Qualification Run definition

Qualification Run means a Run used to document the operability and ----------------- reproducibility of the Manufacturing Process at the Genentech Facility, and is described in Section 3.7(b) hereof. --------------
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Qualification Run means a Run conducted (i) to demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, (ii) to establish the comparability of the Product manufactured therefrom to Herceptin manufactured by Genentech as required by the FDA and (iii) to support licensure of both the Facility and the Manufacturing Process at the Facility under the sBLA. Each Qualification Run must be produced from an inoculation of the [*], all in accordance with cGMP and the Manufacturing Documentation.
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Qualification Run means a Run used to document the operability and
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Examples of Qualification Run in a sentence

  • Rules for the FIS Alpine Points Limit of parallel competitions4.4.10 FIS points for the Qualification Run FIS points will be calculated for the European Cup KO and Parallel qualification run.

  • Genentech shall notify Wyeth, in writing, of its election within ten (10) business days after receipt of an investigation report from Wyeth regarding the root cause(s) of the Qualification Run failures.

  • If Genentech fails to so notify Wyeth during such time period, Wyeth shall be deemed to have been authorized to commence [*] Qualification Run Starts.

  • If Genentech fails to so notify Wyeth during such time period, Wyeth shall be deemed to have been authorized to commence [*] additional Qualification Run Starts.

  • Upon Genentech's request and with reasonable prior written notice to Wyeth to permit Wyeth to support such audit, Genentech shall have the right, at its own cost, to conduct a security audit of the Facility and the pertinent records maintained by Wyeth in connection with the security procedures of the Facility, prior to the start of the first Qualification Run.

  • The following proposals for the Parallel Qualification Run to be held at the 2021 World Championships in Cortina d´Ampezzo were approved.Rules for the Qualification Race for Parallel EventQualification races will take place for women and men’s Parallel.

  • The Target Date to manufacture at commercial scale [*] Completed Qualification [*] ("Initial Qualification Run Completion") shall be [*].

  • If Wyeth is authorized to conduct the [*] additional Qualification Runs and yet does not achieve [*] Successful Qualification Batches [*] Qualification Run Starts, Genentech shall either (i) terminate the Transaction Agreements in accordance with Section 21.5.1 or (ii) authorize Wyeth to commence [*] additional Qualification Runs Starts to achieve [*] Successful Qualification Batches [*].


More Definitions of Qualification Run

Qualification Run means a Run used to document the operability and reproducibility of the Manufacturing Process at the Lonza Facility, and is described in Section 4.4.2 hereof.
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Related to Qualification Run

  • 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

  • Qualification Period means the period of time in which a CDC Owner, Operator or a Qualified Colocation Tenant is eligible for Program benefits and means specifically (a) in respect to a CDC Owner or Operator, as defined in subsection IX.A. and (b) in respect to a CDC Qualified Colocation Tenant, as defined in subsection IX.B.

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

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

  • Minimum Qualifications means the requirements of education, training, experience and other basic qualifications for a job.

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

  • 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;

  • pre-qualification means a screening process designed to ensure that invitations to bid are confined to capable providers;

  • Monthly Qualification Cycle means a period beginning one (1) Business Day prior to the first day of the current Statement Cycle through one (1) Business Day prior to the close of the current Statement Cycle.

  • Request for Qualifications means all materials and

  • Evaluation rubric means a set of criteria, measures, and processes used to evaluate all teaching staff members in a specific school district or local education agency. Evaluation rubrics consist of measures of professional practice, based on educator practice instruments and student outcomes. Each Board of Education will have an evaluation rubric specifically for teachers, another specifically for Principals, Vice Principals, and Assistant Principals, and evaluation rubrics for other categories of teaching staff members.

  • Auction Rules means the Mineral (Auction) Rules, 2015 and its subsequent amendments.

  • 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.

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

  • Eligibility Requirements means, with respect to any Person, that such Person has at least $200,000,000 in capital/statutory surplus or shareholders’ equity (except with respect to a pension advisory firm or similar fiduciary) and at least $600,000,000 in total assets (in name or under management), and is regularly engaged in the business of making or owning commercial real estate loans (or interests therein), mezzanine loans (or interests therein) or commercial loans (or interests therein) similar to the Mortgage Loan.

  • EU Securitization Rules means the EU Securitization Regulation, together with any relevant regulatory and/or implementing technical standards adopted by the European Commission in relation thereto, any relevant regulatory and/or implementing technical standards applicable in relation thereto pursuant to any transitional arrangements made pursuant to the EU Securitization Regulation, and, in each case, any relevant guidance published in relation thereto by the European Banking Authority or the European Securities and Markets Authority (or, in either case, any predecessor authority) or by the European Commission.

  • 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.

  • Qualified means that a person holds a certificate, permit or other document equivalent to that which staff in a public school are required to hold to provide special education and designated instruction and services and has met federal and state certification, licensing, registration, or other comparable requirements which apply to the area in which he or she is providing special education or related services, including those requirements set forth in Title 34 of the Code of Federal Regulations sections 200.56 and 200.58, and those requirements set forth in Title 5 of the California Code of Regulations Sections 3064 and 3065, and adheres to the standards of professional practice established in federal and state law or regulation, including the standards contained in the California Business and Professions Code. Nothing in this definition shall be construed as restricting the activities in services of a graduate needing direct hours leading to licensure, or of a student teacher or intern leading to a graduate degree at an accredited or approved college or university, as authorized by state laws or regulations. (Title 5 of the California Code of Regulations Section 3001 (r)).

  • Breach Notification Rule means the HIPAA Regulation that is codified at 45 C.F.R. Parts 160 and 164, Subparts A and D.

  • Qualify or "qualified" means to take the oath of office and begin performing the

  • Qualification Defect With respect to a Mortgage Loan, (a) a defective document in the Mortgage File, (b) the absence of a document in the Mortgage File, or (c) the breach of any representation, warranty or covenant with respect to the Mortgage Loan made by the Company, but, in each case, only if the affected Mortgage Loan would cease to qualify as a “qualified mortgage” for purposes of the REMIC Provisions.

  • Mediation Rules As defined in Section 2.03(h)(i).

  • 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:

  • Level V Status exists at any date if, on such date, the Borrower has not qualified for Level I Status, Level II Status, Level III Status or Level IV Status.

  • Level VI Status exists at any date if, on such date, the Borrower has not qualified for Level I Status, Level II Status, Level III Status, Level IV Status or Level V Status.