lawpalyer logo
in判決書

臺灣臺北地方法院101年度金訴字第9號

關鍵資訊

  • 裁判案由
    證券交易法
  • 案件類型
    刑事
  • 審判法院
    臺灣臺北地方法院
  • 裁判日期
    102 年 04 月 24 日

       1019           100 2614 4121VDE FDA FDA FDA 966 調FDA 96102225961029111 483 2 483 FDA 調96112930FDA 973 28FDA 9610117 Center for Devices and Radiological and Health CDRHWarning Letter973 31FDA Current Good Manufacturing Practice CGMPadulterated FDA detention without physical examination 15FDA FDA 974 1 FDA FDA 483 FDA FDA FDA483調974 10349866974 12974 15使974 17122 4 181,365 218 25620 29210 5 2,325 53.3% 974 18FDA FDA FDA FDA 975 276 30FDA 976 116 1318.56 1617.617.35 977 1296退53.22%49.46%45.64%45.30%76.55%64.78%9796 40.21%970.59962.26退976 121017.865 2,325 6,916 6,800 2,732 4,612 調調 982 260000000000A66-18便976 270000000000A670-77 100 121 0000000000A1382-383 8 3032-35 159 1 159 1 159 4 調159 1 159 5 982 260000000000便976 270000000000100 121 0000000000 2 1.43% 9720% 13000 FDA 94 FDA 172007FDA 5 94175 2.974 2 FDA 4 18FDA 6 2 FDA 5 2730FDA FDA FDA 4 2 6 11 3.4 2 6 114 2 8997FDA 300 969 FDA 調672 5 FDA FDA 1.157 1 5 974 2 FDA 976 11FDA 2 FDA 2.FDA informal advisory FDA FDA FDA FDA 15使FDA FDA FDA FDA FDA 3.FDA FDA 976 11FDA FDA FDA 1.15711 5 FDA 9698FDA 138117FDA FDA 1.23% FDA CDRH Detention FDA FDA FDA 2.FDA FDA FDA FDA FDA 7 FDA 7 FDA FDA 15FDA 4 18FDA FDA 975 27Import Alert975 27FDA FDA FDA FDA FDA FDA FDA 973 28FDA 3.157 1 996 materiality 974 1.157 1 1 981358使 2.969 1 9610973 973 FDA 調A121147-150 925 6 9212128 A175-76 9193985 1100000000000 A4163-183 96A4111 VDE FDA 調A11-3 調FDA A221-22 調9697A414 FDA 調96974555A122FDA FDAFDAA2149 96A6123 FDA 966 FDA 961011483 2 483 FDA 調96112930FDA A122調A21994-96 FDA 966 A139-39 FDA A912-18 FDA 483 A919-19 FDA 483 A920-21 A922-23 A924-26 973 28FDA 961011973 31FDA 974 1 FDA A122297-298 調A296FDA 973 28A6106-110 A9139 FDA 286-291 974 調FDA 973 28974 l 974 2 A42 4 2 1515A122調FDA warning letter974 FDA warning letter973 244 l 2158FDA warning letter974 2 warning letterl A2967 FDA A220 974 10349866使974 17292,325 1.4 4 974 124 124 104 10A1227 7 227- 228 2.973 284 l 3 3 2831 4 l 974 2000A1297 7 229-231 3.調A243-44 調A273-75 A6149-189 200 A454-57 A619-22 A1320-329 4.973 28974 7 974 10973 7 163 168 5.973 974 18FDA FDA FDA FDA 975 276 30FDA 976 11 1.調A2149 A122調A220-21 96-97 7 76 2.974 18A927-32 FDA 975 27A933-34 FDA 975 27A9148-148 Forwarder A9157-158 97FDA A967-122FDA Import Alert 89-04 Red List292 293 302 A847976 12A1 389 976 12退調497 2退 97A2150 調40% 40% A297977 12A1390-395 97A1396 972 981 6 16-17 K 6 26-27 148 973 6 974 10 1.157 1 1 996 2 157 1 5使157 1 1 5 951 114 使5 14-15 157 1 4 157 1 996 2 6 4 991222157 1 5 6 157 1 2.西 3. 