Purpose and Governance. 2.1 The Parties have agreed to the coordination of the Function on a joint regional basis following the conclusion reached by the Parties that the Function can be most effectively and efficiently achieved by the use of a Lead Force model whereby the management and the provision of the Function is undertaken by WYPCC and PCCWY as the Lead Force subject to clause 2.2 below and the Governance Arrangements as set out in the Framework Agreement.
Purpose and Governance. 2.1Plans. IVS and APR agree to collaborate to Develop and obtain Regulatory Approval of the Assay and/or the IVD Kit in accordance with this Agreement, and, as applicable, the Project Plan. The Project Plan and the accompanying Budget is for the Assay as a [***] assay [***], after Regulatory Approval of the Assay and for the Target Countries of the United States, the member states of the EU, and the United Kingdom. This Agreement shall govern the conduct of the Project Plan attached hereto, as amended, which may be approved by the JSC from time to time. IVS shall perform the Activities and provide the Deliverables as set forth in the Project Plan with the standards of care and skill to be reasonably expected in the field of Developing in vitro diagnostics and companion diagnostics, including adherence to applicable QSR and cGCP practices. The Parties shall cooperate in good faith to achieve the results contemplated in the Project Plan, including the Development of the Assay and IVD Kit.
Purpose and Governance
