Qualification and Validation Sample Clauses

Qualification and Validation. LONZA shall be responsible for validating the LONZA Equipment used for supply of Product or, if applicable, performance of the Services (including conducting installation, operational and performance qualification), and the production, cleaning and, to the extent applicable, packaging processes, as well as all other appropriate steps performed at the Facilities. All activities and procedures must: (i) meet applicable regulatory requirements; and (ii) be found acceptable by Regulatory Authority inspectors, if applicable. If any Regulatory Authority finds LONZA’s validation procedures to be unacceptable, then LONZA will take (or have taken) appropriate remedial measures, including repeating the validation as necessary, such that the validation procedures meet all applicable regulatory requirements and guidelines, including those necessary to receive all Regulatory Authority approvals. If any of LONZA’s validation procedures fail to comply with cGMP or the Specifications, LONZA shall promptly remedy such failure in order to comply with all cGMP and Specifications. Furthermore, LONZA shall also be responsible for validating the MODERNA Equipment under the terms set forth above when agreed upon in the relevant Statement of Work.
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Qualification and Validation. 4.5.2.1. Agilent will be responsible for the qualification and validation of manufacturing and testing equipment and processes, as mutually defined by Agilent and Ophthotech.
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Qualification and Validation. The ACCEPTOR agrees that the distribution system used must be validated. Furthermore, the documentation as laid down in the specifications shall be followed, using calibrated and qualified equipment, computer systems and machines.
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Qualification and Validation. NOVARTIS agrees that manufacturing, in-process and quality control, and cleaning procedures must be validated and carried out under cGMP rules. Furthermore, the manufacturing instructions shall be followed using calibrated and qualified equipment, computer systems and machines.
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Qualification and Validation. The following qualification and validation activities are included in the Base Fee, and only relates to the 20ml vial.
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Qualification and Validation a. AVECIA will perform appropriate installation qualification (IQ), operational qualification (OQ), and/or performance qualification (PQ) for the required classes of equipment used and process used for the production and control of AGU. Evaluation and/or re-validation will be conducted in accordance with appropriate specifications/ procedures. X Confirm in audit b. Documentation of such activities and/or schedule of revalidation shall be the responsibility of AVECIA. X Confirm in audit c. Documentation shall be available to DYNAVAX or partners, upon mutual agreement with AVECIA, or Regulatory Authorities upon request. X
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Qualification and Validation. Qualification and validation consist of pre-defined and pre-approved protocols to assess the defined parameters of a specified test procedure, or production method. Qualification provides documented data that assesses the suitability of a specified test procedure, or production method for its intended purpose, and validation provides documented evidence that a test procedure, or production method is suitable (within pre-defined parameters) for its intended purpose. Validation reports are the output of an executed validation protocol. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CERUS CORPORATION NOVA BIOMEDICAL CORPORATION Quality Agreement
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Related to Qualification and Validation

  • Qualification and Good Standing Each Loan Party is qualified to do business and in good standing in every jurisdiction where its assets are located and wherever necessary to carry out its business and operations, except in jurisdictions where the failure to be so qualified or in good standing has not had and will not have a Material Adverse Effect.

  • Election and Term of Office The officers of the Company shall be elected annually by the Board of Managers at the first meeting of the Board of Managers held after the annual meeting of Members. If the election of officers shall not be held at such meeting, such election shall be held as soon thereafter as convenient. Vacancies may be filled or new offices created and filled at any meeting of the Board of Managers. Each officer shall hold office until his successor shall have been duly elected and shall have qualified or until his death or until he shall resign or shall have been removed in the manner hereinafter provided.

  • Qualification to Do Business Each of the Company and its Subsidiaries is duly qualified to do business as a foreign corporation, limited liability company or partnership (as the case may be) and is in good standing or similar concept in every jurisdiction in which the character of the properties owned or leased by it or the nature of the business conducted by it makes such qualification necessary, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Company Material Adverse Effect.

  • Qualifications for Voting To be entitled to vote at any meeting of Holders a Person shall (a) be a Holder of one or more Notes on the record date pertaining to such meeting or (b) be a Person appointed by an instrument in writing as proxy by a Holder of one or more Notes on the record date pertaining to such meeting. The only Persons who shall be entitled to be present or to speak at any meeting of Holders shall be the Persons entitled to vote at such meeting and their counsel and any representatives of the Trustee and its counsel and any representatives of the Company and its counsel.

  • Due Qualification and Good Standing The Borrower is in good standing in the State of Delaware. The Borrower is duly qualified to do business and, to the extent applicable, is in good standing in each other jurisdiction in which the nature of its business, assets and properties, including the performance of its obligations under this Agreement, the other Facility Documents to which it is a party and its Constituent Documents, requires such qualification, except where the failure to be so qualified or in good standing could not reasonably be expected to have a Material Adverse Effect.

  • Organization and Good Standing; Qualification The Seller has been duly organized and is validly existing as a limited liability company in good standing under the laws of the State of Delaware, with the power and authority to own or lease its properties and to conduct its activities as such properties are currently owned or leased and such activities are currently conducted.

  • Election and Tenure The President, the Treasurer and the Secretary, and such other officers as the Trustees may in their discretion from time to time elect shall each be elected by the Trustees to serve until his or her successor is elected or qualified, or until he or she sooner dies, resigns, is removed or becomes disqualified. Each officer shall hold office and each agent shall retain authority at the pleasure of the Trustees.

  • Qualification; Compliance 19 (d) Liabilities . . . . . . . . . . . . . . . . . . . . 19 (e) Welfare Plans . . . . . . . . . . . . . . . . . . . 20 (f) Documents made Available . . . . . . . . . . . . . 20 (g) Payments Resulting from Merger . . . . . . . . . . 20 (h) Labor Agreements . . . . . . . . . . . . . . . . . 21 Section 4.11

  • Number, Election and Term of Office The Board of Directors shall consist of not fewer than one (1) or more than five (5) persons, or such other number as is fixed from time to time by the vote of a majority of the entire Board of Directors or by action of the Sole Member or Members of the Company. Directors shall be elected at the annual meeting of the Sole Member or Members for a term of one year, and shall hold office until their successors are elected, or until their earlier death, resignation or removal as provided in this Agreement.

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