Additional Indication definition

Additional Indication means any indication other than the Initial Indication.
Additional Indication has the meaning set forth in Section 3.9(a).
Additional Indication means, with respect to a particular Licensed Product, an indication for treating or preventing a human disease or condition that is the subject of and covered by a unique NDA application and Regulatory Approval, different from and subsequent to the original Regulatory Approval for such Licensed Product.

Examples of Additional Indication in a sentence

  • The period during which Auxilium may exercise an Additional Indication Option (the “Exercise Period”) shall commence on the date on which BTC submits a Phase II Clinical Trial report to Auxilium for the Product for such Additional Indication and ends one hundred and twenty (120) days thereafter.

  • Auxilium may exercise the Additional Indication Option at any time during the Exercise Period by delivering to BTC a written notice of exercise with regard to such Additional Indication (each, an “Exercised Indication”) that sets forth the effective date of the exercise (the “Exercised Indication Date”).

  • Subject to the terms and conditions of this Agreement, BTC hereby grants to Auxilium an exclusive option to an exclusive license to Products in the Territory for each Additional Indication on the same terms and conditions as provided for Indications in the Field (each, an “Additional Indication Option”).

  • The Nominated Counsel, acting reasonably, shall advise ALVOTECH if he/she approves or does not approve the draft settlement as satisfactory for the purposes of ALVOTECH confirming Freedom to Launch or Additional Indication Freedom to Launch (as applicable) under this Agreement and shall clearly advise in its response as to whether the settlement agreement provides for Freedom to Launch or Additional Indication Freedom to Launch (as applicable).

  • The appointed Patent Counsel shall then determine if STADA has provided reasonable arguments in declaring its dissatisfaction as to whether there is Freedom to Launch or Additional Indication Freedom to Launch (as applicable) or not under the settlement agreement, along with a final determination as to whether the settlement agreement provides for Freedom to Launch or Additional Indication Freedom to Launch (as applicable).


More Definitions of Additional Indication

Additional Indication means, with respect to the Licensed Compounds and Licensed Products, each Indication other than the Lead Indication.
Additional Indication means any Indication for a Product outside of the Field.
Additional Indication means any disease condition, [*****].
Additional Indication means any disease within the Licensed Field other than the Initial Indication.
Additional Indication means each specific cancer indication (other than […***…]) which Bellicum elects to include in the Licensed Field pursuant to the provisions of Section 2.1.2(a).
Additional Indication has the meaning set forth in Section 2.3.2.
Additional Indication means a human disease or pathological condition intended to be treatable by a therapeutic product other than the Initial Indication.