Option Compound Candidate Drug definition

Option Compound Candidate Drug means each (a) IND-Ready Option Candidate Drug, (b) POC Option Candidate Drug and (c) each Licensed Derivative with respect to any such IND-Ready Option Candidate Drug or POC Option Candidate Drug made by or on behalf of AstraZeneca or any of its Affiliates or Sublicensees and (d) in each case ((a) through (c)), any salt form, polymorph, crystalline form, hydrate, solvate or formulation thereof.
Sample 1

Examples of Option Compound Candidate Drug in a sentence

  • 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, if prior to the Schizophrenia Expiration Date, AstraZeneca has exercised an Option for an Option Compound Candidate Drug for which Schizophrenia is a Principal Indication or AstraZeneca otherwise Commercializes an Option Compound Product for Schizophrenia there shall be no Schizophrenia Expiration Date.

  • For purposes of clarity, if prior to the Schizophrenia Expiration Date, AstraZeneca has exercised an Option for an Option Compound Candidate Drug for which Schizophrenia is a Principal Indication or AstraZeneca otherwise Commercializes an Option Compound Product for Schizophrenia, there shall be no Schizophrenia Expiration Date.

  • For purposes of clarity, if prior to [********], AstraZeneca has exercised an Option for an Option Compound Candidate Drug for which [********] or AstraZeneca otherwise Commercializes an Option Compound Product for [********].

  • For purposes of clarity, if prior to [********], AstraZeneca has exercised an Option for an Option Compound Candidate Drug for which [********] or AstraZeneca otherwise Commercializes an Option Compound Product for [********], there shall be no Schizophrenia Expiration Date.

  • If Option Compound Proof of Concept is not achieved, AstraZeneca shall promptly notify Targacept in writing thereof and Section 5.10.2(e) shall apply, except that if pursuant to that Section the applicable Option Compound does not become an Option Compound Candidate Drug for any reason, such Option Compound shall, notwithstanding Section 5.10.2(e)(4), become a Terminated Compound (but not a Terminated AZ Compound) and [********].

Related to Option Compound Candidate Drug

  • 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)).

  • 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.

  • Licensed Compound means [***].

  • 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.

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

  • 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.

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • 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.

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

  • 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.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Compounds means a small molecule HMT inhibitor.

  • Compound means the taking of two or more ingredients and fabricating them into a single

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

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

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • 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 I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.