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Product Information and Testing - Amended ©2008 WiCell Research Institute The material provided under this certificate has been subjected to the tests specified and the results and data described herein are accurate based on WiCell's reasonable knowledge and belief. Appropriate Biosafety Level practices and universal precautions should always be used with this material. For clarity, the foregoing is governed solely by WiCell’s Terms and Conditions of Service, which can be found at http://www.wicell.org/privacyandterms. Product Information Testing Performed by WiCell Test Description Test Provider Test Method Test Specification Result Post-Thaw Viable Cell Recovery WiCell SOP-CH-305 15 Undifferentiated Colonies, 30% Differentiation Pass Identity by STR UW Molecular Diagnostics Laboratory PowerPlex 1.2 System by Promega Match Pass Sterility - Direct transfer method Apptec 30744 No contamination detected Pass Mycoplasma Apptec 30055 No contamination detected Pass Karyotype by G-banding WiCell SOP-CH-003 Normal karyotype Pass Flow Cytometry for ESC Marker Expression UW Flow Cytometry Laboratory SOP-CH-101 SOP-CH-102 SOP-CH-103 SOP-CH-105 Report - no specification See report Product Name UC06 Lot Number UC06-DL-01 Parent Material UC06-MCB-03 Depositor University of California – San Francisco Banked by WiCell Thaw Recommendation Thaw 1 vial into 1 well of a 6 well plate. Culture Platform Feeder Dependent Medium: hES Medium Matrix: MEF Protocol WiCell Feeder Dependent Protocol Passage Number p62 These cells were cultured for 61 passages prior to freeze. WiCell adds +1 to the passage number at freeze so that the number on the vial best represents the overall passage number of the cells at thaw. Date Vialed 01-May-2008 Vial Label UC06-DL-1 p62 MW 1 MAY 2008 SOPCC035D Biosafety and Use Information Appropriate biosafety precautions should be followed when working with these cells. The end user is responsible for ensuring that the cells are handled and stored in an appropriate manner. WiCell is not responsible for damages or injuries that may result from the use of these cells. Cells distributed by WiCell are intended for research purposes only and are not intended for use in humans.

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Product Information and Testing - Amended

©2008 WiCell Research Institute The material provided under this certificate has been subjected to the tests specified and the results and data described herein are accurate based on WiCell's reasonable knowledge and belief.  Appropriate Biosafety Level practices and universal precautions should always be used with this material.  For clarity, the foregoing is governed solely by WiCell’s Terms and Conditions of Service, which can be found at http://www.wicell.org/privacyandterms. 

Product Information

Testing Performed by WiCell

Test Description Test Provider Test Method Test Specification Result

Post-Thaw Viable Cell Recovery WiCell SOP-CH-305 ≥ 15 Undifferentiated Colonies, ≤ 30% Differentiation Pass

Identity by STR UW Molecular Diagnostics Laboratory

PowerPlex 1.2 System by Promega

Match Pass

Sterility - Direct transfer method Apptec 30744 No contamination detected Pass Mycoplasma Apptec 30055 No contamination detected Pass Karyotype by G-banding WiCell SOP-CH-003 Normal karyotype Pass Flow Cytometry for ESC Marker Expression

UW Flow Cytometry Laboratory

SOP-CH-101 SOP-CH-102 SOP-CH-103 SOP-CH-105

Report - no specification See report

Product Name UC06 Lot Number UC06-DL-01 Parent Material UC06-MCB-03 Depositor University of California – San Francisco Banked by WiCell Thaw Recommendation Thaw 1 vial into 1 well of a 6 well plate. Culture Platform Feeder Dependent

Medium: hES Medium

Matrix: MEF

Protocol WiCell Feeder Dependent Protocol Passage Number p62

These cells were cultured for 61 passages prior to freeze. WiCell adds +1 to the passage number at freeze so that the number on the vial best represents the overall passage number of the cells at thaw.

Date Vialed 01-May-2008

Vial Label UC06-DL-1 p62 MW 1 MAY 2008 SOPCC035D

Biosafety and Use Information Appropriate biosafety precautions should be followed when working with these cells. The end user is responsible for ensuring that the cells are handled and stored in an appropriate manner. WiCell is not responsible for damages or injuries that may result from the use of these cells. Cells distributed by WiCell are intended for research purposes only and are not intended for use in humans.

