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HomeMy WebLinkAboutContract 63585CSC No. 63585 CITY OF FORT WORTH ASSIGNMENT WHEREAS, the Metropolitan Area EMS Authority dba MedStar Mobile Healthcare ("Assignor") and ZOLL Medical ("Zoll") entered into a Clinical Trial Agreement, dated effective August 1, 2023 (the "Agreement") concerning a study related to pre -hospital ventilation; WHEREAS, the Assignee is in the process of transitioning its EMS operations to the City of Fort Worth ("Assignee"); WHEREAS, Assignor, Assignee, and Zoll have agreed to amend the Agreement as set forth herein; and WHEREAS, Assignor desires to assign, and Assignee desires to assume, the Agreement, as amended (collectively, the "Contract"), with the consent of Zoll; NOW, THEREFORE, Assignor, Assignee, and Zoll agree as follows: I. AMENDMENT The Agreement is hereby amended as follows: Section 4.3(e), entitled "Compliance with Laws" is hereby amended to read as follows: "Research Institution shall comply with all applicable laws and regulations concerning its use of the Beta Software, including without limitation if applicable all export and import control laws and regulations. Research Institution will not use the Beta Software for any purpose in violation of any applicable laws." Section 12.2, entitled "By Research Institution" under 12.0, entitled "Indemnification" is struck from the Agreement in its entirety. Section 14.0, entitled "Insurance" is hereby amended to include the following at the end of the existing provision: "The above notwithstanding, Research Institution is a governmental entity under the laws of the state of Texas and pursuant to Chapter 2259 of the Texas Government Code, entitled "Self -Insurance by Governmental Units," is self -insured and therefore is not required to purchase insurance. To the extent the Agreement requires Research Institution to purchase insurance, the parties agree that any such requirement shall be null and void and is hereby deleted from the Agreement and shall have no force or effect." OFFICIAL RECORD CITY SECRETARY FT. WORTH, TX Assignment Page 1 or 5 Section 16.0, entitled "Notices" is hereby amended to replace the information referring to Assignor with information relevant to Assignee, as follows: 100 Fort Worth Trail Fort Worth, Texas 76102 With copy to City Attorney's Office The Agreement is further amended such that all references to MedStar, "Research Institution" or "Institution" as defined by the Contract, shall refer to the City of Fort Worth. All other terms of the Agreement remain in full force and effect. II. ASSIGNMENT Assignor hereby assigns to Assignee all of its rights, duties, and obligations under the Contract, between Assignor and Zoll. Assignee agrees to assume and perform all duties and obligations required of Assignor under the terms of the Contract, as amended. This Assignment constitutes the entire agreement between Assignor and Assignee with respect to the subject matter hereof. No modification of any provision of this Assignment shall be effective unless in writing and signed by Assignor and Assignee. This Assignment shall inure to the benefit of and be binding upon Assignor and Assignee and their respective successors and assigns. This Assignment shall be governed by the laws of the State of Texas, without application of principles of conflicts of law. This Assignment may be executed in one or more counterparts each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Signed signature pages may be transmitted by facsimile or e-mail, and any such signature shall have the same legal effect as an original. �—� Dated the el day of t ,,) I405"_ 2025, Metropolitan Area EMS Authority dba MedStar Mobile Healthcare (Assignor) By: / Print: Frank Gresh G� t Title: Interim Chief Executive Officer Assignment Page 2 of 5 City of Fort Worth (Assignee): All,_ W44--A By: Valerie Washington (Jul 1, 2025 10:17 CDT) Name: Valerie Washington Title: Assistant City Manager Date: 07/01 /2025 CITY OF FORT WORTH INTERNAL ROUTING PROCESS: Approval Recommended: By: Name: Jeffrey Jarvis Title: EMS Chief Medical Officer Approved as to Form and Legality: By: Name: Taylor Paris Title: Assistant City Attorney Contract Authorization: M&C: N/A Contract Compliance Manager: By signing I acknowledge that I am the person responsible for the monitoring and administration of this contract, including ensuring all performance and reporting requirements. By: Name: Dwayne Howerton Title: AD Office of Medical Director City Secretary: p o� FORr4& Opted �o � OdII� aEXAao4p By: Name: Jannette S. Goodall Title: City Secretary OFFICIAL RECORD CITY SECRETARY FT. WORTH, TX Assignment Page 3 of 5 NOTARY ACKNOWLEDGEMENT On the day of V ilJ 2025, personally appeared Ta2U1k �-jY'c?SA , who acknowledged tome that (s)he is the Interim Chief Executive Officer of Metropolitan Area EMS Authority dba MedStar Mobile Healthcare ("Assignor"), and that (s)he executed this document for the purposes and consideration contained herein. Metropolitan Area EMS Authority dba edStar Mobile Healthcare By: Print. Frank Gresh / Title: Interim Chief Executive fficer SUBSCRIBED TO before me on this day of �L40e- 2025, MONICACRUZ My Notary 1D# 126504816 Notary Public in and for th tate of %P�YLtS ;E•a,,,�" EXpires May 20, 2028 y commission Expires- -WJ'] Assignment Page 4 of5 CONSENT TO ASSIGNMENT ZOLL Medical hereby consents to the assignment of the Clinical Trial Agreement, dated effective on or about August 1, 2023, as amended by the Amendment executed concurrently herewith (collectively, the "Agreement"), between ZOLL Medical and the Metropolitan Area EMS Authority dba MedStar Mobile Healthcare ("Assignor") to the City of Fort Worth ("Assignee"). ZOLL Medical acknowledges and agrees that Assignee shall assume all rights, duties, and obligations of Assignor under the Agreement, as amended, provided that Assignee complies with all terms of the Agreement. ZOLL Medical By: _C; 4 �UC Name: David Appleby Title: Director, Clinical Affairs ' d Biostatistics Date: May 27, 2025 Assignment Page 5 or5 DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC CLINICAL TRIAL AGREEMENT This Clinical Trial Agreement ("Agreement") is entered into by and between ZOLL Medical with offices at 269 Mill Road, Chelmsford, Massachusetts 01824 ("Sponsor") and Metropolitan Area EMS Authority dba MedStar Mobile Healthcare with offices at 2900 Alta Mere Drive, Fort Worth, Texas 76116 ("Research Institution"), effective as of the date of the last signature below. Capitalized terms not defined in the body hereof shall have the meaning ascribed in Exhibit A. In consideration of the mutual promises set forth herein and other good and valuable consideration the parties agree as follows: 1.0 Study 1.1 Participation. Sponsor hereby designates Research Institution as a patient treatment center in a clinical study ("Study") under the supervision of the Principal Investigator and Research Institution agrees to serve as such in accordance with the terms hereof. 1.2 Compliance with Protocol and with Laws. Research Institution shall comply and shall ensure that all Study Personnel comply with the Protocol, this Agreement, and Applicable Laws. Research Institution shall ensure that the Study Personnel: (a) are informed of and comply with the Research Institution's obligations, and representations and warranties under this Agreement; and (b) are obligated by an enforceable written agreement to comply with the terms of this Agreement. 1.3 Supervision. Research Institution shall: (a) be responsible and liable for the direct supervision and acts or omissions of all Study Personnel; and (b) ensure that the Study Personnel carry out Research Institution's obligations hereunder. 1.4 Subject Enrollment. Research Institution shall enroll Study Subjects in the Study in accordance with the Protocol and any additional written instructions provided by or on behalf of Sponsor. The duration of the Study may be extended or shortened, and the number of Subjects the Research Institution may enroll in the Study may be changed, upon the mutual written agreement of the parties and after obtaining the approval of this change, if necessary, from the Institutional Review Board ("IRB") and U.S. Food and Drug Administration ("FDA") in accordance with Applicable Laws. 1.5 Study Participation. Training, and Instruction. Sponsor shall provide Study Personnel with appropriate training and IFU for the Study Device and Study Materials in accordance with the Protocol. 