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EXHIBIT 10.1
PARTNERSHIP INTEREST PURCHASE AGREEMENT
THIS PARTNERSHIP INTEREST PURCHASE AGREEMENT (this "AGREEMENT") is made as
of the 30th day of December, 2004, by and between Endocare, Inc., a Delaware
corporation (the "SELLER") and Advanced Medical Partners, Inc., a Delaware
corporation (the "BUYER").
WITNESSETH
WHEREAS, the Seller owns, manages, and operates certain entities that own
medical devices and other equipment which provide cryosurgical therapy for
prostate cancer (the "BUSINESS"); and
WHEREAS, the Seller desires to sell, assign and transfer to the Buyer, and
the Buyer desires to purchase from the Seller, the Seller's general partnership
interests, limited partnership interests and other equity and ownership
interests of any kind or nature in the partnerships described herein; and
WHEREAS, the parties wish to set forth their agreement with respect to the
purchase and sale of the Interests (as defined in Section 1.1(B) below) and
other matters.
NOW THEREFORE, in consideration of the foregoing and the mutual covenants
and promises herein contained, the parties agree as follows:
1. PURCHASE, SALE, AND ASSIGNMENT OF THE INTERESTS.
1.1 PURCHASE, SALE AND ASSIGNMENT.
(A) Subject to the terms and conditions hereof, at the Initial
Closing (as defined in Section 1.4 hereof) the Seller shall sell, assign, convey
and otherwise transfer to the Buyer, and the Buyer shall purchase from the
Seller, all right, title and interest of Seller in and to (i) each limited
partnership and other ownership or equity interest (including, without
limitation, each option or other right to purchase or acquire any such limited
partnership and other ownership or equity interest) as set forth and described
on Schedule 1.1 hereto (collectively, the "INITIAL INTERESTS"), in the
partnerships or that constitute a portion of the Business as listed on Schedule
1.1 hereto (collectively, the "PARTNERSHIPS"), (ii) a ninety-nine percent (99%)
interest in each general partnership interest and each option or other right to
purchase or acquire any such general partnership interest, as set forth and
described in Schedule 1.1, in the Partnerships ("FIRST TRANCHE GP INTERESTS,"
the Initial Interests and the First Tranche GP Interests are collectively
referred to herein as the "FIRST TRANCHE INTERESTS"), (iii) any management
agreements or other similar agreements between Seller and/or its affiliates, on
the one hand, and any of the Partnerships, on the other hand (the "MANAGEMENT
AGREEMENTS"); (iv) any rights of Seller and/or any of Seller's products in any
territory ("DISTRIBUTION RIGHTS"); and (v) 1,134,922 shares of Class A Common
Stock (the "U.S.M.D. INTEREST") of U.S. Medical Development, Inc., a Nevada
corporation ("U.S.M.D."), in each case, free and clear of any and all security
interests, liens, charges, claims, agreements (other than the obligations of
Buyer under the Partnership Agreements from and after the Initial Closing),
obligations and encumbrances of any nature whatsoever (as defined in Section
2.2) ("ENCUMBRANCES").
(B) Subject to the terms and conditions hereof, at the Second
Closing (as defined in Section 1.4 hereof) the Seller shall sell, assign, convey
and otherwise transfer to Buyer, and the Buyer shall purchase from the Seller,
all right, title and interest of Seller in and to the Seller's then remaining
one percent (1%) interests in each general partnership interest of the Seller,
as set forth and described in Schedule 1.1, in the Partnerships (the "SECOND
TRANCHE GP INTERESTS"; the First Tranche Interests and the
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Second Tranche GP Interests are collectively referred to herein as the
"INTERESTS"), free and clear of any and all Encumbrances.
