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HomeMy WebLinkAbout05-294 .doc SEPTEMBER 27, 2005 05-294 RESOLUTION (CARRIED 6-0 LOST LAID OVER WITHDRAWN PURPOSE: APPROVE AGREEMENT I ADVANCED CIRCULATORY SYSTEMS, INC. INITIATED BY: OSHKOSH FIRE DEPARTMENT BE IT RESOLVED by the Common Council of the City of Oshkosh that the Oshkosh Fire Department is hereby authorized to participate in the research trial titled Comparison of Standard Cardiopulmonary Resuscitation (S-CPR) alone versus Active Compression Decompression Cardiopulmonary Resuscitation (ACD-CPR) plus an Inspiratory Impedance Threshold Device (ITD) versus S-CPR plus an ITD on Survival From Out-of-Hospital Cardiac Arrest, otherwise known as the ResQTrial, which will involve the use of two devices, an Impedance Threshold Valve (ResQPOD) and Active Compression Decompression-CPR (ResQPump) for Improving Standard CPR. The proper City officials are hereby authorized to execute and deliver an appropriate agreement for purposes of the same, and said City officials are authorized and directed to take those steps necessary to implement the terms and conditions of the Agreement. CONFIDENTIAL CONSORTIDM AGREEMENT between Advanced Circulatory Systems, Inc. and Oshkosh Fire Department This Consortium Agreement ("Agreement") is entered into this 17th day of May, 2005, ("Effective Date") between Advanced Circulatory Systems, Inc., a Delaware for-profit corporation located at 7615 Golden Triangle Dr., Suite A, Eden Prairie, Minnesota (hereinafter referred to as "A CSI") and the Oshkosh Fire Department located at 1 0 1 Court Street, Oshkosh, WI, 54901 (hereafter referred to as "Subcontractor"). WHEREAS, the National Institutes of Health (NIH) has awarded to ACSI Grant No. 2-R44- HL65851-03 for a project entitled, "Impedance Threshold Valve for Improving Standard CPR" (hereinafter referred to as "Prime Award"), a copy of the grant award letter is attacbed hereto as Exhibit A and incorporated by reference herein; WHEREAS, ACSI has proposed a research collaboration with Subcontractor as incorporated and detailed in the application for the Prime Award ("Application"), a copy of which is attached hereto as Exhibit B and incorporated by reference herein; and WHEREAS, ACSI desires to have Subcontractor conduct work in conjunction with this research project; and WHEREAS, Subcontractor possesses the facilities and personnel necessary to pursue the objectives,. and fulfill the requirements of this subcontract; and NOW, THEREFORE, ACSI and Subcontractor hereto mutually agree to the following: ARTICLE I - Key Personnel The key personnel of Subcontractor cited below ("Key Personnel") shall serve the roles cited below for the project at that institution, and shall be responsible for all aspects of proposed work to be done there. Any change in Key Personnel shall be subject to the approval of ACSI. Michelle C. Peters, MD Steven J. Stroman, MD FACEP Co-Investigator Co-Investigator In addition to Key Personnel listed above, Tom Aufderheide, MD shall serve as Primary Investigator for the Subcontractor and Ron Pirrallo, MD will serve as Co-Investigator for the Subcontractor. Tom Aufderheide, MD and Ron Pirrallo, MD will have responsibility for all aspects of proposed work done by Key Personnel. ARTICLE n - Performance Period ResQ Tria! Version 1.0, 26MAY05 206813.2 Oshkosh Fire Department 1 CONFIDENTIAL The performance period of this Agreement shall begin on the Effective Date and shall not extend beyond January 1, 2008 unless amended by written mutual agreement of the parties to the Agreement. ARTICLE ill - Statement of Work Except as otherwise described in this Agreement, Subcontractor hereby undertakes and agrees to furnish all necessary personnel, services and facilities to perform satisfactorily the research services and achieve the objectives of the Prime Award Application and milestones defined in Exhibit D (collectively, "Services"). ARTICLE IV - Conflict of Interest and Confidential Information A. Subcontractor agrees that it is not presently under any agreement or obligation which conflicts with the duties and obligations owed to ACSI under this Agreement, the Prime Award and the Application, and further agrees not to undertake any such obligation or agreement for the duration of the Services. B. Subcontractor agrees as follows: 1. Anything in the Agreement to the contrary notwithstanding, any and all knowledge, know- how, practices, process, data, or other information (hereinafter referred to as "Confidential Information") disclosed or submitted verbally, in writing or in other tangible form to Subcontractor or to Key Personnel individually, or produced as a result of the Services, shall be received