Approval Milestones. Event Achieved by Licensed Product(s) 1st Major Indication (regardless of Profile) 1st Minor Indication (regardless of Profile) 2nd Major Indication (regardless of Profile) First to occur of 2nd Minor Indication or 3rd Major Indication (regardless of Profile) NDA filing with the FDA $[**] $[**] $[**] $[**] Regulatory Approval by the FDA $[**] $[**] $[**] $[**] for 2nd Minor Indication or $[**] for 3rd Major Indication NDA filing with the EMEA or an EU Major Market Country $[**] $[**] $[**] $[**] First Commercial Sale and/or receipt of Regulatory Approval in any three (3) EU Major Market Country(ies) $[**] $[**] $[**] $[**] for 2nd Minor Indication or $[**] for 3rd Major Indication Regulatory Approval by the MHLW in Japan $[**] $[**] $[**] $[**] for 2nd Minor Indication or $[**] for 3rd Major Indication The NDA filing milestones set forth in this Section 7.4.3 shall be payable only once for a Major Indication for each Regulatory Authority (i.e., either the FDA or the EMEA/EU Major Market Country) and only once for a Minor Indication for each Regulatory Authority regardless of the Profile. For the avoidance of doubt: in the event that an NDA is filed with the FDA in [**] in a Profile and a second NDA is filed with the FDA in [**] in another Profile, only one (1) FDA filing milestone shall be due. The Regulatory Approval milestones set forth in this Section 7.4.3 shall be payable only once for an Oncology Indication relating to [**] for each Regulatory Authority (i.e., either the FDA or the EMEA/EU Major Market Country or the MHLW in Japan) regardless of the Profile. For the avoidance of doubt:
Appears in 5 contracts
Samples: Collaboration Agreement, Collaboration Agreement (Discovery Partners International Inc), Collaboration Agreement (Discovery Partners International Inc)
