Manufacturing Site. New Carotid Stent Delivery System catalogs with 57 cm length assembly and packaging will be performed at Cordis de Mexico. Sterilization will be performed at Steris Isomedix Inc. sterilization facilities in El Paso, Texas. FUNCTIONAL REPRESENTATIVES: Team members, roles, and responsibilities are subject to change at Cordis’ sole discretion. Team Member Roles Responsibilities OETS (Sustaining) / Operations Xxxxx Xxxxxx MEST Director Overall Project Leadership. Xxxxxx Xxxxxx MEST (Value Engineering) Manager Project Manager. Provide input for this D&D plan. Xxxxx Xxxxxx Xxxx Lead MEST (Value Engineering) Engineer (Project Leader) Project leader. Plan and execute key activities as per this D&D plan. Xxxxx X. Xxxxxxxx MIST (Value Engineering) Engineer Provide project support. Xxxxxx Xxxxxxxx MEST (Value Engineering) Engineer Provide project support. Xxxx Xxxxxxxx MEST (Value Engineering /Contractor) – Packaging Engineer. Provide project support in the area of packaging. Plan and execute key packaging related activities as per this D&D plan. Xxxxxxx Xxxxxxx MEST (Value Engineering) Technician Provide project support. Xxxxxx Xxxxxx Packaging Manager Overall Packaging Leadership Team Member Roles Responsibilities Xxxxx Xxxxxx MEST (Labeling and Packaging) Manager Provide Design Control support. Provide input for this D&D plan. R&D Xxxxxx Xxxxx R&D Eng/Mgr Provide support for planning & execution of Design Verification/Validation as per this D&D plan. Quality Assurance Xxxxx Xxxxx QA Director Overall QA leadership Xxxxxx Xxxxxxx QA Manager QA project management. Provide input into this D&D plan. Xxxxxxx Xxxxx PQS/FAL Manager Provide support/direction for this D&D Plan Tatiana Del Xxxxx QA Engineer QA Support Operations Xxxx Xxxxxxx Mfg Manager Operations Management. Xxxx Xxxxxx Xxxxxxxx Mfg Eng Ops Provide project support. Cross-Functional Support Xxxxxx Xxxxxxx Regulatory Affairs Manager Overall Regulatory Affairs project management, provide input for Regulatory Approach Independent Peers Xxxxx Xxxxxxx R&D Mgr Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Xxxxxx Xxxxx QA Engineer Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Xxxxxx Xxxxx OPS Engineer Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Design & Development APPROACHES Marketing Marketing Objectives Responsibility of SRM. Volume Expectations Refer to Sections 3.3 and 3.3.1 of the Agreement for Minimum Volume com...
Manufacturing Site. During the term of this Agreement, Abbott shall manufacture Product using Xxxxxx’x facilities located in Des Plaines, Illinois, or wherever Abbott may relocate its manufacturing facilities; provided, however, Abbott must give at least ninety (90) days prior written notice to NeoGenomics of any such relocation. Xxxxxx’x new facility shall be subject to one (1) additional site inspection by NeoGenomics quality assurance personnel, in accordance with Section 8.2, and Abbott shall use commercially reasonable efforts to have the new manufacturing site become acceptable to NeoGenomics’ quality policies within nine (9) months of relocating Product manufacture.
Manufacturing Site. The Purchaser may terminate this Agreement on thirty (30) days written notice if [***] changes the Manufacturing Site at which API is Manufactured or the process used in the Manufacture of API. Any such termination pursuant to this Section 16.2 shall not be deemed to be due to a breach by the Supplier.
Manufacturing Site. (a) Performance of Manufacturing Services at Manufacturing Site. Manufacturer shall perform the Manufacturing Services solely at the Manufacturing Site, unless otherwise agreed in writing by Acorda.
Manufacturing Site. (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed)
Manufacturing Site will manufacture all Product to be supplied to SuperGen under this Agreement solely at ***’s manufacturing facility in *** (the “Manufacturing Facility”). *** will not commence any manufacture of Product for commercial distribution until successful process validation is completed pursuant to terms of this Agreement. *** may change the Manufacturing Facility, upon prior written notice and approval by SuperGen, if Product can be manufactured at the new site in accordance with all pertinent Regulatory Requirements, cGMPs, the Specifications and the Quality Systems Agreement, and delivered in accordance with ***’s delivery obligations under this Agreement. *** will be responsible for all scheduling related to the Manufacturing Facility and for the operation of such facility.
Manufacturing Site. Except as otherwise approved in writing by Client, AAA shall perform the Manufacturing Services exclusively at the Manufacturing Site in order to manufacture and supply Finished Goods to Client for sale in the Territory. AAA shall at its own cost obtain on a timely basis and maintain all necessary licenses, permits and approvals of Authorities, and make any required filings with Regulatory Authorities as further specified in Section 7.8, in respect of the operation of AAA’s business generally, the Manufacturing Site, and the performance of services of the nature of the Manufacturing Services. 2.6
Manufacturing Site. ICU shall initially manufacture the Products at the Facility. If ICU plans to move any manufacturing of Products to a location other than the Facility, ICU shall use commercially reasonable efforts to notify Hospira at least 60 days (but in any event not less than 30 days) in advance of such move and allow Hospira to inspect such new manufacturing facilities to ensure compliance of facilities, equipment, and procedures with applicable FDA regulations and cGMPs. ICU shall not manufacture Products at the new facility until such time as Hospira has completed its inspection confirming compliance. ICU shall use commercially reasonable efforts to ensure a smooth transition to a new manufacturing facility and to avoid delays in any such transition. Hospira shall use commercially reasonable efforts to complete its inspections on a timely basis to avoid delays in any such transition. In the event a manufacturing site change has an impact on any Regulatory Approval, ICU shall reimburse Hospira for the costs of any Regulatory Approval amendment, notification or resubmission deemed necessary by Hospira in its sole discretion as a result of such manufacturing site change and the manufacture of the Products to the new manufacturing site shall not begin until all Regulatory Approvals have been obtained.
Manufacturing Site. Patheon shall, or shall procure that its Affiliates shall, make available to Client and its Affiliates sufficient capacity for each Product at the relevant Manufacturing Site as is necessary to enable Patheon to Manufacture and supply the binding Yearly Forecast Volumes, as agreed between the parties pursuant to Section 4.2.1. Patheon may change the Manufacturing Site for the Products, provided that any change is approved in writing in advance by Client and is in compliance with Applicable Law and any applicable change control provisions in the Quality Agreement, including any requirement for the new Manufacturing Site to have Regulatory Approval. Client shall have the right to withhold their approval where it is acting reasonably and in good faith. Client may request a reasonable change to the Manufacturing Site for the Products at any time and Patheon shall use Commercially Reasonable Endeavours to accommodate such a request within such reasonable time frame as is agreed between the parties. In the event of a change of Manufacturing Site, the costs of such a change shall be borne according to the allocation agreed in good faith by the parties in respect thereof in accordance with the agreed allocation principles set out in the relevant Product Agreement from time to time.
Manufacturing Site. NEXUS will be entitled to choose within each Purchase Order (and AMS shall accept such choice) the site where the assembly and manufacture of the Product shall take place, should AMS acquire additional assembly or manufacturing sites.
