Item 8.01 Other Events.
U.S. Antitrust Review
On June 24, 2020, uniQure biopharma BV ("uniQure biopharma"), a wholly owned
subsidiary of uniQure N.V. (the "Company"), entered into a commercialization and
license agreement (the "Agreement") with CSL Behring LLC ("CSL Behring")
providing CSL Behring exclusive global rights to etranacogene dezaparvovec, the
Company's investigational gene therapy for patients with hemophilia B (the
"Transaction"). The effectiveness of the Transaction is contingent on completion
of review under antitrust laws in the United States, Australia, and the United
Kingdom.
On December 3, 2020, uniQure biopharma and CSL Behring filed a Premerger
Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976 (the "HSR Act"). On January 4, 2021, the United States Federal Trade
Commission ("FTC") issued to uniQure biopharma a Request for Additional
Information and Documentary Material (a "Second Request") under the HSR Act. The
FTC similarly issued a Second Request to CSL Behring also with respect to the
antitrust review of the Agreement. Issuance of a Second Request is a standard
part of the regulatory approval process for transactions of this type. The
effect of the Second Requests is to extend the waiting period imposed under the
HSR Act until 30 days after all parties to the Agreement have substantially
complied with the requests, unless the waiting period is terminated earlier by
the FTC or voluntarily extended by the parties. The Company does not believe
that the consummation of the Transaction will result in a violation of any
applicable U.S. antitrust laws. However, there can be no assurance that a
challenge to the Transaction on antitrust grounds will not be made, or if such a
challenge is made, what the result would be. The Company expects the parties to
comply with the Second Requests and close the Transaction before the end of the
second quarter of 2021.
Other Antitrust Reviews
On November 24, 2020, the Competition and Markets Authority in the United
Kingdom (the "CMA") adopted a decision not to refer the Agreement for
proceedings under section 33 of the Enterprise Act 2002. The decision was made
public by the CMA on January 6, 2021. Thus, the CMA has completed its review of
the Agreement and the transactions contemplated by the Agreement may close from
the perspective of the United Kingdom competition authority.
On November 11, 2020, the Australian Competition and Consumer Commission
("ACCC") determined, pursuant to section 50 of the Competition and Consumer Act
2010, that it will not intervene in the Agreement. Thus, the ACCC has completed
its review of the Agreement and the transactions contemplated by the Agreement
may close from the perspective of the Australian competition authority.
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Forward-Looking Statements
This communication contains forward-looking statements. All statements other
than statements of historical fact are forward-looking statements, which are
often indicated by terms such as "anticipate," "believe," "could," "estimate,"
"expect," "goal," "intend," "look forward to", "may," "plan," "potential,"
"predict," "project," "should," "will," "would" and similar expressions.
Forward-looking statements are based on management's beliefs and assumptions and
on information available to management only as of the date hereof. These
forward-looking statements include, but are not limited to, whether the
Transaction will result in a violation of applicable antitrust laws, the timing
of the Company's compliance with the second request, and the Company's
expectation as to when it will close the Transaction. The Company's actual
results could differ materially from those anticipated in these forward-looking
statements for many reasons, including the risks, uncertainties and other
factors described under the heading "Risk Factors" in the Company's Report on
Form 10-Q filed on October 27, 2020. Given these risks, uncertainties and other
factors, you should not place undue reliance on these forward-looking
statements, and the Company assumes no obligation to update these
forward-looking statements, even if new information becomes available in the
future.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibits are being filed herewith:
104 Cover Page formatted in Inline XBRL.
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