EAMS and PIP Clause Samples

EAMS and PIP. Nuvectis acknowledges that the inventors of the Licensed Technology have a particular interest in paediatric clinical pathways and care. Accordingly, Nuvectis will, if reasonably practicable, and in good faith, in respect of Licensed Products: 5.11.1 make an application for a PIM designation and if awarded, continue with an application for approval under EAMS. If a positive scientific opinion (or equivalent) is given, continue with a Marketing Authorisation Application and following any Marketing Approval, make Licensed Products available for the approved Indication; and 5.11.2 create a PIP and include paediatric investigations in clinical trials of the Licensed Products, seek Marketing Approval and following any Marketing Approval, make Licensed Products available for the approved Indication. Nuvectis will provide regular written updates on the matters, and its reasonable efforts to expedite access to Licensed Products, as set out in this Clause 5.11.
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