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 [***].

Examples of First Indication in a sentence

• Leave blank.(15b) First Indication of Trouble/How Recognized Code.

• If during the course to the First Indication Development Plan, either Party comes to believe that Development Costs for the First Indication are likely to exceed by ***% or more the estimated Development Costs, such Party shall notify the relevant JDC sub-committee at its next meeting, together with the reasons for the same.

• Pfizer shall notify GMI in writing promptly of any decision to cease development activities, efforts to obtain Regulatory Approval, or commercialization of the Licensed Product for the First Indication in the United States and the Major Countries of Europe.

• At any time prior to [***] months before the [***], either Party may propose to Develop in the Profit Share Territory Licensed Products for one or more additional indications in the Field (i.e., in addition to the First Indication) by submitting to the JDC a written proposal for the Development thereof, including a proposed work plan, budget and timeline.

• The Parties acknowledge and agree that it is their intent to seek Marketing Approval in the First Indication for a label that is as broad as reasonably possible (including, for clarity, broad use by age), taking into account, among other things, the requirements of Applicable Laws and the interest in making Licensed Products in the Field commercially available in a timely manner.

More Definitions of First Indication

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

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

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 5.2.1.

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.

First Indication means the initial indication among a Movement Disorder Indication, an Addiction Indication and an Other Indication that reaches the corresponding Milestone, and “Second Indication” shall mean an indication among such three indications, excluding the one from which the First Indication was drawn, that secondly reaches the corresponding Milestone, and “Third Indication” shall mean the last indication among such three indications, excluding the two from which the First Indication and Second Indication were drawn, that reaches the corresponding Milestone, e.g., if the initial indication to reach a Phase 1 clinical Milestone is a Movement Disorder Indication, such Movement Disorder Indication shall trigger the First Indication Phase 1 Clinical Milestone Fee, if the indication to secondly reach a Phase 1 clinical Milestone is an Addiction Indication, such Addiction Indication shall trigger the Second Indication Phase 1 Clinical Milestone Fee, and thereafter the Third Indication Phase 1 clinical Milestone Fee shall be triggered if and when an Other Indication reaching a Phase 1 clinical Milestone.