“Regulatory Documentation” means all # applications (including all INDs, Drug Approval Applications and BLAs), registrations, licenses, authorizations and approvals (including Regulatory Approvals), # correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), and all supporting documents with respect thereto, including all adverse event files and complaint files, and # clinical and other data contained or relied upon in any of the foregoing; in each case of (a), (b) and (c) pertaining to a Licensed Product or an RTGel Component.

regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), including filings with the SEC or FDA, with respect to a Product as permitted hereunder;

Notices from Governmental Authorities. ​ has not received from any governmental authority written notice of # any violation of any Laws applicable (or alleged to be applicable) to the Real Property, or any part thereof, that has not been corrected, except as may be reflected by the Property Documents or otherwise disclosed in writing to ​, or # any pending or contemplated condemnation of the Real Property or any part thereof.

Filings with Governmental Authorities. Each EnTrust Entity has filed all material notices of any claim of exemption, registrations, reports, financial statements, sales literature, statements, notices and other material filings (including Forms ADV and Forms PF) relating to such EnTrust Entity or any EnTrust Fund required to be filed by it with any Governmental Authority (including filings with the Cayman Islands Monetary Authority and other foreign regulators), including all amendments or supplements to any of the above (the “EnTrust Filings”) for the past three (3) years. Such EnTrust Filings were timely filed, were accurate and complete, and complied in all material respects with the requirements of applicable Law.

Filings with Governmental Authorities. Each Permal Entity has filed all material notices of any claim of exemption, registrations, reports, financial statements, sales literature, statements, notices and other material filings (including Forms ADV and Forms PF) relating to such Permal Entity or any Permal Fund required to be filed by it with any Governmental Authority (including filings with the Cayman Islands Monetary Authority and other foreign regulators), including all amendments or supplements to any of the above (the “Permal Filings”) for the past three (3) years. Except as set forth on Section 5.12(f) of the Permal Disclosure Schedule, such Permal Filings were timely filed, were accurate and complete, and complied in all material respects with the requirements of applicable Law.

Authorization of Governmental Authorities. No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body, except such filing as may be necessary and/or required for disclosure by the Securities and Exchange Commission or pursuant to state securities or “blue sky” laws, is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Settlement Agreement.

Prior to [[Organization A:Organization]] proceeding with the In-Licensing, ​ shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the ​ products, if any, at periodic intervals to such Regulatory Authorities.

Electronic Communications. Notices and other communications to the Lenders and the L/C Issuer hereunder may be delivered or furnished by electronic communication (including e-mail and Internet or intranet websites) pursuant to procedures approved by the Administrative Agent, provided that the foregoing shall not apply to notices to any Lender or the L/C Issuer pursuant to [Article II] if such Lender or the L/C Issuer, as applicable, has notified the Administrative Agent that it is incapable of receiving notices under such Article by electronic communication. The Administrative Agent, the L/C Issuer, the Swing Line Lender or ​ may, in its discretion, agree to accept notices and other communications to it hereunder by electronic communications pursuant to procedures approved by it, provided that approval of such procedures may be limited to particular notices or communications.

Electronic Communications. Notices and other communications to the [[Organization C:Organization]] hereunder may be delivered or furnished by electronic communication (including e‑mail and Internet or intranet websites) pursuant to procedures approved by the [[Organization B:Organization]], provided that the foregoing shall not apply to notices to any Lender pursuant to Article II if such Lender has notified the [[Organization B:Organization]] that it is incapable of receiving notices under such Article by electronic communication. The [[Organization B:Organization]] or the [[Organization A:Organization]] may, in its discretion, agree to accept notices and other communications to it hereunder by electronic communications pursuant to procedures approved by it; provided that approval of such procedures may be limited to particular notices or communications.

Regulatory Proceedings. The Parties shall, and shall cause their Affiliates and each of their respective Representatives to, use reasonable best efforts to cooperate with each other in connection with the prompt withdrawal of any applications to, or termination of proceedings before, any Governmental Entity or under any applicable Law, in each case to the extent applicable and requested by a Party, in connection with the transactions contemplated by the SPA.