Anavex Life Sciences Corp (AVXL)

[sokol]

Business Partnership: Exclusivity (Patent protection or FDA exclusivity) is a key to consummating an agreement with a business partner. The degree of exclusivity is a major factor in determining value. Of course, if AVXL 2-73 obtains FDA approval, there is a limited exclusivity period regardless of whether Anavex manages to secure patent protection for the drug. Patent protection is governed by the Patent and Trademark Office and generally, runs 20 years from the date of filing (there may be some extensions of the 20 year period and some I mention below). FDA approval involves varying periods of exclusivity as follows:

Orphan Drug (ODE) - 7 years

New Chemical (NCE)- 5 years

"Other" Exclusivity - 3 years for a "change" if criteria are met

Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity

Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

Therefore, it is in the interest of both parties to an agreement to develop any drug to wait for more certainty on which period of exclusivity applies before completing a developmental arrangement. I believe in the science behind the drug, and we have had some interesting indications from the clinical trial. I believe that the parties are waiting to settle the exclusivity issue.