Named Indications definition

Named Indications means indications set forth on Schedule 1.53, as amended from time to time pursuant to the terms of this Agreement, including without limitation, any amendments necessary to include all indications involving the ThermoDox Products for which either Celsion (outside of the Territory) or Yakult (within the Territory) has received Marketing Authorization from the FDA or MHLW, respectively, or any other mutually agreed indication. As of the Effective Date, the Named Indication is Hepatocellular Carcinoma (“HCC”). As set forth in Sections 2.1 and 4.2, this Agreement requires Yakult to study and submit for approval all indications that have been approved by the FDA or other international Regulatory Authority (i.e. major market countries that participate in ICH such as UK, France, Germany and Canada).
Sample 1Sample 2
Named Indications means indications set forth on Schedule 1.66, as amended from time to time pursuant to the terms of this Agreement. As of the Effective Date the Named Indications shall be pain.
Sample 1
Named Indications means, individually and collectively, MF, MDS and AML.
Sample 1

Examples of Named Indications in a sentence

  • Upon such determination by the Committee, the Committee shall remove such Named Indication(s) from Schedule 1.53 unless otherwise agreed to by the Parties.

  • Sales targets will be adjusted for additional approved indications beyond the Named Indications.

  • A parenting facilitator who is also a licensed psychologist in Texas is a provider of forensic psychological services and must comply with all other applicable Board rules and state and federal laws relating to the underlying areas of psychology relating to those services.

  • Note that the host of the topmost level is the System Integrator (SI).

  • Upon such determination by the Committee, the Committee shall remove the relevant Named Indication(s) from Schedule 1.53, as applicable, unless otherwise agreed to by the Parties.

  • The Parties shall enter into one or more Research Program SRAs within [***] after the Effective Date to fund Licensor’s pre-clinical research and development activities for the [***] Named Indications.

  • Yakult shall, in accordance with the Development Plan set forth on Schedule 2.3.1 , including the timing and costs set forth therein, and this Agreement, use Commercially Reasonable Efforts to Develop ThermoDox Products for the Named Indications.

  • Patricia Irwin (Swarthmore College) explores the acceptability of motion sentences in English with whole-body roots like √DANCE versus body-part roots like √SMILE.

  • Also attached as appendix 2 are the minutes of Executive Board on 22nd January 2014.

  • Named Indications ” means indications set forth on Schedule 1.53 , as amended from time to time pursuant to the terms of this Agreement, including without limitation, any amendments necessary to include all indications involving the ThermoDox Products for which either Celsion (outside of the Territory) or Yakult (within the Territory) has received Marketing Authorization from the FDA or MHLW, respectively, or any other mutually agreed indication.


More Definitions of Named Indications

Named Indications means: [***].
Sample 1

Related to Named Indications

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.