Examples of Initial Regulatory Filing in a sentence
During such period, the Company shall keep ERS informed as to the status of such efforts, shall permit ERS to review and comment on the Initial Regulatory Filing during its preparation, and shall consult with ERS regarding the preparation of the Initial Regulatory Filing.
As used in this Section 4.8, a material delay is a delay arising from a requirement set forth by the FDA that the Company conduct additional clinical studies not conducted in connection with the submission of 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.
As used in this Section 4.7, a material delay is a delay arising from a requirement set forth by the FDA that DURECT conduct additional studies (clinical and non-clinical) not conducted in connection with the submission of the Initial Regulatory Filing.
Therefore, until the Initial Regulatory Filing is made (the "BLA Filing Date"), the Company shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing until the BLA Filing Date, and the Company shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.
Argyll Biotech shall keep Immunosyn informed as to the status of such efforts, shall permit Immunosyn to review and 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.
Therefore, until the Initial Regulatory Filing is made (the "NDA Filing Date"), DURECT shall be primarily responsible for conducting the 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 DURECT shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.
Therefore, until the Initial Regulatory Filing is made (the "BLA FILING DATE"), the Company shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing until the BLA Filing Date, and the Company shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.
From the Initial Regulatory Filing Transfer Date until the CDM Regulatory Filing Transfer Date (if it occurs), as between the parties, subject to the authority of the JPT with respect to Critical Matters and Joint Decision Matters, Company shall permit and reasonably support cross-referencing from Company-owned Regulatory Filings to Regulatory Filings in respect of investigator sponsored studies in respect the Product, to which studies Company has no reasonable objection.