SMA Licensed Product definition

SMA Licensed Product means any Gene Therapy Product that delivers a transgene encoding a molecule that directly or indirectly increases the level of survival motor neuron protein (including any Back-Up Product) if the SMA Program Option has been exercised for the SMA Collaboration Program, including the Collaboration Product for which such Option was exercised.
Sample 1Sample 2Sample 3

Examples of SMA Licensed Product in a sentence

  • The Development of the SMA Licensed Program and the Development and Commercialization of each SMA Licensed Product pursuant to the Collaboration will be conducted under the oversight of the SMAC, which shall be comprised of [***] members, with each Party contributing [***] representatives who are employees of such Party.

  • With respect to any SMA Licensed Product, Genzyme shall be responsible for one-hundred percent (100%) of all Global Development Costs that occur after the Option Exercise Date for such SMA Licensed Product.

  • Voyager’s sole and exclusive remedy for any breach by Genzyme of this Section 7.2.1 with respect to any SMA Licensed Product shall be [***].

  • Following the Transition Period with respect to an SMA Licensed Product, once every Calendar Quarter Genzyme shall provide to Voyager, through the SMAC, an update regarding Development activities conducted by or on behalf of Genzyme with respect to such SMA Licensed Product, as well as any Clinical Studies with respect to such SMA Licensed Product conducted by Genzyme.

  • Voyager shall be responsible for one-hundred percent (100%) of Global Development Costs for such SMA Licensed Product that occur prior to the Option Exercise Date for the SMA Licensed Product for goods and services to be performed prior to the Option Exercise Date.

  • Genzyme shall use Commercially Reasonable Efforts to Develop the SMA Licensed Product and obtain Regulatory Approval therefor in each Genzyme Territory MMC; provided, however, that Voyager’s sole and exclusive remedy for any breach by Genzyme of such obligation to use such Commercially Reasonable Efforts shall be [***].

  • Genzyme shall use Commercially Reasonable Efforts to Commercialize the SMA Licensed Product in each Genzyme Territory MMC where Genzyme has obtained Regulatory Approval and Reimbursement Approval.

  • The classification of such Split Territory Licensed Program (and Split Territory Licensed Products) as an additional SMA Licensed Program (and additional SMA Licensed Program) shall have no effect on any other SMA Licensed Program or SMA Licensed Product.

  • If the SMAC fails to approve a Transition Plan for an SMA Licensed Product within [***] following the Option Exercise Date with respect to such SMA Licensed Product, then the matter shall be submitted to the AJSC for resolution pursuant to Section 9.1.6 (Decision Making).

  • For clarity, Global Development Costs to be paid by Genzyme pursuant to this Section 5.3.4 (Global Development Costs) shall exclude any amounts paid after the Option Exercise Date forthe SMA Licensed Product to Third Parties with respect to services rendered or services procured in connection with the conduct of any Clinical Study or Development activity that, in either case, is completed or performed prior to the Option Exercise Date for the SMA Licensed Product.

Related to SMA 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.

  • 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.

  • 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.

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

  • Licensed Territory means worldwide.

  • Licensed Field means all fields of use.

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

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

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

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

  • 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.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Hemp products means all products made from industrial hemp,

  • 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 Field of Use means all fields.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

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

  • Licensed System means, collectively:

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.