Compassionate Use. Promptly after the Pre-Registrational Meeting with the FDA, EMA, and PMDA for a particular Product (or in the case in which a Product is only being developed for the US or the EU, but not both, after the applicable FDA, EMA or PMDA Pre-Registrational Meeting) or at a time otherwise agreed by the Parties, the JRDC shall decide on a procedure for managing Product requests for compassionate use.
Appears in 2 contracts
Sources: Collaborative Research, Development and Commercialization Agreement (Revolution Medicines, Inc.), Collaborative Research, Development and Commercialization Agreement (Revolution Medicines, Inc.)