Attached files
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| EX-10.1 - AGREEMENT, DATED JANUARY 22, 2017, BETWEEN THE COMPANY AND SHANDONG YAOHUA MEDIC - GUIDED THERAPEUTICS INC | gthp_ex101.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K/A
Amendment
No. 1
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): January 22,
2017
GUIDED THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-22179
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58-2029543
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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5835 Peachtree Corners East, Suite D
Norcross, Georgia
(Address
of principal executive offices)
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30092
(Zip
Code)
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Registrant’s
telephone number, including area code: (770) 242-8723
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:
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☐
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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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☐
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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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EXPLANATORY NOTE
Guided
Therapeutics, Inc. (the “Company”) hereby amends its
current report on Form 8-K filed with the U.S. Securities and
Exchange Commission (the “Commission”) on January 26,
2017 ( the “Current Report”). The Company had
previously submitted a request for confidential treatment to the
Commission concerning Exhibit 10.1 to the Current Report, which has
been withdrawn. An unredacted copy of the agreement is
included as Exhibit 10.1 hereto and the disclosure under Item 1.01
of this amendment reflects the unredacted information.
Other
than as expressly set forth above, this amendment does not, and
does not purport to, amend, restate, or update the information
contained in the Current Report, or reflect any events that have
occurred after the Current Report was filed. As a result, the
Current Report, as amended hereby, continues to speak as of the
initial filing date and time of the Current Report.
Item
1.01.
Entry
into a Material Definitive Agreement.
On
January 22, 2017, the Company entered into a license agreement with
Shandong Yaohua Medical Instrument Corporation, or SMI, pursuant to
which the Company granted SMI an exclusive global license to
manufacture the LuViva device and related disposables (subject to a
carve-out for manufacture in Turkey) and exclusive distribution
rights in the Peoples Republic of China, Macau, Hong Kong and
Taiwan. In exchange for the license, SMI will pay a $1.0 million
licensing fee, payable in five installments through October 2017,
underwrite the cost of securing approval of LuViva with the Chinese
Food and Drug Administration, or CFDA, and, once it obtains CFDA
approval, pay $1.90 royalty on each disposable sold in the
territories by purchasing directly from the Company a Controlled
Programmable Chip (CPC), necessary for the operation of disposable
unit. Pursuant to the SMI agreement, SMI must become capable of
manufacturing LuViva in accordance with ISO 13485 for medical
devices by the second anniversary of the SMI agreement, and achieve
CFDA approval by July 22, 2019, or else forfeit the license. During
2017, SMI must purchase no fewer than ten devices at $13,000 each
(with up to four devices pushed to 2018 if there is a delay in
obtaining approval from the CFDA). In the three full calendar years
following CFDA approval, SMI must sell a minimum of 3,500 devices
(500 in the first year, 1,000 in the second, and 2,000 in the
third), and purchase a minimum of 25,200,000 CPC’s from the
Company, resulting in revenues of $47,880,000 to the Company over
the three-year period, or else forfeit the license. As manufacturer
of the devices and disposables, SMI will be obligated to sell each
to the Company at costs no higher than the Company’s current
costs. As partial consideration for, and as a condition to, the
license, and to further align the strategic interests of the
parties, the Company agreed to issue $1.0 million in shares of its
common stock to SMI, in five installments through October 2017, at
a price per share equal to the lesser of the average closing price
for the five days prior to issuance and $1.25.
In
order to facilitate the SMI agreement, immediately prior to its
execution the Company entered into an agreement with Shenghuo
Medical, LLC, regarding the Company’s previous license to
Shenghuo. Under the terms of the new agreement, Shenghuo agreed to
relinquish its manufacturing license and its distribution rights in
SMI’s territories, and to waive its rights under the original
Shenghuo agreement, all for as long as SMI performs under the SMI
agreement. As consideration, the Company has agreed to split with
Shenghuo the licensing fees and net royalties from SMI that we the
Company receive under the SMI agreement. Should the SMI agreement
be terminated, the Company has agreed to re-issue the original
license to Shenghuo under the original terms. The Company’s
COO and director, Mark Faupel, is a shareholder of Shenghuo, and
another director, Richard Blumberg, is a managing member of
Shenghuo.
The
above descriptions are qualified in their entirety by reference to
the SMI agreement and the Shenghuo agreement, attached as Exhibits
10.1 and 10.2, respectively, to this current report and
incorporated herein by reference. A press release further
describing the agreements is attached at Exhibit 99.1 and is
incorporated herein by reference.
This
current report on Form 8-K is neither an offer to sell nor the
solicitation of an offer to buy any securities. The securities
described above have not been registered under the Securities Act
and may not be offered or sold in the United States absent
registration or an exemption from registration under the Securities
Act.
Item
3.02
Unregistered
Sales of Equity Securities
The
information set forth under Item 1.01 is incorporated by reference
into this Item 3.02. The issuance of the securities described under
Item 1.01 pursuant to the SMI agreement has been conducted as a
private placement to “accredited investors” (as that
term is defined under Rule 501 of Regulation D), and is exempt from
registration under the Securities Act of 1933 in reliance upon
Section 4(a)(2) of the Securities Act, as a transaction by an
issuer not involving a public offering.
Item
5.05
Amendments
to the Registrant’s Code of Ethics, or Waiver of a Provision
of the Code of Ethics.
The
information set forth under Item 1.01 is incorporated by reference
into this Item 5.05. On January 15, 2017, each of the disinterested
directors on the Company’s Board of Directors, having
considered the interests of Dr. Faupel and Mr. Blumberg and having
approved the agreement, effectively waived the conflict-of-interest
provisions of the Company’s code of ethics.
Item
9.01
Financial
Statements and Exhibits
(d)
Exhibits.
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Number
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Exhibit
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Agreement,
dated January 22, 2017, between the Company and Shandong Yaohua
Medical Instrument Corporation
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10.2*
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Agreement,
dated January 22, 2017, between the Company and Shenghuo Medical,
LLC
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99.1*
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Press
Release, dated January 25, 2017
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*Previously
filed as part of the current report on Form 8-K, filed January 26,
2017.
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-3-
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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GUIDED
THERAPEUTICS, INC.
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/s/
Gene S. Cartwright, Ph.D.
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By: Gene
S. Cartwright, Ph.D.
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President and Chief
Executive Officer
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Date: March
24, 2017
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-4-
EXHIBIT
INDEX
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Number
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Exhibit
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Agreement,
dated January 22, 2017, between the Company and Shandong Yaohua
Medical Instrument Corporation
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10.2*
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Agreement,
dated January 22, 2017, between the Company and Shenghuo Medical,
LLC
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99.1*
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Press
Release, dated January 25, 2017
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*Previously
filed as part of the current report on Form 8-K, filed January 26,
2017.
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