Pharmaceutical Development. 4.10 Pharmaceutical development of the Drug Product will commence as set out in the Development Plan in order to explore alternative formulations of the Drug Product used in the Phase III MC Trial.
Pharmaceutical Development. All results for clevudine drug substance and drug product will be provided. • Excess CTM held by Triangle includes the following. • 13,580 5 mg clevudine capsules • 269 bottles of 50 mg clevudine capsules (30 per bottle) • 40 bottles of 50 mg clevudine capsules labeled for study CLV-202. • 293 bottles of placebo capsules (30 per bottle) The acquisition cost of this material is [BUCKWANG REDACTED] • A total of 41 kg of clevudine drug substance is available. The acquisition cost of this material is [BUCKWANG REDACTED]. • TSIBR intermediate to synthesize clevudine drug substance is available. The acquisition cost of this material needs to be determined. • A complete inventory of all analytical methods is being prepared.
Pharmaceutical Development. Stability studies for drug product, 10 mg capsules and placebo, are ongoing at Triangle. This study will continue at Triangle in support of study FTCB-204 and will not be transferred to Bukwang. Results will be provided to Bukwang as they become available. • A campaign to produce additional CTM at Patheon in August has been cancelled.
Pharmaceutical Development. The main steps of the development are outlined in the overall plan (3.4 point below). A cost and timeline estimation will be agreed later, once a better defined plan is available, and once a distribution of activities is agreed between at the JDC.
Pharmaceutical Development. (a) Subject to the terms of this Agreement, Cara shall be responsible for: (a) using Commercially Reasonable Efforts to conduct all non-clinical, clinical, CMC development and other studies that are required in order to obtain or maintain Regulatory Approvals of the Licensed Products in the United States in the Field of Use, reasonably in accordance with the development timeline in the Exhibit C established by Cara, and (b) providing Maruishi with all Information resulting from such development and all the Regulatory Documents submitted to FDA (and to other Regulatory Authority outside the Territory such as EMEA, if applicable), to the extent needed or useful in order to obtain Regulatory Approvals of Licensed Products in the CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [*]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
