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

  • 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.

  • 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 [***].

  • 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.

  • 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.

  • 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”).

  • It is understood that in no event shall OBI be obligated to make the payment due on any milestone more than once with respect to the same Licensed Product (or its Replacement Compound) in connection with either the Renal Indication or the Neural Indication, regardless of the number of indications with the Renal Indication or Neural Indication for which such Licensed Product is developed.

  • 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.

  • 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, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

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

  • 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 a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed 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).

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

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).