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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • During the Term, PRF shall, at Eiger’s sole cost and expense, provide reasonable cooperation and assistance reasonably requested by Eiger with respect to obtaining and maintaining regulatory approvals for an NDA for any Licensed Progeria Product 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).

  • 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.

  • If no such notice of rejection is received by Eiger within the applicable [ * ] day period set forth above, PRF shall be deemed to have accepted such delivery of such Licensed Progeria Product, as the case may be.

  • In the event that any Additional Site is located in a territory where a Licensed Progeria Product does not receive regulatory approval during the Term for commercial sale, Eiger will provide the Licensed Progeria Product [ * ] to such Additional Site for the Term.

Related to Licensed Progeria Product

  • 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.

  • 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 an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

  • 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 [***].

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

  • 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: (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”).

  • Licensed Field means [***].

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

  • 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.