Common use of Manufacturing Site Clause in Contracts

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 commitments. Refer to Exhibit 5 of the Agreement for Forecast timelines and process. Pricing Strategy Pricing for final customer is managed by SRM. Branding Name Strategy Branding name strategy for 36 new Carotid Stent Delivery System catalogs — 57 cm length will be selected by SRM. Initial Sales Forecast and ISS Requirements [*********] 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. Desired Clinical Indications To be determined by SRM (not part of this plan) Desired Performance Claims To be determined by SRM (not part of this plan) Key Marketing Activities To be determined by SRM (not part of this plan) Regulatory Distribution Region To be determined by SRM (not part of this plan) Regulatory Classification To be determined by SRM (not part of this plan) Submission Type To be determined by SRM (not part of this plan) Regulatory Pathway To be determined by SRM (not part of this plan) Promotional Claims To be determined by SRM (not part of this plan) Import/Export Requirements: To be determined by SRM (not part of this plan) Testing Requirements 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. New Carotid Stent Delivery System catalogs with 57 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. , FUNCTIONAL REPRESENTATIVES: Team members, roles, and responsibilities are subject to change at Cordis’ sole discretion. REPRESENTATIVES Team Member Roles Responsibilities OETS (Sustaining) / Operations Xxxxx Xxxxxx MEST OETS (Sustaining) Director Overall Project Leadership. Xxxxxx Xxxxxx MEST OETS (Value EngineeringSustaining) Manager Project Manager. Provide input for this D&D plan. Xxxxx Xxxxxx Xxxx Lead MEST Lead) ETS (Value EngineeringSustaining) Engineer (Project Leader) Project leader. Plan and execute key activities as per this D&D plan. Xxxxx X. Xxxxxxxx MIST OETS (Value EngineeringSustaining) Engineer Provide project support. Xxxxxx Xxxxxxxx MEST Xxxxx Xxxx OETS (Value EngineeringSustaining) Engineer Provide project support. , Xxxx Xxxxxxxx MEST OETS (Value Engineering /ContractorSust/Contractor) – - Packaging Engineer. 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 OETS (Value EngineeringSustaining) Technician Provide project support. Xxxxxx Xxxxxx Packaging Manager Overall Packaging Leadership Team Member Roles Responsibilities Xxxxx Xxxxxx MEST OETS (Labeling and PackagingSustaining) Engineer R&D Manager Provide Design Control support. Provide input for this D&D plan. R&D Xxxxxx Xxxxx Xxxxx R&D Eng/Mgr Engineer 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 Xxxxxx Muftoz QA Engineer QA Support Operations Xxxx Xxxxxxx 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, Cross-Functional Support Xxxxxx Xxxxxxx Xxx Xxxxx Regulatory Affairs Manager Overall Regulatory Affairs project management, provide input for Regulatory Approach Independent Peers Xxxxx Xxxxxxx Xxxxxxxxxxxx R&D Mgr Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Xxxxxx Xxxxx Xxxxxxx Muiloz QA Engineer Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan Xxxxxx Xxxxx Hem 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 Demand expected is according to Sections 3.3 SRM Planning, current forecast as follows: unit forecast as of 2/2/11 2011 2012 2013 2014 2015 2016 2017 Scenario 1 [***] [***] [***] [***] [***] [***] [***] Scenario 2 [***] [***] [***] [***] [***] [***] [***] Note: Forecast may be revised in a subsequent revision of this Design and 3.3.1 of the Agreement for Minimum Volume commitments. Refer to Exhibit 5 of the Agreement for Forecast timelines and processDevelopment Plan. Pricing Strategy Pricing for final customer is managed by SRM. Branding Name Strategy Branding name strategy for 36 18 new Carotid Stent Delivery System catalogs — 57 - 65cm length will be selected by SRM. Initial Sales Forecast and ISS Requirements [*********] 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. Desired Clinical Indications To be determined by SRM (not part of this plan) Desired Performance Claims To be determined by SRM (not part of this plan) Key Marketing Activities To be determined by SRM (not part of this plan) Regulatory Distribution Region To be determined by SRM (not part of this plan) Regulatory Classification To be determined by SRM (not part of this plan) Submission Type To be determined by SRM (not part of this plan) Regulatory Pathway To be determined by SRM (not part of this plan) Promotional Claims To be determined by SRM (not part of this plan) Import/Export Requirements: To be determined by SRM (not part of this plan) Testing Requirements 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 (5765 cm), 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.