Target Indications definition

Target Indications means […***…].
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Target Indications shall have the meaning assigned to such term in Section 2.1(c).
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Target Indications means the diagnosis, therapeutic treatment and/or prevention of narcolepsy (including Type 1 (with cataplexy) and Type 2 and the sleepiness associated therewith) [***], and (b) any other Additional Indication(s) added to this Agreement pursuant to Section 4.3.
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Examples of Target Indications in a sentence

  • Gilead shall use Commercially Reasonable Efforts to Commercialize the first Licensed Product in each of the Major Markets in the Licensed Territory for each of the Target Indications.

  • Ultimately, advances towards more comprehensive networks have resulted in tools for the prediction of new treatments given a certain disease, known as Drug Target Indications (DTI).

  • Gilead shall be primarily responsible for Development and seeking Regulatory Approval of the Licensed Product and Gilead Combination Products in the Territory and shall use Commercially Reasonable Efforts with respect thereto for the first Licensed Product in each of the Major Markets in each of the Target Indications.

  • During the Discovery Term for each Collaboration Target and the Discovery Program that is directed to such Collaboration Target, the Discovery Plan shall specify that the primary Target Indication for such Collaboration Target, and the Discovery Program shall be in the Oncology Field (it being understood that after the Discovery Term, the Development Plan for any Licensed Program may specify other Target Indications outside of the Oncology Field).

  • Target Indications Our initial target indications for KSI-301 are wet AMD and DR.

  • Gilead shall use Commercially Reasonable Efforts to Commercialize the first Licensed Product in each of the Major Markets for each of the Target Indications.

  • Target Indications for SeladelparWe are actively pursuing PBC as our initial launch indication for seladelpar.

  • The Parties shall discuss the OSA Proposal in good faith and, if the Parties mutually agree upon a go-to-market Commercialization plan for the OSA Target Indications (whether incorporating, in whole or in part, the elements of the OSA Proposal or otherwise), the Initial Commercialization Plan shall be amended by mutual written agreement of the Parties to reflect such mutually agreed upon go-to-market Commercialization plan.

  • The Parties acknowledge and agree that each Program shall initially be directed towards Target Indications in the Oncology Field.

  • Notwithstanding anything to the contrary in this Agreement, the immediately foregoing obligation with respect to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to Development of Licensed Products and Gilead Combination Products, and Gilead shall have the sole * Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission.


More Definitions of Target Indications

Target Indications means the following Respiratory Indications: [***].
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Target Indications means the treatment or prevention of (a) Narcolepsy, including treatment of Cataplexy (“Narcolepsy with Cataplexy” or Type 1); (b) excessive daytime sleepiness (“EDS” or Type 2); (c) obstructive sleep apnea (“OSA”); and (d) idiopathic hypersomnia (“IH”).
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Target Indications means the diagnosis, therapeutic treatment and/or prevention of narcolepsy (including Type 1 (with cataplexy) and Type 2 and the sleepiness associated therewith) [***], and (b) any other Additional Indication(s) added to this Agreement pursuant to Section 4.3. ​ ​
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Target Indications means the following Respiratory Indications: Respiratory Distress Syndrome (RDS); Chronic Lung Disease (BPD); Transient Tachypnea; Hypoxemia; Pulmonary Hypertension; Pneumonia; Bronchiolitis; Diaphragmatic Hernia; Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS); Lung Transplantation; Respiratory Syncitial Virus (RSV); and, Cystic Fibrosis.
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Related to Target Indications

  • 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.

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • Second Indication means [***].

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

  • 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.

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

  • 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”).

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Development Milestone is defined in Section 5.3.

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

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • 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)).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • Major Market Countries means [***].

  • 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:

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • 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.

  • Nicotine product means the same as that term is defined in Section 76-10-101.

  • Regulatory Approval means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a product in a country or group of countries.

  • 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.

  • 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).

  • KPI Target means the acceptable performance level for a KPI as set out in relation to each KPI;

  • 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.

  • 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.