Phase II Completion definition
Examples of Phase II Completion in a sentence
If AMANO decides not to act as primary manufacturer of Materials following Phase II Completion, ALTUS shall be forced to cease using AMANO as the primary manufacturer of Materials and engage an alternative primary manufacturer to carry out manufacture of Materials.
If AMANO decides to act as primary manufacturer of Materials following Phase II Completion, the parties shall proceed to negotiate in good faith a Manufacturing Agreement governing the manufacture and supply of Materials to be used by ALTUS in Phase III and/or the commercial manufacture and supply of Materials by AMANO.
If ROCHE does not pay the Option Extension Fee with respect to a Product, there shall be no additional option with respect to that Product beyond that associated with the Phase II Completion Date.
The Party taking the lead with respect to a particular regulatory filing hereunder (each, the “Lead Regulatory Party”) shall be Alnylam through First Phase II Completion and Roche thereafter, unless and until either Party exercises its Opt-Out Right, in which case the Continuing Party shall be the Lead Regulatory Party.
The Business Plan accurately specifies, to the best of the Borrower's knowledge, all costs and expenses incurred and anticipated to be incurred prior to the date on which a Phase I Completion Certificate and a Phase II Completion Certificate will have been issued.
If AZ fails to provide an Election Notice to ABX for a Candidate Drug that binds to and is directed against a Collaboration Antigen, within [Confidential treatment requested] after the first Phase II Completion for a Candidate Drug that binds to and is directed against such Collaboration Antigen, or such longer period as the Parties mutually agree in writing, then such Collaboration Antigen shall be designated a Discontinued Antigen and Exhibit B shall be amended accordingly.
During the period from the Restatement Effective Date until [***]following the FIN-525 First Phase II Completion, other than as part of any Development Programs under this Agreement, ▇▇▇▇▇ shall not, without the prior written consent of Takeda, directly or indirectly (through an Affiliate or a Third Party): [***].
During the period from the Original Effective Date until [***] following the FIN-524 First Phase II Completion, other than as part of any Development Programs under this Agreement, ▇▇▇▇▇ shall not, without the prior written consent of Takeda, directly or indirectly (through an Affiliate or a Third Party): [***].
The Borrower will establish no later than the Loan I Closing Date a separate Debt Service Reserve Account, maintained with the Lender's New York Branch, funded in Dollars with respect to each of Loan I and Loan II, on the earlier of (x) the date of the Phase I Completion Certificate or the Phase II Completion Certificate or (y) the last day of the Loan I Availability Period or Loan II Availability Period, as the case may be.
After the first Phase II Completion for a Candidate Drug that binds to and is directed against a Collaboration Antigen (other than a Discontinued Antigen or Failed Antigen), or earlier, at the election of AZ, AZ shall determine whether it wishes to proceed with the further development and commercialization of any Candidate Drug(s) that bind to and are directed against such Collaboration Antigen as a Licensed Product(s) by providing written notice to ABX (an “Election Notice”).