ࡱ> m }dbjbj"" ;@;j@;jD\8$ $ 8TW\PA @@@@@@@.CE@bbb@ A###bF@#b@##Ng;8?PbB=0@ A0PA=PF F`??\F{?d#`@@! PAbbbbF$ Y }: CLINICAL TRIAL AGREEMENT INVESTIGATOR-INITIATED THIS Agreement is entered into on ____ by and between the Ģý (Institution), a not-for-profit educational institution established under the laws of New York State, with business offices located at 910 Genesee St., Suite 200 Rochester, NY 14611-3847 and _____________________ (Company), a _________ established under the laws of ____________, with offices located at ____________. RECITALS Whereas, Institution desires to study the safety and/or efficacy of [DRUG or DEVICE] (Study Drug) or (Study Device) and Company is willing to provide the Study Drug/Device; and Whereas, the Study (as defined below) is of mutual interest and benefit to Company and Institution, and will further the Institutions instructional and research objectives in a manner consistent with its status as a not-for-profit tax-exempt educational institution; Now therefore, in consideration of the promises and mutual covenants herein contained, Company and Institution hereby agree as follows: STATEMENT OF WORK. The Institution shall exercise reasonable efforts to carry out the clinical trial research study set forth in the research protocol developed by Institution dated ____ and entitled _____ (the Study), which is attached hereto as Exhibit A (the Protocol) and hereby incorporated into this Agreement by reference. The Study shall be conducted under the direction of [Investigator] Principal Investigator in accordance with this Agreement. In the event of any inconsistency between this Agreement and the Protocol, the terms of this Agreement shall govern. Changes in the Protocol may be made only through prior written agreement between the Company and the Institution. 2. PERIOD OF PERFORMANCE. The Period of Performance under this Agreement shall be (begin date) through (end date), unless extended by amendment of this Agreement or terminated in accordance with Article 14. The Study may not begin, and no patient shall be enrolled, until approval of the Study is received from the Institutions Institutional Review Board (IRB). 3. PAYMENT. (a) Company shall reimburse the Institution via ACH bank transfer for all direct and indirect costs incurred by Institution in accordance with the payment schedule attached hereto as Exhibit B and incorporated herein by reference (the Budget). Banking information will be provided at a later date. The parties estimate that the payments provided for in the Budget will be sufficient to support the Study, but Institution may submit to Company a revised budget requesting additional funds in the event that costs may reasonably be projected to exceed the Budget. Except as otherwise provided in this Agreement, Company will not be required to make any payment in excess of the Budget without Companys prior written approval. Regardless of whether it is included in the Budget, the Company understands and agrees that it is responsible for paying the Institutions nonrefundable Institutional Review Board fee, and shall pay such fee within thirty (30) days of the date of invoice except as otherwise provided in the Budget. 4. SUPPLIES. Company will provide Institution, at no charge, with a sufficient quantity of the Study Drug to conduct the Study, as well as any other compounds, materials, equipment, and information, which the Protocol specifies, or which Company deems necessary to conduct the Study. All such Study Drug , compounds, materials, and equipment remain the sole property of Company, unless otherwise designated. 5. INVESTIGATORS AND COMPANYS ASSURANCE. (a) The Study shall be conducted in accordance with the Study Protocol, Companys written instructions relating handling and storage of the Study Drug and all laws and regulations applicable to the performance of the Study. (b) Institution, Principal Investigator and Company shall comply with all applicable federal, state and local laws, regulations and guidelines including, but not limited to, the Federal Food, Drug and Cosmetic Act, as amended (the Act) and regulations promulgated thereunder and the United States Food and Drug Administration (FDA) regulations governing the protection of human subjects and regulations governing clinical investigators. (c) Company acknowledges that the responsibility to comply with and perform the provisions of 21 C.F.R. 312 subpart D and/or 21C.F.R. 812 Subpart C (Responsibility of Sponsors) rests with the Institution as required by FDA. (d) Institution certifies that neither Institution nor any person employed or engaged by Institution in the conduct of the Study has been debarred pursuant to Sections 306(a) or (b) of the Act and that no debarred person will in the future be employed or engaged by Institution in connection with conduct of the Study. Institution further certifies that it will notify Company immediately in the event of any debarment or threat of debarment of any person employed or engaged by Institution in the conduct of the Study occurring during the period of this Agreement. (e) In connection with research studies, Institution may collect Protected Health Information (PHI) as defined in 45 C.F.R. Section 164.501 or medical information on a patient as defined under New York State Public Health Law. Institution shall obtain a patient authorization/informed consent from study subjects to allow Institution to disclose the PHI and medical information to Company. Company shall use the PHI or medical information in accordance with the patient authorization/informed consent. If either party de-identifies PHI in accordance with the standards set forth in 45 C.F.R. Section 164.514, either party may use and disclose the de-identified information as permitted by law. 6. NOTICES. Any notices related to this Agreement or required herein shall be in writing and delivered by first class mail, postage prepaid, or by facsimile to the parties as follows: INSTITUTION COMPANY Anthony Beckman Interim Assoc VP for Research Administration Ģý Office of Research & Project Administration 5th Floor Hylan Bldg. Rochester, NY 14627 Phone: (585) 275-4031 FAX: (585) 275-9492 7. INDEPENDENT CONTRACTOR. The Institution is an independent contractor and not an agent, joint venturer, or partner of Company. INDEPENDENT RESEARCH. Nothing in this Agreement shall be construed to limit the freedom of the Principal Investigator and/or Institution, its employees and agents, whether paid under this Agreement or not, to engage in similar inquiries made independently under other grants, contracts or agreements with parties other than Company. 