This Asset
Purchase Agreement (this “Agreement”) is made and
entered into as of July 20, 2004, by and between Cornerstone
Pharmaceuticals Ltd., an Anguilla company with offices located at
8000 Regency parkway, Suite 430, Cary, North Carolina 27511
(“Cornerstone”) and Vintage Pharmaceuticals, LLC, a
Delaware limited liability company with offices located at 130
Vintage Drive, Huntsville, Alabama 35811
(“Vintage”).
Vintage has
received FDA approval for two (2) products, one containing
Propoxyphene Napsylate/Acetaminophen 100/325mg Tab, ANDA #76-743,
and one containing Propoxyphene Napsylate/Acetaminophen 100/500mg
Tab ANDA #76-750 (the “Product(s)” as defined
below).
Subject to the
terms and conditions of this Agreement, Vintage desires to sell to
Cornerstone, and Cornerstone desires to purchase from Vintage, the
Purchased Assets (as defined below).
Now, therefore, in
consideration of the premises and the mutual covenants and promises
contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which hereby are acknowledged, the
parties agree as follows:
Section 1.01 Defined Terms.
As used in this
Agreement, the following defined terms have the meanings described
below:
“Cornerstone’s
Transfer Letter to the FDA” means the letter attached hereto
as Exhibit A-l and incorporated herein by reference notifying
the FDA of the change in ownership of the Product(s) ANDA(S), which
shall be sent to the FDA upon Cornerstone’s payment in full
of the Deferred Purchase Price (as defined below).
“Action or
Proceeding” means any action, suit, proceeding, arbitration,
inquiry, hearing, assessment with respect to fines or penalties, or
litigation (whether civil, criminal, administrative, investigative
or informal) commenced, brought, conducted or heard by or before,
or otherwise involving, any Governmental or Regulatory
Authority.
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
“Affiliate”
means, with respect to any Person, another Person that directly, or
indirectly through one or more intermediaries, controls, is
controlled by or is under common control with such Person.
“Control” and, with correlative meanings, the terms
“controlled by” and “under common control
with,” means the power to direct or cause the direction of
the management or policies of a Person, whether through the
ownership of voting securities, by contract, resolution, regulation
or otherwise.
“ANDA(S)”
means Abbreviated New Drug Application for the Products.
“Bill of
Sale and Assignment” means a Bill of Sale and Assignment in
the form attached hereto as Exhibit B.
“Books and
Records” means all files, documents, papers, and records in
the possession of Vintage and/or Cornerstone pertaining to the
Product(s), the Product(s) Intellectual Property and/or the
Marketing Materials.
“Calendar
Quarter” means the three month periods beginning on each
January 1, April 1, July 1 and October 1.
“Contract”
means any and all legally binding commitments, contracts, leases,
indentures, purchase orders, leases, or other agreements, whether
written or oral, including all amendments thereto.
“DEA”
means the United States Drug Enforcement Agency, and any successor
agency or entity thereto that may be established
hereafter.
“Encumbrance”
means any mortgage, pledge, security interest, deed of trust,
lease, lien, Liability, adverse claim, levy, charge, easement,
right of way, covenant, restriction, or other encumbrance,
third-party right or retained right of any kind whatsoever, or any
conditional sale agreement.
“FDA”
means the United States Food and Drug Administration.
“Governmental
or Regulatory Authority” means any court, tribunal,
arbitrator, authority, agency, commission, official or other
instrumentality of the United States or any state, county, city or
other political subdivision thereof.
“Know-How”
means all Product(s) specifications; manufacturing, physical
chemistry and formulation know-how; analytical testing methods and
validations; technical knowledge; practices and procedures;
formulae; confidential information; analytical methodology;
processes; methods; preclinical, clinical, stability and other data
and results; market studies; and all other experience and know-how,
in each case in tangible form, whether or not patentable, with
respect to the Product(s).
