Case 3:18-cr-00527-WHA Document 1 Filed 10/25/18 Page 1 of 28 I0ts;ti1ct Court FOR THE NORTHERN DISTRICT OF CALIFORNIA VENUE: SAN FRANCISCO UNITED STATES OF AMERICA, V. DR 18 XANTHE LAM. ALLEN LAM, JOHN CHAN, and JAMES QUACH, FILED OCT 2 5 201B u 8USAN Y. SOONa CLERtC U.8. DISTRICT COURT NORTH DISTRICT OF CALIFORNIA OAKLAND OFFICE DEFENDANT{S). INDICTMENT 18 U.S.C. § 1832(a)(5) - Conspiracy to Commit Theft of Trade Secrets 18 U.S.C. § 1832(a) - Theft of Trade Secrets 18 U.S.C. § 1030(b) - Conspiracy to Commit Computer Fraud and Abuse 18 U.S.C. § 1030(a)(2)(C) - Computer Fraud and Abuse 18U.S.C. §2-Aid&Abet 18 U.S.C. §§ 982, 1030, 1834, and 2323 - Criminal Forfeiture A true bill. Foreman Filed in open court this day of Clerk [k]i BjijnS. NO BAIL WARRANT xr 1 Case Document 1 Filed 10/25/18 Page 2 of 28 A0 257 (Rev. 6/78) I DEFENDANT INFORMATION RELATIVE TO A CRIMINAL ACTION - IN U.S. DISTRICT COURT BY: COMPLAINT INFORMATION INDICTIVIENT CHARGED SUPERSEDING Name of District Court, andtor JudgetMagistrate Location NORTHERN DISTRICT OF CALIFORNIA See Attached PROCEEDING 18 U.S.C. I832(a)(5} A Conspiracy to Commit Then of Trade Petty Secrets; 18 U.S.C. 1832(a] Theft of Trade Secrets: 18 U.S.C. 103003) Conspiracy to Commit Computer Fraud Mlnor and Abuse: 18 U.S.C. Computer Fraud and . Abuse; 18 U.S.C. 2 Aid and Abet; 18 U.S.C. 982, 1030, I: M'Sde' 1834, and 232303) Criminal Forfeiture. mean? Felony SAN FRANCISCO DIVISION DEFENDANT - U.S XANTHE LAM sierra; win I DEFENDANT IS NOTIN CUSTODY Name of Complaintant Agency. or Person Title, if any) FEDERAL BUREAU OF INVESTIGATION person is awaiting trial in another Federal or State Court. give name of court this persontproceeding is transferred from another district per (circle one) 20, 21, or 40. Show District this is a reprosecution of charges previously dismissed CI which were dismissed on motion SHOW of DOCKET NO U.S. ATTORNEY DEFENSE this prosecution relates to a pending case involving this same defendant MAGISTRATE before U.S. Magistrate regarding this CASE NO prior proceedings or appearance(s) defendant were recorded under Has not been arrested, pending outcome this proceeding. 1) If not detained give date any prior summons was served on above charges 2) Is a Fugitive 3) [3 Is on Bail or Release from (Show FEEL) IS IN CUSTODY OCT 25 2013 4) On this charge USAN Y.S SOON DlgTa NOR are 5) On another conviction niawgngI-IFOHNM ICE State 6) Awaiting trial on othercharges If answer to (6) is "Yes". show name Of institution Has detainer Yes If. Yes been ?led? No tag: date DATE OF ARREST if Arresting Agency 8- Warrant were not Name and Of?ce of Person Furnishing Information on this form ALEX G. TSE DATE TRANSFERRED Month/DayI?Year TO U.S. CUSTODY U.S. Attorney Other U.S. Agency Name of Assistant U.S. MAW-HEW PARRELLA Attorney (if assigned) MICHELLE J. KANE I PROCESS: SUMMONS CI NO WARRANT If Summons, complete following: Arraignment Initial Appearance Defendant Address: Comments: ADDITIONAL INFORMATION OR COMMENTS This report amends A0 25? previously submitted Bail Amount: NO BAIL Where defendant previously apprehended on complaint, no new summons or warrant needed, since Magistrate has scheduled arraignment Date/Time: Before Judge: . Case Document 1 Filed Page 3 of 28 I ATTACHMENT Statutory Maximum Penalties: Counts 1 and 28 (18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade Secrets): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Counts 2-27, 29-32 (18 U.S.C. 1832(a) and 2 Theft of Trade Secrets, Aid and Abet): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Count 33 (l 8 U.S.C. 1030(b) Conspiracy to Commit Computer Fraud and Abuse): Five years of imprisonment; $250,000 fine, three years of supervised release, $100 special assessment, forfeiture. Counts 34-36 (18 U.S.C. 1030(a)(2)(C) and 2 Computer Fraud and Abuse, Aid Abet): Five years of imprisonment; $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Case Documentl Filed 257 (Rev. ens) I DEFENDANT INFORMATION RELATIVE TO A CRIMINAL ACTION - IN U.S. DISTRICT COURT BY: I: COMPLAINT INFORMATION INDICTMENT Name of District Court. andfor Judgei'Magistrate Location OFFENSE CHARGED SUPERSEDING NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION 13 U.S.C. Conspiracy to Commit Theft ofTrade Petty Secrets; . 18 use ofTrade Secrets; Mmor DEFENDANT - us 18 U.S.C. 2 Aid and Abet; Misde- 18 U.S.C. 982, 1834, and 232303) Criminal Forferture. meanor ALLEN LAM Felon DISTRICT COURT NUMBER PENALTY: See Attached CR 18 527? WHA DEFENDANT PROCEEDING IS NOTIN CUSTODY . . . Has not been arrested, pending outcome this proceeding. Name of Complaintant Agency, or Person Title, If any) 1) If not detained give date any prior FEDERAL BUREAU OF INVESTIGATION summons was served 0? above Charges person is awaiting trial in another Federal or State Court, 2) is a Fugitive give name of court 3) Is on Bail or Release from (show CI this personfproceeding is transferred from another district per (circle one) 20, 21. or 40. Show District IS IN CUSTODY 25 2018 4) On this charge SUSAN Y. SOONG . . . CLERK. U.S. DISTRICT COURT this Is a reprosecutIon of NORTH DISTRICT OF CALIFORNIA charges previously dismissed 5) I: On another conviction OAKLAND OFFICE CI which were dismissed on motion SHOW Federal )3 State of: DOCKET NO. 6) Awaiting trial on othercharges E) US. ATTORNEY DEFENSE If answer to (6) Is "Yes", show name of Institution this prosecution relates to a .. .. pending case involving this same Has detainer Yes givzedsate defendant MAGISTRATE been ?led? No ?ied CASE NO. prior proceedings or appearance(s) DATE OF . Montthany ear before US. Magistrate regarding this ARREST defendant were recorded under if Arresting Agency Warrant were not Name and Of?ce of Person DATE TRANSFERRED MONIWDEWY ear Furnishing Information on this form ALEX G.TSE TO US. CUSTODY US. Attorney Other US. Agency Name of Assistant US. MAW-H EW A- This report amends A0 257 previously submitted Attorney (if assigned) MICHELLE J. KANE ADDITIONAL INFORMATION OR COMMENTS PROCESS: [j SUMMONS E) NO WARRANT Bail Amount: NO BAIL If Summons, complete following: Arraignment Initial Appearance Defendant Address: Where defendant pre vr'ously apprehended on complaint, no new summons or warrant needed, since Magistrate has scheduled arraignment Date/Time: Before Judge: Comments: Case Document 1 Filed 10/25/18 Page 5 of 28 A f? ATTACHMENT Statutorv Maximum Penalties: Count 1 (18 U.S.C. 1832(a)(5) Conspiracy to Commit The? of Trade Secrets): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Counts 2-27 (18 U.S.C. 1832(a) and 2 Theft of Trade Secrets, Aid and Abet): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Documentl Filed Page60f 28 A0 25? ~{Rev. 6178) ML. DEFENDANT INFORMATION RELATIVE TO A CRIMINRE A5 I ION - IN U.S. DISTRICT COURT INDICTMENT CI SUPERSEDING BY: COMPLAINT INFORMATION OFFENSE CHARGED 18 1832(a)(5) Conspiracy to Commit Theft of Trade Petty Secrets: . 