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 (but not expiration of this Agreement), Zai will and hereby does, and will cause its Affiliates and Sublicensees to, (a) [****] assign and transfer to Blueprint or its designee all of Zai’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals for Licensed Products then owned or Controlled by Zai 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 Zai with respect to a Licensed Product. Zai 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, Zai will [****] 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 Zai 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 all Licensed Products no later than [****] after the effective date of termination of this Agreement.
Regulatory Submissions and Regulatory Approvals. To the extent requested by Licensor, Licensee 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 Licensor or its designee all of Licensee’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals then owned or Controlled by Licensee 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 and does hereby grant to Licensor
Regulatory Submissions and Regulatory Approvals. (a) Millennium or a Millennium Affiliate shall own all regulatory submissions, including all applications, for Regulatory Approvals in the United States and shall be solely responsible for seeking, and shall have the exclusive right to seek and obtain all Regulatory Approvals for the Product in the United States. OBI shall own all regulatory submissions, including all applications, for Regulatory Approvals in the License Territory and shall be solely responsible for seeking and obtaining, and shall have the exclusive right to seek and obtain, all Regulatory Approvals in the License Territory (subject to the provisions in this subsection (a) relating to the EU Application and EU Regulatory Approval Transfer). OBI shall use Diligent Efforts to seek Regulatory Approval for the Product in the License Territory, except with respect to the EU to the extent Millennium remains responsible for such Regulatory Approval process as provided in this Section 4.4(a). Promptly after the Effective Date, Millennium shall make all filings necessary to amend the application for Regulatory Approval in the EU (the "EU Application") in order to appoint OBI as Millennium's agent for Commercialization of the Product in the EU. Simultaneously with the making of such filings, Millennium shall (A) inform the EMEA product manager or other appropriate EMEA representative responsible for the EU Application that Millennium is making such filings and of Millennium's intention to transfer the Regulatory Approval in the EU to OBI (i.e., to change the market authorization holder to OBI) (the "EU Regulatory Approval Transfer") on or as soon as possible after such Regulatory Approval is obtained, and (B) seek the advice of such product manager or such other EMEA representative as to the most appropriate procedure to accomplish such EU Regulatory Approval Transfer to OBI on or as soon as possible after the Effective Date. Millennium shall use commercially reasonable efforts to follow such advice and shall take all actions reasonably necessary to accomplish the EU Regulatory Approval Transfer on or as soon as possible after the Effective Date. In the event that Regulatory Approval in the EU is not obtained by Millennium on or before [**] and OBI has not exercised its rights under Section 12.3(a)(ii), Millennium shall make all filings and take all actions reasonably necessary to transfer the EU Application to OBI as soon as possible after [**]. Each Party shall have access to all data contained o...
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) 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) 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.
Regulatory Submissions and Regulatory Approvals. To the extent requested by Licensor, Licensee will and hereby does, and will cause its Affiliates and Sublicensees to, except to the extent Sublicenses continue pursuant to Section 2.6.2 (Sublicense Survival), (a) no later than [***] days after the effective date of termination or expiration of this Agreement (or such longer period as may be required under Applicable Law), assign and transfer to Licensor or its designee all of Licensee’s rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals then owned or Controlled by Licensee or any of its
