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: THE UNIVERSITY OF TENNESSEE
CONTRACT
This Contract, made and entered into as of the latest of the signature dates as indicated on the signature page, documents the agreement between The University of Tennessee, with offices at 62 S. Dunlap, Suite 300, Memphis, Tennessee 38163 (hereinafter University) and the Chattanooga-Hamilton County Hospital Authority d/b/a Erlanger Health System, with offices at 975 East Third Street, Chattanooga, Tennessee 37403 (hereinafter Contractor).
This Contract consists of this cover page, the attached Terms and Conditions and all other attachments applicable to a particular study.
Contractor will provide the following: Serve as study site for [inser Study name] (the Study) sponsored by [insert who the Sponsor is] (the Sponsor) contingent upon (i) approval of the applicable Institutional Review Board and (ii) execution of all other applicable documents, including but not limited to a Clinical Research Agreement between the University and the Sponsor and a Study Site Agreement between Contractor and Sponsor.
The period of performance under this contract is from ________________ to ______________. However, either party may terminate this contract by giving the other at least thirty (30) days written notice before the effective termination date; provided, however, the University shall no longer conduct the Study at any of the Contractors facilities following the effective termination date.
The Universitys maximum liability under this contract is $___________
The following costs will be reimbursed to Erlanger as follows:
No other payments will be made for patient care costs for any reason.
In witness of their acceptance of the terms of this agreement, the parties have had this Contract executed by their duly authorized representatives.
FOR CONTRACTOR: FOR UNIVERSITY:
________________________________ __________________________________
Signature Signature
S. Lynn Whisman SVP/CNO __________________________________
Name (Printed) Name (Printed)
Title
________________________________ __________________________________
Date Date
62-6000101 SSN or Federal ID No.
TERMS AND CONDITIONS
Neither party is bound by this Contract until it is approved by the appropriate official(s) for each indicated on the signature page of this Contract.
This Contract may be modified only by a written amendment which has been executed and approved by the appropriate parties as indicated on the signature page of this Contract.
Neither party may assign this Contract or enter into a subcontract for any of the services performed under this Contract without obtaining the prior written approval of the other.
Unless otherwise indicated on the reverse, if this Contract provides for reimbursement for travel, meals or lodging, such reimbursement must be made in accordance with University travel policies.
The Contractor warrants that no part of the total Contract amount shall be paid directly or indirectly to an employee or official of the State of Tennessee as wages, compensation, or gifts in exchange for acting as officer, agent, employee, subcontractor, or consultant to Contractor in connection with any work contemplated or performed relative to this Contract, and that no employee or official of the State of Tennessee holds a controlling interest in the Contractor. If the Contractor is an individual, the Contractor certifies that he/she is not presently employed by the University or any other agency or institution of the State of Tennessee; that he/she has not retired from or terminated such employment within the past six months; and that he/she will not be so employed during the term of this Contract.
Each party shall maintain documentation for all charges against the University under this Contract. The books, records and documents, insofar as they relate to work performed or money received under this Contract, shall be maintained for a period of four (4) full years from the date of the final payment, and shall be subject to audit, at any reasonable time and upon reasonable notice, by the other party or the Comptroller of the Treasury, or their duly appointed representatives. These records shall be maintained in accordance with generally accepted accounting principles.
No person on the grounds of disability, age, race, color, religion, sex, national origin, veteran status or any other classification protected by Federal and/or Tennessee State constitutional and/or statutory law shall be excluded from participation in, or be denied benefits of, or be otherwise subjected to discrimination in the performance of this Contract. Each party shall, upon request, show proof of such non-discrimination, and shall post in conspicuous places, available to all employees and applicants, notice of nondiscrimination.
