Current NIH Policies & Guidelines Related to Technology Transfer 

• PHS Technology Transfer Policies and Procedures Manual
• NIH Ethics Program and Resolving Conflicts of Interest
• NIH Data Management and Sharing Policy
• NIH Research Tools Policy
• NIH IRP Access Planning Policy
• NIH Grants & Funding Intellectual Property Policy
• Best Practices for the Licensing of Genomic Inventions - Final Notice (April 2005)

USG Reports & Public Engagement 

• Webinar on Draft NIH Intramural Research Program Policy: Promoting Equity through Access Planning, 2024
• Workshop on Transforming Discoveries into Products: Maximizing NIH's Levers to Catalyze Technology Transfer, 2023
• NIST Report NIST GCR 20-025, David P. Leech and John T. Scott, Federal Agency Return on Investment in Foreign Patenting, April 2021
• NIST Report: Return on Investment Initiative, April 2019 (“Green Paper”)
• SACGHS Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests, 2010
• Article: Barbara M. McGarey and Annette C. Levey, Patents, Products, and Public Health: An Analysis of the CellPro March-In Petition, 14 Berkeley Technology Law Journal, 1095, (1999)
• Reports of the NIH Panels on CRADAs: Perspectives, Outlook, and Policy Development, 1994
• NIH Notice Rescinding Reasonable Pricing Clause, 1995
• The NIH Experience with the Reasonable Pricing Clause in CRADAs FY1990-1995
• Panel Report of the Forum on Sponsored Research Agreements: Perspectives, Outlook, and Policy Development
• Uniform Biological Material Transfer Agreement: Discussion of Public Comments Received; Publication of the Final Format of the Agreement, 1995
• HHS OIG Report OEI-01-92-0110 -- Technology Transfer And The Public Interest: Cooperative Research and Development Agreements at NIH (November 1993)
• Federal Laboratory (Interagency) Technology Transfer Summary Reports

NIH Contributions to WHO COVID-19 Technology Access Pool

• NIH Makes COVID-19 Technologies Available to Global Manufacturers Through WHO Program
• NIH Contributions to WHO COVID-19 Technology Access Pool

Court Cases

• Public Citizen Health v. National Institutes of Health
• University of South Florida v. National Institutes of Health (originally the Jackson Laboratory)

NIH Research Tools Guidelines

• Research Tools – NIH Principles and Guidelines for Sharing of Biomedical Resources – Final (Published in the Federal Register on Thursday, December 23, 1999, Vol. 64 No. 246, pp. 72090-72096)

Memoranda of Understanding

• NIH/DuPont OncoMouse Memorandum of Understanding
• NIH/DuPont Crelox Memorandum of Understanding
• PHS/WiCell Amended and Restated Memorandum of Understanding
• PHS/WiCell Amended and Restated Memorandum of Understanding - Simple Letter Agreement

NIH March-In Response

• HHS Response to Appeal Request of Xtandi March-In Request (2024)
• NIH Decision on Xtandi March-In Request (2023)
• NIH Decision on Xtandi March-In Request (2016)
• March-In Determination in the case of Fabrazyme
• Fabrazyme March-In Close-Out Letter (February 2013)
• March-In Position Paper in the case of Xalatan
• March-In Position Paper in the case of Norvir
• NIH Public Meeting in the case of Norvir (May 25, 2004)
• March-In Determination in the case of Norvir (November 2013)
• March-In Determination in the case of CellPro

Congressional Interest in NIH Technology Transfer

• GAO Report GAO-23-105656 -- Better Data Will Improve Understanding of Federal Contributions to Drug Development (2023)
• GAO Report GAO-21-272 -- Biomedical Research: Information on Federal Contributions to Remdesivir (March 2021)
• GAO Report GAO-21-52 -- Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property (October 2020)
• GAO Report GAO-09-742 – Information on the Government's Right to Assert Ownership Control over Federally Funded Inventions (July 2009)
• Report to Congress on Affordability of Inventions and Products (July 2004)
• NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' Interests are Protected (July 2001)
• GAO Report RCED-99-242 – Technology Transfer: Reporting Requirements for Federally Sponsored Inventions Need Revision (August 1999)
• GAO Report RCED-99-173 – Technology Transfer: Number and Characteristics of Inventions Licensed by Six Federal Agencies (June 1999)
• GAO Report - Problem Areas Affecting Usefulness of Results of Government-Sponsored Research in Medicinal Chemistry (1968)