1.6 Suspension. After a consultation with Sponsor, Research Institution may suspend participation in the Study if in the reasonable opinion of the Principal Investigator, the Study results support suspension of the Study due to health or safety concerns. Research Institution shall provide Sponsor with a detailed written explanation for and documentation supporting the suspension. 1.7 Location. Research Institution will conduct the Study (including without limitation the collection, use and storage of all Source Records and Study Data) only at the Facility and not at any other facilities without prior written approval from the Sponsor. 2.0 Institution and Investigators 2.1 Investigators. Institution shall ensure that: (a) all Sub -Investigators work under the supervision of the Principal Investigator; (b) the information provided by each Investigator is correct and complete; (c) each Investigator has the requisite privileges; is licensed or certified to practice medicine in the state where the Facility is located; is qualified by training and experience in medical device clinical research; and has expertise in the field of clinical research relating to the Study; DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 2 (d) the Investigators do not engage in any activity nor enter into any contract that would interfere with timely fulfillment of their obligations under this Agreement and the Protocol; (e) the Investigators and the Study Personnel timely make all notifications and registrations regarding their participation in the Study to the authorities and/or professional organizations as required by Applicable Laws; (f) prior to entering this Agreement, the Investigators and the Study Personnel have sought and received all authorizations from national and local agencies and/or professional organizations as required by Applicable Laws; and (g) prior to participation in the Study each Investigator signs and delivers to Sponsor: (i) Investigator's current curriculum vitae and a description of Investigator's experience relevant to the Study, including the dates, location, extent and type of that experience; (ii) a financial disclosure containing information requested by Sponsor; and (iii) an Investigator's Acceptance in the form attached as Exhibit B. 2.2 Replacement of Principal Investieator. (a) If the Principal Investigator becomes unwilling or unable to serve as Principal Investigator, Research Institution shall promptly notify Sponsor, and Research Institution shall diligently attempt to identify a replacement acceptable to Sponsor. Research Institution shall provide Sponsor with any reasonable documentation and assistance requested by Sponsor to evaluate the qualifications of any proposed substitute Principal Investigator. Sponsor shall notify Research Institution promptly of its decision either to continue the Study at the Facility with the substitute Principal Investigator or to terminate the Study at the Facility. In the event of continuation, the Research Institution shall ensure that the substitute Principal Investigator agrees to the rights and obligations of this Agreement and signs and delivers to Sponsor the documentation required by Section 2.1. The substitution of a Principal Investigator shall not affect the obligations of any individual or entity. (b) Sponsor reserves the right to terminate or replace the Principal Investigator if there is information available to Sponsor indicating that the Principal Investigator (i) has failed to perform his/her obligations under the Protocol, Applicable Laws, this Agreement or any other agreement between the Principal Investigator and Sponsor; (ii) is the subject to an inquiry that may result in his/her disqualification from serving as an Investigator; (iii) has repeatedly or deliberately failed to comply with the requirements of any authority; or (iv) has submitted false information to Sponsor, another sponsor/client, or any authority or notified body. 2.3 Representations and Warranties. (a) Research Institution represents and warrants that neither it nor, to the best of its knowledge, the Study Personnel: (i) has been found by any local, county, state or national authority, to have violated any Applicable Laws concerning the conduct of clinical investigations; (ii) has received a warning from such authority or other similar regulatory letter, or if it/he/she has, then all outstanding issues have been resolved to the satisfaction of the authority; (iii) has been excluded from participation in any government healthcare program, debarred from or under any other national program, convicted of any criminal offense, or otherwise deemed ineligible for participation in healthcare programs; (iv) has knowledge of any pending or potential actions that would give rise to any such ineligibility; (v) is the subject of a disqualification proceeding or has been disqualified as a clinical investigator pursuant to any authority rules; (vi) has been terminated from any investigation or research project by any local, county, state or national authority, or by a sponsor for clinical and medical misconduct; (vii) has had its/his/her right to provide healthcare restricted or suspended. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC (b) Institution additionally represents and warrants that (i) Institution and, to the best of its knowledge, the Study Personnel have the full and unrestricted right to disclose the information, know- how, materials, knowledge or data disclosed by Institution and/or the Study Personnel as contemplated by this Agreement; (ii) Institution and Study Personnel have, and shall maintain throughout the term of the Study, all necessary licenses, permits, immunizations, and authorization to conduct the Study; (iii) all electronic records shall be transmitted to Sponsor in accordance with all Applicable Laws; (iv) Institution's and all Study Personnel's performance under this Agreement and arrangements with each other and with all individuals and entities providing services under the Study comply with and shall comply with (x) the federal anti -kickback statute (42 U.S.C. §1320a-7(b), as amended) and the related safe harbor regulations, and (y) those limitations on certain physician referrals, also referred to as the "Stark Law" (42 U.S.C. § 1395nn, as amended); (v) all Institution's electronic health record systems contain adequate controls to ensure the reliability, quality, integrity and traceability via the audit trail of the source data (as that term is defined in the September 2013 FDA Guidance for Industry on Electronic Source Data in Clinical Investigations ("ESD Guidance")) contained in the such system; (vi) all source data in such system are attributable, legible, contemporaneous, original and accurate, and are otherwise compliant with the ESD Guidance; and (vii) Investigators using electronic signatures to review and sign completed electronic Case Report Forms and documents generated using such EHR system comply with 21 C.F.R. Part 11, Subpart C. 2.4 No Conflicts. Research Institution represents and warrants that neither it nor any Study Personnel is bound by or will be bound by any agreement or under any obligation that would prevent it/him/her from entering into this Agreement or which would adversely affect the conduct of the Study or performance under this Agreement. 2.5 Continuing Validitv. Research Institution shall notify Sponsor in writing within five (5) days of any change to the foregoing representations and warranties. 2.6 Acceptances. Institution shall require each Investigator to sign and deliver to Sponsor an Investigator Acceptance in the form attached as Exhibit B prior to participation in the Study. 