2
“Law”
means any federal, state or local law, statute or ordinance or any
rule, regulation, or published guidelines promulgated by any
Governmental or Regulatory Authority, including all regulations and
guidances of the FDA or the DEA.
“Liability”
means any obligations, debts or liability (whether known or
unknown, asserted or unasserted, absolute or contingent, accrued or
unaccrued, liquidated or unliquidated, matured or unmatured,
determinable or undeterminable, and due or to become
due).
“Manufacturing
Agreement” means the Manufacturing Agreement attached hereto
as Exhibit C between the Parties containing terms mutually
acceptable to both Parties involving the exclusive right of Vintage
to manufacture and supply the Product(s) to Cornerstone for a five
(5) year period.
“Marketing
Materials” means all marketing and promotional materials
useable with respect to the marketing and sale of the Product(s) to
the extent such materials are within the possession of
Vintage.
“Net Sales
of the Product(s)” means the gross amount invoiced by
Cornerstone or its Affiliates for sales of the Product(s) to third
persons (not including an Affiliate of Cornerstone), less (i)
trade, quantity and/or cash discounts actually allowed;
(ii) discounts, refunds, rebates, chargebacks, retroactive
price adjustments and any other allowances, credits or payments
which effectively reduce the net selling price; (iii) accruals
for Product(s) returns and allowances, up to an annual maximum of
[***] percent ([***]%); and (iv) the Product Price, as defined
in the Manufacturing Agreement. Inter-company accruals will not be
considered in the calculation of “Net Sales.” With
respect to accruals for Product(s) returns and allowances, within
sixty (60) after the end of each calendar year, the parties
shall reconcile such actual Product returns and allowances with the
estimated accruals. In the event such accruals are greater than the
actual returns and allowances, Cornerstone shall pay such
additional Royalty Payments as may be due Vintage pursuant to
Section 3.03. All such amounts and calculations will be
determined from books and records maintained in accordance with
U.S. Generally Accepted Accounting Principles
(“GAAP”).
“Order”
means any writ, judgment, decree, injunction or similar order of
any Governmental or Regulatory Authority (in each such case whether
preliminary or final).
“Party”
means each of Cornerstone and Vintage and “Parties”
mean Cornerstone and Vintage collectively.
“Patents”
means all U.S. patents, patent applications, and statutory
invention registrations (including any provisional applications and
invention disclosures) with respect to the Product(s).
“Person”
means any natural person, corporation, general partnership, limited
partnership, limited liability company, joint venture,
proprietorship, other business organization, trust, association, or
other entity, or any Governmental or Regulatory
Authority.
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
3
“Product(s)”
means Propoxyphene Napsylate and APAP 100/325mg Tablets and
Propoxyphene Napsylate and APAP 100/500mg Tablets, and Product(s)
means either of them.
“Product(s)
Intellectual Property” means any and all of the following,
intellectual property rights owned or licensed by Vintage that are
used or useful in the manufacture, sale, use, promotion, marketing
and/or distribution of the Product(s): (i) Patents;
(ii) Know-How; (iii) copyrights in any copyrightable Marketing
Material; (iv) the Product(s) Trademarks; and (v) any
trade dress related to the Product(s).
“Purchased
Assets” means the following: (i) all rights, title and
interest in and to the Product(s), including all rights to the
promotion, marketing, sale, distribution and manufacturing thereof;
(ii) the Product(s) Intellectual Property, (iii) the
Marketing Materials; and (iv) the Books and Records. For
purposes of clarification, the Purchased Assets do not include
equipment.
“Trademarks”
means all United States trademarks, trade names, brand names,
logotypes, symbols, service marks, designs, and trade names related
to the Product(s).
“Vintage’s
Transfer Letter to the FDA” means the letter attached hereto
as Exhibit A-2 and incorporated herein by reference notifying
the FDA of the change in ownership of the Product(s) ANDA(S), which
shall be sent to the FDA upon Cornerstone’s payment in full
of the Deferred Purchase Price.
Section 1.02 Construction of Certain Terms and
Phrases.
