First Indication definition

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

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First Indication means [***].

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.

Examples of First Indication in a sentence

• 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.

• 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.

• 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.

• In the case of a tied vote, Otsuka’s vote shall control; provided, however, no action taken by virtue of Otsuka’s controlling vote shall obligate GW Pharma to incur expenses or assume liabilities in addition to those contemplated by this Agreement, the First Indication Development Plan and the Second Indication Development Plan or to derogate from GW Pharma’s right to manage and conduct the development activities under the First Indication 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.

More Definitions of First Indication

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

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

First Indication has the meaning set forth in Section 7.2.

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

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 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.