Scope of Manufacturing Services. During the term of this Agreement, upon the placement of binding and irrevocable Purchase Orders for Products by the Customer in accordance with Article 6 (Order Process) and subject to the forecast and capacity allocation process described in Article 4 (Planning and Capacity Allocation), NXP shall (a) produce or procure from Third Party Providers silicon wafers and all other necessary raw materials for the production of Products ordered by the Customer; (b) manufacture such Products; and (c) deliver the resulting finished Products to the Customer in accordance with the terms and conditions of this Agreement (the services in clauses (a), (b) and (c), collectively, the “Manufacturing Services”). The Parties agree and acknowledge that this Agreement contemplates a non-exclusive relationship, and that the Customer shall have the right at any time to develop second sources of supply for some or all of the Products, or to transition the manufacture of some or all of the Products entirely to one or more third-party contract manufacturers.
Scope of Manufacturing Services. (A.) In the U.S., Cognate will provide Manufacturing Services for the production of DCVax®-L products for various cancers, including brain cancer (the “DCVax®-L Product(s)”). Such Manufacturing Services, together with related Ancillary Services, will comprise the services necessary for the production and release of the DCVax®-L Products for administration to human patients [*]. The Manufacturing Services do not include any services after product release at Cognate’s cGMP manufacturing facility and delivery by Cognate to the shipping company.
(B.) Outside the U.S., under the Prior Services Agreement Cognate has been providing extensive and ongoing technology transfer, technical support and general management and oversight of third party providers and manufacturers, and the services required by NW Bio have been growing and expanding substantially. Following the Effective Date of this Agreement, such services relating to third parties will be provided under the separate agreements for Ancillary Services. [*] [*] Confidential treatment required; certain information omitted and filed separately with the SEC.
Scope of Manufacturing Services. (A.) In the U.S., Cognate will provide Manufacturing Services for the production of DCVax®-Direct products for various solid tumor cancers, (the “DCVax®-Direct Product(s)”). Such Manufacturing Services, together with related Ancillary Services, will comprise the services necessary for the production and release of the DCVax®-Direct Products for administration to human patients (including, without limitation, materials management, quarantined inventory, quality control, quality assurance, sterility testing, potency assays and lot release). The Manufacturing Services do not include any services after product release at Cognate’s cGMP manufacturing facility and delivery by Cognate to the shipping company.
(B.) Outside the U.S., under the Prior Services Agreement Cognate has been providing extensive and ongoing technology transfer, technical support and general management and oversight of third party providers and manufacturers, and the services required by NW Bio have been growing and expanding substantially. Following the Effective Date of this Agreement, such services relating to third parties will be provided under the separate agreements for Ancillary Services. [*]. The amounts to be billed by Cognate for such direct Manufacturing Services outside the U.S. will be jointly agreed by the parties based upon market factors and costs, and are anticipated to be substantially higher than in the U.S., particularly with respect to direct and indirect personnel costs. This Agreement will include (and will be further amended and restated as needed to include) direct Manufacturing Services outside the U.S. as soon as Cognate is ready to begin preparations for and implementation of such Services. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
Scope of Manufacturing Services. In the U.S., Cognate will provide manufacturing and related services for the production of NWBT’s DCVax® products including, without limitation, DCVax®-L, DCVax®-Direct and DCVax®-Prostate (collectively, the “DCVax® Products”). Such manufacturing and related services shall include both the manufacturing of the DCVax® Products and the related services necessary for release of the DCVax® Products for administration to human patients (including, without limitation, materials management, quarantined inventory, quality control, quality assurance, sterility testing, potency assays and lot release)(the foregoing, collectively, “the Manufacturing Services”). The Manufacturing Services do not include any services after product release at Cognate’s cGMP manufacturing facility and delivery by Cognate to the shipping company. Outside the U.S., Cognate will either perform the Manufacturing Services or oversee and manage the performance of the Manufacturing Services by third parties, provided that NWBT pays for such services in accordance with Section 2 hereof.