3.0 IRB Annroval and Data Protection 3.1 IRB Approval. Research Institution shall ensure that a competent IRB perform a prospective review prior to enrolling any Study Subjects and continues to perform reviews of all terms and conditions related to the Study, including the IFU, the Protocol, and the participation of the Research Institution and the Study Personnel in the Study at the Facility in addition to the requirements of Applicable Law. 3.2 Modifications. All modifications to the Protocol shall be initiated by the Sponsor and shall not be implemented until receipt of all necessary approvals. 4.0 SuDWv of the Studv Device and Beta Software 4.1 Supply. The Sponsor will supply the Research Institution with Study Devices and necessary Study Materials at the cost, if any, specified in the Budget. The Study Device and Study Materials remain at all times the sole property of the Sponsor. The Sponsor shall maintain the Study Devices at the Facility. 4.2 Security. Research Institution shall keep the Study Devices and the Study Materials in a locked, secured area at the Facility at all times when not in use. Research Institution shall ensure that the Study Devices and Study Materials are used only to conduct the Study, and for no other purpose. Research Institution will not allow the Study Device and Study Materials to be moved, altered, disassembled, reverse engineered or in any way tampered with, except by authorized representatives of DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 4 the Sponsor. Research Institution shall use and ensure the Study Personnel use the Study Device and Study Materials only according to the Protocol and the Instructions for use of the Study Device and Study Materials. Should the Study Device or Study Materials be damaged for any reason beyond normal wear and tear, Research Institution shall promptly notify Sponsor and follow Sponsor's instructions regarding use and repair. Research Institution shall pay for repairs if such damage arises from Research Institution's negligence or willful misconduct while in the Research Institution's possession. Upon termination or completion of the Study or this Agreement, or upon request by Sponsor, the Study Devices and Study Materials (in good condition, reasonable wear and tear excepted) shall be returned to Sponsor or destroyed at Sponsor's sole option and expense. 4.3 Beta Software. (a) Subject to the terms and conditions of this Agreement, Sponsor grants to Research Institution during the Term of this Agreement a non-exclusive, non -transferable license to install and use the Beta Software in executable code form solely for the purposes of carrying out the Study pursuant to this Agreement. (b) Except as expressly permitted by this Agreement, Research Institute shall not, and shall not permit any third party, to: (a) use, reproduce, modify, adapt, alter, translate, or create derivative works from the Beta Software or Documentation; (b) merge the Beta Software with other software; (c) sublicense, distribute, sell, use for service bureau use, lease, rent, loan, or otherwise transfer the Beta Software or Documentation to any third party; (d) reverse engineer, decompile, disassemble, or otherwise attempt to derive the source code for the Beta Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation; (e) remove, alter, cover or obfuscate any copyright notices or other proprietary rights notices included in the Beta Software; (f) use the Beta Software to upload, store or transmit protected health information or other live data; or (g) otherwise use or copy the Beta Software or Documentation except as expressly permitted hereunder. Research Institute agrees to install and use the Beta Software in strict compliance with this Agreement. (c) THE BETA SOFTWARE AND DOCUMENTATION ARE EXPERIMENTAL BETA VERSIONS AND ARE PROVIDED "AS IS". SPONSOR EXPRESSLY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THE BETA SOFTWARE, THE DOCUMENTATION AND ANY DATA, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON -INFRINGEMENT OF THIRD -PARTY RIGHTS AND ANY WARRANTY WITH RESPECT TO THE STORAGE, ARCHIVING OR RETRIEVAL OF ANY DATA. RESEARCH INSTITUTION ACKNOWLEDGES THAT IT HAS RELIED ON NO WARRANTIES AND THAT NO WARRANTIES ARE MADE HEREIN BY SPONSOR OR ANY OF ITS REPRESENTATIVES OR SUPPLIERS WITH RESPECT TO THE BETA SOFTWARE OR DOCUMENTATION. Research Institution acknowledges and agrees that, in entering into this Agreement, it has not relied upon the future availability of any new or enhanced feature or functionality, or any new or enhanced product or service, including, without limitation, updates or upgrades to Sponsor's existing products and services. Sponsor shall not have any obligation to develop, productize, maintain, support, repair, offer for sale or any other way continue to provide or develop the Beta Software either to or for Research Institution or any other party. Sponsor's performance obligations hereunder are limited to those expressly enumerated herein. (d) LIMITATION OF LIABILITY. IN NO EVENT WILL EITHER PARTY OR ANY OF ITS EMPLOYEES, REPRESENTATIVES OR SUPPLIERS BE LIABLE FOR ANY INDIRECT, CONSEQUENTIAL, EXEMPLARY, SPECIAL, OR INCIDENTAL DAMAGES, INCLUDING WITHOUT LIMITATION ANY LOST DATA, LOST PROFITS AND COSTS OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, ARISING FROM OR RELATING TO THE BETA SOFTWARE, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC (EXCLUDING GROSS NEGLIGENCE), EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. (e) Compliance with Laws. Research Institution shall comply with all applicable laws and regulations concerning its use of the Beta Software, including without limitation if applicable all export and import control laws and regulations. Research Institution will not use the Beta Software for any purpose in violation of any applicable laws. Research Institution agrees to defend, indemnify, and hold harmless Sponsor from and against any and all liabilities, losses, expenses, damages and claims that arise out of violation of any applicable laws or regulations by Research Institution or any of its agents, officers, directors, or employees. (f) Assignments. Research Institution may not assign or transfer, by operation of law or otherwise (including in connection with a sale of substantially all assets or equity, merger or other change in control transaction), any of its rights to use the Beta Software to any third party without Sponsor's prior written consent. Any attempted assignment or transfer in violation of the foregoing will be null and void. (g) The Beta Software, the user's manuals and other materials provided to Research Institution in connection with the Beta Software (the "Documentation"),and any and all existing or future copyrights, trademarks, service marks, trade secrets, patents, patent applications, know how, moral rights, contract rights, and proprietary rights, and all registrations, applications, renewals, extensions, combinations, changes, modifications, corrections, enhancements and improvements in the foregoing ("Intellectual Property Rights"), are and shall be the exclusive property of Sponsor (or, as the case may be, its licensors and suppliers). All rights in and to the Beta Software not expressly granted to Research Institution in this Agreement are reserved by Sponsor (or, as the case may be, its licensors and suppliers). To the extent the Beta Software contains software owned by a party other than Sponsor ("Third Party Software") for which Sponsor has a license agreement with a third party, the Beta Software and all rights granted hereunder are expressly limited by and subject to any license agreements Sponsor may have for such Third -Party Software. 5.0 Informing Sponsor 5.1 Required Reporting. Research Institution shall timely submit the Study Data to Sponsor and/or Sponsor designated representative. Case Report Forms shall be submitted within the time periods set forth in the Protocol. Invoices for work related to a Study Subject will not be due or payable until all related Study Data is properly reported to Sponsor in accordance with the Protocol. All Source Records shall remain the property of the Research Institution and Research Institution shall make them available for inspection as provided herein. Research Institution shall provide any additional data, access or assistance reasonably requested by Sponsor, including site visits on twenty-four (24) hours' notice, in connection with Sponsor's approval or clearance of the Study Device. 5.2 Adverse Events. Research Institution shall promptly notify Sponsor of each Adverse Event as defined in the Protocol. If the Adverse Event is an Unanticipated Adverse Device Effect (as defined in 21 CFR Part 812), then notice of such event shall be given to Sponsor and the IRB, if necessary, as soon as possible, but in no event later than twenty-four (24) hours after an Investigator first learns of the event. Research Institution shall provide to Sponsor all available associated source documentation, including but not limited to laboratory reports, death summary and operative reports, for each Adverse Event. Research Institution shall notify Sponsor in writing within twenty-four (24) hours of any communication from the IRB and any state or national authority in relation to the reporting of adverse events. To the extent permitted by the authority, Research Institution will not provide any response, either written or oral, to such IRB or to any authority without the prior written approval of Sponsor and will not permit the Study Personnel to do so. If Sponsor becomes aware of any complaint as defined in 21 C.F.R. 820.3(b) or any other reportable event as defined in 21 C.F.R. 803.3 (Medical Device Reporting), Research Institution shall cooperate with Sponsor in Sponsor's investigation of such complaint or event, DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 0 and shall promptly provide all assistance reasonably requested by Sponsor, including without limitation by submitting to Sponsor all associated documentation (e.g., lab reports, death summary, operative reports, etc.) for each such complaint or reportable event to enable Sponsor to conduct an adequate complaint investigation and to make medical device reporting decisions. 5.3 Withdrawal of IRB or Authoritv Approval. Research Institution shall notify Sponsor within the time period set forth by Applicable Laws if the IRB or an authority withdraws or alters its approval or authorization of the Study at the Facility, and within twenty-four (24) hours by telephone and email (with a follow-up by mail) if the IRB withdraws or alters its approval of any Investigator's participation in the Study at the Facility. 5.4 Correspondence with IRB and the authorities. Research Institution shall timely send Sponsor a copy of all correspondence with the IRB and FDA, including any correspondence relating to continuing review. Research Institution shall notify Sponsor in writing within twenty-four (24) hours of any communication from IRB and any national or state authority. To the extent permitted by the IRB or the authority, Research Institution will not provide any response, either written or oral, to the IRB or to any authority without the prior written approval of Sponsor. 5.5 Protocol Deviations. In the event of any deviation from the Protocol, Research Institution shall record such deviation on a protocol deviation log (including the date, reason and corrective action taken to reduce the chance of repeating this deviation in the future) and shall promptly inform the Sponsor thereof, and, in the event of a major deviation (as defined in the Protocol), Research Institution shall notify the Sponsor no later than two (2) days after the major deviation occurs. 5.6 Subject Withdrawal. If a Study Subject withdraws or is withdrawn from the Study, Research Institution, shall promptly determine the reason for the discontinuance and promptly inform Sponsor thereof by completing and returning to Sponsor any forms required by the Protocol. 6.0 Data Storage and Access 6.1 Collection and Storage of Data. Research Institution shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data and Source Records in accordance with Applicable Laws, the Protocol and this Agreement and shall cooperate with Sponsor and its representatives in promptly resolving any data inquiries. Research Institution shall: (a) protect the Study Data and Source Records from unauthorized use, access, duplication, disclosure, loss or damage. Research Institution shall not destroy any Study Data or Source Records that are directly related to the Study without Sponsor's prior written permission. 6.2 Access. Research Institution shall allow the Sponsor, its representatives, and government agencies reasonable access to the Facility and records directly used and/or directly related to the conduct of the Study to permit monitoring the Study and reviewing, inspection and copying of Study Data, and Source Records for the processing of personal data. Unless prohibited from doing so, Research Institution shall: (a) notify Sponsor by telephone and email (with follow-up by mail) promptly after learning that a government agency or IRB inspection is scheduled to take place, or, if there is no prior notice, that an inspection has commenced; (b) make reasonable efforts to coordinate scheduling of such inspections to permit Sponsor to attend; (c) provide Sponsor with copies of all Study Data, Source Records and any other materials, correspondence and documents it receives, obtains, or generates in connection with any inquiries from or communications with the government agencies or IRB; (d) make reasonable efforts to segregate, and not disclose, any Research Results (defined in Section 8.2), Source Records and other materials, correspondence and documents that are not required to be disclosed during such an inspection, including financial data and pricing information; (e) promptly provide to Sponsor a copy of any inspection report or other document, request or demand issued by an government agency or IRB and consider Sponsor's comments to the draft response before it is sent to the government agency or IRB. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 7 Research Institution shall not, either during or after inspections, provide any government agency or IRB with any information or any undertakings without the prior review of Sponsor. If any observations are made by any authority, or IRB related to the Study, Research Institution shall promptly send a copy of such document to Sponsor. 7.0 Publications and Public Disclosure 7.1 Publication The Research Institution shall have the right to Publish the results of and disseminate information about the activities conducted under this Agreement in accordance with the Protocol. 7.2 Confidentiality of Unpublished Data. In recognition of Sponsor's legitimate business interest in keeping Study Data and Source Records that are not Published in accordance herewith ("Unpublished Data") from being made available to its competitors, Research Institution shall (a) keep all Unpublished Data confidential in accordance with Section 9; and (b) not disclose or otherwise make available any Study Data, Study Devices, Study Materials or Source Records outside of the publication procedures set forth above. 7.3 Media Contacts. Research Institution shall not, and shall ensure that Study Personnel do not, engage in interviews or other contacts with the media, including but not limited to newspapers, radio, television, the Internet, and social networking, related to this Agreement, the Study or the Device without the prior written consent of the Sponsor. This provision does not prohibit disclosure of Study Data in accordance with the Protocol. 7.4 Use of Names. Except as necessary to comply with reporting and disclosure requirements, each party will obtain prior written permission from the other before using the name, symbols and/or marks of the other in any form of publicity in connection with the Study. Permission shall not be necessary to make any legally required disclosure that identifies the existence of the Agreement, the party's names and/or compensation paid. Further, Sponsor may use the name, symbols and/or marks of Research Institution and names of Investigators, provided that such use or naming shall be limited to identification of Research Institution as a Study Site, and the Investigators as Study investigators. 8.0 Ownership 8.1 Pre-existing Intellectual Property. Ownership of Pre-existing Intellectual Property is not affected by this Agreement, and no party hereunder shall have any claims to or rights in any Pre-existing Intellectual Property of any other party hereunder. 