Unless the context
of this Agreement otherwise requires, when used in this Agreement:
(a) words of any gender include each other gender; (b) the
terms “hereof,” “herein,”
“hereto,” “hereby” and derivative or
similar words refer to this entire Agreement; (c) the term
“including,” “include” or
“includes” shall be deemed to be followed by
“without limitation”; and (d) references to
currency means U.S. Dollars. Whenever this Agreement refers to a
number of days, such number shall refer to calendar days unless
business days are specified. This Agreement shall be deemed to be
drafted jointly by all the Parties and shall not be specifically
construed against any Party hereto based on any claim that such
Party or its counsel drafted this Agreement.
PURCHASE AND SALE OF PURCHASED
ASSETS
Section 2.01 Purchase and Sale of Purchased
Assets.
Subject to the
terms and conditions of this Agreement, at the Closing, Vintage
shall sell, transfer, convey, assign and deliver to Cornerstone,
free and clear from all Encumbrances (except with respect to
Vintage), and Cornerstone shall purchase, acquire and accept from
Vintage, all right, title and interest, as of the Closing, in and
to the Purchased Assets in existence as of the Closing
Date.
4
Section 3.01 Purchase Price.
Subject to the
provisions of 3.02 below, the purchase price payable by Cornerstone
to Vintage for the Purchased Assets shall be the total sum of Eight
Million Dollars ($8,000,000.00) (the “Purchase
Price”).
Section 3.02 Payment of Purchase Price.
Cornerstone shall
pay Vintage the Purchase Price as follows:
(i) Cornerstone
shall pay Vintage $5,000,000.00 (U.S.) at the Closing in
immediately available funds by wire transfer into a bank account
designated by Vintage (the “Closing Payment”), (ii)
$1,500,000.00 (U.S.) shall be payable by Cornerstone to Vintage on
or before January 15, 2005, and (iii) $1,500,000 (U.S.) shall
be payable by Cornerstone to Vintage on or before July 15,
2005 (subsections (ii) and (iii) collectively, the
“Deferred Purchase Price”), also payable in immediately
available funds by wire transfer into a bank account designated by
Vintage. At the Closing, Cornerstone shall execute and deliver to
Vintage an executed promissory note evidencing its obligation to
pay Vintage the Deferred Purchase Price, which promissory note
shall be substantially in the form and content attached hereto as
Exhibit D (the “Secured Promissory Note”). The
Secured Promissory Note shall be guaranteed by Cornerstone
Pharmaceuticals Holdings, Ltd. as provided in the Guaranty
Agreement attached hereto as Exhibit E. In addition,
Cornerstone’s obligations under the Secured Promissory Note
shall be secured by a first priority security lien on the Purchased
Assets in favor of Vintage.
Section 3.03 Royalty Payments.
(a) Cornerstone
shall accrue and owe a royalty to Vintage equal to [***] percent
([***]%) of Net Sales of Product(s) in each Calendar Quarter by
Cornerstone or its Affiliate[s] (collectively referred to as the
“ Royalty Payment ”).
(b) Cornerstone
shall pay to Vintage the Royalty Payment attributable to Net Sales
of Product(s) made during a Calendar Quarter within sixty
(60) days of the end of such Calendar Quarter. For purposes of
this Agreement, a Net Sale of Product(s) will be deemed to have
been made as of the recorded sale date according to GAAP. Within
sixty (60) days of the end of such Calendar Quarter,
Cornerstone shall provide Vintage with a written report detailing
the Net Sales of Product(s) made during the previous Calendar
Quarter (each, a “ Royalty Statement ”).
Cornerstone will pay Royalty Payments (i) in immediately
available funds by wire transfer into a bank account designated by
Vintage or (ii) by check no later than two (2) business
days prior to
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
5
the due date
for such Royalty Payment. In the event that the actual Net Sale of
Product(s) cannot be determined by the date a Royalty Payment is
due (for example because final rebate or chargeback numbers have
not been confirmed), Cornerstone shall in good faith estimate such
Net Sale, with any true up (either by credit or additional payment,
as applicable) based on the actual Net Sale amount being made in
the Royalty Payment immediately following such determination. The
quarterly report described above shall detail any such true up
described in the preceding sentence.
