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.
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.
Examples
These are some materials often transferred under an MTA:
Certain chemical compounds
Genetically altered mice
Animal models
Tissues (human or animal)
Sera
Plasmids
Compounds
Molecules
All agreements by BU with outside parties must be signed by an authorized (BU) institutional signatory. As a general matter, BU faculty members are not authorized signatories for BU.
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, etc. 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.
IACUC approval number if incoming material is a live animal.
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 Addgene MTA Request Form
Your completed Addgene MTA intake form is reviewed and there may be additional follow-up about MTA terms
Upon receipt of IBC approval and the Addgene MTA form, your Addgene order will be approved if there are no further questions or issues
Please contact industry@bu.edu 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?
BU encourages researchers to exchange non-hazardous or non-human research materials for non-profit, basic research purposes without a formal legal agreement, when practicable, subject to the following:
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/ dangerous material
…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 ASCThe 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
…recipient is not located in, or a citizen of, a sanctioned country,
andExport Control clears both the recipient entity and recipient PIPrincipal 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
…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)
…n/a
…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
Outgoing MTA requests are handled by the team in Technology Development (OTD). OTD relies upon the due diligence and written assurances provided by the requesting Principal Investigator as to all compliance matters, when drafting agreements. Outgoing MTA process:
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:
Institutional Review Board (IRB) / Office of Human Research Affairs (OHRA)
Export Control
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)
Depositing plasmids with Addgene requires an Addgene Deposit Agreement (ADA) instead of an MTA. Although Addgene does most of the work in preparing the ADA, OTD must do the requisite diligence before the ADA can be signed. Steps for an Addgene deposit:
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
If you are transferring animals
The title to the animal is an important consideration. Please review the background of the animal before submitting your MTA request. If the University does not own the animal, we must have an appropriate incoming MTA that permits the transfer of the animal to third parties. In some situations, even if the University has the title to the animal, there are restrictions on further transfers. These situations require negotiating a waiver of these obligations with the commercial vendor or third party the animal was acquired from.
If you are transferring human tissues
Human tissues require Institutional Review Board (IRB) review and approval. Please consult with the IRB with respect to the specific material transfer before submitting your request for a transfer of human tissues. If transfers are not clearly within the scope of a patient consent, the process of either interpreting the consent with respect to the contemplated transaction or obtaining a proper patient consent can be time consuming and can significantly delay the transfer of the material. Consulting with the IRB before submitting the MTA request allows the Technology Development team to simply confirm with the IRB that the transfer is permitted resulting in quicker processing of your MTA request.
