Distinct Indication definition

Distinct Indication means, for purposes of determining whether an Indication constitutes the first, second or third Indication, the following: (A) in the case of the Initial Field, (1) each of [*] and any other indication separately listed on Exhibit B (but not those that may be designated as [*], as the case may be) (“CNS Indications”) will be treated as a distinct Indication and (2) any additional and [*] disease, disorder, or illness affecting [*] that is outside of the CNS Indications but in the Initial Field will be treated as a distinct Indication, provided that, for the purpose of this clause (2), [*] will be treated as the same Indication, and (B) in the case of the Expanded Field, (1) each of the Excluded Indications listed on Exhibit A (but not those that may be designated as [*]) will be treated as a distinct Indication and (2) any additional and [*] disease, disorder, or illness affecting [*] that is outside of the Excluded Indications will be treated as a distinct Indication, provided that, for the purpose of this clause (2), [*] will be treated as the same Indication. For the purpose of determining whether a milestone event has been achieved, the milestone event will not be deemed achieved unless the Distinct Indication [*].
Distinct Indication means (a) with respect to Collaboration Target 1, an Indication with a diagnosed prevalence in humans in [***] of no less [***] and (b) with respect to Collaboration Target 2, an Indication with a diagnosed prevalence in human [***] of no less than [***].
Distinct Indication means an indication for the prevention, treatment or control of a disease or condition in humans, which is described in the label for the applicable Product (upon Regulatory Approval for such indication), Regulatory Approval for which requires one or more separate registrational Clinical Trials for such label; provided however, that each such Distinct Indication shall be separate and distinct from each other Distinct Indication. For purposes of this definition, different types, stages, lines of therapy or patient populations for a particular disease shall not be considered to be “separate and distinct” indications from one another, and are not considered separate Distinct Indications (i.e., different types, stages, lines of therapy or patient populations for a particular disease would be considered part of the same Distinct Indication). Accordingly, by way of example, dialated cardiomyopathy and hypertrophic cardiomyopathy would be considered to be “separate and distinct” from one another and each would be considered a separate Distinct Indication. Also, by way of example, the treatment of different types, stages, lines of therapy or patient populations of heart failure would not be considered to be “separate and distinct” indications and would all be included as part of one and the same Distinct Indication.

Examples of Distinct Indication in a sentence

  • In this context, on exactly December 21, 1894, he renewed his Pactum for the second time.First Distinct Indication of the Pactum, February 1895 (II, 82-3).


More Definitions of Distinct Indication

Distinct Indication means an Indication that is separate and distinct from another Indication for a given Product that has received Regulatory Approval.
Distinct Indication has the meaning set forth in Section 1.7(a) hereof.

Related to Distinct 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.

  • 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.

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

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Position indicating device means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

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

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • 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:

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Second Indication means [***].

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • 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 Indication means any indication other than the Initial Indication.

  • Licensed Field means all fields of use.

  • Competing Product means [***].

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

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

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • 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.

  • Commercialized shall have corresponding meanings.

  • 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.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.