|
Exhibit
10.173
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE
BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE
COMMISSION
****** DENOTES CONFIDENTIAL TREATMENT
REQUESTED
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.
“BILL 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 208
Bath Road, Slough, Berkshire, SL1 3WI, UK 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.
“GOVERNMENTAL
BODY” means any federal, state, municipal or other
governmental department, commission, board, bureau, court, agency,
authority or instrumentality, domestic or foreign.
2
“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.
“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.
3
“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 Paul
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.
“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
56124-62-0.
4
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 Bill of Sale and Assignment (the
“BILL 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 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.
5
(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) [******] 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 which the eighth anniversary of the Closing occurs:
(A) [******] 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.
****** CONFIDENTIAL TREATMENT
REQUESTED
6
(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 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
****** CONFIDENTIAL TREATMENT
REQUESTED
7
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 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.
8
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 Pepper Hamilton LLP, counsel to
Buyer, 400 Berwyn Park, 899 Cassatt Road, Berwyn, Pennsylvania
19312 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”).
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 Seller shall
have received at the Closing a certificate from an appropriate
officer of Buyer to that effect.
9
(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 b
|