[+] CPLCONTRACT PHARMACEUTICALS LIMITED7600 Danbro CrescentMississauga, OntarioLSN6L6

Phone (905) 821-7600Fax (905)542-9224

Certificate of Manufacturing Compliance

To: Bristol-Myers Squibb

Product: 1 P_I_as_t_ib_as_e_5_0_W .•.•CPLProduct No.: 5003495--------------------Manufacturing Lot No. 74589--------------------

Date of Manufacture: December 20, 2011 Expiry Date:Quantity Released (kg): 1150.0 Manufacturing Order Revision No.

------------Deviation(s): Yes ~ No 0

Title: DMI-GR-ll-0161, DMI-GR-ll-0166

121141

Incident Report(s): Yes ~ No 0Title: IR-GR-II-0053

FINAL APPROVAL

This batch has been manufactured according to Good Manufacturing Practicesand documents have been verified.

Authorization:

Title: rosn Date:

FQC-024.FO

~CPL1 of 1

Laboratory ServicesCERTIFICATE OF ANALYSIS

Client: Contract Pharmaceuticals Ud. I Client 10: 2045 Revised Date: 02124/12Original Date: 02117112

Address: 7600 Danbro Crescent, Mlssissauga, Ontario l5N 616 IP#: 78969-78974

Contact Allyson Pearson I Phone: 905-821-7600 Fax: 905-821·0386Person:ProductName: PlasUbase SOW (Finished Product) Batch No.: 74589

lResults below are average of beginning. middle and Customer Lot No.: 74589end samples from validation lot 74589·Discharge#1

2 Result below Is average of beginning, middle and end Manufacturer's Lot No.: NfA

samples from valldatlon lot 74589-Dlscharge#1 and

Comments: DIscharge#2 CPL Material No.: 5003495

3 Results below are observed in each of beginning,middle and end samples from validation lot 74589-Dlscharge#1. P.O. No.: NJA

Summary Validation Report V·788PR·0·SUM

Revision#' 01

TEST I METHOD SPECIFICATION RESULT

Smooth, uniform, translucent, soft, Smooth, uniform, translucent, soli, grease·grease-like mass, free from visibleDescription 3 impurities. White in bulk, practically like mass. free from visible Impurities. While

<GM·D1> colourless In thin layers. Odourless or In bulk; practically colourless In thin layers.

slightly paraffin-like. Must not feel gritty Odourless. Old not feel gritty when rubbed

when rubbed between the Hnllers between the lingers

Polyethylene Content 1 4.50-5.50% 4.96%<249796(8» (90-110% of theory, 5%) (99% of theory)

Acidity or Alkallnitl Must be neutral 10 litmus paper Conforms<000420(S»

Bleed Test INMTO.100g

<249797(8» The weIght of oil separated must not 0.0849exceed 0.1000

Heat Stabllity 3 The sides of the cone must show no Conforms<000732(8» more than a slight curvature

SpeCific Gravity t 0.87()"0.920 0.880<249798(8»

Consistency 2Procedure B 250-320 258 (tenth of a mm)<OO95(G»

Metal Particles! NMT 3 particles/sample o particles/sample<0282(G»

Reviewed By: t.W:udl,.~ Dale: kj,h,/n- Approved By: (?I{,~.(t l\tuko.t'Date: D~\)..~I8LQua! Assurance

CPL Laboratory Services1 Valleywood Drive, Suite 100. Markham, Ontario l3R 5L9T] 905.470.2028 FJ 905.470.9241 WI www.cptnc.com

1 VaJJeywood Drive, SIite 100, Markham, Ontario.L3R 5L9 Tel. (005) 470-2028 Fax. (905) 470-9241 DfaCPL

.Laboratory Services

Certificate of Analysis Page 1 of 1

Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1116/2012

Material Number: :5003495"J'i...-- ..•- ... ".

Testing POt: N1A

Specification Revision #::-1~-..... . - -\ .... -

IP #: 78969Tests Required: FULL

-...COA Revision #: .. 0 ...