8.2 Research Results. Sponsor shall own all right, title and interest in and to the Research Results. Sponsor may, in Sponsor's sole discretion, use the Research Results for any purpose. Research Institution hereby confirms that all Study Personnel are required by enforceable agreement with Research Institution to timely transfer to Research Institution all their rights in the Research Results. Research Institution shall promptly and fully disclose all Inventions to Sponsor in writing. Research Institution hereby assigns to Sponsor (i) all of its right, title and interest in and to the Research Results, including all patents, copyrights and other intellectual property and proprietary rights; and (ii) all rights of action and claims for damages and benefits arising due to past and present infringement of said rights. Research Institution shall assist Sponsor, at Sponsor's expense, and cause its Study Personnel to assist and cooperate with Sponsor in creating, preparing, and executing all documents reasonably necessary for Sponsor to secure, perfect, effectuate and preserve Sponsor's ownership rights in the Research Results. 8.3 Use of Studv Data. Subject to the other provisions of this Agreement, Sponsor grants to Research Institution the right to use Study Data for its own internal patient care, research, and educational purposes. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 9.0 Confidential Information 9.1 Obligations. Research Institution shall use the Confidential Information solely for the performance of the Study and shall not disclose the Confidential Information to any third party, except as permitted by this Agreement or as authorized in writing by Sponsor. Research Institution shall: (a) limit dissemination of Confidential Information to only those personnel having a "need to know" and who are advised of the confidential nature of such information; (b) have appropriate agreements with Study Personnel sufficient to enable them to comply with the confidentiality and nondisclosure obligations contained herein; and (c) use reasonable measures to protect the Confidential Information from disclosure, including removing any Confidential Information from Publications as requested by Sponsor. 9.2 Compelled Disclosure. If Research Institution receives notice of a third party seeking to compel disclosure of any Confidential Information, it shall provide Sponsor with prompt notice so that Sponsor may assist Research Institution in seeking, or Sponsor may itself seek, a protective order or other appropriate remedy. If such protective order or other remedy is not obtained, Research Institution shall furnish only that portion of the Confidential Information which it is advised by its counsel, in consultation with Sponsor, is legally required to be disclosed, and shall exercise its best efforts to obtain reliable assurance that the Confidential Information will be afforded confidential treatment. 10.0 Term and Termination 10.1 Term. This Agreement shall commence on the Effective Date and shall continue in effect until completion of all obligations herein, unless earlier terminated pursuant to this Section 10.0. 10.2 Termination by Research Institution. Research Institution may terminate this Agreement for any Material Breach by Sponsor that remains uncured for a period of thirty (30) days after written notice. 10.3 Termination by Sponsor. Sponsor may terminate or suspend performance under this Agreement with respect to any or all parties hereto, with or without cause at any time or for any reason or no reason at all, effective immediately upon written notice. 10.4 Effect of Termination. Upon receipt of a notice of termination, Research Institution shall immediately stop enrolling Subjects in the Study. Research Institution shall provide the Study Data (including CRFs) required under the Study for Subjects who were enrolled in the Study prior to the receipt of the notice of termination, unless instructed otherwise by Sponsor in writing. The terms of this Agreement shall continue to apply with respect to all such follow-up testing and data, and Research Institution shall promptly respond to requests from regulatory authorities and Sponsor for information relating to the conduct of the Study. Research Institution shall comply with Sponsor's instructions regarding the return or destruction of Confidential Information and Sponsor Property to Sponsor. In addition, upon expiration or termination of this Agreement for any reason: (a) all licensed rights to the Beta Software granted hereunder will immediately cease to exist, except to the extent necessary to provide any data required by the Protocol; and (b) Research Institution must promptly discontinue all use of the Beta Software, erase all copies of the Beta Software from Research Institution's computers and return to Sponsor or destroy all copies of such Beta Software and related Documentation on tangible media in Research Institution's possession or control. Upon Sponsor's request, Research Institution will provide a written certification (in the form acceptable to Sponsor), certifying as to Research Institution's compliance with its post -termination obligations set forth in this Section 10.4. 10.5 Pavments After Earlv Termination. In the event of termination of this Agreement prior to completion of the Study at the Facility, Research Institution shall minimize further costs. Except in instances where Sponsor terminates this Agreement for Material Breach, Sponsor shall reimburse Research Institution for any work performed and all non -cancellable costs prior to termination and all required DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 0 follow-up testing, in accordance with the Budget. Only services and time expenditures that are compensated under the payment schedule shall be compensated upon termination, and Sponsor shall not be responsible for any lost profits or lost opportunities. 10.6 Survival. In addition to any provisions that by their nature survive expiration or termination of this Agreement, Sections 2, 6-9 and 11-15 shall survive the termination or expiration of this Agreement for any reason. 11.0 Pavment; Transoarencv 11.1 General. As consideration for performance of the Study, Sponsor shall pay and/or reimburse Research Institution according to the Budget. All payments set forth in the Budget are inclusive of all associated costs, fees, and charges, including overhead. Sponsor will not be obligated to pay for or reimburse Research Institution for any expenses that fall outside any of the categories set forth in the Budget or that exceed the amount allocated for such categories in the Budget. Research Institution will ensure that the judgment of the Study Personnel with respect to advice to and care of each Subject is not influenced by the compensation Research Institution receives hereunder. Payments for work related to a Study Subject will not be due or payable until all related Study Data is properly and timely reported to Sponsor in accordance with the Protocol. 11.2 Basis of Compensation. The parties acknowledge and agree that the compensation set forth herein represents the fair market value of the services to be provided by Research Institution to Sponsor, negotiated in an arm's-length transaction, and has not been determined in a manner which takes into account the volume or value of referrals or business, if any, that may otherwise be generated between Sponsor, on the one hand, and Research Institution, on the other. Nothing contained in this Agreement, including any payment hereunder, is intended to be, nor shall it be construed as (a) an obligation or inducement, either express or implied, for Research Institution to purchase, prescribe, promote or otherwise support specific Sponsor products; (b) a reward for any such purchase, prescription, promotion or other support by Research Institution; or (c) a requirement that Research Institution refer any patients or other business to Sponsor, or enroll any Subjects in the Study. The parties acknowledge and confirm that no such expectations exist. 