(C) The Seller and Buyer hereby expressly acknowledge and
agree that Buyer is purchasing and Seller is selling at and as of the Initial
Closing, with respect to the First Tranche Interests and at and as of the Second
Closing, with respect to the Second Tranche GP Interests, each and every
economic and financial interest of Seller in and to the Partnerships, including
without limitation, the right to receive distributions under the Partnership
Organizational Documents (as defined in Section 2.2 below). Without limiting the
generality of the foregoing, if and to the extent that the transfer of any of
the Interests hereunder or the consummation of any of the Transactions is deemed
to have been a transfer that is not a "Permitted Transfer" (as such term is
defined in the Partnership Agreements) under any of the Partnership Agreements,
the Seller, as general partner for each Partnership for which such Seller is a
general partner, in accordance with Section 10.03 of each of the Partnership
Agreements, hereby elects to recognize such transfer notwithstanding that such
transfer may be deemed to not be a "Permitted Transfer."
1.2 PURCHASE PRICE. In consideration of the sale, assignment and
transfer of the Interests pursuant to Section 1.1 hereof, the Buyer agrees to
pay to Seller, within twenty (20) days of the Second Closing Date (the
"CONSIDERATION DATE"), the sum of $850,000 (the "CONSIDERATION") by wire
transfer of immediately available funds to an account designated by the Seller.
1.3 NO ASSUMPTION OF LIABILITY. Except as expressly provided in this
Agreement, neither party shall assume or shall be deemed to have assumed any
liability or obligation of any other party of any kind, character, or
description, whether known or unknown, absolute or contingent, accrued or
unaccrued, disputed or undisputed, liquidated or unliquidated, secured or
unsecured, joint or several, due or to become due, vested or unvested,
executory, determined, determinable or otherwise (a "LIABILITY").
1.4 CLOSING.
(A) INITIAL CLOSING. The initial closing of the transactions
contemplated hereby, other than the transactions contemplated by Section 1.1(B)
hereof, (the "INITIAL CLOSING") shall be held on December 30, 2004 (the "INITIAL
CLOSING DATE"), at the offices of Haynes and Boone, LLP, 201 Main Street, Suite
2200, Fort Worth, Texas 76102, or at such other location as the Buyer shall
designate.
(B) SECOND CLOSING. The closing of the transactions
contemplated by Section 1.1(B) hereof (the "SECOND CLOSING"; the Initial Closing
and the Second Closing are sometimes collectively referred to herein as the
"CLOSINGS") shall be held on December 31, 2004 (the "SECOND CLOSING DATE") at
the offices of Haynes and Boone, LLP, 201 Main Street, Suite 2200, Fort Worth,
Texas 76102, or at such other location as the Buyer shall designate. The parties
agree that the effective date of the transactions contemplated by this
Agreement, for accounting and employment purposes, shall be the Second Closing
Date.
(C) TRANSACTIONS. For purposes of this Agreement,
"TRANSACTIONS" shall mean any and all of the transactions contemplated by this
Agreement.
2. REPRESENTATIONS AND WARRANTIES OF SELLER.
The Seller, on its own behalf and on behalf of the Partnerships, as
applicable, represents and warrants to the Buyer, as follows, as of the date
hereof, except as set forth on the disclosure schedule furnished to Buyer and
attached hereto which sets for the exceptions to the representations and
warranties
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contained in this Section 2 and certain other information called for by this
Section 2 (the "SELLER DISCLOSURE SCHEDULE") which Seller Disclosure Schedule
identifies any such exceptions with reasonable particularity and is arranged in
sections corresponding to the numbered and lettered sections contained in this
Agreement. The parties acknowledge and agree that disclosure of any fact or item
in any particular section of the Seller Disclosure Schedule shall be deemed to
be made in any other specific section or sections of the Seller Disclosure
Schedule to which such disclosure reasonably relates.
2.1 AUTHORITY. The Seller possesses full corporate power and
authority to execute and deliver this Agreement and to consummate the
Transactions. This Agreement has been duly and validly executed and delivered by
the Seller and constitutes the legal, valid and binding obligation of the
Seller, enforceable against it in accordance with its terms, except as such
enforceability may be limited by bankruptcy, insolvency or other similar laws
from time to time in effect which affect the enforcement of creditors' rights
generally and by general principles of equity.
