Specifications and Quality Sample Clauses

Specifications and Quality. Except as specifically contemplated in this Section 6, the Specifications will not be revised without the mutual prior written consent of the parties. Mallinckrodt will notify Voyager at least twelve (12) months in advance (unless a lesser time to implement any change is dictated by law) of any and all material changes in its production, testing or packaging procedures in the DMF documented process as required by FDA "Guidelines for Drug Master Files" Section VIIA and Note for Guidance on the European Drug Master File procedure, CPMP/QWP/227/02 or in the Specifications which may be suggested or mandated by a Competent Authority. The parties acknowledge that the purpose of the immediately preceding sentence is to allow Voyager a reasonable amount of time to receive appropriate regulatory approval prior to Mallinckrodt implementing a significant change to its DMF. In the event of a proposed change in the Specifications suggested or mandated by a Competent Authority, the parties will work together in good faith to develop revised Specifications that meet all changes suggested or mandated by the Competent Authority, but if any such change is mandated by such Competent Authority or required by applicable laws, rules or regulations, Mallinckrodt shall be entitled to make such changes as and when required. In the event of a proposed change in the DMF or Specifications that renders Mallinckrodt unable to supply Product in accordance with the terms of this Agreement, Voyager may terminate this Agreement effective upon written notice to Mallinckrodt. In the event of any conflict or inconsistency between the terms of any quality agreement or similar agreement that may be entered into by the parties, on the one hand, and the terms and conditions of this Agreement, on the other hand, the latter shall prevail in all cases.
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Specifications and Quality. 7.1 BIOTIUM shall manufacture and package and supply all Products in accordance with and to meet the Specifications.
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Specifications and Quality a) Specifications: Each Product delivered pursuant to this Agreement shall comply with the Purchase Specifications. Certificates of Analysis showing size and description, lot or batch number, date of manufacture, site or plant of manufacture, and the specifics of the analysis of all Product properties requested by Cangene, will be provided by Company with each lot of Product. Whenever reasonably possible, shipments (to all centers) shall consist of a single manufacturing lot in pallet quantities. All Products delivered hereunder shall be delivered within [**] weeks of the date of manufacture, unless otherwise approved by Cangene.
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Specifications and Quality. Specifications for the release of Compound Candidates, Product Candidates, Licensed Compounds and Licensed Products in bulk or finished form will be set forth in the R&D Plan (such specifications, as amended by mutual agreement of the Parties from time to time, the “Specifications”). The Parties will use good faith reasonable efforts to enter into a clinical pharmaceutical product quality agreement within sixty (60) days of the Effective Date (as amended from time to time, the “Clinical Quality Agreement”). Assembly shall be responsible for ensuring that Compound Candidates, Product Candidates, Licensed Compounds and Licensed Products it or any CMO supplies hereunder to Allergan or its designee are manufactured and stored in accordance with their applicable Specifications, this Agreement and the Clinical Quality Agreement. The Clinical Quality Agreement will be updated by mutual agreement of the Parties to reflect additional relevant information resulting from ongoing Development activities under this Agreement.
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Specifications and Quality. 3.1 The Supplier shall supply the Goods and/or Services in accordance with the specifications and other requirements described in or attached to the Purchase Order.
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Specifications and Quality 
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Related to Specifications and Quality

  • Existence and Qualification; Power; Compliance With Laws Parent and each of the Borrowers are duly formed, validly existing and in good standing under the Laws of its jurisdiction of formation. Parent and each of the Borrowers are duly qualified or registered to transact business and is in good standing in each other jurisdiction in which the conduct of its business or the ownership or leasing of its Properties makes such qualification or registration necessary, except where the failure so to qualify or register and to be in good standing would not constitute a Material Adverse Effect. Parent and each of the Borrowers have all requisite corporate or partnership power (as applicable) and authority to conduct their respective business, to own and lease their respective Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. All outstanding shares of capital stock of Parent and each of the Borrowers are duly authorized, validly issued, fully paid, and non-assessable and no holder thereof has any enforceable right of rescission under any applicable state or federal securities Laws. Parent and each of the Borrowers are in compliance with all Laws and other legal requirements applicable to their respective business, have obtained all authorizations, consents, approvals, orders, licenses and permits from, and have accomplished all filings, registrations and qualifications with, or obtained exemptions from any of the foregoing from, any Governmental Agency that are necessary for the transaction of their business, except where the failure so to comply, file, register, qualify or obtain exemptions does not constitute a Material Adverse Effect.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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