隨著經濟活動全球化及資本移動自由化，跨國企業及個人之資產與所得分佈全世界，且因稅捐稽徵機關與納稅人間資訊不對稱，使得稅務資訊蒐集異常困難，稅捐稽徵機關在查核跨國案件時面臨極大挑戰，國際租稅合作與資訊交換成為各國稅捐稽徵機關用以處理國際租稅規避案件之重要工具。 本文就稅務資訊交換介紹國際稅約協定範本及其發展，並與我國經濟體相當之香港、新加坡及先進國家美國、瑞士等國家及OECD、UN及EU等國際機構所公布之國際租稅最新發展進行比較。本文研究歸納，資訊交換為影響我國洽簽租稅協定成敗之關鍵因素，進行銀行資訊交換應不影響我國發展為國際金融中心，支持財政部推動洽簽包括資訊交換之租稅協定。本文建議因應國際資訊交換之趨勢，我國應加強稽徵人員訓練、進行稅捐稽徵法第5條修法、確認租稅協定之法律位階、擴大租稅協定網絡之修法及加強宣導租稅資訊交換保密性等面向，強化我國資訊交換效能。 / Due to the globalization of economic activities, the labialization of capital transactions, individual worldwide assets and income and the asymmetric information of taxpayers and tax authorities, it is difficult for tax authorities to collect information. International cooperation in tax matters is crucial to ensuring the administration and enforcement of countries’ tax laws as cross border tax evasion becomes easier with the liberalization of financial markets. This thesis first introduces the development of the models of tax convention with special reference to EOI, it then makes a comparison of the measurements of EOI in the economies such as Hong Kong, Singapore, Switzerland, and the United States, and also looks at recent publications on EOI by OECD, UN and EU. It is concluded that EOI is the key to conclude tax treaties, that EOI of bank information will not adversely affect Taiwan government policy to become an international financial center, and that Ministry of Finance is supported to conclude tax treaties including EOI. It is suggested that strengthening the efficiency and capability of EOI in the aspects of strengthening the training of the tax collectors, amendment of Article 5 of the Tax Collection Act, confirmation of the legal status of tax treaties, broadening of the net work of tax treaties and promotion of the importance of the confidentiality of the EOI, so as to follow the international trend of EOI.

租稅協定不僅協調各國間稅收關係並妥善劃分課稅管轄權，進而降低企業全球化經營下所面臨的租稅課徵不確定性。然而國外文獻關於租稅協定對直接投資或海外關係企業活動之成效仍有諸多爭議，且國內仍未有利用長期性個體資料來檢視租稅協定效果的研究，因此本文以 2000 年至 2013年台灣上市公司之海外關係企業的財務資料進行分析。另外，因近年各國日益重視反避稅措施與跨國間稅收的徵管合作，故本文也進一步探討利益限制條款和資訊交換的嚴謹程度對於海外關係企業營運活動之影響。 本文建構三個固定效果模型來分析不平衡追蹤資料，其中模型一分析租稅協定對於海外關係企業營運活動的影響，而模型二檢視利益限制條款是否為其中的重要因素，模型三則分析資訊交換條款的嚴格程度是否影響海外關係企業的營運規模。實證結果顯示不論是租稅協定本身、利益限制或是資訊交換皆為影響台灣上市公司海外關係企業營運活動之重要關鍵。租稅協定的生效不僅造成海外關係企業的銷售額下降，並隨著資訊交換規範越嚴格，其下降的幅度越大。最後，在細分不同產業的條件下，得歸納出租稅協定帶來的效果並不一致之結論。

東柏林圍牆倒塌，金磚四國崛起，使得第三世界國家的經濟能力大幅提升，對能源及石化產品的需求也日益增加，促使全球對石化產業之投資大幅暴增且投資規模也較前期更大。為能加速獲利，業主經常要求統包工程公司能縮短1/3之工期。因此，統包工程公司需不斷研發及創新，並使用有別於傳統模式之作業方法，才可達成此縮短工期之目標。 近年由於電腦軟硬體進步神速及網際網路之普及化，提供了一個資訊交換的新環境。許多跨國作業、同步工程之應用系統紛紛被提出，但仍無法有效解決當前之問題，反而形成許多自動化孤島之資訊作業。 本研究主要目的在於探討如何利用先進資訊科技技術與國際共通的資訊標準規範，建立製程工廠統包工程所需之「建廠資訊生命週期管理」系統，將重要資訊予以電子化、結構化及標準化。透過電腦網路通訊及資料庫技術，使建廠過程能提供優良資訊品質，供參與建廠人員能透過此透明化之系統，使資訊得以整合與共享，確保資訊品質之完整、正確及一致性。 建廠工程之作業有許多不同的階段，本研究擬針對「建廠資訊生命週期管理」系統提出完整之規劃架構，但因本系統相當龐大，無法於短時間內完成全部之系統雛型，故，本著「Think Big, Start Small, Scale Fast」之理念，本研究將先對產製最多資訊之設計階段先行建立系統雛型，作為示範性之先導開發工作。本研究所獲得之主要結論如下: 一、 導入標準資訊規範是正確途徑 二、 為縮短建廠時間，需建立資訊整合與共享環境 三、 要提升統包工程公司之競爭力，需建立全球化作業平台 四、 要提升資訊品質需將文件中心轉變為資訊中心 關鍵字: 資訊生命週期管理、製程工廠、統包工程、圖形交換標準 建廠資訊交換標準、建廠工程活動、資訊品質、標準資訊規範 / The 3rd world economy has been largely improved resulting from the collapse of the Eastern Berlin wall and the rise of the Brics. Since then, the investment in the petroleum/chemical industries is increased triggered from a strong demand of the energy and petroleum/ chemical products. To expedite the profit return, the clients will usually request the turnkey