Phase 3b Clinical Trial definition
Phase 3b Clinical Trial means a human clinical trial of the Licensed Product that (a) is voluntarily conducted after the filing with the FDA of the NDA for the Licensed Product but prior to obtaining Regulatory Approval of such NDA and (b) is not required or requested by the FDA as a condition of or in connection with obtaining such Regulatory Approval. For clarity, Phase 3b Clinical Trials shall be considered part of Commercialization.
Phase 3b Clinical Trial means, with respect to a Licensed Product for a given indication in a given country or jurisdiction, a clinical trial of such Licensed Product for such indication Initiated after submission of the MAA to the applicable Governmental Authority for the sale
Phase 3b Clinical Trial means, with respect to a Licensed Product for a given indication in a given country or jurisdiction, a clinical trial of such Licensed Product for such indication Initiated after submission of the MAA to the applicable Governmental Authority for the sale Amgen Ref. No. 2015641252 Page 15 of such product for such indication in such country or jurisdiction, but prior to receipt of Regulatory Approval for the sale of such product for such indication in such country or jurisdiction.