• Whether the materials will be used on a project that has funding terms and conditions.
  • Many MTAs restrict use of the materials to internal research or non-commercial purposes. Please consider the terms and conditions of any existing projects you have that will coincide with your use of the material(s) since the agreements for these projects may provide deliverables or grant access to resulting intellectual property to the project sponsor. The provision of the deliverables or intellectual property may conflict with the terms of the MTA.
• Whether the materials will be used with other materials subject to restrictions or legal obligations to the third-party provider (e.g. other materials purchased subject to terms and conditions or obtained under a license or another MTA).
  • This relates to the internal research/non-commercial use limitation. If we intend to use the requested materials in conjunction with third-party materials, those third-party materials may have been obtained subject to an MTA (or other terms and conditions) that requires us to provide deliverables or access to resulting intellectual property to that third party. These provisions would then conflict with the terms of the material being requested.
• Whether you expect to share the materials with collaborators (internal or external to UW) or otherwise further distributed.
  • MTAs often include restrictions on how and to whom materials (and often modifications) can be shared. For example, some state that the materials may not be shared outside of the recipient scientist’s lab and prohibit any further distribution of the original material, and some state that we can only further distribute modifications under terms substantially the same as the terms under which we obtained the materials. If there’s a plan to share now or in the future, we should address that need upfront to speed up the process later.

Please keep these consideration in mind as you are pursuing the receipt of materials. If these considerations for incoming materials raise concerns for you, please discuss with RSP prior to signature of the agreement. RSP can negotiate incoming material transfer agreements based on discussions with you. After an In-MTA has been executed, it is the responsibility of the PI to abide by the terms and conditions of the agreement.

• Whether the materials were assigned to WARF.
  • If materials have been assigned to WARF, UW does not have the legal right to distribute them without WARF’s consent, and often WARF will need to negotiate a license with the requestor first. Please contact your WARF Licensing Manager to discuss the sharing of these materials.
• Whether the materials were obtained from a third party, or contain or incorporate materials obtained from a third party.
  • The agreement under which we obtained the materials my prevent us from further distributing them, or may impose specific terms on how and to whom we may further distribute the materials or modifications of the materials. If this is the case, we need to see if there’s any ability for us to share the materials.
• Whether the materials were created subject to a fee for service or research agreement.
  • If the materials are considered deliverables under a service agreement or results under a research agreement, we likely have already granted rights to such materials to the sponsor of that original project and may not have the legal right to further distribute the materials to third parties. If this is the case, we need to see if there’s any ability for us to share the materials.
• If applicable, whether we received verification from IRB that sharing of the materials is allowed under the applicable protocol/consent forms.
  • This only pertains to materials that were derived from human subjects by UW. Prior to distribution of materials, subjects must have been informed of the intent to share their materials and must have given their consent to such sharing.

For WiCell deposits, a specific process has been worked out between UW-Madison and WiCell. This process, outlined below, can be saved or printed here.

• PI contacts WiCell (Dr. Tenneille Ludwig) to initiate the process of depositing materials.
• WiCell provides PI WiCell-UW Deposit Worksheet, and instructions to complete an Invention Disclosure Form with WARF. Requested information across forms is similar and need only be entered on the WiCell Deposit Form, and investigators should reference the WiCell Deposit Worksheet on the Invention Disclosure Form instead of duplicating the information.
• PI sends completed WiCell-UW Deposit Worksheet back to WiCell (Dr. Tenneille Ludwig).
• Dr. Ludwig forwards WiCell Deposit sheet to WARF for review along with the PI completed Invention Disclosure Form.
• WARF reviews Invention Disclosure Form and sends to UW Equity Review Office.
• UW Equity Review Office sends results of equity review to PI via Equity Review Letter.
• PI/Department downloads and completes the Biomaterial Addendum.
• PI and Department initiate RAMP Agreement record for deposit. RAMP Agreement record should include the Biomaterial Addendum (signed by PI) and the Equity Review finding letter as an Other supporting document.
• PI and Department route the RAMP Agreement record to the appropriate Dean's Office.
• Dean's Office reviews and, if complete, approves the RAMP Agreement record and routes to RSP.
• RSP reviews record and determines if there are any other terms required for the MTA that WiCell will use for third parties. The MTA template is the AUTM template. Other terms may come from existing contractual arrangements that govern the material (sponsored agreements, other MTAs, etc.).
• RSP signs the Biomaterial Addendum, attaches the MTA to the addendum, and sends to WiCell.
• WiCell contacts PI to inform that all documentation has been completed.
• WiCell makes materials available through the following process:
• Contact investigator to obtain any additional information needed for receipt, culture, or web listing (any recent publications, etc.)
• Once complete, receive materials from investigator.
• Generate MTA using UW provided Biomaterial Addendum.
• Expand if appropriate.
• Characterize and generate Certificate of Analysis.
• Generate Website listing
• Make materials and data available on website for order.
• Inform investigator that materials are available and provide direct link to materials.