(a) Cornerstone
shall maintain appropriate books of account and records, in
accordance with GAAP, which shall include inventory records, and
shall make accurate entries concerning all transactions relevant to
this Agreement.
(b) Vintage
shall have the right for two (2) years after any Royalty
Payment (or, in the event of a dispute involving in any way those
books of account and records with respect to a Royalty Payment, for
two (2) years after the dispute is resolved), on reasonable
notice to Cornerstone, to inspect and examine Cornerstone’s
books of account and records and other documents (including,
without limitation, vouchers, records, purchase orders, sales
orders and re-orders) relating to the Net Sales of Products to the
extent necessary to verify the accuracy of the Royalty Payments
made under this Agreement.
(c) Cornerstone
shall keep the books of account and records referenced in
Section 3.03(a) available during the period of Vintage’s
inspection rights set forth in Section 3.03(b).
(d) If, upon
inspection of the books of account and records of Cornerstone,
Vintage discovers that it did not receive the correct Royalty
Payment, Vintage shall notify Cornerstone in writing of such
discovery. In the event Cornerstone disagrees with such discovery,
the Parties shall negotiate in good faith to resolve such dispute.
Within thirty (30) days of receipt of Vintage’s notice
or, in the case of dispute, within thirty (30) days of
resolution of such dispute, Cornerstone shall pay to Vintage the
difference between what was paid and what should have been paid. If
the difference of the underpayment exceeds five per cent (5%) of
the Royalty Payment owed, then Cornerstone shall bear
Vintage’s reasonable costs in connection with such
inspection, including all reasonable legal and auditors fees. If
Vintage’s inspection of the books of account and records
reveals that Cornerstone overpaid a Royalty Payment, Vintage shall
pay to Cornerstone such overpayment within thirty (30) days of
the discovery of such overpayment.
Section 3.05 Authorized Generic.
(a) The
parties agree Vintage (or one of its affiliates) has the exclusive
right to manufacture and market an authorized generic version of
the Product(s) from time to time after a competing product with
identical active ingredients and concentrations has been approved
by FDA and has been commercially offered and/or marketed by a
competing company. Vintage (or its affiliate) may market an
authorized generic sooner if mutually agreed upon in writing. If
and when Vintage manufactures and markets an authorized generic
version of the Product(s),
6
Vintage and
Cornerstone agree to divide the net profits derived from such
marketing efforts [***]% due Vintage and [***]% due Cornerstone
(the “ Profit Split ”). Net profits shall be
defined as the number of pieces invoiced (and shipped), multiplied
by the net dollar amount for which each piece was sold, which shall
equal gross dollars, from which shall be deducted: cash discounts,
contractual rebates, CMS rebates, returns, chargebacks, and the
Product Price (as defined in the Manufacturing
Agreement).
(b) Cornerstone
shall have the right for two (2) years after any payment from
the Profit Split resulting from the genericization of products (or,
in the event of a dispute involving in any way those books of
account and records with respect to a Profit Split, for two
(2) years after the dispute is resolved), on reasonable notice
to Vintage, to inspect and examine the appropriate Vintage
affiliate’s books of account and records and other documents
(including, without limitation, vouchers, records, purchase orders,
sales orders and re-orders) relating to the Net Profit Payments to
the extent necessary to verify the accuracy of the Profit Split
made under this Agreement.
Section 4.01 Time and Place.
The closing of the
transactions contemplated by this Agreement (the
“Closing”) shall take place on the third (3
rd ) business day after the satisfaction of the
conditions set forth in Section 4.02 hereof, (the
“Closing Date”) but no later than July 20,
2004.
Section 4.02 Conditions Precedent.
