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 Responsibility. Coya, directly or through any Affiliates or Sublicensees, shall have sole responsibility for the conduct of Development activities under this Agreement and shall bear all costs and expenses incurred in connection with such Development activities. Notwithstanding the foregoing, Coya shall use Commercially Reasonable Efforts, either directly or through any Affiliates or Sublicensees, to Develop and obtain Regulatory Approval for at least one Product, in the United States, the Major EU Markets or Japan.

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 Reports. Until the First Commercial Sale of a Product, Coya will provide to ARScience Bio, within 60 days after the end of each Calendar Year, a written report summarizing Coya’s and its Affiliates’ and Sublicensees’ activities to Develop the Licensed Compound and Products, including # a high-level summary of the data and results of such Development efforts and # identification of # the Regulatory Approval Applications that Coya or its Affiliates or Sublicensees have filed, sought or obtained in the prior 12-month period and # any such filings they reasonably expect to make, seek or attempt to obtain in the following 12-month period. Within 30 days after receipt of each report under this Section 3.1.3 (Development Reports), ARScience Bio may request a meeting (including by teleconference or videoconference) with representatives of Coya to discuss the report and the status of Development of Products, the location and date of such meeting to be mutually agreed upon by the Parties.

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

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 Plans. Within 90 days after the Effective Date, Coya will provide to ARScience Bio a high level development plan for Products, describing at a high level the Development activities for Products to be carried out by Coya or its Affiliates or Sublicensees, including the specific objectives and an anticipated timeline for such activities (as may be updated from time to time in accordance with this Agreement, the “Development Plan”). At any time during the Term and, in any event, not less frequently than annually, Coya may provide to ARScience Bio an updated Development Plan.

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).