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).
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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.
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Named Indications means: [***].
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Examples of Named Indications in a sentence

  • 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.

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

  • The Parties shall, in accordance with the Development Plan set forth on Schedule 1.36, including the timing and budget set forth therein, and this Agreement, use Commercially Reasonable Efforts to Develop Named Compounds into Licensed Products for the Named Indications.

  • 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.

  • Only those Clovis Trials listed on Schedule A, as it may be amended from time to time, including the expansion of the Named Indications or the Clovis Target Alterations, shall be considered Clovis Trials for purposes of this Agreement.

  • 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.

  • Upon such determination by the JSC, the JSC shall remove such Named Compound or the relevant Named Indication(s) from Schedule 1.65 or 1.66, as applicable, pursuant to Section 4.1.2(e) at its next scheduled meeting (which in any event shall be no longer than three (3) months) unless there is a Development Plan or Commercialization Plan for any Licensed Product with respect to such Named Compound or such Named Indication in effect at such time of determination or 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.


More Definitions of Named Indications

Named Indications means, individually and collectively, MF, MDS and AML.
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Related to Named Indications

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Second Indication means [***].

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Additional Indication means any indication other than the Initial Indication.

  • 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.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

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

  • WTO GPA country end product means an article that—

  • Licensed Field means [***].

  • Licensed Compound means [***].

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).