(a)
Conditions Precedent to Cornerstone’s Obligations. All
obligations of Cornerstone to close the transactions contemplated
under this Agreement are subject to the fulfillment or satisfaction
of each of the following conditions precedent:
(i)
Representations and Warranties True as of the Closing Date .
The representations and warranties of Vintage contained in this
Agreement, the Manufacturing Agreement and in any schedule,
certificate or document delivered by Vintage to Cornerstone
pursuant to the provisions hereof or thereof will have been true on
the date hereof and will be true on the Closing Date with the same
effect as though such representations and warranties were made as
of the Closing Date.
(ii) Compliance
with this Agreement . Vintage will have performed and complied
with all agreements and conditions required by this Agreement to be
performed or complied with by it prior to or by the Closing
Date.
(iii)
Manufacturing Agreement . The Parties will have entered into
the Manufacturing Agreement.
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
7
(b)
Conditions Precedent to Vintage’s Obligations . All
obligations of Vintage to close the transactions contemplated under
this Agreement are subject to the fulfillment or satisfaction of
each of the following conditions precedent:
(i)
Representations and Warranties True as of the Closing Date .
The representations and warranties of Cornerstone contained in this
Agreement, the Manufacturing Agreement, and in any schedule,
certificate or document delivered by Cornerstone to Vintage
pursuant to the provisions hereof will have been true on the date
hereof and will be true on the Closing Date with the same effect as
though such representations and warranties were made as of the
Closing Date.
(ii) Compliance
with this Agreement . Cornerstone will have performed and
complied with all agreements and conditions required by this
Agreement to be performed or complied with by it prior to or by the
Closing Date.
(iii)
Manufacturing Agreement . The Parties will have entered into
the Manufacturing Agreement.
Section 4.03 Closing Date.
Each Party hereby
agrees to use commercially reasonable efforts to consummate the
transactions contemplated herein as soon as practicable but in no
event later than July 15, 2004. Termination of this Agreement
shall not relieve the Parties of any obligation accruing prior to
such termination or any breach of any term of this Agreement prior
to such termination. The rights and obligations of the Parties
under Sections 7.05 and this 4.03 and Articles V, VI and VIII
of this Agreement shall survive the expiration or termination of
this Agreement.
Section 4.04 Deliveries at Closing.
(a)
Closing Deliveries by Vintage . At or as part of the
Closing, Vintage shall deliver or cause to be delivered to
Cornerstone:
(i) To the extent
not previously delivered to Cornerstone, physical possession (or
implement arrangements satisfactory to Cornerstone of transfer and
delivery of physical possession) of all tangible personal property
included in the Purchased Assets;
(ii) The
Manufacturing Agreement duly executed by an authorized
representative of Vintage;
(iii) a Bill of
Sale and Assignment duly executed by an authorized representative
of Vintage with respect to the Purchased Assets in existence as of
the Closing;
8
(iv) a certificate
executed by an officer of Vintage, certifying in such detail as
Cornerstone may reasonably request that the conditions specified in
Sections 4.02(b)(i) and (ii), above, have been fulfilled;
and
(v) such other
documents, instruments and certificates as Cornerstone and Vintage
may mutually agree upon.
(b)
Closing Deliveries by Cornerstone . At the Closing,
Cornerstone shall deliver or cause to be delivered to
Vintage:
(ii) the Secured
Promissory Note and Security Agreement, duly executed by an
authorized representative of Cornerstone;
(iii) the Guaranty
Agreement duly executed by an authorized representative of
Cornerstone Pharmaceutical Holdings, Ltd.;
(iv) the Loan
Documents (as defined in the Secured Promissory Note) duly executed
by an authorized representative of Cornerstone;
(v) the
Manufacturing Agreement duly executed by an authorized
representative of Cornerstone;
(vi) a certificate
executed by an officer of Cornerstone, certifying in such detail as
Vintage may reasonably request that the conditions specified in
Sections 4.02(a)(i) and (v), above, have been
fulfilled;
(vii) such UCC
filings as may be necessary for Vintage to hold a valid, first
priority security interest in and to the Purchased Assets as
collateral for Cornerstone’s obligation to pay the Deferred
Purchase Price; and
(viii) such other
documents, instruments and certificates as Cornerstone and Vintage
may mutually agree upon.
