Upstream Product Data

Upstream Product Data. Means all data, information and documents from or for the preclinical development, clinical development or regulatory approval of the Product for or applicable to Japan generated by or on behalf of Upstream or its Affiliates , including (as applicable and without limitation) safety data (including serious adverse event data), clinical data, regulatory roadmap and submissions, regulatory compliance information, pharmacovigilance, product quality vigilance, considerations for indication... selection, and clinical trial design. For clarity, all Product data available with the right to transfer to Maruho, to Upstream from its licensees shall be shared with Maruho as Upstream Product Data. 5 View More