Exhibit 10.21
[******] DENOTES INFORMATION OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT UNDER TO RULE 406
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this "AGREEMENT") dated as of September 29,
2005 by and between Anthra Pharmaceuticals, Inc., a Delaware corporation
("SELLER"), and Valera Pharmaceuticals, Inc., a Delaware corporation ("BUYER").
BACKGROUND
Seller was engaged in the business of developing, manufacturing and selling
pharmaceutical products that utilized Valrubicin (as defined in Section 1) as
the active ingredient including a product marketed in the United States under
the trademark Valstar(R) (the "BUSINESS"). The production, marketing and sale of
Valstar was halted due to a manufacturing issue. Buyer desires to purchase from
Seller, and Seller desires to sell, transfer and assign to Buyer, certain assets
and rights associated with the Business in the United States and Canada
including, without limitation, any and all of Seller's rights to manufacture,
market, distribute and sell in the United States and Canada pharmaceutical
products that have Valrubicin as the active ingredient, and in connection
therewith Buyer has agreed to assume certain liabilities associated with the
future operation of the Business in the United States and Canada, all on the
terms and conditions of this Agreement.
TERMS
NOW THEREFORE, in consideration of the representations and warranties,
covenants and conditions set forth herein, and intending to be legally bound
hereby, Buyer and Seller agree as follows:
1. Definitions. The following terms, as used herein, have the following
meanings:
"ACQUIRED ASSETS" has the meaning set forth in Section 2.1.
"ACQUIRED CONTRACTS" means the agreements described in paragraph (k) of
Exhibit A.
"ACTUAL KNOWLEDGE OF SELLER" means the actual (and not constructive or
imputed) knowledge of the directors of Seller (without independent investigation
or inquiry).
"ACTUAL KNOWLEDGE OF BUYER" means the actual (and not constructive or
imputed) knowledge of the directors and officers of Buyer (without independent
investigation or inquiry).
"AFFILIATE" means, with respect to a Party, any entity controlling,
controlled by or
under common control with such Party. For purposes of this definition, "control"
means ownership of more than 50% of the outstanding voting securities of the
entity or the power to direct the management and policies of the entity, whether
by ownership of securities, contract or otherwise.
"ASSUMED LIABILITIES" has the meaning set forth in Section 2.2.
"XXXX OF SALE AND ASSIGNMENT" has the meaning set forth in Section 2.1.
"BUSINESS DAY" means any Monday, Tuesday, Wednesday, Thursday or Friday,
other than any such day on which the Federal Reserve Bank of New York is closed.
"CELLTECH" means a UK company registered number 2159282 whose main address
is 000 Xxxx Xxxx, Xxxxxx, Xxxxxxxxx, XX0 0XX, XX and its subsidiaries and
affiliates.
"CELLTECH DEVELOPMENT AGREEMENT" means the development agreement, dated as
of July 15, 1997, between Seller and Celltech, as the assignee of Medeva
California Inc. (as such agreement may have been amended).
"CLOSING" has the meaning set forth in Section 3.1.
"CLOSING DATE" has the meaning set forth in Section 3.1.
"COMMERCIAL SALE" means, with respect to a particular Product, the sale by
or on behalf of the Marketers for use or consumption by the general public of
such Product, provided, however, that sales of such Product for research,
development, clinical trials, investigation and/or evaluation shall not be
deemed sales for use or consumption by the general public.
"CURRENT FORMULATION" means Valrubicin at a concentration of 40 mg/ml in
50% Cremophor(R) EL (polyoxyethyleneglycol triricinoleate)/ 50% dehydrated
alcohol or other formulations that are accepted by the FDA without the
regulatory requirement for a formal clinical study to be submitted in support of
such change in formulation.
"EXCLUDED LIABILITIES" has the meaning set forth in Section 2.3.
"FDA" means the United States Food and Drug Administration and any
successor entity thereto.
"FINANCIAL STATEMENTS" shall mean (a) the audited balance sheet and income
statement of Buyer at December 31, 2003 and December 31, 2004 and the related
statements of operation and cash flows and the statements of changes in
stockholders' equity of the Buyer for the years ended December 31, 2003 and
December 31, 2004 and the accompanying footnotes thereto, and (b) the balance
sheet and income statement of Buyer as of August 31, 2005 for the eight (8)
month period then ended. Copies of the Financial Statements are attached hereto
as Exhibit D.
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"GOVERNMENTAL BODY" means any federal, state, municipal or other
governmental department, commission, board, bureau, court, agency, authority or
instrumentality, domestic or foreign.
"INCLUDED INDICATIONS" means BCG-refractory carcinoma-in-situ (CIS) of the
bladder.
"INTELLECTUAL PROPERTY" has the meaning set forth in Section 4.5.
"IRS" means the Internal Revenue Service.
"LICENSE AGREEMENT" means an agreement (or, if more than one agreement, the
combination of agreements) between Buyer and a Third Party in which Buyer grants
such Third Party the right to make, use or sell a Product or Valrubicin. A
License Agreement may also involve the supply of a Product or Valrubicin by
Buyer to the Third Party.
"LICENSE FEES" means, with respect to the License Agreement with Paladin
Labs and any arrangement pursuant to which Buyer provides Valrubicin or the
Product to any Third Party other than a Marketer or Paladin Labs, or in respect
of which License Fee Buyer has a payment obligation owing to Seller that is not
considered to be payable pursuant to Section 2.5(a)(i) or (a)(ii) hereof, the
excess of (i) the proceeds received by Buyer under the License Agreement
(including, without limitation, marketing fees, license fees, commission fees,
and option fees but specifically excluding research and development fees and
proceeds from sales of Product by Buyer to any Third Party, but in no case
reduced by taxes on net or gross income), over (ii) the direct "cost of goods
sold" allocable to supplies of Valrubicin or the Product so provided by Buyer
(exclusive of overhead), calculated in accordance with GAAP and in the manner
reflected in Buyer's Financial Statements.
"MARKETERS" means Buyer, its Affiliates, licensees pursuant to a License
Agreement (other than Paladin Labs), or permitted transferees or assignees.
"NDA" means the New Drug Application relating to Valrubicin approved by the
FDA on September 25, 1998.
"NET SALES" means the total gross sales invoiced and collected by the
Marketers with respect to the Commercial Sale of the Product on a worldwide
basis for use in any indication by the Marketers less the aggregate of: (i)
normal and customary returns, rebates, recalls, chargebacks and discounts (such
as those granted or required pursuant to arrangements with Medicare, Medicaid
and other third party payors), in each case actually allowed and taken; (ii)
freight, transport and delivery, including insurance (if separately identified
on the invoice); and (iii) any sales tax, value added tax, goods and services
tax or any other tax, customs or duties that may be imposed on the sale of the
Product, which taxes, customs or duties are included in gross sales invoiced,
but not including any taxes assessed against income derived from such sales.
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"NEW FORMULATIONS" means any formulation of Valrubicin other than the
Current Formulation.
"OTHER INDICATIONS" means all indications other than Included Indications
approved by the FDA.
"PALADIN LABS" means Paladin Labs Inc.
"PARTY" means Seller or Buyer, as the context requires.
"PERSON" means any natural person, corporation, general partnership,
limited partnership, limited liability company, proprietorship, joint venture,
trust, association, union, entity, or other form of business organization or any
governmental body whatsoever.
"PRF" means Xxxx Royalty Fund, L.P., a Delaware limited partnership.
"PURCHASE PRICE" has the meaning set forth in Section 2.4.
"PRODUCT" means any and all dosage forms of any finished product that has
Valrubicin as its active ingredient.
