Manufacturing Site. New Carotid Stent Delivery System catalogs with 65cm 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, Xxxxx Xxxxxx OETS (Sustaining) Director Overall Project Leadership. Xxxxxx Xxxxxx OETS (Sustaining) Manager Project Manager. Provide input for this D&D plan. Xxxxx Xxxxxx Xxxx Lead) ETS (Sustaining) Engineer (Project Leader) Project leader. Plan and execute key activities as per this D&D plan. Xxxxx X. Xxxxxxxx OETS (Sustaining) Engineer Provide project support. Xxxxx Xxxx OETS (Sustaining) Engineer Provide project support, Xxxx Xxxxxxxx OETS (Sust/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 OETS (Sustaining) Technician Provide project support. Xxxxxx Xxxxxx Packaging Manager Overall Packaging Leadership Xxxxx Xxxxxx OETS (Sustaining) Engineer R&D Manager Provide Design Control support. Provide input for this D&D plan. Xxxxx Xxxxx R&D Engineer Provide support for planning & execution of Design Verification/Validation as per this D&D plan. 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 Xxxxxx Muftoz QA Engineer QA Support Operations Xxxxx Xxxxx Mfg Manager Operations Management, Xxxx Xxxxxx Xxxxxxxx Mfg Eng Ops Provide project support. Xxxxxxx Xxxxxxx Packaging Engineer Provide project support in the area of packaging, Plan and execute packaging related activities as per this D&D plan, Xxx Xxxxx Regulatory Affairs Manager Overall Regulatory Affairs project management, provide input for Regulatory Approach Xxxxx Xxxxxxxxxxxx R&D Mgr Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Xxxxxxx Muiloz QA Engineer Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Xxxxxx Hem OPS Engineer Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Responsibility of SRM. Demand expected is according to SRM Planning, current forecast as follows: Scenario 1 [***] [***] [***] [***] [***] [***] [***] Scenario 2 [***] [***] [***] [***] [***] [***] [***] Pricing for final customer is managed by SRM. Branding name strategy for 18 new Carotid Stent Delivery System catalogs - 65cm length will be selected by ...
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. Responsibility of SRM. Refer to Sections 3.3 and 3.3.1 of the Agreement for Minimum Volume commitments. Refer to Exhibit 5 of the Agreement for Forecast timelines and process. Pricing for final customer is managed by SRM. Branding name strategy for 36 new Carotid Stent Delivery System catalogs — 57 cm length will be selected by SRM. [*********] units will be manufactured as the Initial Shelf Stock (ISS) requirement for product launch. Manufacture and delivery of ISS is not included in Development Fees. SRM shall place a written purchase order for the ISS, the price of which is [*****] per unit. To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) To be determined by SRM (not part of this plan) As determined by Cordis, Cordis will leverage the TDI’s corresponding to the PMA approved PRECISE products marketed by Cordis, except those that are specific to the new length (57cm), which will be performed for the new length as set forth in the section Product Design Verification of this Design and Development Plan. Testing related to simulated use must be responsibility of SRM; since the clinical application of this product will be developed and validated by SRM.
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. (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed)
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. < Person responsible for manufacturing the medical device> < e.g. product name and model number>
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. Each Product Manufactured by or on behalf of Provider and supplied to Senti in accordance with cGMP will be Manufactured at the Facility identified in the applicable Statement of Work.
Manufacturing Site. During the Term, Qualigen shall manufacture all Products using Qualigen’s facilities located in Carlsbad, California. Qualigen shall give at least six (6) months prior written notice to Sekisui of any proposed relocation of the manufacturing of any Product. Any new facility proposed to be used by Qualigen in manufacturing any Product shall be subject to a new and separate audit by Sekisui personnel in accordance with Quality Systems Regulations (QSR), as well as ISO 13485.
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.
