Common use of Clinical Milestones Clause in Contracts

Clinical Milestones. Event The First Profile to Achieve the Event The Second Profile to Achieve the Event Start of Phase I Study (first patient, first dosing) $[**] regardless of indication $[**] regardless of indication Start of Phase II Study (first patient, first dosing) $[**] for the first Major Indication $[**] for the first Major Indication Start of Phase II Study (first patient, first dosing) $[**] for the first Minor Indication $[**] for the first Minor Indication Start of Phase III Study (first patient, first dosing) $[**] for the first Major Indication $[**] for the first Major Indication Start of Phase III Study (first patient, first dosing) $[**] for the first Minor Indication $[**] for the first Minor Indication The Phase I Study milestone set forth in this Section 7.4.2 shall be payable only once for each Profile. All other milestones set forth in this Section 7.4.2 at each milestone event shall be payable only once for each Profile and only once for each Major Indication and Minor Indication, irrespective of Profile. For the avoidance of doubt: (a) in the event that a Phase II Study is commenced in [**] (a Major Indication) in two Profiles, only one (1) milestone shall be due; (b) in the event that a Phase II Study is commenced in [**] and in [**] (both of which are Major Indications) in the same Profile, only one (1) milestone shall be due; (c) in the event that a Phase II Study is commenced in [**] in the Bcl-2 Selective Profile and a Phase II Study is commenced in [**] in the Dual Profile, a Major Indication milestone for each shall be due; (d) in the event that a Phase II Study is commenced in [**] in the Bcl-2 Selective Profile (at which point the first Major Indication milestone is paid) and then a Phase II Study is commenced in [**] in the Bcl-2 Selective Profile (at which point no Major Indication milestone is paid) and subsequently to these two trials, a Phase II Study is commenced in [**] in the Dual Profile, then a second Major Indication milestone shall be due; and (e) in the event that the first Profile to be Developed by Novartis achieves the Phase I Study milestone and achieves the Phase II Study and Phase III Study Milestones for both a Major Indication and a Minor Indication, a total of $[**] shall be payable hereunder. If an NDA is filed after the end of a Phase II Study for a Licensed Compound, then the Phase III Study milestone event shall be deemed achieved as of the date of such filing.