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HDGabor

06/12/20 5:42 PM

#279835 RE: jessellivermore #279791

JL-

Any idea what certain customary circumstance might be?

such customary circumstances include the following, each of which are subject to FDA approval of the Teva ANDA:

1. If another generic company obtains FDA approval and launches at risk to them pending the planned appeal of the March 2020 United States District Court for the District of Nevada ruling, only if Amarin does not obtain an injunction removing such product from the market within 60 days. In such case, Teva could also launch at risk to them but would be required to withdraw its product from the market if the other entities that launched at risk withdraw their products.

2. If Amarin loses its substantive appeal of the March 2020 district court decision (i.e., after issuance of the Federal Circuit mandate after any Federal Circuit rehearing or en banc review).

Best,
G