Each access plan will be unique to the technology being developed and we encourage licensees to provide information and identify access strategies that make sense for them and their products. 

NIH provides these samples for educational purposes to demonstrate how access plans could be prepared in different contexts and conform to the requirements of the IRP Access Planning Policy. These samples are not intended to be used as a template, and their use does not guarantee approval by NIH. 

The technology described in these plans is hypothetical and does not intentionally reflect any current or former NIH license. The samples stand alone, outside the context of a full license or application, but applicants may cross-reference information from other parts of their application in their access plan. These samples reflect an access plan prepared before FDA approval of the licensed product (or a foreign equivalent). NIH would maintain the confidentiality of such an access plan, along with other license information and reports, as permitted by applicable law.

The information and strategies mentioned in these samples give a non-limiting example of what may be included in an access plan, and they may assist license applicants and licensees: 

• Sample plan from an established company seeking an exclusive license to develop an adoptive cell therapy
• Sample plan for a non-exclusive license to develop a rapid diagnostic for Lyme disease

You may also want to consult these resources: 

• Points to Consider & Potential Strategies to Include when Drafting an Access Plan (Section E of the policy implementation guidance)
• NCATS Toolkit for Patient-Focused Therapy Development
• NIH SEED Office Product Development Support