Question
From:
(redacted)
Sent:
Monday, August 25, 2008 10:46 AM
To:
Verne, B. Michael
Subject:
CONFIDENTIAL --HSR reportability regarding an IP license
Mike,
I would appreciateyour guidance on a question regarding HSR reportability with respect to acquisitionof an IP license relating to an active pharmaceutical ingredient("API"). The proposed license from patent holder A would grantexclusive right to company B manufacture the API and exclusive right to sellthe API in the US. Licensor A would retain rights to promote and also the rightto develop the API under the patent (which development right I understand tomean that licensor A is responsible for seeing the pharmaceutical productthrough FDA approval). Would retention by A of co-promotion rights anddevelopment rights in the US be sufficient to render the license non-exclusivefor HSR reporting purposes? Or does the question of license exclusivity reallycome down to whether there has been an exclusive grant of manufacturing rightswithin the territory?
Informal opinionsI have seen which discuss retention of rights by the licensor to co-promotealso appear to involve the licensor's retention of some manufacturing rights(which is not the case here, at least not within the US territory). See, e.g.,
http://www.ftc.gov/bc/hsr/informal/opinions/0601012.htm
http://www.ftc.gov/bc/hsr/informal/opinions/0709013.htm
Your prompt advicewould be greatly appreciated. Please feel free to call me at the number belowif it would make sense to discuss.
Many thanks,