Regulatory Submissions and Approvals. Bayer shall be solely responsible for filing for and shall own all Regulatory Approvals and submissions therefor. To the extent permitted by applicable Laws, Bayer shall permit Dimension to attend in an observatory capacity only all meetings with Regulatory Authorities in the U.S., to the extent related to a Licensed GT Product, including, but not limited to, all in-person meetings and all telephone conferences.
Regulatory Submissions and Approvals. Upon Asana’s written request, Company shall provide Asana with copies of all Regulatory Submissions made with respect to the Licensed Products by Company, its Affiliates or sublicensees, and assign to Asana (and shall provide Asana with a right of reference with respect to) such Regulatory Submissions and resulting Regulatory Approvals, at Company’s cost and expense. In addition, upon Asana’s written request, Company shall, at its cost and expense, provide to Asana copies of all material related documentation, including material non-clinical, preclinical and clinical data with respect to the Licensed Product that are held by or reasonably available to Company, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange for the Licensed Products; provided that Asana will assume all safety and safety database activities for the Licensed Products no later than six (6) months after termination.
Regulatory Submissions and Approvals. (a) Product A.
(i) Subject to Section 3.1 and consistent with Sections 4.1(a) and 4.1(b), for Product A, Acura shall be responsible for pursuing, compiling and submitting all regulatory documents, and shall lead the interactions with the FDA through Regulatory Approval of the NDA for Product A, and King shall be responsible for and shall reimburse Acura for any and all out-of-pocket costs incurred by Acura in submitting, filing and obtaining the NDA for Product A with the FDA, including any amounts paid by Acura under the Prescription Drug User Fee Act, in each case as provided for under Section 8.
(ii) After Regulatory Approval of the NDA for Product A by the FDA, King shall be responsible for compiling and submitting all regulatory documentation and for interacting with the FDA for Product A. Acura agrees to cooperate with King with respect to the regulatory activities King undertakes pursuant to this Section 5.1(a)(ii). Following Regulatory Approval of the NDA for Product A by the FDA, King shall own and maintain, at its sole cost, all regulatory filings and Regulatory Approvals for Product A. Xxxx shall provide Acura with complete copies of all applications, submissions, filings and material regulatory correspondence related to Product A in the Territory.
(iii) King, at its sole cost, shall pursue all Regulatory Approvals related to Product A in Mexico and Canada, including the preparation and filing of applications for clinical trials and Regulatory Approvals. King shall own and maintain, at its sole cost, all regulatory filings and Regulatory Approvals for Product A in Mexico and Canada. King shall promptly provide Acura with complete copies of all such applications, submissions, filings and regulatory correspondence related to Product A in Mexico and Canada.
(b) Product B.
(i) For Product B, for the period beginning on the Effective Date and ending on the date the Product B IND becomes effective pursuant to 21 C.F.R. §312.40(b), Acura and/or its designated Third Parties will be responsible, in consultation with King, for the performance of all regulatory activities required for the Product B IND to become effective. For purposes of clarity, before the Product B IND becomes effective, Acura shall be responsible for compiling and submitting all regulatory documentation and for interacting with the FDA for Product B. Acura shall consult with King and shall consider in good faith any suggestions King may have with respect to such regulatory activities. ...
Regulatory Submissions and Approvals. Licensee, at its sole cost, shall pursue all Regulatory Approvals related to the Products in the Territory, including the preparation and filing of applications for clinical trials and Regulatory Approvals. Licensee shall own and maintain, at its sole cost, all regulatory filings and Regulatory Approvals for the Products in the Territory. Licensee shall promptly provide Advaxis with complete copies of all such applications, submissions, filings and regulatory correspondence related to the Products in the Territory. In the event that Licensee wishes to discontinue the pursuit or maintenance of a Regulatory Approval in any part of the Territory, Advaxis shall have the right to step in and assume the pursuit or maintenance of such Regulatory Approvals at its sole cost and Licensee shall transfer ownership of such Regulatory Approval and all documents related thereto to Advaxis, provided that Advaxis shall reimburse Licensee for all reasonable costs and expenses incurred by Licensee to pursue or maintain the Regulatory Approval.
