Contract Manufacturer. Promptly following the Effective Date, but in no event later than ninety (90) days after the Effective Date, CMH shall enter into an agreement with a contract manufacturer deemed 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 the primary party to the Contract Manufacturer Agreement, however Cytonics will be named the beneficiary if the Contract Manufacturing Agreement should this agreement terminate pursuant to Article 16. CMH shall negotiate the Contract Manufacturer Agreement with the Contract Manufacturer in consultation with Cytonics, and CMH shall not execute any Contract Manufacturer Agreement without the prior written approval of Cytonics. CMH 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. CMH 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. As more fully described in the License Agreement, AutovaxID shall serve as a non-exclusive contract manufacturer to manufacture Autovax Instruments for Biovest to be used by Biovest for internal manufacturing purposes, including but not limited to producing anti-cancer vaccine for clinical trial or commercial sale and to produce other cell products including contract manufacturing of any description and for re-sale to customers outside North America, provided Biovest cannot purchase Autovax Instruments for resale to customers in or to be used in North America. Biovest shall have no minimum purchase requirements and all such purchases shall be as and when required by Biovest and shall be at the specifications submitted in writing by Biovest and accepted by AutovaxID. All Autovax Instruments manufactured by AutovaxID for Biovest shall be paid for at fair market value (which shall be no less than fully burdened manufactured cost). AutovaxID’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 AutovaxID. Invoices shall be paid within 30 days after invoice. Nothing herein shall prohibit Biovest from purchasing Autovax Instruments from other manufacturing sources outside of North America.
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:
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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. Each Party shall have the right to Manufacture the mRNA Constructs and Products under this Agreement through a CMO, provided that its agreement with such CMO shall
(i) permit such Party to transfer the manufacturing process used by such CMO to the other Party, in case and to the extent such technology transfer is required under this Agreement; and
(ii) require such CMO to transfer to such Party engaging such CMO all records pertaining to such Manufacturing activities, so that such Party may satisfy its obligations under Section 6.5.
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.
