SPECTRUM PHARMACEUTICALS,
INC.
THIS ASSET PURCHASE AGREEMENT
(this “ Agreement
”), is hereby entered into as of May 6, 2008 (the
“ Execution Date ”), by and between Spectrum
Pharmaceuticals, Inc., a Delaware corporation, with offices located
at 157 Technology Drive, Irvine, California 92618 (the “
Spectrum ”), and Par Pharmaceutical, Inc., a Delaware
corporation having its office at 300 Tice Boulevard, 3rd Floor,
Woodcliff Lake, NJ 07677 (the “ Par ”). Spectrum
and Par may each be referred to herein individually as a “
Party ” and collectively as the “ Parties
.”
WHEREAS , the Parties have previously entered into a
certain Development and Marketing Agreement dated February 22,
2006 (as amended on November 10, 2006 and as further defined
below, the “ Original Agreement ”) related to
certain generic products including products containing sumatriptan
as the active ingredient (as further defined below, the “
Products ”);
WHEREAS , the Parties settled a litigation related to
the Products with Glaxo Group Limited (“ GSK ”)
pursuant to which Spectrum entered into an Agreement with GSK dated
November 10, 2006 (as further defined below, the “
GSK Settlement Agreement ”) and Par entered into a
Supply and Distribution Agreement with GSK dated November 10,
2006 (as further defined below, the “ GSK Supply and
Distribution Agreement ”, and collectively with the GSK
Settlement Agreement, the “ GSK Agreements ”);
and
WHEREAS , Spectrum currently owns or possesses certain
assets and rights related to the Products and the GSK Agreements,
and otherwise related to the drug substance sumatriptan and wishes
to sell those assets and rights to Par, and Par desires to so
acquire those assets and rights; and Spectrum desires to transfer
and assign to Par, and Par desires to assume, certain obligations,
relating to such assets and rights; all upon the terms of this
Agreement.
NOW, THEREFORE , in consideration of the foregoing premises and
of the representations, warranties, covenants and agreements herein
contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, Parties
hereto, intending to be legally bound, agree as follows:
Whenever used in this Agreement, unless
otherwise clearly indicated by the context, the terms defined below
shall have the indicated meanings. Other terms may be defined
elsewhere in the text of this Agreement and, unless otherwise
indicated, shall have such meaning throughout this
Agreement.
1.1. “ Affiliate ” shall mean
with respect to a Party, a Person that controls, is controlled by
or is under common control with a Party. For the purposes of this
definition, the word “control” (including, with
correlative meaning, the terms “controlled by” or
“under common control with”) means the actual power,
either directly or indirectly through one or more intermediaries,
to direct the management and policies of such Person, whether by
the ownership of fifty percent (50%) or more of the voting stock of
such Person (it being understood that the direct or indirect
ownership of a lesser percentage of such stock shall not
necessarily preclude the existence of control), or by contract or
otherwise.
1.2. “ Aggrieved Party ”
shall have the meaning set forth in Section 6.2(a)
.
1.3. “ Agreement” shall have
the meaning set forth in the Preamble.
1.4. “ Applicable Laws ”
shall mean all laws, statutes, regulations, ordinances or the like
of any Governmental Authority having jurisdiction over the
Purchased Assets or the Products or a Party in connection with its
obligations under this Agreement.
1.5. “ Assumed Contracts ”
shall mean the contracts and agreements set forth on
Schedule 1.5 . Such contracts that do not relate
exclusively to Assets are so indicated on Schedule 1.5
.
1.6. “ Assumed Liabilities ”
shall mean the obligations of Spectrum or their Affiliates, as
applicable, under the Assumed Contracts and the Product Regulatory
Files and all liabilities associated with Purchased Assets that
arise on or after the Closing Date, provided ,
however , that “Assumed Liabilities” shall not
include any Excluded Liabilities. Assumed Liabilities shall
specifically include any and all liabilities arising out of
(i) breach by Par and/or its Affiliates of any GSK Agreements
prior to the Closing Date, and/or (ii) the gross negligence or
willful misconduct of Par and/or its Affiliates related to the
Purchased Assets prior to the Closing Date.
1.7. “ Books and Records ”
shall mean all material books and records of Spectrum and its
Affiliates necessary to Manufacture, test, use or sell the Products
and/or Drug Substance.
