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Fire Dept AED Contract ROC 5UB~E ~~~ MEMORANDUM (; March 15, 2006 TO: The Honorable Mayor and City Council Members ""j FROM: Michael C. Van Milligen, City Manager SUBJECT: AED Contract for Resuscitation Outcomes Consortium (ROC) The Fire Department is participating in a National Institute of Health Resuscitation Outcomes Consortium (ROC). loll Corporation, in cooperation with the ROC, is offering to provide Automatic External Defibrillators (AED) Pro monitor defibrillators to Dubuque Fire for the five year ROC study at no cost. The AEDs will remain the property of loll and a one year warranty will apply. These AEDs cost approximately $3,500, and at the end of the five year study, Dubuque Fire has an option to purchase the units for $700, and will include an additional one year warranty. Fire Chief Dan Brown is recommending City Council approval of the agreement with loll Corporation for Equipment Loan for Resuscitation Outcomes Consortium. I concur with the recommendation and respectfully request Mayor and City Council approval. \Jill. Jd "'I~ i i . . 6 'I, . ..' '------ . Michael C. Van Milligen MCVM/jh Attachment cc: Barry Lindahl, Corporation Counsel Cindy Steinhauser, Assistant City Manager E. Daniel Brown, Fire Chief March 1, 2006 TO: Michael C. Van Milligen, City Manager FROM: E. Daniel Brown, Fire Chief SUBJECT: AED Contract for Resuscitation Outcomes Consortium (ROC) The Fire Department is participating in a National Institute of Health Resuscitation Outcomes Consortium (ROC). In order for the data that the ROC study needs changes have to be made to some of the equipment that we currently use on the ambulance and on the fire units. The department's cardiac monitor/defibrillator will require software upgrades and the Automatic External Defibrillators (AED) will need to be changed in order to record data needed for the study. For "M" series on our ambulances, loll will provide software upgrades at no cost. loll will provide other consumables like batteries and CPR-D Padz at a reduced cost (50%). loll will also provide software for station computers at no cost. Delivery or shipping cost is at our expense. loll Corporation in cooperation with the ROC is offering to provide AED Pro monitor defibrillators to Dubuque Fire for the 5 year ROC study at no cost. The AED will remain the property of loll. A 1 year warranty will apply. These AED's are approximately $3,500; at the end of the 5 year study Dubuque Fire has an option to purchase for $700 and will include an additional 1 year warranty. There is also an extension option if the study goes on an additional 5 years. At the termination of the ROC study the AED's will be shipped back to loll if the department chooses not to purchase. At the end of the 5 year study the department would evaluate the option to purchase or move in a different direction. This agreement will provide 14 AED Pro's to equip all of our front line Fire Department vehicles. The department currently has 10 AED's that are in good operating order and can be used elsewhere in the city and I would recommend that we distribute them to the other departments that could utilize this equipment. We would expect delivery of this equipment within weeks of executing the agreement. Barry Lindahl has reviewed the contract and I am recommending this contract be submitted to Mayor and City Council for approval authorizing the City Manager to execute the agreement. Confidential Agreement, Equipment Loan for Resuscitation Outcomes Consortium AGREEMENT between DUBUQUE FIRE EMSE at 11 West 9th Street, Dubuque, Iowa, hereinafter called "ROC SITE" and ZOLL MEDICAL CORPORATION, a Massachusetts corporation, 269 Mill Rd., Chelmsford MA 01824, hereinafter called "ZOLL". Whereas ZOLL wishes to provide to ROC Site a five (5) year grant in support of the Resuscitation Outcomes Consortium ("ROC"), they agree to the following: 1. The Scope of Work. ZOLL will be providing equipment for the support of ROC, an NIH- funded study research grant #1 U01 HL77865. 2. Period. The period of performance will be from November 1, 2005 to October 31, 2010 ("Study Period"). 3. Investigator. The project will be under the supervision of Investigator name, Wayne Dow, EMS Supervisor (the "Investigator"). 4. AED Devices 4.1. The Offer ZOLL will provide up to 14 AED Pro monitor-defibrillators ("ROC AEDs") along with a (0.1 x 14) units for use as spare units on loan to the ROC SITE based on inventory numbers provided to the Clinical Trials Center by March 1,-2005. The ROC AEDs will remain the property of ZOLLo 4.2. Warranty One year Warranty will be provided. Service Contracts can be provided for the period after the expiration of the standard warranty, pricing to be based on total units acquired by all ten (10) ROC sites combined. Other Service will be billed at standard ZOLL rates and service. Shipment cost to be paid by ROC Site. 4.3. AED Damage Units rendered unserviceable due to damage, abuse or destruction will be billed at $1000.00 for replacement units. 5. M-Series Defibrillators ZOLL will provide software upgrades to make the M-Series capable of collecting CPR process data with the monitoring technology for analysis and interpretation after the conclusion of the resuscitation. Installation of the software shall be the responsibility of the ROC site personnel. 6. Accessories One (1) Battery Charger will be supplied per ten (10) AEDs. Additional chargers may be needed, depending on system configuration and will be provided at a ROC discount of 40% off list price (pin 8050-0002-01, $1000, with four bays and three batteries for lead acid cells only; pin 8050-0022-01, $300, with one bay and no batteries for lead acid only) 7. Consumables This agreement provides special consideration (50% discount) for consumables such as batteries, electrodes and data collection devices not including software. Memory cards for M-Series:ZOLL pin # USLF016MBZOLL, $90 CPR-D Padz per unit (four year shelf life): $75/pad Disposable Lithium primary battery pack (compatible with only the AED Pro): $50 Rechargeable Lead-Acid Battery pack (compatible with both AED Pro and M-Series): ZOLL pin 8000-0299-01, $65 8. Software All software for data collection will be provided at no cost, including all software upgrades to the ZOLL Data Code Review product. Installation of software on site computers is the responsibility of the site. These are the minimum hardware requirements: 1.3 GHz processor or higher, Windows XP, and at least 256MB RAM and 30GB hard drive, and Ethernet. No computer hardware is provided as part of this agreement Software installation and deployment support by phone will be provided Qualified information technology personnel must be provided by each site to provide any ongoing support required on site. 9. Shipping Equipment supplied with be FOB ZOLL, all freight and forwarding charges are the responsibility of the site and will be billed at normal commercial rates. 