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.
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Validation Lots shall man those lots described in Paragraph 2.2.
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Validation Lots means the initial number of lots of the Product, manufactured by Nastech during the course of the Process Development/Validation Activities.
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Examples of Validation Lots in a sentence

  • 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.

  • Barrier shall not pay DSM for Validation Lots which fail to meet the Specifications due to the fault or negligence of DSM.

  • Therefore, any part of the Validation Lots which the Parties determine does not meet the Specifications shall not be subject to the warranty contained in Section 5.1 hereof or to the claims procedures set forth in Section 12.1 hereof; and, unless the failure of such nonconforming Validation Lot is due to the negligence or fault of DSM, Barrier shall pay DSM the full Product Price for such nonconforming Validation Lots as set forth in Section 8.1 hereof.

  • For all Product Validation Lots rejected by AMYLIN, MALLINCKRODT shall, upon request from AMYLIN and at AMYLIN’s option, (x) promptly replace such Lot at no additional expense to AMYLIN, (y) promptly remedy the deficiency at MALLINCKRODT’s expense, or (z) immediately refund any amounts paid by AMYLIN for such rejected Lot.

  • 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.

  • Subject to Section 2.4 (Purchase of Validation Lots of Drug Substance) hereof, all costs related to such activities shall be for the sole account of Nisso.

  • It is agreed that the remedies set forth in the immediately preceding sentence are AMYLIN’s sole remedies in the event of any rejection by AMYLIN of Product Validation Lot(s).

  • Disposal of rejected Product Validation Lots and all work associated with completing all Validation Requirements to ensure that Product Validation Lots meet all Validation Requirements (including without limitation re-manufacture of Product Validation Lots to bring such Lots into conformance with Governmental Agency requirements) shall be at the sole cost and expense of MALLINCKRODT.

  • If, after AMYLIN’s acceptance of any Product Validation Lot, AMYLIN rejects any of the other Product Validation Lots, then AMYLIN will have the right to reject any or all Product Validation Lots that were previously accepted as not being in compliance with the requirement in Paragraph 8.1(vi) that all Product Validation Lots meet all Validation Requirements upon delivery to AMYLIN.

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


More Definitions of Validation Lots

Validation Lots shall have the meaning ascribed thereto in Section 5.3 hereof.
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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 subdivision with lots clustered in a group of five or more lots that is

  • 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;

  • 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.

  • Phase II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).

  • Construction in Progress means each Property that is either (a) new ground up construction or (b) under renovation in which (i) greater than thirty percent (30%) of the square footage of such Property is unavailable for occupancy due to renovation and (ii) no rents are being paid on such square footage. A Property will cease to be classified as “Construction in Progress” on the earlier to occur of (A) the time that such Property has an Occupancy Rate of greater than eighty percent (80%), or (B) one hundred eighty (180) days after completion of construction or renovation of such Property, as applicable.

  • 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 or "PMP" means the Wash- ington state prescription monitoring program authorized under chapter

  • 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 designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase 2 means the phase of the ATP comprised of: (1) improvements to the State Street Substation to receive Rebuilt Line 972; (2) the rebuilding of NYSEG’s existing Line 972 not performed in Phase 1; (3) construction of Relocated Line 15; (4) the construction of Bused Line 5; (5) improvements to the Elbridge Substation to receive Relocated Line 15; and (6) improvements to the Elbridge Substation to receive Bused Line 5.

  • 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 human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.