Development and Regulatory Matters. 3.1 (a) The Parties acknowledge that Argyll Biotech is in the process of preparing to submit an initial regulatory registration application for use of SF-1019 with respect to a Licensed Use with one or more regulatory bodies, such as the United States Food and Drug Administration or a foreign regulatory bodies (the “Initial Regulatory Filing”). Until the Initial Regulatory Filing is made and continuing indefinitely thereafter, Argyll Biotech shall be solely responsible for conducting clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing, and Argyll Biotech shall use all commercially reasonable efforts necessary to make such Initial Regulatory Filing. Argyll Biotech shall keep Immunosyn informed as to the status of such efforts, shall permit Immunosyn to review and privately to Argyll Biotech comment on the Initial Regulatory Filing and each subsequent regulatory filing during each filing’s preparation, and shall consult with Immunosyn regarding the preparation of the Initial Regulatory Filing and each subsequent filing.
Development and Regulatory Matters. A. Somaxon shall be solely responsible for conducting and paying for all clinical trials and for all regulatory filings/interactions, including pharmacovigilance related to the Licensed Product(s).
Development and Regulatory Matters. 23 4.1 Exchange of Data and Know-How.................................23 4.2 Product Registrations.........................................24 4.3 Scope of Clinical Development Plans and Clinical Budget.......24 4.4 Transition of Clinical Studies................................26 4.5 Conduct of Clinical Development Plans.........................26 4.6 Funding of Clinical Development Plans.........................27 4.7 IT Support....................................................28 4.8 Delay of Initial Regulatory Filing............................28 4.9 Suspension of Clinical Development Activities.................29 4.10 Liability.....................................................29 5.
Development and Regulatory Matters. 22 4.1 Exchange of Data and Know-How. 22
Development and Regulatory Matters. 23 4.1 EXCHANGE OF DATA AND KNOW-HOW...................................23 4.2 PRODUCT REGISTRATIONS...........................................24 4.3 SCOPE OF CLINICAL DEVELOPMENT PLANS AND CLINICAL BUDGET.........24 4.4 TRANSITION OF CLINICAL STUDIES..................................26 4.5 CONDUCT OF CLINICAL DEVELOPMENT PLANS...........................26 4.6 FUNDING OF CLINICAL DEVELOPMENT PLANS...........................27 4.7 IT SUPPORT......................................................28 4.8 DELAY OF INITIAL REGULATORY FILING..............................28 4.9 SUSPENSION OF CLINICAL DEVELOPMENT ACTIVITIES...................29 4.10 LIABILITY.......................................................29 5.
Development and Regulatory Matters. 4.1 Exchange of Data and Know-How.................................................................... 4.2
Development and Regulatory Matters. 3.1 Development in the Clinical Development Plan ASTELLAS shall remain responsible for and shall bear all Clinical Plan Development Costs in relation to completing, and shall perform in accordance with the terms of this Agreement and in particular, Sections 2.1(b), 2.1(f) and 3.5, all activities and all studies in each case as specified in the Clinical Development Plan and as detailed more specifically in Section 3.5 below subject to Sections 2.1(c) and 2.1(d).
Development and Regulatory Matters. 11 2.1 Development of the Licensed Product 11 2.2 Regulatory Matters in the Territory 13 2.3 Disclosures 14 ARTICLE III - MANUFACTURING AND SUPPLY 15 3.1 Manufacturing Development 15 3.2 Supply 15 ARTICLE IV - COMMERCIALIZATION 16
Development and Regulatory Matters. 3.1 Current Status of Development; Development Activities 54
Development and Regulatory Matters. As for Product A:
