Phase II Milestone Event definition

Phase II Milestone Event means the first dosing of a patient by or on behalf of Oragenics, or an Affiliate or permitted sublicensee of Oragenics, in a phase II clinical trial (as such is defined by relevant FDA guidelines) for a given Oragenics Product, irrespective of whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency.

Phase II Milestone Event means the earlier of (a) dosing of the last patient by or on behalf of Oragenics, or an Affiliate or permitted sublicensee of Oragenics, in a phase II clinical trial (as such is defined by relevant FDA guidelines, irrespective of whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency) for a given Oragenics Product, and (b) the twenty four (24) month anniversary of the dosing of the first patient in the phase II clinical trial. For purposes of this Section 1.58, the “dosing of the last patient” shall mean the last patient planned for under the JSC approved protocol (as such protocol may be amended and/or trial terminated during its implementation) for such phase II clinical trial having received his or her first dose.

Phase II Milestone Event. Section 1.59 of the Agreement “Phase IIb/III Milestone Event”, and Section 1.60 of the Agreement “Prior Field” are hereby deleted in their entirety and each replaced with “Reserved”.

Examples of Phase II Milestone Event in a sentence

• A second or a subsequent occurrence of the Phase II Milestone Event shall only give rise to an obligation upon Oragenics to make the payment to Intrexon under this Section 5.2(a)(i) if such respective second or subsequent occurrence of the Phase II Milestone Event occurs after the FDA has granted an approval to an FDA New Product Application for at least one Oragenics Product under the Program.

• Within thirty (30) days of the achievement of the Phase II Milestone Event (as defined in the Equity Agreement), Ampliphi will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) [*****] in cash, or (ii) the Phase II Milestone Shares (as defined in the Equity Agreement).

• Section 5.2(a)(i) of the Agreement is hereby replaced in its entirety with the following new Section 5.2(a)(i): Oragenics shall pay Intrexon a milestone payment of three million United States dollars ($3,000,000) within thirty (30) days of each achievement of the Phase II Milestone Event for each different Oragenics Product, said payment being made, at Oragenics’ option but subject to Sections 5.2(b) through 5.2(d), either in cash or in shares of Oragenics’ common stock.

• Within thirty (30) days of the achievement of the Phase II Milestone Event (as defined in the Equity Agreement), Ampliphi will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) two and one-half million dollars ($2.5M) in cash, or (ii) the Phase II Milestone Shares (as defined in the Equity Agreement).

More Definitions of Phase II Milestone Event

Phase II Milestone Event is the receipt by Borrower, in form and content reasonably acceptable to the Lenders, of positive overall survivability data in Borrower’s bavituximab second-line Phase II non-small cell lung cancer program.

Phase II Milestone Event means, for a given Collaboration Product, the enrollment of the first patient by or on behalf of Fibrocell, or an Affiliate or permitted sublicensee of Fibrocell, in a “phase II” clinical trial (as such is defined by relevant FDA guidelines, or, if the trial is conducted outside the United States, a substantially equivalent clinical trial) for a given Collaboration Product, irrespective of whether such occurs in the United States under the jurisdiction of the FDA or occurs elsewhere (including under the jurisdiction of a foreign regulatory agency).