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COVID-19 Expanded Access Template 

by Emily Chi Fogler, Kate Gallin Heffernan, Marylana Saadeh Helou

Published: March, 2020

Submission: March, 2020

 



We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements are not required to be and are not always documented in written agreements, there can be benefits to both parties (company and treatment provider) to memorializing the circumstances of the provision of an investigational drug.


To that end, we have created a simple Memorandum of Understanding template that may be useful to companies and providers seeking to document these arrangements quickly and efficiently in light of the current public health emergency. The template is intentionally streamlined and balanced, to capture the common denominator of terms that are often included in these agreements in a way that is reasonable for both parties. The template is drafted to focus on the provision of investigational drugs, as we understand drugs to be the primary expanded access treatment option at this stage of the pandemic. To the extent there is a demand for the expanded access use of investigational devices, this template can be modified (or we can tailor and re-circulate a device version). The template is also focused on the requirements for expanded access under the FDA’s regulations (21 C.F.R. § 312.300 et seq.) and would require modification for the provision of investigational drugs pursuant to the federal Right to Try Act.


Please note that this template is not intended as legal advice, and our circulation of this resource does not create an attorney-client relationship. We merely want to make as many tools available to the regulated community as we can during these challenging times.


Click here to download the Memorandum of Understanding template.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        


 



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