and maintained by the receiving party in strict confidence and not disclosed to any third party during the conduct of the Services and for seven (7) years thereafter. Furthermore, the Key Personnel and Subcontractor agree to use the Confidential Information only for the purpose of this Agreement. These parties may disclose Confidential Information to their employees or staff who require access thereto for the purposes of this Agreement provided, however, that prior to making any such disclosures, each such employee shall be bound by the same obligations as are the Key Personnel and Subcontractor to maintain Cotifidential Information in confidence and not to use such information for any purpose other than in accordance with the terms of this Agreement. 2. The terms of this Agreement, including but not limited to the financial terms, also shall be considered Confidential Information and shall be maintained in confidence by the parties in accordance with Article IV(B)(l) above. If, however, Key Personnel or Subcontractor is required by law or government regulation to disclose such information, they/it may do so without breaching their/its obligation under this Article, provided, in advance of disclosure that they use best efforts to notify in advance ACSI of the information to be disclosed, the reason for disclosure, and the date of disclosure. 3. Nothing contained herein will in any way restrict or impair any party's right to use, disclose, or otherwise deal with any Confidential Information which at the time of its receipt: ResQ Tria! Version 1.0, 26MAYO5 206813.2 Oshkosh Fire Department 2 CONFIDENTIAL a. is generally available in the public domain, or becomes available to the public through no act of the party receiving said Confidential Information; or b. is independently known by the party receiving the Confidential Information prior to receipt thereof, which said party can demonstrate by documented proof; or c. is lawfully given to the receiving party by a third party who received it in a lawful manner and who is not bound by any obligation to preserve it as confidential. ARTICLE V - Oversight and Monitoring ACSI shall provide direction and oversight of all aspects of the Services. ACSI's principal investigator and his designated personnel shall provide final approvals for the conduct of all aspects of the Services and related payments. ARTICLE VI - Payment A. As full compensation for the Services to be performed by Subcontractor and for all rights granted to ACSI by this Agreement, ACSI shall reimburse Subcontractor up to the total amount of$77,289, including direct costs of$77,289 and indirect costs of$O. This amount includes the direct costs of $44,485 and indirect cost of $0 for the period from February 1, 2006 through January 31,2008, which is beyond the initial Prime Award budget period of February 1,2005 through January 31, 2006. These future amounts are contingent upon the availability of funds from the NIH and satisfactory progress of the project as described in the Prime Awards terms and conditions. B. Certified and correct invoices showing categorical breakout of costs incurred shall be submitted not more frequently than monthly but at least quarterly, to ACSI by Subcontractor. Invoices shall be submitted to: Advanced Circulatory Systems, Inc. Attn: Accounts Payable 7615 Golden Triangle Dr., Suite A Eden Prairie, MN 55344 Payment shall be made for actual costs incurred by Subcontractor under the terms of the Agreement not to exceed the budgeted amounts listed in Exhibit C. C. A final invoice, covering costs through the end date of the Prime Award or any authorized extension ("End Date") shall be submitted to ACSI within 60 days of the End Date. Final invoices must be marked Final. D. Subcontractor shall maintain acceptable financial management systems during the term of this Agreement and shall arrange for the conduct of audits as required by OMB Circular A-:133. Subcontractor further agrees to provide ACSI with copies of any independent auditors' reports within thirty (30) days of completion of the audit, forwarding same to: ResQ Trial Version 1.0, 26MA Y05 206813.2 Oshkosh Fire Department 3 CONFIDENTIAL Advanced Circulatory Systems, Inc. Chief Financial Officer 7615 Golden Triangle Dr., Suite A Eden Prairie, MN 55344 In cases where non-compliance is noted, Subcontractor shall provide copies of responses to auditors' reports and a plan for corrective action. All pertinent books, documents, records and reports shall be made reasonably available for inspection by representatives of ACSI, NIH and the Government. ARTICLE vn - Allowable Costs and Budget A. By acceptance of this agreement, Subcontractor acknowledges that the total