Exhibit 10.1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this “ Agreement
”) is entered into as of February 19, 2008, by and
between NOVAVAX, INC., a Delaware corporation (“
Seller ”), and GRACEWAY PHARMACEUTICALS, LLC, a
Delaware limited liability company (“ Buyer ”).
Seller and Buyer are sometimes referred to herein as the
“parties” and individually as a
“party”.
WHEREAS , Seller developed a pharmaceutical product known as
Estrasorb® (such product, including all dosages and
formulations, whether existing on the date hereof or in the past,
the “ Product ”), utilizing certain micellar
nanoparticle technology owned by Seller and covered in Patent
No. 5,629,021 (the “ MNP Technology
”);
WHEREAS , Seller granted to Allergan USA, Inc. (formerly
known as Esprit Pharma, Inc.), a Delaware corporation (“
Esprit ”), an exclusive license to certain rights to
manufacture, market, promote and sell the Product in the United
States, Mexico and Canada, and subsequently thereafter Seller
transferred to Esprit all right, title and interest in and to the
NDA (as hereinafter defined) for the Product and other regulatory
approvals for the Product;
WHEREAS , Allergan, Inc., a Delaware corporation (“
Allergan ”), owns, directly or indirectly, all of the
outstanding capital stock of Esprit;
WHEREAS , Seller, collectively with Esprit and certain of
Esprit’s affiliates, own all right, title and interest in, to
and under all assets, properties, privileges, claims and rights
relating to the Product and the MNP Technology in the Territory (as
hereinafter defined);
WHEREAS , concurrently with the execution and delivery of
this Agreement, Buyer, Esprit and Allergan have entered into an
Asset Purchase Agreement (the “ AGN Asset Purchase
Agreement ”), pursuant to which Esprit has agreed to sell
to Buyer, and Buyer has agreed to purchase from Esprit, all right,
title and interest of Esprit and certain of Esprit’s
affiliates in the Territory in and to the assets and rights
associated with the Product identified therein, and Allergan has
agreed to guaranty the obligations of Esprit thereunder, all on the
terms and subject to the conditions set forth in the AGN Asset
Purchase Agreement; and
WHEREAS , Seller desires to sell to Buyer, and Buyer desires
to purchase from Seller, all right, title and interest of Seller in
the Territory in and to the Product and the MNP Technology, and all
privileges, claims and rights relating to the Product, and the MNP
Technology and the other assets and rights identified herein, all
on the terms and subject to the conditions hereinafter set
forth.
NOW, THEREFORE , in consideration of the foregoing and of
the representations, warranties, mutual covenants and agreements
hereinafter set forth and intending to be legally bound hereby, the
parties hereto agree as follows:
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
ARTICLE 1.
DEFINITIONS AND INTERPRETATIONS
Capitalized
terms used herein without definition shall have the respective
meanings assigned thereto in Annex I attached hereto and
incorporated herein for all purposes of this Agreement (such
definitions to be equally applicable to both the singular and
plural forms of the terms defined). Additionally, in this
Agreement, unless a clear contrary intention appears: (a) all
references herein to “Articles” or
“Sections” are to Articles or Sections of this
Agreement; (b) the singular number includes the plural number
and vice versa ; (c) reference to any agreement,
document or instrument means such agreement, document or instrument
as amended or modified and in effect from time to time in
accordance with the terms thereof; (d) “including” (and
with correlative meaning “include”) means including
without limiting the generality of any description preceding such
term; and (e) references to documents, instruments or
agreements shall be deemed to refer as well to all addenda,
exhibits, schedules or amendments thereto.
ARTICLE 2.
SALE AND PURCHASE OF ASSETS;
PURCHASE PRICE; EXCLUDED LIABILITIES
2.01 Sale and Purchase of
Assets.
