Lead Licensed Compound definition

Lead Licensed Compound means initially, JCN068, or any Back-up Compound that is developed instead of JCN068 or its replacement Back-up Compound, and all prodrugs, metabolites, stereoisomers, diastereomers, enantiomers, tautomers, solvates, hydrate forms, homologs, salt forms, labeled forms (e.g., deuterated, 13C enriched, etc.), esters, crystalline forms (e.g., polymorphs), semi-crystalline forms, and amorphous forms, of such compound.
View Source
Lead Licensed Compound means the NHE3 inhibitor designated as RDX5791, which is the subject of the IBS-C IND and the Cardio/Renal IND, and any metabolites, salts, esters, free acid forms, crystal forms, free base forms, pro-drug forms, racemates and all optically active forms thereof.
View Source
Lead Licensed Compound means any compound in the Arginase Inhibitor Pool selected by Incyte and designated as its lead Licensed Compound for Development in the Hematology/Oncology Field pursuant to Section 4.2, as same may be substituted from time to time during the Term by Incyte upon written notification to Calithera pursuant to Section 4.2; provided that as of the Execution Date, the “Lead Licensed Compound” is the Licensed Compound that includes the Arginase Inhibitor commonly known as CB-1158 (“CB-1158”). There may be only one Lead Licensed Compound at any time.
View Source

Examples of Lead Licensed Compound in a sentence

  • Erasca shall have the right during the Term prior to the first Regulatory Approval of any Licensed Product to conduct research and development activities to select Back-up Compounds to replace potentially the then-existing Lead Licensed Compound due to concerns regarding the safety, efficacy, or competitiveness of such Lead Licensed Compound, or other scientific, medical or intellectual property matters relating to such Lead Licensed Compound.

  • Ardelyx will use subcontractors to manufacture and supply Lead Licensed Product and Lead Licensed Compound for use by the Parties under the Main Agreement, and Ardelyx shall enter into, or maintain contractual relationships with its subcontractors that are consistent with the provisions set forth herein.

  • If in performing activities with respect to Back-up Compounds as permitted in this Section 2.6, Erasca determines that it desires to, and develops plans to, commercialize Licensed Products containing the then-existing Lead Licensed Compound as well as Licensed Products containing one or more other Licensed Compounds, Erasca shall so notify the PAC, in which case the Parties shall negotiate an agreement to enable Erasca to do so pursuant to the procedures set in Section 2.6(d).

  • Any replacement of a Lead Licensed Compound with a Back-up Compound shall be effective upon Erasca’s delivery of written notice that Erasca is replacing such Lead Licensed Compound with a Back-up Compound to Katmai, in which case the prior Lead Licensed Compound shall immediately be deemed a Back-up Compound and the selected Back-up Compound shall become the Lead Licensed Compound.

  • The QAA shall further include provisions obligating Ardelyx to report to AstraZeneca any regulatory compliance issues with its suppliers as well as any critical quality non-conformances relating to the Lead Licensed Compound or Lead Licensed Product.

  • After the Effective Date, and promptly following AstraZeneca’s request to do so, Ardelyx shall transfer to AstraZeneca copies of all of the “Essential Documents” as defined in Chapter 8 of ICH-GCP that are Controlled by Ardelyx relating to the Lead Licensed Compound and Lead Licensed Product (the “Essential Documents”).

  • The Initial Supply from Ardelyx to AstraZeneca, or to Ardelyx internally where Ardelyx has been assigned (either by the DCC or under the terms of the Agreement) the lead responsibility for the conduct of the Clinical Trial for which the supply is intended, shall include those GMP quantities of Lead Licensed Compound or Lead Licensed Product, and those development activities, in either case, approved by the DCC.

  • Right of Setoff...........................................................................84 SECTION 9.07.

  • The Initial Supply shall include, unless otherwise determined by the DCC, those quantities of Lead Licensed Product and Lead Licensed Compound and those activities described on Exhibit J.

  • The QAA shall further include provisions obligating AstraZeneca to report to Ardelyx any regulatory compliance issues with respect to AstraZeneca and/or its suppliers with respect to the Lead Licensed Compound and the Lead Licensed Product, as well as any critical quality non-conformances relating to the Lead Licensed Compound or Lead Licensed Product.


More Definitions of Lead Licensed Compound

Lead Licensed Compound means the compound of Ardelyx, known as tenapanor, having the structure set forth on Exhibit A, and any [***] of such compound.
View Source
Lead Licensed Compound means the compound tenapanor, as further described on Exhibit A to the License Agreement, and any [***] of such compound.
View Source

Related to Lead Licensed Compound

  • Licensed Compound means [***].

  • 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 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)).

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

  • 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.