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.
(b) Selecta will own all regulatory submissions, including all applications, for Regulatory Approvals for the Products in the Field in the Territory. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Selecta will be the primary contact with each Regulatory Authority in the Territory and will be solely responsible for all communications with each Regulatory Authority that relate to any Regulatory Filing or Regulatory Approval in the Territory, provided, however, that upon the reasonable request of Selecta, 3SBio will provide appropriate personnel to participate in discussions with a Regulatory Authority regarding the regulatory review process and will assist and consult with Selecta in applying for Regulatory Approval in the Territory in accordance with the terms of Section 3.2. In providing such assistance, 3SBio will not contact the Regulatory Authorities in the Territory without the prior written approval of Selecta, and, if contacted by a Regulatory Authority with respect to a Product in the Territory, will refer such contact to Selecta.
(d) From and after receipt of each Regulatory Approval in the Territory, Selecta will have exclusive authority and responsibility to submit all reports or amendments necessary to maintain such Regulatory Approvals and to seek revisions of the conditions of each such Regulatory Approval. Selecta will have sole authority and responsibility in the Territory to seek and/or obtain any necessary Regulatory Authority approvals of any product label, or Regulatory Authority-approved prescribing information, package inserts, monographs and packaging used in connection with Products, as well as promotional material used in connection with Products, and for determining whether the same requires Regulatory Approval.
Regulatory Submissions and Regulatory Approvals. Otsuka will and hereby does, and will cause its Affiliates and Sublicensees to, (a) no later than [***] after the effective date of termination of this Agreement in the Terminated Region(s), at Ionis’ request either (i) assign and transfer to Ionis or its designee all of Otsuka’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s) or (ii) solely with respect to any Terminated Region(s) in the Asia Territory, withdraw all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in such Terminated Region(s), in each case ((i) or (ii)), solely for the Licensed Products in the Terminated Region(s) then Controlled by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)), and (b) to the extent any assignment requested pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Ionis to cross-reference and rely upon any such Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)). Otsuka will execute and deliver, or will cause to be executed and delivered, to Ionis or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to effect the foregoing assignment, including submitting to each applicable Regulatory Authority or other Governmental Authority a letter or other necessary documentation (with copy to Ionis) notifying such Regulatory Authority or other Governmental Authority of, or otherwise giving effect to, the transfer of ownership to Ionis of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s). In addition, upon Xxxxx’ written request, Otsuka will, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), in which case Ionis shall [***]), provide to Ionis copies of all material related documentation, including material non-clinical, preclinical, and clinical data related to the Licensed Products in the Terminated Region(s) that are held by or reasonably available to Otsuka or its ...
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 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. (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.
(b) Defiante shall own all Regulatory Filings and Regulatory Approvals for Product in the Field for the Defiante Territory, and shall be responsible for the Regulatory Activities in Field in the Defiante Territory; provided that unless Dyax otherwise agrees in good faith, any Regulatory Filings for Product in the HAE Indication in the Defiante Territory shall be consistent (to the extent permitted by applicable law) with Regulatory Filings for Product in the HAE Indication in the United States. Dyax and its Related Parties shall have the right to access all data contained or referenced in such Regulatory Filings, including all reports, correspondence and conversation logs, and Defiante shall provide appropriate notification of Dyax's and its Related Parties' access and reference rights to the Regulatory Authorities. Defiante 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, to any and all data contained or referenced in any Regulatory Filing, including all reports, correspondence and conversation logs, and Defiante shall provide appropriate notification of Dyax's and its Related Parties' access and reference rights to the Regulatory Authorities.
(c) Dyax shall own all Regulatory Filings and Regulatory Approvals for Compound and for Product (i) inside the Field for the Dyax Territory and (ii) outside the Field, and shall be responsible for all Regulatory Activities in the Field in the Dyax Territory and outside the Field in any country of the world. Defiante and its and its Related Parties shall have the right to access all data contained or referenced in the Regulatory Filings (other than data arising out any Independent Development conducted by Dyax), including all reports, correspondence and conversation logs, and Dyax shall provide appropriate notification of Defiante's and its Related Parties access and reference rights to the Regulatory Authorities. Dyax hereby grants, and shall ensure that its Related Parties grant, to Defiante a "Right of Reference or Use," as that term is defined in 21 C.F.R. §314.3(b), and any foreign equivalents, to any and all data contained or referenced in any such Regulatory Filings relating to any Compound or Pro...
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
Regulatory Submissions and Regulatory Approvals. (a) Ownership of Regulatory Submissions.
(i) North America. NPS shall own all regulatory submissions, including all regulatory approval applications, for regulatory approvals in North America and shall be solely responsible for seeking and obtaining all regulatory approvals for Product in North America.
(ii) Territory. Nycomed shall own all regulatory submissions, including all Regulatory Approval Applications, for Regulatory Approvals in the Territory and shall be solely responsible for seeking and obtaining all Regulatory Approvals in the Territory.
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) 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. 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.
