Miraculins Executes Term Sheet to Appoint Cachet Pharmaceutical as
Exclusive Distributor of the Scout DS(R) Diabetes Test in China
Final Agreement to Include Upfront/Milestone Payments, a $15
Million USD First Order, and Projected Minimum Orders Valued at $75
Million USD over course of 5-Year Term
WINNIPEG, MANITOBA--(Marketwired - Jan 31, 2014) - Miraculins
Inc. (TSX-VENTURE:MOM), ("Miraculins" or the "Company") a medical
diagnostic company focused on acquiring, developing and
commercializing diagnostic and risk assessment technologies for
unmet clinical needs, today announces that it has executed a term
sheet ("Term Sheet") with Cachet Pharmaceutical Co., Ltd.
("Cachet") to appoint Cachet as the exclusive Chinese distributor
for the Scout DS® Non-Invasive Diabetes Screening Test.
The Scout DS® is the world's first non-invasive and
highly-sensitive test designed to measure diabetes related
biomarkers in the skin. It does not require a blood draw or fasting
and generates a result in as little as 80 seconds. The Scout DS®
uses visible light to measure the optical signature of fluorescent
biomarkers in the skin, the accumulation of which are accelerated
by abnormal blood sugar levels and oxidative stress.
The Term Sheet has now established the principal terms and
conditions of the proposed distribution agreement (the "Agreement")
between Miraculins and Cachet for China, including Scout DS® device
unit pricing, upfront and milestone payments, product ordering and
diligence requirements, and ongoing responsibilities of the
parties. Specifically, the Term Sheet provides that Miraculins
would receive up to $500,000 USD in upfront and milestone payments,
staged between signing the Agreement and the successful conclusion
of the China Food and Drug Administration ("CFDA") regulatory
clearance process. In addition, Cachet would place a first order
for Scout DS® devices valued at $15 million USD on signing of the
Agreement, which would be supported by the issuance of a proper
banking guarantee and activated upon CFDA regulatory clearance.
The term of the Agreement would extend for five years from the
date of CFDA clearance, subject to minimum annual order quantities
by Cachet. If minimum orders were met, this would represent an
additional order value of $75 million USD in Scout DS® device
orders over the length of the term. Miraculins would be responsible
for leading the CFDA clearance process and its related costs.
Cachet would provide guidance and support for the process as
necessary.
Scout DS® has received regulatory clearance in Canada and
throughout the European Union, and Miraculins has recently filed
pre-submission documentation with the USFDA (United States Food and
Drug Administration) towards securing Scout DS® marketing clearance
in the United States.
Upon clearance of the Scout DS® in China, Cachet would be
responsible for all sales and marketing costs. Miraculins would
provide sales and marketing guidance and support as required, and
would provide a limited number of not-for-sale devices to Cachet
for use in market development activities. Miraculins would retain
the right to establish programs for ongoing device servicing and
maintenance once the Scout DS® devices are sold into the field.
"This would be a truly transformative agreement for Miraculins
as a company and for Scout DS® as a ground-breaking healthcare
technology," stated Christopher J. Moreau, President and CEO of
Miraculins. "As a distributor of major brands throughout China such
as Bayer, Novartis, Johnson & Johnson, and Medtronic, executing
an exclusive distribution agreement with Cachet would be a highly
significant step forward as we continue our drive to see Miraculins
become a world-class diagnostic, risk assessment and health
screening force on the global stage."
The Term Sheet provides Cachet with an exclusive period of
ninety days within which to finalize definitive documentation for
the Agreement. The completion of the definitive documentation and
the execution of the Agreement remain subject to all necessary
contractual, regulatory and corporate approvals of both Miraculins
and Cachet and the completion of satisfactory due diligence. The
Term Sheet provisions are not legally binding except for provisions
regarding exclusivity, confidentiality and governing law. It is
anticipated that definitive documentation will be completed within
90 days. There is, however, no assurance that the parties will
enter into definitive documentation or execute the Agreement
contemplated by the Term Sheet.
About Cachet Pharmaceutical Co., Ltd.
Founded in 1998, Cachet Pharmaceutical Co., Ltd. is a majority
state-owned stock company with a market capitalization of 4 Billion
RMB ($654 Million USD). Cachet's largest shareholder, the China
Youth Industrial Development Corporation, belongs directly to the
Central Committee of the Communist Youth League of China. On August
18, 2010, Cachet went public on the Shenzhen Stock Exchange (stock
name: Cachet; stock code: 002462). Cachet Pharmaceutical Co., Ltd.
engages in the wholesale and retail sale of pharmaceutical products
in China. The company is involved in the supply of medicines to
hospitals; wholesale of biological products, medical instruments,
and traditional Chinese medicines; and pharmaceutical logistics. It
additionally owns 150 chain stores in Beijing that sell medicines,
health care food, medical instruments, cosmetics, daily
necessities, and traditional Chinese medicines.
About Miraculins Inc.
Miraculins is a medical diagnostic company focused on acquiring,
developing and commercializing non-invasive technologies for unmet
clinical needs. A significant number of promising diagnostic
opportunities remain un-commercialized because of the sizable gap
between the discovery stage, when research institutions are
typically involved, and the commercialization stage, when the
larger commercial enterprises become interested. Miraculins has
direct experience in bridging this gap. The Company's PreVu® POC
Test is a revolutionary new coronary artery disease risk assessment
technology that measures cholesterol levels in a patient's skin
non-invasively, painlessly and without the need for fasting. The
Company's Scout DS® system is the first non-invasive diabetes
testing system designed to provide a highly sensitive and
convenient method for measuring diabetes related biomarkers in the
skin, the accumulation of which are accelerated by abnormal blood
sugar levels and oxidative stress. Unlike current testing methods,
a Scout DS® test requires no blood draw, no fasting, and no waiting
for a lab result. The product has been used and validated in
thousands of patients around the world. The Company's preeclampsia
program is partnered with Alere Inc., one of the world's largest
diagnostic companies. For more information visit
www.miraculins.com
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release
constitute forward-looking information within the meaning of
applicable Canadian provincial securities legislation
(collectively, "forward-looking statements"). These forward-looking
statements include statements regarding the completion of
definitive documentation and the execution of the Agreement, the
receipt of CFDA regulatory clearance, and the impact of the
Agreement on the Company. These forward-looking statements relate
to, among other things, our objectives, goals, targets, strategies,
intentions, plans, beliefs, estimates and outlook, including,
without limitation, our anticipated future operating results, and
can, in some cases, be identified by the use of words such as
"believe," "anticipate," "expect," "intend," "plan," "will," "may"
and other similar expressions. In addition, any statements that
refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking
statements.
These statements reflect management's current beliefs and
are based on information currently available to management. Certain
material factors or assumptions are applied in making
forward-looking statements, and actual results may differ
materially from those expressed or implied in such statements.
Important factors that could cause actual results to differ
materially from these expectations include, among other things:
Miraculins' early stage of development, lack of product revenues
and history of operating losses, uncertainties related to clinical
trials and product development, rapid technological change,
uncertainties related to forecasts, competition, potential product
liability, additional financing requirements and access to capital,
unproven markets, supply of raw materials, income tax matters,
management of growth, partnerships for development and
commercialization of technology, effects of insurers' willingness
to pay for products, system failures, dependence on key personnel,
foreign currency risk, risks related to regulatory matters and
risks related to intellectual property and other risks detailed
from time to time in Miraculins' filings with Canadian securities
regulatory authorities, as well as Miraculins' ability to
anticipate and manage the risks associated with the foregoing.
Additional information about these factors and about the material
factors or assumptions underlying such forward-looking statements
may be found in the body of this news release. Miraculins cautions
that the foregoing list of important factors that may affect future
results is not exhaustive. When relying on Miraculins'
forward-looking statements to make decisions with respect to
Miraculins investors and others should carefully consider the
foregoing factors and other uncertainties and potential
events.
These risks and uncertainties should be considered carefully
and prospective investors should not place undue reliance on the
forward-looking statements. Although the forward-looking statements
contained in this press release are based upon what management
believes to be reasonable assumptions, Miraculins cannot provide
assurance that actual results will be consistent with these
forward-looking statements. Miraculins undertakes no obligation to
update or revise any forward-looking statements.
PreVu® and Scout DS® are
registered trademarks of Miraculins Inc. All Rights Reserved.
2014.
Miraculins Inc.Christopher J. MoreauPresident &
CEO204-477-7599204-453-1546info@miraculins.comwww.miraculins.com
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