Validation Lots definition

Validation Lots for a dosage form shall mean shall mean the initial number of Lots, which shall be at least three (3) Lots or such additional Lots as mutually agreed, of the Product which are manufactured by DSM during the course of the Validation Activities.
Sample 1Sample 2
Validation Lots shall have the meaning ascribed thereto in Section 5.3 hereof.
Sample 1
Validation Lots shall man those lots described in Paragraph 2.2.
Sample 1

Examples of Validation Lots in a sentence

  • In the literature, trade bias is a measure of the net effect of trade creation and trade diversion.

  • Supplier has completed all manufacturing services required by Company under the Supply Agreement, specifically within the scope of Paragraphs 2(a) and 12 and relating to the Pilot and Validation Lots of CCA and Compound.

  • It was also recommended to require PIRC to post yearly surety bond callable on demand as security on the rental deposit for the duration of the Contract of Lease, considering that PAGCOR had already past experiences of uncollected rental deposits.

  • Validation Lots: MLS understands the regulatory requirement to validate three successive production lots for critical biological reagents used in commercial products.

  • If the Expected Loss for the first three (3) Validation Lots run under this Agreement is greater than [***], the parties shall then mutually agree upon a revised Expected Loss based upon the average of the actual loss resulting from the [***] completed commercial lot Batches that return an actual loss of not more than [***] and at such time the revised Expected Loss shall be then established and applied against future Batches.

  • In August 2020, the transaction was completed and the buyer paid the Group a total of EUR 57.4 million, while at the same time the bank loan was repaid for the property that remained at the time of the transaction, amounting to approximately EUR 23.3 million.

  • Upon DSM’s completion of production of Validation Lots and pre-launch Commercial Product Lots prior to the First Commercial Sale, Barrier shall pay DSM *** of the Product Price for such Lots.

  • AMYLIN and LONZA agree that delivery by LONZA to AMYLIN of […***…] overage of Product from Product Validation Lots replaces in full the Purchase Order for […***…] of Product for delivery in the second half of 2009, which Purchase ***Confidential Treatment Requested 6.

  • These results will not be discussed here in detail, however, important findings and conclusions will be summarized now: - Validation: Lots of additional thermocouples have been installed inside the PMA4 in course of the construction for to get more information about establishment of the steady state, but also for validation of the FEM simulations.

  • Development Lots: [***] [***] Validation Lots[***] [***] CAPITAL REIMBURSEMENT: OSG Norwich shall purchase the following equipment required to manufacture the Product.


More Definitions of Validation Lots

Validation Lots means the initial number of lots of the Product, manufactured by Nastech during the course of the Process Development/Validation Activities.
Sample 1

Related to Validation Lots

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • stacked townhouse means a building, other than a townhouse or apartment building, containing at least 3 dwelling units, each dwelling unit being separated from the other vertically and/or horizontally, and each dwelling unit having an entrance to grade shared with no more than 3 other units;

  • Cluster development means a contiguous cluster or

  • Loan Program means the State Treasurer’s Interest-Free Loan Program for Colorado School Districts authorized pursuant to the Loan Program Statutes.

  • Finished Lots Entitled Land with respect to which (a) development has been completed to such an extent that permits to allow use and construction, including building, sanitary sewer and water, are entitled to be obtained for a Unit on such Entitled Land and (b) start of construction has not occurred.

  • Modular home means a modular unit as defined in Section 15A-1-302.

  • Lots means all or any machinery and other items sold or intended to be sold in accordance with these conditions; “Purchaser” means a person, firm or Company who purchase any Lot;

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Construction in Progress means, as of any date, the book value (determined in accordance with GAAP) of any Projects then under development; provided that a Project shall no longer be included in Construction in Progress and shall be deemed to be a stabilized project upon the earlier of (a) the expiration of the second full fiscal quarter after substantial completion (the earlier of receipt of a temporary certificate of occupancy or a final certificate of occupancy) of such Project and (b) the last day of the fiscal quarter in which the annualized Consolidated Net Operating Income attributable to such Project divided by the Capitalization Rate exceeds the book value of such Project.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Prescription monitoring program means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external

  • Cannabis testing facility means an entity registered by

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Cannabis establishment means a cannabis cultivator, a cannabis manufacturer, a cannabis wholesaler, or a cannabis retailer.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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).

  • Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Number of Students Who Began Program means the number of students who began the program who are scheduled to complete the program within the reporting calendar year.

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.