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF VINTAGE
Vintage represents
and warrants to Cornerstone, as follows:
Section 5.01 Organization.
Vintage is a
limited liability company duly organized, validly existing and in
good standing under the laws of the state of its organization and
has all requisite power and authority to own the Purchased Assets.
Vintage is duly qualified to conduct its business and is in good
standing in each jurisdiction where the nature of such business
requires such qualification, except
9
for any
jurisdiction where failure to so qualify would not have a material
adverse effect or materially impair or delay Vintage’s
ability to perform its obligations hereunder.
Section 5.02 Authority of Vintage.
Vintage has all
necessary power and authority to enter into this Agreement and to
carry out the transactions contemplated hereby. Vintage has taken
all action required by Law, its certificate of organization,
operating agreement or otherwise to be taken by it to authorize the
execution and delivery of this Agreement by Vintage and the
consummation of the transactions contemplated hereby. This
Agreement has been duly and validly executed and delivered by
Vintage and, when duly authorized, executed and delivered by
Cornerstone, will constitute a legal, valid and binding obligation
of Vintage enforceable against it in accordance with its terms
except as limited by applicable bankruptcy, insolvency,
reorganization, fraudulent conveyance, moratorium and other laws of
general application affecting enforcement of creditors’
rights generally.
Section 5.03 Consents and Approvals.
Except for
Vintage’s Transfer Letter to the FDA, no consents, waivers,
approvals, Orders or authorizations of, or registrations,
declarations or filings with, any Governmental or Regulatory
Authority, or by any customer, supplier or other third party, are
required by or with respect to Vintage in connection with the
execution and delivery of this Agreement by Vintage or the
performance of its obligations hereunder, except for such consents,
waivers, approvals, Orders or authorizations the failure to obtain
which, and such registrations, declarations or filings the failure
to make which, would not have a material adverse effect or
materially impair or delay Vintage’s ability to perform its
obligations hereunder.
Section 5.04 Non-Contravention.
The execution and
delivery by Vintage of this Agreement does not, and the performance
by it of its obligations under this Agreement and the consummation
of the transactions contemplated hereby will not: (a) conflict
with or result in a violation or breach of any of the terms,
conditions or provisions of the certificate of organization,
operating agreement, or other organizational documents of Vintage;
or (b) conflict with or result in a violation or breach of any
term or provision of any Law applicable to Vintage, the Product(s)
or the Purchased Assets.
Section 5.05 Material Contracts.
Except as set
forth on Schedule 5.05, Vintage is not a party to any
Contracts that relate to (i) the manufacture, marketing, sale
or distribution of the Product(s); (ii) the sale, licensing
out, or assignment of the Purchased Assets; or (iii) sales of
Product(s) to any Governmental or Regulatory Authority.
10
Section 5.06 Intellectual Property Rights.
Neither the
Product(s) Intellectual Property, the use of Product(s)
Intellectual Property nor the Product(s), infringe or
misappropriate the intellectual property rights of any third party,
and Vintage has not received any written notice from any Person of
any claims of infringement or misappropriation with respect
thereto. In addition, all Trademarks included in the Produces)
Intellectual Property, if any, are the subject of current
registrations. There are no third-party rights in Vintage’s
current registrations relating to the Product(s) Trademarks. There
is not any prior use, infringement, piracy or counterfeiting of
such Product(s) Trademarks, any superior rights by any third party
in such Product(s) Trademarks, or any adverse claims pertaining to
such Product(s) Trademarks.
There are no
Actions or Proceedings pending, threatened or reasonably
anticipated against Vintage that relate to (a) the Purchased
Assets; (b) this Agreement; (c) the transactions
contemplated by this Agreement; or (d) the Product(s). Vintage
is not subject to any Order that could reasonably be expected to
materially impair or delay the ability of Vintage to perform its
obligations hereunder.
