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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported)
May 4, 2006
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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California
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001-14758
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33-0476164 |
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(IRS Employer Identification
No.) |
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3260 Whipple Road Union City, California
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94587 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants
telephone number, including area code:
(510) 400-0700
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 1.01 Entry into A Material Definitive Agreement.
See the disclosure set forth under Item 2.01, which is incorporated by reference into this
Item 1.01.
Item 2.01 Completion of Acquisition or Disposition of Assets.
On May 4, 2006, Questcor Pharmaceuticals, Inc. (the Company) completed its acquisition of
the U.S. rights to Doral®, a non-narcotic, selective benzodiazepine receptor agonist that is
indicated for the treatment of insomnia (Doral), from MedPointe Inc. (MedPointe) pursuant to
the terms of an Assignment and Assumption Agreement (the Agreement) entered into by Company and
MedPointe (the Transaction). As consideration for the U.S. rights to Doral, the Company agreed
to pay MedPointe $2.5 million in cash on May 4, 2006, and a future milestone payment of $1.5
million. Gross ex-factory sales for Doral in 2005 were $1.1 million. The foregoing description of
the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy
of which is attached hereto as Exhibit 2.1.
Item 7.01 Regulation FD Disclosure.
On May 5, 2006, the Company issued a press release announcing the Transaction. A copy of the
press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
In accordance with General Instruction B.2. of Form 8-K, the information furnished pursuant to
this Item 7.01, including Exhibit 99.1, shall not be deemed filed for the purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to
the liability of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act except as expressly set forth by
specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
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Exhibit Description |
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Exhibit |
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Number |
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Assignment and Assumption Agreement by and between Questcor
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2.1 |
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Pharmaceuticals, Inc. and MedPointe Inc., dated as of May 4, 2006. |
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Press Release, dated May 5, 2006.
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99.1 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Questcor Pharmaceuticals, Inc. |
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Date: May 10, 2006
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By:
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/s/ James L. Fares |
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James L. Fares |
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President and Chief Executive Officer |
EXHIBIT INDEX
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Exhibit No. |
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Exhibit Description |
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2.1
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Assignment and Assumption Agreement by and between Questcor
Pharmaceuticals, Inc. and MedPointe Inc., dated as of May 4, 2006. |
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99.1
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Press Release, dated May 5, 2006. |
exv2w1
Exhibit 2.1
ASSIGNMENT AND ASSUMPTION AGREEMENT
Dated as of May 4, 2006
by and between
Questcor Pharmaceuticals, Inc.,
a California corporation,
PURCHASER
and
MedPointe Healthcare Inc.,
a Delaware corporation,
SELLER
TABLE OF CONTENTS
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ARTICLE I. DEFINITIONS |
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Section 1.1. Definitions |
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ARTICLE II. SALE AND PURCHASE OF PURCHASED ASSETS |
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Section 2.1. Purchase and Sale |
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Section 2.2. Purchased Assets |
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Section 2.3. Assumption of Certain Losses and Obligations |
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Section 2.4. Proration |
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ARTICLE III. PURCHASE PRICE |
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Section 3.1. Purchase Price |
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Section 3.2. Allocation of Purchase Price |
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Section 3.3. Transfer Taxes |
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ARTICLE IV. THE CLOSING; POST-CLOSING PAYMENT |
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Section 4.1. Closing Date |
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Section 4.2. Transactions to Be Effected at the Closing |
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Section 4.3. Post Closing Payment |
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Section 4.4. Transfer of Product Inventory |
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ARTICLE V. REPRESENTATIONS AND WARRANTIES OF SELLER |
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Section 5.1. Sellers Organization; Good Standing |
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Section 5.2. Authority; Execution and Delivery |
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Section 5.3. Consents; No Violation, Etc |
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Section 5.4. Title to Purchased Assets |
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Section 5.5. Inventory |
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Section 5.6. Litigation |
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Section 5.7. Product Sales, Returns, Pipeline |
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Section 5.8. Assigned Contracts |
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ARTICLE VI. CERTAIN COVENANTS AND AGREEMENTS OF SELLER |
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Section 6.1. Post-Closing Orders and Payments |
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Section 6.2. Notification of Customers |
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Section 6.3. Freedom from Suit |
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ARTICLE VII. REPRESENTATIONS AND WARRANTIES OF PURCHASER |
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Section 7.1. Purchasers Organization; Good Standing |
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Section 7.2. Authority; Execution and Delivery |
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Section 7.3. Consents; No Violations, Etc |
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ARTICLE VIII. CERTAIN COVENANTS AND AGREEMENTS |
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Section 8.1. Transferred Documentation |
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Section 8.2. Confidentiality |
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Section 8.3. Trade Returns, Medicaid Rebates, Chargebacks |
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Section 8.4. Adverse Experience Reports |
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Section 8.5. Product Complaints and Inquires |
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Section 8.6. Transfer of NDA, Etc |
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Section 8.7. Response to Medical Inquiries and Product Complaints |
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Section 8.8. Noncompetition |
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ARTICLE IX. CLOSING DELIVERABLES |
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Section 9.1. Seller Deliverables |
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Section 9.2. Purchaser Deliverables |
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ARTICLE X. SURVIVAL OF REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION |
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Section 10.1. Survival |
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Section 10.2. Indemnification by Seller |
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Section 10.3. Indemnification by Purchaser |
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Section 10.4. Procedure |
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Section 10.5. Certain Limitations on Indemnification |
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ARTICLE XI. GENERAL PROVISIONS |
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Section 11.1. Amendments and Waivers |
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Section 11.2. Expenses |
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Section 11.3. Further Assurances and Actions |
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Section 11.4. Notices |
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Section 11.5. Interpretation |
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Section 11.6. Severability |
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Section 11.7. Counterparts |
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Section 11.8. Entire Agreement; No Third Party Beneficiaries |
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Section 11.9. Governing Law; Venue |
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Section 11.10. Publicity |
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Section 11.11. Assignment |
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EXHIBITS
EXHIBIT A Intentionally Omitted
EXHIBIT B Supply Agreement
EXHIBIT C Purchase Price Allocation
EXHIBIT D Bill of Sale and Assignment
EXHIBIT E FDA notice letter
ASSIGNMENT AND ASSUMPTION AGREEMENT
THIS ASSIGNMENT AND ASSUMPTION AGREEMENT, dated as of May 4, 2006 (this Agreement), is by
and between Questcor Pharmaceuticals, Inc., a California corporation (Purchaser), and MedPointe
Healthcare Inc., a Delaware corporation (Seller).
WHEREAS, Seller sells Doral (as defined below) commercially; and
WHEREAS, Seller desires to sell to Purchaser, and Purchaser desires to purchase from Seller,
certain Purchased Assets (as hereinafter defined), including contract rights, related to Doral
within the Territory (as hereinafter defined), all upon the terms and subject to the conditions
hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and for other good
and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties
hereto hereby agree as follows:
ARTICLE I. DEFINITIONS
Section 1.1. Definitions. As used in this Agreement, the following terms
shall have the meanings set forth below:
Doral shall mean the pharmaceutical product currently marketed and sold as Doral® (Quazepam)
under the NDA.
Affiliate shall mean, with respect to any Person, any other Person that directly or
indirectly Controls, is Controlled by or is under common Control with such first Person. A Person
shall be deemed to Control another Person if such first Person has the power to direct or cause
the direction of such other Person, whether through ownership of securities, by contract or
otherwise.
