Development and Regulatory Matters. 3.1 (a) The Parties acknowledge that Argyll Biotech currently intends in the future 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. 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. 22 4.1 Development Obligations 22 4.2 Development Reports 25 4.3 Regulatory Activities 25 4.4 Right of Reference and Use 27
Development and Regulatory Matters. As for Product A:
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. The parties acknowledge that Product manufactured under the Current Product Specifications uses HA sourced from avian tissue. The parties further acknowledge that, in some markets, the customer, regardless of regulatory requirements, prefers products using HA sourced from bacterial fermentation. In recognition of this fact, upon the Effective Date, Seller shall, at *** expense, use its *** efforts to begin qualifying a source of bacterial-fermented raw material that will meet the Current Product Specifications on Exhibit A1 and the regulatory requirements of those countries where Buyer, in its discretion, desires to sell bacterial fermented HA products. *** *** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED WITH ASTERISKS.
Development and Regulatory Matters. 3.1.1 Dermata shall, at its own expense, be solely responsible for conducting all development activities for the Licensed Products, including formulation optimization, manufacturing, packaging, non-clinical studies, and clinical trials, and for obtaining and maintaining all Regulatory Approvals and interactions with Regulatory Authorities for any Licensed Product in the Territory. Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the xxxx “[***]”.