1.8. “ Business Day ” shall
mean any day other than a Saturday, a Sunday or a day on which
banks in New York City, New York are authorized or obligated by law
or executive order to not open or remain closed.
1.9. “ cGMP Rules ” shall
mean the quality systems and current good manufacturing practices
set forth in 21 C.F.R. (Parts 210 and 211 and Parts 600 and 610 (as
applicable)), and applicable FDA rules and regulations, promulgated
thereunder.
1.10. “ Claim ” shall have
the meaning set forth in Section 6.2(a) .
1.11. “ Closing Date ” shall
mean May 6, 2008.
1.12. “ Confidential Information
” means with respect to a Party (as the “Disclosing
Party”), all non-public information of any kind whatsoever
(including without limitation, data, materials, compilations,
formulae, models, patent disclosures, procedures, processes,
projections, protocols, results of experimentation and testing,
specifications, strategies, techniques and all non-public
intellectual property and know-how), and all tangible and
intangible embodiments thereof of any kind whatsoever (including
without limitation, materials, samples, apparatus, compositions,
documents, drawings, machinery, patent applications, records and
reports), which are disclosed by the Disclosing Party to the other
Party (as the “Receiving Party”) including any and all
copies, replication or embodiments thereof. The Confidential
Information of Par shall also include all non-public information
associated with the Purchased Assets as acquired by Par pursuant to
this Agreement.
2
Notwithstanding
the foregoing, Confidential Information of a Disclosing Party shall
not include information which the Receiving Party can establish by
competent proof (a) to have been publicly known prior to
disclosure of such information by the Disclosing Party to the
Receiving Party, (b) to have become publicly known, without
fault on the part of the Receiving Party, subsequent to disclosure
of such information by the Disclosing Party to the Receiving Party,
(c) to have been received by the Receiving Party free of an
obligation of confidentiality from a source rightfully having
possession of and the right to disclose such information free of an
obligation of confidentiality, (d) to have been otherwise
known by the Receiving Party free of an obligation of
confidentiality prior to disclosure of such information by the
Disclosing Party to the Receiving Party, or (e) to have been
independently developed by employees or agents of the Receiving
Party without the use of Confidential Information of the Disclosing
Party. The terms, conditions and provisions of this Agreement shall
be the Confidential Information of both Parties.
1.13. “ Drug Substance ”
shall mean sumatriptan in all forms including all salts
thereof.
1.14. “ Encumbrances ” shall
mean all encumbrances of any kind, including security interests,
liens, pledges, claims, charges, equitable interests,
hypothecations, mortgages, options, licenses, assignments, powers
of sale, retentions of title, rights of pre-emption, rights of
first refusal, restrictions on transferability, or defects of
title.
1.15. “ Excluded Liabilities
” shall mean all liabilities or obligations of Spectrum that
are not specifically assumed by Par pursuant to this Agreement, and
Excluded Liabilities shall specifically include any and all
liabilities arising out of (i) breach by Spectrum or its
Affiliates of any Assumed Contracts (including the breach by
Spectrum of its obligations under the GSK Settlement Agreement
before and after the Closing Date, whether or not the GSK
Settlement Agreement is assigned to Par in accordance with
Section 2.6), (ii) any financial obligations under the SL
Pharma Agreement as set forth therein on the Closing Date which are
due or become due in the future and/or (iii) the gross
negligence or willful misconduct of Spectrum or its
Affiliates.
1.16. “ FDA ” shall mean the
United States Food and Drug Administration, and any successor
agency thereto.
1.17. “ FDA Letter ” shall
mean the letter attached hereto as Exhibit B duly
executed by an authorized officer of Spectrum notifying the FDA of
the transfer of the Product Regulatory Files to Par.
1.18. “ General Assignment and Bill of
Sale ” shall mean the General Assignment and Bill of Sale
attached hereto as Exhibit A .
1.19. “ Governmental Authority
” or “ Governmental Authorities ” shall
mean any national, foreign, federal, state or local judicial,
legislative, executive, administrative or regulatory body or
authority, or its equivalent, including the FDA.
1.20. “ GSK Agreements ”
shall have the meaning set forth in the Recitals.
3
1.21. “ GSK Settlement Agreement
” shall mean the Agreement between Glaxo Group Limited and
Spectrum, dated November 10, 2006, including as may be amended
from time to time.
