Approved Indication definition

Approved Indication means, with respect to a Licensed Product, a specific human disease or condition for which the treatment or prevention has received Regulatory Approval.

Approved Indication means a tumor type indication (in the Cancer Field) or other indication (outside of the Cancer Field) for which a Licensed Product or Improvement has Approval in a given country of the Novacea Territory.

Approved Indication shall have the meaning provided in Section 5.2(d)(iv).

Examples of Approved Indication in a sentence

• CONFIDENTIAL TREATMENT REQUESTED determined and reconciled as if such Approved Licensed Product had only Achieved milestones within such Approval Pathway and for the Approved Indication (taking into account all other milestones that have been Achieved with respect to the applicable Arcus Program as of the date of such Marketing Approval).

• Provided that NOVACEA has received necessary supplies from XXXXXX XXXXX pursuant to the Supply Agreement, NOVACEA agrees to use Diligent Efforts to commercially launch the Licensed Product in each country of the NOVACEA Territory within ninety (90) days from the date of Approval of a first Approved Indication in each such country of the NOVACEA Territory.

• Provided that no additional Clinical Trials beyond those set forth in the Development Plan are required by the FDA or HC, NOVACEA agrees to use Diligent Efforts to file a NDA for a first Approved Indication of the Licensed Product as set forth in the Development Plan.

• For each Regulatory Approval of a Licensed Product, including with respect to each Approved Indication, Licensee will notify Inhibrx in writing within thirty (30) days thereof.

• If CPP abandons commercialization of Products for an Approved Indication within the Field or in any country within the Territory, then sanofi-aventis’ exclusivity obligation shall terminate on an indication-by-indication basis and a country-by-country basis, as applicable, and sanofi-aventis shall no longer be obligated to exclusively manufacture Products for CPP for development and use in such Approved Indication or in such country, as applicable.

More Definitions of Approved Indication

Approved Indication means the indication(s) for which the Product is approved by the FDA in the Territory.

Approved Indication means, with respect to a Licensed Product, a specific human disease or condition for which the treatment or prevention has received Regulatory Approval, where, for clarity, with respect to FDA Regulatory Approval, a specific human disease or condition receiving Regulatory Approval under an initial New Drug Application (NDA) or Biologics License Application (BLA) (both as defined in Title 21 of the U.S. Code of Federal Regulations or any successor law or regulations thereto, as amended from time to time) would be an Approved Indication, and each additional specific human disease or condition under a supplemental NDA or supplemental BLA for use would be a separate Approved Indication, but, for clarity, if a supplemental NDA or supplemental BLA or any amended or expanded label claim in an NDA or BLA covers any specific human disease or condition that was included in a previous Approved Indication, such supplemental NDA or supplemental BLA or amended or expanded label claim in an NDA or BLA shall not be deemed to be a separate Approved Indication. For the avoidance of doubt, the Parties acknowledge there may be more than one Approved Indication for any given histology or tumor type.

Approved Indication means the "management and relief of oral pain, by adhering to the mucosal surface of the mouth for soothing of lesions of various etiologies." The Approved Indication will be deemed amended or changed in scope in accordance with any additional regulatory approvals of the Product in the Territory.

Approved Indication has the meaning set forth in Section 12.5(a).

Approved Indication for the Product shall mean: (i) the approved use as set forth on the Product’s package insert; and (ii) any other indication approved by the FDA for the Product during the term of this Agreement.

Approved Indication means, with respect to an Existing Product, an indication for which such Existing Product has been approved by the FDA as of the Effective Date.

Approved Indication means chronic weight management in adult patients that are (i) obese or (ii) overweight with at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus or dyslipidemia, as determined by the patient’s body mass index (BMI).