Common use of Development Obligations Clause in Contracts

Development Obligations. Each Party shall be responsible for carrying out its activities in accordance with the Development Plan. These activities shall include, without limitation (i) identifying and carrying out all major Development tasks to be conducted prior to submission of filings for Regulatory Approval of a Collaboration Product for a particular indication; (ii) identifying key Development objectives, expected associated resources, risk factors, timelines, go/no go decision points and relevant decision criteria; (iii) carrying out all aspects of (e.g., designing studies and protocols and conducting), and preparing the associated Regulatory Plan for, all clinical trials necessary to obtain Regulatory Approval for each indication pursued, as well as establishing new dosage forms, new formulations or other enhancements of approved Collaboration Products (but excluding Post-Approval Clinical Studies) including, but not limited to (1) establishing/contracting with clinical sites, investigators and contract research organizations ("CROs"), (2) enrolling clinical study patients, (3) organizing investigator meetings, scientific meetings, advisory panel workshops and regulatory meetings, and (4) analyzing, summarizing and presenting clinical study results; (iv) performing any other additional research and pre-clinical research in support of the clinical development of Collaboration Products; (v) forecasting clinical manufacturing production requirements; and (vi) Regulatory Authority reporting on study design, study outcome, other communications and regulatory filings (to the extent not covered by a Regulatory Plan).