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Title: |
Asset Purchase Agreement |
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Entities: |
Nabi Biopharmaceuticals; Hale and Dorr LLP; Nutter, McClennen & Fish |
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Date: |
2003 |
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Preview shows 30KB of 199KB total |
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Price: |
$59 |
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ID: |
#309053 |
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[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASSET PURCHASE AGREEMENT
BY AND BETWEEN
BRAINTREE LABORATORIES, INC.
and
NABI BIOPHARMACEUTICALS
JUNE 23, 2003
{PAGE}
ASSET PURCHASE AGREEMENT
This ASSET PURCHASE AGREEMENT (the "Agreement") is entered into as of
June 23, 2003 by and between Braintree Laboratories, Inc., a Massachusetts
corporation (the "Seller"), and Nabi Biopharmaceuticals, a Delaware corporation
(the "Buyer"). The Seller and the Buyer are referred to collectively herein as
the "Parties."
INTRODUCTION
The Seller is engaged, among other matters, in the business of
manufacturing, marketing and selling a line of phosphate binder calcium acetate
products known as the Phos-Lo product line (such business being referred to as
the "Product Line Operations "); and
The Buyer desires to purchase from the Seller, and the Seller desires
to sell to the Buyer, the Seller's right, title and interest in and/or the right
to use certain assets and properties of the Seller relating to the Product Line
Operations, subject to the assumption by the Buyer of specified related
liabilities, upon the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the representations, warranties,
covenants and agreements contained in this Agreement and other good and valuable
consideration, the receipt of which is hereby acknowledged, the Parties agree as
follows:
ARTICLE I-
DEFINITIONS
1.1 DEFINITIONS. Whenever used in this Agreement, the terms defined
below shall have the indicated meaning:
"ACQUIRED ASSETS" shall have the meaning set forth in Section 2.1(a).
"ACQUISITION PROPOSAL" shall have the meaning set forth in Section 5.4.
"ACT" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321, et
seq., as amended, and the rules and regulations promulgated thereunder.
"ADDITIONAL CASH PAYMENTS" shall have the meaning set forth in Section
2.2(a)(ii).
"AGREED AMOUNT" shall have the meaning set forth in Section 7.3(b).
"AGREEMENT" shall have the meaning set forth in the first paragraph of
this Agreement.
"AFFILIATE" shall mean, with respect to any Person, any Person which
directly or indirectly through stock ownership or otherwise either controls, or
is controlled by or under common control with, such Person.
"ANCILLARY AGREEMENTS" shall have the meaning set forth in Section
2.3(b).
"APPLICABLE PERMITS" shall have the meaning set forth in Section 3.13.
{PAGE}
"ASSIGNED CONTRACTS" shall have the meaning set forth in Section
2.1(a)(ii).
"ASSIGNED PERMITS" shall mean the Applicable Permits which are
identified on Section 3.13 of the Seller's Disclosure Schedule as Assigned
Permits.
"ASSUMED LIABILITIES" shall have the meaning set forth in Section
2.1(c).
"ASSUMPTION AGREEMENT" shall have the meaning set forth in Section
2.3(b)(vi).
"BUNDLED CONTRACTS" shall mean those contracts, agreements or
arrangements (oral or written) pursuant to which the Seller is either (a)
selling to third parties Phos-Lo Products together with other products of the
Seller not included in the Acquired Assets, or (b) receiving from third parties
services related to the Product Line Operations together with services related
to other businesses of the Seller, including without limitation agreements
between the Seller and group purchasing organizations and rebate agreements,
including those contracts, agreements and arrangements identified as Bundled
Contracts on SCHEDULE 2.1(B)(VII) hereto.
"BUSINESS DAY" shall have the meaning set forth in Section 2.3(a).
"BUYER" shall have the meaning set forth in the first paragraph of this
Agreement..
"BUYER CERTIFICATE" shall have the meaning set forth in Section 6.2(d).
"BUYER COMMON STOCK" shall have the meaning set forth in Section
2.2(a)(i).
"BUYER INDEMNITEES" shall have the meaning set forth in Section 7.1.
"BUYER MATERIAL ADVERSE EFFECT" means any change, effect or
circumstance that, individually or in the aggregate (unless otherwise noted),
(a) is materially adverse to the business, financial condition or results of
operations of the Buyer (other than changes, effects or circumstances that are
the result of economic factors affecting the economy as a whole or that are the
result of factors generally affecting the industry or specific markets in which
the Buyer competes which factors do not substantially disproportionately affect
the Buyer) or (b) materially impairs the ability of the Buyer to consummate the
transactions contemplated by this Agreement; PROVIDED, HOWEVER, that a "Buyer
Material Adverse Effect" shall not include any adverse change, effect or
circumstance (i) arising out of or resulting from acts or omissions by the Buyer
as contemplated by or pursuant to this Agreement, (ii) arising out of or
resulting from acts or omissions of the Seller, including without limitation
acts or omissions contemplated by or pursuant to this Agreement, or (iii) that
is attributable to the announcement or performance of this Agreement or the
transactions contemplated by this Agreement.
"BUYER PREFERRED STOCK" shall have the meaning set forth in Section
4.2.
"BUYER REPORTS" shall have the meaning set forth in Section 4.5.
"BUYER'S DISCLOSURE SCHEDULE" means the Disclosure Schedule provided by
the Buyer to the Seller on the date hereof.
2
{PAGE}
"CLAIM NOTICE" shall have the meaning set forth in Section 7.3(b).
"CLAIMED AMOUNT" shall have the meaning set forth in Section 7.3(b).
"CLOSING" shall have the meaning set forth in Section 2.3(a).
"CLOSING DATE" shall have the meaning set forth in Section 2.3(a).
"CLOSING CASH PAYMENT" shall have the meaning set forth in Section
2.2(a)(i).
"CLOSING RESTRICTED PERIOD" shall have the meaning set forth in Section
9.2.
"CLOSING STOCK PAYMENT" shall have the meaning set forth in Section
2.2(a)(i).
"CONFIDENTIALITY AGREEMENT" shall have the meaning set forth in Section
5.3(a).
"DAMAGES" shall have the meaning set forth in Section 7.1.
"DEFERRED PAYMENT PERIOD" shall have the meaning set forth in Section
2.4.
"DEFERRED PAYMENTS" shall have the meaning set forth in Section 2.4.
"DESIGNATED INTELLECTUAL PROPERTY" shall have the meaning set forth in
Section 3.8(a).
"DISCOUNTS" means amounts claimed as discounts with respect to Phos-Lo
Products sold (a) on or before the Closing Date or (b) under any Excluded
Contract.
"ENVIRONMENT" means any surface water, ground water, drinking water
supply, land surface or subsurface strata, or ambient or indoor air.
"ENVIRONMENTAL LAW" means any federal, state, provincial, or municipal
statute, rule or regulation as in effect as of the date of this Agreement
relating to the protection of the Environment or occupational health and safety,
including without limitation any statute or regulation pertaining to (a) the
presence, manufacture, processing, use, treatment, storage, disposal,
transportation, handling or generation of Materials of Environmental Concern;
(b) air, water and noise pollution; (c) groundwater and soil contamination; or
(d) the Release or threatened Release of Materials of Environmental Concern to
the Environment.
"ENVIRONMENTAL LIABILITIES" means regardless of whether any of the
following are contained in any Disclosure Schedule to this Agreement or
otherwise disclosed to the Buyer prior to the Closing, any and all costs
(including without limitation the costs of investigation, clean up actions,
remedial actions or other response costs) (whether known or unknown, foreseen or
unforeseen, contingent or otherwise, fixed or absolute or present or arising in
the future), asserted against or incurred by the Buyer arising out of or
relating to any of the following conditions or events, first occurring on or
before the Closing Date: (a) the presence, Release, or exposure to Materials of
Environmental Concern in connection with the operation of the Product Line
Operations at, on, in, or from any property currently or formerly owned, leased
3
{PAGE}
or operated by the Seller or its predecessors on which the Product Line
Operations were conducted, (b) any Off-Site Liability, and (c) any violation of
any Environmental Law in connection with the Product Line Operations (including
any costs and expenses incurred after the Closing to come into compliance with
such Environmental Law).
"ENVIRONMENTAL MATTERS" means any legal obligation or liability arising
under Environmental Law.
"ENVIRONMENTAL PERMITS" shall have the meaning set forth in Section
3.11(c).
"EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended.
"EXCLUDED ASSETS" shall have the meaning set forth in Section 2.1(b).
"EXCLUDED CONTRACTS" shall have the meaning set forth in Section
2.1(b)(vii).
"EXCLUDED LIABILITIES" shall have the meaning set forth in Section
2.1(d).
"EXCLUDED PERMITS" shall mean the Applicable Permits which are
identified on Section 3.13 of the Seller's Disclosure Schedule as Excluded
Permits.
"FDA" shall have the meaning set forth in Section 2.1(a)(i).
"FDA APPROVAL" means the definitive approval, clearance or
authorization of the FDA that allows Seller to make, sell, promote, market and
distribute the Products for therapeutic use in humans on a lawful and commercial
basis in the United States.
"FINISHED GOODS INVENTORY" shall have the meaning set forth in Section
2.1(a)(xii).
"GAAP" means generally accepted accounting principles as used in the
United States of America, consistently applied.
"GOOD PRACTICES" means compliance in all material respects with the
applicable requirements contained in "Good Laboratory Practices,"
"Investigational New Drug" and/or "current Good Manufacturing Practices"
regulations as promulgated by the FDA.
"GOVERNMENTAL AUTHORITY" shall mean any governmental department,
commission, board, bureau, agency, court or other instrumentality of the United
States, or any county, jurisdiction, municipality or other political subdivision
thereof.
"GOVERNMENTAL FILINGS" shall have the meaning set forth in Section
5.1(a).
"HART-SCOTT-RODINO ACT" shall have the meaning set forth in Section
3.3.
"INDEMNIFIED PARTY" shall have the meaning set forth in Section 7.3(a).
"INDEMNIFYING PARTY" shall have the meaning set forth in Section
7.3(a).
"INFORMATION" shall have the meaning set forth in Section 9.1(a).
4
{PAGE}
"INTANGIBLE PROPERTY RIGHTS" shall mean those set forth in Section
2.1(a)(v).
"KNOWLEDGE OF THE SELLER" shall have the meaning set forth in Article
III.
"KNOWLEDGE OF THE BUYER" shall have the meaning set forth in Article
IV.
"LIEN" shall mean any lien, charge, claim, pledge, security interest,
conditional sale agreement or other title retention agreement, lease, mortgage,
security agreement, right of first refusal, option, restriction, license,
covenant, or other encumbrance (including the filing of, or agreement to give
any financing statement under the Uniform Commercial Code or statute or law of
any jurisdiction).
"MANUFACTURING AGREEMENT" shall have the meaning set forth in Section
2.3(b)(viii).
"MASTER FORMULATIONS" shall have the meaning set forth in Section
2.1(a)(v).
"MATERIALS OF ENVIRONMENTAL CONCERN" means any hazardous substance,
pollutant or contaminant, as those terms are defined under the federal
Comprehensive Environmental Response, Compensation and Liability Act of 1980, as
amended ("CERCLA") or similar Environmental Laws; solid waste and hazardous
waste, as those terms are defined in the Federal Resource Conservation and
Recovery Act or similar Environmental Laws; oil, petroleum and petroleum
products; asbestos or asbestos-containing materials, polychlorinated byphenyls
("PCBs"), radioactive materials and any other hazardous or toxic substances,
materials or wastes.
"MEDICAL PRODUCT REGULATORY AUTHORITY" means any Governmental Authority
that is concerned with the safety, efficacy, reliability, manufacture,
investigation, sale or marketing of pharmaceuticals, medical products, biologics
or biopharmaceuticals, including, without limitation, the FDA.
"NDA FILING DATE" shall have the meaning set forth in Section 3.5(a).
"NDAS" shall have the meaning set forth in Section 2.1(a)(i).