"REGULATORY APPROVALS" means the technical, medical and scientific
licenses, registrations, authorizations, permits, certificates, consents,
confirmations, clearances and approvals (including the prerequisite
manufacturing approvals or authorizations, marketing authorizations based upon
such approvals and labeling approvals related thereto) that are required by any
Regulatory Authority for the manufacture, distribution, marketing, storage,
transportation, use and sale of Valrubicin in the territory over which the
Regulatory Authority has jurisdiction.
"REGULATORY AUTHORITY" means the FDA or the comparable Governmental Body of
another country or jurisdiction having regulatory oversight over matters similar
to that of the FDA.
"SALE OF THE PRODUCT" means a transaction in which Buyer receives up-front
or any other consideration for the sale, license or grant of co-promotion rights
of the Product, other than royalties or transfer fees in respect of the sale or
distribution of the Product.
"TRANSACTION DOCUMENTS" has the meaning set forth in Section 4.1.
"TAX RETURNS" means any return, declaration, report, claim for refund, or
information return or statement relating to Taxes, including any schedule or
attachment thereto, and including any amendment thereof.
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"TAX" means any federal, state, local or foreign income, gross receipts,
license, payroll, employment, excise, severance, stamp, occupation, premium,
windfall profits, environmental, customs duties, capital stock, franchise,
profits, withholding, social security (or similar), unemployment, disability,
real property, personal property, sales, use, transfer, registration, value
added, alternative or add-on minimum, estimated, or other tax of any kind
whatsoever, including any interest, penalty, or addition thereto, whether
disputed or not.
"THIRD PARTY" means any person or entity other than Buyer, Seller or their
respective Affiliates.
"VALRUBICIN" means the compound commonly known as N-Trifluoroacetyl
adriamycin-14-valerate whose Chemical Abstracts registry number is 00000-00-0.
2. Sale and Purchase of Assets.
2.1 Acquired Assets. Subject to the terms and conditions of this Agreement,
at the Closing and in consideration of the payments made or to be made by Buyer
to Seller as described herein, Buyer agrees to purchase and accept from Seller
and Seller agrees to convey, sell, transfer, assign and deliver to Buyer, all of
Seller's right, title and interest in and to the assets, properties and
privileges set forth on Exhibit A hereto and in the Xxxx of Sale and Assignment
(the "XXXX OF SALE AND ASSIGNMENT") attached as Exhibit B hereto (such assets,
properties and privileges are hereinafter referred to as the "ACQUIRED ASSETS").
2.2 Assumed Liabilities. Subject to the terms and conditions of this
Agreement, at the Closing, Buyer shall assume and agree to pay, perform, fulfill
and discharge the liabilities and obligations described in the Agreement of
Assumption of Liabilities (the "AGREEMENT OF ASSUMPTION OF LIABILITIES")
attached as Exhibit C (such liabilities and obligations being the "ASSUMED
LIABILITIES"). Buyer may, upon providing to Seller documentation that reasonably
substantiates payment of such Assumed Liabilities, offset against amounts
payable to Seller pursuant to Section 2.4(b) and Section 2.5 an amount equal to
Assumed Liabilities actually paid by Buyer up to $250,000.
2.3 Excluded Liabilities. Notwithstanding any provision in this Agreement
or any other writing to the contrary, Buyer is assuming only the Assumed
Liabilities and is not assuming any other liability or obligation of Seller or
any of its respective Affiliates (or any predecessor owner of all or part of its
business and assets) of whatever nature whether presently in existence or
arising or asserted hereafter. Without limiting the generality of the foregoing,
Buyer is not assuming any liability in respect of: (a) products or services
provided by Seller prior to the Closing Date including, without limitation, all
product liability arising out of the development, testing, manufacture,
marketing or sale of the Product or any other product prior to the Closing Date;
(b) any agreements or contracts of Seller that are not Acquired Contracts
including any and all contracts that relate to the licensing, manufacturing,
marketing, distribution or sale of Products outside
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the United States and Canada; or (c) any regulatory or other obligation in
relation to the licensing, manufacturing, marketing, distribution or sale of
Products outside the United States and Canada. All such other liabilities and
obligations shall be retained by and remain obligations and liabilities of
Seller (all such liabilities and obligations not being assumed being herein
referred to as the "EXCLUDED LIABILITIES").
2.4 Purchase Price.
(a) In consideration of the sale, transfer and delivery by Seller to
Buyer of the Acquired Assets and of the other agreements of the parties set
forth herein (including, without limitation, the assumption by Buyer of the
Assumed Liabilities), Buyer agrees to pay to Seller the following amounts
(collectively, the "PURCHASE PRICE"):
(i) US$75,000 upon the execution and delivery of this Agreement
by both Buyer and Seller;
(ii) the amounts payable under Section 2.4(b); plus
(iii) the amounts payable under Section 2.5; plus
(iv) the amounts payable under Section 2.6.
(b) Buyer shall pay the following amounts to Seller:
(i) US$75,000 at the Closing;
(ii) US$150,000 no later than 135 days after the Closing;
(iii) US$150,000 no later than 270 days after the Closing;
(iv) US$150,000 no later than 405 days after the Closing; and
(v) [******] in cash or by wire transfer of immediately
available funds within 10 business days after the calendar
quarter in which there have been [******] in cumulative Net
Sales since the Closing.
2.5 Revenue Share on Net Sales.
(a) Buyer shall also pay to Seller or to Seller's designee an amount
equal to:
(i) 13.5% of Net Sales derived from sales of Product utilizing for
the Current Formulation;
(ii) with respect to Net Sales derived from sales of Product utilizing
New Formulations which sales are made prior to the end of the calendar
quarter during
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which the eighth anniversary of the Closing occurs: (A) 13.5% of Net Sales
of such Product for Included Indications, and (B) [******] of Net Sales of
such Product for Other Indications; provided that if a third party (other
than an Affiliate, successor, licensee or assignee of Buyer) begins
marketing or selling a product using Valrubicin as its active ingredient in
the United States with an approved indication similar to the Included
Indication and it is demonstrated to the reasonable satisfaction of Seller
that such third party achieved during the previous calendar year a market
share of [******], the rates described in clauses (i) and (ii)(A) above
shall be reduced to [******] of Net Sales for the subsequent calendar year
(the percentages of Net Sales so payable by Buyer to Seller under this
Section 2.5(a), the "REVENUE SHARING PERCENTAGE"); and
(iii) [******] of License Fees.
Buyer shall make all payments under this Section 2.5(a) no later than
45 days following the completion of each calendar quarter following the
Closing by wire transfer of immediately available funds to an account
designated by Seller in writing prior to the date on which payment is due.
The amount so remitted on each such date shall equal the Revenue Sharing
Percentage of Net Sales for the immediately preceding calendar quarter. The
total cumulative amount of payments payable under this Section 2.5(a) shall
not exceed US$9,625,000.
(b) Together with each payment required under Section 2.5(a), Buyer
shall furnish to Seller a written report showing: (i) the gross amount
invoiced for Commercial Sales during the most recently completed calendar
quarter; (ii) the gross amount actually collected from Commercial Sales
during the most recently completed calendar quarter; (iii) the deductions
permitted in calculating Net Sales; (iv) the calculation of Net Sales from
Commercial Sales during the most recently completed calendar quarter; (v)
the amount payable to Seller under this Section 2.5 in respect of Net
Sales; (vi) the withholding taxes, if any, required to be deducted in
respect of the amount payable to Seller under this Section 2.5; and (vii)
the amount, if any, of Assumed Liabilities actually paid by Buyer and
offset pursuant to Section 2.2 hereof.
