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.
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Examples of SMA Licensed Product in a sentence

  • First Regulatory Approval in the United States of an SMA Licensed Product $ [***] (ii) First occurrence of both (a) Regulatory Approval by the $ [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • Within [***] after the Option Exercise Date for an SMA Licensed Product, Voyager shall prepare and provide to Genzyme a draft plan for the transition of the Development of such SMA Licensed Product from Voyager to Genzyme (a “Transition Plan”).

  • 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.

  • Genzyme shall provide Voyager with written notice of First Commercial Sale of the SMA Licensed Product within [***] of such First Commercial Sale.

  • The Transition Plan for each SMA Licensed Product shall also describe any Development activities with respect to such SMA Licensed Product that Voyager is required to perform as requested by Genzyme and mutually agreed upon by the Parties (“Transition Activities”).

  • The SMAC shall be an advisory committee for the Collaboration and to the AJSC and shall not have any decision-making authority with respect to any matters under this Agreement; provided, however, that the SMAC shall have the authority to approve the Transition Plan for an SMA Licensed Product.

  • The license granted under the foregoing clause (a) shall be royalty-bearing for the Royalty Term applicable to each SMA Licensed Product in each country in the world, and, after the Royalty Term applicable to such SMA Licensed Product in such country, shall convert to a fully-paid perpetual exclusive license to Commercialize such SMA Licensed Product in the Field in such country.

  • 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.

  • Following the Option Exercise Date with respect to an SMA Licensed Product, Genzyme shall provide the SMAC with a summary work plan and timetable for the Development activities expected to be undertaken with respect to such SMA Licensed Product worldwide (a “SMA Global Development Plan”).

  • If, following the completion of the Transition Plan with respect to an SMA Licensed Product, Voyager discovers that it Controls or possesses any Development Information with respect to such SMA Licensed Product that should have been transferred by Voyager to Genzyme under the Transition Plan but that was not so transferred, Voyager shall promptly provide such Development Information to Genzyme.