1
*** Certain information (indicated by an asterisk) has been omitted from this
document pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.
EXHIBIT 2.1
MIDRIN ASSET AND INVENTORY PURCHASE AGREEMENT
This Midrin Asset and Inventory Purchase Agreement (this "Agreement") is
made and entered into as of June 29, 2001, by and among WOMEN FIRST HEALTHCARE,
INC., a Delaware corporation ("Buyer"), and ELAN PHARMA INTERNATIONAL LIMITED,
an Irish Corporation ("EPIL"), and ELAN PHARMACEUTICALS, INC., a Delaware
corporation ("EP"), hereinafter sometimes collectively referred to as "Seller".
RECITALS
WHEREAS, subject to the terms and conditions of this Agreement, Seller
desires to sell to Buyer, and Buyer desires to purchase from Seller, the
Purchased Assets (as defined below).
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual
covenants and promises contained herein, and for other good and valuable
consideration, the receipt and sufficiency of which hereby are acknowledged, the
Parties agree as follows:
ARTICLE I
DEFINITIONS
SECTION 1.01 DEFINED TERMS.
As used in this Agreement, the following defined terms have the meanings
described below:
(a) "Action or Proceeding" means any action, suit, proceeding,
arbitration, Order, inquiry, hearing, assessment with respect to fines
or penalties or litigation (whether civil, criminal, administrative,
investigative or informal) commenced, brought, conducted or heard by or
before, or otherwise involving, any Governmental or Regulatory
Authority.
(b) "Activity Date" has the meaning set forth in Section
8.10(d).
(c) "Adverse Effect" means an effect or condition that is, or
reasonably could be expected to be, or could reasonably be expected to with the
passage of time to be, materially adverse to, or materially change the condition
of, the Purchased Assets, the business, results of operations, or financial
condition of the Business, or the Product.
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(d) "Affiliate" means, with respect to any Person, any other
Person which controls, is controlled by or is under common control with such
person or entity. A person or entity shall be regarded as in control of another
entity if it owns or controls, directly or indirectly, (i) in the case of
corporate entities at least fifty percent (50%) (or the maximum ownership
interest permitted by law) of the equity securities in the subject entity
entitled to vote in the election of directors and, (ii) in the case of an entity
that is not a corporation, at least fifty percent (50%) (or the maximum
ownership interest permitted by law) of the equity securities or other ownership
interests with the power to direct the management and policies of such subject
entity or entitled to elect the corresponding management authority, provided,
however, that the term "Affiliate" shall not include subsidiaries or other
entities in which a Party or its Affiliates owns a majority of the ordinary
voting power necessary to elect a majority of the board of directors or other
governing board, but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in effect.
(e) "Agreement" has the meaning set forth in the Preamble to
this Agreement.
(f) "Annual Period" means each one year period beginning on July
1 and ending on June 30; the first such Annual Period commencing on July 1, 2001
and the last such Annual Period beginning on July 1, 2010.
(g) "Assets and Properties" of any Person means all assets and
properties of any kind, nature, character and description (whether real,
personal or mixed, whether tangible or intangible, whether absolute, accrued,
contingent, fixed or otherwise and wherever situated), including the goodwill
related thereto, operated, owned or leased by such Person, including cash, cash
equivalents, accounts and notes receivable, chattel paper, documents,
instruments, general intangibles, regulatory approvals, equipment, inventory,
goods and intellectual property.
(h) "Assumed Contract" means any Contract or portion of a
Contract to which Seller or any of its Affiliates is a party to the extent that
such Contract relates to the manufacture, marketing, sale or, distribution of
the Product, including those Contracts listed on Section 6.05 of the Seller
Disclosure Schedule, but excluding any Multi-Product Contracts.
(i) "Assumed Liabilities" means (i) all accounts payable
incurred by Buyer or an Affiliate of Buyer with respect to the Business
subsequent to the Closing, (ii) all Liabilities and obligations that Buyer
has-expressly assumed or agreed to assume under this Agreement, (iii) all
Liabilities and obligations under or pursuant to the Assumed Contracts to be
performed following the Closing, but only to the extent that the obligations to
pay or perform under such Liabilities, obligations or Assumed Contracts arise
following the Closing and relate to goods or services or other benefit received
by Buyer after the Closing, (iv) except as otherwise provided herein, all state
and federal Medicaid/Medicare rebates related to Product sold after Closing, (v)
except as otherwise provided herein, all credits, chargeback rebates,
utiliza-
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tion based rebates, reimbursements and similar payments to wholesalers and other
distributors, buying groups, insurers and other institutions related to Product
that is sold after Closing, (vi) all Liabilities and obligations relating to
product liability claims or threatened claims or injuries caused by Product sold
by Buyer after the Closing, and (vii) except as otherwise provided herein, all
other Liabilities and obligations that arise out of or are related to the
ownership of the Purchased Assets (including the Regulatory Approvals) or the
Product Inventory, or operation of the Business from and after the Closing.
(j) "Books and Records" means all files, documents, instruments,
papers, books and records (scientific or financial), excluding Marketing
Materials, owned by Seller or an Affiliate of Seller to the extent that the
foregoing relate to the Business, including any pricing lists, training
materials, customer lists, vendor lists, archived documents, including raw data
and raw data files used to support clinical and regulatory reports, financial
data and all documentation relating to the Intellectual Property or the
Registered Intellectual Property, but excluding any such items to the extent
that (i) any applicable Law prohibits their transfer or (ii) any transfer
thereof would subject Seller or any of its Affiliates to any contractual or
other Liability or obligation.
(k) "Business" means the activities of manufacturing, marketing,
selling and distributing the Product in the Territory.
(l) "Business Day" means a day other than Saturday, Sunday or
any day on which banks located in New York are authorized or obligated to close.
(m) "Buyer" has the meaning set forth in the Preamble to this
Agreement.
(n) "Buyer Disclosure Schedule" has the meaning set forth in
Article VII hereof.
(o) "Buyer Governmental Consent" has the meaning set forth in
Section 7.03(a).
(p) "Buyer Indemnified Parties" has the meaning set forth in
Section 11.02(a).
(q) "Buyer Labeling" means the printed labels, labeling and
packaging materials, including printed carton, container label and package
inserts, used by Buyer and bearing Buyer's name for the Product.
(r) "Buyer Third Party Consent" has the meaning set forth in
Section 7.03(b).
(s) "cGMP" means current good manufacturing practices of the
FDA, as set forth in 21 C.F.R. Parts 210 and 211 and all applicable rules,
regulations, guides and guidance, as amended from time to time and in effect
during the term of this Agreement.
(t) "Closing" has the meaning set forth in Section 5.01.
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(u) "Closing Date" means the date that the Closing actually
occurs as provided in Section 5.01.
(v) "Closing Payment" has the meaning set forth in Section
4.01(a)(i).
(w) "Confidential Information" has the meaning set forth in
Section 12.01.
(x) "Contract" means any and all commitments, contracts,
purchase orders, leases, or other agreements, whether written or oral.
(y) "Corporate Names" has the meaning set forth in Section
8.06(a).
(z) "Damages" has the meaning set forth in Section 11.02(a).
(aa) "Disclosing Party" has the meaning set forth in Section
12.01.
(bb) "Dollars" and the sign "$" each means lawful money of the
United States.
(cc) "Encumbrance" means any mortgage, pledge, assessment,
security interest, deed of trust, lease, lien, adverse claim, levy, charge or
other encumbrance of any kind, or any conditional sale or title retention
agreement, whether voluntarily incurred or arising by operation of law, or other
agreement to give any of the foregoing in the future.
(dd) "Excluded Assets" means all Assets and Properties of Seller
and its Affiliates except the Purchased Assets.
(ee) "Excluded Liabilities" means all Liabilities of Seller and
its Affiliates except the Assumed Liabilities.
(ff) "Expiration Date" means the date two (2) years after the
Closing Date.
(gg) "Government or Regulatory Authority" means any court,
tribunal, arbitrator, authority, agency, commission, official or other
instrumentality of the United States or other country, or any supra-national
organization, state, county, city or other political subdivision thereof.
(hh) "Indemnification Claim Notice" has the meaning set forth in
Section 11.02(c).
(ii) "Indemnified Party" has the meaning set forth in Section
11.02(c).
(jj) "Indemnifying Party" has the meaning set forth in Section
11.02(c).
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(kk) "Indemnitee" and "Indemnitees" have the respective meanings
set forth in Section 11.02(c).
(ll) "Intellectual Property" means any and all of the following
intellectual property rights owned by or licensed to Seller and its Affiliates
to the extent used by Seller in conducting the Business: (i) Patents, (ii)
Know-how; (iii) copyrights, copyright registrations and applications therefor,
and all other rights corresponding thereto; (iv) internet domain names; (v)
brand names, trade names, trade dress, logos, common law trademarks and service
marks, and trademark and service xxxx registrations, renewals and applications
therefor, including all good will of the Business symbolized thereby or
associated therewith (excluding the Elan tradename and Elan trademark and logo);
(vi) any similar or equivalent rights to any of the foregoing in the Territory;
and (vii) rights to xxx and recover damages or obtain injunctive relief for
infringement, dilution or misappropriation of the items set forth in clauses (i)
- (vi) above.
(mm) "Know-how" means all information and materials owned or
licensed by Seller and its Affiliates to the extent used by Seller in conducting
the Business, including any Product specifications, technical knowledge,
expertise, skill, practice, inventions, procedures, formulae, trade secrets,
confidential information, analytical methodology, processes, pre-clinical,
clinical, stability, toxicology and other data, market studies and all other
experience and know-how, in tangible or intangible form, whether or not patented
or patentable; provided, however, that Know-how shall not include (i) any plant,
property, equipment or employees, and (ii) any items to the extent that any
applicable Law prohibits their transfer or any transfer thereof would subject
Seller or any of its Affiliates to any material Liability or other obligation.
(nn) "Knowledge" with respect to any Party, means the actual
knowledge of the senior management (or persons performing similar functions) of
such Person.
(oo) "Law" means any federal, state or local law, statute or
ordinance, or any rule, regulation, or published Guidelines promulgated by any
Governmental or Regulatory Authority.
(pp) "Liability" or "Liabilities" means any liability or
liabilities, as the case may be, (whether known or unknown, asserted or
unasserted, absolute or contingent, accrued or unaccrued, liquidated or
unliquidated, and due or to become due), including any liability or liabilities
for Taxes.
(qq) "Marketing Materials" means all market research, marketing
plans, media plans, advertising, promotional materials, reprints, consumer and
physician education materials, and marketing books and records owned by Seller
and its Affiliates as of Closing, to the extent the foregoing are used in
connection with the marketing or promotion of the Product,
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other than any such items to the extent that (i) any applicable Law prohibits
their transfer or (ii) any transfer thereof would subject Seller or any of its
Affiliates to any contractual or other Liability or obligation.
(rr) "Maximum Returns Credit Amount" has the meaning set forth
in Section 8.10(a).
(ss) "Multi-Product Contracts" has the meaning set forth in
Section 8.12.
(tt) "Net Sales" means the gross amount invoiced for the Product
for an applicable period by Buyer or its Affiliates to third parties less:
(i) quantity, trade and/or cash discounts allowed or
given;
(ii) credits or refunds allowed for the return of
rejected, outdated, damaged or returned Product;
(iii) rebates, chargebacks and price adjustments allowed
or given; and
(iv) sales and other excise taxes and duties directly
related to the sale, transportation or delivery, to the extent that such
items are included in the gross invoice price (but not including taxes
assessed against the income derived from such sale).
Each of the items set forth in clauses (i)-(iv) above shall be deducted
from the gross amount invoiced only to the extent charged against Buyer or its
Affiliates and evidenced in Buyer's or its Affiliates' books and records of
account. Deductions shall be determined in accordance with U.S. Generally
Accepted Accounting Principles consistently applied. If a Product is sold for
compensation other than cash, Net Sales shall be calculated based on the gross
list price of the Product on the date of sale.
Sales of Product by and between a Party and its Affiliates are not sales
to a third party and shall be excluded from Net Sales calculations for all
purposes.
(uu) "Non-Disclosing Party" has the meaning set forth in Section
12.01.
(vv) "Non-Soliciting Party" has the meaning set forth in Section
8.05.
(ww) "Order" means any writ, judgment, decree, injunction or
similar order of any Governmental or Regulatory Authority (in each such case
whether preliminary or final).
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(xx) "Ordinary Course of Business" means such action that is
consistent with the past practices of the Business.
(yy) "Parties" means Buyer and Seller.
(zz) "Party" means each of Buyer and Seller.
(aaa) "Patent" means any patents, provisional patent
applications and similar instruments (including any divisions, continuations,
continuations-in-part, reissues, renewals, extensions or the like of any such
patent, application or instrument) as well as any foreign equivalents thereof
(including certificates of invention and any applications therefor).
(bbb) "Permitted Encumbrance" means (i) any Encumbrance for
Taxes not yet due or delinquent or for those Taxes being contested in good faith
by appropriate proceedings for which adequate reserves have been established and
(ii) any minor imperfection of title or similar Encumbrance that would not have
an Adverse Effect.
(ccc) "Person" means any natural person, corporation, general
partnership, limited partnership, limited liability company, proprietorship,
other business organization, trust, union, association or Governmental or
Regulatory Authority.
(ddd) "Product" means all formulations of the pharmaceutical
product as sold by or on behalf of Seller under the registered trademark
"Midrin(R)."
(eee) "Product Inventory" means all inventory owned as of the
Closing by EP of finished Product or works in progress or materials used in the
manufacture of finished Product, whether held at a location or facility of EP
(or of any other Person on behalf of EP or any Affiliate) or in transit to or
from EP or any Affiliate (or any such other Person).
(fff) "Purchased Assets" means, subject to Section 2.02 and
except as otherwise provided on the Seller Disclosure Schedule, all assets and
properties of any kind, nature, character and description to the extent used by
Seller in conducting the Business (whether real, personal or mixed, whether
tangible or intangible, whether absolute, accrued, contingent, fixed or
otherwise and wherever situated), including the goodwill related thereto,
operated, or owned by such Seller, including the following: (i) the Product
Inventory; (ii) the Intellectual Property; (iii) the Registered Intellectual
Property; (iv) the Assumed Contracts; (v) the Books and Records; (vi) the
Regulatory Approvals; and (vii) the Marketing Materials
(ggg) "Registered Intellectual Property" means, to the extent
they relate to the Product, all of the following Intellectual Property
registered in the Territory: (i) the Patents identified in Section 6.07(a) of
the Seller Disclosure Schedule; (ii) the registered trademarks and applications
to register trademarks identified in Section 6.07(a) of the Seller Disclosure
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Schedule; and (iii) the Internet domain names registered with registrars
accredited by the Internet Corporation for Assigned Names and Numbers identified
in Section 6.07(a) of the Seller Disclosure Schedule.
(hhh) "Regulatory Approvals" means, to the extent they relate to
the Product and to the extent owned or licensed by Seller, the new drug
applications and new drug submissions for the Product identified in Section
6.10(a) of the Seller Disclosure Schedule, all supplements thereto and all
regulatory files relating thereto, and any and all (i) regulatory filings and
supporting documents, clinical studies and tests (excluding DEA licenses, and
wholesale, distributor and pharmacy licenses) relating to the Product; and (ii)
records maintained under cGMPs or other record keeping or reporting requirements
of the FDA, the Environmental Protection Agency, the Occupational Health and
Safety Administration or any other Governmental or Regulatory Authorities,
including all investigational new drug applications, abbreviated new drug
applications, drug master files, FDA approvals for export, FDA warning letters,
FDA Notices of Adverse Finding Letters, FDA audit reports (including any
responses to such reports), all other correspondence and communications with
Governmental or Regulatory Authorities in connection with the Product, adverse
event files, documents related to drug efficacy study implementation, and IND
safety reports and complaint files (as well as any foreign equivalents of the
foregoing) with respect to the Product.
(iii) "Royalty Payment" has the meaning set forth in Section
4.01(b).
(jjj) "Seller" has the meaning set forth in the Preamble to this
Agreement.
(kkk) "Seller Disclosure Schedule" has the meaning set forth in
the preamble to Article VI of this Agreement.
(lll) "Seller Governmental Consent" has the meaning set forth in
Section 6.03(a).
(mmm) "Seller Third Party Consent" has the meaning set forth in
Section 6.03(b).
(nnn) "Soliciting Party" has the meaning set forth in Section
8.05.
(ooo) "Tax" means all of the following tax in connection with
the operations of the Business or the transactions contemplated hereby: (i) any
net income, alternative or add-on minimum tax, gross income, gross receipts,
sales, use, ad valorem, transfer, franchise, profits, license, excise,
severance, stamp, occupation, premium, property, environmental or windfall
profit tax, custom, duty or other tax, governmental fee or other like assessment
imposed by any governmental, regulatory or administrative entity or agency
responsible for the imposition of any such tax (domestic or foreign); (ii) any
Liability for the payment of any
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amounts of the type described in (i) as a result of being a member of any
affiliated, consolidated, combined, unitary or other group for any Taxable
period; and (iii) any Liability for the payment of any amounts of the type
described in (i) or (ii) as a result of any express or Implied obligation to
indemnify any other person.
(ppp) "Territory" means the United States of America and its
possessions and territories.
(qqq) "Third Party Claim" has the meaning set forth in Section
11.02(d).
(rrr) "Transition Chargebacks" has the meaning set forth in
Section 8.10(d).
(sss) "Transition Services " has the meaning set forth in
Section 4.03.
SECTION 1.02 CONSTRUCTION OF CERTAIN TERMS AND PHRASES.
Unless the context of this Agreement otherwise requires: (a) words of
any gender include each other gender; (b) words using the singular or plural
number also include the plural or singular number, respectively; (c) the terms
"hereof," "herein," "hereby" and derivative or similar words refer to this
entire Agreement; (d) the terms "Article," "Section" or "Exhibit" refer to the
specified Article, Section or Exhibit of this Agreement; (e) the term "or" has,
except where otherwise indicated, the inclusive meaning represented by the
phrase, "and/or"; and (f) the term "including" means "Including without
limitation." Whenever this Agreement refers to a number of days, such number
shall refer to calendar days unless Business Days are specified. All accounting
terms used but not defined herein shall have the meaning ascribed to such terms
under U.S. Generally Accepted Accounting Principles, consistently applied.
ARTICLE II
PURCHASE AND SALE OF ASSETS AND PRODUCT INVENTORY
SECTION 2.01 PURCHASE AND SALE OF ASSETS AND PRODUCT INVENTORY.
(a) Subject to the terms and conditions of this Agreement, at
the Closing, Seller shall sell, transfer, convey, assign and deliver good and
marketable title to the Purchased Assets used by Seller in conducting the
Business to Buyer, and Buyer shall purchase, acquire and accept from Seller, as
of the Closing, the Purchased Assets relating to the Territory free and clear of
all Encumbrances, except as otherwise specifically provided in this Agreement.
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(b) Notwithstanding anything contained in this Agreement to the
contrary, (i) from and after the Closing, Seller shall retain all of its right,
title and interest in and to the Excluded Assets and (ii) Seller may retain an
archival copy of all Assumed Contracts, Books and Records, Marketing Materials
and other documents or materials conveyed hereunder.
SECTION 2.02 ASSIGNABILITY AND CONSENTS.
Notwithstanding anything to the contrary contained in this Agreement, if
the sale, assignment, transfer, conveyance or delivery or attempted sale,
assignment, transfer, conveyance or delivery to Buyer of any asset that would be
a Purchased Asset is (a) prohibited by any applicable Law or (b) would require
any authorizations, approvals, consents or waivers from a third Person or
Governmental or Regulatory Authority and such authorizations, approvals,
consents or waivers shall not have been obtained prior to the Closing, then in
either case the Closing shall proceed without the sale, assignment, transfer,
conveyance or delivery of such asset and this Agreement shall not constitute an
agreement for the sale, assignment, transfer, conveyance or delivery of such
asset; provided that nothing in this Section 2.02 shall be deemed to waive the
rights of Buyer not to consummate the transactions contemplated by this
Agreement if the conditions to its obligations set forth in Article X have not
been satisfied. In the event that the Closing proceeds without the sale,
assignment, transfer, conveyance or delivery of any such asset, then following
the Closing, the Parties shall use their reasonable best efforts, and cooperate
with each other, to obtain promptly such authorizations, approvals, consents or
waivers; provided, however, that, except as provided for in Section 8.09, Seller
shall not be required to pay any consideration to obtain in any such
authorization, approval, consent or waiver. Pending such authorization,
approval, consent or waiver, the Parties shall cooperate with each other in any
mutually agreeable, reasonable and lawful arrangements designed to provide to
Buyer the benefits of use of such asset and to Seller the benefits, including
any indemnities, that, in each case, it would have obtained had the asset been
conveyed to Buyer at the Closing. To the extent that Buyer is provided the
benefits pursuant to this Section 2.02 of any Contract, Buyer shall (x) perform
for the benefit of the other parties thereto the obligations of Seller
thereunder and (y) shall satisfy any related Liabilities with respect to such
Contract that, but for the lack of an authorization, approval, consent or waiver
to assign such obligations or Liabilities to Buyer, would be Assumed
Liabilities. Once authorization, approval, consent or waiver for the sale,
assignment, transfer, conveyance or delivery of any such asset not sold,
assigned, transferred, conveyed or delivered at the Closing is obtained, Seller
shall assign, transfer, convey and deliver such asset to Buyer at no additional
cost to Buyer.
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ARTICLE III
ASSUMPTION OF LIABILITIES
SECTION 3.01 ASSUMPTION OF ASSUMED LIABILITIES.
(a) Subject to the terms and conditions of this Agreement, as of
the Closing Date, Buyer agrees to assume, satisfy, perform, pay, discharge and
otherwise be responsible for the Assumed Liabilities.
(b) Other than the Assumed Liabilities, Buyer shall not assume
or be deemed to have assumed or guaranteed, or otherwise be responsible for, any
Excluded Liability or any other Liability or obligation of any nature, whether
direct or indirect, of Seller or any of its Affiliates relating to the Purchased
Assets or otherwise, without regard to whether such Liability or obligation is
known, knowable, or unknown, matured or unmatured, liquidated or unliquidated,
fixed or contingent, arising out of acts, omissions or occurrences prior to, the
Closing Date or any conditions existing prior to the Closing Date.
ARTICLE IV
PURCHASE PRICE AND PAYMENT
SECTION 4.01 PURCHASE PRICE.
(a) Closing Consideration. As consideration for the Purchased
Assets (including the Product Inventory), Buyer shall:
(i) pay to Seller Fifteen Million Dollars ($15,000,000)
at Closing (the "Closing Payment") and
(ii) assume the Assumed Liabilities as of the Closing.
The Closing Payment shall be evidenced by cross- receipts ; provided,
however, that Buyer shall finance the Closing Payment subject to and in
accordance with the terms of the Securities Purchase Agreement. The Closing
Payment is non-refundable and not subject to any future performance obligations
upon Seller or its affiliates.
(b) Additional Consideration. In addition to the Closing
Payment, Buyer shall pay to EPIL a royalty equal to *** of Net Sales (each a
"Royalty Payment") for sales made during a period of *** commencing as of ***
and ending as
*** Certain information (indicated by an asterisk) has been omitted from this
document pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.
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of *** (the "Royalty Period"); provided, however, commencing in the year
beginning ***, the Royalty Payment shall only be payable on annual Net Sales of
up to ***. The Royalty Payment shall be paid by Buyer to EPIL on a quarterly
basis, within forty- five (45) days following the end of each calendar quarter
(or if such day is not a Business Day, then the Business Day immediately
thereafter) by wire transfer of immediately available funds to an account or
accounts designated by EPIL prior to the date on which such payment is due.
(c) Determination of Net Sales. As soon as practical, but under
no circumstances more than forty-five (45) days after the last day of each
Annual Period, Buyer shall provide EPIL with a calculation, in reasonable
detail, of the Net Sales for the applicable period.
SECTION 4.02 IMPACT OF FAILURE TO MAKE PAYMENTS.
The failure by Buyer to make any payments due to Seller pursuant to
Section 4.01(b) shall constitute an "Event of Default" under the Note.
SECTION 4.03 TRANSITION SERVICES.
During the sixty (60) day period following Closing, Seller shall continue to
perform on behalf of Buyer, certain critical transition services with respect to
the sale and distribution of the Product ("Transition Services") as may be
mutually agreed to in writing in good faith by the Parties. In consideration of
the Transition Services, Buyer shall pay Seller its actually fully burdened cost
plus ten percent (10%) together with all out-of pocket costs and expenses. For
the avoidance of doubt, no portion of the consideration paid by Buyer for the
Purchased Assets shall be repayable by Seller in the event that such Transition
Services are not performed by Seller.
ARTICLE V
CLOSING
SECTION 5.01 TIME AND PLACE.
The closing of the transactions contemplated by this Agreement,
including the purchase and sale of the Purchased Assets and the assumption of
the Assumed Liabilities (the "Closing"), shall take place simultaneously with
the execution of this Agreement, which shall occur on or before June 29th,
2001 at the offices of Reitler Xxxxx LLC, 000 Xxxxx Xxxxxx, 00xx Xxxxx, Xxx
Xxxx, Xxx Xxxx 00000, unless another time or place shall be agreed to by the
Parties.
*** Certain information (indicated by an asterisk) has been omitted from this
document pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.
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SECTION 5.02 DELIVERIES AT CLOSING
(a) Closing Deliveries by Seller and/or its Affiliates.
At the Closing, Seller shall deliver or cause to be delivered to Buyer:
(i) each of the Patent assignment, trademark assignment
and other intellectual property assignment documents necessary to
transfer the Intellectual Property and the Registered Intellectual
Property to Buyer in form and substance reasonably acceptable to Seller
and Buyer;
(ii) assignment and assumption agreements, in form and
substance reasonably acceptable to Seller and Buyer, assigning to Buyer
all rights and obligations of Seller and its Affiliates in and to the
Assumed Contracts;
(iii) copies of all Seller Governmental Consents and
Seller Third Party Consents; and
(iv) the certificates and other documents to be
delivered pursuant to Article X hereof; and
(v) an opinion of counsel to the effect that the
transactions contemplated by this Agreement have been duly and
validly authorized by the Seller, the Seller has due authority
to sell the Purchased Assets.
(b) Closing Deliveries by Buyer.
At the Closing, Buyer shall deliver or cause to be delivered to Seller
and/or its Affiliates:
(i) the Closing Payment; and
(ii) the certificates and other documents to be
delivered pursuant to Article IX hereof.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represents and warrants to Buyer as of the date hereof, subject
to such exceptions as are specifically disclosed in the disclosure schedule
(referencing the appropriate Xxx-
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tions hereof) supplied by Seller to Buyer and dated as of the date hereof (the
"Seller Disclosure Schedule"), which Seller Disclosure Schedule shall be deemed
to be representations and warranties of Seller as if made herein, as follows:
SECTION 6.01 CORPORATE ORGANIZATION OF SELLER.
EP is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware and has all requisite power and
authority to own its assets and carry on its business as currently conducted by
it. EPIL is a corporation duly organized, validly existing and in good standing
under the laws of the Republic of Ireland and has all requisite power and
authority to own its assets and carry on its business as currently conducted by
it. Each Seller is duly authorized to conduct its business and is in good
standing in each jurisdiction where such qualification is required, except for
any jurisdiction where failure to so qualify could not reasonably be expected,
individually or in the aggregate, to have an Adverse Effect or materially impair
or delay Seller's ability to perform its obligations hereunder.
SECTION 6.02 AUTHORITY OF SELLER.
Each Seller has all necessary power and authority and has taken all
actions necessary to enter into this Agreement and to carry out the transactions
contemplated hereby. The Board of Directors or Executive Committee of the Board
of Directors of each Seller has taken all action required by Law, its
Certificate of Incorporation, Bylaws or other organizational documents and
agreements, to be taken by it to authorize the execution and delivery of this
Agreement by the Seller and the consummation of the transactions (including the
performance by the Seller of its obligations) contemplated hereunder. This
Agreement has been duly and validly executed and delivered by each Seller and,
when executed and delivered by Buyer, will constitute a legal, valid and binding
obligation of each Seller enforceable against it in accordance with its terms
except (a) as limited by applicable bankruptcy, insolvency, reorganization,
moratorium and other laws of general application affecting enforcement of
creditors rights generally, and (b) as limited by laws relating to the
availability of specific performance, injunctive relief or other equitable
remedies.
SECTION 6.03 CONSENTS AND APPROVALS.
(a) All consents, waivers, approvals, Orders, authorizations of,
declarations or filings with any Governmental or Regulatory Authority (each a
"Seller Governmental Consent") that are required by or with respect to Seller or
its Affiliates in connection with the execution and delivery if this Agreement
by the Seller, and its performance of its obligations hereunder are set forth on
Section 6.03(a) of the Seller Disclosure Schedule. Each Seller Governmental
Consent has been obtained, except to the extent that the failure to obtain such
Seller Governmental Consent would not have an Adverse Effect.
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(b) All consents, waivers, approvals, authorizations of, or
notices to, any third party (other than a Governmental or Regulatory Authority)
(each a "Seller Third Party-Consent") that are required by or with respect to
Seller or its Affiliates in connection with the execution and delivery of this
Agreement by the Seller, and its performance of its obligations hereunder are
set forth on Section 6.03(b) of the Seller Disclosure Schedule. Each Seller
Third Party Consent has been obtained, except to the extent that the failure to
obtain such Seller Third Party Consent would not have an Adverse Effect.
SECTION 6.04 NON-CONTRAVENTION.
The execution and delivery by each Seller of this Agreement does not,
and the performance by it of its obligations under this Agreement and the
consummation of the transactions contemplated hereby will not:
(a) conflict with or result in a violation or breach of any of
the terms, conditions or provisions of the Certificate of Incorporation, Bylaws
or other applicable organizational documents of each Seller;
(b) conflict with or result in a violation or breach of any term
or provision of any Law applicable to each Seller, the Business or the Purchased
Assets, other than such conflicts, violations or breaches as would not have an
Adverse Effect; or
(c) conflict with or result in a breach or default (or an event
which, with notice or lapse of time or both, would constitute a breach or
default) under, or result in the termination or cancellation of, or accelerate
the performance required by, or result in the creation or imposition of any
security interest, lien or any other Encumbrance (other than a Permitted
Encumbrance) upon any Assumed Contract, other than such conflicts, breaches or
defaults as would not have an Adverse Effect.
SECTION 6.05 ASSUMED CONTRACTS.
Section 6.05 of the Seller Disclosure Schedule sets forth a complete and
correct list of each Assumed Contract where the payment obligations after the
Closing exceed Twenty-Five Thousand Dollars ($25,000.00). Each of the Assumed
Contracts is in effect and constitutes a legal, valid and binding agreement,
enforceable in accordance with its terms, of Seller or an Affiliate of Seller;
and Seller has performed all of its required material obligations under, and is
not in material violation or breach of or default under, any such Assumed
Contract. To the Knowledge of Seller, the other parties to the Assumed Contracts
are not in material violation or breach of or default under, and have not given
any notice of any claim of default under, any such Assumed Contract. Seller has
made available to Buyer complete and correct copies of all Assumed Contracts
identified in Section 6.05 of the Seller Disclosure Schedule.
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SECTION 6.06 PURCHASED ASSETS GENERALLY.
Seller has good and marketable title to the Books and Records, Equipment
and Marketing Materials, free and clear of all Encumbrances (other than
Permitted Encumbrances). The Purchased Assets and the Product Inventory include
all material assets and properties that are owned, licensed or controlled by
Seller with respect to the Product and that are reasonably required for Buyer to
operate the Business after the Closing in substantially the manner and
substantially to the extent operated by Seller prior to the Closing; provided,
however, that Buyer acknowledges and agrees that (a) the Purchased Assets
exclude any items to the extent that (i) any applicable Law prohibits their
transfer or (ii) any transfer thereof would subject Seller or any of its
Affiliates to any contractual or other Liability or obligation and (b) certain
items have been expressly excluded from the definition of Purchased Assets and
the components thereof.
SECTION 6.07 INTELLECTUAL PROPERTY RIGHTS.
Section 6.07 of the Seller Disclosure Schedule sets forth a complete and
correct list of all Intellectual Property that is registered in the Territory,
is owned or licensed by Seller and used by Seller in connection with the
Product. Seller or its Affiliates own all right, title and interest in and to,
or have a license, sublicense or other permission to use, all of the Registered
Intellectual Property, free and clear of all Encumbrances except Permitted
Encumbrances. All necessary registration, maintenance and renewal fees in
connection with such Registered Intellectual Property have been paid and all
necessary documents and certificates in connection with such Registered
Intellectual Property have been filed with the relevant copyright, trademark or
patent Governmental or Regulatory Authorities and are currently in force.
SECTION 6.08 LITIGATION.
Except as set forth on Section 6.08 of the Seller Disclosure Schedule,
which Seller will continue to be solely responsible for and indemnify Buyer
against, (i) there are no actions, suits, proceedings, investigations,
arbitration proceedings or other proceedings pending or, to the knowledge of
Seller, threatened against or affecting the Product or the Purchased Assets by
or before any Governmental or Regulatory Authority, or by or before any
arbitrator, and (ii) there is not currently outstanding against Seller any
judgment, decree, injunction, rule, order or award of any Governmental or
Regulatory Authority or arbitrator relating to the Product or the Purchased
Assets.
SECTION 6.09 FINANCIAL INFORMATION.
Seller has provided all material financial information related to the
Purchased Assets requested by Buyer to the extent reasonably available to
Seller. Such financial information
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was derived from the books and records of Seller and was prepared by Seller in
accordance with generally accepted accounting principles consistently applied
and fairly and accurately presents, in all material respects, the sales and
contributions of and other information with respect to the Product for the
periods shown. No representation or warranty whatsoever is made with respect to
any financial projections provided by Seller.
SECTION 6.10 REGULATORY APPROVALS; COMPLIANCE WITH LAW.
(a) Section 6.10(a) of the Seller Disclosure Schedule sets forth
the new drug applications and new drug submissions for the Product. Seller has
obtained all of the necessary Regulatory Approvals relating to the manufacture
and sale of the Product in the Territory as currently conducted and has not
failed to obtain any such Regulatory Approval which could reasonably be expected
to have an Adverse Effect. Seller has made available to Buyer complete and
correct copies of all Regulatory Approvals.
(b) Except as set forth on Section 6.10(b) of the Seller
Disclosure Schedule or which could reasonably be expected to have an Adverse
Effect, Seller has conducted and is currently conducting the manufacturing,
promotion, advertising, marketing and sale of the Product in compliance with all
applicable laws, rules, regulations and court or administrative orders and
processes, cGMP as in effect at the time of manufacture, Product specifications,
Regulatory Approvals and Drug Master Files relating to the Product. Except as
disclosed on Sections 6.08 and 6.10(b) of the Seller Disclosure Schedule, Seller
has not received any written notice of violation of any applicable law,
regulation or requirement relating to the Product or the Purchased Assets within
the past five years. (c) Seller has operated the Business in the ordinary course
so as to preserve the Business intact and to preserve the Business and the
goodwill of Seller's suppliers, customers, distributors and others having
business relations with it.
SECTION 6.12 SUPPLIERS AND MANUFACTURERS.
Except as set forth on Section 6.12 of the Seller Disclosure Schedules,
Seller has not received any notice or has any valid reason to believe that any
such supplier or manufacturer will not sell Product to the Seller at any time
after the Closing on terms and conditions substantially similar to those
currently in effect, subject only to the terms and conditions set forth in any
Contract between any such supplier or manufacturer and Seller.
SECTION 6.13 INVENTORY.
The Product Inventory was acquired and has been maintained in accordance
with the regular business practices of Seller, consists of new and unused items
of a quality and quantity usable or saleable in the Ordinary Course of Business.
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SECTION 6.14 ASSUMPTION OF ONGOING CLINICAL TRIALS.
There are no ongoing clinical trials involving the Product as of the
Closing Date.
SECTION 6.15 BROKERS.
Seller has not retained any broker in connection with the transactions
contemplated hereunder. Buyer has no, and will have no, obligation to pay any
brokers, finders, investment bankers, financial advisors or similar fees in
connection with this Agreement or the transactions contemplated hereby by reason
of any action taken by or on behalf of Seller.
SECTION 6.16 DISCLOSURE.
None of the representations or warranties made by the Seller herein as
of the date of such representations and warranties, and none of the statements
contained in any other written materials with respect to the Purchased Assets
furnished by Seller to Buyer in connection with this Agreement, contains any
untrue statement of a material fact or omits any material fact required to be
stated therein or necessary to make the statements made therein, in light of the
circumstances under which they were made, not misleading.
SECTION 6.17 BOOKS AND RECORDS.
Seller has made and kept Books and Records and accounts, which, in
reasonable detail, accurately and fairly reflect the activities of Seller with
respect to the Purchased Assets.
SECTION 6.18 NO OTHER AGREEMENTS TO SELL THE ASSETS.
None of Seller or any of its officers, directors, shareholders or
Affiliates have any commitment or legal obligation, absolute or contingent, to
any other Person or firm other than Buyer to sell, assign, transfer or effect a
sale of any of the Purchased Assets (other than inventory in the Ordinary Course
of business) or to enter into any agreement or cause the entering into of an
agreement with respect to any of the foregoing.
SECTION 6.19 NO OTHER WARRANTIES.
EXCEPT AS SET FORTH IN THIS ARTICLE VI, SELLER IS SELLING THE PURCHASED
ASSETS AND PRODUCT INVENTORY HEREUNDER ON AN "AS IS" BASIS WITHOUT
REPRESENTATION OR WARRANTY AS TO THE PRODUCT, THE PRODUCT INVENTORY, THE
PURCHASED ASSETS OR THE BUSINESS WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD
PARTY RIGHTS.
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ARTICLE VII
REPRESENTATIONS AND WARRANTIES OF BUYER
Buyer represents and warrants to Seller as of the date hereof, subject
to such exceptions as are specifically disclosed in the disclosure schedule
(referencing the appropriate Sections hereof) supplied by Buyer to Seller and
dated as of the date hereof (the "Buyer Disclosure Schedule"), which Buyer
Disclosure Schedule shall be deemed to be representations and warranties of
Buyer as if made herein, as follows:
SECTION 7.01 CORPORATE ORGANIZATION.
Buyer is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware and has all requisite power and
authority to own its assets and carry on its business as currently conducted by
it. Buyer is duly authorized to conduct its business and is in good standing in
each jurisdiction where such qualification is required, except for any
jurisdiction where failure to so qualify could not reasonably be expected,
individually or in the aggregate, to have a material adverse effect on Buyer or
materially impair or delay Buyer's ability to perform its obligations hereunder.
SECTION 7.02 AUTHORITY OF BUYER.
Buyer has all necessary power and authority and has taken all actions
necessary to enter into this Agreement and to carry out the transactions
contemplated hereby. The Board of Directors of Buyer has taken all action
required by Law, its Certificate of Incorporation, Bylaws or otherwise to be
taken by it to authorize the execution and delivery of this Agreement by Buyer
and the consummation of the transactions contemplated hereby. This Agreement has
been duly and validly executed and delivered by Buyer and, when executed and
delivered by Seller, will constitute a legal, valid and binding obligation of
Buyer enforceable against it in accordance with its terms except (a) as limited
by applicable bankruptcy, insolvency, reorganization, moratorium and other laws
of general application affecting enforcement of creditors rights generally, and
(b) as limited by laws relating to the availability of specific performance,
injunctive relief or other equitable remedies.
SECTION 7.03 CONSENTS AND APPROVALS.
(a) All consents, waivers, approvals, Orders, authorizations of,
declarations or filings with any Governmental or Regulatory Authority (each a
"Buyer Governmental Consent") that are required by or with respect to Buyer in
connection with the execution and delivery of this Agreement by Buyer, and its
performance of its obligations hereunder are set forth on Schedule 7.03(a). Each
Buyer Governmental Consent has been obtained, except to
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the extent that the failure to obtain such Buyer Governmental Consent would not
have an Adverse Effect.
(b) All consents, waivers, approvals, authorizations of, or
notices to, any third party (other than a Governmental or Regulatory Authority)
(each a "Buyer Third Party Consent") that are required by or with respect to
Buyer in connection with the execution and delivery of this Agreement by Buyer,
and its performance of its obligations hereunder are set forth on Schedule
7.03(b). Each Buyer Third Party Consent has been obtained, except to the extent
that the failure to obtain such Buyer Third Party Consent would not have an
Adverse Effect.
SECTION 7.04 NON-CONTRAVENTION.
The execution and delivery by Buyer of this Agreement does not, and the
performance by it of its obligations under this Agreement and the consummation
of the transactions contemplated hereby will not:
(a) conflict with or result in a violation or breach of any of
the terms, conditions or provisions of the Certificate of Incorporation, Bylaws
or other organizational documents of Buyer;
(b) conflict with or result in a violation or breach of any term
or provision of any Law applicable to Buyer other than such conflicts,
violations or breaches as would not have an Adverse Effect; or
(c) conflict with or result in a breach or default (or an event
which, with notice or lapse of time or both, would constitute a breach or
default) under, or result in the termination or cancellation of, or accelerate
the performance required by, or result in the creation or imposition of any
security interest, lien or any other Encumbrance (other than a Permitted
Encumbrance) upon any Contract to which Buyer is a party or by which Buyer or
any of its assets is bound, other than such conflicts, breaches or defaults as
would not have an Adverse Effect.
SECTION 7.05 LITIGATION.
There are no Actions or Proceedings pending, or to the Knowledge of
Buyer threatened or reasonably anticipated, against, relating to, affecting or
arising in connection with (i) this Agreement or (ii) the transactions
contemplated by this Agreement. Buyer is not subject to any Order that could
reasonably be expected to materially impair or delay the ability of Buyer to
perform its obligations hereunder.
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SECTION 7.06 BROKERS.
Buyer has not retained any broker in connection with the transactions
contemplated hereunder. Seller has no, and will have no, obligation to pay any
brokers, finders, investment bankers, financial advisors or similar fees in
connection with this Agreement or the transactions contemplated hereby by reason
of any action taken by or on behalf of Buyer.
ARTICLE VIII
COVENANTS OF THE PARTIES
SECTION 8.01 NON-ASSERTION OF INTELLECTUAL PROPERTY RIGHTS.
(a) Seller agrees that neither it nor any Affiliate will assert
against Buyer, under any patent, trade secret, copyright, trademark or other
proprietary right owned or controlled by Seller and used by Seller in the
operation of the Business as of the Closing, a claim that the Product or the
operation of the Business, infringes such rights owned or controlled by Seller
or its Affiliates, excluding, however, the Elan tradename and the Elan trademark
and logo upon the exhaustion of the Product Inventory.
(b) Buyer agrees that it will not alter or deface the Elan
tradename or the Elan trademark and logo in operation of the Business while
exhausting the Product Inventory.
(c) Buyer further agrees that it will maintain the same quality
of the Product as used by Seller in the operation of the Business as of the
Closing for any Product sold under the Elan tradename and Elan trademark and
logo and will do nothing to diminish the value of the Elan tradename and Elan
trademark and logo.
SECTION 8.02 COOPERATION.
Each Party shall cooperate fully with the other in preparing and filing
all notices, applications, submissions, reports and other instruments and
documents that are necessary, proper or advisable under applicable Laws to
consummate and make effective the transactions contemplated by this Agreement,
including Seller's cooperation in the efforts of Buyer to obtain any consents
and approvals of any Governmental or Regulatory Authority required for Buyer to
be able to own the Purchased Assets. Each Party shall cooperate fully with the
other in connection with the delivery to Buyer of physical possession of all
tangible personal property included in the Purchased Assets.
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SECTION 8.03 ACCESS.
(a) Upon the request of Seller, Buyer shall for a period of (5)
years following the Closing to the extent permitted by Law, grant to Seller and
its representatives the right, during normal business hours, to inspect and copy
the Books and Records and other documents in Buyer's possession to the extent
pertaining to the operation of the Business prior to the Closing Date for Tax
purposes and in connection with Actions or Proceedings.
(b) For a period of five (5) years following the Closing, Buyer
agrees to keep and maintain all Books and Records and other documents in
existence on the Closing Date and make personnel of Buyer or its Affiliates
available to Seller or its representatives to the extent such access is
reasonably related to any Excluded Assets or otherwise necessary for Seller to
comply with or enforce the terms of this Agreement or comply with any applicable
Law; it being understood that Seller shall reimburse Buyer promptly for its
reasonable and necessary out of pocket expenses incurred in complying with any
such request by or on behalf of Seller.
SECTION 8.04 PUBLIC ANNOUNCEMENTS.
Neither Seller nor Buyer shall issue any press release or make any
public announcement with respect to this Agreement and the transactions
contemplated hereby without obtaining the prior written consent of the other
Party.
SECTION 8.05 NON-SOLICITATION.
Each Party (the "Soliciting Party") agrees that, without the prior
written consent of the other Party (the "Non-soliciting Party"), for a period
commencing on the date hereof and expiring on the second (2nd) anniversary of
the Closing Date, the Soliciting Party will not directly or indirectly (a)
induce, encourage or solicit any officer or employee of the Non-soliciting Party
or any of its Affiliates to leave such employment or to accept any other
position or employment with the Soliciting Party or (b) assist any Affiliate or
representative of the Soliciting Party in hiring such employee. However, nothing
in this Section 8.05 shall prohibit the Soliciting Party from indirectly
inducing, encouraging or soliciting such officers or employees to leave the
Non-soliciting Party through the use of general advertisements in trade journals
and the like.
SECTION 8.06 CORPORATE NAMES.
(a) Except as set forth in this Section 8.06, following the
Closing, Buyer shall not have any rights by virtue of this Agreement or any of
the transactions or agreements contemplated hereby to any names, trademarks,
trade names, trade dress or logos relating to
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Seller or any of the Affiliates of Seller or any of their products other than
those included in the Intellectual Property (the "Corporate Names").
(b) Buyer may use in connection with its operation of the
Business following the Closing (until such time, if any, as any Governmental or
Regulatory Authority shall otherwise not permit Buyer to do so), items of
Product Inventory that bear any of the Corporate Names, it being understood that
Buyer will use its reasonable best efforts to use or sell such items of Product
Inventory prior to selling any other product under the trademark or trade name
of the Product.
(c) Buyer may use Marketing Materials that were transferred to
Buyer as Purchased Assets that bear any of the Corporate Names in connection
with its operation of the Business following the Closing and for up to ninety
(90) days thereafter; and thereafter Buyer may use such Marketing Materials only
if Buyer completely removes all Corporate Names from, or completely covers all
Corporate Names on, such materials. Buyer acknowledges and agrees that Seller
shall have no Liability or other obligation arising out of or in connection with
Buyer's or it Affiliate's use of the Marketing Materials.
SECTION 8.07 PRODUCT INVENTORY.
From and after the Closing, Buyer shall hold, store, and ship any
Product Inventory substantially in accordance with (i) all applicable Laws, (ii)
current cGMPs, (iii) the applicable Regulatory Approvals, and (iv) applicable
analytical methods and procedures, material specifications, master batch
records, and stability protocols.
SECTION 8.08 DIFFERENTIATION OF PRODUCTS.
From and after the Closing, Buyer shall use commercially reasonable
efforts to promptly institute appropriate procedures to ensure that products and
goods of the Business manufactured, finished or sold by, or on behalf of, Buyer
can be distinguished from products and goods manufactured, finished or sold by,
or on behalf of, Seller and its Affiliates; provided, however, Buyer shall not
be obligated to change in any way any trademark or logo specifically relating to
"Midrin."
SECTION 8.09 REGULATORY MATTERS.
(a) The transfer by Seller to Buyer of each Regulatory Approval
pursuant to the terms hereof shall be at Seller's cost; provided that after such
transfer, Buyer shall be solely responsible and liable for (i) taking all
actions, paying all fees and conducting all communication with the appropriate
Governmental or Regulatory Authority required by Law in respect of such
Regulatory Approval, including preparing and filing all reports (including
adverse drug experience reports) with the appropriate Governmental or Regulatory
Authority,
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and (ii) taking all actions and conducting all communication with third parties
in respect of Product sold pursuant to such Regulatory Approval (whether sold
before or after transfer of such Regulatory Approval), including responding to
all complaints in respect thereof, including complaints related to tampering or
contamination, and (iii) investigating all complaints and adverse drug
experiences in respect of Product sold pursuant to such Regulatory Approval
(whether sold before or after transfer of such Regulatory Approval). Seller
shall cooperate with Buyer's reasonable requests and use commercially reasonable
efforts to assist Buyer in connection with any of the foregoing.
(b) From and after the transfer by Seller to Buyer of each
Regulatory Approval pursuant to the terms hereof, Seller promptly (and in any
event within the time periods required by law) shall notify Buyer if Seller
receives a complaint or a report of an adverse drug experience in respect of a
Product sold pursuant to such Regulatory Approval. In addition, Seller shall
cooperate with Buyer's reasonable requests and use commercially reasonable
efforts to assist Buyer in connection with the investigation of and response to
any complaint or adverse drug experience related to a Product sold by Seller or
its Affiliates.
(c) From and after the transfer by Seller to Buyer of each
Regulatory Approval pursuant to the terms hereof, Buyer, at its cost, shall be
solely responsible and liable for conducting all voluntary and involuntary
recalls of units of Product sold pursuant to such Regulatory Approval (whether
sold before or after transfer of such Regulatory Approval), including recalls
required by any Governmental or Regulatory Authority and recalls of units of
Product sold by Seller or its Affiliates deemed necessary by Buyer in its
reasonable discretion; provided, however, that in the event that any such recall
is attributable to Product sold by Seller or its Affiliates prior to the
Closing, then Seller shall reimburse Buyer for all reasonable expenses in
connection with the recall of such Product. Each Party promptly (and in any
event within the time periods required by law) shall notify the other Party in
the event that a recall of Product sold by Seller or its Affiliates is
necessary.
SECTION 8.10 PRODUCT RETURNS, CHARGEBACKS AND REBATES.
(a) Product Returns. Seller will, at its sole cost and expense,
process and issue credits (or render payment in such other form as
Seller may determine) for all returned Product bearing Seller's NDC
numbers, unless sold by Buyer after the Closing, in which case Buyer
shall be responsible for handling such returns. Such handling of
returned Products by Seller, and the issuance of any credits or other
form of reimbursement in connection therewith, shall be in accordance
with Seller's returned goods policy in effect on the Closing. Buyer will
process, and be solely responsible for reimbursements with respect to
Product returns arising with respect to, or resulting from, shipping
errors, damage in transit and shortages relating to Buyer's sales of
Products after the Closing and Product with Buyer's NDC number.
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(i) Except as otherwise provided herein, Buyer and
Seller will not xxxx one another for costs incurred strictly for the
processing of claims for returned Products.
(ii) Buyer shall inform Seller as to its policy
regarding the handling and/or destruction of Product returns after the
Closing. Buyer and Seller shall be responsible for the handling of any
Product returned to their respective returns handling facility. If Buyer
or Seller handles Product for which the other was financially
responsible as set forth in this Section, that party shall xxxx the
other party for the cost of such handling. Each such invoice shall set
forth the number of units processed, together with such other
information as shall be necessary to support the invoice. Each party
shall, within thirty (30) days of its receipt of invoice, pay the other
party for the full invoiced amount.
(b) Government Rebates. Seller shall be responsible for all
rebates pursuant to any government rebate program with respect to government
claims for the Products indicating Seller's NDC numbers, unless sold by Buyer
after the Closing, in which case Buyer shall be responsible for such rebates.
Buyer shall reimburse Seller for all rebates that Seller is obligated to pay
with respect to government claims relating to Buyer's sales of Products after
the Closing and Product with Buyer's NDC number. All payments due Seller under
this Section shall be made within thirty (30) days of submission to Buyer of
invoices that describe the requested payments in reasonable detail.
(c) Commercial Rebates. Seller shall be responsible for all
commercial rebates with respect to the Product indicating Seller's NDC numbers,
unless sold by Buyer after the Closing, in which case Buyer shall bear
responsibility for such commercial rebates. Notwithstanding the foregoing, Buyer
and Seller agree that (a) Seller's financial liability for the commercial
rebates after the Closing shall be limited to those commercial customers with
which Seller has a rebate obligation as of the Closing and (b) any such payments
by Seller shall be made on the terms and conditions comparable to Seller's
rebate obligations as of the Closing with respect to each commercial customer
and shall be based on Seller's terms of agreement with the respective contract.
Any rebates relating to Buyer's sales of Products after the Closing and Product
with Buyer's NDC number will be the liability of Buyer. To the extent that
Seller processes such claims, Buyer shall reimburse Seller within thirty (30)
days of receipt of invoices that describe the requested payments in reasonable
detail.
(d) Chargeback Claims. Seller shall be financially responsible
for all chargeback claims for the Products indicating Seller's NDC numbers,
unless sold by Buyer after the Closing, in which case Buyer shall bear such
financial responsibility (the "Transition Chargebacks"). Buyer shall process and
be financially liable for all chargeback claims relating to Buyer's sales of
Products after the Closing and Product with Buyer's NDC number. Buyer and Seller
agree that (a) Seller's financial liability for the Transition Chargebacks shall
be
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limited to those commercial customers with which Seller has chargeback
obligations as of the Closing, and (b) any such chargebacks issued by Seller
shall be made on terms and conditions comparable to Seller's obligations as of
the Closing with respect to each customer and shall be based on Seller's terms
of respective agreements as of the Closing.
(e) Continuing Rebate and Chargeback Obligations. Seller shall
provide Buyer monthly reports in reasonable detail setting forth the amount of
rebates and chargeback claims for which it was financially responsible for the
current month and on a cumulative basis. Seller shall cause its representatives
and employees to be available to Buyer, during normal business hours and upon
reasonable prior written notice to Seller, to discuss any questions or comments
of Buyer concerning such report.
(f) Nonsolicitation of Product Returns. Buyer hereby covenants
to Seller that Buyer shall not solicit Product returns from distribution
channels following the Closing.
SECTION 8.11 ADVERSE EXPERIENCE REPORTS.
At a mutually agreed upon time after the Closing, Seller shall provide
Buyer with information relating to the investigation and reporting of adverse
experiences regarding the Product since the Product launch and all information
which is materially relevant to the safe use of the Product in Seller's
possession as of the Closing. After the Closing, Seller shall promptly submit to
Buyer all adverse drug experience information or customer complaints brought to
the attention of Seller in respect of the Product, as well as any material
events and matters concerning or affecting the safety or efficacy of the
Product. After the Closing, Buyer shall have all responsibility for required
reporting of adverse experiences for the Product.
SECTION 8.12 MULTI-PRODUCT CONTRACTS.
Section 8.12 of the Seller Disclosure Schedule sets forth a complete and
correct list of each Contract to which Seller or any of its Affiliates is a
party and pursuant to which Seller or its Affiliates sells Product, together
with other pharmaceutical products of Seller and its Affiliates, to a third
party (the "Multi-Product Contracts"). Seller has made available to Buyer copies
of all Multi-Product Contracts; provided that such copies have been redacted to
prevent disclosure of information not related to the Product. From and after the
transfer by Seller to Buyer of each Regulatory Approval pursuant to the terms
hereof, Buyer shall honor and perform all obligations and Liabilities of Seller
and its Affiliates under and pursuant to each Multi-Product Contract with
respect to supplying Product to the applicable third party pursuant to such
Regulatory Approval. Seller agrees that after the transfer of such Regulatory
Ap-
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proval it will not take any action with respect to any Multi-Product Contract
that would extend the term of such Multi-Product Contract with respect to any
Product, create or agree to any additional obligations with respect to the
Product, or otherwise adversely affect Buyer or the Business (other than to
terminate any such Multi-Product Contract), without the prior written consent of
Buyer. Seller further agrees that, at the direction of Buyer (to be given
promptly following the Closing), Seller shall either terminate or assign to
Buyer the rights and obligations with respect to the Product under each such
Multi-Product Contract, to the extent permitted by the terms thereof, as soon as
practicable after obtaining Buyer's direction.
SECTION 8.13 MANNER OF BUSINESS.
From and after the Closing Date, Buyer shall not, by any action or
omission cause sales of the Product to occur later than they would otherwise
have occurred during the ordinary course of business or cause returns of the
Product to occur earlier than they would otherwise have occurred.
SECTION 8.14 COMPLIANCE AUDITS.
From time to time as either Party may elect during the period commencing
with the Closing Date and ending on December 31, 2002 (except in the case of
Seller in connection with any Royalty Payment, which period shall extend until
no further Royalty Payments are due Seller from Buyer in connection with this
Agreement), during normal business hours and upon reasonable prior written
notice to the other Party, each Party shall permit duly authorized
representatives of the other Party to review and inspect the premises,
facilities, inventory, records and documentation maintained by the other Party
for the purpose of determining compliance with the obligations under this
Agreement.
SECTION 8.15 LABELING REQUIREMENTS.
Following the Closing, Buyer shall at its own expense and as
expeditiously as possible use all reasonable efforts to obtain Buyer Labeling
for the Product to be manufactured after the Closing.
SECTION 8.16 FURTHER ASSURANCES.
(a) On and after the Closing, Seller shall from time to time, at
the request of Buyer, (i) execute and deliver, or cause to be executed and
delivered, such other instruments of conveyance and transfer and take such other
actions as Buyer may reasonably request, in order to more effectively consummate
the transactions contemplated hereby and to vest in Buyer good and marketable
title to the Purchased Assets (including assistance in the collec-
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tion or reduction to possession of any of the Purchased Assets) and (ii) use its
commercially reasonable efforts to obtain all consents and waivers and to
resolve all material impracticalities of assignment or transfer necessary to
convey the Purchased Assets to Buyer.
(b) On and after the Closing, Buyer shall from time to time, at
the request of Seller, take such actions as Seller may reasonably request, in
order to more effectively consummate the transactions contemplated hereby,
including Buyer's assumption of the Assumed Liabilities.
ARTICLE IX
CONDITIONS TO THE OBLIGATIONS OF SELLER
The obligation of Seller to effect the transactions contemplated hereby
is subject to the satisfaction (or waiver by Seller), at or before the Closing,
of each of the following conditions:
SECTION 9.01 REPRESENTATIONS, WARRANTIES AND COVENANTS.
All representations and warranties of Buyer contained in this Agreement
shall be true, correct and complete in all material respects on and as of the
Closing Date, as though given on such date, excluding for such purpose any
representations and warranties that are by their terms given only as of a
specific date, and Buyer shall have performed all agreements and covenants
required by this Agreement to be performed by it prior to or on the Closing
Date, and Seller shall have received a certificate to such effect dated the
Closing Date and executed by a duly authorized officer of Buyer.
SECTION 9.02 NO ACTIONS OR PROCEEDINGS.
No Actions or Proceedings that question the validity or legality of the
transactions contemplated hereby shall have been instituted or threatened and
not settled or otherwise terminated.
SECTION 9.03 CONSENTS.
All Seller Governmental Consents, Seller Third Party Consents, Buyer
Governmental Consents and Buyer Third Party Consents shall have been obtained or
made, as the case may be.
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SECTION 9.04 OTHER CLOSING DELIVERIES.
Buyer shall have delivered to Seller such other certificates and
documents customary in transactions similar to those contemplated hereby that
are reasonably requested by Seller.
ARTICLE X
CONDITIONS TO THE OBLIGATIONS OF BUYER
The obligation of Buyer to effect the transactions contemplated hereby
is subject to the satisfaction (or waiver by Buyer), at or before the Closing,
of each of the following conditions:
SECTION 10.01 REPRESENTATIONS, WARRANTIES AND COVENANTS.
All representations and warranties of Seller contained in this Agreement
shall be true, correct and complete in all material respects on and as of the
Closing Date, as though given on and as of such date, excluding for such purpose
any representations and warranties that are by their terms given only as of a
specific date, and Seller shall have performed all agreements and covenants
required by this Agreement to be performed by it prior to or on the Closing
Date, and Buyer shall have received a certificate to such effect dated the
Closing Date and executed by a duly authorized officer of Seller.
SECTION 10.02 NO ACTIONS OR PROCEEDINGS.
No Actions or Proceedings that question the validity or legality of the
transactions contemplated hereby shall have been instituted or threatened and
not settled or otherwise terminated.
SECTION 10.03 CONSENTS.
All Seller Governmental Consents, Seller Third Party Consents, Buyer
Governmental Consents and Buyer Third Party Consents shall have been obtained or
made, as the case may be.
SECTION 10.04 OTHER CLOSING DELIVERIES.
Seller shall have delivered to Buyer an opinion of counsel such other
certificates and documents customary in transactions similar to those
contemplated hereby that are reasonably requested by Buyer.
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ARTICLE XI
INDEMNIFICATION
SECTION 11.01 SURVIVAL OF REPRESENTATIONS, WARRANTIES, ETC.
The representations, warranties and covenants of Seller and Buyer
contained in this Agreement shall survive the Closing and remain in full force
and effect indefinitely; provided, however, that the representations and
warranties of Seller and Buyer set forth in Article VI and Article VII hereof
shall survive the Closing and remain in full force and effect until the
Expiration Date. All representations and warranties contained in Article VI and
Article VII of this Agreement and all claims with respect thereto shall
terminate on the Expiration Date; provided that if notice of any claim for
indemnification pursuant to Section 11.02(a) or 11.02(b) shall have been given
prior to the Expiration Date and such notice describes with specificity the
circumstances with respect to which such indemnification claim relates, such
indemnification claim shall survive until such time as such claim is finally
resolved.
SECTION 11.02 INDEMNIFICATION.
(a) By Seller. Subject to Sections 11.03 and 11.04, from and
after the Closing, Seller shall indemnify, reimburse, defend and hold harmless
Buyer, its Affiliates, and their respective officers, directors, employees,
agents, successors and assigns (collectively, the "Buyer Indemnified Parties")
from and against any and all costs, losses, Liabilities, damages, lawsuits,
deficiencies, claims and expenses (including interest, penalties and reasonable
fees and disbursements of attorneys paid in connection with the investigation,
defense or settlement of any of the foregoing) (collectively, the "Damages"), to
the extent incurred in connection with, arising out of, resulting from or
incident to (i) any inaccuracy or breach of any covenant, representation,
warranty or other agreement of Seller herein, (ii) Seller's conduct of the
Business prior to the Closing, including the development, manufacturing,
marketing, sale or distribution of the Product prior to the Closing; (iii) the
failure of Seller to pay, perform or discharge any Excluded Liabilities; or (iv)
the failure of Seller or the transactions contemplated herein to comply with the
Bulk Sales laws.
(b) By Buyer. Subject to Sections 11.03 and 11.04, from and
after the Closing, Buyer shall indemnify, defend and hold harmless Seller, its
Affiliates and their respective officers, directors, employees, agents,
successors and assigns from and against any and all Damages incurred in
connection with, arising out of, resulting from or incident to (i) any
inaccuracy or breach of any covenant, representation, warranty or other
agreement of Buyer herein, (ii) Buyer's conduct of the Business from and after
the Closing, including the development, manufacturing, marketing, sale or
distribution of the Product from and after the Closing; and (iii) the failure of
Buyer to pay, perform or discharge any Assumed Liabilities.
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(c) Procedures. The indemnified Party (the "Indemnified Party")
shall give the indemnifying Party (the "Indemnifying Party") prompt written
notice (an "Indemnification Claim Notice") of any Damages or discovery of fact
upon which such Indemnified Party intends to base a request for indemnification
under Section 11.02(a) or Section 11.02(b), but in no event shall the
Indemnifying Party be liable for any Damages that result from any delay in
providing such notice. Each Indemnification Claim Notice must contain a
reasonable description of the claim and the nature and amount of such Damages
(to the extent that the nature and amount of such Damages are known at such
time). The Indemnified Party shall furnish promptly to the Indemnifying Party
copies of all papers and official documents received in respect of any Damages.
All indemnification claims in respect of a Party, its Affiliates or their
respective directors, officers, employees and agents (collectively, the
"Indemnitees" and each an "Indemnitee") shall be made solely by such Party to
this Agreement.
(d) Third Party Claims. The obligations of an Indemnifying Party
under this Section 11.02 with respect to Damages arising from claims of any
third party that are subject to indemnification as provided for in Section
11.02(a) or Section 11.02(b) (a "Third Party Claim") shall be governed by and be
contingent upon the following additional terms and conditions:
(i) At its option, the Indemnifying Party may assume the
defense of any Third Party Claim by giving written notice to the
Indemnified Party within thirty (30) days after the Indemnifying Party's
receipt of an Indemnification Claim Notice. The assumption of the
defense of a Third Party Claim by the Indemnifying Party shall not be
construed as an acknowledgment that the Indemnifying Party is liable to
indemnify any Indemnitee in respect of the Third Party Claim, nor shall
it constitute a waiver by the Indemnifying Party of any defenses it may
assert against any Indemnitee's claim for indemnification. Upon assuming
the defense of a Third Party Claim, the Indemnifying Party may appoint
as lead counsel in the defense of the Third Party Claim any legal
counsel selected by the Indemnifying Party that is reasonably acceptable
to the Indemnified Party. In the event the Indemnifying Party assumes
the defense of a Third Party Claim, the Indemnified Party shall promptly
deliver to the Indemnifying Party all original notices and documents
(including court papers) received by any Indemnitee in connection with
the Third Party Claim. Should the Indemnifying Party assume the defense
of a Third Party Claim, except as provided in subsection (ii) below, the
Indemnifying Party shall not be liable to the Indemnified Party or any
other Indemnitee for any legal expenses subsequently incurred by such
Indemnified Party or other Indemnitee in connection with the analysis,
defense or settlement of the Third Party Claim. In the event that it is
ultimately determined that the Indemnifying Party is not obligated to
indemnify, defend or hold harmless an Indemnitee from and against the
Third Party Claim, the Indemnified Party shall reimburse the
Indemnifying Party for any and all costs and expenses (including
attorneys' fees and costs of suit)
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and any Damages incurred by the Indemnifying Party in its defense of the
Third Party Claim with respect to such Indemnitee.
(ii) Without limiting Section 11.02(d)(i), any
Indemnitee shall be entitled to participate in, but not control, the
defense of such Third Party Claim and to employ counsel of its choice
for such purpose; provided, however, that such employment shall be at
the Indemnitee's own expense unless (A) the employment thereof has been
specifically authorized by the Indemnifying Party in writing, (B) the
Indemnifying Party has failed to assume the defense and employ counsel
in accordance with Section 11.02(d)(1) (in which case the Indemnified
Party shall control the defense) or (C) if the Indemnified Party and the
Indemnifying Party are both named parties to the proceeding and the
Indemnified Party has reasonably concluded that there may be one or more
legal defenses that are different from or in addition to those available
to the Indemnifying Party (in which case the Indemnifying Party shall
not have the right to assume the defense of such action on behalf of the
Indemnified Party and the Indemnifying Party shall be liable for all
legal expenses incurred by the Indemnified Party in furtherance
thereof).
(iii) With respect to any Damages relating solely to the
payment of money damages in connection with a Third Party Claim and that
will not result in the Indemnitee's becoming subject to injunctive or
other relief or otherwise adversely affect the business of the
Indemnitee in any manner, and as to which the Indemnifying Party shall
have acknowledged in writing the obligation to indemnify the Indemnitee
hereunder, the Indemnifying Party shall have the sole right to consent
to the entry of any Judgment, enter into any settlement or otherwise
dispose of such Damages, on such terms as the Indemnifying Party, in its
sole discretion, shall deem appropriate. With respect to all other
Damages in connection with Third Party Claims, where the Indemnifying
Party has assumed the defense of the Third Party Claim in accordance
with Section 11.02(d)(i), the Indemnifying Party shall have authority to
consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Damages; provided that it obtains the prior
written consent of the Indemnified Party (which consent shall not be
unreasonably withheld or delayed). The Indemnifying Party shall not be
liable for any settlement or other disposition of Damages by an
Indemnitee that is reached without the written consent of the
Indemnifying Party (which consent shall not be unreasonably withheld or
delayed). Regardless of whether the Indemnifying Party chooses to defend
or prosecute any Third Party Claim, no Indemnitee shall admit any
liability with respect to, or settle, compromise or discharge, any Third
Party Claim without the prior written consent of the Indemnifying Party.
(iv) Regardless of whether the Indemnifying Party
chooses to defend or prosecute any Third Party Claim, the Indemnified
Party shall, and shall cause each other Indemnitee to, cooperate in the
defense or prosecution thereof and shall
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furnish such records, information and testimony, provide such witnesses
and attend such conferences, discovery proceedings, hearings, trials and
appeals as may be reasonably requested in connection therewith. Such
cooperation shall include access during normal business hours afforded
to the Indemnifying Party to, and reasonable retention by the
Indemnified Party of, records and information that are
reasonably-relevant to such Third Party Claim, and making Indemnitees
and other employees and agents available on a mutually convenient basis
to provide additional information and explanation of any material
provided hereunder, and the Indemnifying Party shall reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in
connection therewith.
(e) Expenses. Except as provided above, the costs and expenses,
including fees and disbursements of counsel, incurred by the Indemnified Party
in connection with any claim shall be reimbursed on a quarterly basis by the
Indemnifying Party, without prejudice to the Indemnifying Party's right to
contest the Indemnified Party's right to indemnification and subject to refund
in the event the Indemnifying Party is ultimately held not to be obligated to
indemnify the Indemnified Party.
SECTION 11.03 LIMITATIONS.
(a) In no event shall Seller be liable for any Damages pursuant
to Section 11.02(a) unless and until the aggregate amount of all such Damages
exceeds One Hundred Thousand Dollars ($100,000.00), in which case Seller shall
be liable for all such Damages in excess of One Hundred Thousand Dollars
($100,000.00); provided that Damages shall not be subject to the limitations set
forth in this Section 11.03(a) to the extent that such Damages are payable in
connection with (i) Seller's breach of Section 8.01; (ii) Seller's failure to
pay Buyer amounts due under Sections 4.01(c), 8.09 and 8.10; and (iii) Seller's
failure to pay or otherwise satisfy any Excluded Liabilities.
(b) In no event shall the aggregate liability of Seller for any
Damages pursuant to Section 11.02(a) (other than Damages due to Seller's failure
to pay or otherwise satisfy any Excluded Liabilities) exceed the Closing
Payment.
(c) The amount of any Damages under Sections 11.02(a) and
11.02(b) shall be reduced by the amount of any insurance proceeds paid to the
Indemnified Party relating to such claim.
(d) Except with respect to claims based on fraud, after the
Closing, the right of the Buyer Indemnified Parties to indemnification under
this Article XI shall be the exclusive remedy of the Buyer Indemnified Parties
with respect to claims incurred in connection with, arising out of, resulting
from or incident to (i) any inaccuracy or breach of any covenant,
representation, warranty or other agreement of Seller herein, (ii) Seller's
conduct of the Business
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prior to the Closing, including Seller's development, manufacturing, marketing,
sale or distribution of the Product prior to the Closing; (iii) the failure of
Seller to pay, perform or discharge any Excluded Liabilities; or (iv) the
failure of Seller or the transactions contemplated herein to comply with the
Bulk Sales laws.
SECTION 11.04 LIMITATION OF LIABILITY.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER
PARTY NOR ANY OF THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY
BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY
OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY
CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR
LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND
WHETHER OCCASIONED BY THE NEGLIGENCE OF SUCH PARTY OR ITS AFFILIATES OR ANY OF
THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS OR REPRESENTATIVES.
ARTICLE XII
MISCELLANEOUS
SECTION 12.01 CONFIDENTIALITY.
(a) In addition to the restrictions contained in Section 8.04,
after the Closing, no Party (a "Disclosing Party") shall, without the prior
written consent of the other Party (the "Non-disclosing Party"), disclose to any
Person Confidential Information (as defined below) of the Non-disclosing Party,
except to a Disclosing Party's employees or representatives who need to know
such information for any reason contemplated by this Agreement (and then only to
the extent that such persons are under an obligation to maintain the
confidentiality of the Confidential Information), or use any Confidential
Information of the Non-disclosing Party for any reason other than contemplated
by this Agreement unless such Disclosing Party has used its best efforts to (i)
consult with the Non-disclosing Party and obtain the Non-disclosing Party's
prior written consent in a timely manner, and (ii) the Disclosing Party has been
advised by counsel that disclosure is required to be made under applicable Law
or the requirements of a national securities exchange or another similar
regulatory body. In the event that the Disclosing Party is requested or required
by documents subpoena, civil investigative demand, interrogatories, requests for
or other similar process to disclose any Confidential Information, the
Disclosing Party shall provide the Non-disclosing Party with prompt written
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notice of such request or demands or other similar process so that the
Non-disclosing Party may seek an appropriate protective order or, if such
request, demand or other similar process is mandatory, waive the Disclosing
Party's compliance with the provisions of this Section 12.01 (a) as appropriate.
(b) The term "Confidential Information" as used in this Section
12.01 means (i) as to Buyer, all confidential information relating to Buyer's
business, the Purchased Assets and the Assumed Liabilities, and (ii) as to
Seller, all confidential information relating to the Business (other than the
Purchased Assets) and the business and operations of the Seller and its
Affiliates, including the Excluded Assets and the Excluded Liabilities or other
obligations other than the Assumed Liabilities, in each of (i) and (ii) whether
disclosed prior to or after the date hereof. The term "Confidential Information"
does not include information which becomes generally available to the public
other than as a result of disclosure by the Disclosing Party, or becomes
available to the Disclosing Party on a non-confidential basis from a source
other than the Non-disclosing Party, provided that such source is not bound by a
confidentiality agreement with the Non-disclosing Party.
(c) This Section 12.01 supersedes and replaces in its entirety
that certain letter agreement relating to confidentiality between Seller or its
Affiliate and Buyer relating to the Product and the Business.
SECTION 12.02 NOTICES.
All notices, requests and other communications hereunder must be in
writing and will be deemed to have been duly given only if delivered personally
against written receipt or by facsimile transmission with answer back
confirmation or mailed (postage prepaid by certified or registered mail, return
receipt requested) or by nationally recognized overnight courier that maintains
records of delivery to the Parties at the following addresses or facsimile
numbers:
If to Buyer to: Women First Healthcare, Inc.
00000 Xx Xxxxxx Xxxx
Xxxxx 000
Xxx Xxxxx, XX 00000
Attention: President and CEO
Facsimile: (000) 000-0000
With copies to: Xxxxxx & Xxxxxxx
000 "X" Xxxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxxx X. Xxxxx, Esq.
Facsimile: (000) 000-0000
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If to Seller to: Elan Pharma International Limited
WIL House
County Clare, Shannon, Ireland
ATTN: Director
Phone: 000-000-0000-0000
Elan Pharmaceuticals, Inc.
000 Xxxxxxx Xxxxxxxxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Attention: Vice President Legal Affairs
Facsimile: (000) 000-0000
With copies to: Reitler Xxxxx LLC
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxx Xxxxxxx
Facsimile: 000-000-0000
All such notices, requests and other communications will (i) if
delivered personally to the address as provided in this Section, be deemed given
upon receipt, (ii) if delivered by facsimile to the facsimile number as provided
in this Section, be deemed given upon receipt by the sender of the answer back
confirmation and (ii) if delivered by mail in the manner described above or by
overnight courier to the address as provided in this Section, be deemed given
upon receipt (in each case regardless of whether such notice, request or other
communication is received by any other Person to whom a copy of such notice,
request or other communication is to be delivered pursuant to this Section). Any
Party from time to time may change its address, facsimile number or other
information for the purpose of notices to that Party by giving notice specifying
such change to the other Parties hereto in accordance with the terms; of this
Section.
SECTION 12.03 ENTIRE AGREEMENT.
This Agreement, together with the (and all Exhibits and Schedules
attached hereto and thereto and all other documents delivered in connection
herewith and therewith) supersedes all prior discussions and agreements among
the Parties with respect to the subject matter hereof and thereof and contains
the sole and entire agreement among the Parties hereto and thereto with respect
to the subject matter hereof and thereof.
SECTION 12.04 WAIVER.
Any term or condition of this Agreement may be waived at any time by the
Party that is entitled to the benefit thereof, but no such waiver shall be
effective unless set forth in a
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written instrument duly executed by or on behalf of the Party waiving such term
or condition. No waiver by any Party hereto of any term or condition of this
Agreement, in any one or more instances, shall be deemed to be or construed as a
waiver of the same or any other term or condition of this Agreement on any
future occasion. All remedies, either under this Agreement or by law or
otherwise afforded, will be cumulative and not alternative.
SECTION 12.05 AMENDMENT.
This Agreement may be amended, supplemented or modified only by a
written instrument duly executed by each Party hereto.
SECTION 12.06 THIRD PARTY BENEFICIARIES.
The terms and provisions of this Agreement are intended solely for the
benefit of each Party hereto (including, in the case of Seller, Seller's
Affiliates) and their respective successors or permitted assigns and it is not
the intention of the Parties to confer third-party beneficiary rights upon any
other Person.
SECTION 12.07 ASSIGNMENT; BINDING EFFECT.
Neither this Agreement nor any right, interest or obligation hereunder
may be assigned by any Party hereto, other than to an Affiliate, without the
prior written consent of the other Party hereto (which consent shall not be
unreasonably withheld) and any attempt to do so will be void. This Agreement is
binding upon, inures to the benefit of and is enforceable by the Parties hereto
and their respective successors and permitted assigns.
SECTION 12.08 HEADINGS.
The headings used in this Agreement have been inserted for convenience
of reference only and do not define or limit the provisions hereof.
SECTION 12.09 SEVERABILITY.
If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any present or future law, and if the rights or obligations
of any Party hereto under this Agreement will not be materially and adversely
affected thereby, (a) such provision will be fully severable, (b) this Agreement
will be construed and enforced as if such illegal, invalid or unenforceable
provision had never compromised a part hereof, (c) the remaining provisions of
this Agreement will remain in full force and effect and will not be affected by
the illegal, invalid or unenforceable provision or by its severance herefrom,
and (d) in lieu of such illegal, invalid or unenforceable provision, there will
be added automatically as a part of this Agreement a legal, valid and
enforceable provision as similar to terms to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the
Parties hereto.
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SECTION 12.10 GOVERNING LAW.
This Agreement shall be governed by and construed in accordance with the
internal laws of the State of California, without giving effect to principles of
conflicts of laws.
SECTION 12.11 EXPENSES.
Except as otherwise provided in this Agreement, each Party hereto shall
pay its own expenses and costs incidental to the preparation of this Agreement
and to the consummation of the transactions contemplated hereby.
SECTION 12.12 CLOSING CONSIDERATION ALLOCATION.
EP and EPIL each hold ownership rights in the Purchased Assets to be sold under
this Agreement, and specifically EP owns the Product Inventory and Marketing
Materials, which will be sold to Buyer for its fair market value as agreed
between EP and Buyer. Upon Closing, EPIL shall deduct such amount from the
Closing Consideration and remit such amount to EP.
SECTION 12.13 COUNTERPARTS.
This Agreement may be executed in any number of counterparts and by
facsimile, each of which will be deemed an original, but all of which together
will constitute one and the same instrument.
SECTION 12.14 SCHEDULES, EXHIBITS AND OTHER AGREEMENTS.
The exhibits, schedules, other agreements, certificates and notices
specifically referred to herein, and delivered pursuant hereto, are an integral
part of this Agreement. Any disclosure that is made in any of the schedules or
certificates delivered pursuant to this Agreement in such a way as to make its
relevance to the information called for by such other schedule or certificate
reasonably apparent shall be deemed responsive to any other applicable
disclosure obligation hereunder.
[Signature Page Follows]
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IN WITNESS WHEREOF, each of the undersigned has duly executed this
Agreement as of the date first written above.
WOMEN FIRST HEALTHCARE, INC.
By:
-------------------------------------
Name:
Title:
ELAN PHARMA INTERNATIONAL LIMITED
By:
-------------------------------------
Name:
Title:
ELAN PHARMACEUTICALS, INC.
By:
-------------------------------------
Name:
Title:
