Voluntary Compliance Undertaking of GlaxoSmithKline Inc. to the Patented Medicine Prices Review Board

1.0 Background

1.1 GlaxoSmithKline Inc. ("GSK") has, sua sponte, conducted a comprehensive and extensive audit of its patent portfolio to determine compliance with sections 79 to 103 of the Patent Act, the Patented Medicines Regulations made thereunder and the Compendium of Policies, Guidelines and Procedures of the Patented Medicine Prices Review Board (the "Guidelines" and the "PMPRB", respectively).

1.2 The results of GSK's voluntary audit have disclosed a number of instances of inadvertent non-compliance in reporting and pricing, including in respect of some products which have been discontinued or are otherwise not actively marketed. These instances of inadvertent non-compliance include drug products that have never been reported to the PMPRB and drug products that, while once-reported, ceased to be reported to the PMPRB.

1.3 The reporting non-compliance has been rectified to the satisfaction of the PMPRB. The purpose of this Voluntary Compliance Undertaking ("VCU") is to remedy the pricing non-compliance to the satisfaction of the PMPRB.

2.0 Affected Products

2.1 The products in respect of which filing non-compliance was found, identified by brand and drug identification number, are set out on Schedule "A" attached hereto (individually, a "Product" and, collectively, the "Products").

2.2 GSK is the patentee of the Products as that term is defined in subsection 79(1) of the Patent Act and for purposes of the PMPRB.

3.0 Position of Patentee

3.1 This VCU constitutes no admission by GSK that the prices of the Products are or were excessive for purposes of the Patent Act.

4.0 Terms of the Voluntary Compliance Undertaking

4.1 In order to comply with the Guidelines to the satisfaction of the PMPRB, GSK undertakes as follows:

4.1.1 to offset cumulative excess revenues received by GSK in respect of the Products as of December 31, 2016, by making a payment to Her Majesty the Queen in right of Canada in the amount of $31,000,000.00 within 90 days of the notification of the acceptance of this VCU.

4.1.2 to agree that the 2017 N-NEAPs for the Products that continued to be sold in 2016 are as set out on Schedule"B";

4.1.3 subject to subsection 4.1.4, to reduce the N-ATPs of the Products in 2017 to the 2017 N-NEAPs referred to in subsection 4.1.2 and set out on Schedule "B";

4.1.4 to the degree that GSK is unable to comply with subsection 4.1.3 in respect of any given Product due to the existence of reasonable timing and volume constraints,to offset any additional excess revenues received by GSK in respect of the Products from January 1, 2017 to December 31,2017, as calculated by PMPRB Staff, within 30 days of the filing of the July to December 2017 price and sales data; and

4.1.5 to ensure that the price of any given Product remains within the Guidelines in all future periods in which such given Product is under the PMPRB's jurisdiction.

GlaxoSmithKline Inc.

