Provision Language
I.9 Development Timeline; Special Commitments
I.9.1. The contractor is currently concluding a dose escalating Phase I clinical trial for the Product and is preparing recruitment and start of pivotal Phase IIb/III clinical trial studies. The contractor currently anticipates that the rolling submission of the dossier to the EMA for EU marketing authorisation of the Product will begin in and that conditional EU marketing authorisation may be granted within one or two months after submission, based on anticipated accelerated EMA timelines. However, the Parties acknowledge that there is a risk that (i) a conditional EU marketing authorisation may not be granted and that the placing of the Product on the market may instead require a full EU marketing authorisation and that (ii) an EU marketing authorisation may not be granted at all.
I.9.2. Subject to Article I.7.1, the delivery of the Product to the participating Member States is in principle subject to prior grant of EU marketing authorisation for the Product.
I.9.3. The contractor commits to perform required clinical trials on specific relevant populations such as the elderly, individuals with comorbidities and pediatric populations, as to be further discussed and agreed with EMA, to obtain the EU marketing authorisation.
I.22 Reporting
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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.