Defect Tracking. During the development of Gemini both HP and Bruker will report and or record all hardware and software defects found in the product. HP and Bruker, will evaluate the defects and based on product specification will suggest corrective measures, make corrections, make corrections, retest corrected changes, and jointly resolve defects. Bruker will maintain a database for the software defects. The TOP/3 system or equivalent will be used. The database will reside at Bruker, but copies will be made available to HP as needed. HP and Bruker will jointly review the submitted defects set severity levels and schedule fixes. For hardware a defect system will be put in place in which will call attention to any departure for specifications found in the PDS, Project Plan, Hardware Quality and Regulatory Plan or ERS documents. The information in this defect system will be communicated based on change or upon request from either HP or Bruker. Bruker will develop and maintain the defect tracking system for the hardware. REQUIREMENTS TRACEABILITY In accordance with product validation requirements basic user requirements listed in this Traceability Matrix are tracked through the Lifecycle Documents according to the following hardware and software tables. ------------------------------ ------------------------ -------------------------- -------------------------- PRODUCT DATA SHEET EXTERNAL REFERENCE USER REQUIREMENT (PDS) SECTION SPECIFICATION (ERS) QUALITY PLAN REFERENCE ------------------------------ ------------------------ -------------------------- -------------------------- HARDWARE REQUIREMENTS ------------------------------ ------------------------ -------------------------- -------------------------- ESI, APCI, NanoElectrospray HW/Firmware HW/Firmware compatibility Functionality Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Mass Range / Resolution / HW/Firmware HW/Firmware Analytical Performance Scan Speed Functionality Functionality Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- MS/MS Performance HW/Firmware HW/Firmware Analytical Performance ------------------------------ ------------------------ -------------------------- -------------------------- ------------------------------ ------------------------ -------------------------- -------------------------- PRODUCT DATA SHEET EXTERNAL REFERENCE USER REQUIREMENT (PDS) SECTION SPECIFICATION (ERS) QUALITY PLAN REFERENCE ------------------------------ ------------------------ -------------------------- -------------------------- Functionality Functionality Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- ICC Performance HW/Firmware Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Pos/Neg Switching HW/Firmware Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Mass Stability Performance HW/Firmware Analytical Performance Functionality Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- LC/MS and LC/MS/MS Performance Performance Analytical Performance Sensitivity Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- Electrical Interface HW/Firmware HW/Firmware Requirements Functionality Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Packaging HW/Firmware Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Regulatory, Safety, Environmental, Safety, Hardware Quality Plan Environmental Reliability ------------------------------ ------------------------ -------------------------- -------------------------- Diagnostics Supportability System Diagnostics tools built in ------------------------------ ------------------------ -------------------------- -------------------------- System Configuration Compatibility Matrix SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Reliability ------------------------------ ------------------------ -------------------------- -------------------------- ------------------------------ ------------------------ -------------------------- -------------------------- SOFTWARE REQUIREMENTS ------------------------------ ------------------------ -------------------------- -------------------------- Automated Tuning Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Full System Control Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Scan and Segment Editing Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Data dependent acquisition modes Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Full profile data Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Software copy protection Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Peptide, Protein Tools Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- [*](15) Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- [*] Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- -------- (15) [*] Indicates information has been omitted and separately filed with the Securities and Exchange Commission pursuant to an application for an order declaring confidential treatment thereof. ------------------------------ ------------------------ -------------------------- -------------------------- PRODUCT DATA SHEET EXTERNAL REFERENCE USER REQUIREMENT (PDS) SECTION SPECIFICATION (ERS) QUALITY PLAN REFERENCE ------------------------------ ------------------------ -------------------------- -------------------------- NT Operating System Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Y2K compliance Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Help system Usability/Knowledge SW ERS Tools ------------------------------ ------------------------ -------------------------- -------------------------- LIFECYCLE CHECK POINTS/LIFECYCLE CUSTOMIZATION At the conclusion of each phase in the project, (Lab Phase, Production Prototype Phase, Pilot Run as well as software Investigation/Design, Implementation, and Test Phases) a joint HP/Bruker check point meeting will be held to review the project status and determine if the project should transition to the subsequent phase. The major activities for each phase are found in the following Lifecycle Checklists. The joint meetings will be face-to-face, by video-conference, or by teleconference. For this project the standard HP hardware lifecycle checkpoints will be used. For the Gemini software