Product: Plastibase 50W (Finished Product) 1249084

Batch #: 74589 Lot #: !z45S'9""1\. ... - ... J

Test Started: 01/03/2012 Test Completed: 01/10/2012

TESTIMtn"HOD SPECIFICATIONIUNIT .1 RESULTIUNIT

DescriptionGM-D1

Smooth, uniform, translucent, Smooth. uniform,soft, grease-like mass, free translucent, soft, grease-likefrom visible impurities. White in mass, free from visiblebulk; practically colourless in Impurities. White in butk~thin layers. odourless or slightly practically colourless in thinparafiin-like. Must not feel gritty layers. Odourless. Old notwhen rubbed between the feel gritty when rubbedfingers. between the fingers

Polyethylene Content249796{S)

4.50 - 5.50% (90 - 110% of 4.90% (98% of Theory)theory, 5%)

Acidity or Alkalinity000420(5)

Must be neutral to litmus paper. Conforms

Bleed Test249797(5)

NMT 0.100 g. The weight of oil 0.093gseparated must not exceed0.1OOg

Heat Stability000732(5)

The sides of the cone must Conformsshow no more than a slightcurvature

Specific Gravity249798 (5)

0.870-0.920 0.879

Consistency0095 (G)

250-320 (Approved Limits).260-300 (Caution Limits)

Average (n=3): 260

Metal Particles0282 (G)

NMT 3 particles/sample o particle/sample

Comments:Individual testing on B/M1E samples. B.eginning. (Discharged11). Validation Batch (V-788PR-Q)\._._........ .. ~

APpnOVED EY QUf-l.tliY

....~~~:rI1/d'"Ll~Auth0rjzsd SignaturGjO~

1 Valleywood Drive, S!.ite 100, MarId18111.ontarloL3R 51.9Tel. (005) 470·2028 Fax. (905) 410-9241 [.]1CPL

L.aboratory Services

Certificate of Analysis Page 1 of 1

Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1116/2012

Material Number: 5003495

Testing POI: NlA

Specification Revision #: 1 -. _.. - -....------ ..-

IP#: 78970Tests Required: FULLCOA Revision #:.. --0 --

Product: Plastibase SOW (Finished Product) 1249084Batch #: 74589 Lot#: 74589

Test Started: 01/03/2012 Test Completed: 01/10/2012

TESTIMETHOD SPECIFICATIONIUNIT!i RESULTIUNIT

DescriptionGM-D1

Smooth, uniform, translucent, Smooth, uniform,soft, grease-like mass, free translucent, soft, grease-likefrom visible impurities. White in mass, free from visiblebulk; practically colourless in impurities. White in bulk;thin layers. odourless or slightly practically colourJessin thinparafiin-like. Must not feel gritty layers. Odourless. Did notwhen rubbed between the feel gritty when rubbedfingers. between the fingers

PolyethyleneContent249796(S)

4.50 ~5.50% {90 ~110% of 4.98% (100% of Theory)theory, 5%)

Acidity or Alkalinity000420(8)

Must be neutral to litmus paper. Conforms

Bleed Test249797(8)

NMT 0.100 9. The weight of oil 0.097gseparated must not exceedO.1OOg

Heat Stability000732(S)

The sides of the cone must Conformsshow no more than a slight-curvature

Specific Gravity249798(S)

0.870-0.920 0.881

Consistency0095 (G)

250-320 (Approved Limits).260-300 (Caution limits)

Average (n=3): 258

Metal Particles0282 (G)

NMT 3 particles/sample 1 particle/sample

Comments:Individual testing on BJMIE samples. ~Iddle: (D.iScharg(;d·1");validatlon Batch (V-788PR-o)

"'-' ....

APPi10VED ev C.UAUTY

.J3'..~~l\r~Authorized S!gnaiure/Date

1 VaIleywood Drive, Suite 100, Markflem. onterloL3R 5L9 Tel. (OOS)470-2028 Fax. (905) ·470-9241 C.l CPL

Laboratory Services

Certificate of Analysis Page 1 of 1

Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/16/2012

Material Number: 5003495

Testing POI: N/A

Spec.ificatlon Revision #: 1

IPi:Tests Required:

COA Revision #: .

