We advised Relief Therapeutics of the stability discrepancies in November and December 2020. In January 2021, we notified Relief Therapeutics that the formulation documented in the IMPD yielded only 60-day stability and began developing a longer stability product, ZYESAMI, aiming for a shelf life of at least one year. The Relief Agreement provides that Relief Therapeutics is to pay all costs of formulation, stability and CMC should such costs arise. Relief Therapeutics has declined to pay any of the costs associated with NRx’s development of ZYESAMI™ and has issued advice to its shareholders alleging that Relief Therapeutics owns all intellectual property related to ZYESAMI™. On April 19, 2021, Relief Therapeutics issued a press release acknowledging that “Relief notes that while there are stability issues with the formulation that Relief brought to the collaboration, all of these problems were understood by all parties at the time of the execution of the Collaboration Agreement and that efforts to resolve those issues were contemplated by the [Relief Agreement].” As of July 31, 2021, Relief Therapeutics has not funded any costs of re-formulation of aviptadil into a shelf stable product. There is no provision in the Relief Agreement that gives Relief Therapeutics access to development assets that Relief Therapeutics has not funded, nor does Relief Therapeutics own any patents that block NRx’s development of ZYESAMI™.
