Core Indications definition

Core Indications means those Indications for which the Parties wish to jointly develop the Product as part of their Core Development activities hereunder, which Indications are identified as Core Indications in the Initial Development Plan and Budget, together with such additional Indications as may be identified as Core Indications in the Core Development Plan as updated and modified from time to time in accordance with this Agreement.
View Source
Core Indications means (i) the use and application of clinical development programs of Vibegron for over-active bladder and over-active bladder in men with benign prostatic hyperplasia indications, and (ii) after the approval of the New Drug Application for Vibegron, the commercialization of Vibegron to the urologist physician market segment for such indications.
View Source
Core Indications means ABSSSI and Pneumonia.
View Source

Examples of Core Indications in a sentence

  • Milestone Payments to FibroGen for Approval Success: Astellas shall pay FibroGen $[ * ] US dollars upon granting of each of the first three Marketing Approvals in the Core Indications (except for [ * ]) in the EU (for a total aggregate amount of $[ * ] US dollars).

  • The Parties have agreed on the initial Development plan for the Licensed Product in the Core Indications in the Field in the Territory (as may be amended in accordance with this Agreement, the “Core Development Plan”), a copy of which is attached hereto as Exhibit A.

  • Bayer shall use Commercially Reasonable Efforts to develop, register and commercialize Product for the Core Indications in […***…] the Bayer Territory […***…].

  • Trius shall be the sponsor of the Global Trials in the Core Indications, and shall be responsible for conducting or having conducted, and shall use Commercially Reasonable Efforts to conduct, or have conducted, each Global Trial in accordance with the Global Development Plan.

  • Without limiting anything in this Section 5.1, it is the intention of the Parties to seek Regulatory Approval for the Core Indications and to use Commercially Reasonable Efforts to engage in the Regulatory Activities in support of obtaining such Regulatory Approvals, in the Territory.

  • Notwithstanding the foregoing, if Bayer does not receive a CPP from the FDA or the EMA, Trius shall prepare, file, obtain, maintain and be the holder of the Regulatory Approval for Product in the Field in China and those other countries of the Bayer Territory which require CPP ownership for obtaining Regulatory Approval for each of the Core Indications.

  • The parties acknowledge and agree that, unless otherwise mutually agreed by the parties in writing, the scope of the Global Development Plan is limited to development and registration of […***…] Product in the Core Indications […***…].


More Definitions of Core Indications

Core Indications means the indications of ISR, SV and BtK.
View Source
Core Indications means each of the following Indications: (i) ALPS, (ii) ADPKD, [***].
View Source