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

• 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.

• AstraZeneca hereby appoints and grants Prometheus, with effect from the First Sales Booking Date and during the remainder of the Term, the exclusive right to Promote the Product for the Approved Indication in the Territory under the Trademarks, and Prometheus hereby accepts such appointment and grant, subject to and in accordance with the terms and conditions of this Article 2 and the other terms and conditions of this Agreement.

• For example, for the second Approved Indication of a Licensed Product, payment for milestone 3 is $[***], and for the third Approved Indication of such Licensed Product, payment for milestone 3 is $[***].

• Subject to the terms and conditions of this Agreement (including as set forth in this Article 3), Merck hereby grants to Buyer at the Closing a fully paid-up, royalty-free, exclusive, and sublicenseable (in accordance with Section 3.4) license under the Licensed Trademarks to make, have made, use, offer for sale, sell and import the Products in the Territory for prescription use by humans for the Approved Indication for such Product for commercialization in the Territory.

• Subject to the terms and conditions of this Agreement (including as set forth in this Article 3), Merck hereby grants to Buyer at the Closing a perpetual, irrevocable, fully paid-up, royalty-free, non-exclusive, and sublicenseable (in accordance with Section 3.4) license under the Licensed Patent to make, have made, use, offer for sale, sell and import the Products in the Territory for prescription use by humans for the Approved Indication for such Product for commercialization in the Territory.

More Definitions of Approved Indication

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

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 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 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).