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

• 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.

• 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.

• Clinical trial insurance obtained by GW Pharma for the conduct of clinical trials under the First Indication Development Plan shall include Otsuka as an additional named insured.

• We will do whatever is within our talents and capacity to protect the right of each child to have the freedom and opportunity to develop his full potential.

• 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.

More Definitions of First Indication

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 7.2.

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

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

First Indication means Sickle Cell Disease.

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

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.