PoC Data Package means, with respect to the GSK-5 Program Development Candidate, (i) [***], (ii) [***], (iii) [***], (iv) [***], (v) copies of all filings submitted to Regulatory Authorities, (vi) [***], and (vii) [***]. In the event that GSK elects to exercise its early Option to the GSK-5 Program in accordance with the Agreement (as amended by this Amendment No. 4), the PoC Data Package will be interpreted to mean the items set forth in this Section 13.r (i) through (vii) to the extent such items are available at the time that GSK notifies Isis of GSK's election to exercise such early Option. s.
Examples of PoC Data Package in a sentence
Isis will promptly, and in any event within 15 days of receipt of the Deficiency Notice, resubmit a complete PoC Trial Completion Notice to Biogen Idec or its designated Affiliate, including any information required to be included in the PoC Data Package that Biogen Idec identified in the Deficiency Notice.
On a Collaboration Program-by-Collaboration Program basis, on or before 5:00 p.m. (Eastern time) on the [***] ([***]) day (each, an Option Deadline) following GSKs receipt of (i) written notice from Isis regarding the completion of the first Phase 2 PoC Trial for the applicable Development Candidate, and (ii) the applicable Phase 2 PoC Data Package (such notice and package, a PoC Trial Completion Notice), GSK will have the exclusive option to obtain from Isis the license set forth in Section 4.1.1 below.
Isis will provide to Biogen Idec or its designated Affiliate (i) written notice from Isis regarding the completion of a PoC Trial for ISIS 396443, and (ii) the PoC Data Package, to the extent not already provided to Biogen Idec under Section 3.1.1 above (such notice and package, a PoC Trial Completion Notice) promptly, and in any event within 30 days after database lock for the PoC Trial.
Following GSKs receipt of the PoC Trial Completion Notice (including the Phase 2 PoC Data Package as defined in this Amendment) for the TTR Program, GSK will provide written notice to Isis of its decision whether or not to exercise its Option to the TTR Program under Section 3.1 of the Agreement as soon as possible, but in any case, on or before 5:00 p.m. (Eastern time) on the [***] ([***]) day following GSKs receipt of the PoC Trial Completion Notice (the Option Deadline).
In such event, Isis will promptly provide GSK the Phase 2 PoC Data Package, to the extent available, for the applicable Collaboration Program.