costs for the Services shall not exceed the budgeted costs as provided in Exhibit C, unless authorized in writing by ACSI and that all costs for Services shall be allowable by the terms of this Agreement, the terms of the Prime Award provided in Exhibit A, the terms of the National Institutes of Health Grants Policy Statement, dated December 2003 (NIHGPS), the procurement standards prescribed by 45 CFR 74 and the applicable Federal OMB Cost Principals, including OMB Circular A-122. B. Reimbursement for indirect costs shall be at the rate indicated in the budget provided in Exhibit C and shall not exceed Subcontractor's most recent Department of Health and Human Services (DHHS) Negotiated Agreement. C. Funds in the approved budget provided in Exhibit C may be rebudgeted in accordance with the policies contained in the NIHGPS, which sets forth requirements for the prior approvals. Rebudget requests and other requests requiring NIH prior approval shall be submitted to ACSI for ACSI's prior approval. D. Subcontractor shall inform ACSI of any program-related income generated under this Agreement and shall maintain appropriate records of the receipts and disposition of such income to enable ACSI to fulfill its reporting responsibilities. Disposition of such income will be dictated by the terms of the NIHGPS. ARTICLE vm - Records and Audit Financial records, supporting documents and other records pertinent to this Agreement shall be retained by Subcontractor for a period of three (3) years from the date of submission of all closing documents. Records pertaining to audits, appeals, litigation or settlement of claims arising out of performance of this Agreement shall be retained until such audits, appeals, litigation or claims have been resolved and fmal action taken. ACSI, the NIH and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the right of timely and unrestricted access to any books, documents, papers and other records of Subcontractor, which are pertinent to the Prime A ward, for the purpose of making audits, examinations, excerpts, transcripts and copies. ARTICLE IX - Reports ResQ Trial Version 1.0, 26MAY05 206813.2 Oshkosh Fire Department 4 CONFIDENTIAL Reports shall be submitted in a timely fashion by Subcontractor to ACSI at the request of the Prime Award's principal investigator, as is necessary in order to be included in the annual and fmal reports to NIH and any other reports that may be required as a result of the Prime Award. ARTICLE X - Assurances Subcontractor, by signing this Agreement, certifies compliance with the following and that appropriate assurances are on file with DHHS: A. Human Subjects, Derived Materials or Data - Subcontractor agrees to abide by DHHS regulations concerning Human Subjects, DHHS regulation, 45 CFR Part 46 as amended, and institutional assurances, including the implementation of procedures for review, and the assignment of responsibilities for adequately protecting the rights and welfare of human subjects. Safeguarding these rights and welfare is, by DHHS policy, primarily the responsibility of the subcontracting organizations. In particular, Subcontractor is responsible for ensuring that the activity described or covered by this Agreement, and additional information relating to human subjects, derived materials or data are reviewed and approved by an institutional review board. Subcontractor agrees to maintain their FW A throughout the project period as required by federal regulation. B. Debarred or Suspended Parties - Subcontractor certifies, in accordance with Executive Orders 12549 and 12689 and 45 CFR Part 76, Debarment and Suspension, that neither it nor its principals nor its research personnel are presently debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from covered transactions by any federal department. or agency. Any participants that are lower tier participants of Subcontractor under this Agreement must make the same certification to ACSI, via Subcontractor, concerning their covered transactions. C. Delinquent Federal Debt - Subcontractor certifies, in accordance with OMB Circular No. A- 129 as amended, that it is not delinquent on the repayment of any federal debt. D. Misconduct in Science - Subcontractor certifies, in accordance with 42 CFR Part 50, that an acceptable assurance for dealing with and reporting possible misconduct in science is on file with the Food and Drug Administration. E. Certification Regarding Lobbying - Subcontractor certifies thatto the best of their knowledge, they are in compliance with 31 USC 1352, "Limitation on use of Appropriated funds to influence certain Federal contracting and financial transaction," for subcontracts for $100,000 or