Section 5.08 Compliance with Law.
Vintage has been
in compliance with all applicable Laws with respect to the
Product(s), and Vintage has not received any written notice
alleging any violation of such Laws with respect to the
Product(s).
Section 5.09 Purchased Assets.
Vintage is the
sole and exclusive legal, and equitable owner of the Purchased
Assets and has good and marketable title to the Purchased Assets
free and clear of any Encumbrances. Vintage has the legal right and
ability to transfer the Purchased Assets to Cornerstone, and, upon
the Closing, shall transfer to good and marketable title to the
Purchased Assets free and clear of any Encumbrances.
Section 5.10 Regulatory Matters.
The Product(s)
ANDA(S) contains no material error or omission. Vintage has made
available to Cornerstone complete and correct copies of the
Product(s) ANDA(S). Except as set forth in Schedule 5.10, Vintage
has not received or been subject to: (i) any FDA
Form 483s relating to the Product(s); (ii) any FDA
Notices of Adverse Findings relating to the Product(s); or
(iii) any warning letters or other written correspondence from
the FDA or any other Governmental or Regulatory Authority
concerning the Product(s). Furthermore, Vintage represents that its
manufacturing facilities used to manufacture the Product(s) will be
considered in substantial compliance with FDA GMP’s at time
of Closing. Vintage will manage and maintain the ANDA(S) up until
the transfer letter is sent to the FDA. Following the
actual
11
transfer of the
ANDA(S), Cornerstone and Vintage may agree to have the ANDA(S)
managed and maintained by Vintage at such terms and price as
mutually agreed to by the parties.
Vintage has not
retained any broker in connection with the transactions
contemplated hereunder.
Section 5.12 No Non-Competition Agreements or Preferential
Obligations.
The Purchased
Assets are not subject to any non-competition agreements with, or
other agreements granting preferential rights to purchase or
license the Purchased Assets to, any third Persons.
Section 5.13 Exclusive Representations and
Warranties.
EXCEPT AS
EXPRESSLY PROVIDED IN THIS AGREEMENT AND THE MANUFACTURING
AGREEMENT, VINTAGE MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND VINTAGE SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED
OR STATUTORY WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE AND
WARRANTY OF NON-INFRINGEMENT.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES OF
CORNERSTONE
Cornerstone
represents and warrants to Vintage as follows:
Section 6.01 Corporate Organization.
Cornerstone is a
corporation duly organized, validly existing and in good standing,
under the laws of the jurisdiction of its incorporation and has all
requisite power and authority to own its assets and carry on its
business as currently conducted by it. Cornerstone is duly
qualified to conduct its business and is in good standing in each
jurisdiction where the nature of the business conducted by it
requires such qualification, except where failure to so qualify
could not reasonably be expected, individually or in the aggregate,
to have a material adverse effect on or materially impair or delay
Cornerstone’s ability to perform its obligations
hereunder.
Section 6.02 Authority of Cornerstone.
Cornerstone has
all necessary power and authority to enter into this Agreement and
to carry out the transactions contemplated hereby. Cornerstone has
taken all action required by Law, its by-laws, or otherwise to be
taken by it to authorize the execution and delivery of this
Agreement by Cornerstone and the consummation of the transactions
contemplated hereby. This Agreement has been duly and validly
executed and delivered by Cornerstone and, when duly
12
authorized,
executed and delivered by Vintage, will constitute a legal, valid
and binding obligation of Cornerstone enforceable against it in
accordance with its terms except as limited by applicable
bankruptcy, insolvency, reorganization, fraudulent conveyance,
moratorium and other laws of general application affecting
enforcement of creditors’ rights generally.
Section 6.03 Consents and Approvals.
Except for
Cornerstone’s Transfer Letter to the FDA, no consents,
waivers, approvals, Orders or authorizations of, or registrations,
declarations or filings with, any Governmental or Regulatory
Authority are required by Cornerstone in connection with the
execution and delivery of this Agreement by Cornerstone or the
performance of its obligations hereunder.