Compliance with Law. Both parties shall comply with all applicable Federal, state and local laws, regulations and orders in the performance of this Contract, including but not limited to the Ethics in Patient Referrals Act, 42 U.S.C. 1395nn and accompanying regulations (42 CFR Part 411), more commonly known as the Stark Law, and the Medicare and Medicaid Anti Fraud and Abuse Law, 42 U.S.C. 1320a 7b, more commonly known as the Anti-Kickback Law. In addition, University agrees to abide by, and shall require the Principal Investigator for a Study to abide by, Authoritys Code of Conduct found on the Internet at HYPERLINK "http://www.erlanger.org/workfiles/CodeOfConduct[1].011906.pdf" http://www.erlanger.org/workfiles/CodeOfConduct[1].011906.pdf, the Authoritys Compliance with the Anti-Kickback Statute and Stark Law Policy, found on the Internet at HYPERLINK "http://www.erlanger.org/workfiles/StarkAnti_Kickback%20Policy.Adm.980.NEW.09212010.doc.pdf" http://www.erlanger.org/workfiles/StarkAnti_Kickback%20Policy.Adm.980.NEW.09212010.doc.pdf , and Authoritys Corporate Compliance Program, found on the Internet at HYPERLINK "http://www.erlanger.org/workfiles/EHS%20Compliance%20Program%20Plan-2011.pdf" http://www.erlanger.org/workfiles/EHS%20Compliance%20Program%20Plan-2011.pdf , including participation in any relevant compliance training as requested by the Authority.
Unlawful Remuneration. Contractor will not, under this Contract, provide any unlawful remuneration or benefit to any physician or source of referrals to Contractor and/or any of its facilities. The parties will adopt such procedures as they deem appropriate to implement the purposes of this section.
Sunshine Law and Public Records Act. University knows and understands that the Contractor is a Tennessee governmental entity, and as such the meetings of its Board are subject to the Tennessee Open Meetings Act and the Contractor is subject to the Tennessee Public Records Act. Accordingly, and notwithstanding any provision in this Contract to the contrary, University agrees that any actions taken by Contractor pursuant to these laws shall not constitute a breach of this Contract by the Contractor.
This Contract shall be governed by the laws of the State of Tennessee, which provide that the University has liability coverage solely under the terms and limits of the Tennessee Claims Commission Act, which covers certain tort liability for actual damages of up to Three Hundred Thousand Dollars ($300,000) per claimant and One Million Dollars ($1,000,000) per occurrence.
Notwithstanding any provision of this Contract to the contrary, any liability of the Authority under this Contract shall be limited to the coverages, amounts and procedural requirements of the Tennessee Governmental Tort Liability Act, and any other local, state, or federal law or regulation limiting the liability of Authority or its trustees, officers, employees or agents, and this liability is expressly subject to the provisions of such laws, as such now exist or may be hereafter amended, revised or interpreted.
The Contractor shall avoid at all times any conflict of interests between its duties and responsibilities as a Contractor and its interests outside the scope of any current or future Contracts. The following principles define the general parameters of a conflict of interests prohibited by the University:
A Contractors outside interests shall not interfere with or compromise its judgment and objectivity with respect to its duties and responsibilities to the University.
A Contractor shall not make or influence University decisions or use University resources in a manner that results in:
Financial gain outside any current or future Contracts for either the Contractor, its principal(s) or any of their relatives or
Unfair advantage to or favored treatment for a third party outside the University.
A Contractors outside financial interests shall not affect the design, conduct, or reporting of research.
If either party fails to perform properly its obligations under this Contract or violates any term of this Contract, the other shall notify breaching party by written notice of the alleged breach, and the breaching party shall thereafter have thirty (30) days to cure such breach. If the breaching party fails to cure such breach, the non-breaching party shall have the right to terminate this Contract immediately and withhold payments in excess of fair compensation for completed services. The breaching party shall not be relieved of liability to the other for damages sustained by breach of this Contract.
For personal, professional, and consultant services, the Contractor shall submit brief, periodic progress reports to the University as requested.
