EXHIBIT 10.19
EXCLUSIVE MANUFACTURING AND DISTRIBUTION
AGREEMENT
THIS EXCLUSIVE MANUFACTURING AND DISTRIBUTION AGREEMENT (the
“Agreement”) is made and entered into as of the 18th
day of April, 2005, by and between Uroplasty, Inc., 2718 Summer
Street N.E., Minneapolis, Minnesota 55413
(“Uroplasty”), and CystoMedix, Inc., 1887 Station
Parkway N.W., Building #7, Andover, Minnesota 55304 for itself and
all of its wholly-owned subsidiaries (collectively
“CystoMedix”).
RECITALS :
WHEREAS , Uroplasty manufactures and currently markets
outside of the United States a family of injectable implant
products used for soft-tissue augmentation for specific indications
in urology, urogynecology, gynecology, colon and rectal,
otolaryngology and plastic surgery markets;
WHEREAS , CystoMedix is a medical device company that
develops products for patients in the urogynecology and gynecology
markets and has developed, and continues to develop,
neurostimulation devices currently being, or proposed to be,
marketed under the brand names and trademarks (collectively, the
“Trademarks”) URGENT®,
“URGENT-PC™” and “URGENT-SQ™”
(collectively as now existing or hereafter improved, modified or
enhanced, the “Products”);
WHEREAS , subject to FDA and other applicable regulatory
approvals, Uroplasty desires to act as the exclusive manufacturer
and distributor of the Products in the territories named herein,
and CystoMedix desires and is willing to grant such rights to
Uroplasty, on the terms and conditions contained herein.
NOW THEREFORE, IT IS AGREED AS
FOLLOWS :
1.
Exclusive Manufacturing and Distribution Agreement
.
(a) For five
years beginning on the Effective Date as described in
Section 11 below (the “License Term”), CystoMedix
hereby appoints and grants to Uroplasty, and Uroplasty hereby
accepts from CystoMedix, the exclusive right and license to use,
manufacture, market, sell and distribute the Products during the
term of this Agreement, upon the terms and conditions contained
herein.
(b) The
rights granted to Uroplasty under this Agreement shall extend
throughout the territory of the United States of America, Canada,
and all countries recognizing the medical device CE mark approval
of the European Union, as the same may change from time to time
(the “Territory”).
(c) In
connection with the above rights, CystoMedix hereby grants
Uroplasty during the License Term:
(i) an exclusive
right and license to manufacture, have manufactured, use, sell,
lease or otherwise dispose of Products in the Territory under
CystoMedix’s U.S. Patent Nos. 6,493,588 and 5,711,314, under
U.S. Patent Application Serial Nos. 10/195,197, 10/492,578 and
10/905,501 (and any patents that may issue with respect thereto)
and under any other now existing or hereafter created U.S. or
foreign patent or patent applications owned or controlled by
CystoMedix (all together, the “CystoMedix Patent
Rights”) and
(ii) an exclusive
right and license to make, use, lease, sell or otherwise dispose of
the Products bearing the Trademarks together with all logos and
designs or any other trademark, name or logo which CystoMedix uses
to identify the Products now or hereafter, in the
Territory.
(d) Uroplasty
has the absolute right in its sole discretion to grant one or more
sublicenses to third parties for any or all of the rights granted
to it by CystoMedix under this Agreement.
(e) CystoMedix
agrees that during the License Term, CystoMedix shall not enter
into any arrangement or agreement with any other party for the
manufacture, marketing, sale or distribution of the Products, or
any product which competes with the Products, in the Territory, or
cause or assist in any way in the creation, manufacture, marketing,
sale or distribution of the Products, or any product which competes
with the Products, in the Territory.
(f) Despite
the other provisions of this Agreement, CystoMedix may continue to
serve its existing URGENT-PC customers and new prospects in the
Territory until Uroplasty gives written notice to CystoMedix. Upon
receipt of this notice, CystoMedix will promptly (but in not more
than 10 business days) terminate its business activities in the
Territory and turn over all customer relationships and prospects to
Uroplasty.
2.
