Common use of Development and Regulatory Matters Clause in Contracts

Development and Regulatory Matters. A. Somaxon shall be solely responsible for conducting and paying for all clinical trials and for all regulatory filings/interactions, including pharmacovigilance related to the Licensed Product(s). B. Synchroneuron shall provide reasonable and appropriate assistance to Somaxon on the design and implementation of the clinical trials and such other matters relating to the Licensed IP as may be mutually agreeable to the parties. Somaxon shall promptly reimburse Synchroneuron, Advisor and Dr. Steven K. Gold for all expenses reasonably incurred by them duri▇▇ ▇▇▇▇▇▇▇▇▇▇e of such assistance or for other services approved by Somaxon in advance of performance upon presentation of receipts. C. Somaxon shall file for and hold any related NDA and other similar foreign regulatory filings related to the Licensed Product(s) in its name. Synchroneuron shall be entitled to have a representative attend and participate in (i) each meeting during which Somaxon's strategy with respect to meetings with the FDA or other like foreign government body is discussed and (ii) each meeting with the FDA or other like foreign government body during the conduct of Phase 2 Clinical Trials and Phase 3 Clinical Trials.