Milestone Milestone Payment. 6. The Filing of a BLA with the FDA for a Product for the first Indication $*** $***
Milestone Milestone Payment. 1 Achievement of Development Candidate One Million Dollars ($1,000,000) #2 First dosing of a human patient in a Phase I Trial Two Million Dollars ($2,000,000)
Milestone Milestone Payment. 1. Cumulative Net Sales of Licensed Products first reaching **** ****
Milestone Milestone Payment. Acceptance by the FDA of a PTB NDA or a PTB Supplemental NDA filed by or on behalf of Seller or Buyer with the approval of the Joint Development Committee (the “PTB NDA Acceptance Milestone”) U.S. $5,000,000 (“PTB NDA Acceptance Milestone Payment”) First commercial sale of a PTB Product by or on behalf of Buyer in the U.S. (the “PTB Product Launch Milestone”) U.S. $30,000,000 (“PTB Product Launch Milestone Payment”)
Milestone Milestone Payment. Territory-wide Net Sales of Products in a calendar year of at least $[***] [***] Territory-wide Net Sales of Products in a calendar year of at least $[***] [***] Territory-wide Net Sales of Products in a calendar year of at least $[***] [***]
Milestone Milestone Payment. (i) Filing with the FDA of an Investigational New Drug application for the Standalone Product $[**]
Milestone Milestone Payment. (a) The earlier of (i) first patient dosed in the first FDA accepted pivotal (i.e., used for registration purposes in the Territory) Phase III clinical study wherever located or (ii) first patient dosed after designation of a Phase II clinical study as a FDA accepted pivotal Phase III clinical study wherever located used for registration purposes in the Territory. USD $ [***]
Milestone Milestone Payment. 1. First treatment of the 1st human subject in a clinical trial (i.e., first patient, first dose) $****
Milestone Milestone Payment. First New Drug Approval in *** for the treatment of secondary hyperparathyroidism in *** patients with vitamin D insufficiency *** First New Drug Approval in *** for the treatment of secondary hyperparathyroidism in *** patients with vitamin D insufficiency *** First New Drug Approval in *** for the treatment of secondary hyperparathyroidism in *** patients with vitamin D insufficiency *** First New Drug Approval in *** for the treatment of secondary hyperparathyroidism in *** patients with vitamin D insufficiency *** First Commercial Sale in ***. *** *** ***; and ***, then the milestone owed and payable to OPKO will be equal to that corresponding pro rata percentage *** between *** and *** that is obtained. For example, *** obtained is ***, OPKO shall be entitled to a *** milestone payment of ***. *** per day. For the avoidance of doubt, OPKO shall be entitled to receive the milestone payments described herein based on *** irrespective of any additional dosage provided in a ***.
