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ASSET PURCHASE AGREEMENT

Asset Purchase Agreement

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This Asset Purchase Agreement involves

NOVAVAX INC

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Title: ASSET PURCHASE AGREEMENT
Governing Law: New York     Date: 2/25/2008
Industry: Biotechnology and Drugs     Law Firm: McDermott Will;Cooley Godward     Sector: Healthcare

ASSET PURCHASE AGREEMENT, Parties: novavax inc
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Exhibit 10.1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ASSET PURCHASE AGREEMENT
           THIS ASSET PURCHASE AGREEMENT (this “ Agreement ”) is entered into as of February 19, 2008, by and between NOVAVAX, INC., a Delaware corporation (“ Seller ”), and GRACEWAY PHARMACEUTICALS, LLC, a Delaware limited liability company (“ Buyer ”). Seller and Buyer are sometimes referred to herein as the “parties” and individually as a “party”.
           WHEREAS , Seller developed a pharmaceutical product known as Estrasorb® (such product, including all dosages and formulations, whether existing on the date hereof or in the past, the “ Product ”), utilizing certain micellar nanoparticle technology owned by Seller and covered in Patent No. 5,629,021 (the “ MNP Technology ”);
           WHEREAS , Seller granted to Allergan USA, Inc. (formerly known as Esprit Pharma, Inc.), a Delaware corporation (“ Esprit ”), an exclusive license to certain rights to manufacture, market, promote and sell the Product in the United States, Mexico and Canada, and subsequently thereafter Seller transferred to Esprit all right, title and interest in and to the NDA (as hereinafter defined) for the Product and other regulatory approvals for the Product;
           WHEREAS , Allergan, Inc., a Delaware corporation (“ Allergan ”), owns, directly or indirectly, all of the outstanding capital stock of Esprit;
           WHEREAS , Seller, collectively with Esprit and certain of Esprit’s affiliates, own all right, title and interest in, to and under all assets, properties, privileges, claims and rights relating to the Product and the MNP Technology in the Territory (as hereinafter defined);
           WHEREAS , concurrently with the execution and delivery of this Agreement, Buyer, Esprit and Allergan have entered into an Asset Purchase Agreement (the “ AGN Asset Purchase Agreement ”), pursuant to which Esprit has agreed to sell to Buyer, and Buyer has agreed to purchase from Esprit, all right, title and interest of Esprit and certain of Esprit’s affiliates in the Territory in and to the assets and rights associated with the Product identified therein, and Allergan has agreed to guaranty the obligations of Esprit thereunder, all on the terms and subject to the conditions set forth in the AGN Asset Purchase Agreement; and
           WHEREAS , Seller desires to sell to Buyer, and Buyer desires to purchase from Seller, all right, title and interest of Seller in the Territory in and to the Product and the MNP Technology, and all privileges, claims and rights relating to the Product, and the MNP Technology and the other assets and rights identified herein, all on the terms and subject to the conditions hereinafter set forth.
           NOW, THEREFORE , in consideration of the foregoing and of the representations, warranties, mutual covenants and agreements hereinafter set forth and intending to be legally bound hereby, the parties hereto agree as follows:

 


 
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 1.
DEFINITIONS AND INTERPRETATIONS
          Capitalized terms used herein without definition shall have the respective meanings assigned thereto in Annex I attached hereto and incorporated herein for all purposes of this Agreement (such definitions to be equally applicable to both the singular and plural forms of the terms defined). Additionally, in this Agreement, unless a clear contrary intention appears: (a) all references herein to “Articles” or “Sections” are to Articles or Sections of this Agreement; (b) the singular number includes the plural number and vice versa ; (c) reference to any agreement, document or instrument means such agreement, document or instrument as amended or modified and in effect from time to time in accordance with the terms thereof; (d) “including” (and with correlative meaning “include”) means including without limiting the generality of any description preceding such term; and (e) references to documents, instruments or agreements shall be deemed to refer as well to all addenda, exhibits, schedules or amendments thereto.
ARTICLE 2.
SALE AND PURCHASE OF ASSETS;
PURCHASE PRICE; EXCLUDED LIABILITIES
      2.01 Sale and Purchase of Assets.
          Subject to the terms and conditions of this Agreement (including Section 2.02 ), at Closing Seller shall sell, assign, transfer, convey and deliver to Buyer, and Buyer shall purchase, acquire, pay for and accept from Seller, all right, title and interest of Seller and its Affiliates in the Territory in, to and under the following assets, properties, privileges, claims and rights (collectively, the “ Assets ”), free and clear of all Encumbrances:
          (a) The Patents, Marks, Trademark Registrations and Copyrights described in Schedule 2.01(a) , and all other Intellectual Property (including Trade Secrets) relating primarily to the Product (all such Assets described in the foregoing clauses, the “ Assigned Intellectual Property ”);
          (b) All Know-How that is (i) primarily related to the Product or the Business, (ii) contained within or comprising the Books and Records or (iii) used, useful or necessary in connection with the manufacture, packaging, labeling or testing of the Product as conducted by Seller or its Affiliates as of the date hereof, or in connection with the use, maintenance or operation of the Manufacturing Equipment by or on behalf of Seller or its Affiliates as of the date hereof, in each case solely for the Territory (except in connection with the exercise of Buyer’s rights in Section 2.01(g) to make or have made the Product outside the Territory) (all such Know-How described in clauses (i), (ii) and (iii), the “ Transferred Know-How ”);

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
          (c) All registrations, applications, approvals, licenses and permits relating to the Assets (including the Product) from the FDA and any other Governmental Authority in the Territory held in the name of Seller or any of Seller’s Affiliates (collectively, the “ Product Registrations ”), including those set forth on Schedule 2.01(c) , and all supplements thereto, whether issued, pending, or in draft form, and all records, reports, data and other information primarily related to the Assets (including the Product) required to be kept under applicable Laws in the Territory and all correspondence to or from all Governmental Authorities in the Territory which relates primarily to the Assets (including the Product);
          (d) All current and archived books, computer data, records, files, documents, information, correspondence and data (audio, visual or print) in Seller’s possession or control to the extent relating primarily to the Assets (including the Product) for the Territory, including in each case as and to the extent relating primarily to the Assets for the Territory, as applicable: research and development reports, studies, pre-clinical and clinical data, research and development data, lists of customers and suppliers of the Product in the Territory, miscellaneous records with respect to customers and supply sources, credit and collection records, adverse experience reports and files and data related thereto and all periodic adverse experience reports, files and data, and all other files, data and records related to pharmacovigilence matters, business development plans, advertising matter, catalogs, correspondence, mailing lists, photographs, sales and distribution materials and records, purchasing materials and records, manufacturing and quality control records and procedures, market materials, marketing and promotional materials, product literature, training materials, sale aids, research data, copies of all files relating to the filing, prosecution, issuance, maintenance, enforcement and/or defense of any Assigned Intellectual Property, master batch records, including change of control history, executed records for all lots, including those expired, product batch records, analytical methods and validation reports with respect to process, equipment and methods, product complaints, stability data and the history thereof, annual reports, annual product reports, FDA and internal audit reports, whether on paper or in electronic format (the “ Books and Records ”);
          (e) The manufacturing equipment and assets listed on Schedule 2.01(e) (the “ Manufacturing Equipment ”), and any warranty rights applicable to such Manufacturing Equipment (to the extent the same are transferable);
          (f) All customer and supplier relationships and goodwill primarily related to the Product;
          (g) All rights to market or have marketed, sell or have sold, promote or have promoted, distribute or have distributed the Product in the Territory, and make or have made the Product in or outside of the Territory, including, to the extent transferable, all rights to reference Drug Master Files and other data for the Product’s active pharmaceutical ingredients;
          (h) All claims, counterclaims, credits, causes of action, rights of recovery and rights of setoff and third party warranties, guaranties and similar contractual rights

