both sides agree to discuss possibilities of extending the term for exclusivity. Page 1 11/13/02 4) Sensor Pricing: a) The price of sensor sets will remain at $[**] through May 31, 2003. CAMBRIDGE HEART FUKUDA DENSHI Signed: /s/ David A. Chazanovitz Signed: [ILLEGIBLE] ------------------------- ----------------------- By: David A. Chazanovitz By: ---------------------------- --------------------------- Date: June 28, 2002 Date: --------------------------- --------------------------- Page 2 11/13/02