Secondary Indication definition

Secondary Indication means a use of a Licensed Product for an indication that is not the first indication for which such Licensed Product is seeking or has received Regulatory Approval, but is another indication intended to be the subject of an application submitted to a Regulatory Authority that includes clinical trial data from a Clinical Study seeking Regulatory Approval to market the Licensed Product for such use.
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Secondary Indication means [ * ].
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Secondary Indication means [**], as more particularly defined in the Development Plan.
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Examples of Secondary Indication in a sentence

  • Each Genzyme Territory Development Plan shall set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Studies for the applicable Split Territory Licensed Product from the Option Exercise Date until the later of (a) [***] from date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Licensed Product.

  • If a Party desires to conduct a Secondary Indication Study of a Split Territory Licensed Product for the purpose of seeking Regulatory Approval to market such Split Territory Licensed Product for a Secondary Indication, such Party (the “Proposing Party”) shall submit to the PSC responsible for such Split Territory Licensed Product a proposal to add such Secondary Indication Study to the applicable Split Territory Global Development Plan (an “Additional Development Proposal”).

  • Each Voyager Territory Development Plan shall subsequently be updated by Voyager from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed Product.

  • The Parties shall establish a Joint Management Committee (the "JMC") to oversee the development and commercialization program for Licensed Product for the Primary Indication and the Secondary Indication, and to facilitate the exchange of information between the Parties.

  • Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Licensed Product by or on behalf of Voyager with respect to the Voyager Territory, including Secondary Indication Studies, shall be set forth in a written work plan and time table (each, a “Voyager Territory Development Plan”).


More Definitions of Secondary Indication

Secondary Indication. : means any oncology indication other than a Primary Indication.
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Secondary Indication means any oncology indication other than a Primary Indication.
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Secondary Indication means the treatment, prevention or diagnosis of any indication that is not a Primary Indication.
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Secondary Indication means any use of the Compounds or Products in the Field for viral treatments in humans other than the first Indication.
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Secondary Indication means, with respect to a Licensed Product and a regulatory jurisdiction, any Indication that (a) is not the first Indication for which such Licensed Product has received Marketing Approval (and, if applicable, Price Approval) in such regulatory jurisdiction and (b) is not an Ultra-Rare Indication in such jurisdiction.
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Secondary Indication means [**], as more particularly defined in the Development Plan. ​
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Secondary Indication has the meaning set out in Section 6.4.1.
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