(c) Buyer shall keep complete and accurate records in sufficient
detail to support the calculation of Net Sales and the determination of the
amounts payable under this Section 2.5. Upon the written request of Seller
or PRF and not more than once in each calendar year or more than once as to
any calendar quarter, Buyer shall permit an independent certified public
accounting firm of nationally recognized standing, selected by Seller or
PRF and reasonably acceptable to Buyer, to have access during normal
business hours to such of the records of Buyer as may be reasonably
necessary to verify the accuracy of the reports delivered under Section 2.5
for any calendar quarter ending less than 3 years prior to the date of such
request. The accounting firm shall be required to execute and deliver to
Buyer a non-disclosure agreement in a form reasonably acceptable to Buyer
before Buyer shall be required to give the accounting firm access to its
records. If such accounting firm concludes that additional amounts
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are owed to Seller under this Section 2.5, then Buyer shall pay the
additional amounts within 30 days after the date Seller delivers to Buyer
such accounting firm's written report that describes in reasonable detail
the methods and calculations it used to determine the amounts payable to
Seller under this Section 2.5. Seller shall bear the costs and expenses of
any inspection under this Section 2.5; provided, however, that if the
inspection discloses that Buyer underpaid Seller by more than 5%, then
Buyer shall pay the reasonable fees and expenses charged by the accounting
firm, not to exceed US$25,000.
(d) If the FDA approves an Other Indication, Buyer and Seller will
agree upon a mechanism to track and measure sales from Included Indications
and Other Indications.
2.6 Additional Purchase Price. In addition to the Purchase Price payable to
Seller pursuant to Sections 2.4 and 2.5, if during any calendar year following
the Closing, aggregate Net Sales for such calendar year is equal to [******],
then Buyer shall also pay Seller an amount equal to [******] no later than 45
days after the completion of such calendar year, provided that the aggregate
amount payable under this Section 2.6 shall not exceed [******] (i.e., a maximum
of 4 payments of [******] per year for up to four years in which Net Sales meet
or exceed [******]. To the extent that Buyer has incurred and paid costs
directly associated with clinical studies related to the approval of New
Formulations and/or Other Indications, Buyer shall provide to Seller
documentation detailing such costs. Buyer may offset against amounts payable to
Seller pursuant to this Section 2.6 up to $500,000 of monies payable for such
costs to the extent such costs have not been offset pursuant to Section 2.2
hereof.
2.7 Withholding. If Buyer is required under any applicable law to withhold
any amount due under this Agreement in respect of any taxes payable by Seller,
Buyer may withhold such amounts and pay Seller the balance of the amount due
after such withholding; provided that Buyer promptly pays the amount withheld to
the proper government authority and provides Seller with receipts of such
payment.
2.8 Transfer of Acquired Assets. In the event of a sale by Buyer of the
Acquired Assets (including, without limitation, a Sale of the Product by Buyer),
or the transfer of the Acquired Assets as part of a sale, merger or
consolidation of Buyer, or as part of a transfer of all or substantially all of
the assets of Buyer, all payments payable by Buyer under Sections 2.4(b)(i)-(iv)
shall become immediately due and payable, and except as set forth below, no
consent of Seller to such sale or transfer shall be required. A sale or transfer
of the Acquired Assets by Buyer, other than (a) as part of a sale, merger or
consolidation of Buyer or (b) as part of a transfer of all or substantially all
of the assets of Buyer, shall require the prior written consent of Seller to
such sale or transfer, which consent may not be unreasonably withheld or
delayed. With respect to any transfer of the Acquired Assets (including, without
limitation, as part of a sale, merger or consolidation of Buyer, or as part of a
transfer of all or substantially all of the assets of Buyer), the acquiror or
successor entity, as applicable, shall be required to expressly acknowledge and
assume all obligations of Buyer hereunder unless such assumption occurs by
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operation of law.
2.9 No Marketing Obligations. Seller acknowledges and agrees that: (a)
Buyer has no implied or express obligations to Seller to obtain or maintain any
Regulatory Approval in respect of the Product in any jurisdiction; (b) Buyer has
no implied or express obligations to Seller in respect of the marketing and sale
of the Product including, without limitation, any obligation to use commercially
reasonable, best efforts or other efforts to market and sell the Product; (c)
although Buyer and Seller have discussed in general terms the potential market
for the Product in the United States in treating the Included Indication, Buyer
has made no representations, warranties or guarantees to Seller regarding the
amount of Net Sales that Buyer may achieve in any time period; (d) Buyer is not
in any way obligated to achieve any amount of Net Sales; and (e) Buyer has
complete discretion in determining whether, when and how to market the Product.
2.10 Tax Allocation. By the Closing, Buyer and Seller shall agree to a
written allocation of the Purchase Price (including the amount of any Assumed
Liabilities properly treated for tax purposes as consideration for the Acquired
Assets) among the Acquired Assets, as required under Section 1060 of the
Internal Revenue Code of 1986, as amended (the "ALLOCATION SCHEDULE"). Seller
and Buyer shall follow and use the Allocation Schedule in all Tax Returns,
filings or other related reports made by them to any Governmental Body. To the
extent that disclosures of this allocation are required to be made by the
parties to the IRS under the provisions of Section 1060 of the Internal Revenue
Code of 1986, as amended or any regulations thereunder, Buyer and Seller will
disclose such reports to the other prior to filing with the IRS.
2.11 Transfer Taxes. Buyer shall be responsible for the payment of all
transfer, documentary, sales, use, stamp, registration and other such Taxes and
fees (including any penalties and interest), if any, which may be payable with
respect to the transactions contemplated by this Agreement. Buyer will file all
necessary Tax Returns and other documentation with respect to all such transfer,
documentary, sales, use, stamp, registration and other such Taxes and fees and,
if required by applicable law, Seller will join in the execution of any such Tax
Returns and other documentation. Buyer may offset against amounts payable to
Seller pursuant to Section 2.5(a) hereof any such tax and fees so paid upon
presenting to Seller documentation that reasonably substantiates such payment.
3. Closing.
3.1 Closing. Subject to the terms and conditions of this Agreement, the
consummation of the transactions contemplated by this Agreement ("CLOSING")
shall be held at the offices of Xxxxxx Xxxxxxxx LLP, counsel to Buyer, 000
Xxxxxx Xxxx, 000 Xxxxxxx Xxxx, Xxxxxx, Xxxxxxxxxxxx 00000 on DECEMBER 15, 2005
at 10:00 a.m., or such earlier date that shall be mutually agreed upon by the
parties in writing (the "CLOSING DATE").
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3.2 Conditions to Closing.
(a) The obligations of Buyer and Seller to consummate the Closing are
subject to the satisfaction of the following conditions:
(i) No provision of any applicable law or regulation and no
judgment, injunction, order or decree shall prohibit the consummation
of the Closing.
(ii) Each other party to this Agreement shall have executed and
delivered each of the Transaction Documents to be entered into by it,
in each case substantially in the form attached as an exhibit to this
Agreement, and any other documents or items required to be delivered
by it pursuant to Section 3.3.
(b) The obligation of Buyer to consummate the Closing is subject to
the satisfaction of the following further conditions:
(i) (A) The representations and warranties of Seller contained in
this Agreement at the time of its execution and delivery and in any
certificate or other writing delivered by Seller pursuant hereto,
shall be true and correct in all material respects at and as of the
Closing Date, as if made at and as of such date and (B) Buyer shall
have received a certificate signed by the an authorized signatory of
Seller to the foregoing effect.
(ii) No Governmental Body shall have issued any order and no
proceeding challenging this Agreement or the transactions contemplated
hereby or seeking to prohibit, alter, prevent or materially delay the
Closing shall have been instituted by any Person before any
Governmental Body and be pending.
(iii) Seller shall have received any required consents (i) to the
assignment of each of the agreements listed in Schedule 4.4(c), and
(ii) from each third party having a contractual right to consent to
the transactions contemplated by this Agreement, in each case in form
and substance reasonably satisfactory to Buyer and its counsel, and no
such consent shall have been revoked.
