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.
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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.
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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.
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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.

  • 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.

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

  • 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”).

  • At any time following designation of the initial Retained Compound pursuant to Section 4.2(b), Incyte shall have the right to select [ * ] Arginase Inhibitor in the then-current Arginase Inhibitor Pool (i.e., in addition to the Lead Licensed Compound or Back-up Licensed Compound) [ * ] on written notice to Calithera.

  • 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).

  • 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 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.

  • 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.

  • 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.


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.
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Lead Licensed Compound means the compound tenapanor, as further described on Exhibit A to the License Agreement, and any [***] of such compound.
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Related to Lead Licensed Compound

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • 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 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.

  • 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.

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

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

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

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

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • 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 Patent Rights means Patent Rights claiming Collaboration Know-How.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • 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.

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

  • 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.

  • Collaboration Patents means any and all Patents that claim or cover any of the Collaboration Know-How.

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

  • 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.

  • 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 producer means an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Compounds means any or all of the following chemicals, as the context requires:

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.