Service introduction Due-Diligence (DD) & Engineering Report (ER) ® 1 What we can do ✚ To work out a facility-specialized Engineering Report (ER). ✚ To support the due-diligence (DD) by providing an ER, intensive with purpose focused and distinctive on clientʼs demand. ✚ To prepare the ED both in Japanese and in English to help client smoothly complete the DD of manufacturing facility. ® Copyright© CM Plus Corporation. All rights reserved 2 1. Support to clientʼs DD proceeding ✚ Features of the ER made by CM Plus  CM Plus is an independent firm without any capital relationship to contractors, property developers or financial sectors, etc. By that means, the ER made by CM Plus can keep the fairness and neutrality.  Specializing in project management of production facilities engineering, CM Plus makes it possible that an ER reflects all aspects including the production equipment from a professional standpoint. ✚ The key axis to evaluate the production facility projects General property facilities ® Copyright© CM Plus Corporation. All rights reserved Production facilities 3 2. Procedure of ER preparations ✚ CM Plusʼs engineering resources to be taken in use  ER is required to be made out in a limited period, based on the disclosed information, under an adequate and timely judgment.  It can be made out only by the engineers who well aware of the features of the production facilities. ✚ Investigation ・diagnosis implemented step-by-step Phase 1 • Base on disclosed information, interviews and site survey in the DD proceeding, to outline the significant risks in a timely manner. Phase 2 • Base on more specific documents, site investigation results, to go further with the risk assessment conducted at Phase 1 to get ready for ED preparation. ® Copyright© CM Plus Corporation. All rights reserved 4 2. Procedure of ER preparations ✚ Steps to reach the completion of ER 1. Survey items and survey scope identification • Survey method discussion with Client. • Since there is no same case in the world, the details of the case must be discussed before the start of the site survey. 2. Obtain the predetermined conditions/ documents • Obtaining and confirming of the predetermined conditions/documents. • Receive related information in writing or in hearing. 3. Performing the survey • Based on document, list up the survey items and conduct a technical hearing /site survey. 1. Survey items and survey scope review • Discuss over the preliminary survey result with Client. • Survey review, reduction or re-investigation. 5. Performing the risk assessment • Analysis of the severity of risks item by item. Report preparation • Report drafting • Report finalizing • Description of actions to be taken should be included. 6. ® Copyright© CM Plus Corporation. All rights reserved 5 3. Extraction of survey items in Engineering Report ✚ER created on sufficient experience basis CM Plus will extract the survey items on the basis of the limited documents in use of the significantly accumulated experiences in production facilities engineering. Upon extraction, the survey items will be classified based on the object hierarchy, then a list of survey items will be developed. ® Copyright© CM Plus Corporation. All rights reserved 6 4. Risk assessment of survey items ✚ Risk mapping The risk assessment will be performed from the viewpoint of two impacts towards the developed survey items, one is cost impact and the other is risk impact. 1. Risk assessment methodology Each item will be evaluated using the following matrix. ① Cost impact ＝ risk severity × cost significance ② Risk impact ＝ risk severity × risk frequency Cost Impact Risk impact ® Copyright© CM Plus Corporation. All rights reserved ＡＢＣＡＡＢＣＢＢＢＣＣＢＣＣ 7 4. Risk assessment of survey items ✚ Risk mapping 2. Rating the risk magnitude (Risk assessment methodology) After evaluating by ①cost impact × ②risk impact, put the survey items into the evaluation items based on the object hierarchy as below, then make the risk mapping by going further with the collective evaluation or call it a “risk magnitude order”. Evaluation of cost impact Cost impact Ａ More than 100 million yen Cost impact Ｂ More than 50 million yen Cost impact Ｃ Below 50 million yen ® Copyright© CM Plus Corporation. All rights reserved 8 4. Risk assessment of survey items ✚ Risk mapping 3. Sample of the facility risk object hierarchy ■第一三共株式会社静岡工場　施設リスク項目の展開と評価大項目調査項目 Pre .