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

• 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”).

• 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”).

• 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.

• ALVOTECH shall keep STADA informed as to its progress in obtaining such Additional Indication Freedom to Launch.

• 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).

More Definitions of Additional Indication

Additional Indication means any Indication for a Product outside of the Field.

Additional Indication means, with respect to the Licensed Compounds and Licensed Products, each indication other than the Initial Indications.

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 means any disease condition, [*****].

Additional Indication means, with respect to any Licensed Product, each Licensed Indication other than the Initial Indication with respect to such Licensed Product.

Additional Indication means any indication other than the First Indication and the Second Indication, if any, as determined in the sole discretion of Otsuka.

Additional Indication means any indication for Licensed Products other than r/r MDS, Frontline MDS, Frontline Pancreatic or Ovarian Cancer.