development one common Proposal Phase has been used for the 3.0, 3.1, 3.2 and 4.0 releases of Esquire-LC/Gemini Software. Each of these releases will have a merged Investigation and Design Phases referred to as the "ID Phase". The Implementation Phase is referred to as the "I Phase". LIFECYCLE CHECKPOINT SCHEDULE OVERVIEW ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Checkpoint 2/99 3/99 4/99 5/99 6/99 7/99 8/99 9/99 10/99 11/99 12/99 1/00 2/00 3/00 ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- HW Phases ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Invest. Phase X X I-L ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Lab Phase X X X X X X L-PP ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- PP Phase X X X PP-PR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Pilot Run X X MR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- SW Phases ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- (16)[*] Test X X MR Phase ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] ID Phase X X ID-I ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] I Phase X X TR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] Test Phase X X MR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] ID Phase X X ID-I ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] I Phase X X X X TR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] Test Phase X X X MR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] ID Phase X X ID-I ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] I Phase X X X TR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] Test Phase MR 6/00 ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- -------- (16) [*] Indicates information has been omitted and separately filed with the Securities and Exchange Commission pursuant to an application for an order declaring confidential treatment thereof. INVESTIGATION PHASE/ENTWURFSPHASE ------------------- ----------------- ----------------- ----------------- ----------------- ----------------- PRODUCT ID: PROJECT ID: DATE: ------------------- ----------------- ----------------- ----------------- ----------------- ----------------- TARGET DATES: Projected Time: - 15 Apr 1999 OBJECTIVES: ------- ------------------------------------------------------ ---------------------- ----------------------- STATUS LOCATION ------- ------------------------------------------------------ ---------------------- ----------------------- PROJECT MANAGEMENT TEAM ------- ------------------------------------------------------ ---------------------- ----------------------- Update Project Documents ------- ------------------------------------------------------ ---------------------- ----------------------- Sign-off on all Lifecycle documents ------- ------------------------------------------------------ ---------------------- ----------------------- Manufacturing Release requirements (MR) reviewed ------- ------------------------------------------------------ ---------------------- ----------------------- Establish communication lines for lifecycle check points ------- ------------------------------------------------------ ---------------------- ----------------------- Joint HP/Bruker Project Lifecycle check-point review ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- RESEARCH AND DEVELOPMENT/QUALITY ------- ------------------------------------------------------ ---------------------- ----------------------- Complete major components risk assessment ------- ------------------------------------------------------ ---------------------- ----------------------- Finalize development schedule ------- ------------------------------------------------------ ---------------------- ----------------------- Agree upon environmental, safety, and EMV tests ------- ------------------------------------------------------ ---------------------- ----------------------- [*](17) ------- ------------------------------------------------------ ---------------------- ----------------------- [*]: - Quality Improvement Plan, on target and jointly reviewed - Bruker requests (issue not resolved): Contingency Plan implemented and on target ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- MARKETING/LEARNING PRODUCTS/PRODUCT SUPPORT ------- ------------------------------------------------------ ---------------------- ----------------------- Complete compatibility matrix ------- ------------------------------------------------------ ---------------------- ----------------------- Define required learning products with schedule ------- ------------------------------------------------------ ---------------------- ----------------------- Define service training materials with schedule ------- ------------------------------------------------------ ---------------------- ----------------------- Software release schedule outlined ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- MANUFACTURING ------- ------------------------------------------------------ ---------------------- ----------------------- Set up kit production at HP ------- ------------------------------------------------------ ---------------------- ----------------------- Manufacturing Plan developed (draft). Critical production issues defined and plans developed (draft) ------- ------------------------------------------------------ ---------------------- ----------------------- Preliminary production documentation reviewed (draft) ------- ------------------------------------------------------ ---------------------- ----------------------- Product Stewardship plan developed (CSA, ISO) (draft) ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- -------- (17) [*] Indicates information has been omitted and separately filed with the Securities and Exchange Commission pursuant to an application for an order declaring confidential treatment thereof.
