It doesn't need to be available everywhere - highway only is enough. For sub-regions, it must be available in either an entire country of the EU, or an entire state in the case of the US. i.e. availability in California before any EU country is a yes; available in Poland before any US state is an immediate no. In each region it must be approved by regulators.

If it comes out on the same day in both, it's a no.

If it never comes out, this resolves no. Deadline will be extended if necessary.