Licensed API definition

Licensed API means API that is either (a) made by Licensee pursuant to the license grant in Section 2.1; or (b) acquired by Licensee from a Gilead Supplier or from a Licensed API Supplier on the terms and conditions set forth in Section 3.
Licensed API means (i) prior to the filing of the Progeria NDA, the active pharmaceutical ingredient of the Licensed Compound in the form as previously supplied to PRF by Eiger prior to the Effective Date or (ii) following the filing of the Progeria NDA, the form of the active pharmaceutical ingredient of the Licensed Compound used for the Licensed Progeria Product under the Progeria NDA.
Licensed API has the meaning set forth in Section 2.

Examples of Licensed API in a sentence

  • If Licensee wishes to manufacture Product using API made by either a Gilead Supplier or a Licensed API Supplier, then Licensee shall notify Gilead in writing, and shall certify that its arrangement with such Gilead Supplier or Licensed API Supplier, as applicable, is consistent with the terms and conditions of this Agreement.

  • Licensee shall provide Gilead with written copies of all agreements between Licensee and such Gilead Supplier or Licensed API Supplier upon execution.

  • Gilead shall not be obligated to assist Licensee in procuring any supply of API from a Licensed API Supplier.

  • In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, Gilead shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier.

  • Licensee agrees that it shall not make or use any API other than API that is Licensed API for the manufacture of any Product for sale in the Territory.

  • Licensee agrees that it shall not make, use or sell any Product that contains API other than API that is Licensed API.

  • Upon receipt of a notice described in Section 3.1 of Licensee’s intention to obtain Licensed API, other than TAF, from a Gilead Supplier, Gilead shall use commercially reasonable efforts to assist Licensee in procuring supply of such API from such Gilead Supplier.

  • Gilead shall not be obligated to assist Licensee in procuring any supply of such API from a Licensed API Supplier.

  • Licensee agrees that it shall not make any API other than API that is Licensed API for the manufacture of any Product for sale in the Territory.

  • Upon Gilead’s receipt from Licensee of a written notice describing its intention to obtain Licensed API from a Gilead Supplier as described in Section 3.1, Gilead shall use commercially reasonable efforts to assist Licensee in procuring supply of API from such Gilead Supplier.


More Definitions of Licensed API

Licensed API means (a) that composition of matter with the chemical structure identified more specifically in Exhibit A, otherwise known as lurbinectedin (PM1183); (b) any [***]; (c) any pro-drug, metabolite or degradant of any of the foregoing; or (d) any salt, free acid or base, crystal, co-crystal, hydrate, anhydrous form, solvate, ester, polymorph, isomer, regioisomer or stereoisomer (including enantiomer and diastereoisomer) of any of the foregoing.
Licensed API has the meaning set forth in Section 3.
Licensed API means all Intellectual Property owned or controlled by the Aspen Group that relates to the APIs, including but not limited to Heparin, Fondaparinux Crude, Fondaparinux Sodium, Danaparoid Crude, Danaparoid Sodium, Nadroparin and Certoparin;
Licensed API means an API which is the subject of Valid Claims in the Licensed Patents.

Related to Licensed API

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • Licensed Technology means the Licensed Patents and the Licensed Know-How.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • 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.

  • Licensed System means, collectively:

  • Licensed Field means all fields of use.

  • Licensed Field of Use means all fields.

  • 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.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

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

  • 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.

  • Product Technology means the Product Know-How and Product Patents.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Licensor Technology means the Licensor Patents and the Licensor Know-How.

  • Licensed Materials means any materials that Executive utilizes for the benefit of the Company (or any Subsidiary thereof), or delivers to the Company or the Company’s Customers, which (a) do not constitute Work Product, (b) are created by Executive or of which Executive is otherwise in lawful possession and (c) Executive may lawfully utilize for the benefit of, or distribute to, the Company or the Company’s Customers.

  • Hemp products means all products made from industrial hemp,

  • Licensed Know-How means all Know-How that (a) is Controlled by Pfizer or any of its Affiliates as of the effective date of the Pfizer-MPP Agreement, (b) directly relates to the use of the Compound, Product or Licensed Product in the Field, and (c) is not in the public domain or otherwise generally known. For the avoidance of doubt, (i) Licensed Know-How shall not include any Know-How to the extent solely and directly related to any other Pfizer compound or to the extent related to the use of the Compound, Product or Licensed Product outside the Field and (ii) Licensed Know-How includes only that Know-How, designated by Pfizer in its sole discretion, necessary for the manufacture, registration and commercialization of the Compound and/or Licensed Product for use in the Field. For the avoidance of doubt, Licensed Know-How excludes any Know-How related to ritonavir that has been (either as of the Effective Date or at any time during the term of this Agreement) in-licensed by Pfizer from any Third Party.

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

  • Licensed Compound means [***].

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Licensee Technology means the Licensee Know-How and Licensee Patents.

  • 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.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Licensed Territory means worldwide.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Licensed Material means the artistic or literary work, database, or other material to which the Licensor applied this Public License.