Regulatory Materials; Data. Except if this Agreement is terminated by [[3D Medicines:Organization]] pursuant to Sections 13.4 or 13.5, [[3D Medicines:Organization]] shall # provide and assign to [[Aravive:Organization]] or its designee all Regulatory Materials, including Regulatory Approvals, for the Licensed Products to the extent possible under applicable Law in the [[3D Medicines:Organization]] Territory, # promptly provide to [[Aravive:Organization]] all Data (to the extent not already provided to [[Aravive:Organization]]), including pharmacovigilance data, generated by or on behalf of [[3D Medicines:Organization]], and # promptly return or destroy, at [[Aravive:Organization]]’s election, all Confidential Information of [[Aravive:Organization]].

Regulatory Materials; Data. Except in the event of # termination by Licensee for an uncured material breach by Ovid, or # termination by Licensee in the circumstances set forth in Section 14.2(b)(i) with respect to Ovid, or # Ovid’s termination for Safety Reason (where Licensee elects to continue the Development and Commercialization of the Product), within ​ after the effective date of such termination, Licensee shall transfer and assign to Ovid, at no cost to Ovid, all Regulatory Filings and Regulatory Approvals for the Products, Data from all pre-clinical, non-clinical, and clinical studies of the Product conducted by or on behalf of Licensee, its Affiliates, or Sublicensees, and all pharmacovigilance data (including all adverse event data) on the Products. In addition, at Ovid’s request, Licensee shall provide Ovid with reasonable assistance with any inquiries and correspondence with Regulatory Authorities regarding the Product in the Licensee Territory, such assistance shall be limited to a period of ​ after such termination.

Regulatory Materials; Data. Except in the event of # termination by Licensee for an uncured material breach by Ovid, or # termination by Licensee in the circumstances set forth in Section 14.2(b)(i) with respect to Ovid, or # Ovid’s termination for Safety Reason (where Licensee elects to continue the Development and Commercialization of the Product), within ​ after the effective date of such termination, Licensee shall transfer and assign to Ovid, at no cost to Ovid, all Regulatory Filings and Regulatory Approvals for the Products, Data from all pre-clinical, non-clinical, and clinical studies of the Product conducted by or on behalf of Licensee, its Affiliates, or Sublicensees, and all pharmacovigilance data (including all adverse event data) on the Products. In addition, at Ovid’s request, Licensee shall provide Ovid with reasonable assistance with any inquiries and correspondence with Regulatory Authorities regarding the Product in the Licensee Territory, such assistance shall be limited to a period of ​ after such termination.

Regulatory Materials; Data. Zai shall, and shall cause its Affiliates and Sublicensees to, ​, to the maximum extent permitted by Applicable Laws at the time of any such termination to promptly # assign all Regulatory Submissions and Regulatory Approvals and pricing and reimbursement approvals of Products to TPTX, and # assign all data generated by or on behalf of Zai or its designee while conducting Development or Commercialization activities under this Agreement to TPTX or its designee, including non-clinical and clinical studies conducted by or on behalf of Zai on Products and all pharmacovigilance data (including all Adverse Event database information) on Products.

Regulatory Materials; Data. To the extent permitted by Applicable Laws, Ono shall transfer and assign to [[Forty Seven:Organization]] all Regulatory Filings and Regulatory Approvals for the Products in any terminated country(ies) in the Ono Territory, and all Data from all preclinical, non-clinical, and clinical studies of Products conducted by or on behalf of Ono, its Affiliates, or Sublicensees, and all pharmacovigilance data (including all Adverse Event Data), free and clear of any liens or encumbrances; provided that, to the extent the foregoing assignment is not permitted by Applicable Laws, Ono hereby grants to [[Forty Seven:Organization]], effective as of the effective date of such termination, an exclusive (even as to Ono and its Affiliates) license, with the right to grant multiple tiers of sublicenses, under such Regulatory Filings, Regulatory Approvals and Data to research, Develop, Manufacture, have Manufactured, use, Commercialize, import, export and otherwise exploit any and all Licensed Antibodies and Products worldwide. If this Agreement is terminated by Ono pursuant to [Sections 14.3 or 14.4]4], such transfer, assignment or license shall be royalty-bearing in accordance with [Section 14.5.6]. If this Agreement is terminated other than by Ono pursuant to [Sections 14.3 or 14.4]4], the consideration for such transfer, assignment or license mentioned above shall be zero (0).

