|Eligibility for sublicences
||Sublicences can be issued to any qualified entity worldwide.
||Allows manufacturing of the active pharmaceutical ingredient and the finished formulation of LPV/r and RTV anywhere in the world.
|Geographical scope for sale
||Allows for sale of LPV/r and RTV in all African countries.
|Sales outside the licensed territory
|Sales outside Africa are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
||The licence is royalty free.
||Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained.
||Sublicensees have the right to combine LPV/r or RTV with other ARVs and to develop suitable new fixed-dose combinations.
||Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics.
||The licence discloses the list of pending and granted patents on LPV/r and RTV worldwide.
|Additional flexibilities for licensees
||Licensees have the right to challenge the validity of any of the licensed patents.
See related licence
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