Manufacturing of Products. Subject to Article 3 of this Agreement, the Manufacturer shall deliver the Products to the Company or such other third party as may be directed by the Company to be further manufactured into Tablets which the Company will thereafter cause to be delivered to the Manufacturer for Packaging in accordance with the Packaging Specifications. In accordance with Section 5.1 of this Agreement, Manufacturer shall perform all necessary testing of the Products prior to their release. Upon release by Manufacturer of Product meeting the Product Specifications as evidenced by the Certificate of Analysis and Certificate of Conformance delivered to Company, nothing shall excuse the Company of its obligation to accept Products or its payment obligation, except in such instances where there is a bona fide dispute as to whether the Products met the Product Specifications at the time of their release, in which case such dispute will be resolved in accordance with Section 5.4 hereof.
Manufacturing of Products. Subject to the terms and conditions of this Agreement, IAC shall procure, directly or indirectly, certain Third Party Components (as identified on the Statement of Work and maintained in Arena), manufacture, assemble, and test Products which Sonos and/or its Affiliates may order from IAC, respectively. The various Products shall be manufactured by IAC according to the respective Statement of Work, as set forth in an applicable Exhibit A. IAC agrees to supply Product(s) in conformance with the applicable Statement of Work for the duration of this Agreement. IAC agrees to build and ship Product Units directly to a Sonos Destination. IAC will handle all necessary fulfillment, external packaging, customs clearance and shipping procedures necessary to deliver the Product Unit(s) directly to the designated Sonos Destination, anywhere in the world, in accordance with the shipping terms specified in Section 6.5, or any other terms that may be mutually agreed upon between the Parties in writing.
Manufacturing of Products. (a) Buyer may, from time to time, request changes to the Specifications. Seller shall use commercially reasonable efforts to accommodate the requested changes. If changes result in a change in the cost or in the time required to manufacture such Products, an adjustment to the prices and/or lead times (if any) listed on Exhibit C will be made. Any adjustment to prices or lead times shall be in writing. No changes shall be implemented and become a part of the Agreement until ninety (90) days following Seller's and Buyer's mutual agreement of the modifications and price changes, if any.
Manufacturing of Products. Establish its own manufacturing facility (or outsource to a third party) for the manufacture of the Products according to all regulatory requirements of the Territory in which the Products will be distributed (i.e., U.S. FDA Quality System Regulations, European Medical Device Directives, or Canadian Medical Device Requirements (CMDCAS)) utilizing the documents provided by CystoMedix pursuant to Section 3(c) below. Uroplasty will own the manufacturing processes and documentation it develops and uses for the Products.
Manufacturing of Products. The Supplier commits to produce the Products in accordance with the Technical Agreement
Manufacturing of Products. Nortel shall manufacture and shall coordinate with such of its Affiliates or subcontractors as necessary, and Avici shall order the manufacture of, Products by Nortel, in accordance with the terms and conditions of this Agreement. Nortel shall deliver to Avici's specified location only that quantity of Products specified in Avici's Purchase Orders at the Prices set forth herein. All applicable transportation and insurance costs incurred by Nortel in connection with the Delivery of the Products to Avici shall be for the account of Avici.
Manufacturing of Products. After the Closing Date and for the term of this Agreement, IFM shall continue to manufacture the Products for Horizon in accordance with the terms of this Agreement. IFM will manufacture the Products exclusively for Horizon for the term of the Agreement. Horizon agrees to purchase Products exclusively from IFM during the term of this Agreement except as otherwise provided herein.
Manufacturing of Products. During the Term, subject to the provisions of Section 6.2, Inverness Japan shall be responsible for (i) the manufacture, safety testing, quality, packaging and labeling of the Products, (ii) any product liability arising from the manufacture of the Products, and (iii) all other activities identified in Exhibit A. The Products shall be manufactured at the Manufacturing Facility using the Equipment owned by Buyer and the services of the Japanese Employees in accordance with the provisions of the Master Secondment Agreement. The Products shall be manufactured at all times in full compliance with Applicable Laws, cGMPs, Product Specifications and any other applicable requirements of the Regulatory Authorities and shall maintain all records as are necessary and appropriate to demonstrate full compliance with the foregoing.
Manufacturing of Products. Spectral shall, at its sole cost and expense, manufacture, or have manufactured, the Products.
Manufacturing of Products. ACCEPTOR assumes full responsibility for the manufacture, bulk packaging and In-Process Control (IPC) of the PRODUCT even if these activities are partially performed by a contractor. Manufacture, IPC. analytical testing, packaging and shipment of the PRODUCT are carried out according to ACCEPTOR and MAGENTA approved documents. Batch Manufacturing and Packaging Records ACCEPTOR assures that manufacture and packaging of the produces are carried out according to the mutually agreed manufacturing procedures and packaging instructions (see Enclosure C). ACCEPTOR will submit the master batch record to MAGENTA for approval before the first start of manufacture of PRODUCTS, or before an approved change is implemented. Any change to those documents should be managed as described in the Change control section of this Quality Agreement (or according to the deviation section in case of urgent modification needs). ACCEPTOR compiles and archives clear structured batch documentation for each batch of the products. The manufacturing batch records as well as testing documentation kept by ACCEPTOR have to comply with the applicable GMP guidelines. ACCEPTOR assures that upon special request from MAGENT A, the following documents will be provided as copies within [***] working days to MAGENTA: [***] ACCEPTOR and/or its approved contractors will prepare for each batch the complete batch documentation which is necessary for the manufacture and release of the PRODUCT batches in accordance with applicable cGMP. The complete batch manufacturing record must include the following information: [***] The batch packaging record provides in addition to above information the following: [***]
