Attached files
| file | filename |
|---|---|
| EX-10.2 - PROMISSORY NOTE, DATED NOVEMBER 18, 2016. - Echo Therapeutics, Inc. | ex10-2.htm |
| 8-K - FORM 8-K - Echo Therapeutics, Inc. | ecte8k_nov182016.htm |
Exhibit 10.1
Amendment
# 2 to the
License, Development and
Commercialization Agreement
Between
Echo Therapeutics,
Inc.
And
Medical
Technologies Innovations, Asia,
Ltd.
1
EXECUTIVE
SUMMARY
1.1
Scope. This
amendment covers the activities necessary to support the Chinese
commercialization of the “Core 2+ and “Generation
3” versions of the Echo CGM system, as defined below. This
Amendment # 2 will take effect, and is conditioned upon receipt of
$500,000 in additional bridge loans on or before November
30th.
1.2 Amended
Terms. The terms in the Original Agreement remain in force,
except as described below.
1.3 Product
Definition. The definition of “Product”
contained in Section 1.1.59 is amended to include the
following:
|
Release
|
Device
|
Description
|
Echo
Deliverables
|
MTIA
Responsibilities
|
|
Core
2+
|
System
|
Support
as needed plus deliverables listed below. Evaluation and testing of
MTIA produced materials, as needed.
|
Prototype
construction, preliminary clinical testing in China. Manufacturing,
CFDA clinical testing, regulatory approval,
commercialization.
|
|
|
Sensor
Module & Target Base
|
Gen 1
CoPhthal Electrode, dried hydrogel, plastic case. Target Base with
adhesive.
|
Design
changes, test reports.
|
Final
changes to design and testing as needed.
|
|
|
Disposable
Kit
|
Disposable package,
containing the single use devices. Updates include new Tip, BZK
wipe, Reference ring & labeling
|
None.
|
Update
to Bill of Materials, contents, packaging & labeling. Shelf
life & other testing as needed.
|
|
|
Transmitter
|
Bluetooth
transmitter and embedded firmware.
|
Firmware executable
program and PC based test program.
|
Testing
as needed.
|
|
|
Glucose
Algorithm
|
Signal
processing software and configuration parameters.
|
Executable program
and baseline configuration parameters. PC based test
tool.
|
Final
configuration parameters, testing as needed.
|
|
|
Exfoliator
|
Skin
exfoliator, with embedded control firmware and configuration
parameters.
Battery
charger.
|
Design
documentation, sample prototypes. Firmware executable program,
configuration parameters and PC based test program.
|
Final
configuration parameters, testing as needed. Exfoliator tip
production.
Battery
charger design, development and testing.
|
|
|
API
|
Application
Programming Interface, running on Android
|
Executable software
(Android), test reports and interface document.
|
None.
|
|
|
App
|
CGM
Application with Graphical User Interface.
|
Example
English App with source code and executable (Android).
|
Software
development of Chinese App, Testing as needed.
|
|
|
Release
|
Device
|
Description
|
Echo
Deliverables
|
MTIA
Responsibilities
|
|
Generation 3 and
all future generations of our CGM product(s)
|
System
|
Requirements,
design, implementation, testing and preliminary clinical testing.
Software and algorithm design.
Evaluation and
testing of MTIA produced materials, as needed.
|
User
documentation, Shipping packaging & labeling. Preliminary
clinical testing in China. Manufacturing, CFDA clinical testing,
regulatory approval, commercialization.
|
|
|
Sensor
Module & Target Base
|
Electrode, Wet
Hydrogel and plastic carrier
|
Design
documentation, Design test reports, pilot production, sample
prototypes
|
Plastic
part tooling & part
manufacturing.
|
|
|
Disposable
Kit
|
Sterile, disposable
package, containing the single use devices (Tip, Target Base,
Sensor, Hydrogel, Tray, Packaging)
|
Design
documentation, Design test reports, pilot production, sample
prototypes
|
Plastic
part tooling & part
manufacturing.
|
|
|
Transmitter
|
Reusable, battery
operated transmitter and embedded firmware
|
Design
documentation, Design test reports and sample prototypes. Firmware
executable program and PC based test program.
|
Plastic
part tooling & part
manufacturing
|
|
|
Glucose
Algorithm
|
Signal
processing software that produces glucose values
|
Executable software
and configuration parameters. Design test reports
|
|
|
|
Exfoliator
|
Self-use
Exfoliator, with embedded firmware.
|
Design
documentation, Design test reports and sample prototypes. Firmware
executable program and PC based test program.
|
Plastic
part tooling & part
manufacturing
|
|
|
API
|
Application
Programming Interface, running on Android
|
Executable software
(Android), test reports and interface document.
|
None.
|
|
|
App
|
Chinese
CGM Application
|
Example
English App with source code and executable (Android).
|
Software
development of Chinese App, Testing as needed.
|
|
2
DEVELOPMENT
PROJECT
2.1 Work
Plan and Overview. Echo and MTIA will cooperate in the
development of a project Overview and a more detailed Work Plan.
This work plan will describe the responsibilities of each company
for the development of the devices described above, in
“Product Definition”. In the event that a change is
needed in the definition of these deliverables, this will be made
with mutual consent, in an update to the work plan.
2.2 Software
Development. Echo will provide an Application Programming
Interface (API) to facilitate the development by MTIA of
application software for both Core 2+ and Generation 3. Echo will
develop and provide source code for an example application using
the API. The MTIA application software will be developed by MTIA
based on requirements MTIA defines. Echo will provide executable
versions of the software for the Exfoliator, Transmitter and
API.
2.3 Technology
Transfer. Echo will provide documentation and training to
MTIA to ensure that MTIA has the knowledge necessary to manufacture
the devices described in the “Product Definition”
above.
2.4
Development
Schedules. Both companies will publish to each other, Gantt
charts showing the activities and end dates needed to produce the
deliverables described in the work plan
2.5
Status Reports.
Both companies will publish bi-weekly status reports to each other,
describing the progress, issues and any significant schedule
updates.
2.6
Conference Calls
-TBD
3
PAYMENTS
The
terms of the Original Agreement apply with the following
exceptions:
3.1 Reimbursement.
There shall be up to $2,000,000 of reimbursement for direct out of
pocket expenses, subject to submission of appropriate documentation
for review and approval by the Company and outside independent
auditors hired by the Company for work done by MTIA, or their
affiliates, on our CGM product in development to date of this
agreement. Reimbursement will be made in the form of a promissory
note payable to MTIA upon consummation of a convertible debt
financing led by MTIA or their affiliates in excess of $5,000,000
of gross proceeds. The form of the promissory note will be the same
form as those issued in the financing. No further reimbursement
will be made by Echo to MTIA for costs involved in the development
of products to obtain CFDA approval or for commercial deployment.
If a convertible debt financing cannot be led by MTIA or their
affiliates, Echo will only reimburse up to a maximum of $1,500,000
upon CFDA approval of the products through the same promissory note
as stated in accordance with the terms of the Original
Agreement.
3.2 Prototypes.
MTIA will reimburse Echo for the real and actual costs of producing
and shipping prototype samples delivered to MTIA clinical testing,
demonstration and other purposes, for the products described above
in the “Product Definition”.
3.3 Plastic
Parts and Tooling. MTIA will provide the tooling for the
plastic parts needed for the products described above in the
“Product Definition”. MTIA or their affiliates will
also be responsible to provide these products to Echo for design
testing, clinical testing, demonstration and other purposes. Echo
will reimburse MTIA or their affiliates for the real and actual
costs of producing and shipping manufactured parts for these
products.
4.
NOTICES
4.1
All notices to Echo
shall be sent to:
Echo
Therapeutics, Inc.
295
Foster Street
Littleton, MA
01460
Attention: Chief
Financial Officer
with a
copy to:
Kevin
W. Waite, Esq.
Moomjian, Waite
& Coleman, LLP
100
Jericho Quadrangle, Suite 208
Jericho, NY
11753
IN
WITNESS WHEREOF, the Parties, intending to be legally bound hereby,
have caused their duly authorized representatives to execute this
Agreement as of the Effective Date.
ECHO
THERAPEUTICS, INC.
By:
/s/ Alan W.
Schoenbart________
Name:
Alan W.
Schoenbart
Title:
CFO
MEDICAL
TECHNOLOGIES INNOVATION ASIA, LTD.
By:
/s/ Bai
Ge__________________
Name:
Bai Ge
Title:
Managing
Director