"Hepalink will be responsible for all clinical and development costs in the Territories, including a patient population that is expected to be included in the Company’s Phase 3 BETonMACE trial." - from MD&A

I can't find it but it seems to me that it was once stated that this included the regulatory process. I think it was touted that HL could navigate that process better.

On June 22,2015, RVX announced first confirmation for BoM Ph III trial Clinical Plan from European regulators. I believe they were ahead of the FDA with European regulators.