EXHIBIT 10.30

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

Statement of Work No. Two

 

THIS STATEMENT OF WORK NO. TWO (“SOW”) is effective as of June 2, 2017 (the “SOW
Effective Date”) by and between HTG Molecular Diagnostics, Inc. (“HTG”) and
QIAGEN Manchester Limited (“QIAGEN”). This SOW is made a part of, and shall be
governed by, the terms and conditions of the Master Assay Development,
Commercialization and Manufacturing Agreement (the “MSA”) executed between the
Parties dated as of November 16, 2016. In the event of a conflict between the
terms and conditions of this SOW and those of the MSA, this SOW shall govern.

1.

Sponsor Project Agreement and Supplement Agreement. This SOW covers the
performance by each Party of its respective activities in support of the
Development of the PDP Assay that is the subject of the Sponsor Project
Agreement, identified as the Initiation Agreement, dated June 2, 2017
(“Effective Date of Sponsor Project Agreement”), between QIAGEN and the
pharmaceutical company referenced therein (“PHARMA”). Concurrently with the
execution of this SOW, PHARMA, QIAGEN and HTG are entering into a Supplement
Agreement (the “Supplement Agreement”).

2.

Definitions. The terms in this SOW with initial letters capitalized, whether
used in the singular or the plural, shall have the meaning set forth in this
SOW, or if not defined in this SOW, shall have the meaning set forth in the MSA,
or if not defined in this SOW or the MSA, shall have the meaning set forth in
the Supplement Agreement, or if not defined in this SOW, the MSA or the
Supplement Agreement, shall have the meaning set forth in the Sponsor Project
Agreement, in the form delivered by QIAGEN to HTG on August 24, 2017.

 

3.

Term. This SOW shall commence as of the SOW Effective Date and shall expire on
the date on which the last of the following occurs: (i) completion of all
Development activities specified in this SOW, or (ii) receipt by HTG of payment
of all amounts due to HTG (including any profit sharing) under this SOW; unless
this SOW is earlier terminated in accordance with its terms or the terms of the
MSA.

4.

Development Work

 

4.1.

Development Objectives. Development activities under this SOW, generally, are
directed to the following objectives (collectively, the “Project”), all or part
of which may occur in series or in parallel as circumstances may dictate:

 

4.1.1.

Project initiation;

HTG/QIAGEN CONFIDENTIALPage 1 of 6

--------------------------------------------------------------------------------

 

 

4.1.2.

Design of an assay for NGS detection of mRNA expression of a mutually approved
number of genes in conformance with applicable FDA regulations for use in
[…***…] PHARMA’s clinical studies (the “Clinical Trial Assay” or “CTA”).

 

4.1.3.

Development of the CTA.

 

4.1.4.

Engage and qualify one or more mutually approved […***…] clinical testing
site(s) for performance of PHARMA’s clinical studies involving the retrospective
testing of a mutually approved number and type of biological samples with the
CTA (“Retrospective Testing”).

 

4.1.5.

Conduct, or cause to be conducted, the Retrospective Testing.

 

4.2.

Development Activities. In furtherance of the foregoing Development objectives,
the Parties confirm that they have exchanged details of their respective
Development activities for mutual review and approval prior to the full
execution of this SOW (“Work Plan”). Each Party shall use commercially
reasonable efforts to complete its respective Development activities in the Work
Plan in a time- and cost-efficient manner and otherwise in conformance with this
SOW and Section 3 of the MSA.

 

4.3.

As provided in the Section 3.7 of the MSA, each Party’s Project Lead shall keep
the other Party, and (if applicable) PHARMA, updated and consult with such other
Party on a reasonably regular basis with respect to all the Development work
being conducted by such Party. Without limiting the generality of the foregoing,
the responsible Party shall, to the extent reasonably feasible:

 

4.3.1.

Invite a reasonable number of representatives of the other Party to attend any
formal design reviews (“FDR”) that occur as part of the responsible Party’s
Development activities under this SOW.

 

4.3.2.

Make final or near-final “Deliverables” (as provided in Section 5) available to
the other Party for review; provided that such other Party’s review shall not
delay the corresponding Development milestone or other obligation of the
responsible Party related to such Deliverable.

 

4.3.3.

Subject to the responsible Party’s independent professional judgment in
accordance with the applicable provisions of this SOW (as provided in Section
3.4 of the MSA), the responsible Party agrees to consider, in good faith,
comments or requests timely received from the non‑responsible Party regarding
Deliverables or FDR-related topics.

 

4.4.

In the event of a Project Delay or if PHARMA rejects any deliverable based upon
quality issues attributed to HTG’s Development work under this SOW, Section 3.9
of the MSA shall apply.

HTG/QIAGEN CONFIDENTIALPage 2 of 6

--------------------------------------------------------------------------------

 

 

4.5.

QIAGEN Materials. Except to the extent HTG expressly has agreed to provide
Samples (as defined in the MSA) for all or part of its Development activities,
QIAGEN shall timely deliver, or cause PHARMA to timely deliver, to HTG all
Samples and other QIAGEN Materials (as defined in the MSA) necessary for HTG to
perform its Development activities hereunder. Samples (as defined in the MSA),
and all reagents, data and information relating to the Samples or the use of the
Samples, delivered to HTG by or on behalf of PHARMA pursuant to this Section 4.5
shall be deemed QIAGEN Materials (as defined in the MSA) for purposes of this
SOW.

5.

Milestones, Deliverables and Related Matters. Development activities for this
SOW are directed to achieve certain milestones and, for each milestone, the
delivery to PHARMA of one or more Deliverables. The applicable milestones,
Deliverables, Party responsible for completion of each Deliverable, target (or,
as applicable, due) dates, and expected PHARMA milestone payments are set forth
in the Work Plan. Upon completion of each Deliverable for which HTG is
responsible, HTG shall deliver such Deliverable to QIAGEN. Upon receipt from HTG
or upon completion by QIAGEN, as applicable, QIAGEN shall deliver all
Deliverables to PHARMA and promptly notify HTG when such Deliverable has been
accepted (or, as applicable, rejected) by PHARMA. QIAGEN shall also invoice, and
receive applicable payment(s) from, PHARMA in accordance with the terms and
conditions of the Sponsor Project Agreement. QIAGEN shall promptly notify HTG in
writing of any payments received from PHARMA pursuant to the Sponsor Project
Agreement.

6.

Compensation Arrangement

 

6.1.

Allowable Project Costs. For purposes of this SOW, allowable Project Costs for
the respective Parties shall include direct employee costs, materials and other
direct expenses, capital purchases, and subcontractor expenses, as follows:

 

6.1.1.

Direct employee costs shall be tracked on a daily basis by project calculated
using the daily Wage Rate (defined below) applicable to each employee performing
Development activities under this SOW. The Steering Committee shall, at an
appropriate time, determine a mutually acceptable process for daily time
tracking.

 

6.1.1.1.

For purposes of this subsection, the “Wage Rate” shall be an average salary for
similarly-situated employees performing specified skills-based functions plus a
Payroll Burden Rate, and will not be the actual wage paid each specific
individual who performs Development work. For purposes of this subsection, the
“Payroll Burden Rate” will include the expense for payroll taxes, vacation,
accrued bonus, group insurance (representing workers’ compensation insurance,
health insurance and life and disability insurance), stock compensation and
payroll service fees representative of the employee mix performing the
applicable Development activities.

HTG/QIAGEN CONFIDENTIALPage 3 of 6

--------------------------------------------------------------------------------

 

 

6.1.1.2.

Wage Rates will be recalculated every six months in June and December of each
calendar year, and utilized for the immediately following six‑month period. Upon
request, each Party shall provide the other Party reasonable documentary support
for its Wage Rate calculations.

 

6.1.2.

Material and other direct costs are all directly incurred expenses associated
with Development activities. These expenses are expected to include materials
used internally or provided by a Party to subcontractors (including a Party’s
product inventory and supplies purchased from a third party), direct travel
required for the Development activities, and any other mutually approved direct
expenses. Amounts invoiced to a Party by any third‑party subcontractor shall not
be a direct cost under this subsection.

 

6.1.3.

Capital purchases shall be the acquisition cost of any capital asset that is to
be used solely for Development activities. Any such capital purchases by either
Party must be approved in writing by the non-purchasing Party prior to purchase.
Upon completion of the Development activities in this SOW, any remaining value
attributable to the purchased capital asset (as determined in accordance with US
GAAP) shall be credited back to the Net Profit share (see below). HTG shall
specifically itemize any approved capital purchases in invoices to QIAGEN.

 

6.1.4.

Subcontractor expense shall be the actual cost invoiced to a Party by any
permitted third-party subcontractor that performs Development activities.
Materials provided to a permitted subcontractor, such as assay kits, for use by
such subcontractor to perform Development activities are subject to Section
6.1.2 (and not this subsection) and will be billed at cost.

 

6.2.

Project Costs Acknowledgment or Overage.

 

6.2.1.

The Parties have exchanged their estimated Project Costs for mutual review and
approval prior to the full execution of this SOW. Such approved estimated
Project Costs shall not be modified unless the Parties confer in good faith to
determine the desirability of such modification, and no modification, change or
amendment to approved estimated Project Costs will be effective until revised
estimated Project Costs are received and approved by both Parties.  

 

6.2.2.

In the event actual Project Costs are expected to exceed the estimated Project
Costs by […***…]% or more, the Party expecting to incur such cost overages shall
notify the other Party as soon as possible, and, where possible, prior to
incurring the overages and, in HTG’s case, prior to invoicing QIAGEN. The
Steering Committee shall meet promptly following receipt by the applicable Party
of the overage notice to discuss the circumstances. Where overages are
identified, the Parties shall work in good faith to agree to a reasonable
reimbursement solution based upon the facts and circumstances that have led to
the overage, and agreement should be made in writing within one month of

HTG/QIAGEN CONFIDENTIALPage 4 of 6

--------------------------------------------------------------------------------

 

the overage being identified. No amounts in excess of […***…]% of the original
estimated Project Costs should be included in Development Net Profit
calculations without mutual agreement of the Parties.

 

6.3.

HTG Development Fee: QIAGEN shall pay HTG for the Development work performed by
HTG on a monthly, fee-for-service basis (the “HTG Development Fee”). The HTG
Development Fee shall be the amount of allowable HTG Project Costs actually
incurred in the applicable period plus […***…]% of such allowable HTG Project
Costs as a management and administration fee (which fee shall, for purposes of
Section 6.5 below, be deemed HTG Project Costs).

 

6.3.1.

Invoices for the HTG Development Fee will be submitted by HTG to QIAGEN on a
monthly basis containing the applicable purchase order number provided by
QIAGEN, and will be due within […***…] days from the date of receipt of invoice
by QIAGEN. Payment of such invoices will occur regardless of whether QIAGEN has
collected payments from or invoiced PHARMA. In no event will QIAGEN be obligated
to make any pre‑payments to HTG for services or Deliverables.

 

6.4.

QIAGEN Project Costs: QIAGEN shall retain for itself (subject to Net Profit
accounting) allowable QIAGEN Project Costs for Development work performed in the
period corresponding to each PHARMA payment plus […***…]% of such allowable
QIAGEN Project Costs as a program management and administration fee (which fee
shall, for purposes of Section 6.5 below, be deemed QIAGEN Project Costs).

 

6.5.

Profit Sharing. Except to the extent otherwise provided in this subsection, Net
Profit shall be determined as provided in Section 5.2.4 of the MSA. Within
[…***…] business days after the end of each calendar quarter, QIAGEN will
prepare and deliver to HTG an initial calculation of Net Profit for the
then‑ended calendar quarter (“Applicable Period”), including all amounts paid by
PHARMA to QIAGEN under the Sponsor Project Period during the Applicable Period.
The support for the Net Profit calculation will include documentary evidence of
allowable Project Costs for HTG and QIAGEN for the Applicable Period, including,
for example, timesheets and copies of invoices received from third parties and
subcontractors. No later than […***…] business days after HTG’s receipt of the
initial Net Profit calculation, the Parties shall meet as provided in the MSA
and approve the Net Profit amount for the Applicable Period. The Parties shall
each receive 50% of the mutually approved Net Profit amount. HTG will issue an
invoice to QIAGEN containing the relevant purchase order number provided by
QIAGEN for HTG’s Net Profit amount. QIAGEN shall pay HTG’s Net Profit amount
within […***…] days of receiving the applicable invoice. Upon completion of this
SOW, being […***…] days after acceptance of the final deliverable by PHARMA; a
true-up calculation of each party’s total costs should be performed in
comparison to the total amounts paid by PHARMA to determine the overall Net
Profit. A comparison of the amounts paid to HTG for each quarter’s Net Profit
will be made and a final invoice issued by either HTG to

HTG/QIAGEN CONFIDENTIALPage 5 of 6

--------------------------------------------------------------------------------

 

QIAGEN or QIAGEN to HTG, as applicable, to ensure an overall 50% share of the
total Net Profit amount. The invoice will be paid by the relevant party within
[…***…] days of receipt.

7.

Subsequent Statements of Work. The terms and conditions of one or more
statements of work related to further Development activities or the
manufacturing or commercialization of the subject PDP Assay shall be negotiated
by the Parties as provided in the MSA.

8.

Intellectual Property. Intellectual Property Rights (as defined in the MSA)
among HTG, QIAGEN and PHARMA with respect to the Development activities shall be
set forth in the Supplement Agreement.

9.

Confidentiality. Certain rights and obligations among HTG, QIAGEN and PHARMA
concerning confidential and proprietary information related to the Development
activities shall be set forth in the Supplement Agreement.

10.

SOW Suspension and Termination. This SOW may be suspended or terminated as
specified in the MSA, as it may be amended from time to time; provided that
notwithstanding anything in Section 13.3.2 of the MSA to the contrary, in the
event of a Change of Control, neither Party shall have the right to terminate
this SOW or the MSA to the extent it relates to this SOW.

11.

Supplement Agreement.  HTG and QIAGEN shall execute this SOW concurrently with
the execution of the Supplement Agreement by PHARMA, QIAGEN and HTG, and if this
SOW is not so executed concurrently with the Supplement Agreement, this SOW and
the Supplement Agreement shall each be null and void and of no force or effect.

IN WITNESS WHEREOF, HTG and QIAGEN each has caused this SOW to be executed by
its respective duly authorized representative effective as of the SOW Effective
Date.

 

HTG MOLECULAR DIAGNOSTICSQIAGEN MANCHESTER LIMITED

 

 

By:/s/ Timothy B. JohnsonBy:/s/ Douglas Liu

 

Name:Timothy B. JohnsonName:Douglas Liu

 

Title:President, Chief Executive OfficerTitle:SVP Global Operations

 

 

HTG/QIAGEN CONFIDENTIALPage 6 of 6