18 U.S.C. 1832(a) Theft of Trade Secrets; Minor 18 U.S.C. 2 ?Aid and Abet; 18 U.S.C. 982, 1834, and 2323(b) Criminal Forfeiture. El '5 e' meanor Felony See Attached PROCEEDING Name of Compiaintant Agency. or Person (8 Title, if any) FEDERAL BUREAU OF INVESTIGATION person is awaiting trial in another Federal or State Court, CI give name of court this personlproceeding is transferred from another district per (circle one) 20. 21, or 40. Show District this is a reprosecution of charges previously dismissed which were dismissed on motion SHOW of DOCKET NO '1 US. ATTORNEY DEFENSE this prosecution relates to a pending case involving this same Name of District Court. andior JudgeiMagistrate Location NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION DEFENDANT - U.S JOHN CHAN DISTRICT COURT NUMBER CR 18 527 WHA defendant MAGISTRATE CASE NO. prior proceedings or appearance(s) before US. Magistrate regarding this defendant were recorded under Name and Of?ce of Person Furnishing Information on this form ALEX G. TSE EUS. Attorney Other US. Agency MATTHEW A. PARRELLA MICHELLE J. KANE Name of Assistant US. Attorney (if assigned) PROCESS: SUMMONS NO WARRANT If Summons, complete following: Arraignment Initial Appearance Defendant Address: Comments: DEFENDANT IS NOT IN CUSTODY Has not been arrested. pending outcome this proceeding. 1) If not detained give date any prior summons was served on above charges 2) El Is a Fugitive 3) El Is on Bail or Release from (shF TEE OCT 25 2013 SUYSAN KNOSOO CLERK U. S. DISTRICTG coon-r NORTH diST STRICT OF OAKLAND oer-1c ALIFOFINIA 5) On another conviction Federal State 6) El Awaiting trial on other charges IS IN CUSTODY 4) On this charge If answer to (6) is "Yes". show name of institution Has detainer Yes been ?led? No DATE OF . ARREST If "Yes" give date ?led MonthiDain ear if Arresting Agency 8. Warrant were not DATE TRANSFERRED Month/Day/Year TO U.S. CUSTODY ADDITIONAL INFORMATION OR COMMENTS DatelTime: This report amends A0 257 previously submitted Bail Amount: N0 Where defendant previousiy apprehended on compiaint, no new summons or warrant needed, since Magistrate has scheduied arraignment Before Judge: Case Documentl Filed 10/25/18 Page7of 28 A A 1, ATTACHMENT Statutory Maximum Penalties: Count 1 (18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade Secrets): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Count 8 (18 U.S.C. 1832(a) and 2 Theft of Trade Secrets, Aid and Abet): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Case Documentl Filed 10/25/;8 A0 257 (Rev. ens) DEFENDANT INFORMATION RELATIVE TO A CRIMINAL ACTION - IN U.S. DISTRICT COURT BY: COMPLAINT INFORMATION INDICTMENT SUPERSEDING OFFENSE CHARGED 18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade I: Petty Secrets; 18 U.S.C. 1832(a) Theft of Trade Secrets; 18 U.S.C. 1030(b) Conspiracy to Commit Computer Minor Fraud and Abuse; 18 U.S.C. - Computer Fraud and Abuse; 18 U.S.C. 2 Aid and Abet;18 U.S.C. '3 e' 982, 1030, 1834, and 2323(b) Criminal Forfeiture. mean? Felony PENALTY: See Attached Name of District Court, andror JudgelMagistrate Location NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION DEFENDANT - U.S JAMES QUACH DISTRICT COURT NUMBER CR 18 527 WHA DEFENDANT PROCEEDING Name of Complaintant Agency. or Person Title, if any) FEDERAL BUREAU OF INVESTIGATION person is awaiting trial in another Federal or State Court, give name of court this person/proceeding is transferred from another district per (circle one) 20. 21, or 40. Show District this is a reprosecution Of charges previously dismissed which were dismissed on motion SHOW of DOCKET NO U.S. ATTORNEY El DEFENSE this prosecution relates to a pending case involving this same defendant MAGISTRATE CASE NO. prior proceedings or appearance(s) before U.S. Magistrate regarding this defendant were recorded under Name and Of?ce of Person Furnishing Information on this form ALEX G. TSE Attorney Other U.S. Agency MATTHEW A. PARRELLA MICHELLE J. KANE Name of Assistant U.S. Attorney (if assigned) PROCESS: SUMMONS El NO WARRANT If Summons. complete following: Arraignment Initial Appearance Defendant Address: Comments: IS NOTIN CUSTODY Has not been arrested. pending outcome this proceeding. 1) If not detained give date any prior summons was served on above charges 2) Is a Fugitive 3) Is on Bail or Release from (show ECTN 25 2018 OONG CLERK. u. s. NDIYSTRICT cou NORTHD DISTFII OF IS IN CUSTODY 4) On this charge 5) On another conviction Federal State 6) Awaiting trial on other charges if answer to (6) is "Yes", show name of institution Has detainer Yes been ?led? CI No ?led DATE OF . Montthaerear ARREST if Arresting Agency Warrant were not DATE TRANSFERRED Month/DayI'Year TO U.S. CUSTODY ADDITIONAL INFORMATION OR COMMENTS DatefTime: This report amends A0 25? previously submitted Bail Amount: NO BAIL Where defendant previousiy apprehended on complaint, no new summons or warrant needed, since Magistrate has scheduied arraignment Before Judge: Case Document 1 Filed 10/25/4?143 Page 9 of 28 ATTACHMENT Statutory Maximum Penalties: Count 28 (18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade Secrets): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Counts 29-32 (18 U.S.C. 1832(a) and 2 Theft of Trade Secrets, Aid and Abet): Ten years of imprisonment, $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Count 33 (18 U.S.C. 1030(b) Conspiracy to Commit Computer Fraud and Abuse): Five years of imprisonment; $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Counts 34-36 (18 U.S.C. 1030(a)(2)(C) and 