GTC Biotherapeutics (fka GTCB)

[DewDiligence]

When will Ovation pay milestones?

$9M of the $257M total potential milestones pertains to the HD indication:

• $3M already received on deal closing
• $1.5M on FDA acceptance of BLA for review
• $0.5M on granting of a priority review
• $1.0M on positive opinion from FDA advisory panel
• $3.0M* on FDA approval of BLA
[*Amount is $4.0M if no advisory panel was held or if FDA overrules a negative panel vote.]

The other $248M consists of undisclosed amounts triggered by three clinical/regulatory milestones for the DIC indication and undisclosed annual sales-based milestones on a nine-tier schedule that apply when sales in the preceding year exceed an undisclosed threshold. There are no clinical/regulatory milestones for the CABG/HR indication.

The three clinical/regulatory milestone triggers for the DIC indication are: i) establishment of a mutually agreeable clinical-development plan (including Leo if the development plan is global); ii) FDA acceptance for review of the sBLA; and iii) FDA approval of the sBLA.

http://sec.gov/Archives/edgar/data/904973/000119312508170051/dex101.htm

This post supersedes #msg-30253171, which is obsolete.