Section # Regulatory Documentation and Regulatory Interactions 16

“Commercialization” means the marketing, promotion, distribution and sale of the Final Product(s) developed hereunder, any and all activities that relate to the marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of such Final Product (including pre-launch and marketing preparation activities) and any interactions with Regulatory Authorities after receipt of Regulatory Approval regarding the foregoing.

Responsibility. After the Effective Date, Allena shall be responsible for the Development and Commercialization of Product Candidates and Licensed Products, including responsibility for preparing, filing and maintaining all Regulatory Documentation and Regulatory Approvals that are required for the Development or Commercialization of Product Candidates and Licensed Products in the Field in the Territory and Allena shall otherwise be responsible for and have sole authority as to all interactions with Regulatory Authorities in the Territory with respect to the foregoing.

Unum has operational responsibility for preparing and filing all Regulatory Materials with respect to a Clinical Trial or other regulatory matter in the Shared Territory, and has primary operational responsibility for interactions with Regulatory Authorities in the Shared Territory, including taking the lead role at all meetings with Regulatory Authorities in the Shared Territory, subject to the right of SGI to participate in such activities and provide input (or consent, as may be required pursuant to the other terms of this Agreement). With respect to regulatory activities conducted in any country in support of Regulatory Approvals in the Shared Territory, the scope of this right of participation includes all regulatory activities, including development of regulatory strategy and advance review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Early Clinical Development Program or Late Clinical Development Program or registration package for a particular Development Candidate or Product, and review of outcomes of such meetings (including the rights set forth in [Section 7.1(c)(ii)]).

Prior to ​ proceeding with the In-Licensing, ​ shall provide ​ with prior notice, to the extent ​ has advance knowledge, of # any scheduled meeting, conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating to the Lead Compound (including interactions with Regulatory Authorities related to the pediatric plan), and # any inspection by any Regulatory Authority of ​ or any Third Party Provider of ​ (to the extent ​ is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of ​ to be present at such meeting, conference, discussion or inspection as a silent observer.

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.

Regulatory Event. The occurrence of a Level Two Regulatory Event which # remains unvacated, undischarged, unbounded or unstayed by appeal or otherwise for a period of 60 days from the date of its entry and # is reasonably likely to have a Material Adverse Effect; or