Product Information and Testing - Amended

©2008 WiCell Research Institute The material provided under this certificate has been subjected to the tests specified and the results and data described herein are accurate based on WiCell's reasonable knowledge and belief.  Appropriate Biosafety Level practices and universal precautions should always be used with this material.  For clarity, the foregoing is governed solely by WiCell’s Terms and Conditions of Service, which can be found at http://www.wicell.org/privacyandterms. 

Amendment(s): Reason for Amendment Date

CoA updated to include copyright information. See signature

CoA updated for format changes, including adding fields of thaw recommendation, vial label, protocol, and banked by, and removal of footnotes. 28-JUN-2013

CoA updated to correct mycoplasma testing provider and test method. 07-SEP-2010

CoA updated for format changes, clarification of test specifications, test method, addition of test provider, culture platform, and electronic signature, and reference to WiCell instead of the NSCB 28-JUL-2010

Original CoA 11-AUG-2008

Date of Lot Release Quality Assurance Approval

11-August-2008

12/31/2013

X AMCAMCQuality AssuranceSigned by:  

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Copy of OriginalReport

FINAL STUDY REPOR T

MYCOPLASWIA DETECTION:"Points to Consider"

STUDY TITLE:

PROTOCOL NUMBER : 30055E

TEST ARTICLE IDENTIFICATION: UC06-DL-1

WiCeli Research InstituteSPONSOR:

WuXi AppTec, inc .PERFORMING LABORATORY :

STUDY NUMBER : 106021

Considered negative for mycoplasmacontamination

RESULT SUMMARY:

Reference PO # RP1869

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Page 2 of 9Study Number: 10602 1Protocol Number: 30055 E

Copy of Original

QUALITY ASSURANCE UNIT SUMMARY

STUDY: Mycoplasma Detection : "Point s to Consider"

The objectiv e o f th e Qualit y Assuranc e Uni t i s t o monito r th e conduc t an d reportin g o f nonciinica llaboratory studies Thi s study has been performed under Good Laboratory Practice s regulations (FDA,21 CFR, Par t 58 - Good Laborator y Practic e for Nonclinica ! Laboratory Studies ) and i n accordance tostandard operating procedures and a standard protoco l Th e Quality Assurance Uni t maintains copiesof study protocol s and standard operating procedures and has inspected this study on the dates listedbelow. Studie s are inspected at time intervals to assure the quality and integrity of the study.

Management06/12/0806/12/08

Studv Director05/20/0806/11/08

Date05/12/0806/11/08

Critical PhaseStainingFinal Repor t

The findings o f these inspections have been reported to management and the Study Director

^1 ('^(o-fQuality Assurance Auditor , Date:

GOOD LABORATORY PRACTICE S STATEMENT

The study referenced in this report was conducted in compliance with U S Foo d and Drug AdministrationGood Laboratory Practice {GLP) regulations set forth in 21 CF R part 58

The studies not performed by or under the direction of WuXI AppTec, Inc , are exempt from this GoodLaboratory Practic e Statement and include characterization and stability of the test compound{s)/tes tarticle

Study Director : Date: 6='//2/^P

Professional Personne l Involved:Vice President of St Pau l OperationsManager, Mycoplasm a Testing Laborator yStudy Directo rClient Relations Manage r

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Page 3 of 9Study Number : 10602 1

Protocol Number: 30055 E

Copy of OriginalPURPOSETo demonstrat e tha t a test articl e consistin g o f a cel l bank , productio n o r seed lots , o r ra wmaterials is free of mycoplasmal contamination, according to "Points to Consider" criteria

10

SPONSOR: WiCell Research Institute

WuXi AppTec, Inc.