2.2 NO VIOLATION. The execution and delivery of this Agreement by
the Seller and the performance by it of the Transactions will not (A) violate
any provision of the Partnership Organizational Documents, (B) violate any law
or regulation of any United States federal, territorial, state or local
governmental or regulatory agency or authority (an "AUTHORITY"), (C) require any
consent or approval of, notice to or filing with any Authority which has not
been obtained or made, except where the failure to obtain such consent or
approval, or to provide such notice or filing, would not have a Material Adverse
Effect (as defined below) on the Partnerships, (D) result in a breach of any
provision of, or require the consent or approval of any third party which has
not been obtained under any material contract or agreement to which the Seller
or any of the Partnerships is a party, or (E) result in the creation or
imposition of any Encumbrance upon any portion of the assets of the Partnerships
pursuant to the terms of any contract or agreement to which the Seller or any of
the Partnerships is a party (the consents, approvals and notices, if any,
required to be obtained or made and referred to in clauses (C) and (D) above are
collectively referred to herein as "PARTNERSHIP CONSENTS"). Seller has
heretofore delivered to the Buyer true, correct and complete copies of (X) the
certificates of limited partnership of the Partnerships and all amendments
thereto (collectively, the "PARTNERSHIP CERTIFICATES"), (Y) the limited
partnership agreements of the Partnerships and all amendments thereto
(collectively, the "PARTNERSHIP AGREEMENTS"), and (Z) all other organizational
documents, if any, of the Partnerships governing the ownership, operation,
voting and control of any of the Partnerships (the documents described in
clauses (X), (Y) and (Z) above are, collectively referred to herein as the
"PARTNERSHIP ORGANIZATIONAL DOCUMENTS").
2.3 TITLE TO THE INTERESTS.
(A) The list of the Partnerships set forth in Schedule 1.1
hereto is a true, correct and complete list of each partnership through which
the Business (or any portion thereof) is conducted by the Seller.
(B) The list of the Interests set forth and described in
Schedule 1.1 hereto is a true, correct and complete list of each general
partnership, limited partnership and other ownership or equity interest
(including, without limitation each option or other right to purchase or acquire
any such general partnership, limited partnership and other ownership or equity
interest), of the Partnerships owned beneficially or of record by the Seller.
(C) The Seller is the record and beneficial owner of and has
good and valid title to the Interests in the percentages set forth in Schedule
1.1, free and clear of any and all Encumbrances.
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(D) The delivery by the Seller of the Interests to the Buyer
at the Initial Closing or the Second Closing, as provided herein, shall convey
to the Buyer good and valid title to the Interests, free and clear of all, and
shall not result in Buyer being subject to any, Encumbrances.
(E) During the Ownership Period (as defined in Section 9.10
below), each of the issued and outstanding general partnership, limited
partnership and other equity ownership interests (including, without limitation,
each option or other right to purchase or acquire any such general partnership,
limited partnership and other equity ownership interests), in the Partnerships,
including, without limitation, the Interests, has been issued in full compliance
with the Partnership Organizational Documents applicable thereto and in full
compliance with all applicable securities laws, rules, regulations and
requirements. Each subsequent transfer during the Ownership Period, if any, of
any such general partner interests (including the First Tranche GP Interests and
the Second Tranche GP Interests), was made in full compliance with the
Partnership Organizational Documents applicable thereto and, in full compliance
with all applicable securities laws, rules, regulations and requirements.
(F) The Seller has made any and all capital contributions
required to be made by it during the Ownership Period (including, without
limitation, any required initial capital contributions) to the Partnerships as
required by the Partnership Organizational Documents. The Seller has no
obligation to make any other capital contribution or any loan or other payment
or any other transfer of assets or services to the Partnerships.
2.4 OTHER OWNERSHIP INTERESTS. During the Ownership Period, no other
person has any right to obtain or acquire any general partnership, limited
partnership or other ownership or equity interest (including, without
limitation, any option or other right to purchase or acquire any such general
partnership, limited partnership or other ownership or equity interest), in or
to any of the Partnerships or its capital, profits or distributions.
2.5 CONTRACTS AND COMMITMENTS.
(A) CONTRACTS. Set forth in Section 2.5 of the Seller
Disclosure Schedule is a true, correct and complete list of each of the
following agreements, whether written or oral, to which the Partnerships (or any
of them) is a party:
(1) any lease of real property, or legally binding
commitment, contract, obligation or agreement for the purchase or sale of real
property (hereinafter, legally binding commitments, contracts, obligations and
agreements of any nature shall all be included in the term "AGREEMENT");
(2) any employment agreement with any officer, employee,
director or consultant which is not terminable without severance liability in
excess of $50,000.00 at the discretion of such Partnership on thirty (or fewer)
days' notice from such Partnership;
(3) any agreement to lend or borrow money in excess of
$50,000;
(4) any collective bargaining agreement with any labor
union or other representative of employees;
(5) any agreement guaranteeing the payment or
performance of the obligations of others, except in the ordinary course of
business;
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(6) any lease of any personal property under the express
terms of which such Partnership shall hereafter be obligated to make aggregate
annual payments exceeding one hundred thousand dollars ($100,000.00);
(7) any ongoing agreement for the sale or purchase of
products or services by such Partnership under the terms of which such
Partnership could hereafter be entitled to receive or obligated to make
aggregate annual payments exceeding one hundred thousand dollars ($100,000.00)
for any such agreement;
(8) any partnership or joint venture agreement the
existence of which the Seller has not informed the limited partners of the
Partnerships;
(9) any security or pledge agreement;
(10) any management or similar agreement, or
(11) any amendments Partnership Organizational Documents
made during the Ownership Period;
(12) any agreement (written or oral) pursuant to which
the Seller has granted to any person the exclusive right to conduct procedures
provided by the Partnerships; and
(13) any other agreement material to any of the
Partnerships.
(B) ENFORCEABILITY AND ASSIGNABILITY. Each of the agreements
set forth in Section 2.5 of the Seller Disclosure Schedule and the requirements
relating to the indebtedness referenced in Section 2.6 (the "CONTRACTS") is
enforceable and in full force and effect, except as such enforceability and
effectiveness may be limited by bankruptcy, insolvency or other similar laws
from time to time in effect which affect the enforcement of creditors rights
generally and by general principles of equity; and none of the Partnerships is
in breach or default, nor are there any facts that with notice or lapse of time
would cause a breach or default by the Partnerships under any of the Contracts,
nor is the Seller aware of any existing breach or default or of any facts that
with notice or lapse of time would constitute a breach or default of any such
Contract by any other party thereto. Each of the written Contracts incorporates
all of the material terms and conditions agreed to by the parties thereto. The
consummation of the Transactions will not be deemed to be an assignment of any
of the Contracts requiring the consent of any other person.
2.6 INDEBTEDNESS OF THE PARTNERSHIPS. None of the Partnerships has,
during the Ownership Period, nor shall the consummation of the Transactions
result in any of the Partnerships being subject to, any debt, guaranty,
liability or obligation of any nature, whether accrued, absolute, contingent or
otherwise, due or to become due, or known or unknown, other than such
liabilities incurred in the ordinary course of business consistent with past
practices or which have not had or could not reasonably be expected to result in
a Material Adverse Effect on the Partnerships.
2.7 LITIGATION. Except as disclosed in the Seller SEC Reports (as
defined in Section 9.10 below) filed prior to the date hereof, there is no suit,
action or other proceeding, or injunction or final judgment relating thereto,
pending, or to the knowledge of the Seller, threatened (i) against either the
Seller or the Partnerships, nor, to the knowledge of the Seller, any
investigation that might result in any such suit, action or proceeding, (ii)
that, to the knowledge of the Seller, otherwise relates to or may affect the
Business or (iii) that challenges, or that may have the effect of preventing,
delaying, making illegal or otherwise interfering with, any of the Transactions.
