Qualification Batch definition

Qualification Batch or "Qualification Lot" means a Batch or Lot produced ------------------- ----------------- from a Qualification Run.
Sample 1
Qualification Batch has the meaning set forth in the MDSA.
Sample 1Sample 2
Qualification Batch means a Lot of Active Ingredient that meets Specifications and is manufactured following a work plan and in compliance with cGMPs and Applicable Laws to assess the critical parameters and test the proper functioning of a manufacturing process.
Sample 1

Examples of Qualification Batch in a sentence

  • Subject to FDA regulations, Genentech may make whatever further use of such Qualification Batches in the Territory, including, without limitation, any saleable Product therefrom, as it shall determine appropriate; provided, however, Genentech shall not sell or otherwise use in humans any Product from any Qualification Batch that is not a Successful Qualification Batch, was not manufactured in accordance with cGMP standards, or is otherwise not useable for such purposes.

  • For each Successful Qualification Batch [*] manufactured by not later than [*]and in compliance with this Agreement and conformance to cGMP, the Bulk Drug Specifications, the Target Yield, and the warranties provided in Section 7.1 hereof, Genentech shall pay Lonza an amount equal to [*] per Batch and, subject to Section 4.5, the Acquisition Cost of raw materials used to manufacture each such Batch.


More Definitions of Qualification Batch

Qualification Batch or "Qualification Lot" means a Batch or Lot produced
Sample 1
Qualification Batch means a batch of a Bulk Product SKU or API (as applicable) that meets the Specifications and that is in compliance with applicable Laws that is Manufactured to assess the ability of a party to Manufacture such batch in accordance with the then-current Manufacturing process.
Sample 1

Related to Qualification Batch

  • Qualification Date means the date as of which the Offering Statement was or will be qualified with the Commission pursuant to Regulation A, the Act and the Rules and Regulations; and

  • Prequalification means the process set out in the Rules for determining whether an applicant is eligible to bid in a capacity auction in respect of a CMU;

  • Qualification Period means the period of time in which the List of Approved Suppliers shall be valid in accordance with the Tender; in which the Company shall have the right, at any time to issue Purchase Order(s) for Goods and/or to approach any or all of the Approved Suppliers and invite them, by way of RFQ to supply Goods, all in accordance with the terms and conditions of the Contract.

  • Qualification Deadline has the meaning set forth in Section 2(a)(ii).

  • Qualification Requirements means the qualification requirements as set forth in Section-2, Clause 2.1 of this RFP;

  • Request For Qualifications (RFQ means the written solicitation, including all Addenda thereto, issued by the Department seeking SOQs in order to identify and Short-List the Proposers to receive the RFP for the Project.

  • Minimum Qualifications Qualifications mandated for the position and which must be possessed by an employee before the employee can be considered for employment in a specific classification.

  • pre-qualification means the first stage of the Bidding Process involving the submission, opening and evaluation of the Qualification Documents submitted by the Prospective Bidders.

  • Qualification means any degree, diploma or certificate conferred upon a person after having been examined in respect of that person’s proficiency in a particular field of study;

  • Request for Qualifications means all materials and

  • Qualifications , in relation to an employee, means any degree, diploma or other academic, technical or professional qualification relevant to the position which he held.

  • Open type traction battery means a type of battery requiring filling with liquid and generating hydrogen gas that is released to the atmosphere.

  • Impermissible Qualification means, relative to the opinion or certification of any independent public accountant as to any financial statement of the Borrower, any qualification or exception to such opinion or certification:

  • Eligibility and selection criteria means criteria for determining:

  • Nondisqualification Opinion An Opinion of Counsel, prepared at the Trust’s expense and payable from the Collection Account, that a contemplated action will not cause (i) either the Lower-Tier REMIC or the Upper-Tier REMIC to fail to qualify as a REMIC or (ii) a “prohibited transaction” or “prohibited contributions” tax to be imposed on either the Lower-Tier REMIC or the Upper-Tier REMIC at any time that any Certificates are outstanding.

  • Statement of Qualifications means a written statement submitted to a procurement unit in response to a request for statement of qualifications.

  • Eligibility Requirement means all eligibility requirements and other qualification requirements for a person to act in the applicable Corporate Trust Capacity under any Appointment as set forth in the related Corporate Trust Contract, including any required authorizations or licenses from the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, the Government National Mortgage Association, the Federal Housing Administration, the Federal Home Loan Bank or the Department of Veterans Affairs.

  • Statewide special election means a special election called by the governor or the

  • Statewide popular election means a general election in which

  • Local special election means a special election called by the governing body of a

  • Eligibility Requirements means, with respect to any Person, that such Person (i) has total assets (in name or under management) in excess of $600,000,000 and (except with respect to a pension advisory firm or similar fiduciary) capital/statutory surplus or shareholder’s equity of $250,000,000 and (ii) is regularly engaged in the business of making or owning commercial real estate loans or operating commercial mortgage properties.

  • Disqualification means the Athlete’s results in a particular Competition or Event are invalidated, with all resulting Consequences including forfeiture of any medals, points and prizes;

  • TLAC Disqualification Event means OSFI has advised the Bank in writing that the bail-inable notes issued under the applicable pricing supplement will no longer be recognized in full as TLAC under the TLAC Guideline as interpreted by the Superintendent, provided that a TLAC Disqualification Event will not occur where the exclusion of those bail-inable notes from the Bank’s TLAC requirements is due to the remaining maturity of those bail-inable notes being less than any period prescribed by any relevant eligibility criteria applicable as of the issue date of those bail-inable notes.

  • Qualifying country component means a component mined, produced, or manufactured in a qualifying country.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;