Contract Manufacturer. Promptly following the Effective Date, but in no event later than ninety (90) days after the Effective Date, A2Mcyte shall enter into an agreement with Advanced Biomedical Concepts, LLC, 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”). For the avoidance of doubt, neither Cytonics nor any of its Affiliates shall be a party to the Contract Manufacturer Agreement. A2Mcyte shall negotiate the Contract Manufacturer Agreement with the Contract Manufacturer in consultation with Cytonics, and A2Mcyte shall not execute any Contract Manufacturer Agreement without the prior written approval of Cytonics. A2Mcyte 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. A2Mcyte shall pay all fees charged by the Contract Manufacturer under the Contract Manufacturer Agreement.
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. 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. 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. Oncolytics may meet its obligations to supply the Licensed Product to Licensee hereunder or under the Supply Agreement through subcontracting with Third Parties jointly selected, qualified and validated by Licensee and Oncolytics (each, a “Contract Manufacturer”), subject to the following requirements and Clause 4.10:
Contract Manufacturer. If either Party wishes to contract manufacture of Active Drug Substance and/or Products to the other Party’s Third Party Manufacturer in the Territory, the other Party shall, [***],reasonably cooperate with and assist such requesting Party, to the extent reasonably requested in arranging such Third Party Manufacturer to manufacture the Active Drug Substance and/or the Product for the requesting Party, provided that such efforts and contract do not interfere with the supply of Active Drug Substance and/or Products to the other Party.
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.
Contract Manufacturer. Without limiting Aegis’ obligation to comply with the terms of this Supply Agreement, Aegis shall have the right at any time to satisfy its supply obligations to Opiant hereunder either in whole or in part through arrangements with Contract Manufacturers; provided that (a) Aegis shall give Opiant prior written notice of any such arrangement with a Contract Manufacturer with sufficient time to permit Opiant to evaluate the implications of any such arrangement on the existing or pending development or approvals for Materials or Products; (b) any arrangement made or entered into after the Effective Date with a Contract Manufacturer that will result in a delay in Aegis’ or such Contract Manufacturer’s ability to meet Opiant’s delivery requirements for Materials pursuant to any Orders made pursuant to Article 5.1 shall require the prior written consent of Opiant (including delay due to modifications or new approvals required in connection with such new Contract Manufacturer); (c) Aegis shall otherwise remain responsible for all of its obligations set forth herein; and (d) Aegis shall promptly notify Opiant upon Aegis becoming aware of any (i) any failure or reasonably expected failure by a Contract Manufacturer to supply Materials, or (ii) performance by a Contract Manufacturer in a manner that would result in Aegis not being in material compliance with this Supply Agreement. The Parties acknowledge that as of the Effective Date, **** and **** are acting as the only Contract Manufacturers, and Opiant has accepted **** and **** as Contract Manufacturers. Aegis shall require its Contract Manufacturer(s) to comply in all material respects with the requirements set forth in this Supply Agreement, including the establishment and deployment of regular and as-needed inspections of the facilities of such Contract Manufacturer(s) by Opiant and the execution of regular and as-needed audits of such Contract Manufacturer(s). Aegis shall not amend those agreements with Contract Manufacturer(s) to the extent they apply to the Territory in a manner inconsistent or in conflict with the terms of this Supply Agreement nor terminate them to the extent they apply to the Territory without prior written consent of Opiant, not to be unreasonably withheld. Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has...
Contract Manufacturer. The term "Contract Manufacturer" means a Person Buyer designates to manufacture the Delsym Product on its behalf pursuant to Section 2.3 of the License Agreement.