Uroplasty’s Responsibilities . During the
License Term, Uroplasty will at its sole cost and
expense:
(a)
Regulatory Compliance . Undertake and manage all
regulatory affairs for the sale and marketing of the Products in
the Territory (such as the FDA 510(k) regulatory approval process
in the United States, the European Medical Device Directives for CE
marking, or Canadian Medical Device Regulations including CMDCAS)
including using its commercially reasonable efforts to obtain and
maintain regulatory and marketing approval for the sale and
marketing of the Products in the Territory, undertaking design
control and clinical testing and clinical trial requirements and
obtaining approval for the use of labeling and promotional
materials for the Products. Uroplasty will also undertake any
testing and documentation necessary to obtain and file for
marketing clearance in the Territory, including compliance with any
applicable quality system regulations for design history. Uroplasty
will exclusively own such testing results and documentation, the
development work related thereto, the regulatory file
-2-
materials and any regulatory and
marketing clearances (including the CE mark and U.S. FDA 510(k)
clearance) it obtains (the “Product Regulatory
Materials”). Uroplasty will list the Products, as finalized
by Uroplasty, with the U.S. FDA and other applicable regulatory
agencies as Uroplasty products.
After the License
Term (but only if the License Term ends upon the natural expiration
of this Agreement and specifically other than on account of
(a) Uroplasty’s exercise of its Option or Right of First
Refusal as described in Section 6 below or (b) a material
breach by CystoMedix), Uroplasty will transfer ownership of the
Product Regulatory Materials relating to the URGENT-PC product (in
the form that such product exists on the date of this Agreement and
not as improved, enhanced or modified hereafter) to
CystoMedix.
(b)
Manufacturing of Products . Establish its own
manufacturing facility (or outsource to a third party) for the
manufacture of the Products according to all regulatory
requirements of the Territory in which the Products will be
distributed (i.e., U.S. FDA Quality System Regulations, European
Medical Device Directives, or Canadian Medical Device Requirements
(CMDCAS)) utilizing the documents provided by CystoMedix pursuant
to Section 3(c) below. Uroplasty will own the manufacturing
processes and documentation it develops and uses for the
Products.
(c)
Marketing . Use its commercially reasonable efforts
to market and sell the Products in the Territory at such prices,
and on such terms, as Uroplasty shall determine in its sole
discretion, and aid CystoMedix in obtaining applicable trademark
registrations for the Trademarks in the Territory.
3.
CystoMedix’s Responsibilities . During the
License Term, CystoMedix will at its sole cost and
expense:
(a)
Regulatory Assistance . Use its commercially
reasonable efforts to assist Uroplasty in obtaining and maintaining
FDA 510(k) marketing clearance in the United States and other
similar and applicable regulatory approval for the marketing and
sale of the Products in the Territory including by sharing (without
cost) all technical files including but not limited to preclinical
testing, design files, clinical, manufacturing, marketing and other
data in CystoMedix’s possession, or otherwise available to it
relating to the Products and regulatory approvals, and by providing
(without cost) sample products for testing.
(b)
Regulatory Compliance . Supply Uroplasty with
(i) any and all worldwide regulatory status changes relative
to the Products market clearances, including any and all worldwide
regulatory agency/Notified Body/consultant correspondence,
(ii) worldwide clinical adverse event experience (including
investigational notes), (iii) assistance as Uroplasty requests
to investigate and resolve Products complaints and/or clinical
adverse events and (iv) update the CystoMedix registration
with the U.S. FDA and the Product device listings to reflect the
provisions of this Agreement. CystoMedix will retain all
responsibility, including regulatory
-3-
responsibility, for clearance,
design, manufacture, distribution, labeling and advertising of any
Products manufactured by it, including prior to the date of this
Agreement.
(c)
Products Design and Manufacturing Specifications .
Deliver to Uroplasty the necessary product design and manufacturing
specifications, as amended, modified or enhanced from time to time,
for the manufacture of the Products (“Products Design and
Manufacturing Specifications”).
(d)
Marketing Assistance . Use its commercially
reasonable efforts to assist Uroplasty in the marketing of the
Products by sharing (without cost) all of CystoMedix’s
current and future marketing materials, including but not limited
to product photographs and graphics, trademark logos and designs,
brochures and website designs, customer lists and leads in the
Territory and other information as reasonably requested by
Uroplasty from time to time.
(e)
CystoMedix Patent Rights . Use its commercially
reasonable efforts to maintain the validity and continuation of the
outstanding CystoMedix Patent Rights, and to prosecute the issuance
of the patent applications that are a part thereof.
