Core Indications definition

Core Indications means those Indications for which the Parties wish to jointly develop the Product as part of their Core Development activities hereunder, which Indications are identified as Core Indications in the Initial Development Plan and Budget, together with such additional Indications as may be identified as Core Indications in the Core Development Plan as updated and modified from time to time in accordance with this Agreement.
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Core Indications means (i) the use and application of clinical development programs of Vibegron for over-active bladder and over-active bladder in men with benign prostatic hyperplasia indications, and (ii) after the approval of the New Drug Application for Vibegron, the commercialization of Vibegron to the urologist physician market segment for such indications.
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Core Indications means ABSSSI and Pneumonia.
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Examples of Core Indications in a sentence

  • Note: It is highly recommended that the Mathematical Method for entrance and exit holes be corroborated using the Dowel and String Method.

  • In all, attaining powers of the self, accepting freedom of choice and the responsibility this entails illustrate a capital telos of the SP pedagogy and governing rationale: self-regulation and self-governing.

  • Implementation of the National Core Indications has helped DODD continue to measure system performance and make improvements that will better support individuals with developmental disabilities and their families in Ohio.

  • Without limiting anything in this Section 5.1, it is the intention of the Parties to seek Regulatory Approval for the Core Indications and to use Commercially Reasonable Efforts to engage in the Regulatory Activities in support of obtaining such Regulatory Approvals, in the Territory.

  • Milestone Payments to FibroGen for Approval Success: Astellas shall pay FibroGen $[ * ] US dollars upon granting of each of the first three Marketing Approvals in the Core Indications (except for [ * ]) in the EU (for a total aggregate amount of $[ * ] US dollars).

  • Notwithstanding the foregoing, if Bayer does not receive a CPP from the FDA or the EMA, Trius shall prepare, file, obtain, maintain and be the holder of the Regulatory Approval for Product in the Field in China and those other countries of the Bayer Territory which require CPP ownership for obtaining Regulatory Approval for each of the Core Indications.

  • From and after the Effective Date, Schering will assume responsibility and control of the execution of all Development activities related to the Licensed Product under the oversight of the JDC and in accordance with the Core Development Plan, provided, however, that the Parties will agree upon and set forth, in the Core Development Plan, any specific activities to be performed by Novacea (to be reimbursed at the FTE Rate) relating to the Development of the Licensed Product in the Core Indications.

  • Trius shall be the sponsor of the Global Trials in the Core Indications, and shall be responsible for conducting or having conducted, and shall use Commercially Reasonable Efforts to conduct, or have conducted, each Global Trial in accordance with the Global Development Plan.

  • For clarity, Schering shall not be obligated to undertake Development and/or Commercialization of the Licensed Product for indications outside of the Core Indications.

  • Bayer shall use Commercially Reasonable Efforts to develop, register and commercialize Product for the Core Indications in […***…] the Bayer Territory […***…].


More Definitions of Core Indications

Core Indications means each of the following Indications: (i) ALPS, (ii) ADPKD, [***].
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Core Indications means the indications of ISR, SV and BtK.
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Related to Core Indications

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

  • Second Indication means [***].

  • 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.

  • Therapeutically equivalent drug products means drug products that contain the same active

  • 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.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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.

  • 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.

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

  • 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.

  • 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:

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

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

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

  • 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)).

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • 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.

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

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.

  • 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.

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

  • Competing Product means […***…].

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.