Constance Cullen — Direct/Cross
662 linesDIRECT EXAMINATION BY MR. SCHENK:
MR. SCHENK: DR. CULLEN, IF YOU ARE FULLY VACCINATED AND WITH THE COURT'S PERMISSION, YOU MAY TESTIFY WITHOUT A MASK ON IF YOU'RE COMFORTABLE.
CONSTANCE CULLEN: YES.
MR. SCHENK: THANK YOU. I WILL DO THE SAME. DID YOU USED TO WORK FOR A COMPANY CALLED SCHERING-PLOUGH?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHEN YOU WORKED THERE, DID YOU HAVE THE OPPORTUNITY TO WORK WITH ANOTHER COMPANY CALLED THERANOS?
CONSTANCE CULLEN: YES.
MR. SCHENK: DO YOU REMEMBER ABOUT WHAT YEAR THAT WAS?
CONSTANCE CULLEN: YES. IT WAS 2009.
MR. SCHENK: WOULD YOU MIND PULLING THE MICROPHONE A LITTLE BIT CLOSER TO YOU?
CONSTANCE CULLEN: SURE. IT WAS 2009.
MR. SCHENK: THANK YOU. WE'LL COME BACK TO THAT IN JUST A MOMENT. WILL YOU SUMMARIZE YOUR EDUCATIONAL BACKGROUND, PLEASE, FOR THE JURY?
CONSTANCE CULLEN: YES. I HAVE A PH.D. IN MOLECULAR IMMUNOLOGY AND A BACHELOR'S DEGREE IN MICROBIOLOGY.
MR. SCHENK: THANK YOU. AND WE KNOW YOU WORKED FOR SCHERING-PLOUGH. WHEN WAS THAT? WHEN DID YOU WORK FOR SCHERING?
CONSTANCE CULLEN: I BEGAN WORKING FOR SCHERING-PLOUGH IN 1996, AND MY SERVICE ENDED IN 2016.
MR. SCHENK: FROM 1996 TO 2016?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND --
CONSTANCE CULLEN: I'M SORRY, I JUST WANTED TO CLARIFY. SCHERING-PLOUGH WAS ACQUIRED BY MERCK AT THE END OF 2009.
MR. SCHENK: SO YOU'RE INCLUDING A PERIOD OF TIME WHEN YOU WERE DOING THE SAME OR SIMILAR WORK, BUT NOW FOR A COMPANY CALLED MERCK?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: I SEE. MUCH OF YOUR TESTIMONY TODAY IS GOING TO FOCUS ON THE TIMEFRAME FROM ABOUT 2009 TO 2010. WOULD YOU TELL THE JURY WHAT YOU WERE DOING FOR SCHERING-PLOUGH AND MERCK AT THAT TIME?
CONSTANCE CULLEN: YES. I WAS THE DIRECTOR OF WHAT IS CALLED THE BIOANALYTICAL LABORATORY. SO MY LABORATORY WAS RESPONSIBLE FOR DEVELOPING AND VALIDATING ASSAYS FOR MEASUREMENT OF DRUG LEVELS, WHAT WE CALL BIOMARKERS, SO MARKERS OF DRUG EFFICACY AND DRUG ANTIBODIES IN THE CASE OF DEVELOPMENT OF PROTEIN-BASED THERAPEUTICS.
MR. SCHENK: OKAY. WOULD YOU MIND EXPLAINING THAT LAST PART? PROTEIN-BASED, WHAT IS THAT?
CONSTANCE CULLEN: SO THERE ARE ESSENTIALLY TWO BASIC CATEGORIES OF DRUGS. ONE IS REFERRED TO GENERALLY IN THE FIELD AS SMALL MOLECULES, SO ASPIRIN IS THE CLASSIC EXAMPLE OF A SMALL MOLECULE DRUG. THE OTHER CATEGORY OF DRUG IS WHAT WE CALL LARGE MOLECULES, SO THOSE TEND TO BE PROTEIN-BASED MONOCLONAL ANTIBODY. A WELL-KNOWN EXAMPLE OF A PROTEIN-BASED DRUG WOULD BE HUMIRA.
MR. SCHENK: YOU ALSO DESCRIBED PART OF YOUR JOB BEING TO DETERMINE THE EFFICACY OF DRUGS. WHAT DOES THAT MEAN?
CONSTANCE CULLEN: SO ONE USES A VARIETY OF DIFFERENT MEASUREMENTS TO DETERMINE WHETHER A DRUG IS WORKING IN THE PATIENT POPULATION THAT IT IS BEING TESTED IN. SOME OF THOSE TESTS ARE MEASURING THE ACTUAL DRUG LEVELS IN PATIENT BLOOD SAMPLES OR MEASURING OTHER WELL-KNOWN CHARACTERIZED MARKERS OF THEIR DISEASE STATE.
MR. SCHENK: YOU SAID YOU BECAME FAMILIAR WITH A COMPANY CALLED THERANOS. WAS THAT AROUND THE 2009 TIMEFRAME?
CONSTANCE CULLEN: YES, IT WAS.
MR. SCHENK: DO YOU REMEMBER THE CIRCUMSTANCES WHEN -- WHAT CAUSED YOU TO BECOME FAMILIAR WITH THERANOS?
CONSTANCE CULLEN: SURE. YES. SO WITHIN SCHERING-PLOUGH MY BOSS HAD ASKED ME TO EVALUATE THE TECHNOLOGY. THIS WAS DONE AT THE REQUEST OF THE HEAD OF OUR EARLY CLINICAL RESEARCH ORGANIZATION, AND THEY WERE INTERESTED IN THIS TECHNOLOGY BECAUSE THE CLAIM WAS THAT IT WOULD FACILITATE AND EXPEDITE TESTING OF DRUGS IN CLINICAL TRIALS.
MR. SCHENK: CAN WE FILL IN SOME NAMES. YOU FIRST STARTED BY SAYING YOUR BOSS.
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHO IS THAT PERSON?
CONSTANCE CULLEN: HIS NAME IS STEVE FARRAND.
MR. SCHENK: DO YOU MIND SPELLING THE LAST NAME FOR US, PLEASE?
CONSTANCE CULLEN: F-A-R-R-A-N-D.
MR. SCHENK: OKAY. AND I THINK IN YOUR DESCRIPTION YOU DESCRIBED ANOTHER INDIVIDUAL. WHO WAS THAT?
CONSTANCE CULLEN: HIS NAME WAS JIM MCLEOD, M-C-C-L-E-O-D, I THINK.
MR. SCHENK: OKAY. AND WHAT WAS MR. MCLEOD'S ROLE AGAIN IN YOU BECOMING INVOLVED IN THERANOS?
CONSTANCE CULLEN: YES. SO HE WAS THE LEADER OF WHAT WE CALLED AN EARLY CLINICAL RESEARCH AND EXPERIMENTAL MEDICINE GROUP. SO THAT GROUP WAS CHARGED WITH THE EARLIEST CLINICAL STUDIES, AND TO MAKE INITIAL ASSESSMENTS OF WHETHER OR NOT THE DRUGS WERE GOING TO BE GOOD ENOUGH TO BE PURSUED IN ADDITIONAL CLINICAL STUDIES.
MR. SCHENK: I SEE. NOW, IF YOU WOULD EXPLAIN TO ME WHERE YOU FIT INTO THIS? YOU DESCRIBED MR. MCLEOD'S ROLE. HOW DID YOU GET INTO THIS THERANOS WORK?
CONSTANCE CULLEN: SO, I MEAN, THE REQUEST WAS MADE, AS I MENTIONED, BY MY BOSS AND JIM MCCLEOD. THEY WERE INTERESTED IN EVALUATING THE TECHNOLOGY. BECAUSE MY LABORATORY HAD HISTORICALLY DONE SIMILAR TYPES OF ASSAYS, THEY ASKED ME TO PARTICIPATE IN EVALUATING THE TECHNOLOGY.
MR. SCHENK: OKAY. AND WHAT DOES "EVALUATING THE TECHNOLOGY" MEAN?
CONSTANCE CULLEN: SO WE ACTUALLY DID BETA TESTING. WE HAD RECEIVED TWO INSTRUMENTS FROM THERANOS. IN ADDITION, I TRAVELLED WITH A GROUP OF COLLEAGUES ON A DUE DILIGENCE VISIT TO THE THERANOS SITE.
MR. SCHENK: OKAY. AND WERE THOSE TWO SEPARATE PROJECTS, WHAT YOU DESCRIBED AS BETA TESTING, AND THEN THE TRAVEL TO THERANOS?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHAT WORK WAS DONE THAT CAUSED YOU TO TRAVEL TO THERANOS? WHAT WAS THAT PROJECT?
CONSTANCE CULLEN: IT WASN'T NECESSARILY RELATED TO THE WORK. IT WAS JUST A PART OF EVALUATION OF ANY NEW TECHNOLOGY THAT MIGHT BE BROUGHT INTO THE COMPANY.
MR. SCHENK: I SEE. SO THERANOS PROVIDED SOME DEVICES TO YOU; IS THAT RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: AND WHERE WERE YOU? WHAT STATE WERE YOU IN WHEN THAT HAPPENED?
CONSTANCE CULLEN: IN NEW JERSEY.
MR. SCHENK: SO THERANOS PROVIDED SOME DEVICES TO YOU IN NEW JERSEY, AND YOU ALSO HAD THE OPPORTUNITY TO TRAVEL TO CALIFORNIA; IS THAT RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: THANK YOU. YOUR HONOR, MAY I APPROACH?
JUDGE DAVILA: YES.
MR. SCHENK: THANK YOU (HANDING).
MR. SCHENK: DR. CULLEN, I'VE HANDED YOU A BINDER OF DOCUMENTS, AND I'LL ASK YOU TO OPEN IT AND TURN TO TAB 188. YOUR HONOR, THE GOVERNMENT OFFERS 188 PURSUANT TO A STIPULATION OF THE PARTIES.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 188 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: DR. CULLEN, THE EXHIBIT AT 188 SHOULD ALSO IN A MOMENT APPEAR ON THE SCREEN IN FRONT OF YOU, AND WHICHEVER ONE IS EASIER FOR YOU TO FOLLOW ALONG WITH, FEEL FREE. IN THE EMAIL THAT WE'RE LOOKING AT, IF WE LOOK FROM THE BOTTOM UP, IT LOOKS LIKE IT'S AN EMAIL FROM MS. HOLMES TO YOU IN FEBRUARY OF 2009. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND MS. HOLMES REFERENCES A CALL WITH JIM MCLEOD. THAT'S THE INDIVIDUAL THAT YOU WERE JUST SPEAKING OF?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: AND SHE ASKS FOR A CONVENIENT TIME TO TALK TO YOU. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THEN IN THE TOP EMAIL, ANOTHER EMAIL FROM MS. HOLMES TO YOU, NOW WE'RE AT THE BEGINNING OF MARCH OF 2009, AND MS. HOLMES SAYS, "TAKE A LOOK AT THE ATTACHED PER OUR CONVERSATION. "IF WE GO DOWN THIS PATH, THERE ARE TWO SETS OF DOCUMENTS THAT WILL COMPLEMENT THIS SUMMARY - ONE IS A DETAILED PROTOCOL FOR RUNNING THESE EXPERIMENTS. THE OTHER IS THE CARTRIDGE INSERTS." HELP ME UNDERSTAND THE REFERENCE TO A DETAILED PROTOCOL FOR RUNNING THESE EXPERIMENTS.
CONSTANCE CULLEN: SO A PROTOCOL IS JUST ESSENTIALLY A WRITTEN DOCUMENT THAT DICTATES WHAT YOU'RE GOING TO DO TO EVALUATE THE INSTRUMENT OR THE TECHNOLOGY THAT YOU'RE TESTING. IT GENERALLY COMES WITH A PREDETERMINED ACCEPTANCE CRITERIA AGAINST WHICH YOU EVALUATE THE RESULTS ONCE THEY'RE AVAILABLE.
MR. SCHENK: I SEE. AND IF YOU'LL TURN TO THE SECOND PAGE, THE ATTACHMENT, IS THIS THE BEGINNING OF THE PROTOCOL?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND IN THE HEADING SECTION ON THE SECOND LINE THERE'S A REFERENCE TO CRP, IL-6, AND TNF-A MULTIPLEX. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. SCHENK: HELP ME UNDERSTAND, WHAT IS THAT A REFERENCE TO?
CONSTANCE CULLEN: SO CRP STANDS FOR C REACTIVE PROTEIN, IL-6 STANDS FOR INTERLEUKIN 6, AND TNF-A STANDS FOR TUMOR NECROSIS FACTOR ALPHA. THOSE ARE MARKERS OF INFLAMMATION THAT PEOPLE OFTEN MEASURE TO UNDERSTAND WHETHER OR NOT A PATIENT IS HAVING AN INFLAMMATORY RESPONSE, AND IN OUR CASE WHETHER OR NOT A DRUG THAT WAS DELIVERED TO A PATIENT WAS EFFICACIOUS IN REDUCING THESE INFLAMMATORY MARKERS.
MR. SCHENK: OKAY. AND THEN THE WORK MULTIPLEX, WHAT DOES THAT MEAN?
CONSTANCE CULLEN: SO MULTIPLEX MEANS THAT INSTEAD OF DEVELOPING EACH OF THOSE THREE TESTS INDIVIDUALLY, ONE COULD DEVELOP THEM SIMULTANEOUSLY SUCH THAT A SINGLE SAMPLE WOULD BE SUFFICIENT TO MEASURE ALL THREE.
MR. SCHENK: I SEE. A MOMENT AGO YOU TOLD ME THAT THERE WERE SORT OF TWO PROJECTS THAT SCHERING-PLOUGH WAS DOING. ONE WAS A BETA TEST AND THERE WAS ANOTHER ONE. WHICH ONE IS THIS?
CONSTANCE CULLEN: THIS WOULD HAVE BEEN THE VALIDATION, SO INDEPENDENT OF THE BETA TEST.
MR. SCHENK: OKAY. SO THE BETA TEST, IS THAT THE ONE WHERE THERANOS SENT DEVICES TO NEW JERSEY?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: AND THEN WHAT IS HAPPENING HERE? WHERE ARE THE DEVICES AND WHERE IS THE WORK BEING DONE?
CONSTANCE CULLEN: ON THIS PARTICULAR DOCUMENT?
MR. SCHENK: YES, MA'AM.
CONSTANCE CULLEN: SO THIS -- THE WORK THAT WAS DONE IN SUPPORT OF THIS PROTOCOL WAS COMPLETED AT THERANOS.
MR. SCHENK: OKAY. THESE -- ARE THEY CALLED ASSAYS THE CRH, IL-6?
CONSTANCE CULLEN: YES, SOMETIMES WE REFER TO THEM AS ASSAYS.
MR. SCHENK: SO WHERE WOULD THESE ASSAYS THEN PHYSICALLY BE WHILE THE WORK IS BEING DONE?
CONSTANCE CULLEN: THEY WOULD HAVE BEEN IN THERANOS.
MR. SCHENK: OKAY. AND I THINK YOU DESCRIBED MULTIPLEX AS A REFERENCE TO A CARTRIDGE.
CONSTANCE CULLEN: CORRECT. THAT WAS OUR LIMITED UNDERSTANDING OF THE TECHNOLOGY WAS THAT ALL THREE OF THESE ASSAYS COULD BE INCORPORATED ONTO A SINGLE CARTRIDGE.
MR. SCHENK: AND WHERE WOULD THAT CARTRIDGE BE?
CONSTANCE CULLEN: WITHIN THE INSTRUMENT AT THERANOS.
MR. SCHENK: OKAY.
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THEN HELP ME UNDERSTAND WHAT ROLE SCHERING-PLOUGH WAS PLAYING IN THAT, NOT THE BETA TESTING, BUT IN THIS VALIDATION?
CONSTANCE CULLEN: NO ROLE OTHER THAN REVIEW OF DOCUMENTS.
MR. SCHENK: OKAY. IF YOU COULD NOW TURN TO THE NEXT PAGE, IT'S PAGE 3. THERE'S A PARAGRAPH UNDER ESTIMATED SCHEDULE. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND IT SAYS THAT THE "STANDARD THERANOS INSTRUMENT RUN-TIME WILL BE ACCELERATED. THE TOTAL NUMBER OF CARTRIDGES PROVIDED WILL BE ABOUT 2700," AND THEN IT REPEATS THESE ASSAYS; IS THAT RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: "UP TO TEN ADDITIONAL INSTRUMENTS WILL BE SHIPPED. THE TOTAL EXPECTED RUNTIME IS AROUND ONE MONTH. THE TOTAL HUMAN CAPITAL COMMITMENT WILL ONLY BE FIVE DAYS OVER THE ENTIRE PROGRAM DURATION AS IT ONLY TAKES UP TO TEN MINUTES TO PREPARE AND LOAD A SAMPLE ON A SINGLE INSTRUMENT, AFTER WHICH THE INSTRUMENTS RUN ON THEIR OWN." SO THERE'S A REFERENCE HERE TO THE TOTAL EXPECTED RUN TIME BEING ONE MONTH. WHAT DOES THAT MEAN?
CONSTANCE CULLEN: I BELIEVE THAT THAT WOULD BE IN REFERENCE TO THE AMOUNT OF TOTAL TIME THAT IT WOULD TAKE TO EXECUTE THE PROTOCOL.
MR. SCHENK: SO THIS VALIDATION WORK THAT THERANOS WAS DOING IN CALIFORNIA WOULD TAKE ONE MONTH?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: AND THERE'S ALSO A REFERENCE TO CARTRIDGES AND INSTRUMENTS IN THOSE FIRST COUPLE OF SENTENCES. WHAT IS THAT A REFERENCE TO?
CONSTANCE CULLEN: SO THE CARTRIDGES WERE DISPOSABLES THAT WERE REQUIRED IN ORDER TO RUN THE INSTRUMENT AND GET THE RESULTS. AND THEN, I'M SORRY, COULD YOU REPEAT THE SECOND HALF OF YOUR QUESTION?
MR. SCHENK: YES. THERE'S A REFERENCE TO UP TO TEN ADDITIONAL INSTRUMENTS WILL BE SHIPPED.
CONSTANCE CULLEN: RIGHT. SO THE INSTRUMENT IS IN REFERENCE TO THE ACTUAL THERANOS MACHINE INTO WHICH THE CARTRIDGES ARE PLACED.
MR. SCHENK: OKAY. AND FOR THIS VALIDATION, AGAIN, WHERE WERE THE INSTRUMENTS?
CONSTANCE CULLEN: THE INSTRUMENTS WERE IN THERANOS.
MR. SCHENK: OKAY. THE ASSAYS THAT WE'VE TALKED ABOUT ON THE CARTRIDGE INTO THE DEVICE, THAT ALL HAPPENED AT THERANOS?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: THAT DID NOT HAPPEN AT SCHERING-PLOUGH?
CONSTANCE CULLEN: THAT IS CORRECT.
MR. SCHENK: THERE WERE, I THINK YOU TESTIFIED, TWO SEPARATE INSTRUMENTS THAT WERE SHIPPED TO SCHERING-PLOUGH FOR DIFFERENT WORK.
CONSTANCE CULLEN: THAT IS CORRECT.
MR. SCHENK: OKAY. WE'LL GET TO THAT IN A MOMENT. IF YOU WOULD NOW TURN TO TAB 200 IN YOUR BINDER. YOUR HONOR, THE GOVERNMENT OFFERS EXHIBIT 200 PURSUANT TO STIPULATION?
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 200 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: DR. CULLEN, THIS IS A DOCUMENT LABELLED SERVICES AGREEMENT. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. SCHENK: AND IS THIS AN AGREEMENT BETWEEN SCHERING AND THERANOS REGARDING THE VALIDATION THAT WE'VE TALKED ABOUT?
CONSTANCE CULLEN: IT IS AN AGREEMENT BETWEEN SCHERING AND THERANOS. WHAT I'M NOT CLEAR ABOUT IS WHETHER THIS WAS DOCUMENTING THE VALIDATION.
MR. SCHENK: OKAY. IN NUMBER 1, PROJECT, IT SAYS -- IS SPRI, IS THAT SCHERING-PLOUGH?
CONSTANCE CULLEN: YES, IT STANDS FOR SCHERING-PLOUGH RESEARCH INSTITUTE, WHICH WAS THE DIVISION WITHIN SCHERING-PLOUGH.
MR. SCHENK: OKAY. THE SERVICES INCLUDING, BUT NOT LIMITED TO, COMPREHENSIVE VALIDATION OF THE THERANOS -- IS THAT WORD CYTOKINE?
CONSTANCE CULLEN: YES, CYTOKINE.
MR. SCHENK: WHAT IS THE THERANOS CYTOKINE PANEL?
CONSTANCE CULLEN: SO IT WOULD HAVE BEEN THE THREE ANALYTES THAT WERE PREVIOUSLY DISCUSSED. SO TUMOR NECROSIS FACTOR, INTERLEUKIN-6, AND C REACTIVE PROTEIN.
MR. SCHENK: OKAY. SO DOES THAT CLARIFY FOR US WHICH TYPE OF WORK THIS AGREEMENT APPLIED TO?
CONSTANCE CULLEN: YES.
MR. SCHENK: OKAY. AT THE BOTTOM, NUMBER 4, THERE'S A PAYMENT TERMS SECTION. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THE PAYMENT IS $279,000?
CONSTANCE CULLEN: YES.
MR. SCHENK: IS THAT MONEY THAT SCHERING-PLOUGH WAS PAYING TO THERANOS, OR THE OTHER WAY AROUND?
CONSTANCE CULLEN: YES, SCHERING-PLOUGH WOULD HAVE PAID THAT TO THERANOS.
MR. SCHENK: WHY? WHAT WORK WAS THERANOS DOING THAT WAS BENEFICIAL OR WORTH PAYING FOR?
CONSTANCE CULLEN: IT WOULD HAVE BEEN TO COVER THE COST OF THE VALIDATION FOR THOSE THREE, THREE ANALYTES.
MR. SCHENK: THE THREE ANALYTES THAT WERE RUN AT THERANOS ON THERANOS MACHINES?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: GOT IT. OKAY. IF YOU'LL TURN NOW TO PAGE 13 ON THIS DOCUMENT. WE SEE AN INVOICE HERE FROM THERANOS BILLING SCHERING-PLOUGH. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THE AMOUNT IS $279,000?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: AND LISTED NEXT TO IT WE SEE A REFERENCE TO THOSE CARTRIDGES, THE ROUGHLY 2700 MULTIPLEX CARTRIDGES; IS THAT CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: SO THAT IS WHAT -- IS THAT WHAT SCHERING-PLOUGH WAS PAYING FOR?
CONSTANCE CULLEN: YES.
MR. SCHENK: IF WE CAN NOW TURN TO TAB 201. YOUR HONOR, THE GOVERNMENT OFFERS 201 PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 201 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: AND IF WE CAN START ON THE SECOND PAGE OF THIS EXHIBIT. DR. CULLEN, THERE'S AN EMAIL FROM MS. HOLMES TO JIM MCLEOD AND YOU ON APRIL 15TH, 2009. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. SCHENK: SHE WRITES, "DEAR JIM. "IN FOLLOW UP TO OUR DISCUSSIONS WITH CONNIE" -- THAT'S YOU?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: -- "WE HAVE CEMENTED A COMPREHENSIVE VALIDATION PROGRAM ON ONE OF OUR MULTIPLEXED CYTOKINE PANELS. I HAVE ATTACHED THE INVOICE AND PROGRAM OVERVIEW TO THIS EMAIL." DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THEN IN THE NEXT PARAGRAPH SHE THEN WRITE, "WE DID OF COURSE WORK THROUGH THE VALIDATION PROGRAM WITH CONNIE IN GREAT DETAIL. WE WILL PRESENT THE RESULTS OF THE VALIDATION BY YOUR VISIT IN MAY. WE CAN THEN USE THAT VISIT TO DISCUSS THE DATA AND THE BEST WAYS TO CREATE VALUE IN ONGOING PROGRAMS GIVEN THE ABILITY TO COLLECT HIGHER INTEGRITY DATA, FASTER." THERE'S A REFERENCE HERE TO A VISIT IN MAY.
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHAT IS THAT IN REGARDS TO?
CONSTANCE CULLEN: SO THAT WAS THE DUE DILIGENCE VISIT.
MR. SCHENK: AND WHAT DO YOU MEAN BY THAT? WHAT DUE DILIGENCE?
CONSTANCE CULLEN: SO DUE DILIGENCE IS A GROUP OF INDIVIDUALS WITH VARYING SUBJECT MATTER EXPERTISE GO TO VISIT IN PERSON A SITE FOR WHICH WE ARE EVALUATING TECHNOLOGY OR CONSIDERING USING THE TECHNOLOGY.
MR. SCHENK: AND WERE YOU PART OF THE INDIVIDUALS THAT WENT TO THERANOS?
CONSTANCE CULLEN: I WAS.
MR. SCHENK: OKAY. IF WE COULD NOW TURN TO 192, EXHIBIT 192. YOUR HONOR, THE GOVERNMENT OFFERS EXHIBIT 192 PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 192 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: DR. CULLEN, THIS APPEARS TO BE A CALENDAR INVITE. IT WAS SENT AT THE END OF MARCH 2009, BUT FOR A MEETING MAY 5TH, 2009. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THERE'S A LIST OF PARTICIPANTS FROM SCHERING-PLOUGH. IS YOUR NAME ONE OF THEM?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND A LITTLE BIT FURTHER DOWN, IT LOOKS LIKE THERE'S A LIST OF REQUESTED AGENDA ITEMS FROM SCHERING-PLOUGH. IS THAT RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: DO YOU MIND JUST BRIEFLY SUMMARIZING FOR THE JURY WHAT THESE ARE? WHAT WAS SCHERING-PLOUGH INTERESTED IN DISCUSSING AT THIS MAY 2009 MEETING AT THERANOS?
CONSTANCE CULLEN: RIGHT. SO WE WERE INTERESTED IN UNDERSTANDING HOW THERANOS WOULD APPROACH THE VALIDATION OF THE ASSAYS, TIMING. WE WERE ALSO INTERESTED IN THE DEVELOPMENT OF PROPRIETARY ASSAYS THAT WOULD BE EXCLUSIVE TO SCHERING-PLOUGH AS OPPOSED TO THE ALREADY AVAILABLE CYTOKINE PANELS THAT THERANOS HAD. AND THEN UNDERSTANDING MORE OF THE TECHNICAL DETAILS WITH RESPECT TO THE MULTIPLEXING, WHICH IS BEING ABLE TO MEASURE MULTIPLE ANALYTES SIMULTANEOUSLY. WE WERE INTERESTED IN COMPUTER SYSTEM VALIDATION BECAUSE THAT IS A REQUIREMENT FOR PROVIDING THESE DATA FOR CONSIDERATION BY THE FOOD AND DRUG ADMINISTRATION, UNDERSTANDING PATIENT CONFIDENTIALITY, AND THE LAST ITEM ON THE LIST IS WHAT IS CALLED INCURRED SAMPLE REANALYSIS. THIS IS ALSO A REQUIREMENT OF THE FOOD AND DRUG ADMINISTRATION TO SHOW THE REPRODUCIBILITY OF THE ASSAYS THAT ARE VALIDATED.
MR. SCHENK: THANK YOU. IF YOU WOULD TURN TO THE NEXT PAGE, PAGE 2 OF THIS EXHIBIT. IS THIS AN AGENDA FROM THE MAY MEETING?
CONSTANCE CULLEN: YES, IT IS.
MR. SCHENK: AND, AGAIN, YOU ATTENDED THIS MEETING IN PERSON?
CONSTANCE CULLEN: I DID.
MR. SCHENK: AND DID MS. HOLMES ATTEND IN PERSON?
CONSTANCE CULLEN: YES, SHE DID.
MR. SCHENK: WAS THAT THE FIRST TIME THAT YOU MET MS. HOLMES IN PERSON?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHAT DO YOU RECALL FROM THIS MEETING? DID YOU ASK QUESTIONS DURING THE MEETING?
CONSTANCE CULLEN: YES, I ASKED A LOT OF QUESTIONS. MY RECOLLECTION IS THAT THE ANSWERS TO THE QUESTIONS WERE NOT NECESSARILY FORTHCOMING. SO I WAS DISSATISFIED, QUITE HONESTLY, WITH THE RESPONSE TO THE QUESTIONS IN THAT THERE WAS INSUFFICIENT TECHNICAL DETAIL FOR US TO BE ABLE TO EVALUATE THE TECHNOLOGY.
MR. SCHENK: WHAT DO YOU MEAN WHEN YOU SAY "INSUFFICIENT DETAIL"?
CONSTANCE CULLEN: SO WHEN A SPONSOR, SUCH AS SCHERING-PLOUGH, USES A TECHNOLOGY IN SUPPORT OF THEIR DRUG DEVELOPMENT EFFORTS, WHICH EVENTUALLY GETS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION, WE ARE EXPECTED TO BE ABLE TO UNDERSTAND AND BE SUPPORTIVE FROM A SCIENTIFIC PERSPECTIVE OF THE TECHNOLOGY THAT WE USE TO MEASURE THOSE ANALYTES.
MR. SCHENK: WHEN YOU ASKED QUESTIONS DURING THE MEETING, DO YOU RECALL WHETHER MS. HOLMES WAS THE ONE THAT ANSWERED OR OTHER EMPLOYEES FROM THERANOS?
CONSTANCE CULLEN: ALMOST EXCLUSIVELY MS. HOLMES WAS THE ONE WHO ANSWERED THE QUESTIONS, IRRESPECTIVE OF TO WHOM THE QUESTION WAS ADDRESSED.
MR. SCHENK: WHAT DO YOU MEAN BY THAT?
CONSTANCE CULLEN: I MEAN THAT ON A COUPLE OF OCCASIONS I ATTEMPTED TO ASK QUESTIONS OF OTHER THERANOS STAFF WHO WERE IN THE MEETING AND IT -- THE RESPONSE WAS INTERRUPTED BY MS. HOLMES.
MR. SCHENK: WHY DID YOU TRY TO DIRECT SOME QUESTIONS TO OTHER THERANOS EMPLOYEES?
CONSTANCE CULLEN: BECAUSE THEY WERE BROUGHT INTO THE MEETING AS SUBJECT MATTER EXPERTS, AND ALSO, QUITE HONESTLY, I WANTED TO TRY TO GET ADDITIONAL INFORMATION WHICH, AS I MENTIONED, DID NOT SEEM TO BE FORTHCOMING.
MR. SCHENK: WHAT DO YOU MEAN WHEN YOU SAY INFORMATION WAS NOT FORTHCOMING?
CONSTANCE CULLEN: I MEAN THAT THERE WERE NO DIRECT ANSWERS TO QUESTIONS, AND THE QUESTIONS ARE FAIRLY TECHNICAL, SO THE ANSWERS SHOULD BE FAIRLY TECHNICAL AND DIRECT. AND SO, YOU KNOW, THERE WERE WHAT I DESCRIBE AS CAGEY RESPONSES OR ATTEMPTS TO REDIRECT TO OTHER TOPICS OF DISCUSSION.
MR. SCHENK: NOW, I APPRECIATE THE MEETING WAS IN 2009. DO YOU HAVE A SENSE OF THE TOPICS, THE KINDS OF QUESTIONS THAT WERE DISCUSSED? WE'VE TALKED ABOUT THE AGENDA ITEMS.
CONSTANCE CULLEN: RIGHT.
MR. SCHENK: BUT WHAT MADE IT INTO THE ACTUAL MEETING?
CONSTANCE CULLEN: CERTAINLY WE DISCUSSED THE VALIDATION AND HOW THE SOFTWARE REDUCES THE DATA, BECAUSE THAT WAS OF CRITICAL CONCERN TO US, AND WE CERTAINLY DISCUSSED, OR TRIED TO DISCUSS OR GET DETAILED INFORMATION ON HOW THE INSTRUMENT ACTUALLY WORKED FROM A TECHNICAL PERSPECTIVE.
MR. SCHENK: OKAY. DO YOU REMEMBER WHETHER AT THE END OF THE MEETING YOU EXPRESSED YOUR CONCERNS THAT YOU'VE JUST DESCRIBED TO US? YOU USED THE WORD "CAGEY." DID YOU SAY AT THE END OF THE MEETING, I FEEL THIS WAY ABOUT THIS MEETING? DO YOU HAVE THAT RECOLLECTION?
CONSTANCE CULLEN: I DID NOT SAY IT AT THE MEETING. I SHARED MY THOUGHTS PRIVATELY WITH SOME OF MY COLLEAGUES.
MR. SCHENK: WHY DIDN'T YOU SAY IT AT THE MEETING?
CONSTANCE CULLEN: UM, IT'S AWKWARD.
MR. SCHENK: OKAY. IF YOU'LL NOW TURN TO EXHIBIT 223 IN YOUR BINDER. YOUR HONOR, THE GOVERNMENT OFFERS EXHIBIT 223 PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 223 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: DR. CULLEN, WE'VE NOW MOVED INTO JUNE OF 2009, AND IF WE START AT THE BOTTOM, THERE'S AN EMAIL FROM YOU TO SOMEONE NAMED GARY FRENZEL. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. SCHENK: DID MR. FRENZEL WORKS AT THERANOS?
CONSTANCE CULLEN: YES, HE DID.
MR. SCHENK: AND YOU WRITE -- AND THE MEETING THAT YOU JUST TALKED ABOUT, THAT WAS IN MAY?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: SO WE'RE INTO THE NEXT MONTH; IS THAT RIGHT?
CONSTANCE CULLEN: THAT IS CORRECT.
MR. SCHENK: AND YOU'RE ASKING MR. FRENZEL TO CHECK IN AND GET AN ASSAY DEVELOPMENT UPDATE FOR THE TEAM?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHAT IS "THE TEAM" A REFERENCE TO?
CONSTANCE CULLEN: SO THE TEAM WOULD HAVE BEEN MYSELF, JIM MCLEOD, WHO AS I MENTIONED WAS THE HEAD OF OUR EARLY CLINICAL RESEARCH, AND OTHERS WHO WOULD HAVE PARTICIPATED ON THE DUE DILIGENCE MEETING.
MR. SCHENK: I SEE. AND WHEN YOU'RE ASKING FOR SOMETHING CALLED AN ASSAY DEVELOPMENT UPDATE, WHAT WERE YOU LOOKING FOR?
CONSTANCE CULLEN: SO I WAS LOOKING ON PROGRESS AGAINST THE PROTOCOL THAT YOU HAD MENTIONED OR SHOWN EARLIER.
MR. SCHENK: I SEE. AND A MOMENT AGO YOU SAID AT THE MEETING IN PALO ALTO, YOU FELT THAT THERANOS WAS LESS THAN FORTHCOMING; IS THAT FAIR?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHY, IF THAT WAS YOUR IMPRESSION, DID YOU WRITE A MONTH LATER ASKING FOR MORE INFORMATION ON ASSAY DEVELOPMENT?
CONSTANCE CULLEN: BECAUSE SCHERING-PLOUGH HAD PAID $279,000 FOR THIS WORK. WE HAD EXPECTED TO RECEIVE IT AT THAT MAY DUE DILIGENCE MEETING, AND WE DID NOT.
MR. SCHENK: ABOVE THIS EMAIL, MR. FRENZEL FORWARDS IT TO MS. HOLMES. DO YOU SEE THAT, FORWARDS YOUR EMAIL TO MS. HOLMES?
CONSTANCE CULLEN: YES.
MR. SCHENK: IF YOU'LL NOW TURN TO TAB 259. YOUR HONOR, THE GOVERNMENT OFFERS 259 PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 259 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: THE FIRST DOCUMENT IN 259 AT THE BOTTOM APPEARS TO BE AN EMAIL FROM MR. FRENZEL TO YOU. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND LET ME NOTE THAT THIS IS NOW IN DECEMBER. THE EMAIL THAT WE WERE JUST TALKING ABOUT WAS IN JUNE; IS THAT RIGHT?
CONSTANCE CULLEN: THAT'S RIGHT.
MR. SCHENK: SO ABOUT SIX MONTHS LATER, MR. FRENZEL WRITES, "HI CONNIE." THE SUBJECT WAS VALIDATION REPORT?
CONSTANCE CULLEN: UH-HUH.
MR. SCHENK: WAS THAT A YES?
CONSTANCE CULLEN: YES.
MR. SCHENK: "HI CONNIE, I WAS ASKED TO SEND THIS REPORT ON TO YOU, AND IF YOU CAN FORWARD TO THE PROPER PEOPLE. AFTER YOU AND YOUR GROUP HAVE AN OPPORTUNITY TO GO THROUGH IT, LET US KNOW IF YOU WOULD LIKE TO ARRANGE A PHONE CONFERENCE TO DISCUSS THE RESULTS." DO YOU SEE THAT?
CONSTANCE CULLEN: I DO.
MR. SCHENK: AND THEN ABOVE THIS EMAIL, MR. FRENZEL FORWARDS IT ALMOST TWO MONTHS LATER, THE END OF JANUARY 2010, TO SOMEONE NAMED DENNIS YAM. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: LET'S GO NOW TO THE ATTACHMENT. LET'S START ON PAGE 3. WHAT IS THIS DOCUMENT? WHAT ARE WE LOOKING AT?
CONSTANCE CULLEN: SO THIS WAS THE VALIDATION REPORT THAT THERANOS HAD PROVIDED.
MR. SCHENK: OKAY. THE REPORT THAT YOU MENTIONED EXPECTING TO SEE IN MAY AND WRITING ABOUT IN JUNE?
CONSTANCE CULLEN: CORRECT.
MR. SCHENK: OKAY. AND ON THIS PAGE, IF WE COULD ZOOM OUT, IN THE UPPER LEFT CORNER, DO YOU SEE THERANOS'S LOGO?
CONSTANCE CULLEN: I DO.
MR. SCHENK: IN THE UPPER RIGHT CORNER, DO YOU SEE A SCHERING-PLOUGH LOGO?
CONSTANCE CULLEN: I DO NOT.
MR. SCHENK: IF WE COULD NOW TURN TO PAGE 5. THERE IS DATA ON PAGE 5. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND IS THIS SCHERING-PLOUGH DATA?
MR. SCHENK: WHO GENERATED THIS DATA?
CONSTANCE CULLEN: THERANOS.
MR. SCHENK: ON PAGE 19, IF YOU'LL TURN TO PAGE 19, THERE'S A SECTION ENTITLED CONCLUSIONS. DO YOU SEE THAT?
CONSTANCE CULLEN: I DO.
MR. SCHENK: AND WHOSE CONCLUSIONS ARE THESE?
CONSTANCE CULLEN: THOSE WOULD HAVE BEEN THERANOS'S CONCLUSIONS SINCE THEY WROTE THE REPORT.
MR. SCHENK: DID -- LET ME FOCUS YOUR ATTENTION ON THE VERY FIRST SENTENCE OF THE CONCLUSIONS. IT READS, "THE THERANOS'S IL-6, TNF-A, AND CRP ASSAY MULTIPLEX HAS BEEN SHOWN TO GIVE ACCURATE AND PRECISE RESULTS FOR THREE INDEPENDENTLY CALIBRATED CARTRIDGE LOTS AND ALL THE MANY INSTRUMENTS USED." IS THAT A CONCLUSION THAT YOU REACHED?
MR. SCHENK: TO YOUR KNOWLEDGE, IS THAT A CONCLUSION THAT ANYBODY AT SCHERING-PLOUGH REACHED?
MR. SCHENK: WHEN YOU RECEIVED THIS DOCUMENT, YOU SAW THAT THE FIRST PAGE OF THIS EXHIBIT WAS MR. FRENZEL SENDING THIS TO YOU IN DECEMBER, DID YOU WRITE HIM BACK AND SAY, I AGREE WITH THESE CONCLUSIONS?
MR. SCHENK: WAS THERE EVER AN OCCASION WHEN YOU SAID THESE CONCLUSIONS ARE ACCURATE?
MR. SCHENK: TO YOUR KNOWLEDGE, WAS THERE EVER AN OCCASION WHEN ANYBODY AT SCHERING-PLOUGH SAID THIS DOCUMENT OR THESE CONCLUSIONS ARE ACCURATE?
MR. SCHENK: WOULD YOU NOW TURN TO PAGE 262? I'M SORRY, EXHIBIT 262. YOUR HONOR, THE GOVERNMENT OFFERS 262 TO PURSUANT TO STIPULATION.
MR. CLINE: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 262 WAS RECEIVED IN EVIDENCE.)
BY MR. SCHENK:
MR. SCHENK: YOU'LL SEE THIS IS A CONTINUATION OF A PRIOR EMAIL CHAIN. IF YOU START ON THE PAGE 2, THERE IS THAT EMAIL FROM MR. FRENZEL TO YOU IN DECEMBER WITH A VALIDATION REPORT. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND NOW IF WE COME BACK TO THE FIRST PAGE OF THIS EXHIBIT AT THE BOTTOM, A FEW DAYS LATER, ON THE 9TH OF DECEMBER, MR. FRENZEL FOLLOWS UP. "HI CONNIE, I JUST WANTED TO MAKE SURE THAT YOU RECEIVED THIS REPORT. WE ARE LOOKING FORWARD TO DISCUSSING IT WITH YOU." AND THEN YOU RESPOND ON THAT SAME DAY, "I'M SORRY FOR THE SLOW RESPONSE. I DID RECEIVE THE REPORT, I'D ACTUALLY LIKE TO DEFER OUR DISCUSSIONS UNTIL JANUARY. WE ARE TOTALLY SWAMPED WITH THE MERGER WITH MERCK." IS MERCK THE MERGER THAT YOU REFERENCED AT THE BEGINNING OF YOUR TESTIMONY?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: AND DO YOU RECALL HAVING THIS CONVERSATION? YOU REFERENCED DEFERRING A DISCUSSION UNTIL JANUARY. DO YOU RECALL IN JANUARY HAVING THAT CONVERSATION WITH MR. FRENZEL?
MR. SCHENK: DO YOU RECALL, AT ANY POINT AFTER DECEMBER OF 2009, HAVING FURTHER CONVERSATIONS WITH THERANOS WHERE YOU SAID ANYTHING POSITIVE ABOUT THAT VALIDATION REPORT?
MR. SCHENK: WOULD YOU NOW TURN TO EXHIBIT 291. YOUR HONOR, 291 HAS BEEN PREVIOUSLY ADMITTED. PERMISSION TO PUBLISH?
JUDGE DAVILA: YES.
MR. SCHENK: THANK YOU.
MR. SCHENK: DR. CULLEN, I'M SHOWING YOU THIS EMAIL. YOU'RE NOT ON IT. AT THE TOP, IT'S TO EMPLOYEES AT WALGREENS, PEOPLE AT WALGREENS.COM EMAIL ADDRESSES. DO YOU SEE THAT?
CONSTANCE CULLEN: I DO.
MR. SCHENK: THIS EMAIL WAS SENT IN APRIL OF 2010. AND DO YOU SEE THE THIRD ATTACHMENT?
CONSTANCE CULLEN: THIRD ATTACHMENT? NO. I'M SORRY.
MR. SCHENK: UNDER THE SUBJECT?
CONSTANCE CULLEN: OH. OH, YES, I DO.
MR. SCHENK: THE THIRD ATTACHMENT READS THERANOS MULTIPLEXED PANEL VALIDATION REPORT UNDERSCORE SCHERING-PLOUGH. DO YOU SEE THAT?
CONSTANCE CULLEN: I DO.
MR. SCHENK: AND THEN MS. HOLMES WRITES DEAR -- I'M SORRY. SHE WRITES, "DR. JAY, ALEX. "AS PER OUR DISCUSSION, PLEASE FIND THREE INDEPENDENT DUE DILIGENCE REPORTS ON THERANOS SYSTEMS ATTACHED TO THIS EMAIL. THESE REPORTS ARE FROM GLAXOSMITHKLINE, PFIZER, AND SCHERING-PLOUGH AFTER THEIR OWN TECHNICAL VALIDATION AND EXPERIENCE WITH THERANOS SYSTEMS IN THE FIELD." DID I READ THAT RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: THE VALIDATION REPORT THAT YOU AND I HAVE SPOKEN ABOUT, WOULD YOU CALL THAT SCHERING-PLOUGH'S OWN TECHNICAL VALIDATION?
MR. SCHENK: WE ALSO HAVE TALKED ABOUT SOME BETA TESTING. WOULD YOU DESCRIBE FOR THE JURY WHAT THAT WAS?
CONSTANCE CULLEN: YES. BETA TESTING WAS WE HAD TWO INSTRUMENTS IN THE LABORATORY AND WE HAD A VOLUNTEER FROM THE LAB PROVIDE A BLOOD SAMPLE AND WE MEASURED C REACTIVE PROTEIN. TO MY RECOLLECTION IT WAS A SINGLE DETERMINATION.
MR. SCHENK: WHAT DOES THAT MEAN, A SINGLE DETERMINATION?
CONSTANCE CULLEN: IT MEANS WE TESTED ONE SAMPLE ONCE.
MR. SCHENK: THE PHRASE IN THIS EMAIL THAT I HIGHLIGHTED FOR YOU, SCHERING-PLOUGH'S OWN TECHNICAL VALIDATION, YOU SAID THAT WOULD NOT BE ACCURATE FOR THE REPORT, THE VALIDATION REPORT?
CONSTANCE CULLEN: THAT IS CORRECT.
MR. SCHENK: WOULD THAT BE ACCURATE FOR THE BETA TESTING?
CONSTANCE CULLEN: NO, IT WOULD NOT.
MR. SCHENK: WHY?
CONSTANCE CULLEN: TOO FEW SAMPLES, NO PROTOCOL WITH PREDEFINED ACCEPTANCE CRITERIA.
MR. SCHENK: IF YOU'LL TURN TO IN EXHIBIT 291, PAGE 34 OF THE EXHIBIT. DO YOU SEE A COPY OF THE THERANOS MULTIPLEXED VALIDATION AND A REFERENCE AGAIN TO IL-6, TNF-ALPHA, AND CRP?
CONSTANCE CULLEN: I DO.
MR. SCHENK: AND AGAIN, IS THIS THE VALIDATION REPORT THAT YOU HAVE TESTIFIED ABOUT PREVIOUSLY FROM TODAY?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND IN THE UPPER LEFT-HAND CORNER, WHAT DO YOU SEE?
CONSTANCE CULLEN: I SEE THE SCHERING-PLOUGH LOGO.
MR. SCHENK: OKAY. IF I COULD, MS. HOLLIMAN, IF IT'S POSSIBLE IF WE COULD BRING UP 259, PAGE 3, AND EXHIBIT 291, PAGE 34 AT THE SAME TIME. THE DOCUMENT ON THE LEFT, DR. CULLEN, IS 259, PAGE 3. IS THAT THE VERSION THAT WAS EMAILED TO YOU BY MR. FRENZEL?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND WHAT I'M SHOWING ON THE RIGHT, IS THAT A VERSION THAT WAS SENT AT LEAST IN THE EMAIL TO WALGREENS?
CONSTANCE CULLEN: I DON'T KNOW WHAT DOCUMENT WOULD HAVE BEEN SENT TO WALGREENS.
MR. SCHENK: IN EXHIBIT 291 THAT I'VE SHOWED YOU, THOUGH, IS THAT --
CONSTANCE CULLEN: YES, YES.
MR. SCHENK: -- IT IS THAT SAME DOCUMENT; IS THAT RIGHT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND MS. HOLLIMAN, IF WE COULD ALSO BRING UP 259, PAGE 19, AND 291, PAGE 51. DR. CULLEN, A MOMENT AGO I READ FOR YOU THE CONCLUSION SECTION IN THE VALIDATION REPORT THAT WAS SENT TO SCHERING-PLOUGH. DO YOU RECALL THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND THAT'S APPEARING NOW AT THE TOP OF THE SCREEN, THAT THE THERANOS MULTIPLEXED ASSAYS WERE SHOWN TO GIVE ACCURATE AND PRECISE RESULTS FOR THREE INDEPENDENTLY CALIBRATED CARTRIDGE LOTS. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. SCHENK: AND I THINK YOU TOLD US THAT WAS NOT A SCHERING-PLOUGH CONCLUSION; IS THAT RIGHT?
CONSTANCE CULLEN: THAT IS CORRECT.
MR. SCHENK: AND IN EXHIBIT 291, THE VERSION THAT WAS ATTACHED TO THE WALGREENS EMAIL, THE FIRST SENTENCE OF THE CONCLUSIONS NOW READS, "THE THERANOS IL-6, TNF-ALPHA, CRP ASSAYS MULTIPLEX HAS BEEN SHOWN TO GIVE MORE ACCURATE AND PRECISE RESULTS FOR THREE INDEPENDENTLY CALIBRATED CARTRIDGE LOTS AND ALL OF THE MANY INSTRUMENTS USED THAN CURRENT 'GOLD STANDARD' REFERENCE METHODS." DID I READ THAT RIGHT?
CONSTANCE CULLEN: YES.
MR. SCHENK: IT MAY GO WITHOUT SAYING, BUT YOU DID NOT APPROVE THE VERSION ON TOP, THE ONE THAT WAS SENT TO YOU; IS THAT CORRECT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. SCHENK: AND THE ENHANCED CONCLUSION, IS THAT SOMETHING THAT YOU WOULD AGREE WITH?
MR. SCHENK: IS THAT SOMETHING THAT, TO YOUR KNOWLEDGE, ANYBODY FROM SCHERING-PLOUGH AGREED WITH?
MR. SCHENK: YOUR HONOR, MAY I HAVE ONE MOMENT?
JUDGE DAVILA: YES.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
MR. SCHENK: THANK YOU. NO FURTHER QUESTIONS.
JUDGE DAVILA: MR. CLINE, DO YOU HAVE CROSS-EXAMINATION?
MR. CLINE: I DO.
CROSS-EXAMINATION BY MR. CLINE:
MR. CLINE: DR. CULLEN, GOOD AFTERNOON.
CONSTANCE CULLEN: GOOD AFTERNOON.
MR. CLINE: MY NAME IS JOHN CLINE AND I'M ONE OF THE LAWYERS FOR MS. HOLMES. LET ME START BY TAKING CARE A LITTLE BIT OF ADMINISTRATIVE STUFF HERE. YOUR HONOR, MAY I APPROACH THE WITNESS?
JUDGE DAVILA: YES.
BY MR. CLINE:
MR. CLINE: DR. CULLEN, I'M GOING TO HAND YOU ANOTHER BINDER --
CONSTANCE CULLEN: OKAY.
MR. CLINE: -- WHICH HAS SOME OTHER EXHIBITS IN IT THAT I WILL BE REFERRING YOU TO AS WE GO ALONG (HANDING.) DR. CULLEN, LET ME START WITH THAT BETA TESTING THAT MR. SCHENK MENTIONED TO YOU. THAT'S WHERE YOU GOT THE ACTUAL PHYSICAL MACHINES FROM THERANOS?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND HOW MANY DID YOU GET? YOU GOT TWO?
CONSTANCE CULLEN: MY RECOLLECTION IS THAT WE GOT TWO.
MR. CLINE: ALL RIGHT. AND YOU RAN ONE ASSAY, ONE SAMPLE?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: WAS IT ON ONE MACHINE? TWO MACHINES?
CONSTANCE CULLEN: I DON'T RECALL IF IT WAS ON ONE OR TWO MACHINES.
MR. CLINE: ALL RIGHT. AND THE -- YOU AND YOUR TEAM THOUGHT THAT THE DEVICE WORKED WELL; CORRECT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND YOU THOUGHT IT APPEARED TO PROVIDE ACCURATE RESULTS; RIGHT?
CONSTANCE CULLEN: AS FAR AS WE COULD TELL.
MR. CLINE: THAT WAS YOUR THOUGHT AT THE TIME, THOUGH, THAT IT APPEARED TO PROVIDE ACCURATE RESULTS?
CONSTANCE CULLEN: AS FAR AS WE COULD TELL.
MR. CLINE: YES. AND YOU WERE -- YOU AND YOUR TEAM WERE IMPRESSED WITH ITS SENSITIVITY; CORRECT?
CONSTANCE CULLEN: WE WERE IMPRESSED WITH THE SENSITIVITY.
MR. CLINE: ALL RIGHT. SO LET ME NOW TURN TO THE SECOND PART OF WHAT YOU TESTIFIED ABOUT, WHICH IS THE, THE VALIDATION PART. OKAY?
CONSTANCE CULLEN: OKAY.
MR. CLINE: IF YOU COULD GO TO EXHIBIT 10570 IN THE BINDER THAT I'VE JUST HANDED YOU. DO YOU SEE THAT? DID YOU FIND THAT, DR. CULLEN?
CONSTANCE CULLEN: I DID.
MR. CLINE: ALL RIGHT. AND THAT IS AN EMAIL FROM YOU -- I'M SORRY, FROM MS. HOLMES TO YOU, WITH VARIOUS PEOPLE COPIED; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: YOUR HONOR, I THINK WE'VE AGREED THAT THIS IS ADMISSIBLE, SO I'LL OFFER 10570.
MR. SCHENK: THAT'S CORRECT.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10570 WAS RECEIVED IN EVIDENCE.)
MR. CLINE: ALL RIGHT. IF WE CAN PUT THAT UP, PLEASE. THAT'S FINE.
MR. CLINE: NOW, THE SUBJECT LINE ON THIS IS FOLLOW UP TO OUR CALL. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND THE DATE OF THIS IS NOVEMBER THE 12TH, 2008.
CONSTANCE CULLEN: CORRECT.
MR. CLINE: DOES THIS HELP YOU RECALL THAT YOUR INITIAL COMMUNICATION WITH MS. HOLMES WAS IN LATE 2008?
CONSTANCE CULLEN: I MEAN, I CAN'T DISAGREE WITH THE EMAIL, BUT I DON'T RECALL THAT.
MR. CLINE: ALL RIGHT. I RECOGNIZE THAT THIS WAS A LONG TIME AGO.
CONSTANCE CULLEN: RIGHT.
MR. CLINE: I'M JUST ASKING YOU TO GIVE YOUR BEST --
CONSTANCE CULLEN: SURE.
MR. CLINE: -- ESTIMATE. LET'S PUT IT THAT WAY. AND THE SUBJECT IS FOLLOW UP TO OUR CALL. MS. HOLMES SAYS, "CONNIE. "GREAT TO CONNECT." SUGGESTING THAT THE TWO OF YOU HAVE HAD SOME SORT OF A PHONE CALL; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND THEN SHE SAYS, "WE HAVE ATTACHED SEVERAL REPORTS FROM PROGRAMS WE HAVE DONE WITH OTHER PHARMACEUTICAL COMPANIES." DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND THEN I'M NOT GOING TO ASK YOU TO GO THROUGH ALL OF THE ATTACHMENTS, BUT THERE'S AN ATTACHMENT FROM, FOR EXAMPLE, SOMETHING FROM NOVARTIS, THERE'S AN ATTACHMENT WITH SOMETHING FROM GSK. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND YOU RECOGNIZE NOVARTIS AND GSK AS MAJOR PHARMACEUTICAL COMPANIES; CORRECT?
CONSTANCE CULLEN: I DO.
MR. CLINE: AND DO YOU RECALL, SITTING HERE TODAY, IF YOU LOOKED THROUGH THESE REPORTS WHEN MS. HOLMES SENT THEM TO YOU?
CONSTANCE CULLEN: I BELIEVE THAT I DID.
MR. CLINE: OKAY. NOW, LET'S GO TO 10571. AGAIN, YOUR HONOR, THIS IS ONE THAT WE AGREE CAN BE ADMITTED.
MR. SCHENK: CORRECT.
MR. CLINE: SO I'LL OFFER 10571.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10571 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: NOW, DR. CULLEN, IF YOU LOOK DOWN AT THE VERY BOTTOM OF THIS EXHIBIT, YOU'LL SEE THAT THAT'S THE NOVEMBER 12TH, 2008 EMAIL THAT WE WERE TALKING ABOUT. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND THEN MOVING UP THE PAGE AND FORWARD IN TIME, THERE'S AN EMAIL FROM YOU TO MS. HOLMES. DO YOU SEE THAT?
CONSTANCE CULLEN: CORRECT, YES, I DO.
MR. CLINE: DECEMBER 10TH, 2008. AND IT'S COPIED A MS. CAROLYN BALKENHOL. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND MR. FRENZEL. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND DO YOU RECALL THAT THEY WERE BOTH THERANOS EMPLOYEES WHO WERE PART OF THE EFFORT TO INTERACT WITH SCHERING-PLOUGH?
CONSTANCE CULLEN: I REMEMBER GARY FRENZEL. I DO NOT REMEMBER CAROLYN BALKENHOL.
MR. CLINE: AND IN THAT EMAIL FROM YOU TO ELIZABETH HOLMES, YOU SAY, "ELIZABETH. "I WAS WONDERING IF YOU COULD PROVIDE YOUR VALIDATION REPORTS ON ANY OF THESE ASSAYS?" AND THAT REFERS TO THE REPORTS THAT WE WERE JUST TALKING ABOUT; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND GSK AND NOVARTIS?
CONSTANCE CULLEN: (NODS HEAD UP AND DOWN.)
MR. CLINE: I'M SORRY. I NEED AN AUDIBLE ANSWER.
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: AND YOU SAY, "THE REPORTS THAT YOU PROVIDED SHOWED CORRELATIONS BETWEEN YOUR ASSAYS AND CORRESPONDING COMMERCIAL ASSAYS WHICH IS IMPORTANT, BUT I WAS MORE INTERESTED IN THE VALIDATION REPORTS FOR YOUR ASSAYS." DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. CLINE: AND THEN THE TOP EMAIL DATED DECEMBER 13TH, 2008 IS FROM MS. BALKENHOL TO YOU, COPYING MR. FRENZEL AND MS. HOLMES. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. CLINE: AND MS. BALKENHOL ATTACHES A TOTAL OF FOUR VALIDATION SUMMARY REPORTS; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND YOU HAD ASKED FOR TWO OF THEM, AND I GUESS MS. BALKENHOL OR SOMEBODY AT THERANOS DECIDED TO PUT IN TWO MORE; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: YES. AND DID YOU, DR. CULLEN, REVIEW THESE SUMMARY REPORTS WHEN YOU HAD SEEN THEM?
CONSTANCE CULLEN: I PROBABLY REVIEWED THE INFLAMMATORY ONES. I CAN'T SAY FOR SURE WHETHER I REVIEWED THE OTHER TWO REPORTS.
MR. CLINE: SO THE INFLAMMATORY ONE IS WHICH ONE?
CONSTANCE CULLEN: SORRY. INTERLEUKIN-6 AND TUMOR NECROSIS FACTOR ALPHA.
MR. CLINE: SO THE IL-6 AND TNF-ALPHA?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: SO LET'S GO FORWARD NOW TO EXHIBIT 7079, OR ACTUALLY YOU'RE PROBABLY GOING BACKWARDS, 7079. FORWARD IN TIME, BACKWARDS IN THE BOOK. ARE YOU WITH ME?
CONSTANCE CULLEN: YES.
MR. CLINE: YOUR HONOR, I THINK 7079 WE'VE AGREED CAN BE ADMITTED, SO I'LL OFFER IT.
MR. SCHENK: YES.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7079 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: NOW, DR. CULLEN, THIS IS AN EMAIL FROM MS. HOLMES TO MR. MCLEOD AND YOU; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: WAS MR. MCLEOD, WAS HE YOUR BOSS AT THE TIME? A COLLEAGUE? WHERE DID YOU --
CONSTANCE CULLEN: NO. HE WAS MY BOSS'S COLLEAGUE, I GUESS.
MR. CLINE: ALL RIGHT.
CONSTANCE CULLEN: SO HE WAS LEADING THE EARLY CLINICAL MEDICINE GROUP.
MR. CLINE: OKAY. SO IN THE NO DOUBT COMPLICATED CORPORATE STRUCTURE OF SCHERING-PLOUGH, HE WAS ABOVE YOU, BUT SORT OF TO THE SIDE?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: SO, MS. HOLMES SAYS, "DEAR JIM. "IN FOLLOW UP TO OUR DISCUSSIONS WITH CONNIE" -- AND CONNIE IS YOU; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: -- "WE HAVE CEMENTED A COMPREHENSIVE VALIDATION PROGRAM ON ONE OF OUR MULTIPLEXED CYTOKINE" -- AM I PRONOUNCING THAT RIGHT?
CONSTANCE CULLEN: CYTOKINE.
MR. CLINE: -- "CYTOKINE PANELS. I HAVE ATTACHED THE INVOICE AND PROGRAM OVERVIEW TO THIS EMAIL." AND IN THE NEXT PARAGRAPH MS. HOLMES SAYS, "WE DID OF COURSE WORK THROUGH THE VALIDATION PROGRAM WITH CONNIE IN GREAT DETAIL." AND THAT WAS TRUE; RIGHT?
CONSTANCE CULLEN: I DON'T KNOW HOW TRUE IT WAS. THEY PROVIDED A VALIDATION PROTOCOL WHICH WAS SHOWN EARLIER. IT'S NOT -- I MEAN, IT HIT THE REQUIREMENTS. BUT AT THE END OF THE DAY, THE EXECUTION WOULD NOT HAVE BEEN IN ALIGNMENT WITH FDA OR HEALTH AUTHORITY REQUIREMENTS FOR VALIDATION.
MR. CLINE: WELL, LET ME ASK YOU THIS: YOU AND MS. HOLMES, OR YOU AND OTHERS AT THERANOS HAD DISCUSSED THIS VALIDATION PROTOCOL BEFORE IT WAS SENT TO MR. MCLEOD; RIGHT?
CONSTANCE CULLEN: I DON'T KNOW WHETHER OR NOT WE DISCUSSED IT PRIOR TO IT BEING SENT TO MCLEOD. WE WOULD HAVE DISCUSSED IT AS PEERS PRIOR TO THIS EMAIL IF THAT'S WHAT YOU'RE ASKING.
MR. CLINE: THAT'S WHAT I'M ASKING.
CONSTANCE CULLEN: OKAY.
MR. CLINE: YOU AND EITHER MS. HOLMES OR SOMEONE ELSE AT THERANOS HAD DISCUSSED THIS VALIDATION PROTOCOL BEFORE IT WAS SENT TO -- BEFORE THIS EMAIL; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: OKAY. SO LET'S -- AND I TAKE IT THAT AT LEAST IN ANY SORT OF EMAIL FORM OR IN ANY SORT OF COMMUNICATION WITH MS. HOLMES, YOU DID NOT, UPON RECEIVING THIS EMAIL, SAY, THAT'S AN INADEQUATE VALIDATION PROTOCOL; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT, WITH RESPECT TO THE PROTOCOL.
MR. CLINE: ALL RIGHT. SO LET'S MOVE FORWARD THROUGH THIS A LITTLE BIT. IF YOU CAN FLIP TO THE NEXT PAGE. ARE YOU WITH ME?
CONSTANCE CULLEN: YES.
MR. CLINE: AND THAT'S THE -- AT LEAST A SORT OF DRAFT OF THE INVOICE THAT WE LOOKED AT BEFORE; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND IF YOU GO OVER TO THE SECOND PAGE OF THE INVOICE, THE THIRD PAGE OF THE EXHIBIT -- CAN WE BLOW UP THE VERY TOP, PLEASE? THAT'S FINE. THE INVOICE SAYS, "KEY PROJECT OBJECTIVE." DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND CAN YOU JUST READ THAT TO US, PLEASE?
CONSTANCE CULLEN: YES. "COMPREHENSIVE VALIDATION OF THE THERANOS CYTOKINE PANEL UNDER FDA/ICH GUIDELINES, ACCORDING TO THE FULL VALIDATION PROTOCOL BELOW. PROJECT SUCCESS CRITERIA INCLUDE ANALYSIS OF BLINDED SAMPLES PROVIDED BY SCHERING-PLOUGH."
MR. CLINE: ALL RIGHT. AND ON THIS VERSION OF THE INVOICE, THE EXPECTED START DATE IS APRIL 15TH, 2009. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. CLINE: AND THE EXPECTED END DATE IS TO BE DETERMINED; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND SIMILARLY, THE TOTAL DURATION OF SERVICES IS TO BE DETERMINED; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND THEN IF WE GO TO THE NEXT PAGE, WE FIND THE THERANOS SYSTEM FULL VALIDATION PROTOCOL, WHICH I BELIEVE YOU TESTIFIED ABOUT BEFORE; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: SO NOW LET'S GO TO EXHIBIT 200. AND BY THE WAY, THIS VALIDATION PROTOCOL THAT YOU'VE TESTIFIED ABOUT, THAT WAS THE VALIDATION PROTOCOL THAT GOVERNED THE VALIDATION PORTION OF SCHERING-PLOUGH'S INTERACTIONS WITH THERANOS; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: ALL RIGHT. SO LET'S GO TO EXHIBIT 200, WHICH I THINK YOU'VE ALREADY TESTIFIED ABOUT, AND WHICH IS IN EVIDENCE. THIS IS THE SERVICES AGREEMENT BETWEEN SCHERING-PLOUGH AND THERANOS; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: SO THIS IS THE AGREEMENT THAT GOVERNS THE RELATIONSHIP BETWEEN THE TWO COMPANIES WITH RESPECT TO THE VALIDATION; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND AS I THINK MR. SCHENK POINTED OUT ON DIRECT, IF YOU LOOK ON PAGE 1, THE FIRST NUMBERED PARAGRAPH, IN DESCRIBING THE PROJECT, THIS AGREEMENT SAYS, "PROVIDER WILL PROVIDE TO SCHERING-PLOUGH SERVICES INCLUDING BUT NOT LIMITED TO COMPREHENSIVE VALIDATION OF THE THERANOS CYTOKINE PANEL UNDER FDA/ICH GUIDELINES-SCHERING-PLOUGH 001 AS FURTHER DESCRIBED IN ATTACHMENT C (INVOICE)." DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. CLINE: AND THIS AGREEMENT WAS SIGNED BY MR. MCLEOD; CORRECT?
CONSTANCE CULLEN: THAT'S MY UNDERSTANDING, YES.
MR. CLINE: ALL RIGHT. SO IF YOU -- IF WE MOVE FORWARD IN THIS, LET'S GO TO PAGE 9. MS. HOLMES SIGNS FOR THERANOS; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND MR. MCLEOD SIGNS FOR SCHERING-PLOUGH; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND IT LOOKS LIKE THEY BOTH SIGN APRIL 29TH, 2009; RIGHT?
CONSTANCE CULLEN: YES.
MR. CLINE: SO PRESUMABLY THAT APRIL 15TH, 2009 START DATE IS NOW INOPERATIVE?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND IF WE GO A FEW PAGES FURTHER, PAGE 13 OF EXHIBIT 200, WE NOW FIND AN INITIALLED VERSION OF THE INVOICE. DO YOU SEE THAT?
CONSTANCE CULLEN: YES, I DO.
MR. CLINE: AND THE INVOICE DATE IS APRIL 29TH, 2009; RIGHT?
CONSTANCE CULLEN: I SEE 30 APRIL 2009.
MR. CLINE: LOOK AT THE --
CONSTANCE CULLEN: OH, THE DATE. I'M SORRY. I THOUGHT YOU WERE REFERRING TO THE SIGNATURE.
MR. CLINE: OKAY. BUT YOU SEE THE DATE APRIL 29TH, 2009?
CONSTANCE CULLEN: I DO.
MR. CLINE: AND THE INITIAL IS A LITTLE BIT HARD TO MAKE OUT, BUT DOES IT LOOK TO YOU LIKE MR. MCLEOD'S INITIAL THERE?
CONSTANCE CULLEN: YES.
MR. CLINE: WHICH SUGGESTS TO YOU THAT HE HAD REVIEWED AND APPROVED THIS, I TAKE IT?
CONSTANCE CULLEN: I WOULD GUESS SO.
MR. SCHENK: OBJECTION. CALLS FOR SPECULATION.
JUDGE DAVILA: IF YOU KNOW? DO YOU KNOW?
CONSTANCE CULLEN: I DON'T KNOW.
BY MR. CLINE:
MR. CLINE: ALL RIGHT. I DON'T WANT YOU TO SPECULATE. AND IF YOU LOOK OVER ON THE NEXT PAGE OF THIS INVOICE, YOU SEE, "KEY PROJECT OBJECTIVE"?
CONSTANCE CULLEN: YES, I DO.
MR. CLINE: AND THAT'S THE SAME KEY PROJECT OBJECTIVE THAT YOU READ A MOMENT AGO; IS THAT RIGHT?
CONSTANCE CULLEN: YES.
MR. CLINE: AND WHICH IS "COMPREHENSIVE VALIDATION OF THE THERANOS CYTOKINE PANEL UNDER FDA/ICH GUIDELINES, ACCORDING TO ATTACHED FULL VALIDATION PROTOCOL." DO YOU SEE THAT?
CONSTANCE CULLEN: CORRECT, YES.
MR. CLINE: AND THE START DATE, THE EXPECTED START DATE IS NOW MAY 1ST, 2009. DO YOU SEE THAT?
CONSTANCE CULLEN: I DO.
MR. CLINE: AND THE END DATE IS STILL TBD?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND THE TOTAL DURATION IS TBD; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: NOW, MAY 1ST, 2009 WAS JUST FOUR DAYS BEFORE YOU ACTUALLY VISITED THERANOS; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: SO REALISTICALLY, THIS WAS NOT GOING TO BE DONE BEFORE YOU VISITED; RIGHT?
CONSTANCE CULLEN: ONE OF THE, ONE OF THE SELLING FEATURES OF THE TECHNOLOGY WAS SPEED. BUT IN MY ESTIMATION, NO, IT COULD NOT HAVE BEEN COMPLETED IN FOUR DAYS.
MR. CLINE: ALL RIGHT. I MEAN, IT TOOK 14 DAYS JUST TO GET THIS INVOICE UPDATED; RIGHT? SO IT'S UNLIKELY THAT THIS PROJECT IS GOING TO BE ACCOMPLISHED IN FOUR DAYS; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: NOW, IF YOU -- IF WE CONTINUE WITH EXHIBIT 200, YOU SEE THAT IT INCLUDES THE THERANOS SYSTEM FULL VALIDATION PROTOCOL; RIGHT? DO YOU SEE THAT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND AGAIN, THAT WAS THE PROTOCOL THAT WAS ATTACHED TO THAT APRIL 15TH, 2009 EMAIL; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: NOW, IT IS INCLUDED IN THE AGREEMENT BETWEEN THE PARTIES HERE; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: NOW, LET'S GO FORWARD TO EXHIBIT 10572. I THINK WE AGREED ON THIS, DIDN'T WE?
MR. SCHENK: YES.
MR. CLINE: I'LL OFFER 10572.
MR. SCHENK: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10572 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: NOW, YOU'VE TESTIFIED THAT YOU AND SEVERAL OF YOUR COLLEAGUES FROM SCHERING-PLOUGH VISITED THERANOS ON MAY 5TH, 2009; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND THIS IS THE AGENDA FOR THAT MEETING; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND THIS WAS, I TAKE IT, SHARED AMONG THE PARTICIPANTS SO YOU WOULD KNOW SORT OF THE ROADMAP OF WHERE YOU WERE GOING FOR THE DAY?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: DID MR. -- LOOKING DOWN AT THE BOTTOM NOW, DID MR. MCLEOD JOIN BY PHONE, DO YOU RECALL?
CONSTANCE CULLEN: I DON'T RECALL.
MR. CLINE: OKAY. NOW, ACCORDING TO THE AGENDA, YOU WERE STARTING AT 8:00 O'CLOCK AND YOU'RE ENDING AT 4:30 OR AFTER. DO YOU SEE THAT?
CONSTANCE CULLEN: YES.
MR. CLINE: IS IT YOUR RECOLLECTION THAT THIS MEETING LASTED PRETTY MUCH A FULL DAY?
CONSTANCE CULLEN: YES.
MR. CLINE: AND THE COLLEAGUES FROM SCHERING-PLOUGH WHO CAME WITH YOU, IF I SCAN THEIR QUALIFICATIONS QUICKLY, IT LOOKS LIKE THEY ALL EITHER HAD PH.D.'S OR WERE MEDICAL DOCTORS, OR BOTH; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: NOW, I THINK YOU TESTIFIED THAT YOU DIDN'T FEEL AS THOUGH YOU HAD RECEIVED THE INFORMATION THAT YOU NEEDED OR DIRECT ANSWERS TO THE TECHNICAL QUESTIONS THAT YOU ASKED; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: BUT I THINK YOU ALSO TESTIFIED THAT YOU DID NOT VOICE THOSE CONCERNS TO MS. HOLMES OR TO THERANOS OUT OF POLITENESS OR AWKWARDNESS OR SOME REASON LIKE THAT; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: YOU VOICED THEM TO YOUR COLLEAGUES, BUT NOT TO THERANOS?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND THERE'S A FOLLOW-ON EMAIL JUNE 16TH OF 2009, WHICH I THINK YOU TALKED ABOUT ON DIRECT, TO MR. FRENZEL WHERE YOU'RE ASKING HIM TO SORT OF GIVE ME A STATUS REPORT. APART FROM THAT, ARE YOU AWARE OF ANY EMAILS FROM SCHERING-PLOUGH ON ONE HAND TO THERANOS ON THE OTHER ASKING FOR MORE INFORMATION?
CONSTANCE CULLEN: I AM NOT.
MR. CLINE: NOW, IF WE COULD GO TO 10573. AND I BELIEVE THIS IS -- WE'VE AGREED TO ADMIT THIS?
MR. SCHENK: YES.
MR. CLINE: I'LL OFFER 10573.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10573 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: AND IT MAY BE THAT THIS IS IDENTICAL TO AN EXHIBIT THAT YOU HAVE ALREADY LOOKED AT?
CONSTANCE CULLEN: YES.
MR. CLINE: BUT IT'S NOW DECEMBER OF 2009, AND MR. FRENZEL IS EMAILING YOU THE VALIDATION REPORT; CORRECT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: AND HE SENDS IT TO YOU DECEMBER 3RD, 2009. THE SUBJECT LINE IS VALIDATION REPORT. AND THEN A FEW DAYS LATER, DECEMBER 9TH, 2009, HE WRITES TO YOU AGAIN AND SAYS, "I JUST WANTED TO MAKE SURE THAT YOU RECEIVED THIS REPORT. WE ARE LOOKING FORWARD TO DISCUSSING IT WITH YOU." RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: NOW, AT ABOUT THIS TIME, SCHERING-PLOUGH WAS IN THE PROCESS OF MERGING WITH OR BEING ACQUIRED BY MERCK; IS THAT RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: AND YOU WERE VERY BUSY WITH THAT PROCESS; CORRECT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND ULTIMATELY YOU ENDED UP WITH A POSITION AT MERCK; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: AND WAS IT A PROMOTION FROM THE POSITION THAT YOU HAD PREVIOUSLY HELD AT SCHERING-PLOUGH?
CONSTANCE CULLEN: IT WAS NOT A PROMOTION, BUT THEY DID MAKE ME RESPONSIBLE FOR THE COMBINED GROUP BETWEEN THE SCHERING-PLOUGH AND THE MERCK ORGANIZATIONS.
MR. CLINE: THAT SOUNDS LIKE A BIG COMPANY. NO PROMOTION, BUT MORE RESPONSIBILITY?
CONSTANCE CULLEN: I EVENTUALLY GOT THE PROMOTION.
MR. CLINE: OKAY. GLAD TO HEAR IT. SO IF WE GO NOW TO EXHIBIT 262, WHICH I THINK IS IN EVIDENCE. SORRY TO BE MOVING YOU BACK AND FORTH. AND 262, I THINK, IS IN THE GOVERNMENT'S BINDER, BUT WE'LL PUT IT UP ON THE SCREEN SO THAT YOU CAN SEE IT. YOU WRITE BACK QUICKLY TO MR. FRENZEL AFTER HE SENDS THAT DECEMBER 9TH EMAIL AND YOU SAY, "I'M SORRY FOR THE SLOW RESPONSE. I DID RECEIVE THE REPORT. I'D ACTUALLY LIKE TO DEFER OUR DISCUSSIONS UNTIL JANUARY. WE ARE TOTALLY SWAMPED WITH THE MERGER WITH MERCK." DO YOU SEE THAT?
CONSTANCE CULLEN: THAT'S CORRECT, YES.
MR. CLINE: AND, IN FACT, THAT'S WHAT WAS GOING ON; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: SO LET'S GO FORWARD NOW TO 10574. AND AGAIN, YOUR HONOR, I BELIEVE WE HAVE AGREED THAT THIS CAN BE ADMITTED.
MR. SCHENK: YES, NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10574 WAS RECEIVED IN EVIDENCE.)
BY MR. CLINE:
MR. CLINE: ALL RIGHT. SO LET ME -- LET'S START WITH THE BOTTOM EMAIL THERE. WE'RE NOW IN MARCH OF 2010; RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND MS. HOLMES WRITES TO YOU. THE SUBJECT IS FOLLOW UP. AND SHE SAYS "CONNIE -- "CAROLYN LET ME KNOW YOU TWO CONNECTED" -- THAT WOULD BE CAROLYN BALKENHOL, DO YOU EXPECT?
CONSTANCE CULLEN: I WOULD EXPECT.
MR. CLINE: -- "I AM REALLY LOOKING FORWARD TO OUR NEXT CONVERSATION. PLEASE LET ME KNOW IF THERE IS ANYTHING WE CAN DO FROM OUR END TO HELP FACILITATE THINGS MOVING FORWARD IN THE MEANTIME." THEN SHE SAYS CONGRATULATIONS ON YOUR NEW ROLE WHERE YOU HAD MORE RESPONSIBILITY BUT NO PROMOTION, "I WAS HAPPY TO HEAR ABOUT IT."
CONSTANCE CULLEN: YES.
MR. CLINE: AND YOU WRITE BACK THE NEXT DAY AND SAY "HI ELIZABETH. "THANKS FOR THE NOTE BELOW. THINGS WILL SETTLE DOWN EVENTUALLY. IN THE MEANTIME, I'VE ASKED A SCIENTIST FROM MY GROUP (DON LEE) TO REACH OUT TO GARY TO DISCUSS THE SPECIFICS OF THE VALIDATION." DO YOU SEE THAT?
CONSTANCE CULLEN: I DO.
MR. CLINE: NOW, WOULD IT BE DR. LEE, THE SCIENTIST?
CONSTANCE CULLEN: IT WAS NOT DR. LEE.
MR. CLINE: MR. LEE?
CONSTANCE CULLEN: MR. LEE.
MR. CLINE: DID MR. LEE REACH OUT TO GARY, DO YOU KNOW?
CONSTANCE CULLEN: I DON'T KNOW.
MR. CLINE: AND I TAKE IT YOU HAD SO MUCH GOING ON, I TAKE IT YOU DIDN'T FOLLOW UP ON THIS?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: AND MS. HOLMES SIX DAYS LATER WRITES AGAIN AND SHE SAYS, "THANKS CONNIE. PLEASE LET ME KNOW IF THERE IS ANYTHING WE CAN DO ON OUR END TO HELP FACILITATE THIS." RIGHT?
CONSTANCE CULLEN: CORRECT.
MR. CLINE: AND IS IT FAIR TO SAY THAT, FROM THE BEST OF YOUR RECOLLECTION SITTING HERE TODAY, THAT THAT'S THE LAST COMMUNICATION THAT YOU HAD WITH MS. HOLMES?
CONSTANCE CULLEN: THAT'S PROBABLY CORRECT, BUT I CAN'T SAY FOR SURE.
MR. CLINE: ALL RIGHT. YOU WERE ASKED ON DIRECT IF YOU HAD EVER TOLD ANYONE AT THERANOS THAT THE REPORT THAT WAS SENT TO YOU BY MR. FRENZEL IN DECEMBER WAS, WAS ACCURATE, GOOD, BAD, WHATEVER. AND THE ANSWER WAS THAT YOU HAD NOT TOLD ANYONE AT THERANOS THAT; RIGHT?
CONSTANCE CULLEN: THAT'S CORRECT.
MR. CLINE: YOU SIMILARLY DIDN'T TELL ANYONE AT THERANOS THAT THERE WERE ANY PROBLEMS WITH THE REPORT; RIGHT?
CONSTANCE CULLEN: THAT IS CORRECT.
MR. CLINE: YOU JUST DIDN'T RESPOND AT ALL IN THE END; RIGHT?
CONSTANCE CULLEN: THAT IS CORRECT.
MR. CLINE: ALL RIGHT. THAT'S ALL OF MY QUESTIONS, YOUR HONOR. THANK YOU, YOUR HONOR. THANK YOU, DR. CULLEN.
JUDGE DAVILA: MR. SCHENK?
MR. SCHENK: NO FURTHER QUESTIONS.
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MR. SCHENK: YES.
MR. CLINE: YES.
JUDGE DAVILA: YOU'RE EXCUSED.
CONSTANCE CULLEN: THANK YOU.
JUDGE DAVILA: YOU'RE WELCOME. FOLKS, FEEL FREE TO STAND AND STRETCH FOR A MOMENT WHILE WE GET READY FOR THE NEXT WITNESS.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: ARE WE BREAKING AT 1:30? IS THAT RIGHT?
MS. TREFZ: YES.
JUDGE DAVILA: SO, LADIES AND GENTLEMEN, WE'LL TAKE OUR NEXT BREAK AT 1:30, AT THE BOTTOM OF THE HOUR. BUT I THINK THAT THE GOVERNMENT HAS A WITNESS TO CALL IN THE INTERIM.
MR. SCHENK: YES. YOUR HONOR, THE UNITED STATES CALLS DANIEL MOSLEY.
JUDGE DAVILA: SIR, IF YOU WOULD JUST COME FORWARD HERE, AND IF YOU WOULD FACE OUR COURTROOM DEPUTY WHILE YOU RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
(GOVERNMENT'S WITNESS, DANIEL MOSLEY, WAS SWORN.)
CONSTANCE CULLEN: YES.
JUDGE DAVILA: PLEASE HAVE A SEAT UP HERE, SIR. MAKE YOURSELF COMFORTABLE.
CONSTANCE CULLEN: THANK YOU.
JUDGE DAVILA: YOU'RE WELCOME. FEEL FREE TO ADJUST THE CHAIR AND MICROPHONE AS YOU NEED.
CONSTANCE CULLEN: OKAY.
JUDGE DAVILA: AND WHEN YOU ARE COMFORTABLE, I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE, AND PLEASE STATE YOUR NAME.
CONSTANCE CULLEN: OKAY. DANIEL LYNN MOSLEY.
JUDGE DAVILA: THANK YOU. COULD YOU SPELL THAT FOR US, PLEASE.
CONSTANCE CULLEN: M-O-S-L-E-Y.
JUDGE DAVILA: THANK YOU. MR. SCHENK.