Assigned Contracts shall mean the following agreements between IVAX Research, Inc. (f/k/a
Baker Cummins Pharmaceuticals, Inc.) and Seller: (i) that certain License Agreement dated
September 30, 1990 and (ii) that certain Trademark License Agreement dated September 30, 1990.
Assumed Contractual Obligations shall mean the post-Closing contractual obligations under
the Assigned Contracts.
Assumed Liabilities shall have the meaning given such term in Section 2.3(a).
Business Day shall mean any day other than a Saturday, Sunday or other day on which banks in
the City of New York are permitted or required to close by law or regulation.
Closing and Closing Date shall have the respective meanings given such terms in Section
4.1.
Confidentiality Agreement shall have the meaning given such term in Section 8.2.
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Contracts shall mean contracts, leases, indentures, agreements, purchase orders and all
other legally binding arrangements, whether in existence on the date hereof or subsequently entered
into, including all amendments thereto.
Customer Orders shall have the meaning given such term in Section 2.2(a)(ix).
Encumbrance shall mean any mortgage, charge, lien, security interest, easement, right of
way, pledge or encumbrance of any nature whatsoever.
Excluded Assets shall have the meaning given such term in Section 2.2(b).
Excluded Intellectual Property shall mean (i) Seller Trademarks, (ii) Seller Trade Dress,
(iii) any intellectual property that is not exclusively used by the Seller or its Affiliates in the
manufacturing, marketing, sale or distribution of Doral in the Territory, and (iv) any computer
programs and software.
Excluded Liabilities shall have the meaning given such term in Section 2.3(b).
Exhibits shall mean, collectively, the Exhibits referred to throughout this Agreement.
FDA shall mean the United States Food and Drug Administration or any successor agency
thereto.
GAAP shall mean United States generally accepted accounting principles.
Governmental Entity shall mean any court, administrative agency or commission or other
governmental authority or instrumentality, whether domestic or foreign.
Governmental Rule shall mean any law, judgment, order, decree, statute, ordinance, rule or
regulation issued or promulgated by any Governmental Entity.
Indemnified Party shall have the meaning given such term in Section 10.4.
Indemnifying Party shall have the meaning given such term in Section 10.4.
Knowledge of Seller shall mean the actual knowledge of the Seller.
Liabilities shall mean any and all debts, liabilities and obligations, whether accrued or
fixed, absolute or contingent, matured or unmatured, or determined or determinable, including those
arising under any law, action or governmental order and those arising under any contract,
agreement, arrangement, commitment or undertaking, or otherwise.
Losses shall mean, collectively, any and all damages, losses, Taxes, Liabilities, claims,
judgments, penalties, costs and expenses (including reasonable attorneys fees and litigation
expenses).
Material Adverse Effect shall mean an effect which is materially adverse to the Purchased
Assets taken as a whole, but shall not include (i) any adverse effect due to changes in conditions
generally affecting (A) the pharmaceutical industry or (B) the United States economy
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as a whole, (ii) any changes or adverse effect caused by, or relating to, the announcement of
this Agreement and the transactions contemplated by this Agreement or (iii) any adverse effect due
to generally applicable legal or regulatory changes.
Medicaid Rebates shall mean all state and federal Medicaid rebates and reimbursements
related to Doral.
NDC Number shall mean the national drug code number associated with Doral.
NDA shall mean the New Drug Application No. 018708, as filed with the FDA pursuant to 21
C.F.R., Part 314, and all supplements, amendments and revisions thereto.
Non-Competition Period shall have the meaning given such term in Section 8.8.
Permitted Encumbrance shall mean (i) any Encumbrance for Taxes, assessments and other
governmental charges that are not yet due and payable or that may thereafter be paid without
penalty, or that are being contested in good faith by appropriate proceedings, (ii) mechanics,
carriers, workers, repairers and similar Liens arising or incurred in the ordinary course of
business, and (iii) such Encumbrances as would not have a Material Adverse Effect.
Person shall mean any individual, corporation, partnership, limited liability company, joint
venture, trust, business association, organization, Governmental Entity or other entity.
Product Intellectual Property shall mean all (i) Product Technology and (ii) Sample Pack
Trade Dress, in each case to the extent used by Seller or its Affiliates exclusively in the
manufacture, marketing, sale and distribution of Doral in the Territory, but excluding (in all
cases) Excluded Intellectual Property.
Product Inventory shall mean Sellers existing finished goods inventory of 15 mg Doral in
packs of 100 each, which will be overlabeled in accordance with Section 2.7 of the Supply
Agreement.
Product Marketing Materials shall mean all sales training, marketing, and other promotional
materials used exclusively with respect to Doral in the Territory to the extent such materials are
within the possession of Seller or its Affiliates as of the Closing Date.
Product Medical Materials shall mean all of the following documents or materials within
Sellers or its Affiliates possession as of the Closing Date: (i) all adverse event reports
relating to Doral or its generic equivalents in the Territory, including any official
correspondence with the FDA, reports or other documents relating thereto, (ii) all data,
information and files relating to adverse experiences relating to Doral in the Territory, and (iii)
all medical responses and written, phone and personal contact inquiries relating to Doral that are
in Sellers possession.
Product Technology shall mean the manufacturing know-how that is used by Seller exclusively
in the manufacture of Doral in the Territory, including but not limited to, specifications and test
methods, manufacturing and packaging instructions, master formula, validation reports (process,
analytical methods and cleaning), stability data and analytical methods.
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Sample Pack Trade Dress shall mean the current trade dress of the packaging of Doral sample
packs, but excluding the Seller Trade Dress.
Purchased Assets shall have the meaning given such term in Section 2.2(a).
Purchaser shall have the meaning given such term in the recitals.
Purchaser Indemnified Parties shall have the meaning given such term in Section 10.2.
Purchase Price shall have the meaning given such term in Section 3.1.
Quazepam shall mean quazepam, the chemical name of which is 7-chloro-1-(2,2,2
trifluoroethyl)-1,3-dihydro-5-(2-flurophenyl)-2H-1,4-benzo-2-thione, and its pharmaceutically
acceptable salts.
Schedules shall mean, collectively, the Schedules referred to throughout this Agreement.
Seller shall have the meaning given such term in the recitals.
Seller Indemnified Parties shall have the meaning given such term in Section 10.3.
Seller Trade Dress shall mean the stripes, bands or other designs, coloring and other trade
dress used on or in connection with the packaging of Doral sample packs to the extent used on other
product packaging of Seller or its Affiliates.
Seller Trademarks shall mean (i) the MedPointe Healthcare Inc. name or any variations
thereof, (ii) the name Carter-Wallace, Inc. and all formatives and derivatives thereof, all
composite marks including such names or any such formatives or derivatives and any colorable
imitation of any of the foregoing, (iii) all Trademarks currently used by Seller in connection with
the manufacture, marketing, sale and distribution of Doral, other than the Trademarks licensed
under the Assigned Contracts, and (iv) all other Trademarks owned or licensed by Seller and its
Affiliates.
Supply Agreement shall mean the Supply Agreement to be executed concurrently herewith by
Seller and Purchaser, substantially in the form attached hereto as Exhibit B.
Tax shall mean all Federal, state, local and foreign taxes and assessments, including all
interest, penalties and additions with respect thereto.
Tax Return shall mean any report, return, election, notice, estimate, declaration,
information statement and other forms and documents (including all schedules, exhibits and other
attachments thereto) relating to and filed or required to be filed with a taxing authority in
connection with any Taxes (including estimated Taxes).
Territory shall mean The United States of America and its territories and possessions
(including without limitation Puerto Rico).
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Third Party Claim shall have the meaning given such term in Section 10.4(b).
Trademarks shall mean all trademarks, service marks, trade names, service names, brand
names, logotypes, symbols, service marks, Internet domain names and the goodwill of the business
symbolized thereby, including registrations and applications for registrations thereof and all
renewals, modifications and extensions thereof.
ARTICLE II. SALE AND PURCHASE OF PURCHASED ASSETS
Section 2.1. Purchase and Sale. Upon the terms and subject to the
conditions of this Agreement, Seller hereby sells, assigns, transfers, conveys and delivers to
Purchaser, and Purchaser hereby purchases, acquires and accepts, all right, title and interest,
within the Territory, of Seller in, to and under the Purchased Assets.
Section 2.2. Purchased Assets. (a) The term Purchased Assets shall mean
the following properties, assets and rights of whatever kind and nature, tangible or intangible,
other than the Excluded Assets, of Seller existing on the Closing Date:
(i) the Product Intellectual Property;
(ii) the NDA;
(iii) copies of the existing lists of all current customers for Doral and the
pricing of Doral for such customers; provided, however, that Seller shall retain
all rights of access and ownership of such information with respect to sales of other products of
Seller or its Affiliates;
(iv) the Assigned Contracts;
(v) the Product Marketing Materials;
(vi) copies of Product Medical Materials;
(vii) copies of the following: Sellers files pertaining to the NDA, annual
reports relating to the NDA which are filed with the FDA, correspondence with the FDA, validation
documents and data, to the extent such information is within the possession of Seller on the
Closing Date, sales histories and quality control histories pertaining to Doral, in each case only
to the extent it relates to Doral and is in existence and in the possession of Seller as of the
Closing Date;
(viii) the Product Inventory; and
(ix) all unfilled customer orders for Doral as of the Closing (a list of such
orders to be provided to Purchaser within ten (10) Business Days after the Closing) (Customer
Orders); it being understood and agreed that all of such Customer Orders as of the Closing shall
be unfilled in their entirety.
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(b) Seller and Purchaser expressly agree and acknowledge that the Purchased Assets
shall not include any of the following (the Excluded Assets):
(i) the Excluded Intellectual Property;
(ii) any plant, tangible property (other than the Product Inventory, documents or
other tangible records embodying intangible property listed in Section 2.2(a)(i) through (ix)
above), or equipment or employees related to the development, manufacture and commercialization of
Doral;
(iii) any bulk tablet, Compound or other raw material or packaging component inventory;
and
(iv) all other tangible and intangible assets of Seller and its Affiliates not expressly
set forth in Section 2.2(a).
(c) Purchaser acknowledges and agrees that Seller may retain for archival purposes
and for purposes of complying with Governmental Rules and the Supply Agreement one physical copy
(along with electronic archival copies) of all or any part of the documentation or other materials
that it delivers to Purchaser hereunder.
Section 2.3. Assumption of Certain Losses and Obligations. (a) Purchaser
hereby assumes, is responsible for and hereby agrees to pay, perform and discharge when due all
Losses (including any Losses arising in respect of Taxes) arising from the ownership, possession
and/or use after the Closing of the Purchased Assets by Purchaser, its Affiliates, successors or
assigns and the sale of Doral by Purchaser, its Affiliates, successors or assigns including: (i)
any Losses arising from any product liability or patent or trademark infringement claim or lawsuit
brought by any third party, the FDA or any other Governmental Entity with respect to the activities
of, or sales of Doral by, Purchaser, its Affiliates, successors or assigns after the Closing, (ii)
any Losses arising from any FDA or any other Governmental Entity action or notification with
respect to the activities of, or sales of Doral by, Purchaser, its Affiliates, successors or
assigns after the Closing, (iii) any Losses under the Assigned Contracts and the Assumed
Contractual Obligations arising or resulting from events, occurrences or circumstances after the
Closing and (iv) any Losses arising under Customer Orders (collectively, the Assumed
Liabilities). However, Purchasers and Sellers obligations are, with respect to Product
Inventory and other Doral purchased by Purchaser under the Supply Agreement, subject to Section 2.7
of the Supply Agreement. Each of the parties hereto acknowledges that the foregoing does not alter
or impair any rights or obligations that the parties may have under the Supply Agreement.
(b) Except for the Assumed Liabilities or as otherwise expressly set forth in this
Agreement, Purchaser shall not assume or be liable for any Losses arising in connection with Doral,
the Assigned Contracts or the other Purchased Assets to the extent any such Liability arises with
respect to the activities of, or sales of Doral by, Seller or its Affiliates on or prior to the
Closing (collectively, the Excluded Liabilities).
Section 2.4. Proration. Seller and Purchaser agree to prorate as of the
Closing Date any amounts under the Assigned Contracts which become due and payable after the
Closing
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Date to the extent the benefit is attributable to the period on or prior to the Closing Date,
and any amounts under the Assigned Contracts which are paid prior to the Closing Date to the extent
the benefit is attributable to the period subsequent to the Closing Date.
ARTICLE III. PURCHASE PRICE
Section 3.1. Purchase Price. The purchase price for the Purchased Assets
shall be Four Million Dollars ($4,000,000) in cash (the Purchase Price), payable in accordance
with Sections 4.2 and 4.3.
Section 3.2. Allocation of Purchase Price. Purchaser and Seller agree to
report (and to cause its Affiliates to report) for tax purposes, the allocation of the Purchase
Price in accordance with Code Section 1060 as set forth in Exhibit C, and agrees not to take any
position inconsistent therewith in any Tax Return, in any Tax refund claim or in any Tax related
litigation.
Section 3.3. Transfer Taxes.
(a) Subject to Section 3.3(b), Seller shall be responsible for all sales, transfer and
other similar Taxes assessed by the State of New Jersey payable in connection with the transactions
contemplated hereby. Purchaser shall be responsible for all sales, transfer and other similar
Taxes assessed by the State of California payable in connection with the transactions contemplated
hereby. All payments shall be made hereunder without deduction or set-off for any taxes, levies,
fees, withholdings or other charges imposed on Purchaser.
(b) Purchaser is claiming a sales and use tax exemption for the State of New Jersey, and will
obtain within a commercially reasonable time after the Closing Date a Tax Exempt Certificate from
the State of New Jersey Division of Taxation. Purchaser agrees to indemnify and hold harmless
Seller from any and all sales and use taxes levied or otherwise assessed by the State of New Jersey
on the Seller resulting from or arising out of the Purchasers failure to obtain such Tax Exempt
Certificate. Seller shall cooperate with Purchaser as reasonably requested by Purchaser to
complete such Tax Exempt Certificate.
ARTICLE IV. THE CLOSING; POST-CLOSING PAYMENT
Section 4.1. Closing Date. The closing of the sale and transfer of the
Purchased Assets (hereinafter called the Closing) shall take place at the offices of Stradling
Yocca Carlson & Rauth, 600 Newport Center Drive, Newport Beach, CA 92660 on the date of this
Agreement (such date of the Closing being hereinafter referred to as the Closing Date). The
Closing shall be effective as of the close of business (California time) on the Closing Date.
Section 4.2. Transactions to Be Effected at the Closing. At the Closing:
Seller shall deliver or cause to be delivered to Purchaser each of the items referred to in Section
9.1, in each case appropriately executed; and Purchaser shall deliver or cause to be delivered to
Seller (i) each of the items referred to in Section 9.2, in each case appropriately executed, and
(ii) nonrefundable payment of Two Million Five Hundred Thousand Dollars ($2,500,000) of the
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Purchase
Price by wire transfer in immediately available funds to the bank account or
accounts designated in writing by Seller prior to the Closing Date.
Section 4.3. Post Closing Payment. Purchaser shall pay Seller the
remaining nonrefundable payment of One Million Five Hundred Thousand Dollars ($1,500,000) of the
Purchase Price, without interest thereon, within forty-five (45) days of Purchasers receipt of
written notification from the FDA of the FDAs approval for an alternative source to manufacture
and supply Quazepam for Doral under the NDA (FDA Notification). The parties agree to use their
best commercial efforts to obtain such approval for an alternative source. If Purchaser fails to
pay such amount specified under this Section within forty-five (45) days of Purchasers receipt of
FDA Notification, Purchaser shall and hereby does assign all right, title and interest in, to and
under the Purchased Assets back to Seller. Purchaser agrees to promptly execute and deliver any
additional documentation which may be reasonably required at any time to effectuate the
reassignment of the Purchased Assets to Seller, including providing the FDA with notification of,
and documentation necessary to evidence, the reassignment of the Purchased Assets.
Section 4.4. Transfer of Product Inventory. The Product Inventory
purchased by Purchaser hereunder will be delivered to Purchaser pursuant to the terms and
conditions of Section 2.7 of the Supply Agreement.
ARTICLE V. REPRESENTATIONS AND WARRANTIES OF SELLER
Seller hereby represents and warrants to Purchaser as follows:
Section 5.1. Sellers Organization; Good Standing. Seller is a
corporation, duly organized, validly existing and in good standing under the laws of the
jurisdiction of its incorporation. Seller has the requisite power and authority to own the
Purchased Assets and to carry on its business as currently conducted. Seller is duly qualified to
conduct business as a foreign corporation and is in good standing in every jurisdiction where the
nature of the business conducted by it makes such qualification necessary, except where the failure
to so qualify or be in good standing would not have a Material Adverse Effect.
Section 5.2. Authority; Execution and Delivery. Seller has the requisite
corporate power and authority to enter into this Agreement and to consummate the transactions
contemplated hereby. The execution and delivery of this Agreement by each individual entity
constituting Seller and the consummation of the transactions contemplated hereby have been duly and
validly authorized. This Agreement has been duly executed and delivered by Seller and, assuming
the due authorization, execution and delivery of this Agreement by Purchaser, constitutes the
legal, valid and binding obligation of such entity, enforceable against it in accordance with its
terms, subject to general principles of equity, including principles of commercial reasonableness,
good faith and fair dealing (regardless of whether enforcement is sought in a proceeding at law or
in equity).
Section 5.3. Consents; No Violation, Etc. The execution and delivery of
this Agreement do not, and the consummation of the transactions contemplated hereby and the
8
compliance with the terms hereof will not (i) violate any Governmental Rule applicable to
Seller or the Purchased Assets, (ii) conflict with any provision of the certificate of
incorporation or by-laws of Seller, (iii) conflict with any Assigned Contract (provided that
consent of IVAX Research, Inc. is required thereunder), or (iv) require any approval,
authorization, consent, license, exemption, filing or registration with any court, arbitrator or
Governmental Entity, except, with respect to the foregoing clauses (i) and (iii), for such
violations or conflicts which would not have a Material Adverse Effect or materially interfere with
Sellers performance of its obligations hereunder or, with respect to the foregoing clause (iv),
for such approvals, authorizations, consents, licenses, exemptions, filings or registrations (a)
with the FDA, (b) which have been obtained or made or (c) which, if not obtained or made, would not
have a Material Adverse Effect or materially interfere with Sellers performance of its obligations
hereunder.
Section 5.4. Title to Purchased Assets. Seller has good and valid title
to all of the Purchased Assets, free and clear of all Encumbrances other than Permitted
Encumbrances. Seller and its Affiliates are not parties to any contracts, agreements or
obligations of any nature that provide any third party with the right to acquire any of the
Purchased Assets (other than Product Inventory in the ordinary course).
Section 5.5. Inventory. The identity, amounts and expiry dating of the
Product Inventory are set forth in Schedule 5.5. The representations and warranties of
Seller in Section 5.1 of the Supply Agreement are incorporated by reference herein.
Section 5.6. Litigation. There is no suit, claim, action, investigation
or proceeding pending against Seller or, to the Knowledge of Seller, threatened against Seller,
that relates to the Purchased Assets which (i) if adversely determined would result in a Material
Adverse Effect or (ii) challenges or seeks to prevent or enjoin the transactions contemplated by
this Agreement.
Section 5.7. Product Sales, Returns, Pipeline. The sales and returns
reports for the Product for the period from January, 2003 to April, 2006, attached as Schedule
5.7, are a complete and accurate report on all sales and returns of Doral for the period shown.
There does not exist as of the date hereof more than three (3) months of supply of Doral in the
distribution channels (of Seller or its distributors or customers) for Doral, assuming sales and
return levels consistent with those set forth in Schedule 5.7.
Section 5.8. Assigned Contracts . To the best of Sellers
knowledge, each of the Assigned Contracts is in full force and effect. Seller is not, and has not
received notice that it is, or will by the passage of time be, in breach or default of the Assigned
Contracts. To the knowledge of Seller, the other party to the Assigned Contracts is not in breach
or default thereof.
ARTICLE VI. CERTAIN COVENANTS AND AGREEMENTS OF SELLER
Section 6.1. Post-Closing Orders and Payments. From and for two months
after the Closing Date, Seller shall: (i) promptly deliver to Purchaser any purchase orders for
Doral received after the Closing and any payments received from third parties for Doral
9
purchased from Purchaser after the Closing, and (ii) refer all inquiries it shall receive with
respect to Doral in the Territory (other than with respect to Excluded Assets or Excluded
Liabilities), to Purchaser or its designee.
Section 6.2. Notification of Customers. Each of Purchaser and Seller
shall promptly notify its direct customers (including wholesalers) after the Closing Date in forms
of letter to be agreed upon, that Purchaser has acquired and Seller has transferred the right to
market, distribute and sell Doral in the Territory.
Section 6.3. Freedom from Suit. To the extent Purchaser or its Affiliates
or any of their respective successors or assigns manufactures, distributes, markets and sells
Doral, or its generic equivalents, using the Purchased Assets in the same manner and to the same
extent that Seller has done so prior to the Closing Date, Seller hereby waives, and hereby ensures
that Sellers Affiliates waive, any right, remedy or cause of action that they may have against
Purchaser, such Affiliates, successors or assigns based on infringement or misappropriation of
intellectual property or other proprietary rights of Seller or such Affiliates arising or resulting
from such manufacture, distribution, marketing and sale by Purchaser, such Affiliates, successors
or assigns, regardless of whether such rights are included in any of the Purchased Assets.
Section 6.4. Financial Statements. To the extent required by the rules
and regulations of the U.S. Securities and Exchange Commission (the SEC), Seller will deliver to
Purchaser as hereinafter specified at Purchasers sole expense, audited statements of assets
acquired, liabilities assumed, revenue and expenses with respect to Doral for the required periods
which are compliant with the rules and regulations of the SEC (the Financial Statements). An
independent certified public accountant will perform the audit of the Financial Statements at
Purchasers sole expense. Seller will deliver the Financial Statements at a mutually agreeable
time that shall be within sixty (60) days of the Purchasers written request of the Financial
Statements; provided that such request is made by Purchaser within twelve (12) months of the
Closing Date.