Name: Paul Lirette

Position: President Canada

Date: February 8, 2017

Schedule A to
Voluntary Compliance Undertaking
Product List
DIN Brand Name
02192691 3TC 10 MG/ML
02192683 3TC 150 MG
02247825 3TC 300 MG
02240835 ADVAIR DISKUS 50/100
02240836 ADVAIR DISKUS 50/250
02240837 ADVAIR DISKUS 50/500
02245126 ADVAIR HFA 25/125
02245127 ADVAIR HFA 25/250
02336650 AREPANRIX HlNl
02401886 AREPANRIX H5Nl
02298589 AVAMYS
02248440 AVANDAMET 2/1000
02247086 AVANDAMET 2/500
02248441 AVANOAMET 4/1000
02247087 AVANDAMET 4/500
02241112 AVANDIA 2 MG
02241113 AVANDIA 4 MG
02241114 AVANDIA 8 MG
02370050 BENLYSTA 120 MG
02370069 BENLYSTA 400 MG
00370568 BENOXYL LOTION 10%
00187585 BENOXYL LOTION 20%
02247600 BOOSTRIX
02312557 BOOSTRIX POLIO
02408872 BREO ELLIPTA 100/25
02212277 CEFTIN TABLETS 250 MG
02212285 CEFTIN TABLETS 500 MG
02299844 CELSENTRI 150 MG
02299852 CELSENTRI 300 MG
02342227 CERVARIX
02242970 CLINDASOL
02243050 CLINDETS
02382822 CLINDOXYL ADV GEL
02243158 CLINDOXYL GEL
00068756 COACTIFED EXPECTORANT SYRUP
00068594 COACTIFED SYRUP
00068608 COACTIFED TABLETS
02239213 COMBIVIR
02025736 CORTISPORIN EVE/EAR SUSPENSION
01912828 CORTISPORIN LIQUID OTIC SOLUTION
00666246 CORTISPORIN OINTMENT
02089912 CUTIVATE CREAM
02192284 CYCLOCORT CREAM
02192276 CYCLOCORT LOTION
02192268 CYCLOCORT OINTMENT
00192597 EMO CORT CREAM 1%
00595799 EMO CORT CREAM 2.5%
00192600 EMO CORT LOTION 1%
00595802 EMO CORT LOTION 2.5%
00641154 EMO CORT SOLUTION 2.5%
00666130 EMPRACET-30
01919431 ENGERIX-B
02296454 ENGERIX-B PEDIATRIC
02034506 ERYSOL
02213672 FLONASE
02237245 FLOVENT DISKUS 100 MCG
02237246 FLOVENT DISKUS 250 MCG
02237247 FLOVENT DISKUS 500 MCG
02237244 FLOVENT DISKUS 5O MCG
02244292 FLOVENT HFA 125 MCG
02244293 FLOVENT HFA 250 MCG
02244291 FLOVENT HFA 5O MCG
01914510 FLUVIRAL
02015986 FLUVIRAL
02420686 FLUVIRAL
02187078 HAVRIX 1440
02231056 HAVRIX 720 JUNIOR
02239193 HEPTOVIR 100 MG
02239194 HEPTOVIR 5 MG/ML
02239200 HIBERIX
02253852 INFANRIX HEXA
02257122 INFANRIX IPV/HIB
02241284 INFANRIX-IPV
02337258 INFLUENZA A HlNl
02269341 KIVEXA
02366924 LUXIQ
00587826 NERISONE CREAM
00587818 NERISONE OILY CREAM
00587834 NERISONE OINTMENT
02344408 OLUX-E
00527661 PANOXYL BAR 10%
00263699 PANOXYL GEL 10%
00373036 PANOXYL GEL 20%
02027887 PAXIL 10 MG
01940481 PAXIL 20 MG
01940473 PAXIL 30 MG
02248503 PAXIL CR 12.5 MG
02248504 PAXIL CR 25 MG
00804S41 PREVEX B
00804S33 PREVEX HC
02239208 PRIORIX
02297884 PRIORIX TETRA
02232S6S REQUIP 0.25 MG
02232567 REQUIP 1 MG
02232568 REQUIP 2 MG
02232569 REQUIP 5 MG
02238348 RESCRIPTOR
02008688 RETISOL-A 0.01%
02008718 RETISOL-A 0.05%
02008696 RETISOL-A 0.25%
02008726 RETISOL-A FORTE 0.1%
01902660 RETROVIR TABLETS 100 MG
01902644 RETROVIR IV 10 MG/ML
019026S2 RETROVIR SYRUP 10 MG/ML
02300591 ROTARIX
02214261 SEREVENT DISKHALER 5O MCG
02231129 SEREVENT DISKUS 5O MCG
02019825 SOLUGEL
02247228 STIEPROX SHAMPOO
00657204 STIEVA-A CREAM 0.01%
00578576 STIEVA-A CREAM 0.025%
00518182 STIEVA-A CREAM 0.05%
00662348 STIEVA-A CREAM 0.1%
00587966 STIEVA-A GEL 0.025%
00641863 STIEVA-A GEL 0.05%
00578568 STIEVA-A SOLUTION 0.03%
01945262 STIEVAMYCIN FORTE
02015994 STIEVAMYCIN MILO
01905112 STIEVAMYCINREGULAR
02320541 SYNFLORIX
02430932 TRIUMEQ
02244757 TRIZIVIR
02230578 TWINRIX
02237548 TWINRIX JUNIOR
02242727 TYPHERIX
00503134 UREMOL HC CREAM 1%/10%
00560022 UREMOL HC LOTION 1%/10%
02241047 VARILRIX
02213443 VENTOLIN IM INJECTION
02213451 VENTOLIN IV INFUSION
02213400 VENTOLIN NEBULES 1.25 MG
02022125 VENTOLIN NEBULES l.25 MG
02213419 VENTOLIN NEBULES 2.5 MG
01945203 VENTOLIN NEBULES 5 MG
02213427 VENTOLIN NEBULES 5 MG
02212390 VENTOLIN ORAL LIQUID
02213486 VENTOLIN RESPIRATOR SOLUTION
02348489 VERDESO
02240358 ZIAGEN 20 MG/ML
02240357 ZIAGEN 300 MG
02213567 ZOFRAN TABLET 4 MG
02213575 ZOFRAN TABLET 8 MG
02213745 ZOFRAN INJECTION
02229639 ZOFRAN ORAL SOLUTION
00634506 ZOVIRAX TABLET
00886157 ZOVIRAX SUSPENSION
Schedule B to Voluntary Compliance Undertaking

2017 NEAPs for drug products with 2016 sales that had never been reported to the PMPRB and drug product that while one-reported ceased to be reported.
DIN Brand Name 2017 N-NEAP
02312557 BOOSTRIX POLIO $10.5296
02212277 CEFTIN TABLETS 250 MG $1.3323
02212285 CEFTIN TABLETS 500 MG $2.1496
02243050 CLINDETS $0.S635
00068594 COACTIFED SYRUP $0.0713
02192284 CYCLOCORT CREAM $0.2S30
02192276 CYCLOCORT LOTION $0.2635
02192268 CYCLOCORT OINTMENT $0.2530
00192597 EMO CORT CREAM 1% $0.1448
00595799 EMO CORT CREAM 2.5% $0.2104
00192600 EMO CORT LOTION 1% $0.1469
00595802 EMO CORT LOTION 2.5% $0.2134
02213672 FLONASE $0.1979
02420686 FLUVIRAL $6.3765
02239200 HIBERIX $20.5791
02241284 INFANR IX-IPV $15.7758
00587818 NERISONE OILY CREAM $0.3107
00804541 PREVEX B $0.2106
00804533 PREVEX HC $0.1571
02232565 REQUIP 0.25 MG $0.2249
02232567 REQUIP 1MG $0.6386
02232568 REQUIP 2 MG $0.9770
02232569 REQUIP 5 MG $1.5817
02247228 STIEPROX SHAMPOO $0.1010
00657204 STIEVA-A CREAM 0.01% $0.3069
00578576 STIEVA-A CREAM 0.025% $0.3050
00518182 STIEVA-A CREAM 0.05% $0.2143
02242727 TYPHERIX $21.0601
02241047 VARILRIX $32.4826
02213451 VENTOLIN IV INFUSION $0.9330
02213419 VENTOLIN NEBULES 2.5 MG $0.2336
02213427 VENTOLIN NEBULES 5 MG $0.2716
02213486 VENTOLIN RESPIRATOR SOLUTION $0.2393
00886157 ZOVIRAX SUSPENSION $0.2236
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