(f)
Financial Records . Use its commercially reasonable
efforts to maintain financial and accounting records sufficiently
adequate so as to permit a independent registered public accounting
firm to audit the financial statements of CystoMedix and
subsidiaries as of and for the two years ended, or ending, as of
then most recent CystoMedix fiscal year end (provided, that in no
event shall CystoMedix be required to have financial and accounting
records auditable for its fiscal year ended March 31, 2003 or
earlier). To this end, CystoMedix agrees during the License Term,
and prior to any exercise of Uroplasty’s Option or Right of
First Refusal (as described in Section 6 below), (i) to
retain a third party firm reasonably acceptable to Uroplasty
(Matrix Associates, Inc. is hereby pre-cleared for this purpose) to
assist CystoMedix on a quarterly basis in preparing appropriate
financial statements and maintaining appropriate accounting
procedures and (ii) to retain an independent registered
accounting firm to observe the taking of CystoMedix’s
inventory on the last day of each fiscal year.
4.
Inventory . Within 10 (ten) days following the
Effective Date, deliver to Uroplasty 3/4ths of CystoMedix’s
inventory. This inventory is currently in multiple locations within
The Netherlands and the United States. The parties will equitably
divide the component parts, subassemblies and finished items in a
manner that will reasonably allocate 3/4th of the useful components
and subassemblies (including those that can reasonably be salvaged
from finished goods) for Uroplasty. Uroplasty shall pay CystoMedix
for such inventory the sum of $25,000 in one lump sum payment
payable within ten (10) days following the Effective
Date.
5.
Improved Products . Any improvement, enhancement or
modification to the Products during the License Term, whether made
singly or jointly by either CystoMedix or Uroplasty, their
employees, independent contractors or agents, and whether or not
patentable (all together, “Improved Products”), shall
be owned exclusively by Uroplasty, subject to the following.
Uroplasty will have the exclusive right to determine whether to
seek patent protection for any of
-4-
the Improved Products and will
bear all patent prosecution and patent maintenance charges with
respect to them. During (i) the License Term and
(ii) after the License Term (but only if the License Term ends
upon the natural expiration of this Agreement and specifically
other than on account of (a) Uroplasty’s exercise of its
Option or Right of First Refusal as described in Section 6 below or
(b) a breach by CystoMedix), Uroplasty grants CystoMedix an
exclusive, royalty-free, right and license to manufacture, have
manufactured, use, sell, lease or otherwise dispose of the Improved
Products outside of the Territory. However, in order to give
Uroplasty the opportunity to file for patent protection on the
Improved Products outside of the Territory, CystoMedix must give
Uroplasty at least 90 days prior written notice of
CystoMedix’s intention to market the Improved Products in any
jurisdiction outside of the Territory. Using good faith at all
times, the parties will notify, provide and otherwise cooperate
with each other in all respects regarding the Improved Products
without additional charge under this Agreement. Without limitation,
this includes CystoMedix’s obligation to arrange for
assignment by CystoMedix’s employees to Uroplasty of any
rights to Improved Products.
6.
Option and Right of First Refusal .
(a) CystoMedix
hereby grants Uroplasty the exclusive right and option to acquire
all but not less than all of the assets of CystoMedix (the
“Option”) pursuant to the asset purchase agreement
attached as Exhibit A hereto (the “Asset Purchase
Agreement”). Uroplasty may exercise this Option at any time
beginning on January 1, 2006, but not later than 5:00 p.m.
Central Time on June 30, 2008, by providing an executed copy of the
Asset Purchase Agreement to CystoMedix.
(b) In
addition, if at any time before Uroplasty exercises its Option
(including prior to the date that Uroplasty may first exercise the
Option), CystoMedix receives a bona fide written offer by a third
party, acceptable to CystoMedix, for the “Sale and
Purchase” (as defined below) of CystoMedix (the
“Written Offer”), Uroplasty shall have the first right
and option (the “Right of First Refusal”) to consummate
the transaction described in the Written Offer (at
Uroplasty’s sole election) either (a) on the terms and
conditions described in the Written Offer or (b) pursuant to
the terms of the Asset Purchase Agreement. Upon receipt of the
Written Offer, CystoMedix shall immediately deliver a copy of the
Written Offer to Uroplasty. Uroplasty shall exercise its Right of
First Refusal by giving written notice to CystoMedix within thirty
(30) days of receiving a copy of the Written Offer. In the
event that Uroplasty does not exercise the Right of First Refusal,
CystoMedix may consummate a Sale and Purchase transaction pursuant
to the terms of the Written Offer within 120 days of the date
of the Written Offer; provided, that the purchaser or successor to
CystoMedix or its assets agrees in writing to be bound by the
provisions of this Agreement (including Uroplasty’s Option
rights with respect to the assets or business formerly of
CystoMedix that is purchased or otherwise acquired by the purchaser
or successor pursuant to the Sale and Purchase transaction). If
CystoMedix does not consummate the Sale and Purchase transaction
within such 120-day period, the Right of First Refusal shall
thereafter again apply. The term “Sale and Purchase”
includes one or a combination of (a) a sale of all or
substantially all of the assets of CystoMedix, (b) an
issuance, sale or transfer of CystoMedix’s equity securities
(including securities convertible into equity
securities)
-5-
representing a majority interest
of CystoMedix following the consummation of the transaction,
(c) a merger or consolidation of CystoMedix with or into
another company or entity or (d) other similar extraordinary
corporate transaction.