"OFF-SITE LIABILITIES" means Environmental Matters resulting from any
transportation, treatment, storage, disposal or Release, or the arrangement
therefor, in connection with the Product Line Operations, of any Materials of
Environmental Concern, to or at any property, location, site or facility other
than a Product Line Property.
"PARTIES" shall have the meaning set forth in the first paragraph of
this Agreement.
"PATENT AGREEMENT" shall have the meaning set forth in Section
2.3(b)(v).
"PATENT RIGHTS" shall have the meaning set forth in Section 2.1(a)(iv).
"PERSON" shall mean an individual, a corporation, a limited liability
company, a partnership, an association, a trust or other entity or organization,
including a federal, state, local or foreign government or regulatory entity or
political subdivision or an agency or instrumentality thereof.
5
{PAGE}
"PHOS-LO GELCAP" means the size 0 capsule dose of Phos-Lo (667 mg) or
the size 2 (333.5 mg) capsule dose of Phos-Lo as approved in NDA 21-160.
"PHOS-LO NET SALES" means the excess of (a) the gross amount invoiced
by the Buyer or its subsidiaries or Affiliates from or on account of sales or
other dispositions of any Phos-Lo Products over (b) any Phos Lo Net Sales
Deductions. The Buyer shall allocate Phos-Lo Net Sales Deductions to the Phos-Lo
Products in a manner consistent with the manner in which it allocates similar
deductions to products in the balance of its business. Phos-Lo Net Sales shall
not result from any transfer among the Buyer and any of its subsidiaries or
Affiliates for resale, but shall result from the resale by the subsidiary or
Affiliate.
"PHOS-LO NET SALES DEDUCTIONS" means with respect to invoiced sales of
Phos-Lo Products:
[***].
"PHOS-LO NET SALES STATEMENT" shall have the meaning set forth in
Section 2.4(b).
"PHOS-LO PRODUCTS" means the products set forth on SCHEDULE A hereto.
For purposes of Phos-Lo Net Sales, (i) any similar calcium acetate phosphate
binder products, in any variation, in any dosage form or by any name and (ii)
any other product marketed under the Phos-Lo trademark or under any other
trademark that is confusingly similar to the Phos-Lo trademark.
"PHOS-LO SUBLICENSE INCOME" means all amounts, monetary or
non-monetary, collected or received by or paid or credited to or for the benefit
of the Buyer or its Affiliates from non-Affiliate third parties in connection
with or related to the licensing or sublicensing to such third parties of rights
to the Phos-Lo Products in the United States, including without limitation all
upfront fees, milestone payments and royalties but excluding transfer pricing
amounts paid in respect of Phos-Lo Products supplied to such third parties.
"PHOS-LO TABLETS" means the round tablet dose of Phos-Lo (667 mg) as
approved by NDA 19-976.
"PRODUCT LINE OPERATIONS" shall have the meaning set forth in the
Introduction.
"PRODUCT LINE PROPERTIES" means all real property that is used in the
Product Line Operations.
"REBATE CHARGES" means amounts claimed by or under Medicaid, state
rebate programs, pharmaceutical benefit management organizations, managed care
organizations, and other Persons (collectively, "Rebate Parties") as rebates
under contracts between the Rebate Parties and the Seller (it being agreed that,
with respect to Medicaid and state rebate programs, such amounts shall be
limited to claims with respect to the Seller's NDC numbers).
"REGISTRATIONS" shall have the meaning set forth in Section 2.1(a)(i).
"REGISTRATION INDEMNIFIED PARTY" shall have the meaning set forth in
Section 9.8(d)(iii).
6
{PAGE}
"REGISTRATION INDEMNIFYING PARTY" shall have the meaning set forth in
Section 9.8(d)(iii).
"REGISTRATION STATEMENT" shall have the meaning set forth in Section
9.8(a).
"RELEASE" means any spilling, leaking, pumping, pouring, emitting,
emptying, discharging, injecting, escaping, leaching, dumping, or disposing into
the Environment (including the abandonment or discarding of barrels, containers,
and other closed receptacles containing any Materials of Environmental Concern).
