Why sign an MTA?
Who signs MTAs?
For-Profit vs Nonprofit MTAs - How are they different?
Do we still need a Cre-Lox license?
What are the common issues that cause delays?
What about compliances?
Why sign an MTA?
Prior to the transfer of material, MTAs address the
issues of liability, publication, and intellectual property rights that
may result from the research. In addition, concerns such as limits on
the use of the materials are frequently included in MTAs. The understanding
established by the MTA can help avoid later issues and ensure the collaborative
nature of the research.
Who signs MTAs?
The University of Pittsburgh's Office of Research is
designated as the office to enter into research contracts on behalf of
the University and this includes MTAs. When a researcher signs such an
agreement on behalf of the University of Pittsburgh, the researcher could
be subjected to legal and financial risks. MTAs, while usually not conveying
funding, are still binding documents with possible legal penalties for
violations of the terms. It is important for the researcher to read the
terms of an MTA before transmitting it for University signature. The Office
of Research assumes that a researcher who transmits an MTA has read and
agrees to conform to those terms (http://www.pitt.edu/HOME/PP/policies/11/11-01-02.html).
The Office of Research will confer with General Counsel and the Office
of Technology Management (http://tech-link.tt.pitt.edu/)
For-Profit vs Nonprofit MTAs-
How are they different?
The transfer of materials to or from from a nonprofit
institution should be as unencumbered as possible. Typically, most universities
and nonprofit entities use a simple agreement with few restrictions and
agreement is reached expeditiously.
The transfer of materials to or from the for-profit
sector is usually more complex, as the corporate entity has an often aggressive
interest in protecting its proprietary rights, a stance that can lead
to restrictive language in the agreement that the University of Pittsburgh
cannot accept. There are also a number of differing contractual formats
for transfer of materials from industry, and MTAs can even be called by
different names. Therefore, for incoming materials, we must evaluate each
case individually and this takes time. For outgoing materials all recipients
must use our template.
Do we still need a Cre-Lox
The University of Pittsburgh had a Cre-Lox license
originally signed in 1997 and updated in 2007. Cre-Lox was a tool developed
by DuPont for site-specific recombination of DNA in eukaryotic cells. It
regulates the expression of engineered genes at Lox sites through activation
of a regulatory sequence that controls the expression of the recombinase
Cre gene. Cells can be grown, then turned on, to make the transcript of
choice. We have been advised that the US patents for this technology have
expired, and use no longer requires a license. Thus the license agreement
are the common issues that cause delays?
- Submission of incomplete agreements and forms
to the University of Pittsburgh's Office of Research:
- If an MTA is to be submitted in duplicate, we will need two signed
original copies. Researchers must sign prior to the Office of Research
- If the MTA requires a research scope to be attached, please attach
it for submission.
- If the MTA requires materials to be filled in, please do so.
The Office of Research cannot sign incomplete agreements.
- No contacts provided for negotiation
If you have the name and e-mail address of a contact person for the
other party, please provide this information on the submission form
to expedite the process of negotiation.
- Intellectual property or publication restrictions
The University will not sign any agreement with “reach through”
intellectual property rights or publication restrictions. "Reach
through" rights are when a Provider obtains rights to improvements,
modifications or inventions made by the researcher in the course of
the research, and this can even include royalty or fees paid to the
provider. Generally, the NIH requires recipients of federal funds to
make research resources available without "reach through"
- Conflicting contractual obligations
MTAs that relate to other sponsored agreements or MTAs must be carefully
evaluated to ensure that we do not have terms between the multiple documents
that conflict with one another. When the terms of an MTA conflict with
another agreement, changes will have to be negotiated, and this may
- Governing law outside of Pennsylvania
The University is a state-related educational institution and cannot
sign agreements that are governed outside of Pennsylvania, or out of
the US. This also means that most arbitration language cannot be accepted.
- Warranty or indemnification
The University is a nonprofit entity and cannot provide warranties for
research, results, or materials. We cannot agree to indemnify a sponsor
against harm or damages from use of results or materials. The University
of Pittsburgh's indemnity is limited to responsibility for our own negligent
MTAs undergo compliance review before signing. If you submit an MTA
for animals, and you do not include the IACUC approval letter, this
will result in a delay in processing as we attempt to obtain that document.
The same is true of human subject protocols, hazardous materials, radioactive
items and any materials that require approval. Submission of the approval
letter with the MTA saves you time.
- Foreign party involvement, or the transfer
of controlled information or technology
The involvement of these items in an MTA may mean that the document
must be reviewed for compliance with US Federal Export Control regulations
This is a necessary process to ensure that the University of Pittsburgh
remains safely within the fundamental research exemption.
- Other party unwillingness to negotiate
Some MTAs are presented as containing non-negotiable language. While
the Office of Research is frequently successful in negotiating appropriate
language, we cannot negotiate with a party who is unwilling to do so.
the Office of Research will make more than one attempt to enter into
a dialog, but if the other party is unwilling, our options are quite
What about compliance?
MTAs are contractual documents that are held to
the same levels of compliance review (http://www.rcco.pitt.edu/)
as a proposal for funding or a grant.
Submission of these approval letters with your
MTA will expedite the review process.