2,0

TEST FACILITY:3 0

SCHEDULING40

DATE SAMPLE RECEIVED: 05/07/0 8STUDY INITIATION DATE: 05/08/0 8STUDY COMPLETION DATE: 06/12/0 8

TEST ARTICLE IDENTIFICATION: WiCel l Research Institute ; UC06-DL-1

SAMPLE STORAGEUpon receip t b y th e Sampl e Receivin g Department , th e tes t sample s were place d i n adesignated, controlle d acces s storag e are a ensurin g prope r temperatur e condition s Tes tand contro l articl e storag e area s ar e designe d t o preclud e th e possibilit y o f mix-ups ,contamination, deterioratio n o r damag e Th e sample s remaine d i n th e storag e are a unti lretrieved b y th e technicia n fo r sampl e preparatio n and/o r testin g Unuse d tes t sample sremained in the storage area unti l the study was completed Onc e completed, the remainin gsamples were discarded or returned as requested by the Sponsor

TEST ARTICLE CHARACTERIZATIO NThe Sponsor was responsible fo r al l test article characterization dat a as specified in the GLPregulations Th e identity , strength , stability , purity , an d chemica l compositio n o f th e tes tarticle wer e solel y th e responsibilit y o f th e Sponsor , Th e Sponso r wa s responsibl e fo rsupplying t o the testin g laborator y result s o f these determination s an d an y other s tha t ma yhave directl y impacte d th e testin g performe d b y th e testin g laboratory , prio r t o initiatio n o ftesting. Furthermore , i t was th e responsibilit y o f the Sponso r t o ensure tha t the tes t articl esubmitted fo r testing was representativ e o f the fina l produc t tha t was subjected t o material scharacterization An y special requirements for handling or storage were arranged in advanceof receipt and the test article was received in good condition

The Vero ceils were maintained by WuXi AppTec's Cell Production Laborator y

EXPERIMENTAL DESIG N

8.1 Overvie wWhereas no single test is capable of detecting ail mycoplasmal strains, freedom frommycoplasmal contamination may be demonstrated b y the use of bcth an indirect anddirect procedure

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Page 4 of 9Study Number: 10602 1Protocol Number : 30055 E

Copy of Original8,2 Justificatio n for Selection of the Test System

Contamination o f cel l culture s b y mycoplasm a i s a commo n occurrenc e an d i scapable o f alterin g norma l cel l structur e an d functio n Amon g othe r things ,mycopiasma ma y affeo t cel l antigenioity , interfer e wit h viru s replication , an d mimi cvirai actions. Testin g for the presence of mycoplasm a fo r cel l lines used to producebiologicais i s recommende d b y th e FDA , Cente r fo r Biologie s Evaluatio n an dResearch (CBER) under "Points to Consider "

9.0 EXPERIiMENTA L SUMMARYThe indirec t metho d o f detectio n allow s visualizatio n o f mycoplasma , particularl y non -cultivable strains, by growing the mycoplasma on an indicator cei l line and then staining usinga DNA-bindin g fluorochrom e stai n Th e indicato r cel l lin e shoul d b e eas y t o grow , hav e alarge cytoplasmi c t o nuclea r are a rati o an d suppor t th e grovirt h o f a broa d spectru m o fmycopiasma specie s Th e African gree n monke y kidne y cel l line , Vero, fit s thi s descriptio nand was use d i n this assay Th e assay was performe d with negativ e an d positiv e control sBoth a strongl y cyto-adsorbin g (M . hyorhinis) an d a poorl y cyto-adsorbin g {M orale)mycoplasma specie s wer e use d a s positiv e control s Poo r cyto-adsorbin g mycopiasm aspecies ma y no t giv e reliabl e positiv e result s whe n inoculate d i n lo w number s A secon ddilution o f M. orate wa s use d t o ensur e cyto-adsorptio n Stainin g th e culture s wit hDNA binding fluorochrom e allow s fo r th e detectio n o f mycoplasm a base d o n th e stainin gpattern observed Onl y the cel l nucle i demonstrate fluorescence i n the negative cultures bu tnuclear and extra-nuclear fluorescence i s observed in positive cultures

Direct cultivatio n i s a sensitiv e an d specifi c metho d fo r th e detectio n o f mycoplasm a Th eagar an d brot h medi a employe d suppl y nutrient s necessar y fo r th e growt h o f cultivabl emycoplasmas Thes e medi a als o suppl y a sourc e o f carbon an d energy , an d favorabl egrowth conditions Th e direct assay was performed with both negative and positive control sA fermentative mycoplasma (M. pneumoniae) and a non-fermentative mycoplasm a (M orale)were use d a s positiv e control s Th e procedur e employe d i n thi s stud y i s base d o n th eprotocol describe d i n th e 199 3 Attachmen t # 2 t o th e "Point s T o Consider " document , a srecommended by the FDA, Center for Biologies Evaluation and Research (CBER)