more. F. Conflict oflnterest - Subcontractor certifies that it has established a written, enforced policy on conflict of interest that complies with requirements of the NIHGPS. G. Confidentiality - Subcontractor shall comply with NIH policy detailed in the NIHGPS that requires appropriate action be taken to protect the confidentiality of information about and the ResQ Trial Version 1.0, 26MA Y05 206813.2 Oshkosh Fire Department 5 CONFIDENTIAL privacy of individuals participating in the research H. Student Unrest - Subcontractor shall be responsible for carrying out the provisions of any applicable statutes, including section 407 of the HHS Appropriations Act, relating to remuneration from funds provided by this Agreement to any individual who has been engaged or involved in activities described as "student unrest." 1. Non -Discrimination - Subcontractor certifies it has filed with the DHHS Office for Civil Rights: an Assurance of Compliance (Form HHS 690) with Title VI of the Civil Rights Act of 1964 (P.L. 88-352, as amended), which prohibits discrimination on the basis of race, color, or national origin; Section 504 of the Rehabilitation Act of1973 (P.L.93-112, as amended), which prohibits discrimination on the basis of handicaps; Title IX of the Education Amendments of 1972 (p.L. 92-318, as amended), which prohibits discrimination of the basis of sex; and the Age Discrimination Act of 1975 (P.L. 94-135), which prohibits discrimination on the basis of age. J. Clean Air Act - Subcontractor shall comply with all applicable standards, orders or regulations issued pursuant to the Clean Air Act, 42 D.S.C. 7401 et seq., and the Federal Water Pollution Control Act as amended, 33 D.S.C. 1251 et seq. Violations shall be reported to the NIH and the Regional Office of the Environmental Protection Agency. ARTICLE XI - Equipment Accountability and Disposition Subcontractor shall have the responsibility for the purchases, inventory, accountability, and disposition of equipment that it purchases for the objectives of the contract. This equipment should be purchased in accordance with the contract provisions and subject to Public Law 95-224 and the regulations as stated in 45 CFR part 74. ARTICLE XU - Publications A. ACSI and Subcontractor retain the right to freely publish and disseminate the results of the investigation related to this Agreement. Published results shall include manuscripts for publication in scientific/academic journals, abstracts of scientific/academic papers, scientific/academic poster presentations and similar material generated as a result of this Agreement for use in the academic/scientific community, collectively referred to hereinafter as "Publication( s)". To protect patent rights and ACSI' s Confidential Information, Pub lication( s) shall be submitted to ACSI for review and comment. B. ACSI shall advise the publishing party within sixty (60) days of receiving any Publication(s) of: 1. any disclosure of information that will result in a loss of patent rights (hereinafter referred to as "Patentable Material"), and 2. any disclosure of ACSI Confidential Information. C. If ACSI informs the publishing party that it is desirable to file patent applications on Patentable Material disclosed in the Publication(s), the publishing party may, at its option,: 1. delete the Patentable Material and publish or disclose the Publication(s); or ResQ Trial Oshkosh Fire Department Version 1.0, 26MAY05 6 206813.2 CONFIDENTIAL 2. postpone publication or disclosure for not more than ninety (90) days beyond the date on which the Publication(s) was provided to provide time for the Subcontractor or ACSI to file patent applications in accordance with Section XIV. D. Upon mutual agreement that the Publication(s) contains ACSI Confidential Information, the publishing party shall delete the information. Notwithstanding the foregoing, results of the study and data used to support the results are not Confidential Information when published by Subcontractor. . E. Publication(s) by either of the parties to this Agreement shall give proper credit to the other party for the cooperative character of the investigation. No commercial brands or trade names shall appear in the publication of the results except as such brand or trade names are essential in the description of the research, nor shall the name of the ACSI or Subcontractor be used in any way for advertising purposes without that party's prior written consent. Any publication by Subcontractor resulting from the Services under this Agreement shall include an acknowledgment disclaimer, as appropriate, such as: "This (publication, journal, article, etc.) was supported by the National Institutes of Health under Grant