Section 6.04 Non-Contravention.
The execution and
delivery by Cornerstone of this Agreement does not, and the
performance by it of its obligations under this Agreement and the
consummation of the transactions contemplated hereby will not:
(a) conflict with or result in a violation or breach of any of
the terms, conditions or provisions of the certificate of
organization, operating agreement or other organizational documents
of Cornerstone; (b) conflict with or result in a violation or
breach of any terra or provision of any Law applicable to
Cornerstone; or (c) conflict with or result in a breach or
default (or an event which, with notice or lapse of time or both,
would constitute a breach or default) under, or result in the
termination or cancellation of, or accelerate the performance
required by, or result in the creation or imposition of any
security interest, lien or any other Encumbrance upon any Contract
to which Cornerstone is a party or by which Cornerstone or any of
its assets is bound.
There are no
Actions or Proceedings pending or, to the knowledge of Cornerstone
threatened or reasonably anticipated against Cornerstone which if
adversely determined would delay the ability of Cornerstone to
perform its obligations hereunder.
Cornerstone has
not retained any broker in connection with the transactions
contemplated hereunder.
Section 6.07 Exclusive Representations and
Warranties.
EXCEPT AS
EXPRESSLY PROVIDED IN THIS AGREEMENT AND THE MANUFACTURING
AGREEMENT, CORNERSTONE MAKES NO REPRESENTATION OR WARRANTY, EXPRESS
OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND CORNERSTONE SPECIFICALLY DISCLAIMS ANY AND ALL
IMPLIED OR STATUTORY WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR. PURPOSE AND
WARRANTY OF NON-INFRINGEMENT.
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ARTICLE VII
COVENANTS OF THE PARTIES
Section 7.01 Cooperation.
Each Party shall
reasonably cooperate with the other in preparing and filing all
notices, applications, submissions, reports and other instruments
and documents that are necessary, proper or advisable under
applicable Laws to consummate and make effective the transactions
contemplated by this Agreement, including Vintage’s
reasonable cooperation in the efforts of Cornerstone to obtain any
consents and approvals of any Governmental or Regulatory Authority
required for Cornerstone to be able to sell the
Product(s).
Cornerstone and
Vintage waive compliance with all bulk sales Law applicable to the
transactions contemplated by this Agreement.
Section 7.03 Regulatory Matters.
From and after the
transfer by Vintage to Cornerstone of the Product(s) ANDA(S)
pursuant to the terms hereof, Cornerstone, at its cost, shall be
solely responsible for (i) taking all actions, paying all fees
(except to the extent such fee accrued prior to the Closing Date)
and conducting all communication with the appropriate Governmental
or Regulatory Authority in respect of the Product(s) ANDA(S) and
the Product(s), including preparing and filing all reports
(including adverse drug experience reports) with the appropriate
Governmental or Regulatory Authority; (ii) taking all actions and
conducting all communication with third parties in respect of
Product(s) sold pursuant to the Product(s) ANDA(S), including
responding to all complaints and medical inquiries in respect
thereof, including complaints related to tampering or
contamination; (iii) investigating all complaints and adverse drag
experiences in respect of Product(s) sold pursuant to the
Product(s) ANDA(S); and (iv) filing all annual reports, field
alerts, and any and all other reports as may be required from time
to time by the FDA. Without limiting the foregoing, prior to the
Closing Date, Vintage shall regularly consult with Cornerstone
about all regulatory matters and decisions related to the
Product(s) and the Product(s) ANDA(S).
Vintage will
manufacture the Product(s) according to the approved formulations
and specifications in accordance with the terms of the
Manufacturing Agreement. Any changes to the formulations and/or
specifications submitted and/or approved by FDA will be
communicated by Cornerstone to Vintage in writing. Furthermore,
Cornerstone will not request any supplemental changes to the
approved ANDAs without first cons
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