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
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 1.
DEFINITIONS AND INTERPRETATIONS
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
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.
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.
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.
- 4 -
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.
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);
- 5 -
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.
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
- 6 -
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.
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
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.
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,
- 8 -
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.
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.
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
- 10 -
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.
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
- 11 -
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.
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.
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.
- 13 -
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.
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
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
- 14 -
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.
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
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
- 15 -
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.
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 inquiries,
adverse drug experience information or customer complaints received in writing by Seller or its
Affiliates in respect of the Product, as well as any material written notifications received by
Seller or its Affiliates concerning the safety or efficacy of the Product.
(c) From and after the Closing Date, Seller shall direct all complaints or inquiries
concerning the Product in the Territory to Buyer to the attention of
l , l , AXA Assistance USA, 000
Xxxxx Xxxxxxxx Xxxxxx, Xxxxx 0000, Xxxxxxx, Xxxxxxxx 00000 at the phone number l and facsimile
number l .
(d) Seller shall, and shall cause its Affiliates to, submit promptly to Buyer and its
Affiliates copies of all correspondence, documents, data, reports, information, files, including
third-party consulting reports, and records related thereto in its possession submitted to,
reported by, or provided to with respect to such Product complaints, inquiries or reports of
adverse drug reactions to any Governmental Authority pursuant to applicable Law.
ARTICLE 6.
ADDITIONAL COVENANTS
ADDITIONAL COVENANTS
6.01 Post-Closing Access and Cooperation.
(a) For a period of five (5) years after the Closing Date, Seller shall, and shall cause its
Affiliates to, reasonably cooperate with Buyer and to grant to Buyer and its employees, attorneys,
accountants, officers, representatives and agents, during normal business hours and upon reasonable
advance written notice, reasonable access to management personnel of Seller and its Affiliates and
to the records relating to the Assets and to permit copying at Buyer’s expense of documents
relating to the Assets for the purposes of (i) any financial reporting or Tax matters (including
any financial and Tax audits, Tax contests, Tax examinations, preparation of any Buyer Tax returns
or financial records) relating to the Assets or
- 16 -
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
the Product; (ii) any claims or litigation involving Buyer and any of the Assets; or
(iii) any investigation of Buyer being conducted by any federal, state, or local Governmental
Authority relating to the Assets. Seller shall maintain all such records and documents in the
United States and shall not destroy or dispose of any such records and documents without the prior
written consent of Buyer. Buyer shall use commercially reasonable efforts to ensure that its
access to and requests for records and documents pursuant to this Section 6.01(a) are
conducted so as not to interfere with the normal and ordinary operation of Seller’s business.
Buyer acknowledges that the records and documents made available to Buyer by Seller shall be
governed by the Confidentiality Agreement.
(b) For a period of five (5) years after the Closing Date, Buyer shall, and shall cause its
Affiliates to, reasonably cooperate with Seller and to grant to Seller and its employees,
attorneys, accountants, officers, representatives and agents, during normal business hours and upon
reasonable advance notice, reasonable access to management personnel of Buyer and its Affiliates
and to the records relating to the Assets during the period the Assets were owned by Seller and to
permit copying at Seller’s expense of documents relating to the Assets during the period the Assets
were owned by Seller for the purposes of (i) any financial reporting or Tax matters (including any
financial and Tax audits, Tax contests, Tax examinations, preparation of any Seller’s Tax Returns
or financial records) relating to the Product; (ii) any claims or litigation involving Seller and
the Assets relating to the Product; or (iii) any investigation of Seller’s actions prior to Closing
being conducted by any federal, state, or local Governmental Authority relating to the Product.
Buyer shall maintain all such records and documents in the United States and shall not destroy or
dispose of any such records and documents without the prior written consent of Seller. Seller
shall use commercially reasonable efforts to ensure that its access to and requests for records and
documents pursuant to this Section 6.01(b) are conducted so as not to interfere with the
normal and ordinary operation of Buyer’s business. Seller acknowledges that the records and
documents made available to Seller by Buyer shall be governed by Section 6.03(c).
6.02 Noncompetition Agreement.
(a) Except as set forth below, Seller covenants and agrees with Buyer that for a period
commencing on the Closing Date and ending upon the date of [* * *] (the “Noncompetition
Period”), neither Seller nor any of its Affiliates shall, directly or indirectly, engage in the
Business or develop, manufacture, import, distribute, package, test, market or sell, or assist any
Person in developing, manufacturing, importing, distributing, packaging, testing, marketing or
selling (i) any Competing Product (as defined below) in the Territory or (ii) any line extensions
or improvements on or to the Product or any Competing Product in the Territory. For purposes of
this Section 6.02(a), a “Competing Product” shall mean [* * *]
(b) In addition, Seller agrees that during the Noncompetition Period, if Seller or any of its
Affiliates shall sell, license, sublicense or otherwise transfer to any Person any rights
related to the MNP Technology, the Business or the Product outside of the Territory, then
Seller shall require that such Person agree in writing (for the benefit of Buyer), not to (i)
market,
- 17 -
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
sell or distribute a Competing Product using the MNP Technology in the Territory, or (ii)
sell or distribute such a Competing Product to another Person that intends to sell, market or
distribute such a Competing Product in the Territory.
(c) Seller and Buyer acknowledge and agree that a breach of any of Seller’s covenants set
forth in this Section 6.02 could cause irreparable harm to Buyer, that Buyer’s remedies at
law in the event of such breach would be inadequate, and that, accordingly, in the event of such
breach a restraining order, preliminary injunction or injunction or all of said remedies may be
issued against Seller and its Affiliates, in addition to any other rights and remedies that are
available to Buyer. If this Section 6.02 is more restrictive than permitted by the laws of
any jurisdiction in which a party hereto seeks enforcement hereof, this Section 6.02 shall
be limited to the extent required to permit enforcement under such laws. In particular, the
parties intend that the covenants contained in this Section 6.02 shall be construed as a
series of separate covenants, one for each state within the United States and one for each country
outside the United States. Except for geographic coverage, each such separate covenant shall be
deemed identical in terms. If, in any judicial proceeding, a court shall refuse to enforce any of
the separate covenants deemed included in this Section 6.02, then such unenforceable
covenant shall be deemed reduced in scope or duration, or eliminated from these provisions for the
purpose of those proceedings, to the extent necessary to permit the remaining separate covenants to
be enforced and this Section 6.02 to be given effect to the maximum extent permissible.
(d) If all or part of this Section 6.02 is held invalid, illegal or incapable of being
enforced by any governmental, administrative or judicial authority, all other terms and provisions
of this Agreement shall nevertheless remain in full force and effect. If any part of this
Section 6.02 is held to be excessively broad as to duration, scope, activity or subject,
such part will be construed by limiting and reducing it so as to be enforceable to the maximum
extent compatible with applicable Law.