ARTICLE VII. REPRESENTATIONS AND WARRANTIES OF PURCHASER
Purchaser hereby represents and warrants to Seller as follows:
Section 7.1. Purchasers Organization; Good Standing. Purchaser is a
corporation duly organized, validly existing and in good standing under the laws of the State of
California. Purchaser has all requisite corporate power and authority to carry on its business as
it is currently being conducted. Purchaser is duly qualified to conduct business as a foreign
corporation and is in good standing in every jurisdiction where the nature of the business
conducted by it makes such qualification necessary, except where the failure to so qualify or be in
good standing would not have a material adverse effect on Purchaser or its ability to perform its
obligations hereunder.
Section 7.2. Authority; Execution and Delivery. Purchaser has the
requisite corporate power and authority to enter into this Agreement and to consummate the
transactions contemplated hereby. The execution and delivery of this Agreement by Purchaser and
the consummation of the transactions contemplated hereby have been duly and validly authorized.
This Agreement has been duly executed and delivered by Purchaser and, assuming the due
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authorization, execution and delivery of this Agreement by Seller, constitutes the legal,
valid and binding obligation of Purchaser, enforceable against Purchaser in accordance with its
terms, subject to general principles of equity, including principles of commercial reasonableness,
good faith and fair dealing (regardless of whether enforcement is sought in a proceeding at law or
in equity).
Section 7.3. Consents; No Violations, Etc. The execution and delivery of
this Agreement do not, and the consummation of the transactions contemplated hereby and the
compliance with the terms hereof will not (i) violate any Governmental Rule applicable to
Purchaser, (ii) conflict with any provision of the articles of incorporation or bylaws of
Purchaser, (iii) conflict with any material Contract to which Purchaser is a party or by which it
is otherwise bound or (iv) require any approval, authorization, consent, license, exemption, filing
or registration with any court, arbitrator or Governmental Entity, except with respect to the
foregoing clauses (i) and (iii), for such violations or conflicts which would not materially
interfere with Purchasers performance of its obligations hereunder or, with respect to the
foregoing clause (iv), for such approvals, authorizations, consents, licenses, exemptions, filings
or registrations which have been obtained or made or which, if not obtained or made, would not
materially interfere with Purchasers performance of its obligations hereunder.
ARTICLE VIII. CERTAIN COVENANTS AND AGREEMENTS
Section 8.1. Transferred Documentation. Notwithstanding anything to the
contrary contained herein, Seller shall deliver to Purchaser any documents and other materials
included in the Purchased Assets that are in Sellers possession at the Closing as promptly as
practicable after the Closing Date, but no later than fifteen (15) days after the Closing Date;
provided, however, that, notwithstanding anything herein to the contrary, with respect to Periodic
Adverse Drug Experience Reports and Annual Reports (the Reports) of Seller, Seller shall deliver
to Purchaser copies of only those Reports that Seller can locate using commercially reasonable
efforts.
Section 8.2. Confidentiality. The provisions of the Confidential
Disclosure Agreement, dated as of December 14, 2005, by and between Purchaser and Seller (the
Confidentiality Agreement) shall apply to any information disclosed to Purchaser pursuant to this
Agreement, or otherwise in connection with the transactions contemplated hereby, provided that
confidential information of Seller disclosed thereunder shall, after the Closing, be deemed
confidential information of Purchaser.
Section 8.3. Trade Returns, Medicaid Rebates, Chargebacks. (a) Purchaser
shall not use Sellers name or NDC number in connection with the sale of Doral after the Closing,
and agrees to overlabel Doral with new labels containing Purchasers NDC number prior to selling
any Doral after the Closing. Seller shall be financially responsible for all returns, rebates and
chargeback claims that relate to Doral sold prior to Closing. Purchaser shall be financially
responsible for returns, rebates and chargeback claims relating to Doral sold following Closing.
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(b) All returned Doral received by Seller bearing Purchasers NDC Number after the
Closing shall be forwarded to Purchaser.
Section 8.4. Adverse Experience Reports. For a period of one (1) year
after the Closing Date, Seller shall submit to Purchaser all adverse drug experience information
brought to the attention of Seller or its Affiliates in respect of Doral as well as any material
events and matters concerning or affecting the safety of Doral. Additionally, after the Closing
Date, and subject to the Supply Agreement, Seller shall assist Purchaser with the provision of data
relating to adverse experiences for Doral for Purchasers preparation of its first Periodic Adverse
Drug Experience Report after the Closing Date. After the Closing Date, Purchaser shall have sole
responsibility for investigating and reporting adverse experiences for Doral and addressing any FDA
inquiries relating to the safety of Doral.
Section 8.5. Product Complaints and Inquires. For a period of six (6)
months after the Closing Date, and subject to the Supply Agreement, Seller shall provide reasonable
assistance to Purchaser with Doral product complaints and inquires received by Purchaser.
Section 8.6. Transfer of NDA, Etc. (a) For the period from the Closing
Date through one (1) year thereafter and subject to Section 8.1, Seller shall cooperate with
Purchaser in disclosing and copying any relevant records and reports which are required to be made,
maintained and reported pursuant to Governmental Rules in the Territory. The parties agree to use
their reasonable efforts to take any other actions required by the FDA to effect the transactions
contemplated hereby. Promptly after the Closing Date, each of the parties hereto shall take any
actions necessary to effect the transfer of the NDA from Seller to Purchaser, including notices to
the FDA regarding such transfer from Seller to Purchaser of the NDA substantially in the form
attached hereto as Exhibit E. Seller shall also provide commercially reasonable assistance to
Purchaser in the preparation of first Annual Report due after the Closing Date. Additionally, the
Seller shall draft and provide to the Purchaser the entire portion of the Annual Report covering
the dates from the beginning of the annual reporting year prior to the Closing Date through the
Closing Date. Seller shall be responsible for all costs related to any activities required to be
performed to under this Section 8.6.
(b) Upon the terms and subject to the conditions hereof, each of Seller and
Purchaser shall use its commercially reasonable efforts to (i) take, or cause to be taken, all
actions necessary, proper or advisable under applicable Governmental Rules and consummate and make
effective the transactions contemplated by this Agreement, (ii) obtain from the requisite
Governmental Entities any consents, licenses, permits, waivers, approvals, authorizations or orders
required to be obtained or made in connection with the authorization, execution and delivery of
this Agreement and the consummation of the transactions contemplated by this Agreement and (iii)
make all necessary filings, and thereafter make any other advisable submissions, with respect to
this Agreement and the transactions contemplated by this Agreement required under any other
applicable Governmental Rules. The parties hereto shall cooperate with each other in connection
with the making of all such filings, including by providing copies of all such non-confidential
documents to the other party hereto and its advisors prior to filing and, if requested, by
accepting all reasonable additions, deletions or changes suggested in connection therewith. Seller
and Purchaser each shall furnish all information required for any application or other filing to be
made pursuant to the rules and regulations of
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any applicable Governmental Rules in connection with the transactions contemplated by this
Agreement.
Section 8.7. Response to Medical Inquiries and Product Complaints. After
the Closing, Purchaser shall assume all of Sellers responsibility for responding to any medical
inquiries or complaints about Doral. For a period of three (3) months from the Closing Date,
Seller shall provide commercially reasonable assistance in responding to such inquiries or
complaints.
Section 8.8. Noncompetition. (a) For a period of ten (10) years following
the Closing Date (the Non-Competition Period), Seller shall not, without the prior written
consent of Purchaser, directly or through intermediaries, develop, sell, market, distribute or
manufacture for sale, anywhere in the Territory, any Quazepam-containing pharmaceutical product, or
actively and knowingly assist any third party to do any of the foregoing (collectively, Seller
Restricted Activities); provided, however, that nothing herein shall prevent Seller or its
Affiliates from selling Doral to Purchaser pursuant to the Supply Agreement. For purposes of this
Section 8.8(a), any act or activity undertaken by any Affiliate of Seller which, if undertaken by
Seller, would breach this Section 8.8(a), shall constitute a breach of this Section 8.8(a).