7.
Royalties . In consideration of the exclusive
manufacturing and distribution rights granted by CystoMedix to
Uroplasty hereunder, Uroplasty shall pay to CystoMedix the
following royalties:
(a) $225,000
is due and payable by Uroplasty on the Effective Date (the
“Initial Royalty Payment”).
(b) $250,000
is payable in twelve equal and successive monthly installments of
$20,833.33 due on each monthly anniversary date of the Effective
Date (the “Scheduled Monthly Royalty
Payments”).
(c) Uroplasty
shall pay CystoMedix 7% of Uroplasty’s “Net Product
Revenues” during the License Term. The term “Net
Product Revenues” means (i) the actual amounts billed
during the License Term by Uroplasty (translated into U.S. dollars
consistent with the manner in which Uroplasty reports its revenues
for SEC reporting purposes) for Uroplasty’s sale of Products
to end users or distributors, or from Uroplasty’s sublicense
of its rights hereunder to manufacture or distribute Products, in
the Territory, less (ii) trade discounts to customers,
refunds, advertising allowances, sales and excise taxes, other
customer allowances or discounts actually given by Uroplasty and
shipping and insurance charges. Royalties are due and payable
quarterly within 45 days after the end of each of Uroplasty’s
fiscal quarters on Net Product Revenues actually received during
the applicable fiscal quarter. Simultaneously with the quarterly
payments, Uroplasty shall deliver to CystoMedix a report of the Net
Product Revenues and the computation of the royalty. Uroplasty
agrees to maintain full and accurate records in sufficient detail
to enable CystoMedix to determine the royalties payable hereunder.
Despite any of the foregoing, royalties computed under this
paragraph (c) shall be offset against (and thus reduced by)
payments of the Scheduled Monthly Royalty Payments.
8.
Product Purchases . During the License Term,
Uroplasty grants CystoMedix the non-exclusive right to purchase,
and Uroplasty agrees to sell, the Products to CystoMedix solely for
sales outside of the Territory at a price, and on terms and
conditions, to be determined by the parties in good faith.
CystoMedix will be responsible for determining the regulatory
clearance requirements, including manufacturing, submissions,
labeling and promotional requirements in the jurisdiction in which
CystoMedix supplies Products.
9.
CystoMedix’s Representations and Warranties .
CystoMedix represents and warrants to Uroplasty that
(i) except as described on the attached Exhibit B
, it is the full and exclusive owner of all right, title and
interest in and to the Products, the Products Design and
Manufacturing Specifications, the CystoMedix Patent Rights and the
Trademarks (collectively the “CystoMedix Intellectual
Property”), (ii) it has the sole and exclusive right to
grant the rights under this Agreement to Uroplasty throughout the
term of the Agreement, (iii) except as
-6-
described on the attached
Exhibit B , CystoMedix has received no notice alleging,
and its executive officers are not aware, that the use of the
CystoMedix Intellectual Property prior to the date hereof, or as
contemplated and provided for herein, infringes or will infringe
any patent, copyright, or other proprietary right of and third
party in any jurisdiction and (iv) the making of this
Agreement does not violate any agreement, right, or other
obligation existing between CystoMedix and any other person, firm,
corporation or entity. In addition, CystoMedix agrees that on or
before the Effective Date, it will arrange for the holders of a
majority of the outstanding shares of CystoMedix’s capital
stock to execute and deliver to Uroplasty the consent to the
transactions contemplated hereby in the form attached as
Exhibit C .
10.
Indemnity .
(a) By
CystoMedix . CystoMedix shall indemnify, protect, defend,
and hold Uroplasty, its sublicensees, parents, subsidiaries, and
affiliates, and the respective officers, directors, shareholders,
agents, and employees of all of the foregoing, harmless from and
against any and all costs, claims, suits, losses, damages,
liabilities, and expenses (including reasonable attorney’s
fees) arising out of or resulting from (i) product, design and
manufacturing defects in the Products as a result of the use of the
Products Design and Manufacturing Specifications by CystoMedix,
(ii) the breach by CystoMedix of any representation, warranty,
covenant or obligation contained in this Agreement, (iii) the
marketing, manufacture, distribution or use of the Products, and
the activities of CystoMedix related thereto, prior to the
Effective Date or (iv) any marketing, manufacture,
distribution or other exploitation of the Products by CystoMedix
outside the Territory.
