Provision Language
I.22 Reporting
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].
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.