(b) Nothing contained in this Section 8.8 shall be construed as prohibiting Seller
or any of its Affiliates from: (i) acquiring (whether by merger, asset or stock acquisition or
otherwise) any company, business or line of products (including by license thereof or through
investment therein); (ii) entering into any joint venture, alliance or other similar collaborative
arrangement between Seller or an Affiliate thereof and any third party or (iii) acquiring or owning
through a mutual fund, employee benefit plan, trust account, or similar investment pool or vehicle,
any class of securities of any Person regardless of whether such entity engages in Seller
Restricted Activities. However, if Seller or an Affiliate makes such an acquisition or enters into
such a joint venture, alliance or other similar collaborative arrangement, Seller or such Affiliate
shall divest that portion, if any, of the business acquired or which such third party brings to
such arrangement and which would otherwise violate this Section 8.8 (the Competing Acquired
Business), within one (1) year of such acquisition, or entering into such arrangement. At any
time Purchaser shall be entitled to request that Seller inform Purchaser of the status of the
efforts to divest the Competing Acquired Business. Upon such request, Seller shall promptly
provide Purchaser with a written notification setting forth in reasonable detail the efforts
undertaken with respect to such divestiture.
(c) For the avoidance of doubt, upon the consummation of any transaction that
results in a change of control of Seller, the restrictions set forth in this Section 8.8 shall
apply only to Seller and its controlled Affiliates but not to any other Affiliate of Seller,
including a Person obtaining control of Seller in such change of control transaction (such Person
and such non-controlled Affiliates of Seller, collectively the Seller Acquiring Entity);
provided, however, that to the extent the Seller Acquiring Entity is engaged in Seller Restricted
Activities, the Seller Acquiring Entity shall not be allowed any access to any competitively
sensitive proprietary and confidential information that pertains to the Purchased Assets.
(d) Seller acknowledges and agrees that (i) the covenants contained in this
Section 8.8 are incident to the purchase and sale of the Purchased Assets and are an important
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part of the consideration to be received by Purchaser in exchange for the consideration paid
by Purchaser pursuant hereto; and (ii) that the Purchaser is relying on the covenants contained in
this Section 8.8 in its decision to enter into this Agreement and purchase the Purchased Assets.
(e) Each of the provisions of this Section 8.8 shall be construed as an agreement
independent of any other provision contained in this Section 8.8 or elsewhere in this Agreement,
and the restrictions herein with respect to each of the States in the United States shall be an
agreement independent of the restrictions with respect to the other States or other countries, and
each provision (and the restrictions with respect to each such state or country) shall be
enforceable in both law and equity, including by temporary or permanent restraining orders or
injunctions, notwithstanding the existence of any claim or cause of action Seller may have or claim
against Purchaser, whether predicated on this Agreement or otherwise. In the event any provision
of this Section 8.8 or the restrictions with respect the conduct that constitutes competition, to
any one or more States or countries, or the time period of the restrictions, are held to be invalid
or overbroad, then such provisions, States or countries shall be modified, reduced, or deleted if
deemed appropriate, by the applicable court such that the remainder of this Section 8.8, restricted
conduct, the States and countries included in the restricted territory, and the time period, as
thus modified shall remain in full force and effect.
ARTICLE IX. CLOSING DELIVERABLES
Section 9.1. Seller Deliverables. Seller shall execute and deliver to
Purchaser (i) a Bill of Sale and Assignment substantially in the form of Exhibit D hereto,
and (ii) a counterpart of the Supply Agreement.
Section 9.2. Purchaser Deliverables. Purchaser shall pay $2,500,000 and
execute and deliver to Seller a counterpart of the Supply Agreement.
ARTICLE X. SURVIVAL OF REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
Section 10.1. Survival. All representations and warranties of Seller and
Purchaser contained herein or made pursuant hereto shall survive the
Closing Date for a
period of one (1) year after the Closing Date. The covenants and agreements of the parties
contained in this Agreement shall survive and remain in full force for the applicable periods
described therein or, if no such period is specified, (i) indefinitely for Articles II-IV, Section
6.3, Section 8.2 and Section 8.3 (first sentence) and (i) for no longer than one year after the
Closing Date for all other Articles. Any right of indemnification pursuant to Article X hereof
with respect to a claimed breach of a (i) representation or warranty shall expire at the date of
termination of the representation or warranty claimed to be breached, and (ii) covenant shall
expire one (1) year after the date of termination of the covenant claimed to be breached, unless in
both cases on or prior to such date the party from whom indemnification is sought shall have
received notice in accordance with the provisions of Section 10.6 hereof. By way of clarification,
there shall be no time limit, other than the applicable statute of limitations, for indemnification
claims brought by Seller arising from any Assumed Liability and by Purchaser arising from any
Excluded Liability.
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The provisions of this Section 10.1 shall survive for so long as any other Section of this
Agreement shall survive.
Section 10.2. Indemnification by Seller. Seller hereby agrees to
indemnify Purchaser and its Affiliates and their respective officers, directors and employees (the
Purchaser Indemnified Parties) against, and agrees to hold them harmless from, any Loss to the
extent such Loss arises from or in connection with the following:
(i) any breach by Seller of any representation or warranty contained in this
Agreement;
(ii) any breach by Seller of any of its covenants contained in this Agreement; or
(iii) any Excluded Liability.
Section 10.3. Indemnification by Purchaser. Purchaser hereby agrees to
indemnify Seller and its Affiliates and their respective officers, directors and employees (the
Seller Indemnified Parties) against, and agrees to hold them harmless from, any Loss to the
extent such Loss arises from or in connection with the following:
(i) any breach by Purchaser of any representation or warranty contained in this
Agreement;
(ii) any breach by Purchaser of any covenant contained in this Agreement; or
(iii) any Assumed Liability.
Section 10.4. Procedure. (a) In order for an indemnified party under this
Article X (an Indemnified Party) to be entitled to any indemnification provided for under this
Agreement, such Indemnified Party shall, promptly following the discovery of the matters giving
rise to any Loss, notify the indemnifying party under this Article X (the Indemnifying Party) in
writing of its claim for indemnification for such Loss, specifying in reasonable detail the nature
of such Loss and the amount of the liability estimated to accrue therefrom; provided, however, that
failure to give such prompt notification shall not affect the indemnification provided hereunder
except to the extent the Indemnifying Party shall have been actually prejudiced as a result of such
failure (except that the Indemnifying Party shall not be liable for any expenses incurred during
the period in which the Indemnified Party failed to give such notice). Thereafter, the Indemnified
Party shall deliver to the Indemnifying Party, within five Business Days after the Indemnified
Partys receipt of such request, all information and documentation reasonably requested by the
Indemnifying Party with respect to such Loss.
(b) If the indemnification sought pursuant hereto involves a claim made by a third
party against the Indemnified Party (a Third Party Claim), the Indemnifying Party shall be
entitled to participate in the defense of such Third Party Claim and, if it so chooses, to assume
the defense of such Third Party Claim with counsel selected by the Indemnifying Party. Should the
Indemnifying Party so elect to assume the defense of a Third Party Claim, the Indemnifying
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Party shall not be liable to the Indemnified Party for any legal expenses subsequently
incurred by the Indemnified Party in connection with the defense thereof. If the Indemnifying
Party assumes such defense, the Indemnified Party shall have the right to be represented in the
defense thereof and to employ counsel, at its own expense, separate from the counsel employed by
the Indemnifying Party, it being understood that the Indemnifying Party shall control such defense.
