Termination in Connection With Additional Studies. If, pursuant to Section 4.8, the PDC does not receive the approval of the JEC to undertake the additional clinical studies required by the FDA within 90 days of making its formal recommendation of its conclusions to the JEC, then any Party may terminate this Agreement effective immediately upon giving the other Parties notice of such termination.
Appears in 4 contracts
Samples: Distribution and Supply Agreement, Distribution and Supply Agreement (Imclone Systems Inc/De), Distribution and Supply Agreement (Imclone Systems Inc/De)