Subject
to the terms and conditions of this Agreement (including
Section 2.02 ), at Closing Seller shall sell, assign,
transfer, convey and deliver to Buyer, and Buyer shall purchase,
acquire, pay for and accept from Seller, all right, title and
interest of Seller and its Affiliates in the Territory in, to and
under the following assets, properties, privileges, claims and
rights (collectively, the “ Assets ”), free and
clear of all Encumbrances:
(a) The
Patents, Marks, Trademark Registrations and Copyrights described in
Schedule 2.01(a) , and all other Intellectual Property
(including Trade Secrets) relating primarily to the Product (all
such Assets described in the foregoing clauses, the “
Assigned Intellectual Property ”);
(b) All
Know-How that is (i) primarily related to the Product or the
Business, (ii) contained within or comprising the Books and
Records or (iii) used, useful or necessary in connection with
the manufacture, packaging, labeling or testing of the Product as
conducted by Seller or its Affiliates as of the date hereof, or in
connection with the use, maintenance or operation of the
Manufacturing Equipment by or on behalf of Seller or its Affiliates
as of the date hereof, in each case solely for the Territory
(except in connection with the exercise of Buyer’s rights in
Section 2.01(g) to make or have made the Product
outside the Territory) (all such Know-How described in clauses (i),
(ii) and (iii), the “ Transferred Know-How
”);
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
(c) All
registrations, applications, approvals, licenses and permits
relating to the Assets (including the Product) from the FDA and any
other Governmental Authority in the Territory held in the name of
Seller or any of Seller’s Affiliates (collectively, the
“ Product Registrations ”), including those set
forth on Schedule 2.01(c) , and all supplements
thereto, whether issued, pending, or in draft form, and all
records, reports, data and other information primarily related to
the Assets (including the Product) required to be kept under
applicable Laws in the Territory and all correspondence to or from
all Governmental Authorities in the Territory which relates
primarily to the Assets (including the Product);
(d) All
current and archived books, computer data, records, files,
documents, information, correspondence and data (audio, visual or
print) in Seller’s possession or control to the extent
relating primarily to the Assets (including the Product) for the
Territory, including in each case as and to the extent relating
primarily to the Assets for the Territory, as applicable: research
and development reports, studies, pre-clinical and clinical data,
research and development data, lists of customers and suppliers of
the Product in the Territory, miscellaneous records with respect to
customers and supply sources, credit and collection records,
adverse experience reports and files and data related thereto and
all periodic adverse experience reports, files and data, and all
other files, data and records related to pharmacovigilence matters,
business development plans, advertising matter, catalogs,
correspondence, mailing lists, photographs, sales and distribution
materials and records, purchasing materials and records,
manufacturing and quality control records and procedures, market
materials, marketing and promotional materials, product literature,
training materials, sale aids, research data, copies of all files
relating to the filing, prosecution, issuance, maintenance,
enforcement and/or defense of any Assigned Intellectual Property,
master batch records, including change of control history, executed
records for all lots, including those expired, product batch
records, analytical methods and validation reports with respect to
process, equipment and methods, product complaints, stability data
and the history thereof, annual reports, annual product reports,
FDA and internal audit reports, whether on paper or in electronic
format (the “ Books and Records ”);
(e) The
manufacturing equipment and assets listed on
Schedule 2.01(e) (the “ Manufacturing
Equipment ”), and any warranty rights applicable to such
Manufacturing Equipment (to the extent the same are
transferable);
(f) All
customer and supplier relationships and goodwill primarily related
to the Product;
(g) All
rights to market or have marketed, sell or have sold, promote or
have promoted, distribute or have distributed the Product in the
Territory, and make or have made the Product in or outside of the
Territory, including, to the extent transferable, all rights to
reference Drug Master Files and other data for the Product’s
active pharmaceutical ingredients;
(h) All
claims, counterclaims, credits, causes of action, rights of
recovery and rights of setoff and third party warranties,
guaranties and similar contractual rights
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
as to
the third parties held by Seller or any Affiliate of Seller to the
extent related primarily to the Assets; and
(i) All
other assets, properties, privileges, claims and rights of Seller
and its Affiliates relating primarily to the Product or the
Business in the Territory (except for Intellectual Property or
Know-How, each of which is being sold, assigned, transferred,
conveyed and delivered by Seller to Buyer pursuant to the other
subparagraphs of this Section 2.01 ).
2.02 Excluded Assets.
(a) Notwithstanding
anything to the contrary in this Agreement, there shall be excluded
from the Assets, and retained by Seller, the following assets
(collectively, the “ Excluded Assets ”):
(i)
all cash and cash equivalents owned by Seller;
(ii)
all contracts of insurance and all insurance plans and the assets
thereof;
(iii)
all accounts receivable or invoices arising out of the sale of the
Product on or prior to 11:59 p.m. (EST) on the Closing
Date (“ Pre-Closing Receivables ”);
(iv)
any and all claims of Seller with respect to any Tax refunds;
(v)
all human resources and any other employee related files and
records;
(vi)
subject to the license and rights granted to Buyer pursuant to
Section 6.04 , all right, title and interests of Seller
in and to the Names;
(vii)
all books and records relating to or used in the business of Seller
and not primarily relating to the Assets;
(viii)
all assets of the Seller not expressly included within the Assets
set forth in Section 2.01 above; and
(ix)
all of the rights of Seller under or pursuant to this Agreement or
any other rights in favor of Seller pursuant to the Related
Documents.
