Exhibit
10.1
EXCLUSIVE COLLABORATION AND
DISTRIBUTION AGREEMENT
THIS EXCLUSIVE COLLABORATION AND DISTRIBUTION
AGREEMEN T
(“Agreement”) is made as of this 17 th day
of June, 2005 (“Effective Date”), by and between
InforMedix, Inc., a Delaware corporation with offices at
Georgetowne Office Park, 5880 Hubbard Drive, Rockville, MD 20852
(“Vendor”), and invivodata, Inc., a Delaware
corporation with offices at 2100 Wharton Street, Suite 505,
Pittsburgh, PA 15203 (“Distributor”).
WHEREAS , Vendor has developed an electronic device and
backend software application (the “Med-eMonitor TM
System”) providing for the storage and dispensing of
medication, and the collection and monitoring of medication
compliance and patient outcomes data and is desirous of utilizing
Distributor’s distribution channels; and possesses certain
Intellectual Property; and
WHEREAS , Distributor is established in the field of
electronic patient recorded outcomes for clinical trials
(“ePRO”) and is desirous of obtaining the right to
market and distribute Vendor’s products, as set forth below;
and
WHEREAS , each of the parties wish to collaborate in
their efforts to develop and implement a marketing and sales
program for the Med-Monitor System;
NOW THEREFORE , in consideration of the promises and mutual
covenants contained herein, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, Vendor and Distributor agree as follows:
1.
DEFINITIONS
.
For purposes of this Agreement, the
following terms shall have the meanings set forth below:
Agreement shall mean this agreement plus all
Exhibits.
Alliance shall mean the promises, obligations and duties
performed by both Vendor and Distributor pursuant to the terms of
this Agreement.
Confidential
Information shall have the meaning set forth in Section 6.1
herein.
Customers shall mean those purchasers of the Products
described in Exhibit A .
Distributor
shall mean invivodata,
Inc.
Effective
Date shall be
the date of the Agreement as set forth in the
Introduction.
eDiary
Companies shall
mean those companies competing with Distributor in the ePRO Market
during the term of this Agreement.
ePRO
shall be an acronym which refers to
the words “electronic patient reported outcomes” as
those words are commonly used in describing the collection of data
by patients enrolled in clinical trials sponsored by pharmaceutical
companies.
Intellectual
Property shall
have the meaning set forth in Section 5.5 herein.
Market shall mean the market for electronic patient
reported outcomes (“ePRO”) devices and services for the
clinical drug trials industry, including Clinical Drug Trials
Phases I through IV.
Marks shall have the meaning set forth in Section 5.1
herein.
Master Equipment Lease
Agreement shall
mean an agreement between Distributor and Vendor for the lease of
Med-eMonitor TM Device units as set forth in Exhibit
F .
Master License and
Services Agreement shall mean an agreement describing the terms
upon which Distributor will obtain and Vendor will provide certain
services to Distributor and / or its Customers in connection with
the deployment, implementation, customization and support of the
Med-eMonitor System as set forth in Exhibit G .
Med-eMonitor
TM Device shall mean the patented device invented and
manufactured by Vendor and used by patients, that physically
contains, organizes, and monitors medication. The device includes a
handheld device and a cradle. The handheld device contains an LCD
screen, a variety of buttons, and medication storage. The cradle
contains a communications modem, and battery charging
capability.
Med-eMonitor
TM Firmware shall mean the software embedded in the
Med-eMonitor TM Device that operates the device, and
provides for communications linkage with the Med-eXpert
database.
Med-eMonitor
TM System shall mean the combination of hardware and
software comprising the Med-eMonitor TM Device,
Med-eMonitor TM Firmware, Med-eXpert TM
Backend Software, and Med-eXpert TM Database providing
for the storage and dispensing of medication, and the collection
and monitoring of medication compliance and patient outcomes
data;
Med-eXpert TM
Backend Software shall mean the software that provides for a
real-time protocol design tool that programs the Med-eMonitor
devices with the ePRO protocols, and that enables analysis and
reporting of data captured by the Med-eMonitor TM
Device.
Med-eXpert TM
Backend System shall have the same meaning as the Med-eXpert
TM Backend Software.
Med-eXpert TM
Database shall mean the database which stores all data
captured by the Med-eMonitor TM Device and/or any other
device with is operated by the Med-eXpert TM Backend
Software.
Products
shall mean those products or
services to be leased, licensed or sold by Vendor to Distributor
for distribution hereunder as such products, including upgrades and
enhancements, as described in Exhibit A attached hereto, and
as may be amended upon the mutual agreement of the
parties.
Purchase. The term purchase shall refer to any procurement
of Vendor Products or Services through the execution of a either
the Master Equipment Lease Agreement as set forth in Exhibit F, or
Master License and Services Agreement as set forth in Exhibit
G .
Services shall mean those services to be performed by
Vendor to Distributor as described in Exhibit A attached
hereto, as may be amended upon mutual agreement of the
parties.
Solutions shall mean any value creation opportunity that
may satisfy a business need of Customers resulting from some
application of the Med-eMonitor TM System.
Taxes shall have the meaning set forth in Section 3.2
herein.
Term shall have the meaning set forth in Section 9.1
herein.
Vendor shall mean InforMedix, Inc.
Work
Statement shall
have the meaning set forth in the Master License and Services
Agreement attached to this Agreement as Exhibit G
.
