Long-Term Extension Study definition
Long-Term Extension Study means, where applicable, the additional clinical study to be conducted by the Sponsor, which (i) is designed to evaluate the long-term safety, efficacy and quality of the intervention that was the subject matter of the Study-INT and (ii) requires the submission of a new protocol and, where applicable, any additional Approvals.
Long-Term Extension Study means, with respect to each Collaboration Program, the long term extension trial for such Collaboration Program described in the Pre Exercise Development Plan and Budget.”