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
The Seller shall use Commercially Reasonable Efforts to (i) complete clinical development of the Product in the Territory as required for U.S. Marketing Approval, (ii) obtain and maintain the U.S. Marketing Approval, and (iii) obtain and maintain Marketing Approvals for the Product for the Approved Indication in the Territory, and (iv) following Marketing Approval of any Product in the Territory, Commercialize such Product in the Territory.
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 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 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 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).
Approved Indication has the meaning set forth in Section 12.5(a).