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