Elizabeth A. Holmes — Direct (Continued)
866 linesSAN JOSE, CALIFORNIA NOVEMBER 22, 2021 P R O C E E D I N G S
(COURT CONVENED AT 8:39 A.M.)
(SEALED PROCEEDINGS IN CHAMBERS.) ///
(JURY IN AT 10:42 A.M.)
JUDGE DAVILA: THANK YOU ALL. THANK YOU FOR YOUR COURTESY. WE ARE ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. OUR JURY IS PRESENT. THANK YOU, LADIES AND GENTLEMEN. SORRY FOR THE DELAY THIS MORNING. LET ME -- BEFORE WE ASK MS. HOLMES TO RETURN TO THE STAND, LET ME ASK OUR JURORS AGAIN, OVER THE WEEKEND HAVE ANY OF YOU HAD OCCASION TO READ, DISCUSS, OR COME ACROSS ANY INFORMATION REGARDING THIS CASE? IF SO, PLEASE RAISE YOUR HANDS SO WE CAN DISCUSS IT. I SEE NO HANDS. THANK YOU. I'LL ASK MS. HOLMES IF YOU WOULD PLEASE RETURN TO THE STAND. AGAIN, MAKE YOURSELF COMFORTABLE. ADJUST THE CHAIR AND THE MICROPHONE AS YOU NEED. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. YOU CAN REMOVE YOUR MASK IF YOU WISH. IF YOU COULD JUST STATE YOUR NAME, PLEASE.
ELIZABETH A. HOLMES: MY NAME IS ELIZABETH HOLMES.
JUDGE DAVILA: THANK YOU. I'LL REMIND YOU THAT YOU ARE STILL UNDER OATH.
(DEFENDANT'S WITNESS, ELIZABETH HOLMES, WAS PREVIOUSLY SWORN.)
ELIZABETH A. HOLMES: THANK YOU.
JUDGE DAVILA: THANK YOU. MR. DOWNEY.
DIRECT EXAMINATION (RESUMED) BY MR. DOWNEY:
MR. DOWNEY: MS. HOLMES, DO YOU RECALL THAT WHEN WE LEFT OFF ON FRIDAY, WE WERE TALKING ABOUT A DEMONSTRATION THAT THERANOS HAD CONDUCTED AT NOVARTIS IN SWITZERLAND?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND WHAT SERIES OF THERANOS DEVICE WAS USED IN CONNECTION WITH THAT DEMONSTRATION?
ELIZABETH A. HOLMES: THAT WAS OUR 1 SERIES.
MR. DOWNEY: AND AT THAT TIME, DID THERANOS ENCOUNTER A SIGNIFICANT CHALLENGE WITH REGARD TO ITS TECHNOLOGY?
MR. DOWNEY: WHAT HAPPENED?
ELIZABETH A. HOLMES: THE WAY WE BUILT THE CARTRIDGES FOR OUR 1 SERIES DEVICE REQUIRED US TO PUT TOGETHER MANY LAYERS OF THE CARTRIDGE. THEY WERE HELD TOGETHER WITH WHAT WAS CALLED AN ADHESIVE, IT'S KIND OF LIKE A GLUE, AND WHEN EXPOSED TO CERTAIN PRESSURE, THOSE LAYERS WOULD LOOSEN, WHICH MEANT THAT IF WE WERE GOING TO BE SHIPPING THESE CARTRIDGES ALL OVER THE PLACE, WE HAD A PROBLEM.
MR. DOWNEY: WHAT DID YOU DO IN RESPONSE TO THAT PROBLEM?
ELIZABETH A. HOLMES: WE WENT BACK TO THE TABLE WITH OUR ENGINEERS AND SCIENTISTS AND TRIED TO FIGURE OUT HOW TO FIX IT.
MR. DOWNEY: AND WERE YOU ABLE TO DEVELOP A SOLUTION ULTIMATELY TO THAT PROBLEM?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: TELL US ABOUT THE PROCESS YOU WENT THROUGH TO CORRECT THE PROBLEM.
ELIZABETH A. HOLMES: WE LOOKED AT EVERY OPTION WE COULD THINK OF. WE HAD REALLY THE WHOLE COMPANY WORKING ON DIFFERENT WAYS TO APPROACH IT. ULTIMATELY, WE DECIDED INSTEAD OF TRYING TO DO THE HANDLING OF REALLY SMALL VOLUMES OF LIQUID THE WAY THAT WE WERE WITH THAT CARTRIDGE DESIGN, WE WOULD MOVE TO A DIFFERENT DESIGN IN OUR NEXT ITERATION OF THE PRODUCT.
MR. DOWNEY: AND WHEN YOU SAY YOUR NEXT ITERATION OF THE PRODUCT, DO YOU MEAN WITH RESPECT TO THE ANALYZER DEVICES AND THE CARTRIDGES, OR WITH REGARD TO SOMETHING ELSE?
ELIZABETH A. HOLMES: WITH RESPECT TO THE ANALYZER DEVICES AND THE CARTRIDGES.
MR. DOWNEY: AND DID THE CHALLENGE THAT YOU FACED AT THIS TIME, DID IT HAVE ANYTHING TO DO WITH THERANOS'S ASSAYS?
MR. DOWNEY: DID IT HAVE ANYTHING TO DO WITH THERANOS'S DEVELOPMENT OF SOFTWARE AT THAT TIME?
MR. DOWNEY: I'D LIKE TO ASK YOU, IS THE DEVICE THAT YOU ULTIMATELY DESIGNED IN REACTION TO THIS PROBLEM THE THERANOS 3.0 DEVICE?
MR. DOWNEY: AND IS THAT THE DEVICE THAT THERANOS ULTIMATELY USED IN CONNECTION WITH MANY OF ITS PARTNERSHIPS WITH PHARMACEUTICAL COMPANIES?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: I'D LIKE YOU TO TAKE US THROUGH HOW THE DESIGN CHANGED AND WHAT MODIFICATIONS WERE MADE FOR THAT DEVICE, BECAUSE WE'RE GOING TO BE TALKING ABOUT PHARMACEUTICAL COMPANIES IN A MINUTE. LET ME ASK YOU FIRST IF YOU CAN IDENTIFY EXHIBIT 15010?
ELIZABETH A. HOLMES: 15010. I DON'T SEE IT.
MR. DOWNEY: YOU DON'T HAVE THAT IN YOUR NOTEBOOK?
ELIZABETH A. HOLMES: OH, I DO. YES, I'M SORRY. I DO.
MR. DOWNEY: AND WHAT IS 15010 A PHOTOGRAPH OF?
ELIZABETH A. HOLMES: 15010 IS A PHOTOGRAPH OF A TECAN ROBOT.
MR. DOWNEY: AND IF YOU CAN LOOK NEXT AT THE NEXT EXHIBIT, 15011, WHAT IS 15011?
ELIZABETH A. HOLMES: 15011 IS A PICTURE OF THE INSIDE OF ONE OF OUR EARLY 3 SERIES DEVICES.
MR. DOWNEY: SO THIS IS A 3.0 THERANOS DEVICE?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: IS IT WITH THE COVER TAKEN OFF?
MR. DOWNEY: OKAY.
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15010 AND 15011.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: THEY'RE RECEIVED. THEY MAY BE PUBLISHED.
(DEFENDANT'S EXHIBITS 15010 AND 15011 WERE RECEIVED IN EVIDENCE.)
MR. DOWNEY: CAN I ASK WHEN YOU PUBLISH THEM TO PUT THEM UP ON A SIDE-BY-SIDE BASIS.
MR. DOWNEY: NOW, THE DEVICE THAT WE SEE ON THE LEFT, WAS THAT A THERANOS DEVICE?
MR. DOWNEY: WHO MANUFACTURES THAT DEVICE?
ELIZABETH A. HOLMES: A COMPANY CALLED TECAN.
MR. DOWNEY: OKAY. AND EXPLAIN WHAT THE RELATIONSHIP IS BETWEEN TECAN'S DEVICE ON THE LEFT-HAND SIDE AND THE THERANOS 3.0 DEVICE THAT WE SEE ON THE RIGHT-HAND SIDE OF THE DISPLAY?
ELIZABETH A. HOLMES: WE HAD BEEN DEVELOPING AND RUNNING OUR SMALL SAMPLE CHEMISTRIES ON THESE BIG TECAN DEVICES FOR SOME TIME AT THIS POINT. AND AS WE WERE THINKING ABOUT HOW TO ITERATE THE DEVICE, WE REALIZED THAT IF WE COULD MINIATURIZE THE ROBOT ON THE TECAN ITSELF, WE COULD RUN THOSE CHEMISTRIES IN THE DEVICE THE SAME WAY WE HAD BEEN IN THE LAB AND WE COULD DEAL WITH THE ISSUE OF HAVING TO HAVE A CARTRIDGE THAT HAD A LOT OF LAYERS BECAUSE NOW WE COULD BUILD A CARTRIDGE THAT JUST HAD MINIATURIZED WELLS AND LITTLE VESSELS TO MOVE FLUID AROUND INSTEAD OF HAVING TO FLOW FLUID THROUGH A CHANNEL.
MR. DOWNEY: AND COULD YOU SHOW US IN EXHIBIT 15011 HOW THIS THERANOS 3.0 DEVICE WAS DESIGNED TO WORK?
ELIZABETH A. HOLMES: YES. SO HERE WE GO. SO INSIDE OF THE DEVICE WHEN WE WERE LOOKING AT THE TECAN ROBOT HERE ON THE LEFT, THIS IS WHAT IS CALLED THE LIQUID HANDLING ROBOT. THIS IS A ROBOT THAT CAN BE PROGRAMMED TO PERFORM ANY PROTOCOL OR SET OF INSTRUCTIONS BASED ON WHAT TEST YOU WANT TO RUN. WE PUT A SMALL LIQUID HANDLING ROBOT INTO THE PIPET -- INTO THE DEVICE HERE ON THE RIGHT, SOMETIMES CALLS A PIPET, AND HAD A CARTRIDGE THAT COULD MIMIC THE PLATES, THE BIG PLATES THAT ARE HERE ON THE LEFT IN A MINIATURIZED CONTEXT INSIDE OF THE DEVICE. WE THEN MOUNTED A DETECTOR FOR MEASUREMENT OF THE CHEMICALS THAT REACT INSIDE THE CARTRIDGE BEHIND THE LIQUID HANDLING ROBOT. AND THE WAY THE 3 SERIES WOULD WORK IS THAT THE PIPET COULD PICK UP LITTLE TIPS AND VESSELS THAT ARE INSIDE THE CARTRIDGE, ALLOW FOR THOSE CHEMICALS TO BE MIXED TOGETHER, MOVE THEM TO THIS DETECTOR IN THE BACK, AND READ THEM OUT TRANSMITTING THE DATA TO THE CLOUD.
MR. DOWNEY: NOW, IS THE DEVICE THAT IS DEPICTED HERE, IS THAT A PROTOTYPE, OR IS THAT THE ACTUAL DEVICE?
ELIZABETH A. HOLMES: THIS WAS AN ACTUAL DEVICE.
MR. DOWNEY: HOW LONG DID IT TAKE TO GO FROM THE PROBLEMS THAT YOU REALIZED YOU HAD AROUND THE TIME OF THE NOVARTIS DEMONSTRATION UNTIL YOU HAD A FINISHED 3.0 DEVICE?
ELIZABETH A. HOLMES: IT WAS WITHIN ABOUT A YEAR.
MR. DOWNEY: OKAY. AND WHILE YOU WERE DOING THAT, DID YOU CONTINUE TO WORK ON DEVELOPING SMALL SAMPLE ASSAYS?
MR. DOWNEY: AND DID THE COMPANY CONTINUE TO WORK ON DEVELOPING ITS SOFTWARE?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: WHO WAS LEADING THE COMPANY'S DEVELOPMENT OF ASSAYS DURING THE PERIOD YOU WERE WORKING TO DEVELOP THE 3.0 DEVICE?
ELIZABETH A. HOLMES: DR. IAN GIBBONS AND GARY FRENZEL.
MR. DOWNEY: NOW, WHEN WOULD YOU SAY THE 3 SERIES DEVICE WAS FINALIZED AND ACTUALLY A PRODUCT THAT THERANOS COULD OFFER?
ELIZABETH A. HOLMES: BY THE END OF 2007 OR SO.
MR. DOWNEY: OKAY. AND AT THAT TIME, DID YOU -- HAD YOU BEGUN TO FORM AN UNDERSTANDING OF THE BENEFITS OF THERANOS TECHNOLOGY RELATIVE TO TRADITIONAL BLOOD TESTING TECHNOLOGY?
MR. DOWNEY: AND CAN YOU TELL US ABOUT SOME OF THOSE ADVANTAGES AS YOU UNDERSTOOD THEM? DID YOU CONSIDER THE PERFORMANCE -- THE 3.0 DEVICE TO COMPARE FAVORABLY OR UNFAVORABLY WITH REGARD TO TRADITIONAL SYSTEMS IN TERMS OF THE ABILITY TO ELIMINATE HUMAN INTERVENTION IN THE PROCESS?
MR. LEACH: LEADING, YOUR HONOR.
JUDGE DAVILA: WELL, IT WAS LEADING. BUT DID YOU UNDERSTAND THE QUESTION?
ELIZABETH A. HOLMES: I DO.
BY MR. DOWNEY:
MR. DOWNEY: HOW DO YOU THINK IT AFFECTS --
JUDGE DAVILA: ARE YOU GOING TO WITHDRAW THAT QUESTION?
MR. DOWNEY: I WILL WITHDRAW IT.
JUDGE DAVILA: AND DO YOU WANT TO ASK ANOTHER QUESTION?
MR. DOWNEY: I DON'T WANT TO HAVE ANY CONTROVERSY ABOUT THIS.
MR. DOWNEY: WHAT EFFECT DID YOU THINK THAT THIS HAD ON THE USE OF AUTOMATION IN CONDUCTING BLOOD TESTING?
ELIZABETH A. HOLMES: WE THOUGHT THIS WAS A REALLY BIG IDEA BECAUSE THESE ROBOTS THAT ARE USED IN THE TRADITIONAL LAB HAD NOT, AS FAR AS WE KNOW, BEEN MINIATURIZED TO RUN IN A DEVICE THAT COULD BE PUT AT THE POINT OF CARE, AND THAT MEANT TWO THINGS. ONE, THAT THE HUMAN PROCESSING THAT IS OFTEN REQUIRED WITH TESTING WOULD NOT BE REQUIRED IN THE SAME WAY WITH THIS DEVICE AND THAT TESTING IS A SOURCE OF A HUGE AMOUNT OF THE ERROR IN TRADITIONAL LAB TESTING. IT ALSO MEANT THAT WE HAD A DEVICE THAT COULD BE PROGRAMMED TO RUN ANY PROTOCOL THAT WE DEVELOPED IN THE LAB, WHICH MEANT NOW, UNLIKE A GLUCOSE METER, WE DID NOT HAVE TO BE RESTRICTED TO JUST ONE TEST THAT COULD RUN ON THE DEVICE.
MR. DOWNEY: LET ME SHOW YOU EXHIBIT 7161 AND ASK IF YOU CAN IDENTIFY THAT EXHIBIT. IT SHOULD BE IN THAT SAME BOOK.
MR. DOWNEY: AND WHAT IS EXHIBIT 7161? IS THIS AN EMAIL THAT -- IS THAT AN EMAIL THAT YOU EXCHANGED WITH INDIVIDUALS AT THERANOS ABOUT THE TECHNOLOGY AND ERROR RATES WITH RESPECT TO THE TECHNOLOGY?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 7161.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7161 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: LET ME SHOW YOU THE TOP OF THE EMAIL. THIS APPEARS TO BE AN EMAIL FROM SOMEONE NAMED TONY NUGENT TO YOU IN 2011; IS THAT RIGHT?
MR. DOWNEY: AND THAT'S A LITTLE LATER THAN THE PERIOD THAT WE'RE TALKING ABOUT?
ELIZABETH A. HOLMES: IT IS, YES.
MR. DOWNEY: IF YOU LOOK AT THE BODY OF THE EMAIL, CAN YOU HELP US UNDERSTAND WHAT THIS EMAIL CONVEYED TO YOU AROUND THE TIME THAT YOU RECEIVED IT IN 2011?
ELIZABETH A. HOLMES: YES. CAN I TAKE A MINUTE JUST TO LOOK AND READ IT?
MR. DOWNEY: SURE. AND JUST FOR YOUR ATTENTION, I'M INTERESTED IN FOCUSSING REALLY ON THE PART OF THE DISCUSSION THAT IS ON THE SIXTH OR THE SEVENTH LINE OF THE EMAIL, THERE'S A SENTENCE THAT BEGINS, "ACCORDINGLY." DO YOU SEE THAT SENTENCE? WHY DON'T YOU TAKE A MOMENT AND REVIEW THAT AND THEN I'LL ASK YOU THE QUESTION.
MR. DOWNEY: SO IS THIS AN EXCERPT FROM A PROFESSIONAL JOURNAL THAT WAS FORWARDED TO YOU?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: AND DO YOU SEE THERE'S A SENTENCE THAT READS, "ACCORDINGLY, LACK OF STANDARDIZED PROCEDURES FOR SAMPLE COLLECTION, INCLUDING PATIENT PREPARATION, SPECIMEN ACQUISITION, HANDLING AND STORAGE, ACCOUNT FOR UP TO 93 PERCENT OF THE ERRORS CURRENTLY ENCOUNTERED WITHIN THE ENTIRE DIAGNOSTIC PROCESS."
MR. DOWNEY: AND WHAT DID YOU UNDERSTAND THAT TO MEAN AT THE TIME THAT YOU RECEIVED THIS IN 2011?
ELIZABETH A. HOLMES: I UNDERSTOOD THAT THIS WAS SAYING THAT THE MAJORITY OF ERROR THAT HAPPENS IN THE LAB TESTING PROCESS HAPPENS IN WHAT THEY'RE CALLING PREANALYTICAL PROCESSING OF SAMPLES. SO THIS IS BEFORE THE ANALYSIS IS EVEN DONE, AND THAT MEANT IF WE HAD THE ABILITY TO AUTOMATE MUCH OF THAT PROCESS, WE COULD REDUCE THE ERROR ASSOCIATED WITH TRADITIONAL LAB TESTING.
MR. DOWNEY: AND WITH THIS 3.0 SYSTEM, DID THERE COME A TIME WHEN THERANOS BEGAN TO TRY TO WORK AGAIN WITH PHARMACEUTICAL COMPANIES?
MR. DOWNEY: AND LET ME SHOW YOU AN EMAIL THAT IS MARKED AT 15022.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: IS 15022 AN EMAIL THAT WAS SENT TO YOU BY SOME SCIENTISTS AT THERANOS REGARDING THE THERANOS SYSTEM IN 2008?
MR. DOWNEY: I MOVE THE ADMISSION OF 15022.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15022 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: PRIOR TO -- OR STRIKE THAT. AROUND THE TIME THAT THERANOS WAS WORKING WITH PHARMACEUTICAL COMPANIES, DID YOU TAKE -- UNDERTAKE EFFORTS TO TRY TO UNDERSTAND THE BENEFITS OF THE SYSTEM DESIGN IN CONNECTION WITH PHARMACEUTICAL TRIALS AND OTHER APPLICATIONS?
MR. DOWNEY: AND WHY DID YOU DO THAT?
ELIZABETH A. HOLMES: I'M SORRY. DID YOU SAY WHY?
MR. DOWNEY: WHY?
ELIZABETH A. HOLMES: BECAUSE WE BELIEVED THAT OUR PRODUCT COULD BE USED BY PHARMACEUTICAL COMPANIES TO HELP GET BETTER INSIGHT INTO HOW A DRUG WOULD WORK, AND TO HELP SPEED THE AMOUNT OF TIME THAT IT WOULD TAKE TO RUN A STUDY.
MR. DOWNEY: OKAY. LET'S LOOK AT THE SECOND PAGE OF THIS EXHIBIT. IS THIS A POWERPOINT FOR A PRESENTATION THAT YOU GOT FROM MR. GIBBONS?
MR. DOWNEY: LET ME ASK YOU TO FLIP TO THE NEXT PAGE. I WANT TO ASK YOU SOME QUESTIONS ABOUT THE DISCUSSION ON THIS SLIDE. GENERALLY, AFTER YOU HAVE AN OPPORTUNITY TO LOOK THROUGH IT, LET ME ASK YOU, IS THIS A DESCRIPTION OF THE FEATURES OF THE SYSTEM AND ITS RELEVANT BENEFITS?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: THERE'S A BULLET POINT AT THE TOP THAT SAYS "MULTIPLEXED MEASUREMENT OF BIOMARKERS." WHAT IS MULTIPLEXED MEASUREMENT?
ELIZABETH A. HOLMES: IT MEANS THAT MULTIPLE TESTS COULD BE RUN AT THE SAME TIME ON A SINGLE CARTRIDGE, ON A SINGLE DEVICE.
MR. DOWNEY: AND THE NEXT ENTRY SAYS "SERIAL MEASUREMENT." WHAT DOES THAT MEAN?
ELIZABETH A. HOLMES: IT'S REFERRING TO THE FACT THAT SINCE WE HAD SUCH A SMALL SAMPLE, WE COULD TAKE MORE SAMPLES FROM SOMEONE OVER TIME, WHICH WOULD ALLOW US TO SEE HOW THINGS IN THEIR BLOOD WERE CHANGING.
MR. DOWNEY: AND IS THAT WHY A SMALL SAMPLE SIZE IS REFERENCED A FEW ENTRIES DOWN?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: OKAY. LET ME ASK YOU TO SKIP ABOUT THREE LINES DOWN FROM THE SMALL SAMPLE SIZE AND DIRECT YOUR ATTENTION TO HIGH SENSITIVITY?
MR. DOWNEY: IS THIS A FEATURE OF THE SYSTEM THAT IS BEING EXPLAINED TO YOU BY DR. GIBBONS AT THIS TIME?
MR. DOWNEY: AND WHAT DOES HIGH SENSITIVITY MEAN TO YOUR UNDERSTANDING?
ELIZABETH A. HOLMES: IT MEANS THAT IF SOMETHING IS PRESENT IN THE BLOOD AT A REALLY, REALLY LOW CONCENTRATION, WE COULD MEASURE IT, AND WE COULD DO THAT AT THIS REALLY LOW LEVEL OF 0.2 PICOGRAMS PER MIL.
MR. DOWNEY: AND IF YOU GO DOWN A FEW MORE LINES, THERE'S A REFERENCE TO FACTORY CALIBRATION. DO YOU SEE THAT?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND WHAT DOES FACTORY CALIBRATION MEAN?
ELIZABETH A. HOLMES: THIS IS TALKING ABOUT THE FACT THAT WE WERE BUILDING DEVICES TO BE USED IN THE FIELD, AND ONE OF OUR INVENTIONS WAS AROUND HOW WE WOULD CALIBRATE THOSE DEVICES TO BE THE SAME AS EACH OTHER. SO IF WE DEPLOYED A DEVICE IN ONE STATE AND ANOTHER DEVICE IN THE OTHER STATE, THE DEVICES THEMSELVES WERE DESIGNED TO BE EQUIVALENT. AND THAT'S DIFFERENT THAN IF YOU MADE A BIG MACHINE FOR THE TRADITIONAL LAB, GENERALLY THOSE DEVICES ARE NOT CALIBRATED TO EACH OTHER, SO A BIG MACHINE IN A TRADITIONAL LAB IN PALO ALTO MIGHT BE DIFFERENT THAN A BIG MACHINE IN A TRADITIONAL LAB IN SAN FRANCISCO.
MR. DOWNEY: OKAY. THE LAST ITEM REFERS TO PROPRIETARY ALGORITHMS. WHY IS THAT BEING DESCRIBED AS A FEATURE OF THE THERANOS SYSTEM DESIGN?
ELIZABETH A. HOLMES: ONE OF THE KEY PARTS OF OUR SYSTEM WAS THE SOFTWARE AND THE DATA PART, AND WHAT WE WERE TRYING TO DO WAS HELP PEOPLE UNDERSTAND WHERE THEY WERE HEADED WITH THEIR HEALTH BASED ON THEIR LAB RESULTS, AND THAT'S WHAT THE ALGORITHM IS TALKING ABOUT.
MR. DOWNEY: OKAY. LET ME ASK YOU TO MOVE TOWARDS THE END OF THIS PRESENTATION TO PAGE 14, A PAGE THAT IS LABELLED CONCLUSIONS. MAYBE WE CAN BRING IT UP HERE. I'D LIKE YOU TO JUST TAKE US THROUGH THE BULLET POINTS ON EXHIBIT 15022, AND HELP US UNDERSTAND THE CONCLUSIONS THAT WERE BEING PRESENTED TO YOU AT THIS TIME. DID, DID YOU -- WERE YOU PRESENTED WITH THE CONCLUSION THAT PERFORMANCE DESIGN GOALS OF THE SYSTEM HAVE BEEN DEMONSTRATED?
MR. DOWNEY: AND WHAT DID THAT MEAN?
ELIZABETH A. HOLMES: THAT MEANT THAT THOSE DESIGN FEATURES THAT WE WERE TALKING ABOUT ON THE EARLIER PAGE HAD BEEN DEMONSTRATED.
MR. DOWNEY: OKAY. THE SECOND BULLET POINT SAYS, "THE SYSTEM IS NOW IN CLINICAL EVALUATION." THIS IS AS OF 2008 IN THE MIDDLE OF THE YEAR. WHAT DID THAT MEAN?
ELIZABETH A. HOLMES: THAT MEANT THAT WE HAD SHIPPED THE SYSTEM TO SEVERAL DIFFERENT SITES TO BE USED IN CLINICAL PROGRAMS FOR EVALUATION.
MR. DOWNEY: OKAY. AND YOU WERE TOLD THAT THE CLINICAL EVALUATION RESULTS HAD BEEN EXCELLENT; IS THAT RIGHT?
ELIZABETH A. HOLMES: I WAS.
MR. DOWNEY: AND THEN THE LAST ENTRY REFERS TO THE SCALE-UP AND GMP DOCUMENTATION AND 510K SUBMISSIONS ARE IN HAND. LET ME BREAK THAT DOWN A LITTLE BIT. WHAT DOES SCALE-UP MEAN?
ELIZABETH A. HOLMES: SCALE-UP MEANS GROWING, MAKING MORE OF THESE DEVICES, CARTRIDGES, CHEMISTRY, AND GETTING THE SOFTWARE SYSTEM REALLY ROBUST.
MR. DOWNEY: AND THEN THERE'S A REFERENCE TO GMP DOCUMENTATION. WHAT DOES THAT MEAN?
ELIZABETH A. HOLMES: THAT IS THE DOCUMENTATION THAT IS USED FOR MANUFACTURING TO ENSURE THAT WE'RE MAKING THE DEVICES THE RIGHT WAY AND THAT WE HAVE GOOD QUALITY SYSTEMS OVERSEEING THAT PROCESS.
MR. DOWNEY: OKAY. AND THERE'S A REFERENCE TO 510K SUBMISSIONS. WHAT ARE 510K SUBMISSIONS?
ELIZABETH A. HOLMES: FDA SUBMISSIONS.
MR. DOWNEY: OKAY. WHAT, IF ANYTHING, DID YOU TAKE AWAY FROM DR. GIBBONS'S PRESENTATION?
ELIZABETH A. HOLMES: I TOOK AWAY THAT WE WERE HITTING THE DESIGN GOALS FOR THIS SYSTEM AND THAT THE SYSTEM WAS PERFORMING IN A WAY THAT WAS EXCELLENT IN CLINICAL SITES.
MR. DOWNEY: AND IN 2008 AND 2009, DID THERANOS MAKE EFFORTS TO TRY TO USE ITS 3.0 SYSTEM IN CONNECTION WITH OPPORTUNITIES IN CONNECTION WITH THE DEPARTMENT OF DEFENSE?
MR. DOWNEY: AND DID IT ATTEMPT TO USE ITS 3.0 DEVICE IN CONNECTION WITH RESEARCH STUDIES AT STANFORD UNIVERSITY?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND DID, DID THERANOS USE ITS 3.0 DEVICE TO WORK WITH PHARMACEUTICAL COMPANIES IN THAT PERIOD?
MR. DOWNEY: LET'S START WITH THE DEPARTMENT OF DEFENSE. WHAT PROGRAMS DID THERANOS ATTEMPT TO PARTNER WITH THE DEPARTMENT OF DEFENSE ON IN 2008 AND 2009?
ELIZABETH A. HOLMES: THERE WERE SEVERAL. ONE WAS SEEING WHETHER THERE WERE MARKERS IN THE BLOOD THAT COULD PREDICT PTSD. ANOTHER WAS ASSOCIATED WITH DIABETES MANAGEMENT. ANOTHER WAS DEALING WITH INFECTION IN TRAUMA PATIENTS AND SEEING IF YOU COULD BETTER PREDICT WHEN THAT INFECTION HIT THE BLOODSTREAM AND PEOPLE WERE GOING TO GET REALLY SICK.
MR. DOWNEY: WELL, LET'S TAKE A STEP BACK. WHAT PART OF DOD DID THERANOS ATTEMPT TO PARTNER WITH TO PERFORM THE RESEARCH THAT YOU'VE JUST DESCRIBED?
ELIZABETH A. HOLMES: AN ORGANIZATION CALLED TATRC.
MR. DOWNEY: AND IN CONNECTION WITH THE PROGRAMS THAT YOU'VE JUST DESCRIBED, WERE THEY TO BE RESEARCH STUDIES IN CONNECTION WITH TATRC?
MR. DOWNEY: AND CAN YOU, CAN YOU SPELL TATRC?
ELIZABETH A. HOLMES: T-A -- I'M SORRY. T-A-T-R-C.
MR. DOWNEY: WAS THERANOS SUCCESSFUL IN FORMING A PARTNERSHIP WITH TATRC IN 2008 AND 2009?
MR. DOWNEY: DID YOU MET ANY PERSONNEL FROM THE DEPARTMENT OF DEFENSE WITH WHOM THERANOS WOULD LATER WORK IN CONNECTION WITH THOSE EFFORTS TO PARTNER IN 2008 AND 2009?
MR. DOWNEY: WHO DID YOU MEET?
ELIZABETH A. HOLMES: WE MET COLONEL CHUNG AT THE INSTITUTE FOR SURGICAL RESEARCH FOR THE ARMY.
MR. DOWNEY: AND WHO WAS COLONEL CHUNG?
ELIZABETH A. HOLMES: HE WAS A PHYSICIAN WHO WAS OVERSEEING A NUMBER OF RESEARCH PROGRAMS IN TEXAS.
MR. DOWNEY: AND DID THERANOS PARTNER WITH RESEARCHERS AT STANFORD UNIVERSITY TO PERFORM A STUDY ON SEPSIS IN 2008 AND 2009?
MR. DOWNEY: LET ME SHOW YOU EXHIBIT 12065.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: CAN YOU IDENTIFY 12065?
ELIZABETH A. HOLMES: YES. THIS IS ANOTHER UPDATE FROM DR. GIBBONS ABOUT THE PERFORMANCE OF OUR TECHNOLOGY IN CLINICAL STUDIES.
MR. DOWNEY: AND WAS THIS PRESENTATION GIVEN AROUND JUNE OF 2008?
MR. DOWNEY: LET ME ASK YOU TO LOOK AT THE SECOND PAGE OF THE EXHIBIT. WELL, IT MIGHT BE EASIER TO DO ON THE SCREEN. YOUR HONOR, CAN WE ADMIT EXHIBIT 12065?
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 12065 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: LET ME ASK YOU TO GO TO THE SECOND AND THIRD PAGES. SO THIS IS A REPORT ON THERANOS CLINICAL STUDY?
MR. DOWNEY: AND IF YOU GO TO THE NEXT PAGE, THERE'S A REFERENCE TO THE STANFORD AML STUDY. WHAT IS THAT A REFERENCE TO?
ELIZABETH A. HOLMES: THAT IS A STUDY WE WERE RUNNING WITH STANFORD ON AML PATIENTS. THESE ARE CANCER PATIENTS.
MR. DOWNEY: OKAY. AND LET ME ASK YOU TO LOOK AT THE SEVENTH PAGE OF THE EXHIBIT, AND DO YOU SEE WHERE IT'S LABELLED "STUDY DESIGN" ON PAGE 6 OF THE SLIDE, PAGE 7 OF THE EXHIBIT?
MR. DOWNEY: AND IS THIS A DESCRIPTION OF, OF THE STEPS THAT WERE TAKEN IN CONNECTION WITH THE STUDY?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: AND CAN YOU, CAN YOU TELL US HOW THE STUDY WAS DESIGNED TO WORK?
ELIZABETH A. HOLMES: THE STUDY WAS DESIGNED SUCH THAT SAMPLES THAT WERE COLLECTED FROM THESE PATIENTS WERE SHIPPED TO THERANOS AND RUN ON THERANOS DEVICES, AND DATA WAS PROVIDED BACK TO STANFORD.
MR. DOWNEY: AND THERE'S A REFERENCE TO CLINICAL INFORMATION BEING COLLECTED AT THE BOTTOM OF THE PAGE. DO YOU SEE THAT?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND CAN YOU JUST GIVE US A SENSE OF THE CLINICAL CONDITIONS THAT WERE BEING STUDIED AND WHY IT WAS IMPORTANT TO STUDY THEM?
ELIZABETH A. HOLMES: YES. THESE PATIENTS WERE VERY SICK AND THEIR IMMUNE SYSTEMS WEREN'T WORKING WELL ANYMORE, AND SO THERE WAS A REALLY HIGH RISK THAT THEY COULD GET INFECTED. WE WERE MEASURING THEIR BLOOD TRYING TO PREDICT WHEN THAT WOULD HAPPEN SO THAT THEY COULD GET ANTIBIOTIC OR OTHER TREATMENT EARLIER IN THE FUTURE IF TESTS LIKE THIS COULD BE MADE AVAILABLE.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT PAGE 23, SLIDE 22. AND ARE THESE THE CONCLUSIONS OF THE STUDY?
MR. DOWNEY: IF YOU'LL LOOK AT THE FIRST BULLET POINT, IT SAYS, "VERY CLEAR PATTERNS OF DISEASE PROGRESSION, REMISSION AND EFFECTS OF THERAPIES ARE APPARENT." CAN YOU EXPLAIN WHAT THAT MEANS?
ELIZABETH A. HOLMES: YES. WHAT DR. GIBBONS IS SAYING IS THAT BASED ON THE FREQUENCY OF SAMPLES THAT WE COULD GET, WE'RE ACTUALLY SEEING PATTERNS THAT SHOW THE DISEASE PROGRESSING, SHOW IT REGRESSING, AND SHOW HOW THERAPIES ARE WORKING ON PATIENTS.
MR. DOWNEY: AND IF YOU'LL LOOK AT THE SECOND BULLET POINT, WHICH BEGINS "GOOD CORRELATIONS," CAN YOU EXPLAIN THAT?
ELIZABETH A. HOLMES: YES. HE'S SAYING THAT THESE TRENDS IN THE BLOOD DATA ARE CORRELATING WITH WHAT IS ACTUALLY HAPPENING TO THE PATIENTS.
MR. DOWNEY: OKAY. AND IF YOU GO -- SKIP THE NEXT BULLET POINT. THERE'S A REFERENCE IN THE FOURTH BULLET POINT TO ASSAY RESULTS AND IT MENTIONS HOW PRECISE THEY ARE. TELL US THE SIGNIFICANCE OF THAT FROM YOUR PERSPECTIVE AT THIS TIME.
ELIZABETH A. HOLMES: IT MEANT OUR SYSTEM WAS WORKING WELL.
MR. DOWNEY: AND, AND WHEN IT SAYS ASSAY RESULTS HAVE BEEN PRECISE, WHAT EXACTLY DID IT MEAN?
ELIZABETH A. HOLMES: IT MEANT THAT OUR SCIENTISTS WERE LOOKING AT THE DATA FROM THE STUDY AND EVALUATING HOW PRECISE THEY WERE TO ASSESS HOW GOOD THE SYSTEM WAS.
MR. DOWNEY: OKAY. AT THIS TIME IT LOOKS LIKE FROM THIS PRESENTATION THE STUDY WAS ABOUT TWO-THIRDS COMPLETE; IS THAT RIGHT?
MR. DOWNEY: AND WAS THE STUDY CONCLUDED?
MR. DOWNEY: AND WERE THE RESULTS OF THE STUDY ULTIMATELY PUBLISHED IN A CLINICAL JOURNAL?
MR. DOWNEY: LET ME ASK YOU TO LOOK AT EXHIBIT 15002. AND I'LL ASK IF YOU CAN IDENTIFY THAT?
ELIZABETH A. HOLMES: YES. THIS IS THE PEER REVIEWED PAPER PUBLISHING THE RESULTS OF THE STUDY.
MR. DOWNEY: OKAY. AND IF YOU WOULD LOOK AT THE SECOND PAGE OF THAT EXHIBIT, I'M SORRY, THE FIRST PAGE OF THAT EXHIBIT. DO YOU SEE IN THE MIDDLE COLUMN THE REFERENCE TO JUST THE SENTENCE, WITHOUT DESCRIBING IT, IT SAYS A COMMON LIMITATION?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15002.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15002 WAS RECEIVED IN EVIDENCE.)
MR. DOWNEY: AND LET ME ASK TO DISPLAY THE LANGUAGE IN THE MIDDLE COLUMN THAT SAYS "A COMMON LIMITATION."
MR. DOWNEY: DO YOU SEE A REFERENCE THERE TO THE LOW FREQUENCY OF MEASUREMENT?
MR. DOWNEY: WHAT DOES LOW FREQUENCY OF MEASUREMENT REFER TO IN THIS ARTICLE?
ELIZABETH A. HOLMES: IT MEANS THAT IF YOU CAN'T TAKE A LOT OF BLOOD OUT OF SOMEONE, AND THEREFORE, YOU DON'T GET A LOT OF SAMPLES OVER TIME, YOU, YOU DON'T HAVE A TIME SERIES.
MR. DOWNEY: AND IN PART, WAS THIS STUDY DESIGNED TO SEE WHAT EFFECT THERANOS'S ABILITY TO TAKE SMALL SAMPLES WOULD HAVE ON THE ABILITY TO GET MEASUREMENTS?
MR. DOWNEY: AND WHAT WERE THE RESULTS OF THE STUDY IN TERMS OF WHAT THE EFFECTS WERE OF EARLIER INTERVENTION ON PATIENTS WHO WERE AT RISK OF INFECTION?
ELIZABETH A. HOLMES: THE STUDY SHOWED SOME PRELIMINARY TRENDS INDICATING THAT IF YOU COULD TAKE SAMPLES FREQUENTLY, YOU MIGHT ACTUALLY BE ABLE TO PREDICT SEPSIS USING THESE KIND OF MARKERS. BUT THERE WAS A VERY SMALL NUMBER OF PEOPLE IN THE STUDY, AND MORE STUDIES WERE NEEDED.
MR. DOWNEY: DID THE STUDY REACH ANY CONCLUSIONS WITH REGARD TO THE QUALITY OF THERANOS'S TECHNOLOGY?
ELIZABETH A. HOLMES: I'M, I'M NOT SURE.
MR. DOWNEY: OKAY.
ELIZABETH A. HOLMES: I THINK SO, YES.
MR. DOWNEY: BUT YOU'RE NOT CERTAIN AT THIS STAGE MANY YEARS LATER?
ELIZABETH A. HOLMES: I REMEMBER DR. GIBBONS TALKING ABOUT THE FACT THAT THE RESULTS WERE PRECISE, BUT I'M NOT SURE WHAT WAS IN THIS PAPER.
MR. DOWNEY: OKAY. FAIR ENOUGH.
MR. LEACH: YOUR HONOR.
JUDGE DAVILA: EXCUSE ME, MR. DOWNEY.
MR. LEACH: HEARSAY. I DON'T MIND THAT LAST ANSWER COMING IN FOR THE STATE OF MIND, BUT TALKING ABOUT WHAT DR. GIBBONS THOUGHT IS HEARSAY.
MR. DOWNEY: I THINK IT CERTAINLY GOES TO STATE OF MIND.
JUDGE DAVILA: IT'S ADMITTED. THAT'S FINE. YOU CAN ASK ANOTHER QUESTION.
BY MR. DOWNEY:
MR. DOWNEY: IN ADDITION TO THE DEPARTMENT OF DEFENSE AND TO WHAT WE'VE BEEN TALKING ABOUT WITH REGARD TO ACADEMIC RESEARCH STUDIES, DID THERANOS BEGIN TO PARTNER WITH A LARGE NUMBER OF PHARMACEUTICAL COMPANIES IN 2008 AND 2009?
MR. DOWNEY: LET ME SHOW YOU EXHIBIT 7742. DO YOU RECOGNIZE EXHIBIT 7742?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND WHAT IS 7742?
ELIZABETH A. HOLMES: IT WAS ONE OF THE UPDATES THAT I GOT ON THE STUDIES THAT THERANOS HAD COMPLETED AT THAT POINT IN TIME.
MR. DOWNEY: AND WERE THESE SPECIFICALLY STUDIES RELATED TO PHARMACEUTICAL COMPANIES' WORK?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 7742.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7742 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: LET'S LOOK AT THE TOP OF THE EMAIL. IT SEEMS TO BE THERE'S AN EMAIL EXCHANGE THAT -- WHERE YOU'RE THE ADDRESSEE AND IT'S SENT BY STEFAN HRISTU. WHO WAS STEFAN HRISTU?
ELIZABETH A. HOLMES: STEFAN WAS IN THE TEAM WE CALLED CLIENT SOLUTIONS, WHICH DID PRODUCT AND PRODUCT MANAGEMENT.
MR. DOWNEY: AND IT'S COPIED TO A PERSON NAMED CAROLYN BALKENHOL. WHO WAS CAROLYN BALKENHOL?
ELIZABETH A. HOLMES: CAROLYN BALKENHOL WAS MY ASSISTANT AND WORKED WITH ME ON A NUMBER OF PROJECTS.
MR. DOWNEY: AND IF YOU GO TO THE NEXT PAGE, THERE'S A QUESTION, WHICH IS, "WHERE IN THE WORLD IS THERANOS?" AND IF YOU GO TO THE PAGE AFTER THAT, THERE APPEARS TO BE A, WHAT IS LABELLED AS A "GEOGRAPHY TO DATE." CAN YOU EXPLAIN THE QUESTION AND THE ANSWER THAT ARE IN THESE SLIDES IN EXHIBIT 7742?
ELIZABETH A. HOLMES: YES. THIS IS A MAP OF ALL OF THE PLACES THAT THERANOS SYSTEMS HAD BEEN SHIPPED FOR USE IN CLINICAL STUDIES.
MR. DOWNEY: OKAY. AND THEN LET'S GO TO THE NEXT PAGE. BY THE WAY, WITH RESPECT TO MR. HRISTU'S TRANSMISSION OF THIS TO YOU IN 2009, DO YOU KNOW IF THIS WAS DONE IN CONNECTION WITH A PRESENTATION THAT YOU WERE GOING TO MAKE OR FOR ANY OTHER PURPOSE?
ELIZABETH A. HOLMES: IT LIKELY WOULD BE. I WOULD ASK FOR UPDATES ON OUR WORK BEFORE I WOULD GO INTO MEETINGS WHERE I WAS GIVING PRESENTATIONS.
MR. DOWNEY: OKAY. LET'S LOOK AT THE SLIDE NUMBER 3, WHICH IS LABELLED "COMPLETED SUCCESSES." CAN YOU EXPLAIN THIS SLIDE TO US?
ELIZABETH A. HOLMES: YES. THIS IS A LIST OF THE SUCCESSES THAT THE TEAM WAS HIGHLIGHTING FOR ME WITH STUDIES WITH DIFFERENT PHARMACEUTICAL COMPANIES AND THE STANDARD STUDY WE TALKED ABOUT, ANOTHER STUDY AT THE MAYO CLINIC.
MR. DOWNEY: OKAY. AND OTHER THAN THE REFERENCE TO STANFORD AND MAYO CLINIC, ARE THE OTHER, ARE THE OTHER ITEMS LISTED, ARE THESE ALL OF THE NAMES OF LARGE PHARMACEUTICAL COMPANIES?
ELIZABETH A. HOLMES: THEY ARE.
MR. DOWNEY: AND IS THIS GIVING A REPORT ON, ON THE STATUS OF THOSE AS BEING COMPLETED?
MR. DOWNEY: OKAY. AND THE TERM "SUCCESSES" IS USED. TO YOUR MIND, WHAT WAS A SUCCESS IN AN ENGAGEMENT WITH A PHARMACEUTICAL COMPANY IN 2008 OR 2009?
ELIZABETH A. HOLMES: A SUCCESS WAS THAT WE HAD SUCCESSFULLY ACHIEVED THE OBJECTIVES OF THE PROGRAM.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT THE NEXT PAGE. AND THIS PAGE IS LABELLED "ONGOING." AND IT LISTS A NUMBER OF ITEMS THEREUNDER. WHAT IS THIS SLIDE REPORTING ON?
ELIZABETH A. HOLMES: THESE STUDIES AT THIS TIME WERE LIVE, SO THE STUDIES WERE STILL ONGOING.
MR. DOWNEY: AND IF YOU GO BACK TO -- AND THE STUDIES THAT ARE REFERENCED HERE, ARE THEY BEING DONE IN CONNECTION WITH PHARMACEUTICAL COMPANIES?
MR. DOWNEY: AND IS THE MAYO CLINIC REFERENCE TO A RESEARCH AND TREATMENT CENTER?
ELIZABETH A. HOLMES: YES, THAT WAS WORK THAT WE WERE ALSO DOING IN CONJUNCTION WITH A PHARMACEUTICAL COMPANY.
MR. DOWNEY: OKAY. ALL RIGHT. LET ME ASK YOU TO GO BACK TO THE PRIOR SLIDE OF "COMPLETED SUCCESSES." AND DO YOU SEE THAT THE FIRST REFERENCE THERE IS TO NOVARTIS?
MR. DOWNEY: NOW, WE TALKED ON FRIDAY ABOUT THE DEMONSTRATION THAT YOU HAD DONE AT NOVARTIS IN 2016, AND WE TALKED ABOUT THE PRODUCT DEVELOPING AFTER THAT POINT. DID YOU ULTIMATELY DO SOME FORM OF STUDY OR PARTNERSHIP WITH NOVARTIS?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND WHAT DID YOU DO IN CONNECTION WITH THAT WORK WITH NOVARTIS?
ELIZABETH A. HOLMES: THIS STUDY HERE WAS A STUDY TESTING MARKERS OF INFLAMMATION AND LOOKING AT THOSE MARKERS IN CLINICAL PATIENTS WHO HAD SOME TYPE OF BONE DISORDER.
MR. DOWNEY: AND DID YOU DO OTHER WORK IN CONNECTION WITH NOVARTIS?
MR. DOWNEY: LET ME SHOW YOU EXHIBIT 15040.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: IS THIS AN EMAIL BETWEEN YOU AND AN INDIVIDUAL AT NOVARTIS?
MR. DOWNEY: YOUR HONOR, I MOVE TO ADMIT 15040.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15040 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: IF YOU'D LOOK AT THE TOP EMAIL, THIS APPEARS TO BE AN EMAIL FROM YOU TO AN IVAN BOTTOLI?
MR. DOWNEY: AND IS THAT B-O-T-T-O-L-I?
MR. DOWNEY: AND HE WORKED AT NOVARTIS?
ELIZABETH A. HOLMES: HE DID.
MR. DOWNEY: AND IF YOU GO DOWN TO THE EMAIL, YOU ARE REFERENCING THAT YOU ARE ATTACHING A COMPLETED VALIDATION STUDY REPORT SHOWING THERANOS'S ABILITY TO RUN A MULTIPLEXED CARTRIDGE, AND IT GOES ON TO DESCRIBE THE TESTS AND SO FORTH. IS THIS THE WORK IN CONNECTION WITH ONE OF THE PROJECTS THAT YOU'VE JUST DESCRIBED?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: AND WHY WERE YOU FORWARDING A VALIDATION STUDY REPORT TO MR. BOTTOLI AT THIS TIME?
ELIZABETH A. HOLMES: I'M JUST LOOKING AT THE EMAIL. IT LOOKS LIKE THERANOS HAD COMPLETED THE VALIDATION AND WAS SENDING IT -- I WAS SENDING IT TO DR. BOTTOLI FOR HIS REVIEW.
MR. DOWNEY: OKAY. AND DID THERANOS'S PARTNERSHIP WITH NOVARTIS IN SOME INSTANCES LEAD TO THERANOS DEVICES BEING DEPLOYED FOR EVALUATION IN EUROPE?
ELIZABETH A. HOLMES: IT DID.
MR. DOWNEY: OKAY. AND WERE REFERENCE ASSAYS USED IN CONNECTION WITH THOSE STUDIES?
MR. DOWNEY: AND CAN YOU EXPLAIN WHAT REFERENCE ASSAYS WERE TO THE JURY?
ELIZABETH A. HOLMES: REFERENCE ASSAYS IS JUST REFERRING TO TRADITIONAL ASSAYS THAT WERE RUN IN A CLINICAL LAB THE WAY THEY'RE NORMALLY RUN.
MR. DOWNEY: AND WERE THERANOS ASSAYS RUN AT THE SAME TIME?
MR. DOWNEY: AND WAS THE POINT OF DOING BOTH TO COMPARE THE RESULTS FROM EACH?
MR. DOWNEY: AND WHAT DO YOU RECALL ABOUT HOW THERANOS'S PERFORMANCE COMPARED TO THE REFERENCE ASSAY IN CONNECTION WITH THAT DEPLOYMENT TO EUROPE?
ELIZABETH A. HOLMES: I REMEMBER IT BEING REALLY GOOD.
MR. DOWNEY: OKAY. IF YOU GO BACK TO EXHIBIT 7742, AND WE LOOK AT THE THIRD PAGE OF THAT EXHIBIT. DO YOU SEE THE LAST TWO ENTRIES REFER TO ASTRAZENECA?
MR. DOWNEY: AND ASTRAZENECA IS A -- WE LOOKED AT A DOCUMENT FRIDAY WHERE A CONTRACT HAD BEEN SIGNED BETWEEN THERANOS AND ASTRAZENECA. DO YOU RECALL THAT?
ELIZABETH A. HOLMES: I THINK SO.
MR. DOWNEY: WELL, LET ME ASK YOU TO LOOK QUICKLY AT EXHIBIT 7753.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: AND I'LL JUST ASK YOU, IS THIS AN AGREEMENT BETWEEN THERANOS AND ASTRAZENECA RELATED TO WORK WITH THERANOS TECHNOLOGY?
MR. DOWNEY: AND IF YOU COULD JUST TAKE A MOMENT TO LOOK AT PAGE 185 OF THAT EXHIBIT. IT'S BATES LABEL 5903. AND IF YOU CAN BLOW UP THE BOTTOM HALF OF THAT PAGE. IS THIS -- DO YOU SEE AT THE TOP IT SAYS, "ASTRAZENECA IS VALIDATING THE THERANOS SYSTEM BY UTILIZING CARTRIDGES DESIGNED TO RUN MULTIPLEXED ASSAYS"?
MR. DOWNEY: IS THAT WHAT THE PURPOSE OF THIS CONTRACT WAS?
MR. DOWNEY: AND DID THE, DID THE STUDY THAT IS DESCRIBED IN THIS CONTRACT, DID THAT ACTUALLY PROCEED BETWEEN THERANOS AND ASTRAZENECA?
ELIZABETH A. HOLMES: IT DID.
MR. DOWNEY: OKAY. LET'S LOOK DOWN AT THE LAST SENTENCE OF THAT SAME FIRST PARAGRAPH. IT SAYS, "THE THERANOS SYSTEM WILL BE INCORPORATED INTO A CLINICAL TRIAL UTILIZING ONCOLOGY SUBJECTS IN THE UK." CAN YOU DESCRIBE WHAT THE ACTUAL USE OF THERANOS TECHNOLOGY WAS TO BE IN THIS PARTICULAR STUDY?
ELIZABETH A. HOLMES: YES. WE WORKED WITH THE ROYAL MARSDEN HOSPITAL IN THE UK AND TESTING WAS DONE ON PATIENTS COMPARED TO A TRADITIONAL CLINICAL LAB. I THINK HERE SOME OF THE TESTING WAS DONE AT HOME, AND SOME OF THE TESTING WAS DONE IN THE CLINIC.
MR. DOWNEY: AND DID YOU UNDERSTAND THAT PART OF THE POINT OF THE STUDY WAS TO VALIDATE THERANOS'S SYSTEM?
ELIZABETH A. HOLMES: I DID.
MR. DOWNEY: AND DID YOU UNDERSTAND THAT IF THERANOS WAS SUCCESSFUL IN VALIDATING ITS SYSTEM AS PART OF THIS ASTRAZENECA PROJECT, THAT IT WOULD BE ABLE TO PARTICIPATE IN CLINICAL TRIALS THAT ASTRAZENECA WAS RUNNING ON DRUGS?
MR. DOWNEY: AND CAN YOU, CAN YOU DESCRIBE FOR US HOW YOU UNDERSTOOD THIS PROCESS OF VALIDATION WORKED AT PHARMACEUTICAL COMPANIES AT THIS TIME AND HOW IT RELATED TO CLINICAL TRIALS AT THE PHARMACEUTICAL COMPANIES?
ELIZABETH A. HOLMES: YES. IT WAS DIFFERENT FOR EVERY COMPANY THAT WE WORKED WITH, BUT ESSENTIALLY WITH A GIVEN GROUP, WE WOULD TEST THE THERANOS TECHNOLOGY AGAINST SOME STANDARD, AND IF WE WERE ABLE TO SUCCESSFUL HIT THAT STANDARD, THEN WE COULD RUN CLINICAL STUDIES WITH THOSE PHARMACEUTICAL COMPANIES.
MR. DOWNEY: OKAY. AND IN ADDITION TO DOING THAT WORK FOR PHARMACEUTICAL COMPANIES, WAS THERANOS ALSO DEVELOPING ASSAYS IN CONNECTION WITH THOSE STUDIES?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND DID YOU DO THAT FOR ASTRAZENECA?
ELIZABETH A. HOLMES: I THINK SO.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT EXHIBIT 195.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: AND IS THIS AN EMAIL EXCHANGE BETWEEN SOMEONE FROM ASTRAZENECA AND YOU AND OTHERS AT THERANOS IN 2009?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 195.
MR. LEACH: 801, 802, YOUR HONOR. IF IT'S OFFERED FOR ANOTHER PURPOSE, THAT'S FINE.
MR. DOWNEY: YOUR HONOR, IT'S OFFERED CERTAINLY TO SHOW THE DEFENDANT'S STATE OF MIND AND INTENT, IF NOTHING ELSE.
JUDGE DAVILA: AS TO? STATE OF MIND AS TO?
MR. DOWNEY: AS TO WHAT HAS BEEN QUESTIONED IN THE GOVERNMENT'S CASE, THE VALIDITY OF THE TECHNOLOGY.
JUDGE DAVILA: AS TO? HER STATE OF MIND AS TO HER OPINION OF HER TECHNOLOGY, THERANOS'S TECHNOLOGY.
MR. DOWNEY: HER UNDERSTANDING OF THE TECHNOLOGY AS OF THIS POINT IN TIME IN 2009.
JUDGE DAVILA: ALL RIGHT. THANK YOU. IT'S -- LADIES AND GENTLEMEN, THIS IS ADMITTED NOT FOR THE TRUTH OF THE MATTER ASSERTED IN THE DOCUMENT THAT YOU'LL SEE, BUT RATHER FOR THE LIMITED ISSUE OF THE STATE OF MIND OF MS. HOLMES AS TO HER KNOWLEDGE OF THE TECHNOLOGY AT THIS POINT IN TIME. IT'S ADMITTED FOR THAT LIMITED PURPOSE, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 195 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: LET'S LOOK AT THE HEADER OF THE EMAIL, AND CAN YOU EXPLAIN WHO THE PEOPLE ARE WHO ARE COPIED IN THE EMAIL FROM ALASTAIR GREYSTOKE ON APRIL 8TH OF 2009?
ELIZABETH A. HOLMES: YES. THEY ARE SCIENTIFIC AND CLINICAL EXECUTIVES AND SCIENTISTS AT ASTRAZENECA.
MR. DOWNEY: THAT'S MS. DIVE AND MR. CLACK?
ELIZABETH A. HOLMES: OH, SORRY. I WAS LOOKING AT THE TOP EMAIL. MS. DIVE, I BELIEVE, RAN THE MANCHESTER PATTERSON INSTITUTE FOR CANCER RESEARCH WHERE WE ALSO DID SOME WORK WITH ASTRAZENECA.
MR. DOWNEY: OKAY. AND THE EMAIL IS FROM DR. GREYSTOKE?
MR. DOWNEY: AND WAS DR. GREYSTOKE ONE OF THE PRINCIPAL CONTACTS THAT THERANOS HAD AT ASTRAZENECA?
ELIZABETH A. HOLMES: MY MEMORY IS HE WAS ONE OF THE SCIENTISTS THAT WE WORKED WITH.
MR. DOWNEY: IF YOU LOOK AT THE BODY OF THE EMAIL, CAN YOU EXPLAIN TO US WHAT DR. GREYSTOKE IS REPORTING IN CONNECTION WITH THE ASTRAZENECA WORK THAT THERANOS DID?
ELIZABETH A. HOLMES: HE'S ASKING IF HE COULD PRESENT THE WORK THAT ASTRAZENECA DID WITH THERANOS AT SOME TYPE OF CONFERENCE BECAUSE HE THINKS THAT THE REPRODUCIBILITY DATA THAT WE SHOWED BETWEEN THE THERANOS TEST AND THE TRADITIONAL TEST WAS REALLY WORTH SHOWING.
MR. DOWNEY: WELL, WHEN YOU SAY REPRODUCIBILITY DATA, WHAT DOES THAT MEAN?
ELIZABETH A. HOLMES: IT MEANS THAT WE WERE ABLE TO SHOW THAT THE THERANOS TEST WAS VERY REPEATABLE IN WHOLE BLOOD AND THAT IT CORRELATED WELL WITH THE TRADITIONAL TEST THAT WAS BEING USED BY THEIR LAB.
MR. DOWNEY: OKAY. YOU CAN TAKE THAT DOWN. WAS MERCK ANOTHER PHARMACEUTICAL COMPANY THAT THERANOS DID WORK WITH?
MR. DOWNEY: AND I'LL SHOW YOU EXHIBIT 7753, WHICH I BELIEVE IS ALREADY IN EVIDENCE.
COURT CLERK: YES, IT IS.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: YOU CAN DISPLAY IT.
MR. DOWNEY: LOOKING AT THE TOP OF THIS DOCUMENT, CAN YOU EXPLAIN WHAT IT IS?
ELIZABETH A. HOLMES: YES. THIS IS A CONTRACT BETWEEN MERCK AND THERANOS.
MR. DOWNEY: AND IF YOU LOOK AT ATTACHMENT A, DO YOU SEE THAT THAT'S A WORK PLAN?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND DO YOU SEE "OBJECTIVE"?
MR. DOWNEY: WHERE IT SAYS, "TO ASSESS THE SENSITIVITY OF THERANOS'S ANALYTICAL PLATFORM. SPECIFICALLY, WE WOULD," I BELIEVE IT MAY BE A TYPO, "TO ASSESS THE SENSITIVITY OF THEIR ACTIVE GLUCAGON-LIKE PEPTIDE ASSAY IN HUMAN EDTA PLASMA SAMPLES." WAS THAT THE POINT OF THE STUDY?
MR. DOWNEY: AND IN LAYMAN'S TERMS, WHAT DOES THAT OBJECTIVE MEAN?
ELIZABETH A. HOLMES: MERCK WAS INTERESTED IN A TEST CALLED GLP-1, WHICH IS USED FOR DIABETES. IT'S A REALLY HARD TEST, AND SPECIFICALLY MEASURING THAT TEST AT REALLY LOW LEVELS IS HARD, AND SO THEY WANTED TO SEE HOW WELL THERANOS'S TEST PERFORMED AT THOSE LOW LEVELS.
MR. DOWNEY: AND DID YOU ULTIMATELY, DID YOU ULTIMATELY COMPLETE THE STUDY?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND DID THERANOS -- WAS THERANOS'S TECHNOLOGY EVALUATED?
MR. DOWNEY: WHAT WAS THE OUTCOME OF THE PROJECT?
ELIZABETH A. HOLMES: MERCK SENT DATA BACK TO THERANOS SHOWING HOW WELL WE PERFORMED AGAINST THEIR TRADITIONAL LAB ASSAYS AND SAID THAT THEY WOULD START WORKING WITH US TO FIND A CLINICAL STUDY THAT WE COULD USE OUR TECHNOLOGY IN.
MR. DOWNEY: AND WERE YOU EVER ABLE TO WORK WITH MERCK IN A CLINICAL STUDY?
MR. DOWNEY: LET ME ASK YOU NEXT ABOUT BRISTOL MYERS SQUIBB. IS BRISTOL MYERS SQUIBB ANOTHER LARGE PHARMACEUTICAL COMPANY?
MR. DOWNEY: AND DID THERANOS DO WORK WITH BRISTOL MYERS SQUIBB?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: WHEN DID YOU START DISCUSSING POTENTIAL PROJECTS WITH BRISTOL MYERS?
ELIZABETH A. HOLMES: EARLY -- AS EARLY AS 2005.
MR. DOWNEY: AND DID THERANOS AND BRISTOL MYERS ULTIMATELY AGREE TO DO A STUDY AT SOME POINT?
MR. DOWNEY: AND WHEN WAS THAT?
ELIZABETH A. HOLMES: I THINK IN 2008 OR SO.
MR. DOWNEY: AND AS PART OF THAT STUDY, DID BRISTOL MYERS HAVE AN OPPORTUNITY TO EVALUATE THERANOS'S TECHNOLOGY?
MR. DOWNEY: AND DO YOU RECALL WHAT HAPPENED IN THAT STUDY?
MR. LEACH: OBJECTION. CALLS FOR HEARSAY.
JUDGE DAVILA: CAN YOU ASK MAYBE A LITTLE MORE FOUNDATION ABOUT IT?
MR. DOWNEY: SURE. YEAH.
MR. DOWNEY: WELL, LET ME ASK THIS QUESTION. WERE YOU FAMILIAR WITH HOW THE STUDY WAS CONDUCTED?
MR. DOWNEY: AND DID YOU YOURSELF PARTICIPATE IN ELEMENTS OF DISCUSSION OF THE STUDY WITH BRISTOL MYERS?
ELIZABETH A. HOLMES: I DID.
MR. DOWNEY: DO YOU KNOW WHAT STEPS WERE TAKEN TO CONDUCT THE STUDY?
MR. DOWNEY: WHAT STEPS WERE TAKEN TO EVALUATE THERANOS'S TECHNOLOGY IN CONNECTION WITH THIS 2008 BRISTOL MYERS STUDY OF THERANOS'S TECHNOLOGY?
ELIZABETH A. HOLMES: DEVICES AND CARTRIDGES WERE SHIPPED TO BRISTOL MYERS'S FACILITY IN I THINK IT WAS NEW JERSEY, AND THEY TESTED THOSE DEVICES AND CARTRIDGES AGAINST THEIR TRADITIONAL ASSAY IN THEIR LAB.
MR. DOWNEY: OKAY. AND AFTER THAT PROJECT, DID YOU HAVE FURTHER DISCUSSIONS WITH BRISTOL MYERS ABOUT POTENTIALLY PARTICIPATING IN OTHER PROJECTS?
MR. DOWNEY: AND AT WHAT POINT -- AT 2010, DID YOU HAVE CONVERSATIONS WITH BRISTOL MYERS ABOUT POTENTIALLY PARTICIPATING IN A PARTICULAR PROGRAM?
MR. DOWNEY: AS OF 2010, HAD THERANOS BEGUN TO FOCUS ON EFFORTS TO USE ITS TECHNOLOGY IN CONNECTION WITH RETAIL?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND DID ANY -- DID THERANOS PARTICIPATE IN ANY CLINICAL STUDY AS A RESULT OF THOSE DISCUSSIONS IN 2010?
ELIZABETH A. HOLMES: WE DIDN'T.
MR. DOWNEY: ALL RIGHT. LET ME ASK YOU NEXT ABOUT CENTOCOR. IS CENTOCOR ANOTHER LARGE PHARMACEUTICAL COMPANY?
MR. DOWNEY: DID THERANOS DO SOME WORK WITH CENTOCOR AS WELL?
MR. DOWNEY: AND LET ME ASK YOU TO LOOK AT EXHIBIT 7753, WHICH IS ALSO ALREADY IN EVIDENCE. IF YOU LOOK AT THE FIRST PAGE, DO YOU SEE THAT THIS IS A PROJECT AGREEMENT BETWEEN THERANOS AND CENTOCOR?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK NEXT AT PAGE 79 OF THIS AGREEMENT. IF YOU WOULD LOOK AT PAGE 79, DO YOU SEE UNDER DELIVERABLES THERE'S A DESCRIPTION OF THE WORK THAT WAS TO BE DONE IN CONNECTION WITH THE THERANOS-CENTOCOR AGREEMENT?
MR. DOWNEY: AND WHAT WORK WAS TO BE DONE UNDER THAT AGREEMENT?
ELIZABETH A. HOLMES: THERE WERE MULTIPLE STAGES OF THE AGREEMENT. THE FIRST STAGE WAS THAT CENTOCOR WANTED US TO DEVELOP A TEST TO MEASURE THEIR DRUG ON SMALL SAMPLES, AND THEY ALSO WANTED US TO MEASURE -- DEVELOP TESTS TO MEASURE MARKERS THAT WOULD HELP THEM SEE HOW WELL THEIR DRUG WAS WORKING ON SMALL SAMPLES.
MR. DOWNEY: AND WITH THOSE DIFFERENT GOALS, HOW DID YOU END UP STRUCTURING THE PROGRAM TO LOOK AT THE VALIDITY OF THERANOS TECHNOLOGY?
ELIZABETH A. HOLMES: CENTOCOR GAVE THERANOS A SERIES OF CRITERIA THAT WE HAD TO HIT ONCE WE DEVELOPED THE TESTS TO VALIDATE THEM, AND OUR SCIENTISTS DEVELOPED THE CHEMISTRIES, THE ASSAYS, AND THEN RAN THOSE TESTS AND PRESENTED THAT DATA TO CENTOCOR.
MR. DOWNEY: DID CENTOCOR FIND THAT THERANOS HAD SATISFIED THE REQUIREMENTS THAT HAD BEEN SET FORTH?
ELIZABETH A. HOLMES: THEY DID.
MR. DOWNEY: WERE THERANOS DEVICES DEPLOYED IN ANY KIND OF TRIAL?
MR. DOWNEY: CAN YOU EXPLAIN THE TRIAL IN WHICH THERANOS DEVICES WERE DEPLOYED?
ELIZABETH A. HOLMES: THE TRIAL WAS A STUDY IN BELGIUM IN WHICH PEOPLE WERE DOING OUR BLOOD TESTS AT THEIR HOMES AND THEN ALSO GOING INTO A CLINIC AND TESTS FROM THE THERANOS SYSTEM WERE COMPARED AGAINST TESTS FROM THE TRADITIONAL LAB.
MR. DOWNEY: AND HOW DID THERANOS'S SYSTEM PERFORM?
ELIZABETH A. HOLMES: IT PERFORMED WELL.
MR. DOWNEY: WAS THERANOS PAID UNDER THIS CONTRACT WITH CENTOCOR?
ELIZABETH A. HOLMES: WE WERE.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK NEXT AT EXHIBIT 3241.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: WHAT IS EXHIBIT 3241?
ELIZABETH A. HOLMES: IT IS AN EMAIL EXCHANGE BETWEEN DR. BELKOWSKI AT CENTOCOR, MYSELF, AND OTHERS AT THERANOS ABOUT HIS REQUEST TO PRESENT OUR DATA AT A CONFERENCE.
MR. DOWNEY: LET ME ASK YOU TO LOOK FIRST AT -- WITHIN THIS EMAIL AT THE EMAIL AT 3:26 P.M. WELL, YOUR HONOR, I HAVE NOT MOVED THIS INTO EVIDENCE. 3241 I MOVE TO ADMIT INTO EVIDENCE.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 3241 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: LET ME ASK YOU TO LOOK AT THIS EMAIL FROM STANLEY BELKOWSKI TO YOURSELF. IS DR. BELKOWSKI A SCIENTIST FROM CENTOCOR?
ELIZABETH A. HOLMES: HE WAS.
MR. DOWNEY: AND CAN YOU EXPLAIN WHAT THIS EMAIL IS DISCUSSING?
ELIZABETH A. HOLMES: YES. HE'S GOING TO A BIG BIOMARKER MEETING AND HE'S ASKING IF HE COULD PRESENT DATA FROM THE STUDIES THAT CENTOCOR RAN WITH US ON THE PERFORMANCE OF OUR SYSTEM.
MR. DOWNEY: OKAY. AND NOW IF YOU SKIP UP FROM THERE TO THE EMAIL AT 6:20 P.M. ON THAT SAME DAY. IS THIS DR. BELKOWSKI REPORTING ON THE RESULTS OF HIS PRESENTATION?
MR. DOWNEY: AND WHAT DID HE REPORT TO YOU ABOUT HOW THE PRESENTATION WENT?
ELIZABETH A. HOLMES: HE SAYS IT WENT VERY WELL.
MR. DOWNEY: AND DID HE INDICATE THAT CENTOCOR WAS -- QUESTIONS CENTOCOR HAD ASKED -- WHETHER OTHERS AT CENTOCOR HAD ASKED WHETHER THERANOS COULD BE USED AS A PLATFORM IN CONNECTION WITH CERTAIN CLINICAL TRIALS?
ELIZABETH A. HOLMES: I THINK HE'S SAYING THAT --
MR. LEACH: OBJECTION, YOUR HONOR. LEADING.
BY MR. DOWNEY:
MR. DOWNEY: LET ME ASK, WHAT DOES HE SAY IN THE SECOND SENTENCE THAT HE RECEIVED SOME QUESTIONS ABOUT THE POSSIBILITY OF USING THERANOS AS A PLATFORM?
ELIZABETH A. HOLMES: I THINK HE'S SAYING THAT AT HIS CONFERENCE, PEOPLE WERE ASKING QUESTIONS WHEN HE DID THE PRESENTATION ABOUT WHETHER THERANOS COULD BE USED TO MEASURE THESE OTHER MARKERS CALLED TOX BIOMARKERS.
MR. DOWNEY: WERE THESE OTHERS OUTSIDE OF CENTOCOR?
ELIZABETH A. HOLMES: YES, OTHER PHARMA PEOPLE.
MR. DOWNEY: ALL RIGHT. LET ME ASK YOU NEXT ABOUT GLAXOSMITHKLINE. IS GLAXOSMITHKLINE ANOTHER PHARMACEUTICAL COMPANY?
JUDGE DAVILA: MR. DOWNEY, BEFORE WE GET INTO THIS, SHOULD WE TAKE A BREAK NOW? AND SHOULD WE TAKE ABOUT 20, 25 MINUTES?
MR. DOWNEY: SURE. THANK YOU, YOUR HONOR.
JUDGE DAVILA: LET'S TAKE A BREAK NOW, LADIES AND GENTLEMEN. ABOUT 25 MINUTES, 25 MINUTES, AND THEN WE'LL RESUME ON THIS. THANK YOU.
(RECESS FROM 11:46 A.M. UNTIL 12:15 P.M.)
JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. PLEASE BE SEATED. OUR JURY IS PRESENT AND MS. HOLMES IS PRESENT. MR. DOWNEY, WOULD YOU LIKE TO CONTINUE?
MR. DOWNEY: I WOULD, YOUR HONOR. THANK YOU.
MR. DOWNEY: DID THERANOS ALSO CONTRACT WITH GLAXOSMITHKLINE?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND WHAT WORK DID THERANOS DO FOR GLAXOSMITHKLINE?
ELIZABETH A. HOLMES: WE RAN A COUPLE OF STUDIES. ONE FOCUSSED ON METABOLIC MARKERS OR DIABETES MARKERS IN THEIR LAB IN RESEARCH TRIANGLE PARK.
MR. DOWNEY: AND DID GLAXOSMITHKLINE EVALUATE THERANOS'S TECHNOLOGY AS PART OF THAT WORK?
MR. DOWNEY: LET ME SHOW YOU EXHIBIT 112, WHICH IS ALREADY IN EVIDENCE. AND DO YOU SEE THAT THIS IS AN EMAIL FORWARDING TO YOU GSK'S EVALUATION OF THERANOS SYSTEMS?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: LET ME ASK YOU TO LOOK AT PAGE 3.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: AND DO YOU SEE -- IS THIS FEEDBACK FROM GSK ON THERANOS'S SYSTEMS?
MR. DOWNEY: AND DID GSK CONCLUDE THAT THERANOS'S DATA SHOWED GOOD CORRELATION WITH REFERENCE ASSAYS?
ELIZABETH A. HOLMES: IT DOES.
MR. DOWNEY: OKAY. DID IT ALSO CONCLUDE THE MACHINES WORKED WELL?
MR. DOWNEY: AND WHAT ELSE DO YOU RECALL ABOUT GSK'S CONCLUSIONS REGARDING THERANOS'S TECHNOLOGY?
ELIZABETH A. HOLMES: I REMEMBER THEM SAYING THAT THEY THOUGHT OUR SYSTEM ELIMINATED THE NEED FOR A LAB.
MR. DOWNEY: AND DO YOU RECALL WHETHER THEY RECOMMENDED THAT GSK USE THERANOS IN CONNECTION WITH CLINICAL STUDIES GOING FORWARD?
MR. DOWNEY: LET'S TURN TO ANOTHER PHARMACEUTICAL COMPANY, SCHERING-PLOUGH. YOU'VE BEEN PRESENT HERE DURING TRIAL. YOU KNOW THERE'S BEEN TESTIMONY REGARDING SCHERING-PLOUGH IN THE CASE?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: DID THERANOS CONTRACT WITH SCHERING-PLOUGH?
MR. DOWNEY: AND WHAT WORK DID THERANOS DO WITH SCHERING-PLOUGH?
ELIZABETH A. HOLMES: WE DID A VALIDATION FOR SCHERING-PLOUGH.
MR. DOWNEY: AND WHAT WAS THE NATURE OF THAT VALIDATION?
ELIZABETH A. HOLMES: THERE WAS A VERY COMPREHENSIVE SET OF CRITERIA THAT SCHERING-PLOUGH WORKED WITH OUR TEAM TO ESTABLISH. WE TESTED A NUMBER OF OUR ASSAYS AGAINST THOSE CRITERIA AND SENT THEM THE DATA.
MR. DOWNEY: AND DID THERANOS PROVIDE A REPORT TO SCHERING-PLOUGH ABOUT ITS CONCLUSIONS ABOUT THE RESULTS OF THAT EVALUATION?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: DO YOU PERSONALLY RECALL WHETHER SCHERING-PLOUGH EVER PROVIDED FEEDBACK ON THAT?
MR. DOWNEY: DO YOU RECALL ANY DIRECT FEEDBACK FROM DR. CULLEN?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND WHAT DO YOU RECALL ABOUT THAT?
MR. LEACH: YOUR HONOR, YOUR HONOR, HEARSAY UNLESS THIS IS OFFERED FOR A LIMITED PURPOSE.
JUDGE DAVILA: CAN YOU LAY A FOUNDATION, MAYBE A BETTER FOUNDATION OR --
MR. DOWNEY: SURE. SURE.
MR. DOWNEY: WAS DR. CULLEN ONE OF THE SCIENTISTS INVOLVED IN SCHERING-PLOUGH'S WORK WITH THERANOS?
ELIZABETH A. HOLMES: SHE WAS.
MR. DOWNEY: AND DID YOU MEET WITH DR. CULLEN AS PART OF THE SCHERING-PLOUGH WORK THAT YOU'VE JUST DESCRIBED?
MR. DOWNEY: AND DID YOU DISCUSS WITH HER WHILE SHE WAS AT SCHERING-PLOUGH THE RESULTS OF THE SCHERING-PLOUGH EVALUATION OF THERANOS'S TECHNOLOGY?
ELIZABETH A. HOLMES: MY TEAM MEMBER DID.
MR. DOWNEY: OKAY. DO YOU RECALL CONSTANCE CULLEN EVER TELLING YOU ANYTHING ABOUT THERANOS'S TECHNOLOGY VALIDATION WHILE SHE WAS AT SCHERING-PLOUGH?
ELIZABETH A. HOLMES: NOT ME.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT EXHIBIT 15045.
JUDGE DAVILA: 15045?
MR. DOWNEY: 15045.
JUDGE DAVILA: I DON'T BELIEVE IT'S IN MY BINDER.
MR. DOWNEY: THAT'S BECAUSE I HAVEN'T GIVEN IT TO YOU. MY APOLOGIES, YOUR HONOR.
(HANDING.)
MR. DOWNEY: (HANDING.) DID SCHERING-PLOUGH ULTIMATELY BECOME PART OF MERCK, ANOTHER PHARMACEUTICAL COMPANY?
ELIZABETH A. HOLMES: IT DID.
MR. DOWNEY: AND DID YOU HAVE DISCUSSIONS WITH MERCK ABOUT POTENTIAL WORK WITH MERCK IN 2009 AND 2010?
MR. DOWNEY: LET ME ASK YOU TO LOOK AT 15045. IS THAT AN EMAIL BETWEEN YOU AND ANOTHER INDIVIDUAL AT THERANOS DISCUSSING POTENTIAL WORK WITH MERCK IN 2010?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15045.
MR. LEACH: 801, 802, YOUR HONOR.
MR. DOWNEY: I DON'T HAVE ANY OBJECTION, YOUR HONOR, TO THIS BEING ADMITTED FOR A LIMITED PURPOSE.
JUDGE DAVILA: THAT PURPOSE WOULD BE THE STATE OF MIND OF MS. HOLMES IN RELATION TO?
MR. DOWNEY: IN RELATION TO FEEDBACK FROM SCHERING-PLOUGH, THEN PART OF MERCK, REGARDING THERANOS'S TECHNOLOGY.
JUDGE DAVILA: OKAY. ALL RIGHT. LADIES AND GENTLEMEN, THIS WILL BE ADMITTED FOR THE LIMITED PURPOSE OF THE STATE OF MIND OF MS. HOLMES AS TO HER KNOWLEDGE OF FEEDBACK, REPORTS BACK FROM SCHERING-PLOUGH THAT INFORM HER AS TO THE NATURE OF THERANOS'S TECHNOLOGY. IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15045, LIMITED PURPOSE, WAS RECEIVED IN EVIDENCE.)
MR. DOWNEY: THANK YOU, YOUR HONOR.
MR. DOWNEY: LET ME ASK YOU TO LOOK AT THE ADDRESS ON TOP, IF YOU COULD, THE ADDRESS BLOCK ON TOP?
MR. DOWNEY: AND WAS MS. BALKENHOL RESPONSIBLE FOR SOME OF THE PHARMACEUTICAL PROGRAMS AT -- ON BEHALF OF THERANOS IN 2010?
ELIZABETH A. HOLMES: YES. SHE WOULD SERVE AS A POINT PERSON FOR A NUMBER OF PARTNERS AND OTHER CONTACTS.
MR. DOWNEY: OKAY. AND DO YOU SEE THAT SHE -- THAT THE SUBJECT OF THE EMAIL IS, "PLEASE CALL ME BEFORE YOUR MERCK CALL - JUST HAD A GREAT CALL WITH CONNIE CULLEN"?
MR. DOWNEY: AND IF YOU GO DOWN TO THE THIRD PARAGRAPH AND LOOK AT THE FIRST COUPLE OF SENTENCES. DO YOU SEE THAT THIS IS MS. BALKENHOL REPORTING ON A CONVERSATION THAT SHE HAD HAD WITH DR. CULLEN ABOUT THERANOS?
MR. DOWNEY: AND DO YOU RECALL THIS WOULD HAVE BEEN ABOUT A YEAR OR SO AFTER THERANOS'S PROGRAM WITH SCHERING-PLOUGH HAD ENDED?
MR. DOWNEY: DO YOU SEE SHE SAYS, "SHE SAID SOMEONE IN HER GROUP REVIEWED THE DRAFT VALIDATION FROM A LONG TIME AGO AND THINKS IT WOULD BE HELPFUL TO HAVE THE SCIENTISTS TALK ONE ON ONE. "THEN SHE STARTED TALKING ABOUT RUNNING THE COMBINED GROUPS AND SAID THAT THEY'VE DONE A HIGH LEVEL ANALYSIS WITHIN THE NEW ORGANIZATION AND THAT THE MERCK FOLKS ARE INTRIGUED BY IT." WHAT DID YOU UNDERSTAND WAS BEING CONVEYED IN THIS REPORT TO YOU IN 2010?
ELIZABETH A. HOLMES: THAT DR. CULLEN WAS TELLING CAROLYN THAT SCHERING-PLOUGH HAD REVIEWED OUR VALIDATION; THAT SHE WANTED TO HAVE OUR SCIENTISTS IN TOUCH; AND THAT SHE HAD TALKED ABOUT THAT WORK WITH THIS NEW ORGANIZATION THAT WAS PUT TOGETHER WITHIN MERCK, AND THAT THEY ARE INTRIGUED BY IT.
MR. DOWNEY: OKAY. LET ME DIRECT YOU TO THE LAST SENTENCE OF THAT PARAGRAPH. AND DO YOU SEE THAT SHE SAYS, "YOU SHOULD FEEL FREE TO MENTION HER NAME TO THE MERCK FOLKS AND THAT IT'S KNOWN THAT SHE'LL BE RUNNING THAT GROUP." WHAT DID YOU UNDERSTAND THAT SENTENCE TO MEAN?
ELIZABETH A. HOLMES: I UNDERSTOOD THAT SHE WAS SAYING TO CAROLYN THAT SHE COULD BE A REFERENCE FOR US AS WE WORKED ON OTHER CONTRACTS WITHIN MERCK.
MR. DOWNEY: AND DO YOU SEE THE FOURTH PARAGRAPH THERE THAT BEGINS, "ALL IN ALL"?
MR. DOWNEY: IT SAYS, "ALL IN ALL, IT WAS AWESOME, I THINK." DO YOU SEE THAT?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: DID YOU UNDERSTAND THAT THE FEEDBACK THAT MS. BALKENHOL HAD GOTTEN WAS THAT DR. CULLEN HAD A FAVORABLE VIEW OF THERANOS'S TECHNOLOGY?
ELIZABETH A. HOLMES: I DID.
MR. DOWNEY: AND DID YOU UNDERSTAND THAT MS. BALKENHOL WAS CONVEYING TO YOU THAT SHE THOUGHT DR. CULLEN COULD SERVE AS A REFERENCE FOR PURPOSES OF GETTING ADDITIONAL BUSINESS WITHIN MERCK AFTER THE MERGER BETWEEN MERCK AND SCHERING-PLOUGH?
MR. LEACH: OBJECTION. LEADING.
MR. DOWNEY: I'M JUST ASKING IF SHE UNDERSTOOD.
JUDGE DAVILA: OVERRULED. YOU CAN ANSWER THE QUESTION. DID YOU UNDERSTAND THE QUESTION?
ELIZABETH A. HOLMES: I DID.
JUDGE DAVILA: YOU CAN ANSWER.
BY MR. DOWNEY:
MR. DOWNEY: LET'S TURN TO CELGENE. DID THERANOS DID WORK WITH CELGENE?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: WHAT PROJECTS DO YOU RECALL THERANOS DOING WITH CELGENE?
ELIZABETH A. HOLMES: WE DID A NUMBER OF PROJECTS FOR CELGENE, MOSTLY FOCUSSED ON OUR SOFTWARE AND THE PREDICTIVE MODELS WE WERE BUILDING.
MR. DOWNEY: AND WAS THERE A CONTRACT BETWEEN CELGENE AND THERANOS?
MR. DOWNEY: AND UNDER THE TERMS OF THAT CONTRACT, WERE CERTAIN MILESTONES SPECIFIED THAT THERANOS HAD TO MEET TO GET PAID?
MR. DOWNEY: AND WAS ONE OF THOSE MILESTONES VALIDATION OF THERANOS'S TECHNOLOGY?
MR. DOWNEY: DID THERANOS SUBMIT A VALIDATION REPORT TO CELGENE TO DOCUMENT THE VALIDATION OF ITS TECHNOLOGY?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND DID YOU BELIEVE THAT THAT WORK CONSTITUTED A VALIDATION OF THE TECHNOLOGY?
ELIZABETH A. HOLMES: I DID.
MR. DOWNEY: AND DID THERANOS GET PAID IN CONNECTION WITH THAT CONTRACT?
MR. DOWNEY: DID IT GET PAID THE FULL AMOUNT OF THE CONTRACT?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: LET ME ASK YOU ABOUT A JAPANESE PHARMACEUTICAL COMPANY, DAIICHI-SANKYO. DID THERANOS WORK ON A PARTNERSHIP WITH DAIICHI?
ELIZABETH A. HOLMES: WE DID WORK THROUGH THEM THROUGH THE MAYO CLINIC.
MR. DOWNEY: AND DID YOU DO -- WHAT KIND OF WORK DID YOU DO WITH THE MAYO CLINIC?
ELIZABETH A. HOLMES: WE TESTED OUR TECHNOLOGY AT THE MAYO CLINIC AND THEN RAN A CLINICAL STUDY FOR THEM.
MR. DOWNEY: AND WHEN YOU SAY YOU TESTED YOUR TECHNOLOGY, WHAT DID THAT CONSIST OF?
ELIZABETH A. HOLMES: AGAIN, TESTING THE TESTS, THE CARTRIDGES, THE DEVICE, THE SOFTWARE AGAINST TRADITIONAL TESTS AND COMPARING THE RESULTS.
MR. DOWNEY: AND AFTER THAT, WHAT WORK DID YOU DO AT THE MAYO CLINIC?
ELIZABETH A. HOLMES: THE MAYO CLINIC THEN USED US IN A CLINICAL STUDY ON DIABETES PATIENTS.
MR. DOWNEY: LET ME ASK YOU TO LOOK AT 15044.
ELIZABETH A. HOLMES: I'M NOT SURE IF I HAVE 44.
JUDGE DAVILA: IT'S ON ITS WAY UP, I THINK.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: MAY I APPROACH THE WITNESS?
JUDGE DAVILA: YES.
BY MR. DOWNEY:
MR. DOWNEY: (HANDING.)
ELIZABETH A. HOLMES: THANK YOU.
MR. DOWNEY: CAN YOU TELL US WHAT 15044 IS?
ELIZABETH A. HOLMES: IT LOOKS LIKE ONE OF THE UPDATES FROM ONE OF OUR TEAM MEMBERS ON ACTIVE WORK SHE WAS DOING WITH PHARMACEUTICAL COMPANIES.
MR. DOWNEY: DOES IT DISCUSS THE WORK THAT THERANOS WAS DOING WITH THE MAYO CLINIC, AND I SPECIFICALLY DIRECT YOUR ATTENTION TO THE BOTTOM OF PAGE 5, TOP OF PAGE 6.
ELIZABETH A. HOLMES: IT DOES.
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15044.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15044 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: IF YOU LOOK AT THE FIRST PAGE, THIS IS AN EMAIL FROM YOU TO SUSAN DIGIAMO?
MR. DOWNEY: AND IS SHE AN INTERNAL THERANOS PERSON?
ELIZABETH A. HOLMES: SHE IS. I THINK IT'S ACTUALLY AN EMAIL FROM HER TO ME.
MR. DOWNEY: I'M SORRY, I BEG YOUR PARDON, IT IS. AND IS SHE THE ONE WHO PREPARED THE REPORT THAT IS ATTACHED HERETO?
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK THEN AT PAGE 5?
MR. LEACH: YOUR HONOR, I DON'T MEAN TO INTERRUPT, BUT THERE'S A REDACTION ON THE SCREEN THAT I THINK IS RELEVANT TO THIS EXHIBIT THAT I THINK SHOULD BE DISPLAYED IN SOME FORM UP AT THE TOP.
JUDGE DAVILA: I'M NOT SURE I SEE IT. COULD YOU -- MR. DOWNEY, COULD YOU TALK WITH MR. LEACH ABOUT THIS.
MR. DOWNEY: YES. LET ME SEE WHAT HIS CONCERN IS.
(DISCUSSION AMONGST COUNSEL FOR THE GOVERNMENT AND DEFENSE OFF THE RECORD.)
MR. DOWNEY: OKAY. LET ME EXPLAIN. I HAVE NO OBJECTION TO THAT. BUT THERE'S A PERSONAL EMAIL ADDRESS OF AN INDIVIDUAL THAT IS THE TO ADDRESSEE HERE. I REDACTED IT CONSISTENT WITH THE PROTOCOLS THAT WE HAVE BEEN FOLLOWING. MR. LEACH WANTS TO ASK SPECIFICALLY ABOUT THAT HOTMAIL ACCOUNT, SO HE ASKED THAT WE NOW DISPLAY IT AS PART OF THE -- WHAT IS DISPLAYED. I HAVE NO OBJECTION TO THAT?
JUDGE DAVILA: OKAY. CAN YOU UNREDACT IT THEN IN YOUR --
MR. DOWNEY: I BELIEVE SO. BUT IF NOT, I'M HAPPY TO READ INTO THE RECORD WHAT IT IS.
JUDGE DAVILA: SURE. I'M SURE HE CAN DO THAT, AND IT WILL BE PUBLISHED WITH THAT DISPLAY.
MR. LEACH: THANK YOU, YOUR HONOR.
JUDGE DAVILA: AND OTHERWISE ADMITTED.
BY MR. DOWNEY:
MR. DOWNEY: I WAS DIRECTING YOUR ATTENTION TO THE BOTTOM EMAIL. THIS IS MS. DIGIAMO FORWARDING YOU AN UPDATE ON WHERE VARIOUS PROJECTS WERE; IS THAT RIGHT?
MR. DOWNEY: OKAY. LET'S GO TO THE BOTTOM OF PAGE 5, TOP OF PAGE 6. IF YOU SEE AT THE VERY BOTTOM OF 5 THERE'S A REFERENCE TO THE MAYO CLINIC, AND THEN A DISCUSSION ON THE NEXT PAGE. AND IF YOU SEE THE FIRST BULLET POINT READS, "EVALUATION OF THE THERANOS SYSTEM PERFORMED IN THE ENDOCRINOLOGY AND METABOLISM UNIT BY DR. VELLA (KEY INVESTIGATOR FOR DAIICHI-SANKYO HE ALSO WORKED WITH SUKI)." AND IS THIS SPECIFICALLY A REPORT ON WHERE THE WORK WITH MAYO WAS?
ELIZABETH A. HOLMES: YES. I THINK THIS IS A SUMMARY OF THAT VALIDATION AT MAYO, AND THEN A DISCUSSION OF THE NEXT PROGRAM WITH THEM.
MR. DOWNEY: OKAY. AND WHAT WAS SUMMARIZED AS TO THIS PROGRAM?
ELIZABETH A. HOLMES: SUSAN IS SAYING THAT THIS STUDY WAS RUN, SHE'S GIVING DETAILS ABOUT THE TIME POINTS THAT WERE TESTED, SHE SAID THAT DR. VELLA WAS IMPRESSED AND HE'S INTERESTED IN RUNNING ANOTHER STUDY AND PUBLISHING DATA LATER THAT YEAR.
MR. DOWNEY: OKAY. THEN DID YOU BELIEVE THAT THIS WAS A VALIDATION OF THERANOS'S TECHNOLOGY?
ELIZABETH A. HOLMES: I DID.
MR. DOWNEY: DID YOU DO FURTHER WORK FOR MAYO AFTER THIS DATE?
MR. DOWNEY: OKAY. LET ME ASK YOU NEXT ABOUT PFIZER. YOU CAN TAKE THAT DOWN. DO YOU RECALL THAT WE LOOKED ON FRIDAY AT THERANOS'S 2006 CONTRACT WITH PFIZER?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND WHAT WAS INTENDED UNDER THAT CONTRACT WHEN YOU SIGNED IT IN 2006?
ELIZABETH A. HOLMES: IT WAS A CONTRACT TO PERFORM A STUDY FOR PFIZER THAT WE WOULD WORK TOGETHER TO DEVELOP TO TEST AND VALIDATE THERANOS TECHNOLOGY.
MR. DOWNEY: OKAY. AND SPECIFICALLY, CAN YOU DESCRIBE WHAT THE NATURE OF THE WORK WAS AS TO HOW THE THERANOS TECHNOLOGY WOULD BE VALIDATED?
ELIZABETH A. HOLMES: YES. FIRST THERANOS HAD TO DEVELOP CERTAIN TESTS THAT WERE USEFUL IN CANCER PATIENTS. WE HAD TO VALIDATE THOSE CHEMISTRIES. THEN WE HAD TO USE THEM IN A STUDY WHERE WE WOULD TEST PATIENTS IN THEIR HOMES IN VERY REMOTE AREAS AND IN A CLINIC AND LOOK AT THAT DATA, AND ALSO LOOK AT HOW THAT DATA CHANGED OVER TIME, THE TRENDS IN THE DATA.
MR. DOWNEY: AND DID PFIZER AGREE TO PAY THERANOS IN CONNECTION WITH THE WORK THAT THERANOS DID?
MR. DOWNEY: AND DID THERANOS PREPARE A REPORT REFLECTING THE WORK THAT HAD BEEN DONE AND THE DATA THAT HAD BEEN GENERATED?
MR. DOWNEY: DID PFIZER PROVIDE FEEDBACK THAT YOU'RE AWARE OF ON THE REPORT?
ELIZABETH A. HOLMES: I DON'T THINK ON THE REPORT SPECIFICALLY, NO.
MR. DOWNEY: DO YOU RECALL THAT THERE WAS TESTIMONY DURING THE CASE FROM DR. SHANE WEBER?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND DO YOU RECALL THAT THAT WAS IN AND AROUND NOVEMBER OF 2008?
MR. DOWNEY: AFTER NOVEMBER 2008, DID YOU AND OTHERS AT THERANOS CONTINUE TO INTERACT WITH PFIZER ABOUT POTENTIAL WORK?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: LET ME ASK YOU TO LOOK AT -- THIS SHOULD BE IN YOUR -- LET ME SEE IF THIS IS HERE.
JUDGE DAVILA: ADRIANA (HANDING.)
MR. DOWNEY: MAY I APPROACH THE WITNESS, YOUR HONOR?
JUDGE DAVILA: YES.
BY MR. DOWNEY:
MR. DOWNEY: (HANDING.) IS 15041 AN EMAIL BETWEEN YOU AND AN INDIVIDUAL AT -- INDIVIDUALS AT PFIZER?
ELIZABETH A. HOLMES: I'M JUST FINDING IT. ONE SECOND. YES.
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15041.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15041 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: DO YOU SEE THAT AT THE TOP YOU ADDRESS THIS EMAIL TO A DAVID LESTER AT THERANOS AND CRAIG LIPSET. WHO WAS MR. LESTER?
ELIZABETH A. HOLMES: MR. LESTER HAD BEEN OUR POINT PERSON AT PFIZER WHO WAS NOW WORKING WITH US AT THERANOS.
MR. DOWNEY: HE CAME TO THERANOS AFTER HE WORKED AT PFIZER?
ELIZABETH A. HOLMES: HE DID.
MR. DOWNEY: OKAY. AND IT'S ALSO ADDRESSED TO CRAIG LIPSET. WHO IS CRAIG LIPSET?
ELIZABETH A. HOLMES: CRAIG LIPSET WAS ONE OF OUR POINT PEOPLE FOR THE PFIZER STUDY ITSELF.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT THE EMAIL AT THE BOTTOM OF PAGE 1. THIS IS AN EMAIL FROM CRAIG LIPSET AT PFIZER TO DAVID LESTER AT THERANOS. AND HE SAYS IN THE FIRST PARAGRAPH THAT, "WE ARE PURSUING SEVERAL POTENTIAL ENGAGEMENTS AS A RESULT OF THE RECENT MEETING TOGETHER. ONE PARTICULAR OPPORTUNITY HAS MOMENTUM, HOWEVER, AND SO I WOULD LIKE TO SUGGEST SOME QUICK FOLLOW-UP AND ENGAGEMENT WITH THE PRODUCT TEAM." DO YOU SEE THAT?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND THEN HE GOES ON TO DESCRIBE THE ENGAGEMENT, THE POTENTIAL ENGAGEMENT IN THE NEXT PARAGRAPH. DO YOU SEE THAT?
MR. DOWNEY: CAN YOU EXPLAIN WHEN HE SAYS "A TEAM DEVELOPING A MAB FOR IL-6 HAS MODELING NEEDS," AND THEN IF YOU SKIP THE NEXT SENTENCE AND SAY, "HOWEVER, THIS COULD PROVIDE A GOOD TIME CYCLE TO ENGAGE THE TEAM, DEVELOP A MODEL, AND IDENTIFY ANALYTICAL POTENTIAL." AND THE EMAIL GOES ON FROM THERE. WHAT DID YOU UNDERSTAND WAS BEING CONVEYED IN THESE PARAGRAPHS?
ELIZABETH A. HOLMES: DR. LIPSET IS RELAYING THAT THERE IS A NEW DRUG THAT PFIZER WAS INTERESTED IN WORKING WITH THERANOS ON AND THAT IT WOULD BE A GREAT PROGRAM TO DEVELOP A MODEL FOR, WHICH WAS OUR SOFTWARE THAT WE WERE BUILDING, AND THEN POTENTIALLY DO TESTING ON THROUGH THE THERANOS SYSTEM.
MR. DOWNEY: DID THERANOS CONTINUE TO ENGAGE -- DO YOU KNOW IF A CLINICAL TRIAL WOULD -- IF THERANOS ACTUALLY PARTICIPATED IN THE CLINICAL TRIAL THAT DR. LIPSET DESCRIBED IN THIS EMAIL?
ELIZABETH A. HOLMES: WE DID NOT.
