Initial Licensed Compound definition

Initial Licensed Compound means the pharmaceutical compound bardoxolone methyl, and any metabolite, salt, hydrate, solvate, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro drug (including ester pro drug) form, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form thereof.
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Initial Licensed Compound has the meaning set forth in the definition of “Licensed Compound.”
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Initial Licensed Compound has the meaning set forth in Section 1.82.
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Examples of Initial Licensed Compound in a sentence

  • In the event that a Party not listed in the Register determines that it requires the use of PFOS, its salts or PFOSF for the acceptable purposes listed in part I of this annex, it shall notify the Secretariat as soon as possible in order to have its name added forthwith to the Register.

  • Notwithstanding the foregoing, Licensor shall have a limited license and right to access, use and reference, solely to grant a sublicense and provide a right of access, use and reference to Kyowa with respect to any such Regulatory Data or Regulatory Documentation pertaining to any Licensed Product containing the Initial Licensed Compound or any Backup Compound, as and to the extent required under the Kyowa Agreement as determined by Licensor in good faith.

  • Licensor shall not be required to allocate such supply to Licensee in a manner that would have an adverse effect on the quantity of Initial Licensed Compound available to Licensor as necessary to fulfill Licensor’s obligations under the Initial Development Plan.

  • Licensor has granted exclusive licenses to the Initial Licensed Compound, back-up compounds thereto, and certain related compounds and product containing the foregoing compounds to Kyowa pursuant to the Kyowa Agreement, a redacted copy of which has been delivered to Licensee.

  • The payment provided for in this Section 6.1.7 shall be payable no more than once, and shall not apply to any Licensed Product which does not contain the Initial Licensed Compound.

  • For example, if Net Sales for all Licensed Products containing the Initial Licensed Compound in the Licensee Territory during a Calendar Year are $2,000,000,000, and Net Sales during for all Licensed Products containing a Licensed Compound different from the Initial Licensed Compound in the Licensee Territory during such Calendar Year are $2,500,000,000, then all such Net Sales for both sets of Licensed Products during such Calendar Year shall bear a royalty rate of 20%.

  • Either Party, directly or through its representatives on the JDC, may propose amendments to the Initial Development Plan to the JDC from time to time as appropriate, including in light of changed circumstances or to propose additional Initial Development Activities for a Licensed Product containing the Initial Licensed Compound or a Backup Compound.

  • If the payment under Section 6.1.2(iii) was due, then, no later than thirty (30) days following the receipt by Licensee of Regulatory Approval in each [Major Market] for the first Licensed Product containing the Initial Licensed Compound that meets the Target CKD Approval Profile in each of the five (5) Major Markets, Licensee shall pay Licensor the following milestone payment for each such country.

  • Compound that is then the subject of the Initial Development Plan (whether such Licensed Compound is the Initial Licensed Compound or a Backup Compound deemed a Licensed Compound pursuant to this Section 5.10.2 following a previous Compound Failure), and to provide for the Development of the Backup Compound.

  • Within [Redacted] after the Effective Date, the Parties will establish a Joint Project Team for the Initial Licensed Compound (the “Joint Project Team” or “JPT”), which shall consist of an equal number representatives from each of the Parties, such number to be determined by the JGC.

Related to Initial Licensed Compound

  • Licensed Compound means [***].

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

  • Initial license means the first permanent license granted to a qualified individual.

  • 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.

  • 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.

  • Commercial License means any license issued to an individual or entity that is not a patient, caregiver, or transporter agent.

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

  • 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 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.

  • 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.

  • 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.

  • 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.

  • GSK has the meaning set forth in the preamble.

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

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

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

  • 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.

  • 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.

  • 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.

  • Retail license means one of the following licenses issued under this title:

  • Licensed Field means all fields of use.