Regulatory Materials; Data. Within thirty (30) days of the effective date of such termination, Astellas shall transfer and assign to [[Cytokinetics:Organization]], at no cost to [[Cytokinetics:Organization]], all Regulatory Materials relating to any [ * ] Products, data from preclinical, non-clinical and clinical studies conducted by or on behalf of Astellas, its Affiliates or sublicensees relating to any [ * ] Products and all pharmacovigilance data (including all adverse event databases) relating to any[ * ] Products. At [[Cytokinetics:Organization]]’ request, Astellas shall provide [[Cytokinetics:Organization]] with assistance with any inquiries and correspondence with Regulatory Authorities relating to any [ * ] Product for a period of [ * ] months after such termination.

Regulatory Materials; Data. To the extent permitted by applicable Laws, [[Savara:Organization]] shall immediately transfer and assign to [[Grifols:Organization]] all Regulatory Materials (including all right, title and interest in all Regulatory Materials designed to obtain or support any Regulatory Approval, including all NDAs), data and Know-How relating to the Licensed Products and Compound and shall treat the foregoing as Confidential Information of [[Grifols:Organization]] (and not of [[Savara:Organization]]) under ARTICLE 11; provided that [[Savara:Organization]] shall be allowed to retain copies of any such materials that a Regulatory Authority requires [[Savara:Organization]] to retain under applicable Laws, or that [[Savara:Organization]] requires pursuant to its internal recordkeeping rules (with such information to be used strictly in accordance with such rules).

Regulatory Materials; Data. Apollomics shall # provide and assign to [[GlycoMimetics:Organization]] or its designee all Regulatory Materials, including Regulatory Approvals, for the Licensed Products to the extent possible under Applicable Law in the Apollomics Territory, # promptly provide and assign to [[GlycoMimetics:Organization]] all Data, including pharmacovigilance data, generated by or on behalf of Apollomics, and # promptly return or destroy (and certify such destruction in writing), at [[GlycoMimetics:Organization]]’ election, all Confidential Information of [[GlycoMimetics:Organization]].

Regulatory Materials. Ji Xing shall provide [[Cytokinetics:Organization]] with drafts in English of all Regulatory Materials in a reasonable time (in any event no less than ​ for Regulatory Materials other than an NDA or other application for Regulatory Approval, which shall be drafted and reviewed based on a schedule to be agreed by the Parties) prior to submission for review and comment, and shall consider in good faith any comments received from [[Cytokinetics:Organization]], which shall be provided within ​ of receipt. For clarity, ​. In addition, Ji Xing shall notify [[Cytokinetics:Organization]] of any Regulatory Materials submitted to or received from any Regulatory Authority in the Territory and shall provide [[Cytokinetics:Organization]] with copies thereof within ​ after submission or receipt, and shall notify [[Cytokinetics:Organization]] of any other material communication with any Regulatory Authority in the Territory within ​ after such communication. If any such Regulatory Material is not in the English language, Ji Xing shall also, ​ provide [[Cytokinetics:Organization]] with an English summary at the time of provision and a true, complete, accurate and certified English translation thereof as soon as practicable. If necessary, [[Cytokinetics:Organization]] shall assist Ji Xing in addressing any additional requirements requested by any Regulatory Authority in the Territory within a reasonable time (depending on the events), including providing existing supplementary data or documentation.

Regulatory Materials. For any Regulatory Materials and Regulatory Approvals for the Product that are held by Ji Xing or its Affiliate or sublicensees, Ji Xing shall (and shall cause its Affiliates and sublicensees to), as instructed by [[Cytokinetics:Organization]], either # if permitted by Applicable Laws, promptly transfer and assign all such Regulatory Materials and Regulatory Approvals to [[Cytokinetics:Organization]], # continue to hold any such Regulatory Materials and Regulatory Approvals for the sole benefit of [[Cytokinetics:Organization]] or its designee (in which case, Ji Xing shall appoint [[Cytokinetics:Organization]] or its designee as the exclusive distributor (with the right to subcontract and appoint subdistributors) under such Regulatory Materials and Regulatory Approvals for the Product in the Territory, and also as its agent to interact with the applicable Regulatory Authority in the Territory with respect to such Regulatory Materials and Regulatory Approvals), until such time [[Cytokinetics:Organization]] or its designee files its own Regulatory Materials and obtain its own Regulatory Approvals for the Product in the Territory; and/or # terminate or withdraw any such Regulatory Materials and Regulatory Approvals.