project company to condense the plant’s engineering time to at least 1/3 of the original scheduled. Therefore, the turnkey project company needs to continuously engage in its R&D and create an innovation method different from the traditional one to fulfill with clients’ expectation. Owing to the rapid progress of the hardwares and softwares together with the popularity of the internet, it provids a new environment for the information exchange. Although numerous applications for global operation and concurrent had been announced, it still couldn’t resolve the existing problems, instead, it caused another problem and leads the information to the Islands of automation. The purpose of this study is to find out how to utilize the advanced information technology and worldwide standadized information specification to establish a 「Plant Information Lifecycle Management-PILM」system for the Process Plant. It is the hope that through the aforesaid system, user can transform their important information into a electronic、structured and standadized formular. In addition, by using the Internet communation and database technology, it can help the user to integrate and share information through this transparent system and ensure the completeness、correctness and consistency of the information quality. There are many phases in the plant engineering operation. Although this study is striving to provide a complete designing framework for the system of 「Plant Information Lifecycle Management」, however ,it is definitely impossible to complete the whole system prototype for this huge system during such a short period. Therefore, this study will focus only on the “Design Phase” based on the core principle “Think Big, Start Small and Scale Fast”. Most of the information will be emerged during the Design Phase, so that, a system prototype for this phase will be designed as an initiative development model. The major conclusions for this study are as follows: 1. The international standards should be adopted by the Turnkey project company. 2. To reduce the plant engineering time, an integral and share environment (the PILM system) should be built. 3. To enhance the competitiveness of the Turnkey project company, a global application platform (i.e. The PILM system) needs to be established. 4. To lift the information quality, the document centric needs to be transformed to data centric. Keyword: ISO 10303, STEP, ISO 15926, Plant Information Lifecycle Management , UML, EPC(Engineering/Procurement/Construction), Turn-Key

生物藥品是很多先前具致命性和難以治療的疾病領域，像是癌症、自體免疫疾病及神經系統疾病內最被看好的現行新穎療法。近年來，隨著探索出突破性小分子藥物愈趨困難，加上生物藥品在新藥研發過程中有較低的折損率與較高的成功產出率，使得越來越多藥廠紛紛轉向開發利潤豐厚的大分子生物產品。此外許多暢銷生物藥品專利期即將屆至，從而帶來對相對價廉、通常被稱為原廠生物藥品仿製版本之「生物相似性藥品」的龐大治療需求。然而，由於生物藥品和小分子藥物在分子大小及結構複雜程度方面存在截然不同的特性與本質差異，因此建立一套專屬於生物相似性藥品的上市許可規範勢在必行。 作為於2010年3月23日正式簽署公告之「患者保護及可負擔照護法案」中的一部分，美國國會通過了「生物藥品價格競爭與創新法」(BPCIA)。BPCIA的生效被視為製藥產業最重要的變革之一，旨在藉由競爭達到維護公眾健康、促進生物技術創新和控制醫療支出之目的，同時取得適當之三方利益平衡。BPCIA即以Hatch-Waxman法案下的化學學名藥核准途徑為模版，創建生物藥品簡易上市申請程序。 本論文的結構主要區分為兩大部分進行研究，其一提供了製藥產業概觀與全球生物藥品市場的發展趨勢，其二則聚焦在BPCIA新建立的核准前專利爭端解決程序下，生物相似性藥品面臨「專利舞蹈」時的法律評估及智慧財產權管理。 論文的第一部分係根據從各種市場研究報告收集、整理而成的統計數據，以系統性的方式深入介紹全球製藥產業，並分析生物相似性藥品的市場機會和潛在隱憂。另外此部分亦詳細說明了生物相似性藥品的生理活性、知識斷層與製程依賴性之間的關係、分析技術對生物產品做完整定性的不足以及生物相似性藥品的開發流程。 論文的第二部分則以討論BPCIA的重要條文規定為主，包括專利舞蹈制度和上市審查要求，諸如生物相似性之證明、可互換性之認定與適應症外推。其他相關議題，包含參考藥品的法定專屬權保護期長度、生物相似性藥品自動替換之立法化、專利資訊交換機制的可能濫用及原廠與生物相似藥廠達成反競爭協議之風險皆會予以進一步探討。