Investigational Drug Expanded Access Agreement

Summary

This template is an Investigational Drug Expanded Access Agreement designed for non-emergency situations in which a company engages with a research institution to supply an investigational drug for the treatment of a patient under the U.S. Food and Drug Administration (FDA) expanded access investigational new drug (IND) application regulations. This template includes practical guidance, drafting notes and optional clauses. This Investigational Drug Expanded Access Agreement identifies the responsibilities of the parties, transfer of the investigational drug, and ownership of intellectual property. This agreement is meant to be used only in non-emergency instances for expanded access. A protocol describing in detail the scope and nature of the treatment is typically attached as an exhibit and/or appendix to the agreement which is reflected in the current draft. This template is intended to be pro-company for single patient treatment and assumes the treatment will take place outside of a clinical trial. Under the FDA's current regulations there are only three categories of expanded access: • Individual patient usage, including emergency use (21 C.F.R. § 312.310) • Intermediate-size patient populations (21 C.F.R. § 312.315) –and– • Large patient populations under a treatment protocol or IND (21 C.F.R. § 312.320). Although this agreement contemplates usage with individual patients for non-emergency use, it may be modified for different patient group sizes. This agreement also assumes the institution has already submitted a Form FDA 3926 with the FDA requesting individual patient expanded access. For further discussion of the documentation to be submitted prior to or in conjunction with entering into this agreement, see 21 C.F.R. Part 312 Subpart I, which contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy. For the transfer of materials pursuant to a sponsored research relationship, use Sponsored Research Agreement (Pro-Grantee) and Sponsored Research Agreement (Pro-Supplier), and for the transfer of materials outside of a sponsored research context and under a variety of conditions, use Material Transfer Agreement (Pro-Provider) and Material Transfer Agreement (Pro-Recipient). This template is designed for the administration of the investigational drug outside of a clinical trial and sets forth the compliance responsibilities of the parties as enforced by the FDA. For more information about expanded access to experimental drugs see Right-to-Try and Expanded Access to Experimental Drugs and Right-to-Try and Expanded Access to Experimental Drugs Checklist.