Responsibility for Shared Products Sample Clauses

Responsibility for Shared Products. Following exercise of the SQZ Option for a given Shared Product or the Roche Antigen Option for a given Shared Product, the Party assigned responsibility for conducting the global Clinical Study shall be solely responsible for all regulatory affairs related to such Shared Product for use in the treatment of human diseases and conditions in the Territory, including the preparation and filing of INDs and applications for Regulatory Approvals. If Roche is responsible for conducting the global Clinical Study, then SQZ shall transfer all INDs with respect to the Shared Product to Roche at a time to be agreed after exercise of the SQZ Option or Roche Antigen Option, as applicable. The Party responsible for conducting the global Clinical Study shall be responsible for pursuing, compiling and submitting all regulatory filing documentation for, and for interacting with Regulatory Authorities with respect to such INDs and Regulatory Approvals in the SQZ Territory. Such Party shall consult with the other Party on such regulatory matters with regards to such Shared Products in the SQZ Territory and the other Party shall have observer rights in all interactions with Regulatory Authorities in countries where it has commercialization rights (i.e., SQZ in the SQZ Territory, and Roche in the Roche Territory), and in any case at least in the US, EU and China. Following Filing for a Shared Product, Roche shall have the right and responsibility for all regulatory affairs related to such Shared Product in the Roche Territory; and SQZ shall have the right and responsibility for all regulatory affairs related to such Shared Product in the SQZ Territory. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. 7.3.1 If Roche has conducted the global Clinical Study 7.3.2 If SQZ has conducted the global Clinical Study