2 Computer Fraud and Abuse, Aid Abet): Five years of imprisonment; $250,000 ?ne, three years of supervised release, $100 special assessment, forfeiture. Case Document 1 Filed 10/25138 Page 10 of 28 ALEX G. TSE (CABN 132612) United States Attorney UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION CASENO.CR 18 UNITED STATES OF AMERICA, V. VIOLATIONS: 18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade Secrets; 18 U.S.C. XANTHE LAM, 1832(a) Theft ofTrade Secrets; 18 U.S.C. 1030(b) ALLEN LAM, Conspiracy to Commit Computer Fraud and Abuse; 18 U.S.C. 1030(a)(2)(C) Computer Fraud and Abuse; 18 U.S.C. 2 Aid Abet; 18 U.S.C. 982, 1030, 1834, 2323 Criminal Forfeiture. SAN FRANCISCO VENUE JOHN CHAN, and JAMES QUACH, Defendants. I I The Grand Jury charges: INTRODUCTORY ALLEGATIONS The Victim Company: 1. Genentech, Inc. (?Genentech?) was a biotechnology corporation, established in 1976, whose principal place ofbusiness was South San Francisco, California. Genentech has been part ofthe Roche Group since March 2009. Genentech has been discovering, developing, manufacturing, and commercializing pharmaceutical therapies for more than 40 years. Genentech manufactured and commercialized biopharmaceuticals for a variety of medical conditions, including cancer, rheumatoid arthritis, heart attack, stroke, and others. INDICTMENT Case Document 1 Filed 10/2543 Page 11 of 28 Biopharmaceuticals or Biologics: 2. Biopharmaceuticals are a class of large-molecule drugs that are created using genetically- modi?ed living cells. Relevant to this indictment, Genentech has developed, manufactured, and marketed the following biopharmaceuticals, used in and intended to be used in interstate and foreign commerce: a. Pulmozyme (domase alfa), an inhalation treatment for cystic ?brosis. b. Rituxan (rituximab), for use in treating certain types of non-Hodgkin's and chronic leukemia. c. Herceptin (trastuzumab), for the treatment of certain metastatic breast cancers, as an adjuvant therapy for breast cancer, and for certain metastatic gastric cancers. (1. Avastin (bevacizumab), for the treatment of various cancers. Biosimilars: 3. Biosimilars are biopharmaceutical drugs designed to have active properties similar to a previously-approved drug roughly the equivalent of a ?generic? chemical drug. The Biologics Price Competition and Innovation Act, 42 U.S.C. 262, enacted in 2010, provides for abbreviated regulatory approval for biosimilars by letting applicants rely on the extensive clinical testing previously conducted by the innovator company that developed the medicine the applicant wants to copy. Other Entity: 4. HL Biotech, Inc. was founded in 2012 and is headquartered in Zhubei, Taiwan. It operates as a biopharmaceutical company worldwide. website states that HL provides cell line cloning, process development, and manufacturing capabilities and services to emerging and established biopharmaceutical companies seeking to collaboratively develop, manufacture and commercialize new, high-quality, affordable biologics. JHL was developing biosimilars of Genentech biopharmaceuticals including Pulmozyme, Rituxan, Herceptin, and Avastin. The Defendants: 5. XANTHE LAM Principal Scientist with Genentech. XANTHE LAM was employed by Genentech from 1986 until 2017. 6. ALLEN C. LAM XANTHE husband. He worked in Quality INDICTMENT 2 Case Document 1 Filed Page 12 of 28 Control at Genentech from 1989 to 1998. ALLEN LAM consulted for Genentech competitor HL from at least 2013 through 2014, and in 2017. 7. JOHN CHAN son of a friend of XANTHE XANTHE LAM helped CHAN obtain employment at Genentech and HL. CHAN worked at HL ?'om May 2014 to June 2017 as a Project Lead and Formulation Group Leader on Pulmozyme biosimilar project. 8. JAMES QUACH former Genentech engineer and former consultant for HL. Genentech Trade Secrets: 9. Genentech?s biopharmaceutical technology contained trade secrets, as de?ned in Title 18, United States Code, Section 1839(3), that were included in, and intended to be included in, products sold worldwide. Genentech?s biopharmaceutical technology included, but was not limited to, the following trade secrets: a. Pulmozyme Physiochemical Characterization Methods: Genentech has developed quality control methods and corresponding proprietary test procedures for determining the physiochemical properties of Pulmozyme, including, for example, its charge heterogeneity. These procedures are used by Genentech to ensure that their products meet the speci?cations approved by regulators. b. Stability Assays for Pulmozyme: Genentech has developed ?assays,? or proprietary analytical methods, to test and validate the stability of Pulmozyme. These methods are designed to ensure that the drug substance and ?nal drug product are stable and will remain so over time. These methods differ from publicly available guidelines. 0. Methyl Green Assay for Quantitating the Activity of Pulmozyme: Genentech developed a proprietary procedure for quantitating the activity of thnase (Pulmozyme) using a methyl green assay. Genentech?s procedure includes speci?cations for preparing the sample, sample preparation protocols, detailed instructions for running the test and for analyzing the results, and acceptance criteria. (1. Methyl Green Assay for Identifying Pulmozyme: Genentech developed a proprietary procedure for identifying Pulmozyme using a methyl green assay. INDICTMENT 3 Case Document 1 Filed 10/25m Page 13 of 28 e. Neutral Sugars in Pulmozyme: Genentech has developed detailed test procedures for determining the number of neutral sugars per known unit of Pulmozyme. Through research and development, Genentech has determined the acceptable range of neutral sugars based on historical results from its test procedures. f. Use of Stedim Bags: Genentech has invested signi?cant time in deve10ping and running proprietary tests to determine the suitability of single-use bio process bags, also known as ?Stedim? bags for storage of Pulmozyme. Genentech?s research, which it has maintained con?dential, reveals how to best test for chemical, physical, and biological stability when the drug is stored in stedim bags, including the chromatographic, spectroscopic, and pH analyses performed and the results of those