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Defect Tracking. During the development of Gemini both HP and Bruker will report and or record all hardware and software defects found in the product. HP and Bruker, will evaluate the defects and based on product specification will suggest corrective measures, make corrections, make corrections, retest corrected changes, and jointly resolve defects. Bruker will maintain a database for the software defects. The TOP/3 system or equivalent will be used. The database will reside at Bruker, but copies will be made available to HP as needed. HP and Bruker will jointly review the submitted defects set severity levels and schedule fixes. For hardware a defect system will be put in place in which will call attention to any departure for specifications found in the PDS, Project Plan, Hardware Quality and Regulatory Plan or ERS documents. The information in this defect system will be communicated based on change or upon request from either HP or Bruker. Bruker will develop and maintain the defect tracking system for the hardware. REQUIREMENTS TRACEABILITY In accordance with product validation requirements basic user requirements listed in this Traceability Matrix are tracked through the Lifecycle Documents according to the following hardware and software tables. ------------------------------ ------------------------ -------------------------- -------------------------- PRODUCT DATA SHEET EXTERNAL REFERENCE USER REQUIREMENT (PDS) SECTION SPECIFICATION (ERS) QUALITY PLAN REFERENCE ------------------------------ ------------------------ -------------------------- -------------------------- HARDWARE REQUIREMENTS ------------------------------ ------------------------ -------------------------- -------------------------- ESI, APCI, NanoElectrospray HW/Firmware HW/Firmware compatibility Functionality Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Mass Range / Resolution / HW/Firmware HW/Firmware Analytical Performance Scan Speed Functionality Functionality Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- MS/MS Performance HW/Firmware HW/Firmware Analytical Performance ------------------------------ ------------------------ -------------------------- -------------------------- ------------------------------ ------------------------ -------------------------- -------------------------- PRODUCT DATA SHEET EXTERNAL REFERENCE USER REQUIREMENT (PDS) SECTION SPECIFICATION (ERS) QUALITY PLAN REFERENCE ------------------------------ ------------------------ -------------------------- -------------------------- Functionality Functionality Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- ICC Performance HW/Firmware Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Pos/Neg Switching HW/Firmware Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Mass Stability Performance HW/Firmware Analytical Performance Functionality Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- LC/MS and LC/MS/MS Performance Performance Analytical Performance Sensitivity Quality Plan ------------------------------ ------------------------ -------------------------- -------------------------- Electrical Interface HW/Firmware HW/Firmware Requirements Functionality Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Packaging HW/Firmware Functionality ------------------------------ ------------------------ -------------------------- -------------------------- Regulatory, Safety, Environmental, Safety, Hardware Quality Plan Environmental Reliability ------------------------------ ------------------------ -------------------------- -------------------------- Diagnostics Supportability System Diagnostics tools built in ------------------------------ ------------------------ -------------------------- -------------------------- System Configuration Compatibility Matrix SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Reliability ------------------------------ ------------------------ -------------------------- -------------------------- ------------------------------ ------------------------ -------------------------- -------------------------- SOFTWARE REQUIREMENTS ------------------------------ ------------------------ -------------------------- -------------------------- Automated Tuning Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Full System Control Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Scan and Segment Editing Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Data dependent acquisition modes Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Full profile data Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Software copy protection Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Peptide, Protein Tools Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- [*](15) Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- [*] Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- -------- (15) [*] Indicates information has been omitted and separately filed with the Securities and Exchange Commission pursuant to an application for an order declaring confidential treatment thereof. ------------------------------ ------------------------ -------------------------- -------------------------- PRODUCT DATA SHEET EXTERNAL REFERENCE USER REQUIREMENT (PDS) SECTION SPECIFICATION (ERS) QUALITY PLAN REFERENCE ------------------------------ ------------------------ -------------------------- -------------------------- NT Operating System Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Y2K compliance Software Functionality SW ERS SW Test Plan ------------------------------ ------------------------ -------------------------- -------------------------- Help system Usability/Knowledge SW ERS Tools ------------------------------ ------------------------ -------------------------- -------------------------- LIFECYCLE CHECK POINTS/LIFECYCLE CUSTOMIZATION At the conclusion of each phase in the project, (Lab Phase, Production Prototype Phase, Pilot Run as well as software Investigation/Design, Implementation, and Test Phases) a joint HP/Bruker check point meeting will be held to review the project status and determine if the project should transition to the subsequent phase. The major activities for each phase are found in the following Lifecycle Checklists. The joint meetings will be face-to-face, by video-conference, or by teleconference. For this project the standard HP hardware lifecycle checkpoints will be used. For the Gemini software development one common