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Message: Re: Hepalink
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Feb 21, 2020 03:48PM

"Is this not sufficient enough for HL to manufacture RVX208 as they see fit for China? They would need to pursue on their own FDA China equivalent. (NMPA)"

I'm not familiar with drug approvals in China. But maybe what you're getting at is that apabetalone may be approved for use in China prior to other countries. There is a bit of ambiguity in the licensing agreement as I read it. To me, it sounds like Hepalink must purchase it from Resverlogix for use in China and the Territories. But I may be mis-interpreting it.

"Under the agreement between Resverlogix and Hepalink, Hepalink's price shall be the manufacturing cost plus 10%. Resverlogix also granted Hepalink an option to manufacture and supply products comprising RVX-208 outside the Territories. Resverlogix's price will be the manufacturing cost plus 10%. Resverlogix has the right to select a qualified third party to manufacture RVX-208 outside the Territories if Hepalink fails to meet the industry standards required."

BDAZ

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