Target Label definition
Target Label means the Indication for which the Parties intend that the Marketing Authorization will be granted, and the correlative estimated patient population which the Parties expect may be treated by such Indication (the “EU Target Population”), with respect to the Initial Product in the member states of the European Union, Norway, Iceland and Liechtenstein as further described in Schedule 4.
Target Label means approved labeling for the Product with: (i) an indication for the treatment of insomnia; (ii) [**] which would [**], and (iii) [**] attached at Schedule 1.50. For the avoidance of doubt, the label requirements at Section 1.50(ii), above, shall not apply to [**].
Examples of Target Label in a sentence
If, after [**], the Company RA Executives are unable to agree about whether the Target Label has been met, they shall agree upon one additional independent party, unaffiliated with either party, who is an acknowledged expert in product labeling within the EU (“Independent RA Expert”).