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.
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. 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. (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. 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. At Buyer's sole cost and expense, Seller shall perform all additional testing, qualifications and validations of the Product that are reasonably required for Buyer's submission of its 510(k) clearance to the FDA. All existing testing, qualifications and validations in Seller's possession and based on the MedArt 426 platform will be made available at no charge to Buyer. The written protocols and reports of such testing shall be completed by Seller, with prior review by Buyer, and Seller and Buyer shall use their best efforts to complete such work according to the timeline listed on Schedule 2. Seller shall, at Seller's expense maintain the approval to apply the CE mark to the Product. In the event that device modifications xxxuested by Buyer result in approval expenses, the cost of such review and approval shall be the responsibility of the buyer. Other than as stated in the previous sentence, Buyer shall have responsibility for filing and obtaining all required consents, licenses, authorizations and approvals for the use and sale of the Product in such countries, including the United States, in which Buyer determines to sell the Product. All such consents, licenses, authorizations and approvals of the Product obtained by Buyer shall be held in the name of Buyer or its designee. Subject to the terms of Section 14 below governing confidentiality, Buyer shall have access to all test reports, manufacturing records and other documents of Seller that may be useful in obtaining or maintaining a registration for the Product in the United States and outside the United States and to facilitate the commercialization of the Product. Seller shall, at Buyer's sole cost and expense, provide continued regulatory assistance and support for the receipt and maintenance of the 510(k) clearance and CE mark as reasonably requested by Buyer. Buyer shall have the right to reference the source of its Product as supplied by Seller in its regulatory filings, product descriptions, sales literature and other descriptions of the Product.
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. 5.5