No. 2-R44-HL65851-03. Its contents are solely the responsibility of the Authors and do not necessarily represent the official views of the National Institutes of Health or Advanced Circulatory Systems, Inc." Publication of project results shall be in conformance with NIHGPS guidelines. F. Prior to pub lication by either party to this Agreement, no publicity shall be given by either party to any of the results of the investigation, except with prior approval in writing by a duly- authorized representative ofthe other party. Notwithstanding the foregoing, ACSI may use the results of research study conducted in accordance with the Prime Award ("Study") and the supporting data prior to the release of any Publications in activities and materials that support the commercialization of the technology and/or products used in the Study, so long as the activities and materials are not Publications. G. No party hereto shall originate any publicity, news release, advertising promotion or commercial material, or other public announcement, written or verbal, whether to the public press or otherwise, relating to this Agreement, the Study protocol ("Protocol"), the Study conducted hereunder, or to any amendment(s) without the other party's prior express written consent, except as required by law and except as described in Section F above. ARTICLE xm - Rights in Data and Copyright A. The term "Subject Data" as used herein includes research data and reports, writing, sound recordings, pictorial reproduction, drawings or other graphical representations, and works of any similar nature (whether or not copyrighted) which are specified to be delivered under this subcontract. The term does not include fmancial reports, cost analyses and similar information incidental to contract administration. B. Ownership of all copyrights arising from the Subject Data shall be vested in the Subcontractor, subject to the provisions of 37, CFR, 401. If Subcontractor does not wish to obtain such ResQ Trial Version 1.0, 26MAY05 206813.2 Oshkosh Fire Department 7 CONFIDENTIAL copyrights, ACSI is then vested with said ownership rights and may secure such copyrights. ACSI retains a royalty-free, non-exclusive and irrevocable license to reproduce, publish, alter, or otherwise use and to authorize others to use Subject Data. Further, the Federal Government retains a royalty-free, non-exclusive and irrevocable license to reproduce, publish, alter, or otherwise use and to authorize others to use any such materials for government purposes. C. Nothing in the agreement shall be construed to limit the right of ACSl's employee to publish the Subject Data in scholarly or professional journals so long as'any copyright to be obtained is not prejudiced thereby. ARTICLE XIV - Subject Inventions A. The term "Subject Invention" as used herein includes any invention either conceived or first actually reduced to practice in the performance of work under the Prime Award. B. Ownership of all patents arising from Subject Inventions shall be vested in the Subcontractor, subject to the provisions of 37, CFR, 401. If Subcontractor does not wish to obtain such patents according to the provisions of 37, CFR, 401, ACSI is then vested with said ownership rights and may secure such patents. ACSI shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced any Subject Invention throughout the world. The Federal Government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for on or behalf of the United States any Subject Invention throughout the world. ARTICLE XV - Termination A. Either party may terminate this Agreement upon the delivery to the other party of a written notice thirty (30) days prior to termination. B. In the event the Prime Award is suspended. terminated or the funding thereunder ceases, ACSI may immediately suspend or terminate, in whole or in part, this Agreement, by sending written notice of same, to Subcontractor. C. Upon receipt of a notice of termination from ACSI, Subcontractor shall take all necessary action to cancel outstanding purchase orders and other commitments relating to the work under this Agreement, and shall exercise reasonable diligence to cancel or redirect commitments for personal services to its other activities and operations. D. Upon termination of this Agreement for any reason: 1. Subcontractor will prepare and submit to ACSI for its approval the reports for all Services rendered by ACSI through the effective date oftermination. 