- D D 今回調査実施１）製剤主要設備仕様 △ B × B ＝２）生産サポ－ト設備 (ﾌﾟﾛｾｽｶﾞｽ、製造用水) △ B × B ＝ B ３）査察対応状況 -- B × Ｂ＝Ｂ４）品質管理状況 -- C × Ｂ＝Ｃ１）高活性製造ライン (失活方法) △ C × Ｃ＝Ｃ２） GMP上のクロスコンタミの懸念について △ A × A ＝ A 中項目コスト影響度リスク影響度 (A～C) リスク・マグニチュード (A～C) (A～C) ３．１．１ GMP三極対応 B ３．１．２製造の汎用性３．１ CMO 製造受託１）組織体制、必要人員 ○ B × B ＝ B ２）必要資格と人員数 ○ C × C ＝ C ３）雇用確保方法 -- A × A ＝ A １） MES(R/3)～WMS～ERP 接続性 △ A × A ＝ A １）原水供給/水質、用途 ○ A × B ＝Ｂ２）停電対策 -- C × C ＝ C トラブル事例 -- Ｂ × Ｂ＝Ｂエネルギー使用量 -- Ｂ × Ｂ＝Ｂ３．１．３運営３．１．４システム３．１．５設備安定稼働性３）４）５）設備保全状況 -- A × Ｂ＝Ｂ２）建築・空調・電気設備老朽化程度 -- A × Ｂ＝Ｂ３）製剤設備老朽化程度 -- A × Ｂ＝Ｂ１）耐震性能 ○ Ｂ × Ｂ＝Ｂ２）地盤不同沈下 ○ Ｃ × Ｃ＝Ｃ１）敷地制約 ○ Ｃ × Ｃ＝Ｃ２）建築及び設備的な概要把握 ○ Ｃ × Ｃ＝Ｃ３）受電容量 ○ C × C ＝Ｃ１）埋設物 ○ A × A ＝ A ２）土壌 ○ A × A ＝ A ３） PCB保管 ○ B × Ｃ＝Ｃ４）危険物保管 △ Ｃ × Ｃ＝Ｃ５）焼却炉 ○ Ｃ × Ｃ＝Ｃ６）ボイラ－燃料 ○ Ｃ × Ｃ＝Ｃ７）排水 ○ Ｃ × Ｃ＝Ｃ１）届出書類、協定書 ○ C × C ＝ C アスベスト材 ○ A × Ｂ＝Ｂ -- B × B ＝ B １）３．２．１設備寿命３．２．２ Pre.-DDの目的買収後に発生するコストの有無とその程度(マグニチュードオーダー)の把握３．２施設及び運営に関する顕在的、潜在的リスクの洗い出しと評価構造施設将来価値３．２．３拡張性３．３環境対応３．４．１官庁申請１）３．４その他、法令遵守３．４．２建材２） ® Copyright© CM Plus Corporation. All rights reserved 不正建材 (耐火ボ－ド等) ○：資料入手出来たもの △：資料が不足しているもの --：未受領 9 5. Extract/evaluate the critical items of ER ✚CM Plus will extract the principal risks or higher risk impact items on the basis of the risk mapping methodology, and propose our solutions to those risks. ✚It is available for us to provide the related data on rating of asset values that will be definitely useful to activate the DD proceeding. ® Copyright© CM Plus Corporation. All rights reserved 10 6. Rich in human resource and experience ✚CM Plus is a management company specializing in the engineering of the production facility. ✚On the next sheet, you can see that our human resource consists of the qualified people rich in skill, know-how that, we believe, will lead to the success of your DD for production facilities. ® Copyright© CM Plus Corporation. All rights reserved 11 7. Qualifications required for the ER creation ○ ： busin ess assoc iate d Remarks Environmental Nature disaster PC & QC Regulation Maitenance ○ ○ ○ IT Equipment ○ ○ ○ Operation structure Drainage/Burning EQ Utility EQ ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ○ ○ ● ● ● ● Hazard Material storage Logistic EQ Process EQ Lifts Legal HVAC Electrical Interior structure Exterior ® Copyright© CM Plus Corporation. All rights reserved ：Engin ee rin g skill re quired ● ：Spec ialize d in Facilities Production facilities Roof Location Architect 1st class PE [comprehensive tech supervision] PE [construction] PE [Mechanical] PE [Electrical & electronical] PE [sanitory system] PE [Environmental] PE [Application physiotherapy] PE [Management engineering] Special building surveyor Building facility expert Building environmental facility expert Building facility inspector Licensed electrician Construction ME [1st class] Piping work ME [1st class] Electrical ME [1st class] Lift inspector 1st class health administrator Environment certified measurer Building structure expert Building and Facilities General management technician Facility Manager Compaensation business management officer Building renovation management engineer Building finish diagnostic engineer Building equipment diagnostic engineer Soil environment supervision officer Logistics management officer Information processing professional engineer Qualified Energy Manager Fire protection engineer Engineering Manager ： Nationaly qu alifie d Building Plumbing ◆Qu alific ations assoc iate with ER preparation ER evaluation scope Landscape ✚ CM Plus will allow only the qualified subject matter experts from our human resources to involve the evaluation service for you. ● ● ○ ○ ● ● ● ● ● ● ● ○ ○ ○ ○ ● ● ○ ● ● ● ● ○ ○ ○ ○ ● ● ● ● ● ● ● ● ● ● ● ● ● ○ ● ● ● ● ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ● ● ● ● ○ ○ ○ ● ● ● ● ● ● ● ● ○ ○ ● ● ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ● ● ○ ○ ○ ○ ○ ○ ○ ○ ○ Former phama plant director・Eng GM・SM ● ● ● ○ ○ ● ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ● ● ● ● ● ● ○ ● ● ● ○ ○ ○ ○ Former phama Eng GM・SM 12