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.
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Examples of Licensed Progeria Product in a sentence

  • Eiger agrees that, if, for any reason, Eiger Defaults (as defined below) on any of its obligations to supply any Licensed Progeria Product to PRF in accordance with this Agreement, and fails to cure such Default within [ * ] after its receipt from PRF of a written notice describing such Default, PRF has the right to obtain such Licensed Progeria Product or Licensed API from such PRF Second Source.

  • Upon the reasonable written request of PRF, Eiger shall make available to PRF records of the Licensed Product reasonably necessary for PRF to fulfill its regulatory requirements with respect to its use of the Licensed Progeria Product in the Field.

  • 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.

  • For the avoidance of doubt, any such remaining inventory of Licensed Progeria Product assigned to PRF other than the safety stock maintained by Eiger pursuant to Section 9(h) shall be delivered on an “as is” basis without warranty of any kind, and PRF shall be responsible for requalification or other requirements for research use or use in humans under any applicable laws, rules and regulations with respect to such remaining inventory.

  • The trial court denied relief on October 14, 2003 (Petitioner’s appendix, p.14).

  • Huffington Post, March 21, 2010, http://www.huffingtonpost.com/jim-luce/roshan-cell-phone- company_b_507554.html.

  • 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).

  • Any notice of rejection from PRF must contain reasonable documentation to allow Eiger to reasonably determine whether such rejected Licensed Progeria Product is a Non-Conforming Product.

  • The most annoying aspect of their work is excessive red tape, and respondents agree that a major problem rests with this body.

  • 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.

Related to Licensed Progeria Product

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • 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 In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • 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 (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • 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 performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.

  • 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)).