Option Indication definition

Option Indication means any Primary Indication or, prior to the Schizophrenia Expiration Date, Schizophrenia; provided, however, that in no event shall AAMI or MCI be an Option Indication until such time as AAMI or MCI, respectively, is included in DSM-IV, becomes recognized as a distinct diagnosable condition by general consensus in the medical community in the United States, or a product receives Product Regulatory Approval from the FDA in the United States for AAMI or MCI (as applicable).
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Option Indication means each Indication designated in writing by Biogen Idec in connection with its exercise of an Option Right.
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Option Indication shall have the meaning set forth in Section 4.1.
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Examples of Option Indication in a sentence

  • Each Option Compound Development Plan shall specify the standards or criteria that, if achieved, constitute Option Compound Proof of Concept for the Option Indication (i) specified in the applicable IND-Ready Option Notice or (ii) otherwise agreed to by the Parties.

  • Whether or not the Targacept Plan POC Notice specifies that Targacept believes it has achieved Option Compound Proof of Concept for the Option Indication specified in the Targacept Option Compound Development Plan (if any), AstraZeneca shall thereafter have the option to designate such Option Compound as an Option Compound Candidate Drug in accordance with the terms of Section 5.10.2(d)(1).

  • For purposes of clarity, (x) except as permitted under Section 5.10.2(f), AstraZeneca shall not have a POC Option for any Compound other than an Option Compound for which AstraZeneca does not exercise the IND-Ready Option but pays the Option Maintenance Fee and (y) unless otherwise agreed in writing by the Parties, Targacept shall have no right to offer a POC Option for (i) any compound for any indication other than an Option Indication or (ii) any [********].

  • For purposes of clarity, (x) it is contemplated that each IND-Ready Notice will specify [********] Option Indication but, if an IND-Ready Notice specifies [********] Option Indication [********] shall be [********] for purposes of Sections 5.10.2(c)(2) through 5.10.2(c)(5).

  • For purposes of clarity, (x) AstraZeneca shall not have an IND-Ready Option for any Compound other than an Option Compound that becomes IND-Ready and for which Targacept delivers to AstraZeneca an IND-Ready Notice as provided above and (y) unless otherwise agreed in writing by the Parties, Targacept shall have no right to offer an IND-Ready Option for (i) any indication other than an Option Indication or (ii) any [********].

  • If the POC Notice specifies that Targacept has achieved Option Compound Proof of Concept for the Option Indication specified in the Option Compound Development Plan, AstraZeneca shall thereafter have the option under this Section 5.10.2(d) to designate such Option Compound as a Candidate Drug (the “POC Option”).

  • Otherwise, the Principal Indication for such Option Compound Candidate Drug for purposes of this Section 5.10.2(c) shall be the Option Indication that is Developed by AstraZeneca.

  • The Option Exercise Fee shall be determined as follows: Option Exercise Fee = [* * *] [* * *] [* * *] [* * *] [* * *] [* * *] The Option Exercise Fee for any Option Indication shall not be any greater than $[* * *], regardless of its calculated amount.

  • Bahamonde.Title:Personalizacion de Recomendaciones en TripAdvisor Usando Deep Learning.Conference: XIX Conferencia de la Asociaci´on Espan˜ola para la Inteligencia Artificial CAEPIA 20/21, pp 735–740, ISBN: 978-84-09-30514-8, M´alaga, September 2021.

  • To the extent that Lundbeck has made any payments or reimbursements for costs with respect to an Optional Indication pursuant to Article 4.2.1 prior to the payment of the Optional Indication Approval Milestone, such payments shall be credited against the payment of the Optional Indication Approval Milestone (to the extent such Option Indication Approval Milestone becomes payable hereunder).


More Definitions of Option Indication

Option Indication has the meaning set forth in Section 5.2.
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Related to Option Indication

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

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

  • Second Indication means [***].

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

  • 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.

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

  • 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.

  • 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.

  • Participating Product means any of the Breville products listed in the table below by model name and number that are supplied by Breville in Australia and sold directly by Breville or by a Participating Retail Store:

  • 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.

  • 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)).

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • 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.

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

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • POC means Point of Compliance. "POE" means Point of Exposure. "PSI" means pounds per square inch.

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

  • 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:

  • Licensed Compound means [***].

  • Commercial Sale means the sale of Product (as indicated by shipment of Product) to an unaffiliated third-party of the Licensee, or of its sublicensee or distribution partner, such as a wholesaler, managed care organization, hospital or pharmacy and shall exclude (i) any transfer of Product by Licensee to its sublicensee, distribution partner or Affiliate and (ii) any distribution of Product for use in research, development, pre-clinical and clinical trials.

  • 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 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”).

  • 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.

  • 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.

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

  • 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.