Licensed Progeria Product definition

Licensed Progeria Product means a Licensed Product in finished capsule form containing the Licensed Compound as the sole active pharmaceutical ingredient for use in the Progeria Field”
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Licensed Progeria Product means any Licensed Product in finished capsule form containing lonafarnib as the sole active pharmaceutical ingredient (i) as manufactured and supplied by or on behalf of Eiger to Boston Children’s Hospital pursuant to the Boston Children’s Hospital Investigator Sponsored Clinical Trial Research Agreement, dated October 4, 2016, as amended on October 28, 2016, by and between Eiger and Boston Children’s Hospital or (ii) following the filing of the Progeria NDA, as submitted to the FDA under the Progeria NDA.
Sample 1Sample 2
Licensed Progeria Product means a Licensed Product in finished capsule form containing the Licensed Compound as the sole active pharmaceutical ingredient for use in the Progeria Field” 180288015 v1
Sample 1

Examples of Licensed Progeria Product in a sentence

  • The Sounding Board consists of members from commissions of oversight.

  • In addition, Eiger shall use commercially reasonable efforts to obtain regulatory approval of and Commercialize the Licensed Progeria Product in the Field outside the United States.

  • Following the approval of the Progeria NDA, Eiger agrees to use commercially reasonable efforts to develop and register a [ * ] of the Licensed Progeria Product for use in the Field.

  • Eiger shall deliver the Licensed Progeria Product [ * ] to PRF or its designee (provided that all products in a single order will be delivered to a single place of destination in the U.S.) by PRF’s requested delivery date, provided that with respect to Licensed Progeria Product, PRF supply orders are made in accordance with Section 9(a).

  • For purposes of this Section 8, “commercially reasonable efforts” shall be deemed met if Eiger spends, excluding the costs of manufacturing the Licensed Progeria Product, [ * ] to make the Licensed Progeria Product available as an investigational drug for treatment use in accordance with the foregoing clauses (a) and (b).

  • The Parties further agree to use commercially reasonable efforts to prepare and file NDA equivalents outside of the United States for the Licensed Progeria Product for the treatment of Progeria as determined by the JSC.

  • If no notification is provided from PRF, then Eiger shall ship the Licensed Progeria Product as scheduled, and PRF (or its designee) shall inspect the Licensed Progeria Product upon its receipt thereof.

  • For the avoidance of doubt, such [ * ] excludes the costs of manufacturing the Licensed Progeria Product.

  • Delivery of the Licensed Progeria Product intended to be used for Research Activities outside of the U.S. shall be [ * ] for PRF to undertake export, shipment and delivery outside of the U.S. For clarity, this Section 10 does not apply to, and Eiger remains solely responsible for, the delivery of all Licensed Progeria Product under the global patient support program described in Section 7 and the expanded access or other “named patient” programs described in Section 8.

  • The matter was taken up with the Chief Secretary (August 2006, November 2006, May 2007) also but no action has yet been taken.

Related to Licensed Progeria Product

  • 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 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.

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

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

  • 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.

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

  • Licensed Compound means [***].

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

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

  • Licensed Field means all fields of use.

  • Licensed Territory means worldwide.

  • Licensed Services means all functions performed by the Licensed System.

  • Licensed Service means a service provided using Licensed Products or Licensed Methods, including, without limitation, any such service provided in the form of contract research or other research performed by Licensee on behalf of a third party.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • 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.

  • 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.

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

  • Hemp products means all products made from industrial hemp,

  • Licensed Process means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.

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

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

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

  • Licensed Processes means processes which, in the course of being practiced, 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 Field of Use means all fields.

  • Licensed service area means the geographic area in which the home service provider is authorized by law or contract to provide commercial mobile radio service to the customer.

  • 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)).