Material Transfer Agreements

1. Material Transfer Agreements What are they and why are they so important? Jan Dowdle Thornton Office of Technology Transfer Auburn University ALABAMA RESEARCH SYMPOSIUM APRIL 29, 2010

2. What is an MTA? • Material Transfer Agreement – MTA: Agreement or contract that governs the transfer of tangible research materials between organizations and outlines the rights and responsibilities of each party. • Academic  Academic • Academic  Industry • Industry  Academic

3. Why do we transfer materials? • Foster scientific collaboration • Comply with NIH guidelines, federal statutes and publication requirements • Facilitate licensing • Encourage industry sponsored research

4. Material Transfer Agreements are: • Fundamentally a Confidentiality Agreement • Disclosure of information and • Provision of biological material • Owner provides material and information • Recipient receives material and information • Similar obligations to a Confidentiality Agreement • Secrecy • Use only for certain purposes

5. So what’s in this contract? • The MTA will dictate how the materials, and the results from using the materials can be used, along with other significant terms, conditions and obligations. • What are the “Results”: • Encompasses a fairly broad range of items • Results = IP, discoveries, public disclosures, data, observations

6. So why is the MTA important? • The definitions, terms and conditions within the contract can affect the future of your research and your ability to publish. • Without an MTA, the recipient of the material has free rein over use and further distribution of the materials. • The provider is giving away the materials if an MTA is not in place.

7. Other Significant Terms and Potential Issues… • Definitions • How the materials are defined may significantly impact the terms within the agreement. • Publication Procedures • You will want to be able to freely publish the results of the research, so allow a brief review but not editorial rights • Confidentiality Obligations • Frequently, the definition of “confidential information” will include the research results, including the data. If a specific carve out is not included for publication purposes, you will not be able to publish.

8. Other Significant Terms and Potential Issues… • Indemnification Issues • If the MTA is not properly reviewed, negotiated and signed, the PI or University may be subject to increased liability. • Export Controls • If the materials are either being received from, or shipped to a foreign country, an export control license may be necessary. If in violation, the signatory shall be personally responsible and subject to fines, and both civil and criminal penalties.

9. Other Significant Terms and Potential Issues… • Previous Commitments • Federal Grants • Industry Sponsored Research • MTAs • Licensed Technologies The burden is on the recipient to ensure that any grant of rights to the provider of the Material does not conflict with any contractual obligations to 3rd parties, existing or future, including the Government.

10. Other Significant Terms and Potential Issues… • Intellectual Property • The MTA frequently includes terms regarding who will own what. You will want to avoid roadblocks to your future research. • Terms may include restrictions regarding new uses of the materials or substances created with the materials.

11. Examples of MTA Terms • “Publication of Research results by the Investigator shall only occur after initial publications authored by the internal Provider scientists.”

12. Examples of MTA Terms • “Recipient Scientists may publish or otherwise publicly disclose the results of the Research Project provided that the draft manuscript of such publication or public announcement has been reviewed and approved by Provider”

13. Examples of MTA Terms • “The Purchaser shall not distribute, sell, lend or otherwise transfer the Material or Replicates for any reason. Any commercial use of the Material, Replicates, and Derivatives is prohibited without prior written authorization.”

14. Examples of MTA Terms • “Any Inventions, whether made solely by Recipient and/or Investigator, solely by Provider, or jointly by Recipient and/or Investigator and Provider, shall be solely owned by Provider. Recipient and/or Investigator shall assign any and all of their rights, title, and interest in Inventions to Provider.”

15. Examples of MTA Terms • “The parties agree that know-how, inventions, data and other intellectual property generated by the Recipient and Investigator pertaining to the material will be the property of Provider.”

16. Examples of MTA Terms • “All the data, results, information and any intellectual property relating hereto or arising here from and all inventions, patentable or not, ... resultant patents made or obtained in relation hereto shall be the exclusive property of Provider. As sole proprietor of such data and results, Provider shall be free to use and exploit such results at its discretion.”

17. Why does it take so long! • Typically, MTAs with industry take the longest. This is often because these agreement contain many of the “hotspots” we just reviewed and therefore they must be negotiated. • Within the academic and non-profit community, there are several standard agreements that have been drafted to facilitate transfers. • UBMTA • Simple Letter Agreement

18. Summary of Potential Pitfalls of Incoming Agreements • Freedom to publish • Ownership Data Inventions, Intellectual Property • Conflicts with sponsored research • Reach through royalties and compelled licenses

19. Before transferring materials… • Consider: • Whether the University has the clear right to transfer the Material, or if it is restricted by existing contractual obligations to a third party. • Potential commercial value of the Material.

20. Before receiving materials… • Consider: • How IP terms might impact your present and future research and licensing opportunities. • Whether or not there are alternative sources of the material that might not have strings on its use.

21. QUESTIONS???