(b) By
Uroplasty . Uroplasty shall indemnify, protect, defend, and
hold CystoMedix, its parents, subsidiaries, and affiliates, and the
respective officers, directors, shareholders, agents, and employees
of all of the foregoing, harmless from and against any and all
costs, claims, suits, losses, damages, liabilities, and expenses
(including reasonable attorney’s fees) arising out of or
resulting from (i) manufacturing defects in the Products
resulting from other than the use of the Products Design and
Manufacturing Specifications of CystoMedix or (ii) the breach
by Uroplasty of any representation, warranty, covenant or
obligation contained in this Agreement.
11.
Effective Date and Termination . The Effective Date
of the License Term is the date that Uroplasty pays the Initial
Royalty Payment to CystoMedix. In any event, the Effective Date
shall not be later than the earlier of (i) ten days after (and
Uroplasty shall by such date pay the Initial Royalty Payment) the
closing of one or more public or private offerings of
Uroplasty’s securities that, with any other closing on or
after the date hereof, aggregates at least $5,000,000 or
(ii) August 1, 2005.
Despite anything
to the contrary in this Agreement, the License Term and this
Agreement may terminate early as follows:
-7-
(a) by mutual
written agreement of the parties;
(b) by either
party upon written notice to the other of a material breach of this
Agreement, but only if the other party does not cure the breach
within 60 days after receipt of such written
notice;
Upon any
termination, Uroplasty may dispose of all Products in its remaining
inventory in the normal course of business.
12.
Confidentiality .
(a) Each
party agrees to keep confidential all proprietary and confidential
information (written and oral) concerning the other’s
business, financial, operational and acquisition plans and
projections including the terms of this Agreement and the Asset
Purchase Agreement. Each agrees to use this information only to
further this Agreement. Neither party will disclose any of this
information to any person, firm or entity, except on a need-to-know
basis to its respective employees, agents, attorneys and advisors
who agree to maintain the confidentiality of this
information.
(b) CystoMedix
agrees that neither it nor its officers, directors, employees or
agents, or any of their affiliates, will, directly or indirectly,
purchase or sell (whether in a short sale transaction or otherwise)
any of Uroplasty’s Common Stock (or options, warrants or
other rights to purchase or acquire Uroplasty Common Stock) during
the following time periods:
(i) from
this date until the day following the date Uroplasty issues a press
release announcing the terms and conditions of this Agreement,
and
(ii) from
the date Uroplasty exercises the Option or Right of First Refusal
contained in Section 6 until the day following the date
Uroplasty issues a press release announcing either abandonment of
the Option or Right of First Refusal transaction or the
consummation of the Option or Right of First Refusal transaction.
In no event will CystoMedix or any of its officers, directors,
employees or agents, or any of their affiliates, purchase or sell
any of Uroplasty’s securities while in possession of
material, non-public information related to Uroplasty.
(c) A party
is not responsible to keep confidential any information that
(i) is or becomes public other than as a result of acts by or
through such party, (ii) it can demonstrate is already known
by such party at the time of the other’s disclosure,
(iii) it independently obtains from a third party having no
duty of confidentiality to the other, (iv) it independently
develops without using confidential information from the other or
(v) it must disclose pursuant to applicable laws or court
order. CystoMedix acknowledges that Uroplasty will disclose
regulatory and other data of CystoMedix to the FDA in connection
with 510(k) applications and other applicable regulatory
authorities in the Territory and that Uroplasty may file this
Agreement with the U.S. Securities and Exchange Commission as part
of Uroplasty’s periodic filings.
-8-
13.
Miscellaneous .
(a)
Assignment . This Agreement is binding upon, and will
inure to the benefit of, the parties hereof and their respective
permitted successors and assigns. Without limiting the foregoing,
Uroplasty may assign this Agreement to any person, firm or entity
that acquires all or substantially all of Uroplasty’s assets
or acquires Uroplasty by stock acquisition or merger.
(b) No
Amendment or Waiver . No provision of this Agreement will
be deemed waived, amended or modified unless made in writing and
signed by both parties. No waiver of rights shall constitute a
subsequent waiver of any rights whatsoever.
(c)
Entire Agreement . This Agreement contains the entire
understanding of the parties with respect to the subject matter
hereof and shall supersede all proposals and prior agreements and
understandings, oral or written, and any other communications
between the parties regarding this subject matter.
