# Presentation: 301131

## NCI Technology Transfer Branch:RAID, Intellectual Property, and Technology Transfer Agreements

**Donna L. Bialozor**
- Technology Transfer Branch
- Office of the Director
- National Cancer Institute

## NCI Technology Transfer Branch

**How does NCI Technology Transfer Branch support the  NCI RAID Program?**

## NCI Technology Transfer Branch

- To ensure technology development activities comport with Federal statutes, regulations and the policies of the National Institutes of Health.
- Negotiation of transactional agreements between the NCI and outside parties

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Focusing on Negotiation of transactional agreements between the NCI and outside parties

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

**Transactional Agreements**
- RAID Material Transfer Agreements
- Confidential Disclosure Agreements

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- How information in the Intellectual Property Report Form relates to negotiation of Transactional Agreements

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Why is this form important to both the University and the NCI?

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Gives an idea about  Freedom to Operate

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

**Intellectual Property Report Form**
- Brings Attention to Unique Circumstances

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Means of communication between:
- RAID PI and University Technology Transfer Office

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Means of communication between:
- University Technology Transfer Office and NCI Technology Transfer Branch

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Means of communication about:
- Third Party Agreements connected with the RAID Project

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Incoming (NCI Recipient)
- Outgoing (NCI Provider of research grade materials)
- Outgoing with Clinical Addendum (NCI Provider of clinical product for human clinical studies)

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Incoming (NCI Recipient)
- Articles 7 & 8
- NCI Contractor and Subcontractor Involvement
- Management of New Inventions

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Outgoing (NCI Provider of Research grade Materials)
- Article 1 - permits sharing of Materials and data with a third party in compliance with terms of NCI RAID MTA.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Outgoing (NCI Provider of Research grade Materials)
- Article 3 – Acknowledgement of NCI RAID Support.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Outgoing (NCI Provider of Research grade Materials)
- Article 8 – Sharing of results and publications with NCI prior to disclosure.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Outgoing with Clinical Addendum
- NCI Cancer Therapy Evaluation Program, Regulatory Affairs, involved in negotiation of Clinical Product MTA.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Outgoing with Clinical Addendum
- Article 11 c – Copy of FDA letter that IND has been filed must be sent to NCI prior to shipment of Clinical Material.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Outgoing with Clinical Addendum
- Article 12 – Agree to   provide NCI with copy of Annual Reports to FDA.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Most commonly entered into when the University partners with a commercial entity during conduct of the RAID Project.

**NCI Technology Transfer Branch**

## NCI Technology Transfer Branch

- Main Office:
- Technology Transfer BranchNational Cancer Institute6120 Executive Blvd. Suite 450Rockville, MD 20852Phone:  301-496-0477

- Frederick Office:
- Technology Transfer BranchNCI-Frederick1003 West 7th Street, Suite 500 Frederick, MD 21701Phone:  301-846-5465

**Contact Information**

**NCI Technology Transfer Branch**