Initial Period means the period from (and including) the Issue Date to (but excluding) the First Call Date;
Development Phase means the period before a vehicle type is type approved.
Initial Placement shall have the meaning set forth in the preamble hereto.
Phase III means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.
Project Year means the 12 month period beginning from the Effective Date and ending 12 months thereafter and each successive 12 month period following thereafter;