Development Costs. Except as otherwise provided in this Agreement, Akebia shall be responsible for all of its costs and expenses in connection with the Development of, and obtaining and maintaining Regulatory Approvals for, the Products in the Field in the Territory.

Development Materials. The Parties acknowledge that, as of the Effective Date, Cyclerion is in the physical possession of that inventory of ​ (collectively, [***] the “Development Materials”), in each case, as set forth on [Schedule 11.1(u)]. Promptly after the Effective Date and pursuant to the terms of the Supply Agreement, Cyclerion shall supply Akebia with all Development Materials that Cyclerion controls, including those materials in the possession of Cyclerion’s Third Party contract manufacturers, and that are listed on [Schedule 11.1(u)], at no cost to Akebia, and Cyclerion shall transfer title to Akebia to all such Development Materials in accordance with the terms of the Supply Agreement. Cyclerion hereby agrees to manage any storage, handling, and shipment of such inventory in accordance with Akebia’s reasonable written directions and, as applicable, the terms of the Supply Agreement, including by transferring such Development Materials to Akebia or its designee at Akebia’s direction.

Development Plan. Licensee shall develop Products in the Field in the Territory pursuant to the Development Plan. The Development Plan includes # an outline of all major development activities for Products for each Indication within the Field in the Territory to be conducted by or on behalf of Licensee, its Affiliates, or its or their Sublicensees, including clinical/non-clinical development activities necessary for obtaining and maintaining the MAAs for the Products in the Field in the Territory; # estimated timelines for the conduct of such major development activities and for MAA applications for the Products in each Indication the Field in the Territory; and # estimated timelines of any other major development activities in the Territory, including any participation in any investigator-initiated clinical studies of a Product.

Development Milestones. Within ​ after the first achievement by any Product of each of the milestone events set forth in the table below, Licensee shall provide Verrica with written notice of such achievement. Within ​ upon receipt from Verrica of an invoice and all Tax Documents for the relevant amount payable to Verrica under this Section 8.2, Licensee shall pay to Verrica the corresponding non-refundable, non-creditable milestone payment set forth in such table.

Global Development. The Party to which a particular Development activity is allocated under the Global Development Plan will lead the performance thereof and all Clinical Trials and Development activities for the Licensed Antibody and Licensed Product in the Territory will be conducted by the Parties as set forth in the Global Development Plan.

Development Diligence. Each Party will use Commercially Reasonable Efforts to perform the obligations assigned to it under the Global Development Plan. GSK (directly, or through its Affiliates, its or their Sublicensees and subcontractors) will use Commercially Reasonable Efforts to Develop the Licensed Products in the Field in the Territory, including to obtain and maintain Regulatory Approval of Licensed Products in the Field in the United Kingdom, Germany, Italy, France, Spain, China, Japan, and, in the event that ITEOS has delivered an Opt-Out Notice, the United States.

Development Reporting. ​, with respect to any Development activities conducted by or on behalf of either Party with respect to the Licensed Antibodies or Licensed Products under this Agreement, within ​ following the end of ​, each Party shall prepare and provide to the other Party and the JDC (or the JSC, if the JDC is no longer meeting) a detailed written report that summarizes: # the Development activities (including CMC Development and other Manufacturing-related Development activities) performed and the status of activities and progress with respect to the activities set forth in the Global Development Plan (including enrollment data), and shall identify any issues or circumstances of which it is aware that may prevent or adversely affect in a material manner its future performance of activities assigned to it under the then-current Global Development Plan, and # all material Data generated since the last ​ report (each, a “Development Report”). Solely in the event that, and for so long as, the effects of forced opt-out set forth in [Section 6.7.4] (Effects of Forced Opt-Out) apply, the Development Reports provided by GSK to the JSC pursuant to this [Section 3.6] (Development Reporting) will include GSK’s ​ ITEOS’s JSC representatives may review, but will have no right to comment on or approve. Each Party and the JDC (or the JSC, if the JDC is no longer meeting) shall have the right to review all reports and Data related to any Clinical Trials for a Licensed Product, whether such reports are generated by or on behalf of GSK, ITEOS, a Sublicensee or a subcontractor. Each Party will respond to the reasonable questions or requests of the other Party’s JDC representatives (or JSC representatives, if the JDC is no longer meeting), as applicable, for additional information relating to such Party’s Development activities under this Agreement in a timely manner.

Each Party shall maintain records of its activities under the Global Development Plan and for Clinical Studies, Post-Approval Commitment Studies and Phase IV Studies of Product conducted pursuant to this Agreement outside the Global Development Plan (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of the development.

Development Strategy. Within one (1) year after the Effective Date or at such other time as the Parties may mutually agree, the China Committee will prepare an overall development strategy for the Product in the Field in the Territory including the indications (or other life cycle management) the Parties are considering to develop (or conduct) throughout the Territory, which strategy will include the anticipated dates (estimated based on the date of completion of certain development events) for preparing detailed descriptions of applicable events for inclusion in an amended Development Plan (the “Development Strategy”). The Development Strategy will include reasonable timelines for any additional indications to be developed hereunder, with the understanding that not all such indications will be developed concurrently.

Development Responsibilities. Unless the Parties agree in writing upon an alternate allocation of responsibility, FibroGen China shall be responsible for conducting the Clinical Trials under the Development Plan in accordance with GCP and all applicable laws and regulations. The Development Plan shall specify success criteria and a timetable for the completion of such Clinical Trials.