Regulatory Plan. Brii Bio shall develop, in its sole discretion, a regulatory plan for each Licensed Product that describes the regulatory actions to be taken by Brii Bio to obtain Marketing Approval in the Field in the Licensed Territory with respect to such Licensed Product. The regulatory plan, and all future updates and revisions to the regulatory plan, will be presented and discussed at the JSC, and Brii Bio shall consider any comments in good faith.
Appears in 1 contract
Sources: Collaboration and License Agreement (VBI Vaccines Inc/Bc)
Regulatory Plan. Brii Bio shall develop, in its sole discretion, a regulatory plan for each Licensed Product that describes the regulatory actions to be taken by Brii Bio to obtain Marketing Approval in the Field in the Licensed Territory with respect to such Licensed Product. The regulatory plan, and all future updates and revisions plan shall be submitted to the regulatory plan, will be presented Joint Steering Committee for review and discussed at the JSCcomment, and Brii Bio shall consider any such comments in good faith. Such regulatory plan shall be updated to reflect regulatory activities and changes agreed upon by the JSC at least once per year, until such time as the applicable Licensed Product receives Marketing Approval.
Appears in 1 contract
Sources: Collaboration and License Agreement (VBI Vaccines Inc/Bc)
Regulatory Plan. Brii Bio shall develop, in its sole discretion, a regulatory plan for each Licensed Product that describes the regulatory actions to be taken by Brii Bio to obtain Marketing Approval in the Field in the Licensed Territory with respect to such Licensed Product. The regulatory plan, and all future updates and revisions to the regulatory plan, will be presented and discussed at the JSC, and Brii Bio shall consider any comments in good faith.
Appears in 1 contract
Sources: Collaboration and License Agreement (VBI Vaccines Inc/Bc)