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PUBLIC

0001

File No. CT-2023-007

COMPETITION TRIBUNAL IN THE MATTER OF the Competition Act, R.S.C. 1985, c. C-34 (the “Act”); AND IN THE MATTER OF an application by Apotex Inc. for an order pursuant to section 103.1 of the Act granting leave to bring an application under section 79 of the Act;

AND IN THE MATTER OF an application by Apotex Inc. for an order pursuant to section 79 of the Act;

BETWEEN: APOTEX INC. Applicant and PALADIN LABS INC., ENDO PHARMACEUTICALS INC., TAKEDA CANADA INC., and TAKEDA PHARMACEUTICALS U.S.A. INC.

Respondents ______________________________________________________________________________ NOTICE OF APPLICATION FOR LEAVE (Pursuant to section 103.1 of the Competition Act) ______________________________________________________________________________

TAKE NOTICE THAT:

1.

The Applicant will make an application to the Competition Tribunal (“Tribunal”) on a date and time to be set by the Tribunal at Ottawa or Toronto, Ontario pursuant to section 103.1 of the Competition Act (the “Act”) seeking leave to bring an application for:

a.

an Order pursuant to section 79(1) of the Act prohibiting Respondents for a period of 10 years from engaging in (i) practices that hinder or delay the supply to the Applicant of ICLUSIG® (ponatinib) (“ICLUSIG”) or any other drug supplied by Respondents for which Respondents have received a Notice of Compliance under

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the Food and Drug Regulations and (ii) other practices that form the basis for the within Application;

2.

3.

4.

b.

c.

d.

e.

f.

g.

an Order pursuant to section 79(2) of the Act requiring Respondents, jointly and severally, to supply 360 tablets of 15 mg ICLUSIG to the Applicant, or such other volumes of ICLUSIG as the Applicant may reasonably request, within five business days of the Tribunal’s Order, at the same price applicable to other sales of ICLUSIG in Canada;

an Order pursuant to section 79(3.1) of the Act requiring Respondents, jointly and severally, to pay an administrative monetary penalty represented by the amount of revenue earned by Paladin Labs Inc. from the sale of ICLUSIG in Canada between September 22, 2023 and the date of the Order, multiplied by three, or such other amount as the Applicant may request and the Tribunal deems just;

an Order for interim relief, if the Applicant so requests;

an Order expediting the hearing of the within Application;

an Order for costs of the within Application; and

such further and other orders as the Applicant may request and the Tribunal deems just.

The persons against whom the orders are sought are the Respondents: Paladin Labs Inc., Endo Pharmaceuticals Inc., Takeda Canada Inc. and Takeda Pharmaceuticals U.S.A. Inc. Respondents’ addresses are set out below.

The Applicant will rely on the Statement of Grounds and Material Facts attached as Schedule “A” to the proposed Notice of Application; the Affidavit of Nick Boorman, sworn September 29, 2023; the Memorandum of Fact and Law accompanying this Application; and such further or other material as counsel may advise and the Tribunal may permit.

The Applicant requests that this Application be heard in the English language.

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5. The Applicant requests that the documents for this Application be filed in electronic form.

Dated at Toronto this 29th day of September, 2023. v \ .sov,c--() GOODMANS LLP 3400-199 Bay St Bay Adelaide Centre Toronto, ON M5H 2S7

Michael Koch Julie Rosenthal David Rosner Josh Zelikovitz

Tel: 416-979-2211 Fax:416-979-1234

mkoch@goodmans.ca jrosenthal@goodmans.ca drosner@goodmans.ca jzelikovitz@goodmans.ca

Lawyers for the Applicant

TO:

The Registrar Competition Tribunal 90 Sparks Street, Suite 600 Ottawa, ON K113 5B4 Tel: 613-957-7851 Fax: 613-952-1123

AND TO: Matthew Boswell Commissioner of Competition Competition Bureau 50 Victoria Street Gatineau, QC K1A 0C9 Tel: 819-997-4282

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AND TO:

AND TO:

AND TO:

AND TO:

Fax: 819-997-0324 Jean De Serres, Vice President Scientific Affairs Paladin Labs Inc. 100 Alexis-Nihon Blvd #600 Saint-Laurent, QC H4M 2P2 Phone: 514-340-1112 Fax: 514-344-4675

Matthew J. Maletta, Chief Legal Officer Endo Pharmaceuticals Inc. 1400 Atwater Dr Malvern, PA, , 19355 Phone: 484-216-0000 Fax: 800-329- 3636

Matthew Castellarin, Head of Legal, Canada Takeda Canada Inc. 3800-22 Adelaide St W Bay Adelaide Centre, East Tower Toronto, ON M5H 4E3 Phone: 866-397-4473

Yoshihiro Nakagawa, Global General Counsel Takeda Pharmaceuticals U.S.A. Inc. 95 Hayden Ave Lexington, MA 02421 Phone: 617-349-0200

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File No. CT-2023-007 COMPETITION TRIBUNAL IN THE MATTER OF the Competition Act, R.S.C. 1985, c. C-34 (the “Act”);

AND IN THE MATTER OF an application by Apotex Inc. for an order pursuant to section 103.1 of the Act granting leave to bring an application under section 79 of the Act;

AND IN THE MATTER OF an application by Apotex Inc. for an order pursuant to sections 79 of the Act;

BETWEEN:

APOTEX INC. and

Applicant

PALADIN LABS INC., ENDO PHARMACEUTICALS INC. TAKEDA CANADA INC. and TAKEDA PHARMACEUTICALS U.S.A. INC. Respondents _________________________________________________________

NOTICE OF APPLICATION FOR LEAVE (Pursuant to s. 103.1 of the Competition Act) _________________________________________________________

GOODMANS LLP 3400-199 Bay St Bay Adelaide Centre Toronto, ON M5H 2S7

Michael Koch (mkoch@goodmans.ca) Julie Rosenthal (jrosenthal@goodmans.ca) David Rosner (drosner@goodamns.ca) Josh Zelikovitz (jzelikovitz@goodmans.ca)

Tel: 416-979-2211 Lawyers for the Applicant

 You are being directed to the most recent version of the statute which may not be the version considered at the time of the judgment.