HD Licensed Product definition

HD Licensed Product means any Gene Therapy Product that delivers a transgene encoding a molecule that functions to directly or indirectly reduce the levels of mutant huntingtin protein (including any Back-Up Product) if the Split Territory Program Option or the Co-Co Option has been exercised for the HD Collaboration Program, including the Collaboration Product for which such Option was exercised.
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Examples of HD Licensed Product in a sentence

  • The Co-Co Option applies to the HD Collaboration Program, in accordance with Section 3.1.2 (HD Licensed Product Co-Co Option Grant).

  • With respect to each HD Licensed Product, promptly following the end of each Calendar Year, the Head of the Rare Disease Business of Genzyme and an appropriate officer of Voyager shall certify to one another in writing whether or not such Party has incurred the Co-Co Costs allocated to such Party in the applicable U.S. HD Commercialization Budget during such Calendar Year in performing the Co-Co Activities allocated to such Party in the applicable U.S. HD Commercialization Plan.

  • With respect to each HD Licensed Product, unless otherwise agreed to by the Parties in writing, Voyager and Genzyme shall each be responsible for [***] percent ([***]%) of the Co-Co Costs set forth in the U.S. HD Commercialization Budget for such HD Licensed Product.

  • For each HD Licensed Product, the Commercialization activities that are necessary or useful to be undertaken for such HD Licensed Product in the United States will be set forth in reasonable detail in a written work plan (each, a “U.S. HD Commercialization Plan”).

  • She needs low stimulatory sensory tools, such as a mobile, activity play mat, and baby mirror.

  • Genzyme will allow Voyager a reasonable opportunity to review and comment on Genzyme’s proposed response to any Material Communications with the EMA with respect to any Split Territory Licensed Product or, if Genzyme has exercised the Co-Co Option, with the FDA with respect to any HD Licensed Product, in advance of the transmission of such response, and Genzyme will reasonably consider all comments timely provided by Voyager in connection therewith.

  • HD Commercialization Plan for an HD Licensed Product will be prepared by the PSC for the HD Licensed Program no later than [***] of such HD Licensed Product in the United States.

  • Genzyme shall provide Voyager with reasonable advance notice of all formal meetings and teleconferences with the EMA pertaining to any Split Territory Licensed Product or, if Genzyme has exercised the Co-Co Option, with the FDA pertaining to any HD Licensed Product, or with as much advance notice as practicable under the circumstances.

  • Voyager shall provide Genzyme with written notice of any Third Party License Payments made by Voyager with respect to an HD Licensed Product in the United States.

  • Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order to effect a recall of an HD Licensed Product in the United States.

Related to HD Licensed 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.

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

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

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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).

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

  • 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.

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

  • Licensed Field means all fields of use.

  • 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.

  • Licensed Territory means worldwide.

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

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

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

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

  • Third Party Product means a product (whether hardware, software or services) supplied to you by a third party;

  • 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.

  • End product means those articles, materials, and supplies to be acquired under the contract for public use.

  • Licensed Field of Use means all fields.

  • Licensed System means, collectively:

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

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Hemp products means all products made from industrial hemp,

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.