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
as to the third parties held by Seller or any Affiliate of Seller to the extent related primarily to the Assets; and
          (i) All other assets, properties, privileges, claims and rights of Seller and its Affiliates relating primarily to the Product or the Business in the Territory (except for Intellectual Property or Know-How, each of which is being sold, assigned, transferred, conveyed and delivered by Seller to Buyer pursuant to the other subparagraphs of this Section 2.01 ).
      2.02 Excluded Assets.
          (a) Notwithstanding anything to the contrary in this Agreement, there shall be excluded from the Assets, and retained by Seller, the following assets (collectively, the “ Excluded Assets ”):
               (i) all cash and cash equivalents owned by Seller;
               (ii) all contracts of insurance and all insurance plans and the assets thereof;
               (iii) all accounts receivable or invoices arising out of the sale of the Product on or prior to 11:59 p.m. (EST) on the Closing Date (“ Pre-Closing Receivables ”);
               (iv) any and all claims of Seller with respect to any Tax refunds;
               (v) all human resources and any other employee related files and records;
               (vi) subject to the license and rights granted to Buyer pursuant to Section 6.04 , all right, title and interests of Seller in and to the Names;
               (vii) all books and records relating to or used in the business of Seller and not primarily relating to the Assets;
               (viii) all assets of the Seller not expressly included within the Assets set forth in Section 2.01 above; and
               (ix) all of the rights of Seller under or pursuant to this Agreement or any other rights in favor of Seller pursuant to the Related Documents.
          (b) Notwithstanding the foregoing, neither Seller nor any of its Affiliates shall retain any interest, royalty or Intellectual Property rights relating to the Assets in the Territory, other than rights to receive cash or cash equivalents in connection with Pre-Closing Receivables, except as expressly set forth in the Related Agreements.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
          (c) For the avoidance of doubt under Section 2.01(b) , Buyer acknowledges that Seller retains the ownership rights in the Know-How for use outside the Territory, including the right to develop, make, have made, use, sell, offer for sale, and import products solely outside the Territory, subject to Buyer’s right in accordance with Section 2.01(g) to make or have made the Product outside of the Territory. Buyer hereby agrees not to assert any ownership right, title or interest in or to the Know-How outside the Territory inconsistent with Buyer’s rights under Section 2.01(b) and the foregoing acknowledgement in this Section 2.02(c) .
      2.03 Excluded Liabilities.
          Notwithstanding anything to the contrary in this Agreement, Buyer shall not assume, and Seller and its Affiliates shall retain, pay, perform and discharge when due, all Liabilities of Seller and its Affiliates arising out of or related to the Product and the Business prior to the Closing Date (collectively, the “ Excluded Liabilities ”), except for any post-Closing Date liabilities expressly agreed to be assumed by Buyer pursuant to this Agreement. The Excluded Liabilities shall include the following:
          (a) account payables and Liabilities of Seller or any of its Affiliates for materials and services with respect to the manufacture of the Product or Inventory prior to the Closing Date;
          (b) any Tax payable with respect to any business, asset, property or operation of Seller or any member of any affiliated group of which Seller is a member (including any Taxes relating to or arising out of the operation of the Business) arising out of, directly or indirectly, the Assets or the ownership, control, lease, or license of any of the Assets for any pre-Closing Tax period, other than any Tax for which Buyer is responsible pursuant to Section 10.03 ;
          (c) any Liability of Seller or any of its Affiliates arising out of or relating to any Excluded Asset or arising out of the operations or conduct by Seller or its Affiliates of any business other than the Business;
          (d) any Liability of Seller or any of its Affiliates arising out of or relating to independent contractors or employees, including any Liability with respect to employment, compensation or benefits (including severance and benefit plans) for the present or future employees of Seller for all employment relating to the Business;
          (e) all Liabilities of Seller and any of its Affiliates arising out of any product liability, patent infringement, breach of warranty or claim for injury to person or property whenever asserted which resulted from the use or misuse of Product sold prior to the Closing Date (including all proceedings relating to any such Liabilities);