analyses. g. Methods for Assessing the Stability of Pulmozyme: Genentech has developed speci?c test procedures, detailed instructions for preparing the samples, to evaluate the stability of its Pulmozyme drug product and to ensure that the product remains stable over the course of its lifecycle. Genentech's procedures include methods for simulating various stress conditions in order to ensure that its array of assays adequately detect various levels of degradation in its drug product. h. Excipient Assays for Rituxan: Genentech has developed proprietary analytical methods to test and validate the total solute concentration (the amount of solutes/particles dissolved in a solution) of ions and nonionized molecules in Rituxan. i. Purity Assays for Rituxan: Genentech has developed certain proprietary assays to determine the purity of Rituxan, including step-by-step instructions for conducting those assays and the expected results for those tests. j. Quality Assays for Rituxan: Genentech has developed a set of speci?c assays and corresponding speci?cations to assure the quality of Rituxan. k. Peptide Mapping for Rituxan: Genentech has developed a certain proprietary assay to determine the ??ngerprint? of the protein in Rituxan through peptide (short chains of amino acid molecules) mapping, including step-by-step instructions for conducting those assays and the. expected results. INDICTMENT 4 AWN Case Document 1 Filed 10/251143 Page 14 of 28 l. Glycan Assays for Rituxan: Through research and development, Genentech has developed certain proprietary assays to best determine the glycosylation (when a carbohydrate is attached to a functional group of another molecule) of Rituxan, including step-by-step instructions for conducting those assays and the expected results for those tests. m. DNA Sequence: The DNA sequence for one of Genentech's proprietary monoclonal antibody (antibodies that are made by identical immune cells that are all clones of a unique parent cell) in development. n. Excerpts of Genentech's BLA Submission for Rituxan: Genentech submitted a Biologics License Application for Rituxan to the FDA, which maintains con?dentiality during the application process. That submission contained Genentech's con?dential trade secrets concerning the manufacture of Rituxan and included its drug substance and drug product speci?cations and analytical methods, as well as its in-process quality control methods. 0. Identity Assays for Herceptin: Genentech has developed certain assays to study the identity of Herceptin. These include speci?c test and validation protocols and procedures, drug substance and drug product speci?cations, and acceptance criteria Genentech used for assessing the identity of Herceptin, as well as proprietary information on the physical and chemical characteristics of Herceptin. p. Purity Assays for Herceptin: Genentech has developed certain proprietary assays to determine the purity of Herceptin, including step-by-step instructions for conducting those assays and the expected results for those tests. q. Stability Assays for Herceptin: Genentech has developed proprietary analytical methods to test and validate the stability of Herceptin. These methods are critical to ensuring that the drug substance and ?nal drug product are stable and will remain so over time. r. Assays to Assure Herceptin quality: Through research and development, Genentech has developed a set of speci?c assays to test for the key quality attributes of its Herceptin drug products. 3. Identity Assays for Avastin: Genentech has developed certain assays to study the identity of Avastin. These include Genentech's speci?c test and validation protocols and INDICTMENT 5 Case Document 1 Filed 10/251143 Page 15 of 28 procedures, drug substance speci?cations, and acceptance criteria, which are used for assessing the identity of Avastin, as well as proprietary information on the physical and chemical characteristics of Avastin. t. Sterility Test Procedures for Genentech Products: Genentech has developed proprietary test procedures to test the sterility of its products, including by detecting the presence of viable bacteria, fungi, or yeast. u. Out-of-Speci?cation Requirements: Genentech has developed requirements and step-by-step procedures based on regulatory guidelines for how to investigate, evaluate, and take action on out-of-speci?cation test results of investigational medicinal products and commercial material, and how to ensure compliance with applicable regulatory requirements. Genentech also developed instructions for the assessment and closure of out-of-speci?cation discrepancies, including in-process reject limit excursions. These procedures and requirements allow Genentech to ensure compliance with applicable regulatory requirements. v. Good Documentation Practices: Genentech has developed documentation practices for Good Manufacturing Practices at its manufacturing facilities. These detailed practices and procedures provide a comprehensive roadmap for a biopharmaceutical manufacturer seeking to set up, establish and validate procedures and processes in its manufacturing facilities, as well as satisfy regulatory requirements in audits or inspections for approval to market biopharmaceutical products. w. Raw Material Management: Genentech has developed policies and procedures relating to the management of raw materials, including quality systems for managing the receipt, identi?cation, storage, handling, control, movement, sampling, dispensing, distribution, and release of raw materials. The proper management of raw materials is critical to the manufacturing process, and requires extensive and time-consuming research and testing to assure the quality of materials used in manufacturing. x. Procedures to Assure Quality Control: Through research and development, Genentech has developed a speci?c and detailed procedure for the inspection of small-volume parenterals, that is, drugs administered particularly intravenously or by injection, as part of their IN DICTMENT 6 AWN Case Document 1 Filed Page 16 of 28 quality control system. This procedure differed from publicly available guidance through the USP Reference Standards. The step-by-step instructions contained in the procedure allow Genentech to be compliant with the regulatory standards. y. Qualitative Appearance of Liquid Samples and Lyophilized Vials: Genentech has developed detailed methods for determining qualitatively the clarity, degree of opalescence, and degree of coloration of liquid samples of lyophilized, or ?freeze-dried,? vials. 