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2.8 ABSENCE OF CHANGES. During the Ownership Period, except for (i)
the execution and delivery of this Agreement and the Transactions and (ii) as
disclosed in the Seller SEC Reports filed prior to the date hereof, there has
not been any event or development which could reasonably be expected to result
in a Material Adverse Effect (as hereafter defined) on the Partnerships. For
purposes of this Agreement, "MATERIAL ADVERSE EFFECT" means, for any person, a
material adverse effect (a) on the business, operations, financial condition,
assets and properties, liabilities or prospects of such person, taken as a
whole, or (b) on the ability of such person to consummate the Transactions,
provided, however, that it shall not include any of the following, either alone
or in combination any effect or change occurring as a result of (i) general
economic or financial conditions, or (ii) other developments which are not
unique to the person but also uniformly affect each of the other persons who
participate or are engaged in the lines of business in which the person
participates or is engaged.
2.9 TANGIBLE PERSONAL PROPERTY. All tangible personal property and
equipment used by the Partnerships in the conduct of the Business is listed in
Section 2.9 of the Seller Disclosure Schedule (the property and equipment listed
in such section is referred to herein as the "PARTNERSHIPS EQUIPMENT"). Each of
the Partnerships is in possession of and has good title to the Partnerships
Equipment, except where the failure to hold such title, interest or right would
not have a Material Adverse Effect either individually or in the aggregate on
the Partnerships (or any of them).
2.10 COMPLIANCE WITH LEGAL REQUIREMENTS; GOVERNMENTAL
AUTHORIZATIONS. Except as otherwise disclosed in the Seller SEC Reports filed
prior to the date hereof, during the Ownership Period:
(A) Both the Seller (with respect to the conduct and
operations of the Business) and the Partnerships are, and have been during the
Ownership Period, in compliance with each legal requirement that is or was
applicable to it or to the conduct or operation of the Business or the ownership
or use of any of its assets, except where failure to comply would not result in
a Material Adverse Effect.
(B) No event has occurred or circumstance exists during the
Ownership Period that (with or without notice or lapse of time) (i) may
constitute or result in a violation by the Seller and the Partnerships (or any
of them) of any legal requirement with respect to the conduct and operation of
the Business, except where such violation would not result in a Material Adverse
Effect on the Partnerships (or any of them) or (ii) may give rise to any
obligation on the part of the Seller and the Partnerships (or any of them) to
undertake, or to bear all or any portion of the cost of, any remedial action of
any nature with repect to the conduct or operations of Business, except where
the cost of such remedial action would not have a Material Adverse Effect.
(C) Neither the Seller nor the Partnerships has received any
written notice or other written communication from any Authority or any other
person during the Ownership Period regarding (i) any actual, alleged, possible,
or potential violation of, or failure to comply with, any legal requirement with
respect to the conduct and operation of the Business, or (ii) any actual,
alleged, possible, or potential obligation on the part of the Seller and the
Partnerships (or any of them) to undertake, or to bear all or any portion of the
cost of, any remedial action of any nature with respect to the conduct and
operation of the Business.
2.11 ENVIRONMENTAL MATTERS. Except as otherwise disclosed in the
Seller SEC Reports filed prior to the date hereof:
(A) Each of the Partnerships is in compliance with all
applicable Environmental Laws (as defined below) except where such failure could
not reasonably be expected to have a Material Adverse Effect, and there are no
circumstances which may materially prevent or interfere with such
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compliance in the future. Neither the Seller nor the Partnerships have received
during the Ownership Period any communication (whether written or oral), whether
from an Authority, citizen group, employee or otherwise, that alleges that the
Partnerships (or any of them) or any of their respective assets or properties
used in the Business is not in full compliance with Environmental Laws. All
permits, registrations and other governmental authorizations currently held by
the Seller and the Partnerships (or any of them) pursuant to Environmental Laws
(collectively, "ENVIRONMENTAL PERMITS") represent all permits necessary for the
conduct of the Business as currently conducted, except where the failure to hold
such Environmental Permits (or any of them) could reasonably be expected to have
a Material Adverse Effect. Neither the Seller nor the Partnerships has been
notified by any relevant Authority during the Ownership Period that any permit
will be modified, suspended or revoked or cannot be renewed in the ordinary
course of business.