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
          (f) all Liabilities of Seller and any of its Affiliates arising out of government seizures, field corrections, withdrawals or recalls of Product sold prior to the Closing Date, whether claimed prior to, on or after the Closing Date;
          (g) all Liabilities of Seller and any of its Affiliates with respect to any litigation or other claims to the extent arising from any event, circumstance or condition occurring or alleged to have occurred prior to the Closing Date;
          (h) all Liabilities of Seller and any of its Affiliates arising out of user or other similar fees payable to the FDA or other Governmental Authority in the Territory to the extent such fees are payable on account of the operation of the Business prior to the Closing Date;
          (i) all Liabilities of Seller and any of its Affiliates arising out of or related to the use, maintenance, occupancy or possession of the Catalent Facility or the Manufacturing Equipment prior to and during the term of the Supply Agreement, and all Liabilities arising out of or related to the cleaning and removal of such Manufacturing Equipment from the Catalent Facility (except for those costs and expenses of Seller to be reimbursed by Buyer pursuant to the Supply Agreement), and the restoration of the Catalent Facility to its prior condition; and
          (j) all other Liabilities of whatever kind and nature, primary or secondary, direct or indirect, absolute or contingent, known or unknown, whether or not accrued, arising out of or relating to, directly or indirectly, the Seller’s operation of the Business prior to the Closing Date or Seller’s ownership of the Assets (including the Product) prior to the Closing Date.
      2.04 Purchase Price.
          For and in consideration of the conveyances and assignments described herein, Buyer agrees to pay to Seller, and Seller agrees to accept from Buyer, an amount equal to [* * *] (the “ Purchase Price ”).
      2.05 Payment at Closing.
          The Purchase Price shall be paid by Buyer to Seller at the Closing by wire transfer of immediately available funds to the account specified by Seller in writing prior to the Closing.
      2.06 Additional Assurances.
          In addition to and without limitation of the obligations of Seller set forth in Section 10.02 , in the event that from and after the Closing Date, Seller or Buyer shall become aware of any Asset that was not transferred to Buyer on the Closing Date, then Seller shall

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
promptly assign, transfer and convey such Asset to Buyer, free and clear of all Encumbrances, pursuant to assignment documentation reasonably satisfactory to Buyer; provided , that nothing in this Section 2.06 shall limit Seller’s right to contest whether an item is an Asset that should have been conveyed to Buyer at Closing.
ARTICLE 3.
REPRESENTATIONS AND WARRANTIES BY SELLER
           Seller represents and warrants to Buyer as follows as of the Closing Date:
      3.01 Organization and Standing.
          Seller is duly organized, validly existing and in good standing under the laws of the State of Delaware and is duly qualified to do business and is in good standing in any jurisdiction where such qualification is necessary. Seller has the corporate power and authority to own, lease and otherwise to hold the Assets, to carry on the Business, and to enter into and perform the terms of this Agreement, the other Related Documents to which it is a party and the transactions contemplated hereby and thereby.
      3.02 Authorization.
          The execution, delivery and performance of this Agreement and of the other Related Documents to which Seller is a party, and the consummation of the transactions contemplated hereby and thereby, have been duly and validly authorized by all necessary corporate actions of Seller (none of which actions has been modified or rescinded and all of which actions are in full force and effect). This Agreement constitutes, and upon execution and delivery each other Related Document to which Seller is a party will constitute, a valid and binding agreement and obligation of Seller, enforceable against Seller in accordance with their respective terms, except as the same may be limited by bankruptcy, insolvency, reorganization, moratorium and other similar laws of general applicability relating to or affecting creditors’ rights generally and by the application of general principles of equity.
      3.03 Consents and Approvals; No Conflicts.
          (a) The execution and delivery of this Agreement and each other Related Document to which Seller is a party, and the performance of the transactions contemplated herein and therein by Seller will not require any consent, approval, authorization or other action by, or, except as set forth on Schedule 3.03 , filing with or notification to, any Governmental Authority or other Person.
          (b) The execution, delivery and performance by Seller of this Agreement and the other Related Documents to which Seller is a party do not and will not (i) conflict with or violate any Law applicable to Seller, the Assets or the Business or by which any