(b) Notwithstanding
the foregoing, neither Seller nor any of its Affiliates shall
retain any interest, royalty or Intellectual Property rights
relating to the Assets in the Territory, other than rights to
receive cash or cash equivalents in connection with Pre-Closing
Receivables, except as expressly set forth in the Related
Agreements.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
(c) For
the avoidance of doubt under Section 2.01(b) , Buyer
acknowledges that Seller retains the ownership rights in the
Know-How for use outside the Territory, including the right to
develop, make, have made, use, sell, offer for sale, and import
products solely outside the Territory, subject to Buyer’s
right in accordance with Section 2.01(g) to make or
have made the Product outside of the Territory. Buyer hereby agrees
not to assert any ownership right, title or interest in or to the
Know-How outside the Territory inconsistent with Buyer’s
rights under Section 2.01(b) and the foregoing
acknowledgement in this Section 2.02(c) .
2.03 Excluded
Liabilities.
Notwithstanding
anything to the contrary in this Agreement, Buyer shall not assume,
and Seller and its Affiliates shall retain, pay, perform and
discharge when due, all Liabilities of Seller and its Affiliates
arising out of or related to the Product and the Business prior to
the Closing Date (collectively, the “ Excluded
Liabilities ”), except for any post-Closing Date
liabilities expressly agreed to be assumed by Buyer pursuant to
this Agreement. The Excluded Liabilities shall include the
following:
(a) account
payables and Liabilities of Seller or any of its Affiliates for
materials and services with respect to the manufacture of the
Product or Inventory prior to the Closing Date;
(b) any
Tax payable with respect to any business, asset, property or
operation of Seller or any member of any affiliated group of which
Seller is a member (including any Taxes relating to or arising out
of the operation of the Business) arising out of, directly or
indirectly, the Assets or the ownership, control, lease, or license
of any of the Assets for any pre-Closing Tax period, other than any
Tax for which Buyer is responsible pursuant to
Section 10.03 ;
(c) any
Liability of Seller or any of its Affiliates arising out of or
relating to any Excluded Asset or arising out of the operations or
conduct by Seller or its Affiliates of any business other than the
Business;
(d) any
Liability of Seller or any of its Affiliates arising out of or
relating to independent contractors or employees, including any
Liability with respect to employment, compensation or benefits
(including severance and benefit plans) for the present or future
employees of Seller for all employment relating to the
Business;
(e) all
Liabilities of Seller and any of its Affiliates arising out of any
product liability, patent infringement, breach of warranty or claim
for injury to person or property whenever asserted which resulted
from the use or misuse of Product sold prior to the Closing Date
(including all proceedings relating to any such Liabilities);
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
(f) all
Liabilities of Seller and any of its Affiliates arising out of
government seizures, field corrections, withdrawals or recalls of
Product sold prior to the Closing Date, whether claimed prior to,
on or after the Closing Date;
(g) all
Liabilities of Seller and any of its Affiliates with respect to any
litigation or other claims to the extent arising from any event,
circumstance or condition occurring or alleged to have occurred
prior to the Closing Date;
(h) all
Liabilities of Seller and any of its Affiliates arising out of user
or other similar fees payable to the FDA or other Governmental
Authority in the Territory to the extent such fees are payable on
account of the operation of the Business prior to the Closing
Date;
(i) all
Liabilities of Seller and any of its Affiliates arising out of or
related to the use, maintenance, occupancy or possession of the
Catalent Facility or the Manufacturing Equipment prior to and
during the term of the Supply Agreement, and all Liabilities
arising out of or related to the cleaning and removal of such
Manufacturing Equipment from the Catalent Facility (except for
those costs and expenses of Seller to be reimbursed by Buyer
pursuant to the Supply Agreement), and the restoration of the
Catalent Facility to its prior condition; and
(j) all
other Liabilities of whatever kind and nature, primary or
secondary, direct or indirect, absolute or contingent, known or
unknown, whether or not accrued, arising out of or relating to,
directly or indirectly, the Seller’s operation of the
Business prior to the Closing Date or Seller’s ownership of
the Assets (including the Product) prior to the Closing Date.
2.04 Purchase Price.
For and
in consideration of the conveyances and assignments described
herein, Buyer agrees to pay to Seller, and Seller agrees to accept
from Buyer, an amount equal to [* * *] (the “ Purchase
Price ”).
2.05 Payment at
Closing.
The
Purchase Price shall be paid by Buyer to Seller at the Closing by
wire transfer of immediately available funds to the account
specified by Seller in writing prior to the Closing.
