Regulatory Materials; Data. To the extent legally permissible, GSK shall transfer and assign to Liquidia, at no cost to Liquidia, all Regulatory Materials and Regulatory Approvals for the Liquidia Respiratory Product, as well as all data from non-clinical and clinical studies conducted by or on behalf of GSK, its Affiliates or sublicensees on the Liquidia Respiratory Product and all pharmacovigilance data (including all adverse event database) on the Liquidia Respiratory Product.
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 (1) assign all Regulatory Submissions and Regulatory Approvals and pricing and reimbursement approvals of Products to TPTX, and (2) 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. Solely in the event of execution of, and in such event within […***…] days of the effective date of, the definitive license agreement entered into between the Parties with respect an Option exercised by Xxxxxxx as contemplated by this Section 10.5: (i) Poseida shall transfer and assign to Xxxxxxx, as permitted by law, […***…] to Xxxxxxx, all regulatory materials uniquely specific to any Centyrin CAR Molecule(s) and/or Centyrin Therapeutic Molecule(s) that is the subject of such license, all data from preclinical, non-clinical and clinical studies conducted by or on behalf of Poseida, its Affiliates or Sublicensees specific thereto and all pharmacovigilance data (including all adverse event databases) specific to such Centyrin CAR Molecule(s) and/or Centyrin Therapeutic Molecule(s); and (ii) At Xxxxxxx’x request, Poseida shall provide Xxxxxxx with reasonable access to Poseida personnel and Poseida’s assistance with any inquiries and correspondence with Regulatory Authorities specific to the applicable such Centyrin CAR Molecule(s) and/or Centyrin Therapeutic Molecule(s), at a reasonable frequency, for a period of […***…] months thereafter.
Regulatory Materials; Data. To the extent permitted by applicable Laws, Alliqua shall transfer and assign to CCT all Regulatory Materials to extent such Regulatory Materials are not owned by CCT, and related data and Know-How relating to the Licensed Product(s) and shall treat the foregoing as Confidential Information of CCT (and not of Alliqua) under Article 11; provided that Alliqua shall be allowed to retain any such materials that a Regulatory Authority requires Alliqua to retain under applicable Laws.
Regulatory Materials; Data. As permitted by applicable Laws, Lumena shall transfer and hereby assigns to Sanofi all Regulatory Materials and Regulatory Approvals, worldwide, or in the terminated country(ies), as applicable.
Regulatory Materials; Data. Licensee shall, to the extent permitted by Applicable Laws, transfer and assign to Licensor any and all Regulatory Approval and other Regulatory Materials for the Products in the Field in the Territory. In addition, Licensee shall also provide Licensor with data and results generated from clinical trials and other studies of the Products and not previously provided to Licensor.
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.
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 (A) assign all Regulatory Submissions and Regulatory Approvals and pricing and reimbursement approvals of Licensed Product to Karuna, and (B) assign all data generated by or on behalf of Zai or its designee while conducting Development or Commercialization activities under this Agreement to Karuna or its designee, including non-clinical and clinical studies conducted by or on behalf of Zai on Licensed Product and all pharmacovigilance data (including all Adverse Event database information) on Licensed Product.
Regulatory Materials; Data. As permitted by applicable Laws, Mirum shall transfer and hereby assigns to Shire all Regulatory Materials and Regulatory Approvals for the terminated Licensed Product(s) (solely to the extent owned or Controlled by Mirum or its Affiliates as of the effective date of such termination), worldwide, or in the terminated country(ies), as applicable. To the extent such assignment is not permitted by applicable Law, Mirum hereby grants to Shire a license and right of reference under such Regulatory Materials and Regulatory Approvals.
Regulatory Materials; Data. Within thirty (30) days of the effective date of such termination (or as promptly as practical thereafter, if such period is not practical under Applicable Law), Sanofi shall transfer and assign to MyoKardia all Regulatory Materials and Regulatory Approvals relating to Products, data from preclinical, non-clinical and clinical studies conducted by or on behalf of Sanofi, its Affiliates or (Sub)licensees on any Products and all pharmacovigilance data (including all adverse event databases) on any Products. In addition, subject to any applicable provisions of any Third Party contract manufacturing agreement, Sanofi shall, or cause its Affiliate or Third Party contract manufacturer to, grant MyoKardia and any of its Affiliates and Third Party contract manufacturer the right to reference any and all drug master files pertaining to Products. At MyoKardia’s request, Sanofi shall provide MyoKardia with assistance with any inquiries and correspondence with Regulatory Authorities relating to any Product for a period of six (6) months after such termination. Sanofi’s activities under this Section 12.3(d) shall be conducted at no cost to MyoKardia in the case of a termination by MyoKardia pursuant to Section 12.2(b) or otherwise at MyoKardia’s cost. The foregoing shall not apply to the extent containing proprietary information or technology of any Third Party relating to proprietary active ingredients contained in Combination Products that are DCM1 Products or not within the scope of the licenses granted to MyoKardia hereunder.
