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Re: beachhyena post# 452070

Thursday, 03/17/2022 6:35:28 AM

Thursday, March 17, 2022 6:35:28 AM

Post# of 698579
Again, here is the language, and exwannabe is right, we’ve only heard about the first 25% milestone being met. It seems like they should have met the second by now? I will note, reading this again after a long break from seeing it, it does seem obvious EDEN is only for commercial manufacturing. Again, it seems this is the bottleneck (as opposed to a Journal article). Imo.

2.
Vesting; Settlement; Termination.
(a)Subject to the other conditions set forth in this Agreement, the Rights shall become vested as follows:
(i)Twenty-five percent (25%) of the Rights shall vest upon completion of all of the following:
(A)delivery to the Company by Recipient of a document listing all technical and regulatory requirements for the deployment of the EDEN system to manufacture DCVax-L, together with a detailed timeline;
(B)the initiation of EDEN system consumable sourcing from Saint Gobain or an equivalent supplier, via issued purchase order;
(C)the technology transfer of all relevant Company manufacturing protocols for DCVax-L to Flaskworks’ Boston site;
(D)
readiness of the EDEN prototype for testing at Advent
Bioservices; and
(This was met around May 2021)

(ii)Twenty-five percent (25%) of the Rights shall vest upon the demonstration to the Company’s reasonable satisfaction that the EDEN system can replicate the Company’s current DCVax-L manufacturing process as verified by yield, phenotype and functional assay data. (Has this been met?)
(iii)Twenty-five percent (25%) of the Rights shall vest upon the completion to the Company’s reasonable satisfaction of comparability studies that demonstrate equivalence between EDEN and the Company’s current process for DCVax-L, and equivalence of the DCVax-L products manufactured through EDEN and those manufactured through the Company’s current process. For purposes of this Agreement, “Completion” shall mean that all applicable data is available and prepared in a consolidated format sufficient for submission to regulatory agencies in the UK, US, Canada and EU. (Has this been met?)
(iv)Twenty-five percent (25%) of the Rights shall vest upon approval by the regulator in the US or EU of the comparability of the EDEN process and the Company’s current processes, and the comparability of DCVax-L products manufactured through EDEN and those manufactured through the Company’s current processes, for commercial use. (Has this been applied for?)

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