Current Report Filing (8-k)
April 03 2019 - 7:33AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): April 1, 2019
CytoDyn Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-49908
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83-1887078
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(State or other jurisdiction
of incorporation)
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(SEC
File Number)
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(I.R.S. Employer
Identification No.)
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1111 Main Street, Suite 660
Vancouver, Washington
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98660
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (360)
980-8524
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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☐
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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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☐
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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. ☐
Item 1.01.
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Entry into a Material Definitive Agreement
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On April 1, 2019, CytoDyn Inc., a Delaware corporation (the Company), entered into a Master Services Agreement and Product Specific Agreement
(together, the Agreement) with Samsung BioLogics Co., Ltd. (Samsung), pursuant to which Samsung will perform technology transfer, process validation, manufacturing and supply services for the commercial supply of the
Companys leronlimab (PRO140) drug substance (Product).
Under the terms of the Agreement, the Company is obligated to make specified
minimum purchases of Product from Samsung pursuant to the Companys forecasted requirements. The first forecast for Product will be delivered to Samsung by March 31, 2020. The Company must provide Samsung with a rolling forecast on a
quarterly basis setting forth the total quantity of Product that it expects to require in the following years. The Company estimates that initial
ramp-up
costs to manufacture commercial Product at scale could
aggregate approximately $60 million, with approximately $30 million payable over the course of calendar 2020 and approximately $30 million more payable in the first quarter of 2021. Thereafter, the Company will pay Samsung per 15,000L
batch according to the pricing terms specified in the Agreement.
The Companys agreement with Samsung has an initial term ending in December 2027
and shall be automatically extended for additional two year periods unless either party gives notice of termination at least six months prior to the then current term. Either party may terminate the Agreement in the event of the other partys
insolvency or uncured material breach, and the Company may terminate the Agreement in the event of a voluntary or involuntary complete market withdrawal of Product, with one and half years prior notice. Neither party may assign the Agreement
without the consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the Agreement relates. The Agreement contains indemnification and limitation of liability provisions.
A copy of the Agreement will be filed as an exhibit in an amendment to this Current Report on Form
8-K
or in our next
annual report due to be filed under the Securities Exchange Act of 1934.
Item 7.01.
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Regulation FD Disclosure
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On April 2, 2019, the Company issued a press release relating to the announcements described in Item 1.01 above, a copy of which is furnished as
Exhibit 99.1 to this
Form 8-K.
Item 9.01.
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Financial Statements and Exhibits.
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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
hereunto duly authorized.
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CytoDyn Inc.
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April 3, 2019
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By:
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/s/ Michael D. Mulholland
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Name:
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Michael D. Mulholland
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Title:
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Chief Financial Officer
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