10 0 TES T MATERiAL PREPARATiO N

10 1 Tes t Articie identification:

Test Article Name:General Description:Number of Aliquots used:Stability (Expiration) :Storage Conditions:Safety Precautions :

UC06-DL-1hES cells1 X 15 mLNot GivenUitracold (< -60°C)BSL-1

10,2 Tes t Sample Preparatio nThe test article was thawed in a water bath at 37 ± 2°C and 1: 5 and 1:1 0 dilution s ofthe test artici e were prepare d i n sterile phosphat e buffere d saiin e (PBS) . 1 0 mL ofthe undilute d sample , th e 1: 5 an d 1:1 0 dilution s wer e the n inoculate d ont o eac h o ftwo (2 ) ooverslip s (pe r sample/dilution ) containin g Ver o cells . Th e coverslip s wer eincubated in incubator E77 0 for 1-2 hours at 37 ± rc / 5 ± 2% CO2 and then 2.0 mLof EMEM , 8 % Feta l Bovin e Seru m (FBS ) wa s adde d t o eac h coversli p Th eooverslips wer e returne d t o incubato r E77 0 a t 3 7 ± r C / 5 ± 2% CO2. Afte r thre edays o f incubation , th e coverslip s wer e fixed , stained , an d the n rea d usin g a nepifiuorescent microscop e

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Study Number : 10602 1Protocol Number: 30055 E

Copy of Original0.2 m L o f the undilute d tes t article was the n inoculate d ont o each of two SP- 4 agarplates, an d 1 0 0 m L wa s inoculate d int o a 7 5 cm ^ flas k containin g 5 0 mL o fSP-4 broth Th e plate s were placed i n an anaerobic GasPa k system and incubate dat36± 1° C fora minimum of 14 days.

The brot h flask was incubated aerobicaii y a t 36 ± 1°C , and subcuitured ont o each oftwo SP-4 agar plate s (0 2 mL/plate ) o n Day s 3 , 7 , and 1 4 Thes e subculture plate swere place d i n a n anaerobi c GasPa k syste m an d incubate d a t 36 + I^ C fo r aminimum o f 1 4 days Th e brot h flask was rea d each working da y for 1 4 days Th eSP-4 aga r plate s (Da y 0 ) wer e rea d afte r 1 4 days o f incubatio n Th e SP- 4 brot hsubculture plates {Days 3, 7, and 14) were read after 14 days incubation

10.3 Control s and Reference Material s

10,.3,.1 Steril e SP-4 broth served as the negative control for both the direct andindirect assays

10 3,2 Positiv e Controls

a, Indirec t Assay

a,,1 Strongl y cyto-adscrbin g specie s - M hyorhinis GD L(ATCC #23839) a t 10 0 o r fewe r colon y formin g unit s (CFU )per inoculum

a.,2 Poorl y cyto-adsorbin g specie s - M orale (ATCC #23714) a t100 o r fewe r CF U an d a t approximatel y 10 0 ID5 0 pe rinoculum

b:. Direc t Assay

b,.1 Nonfermentativ e mycoplasm a specie s - M(ATCC #23714) at 100 cr fewer CFU per inoculum

b,.2 Fermentativ e mycoplasm a specie s - M pneumoniae F H(ATCC #15531) at 100 or fewer CFU per inoculum

orale

10 3.3 Contro l Preparation

a. Negativ e Controls

a,,1 1. 0 mL of sterile SP-4 broth was inoculated onto each of two(2) coverslips containin g Vero cells tc serv e as the negativ econtrol in the indirect assay

a,.2 0 2 m L o f SP- 4 brot h wa s inoculate d ont o eac h o f tw o (2 )SP-4 aga r plate s t o serv e a s th e negativ e contro l i n th edirect assa y 1 0 0 m L o f SP- 4 brot h was inoculate d int o a75 cm^ flask containing 5 0 mL of SP-4 brot h to serve as thenegative control in the direct assay

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Protocol Number : 30055 E Pag e 6 of 9