(e) Notwithstanding any to the contrary herein, if Seller shall consummate a Change of Control
transaction with an unrelated third party, then the provisions of this Section 6.02 shall
not apply to in any way limit, prohibit or restrict the development, manufacture or sale of a
Competing Product (whether as of or following the Change in Control) by or on behalf of such third
party. A “Change in Control” shall be defined as any consolidation or merger of Seller
with or into any other Person, or any other corporate reorganization (other than any such
transaction following which the stockholders of Seller immediately prior to such consolidation,
merger or reorganization, retain, by virtue of their equity interest in Seller at least fifty
percent (50%) of the voting power of the surviving corporation immediately after such
consolidation, merger or reorganization) or any transaction or series of related transactions to
which Seller is a party in which in excess of fifty percent (50%) of Seller’s voting power is
transferred; or a sale, lease, exclusive license or other disposition of all or substantially all
of the assets of Seller.
- 18 -
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
6.03 Confidentiality.
(a) Buyer acknowledges that the information previously provided to it in connection with this
Agreement and the consummation of the other transactions contemplated hereby is subject to the
terms of the Confidentiality Agreement between Buyer and Seller dated as of November 2, 2007 (the
“Confidentiality Agreement”), the terms of which are incorporated herein by reference.
Effective upon, and only upon, the Closing, Buyer’s obligations under the Confidentiality Agreement
shall terminate with respect to information relating to the Business or otherwise included in the
Assets or relating to the Product; provided, that Buyer acknowledges that any and all other
information provided to it by Seller or Seller’s representatives concerning Seller and its
Affiliates shall remain subject to the terms and conditions of the Confidentiality Agreement from
and after the Closing Date. Notwithstanding the foregoing, Seller acknowledges and agrees that
Buyer may publicly disclose information subject to the Confidentiality Agreement that relates to
the Business (i) if and to the extent required by applicable Law, rule or regulation, (ii) with the
consent of Seller (not to be unreasonably withheld) or (iii) as expressly provided in the License
Agreement.
(b) Each of Buyer and Seller agrees that the terms of this Agreement and the Related Documents
shall not be disclosed or otherwise made available to the public and that copies of this Agreement
and the Related Documents shall not be publicly filed or otherwise made available to the public,
except where such disclosure, availability or filing is required by applicable Law or the rules of
any nationally recognized securities exchange and only to the extent required by such Law or the
rules of any nationally recognized securities exchange. In the event that such disclosure,
availability or filing is required by applicable Law, each of Buyer and Seller (as applicable)
agrees to use commercially reasonable efforts to obtain “confidential treatment” of this Agreement
and the Related Documents with the U.S. Securities and Exchange Commission (or the equivalent
treatment by any other Governmental Authority) and to use commercially reasonable efforts to redact
such terms of this Agreement and the Related Documents as the other party shall request.
Notwithstanding the foregoing, the parties have approved and are issuing on the date hereof the
press release attached hereto as Exhibit D.
(c) Seller shall keep confidential and shall not use, and shall cause its Affiliates,
officers, directors, employees, advisors, successors, assigns, licensees and sublicensees, and the
officers, directors, employees, advisors, successors, assigns, licensees and sublicensees of
Seller’s Affiliates, to keep confidential, all information relating to the Business, the Product
and the Assets, and all other confidential or proprietary information of Buyer and its Affiliates
(collectively, “Buyer Confidential Information”). Seller’s obligations under this
Section 6.03(c) shall not apply to information that Seller can demonstrably prove (i) is,
or later becomes, generally available to the public through no fault of Seller or its Affiliates,
(ii) is obtained from a third party not under an obligation of confidentiality, or (iii) is
required by Law or administrative process to be disclosed. If required by order of any Government
Authority, Seller may disclose to such Government Authority, data, information, or materials
pertaining to or involving the Buyer Confidential Information solely to the extent required by such
order; provided, that Seller shall first have notified Buyer of the required disclosure and
provided
- 19 -
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
reasonable cooperation to Buyer in Buyer’s efforts to obtain a protective order to
maintain the confidentiality of such data, information or materials. Nothing in this Section
6.03 shall limit or restrict the disclosure or use of Buyer Confidential Information solely to
the extent as expressly permitted under the terms of Section 6.05 of this Agreement or the
express terms of the License Agreement or the express terms of the Supply Agreement.
(d) Seller and Buyer acknowledge and agree that a breach of any of Seller’s covenants set
forth in Section 6.03(c) would cause irreparable harm to Buyer, that Buyer’s remedies at
law in the event of such breach would be inadequate, and that, accordingly, in the event of such
breach a restraining order, preliminary injunction or injunction or all of said remedies may be
issued against Seller and its Affiliates, in addition to any other rights and remedies that are
available to Buyer.
6.04 Use of Certain Names.
(a) Except as set forth in this Section 6.04, Buyer shall promptly, and in any event
within [* * *] after the Closing Date, complete the revision of advertising and promotional
materials and all Product literature relating to the Product (i) to delete all references to the
Names and (ii) to delete all references to Seller’s or its Affiliates’ customer service address or
phone number; provided, that for a period of [* * *] after the Closing Date, Buyer may
continue to distribute such advertising and promotional materials and Product literature that uses
any Names, addresses or phone numbers to the extent that such literature exists on the Closing
Date, and provided further, that the Names may remain on any promotional materials and
literature and advertising materials relating to the Product to the extent required by Law or any
Governmental Authority for any reason. Subject to the terms and conditions herein, Seller and its
Affiliates hereby grant a non-exclusive, non-transferable, fully-paid, royalty-free right and
license to Buyer and its Affiliates to use the Names on the promotional materials and literature
and advertising materials relating to the Product, to the limited extent and for not longer than
the [* * *] period specified herein. Buyer will destroy their inventory of any remaining
promotional materials and literature and advertising materials relating to the Product in their
possession bearing the Names, address, or phone number, which Names, address and phone numbers are
not deleted pursuant to this Section 6.04(a) within [* * *] after the Closing Date. In no
event shall Buyer use any of the Names after the Closing Date in any manner or for any purpose
other than as set forth in this Section 6.04(a).
(b) Seller hereby grants a non-exclusive and royalty free right and license to Buyer under the
Names to the extent necessary to allow Buyer and its Affiliates and their designees to market,
distribute and sell the Product utilizing the Labeling existing on the Closing Date as and to the
extent set forth above and for a period not to exceed [* * *].