(d)
Severability . If any provision of this Agreement is
determined by a court of competent jurisdiction to be in violation
of any applicable law or otherwise unenforceable or invalid, such
provision will be deemed null and void to such extent as it will be
determined to be illegal, unenforceable or invalid under such law,
but this Agreement will otherwise remain in full force and
effect.
(e)
Relationship of Parties. Uroplasty and CystoMedix are
not partners, venturers, representatives, agents or employees of
each other. Neither party has the authority to act for, represent
or bind the other party in any manner. Neither party shall be
responsible for the debts or liabilities of the other party unless
agreed to in a separate written instrument and no party shall
succeed to the debts or liabilities of the other solely by virtue
of this Agreement.
(f)
Governing Law . This Agreement shall be governed by
Minnesota law excluding its choice of law provision.
IN WITNESS WHEREOF , the undersigned have hereunto affixed
their signatures.
|
|
|
|
|
UROPLASTY, INC
|
|
CYSTOMEDIX,
INC.
|
|
|
|
|
|
By /s/ Sam B.
Humphries
|
|
By /s/ J.
Stephen Schmidt
|
|
|
|
|
|
Its President and
CEO
|
|
Its
Chairman
|
-9-
|
|
|
|
|
ASSET
PURCHASE AGREEMENT
|
|
Exhibit A
|
THIS ASSET PURCHASE AGREEMENT (the “Agreement”)
dated ___, 200___, is by and among Uroplasty, Inc., a Minnesota
corporation (“Uroplasty”), and CystoMedix, Inc., a
Minnesota corporation (“CystoMedix”).
R E C I T A L S :
WHEREAS , Uroplasty manufactures and markets a family of
injectable implant products used for soft-tissue augmentation for
specific indications in urology, urogynecology, gynecology, colon
and rectal, otolaryngology and plastic surgery markets;
WHEREAS , CystoMedix is a medical device company that has
developed products for patients in the urogynecology and gynecology
markets, including neurostimulation devices currently being, or
proposed to be, marketed under the brand names and trademarks
(collectively, the “Trademarks”) URGENT®,
“URGENT-PC™” and “URGENT-SQ™”
(collectively as now existing or hereafter improved, modified or
enhanced, and with any other CystoMedix products, being referred to
hereafter as the “Products”);
WHEREAS , pursuant to an Exclusive Manufacturing and
Distribution Agreement dated April 18, 2005 (the
“License Agreement”), Uroplasty has been acting as the
exclusive manufacturer and distributor of the Products in
particular territories named therein; and
WHEREAS , pursuant to the License Agreement, Uroplasty has
exercised its option or its right of first refusal to acquire all
of CystoMedix’s assets on the terms and conditions of this
Agreement;
NOW THEREFORE, IT IS AGREED AS FOLLOWS :
SECTION 1. DEFINITIONS
Unless otherwise
defined elsewhere in this Agreement, as used in this Agreement and
any exhibits or schedules hereto, the following words and phrases
shall have the meanings set forth below:
“Act”
shall mean the Securities Act of 1933, as amended.
“Authorization”
and “Authorizations” shall have the meanings ascribed
to them in Section 5.23 below.
“Base
Balance Sheet” shall have the meaning ascribed to it in
Section 5.4 below.
“Closing”
shall mean the consummation of the transactions contemplated herein
as described in Section 4.1 below.
“Closing
Date” shall be the date of the Closing as described in
Section 4.1 below.
“Code”
shall mean the Internal Revenue Code of 1986, as amended and
interpreted by treasury regulations.
“Uroplasty
Common Stock” shall mean the Common Stock of Uroplasty, par
value $.01 per share.
“Employee
Benefit Plans” shall have the meaning ascribed to it in
Section 5.25(a) below.
“Environmental
Law” shall mean any environmental or health and
safety-related law, regulation, rule, ordinance, or by-law at the
federal, foreign, state, or local level, whether existing as of the
date hereof, previously enforced or subsequently
enacted.
“ERISA”
shall mean the Employee Retirement Income Security Act of 1974, as
amended.
“Escrow
Agent” shall be a bank or trust company selected by
Uroplasty, unless otherwise agreed to by the parties.
“Escrow
Agreement” shall mean the Escrow Agreement by and among
Uroplasty, CystoMedix and the Escrow Agent.
“Exchange
Act” shall mean the Securities Exchange Act of 1934, as
amended.
“Financial
Statements” shall have the meaning ascribed to it in
Section 5.4 below.