2. In the event of early termination, ACSI shall remain liable for all costs incurred under the Agreement in good faith prior to the receipt of the above-mentioned notices. Upon payment of such costs, ACSI shall be entitled, and Subcontractor agrees to deliver, all information and ResQ Trial Version 1.0, 26MAY05 206813.2 Oshkosh Fire Department 8 CONFIDENTIAL items which, if the Services had been completed, would have been required to be furnished to ACSI, including, but not limited to, partially completed plans, drawings, data, documents, surveys, maps, reports and models. 3. The parties' respective warranties, record keeping and indemnity obligations hereunder shall survive termination of this Agreement. ARTICLE XVI - Jurisdiction Each party to this Agreement agrees to comply with all applicable laws and regulations relating to performance of their respective responsibilities under this Agreement including but not limited to laws and regulations administered by the U.S. Food and Drug Administration. This agreement shall be construed under, and the rights and obligations of the parties shall be determined by and in accordance with, the laws of Minnesota. ARTICLE xvn - Indemnification A. ACSI agrees to indemnify, defend and hold harmless the Key Personnel and Subcontractor from and against any loss, damage, and/or expense (including reasonable attorney's fees) that they may suffer as a result of claims, demands, costs or judgments ("Claims") which may be made or instituted against them by a third party by reason of personal injury (including death) to any Study subject, which injury arises out of or is otherwise sustained as the result of participation in the Study and/or the result of the use ofthe ACSI's impedance threshold valve and active compression decompression pump when performing CPR _pursuant to the Protocol designáted in the Study; provided, however, that ACSI's indemnification obligations hereunder shall not apply to the extent that any Claim relates to: 1. A failure by the Key Personnel (or any other research personnel involved in the performance of the Study) to adhere to the terms of the Protocol; 2. A failure to comply with any applicable FDA or governmental requirements, or; 3. The negligence or wrongful act or omission or willful malfeasance by the Key Personnel, their trustees, officers, agents and employees. Subcontractor shall notify ACSI of any such claim, cause of action or suit made against it. Such notice shall be given to ACSI within 30 days of the date on which Subcontractor first becomes aware of the claim, cause of action or suit. ACSI may assume full control over the defense or settlement of any such claim, cause of action, suit or proceeding and Subcontractor will cooperate with all reasonable requests of ACSI in that regard. B. Subcontractor shall indemnify, defend and hold ACSI harmless from and against all claims, causes of action, suits, damages and costs arising out of, resulting from, or otherwise in respect of the negligence or intentional misconduct of Subcontractor, Key Personnel, or any of Subcontractor' s trustees, officers, agents or employees, and/or for the result of the failure of Subcontractor, Key Personnel, or any of Subcontractor's trustees, officers, agents or ResQ Trial Version 1.0, 26MA Y05 206813.2 Oshkosh Fire Department 9 CONFIDENTIAL employees to (i) comply with an applicable FDA or other governmental requirements or (ii) adhere to the terms of the Protocol. ACSI shall notify Subcontractor of any such claim, cause of action or suit made against it. Such notice shall be given to Subcontractor within 30 days of the date on which ACSI fIrst becomes aware of the claim, cause of action or suit. C. ACSI shall, at its sole cost and expense, procure and maintain in force during the term of the Study a general liability insurance policy or policies, including products liability, in an amount not less than $1,000,000 per incident and $1,000,000 annual aggregate. Such insurance shall be maintained for a reasonable period of time, which in no event shall be fewer than three (3) years after completion of the Study. ACSI agrees to furnish Subcontractor with written notice thirty (30) days prior to any decrease in coverage below the minimum requirement. D. Subcontractor shall, at its sole cost and expense, procure and maintain in force during the term of the Study a general liability insurance policy or policies, including products liability, in an amount not less than $1,000,000 per incident and $1,000,000 annual aggregate. Such insurance shall be maintained for a reasonable period of time, which in no event shall be fewer than three (3) years after completion of the Study. Subcontractor agrees to furnish ACSI with written notice thirty (30) days prior to any decrease in coverage below the minimum requirement. ARTICLE XVIII - Independent Contractor The Key Personnel's and Subcontractor's relationship to ACSI under this Agreement is