What is a Material Transfer Agreement?
Material transfer agreements (MTAs) are legal contracts that govern the transfer of tangible research materials between two organizations
What is a Material Transfer Agreement?
A Material Transfer Agreement (MTA) is a legal contract that governs the transfer of tangible research materials between two organizations, often academic institutions, research organizations, or companies. It specifies the terms and conditions under which the recipient can use the materials. Researchers and organizations frequently use MTAs in scientific research and development, especially in fields like biotechnology, pharmaceuticals, and life sciences.
Key Points of an Material Transfer Agreement:
1. Parties Involved
MTAs typically involve a provider (who owns or controls the material) and a recipient (who wants to use the material for research or development).
2. Material Definition
The agreement clearly defines the materials being transferred, which can include biological materials (like cell lines, plasmids, or DNA), chemical compounds, or other research tools.
3. Purpose of Use
The MTA specifies how the recipient can use the materials. This may be restricted to research purposes. There may be restrictions on whether the following uses are allowed: use for genetic testing, use in animal models, to provide a commercial service, or to offer a commercial product.
4. Ownership
The provider retains ownership of the materials. In addition, any derivatives or modifications of the materials may also be subject to ownership or usage restrictions.
5. Confidentiality
The agreement often includes clauses to protect confidential information shared alongside the material.
6. Publication Rights
The MTA may outline terms regarding whether the recipient can publish results obtained using the material. For instance, provisions might allow the provider to review and approve publications to protect proprietary information.
7. Liability and Indemnification
MTAs address liability issues, stating that the provider does not guarantee the quality of the materials. Moreover, the recipient often assumes responsibility for any damages or claims resulting from their use.
8. Intellectual Property (IP)
MTAs frequently outline how any intellectual property arising from the research using the material will be handled. The provider may claim ownership of certain inventions or request licensing rights.
MTAs play a crucial role in protecting the interests of both parties while facilitating collaboration and sharing materials vital to research advancements.
Best Practice
- An MTA or similar agreement should be executed to document the obligations and responsibilities of parties involved in the transfer of materials from a repository prior to shipment. The agreement should be in place before the transfer occurs.
- Repositories that receive or send material should have an MTA and maintain documentation for such transactions. Repositories should have templates of this document that can be used or modified as needed.
- Repositories should execute an MTA that incorporates terms for data transfer or similar agreement with recipients who receive specimen-associated data from the repository.
ISBER Best Practices
Webinar: Aligning Industry’s and Academia’s Interests
In this talk, Donna Wren, Associate General Counsel at Synthego Corporation, discusses the complexities of handling human biological specimens (HBS) between academic institutions and industry, focusing on the role of Material Transfer Agreements (MTAs). The talk was given in a Biosample Hub webinar, on the 16th December 2022.
Summary of the key points
1. Introduction
Donna shares her experience in the life sciences industry, noting that she regularly works with HBS in the gene editing space at Synthego. She emphasizes the significance of balancing the interests of for-profit companies and nonprofit institutions, like universities and biobanks, when transferring HBS.
2. Polling Question
Donna initiates a poll to gauge the audience’s understanding of the most significant concerns in transferring HBS between academic institutions and companies. She highlights that compliance with informed consent and Institutional Review Board (IRB) approval are crucial concerns for both parties.
3. What an Material Transfer Agreement Is Not
MTAs are legal agreements that govern the transfer of materials between institutions, ensuring proper documentation and defining the scope of usage. They should not be used as collaboration or licensing agreements. MTAs must clearly define what materials are being transferred, their quantities, and the intended use.
4. Different Objectives of Academia and Industry
Academic institutions prioritize knowledge sharing, advancing research, and societal benefits. Industry, on the other hand, focuses on commercial interests, such as developing therapies and attracting investors. Both parties often differ in their views on the rights to the results and intellectual property generated from HBS.
5. Key Issues in MTAs
- Research Use vs. Commercial Use: Academic institutions often impose strict limitations on the use of HBS for research purposes only, while companies seek broader rights to use the materials for product development and commercialization.
- Third-Party Sharing: Industry often needs to collaborate with third-party service providers (such as Contract Research Organizations, or CROs) to carry out research, which can complicate MTA terms.
- Intellectual Property (IP) Rights: The talk explores the challenges of determining who owns the IP generated from the research, with academic institutions seeking access to results for furthering research, while companies aim to retain ownership for commercial purposes.
6. Informed Consent and Privacy Issues
Academic institutions bear the responsibility of obtaining appropriate informed consent from donors before transferring HBS to companies. Compliance with privacy laws, such as GDPR and state laws, becomes critical when dealing with phenotypic data.
7. Challenges and Best Practices for MTAs
Developing a template for MTAs is challenging because different scenarios, such as working with CROs or direct research, require flexibility. Open communication between parties is encouraged to resolve issues efficiently.
8. Conclusion
Donna concludes by emphasizing the importance of collaboration between academia and industry to further research and development, while ensuring legal and ethical compliance in the transfer and use of HBS.
Disclaimer: The information provided in this video does not, and is not intended to, constitute legal advice; instead, all information, content, and materials presented in the video are for general informational purposes only. Viewers should contact their attorney to obtain advice with respect to any particular legal matter.
Useful References
Use and Misuse of Material Transfer Agreements: Lessons in Proportionality from Research, Repositories, and Litigation. Bubela et al. PLoS Biol 13(2): e1002060. doi:10.1371/journal.pbio.1002060 (2015).
International Charter of principles for sharing bio-specimens and data. Mascalzoni et al. Eur J Hum Genet. 23, 721–728 (2015).
Drafting biological material transfer agreement: a ready-to-sign model for biobanks and biorepositories. Cervo et al. Int J Biol Markers 31, e211 – e217 (2016)
Provenance and risk in transfer of biological materials. Nielsen et al. PLoS Biol 16, e2006031. https://doi. org/10.1371/journal.pbio.2006031 (2018)
Protecting participants in health research: The South African Material Transfer Agreement. Labuschaigne et al. S Afr Med J, 109, 353-356 (2019).