10. Delivery The equipment is expected to be available for phased delivery during the period December 2005 to May 2006, but for those sites which require a longer time for implementation ZOLL would be open to a mutually agreed upon deadline as late as June 30, 2006. 11. Purchase Option a) Purchase Option: At the conclusion of the study, ROC site may purchase the ROC AEDs from ZOLL at a price of $700.00 U.S. The device will include one additional year of warranty, excluding batteries and other consumables. b) Loan extension option: At the conclusion of the term of agreement, the ROC Site may elect to extend the term of the agreement for an additional 5 years, at their sole discretion. If that option is elected by ROC Site, accessory and consumable pricing as stated in clause 6 and 7 will revert to standard ZOLL Medical pricing; all other clauses will remain in effect. In the case that the ROC Site discontinue participation in ROC either voluntarily or involuntarily prior to the conclusion of the Study Period, clause 11 b loan extension option will not remain in effect. c) If the ROC site discontinues participation in the ROC either voluntarily or involuntarily and has participated in ROC for a period less than three years at the time of discontinuation of participation, then clause 11 a Purchase Option will not remain in effect and the AED Pro units must be returned to ZOLL as stipulated in clause 15. 12. Assignment The ROC AEDs cannot be assigned to any other agency or third party without ZOLL's expressed, written permission. 13. Equipment Coordinator ROC Site must designate and equipment coordinator, as the primary contact for ZOLL medical equipment and training issues: Wayne Dow, 11 West 9th Street, Dubuque, Iowa, Phone (563) 589-4194). 14. Product Orientation and In-service ZOLL personnel will provide a "train the trainer" session equivalent to one day's training time, for use of ZOLL equipment. ROC Site will be required to train all additional study participants in the use of ZOLL equipment. 15. Termination of the Study At the conclusion of the Study Period, if the purchase option has not been exercised as in clause 11, the ROC Site personnel will package ROC AEDs that are the property of lOll with shipping container that will be supplied by lOll and ship back to lOLL. 16. Equipment Location The location of all equipment will be disclosed to lOll in writing upon distribution and when any equipment is transferred from its original designation. 17. Best Agreement Provision ROC Site can utilize purchasing provisions of any current agreements with lOll that are more favorable that the terms of this Agreement. 18. Indemnification This indemnification shall be limited to any claim or legal cause of action which is due to a failure of such ROC AEDs provided by lOll. ZOll shall not be responsible for: a) any liability, damage, losses, or expense to the extent that it is directly attributable to: (i) the grossly negligent activities, reckless misconduct or intentional misconduct of the person(s) to be indemnified; b) any injury, illness, or death resulting from services that would have been delivered in the normal course of medical care absent this agreement lOll agrees to indemnify ROC Site, its officers, trustees, overseers, agents, and employees, and hold them harmless from any and all injury, illness, death, property damage, claim, lawsuit, judgment thereon, or cause of action which results either in whole or in part as a result of a failure of a ROC AED. 19. Regulatory lOll confirms that it has the necessary approvals of the US Food and Drug Administration (FDA) and Health Canada for the clinical use of technology to monitor performance of cardiopulmonary resuscitation. 20. Compliance with NHLBI Policies and Procedures This agreement shall be consistent with NHlBI Policies and Procedures for Third-Party Involvement in NHlBI-supported clinical trials. 21. Notices. All communications, reports, and notices required or permitted hereunder will be deemed sufficiently given if in writing and personally delivered or sent by registered mail, postage prepaid, return receipt requested, addressed to the parties as follows or at such other address as a party will have given notice of pursuant hereto: If to ROC Site: Dubuque Fire EMS Attn. Wayne Dow, EMS Supervisor 11 West 9th Street Dubuque, IA 52001 Phone: FAX: (563) 589-4194 (563) 589-0894 If to lOll: lOll Medical Corporation Attention: Gary A. Freeman, VP, Clinical Affairs 269 Mill Rd. Chelmsford, MA 01824 Telephone: Facsimiles: (800) 348-9011 (978)-421-0007 22. Laws and Regulations This Agreement will be governed by, and construed and enforced in accordance with, the laws of the State of Massachusetts. lOll will cooperate with ROC Site in complying with any applicable federal, state and local laws, regulations and policies governing research. 23. Entire Agreement. This Agreement, including all Exhibits referenced herein, will be the complete Agreement of the parties hereto and will supersede all prior agreements and understandings, oral or written, between the parties respecting the subject matter hereof. The respective parties have executed this Agreement on the dates indicated below. ZOll Medical Corporation ROC Site Official ZOll Official Michael Van Milligen Title Gary Freeman Title Dubuque City Manager Date Vice President of Clinical Affairs Date