For material you have assigned to WARF, WARF, not UW-Madison, has the authority through ownership to share the material. In these instances, the researcher should connect with their contact at WARF, or mta@warf.org, to coordinate the agreement around the distribution of the material to the recipient. WARF generally uses the UBMTA for such transfers, and it can be a quick and easy process for all involved.

Sharing material from human subjects requires a bit more care than sharing of other materials. With human subject material, UW-Madison has to make sure that the rights of the subjects or patients have been observed. This means ensuring that the material was acquired under proper IRB protocols, that informed consent was given, and that the informed consent covered the sharing. To help root out this information, RSP, the Office of Legal Affairs, and the IRB developed additional questions which have been included in the RAMP Agreement record for these types of materials. If the material to be shared was derived from human subjects under an approved IRB protocol or from patients for clinical purposes, RAMP will ask that these additional questions are answered at the time of record creation.

When material UW-Madison wishes to share is created using other materials, there may be obligations to the provider of the other material. In these instances, RSP will review the obligations (if any) that UW-Madison may have from the original provider to make sure UW-Madison doesn’t violate those other terms. Depending on the obligations, RSP may need to reach out to the original provider to ask permission or even tailor the Outgoing MTA to comply with the underlying obligations from the original provider. If the researcher already has permission to share from the original provider, it is helpful to have this documented from the provider and give this information to RSP to help streamline the process.

When the recipient of the material is a commercial entity, the expectations of the commercial entity may complicate UW-Madison’s ability to share the material. Quick discussions with both the commercial entity and the researcher can help us determine how best to handle the transfer. If the material is not related to a WARF patent or otherwise assigned to WARF, and the commercial entity only needs the material for limited internal research and not to commercialize products or services, we likely can use a modified version of the simple letter agreement or AUTM Toolkit MTAs. If the commercial entity requires broader rights to the materials or there is more value in the materials that should be returned to UW-Madison, UW-Madison will bring WARF into the mix to help with the licensing. If the researcher has a WARF contact, please let RSP know so RSP can coordinate with the researcher and WARF regarding how best to handle the transfer. Depending on the needs of the commercial entity (such as confidentiality), this agreement may not go through RAMP or RSP. A final determination will be made while coordinating with the researcher and WARF. If the materials are related to a WARF patent or otherwise assigned to WARF, WARF will handle the agreement around the transfer. Please inform your WARF contact of the request, or licensing@warf.org.

Basic agreement to accomplish the transfer of materials. Developed by NIH, this agreement is accepted by almost all universities. The agreement restricts the use of the materials to not-for-profit research purposes only, and prohibits redistribution of the material without the consent of the original provider. This agreement can be used to transfer any material that requires minimal protections.

• MTA - Simple Letter Agreement

Recognizing that there might need to be more protections for materials, the UBMTA provides additional terms to protect the rights of the providing institution. This agreement is used for the transfer of biological materials and requires both institutions to be signatories to the UBMTA Master Agreement. Once both institutions are signatories, this agreement to transfer materials is accomplished by both parties signing the implementing letter for the specific material transfer. This agreement can be used for the transfer of biological material where additional protections are needed. The UBMTA is only for transfers between non-profit/academic organizations.

• MTA - UBMTA Master Terms
• MTA - UBMTA Implementing Letter

While the UBMTA and Simple Letter Agreement are sufficient to transfer the vast majority of materials, some materials require special consideration. Transferring things such as chemicals often require more than the Simple Letter Agreement. And the UBMTA may not offer enough protection for sensitive materials, such as stems cells. Finally, the Simple Letter Agreement and the UBMTA were developed by NIH and are really aimed at domestic transfers. With universities operating on the global stage, additional templates are needed to do international transfers.

In order to accommodate these considerations, AUTM developed MTAs to address specific materials. These MTAs should be used for the specific material identified when additional protections are needed. They also should be used in instances where the University is transferring material outside of the US. The AUTM MTA templates are only for transfers between non-profit/academic organizations. They also allow for customization through additional terms.

• MTA - AUTM Biological
• MTA - AUTM Chemical
• MTA - AUTM Genetically Modified
• MTA - AUTM Human Tissue