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UNIVERSITY POLICY

I.        PURPOSE

To set UMDNJ policy for the transfer and receipt of chemical compounds, medical devices, diagnostic kits, blood samples, other body fluids, samples of tissue, organs, plasmids, other vectors, DNA or RNA samples, viruses, bacteria, hybridomas or any other materials obtained from patients or isolated or created while using University facilities and/or funds.

II.       ACCOUNTABILITY

Under the direction of the President, the Vice President for Legal Management shall ensure compliance with this policy.  The Director of Patents and Licensing shall implement this policy.

III.     APPLICABILITY

A.      All University personnel, including every person holding any form of teaching or research appointment, fellows and non-academic staff holding appointments at or employed by the University.

B.      All students enrolled at the University.

IV.     DEFINITIONS

A.      Developer - Any individual named in section III above who isolates, purifies, develops, synthesizes or makes any material or device which is of technical, commercial, or educational value to an outside researcher, institution or company.

B.      Recipient - Any individual named in section III above who receives a biological material which is of technical, commercial or educational value to an outside researcher, institution or company.

V.      REFERENCES

A.      Patents                                                                00-01-90-45:00

B.      Legal Commitment Authority                                00-01-90-05:00

VI.     POLICY

A.      The University of Medicine and Dentistry of New Jersey is committed to fostering research related to the advancement of scientific knowledge and to the publication and the use of the results of such research.  While such research performed with the facilities and/or funds of the University by faculty, staff and students is not intended to be a profit making endeavor, the University recognizes that some research may lead to the isolation or production of materials which may be of scientific or commercial value to other institutions or companies.  The transfer of such materials should be carried out only through the University's Office of Patents and Licensing under the terms of a written agreement for one or more of the following reasons:

1.        to ensure that the materials will only be used in compliance with all Federal or State rules governing the use of such materials;

2.        to shield the University, its faculty members and other employees from liability if the materials are used in an inappropriate, unintended, illegal or dangerous fashion;

3.        to confirm that, in the case of any materials obtained from patients, a suitable consent form has been executed and that the University has rights to the material;

4.        to comply with the requirements of Federal, State or private research grants, awards and contracts for research;

5.        to make sure that potential intellectual property rights are not jeopardized;

6.        to ensure that the University obtains an appropriate return on its investment in the staff and facilities of the University.

B.      Receipt of Materials

The University of Medicine and Dentistry of New Jersey is committed to fostering research related to the advancement of scientific knowledge and to the publication and the use of the results of such research.  The University also recognizes that research requires collaboration with outside parties that may have an interest in materials being received by the University.  Therefore, the receipt of such materials should be carried out only through the University's Office of Patents and Licensing under the terms of a written agreement for one or more of the following reasons:

1.        to shield the University, its faculty members and other employees from liability if the materials are used in an inappropriate, unintended, illegal or dangerous fashion;

2.        to comply with the requirements of Federal, State or private research grants, awards and contracts for research;

3.        to make sure that potential intellectual property rights are not jeopardized;

C.      Ownership of Materials

All materials developed with University support or using University facilities shall belong to the University.

D.      Administration of Contracts for the Transfer or Receipt of Materials

The Office of Patents and Licensing in the Office of Legal Management shall be responsible for providing information and assistance on contracts for the transfer and receipt of materials after consultation with the developer(s) of the material(s).

E.      Disclosure Responsibilities of the Developer(s) of Material(s)

1.        Every developer of a material, who has received a request for its transfer to an outside person or entity should, promptly contact the Director of Patents and Licensing who will advise the developer as to the procedure to be followed.  The Director of Patents and Licensing will, within a reasonable period of time, provide a suitable agreement for the transfer without payment of the material.  All agreements for the transfer of materials belonging to the University shall be signed on behalf of the University by the President or by another officer with the authority to commit the University under the University policy, Legal Commitment Authority, 00-01-90-05:00.

2.        When any question exists as to whether a material is covered by this policy, the material must be disclosed through the usual disclosure mechanism described above, with a request for a determination as to whether the material is covered.  In cases where a developer seeks to establish that a material is not covered by this policy, the burden of proof shall be with the developer.

F.      Distribution of Income from Sales of Materials and Devices shall be governed by the Policy, Patents, 00-01-90-45:00.

By Direction of the President:

__________________________________
Vice President for Legal Management

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