Development Information

Development Information. Any and all information generated by a party (or a party's Affiliates or any Third Party on behalf of a party) in the development of the Drug Substance and/or Product for the Territory as provided in this Agreement, including, without limitation, protocols, analysis plans, annotated case report forms per study, analysis datasets, programs, raw data and other relevant documentation used for the study reporting efforts, FDA outputs relating to the development of, and/or filing of NDAs for, Drug... Substance and/or Product in the Territory (including, without limitation, all substantive correspondence with the FDA, responses from the FDA, requests for information from the FDA, briefing documents and other materials relating to interactions with the FDA, and summaries of outputs resulting from substantive correspondence/ conversations or meetings with the FDA), and information from clinical advisory boards and investigators View More