1.22. “ GSK Supply Agreement
” shall mean the Supply and Distribution Agreement between
Glaxo Group Limited and Glaxo Wellcome Manufacturing PTE Limited on
the one hand and Par on the other, dated November 10, 2006,
including as may be amended from time to time.
1.23. “ Indemnifying Party ”
shall have the meaning set forth in Section 6.2(a)
.
1.24. “ Intellectual Property
” means all (a) Patents, (b) copyrightable works,
copyrights in works of authorship of any type, including computer
software and industrial designs, registrations and applications for
registration thereof, (c) trade secrets, Know-How and other
material confidential or proprietary technical, business and other
information necessary to Manufacture, test, use or sell the
Product, and all rights in any jurisdiction to limit the use or
disclosure thereof, (d) any and all rights of application
regarding any of the foregoing including with respect to extensions
and the like, and (e) rights to sue and recover damages or
obtain injunctive relief for past and future infringement,
dilution, misappropriation, violation or breach thereof.
1.25. “ Inventory ” shall
mean the quantities and dosage forms of the Products listed on
Schedule 1.25 .
1.26. “ Know-How ” shall mean
any and all product specifications (including the Specifications),
processes, product designs, manufacturing information, engineering
and other manuals and drawings, standard operating procedures, flow
diagrams, chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical, safety, quality assurance, quality control
and clinical data, technical information, data, research records,
supplier lists and similar data and information.
1.27. “ Losses ” shall mean
any liability, loss, judgment, assessment paid or payable to a
third party in connection with a Claim and reasonable related costs
and expenses, including reasonable attorneys’ fees and costs
of defending against lawsuits, complaints, actions or other
litigation; provided , however , that payments in
settlement of a Claim shall only be included to the extent approval
of the settlement was provided in accordance with Section 6 of
this Agreement.
1.28. “
Manufacture/Manufacturing/Manufactured ” shall mean
all operations in the acquisition of materials for, and the
production, packaging, labeling and quality control and release
testing or other analysis of Product and the associate ingredients
and components.
1.29. “ Original Agreement ”
shall mean the Development and Marketing Agreement dated
February 22, 2006 (as amended on November 10, 2006, the
“ Original Agreement ”) between Par and Spectrum
related to products containing sumatriptan as the active
ingredient.
1.30. “ Party ” or “
Parties ” shall have the meaning set forth in the
Preamble.
4
1.31. “ Patents ” means all
patents, patent applications including provisional applications and
statutory invention registrations, including reissues, divisions,
continuations, continuations-in-part, and reexaminations, all
inventions disclosed therein, all rights therein provided by
international treaties and conventions, together with all
applicable foreign counterpart patents and patent applications, and
all rights to obtain patents and registrations thereto, as well as
any extensions, supplementary protection certificates or the like
applicable to any and all of the foregoing.
1.32. “ Person ” shall mean
an individual, a corporation, a limited liability company, a
partnership, an association, a trust or other entity or
organization, including a government or political subdivision or an
agency or instrumentality thereof.
1.33. “ Product ” shall mean
individually and collectively, the dosage forms, strengths and
package forms containing the Drug Substance owned or controlled by
Spectrum and/or its Affiliates as of the Closing Date, including as
set forth on Schedule 1.33 .
1.34. “ Product Intellectual
Property ” shall mean all Intellectual Property owned or
controlled by Spectrum and/or its Affiliates as of the Closing Date
that relates to the Products or Drug Substance and the Manufacture,
testing, use or sale thereof, including as set forth on
Schedule 1.34 .
1.35. “ Product Regulatory Files
” means all Regulatory Files, as applicable, owned or
controlled by Spectrum and/or its Affiliates as of the Closing Date
related to Products or Drug Substance and the Manufacture, testing,
use or sale thereof, including as set forth on Schedule 1.35
.
1.36. “ Purchase Price ”
shall have the meaning set forth in Section 2.1(b)
.
1.37. “ Purchased Assets ”
shall have the meaning set forth in Section 2.1(a)
.
1.38. “ Regulatory Files ”
shall mean:
(a) means the technical, medical and
scientific licenses, permits, waivers, exemptions, registrations,
authorizations and approvals (including applications therefore,
supplements and amendments, pre- and post- approvals, pricing and
third party reimbursement approvals, and labeling approvals) of any
Governmental Authority necessary for the development (including the
conduct of clinical trials), manufacture, distribution, marketing,
promotion, offer for sale, use, import, export or sale of a drug
product or a drug substance.
