Product Indication definition

Product Indication means the clinical utility, intended use or clinical information of a particular Molecular Diagnostic Product, including, for example, the Product Indications identified in Appendices 1.5 and 1.10.
Sample 1
Product Indication means, on a country-by-country basis, any indication for which the Product has Marketing Approval in such country.
Sample 1

Examples of Product Indication in a sentence

  • The obligations of CTI with respect to any Product Indication or formulation under this Article 5 are expressly conditioned upon the continuing absence of any adverse condition or event relating to the safety or efficacy of such Product Indication or formulation, and the obligation of CTI to develop or market such Product Indication or formulation shall be delayed or suspended so long as such condition or event exists.

  • Licensee will promptly notify Mirati of the occurrence of Generic Competition, which notice will specify the apply Generic Product, Indication, and Region in the Licensed Territory.

  • Within ten business days of receipt of such notice, ARScience Bio will provide written notice to Coya confirming whether or not rights to such Coya Additional Mono Product Indication have been granted to a Third Party pursuant to Section 2.7.1 (Third Party Interest).

  • Thereafter, Cxxx will have an exclusive right exercisable no later than 60 days after receipt of such written notice to notify ARScience Bio in writing of its desire to conduct Pre-Clinical Proof of Concept Activities for the Mono Product in the Third Party Additional Mono Product Indication (a “ROFR Exercise Notice”).

  • Thereafter, Coya will have an exclusive right exercisable no later than 60 days after receipt of such written notice to notify ARScience Bio in writing of its desire to conduct Pre-Clinical Proof of Concept Activities for the Mono Product in the Third Party Additional Mono Product Indication (a “ROFR Exercise Notice”).

  • Any such proposal will be by written notice to the other Party and will identify the Proposed Celera Product, the Platform Technology of the Agreement Instrument on which such Proposed Celera Product is run, the Product Indication addressed thereby, and the proposed launch date.

  • Secretary at Transocean Project Pipeline 4 * Dates of key milestones are indicative and subject to change Product Indication Preclin .

  • If a Party or its Affiliates, directly or through a Third Party, Commercializes a Product or Molecular Diagnostic Product in the Decentralized Market for the same Product Indication as any Product, such Party will pay to the other Party a royalty on the Net Sales of such Molecular Diagnostic Product sold or otherwise distributed by or for such Party or its Affiliates at the rates and for the periods specified in Appendix 2.4.

  • Protocol VB-201-064 VB-201 Attachment No. 3 Study Protocol CLINICAL PROTOCOL Title: A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis Protocol No. VB-201-064 Eudra CT No.: 0000-000000-00 Investigational VB-201 Product: Indication: Ulcerative Colitis Development Phase: 2 Sponsor: Vascular Biogenics Ltd.

  • Selected Pipeline Products and New Indications Product Indication Third Party/Licensor Phase Date of Last U.S. Patent(1) Expiry (1) Patents referenced are orange-book listable.

Related to Product Indication

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

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

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

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

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

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Licensed Compound means [***].

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

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

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

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

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

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

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

  • Competing Product means [***].

  • 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.