2.06 Additional
Assurances.
In
addition to and without limitation of the obligations of Seller set
forth in Section 10.02 , in the event that from and after
the Closing Date, Seller or Buyer shall become aware of any Asset
that was not transferred to Buyer on the Closing Date, then Seller
shall
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
promptly
assign, transfer and convey such Asset to Buyer, free and clear of
all Encumbrances, pursuant to assignment documentation reasonably
satisfactory to Buyer; provided , that nothing in this
Section 2.06 shall limit Seller’s right to contest
whether an item is an Asset that should have been conveyed to Buyer
at Closing.
ARTICLE 3.
REPRESENTATIONS AND WARRANTIES BY SELLER
Seller
represents and warrants to Buyer as follows as of the Closing
Date:
3.01 Organization and
Standing.
Seller
is duly organized, validly existing and in good standing under the
laws of the State of Delaware and is duly qualified to do business
and is in good standing in any jurisdiction where such
qualification is necessary. Seller has the corporate power and
authority to own, lease and otherwise to hold the Assets, to carry
on the Business, and to enter into and perform the terms of this
Agreement, the other Related Documents to which it is a party and
the transactions contemplated hereby and thereby.
3.02 Authorization.
The
execution, delivery and performance of this Agreement and of the
other Related Documents to which Seller is a party, and the
consummation of the transactions contemplated hereby and thereby,
have been duly and validly authorized by all necessary corporate
actions of Seller (none of which actions has been modified or
rescinded and all of which actions are in full force and effect).
This Agreement constitutes, and upon execution and delivery each
other Related Document to which Seller is a party will constitute,
a valid and binding agreement and obligation of Seller, enforceable
against Seller in accordance with their respective terms, except as
the same may be limited by bankruptcy, insolvency, reorganization,
moratorium and other similar laws of general applicability relating
to or affecting creditors’ rights generally and by the
application of general principles of equity.
3.03 Consents and Approvals; No
Conflicts.
(a) The
execution and delivery of this Agreement and each other Related
Document to which Seller is a party, and the performance of the
transactions contemplated herein and therein by Seller will not
require any consent, approval, authorization or other action by,
or, except as set forth on Schedule 3.03 , filing with
or notification to, any Governmental Authority or other
Person.
(b) The
execution, delivery and performance by Seller of this Agreement and
the other Related Documents to which Seller is a party do not and
will not (i) conflict with or violate any Law applicable to
Seller, the Assets or the Business or by which any
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
of the
Assets or the Business is subject or affected, (ii) conflict
with or result in any breach of or constitute a default (or an
event which with notice or lapse of time or both would become a
default) under any Contract to which Seller is a party or by which
Seller is bound or to which any of the Assets or the Business is
subject or affected, (iii) result in the creation of any
Encumbrance upon the Assets, or (iv) conflict with or violate the
organizational documents of Seller; except in the case of clause
(i) or (ii) where such conflict, violation or breach would not
be reasonably be expected to have a material adverse effect on the
Assets or the Business.
3.04 Absence of Certain Changes
or Events.
Since
September 1, 2007, there has been no Material Adverse Change
in the Business or the Assets (including the Product). Except as
set forth in Schedule 3.04 , since September 1,
2007, Seller has conducted the Business in the ordinary course of
business consistent with past practice, and Seller has not
(a) incurred, or become subject to, any Liability with respect
to the Assets, except current Liabilities incurred in the ordinary
course of business consistent with past practice;
(b) mortgaged, pledged or subjected to any Encumbrance any of
the Assets; (c) transferred to any third party any rights
under any licenses, sublicenses or other agreements with respect to
any Assigned Intellectual Property; (d) sold, exchanged,
transferred or otherwise disposed of, or granted any rights or
options in or to, any of the Assets, except for the transfer of
inventory in the ordinary course of business; or (e) entered
into any transactions with respect to the Business other than in
the ordinary course of business consistent with past
practice.
3.05 Absence of
Litigation.
Except
as set forth on Schedule 3.04 , there is no action,
suit, investigation, proceeding, claim, arbitration or litigation
pending against the Seller or its Affiliates or, to the knowledge
of Seller, threatened against Seller or its Affiliates with respect
to the Product.
3.06 Assets.
Except
for the Excluded Assets, (a) the Assets described in
subsections (a) through (l) of Section 2.01
constitute all of the assets, rights and properties of Seller that
are sufficient for the operation of the Business by Seller, and
(b) to the Seller’s knowledge, the Assets, together with
the assets and rights previously sold or licensed by Seller to
Esprit, constitute all assets, rights, privileges and claims
relating to the Product and the MNP Technology in the Territory.
