After [[Organization A:Organization]] proceeds with the In-Licensing, [[Organization A:Organization]] shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). ​ shall support [[Organization A:Organization]], as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, ​ shall retain the right to prepare, obtain, and maintain all regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities) solely for ​ to perform the Development activities undertaken pursuant to Sections 3.1.2, 3.1.4 and 3.1.7.

Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA and other regulatory authorities in the Field in the Territory with respect to Licensed Product.

Commencing upon the assignment of an IND by ​ to [[Organization A:Organization]] pursuant to [Section 3.7.1(ii)], [[Organization A:Organization]] shall have the sole right and responsibility to maintain in its name such IND, and to conduct communications with the applicable Regulatory Authorities with respect to such IND. Without limiting the foregoing, [[Organization A:Organization]] shall have the sole right and responsibility to prepare, obtain and maintain in its name all other INDs necessary to perform its obligations under the Development Plan, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs. Notwithstanding the foregoing, ​ shall have the right and responsibility to maintain in its name an IND and to conduct communications with the applicable Regulatory Authorities with respect to such IND solely for ​ to perform the Development activities undertaken pursuant to Sections. 3.1.2, 3.1.4 and 3.1.7.

Responsibility. Subject and pursuant to the terms of this Agreement, Allergan shall have the sole right and responsibility, at its sole expense, to Develop the Licensed Products and, without limiting the generality of the foregoing, to # file all Drug Approval Applications or BLAs and make all other filings with the Regulatory Authorities, and to otherwise seek all Regulatory Approvals for Licensed Products, in the Territory, as well as to conduct all correspondence and communications with Regulatory Authorities regarding such matters and # report all adverse events to Regulatory Authorities if and to the extent required by Applicable Law.

Communications. All Participant or Beneficiary notices, designations, elections, consents or waivers must be made in a form the Administrator (or, as applicable, the Trustee or Insurer) specifies or otherwise approves. Any person entitled to notice under the Plan may waive the notice or shorten the notice period unless such actions are contrary to applicable law.

Communications. Except to the extent required by Applicable Law as required under Section 11.2, WuXi ATU shall not communicate with any regulatory or government authorities, including but not limited to the FDA, on Graphite’s behalf without Graphite’s prior written authorization.

Communications. WuXi ATU shall keep Graphite reasonably informed about the status of the Services. WuXi ATU agrees to participate in activities including meetings and/or conference calls that may be held on a regular basis between the Project Managers and other WuXi ATU and Graphite personnel to evaluate, review or discuss the progress made on the performance of the Services.

Adverse Experiences. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, ​ shall have responsibility (either itself or with the support of Third Party subcontractors) for communications with all Regulatory Authorities regarding the safety of the Lead Compound, including submitting or causing to be submitted to all Regulatory Authorities reports of adverse experiences and other required safety information and reports in accordance with all requirements of Applicable Laws. ​ shall provide a copy of any and all such reports and other required safety information to [[Organization A:Organization]] within […​…] after regulatory submission.

“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.

Section # Waiver; Amendments.

Electronic Communications. Notices and other communications to the ​ and the L/C Issuers hereunder may be delivered or furnished by electronic communication (including e-mail, FpML messaging 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 any L/C Issuer pursuant to Article II if such Lender or such 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 Swing Line Lender, any L/C Issuer and each Borrower 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.

Privileged Communications. It is expected that, in furtherance of this Agreement, the parties will, from time to time, disclose to one another privileged communications with counsel, including opinions, memoranda, letters and other written, electronic and verbal communications. Such disclosures are made with the understanding that they shall remain confidential and that they are made in connection with the shared community of legal interests existing between the parties, including the community of legal interests in avoiding infringement of any valid, enforceable third-party patents and in obtaining patent protection for Developed Intellectual Property.