Material Transfer Agreements

1. © 2007 ORPA Material Transfer Agreements What are they and why are they important?

2. First Things First! Who Are We? Gunta Liders Anne Corriveau Tammie Martin

3. What is an MTA? A Material Transfer Agreement (MTA) is a contract between the University of Rochester and a third party. This contract outlines the rights and responsibilities of the parties that arise due to the transfer and use of the materials.

4. A Contract!?! Who are the Parties? University of Rochester University policy dictates that research agreements must be signed by an authorized university representative Third Party- Industry Government or other Non-profit Academic

5. What’s in the 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 IP, discoveries, public disclosures, data

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 Want to be able to freely publish the results of the research, we will allow a brief review but will not allow 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. Talk about with Gunta - clarificationTalk about with Gunta - clarification

9. Other Significant Terms and Potential Issues… Previous Commitments Federal Grants- Under Federal law, we cannot assign our rights in the inventions and discoveries created with federal funds and in fact, the federal government retains an interest in these inventions. Industry Sponsored Research- may contain language that is significant to the research project you plan to use the materials in. MTAs- materials received under a previous MTA may prohibit combining the reagent with 3rd party materials, or sending to other institutions. Licensed Technologies

10. Other Significant Terms and Potential Issues… Intellectual Property (The BIG One!) As stated before, the MTA frequently includes terms regarding who will own what. As a research institution we want to avoid roadblocks to your future research. Such terms may include restrictions regarding new uses of the materials or substances created with the materials

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

12. Examples “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.” “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.” “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” Derivative" means material created from the Material that is substantially modified to have new properties such as, but not limited to, recombinant DNA clones made using a vector purchased from ATCC. Derivative" means material created from the Material that is substantially modified to have new properties such as, but not limited to, recombinant DNA clones made using a vector purchased from ATCC.

13. Examples “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”

14. 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 FY 2006 >450 agreements processed FY 2007 we have to date roughly 400 agreements, and the year is not yet over.

15. Process Submit appropriate checklist to ORPA along with copy of supplied MTA (if applicable) MTA Administrator will review request and agreement terms to ensure compliance with federal law and University Policy If necessary, MTA terms shall be negotiated to ensure compliance. Once finalized agreement is submitted for authorized signatures and finally sent to 3rd Party for execution.

16. What can I find more information? http://www.rochester.edu/ORPA/MatTransfer/index.htm http://www.cogr.edu/docs/Bayh_Dole.pdf http://www.autm.net/aboutTT/aboutTT_bayhDoleAct.cfm

17. Questions?