"RESTRICTED BUSINESS" shall have the meaning set forth in Section 9.2.
"RETAINED MARKS" shall have the meaning set forth in Section 9.3(a).
"SCIENTIFIC DATA" shall have the meaning set forth in Section 3.19(a).
"SEC" shall have the meaning set forth in Section 4.5.
"SECURITIES ACT" means the Securities Act of 1933, as amended.
"SELLER" shall have the meaning set forth in the first paragraph of
this Agreement.
"SELLER MATERIAL ADVERSE EFFECT" shall have the meaning set forth in
Section 3.1.
"SELLER CERTIFICATE" shall have the meaning set forth in Section
6.1(d).
"SELLER INDEMNITEES" shall have the meaning set forth in Section 7.2.
"SELLER'S DISCLOSURE SCHEDULE" shall have the meaning set forth in
Article III.
"SHARES" shall have the meaning set forth in Section 2.2(a)(i).
"SPECIFICATIONS" shall have the meaning set forth in Section 3.18.
"TAXES" (and with correlative meanings, "TAX" and "TAXABLE") shall mean
all taxes of any kind imposed by a Governmental Authority, including but not
limited to those on, or measured by or referred to as income, gross receipts,
financial operation, sales, use, AD VALOREM, value added, alternative or add-on
minimum, franchise, profits, license, withholding, payroll (including all
contributions or premiums pursuant to governmental social security laws or
pursuant to other tax laws and regulations), employment, excise, or severance.
"TAX RETURNS" shall mean all reports, returns, schedules and any other
documents required to be filed with a Governmental Authority with respect to
Taxes.
"THIRD PARTY CLAIM" shall have the meaning set forth in Section 7.3(a).
"THIRD PARTY CONSENTS" shall have the meaning set forth in Section
5.1(a).
"TRADEMARK AGREEMENT" shall have the meaning set forth in Section
2.3(b)(v).
7
{PAGE}
"TRADEMARK RIGHTS" shall have the meaning set forth in Section
2.1(a)(iii).
"TRANSITION SERVICES AGREEMENT" shall have the meaning set forth in
Section 2.3(b)(viii).
"WHOLESALER CHARGES" means amounts claimed by wholesalers of the
Phos-Lo Products as chargebacks under contracts between group purchasing
organizations, FSS and PHS (collectively, "GPOs") and the Seller and amounts
claimed by GPOs as administrative or marketing fees under contracts between GPOs
and the Seller.
ARTICLE II-
ASSET PURCHASE
2.1 PURCHASE AND SALE OF ASSETS; ASSUMPTION OF LIABILITIES.
(a) TRANSFER OF ASSETS. On the basis of the representations,
warranties, covenants and agreements and subject to the satisfaction or waiver
of the conditions set forth in this Agreement, at the Closing, the Seller shall
sell, convey, assign, transfer and deliver to the Buyer (or one or more of its
assignees), and the Buyer shall purchase and acquire from the Seller, all of the
Seller's right, title and interest in and to the following specifically
identified assets, properties and rights of the Seller used in connection with
and relating to the Product Line Operations (the "Acquired Assets"), free and
clear of all Liens other than Liens for Taxes that are not yet due and payable
and Liens arising solely by action of the Buyer.
