Current Report Filing (8-k)
March 18 2019 - 10:41AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event
Reported): March 15, 2019
GW
PHARMACEUTICALS PLC
(Exact name of registrant as specified
in its charter)
England and Wales
(State or other jurisdiction
of incorporation)
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001-35892
(Commission
File Number)
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N/A
(I.R.S. Employer
Identification No.)
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Sovereign House, Vision Park Chivers
Way, Histon Cambridge, CB24 9BZ United Kingdom
(Address of Principal Executive Offices, including Zip Code)
Telephone: +44 1223 266 800
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former name or former
address,
if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
¨
If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 1.01.
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Entry into a Material Definitive Agreement.
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On March 15, 2019, GW Research Ltd., the principal research
subsidiary of GW Pharmaceuticals plc (the “Company”), entered into a definitive agreement to sell its Rare Pediatric
Disease Priority Review Voucher (“PRV”) for $105,000,000 to Biohaven Pharmaceutical Holding Ltd. (the “PRV Transfer
Agreement”). The Company was awarded the voucher under a U.S. Food and Drug Administration (“FDA”) program intended
to encourage the development of treatments for rare pediatric diseases. GW Research Ltd. received the PRV when EPIDIOLEX
®
(cannabidiol) was approved by the FDA for the treatment of seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome,
two rare, severe childhood-onset epilepsies.
The PRV Transfer Agreement contains customary representations,
warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary
closing conditions, including anti-trust review.
The foregoing summary of the material terms of the PRV Transfer
Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, a copy
of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019.
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Item 2.01
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Completion of Acquisition or Disposition of Assets.
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The disclosure regarding the PRV Transfer Agreement contained
Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.01.
On March 18, 2019, the Company issued a press release announcing
the sale of the PRV. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
by reference herein.
The information contained in Item 8.01 of this Form 8-K,
including Exhibit 99.1 furnished herewith, shall not be deemed “filed” for the purpose of Section 18 of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed
incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, whether made before
or after the date hereof, except as expressly set forth by specific reference in such a filing.
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Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
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Date: March 18, 2019
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GW PHARMACEUTICALS PLC
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By:
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/s/ Douglas B. Snyder
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Name: Douglas B. Snyder
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Title: Chief Legal Officer
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