2. Manufacturing Protocols for Preventing Contamination: Genentech developed, re?ned, and implemented numerous manufacturing protocols to ensure the high quality of its drug substances and drug products for preventing surface contamination. These protocols include instructions for selecting surfaces that will come in contact with biologics, testing the surfaces, and documenting the tests. They also outline detailed instructions for cleaning biochemical manufacturing and cell banking areas in order to meet regulatory standards. aa. Manufacturing Protocols to Maintain Equipment: Genentech developed, re?ned, and implemented numerous manufacturing protocols to ensure the high quality of its drug substances and drug products by maintaining properly functioning equipment. As part of its process to optimize equipment function, Genentech developed a custom-made calibration station and developed detailed instructions for proper operation and calibration. Genentech's con?dential protocols also include step-by-step instructions for qualifying and validating equipment, maintaining the quali?ed state, and decommissioning equipment. The instructions help Genentech prevent product failures or unnecessary shut-downs. bb. Manufacturing Protocols to Maintain a Sterile Environment: Genentech developed, re?ned, and implemented numerous manufacturing protocols to ensure the high quality of its drug substances and drug products through the maintenance of a sterile environment. Genentech did so by standardizing procedures to control for such conditions as airborne particulate, microorganisms, and air?ow. These procedures include step-by-step instructions for conducting automated ?lter integrity testing and tests using HEPA (High- Ef?ciency Particulate Arrestor) ?lters, including the parameters for testing ?lter functions, a ?troubleshooting guide? with a list of common problems and corresponding corrective actions, IN DICTMENT 7 Case Document 1 Filed 10/25/43 Page 17 of 28 schematics showing how to set up the ?lters, and instructions for replacing ?lters, documenting the results of tests, and ensuring that ?lters are supplying air appropriately to work areas. cc. Manufacturing Protocols to Maintain Facilities: Genentech developed, re?ned, and implemented numerous manufacturing protocols to ensure the high quality of its drug substances and drug products by maintaining properly ?inctioning facilities. These protocols include Genentech?s processes for shutting down and restarting manufacturing facilities and utilities, including instructions for shutting down and restarting water systems, compressed gasses, steam, heating, ventilation, and air-conditioning, and other environmentally controlled GMP areas, as well as instructions for testing utility systems. dd. Manufacturing Protocols to Manage Risks: Genentech developed, re?ned, and implemented numerous manufacturing protocols to ensure the high quality of its drug substances and drug products through the identi?cation and mitigation of risks. These con?dential protocols represent Genentech?s process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle. They include Genentech's global standards for process validation throughout the product lifecycle, which covers execution, documentation, and deviation management, as well as Genentech's requirements for determining and verifying product speci?cations to ensure consistency. These protocols also include Genentech's quality testing standards to ensure Genentech is in compliance with regulatory requirements. ee. Manufacturing Protocols to Ensure Product Purity: Genentech developed, re?ned, and implemented numerous manufacturing protocols to ensure the high quality of its drug substances and drug products by preventing contamination through the drug lifecycle. These con?dential protocols lay out the strategy, requirements, and activities necessary to validate the sterility of the drug product process, including by maintaining sterile work areas. COUNT ONE: (18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade Secrets) 10. The factual allegations contained in Paragraphs 1 through 9 are realleged and incorporated as if fully set forth here. INDICTMENT 8 Case Document 1 Filed 10/25/48 Page 18 of 28 11. Beginning in approximately 2012 and continuing to at least October 2017, in the Northern District of California and elsewhere, the defendants XANTHE LAM, ALLEN LAM and JOHN CHAN, together with others known and unknown to the Grand Jury, intending to convert a trade secret that was related to a product and service used in and intended for use in interstate and foreign commerce to the economic bene?t of someone other than the owner of that trade secret, and knowing and intending that the offense would injure the owner of that trade secret, conspired: a. knowingly to steal, and without authorization appropriate, take, carry away, conceal, and by fraud, arti?ce, and deception obtain trade secrets belonging to Genentech; b. knowingly and without authorization to copy, duplicate, sketch, draw, download, upload, alter, photocopy, replicate, transmit, deliver, send, communicate, and convey trade secrets belonging to Genentech; and c. knowingly and without authorization to receive, buy, and possess trade secrets belonging to Genentech, knowing the same to have been stolen and appropriated, obtained, and converted without authorization. Manner and Means of the ConspiracV 12. Defendants and others conspired to steal, as prohibited by 18 U.S.C. trade secrets from Genentech and use them to create biosimilars of Genentech biologics, primarily at HL Biotech To accomplish this, XANTHE LAM and ALLEN LAM communicated with HL employees, many of whom were former Genentech employees, to facilitate the transfer of Genentech?s proprietary analytical methods for ensuring drug safety and ef?cacy; processes for formulating and testing its products for quality assurance; and procedures and protocols for setting up, calibrating, and maintaining manufacturing equipment and facilities. 