that of independent contractors and nothing contained herein shall be interpreted as creating any other relationship. Neither any Key Personnel nor Subcontractor is authorized or empowered to act as agent for any other party for purposes related to the Study or otherwise and shall not on behalf of any other party enterinto any contract, warranty, or representation as to any matter for the duration of the Study. ARTICLE XIX - Waiver The waiver by either party of any breach, tenD, provision or condition of this Agreement shall not be deemed or construed as a further or continuing waiver of any such breach, term, provision or condition or a waiver of any other or subsequent breach, term, provision, or condition contained in this Agreement. ARTICLE XX - Miscellaneous A. The parties agree that the obligations contained in Articles IV - Conflict of Interest and Confidential Information, XII-Publications, XIII - Rights in Data and Copyright, XIV - Subject Inventions, XVI - Jurisdiction and XVII. Indemnification shall survive the termination of this Agreement. B. If any provision of this Agreement is held invalid or unenforceable, the remainder of the Agreement shall not be affected thereby. . ResQ Trial Version 1.0, 26MA Y05 206813.2 Oshkosh Fire Department 10 CONFIDENTIAL ARTICLE XXI - Notices A. Notices, invoices, communications, and payments required or permitted hereunder shall be considered made and effective when deposited in the U.S. mail, postage prepaid, and addressed to the appropriate party at the address noted below, unless by notice to the other parties a different address shall have been designated. If to Subcontractor: Oshkosh Fire Department (For all correspondence) 101 Court Street Oshkosh, WI 54904 City of Oshkosh (For Payments) Attn: Edward Nokes Director of Finance PO Box 1130 Oshkosh, WI 54903 If to Key Personnel: Michelle Peters, MD Steve Stroman, MD Oshkosh Fire Department 101 Court Street Oshkosh, WI 54904 If to ACSI: Advanced Circulatory Systems, Inc. 7615 Golden Triangle Drive, Suite A Eden Prairie, MN 55344 USA Attention: Chief Financial Officer ARTICLE xxn - Contract Complete This Agreement contains all Agreements and covenants between the Subcontractor and ACS1. All items incorporated by reference are to be attached. No other understandings, oral or otherwise, regarding the subject matter of this Agreement shall be deemed to exist to bind either of the parties hereto. . ARTICLE XXIll - ACSI Prior Approval Any prior approvals required by the terms of the Agreement shall be requested in writing by ResQ Trial Version 1.0, 26MAY05 206813.2 Oshkosh Fire Department 11 CONFIDENTIAL Subcontractor and shall be submitted to ACSI. Requests shall be considered approved upon signing by ACSI's principal investigator and an appropriate ACSI administrative official. ACSI will request NIH prior approval, when deemed necessary or required. ARTICLE XXIV - Assignment or Modification Any assignment or subcontract or change in scope or objective of the Services under this Agreement shall be valid only with ACSI' s prior approval. Any amendment or modification to this Agreement shall be valid only by written mutual agreement signed by the authorized representatives of the parties hereto. ARTICLE XXVI - Order of Precedence Any inconsistency in this Agreement shall be resolved by giving precedence in the following order: 1) Prime Award terms and conditions; 2) Agreement clauses; 3) other documents, exhibits, and attachments. ARTICLE XXVII - Expanded Authorities This Agreement is included under Expanded Authorities. Regardless of inclusion in the NIH Expanded Authorities, Subcontractor shall not extend the period of this Agreement nor carryover unobligated balances without ACSI's prior approval. In witness whereof, the parties hereto, represented by officials authorized to bind them, have caused this Agreement to be executed in duplicate as of the date(s) set forth below. Advanced Circulatory Systems, Inc. By: Michael R. Black Title: Chief Financial Officer Signature Date Oshkosh Fire Department By: Timothy Franz Title: Chief of Operations Signature Date ResQ Tria! Version 1.0, 26MA Y05 206813.2 Oshkosh Fire Department 12 CONFIDENTIÀL INVESTIGATOR STATEMENT I have agreed to act as one of the Key Personnel for the Study. I have read the terms and conditions ofthis Agreement, understand my obligations contained herein, and agree to abide by them and my - responsibilities as an Investigator for a Significant Risk Device Investigation as detailed in 21 CFR 812 in all respects. Printed name: Michelle Peters, MD Signature Date Printed name: Steven Stroman, MD, F ACEP Signature Date ResQ Trial Version 1.0, 26MAY05 206813.2 Oshkosh Fire Department 13