(b) all technical, scientific, chemical,
biological, pharmacological, and toxicological data as well as all
clinical and preclinical reports (together with clinical data sets
associated with such reports), and all validation documents and
data.
(c) all correspondence to or from
Governmental Authorities.
5
1.39. “ SL Pharma Agreement ”
shall mean the Master Services Agreement between Spectrum and SL
Pharma Labs, Inc. dated July 31, 2007 as it relates to the
Products or Drug Substance and the associated Project Proposals
numbered P-06-031,
P-07-010 and P-05-SP-01, and Purchase Orders numbered 10868, 9758
and 9758-A.
1.40. “ Spectrum’s
Deliverables ” shall have the meaning set forth in
Section 2.4 .
1.41. “ Specifications ”
shall mean, collectively, as applicable, (i) all material
applicable formulae, production and packaging specifications with
respect to the Products and (ii) all material applicable quality
control specifications with respect to the Products.
1.42. “ Transaction Agreements
” shall mean this Agreement and the General Assignment and
Bill of Sale, and each individually a “ Transaction
Agreement .”
1.43. “ United States/U.S. ”
shall mean the United States of America, its territories,
possessions, protectorates and the Commonwealth of Puerto Rico and
any installation, territory, location or jurisdiction under the
purview of the FDA or control of the United States
government.
ARTICLE 2
PURCHASE AND SALE; ALLOCATION
(a) On the Closing Date, and subject to
payment of the Purchase Price by Par, Spectrum will, and will cause
its Affiliates to, sell, assign, convey, license, transfer and
deliver to Par, and Par will purchase and accept from Spectrum and
its Affiliates, sole and exclusive (even as to Spectrum and its
Affiliates) right, title and interest in and to all of the
following assets (collectively, the “Purchased Assets”)
free and clear of all Encumbrances:
(i) all Product Intellectual
Property;
(ii) all Product Regulatory
Files;
(iii) the Assumed Contracts,
provided , however , that, with respect to any such
contract or agreement which relates to the Purchased Assets and one
or more other products of Spectrum or their Affiliates, such
contract or agreement shall only be assigned to, and assumed by,
Par or its designees in part and solely to the extent it relates to
the Products; and
For purposes of
clarity, the Purchased Assets shall not include such confidential
and proprietary manufacturing information for the Drug Substance
provided to the FDA by the manufacturer of the Drug Substance that
is owned and controlled by the third party Drug Substance
supplier.
(b) On the Closing Date, and subject to the
terms and conditions set forth herein, in consideration of the
sale, assignment, conveyance, transfer and delivery of the
Purchased Assets, Par shall make a non-refundable, non-creditable
payment to Spectrum, in the manner described in Section 2.3,
an aggregate purchase price of Twenty Million Dollars ($20,000,000)
(the “ Purchase Price ”).
6
2.2. Assumption of Assumed Liabilities .
With respect to the purchase and sale of the Purchased Assets, in
addition to payment of the Purchase Price, Par shall assume the
Assumed Liabilities on the Closing Date, and subsequently, in due
course in accordance with the terms applicable thereto, pay, honor
and discharge the Assumed Liabilities including the financial and
related obligations to GSK under the GSK Settlement Agreement. Par
assumes no Excluded Liabilities, and the Parties hereto agree that
all such Excluded Liabilities shall remain the sole responsibility
of Spectrum.
2.3. Deliveries by Par . On the Closing
Date, Par shall deliver, or cause to be delivered, to Spectrum cash
in the aggregate amount of the Purchase Price, payable by wire
transfer in immediately available funds to Spectrum’s U.S.
bank account in U.S. dollars in accordance with the following
instructions:
2.4. Deliveries by Spectrum . On or
before the Closing Date, Spectrum shall deliver to Par the
following (collectively, the “Spectrum
Deliverables”):
(a) copies of the Product Regulatory
Files;
(b) copies of the Assumed
Contracts;
(c) the FDA Letter (which will be mailed to
the FDA as well);
(d) a duly executed General Assignment and
Bill of Sale; and
(e) all Inventory; provided that such
inventory that is not delivered on or before the Closing Date shall
be delivered to Par as soon as reasonably practicable.
2.5. GSK Supply Agreement . Spectrum
hereby forever disclaims, disowns, resigns and surrenders any
rights and interest it has in and under the GSK Supply
Agreement.
2.6. GSK Settlement Agreement . The
Parties shall use commercially reasonable efforts to obtain
GSK’s consent for Spectrum to assign the GSK Settlement
Agreement to Par (the “Consent”). Upon the receipt of
the Consent the GSK Settlement Agreement shall be deemed an Assumed
Contract. Until receipt of the Consent or if GSK does not grant the
Consent, the GSK Settlement Agreement shall not be considered an
Assumed Contract and shall not be assigned to Par under this
Agreement. The Parties hereby agree and acknowledge that Par is the
current and only Spectrum Assignee as set forth in
Section 9(b)(iii) of the GSK Settlement Agreement and Spectrum
hereby covenants not to take any action which would remove or
forfeit such designation with respect to Par (or to confer such
designation on another party) and Par hereby agrees as a Spectrum
Assignee (under the terms of the GSK Settlement Agreement) to be
bound by the terms of the GSK Settlement Agreement. In addition to
the Parties’ other obligations with the respect to the GSK
Settlement Agreement set forth herein, Spectrum agrees to
(a) not breach the GSK Settlement Agreement, (b) promptly
provide Par with notice and a copy of any communication with GSK
regarding the GSK Settlement Agreement and (c) promptly
cooperate with Par to the extent necessary to meet all of
Spectrum’s and Par’s (as a Spectrum Assignee under the
GSK Settlement Agreement) obligations under the GSK Settlement
Agreement and afford Par the benefit of any of Spectrum’s
rights under the GSK Settlement Agreement, at Par’s
reasonable request and direction. Par hereby agrees to (as between
Par and Spectrum) be responsible for and indemnify Spectrum for any
obligations of Spectrum under Section 9(d) or 9(e) of the GSK
Settlement Agreement and any actions or inactions of Par as a
Spectrum Assignee under the GSK Settlement Agreement.
7
2.7. Original Agreement . The Parties
hereby mutually agree that the Original Agreement is terminated in
its entirety, and further each Party hereby forever disclaims,
disowns, resigns and surrenders any rights and interest it has in
and under the Original Agreement including any and all rights or
interests it may have or otherwise had following any expiration or
termination of the Original Agreement.
2.8. Non-Compete . Spectrum hereby
covenants and agrees that neither it nor its Affiliates shall,
directly, or indirectly, in the United States, for a period of five
(5) years from the Execution Date, make, have made, use,
develop, import/export, register, file, promote, market,
Manufacture, distribute, offer to sell, sell or otherwise
commercialize any of the Products or any pharmaceutical product
containing the Drug Substance or assist any third party in the
forgoing.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF SPECTRUM
Spectrum, on behalf of itself and its
Affiliates, hereby represents and warrants to Par that as of the
Execution Date and as of the Closing Date:
3.1. Organization, Good Standing, Power,
etc . Spectrum is duly organized, validly existing and in good
standing under the laws of the State of Delaware. Spectrum has the
requisite organizational power and authority to execute and deliver
this Agreement, the other Transaction Agreements and
Spectrum’s Deliverables, and to consummate the transactions
contemplated hereby and thereby, as applicable. The execution and
delivery of this Agreement by Spectrum, the execution and delivery
by Spectrum of the other Transaction Agreements and
Spectrum’s Deliverables, as applicable, and the consummation
by Spectrum of the transactions contemplated hereby and thereby, as
applicable, have been duly authorized by all necessary
organizational action on the part of Spectrum and no other or
further organizational actions will be necessary for the execution
and delivery of such agreements, as applicable, by Spectrum, the
performance by Spectrum of its obligations hereunder and
thereunder, as applicable, and the consummation by Spectrum of the
transactions contemplated hereby or thereby, as applicable. Each
Transaction Agreement, at the time such agreement is delivered,
will have been duly executed and delivered by Spectrum and
constitutes legal, valid and binding obligations of Spectrum,
enforceable against Spectrum in accordance with its
terms.
3.2. No Conflict . The execution,
delivery and performance by Spectrum of this Agreement, the other
Transaction Agreements and Spectrum’s Deliverables, and the
consummation by Spectrum of the transactions contemplated hereby
and thereby will not require any material notice to, material
filing with, or the material consent (except for the Consent in the
event the GSK Settlement Agreement is assigned to Par in accordance
with Section 2.6), approval or authorization of, any Person or
Governmental Authority, except for the transfer of the Product
Regulatory Files,
|