11.3 Submission Limits. Research Institution shall not, and shall ensure that Study Personnel do not (a) submit claims for or retain payment by any patient, third -party payor or any other person or entity for any item, procedure or service that has been paid for or provided without charge by Sponsor; or (b) seek or retain payment from Sponsor for any item, procedure or service that is reimbursed by any patient, third - party payor or any other person or entity. 11.4 Financial Revortin2 and Disclosure by Sponsor. Sponsor will have the right in its discretion (a) to disclose (i) information relating to the services performed pursuant to this Agreement, including without limitation all payments, reimbursement for expenses, or other transfer of value made in other than currency form; (ii) identifying information concerning Research Institution; and (iii) any other information relating to this Agreement or to the Study; (b) to display such information, including but not limited to, on Sponsor's websites; and (c) to disclose such information to employers and affiliated institutions of Research Institution, to any other individuals or entities involved in the Study, and to regulatory authorities or professional bodies. 11.5 Financial Revortin2 and Disclosure by Research Institution and Investigators. (a) Records. Research Institution shall keep all books, contracts, records, documents and other evidence regarding all payments made, and costs, expenditures and expenses incurred in connection with the services performed pursuant to this Agreement and shall provide Sponsor with information and supporting evidence regarding these payments, costs, expenditures and expenses within thirty (30) days after Sponsor's request. Research Institution shall make such information and records DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 10 available to Sponsor and its representatives for inspection and audit to enable Sponsor to comply with the Applicable Laws during and after the term on this Agreement. (b) Disclosure. To the extent necessary to comply with Applicable Laws, journal guidelines and industry practices, Research Institution will disclose and ensure that the Study personnel disclose (i) the Sponsor's funding and support of the Study; and (ii) any significant financial or other relationship between Sponsor and Research Institution, and/or between Sponsor and any Investigator, as applicable (e.g. employee, consultant, owner of equity interest in Sponsor or Sponsor's products, etc.). This obligation shall include, without limitation, disclosure to medical journals or other publications, to hospitals and affiliated institutions, to individuals and entities involved in the Study, to patients in any presentations when discussing Sponsor or any Sponsor products, and to any government agencies and licensing authorities which require such disclosure. 12.0 Indemnification 12.1 By Sponsor. Sponsor shall indemnify, defend, and hold harmless Research Institution and its Study Personnel from and against all Indemnified Liabilities to the extent resulting from any third -party claims, actions, or proceedings seeking compensation for Research Injuries but solely to the extent that such Indemnified Liabilities do not arise out of or in connection with: (i) Institution Indemnitees' or a third- party's negligence or willful misconduct in using or maintaining the Study Device; (ii) failure to follow Applicable laws or to conform to reasonable and prudent clinical practices by Institution Indemnitees; or (iii) failure to follow the Protocol, the IFU and/or this Agreement by Institution Indemnitees. 12.2 By Research Institution. Research Institution shall indemnify, defend, and hold harmless Sponsor, its affiliated entities and their respective employees, agents, and contractors from and against all Indemnified Liabilities that result from (a) wrongful or negligent actions or omissions, or willful misconduct by Research Institution or its Study Personnel and/or (b) failure by Institution or Study Personnel to follow Applicable Laws, the Protocol, the IFU, or this Agreement. 12.3 Conditions of Indemnitv. The Party claiming a right of indemnification or defense under this Agreement shall (a) provide the indemnifying party prompt notice (in all events within thirty (30) days) and a copy of any such claim; and (b) cooperate fully with the indemnifying party and its legal representatives at the indemnifying party's expense. The indemnifying party shall have the right to exercise sole control over the defense and settlement of any such complaint or claims, including the sole right to select defense counsel and to direct the defense or settlement of any such claim or suit; provided that the indemnifying party shall not enter into any non -monetary settlement or admit fault or liability on the indemnified party's behalf without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld or delayed. If the indemnifying party assumes the defense of the indemnified party, the indemnified party shall nevertheless have the right to select and to obtain representation by separate legal counsel at its own expense. If the indemnified party exercises such right, all costs, expenses incurred by the indemnified party for such separate legal counsel shall be borne by the indemnified party. A party shall be relieved of its indemnification obligations if (a) an indemnified party fails to follow the procedures set forth herein; (b) compromises or settles any Claim for which indemnification is available hereunder without the indemnifying party's prior written approval; or (c) makes any admission or takes any other action with respect to any claim for which indemnification is available hereunder, that is prejudicial to the defense of such claim, without indemnifying parry's prior written approval. 13.0 Studv Subiect Iniury Subject to the provisions of this paragraph, Sponsor shall pay the cost of medical care for any injury or illness that first appears while the subject is being treated with the Study Device or a Study specific procedure (one that is not performed as part of regular care and would not be performed if the subject were DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 11 not participating in the Study), and that is determined by Sponsor and the Investigator to be a direct result of being treated with the Study Device or undergoing such Study specific procedure in accordance with the Protocol. Injury or illness related to the Study Device does not include worsening or advancement of the illness or condition for which Study Device was prescribed or any medical condition a subject may have had before being treated with the Study Device. Sponsor's payment of such costs (net of co-insurance and deductibles) shall be limited to the lowest rate accepted by Research Institution as a participating provider with any third -party payor, in each case, where available and appropriate for the devices, equipment or services provided. Notwithstanding the foregoing, Sponsor shall have no liability for such amounts to the extent the Research Injury is caused by: (a) gross negligence or willful misconduct by Research Institution or Study Personnel; (b) failure by Institution or Study Personnel to follow Applicable Laws; or (c) failure by Institution or its Study Personnel to follow the Protocol, the IFU, or this Agreement. The obligations set forth in this Section 13.0 are Sponsor's sole liability with respect to the payment of medical expenses for Study Subjects. This Section is not intended to create any third -party contractual benefit for any participants in the Study. 14.0 Insurance Research Institution shall maintain clinical study insurance coverage, professional liability insurance coverage and general liability insurance coverage sufficient to cover its obligations under this Agreement and the negligence and malpractice of the Study Personnel, which coverage shall be primary to any insurance coverage that Sponsor may maintain. The insurance policies shall include coverage for contractually assumed liabilities and shall not exclude liability arising from the conduct of clinical studies. Sponsor shall maintain commercial general liability coverage and clinical study coverage. Each Party shall provide the other Party, upon request, with its certificate of insurance. The coverage shall remain in place throughout the term of the Study, and for a period of five (5) years thereafter. 