Pilot Production Phase definition

Pilot Production Phase shall have the meaning assigned to it in Section 5.1.

Examples of Pilot Production Phase in a sentence

  • The parties recognize that the Project Plan annexed hereto as Exhibit 1 may need to be amended from time to time and Pilot Scope Changes may be required, pursuant to the Scope Change provisions of Section 3.10, in order to accomplish the purpose and achieve the goals of the Pilot Production Phase.

  • KMC shall use good workmanship in performing all Pilot Production Phase activities and the Pilot Instruments shall meet the applicable quality and regulatory requirements of Article VII.

  • The parties recognize that the Project Plan may need to be amended from time to time and Pilot Scope Changes may be required, pursuant to the Scope Change provisions of Section 3.10, in order to accomplish the purpose and achieve the goals of the Pilot Production Phase and that the current cost estimate may change as a result.

  • KMC will generally execute all Pilot Production Phase activities in accordance with the Project Plan tasks initially set forth in Exhibit 1 and shall use all reasonable commercial efforts to meet the schedule set forth in the Project Plan, subject to Pilot Scope Changes, which currently provides for manufacture of Pilot Instruments to begin February 12, 2001, to be delivered commencing March 16, 2001.

  • After production of the Pilot Instruments begins, KMC shall provide Gen-Probe with regular periodic reports, no less than every two (2) weeks, stating the current status of the Pilot Production Phase and updating the Project Plan.

  • KMC shall assign the key members of the project team identified on Exhibit 3 to the Pilot Production Phase and such team shall be made available for as much time as necessary to accomplish successful execution of the Pilot Production Phase.

  • The parties recognize that as a result of Pilot Scope Changes, and the other Scope Changes, and related activities, it may be advisable to change and/or add certain project team personnel for the Pilot Production Phase.

  • The purpose of the work described in this Article V (the "Pilot Production Phase") will be to manufacture eight (8) pilot versions of the Instruments (the "Pilot Instruments") and to prepare to proceed with the manufacture of Production Instruments pursuant to Article VI, initially in accordance with the Project Plan tasks identified in Exhibit 1.

Related to Pilot Production Phase

  • Development Phase means the period before a vehicle type is type approved.

  • Commercial Production means the operation of the Property or any portion thereof as a producing mine and the production of mineral products therefrom (excluding bulk sampling, pilot plant or test operations);

  • Production Period is the period that for winter cereal advances commences October 1, 2021 and terminates September 30, 2023; for advances on all other field crops, honey, hogs, goats, sheep and lambs commences April 1, 2022 and terminates September 30, 2023; and for advances on cattle, continuous flow cattle, and bison commences on April 1, 2022 and terminates on March 31, 2024.

  • Construction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8.

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Construction Phase means that Phase of the Project which shall commence after the Authority provides the Trade Contractor with written Notice to Proceed with the Construction Phase.

  • Commencement of Commercial Production means: (i) if a mill is located on the Property, the last day of a period of 40 consecutive days in which, for not less than 30 days, the mill processed ore from the Property at 60% of its rated concentrating capacity; or (ii) if a mill is not located on the Property, the last day of a period of 30 consecutive days during which ore has been shipped from the Property on a reasonably regular basis for the purpose of earning revenues, but any period of time during which ore or concentrate is shipped from the Property for testing purposes, or during which milling operations are undertaken as initial tune-up, shall not be taken into account in determining the date of Commencement of Commercial Production;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Production Area means that part of the animal feeding operation that includes the animal confinement area, the manure storage area, the raw materials storage area, and the waste containment areas. The animal confinement area includes, but is not limited to, open lots, housed lots, feedlots, confinement houses, stall barns, free stall barns, milkrooms, milking centers, egg washing or egg processing areas, areas used for the storage and disposal/treatment of mortalities, cowyards, barnyards, medication pens, walkers, animal walkways, and stables. The manure storage area includes, but is not limited to, lagoons, runoff ponds, storage sheds, stockpiles, under-house or pit storages, liquid impoundments, static piles, and composting piles. The raw materials storage area includes, but is not limited to, feed silos, and silage bunkers. The waste containment area includes, but is not limited to, settling basins and areas within berms and diversions which separate uncontaminated stormwater.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Pilot project means an innovative environmental project that covers one or more designated facilities, designed and implemented in the form of an EMSA. (See Section 52.3 of the Act.)

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.

  • Development Project means a project for the development of land within a project area.

  • 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.

  • Operating pressure means the pressure at which the parts of an irrigation system are designed by the manufacturer to operate.

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • 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;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • Development Area means that area to which a development plan is applicable.