Regulatory Materials; Data. Within [ * ] of the effective date of termination of this Agreement, Collaborator shall transfer and assign to Exelixis, at no cost to Exelixis, all Regulatory Filings and Regulatory Approvals for the Products, Data from all preclinical, non-clinical and clinical studies conducted by or on behalf of Collaborator, its Affiliates, or Sublicensees on the Products, and all pharmacovigilance data (including any adverse events database) on the Products. In the event any Regulatory Filings and/or Regulatory Approval for a Product cannot be transferred to Exelixis within such [ * ] period, Collaborator shall continue to maintain such Regulatory Fillings and/or Regulatory Approval until such time as Collaborator is permitted to transfer such Regulatory Filing or Regulatory Approval to Exelixis. In addition, at Exelixis’ request, Collaborator shall provide Exelixis with reasonable assistance with any inquiries and correspondence with Regulatory Filings and Regulatory Authorities regarding the Product in the Collaborator Territory for a period of [ * ] after such termination. Exelixis shall be responsible for Collaborator’s reasonable costs incurred directly in connection with any such Exelixis request.
Appears in 3 contracts
Sources: Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.)