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 Compounds”.
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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 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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%.

  • 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.

  • Narrative description of changesin accounting or cost allocation methods made since the institution’s last F&A submission.

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 a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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 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 Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • 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 will have 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.

  • 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.

  • 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.

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

  • 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 all fields of use.