Approved Indications definition

Approved Indications means any indications in any jurisdiction in the Field for which CPP has made a submission seeking Regulatory Approval for the Products.

Approved Indications means the following clinical indications for Licensed Products: (a) short-term treatment of duodenal ulcer (4-8 weeks), (b) short-term treatment of active benign gastric ulcer (4-8 weeks), (c) treatment of heartburn and other symptoms associated with gastroesophageal reflux disorder, or GERD, (d) short-term treatment of erosive esophagitis diagnosed by endoscopy (4-8 weeks), (e) maintenance of healing of erosive esophagitis and (f) reduction of risk of upper gastrointestinal bleeding in critically ill patients.

Approved Indications means the Initial Indication plus any Additional Indication, individually and collectively as the case may be.

Examples of Approved Indications in a sentence

• Daiichi Sankyo may, at no additional cost and without making any additional payments to Nektar, use any and all Safety-Related Information of Nektar in submissions for Health Registration Approval and in other Regulatory Documentation and in filings with Health Authorities, in each case in connection with the Licensed Product for the Approved Indications.

• Merck represents and warrants to Buyer that the Transferred Assets and Liabilities (as defined in the Transfer Agreement) exclude any and all assets, properties, rights and interests in the possession of Inspire reasonably necessary for the distribution, use, sale, offer for sale and marketing of the Products for the Approved Indications in the Territory as of the Closing Date.

• The ANDA approves Rosuvastatin Calcium Tablets for use for the FDA Approved Indications, if manufactured in accordance with the formulation and processes specified in the ANDA.

• Meizler shall only be permitted to market, promote and advertise the Deep TMS Devices within the Territory and for the treatment of the Approved Indication(s), and solely in accordance with the terms of the Protocol for treatment prepared by Brainsway and supplied to Meizler.

• Notwithstanding anything herein to the contrary, the licenses granted in this Section 2.1.1 shall be limited to (i) formulations of Licensed Products which are capsules, powder for oral suspension or chewable tablets for Approved Indications and (ii) other formulations or indications for which GSK develops a Licensed Product or for which GSK exercises its option pursuant to Section 8.1.2.

More Definitions of Approved Indications

Approved Indications means the Primary Indication and the Other Indications, in each case at such time as Regulatory Approval for such indication has been obtained.

Approved Indications means those indications for which Final Product has received Approval in Japan.

Approved Indications shall have the meaning set forth in Section 5.20 hereof.

Approved Indications means the precise and written descriptions for use as defined by the Registrations, the Market Authorizations and as may otherwise be defined by the Registration Authorities in the Countries within the Viragen International, Inc. & Orphan Australia Pty. Ltd. License Agreement 1

Approved Indications means any Indication for which a Product has received Regulatory Approval (whether in the United States or in any other country in the Territory).

Approved Indications means the precise and written descriptions for use as defined by the Registrations, the Market Authorizations and as may otherwise be defined by the Registration Authorities in the Countries within the Territory. Approved Indication(s) shall be specified in Exhibits to this Agreement, as samples of approved Product labeling, translated into English for convenience.

Approved Indications shall be those indications that are approved by the Swedish regulatory authorities as of the Effective Date of this Agreement, and those that may be approved through the Mutual Recognition Process in other countries within the EU, upon the initial application for approval.