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.
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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 [**].
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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”).

Related to Target Label

  • TARGET 2 means the Trans-European Automated Real-time Gross Settlement Express Transfer payment system which utilises a single shared platform and which was launched on 19 November 2007.

  • Target means Trans-European Automated Real-time Gross Settlement Express Transfer payment system.

  • KPI Target means the acceptable performance level for a KPI as set out in relation to each KPI;

  • Product Labeling means, with respect to a particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country.

  • Ballot label means the cards, papers, booklet, pages, or other materials that: