Second Indication definition

Second Indication means [***].

Second Indication means the treatment of an indication other than Head and Neck cancer, and includes all subsequent indications after the First Indication.

Second Indication means an Indication listed under the header “INDICATIONS AND USAGE” of a Product’s approved label upon Regulatory Approval for the Product by a Regulatory Authority other than the AD Indication. For purposes of the milestones that occur prior to receipt of Regulatory Approval, “Second Indication” means an Indication that is not the AD Indication and is intended to be included in the regulatory filing for such Product.

Examples of Second Indication in a sentence

• The balance of such payment shall be paid by ALGORX to BRIDGE upon the first Regulatory Approval for such Licensed Product for the Second Indication in the first Preferred Country.

• Pursuant to and subject to the terms of this Agreement, with respect to the Shared Territory, the Parties agree to collaborate with respect to the Development of the Collaboration Product containing the Lead Compound for the Initial Indication as well as possibly for the Second Indication and/or Other Indications as provided in this Agreement, with the goal of obtaining Regulatory Approval for one or more Collaboration Products, in one or more indications in the Field, as soon as reasonably practicable.

• The Second Indication Opt-In shall be effective as of the date of such notice.

• 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.

• 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.

More Definitions of Second Indication

Second Indication means the second Indication for which NDA Approval for the Product is obtained.

Second Indication means a new indication (i.e., a generally recognized distinct medical condition) and not an extension of the First Indication or a labeling change covering the First Indication.

Second Indication means any disease or condition listed under the header “INDICATIONS AND USAGE” of a Product’s approved label upon Regulatory Approval for the Product by a Regulatory Authority other than the First Indication.

Second Indication means any indication other than the First Indication.

Second Indication means label claim(s) that are approved in a Regulatory Approval received for a Product in the Territory, wherein such Regulatory Approval is subsequent to the Initial Approval and such label claims are for a different indication than the indication approved in the Initial Approval.

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

Second Indication in the table above refers to second Indication of the Licensed Product. The Parties expect that the second indication would be [***] but acknowledge that the First Indication could be any other Indication. For greater clarity, the term “first indication” / “second indication” / “third indication” used in each milestone above shall not be restricted to be the same indication, and the order of “first”, “second” and “third” shall be counted on a milestone by milestone basis. Additionally, a label expansion that adds additional clinical data showing overall survival will not constitute a second or third indication.