9. CONFIDENTIAL INFORMATION. All information designated at the time of disclosure, in writing, by either party as confidential (Confidential Information) shall not be used by the other party other than for purposes of this Agreement. Each party agrees to treat Confidential Information received from the other party with the same degree of care with which it would treat its own Confidential Information of a similar nature and further agrees not to disclose such Confidential Information to a third party without prior written consent of the other party, for a period of three (3) years following disclosure. The foregoing obligations of non-disclosure do not apply to Confidential Information which: is in the public domain at the time of disclosure or becomes publicly available through no fault of the recipient; was known to the other party prior to disclosure; was received from a third party not under an obligation of confidence to Company; is developed by the recipient without reference to the Confidential Information; or is required to be disclosed by law. Company acknowledges that Institution may need to provide study-related documents (for example, the study protocol) to a third party insurance company, if required by an insurance company for the purpose of obtaining a benefit coverage determination on behalf of a patient requesting coverage for participation in a clinical study. In addition, no Confidential Information involving individual patient data or medical records may be disclosed by either party at any time without appropriate patient authorization or consent as required by law. 10. DATA OWNERSHIP and INTELLECTUAL PROPERTY. Institution shall retain ownership of all completed case report forms and data generated as a result of the Study; however Company shall have the right to use all data and results generated during the course of the Study for any Study related purpose. Institution understands and acknowledges that the Study (Drug/Device) that is being provided to Institution for the purpose of conducting this Study is the property of Company and/or that the Study (Drug/Device) is subject to certain intellectual property rights owned by or licensed to Company. This Agreement shall not be deemed or construed to convey or transfer any rights with respect to the Study (Drug/Device) or with respect to any of such existing intellectual property rights to Institution except insofar as necessary to permit Institution to conduct the Study which is the subject of this Agreement. For all purposes herein, Institution Invention shall mean any discovery, improvement, concept or idea which arises out of work performed pursuant to the Study, including processes, methods, formulae, and techniques. Institution Inventions shall be the sole and exclusive property of Institution. Institution will disclose promptly to Company any and all Institution Inventions arising out of the work pursuant to the Study and give Company the first option to acquire an exclusive, worldwide, royalty-bearing license to the rights of Institution Invention. This option will expire six (6) months after the Institutions disclosure of the Institution Invention to the Company. 11. PUBLICATION. Company acknowledges that Institution is dedicated to the generation of new knowledge and information and to its public dissemination. Therefore, Institution shall have the right to publish material resulting from or related to the Study. The Institution shall furnish Company with a copy of any proposed written publication or presentation of such material at least thirty (30) days prior to the submission for publication or presentation. Company may review the publication or presentation to see if it contains patentable subject matter or other Company-owned confidential information that needs protection. Institution will, upon written request from Company within the thirty (30) day review period, delay the publication or presentation for a maximum of an addition sixty (60) days to allow Company or Institution to file a patent application or to remove the confidential information. Such Company required modification will not result in withholding any study results from academic publication. 12. SITE ACCESS. Either Company or FDA, as required by FDA regulations, shall have reasonable access to Principal Investigator and other project personnel, project facilities, drug records, subject records, case reports, and other records directly related to this Study, subject to applicable laws and regulations, during regular business hours and with reasonable prior notice. PUBLICITY. Neither party shall use the name of the other in connection with any products, promotion, or advertising related to this Study without the prior written permission of the other party. The foregoing shall not, however, preclude any legally required disclosure, reports generated in the normal course of business, or acknowledgement of sponsorship as required by an academic organization. TERMINATION. This Agreement may be terminated by either party for any reason upon thirty (30) days prior written notice to the other party. This Study may be terminated at any time for any reason by the Institution or Company when in their judgment or that of the Principal Investigator, the Institutions IRB, or the Food and Drug Administration it is determined to be inappropriate, impractical, or inadvisable to continue. The Institution shall be reimbursed for the reasonable costs of bringing this Study to termination incurred prior to termination and for non-cancelable commitments outstanding at that date. The Company shall receive a refund of any amounts paid prior to such termination in excess of amounts earned by the Institution as of the date of termination or notification of the decision to terminate, whichever is later. If a subject discontinues his or her participation or if the Study is discontinued for any reason, the Institution shall be held harmless and Company shall pay Institution on a prorated basis for such subjects or as otherwise set forth in payment schedule. All provisions of this Agreement that by their terms require performance by one or both parties following expiration or termination of this Agreement shall survive such expiration or termination. Such provisions shall include, but not be limited to, Articles, 3, 5, 6, 9, 10, 11, 12, 15, 17, 18, and 19. INDEMNIFICATION. (a) Company agrees to indemnify, protect, defend and hold harmless the University, its trustees, officers, employees and agents from any loss, damage, or liability they may suffer or incur as a result of claims or demands made against them that arise, directly or indirectly, from (i) Companys use of the Study results; (ii) negligence or willful misconduct on the part of the Company; (iii) a breach of applicable federal, state or local law by the Company or (iv) defects in the Companys product provided that the indemnified parties have utilized such product in accordance with the Protocol. Institution will promptly notify Company of any such claim and Company will cooperate in the defense of the claim. Company agrees, at its own expense, to provide attorneys reasonably acceptably to Institution to defend against any claim with respect to which the Company has agreed to provide indemnification hereunder. Company agrees not to settle any claim with an admission of liability against the Institution without the Institutions prior written consent. This indemnity shall not be deemed excess coverage to any insurance or self-insurance the Company may have covering a claim. (b) Institution hereby agrees to indemnify, defend and hold harmless Company, its respective agents, representatives, officers and employees (Indemnitees) from any liability, damage, loss or expense (including the reasonable attorneys fees and other costs and expenses of defense), by reason of personal injury or property damage which arises out of or connected with the gross negligence or intentional misconduct of Institution in performing the Study or the breach of any law or regulation applicable to Institution in the conduct of the Study (Claims), except to the extent that such liability is due to the negligence of Companys Indemnitees or breach of any law or regulation by Companys Indemnitees. Notwithstanding the above, Institution shall have no obligation to indemnify Sponsor for any other Claims (including, but not limited to, infringement or product liability Claims). The Company will promptly notify Institution of any such claim and will cooperate with the Institution in the defense of the claim. Institution agrees, at its own expense, to provide attorneys reasonably acceptably to Company to defend against any claim with respect to which the Institution has agreed to provide indemnification hereunder. Institution agrees not to settle any claim against Company with an admission of liability against the Company without Companys prior written consent. This indemnity shall not be deemed excess coverage to any insurance or self-insurance the Institution may have covering a claim. The provisions of this clause shall survive termination of this Agreement. INSURANCE. (a) Company shall, at its sole cost and expense, procure and maintain comprehensive liability, clinical trial and product liability insurance in amounts not less than $3,000,000 per incident . Such liability insurance shall include Institution and its trustees, directors, employees and agents as additional insureds with respect to this Agreement. If Companys insurance is written on a claims made basis as opposed to an occurrence basis, Company shall purchase tail coverage and/or a retrospective coverage provision to provide continuation and uninterruption of coverage of all claims. Companys insurance will be primary coverage with respect to its indemnification obligations hereunder and Institutions insurance or self-insurance will be excess and noncontributory. Upon request, Company shall provide Institution with written evidence of such insurance prior to commencement of the Study. Company shall provide Institution with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance; if Company does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, Institution shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice of any additional waiting periods. Institution shall maintain Workers Compensation insurance or other coverage on its employees as required by New York law and will self-insure or maintain insurance covering its liability under this Agreement. Company and Institution hereby waive any rights of subrogation. COMPLIANCE WITH HIPAA. It is understood and agreed that Institution, as a covered entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), may not use or disclose protected health information (PHI), as defined in HIPAA and its implementing regulations, for purposes other than treatment, payment, or health care operations without first obtaining authorization from the individual concerned. Institution agrees to obtain authorization from individuals enrolled in the Study which permits disclosure to and use of PHI by Company for purposes of conducting and overseeing the trial. Company agrees that it shall not disclose PHI to any person or entity except as permitted by the HIPAA authorization 18. COMMUNICATION CONCERNING CERTAIN EVENTS AFFECTING RESEARCH SUBJECTS. During and for a period of at least two years or upon completion of data analysis after the completion of the study, Sponsor shall promptly report to the Principal Investigator any information that could directly affect the health or safety of past or current study participants or influence the conduct of the study, including but not limited to the study results and information in site monitoring reports and data safety monitoring committee reports as required by the protocol. In each case, the investigator and the Institution shall be free to communicate these findings to each study participant and the IRB. 19. NO WARRANTIES. THE INSTITUTION MAKES NO WARRANTIES, EXPRESS, OR IMPLIED, CONCERNING ANY MATTER WHATSOEVER, INCLUDING WITHOUT LIMITATION, THE RESULTS OF THIS STUDY OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF SUCH RESULTS. The Institution shall not be liable for any indirect, consequential, or other damages suffered by Company or any other entity or individual including, but not limited to, damages arising from loss of data or delay or termination of the Study or from the use of the results of the Study or any invention or product resulting from the Study. 20. NO WAIVER. The waiver of any breach or default hereunder by either party shall not operate or be construed as a waiver of any repetition of such breach or default or of any other breach or default. 21. DISPUTES. If a dispute arises out of or relates to this Agreement, or breach thereof, the parties agree first to try in good faith to settle the dispute by negotiation, before resorting to arbitration, litigation, or some other dispute resolution procedure. The forum for such proceedings will be Monroe County, New York. 22. ENTIRE AGREEMENT. This Agreement describes the entire agreement between the parties concerning the subject matter hereof and supersedes all prior or contemporaneous agreements, representations or understandings, written or oral. This Agreement controls over any inconsistent agreement between Company and Principal Investigator, and may not be amended, changed or modified except in a writing signed by both parties hereto. 23. ASSIGNMENT. Neither party may assign this Agreement without the prior written consent of the other party; provided, however, that Company may assign this Agreement to a successor in ownership of at least 51% of its assets, provided that such successor expressly assumes, in writing, the obligation to perform in accordance with the terms and conditions of this Agreement. Any attempt by either party to assign this Agreement without such consent shall be void. 24. COUNTERPARTS. This agreement may be executed and delivered in one or more counterparts, which when executed and delivered shall be deemed to be an original but all of which when taken together shall constitute one and the same Agreement. A facsimile transmission or PDF file of this signed Agreement bearing a signature on behalf of a party shall be legal and binding on such party; however, this shall not preclude either party from requiring the exchange of original signatures. 25. SEVERABILITY. If any provision of this Agreement shall be or become invalid under any provision of federal, state or local law, or by a court of competent jurisdiction, such invalidity shall have no effect on the validity or enforceability of the remaining provisions of this Agreement, and they shall continue in full force and effect. If such deletion substantially alters the basis of this Agreement, the parties will negotiate in good faith to amend the Agreement to give effect to the original intent of the parties. 26. GOVERNING LAW. This Agreement shall be interpreted in accordance with, and governed by, the laws of the State of New York, without regard to its conflict of laws rules, and irrespective of the domicile or residence of the parties or of the location of any property affected hereby. The venue for any action to interpret or enforce this Agreement shall be in Monroe County, New York. 27. [include only for Cancer Center Clinical Trials] DATA MANAGEMENT. Company acknowledges that Institution has implemented an electronic regulatory record management system to create, store and maintain all regulatory documentation and Institution intends to use such system to prepare and maintain all records which are required in connection with the conduct of the Study; and Company agrees that it will utilize such system to obtain access to and/or audit any such records. IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate by proper persons thereunto duly authorized. COMPANY UNIVERSITY OF ROCHESTER By: By: Name: Name: _________________________ Title: Title: ___________________________ Date: Date: Read and Acknowledged: I have read the foregoing and, while not a party to this Agreement, I understand and agree to comply with the obligations of the Principal Investigator as stated herein. By: PRINCIPAL INVESTIGATOR Name: Date:     Page  PAGE 1 Rev 3.26.25 OGC/JP/BGK 01g   9 : ? 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Aptos Display3. AptosA$BCambria Math"hgg4,"g N/ N/!20\\3Q@P ?k2!xx0 CLINICAL TRIAL AGREEMENTDonna J. SenatorKavanaugh, Brenda (ORPA)`                Oh+'0 $0 P \ h tCLINICAL TRIAL AGREEMENTDonna J. SenatorNormalKavanaugh, Brenda (ORPA)5Microsoft Office Word@ @."@}^@#a N ՜.+,0 hp   Microsoft/\ CLINICAL TRIAL AGREEMENT Title  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHJKLMNOPRSTUVWXYZ[\]^_`abcdefghijklmnopqrstvwxyz{|~Root Entry FPjb@Data I1TableQFWordDocument ;SummaryInformation(uDocumentSummaryInformation8}MsoDataStorePbPb5EUE4YCGAQ==2PbPbItem  PropertiesUCompObj r   F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q