78971FULLo

Product: Plastibase 50W (Finished Product) 1249084

Batch l#: 74589 l.ot #: 74589

Test Started: 01/0312012 Test Completed: 01/10/2012

TESTIMETHOD SPECIFICATIONIUNIT I RESULTIUNrr

DescriptionGM-D1

Smooth, uniform, translucent, Smooth, uniform,soft, grease-like mass, free translucent, soft, grease-likefrom visible impurities. White In mass, free from visiblebulk; practically colourless in impurities. White in bulk;thin layers. odourless or slightly practically colourless in thinparafiin-like. Must not feel gritty layers. Odourless. Did notwhen rubbed between the feel gritty when rubbedfingers. between the fingers

PolyethyleneContent249796(S)

4.50 - 5.50% (90 • 110% of 4.99% (100% of Theory)theory, 5%)

Acidity or Alkalinity000420(5)

Must be neutral to litmus paper. Conforms

Bleed Test249797(5)

NMT 0.100 g, The weight of oil 0.061gseparated must not exceed0.100g

Heat Stability000732(5)

The sides of the cone must Conformsshow no more than a slightcurvature

Specific Gravity249798 (S)

0.870-0.920 0.880

Consistency0095 (G)

250-320 (Approved Limits), Average (n=3): 259260-300 (Caution Limits)

Metal Particles0282 (G)

NMT 3 particles/sample 0 particle/sample

Comments:Individual testing on BIM/E samples.End. "(OlSChargE(i-1) Validation Batch (V-788PR.()

'.•""" .••. .... .•. .. J

F.PPR~VEf) e~FQ!J(.\UTY

_~_4..J'.k.· :»tIe-I! 1:p.utr,orizGd Signature/Date

t Valeywood Drive, Stite 100, Markham, OrtarloL3R SL9 Tel. (905) 470-2028 Fax. (905) 470-9241 [.•] CPL

Laboratory Services

Certificate of Analysis Page 1 of 1

Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/16/2012

Material Number: ~O:Q~95'j

Testing POI: N/A

. Specification Revision #: <:J"} .

IP #:Tests Required:

. ·..COA.Revislon.#:

78972REDUCED0 ...

Product: Plastibase 50W (Finished Product) 1249084Batch #: 74589

Test Started: 01/1212012 Test Completed: 01/1212012

TEST/METHOD SPECIFICATIONIUNITI

i RESULTIUNITI

Consistency0095 (G)

250~320 (Approved Limits),260~300 (Caution Limits)

Average (n = 3): 257

Comments:Individual testing on BIMIEsamples.Beginnin~V(OlsChilrgea~} Validation Batch (V-788PR'()}

\__ - . .'" ." . --'.

APpnovcr" E'! QUALITY_~~-s;,go 1.-Autnorlzed Signature Oat,

;:

1 Ve!leywood Drive, SUIte.1.oo; ~ion_at'lo'l3R 51..9Tel. (905) 470-2028 f~;-(905):47t:i-9241 alaCPL

Laboratory Services

Certificate of Analysis Page 1 of 1

Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/1612012

Material Number: 5003495TestingPOI: N/A

Specification Revision #: 1- ---

IP #: 78973

Tests Required: REDUCEDCOA Revision #:- -. 0

Product: Plastibase SOW (Finished Product) 1249084Batch#: 74589 Lot#: 74589TestStarted: 01/1212012 TestCompleted: 01/1212012

TESTIMETHOD SPECIFICATIONIUNIT I RESULTIUNIT

Consistency0095 (G)

250-320 (Approved Limits).260-300 (Caution Limits)

Average (n = 3): 259

Comments:Indivldual testing on ~ samples.Me. jDischarged2).Yalidatlon Batch (V-788PR-o)

1 Valleywood Drive, Slite 100, Markhan, Ontariol3R 5L9 Tel. (905) 470-2028 Fax. (905) 470-9241 ["':1CPL

L.aboratcry Services

Certificate of Analysis Page 1 of 1

Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/16/2012

Material Number: 5003495Testing PO#: NlA

Specification Revision #: 1

IP#: 78974Tests Required: REDUCEDCOA Revision.#: .0

Product: Plastibase 50W (Finished Product) 1249084Batch I: 74589 Lot#: 74589

Test Started: 01/1212012 Test Completed: 01/1212012

TEST/METHOD SPEC/FICA TlONlUNIT I RESULTIUNIT,Consistency0095 (G)

250-320 (ApprOVed Umits),260-300 (Caution Limits)

Average (n=3): 258

Comments:Individual testing on BIMIE samples}End.-(DI~~I1~rgiK!-=-?):Validation Batch (V-788PR·O)

\.--~-., ..

AP?i10VF..D l~':' QUf.\U1Y

--iJL~Jd I~/"-Authorlzed Signature/oiite