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. 7.2 Biotium shall supply a Certificate of Analysis (C of A) for the Products with each shipment of such Products confirming and certifying that the Products meet the Specifications. MSDS shall be readily available from Biotium upon request. If LICENSEE does not receive such C of A for any Product with the shipment thereof, such C of A shall be readily available from BIOTIUM upon request. LICENSEE shall be responsible for distribution of information contained in the MSDS to its customers and employees, and if such information is legally required to accompany materials transferred by LICENSEE. BIOTIUM shall also provide LICENSEE with Agency certification, for those countries in which the applicable Agency is in the practice of requiring any such certifications. 7.3 Although there may be parameters other than those set forth in this AGREEMENT that may determine the suitability of the Biotium Products for incorporation into LICENSEE’s products and the use thereof in the FIELD OF USE, only the Specifications for the Biotium Products that are specifically set forth in this AGREEMENT, as may be amended by written agreement of the Parties, shall be used to determine acceptance by LICENSEE of the Biotium Products with respect to incoming inspection under Article 8 below. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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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. 3.2 The Supplier undertakes to supply the Goods and/or Services using suitably experienced personnel who will carry out their duties with due diligence and in accordance with good industry practice, using materials of good construction and adequate strength which are free of defects in design, materials and workmanship. 3.3 The Goods and/or Services shall comply with the express terms of the Purchase Order and these Terms and Conditions and with the implied conditions, warranties and terms contained in the Sale of Goods Xxx 0000 and related statutes and with any specification of the British Standards Institution (or equivalent) which is relevant to the Goods and/or Services at the time of Contract. 3.4 The Supplier shall comply with all applicable statutes, regulations and/or legal requirements concerning the manufacture, packaging, packing, sale and delivery of the Goods and/or the performance of the Services. 3.5 With the exception of Goods made to Buyer’s design or instructions Supplier shall warrant that neither the Goods nor use of them will infringe any patent, registered design, trademark, copyright or other protected right and undertake to indemnify Buyer against all claims, losses, damages, costs (including legal costs), expenses and liabilities of every kind for, or arising out of, any alleged infringement of any such right.
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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 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 
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Related to Specifications and Quality

  • Existence and Qualification; Power; Compliance With Laws Borrower is a corporation duly formed, validly existing and in good standing under the Laws of the State of California. Borrower is duly qualified or registered to transact business and is in good standing in the State of California, and 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 could not reasonably be expected to have a Material Adverse Effect. Borrower has all requisite power and authority to conduct its business, to own and lease its Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. The chief executive offices of Borrower are located in San Dimas, California. All outstanding capital stock of Borrower is 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 or other Laws. Borrower is in compliance with all Laws and other legal requirements applicable to its business, has obtained all authorizations, consents, approvals, orders, licenses and permits from, and has 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 its business, except where the failure so to comply with Laws and other legal requirements applicable to its business, obtain authorizations, etc., file, register, qualify or obtain exemptions could not reasonably be expected to have a Material Adverse Effect.

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • 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. (b) The only Subsidiaries of each Borrower are listed on Schedule 5.2(b).

  • 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.

  • 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. 6.2. The Fund represents that each Designated Portfolio is or will be qualified as a Regulated Investment Company under Subchapter M of the Code, and that it will make every effort to maintain such qualification (under Subchapter M or any successor or similar provisions) and that it will notify the Company immediately upon having a reasonable basis for believing that a Designated Portfolio has ceased to so qualify or that it might not so qualify in the future. 6.3. The Company represents that the Contracts are currently, and at the time of issuance shall be, treated as life insurance or annuity insurance contracts, under applicable provisions of the Code, and that it will make every effort to maintain such treatment, and that it will notify the Fund and the Underwriter immediately upon having a reasonable basis for believing the Contracts have ceased to be so treated or that they might not be so treated in the future. The Company agrees that any prospectus offering a contract that is a "modified endowment contract" as that term is defined in Section 7702A of the Code (or any successor or similar provision), shall identify such contract as a modified endowment contract.

  • 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.

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