The Parties acknowledge that in the Paediatric Investigation Plan (PIP) submitted by LICENSOR in the Territory, the PIP Trial will need to be conducted to obtain the benefit of the approval, and such trial will be the responsibility of the LICENSOR provided always that IMMEDICA shall reimburse LICENSOR for ​ of the out-of-pocket external costs reasonably and actually incurred by the LICENSOR, solely and directly in relation to the conduct of the PIP Trial up to ​. Such costs shall be payable in U.S. Dollars upon receipt by IMMEDICA of reasonable written evidence of such external costs, in accordance with Section 6.

Development. [Section 4.1(d)] is hereby deleted in its entirety and replaced with the following:

Development. Notwithstanding Section 3.1(a), the Parties may agree in a Schedule that, for a specified time period and/or disease indication as set forth in the Schedule, neither QIAGEN nor its Affiliates will develop, acquire, license, manufacture or distribute for itself, or enter into any agreement or relationship with a third party to develop, acquire, license, manufacture or distribute any Competing QIAGEN Test. Any such agreement by QIAGEN in a Schedule shall be subject to good faith negotiation of compensation to QIAGEN for the foregoing restriction.

Development. Each Party will be responsible, at its own expense, for conducting Development in its Territory and as set forth in this Section 3.2.

Development. On a Collaboration Tumor Type-by-Collaboration Tumor Type basis, for so long thereafter as Providence’s license under Section 4.1 for such Collaboration Tumor Type remains in effect (during which period such Collaboration Tumor Type shall be a “Licensed Collaboration Tumor Type”), Providence shall be responsible in its sole discretion for the Development of Collaboration Compounds and Products for such Licensed Collaboration Tumor Type in the Licensed Field in the Territory (other than the activities assigned to Arcturus under Section 5.2).

Development. providing guidance, reviewing, and approving the implementation by the JDC of the Development strategy and the Development Plan for each of the Licensed Product(s), including the regulatory strategy and conduct of regulatory activities for each of the Licensed Product(s);

Development and Development Plan. The initial development plan for the Compound and the Products is attached hereto as [Exhibit A]. If ​, Licensee will promptly submit to MSD an updated development plan (such initial development plan, as updated, the “Development Plan”). Licensee will Develop the Compound and the Products in the Field in the Territory # ​, and # in a ​ and in compliance with Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices and all other Applicable Laws.

Development Reports. In advance of each JSC meeting, unless otherwise agreed between the Parties, Janssen shall provide to the JSC a high-level summary report summarizing its Development activities with respect to each Licensed Product and the results thereof since the previous JSC meeting, and its anticipated Development activities with respect to each Licensed Product for the subsequent calendar quarter. At each JSC meeting, Janssen shall provide additional information as reasonably requested by Fate’s JSC representatives with respect to the Development activities summarized in such report or otherwise conducted or anticipated to be conducted for Licensed Products.

Development Reports. In advance of each meeting of the JDC, unless otherwise agreed between the Parties, Janssen will provide to the JDC a ​.

Development Plan. All Development of the Products in the Territory will be governed by a written development plan, as such development plan may be revised by Akebia in its sole discretion from time to time (the “Development Plan”). The initial Development Plan is attached hereto as [Schedule 3.3]. For the avoidance of doubt, Akebia is under no obligation to provide Cyclerion notice of, or copies of, any changes to the Development Plan.