MTAs: An Overview MTAs: An Overview Lakita Cavin, J.D., Ph.D. Lakita Cavin, J.D., Ph.D. Staff Attorney Staff Attorney University of Tennessee University of Tennessee Research Foundation Research Foundation
Transcript
Slide 1
MTAs: An Overview Lakita Cavin, J.D., Ph.D. Staff Attorney
University of Tennessee Research Foundation
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What is an MTA? Contract Contract Any exchange of promises is a
contract Any exchange of promises is a contract License agreement
License agreement Confidentiality agreement Confidentiality
agreement Agreement on intellectual property rights Agreement on
intellectual property rights Agreement on liability Agreement on
liability Most material exchanges require MTA that must have an
institutional signature.
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Why do I need an MTA? Especially needed when proprietary
information involved Especially needed when proprietary information
involved For material coming IN, an MTA is required if the provider
requires it. For material coming IN, an MTA is required if the
provider requires it. For material going OUT, consult with the ORA
and/or UTRF For material going OUT, consult with the ORA and/or
UTRF Material is infectious or hazardous Material is infectious or
hazardous Can resolves issues: liability, academic credit, loss of
control of the material, disagreements. Can resolves issues:
liability, academic credit, loss of control of the material,
disagreements.
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What is a UBMTA Uniform Biological Materials Transfer Agreement
developed in 1995 for transfer of biological materials between
non-profit entities. Uniform Biological Materials Transfer
Agreement developed in 1995 for transfer of biological materials
between non-profit entities. Useful for simple agreements Useful
for simple agreements Between signatory institutions Between
signatory institutions Not all academic institutions are
signatories, and no industry providers are. 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 If the material is proprietary, use of the UBMTA may
not be appropriate. No IP issues Non-commercial, not-for-profit,
research purposes only Non-commercial, not-for-profit, research
purposes only In other words: No patentable invention existing or
expected In other words: No patentable invention existing or
expected
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Are MTA agreements ever enforced? In most cases, no need to
enforce. In most cases, no need to enforce. If a dispute arises,
MTA may be subject of litigation. If a dispute arises, MTA may be
subject of litigation. MTA can assist in adjudicating the dispute.
MTA can assist in adjudicating the dispute.
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Submitting an MTA: Preliminary Matters Certification form
Certification form Route Sheet Route Sheet Questionnaire (helps us
to assess project, purpose of material, and how to negotiate)
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 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) Submit to Office of Research (910 Madison Ste. 823) Biosafety
Approval (Francine Rogers) Biosafety Approval (Francine
Rogers)
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MTAs usually are related to material to be used in sponsored
research. 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. 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. Materials may be requested from multiple providers for the
same project that may be funded by multiple sources. Material may
be hazardous Material may be hazardous Why is all this
necessary?
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The Approval Process Other Institution Researcher Research
Office UTRF Third Party General Counsel Biosafety Office
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Office of Research submits to UTRF for review. Determine who
needs to be party. Determine who needs to be party. UT, Provider,
maybe UTRF. Not PI. UT, Provider, maybe UTRF. Not PI. Check to see
if provider is signatory to UBMTA. Check to see if provider is
signatory to UBMTA. Contact provider Contact provider Request
e-version Request e-version Notify that you will need to modify
Notify that you will need to modify Review/Make changes.
Review/Make changes. Submit to Office of Research for Approval
Submit to Office of Research for Approval Submit to provider for
approval(Negotiate). Submit to provider for approval(Negotiate).
May not respond right away. Have to follow up. May not respond
right away. Have to follow up. May take some time May take some
time May not ever happen. May not ever happen. If Provider
approves, notify Office of Research that other party agrees to
changes. If Provider approves, notify Office of Research that other
party agrees to changes. Submit for signatures. Submit for
signatures. Foreign MTAs have to be approved by General Counsel
(Knoxville) Foreign MTAs have to be approved by General Counsel
(Knoxville) Send signed copies to Provider. Send signed copies to
Provider. Why does the process take so long?
