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 the indications of ISR, SV and BtK.
Sample 1
Core Indications means each of the following Indications: (i) ALPS, (ii) ADPKD, [***].
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Examples of Core Indications in a sentence

  • The Parties have agreed on the initial Development plan for the Licensed Product in the Core Indications in the Field in the Territory (as may be amended in accordance with this Agreement, the “Core Development Plan”), a copy of which is attached hereto as Exhibit A.

  • 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).

  • 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.

  • The resulting shortage was $2,577.21 ($14,090.46 bank balance -$16,667.67 required balance for this client only).

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

  • 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.

  • 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.

  • 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.


More Definitions of Core Indications

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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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 ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • 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.

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

  • 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: (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”).

  • 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 and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • 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.

  • 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.

  • 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.

  • 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.