Material transfer agreements (MTAs) are agreements that establish the terms and conditions upon which proprietary materials are transferred by BU to outside parties, or received by BU from outside parties, for use by designated persons in specified and approved research protocols.
Why are MTAs important?
MTAs protect the intellectual property rights of Boston University, Boston University Medical Schools and/or Boston Medical Center in unique materials you have created. An MTA may also provide important protections against liability for the University and/or BMC with respect to the materials transferred.
What do MTAs do?
MTAs address both the manner and the scope in the following areas:
- Permitted use of the proprietary materials.
- Terms of the institution and the researcher’s publication rights with respect to the use of the proprietary materials.
- The respective intellectual property rights of the provider of, and the recipient of, the proprietary materials.
These are some materials often transferred under an MTA:
- Certain chemical compounds
- Genetically altered mice
- Animal models
- Tissues (human or animal)
As with other agreements with outside parties, an authorized institutional signature is required in addition to the signature of the PI/PD.
Incoming Material Transfer Agreements
Initiating an incoming material transfer agreement
Incoming MTAs govern the transfer of material from an outside organization into BU for research purposes. Examples of such research material include physical materials such as tissue samples, transgenic mice, cell lines, gene constructs, compounds, antibodies, as well as computer software and data. Please Note: Research material transferred under a MTA cannot be used in human subjects. If the material is a drug or a device that will be used in human subjects, please follow the procedures described for CTAs.
Incoming MTAs Instructions
- Complete the incoming MTA Form
- Your completed form is assigned to an industry contracting team member
- The industry contracting team member will confirm receipt and review the form and initiate the MTA process
- Please contact firstname.lastname@example.org if you do not receive a confirmation within 3 business days of submitting your incoming MTA Form
Other documents/information that may be required include:
- Institutional Biosafety Committee approval number
Researchers generally initiate an incoming transfer by obtaining a standard form from the transferring institution. The Sponsored Programs team handles incoming MTAs. As with other agreements, an authorized institutional signature is required in addition to the signature of the PI/PD. Where possible, the federally developed MTAs are used.
For some biological materials, there are generic terms that have been accepted by numerous Universities and other third parties. If the criteria are met, these transfers can be processed fairly quickly.
For Addgene MTAs
- Place your Addgene order online
- Once your Addgene order has been received by the industry contracting group, a team member will contact you to complete the incoming MTA Form
- Your completed MTA form is reviewed and there may be additional follow-up about MTA terms
- The industry contracting team member will contact the Institutional Biosafety Committee for approval
- Upon receipt of IBC approval and the MTA form, your Addgene order will be approved if there are no further questions or issues
- Please contact email@example.com if you do not receive a confirmation within 3 business days of submitting your Addgene order
Outgoing Material Transfer Agreements
Do I need an outgoing MTA?
- Outgoing MTAs are required when*:
- Sending human-derived biological material, tissue, fluids, specimens or samples of any kind for research purpose;
- Sending materials (including any component) received by BU from another party under an agreement which requires further action for transfer (e.g., another MTA, sponsored research agreement, purchase order, commercial purchase or other restrictive agreement which limits use or prohibits/limits further transfer of such material); or
- Sending materials when an MTA is otherwise legally required;
- Outgoing MTAs may be desired, e.g. when:
- Sending pre-published materials where intellectual property protection is being considered, but patents have not yet been filed (e.g., avoid inadvertent public disclosure); or
- BU’s Principal Investigator is sending materials to a Recipient with restrictions, e.g., limitations on use and further transfer;
- BU’s Principal Investigator wishes the lab to be reimbursed for costs of preparation and distribution of those materials taking into account Program Income requirements for federal research grants.
*The University Principal Investigator, per the Responsible Conduct of Research Policy, is responsible for the compliance with the legal, regulatory, and ethical requirements established by the University, regulatory agencies, funding sources and professional organizations including with respect to MTAs:
- Investigating and identifying limitations, requirements, restrictions or hazards applicable to the material; and
- Obtaining any review and approvals necessary for the transfer of materials (e.g., IRB, ASC, OEHS, Export Control, or third party permission – including funders, providers, vendors and recipients, etc.)
The Industry Contracting Group and Technology Development rely upon the due diligence and written assurances provided by the University Principal Investigator as to all compliance matters, when drafting agreements.
