CS3 Study definition

CS3 Study means the Clinical Study identified in the ISIS-SMNRx Development Plan as the “CS3” study or the “CS-3” study.
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CS3 Study means ISIS-505358 CS3, A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose‑Escalation Study to Examine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ISIS 505358 in Treatment-Naïve Patients with Chronic Hepatitis B Virus Infection
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Examples of CS3 Study in a sentence

  • Biogen Idec desires Isis to Develop ISIS 396443 through completion of both the CS3 Study and the CS4 Study, and to have an Option to obtain an exclusive license under this Agreement to Develop, Manufacture and Commercialize Products in the Field.

  • Shift schedules will adhere to all regulations in this Agreement unless prior agreement by the Union has been obtained in writing.

  • GSK will contract with a Third Party contractor to package and label the Ionis HBV Lead Compound Supply to be used in the CS3 Study.

  • As soon as reasonably practicable following the Completion of the CS3 Study, Ionis shall transfer the IND for the HBV Lead Compound to GSK, and Ionis and GSK will coordinate on the timing and activities required by each Party to transfer to GSK the IND and other regulatory filings for the HBV Lead Compound.

  • If the Parties mutually agree to use any portion of Commercial Supplies for the CS3 Study and/or the CS4 Study, Isis and Biogen Idec will cooperate in good faith and mutually agree on an appropriate [***] (if any) from Isis to Biogen Idec for such Commercial Supplies, based on the premise that Biogen Idec is responsible for [***].

  • As soon as reasonably practicable following the Completion of the CS3 Study, GSK will promptly [***], and thereafter will update such [***] on at least an annual basis until such time as the HBV Option is exercised (or otherwise expires).

  • If Biogen Idec exercises its Option after receiving a PoC Trial Completion Notice but before completion of both the CS3 Study and the CS4 Study, Isis will complete the remaining study in accordance with Section 1.3 [***].

  • Until the Completion of the CS3 Study, Ionis shall remain the study sponsor for the conduct of the CS3 Study, and will maintain all regulatory filings (including the IND) for the CS3 Study in good standing.

  • As the study sponsor, until the Completion of the CS3 Study, Ionis shall be responsible for, and will use Commercially Reasonable Efforts to conduct, [***], including approval of all [***] and all [***] related to the CS3 Study as required by the applicable Regulatory Authorities.

  • As between GSK and Ionis, GSK shall be responsible for, and will [***] to provide the day-to-day oversight and management of the CRO in the performance of its obligations for the CS3 Study, as set forth under the Clinical Study Agreement.

Related to CS3 Study

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).