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
of the Assets or the Business is subject or affected, (ii) conflict with or result in any breach of or constitute a default (or an event which with notice or lapse of time or both would become a default) under any Contract to which Seller is a party or by which Seller is bound or to which any of the Assets or the Business is subject or affected, (iii) result in the creation of any Encumbrance upon the Assets, or (iv) conflict with or violate the organizational documents of Seller; except in the case of clause (i) or (ii) where such conflict, violation or breach would not be reasonably be expected to have a material adverse effect on the Assets or the Business.
      3.04 Absence of Certain Changes or Events.
          Since September 1, 2007, there has been no Material Adverse Change in the Business or the Assets (including the Product). Except as set forth in Schedule 3.04 , since September 1, 2007, Seller has conducted the Business in the ordinary course of business consistent with past practice, and Seller has not (a) incurred, or become subject to, any Liability with respect to the Assets, except current Liabilities incurred in the ordinary course of business consistent with past practice; (b) mortgaged, pledged or subjected to any Encumbrance any of the Assets; (c) transferred to any third party any rights under any licenses, sublicenses or other agreements with respect to any Assigned Intellectual Property; (d) sold, exchanged, transferred or otherwise disposed of, or granted any rights or options in or to, any of the Assets, except for the transfer of inventory in the ordinary course of business; or (e) entered into any transactions with respect to the Business other than in the ordinary course of business consistent with past practice.
      3.05 Absence of Litigation.
          Except as set forth on Schedule 3.04 , there is no action, suit, investigation, proceeding, claim, arbitration or litigation pending against the Seller or its Affiliates or, to the knowledge of Seller, threatened against Seller or its Affiliates with respect to the Product.
      3.06 Assets.
          Except for the Excluded Assets, (a) the Assets described in subsections (a) through (l) of Section 2.01 constitute all of the assets, rights and properties of Seller that are sufficient for the operation of the Business by Seller, and (b) to the Seller’s knowledge, the Assets, together with the assets and rights previously sold or licensed by Seller to Esprit, constitute all assets, rights, privileges and claims relating to the Product and the MNP Technology in the Territory. The sale, transfer and assignment of the Assets as contemplated by this Agreement will give Buyer possession of all assets, rights and properties of Seller, taken as a whole, required to operate the Business by Seller. Except as set forth on Schedule 3.06 , Seller is the sole owner of, and has good and valid title to, the Assets free and clear of any Encumbrances. No Asset is subject to any preemptive right, right of first refusal or other right or restriction arising by or through Seller or any of its Affiliates. At the Closing, Buyer shall acquire good title to, and all right, title and interest in and to the Assets, free and clear of all Encumbrances,

