HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Files An 8-K Entry into a Material Definitive Agreement

Item 1.01

Master Assay Development, Commercialization and Manufacturing
Agreement

Effective November 16, 2016, HTG Molecular Diagnostics, Inc. (the
Company) entered into a Master Assay Development,
Commercialization and Manufacturing Agreement (the Agreement)
with QIAGEN Manchester Limited (QIAGEN or QIAGEN Manchester), a
U.K. corporation and wholly owned subsidiary of QIAGEN N.V. The
Agreement serves as a master agreement for the parties to
collaborate with respect to the development and commercialization
of next generation sequencing based companion diagnostic assays
for clinical use in the oncology field, for which the
collaboration is exclusive. The Agreement also provides a
framework for potential collaboration in the autoimmune and
microbiome fields, as well as other fields that may be agreed to
by the parties, for which the collaboration is non-exclusive.

Under the Agreement, the parties intend to jointly seek to enter
into sponsor project agreements with pharmaceutical companies, to
which the Company and QIAGEN would develop companion diagnostic
assays in the oncology field to support the applicable
pharmaceutical companys therapeutic development and
commercialization programs. Development work is expected to be
conducted under individual statements of work, which would be
negotiated and agreed to by the Company and QIAGEN in conjunction
with each sponsor project agreement. QIAGEN will pay the Company
for development work performed under the Agreement, and the
parties would also share in the net profits (as determined under
the Agreement) generated by individual projects.

Once development work is completed, it is expected that QIAGEN
would conduct the clinical and regulatory work necessary to
obtain regulatory approvals for the applicable assay(s). Assays
based primarily on the Companys intellectual property rights
would be manufactured and supplied by the Company to a
manufacturing and supply agreement to be negotiated and entered
into by the parties. QIAGEN would purchase Company-developed
assays from the Company, and be responsible for marketing,
selling and commercializing assays developed under the Agreement.
For sales of QIAGEN-developed assays, QIAGEN would pay the
Company a royalty at a rate to be established in each applicable
statement of work.

The Agreement has a term of five years, and is subject to earlier
termination by either party for material breaches. The Agreement
may also be terminated by either party in the event of a change
in control involving either party; provided, however, that, in
the event a party terminates the Agreement as a result of its own
change in control, it will be required to pay a termination fee
of USD $2.0 million.

In addition, the Agreement will become non-exclusive if the
parties do not achieve certain agreed goals.

Stock Purchase Agreement

Effective November 16, 2016, the Company entered into a Stock
Purchase Agreement with QIAGEN North American Holdings, Inc.
(QIAGEN North American), an entity affiliated with QIAGEN
Manchester, to which the Company agreed to sell, and QIAGEN North
American agreed to purchase, up to $4.0 million of the Companys
common stock. QIAGEN North American agreed to purchase, at an
initial closing, 833,333 shares of common stock at a price per
share of $2.40, for an aggregate purchase price of approximately
$2.0 million. QIAGEN North American also agreed to purchase up to
an additional $2.0 million of the Companys common stock upon the
sale by the Company of at least $12.0 million of common or
preferred stock in a financing transaction that occurs prior to
May 16, 2017. The price per share payable by QIAGEN North
American in the second closing will be equal to the price per
share at which shares are sold in the subsequent financing,
subject to certain limitations and adjustments.

QIAGEN North American also agreed to certain transfer
restrictions with respect to the shares it acquires under the
Stock Purchase Agreement. It has further agreed to certain
standstill provisions whereby, subject to certain exceptions,
QIAGEN North American and its affiliates are obligated to refrain
from taking certain actions with respect to the Companys common
stock.

The information contained under Item 1.01 of this report relating
to the issuance and sale of the Companys common stock to the
Stock Purchase Agreement is incorporated in this Item 3.02 by
reference.

The shares will be issued in a private placement transaction
exempt from registration to Section 4(a)(2) of the Securities Act
of the 1933, as amended (the Securities Act). In connection with
QIAGEN North Americans execution of the Stock Purchase Agreement,
QIAGEN North American represented to the Company that it is an
accredited investor as defined in Regulation D of the Securities
Act and that the securities to be purchased by QIAGEN North
American are being acquired solely for its own account and for
investment purposes and not with a view to the future sale or
distribution by QIAGEN North American. Appropriate legends will
be affixed to the shares upon issuance.

About HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM)

HTG Molecular Diagnostics, Inc. is a commercial-stage company that develops and markets a technology platform to facilitate the routine use of complex molecular profiling. The Company’s HTG Edge and HTG EdgeSeq platforms, consisting of instrumentation, consumables and software analytics, are used in sample profiling applications, including tumor profiling, molecular diagnostic testing and biomarker development. The Company’s HTG Edge and HTG EdgeSeq platforms automate the molecular profiling of genes and gene activity using its nuclease protection chemistry on a range of biological samples. The Company’s HTG EdgeSeq chemistry, together with its HTG Edge or HTG EdgeSeq instrumentation and software, automates and adapts its nuclease protection chemistry to enable analysis using next generation sequencing (NGS) instrumentation. The HTG EdgeSeq system utilizes substantially the same sample preparation reagents as its original chemistry, but allows for read out on an NGS instrument.

HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) Recent Trading Information

HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) closed its last trading session up +0.21 at 2.20 with 39,471 shares trading hands.