(iv) The existing security agreements between PRF and Seller
shall have been amended to terminate PRF's security interest in the
Acquired Assets, and Seller shall have obtained the Collateral Agent's
signature on any documents necessary to effect such termination.
(v) Buyer shall have performed or complied with in all material
respects all agreements and covenants required by this Agreement to be
performed or complied with by it on or prior to the Closing, and
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Seller shall have received at the Closing a certificate from an
appropriate officer of Buyer to that effect.
(vi) Seller shall have obtained any required approval of
shareholders of Seller to the consummation of the transactions
contemplated by this Agreement..
(vii) The Celltech Development Agreement and any rights or
interests of Celltech pursuant thereto or granted thereunder shall
have been terminated, with a letter agreement from Celltech (or its
successor) indicating that there are no remaining rights or interest
in favor of Celltech or remaining obligations to Celltech (other than
certain payment obligations which may be owed by Seller from payments
received by Buyer under Section 2 of this Agreement) thereunder.
Seller shall have provided Buyer a fully executed copy of such
agreement or instrument terminating the Celltech Development
Agreement.
(viii) Seller shall have delivered to Buyer fully executed
documents, in form and substance reasonably satisfactory to the Buyer
and Buyer's lenders, providing for releases and discharges of all
liens attaching to any of the Acquired Assets.
(ix) The FDA shall not have indicated in writing that it will
require a Phase III clinical trial as a condition to reintroduction of
the Product into the United States for use in the Included Indication;
provided, however, that if the FDA indicates orally on or after
November 10, 2005 that it will require a Phase III clinical trial but
such indication has not been confirmed in writing by the FDA, the
obligation of Buyer to consummate the Closing shall be delayed until
the date that is the earlier of (a) 35 days following the date of such
oral requirement from the FDA, and (b) the business day next
succeeding any retraction or rescission by the FDA, either orally or
in writing, of such oral requirement. If written confirmation from the
FDA regarding imposition of such clinical trial requirement is
received within such 35 day period then Buyer shall not be obligated
under this subsection to consummate the Closing.
(c) The obligation of Seller to consummate the Closing is subject to
the satisfaction of the following further conditions:
(i) [Reserved]
(ii) (A) The representations and warranties of Buyer contained in
this Agreement at the time of its execution and delivery and in any
certificate or other writing delivered by Buyer pursuant hereto, shall
be true and correct in all material respects at and as of the Closing
Date, as if made at and as of such date and (B) Seller shall have
received a certificate signed by the an authorized signatory of Buyer
to the foregoing effect.
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(iii) No Governmental Body shall have issued any order and no
proceeding challenging this Agreement or the transactions contemplated
hereby or seeking to prohibit, alter, prevent or materially delay the
Closing shall have been instituted by any Person before any
Governmental Body and be pending.
(iv) Seller shall have received any required consents to the
assignment of each of the Acquired Contracts, in each case in form and
substance reasonably satisfactory to Seller, and no such consent shall
have been revoked.
(v) There shall not have occurred or be continuing any event or
circumstance which could reasonably be expected to have a material
adverse effect on Buyer, its ability to manufacture, market or
distribute the Product, or its ability to perform its obligations
under this Agreement.
3.3 Deliveries at Closing.
(a) At or prior to the Closing, Seller shall deliver to Buyer the
following:
(i) duly executed Xxxx of Sale and Assignment;
(ii) duly executed Agreement of Assumption of Liabilities;
(iii) such other instruments of sale, transfer, conveyance and
assignment in form and substance reasonably satisfactory to
Buyer and its counsel as Buyer may reasonably request
including, without limitation, assignment agreements with
respect to all patent, trademark and copyright rights of
Seller transferred pursuant hereto, in each case as may be
necessary to vest in Buyer good and marketable title to the
Acquired Assets, free and clear of all liens, claims and
encumbrances;
(iv) copies of all filings with and notifications of Governmental
Bodies and Regulatory Authorities required to be made by
Seller in connection with the execution and delivery of this
Agreement or the consummation of the transactions
contemplated hereby;
(v) a certificate of Seller's Secretary or other authorized
representative certifying as to (a) the resolutions of its
Board of Directors authorizing and approving the execution,
delivery and performance of this Agreement and the
transactions contemplated hereby, and (b) the consent
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of its stockholders to the execution, delivery and
performance of this Agreement and the transactions
contemplated hereby, and (c) the power and authority of the
signatory to each of the Transaction Documents to which
Seller is a party;
(vi) a certificate as to Seller's good standing and legal
existence certified by the Secretary of State of Delaware as
of a date within thirty (30) days of the Closing Date;
(vii) an opinion of counsel to Seller in a form satisfactory to
Buyer with respect to such matters as Buyer shall reasonably
request;
(viii) copies of the consents, evidence of termination and
assignments described in Sections 3.2(b)(iii)) and (iv);
(ix) a letter, executed by an authorized representative of
Seller, addressed to the FDA assigning all rights in the NDA
to Buyer;
(x) a letter, executed by an authorized representative of
Seller, addressed to Health Canada's Therapeutic Products
Directorate assigning all rights in the Canadian regulatory
submission relating to Valrubicin to Buyer; and
(xi) a letter, executed by an authorized representative of
Seller, addressed to each party listed on Schedule 4.11
notifying such party that title to any inventory or
materials in such party's possession belonging to Seller has
been transferred to Buyer.
(b) At or prior to the Closing, Buyer shall deliver to Seller the
following:
(i) duly executed Xxxx of Sale and Assignment;
(ii) duly executed Agreement of Assumption of Liabilities;
(iii) such other instruments of assumption as Seller may
reasonably request;
(iv) the portion of the Purchase Price set forth in Section
2.4(b)(i);
(vi) a certificate as to Buyer's good standing and legal
existence certified by the Secretary of State of Delaware as
of a date
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within 30 days of the Closing Date;
(vii) a certificate of Buyer's Secretary certifying as to (a) the
resolutions of its Board of Directors authorizing and
approving the execution, delivery and performance of this
Agreement and the transactions contemplated hereby, and (b)
the incumbency of its officers; and
(viii) an opinion of counsel to Buyer in form and substance
satisfactory to Seller with respect to such matters as
Seller shall reasonably request.
3.4 Further Assurances. Each of Seller and Buyer shall from time to time
after the Closing at the reasonable request of the other Party and without
further consideration execute and deliver such further instrumentation of
transfer and assignment and assumption as may be reasonably necessary to give
effect to the transactions contemplated hereby.
4. Representations and Warranties by Seller. Seller represents and warrants to
Buyer as follows:
4.1 Organization. Seller is a corporation duly organized, validly existing
and in good standing under the laws of the State of Delaware. Subject to
obtaining any required stockholder or third-party consents, Seller has full
corporate power and authority to execute and deliver this Agreement and all of
the agreements, certificates, instruments and other documents contemplated
herein (collectively, the "TRANSACTION DOCUMENTS") and to carry out its
obligations thereunder. The execution, delivery and, subject to obtaining any
required director, stockholder or third-party consents, performance by Seller of
the Transaction Documents have been duly authorized by all necessary corporate
action of Seller. Each of the Transaction Documents has been duly executed and
delivered by Seller and constitutes the valid and legally binding obligation of
Seller, enforceable against Seller in accordance with its terms, except as such
enforceability may be limited by bankruptcy, insolvency, reorganization or
similar laws of general application affecting the rights and remedies of
creditors and by general equity principles. The execution and delivery of the
Transaction Documents, the compliance with the provisions thereof by Seller, and
the consummation of the transactions contemplated hereby and thereby, will not
(i) conflict with, result in a breach of, constitute (with or without due notice
or lapse of time or both) a default under, result in the acceleration of, create
in any party the right to accelerate, terminate, modify or cancel, or require
any notice, consent or waiver under the certificate of incorporation or by-laws
of Seller or, to the Actual Knowledge of Seller, under any contract, lease,
sublease, sublicense, franchise, permit, indenture, agreement or mortgage for
borrowed money, Security Interest or other interest to which Seller is a party
or by which Seller is bound or to which any of the Acquired Assets are subject,
(ii) result in the imposition of any Security Interest upon any of the Acquired
Assets or (iii) violate any order, writ, injunction, decree, rule or regulation
applicable to Seller or the Acquired Assets, except in each case,
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where such conflict, breach, default or other matter or violation would not have
a material adverse effect on the ability of Buyer to consummate the transactions
contemplated hereby and thereby. For purposes of this Agreement, "SECURITY
INTEREST" means any mortgage, security interest, encumbrance, claim, charge, or
other lien (whether arising by contract or by operation of law).