(i) the regulatory approvals, registrations and
associated materials (including the product dossier) relating to Phos-Lo
Products and the Product Line Operations (the "Registrations"), including
without limitation the New Drug Applications (No. 19-976 and No. 21-160) issued
by the United States Food and Drug Administration (the "FDA") (together with all
amendments, supplements and updates thereto (the "NDAs")), and the other
approvals, registrations, and associated materials set forth on SCHEDULE
2.1(A)(I) hereto, but excluding any manufacturing registrations;
(ii) the oral and written contracts, licenses,
agreements and other instruments related to the Product Line Operations set
forth or described on SCHEDULE 2.1(A)(II) hereto (the "Assigned Contracts");
(iii) the name "Phos-Lo" and any variant thereof, the
trademarks and trade names and all registrations thereof and all related
registration applications set forth on SCHEDULE 2.1(A)(III) hereto (the
"Trademark Rights"), and all domain names owned and used by the Seller solely in
connection with sales of Phos-Lo Products and the Product Line Operations set
forth on SCHEDULE 2.1(A)(III) hereto;
(iv) the patents and patent applications set forth on
SCHEDULE 2.1(A)(IV) hereto (the "Patent Rights");
(v) intangible property rights (other than the
Trademark Rights and the Patent Rights) to the extent that such intangible
property rights relate primarily to the Phos-Lo Products or the Product Line
Operations, whether or not patentable, including but not limited to inventions,
8
{PAGE}
discoveries, trade secrets, technical information, master formulations for the
Phos-Lo Products ("Master Formulations"), master processes used by the Seller
for manufacturing the Phos-Lo Products from the Master Formulations, know-how,
copyrights and other confidential business information (collectively, the
"Intangible Property Rights");
(vi) the exclusive right to satisfy all unfilled
purchase orders relating to the Phos-Lo Products as of the Closing Date;
(vii) all brochures and other promotional and printed
materials, trade show materials (including displays), videos, web pages,
advertising and/or marketing materials, including without limitation materials
containing post-marketing clinical data, in the Seller's possession or under its
control used primarily in connection with the sale of the Phos-Lo Products
and/or the conduct of the Product Line Operations;
(viii) all warranties and guarantees and other
similar contractual rights made by third parties in favor of the Seller with
respect to the Phos-Lo Products or the Product Line Operations;
(ix) copies of all customer and supplier lists,
account lists, call data, sales history, call notes, marketing studies,
consultant reports, physician databases, and correspondence (excluding invoices)
with respect to the Phos-Lo Products or the Product Line Operations to the
extent maintained by the Seller, and all complaint files and adverse event files
with respect to the Phos-Lo Products or the Product Line Operations;
(x) all training materials used primarily in
connection with the Product Line Operations, including an outline of training,
quizzes and answers that accompany the written training materials;
(xi) the Assigned Permits;
(xii) all Phos-Lo Products held in inventory as
finished goods as of the Closing Date, which shall include not less than [***]
bottles of Phos-Lo Tablets and [***] bottles of Phos-Lo Gel Caps (the "Finished
Goods Inventory");
(xiii) the Scientific Data, including without
limitation any rights of access that the Seller has to the Scientific Data;
(xiv) all the goodwill of the Product Line
Operations;
(xv) rights of access (which shall include the right
to copy) to all financial records maintained by the Seller in connection with
the sale of Phos-Lo Products relating to sales, accounts receivable, returns,
chargebacks, rebates and discounts; and
(xvi) all rights of the Seller and its Affiliates to
develop, manufacture, sell, distribute, promote, and use the Phos-Lo Products
worldwide.
The Seller shall deliver to the Buyer two (2) Business Days prior to the Closing
Date a proposed updated SCHEDULE 2.1(A)(II) covering contracts, licenses,
9
{PAGE}
agreements and other instruments entered into subsequent to the date hereof that
would have otherwise been included on SCHEDULE 2.1(A)(II) if entered into prior
to the date hereof, which shall become Assigned Contracts hereunder only to the
extent that the Buyer agrees at the Closing that they shall be treated as such.
(b) EXCLUDED ASSETS. Notwithstanding anything to the contrary
in this Agreement, the Seller is not selling, conveying, assigning, transferring
or delivering to the Buyer any assets, properties or rights of the Seller other
than those specifically identified in Section 2.1(a). The assets, properties and
rights of the Seller not being sold, conveyed, assigned, transferred or
delivered to the Buyer hereunder (the "Excluded Assets"), include without
limitation the following assets, properties and rights of the Seller, whether or
not related to the Product Line Operations:
(i) all cash and cash equivalents or similar
investments, bank accounts, Tax deposits, commercial paper, certificates of
deposit, Treasury bills and other marketable securities;
(ii) accounts receivable and other receivables,
whether or not billed;
(iii) inventories of raw materials, work in process
and packaging materials;
(iv) rights to insurance claims, related refunds and
proceeds;
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