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Federal Criminal TrialtranscripttranscriptKingshuk Das — Cross/Redirect/Recross (Continued) - Day 31 - Federal Criminal TrialArgument over unavailable laboratory data preceded Kingshuk Das's cross-examination, redirect, and recross about Edison testing, remediation, communications with CMS, and Holmes's role in the laboratory response.
John C. BosticRobert S. LeachJeff SchenkKevin M. DowneyKatherine TrefzLance A. WadeEdward J. DavilaKingshuk DasJudge DavilaMr. SchenkMr. WadeMs. TrefzCourt ClerkKingshuk DasMr. LeachJurorMr. BosticMr. Downeyproceduralcrossredirectrecross
Federal Criminal Trial/Day 31/November 10, 2021
2 pages·2 witnesses·3,247 lines
Argument over unavailable laboratory data preceded Kingshuk Das's cross-examination, redirect, and recross about Edison testing, remediation, communications with CMS, and Holmes's role in the laboratory response.
Proceedings
ProceduralLIS Evidence and Door-Opening HearingLine 1
CrossKingshuk Das — CrossLine 21
RedirectKingshuk Das — RedirectLine 4
RecrossKingshuk Das — RecrossLine 2
ProceduralProc.LIS Evidence and Door-Opening Hearing

SAN JOSE, CALIFORNIA NOVEMBER 10, 2021 P R O C E E D I N G S

(COURT CONVENED AT 8:32 A.M.)

(JURY OUT AT 8:32 A.M.)

JUDGE DAVILA: WE'RE ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL ARE PRESENT AND MS. HOLMES IS PRESENT. I UNDERSTAND THAT COUNSEL WANTED TO SPEAK ABOUT SOMETHING?

MR. SCHENK: YES. GOOD MORNING. THANK YOU, YOUR HONOR. THERE ARE TWO ISSUES THAT WE WANTED TO BRING TO THE COURT'S ATTENTION. THE FIRST ONE I THINK WE WOULD BENEFIT FROM SOME GUIDANCE FROM THE COURT ON. THE ISSUE IS RELATED TO LIS. THIS ISSUE HAS BEEN RAISED TO THE COURT PREVIOUSLY. IT WAS AROUND THE TIME OF THE CROSS-EXAMINATION OF DR. ROSENDORFF. THE DEFENSE ASKED QUESTIONS ABOUT WHETHER THERANOS HAD AN LIS AND THE CAPABILITIES OF LIS. AT THAT TIME WE RAISED TO THE COURT THE QUESTION OF WHETHER THE DOOR HAD BEEN OPENED TO THE GOVERNMENT PRESENTING THE TRUE STORY ABOUT WHY LIS IS NOT AVAILABLE, AND WE RAISED THAT AT THE TIME FOR THE COURT TO CONSIDER AND SUGGESTED THAT WE MIGHT BE RAISING IT LATER IN THE TRIAL DEPENDING ON HOW QUESTIONS PROCEED. YESTERDAY DURING THE CROSS-EXAMINATION OF DR. SAWYER, THE DEFENSE WENT THROUGH ABOUT SEVEN OR EIGHT PAGES OF THE LIS SOP AND ASKED QUESTIONS, AGAIN, ABOUT THE CAPABILITIES OF LIS, ITS FUNCTIONALITY, OF A WITNESS WHO HASN'T USED IT.

WE NOW WONDER, FROM THE COURT, WHETHER THE DOOR HAS BEEN OPENED TO THE GOVERNMENT CALLING WITNESSES TO ADDRESS THE REASON WHY LIS IS NOT AVAILABLE. I CAN EVEN REFINE THE ISSUE A LITTLE BIT MORE FOR THE COURT. WHAT WE'RE INTERESTED IN IS KNOWING WHETHER THE DEFENSE IS GOING TO BE PERMITTED IN ARGUMENT TO SUGGEST THAT THERE IS MISSING EVIDENCE, THAT THE EVIDENCE IS LACKING AND, THEREFORE, INSUFFICIENT TO SUPPORT CONVICTIONS ON COUNTS FOR WHICH LIS IS RELEVANT. I DISTINGUISH THAT FROM ARGUMENTS THAT THERANOS RAN A GOOD LAB BECAUSE IT HAD LIS, BECAUSE LABS ARE SUPPOSED TO HAVE LIS. THAT'S WHAT THE TESTIMONY FROM DR. SAWYER WAS. THERANOS HAD LIS AND THEREFORE, THERANOS WAS A GOOD LAB. THAT'S LEGITIMATE, AND I DON'T THINK I NEED TO CALL WITNESSES TO ADDRESS THIS SORT OF MISSING EVIDENCE POINT IF THAT'S THE DIRECTION THAT THEY'RE GOING. BUT IF THE DEFENSE IS GOING TO ARGUE THAT THE EVIDENCE IS INSUFFICIENT TO CONVICT ON THE PATIENT COUNTS OR ON THE CONSPIRACY COUNT THAT IS RELATED TO THAT, OUR VIEW IS THAT THE DOOR HAS BEEN OPENED IF THAT'S THE WAY THAT THE EVIDENCE IS GOING TO BE ARGUED, AND WE SHOULD BE ALLOWED TO EXPLAIN WHY THERE ISN'T MISSING EVIDENCE, AND I THINK WE WOULD BENEFIT FROM SOME CLARITY ON THAT ISSUE AS WE PLAN OUT THE REMAINING WITNESSES IN THE CASE.

JUDGE DAVILA: THANK YOU.

MR. SCHENK: THERE'S ONE OTHER ISSUE, BUT I'LL PAUSE.

JUDGE DAVILA: OKAY. THANK YOU, MR. SCHENK. MR. WADE.

MR. WADE: GOOD MORNING. MR. SCHENK RAISES A FAIR ISSUE. WE OBVIOUSLY HEARD THE COMMENTS THAT WERE MADE BY COUNSEL FOR THE GOVERNMENT AT THE TIME OF DR. ROSENDORFF'S EXAMINATION. WE UNDERSTAND THE POINT HE'S MAKING NOW. WE WOULD LIKE TO THINK ABOUT IT, LOOK AT THE TRANSCRIPTS, AND GIVE A MORE INFORMED VIEW. I DON'T THINK THE ISSUE IS WHETHER OR NOT THE LIS IS MISSING. THE LIS IS MISSING. I THINK THE LITIGATION RELATING TO THAT IS, WHO IS RESPONSIBLE FOR THAT? AND IF WE WERE TO COME IN AND BLAME THE GOVERNMENT FOR NOT OBTAINING THAT EVIDENCE OR FAULTING THEM FOR FAILING TO PRESENT ALL OF THAT EVIDENCE OR OBTAINING THAT, WHATEVER THE CASE MAY BE, WE'LL HAVE TO LOOK BACK AT THE COURT'S ORDER, THAT MAY OPEN THE DOOR TO, WELL, WHO IS ACTUALLY RESPONSIBLE FOR THE LIS NOT BEING HERE? THE LIS IS -- NUMEROUS WITNESSES HAVE SAID, AND I EXPECT TO A DEGREE DR. DAS MAY SAY THIS TODAY, IT'S PART OF THE CORE FUNCTION OF THE LAB, IT'S HOW IT TRACKS ITS DATA, IT'S HOW IT TRACKS ITS PATIENTS, AND THEY LOOK AT THIS INFORMATION, AND I THINK ALL OF THAT QUESTIONING IS FAIR AND APPROPRIATE IN THE CASE AND IT'S KIND OF AT THE HEART OF THE LAB ISSUES. I DON'T THINK IT OPENS THE DOOR TO SOME MINI TRIAL ABOUT WHO AT THERANOS WAS RESPONSIBLE FOR, YOU KNOW, NOT PRESERVING LIS AT THE TIME THE COMPANY WAS WRAPPING UP OPERATIONS BECAUSE, AS THE COURT KNOWS, THE GOVERNMENT HAS PRESENTED NO EVIDENCE THAT MS. HOLMES WAS, YOU KNOW, INVOLVED IN THOSE DECISIONS OR RESPONSIBLE FOR THOSE DECISIONS.

JUDGE DAVILA: I THINK THAT'S WHAT MR. SCHENK IS ACTUALLY SAYING. HE'S SAYING WE HAVE IT AND WE DON'T THINK IT'S APPROPRIATE. BUT WHAT I HEAR MR. SCHENK SAYING IS, I'M ASKING DIRECTION FROM THE COURT. IS IT APPROPRIATE NOW BECAUSE HAS THE DOOR BEEN OPENED? IS THE KNOB TURNED AND IS THE DOOR OPENED? AND I DON'T THINK MR. SCHENK PARTS COMPANY WITH YOU TALKING ABOUT OBVIOUSLY LABS HAVE TO HAVE THE LIS. THAT'S PART OF AN INTEGRAL COMPONENT TO THE LEGITIMACY OF THE LAB. SHIFTING THE ISSUE IS -- AND WE HAD LITIGATION ON THIS PRETRIAL, AND I THINK YOU'RE RIGHT TO FOCUS ON IT -- IF THERE'S GOING TO BE -- IF PART OF THIS TRIAL BECOMES RESPONSIBILITY FOR THE LOSS OF THE LIS, AND IF PART OF THE TRIAL BECOMES THAT'S EVIDENCE THAT IS IMPORTANT TO ONE SIDE OR THE OTHER, AND THEN CONNECTED TO THAT IS, IF THERE'S GOING TO BE AN ARGUMENT ABOUT IT DOESN'T EXIST, AND IT DOESN'T EXIST BECAUSE THE GOVERNMENT LOST IT, THEN WE'LL HAVE SOME LITIGATION ON THAT PROBABLY IN FRONT OF THE JURY.

MR. WADE: YEAH, IT WOULD SEEM THAT'S THE CASE, YOUR HONOR. AS THE COURT KNOWS, WE, WE -- WE'RE NOT AFRAID OF THAT LITIGATION IN THE SENSE THAT, YOU KNOW, WE DON'T THINK IT INVOLVES MS. HOLMES.

MR. WADE: AND IT'S JUST A QUESTION OF WHETHER IT WAS THE GOVERNMENT'S RESPONSIBILITY AND THEIR FAILURES, OR WHETHER -- AND SOME OF THE MEMBERS OF THE TEAM PRESENT MAY BE WITNESSES WITH RESPECT TO THAT. BUT I DO THINK IT'S A SIGNIFICANT ISSUE WITH RESPECT TO SORT OF THE PROCEEDING WITHIN THE TRIAL IN THE SENSE THAT THAT COULD ELONGATE THE TRIAL BY, YOU KNOW, A WEEK OR TWO TO LITIGATE THOSE ISSUES. SO I THINK IT'S SOMETHING THAT WE SHOULD, WE SHOULD GIVE SOME THOUGHT TO IN LIGHT OF THE FACT THAT MR. SCHENK IS RAISING IT AS TO HOW WE MIGHT WANT TO ARGUE THE ISSUE, AND THEN GIVE THE GOVERNMENT NOTICE AS TO WHAT WE MIGHT DO. AND IF THEY -- IF THERE'S A -- ANY AMBIGUITY AS TO WHETHER WE'RE OPENING THE DOOR, WE CAN PRESENT IT TO THE COURT. AND IF THE GOVERNMENT -- IF --

JUDGE DAVILA: I THINK THAT'S WHAT MR. SCHENK IS DOING NOW.

MR. WADE: YEAH. YEAH. ALL I'M SAYING IS THAT I'M NOT PREPARED TO TELL THE COURT WHAT WE'RE PREPARED TO ARGUE IN CLOSING ON THIS ISSUE GIVEN THIS ISSUE WAS RAISED THIS MORNING.

JUDGE DAVILA: WELL -- I'M SORRY, I KEEP CUTTING YOU OFF. I APOLOGIZE, MR. WADE. BUT BEFORE WE LOSE THIS WITNESS, IT MAY BECOME NECESSARY TO EXAMINE THIS WITNESS AS TO SOME OF THESE TOPICS. I DON'T KNOW. AND I THINK THAT'S -- THAT'S WHY I'M TAKING THAT IT'S BEING RAISED NOW. IF IT'S APPROPRIATE TO GET INFORMATION ABOUT THE LIS FROM THIS WITNESS, WE DO IT WHILE HE'S HERE, AS OPPOSED TO BRINGING HIM BACK I SUPPOSE, THAT COULD BE IT. BUT, YOU KNOW, I APPRECIATE YOUR OBSERVATION OF NOT WANTING TO ELONGATE THE TRIAL. I THINK THAT'S WHAT I HEARD YOU SAY.

JUDGE DAVILA: THE TRIAL HAS BEEN GOING PRETTY LONG. I DON'T KNOW IF THE GOVERNMENT IS CLOSE TO THE END OF THEIR CASE. IT SOUNDS LIKE -- I'M PARAPHRASING MR. BOSTIC, THEY'RE PROBABLY CLOSER TO THE END THAN THE BEGINNING I WOULD THINK, AND WE CAN WRAP UP VERY SOON I THINK. BUT -- AND I HAVE TO SAY, MY EARS OPENED UP A LITTLE MORE YESTERDAY WHEN I HEARD LIS BEING MENTIONED FOR THIS VERY REASON, BECAUSE IT IS A CONTROVERSIAL TOPIC. WE HAD LITIGATION ON IT PRETRIAL, AND THE ISSUE ABOUT RESPONSIBILITY FOR THAT AND WHETHER OR NOT THAT RESPONSIBILITY GOES BACK TO YOUR CLIENT OR NOT IS STILL PERHAPS AN OPEN ISSUE. I DON'T KNOW. BUT I APPRECIATE YOUR CONCERN ABOUT WANTING TO INFECT THAT ISSUE IN THE TRIAL. MR. SCHENK IS TELLING ME THAT IT'S COMING CLOSE, JUDGE, AND WE JUST WANT TO KNOW. I UNDERSTAND YOU NEEDED TO CONSULT WITH YOUR TEAM ABOUT THAT. BUT I DON'T KNOW WHAT TRIAL STRATEGY IS ON BOTH SIDES, BUT I DON'T WANT THE TRIAL TO GO INTO JANUARY. I DON'T THINK WE NEED TO, BUT THAT DEPENDS ON WHAT YOU'RE GOING TO DO WHEN THE GOVERNMENT RESTS, OF COURSE.

MR. WADE: UNDERSTOOD, YOUR HONOR. WE, TOO, HAVE HEARD WE'RE CLOSER TO THE END THAN THE BEGINNING. I THINK FOR SOME OF US THAT PROBABLY DESCRIBES OUR STATE OF LIFE GENERALLY. BUT, YOU KNOW, WE DON'T KNOW EXACTLY WHEN IT IS THAT THE GOVERNMENT INTENDS TO REST. BUT WITH RESPECT TO THIS ISSUE AND THIS WITNESS, TO MY KNOWLEDGE THIS WITNESS DOESN'T HAVE ANY INFORMATION ABOUT THE, YOU KNOW, THE MOTH BALLING OF THE LIS SERVERS OR ANYTHING TO THAT EFFECT. SO I'M NOT SURE THAT WHO IS RESPONSIBLE FOR THE DESTRUCTION OF LIS IS SOMETHING THAT IS RIPE FOR THIS WITNESS. I WILL JUST BE CANDID WITH THE COURT AND COUNSEL. I BELIEVE THAT ON DIRECT EXAMINATION DR. DAS TALKED ABOUT KIND OF THREE PILLARS THAT HE LOOKED AT IN MAKING SOME OF THE JUDGMENTS THAT HE MADE IN CONNECTION WITH HIS WORK, AND I BELIEVE SOME OF THAT RELATED TO DATA THAT HE OBTAINED FROM THE LIS SYSTEM, AND I INTEND TO ASK HIM ABOUT THE PROCESS THAT HE WENT THROUGH. BUT I DON'T INTEND TO ASK HIM QUESTIONS RELATING TO, AND THE GOVERNMENT FAILED TO PRESENT YOU WITH ANY OF THIS EVIDENCE, OR ANYTHING THAT I THINK IS IN THE SPIRIT OF THE ORDER THAT THE COURT ISSUED ON THAT. I JUST -- AND I'M NOT SURE THAT WE'LL BE IN A PLACE WHERE WE WOULD OPEN THE DOOR ON ARGUMENT, BUT I DON'T WANT TO MAKE THAT DECISION ON THE FLY. I WANT TO CONSULT WITH MY TEAM, AND WE CAN COME BACK TO THAT BEFORE WE RESUME TRIAL IF THE GOVERNMENT WOULD LIKE.

JUDGE DAVILA: MR. SCHENK, ANYTHING FURTHER?

MR. SCHENK: COULD, BY 7:00 P.M. TOMORROW, THE DEFENSE LET US KNOW WHETHER THEY INTEND TO ARGUE THAT THE FAILURE OF LIS EVIDENCE TO BE PRESENTED IN THE CASE BY THE GOVERNMENT IS A BASIS TO FIND MS. HOLMES NOT GUILTY? THAT MS. HOLMES SHOULD NOT BE FOUND GUILTY BECAUSE THE EVIDENCE IS INSUFFICIENT? THAT'S WHAT THE HEART OF MY CONCERN IS. TO ARGUE THAT THERANOS HAD LIS, JUST LIKE THEY HAD A GENERAL SUPERVISOR IN THE LAB AND A TECHNICAL SUPERVISOR, THAT'S FINE. I THINK THAT'S APPROPRIATE ARGUMENT. IT'S APPROPRIATE FOR THEM TO SAY, THERANOS WAS A LEGITIMATE LAB AND LET ME GIVE YOU THE REASONS WHY, ONE OF THOSE IS THAT YOU HEARD THAT THEY HAD AN LIS. THE COURT HAS HEARD AND COUNSEL HAS HEARD ME SAY, I DON'T OBJECT TO THAT.

WHAT DOES PROVIDE SOME CONCERN TO ME IS THE KINDS OF QUESTIONS THAT THEY HAVE ASKED ON CROSS MIGHT BE USED IN ARGUMENT TO SUGGEST THAT YOU HEARD THAT THERANOS HAD AN LIS, YOU HEARD WHAT ITS CAPABILITIES WERE AND THE KIND OF DATA THAT IT STORED, AND THAT EVIDENCE WASN'T PRESENTED TO YOU AND THE GOVERNMENT IS ASKING YOU TO CONVICT MS. HOLMES OF OFFENSES RELATED TO THE PATIENT COUNTS. YOU CAN'T DO THAT WITHOUT KNOWING WHAT WAS IN LIS. THAT'S WHERE THE REAL EVIDENCE IS. THAT WOULD NOT BE APPROPRIATE TO ARGUE WITHOUT A FINDING BY THE COURT THAT THE DOOR HAS BEEN OPENED SO THE GOVERNMENT'S CASE-IN-CHIEF CAN ARGUE ABOUT WHERE LIS IS AND WHY IT IS NOT IN FRONT OF THE COURT. THAT'S THE HEART OF MY CONCERN. AND AS THE COURT NOTED, AS WE PLAN OUT OUR REMAINING WITNESSES IN THE CASE, IT WOULD BE VERY HELPFUL TO KNOW IF THE DOOR HAS BEEN OPENED AND WE CAN PRESENT THE LIS DESTRUCTION EVIDENCE, OR WHETHER THE DEFENSE JUST INTENDS TO ARGUE LIS WAS ONE OF MANY THINGS THAT SHOWED THERANOS HAD A GOOD LAB OR WAS TRYING TO HAVE A GOOD LAB. THAT'S SORT OF THE FORK IN THE ROAD AS I SEE IT, AND IT WOULD BE HELPFUL TO KNOW TOMORROW EVENING AS WE PRESENT OUR NEXT ROUND OF NAMES TO THE DEFENSE ON A THURSDAY 7:00 P.M. DEADLINE OF WHO WOULD TESTIFY.

MR. WADE: THE COURT'S INDULGENCE FOR ONE SECOND?

JUDGE DAVILA: NO, NO. SURE. OF COURSE.

(DISCUSSION AMONGST DEFENSE COUNSEL OFF THE RECORD.)

MR. WADE: TWO ISSUES, YOUR HONOR. FIRST OF ALL, WITH RESPECT TO MR. SCHENK'S REQUEST, WE CAN DO SLIGHTLY BETTER, WHICH IS WE CAN INFORM THE GOVERNMENT BY 4:00 P.M. TOMORROW WHETHER WE CAN RULE OUT THE POSSIBILITY THAT WE CAN OFFER THAT DEFENSE. I WON'T BE IN A POSITION TO TELL THE GOVERNMENT WE ARE OR ARE NOT GOING TO OFFER IT UNTIL MUCH LATER, AS THE COURT KNOWS. BUT WE CAN ADVISE THE GOVERNMENT AS TO WHETHER WE'LL RULE THAT OUT. WE SUGGEST 4:00 P.M. BECAUSE THE GOVERNMENT GIVES US NOTICES OF WITNESSES AT 7:00 P.M., AND SO WE'LL GIVE THEM A FEW HOURS TO CONSIDER OUR POSITION ON THAT. I DO WANT TO MAKE ONE POINT CLEAR, THOUGH, WHICH IS WE'RE MOVING THE GOALPOST A LITTLE BIT HERE, WHICH IS WE HAVE NOT YET OPENED THE DOOR ON THIS ISSUE AND THE GOVERNMENT IS NOW ASKING FOR A DIFFERENT INQUIRY. SO I DON'T THINK WE'VE OPENED THE DOOR TO MAKING THIS ARGUMENT AND PRESENTING THIS EVIDENCE. IF WE GO INTO THESE ISSUES IN OUR CASE AND THE GOVERNMENT WANTS TO PRESENT THESE ISSUES IN REBUTTAL, YOU KNOW, THAT'S A DIFFERENT STORY. BUT I THINK THROUGH THE QUESTIONING WE HAVEN'T ELICITED THE TYPES OF QUESTIONS THAT, UNDER THE COURT'S ORDER ON THIS ISSUE, WOULD OPEN THE DOOR. SO I THINK THAT'S WHAT WAS CONTEMPLATED. I DON'T THINK IT WAS CONTEMPLATED THAT IN THE MIDDLE OF THE GOVERNMENT'S CASE THAT WE WERE TO BE TOLD, WE WERE TO BE ASKED TO CONFINE AND DEFINE ALL OF THE -- OUR DEFENSES AND WHAT WE INTEND TO PRESENT IN OUR CASE AND WHAT WE INTEND TO ARGUE TO THE JURY, BECAUSE I DON'T THINK, YOU KNOW, THAT'S OBVIOUSLY CONSTITUTIONALLY APPROPRIATE TO EVER REQUIRE DEFENSE COUNSEL TO DO THAT. THAT BEING SAID, WE'LL BE IN A POSITION TO PROVIDE THAT, THE NOTICE REQUESTED BY THE GOVERNMENT.

JUDGE DAVILA: THANK YOU. AND THERE IS SOME TENSION HERE, TENSION IN THAT THE DEFENSE SHOULD NOT HAVE BURDEN SHIFTING, OR THE DEFENSE SHOULD NOT HAVE TO REVEAL ANY OF THEIR DEFENSES IN THE PROSECUTION CASE, OF COURSE. THE TENSION, HOWEVER, JUXTAPOSED WITH THAT IS, OF COURSE, THE PRETRIAL ISSUE AND THIS ISSUE DOES LINGER IN THIS CASE ABOUT THE LIS AND WHETHER OR NOT RESPONSIBILITY ABOUT -- AS TO ITS DESTRUCTION IS GOING TO BE AN ISSUE IN THE CASE. AND WE'VE TALKED LONG AND HARD ABOUT DOORS AND OPENING THEM, AND I THINK THAT'S RIPE FOR DISCUSSION HERE AND I THINK IT'S APPROPRIATE FOR MR. SCHENK TO RAISE IT JUST AS A CONCERN OF HIS TEAM, AND ALSO IT PERHAPS HAS PROPHYLACTIC ASSISTANCE TO YOU AND YOUR TEAM AS TO GETTING CLOSE AND THERE'S SOME NOTICE HERE AND THIS COULD BE ANOTHER ISSUE. SO I THINK IT'S APPROPRIATE FOR THE DISCUSSION. I DO THINK THAT THE TENSION HERE IS -- AND I DON'T SEE THE GOVERNMENT ASKING YOU TO REVEAL YOUR DEFENSE. THAT'S NOT -- I DON'T TAKE IT THAT WAY, AND IF YOU FEEL THAT WAY, WE SHOULD TALK ABOUT THAT. BUT WHAT I HEAR THE DEFENSE SAYING IS THAT THIS IS AN ISSUE, AND IF IT'S GOING TO BE SOMETHING THAT THE DEFENSE IS PLANNING ON ARGUING BECAUSE THEY HAVE THESE WITNESSES, THEY'RE ASKING THE QUESTION, THEY'RE IN CONTROL OF THAT NOW, AND THEN WE WOULD LIKE -- "WE" THE GOVERNMENT -- WOULD LIKE TO KNOW THAT BECAUSE WE'LL CALL WITNESSES IN OUR CASE-IN-CHIEF APPROPRIATELY. IF YOU FEEL, IF YOU FEEL THAT IT'S GOING INTO YOUR CLIENT'S CONSTITUTIONAL RIGHT TO PUT ON A DEFENSE AND KEEP THAT QUIET UNTIL ITS YOUR TURN, YOU SHOULD TELL ME THAT, TOO, AND WE'LL TALK ABOUT THAT. BUT I THINK THIS IS A LITTLE MORE STRATEGIC THAN THAT, AND NOT IN A PEJORATIVE WAY.

MR. WADE: NO, NO. FAIR POINT, YOUR HONOR. AGAIN, WE WELCOME THE DIALOGUE. IT WAS RAISED THIS MORNING. WE'LL GIVE IT SOME THOUGHT AND WE'LL CONSIDER IT. OF COURSE IT'S PART OF THE REASON WHY OUR SYSTEM ALLOWS THE GOVERNMENT A REBUTTAL CASE, WHICH IS SOMETHING THAT THE DEFENSE DOES NOT HAVE. SO, YOU KNOW, TO THE EXTENT THAT THAT BECOMES AN ISSUE, THEY DO HAVE THAT OPPORTUNITY IN REBUTTAL. BUT WE UNDERSTAND THE COMMENTS OF THE COURT. WE RESPECT MR. SCHENK'S INQUIRY AND THE NOTICE, AND WE'LL BE IN A POSITION TO ADVISE THEM THAT BY 4:00 O'CLOCK TOMORROW.

JUDGE DAVILA: OKAY. GOOD. MR. SCHENK?

MR. SCHENK: NOTHING FURTHER ON THAT ISSUE. THE OTHER VERY BRIEF ISSUE IS THAT THE FIRST WITNESS IN TRIAL WAS DANISE YAM. THE GOVERNMENT HAS ONE EMAIL THAT IT WANTS TO ADMIT. WE ASKED THE DEFENSE IF THEY WOULD STIPULATE TO THE ADMISSION. OBVIOUSLY IT'S THEIR PREROGATIVE TO GIVE US A YES OR NO, THEY ARE NOT INTERESTED IN STIPULATING. AND SO WE WILL BE RECALLING MS. YAM TO ADMIT THIS EMAIL, AND I JUST WANTED TO GIVE THE COURT NOTICE OF IT.

JUDGE DAVILA: OKAY. MS. TREFZ, GOOD MORNING.

MS. TREFZ: THE DEFENSE IS FINE WITH MS. YAM BEING RECALLED FOR THIS LIMITED PURPOSE. IT'S TRUE THAT WE WOULD NOT STIPULATE TO THE ADMISSION OF THIS EMAIL.

JUDGE DAVILA: OKAY. THAT'S FINE. DO YOU HAVE ANY IDEA WHEN THAT IS GOING TO BE?

MR. SCHENK: NEXT WEEK.

JUDGE DAVILA: OKAY. I SEE. SO THAT SHOULD BE A BRIEF -- THE BINDER WILL BE THIN ON THIS --

MS. TREFZ: THERE'S NO GUARANTEE.

JUDGE DAVILA: FAIR ENOUGH. THANK YOU.

MR. SCHENK: THANK YOU.

JUDGE DAVILA: AND I'M JUST HAPPY TO TELL YOU THAT OUR I.T. PEOPLE WORKED HERE, I THINK I GOT AN EMAIL PAST 7:30 THAT THEY HAD WORKED OUT THE BUGS IN THE SYSTEM. SO KNOCKING ON WOOD, I HOPE FOR A PRODUCTIVE DAY TODAY. OKAY. THANK YOU.

MR. WADE: WE'RE VERY APPRECIATIVE. THANK YOU, YOUR HONOR.

COURT CLERK: COURT IS IN RECESS.

(RECESS FROM 8:50 A.M. UNTIL 9:03 A.M.)

(JURY IN AT 9:03 A.M.)

JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. GOOD MORNING. WE ARE BACK ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL ARE PRESENT, MS. HOLMES IS PRESENT. OUR JURY IS PRESENT. LET'S -- IS OUR WITNESS HERE, DR. DAS? YES. MR. WADE, YOU HAVE ADDITIONAL QUESTIONS I THINK?

MR. WADE: I DO, YOUR HONOR. BUT DO YOU WANT TO MAKE YOUR MORNING INQUIRY?

JUDGE DAVILA: I DO, YES, I DO. GOOD MORNING, DR. DAS.

KINGSHUK DAS: GOOD MORNING.

JUDGE DAVILA: GOOD MORNING, SIR. I'LL ASK YOU TO STATE YOUR NAME AGAIN. YOU CAN TAKE YOUR MASK OFF IF YOU WOULD LIKE.

KINGSHUK DAS: THANK YOU, YOUR HONOR. KINGSHUK DAS.

JUDGE DAVILA: THANK YOU. I'LL REMIND YOU YOU'RE STILL UNDER OATH, SIR.

(GOVERNMENT'S WITNESS, KINGSHUK DAS, WAS PREVIOUSLY SWORN.)

JUDGE DAVILA: AND MR. WADE, BEFORE YOU BEGIN, LADIES AND GENTLEMEN, GOOD MORNING. I JUST WANT TO ASK YOU THAT QUESTION. OVERNIGHT, SINCE YOU LEFT HERE, DID ANY OF YOU HAVE OCCASION TO COME ACROSS, DISCUSS, READ, WATCH OR SEE ANYTHING TO DO ABOUT THIS CASE IN ANY OTHER MANNER? IF SO, PLEASE RAISE YOUR HAND. I SEE NO HANDS. THANK YOU VERY MUCH. MR. WADE.

MR. WADE: THANK YOU, YOUR HONOR.

CROSS-EXAMINATION (RESUMED) BY MR. WADE:

MR. WADE: GOOD MORNING, DR. DAS.

KINGSHUK DAS: GOOD MORNING.

MR. WADE: I HAVE SOME QUESTIONS FOR YOU THIS MORNING. I WOULD LIKE TO START WHERE YOU STARTED, WHICH WAS WHEN YOU WERE JOINING THE COMPANY IN DECEMBER OF 2015. I'D LIKE TO ASK YOU SOME QUESTIONS ABOUT YOUR QUALIFICATIONS FOLLOWING UP ON SOME OF THE QUESTIONS THAT THE GOVERNMENT ASKED. OKAY?

MR. WADE: COULD I TURN YOUR ATTENTION -- ACTUALLY, YOUR HONOR, MAY I APPROACH?

BY MR. WADE:

MR. WADE: (HANDING.)

KINGSHUK DAS: THANK YOU.

MR. WADE: DR. DAS, I'VE HANDED YOU A BINDER OF DOCUMENTS THAT I MAY REFER TO DURING THE EXAMINATION. YOU'LL NOTICE THAT THE EXHIBITS ARE NUMBERED ON THE SIDE, AND SO I'LL CALL ATTENTION TO THEM AS WE'RE ASKING QUESTIONS. OKAY?

MR. WADE: THE FIRST EXHIBIT I'D LIKE TO DRAW YOUR ATTENTION TO IS EXHIBIT 10290.

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE YOUR RESUME AS OF 2015 AT THE TIME THAT YOU WERE APPLYING FOR THE POSITION AT THERANOS?

MR. WADE: AND DO YOU UNDERSTAND ONE OF THE RESPONSIBILITIES UNDER CLIA IS FOR A LABORATORY TO LOG INFORMATION RELATING TO THE QUALIFICATIONS OF THEIR PERSONNEL? YOU'RE AWARE OF THAT?