4.2 Title to Acquired Assets; Condition. Seller owns the Acquired Assets
and Seller has and is conveying to Buyer hereunder, upon delivery to Buyer of
the instruments of transfer referred to in Section 3.3, good and valid title to
the Acquired Assets free and clear of all Security Interests.
4.3 Contracts; Other Documents.
(a) To the Actual Knowledge of Seller, Seller has provided to Buyer or
Buyer has obtained a correct and complete copy of each Acquired Contract
listed on Schedule 1.1(g) to the Xxxx of Sale and Assignment.
(b) To the Actual Knowledge of Seller, Seller has provided to Buyer
copies of all correspondence, agreements and other documents within its
possession related to the sale, manufacture or formulation of Valrubicin,
including but not limited to correspondence and agreements with regulatory
agencies, manufacturers and distributors.
4.4 Consents.
(a) To the Actual Knowledge of Seller, the execution, delivery and
performance by Seller of this Agreement and each of the Transaction
Documents require no actions by or in respect of, or filing with, any
Governmental Body after the Closing other than as listed on Schedule
4.4(a).
(b) To the Actual Knowledge of Seller, there are no governmental
permits, licenses, or other authorizations required as of the Closing Date
in connection with the purchase, ownership, manufacture, operation, use,
maintenance, storage, sale, transportation, shipment or other disposition
of any of the Acquired Assets after the Closing other than as listed on
Schedule 4.4(b).
(c) There are no consents, authorizations or approvals required to
assign the Acquired Contracts other than as set forth in Schedule 4.4(c).
4.5 Intellectual Property. All patents, patent applications, registered
copyrights, trade names, trademarks and trademark applications which are owned
by Seller and related to the Acquired Assets (collectively, the "INTELLECTUAL
PROPERTY") are listed on Schedule 4.5(a). To the knowledge of Seller, Schedule
4.5(b) sets forth a good faith list or description of the unregistered
copyrights being transferred by Seller to Buyer hereunder. To the Actual
Knowledge of Seller, all of Seller's patents and registered trademarks have been
duly registered in, filed in or issued by the applicable patent office of each
country identified in Schedule 4.5(a), and have been properly maintained and
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renewed in accordance with all applicable laws and regulations of each such
country.
To the Actual Knowledge of Seller, the use of the Intellectual Property
owned by Seller does not require the consent of any other Person. All of
Seller's rights to and interest in the Intellectual Property are freely
transferable and are owned exclusively by Seller free and clear of any Security
Interests. Except as set forth on Schedule 4.5(c), to the Actual Knowledge of
Seller, no other Person has an interest in or right or license to use, or right
to acquire or the right to license any other Person to use (whether contingent
or otherwise), any Intellectual Property in the United States and Canada; no
claims or demands of any other Person pertaining thereto have been asserted
against Seller in writing, and no proceedings have been instituted or are
pending or, to the Actual Knowledge of Seller, threatened, which challenge
Seller's rights in respect thereof; to the Actual Knowledge of Seller, none of
the Intellectual Property of Seller is being infringed by another Person, nor
are any of them subject to any outstanding order, decree, ruling, charge,
injunction, judgment or stipulation; and no claim against Seller in writing has
been made, or to the Actual Knowledge of Seller, is threatened, charging Seller
with infringement of any adversely held patent, trademark or copyright or other
intellectual property.
To the Actual Knowledge of Seller, no current or former partner, director,
officer, employee, consultant, independent contractor, stockholder or Affiliate
of Seller (or any predecessor in interest) will, after giving effect to the
transactions contemplated herein, own or retain any rights in or to any of
Seller's Intellectual Property.
4.6 Trade Secrets. To the Actual Knowledge of Seller, (a) Seller has the
right to use, free and clear of any claims or rights of any other Person, all
trade secrets, customer lists and know-how (if any) used by Seller in the
marketing of all products being sold, or under development by it and (b) Seller
is not in any way making an unlawful or wrongful use of any confidential
information, know-how, or trade secrets of any other Person in the marketing of
all products being sold, or under development by Seller.
4.7 Litigation. There is no litigation or governmental or administrative
action, suit, proceeding or investigation (domestic or foreign) pending or, to
the Actual Knowledge of Seller, threatened against Seller with respect to the
Acquired Assets which, if adversely determined, would materially and adversely
affect the Acquired Assets or the marketing, use or sale of the Product.
4.8 Third Party Confidential Information. To the Actual Knowledge of
Seller, in connection with this transaction Seller has not disclosed or
delivered to Buyer any confidential information of any third party except as
otherwise specifically identified to Buyer.
4.9 Insurance. Schedule 4.9 lists all of the active insurance policies
covering Seller for claims arising as a result of the sale or use of Valrubicin.
Seller has furnished to Buyer true and complete copies of all insurance policies
listed in Schedule 4.9. There
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is no claim by Seller pending under any of such policies as to which coverage
has been questioned, denied or disputed by the underwriters of such policies.
All premiums payable under all such policies have been paid and Seller is
otherwise in full compliance with the terms and conditions of all such policies.
Such policies of insurance remain in full force and effect.
4.10 Finders' Fees. There is no investment banker, broker, finder or other
intermediary that has been retained by or is authorized to act on behalf of
Seller who might be entitled to any fee or commission from Buyer, Seller or any
of their respective Affiliates upon consummation of the transactions
contemplated by this Agreement.
4.11 Manufacturing and Formulation. Schedule 4.11 lists each entity that to
the Actual Knowledge of Seller has been involved in the manufacture, formulation
or supply of Valrubicin.
5. Representations and Warranties by Buyer. Buyer represents and warrants to
Seller as follows:
5.1 Organization and Standing. Buyer is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware.
5.2 Authority for Agreement. Buyer has full corporate power and authority
to execute and deliver each of the Transaction Documents and to carry out its
obligations hereunder and thereunder. The execution, delivery and performance of
each of the Transaction Documents and the consummation of the transactions
contemplated hereby and thereby have been duly authorized by all necessary
corporate action of Buyer. Each of the Transaction Documents has been duly
executed and delivered by Buyer and constitutes the valid and binding obligation
of Buyer, enforceable against Buyer in accordance with its terms, except as such
enforceability may be limited by bankruptcy, insolvency, reorganization or
similar laws of general application affecting the rights and remedies of
creditors and to general equity principles.
5.3 Finders' Fees. There is no investment banker, broker, finder or other
intermediary that has been retained by or is authorized to act on behalf of
Buyer who might be entitled to any fee or commission from Buyer, Seller or any
of their respective Affiliates upon consummation of the transactions
contemplated by this Agreement.
5.4 Financial Statements. The Financial Statements have been prepared in
accordance with generally accepted accounting principles and present fairly in
all material respects the financial position and financial results of Buyer as
of the dates and for the periods covered thereby. There has been no Material
Adverse Change since August 31, 2005.
