fonda approval due july-oct-says rbs, page-10

Hey Tewk, I'll do my best from what I understand after chats over the time.

Firstly you had asked about how long EU approval may take a while back, from my understanding it can be anywhere from 12 - 24 months, after that approval they need to pass national phase which involves pricing and any country specific requirement within Europe. National approvals can vary from 2 - 9 months extra but Reddy's strategy will play a roll in timings, they are well versed at this. Data exclusivity for Fonda expires 21st March 2012 for Europe.

As for the profit share in Europe and ROW the agreement, from my understanding, is more about a ratio which is then converted to a royalty as the variables can be so different in each country, depending on pricing in each individual country and their requirements as per what I said above. The COGS at the time and the nature of the commercial arrangement in that specific country e.g. SG&A is lower if Reddy?s is selling it as a straight generic into a pre-existing market and higher if it is promoting it in order to create a market.

So yes the % earned will be lower compared to the US agreement with Reddy's but I can't see how RBS can come to any exact number, the variables will be determined once each and every country in Europe and the ROW are agreed upon.

Just my interpretation, please clarify for yourself:)