(B) There is no Environmental Notice (as defined below) that
is (i) pending or, to the knowledge of the Seller, threatened against any of the
Partnerships or (ii) to the knowledge of the Seller, pending or threatened
against any person whose liability for such Environmental Notice may have been
retained or assumed by or could reasonably be imputed or attributed to the
Seller and the Partnerships (or any of them).
(C) To the knowledge of the Seller, there are no past or
present actions, activities, circumstances, conditions, events or incidents
arising from the operation, ownership or use of any property currently or
formerly owned, operated or used by the Partnerships during the Ownership
Period, including, without limitation, the release, emission, discharge or
disposal of any Material (as defined below) into the Environment (as defined
below), that (i) could reasonably be expected to result in the incurrence of
costs under Environmental Laws or (ii) could reasonably be expected to form the
basis of any Environmental Notice against or with respect to the Partnerships or
against any person whose liability for any Environmental Notice may have been
retained or assumed by or could be imputed or attributed to the Seller and the
Partnerships (or any of them).
(D) For purposes of this Section 2.11:
(1) "ENVIRONMENT" means any surface water, ground water,
drinking water supply, land surface or subsurface strata, ambient air and any
indoor workplace.
(2) "ENVIRONMENTAL NOTICE" means any written notice by
any person alleging potential liability (including, without limitation,
potential liability for investigatory costs, cleanup costs, governmental costs,
harm or damages to person, property, natural resources or other fines or
penalties) arising out of, based on or resulting from (a) the emission,
discharge, disposal, release or threatened release in or into the Environment of
any Material or (b) circumstances forming the basis of any violation, or alleged
violation, of any applicable Environmental Law.
(3) "ENVIRONMENTAL LAWS" means all national, state,
local and foreign laws, codes, regulations, common law, requirements,
directives, orders, and administrative or judicial interpretations thereof, all
as in effect on the date hereof or on the Initial Closing Date, that may be
enforced by any Authority, relating to pollution, the protection of the
Environment.
(4) "MATERIAL" means pollutants, contaminants or
chemical, industrial, hazardous or toxic materials or wastes, including, without
limitation, petroleum and petroleum products.
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2.12 TAX MATTERS.
(A) Each of the Partnerships has filed on a timely basis during
the Ownership Period all Tax Returns (as defined below) that it was required to
file, and all such Tax Returns were complete and accurate in all material
respects. Each Partnership has paid on a timely basis all Taxes that were due
and payable during the Ownership Period, or if not yet due and payable, such
Taxes are accrued on the books and records of the Partnerships. None of the
Partnerships has any actual or potential liability for any Tax obligation of any
other taxpayer (including any affiliated group of entities that included the
Partnerships. All Taxes that the Partnerships are or were required by law to
withhold or collect during the Ownership Period have been duly withheld or
collected and, to the extent required, have been paid to the proper Authority.
(B) Seller has made available to Buyer complete and accurate
copies of all federal income Tax Returns with repect to the Ownership Period,
and has delivered to Buyer complete and accurate copies of all examination
reports and statements of deficiencies, if any, assessed against or agreed to by
the Partnerships during the Ownership Period. Seller has delivered to Buyer or
made available to Buyer complete and accurate copies of all other Tax Returns of
the Seller and the Partnerships, together with all related examination reports
and statements of deficiency during the Ownership Period. To the knowledge of
the Seller, no examination or audit of any Tax Return of the Partnerships by any
Authority is currently in progress or, threatened or contemplated. Neither the
Seller nor the Partnerships has been informed in writing by any jurisdiction
during the Ownership Period that the jurisdiction believes that the Partnerships
(or any of them) were required to file any Tax Return that was not filed. The
Partnerships have not, during the Ownership Period, waived any statute of
limitations with respect to Taxes or agreed to an extension of time with respect
to a Tax assessment or deficiency.