6.05 Retained Copy of Data.
(a) Buyer agrees that Seller shall be entitled to retain (or to reasonably request that Buyer
assist it in obtaining at Seller’s sole cost and expense) a complete copy of the NDA
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
and IND for
the Product in existence as of the date hereof, together with copies of any clinical data related
to the Product in Seller’s possession as of the date hereof that is not included in the NDA or IND
(collectively the “Retained Copies”). Seller and its successors, assigns, licensees and
sublicensees shall be permitted to use the Retained Copies solely for purposes of seeking,
obtaining and maintaining regulatory approvals for the Product outside the Territory. Except for
disclosure of information in the Retained Copies to Governmental Authorities for such purposes,
Seller shall, and shall cause its successors, assigns, licensees and sublicensees to, keep strictly
confidential and not use the information contained in the Retained Copies except as permitted in
accordance with Section 6.03 or this Section 6.05. Notwithstanding anything to the
contrary in this Section 6.05 or otherwise, Seller acknowledges and agrees that to the
extent included in the Assets, (a) the Retained Copies and all information and data contained
therein constitute valuable, proprietary trade secrets and confidential information of Buyer, (b)
Buyer reserves and retains all right, title and interest in the Retained Copies and all information
and data contained therein, subject to Seller’s rights under this Section 6.05 and (c)
Seller shall not assert any right, title or interest in or to the Retained Copies or the
information or data contained therein, except for Seller’s rights under this Section 6.05.
(b) If Seller or any of its Affiliates shall sell, license, sublicense or otherwise transfer
to any Person any rights primarily related to the MNP Technology, the Business or the Product
outside of the Territory, then Seller shall require that such Person agree in writing (for the
benefit of Buyer), not to (i) market, sell or distribute a product using the Retained Copies or the
information and data contained therein in the Territory, or (ii) sell or distribute such a product
to another Person that intends to sell, market or distribute such a product in the Territory and
shall include in the terms of each such license, sublicense or transfer provisions to the effect
that (A) any breach of this limitation shall constitute a material breach subject to injunctive
relief and (B) the licensee, sublicense or transferee, as the case may be, shall submit to venue
and jurisdiction in New York for enforcement of any breach.
6.06 Drug Master Files.
From and after the Closing Date, Seller and its Affiliates shall cooperate with Buyer in
obtaining from the applicable third parties rights to access and reference all Drug Master Files,
including all data, information and records contained therein, for the Product’s active
pharmaceutical ingredients.
ARTICLE 7.
CONDITIONS TO CLOSING
CONDITIONS TO CLOSING
7.01 Conditions to Obligations of Buyer.
The obligation of Buyer to effect the transactions contemplated by this Agreement shall be
further subject to the satisfaction or waiver by Buyer at or prior to the Closing of each of the
following conditions:
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(a) The representations and warranties of Seller made in this Agreement (including the
Schedules) and the Related Documents that are qualified as to materiality shall be true and
correct, and those not so qualified shall be true and correct in all material respects as of the
Closing Date as though made on the Closing Date, except to the extent such representations and
warranties expressly relate to an earlier date (in which case such representations and warranties
qualified as to materiality shall be true and correct, and those not so qualified shall be true and
correct in all material respects, on and as of such earlier date).
(b) Seller shall have performed in all material respects all obligations and covenants
required to be performed or complied with by Seller under this Agreement by the time of Closing.
(c) Seller shall have delivered or caused to be delivered to Buyer each of the documents
specified in Section 8.02.
(d) All license, sublicense, development and other Contracts purporting to grant any rights in
the Product or the Assets to any Person, including the Esprit License Agreement, shall have been
terminated on terms and conditions satisfactory to Buyer, and Seller shall have delivered to Buyer
written evidence of such terminations.
(e) Buyer shall have entered into the Supply Agreement with Seller for the manufacture and
supply of the Product to Buyer on terms and conditions satisfactory to Buyer and Seller.
(f) Buyer shall have consummated the closing under the AGN Asset Purchase Agreement
simultaneously with the consummation of the Closing under this Agreement.
7.02 Conditions to Obligations of Seller.
The obligation of Seller to effect the transactions contemplated by this Agreement shall be
further subject to the satisfaction or waiver at or prior to the Closing of each of the following
conditions:
(a) The representations and warranties of Buyer made in this Agreement and the Related
Documents that are qualified as to materiality shall be true and correct, and those not so
qualified shall be true and correct in all material respects as of the Closing Date as though made
on the Closing Date, except to the extent such representations and warranties expressly relate to
an earlier date (in which case such representations and warranties qualified as to materiality
shall be true and correct, and those not so qualified shall be true and correct in all material
respects, on and as of such earlier date).
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(b) Buyer shall have performed in all material respects all obligations and covenants required
to be performed or complied with by Buyer under this Agreement by the time of Closing.
(c) Buyer shall have delivered or caused to be delivered to Seller each of the documents
specified in Section 8.03.
(d) Buyer shall have executed and delivered the License Agreement.
(e) Buyer shall have consummated the closing under the AGN Asset Purchase Agreement
simultaneously with the consummation of the Closing under this Agreement.
(f) Buyer shall have entered into the Supply Agreement with Seller for the manufacture and
supply of the Product to Buyer on terms and conditions satisfactory to Buyer and Seller.
ARTICLE 8.
CLOSING
CLOSING
8.01 Time and Place of Closing.
The closing of the purchase and sale of the Assets pursuant to this Agreement (the
“Closing”) shall take place on the date of this Agreement (the “Closing Date”) at
the offices of XxXxxxxxx Will & Xxxxx LLP, 600 13th Street, N.W., Washington, D.C., or at such
other time and place as the parties may agree in writing.
8.02 Delivery by Seller.
At the Closing, Seller shall deliver to Buyer the following:
(a) The following instruments of transfer duly executed by Seller (or, if applicable, its
Affiliate):
(i) | the Xxxx of Sale; | ||
(ii) | the Assignment of Patents; and | ||
(iii) | the Assignment of Trademarks. |
(b) Copies of documents, materials and files required to be delivered by Seller to Buyer at
Closing pursuant to this Agreement, including (i) a complete copy of the Product Registrations and
other materials set forth in Section 2.01(c); and (ii) copies of the materials comprising
the Books and Records described in Section 2.01(d). If the documents,
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
materials and files
in items (i) and (ii) are not available to Seller at Closing, Seller may deliver such documents,
materials and files to Buyer promptly upon becoming available to Seller and in any case within
thirty (30) days following the Closing.
(c) Duly executed releases and termination statements to the extent necessary to release any
Encumbrances on the Assets.
(d) Any other documents or instruments reasonably requested by Buyer.
8.03 Delivery by Buyer.
At the Closing, Buyer shall deliver to Seller the Purchase Price in the amount and manner set
forth in Section 2.04 and Section 2.05.
ARTICLE 9.
SURVIVAL; INDEMNIFICATION
SURVIVAL; INDEMNIFICATION
9.01 Survival of Representations.
All representations and warranties, covenants and agreements of Seller and Buyer contained in
or made pursuant to this Agreement, in any Related Document, or in any certificate furnished
pursuant hereto shall survive the Closing Date and shall remain in full force and effect to the
following extent: (a) representations and warranties of Seller and Buyer in Articles 3 and
4, respectively, shall remain in full force and effect for a period of [* * *] years from
and after the Closing Date (except for the representations and warranties of Seller set forth in
Section 3.12); (b) the representation and warranties of Seller set forth in Section
3.12 shall survive in perpetuity; and (c) the covenants and agreements of Buyer and Seller set
forth in this Agreement shall remain in full force and effect until fully discharged in accordance
with the express terms thereof; provided, however, that, in all cases, any
representation, warranty, covenant or agreement that is the subject of a claim which occurred prior
to the expiration of the applicable survival period is asserted by the party seeking
indemnification hereunder in a reasonably detailed writing delivered to the other party or parties,
as the case may be, prior to the expiration of the applicable survival period shall survive with
respect to such claim or dispute until the final resolution thereof.
9.02 Indemnification by Seller.
Subject to the conditions and provisions of Section 9.04 and Section 9.05,
from and after the Closing Date, Seller shall indemnify, defend and hold harmless Buyer and Buyer’s
officers, directors, employees, agents and shareholders (“Buyer Indemnified Parties”) from
and against and in any respect of any and all Losses, asserted against, resulting to, imposed upon
or incurred by any Buyer Indemnified Parties, directly or indirectly, by reason of or resulting
from: (a) any misrepresentation or breach of the representations, warranties and certifications of
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
contained in or made pursuant to this Agreement; (b) any breach by Seller of any
post-Closing covenants of Seller contained in or made pursuant to this Agreement; or (c) the
Excluded Liabilities.
9.03 Indemnification by Buyer.
Subject to the conditions and provisions of Section 9.04 and Section 9.05,
from and after the Closing Date, Buyer hereby agrees to indemnify, defend and hold harmless Seller,
and officers, directors, employees, agents and partners of Seller (“Seller Indemnified
Parties”) from, against and with respect of any and all Losses, asserted against, resulting to,
imposed upon or incurred by any Seller Indemnified Parties, directly or indirectly, by reason of or
resulting from: (a) any misrepresentation or breach of the representations, warranties and
certifications of Buyer (without giving effect to any materiality or material adverse effect
qualifiers set forth therein) contained in or made pursuant to this Agreement; or (b) any breach by
Buyer of any post-Closing covenants of Buyer contained in or made pursuant to this Agreement.
9.04 Limitations on Indemnification.
(a) Subject to Section 9.04(e), Seller shall not be liable to the Buyer Indemnified
Parties in respect of any indemnification for Losses under Section 9.02(a) unless and until
the aggregate of such Losses exceeds [* * *] (the “Threshold Amount”), in which event
Seller shall be liable for indemnification pursuant to Section 9.02(a) for only the
aggregate amount of all such Losses in excess of the Threshold Amount, up to the maximum amount set
forth in Section 9.04(b).
(b) Subject to Section 9.04(e), the maximum aggregate liability of Seller to the Buyer
Indemnified Parties in respect of any indemnification under Section 9.02(a) shall not
exceed [* * *] (the “Indemnity Cap”).
(c) Subject to Section 9.04(f), Buyer shall not be liable to the Seller Indemnified
Parties in respect of any indemnification for Losses under Section 9.03(a) unless and until
the aggregate of such Losses exceeds the Threshold Amount, in which event Buyer shall be liable for
indemnification pursuant to Section 9.03(a) for only the aggregate amount of all such
Losses in excess of the Threshold Amount, up to the maximum amount set forth in Section
9.04(d).
(d) Subject to Section 9.04(f), the maximum liability of Buyer to the Seller
Indemnified Parties in respect of any indemnification under Section 9.03(a) shall not
exceed the Indemnity Cap.
(e) The limitations on liability set forth in Section 9.04(a) and Section
9.04(b) shall not apply with respect to Losses resulting from (i) any breach of any of the
representations and warranties of Seller set forth in Section 3.12, (ii) Seller’s fraud in
connection with the transactions contemplated hereby; and (iii) any breach by Seller, or any
failure of 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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
to perform, any of the post-Closing covenants, agreements or obligations
contained in or made pursuant to this Agreement.
(f) The limitations on liability set forth in Section 9.04(c) and Section
9.04(d) shall not apply with respect to Losses resulting from (i) any breach of any of the
representations and warranties of Buyer set forth in Section 4.04, (ii) Buyer’s fraud in
connection with the transactions contemplated hereby; and (iii) any breach by Buyer, or any failure
of Buyer to perform, any of the post-Closing covenants, agreements or obligations contained in or
made pursuant to this Agreement.
9.05 Conditions of Indemnification.
The obligations and liabilities of Seller and of Buyer hereunder with respect to their
respective indemnities pursuant to this Article 9, resulting from any Losses, shall be
subject to the following terms and conditions:
(a) The party seeking indemnification (the “Indemnified Party”) must give the other
party or parties, as the case may be (the “Indemnifying Party”), notice of any such Losses
promptly after the Indemnified Party receives notice thereof; provided, that the failure to
give such notice shall not affect the rights of the Indemnified Party hereunder except to the
extent that the Indemnifying Party shall have suffered actual damage by reason of such failure.
(b) The Indemnifying Party shall have the right to undertake, by counsel or other
representatives of its own choosing (reasonably acceptable to the Indemnified Party), the defense
of such Losses at the Indemnifying Party’s risk and expense; provided, however,
that the Indemnifying Party shall not have the right to defend against such Losses, and the
provisions of Section 9.05(c) shall apply with respect to the defense of such Losses, if
Buyer reasonably determines (after consultation with Seller) that the amount of such Losses are
reasonably expected to exceed the limitations of liability of the Indemnifying Party set forth in
Section 9.04.
(c) In the event that the Indemnifying Party shall elect not to undertake such defense, or,
within a reasonable time after notice from the Indemnified Party of any such Losses, shall fail to
defend, the Indemnified Party (upon further written notice to the Indemnifying Party) shall have
the right to undertake the defense, compromise or settlement of such Losses, by counsel or other
representatives of its own choosing, on behalf of and for the
account and risk of the Indemnifying Party (subject to the right of the Indemnifying Party to
assume defense of such Losses at any time prior to settlement, compromise or final determination
thereof (with counsel reasonably acceptable to the Indemnified Party)).
