Guidelines for Grant and Contract Management
302A. Memorandum of Agreement for Clinical Studies
Whereas, 1 (type name of company) (the "Company") and The University of Chicago (the "University") have agreed that the Company will support the conduct of a study by the University of a drug identified in the protocol named herein, and the University has the personnel and facilities to undertake such a study. Now, Therefore, the parties agree as follows:
ARTICLE 1.
SCOPE OF WORK: The University, in a study under the direction of 2
(type name of the p.i.), M.D. (the "Principal Investigator"),
shall exercise its best efforts to carry out the program described in the
protocol entitled 3 "(type the name of the protocol)",
(the "Protocol") dated 4 (type a date), incorporated into
this Agreement by reference.
ARTICLE 2.
PERIOD OF PERFORMANCE: The proposed study shall commence on or about
5 (type a starting date), and is estimated to be completed on or
about 6 (type an ending date).
ARTICLE 3.
CONSIDERATION: The sum of 7 (type a dollar amount) is authorized
as the maximum compensation to be paid to the University under this Agreement.
This amount will be earned by the University based on 8 (type a dollar
amount) per completed case report form delivered to the Company for a
maximum of 9 (type no. of patients) subjects. However, if for any
reason a subject is dropped before completing the study, the Company will
reimburse the University for actual costs incurred in connection with that
subject.
ARTICLE 4.
PAYMENTS: The Company will pay 10 (type a dollar amount) advance
funding upon execution of this Agreement, and will make additional payments
as follows:
11
($ type dollar amount requirements)
($ type dollar amount requirements)
Checks should be made payable to The University of Chicago and directed to:
Restricted Funds
Office of the Comptroller
The University of Chicago
1225 East 60th Street
Chicago, Illinois 60637
Tax ID 36-2177139
ARTICLE 5.
PATENTS: Under University policy, inventions resulting from work performed
by members of its faculty and staff are the property of the University. If
such inventions arise in the course of the work performed under this Agreement,
the University will confidentially advise the Company. The Company should
contact The Office of Technology and Intellectual Property (UChicagoTech) at 5555
South Woodlawn Avenue, Suite 300, Chicago, Illinois 60637, (773) 702-1692,
if it is interested in pursuing commercial rights to the invention.
ARTICLE 6.
CONFIDENTIALITY: The University of Chicago agrees to preserve as confidential
any and all trade secrets, privileged records and other proprietary information
belonging to the Company and disclosed to the University or its employees
during the course of the project covered by this Agreement. Excluded from
such confidential treatment shall be information which: (a) as of the date
of disclosure and/or delivery, is already known to the party receiving such
information as evidenced by prior documentation thereof; (b) is or becomes
part of the public domain, through no fault of the receiving party; (c) is
independently developed by someone not privy to the confidential information;
(d) is required for disclosure to federal or state regulatory agencies pursuant
to approval for use; or (e) is received from a third party which did not require
the recipient to hold it in confidence or limit its use and which did not
acquire it, directly or indirectly, from the other party to this Agreement
under a continuing obligation of confidentiality. The obligations of this
Article shall survive and continue for three (3) years after termination of
this Agreement.
ARTICLE 7.
PUBLICATION: The University and its employees shall have the right,
consistent with academic standards, to publish the results of research performed
under this Agreement, provided such publication does not disclose proprietary
trade secrets or confidential information of the Company. The University agrees
that, prior to submission of a manuscript describing the results for publication,
the University shall forward to the Company a copy of the manuscript to be
submitted and shall allow the Company 30 days to determine whether a patent
application or other intellectual property protection should be sought prior
to publication in order to protect the Company's proprietary interest in any
product or invention developed in connection with this project. In addition,
with reasonable justification, the University agrees to withhold such publications
an additional 60 days, if required, to obtain patent protection. At this time
the University shall be free to submit the manuscript and publish results
in any manner consistent with academic standards. The Company will have the
right to request deletion of any trade secret, proprietary, or confidential
information supplied by them to the University.