13. Since inception as a company, its founders solicited XANTHE LAM and ALLEN LAM to help HL develop biosimilars designed to compete directly with Genentech?s products Rituxan, Pulmozyme, Herceptin, and Avastin. ALLEN LAM agreed to serve as a consultant for HL in 2013 in exchange for fees and founder stock options. XANTHE LAM, while still employed by Genentech, INDICTMENT 9 Case Document 1 Filed 10/2538 Page 19 of 28 secretly began working directly for HL by transferring Genentech trade secrets to ALLEN LAM for use by HL. 14. In December 2013, XANTHE LAM spent four weeks at JHL facilities in Taiwan without informing or obtaining approval from any appropriate manager at Genentech. In fact, when XANTHE LAM found out that a former Genentech supervisor would be in attendance with XANTHE LAM at opening ceremony, XANTHE LAM speci?cally requested one of founders to not disclose that she was at HL ?for formulation development, otherwise people at [Genentech] will know.? During her time at JHL, XANTHE LAM had her Genentech-issued laptop with her, thereby allowing her to access Genentech?s password-protected document repository. 15. Upon XANTHE return from JHL, she continued downloading, collecting, and transferring Genentech con?dential documents relating to formulation development and raw material management in order to assist ALLEN LAM with his consulting assignments at HL. In early 2014, XANTHE LAM caused family friend CHAN to be hired by JHL to work on formulation development. CHAN was hired in February 2014 after a JHL founder asked XANTHE LAM to conduct a formal interview of CHAN, with the understanding that XANTHE LAM would be his direct supervisor. Subsequently from May 2014 until November 2016, XANTHE LAM and CHAN spoke nearly every week. During this time, XANTHE LAM provided a Genentech con?dential document to CHAN through ALLEN LAM with the explicit instructions: ?don?t show it to others.? 16. Until XANTHE employment termination in the fall of 2017, she continued to download and provide Genentech proprietary information to HL. Overt Acts 17. In furtherance of the conspiracy and to effect its objects, in the Northern District of California and elsewhere, the defendants committed, among others, the overt acts alleged in Counts 2 through 27, below. 1 All in violation of Title 18, United States Code, Section l832(a)(5). INDICTMENT 1 0 Case Document 1 Filed 10/25/343 Page 20 of 28 COUNTS TWO THROUGH TWENTY-SEVEN: (18 U.S.C. 2 Theft of Trade Secrets; Aiding and Abetting) 18. The factual allegations contained in Paragraphs 1 through 17 are realleged and incorporated as if ?illy set forth here. 19. On the dates set forth below, in the Northern District of California and elsewhere, the defendants listed in the separate counts below, together with others known and unknown to the Grand Jury, intending to convert a trade secret that was related to a product and service used in and intended for use in interstate and foreign commerce to the economic bene?t of anyone other than the owner of that trade secret, and knowing and intending that the offense would injure the owner of that trade secret, as speci?cally alleged in each of the Counts 2 through 27 below: a. knowingly stole, and without authorization appropriated, took, carried away, concealed, and by fraud, arti?ce, and deception obtained trade secrets belonging to Genentech; b. knowingly and without authorization copied, duplicated, sketched, drew, downloaded, uploaded, altered, photocopied, replicated, transmitted, delivered, sent, communicated, and conveyed trade secrets belonging to Genentech; and c. knowingly and without authorization received, bought, and possessed trade secrets belonging to Genentech, knowing the same to have been stolen and appropriated, obtained, and converted without authorization: COUNT DATE ACTION TRADE SECRET 2 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Pulmozyme laptop Physiochemical Characterization Methods 3 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Stability Assays for laptop Pulmozyme 4 Dec. 23, 2013 XANTHE LAM, Email from XANTHE Methyl Green Assay for ALLEN LAM LAM to ALLEN Quantitating the Activity LAM of Pulmozyme 5 an.7, 2014 ALLEN LAM Email from ALLEN Methyl Green Assay for LAM to HL Quantitating the Activity of Pulmozyme 6 Dec. 23, 2013 XANTHE LAM, Email from XANTHE Methyl Green Assay for ALLEN LAM LAM to ALLEN Identifying Pulmozyme LAM INDICTMENT 1 1 Case Document 1 Filed 10/25/118 Page 21 of 28 COUNT DATE ACTION TRADE SECRET 7 Jan. 9, 2014 XANTHE LAM, Email from XANTHE Neutral Sugars in ALLEN LAM LAM to ALLEN Pulmozyme LAM 8 Sept. 28, 2014 XANTHE LAM, Email from XANTHE Use of Stedim Bags ALLEN LAM, and LAM to ALLEN JOHN CHAN LAM 9 May 12, 2015 XANTHE LAM, Email from XANTHE Methods for Assessing the ALLEN LAM LAM to ALLEN Stability of Pulmozyme LAM 10 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Excipient Assays for laptop Rituxan 11 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Purity Assays for Rituxan laptop 12 Sept. '22, 2017 ALLEN LAM Possessed on ALLEN Quality Assays for laptop Rituxan 13 Sept. 22, 2017 XANTHE LAM, Emails ?'om Peptide Mapping for ALLEN LAM XANTHE LAM to Rituxan ALLEN LAM Possessed on ALLEN laptop 14 Sept. 22, 2017 XANTHE LAM, Emails from Glycan Assays for ALLEN LAM XANTHE LAM to Rituxan ALLEN LAM Possessed on ALLEN laptop 15 Sept. 22, 2017 XANTHE LAM, Emails from DNA Sequence ALLEN LAM, XANTHE LAM to ALLEN LAM Possessed on ALLEN laptop 16 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Excerpts of Genentech's laptop BLA Submission for Rituxan 17 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Identity Assays for laptop Herceptin 18 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Purity Assays for laptop Herceptin 19 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Stability Assays for laptop Herceptin 20 May17, 2014' XANTHE LAM, Email ??om XANTHE Assays to Assure ALLEN LAM LAM to ALLEN Herceptin Quality LAM 21 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Identity Assays for laptop Avastin 22 Sept. 22, 2017 ALLEN LAM Possessed on ALLEN Sterility