+I+ Bristol-Myers Squibb CompanyQuality Operations External Manufacturing

One Squibb Drive P.O. Box 191 New Brunswick, NJ 08903-0191732 227-5000

22 February 2012

GMP COMPLIANCE DECLARATION

To whom it may concern

I, the undersigned, Judith Steinbach, Manager, Bristol-Myers Squibb Quality

Operations External Manufacturing, North America declare that the product, Plastibase,

manufactured at Contract Pharmaceuticals Limited in Mississauga, Canada, is

manufactured under a validated process in compliance with the current Good

Manufacturing Practices.

Manager, Quality Operations External Manufacturing, North America

Bristol-Myers Squibb Company

I HealthCanada

SanteCanada

Health Products and FoodBranch Inspectorate

Licence Number

100022-ANumero de la licence

Inspectorat de la Direction generaledes produits de sante et des aliments

Establishment Licence Licence d'etablissement

CONTRACT PHARMACEUTICALS LTO. CANADA

7600 DANBRO CRESCENT

MISSISSAUGA, ON,CANADA, L5N 6L6

This licence is issued in accordance witll the Food and Drugs Act &Regulations (Division 1A & 2) (or the following activities andcategories of drugs:

Cette licence est delivree coniormemen: a /a Loi et aux Reglementssur les aliments et drogues (tllres 1A et 2) pour tes activites et /es

categories de drogues suivantes:

CATEGORYI Pharmaceufieal Vaccines Blood 3 Schedule D " Schedule C 5 6

ACTIVITYI Categorie Prod. phannaoeutique Vaccins Sang L'annexe 0 L'annexe C

Activite

Fabricate XManufacturer

Package I label XEmballer-etiqueter

Test1 XAnalyser

DistributiDistribuer

ImportImporter

WholesaleVendre en gros

(1) PenOfm :he tests. indueling any exam/nations rcquir(Xj undor Division 21 Analyser cOllformemenl au /j/re 2

(2) Distribute as set out in paragraph C.01.A.OO3(a) andiOf (b) / lY.slribuer a We de dislribuer au sens de faIinea C.01A.OO3 fa} oVou M(3) Whote blood and ~s components 1Sang enlier c/ ses composatt(s(4) Orvgs listed In Schedule D to tM Acl, o:her than vaccines or whete blood and its components / Drogue visee " ranne.e 0 de /a La.; au/te qU'UII veccln 0<1qv" Ie sang enlier 01ses composants

(5) Orvgs tisted in Schedulo C to the Acll Drogue visee a I'annexe C de /a Loi

(6) Drugs tisted in the Scheclule to Part G of the Food and Drug Regulations, drugs ~sted in Schedule F to the Food and Drug Rogulations, narcotics as defined In seciion 2 0( tho Nmcotic ContrOl RegulatiOns IDrogue visl!e a l'a1l1leJCe dll Pattie G oes Reglements sur Jes abi1lenls cl drogues, drogue visee a I"anoexe FeJes Reg/ements sur les a.lmllnts el drogues. Slup6liants a<l sens de l'atticJe 2 des Reglemenl. sur les slu

(7) S relers to sterile dO$age 10'11l$/ S fait reference aux fOfmes posologiques s!erites

This licence is subject to the additional conditions as indicated intile attached:

Cette licence est assujeltie eux conditions supplementairesindiquees dans Ie feuil/et ci-joint:

Issued On / Emise Ie: 2010-07 -22 ILast Inspection Date / Date de la tieniere inspection: 2009-08-11CountOlsigned; Director General, Health Products and Food Brail<:h Inspeotorate 0( delegated authorityContresign. 6 PM: 70§2:~=.gOI ~ orat de la Oirodio~ 9f'era!o des produits de sante e\ des aliments ou aUlOfitoo deleSU"e_ ='~=-___ frf Dlrect~r .

