Common use of Regulatory Submissions and Regulatory Approvals Clause in Contracts

Regulatory Submissions and Regulatory Approvals. Otsuka will and hereby does, and will cause its Affiliates and Sublicensees to, (a) no later than [***] after the effective date of termination of this Agreement in the Terminated Region(s), at Ionis’ request either (i) assign and transfer to Ionis or its designee all of Otsuka’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s) or (ii) solely with respect to any Terminated Region(s) in the Asia Territory, withdraw all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in such Terminated Region(s), in each case ((i) or (ii)), solely for the Licensed Products in the Terminated Region(s) then Controlled by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)), and (b) to the extent any assignment requested pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Ionis to cross-reference and rely upon any such Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)). Otsuka will execute and deliver, or will cause to be executed and delivered, to Ionis or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to effect the foregoing assignment, including submitting to each applicable Regulatory Authority or other Governmental Authority a letter or other necessary documentation (with copy to Ionis) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to Ionis of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s). In addition, upon Xxxxx’ written request, Otsuka will, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), in which case Ionis shall [***]), provide to Ionis copies of all material related documentation, including material non-clinical, preclinical, and clinical data related to the Licensed Products in the Terminated Region(s) that are held by or reasonably available to Otsuka or its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)).

Regulatory Submissions and Regulatory Approvals. Otsuka will and hereby doesPartner will, and will cause its Affiliates and Sublicensees to, (a) no later than [***] after the effective date of termination of this Agreement in Agreement, develop a plan for the Terminated Region(s), at Ionis’ request either (i) assign assignment and transfer to Ionis uniQure or its designee all of OtsukaPartner’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals, Approvals and Reimbursement Approvals in the Terminated Region(s) or (ii) solely with respect to any Terminated Region(s) in the Asia Territory, withdraw all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in such Terminated Region(s), in each case ((i) or (ii)), solely for the Licensed Products in the Terminated Region(s) Existing Product then owned or Controlled by Otsuka Partner or any of its Affiliates or Sublicensees Sublicensees, (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses))b) complete assignment and transfer promptly in accordance with such plan, and (bc) to the extent any assignment requested pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Ionis uniQure to cross-reference and rely upon any such Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant Partner with respect to Section 14.9.5 (Sublicenses))such Existing Product. Otsuka Partner will execute and deliver, or will to cause to be executed and delivered, to Ionis uniQure or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to effect the foregoing assignmentassign, convey, transfer, and deliver to uniQure or its designee all of Partner’s or its applicable Affiliate’s or designee’s rights, title, and interests in and to all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals to uniQure, including submitting to each applicable Regulatory Authority or other Governmental Authority a letter or other necessary documentation (with copy to IonisuniQure) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to Ionis uniQure of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s)Approvals. In addition, upon Xxxxx’ uniQure’s written request, Otsuka will, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), in which case Ionis shall [***]), Partner will provide to Ionis uniQure copies of all material related documentationdocumentation related to the Existing Product, including material non-clinical, preclinical, and clinical data related to the Licensed Products in the Terminated Region(s) Existing Product that are held by or reasonably available to Otsuka Partner or its Affiliates or Sublicensees (for Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, including with respect to any Sublicensees that do not become a direct licensee of Ionis pursuant amendments to Section 14.9.5 (Sublicenses))the SDE Agreement.

Regulatory Submissions and Regulatory Approvals. Otsuka To the extent requested by Evelo following the date that a Party provides notice of termination of this Agreement, ALJ will and hereby does, and will cause its Affiliates and Sublicensees to, (a) no later than [***] after the effective date of termination of this Agreement with respect to any Terminated Product in the any Terminated Region(s)Country, at Ionis’ request either (i) assign and transfer to Ionis Evelo or its designee designee, all of OtsukaALJ’s rights, title, and interests in and to all Regulatory Submissions, Submissions and Regulatory Approvals, and Reimbursement Approvals in the for such Terminated Region(s) or (ii) solely with respect to any Terminated Region(s) in the Asia Territory, withdraw all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals Product in such Terminated Region(s), in each case ((i) Countries then owned or (ii)), solely for the Licensed Products in the Terminated Region(s) then Controlled by Otsuka ALJ or any of its Affiliates Affiliates, Sublicensees, or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses))Subcontractors, if any, and (b) to the extent any assignment requested pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Ionis Evelo to cross-reference and rely upon any such Regulatory Submissions, Submissions and Regulatory Approvals, and Reimbursement Approvals filed by Otsuka ALJ or any of its Affiliates Affiliates, Sublicensees, or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant Subcontractors with respect to Section 14.9.5 (Sublicenses))such Terminated Product. Otsuka ALJ will execute and delivertake, or will cause to be executed and deliveredits Affiliates, to Ionis or its designee such endorsements, assignments, commitments, acknowledgementsSublicensees, and other documents as may be Subcontractors to take, all steps necessary to effect the foregoing assignmenttransfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Evelo, including submitting to each applicable Regulatory Authority or other Governmental Authority a letter or other necessary documentation (with a copy to IonisEvelo) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, of the transfer of such ownership to Ionis of all such assigned each Regulatory Submissions, Submission and Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s)Approval. In addition, upon Xxxxx’ Evelo’s written request, Otsuka will, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), in which case Ionis shall [***]), ALJ will provide to Ionis Evelo copies of all material related documentationdocumentation relating to any Terminated Product in any Terminated Country, including material non-clinical, preclinical, and clinical data related to the Licensed Products in the Terminated Region(s) that are held by or reasonably available to Otsuka ALJ or its Affiliates Affiliates, Sublicensees, or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant Subcontractors. The Parties will discuss and establish appropriate arrangements with respect to Section 14.9.5 (Sublicenses))safety data exchange, if applicable.

Regulatory Submissions and Regulatory Approvals. Otsuka will and hereby does, and will cause its Affiliates and Sublicensees to, (a) no later than [***] after the effective date of termination of this Agreement in the Terminated Region(s)Agreement, at Ionis’ request either (i) assign and transfer to Ionis or its designee all of Otsuka’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s) or (ii) solely with respect to any Terminated Region(s) in the Asia Territory, withdraw all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in such Terminated Region(s), in each case ((i) or (ii)), solely for the Licensed Products in the Terminated Region(s) then Controlled by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)), and (b) to the extent any assignment requested pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Ionis to cross-reference and rely upon any such Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)). Otsuka will execute and deliver, or will cause to be executed and delivered, to Ionis or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to effect the foregoing assignment, including submitting to each applicable Regulatory Authority or other Governmental Authority a letter or other necessary documentation (with copy to Ionis) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to Ionis of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s)Approvals. In addition, upon XxxxxIonis’ written request, Otsuka will, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), in which case Ionis shall [***]), provide to Ionis copies of all material related documentation, including material non-clinical, preclinical, and clinical data related to the Licensed Products in the Terminated Region(s) that are held by or reasonably available to Otsuka or its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)).