DEVELOPMENT STEPS definition
DEVELOPMENT STEPS means the activities specified in Exhibit hereto to be undertaken by the parties during the Development Period.
DEVELOPMENT STEPS means those activities to be undertaken by Fovea for each Collaboration Combination or Licensed Combination, as applicable. Fovea must follow these Development Steps:
(a) The Collaboration Combination or Licensed Combination shall enter formulation development;
(b) If the Collaboration Combination or Licensed Combination can be formulated for ophthalmic use, it shall be advanced to animal ocular tolerability experiments;
(c) If the Collaboration Combination or Licensed Combination has acceptable ocular tolerability properties, it shall be advanced to animal proof-of-concept efficacy models;
(d) If the Collaboration Combination or Licensed Combination is efficacious in animal models it shall be advanced to ocular toxicity and pharmacokinetic studies; and
(e) If the Collaboration Combination or Licensed Combination is tolerable, non-toxic, efficacious, and can be formulated for ophthalmic use, it shall be advanced to a Phase I human safety/pharmacokinetic study.