Common use of Notice of Regulatory Action Clause in Contracts

Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Zai relating to any Licensed Product, then Zai shall notify NVCR of such contact, inspection or notice or action within [***] hours thereof. NVCR shall have the right to review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product, provided that Zai shall have the final decision-making authority with respect to such responses to the extent relating solely to such Licensed Product in the Field and in Territory and such responses would not have any negative impact on the research, Development, manufacturing or Commercialization of any Licensed Product outside the Territory, but shall incorporate all such reasonable comments of NVCR during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory. The costs and expenses of any regulatory action in the Territory shall be borne solely by [***].