Research Project Agreement by rqn10235


More Info
									                                         RESEARCH AGREEMENT

THIS AGREEMENT is made by and between _____________________________________ (hereinafter referred to
as "SPONSOR"), and THE UNIVERSITY OF TENNESSEE, an educational corporation of the State of Tennessee
(hereinafter referred to as the "UNIVERSITY").


Whereas, the research project contemplated by this Agreement is of mutual interest and benefit to the SPONSOR
and the UNIVERSITY, and will further the instructional and research objectives of the UNIVERSITY in a manner
consistent with its status as an educational corporate agency of the State of Tennessee.

Now, therefore, in consideration of the mutual covenants contained herein, the parties hereto agree as follows:

1. STATEMENT OF WORK. The UNIVERSITY agrees to use reasonable efforts to perform the research project
entitled, "______________________________________," under the direction of ______________________
("Principal Investigator"). The UNIVERSITY shall provide personnel, facilities, and resources as required to
accomplish the work necessary to complete the project.

(Note: Add specific work to be performed or refer to protocol attached.)

2. PERIOD OF PERFORMANCE. The period for the performance of work shall be from
 ____________________ through ____________________, but may be extended by written notification from

3. PAYMENT. Total cost to the SPONSOR shall not exceed $_____________. Payment shall be made to the
UNIVERSITY by the SPONSOR according to the following schedule, which includes an initial payment
of_______________ in advance:

(Note: insert schedule of payments).

Checks shall be made payable to the University of Tennessee (Tax ID # 1-626-001636-W), should reference the PI's
name, and shall be mailed to the following address:

                  Anthony A. Ferrara
                  Vice Chancellor for Finance and Operations
                  University of Tennessee Health Science Center
                  62 S. Dunlap
                  Memphis, Tennessee 38163

This contract is considered to be a fixed-fee agreement. Issuance of final payment to the UNIVERSITY shall
release the UNIVERSITY from further obligation with regard to the conduct of the study.

conduct of a research project may require the transfer of proprietary information between the parties. Accordingly,
it is agreed that each party shall retain in confidence the proprietary information of the other party and shall not
disclose such information to any other person, nor use such information, without the written permission of the other
party, except in accordance with the terms of this Agreement.
ORA-004 1/28/2011

         a. The term "proprietary information" as used herein, in the case of documentary information, shall include
only that documentary information which is clearly marked as proprietary and export-controlled, if applicable, at the
time when it is given to the receiving party. "Proprietary information" which is originally orally disclosed shall
include only that information which is identified as being proprietary by written communication sent within a
reasonably prompt period of time after it is disclosed.

         b. The term "proprietary information" as used herein shall not include any information which the recipient
clearly shows by appropriate documentation:

         (1) Was at the time of receipt both legally and independently known to the receiving party, its agents, or

         (2) Without breach of this Agreement by the receiving party has been published or is
         otherwise within the public knowledge or is generally known to the public at the time
         of disclosure;

         (3) Is received from a third party without restrictions regarding disclosure, unless the
         receiving party has actual knowledge that such third party is not authorized to disclose
         such information without restriction;

         (4) Becomes a part of the public domain after disclosure without breach of this
         Agreement by the receiving party;

         (5) Subsequent to disclosure is independently developed by agent(s) or employee(s)
         of the receiving party without knowledge of the disclosure;

         (6) Has been in the possession of the receiving party longer than three (3) years;

         (7) Is required by law, including the Tennessee Public Records Act, to be disclosed; or

         (8) Is required to be disclosed if necessary for defense of the receiving party in any suit or claim brought as
         a result of the study.

5. PUBLICATION. The UNIVERSITY may publish the results of scientific investigations involving this study,
provided that confidential and/or proprietary information of the SPONSOR not publicly known is not disclosed and
that the SPONSOR is provided a copy of the manuscript thirty days prior to submission for publication so that it
may offer comments thereon. SPONSOR shall have the right to delay publication for a period not to exceed ninety
(90) days after receipt of such manuscript to allow time for filing any appropriate patent applications. Should
SPONSOR fail to make a written request for delay in publication within thirty (30) days after receipt of any
manuscript from the UNIVERSITY, the UNIVERSITY shall be free to publish the manuscript as submitted and
UNIVERSITY shall incur no liability to SPONSOR thereafter.

6. INDEPENDENT CONTRACTOR. The UNIVERSITY's relationship to the SPONSOR in the performance of
this Agreement is that of an independent contractor.

7. INDEMNIFICATION. THE SPONSOR shall hold harmless and indemnify any and all of UNIVERSITY, its
agents, officers, employees, students, and professional staff from and against any and all claims and suits arising out
of this study or any act or omission of the SPONSOR involving the manufacture or distribution of any product
involved with this Agreement, provided such injury is not the result of negligence or improper action or omissions
on the part of the indemnitee. The indemnification shall include but not be limited to reimbursement of all costs,
ORA-004 1/28/2011

including attorney fees, incurred in the defense of the claim or suit and any judgment or settlement. It is understood
that the administration of any substance provided for in the protocol shall not constitute negligence or malpractice
for the purposes of this Agreement.

is self-insured under the provisions of the Tennessee Claims Commission Act (T.C.A. 9-8-301 et seq.), and its
liability to SPONSOR and to third parties for the negligence of the UNIVERSITY and its employees is subject to
the tort provisions of that Act. Accordingly, any liability of the UNIVERSITY for any damages, losses, or costs
arising out of or related to acts performed by the UNIVERSITY or its employees under this agreement is governed
by the provisions of said Act.

