Assignee shall use commercially reasonable efforts and due diligence, itself and/or through one or more Licensees, to develop, and to obtain regulatory approval to market, at least one Product, as promptly as is reasonably and commercially feasible.

Annual Reports; Etc. Promptly after the same are required to be delivered or may be available, as the context requires, copies of each annual report, proxy or financial statement or other report or communication sent to the stockholders of the ​, and copies of all annual, regular, periodic and special reports and registration statements which the ​ may file or be required to file with the SEC under Section 13 or 15(d) of the Securities Exchange Act of 1934, or with any national securities exchange, and in any case not otherwise required to be delivered to the [[Administrative Agent:Organization]] pursuant hereto.

Reporting. Spero shall provide to Northern a written report for each calendar quarter, which shall adequately describe the status of the development and commercialization of the Licensed Compounds and Licensed Products (including for the avoidance of doubt any Combination Product), including at a minimum: results and data of any clinical or non-clinical studies and ​. All such reports and their contents shall constitute Confidential Information of Spero.

No later than ​ prior to the projected NDA filing date for a Product in the Shared Territory, the JCC will prepare and recommend to the JSC for approval an initial Joint Commercialization Plan for each Product (including the initial Joint Commercialization Budget). Subject to Section 8.3(c), each Joint Commercialization Plan will allocate the Co-Promotion responsibilities of the Parties in an equitable fashion taking into account the Parties’ respective capabilities. For clarity, SGI will be responsible for all Commercialization activities in the Licensed Territory, and such activities will not be included in the Joint Commercialization Plan. All Joint Commercialization Plans, including the corresponding Joint Commercialization Budgets, with respect to each Product in the Shared Territory and subsequent revisions thereto will contain such information as the JCC believes necessary for the successful Commercialization of such Product in the Shared Territory, both pre- and post-launch, and will generally conform to the level of detail utilized by the Lead Commercializing Party in preparation of its own product Commercialization plans. On an annual basis, or more often as the Parties deem appropriate, the JCC will prepare amendments to the then-current Joint Commercialization Plan(s), including the corresponding Joint Commercialization Budgets. In the event of any inconsistency between a Joint Commercialization Plan and this Agreement, the terms of this Agreement will prevail. Each Party will conduct its activities under the Joint Commercialization Plan(s) in compliance in all material respects with Applicable Law.

“Segregate” means, with respect to an Alternative Product, to use diligent efforts to segregate the research, development, manufacture and commercialization activities relating to such Alternative Product from Research, Development, Manufacture and Commercialization with respect to any Research Candidates, Development Candidates or Products under this Agreement, including using diligent efforts to ensure that: # no personnel involved in performing the research, development, manufacture or commercialization of such Alternative Product have ​ relating to the Research, Development, Manufacture or Commercialization of any Research Candidates, Development Candidates or Products (provided that ​ may ​ regarding the Research, Development, Manufacture and Commercialization of any Research Candidates, Development Candidates or Products in connection with ​); and # no personnel involved in performing the Research, Development, Manufacture or Commercialization of any Research Candidates, Development Candidates or Products have access to ​ relating to the research, development, manufacture or commercialization of such Alternative Product (provided that ​ may ​ regarding the research, development, manufacture and commercialization of such Alternative Product in connection with ​).

“Commercialization” […​…]. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning.

Record Keeping and Reports. Zai Lab will prepare and maintain, and will cause each of its Affiliates and any licensees or sublicensees to prepare and maintain, appropriate records (in accordance with its standard policies and procedures) regarding the Development and Commercialization of Compounds and/or Products. During the Term hereof, Zai Lab will provide GSK with annual reports setting forth # a summary of updated development progress and achievements of such Development and Commercialization tasks as set forth in the Development Plan and a listing of any Regulatory Approvals achieved for Products in the Territory, (ii), information relating to any Zai Lab’s sublicensing under or assignment of this Agreement. Upon GSK’s request at any time during the Term hereof, Zai Lab shall provide to GSK a complete list of its licensees and sublicensees of Transferred Know-How and Licensed Patents, as well as a true and complete copy of each license agreement and sublicense agreement (as the case may be) and each amendments thereto within three (3) days after the notification. Any and all such reports (and all data and information set forth therein), lists and agreements shall be considered Zai Lab’s Confidential Information and shall be subject to the confidentiality and use restrictions under this Agreement.

As soon as reasonably practicable but in no case later than […​…] days of the Commencement Date, the parties shall enter into a global pharmacovigilance agreement (“PVA”) setting forth details with respect to the management of safety information including adverse events reports related to the Development and the Commercialization of the Products as well as a Safety Governance Structure and provisions ensuring Neuren has full rights of access to all such information and data.

“Commercialization” shall mean, with respect to Licensed Product, any and all activities directed to the marketing, promotion, distribution, offering for sale and selling such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing. Commercialization shall also include Commercialization Studies. “Commercialize” has a correlative meaning.

SEC Reports; Financial Statements. The Company has filed all reports, schedules, forms, statements and other documents required to be filed by the Company under the Securities Act and the Exchange Act, including pursuant to [Section 13(a) or 15(d)])] thereof, for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material) (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, being collectively referred to herein as the “SEC Reports”) on a timely basis or has received a valid extension or waiver of such time of filing and has filed any such SEC Reports prior to the expiration of any such extension. As of their respective dates, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Company has never been an issuer subject to Rule 144(i) under the Securities Act. The financial statements of the Company included in the SEC Reports comply in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements have been prepared in accordance with United States generally accepted accounting principles applied on a consistent basis during the periods involved (“GAAP”), , except as may be otherwise specified in such financial statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments. The financial data set forth in each of the SEC Reports fairly presents the information set forth therein on a basis consistent with that of the audited financial statements contained in the Company’s SEC Reports.