(d) Anything in this Section 9.05 to the contrary notwithstanding, (i) the
Indemnifying Party shall not, without the Indemnified Party’s written consent (which consent shall
not be unreasonably withheld, conditioned or delayed), settle or compromise any Losses or consent
to entry of any judgment which does not include as an unconditional term thereof the giving by the
claimant or the plaintiff to the Indemnified Party of a release from all liability in
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
respect of
such Losses in form and substance reasonably satisfactory to the Indemnified Party, (ii) in the
event that the Indemnifying Party undertakes defense of any Losses, the Indemnified Party, by
counsel or other representative of its own choosing and at its sole cost and expense, shall have
the right to consult with the Indemnifying Party and its counsel or other representatives
concerning such Losses and the Indemnifying Party and the Indemnified Party and their respective
counsel or other representatives shall cooperate with respect to such Losses, (iii) in the event
that the Indemnifying Party undertakes defense of any Losses, the Indemnifying Party shall have an
obligation to keep the Indemnified Party reasonably informed of the status of the defense of such
Losses and furnish the Indemnified Party with all documents, instruments and information that the
Indemnified Party shall reasonably request in connection therewith, and (iv) in the event that both
the Indemnified Party and the Indemnifying Party are parties (directly or through interpleader) to
any Losses giving rise to indemnification hereunder and the Indemnified Party is advised by counsel
that there is a conflict of interest in the representation of both the Indemnified Party and the
Indemnifying Party by one firm of counsel, the Indemnified Party shall be entitled to assume, at
the sole cost and expense of the Indemnifying Party, the defense, compromise and settlement
(subject to clause (i) above) of such Loss with one counsel (in addition to local counsel)
reasonably satisfactory to the Indemnifying Party.
(e) In the event that an Indemnified Party has a good faith basis for a claim for
indemnification which does not involve a claim against it by a third party (a “Direct
Claim”), the Indemnified Party shall notify the Indemnifying Party in writing of such Direct
Claim with reasonable promptness, specifying, to the extent known, the nature, circumstances and
amount of such Direct Claim, including with particularity the specific representation and warranty
or covenant and agreement alleged to have been breached; provided, that the failure to give
such notice shall not affect the rights of the Indemnified Party hereunder except to the extent
that the Indemnifying Party shall have suffered actual damage by reason of such failure. If the
Indemnifying Party notifies the Indemnified Party that it disputes an Indemnified Party’s right of
indemnification with respect to a particular Direct Claim, the parties shall use their reasonable
efforts to negotiate a resolution of such dispute promptly. Except to the extent of the
limitations on indemnification set forth in this Article 9, nothing in this Section
9.05(e) shall be deemed to prevent any Indemnified Party from initiating litigation under this
Agreement with respect to any Direct Claim disputed by the Indemnifying Party for the purpose of
establishing the Indemnified Party’s right to indemnification hereunder.
9.06 Indemnification in the Case of Indemnified Party Negligence.
THE INDEMNIFICATION PROVIDED IN THIS ARTICLE 9 WITH RESPECT TO ANY BREACH OF A
REPRESENTATION OR WARRANTY OF A PARTY SHALL BE APPLICABLE WHETHER OR NOT THE SOLE OR CONCURRENT
NEGLIGENCE OF THE INDEMNIFIED PARTY, OR THE SOLE OR CONCURRENT STRICT LIABILITY IMPOSED ON THE
INDEMNIFIED PARTY, OR THE SOLE OR CONCURRENT LIABILITY IMPOSED VICARIOUSLY ON THE INDEMNIFIED
PARTY, IS ALLEGED OR PROVEN.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
9.07 Disclaimer.
IN NO EVENT SHALL THE INDEMNIFICATION OBLIGATIONS UNDER THIS ARTICLE 9 OR OTHERWISE
UNDER THIS AGREEMENT OR THE TERM “LOSSES” COVER OR INCLUDE CONSEQUENTIAL, INCIDENTAL, SPECIAL,
INDIRECT, OR PUNITIVE DAMAGES OR LOST PROFITS SUFFERED BY AN INDEMNIFIED PARTY, NOR SHALL ANY
DAMAGES BE CALCULATED USING A “MULTIPLIER” OR ANY OTHER SIMILAR METHOD HAVING A SIMILAR EFFECT,
WHETHER BASED ON STATUTE, CONTRACT, TORT OR OTHERWISE, AND WHETHER OR NOT ARISING FROM THE
INDEMNIFYING PARTY’S SOLE, JOINT OR CONCURRENT NEGLIGENCE, STRICT LIABILITY OR TORT.
9.08 Sole and Exclusive Remedy.
Except for any equitable relief to which the Buyer Indemnified Parties, on the one hand, and
the Seller Indemnified Parties, on the other hand may be entitled (including pursuant to
Section 10.01), and for claims based upon fraud, the indemnification provided in this
Article 9 shall be the sole and exclusive post-Closing recourse and remedy available to the
Buyer Indemnified Parties, on the one hand, and the Seller Indemnified Parties, on the other hand,
for any claim under or related to this Agreement or the transactions contemplated hereby, including
any breach or non-performance of any representation, warranty, covenant or agreement contained
herein. Except for any equitable relief to which Buyer Indemnified Parties, on the one hand, and
the Seller Indemnified Parties, on the other hand may be entitled (including pursuant to
Section 10.01), and for claims based upon fraud, no party (and no Affiliate of any party)
may commence any suit, action or proceeding against any other party hereto or any of their
respective Affiliates with respect to the subject matter of this Agreement, whether in contract,
tort or otherwise, except to enforce such party’s express rights under this Article 9. The
provisions of this Article 9 were specifically bargained for and reflected in the amounts
payable to the Seller Indemnified Parties in connection with the consummation of the transactions
contemplated by this Agreement.
9.09 Indemnity Payments [* * *].
It is the intention of the parties to treat any indemnity payment made under this Agreement [*
* *].
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 10.
GENERAL PROVISIONS
GENERAL PROVISIONS
10.01 Specific Performance.
Seller hereby acknowledges that the Assets are unique, and that the harm to Buyer resulting
from Seller’s failure to perform their obligations hereunder cannot be adequately compensated by
damages. Accordingly, Seller agrees that Buyer shall have the right to have all obligations,
undertakings, agreements, covenants and other provisions of this Agreement specifically performed
by Seller. In any such specific performance action, Seller agrees to waive the defense that there
is an adequate remedy at law for damages and agree that Buyer shall be entitled to obtain specific
performance of Seller’s obligations hereunder without having to post any bond or other security in
any such proceeding.
10.02 Additional Actions, Documents and Information.
Buyer agrees that it will, at any time, at or after the Closing Date, take or cause to be
taken such further actions, and execute, deliver and file or cause to be executed, delivered and
filed such further documents and instruments and obtain such consents, as may be reasonably
requested by Seller in connection with the consummation of the transactions contemplated by this
Agreement. Seller agrees that it will, at any time, at or after the Closing Date, take or cause to
be taken such further actions, and execute, deliver and file or cause to be executed, delivered and
filed such further documents and instruments and obtain such consents, as may be reasonably
requested by Buyer in connection with the consummation of the transactions contemplated by this
Agreement, including, in the event that any Assets are owned by any Affiliate of Seller, causing
such Affiliate to transfer the Assets to Buyer.
