Renal Indication definition

Renal Indication means the prevention, treatment, or amelioration of any renal disease or condition, including renal insufficiency, chronic kidney disease, acute kidney failure, ischemia-reperfusion injury of the kidney, glomerulonephritis, and all other forms of nephritis (whether acute or chronic).
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Renal Indication means a treatment directed to acute or chronic renal disorders and related disorders including, but not limited to, renal osteodystrophy and vascular calcification.
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Examples of Renal Indication in a sentence

  • Without limitation to Licensee’s rights under Section 5.4, Licensor shall have the non-exclusive right to co-promote in [***],[***],[***], and [***] the Licensed Product containing the first Licensed Compound for an indication other than the Renal Indication, solely for such indication.

  • Affymax shall prepare and author all Renal Indication documents and build, submit and maintain any Regulatory Materials for Regulatory Approval of the Product in the U.S., in accordance with the regulatory strategy approved as a component of the U.S. Development Plan by the JSC.

  • In order to exercise such co-promotion right, no later than three (3) months after Licensor receives a written notification from Licensee of the filing with the EMA of the MAA for the Licensed Product containing the first Licensed Compound for an indication other than the Renal Indication, Licensor must provide Licensee with written notice of its election to exercise such co-promotion right with respect to any of [***],[***],[***], and [***].

  • Following the successful completion by Licensor of the Initial Development Activities in accordance with the Initial Development Plan, Licensee shall file for, prosecute and use Commercially Reasonable Efforts to obtain Regulatory Approvals for the initial Licensed Product for the Renal Indication in each Major Market.

  • No milestone payments shall be payable with respect to: (i) any Licensed Product containing a Backup Compound, or (ii) any Licensed Product containing a Collaboration Compound for a Renal Indication.

  • In the event of a Compound Failure as determined under Section 5.10.2, Licensor will provide Licensee with all material Information regarding any Targeted AIMs (other than compounds that are then Licensed Compounds) Controlled by Licensor or an Affiliate with respect to which Licensor or any Affiliate is then performing or proposes to perform any pre-clinical or clinical development for any Renal Indication (each such compound, a “Backup Candidate”).

  • Endeavor is well along in work on its Meridian solution, and ExLibris is developing a module called Verde.Despite the hard work and accomplishments of DLF ERMI, the final report summarizes substantial issues that still need attention:www.techsource.ala.org• DLF-ERMI did not address support for consortium information management needs.• The place of usage data in ERM systems was not fully explored.

  • No later than thirty (30) days following the filing by Licensee of the first MAA with the EMA for the Licensed Product containing the Initial Licensed Compound for the Renal Indication, Licensee shall pay Licensor a milestone payment equal to (a) Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential.

  • Set forth on Schedule 6.1.2(iv) is a description of the deliverables of Licensor required to enable the filing by Licensee of the first MAA with the EMA for a Licensed Product containing the Initial Licensed Compound for the Renal Indication (“ Licensor EMA Deliverables ”).

  • In the event of a Compound Failure as determined under Section 5.10.2, Licensor will provide Licensee with all material Information regarding any Targeted AIMs (other than compounds that are then Licensed Compounds) Controlled by Licensor or an Affiliate with respect to which Licensor or any Affiliate is then performing or proposes to perform any pre-clinical or clinical development for any Renal Indication (each such compound, a “ Backup Candidate ”).

Related to Renal Indication

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

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

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

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

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

  • 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.

  • 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.

  • Licensed Compound means [***].

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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”).

  • Second Indication means [***].

  • 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.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • 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.

  • 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 Trial means any human clinical trial of a Product.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • 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).