The Company will take such actions as necessary to qualify the results of the Study for publication by the University and/or Principal Investigator, including without limitation, by complying with the requirements of the International Committee of Medical Journal Editors and other applicable laws and regulations, including any applicable requirements and conditions for publication of the Food and Drug Administration pertaining to pre-initiation registration of the Study. Company shall provide proof of such registration to the University.
ARTICLE 8.
REGISTRY: The Company will take such actions as necessary to qualify the results of the Study for publication by the Institution and/or Principal Investigator, including without limitation by complying with the requirements of the International Committee of Medical Journal Editors and other applicable laws and regulations, including any applicable requirements and conditions for publication of the Food and Drug Administration pertaining to pre-initiation registration of the Study. The Company shall provide proof of such registration to the Institution.
ARTICLE 9.
ADVERTISING: The Company agrees that the name of The University of
Chicago, its trustees, officers, agents and employees will not be used for
purposes of advertising. The Company and the University will obtain written
approval from each other prior to issuing any press releases or other publicity
in connection with this Agreement.
ARTICLE 10.
USE OF EXPERIMENTAL COMPOUNDS/DRUGS: The University agrees that it
will limit its use and evaluation of experimental compounds/drugs submitted
under this Agreement to activities directly related to the Protocol named
herein, unless prior written consent has been provided by the Company.
ARTICLE 11.
HUMAN SUBJECTS: As human subjects are involved in this study, the policies
and procedures of the University's Institutional Review Board will be observed.
ARTICLE 12.
DRUGS:
a) The Company shall provide, without charge, all drugs to be studied under
this Agreement. The drug(s) shall be in appropriately marked containers.
b) The Company shall guarantee that no dosage form constituting or being part of any shipment now or hereafter made to the University in connection with the program covered by this Agreement will be adulterated or mislabeled.
ARTICLE 13.
INDEMNIFICATION: The Company undertakes to indemnify, defend and hold
harmless the Principal Investigator and the University, its trustees, officers,
agents and employees from any and all liability, loss, damage and expenses
(including attorney fees) they may suffer as the result of claims, demands,
costs or judgments which may be made or instituted against them or any of
them by reason of personal injury (including death) to any person or damage
to property arising out of or connected with the performance of the activities
to be carried out pursuant to the Protocol provided, however, that any such
liability, loss or damage resulting from (1) failure to adhere to the terms
of the Protocol or the Company's written instructions relative to the use
of the investigational drug, (2) failure to comply with any applicable FDA
or other governmental requirements or, (3) negligence or willful malfeasance
by the Principal Investigator or the University, its trustees, officers, agents
and employees is excluded from this agreement to indemnify, defend and hold
harmless.
The Principal Investigator and the University agree to notify the Company as soon as they become aware of a claim or action and to cooperate with and to authorize the Company to carry out the sole management and defense to such claim or action. The Company agrees, at its own expense, to provide attorneys to defend against any actions brought or filed against the Principal Investigator, the University, its trustees, officers, agents and employees with respect to the subject of indemnity contained herein, whether or not such claims or actions are rightfully brought or filed. The Company further agrees that if any research subject suffers adverse effects from the administration of the drug named in the study, in accordance with the Protocol, the Company will reimburse the University for all hospital and medical costs required for diagnosis and treatment.
Neither the Principal Investigator, the University, nor its trustees, officers, agents or employees shall compromise or settle any claim or action without the prior written approval of the Company.
ARTICLE 14.
CHANGES: This Agreement constitutes the entire Agreement between the
parties regarding the subject matter herein. Any modification of this Agreement
shall be made in writing and must be signed by authorized representatives
of both parties.
ARTICLE 15.
TERMINATION: Either party may terminate this Agreement upon thirty
days written notice to the other party. In the event this Agreement is terminated,
the University will be reimbursed for all non-cancelable costs incurred through
date of termination.
ARTICLE 16.
ORDER OF PRECEDENCE: In any conflict between the terms of this Agreement
and the administrative terms of the Protocol, the terms of this Agreement
shall take precedence.
| (COMPANY NAME)
By____________________________ ______________________________
______________________________
______________________________
|
THE UNIVERSITY OF CHICAGO By____________________________ _________________________ ________________________ ______________________________
|
Revised 09/06