“Fraud”
shall require a showing of an intent to deceive and, with respect
to a claim of misrepresentation, that the party to be charged had
Knowledge of the falsity of the representation (or acted recklessly
in making the representation); and with respect to an omission,
that the party to be charged Knowingly failed to disclose (or acted
recklessly in failing to disclose).
“Hazardous
Materials” shall mean and include any hazardous waste,
hazardous material, hazardous substance, petroleum product, oil
toxic substance or pollutant as defined in or pursuant to the
Resource Conservation and Recovery Act, as amended, the
Comprehensive Environmental Response, Compensation and Liability
Act, as amended, the Hazardous Materials Transportation Act or any
other foreign, federal, state or local law, regulation, ordinance,
rule or by-law, whether existing as of the date hereof, previously
enforced or subsequently enacted pertaining to environmental or
health and safety matters.
“Intellectual
Property” shall have the meaning ascribed to it in
Section 5.13(a) below.
-2-
“Knowledge”
shall mean actual knowledge after reasonable investigation by the
individual or the entity referred to.
“Person”
shall mean an individual, a partnership, a corporation, an
association, a joint stock company, a trust, a joint venture, an
unincorporated organization or a governmental entity (or any
department, agency or political subdivision thereof).
“Purchase
Consideration” shall have the meaning ascribed to it in
Section 3.1 below.
“Qualified
Plan” shall have the meaning ascribed to it in
Section 5.25(b) below.
“SEC”
shall mean the U.S. Securities and Exchange Commission.
“Taxes”
shall mean any federal, state, local or foreign income, gross
receipts, license, payroll, employment, excise, severance, stamp,
occupation, premium, windfall profits, environmental, customs
duties, capital stock, franchise, profits, withholding, social
security (or similar), unemployment, disability, real property,
personal property, sales, use, transfer, registration, value-added,
alternative or add-on minimum, estimated or other tax of any kind
whatsoever, including any interest, penalty or addition thereto,
whether disputed or not.
“Tax
Return” shall mean any return, declaration, report, claim for
refund or information return or statement relating to Taxes,
including any schedule or attachment thereto, and including any
amendment thereof.
SECTION 2. SALE OF ASSETS
2.1
Sale of Assets by CystoMedix . Subject to the terms and
conditions set forth in this Agreement, at the Closing, CystoMedix
will sell, convey, transfer, assign and deliver to Uroplasty (or to
a subsidiary of Uroplasty, if so designated by Uroplasty, referred
to hereafter as the “Acquisition Subsidiary”), and
Uroplasty (or its Acquisition Subsidiary) will purchase from
CystoMedix, the exclusive right, title and interest, free and clear
of all liens, security interests and encumbrances, in and to all of
CystoMedix’s assets, whether personal, intangible,
intellectual or otherwise (collectively, the “Assets”),
except as specifically excluded in this Section 2.1,
including, without limitation, the following:
(a) Cash
and Accounts Receivable . Any and all cash and bank accounts
and all investments, investment accounts or other similar holdings,
all accounts receivable and all credit balances, reimbursements or
rebates arising prior to the Closing, but excluding any payments
made or to be made by Uroplasty to CystoMedix pursuant to the
License Agreement (such payments being part of the “Excluded
Assets”).
(b)
Tangible Assets . All of CystoMedix’s physical assets
utilized by or useful to it including, but not limited to,
furniture, fixtures, equipment, machinery, hardware, office
equipment, tools, supplies, inventories and any other tangible
personal property or assets used or
-3-
usable by
CystoMedix in the operation of its business wherever located
(including products on evaluation with customers or potential
customers), together with any replacements and additions made
between the date of this Agreement and the Closing.
(c)
Contracts and Agreements . All contracts and agreements of
CystoMedix, including the confidentiality and noncompetition
agreements between CystoMedix and each of the Transferred Employees
and any other employee of CystoMedix hired by Uroplasty on or after
the Closing Date and any renewals, extensions, amendments or
modifications thereof (all together, the “Assigned
Contracts”).
(d)
Intangible Assets . All patents, copyrights, trademark and
service marks, tradenames including “CystoMedix,” the
domain name “cystomedix.com,” licenses, computer
software, code, trade secrets, business plans, rights, governmental
permits, licenses, approvals or authorizations, CystoMedix’s
telephone numbers and other intangible property rights and
interests applied for, issued to or owned in whole or in part by
CystoMedix, or under which CystoMedix is licensed. Without
limitation, the purchased assets include U.S. Patent Nos. 6,493,588
and 5,711,314, U.S. Patent Application Serial Nos. 10/195,197,
10/492,578 and 10/905,501 (and any patents that may issue with
respect thereto) and any other U.S. or foreign patent or patent
applications owned or controlled by CystoMedix (all together, the
“CystoMedix Patent Rights”).
