Proposed Additional Indication Sample Clauses

Proposed Additional Indication. BioNTech may, at any time during the Term, based upon sound scientific rationale, provide the JDC with a written proposal meeting the requirements of this Section 4.5.1 (“Study Proposal”) to amend the GDP to include a Clinical Study (“Proposed Study”) for Development of a Collaboration Product in an Indication that is not then included in the GDP. Each such Study Proposal shall include [***]. BioNTech shall present such Study Proposal to the JDC at its next regularly scheduled meeting. The JDC shall decide whether to approve such Proposed Study and whether to add the relevant Indication to the GDP, which decision shall be reflected in the minutes of the JDC. Each Study Proposal shall contain reasonably sufficient detail to enable the JDC to assess whether to approve such Proposed Study and whether to add the relevant Indication to the GDP. If the JDC decides to add the Indication covered by the Study Proposal to the GDP, the GDP shall be amended to include the Proposed Study (together with any modifications agreed upon by the JDC), such Indication shall become a GDP Indication, and the Conduct of such Proposed Study (as modified by the JDC) and any additional Clinical Studies in such Indication shall be a Joint Development Activity, pursuant to Section 4.4. In the event that the JDC declines to add a new Indication presented by BioNTech to the GDP pursuant to this Section 4.5.1, then BioNTech may have the right to Conduct the Proposed Study to the extent permitted pursuant to Section 4.5.2 as a “BioNTech Study”, and upon Initiation by BioNTech of the Proposed Study and subject to Section 4.5.5(c), such Indication, shall be a “BioNTech Indication” and such Collaboration Product shall be a “BioNTech Collaboration Product”.