Test Procedures laptop for Genentech Products 23 Sept. 3, 2014 ALLEN LAM Email from ALLEN Out-of-Speci?cation LAM to ALLEN Requirements LAM TNDICTMENT 12 Case Document 1 Filed 10/2573 Page 22 of 28 COUNT DATE DEF ACTION TRADE SECRET 24 April 16, 2014 XANTHE LAM, Email from XANTHE Good Documentation ALLEN LAM LAM to ALLEN Practices LAM 25 Feb.l3 to XANTHE LAM, Emails from Raw Material April 21, 2014 ALLEN LAM XANTHE LAM to Management ALLEN LAM 26 July 3, 2014 XANTHE LAM, Email from XANTHE Procedures to Assure ALLEN LAM LAM to ALLEN Quality Control LAM 27 Sept. 17, 2014 ALLEN LAM Email from ALLEN Qualitative Appearance of LAM to himself Liquid Samples and Lyophilized Vials Each in violation of Title 18 United States Code, Sections 1832(a)(1), (2), (3), and 2. COUNT TWENTY-EIGHT: (18 U.S.C. 1832(a)(5) Conspiracy to Commit Theft of Trade Secrets) 20. The factual allegations contained in Paragraphs 1 through 19 are realleged and incorporated as if fully set forth here. 21. Beginning in July 2017 and continuing to at least September 2017, in the Northern District of California and elsewhere, the defendants XANTHE LAM and JAMES QUACH, together with others known and unknown to the Grand Jury, intending to convert a trade secret, that was related to a product and service used in and intended for use in interstate and foreign commerce, to the economic bene?t of anyone other than the owner of that trade secret, and knowing and intending that the offense would injure the owner of that trade secret, conspired: a. knowingly to steal, and without authorization appropriate, take, carry away, conceal, and by fraud, arti?ce, and deception obtain trade secrets belonging to Genentech; b. knowingly and without authorization to copy, duplicate, sketch, draw, download, upload, alter, photocopy, replicate, transmit, deliver, send, communicate, and convey trade secrets belonging to Genentech; and c. knowingly and without authorization to receive, buy, and possess trade secrets belonging to Genentech, knowing the same to have been stolen and appropriated, obtained, and converted without authorization. INDICTMENT 1 3 LAN Case Document 1 Filed 10/2558 Page 23 of 28 Manner and Means of the Conspiracy 22. The defendants and others conspired to steal, as prohibited by 18 U.S.C. 1832(a)(1)- (3), trade secrets from Genentech for use by QUACH during his employment at HL. 23. In the summer of 2017, XANTHE LAM referred former Genentech employee QUACH to HL for employment as an engineering manager. A?er QUACH received an employment offer from JHL and was no longer employed by Genentech, XANTHE LAM allowed QUACH to use XANTHE login credentials to access Genentech secure databases of manufacturing, equipment, and facilities policies and procedures on at least three different occasions in July 2017, to ?refresh [him]self? regarding some of the documents. QUACH downloaded documents containing trade secrets from the Genentech password-protected document repository for his work at HL. XANTHE LAM also downloaded documents containing trade secrets from the Genentech password-protected document repository for QUACH at request. Overt Acts 24. In ?irtherance of the conspiracy and to effect its iobjects, in the Northern District of California and elsewhere, the defendants committed, among others, the overt acts alleged in Counts 29 through 32 below. All in violation of Title 18, United States Code, Section 1832(a)(5). COUNTS TWENTY-NINE THROUGH THIRTY-TWO: (18 U.S.C. 2 Theft of Trade Secrets; Aiding and Abetting) 25. The factual allegations contained in Paragraphs 1 through 24 are realleged and incorporated as if fully set forth here. 26. On the dates set forth below, in the Northern District of California and elsewhere, the defendants listed in the separate counts below, together with others known and unknown to the Grand Jury, intending to convert a trade secret, that was related to a product and service used in and intended for use in interstate and foreign commerce, to the economic bene?t of anyone other than the owner of that trade secret, and knowing and intending that the offense would injure the owner of that trade secret, as speci?cally alleged in each of the Counts 29 through 32 below: a. knowingly stole, and without authorization appropriated, took, carried away, INDICTMENT 14 Case Document 1 Filed Page 24 of 28 concealed, and by fraud, arti?ce, and deception obtained trade secrets belonging to Genentech; b. knowingly and without authorization copied, duplicated, sketched, drew, downloaded, uploaded, altered, photocopied, replicated, transmitted, delivered, sent, communicated, and conveyed trade secrets belonging to Genentech; and c. knowingly and without authorization received, bought, and possessed trade secrets belonging to Genentech, knowing the same to have been stolen and appropriated, obtained, and converted without authorization: COUNT DATE DEFENDANTS ACTION TRADE SECRETS 29 July 9, 2017 XANTHE LAM, Downloaded from Manufacturing protocols QUACH to: Maintain Equipment, password-protected Manage Risks, Ensure document repository Product Purity 30 July 16, 2017 XANTHE LAM, Downloaded from Manufacturing protocols QUACH to: Maintain Facilities, password-protected Manage Risks, Ensure document repository Product Purity, for Preventing Contamination 31 July 26, 2017 XANTHE LAM, Downloaded from Manufacturing protocols QUACH to: Maintain Equipment, password-protected Maintain a Sterile document repository Enviromnent, Ensure Product Purity, for Preventing Contamination 32 Aug. 13, 2017 XANTHE LAM, Downloaded from Manufacturing protocols QUACH to: Maintain Facilities password-protected Maintain a Sterile document repository Enviromnent Each in violation of Title 18, United States Code, Sections 2. COUNT (18 U.S.C. 1030(b) Conspiracy to Commit Computer Fraud and Abuse) 27. The factual allegations contained in Paragraphs 1 through 27 are realleged and incorporated as if fully set forth herein. 