The Outgoing MTA Guidelines in the next collapsible box highlight the most common factors and prerequisite conditions in determining the University’s right to transfer the material, as well as the factors determining whether a signed MTA is required. The table also provides guidance on preliminary steps the sender PI can take to expedite any requested material transfer.
Outgoing MTA Guidelines
|If…||BU can transfer the material if…||A signed MTA is…||Prior to completing MTA request, PI should…|
|…the material is human-derived biological material, tissue, fluids, specimens, or samples||…IRB approves the transfer under the applicable IRB protocol||…always needed||…obtain explicit IRB approval for the requested transfer|
|…the material is hazardous/|
|…OEHS approves the transfer under the applicable shipping protocol||…typically not needed||…confirm with OEHS on requirements for proper shipping / handling of Material|
|…the material is live animal specimens||…the The Animal Science Center manages and oversees animal-relate... approves the transfer||…typically not needed unless specimen is derived from 3rd party material (see below)||…obtain ASC approval for the requested transfer|
|…the material is a modification or derivative of, or includes any third party material||…there is no agreement (e.g. inbound MTA, SRA, purchase order, etc.) governing the use of the 3rd party material,|
or if there is such an agreement, but there are no prohibitions or restrictions on further transfer,
or if there is such an agreement and there are such restrictions, and BU obtains the necessary approval from the 3rd party to further transfer the material
|…needed if so required by the terms of the agreement governing the use of the 3rd party material||…identify and locate any inbound MTA, purchase order, SRA, etc. that accompanied the sender’s receipt of the 3rd party material|
|…the material is being sent to a foreign recipient (including foreign recipient PI at domestic institution)||…recipient is not located in, or a citizen of, a sanctioned country,|
and no Dept. of Commerce “red flags” are present
and Export Control clears both the recipient entity and recipient Principal Investigator View Boston University's policy on...
|…n/a||…contact Export Control to request screening of recipient entity and recipient PI|
|…the material is being sent to a foreign recipient (including foreign recipient PI at domestic institution)||…the Material is not controlled under the Commerce Control List or the US Munitions List,|
or if the Material is controlled, and an Export License is obtained
|…needed if the transfer requires and is subject to an Export License||…contact Export Control to request proper Export Control assessment of Material performed|
|…the material is pre-publication where IP protection is being considered, but patents have not yet been filed e.g., to avoid inadvertent public disclosure||…n/a||…always needed|
(to stipulate obligation of confidentiality)
|…the sender wants to specify obligations regarding results of the recipient’s research, publication, attribution, etc.||…n/a||…always needed||…determine what special terms to include in MTA|
|…the sender requires recipient to pay a fee to cover the cost of preparation and distribution of the material||…n/a||…always needed||…determine the appropriate MTA fee|
|…the sender wants to restrict recipient’s use of the material in any way, including further transfer||…n/a||…always needed||…determine what specific restrictions to include in MTA|
|…the recipient institution requires a signed agreement||…n/a||…always needed||…n/a|
Outgoing MTA Instructions
- Complete the Outgoing MTA Request Form and hit the “Submit” button at the end of the form
- The completed form is assigned to an OTD team member
- OTD will confirm receipt and review the form and initiate the MTA process
- Please contact OTD if you do not receive a confirmation within 3 business days of submitting and Outgoing MTA request
- Based on answers to questions in the form, the following groups may also receive notification of the request and could contact you directly regarding the request:
- Environmental Health & Safety (EHS)
- Institutional Review Board (IRB) / Office of Human Research Affairs (OHRA)
- Export Control
- Institutional Animal Care & Use Committee (IACUC) / Animal Science Center (ASC)
Outgoing MTAs are generally initiated by OTD. OTD will determine the appropriate form of MTA. For some biological materials, there are generic terms that have been accepted by numerous Universities and other non-commercial third parties. If the criteria are met, these transfers can be processed fairly quickly. Please see the AUTM Universal Biological MTA site for a discussion of when this process can be used.
For Addgene MTAs (Deposit Agreements)
- Complete the Addgene deposit process
- Addgene will prepare and send an ADA to OTD for signature
- Complete the Outgoing MTA Request Form
- To expedite the process, the PI should do this as soon as possible
- If this has not been done when OTD receives the ADA from Addgene, OTD will contact you to complete this request form
- Your completed request form is reviewed and there may be additional follow-up to address any diligence issues
- Once any diligence issues are resolved, OTD will forward the ADA for University signature