10.03 Expenses and Taxes.
Each party hereto shall pay its own expenses incurred in connection with this Agreement and in
the preparation for and consummation of the transactions provided for herein. Notwithstanding the
foregoing, Buyer shall pay [* * *] and Seller shall pay [* * *] of all sales, use, documentary,
stamp, gross receipts, registration, transfer, conveyance, excise, recording, license and other
similar Taxes and fees (“Transfer Taxes”) applicable to, imposed upon or arising out of the
transactions contemplated hereby whether now in effect or hereinafter adopted and regardless of
which party such Transfer Tax is imposed upon. Each party agrees to cooperate with such other
party in the timely completion, execution and filing of any
documentation required by any local or state governmental agency in connection with the
Transfer Taxes.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
10.04 Notices.
All notices, demands, requests, or other communications which may be or are required to be
given or made by any party to any other party pursuant to this Agreement shall be in writing and
shall be hand delivered, mailed by first-class registered or certified mail, return receipt
requested, postage prepaid, delivered by overnight air courier, or transmitted by telegram, telex,
or facsimile transmission addressed as follows:
If to Seller:
Novavax, Inc.
0000 Xxxxxxx Xxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxx Xxxx
0000 Xxxxxxx Xxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxx Xxxx
with a copy to:
Xxxxxx Godward Kronish LLP
One Freedom Square
Reston Town Center
00000 Xxxxxxx Xxxxx
Xxxxxx, XX 00000-0000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxxxxxx X. Xxxxxx, Esq.
One Freedom Square
Reston Town Center
00000 Xxxxxxx Xxxxx
Xxxxxx, XX 00000-0000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxxxxxx X. Xxxxxx, Esq.
If to Buyer, to:
Graceway Pharmaceuticals, LLC
000 Xxxxxx Xxxxxx Xxxx Xx. Xxxx.
Xxxxx 000
Xxxxxxx, Xxxxxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: General Counsel
000 Xxxxxx Xxxxxx Xxxx Xx. Xxxx.
Xxxxx 000
Xxxxxxx, Xxxxxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: General Counsel
with a copy to:
XxXxxxxxx Will & Xxxxx LLP
000 00xx Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000-0000
000 00xx Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000-0000
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxxxxx X. Xxxxx, Esq.
Facsimile: (000) 000-0000
Attention: Xxxxxx X. Xxxxx, Esq.
or such other address as the addressee may indicate by written notice to the other parties.
Each notice, demand, request, or communication which shall be given or made in the manner
described above shall be deemed sufficiently given or made for all purposes at such time as it is
delivered to the addressee (with the return receipt, the delivery receipt, the affidavit of
messenger or (with respect to a telex) the answerback being deemed conclusive but not exclusive
evidence of such delivery) or at such time as delivery is refused by the addressee upon
presentation.
10.05 Waiver.
No delay or failure on the part of any party hereto in exercising any right, power or
privilege under this Agreement or under any other instrument or document given in connection with
or pursuant to this Agreement shall impair any such right, power or privilege or be construed as a
waiver of any default or any acquiescence therein. No single or partial exercise of any such
right, power or privilege shall preclude the further exercise of such right, power or privilege, or
the exercise of any other right, power or privilege. No waiver shall be valid against any party
hereto unless made in writing and signed by the party against whom enforcement of such waiver is
sought and then only to the extent expressly specified therein.
10.06 Assignment.
Neither this Agreement nor any of the rights, interests or obligations hereunder shall be
assigned by any of the parties hereto (whether by operation of law or otherwise) without the prior
written consent of the other party; provided, that Buyer may assign this Agreement to an
Affiliate of Buyer, but any such assignment shall not relieve Buyer of Buyer’s obligations
hereunder and provided, that Seller shall be permitted, to the extent necessary, to assign
all, but not less than all, of Seller’s rights under this Agreement to a buyer in a Change of
Control transaction if such buyer shall agree in writing to be bound by the terms and conditions of
this Agreement. Subject to the preceding sentence, this Agreement shall be binding upon, inure to
the benefit of and be enforceable by the parties and their respective successors and assigns.
10.07 Entire Agreement; Amendment.
This Agreement, including the Schedules, Exhibits and Annexes hereto, the Confidentiality
Agreement, the Supply Agreement, the License Agreement and the other instruments and documents
referred to herein or delivered pursuant hereto contains the entire agreement among the parties
with respect to the subject matter hereof and supersedes all prior oral or written agreements,
commitments or understandings with respect to such matters. No
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
amendment, modification or
discharge of this Agreement shall be valid or binding unless set forth in writing and duly executed
by the party or parties against whom enforcement of the amendment, modification or discharge is
sought.
10.08 Severability.
If any part of any provision of this Agreement or any other Contract, document or writing
given pursuant to or in connection with this Agreement shall be invalid or unenforceable under
applicable Law, such part shall be ineffective to the extent of such invalidity or unenforceability
only, without in any way affecting the remaining parts of such provisions or the remaining
provisions of said contract, document or writing.
10.09 Table of Contents; Headings.
The Table of Contents and headings of the sections and subsections contained in this Agreement
are inserted for convenience only and do not form a part or affect the meaning, construction,
interpretation or scope thereof.
10.10 Construction.
The construction of this Agreement shall not take into consideration the party who drafted or
whose representative drafted any portion of this Agreement, and no canon of construction shall be
applied that resolves ambiguities against the drafter of a document. Each party acknowledges that:
(a) it has read this Agreement; (b) it has been represented in the preparation, negotiation and
execution of this Agreement by legal counsel of its own choice or has voluntarily declined to seek
such counsel; and (c) it understands the terms and consequences of this Agreement and is fully
aware of the legal and binding effect of this Agreement.
10.11 Waiver of Bulk Sales.
Seller and Buyer waive compliance with any bulk sales law or similar law in connection with
the consummation of the transactions contemplated herein.
10.12 Governing Law; Jurisdiction.
This Agreement, the rights and obligations of the parties hereto, and any claims or disputes
relating thereto, shall be governed by and construed under and in accordance with the laws of the
State of New York, without giving effect to the conflicts of law principles thereof (other than
Section 5-1401 of the New York General Obligations Law). The parties hereto hereby waive personal
service of any process in connection with any such action, suit or proceeding and agree that the
service thereof may be made by certified or registered mail addressed to or by personal delivery to
the other party, at such other party’s address set forth
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
pursuant to Section 10.04 hereof.
In the alternative, in its discretion, any of the parties hereto may effect service upon any other
party in any other form or manner permitted by Law.
10.13 Signature in Counterparts.
This Agreement may be executed in separate counterparts, none of which need contain the
signatures of all parties, each of which shall be deemed to be an original, and all of which taken
together constitute one and the same instrument. It shall not be necessary in making proof of this
Agreement to produce or account for more than the number of counterparts containing the respective
signatures of, or on behalf of, all of the parties hereto.
[The remainder of this page intentionally left blank.]
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
IN WITNESS WHEREOF, each of the parties hereto has executed this Asset Purchase Agreement, or
has caused this Asset Purchase Agreement to be duly executed and delivered in its name on its
behalf, all as of the day and year first above written.