MR. WADE: AND TO DOCUMENT THAT?

MR. WADE: AND THAT'S FREQUENTLY DONE BY PUTTING A COPY OF THE RESUME AND OTHER CERTIFICATIONS AND THE LIKE IN THE FILES; IS THAT RIGHT?

MR. WADE: I MOVE THE ADMISSION OF 10290.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10290 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: THE GOVERNMENT YESTERDAY ASKED YOU SOME QUESTIONS ABOUT YOUR TRAINING AND BACKGROUND, AND I'D JUST LIKE TO ASK A FEW MORE BASED ON THE RESUME. LET ME START WITH THE QUESTION THE GOVERNMENT ASKED. YOU MENTIONED YOU WERE BOARD CERTIFIED. DO YOU RECALL THAT?

MR. WADE: AND I THINK YOU SAID YOU WERE BOARD CERTIFIED IN CLINICAL PATHOLOGY.

MR. WADE: AND WHAT DOES BOARD CERTIFICATION MEAN?

KINGSHUK DAS: IT MEANS YOU'VE MET THE REQUIREMENTS TO TAKE A CERTAIN EXAMINATION, IN THIS CASE CLINICAL PATHOLOGY, SUPPLIED BY THE AMERICAN BOARD OF PATHOLOGY. SO YOU HAVE TO MEET THEIR TRAINING REQUIREMENTS FOR THE EXAMINATION, AND THEN YOU HAVE TO PASS THE EXAMINATION, AND THEREAFTER YOU HAVE CERTAIN REQUIREMENTS EVERY TWO YEARS THAT YOU NEED TO MAKE IN ORDER TO MAINTAIN YOUR CERTIFICATION.

MR. WADE: ONGOING TRAINING REQUIREMENTS AND THE LIKE?

MR. WADE: AND SO IF YOU MEET THE REQUIREMENTS TO BE ABLE TO SIT FOR THE EXAMINATION, AND THEN YOU PASS THE EXAMINATION, IS THAT -- IS IT FAIR TO SAY THAT THE CERTIFICATION IS MEANT TO SUGGEST A PARTICULAR EXPERTISE IN AN AREA?

MR. WADE: OKAY. AND YOUR PARTICULAR EXPERTISE WAS IN CLINICAL PATHOLOGY?

MR. WADE: WHICH RELATES FUNDAMENTALLY TO THE OPERATION OF A CLINICAL LABORATORY; CORRECT?

MR. WADE: OKAY. AND YOU TESTIFIED -- IF I CAN DRAW YOUR ATTENTION TO THE TOP UNDER EDUCATION, YOU TESTIFIED YESTERDAY AS TO NUMEROUS RESIDENCIES AND FELLOWSHIPS THAT YOU DID IN YOUR TRAINING; IS THAT CORRECT?

MR. WADE: AND YOU -- I BELIEVE MR. LEACH MENTIONED YOU SPENT TIME BOTH AS A TROJAN AND A BRUIN. DO YOU RECALL THAT?

MR. WADE: AND IN ADDITION TO THAT, YOU HAD -- YOU DID SOME FELLOWSHIPS WITH THE CLEVELAND CLINIC AS WELL?

KINGSHUK DAS: THAT WAS PRIOR TO RESIDENCY, YES.

MR. WADE: THAT WAS PRIOR TO YOUR RESIDENCY. AND THOSE FELLOWSHIPS FOCUSSED -- IN PARTICULAR, ONE OF THEM FOCUSSED ON MOLECULAR PATHOLOGY; IS THAT RIGHT?

MR. WADE: AND YOU HAD A PARTICULAR AREA OF FOCUS WITH RESPECT TO MOLECULAR PATHOLOGY; IS THAT CORRECT?

MR. WADE: AND A PARTICULAR AREA OF EXPERTISE -- THAT WAS A PARTICULAR AREA OF EXPERTISE FOR YOU. IS THAT FAIR?

MR. WADE: OKAY. AND LET'S GO TO UNDER THE CURRENT PROFESSIONAL EXPERIENCE. YOU TALKED A LITTLE BIT, I THINK SOMEWHAT HUMBLY, ABOUT THE FACT THAT YOU WERE A PROFESSOR AT UCLA AS WELL. DO YOU RECALL THAT?

MR. WADE: IN FACT, YOU WERE A SUCCESSFUL PROFESSOR. YOU HAD WON A NUMBER OF AWARDS AND THE LIKE WHILE YOU WERE THERE; CORRECT?

MR. WADE: AND IN ADDITION TO THE WORK THAT YOU WERE DOING THERE AS TEACHING, YOU WERE ALSO WORKING IN THE CLINICAL LABORATORIES AT UCLA; RIGHT?

MR. WADE: AND IS IT FAIR TO SAY THAT UCLA IS A PREMIER INSTITUTION ON THE WEST COAST?

MR. WADE: I -- IN ADDITION TO THAT WORK THAT YOU DID AT UCLA, YOU ALSO SERVED AS A CLINICAL CONSULTANT FOR A NUMBER OF TECHNOLOGY COMPANIES; IS THAT RIGHT?

MR. WADE: AND YOU ACTUALLY HAD A PARTICULAR FOCUS IN LABORATORY MEDICINE AND HOW IT RELATED TO TECHNOLOGY; RIGHT?

MR. WADE: AND IF WE CAN GO AND JUST LOOK AT THE BOTTOM OF YOUR RESUME, WHICH WE'RE DISPLAYING ON THE SCREEN, THIS IDENTIFIES A NUMBER OF DIFFERENT ENTITIES FOR WHOM YOU WERE SERVING IN AN ADVISORY CAPACITY WITH RESPECT TO CERTAIN NOVEL TECHNOLOGIES; IS THAT RIGHT?

KINGSHUK DAS: TO SOME EXTENT, YES.

MR. WADE: AND IF WE JUST CONTINUE UP, IT CAN BE INCLUSIVE OF THE OTHER EXPERIENCES THAT YOU HAD THERE, AND JUST PUT THEM UP TOGETHER, THERE ARE ACTUALLY A NUMBER OF DIFFERENT TECHNOLOGY COMPANIES THAT YOU WERE PROVIDING CONSULTING WORK FOR WITH RESPECT TO LABORATORY MEDICINE AND TECHNOLOGY ISSUES; CORRECT?

MR. WADE: OKAY. AND IS IT FAIR TO SAY THIS BECAME AN AREA OF GREAT INTEREST FOR YOU?

KINGSHUK DAS: I BELIEVE SO, YES.

MR. WADE: AND WAS, WAS THE INTERSECTION OF LABORATORY MEDICINE AND TECHNOLOGY ULTIMATELY ONE OF THE REASONS THAT YOU BECAME ATTRACTED TO WORKING AT THERANOS?

MR. WADE: OKAY. THE -- AND I WON'T GO THROUGH THEM LINE BY LINE, BUT IN ADDITION TO ALL OF THIS OTHER WORK THAT YOU DO, YOU SEEM TO FIND TIME TO WRITE A NUMBER OF RESEARCH PAPERS THAT WERE PEER REVIEWED; IS THAT RIGHT?

MR. WADE: AND WRITING PEER REVIEWED RESEARCH PAPERS IN ACADEMIC WORLDS IS SOMETHING THAT CONNOTES A LEVEL OF PRESTIGE. IS THAT FAIR TO SAY?

MR. WADE: AND I BELIEVE AS OF THIS DATE YOU HAD PUBLISHED, WAS IT MAYBE APPROXIMATELY 15 RESEARCH PAPERS THAT WERE PEER REVIEWED?

MR. WADE: AND WOULD YOU, AT THE TIME YOU WERE APPLYING TO THERANOS, CONSIDERED YOURSELF TO BE A PRETTY THOROUGH SCIENTIST?

KINGSHUK DAS: IF YOU COULD PLEASE CLARIFY.

MR. WADE: SURE. WHEN YOU RESEARCHED ISSUES AND CAME TO CONCLUSIONS, DID YOU LIKE TO DO THOROUGH AND COMPREHENSIVE RESEARCH BEFORE YOU CAME TO A CONCLUSION?

MR. WADE: AND WERE YOU INCLINED TO DIG IN DEEPLY ON WHATEVER ISSUE YOU WERE CONSIDERING AND UNDERSTAND THE RELEVANT FACTS BEFORE YOU REACHED CONCLUSIONS?

MR. WADE: AND WAS THAT THE GENERAL APPROACH WITH RESPECT TO SCIENCE THAT YOU BROUGHT TO THERANOS?

MR. WADE: OKAY. AND IF WE CAN GO -- DO YOU RECALL YESTERDAY WE TALKED ABOUT HOW DR. HELFEND HAD COME ON BEFORE YOU JOINED THE COMPANY TO SERVE ON AN INTERIM BASIS AS THE LAB DIRECTOR. DO YOU RECALL THAT?

MR. WADE: AND COULD WE TAKE A LOOK AT 10563 --

MR. WADE: -- WHICH I DON'T BELIEVE IS IN YOUR BINDER?

KINGSHUK DAS: I DON'T SEE IT HERE.

MR. WADE: BUT I WILL PASS THAT ONE UP, DOCTOR. MAY I APPROACH, YOUR HONOR?

BY MR. WADE:

MR. WADE: (HANDING.)

KINGSHUK DAS: THANK YOU.

MR. WADE: AND DO YOU RECOGNIZE 10563 AS A CALIFORNIA DEPARTMENT OF PUBLIC HEALTH FORM THAT PROVIDES NOTIFICATION OF A LAB CHANGE?

MR. WADE: AND YOU KNOW, BASED UPON YOUR WORK IN LABORATORIES, THAT THIS IS THE TYPE OF PAPERWORK THAT IS FILED WITH LABORATORY AUTHORITIES AT THE TIME THAT, FOR EXAMPLE, A LAB DIRECTOR IS ADDED TO WORK AT A COMPANY; IS THAT RIGHT?

MR. WADE: AND THIS PARTICULAR, THIS PARTICULAR NOTIFICATION OF LABORATORY CHANGE RELATES TO THE ADDITION OF DR. HELFEND AS A LAB DIRECTOR; CORRECT?

MR. WADE: MOVE THE ADMISSION OF 10563.

MR. LEACH: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10563 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND I'LL JUST DRAW YOUR ATTENTION TO THE BOTTOM HALF OF THE PAGE. THIS NOTES THAT DR. HELFEND -- WHO I GUESS IS AN M.D. AND A PH.D.; RIGHT?

MR. WADE: AND SHE WAS BEING ADDED AS THE CO-DIRECTOR OF THE LAB. DO YOU SEE THAT?

MR. WADE: BUT NOT AS THE CLIA DIRECTOR AT THIS TIME. SHE WAS JUST ADDED AS A SECONDARY LAB DIRECTOR TO WORK ALONGSIDE THE CLIA LAB DIRECTOR. DO YOU RECALL THAT?

MR. WADE: AND AROUND THIS TIME IN MID-DECEMBER, YOU STARTED ON A PART-TIME BASIS AND YOU WERE ADDED AS THE CLIA LAB DIRECTOR FOR THERANOS; CORRECT?

MR. WADE: AND ALTHOUGH YOU CAN ONLY SERVED ON A PART-TIME BASIS INITIALLY, AS YOU WRAPPED UP YOUR WORK AT UCLA, YOU KNEW THAT DR. HELFEND AND A TEAM OF OTHER PEOPLE WERE INVOLVED IN DIGGING INTO ISSUES AT THERANOS; CORRECT?

MR. WADE: AND THAT GAVE YOU COMFORT THAT EVERYTHING WAS BEING ADDRESSED ADEQUATELY; CORRECT?

MR. WADE: AND I THINK YOU TESTIFIED A LITTLE BIT YESTERDAY ABOUT THE FACT THAT YOU WERE INTERVIEWED FOR YOUR POSITION AT THERANOS BY MS. HOLMES. DO YOU RECALL THAT?

MR. WADE: AND THAT WAS 2015, EARLY DECEMBER?

MR. WADE: AND LET'S TAKE A LOOK AT 10634, WHICH SHOULD BE IN YOUR BINDER.

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE CORRESPONDENCE WITH MS. HOLMES FOLLOWING UP ON THE INTERVIEW THAT YOU HAD WITH HER IN EARLY DECEMBER?

MR. WADE: MOVE THE ADMISSION OF 10634.

MR. LEACH: YOUR HONOR, NO OBJECTION TO THE BOTTOM PORTION OF 10634. THE RESPONSE IS HEARSAY.

(PAUSE IN PROCEEDINGS.)

JUDGE DAVILA: MR. WADE?

MR. WADE: I THINK THE RESPONSE IS RELEVANT TO THIS WITNESS'S UNDERSTANDING OF THE ENGAGEMENT AND CONDITIONS UNDER WHICH HE WAS JOINING THE COMPANY. HE REPORTED DIRECTLY TO MS. HOLMES, AND THIS WAS AN INTERACTION THAT RELATED TO THAT. I'M NOT OFFERING THAT TOP PART FOR THE TRUTH OF THE MATTER ASSERTED WITHIN THE DOCUMENT.

JUDGE DAVILA: WHAT IS THE RELEVANCE?

MR. WADE: I'M SORRY?

JUDGE DAVILA: WHAT IS THE RELEVANCE?

MR. WADE: THE RELEVANCE IS THE CIRCUMSTANCES UNDER WHICH HE WAS BEING ASKED TO JOIN THE COMPANY WITH THE SUPPORT OF --

JUDGE DAVILA: ALL RIGHT. I'LL ADMIT THIS, 10634. THE TOP HALF, LADIES AND GENTLEMEN, YOU'LL SEE DISPLAYED IN JUST A MOMENT. IT'S THE RESPONSE SENT SUNDAY, JANUARY 3RD, 2016 AT 5:18 P.M., THAT IS NOT OFFERED FOR THE TRUTH OF THE MATTER ASSERTED. IT'S NOT OFFERED FOR THE TRUTH OF THE STATEMENTS ASSERTED THERE, BUT ONLY TO SHOW CONTEXT TO THE ORIGINAL EMAIL. ALL RIGHT. IT'S ADMITTED WITH THOSE RESTRICTIONS. IT CAN BE DISPLAYED.

MR. WADE: THANK YOU, YOUR HONOR.

(DEFENDANT'S EXHIBIT 10634 WAS RECEIVED IN EVIDENCE.)

MR. WADE: IF WE CAN FOCUS ON THE FIRST PARAGRAPH IN THE BOTTOM EMAIL.

MR. WADE: AND DO YOU SEE THIS WAS SENT DECEMBER 7TH, 2015? AND YOU THANKED HER FOR THE OPPORTUNITY TO MEET WITH HER OVER THE WEEKEND. DO YOU SEE THAT?

MR. WADE: AND THAT WAS, IN PART, FOR LOGISTICAL REASONS THAT YOU ALL HAD TO HAVE YOUR INTERVIEW OVER THE WEEKEND; CORRECT?

MR. WADE: AND DID YOU GO UP TO PALO ALTO FOR THAT MEETING?

MR. WADE: OKAY. AND YOU NOTE IN THAT LINE THAT "I WAS SO IMPRESSED BY THE VISION OF WHAT YOU'VE ACCOMPLISHED ALREADY, AND YOUR PLANS FOR THE FUTURE." DO YOU SEE THAT?

MR. WADE: AND CAN YOU TELL US A LITTLE BIT WHAT YOU MEANT BY THAT?

KINGSHUK DAS: THAT WAS BASED ON A DISCUSSION THAT WE HAD DURING THE INTERVIEW.

MR. WADE: AND WHAT ASPECTS -- IN THAT INTERVIEW, SHE WAS COMMUNICATING TO YOU WHAT SHE WANTED TO DO WITH THE COMPANY; IS THAT RIGHT?

KINGSHUK DAS: YES. I DON'T RECALL THE SPECIFICS, BUT YES.

MR. WADE: YOU DON'T RECALL THE SPECIFICS?

MR. WADE: AND DO YOU RECALL ANYTHING ABOUT THAT DISCUSSION?

MR. WADE: AND WHAT DO YOU RECALL?

KINGSHUK DAS: I REMEMBER IT BEING A VERY POSITIVE MEETING. I REMEMBER IT BEING VERY CHARISMATIC. IT WAS A VERY POSITIVE MEETING.

MR. WADE: AND AS A RESULT OF THIS, YOU WERE, YOU WERE EXCITED ABOUT THE POSSIBILITY OF GOING AND JOINING THIS ENDEAVOR; IS THAT RIGHT?

MR. WADE: AND IF YOU LOOK DOWN A COUPLE OF PARAGRAPHS TO THE FIRST SENTENCE IN THE LAST PARAGRAPH, YOU ACTUALLY PRETTY QUICKLY ACCEPTED THE POSITION AT THERANOS; CORRECT?

MR. WADE: AND YOU AGREED DURING THIS PERIOD TO START ON THE PART-TIME BASIS ALMOST RIGHT AWAY WHILE YOU WERE WRAPPING UP YOUR WORK AT UCLA; CORRECT?

MR. WADE: YOU WANTED TO BE RESPONSIBLE TO YOUR FORMER LAB AT UCLA AND MAKE SURE EVERYTHING WAS COMPLETED THERE; CORRECT?

MR. WADE: OKAY. AND IF WE CAN GO NEXT -- AND YOU TALKED A LITTLE BIT ABOUT THAT CONTRACTING WORK DURING THAT TRANSITION PERIOD AND HOW YOU SPENT -- YOU TRIED TO SPEND AT LEAST ONE DAY A WEEK UP, UP AT THE FACILITY. IS THAT RIGHT?

MR. WADE: AND YOU WERE OTHERWISE CONSULTING WITH THE COMPANY ON KIND OF AN AS-NEEDED BASIS?

MR. WADE: OKAY. LET'S JUST TAKE A QUICK LOOK AT 14159.

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE AN INVOICE THAT SETS FORTH THE CONSULTING SERVICES THAT YOU PROVIDED IN THAT PERIOD BEFORE YOU BECAME THE FULL-TIME LAB DIRECTOR AT THERANOS?

MR. WADE: I MOVE THE ADMISSION OF 14159.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 14159 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND I WON'T SPEND MUCH TIME ON THIS, BUT THIS JUST SETS FORTH IN THAT TIME PERIOD EACH AND EVERY WEEK YOU TRIED TO GET UP TO THE COMPANY TO DO ON-SITE CONSULTATION WORK FOR A FULL DAY?

MR. WADE: AND YOU WOULD FLY UP FROM L.A. AND SPEND THE DAY AND THEN GO BACK?

MR. WADE: AND THEN THERE'S ALSO ON THE BOTTOM, YOU SEE THERE ARE A NUMBER OF REFERENCES TO PART-TIME REMOTE CONSULTATION. DO YOU SEE THAT?

MR. WADE: AND THAT WAS -- THAT WORK WAS IN ADDITION TO THE WORK THAT YOU WERE DOING WHERE YOU WOULD GO UP ONE DAY A WEEK; RIGHT?

MR. WADE: SO THERE WOULD BE TIMES WHERE YOU WOULD BE PULLED IN TO ASK QUESTIONS OR CONSULT OR PROVIDE GUIDANCE WHILE YOU WERE WORKING REMOTELY; IS THAT RIGHT?

MR. WADE: OKAY. AND DO YOU RECALL THAT IN THIS TIME PERIOD, THE GOVERNMENT -- OR THE COMPANY WAS ALSO IN THE PROCESS OF CREATING A SCIENTIFIC ADVISORY BOARD?

KINGSHUK DAS: I DON'T RECALL THAT.

MR. WADE: OKAY. LET ME SEE IF I CAN REFRESH YOUR RECOLLECTION. LET'S LOOK AT 10665.

KINGSHUK DAS: APOLOGIES, MR. WADE. JUST A MOMENT.

MR. WADE: NO APOLOGIES, DOCTOR. TAKE WHATEVER TIME YOU NEED.

KINGSHUK DAS: COULD YOU REPEAT THAT NUMBER, PLEASE.

MR. WADE: SURE. IT'S 10665.

KINGSHUK DAS: 10665. OKAY. THERE WE GO.

MR. WADE: FEEL FREE TO TAKE THE TIME YOU NEED. AND I'M JUST GOING TO ASK A FEW QUESTIONS ABOUT THE DOCUMENT, BUT IF YOU JUST WANT TO TAKE A FEW SECONDS AND FAMILIARIZE YOURSELF YOUR WITH THE CONTENT GENERALLY.

(PAUSE IN PROCEEDINGS.)

KINGSHUK DAS: YES. OKAY.

BY MR. WADE:

MR. WADE: OKAY. DOES THIS REFRESH YOUR RECOLLECTION THAT IN THIS TIME PERIOD, THE COMPANY WAS CREATING A SCIENTIFIC REVIEW COMMITTEE TO HELP ADVISE THE COMPANY?

MR. WADE: AND DO YOU RECALL THAT YOUR INPUT ON MEMBERSHIP RELATING TO THAT COMMITTEE WAS SOLICITED?

MR. WADE: I WOULD MOVE THE ADMISSION OF 10665.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10665 WAS RECEIVED IN EVIDENCE.)

MR. WADE: IF WE CAN GO TO THE SECOND PAGE AND BLOW UP THAT TOP -- YEAH, THE MIDDLE DOWN THROUGH NUMBER 1. THANK YOU, MR. BENNETT.

MR. WADE: AND THIS WAS AN EMAIL FROM DANIEL EDLIN. DO YOU SEE THAT?

MR. WADE: AND THAT WAS SOMEONE WHO WORKED WITH MS. HOLMES?

MR. WADE: AND YOU SEE HERE THAT THERE WERE SOME NAMES BEING PROPOSED FOR -- TO JOIN THIS SCIENCE REVIEW COMMITTEE. DO YOU SEE THAT?

MR. WADE: AND IT SAYS HERE THAT BILL FOEGE HAD SUGGESTED THE FOLLOWING THREE PEOPLE TO BE ADDED?

MR. WADE: AND DO YOU KNOW WHO BILL FOEGE IS?

MR. WADE: AND WHO IS HE?

KINGSHUK DAS: I DON'T REMEMBER HIS TITLE, BUT WE HAD MET AT ONE OF THE ADVISORY BOARDS.

MR. WADE: OKAY. AND YOU RECALL THAT HE WAS THE FORMER HEAD OF THE CDC PREVIOUSLY?

KINGSHUK DAS: I DO BELIEVE THAT.

MR. WADE: AND HE WAS VIEWED AS A HIGHLY REPUTABLE PROFESSIONAL IN THAT SPACE; IS THAT FAIR?

MR. WADE: INFECTIOUS DISEASE AND OTHER AREAS?

MR. WADE: AND HE WAS WORKING WITH THE COMPANY DURING THIS PERIOD?

KINGSHUK DAS: THAT'S WHAT I RECALL.

MR. WADE: AND HE WAS RECOMMENDING SOME NAMES. BUT YOUR FEEDBACK -- THE FEEDBACK FROM YOU WAS SOLICITED TO MAKE SURE THAT YOU WERE COMFORTABLE WITH THE NAMES; CORRECT?

MR. WADE: OKAY. AND DID YOU RECOGNIZE THE PEOPLE WHO ARE IDENTIFIED IN THIS LIST? LET'S START WITH MR. -- I GUESS IT'S DR. TRISTRAM PARSLOW?

MR. WADE: YOU DIDN'T RECOGNIZE DR. PARSLOW?

MR. WADE: OKAY. LET'S GO TO THE NEXT PAGE. THIS IS DR. AHMED? DID YOU RECOGNIZE DR. AHMED?

MR. WADE: AND LET'S GO TO THE NEXT PAGE. DR. KESSLER? DO YOU RECALL THAT? DO YOU RECALL DR. KESSLER?

MR. WADE: OKAY. SO YOU WEREN'T PERSONALLY FAMILIAR WITH THE NAMES WHO WERE RECOMMENDED BY DR. FOEGE?

KINGSHUK DAS: THAT'S CORRECT.

MR. WADE: BUT DO YOU RECOGNIZE THEM, BASED UPON THEIR QUALIFICATIONS, TO BE HIGHLY QUALIFIED PEOPLE IN THEIR FIELDS?

MR. WADE: OKAY. YOU DID HOWEVER RECOMMEND SOME NAMES OF YOUR OWN; CORRECT?

MR. WADE: OKAY. LET'S GO UP THE EMAIL CHAIN. I'M SORRY. IF WE CAN GET THE EMAIL DOWN BELOW. IN FACT, I DON'T NEED TO DISPLAY THE EMAIL. BUT DO YOU RECALL TELLING MS. HOLMES THAT YOU WERE A LITTLE DELAYED IN GETTING TO THE EMAIL, BUT IF YOUR THOUGHTS WERE STILL NEEDED, YOU WOULD HAVE SOME ADDITIONS THAT COULD BE PROVIDED?

MR. WADE: AND MS. HOLMES SAYS PLEASE DO, ADD ANY THOUGHTS THAT YOU HAVE. DO YOU SEE THAT?

MR. WADE: AND THEN YOU, YOU PROPOSED A NUMBER OF PEOPLE WHO COULD BE ADDED TO THIS SCIENTIFIC ADVISORY BOARD; RIGHT?

MR. WADE: AND THESE WERE PEOPLE WHO YOU KNEW AND WERE FAMILIAR WITH BASED UPON YOUR WORK; RIGHT?

KINGSHUK DAS: YES, BASED UPON MY TRAINING.

MR. WADE: AND SOME OF THESE PEOPLE YOU HAD ACTUALLY TRAINED UNDER; CORRECT?

MR. WADE: AND YOU THOUGHT THEM TO BE HIGHLY QUALIFIED AND THOUGHTFUL PEOPLE; IS THAT FAIR?

MR. WADE: OKAY. AND IN PARTICULAR, DR., IS IT, GRONOWSKI?

KINGSHUK DAS: GRONOWSKI.

MR. WADE: OKAY. GRONOWSKI. IS SHE SOMEONE YOU TRAINED UNDER?

MR. WADE: AND YOU RECOMMEND THAT SHE -- SHE WAS A FORMER AACC PRESIDENT. DO YOU SEE THAT?

MR. WADE: AND THE AACC, THAT'S A -- SORT OF A TRADE GROUP OF CLINICAL CHEMISTS; IS THAT RIGHT?

MR. WADE: AND YOU RECOMMENDED THAT SHE BE CONSIDERED; IS THAT RIGHT?

MR. WADE: AND SHE ACTUALLY JOINED THE SCIENTIFIC REVIEW COMMITTEE, DID SHE NOT?

MR. WADE: AND YOU UNDERSTOOD AT THE TIME THAT THIS WAS PART OF THOSE REFORM EFFORTS THAT THE COMPANY WAS INVOLVED IN TO TRY TO GET MORE DIALOGUE AND INPUT FROM THE SCIENTIFIC COMMUNITY?

MR. WADE: I NEXT WANT TO ASK YOU BRIEFLY ABOUT YOUR TRANSITION UP AND THE WORK THAT YOU HAD BEEN DOING IN BETWEEN. THIS MUST HAVE BEEN SOMEWHAT DIFFICULT. YOUR FAMILY WAS STILL IN LOS ANGELES; RIGHT?

MR. WADE: AND YOU WERE WEARING MULTIPLE HATS AND TRYING TO MEET ALL OF YOUR RESPONSIBILITIES; RIGHT?

MR. WADE: AND SO IT WAS PROBABLY A PRETTY TAXING TIME FOR YOU; IS THAT FAIR?

MR. WADE: OKAY. BUT THERE WAS A TEAM OF PEOPLE THAT WERE WORKING ON SOME OF THE ISSUES THAT CAME UP; RIGHT?

MR. WADE: AND DR. TSCHIRHART WAS ALSO GOING TO BE COMING UP AT EXACTLY THE SAME TIME. DO YOU RECALL?

MR. WADE: AND DO YOU RECALL THAT AS PART OF -- IN ADVANCE OF YOUR COMING UP, YOU WERE COMMUNICATING WITH DR. TSCHIRHART TO KIND OF FORMULATE A PLAN AS TO HOW YOU WOULD WORK TO IMPROVE THE LAB AT THERANOS. DO YOU RECALL THAT?

MR. WADE: LET ME HAVE YOU TAKE A LOOK AT 10666.

MR. WADE: DO YOU RECOGNIZE THIS TO BE AN EMAIL CHAIN BETWEEN YOU AND DR. TSCHIRHART WITH RESPECT TO THE PLANS THAT YOU WERE PUTTING IN PLACE FOR HOW YOU WOULD IMPROVE THE LAB AT THERANOS?

(PAUSE IN PROCEEDINGS.)

MR. WADE: MOVE THE ADMISSION OF 10666.

MR. LEACH: NO OBJECTION.

JUDGE DAVILA: IT IS ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10666 WAS RECEIVED IN EVIDENCE.)

MR. WADE: AND IF WE CAN START AT THE LAST EMAIL AND FOCUS. GOOD. THANK YOU.

MR. WADE: AND IN THIS EMAIL, DR. TSCHIRHART IS REACHING OUT AND NOTES THAT HE WAS -- YOU AND HE WERE GOING TO JOIN ABOUT THE SAME TIME ON MARCH 14TH. DO YOU RECALL THAT?

MR. WADE: AND BY "FULL," THAT MEANS YOU WERE GOING TO BE PHYSICALLY ON SITE FROM THAT POINT GOING FORWARD; IS THAT RIGHT?

MR. WADE: OKAY. AND HE SAYS HE NOTES HOW THERE WOULD BE SOME BENEFITS IN TALKING ABOUT SOME OF THE PRELIMINARY ISSUES. DO YOU SEE THAT?

MR. WADE: OKAY. AND THEN IT SAYS, "OF COURSE WE WILL NEED TO REVIEW THE INSPECTION DEFICIENCY RESPONSE, AS IT WILL BE OUR BURDEN TO MAKE SURE THAT THE SPECIFIED CORRECTIVE ACTION ACTUALLY TAKES PLACE." DO YOU SEE THAT?

MR. WADE: AND HE NOTES HE WOULD LIKE TO DO THAT TOGETHER IF YOU'RE COMFORTABLE WITH THAT SO YOU COULD WORK AS A TEAM?

MR. WADE: AND I TAKE IT YOU WERE COMFORTABLE WORKING AS A TEAM WITH DR. TSCHIRHART?

MR. WADE: YOU CONSIDERED HIM TO BE A HIGHLY COMPETENT AND QUALIFIED PATHOLOGIST?

MR. WADE: OKAY. HE THEN NOTES IN THE FINAL PARAGRAPH, "THE LAST STICKY PART IS THAT BOTH OF US ANSWER DIRECTLY TO ELIZABETH; BUT AS THESE ARE ALL OPERATIONAL ISSUES, IT SEEMS TO ME THAT SUNNY SHOULD SIGN OFF ON THE CHANGES BEFORE WE GO THERE. DO YOU HAVE A FEEL FOR THIS YET?" DO YOU SEE THAT?

MR. WADE: AND DO YOU RECALL IN THIS TIME PERIOD LEARNING THAT HISTORICALLY IT HAD BEEN MR. BALWANI WHO HAD HAD THE RESPONSIBILITY OVER THE LABORATORY FROM A MANAGEMENT STANDPOINT?

MR. WADE: AND THAT THE LABORATORY DIRECTORS PREVIOUSLY HAD REPORTED UP TO MR. BALWANI?

MR. WADE: BUT AS A RESULT OF THE DESIRE TO MAKE IMPROVEMENTS AND ADDRESS SOME OF THESE REFORM EFFORTS, THAT FOR THE FIRST TIME MS. HOLMES WAS GOING TO COME IN AND HAVE THE LABORATORY DIRECTORS REPORT DIRECTLY TO HER; CORRECT?

MR. LEACH: OBJECTION. FOUNDATION. ARGUMENT.

JUDGE DAVILA: IF YOU CAN LAY A FOUNDATION FOR THAT QUESTION.

MR. WADE: WE TALKED ABOUT THE REFORM EFFORTS THAT THE LAB WAS MAKING YESTERDAY A BIT. DO YOU RECALL THAT?

MR. WADE: AND YOU RECALL THAT THAT INCLUDED HIRING NEW PEOPLE; CORRECT?

MR. WADE: AND DO YOU RECALL THAT AS PART OF THAT THERE WAS A DESIRE WITHIN THE COMPANY TO HAVE THE LABORATORY DIRECTORS REPORT DIRECTLY TO THE CEO?