In compliance with the requirements of Chapter 878, Public Acts of 2006 of the State of Tennessee, for any contract for goods or services purchased by the University, the Contractor hereby attests that the Contractor shall not knowingly utilize the services of an illegal immigrant in the performances of this Contract and shall not knowingly utilize the services of any subcontractor who will utilize the services of an illegal immigrant in the United States in the performance of the Contract.
Confidentiality of Records. Each party shall reasonably inform its employees, agents and services of the necessity of confidentiality of information or data acquired or generated through studies subject to this Agreement. Strict standards of confidentiality of records and information shall be maintained in accordance with applicable state and federal law. All material and information, regardless of form, medium or method of communication, provided to the each party by the other or acquired by the each party on behalf of the other shall be regarded as confidential information in accordance with the provisions of applicable state and federal law, state and federal rules and regulations, departmental policy, and ethical standards. Such confidential information shall not be disclosed to any third party, and all necessary steps shall be taken by each party to safeguard the confidentiality of such material or information in conformance with applicable state and federal law, state and federal rules and regulations, departmental policy, and ethical standards.
The parties obligations under this section do not apply to information in the public domain; entering the public domain but not from a breach by a party to this Contract; previously possessed by that party without written obligations to the other to protect it; acquired by a party without written restrictions against disclosure from a third party which, to the partys knowledge, is free to disclose the information; the party can prove by written documentation was independently developed by the party without the use of the others information; or, disclosed by the party to others without restrictions against disclosure. The parties obligations do not apply to information that is required by applicable law (including the Tennessee Public Records Act) to be disclosed.
Nothing in this paragraph shall permit either party to disclose any information that is confidential under federal or state law or regulations, regardless of whether it has been disclosed or made available to the party due to intentional or negligent actions or inactions of agents of the other or third parties.
.
HIPAA Compliance. Each party represents to the other that it is familiar with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its accompanying regulations, and will comply with all applicable HIPAA requirements in the course of this contract. Each party represents that it will cooperate with the other in the course of performance of the contract so that both parties will be in compliance with HIPAA, including cooperation and coordination with the respective privacy officials and other compliance officers of each party required by HIPAA and its regulations. Each party will sign any documents that are reasonably necessary to keep the University and Contractor in compliance with HIPAA, including but not limited to business associate agreements. Both parties agree to use and disclose any protected health information (PHI) solely consistent with the consent form/authorization.
Data Ownership. Contractor shall make no claim to data or intellectual property arising under this Agreement; all such data shall be owned by University or such other entity as University shall determine.
Access to Records. Each party agrees to allow the other and the study sponsor/funding agency and regulatory agencies access to relevant medical records generated under this Agreement, subject to applicable laws.
Contractor Employees and Agents. Each party shall require that its employees and agents who provide services hereunder or who have access to information or data acquired or generated hereunder are bound by the provisions of this Agreement.
Third Party Payer. The Contractor will not seek reimbursement from any federal healthcare program or third party payer for any amounts paid by University that are being reimbursed as study related services.
Debarment Certification. Each party certifies that it is not and does not use in any capacity the services of any person debarred under the Generic Drug Enforcement Act of 1992, subsections 306(a) or 306(b); or any testing facility disqualified under CFR Part 58, Subpart K, or a clinical investigator disqualified under 21 CFR 312.70, in connection with any of the services performed by Contractor pursuant to this Agreement. Each party agrees that it will immediately disclose in writing to other if it becomes aware of any person, testing facility or clinical investigator engaged in the performance of services under this agreement is disqualified or debarred, or if any action, suit, claim, investigator or legal or administrative proceeding is pending or threatened, relating to the debarment or disqualification of the party or any person performing services hereunder.
Each party represents and certifies that it has never been sanctioned by or excluded from participation in the Medicare, Medicaid, or any other state or federal healthcare program for program-related offenses and has never been convicted of a criminal offense related to health care. Each party shall notify the other immediately if any such action is officially proposed or taken against it, or if it becomes the subject of an investigation that could lead to such action, at which time the other party may terminate this Contract.
It is expressly understood and agreed that the obligations set forth in this section shall survive the termination of this Contract.
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