5.5 Material Adverse Effect. To the Actual Knowledge of Buyer, no facts or
circumstances exist that may reasonably be expected to have a material adverse
effect
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upon the Acquired Assets.
5.6 Litigation. There is no litigation or governmental or administrative
action, suit, proceeding or investigation (domestic or foreign) pending or, to
the Actual Knowledge of Buyer, threatened against Buyer which, if adversely
determined, would question the validity of, or could materially and adversely
affect or prevent the consummation of, the transactions contemplated by this
Agreement or any of the other Transaction Documents.
6. Covenants of Seller. Seller agrees that:
6.1 Conduct of the Business. From the date hereof until the Closing Date,
Seller will not sell, lease, license or otherwise dispose of any Acquired Assets
or negotiate for, agree or commit to do any of the foregoing. In addition,
Seller will not knowingly (i) take or agree or commit to take any action that
would make any representation and warranty made by Seller under this Agreement
on the date of its execution and delivery inaccurate in any material respect at,
or as of any time prior to, the Closing Date or (ii) omit or agree or commit to
omit to take any action necessary to prevent any such representation or warranty
from being inaccurate in any respect at any such time.
6.2 Access to Information. From the date hereof until the Closing Date,
Seller shall use reasonable commercial efforts to (a) give Buyer, its counsel,
financial advisors, financing sources, auditors and other authorized
representatives full access to the offices, properties, books and records of
Seller, (b) furnish to Buyer, its counsel, financial advisors, auditors and
other authorized representatives such financial and operating data and other
information relating to Seller as such Persons may reasonably request and (c)
instruct the employees, counsel and financial advisors of Seller to cooperate
with Buyer in its investigation of Seller.
6.3 Notices of Certain Events; Continuing Disclosure.
(a) Until the dissolution of Seller, Seller shall notify Buyer within
15 business days of:
(i) any notice or other communication from any Person that the
consent of such Person is or may be required in connection
with the transactions contemplated by this Agreement;
(ii) any notice or other communication from any Governmental Body
or Regulatory Authority in connection with the transactions
contemplated by this Agreement; and
(iii) any actions, suits, claims, investigations or proceedings
commenced or, to Seller's knowledge threatened against, or
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relating to or involving or otherwise affecting Seller or
that relate to the consummation of the transactions
contemplated by this Agreement, or any material developments
relating to any actions, suits, claims, investigations or
proceedings disclosed pursuant to Section 4.8.
(b) Until the Closing Date, Seller shall have the continuing
obligation promptly to advise Buyer with respect to any matter hereafter
arising or discovered that, if existing or known at the date of this
Agreement, would have been required to be set forth or described in a
Schedule to this Agreement, or that constitutes a breach or prospective
breach of this Agreement by Seller.
(c) No notice pursuant to this Section 6.3 shall affect any
representation or warranty given by Seller hereunder or any of Buyer's
rights under Section 3.2 of this Agreement, nor shall such notice in any
way be deemed to limit or impair the disclosures made to Buyer pursuant to
the schedules hereto. However, if Buyer does close the transaction, the
representations shall be deemed to be modified by the notice for purposes
of Section 7 hereof.
6.4 No Solicitation. Seller agrees that after the signing but prior to the
Closing Date, it shall not, and shall not permit any of its respective officers,
directors, employees, agents or representatives to, solicit, initiate or
encourage (including by way of furnishing any non-public information concerning
the Acquired Assets) inquiries or proposals or engage in discussions or
negotiations (other than with the Buyer) concerning any acquisition or purchase
of the Acquired Assets. Seller shall immediately advise Buyer of any such
inquiry or proposal.
6.5 Corporate Existence. Seller shall maintain its corporate existence
until at least one (1) year after the Closing Date. Upon any dissolution of
Seller, PRF shall be designated as the agent on behalf of the dissolved Seller
and shall be given the sole and exclusive power and authority to act in such
capacity for Seller and its successors and assigns in respect of this Agreement
and, in such capacity, shall receive from Buyer (or its permitted successors or
assigns) any payments due hereunder and shall duly distribute any such amounts
received to successors, assigns, creditors or other parties entitled thereto and
shall receive and retain, subject to the confidentiality provisions hereof, any
Confidential Information contained in a written accountants report delivered to
Seller pursuant to Section 2.5(c) hereof. For the avoidance of doubt, Seller and
PRF shall not share information contained in such accountants report with any of
Seller's investors, stockholders or creditors who are engaged in the
development, manufacture, sale or distribution of pharmaceutical products.
6.6 Cooperation with Seller's Dealings with the FDA. Seller shall cooperate
with Buyer in its attempt to secure the FDA's approval of a plan for the
reintroduction of the Product into the United States market for use in the
Included Indication. Such cooperation shall include: (a) providing Buyer with
all correspondence with the FDA and minutes of meetings and phone calls with the
FDA; (b) permitting Buyer and its attorneys
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and consultants to correspond and meet with the FDA to discuss Buyer's proposed
acquisition of the NDA and Buyer's plan for the reintroduction of the Product
into the United States market for use in the Included Indication; (c) including
Buyer in any teleconferences or meetings between the FDA and Seller regarding
the NDA; (d) upon reasonable prior notice, participation in teleconferences and
in person meetings as requested by Buyer; and (e) making any data or information
in Seller's possession or control relating to stability of the Product available
to Buyer, its consultants and the FDA. Such cooperation shall not include any
responsibility in respect of manufacturing, supplying or testing of validation
or other batches of any Product. Notwithstanding the foregoing, at all times
prior to the Closing Date communications with the FDA regarding the Acquired
Assets, and Buyer's participation in any such meetings, correspondence,
teleconferences or other communications, shall be on such terms as are mutually
satisfactory to Seller and Buyer. Buyer shall pay all expenses incurred in
connection with the obligations under this Section 6.6, provided, however, that
Buyer shall be permitted to offset against payments payable to Seller pursuant
to Section 2.5(a) any such expenses paid by Buyer representing expenses incurred
by Seller pursuant to this Section 6.6.
6A. Covenants of Buyer. Buyer agrees that, during the period within 540
days after the Closing:
6.A.1 Notices.
(a) Buyer shall promptly notify Seller (i) upon entering into any
licensing, distribution or other arrangement relating to distribution of
the Products, or upon receiving notice of any sublicensing by a licensee of
Buyer with respect to the Product, and (ii) of any events or information
related to regulatory or manufacturing matters that could reasonably be
expected to have a material adverse effect on Buyer's ability to distribute
the Product.
(b) Buyer shall provide Seller with written notice as promptly as
practicable (and in any event within five (5) Business Days) after becoming
aware of any of the following:
(i) the entry of an order for relief for Buyer under any
bankruptcy statute; and
(ii) any representation or warranty made or deemed made by Buyer
in any of the Transaction Documents to which it is a party
or in any certificate delivered to Seller pursuant hereto
shall prove to be untrue, inaccurate or incomplete in any
material respect on the date as of which made or deemed
made.
6A.2 Product Sales. Buyer shall not sell Products at reduced prices or
grant
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credits against the purchase prices of the Products to any Person in exchange
for the agreement of such Person or its Affiliate to purchase other products.
Nothing herein shall prohibit Buyer granting price reductions or credits at
levels customarily extended by Buyer.
6A.3 FDA Guidelines. Buyer shall use its best commercially practicable
efforts to comply with all manufacturing guidelines and processes required or
suggested by the FDA.
6A.4 Meetings. If requested by Seller, representatives of each of the Buyer
and the Seller shall discuss such matters relating to the Products as Seller may
reasonably have inquired.