SELLER NOVAVAX, INC. |
||||
By: | /s/ Xxxxxxx X. Xxxx, Xx. | |||
Name: | Xxxxxxx X. Xxxx, Xx. | |||
Title: | SVP Commercial Operations | |||
BUYER GRACEWAY PHARMACEUTICALS, LLC |
||||
By: | /s/ Xxxxxxxxx X. Xxxxxxx | |||
Name: | Xxxxxxxxx X. Xxxxxxx | |||
Title: | Chairman and CEO | |||
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ANNEX I
DEFINITIONS
DEFINITIONS
“Affiliate” shall mean, with respect to any Person, any other Person that,
(a) directly or indirectly is in control of, is controlled by, or is under common control with, the
first Person, (b) is an officer, director, trustee, partner (general or limited), employee or
holder of ten percent (10%) or more of any class of any voting or non-voting securities or other
equity in the first Person, and (c) is an officer, director, trustee, partner (general or
limited), employee or holder of ten percent (10%) or more of any class of the voting or non-voting
securities or other equity in any Person which directly or indirectly is in control of, is
controlled by, or is under common control with, the first Person. For purposes of this definition,
“control” (including with correlative meanings “controlled by” and “under common control with”)
shall mean possession, directly or indirectly, of either (i) ten percent (10%) or more of the
voting power of the securities having ordinary voting power for the election of directors of the
first Person, or (ii) the power to direct or cause the direction of the management or policies of
the first Person (whether through ownership of securities, partnership interests or any other
ownership or debt interests, by contract or otherwise).
“AGN Asset Purchase Agreement” shall have the meaning set forth in the Recitals.
“Agreement” shall have the meaning set forth in the Preamble.
“Allergan” shall have the meaning set forth in the Recitals.
“Assets” shall have the meaning set forth in Section 2.01.
“Assigned Intellectual Property” shall have the meaning set forth in
Section 2.01(a).
“Assignment of Patents” means that certain Assignment of Patents executed by Seller in
the form attached hereto as Exhibit A.
“Assignment of Trademarks” means that certain Assignment of Trademarks executed by
Seller in the form attached hereto as Exhibit B.
“Bankruptcy Code” shall have the meaning set forth in Section 3.14(d).
“Xxxx of Sale” means that certain Xxxx of Sale and Assignment of Assets, dated as of
the Closing Date and executed by Seller, in the form attached hereto as Exhibit C.
“Books and Records” shall have the meaning set forth in Section 2.01(d).
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
“Business” means the manufacturing, warehousing, testing and other operations
conducted as of the date hereof by or on behalf of Seller or any of its Affiliates, in each case
with respect to the Product in the Territory.
“Buyer” shall have the meaning set forth in the Preamble.
“Buyer Confidential Information” shall have the meaning set forth in
Section 6.03(c)
“Buyer Indemnified Parties” shall have the meaning set forth in Section 9.02.
“Catalent Facility” shall mean the manufacturing facility of Catalent Pharma
Solutions, Inc. located at 0000 Xxx Xxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000.
“Change of Control” shall have the meaning set forth in Section 6.02(e)
“Closing” shall have the meaning set forth in Section 8.01.
“Closing Date” shall have the meaning set forth in Section 8.01.
“Competing Product” shall have the meaning set forth in Section 6.02(a).
“Confidentiality Agreement” shall have the meaning set forth in
Section 6.03(a).
“Contract” shall mean any agreement, contract, lease, consensual obligation, promise,
or undertaking (whether written or oral and whether express or implied), whether or not legally
binding.
“Copyrights” shall mean all registered and unregistered copyrights in both published
works and unpublished works that relate primarily to the Product or that are used in connection
with the operation of the Business.
“Direct Claim” shall have the meaning set forth in Section 9.05(e).
“Encumbrances” means any charge, claim, community property interest, condition,
equitable interest, lien (statutory or otherwise), option, pledge, security interest, mortgage,
right of way, easement, encroachment, servitude, right of first option, right of first refusal or
similar restriction, including any restriction on use, voting (in the case of any security or
equity interest), transfer, exercise of any other attribute of ownership, financing statement or
similar encumbrance of any kind or nature whatsoever (including any conditional sale or other title
retention agreement and any lease having substantially the same effect as any of the foregoing and
any assignment or deposit arrangement in the nature of a security device); provided,
however, that Encumbrance(s) shall not include any restrictions on the Assets arising
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
pursuant to and in accordance with the following: (i) the License Agreement; (ii) Seller’s right
to use the Assets under the terms of the Supply Agreement; or (iii) that certain [* * *]
“Esprit” shall have the meaning set forth in the Recitals.
“Esprit License Agreement” mean the License Agreement dated October 18, 2005, between
Novavax and Esprit, and all amendments thereto.
“Excluded Assets” shall have the meaning set forth in Section 2.02(a).
“Excluded Liabilities” shall have the meaning set forth in Section 2.03.
“FDA” shall mean the Food and Drug Administration.
“FDCA” means the United States Federal Food, Drug and Cosmetic Act, as amended, and
the regulations thereunder.
“Formulae” shall mean the percentages and specifications of ingredients used to
manufacture a pharmaceutical product.
“GAAP” means generally accepted accounting principles consistently applied for the
periods involved.
“Governmental Authority” means any agency, board, bureau, court, commission,
department, instrumentality or administration of the United States government, any state
government, any local government, any provincial government or other governmental body or
instrumentality having jurisdiction in the Territory.
“Indemnified Party” and “Indemnifying Party” shall have the respective
meanings set forth in Section 9.05(a).
“Indemnity Cap” shall have the meaning set forth in Section 9.04(b).
“Intellectual Property” shall mean any or all of the following and all rights in,
arising out of, or associated therewith: (i) all United States and foreign patents and utility
models and applications therefor and all reissues, divisions, re-examinations, renewals,
extensions, provisionals, continuations and continuations-in-part thereof, and equivalent or
similar rights anywhere in the world in inventions and discoveries including invention disclosures;
(ii) all trade secrets and other rights in know-how and confidential or proprietary information;
(iii) all copyrights, copyrights registrations and applications therefor and all other rights
corresponding thereto throughout the world; (iv) all industrial designs and any registrations and
applications therefor throughout the world; (v) all rights in world wide web addresses and domain
names and applications and registrations therefor; (vi) all trade names, logos, common law
trademarks and service marks, trademark and service xxxx registrations and applications therefor
and all goodwill associated therewith throughout the world; (vii) any
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
similar, corresponding or
equivalent rights to any of the foregoing anywhere; and (viii) all rights to xxx or recover and
retain damages and costs and attorneys’ fees for past, present and future infringement or breach of
any of the foregoing.
