Registration-Directed Trial definition

Registration-Directed Trial means a pivotal Clinical Study (whether or not called a “Phase 3” Clinical Study) [***] intended to establish that a Product is safe and effective for its intended use; and is intended to support NDA filing (or foreign equivalent filing) of such Product in patients having the disease or condition being studied, as described in 21 C.F.R. § 312.21(c) FDCA, as amended from time to time, or a foreign equivalent thereof.
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Registration-Directed Trial means, with respect to a Product, a human clinical trial (regardless of whether actually designated as “Phase III”) that is prospectively designed, along with other Phase III Clinical Trials, to demonstrate statistically whether such Product is safe and effective for use in humans in the indication being investigated as described in 21 C.F.R. §312.21(c), or an equivalent clinical trial in a country in the Territory other than the United States.
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Registration-Directed Trial means a pivotal Clinical Study (whether or not denominated as a “Phase 3” Clinical Study under applicable regulations) in human patients that is of the size and design intended to establish that a Product is safe and effective for its intended use; to define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be prescribed; and is intended to support Approval of such Product. “Phase 3 Trial” or “Registration-Directed Trial” includes any clinical study designated under a Collaboration Plan as a “Phase 3 Trial,” “Phase 3 Study” or “Registration Trial.”
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Examples of Registration-Directed Trial in a sentence

  • The Registration-Directed Trials will be designed in accordance with the Registration-Directed Trial designs set forth in the applicable IDCP.

  • Promptly after such notice, once the data generated under the statistical analysis plan for a Registration-Directed Trial is available to Roche, Roche will provide such data to Isis.

  • Prior to Initiation of the first Registration-Directed Trial for a given Product, Roche will prepare a Development and global integrated development and commercialization plan (“IDCP”) outlining key aspects for Developing such Product through Approval, and Roche’s worldwide strategy to launch and Commercialize such Product.

  • Roche will notify ▇▇▇▇ in writing promptly after Roche completes each Registration-Directed Trial under the applicable IDCP.

  • Roche will notify Isis in writing promptly after Roche completes each Registration-Directed Trial under the applicable IDCP.

  • Roche will keep Isis informed of the progress and status of each Registration-Directed Trial.

  • Initiation of the Registration-Directed Trial for [***] is at the sole discretion of Roche.

  • Roche will keep Ionis informed of the progress and status of each Registration-Directed Trial.

  • Prior to Initiation of the first Registration-Directed Trial for a given Product, Roche will prepare a global integrated development and commercialization plan (“IDCP”) outlining key aspects for Developing such Product through Approval of at least one (1) Indication, and Roche’s worldwide strategy to launch and Commercialize such Product.

  • Roche will notify Ionis in writing promptly after Roche completes each Registration-Directed Trial under the applicable IDCP.