BioNTech Platform Product Clause Samples

BioNTech Platform Product. During the Term and to the extent permissible under relevant agreements concluded with Third Parties, BioNTech shall provide a high level safety report in connection with the development of BioNTech Platform Products in order for Genentech to determine whether such development could impact the Development of Collaboration Products and whether a Regulatory Authority may require the reporting of certain safety data and related Information for such applicable BioNTech Platform Products. The contents and frequency of such report shall be determined by the JDC. In the event that Genentech determines that it may need to inform or report certain safety data and related Information for one or more BioNTech Platform Products, the Parties, through the JDC, shall discuss in good faith a path for providing such safety data and related Information for such BioNTech Platform Products to a Regulatory Authority and BioNTech shall provide reasonable assistance to Genentech in order for Genentech to report such safety data and related Information. In the event that BioNTech may not disclose such safety data and related Information to Genentech under relevant agreements concluded with Third Parties, BioNTech shall use reasonable efforts to enable Genentech to comply with its obligations under Applicable Law (e.g., if requested by Genentech, through a direct communication with the Regulatory Authority requesting such safety data and related Information or by obtaining the consent from the relevant Third Party, if possible). Genentech shall provide to BioNTech copies of all correspondence submitted to or received from any Regulatory Authority to the extent related to such safety data or related Information provided to Genentech under this Section 5.9.