Stephanie Reid COI~pha~ceC~~rdmatlon AUG 0 6 2010& L1censmg DIVision

MINISTER OF HEALTH

MINISTRE DE LA SANTE

This lice~ is \he property of the Health Products and Food Branch Inspectorato and must be returrn!d upon demand.

cene licence ~ppattient a rin$pectorat do Ia Dir<K:tion generale des proauits de santo lit des alimenlS et doit efl' t.re.re;;;t••ouriiine.·liie.'iiiur••d",eman~iiidiiie_IJ!II'I"""'t:te!":"':~~::=:~~"'flHoolth Produl;ts and Food Ifl.!lpOO\ora1dO 13Oitt"Ctlon genorateBranch Inspcctorato des produiU Cfcsanto ei d6S.aliments

Canada 2011Canada

Page

Health Products and Food Inspectorat de la Direction generaleBranch Inspectorate des produits de sante et des aliments

Licence Number

100022-CNumero de Is licence'

1+1 Health SanteCanada Canada

Establishment Licence

CONTRACT PHARMACEUTICALS LTD. CANADA

Licence d'etablissement

1 VALLEYWOODDRIVE, • UNIT 100MARKHAM, ON, CANADA, L3R 5L9

This licence Is issued in accordance with the Food and brugs Act &Regulations (Division 1A & 2) for tha following actiVIties andcategories of drugs:

Celtelicence est delivree conform{Jment Ii la Loi et aux R{Jglamentssur tes aliments at drogues (titres 1A et 2) pour tes activitas et Jes

catBgories de drogues suiventes:

''': ...~-

ACTlVITYIActivit.

CATEGORY I PharmaceuticalCat6gorle Prod.. pillI1TI8QtUtiqUfJ

(S • StINlltJ) 7

Blood 3Sang

ScheduleD 4L'annenO

ScheduleC 5L~eC

6

FabricateManufacturer

'" :.. ." .:-~~,- -"'--:: ::,;'-;~·~L~i~

Package I fabelEmball"'~etw

" "~--~~~:":-;'".~' ..

s..

-_"'. _4_.~ _~

ImportImpotter

. ., .. .(1) Plltform the teat_, inclldno any examination. requited t.nder Division 21Ma/y_ confrlrrMment au titre 2

(2) Distribute •• aet out in pangraph C.01AOO3 (a) and/or (b) I Di$l1ibuer. titre de distribuer ItU3efJ$de "a6n6a C.OIA.OO3 (a) eIIou (b)(3) Whol. blood and ita componenta I S8"11 en6rtr et ••••• compo$Eln/a

(4) 0nJgs ijsted in Sdledule D to the Act. _than vlKlCinea or whole bloOd and its components I D/IlIIue IrisoIeII'annex8 D de fa Loi, autre qu'un vacdn au que 1&$4Ing en/ier at ses romposants

(5) Drugs ~atad In ScIledule C to the ActIDI'OQUIt IrisoIelranllllXlt C de/a I..DI(6) Drugs fiatad in the Schedule to Part G of the Food and Drug Regulation.. dtugs IIsta" in Schedule F lo'the Food and Drug Regulations. IlIWCOtice8S deflned rn I8C1ico 2 of the Narcotic Control Regulatlons'Drogue IIi$Ila It fanne •• de _ G des RIlgIemSn" sur 1&5afm&nIs at dlOQlJll" drogue vis&e I rannex. F des Reglamen/a sur "'" aDments et dmglJ8S. stupMisn1s au sans de r.t1JcIe 2 des RBgiemen1s sur /83 stu(7) S refers 10 atariI. dolage fotmS I S fait ~enca awe fOf11ln posologiques s!oIrile.

. ~- -...~

This licence is subject to the additional conditions as indicated inths attached:

Celts licence est BSsuje/tie aux conditions supplementairesindiqueas dans 18 feuillet cijoint:

Issued On / Emise Ie: 2010-12-08

MINISTER OF HEAlTH

Last Inspection Date / Date de la deniere inspect/on: 2009-12-01COU"iIersIgned: DIrecIor General. Health Products and Food Branch InopecioratB or delegated authority . n r=-,..Contretlgn6 par. Oiractaur g9n6n0I, InopeclDrat de Ia Direction gWraia de. pmduitI de sant8 et du aliments au ~ •• de~ • IJ 2 0 2010

DIrectorCompil<!nce Coordination. . . .Basanti GhoshMINISTRE DE LA SANTE

TIlls licence Is the property of the Health ProducII and Food Branch Inspectorate and mUll be retunad upon dellla1d.Cett.1i<:ence appartient il'lnspactonrt de Ie Dinrcllon g6n8raIe dosprodubde sarrte at des aliments et dei! 6tre retoum6e surdamander!'~~IIIi!I'I~~_~_~~I!!II"_~"

=,=,"",'::'- . !J.~~::'.sl J Ji. .