除此之外，本部分也介紹了歐盟和台灣生物相似性藥品上市法規的沿革與現況。 本文試圖透過對生物相似性藥品的全方位綜合研究成果，提出可行的市場進入方案及善用專利和營業祕密優勢之智慧財產權保護佈局策略。 / Biologics represent many of the most promising novel therapies for previously deadly and intractable disease areas like cancer, autoimmune disease and neurological disorders. As discovery of breakthrough small-molecule drugs becomes more difficult, together with lower attrition rate and higher productivity of biologics in the new drug research and development (R＆D) process, pharmaceutical companies are increasingly turning to develop lucrative large-molecule biological products in recent years. In addition, the patents on numerous blockbuster biologics treatments will soon expire, bringing soaring demand for relatively inexpensive generic versions of originator biologics, generally known as “biosimilars.” However, due to contrasting characteristics and natural differences in terms of size and structural complexity between biologics and small-molecule drugs, it is necessary to create a regulatory pathway solely for biosimilars. As part of the Patient Protection and Affordable Care Act which was officially signed into law on March 23, 2010, the U.S. Congress passed the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is considered one of the more significant overhauls to the pharmaceutical industry, aiming to strike a proper balance among securing public interests, stimulating biotechnology innovation and controlling healthcare expenditure through competition. It established an abbreviated approval pathway for biosimilars modeled closely after the Hatch-Waxman Act’s approval process for generic chemical drugs. The structure of this thesis is divided into two major parts, of which the first part provides an overview of pharmaceutical industry and trends in the global biologics market, whereas the second part focuses on the legal assessment and intellectual property management of biosimilars under BPCIA’s new pre-approval patent dispute resolution process, the “patent dance”. The first part starts from the in-depth systematic introduction of global pharmaceutical industry based on statistics collected from various market research reports, then analyzes the market opportunities and potential concerns for biosimilars. Moreover, this part illustrates the physiological properties, the relationship between “knowledge gap”and manufacturing path-dependence, the insufficieny of analytical techniques in fully characterizing biological products, and the development process of biosimilars in details. The second part discusses key provisions of the BPCIA, including the patent dance procedures and regulatory requirements, such as demonstrating biosimilarity, interchangeability and extrapolation. Other relevant issues include the length of statutory exclusivities granted to reference products, legislations on biosimilar automatic substitution, potential abuses of patent information exchange mechanism and risks of reaching anti-competitive agreements between pioneers and biosimilar manufacturers will be further discussed. Besides, this part describes the timeline and status quo of EU and Taiwan’s biosimilar approval regulations. With comprehensive study on multiple aspects of biosimilars, this article tries to propose feasible market access plans and robust intellectual property protection strategies capitalizing upon patents and trade secrets.