MR. LEACH: OBJECTION. VAGUE, FOUNDATION.

JUDGE DAVILA: I THINK YOU CAN ASK THAT QUESTION IN A DIFFERENT WAY. YOU'RE STATING IT AS IF IT IS A FACT AND IF HE KNOWS THAT AS A FACT.

MR. WADE: FAIR ENOUGH, YOUR HONOR.

MR. WADE: DO YOU RECALL WHETHER PART OF THOSE EFFORTS WAS A DESIRE TO HAVE THE LABORATORY DIRECTORS REPORT DIRECTLY TO THE CEO AS A GOVERNANCE MATTER?

KINGSHUK DAS: NO, I WAS NOT PRIVY TO THE REASONING OF THE SWITCH IN THE CHAIN OF COMMAND.

MR. WADE: OKAY. FAIR ENOUGH. BUT YOU DO RECALL THAT WHEN YOU WERE COMING IN AS LABORATORY DIRECTOR, YOU WERE NOT GOING TO BE REPORTING TO MR. BALWANI; CORRECT?

MR. WADE: AND YOU RECALL THAT YOU WERE GOING TO BE REPORTING DIRECTLY TO MS. HOLMES?

MR. WADE: AND WAS IT YOUR UNDERSTANDING AT THE TIME THAT THIS WAS THE FIRST TIME THAT A LABORATORY DIRECTOR HAD EVER REPORTED DIRECTLY TO MS. HOLMES?

MR. WADE: I'D LIKE TO GO UP THE EMAIL AND JUST LOOK AT YOUR RESPONSE, THE EMAIL UP THE CHAIN. YOU RESPOND TO HIM WITHIN A COUPLE OF DAYS HERE, AND I JUST WANT TO FOCUS ON THAT FIRST SUBSTANTIVE PARAGRAPH. IT SAYS, THE SECOND SENTENCE, "I CAN TELL YOU THAT THE CMS DEFICIENCY RESPONSE IS QUITE COMPREHENSIVE, AND ADDRESSES ALL OF THE BASIC INFRASTRUCTURE THAT WAS MISSING (A LARGE UNDERTAKING) QUITE NICELY -- THE CLINICAL CONSULTANTS AND LEGAL TEAM DID AN OUTSTANDING JOB PUTTING IT TOGETHER - I'M MOST FAMILIAR WITH THE PATIENT IMPACT ASSESSMENTS, SINCE THAT WAS MY FOCUS." DO YOU SEE THAT?

MR. WADE: AND DOES THIS REFRESH YOUR RECOLLECTION THAT -- AS TO THE TEAM EFFORT THAT WAS UNDERWAY IN THIS PERIOD TO TRY TO RESPOND TO THE CMS ISSUES?

MR. WADE: AND SO IT WASN'T JUST YOU, IT WAS ALSO SOME MEMBERS OF THE LEGAL TEAM THAT WERE INVOLVED IN GOING THROUGH THE LEGAL ASPECTS OF THAT RESPONSE?

KINGSHUK DAS: COULD YOU CLARIFY "THE LEGAL ASPECTS OF THE RESPONSE"?

MR. WADE: WELL, THERE ARE A LOT OF REGULATIONS; CORRECT?

MR. WADE: AND THERE IS SORT OF AN ADMINISTRATIVE PROCESS THAT A COMPANY CAN GO THROUGH IN THESE MATTERS?

MR. WADE: AND THE LAWYERS WERE INVOLVED IN THAT; RIGHT?

MR. WADE: OKAY. BUT ALSO WE TALKED ABOUT YESTERDAY THEY HAD THIS BIG TEAM OF PEOPLE THAT WAS BROUGHT IN TO DIG IN ON SOME OF THE FACTS; RIGHT?

MR. WADE: AND THOSE ARE THE CLINICAL CONSULTANTS THAT YOU REFER TO IN THAT EMAIL?

MR. WADE: AND IT WAS YOUR BELIEF THAT ALL OF THESE PEOPLE WERE WORKING HARD AND IN GOOD FAITH AS THEY WERE UNDERTAKING THESE EFFORTS; IS THAT FAIR?

MR. WADE: OKAY. AND YOU NOTE THERE THAT IT WAS A LARGE UNDERTAKING. DO YOU SEE THAT?

MR. WADE: AND WE'LL TALK ABOUT THIS A BIT MORE LATER. BUT AS YOU CAME INTO THE COMPANY, YOU RECOGNIZED THERE WERE A LOT OF IMPROVEMENTS THAT WERE NEEDED AS A RESULT OF PRIORS ISSUES THAT HADN'T BEEN ADEQUATELY ADDRESSED BY PRIOR LAB DIRECTORS; IS THAT RIGHT?

MR. WADE: YOU THEN NOTE ALL OF THE SOP'S, COMPETENCIES, TRAINING HAVE BEEN ADDRESSED, HOWEVER, AS YOU KNOW, THEY WILL NEED TO BE REDUCED TO PRACTICE AND MONITORED, WHICH WILL BE JUST AS DIFFICULT EVIDENCED BY THE PROCEEDINGS IN THE RECENT MONTHLY QA/QC MEETINGS. DO YOU SEE THAT?

MR. WADE: AND SO THE PROCEDURES HAD BEEN IN PLACE, BUT YOU UNDERSTOOD AS YOU WENT IN, THERE WAS GOING TO BE A LOT OF WORK REQUIRED TO TRY TO MAKE SURE THAT THE TEAM WAS REALLY LIVING THE POLICIES?

MR. WADE: AND THAT'S IMPORTANT; CORRECT?

MR. WADE: AND BECAUSE ULTIMATELY A POLICY IS ONLY AS GOOD AS WHETHER OR NOT IT'S FOLLOWED; IS THAT RIGHT?

MR. WADE: AND AS LABORATORY DIRECTOR, YOU UNDERSTOOD THAT YOU ARE THE PERSON RESPONSIBLE TO ENSURE THAT THOSE WERE FOLLOWED; RIGHT?

MR. WADE: AND IT WAS YOUR INTENTION AT THIS POINT TO GO AND DO JUST THAT; IS THAT RIGHT?

MR. WADE: OKAY. AND YOU THEN NOTE IF THERE'S, IN THAT SECOND SENTENCE, YOU HAVE SOME TWEAKS ON QC/QA, VERIFICATION/VALIDATION THAT YOU WANT TO PUT IN PLACE, BUT THE BONES HAVE BEEN PUT IN PLACE NICELY ALREADY. DO YOU SEE THAT?

MR. WADE: SO THERE WAS PROGRESS MADE, BUT YOU STILL HAD WORK THAT YOU WANTED TO DO; IS THAT FAIR?

MR. WADE: AND THEN IF WE CAN -- YOU OFFERED TO PROVIDE DR. TSCHIRHART ANY OF THE MATERIALS OR GET HIM ANY OF THE SPECIFIC MATERIALS ON THIS IF IT WOULD BE HELPFUL TO HIM?

MR. WADE: AND YOU ALSO THEN ADDRESSED THE ISSUE WITH RESPECT TO MS. HOLMES AND MR. BALWANI A COUPLE OF PARAGRAPHS DOWN; RIGHT? LET'S PUT THAT UP. DO YOU SEE THERE ON THE PARAGRAPH IN THE SCREEN, "REGARDING SIGN-OFF BY SUNNY, THAT MAKES SENSE - I'M NOT SURE EXACTLY HOW THAT IS PLANNED. I KNOW FOR SURE THAT I REPORT DIRECTLY TO ELIZABETH, AND SOUNDS LIKE YOU DO AS WELL - BUT I'M SURE SUNNY IS INVOLVED. THAT'S PROBABLY A QUESTION BEST LEFT FOR ELIZABETH." DO YOU SEE THAT?

MR. WADE: AND, IN FACT, A SHORT TIME LATER YOU UNDERSTOOD THAT MR. BALWANI LEFT THE COMPANY; IS THAT RIGHT?

MR. WADE: AND YOU REPORTED DIRECTLY TO ELIZABETH; RIGHT?

MR. WADE: AND YOUR INTERACTIONS, AS YOU TALKED ABOUT WITH MR. LEACH, ON IMPROVEMENTS TO THE LAB WERE WITH MS. HOLMES AT THAT POINT?

MR. WADE: AND JUST SO WE'RE CLEAR ABOUT THAT, YOU WERE IN CHARGE OF THE LABORATORY; CORRECT?

MR. WADE: ARE YOU FAMILIAR WITH MS. HOLMES'S BACKGROUND AND TRAINING A BIT?

MR. WADE: AND AS YOU UNDERSTAND IT, SHE WOULDN'T BE QUALIFIED TO SERVE AS A LABORATORY DIRECTOR IN A HIGH COMPLEXITY LAB, WOULD SHE?

MR. WADE: AND THAT WAS GOING TO BE -- YOU WERE THE PERSON WHO HAD THE NECESSARY TRAINING AND EXPERTISE TO FILL THAT JOB?

MR. WADE: AND YOU WOULD BRIEF MS. HOLMES ON WHAT WAS HAPPENING AND EDUCATE HER ON DIFFERENT REQUIREMENTS AND PROCEDURES AND THE LIKE?

MR. WADE: BUT ULTIMATELY THE JUDGMENTS WERE YOURS; RIGHT?

MR. WADE: AND MS. HOLMES SUPPORTED YOU IN THAT; RIGHT?

MR. WADE: IF WE THEN GO UP THE CHAIN AND LOOK AT DR. TSCHIRHART'S RESPONSE BRIEFLY, FOCUSSING ON THE SECOND PARAGRAPH. HE TALKS ABOUT HOW HE WANTS TO GET INVOLVED AND FOCUS ON THE STRUCTURE WITHIN THE LAB AND THE REORGANIZATION AND FIGURE OUT WHAT PERSONNEL WERE RIGHT TO PUT IN PLACE; RIGHT?

MR. WADE: AND THAT'S IMPORTANT; RIGHT?

MR. WADE: YOU WERE GOING TO ULTIMATELY BE RESPONSIBLE TO A DEGREE FOR THE REACTIONS OF THE PEOPLE WHO WERE WORKING UNDER YOU; RIGHT?

MR. WADE: AND YOU WANTED, YOU WANTED COMFORT THAT THEY WERE GOOD PEOPLE WHO WERE DOING A GOOD JOB; RIGHT?

MR. WADE: OKAY. AND MS. HOLMES SUPPORTED YOU IN THAT; IS THAT RIGHT?

MR. WADE: OKAY. LET'S GO JUST TO THE CONTINUATION OF THAT, WHICH IS BACK ON THE SECOND PAGE. HE ACTUALLY -- DR. TSCHIRHART DESCRIBED THIS AS LOOKING FOR A BULLDOG. DO YOU SEE THAT?

MR. WADE: AND SOMEONE WHO WOULD REALLY DIG IN; RIGHT?

MR. WADE: AND LET'S LOOK AT YOUR RESPONSE. YOU AGREED, YOU WANTED A BULLDOG; RIGHT?

MR. WADE: AND YOU WANTED SOMEONE WHO WOULD DIG IN AND START TURNING OVER ROCKS; RIGHT?

MR. WADE: AND WHO YOU COULD TRUST TO BE THOROUGH IN EVERYTHING THEY WERE DOING; IS THAT FAIR?

MR. WADE: AND YOU IDENTIFIED THAT THERE WAS ACTUALLY A PERSON THERE ALREADY, SONIA, WHO MAY BE IN A POSITION TO SERVE THAT FUNCTION; RIGHT?

MR. WADE: AND DO YOU RECALL SONIA'S LAST NAME?

KINGSHUK DAS: CENDEJAS, I BELIEVE.

MR. WADE: SONIA CENDEJAS. BUT YOU NOTED IT WOULD TAKE SOME TIME WHEN YOU WERE ON THE GROUND TO SORT OF ASSESS THE STRENGTHS AND WEAKNESSES AND FIGURE OUT THE BEST PLAN; IS THAT FAIR?

MR. WADE: AND THEN IF YOU FOCUS ON THAT BOTTOM PARAGRAPH, DO YOU SEE IT SAYS, "ELIZABETH AND SUNNY HAVE BEEN FULLY SUPPORTIVE, SO THERE'S ABSOLUTELY NO ISSUES THERE." DO YOU SEE THAT?

MR. WADE: AND YOU BELIEVED THAT AT THE TIME; RIGHT?

MR. WADE: AND WITH RESPECT TO MS. HOLMES, WHO STAYED THERE, YOU BELIEVED THAT THROUGHOUT YOUR TENURE THERE; IS THAT RIGHT?

MR. WADE: AND YOU NOTICED THAT IN THIS PERIOD THEY SHARED OVERSIGHT AND THERE WERE NO ISSUES; RIGHT?

MR. WADE: BUT THEN AGAIN, OF COURSE, MR. BALWANI LEFT JUST A SHORT TIME AFTER THIS?

MR. WADE: OKAY. I'D LIKE TO SWITCH TO ASK YOU SOME QUESTIONS ABOUT THE CMS REPORT. AND YOU RECALL THAT MR. LEACH ASKED YOU SOME QUESTIONS ABOUT THAT YESTERDAY. AND A LOT OF THE CMS REPORT RELATED TO -- WELL, ALL OF THE CMS REPORT RELATED TO HISTORICAL ISSUES AT THE COMPANY UNDER PRIOR LABORATORY DIRECTORS; IS THAT RIGHT?

MR. WADE: AND A LOT OF THE QUESTIONS THAT YOU WERE ASKED ABOUT RELATED TO THE LAB DEVELOPED TESTS THAT WERE RUN ON THE EDISON 3.5 DEVICE. DO YOU RECALL THAT?

MR. WADE: OKAY. AND THAT WAS -- I THINK YOU SAID THERE WERE MAYBE 12 TESTS THAT WERE RUN ON THE EDISON DEVICE. DO YOU RECALL THAT?

MR. WADE: AND DO YOU RECALL LEARNING THROUGH YOUR WORK THAT THOSE WERE BROUGHT ONLINE OR VALIDATED AND PUT INTO THE LABORATORY DURING THE TENURE OF DR. ADAM ROSENDORFF?

KINGSHUK DAS: I DON'T RECALL WHOSE TENURE.

MR. WADE: WELL, DO YOU RECALL THE TENURE OF DR. ADAM ROSENDORFF?

KINGSHUK DAS: I WAS AWARE OF HIS NAME.

MR. WADE: OKAY. AND THAT HE STARTED SERVING THE LAB WHEN IT WENT LIVE FROM A COMMERCIAL STANDPOINT. DO YOU RECALL THAT?

KINGSHUK DAS: I WASN'T SURE OF THE TIMELINE.

MR. WADE: OKAY. AND LET ME JUST -- DO YOU RECALL -- LET ME STRIKE THAT. YOU RECALL COMING TO THE VIEW IN THIS TIME PERIOD THAT THE LABORATORY WAS NOT WELL RUN; IS THAT FAIR, HISTORICALLY?

MR. WADE: AND, IN FACT, THAT WAS THE REASON WHY YOU WERE WORKING TO IMPROVE IT; CORRECT?

MR. WADE: I WANT TO FOCUS A LITTLE BIT -- DO YOU RECALL THAT MR. LEACH SHOWED YOU THAT LETTER THAT TALKED ABOUT IMMEDIATE JEOPARDY? DO YOU RECALL THAT?

MR. WADE: AND THAT WAS ONE OF THE REASONS THAT PROMPTED SUCH A QUICK AND URGENT RESPONSE FROM THE COMPANY. DO YOU RECALL THAT?

MR. WADE: AND YOU TOOK THAT SERIOUSLY I TAKE IT?

MR. WADE: AND -- BUT AS YOU SIT HERE TODAY, THERE'S NO CLEAR UNDERSTANDING -- WHEN A COMPANY RECEIVES INFORMATION LIKE THAT, THERE WAS NO CLEAR UNDERSTANDING AS TO EXACTLY WHAT THAT MEANT OR EXACTLY WHAT WAS NEEDED TO RESPOND TO THAT?

MR. LEACH: OBJECTION. AMBIGUOUS. VAGUE.

JUDGE DAVILA: DID YOU UNDERSTAND THE QUESTION?

KINGSHUK DAS: I COULD USE SOME CLARIFICATION, PLEASE.

MR. WADE: FAIR ENOUGH.

MR. WADE: THE WORDS "IMMEDIATE JEOPARDY" AS APPLIED TO THE FACTS OF A LAB ARE NOT SPELLED OUT SPECIFICALLY WITHIN THAT LETTER; RIGHT?

KINGSHUK DAS: I BELIEVE THEY WERE.

MR. WADE: THE APPLICATION OF THAT DETERMINATION WAS. DO YOU RECALL THAT?

KINGSHUK DAS: I DO NOT.

MR. WADE: LET ME DO THIS, LET ME SHOW YOU A COPY OF THE REPORT.

MR. WADE: WHAT I'D LIKE TO DO IS SHOW YOU -- DO YOU RECALL YESTERDAY COUNSEL WAS DOING SOME REDACTIONS AND WAS PRESENTING YOU EXCERPTS OF THE REPORT. DO YOU RECALL THAT?

MR. WADE: OKAY. I HAVE COPIES OF THOSE, JUST THE EXCERPTS SO WE CAN ALL AVOID CONFUSION. AND I'M GOING TO HAND UP TO YOU, WITH THE COURT'S PERMISSION, A COPY OF THE LETTER THAT WAS ADMITTED AND A COPY OF THE EXCERPTS. AND I'LL PROVIDE A COPY TO COUNSEL AS WELL AND THE COURT. MAY I APPROACH, YOUR HONOR?

MR. WADE: (HANDING.) AND JUST FOR THE RECORD, I BELIEVE THESE EXCERPTS ARE ALREADY IN EVIDENCE AND HAVE BEEN MADE AVAILABLE PUBLICLY. I THINK THE LETTER WE HAVE BEEN REFERRING TO IS PART A, 4621A, AND I'LL REFER TO THE EXCERPTS FROM THE REPORT AS 4621B, WITH THE COURT'S PERMISSION.

JUDGE DAVILA: YES. THANK YOU.

BY MR. WADE:

MR. WADE: NOW, BEFORE I ASK YOU QUESTIONS ABOUT THIS, DO YOU RECALL THE GUIDELINES AND REGULATIONS THAT SET FORTH HOW A CLIA LAB OPERATES ARE SET FORTH IN THOSE -- IN THAT EXHIBIT THAT MR. LEACH WAS SHOWING YOU YESTERDAY, EXHIBIT 7603; RIGHT?

MR. WADE: AND MR. LEACH SHOWED YOU SOME SPECIFIC PORTIONS OF THAT. DO YOU RECALL?

MR. WADE: AND SOME OF THOSE RELATED TO OWNERS OF A LAB. DO YOU RECALL THAT?

MR. WADE: AND ULTIMATELY AN OWNER WHO IS NOT QUALIFIED TO SERVE AS A LABORATORY DIRECTOR CANNOT COME IN AND PERFORM THE FUNCTIONS OF A LABORATORY DIRECTOR; CORRECT?

MR. WADE: OKAY. SO THERE'S A DEGREE TO WHICH THE OWNER IS DEPENDENT UPON THE LABORATORY DIRECTOR TO TRY TO MAKE SURE THAT EVERYTHING IS DONE CONSISTENT WITH THE REGULATORY STRUCTURE; IS THAT RIGHT?

MR. WADE: AND THAT POSITION IS AN IMPORTANT JOB; RIGHT?

MR. WADE: BECAUSE THE LABORATORY DIRECTOR IN A HIGH COMPLEXITY LABORATORY IS A PERSON WHO IS HIGHLY TRAINED AND QUALIFIED; RIGHT?

MR. WADE: AND THOSE REGULATIONS PUT A LOT OF RESPONSIBILITY ON THAT PERSON TO TRY TO ENSURE THAT EVERYTHING IS DONE RIGHT; CORRECT?

MR. WADE: AND THAT'S, THAT'S MORE RESPONSIBILITY THAN ANY ONE PERSON COULD THEMSELVES ACTUALLY PERFORM; RIGHT?

MR. LEACH: OBJECTION. ARGUMENT.

JUDGE DAVILA: SUSTAINED.

BY MR. WADE:

MR. WADE: IN ORDER TO MEET ALL OF THOSE RESPONSIBILITIES, THE LABORATORY DIRECTOR NEEDS TO RELY ON OTHER PEOPLE TO PERFORM CERTAIN FUNCTIONS; RIGHT?

KINGSHUK DAS: USUALLY, YES.

MR. WADE: AND THAT'S WHY OFTENTIMES THERE ARE PEOPLE WHO ARE INVOLVED IN QUALITY ASSURANCE AND QUALITY CONTROL; RIGHT?

MR. WADE: AND THERE ARE SOMETIMES SEPARATE TECHNICAL SUPERVISORS; RIGHT?

MR. WADE: AND THERE ARE GENERAL SUPERVISORS?

MR. WADE: AND ALL OF THOSE PEOPLE HAVE TO MEET REQUIREMENTS THAT ARE SET FORTH IN THOSE REGULATIONS; RIGHT?

MR. WADE: AND WHEN WE TALKED ABOUT HIRING QUALIFIED PERSONNEL, ONE OF THE REASONS WHY YOU NEED TO DO THAT IS BECAUSE AS THE LABORATORY DIRECTOR, YOU'RE DEPENDENT UPON THOSE PEOPLE IN ORDER TO DISPATCH YOUR OBLIGATIONS; RIGHT?

MR. WADE: AND IF THEY DON'T PERFORM THEIR JOB, THERE'S A DEGREE TO WHICH YOU COULD BE HELD RESPONSIBLE FOR IT; RIGHT?

MR. WADE: OKAY. AND IN CONNECTION WITH -- AND WERE YOU AWARE WHEN YOU CAME IN THAT THE COMPANY -- YOU WERE AWARE THAT THE COMPANY HAD PRIOR LABORATORY DIRECTORS; RIGHT?

MR. WADE: AND YOU WERE AWARE THAT THEY ALSO RETAINED CONSULTING SERVICES TO ADVISE THEM ON POLICIES AND PROCEDURES AND THE LIKE?

KINGSHUK DAS: NOT UNTIL I JOINED.

MR. WADE: OKAY. WHEN YOU JOINED YOU LEARNED THAT THEY HAD GOTTEN SOME ADVICE ON THAT PREVIOUSLY?

MR. WADE: AND THAT ADVICE HAD COME FROM A GENTLEMAN NAMED JERRY HURST. DO YOU RECALL THAT?

KINGSHUK DAS: I DON'T RECALL THAT NAME.

MR. WADE: DO YOU RECALL LEARNING THAT IN ADVANCE OF THE INSPECTION THAT CMS HAD DONE, THAT THEY HAD DONE SOME MOCK AUDITS?

KINGSHUK DAS: YES, I WAS AWARE OF THAT.

MR. WADE: YES. AND THAT THEY ACTUALLY FELT THAT THE MOCK AUDITS WENT PRETTY WELL?

MR. LEACH: OBJECTION. FOUNDATION.

JUDGE DAVILA: YOU'RE ASKING HIS UNDERSTANDING OF THAT?

BY MR. WADE:

MR. WADE: DID YOU --

JUDGE DAVILA: WERE YOU AWARE OF THAT, SIR?

JUDGE DAVILA: WERE YOU AWARE OF THAT?

KINGSHUK DAS: YES, YOUR HONOR.

BY MR. WADE:

MR. WADE: OKAY. YOU WERE AWARE THAT THE MOCK AUDITS WERE THOUGHT TO HAVE GONE WELL?

KINGSHUK DAS: YES, I WAS MADE AWARE OF THOSE.

MR. WADE: BUT NEVERTHELESS, THERE WERE THESE DEFICIENCIES IDENTIFIED DURING THE INSPECTION?

MR. WADE: OKAY. AND WITHIN THE DOCUMENT THAT I'VE HANDED YOU MARKED 4621B THERE ARE, THERE ARE ISSUES THAT ARE IDENTIFIED THAT MR. LEACH WENT THROUGH. DO YOU RECALL THAT?

MR. WADE: AND I THINK THE VAST MAJORITY OF THEM RELATED TO QUALITY CONTROL. DO YOU RECALL THAT?

KINGSHUK DAS: I DON'T REMEMBER THE PROPORTION, BUT THERE WERE A NUMBER.

MR. WADE: FAIR ENOUGH. YOU RECALL A SIGNIFICANT NUMBER OF THEM RELATED TO QUALITY CONTROL?

MR. WADE: AND A QUALITY CONTROL PROCEDURE IS SOMETHING THAT A LAB DIRECTOR IS RESPONSIBLE FOR IMPLEMENTING; RIGHT?

MR. WADE: AND EITHER THE LAB DIRECTOR OR SOMEONE TO WHOM THE LAB DIRECTOR HAS DELEGATED RESPONSIBILITY IS RESPONSIBLE FOR ENSURING THAT THAT IS ENFORCED?

MR. WADE: AND TO -- AND THE PEOPLE -- AND THOSE ARE PEOPLE WHO HAVE SOME EXPERTISE; RIGHT?

MR. WADE: AND THEY'RE RESPONSIBLE FOR LOOKING AT THE DATA AND MAKING SURE THAT THE POLICY IS ADHERED TO; IS THAT RIGHT?

MR. WADE: OKAY. AND WHEN YOU LOOKED AT THAT DATA, YOU, YOU ULTIMATELY HAD, YOU ULTIMATELY CAME TO THE VIEW THAT SOME REMEDIATION WAS NECESSARY; IS THAT RIGHT?

MR. WADE: AND I WANT TO TALK A LITTLE BIT ABOUT -- I THINK WITH MR. LEACH YOU WERE ASKED SOME QUESTIONS ABOUT SOME OF THE INFORMATION THAT YOU LOOKED AT. DO YOU RECALL THAT?

MR. WADE: AND YOU, YOU -- WE WERE TALKING ABOUT BUCKETS, I THINK. DO YOU RECALL THAT?

MR. WADE: AND THERE WERE, THERE WERE THREE BUCKETS IN PARTICULAR. DO YOU RECALL?

MR. WADE: AND ONE RELATED TO THE VALIDATION OF THOSE EDISON ASSAYS; RIGHT?

MR. WADE: AND THE SECOND BUCKET RELATED TO QUALITY CONTROL RESULTS; CORRECT?

MR. WADE: AND THEN THE THIRD BUCKET RELATED TO WHAT I THINK YOU DESCRIBED AS SORT OF A PATIENT TEST RESULT DISTRIBUTION ANALYSIS; RIGHT?

MR. WADE: AND I JUST WANT TO MAKE SURE THAT WE ALL UNDERSTAND KIND OF A LITTLE BIT MORE ABOUT WHAT YOU DID AND WHAT YOU CONSIDERED THERE. OKAY?

MR. WADE: WITHIN 4621, THERE WAS SOME SPECIFIC DATA AND ITEMS THAT WERE IDENTIFIED RELATING TO QUALITY CONTROL; RIGHT?

MR. WADE: BUT YOU -- IN PERFORMING YOUR FUNCTION, YOU DIDN'T LIMIT YOURSELF TO JUST LOOKING AT THAT QUALITY CONTROL INFORMATION; RIGHT?

MR. WADE: YOU ACTUALLY ASKED FOR ALL OF THE QUALITY CONTROL INFORMATION WITH RESPECT TO EDISON ASSAYS TO BE EXTRACTED AND REVIEWED; RIGHT?

MR. WADE: AND YOU STARTED TO TURN OVER ROCKS, IF YOU WILL?

MR. WADE: AND YOU DID A RETROSPECTIVE ANALYSIS OF THE QUALITY CONTROL DATA APPLYING CERTAIN WESTGARD RULES AND PRINCIPLES TO ASSESS THE HISTORICAL QUALITY CONTROL PERFORMANCE OF THOSE EDISON ASSAYS; RIGHT?

MR. WADE: AND IN DOING THAT, YOU ASKED SOMEONE TO EXTRACT ALL OF THAT INFORMATION OUT OF THE LIS, OR LABORATORY INFORMATION SYSTEMS DATABASE; RIGHT?

KINGSHUK DAS: I'M NOT SURE WHERE THEY WOULD HAVE EXTRACTED THEM FROM BUT YES, THOSE WERE BROUGHT TO OUR --

MR. WADE: ALL OF THOSE ASSAYS?

MR. WADE: AND JUST SO WE'RE CLEAR, THERE WERE A COUPLE OF SPECIFIC EDISON DEVICES OR 3.5 DEVICES OF THERANOS THAT WERE IDENTIFIED WITHIN THIS EXCERPT OF 4621B; CORRECT?

MR. WADE: BUT THERE WERE A COUPLE HUNDRED EDISON DEVICES THAT THE COMPANY HAD AT THE TIME?

MR. WADE: AND YOU LOOKED AT ALL OF THE DATA FOR ALL OF THEM; CORRECT?

MR. WADE: AND MS. HOLMES ENCOURAGED YOU TO TURN OVER THOSE ROCKS; RIGHT?

MR. WADE: OKAY. AND WHEN YOU APPLIED THOSE WESTGARD PRINCIPLES AND LOOKED AT THE COMPANY'S HISTORIC POLICY, YOU FELT LIKE THERE WERE DEFICIENCIES?

MR. WADE: AND YOU FELT LIKE THE QUALIFIED PROFESSIONALS WHO ARE TASKED WITH MONITORING THAT BEFORE SHOULD HAVE IDENTIFIED THOSE ISSUES; IS THAT FAIR?

MR. WADE: AND PERHAPS, AS A RESULT OF THAT, SHOULD HAVE STOPPED OFFERING THOSE EDISON TESTS WHEN THEY SAW THAT DATA; IS THAT FAIR?

MR. WADE: OKAY. AND IN ADDITION TO THAT, YOU LOOKED AT, YOU LOOKED AT VALIDATION DATA FOR -- OR VALIDATION INFORMATION WITH RESPECT TO THE EDISON ASSAYS; RIGHT?

MR. WADE: AND IN CONNECTION WITH THAT VALIDATION DATA, YOU CAME TO THE VIEW THAT THE PROFESSIONALS WHO IMPLEMENTED THOSE REPORTS DIDN'T USE THE APPROPRIATE STANDARDS IN SETTING BENCHMARKS FOR THE PERFORMANCE OF THE ASSAYS; RIGHT?

KINGSHUK DAS: I DON'T REMEMBER SPECIFYING THE PROFESSIONALS, BUT IN GENERAL, YES.

MR. WADE: OKAY. FAIR ENOUGH. YOU RECALL COMING TO THE VIEW THAT THE STANDARDS THAT WERE SET FORTH FOR VALIDATION WEREN'T APPROPRIATE IN YOUR VIEW?

KINGSHUK DAS: CAN YOU CLARIFY THAT?

MR. WADE: SURE. YOU'RE AWARE THAT WHEN AN LDT IS OFFERED WITHIN A LAB, THAT TYPICALLY A VALIDATION REPORT IS PREPARED BEFORE THE LDT IS OFFERED IN THE LAB; RIGHT?

MR. WADE: AND IN CONNECTION WITH THAT VALIDATION REPORT, THERE ARE DIFFERENT STANDARDS THAT ARE SET UNDER WHICH THE ASSAY NEEDS TO PERFORM BEFORE IT CAN BE OFFERED IN THE LAB; RIGHT?

MR. WADE: AND THOSE -- THERE'S NO MAGIC LIST SOMEWHERE THAT SAYS THESE ARE THE STANDARDS FOR LDT'S THAT NEED TO BE MET; RIGHT?

KINGSHUK DAS: THERE ARE A SET OF EXPERIMENTS THAT NEED TO BE MET.

MR. WADE: THERE ARE EXPERIMENTS THAT NEED TO BE MET, BUT IN TERMS OF, FOR EXAMPLE, TOTAL ALLOWABLE ERROR, THERE ISN'T A SET LIST IN CLIA REGULATIONS THAT SAYS FOR AN LDT, THIS IS THE BENCHMARK THAT YOU NEED FOR VALIDATION?

MR. WADE: THERE'S A DEGREE TO WHICH SETTING THOSE, THE TOTAL ALLOWABLE ERROR, IS SOMETHING THAT IS WITHIN THE PROFESSIONAL JUDGMENT OF THE LABORATORY DIRECTOR?

MR. WADE: OKAY. AND, AND THAT IS USUALLY INCLUDED WITHIN THE VALIDATION REPORT, THE TOTAL ALLOWABLE ERROR?

MR. WADE: AND THAT SORT OF SETS THE FRAMEWORK FOR THE PRECISION OF THE ASSAY; IS THAT RIGHT?

KINGSHUK DAS: IT SETS A FRAMEWORK FOR ASSESSING THE ASSAY.

MR. WADE: RIGHT. AND IF -- AND IN COMING TO AND LOOKING AT THIS DATA BACK THEN, YOU LOOKED AT THE TOTAL ALLOWABLE ERROR METRICS THAT HAD BEEN SET BY THE COMPANY. DO YOU RECALL THAT?

MR. WADE: AND I'M GOING TO GO INTO THOSE IN A SECOND. BEFORE I DO, I JUST WANT TO GO INTO THE THIRD BUCKET, WHICH WAS THE PATIENT TEST DISTRIBUTION RESULTS. OKAY?

MR. WADE: AND THERE WHAT YOU DID IS FOR EACH OF THE ASSAYS YOU ESSENTIALLY PULLED OUT OF THE LIS ALL OF THE PATIENT RESULTS FOR EACH ASSAY; RIGHT?

KINGSHUK DAS: I'M NOT SURE WHERE THE DATA WAS PULLED FROM. IT WAS PULLED FOR OUR TEAM.

MR. WADE: OKAY. WHEREVER THE DATA WAS -- FOR PATIENT RESULTS WAS MAINTAINED, ALL OF THAT DATA WAS EXTRACTED; CORRECT?

KINGSHUK DAS: YES, THAT WAS TRUE TO THE BEST OF MY UNDERSTANDING.

MR. WADE: OKAY. AND YOU LOOKED AT ALL OF THE RESULTS AND LOOKED AT SORT OF WHETHER THEY -- HOW THEY PERFORMED WITHIN THE REFERENCE RANGE. IS THAT --

KINGSHUK DAS: TO SOME EXTENT.

MR. WADE: CAN YOU GIVE US A SENSE OF WHAT THE PATIENT DISTRIBUTION ANALYSIS CONSISTS OF?

KINGSHUK DAS: I'LL TRY TO AVOID JARGON AS MUCH AS POSSIBLE. IN GENERAL, WE WERE TRYING TO ASSESS HOW THE AVERAGE VALUES WERE CHANGING OR NOT CHANGING OVER TIME, WHICH IS A REFLECTION OF INACCURACY WITH THE TEST. ALSO, YOU CAN LOOK AT WHAT YOU WERE DESCRIBING, THE DISTRIBUTIONS OF ABNORMALS VERSUS NORMALS, AND GET A SENSE OF ANY SORT OF IMPRECISION IN THE ASSAY. THERE'S VARIOUS WAYS TO LOOK AT THESE METRICS. BUT, YES IN GENERAL.

MR. WADE: SO YOU ESSENTIALLY PLOT ALL OF THE RESULTS FOR THE PATIENTS AND SORT OF LOOK AT AND ANALYZE THE DATA AND CONSIDER WHETHER YOU CAN INFER ANYTHING FROM ALL OF THE RESULTS FOR THAT PARTICULAR ASSAY?

KINGSHUK DAS: TO SOME EXTENT, YES. WE MAKE CALCULATIONS BASED ON THE ENTIRE DATA SET AND LOOK AT IT IN CHUNKS. BUT, BUT OVERALL, YES.

MR. WADE: OKAY. AND THESE, THESE THREE BUCKETS THAT YOU'RE TALKING ABOUT, THIS IS A PRETTY SOPHISTICATED ANALYSIS; IS THAT FAIR?

MR. WADE: AND IT REQUIRED THE EXTRACTION OF A LOT OF DATA; RIGHT?

MR. WADE: AND IT REQUIRED THE CONSIDERATION AND ANALYSIS OF A LOT OF THAT DATA IN ORDER TO INFORM YOUR VIEWS; RIGHT?

MR. WADE: THIS IS NOT SOMETHING THAT IN YOUR VIEW SOMEONE WITHOUT KNOWLEDGE AND TRAINING WOULD BE IN A POSITION TO DO; IS THAT FAIR?

MR. WADE: OKAY. AND AS A RESULT OF THAT COMBINATION OF INFORMATION, THAT INFORMED YOUR ANALYSIS AS TO HOW TO RESPOND AND WHAT ACTIONS TO TAKE WITH RESPECT TO THE EDISON 3.5; IS THAT RIGHT?

MR. WADE: OKAY. AND I'D LIKE TO FOCUS YOU ON EXHIBIT 10678, WHICH I THINK IS THE RED WELD. MAY I APPROACH, YOUR HONOR?

BY MR. WADE:

MR. WADE: (HANDING.) DR. DAS, DO YOU HAVE EXHIBIT 10678 IN FRONT OF YOU?

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE INFORMATION THAT YOU WERE PROVIDED IN CONNECTION WITH YOUR ANALYSIS OF THAT FIRST BUCKET, THE VALIDATION BUCKET?

KINGSHUK DAS: YES, IT LOOKS FAMILIAR.

MR. WADE: I MOVE THE ADMISSION OF 10678.

MR. LEACH: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10678 WAS RECEIVED IN EVIDENCE.)

MR. WADE: IF WE CAN, LET'S JUST BLOW UP QUICKLY THE BOTTOM EMAIL.

MR. WADE: DO YOU RECALL YESTERDAY THAT WE WERE TALKING ABOUT AS YOU WERE BECOMING MORE FAMILIAR, OR AS YOU WERE FAMILIARIZING YOURSELF WITH THE COMPANY, YOU WERE TALKING WITH A VARIETY OF PEOPLE AT THE COMPANY AND ASKING THEM TO PROVIDE YOU WITH A VARIETY OF INFORMATION. DO YOU RECALL THAT?

MR. WADE: AND THAT PROCESS BECAME A LITTLE MORE EXPEDITED AS YOU WERE DEALING WITH THE CMS RESPONSE; RIGHT?

MR. WADE: AND SOME OF THE PEOPLE -- AND THIS EMAIL, MARCH 23RD, THIS IS A LITTLE OVER A WEEK AFTER YOU JOINED THE COMPANY?

MR. WADE: AND IS IT FAIR TO SAY THAT THE PEOPLE WHO ARE IDENTIFIED IN THE EMAIL ARE AMONG THE INTERNAL FOLKS AT THERANOS WHO ARE PROVIDING YOU WITH INFORMATION TO HELP GET YOU UP TO SPEED?

MR. WADE: OKAY. AND YOU WERE SENT THIS SPREADSHEET THAT INCLUDED SOME INFORMATION WITH RESPECT TO THE EDISON ASSAYS; CORRECT?

MR. WADE: AND JUST FOR CONTEXT, YOU'RE GETTING THIS INFORMATION AROUND THE TIME OF WHETHER -- OF WHEN DECISIONS ARE BEING MADE ABOUT WHETHER TO VOID THE RESULTS ON THE -- RELATING TO THE EDISON; CORRECT?

MR. WADE: OKAY. AND LET'S LOOK AT THE SPREADSHEET. AND LET'S JUST HIGHLIGHT, OR IF WE CAN ZOOM IN SO WE CAN JUST FOCUS ON THOSE FIRST FOUR COLUMNS. DO YOU SEE THAT?

MR. WADE: OKAY. AND IT IDENTIFIES THE DIFFERENT ASSAYS. DO YOU SEE THAT IN COLUMN B?

MR. WADE: AND THESE ARE ALL -- THIS IS EXCLUSIVELY THE 12 EDISON ASSAYS; RIGHT?

MR. WADE: AND THEN WE WERE JUST TALKING A LITTLE BIT ABOUT TOTAL ALLOWABLE ERROR. AND THE TOTAL ALLOWABLE ERROR, IS THAT SOMETIMES REFERRED TO AS TAE?

MR. WADE: AND DO YOU SEE THE TAE IDENTIFIED IN COLUMN E THERE?

MR. WADE: AND DID YOU UNDERSTAND AT THE TIME THAT TAE HERE REFERRED TO THE STANDARDS THAT WERE SET FOR THE VALIDATION OF THESE ASSAYS ON THE EDISON 3.5 DEVICE?

KINGSHUK DAS: I'M NOT SURE I WAS AWARE OF THAT AT THE TIME.

MR. WADE: OKAY. BUT YOU RECALL LEARNING ABOUT THE TOTAL ALLOWABLE ERROR STANDARDS THAT THE COMPANY WAS USING?

MR. WADE: AND DO YOU RECALL COMING TO THE VIEW THAT THE COMPANY, IN YOUR JUDGMENT, HAD USED THE WRONG STANDARDS FOR TOTAL ALLOWABLE ERROR IN CONNECTION WITH THE VALIDATION OF THE EDISON ASSAYS?

KINGSHUK DAS: THAT WAS NOT MY DISAGREEMENT WITH THOSE NUMBERS.

MR. WADE: WHAT WAS YOUR DISAGREEMENT?

KINGSHUK DAS: IT WAS THE WAY THAT THOSE, THOSE STANDARDS WERE USED.

MR. WADE: OKAY. EXPLAIN.

KINGSHUK DAS: SO THE TOTAL ALLOWABLE ERROR WAS PRESUMABLY SET BY THE LABORATORY DIRECTOR OR THEIR STAFF. I DIDN'T SCRUTINIZE THOSE AS MUCH AS HOW THEY WERE USED IN THE CALCULATIONS.

MR. WADE: AND HOW DID YOU SCRUTINIZE THOSE AND HOW THEY WERE USED IN THE CALCULATIONS?

KINGSHUK DAS: SO I CALCULATED WHAT ARE CALLED SIGMA METRICS. SO I'LL SPARE THE JARGON, BUT BASICALLY I SET A BASELINE TO WHICH THEY SHOULD SET THEMSELVES, OR A BENCHMARK SO TO SPEAK, WHICH WAS NOT DONE PROPERLY IN THE VALIDATION REPORTS. SO I WAS NOT SCRUTINIZING THE TAE COLUMN SO TO SPEAK, BUT MORE THE USE OF IT.

MR. WADE: RIGHT. AND I WANT TO STAY OUT OF THE COMPLEXITY. BUT ESSENTIALLY, DO YOU RECALL COMING TO THE VIEW THAT THE STANDARDS THAT WERE USED WITHIN THE VALIDATION OF THE ASSAYS WERE ESSENTIALLY TOO WIDE AND SHOULD HAVE BEEN TIGHTER?

KINGSHUK DAS: NO, THAT WAS, THAT WAS NOT MY DESCRIPTION.

MR. WADE: AND IS THERE A SIMPLIFIED DESCRIPTION OF THE CONCLUSION THAT YOU CAME TO?

KINGSHUK DAS: LET ME TRY.

KINGSHUK DAS: IT WAS AN ANALYSIS OF THE ERROR RATES THAT ENDED UP BEING TOO HIGH --

KINGSHUK DAS: -- TO BE MOST CORRECT.

MR. WADE: AND THAT WAS IN CONNECTION WITH THE VALIDATION OF THE ASSAYS?

MR. WADE: AND SO YOUR, YOUR VIEW ESSENTIALLY BECAME THAT THESE, THESE ASSAYS NEVER SHOULD HAVE BEEN OFFERED WITHIN THE CLIA LAB?

MR. WADE: BASED UPON THE STANDARDS THAT WERE USED IN THE VALIDATION?

MR. WADE: AND THAT THE VALIDATION REPORTS SHOULD NEVER HAVE BEEN SIGNED BY THE LAB DIRECTOR?

MR. WADE: OKAY. AND THAT WAS -- WITH RESPECT TO THAT BUCKET, THAT SORT OF INFORMED YOUR VIEW AS TO WHY -- THE USE OF THE WRONG STANDARDS INVALIDATING THE ASSAYS INFORMED YOUR VIEW AS TO WHY THE RESULTS NEEDED TO BE VOIDED; RIGHT?

KINGSHUK DAS: IF I MAY CORRECT YOU, IT'S THE INAPPROPRIATE USE OF THOSE STANDARDS.

MR. WADE: AND AGAIN, WITHOUT GOING INTO THE SPECIFICS, THERE WERE SORT OF CALCULATIONS THAT WERE PERFORMED WHICH CAUSED YOU TO BE OF THE VIEW THAT THE ASSAYS SHOULD NEVER HAVE BEEN VALIDATED; CORRECT?

MR. WADE: AND IT NEVER SHOULD HAVE BEEN USED WITHIN THE LAB?

MR. WADE: OKAY. AND SO THE VALIDATION OF AN ASSAY IS GENERALLY DONE WITHIN THE SET OF STANDARDS AND FRAMEWORK THAT ARE SET BY THE LAB DIRECTOR TO ASSESS WHETHER IT'S APPROPRIATE TO OFFER IT WITHIN THE CLIA LAB; RIGHT?

KINGSHUK DAS: YES. WE CALL THOSE ACCEPTANCE CRITERIA.

MR. WADE: ACCEPTANCE CRITERIA AS SET FORTH IN THE CLIA REGULATIONS I BELIEVE; RIGHT?

KINGSHUK DAS: YES, THERE ARE DIFFERENT CRITERIA, YES.

MR. WADE: AND THEN AS A COMPANY WORKS ON THE PERFORMANCE OF THE ASSAY, THEY WORK ON IT TO TRY TO MEET THAT CRITERIA; CORRECT?

MR. WADE: AND ONCE THEY MEET THE CRITERIA THAT IS SET BY THE LABORATORY DIRECTOR, THE ASSAY WILL BE VALIDATED AND THEN PERMITTED INTO THE LAB; RIGHT?

MR. WADE: AND YOUR VIEW IS ESSENTIALLY THE GATES THAT WERE SET WERE WRONG?

MR. WADE: OKAY. AND I THINK YOU TALKED ABOUT HOW YOU WENT INTO A MEETING AND THIS WAS DISCUSSED. DO YOU RECALL THAT?

MR. WADE: AND I WANT TO ASK YOU A LITTLE BIT ABOUT THAT MEETING. DO YOU RECALL THAT IN -- BEFORE I DO, LET ME JUST ASK YOU A LITTLE BIT ABOUT SOME EVENTS AROUND THAT TIME PERIOD. YOU WERE WORKING -- YOU WERE TURNING OVER ROCKS AND DIGGING INTO DATA; RIGHT?

MR. WADE: AND YOU WERE LEARNING ABOUT HOW THE COMPANY HAD VALIDATED THE ASSAYS?

MR. WADE: AND YOU WERE ALSO INTERACTING WITH FOLKS AT CMS A BIT DIRECTLY. DO YOU RECALL THAT?

KINGSHUK DAS: YES, FROM TIME TO TIME.

MR. WADE: AND LET ME -- AND THAT WAS GARY YAMAMOTO; RIGHT?

MR. WADE: AND HE WAS ONE OF THE SENIOR PEOPLE IN THE CALIFORNIA REGION?

KINGSHUK DAS: I'M NOT AWARE OF THE HIERARCHY, BUT --

MR. WADE: OKAY. AND HE WAS ONE OF THE PERSONS -- HE WAS ONE OF THE CMS EMPLOYEES WHO WAS INVOLVED IN THE INSPECTION OF THERANOS?

MR. WADE: AND THE OTHER PERSON WAS SARAH BENNETT?

MR. WADE: AND YOU INTERACTED WITH MS. BENNETT AND MR. YAMAMOTO --

MR. WADE: -- WHEN YOU CAME IN? LET'S -- AND PART OF YOUR INTERACTIONS WITH THEM, WAS THAT HELPING KIND OF INFORM HOW BEST TO RESPOND TO CMS?

MR. WADE: AND DO YOU RECALL COMING TO THE VIEW THAT THE COMPANY SHOULD TAKE A CONSERVATIVE RESPONSE -- A CONSERVATIVE POSITION IN TERMS OF HOW IT DEALS WITH PATIENTS IN A SAFE -- LET ME STRIKE THAT. YOU WANTED TO BE CONSERVATIVE, DO YOU RECALL, IN TERMS OF THE APPROACH THAT YOU WERE TAKING ON THIS?

KINGSHUK DAS: WOULD YOU MIND PROVIDING THE SPECIFICS THERE, PLEASE.

MR. WADE: SURE. LET ME SHOW YOU A DOCUMENT.

MR. WADE: THE COURT'S INDULGENCE FOR ONE SECOND? MAY I APPROACH, YOUR HONOR?

BY MR. WADE:

MR. WADE: (HANDING.) AND I PUT IN FRONT OF YOU EXHIBIT 14162. AND DO YOU RECOGNIZE THIS TO BE EMAIL COMMUNICATIONS BETWEEN YOU AND MEMBERS OF THE TEAM THAT WAS WORKING ON THE CMS RESPONSE?

MR. WADE: OKAY. MOVE THE ADMISSION OF 14162.

MR. LEACH: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 14162 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND I DRAW YOUR ATTENTION TO THE SECOND PAGE. AND DO YOU SEE THERE'S AN EMAIL FROM YOU TO OTHERS MARCH 11TH?

MR. WADE: AND DO YOU SEE THAT YOU'RE GIVING A LITTLE BIT, I GUESS, OF AN UPDATE ON SOME THINGS? DO YOU SEE THAT? OR YOUR PERSPECTIVE ON THINGS?

MR. WADE: AND YOU SEE IT SAYS, "I HAD A CHANCE TO TOUCH BASE WITH TINA AND DANIEL THE OTHER DAY TO GET DETAILS ON THE UPDATED PATIENT IMPACT ASSESSMENTS, AND I'VE DECIDED TO TAKE A MORE CONSERVATIVE APPROACH." DO YOU SEE THAT?

MR. WADE: AND IS IT FAIR -- AND WHAT DID YOU MEAN BY "CONSERVATIVE" IN THAT CONTEXT?

KINGSHUK DAS: YOU KNOW, TO THE BEST OF MY RECOLLECTION, I BELIEVE I DISAGREED WITH THE APPROACH THAT THEY WERE USING AT THE TIME.

MR. WADE: OKAY. YOU WANTED TO BE MORE CAUTIOUS; IS THAT FAIR?

KINGSHUK DAS: NO, I WOULD DISAGREE WITH THAT DESCRIPTION. I BELIEVE THEY WERE APPROACHING THE PATIENT, HOW TO USE THE SPECIAL ANALYTES TOGETHER AS OPPOSED TO SEPARATELY AS WE -- I THINK YOU CAN READ IT LATER IN THE PARAGRAPH. THAT WAS MY DISAGREEMENT.

MR. WADE: OKAY. AND YOU WERE WEIGHING IN HERE SUGGESTING THAT A DIFFERENT APPROACH SHOULD BE TAKEN; RIGHT?

KINGSHUK DAS: THAT'S CORRECT.

MR. WADE: AND SO THERE'S A -- TO THE EXTENT THAT THERE WAS A LITTLE BIT OF A DISAGREEMENT BETWEEN YOU AND SOME OF THE HISTORICAL PEOPLE WHO HAD WORKED IN THE LAB?

MR. WADE: AND YOUR APPROACH WAS FOLLOWED; CORRECT?

MR. WADE: OKAY. AND THEN YOU -- WE TALKED ABOUT YOUR THREE BUCKETS. THIS EMAIL MARCH 11TH I THINK IS JUST BEFORE YOU JOINED FULL TIME, MAYBE THE FRIDAY BEFORE?

MR. WADE: AND A SHORT TIME LATER, YOU HAD A MEETING WITH MS. HOLMES. DO YOU RECALL THAT?

KINGSHUK DAS: I DON'T RECALL THAT MEETING.

MR. WADE: WELL, YOU RECALL A MEETING WHERE THE MAIN TOPIC OF THE DISCUSSION WAS WHETHER OR NOT THE EDISON 3.5 ASSAY SHOULD BE VOIDED?

KINGSHUK DAS: YES, I RECALL THAT MEETING.

MR. WADE: OKAY. WHO DO YOU RECALL BEING PRESENT FOR THAT MEETING?

KINGSHUK DAS: THERE WERE QUITE A FEW PEOPLE IN THE ROOM. I DO REMEMBER ELIZABETH, DANIEL YOUNG, I BELIEVE THE BOIES SCHILLER LAWYERS WERE THERE AS WELL, WHICH WOULD BE DAVID ZIFKIN AND TWO OTHER LAWYERS, DR. TSCHIRHART, AND DR. HELFEND I BELIEVE. AND MAYBE OTHERS.

MR. WADE: THERE MAY HAVE BEEN OTHERS?

KINGSHUK DAS: THERE MAY HAVE BEEN OTHERS. THOSE ARE THE PRINCIPAL FOLKS THAT I REMEMBER.

MR. WADE: OKAY. IS IT FAIR TO SAY THAT THE MAIN TOPIC OF THAT MEETING WAS WHETHER THE -- ALL OF THE EDISON 3.5 RESULTS SHOULD BE VOIDED?

KINGSHUK DAS: THAT WAS THE TOPIC.

MR. WADE: OKAY. AND YOU CAME INTO THAT MEETING WITH THE VIEW THAT THEY SHOULD BE VOIDED; RIGHT?

MR. WADE: AND THERE WERE OTHER PEOPLE WHO CAME INTO THAT MEETING WITH THE VIEW THAT THEY SHOULD NOT ALL BE VOIDED; CORRECT?

KINGSHUK DAS: I DON'T KNOW THE VIEWS OF THE OTHER PEOPLE IN THE ROOM.

MR. WADE: WELL, DO YOU RECALL THAT THERE WAS DISCUSSION AND SOME DISAGREEMENT AS TO APPROACH WITHIN THE MEETING?

KINGSHUK DAS: THERE WAS NO DISAGREEMENT ABOUT VOIDING.

MR. WADE: OKAY. DO YOU RECALL THAT MS. HOLMES FULLY SUPPORTED YOUR DECISION TO VOID ALL OF THE EDISON 3.5 RESULTS?

MR. WADE: AND THIS WAS A BIG DECISION AT THE TIME; RIGHT?

MR. WADE: AT THE TIME THAT THIS WAS HAPPENING, THERE HAD BEEN A FAIR AMOUNT OF MEDIA SCRUTINY ON THE COMPANY; RIGHT?

MR. WADE: AND A FAIR AMOUNT OF CRITICISM; CORRECT?

MR. WADE: AND THIS WAS GOING TO HAVE SOME POTENTIALLY SERIOUS RAMIFICATIONS FOR THE COMPANY GOING FORWARD; RIGHT?

KINGSHUK DAS: COULD YOU CLARIFY THAT LAST POINT, PLEASE.

MR. WADE: WELL, IT WAS A BIG DECISION TO MAKE TO VOID ALL OF THE ASSAYS FOR THEIR ANALYZER; RIGHT?

MR. WADE: AND THAT WASN'T NECESSARILY SOMETHING THAT ANYONE WANTED TO DO; CORRECT?

KINGSHUK DAS: I'M NOT AWARE OF THEIR INTENTIONS OR WISHES.

MR. WADE: WELL, THE PREFERENCE WOULD BE NOT TO HAVE TO DO THAT; IS THAT FAIR?

KINGSHUK DAS: I APOLOGIZE, I CAN'T SPEAK TO WHAT THEY WOULD HAVE WANTED.

MR. WADE: FAIR ENOUGH, DOCTOR. BUT WITHIN THAT MEETING YOU WENT IN, YOU EXPRESSED YOUR VIEWS ABOUT THE EDISON 3.5, AND YOU RECOMMENDED THAT THE RESULTS SHOULD BE VOIDED; CORRECT?

MR. WADE: AND YOU RECOMMENDED THAT THE -- AND MS. HOLMES AGREED WITH THAT DECISION; RIGHT?

MR. WADE: AND THAT DECISION WAS THEN ACTED UPON VERY SHORTLY THEREAFTER; RIGHT?

MR. WADE: AND THE VOIDING WAS COMMUNICATED TO CMS; RIGHT?

MR. WADE: AND THE VOIDED RESULTS WENT OUT TO ALL OF THE PATIENTS; RIGHT?

MR. WADE: OKAY. AND YOU UNDERSTOOD THAT THAT EDISON 3.5 DEVICE AT THAT POINT HAD NOT BEEN USED FOR SOME TIME; RIGHT?

MR. WADE: THAT WAS THE, THAT WAS THE VERSION OF THE ANALYZER THAT THE COMPANY HAD STOPPED USING BEFORE YOU JOINED, YOU EVEN JOINED THE COMPANY; RIGHT?

MR. WADE: AND THERE WAS NEVER -- MR. LEACH ASKED YOU ABOUT WHETHER IT EVER CAME BACK ONLINE. DO YOU RECALL THAT?

KINGSHUK DAS: I DO RECALL THAT.

MR. WADE: AND THERE WAS ACTUALLY NEVER INTENTION TO EVER BRING THAT DEVICE BACK ONLINE AT THE TIME THAT YOU JOINED THE COMPANY; RIGHT?

KINGSHUK DAS: NOT TO MY KNOWLEDGE.

MR. WADE: AND THE COMPANY WAS ACTUALLY WORKING ON THE NEXT GENERATION DEVICE AT THE TIME THAT YOU JOINED THE COMPANY; RIGHT?

KINGSHUK DAS: I DON'T REMEMBER THE TIMELINE ON THAT, BUT I BELIEVE YOU'RE CORRECT.

MR. WADE: WELL, YOU RECALL IN THE TIME PERIOD THAT YOU WERE AT THE COMPANY THAT THERE WAS WORK BEING DONE ON THE NEXT GENERATION DEVICE?

MR. WADE: OKAY. AND YOU, YOU PLAYED SOME ROLE IN THAT DURING YOUR TENURE; RIGHT?

MR. WADE: OKAY. I BELIEVE ON DIRECT YOU TALKED A LITTLE BIT ABOUT THE PSA ASSAY AND A DISCUSSION THAT YOU HAD ABOUT THE PSA ASSAY. DO YOU RECALL THAT?

MR. WADE: OKAY. WAS THAT IN THIS MEETING OR IN A SEPARATE MEETING?

KINGSHUK DAS: IT WAS IN AN INFORMAL MEETING.

MR. WADE: IT WAS IN AN INFORMAL MEETING?

MR. WADE: AND LET ME STAY WITH THIS MEETING FOR A BIT. YOU TALKED ABOUT -- SOMETHING ABOUT MS. HOLMES REFERRING TO ONE OF HER DEPUTIES, OR SOMETHING, IN THIS MEETING AND A DIFFERENT VIEW THAT THEY EXPRESSED?

MR. WADE: WHAT DO YOU RECALL ABOUT THAT?

KINGSHUK DAS: I BELIEVE THERE WAS DISAGREEMENT ON WHY THE VOIDING WAS BEING DONE.

MR. WADE: OKAY. AND WHAT WAS MOSTLY -- AND IT WAS YOUR VIEW THAT OTHER PEOPLE WERE EXPRESSING OTHER VIEWS ON THE VOIDING AND WHY IT SHOULD BE DONE?

KINGSHUK DAS: I WAS ONLY AWARE OF THAT ONE ALTERNATE VIEW.

MR. WADE: OKAY. AND WAS THAT DR. YOUNG?

KINGSHUK DAS: I BELIEVE SO, YES.

MR. WADE: OKAY. AND HE WAS EXPRESSING A DIFFERENT REASON FOR WHY THESE RESULTS SHOULD BE VOIDED; RIGHT?

KINGSHUK DAS: I DON'T RECALL DR. YOUNG ACTUALLY VERBALIZING HIS VIEW.

MR. WADE: OKAY. AND I'M TRYING TO UNDERSTAND YOUR TESTIMONY. YOU UNDERSTOOD THAT MS. HOLMES WAS RECEIVING DIFFERENT VIEWS FROM OTHER ADVISORS?

MR. WADE: OKAY. AND THE MOST IMPORTANT THING FOR YOU COMING OUT OF THAT MEETING WAS THE VOIDING OF THE RESULTS; CORRECT?

MR. WADE: AND THAT WAS WHAT HAPPENED AND WHAT WAS AGREED TO IN THAT MEETING; RIGHT?

MR. WADE: AND THE PSA MEETING, OR PSA CONVERSATION THAT YOU HAD, I THINK YOU TALKED ABOUT HOW YOU WERE USING THAT SORT OF AS A DEVICE TO TRY TO EXPLAIN ISSUES RELATING TO THE EDISON TO MS. HOLMES. DO YOU RECALL THAT?

KINGSHUK DAS: YES, I WAS USING THAT AS AN EXAMPLE.

MR. WADE: AND MANY OF THE ANALYSES THAT YOU WERE DOING WERE PRETTY TECHNICAL IN NATURE; RIGHT?

MR. WADE: AND MS. HOLMES'S DIDN'T HAVE THAT SORT OF TECHNICAL BACKGROUND; RIGHT?

MR. WADE: AND SO YOU WERE TRYING -- AND SHE HAD NOT SUPERVISED THE LAB PREVIOUSLY TO YOUR KNOWLEDGE; RIGHT?

MR. WADE: AND SO YOU WERE TRYING TO KIND OF BRIEF HER IN ON SOME OF THESE CONCEPTS AND EXPLAIN TO HER WHY YOU CAME TO THE VIEWS THAT YOU CAME TO; IS THAT FAIR?

MR. WADE: AND SO WHILE DOING THAT, IS IT FAIR TO SAY THAT IN SOME WAY YOU WERE DESCRIBING, OR TRYING TO DESCRIBE, THESE THREE BUCKETS AND HOW YOUR VIEWS WERE INFORMED?

MR. WADE: AND YOU USED, AS AN EXAMPLE OF THAT, THE PSA ASSAY TO NOTE THAT PSA WAS DETECTED IN SOME FEMALE PATIENTS, WHICH WAS UNUSUAL; RIGHT?

MR. WADE: AND DID YOU COME TO UNDERSTAND THAT MS. HOLMES HAD PROVIDED SOME KIND OF A STUDY BY ANOTHER ADVISOR THAT SUGGESTED THAT PSA COULD SOMETIMES BE DETECTED IN FEMALES?

KINGSHUK DAS: SHE BROUGHT THAT INFORMATION AT A LATER TIME POINT.

MR. WADE: OKAY. SOME SORT OF ACADEMIC RESEARCH OR THE LIKE. DO YOU RECALL?

KINGSHUK DAS: I BELIEVE IT WAS EITHER AN ARTICLE OR AN ABSTRACT THAT SHE HAD FOUND.

MR. WADE: OKAY. AND ARE YOU AWARE THAT THERE ARE ENDOCRINOLOGISTS WHO HAVE DETECTED PSA IN FEMALES ON OCCASION?

KINGSHUK DAS: YES, ON OCCASION.

MR. WADE: AND YOU CAME TO THE VIEW THAT THAT WASN'T A PLAUSIBLE EXPLANATION FOR THE DATA ANALYSIS THAT YOU WERE DOING; CORRECT?

MR. WADE: AND THAT DISCUSSION THAT YOU HAD ABOUT THAT INFORMATION, THAT DIDN'T ALTER THE COURSE OF ACTION THAT THE COMPANY WAS TAKING WITH RESPECT TO THE ASSAYS IN ANY WAY; RIGHT?

MR. WADE: AND YOU STILL VOIDED ALL OF THE PSA ASSAYS; RIGHT?

MR. WADE: AND THIS WAS PART OF THE DISCUSSION WHERE YOU, AS THE EXPERT IN THE FIELD, WERE TRYING TO --

MR. LEACH: YOUR HONOR, I'M SORRY TO INTERRUPT, BUT THE JUROR IS RAISING HER HAND.

JUROR: COULD WE TAKE A BREAK? I NEED TO USE THE RESTROOM.

JUDGE DAVILA: SURE. SURE. LET'S TAKE A BREAK NOW. COULD WE TAKE A BREAK NOW? WOULD THIS BE A GOOD TIME FOR OUR 30 MINUTE RECESS?

JUDGE DAVILA: LET'S TAKE A BREAK, AND WE'LL RESUME IN 30 MINUTES. THANK YOU.

KINGSHUK DAS: THANK YOU.

(JURY OUT AT 10:30 A.M.)

JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. YOU CAN STAND DOWN, DOCTOR. THANK YOU. ANYTHING FURTHER BEFORE WE BREAK?

MR. LEACH: NO, YOUR HONOR.

JUDGE DAVILA: ALL RIGHT.

MR. WADE: NO, YOUR HONOR.

JUDGE DAVILA: ALL RIGHT. THANK YOU.

(RECESS FROM 10:31 A.M. UNTIL 11:03 A.M.)

JUDGE DAVILA: LET'S GO BACK ON THE RECORD. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. WE'RE OUTSIDE OF THE PRESENCE OF THE JURY. MR. BOSTIC, YOU WANTED TO TALK ABOUT THE NEXT WITNESS?

MR. BOSTIC: YES. THANK YOU, YOUR HONOR. THE GOVERNMENT'S NEXT WITNESS IS ALAN EISENMAN. I BELIEVE THE DEFENSE MIGHT HAVE SOME QUESTIONS FROM THE COURT OR MIGHT BE SEEKING SOME GUIDANCE ON SOME ISSUES WE PREVIOUSLY TALKED ABOUT, BUT I'LL LET MR. DOWNEY ADDRESS THAT. THE GOVERNMENT WANTED TO RAISE WITH THE COURT THE ISSUE OF AN OUT OF COURT COMMENT BY THIS WITNESS. I UNDERSTAND THE COURT IS AWARE. I HAVE DISCUSSED THE MATTER WITH DEFENSE COUNSEL. MY UNDERSTANDING IS THAT THE DEFENSE COUNSEL MAY DECIDE TO RAISE THAT TOPIC IN THE CROSS OF THIS WITNESS. MY CONCERN, IF SO, WOULD BE MAKING SURE THAT THE COURT'S ORDER REGARDING MENTIONING PUNISHMENT IN FRONT OF THE JURY IS COMPLIED WITH. SO I WANTED TO MAKE SURE THAT WE HAD AN OPPORTUNITY TO UNDERSTAND THE BOUNDARIES OF THAT EXAMINATION, IF NECESSARY.

JUDGE DAVILA: SURE. OKAY. THANK YOU.

MR. DOWNEY: WELL, YOUR HONOR, I THINK I WAS REALLY INTENDING, IN TERMS OF THE CONTENT OF THE WITNESS'S COMMENT OUTSIDE OF COURT, JUST TO ASK HIM WHETHER HE MADE THE COMMENT OR NOT, AND NOT BEYOND THAT. I DON'T THINK -- I THINK IT'S AN IMPORTANT ELEMENT OF CONFRONTING THIS WITNESS POTENTIALLY DEPENDING ON HIS TESTIMONY ON DIRECT. THERE'S NOT A REFERENCE TO A PARTICULAR TERM OR A PARTICULAR PUNISHMENT. I THINK IN GENERAL TERMS IT WON'T INTRUDE ON THAT -- ON THE COURT'S INSTRUCTION ON PUNISHMENT, WHICH I ANTICIPATE IT WILL GIVE, AS IT ALWAYS DOES. SO I DON'T THINK THERE'S ANY ISSUE PRESENTED. I DON'T MEAN TO GO BEYOND WHAT THE WITNESS SAID.

JUDGE DAVILA: SO IS IT YOUR INTENT -- OR AS YOU LOOK AT IT TODAY, YOUR INTENT WOULD BE TO ASK HIM, DID YOU SAY X?

MR. DOWNEY: EXACTLY.

JUDGE DAVILA: AND HE'LL RESPOND. AND WHAT WILL YOU DO WITH THAT?

MR. DOWNEY: WELL, I -- WHATEVER I DO WITH IT, IT'S NOT GOING TO BE TALKING ABOUT THE SENTENCING GUIDELINES WITH HIM GETTING INTO PARTICULAR PUNISHMENT. SO I DON'T THINK MR. BOSTIC'S CONCERN IS REALLY GOING TO BE MADE RIPE I THINK AT THIS POINT.

JUDGE DAVILA: THANK YOU FOR THAT. I SUPPOSE THAT COULD BLEED INTO -- IT MIGHT BE A BIAS ISSUE OR SOMETHING LIKE THAT.

JUDGE DAVILA: BUT IT COULD BLEED INTO SOMETHING ELSE THAT I'LL JUST SAY I'LL HAVE TO SCRUTINIZE AT THE TIME.

MR. DOWNEY: WELL, YOUR HONOR, I DON'T WANT THE WITNESS'S, YOU KNOW, OUT OF COURT BEHAVIOR, WHICH IS INAPPROPRIATE IN MY VIEW, I DON'T WANT TO ALLOW THAT TO BECOME AN INVITATION TO HIM TO SORT OF NARRATE HIS GRIEVANCES ON REDIRECT, FOR EXAMPLE.

MR. DOWNEY: SO, YOU KNOW, MY CONCERN IS ONLY TO DEMONSTRATE THAT HE'S ARTICULATED THAT PARTICULAR AGENDA BEFORE TESTIFYING AND NOT REALLY BEYOND THAT. BUT I DON'T WANT HIM TO BE PERMITTED ON REDIRECT TO SAY THINGS HE OTHERWISE WOULD NOT BE PERMITTED TO SAY IN TERMS OF MAKING CLAIMS ABOUT MS. HOLMES. SO I, I -- IF THE COURT WERE TO INDICATE IT'S GOING TO ALLOW THAT, I PROBABLY WOULD REFRAIN FROM THAT QUESTIONING, BUT I THINK THAT WOULD BE HIGHLY INAPPROPRIATE.

JUDGE DAVILA: WELL, I DON'T. HIS -- A WITNESS'S BIAS, IF ANY, IS ALWAYS RELEVANT AS WE KNOW. AND WE KNOW THERE WAS THIS STATEMENT THAT WAS OBSERVED BY INDIVIDUALS. HAVE YOU SATISFIED REVIEWING THAT WITH MR. SCHENK?

MR. DOWNEY: WELL, I HAVE NOT YET HAD THE OPPORTUNITY TO REVIEW WHAT MR. SCHENK AND I WERE INTENDING TO REVIEW.

MR. DOWNEY: AS OF THIS MORNING, I THINK MR. SCHENK HAS STILL NOT BEEN APPRISED OF WHEN THAT MIGHT BE POSSIBLE.

JUDGE DAVILA: OKAY. WELL, WE -- MR. BOSTIC?

MR. BOSTIC: I'M SORRY. TWO POINTS IN RESPONSE TO THE ARGUMENTS BY MR. DOWNEY. FIRST, AS TO THE CONTENT OF THE STATEMENT, I DON'T THINK THAT -- EVEN PUTTING THE CONTENT OF THE STATEMENT IN FRONT OF THE JURY I THINK IS IN CONFLICT WITH OR IN SEVERE TENSION WITH THE COURT'S ORDER ABOUT MENTIONING PUNISHMENT IN FRONT OF THE JURY. THAT RULE AND THE COURT'S ORDER DOESN'T SAY ANYTHING ABOUT, WELL, YOU CAN MENTION PUNISHMENT OR THE NATURE OF THE PUNISHMENT, JUST NOT THE LENGTH OF THE TERM OR ANYTHING SPECIFIC. IT'S MORE GENERAL THAN THAT, AND FOR GOOD REASON. I THINK THE PARTIES HAVE BEEN CAREFUL THUS FAR NOT TO MAKE COMMENTS, ANY OF WHICH WOULD BE SPECULATIVE, BY THE WAY, ABOUT WHAT ANY SENTENCE MIGHT BE OR THE FORM IT MIGHT TAKE. SO I THINK TO PUT THAT CONCEPT IN FRONT OF THE JURY FOR THE FIRST TIME I THINK WOULD BE CROSSING A LINE THAT WE HAVE NOT YET CROSSED AND SHOULDN'T BE CROSSED. I THINK THERE'S A WAY TO EXPLORE THAT SAME ISSUE BY SIMPLY REMOVING THAT CONCEPT FROM THE COMMENT AND DESCRIBING IT IN TERMS OF A DESIRE ABOUT THE OUTCOME OF THE CASE OR ABOUT THE JURY'S VERDICT. I THINK THERE'S A WAY TO DO THAT WITHOUT MENTIONING THE NATURE OF ANY POTENTIAL PUNISHMENT THAT IS IN GREATER COMPLIANCE WITH THE COURT'S ORDER.

JUDGE DAVILA: WELL, THANK YOU. AGAIN, IT'S ONE OF THE MANY THORNY ISSUES THAT HAVE COME UP IN THIS CASE. IT'S -- AND WE HAVE NO CONTROL OVER WHAT THIS WITNESS'S RESPONSE IS. I'M NOT GOING TO ASK THE GOVERNMENT TO TELL ITS WITNESS WHAT TO SAY AND WHAT NOT TO SAY, NOR AM I GOING TO TELL YOU, MR. DOWNEY, THAT. WE HAVE TO BE VERY CAREFUL ABOUT -- YOU KNOW WHAT THE RULE IS. YOU KNOW I'VE SAID WE'RE NOT GOING TO MENTION PUNISHMENT AND WE'RE NOT GOING TO GET THAT OUT OF ANY WITNESS. THIS STATEMENT WAS NOT A STATEMENT THAT WAS ELICITED BY A COUNSEL AT ALL. IT WAS A STATEMENT THAT APPARENTLY THIS WITNESS MADE UPON ENTERING THE COURT. IT PERHAPS TOUCHES ON HIS BIAS, HIS PERSONAL FEELINGS. I DON'T KNOW, MR. DOWNEY, IF YOU CAN ASK A QUESTION THAT AVOIDS THAT. I DON'T KNOW WHAT THE VALUE IS OF GETTING THE ACTUAL PUNISHMENT TYPE IN AS OPPOSED TO GETTING IN, YOU KNOW, YOU HAVE CERTAIN FEELINGS ABOUT WHAT SHOULD HAPPEN IN THIS CASE.

MR. DOWNEY: WELL, I DON'T KNOW THAT I CAN DO THAT, YOUR HONOR. I MEAN, I THINK THE STATEMENT REVEALS THE SEVERITY OF THE AGENDA THAT HE'S BRINGING IN TO TESTIFY. I'M NOT SURE THAT REALLY A RESTRICTION ON SORT OF A GENERAL CONCEPT OF SENDING A WITNESS -- SENDING A DEFENDANT TO PRISON OR JAIL WOULD ACTUALLY BE CONSISTENT WITH THE CONFRONTATION CLAUSE. I THINK AS YOU GET INTO MORE DETAIL ABOUT THAT, YOU KNOW, THE CASES TEND TO RESTRICT IT. BUT I DON'T WANT TO -- AT THIS POINT, I DON'T WANT TO BE UNDER ANY RESTRICTION, YOU KNOW, AND WE'LL SEE HOW IT GOES. I MEAN, I HAVE TO ASSESS THE WITNESS OBVIOUSLY.

JUDGE DAVILA: NO. SURE. AND YOU HAVEN'T SEEN --

MR. DOWNEY: I HAVEN'T SEEN HIM AND SEEN THE TAPE.

JUDGE DAVILA: AND I DON'T KNOW IF THERE'S VIDEO OR AUDIO ON THAT TAPE OR WHATEVER. ALL RIGHT. WELL, THANK YOU FOR RAISING IT. I DO HAVE SOME CONCERNS ABOUT THAT. ON THE OTHER HAND, THE WITNESS SAID WHAT HE ALLEGEDLY SAID, AND I DO THINK IT'S APPROPRIATE TO INQUIRE ON THAT. BUT YOU CAN'T GO INTO ANY DETAIL ON THAT. YOU REALLY CAN'T. AND IT WILL MOST LIKELY BE, IF SOMETHING COMES UP ABOUT THAT, I WILL, ONCE AGAIN, TELL THIS JURY THAT THEY'RE NOT TO CONSIDER PUNISHMENT IN ANY WAY, IN ANY FASHION AT ALL. AND I MIGHT DO THAT WHILE THIS WITNESS IS ON THE STAND. BUT, YOU KNOW, TO PROBE IT ANY FURTHER THAN THAT, OF COURSE --

MR. DOWNEY: WELL, AS I'VE SAID, I DON'T INTEND TO PROBE IT ANY FURTHER THAN THAT, BUT I THINK THAT'S SORT OF PRECISELY WHERE THE LINE HAS BEEN WHERE I'M BALANCING THE PRINCIPLE YOUR HONOR IS ARTICULATING WITH THE RIGHT TO DEMONSTRATE A WITNESS'S BIAS.

MR. BOSTIC: YOUR HONOR, JUST ON THAT, I WOULD ASK, IF THE DEFENSE IS ALLOWED TO GO INTO THE CONTENT OF THAT QUESTION, THE GOVERNMENT BE ALLOWED A REASONABLE AMOUNT OF LATITUDE TO FOLLOW UP, AGAIN, NOT GOING DEEPER INTO THE PROBLEMATIC AREAS, BUT TO ASK THIS WITNESS, YOU KNOW, FOR EXAMPLE, WHETHER THAT FEELING AFFECTED HIS TESTIMONY OR THE -- YOU KNOW, INTERFERED WITH HIS ABILITY TO ANSWER QUESTIONS DURING DIRECT.

JUDGE DAVILA: I THINK THIS WITNESS HAS BEEN IDENTIFIED BY THE GOVERNMENT AS A VICTIM.

JUDGE DAVILA: AND AS A VICTIM, HE MAY HAVE SOME STATEMENTS ABOUT WHAT HAPPENED TO HIM AND HOW HE FEELS, AND THAT'S, THAT'S -- WITHIN CERTAIN REASON, THAT'S PERMISSIBLE. BUT THIS WHOLE OTHER ISSUE IS SOMETHING THAT YOU BOTH HAVE TO TREAD VERY LIGHTLY ON.

MR. DOWNEY: WELL, YOUR HONOR, I DON'T WANT TO LET YOUR COMMENT GO, BECAUSE TO MY MIND, I DON'T THINK THE WITNESS SHOULD GET A GOLD STAR FOR THIS BEHAVIOR AND BE ALLOWED TO SAY, BOY, BECAUSE I'VE BEEN DEFRAUDED, I WANT HER TO GO TO PRISON. THAT SEEMS TO ME LIKE IT WOULD BE WILDLY INAPPROPRIATE.

JUDGE DAVILA: WELL, IF HE SAYS THAT, IF HE SAYS, I SAID WHAT I SAID BECAUSE SHE, YOU KNOW -- PARDON ME -- STOLE MONEY FROM ME AND I BELIEVE PEOPLE WHO STEAL SHOULD GO TO PRISON, I DON'T KNOW, HE MIGHT SAY SOMETHING LIKE THAT.

MR. BOSTIC: YOUR HONOR, THAT'S THE KIND OF TESTIMONY, OF COURSE, THE GOVERNMENT WOULD NEVER SEEK TO ELICIT ON DIRECT OR ON REDIRECT. BUT THAT'S PART OF MY CONCERN HERE IS THAT IF WE GO INTO THAT TOPIC, WE'RE NOT SURE WHAT THE WITNESS WILL SAY ON CROSS. AND ON DIRECT I FEEL LIKE IT WILL OPEN THE DOOR TO SOME APPROPRIATE LEVEL OF QUESTIONING ABOUT THE MOTIVE FOR THAT STATEMENT, WITHIN REASON.

JUDGE DAVILA: WELL, AND THAT'S THE THING, TOO, IS THAT A WITNESS, A VICTIM MIGHT SAY, WELL, YEAH, I'M UPSET BECAUSE I LOST MONEY, OR WHATEVER THE WITNESS MIGHT SAY. I THINK THAT'S SOMETHING THAT WE COULD EXPECT IN THE HUMAN EXPERIENCE. SOMEONE -- PARTICULARLY BASED ON WHAT WE KNOW ABOUT WHAT WAS SAID HERE, WE MIGHT ANTICIPATE THAT. SO WE'RE ALL GOING TO BE -- HAVE TO BE ON GUARD TO SHUT THAT DOWN AS BEST WE CAN FOR BOTH SIDES' REASONS. SOME OF THIS IS -- THE BIAS, THAT'S ALWAYS RELEVANT FOR A WITNESS. THE WITNESS, HIS STATEMENT, THE REASONS WHY HE SAYS WHAT HE DOES, BECAUSE HE FEELS HE'S A VICTIM, THAT HAPPENS IN CRIMINAL TRIALS FREQUENTLY. BUT THERE'S LIMITS TO THAT, OF COURSE. OKAY.

MR. DOWNEY: YOUR HONOR, JUST A MORE MEAT AND POTATOES ISSUE.

MR. DOWNEY: WE HAD DISCUSSED MANY MOONS AGO WHEN THIS WITNESS WAS ANTICIPATED THAT I HAD ASKED FOR SOME RESTRICTIONS ON PORTIONS OF DOCUMENTS, AND I THINK YOUR HONOR HAD DISAGREED WITH ME ON ONE FRONT AND AGREED ON ANOTHER FRONT. AND THERE ARE FOUR EXHIBITS THAT ARE AFFECTED BY THAT, AND I THOUGHT, SINCE I'LL BE MENTIONING THAT WHEN THE WITNESS IS ON DIRECT, I MIGHT JUST GIVE THE COURT THOSE EXHIBITS.

MR. DOWNEY: BUT I WILL HIGHLIGHT TO MR. BOSTIC AS WELL. THEY ARE 2216. THE COURT HAD REJECTED ONE OF MY SUGGESTIONS, BUT ACCEPTED ANOTHER ONE, AND THAT IS ON THE FIRST PAGE AND IT'S HIGHLIGHTED HERE.

JUDGE DAVILA: DO YOU WANT ME TO LOOK AT THIS?

MR. DOWNEY: JUST -- I THINK THAT, I THINK THAT IS CONSISTENT WITH THE DIRECTION, BUT YOU MIGHT WANT TO CONFIRM IT AND HAVE IT SO IF THE ISSUE COMES UP. AND THEN --

MR. BOSTIC: COUNSEL, I'M SORRY. IF WE COULD JUST TAKE THESE ONE BY ONE VERY BRIEFLY?

MR. BOSTIC: AS TO 2216, YOUR HONOR, MY UNDERSTANDING FROM OUR PREVIOUS DISCUSSION IS THAT THERE'S A LINE IN MR. EISENMAN'S EMAIL THAT SAYS -- SORRY. THERE'S A LINE ON PAGE 1 OF 2216, AN EMAIL FROM MR. EISENMAN SAYS, "I HAVE MOST OF MY NET WORTH IN YOUR COMPANY." I REMEMBER THE COURT HAD CONCERNS ABOUT THAT LINE. THE GOVERNMENT'S INTENTION IS TO REDACT THAT FROM THE --

MR. DOWNEY: OKAY. THAT'S FINE. THAT'S GOOD WITH ME. AND THEN ON 2648, I THINK THE COURT --

MR. DOWNEY: 2468, WE HAD A SIMILAR CONCERN, AND I THINK YOU HAD PERMITTED THE GOVERNMENT TO INCLUDE THE DIFFERENT STAGE OF LIFE LANGUAGE ON THE FIRST PAGE, SO I WAS UNSUCCESSFUL THERE. BUT THEN THERE'S A REFERENCE ON THE SECOND PAGE TO THE GRANDDAUGHTER BEING BORN AND HIS RETIREMENT AND SO FORTH.

MR. DOWNEY: I DON'T KNOW WHAT THE COURT'S INTENTION IS WITH RESPECT TO THAT, BUT I HAVE HIGHLIGHTED WHAT BOTHERS ME THERE.

MR. BOSTIC: I INTEND TO INTRODUCE THAT EXHIBIT AS IS, YOUR HONOR. I DON'T THINK THAT HAS ANYTHING TO DO WITH THE KINDS OF ISSUES THAT THE COURT WOULD SEEK TO LIMIT IN TERMS OF DOWNSTREAM HARM. THIS IS SIMPLY AN EXPLANATION FROM THIS WITNESS ABOUT WHY HE WAS SEEKING ADDITIONAL INFORMATION FROM THE COMPANY.

JUDGE DAVILA: DO YOU HAVE A COPY? I DIDN'T BRING IT UP WITH ME HERE. I'M SORRY.

MR. DOWNEY: YES, I DO, YOUR HONOR.

JUDGE DAVILA: THANK YOU.

MR. DOWNEY: LET ME JUST ELIMINATE ONE OF THESE.

MR. BOSTIC: YOUR HONOR, MY UNDERSTANDING FOLLOWING OUR LAST CONVERSATION WAS THAT THE LINE THAT I MENTIONED REDACTING WAS THE ONLY LINE THAT THE COURT WAS INCLINED TO REDACT. BUT WE'RE, OF COURSE, INTERESTED IN ANY FURTHER GUIDANCE THE COURT HAS.

JUDGE DAVILA: THAT WAS IN 2216?

MR. BOSTIC: YES, YOUR HONOR.

MR. DOWNEY: AND 2468, IT'S REALLY THE TOP OF THE SECOND PAGE WHICH IS HIGHLIGHTED WHICH IS THE REFERENCE TO A BABY AND SO FORTH.

(HANDING.)

(PAUSE IN PROCEEDINGS.)

JUDGE DAVILA: THE FIRST LINE ON PAGE 2?

MR. DOWNEY: THAT'S RIGHT.

(PAUSE IN PROCEEDINGS.)

JUDGE DAVILA: SO IF THAT LINE IS REDACTED, THEN WHAT REMAINS IS, "WE ARE BOTH CONSIDERING." THIS CONVERSATION SEEMS TO INCLUDE THE DAUGHTER.

MR. BOSTIC: YOUR HONOR, I JUST DON'T THINK THAT'S ANYWHERE NEAR THE STANDARD OF WHAT NEEDS TO BE EXCLUDED UNDER 403.

MR. DOWNEY: WELL, I THINK WE'RE AGREED, MAYBE WE'RE NOT, BUT I THINK WE'RE AGREED THAT WHAT A PURPORTED VICTIM DOES WITH THE PROPERTY THAT IS THE SUBJECT OF THE WIRE FRAUD CHARGE IS POTENTIAL 403 MATERIAL AND NOT RELEVANT. I WOULD SAY THIS IS HIGHLY INFLAMMATORY IN THE SENSE THAT WHATEVER THE TRUTH OF THE ASSERTION IS, YOU KNOW, THE SENSE OF IT IS THAT THE IMPACT IS BEING VISITED ON HIS GRANDDAUGHTER.

JUDGE DAVILA: HIS DAUGHTER. AND IF IT READ, IN ADDITION TO THE FACT I'M RETIRING, AND THEN ALL OF THAT BALANCE IS REDACTED, PERHAPS THAT SOLVES IT. BUT I STILL HAVE A PROBLEM WITH THE CONTEXT, BECAUSE THEN IT REFERS TO "WE."

MR. BOSTIC: YOUR HONOR, I'LL JUST POINT OUT THIS IS ALL BEFORE ANY MONEY WAS ACTUALLY LOST. SO IT WOULD BE ONE THING IF THE WITNESS HAD LOST THE MONEY, WAS AT THIS TIME A VICTIM OF A COMPLETED FRAUD, AND WAS SAYING, HERE'S HOW THIS HURT ME, HERE'S HOW THIS HURT MY FAMILY. THAT'S NOT AT ALL WHAT IS HAPPENING HERE. INSTEAD, THIS WITNESS IS SAYING, AS THE COURT NOTED BEFORE, MY LIFE CIRCUMSTANCES HAVE CHANGED AND HERE'S WHY I'M EVALUATING WHAT TO DO WITH THIS INVESTMENT, THIS IS WHY I WOULD LIKE MORE INFORMATION ABOUT THE COMPANY.

MR. DOWNEY: ON THAT POINT, YOUR HONOR, HE'S OBVIOUSLY TYING THESE ISSUES TO THE INVESTMENT, WHICH THE BALANCE OF HIS TESTIMONY IS GOING TO SUGGEST, YOU KNOW, HE LOST SO MUCH. I DON'T THINK THE DISTINCTION IS AS SIGNIFICANT AS MR. BOSTIC SUGGESTS, BUT --

JUDGE DAVILA: THANK YOU. I THINK AT LEAST I'M TRYING TO PUT MYSELF IN YOUR SHOES, MR. DOWNEY, AND I THINK THE MOST TROUBLING PART OF THIS IS "RECENTLY HAD A BABY."

MR. DOWNEY: FOR SURE.

JUDGE DAVILA: "AND NEEDS LIQUIDITY." AND I THINK IF IT READ, IN ADDITION TO THE FACT THAT I'M RETIRING, MY DAUGHTER KELLY EITHER NEEDS -- AND STRIKE THE "RECENTLY HAD A BABY" PART -- NEEDS LIQUIDITY TO BUY A HOUSE AND WE'RE BOTH CONSIDERING --

MR. DOWNEY: THAT'S FINE, YOUR HONOR. THAT SOUNDS LIKE A SENSIBLE LINE.

JUDGE DAVILA: SO WE'LL STRIKE THE "RECENTLY HAD A BABY" --

MR. DOWNEY: THAT'S FINE.

JUDGE DAVILA: -- UNDER 403. AND THEN THE CONTEXT, OR AT LEAST THE GRAMMAR, THE REMAINING WOULD BE CONSISTENT.

MR. BOSTIC: UNDERSTOOD, YOUR HONOR.

JUDGE DAVILA: AND YOU'LL DO THE BEST THAT YOU CAN TO NOT HAVE HIM TALK ABOUT HIS GRANDDAUGHTER.

MR. BOSTIC: I WON'T INTENTIONALLY ELICIT THAT, YOUR HONOR.

JUDGE DAVILA: LET ME RETURN THESE TO YOU BOTH (HANDING).

MR. DOWNEY: THANK YOU, YOUR HONOR. AND THE LAST ISSUE RELATES TO ANOTHER ISSUE ON WHICH THE COURT HAS ALREADY RULED, BUT I JUST WANTED TO IDENTIFY TWO OF THE DOCUMENTS, AND THERE'S ALSO A BIT OF A DISCUSSION ABOUT THE GRANDDAUGHTER IN THESE AS WELL, 1371 AND 1663. I'LL HAND THOSE UP. I HAD REQUESTED THAT MR. BOSTIC BE PRECLUDED FROM ELICITING FROM THE WITNESS DETAILS ABOUT DISCUSSIONS OF AN IPO IN THE 2006 TO 2010 TIMEFRAME. I THINK THE COURT SUGGESTED IT WAS MORE INCLINED TO GIVE AN INSTRUCTION IN CONNECTION WITH THAT. I THINK -- OUR POSITION IS I THINK THAT IT IS WELL BEYOND THE SCOPE OF A WIDELY CHARGED CASE, BOTH IN TIME AND SUBSTANCE, AND SO WE WOULD LIKE TO HAVE IT EXCLUDED. BUT IN ANY EVENT, IF THE COURT WERE TO AGREE WITH US, THAT REFLECTS WHERE THE REDACTIONS WOULD BE.

JUDGE DAVILA: ALL RIGHT. THIS IS ON -- SHOULD WE LOOK AT 1371 FIRST?

JUDGE DAVILA: AND IS THE FIRST REDACTION ON PAGE 12? NO. IT LOOKS LIKE --

MR. DOWNEY: YEAH, THERE ARE SOME TELEPHONIC REDACTIONS BEFORE THEN, BUT --

JUDGE DAVILA: IT LOOKS LIKE IT'S PAGE 9.

MR. DOWNEY: YEAH, I THINK ON PAGE 9 THE COURT HAS EFFECTIVELY NOT ACCEPTED THAT REDACTION BY ITS RULING ON THE OTHER DOCUMENTS. I THINK ON PAGE 10 THERE ARE TWO REDACTIONS, ONE OF WHICH TOUCHES ON THE BABY.

JUDGE DAVILA: WE JUST COVERED THAT, DIDN'T WE?

MR. DOWNEY: YEAH, I THINK THAT'S THE SAME EMAIL.

MR. DOWNEY: BUT IT WOULD BE REDACTED HERE.

MR. BOSTIC: SORRY TO INTERRUPT, COUNSEL. I ONLY INTEND TO INTRODUCE PAGES 1 THROUGH 8.

MR. DOWNEY: ALL RIGHT. WELL, THAT SOLVES THE PROBLEM.

MR. BOSTIC: JUST TO SAVE US SOME TIME.

JUDGE DAVILA: THANK YOU, MR. BOSTIC. LET'S MOVE TO 663.

MR. DOWNEY: AND THIS IS A DISCUSSION I THINK, YOUR HONOR, EXCLUSIVELY UNDER THE COURT'S RULING THAT TOUCHES ON THAT IPO ISSUE AND REFERS TO IT LARGELY I THINK REFERRING BACK TO EVENTS BETWEEN 2006 AND 2010, ALTHOUGH THIS IS A, YOU KNOW, AN EXCHANGE THAT BEGINS IN 2010 AND THEN GOES FORWARD.

(PAUSE IN PROCEEDINGS.)

JUDGE DAVILA: MR. BOSTIC?

MR. BOSTIC: I UNDERSTAND THE DEFENSE TO BE REQUESTING THAT ANY MENTION OF AN IPO BE REDACTED FROM THIS EMAIL CONVERSATION BETWEEN MR. EISENMAN AND MS. HOLMES. I DON'T THINK THAT'S NECESSARY. I REALLY DON'T INTEND TO FEATURE THE IPO OR REPRESENTATIONS ABOUT THE IPO IN THIS WITNESS'S EXAMINATION. AS I REPRESENTED TO THE COURT BEFORE, THE GOVERNMENT IS NOT GOING TO ARGUE THAT THE DEFENDANT DEFRAUDED VICTIMS BY MAKING MISREPRESENTATIONS ABOUT AN IPO. INSTEAD, IT'S PART OF A CONVERSATION THREAD BETWEEN MS. HOLMES AND AN INVESTOR IN THERANOS WHERE THE INVESTOR IS ASKING FOR INFORMATION ABOUT WHERE THINGS STAND WITH THE COMPANY. QUESTIONS ABOUT PLANS FOR AN IPO OR TIMING OF THE IPO ARE JUST RELEVANT GENERALLY TO THAT CONVERSATION. HE'S SIMPLY ASKING FOR SOME UPDATED INFORMATION RELATING TO STATEMENTS THAT MS. HOLMES PREVIOUSLY MADE.

MR. DOWNEY: WELL, I'LL ACCEPT THAT LINE. THAT'S MORE PROGRESS THAN WHERE WE WERE, SO I'LL ACCEPT THAT, AND WE SHOULD GO FROM THERE. I APOLOGIZE FOR TAKING THIS TIME.

JUDGE DAVILA: NO, NOT AT ALL. THEY'RE IMPORTANT ISSUES. THANK YOU, MR. BOSTIC. SO I'M NOT GOING TO ORDER ANY REDACTIONS. THAT'S NOT GOING TO BE ARGUED IN YOUR CASE THEN AT ALL?

MR. BOSTIC: NO, YOUR HONOR.

MR. DOWNEY: THANK YOU, YOUR HONOR.

MR. BOSTIC: THANK YOU, YOUR HONOR.

MR. SCHENK: YOUR HONOR, MAY WE COME TO SIDE-BAR VERY BRIEFLY ABOUT A SCHEDULING ISSUE?

JUDGE DAVILA: YES. THANK YOU.

(SIDE-BAR CONFERENCE OFF THE RECORD.)

(PAUSE IN PROCEEDINGS.)

(JURY IN AT 11:30 A.M.)

JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. OUR JURY IS PRESENT. DR. DAS IS ON THE STAND. YOU'D LIKE TO RESUME YOUR EXAMINATION, MR. WADE?

MR. WADE: I WOULD, YOUR HONOR. THANK YOU.

MR. WADE: GOOD MORNING AGAIN.

KINGSHUK DAS: GOOD MORNING.

MR. WADE: BEFORE WE BROKE, I WAS ASKING YOU SOME QUESTIONS RELATING TO THE COMPANY'S RESPONSE RELATING TO ITS ANALYZER. DO YOU RECALL THAT?

MR. WADE: AND I'D LIKE TO ASK YOU ABOUT A FEW OTHER MATTERS THAT RELATE TO THE WORK THAT YOU WERE DOING WHEN YOU CAME INTO THE COMPANY FULL TIME. OKAY?

MR. WADE: COULD I DRAW YOUR ATTENTION TO EXHIBIT 10674, WHICH SHOULD BE IN YOUR BINDER.

MR. WADE: AND DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU?

MR. WADE: AND IS THIS AN EMAIL IN WHICH YOU WERE GIVING AN UPDATE TO MS. HOLMES ON THE WORK YOU WERE DOING AFTER YOU STARTED AT THE COMPANY FULL TIME?

MR. WADE: MOVE THE ADMISSION OF 10674.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10674 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: HERE YOU NOTE -- LET'S LOOK AT THE SUBJECT MATTER. IT SAYS "SOME GOOD NEWS, FOR ONCE." DO YOU SEE THAT?

MR. WADE: AND WE TALKED ABOUT THE MEETING THAT OCCURRED AND SOME OTHER COMMUNICATIONS WHERE YOU WERE AT TIMES DELIVERING WHAT COULD BE CONSIDERED BAD NEWS. DO YOU RECALL THAT?

MR. WADE: AND YOU WERE, ON THIS PARTICULAR OCCASION, ON THIS WORK, YOU ACTUALLY HAD SOME GOOD NEWS TO REPORT; RIGHT?

MR. WADE: OKAY. LET'S TAKE A LOOK. IT NOTES HERE THAT YOU HAD DONE CALCULATIONS FOR TWO OF THE FIVE CAPILLARY 1800 ANALYTES, GLUCOSE AND SODIUM, FOR THOSE VALIDATIONS. DO YOU SEE THAT?

MR. WADE: AND THEY LOOK EXCELLENT. DO YOU SEE THAT?

MR. WADE: AND YOU THEN NOTE DOWN BELOW THAT YOU WERE NOT A BIG FAN OF CERTAIN ASPECTS OF THE STUDIES AS THEY WERE DOCUMENTED; IS THAT FAIR?

KINGSHUK DAS: YES. I DON'T HAVE A SPECIFIC RECOLLECTION.

MR. WADE: OKAY. BUT YOU THOUGHT THE DATA WAS GOOD ON THESE?

KINGSHUK DAS: IT APPEARS SO.

MR. WADE: AND THE 1800 ANALYTES, THOSE WERE ADVIA 1800?

MR. WADE: AND THOSE WERE THE CIRCUMSTANCES IN WHICH THE COMPANY WAS RUNNING A SMALL SAMPLE ASSAY ON A MODIFIED ADVIA 1800. DO YOU RECALL THAT?

MR. WADE: AND DO YOU RECALL LEARNING WHEN YOU WERE THERE THAT THE ADVIA 1800, THE COMPANY HAD ADAPTED SOME TECHNOLOGY TO MODIFY THE ADVIA 1800 SO IT COULD RUN SMALL SAMPLES OF THE ASSAYS IN A HIGH THROUGHPUT MANNER?

MR. WADE: AND THAT'S WHAT YOU'RE REFERRING TO IN THIS EMAIL?

MR. WADE: OKAY. AND IN YOUR PRIOR EXPERIENCE AS A LAB DIRECTOR, HAVE YOU EVER SEEN SOMEONE DO THESE ASSAYS ON A SMALL SAMPLE IN A HIGH THROUGHPUT MANNER?

MR. WADE: YOU HAVE? ON A FINGERSTICK?

KINGSHUK DAS: I DON'T RECALL IF IT WAS A FINGERSTICK.

KINGSHUK DAS: I BELIEVE HEELSTICK.

MR. WADE: HEELSTICK. OKAY. AND THE -- IN LOOKING AT THESE VALIDATIONS, THIS WAS PART OF ONE OF THOSE ASPECTS WHERE YOU WERE JUST TURNING OVER THE DIFFERENT ROCKS AND LOOKING AT THE DIFFERENT ITEMS WITHIN THE LAB TO GET YOURSELF COMFORTABLE WITH IT; IS THAT RIGHT?

MR. WADE: AND, IN FACT, IN THE NEXT EMAIL BELOW, YOU NOTE THAT YOU'RE GOING TO LOOK AT THE THREE OTHER ANALYTES; CORRECT?

MR. WADE: AND DO YOU RECALL WHETHER YOU DID THAT?

MR. WADE: OKAY. I'D LIKE TO NEXT TURN YOUR ATTENTION TO EXHIBIT 10651, WHICH SHOULD BE A COUPLE DOCUMENTS BACK?

MR. WADE: AND IS THIS AN EMAIL COMMUNICATION BETWEEN YOU AND MS. HOLMES IN WHICH YOU'RE INFORMING HER OF PLANS THAT YOU HAD UNDERWAY TO DIG IN ON THE CMS RESPONSE?

MR. WADE: MOVE THE ADMISSION OF 10651.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10651 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: OKAY. IN THIS EMAIL IN EARLY APRIL YOU SAY, "AFTER WE GOT BACK FROM NWK." IS NWK THE NEWARK LAB?

MR. WADE: YOU GOT IN TOUCH WITH MICHELE, FRAN, AND LISA. DO YOU KNOW WHO MICHELE, FRAN, AND LISA ARE THERE?

MR. WADE: AND WHO ARE THEY?

KINGSHUK DAS: MICHELE REFERS TO MICHELE CARBONE, FRAN REFERS TO FRANCIS YOUNG, AND LISA REFERS TO LISA HELFEND, DR. HELFEND.

MR. WADE: OKAY. AND THOSE WERE SOME OF THE OUTSIDE CONSULTANTS THAT THE COMPANY BROUGHT IN TO WORK ON CMS ISSUES AND IMPROVING THE LAB?

MR. WADE: AND IT NOTES HERE IN THIS EMAIL, "WE'RE FULL STEAM AHEAD ON 2120 AND REVIEW OF THE CMS RESPONSE, AS YOU OUTLINED EARLIER TODAY." DO YOU SEE THAT?

MR. WADE: AND DOES THIS INDICATE THAT YOU PUT THIS TEAM TO WORK ON DIGGING IN AND ADDRESSING ISSUES THAT WERE COMING UP IN CMS?

MR. WADE: OKAY. AND YOU NOTE A CHANGE THERE IN THE SECOND PARAGRAPH, AND IT SAYS -- CAN YOU TELL ME WHAT YOU'RE REFERRING TO IN THIS PARAGRAPH?

KINGSHUK DAS: YES. TO THE BEST OF MY RECOLLECTION, I WAS RECOMMENDING THAT A STAFF MEMBER NAMED JUN RUN THE 2120 ASSAY INSTEAD OF ANOTHER STAFF MEMBER NAMED HODA.

MR. WADE: OKAY. AND THAT WAS BECAUSE YOU THOUGHT THAT WOULD BE A BETTER FIT?

KINGSHUK DAS: YES. HE HAD MORE EXPERIENCE.

MR. WADE: OKAY. AND YOU WANTED SOMEONE WITH THE MOST EXPERIENCE ON THAT?

MR. WADE: THEN IN THE NEXT LINE YOU SAY YOU'LL BE CONTACTING A. BACA IN A FEW MINUTES TO SECURE HIS SERVICES, IF POSSIBLE. DO YOU SEE THAT?

MR. WADE: AND IS THAT DR. BACA, THE LABORATORY CONSULTANT THAT WE REFERRED TO PREVIOUSLY?

KINGSHUK DAS: YES, DR. AUTHOR BACA.

MR. WADE: AND YOU WERE BRINGING IN EVEN MORE RESEARCHERS TO WORK ON THIS; RIGHT?

MR. WADE: AND THAT WAS BECAUSE YOU WANTED TO GO QUICKLY AND ADDRESS IT THOROUGHLY. IS THAT FAIR?

KINGSHUK DAS: I DON'T RECALL MY EXACT INTENTIONS WITH DR. BACA.

MR. WADE: OKAY. BUT GENERALLY WITH RESPECT TO WHAT YOU WERE DOING HERE, IS IT FAIR TO SAY THAT YOU WANTED TO BE THOROUGH?

MR. WADE: AND TRY TO DEAL WITH IT AS QUICKLY AS YOU COULD CONSIDERING YOUR PROFESSIONAL OBLIGATIONS?

MR. WADE: AND YOU NOTE WE'RE GOING TO GET ALL OF THIS DONE, AND THIS IS JUST AN UPDATE; RIGHT?

MR. WADE: AND MS. HOLMES IS NOT DIRECTLY INVOLVED IN THE WORK THAT YOU WERE DOING; RIGHT?

KINGSHUK DAS: NOT TO MY RECOLLECTION.

MR. WADE: BUT YOU WERE REPORTING TO HER AT THIS TIME?

MR. WADE: AND YOU WERE GIVING HER AN UPDATE ON YOUR PLAN; RIGHT?

MR. WADE: OKAY. LET'S LOOK AT HER RESPONSE. SHE THANKS YOU FOR THE UPDATE AND FOR DRIVING THIS FORWARD AND NOTES THIS IS HOW WE MAKE SURE WE GET ACCEPTED BY CMS. DO YOU SEE THAT?

MR. WADE: AND DID YOU FEEL LIKE IN THIS TIME PERIOD MS. HOLMES WAS DEDICATED TO GIVING YOU WHATEVER RESOURCES YOU ASKED FOR TO TRY TO ADDRESS THESE LAB ISSUES?

MR. WADE: AND DID YOU FEEL LIKE SHE WAS GIVING YOU UNFETTERED ACCESS TO THE INFORMATION THAT YOU NEEDED WITHIN THE COMPANY TO DO A THOROUGH ANALYSIS?

KINGSHUK DAS: COULD YOU SPECIFY, PLEASE?

MR. WADE: WELL, WHEN YOU WERE TURNING OVER THOSE ROCKS, DO YOU RECALL TALKING ABOUT THAT?

MR. WADE: DID YOU FEEL LIKE YOU COULD LOOK AT ANY INFORMATION OR DATA THAT YOU NEEDED?

KINGSHUK DAS: AS OF THE DATE OF THIS EMAIL, I DON'T RECALL. AS TIME WENT ON, YES.

MR. WADE: AND SO AS TIME WENT ON, YOU WOULD GET MORE AND MORE INFORMATION; RIGHT?

MR. WADE: OKAY. LET'S LOOK NEXT AT 10641.

MR. WADE: AND THIS -- DO YOU RECOGNIZE THIS TO BE AN EMAIL COMMUNICATION BETWEEN YOU AND MS. HOLMES IN EARLY MARCH OF 2016 RELATING TO SOME OF THERANOS'S TECHNOLOGY?

MR. WADE: MOVE THE ADMISSION OF 10641.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10641 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND I JUST WANT TO FOCUS ON A COUPLE OF THINGS. YOU RECALL THAT A LOT OF THE QUESTIONING RELATED TO THE OLDER 3.0 DEVICE. DO YOU RECALL THAT QUESTIONING?

MR. WADE: BUT WE TALKED ABOUT THE NEWER DEVICE THAT THE COMPANY WAS BRINGER FORWARD?

MR. WADE: AND DO YOU RECALL HAVING A MEETING IN MARCH WHERE YOU WERE SHOWN THAT DEVICE AND GIVEN A SENSE FOR HOW IT WAS DEVELOPED, BEING DEVELOPED?

KINGSHUK DAS: I DON'T RECALL THAT SPECIFIC MEETING.

MR. WADE: DOES THIS EMAIL REFRESH YOUR RECOLLECTION OF A MEETING THAT YOU HAD, A SCIENTIFIC MEETING?

KINGSHUK DAS: IT DOES NOT, BUT I DON'T DOUBT IT.

MR. WADE: OKAY. YOU SEE THERE IN THE SECOND PARAGRAPH IT SAYS, "NOW THAT I'VE SEEN 'UNDER THE HOOD' OF YOUR INSTRUMENT, SOMETHING ALONG THESE LINES WOULD BE PERFECT AS FAR AS SPACE, PLUS ONLY NEEDS A LAPTOP PROCESSOR." DO YOU SEE THAT?

MR. WADE: AND DO YOU RECALL THAT THERE WAS -- MAYBE YOU DON'T REMEMBER THIS MEETING, BUT DO YOU RECALL SOME POINT IN TIME WHERE YOU GOT A LOOK UNDER THE HOOD OF THE THERANOS INSTRUMENT?

MR. WADE: AND THAT WAS THE NEXT GENERATION INSTRUMENT AFTER THE 3.5?

KINGSHUK DAS: YES. I DON'T REMEMBER WHICH GENERATION EXACTLY, BUT YES.

MR. WADE: OKAY. AND YOU HAD A PARTICULAR -- YOU HAD SOME PARTICULAR BACKGROUNDS ON SOME RNA, RRNA SEQUENCING BASED UPON SOME WORK THAT YOU HAD DONE AT UCLA; IS THAT RIGHT?

MR. WADE: AND YOU WERE SUGGESTING SOME WAYS IN WHICH THE DEVICE MIGHT BE ABLE TO ADAPT TO INCLUDE SOME OF THAT TECHNOLOGY?

MR. WADE: AND YOU UNDERSTOOD THAT THE PRODUCT THAT WAS BEING DEVELOPED WAS BEING DEVELOPED SO IT COULD RUN MULTIPLE DIFFERENT TYPES OF ASSAYS ON A SINGLE DEVICE?

MR. WADE: AND WERE YOU AWARE OF THAT EVER BEING DONE BEFORE?

KINGSHUK DAS: NOT TO MY RECOLLECTION.

MR. WADE: OKAY. AND SO YOU WERE MAKING SOME RECOMMENDATIONS BASED UPON YOUR EXPERIENCE FOR WAYS IN WHICH THAT MIGHT BE MODIFIED TO ACCOUNT FOR SOME ADDITIONAL AREAS OF TESTING?

MR. WADE: OKAY. AND LET ME ASK YOU -- YOU DON'T RECALL THE SPECIFIC DEVICE, BUT LET ME ASK YOU AND SHOW YOU A PICTURE AND SEE IF THIS IS THE DEVICE. I'LL HAND UP TWO PICTURES. MAY I APPROACH, YOUR HONOR?

BY MR. WADE:

MR. WADE: (HANDING.) DR. DAS, I'VE HANDED YOU TWO DOCUMENTS, ONE MARKED EXHIBIT 7747 AND ANOTHER MARKED 7746. DO YOU RECOGNIZE THIS TO BE THE DEVICE THAT YOU WERE SHOWN -- A DEVICE OF THIS TYPE BEING THE ONE THAT YOU WERE SHOWN WHEN YOU JOINED THE COMPANY?

KINGSHUK DAS: I RECOGNIZE THIS DEVICE. I DON'T KNOW IF THIS IS THE DEVICE WE'RE REFERRING TO IN THE EMAIL.

MR. WADE: OKAY. YOU DON'T KNOW IF IT'S THE DEVICE THAT YOU ARE REFERRING TO IN EXHIBIT 10641?

KINGSHUK DAS: THAT'S CORRECT.

MR. WADE: OKAY. BUT YOU WERE SHOWN THIS DEVICE AT SOME POINT?

MR. WADE: AND THIS IS WHAT -- THIS DEVICE IS SOMETIMES WHAT IS REFERRED TO AS THE MINILAB?

MR. WADE: OKAY. MOVE TO ADMIT EXHIBIT 7747 AND 7746.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: THEY'RE ADMITTED AND MAY BE PUBLISHED.

(DEFENDANT'S EXHIBITS 7746 AND 7747 WERE RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND THIS IS A COPY OF THAT DEVICE WHICH IS SHOWING UP IN BLACK AND WHITE ON THE SCREEN. AND YOU SAW THIS DEVICE WHEN YOU WERE WORKING WITH THE COMPANY?

MR. WADE: AND YOU UNDERSTOOD THAT IN THE SLOT THERE ON THE FRONT BELOW THE LABEL THERANOS IS WHERE A CARTRIDGE WOULD GO IN?

MR. WADE: OKAY. AND COULD WE PUBLISH 7746, PLEASE. AND IS THIS SORT OF UNDER THE HOOD, IF YOU WILL, OF THAT DEVICE?

MR. WADE: AND THE IDEA WAS THAT DIFFERENT FORMS OF SENSORS AND THE LIKE COULD BE ADAPTED ONTO THIS PLATFORM SO THAT DIFFERENT TYPES OF ASSAYS COULD BE RUN; IS THAT RIGHT?

MR. WADE: OKAY. AND IN THIS EMAIL IN MARCH, YOU'RE PROVIDE SOME THOUGHTS AND INPUT TO MS. HOLMES IN THAT REGARD; IS THAT RIGHT?

MR. WADE: I BELIEVE YOU TESTIFIED ON DIRECT ABOUT PARTICIPATING IN A MEETING WITH DR. GOODRICH FROM CMS. DO YOU RECALL THAT?

MR. WADE: AND THAT WAS A MEETING -- AND DO YOU RECALL WHO DR. GOODRICH IS?

MR. WADE: AND WHO WAS DR. GOODRICH?

KINGSHUK DAS: I BELIEVE HER TITLE WAS MEDICAL DIRECTOR AT CMS FOR LABORATORIES.

KINGSHUK DAS: BUT I DON'T KNOW THE EXACT WORDING.

MR. WADE: SHE WAS A SENIOR POSITION OR SENIOR PERSON WITHIN CMS; IS THAT RIGHT?

MR. WADE: AND THERE WAS -- DO YOU RECALL THAT THERANOS PROVIDED A WRITTEN BRIEFING ON THE STEPS THAT THEY WERE TAKING UNDER YOUR LEADERSHIP TO IMPROVE THE QUALITY OF THE LAB?

MR. WADE: AND THERE WAS A MEETING OUT IN BALTIMORE, MARYLAND TO DISCUSS THAT. DO YOU RECALL THAT?

MR. WADE: AND YOU PARTICIPATED IN THAT, ALONG WITH OTHER PEOPLE AT THERANOS WHO PROVIDED INFORMATION TO DR. GOODRICH; IS THAT RIGHT?

MR. WADE: AND I TAKE IT YOU FELT AT THE TIME THAT THE COMPANY HAD MADE A LOT OF PROGRESS IN IMPROVING THE LAB AND WAS COMMITTED TO EVEN MAKING MORE. IS THAT FAIR?

MR. WADE: OKAY. A SIGNIFICANT FOCUS OF THAT WAS ACTUALLY BRINGING YOU IN AS LABORATORY DIRECTOR; RIGHT?

MR. WADE: YOU WERE CONSIDERED BY THE COMPANY TO BE HIGHLY QUALIFIED AND CREDENTIALED AND CAPABLE OF DOING THIS VERY IMPORTANT JOB; RIGHT?

KINGSHUK DAS: I CAN'T SPEAK TO THEIR THOUGHTS EXACTLY.

MR. WADE: WELL, DO YOU RECALL THEM ARTICULATING THAT TO CMS?

MR. WADE: AND THERE WAS ALSO A SUBSTANTIAL REWORKING OF THE PERSONNEL WITHIN THE LAB AT THERANOS; RIGHT?

MR. WADE: AND THAT WAS FEATURED AS PART OF THAT RESPONSE AS WELL; RIGHT?

KINGSHUK DAS: YES, I BELIEVE SO.

MR. WADE: AND THERE WAS ALSO ENHANCED POLICIES AND PROCEDURES THAT WERE PUT IN PLACE?

MR. WADE: AND THERE WAS NEW COMPREHENSIVE TRAINING THAT WAS IMPLEMENTED TO ENSURE THAT PEOPLE UNDERSTOOD WHAT THEY WERE DOING?

MR. WADE: AND UNDERSTOOD THEIR JOBS AND HOW THE LAB TECHNOLOGY WORKED; RIGHT?

MR. WADE: THERE WAS -- WE TALKED ABOUT THERE WAS A NEW OPERATIONAL STRUCTURE WHERE YOU REPORTED DIRECTLY TO THE CEO; CORRECT?

MR. WADE: AND THE COMPANY ALSO IMPLEMENTED SOME ENHANCED AUDIT PROCEDURES. DO YOU RECALL THAT?

MR. WADE: AND THEY ALSO IMPLEMENTED A NEW QUALITY MONITORING AND PROCESSING PROGRAM. DO YOU RECALL THAT?

MR. WADE: AND ALL OF THESE THINGS ARE UNDER YOUR LEADERSHIP; IS THAT RIGHT?

MR. WADE: AND THEY WERE WITH THE SUPPORT OF MS. HOLMES; CORRECT?

MR. WADE: DO YOU RECALL THERE WAS ALSO SOME EFFORTS MADE TO DO WHAT ARE CALLED TRACER AUDITS?

MR. WADE: AND WHAT IS A TRACER AUDIT?

KINGSHUK DAS: BASICALLY IT IS A PERIODIC AUDITING BACK OF A SAMPLE ALL OF THE WAY THROUGH THE LABORATORY PROCESS TO MAKE SURE ALL OF THE PROCEDURES WERE FOLLOWED.

MR. WADE: OKAY. SO YOU FOLLOW IT THROUGH FROM CRADLE TO GRAVE, IF YOU WILL?

KINGSHUK DAS: YES, AND VICE VERSA.

MR. WADE: AND MAKE SURE THAT ALL OF THE DIFFERENT STEPS IN THE PROCESS ARE WORKING?

MR. WADE: OKAY. AND WAS THAT SOMETHING THAT YOU IMPLEMENTED AT THERANOS?

MR. WADE: OKAY. AND, OF COURSE, YOU ALSO WORKED TO TRY TO GET THOSE CORRECTED LABORATORY REPORTS OUT AS WELL. DO YOU RECALL THAT?

MR. WADE: AND THAT WAS PART OF WHAT YOU WORKED ON AT THERANOS; RIGHT?

MR. WADE: OKAY. AND DO YOU -- ONE OF THE THINGS, WE TALKED A LITTLE BIT ABOUT HOW YOU WERE LOOKING AT SOME OF THE ADVIA 1800 ASSAYS. DO YOU RECALL THAT?

MR. WADE: AND DO YOU RECALL COMING TO THE CONCLUSION WITH RESPECT TO GETTING YOURSELF COMFORTABLE WITH RESPECT TO SOME OF THOSE ASSAYS AND THEIR VALIDATION AND COMMUNICATING THAT TO CMS?

MR. WADE: AND SPECIFICALLY RELATING TO AN ASSAY ALT?

MR. WADE: AND WHAT IS THAT?

KINGSHUK DAS: THAT STANDS FOR ALANINE AMINOTRANSFERASE.

MR. WADE: I'M GLAD YOU SAID THAT AND NOT ME. AND HOW ABOUT BUN?

MR. WADE: AND WHAT IS THAT?

KINGSHUK DAS: THAT STANDS FOR BLOOD UREA NITROGEN.

MR. WADE: OKAY. AND IN ADDITION TO THAT, ALSO CALCIUM, GLUCOSE, AND SODIUM; IS THAT RIGHT?

MR. WADE: AND YOUR ANALYSIS GAVE YOU COMFORT IN CONNECTION WITH THOSE ASSAYS; CORRECT?

KINGSHUK DAS: YES, AT THAT POINT IN TIME.

MR. WADE: LET ME DRAW YOUR ATTENTION TO 10629. AND DO YOU RECALL -- I THINK YOU TALKED ABOUT THE COMPANY WAS RECEIVING IN THIS TIME PERIOD A FAIR AMOUNT OF MEDIA SCRUTINY. DO YOU RECALL THAT?

MR. WADE: AND FROM TIME TO TIME, THE COMPANY WOULD BE ASKED TO MAKE STATEMENTS TO MEDIA OUTLETS. DO YOU RECALL THAT?

MR. WADE: AND IN CONNECTION WITH THAT, YOU WOULD SOMETIMES BE ASKED TO REVIEW A COMMENT. DO YOU RECALL THAT?

MR. WADE: AND IS 10629 ONE OF THOSE OCCASIONS WHERE YOU WERE ASKED TO REVIEW A COMMENT?

MR. WADE: OKAY. MOVE TO ADMIT 10629.

MR. LEACH: HEARSAY, YOUR HONOR.

JUDGE DAVILA: ARE YOU OFFERING IT FOR THE TRUTH OF WHAT WAS SAID IN THE STATEMENT?

MR. WADE: NO, I AM NOT.

JUDGE DAVILA: WHAT IS THE RELEVANCE?

MR. WADE: THE RELEVANCE IS THAT THERE WAS A STATEMENT THAT THE COMPANY WAS INTENDING TO MAKE AND THE WITNESS WAS ASKED TO REVIEW IT, AND SO IT INFORMED MS. HOLMES'S STATE OF MIND AS TO THE ACCURACY OF THE STATEMENT.

JUDGE DAVILA: CAN YOU LAY A FOUNDATION FOR THAT?

MR. WADE: SURE. WHY DON'T I GO A DIFFERENT DIRECTION HERE?

MR. WADE: I TAKE IT THE OBJECTION IS IN CONNECTION WITH THE TOP EMAIL?

JUDGE DAVILA: WELL, I THINK IT'S THE ENTIRETY OF THE DOCUMENT, IS IT, MR. LEACH?

MR. LEACH: YES, YOUR HONOR.

MR. WADE: OKAY. LET'S TAKE A LOOK AT 10628.

MR. WADE: WE TALKED ABOUT HOW THE COMPANY IN THIS PERIOD WAS BEING ASKED TO PROVIDE MEDIA COMMENTS ON, MEDIA STATEMENTS IN CONNECTION WITH ISSUES THAT WERE ARISING. DO YOU RECALL THAT?

MR. WADE: AND THERE WAS A TEAM OF PEOPLE WHO WORKED ON INTERACTING WITH THE MEDIA IN THAT PERIOD; CORRECT?

MR. WADE: AND BEFORE THE COMPANY WOULD ISSUE STATEMENTS RELATING TO YOUR AREA, THEY WOULD OFTENTIMES GO THROUGH A PROCESS WHERE THEY WOULD RUN IT BY YOU TO MAKE SURE THAT YOU WERE COMFORTABLE WITH THE LANGUAGE THAT WAS BEING OFFERED; RIGHT?

KINGSHUK DAS: YES. THAT WAS NOT ALWAYS DONE, BUT FROM TIME TO TIME.

MR. WADE: RIGHT. AND THAT WAS, IN PART, TO ENSURE THAT, BASED UPON YOUR AREA OF EXPERTISE, THAT YOU WERE COMFORTABLE THAT THE STATEMENT WAS AN ACCURATE REPRESENTATION; CORRECT?

KINGSHUK DAS: I DON'T KNOW IF I COULD SPEAK TO THEIR INTENTIONS.

MR. WADE: OKAY. BUT YOU -- DID YOU UNDERSTAND THAT THEY WERE ASKING FOR YOU TO CHECK THE ACCURACY OF THE STATEMENT WHEN IT WAS SENT TO YOU?

MR. WADE: AND THE WAY IN WHICH THEY WOULD COMMUNICATE THAT TO YOU WAS VIA EMAIL SOMETIMES?

MR. WADE: AND THAT WAS OFTENTIMES THE WAY IN WHICH THE COMPANY WOULD GO ABOUT DOING BUSINESS ON VARIOUS MATTERS; IS THAT RIGHT?

MR. WADE: AND INCLUDING ON THESE TYPES OF ISSUES; RIGHT?

MR. WADE: AND YOU UNDERSTOOD THAT IT WAS IMPORTANT WHEN YOU WERE DOING THIS TO TRY AND PROVIDE ACCURATE INFORMATION IN RESPONSE TO ANY INQUIRIES THAT WERE MADE OF YOU; RIGHT?

MR. WADE: AND YOU UNDERSTOOD THAT THE COMPANY HAD A PROCESS WHEREBY THEY WERE PRESERVING ITS ELECTRONIC INFORMATION; RIGHT?

KINGSHUK DAS: I DON'T KNOW IF I KNEW THAT AT THE TIME.

MR. WADE: OKAY. BUT YOU UNDERSTOOD THAT THE EMAILS WERE PART OF THE BOOKS AND RECORDS OF THE COMPANY?

MR. WADE: AND THAT THEY WERE PART OF THE WAY IN WHICH THE COMPANY OPERATED FROM A BUSINESS ON A VARIETY OF DIFFERENT ISSUES?

MR. WADE: OFFER 10628.

MR. LEACH: NO OBJECTION TO 10628, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10628 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: OKAY. AND IF YOU LOOK ON THE BOTTOM, DO YOU SEE MR. BALWANI WAS SENDING YOU A STATEMENT THAT WAS MADE AND ASKING YOU TO REVIEW IT AND MAKE SURE THAT IT WAS REASONABLE. DO YOU SEE THAT?

MR. WADE: AND ON OTHER OCCASIONS MS. HOLMES ASKED YOU TO PERFORM EXACTLY THE SAME KIND OF REVIEW; IS THAT RIGHT?

MR. WADE: AND YOU UNDERSTOOD THAT WHEN SHE DID THAT, IT WAS TO GET YOUR VIEW AS TO WHETHER OR NOT THE STATEMENT WAS ACCURATE; RIGHT?

MR. WADE: OKAY. AND LET'S JUST LOOK AT THE STATEMENT THAT IS PROVIDED HERE. THIS SAYS, "CMS SURVEYS EVALUATE LAB PRACTICES. THE DEFICIENCIES CITED REFER TO HOW CERTAIN THERANOS TECHNOLOGIES WERE USED AND NOT TO THE FUNDAMENTAL INTEGRITY OF THE TECHNOLOGIES THEMSELVES. THE COMPANY'S PROPRIETARY TECHNOLOGIES HAVE ALWAYS BEEN CLEARED FOR TESTING HSV-1 BY THE FDA. SEPARATELY, THE MAJORITY OF THE CMS DEFICIENCIES WERE NOT RELATED TO THERANOS PROPRIETARY TECHNOLOGIES." DO YOU SEE THAT?

MR. WADE: IF WE JUST LOOK AT YOUR RESPONSE. YOU BELIEVED AT THE TIME THAT IT WAS A TRUE AND ACCURATE STATEMENT; IS THAT CORRECT?

KINGSHUK DAS: THAT'S CORRECT.

MR. WADE: AND AGAIN, ON OTHER OCCASIONS MS. HOLMES ASKED YOU TO PERFORM EXACTLY THAT KIND OF REVIEW; RIGHT?

KINGSHUK DAS: I DON'T RECALL THE SPECIFIC OCCASIONS.

MR. WADE: OKAY. WELL, LET'S LOOK AT 10629.

MR. WADE: DOES THIS REFRESH YOUR RECOLLECTION OF MS. HOLMES ASKING YOU TO PERFORM A REVIEW OF A STATEMENT THAT WAS GOING TO BE PROVIDED TO MAKE SURE THAT IT WAS ACCURATE?

MR. WADE: AND THIS IS IN THE -- YOU RECALL HER DOING THAT IN LATE MARCH OF 2016?

KINGSHUK DAS: YES, IT APPEARS SO.

MR. WADE: OKAY. I'D LIKE TO TALK A LITTLE MORE ABOUT SOME OTHER REFORMS THAT YOU WERE WORKING ON WITHIN THE LAB DURING YOUR TENURE AT THERANOS. IF WE CAN GO TO 13333. THAT'S ONE 1, FOUR 3'S.

MR. WADE: DO YOU RECALL THAT THERE WERE SOME ISSUES THAT AROSE IN CONNECTION WITH -- OR ISSUES THAT YOU DISCOVERED IN CONNECTION WITH REVIEWING THE WORK OF THE BUGS LAB?

MR. WADE: AND FOR THE BENEFIT OF THE JURY, WHAT IS THE BUGS LAB?

KINGSHUK DAS: IT WAS OUR CODE NAME FOR THE MICROBIOLOGY LAB IN NEWARK.

MR. WADE: OKAY. AND JUST GIVE US A SENSE OF WHAT THE MICROBIOLOGY LAB WAS AND HOW IT DIFFERED FROM OTHER LABS.

KINGSHUK DAS: IT DIFFERED BY THE TYPE OF TESTING. SO THIS TYPE OF LABORATORY IS INVOLVED IN IDENTIFYING INFECTIOUS ORGANISMS.

MR. WADE: OKAY. AND DOES THIS EMAIL RELATE TO, DOES THIS EMAIL RELATE TO CONCERNS THAT YOU DISCOVERED OR ISSUES YOU DISCOVERED IN CONNECTION WITH YOUR WORK AS LAB DIRECTOR?

MR. WADE: MOVE THE ADMISSION OF 13333.

MR. LEACH: YOUR HONOR, I DON'T OBJECT TO THE BOTTOM PORTION OF THE EMAIL. THE TOP PORTION IS HEARSAY.

(PAUSE IN PROCEEDINGS.)

MR. WADE: I OFFER IT FOR THE STATE OF MIND OF MS. HOLMES, NOT FOR THE TRUTH.

JUDGE DAVILA: AS TO WHAT ISSUE? AS TO WHAT ISSUE?

