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 has the meaning set forth in Section 5.2.
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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.

  • 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 [********].

  • 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) 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”).

  • Once Immune Design has notified IDRI that it intends to exercise the Exclusive Option with respect to an Option Indication, all of IDRI’s rights with respect to such Option Indication will be exclusively licensed to Immune Design on the terms and subject to the conditions set forth herein and such Option Indication will be deemed included in the Immune Design Exclusive Field.

  • If Licensee exercises such Non-Exclusive DRG Option, then the license grant set forth in Section 5.8.1(d) shall come into effect upon Penn’s receipt of payment of the Non-Exclusive DRG Option Fee with respect to such Licensee Product Option Indication.

  • In addition, and as further consideration for the DRG Technology License set forth in Section 5.8.1(d), on a Licensee Product-by-Licensee Product basis for each Licensee Product Option Indication and during the applicable Licensee Product Royalty Period, Licensee shall pay to Penn a non-refundable, non-creditable royalty of [***] of worldwide Net Sales of Licensee Product for such Licensee Product Option Indication.

  • Licensee may exercise the Non- Exclusive DRG Option by providing written notice to Penn of exercise of such Non- Exclusive DRG Option during the Non-Exclusive DRG Option Period identifying the specific Licensee Product Option Indication subject to such exercise.

  • In the event that GLA and SLA have the same Option Indication, Immune Design’s exercise of the Exclusive Option with respect to such Option Indication, shall be deemed an exercise as to both agents.


More Definitions of Option Indication

Option Indication means each Indication designated in writing by Biogen Idec in connection with its exercise of an Option Right.
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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.

  • 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.

  • 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.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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.

  • POC (Proof of Concept) means testing the Software for evaluation purposes.

  • 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 for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

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

  • 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.