Notwithstanding anything in this agreement to the contrary, any provisions or provisions of this agreement will not
apply to the extent that it is (they are) finally determined by a court of competent jurisdiction, including appellate
review if pursued, to violate the laws or Constitution of the State of Tennessee.

efforts to perform the research as set forth in Section 1 (Statement of Work), the UNIVERSITY makes no
warranties, either express or implied, as to the results of such research or the merchantability or fitness for a
particular purpose of the research. The UNIVERSITY shall not be liable for any direct, consequential, or other
damages suffered by the SPONSOR or others resulting from the use of the research.

10. KEY PERSONNEL. ______________________________, Principal Investigator, is considered to be essential
to the work performed under this contract. Substitutions for the Principal Investigator or substantial changes in
his/her level of efforts will not be made without the prior written approval of SPONSOR.

11. PRE-EXISTING INTELLECTUAL PROPERTY OF THE PARTIES. Neither party claims by virtue of this
Agreement any right, title, or interest in (a) any issued or pending patents owned or controlled by the other party or
(b) any invention, process, or product arising out of the other party's previous research or development, whether or
not patentable.

12. USE OF PARTIES' NAMES. Neither party to the Agreement shall use the name of the other party in any form
of publicity without the written permission of that party.

13. TERMINATION. Performance under this agreement may be terminated by either party upon sixty (60) days'
written notice. Upon termination, the SPONSOR shall reimburse the UNIVERSITY for all costs and
non-cancellable commitments incurred in the performance of the research, such reimbursement not to exceed the
total estimated project costs specified in Section 3.

14. MODIFICATION. This agreement constitutes the sole, full, and complete agreement by and between the
parties with regard to the subject of this Agreement; and no amendments, changes, additions, deletions, or
modifications to or of this Agreement shall be valid unless reduced to writing, signed by the parties, and attached

15. NOTICES AND OTHER COMMUNICATIONS. With the exception of research funds paid by SPONSOR
under the provisions of Section 3, all notices and other communications between the parties shall be deemed
sufficiently given when hand-delivered or sent by prepaid United States mail or other recognized carrier, addressed
as follows:

ORA-004 1/28/2011

         a. If to SPONSOR:                            (NOTE: Insert name, title, and address
                                                      of SPONSOR"s authorized representative).

         b. If to UNIVERSITY:                         Office of Research Administration
                                                      910 Madison, Suite 823
                                                      Memphis, TN 38163

         With copy to:                                (Note: Insert name and address of PI).

16. EXPORT CONTROL. SPONSOR acknowledges that the export of goods and/or technical data from the
United States may require some form of export control license from the U.S. Government. SPONSOR agrees that it
will not disclose, export or re-export any materials or technical data received under this Agreement to any countries
for which the U.S. Government requires an export license, unless the SPONSOR has obtained prior written
authorization first from the U.S agency or authority responsible for such matters. SPONSOR agrees that it is
responsible for any fees or expenses associated with obtaining an Export License, if required. UNIVERSITY
neither represents that a license shall not be required nor that, if required, it shall be issued.

17. HIPAA Compliance. SPONSOR warrants to the UNIVERSITY 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. SPONSOR warrants that it will
cooperate with the UNIVERSITY in the course of performance of the Agreement so that both parties will be in
compliance with HIPAA, including cooperation and coordination with UNIVERSITY privacy officials and other
compliance officers required by HIPAA and its regulations. SPONSOR will sign any documents that are reasonably
necessary to keep the UNIVERSITY and SPONSOR in compliance with HIPAA, including but not limited to
business associate agreements. SPONSOR agrees to use any Private Health Information (as defined by HIPAA)
made available to it only as authorized by the subjects on an approved informed consent form and/or authorization
and to require the same of any affiliates or agents with whom PHI may be shared.
18. SPONSOR agrees with it shall comply fully with all applicable requirements relating to the timely registration
of clinical trials set forth in Title VIII of the Food and Drug Administration Amendments Act of 2007 (Public Law
110-85). Specifically, SPONSOR agrees that it is the “responsible party” as that term is defined in
§801(a)(2)(j)(1)(A)(ix) of the Act and that the Study is an “applicable clinical trial” as that term is defined in
§801(a)(2)(j)(1)(A)(i) thereof.

19. GOVERNING LAW. This Agreement shall be governed by and construed in accordance with the laws of the
State of Tennessee.

THIS AGREEMENT shall not be considered accepted, approved, or otherwise effective until the signature of each
party is affixed in the space provided below.

ORA-004 1/28/2011

IN WITNESS HEREOF, signifying their acceptance of and agreement to be bound by the terms and conditions of
this Agreement, the signatures of the parties are affixed hereto:

For (Name of SPONSOR):                            For THE UNIVERSITY OF TENNESSEE:

______________________________                    ___________________________________
(Signature)                                       (Signature)

______________________________                    Leonard R. Johnson, Ph.D.
(Typed Name)                                      Vice Chancellor for Research

Title: _________________________
Date: _________________________                   Date: ______________________________

ORA-004 1/28/2011


To top