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.

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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 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.

Examples of Approved Indications in a sentence

Product used in clinical trials in the Approved Indications or indications for which Regulatory Approval has been sought by the Licensor and its permitted licensees for non-commercial, internal research purposes (and with respect to UHN, academic or educational purposes), including in scientific cooperation with non-commercial third parties, will be provided by POINT (or as appropriate, its Sublicensee(s) or Affiliate(s)).
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.
Product used in clinical trials outside of the Approved Indications or indications for which Regulatory Approval has been sought can be manufactured by the Licensor or acquired through POINT.
The reports under sections 10.1 and 10.2 shall also include details of the number of patients treated, number of treatments per patient, the Approved Indications for which treatment was provided and details of referring doctors and the consideration received by Meizler for such treatments.
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.

More Definitions of Approved Indications

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, with respect to a Product, the indications for which such Product has been approved for marketing in the Territory as of the Closing Date by the applicable Healthcare Regulatory Authority as set forth in the Health Registration for such Product as of the Closing Date.

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

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 shall have the meaning set forth in Section 5.20 hereof.

Approved Indications has the meaning assigned to such term in Section 3.1.

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