I.22.1. The contractor will provide to the Commission, at the latter’s request until full EU marketing authorisation for the Product has been granted, the following physical or electronic data:
(i) updates on progress made in terms of clinical development of the Product; included interim and final results of clinical studies of the Product;
(ii) progress on the build-up of manufacturing capacities;
(iii) updates on progress, challenges and opportunities on establishment of the supply chain; and
(iv) the use of the upfront payments by the Commission and the participating Member States, linked to points (i) to (iii), in general terms;
it being understood that the information pursuant to points (i) through (iii) above shall not [redacted content].
I.22.2. In addition, the contractor shall keep the Commission and the participating Member States informed about any signal detected during the pharmacovigilance or vaccine monitoring programs in relation to the Product within five (5) working days from notifying the EMA.
Section II.7 Processing of Personal Data
II.7.1 Processing of Personal Data by the Commission
Any personal data included in or relating to the APA, including its implementation, shall be processed in accordance with Regulation (EU) 2018/1725. Such data shall be processed solely for the purposes of the implementation, management and monitoring of the APA by the data controller. For the purpose of this provision, the data controller for the Commission shall be the Director-General of the European Commission’s Directorate-General for Health and Food Safety. The data protection notice is available at https://ec.europa.eu/info/data-protection-public-procurement-procedures_en.
The contractor or any other person whose personal data is processed by the data controller in relation to this APA has specific rights as a data subject under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, rectify or erase their personal data and the right to restrict or, where applicable, the right to object to processing or the right to data portability.
Should the contractor or any other person whose personal data is processed in relation to this APA have any queries concerning the processing of its personal data, it shall address itself to the data controller. They may also address themselves to the Data Protection Officer of the data controller. They have the right to lodge a complaint at any time to the European Data Protection Supervisor.
II.7.2 Processing of Personal Data by the Contractor
The processing of personal data by the contractor shall meet the requirements of Regulation (EU) 2018/1725 and be processed solely for the purposes set out by the controller.