Proposal Phase has been used for the 3.0, 3.1, 3.2 and 4.0 releases of Esquire-LC/Gemini Software. Each of these releases will have a merged Investigation and Design Phases referred to as the "ID Phase". The Implementation Phase is referred to as the "I Phase". LIFECYCLE CHECKPOINT SCHEDULE OVERVIEW ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Checkpoint 2/99 3/99 4/99 5/99 6/99 7/99 8/99 9/99 10/99 11/99 12/99 1/00 2/00 3/00 ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- HW Phases ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Invest. Phase X X I-L ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Lab Phase X X X X X X L-PP ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- PP Phase X X X PP-PR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- Pilot Run X X MR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- SW Phases ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- (16)[*] Test X X MR Phase ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] ID Phase X X ID-I ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] I Phase X X TR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] Test Phase X X MR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] ID Phase X X ID-I ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] I Phase X X X X TR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] Test Phase X X X MR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] ID Phase X X ID-I ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] I Phase X X X TR ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- [*] Test Phase MR 6/00 ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- ---------------- ------ ----- ------ ------ ----- ------ ------ ----- ------ ------ ------ ----- ------ ----- -------- (16) [*] Indicates information has been omitted and separately filed with the Securities and Exchange Commission pursuant to an application for an order declaring confidential treatment thereof. INVESTIGATION PHASE/ENTWURFSPHASE ------------------- ----------------- ----------------- ----------------- ----------------- ----------------- PRODUCT ID: PROJECT ID: DATE: ------------------- ----------------- ----------------- ----------------- ----------------- ----------------- TARGET DATES: Projected Time: - 15 Apr 1999 OBJECTIVES: ------- ------------------------------------------------------ ---------------------- ----------------------- STATUS LOCATION ------- ------------------------------------------------------ ---------------------- ----------------------- PROJECT MANAGEMENT TEAM ------- ------------------------------------------------------ ---------------------- ----------------------- Update Project Documents ------- ------------------------------------------------------ ---------------------- ----------------------- Sign-off on all Lifecycle documents ------- ------------------------------------------------------ ---------------------- ----------------------- Manufacturing Release requirements (MR) reviewed ------- ------------------------------------------------------ ---------------------- ----------------------- Establish communication lines for lifecycle check points ------- ------------------------------------------------------ ---------------------- ----------------------- Joint HP/Bruker Project Lifecycle check-point review ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- RESEARCH AND DEVELOPMENT/QUALITY ------- ------------------------------------------------------ ---------------------- ----------------------- Complete major components risk assessment ------- ------------------------------------------------------ ---------------------- ----------------------- Finalize development schedule ------- ------------------------------------------------------ ---------------------- ----------------------- Agree upon environmental, safety, and EMV tests ------- ------------------------------------------------------ ---------------------- ----------------------- [*](17) ------- ------------------------------------------------------ ---------------------- ----------------------- [*]: - Quality Improvement Plan, on target and jointly reviewed - Bruker requests (issue not resolved): Contingency Plan implemented and on target ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- MARKETING/LEARNING PRODUCTS/PRODUCT SUPPORT ------- ------------------------------------------------------ ---------------------- ----------------------- Complete compatibility matrix ------- ------------------------------------------------------ ---------------------- ----------------------- Define required learning products with schedule ------- ------------------------------------------------------ ---------------------- ----------------------- Define service training materials with schedule ------- ------------------------------------------------------ ---------------------- ----------------------- Software release schedule outlined ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- MANUFACTURING ------- ------------------------------------------------------ ---------------------- ----------------------- Set up kit production at HP ------- ------------------------------------------------------ ---------------------- ----------------------- Manufacturing Plan developed (draft). Critical production issues defined and plans developed (draft) ------- ------------------------------------------------------ ---------------------- ----------------------- Preliminary production documentation reviewed (draft) ------- ------------------------------------------------------ ---------------------- ----------------------- Product Stewardship plan developed (CSA, ISO) (draft) ------- ------------------------------------------------------ ---------------------- ----------------------- ------- ------------------------------------------------------ ---------------------- ----------------------- -------- (17) [*] Indicates information has been omitted and separately filed with the Securities and Exchange Commission pursuant to an application for an order declaring confidential treatment thereof.REQUIREMENTS
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