Examples of Orphan Indication in a sentence
Orphan Indication: the proposed indication for the purpose of orphan designation.
So, for example, if a Product is only approved for an Orphan Indication and achieves Calendar Year Net Sales of [***] (and no other Product Directed To the same Project Target has achieved Calendar Year Net Sales of [***]) then the first Commercial Milestone Event will be deemed achieved by such Product.
However, if, prior to achieving the next Commercial Milestone Event, such Product is subsequently approved for an indication that is not an Orphan Indication then it will not be deemed to have achieved the next Commercial Milestone Event until it has Calendar Year Net Sales of at least [***].
If a Product is approved solely for an Orphan Indication (and no other indication) then the Net Sales thresholds in the Commercial Milestone portion of Table 8.2 will be deemed reduced by [***] percent ([***]%) for such Product for so long as the Product is solely approved for an Orphan Indication.
An Orphan Indication is conveyed by the U.S. Food and Drug Administration for products that treat rare diseases and thus have little potential to become huge commercial successes.