Validations and Qualifications Sample Clauses

Validations and Qualifications. BMS will perform, ***, process and cleaning validation, analytical methods validation, installation/operating qualification, and calibration of all equipment and Facilities utilized in the manufacture, packaging, labeling, testing, *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. storing, and release of finished Product in accordance with all Laws. The Parties acknowledge and agree that BMS will ***. The Company will have right to review the results thereof during an Audit or in conjunction with a new process or equipment. In general, BMS will, at all times in the performance of its obligations hereunder, comply with its standard operating procedures for the Product and will make copies of such standard operating procedures available to the Company for review during Company Audits permitted hereunder.
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Validations and Qualifications. PBM shall concurrently perform process and cleaning validation, analytical methods validation, and installation/operating qualification, and calibration of all equipment and facilities utilized in the manufacture, packaging, testing, storing, and release of POC Rapid Assays. Such validations, qualifications, and calibrations are to be in accordance with all current regulations determined by the responsible authorities (in particular, without limitation, the regulations of the FDA and any European Community or European Union directives relating to medical devices and in vitro medical devices), and PBM shall, through effective control procedures, ensure all such validations, qualifications, and calibrations will be current. In general, PBM shall, at all times in the performance of its obligations hereunder, comply with its standard operating procedures for the POC Rapid Assays
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Validations and Qualifications. Stellar or its Approved Manufacturer shall perform process and cleaning validation, analytical methods validation, and installation/operating qualification, and calibration of all equipment and facilities utilized in the manufacture, packaging, testing, storing, and release of finished Product. Such validations, qualifications, and calibrations are to be in accordance with all current FDA regulations, and Stellar shall, through effective control procedures, ensure all such validations, qualifications, and calibrations will be current. Upon reasonable advance notice and arrangement with Stellar, Xxxxxx will have the right to observe the validation process and review the results thereof during the annual Audit or in conjunction with the implementation of a new process or the use of new equipment. In general, Stellar shall, at all times in the performance of its obligations hereunder, comply with its standard operating procedures for the Product and will make copies of such standard operating procedures available to Xxxxxx for review.
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Validations and Qualifications. Supplier will perform process and cleaning validation, analytical methods validation, and installation/operating qualification, and calibration of all equipment and facilities utilized in the manufacture, packaging, testing, storing, and release of finished Product. Such validations, qualifications, and calibrations are to be in accordance with all current FDA regulations, and Supplier shall, through effective control procedures, ensure all such validations, qualifications, and calibrations will be current. In general, Supplier will, at all times in the performance of its obligations hereunder, comply with its standard operating procedures for the Product. Schedule 7.4(b) attached hereto contains certain process validation activities that are additional requirements. Supplier agrees to perform these additional process validation activities and Buyer agrees to compensate Supplier for the performance of those additional process validation activities as provided in Schedule 7.4(b).
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Related to Validations and Qualifications

  • Organization and Qualifications Customer and each of its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is engaged and (iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is engaged in business and is required to be so qualified.

  • Formation and Qualification (a) Each Borrower is duly incorporated and in good standing under the laws of the state listed on Schedule 5.2(a) and is qualified to do business and is in good standing in the states listed on Schedule 5.2(a) which constitute all states in which qualification and good standing are necessary for such Borrower to conduct its business and own its property and where the failure to so qualify could reasonably be expected to have a Material Adverse Effect on such Borrower. Each Borrower has delivered to Agent true and complete copies of its certificate of incorporation and by-laws and will promptly notify Agent of any amendment or changes thereto.

  • Diversification and Qualification 6.1. The Fund will invest the assets of each Designated Portfolio in such a manner as to ensure that the Contracts will be treated as annuity or life insurance contracts, whichever is appropriate, under the Code and the regulations issued thereunder (or any successor provisions). Without limiting the scope of the foregoing, the Fund will, with respect to each Designated Portfolio, comply with Section 817(h) of the Code and Treasury Regulation §1.817-5, and any Treasury interpretations thereof, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts, and any amendments or other modifications or successor provisions to such Section or Regulations. In the event of a breach of this Article VI by the Fund, it will take all reasonable steps (a) to notify the Company of such breach and (b) to adequately diversify the affected Designated Portfolio so as to achieve compliance within the grace period afforded by Treasury Regulation §1.817-5.

  • Organization and Qualification The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

  • Number, Tenure and Qualifications The number of managers of the Company shall be not less than one (1) nor more than ten (10), but may be increased by amendment of this LLC Agreement by the Members. Each manager shall hold office for the term of which he is elected or until his successor shall have been elected and qualifies for the office, whichever period is longer. Managers need not be residents of the state of formation nor need they be the holder of any Percentage Ownership of the Company.

  • Number and Qualifications The number of Managers of the Company shall not be less than three nor more than five, as may be determined by the Member from time to time, but no decrease in the number of Managers shall have the effect of shortening the term of any incumbent Manager.

  • Existence and Qualification The Contracting Party is an Oklahoma municipality, validly existing and in good standing under the laws of the State of Oklahoma, and the Contracting Party has all requisite power and authority to own, operate and lease its properties and to carry on its business as presently conducted.

  • Corporate Organization and Qualification Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Buyer has the requisite corporate power and authority to own or lease all of its properties and assets and to carry on its business as it is now being conducted.

  • Incorporation and Qualification The Company has been duly organized and is validly existing as a Corporation and in good standing under the laws of the State of Colorado with the requisite corporate power and authority to own and use its properties and assets and to carry on its business as currently conducted.

  • Maintenance of Existence and Qualifications Each Restricted Person will maintain and preserve its existence and its rights and franchises in full force and effect and will qualify to do business in all states or jurisdictions where required by applicable Law, except where the failure so to qualify will not cause a Material Adverse Change.

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