The Indemnifying Party shall be liable for the reasonable fees and expenses of counsel employed by
the Indemnified Party for any period during which the Indemnifying Party has not assumed the
defense thereof (other than during any period in which the Indemnified Party shall have failed to
give notice of the Third Party Claim as provided above). If the Indemnifying Party chooses to
defend or prosecute a Third Party Claim, the other party hereto shall cooperate in the defense or
prosecution thereof. Such cooperation shall include the retention and (upon the Indemnifying
Partys request) the provision to the Indemnifying Party of records and information which are
reasonably relevant to such Third Party Claim, and making employees available on a mutually
convenient basis to provide additional information and explanation of any material provided
hereunder. If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the
Indemnified Party will agree to any settlement, compromise or discharge of such Third Party Claim
which the Indemnifying Party may recommend and which by its terms (i) obligates the Indemnifying
Party to pay the full amount of the liability in connection with such Third Party Claim, (ii)
includes a full release in favor of the Indemnified Party with respect to the Third Party Claim,
does not include any admission of liability and contains reasonable provisions maintaining the
confidentiality of the settlement, compromise or discharge, and (iii) does not impair the rights of
the Indemnified Party. Whether or not the Indemnifying Party shall have assumed the defense of a
Third Party Claim, the Indemnified Party shall not admit any liability with respect to, or settle,
compromise or discharge, such Third Party Claim without the Indemnifying Partys prior written
consent, which will not be unreasonably withheld or delayed.
Section 10.5. Certain Limitations on Indemnification. Notwithstanding
anything to the contrary contained herein, in no event shall the aggregate indemnification to paid
by Seller or Purchaser hereunder exceed the Purchase Price.
ARTICLE XI. GENERAL PROVISIONS
Section 11.1. Amendments and Waivers. This Agreement may not be amended,
modified, superseded or canceled except by an instrument in writing signed on behalf of each of the
parties hereto, and this requirement may not itself be waived except by such a writing signed by
both parties hereto. No breach of any provision of this Agreement can be waived unless in writing,
but by an instrument in writing, Purchaser, on the one hand, or Seller, on the other hand, may
waive compliance by the other party with any term or provision of this Agreement that such other
party was or is obligated to comply with or perform. Waiver of any one breach shall not be deemed
to be a waiver of any other breach of the same or any other provision hereof.
Section 11.2. Expenses. Except as otherwise specified in this Agreement,
all costs and expenses, including fees and disbursements of counsel, financial advisors and
accountants, incurred in connection with this Agreement and the transactions contemplated hereby
shall be paid by the party incurring such costs and expenses, whether or not the Closing shall have
occurred.
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Section 11.3. Further Assurances and Actions. Each of the parties hereto,
upon the request of the other party hereto, whether before or after the Closing and without further
consideration, shall use commercially reasonable efforts to do, execute, acknowledge and deliver or
cause to be done, executed, acknowledged or delivered all such further acts, deeds, documents,
assignments, transfers, conveyances, powers of attorney and assurances as may be reasonably
necessary to effect complete consummation of the transactions contemplated by this Agreement.
Seller and Purchaser each agree to execute and deliver such other documents, certificates,
agreements and other writings and to use commercially reasonable efforts to take such other actions
as may be reasonably necessary in order to consummate or implement expeditiously the transactions
contemplated by this Agreement.
Section 11.4. Notices. All notices, requests and other communications
hereunder shall be in writing and shall be sent, delivered or mailed, addressed as follows:
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(a)
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if to Purchaser, to: |
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Questcor Pharmaceuticals, Inc. |
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3260 Whipple Road |
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Union City, California 94587 |
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Telephone: (510) 400-0735 |
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Telecopy: (510) 400-0710 |
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Attention: Steve Cartt |
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with a copy to: |
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Stradling Yocca Carlson & Rauth |
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660 Newport Center Drive, Suite 1600 |
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Newport Beach, California 92660 |
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Telephone: (949) 725-4000 |
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Telecopy: (949) 725-4100 |
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Attention: Michael H. Mulroy |
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(b)
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if to Seller, to: |
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MedPointe Healthcare Inc. |
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265 Davidson Avenue |
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Somerset, NJ 08873-4120 |
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Telephone: (732) 564-2200 |
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Telecopy: (732) 564-2210 |
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Attn: General Counsel |
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with a copy to: |
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Weil, Gotshal & Manges LLP |
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767 Fifth Avenue |
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New York, NY 10153 |
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Telecopy: (212) 310-8007 |
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Attention: Sandra Bresnick, Esq. |
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or to such other addresses as any party hereto shall notify the other party hereto (as provided
above) from time to time.
Each such notice, request or other communication shall be given (i) by hand delivery, (ii) by
certified mail or (iii) by nationally recognized courier service. Each such notice, request or
communication shall be effective when delivered at the address specified in this Section 11.4 (or
in accordance with the latest unrevoked direction from the receiving party).
Section 11.5. Interpretation. This Agreement shall be deemed drafted
jointly by all the parties hereto and shall not be specifically construed against any party hereto
based on any claim that such party or its counsel drafted this Agreement. Interpretation of this
Agreement shall be governed by the following rules of construction: (a) words in the singular
shall be held to include the plural and vice versa and words of one gender shall be held to include
the other gender as the context requires, (b) references to the terms Article, Section, and
Schedule are references to the Articles, Sections, Paragraphs, and Schedules to this Agreement
unless otherwise specified, (c) the word including and words of similar import shall mean
including, without limitation, (d) provisions shall apply, when appropriate, to successive events
and transactions, and (e) the table of contents and headings contained in this Agreement are for
reference purposes only and shall not affect in any way the meaning or interpretation of this
Agreement.
Section 11.6. Severability. If any term or other provision of this
Agreement is invalid, illegal or incapable of being enforced under any law or public policy, all
other terms and provisions of this Agreement shall nevertheless remain in full force and effect so
long as the economic or legal substance of the transactions contemplated hereby is not affected in
any manner materially adverse to any party. Upon such determination that any term or other
provision is invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in
good faith to modify this Agreement so as to effect the original intent of the parties as closely
as possible in an acceptable manner in order that the transactions contemplated hereby are
consummated as originally contemplated to the greatest extent possible.
Section 11.7. Counterparts. This Agreement may be executed in one or more
counterparts, all of which shall be considered one and the same agreement and shall become
effective when one or more counterparts have been signed by each of the parties and delivered to
the other parties, it being understood that all parties need not sign the same counterpart.
Section 11.8. Entire Agreement; No Third Party Beneficiaries. This
Agreement, the Supply Agreement and the Confidentiality Agreement constitute the entire agreement
and supersede all prior or contemporaneous negotiations, agreements and understandings, whether
written, oral or implied, between or among the parties hereto with respect to the subject matter
hereof, and no other representation, warranty, condition, understanding or agreement of any kind
with respect to the subject matter hereof or thereof has been or shall be relied on by the parties
hereto. Except as specifically provided herein or therein, such agreements are not intended to
confer upon any Person other than the parties hereto any rights or remedies hereunder or
thereunder.
