The University of Wisconsin School of Medicine and Public Health, along with many other institutions and companies, uses material transfer agreements (MTAs) to govern the transfer of research materials. Use of material transfer agreements has risen dramatically in the past few years, primarily associated with the transfer of unique biological materials.
Likely reasons for this increase are the rise of the biotechnology industry, which generates many unique biological materials of interest to academics, which companies are not eager to provide without significant controls, and the increasing activity of universities in patenting and licensing, and their consequent interest in protecting their rights in materials transferred out of their institutions.
Material Transfer Agreements for Incoming Materials
Material Transfer Agreements signed by an authorized university representative are required to be in place before any research material can be received by a University of Wisconsin-Madison investigator. Investigators may not sign and return MTAs to providers.
Material transfer agreements from academic and government laboratories
National Institutes of Health (NIH)-funded research comes with the obligation to share unique resources (biological materials) generated. NIH has recommended that such materials be transferred using one of two standard contracts, the Universal Biological MTA (UBMTA) or the Simple Letter Agreement for the Transfer of Materials.
When a provider uses either of these two agreements, the transfer of materials can occur quickly. Unfortunately, many institutions have developed their own variants, and every variation results in the need for review to insure consistency with university policy.
Industry material transfer agreements
It is important to recognize that companies are under no obligation to provide proprietary materials, which they have developed as a result of their own efforts and investment, to academic researchers, other than the obligation that all scientists, industrial as well as academic, assume to share materials with colleagues, under reasonable terms, when they publish.
Absent this, companies may attach any stipulation they wish to sharing their materials, and at times these stipulations, expressed as contract terms, are inconsistent with academic policies and values. If non-negotiable, the terms may prevent the material from being obtained. Nonetheless, the OIP makes every effort in these situations to find common ground with company providers and put agreements into place.
These MTAs may take weeks or months to negotiate and involve the investment of thousands of dollars of administrative effort. Before pursuing the negotiation of these material transfer agreements, the Office of Industry Engagement needs to obtain an understanding of the way the material may be used, and the options the investigator has to make or buy the material, or to modify an experiment to avoid using the material. In these cases, OIE may send a supplemental form to the principal investigator to gather this information.
It is important to recognize that materials obtained from industry under material transfer agreements are not free. In addition to the costs incurred by the university in administrative effort to negotiate MTAs and the time lost while negotiations are in progress, the rights companies expect to obtain to discoveries made using the material may be worth hundreds of thousands of dollars.
Therefore, investigators should consider alternatives to obtaining materials under an MTA if it has problematic terms and conditions. In general, if the material can be obtained commercially for less than $5000, it will be difficult to justify an intensive effort to establish an MTA.
Material Transfer Agreements for Outgoing Materials
University of Wisconsin-Madison policy does not require that material transfer agreements be in place before materials are shipped from the university, unless they are human tissues or specimens resulting from research that has been conducted under an Institutional Review Board (IRB)-approved protocol. In that case, IRB approval must be in place.
For all situations, however, the University of Wisconsin School of Medicine and Public Health requires that MTAs be used for transfers to industry, and strongly recommends that MTAs be used for other cases as well. The use of an outgoing material transfer agreement provides an opportunity to consider issues such as control over further distribution of your material by the recipient, and whether a company should license your material rather than receive it at no cost. MTAs for transfer to academic labs can be easily handled by using the Simple Letter Agreement or UBMTA.
Frequent transfers
Several outside organizations have been established as repositories for investigators’ materials. They will accept deposits and manage the transfer to other investigators. This option should be considered when an investigator has a material that is frequently requested.
- AddGene: a nonprofit repository for plasmids
- American Type Culture Collection (ATCC): a nonprofit repository for cell lines and other materials
- Mutant Mouse Regional Resource Center (MMRRC): a nonprofit repository for genetically engineered mouse lines
- Jackson Laboratory: a nonprofit repository for genetically engineered mouse lines
Procedures for Establishing Material Transfer Agreements
Material Transfer Agreements for Incoming Materials
1. Identify the material transfer agreement to be used.
The proposed agreement is obtained by the investigator. Typically, the provider of the material will propose the agreement to be used. However, if the provider is an investigator at an academic institution, the UW-Madison investigator should propose that the UBMTA (if the recipient institution is listed as a signatory to the UBMTA) or Simple Letter Agreement be used.
