I have just gotten out of a meeting talking about reasonable access to 'data that is reasonably required by the Health Authorities (HA).'

You see, when you have split your territory during out-licensing and expect 'good faith' reciprocal access to development data for carved-out territory, the concept is easier then the implementation, especially when the relationship is well, a little tense. With another partner, the same clause was just smooth as silk, they even defended the product at the HA, which was not their territory. Why? Because they wanted a good reputation everywhere and it is good for them if the product did well globally, even if the territory was not theirs. Quite enlighted thinking.

In this situation, we are debating - what type of data can we access?They all have different implications.

Raw data
Audited data
Conclusions from any data
Audited draft report
Final report
Final written study report form

Be warned- do not take 'data' for granted in your licenses!