Acceptable Label definition
Acceptable Label means, for an applicable Product, a label for such Product as issued and approved by the applicable Regulatory Authority and acceptable to GSK in its sole discretion.
Acceptable Label means, for a Subject Product in the United States, FDA-approved labeling for the treatment of bacterial conjunctivitis, where such label: (a) indicates dosing of such Subject Product of not more than two (2) times daily for seven (7) days, (b) permits expiration dating of such Subject Product of no less than eighteen (18) months, and (c) has a comparable side effect profile to ocular antibiotics being marketed as of the Effective Date.
Acceptable Label means, for a specific indication (such as, for the first line treatment of non small cell lung cancer in women), that the Product has been granted Regulatory Approval in the appropriate jurisdiction for such specific indication by achieving its primary survival end point in the corresponding pivotal study(ies) and which primary survival end point for the Product was more favorable (with a difference which was statistically significant) than for the control arm in such pivotal study(ies).
More Definitions of Acceptable Label
Acceptable Label means a label for the Original Product satisfying the criteria set forth on Schedule 1.1.