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
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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
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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
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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)
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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
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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:
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(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.
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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.
| |
|
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| UROPLASTY, INC |
|
CYSTOMEDIX, INC. |
| |
|
|
| By /s/ Sam B.
Humphries |
|
By /s/ J. Stephen Schmidt |
| |
|
|
| Its President and
CEO |
|
Its Chairman |
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|
|
|
| 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.
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“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
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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”).
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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”):
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$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. |
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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 compounded),
commencing from the date that is two years after the date of the
License Agreement, until Uroplasty exercises its Option or Right of
First Refusal under the License Agreement.
(b) Sales and Use Taxes
. CystoMedix shall pay any sales, use or oth
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