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Important Factors NIH Guidelines/Funding Agreements NIH
Guidelines/Funding Agreements Journal Requirements Journal
Requirements UT policy and state law UT policy and state law
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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.Promote utilization, commercialization and public
availability of inventions. NIH Guidelines for Sharing Biomedical
Research Resources
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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) 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) Each
author should have participated sufficiently in the work to take
responsibility for appropriate portions of the content. (JAMA) Each
author should have participated sufficiently in the work to take
responsibility for appropriate portions of the content. (JAMA)
Journal Requirement
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Problem provisions Problem provisions Definition of Material
Definition of Material modifications modifications derivatives
derivatives Limit to original materials, progeny, unmodified
derivatives Limit to original materials, progeny, unmodified
derivatives If modifications and derivatives included, Provider
would own results and prevent PI from using own results If
modifications and derivatives included, Provider would own results
and prevent PI from using own results Intellectual Property
Intellectual Property Ownership, control, and management Ownership,
control, and management Can conflict with funding agreements and
prevent future use and licensing of technology Can conflict with
funding agreements and prevent future use and licensing of
technology Publication Restrictions (manuscript, abstract,
presentation) Publication Restrictions (manuscript, abstract,
presentation) Provider requests review to determine if patentable
inventions (Can cause publication delays ) Provider requests review
to determine if patentable inventions (Can cause publication delays
) Provider requests written consent to publish Provider requests
written consent to publish Provider requests coauthorship Provider
requests coauthorship Violates academic freedom, conflict with
funding agreement and journal requirements Violates academic
freedom, conflict with funding agreement and journal requirements
Conflicts with existing agreements. Conflicts with existing
agreements. 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. 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 Permission from 3rd
party Notify provider of 3rd party mta Notify provider of 3rd party
mta Could present IP problems Could present IP problems
Inventorship determined later Inventorship determined later
Potential Issues
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Biggest Issues Biggest Issues / Indemnification/Liability
(financial responsibility) Prohibited TCA 9-8-301 et seq.) 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 Choice of law (governing law), jurisdiction.
Choice of law (governing law), jurisdiction. Request to remain
silent on law. Request to remain silent on law. Illegal aliens
Illegal aliens Prohibits entering into contract for goods or
services with any person who knowingly uses services of illegal
immigrants Prohibits entering into contract for goods or services
with any person who knowingly uses services of illegal
immigrants
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Post-Approval Signed copies sent to Provider Signed copies sent
to Provider Provider sends material, hopefully. Provider sends
material, hopefully. Follow-up if necessary. Follow-up if
necessary.
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Additional Notes MTA required when materials come in or go
out.MTA required when materials come in or go out. You should NOT
be signing MTA as a party. Remember Try to make sure you can obtain
material before submitting grant.
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How long will this take? Less time than it took in the past.
Less time than it took in the past. I am the central contact point
for negotiations between UT and the other party. I am the central
contact point for negotiations between UT and the other party.
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Improvements Faster process Faster process More communication
More communication Provide information on the approval process
Provide information on the approval process Provide information on
status of pending MTA Provide information on status of pending MTA
Listen to your concerns Listen to your concerns
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Resources on MTAs AUTM Educational Series: Material Transfer
Agreements AUTM Educational Series: Material Transfer Agreements
Berkeley Quick Guide to MTAs: Berkeley Quick Guide to MTAs:
www.spo.berkeley.edu/guide/mtaquick.h tml
www.spo.berkeley.edu/guide/mtaquick.h tml COGR booklet: COGR
booklet: www.cogr.edu.docs/MaterialsTransfer.p df
www.cogr.edu.docs/MaterialsTransfer.p df FDA chart:
www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm FDA chart:
www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm
www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm
www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm UT contract
terms : http://www.utmem.edu/research/cli
nical_study/contract_term.pdf UT contract terms :
http://www.utmem.edu/research/cli
nical_study/contract_term.pdf
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Resources (contd) Journal of the American Medical Association
(JAMA) Manuscript Criteria and Information:
http://jama.ama-assn.org/ifora_current.dtl Journal of the American
Medical Association (JAMA) Manuscript Criteria and Information:
http://jama.ama-assn.org/ifora_current.dtl
http://jama.ama-assn.org/ifora_current.dtl NIH Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: 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
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 Proceedings of the National
Academy of Sciences Information for Authors:
http://www.pnas.org/misc/iforc.shtml
http://www.pnas.org/misc/iforc.shtml
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Contact Info Lakita Cavin, J.D., Ph.D.(UTRF, Memphis) Lakita
Cavin, J.D., Ph.D.(UTRF, Memphis) 920 Madison Ave., Ste. 515 920
Madison Ave., Ste. 515 (901) 448-7825 (901) 448-7825
[email protected] Van Irion, J.D. (UTRF, Knoxville) Van Irion, J.D.
(UTRF, Knoxville) 1534 White Ave., Ste. 403 1534 White Ave., Ste.
403 (865) 974-9559 [email protected] Deborah L. Smith, Ed.D.(ORA)
Deborah L. Smith, Ed.D.(ORA) 910 Madison Ave., Ste. 823 910 Madison
Ave., Ste. 823 (901) 448-4823 (901) 448-4823 [email protected]
Francine Rogers(Biosafety) Francine Rogers(Biosafety) 910 Madison
Ave., Ste. 650 910 Madison Ave., Ste. 650 (901) 448-3537 (901)
448-3537 [email protected][email protected]@utmem.edu