Regulatory Submissions and Approvals. Each Party will be responsible for submitting all Regulatory Submissions (including all pre-submissions and applications for Regulatory Approval) to the Regulatory Authorities, all communications with Regulatory Authorities, and the maintenance of all Regulatory Approvals, in each case, relating to Development, manufacturing, use, or commercialization of the IVD Kits, in their respective territories (i.e., in the Territory for Oncocyte and outside the Territory for Bio-Rad). Upon either Party’s written request, the other Party will provide the requesting Party with access to all draft Regulatory Submissions relating to the IVD Kits, and the requesting Party will provide comments, if any, back to the other Party within [***] days for each document. Each Party will consider in good faith any comments from the other Party regarding such draft Regulatory Submission and the final Regulatory Submissions relating to the IVD Kits. Each Party will use Commercially Reasonable Efforts to protect trade secret information that may be contained in Regulatory Approvals with respect to the IVD Kits.
Regulatory Submissions and Approvals. Upon Marinus’ written request to the extent delivered on or before the effective date of termination or within thirty (30) days thereafter and to the extent permissible under Applicable Law, Licensee shall provide Marinus with copies of all Regulatory Submissions, Regulatory Approvals and pricing and reimbursement approvals for Licensed Products in the Territory. To the extent permissible under Applicable Law, Licensee shall assign to Marinus or shall provide Marinus with a right of reference with respect to such Regulatory Submissions, Regulatory Approvals and pricing and reimbursement approvals, in each case, as the Parties determine in good faith, at Marinus cost and expense. In addition, upon Marinus’ written request, Licensee shall, at Marinus’ cost and expense, provide to Marinus copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably and readily available to Licensee or its Affiliates. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange.
Regulatory Submissions and Approvals. Daré shall be responsible for filing for and shall own (or its designees shall own) all Marketing Approvals and any other regulatory approvals relating to the Commercialization of the Product in the Territory. Daré shall provide to Bayer a copy of all written substantive communications from and with any Regulatory Authority involving a regulatory submission for the Product or any other component thereof sufficiently in advance, where feasible, to enable Bayer to have a meaningful opportunity to provide input on the content of such submission and, if reasonably requested by Bayer, to participate in scientific advice meetings with the Regulatory Authority related to the Product. At Bayer’s request Daré shall provide Bayer with access to the Regulatory Documentation.
Regulatory Submissions and Approvals. (a) Regulatory Responsibilities. BioNTech will be responsible for all regulatory activities relating to the Licensed Products, including preparing and filing all XXXx and seeking all Regulatory Approvals for the Licensed Products in the Field in the Territory in accordance with the CDP or BioNTech Development Plan, as applicable, except for any regulatory activities that are expressly delegated or transferred to OncoC4 in the CDP, as approved by the JSC, or as expressly set forth in this Agreement.
Regulatory Submissions and Approvals. Upon RemeGen’s written request, Seagen shall provide RemeGen with copies of all material Regulatory Submissions made with respect to an Opt-In Terminated Product, in each case Controlled by Seagen and not already provided to RemeGen, and assign to RemeGen (or if such assignment cannot be achieved, shall provide RemeGen with a right of reference with respect to) all such material Regulatory Submissions and resulting Regulatory Approvals relating solely to such Opt-In Terminated Product in the applicable Opt-In Product Termination Territory, [ * ]. In addition, upon RemeGen’s written request, Seagen shall, [ * ], provide to RemeGen copies of all clinical data with respect to [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. an Opt-In Terminated Product that is held by or reasonably available to Seagen, its Affiliates or sublicensees, to the extent not already in RemeGen’s possession. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange for an Opt-In Terminated Product as applicable; provided that RemeGen will assume all safety and safety database activities for each Opt-In Terminated Product in the applicable Opt-In Product Termination Territory, in each case no later than [ * ] after termination.
Regulatory Submissions and Approvals. Daré shall be solely responsible for filing for and shall own (or its designees shall own) all IDEs and PMAs, and any other regulatory approvals relating to the Development of Product.