Copy of OriginalPositive Controls

b,,1 M. hyorhinis, M orale, an d M pneumoniae wer e dilute d t oless tha n 10 0 CF U pe r inoculu m i n sterii e SP- 4 brot h1 0 mL o f M hyorhinis an d M . oral e a t les s tha n100 CFU/mL was inoculated onto each of two (2 ) coverslip scontaining Ver o cell s 1 0 m L o f M oraie a t 10 0 iDs o CFUper inoculu m wa s als o inoculate d ont o eac h o f tw o (2 )coverslips containing Vero cells Thes e coversiips served asthe positive controls in the indirect assay

b,,2 Th e coverslip s wer e incubate d i n incubato r E77 0 fo r1-2 hour s a t 37 ± r c / 5 ± 2 % CO 2 an d the n 2 0 m L o fEiVlEM, 8 % Feta ! Bovin e Seru m (FBS ) wa s adde d t o eac hcoverslip. Th e coverslips were returned to incubator E770 at37 ± 1° C / 5 ± 2% CO2. Afte r thre e days of incubation , thecell culture s wer e fixed , stained , an d the n rea d usin g a nepifiuorescent microscop e

b.,3 0 2 m L o f M. orale an d M pneumor)iae a t les s tha n100CFU/plate wa s inoculate d ont o eac h o f tw o (2 ) SP- 4agar plates 1 0 0 mL of M orale and M pneumoniae a t lessthan 1 0 CFU/mL {<100 CFU/inoculum) wer e each inoculate dinto a 75 cm^flask containing 50 mL of sterile SP-4 broth

b,,4 Th e aga r plate s wer e place d i n a n anaerobi c GasPa ksystem an d incubate d a t 3 6 ± 1° C fo r 1 4 days Th e brot hcultures wer e incubate d aerobicall y a t 3 6 ± 1° C fo r aminimum o f 1 4 day s an d wer e rea d eac h workin g da y fo r14 days. O n Day s 3 , 7 , an d 14 , 0 2mL fro m eac h brot hculture flask was subcultured onto each of two (2) SP-4 agarplates Thes e subculture plates were placed in an anaerobicGasPak syste m an d incubated a t 3 6 ± 1° C Th e subcultur eplates wer e observe d microscopicall y fo r th e presenc e o fmycoplasma colonie s afte r a minimu m o f 1 4 day sincubation

c. Se e Section 1 5 0, Results, for the results of these controls

11,0 DAT A ANALYSISThe result s o f thi s stud y wer e base d o n visua l observations , therefore , n o dat a analysi s wa srequired

12 0 STATISTICA L METHODSThe resuits of this study were qualitative, therefore, no statistical analysis was required

WiCel! Research Institute

Page 7 of 9Study Number : 10602 1Protocol Number: 30055 E

Copy of OriginalEVALUATrON CRITERIAFinal evaluation o f the validity o f the assay an d test article result s was base d upo n the criterialisted belovi/ and scientific judgment

13 0

Indirect Assa y

DETECTION OF WIYCOPLASMA CONTAMINATION B Y INDIRECT ASSAY

13.1

CONTROLS

Negative ControlM. hyorhinisM.orale (<100CFU )M.orale (IOOID50 )

WIYCOPLASMA FLUORESCENC E OBSERVE D{AT LEAS T ONE COVERSLIP REQUIRED FOR THE EVALUATION)

-+

+"Mycoplasma mus t be observed for at least one dilution of the poorly cyto-adsorbing mycopiasma species M orale

Direct Assay

DETECTION OF WIYCOPLASMA CONTAMINATION BY DIRECT ASSAY

13,2

Broth (Colo r change or turbidity change)Agar Day 0 (at least one plate)Agar Day 3, 7, 14 (a t least one plate onone day)Results

NEGATIVECONTROL

--

-

-

M..PNEUMONIAE

+ / -+

+

+

M. ORALE

+ / -

+

+

14 0 TES T EVALUATION

14.1 Indirec t Assa yHoechst stain will bin d to mos t DN A containing organisms an d organelles presen t inthe culture; this includes indicato r cel l nuclei , prokaryotes includin g mycopiasm a an dceil debris Th e source of DN A i s determined b y the staining patter n Th e indicato rcell nucle i fluoresc e brightl y an d ar e generall y 10-2 0 ^m i n diamete r Mycopiasm afluorescence i s les s intense , i s extra-nuclea r an d typicall y appear s a s smal l roun dbodies approximately 0 3 j m in diameter

