Notice of Changed Regulatory Requirements. The Regulatory Lead Party shall provide notice to other Party of any additional requirements which the FDA may impose with respect to obtaining or maintaining Regulatory Approval for a Product (including additional clinical trials), and, within [****]* of receipt thereof by the Regulatory Lead Party, of all FDA inquiries with respect to a Product that require a response or for a which a response may be advisable.
Appears in 3 contracts
Samples: Collaboration Agreement (Facet Biotech Corp), Collaboration Agreement (PDL Biopharma, Inc.), Collaboration Agreement (Facet Biotech Corp)
Notice of Changed Regulatory Requirements. The Lead Regulatory Lead Party shall provide notice to the other Party of any additional requirements which the FDA may impose with respect to obtaining or maintaining Regulatory Approval for a Product for an Indication (including additional clinical trialsClinical Trials), and, within [****]* of receipt thereof by the Regulatory Lead Party, and of all FDA inquiries with respect to a Product that require or Agent requiring a response or for a which a response may be advisablewithin two (2) Business Days of receipt thereof by such lead Party.
Appears in 1 contract
Samples: Collaboration and Co Promotion Agreement (Medarex Inc)