(e)
Regulatory Assets . CystoMedix’s FDA 510(k) and
foreign marketing clearances or registrations for Products,
including, without limitation, all technical and design files
related to preclinical testing, design, clinical, manufacturing,
marketing, distribution, labeling, advertising, clinical adverse
event experience (including investigational notes) and other
regulatory matters, and any and all worldwide regulatory
agency/Notified Body/consultant correspondence.
(f)
Product Design and Manufacturing Specifications . All
product design and manufacturing specifications, as amended,
modified or enhanced from time to time, for the manufacture of the
Products (the “Products Design and Manufacturing
Specifications”).
(g)
Marketing Materials . All marketing materials, including but
not limited to product photographs and graphics, trademark logos
and designs, brochures and website designs.
(h)
Goodwill . CystoMedix as a going concern, and any and all of
its goodwill.
(i)
Customers . Any and all of CystoMedix’s past and
present customer lists, prospect and prospect lists and
relationships with customers and suppliers.
(j)
Business Records . All files, logs, records, books of
account, financial records, supplier files and lists, including
telephone numbers, payroll and personnel records, marketing data
and reports, marketing information, brochures, art work,
photographs, advertising materials, consultants’ reports,
design drawings and other similar or related materials, but
excluding CystoMedix’s corporate records and minute books
(such latter materials also being part of the “Excluded
Assets”).
-4-
2.2
Assumption of Liabilities . Uroplasty (and its Acquisition
Subsidiary, if applicable) shall not assume and Uroplasty (and its
Acquisition Subsidiary, if applicable) shall not be liable for any
of the obligations or liabilities of CystoMedix or for obligations
related to the Assets of any kind or nature other than obligations
or liabilities:
(a) arising
in the ordinary course of business that are associated with the
Assets (but not the Excluded Assets); provided, however, that
Uroplasty (and its Acquisition Subsidiary, if applicable) will not
assume any obligations for accrued, but unpaid, regular, bonus or
back compensation, vacation pay, severance pay or other similar
amounts payable to employees of CystoMedix;
(b) arising
under or related to any of the Assets after the Closing Date which
Uroplasty agrees to specifically assume at Closing;
(c) arising
under those real property leases of CystoMedix which Uroplasty may
desire to assume and which are assigned and assumed pursuant to an
agreement satisfactory to the parties to be executed and delivered
at Closing; and
(d) up to
$1,400,000 of loans payable to Mr. J. Stephen Schmidt,
Chairman of CystoMedix or his affiliates (“Schmidt”),
incurred by CystoMedix prior to the date of the License Agreement
(the “Bridge Loan”).
2.4
Right of Inspection . From the date hereof and until
Closing, CystoMedix will make available at reasonable times
CystoMedix’s books, records and other financial statements
and information as are requested by Uroplasty for examination, and
for the examination by its advisors and such other information
relating to the Assets as Uroplasty may reasonably
request.
SECTION 3. PURCHASE
CONSIDERATION
3.1
Purchase Consideration . As full payment for the transfer of
the Assets under Section 2.1 by CystoMedix to Uroplasty,
Uroplasty agrees to pay CystoMedix the sum of the following (the
“Purchase Consideration”):
(a)
Uroplasty Common Stock . In exchange for CystoMedix’s
assets, on the Closing Date, Uroplasty will issue to CystoMedix
that number of shares of Uroplasty’s Common Stock equal to
the following formula (the “Shares”):
|
|
$3,485,000 divided by the Share
Price, less a number of shares computed by dividing
(x) the dollar amount of CystoMedix liabilities relating to
accounting expenses paid by Uroplasty prior to the Closing Date
(but excluding the first $50,000 of accounting expenses of or for
the benefit of CystoMedix paid or incurred by Uroplasty prior to or
after the date of this Agreement) by (y) the Share Price. In
no event will the accounting expense deduction in this formula
(after exclusion of the $50,000 basket amount) exceed
$50,000.
|
-5-
The
term “Share Price” means the average of the high
closing bid price of Uroplasty’s Common Stock, as quoted on
the OTC Bulletin Board, during the 20 trading days prior to the
Closing Date. All share computations shall be rounded to the
nearest whole share.
Despite the above,
in computing the number of Shares issuable to CystoMedix, the
$3,485,000 amount above shall increase at a rate of 10% per year
(not co
|