Common use of Regulatory Submissions and Regulatory Approvals Clause in Contracts

Regulatory Submissions and Regulatory Approvals. To the extent requested by Blueprint following the date that a Party provides notice of termination of this Agreement (but not expiration of this Agreement), Zai will and hereby does, and will cause its Affiliates and Sublicensees to, (a) [****] assign and transfer to Blueprint or its designee all of Zai’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals for Licensed Products then owned or Controlled by Zai or any of its Affiliates or Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Blueprint to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Zai with respect to a Licensed Product. Zai will take all steps necessary to transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Blueprint, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Blueprint) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and Regulatory Approval. In addition, upon Blueprint’s written request, Zai will [****] provide to Blueprint copies of all material related documentation, including material non-clinical, preclinical, and clinical data that are held by or reasonably available to Zai or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Blueprint will assume all safety and safety database activities with respect to all Licensed Products no later than [****] after the effective date of termination of this Agreement.

Regulatory Submissions and Regulatory Approvals. To the extent requested by Blueprint following the date that a Party provides notice of termination of this Agreement (but not expiration of this Agreement)with respect to a Terminated Product, Zai CStone will and hereby does, and will cause its Affiliates and Sublicensees to, (a) [****] ], assign and transfer to Blueprint or its designee all of ZaiCStone’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals for Licensed Products such Terminated Product then owned or Controlled by Zai CStone or any of its Affiliates or Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Blueprint to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Zai CStone with respect to a Licensed such Terminated Product. Zai CStone will take all steps necessary to transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Blueprint, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Blueprint) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and Regulatory Approval. In addition, upon Blueprint’s written request, Zai CStone will, at its cost and expense (unless this Agreement is terminated by CStone pursuant to Section 15.2.2 (Termination for Material Breach) or Section 15.2.5 (Termination for Insolvency), in which case Blueprint will [****] bear all such costs and expenses), provide to Blueprint copies of all material related documentation, including material non-clinical, preclinical, and clinical data that are held by or reasonably available to Zai CStone or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Blueprint will assume all safety and safety database activities with respect to all Licensed Products any Terminated Product no later than [****] after the effective date of termination of this AgreementAgreement with respect to such Terminated Product.