Technology Sharing. (a) Clearside shall provide to Arctic Vision electronic copies of the documents relating to Licensed Products set forth on Exhibit B(i) hereto within [***] of Clearside’s procurement or generation of such documents. (b) Clearside shall provide to Arctic Vision electronic copies of each of the documents set forth on Exhibit B(ii) hereto within [***] of Clearside’s procurement or generation of such documents. (c) To the extent not included in Exhibit B(ii), Clearside shall also provide to Arctic Vision all additional data and documents Controlled by the Clearside Entities and relating to Licensed Products that are [***] for Arctic Vision to file IND(s) in the Territory, including Know-How, regulatory data, clinical data, [***] which Arctic Vision did not and could not reasonably Certain information has been excluded from this agreement (indicated by “[***]”) because such information (i) is not material and (ii) would be competitively harmful if publicly disclosed. know of. Notwithstanding the foregoing, to the extent any data and documents are required by a Regulatory Authority in connection with Arctic Vision’s filing of IND(s) or Drug Approval Application(s) in the Territory, Clearside shall (i) provide to Arctic Vision all such data and documents Controlled by the Clearside Entities [***] existing as of the Effective Date for the Licensed Products, and (ii) use Commercially Reasonable Efforts to provide to Arctic Vision all such data and documents Controlled by (A) [***] and (B) [***]. (d) Throughout the Term, Clearside shall provide Arctic Vision with an update of any material regulatory developments (e.g., NDA filed, meetings with Regulatory Authority, or Regulatory Approval) relating to a Licensed Product made by Clearside, Clearside’s Affiliates or licensees, and upon Arctic Vision’s request, Clearside shall make available to Arctic Vision copies of Regulatory Documents, clinical and preclinical data, and efficacy, safety and pharmacovigilance data, in each case that are related to Licensed Product in the Field and Controlled by the Clearside Entities or any of their sublicensees (collectively, the “Clearside Product Data”), to the extent (i) such Clearside Product Data are [***] for any Arctic Vision Entity or their sublicensees to Develop, Manufacture or have Manufactured, or Commercialize Licensed Product in the Field in the Territory in accordance with this Agreement and are Controlled by the Clearside Entities, (ii) such Clearside Product Data are required by Regulatory Authority in the Territory in connection with the Development, Manufacturing, or Commercialization of Licensed Product in the Field in the Territory and are Controlled by the Clearside Entities or any of their Third Party sublicensees existing as of the Effective Date for the Licensed Products, and (iii) [***], such Clearside Product Data are required by Regulatory Authority in the Territory in connection with the Development, Manufacturing, or Commercialization of Licensed Product in the Field in the Territory and are Controlled by (A) [***] and (B) [***]; provided that (A) [***] and, [***], (B) [***], and (C) Clearside’s grant of access or rights to Arctic Vision to any Clearside Product Data that are also Controlled by any Clearside sublicensee of a product other than the Licensed Products shall be conditioned upon Arctic Vision’s payment of any amounts payable to such sublicensee in connection therewith. Clearside hereby grants to Arctic Vision and Arctic Vision’s Affiliates or sublicensees a right to access, use and reference the Clearside Product Data and Clearside Regulatory Documents in any Regulatory Filing made by Arctic Vision (or its Affiliates or sublicensees as the case may be) related to Licensed Product during the Term in the Territory. Other than the activities set forth in this Section 2.02 (Technology Sharing), Clearside will not perform any obligations set forth in this Agreement until [***] without Clearside’s written consent, not to be unreasonably withheld, conditioned or delayed. (e) Throughout the Term, upon Clearside’s request, Arctic Vision shall make available to Clearside copies of Arctic Vision Regulatory Documents, clinical and preclinical data, and efficacy, safety and pharmacovigilance data, in each case that pertain to Licensed Product and are Controlled by an Arctic Vision Entity or its sublicensee or sub-contractor (collectively, the “Arctic Vision Product Data”), to the extent such Arctic Vision Product Data are [***] for Clearside, its Affiliates or (sub)licensees to exercise its retained rights. Arctic Vision hereby grants to Clearside and Clearside’s Affiliates or sublicensees a right to access, use and reference the Arctic Vision Product Data and Arctic Vision Regulatory Documents in any Regulatory Filing made by Certain information has been excluded from this agreement (indicated by “[***]”) because such information (i) is not material and (ii) would be competitively harmful if publicly disclosed. Clearside ([***]) pertaining to Licensed Product in connection with the exercise of its retained rights; provided that such grant of right to any of Clearside’s sublicensees shall [***].
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Technology Sharing. (a) Clearside Sol-Gel shall provide to Arctic Vision electronic copies of the documents relating to Licensed Products set forth on Exhibit B(i) hereto within [***] of Clearside’s procurement or generation of such documents.
(b) Clearside shall provide to Arctic Vision electronic copies of each of the documents set forth on Exhibit B(ii) hereto within [***] of Clearside’s procurement or generation of such documents.
