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

  • 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.

  • Licensee hereby consents to Licensor’s performance of its obligations to consult and coordinate with Kyowa regarding the worldwide Development and Commercialization of the Initial Licensed Compound and such other compounds and products containing such compounds, and to provide information to Kyowa regarding the Licensed Compounds and Licensed Products, all to the extent provided in the redacted Kyowa Agreement provided to Licensee as of the Execution Date.

  • 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.

  • 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.

  • 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.

  • 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.

  • Each Party’s JPT representatives shall include (a) key member(s) of each formed Working Group, if any, (b) any representatives of any other functions relevant for the advancement of the Initial Licensed Compound, and (c) a program team leader and project manager from each Party.

  • 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.

  • AbbVie acknowledges that I-Mab has submitted an application for Lemzoparlimab as the International Nonproprietary Name for the Initial Licensed Compound and has received approval therefor.

Related to Initial 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 a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Exempt compound means the same as defined in Rule 2.

  • 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.

  • 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 and on a country-by-country basis, a product that [***].

  • 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

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • 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 activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Licensed Field means [***].

  • Licensed Territory means worldwide.