Launch Date has the meaning specified therefor in Section 2.02(b) of this Agreement.
Commercial Launch means the initial First Commercial Sale of a Product in the Territory.
Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:
Contract Year means each period of twelve (12) consecutive months during the Initial Term of this Agreement, with the first Contract Year commencing on the Effective Date, and with each subsequent Contract Year commencing on the anniversary of the Effective Date.
FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.
Scheduled Downtime has the meaning set forth in Section 5.2.
Contract Quarter means a three-month period that commences on January 1, April 1, July 1 or October 1 and ends on March 31, June 30, September 30, or December 31, respectively.
Supply Period means the period commencing on the Supply Period Start Date and terminating on the Termination Date.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Project Year means the twelve-month period beginning from the Effective Date and ending twelve months thereafter (the First Project Year), and any twelve-month period beginning at the end of the First Project Year, or the end of subsequent Project Years;
Scheduled Completion Date shall be the date set forth in Clause 10.3;
Actual Uptime means, of the Total Operation Hours, the aggregate number of hours in any month during which each equipment is actually available for use.
Commercial Sale means the sale of Product (as indicated by shipment of Product) to an unaffiliated third-party of the Licensee, or of its sublicensee or distribution partner, such as a wholesaler, managed care organization, hospital or pharmacy and shall exclude (i) any transfer of Product by Licensee to its sublicensee, distribution partner or Affiliate and (ii) any distribution of Product for use in research, development, pre-clinical and clinical trials.
Product Schedule means the “Product Schedule” that forms part of the Contract.
Planned Outage means the removal of equipment from service availability for inspection and/or general overhaul of one or more major equipment groups. To qualify as a Planned Outage, the maintenance (a) must actually be conducted during the Planned Outage, and in Seller’s sole discretion must be of the type that is necessary to reliably maintain the Project, (b) cannot be reasonably conducted during Project operations, and (c) causes the generation level of the Project to be reduced by at least ten percent (10%) of the Contract Capacity.
Milestone Event has the meaning set forth in Section 8.2.1.
Shipment Date , in relation to a mineral, means —
Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting the approval of the Drug Approval Application for such Licensed Product to support an application for regulatory approval of another product for any indication without the prior written consent of the Drug Approval Application holder.
Scheduled Commercial Operation Date shall have the meaning ascribed to it in Clause 5.4.1;
Project Milestone means the project milestone set forth in Schedule-J;
Planned Downtime means planned downtime for upgrades and maintenance to the Services scheduled in advance of such upgrades and maintenance.
Quarterly (1/Quarter) sampling frequency means the sampling shall be done in the months of March, June, August, and December, unless specifically identified otherwise in the Effluent Limitations and Monitoring Requirements table.
Forecast GDP means the average forecast for British Columbia’s real GDP growth made by the Economic Forecast Council and as reported in the annual February budget of the government;
Development Milestone Event has the meaning set forth in Section 7.2.1.
Gross Standard Volume as herein used means volume corrected to a temperature of sixty degrees (60°) Fahrenheit, in accordance with the latest API/ASTM measurement standards, and at equilibrium vapor pressure.
Target Completion Date has the meaning given such term in Section 3.3(b).