The sale, transfer and assignment of the Assets as contemplated by
this Agreement will give Buyer possession of all assets, rights and
properties of Seller, taken as a whole, required to operate the
Business by Seller. Except as set forth on Schedule 3.06 ,
Seller is the sole owner of, and has good and valid title to, the
Assets free and clear of any Encumbrances. No Asset is subject to
any preemptive right, right of first refusal or other right or
restriction arising by or through Seller or any of its Affiliates.
At the Closing, Buyer shall acquire good title to, and all right,
title and interest in and to the Assets, free and clear of all
Encumbrances,
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
except
for (and specifically excluding) any Encumbrances arising through,
at the direction of, or relating to Buyer or its Affiliates.
3.07 Contracts; Product
Registrations.
Except
as set forth on Schedule 3.07 , neither Seller nor any
of its Affiliates is a party to or bound by any material Contract
primarily relating to the Business or the Assets. Except as set
forth on Schedule 2.01(a) or
Schedule 2.01(c) , neither Seller nor any of its
Affiliates (a) owns or holds any right, title or interest in
any registrations, applications, approvals, licenses or permits
relating primarily to the Assets (including the Product) from the
FDA or any other Governmental Authority in the Territory, or
(b) has in the past owned or held any Product Registrations
from any Governmental Authority in the Territory, or registered any
Intellectual Property with any Governmental Authority in the
Territory.
3.08 Intellectual
Property.
(a)
Schedule 2.01(a) contains a complete and accurate
listing of the following, listing the status or renewal dates for
each: (i) all registered Assigned Intellectual Property,
including the registered Marks, Trademark Registrations, Patents
and Copyrights; and (ii) all oral and written material
Contracts relating to the Assigned Intellectual Property to which
Seller is a party or by which Seller is bound. Except as set forth
on Schedule 3.08 , Seller has not granted any license
of any kind relating to the Assigned Intellectual Property.
(b) Except
as set forth in Schedule 3.08 , Seller is the sole and
exclusive owner of, and has good, valid, and enforceable title to,
all rights, title, and interest in and to each item of the Assigned
Intellectual Property, free and clear of any Encumbrances. Except
as set forth in Schedule 3.08 , Seller has the right to
make any use desired, without payment to a third party, of all or
any part of the Assigned Intellectual Property and the right to
convey such Assigned Intellectual Property to Buyer. At the Closing
Date, Buyer shall acquire good, valid, and enforceable title to the
Assigned Intellectual Property, free and clear of all
Encumbrances.
(c) Except
as set forth in Schedule 3.08 , to the knowledge of
Seller: (i) the use by Seller of the Transferred Know -
How in connection with the Business does not infringe,
misappropriate, or violate, with any Intellectual Property right or
other proprietary right of any other Person or requires a license
under the same; (ii) the Assigned Intellectual Property does
not infringe, misappropriate, violate, or conflict with any
Intellectual Property right or other proprietary right of any other
Person or require a license under the same; (iii) Seller has
terminated all licenses, sublicenses or other grant of rights
granted or provided by Seller with respect to the Product or the
Assigned Intellectual Property to any third party (including the
Esprit License Agreement), and there exist no further Liabilities
under any such license or sublicense; (iv) Seller is not in
breach or default of any license or other grant of rights with
respect to the Assigned Intellectual Property, nor is any other
Person in breach or default of any such license or grant of rights;
(v) there have been no claims made against, or notices
received
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
by
Seller or any of its Affiliates alleging or asserting the
invalidity, misuse or unenforceability of any Assigned Intellectual
Property (including any demand or request that Seller cease using
any Assigned Intellectual Property or license any Intellectual
Property from any third party); and (vi) neither Seller nor any of
its Affiliates have taken any action, or failed to take any action,
used or enforced or failed to use or enforce any of the Assigned
Intellectual Property in a manner that would result in the
abandonment, cancellation, forfeiture, relinquishment, or
unenforceability of any of the Assigned Intellectual Property, or
any registration therefor, or any of Seller’s rights
therein.
(d) Any
Assigned Intellectual Property that has been duly registered with
or filed in the U.S. Patent and Trademark Office or the U.S.
Copyright Office or other applicable Governmental Authority is
identified on Schedule 2.01(a) , and all such
registrations are currently in compliance with all formal legal
requirements; provided , however , that Copyrights
have not been registered with the U.S. Copyright Office or
otherwise been registered with any Governmental Authority. To
Seller’s knowledge, Seller has taken all commercially
reasonable and desirable actions consistent with its past practice
to maintain and protect the Assigned Intellectual Property owned by
Seller and no loss or expiration of any such Assigned Intellectual
Property is pending or threatened.
