Regulatory Submissions and Regulatory Approvals. Partner will, and will cause its Affiliates and Sublicensees to, (a) no later than [*] after the effective date of termination of this Agreement, develop a plan for the assignment and transfer to uniQure or its designee all of Partner’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals and Reimbursement Approvals for the Existing Product then owned or Controlled by Partner or any of its Affiliates or Sublicensees, (b) complete assignment and transfer promptly in accordance with such plan, and (c) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit uniQure to cross-reference and rely upon any Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed by Partner with respect to such Existing Product. Partner will execute and deliver, or to cause to be executed and delivered, to uniQure or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to assign, 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 uniQure) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to uniQure of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals. In addition, upon uniQure’s written request, Partner will provide to uniQure copies of all material related documentation related to the Existing Product, including material non-clinical, preclinical, and clinical data related to the Existing Product that are held by or reasonably available to Partner or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, including with respect to any amendments to the SDE Agreement.
Regulatory Submissions and Regulatory Approvals. (a) Selecta will have sole authority and responsibility, at its sole cost and expense and in Selecta’s sole discretion, to seek and attempt to obtain all Regulatory Approvals for the Products in the Field in the Territory.
Regulatory Submissions and Regulatory Approvals. Partner will and hereby does, and will cause its Affiliates and Sublicensees to, (a) no later than [***] days after the effective date of termination of this Agreement (or such longer period as may be required under Applicable Law), assign and transfer to Kiniksa or its designee all of Partner’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals for the Licensed Product then owned or Controlled by Partner 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 Kiniksa to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Partner or any of its Affiliates or Sublicensees with respect to the Licensed Product. Partner will take all steps necessary to transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Kiniksa, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Kiniksa) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and 92 Regulatory Approval. In addition, upon Kiniksa’s written request, Partner will, at its cost and expense, provide to Kiniksa copies of all substantive related documentation, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Partner or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Kiniksa will assume all safety and safety database activities with respect to the Licensed Product no later than [***] days 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 with respect to a Terminated Product, CStone will and hereby does, and will cause its Affiliates and Sublicensees to, (a) [***], assign and transfer to Blueprint or its designee all of CStone’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals for such Terminated Product then owned or Controlled by 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 CStone with respect to such Terminated Product. 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, 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 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 any Terminated Product no later than [***] after the effective date of termination of this Agreement with respect to such Terminated Product.
Regulatory Submissions and Regulatory Approvals. (a) Overview. ORIC, directly and/or through its Affiliates and/or one or more Third Parties, shall have the sole right to seek and attempt to obtain all Regulatory Approvals for Licensed Products in the Field in the ORIC Territory and, as between the Parties, ORIC or its Affiliate shall own all Regulatory Filings, including all MXXx and Regulatory Approvals, for Licensed Products in the Field in the ORIC Territory. Voronoi or its Affiliate shall have the sole right to seek and attempt to obtain all Regulatory Approvals for Licensed Products in the Field in the Voronoi Territory and, as between the Parties, Voronoi or its Affiliate shall own all Regulatory Filings, including all MXXx and Regulatory Approvals, for Licensed Products in the Field in the Voronoi Territory. Each Party shall cooperate, at the other Party’s request, to facilitate discussions between such first Party’s personnel with knowledge of the Development of Licensed Products and the other Party, in order to assist the other Party in such other Party’s efforts to obtain one or more relevant Regulatory Approvals in such other Party’s Territory; provided, that, neither Party shall be required to incur any additional expenses, conduct any additional studies or modify its development efforts in order to provide such assistance.
Regulatory Submissions and Regulatory Approvals. (a) Regulatory Responsibilities. As between Licensor and Licensee, Licensee shall be solely responsible for obtaining all Regulatory Approvals for Products in the Field in the Territory at its sole cost, provided that if Licensor exercises the Reversion Option, Licensee will not be responsible for obtaining Regulatory Approvals for Products in the Field in those countries in the Option Territory for which Licensor exercised the Reversion Option.
Regulatory Submissions and Regulatory Approvals. (a) Each Party will have access to all Regulatory Filings by the other Party related to any Development activities conducted under any Joint Development Plan.
Regulatory Submissions and Regulatory Approvals. Sections 3.7.1, 3.7.3 and 3.7.4 of the Parent Agreement shall continue in full force and effect. Drafts of material submissions made by a Party to, or correspondence with, Regulatory Authorities in such Party’s territory regarding the Product will be provided to the other Party to the extent practicable a reasonable period prior to such submission. Portions of this exhibit, indicated by the xxxx “[***],” have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Regulatory Submissions and Regulatory Approvals. (a) Fovea shall own all regulatory submissions, including all applications, for Regulatory Approvals of the Product in the Field in the Fovea Territory, and shall be responsible for seeking and obtaining all Regulatory Approvals of the Product in the Field in the Fovea Territory as provided in the Core Development Plan. Dyax shall own all regulatory submissions, including all applications, for Regulatory Approvals of the Product in the Dyax Territory and shall, at Dyax’s sole discretion, be solely responsible for seeking and obtaining all Regulatory Approvals for the Product in the Dyax Territory. Each Party shall have access to all data contained or referenced in such submissions or applications for Regulatory Approvals of the Product, including without limitation all reports, correspondence and conversation logs, in each case as may be reasonably necessary to enable (i) Fovea to exercise its rights, and fulfill its obligations, under this Agreement to Develop, Manufacture and Commercialize the Product in the Field in the Fovea Territory and to perform its obligations under the Core Development Plan, and (ii) Dyax to Develop, Manufacture and Commercialize the Product outside the Fovea Territory and to exercise its retained rights with respect to all products containing the Compound. Each Party shall provide appropriate notification of such right of the other Party to the Regulatory Authorities.
Regulatory Submissions and Regulatory Approvals. (a) CMIC shall own, and may have its Affiliate own, all the Regulatory Filings and Regulatory Approvals for Product in Field in CMIC Territory, and shall be responsible for the Regulatory Activities for Product in Field in CMIC Territory; provided that, unless Dyax otherwise agrees in good faith, any Regulatory Filings for Product in the HAE Indication in CMIC Territory shall be consistent (to the extent permitted by the applicable law) with the Regulatory Filings for Product in the HAE Indication in the United States. If permitted under the Japanese laws, Dyax and its Related Parties shall have the right to access all the data contained or referenced in such Regulatory Filings, including all reports, correspondence and conversation logs (“Access and Reference Rights”), and CMIC shall provide appropriate notification of Dyax's and its Related Parties' Access and Reference Rights to the related Regulatory Authorities. Again, if permitted under the Japanese laws, CMIC hereby grants, and shall ensure that its Related Parties grant, to Dyax a "Right of Reference or Use," as that term is defined in 21 C.F.R. §314.3(b) as amended from time to time, and any foreign equivalents thereto, to any and all the data contained or referenced in any such Regulatory Filing, including all reports, correspondence and conversation logs, and CMIC shall provide appropriate notification of Dyax's and its Related Parties' Access and Reference Rights to the related Regulatory Authorities. Notwithstanding the foregoing, CMIC agrees that Dyax shall have the right to access all the data contained or referenced in such Regulatory Filings, through CMIC, to the same extent that CMIC or its Related Parties is granted such access.
