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Re: longfellow95 post# 251265

Wednesday, 11/13/2019 9:45:11 AM

Wednesday, November 13, 2019 9:45:11 AM

Post# of 703844
Regarding this “manufacturing readiness, which they will need to demonstrate at a pre-BLA stage. “

What do you make of this nugget from the 10-Q?

On November 8, 2019, the Company and Advent entered into an Ancillary Services Agreement with an 8-month Term for the U.K. Facility Development Activities and the Compassionate Use Program Activities. The Ancillary Services Agreement establishes a structure under which Advent will develop Statements of Work (“SOWs”) for each portion of the U.K. Facility Development Activities and Compassionate Use Program Activities, and will deliver those SOWs to the Company for review and approval. After an SOW is approved by the Company, Advent will proceed with or continue the applicable services and will invoice the Company pursuant to the SOW. Since both the U.K. Facility Development and the Compassionate Use Program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement will be on the basis of costs incurred plus fifteen percent.
 


It says to me that manufacturing readiness is now at hand with Advent for the UK/EU, since the “Compassionate Use Program” has been supported and manufactured at King’s College London (with the assistance of Fraunhofer Institute in Germany). It seems unusual that the Service Agreement has an 8-month term though. What are they expecting in 8 months?
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