Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. Upon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or shall provide NVCR with a right of reference with respect to such Regulatory Submissions, as NVCR determines at its reasonable discretion, at [***] cost and expense. In addition, upon NVCR’s written request, Zai shall, at [***] cost and expense, provide to NVCR copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably available to Zai, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that NVCR will assume all safety and safety database activities no later than [***] months after termination.

Regulatory Submissions. Upon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or 44 shall provide NVCR with a right of reference with respect to such Regulatory Submissions, as NVCR determines at its reasonable discretion, at [***] cost and expense. In addition, upon NVCR’s written request, Zai shall, at [***] cost and expense, provide to NVCR copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably available to Zai, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that NVCR will assume all safety and safety database activities no later than [***] months after termination.