Specifications and Quality Clause Samples
The "Specifications and Quality" clause defines the standards and requirements that goods or services provided under the contract must meet. It typically outlines the technical specifications, performance criteria, and quality benchmarks that the supplier is obligated to adhere to, and may reference industry standards or detailed documentation. This clause ensures that the delivered products or services are fit for their intended purpose and meet the buyer's expectations, thereby reducing the risk of disputes over quality and clarifying the parties' obligations.
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.
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.
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.
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 ▇▇▇ ▇▇▇▇ 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.
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.
Specifications and Quality