Communication with Regulatory Agencies. If a Party is contacted by the FDA or any equivalent regulatory agency in any country in the Territory during the Term pertaining to this Agreement or to a Product, Tularik and JT shall promptly, but always within [ * ] days, notify and consult with one another. The Party that has filed the Drug Approval Application in such country within the Territory or, if no Drug Approval Application has been filed, the Party which has filed the IND (or foreign equivalent) in such country within the Territory shall provide an appropriate response to such contact after such consultation with the other Party.
Appears in 8 contracts
Samples: Preliminary Research, Development and Marketing Agreement (Tularik Inc), Preliminary Research, Development and Marketing Agreement (Tularik Inc), Preliminary Research, Development and Marketing Agreement (Tularik Inc)