18
Section 11.9. Governing Law; Venue. This Agreement, including the
validity, enforceability and interpretation thereof, shall be governed by and construed in
accordance with the laws of the State of New Jersey, without regard to the conflict of law
principles thereof. Each of the parties hereto irrevocably and unconditionally, for the purposes
of any suit, action or other proceeding arising out of this Agreement or any transaction
contemplated hereby (and each agrees that no such action, suit or proceeding relating to this
Agreement shall be brought by it or any of its Affiliates except in such courts). Each of the
parties hereto further agrees that, to the fullest extent permitted by applicable Law, service of
any process, summons, notice or document by U.S. registered mail to such persons respective
address set forth above shall be effective service of process for any action, suit or proceeding
with respect to any matters to which it has submitted to jurisdiction as set forth above in the
immediately preceding sentence. Each of the parties hereto irrevocably and unconditionally waives
(and agrees not to plead or claim) any objection to the laying of venue of any action, suit or
proceeding arising out of this Agreement or the transactions contemplated hereby in such courts, or
that any such action, suit or proceeding brought in any such court has been brought in an
inconvenient forum.
Section 11.10. Publicity. Neither party shall make any public
announcement concerning, or otherwise publicly disclose, any information with respect to the
transactions contemplated by this Agreement or any of the terms and conditions hereof without the
prior written consent of the other party, which consent shall not be unreasonably withheld.
Notwithstanding the foregoing, either party may make any public disclosure concerning the
transactions contemplated hereby that in the opinion of such partys counsel may be required by law
or the rules of any stock exchange on which such partys or its Affiliates securities trade;
provided that, the party making such disclosure shall provide the non-disclosing party with a copy
of the intended disclosure reasonably, and to the extent practicable, prior to public
dissemination, and the parties shall coordinate with one another, to the extent practicable,
regarding the timing, form and content of such disclosure.
Section 11.11. Assignment. Neither party may assign its rights or
obligations under this Agreement without the prior written consent of the other party; provided,
however, that either party may assign its rights and obligations under this Agreement, without the
prior written consent of the other party, to an Affiliate or to a successor of the relevant portion
of the assigning partys business by reason of merger, sale of all or substantially all of its
assets or any similar transaction, provided that such successor agrees in writing to be bound by
this Agreement. Any permitted assignee shall assume all obligations of its assignor under this
Agreement. No assignment shall relieve either party of its responsibility for the performance of
any obligation. This Agreement shall be binding upon and inure to the benefit of the parties and
their respective successors and permitted assigns.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their
respective representatives thereunto duly authorized, all as of the date first written above.
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MEDPOINTE HEALTHCARE, INC.
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By: |
/s/
BETH HECHT |
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Name: |
Beth Hecht |
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Title: |
Executive Vice President and General Counsel |
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QUESTCOR PHARMACEUTICALS, INC.
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By: |
/s/
STEVE CARTT |
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Name: |
Steve Cartt |
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Title: |
Executive Vice President, Commercial Development |
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20
exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
QUESTCOR ANNOUNCES THE ACQUISITION OF DORAL® (quazepam)
Provides second product for national neurology sales force
Union City, CA May 5, 2006 Questcor Pharmaceuticals, Inc. (AMEX:QSC) today announced the
acquisition of U.S. rights to Doral® (quazepam), a non-narcotic, selective benzodiazepine receptor
agonist that is indicated for the treatment of insomnia, characterized by difficulty in falling
asleep, frequent nocturnal awakenings, and/or early morning awakenings. Questcor is acquiring the
product from MedPointe Inc. for $2.5 million in cash and a future milestone payment of $1.5
million. Gross ex-factory sales for Doral in 2005 were $1.1 million.
Sleep disturbance and insomnia is a very common side effect of many, if not most, neurological
diseases and disorders such as Multiple Sclerosis, Epilepsy, Parkinsons disease, and Alzheimers
disease and is a critical concern of Questcors targeted physicians. We believe that Doral will
complement our efforts to expand the prescribing of our lead product, H.P. Acthar® Gel
(repository corticotropin injection), and will allow Questcor to significantly leverage our forty
person national neurology sales force, said Jim Fares, President and CEO of Questcor.
The U.S. market for sleep medicines has seen significant growth over the past several years and is
estimated to have generated over $3 billion in prescription drug sales in 2005. The prescribing by
Questcors target physicians was estimated at over $100 million in 2005 which was an increase of
nearly 30% from 2004. We believe that Doral has a number of unique properties that make it an
attractive option for the many neurology patients who suffer from sleep disturbance. Doral has
never been promoted directly to neurologists and we believe our national sales force will be able
to capitalize on its attractive therapeutic profile, continued Mr. Fares.
Doral will be the second branded prescription product to be marketed by Questcors national sales
force and further validates Questcors strategy to focus on becoming a leading CNS focused
specialty pharmaceutical company. Questcor expects to re-launch Doral in the third quarter.
Conference Call Questcor will be hosting a conference call to discuss the acquisition of Doral
(quazepam) as well as its results for the first quarter of 2006 on Tuesday, May 9, 2006 at 8:30
a.m. Eastern Time (5:30 a.m. Pacific Time). Please call the following numbers to participate: (800)
741-6056 (domestic) or (706) 679-3280 (international) and use conference ID number 8213744.
Participants are asked to call the above numbers 5-10 minutes prior to the starting time.
This call is being webcast by Thomson/CCBN and can be accessed at Questcors website at
www.questcor.com. The webcast is also being distributed through the Thomson StreetEvents Network
to both institutional and individual investors. Individual investors can listen to the call at
www.earnings.com, Thomson/CCBNs individual investor portal, powered by StreetEvents.
Institutional investors can access the call via Thomsons password-protected event management site,
StreetEvents (www.streetevents.com).
A telephonic replay of this call will be available from 12:00 p.m. Eastern Time on Tuesday, May 9,
2006 through 11:59 p.m. Eastern Time on Tuesday, May 16, 2006. Please call (800) 642-1687
(domestic) or (706) 645-9291 (international) and use conference ID number 8213744.
About Questcor Questcor Pharmaceuticals, Inc.® (AMEX: QSC) is a specialty
pharmaceutical company that develops and commercializes novel therapeutics for the treatment of
neurological disorders. Questcor currently markets H.P. Acthar® Gel (repository
corticotropin injection), an injectable drug indicated for the treatment of exacerbations
associated with Multiple Sclerosis and Doral® (quazepam) that is indicated for the
treatment of insomnia, characterized by difficulty in falling asleep, frequent nocturnal
awakenings, and/or early morning awakenings. For more information, please visit www.questcor.com.
Note: Except for the historical information contained herein, this press release contains
forward-looking statements that involve risks and uncertainties. Such statements are subject to
certain factors, which may cause Questcors results to differ from those reported herein. Factors
that may cause such differences include, but are not limited to, Questcors ability to accurately
forecast and create the demand for its products, the gross margin achieved from the sale of its
products, Questcors ability to enforce its product returns policy, the accuracy of the
prescription data purchased from independent third parties by Questcor, the sell-through by
Questcors distributors, the inventories carried by Questcors distributors, and the expenses and
other cash needs for the upcoming periods, Questcors ability to obtain finished goods from its
sole source contract manufacturers on a timely basis if at all, Questcors potential future need
for additional funding, Questcors ability to utilize its net operating loss carry forwards to
reduce income taxes on the sale of its products, uncertainties regarding Questcors intellectual
property and other research, development, marketing and regulatory risks, and to the ability of
Questcor to implement its strategy and acquire products and, if acquired, to market them
successfully as well as the risks discussed in Questcors annual report on Form 10-K for the year
ended December 31, 2005 and other documents filed with the Securities and Exchange Commission. The
risk factors and other information contained in these documents should be considered in evaluating
Questcors prospects and future financial performance.
Questcor undertakes no obligation to publicly release the result of any revisions to these
forward-looking statements, which may be made to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
Contact:
Eric Liebler, Nisola, LLC
908-437-1320
eliebler@Nisola.com