28. On or about and between July 2017 and August 2017, in the Northern District of California and elsewhere, the defendants XANTHE LAM and JAMES QUACH, INDICTMENT 1 5 . Case Document 1 Filed 10/2548 Page 25 of 28 A together with others known and unknown to the Grand Jury, did knowingly and will?illy conspire and agree together, with each other, and with others known and unknown to the grand jury, to commit computer fraud and abuse, that is, to access protected computers without authorization and to exceed authorized access to protected computers, and to obtain thereby information from protected computers, for the purpose of commercial advantage and private ?nancial gain, in furtherance of a criminal act in violation of the laws of the United States, namely Theft of Trade Secrets in violation of 18 U.S.C. 1832, and where the value of the information did, and would if completed, exceed $5,000. Manner and Means of the Conspiracv 29. It was part of the conspiracy that the defendants, XANTHE LAM and QUACH, and others known and unknown to the grand jury agreed to participate in access Genentech?s computers without authorization and exceeding authorized access, in order to steal trade secrets. 30. The objects of the conspiracy were carried out, in part, as alleged in Paragraphs 22 and 23, above. Overt Acts 31. In furtherance of the conspiracy and to effect its objects, in the Northern District of California and elsewhere, the defendants committed, among others, the overt acts alleged in Counts 34 through 36 below. In violation of Title 18, United States Code, Section 1030(b). COUNTS THIRTY-FOUR THROUGH THIRTY-SIX: (18 U.S.C. 1030(a)(2)(C), (ii) 2 Computer Fraud and Abuse; Aiding and Abetting) 32. The factual allegations contained in Paragraphs 1 through 30 are realleged and incorporated as if fully set forth herein. 33. On or aboutthe dates set forth in the separate counts below, in the Northern District of California and elsewhere, the defendants XANTHE LAM and JAMES QUACH intentionally accessed a computer without authorization and exceeding authorized access, and obtained information from a computer that was used in and affected interstate and foreign commerce and IN DICTMENT 6 Case Document 1 Filed Page 26 of 28 communication, and the offense was to obtain information from protected computers, for the purpose of commercial advantage and private ?nancial gain, in furtherance of a criminal act in violation of the laws of the United States, namely Theft of Trade Secrets in violation of 18 U.S.C. 1832, and where the value of the information did, and would if completed, exceed $5,000, that is, the defendants accessed Genentech?s computer network without authorization in order to steal scienti?c and technical documents. COUNT DATE ACTION DOCUMENTS DOWNLOADED 34 July 9, 2017 XANTHE LAM, Downloaded from Manufacturing protocols to: QUACH Genentech?s Maintain Equipment, Manage password-protected Risks, Ensure Product document repository Purity 35 July 16, 2017 XANTHE LAM, Downloaded from Manufacturing protocols to: QUACH Genentech?s Maintain Facilities, Manage password-protected Risks, Ensure Product Purity, document repository for Preventing Contamination 36 July 26, 2017 XANTHE LAM, Downloaded from Manufacturing protocols to: QUACH Genentech?s Maintain Equipment, Maintain password-protected a Sterile Environment, Ensure document repository Product Purity, for Preventing Contamination Each in violation of Title 18, United States Code, Sections 1030(a)(2)(C), FORFEITURE ALLEGATION: (18 U.S.C. 982, 1030, 1834 and 2323 Proceeds and Property Involved in Computer Fraud and Abuse and Theft of Trade Secrets) 34. The allegations contained in Counts 1 through 37 of this Indictment are hereby realleged and incorporated by reference for the purpose of alleging forfeiture pursuant to 18 U.S.C. 1030(i), and 2323(b). 35. As a result of conviction on one or more of the felony offenses set forth in Counts 1 through 27 of this Indictment, defendants, XANTHE LAM, ALLEN LAM, and JOHN CHAN, shall forfeit the following property, real or personal, to the United States: IN DICTMENT 1 7 Case Document 1 Filed Page 27 of 28 (1) Any article, the making or traf?cking of which, is prohibited under 18 U.S.C. Chapter 90; (2) Any property used, or intended to be used, in any manner or part to commit or facilitate a violation of 18 U.S.C. Chapter 90; and (3) Any property constituting or derived from any proceeds obtained directly or indirectly as a result of a Violation of 18 U.S.C. Chapter 90. 36. As a result of conviction on one or more of the felony offenses set forth in Counts 28 through 32 of this Indictment, defendants: XANTHE LAM and JAMES QUACH, shall forfeit to the United States of America: (1) Any article, the making or traf?cking of which, is prohibited under 18 U.S.C. Chapter 90; (2) Any property used, or intended to be used, in any manner or part to commit or facilitate a violation of 18 U.S.C. Chapter 90; and (3) Any property constituting or derived from any proceeds obtained directly or indirectly as a result of a violation of 18 U.S.C. Chapter 90. 37. As a result of conviction on one or more of the felony offenses set forth in Counts 33 through 36 of this Indictment, defendants: XANTHE LAM and JAMES QUACH, shall forfeit to the United States of America: (1) pursuant to 18 U.S.C. 982(a)(2)(B) and 1030(i), any property, real or personal, constituting, or derived from, proceeds obtained directly or indirectly as a result of such offense; and (2) pursuant to 18 U.S.C. 1030(i), any personal property that was used or intended to be used to commit or to facilitate the commission of such offense. 38. If any of the property described above, as a result of any act or omission of the defendants: a. cannot be located upon the exercise of due diligence; b. has been transferred or sold to, or deposited with, a third party; INDICTMENT 8 Case Document 1 Filed 10/25/i8 Page 28 of 28 c. has been placed beyond thejurisdiction of the court; (1. has been substantially diminished in value; or e. has been commingled with other property which cannot be divided without difficulty, the United States of America shall be entitled to forfeiture of substitute property pursuant to 21 U.S.C. 853(p), as incorporated by 18 U.S.C. 2323(b). All pursuant to 18 U.S.C. 853, 982, 1030, 1834, and 2323 and Fed. R. Crim. P. 32.2. DATED: A TRUE BILL. f, ALEX G. TSE United States Attorney H. 1-1me JOHN H. HEMANN Deputy Chief, Criminal Division (Approved as to form: Parrella/ Kane INDICTMENT 19