Indication definition

Indication means any disease or condition, or sign or symptom of a disease or condition.
Indication means [***].
Indication means a separate and distinct disease or medical condition in humans which a Product that is in Clinical Trials is intended to treat, prevent and/or diagnose and/or for which a Product has received Marketing Authorization.

Examples of Indication in a sentence

  • Following the License Commencement Date, (i) OST will be the responsible party for all Regulatory Filings for the Licensed Products in the Field, including Regulatory Approval of the BLA for the First Indication by the FDA and any other Regulatory Authorities, and (ii) OST shall own all Regulatory Filings related to the Licensed Products in the Field.


More Definitions of Indication

Indication means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition. For the avoidance of doubt, all variants of a single disease or condition (e.g., variants of colon cancer or variants of prostate cancer), whether classified by severity or otherwise, shall be treated as the same Indication for purposes of this Agreement.
Indication means a disease, disease stage, discrete form of a disease or any precursor condition thereof or a line of treatment thereof ***, for which a separate Regulatory Approval Application has been obtained or is being sought.
Indication means any human diseases, syndromes and medical conditions that can be diagnosed, treated, prevented or ameliorated.
Indication means any human disease or condition, or sign or symptom of a human disease or condition.
Indication means a separately defined, well-categorized class of human disease or condition for which a separate MAA (including any extensions or supplements) may be filed with a Regulatory Authority. For clarity, if an MAA is approved for a Product in a particular Indication and patient population, a label expansion for such Product to include such Indication in a different patient population shall not be considered a separate Indication. For further clarity, all subtypes of a particular tumor type and all treatments thereof, including all lines of treatment shall be deemed the same Indication.
Indication means any symptom, cause, or occurrence in a Sickness that points out the cause, diagnosis, course of treatment, or prognosis of the Sickness.
Indication means any separate and distinct disease (or stage of disease), disorder or medical condition in humans or non-human animals which a Product is intended to treat, prevent, diagnose, monitor or ameliorate and which, for a Product candidate, is intended to be reflected in the labeling for such Product as an approved indication, and which, for an approved Product, is reflected in the labeling for such Product.