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. 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. 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. 1. Cumulative Net Sales of Licensed Products first reaching **** ****
Milestone Milestone Payment. (i) Filing with the FDA of an Investigational New Drug application for the Combination Product $[**]
Milestone Milestone Payment. 1. First treatment of human subject in a clinical trial (i.e., first patient, first dose) [***]
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 $1,000,000
Milestone Milestone Payment. First filing of an IND for the first Licensed Product with either the FDA or EMEA [*] Fourth patient dosed with the first Licensed Product in a Phase I or I/II Clinical Trial [*] First patient dosed with the first Licensed Product in the first Phase III Clinical Trial or a Phase II Clinical Trial if such trial will be used as the registration trial. [*] First NDA or BLA submission for the first Licensed Product (US - FDA) [*] First MAA submission for the first Licensed Product (EMEA). [*] First calendar year in which aggregate worldwide Net Sales of a Licensed Product in such year reach fifty million U.S. dollars ($50,000,000) [*] First calendar year in which aggregate worldwide Net Sales of a Licensed Product in such year reach one hundred million U.S. dollars ($100,000,000) [*] Maximum Total Milestone Payments $ 13,650,000