6A.5 Counterparty Reports. Buyer shall (a) cause each License Agreement
that requires License Fees to be paid to Buyer to include a provision that
requires the licensee to deliver on at least a quarterly basis a report
documenting the calculation of the Licensee Fees payable to Buyer under the
License Agreement; (b) cause each agreement to which Buyer is party the payments
under which give rise to any obligation to make payments to Seller pursuant to
Section 2.5(a)(i) or (a)(ii) to include a provision that requires the
counterparty to deliver on at least a quarterly basis a report documenting the
calculation of Net Sales (including all components of information required to
calculate Net Sales) payable to Buyer pursuant to such agreement and (c) make
commercially reasonable efforts to enforce such provisions in such agreements.
7. Survival; Indemnification.
7.1 Survival. Except for the obligations of Seller pursuant to Section
7.2(a)(iv), the agreements, representations and warranties of the parties hereto
contained in this Agreement or the Transaction Documents or in any certificate
or other writing delivered pursuant hereto or thereto or in connection herewith
or therewith shall survive the Closing until the second anniversary of the
Closing Date. The obligations of Seller pursuant to Section 7.2(a)(iv) and
Section 7.2(a)(v) and liability for breach of the representations and warranties
in Section 4.2 shall survive indefinitely.
7.2 Indemnification.
(a) Seller hereby indemnifies Buyer, its officers, directors, agents,
and its Affiliates against and agrees to hold it harmless from any and all
damages, losses, liabilities and expenses (including without limitation
reasonable expenses of investigation and reasonable attorneys' fees and
expenses in connection with any claim, action, suit or proceeding) incurred
or suffered by Buyer arising out of:
(i) any misrepresentation or breach of warranty made by Seller
pursuant to this Agreement;
(ii) any breach of any covenant or agreement made by Seller pursuant
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to this Agreement or any Transaction Document;
(iii) any claims initiated by any employee, stockholder or creditor of
Seller as a result of this Agreement or the transactions contemplated
herein, except to the extent that the damages, losses, liabilities and
expenses result from a breach by Buyer of any of its representations,
warranties, covenants or other obligations hereunder;
(iv) any third-party claims related solely to the Excluded
Liabilities; or
(v) any product liability or similar third-party claims related to the
sale, marketing or use of a Product prior to the Closing Date.
(b) Buyer hereby indemnifies Seller, its officers, directors, agents,
and its Affiliates against and agrees to hold it harmless from any and all
damages, losses, liabilities and expenses (including without limitation
reasonable expenses of investigation and reasonable attorneys' fees and
expenses in connection with any claim, action, suit or proceeding) incurred
or suffered by Seller arising out of:
(i) any misrepresentation or breach of warranty made by Buyer pursuant
to this Agreement; or
(ii) any breach of any covenant or agreement made by Buyer pursuant to
this Agreement or any Transaction Document.
Other than in respect of indemnification claims under Sections 7.2(a)(iv) or
(v), in no event shall either party be entitled to recover an aggregate amount
exceeding $5,000,000 pursuant to this Section 7.2.
7.3 Procedures For Third Party Claims. Any Party seeking indemnification
under this Section 7 (the "INDEMNIFIED PARTY") shall give prompt notice to the
Party against whom indemnity is sought (the "INDEMNIFYING PARTY") of the
assertion of any third party claim; provided, however, that no delay on the part
of the Indemnified Party in notifying the Indemnifying Party shall relieve the
Indemnifying Party of any liability or obligation hereunder, except to the
extent that the Indemnifying Party has been prejudiced thereby. The Indemnifying
Party may, and at the request of the Indemnified Party shall, participate in and
control the defense of any third party claim at its own expense. If the
Indemnifying Party assumes control of the defense of any third party claim, the
Indemnifying Party shall not be liable under this Section 7 for any settlement
effected by the Indemnified Party without its consent of any third party claim.
Notwithstanding the foregoing, whether or not the Indemnifying Party assumes the
defense of a third party claim, if the Indemnified Party determines in good
faith that a third party claim is likely to materially adversely affect it or
its business (it being understood that any third party claim related to taxes or
the Intellectual Property shall be deemed to have a material adverse effect on
the Indemnified Party and its business) in a manner that may not be adequately
compensated by money damages, then the
-22-
Indemnified Party may, by written notice to the Indemnifying Party, assume the
exclusive right to defend, compromise, or settle such third party claim;
provided that in such case the Indemnifying Party will not be liable for any
money damages related to a settlement that is effected without its consent. The
party controlling the defense of any third party suit, action or proceeding
shall keep the other party advised of the status of such action, suit or
proceeding and the defense thereof and shall consider in good faith
recommendations made by the other party with respect thereto.
7.4 Equitable Relief; Exclusivity. Nothing contained herein shall preclude
Buyer or Seller from seeking injunctive or other equitable relief under
circumstances where such relief might be appropriate. Section 7.2 shall be the
exclusive remedy available to the parties hereto for money damages for any and
all claims subject to Section 7.2.
7.5 Limitations.
(a) The exclusive means for recovering any indemnification amounts
owing to Buyer pursuant to Section 7.2 shall be a set-off against amounts
owing to Seller pursuant to Section 2.4(b), Section 2.5 and Section 2.6,
the aggregate amount of which (except for indemnification claims under
Sections 7.2(a)(iv) or (v)) shall not exceed $5,000,000. Other than as
expressly provided in this Section 7.5, Buyer shall have no other recourse
to the assets of Seller for amounts owing pursuant to Section 7.2.
(b) An Indemnified Party shall not be permitted to enforce any claim
under Section 7.2 until the aggregate of all such claims of such
indemnified party exceeds US$50,000 (the "THRESHOLD AMOUNT"), and then only
to the extent that the claims in the aggregate exceed the Threshold Amount.
(c) Buyer shall not be entitled to indemnification under Section 7.2
for any misrepresentation or breach of warranty made by Seller in this
Agreement if, at the time of execution or delivery of this Agreement or at
Closing, a director or officer of Buyer had actual (and not constructive or
imputed) knowledge of the specific information that caused the
representation or warranty to be false or inaccurate. Seller shall not be
entitled to indemnification under Section 7.2 for any misrepresentation or
breach of warranty made by Buyer in this Agreement if, at the time of
execution or delivery of this Agreement or at Closing, a director or
officer of Seller had actual (and not constructive or imputed) knowledge of
the specific information that caused the representation or warranty to be
false or inaccurate.
8. Termination.
8.1 Grounds for Termination. This Agreement may be terminated:
(a) By the written agreement of both Buyer and Seller; or
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(b) By Seller if the Closing shall not have been consummated by
DECEMBER 15, 2005 (subject to any extension pursuant to Section 3.2(b)(ix)
hereof.
8.2 Effect of Termination.
If this Agreement is terminated for any reason pursuant to Section 8.1,
Seller shall not be required to refund the Purchase Price paid pursuant to
Section 2.4(a)(i), and the provisions of Sections 2.3 (Excluded
Liabilities), 9 (Miscellaneous) and 10 (Confidentiality) shall survive
termination of this Agreement.
9. Miscellaneous.
9.1 Expenses.
(a) Each of Seller and Buyer shall assume and bear all expenses, costs
and fees incurred or assumed by such party in the preparation and execution
of the Transaction Documents and the performance of the transactions
contemplated thereby, whether or not the transactions shall be consummated;
and Buyer and Seller shall indemnify and hold each other harmless from and
against any and all liabilities and claims in respect of any such expenses,
costs or fees not the responsibility of or assumed by the other party.
(b) Buyer will pay all (i) sales, use, value added and transfer taxes
and costs applicable to such transfer, and (ii) all costs of obtaining or
transferring any permits, registrations, applications and other tangible
and intangible properties, in each case whether incurred prior to, at or
subsequent to the Closing, in effecting the sale and transfer of the
Acquired Assets to Buyer as contemplated by this Agreement; provided,
however, that Buyer may offset against amounts payable to Seller pursuant
to Section 2.5(a) any amounts so paid solely in connection with the closing
of the transaction.
