CEA Licensed Product definition

CEA Licensed Product means a Licensed Product which is to be administered by any method in any form including without limitation injection and intravenously, the sole active pharmaceutical ingredient of which is acetaminophen (as it may have been or may be modified by Licensor or Seelos for use in a CEA Licensed Product), and in which such sole active pharmaceutical ingredient is prepared, formulated or combined with Captisol.
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Examples of CEA Licensed Product in a sentence

  • Seelos shall have the right to reference the DMF solely in connection with Seelos’ regulatory filings (including Applications) submitted in connection with obtaining Regulatory Approval for a CEA Licensed Product.

  • At least 90 days before anticipated dosing of the first patient in a pivotal clinical trial of a CEA Licensed Product, the parties shall negotiate in good faith and enter into a Safety Data Exchange Agreement in a mutually agreed format in order for Seelos to monitor the safety of the CEA Licensed Products and to meet reporting requirements with any applicable regulatory authority.

  • Subject to Article VIII, CyDex shall have the right to reference and utilize all toxicology/safety and other relevant scientific data developed on Captisol alone (and not in conjunction with a CEA Licensed Product) by Seelos, its Sublicensees or Affiliates.

  • Seelos shall also advise CyDex regarding any proposed labeling, Application supplements or registration dossier changes affecting Captisol arising from CEA Licensed Product Adverse Event reports.

Related to CEA Licensed Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed producer means an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.