14.2 Direc t Assa yChange i n colo r o r turbidit y o f brot h cultur e ca n b e an indicato r o f th e presenc e o fmycopiasma growt h Fermentativ e mycopiasm a produc e aci d fro m th ecarbohydrates i n the medium causin g the pH of the medium to drop and the broth toturn yello w i n colo r Nonfermentativ e mycopiasm a produc e ammoni a b y arginin ehydrolysis causin g th e p H t o ris e an d th e brot h t o tur n re d I n general , growt h o fmycopiasma ca n caus e th e brot h t o becom e turbi d Thes e change s mus t b econfirmed by agar piate subculture or DNA-staining since changes in the appearanceof the broth culture can also be caused by the properties of the inoculum

Mycopiasma colonie s gro w dow n int o th e aga r causin g th e cente r o f th e colon y t oappear opaqu e an d th e periphera l surfac e growt h t o appea r translucen t Thes e"fried-egg" colonies vary i n size, 10-50 0 |am , and can be readil y observe d unstaine dusing a light microscope

WiCeli Research InstitutePage 8 of 9

Study Number : 10602 1Protocol Number: 30055 E

Copy of Original14,3 Indirect Assay and Direct Assay Result s

IF:

Mycoplasmal fluorescence

Broth (Colo r change or turbidity change)

Agar - Day 0 (a t least one plate)Agar- Da y 3, 7, 14 (a t least one plateon one day)THEN: OVERAL L FINAL RESULT

Interpretation

TEST ARTICL E

-

-

-

-

-

+

+/-

+/-

+/-

+

+/-

+/-

+/-

+

+

+/-

+/-

+

+/-

-

+*

-

-

-

*A change in the appearance of a broth culture must be confirmed by positive subculture piate(s}

Positive ResultsThe tes t articl e i s considere d positiv e i f th e direc t assa y (aga r o r brot h medi aprocedure) o r the indirec t assa y (indicato r cel l culture procedure ) sho w evidence o fmycoplasma contamination and resemble the positive controls for the procedure.

Negative ResultsThe tes t articl e i s considere d a s negativ e i f bot h th e direc t assa y (aga r an d brot hmedia procedure ) an d the indirec t assa y (indicato r cel l cultur e procedure ) sho w n oevidence o f mycoplasm a contaminatio n an d resembl e th e negativ e contro l fo r eac hprocedure

14.4

14,5

15,0 RESULT SIndirect Assay and Direct Assay Result s

Test Article: UC06-DL-1

Negative Control

M hyorhinis

M. orale

M pneumonlae

INDIRECT

Negative

Negative

Positive

Positive

DIRECTBROTHFLASKS

Negative

Negative

Positive

Positive

AGARPLATES

Negative

Negative

Positive

Positive

OVERALL,

Negative

Negative

Positive

Positive

Positive

For the indirec t assay , th e coverslips fo r the undilute d tes t article were read and determinednegative

16 0 ANALYSI S AND CONCLUSION

16,,1 Th e results of the negative and positive controls indicated the validity of this test

16,,2 Thes e finding s indicate d that the test article , UC06-DL-1 , i s considered negativ e fo rthe presence of mycoplasma contamination

WiCell Research InstitutePage 9 of 9

Study Number; 10602 1Protocol Number: 30Q55 E

Copy of Original17,0 DEVIATIONS : Non e

18,0 AMENDMENTS : Th e study directorship of this project was reassigned to Sheri J Zieiinsk i

19 0 RECOR D RETENTIO NAn exact copy of the original final report and ail raw data pertinen t to this study wiii be storedat WuXi AppTec, In c , 2540 Executiv e Drive , St Paul , MN 5512 0 i t i s the responsibiiit y o fthe Sponsor to retain asampieof the test article

20 0 TECHNICA L REFERENCE S

20,,1 Barile , Miohae i F an d McGarrity , Gerar d J (1983 ) "Isoiatio n o f Mycoplasmas fro mCeil Culture by Agar and Broth Techniques" Method s in Mycoplasmology, Vol II , edJG Tullyand S Razi n {Ne w York: Academic Press) pp 159-16 5

20,.2 De l Giudice , Richar d A an d Josep h G . Tull y 199 6 "isolatio n o f Myooplasm a fro mCeli Culture s b y Axeni c Cultivatio n Techniques, " e d J G Tull y an d S Razin ,Molecular an d Diagnosti c Procedure s i n Mycoplasmology , Vo l I I (Ne w York :Academic Press )

