Material Communications. Without limitation of any other provision hereof (including Section 4.6), each party shall, within five (5) business days, provide notice to the other party of any material communications with any governmental agency concerning the Product in connection with any indication for which an NDA has been filed for the Product in the Territory, including, without limitation, Adverse Event reports and safety reports. Copies of all such material communications shall be attached to the notice sent pursuant to this Section 10.2. Notwithstanding the foregoing, in the event of a communication or directive from a regulatory authority commencing or threatening seizure of Product or *** CONFIDENTIAL TREATMENT REQUESTED.
Appears in 3 contracts
Sources: Development Agreement (Anthra Pharmaceuticals Inc), Development Agreement (Anthra Pharmaceuticals Inc), Development Agreement (Anthra Pharmaceuticals Inc)