This is something I've run into several times now. A lot of biological samples are shared for research with a caveat in the MTA that they are "not for commercial use". What exactly does this cover? The specific example I'd like to know about is where DNA samples are used to validate a diagnostic test that might eventually be developed for commercial use. When does this become commercial? If I use materials for something that I don't expect to be commercial but I later want to develop it commercially, what happens?

I've asked the people sharing the materials but generally this results in "I don't know, better play it safe", partly because in many cases multiple partners and historical MTAs are involved and no one person wants to take responsibility for a decision. I'm looking for pointers to a clear set of criteria ("good subjective" - from personal experience of what works), ideally with an explanation of the wider legal context and any key legislation or decisions.

I'm in the UK but the samples are coming from (and going back out to) partners in South America (Brazil) and Europe (Greece, Italy, France).

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