2O.,3 McGarrity , Gerar d J . an d Barile , Michae l F 198 3 "Us e o f Indicato r Cei l Line s fo rRecovery an d Identificatio n o f Cel l Cultur e Mycoplasmas, " ed . J. G Tull y an d SRazin, Methods in Mycoplasmology, Vol I I {New York: Academic Press )

20.4 Masover , Geral d an d France s Becke r 199 6 "Detectio n o f Mycopiasm a b y DN AStaining an d Fluorescen t Antibod y Methodology, " e d J G Tull y an d S Razin ,Molecular an d Diagnosti c Procedure s i n Mycoplasmology , Vo l I I (Ne w York :Academic Press )

20.5 Schmidt , Nathali e J an d Emmons , Richar d W 198 9 "Cel i Cultur e Procedure s fo rDiagnostic Virology, " e d Nathali e J Schmid t an d Richar d W Emmons , 6t h e d ,Diagnostic Procedure s fo r Viral , Rickettsia i an d Chlamydia l Infection s (Washington :American Publi c Health Association)

20,.6 U S Foo d an d Dru g Administratio n {FDA ) Cente r fo r Biologie s Evaluatio n an dResearch (CBER) . 199 3 "Point s t o Conside r i n the Characterizatio n o f Cel l Line sUsed to Produce Biologioals "

Page 1 of 1

WiCell Cytogenetics Report: 000000555555--005511660088 NNSSCCBB 11559944

Report Date: July 28, 2010

Case Details: Cell Line: UUCC0066--DDLL--11 ((NNSSCCBB##11559944))

Passage #: 6655

Date Completed: 55//2288//22000088

Cell Line Gender: female Investigator: MM hh WW

Specimen: hhEESSCC oonn MMEEFF ffeeeeddeerr

Date of Sample: 55//1166//22000088

Tests,Reason for: DDiissttrriibbuuttiioonn LLoott RReelleeaassee TTeessttiinngg,, NNSSCCBB## 11559944

Results: 46,XX

CCoommpplleetteedd bbyy CCSS,, CCLLSSpp((CCGG)),, oonn 55//2288//22000088

RReevviieewweedd aanndd iinntteerrpprreetteedd bbyy KKDDMM,, PPhhDD,, FFAACCMMGG,, oonn 55//2288//22000088 Interpretation: NNoo aabbnnoorrmmaalliittiieess wweerree ddeetteecctteedd aatt tthhee ssttaatteedd bbaanndd lleevveell ooff rreessoolluuttiioonn..

Cell: SS0011--0033

Slide: BB

Slide Type: KKaarryyoottyyppiinngg

Cell Results: KKaarryyoottyyppee:: 4466,,XXXX

# of Cells Counted: 20

# of Cells Karyotyped: 4

# of Cells Analyzed: 8

Band Level: 450-600

Results Transmitted by Fax / Email / Post Date:__________________________ Sent By:____________________________ Sent To:_______________________

Procedures performed: Cell Line: UC06-DL-1 Date of: (mm/dd/yy) SOP-CH-101 SOP-CH-102 Passage P 67 acquisition: 06/03/08 SOP-CH-103 SOP-CH-105 Sample ID: 1594-FAC file creation: 06/08/08 file submission: 08/01/08

SSEA4 - SSEA4 + SSEA4 + SSEA4 - ALL ALL antigen2: antigen2 + antigen2 + antigen2 - antigen2 - SSEA4 + antigen2 + SSEA3 0.49 60.60 37.40 1.56 98.00 61.09 TRA1-60 0.32 66.40 31.60 1.61 98.00 66.72 TRA1-81 0.30 53.40 44.50 1.77 97.90 53.70 Oct-4 0.59 71.20 25.00 3.14 96.20 71.79 SSEA1 0.40 8.95 88.80 1.85 97.75 9.35

0.00

20.00

40.00

60.00

80.00

100.00

120.00

SSEA3 TRA1-60 TRA1-81 Oct-4 SSEA1

Perc

en

tag

e C

ells P

osit

ive

SSEA4 +

antigen2 +

100 101 102 103 104

APC C-A: BD Oct-4

100

101

102

103

104

PE

D-A

: SS

EA

4

0.59 71.2

253.14

**PE-conjugated Oct-3/4 from BD Biosciences was used (cat #560186).