First Indication definition

First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

First Indication means [***].

First Indication means a first indication for which a Product receives approval.

Examples of First Indication in a sentence

• The choice of the First Indication will be stated in the Development Plan and will be the focus of initial clinical development activities thereunder to support regulatory approval of Compound Product in Japan.

• A draft of the protocol including endpoints, to the extent they can be projected to the satisfaction of the Parties prior to March 1, 2005, for the First Indication shall be set forth in the Development Plan.

• Without limiting Aucela’s rights to receive Milestone Payments pursuant to Section 6.2.1 for the First Indication, Otsuka shall pay to Acucela one-half (1/2) of the Milestone payments set forth in Section 6.2.1 above within sixty (60) days after the achievement of the corresponding development Milestone with respect to the Second Indication for which such development Milestones are achieved.

• Threshold expects to engage MediBIC or a third party to conduct all clinical trials for the First Indication.

• The anticipated timeline for clinical trials and regulatory submissions leading to approval of a Compound Product for the First Indication shall be set forth in the Development Plan.

More Definitions of First Indication

First Indication means the [***]

First Indication means any Indication for or related to the treatment of Fragile X syndrome (FXS), including but not limited to the treatment of signs and symptoms of FXS and/or the treatment of any subpopulation or subset of FXS patients.

First Indication has the meaning set forth in Section 1.1

First Indication means the treatment of Head and Neck (H&N) cancer in a human.

First Indication means any indication listed under the header “INDICATIONS AND USAGE” of a Product’s approved label upon Regulatory Approval for the Product by a Regulatory Authority, including any patient group, population or subpopulation, including but not limited to an indication for treatment in the Field.

First Indication means Sickle Cell Disease.

First Indication means the first Indication in which AstraZeneca obtains the first Health Registration Approval in respect of the Product or a Combination Product.