(C) For purposes of this Agreement:
(1) "TAX" (and, with correlative meaning, "TAXES,"
"TAXABLE" and "TAXING") means (i) any federal, state, local or foreign income,
alternative or add-on minimum tax, gross income, gross receipts, sales, use, ad
valorem, transfer, franchise, profits, license, withholding, payroll,
employment, excise, severance, stamp, occupation, premium, property,
environmental or windfall profit tax, custom, duty or other tax, governmental
fee or other like assessment or charge of any kind whatsoever, together with any
interest or any penalty, addition to tax or additional amount imposed by any
Authority responsible for the imposition of any such tax (domestic or foreign),
(ii) any liability for payment of any amounts of the type described in (i) as a
result of being a member of an affiliated, consolidated, combined, unitary or
other group for any Taxable period and (iii) any liability for the payment of
any amounts of the type described in (i) or (ii) as a result of any express
obligation to indemnify any other person.
(2) "TAX RETURN" means any return, report, information
return, schedule or other document (including any related or supporting
information) filed or required to be filed with respect to any taxing authority
with respect to Taxes.
2.13 PERMITS. All permits used in and material, individually, or in
the aggregate, to the Partnerships for the conduct of the Business during the
Ownership Period are currently effective and valid and have been validly issued.
Upon written request, the Seller shall provide the Buyer a list of such permits.
To the knowledge of Seller and the Partnerships, no additional permits are
necessary to enable the Partnerships (or any of them) to conduct the Business in
material compliance with all applicable federal, state and local laws. Neither
the execution, delivery or performance of this Agreement nor the mere passage of
time will have any effect on the continued validity or sufficiency of such
permits, nor will any additional permits be required by virtue of the execution,
delivery or performance of this Agreement to enable the conduct of the Business
as now conducted.
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2.14 REGULATORY COMPLIANCE. Except as disclosed in the Seller SEC
Reports filed prior to the date hereof:
(A) Each Partnership has timely filed or otherwise provided
all registrations, reports, data, and other information and applications with
respect to its medical device, pharmaceutical, consumer, health care, and other
governmentally regulated products (the "REGULATED PRODUCTS") required to be
filed with or otherwise provided during the Ownership Period to the United
States Food and Drug Administration (the "FDA") or any other Authority with
jurisdiction over the manufacture, use, or sale of the Regulated Products, has
complied in all material respects during the Ownership Period with all legal
requirements of the FDA or other Authority with respect to the Regulated
Products (including but not limited to the Federal Food, Drug, and Cosmetic Act,
the Medicare Anti-Kickback Statute, the Health Insurance Portability and
Accountability Act, the Federal False Claims Act, the Federal laws concerning
physician self-referral known as "Stark Laws", and the rules and regulations of
the Joint Commission on Accreditation of Healthcare Organizations) in all
material respects, and all regulatory licenses or approvals in respect thereof
are in full force and effect. All documentation, correspondence, reports, data,
analyses and certifications relating to or regarding any medical devices of the
Partnerships filed with or delivered by or on behalf of the Partnerships during
the Ownership Period to any Authority was in all material respects true and
accurate when so filed or delivered and, to the knowledge of the Seller, remains
true and accurate in all material respects. Each Regulated Product is being
distributed and marketed in all material respects in compliance with all
applicable requirements under all applicable laws.
(B) No request has been made during the Ownership Period to
recall, withdraw, suspend or discontinue any Regulated Product distributed or
managed by the Partnerships (whether voluntarily or otherwise). To the knowledge
of the Seller, no proceedings (whether completed or pending) seeking the recall,
withdrawal, suspension or seizure of any Regulated Product managed or
distributed by the Partnerships during the Ownership Period are pending or, to
the knowledge of the Seller, threatened against the Partnerships, nor have any
such proceedings ever been instituted during the Ownership Period.
(C) Neither the Seller nor the Partnerships has received any
written notice from the FDA or any other Authority during the Ownership Period
of any action to withdraw its approval or request the recall of any Regulated
Product with repect to the conduct or operation of the Business, any action to
enjoin production of any such Regulated Product.






