# Presentation: 212977

## Office of Technology Transfer and DevelopmentNational Institute of Diabetes and Digestive and Kidney DiseasesNational Institutes of Health and Department of Health and Human Services

**THE MATERIALS TRANSFER PROCESS**
**12 South Drive, MSC 5632, Bethesda, MD  20892-5632**
**Tel: (301) 451-3636 ****●  Fax: (301) 402-7462**
- _[http://](http://techdev.niddk.nih.gov/)__[TechDev.NIDDK.NIH.gov](http://techdev.niddk.nih.gov/)_

## Materials Transfer

***Material Transfer Agreement (MTA)***
- If exchange involves *ONLY* proprietary material (preferably not commercially available) from Industry, and resultant data from NIDDK/NIH, a ***materials CRADA*** may be appropriate
- If materials are transferred from NIDDK/NIH to Industry, a ***License*** may be required

**Notes:**
Even if the only contribution from the industry collaborator is a proprietary material or one that is otherwise unavailable commercially in the needed formulation, we can collaborate under a materials CRADA.  The materials CRADA has many of the same features of the full CRADA, but since the contemplated intellectual exchange is considerably simpler, the document can be as well.

When the intellectual exchange is simply a compound that may or may not be proprietary to a company, sometimes, a company will be willing to provide the compound for our research without the option for licensing developed technology.  When this is the case, and most investigators at NIH are familiar with the documents, we have the materials transferred under a Material Transfer Agreement or a Simple Letter Agreement.  These are generally used when exchanging materials with academia and other non-profits. 

## Material Transfer Agreements

- The MTA, or SLA, is intended to facilitate the free transfer of materials or information between investigators at NIDDK/NIH and those at other institutions, usually academic or non-profit
- Used when materials needed for recipient’s research and no collaboration is planned
- No rights in intellectual property are transferred

## Material Transfer Agreements

- For research purposes only
- May not be used in human subjects
- Material originating from humans must be identified and is subject to
- 45 CFR §46 (Protection of Human Subjects)

## Transfer: Simple Letter Agreement

- One-page agreement appropriate for transferring most materials
- 	between NIDDK/NIH and academia/non-profits - PHS Approved
- 	see _[http://](http://techdev.niddk.nih.gov/)__[techdev.niddk.nih.gov](http://techdev.niddk.nih.gov/)__[ ](http://techdev.niddk.nih.gov/)_at _[forms.htm](http://techdev.niddk.nih.gov/forms.htm)_ for agreement
- Can be modified by discussion with Technology Development
- 	Specialist at Office of Technology Transfer and Development
- 	for NIDDK:   (301) 451-3636
- 	see _[http://](http://techdev.niddk.nih.gov/)__[techdev.niddk.nih.gov](http://techdev.niddk.nih.gov/)__[ ](http://techdev.niddk.nih.gov/)_at _[staff.htm](http://techdev.niddk.nih.gov/staff.htm)_ for staff directory
- Must identify material(s) to be transferred
- Must be signed by Authorized Officials from both Institutions
- 	as well as the Recipient Scientist
- Two originals should be sent to NIDDK for signature

## Transfer:Material Transfer Agreements

- Agreement appropriate for transferring most materials
- 	see http://techdev.niddk.nih.gov at forms.htm for agreement
- Can be modified by discussion with Technology Development Specialist at Office of Technology Transfer and Development/NIDDK: (301) 451-3636
- Must identify material(s) to be transferred  (Separate MTA for mouse models)
- Must indicate whether materials were collected from human subjects (Paragraph 2(a)), and if so, identifies the assurance number
- Includes brief description of research plan involving the materials (Paragraph 3)
- Must be signed by Authorized Officials from both Institutions as well as the Recipient Scientist
- Two originals should be sent to NIDDK for signature

## Transfer:Uniform Biological Material Transfer Agreements

- NIH is a signatory to the UBMTA
- See AUTM (Association of University Technology Managers) for listing of non-profit organizations that have signed the Master Agreement, agreeing to accept the terms of the UBMTA
- Read UBMTA (cannot be modified).  It is accompanied by an Implementing Letter.
- Obtain UBMTA Implementing Letter for execution – identify materials, institutions see http://techdev.niddk.nih.gov at forms.htm
- Attach a brief description of research plan involving the materials
- Must be signed by both Provider and Recipient Scientists as well as the Authorized Official of the Recipient Institution
- Two originals should be sent to NIDDK for signature

## Licenses

- Transfers of materials to Industry are often accomplished
- 	by License
- Biological Materials License
- Commercial Evaluation License
- Internal Commercial Use License
- Non-exclusive and exclusive licenses of patented technology
- Model agreements are available at http://ott.od.nih.gov/NewPages/modagr.htm
- Licenses are negotiated with the
- 	NIH Office of Technology Transfer

## For Additional Information:

***Contact:***
**Office of Technology Transfer and Development**
**National Institute of Diabetes and Digestive and Kidney Diseases**
**12 South Drive, MSC 5632, Bethesda, MD  20892-5632**
**Tel: (301) 451-3636 ****●  Fax: (301) 402-7462**