MR. WADE: AS TO THE REMEDIAL EFFORTS THAT WERE BEING MADE WITHIN THE LAB.

MR. LEACH: IT'S AN OUT-OF-COURT STATEMENT BY A NONTESTIFYING WITNESS, YOUR HONOR. IT WAS THE SUBJECT OF A MOTION IN LIMINE.

JUDGE DAVILA: DO YOU HAVE ANY OBJECTION TO IT COMING IN SOLELY FOR THE STATE OF MIND FOR REMEDIAL ISSUES AT THIS TIME?

JUDGE DAVILA: ALL RIGHT. I'M GOING TO SUSTAIN THE OBJECTION.

MR. WADE: OKAY. I'M GOING TO OFFER -- I CAN REDACT THAT EMAIL.

MR. WADE: COULD I OFFER THE BOTTOM PORTION OF THE DOCUMENT?

JUDGE DAVILA: I THINK YOU CAN DO THAT, YES.

(DISCUSSION OFF THE RECORD WITH THE COURT AND CLERK.)

MR. WADE: MAY I PUBLISH?

(DEFENDANT'S EXHIBIT 13333, REDACTED, WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: THIS EMAIL RELATES TO THE ISSUE WE WERE JUST DISCUSSING; IS THAT CORRECT?

MR. WADE: AND IN THIS YOU NOTE SOME GOOD NEWS LAST NIGHT REGARDING THE CAPILLARY DATA. DO YOU SEE THAT?

MR. WADE: AND LET'S FOCUS ON THE BOTTOM EMAIL. DO YOU SEE THAT THIS IS WHAT REFERS TO THE BUGS LAB?

MR. WADE: IT SAYS -- YOU IDENTIFIED SOME CONCERNS WITHIN THAT LAB THAT MAY JEOPARDIZE PATIENT CARE, "SO I'M BRINGING THAT ASSAY DOWN." AND IS THAT ASSAY REFERRING TO HIV?

MR. WADE: OKAY. AND THEN YOU NOTED, "AS WELL AS ALL OTHERS IN THE BUGS LAB." CORRECT?

MR. WADE: "AS THERE'S NO REASON TO GO ASSAY BY ASSAY IN OUR LOOK BACK AFTER UNCOVERING SUCH ISSUES." RIGHT?

MR. WADE: AND IS THAT FAIR TO SAY, THAT YOU WERE EFFECTIVELY SHUTTING DOWN THE BUGS LAB?

MR. WADE: AND THAT'S BECAUSE, AS YOU WERE TURNING OVER THOSE ROCKS, YOU CAME TO THE VIEW THAT THAT'S WHAT NEEDED TO BE DONE HERE; RIGHT?

MR. WADE: AND WAS MS. HOLMES FULLY SUPPORTIVE OF YOUR DECISION TO DO THAT?

MR. WADE: WAS TURNING OVER THOSE ROCKS AND FINDING THOSE ISSUES EXACTLY WHAT SHE WANTED YOU TO DO WHEN SHE HIRED YOU?

MR. LEACH: OBJECTION. FOUNDATION.

BY MR. WADE:

MR. WADE: DID YOU UNDERSTAND --

JUDGE DAVILA: THIS IS A NEW QUESTION?

MR. WADE: YEAH. I'LL WITHDRAW THE QUESTION.

MR. WADE: DID YOU UNDERSTAND THAT THIS WAS EXACTLY THE KIND OF WORK AND DISCOVERY THAT MS. HOLMES WAS ASKING YOU TO DO?

MR. WADE: OKAY. LET'S GO TO 10668.

MR. WADE: AND DO YOU RECALL EARLIER WE TALKED ABOUT EFFORTS THAT YOU WERE MAKING TO ENSURE THAT LABORATORY PERSONNEL WERE QUALIFIED AND UP TO THE JOB?

MR. WADE: AND THAT WAS SOMETHING THAT WAS IMPORTANT TO YOU?

MR. WADE: AND IS THIS EMAIL CHAIN AN EMAIL IN WHICH YOU WERE COMMUNICATING WITH A TEAM AT THERANOS ABOUT MAKING THOSE ASSESSMENTS AND TAKING NECESSARY ACTIONS?

MR. WADE: OFFER 10668.

MR. LEACH: HEARSAY, YOUR HONOR, TO THE BOTTOM PORTION OF PAGE 1.

JUDGE DAVILA: SHOULD THAT BE REDACTED?

JUDGE DAVILA: THE OBJECTION IS SUSTAINED. THAT CAN BE REDACTED. WHILE THAT BEING DONE, JUST GIVE ME JUST A SECOND. THE CSO HAS TO SPEAK SOMEONE IN THE AUDIENCE, THE GENTLEMAN WITH THE PLAID SHIRT. THE CSO IS GOING TO SPEAK WITH THIS GENTLEMAN FOR JUST A MOMENT.

MR. WADE: I'LL GET SOME WATER, YOUR HONOR.

(PAUSE IN PROCEEDINGS.)

JUDGE DAVILA: ALL RIGHT. THANK YOU.

MR. WADE: YOUR HONOR, JUST FOR THE RECORD, I BELIEVE THE PRIOR EXHIBIT, I JUST WANT TO MAKE SURE THE RECORD IS CLEAR, I WAS MOVING ITS ADMISSION CONTINGENT UPON THE REDACTION.

MR. WADE: I UNDERSTOOD IT WAS ADMITTED.

JUDGE DAVILA: AND WE PAUSED FOR A MINUTE TO ALLOW FOR THE REDACTIONS, AND IF IT'S ACCOMPLISHED IT CAN NOW BE PUBLISHED.

MR. WADE: AND SIMILARLY FOR THE PRIOR DOCUMENT.

MR. WADE: AND SIMILARLY FOR 10668, I WILL OFFER IT WITH THE BOTTOM PORTION TO WHICH MR. LEACH OBJECTED REDACTED. FOR THE TIME BEING I WON'T PUBLISH IT TO THE JURY.

JUDGE DAVILA: OKAY. THAT'S FINE. THANK YOU.

(DEFENDANT'S EXHIBIT 10668, REDACTED, WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: BEFORE I PUBLISH THAT DOCUMENT, I MEANT TO ASK YOU ONE MORE QUESTION ABOUT THE HIV TEST IN THE BUGS LAB.

MR. WADE: THAT WAS AN FDA APPROVED TEST THAT YOU WERE LOOKING AT; CORRECT?

MR. WADE: AND THAT WASN'T A THERANOS TECHNOLOGY ISSUE; RIGHT?

MR. WADE: AND SIMILARLY, YOU'VE BEEN ASKED SOME QUESTIONS IN DIRECT EXAMINATION ABOUT PT INR. DO YOU RECALL THAT?

MR. WADE: AND THAT WAS AN ISSUE THAT CAME UP WITH CMS; CORRECT?

MR. WADE: AND THAT WAS AN FDA APPROVED DEVICE; CORRECT?

MR. WADE: AND THAT -- BY THAT I MEAN THE ASSAY THAT HAD ISSUES THAT AROSE WAS BEING RUN ON AN FDA APPROVED DEVICE?

MR. WADE: OKAY. THAT WAS NOT THERANOS TECHNOLOGY; CORRECT?

MR. WADE: OKAY. TURNING BACK TO 10668, WHICH WE WILL PUBLISH IN REDACTED FORM, IF WE CAN GO TO THE LAST EMAIL. AND THIS IS AN EMAIL FROM TRACY MASSON IN APRIL OF 2016. DO YOU SEE THAT?

MR. WADE: DO YOU RECALL THAT TRACY MASSON WAS SORT OF A MANAGEMENT PERSON WHO WAS BROUGHT IN TO HELP IMPROVE OPERATIONS WITHIN THE LAB?

MR. WADE: SHE WASN'T A SPECIFIC TECHNICAL LAB PERSON; CORRECT?

KINGSHUK DAS: THAT'S CORRECT.

MR. WADE: SHE WAS MORE OF AN OPERATIONS OR MANAGEMENT PERSON WHO WAS HELPING OUT?

MR. WADE: AND DID YOU CONSIDER HER TO BE A GOOD EMPLOYEE AND COMPETENT?

MR. WADE: AND AS PART OF THAT EFFORT, SHE WAS WORKING WITH YOU AND OTHERS TO TRY TO MAKE SURE THAT THE RIGHT TEAM WAS IN PLACE; IS THAT RIGHT?

MR. WADE: AND THIS EMAIL TALKS ABOUT, THIS EMAIL TALKS ABOUT HOW THERE HAVE BEEN SOME ASSESSMENTS OF EMPLOYEES AND SOME RECOMMENDATIONS AS TO WHO SHOULD BE KEPT AND WHO SHOULDN'T BE KEPT; RIGHT?

MR. WADE: AND WHETHER THEY WERE A BENEFIT TO THE DEPARTMENT OR NOT A BENEFIT TO THE DEPARTMENT?

MR. WADE: OKAY. I'M NOT GOING TO PUBLISH THAT PART OF THE EXHIBIT FOR CONFIDENTIALITY REASONS, BUT I WANT TO FOCUS ON YOUR RESPONSE UP THE CHAIN. YOU THANK HER FOR THIS WORK AND YOU NOTE THAT YOU TRUST THE INPUT OF JEN. AND JEN THERE IS JEN TRICK?

MR. WADE: AND WHO IS JEN TRICK?

KINGSHUK DAS: JEN TRICK WAS ONE OF THE LABORATORY MANAGERS.

MR. WADE: OKAY. AND WAS SHE SOMEONE NEW WHO WAS BROUGHT IN AS WELL?

KINGSHUK DAS: AS OF APRIL 2016? I DON'T RECALL THE EXACT TIMELINES.

MR. WADE: OKAY. BUT WAS SHE SOMEONE WHO WAS BROUGHT IN AS PART OF THE EFFORT TO BRING NEW PERSONNEL IN AND IMPROVE THE LAB?

MR. WADE: OKAY. AND YOU THOUGHT HER TO BE A -- YOU RESPECTED HER OPINION?

MR. WADE: OKAY. AND I WANT TO FOCUS ON THE NEXT EMAIL UP THE CHAIN. I WANT TO ASK, BEFORE WE PUBLISH THAT, IF THE COURT OR COUNSEL HAS A PREFERENCE AS TO WHETHER I REDACT -- MAY I CONFER WITH MR. LEACH?

JUDGE DAVILA: YES. GO RIGHT AHEAD. PLEASE.

(DISCUSSION AMONGST GOVERNMENT AND DEFENSE COUNSEL OFF THE RECORD.)

MR. WADE: THANK YOU, YOUR HONOR. WE'RE JUST GOING TO TAKE A MOMENT AND REDACT, HAVING CONFERRED WITH COUNSEL, THE NAME OF AN INDIVIDUAL FOR CONFIDENTIALITY PURPOSES. OKAY. WE HAVE THE REDACTED DOCUMENT UP, WHICH I MOVE THE ADMISSION OF THIS REDACTED VERSION.

COURT CLERK: WHAT IS THE EXHIBIT NUMBER?

JUDGE DAVILA: THE OBJECTION, MR. LEACH? THERE'S NO OBJECTION TO THIS.

MR. LEACH: NO OBJECTION.

MR. WADE: MOVE THE ADMISSION OF 10668 AS REDACTED.

JUDGE DAVILA: AS REDACTED, IT'S ADMITTED, AND IT MAY BE PUBLISHED, YES.

(DEFENDANT'S EXHIBIT 10668, REDACTED, WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND DO YOU SEE HERE YOU'RE PROVIDING AN UPDATE ON SOME OF THESE EFFORTS THAT YOU'RE DOING WITH MS. MASSON ON -- BOTH IN THE BUGS LAB AND WITH RESPECT TO PERSONNEL?

MR. WADE: YOU NOTE FIRST THAT, WITH RESPECT TO THE BUGS LAB, THAT THERE'S A CULTURE OVER THERE THAT NEEDS CHANGING. DO YOU SEE THAT?

MR. WADE: AND YOU TALK ABOUT SOME WAYS IN WHICH YOU'RE GOING TO GO ABOUT TRYING TO DO THAT; RIGHT?

MR. WADE: AND THEN LET'S FOCUS ON THE NEXT PARAGRAPH. AND THERE IT SAYS WITH RESPECT TO A CERTAIN INDIVIDUAL, YOU HAD MORE SIGNIFICANT CONCERNS, DIDN'T YOU?

MR. WADE: YOU HAD CONCERNS ABOUT INCOMPETENCE AND DISHONESTY; RIGHT?

MR. WADE: AND YOU WERE UNWILLING TO TOLERATE THAT; IS THAT RIGHT?

MR. WADE: AND SO YOU --

KINGSHUK DAS: THE DISHONESTY PART.

MR. WADE: RIGHT. THE DISHONESTY WAS -- INCOMPETENCE MAYBE YOU COULD WORK AND TRAIN TO IMPROVE THE PERSON; IS THAT FAIR?

MR. WADE: BUT SOMEONE WHO WAS DISHONEST YOU HAD NO PATIENCE FOR; IS THAT RIGHT?

MR. WADE: AND AS A RESULT OF THAT, YOU ASKED TO HAVE THAT PERSON REMOVED; IS THAT CORRECT?

MR. WADE: AND THAT PERSON WAS REMOVED; CORRECT?

MR. WADE: AND MS. HOLMES WAS FULLY SUPPORTIVE OF THOSE EFFORTS; RIGHT?

MR. WADE: AND SHE KNEW IT WAS IMPORTANT THAT YOU HAD THE TEAM THAT YOU FELT LIKE YOU NEEDED?

MR. WADE: AND YOU UNDERSTOOD THAT SHE WASN'T GOING TO TOLERATE ANY INTEGRITY ISSUES EITHER; CORRECT?

MR. WADE: AND LET'S GO TO THE TOP EMAIL ON PAGE 1. AND YOU THANKED HER FOR THE SUPPORT ON THAT; RIGHT?

MR. WADE: BUT IN REALITY, THIS WASN'T A TOUGH CALL, WAS IT?

MR. WADE: AND YOU HAD TO TAKE ACTIONS ONCE YOU HAD THOSE KINDS OF CONCERNS; RIGHT?

MR. WADE: LET'S GO TO 10639. DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU?

MR. WADE: AND THIS IS, THIS IS A DOCUMENT WHERE YOU JUST ARE PROVIDING AN UPDATE TO MS. HOLMES ON REPORTING STRUCTURES AND SOME WORK YOU WERE DOING WITHIN THE LAB; CORRECT?

MR. WADE: MOVE THE ADMISSION OF 10639.

MR. LEACH: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10639 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND I DON'T NEED TO SPEND A LOT OF TIME ON THIS, BUT YOU WERE WORKING ON REVAMPING THE REPORTING STRUCTURE AND THE ORGANIZATIONAL STRUCTURE IN THE LAB; RIGHT?

MR. WADE: AND YOU WERE GIVING MS. HOLMES AN UPDATE ON THAT; RIGHT?

MR. WADE: AND SHE WAS FULLY SUPPORTIVE OF THE EFFORTS THAT YOU WERE UNDERTAKING IN THAT REGARD; IS THAT FAIR?

MR. WADE: LET'S LOOK AT 10675.

MR. WADE: DO YOU RECALL THAT, AS PART OF THE WORK THAT YOU WERE DOING TO IMPROVE THE LAB, THAT YOU WERE WORKING TO FIND A THIRD PARTY WHO COULD COME IN AND DO SOME TESTING ON LABORATORY QUALITY?

KINGSHUK DAS: IF I MAY, MR. WADE? IF I MAY MAKE A SLIGHT CLARIFICATION OF THAT?

KINGSHUK DAS: WE WERE LOOKING FOR A QUALITY MANAGER --

KINGSHUK DAS: -- TO HIRE.

MR. WADE: TO HIRE?

MR. WADE: AND DOES THIS EMAIL RELATE TO THAT?

KINGSHUK DAS: I BELIEVE SO.

MR. WADE: MOVE THE ADMISSION OF 10675.

MR. LEACH: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10675 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND IF I COULD FOCUS -- DR. TSCHIRHART DRAFTED AN EMAIL THERE. DO YOU SEE THAT?

MR. WADE: AND IT NOTES -- DO YOU KNOW WHO MS. ABBOTT WAS?

KINGSHUK DAS: I DON'T RECALL.

MR. WADE: AND IT WAS A CANDIDATE POTENTIALLY FOR THAT POSITION, OR SOMEONE WHO MIGHT REFER SOMEONE?

MR. WADE: AND DO YOU RECALL BEING REFERRED BY DR. KRICKA?

KINGSHUK DAS: I DON'T RECALL THAT SPECIFICALLY.

MR. WADE: OKAY. BUT IN ANY EVENT, DOES THIS FAIRLY DESCRIBE THE TYPE OF PERSON WHO YOU WERE LOOKING FOR TO COME IN AND DIG IN ON QUALITY ISSUES?

MR. WADE: OKAY. MR. LEACH ASKED YOU SOME QUESTIONS ABOUT THE ARIZONA LAB. DO YOU RECALL THAT?

MR. WADE: AND THAT WAS -- AND YOU BECAME GENERALLY FAMILIAR WITH WHAT WAS -- THAT THERE WAS AN ARIZONA LAB; RIGHT?

MR. WADE: BUT YOU WEREN'T THE LABORATORY DIRECTOR OF THAT LAB?

MR. WADE: AND YOU UNDERSTOOD THAT THAT LAB WAS LOCATED IN CLOSE PROXIMITY TO THE WALGREENS LOCATIONS AT WHICH THERANOS WAS COLLECTING SAMPLES?

KINGSHUK DAS: I DON'T RECALL THE LOCATION OF THE LAB WITH RESPECT TO WALGREENS. IT WAS LOCATED IN SCOTTSDALE, I BELIEVE.

MR. WADE: IT WAS LOCATED IN SCOTTSDALE. AND DO YOU RECALL THAT THERANOS HAD SOME WALGREENS PATIENT SERVICE CENTERS IN THE GREATER PHOENIX AREA?

MR. WADE: OKAY. AND THERE WERE SOME QUESTIONS ABOUT THE PROPORTION OF TESTS THAT WERE DONE THERE. DO YOU RECALL THAT?

MR. WADE: AND YOU DIDN'T RECALL THAT, DID YOU?

KINGSHUK DAS: NO, I DON'T BELIEVE I DID.

MR. WADE: GENERALLY DO YOU RECALL THAT YOU WERE LOOKING -- LET ME STRIKE THAT AND START OVER. AS PART OF YOUR WORK, YOU WERE LOOKING BACK OVER A RANGE OF TESTS AT THERANOS; CORRECT?

MR. WADE: AND DO YOU RECALL THAT IN THE TIME PERIOD IT WAS OPERATING AS A CLINICAL LABORATORY, THAT IT PERFORMED A LITTLE MORE THAN 8 MILLION TESTS?

KINGSHUK DAS: I DON'T RECALL THAT NUMBER SPECIFICALLY.

MR. LEACH: I OBJECT TO THE QUESTION. CAN WE BE CLEAR ABOUT WHICH LAB WE'RE TALKING ABOUT?

JUDGE DAVILA: DID YOU UNDERSTAND THE QUESTION, SIR?

KINGSHUK DAS: I COULD USE SOME CLARIFICATION, YOUR HONOR.

JUDGE DAVILA: OKAY. WHY DON'T WE -- WHY DON'T YOU ASK THE QUESTION AGAIN.

MR. WADE: FAIR ENOUGH.

MR. WADE: JUST TO BE CLEAR, I'M ASKING GENERALLY. YOU DIDN'T RECALL THE PROPORTIONS FROM ONE LAB TO THE NEXT?

MR. WADE: AND MY QUESTION WAS WHETHER YOU RECALLED THAT, IN TOTAL, THE ENTITY PERFORMED ABOUT 8 MILLION TESTS?

KINGSHUK DAS: I DON'T RECALL THAT NUMBER SPECIFICALLY.

MR. WADE: OKAY. DO YOU HAVE A GENERAL RECOLLECTION?

KINGSHUK DAS: I WAS MORE FAMILIAR WITH A NUMBER IN THE RANGE OF 800-, 900,000.

MR. WADE: THAT WAS IN THE NEWARK LAB?

KINGSHUK DAS: YES, BUT THAT'S THE NUMBER WITH WHICH I'M FAMILIAR.

MR. WADE: UNDERSTOOD. I JUST WANT TO MAKE SURE THAT THE RECORD IS CLEAR. YOU UNDERSTOOD THAT THE NEWARK LAB HAD PERFORMED ABOUT THAT NUMBER OF TESTS ON AN ANNUAL BASIS; CORRECT?

MR. WADE: OKAY. AND AS YOU SIT HERE TODAY, YOU DON'T KNOW THE TOTAL NUMBER OF TESTS THAT THE COMPANY AS A WHOLE WAS PERFORMING AT DIFFERENT LOCATIONS?

MR. WADE: OKAY. DO YOU RECALL THERE WAS A TIME PERIOD WHEN YOU BEGAN DOING A LITTLE MORE WORK ON SOME R&D ISSUES AS WELL?

KINGSHUK DAS: I NEED A LITTLE BIT OF SPECIFICITY THERE AS WELL, MR. WADE.

MR. WADE: SURE. THERE WERE TIMES WHERE YOUR INPUT WAS SOUGHT ON DIFFERENT R&D MATTERS THAT THE COMPANY WAS WORKING ON; IS THAT CORRECT?

MR. WADE: IN FACT, THERE CAME A TIME WHERE, IN ADDITION TO YOUR OFFICE OVER AT THE NEWARK FACILITY, YOU WERE SPENDING SOME TIME OVER AT THE PALO ALTO FACILITY AS WELL?

MR. WADE: AND THAT WAS WHERE THE R&D WORK WAS HAPPENING?

KINGSHUK DAS: PREDOMINANTLY, YES.

MR. WADE: AND THAT WAS AN AREA THAT INTERESTED YOU; IS THAT RIGHT?

MR. WADE: AND YOU WERE ASKED TO PARTICIPATE IN DIFFERENT ASPECTS OF THAT IN YOUR TENURE AT THE COMPANY; CORRECT?

MR. WADE: LET'S TAKE A LOOK AT 10638.

MR. WADE: AND DOES THIS EMAIL RELATE -- THIS IS AN EMAIL FROM MAY 16TH, 2016; CORRECT?

MR. WADE: AND IT'S AN EMAIL THAT YOU SENT TO MS. HOLMES?

MR. WADE: AND IT RELATES TO SOME FEEDBACK THAT YOU WERE PROVIDING ON SOME R&D ISSUES; IS THAT FAIR?

KINGSHUK DAS: I DON'T RECALL THE CONTEXT FOR THIS EMAIL.

MR. WADE: DO YOU RECALL PARTICIPATING IN AN R&D CALL WHERE SOME ISSUES WERE DISCUSSED AND YOU THOUGHT THAT YOU SHOULD PROVIDE SOME PERSPECTIVE TO MS. HOLMES?

KINGSHUK DAS: I DON'T RECALL THAT.

MR. WADE: OKAY. DO YOU RECALL, IN CONNECTION WITH R&D WORK, BEING ASKED TO PROVIDE SOME THOUGHTS IN CONNECTION WITH THE TYPES OF STANDARDS THAT THE COMPANY SHOULD USE IN CONNECTION WITH THE VALIDATION OF ASSAYS?

KINGSHUK DAS: YES. VAGUELY THOUGH.

MR. WADE: OKAY. AND WE TALKED ABOUT THAT BEFORE IN CONNECTION WITH SOME OF THE EDISON 3.5 ASSAYS. DO YOU RECALL THAT?

MR. WADE: AND DO YOU RECALL THAT AS THE COMPANY WAS WORKING TO DEVELOP ITS NEXT GENERATION DEVICE, THAT IT WANTED YOUR INPUT ON THE RIGHT STANDARDS TO USE AS IT WAS IMPLEMENTING ITS NEXT TECHNOLOGY?

KINGSHUK DAS: I RECALL BEING CONSULTED FROM TIME TO TIME.

MR. WADE: OKAY. MOVE THE ADMISSION OF 10638.

MR. LEACH: NO OBJECTION, YOUR HONOR.

JUDGE DAVILA: IT'S ADMITTED.

(DEFENDANT'S EXHIBIT 10638 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND DO YOU SEE HERE THAT THIS REFERS TO AN R&D CALL IN THE SUBJECT LINE?

MR. WADE: AND YOU REFERENCE A DISCUSSION AND YOU TALK ABOUT ALLOWABLE BIAS AND TOTAL ALLOWABLE ERROR FOR POTASSIUM THERE. DO YOU SEE THAT?

MR. WADE: AND YOU SET FORTH SOME THOUGHTS AS TO WHAT APPROPRIATE STANDARDS MIGHT BE FOR THAT; RIGHT?

MR. WADE: AND YOU NOTE THERE IN THE SECOND PARAGRAPH, SECOND SENTENCE, THAT YOU USE CLIA AS A LAST RESORT SINCE IT'S AKIN TO HITTING THE BROAD SIDE OF A BARN?

MR. WADE: AND SO BASED ON YOUR EXPERTISE HERE, YOU WERE OF THE VIEW THAT YOU SHOULDN'T USE THE CLIA STANDARD AS THE BENCHMARK FOR TOTAL ALLOWABLE ERROR; RIGHT?

KINGSHUK DAS: YES. THAT WOULD BE INAPPROPRIATE.

MR. WADE: OKAY. AND WERE YOU RELAYING THIS TO MS. HOLMES SO THAT SHE HAD THE BENEFIT OF YOUR EXPERTISE ON THIS ISSUE?

MR. WADE: AND YOU ACTUALLY REFER TO A DIFFERENT SET OF STANDARDS THAT COULD BE USED THERE BASED ON CALLUM FRASER'S WORK? DO YOU SEE THAT?

MR. WADE: AND THAT WAS REFERENCED IN THE RICOS HANDBOOK, WHICH I THINK IS AVAILABLE ON THE INTERNET AS WELL; CORRECT?

MR. WADE: AND THIS WAS AN INSTANCE WHERE YOU WERE TRYING TO GET INVOLVED IN THE R&D THAT THE COMPANY WAS WORKING ON AND GIVE THEM AN APPROPRIATE CLIA LENS AND STANDARD TO DEVELOP THEIR TECHNOLOGY BASED UPON; IS THAT RIGHT?

MR. WADE: AND IN CONNECTION WITH THE DEVELOPMENT OF THAT TECHNOLOGY, YOU'RE AWARE THAT A PRESENTATION WAS GIVEN OF THE NEXT GENERATION DEVICE AT THE AACC CONFERENCE IN AUGUST OF 2016?

MR. WADE: AND YOU DID NOT, YOU DID NOT ATTEND THAT CONFERENCE; CORRECT?

MR. WADE: BUT YOU WATCHED THAT PRESENTATION OVER A VIDEO LINK; RIGHT?

KINGSHUK DAS: I DID NOT VIEW THE PRESENTATION.

MR. WADE: LET ME SEE IF I CAN REFRESH YOUR RECOLLECTION. COULD YOU LOOK AT 14160?

MR. WADE: AND IF I COULD JUST CALL YOUR ATTENTION TO THE ITEM RELATING TO AUGUST 2ND, 2016. DO YOU SEE THAT? AND JUST READ THAT TO YOURSELF.

(PAUSE IN PROCEEDINGS.)

KINGSHUK DAS: I'VE READ IT.

BY MR. WADE:

MR. WADE: DOES THAT REFRESH YOUR RECOLLECTION THAT YOU WATCHED AT LEAST PORTIONS OF THE AACC CONFERENCE IN YOUR OFFICE?

KINGSHUK DAS: YES. I DON'T RECALL DOING SO, BUT IT APPEARS THAT I DID.

MR. WADE: AND MAYBE YOU RECALL THAT IT WAS ACTUALLY RECORDED AND AVAILABLE ONLINE?

KINGSHUK DAS: RIGHT, YES, I'M AWARE OF THAT.

MR. WADE: AND YOU'VE SEEN PART OF THAT?

MR. WADE: AND DO YOU RECALL BEING OF THE VIEW THAT MS. HOLMES DID A GOOD JOB IN THAT PRESENTATION?

MR. WADE: AND THAT YOU THOUGHT THAT SOME OF THE FOCUS ON THAT PRESENTATION WAS, WAS NARROW MINDED?

KINGSHUK DAS: IT APPEARS SO. I DON'T RECALL THAT.

MR. WADE: OKAY. BUT YOU WERE COMPLIMENTARY OF THE WORK THAT SHE HAD DONE THERE; IS THAT RIGHT?

MR. WADE: AND DO YOU RECALL DURING THAT PRESENTATION SOME SLIDES WERE PROJECTED?

MR. WADE: OKAY. MAY I APPROACH, YOUR HONOR?

BY MR. WADE:

MR. WADE: (HANDING.) HAVE YOU HAD A CHANCE TO JUST GENERALLY PERUSE THE SLIDE PRESENTATION?

KINGSHUK DAS: IT DOES LOOK FAMILIAR.

MR. WADE: DO YOU RECOGNIZE THIS TO BE THE SLIDES THAT WERE PRESENTED DURING THAT PRESENTATION?

KINGSHUK DAS: THEY'RE CONSISTENT WITH MY RECOLLECTION.

MR. WADE: MOVE THE ADMISSION OF 7673A.

MR. LEACH: OBJECTION, YOUR HONOR. RELEVANCE, HEARSAY.

JUDGE DAVILA: SUSTAINED.

BY MR. WADE:

MR. WADE: YOUR UNDERSTANDING WAS PART OF THAT PRESENTATION WAS AN EFFORT THAT THE COMPANY WAS MAKING TO ENGAGE IN SOME SCIENTIFIC DIALOGUE WITH THE BROADER CLINICAL LABORATORY COMMUNITY?

MR. WADE: AND AN EFFORT TO TRY TO BE MORE TRANSPARENT ABOUT THE PRODUCT THAT IT WAS DEVELOPING?

MR. WADE: ABOUT ITS TECHNOLOGY?

MR. WADE: AND WHAT IT THOUGHT ITS TECHNOLOGY COULD DO? DO YOU RECALL THAT?

MR. LEACH: OBJECTION. FOUNDATION.

JUDGE DAVILA: WELL, I'LL ALLOW HIM TO ANSWER THIS LAST QUESTION. DO YOU RECALL THAT, SIR?

KINGSHUK DAS: I DO, YOUR HONOR.

BY MR. WADE:

MR. WADE: OKAY. AND IN ADDITION TO THAT PRESENTATION, THE COMPANY WAS WORKING ON PUBLICATIONS AND ENGAGING WITH OTHER MEDICAL INSTITUTIONS TO TRY TO INCREASE TRANSPARENCY; IS THAT RIGHT?

KINGSHUK DAS: YES. JUST AS A MATTER OF CLARIFICATION, I BELIEVE IT WAS ONE INSTITUTION THAT I WAS AWARE OF. BUT, YES.

MR. WADE: AND WHAT INSTITUTION WAS THAT?

KINGSHUK DAS: I BELIEVE IT WAS UCSF.

MR. WADE: IT WAS UCSF THAT THEY WERE WORKING WITH ON A STUDY?

MR. WADE: THE COURT'S INDULGENCE FOR A MOMENT?

(DISCUSSION AMONGST DEFENSE COUNSEL OFF THE RECORD.)

BY MR. WADE:

MR. WADE: JUST A COUPLE MORE QUESTIONS FOR YOU, SIR. AT THE -- DO YOU RECALL ABOUT WHEN YOU LEFT, YOU STOPPED WORKING AT THERANOS?

KINGSHUK DAS: THAT WOULD HAVE BEEN JUNE OF 2018, I BELIEVE.

MR. WADE: OKAY. AND AT THE TIME THAT YOU LEFT THE COMPANY -- YOU STARTED AT THE COMPANY WITH MS. HOLMES COMMUNICATING TO HER ABOUT HOW IMPRESSED YOU WERE WITH THE VISION SHE HAD AND WHAT SHE WAS TRYING TO ACCOMPLISH; CORRECT?

MR. WADE: AND AT THE TIME THAT YOU LEFT THE COMPANY, DID YOU STILL BELIEVE IN THE MISSION AND WHAT IT HAD HOPED TO ACCOMPLISH?

MR. WADE: NO FURTHER QUESTIONS, YOUR HONOR.

MR. LEACH: YES, YOUR HONOR. BRIEFLY.

