nci technology transfer branch: raid, intellectual property, and technology transfer agreements

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNATIONAL INSTITUTES OF HEALTH

Working with FDA:Biological Products and Clinical Development

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNATIONAL INSTITUTES OF HEALTH

Working with FDA:Biological Products and Clinical Development

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

Donna L. BialozorTechnology Transfer BranchOffice of the DirectorNational Cancer Institute

Working with FDA: Biological Products and Clinical Development Donna Bialozor

NCI Technology Transfer Branch

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


Support the National Cancer Institute's technology development activities

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 Branch Support to RAID

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



Transactional Agreements

RAID Material Transfer Agreements

Confidential Disclosure Agreements



NCI Technology Branch Support to RAID

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



Intellectual Property Report Form

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




Gives an idea about Freedom to Operate




Brings Attention to Unique Circumstances




Means of communication between:

RAID PI and University Technology Transfer Office




Means of communication between:

University Technology Transfer Office and NCI Technology Transfer Branch




Means of communication about:

Third Party Agreements connected with the RAID Project



RAID Material Transfer Agreements Incoming (NCI Recipient)

Outgoing (NCI Provider of research grade materials)

Outgoing with Clinical Addendum (NCI Provider of clinical product for human clinical studies)



RAID Material Transfer Agreement Incoming (NCI Recipient)

• Articles 7 & 8

– NCI Contractor and Subcontractor Involvement

– Management of New Inventions



RAID Material Transfer Agreements 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.




grade Materials)

• Article 3 – Acknowledgement of NCI RAID Support.




grade Materials)

• Article 8 – Sharing of results and publications with NCI prior to disclosure.



RAID Material Transfer Agreements Outgoing with Clinical Addendum

• NCI Cancer Therapy Evaluation Program, Regulatory Affairs, involved in negotiation of Clinical Product MTA.




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




• Article 12 – Agree to provide NCI with copy of Annual Reports to FDA.



Confidential Disclosure Agreements Most commonly entered into when the

University partners with a commercial entity during conduct of the RAID Project.



Web Address: http://ttb.nci.nih.gov/

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: raid, intellectual property, and technology transfer agreements

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