3.09 Compliance with
Law.
(a) All
of Seller’s manufacture, packaging, labeling, testing for
release and sale of Product has been in compliance with all
applicable requirements under FDCA, PHSA, and similar Laws, rules
and regulations relating to investigational use, premarket
clearance, licensure, or application approval, good manufacturing
practices, record keeping, filing of reports, including adverse
event reports as required by 21 C.F.R. Section 314.80.
(b) Seller
has obtained all applicable material approvals, clearances,
authorizations, licenses and registrations required by the United
States, any other Governmental Authority, or foreign governments or
government agencies, to permit the operation of the Business, and
Seller is in material compliance with all reporting requirements
relevant thereto.
(c) To
Seller’s knowledge, the NDA held by Allergan for the Product
is in full force and effect.
(d) With
respect to the Product, neither Seller nor any of its Affiliates is
in violation of and Seller and its Affiliates are in compliance
with, all applicable registration and listing requirements set
forth in 21 U.S.C. § 360 and 21 C.F.R. Part 207, in each
case as applicable to Seller’s conduct of the Business.
(e) All
manufacturing, warehousing, distributing, and testing operations
conducted by Seller or any of its Affiliates or, to the
Seller’s knowledge, for the benefit of Seller or any of its
Affiliates with respect to the Product in the Territory are not in
violation of and have
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
been and
are being conducted in material compliance with, the good
manufacturing practice regulations set forth in 21 C.F.R. Parts 210
and 211.
(f) With
respect to the Product in the Territory, neither Seller, any of its
Affiliates or their respective officers, employees, or agents has
made an untrue statement of material fact or fraudulent statement
to the FDA or any other Governmental Authority, failed to disclose
a material fact required to be disclosed to the FDA or any other
Governmental Authority, or committed an act, made a statement, or
failed to make a statement that could reasonably be expected to
provide a basis for the FDA to invoke its policy respecting
“Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities”, set forth in Compliance Policy Guide
sec. 120.100 (7150.09) (issued September 1, 1991) and any
amendments thereto.
(g) With
respect to the Product in the Territory or to the facilities in
which the Product has been developed, manufactured, packaged,
collected, handled or stored by or on behalf of Seller, no written
reports of inspection observations (FDA Form 483),
establishment inspection reports, warning letters or other
documents have been received by Seller from by the FDA or other
regulating agencies within the last three (3) years that
allege lack of compliance with applicable regulatory requirements
by Seller, its Affiliates, or, to the knowledge of Seller, Persons
covered by product applications or otherwise performing services
for the benefit of Seller or its Affiliates.
(h) Seller
has made available to Buyer copies of all written communications to
the FDA from Seller or received by Seller from the FDA relating
specifically to the Product in the Territory, and Seller’s
operations or business, including any deficiency letter, warning
letter, non-approvable letter/order, withdrawal letter/order and
correspondence bearing on the safety and efficacy of the
Product.
(i) Neither
Seller nor any of its Affiliates have received any written notice
and have no knowledge that the FDA, or any other regulating agency,
has commenced or threatened to initiate, any action seeking the
withdrawal, recall, suspension, or seizure of the Product in the
Territory, or commenced or threatened to initiate, any action to
enjoin production at any facility where the Product has been
manufactured.
(j) As
to each article of drug or consumer product manufactured or
distributed by Seller or on behalf of Seller or any of its
Affiliates with respect to the Product in the Territory, such
article is not adulterated or misbranded within the meaning of the
FDCA, 21 U.S.C. §§ 351, 352 et. seq., and all Labeling of
Seller or its Affiliates with respect to the Product are otherwise
in conformance with applicable regulations.
(k) With
respect to the Product, Seller, its Affiliates and their respective
officers, employees, agents and affiliates have included or caused
to be included in the application for any drug, where required, the
certification described in 21 U.S.C. §335a(k)(l) and the list
described in 21 U.S.C. § 335a(k)(2), and such certification
and such list was in each case
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
true and
accurate, in all material respects, when made and remained true and
accurate in all material respects thereafter.
(l) To
the knowledge of Seller, with respect to the Product, contractors
of Seller and its Affiliates are in compliance with all applicable
Laws and, in respect of the FDA, have secured all licenses and
renewals necessary to their operation.