(c) To the extent not included in Exhibit B(ii), Clearside shall also provide to Arctic Vision SLP all additional data and documents Controlled by the Clearside Sol-Gel Entities and relating related to the Licensed Products Product that are [***] reasonably necessary for Arctic Vision SLP to file IND(s) Commercialize Licensed Product in the Territory, including Licensed Know-How, regulatory data, and clinical data, [***] which Arctic Vision did not and could not reasonably Certain information has been excluded from this agreement (indicated by “[***]”) because such information (i) is not material and (ii) would be competitively harmful if publicly disclosed. know of. Notwithstanding the foregoing, to the extent any data and documents are required by a Regulatory Authority in connection with Arctic Vision’s filing of IND(s) or Drug Approval Application(s) in the Territory, Clearside shall (i) provide to Arctic Vision all such data and documents Controlled by the Clearside Entities [***] existing as of the Effective Date for the Licensed Products, and (ii) use Commercially Reasonable Efforts to provide to Arctic Vision all such data and documents Controlled by (A) [***] and (B) [***].
(d) Throughout the Term, Clearside Sol-Gel shall provide Arctic Vision SLP with an update of any material regulatory developments (e.g., NDA or NDS filed, meetings with Regulatory Authority, or Regulatory Approval) relating to a Licensed Product made by ClearsideSol-Gel, Clearsideor Sol-Gel’s Affiliates or licensees, and upon Arctic VisionSLP’s request, Clearside Sol-Gel shall make available to Arctic Vision SLP copies of Regulatory Documents, clinical and preclinical data, and efficacy, safety and pharmacovigilance data, in each case that are related to Licensed Product in the Field and Controlled by the Clearside Sol-Gel Entities or any of their sublicensees licensees (collectively, the “Clearside Sol-Gel Product Data”), to the extent (i) such Clearside Sol-Gel Product Data are [***] reasonably necessary for any Arctic Vision SLP Entity or their sublicensees to Develop, Manufacture or have Manufactured, or Commercialize the Licensed Product in the Field in the Territory in accordance with this Agreement and are Controlled by the Clearside Sol-Gel Entities, (ii) such Clearside Sol-Gel Product Data are required by Regulatory Authority in the Territory in connection with the Development, Manufacturing, or Commercialization of Licensed Product in the Field in the Territory and are Controlled by the Clearside Entities Sol-Gel Entities, or any of their Third Party sublicensees existing as of the Effective Date for the Licensed Products, and (iii) [***]subject to Sol-Gel’s exercise of Commercially Reasonable Efforts to obtain, and Sol-Gel’s actual obtaining of, the prior written consent of any Sol-Gel Entities’ licensee, such Clearside Sol-Gel Product Data are required by Regulatory Authority in the Territory in connection with the Development, Manufacturing, or Commercialization of Licensed Product in the Field in the Territory and are Controlled by (A) [***] and (B) [***]; provided that (A) [***] and, [***], (B) [***], and (C) Clearside’s grant of access or rights to Arctic Vision to any Clearside Product Data that are also Controlled by any Clearside sublicensee of a product other than the Licensed Products shall be conditioned upon Arctic Vision’s payment of any amounts payable to such sublicensee in connection therewith. Clearside hereby grants to Arctic Vision and Arctic Vision’s Affiliates or sublicensees a right to access, use and reference the Clearside Product Data and Clearside Regulatory Documents in any Regulatory Filing made by Arctic Vision (or its Affiliates or sublicensees as the case may be) related to Licensed Product during the Term in the Territory. Other than the activities set forth in this Section 2.02 (Technology Sharing), Clearside will not perform any obligations set forth in this Agreement until [***] without Clearside’s written consent, not to be unreasonably withheld, conditioned or delayedThird Party licensee.
(eb) Throughout the Term, upon Clearside’s request, Arctic Vision SLP shall make available to Clearside Sol-Gel copies of Arctic Vision SLP Regulatory Documents, clinical and preclinical data, and efficacy, safety and pharmacovigilance data, in each case that pertain to Licensed Product and are Controlled by an Arctic Vision a SLP Entity or its sublicensee or sub-contractor (collectively, the “Arctic Vision SLP Product Data”), to the extent such Arctic Vision SLP Product Data are [***] reasonably necessary for ClearsideSol-Gel, its Affiliates or (sub)licensees to exercise its retained rights. Arctic Vision SLP hereby grants to Clearside Sol-Gel and ClearsideSol- Gel’s Affiliates or sublicensees licensees a right to access, use and reference the Arctic Vision SLP Product Data and Arctic Vision Regulatory Documents in any Regulatory Filing made by Certain information has been excluded from this agreement Sol-Gel (indicated by “[***]”) because such information or its Affiliates or (i) is not material and (ii) would be competitively harmful if publicly disclosed. Clearside ([***]sub)licensees as the case may be) pertaining to Licensed Product in connection with the exercise of its retained rights; provided that such grant . Without limiting the foregoing, SLP shall provide to the appropriate regulatory contacts as set out in the Safety Data Exchange Agreement, copies of right any annual or other periodic reports required to be submitted to any Regulatory Authority regarding the progress of Clearside’s sublicensees shall [***]any post-marketing requirements with respect to Regulatory Approval for the Licensed Product.
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