Regulatory Approval. Due to the nature of the Company’s business and Executive’s position with the Company, and, in addition to normal employment-related credit, reference and background investigations, Executive may also be required to complete applications required by various regulatory, tribal, state, local or other international governmental authorities in and under whose jurisdiction the Company and its affiliates conduct business, as well as other applications that may be required by regulatory authorities with jurisdiction over the Company and its affiliates. Such applications may require complete disclosure of personal and financial information, criminal convictions or arrests (expunged or not) and business associations. As an ongoing condition of Executive’s employment, Executive must be able to satisfy all applicable requirements of such governmental and regulatory authorities and obtain all necessary regulatory approvals and licenses.

The term “Regulatory Approval” shall mean any approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations by a Regulatory Authority, necessary for the manufacture and sale of a Product in the Field in a regulatory jurisdiction in the Territory.

“Regulatory Approval”. Regulatory Approval means an approval by the applicable Regulatory Authority of an NDA.

Regulatory Approval. Prior to the Effective Date, IND No. 116117 was filed for nanoliposome encapsulated BMEDA-chelated 186Rhenium. [[NanoTx:Organization]] shall cause the transfer of ownership of the IND for nanoliposome encapsulated BMEDA-chelated 186Rhenium, as set forth in Section 3.2, to PLUS. The Parties shall cooperate to ensure a smooth transition of such responsibilities and to assign or otherwise transfer the IND. Thereafter, PLUS shall be solely responsible for, in its sole discretion, but consistent with its application of Commercially Reasonable Efforts, the IND and applying for, at its cost and expense, all required Regulatory Approvals from the applicable Governmental Agency for nanoliposome encapsulated BMEDA-chelated 186Rhenium for rGBM and any other Licensed Product in the Field in the Territory. PLUS will own all Regulatory Approvals and all Regulatory Documentation for any Licensed Product in the Field in the Territory. For clarity, [[NanoTx:Organization]] (and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Licensed Product or otherwise communicate or interact with any Government Agencies with respect to the Licensed Products.

“Regulatory Approval”. Regulatory Approval means an approval by the applicable Regulatory Authority of an NDA.

Regulatory Approval. In the event that this Agreement is terminated by Verrica pursuant to [Section 13.2] or by Lytix pursuant to [Section 13.3 or 13.4]4], then, if at the time of termination of this Agreement, Verrica holds or has rights in or to any Regulatory Approvals for the Product in the terminated countr(ies) or Region, Verrica shall assign to Lytix or a Third Party designated by Lytix all such Regulatory Approvals for the Product, at Verrica’s cost and expense. In addition, upon Lytix’s written request, Licensee shall, at Verrica’s sole cost and expense, provide to Lytix copies of all tangible Development Data and Regulatory Filings Controlled by Verrica in the Territory necessary or useful for obtaining Regulatory Approval in the terminated countr(ies) or Region. Upon any such termination in such countr(ies) or Region, Verrica shall grant and does hereby grant to Lytix a transferrable Right of Reference to all Regulatory Filings pertaining to the Product submitted by or on behalf of Verrica anywhere in the Territory solely for the purpose of seeking, obtaining, and maintaining Regulatory Approval of CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY ​, HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED Product in such terminated countr(ies) or Region, including in interactions with any Regulatory Authority in connection with Development or Regulatory Approval of Product in such terminated countr(ies) or Region. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange.

Receipt of Regulatory Approval. Subject to [Section 6.7.3] (Effects of Opt-Out), upon receipt of Regulatory Approval in the U.S. (if any) for the Licensed Product in the new Indication or as part of a new Co-Administration Therapy, in each case, that was the subject of Additional Development Activities, the other Party will reimburse the proposing Party for # if the proposing Party is ITEOS, sixty percent (60%), and # if the proposing Party is GSK, forty percent (40%), in each case ((i) and (ii)), of the Out-of-Pocket Costs, Development FTE Costs and Manufacturing Costs incurred by the proposing Party in the performance of such Additional Development Activities for the U.S. and the European Union in accordance with the applicable Additional Development Proposal and the budget presented to the JDC in the Additional Development Proposal as set forth in [Section 3.4.1] (Additional Development Proposals) (provided that the costs incurred by the proposing Party that are subject to reimbursement under this [Section 3.4.3(c)] (Receipt of Regulatory Approval) shall be capped at ​ of such budget) plus an amount equal to ​ of the applicable amount set forth in the [foregoing clause (i) or (ii)])], as applicable, in consideration for the proposing Party taking the development risk for the new Indication or new Co-Administration Studies (for example, if GSK spent $100,000 on Additional Development Activities, and ITEOS was obligated to reimburse GSK for such Additional Development Activities pursuant to this 3.4.3(c) (Receipt of Regulatory Approval), then ITEOS would owe GSK $40,000 in reimbursement plus $40,000 in consideration of the development risk, for a total of $80,000). Following the date of Regulatory Approval for any new Indication or any Licensed Product as part of a new Co-Administration Therapy, the JDC will update the Global Development Plan and Global Development Budget to include any further or remaining Development of such approved new Indication, or Licensed Product as part of a new Co-Administration Therapy (as applicable) for the U.S. or European Union, and the JSC will approve such updates.

means, with respect to a particular country or other regulatory jurisdiction, all approvals, product or establishment licenses, registrations, or authorizations (including approval of a marketing authorization application) of all applicable regulatory authorities in such country or jurisdiction necessary for the commercial marketing or sale of a pharmaceutical product in such country or other regulatory jurisdiction for one (1) or more indications.

“Regulatory Approval”. Regulatory Approval means the granting by the FDA or by a comparable Regulatory Authority of approval to market a pharmaceutical preparation or product in a country in the Territory.

No Regulatory Approval. If such Regulatory Approval is not obtained, then the other Party will not be obligated to reimburse the proposing Party for the Out-of-Pocket Costs, Development FTE Costs or Manufacturing Costs incurred by the proposing Party in the performance of such Additional Development Activities.