MR. DOWNEY: DO YOU KNOW WHY NOT?
ELIZABETH A. HOLMES: PFIZER DECIDED NOT TO PURSUE THIS DRUG AFTER IT ACQUIRED OTHER DRUGS FROM ONE OF THE COMPANIES THAT THEY BOUGHT.
MR. DOWNEY: DID THERANOS CONTINUE TO TALK TO PFIZER ABOUT DOING ADDITIONAL WORK IN 2010 AND BEYOND?
MR. DOWNEY: LET ME ASK YOU TO LOOK AT EXHIBIT 15047. THAT WILL BE IN THE NOTEBOOK THAT IS MARKED AS VOLUME 2.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: IS THIS AN EMAIL BETWEEN, AMONG OTHERS, YOURSELF AND OTHERS AT PFIZER?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15047.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15047 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: DO YOU SEE IN THE TOP EMAIL JUST THAT THE SUBJECT WAS "FOLLOWING UP ON YOUR TECHNOLOGY"?
MR. DOWNEY: AND THEN LET'S GO TO THE BOTTOM EMAIL ON PAGE 1. AND THERE'S AN EMAIL THERE FROM A MORTEN SOGAARD. WHO IS MORTEN SOGAARD?
ELIZABETH A. HOLMES: HE WAS AN EXECUTIVE AT PFIZER.
MR. DOWNEY: AND WHAT ROLE DID HE PLAY THERE?
ELIZABETH A. HOLMES: I THINK HE WAS -- HAD BOTH A SCIENTIFIC AND A BUSINESS DEVELOPMENT TYPE BACKGROUND.
MR. DOWNEY: AND WHO ARE THE -- WHO IS HAKAN SAKUL IDENTIFIED IN THIS CC LINE?
ELIZABETH A. HOLMES: HE WAS ONE OF THE POINTS FOR OUR ORIGINAL PROGRAM WITH PFIZER.
MR. DOWNEY: OKAY. AND WHO WAS GREGORY NAEVE?
ELIZABETH A. HOLMES: I THINK A SCIENTIST AT PFIZER.
MR. DOWNEY: OKAY. AND IF YOU LOOK AT THE CONTENT OF THAT EMAIL MR. SOGAARD SAYS TO YOU, "THANK YOU FOR AN EXCITING AFTERNOON YESTERDAY. WE ARE VERY MUCH LOOKING FORWARD TO FURTHER INTERACTIONS. I WILL FOLLOW UP SEPARATELY WITH CHRISTIAN REGARDING A NEW 2-WAY CDA." DO YOU SEE THAT?
MR. DOWNEY: AND WHAT MEETING HAD OCCURRED ON WHICH MR. SOGAARD IS FOLLOWING UP?
ELIZABETH A. HOLMES: THIS IS A MEETING WITH PFIZER AROUND RUNNING CLINICAL TRIALS USING THE WELLNESS CENTERS THAT WE WERE PUTTING IN RETAIL THROUGH WALGREENS.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK UP TO THE MIDDLE EMAIL ON PAGE 1. AND THIS IS AN EMAIL FROM DR. SAKUL. NOW, DR. SAKUL, HAD HE BEEN INVOLVED IN THE VALIDATION STUDY THAT LED TO THE REPORT THAT YOU SUBMITTED?
ELIZABETH A. HOLMES: MY UNDERSTANDING IS YES.
MR. DOWNEY: ALL RIGHT. AND HE GOES ON TO SAY -- HE SAYS THAT HE IS ADDING HIS THANKS AS WELL. HE IS LEARNING ABOUT THE GREAT PROGRESS THAT THERANOS HAS MADE OVER THE YEARS AND HE HOPES THAT THEY WILL FIND A WAY TO WORK TOGETHER. DID YOU, COMING OUT OF THIS MEETING WITH THE PFIZER REPRESENTATIVES, CONTINUE TO EXPLORE THE POSSIBILITY OF ADDITIONAL WORK FOR PFIZER EVEN AS OF 2013 AND 2014?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: DID PFIZER CONTINUE TO INTERACT WITH THERANOS IN 2015?
MR. DOWNEY: LET ME ASK YOU TO LOOK AT 15039.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: IS THIS AN EMAIL BETWEEN YOU AND DR. LIPSET IN 2015?
MR. DOWNEY: I MOVE THE ADMISSION OF 15039.
MR. LEACH: 801, 802, YOUR HONOR. IF IT'S FOR A LIMITED PURPOSE, THAT'S FINE.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: MR. DOWNEY, ANY OBJECTIONS TO THIS COMING IN ON A LIMITED PURPOSE?
MR. DOWNEY: WELL, YOUR HONOR, FOR PRESENT PURPOSES, NO, NO OBJECTION.
JUDGE DAVILA: AND THIS IS IN REGARDS TO THE STATUS OF THE TECHNOLOGY AT THE TIME OF THIS EMAIL AS TO THIS WITNESS?
MR. DOWNEY: AS TO HER UNDERSTANDING OF PFIZER'S PERCEPTION OF THE STATUS OF THE TECHNOLOGY.
JUDGE DAVILA: ALL RIGHT. THIS EMAIL WILL BE ADMITTED, LADIES AND GENTLEMEN, NOT FOR THE TRUTH OF THE MATTER ASSERTED, BUT AS INDICATED, AS TO MS. HOLMES'S STATE OF MIND AS TO HER UNDERSTANDING OF PFIZER'S PERCEPTION OF THE TECHNOLOGY, THE THERANOS TECHNOLOGY. AND IT CAN BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15039 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: LET ME DIRECT YOUR ATTENTION TO THE EMAIL AT THE BOTTOM FROM MR. LIPSET TO YOU AT 6:24 P.M. AND IF YOU GO DOWN TO THE THIRD PARAGRAPH OF THAT EMAIL, HE PURPORTS THAT HE HAS BEEN WORKING WITH SOME OF OUR -- PFIZER'S R&D TEAMS ON STUDIES TO LEVERAGE WALGREENS IN-STORE INFRASTRUCTURE AS A CLINICAL TRIAL SITE. AND IS THAT A REFERENCE TO WHAT YOU DESCRIBED BEFORE?
MR. DOWNEY: AND THEN IN THE NEXT PARAGRAPH HE REFERS TO SOME OF THE TEAMS AT PFIZER IN PFIZER CONSUMER HEALTH. WHAT IS HE -- WHAT DID YOU UNDERSTAND THAT HE WAS TELLING YOU IN THAT PARAGRAPH?
ELIZABETH A. HOLMES: THAT THERE'S A TEAM OF PEOPLE IN THE CONSUMER DIVISION OF PFIZER, WHICH I UNDERSTOOD WORKS WITH DRUGS THAT ARE ON THE MARKET, THAT IS INTERESTED IN DOING LIPIDS AND CHOLESTEROL TESTING AS PART OF THIS CAMPAIGN.
MR. DOWNEY: OKAY. NOW, AS OF THE TIME THAT YOU WERE WORKING WITH PHARMACEUTICAL COMPANIES IN 2008 AND 2009, WAS THERANOS TECHNOLOGY USED TO ANALYZE IMMUNOASSAYS?
ELIZABETH A. HOLMES: WE RAN IMMUNOASSAYS ON OUR TECHNOLOGY, YES.
MR. DOWNEY: AND DID THERANOS LOOK DURING THAT PERIOD TO BE ABLE TO RUN METHODS THAT WOULD ALLOW IT TO RUN ASSAYS OTHER THAN IMMUNOASSAYS?
ELIZABETH A. HOLMES: WE DID.
MR. DOWNEY: AND CAN YOU REMIND US WHAT IMMUNOASSAYS ARE?
ELIZABETH A. HOLMES: YES. IT'S ONE OF THE METHODS THAT WE'VE BEEN TALKING ABOUT, WHICH IS A TYPE OF CHEMISTRY THAT IS USED TO MEASURE SMALL MOLECULES, PROTEINS, METABOLITES, ANTIBODIES, AND THE METHOD WORKS BY HAVING SOME TYPE OF ANTIBODY IN YOUR TEST THAT BINDS TO SOMETHING YOU WANT TO MEASURE IN SAMPLE AND THEN HAVING SOME TYPE OF SIGNAL GENERATED THAT CAN BE MEASURED BY A DETECTOR WHICH IS YOUR MEASUREMENT DEVICE.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT EXHIBIT 15023.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: WHAT IS EXHIBIT 15023?
ELIZABETH A. HOLMES: THIS IS AN EMAIL FROM GARY FRENZEL TO ME AFTER ONE OF OUR MEETINGS WITH DOD.
MR. DOWNEY: AND IS MR. FRENZEL AN EMPLOYEE AT THERANOS?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 15023.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 15023 WAS RECEIVED IN EVIDENCE.)
MR. DOWNEY: I'M INTERESTED IN THE BOTTOM EMAIL.
MR. DOWNEY: AND LOOKING AT THIS EMAIL, YOU MENTIONED THAT THIS -- THERE HAD BEEN A MEETING AT DOD. WHAT WAS THAT MEETING ABOUT?
ELIZABETH A. HOLMES: I'M JUST READING IT. I THINK THIS WAS RELATING TO WHAT WE WERE TALKING ABOUT EARLIER, MEASURING INFECTION IN TRAUMA PATIENTS.
MR. DOWNEY: OKAY. IF YOU LOOK AT THE THIRD SENTENCE THAT BEGINS, "THE COLONEL INTIMATED A DESIRE FOR OTHER TECH AS WELL... CYTOMETRY AND GC/MS. BOTH OF WHICH I WOULD LOVE FOR US TO MOVE TO IN FUTURE GENERATIONS. AS WELL AS PCR." CAN YOU EXPLAIN WHAT MR. FRENZEL IS PROPOSING IN THOSE SENTENCES?
ELIZABETH A. HOLMES: GARY IS SAYING HERE THAT AS WE GO FORWARD, ADDING ADDITIONAL METHODS, THE THREE METHODS HE'S TALKING ABOUT HERE ARE CYTOMETRY, GC/MS, AND PCR TO OUR SYSTEM IS SOMETHING THAT HE WOULD LOVE TO DO.
MR. DOWNEY: AND DID SCIENTISTS AND ENGINEERS AT THERANOS BEGIN EXPLORING WHETHER THAT COULD BE DONE IN 2009?
MR. DOWNEY: LET ME -- TO YOUR KNOWLEDGE, WAS DR. ROBERTSON INVOLVED WITH THOSE EFFORTS?
ELIZABETH A. HOLMES: HE WAS.
MR. DOWNEY: WHAT ROLE WAS HE PLAYING AT THE COMPANY AT THAT TIME IN 2009?
ELIZABETH A. HOLMES: DR. ROBERTSON WAS ONE OF OUR BOARD MEMBERS. HE WAS ALSO SERVING AS A CHIEF TECHNICAL ARCHITECT INTERNALLY.
MR. DOWNEY: OKAY. LET ME ASK YOU TO LOOK AT EXHIBIT 7087.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: IS THIS AN EMAIL BETWEEN DR. ROBERTSON AND YOURSELF DISCUSSING THERANOS'S TECHNOLOGIES IN 2009?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 7087.
MR. LEACH: ONE MOMENT, YOUR HONOR.
(PAUSE IN PROCEEDINGS.)
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7087 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: IF YOU WOULD LOOK AT THE BOTTOM EMAIL, HE SAYS, "WE HAD OUR FIRST GROUP MEETING TODAY TO START TALKING ABOUT ASSESSING NEW TECHNOLOGIES, THINKING AHEAD AND THINKING OUT OF THE BOX." AND HE GOES ON TO DESCRIBE PEOPLE'S ENTHUSIASM. WHAT DID YOU UNDERSTAND HIM TO BE TALKING ABOUT AT THIS POINT IN 2009?
ELIZABETH A. HOLMES: HE'S TALKING ABOUT OUR EVALUATION OF THE NEW TECHNOLOGIES WE WERE PURSUING FOR ADDING MULTIPLE METHODS TO OUR SYSTEM.
MR. DOWNEY: NOW, DID THERE COME A TIME IN EARLY 2010 WHEN THERANOS'S SCIENTISTS AND ENGINEERS TOLD YOU THAT THEY BELIEVED IT WAS FEASIBLE FOR THERANOS SYSTEMS TO BE CONFIGURED SO THAT THEY COULD RUN ANY BLOOD TEST?
MR. DOWNEY: LET ME ASK YOU TO LOOK AT EXHIBIT 7096.
ELIZABETH A. HOLMES: OKAY.
MR. DOWNEY: CAN YOU IDENTIFY 7096?
ELIZABETH A. HOLMES: YES. IT'S AN EMAIL FROM DR. GIBBONS TO ME ABOUT THE CAPABILITIES OF OUR SYSTEM.
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF 7096.
MR. LEACH: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7096 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: DO YOU SEE HERE HE'S SAYING "I'D LIKE TO PRESENT" -- THIS IS IN JANUARY OF 2010; CORRECT?
ELIZABETH A. HOLMES: IT IS.
MR. DOWNEY: IN THE SECOND SENTENCE WHEN HE SAYS, "I BELIEVE THE TECHNOLOGY HAS THE POTENTIAL FOR RAPID EXPANSION OF OUR ABILITY TO DO GENERAL CHEMISTRY ASSAYS AND EXISTING COLORIMETRIC ELISA'S (REDUCING ASSAY DEVELOPMENT TIME)." AND HE GOES ON TO DESCRIBE WHAT THE SAMPLE WOULD BE AND OTHER TECHNOLOGY. WHAT DID YOU UNDERSTAND THAT DR. GIBBONS WAS CONVEYING TO YOU IN THIS EMAIL?
ELIZABETH A. HOLMES: DR. GIBBONS IS CONVEYING THAT THERE IS DATA THAT HAS BEEN GENERATED THAT REFLECTS OUR ABILITY TO EXPAND EXISTING CAPABILITIES FOR GENERAL CHEMISTRY AND ELISA'S, WHICH ARE THE IMMUNOASSAYS, ON OUR SYSTEM.
MR. DOWNEY: AND DID THERE COME A TIME IN EARLY 2010 WHEN DR. GIBBONS AND OTHERS MADE A PRESENTATION TO YOU ABOUT THE EXPANSION OF THERANOS SYSTEMS CAPACITY?
ELIZABETH A. HOLMES: THEY DID.
MR. DOWNEY: LET ME ASK YOU TO LOOK AT EXHIBIT 7098. IS THIS A POWERPOINT THAT WAS USED IN CONNECTION WITH THAT PRESENTATION TO YOU ABOUT THE CAPABILITIES OF THERANOS TECHNOLOGY?
MR. DOWNEY: YOUR HONOR, I MOVE THE ADMISSION OF EXHIBIT 7098.
MR. LEACH: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7098 WAS RECEIVED IN EVIDENCE.)
BY MR. DOWNEY:
MR. DOWNEY: GO TO SLIDE 2. THIS IS LABELLED "SYSTEM COMPONENT REQUIREMENTS AND SELECTION SYSTEM 4.0." DO YOU SEE THAT?
MR. DOWNEY: AND WHAT DID SYSTEM 4.0 REFER TO?
ELIZABETH A. HOLMES: IT WAS THE NEXT GENERATION SYSTEM FROM OUR 3 SERIES SYSTEM.
MR. DOWNEY: AND LET'S GO TO THE NEXT SLIDE. CAN YOU TAKE US THROUGH THE ENTRIES ON THE NEXT SLIDE AND EXPLAIN WHAT IS BEING CONVEYED IN THIS POWERPOINT SLIDE?
ELIZABETH A. HOLMES: YES. DR. GIBBONS IS SAYING THAT OUR 4 SERIES SYSTEM WILL BE CAPABLE OF PERFORMING ANY MEASUREMENT IN A DISTRIBUTED TEST SETTING, MEANING IN THE FIELD OR OUTSIDE OF THE TRADITIONAL LAB. HE'S SAYING THAT IT WILL INCLUDE SEVERAL MEASUREMENT TECHNOLOGIES. SO MULTIPLE METHODS. HE'S SAYING THAT THE SYSTEM WILL BE BASED ON THE EXISTING CARTRIDGE AND DEVICE. AND HE'S COMMENTING THAT IT WILL BE AN OPEN ARCHITECTURE. SO THIS GETS TO THE POINT THAT WE WERE TALKING ABOUT EARLIER, WHICH IS WITH A ROBOT, YOU CAN PROGRAM IT TO RUN ANY TEST AS OPPOSED TO BEING FIXED IN WHAT YOU COULD RUN, LIKE THE EXAMPLE OF A GLUCOSE METER. AND HE'S SAYING THAT THE TOTAL MEASUREMENTS ON A SAMPLE WILL BE INCREASED FROM THE SIX THAT WE WERE RUNNING AT THAT TIME TO, HE'S SUGGESTING 2- TO 3-FOLD, 15 ASSAYS.