“Know-How” means any proprietary or nonproprietary information related to the
manufacture, preparation, development (both research and clinical), or commercialization of a
product, including product specifications, processes, product designs, plans, trade secrets, ideas,
concepts, inventions, formulae, chemical, pharmacological, toxicological, pharmaceutical, physical,
analytical, stability, safety, quality assurance, quality control and clinical data or information,
technical information, research records or information, and all other confidential or proprietary
technical and business information, whether or not embodied in any documentation or other tangible
materials.
“Labeling” shall be as defined in Section 201(m) of the FDCA, 21 U.S.C. § 321(m),
including the applicable Product’s label, packaging and package inserts accompanying such Product,
and any other written, printed, or graphic materials accompanying such Product, including patient
instructions or patient indication guides.
“Law(s)” means any federal, state or local law, statute, code, ordinance, regulation,
order, writ, injunction, judgment or decree applicable to the specified Person and to the
businesses and assets thereof.
“License Agreement” means the License Agreement dated as of the date hereof between
Buyer and Seller.
“Liabilities” means, as to any Person, all debts, adverse claims, commitments,
liabilities and obligations, direct, indirect, absolute or contingent of such Person, whether
accrued, vested or otherwise, whether in contract, tort, strict liability or otherwise and whether
or not actually reflected, or required by GAAP to be reflected, in such Person’s balance sheets or
other books and records.
“Losses” means any liabilities, demands, claims, actions, causes of action, third
party out of pocket costs and other reasonable costs, damages, deficiencies, Taxes, penalties,
fines, judgments, settlements, arbitrations, assessments, obligations (including those arising out
of any action, such as any settlement or compromise thereof of judgment or award therein or other
loss or expense, whether or not arising out of a third party claim, including all interest,
penalties, reasonably attorneys’ fees and expenses, reasonable accountants’ fees and expenses and
all amounts paid or incurred in connection with any such action, demand, proceeding, investigation,
preservation or enforcement of rights to indemnification), or claim (including any Governmental
Authority or any department, agency or political subdivision thereof) and the investigation,
defense or settlement of any of the foregoing.
“Manufacturing Equipment” shall have the meaning set forth in Section 2.01(e).
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
“Material Adverse Change” means any effect that is, or is likely to be, materially
adverse to the Business taken as a whole; provided, however, that none of the following shall be
deemed, either alone or in combination, to constitute, and none of the following shall be taken
into account in determining whether there has been, a Material Adverse Change: any failure to meet
internal or other estimates, predictions, projections or forecasts of financial performance, or to
achieve any forecasted, projected or planned milestones; any
adverse effect (including any claim, litigation, cancellation of or delay in customer orders,
reduction in revenues or income, disruption of business relationships or loss of employees) arising
from or attributable or relating to the announcement of the transactions contemplated by this
Agreement; conditions affecting any of the industries in which Buyer operates or participates, or
the U.S. economy or financial markets; the taking of any action reasonably required to cause
compliance with the terms of, or the taking of any action required by, this Agreement; or the
success of any product that competes with the Business.
“Marks” shall mean the xxxx Estrasorb® and any other marks relating primarily to the
Product or that are used in connection with the operation of the Business, together with the
goodwill symbolized by such Marks.
“MNP Technology” shall have the meaning set forth in the Recitals.
“Names” means “Novavax, Inc.”, “Novavax”, variations and derivatives thereof and any
other logos or trademarks, trade names or service marks of Seller or its Affiliates not included on
Schedule 2.01(a).
“NDA” means a New Drug Application for any product, as appropriate, requesting
permission to place a drug on the market in accordance with the FDCA, and all supplements or
amendments filed pursuant to the requirements of the FDA, including all documents, data and other
information concerning a product which are reasonably necessary for FDA approval to market a
product in the United States.
“Patents” shall mean the patent described in Schedule 2.01(a), and all other
issued patents (including all reissues, divisions, re-examinations, renewals, extensions,
provisionals, continuations and continuations-in-part thereof, and equivalent or similar rights
anywhere in the world thereof), pending or unfiled patent applications and inventions and
discoveries that may be patentable that relate primarily to the Product or that are used in
connection with the operation of the Business.
“Person” or “person” means any individual, corporation, partnership, limited
liability company, joint venture, trust, unincorporated organization, other form of business or
legal entity or Governmental Authority.
“PHSA” shall mean the Public Health Services Act, as amended, and the regulations
thereunder.
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
“Pre-Closing Receivables” shall have the meaning set forth in
Section 2.02(a)(iii).
“proceeding” shall mean any action, arbitration, audit, hearing, investigation,
litigation, or suit (whether civil, criminal, administrative, judicial or investigative, whether
formal or informal, whether public or private) commenced, brought, conducted, or heard by or
before, or otherwise involving, any Governmental Authority or arbitrator.
“Product” shall have the meaning set forth in the Recitals.
“Product Registrations” shall have the meaning set forth in Section 2.01(c).
“Purchase Price” shall have the meaning set forth in Section 2.04.
“Related Documents” means, collectively, this Agreement, the Supply Agreement, the
License Agreement and the other agreements, documents, instruments and certificates executed and
delivered in connection with the transactions contemplated by this Agreement.
“Schedules” means the disclosure schedules delivered by Seller to Buyer in connection
herewith.
“Seller” shall have the meaning set forth in the Preamble.
“Seller Indemnified Parties” shall have the meaning set forth in Section 9.03.
“Seller’s Tax Returns” means all federal, state, local, foreign and other applicable
Tax returns, declarations of estimated Tax reports required to be filed by Seller (without regard
to extensions of time permitted by law or otherwise).
“Supply Agreement” means the Supply Agreement between Seller and Buyer dated as of the
date hereof.
“Taxes” means all federal, state and local taxes (including income, profit, franchise,
sales, use, real property, personal property, ad valorem, excise, employment, social security and
wage withholding taxes) and installments of estimated taxes, assessments, deficiencies, levies,
imports, duties, license fees, registration fees, withholdings, or other similar charges of every
kind, character or description imposed by any Governmental Authorities.
“Territory” shall mean the United States, Canada and Mexico.
“Threshold Amount” shall have the meaning set forth in Section 9.04(a).
“Trade Secrets” shall mean all Know-How, Formulae, trade secrets, inventions and
discoveries, confidential information, research records, test information, customer lists,
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
software, manufacturing and technical information, data, process technology, plans, drawings and
blue prints owned, used or licensed by Seller or its Affiliates as licensee or licensor that relate
primarily to the Product or that are used in connection with the operation of the Business.
“Trademark Registrations” shall mean all pending trademark and service xxxx
applications and registrations for the Marks in the Territory.
“Transferred Know How” shall have the meaning set forth in Section 2.01(b).
“Transfer Taxes” shall have the meaning set forth in Section 10.03.
“United States” shall mean the fifty states of the United States of America and its
territories and possessions including Puerto Rico, irrespective of its political structure, and the
District of Columbia.