MTAs: An Overview
Lakita Cavin, J.D., Ph.D.
Staff Attorney
University of Tennessee Research Foundation
What is an MTA?
Most material exchanges require MTA that
must have an institutional signature.
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Contract
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Any exchange of promises is a contract
License agreement
Confidentiality agreement
Agreement on intellectual property rights
Agreement on liability
Why do I need an MTA?
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Especially needed when proprietary
information involved
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For material coming IN, an MTA is required if the
provider requires it.
For material going OUT, consult with the ORA
and/or UTRF
Material is infectious or hazardous
Can resolves issues: liability, academic credit,
loss of control of the material, disagreements.
What is a UBMTA
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Uniform Biological Materials Transfer Agreement
developed in 1995 for transfer of biological materials
between non-profit entities.
Useful for simple agreements
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Between signatory institutions
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Not all academic institutions are signatories, and no industry
providers are.
If the material is proprietary, use of the UBMTA may not
be appropriate. No IP issues
“Non-commercial”, “not-for-profit”, “research purposes
only”
In other words: No patentable invention existing or
expected
Are MTA agreements ever enforced?
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In most cases, no need to enforce.
If a dispute arises, MTA may be subject of
litigation.
MTA can assist in adjudicating the dispute.
Submitting an MTA: Preliminary
Matters
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Certification form
Route Sheet
Questionnaire (helps us to assess project, purpose of
material, and how to negotiate)
Forms available at
http://www.utmem.edu/research/research_admin/inde
x.php?doc=forms.htm
Submit to Office of Research (910 Madison Ste. 823)
Biosafety Approval (Francine Rogers)
Why is all this necessary?
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MTAs usually are related to material to be used in
sponsored research.
Terms of the MTA may conflict with terms of the
grant or contract under which the research is funded.
Materials may be requested from multiple providers
for the same project that may be funded by multiple
sources.
Material may be hazardous
The Approval Process
Biosafety Office
General
Counsel
Research
Office
UTRF
Other
Institution
Researcher
Third Party
Why does the process take so long?
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Office of Research submits to UTRF for review.
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Determine who needs to be party.
 UT, Provider, maybe UTRF. Not PI.
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Check to see if provider is signatory to UBMTA.
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Contact provider
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Request e-version
Notify that you will need to modify
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Review/Make changes.
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Submit to Office of Research for Approval
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Submit to provider for approval(Negotiate).
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May not respond right away. Have to follow up.
May take some time
May not ever happen.
If Provider approves, notify Office of Research that other party agrees to
changes.
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Submit for signatures.
Foreign MTAs have to be approved by General Counsel (Knoxville)
Send signed copies to Provider.
Important Factors
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NIH Guidelines/Funding Agreements
Journal Requirements
UT policy and state law
NIH Guidelines for Sharing
Biomedical Research Resources
Bayh-Dole
In 1980, the Bayh-Dole Act (PL 96-517, Patent and Trademark Act Amendments of
1980) created a uniform patent policy among the many federal agencies funding
research. As a result of this law, universities retain ownership to inventions
made under federally funded research.
•Under the Bayh-Dole Act and its implementing regulations, agreements to
acquire materials for use in NIH-funded projects cannot require that title to
resulting inventions be assigned to the provider.
•For this reason, definitions of “material” that include all derivatives or
modifications are unacceptable. Other unacceptable variations include
improvements, or any other materials that could have not been made without
the provided material.
unacceptable.
•Promote utilization, commercialization and public availability of inventions.
Journal Requirement
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Authors must make
UNIQUE MATERIALS
(e.g., cloned DNAs;
antibodies; bacterial,
animal, or plant cells;
viruses; and computer
programs) promptly
available on request by
qualified researchers for
their own use. (PNAS)
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Each author should have
participated sufficiently
in the work to take
responsibility for
appropriate portions of
the content. (JAMA)
Potential Issues
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Problem provisions
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Definition of Material
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Intellectual Property
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Ownership, control, and management
Can conflict with funding agreements and prevent future use and licensing of technology
Publication Restrictions (manuscript, abstract, presentation)
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modifications
derivatives
Limit to original materials, progeny, unmodified derivatives
If modifications and derivatives included, Provider would own results and prevent PI from using
own results
Provider requests review to determine if patentable inventions (Can cause publication delays )
Provider requests written consent to publish
Provider requests coauthorship
Violates academic freedom, conflict with funding agreement and journal requirements
Conflicts with existing agreements.
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Use with other compounds under another MTA. Could result in granting both parties conflicting
rights to invention. We have to know if material will be used with other compounds and review
that MTA.
Permission from 3rd party
Notify provider of 3rd party mta
Could present IP problems
Inventorship determined later
Potential Issues
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Biggest Issues
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Indemnification/Liability (financial responsibility)
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Choice of law (governing law), jurisdiction.
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Prohibited
UT is an agency of the State of Tennessee and cannot indemnify or
hold harmless. (TCA 9-8-301 et seq.) (violate the Constitution of the
State of Tennessee)
UT can agree to be responsible for its actions and those of its
employees to the extent allowed by law.
Frivolous lawsuits can happen
Request to remain silent on law.
Illegal aliens
 Prohibits entering into contract for goods or services with any
person who knowingly uses services of illegal immigrants
Post-Approval
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Signed copies sent to Provider
Provider sends material, hopefully.
Follow-up if necessary.
Additional Notes
Remember
•MTA required when materials come in or go out.
•You should NOT be signing MTA as a party.
•Try to make sure you can obtain material before
submitting grant.
How long will this take?
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Less time than it took in the past.
I am the central contact point for negotiations
between UT and the other party.
Improvements
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Faster process
More communication
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Provide information on the approval process
Provide information on status of pending MTA
Listen to your concerns
Resources on MTAs
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AUTM Educational Series: Material
Transfer Agreements
Berkeley Quick Guide to MTAs:
www.spo.berkeley.edu/guide/mtaquick.h
tml
COGR booklet:
www.cogr.edu.docs/MaterialsTransfer.p
df
FDA chart:
www.fda.gov/oc/ofacs/partnership/techt
ran/criteria.htm
UT contract terms:
http://www.utmem.edu/research/cli
nical_study/contract_term.pdf
Resources (cont’d)
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Journal of the American Medical Association
(JAMA) Manuscript Criteria and Information:
http://jama.ama-assn.org/ifora_current.dtl
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NIH Principles and Guidelines for Recipients of
NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical
Research Resources:
http://ott.od.nih.gov/NewPages/RTguide_final.h
tml
Proceedings of the National Academy of
Sciences – Information for Authors:
http://www.pnas.org/misc/iforc.shtml
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Contact Info
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Lakita Cavin, J.D., Ph.D.(UTRF, Memphis)
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Van Irion, J.D. (UTRF, Knoxville)
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1534 White Ave., Ste. 403
(865) 974-9559
virion@utk.edu
Deborah L. Smith, Ed.D.(ORA)
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920 Madison Ave., Ste. 515
(901) 448-7825
lcavin@utmem.edu
910 Madison Ave., Ste. 823
(901) 448-4823
dsmith@utmem.edu
Francine Rogers(Biosafety)
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910 Madison Ave., Ste. 650
(901) 448-3537
frogers1@utmem.edu