Market Exclusive

GUIDED THERAPEUTICS, INC. (OTCBB:GTHPD) Files An 8-K Entry into a Material Definitive Agreement

GUIDED THERAPEUTICS, INC. (OTCBB:GTHPD) Files An 8-K Entry into a Material Definitive Agreement

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, 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. 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 CPCs 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 Companys 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 Companys previous license to
Shenghuo. Under the terms of the new agreement, Shenghuo agreed
to relinquish its manufacturing license and its distribution
rights in SMIs 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 Companys 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 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 Registrants 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 Companys 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 Companys code of ethics.
Item 9.01
Financial Statements and Exhibits
(d)
Exhibits.
Number
Exhibit
10.1
Agreement, dated January 22, 2017, between the Company
and Shandong Yaohua Medical Instrument Corporation
10.2*
Agreement, dated January 22, 2017, between the Company
and Shenghuo Medical, LLC
99.1*
Press Release, dated January 25, 2017
*Previously filed as part of the current report on Form
8-K, filed January 26, 2017.
-3-

About GUIDED THERAPEUTICS, INC. (OTCBB:GTHPD)
Guided Therapeutics, Inc. is a medical technology company. The Company is focused on developing medical devices. The Company’s primary focus is the sales and marketing of its LuViva Advanced Cervical Scan non-invasive cervical cancer detection device and extension of its cancer detection technology into other cancers, including esophageal. The Company’s technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. The Company focuses on two primary applications for LuViva: first, as a cancer screening tool and second, as a triage. Its product, in addition to detecting the structural changes attributed to cervical cancer, is also detects the biochemical changes that precede the development of visual lesions. LuViva consists of three components: Touch screen monitor, Hand Held Unit (HHU) and the Wheeled Base. GUIDED THERAPEUTICS, INC. (OTCBB:GTHPD) Recent Trading Information
GUIDED THERAPEUTICS, INC. (OTCBB:GTHPD) closed its last trading session 00.0000 at 0.0000 with 54,019,175 shares trading hands.

Exit mobile version