MR. DOWNEY: SO 15 ASSAYS MIGHT BE PLACED ON ONE CARTRIDGE AND RUN AT THE SAME TIME?
MR. DOWNEY: AND WHEN HE SAYS IN THE FIRST BULLET POINT "ANY MEASUREMENT," WHAT IS THAT A REFERENCE TO?
ELIZABETH A. HOLMES: HE'S TALKING ABOUT THE FACT THAT THE 4 SERIES SYSTEM WILL BE CAPABLE OF RUNNING ANY TEST.
MR. DOWNEY: LET ME ASK YOU TO GO FORWARD TO SLIDE 5. IT SAYS "CANDIDATE TECHNOLOGIES." DO YOU SEE THAT?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: CAN YOU EXPLAIN WHAT THIS IS?
ELIZABETH A. HOLMES: THIS IS AN OVERVIEW OF THE METHODS THAT DR. GIBBONS WAS SUGGESTING THAT WE REVIEW AS POSSIBLE METHODS TO RUN ON THE SYSTEM.
MR. DOWNEY: OKAY. LET ME ASK YOU NOW TO LOOK AT SLIDE 6. I'M SORRY, SLIDE 7. IT'S LABELLED "PROPOSAL FOR THE BASIS OF SYSTEM 4.0." DO YOU SEE THAT?
ELIZABETH A. HOLMES: I DO.
MR. DOWNEY: AND WHAT DOES THIS SLIDE CONVEY?
ELIZABETH A. HOLMES: I'M JUST LOOKING AT IT. IT CONVEYS DR. GIBBONS'S PROPOSAL FOR THE SYSTEM 4.0 DESIGN, OR ARCHITECTURE.
MR. DOWNEY: AND DOES IT SET FORTH THE STEPS THAT ARE BEING TAKEN TO DEVELOP THAT TECHNOLOGY?
ELIZABETH A. HOLMES: IT DOES.
MR. DOWNEY: AS A RESULT OF THE PRESENTATION THAT YOU RECEIVED IN FEBRUARY OF 2010 REGARDING THERANOS'S TECHNOLOGY, WHAT DID YOU UNDERSTAND THAT THE TECHNOLOGY COULD DO WITH RESPECT TO BLOOD TESTS?
ELIZABETH A. HOLMES: I UNDERSTOOD THAT THE 4 SERIES COULD DO ANY BLOOD TEST.
MR. DOWNEY: YOUR HONOR, I'LL BE MOVING TO A SLIGHTLY DIFFERENT AREA, SO MAYBE NOW IS A GOOD TIME TO END FOR TODAY.
JUDGE DAVILA: WELL, LET'S DO THAT. WE'RE ENDING TODAY, YOU RECALL, AT 1:00 P.M. WE'LL START TOMORROW AT 9:00 A.M. I THINK TOMORROW WILL BE A FULL DAY, LADIES AND GENTLEMEN. WE'LL GO UNTIL 4:00 TOMORROW, 4:00 O'CLOCK. SO WE'LL BREAK TODAY. LET ME REMIND YOU OF THE ADMONITION. PLEASE DO NOT DO ANY INDEPENDENT RESEARCH, DO NOT READ, DISCUSS, OR LISTEN TO IN ANY WAY OR TRY TO BECOME INVOLVED WITH ANY INFORMATION ABOUT THIS CASE. TOMORROW I'LL ASK YOU IF THAT HAS OCCURRED. SO HAVE A GOOD EVENING, LADIES AND GENTLEMEN. WE'LL SEE YOU TOMORROW MORNING AT 9:00 A.M. MS. HOLMES, YOU'LL RETURN TOMORROW MORNING AT 9:00 A.M., PLEASE.
ELIZABETH A. HOLMES: I WILL, YES.
(JURY OUT AT 1:00 P.M.)
JUDGE DAVILA: YOU CAN STAND DOWN. THANK YOU. PLEASE BE SEATED. THANK YOU. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR THE DAY. MR. LEACH, DID YOU WANT TO BRING SOMETHING UP NOW? ALL COUNSEL ARE PRESENT, MS. HOLMES IS PRESENT. THE JURY HAS LEFT THE COURTROOM.
MR. LEACH: THE ISSUE IS SOMEWHAT MOOT, YOUR HONOR. THE GOVERNMENT DIDN'T RAISE IT BEFORE THE EXAMINATION, BUT TODAY THE COURT ADMITTED EXHIBITS 15023, 15039, 15041, 15044, 15045, AND 15047. THESE ALL BEAR BATES NUMBERS HOLMES 0019083 THROUGH 0019267. ALL OF THESE WERE PRODUCED FOR THE FIRST TIME IN DISCOVERY SOMETIME AFTER 9:00 O'CLOCK ON SATURDAY. WE HAD INTENDED TO MOVE TO EXCLUDE THEM ON THAT BASIS AT THE OUTSET OF THE TESTIMONY, BUT ELECTED, GIVEN WE HAD A LONG BREAK THIS MORNING, WE CHOSE NOT TO DO THAT. WE DO CONTINUE TO HAVE CONCERNS ABOUT THE PROVIDENCE OF SOME OF THESE DOCUMENTS AND THE LATENESS WITH WHICH THEY'RE COMING TO THE COURT IN VIOLATION OF THE RULE 16 DEADLINE, BUT WE MADE A CHOICE NOT TO OBJECT. I JUST WANTED TO MAKE A RECORD OF THAT.
JUDGE DAVILA: ALL RIGHT. THANK YOU. MR. DOWNEY, DO YOU WANT TO SPEAK FOR YOUR TEAM?
MR. DOWNEY: YOUR HONOR, I DO, AND I'M GLAD THAT MR. LEACH HAS NO MOTION AT THIS TIME, NOR DO I HAVE A MOTION ABOUT THE 2000 DOCUMENTS WHICH WERE PRODUCED TO US AND USED AS EXHIBITS WITHIN ABOUT 48 HOURS DURING THE GOVERNMENT'S CASE. IT'S A REALITY OF TRIAL THAT SOME EXHIBITS WILL BE DISCLOSED LATE. MORE IMPORTANTLY AND MORE FUNDAMENTALLY, RULE 16, IN THE CONTEXT OF A CRIMINAL CASE, AS THE COURT WELL KNOWS, IS NOT A DISCOVERY OPPORTUNITY FOR THE GOVERNMENT. WHEN WE KNOW THAT WE ARE GOING TO INTRODUCE A DOCUMENT IN OUR CASE-IN-CHIEF, SO SOME DOCUMENTS IN CONNECTION WITH THIS DEFENDANT'S TESTIMONY, WE ARE PRODUCING THAT. SO I DON'T -- IT'S NOT WELL TAKEN BY ME, THE SUGGESTION THAT THESE DOCUMENTS ARE INTENTIONALLY WITHHELD OR NOT. I TOLD MR. LEACH I WOULD LOOK AT DOCUMENTS ON SATURDAY, I WOULD PRODUCE THEM TO HIM. I DID THAT. HE'S HAD 36 HOURS, WHICH IS A LOT MORE THAN I NORMALLY HAD WHEN HE PRODUCED DOCUMENTS TO ME AT, YOU KNOW, THE NIGHT BEFORE ON MANY ISSUES. AND THAT'S -- I'M NOT FAULTING HIM. I ONLY MENTION IT BECAUSE THIS IS BEING RAISED IN OUR CASE. I DON'T THINK -- IN FAIRNESS, I DON'T THINK YOU HEARD A LOT OF COMPLAINTS OUT OF US ALONG THESE LINES DURING THE GOVERNMENT'S CASE.
MR. LEACH: RESPECTFULLY, YOUR HONOR, I AM NOT COMPLAINING ABOUT ADDING AN EXHIBIT THAT WAS PRODUCED IN DISCOVERY TO THE EXHIBIT LIST. THE GOVERNMENT HAS DONE THAT. IT HAPPENS. WE UNDERSTAND THAT. WHAT I'M TALKING ABOUT IS SOMETHING VERY DIFFERENT. THESE ARE RULE 16 DOCUMENTS THAT HAVE NOT BEEN PRODUCED IN DISCOVERY AND THE FIRST TIME THE GOVERNMENT IS GETTING THEM IS THE NIGHT BEFORE OR THE WEEKEND OF THE TESTIMONY. SO I THINK MR. DOWNEY, RESPECTFULLY, IS COMPARING APPLES TO ORANGES. I UNDERSTAND THAT PEOPLE ADD EXHIBITS TO AN EXHIBIT LIST LATE IN THE MIDDLE OF TRIAL. I JUST THINK THIS IS FUNDAMENTALLY DIFFERENT. I ALSO AM A LITTLE SKEPTICAL THAT THESE ARE BEING FOUND AT THE LAST MINUTE OR SOMEHOW THERE'S NOT A LITTLE BIT OF STRATEGY IN WHAT IS BEING PROVIDED TO THE GOVERNMENT. I WOULD NOTE THAT 15023, 15039, AND 15041 ALL HAVE LOWER EXHIBIT NUMBERS THAN DOCUMENTS THAT WERE IN YOUR HONOR'S BINDER ON FRIDAY. I THINK THESE WERE DOCUMENTS THAT HAD BEEN IDENTIFIED WHICH WERE INTENDED FOR THE CASE-IN-CHIEF, AND THEY'RE SLOW ROLLING TO THEM, TO US. RULE 16 -- THERE WAS AN ORDER. THEY WERE ORDERED TO GIVE RULE 16 TO THE GOVERNMENT. THEY'RE DOING IT THE DAY BEFORE, THE NIGHT OF. THIS IS DIFFERENT FROM ADDING SOMETHING THAT WAS PRODUCED IN DISCOVERY OR THAT'S A 302 THAT IS CREATED THE NIGHT BEFORE BECAUSE YOU INTERVIEWED THE WITNESS AGAIN. SO I THINK IT'S A LITTLE BIT OF APPLES AND ORANGES, AND ALL I'M ASKING FOR IS THAT THEY HAVE A LIST, THEY HAVE A MASTER LIST, THEY KNOW WHAT THEY'RE PRESENTING TO THEIR CLIENT, AND WE JUST WANT IT TIMELY.
JUDGE DAVILA: MR. DOWNEY?
MR. DOWNEY: I HAVE REALLY NOTHING TO ADD, YOUR HONOR. THE, THE -- I DON'T THINK THE COURT BELIEVES THAT RULE 16 GENERALLY IS A DISCOVERY DEVICE FOR THE GOVERNMENT COMPARABLE TO A DISCOVERY DEVICE IN A CIVIL CASE. THE DEFENDANT IS TESTIFYING. WHETHER THE DEFENDANT TESTIFIES, AS THE COURT WELL KNOWS, COULD BE QUITE A LATE JUDGMENT AT THE END OF THE GOVERNMENT'S CASE. THE GOVERNMENT'S CASE ENDED FRIDAY. MR. LEACH CAME TO ME AND CONFERRED WITH ME ABOUT A COUPLE OF EXHIBITS THAT WERE USED ON FRIDAY. I TOLD HIM I WOULD LOOK AT EXHIBITS THAT MIGHT BE USED, WHICH -- AND I TRIED TO COMPARE THEM TO WHAT HAD AND HAD NOT BEEN PRODUCED, AND I PRODUCED THEM TO HIM SATURDAY NIGHT. I DON'T KNOW, AND THE WITNESS WON'T BE ON CROSS-EXAMINATION FOR, YOU KNOW, SEVEN DAYS. I THINK THAT'S A VERY DIFFERENT SITUATION FROM THE ONE THAT WE FACED IN THE GOVERNMENT'S CASE. AND AGAIN, I'M NOT FAULTING HIM FOR THAT.
JUDGE DAVILA: ALL RIGHT. THANK YOU. MR. LEACH, ANYTHING FURTHER?
MR. LEACH: NOTHING FURTHER, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU FOR BRINGING THIS TO MY ATTENTION. IT JUST SPEAKS TO THE NATURE OF TRIALS. I APPRECIATE THE DEFENSE LOOKING AT THEIR FILES AND PROVIDING INFORMATION ACCORDINGLY TO THE GOVERNMENT SUCH THAT THE TRIAL CAN CONTINUE TO PROCEED IN AN EFFICIENT MANNER.
MR. DOWNEY: WHICH WE WILL CONTINUE TO DO, YOUR HONOR.
JUDGE DAVILA: THANK YOU. LET ME -- I DO WANT TO RAISE ANOTHER TOPIC. IT'S SOMETHING THAT HAS BECOME PERHAPS AN OLD AND FAMILIAR REFRAIN, AND MAYBE THAT'S THE APPROPRIATE TERM, BUT WE ARE RECEIVING INFORMATION FROM OUR JURY THAT KEYBOARD NOISE HAS INCREASED AGAIN, AND WE DON'T WANT TO DISTRACT -- PERHAPS IT SOUNDS A LITTLE RIDICULOUS WHY THE COURT KEEPS TALKING ABOUT LOUD KEYBOARDS. I DO IT ON BEHALF OF THE JURY, AND THE JURY SPEAKS THROUGH OUR COURTROOM DEPUTY, AND THEY HAVE REPORTED THAT KEYBOARD NOISE HAS INCREASED. THE DEFENDANT IS ON THE STAND NOW. IT'S A CRITICAL PART OF THE CASE. I'M GOING TO ASK FOLKS TO PLEASE, PLEASE, I UNDERSTAND YOUR DESIRE, YOUR NEED, YOUR OBLIGATIONS TO PERHAPS REPORT OR IN SOME WAY MEMORIALIZE THESE PROCEEDINGS, BUT YOU NEED TO DO IT IN A RESPECTFUL MANNER, PLEASE. WE HAVE AN OVERFLOW ROOM. IF YOU FEEL YOU CANNOT, CANNOT KEEP THE NOISE LEVEL DOWN, THEN I'M GOING TO ASK YOU TO SELF-POLICE INITIALLY AND GO TO THE OVERFLOW ROOM.
IF THAT DOESN'T WORK, IF IT CONTINUES TO BE A DISRUPTION FOR OUR JURY, I'M GOING TO BE FORCED TO ASK THOSE INDIVIDUALS TO LEAVE THE COURTROOM AND ENGAGE SOMEWHERE ELSE. IT'S AN IMPORTANT ISSUE TO THE GOVERNMENT, IT'S CERTAINLY AN IMPORTANT ISSUE TO THE DEFENSE THAT THE JURY BE ABLE TO CONCENTRATE FULLY, FULLY ON THE EVIDENCE WITHOUT BEING DISTRACTED. IT COULD BE KEYBOARD NOISE. IF IT WERE SOMEBODY CHEWING GUM, IF IT WERE SOMEBODY MAKING SOME KIND OF NOISE OR DISTRACTION TO THE JURY, I WOULD BE SIMILARLY CONCERNED. SO I'M NOT PICKING ON ANYONE. I'M NOT TRYING TO SINGLE ANYONE OUT. I GUESS I'M JUST ASKING FOR SOME RECIPROCAL RESPECT TO THE PROCEEDINGS. WE'LL JUST DO WHAT WE HAVE TO DO TO KEEP THE PROCEEDINGS APPROPRIATE FOR OUR JURY AND FOR ALL PARTICIPANTS. SO THANK YOU VERY MUCH. LET ME THANK THOSE IN ADVANCE WHO WILL ACCOMMODATE THIS. AND LET ME ALSO THANK THOSE OF YOU WHO HAVE KEYBOARDS, LAPTOPS WHO ARE, WHO ARE DOING YOUR BEST TO KEEP SILENT AND TO KEEP YOUR TYPING AT A LOW LEVEL. I APPRECIATE THAT. THESE LAWYERS APPRECIATE IT, AND THE JURY APPRECIATES IT. I KNOW IT CAN BE DONE. MANY OF YOU ARE DOING THAT. SO I HOPE THOSE WHO AREN'T WILL MODEL THEIR BEHAVIOR AFTER THOSE WHO ARE. ANYTHING FURTHER BEFORE WE BREAK?
MR. LEACH: NO, YOUR HONOR. THANK YOU.
MR. DOWNEY: NOT FROM THE DEFENSE.
JUDGE DAVILA: ALL RIGHT. THANK YOU. WE'LL SEE YOU TOMORROW MORNING.
COURT CLERK: COURT IS ADJOURNED.
(COURT ADJOURNED AT 1:09 P.M.)