Common use of Process Development Clause in Contracts

Process Development. The current synthesis route for ER-306323 is a complex, [*] step process not readily amenable to large scale Dynthesis. Several alternate routes are currently being evaluated, with selection of a new route required in 2H06. Delivery of the first GMP drug lot is targeted for 1H07. To support early preclinical efficacy pharmacology and safety studies, an initial drug lot, prepared using the current synthetic route, has been initiated. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.

Process Development. The current synthesis route for ER-306323 is a complex, [*] step process not readily amenable to large scale Dynthesis. Several alternate routes are currently being evaluated, with selection of a new route required in 2H06. Delivery of the first GMP drug lot is targeted for 1H07. To support early preclinical efficacy pharmacology and safety studies, an initial drug lot, prepared using the current synthetic route, has been initiated. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.

Process Development. The current synthesis route for ER-306323 is a complex, [*] step process not readily amenable to large scale Dynthesis]. Several alternate routes are currently being evaluated, with selection of a new route required in 2H06[*]. Delivery of the first GMP drug lot is targeted for 1H07[*]. To support early preclinical efficacy pharmacology and safety studies, an initial drug lot, prepared using the current synthetic route, has been initiated. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.