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Monday, April 23, 2018 11:13:42 AM
Company A, the license holder is responsible for development up to and including filing marketing application with FDA.
Company B, the licensee will be responsible for the commercialization of the drug. Company B agrees to pay company A certain $$$ as upfront payment and additional $$$ per milestone (typically successful P3 trial(s) and successful marketing application) plus possible expert support with dealing with FDA.,
There is a simple reason for this deal structure: time. Company A usually has some sort clinical trial team (contract or not) possibly including kilo scale manufacturing in place, while company B would have to build one. Even the BIGGEST PHARMA does not have idle clinical trial staff lounging around office corners.
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