Initial Label definition

Initial Label means human use in moderate to severe post operative pain in adults, for use within a hospital.
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Initial Label means a label for a Product which includes all the Initial Indications, unless otherwise agreed in writing by the Parties pursuant to a review by the Joint Patent Committee with respect to any issues relating to the Intellectual Property Rights of Third Parties.
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Examples of Initial Label in a sentence

  • The Parties shall reasonably cooperate to change the Label of Tuzistra XR so that such Product may be Launched as soon as reasonably practicable after the Effective Date (the “Tuzistra XR Initial Label Changes”).

  • Any changes or supplements to the Labeling for any Product following the transfer of the NDA for a Product to AYTU shall be at AYTU’s sole cost and expense; provided, however, that the costs and expenses of the Tuzistra XR Initial Label Changes, other than incurred with respect to filings and interactions with Regulatory Authorities, shall be at TRIS’ sole cost and expense.

  • In the event that AYTU wishes to modify or change the Label for a Product, other than such changes to the Label as of the Effective Date on Tuzistra XR to effectuate the Tuzistra XR Initial Label Changes, AYTU shall provide at least sixty (60) days’ advance notice of such desired change to TRIS and forward such modifications or changes to TRIS for incorporation into the Packaging and Labeling of such Products.

  • Alvogen shall (itself or, subject to ‎Section 3.3, through its Affiliates or Third Parties) use Diligent Efforts to file with the FDA and defend the NDA for Product and obtain NDA Approval for Product with the Initial Label Indication.

  • Subject to the preceding paragraph, Alvogen shall manage, conduct and pay for any additional non-clinical studies for the Initial Label Indication, including such studies mentioned above, which may be required by the FDA to obtain approval of the NDA, although NRx shall, at Alvogen’s request, advise Alvogen on the management of this study, such advice to be provided at NRx’s own expense.

  • You shall submit each of the following artists in the Initial Label Period (collectively, the "Initial Artists"): ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ p/k/a "Shiva Black" and ▇▇▇▇▇ ▇▇▇▇▇; it being the intention of the parties hereto that you cannot deliver the services of any of the Initial Artists to a third party.

  • Within ten (10) days of Alvogen’s receipt of a copy of the FDA’s notice of NDA Approval for Product with the Initial Label Indication, Alvogen shall pay to NRx a one-time payment in the amount of Five Million Dollars ($5,0000,000).

  • The term of this agreement (the "Term") shall be for an initial period ("Initial Label Period") commencing on the date hereof and ending twenty-four (24) months from the date hereof.

  • The Label Option Period shall commence upon the expiration of the Initial Label Period and shall end twenty-four (24) months thereafter.

  • ANTRA may exercise said option by sending you a notice at any time before the end of the Initial Label Period.