(c) Buyer shall be responsible for all transfer, freight,
transportation, shipment, risk of loss, insurance and the like with respect
to any and all materials purchased hereunder. Buyer shall promptly accept
and take delivery of such material at Seller's location(s).
9.2 Publicity; Disclosures; Confidential Information. No press release or
other public disclosure, either written, electronic or oral, of the transactions
contemplated hereby shall be made by Seller, Buyer or any of their respective
Affiliates or representatives without the express prior written consent of the
other party.
-24-
9.3 Notices. All notices, requests, demands, consents and communications
necessary or required under this Agreement shall be delivered by hand or sent by
registered or certified mail, return receipt requested, or by overnight courier,
or by facsimile (receipt confirmed) to:
if to Buyer: Valera Pharmaceuticals, Inc.
0 Xxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: President
Facsimile (000) 000-0000
with a copy to: Xxxxxx Xxxxxxxx LLP
000 Xxxxxx Xxxx
000 Xxxxxxx Xxxx
Xxxxxx, Xxxxxxxxxxxx 00000
Attn: Xxxxxxx X. Xxxxxx, Esq.
Facsimile: (000) 000-0000
if to Seller: Anthra Pharmaceuticals, Inc.
c/o Xxxxxx Xxxxxxxxx
Xxxx Capital Partners
000 X. 00xx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Facsimile No.: (000) 000-0000
With a copy to: Xxxxxx Xxxxxxxxxx, M.D.
Xxxx Capital Partners
000 X. 00xx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Facsimile No.: (000) 000-0000
with a copy to: Xxxxx Xxxxxxx Berlack Israels LLP
Xxxxx Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxx X. Xxxxxxx, Esq.
Facsimile No.: (000) 000-0000
with a copy to: Xxxxxxx X. Price
Xxxxxx LLP
000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Facsimile No.: (000) 000-0000
All such notices, requests, demands, consents and other communications
shall be deemed to have been duly given or sent 5 days following the date on
which mailed, or 2
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days following the date mailed if sent by overnight courier, or on the date on
which delivered by hand or by facsimile transmission (receipt confirmed), as the
case may be, and addressed as aforesaid.
9.4 Successors and Assigns. All covenants and agreements set forth in this
Agreement and made by or on behalf of any of the parties hereto shall bind and
inure to the benefit of the successors, heirs and assigns of such party, whether
or not so expressed. None of the parties may assign or transfer any of their
respective rights or obligations under this Agreement without the consent in
writing of the other parties hereto, which consent shall not be unreasonably
withheld or delayed; provided, however that (a) Seller may assign its rights to
receive payments under this Agreement and make any assignments incident to
dissolution of Seller without the consent of Buyer, and (b) without the consent
of Seller, any or all of the rights and interests of Buyer under this Agreement
may be assigned (i) to any purchaser of substantially all of the assets of
Buyer, (ii) to the surviving entity in any merger or consolidation involving
Buyer and (iii) as collateral security to any lender or lenders (including any
agent for any such lender or lenders) providing financing in connection with the
transactions contemplated by this Agreement, or to any assignee or assignees of
such lender, lenders or agent.
9.5 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original and all of which together shall constitute one
and the same instrument.
9.6 Severability. In the event that any one or more of the provisions
contained herein is held invalid, illegal or unenforceable in any respect for
any reason in any jurisdiction, the validity, legality and enforceability of any
such provision in every other respect and of the remaining provisions hereof
shall not be in any way impaired or affected, it being intended that each of
parties' rights and privileges shall be enforceable to the fullest extent
permitted by law, and any such invalidity, illegality and unenforceability in
any jurisdiction shall not invalidate or render unenforceable such provision in
any other jurisdiction.
9.7 Third Parties. Except as specifically set forth or referred to herein,
nothing herein expressed or implied is intended or shall be construed to confer
upon or give to any person or entity other than the parties hereto and their
permitted successors or assigns, any rights or remedies under or by reason of
this Agreement or any other certificate, document, instrument or agreement
executed in connection herewith.
9.8 Governing Law. This Agreement, including the validity hereof and the
rights and obligations of the parties hereunder, shall be construed in
accordance with and governed by the laws of the State of New York (without
giving effect to the conflicts of laws provisions thereof). Each of the parties
hereto agrees that any action or proceeding brought to enforce the rights or
obligations of any party hereto under this Agreement will be commenced and
maintained in any court of competent jurisdiction located in the State of New
York. Each of the parties hereto further agrees that process may be served upon
it by certified mail, return receipt requested, addressed as more generally
provided in
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Section 9.3 hereof, and consents to the exercise of jurisdiction of the courts
of the State of New York over it and its properties with respect to any action,
suit or proceeding arising out of or in connection with this Agreement or the
transactions contemplated hereby or the enforcement of any rights under this
Agreement.
9.9 Entire Agreement. This Agreement, including the Schedules and Exhibits,
is complete, and all promises, representations, understandings, warranties and
agreements with reference to the subject matter hereof, and all inducements to
the making of this Agreement relied upon by all the parties hereto, have been
expressed herein or in such Schedules or Exhibits or the Exclusivity Agreement.
This Agreement may not be amended except by an instrument in writing signed by
Seller and Buyer.
10. Confidentiality.
10.1 Definition of Confidential Information.
"CONFIDENTIAL INFORMATION" means, inter alia, any legal, commercial,
financial or other information, accounts, financial statements, reports, minutes
of meetings, correspondence, business or research strategies, technical data, or
know-how, regarding the Product and more generally any information regarding
Seller, Buyer or this Agreement or the transactions contemplated hereby provided
in any form.
"CONFIDENTIAL INFORMATION" does not include information which (a) is
already in the receiving party's possession and not subject to any other
confidentiality agreements, (b) becomes generally available to the public other
than as a result of disclosure by the receiving party, its directors, officers,
affiliates, investors, employees, or advisors, or (c) becomes available to the
receiving party on a non-confidential basis, provided that the source of such
information is not known to the receiving party to be bound by a confidentiality
agreement with or other obligation of secrecy.
10.2 Nondisclosure of Confidential Information. The parties agree that they
shall not, nor shall their officers, directors, affiliates, employees or agents
(which, for purposes solely of this Section 10.2, shall be deemed to include
PRF):
(a) use any Confidential Information for any purpose except to carry
out the transactions contemplated by this Agreement;
(b) disclose any Confidential Information to third parties, except as
required by law or legal process.
Each Party shall take all reasonable measures to protect the secrecy of and
avoid disclosure of Confidential Information in order to prevent it from falling
into the public domain or the possession of persons other than those persons
authorized under this Agreement to have any such Confidential Information.
Notwithstanding anything herein to the contrary, except as reasonably necessary
to comply with applicable securities laws, each party to this Agreement (and
each employee, representative, or other agent of such
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party) may (i) consult any tax advisor regarding the U.S. federal income tax
treatment or tax structure of the transaction, and (ii) disclose to any and all
persons, without limitation of any kind, the U.S. federal income tax treatment
and tax structure of the transaction and all materials of any kind (including
opinions or other tax analyses) that are provided to the taxpayer related to
such tax treatment and tax structure. For this purpose, "tax structure" is
limited to any facts relevant to the U.S. federal income tax treatment of the
transaction and does not include information relating to the identity of the
parties.
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IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as
of the date first set forth above.
SELLER:
ANTHRA PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxxxxx
------------------------------------
Xxxxxx Xxxxxxxxx
Director and Authorized Signatory
BUYER:
VALERA PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxxxx
------------------------------------
Xxxxx X. Xxxxxxx, President