2.
APPOINTMENT; EXCLUSIVITY;
COLLABORATION ON MARKETING AND SALES; OBLIGATIONS OF THE
PARTIES .
(a) Subject to the terms and conditions contained
herein, Vendor hereby appoints Distributor to be the exclusive and
sole worldwide distributor among competitive eDiary Companies of
the Products and Services described in Exhibit A within the
Market. For purposes of this Agreement, “exclusive and sole
worldwide distributor” means that Vendor shall not appoint
any other eDiary Company as distributor with express or implied
authority to sell goods or establish locations anywhere in the
world with respect to the Market during the Term of this Agreement;
provided , however , that nothing set forth herein
shall preclude Vendor from (i) directly servicing Customers in the
Market, (ii) directly marketing the Products in the Market, or
(iii) directly making sales into or within the Market, provided
that none of Vendor’s direct sales within the Market shall be
to Customers introduced to Vendor by Distributor during the term of
this Agreement.
(b) Vendor shall not knowingly sell Products to a
third party eDiary company who intends to market or sell Products
within the Market.
2.2 INTENTIONALLY LEFT BLANK
2.3
Collaboration on Business
Planning, Marketing and Sales
.
(a) Distributor and Vendor shall co-develop a
strategic plan which describes in detail the Alliance strategy for
marketing, distributing, servicing and supporting the Products in
the Market during the Term of this Agreement. The Strategic Plan
shall be reviewed and updated by the parties as necessary on a
regular basis. Distributor and Vendor each represents and warrants
that it shall use its commercially reasonable efforts to take the
actions and achieve the goals set forth in the Strategic
Plan.
(b) Distributor and Vendor agree to work in good
faith to continuously and periodically update such Strategic Plan
to assure that it is relevant to current market
conditions.
(c) Distributor and Vendor will work with each
other’s marketing representatives to present the Alliance in
sales materials, trade shows and on the companies’ respective
websites.
(d) Distributor and Vendor agree to issue a press
release to the satisfaction of both parties within two business
days of the effective date of this Agreement, or within a time
period mutually agreed to by the parties, to announce the formation
of the Alliance. Distributor and Vendor shall work together in good
faith to issue timely press releases to the satisfaction of both
parties about significant achievements of the Alliance on an
ongoing basis.
(e) Distributor and Vendor shall identify public
speaking and publication opportunities to present at trade shows
and industry conferences to promote their common
interests.
2.4
Obligations and
Representations of Distributor
.
(a) Distributor represents that it has full power
and authority to enter into this Agreement and perform the
obligations hereunder without violating any agreement with any
third party, or any law or regulation and that the person signing
this Agreement on behalf of it has been duly authorized and
empowered to execute this Agreement. Distributor acknowledges that
it has read this Agreement, understands it, has had the opportunity
to seek legal advice and agrees to be bound by its
terms.
(b)
Distributor represents and
covenants that it shall market the Products within the Market as an
integral part of Distributor’s product line,
worldwide.
(c) Distributor represents and covenants that it
shall perform all obligations under this Agreement in a
commercially reasonable manner.
(d) Distributor shall use all appropriate
Distributor marketing tools to promote the Products with equal
prominence to all other Distributor Products.
(e) Distributor shall deliver marketing materials
describing the Products that contain text, graphics, and format
mutually agreed by both parties. Distributor shall not undertake or
permit removal or alteration of any patent numbers, trade names,
trademarks, notices, nameplates or serial numbers affixed to the
Products and documentation, without Vendor’s prior written
consent.
(f) Distributor shall use its commercially
reasonable efforts in promoting, marketing, supporting and
servicing the Products within the Market, and in fulfilling its
other obligations in this Agreement.
(g) Distributor shall not knowingly sell, transfer
or otherwise provide any Products to persons or entities that are
competing with or developing products to compete with
Vendor.
(h) Distributor shall act in good faith in all its
dealings with Vendor and Customers.
(i) Distributor shall not enter any agreement with
Customers that conflicts with any term or condition of this
Agreement.
(j) Distributor shall comply with the terms of this
Agreement, including all policies, terms, conditions and Vendor
policies attached hereto.
(k) Distributor shall not, while this Agreement is
in force, commence manufacture of any spare parts usable for
service and maintenance of the Products nor shall Distributor
modify any hardware or software with respect to the Products.
Vendor’s warranties shall not apply to non-Vendor
modifications to the Products .
(l) Distributor agrees, to the best of its
knowledge, to comply with all United States or Foreign laws or
regulations, as they may exist from time to time, regarding export
licenses or the control or regulations of exportation or
re-exportation of products or technical data sold or supplied to
Distributor.
(m) Distributor shall pay for the replacement of
any Product or demo device lost during the sales
process.
(n)
Distributor shall maintain adequate
records regarding sales.
(o)
Confidential Obligations and
Representation of Distributor. In addition, Distributor represents and agrees
to be bound by the specified confidential obligations and
representations set forth in Exhibit I .
2.5
Obligations and
Representations of Vendor .
(a)
Vendor shall act in good faith in
all its dealings with Distributor and Customers.
(b)
Vendor agrees to comply with all
United States or Foreign laws or regulations, as they may exist
from time to time, regarding export licenses or the control or
regulations of exportation or re-exportation of products or
techn