Contract Manufacturer. Promptly following the Effective Date, but in no event later than ninety (90) days after the Effective Date, Astaria shall enter into an agreement with Viant Medical, or another party reasonably acceptable to Cytonics (the “Contract Manufacturer”), such acceptance by Cytonics will not be unreasonably withheld, pursuant to which the Contract Manufacturer will perform or contract sub-suppliers to perform all ordering, manufacturing, assembly, packaging, sterilization, testing, warehousing, and order fulfillment functions (the “Contract Manufacturing”) with respect to the APIC System (the “Contract Manufacturer Agreement”). Cytonics shall be a party to the Contract Manufacturer Agreement and will remain the beneficiary of the Contract Manufacturing Agreement should this agreement terminate for any reason. Astaria shall negotiate the Contract Manufacturer Agreement with the Contract Manufacturer in consultation with Cytonics, and Astaria shall not execute any Contract Manufacturer Agreement without the prior written approval of Cytonics. Astaria shall cause the Contract Manufacturer Agreement to allow Cytonics full access to information (both hard copy and on-line access) relating to the Contract Manufacturing performed by the Contract Manufacturer under the Contract Manufacturer Agreement. Astaria shall pay all fees charged by the Contract Manufacturer under the Contract Manufacturer Agreement.
Contract Manufacturer. Subject to the terms and conditions of this Agreement, each Party shall have the right to Manufacture the Compounds and/or Products under this Agreement through a Third Party contract manufacturer, provided that its agreement with such Third Party shall (i) permit such Party to transfer the manufacturing process used by such Third Party to the other Party; and (ii) require such Third Party to transfer to such Party engaging such Third Party contractor manufacture all records pertaining to such Manufacturing activities to the extent required, so that such Party may satisfy its obligations under Section 7.4.
Contract Manufacturer. An organization contracted to perform one or several of these activities manufacturing, laboratory testing, fill/finish, labelling, packaging, storage, distribution, or other services and/or processes related to a Product.
Contract Manufacturer. Buyer may use one or more third party contract manufacturers (“CM”) for the manufacture of its products. The Goods purchased under the Agreement may be used by such CM in the manufacture of such products for Buyer. Accordingly Seller agrees that such CM may purchase Goods under the terms and conditions of the Agreement in such situations upon the prior written consent of Buyer. Seller on its behalf and on behalf of its Affiliates agrees that Buyer and Buyer Affiliates shall be a third party beneficiary under any contract between Seller and such CM and that all terms of the Agreement shall be incorporated into any contract between Seller and such CM.
Contract Manufacturer. 25.2.1 All sites of contract manufacturers and the name of the contract manufacturer must have been reviewed and approved by WHO PQP and/or the relevant SRA and/or the Expert Review Panel.
Contract Manufacturer. An organization contracted to perform manufacturing, laboratory testing, fill/finish, labeling, packaging, storage, distribution, or other services and/or processes related to a product. Nonconforming Event (Deviation): An occurrence that is a departure from documented procedures or specifications. Any deviation from established procedures are documented and explained. Critical deviations must be investigated, and the investigation and conclusions documented.
Contract Manufacturer. As more fully described in the Business Description, Biovax shall serve as a non-exclusive contract manufacturer to manufacture anti-cancer vaccines for Biovest as and when ordered and pursuant to required specifications submitted in writing by Biovest and accepted by Biovax. All vaccines manufactured by Biovax for Biovest shall be paid for at a manufactured cost equal to the fully burdened manufactured cost plus 20%. Biovax’s fully burdened cost includes all third party and overhead expenses, such as wages and salaries, lease payments, utilities, purchases of manufacturing materials, maintenance and repairs to equipment and leasehold, amortization, and other expenditures necessary or appropriate to operate the Lease Premises currently accrued, using the same methodology as currently used in Biovest financial accounting. Fully burdened costs do not include capital expenditures such as purchases of equipment and partially completed vaccines, expansion of facilities, leasehold improvements, and employee training. Biovest shall have the right to inspect and audit the calculation of full burdened manufactured cost upon reasonable notice to Biovax. Invoices shall be paid within 30 days after invoice. In addition to the foregoing amounts, for so long as Biovest requires vaccines to be manufactured by Biovax for the Biovest clinical trial, Biovest shall pay to Biovax an amount equal to $250,000 per annum. Nothing herein shall prohibit Biovax from engaging in other manufacturing activities utilizing the Equipment, Leasehold and Worcester employees; provided, that in the event of any such other activities, expenses shall be appropriately apportioned to determine the fully burdened costs of the vaccines manufactured for Biovest.
Contract Manufacturer. During the Term of this Agreement, RK shall manufacture and test the Products (or cause the Products to be manufactured and tested) in accordance with the Manufacturing Specifications. During this time, RK will maintain manufacturing records in accordance with best industry standards. All Inventory and equipment required in connection with such manufacture and testing will be acquired or supplied by RK pursuant to the Manufacturing Specifications. RK shall be responsible for the identification, evaluation, selection and performance of any outsourced third party manufacturer, engaged or used by RK in connection with Product manufacturing and testing. Within thirty (30) days of the Effective Date of this Agreement, RK shall present Raymarine with a minimum three (3) third party manufacturers that have been approved by RK for this purpose. Raymarine shall review and audit such proposed third party manufacturers and shall, within (30) days from date of such initial submission by RK, either confirm one such third party manufacturer, or advise RK in writing that Raymarine has not confirmed any such proposed third party manufacturer, in which case, RK shall propose such additional third party manufacturers to Raymarine until Raymarine so confirms and approves one (hereinafter, the “Contract Manufacturer”). RK shall be solely responsible for the Contract Manufacturer’s performance. Following such appointment, RK may replace the Contract Manufacturer, but only with the prior written consent of Raymarine, which consent shall not be unreasonably withheld.
Contract Manufacturer. In the case of an Inability to Supply that Hospira is unable to resolve in whole or in major part within [**] days, or if Hospira notifies Genzyme that it will not be able to alleviate such Inability to Supply within such [**] day period, Genzyme may, upon notice to Hospira, terminate the relevant Project SOW, and Genzyme may contract with a Third Party contract manufacturer to supply the Product.