2 15185 24-26 4 2 5 3 5 26 157 1 996 99122298115 986492996 157 1 1 5 12- 13996 996 4.SEC v. Texas Gulf Sulphur Co.1 1988Basic, Inc. v. Levinson 2 the probability / magnitude trade-off Basic Rule 10b-5Rule 10b-53 Basic TSC Industries,Inc. v. Northway, Inc.reasonable4 Basic 193410b Rule10b-5 TSC 5 TSC preliminary merger discussionsTSC speculative 6 SEC v.Texas GulfSulphur Co. 7 Rule 10b-58 Basic address Hiler 9 Hiler TSC 10SEC reliability of information basedon subjective judgments 使11Hiler Hiler 調12investor-oriented 13157 1 5 Basic 148 243-244 255-259 1.FDA 483 FDA FDA 15FDA 調974 18稿17184 1718FDA FDA FDA A2 20 2.FDA FDA483調 3.調Detention Jim 9611FDA483974 HomedicsJim CarponA43-4 調FDA 稿Jim CarponA225FDA Jim CarponHoMedicsHoMedics Jim Carpon7 82Jim CarponA228-31 4.使Jim Carpon 5.使FDA 7 67-89 調FDA 965 27調a.b.c. CAPA調FDA FDA FDA FDA A2977 81FDA FDA 滿FDA 7 7678 6.7 7.976 1318.56 1617.617.35 退 1.FDA Regulatory Procedures ManualFDA FDA 使5 27FDA FDA FDA 2.FDA FDA FDA FDA FDA FDA 1 3 5 may lead to "detention without physical examination," FDA given the serious nature of the violations of the Act FDA serious nature serious 8 5-11 FDA CDRH FDA 95441110detention detaining 9647119 9756189597CDRH40375 157 8 76 FDA CDRHFDA 9597111118FDA given the serious nature of the violations of the Act 3.FDA FDA FDA Import AlertFDA Import AlertFDA Import AlertFDA Import Alert8 8-9 FDA detention FDA Import Alert5 41 FDA FDA detention order order 7 78 FDA FDA FDA FDA 975 27FDA 973 284 159 FDA 975 2730FDA 976 11FDA 調4 183-185 4.FDA 9698 FDA 138117FDA FDA 1.23% 8 134-179 FDA 1381FDA FDA FDA FDA Import Alert 89-04Red ListFDA Import Alert8 180-185 FDA Import Refusal Report 8 439597CDRH40 Import Refusal Report 13FDA 8 186-202 139 135-139 FDA CDRH1.23% 5. 1.996 2 157 1 1 189711265 3 2. 91 3037157 1 1 The Knowing Possession Test 使The Use Requirement仿 equal excess to information fiduciary relationship misappropriation theory Disclose or Abstain Rule SEC in possession of Rule 10b5-1 15 969 FDA 7 174-185 A1437-457 1.973 973 7 973 114 33A1312-313 7 228 973 2.977 8 4 34-36 974 10 3.974 10 2 1 157 1 1 171 996 2 996 4 1 1 1 5 2 1 171 996 2 101 1 4 996 2 974 10974 17292,325 996 2 157 1 1 171 1 1 5 2,325 2,732 4,612 499 6,665 996 2 1716 171 1 2 171 2 1 7 2 5 5 934 282 1 984800- 200910558 2,732 4,612 157 1 1 103 157 1 3 967644157 1 1 1 101 907 499 6,665 4 202-204 2,232 7,947 299 1 996 2 157 1 1 1 171 1 1 6 2 1 11 102 4 24 10 102 4 24 99621571 使 滿 滿 9962171 使 FDA FDA 973 28FDA 973 28FDA 975 27FDA 975 27 0 2,325 69,166,8002,325 976 121017.86598,563207,500 2,732 4,612 69,166,800 X 10 -2,325,000 X 17.865 = 27,630,675 69,166,800 = X 0.001425 98,563 = X 0.003 207,500 27,630,675 -98,563 -207,500 =27,324,612 27,324,612 -4,996,665 =22,327,947 1.0.001425 2. 973976 A1 1002614 A2 995929 A3 991110 A4 調調100.1.20 A5 調調100.1.20 A6 調調99.7.20 A7 調調99.7.20 A8 調調99.6.10 A9 調調99.6.10