Manufacturing Site Sample Clauses

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. 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. 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, ▇▇▇▇▇ ▇▇▇▇▇▇ OETS (Sustaining) Director Overall Project Leadership. ▇▇▇▇▇▇ ▇▇▇▇▇▇ OETS (Sustaining) Manager Project Manager. Provide input for this D&D plan. ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ Lead) ETS (Sustaining) Engineer (Project Leader) Project leader. Plan and execute key activities as per this D&D plan. ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ OETS (Sustaining) Engineer Provide project support. ▇▇▇▇▇ ▇▇▇▇ OETS (Sustaining) Engineer Provide project support, ▇▇▇▇ ▇▇▇▇▇▇▇▇ 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. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ OETS (Sustaining) Technician Provide project support. ▇▇▇▇▇▇ ▇▇▇▇▇▇ Packaging Manager Overall Packaging Leadership ▇▇▇▇▇ ▇▇▇▇▇▇ OETS (Sustaining) Engineer R&D Manager Provide Design Control support. Provide input for this D&D plan. ▇▇▇▇▇ ▇▇▇▇▇ R&D Engineer Provide support for planning & execution of Design Verification/Validation as per this D&D plan. ▇▇▇▇▇ ▇▇▇▇▇ QA Director Overall QA leadership ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ QA Manager QA project management. Provide input into this D&D plan. ▇▇▇▇▇▇▇ ▇▇▇▇▇ PQS/FAL Manager Provide support/direction for this D&D Plan ▇▇▇▇▇▇ Muftoz QA Engineer QA Support Operations ▇▇▇▇▇ ▇▇▇▇▇ Mfg Manager Operations Management, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Mfg Eng Ops Provide project support. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Packaging Engineer Provide project support in the area of packaging, Plan and execute packaging related activities as per this D&D plan, ▇▇▇ ▇▇▇▇▇ Regulatory Affairs Manager Overall Regulatory Affairs project management, provide input for Regulatory Approach ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ R&D Mgr Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan ▇▇▇▇▇▇▇ Muiloz QA Engineer Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan ▇▇▇▇▇▇ 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. During the term of this Agreement, Abbott shall manufacture Product using ▇▇▇▇▇▇’▇ 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. ▇▇▇▇▇▇’▇ 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. < Person responsible for manufacturing the medical device> < e.g. product name and model number>

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. 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 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. Seller warrants that the Products will be manufactured at the manufacturing site as set forth in Exhibit A, which site has been qualified by HP. Any change in manufacturing facility shall be considered an Engineering Change subject to Section 9 above.