Use of either of these agreements, exactly as written, is the key to rapid transfer of materials from other universities, because they have been prereviewed by UW and all terms are consistent with university policy. All other agreements with other universities and all agreements with companies require review and, in most cases, negotiation.
2. Prepare the WISPER record
The principal investigator and/or staff, with the help of departmental administration as needed, completes the WISPER record. Questions regarding this procedure should initially be directed to departmental administrators, who have been trained to enter agreements into WISPER. Note especially the following items in WISPER that need to be completed for material transfer agreements:
- The account number for the project that will provide the funds for the experiments to be done with the material should be listed in the Official Title field under the General tab. This account should be currently active, and the principal investigator requesting the material should be the principal investigator on the account.
- If use of the material requires biohazard approval or involves human subjects, list the protocol numbers covering the project account number that was cited as the funding source. If its use involves vertebrate animals, please upload the approval letter received from Research Animal Resources Center (RARC) to the WISPER record. The approvals should cite the project account numbers. If these are pending, note this. While we can continue to process the agreement, the material cannot be used until the approvals are in place.
- If the MTA is to be sent by overnight delivery, scan and upload the shipping label. There is no need to send an envelope through the system.
- Under the Comments tab, provide the name, e-mail address and/or phone number for the person at the providing institution/company to whom questions about the contract language should be addressed. Also, any background information on the history of the request, such as e-mails, may be inserted and can be useful for negotiations.
- Under Submission Instructions, please provide the full name and address to which the signed MTA should be sent.
- If the UBMTA or Simple Letter are not used, and the provider is another academic institution, ask the provider for the material transfer agreement as a Microsoft Word document, and upload this document to the WISPER record. If the provider declines to provide a Word document, please note this in the Comments section.
3. Prepare the material transfer agreement for submission
- The material transfer agreement should be read by the principal investigator, and any concerns noted in the Comments section of the WISPER record.
- All blanks in the MTA should be filled in before routing the record to the dean’s office, except a space left for insertion of the date of execution, typically in the first paragraph, and the spaces for institutional signature and identification of the institutional signatory.
- The material transfer agreement should list, as the recipient, the “Board of Regents of the University of Wisconsin System on behalf of the University of Wisconsin-Madison,” and if a business address is required, normally in the opening paragraph, it should be “21 N. Park St., Suite 6401, Madison, Wisconsin 53715.” Do not list the name and address of the principal investigator, department, or University of Wisconsin School of Medicine and Public Health as the recipient party. The address to which the material is to be sent typically appears elsewhere in the agreement.
- If the material transfer agreement requires that the principal investigator be named, the person should be a faculty member with a tenure-track, CHS or Clinical appointment, or a UW-Madison investigator with permanent or temporary principal investigator status. Do not list graduate students, post-docs, etc. Note that this is an especially common problem for material transfer agreements from Addgene, and if an individual without principal investigator status is named in the agreement, the agreement will be returned for revision.
- The principal investigator should only sign the MTA if there is a blank labeled specifically as a principal investigator signature line. The principal investigator should not sign in a space intended for the institutional signature.
- If a principal investigator’s signature is required, upload to the WISPER record a PDF of the signed material transfer agreement. If the MTA is not the UBMTA or Simple letter and is from another university or a company, also upload a Microsoft Word version, if available. Either a Word version or a PDF are satisfactory for a UBMTA, Simple Letter or an MTA from a federal agency or nonprofit biobank such as Addgene or Jackson Laboratory.
4. Send PI signature request for the WISPER record and chair approval for sign-off
Then route to SMPH for dean’s office review.
5. Route paper copies
If a principal investigator’s signature on the material transfer agreement is required, send two paper copies of the MTA, each with an original signature, to Andy Chen at the Office of Industry Engagement.
6. Material transfer agreement processing by the Office of Industry Engagement and the Office of Industrial Partnerships
The Office of Industry Engagement will review the WISPER record for completeness, and route the record back to the listed departmental contact if all the required information is not filled in, or if additions or corrections are needed. Note that this adds effort and delays the process, so it is important for the WISPER record to be complete upon initial routing.
- Once the WISPER record is complete, OIE will review the MTA itself. If it is a standard document such as the UBMTA, Simple Letter, or some forms used by certain federal agencies and nonprofit biobanks, it can be sent by OIE to OIP for signature without further action by OIE. If not, the Office of Industrial Partnerships will review the material transfer agreement for consistency with university policy and negotiate changes with the provider where needed.
- Once the language in the MTA conforms to university policy, the principal investigator and departmental contact will be notified.
- The OIP will perform a final review of all documents and sections of WISPER. OIP will then send the agreement to the sponsor based upon the original submission method listed. After receiving a fully executed agreement from the sponsor, OIP will upload a scanned version to WISPER, and change the record status to 6-Completed. The PI, department contact, and OIE will receive a WISPER notification of this status change. The principal investigator can now obtain the requested materials or begin the research project.
Material Transfer Agreements for Outgoing Materials
1. Identify the material transfer agreement to be used
If the recipient is an academic institution, the UBMTA Implementing Letter (if the recipient institution is listed as a signatory to the UBMTA) or Simple Letter Agreement should be used. The UW investigator should confirm with the recipient scientist that one of these MTAs is acceptable. If the recipient scientist wishes to use a different MTA, or the material is being sent to a company, please contact Andy Chen at the Office of Industry Engagement for guidance.
2. Prepare the WISPER Record
The principal investigator and/or staff, with the help of departmental administration as needed, completes the WISPER record. Questions regarding this procedure should initially be directed to departmental administrators, who have been trained to enter agreements into WISPER. Outgoing MTAs do not need regulatory approval information completed or funding sources listed.
The following items in WISPER need to be completed:
- If the MTA is to be sent by overnight delivery, please scan and upload the shipping label. There is no need to send an envelope through the system.
- Under Submission Instructions, please provide the full name and address to which the signed MTA should be sent.
3. Prepare the material transfer agreement for submission
- All blanks in the material transfer agreement should be filled in before routing the record to the dean’s office, except a space left for insertion of the date of execution, typically in the first paragraph, and the spaces for recipient’s signature and date, and the provider’s institutional signature and date, if any.
- The MTA should list, as the provider organization, the University of Wisconsin-Madison, 21 N. Park St., Suite 6401, Madison, Wisconsin 53715. Do not list the name and address of the principal investigator, department, or UW School of Medicine and Public Health as the provider organization.
- The provider scientist listed on the MTA must be a faculty member with a tenure-track, CHS or Clinical appointment, or a UW-Madison investigator with permanent principal investigator status. Do not list graduate students, post-docs, etc.
- The principal investigator should sign the material transfer agreement as the provider scientist. The principal investigator should not sign in a space intended for the institutional signature.
- If a principal investigator signature is required, upload to the WISPER record a PDF of the signed material transfer agreement. If the MTA is not the UBMTA or Simple letter and is from another university or a company, also upload a Microsoft Word version, if available. Either a Word or PDF version are satisfactory for a UBMTA or Simple Letter.
4. Obtain PI signature and chair approval
Then route to Andy Chen for dean’s office review.
5. Route paper copies
If a PI signature on the MTA is required, send two paper copies of the MTA, each with an original signature, to Andy Chen at OIE.
6. Material transfer agreement processing by the Office of Industry Engagement and the Office of Industrial Partnerships
- The Office of Industry Engagement will review the WISPER record for completeness, and route the record back to the listed departmental contact if all the required information is not filled in, or if additions or corrections are needed. Note that this adds effort and delays the process, so it is important for the WISPER record to be complete upon initial routing.
- Once the WISPER record is complete, OIE will review the MTA itself. If it is a standard document such as the UBMTA or Simple Letter, it can be sent by OIE to OIP for signature without further action by OIE. If not, OIP will review the MTA for consistency with University policy, and negotiate changes with the recipient where needed.
- Once the language in the material transfer agreement conforms to UW-Madison policy, the principal investigator and departmental contact will be notified.
- OIP performs a final review, signs the agreement and sends to the recipient. Once the agreement is signed by all parties, the principal investigator is notified by OIP that the material can be sent.