PRE-CLINICAL STUDY AGREEMENT

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					                              B&I PRE-CLINICAL AGREEMENT



THIS PRE-CLINICAL AGREEMENT, entered on the __ day of ________, 20__ is made by and
between ______, a ______ corporation (“Sponsor”), and Regents of the University of Minnesota
(“Institution”), a public educational institution and a Minnesota constitutional corporation
(together the “Parties”).

        In consideration of the mutual promises and covenants expressed herein the Parties agree
as follows:

1.0        TERM AND TERMINATION

        This Pre-Clinical Agreement is effective as of the date of last signature below and will
terminate upon execution by the Parties of a Clinical Study Agreement, or in the event the
Clinical Study Agreement is not executed, upon receipt by Institution of the payment set forth in
Paragraph 3.0.

2.0        PURPOSE

         The purpose of this Pre-Clinical Agreement is to ensure that Institution staff is
compensated for time and effort to evaluate the feasibility of undertaking participation in
Sponsor’s clinical study (“Clinical Study”), to review and submit the Clinical Study protocol,
investigator’s brochure and other material provided by Sponsor in preparation for the Clinical
Study, and to cover the costs for IRB review and approval. If the parties do not enter into a
Clinical Study Agreement, then payments made hereunder shall become consideration by the
Parties in full settlement and release of their obligations hereunder.

3.0        COMPENSATION

         Institution shall invoice Sponsor for $_____ for Institutional Review Board (IRB) fee and
$_____ in Study preparation fees and associated costs. Sponsor agrees to pay Institution within
thirty (30) days of invoice. If a Clinical Study Agreement is executed, these costs, if not
previously paid, will be incorporated into the Clinical Study Agreement and payment will be
subject to the terms and conditions of the Clinical Study Agreement. Payment under this Pre-
Clinical Study Agreement shall be made as follows:

Sponsor will pay by wire transfer to:

           Account Name: Regents of the University of Minnesota Sponsored Accounts Receivable
           Bank Name: Wells Fargo Bank, N.A.
           Bank Address: 6th & Marquette Ave, Minneapolis, MN 55417
           RTN/ABA: 121000248
           Account Number: 6504703643

           or by check, which will be made payable to Regents of the University of Minnesota and
sent to:

           Regents of the University of Minnesota
           NW 5957
       PO Box 1450
       Minneapolis, MN 55485-5957

4.0    MISCELLANEOUS

       4.01   The Parties agree to comply with all State, Federal and local laws and regulations
              regarding confidential information, medical information or protected health
              information.

       4.02   This Agreement may only be amended by mutual written agreement of the
              Parties.

       4.03   This Agreement may not be assigned without the other Parties express written
              consent.

       4.04   This Agreement may be signed in counterparts, each of which shall be
              deemed one and the same original. The parties agree that imaged or faxed
              signatures are valid, and shall constitute assent by the parties to each of the
              terms of the Agreement.


ACCEPTED AND AGREED:


SPONSOR:                                      REGENTS OF THE UNIVERSITY
                                              MINNESOTA
                                              By Sponsored Projects Administration:

By: ____________________________              By: ____________________________
Title:                                        Title:
Date:                                         Date:

Signature: _______________________            Signature: _______________________