Common use of Development and Regulatory Matters Clause in Contracts

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. 3.1 (a) The Parties acknowledge that Argyll Biotech is currently intends in the process of preparing 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.