(m) As
to each commercial or investigational application or abbreviated
application submitted by Seller or any of its Affiliates for the
Product to, but not authorized or approved by, the FDA, and not
withdrawn by Seller or any of its Affiliates, or applicants acting
on their behalf as of the date of this Agreement, Seller and its
Affiliates have complied and are in compliance with, the
requirements of 21 U.S.C. §§ 355 and 21 C.F.R. Parts 312
and 314 and have provided all additional information and taken all
additional action reasonably requested by the FDA in connection
with the application.
(n) To
Seller’s knowledge, there are no lawsuits, actions,
arbitrations or legal or administrative or regulatory proceedings,
charges, complaints, or investigations by the FDA or any other
Governmental Authority pending against Seller or its Affiliates
with respect to any approved application, license, or registration
for the Product. To the knowledge of Seller, there are no
proceedings pending with respect to a violation by Seller or its
Affiliates of the FDCA, or PHSA, FDA regulations adopted
thereunder, or any other legislation or regulation promulgated by
any other Governmental Authority which might result in the
revocation, cancellation, suspension, limitation or adverse
modification of any approved application, license, or registration
with respect to the Product.
(o) Neither
Seller nor its Affiliates have been served with any complaint or
received any other notices of lawsuits, arbitrations, legal or
administrative or regulatory proceedings, charges, complaints or
investigations by any federal, state or foreign regulatory agency
threatened or pending against or relating to Seller or its
Affiliates or any approved application, license, or registration of
Seller or its Affiliates with respect to the Product. There have
been no product recalls, withdrawals, suspensions,
discontinuations, or similar actions by Seller or any of its
Affiliates (whether voluntary or otherwise) with respect to the
Product.
(p) To
the knowledge of Seller, no Person has filed a claim for loss or
potential loss under any indemnity covering participants in
clinical trials of the Product.
(q) To
the knowledge of Seller, all regulatory-related information with
respect to the manufacturing of the Product disclosed to Buyer by
Seller or any of its Affiliates is true and accurate in all
material respects and to the Seller’s knowledge, no
information has been omitted from such disclosures to Buyer that is
required to make the information actually disclosed to Buyer
materially complete or not materially misleading.
(r) [*
* *]
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
3.10 Condition of Manufacturing
Equipment.
The
Manufacturing Equipment is free from material defect, in good
operating condition and repair (ordinary wear and tear excepted),
has been maintained in accordance with normal industry practice,
and is suitable and adequate for the uses to which it is being put,
and, to the knowledge of Seller, none of the Manufacturing
Equipment is in need of maintenance or repairs, except for
ordinary, routine maintenance and repairs that are not material in
nature or cost. The Manufacturing Equipment is sufficient for the
continued conduct of the Business from and after the Closing Date
in substantially the same manner as conducted prior to the Closing,
subject to replacement for wear and tear obsolescence, provided
that Seller makes no representation or warranty with regard to
Buyer’s ability to continued manufacture of the Product with
sufficient quality or quantities in respect of the operation of the
Business by Buyer.
3.11 Inventory.
Seller
does not have any right, title or interest in any existing raw
materials, inventories of active pharmaceutical ingredients for the
Product, components, works-in-process or finished goods inventory
of the Product.
3.12 Brokers.
Except
as set forth on Schedule 3.12 , neither Seller nor any
Affiliate of Seller has engaged, or incurred any unpaid liability
for any brokerage fees, finders’ fees, commissions or
otherwise to any broker, finder or agent in connection with the
transactions contemplated by this Agreement.
3.13 Suppliers.
Seller
and its Affiliates have used reasonable business efforts to
maintain, and currently maintain, good working relationships with
all of its suppliers that supply products or services for the
Business, including clinical research organizations providing
services to Seller. There have been no material adverse changes in
the relationships during the past twelve (12) months between
Seller and such suppliers, including clinical research
organizations providing services to Seller.
Schedule 3.13 specifies for the period beginning
January 1, 2007 to the date of this Agreement the names of the
suppliers of the Product, suppliers of active pharmaceutical
ingredients to Seller and any clinical research organization
providing services to Seller that are material to the Business.
None of the suppliers or clinical research organizations set forth
in Schedule 3.13 has given Seller or any of its
Affiliates notice terminating, canceling or threatening to
terminate or cancel any contract or relationship with Seller or any
of its Affiliates relating to the manufacture of the Product by
Seller.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
3.14 Solvency.
(a) The
Purchase Price represents reasonably equivalent value for the
Assets.
(b) Seller
is acting in good faith and has no reason to believe that Buyer is
purchasing the Assets other than in good faith.
(c) Seller
is not entering into the Agreement with the intent to hinder, delay
or defraud any Person to which it is or may become indebted.