Canada '·201:1:&.;::._• .:.:.......::==.:;.,. .:'=':.:' =- ,~.Canada.;:::. ::::',=_ . __

Page

~:~ Bristol-Myers Squibb CompanyGlobal Regulatory Sciences - Chemistry, Manufacturing and Controls

P.O. Box 5400, Princeton, NJ 08543-5400

609-818-3000

07 February 2012

To Whom It May Concern:

Subject: Statement on the Transmissible Spongiform Encephalopathies (TSE) status ofPlastibase manufactured by Contract Pharmaceuticals Limited (CPL) for Bristol-Myers SquibbCompany

The Bristol-Myers Squibb Company (BMS) hereby certifies that Plastibase manufactured atCPL in Mississauga, Ontario, Canada for Bristol-Myers Squibb Company meet the criteria foracceptability based upon an evaluation of TSE risk conducted in accordance with the BMSCorporate Policy and Program for the Assessment of Risk of Transmissible SpongiformEncephalopathies Arising From the Use of Animal-Derived Materials.

BMS evaluated all the raw materials used in the manufacture of Plastibase. All excipients usedin the manufacture ofPlastibase, manufactured by CPL, were also evaluated.

• All raw materials used in the manufacture of Plastibase are non animal-derivedmaterials

Susan ManneAssociate Manager, Regulatory & Compliance - IPRITSEResearch & Development - GRS-CMCBristol-Myers Squibb Company

Michael J. Munster. Ph.D.Director. Quality Operations. External ManufacturingWolldwide Quality & ComplianceTechnical Operations

f~~Bristol-Myers Squibb Company One Squibb Drive New Brunswick. NJ OBB03·0191

Tel (732) 227-7564 Fax (732) 227·3924

rnichael.ll1llllster3bll1s.cOJll

February 7, 2012

Subject: Plastibase"

Dear Customer:

Please note that neither the ingredients nor the manufacturing process of Plastibase" (Polyethylene - Mineral

Oil Gel Base) contain or introduce any of the solvents referenced as Class 1,2, and 3 as described in the current

USP34 chapter <467> Residual Solvents.

According, Plastibase" (Polyethylene - Mineral Oil Gel Base) is not tested for residual solvents and is in

alignment with the requirements with the current USP34 chapter <467> Residual Solvents.

North American Free Trade Agreement

CERTIFICATE OF ORIGIN• Exporter's Name and Address:

Contract Pharmaceuticals Limited7600 Danbro Cres.Mississauga, ON L5N••..6,;:..L....;6'-- ---=-I

Tax identification No: 123057713RMOOOlr-Producer's Name and Address:

. Contract Pharmaceuticals Limited7600 Danbro Cres.Mississauga, ON L5N 6L6

Tax IdentlHution No: 12J057713RMO(IOl

Description of Good(s):

IIBlanket Period:

From: 01/01/12 To: 12/31112

ImpOrter's Name and Address:

Bristol Myers Squibb777 Scudders Mill RoadPlainsboro, NJ 08536

Country

Classification Preference Net of

Number Criterion Producer Cost Origin

2710.19 B YES NO CanadaPlastibase, Bulk

I Certify That:The information on this document is true and accurate and I assume the responsibility for proving such representations, I understand that I am liable

for any false statements or material omissions made on or in connection with this document;

I agree to maintain and present upon request documentation necessary to support this certificate, and to inform, in writing, all persons to whom the certificate

was given of any changes that could affect the accuracy or validity of this certificate;

- The goods originated in the territory of one or more of the Parties, and comply with the origin requirements specified for those goods in the North

American Free Trade Agreement, and unless specifically exempted in Article 411 or Annex 401, there has been no further production or any other

operation outside the territories of the Parties, and

• This certificate consists of _,_ pages, including all attachments.

Company:Contract Pharmaceuticals Limited

Kathleen Smith

905-821-7600Date: 01/01/2012

Title:Traffic Co-ordinator

Fax: 905-821-7601CU6lOmS. excise and taxation