15.0 Limitation of Liabilitv Except for liability arising under Section 9.0 (Confidential Information) and Section 12.0 (Indemnification), in no event shall either party hereunder be liable to the other party hereunder for special, incidental, consequential or indirect damages arising from or in relation to this Agreement, the Protocol or the Study Device (whether in contract, tort, negligence, strict liability, by statute or otherwise). This limitation shall apply even if such party has been advised or is aware of the possibility of such damages. Except for Sponsor's obligations under section 12 and 13, Sponsor's maximum aggregate liability to any other party hereunder for any claim related to, or in connection with, this agreement, the Protocol or the device (whether in contract, tort, negligence, strict liability, by statute or otherwise) shall be limited to an amount equal to the total payments by Sponsor pursuant to the Budget. 16.0 Notices Any notices under this Agreement shall be in writing and delivered to the parties at the postal addresses set forth above, or to the postal address subsequently provided by a party in accordance with this section, by (a) first class certified mail, return receipt requested, with notice deemed given upon receipt; or (b) an internationally -recognized overnight courier service, with notice deemed given on the date of receipt as indicated on the courier's receipt. Email addresses may be listed as a matter of convenience but shall not be used for any notices required by this Agreement unless the Agreement expressly provides otherwise. 17.0 Independent Contractors Research Institution is an independent contractor of Sponsor, and no Investigator, nor any Study Personnel DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 12 or agents or employees of Research Institution shall be considered to be an employee, partner, joint venturer or agent of Sponsor. Neither Research Institution, nor any Study Personnel shall have the authority to legally bind Sponsor. 18.0 Miscellaneous This Agreement, including all Exhibits, all of which are incorporated herein by reference, constitutes the entire agreement among the parties with respect to the subject matter herein and supersedes all prior and contemporaneous agreements, including without limitation, any prior non -disclosure or confidentiality agreements, whether written or oral, of the parties hereto, relating to the subject matter herein. This Agreement may be amended only by a writing signed by the parties. This Agreement shall be binding upon the parties, their legal representatives, successors, and assigns No party may assign or otherwise transfer this Agreement, or any rights or obligations hereunder, without the other's prior written consent. This Agreement and the rights and obligations of the parties hereunder shall be governed by and interpreted, construed, and enforced in accordance with the laws of Texas, exclusive of its choice of law rules. If any provision of this Agreement is for any reason found to be unenforceable, the remainder of this Agreement shall continue in full force and effect. Failure to enforce any rights hereunder, regardless of the length of time such failure continues, shall not constitute a waiver of those or any other rights. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same agreement. Signatures submitted by facsimile, pdf, or other electronic means, shall have the same force and effect as original signatures, and shall be valid and binding upon the parties hereto. IN WITNESS WHEREOF, each party has caused this Agreement to be executed by its duly authorized representative as of the Effective Date. ZOLL Medical Corporation DocuSigned by: By: r�e� Metropolitan Area EMS Authority dba g,McNobile Healthcare By �t,�n�ti.t& �. Slls&& oea�ee«.�aa44ese... David Appleby Name: Name: Kenneth J. Simpson Title: Director, Clinical Affairs and Bi ostatifj�iEEO Date: 7/24/2023 Date: 8/1/2023 DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 13 EXHIBIT A DEFINITIONS (a) Applicable Laws means applicable federal and state laws, regulations, and guidelines relating to Study Personnel or the conduct of the Study, including but not limited to the Federal Food Drug and Cosmetics Act, the Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act, and regulations promulgated thereunder, the International Conference on Harmonization (ICH) guidelines, and the Declaration of Helsinki, the CIOMS International Ethical Guidelines For Biomedical Research Involving Human Subjects, and good clinical practices as applicable to device studies including, without limitation, the requirements to ensure that an Internal Review Board provide prior and continuing review, and approval for the conduct of the Study. (b) "Beta Software" means the beta version of Sponsor's RescueNet® VentReview software. (c) Budget means the budget for the Study set forth on Exhibit C hereto. (d) Confidential Information means the confidential and proprietary information of Sponsor including (a) the terms of this Agreement; (b) all information disclosed by or on behalf of the Sponsor to Institution such as technical information relating to the Study Devices and Study Materials; (c) the Protocol, Study enrollment data, information about the status of the Study, communications to and from any authority, information relating to the Device's regulatory status, and correspondence to or from FDA; (d) Research Results; (e) Unpublished Data•, and (f) the Beta Software, including any routines, subroutines, directories, tools, programs, or any other technology included therein, and the Documentation (as such term is defined in Section 4.3). Confidential Information shall not include information that can be shown by documentation: (i) to have been public knowledge prior to or after Sponsor's disclosure, other than through acts or omissions attributable to Institution; (ii) to have been in the possession of Institution from sources other than Sponsor that did not have an obligation of confidentiality to Sponsor prior to Sponsor's disclosure; or (iii) to have been independently developed by Institution prior to Sponsor's disclosure. (e) CRA means a clinical research associate. (f) CRF means case report forms submitted by Institution to Sponsor pursuant to the Protocol. (g) Facilities means MedStar Mobile Healthcare. (h) IFU or Instructions for Use means the written instructions for use of the Study Device and Study Materials. (i) Indemnified Liabilities means all liabilities, damages, losses, claims and expenses, including court costs, expert witness fees and reasonable attorneys' fees subject to indemnification under Section 12. 0) Institution means Research Institution. (k) Investizators means the Principal Investigator and any Sub -Investigators. (1) Inventions means all inventions, technologies, know-how, ideas, processes, algorithms, programs, discoveries, improvements, designs, devices, drawings, concepts, prototypes, samples, models, technical information, materials, trade secrets and specifications that are conceived, first reduced to practice or created in connection with the Study or otherwise related to Sponsor's Confidential Information, whether by invented by Sponsor, Institution, or Study Personnel, individually or jointly. (m) Material Breach means a failure to perform under the Agreement significant enough to deprive the non -breaching party of its expected benefit of the Agreement. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 14 (n) Pre-existing Intellectual Propertv means inventions, technologies, know-how, ideas, processes, techniques, algorithms, programs, discoveries, improvements, devices, concepts, designs, prototypes, samples, models, technical information, materials, drawings, specifications and other works of authorship existing as of the Effective Date, and all patents, copyrights, trade secret rights and other intellectual property rights therein. (o) Principal Investigator means Jeffrey Jarvis, MD, or a duly appointed replacement. (p) Protocol means ZOLL Protocol No. 76701 entitled Pre -Hospital Ventilation, as modified from time to time. (q) Publish means to publish, present or otherwise publicly disclose or discuss. (r) Research Iniury means bodily injury or death of a Study Subject caused by i) the Study Device used in accordance with the IFU and Protocol or ii) a properly performed procedure required by the Protocol that would not have been performed but for the Protocol. The term does not include the natural progression of an underlying or pre-existing condition (whether previously diagnosed or not), or events that would have been expected from the standard treatment using currently approved therapies for the Study subject's condition. (s) Research Results means the Inventions and the Study Data. (t) Source Records means all information and data collected or prepared in connection with the Protocol other than Study Data, such as medical records, device records, source worksheets, x-rays, CT scans, MRIs, other diagnostic images, and all other primary data sources underlying data recorded on the Case Report Forms. (u) Studv Data means all information in the CRFs and any other records, reports, and data pertaining to Study Subjects that are delivered to Sponsor pursuant to the Protocol or this Agreement. (v) Studv Device means ZOLL 731 Series ventilator. (w) Studv Materials includes disposables and materials provided by the Sponsor to conduct the Study in accordance with the Protocol, including regulatory and training documents and the Beta Software. (x) Studv Personnel means all Research Institution employees, agents and contractors (including all Investigators) involved in the conduct of the Study. (y) Studv Subiects means the individuals enrolled as subjects in the Study. (z) Sub -Investigators means collaborating physicians participating in the Study appointed by Institution with Sponsor's prior written approval. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 15 EXHIBIT B INVESTIGATOR ACCEPTANCE The undersigned physician wishes to participate as an investigator in the clinical study titled Pre -Hospital Ventilation study described in the Clinical Trial Agreement ("Agreement") among ZOLL Medical and Metropolitan Area EMS Authority dba MedStar Mobile Healthcare Capitalized terms have the meanings set forth in the Agreement. To induce Sponsor to accept such participation, the undersigned (a) agrees to perform the obligations of the Investigators under the Agreement (b) acknowledges that s/he has received copies of, read and understands the Agreement, the Protocol and related materials provided by Sponsor; (c) confirms that s/he shall comply in all respects with the Agreement and the Protocol (including the undertakings of the Research Institution therein) to the extent applicable to him/her including without limitation Sections 7 (Publications), 8 (Ownership) and 9 (Confidentiality); (d) affirms that the representations and warranties made by the Research Institution in the Agreement about him/her are true and complete; (e) agrees to promptly inform Sponsor if any of such representations and warranties become untrue; and (f) confirms that s/he understands the obligations and responsibilities of the investigators under Applicable Laws. Investigator name and address F;DocuSigned by: Signature: .� Sl kv Date: 8/1/2023 DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC 16 EXHIBIT C BUDGET Sponsor will pay Research Institution $150 for every case enrolled in the study with Enrollment CRF and Ventilator and X Series Data File CRF completed. Sponsor will pay for all IRB fees in connection with the Study. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC ZOLL PROTOCOL SUMMARY Title: Pre -Hospital Ventilation Study 269 Mill Road Chelmsford, MA 01824 978.421.9655 (main) 978.421.0025 (fax) www.zoll.com An Asahi Kasei Group Company Summary: There is currently not much known about existing pre -hospital ventilation strategies including modes typically used, alarm parameters, frequency and type of changes to vent settings, as well as ventilation quality. With this project, we will develop a methodology to collect and transfer ventilator data from the device to ZOLL to allow for a characterization of ventilator use in the pre -hospital setting. Data collected will be used to provide feedback, reporting, and benchmarking to individual agencies and departments on their ventilator use as well as aggregate use data from all ventilators to allow for comparisons. Objective: To collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre -hospital setting. Population: Cases where participating EMS Agencies use ZOLL 731 Series ventilator in accordance with device labeling and Agency protocols in a pre -hospital setting. Inclusion Criteria 1. Ventilated using ZOLL 731 Series ventilator with Release 5 (or greater) software 2. Data recorded in ventilator data file Exclusion Criteria None Study Sites: EMS Agencies using the 731 Series ventilator in the pre -hospital setting. Description of Intervention: Pre -hospital care providers including Emergency Medical Technicians (EMTs) and paramedics will provide ventilatory support with a ZOLL 731 Series ventilator in accordance with Agency protocols and procedures. Ventilator data (e.g. ventilator mode, tidal volume, ventilatory pressures, alarm events, etc.) will be downloaded from a ZOLL 731 Series ventilator RescueNet® VentReview software and uploaded to ZOLL's Clinical Trial Database. Limited information related to the event (e.g. reason for ventilator use, airway type, estimated IBW) will also be manually entered for review and characterization. Subject Participation Duration: No patient or outcomes follow-up is required for this study. Participation in this study will be complete once the patient is finally removed from the ventilator. No patient identifiers will be collected. DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC DocuSign Certificate Of Completion Envelope Id: 16FDDB2A78AE4A3997421C62F5A80A2D Subject: Complete with DocuSign: ZOLL Medical Clinical Trial Agreement_071223.pdf Source Envelope: Document Pages: 17 Signatures: 1 Certificate Pages: 5 Initials: 0 AutoNav: Enabled Envelopeld Stamping: Enabled Time Zone: (UTC-05:00) Eastern Time (US & Canada) Record Tracking Status: Original Holder: David Appleby 7/24/2023 10:12:50 AM dappleby@zoll.com Signer Events Signature David Appleby DocuSigned by: dappleby@zoll.com Eo-.1733B58AF28410...-/ 4ppl"�' Director, Clinical Affairs and Biostatistics ZOLL Security Level: Email, Account Authentication Signature Adoption: Pre -selected Style (None) Using IP Address: 67.218.11.44 Electronic Record and Signature Disclosure: Accepted: 2/4/2022 10:25:42 AM ID: 28be50d2-4149-4df8-a670-4fc37 b623af4 In Person Signer Events Signature Editor Delivery Events Status Agent Delivery Events Status Intermediary Delivery Events Status Certified Delivery Events Status Carbon Copy Events Status nathan burkhart COPIED nburkhart@zoll.com Cliniclat hte Security Level: Email, Account Authentication (None) Electronic Record and Signature Disclosure: Not Offered via DocuSign Witness Events Signature Notary Events Signature Envelope Summary Events Status Envelope Sent Hashed/Encrypted Certified Delivered Security Checked Signing Complete Security Checked Completed Security Checked Status: Completed Envelope Originator: David Appleby dappleby@zoll.com IP Address: 67.218.11.44 Location: DocuSign Timestamp Sent: 7/24/2023 10:14:08 AM Viewed: 7/24/2023 10:14:21 AM Signed: 7/24/2023 10:14:46 AM Timestamp Timestamp Timestamp Timestamp Timestamp Timestamp Sent: 7/24/2023 10:14:08 AM Viewed: 7/25/2023 10:22:58 AM Timestamp Timestamp Timestamps 7/24/2023 10:14:08 AM 7/24/2023 10:14:21 AM 7/24/2023 10:14:46 AM 7/24/2023 10:14:46 AM Payment Events Status Timestamps DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC Electronic Record and Signature Disclosure DocuSign Envelope ID: CA017F26-A20E-4482-A3DF-FC6607E622FC i:22 PM Parties agreed to: David Appleby ELECTRONIC RECORD AND SIGNATURE DISCLOSURE From time to time, Zoll Medical (we, us or Company) may be required by law to provide to you certain written notices or disclosures. 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