(d) Seller
(i) is not currently debtor or alleged debtor in a case filed
under the United States Bankruptcy Code, Title 11 U.S.C., as
amended (the “ Bankruptcy Code ”), (ii) is
not the subject of a receivership proceeding under any state law,
(iii) is not a party in any case providing for a collective
remedy among Seller’s creditors generally, (iv) is not
the subject of a present threat by another person or entity to
commence any of the foregoing proceedings against Seller, and
(v) has no present intention to commence any such proceeding
on their own behalf.
(e) As
of the date of this Agreement, Seller is, and as of the Closing
Date and immediately after the Closing Date, Seller will be, not
“insolvent,” as that term is defined in the text and
interpretive case law of the Bankruptcy Code.
(f) As
of the Closing Date, Seller is, and immediately after the Closing
Date Seller will be, able to pay its Liabilities as they
mature.
ARTICLE 4.
REPRESENTATIONS AND WARRANTIES BY BUYER
Buyer
represents and warrants to Seller as follows as of the Closing
Date:
4.01 Organization and
Standing.
Buyer
is a limited liability company duly organized, validly existing and
in good standing under the laws of the State of Delaware and is
duly qualified to do business in each jurisdiction where such
qualification is necessary. Buyer has the full power and authority
to enter into and perform the terms of this Agreement and the other
Related Documents to which it is a party and to carry out the
transactions contemplated hereby and thereby.
4.02 Authorization.
The
execution, delivery and performance of this Agreement and of the
other Related Documents to which Buyer is a party, and the
consummation of the transactions contemplated hereby and thereby,
have been duly and validly authorized by all necessary
actions
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
of Buyer
(none of which actions has been modified or rescinded and all of
which actions are in full force and effect). This Agreement
constitutes, and upon execution and delivery each such other
Related Document to which Buyer is a party will constitute, a valid
and binding agreement and obligation of Buyer, enforceable against
Buyer in accordance with its respective terms, except as the same
may be limited by bankruptcy, insolvency, reorganization,
moratorium and other similar laws of general applicability relating
to or affecting creditors’ rights generally and by the
application of general principles of equity.
4.03 Consents and Approvals; No
Conflicts.
(a) The
execution and delivery of this Agreement and the other Related
Documents to which Buyer is a party, and the performance of the
transactions contemplated herein by Buyer, will not require any
consent, approval, authorization or other action by, or filing with
or notification to, any Governmental Authority or other Person
which has not already been obtained.
(b) The
execution, delivery and performance by Buyer of this Agreement and
the other Related Documents to which Buyer is a party do not and
will not (i) conflict with or violate any Law applicable to
Buyer, (ii) conflict with or result in any breach of or
constitute a default (or an event which with notice or lapse of
time or both would become a default) of any Contract to which Buyer
is a party or by which Buyer is bound, or (iii) conflict with
or violate the organizational documents of Buyer.
4.04 Brokers.
Except
for Wachovia Securities, Buyer has not engaged, or incurred any
unpaid liability (for any brokerage fees, finders’ fees,
commissions or otherwise) to any broker, finder or agent in
connection with the transactions contemplated by this Agreement.
Buyer agrees to indemnify Seller (without limitation), against any
claims asserted against Seller for any such fees or commissions by
any Person purporting to act or to have acted for or on behalf of
Buyer. Notwithstanding any other provision of this Agreement, this
representation and warranty shall survive the Closing Date without
limitation.
ARTICLE 5.
REGULATORY MATTERS
5.01 Regulatory
Filings.
From
and after the Closing Date, to the extent necessary under
applicable Law, each of the parties hereto shall continue to use
all commercially reasonable efforts to take, or cause to be taken,
all appropriate action, and do, or cause to be done, all things
necessary, proper or advisable under applicable Laws or otherwise
to make effective the transactions contemplated
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
by this
Agreement as promptly as practicable, including, using all its
commercially reasonable efforts to transfer and obtain all
licenses, permits, consents, approvals, authorizations,
qualifications and orders of Governmental Authorities as are
necessary.
5.02 Responsibility for the
Product.
(a) Subject
to the Supply Agreement, from and after the Closing Date, Buyer
shall assume all regulatory responsibilities permitted by
applicable Laws to be assumed by Buyer, reporting and otherwise, in
connection with the Product, the Product Registrations, to the
extent related to the period from and after the Closing Date,
including responsibility for reporting any adverse drug experiences
in connection with the Product in or with respect to the Territory,
and responsibility for compliance with the Prescription Drug
Marketing Act of 1987, as the same may be amended from time to
time.
(b) Seller
and its Affiliates shall promptly submit to Buyer all written
medical i
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