(PAUSE IN PROCEEDINGS.)

JUDGE DAVILA: FOLKS, GO AHEAD AND STAND UP AND STRETCH IF YOU WOULD LIKE WHILE WE MAKE THE TRANSITION HERE. YOU, TOO, DOCTOR. GO AHEAD AND STAND UP AND STRETCH IF YOU WOULD LIKE.

KINGSHUK DAS: THANK YOU, YOUR HONOR.

JUDGE DAVILA: YOU'RE WELCOME.

(STRETCHING.)

MR. WADE: LET ME GET MY WATER HERE.

MR. LEACH: THANK YOU. MAY I INQUIRE, YOUR HONOR?

MR. WADE: THANK YOU.

REDIRECT EXAMINATION BY MR. LEACH:

MR. LEACH: GOOD AFTERNOON, DR. DAS. I JUST HAVE A FEW QUESTIONS. YOU WERE ASKED A NUMBER OF QUESTIONS ON CROSS-EXAMINATION ABOUT THERANOS'S NEXT GENERATION DEVICE. DO YOU RECALL QUESTIONS ALONG THOSE LINES?

MR. LEACH: AND DO YOU RECALL REVIEWING A PHOTO OF THE INSIDE OF ONE OF THE NEXT GENERATION DEVICES?

MR. LEACH: AND YOU WERE ASKED SOME QUESTIONS ABOUT A PRESENTATION AT AACC WHERE THERE WAS DISCUSSION ABOUT THE NEXT GENERATION DEVICE. DO YOU RECALL THAT?

MR. LEACH: AND THAT NEXT GENERATION DEVICE WAS NEVER USED IN THE CLINICAL LAB; CORRECT?

MR. LEACH: IT WAS NEVER USED TO TEST PATIENT SAMPLES IN THE LAB THAT YOU WERE OPERATING; RIGHT?

MR. LEACH: AND TO YOUR KNOWLEDGE, IT WAS NEVER USED IN THE ARIZONA MODERATE COMPLEXITY LAB; IS THAT CORRECT?

MR. LEACH: YOU WERE ALSO ASKED A NUMBER OF QUESTIONS ABOUT ACTIONS THAT YOU WERE TAKING AND STEPS THAT THE COMPANY WAS TAKING IN 2016. AND I WANT TO MAKE SURE -- I WANT TO GO THROUGH THAT TIMELINE WITH YOU IF WE COULD.

MR. LEACH: WAS IT YOUR UNDERSTANDING THAT THERANOS FIRST OBTAINED ITS CLIA LICENSE IN 2011?

KINGSHUK DAS: I DON'T HAVE RECOLLECTION OF THAT DATE.

MR. LEACH: WELL, YOU STARTED IN 2015; IS THAT RIGHT?

MR. LEACH: AND WHEN YOU STARTED THE LAB WASN'T NEW? IT HAD BEEN OPERATING FOR YEARS BASED ON YOUR UNDERSTANDING?

KINGSHUK DAS: YES, THAT WAS MY UNDERSTANDING.

MR. LEACH: AND IF I COULD PLEASE DISPLAY, WITH THE COURT'S PERMISSION, WHAT IS IN EVIDENCE AS EXHIBIT 4528.

MR. LEACH: I THINK THIS IS A NATIVE DOCUMENT, MS. HOLLIMAN. IF WE CAN ZOOM IN ON THE FIRST PAGE OF THE POWERPOINT.

MR. LEACH: DR. DAS, DO YOU SEE WHERE IT SAYS THERANOS CLIA LABORATORY OVERVIEW 9-22-15?

MR. LEACH: AND I WANT TO FOCUS ON THAT DATE, SEPTEMBER 22ND, 2015. DID YOU HAVE AN UNDERSTANDING THAT THAT WAS THE DATE WHEN CMS'S SURVEY BEGAN?

KINGSHUK DAS: I WASN'T AWARE OF THAT EXACT DATE.

MR. LEACH: BUT YOU KNEW IT HAD STARTED AT SOME POINT BEFORE YOU JOINED?

MR. LEACH: MS. HOLLIMAN, IF WE COULD PLEASE GO TO PAGE 8. DO YOU SEE THE CLIA LABORATORIES ORG CHART ON THIS SLIDE, DR. DAS?

MR. LEACH: AND DO YOU SEE MS. HOLMES'S NAME AT THE TOP?

MR. LEACH: OKAY. YOU TALKED ABOUT A NUMBER OF PEOPLE ON YOUR DIRECT EXAMINATION, ARTHUR BACA, FRANCIS YOUNG, MICHELE CARBONE, DR. HELFEND. ARE THOSE ALL INDIVIDUALS WHO JOINED THE COMPANY AFTER SEPTEMBER OF 2015?

MR. LEACH: AND AT SOME POINT DID YOU BECOME AWARE THAT IN OCTOBER OF 2015, THERE WAS AN ARTICLE IN "THE WALL STREET JOURNAL" GENERALLY CRITICAL OF THERANOS?

MR. LEACH: AND YOU WERE COMING ON BOARD AFTER THAT ARTICLE HAD BEEN PUBLISHED?

MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO EXHIBIT 4621, WHICH IS IN EVIDENCE. LET'S GO TO PAGE 1. AND IF WE COULD GO DOWN TO THE START OF THE SECOND PARAGRAPH, MS. HOLLIMAN. DO YOU SEE, DR. DAS, WHERE IT SAYS, "THE ON-SITE SURVEY WAS COMPLETED ON NOVEMBER 20TH, 2015"? DO YOU SEE THAT LANGUAGE?

MR. LEACH: AND IS THAT YOUR UNDERSTANDING OF THE DATE WHEN CMS LARGELY COMPLETED ITS SURVEY?

MR. LEACH: OKAY. DO YOU KNOW WHETHER CMS PROVIDED AN EXIT INTERVIEW TO MS. HOLMES ON NOVEMBER 20TH, 2015?

KINGSHUK DAS: I'M NOT AWARE OF THAT.

MR. LEACH: DO YOU KNOW WHETHER CMS DESCRIBED ANY OF THE POTENTIAL FINDINGS TO MS. HOLMES AT THE COMPLETION OF THE SURVEY IN NOVEMBER OF 2015?

MR. LEACH: YOU INTERVIEWED WITH MS. HOLMES AT SOME POINT IN DECEMBER OF 2015?

MR. LEACH: AND DID SHE BRING UP THE CMS INSPECTION AT THAT POINT?

MR. LEACH: DID SHE MENTION ANYTHING ABOUT THE POSSIBILITY OF SOME FORM OF STATEMENT OF DEFICIENCIES?

MR. LEACH: AND YOU DON'T LEARN ABOUT THAT UNTIL YOU COME ON BOARD AT SOME POINT IN JANUARY OR FEBRUARY; IS THAT FAIR?

KINGSHUK DAS: I CAN'T REMEMBER THE EXACT DATE.

MR. LEACH: OKAY. THAT'S SOMETHING THAT YOU LEARNED OF AFTER YOU JOINED THE COMPANY?

MR. LEACH: THANK YOU, MS. HOLLIMAN. WE CAN TAKE THAT DOWN. YOU WERE ASKED A COUPLE OF QUESTIONS ON CROSS-EXAMINATION ABOUT OWNERS AND OPERATORS OF CLIA LABS. I WANT TO UNDERSTAND YOUR POSITION WITHIN THE THERANOS HIERARCHY. YOU REPORTED TO MS. HOLMES?

MR. LEACH: AND SO SHE'S THE ONE WHO HIRED YOU?

MR. LEACH: AND SHE IN THEORY COULD FIRE YOU AT ANY POINT? WAS THAT YOUR UNDERSTANDING?

MR. LEACH: IF SHE DIDN'T LIKE THE JOB YOU WERE DOING, SHE COULD FIRE YOU, JUST LIKE ANY EMPLOYEE AT ANY OTHER COMPANY?

MR. LEACH: AND IF YOU NEEDED RESOURCES FOR YOUR CLIA LAB, WHO WOULD YOU GO TO?

KINGSHUK DAS: I WOULD GO TO MS. HOLMES.

MR. LEACH: WHY WOULD YOU GO TO HER?

KINGSHUK DAS: SHE WOULD HAVE CONTROL OVER THE RESOURCES.

MR. LEACH: RESOURCES YOU WOULD NEED TO GET YOUR JOB DONE?

MR. LEACH: YOU WERE ALSO ASKED SOME QUESTIONS ABOUT A MOCK AUDIT AT SOME POINT IN ADVANCE OF SEPTEMBER 2015. DO YOU RECALL THOSE QUESTIONS?

KINGSHUK DAS: YES, I DO.

MR. LEACH: AND DO YOU RECALL THE NAME JERRY HURST BEING MENTIONED?

MR. LEACH: HAVE YOU EVER MET MR. HURST?

MR. LEACH: DO YOU HAVE ANY IDEA WHAT WAS DONE IN THAT AUDIT?

MR. LEACH: DO YOU KNOW WHETHER MR. HURST LOOKED AT AN EDISON DEVICE?

MR. LEACH: DO YOU KNOW WHETHER HE WAS SHOWN ANY DATA FROM AN EDISON DEVICE?

MR. LEACH: DO YOU KNOW WHETHER HE WAS SHOWN ANY DATA FROM TESTING ON MODIFIED THIRD PARTY DEVICES?

MR. LEACH: DO YOU KNOW WHETHER HE SAW A MODIFIED SIEMENS MACHINE?

MR. WADE: YOUR HONOR, FOUNDATION. I THINK WE'VE -- HE SAID HE DOESN'T KNOW WHAT HAPPENED AND --

JUDGE DAVILA: WELL, I'LL ALLOW IT. I THINK YOU'RE ABOUT DONE WITH THIS.

MR. LEACH: I'M ABOUT DONE, YOUR HONOR. THANK YOU.

MR. LEACH: YOU WERE ALSO ASKED SOME QUESTIONS ABOUT SOME OF THE QUALITY CONTROL DATA THAT WAS REPORTED IN THE CMS REPORT. DO YOU RECALL SOME QUESTIONS ABOUT THAT?

MR. LEACH: AND IN RESPONSE TO THE 2567, YOU REVIEWED NOT JUST THE QUALITY CONTROL DATA THAT WAS LISTED IN THE CMS REPORT, BUT A BROADER UNIVERSE OF DATA. IS THAT FAIR?

MR. LEACH: AND WHAT WAS THE REASON FOR DOING THAT?

KINGSHUK DAS: THAT WAS TO IDENTIFY THE EXTENT OF THE DEFICIENCY.

MR. LEACH: OKAY. AND AFTER THAT BROADER REVIEW, DID YOU VIEW THE INSTANCES THAT WERE LISTED BY CMS AS REPRESENTATIVE SAMPLES?

MR. LEACH: THOSE DIDN'T SEEM OUT OF -- UNUSUAL IN THE SENSE OF BEING ONE OFFS OR OUT OF THE ORDINARY?

KINGSHUK DAS: OUTLIERS? IS THAT CORRECT?

MR. LEACH: WE'VE USED THAT TERM IN SOME OTHER CONTEXTS. I JUST WANT TO MAKE SURE IF WHAT WAS REPORTED IN CMS WAS REPRESENTATIVE OF WHAT YOU SAW IN YOUR BROADER REVIEW.

MR. LEACH: YOU WERE ASKED A NUMBER OF QUESTIONS ABOUT THE VALIDATION REPORTS FOR ASSAYS RUN ON THE EDISON 3.5. DO YOU RECALL THAT TESTIMONY?

MR. LEACH: AND A VALIDATION REPORT IS THE DOCUMENT AT THE OUTSET OF TESTING WHEN YOU START USING A PARTICULAR ASSAY IN A PARTICULAR DEVICE IN THE LAB; IS THAT RIGHT?

MR. LEACH: IS THAT THE END OF THE MATTER WHEN IT COMES TO THE LAB DIRECTOR ASSESSING WHETHER THE ASSAY IS WORKING OR NOT WORKING?

MR. LEACH: HOW IS THAT NOT THE END OF THE MATTER?

KINGSHUK DAS: MAY I GET A LITTLE BIT OF SPECIFICITY THERE?

MR. LEACH: WELL, ARE THERE OTHER PROCEDURES IN A LAB TO MAKE SURE THAT, AFTER VALIDATION, THE ASSAY IS WORKING OR NOT WORKING AS IT'S SUPPOSED TO?

MR. LEACH: AND IS QUALITY CONTROL ONE OF THOSE?

KINGSHUK DAS: THAT IS THE CHIEF COMPONENT, YES.

MR. LEACH: AND IS QUALITY CONTROL, LIKE, THE ALARM BELL TO ASSESS WHETHER A PARTICULAR ASSAY IS WORKING OR NOT WORKING AS IT'S SUPPOSED TO?

MR. LEACH: OKAY. AND BASED ON YOUR REVIEW OF THE BROADER UNIVERSE OF QC DATA, WERE ALARM BELLS GOING OFF?

MR. LEACH: AT ANY TIME IN YOUR INITIAL INTERVIEW WITH MR. HOLMES, OR EVEN IN THE PERIOD UP THROUGH MARCH, DID ANYBODY EVER RAISE INSTANCES TO YOU WHERE FOLKS WITHIN THE CLIA LAB WERE RAISING ISSUES WITH RESPECT TO QUALITY CONTROL?

KINGSHUK DAS: COULD YOU ELABORATE A LITTLE BIT, PLEASE.

MR. LEACH: FOR EXAMPLE, IN YOUR INTERVIEW WITH MS. HOLMES OR IN YOUR FIRST FEW WEEKS AS YOU'RE COMING UP TO THE LAB, DID ANYBODY REPORT TO YOU ISSUES THAT HAD BEEN RAISED PREVIOUSLY WITHIN THE CLIA LAB BY INSIDERS WITHIN THE COMPANY?

MR. LEACH: DID ANYONE MENTION THE NAME ERIKA CHEUNG TO YOU?

MR. LEACH: DID ANYBODY MENTION THE NAME TYLER SHULTZ TO YOU?

MR. LEACH: AND DID ANYBODY DESCRIBE FOR YOU THE CIRCUMSTANCES UNDER WHICH DR. ROSENDORFF LEFT?

MR. LEACH: YOU WERE ALSO ASKED SOME QUESTIONS ABOUT EXHIBIT 14162. AND IF WE COULD PLEASE DISPLAY THAT, MS. HOLLIMAN. DO YOU RECALL BEING EXAMINED ABOUT YOUR APPROACH WITH RESPECT TO SOME PARTICULAR ASSAYS IN EXHIBIT 14162, DR. DAS?

MR. LEACH: I WANT TO WALK THROUGH SOME OF THE DETAILS OF THIS EMAIL AND MAKE SURE I UNDERSTAND THE CONTEXT OF YOUR COMMENT. IF WE CAN GO, PLEASE, TO I BELIEVE IT'S PAGE 5 OF THE DOCUMENT, MS. HOLLIMAN. AND IF WE CAN ZOOM IN ON THE PORTION BEGINNING, "THANKS FOR YOUR TIME YESTERDAY." DR. DAS, WHAT PARTICULAR ASSAYS AND DEVICES ARE BEING REFERENCED IN THIS EMAIL?

KINGSHUK DAS: I BELIEVE THESE WOULD BE THE MODIFIED ADVIA 18 ASSAYS.

MR. LEACH: AND THERE'S A REFERENCE TO SODIUM AND CALCIUM. DO YOU SEE THAT?

MR. LEACH: AND IF WE COULD NOW PLEASE GO TO YOUR COMMENT ON PAGE 2 AND ZOOM IN ON THE TOP EMAIL FROM DR. DAS ALL OF THE WAY DOWN TO THE -- ONE MORE PARAGRAPH IF WE COULD, MS. HOLLIMAN. IF WE COULD ZOOM DOWN A LITTLE BIT MORE TO THE SECOND PARAGRAPH, MS. HOLLIMAN. DO YOU HAVE THAT IN FRONT OF YOU, DR. DAS?

KINGSHUK DAS: YES, I DO.

MR. LEACH: OKAY. YOU WROTE, "I HAD A CHANCE TO TOUCH BASE WITH TINA AND DANIEL THE OTHER DAY TO GET DETAILS ON THE UPDATED PATIENT IMPACT ASSESSMENTS, AND I'VE DECIDED TO TAKE A MORE CONSERVATIVE APPROACH." IS THAT IN THE CONTEXT OF THESE ASSAYS RUN ON THE SIEMENS ADVIA?

MR. LEACH: AND JUST EXPLAIN FOR US WHAT YOU MEANT BY THAT.

KINGSHUK DAS: REGARDING THE PRIOR EMAIL, THERE WAS AN APPROACH OUTLINED THAT I DISAGREED WITH.

MR. LEACH: AND WHAT WAS THE APPROACH THAT YOU DISAGREED WITH?

KINGSHUK DAS: IF I REMEMBER CORRECTLY, THEY WERE PROPOSING A MORE LIBERAL APPROACH THAT WOULD REQUIRE MULTIPLE ANALYTES TO BE, QUOTE-UNQUOTE, ABNORMAL IN ORDER TO TRIGGER VOIDING OR CORRECTIONS, AND I DISAGREED WITH THAT ASSERTION.

MR. LEACH: AND YOU WANTED TO LOOK AT IT ANALYTE BY ANALYTE; IS THAT FAIR?

KINGSHUK DAS: YES, THAT WOULD BE THE CORRECT WAY TO DO IT.

MR. LEACH: AND WHEN YOU VOIDED TESTS ON THE EDISON 3.5 DEVICE, WERE YOU BEING CONSERVATIVE?

KINGSHUK DAS: CAN YOU CLARIFY, PLEASE.

MR. LEACH: DID YOU FEEL LIKE YOU WERE BEING CONSERVATIVE?

KINGSHUK DAS: I WAS JUST FOLLOWING THE DATA.

MR. LEACH: YOU WERE ALSO ASKED A NUMBER OF QUESTIONS ABOUT MS. HOLMES'S BACKGROUND AND EXPERIENCE. DO YOU RECALL THAT TESTIMONY?

MR. LEACH: OKAY. YOU WERE HIRED IN 2015?

MR. LEACH: OKAY. AT THAT POINT THERANOS HAD BEEN IN EXISTENCE FOR OVER 12 YEARS. WAS THAT YOUR UNDERSTANDING?

MR. LEACH: OKAY. AND SHE WAS THE CEO OF THE COMPANY; CORRECT?

MR. LEACH: AND WERE YOU AWARE THAT SHE HELD HERSELF OUT AS THE AUTHOR OF A NUMBER OF PATENTS?

MR. LEACH: WERE YOU AWARE THAT SHE HAD HELD HERSELF OUT TO MEDIA OUTLETS AS BEING THE LEADER OF THE COMPANY?

MR. LEACH: I'D ALSO LIKE TO ASK SOME QUESTIONS ABOUT EXHIBIT 10674. YOU WERE ASKED SOME QUESTIONS ABOUT GLUCOSE AND SODIUM VALIDATION DATA THAT YOU LOOKED AT IN APRIL OF 2016?

MR. LEACH: AND I THINK YOU WERE THEN SHOWN SOME QUESTIONS OR ASKED SOME QUESTIONS ABOUT SOME ADDITIONAL ASSAYS THAT HAD BEEN RUN ON THE MODIFIED SIEMENS MACHINE, AND YOU WERE ASKED WERE YOU COMFORTABLE WITH THE DATA, AND YOUR ANSWER WAS AT THAT POINT IN TIME. DO YOU RECALL THAT TESTIMONY?

MR. LEACH: AND WHAT DID YOU MEAN BY "AT THAT POINT IN TIME"?

KINGSHUK DAS: WE SUBSEQUENTLY TURNED OVER MORE ROCKS AND STONES.

MR. LEACH: YOU WERE ASKED A NUMBER OF QUESTIONS ABOUT A MEETING THAT YOU HAD WITH MS. HOLMES AND OTHERS ABOUT THE VOIDING OF THE TESTS. DO YOU RECALL THAT TESTIMONY?

MR. LEACH: AND I THINK YOU TESTIFIED THAT THERE WAS AGREEMENT TO VOID THE TESTS?

MR. LEACH: OKAY. DID YOU GET PUSHBACK FROM MS. HOLMES ABOUT HOW TO CHARACTERIZE THE VOIDING OF THE TESTS?

MR. LEACH: DESCRIBE THAT PUSHBACK FOR US, PLEASE?

KINGSHUK DAS: THERE WAS A CHARACTERIZATION FOR WHY THE VOIDING WAS DONE, TO WHICH I DISAGREED.

MR. LEACH: AND THAT CHARACTERIZATION WAS WHAT?

KINGSHUK DAS: THAT CHARACTERIZATION WAS THAT THE PROBLEMS WERE DUE TO ISSUES WITH QUALITY CONTROL AND QUALITY ASSURANCE RATHER THAN THE INSTRUMENT ITSELF.

MR. LEACH: AND THAT WAS COMMUNICATED -- THE IDEA THAT THIS WAS JUST A QUALITY SYSTEMS ISSUE WAS COMMUNICATED TO CMS; IS THAT CORRECT?

MR. LEACH: AND YOU DISAGREED WITH THAT?

MR. LEACH: MAY I HAVE A MOMENT, YOUR HONOR?

(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)

MR. LEACH: I HAVE NO FURTHER QUESTIONS, YOUR HONOR. THANK YOU. THANK YOU, DR. DAS.

KINGSHUK DAS: THANK YOU.

RECROSS-EXAMINATION BY MR. WADE:

MR. WADE: JUST A COUPLE MORE QUESTIONS, DR. DAS.

MR. WADE: YOU WERE JUST ASKED ABOUT THAT MEETING AND WHAT WAS COMMUNICATED TO CMS ABOUT THE REASONS FOR VOIDING. DO YOU RECALL THAT?

MR. WADE: AND THERE WERE A LOT OF -- I THINK WHEN YOU DESCRIBED THAT MEETING, YOU DESCRIBED THAT THERE WERE A LOT OF COOKS IN THE KITCHEN, IF YOU WILL?

KINGSHUK DAS: I DON'T RECALL THAT STATEMENT BUT --

MR. WADE: OKAY. YOU RECALL THAT THERE WERE SOME LAWYERS PRESENT AND SOME OTHER ADVISORS AND MS. HOLMES AND YOURSELF?

MR. WADE: AND THEN THE OUTGROWTH OF THAT MEETING WAS THE PREPARATION OF SOME COMMUNICATIONS TO CMS PROVIDING INFORMATION ABOUT THE VOIDING. DO YOU RECALL THAT?

MR. WADE: AND WE LOOKED AT THAT PATIENT IMPACT ASSESSMENT YESTERDAY. DO YOU RECALL THAT?

MR. WADE: AND THAT RELATED TO THE EDISON 3.5 DEVICE; RIGHT?

MR. WADE: AND THAT SET FORTH THE QUALITY CONTROL AND QUALITY ASSURANCE CONCERNS AS A BASIS TO VOID THE TESTS; CORRECT?

KINGSHUK DAS: IN PART, YES.

MR. WADE: AND YOU BELIEVED THAT WAS A BASIS TO VOID THE TESTS; CORRECT?

KINGSHUK DAS: THE QUALITY CONTROL RESULTS? YES.

MR. WADE: YEAH. AND THE -- WHAT THAT BUCKET ON QUALITY CONTROL AND QUALITY ASSURANCE THAT YOU HAD IDENTIFIED AS YOU WERE TURNING OVER THOSE ROCKS, YOU FELT AS A RESULT OF THAT YOU SHOULD VOID THE EDISON RESULTS; CORRECT?

KINGSHUK DAS: YES, IN PART.

MR. WADE: AND THAT STATEMENT WAS PUT INTO A LETTER THAT WAS DRAFTED AND SENT TO CMS; RIGHT?

KINGSHUK DAS: YES, I BELIEVE SOME OF VERBIAGE WAS THERE.

MR. WADE: AND YOU SIGNED THE LETTER, RIGHT, SIR?

MR. WADE: AND YOU WERE COMFORTABLE WITH IT AT THAT TIME?

KINGSHUK DAS: I BELIEVE I DISAGREED WITH THAT PARTICULAR CHARACTERIZATION, BUT THE LETTER AS A WHOLE WAS ACCEPTABLE.

MR. WADE: AND YOU -- IN FACT, YOU RECALL THAT THERE WERE TWO LETTERS. THERE WAS ONE SENT MARCH 28TH. DO YOU RECALL THAT?

KINGSHUK DAS: I COULD USE A REFRESHER, PLEASE.

MR. WADE: SURE. LET'S SEE IF WE CAN FIND THIS. THE COURT'S INDULGENCE FOR A MOMENT?

BY MR. WADE:

MR. WADE: IT WILL BE IN THE WHITE BINDER. AND LOOK AT 5260.

MR. WADE: DOES THAT REFRESH YOUR RECOLLECTION THAT THERE WAS A LETTER SENT TO CMS ON MARCH 28TH, 2016?

MR. WADE: AND YOU SIGNED THIS LETTER; CORRECT?

KINGSHUK DAS: I BELIEVE SO, YES.

MR. WADE: AND WAS IT YOUR RECOLLECTION, WAS THIS LETTER PREPARED BY THE LAWYERS WHO WERE ADVISING THE COMPANY?

MR. WADE: OKAY. AND THEN AFTER THEY PREPARED IT, YOU REVIEWED AND SENT IT TO THE COMPANY, OR SENT IT TO CMS; CORRECT?

MR. WADE: AND THEN THERE WAS ANOTHER SIMILAR LETTER THAT WAS SENT APRIL 1ST; IS THAT CORRECT?

KINGSHUK DAS: I DON'T RECALL THE EXACT DATE, BUT --

MR. WADE: I'LL CALL YOUR ATTENTION TO 5471.

KINGSHUK DAS: YES, APRIL 1ST.

MR. WADE: AND AGAIN, THIS WAS A LETTER THAT WAS PREPARED BY COUNSEL; CORRECT?

MR. WADE: AND YOU SIGNED THAT LETTER; CORRECT?

MR. WADE: AND DO YOU KNOW, WAS THE COUNSEL WHO PREPARED IT THE LAWYER WHO WAS IN THE ROOM MEETING WITH YOU AND MS. HOLMES?

MR. WADE: THE, THE -- MR. LEACH TALKED TO YOU ABOUT HOW MS. HOLMES HAD SOME EXPERIENCE. DO YOU RECALL THAT?

MR. WADE: AND TO BE SURE, THE COMPANY HAD BEEN AROUND FOR A WHILE AT THAT TIME; IS THAT CORRECT?

MR. WADE: BUT BASED UPON YOUR INTERACTIONS WITH HER, DID YOU FEEL THAT SHE WAS -- SHE HAD EXPERIENCE IN CLIA LABORATORY OPERATIONS?

MR. WADE: OR CLIA LABORATORY REGULATIONS?

MR. WADE: OR EXPERTISE IN VALIDATION?

MR. WADE: OR EXPERTISE IN PATHOLOGY?

MR. WADE: OR THE APPROPRIATE BENCHMARKS FOR VALIDATION?

MR. WADE: OR THE WAY IN WHICH TO RUN A QUALITY CONTROL PROGRAM?

MR. WADE: AND UNTIL SHE WAS REPORTING TO YOU, SHE HAD NEVER HAD A LABORATORY DIRECTOR REPORT DIRECTLY TO HER TO YOUR KNOWLEDGE; CORRECT?

KINGSHUK DAS: I'M NOT AWARE OF THAT. I DON'T KNOW.

MR. WADE: MR. LEACH ASKED YOU SOME QUESTIONS ABOUT THAT BROADER REVIEW THAT WAS DONE AND SOME OF THE CONCLUSIONS THAT YOU CAME TO BASED UPON THAT REVIEW?

MR. WADE: DO YOU RECALL THAT? AND THAT WAS SOMETHING THAT THIS WHOLE TEAM OF PEOPLE THAT HAD BEEN BROUGHT TOGETHER ENGAGED IN; CORRECT?

MR. WADE: AND THOSE PEOPLE WERE OUTSIDE PEOPLE WHO DID COME IN AFTER THAT SEPTEMBER 2015 INSPECTION; RIGHT?

MR. WADE: THERE WAS A DESIRE TO HAVE THE OUTSIDE, OUTSIDER'S PERSPECTIVE ON THESE ISSUES; CORRECT?

KINGSHUK DAS: I'M NOT AWARE OF THE DESIRE OR THE INTENT.

MR. WADE: BUT IN ANY EVENT, THE PEOPLE CAME IN ANEW TO LOOK AT THESE ISSUES; RIGHT?

MR. WADE: AND TO TURN OVER THOSE ROCKS?

MR. WADE: AND THAT WAS A HARD AND DIFFICULT PROCESS FOR THE TEAM THAT WAS INVOLVED; RIGHT?

MR. WADE: AND DO YOU RECALL DESCRIBING, AS YOU TALKED ABOUT, AS YOU WERE WORKING THROUGH THAT PROCESS, LIKENING IT TO A FAVORITE MOVIE QUOTE THAT YOU HAVE?

KINGSHUK DAS: I RECALL WRITING A MOVIE QUOTE AT SOME POINT. I DON'T RECALL THE EXACT QUOTE.

MR. WADE: AND WHAT IS THAT MOVIE QUOTE?

KINGSHUK DAS: I DON'T REMEMBER THAT OFF THE TOP OF MY HEAD.

MR. WADE: OKAY. DO YOU RECALL IT BEING ABOUT "EVERYTHING WILL BE RIGHT IN THE END, AND IF IT'S" --

KINGSHUK DAS: CORRECT, YES. I'M SORRY TO SPEAK OVER YOU, BUT I BELIEVE THAT WAS A QUOTE FROM "THE BEST EXOTIC MARIGOLD HOTEL."

MR. WADE: AND WHAT DO YOU RECALL THE QUOTE?

KINGSHUK DAS: DO WE HAVE IT HERE? I DON'T THINK I'LL DO IT JUSTICE.

MR. WADE: IS IT SOMETHING TO THE EFFECT OF "EVERYTHING WILL BE ALL RIGHT IN THE END AND IF IT'S NOT ALL RIGHT, IT'S NOT YET THE END"?

MR. WADE: NO FURTHER QUESTIONS.

MR. LEACH: NOTHING FURTHER, YOUR HONOR.

JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?

MR. WADE: YES, YOUR HONOR.

JUDGE DAVILA: THANK YOU, SIR. YOU'RE EXCUSED. YOU CAN LEAVE THOSE BINDERS THERE.

KINGSHUK DAS: OKAY. THANK YOU.

JUDGE DAVILA: DOES THE GOVERNMENT HAVE ANOTHER WITNESS?

MR. BOSTIC: YES, YOUR HONOR. THE UNITED STATES CALLS ALAN EISENMAN.

JUDGE DAVILA: FOLKS, WE'LL BE BREAKING AT 1:30. IF YOU WANT TO TAKE STRETCH, FEEL FREE.

(STRETCHING.)

JUDGE DAVILA: SIR, IF YOU'LL COME FORWARD, PLEASE. I'LL INVITE YOU TO FACE OUR COURTROOM DEPUTY HERE. RAISE YOUR RIGHT HAND WHILE YOU DO SO, SHE HAS A QUESTION FOR YOU.

COURT CLERK: GOOD AFTERNOON.

KINGSHUK DAS: GOOD AFTERNOON.

(GOVERNMENT'S WITNESS, ALAN EISENMAN, WAS SWORN.)

JUDGE DAVILA: PLEASE HAVE A SEAT HERE, SIR. LET ME INVITE YOU TO MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THE CHAIR AND THE MICROPHONE AS YOU NEED. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. WHEN YOU ARE COMFORTABLE --

KINGSHUK DAS: IS IT OKAY TO TAKE THIS OFF?

JUDGE DAVILA: HAVE YOU BEEN VACCINATED, SIR?

KINGSHUK DAS: YES, I HAVE.

JUDGE DAVILA: YES, THAT'S FINE.

KINGSHUK DAS: THANK YOU.

JUDGE DAVILA: WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND THEN SPELL IT, PLEASE.

KINGSHUK DAS: MY NAME IS ALAN EISENMAN. A-L-A-N, E-I-S-E-N-M-A-N.

JUDGE DAVILA: THANK YOU. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE AS YOU CAN. MR. BOSTIC?

MR. BOSTIC: THANK YOU, YOUR HONOR.