This AGREEMENT is entered into by and between _________________________, hereinafter called SPONSOR, and the Board of Regents of the University of Wisconsin System, hereinafter called UNIVERSITY. In anticipation of benefits to each party, SPONSOR and UNIVERSITY agree as follows: 1. SCOPE OF WORK The UNIVERSITY will perform the project set forth in the appended PROTOCOL. Any additional work not identified in the approved PROTOCOL, but indicated during the course of the study, will be separately negotiated and funded in appropriate amounts to be agreed upon by SPONSOR and UNIVERSITY. 2. PERIOD OF PERFORMANCE The project will be conducted during the period ____________________ through __________________, and may be extended by mutual agreement of the parties. 3. PAYMENTS In consideration for performance under terms of this AGREEMENT, SPONSOR agrees to pay UNIVERSITY $_______________________ per patient studied, in accordance with the appended BUDGET. Check(s), payable to the University of Wisconsin, shall be sent to: Principal Investigator Principal Investigator Address University of Wisconsin Madison, WI For identification purposes, each payment shall include the title of the project and the name of the Principal Investigator. Payments shall be made according to the following schedule: 4. PROJECT DIRECTION The project will be directed by ____________________________ who will be accountable to the UNIVERSITY as Principal Investigator of the project. A change of Principal Investigator will require UNIVERSITY and SPONSOR agreement in writing. 5. INDEPENDENT CONTRACTOR The UNIVERSITY will perform the project as an independent contractor. Employees of the UNIVERSITY will not be considered employees of the SPONSOR for any purpose. 6. NOTICES All notices to either party by the other regarding this AGREEMENT shall be delivered personally, or sent by registered mail to the individuals identified below: UNIVERSITY: Research and Sponsored Programs 750 University Avenue Madison, Wisconsin 53706 SPONSOR: 7. PROPRIETARY INFORMATION Unless otherwise required by law, the UNIVERSITY will exercise its best effort to maintain in confidence proprietary or trade secret information disclosed or submitted to UNIVERSITY by SPONSOR which is designated in writing as confidential information at the time of disclosure. Confidential information does not include information which at the time of receipt: (a) Is generally available in the public domain or thereafter becomes available to the public through no act of the UNIVERSITY; or (b) Was independently known prior to receipt thereof or was discovered independently by an employee of the UNIVERSITY who had no access to the information supplied by SPONSOR under this AGREEMENT; or (c) Was made available to the UNIVERSITY as a matter of lawful right by a third party. The UNIVERSITY retains the right to refuse to accept any such information which is not considered to be essential to the completion of the project. The obligations of the UNIVERSITY under this paragraph shall survive and continue for one year after termination of this AGREEMENT. 8. PUBLICATION The UNIVERSITY and its employees have an obligation to assure that research results are made known to the general public when in the opinion of the researcher and the UNIVERSITY it is appropriate to do so. The UNIVERSITY will provide a thirty (30) day review period prior to publication to afford the SPONSOR the opportunity to identify and prevent disclosure of any proprietary information that may have been inadvertently included in a proposed release. 9. PATENTS and INVENTIONS Except as required under 35 USE 200-212 or other cases where there is a co-mingling of funds which require assignment to the UNIVERSITY because of statutory or contracted obligations to a third party, and subject to a right reserved to the Board of Regents of the University of Wisconsin System to make and use any such invention, discoveries, and know-how for educational or research purposes, the UNIVERSITY warrants that it shall retain no ownership over any invention, patentable or otherwise, discoveries, know-how, patents or patent application in such inventions which are made during and as a part of the project being funded under this AGREEMENT. Such ownership rights shall remain the exclusive property of the inventor(s) who is under no obligation to assign said rights to the UNIVERSITY, except as set forth above. The SPONSOR may negotiate a separate agreement with the inventor(s) and/or the Wisconsin Alumni Research Foundation (WARF) with regard to access to any existing patents and the disposition of inventions made during and as a part of this project. 10. LIABILITY The UNIVERSITY agrees to provide liability protection for its officers, employees and agents while acting within the scope of their employment. The UNIVERSITY further agrees to hold harmless SPONSOR, its officers, agents and employees from any and all liability including claims, demands, losses, costs, damages and expenses of every kind and description (including death), or damages to persons or property arising out of or in connection with or occurring during the course of this agreement where such liability is founded upon or grows out of the acts or omissions of any of the officers, employees or agents of the UNIVERSITY. The UNIVERSITY as an agency of the State of Wisconsin cannot, without express legislative authorization, enter into a contractual indemnification agreement. 11. PUBLICITY The SPONSOR shall not use the name of the UNIVERSITY nor of any member of the University's staff in connection with any products, promotion, or advertising without the prior written approval of the UNIVERSITY. 12. TERMINATION This AGREEMENT may be terminated by either party at any time prior to its full term of performance provided that a written notice is given to the other party thirty (30) days in advance. In the event of termination by the SPONSOR, the UNIVERSITY will be reimbursed for all non-cancellable costs and commitments incurred in performance of the study through the effective date of the termination. 13. MISCELLANEOUS This AGREEMENT is the entire understanding between the parties relative to this project. This AGREEMENT may be changed only by written modification signed by both parties. APPROVED FOR THE SPONSOR: _____________________________________________ _____________________ BY DATE _____________________________________________ (NAME AND TITLE) APPROVED FOR THE UNIVERSITY: _____________________________________________ _____________________ BY DATE _____________________________________________ (NAME AND TITLE) CONCURRENCE BY THE PRINCIPAL INVESTIGATOR: _____________________________________________ _____________________ BY DATE This Clinical Trial Agreement shall take precedence over any conflicting administrative language contained in the protocol.