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
except for (and specifically excluding) any Encumbrances arising through, at the direction of, or relating to Buyer or its Affiliates.
      3.07 Contracts; Product Registrations.
          Except as set forth on Schedule 3.07 , neither Seller nor any of its Affiliates is a party to or bound by any material Contract primarily relating to the Business or the Assets. Except as set forth on Schedule 2.01(a) or Schedule 2.01(c) , neither Seller nor any of its Affiliates (a) owns or holds any right, title or interest in any registrations, applications, approvals, licenses or permits relating primarily to the Assets (including the Product) from the FDA or any other Governmental Authority in the Territory, or (b) has in the past owned or held any Product Registrations from any Governmental Authority in the Territory, or registered any Intellectual Property with any Governmental Authority in the Territory.
      3.08 Intellectual Property.
          (a) Schedule 2.01(a) contains a complete and accurate listing of the following, listing the status or renewal dates for each: (i) all registered Assigned Intellectual Property, including the registered Marks, Trademark Registrations, Patents and Copyrights; and (ii) all oral and written material Contracts relating to the Assigned Intellectual Property to which Seller is a party or by which Seller is bound. Except as set forth on Schedule 3.08 , Seller has not granted any license of any kind relating to the Assigned Intellectual Property.
          (b) Except as set forth in Schedule 3.08 , Seller is the sole and exclusive owner of, and has good, valid, and enforceable title to, all rights, title, and interest in and to each item of the Assigned Intellectual Property, free and clear of any Encumbrances. Except as set forth in Schedule 3.08 , Seller has the right to make any use desired, without payment to a third party, of all or any part of the Assigned Intellectual Property and the right to convey such Assigned Intellectual Property to Buyer. At the Closing Date, Buyer shall acquire good, valid, and enforceable title to the Assigned Intellectual Property, free and clear of all Encumbrances.
          (c) Except as set forth in Schedule 3.08 , to the knowledge of Seller: (i) the use by Seller of the Transferred Know - How in connection with the Business does not infringe, misappropriate, or violate, with any Intellectual Property right or other proprietary right of any other Person or requires a license under the same; (ii) the Assigned Intellectual Property does not infringe, misappropriate, violate, or conflict with any Intellectual Property right or other proprietary right of any other Person or require a license under the same; (iii) Seller has terminated all licenses, sublicenses or other grant of rights granted or provided by Seller with respect to the Product or the Assigned Intellectual Property to any third party (including the Esprit License Agreement), and there exist no further Liabilities under any such license or sublicense; (iv) Seller is not in breach or default of any license or other grant of rights with respect to the Assigned Intellectual Property, nor is any other Person in breach or default of any such license or grant of rights; (v) there have been no claims made against, or notices received

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
by Seller or any of its Affiliates alleging or asserting the invalidity, misuse or unenforceability of any Assigned Intellectual Property (including any demand or request that Seller cease using any Assigned Intellectual Property or license any Intellectual Property from any third party); and (vi) neither Seller nor any of its Affiliates have taken any action, or failed to take any action, used or enforced or failed to use or enforce any of the Assigned Intellectual Property in a manner that would result in the abandonment, cancellation, forfeiture, relinquishment, or unenforceability of any of the Assigned Intellectual Property, or any registration therefor, or any of Seller’s rights therein.
          (d) Any Assigned Intellectual Property that has been duly registered with or filed in the U.S. Patent and Trademark Office or the U.S. Copyright Office or other applicable Governmental Authority is identified on Schedule 2.01(a) , and all such registrations are currently in compliance with all formal legal requirements; provided , however , that Copyrights have not been registered with the U.S. Copyright Office or otherwise been registered with any Governmental Authority. To Seller’s knowledge, Seller has taken all commercially reasonable and desirable actions consistent with its past practice to maintain and protect the Assigned Intellectual Property owned by Seller and no loss or expiration of any such Assigned Intellectual Property is pending or threatened.
      3.09 Compliance with Law.
          (a) All of Seller’s manufacture, packaging, labeling, testing for release and sale of Product has been in compliance with all applicable requirements under FDCA, PHSA, and similar Laws, rules and regulations relating to investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, record keeping, filing of reports, including adverse event reports as required by 21 C.F.R. Section 314.80.
          (b) Seller has obtained all applicable material approvals, clearances, authorizations, licenses and registrations required by the United States, any other Governmental Authority, or foreign governments or government agencies, to permit the operation of the Business, and Seller is in material compliance with all reporting requirements relevant thereto.
          (c) To Seller’s knowledge, the NDA held by Allergan for the Product is in full force and effect.
          (d) With respect to the Product, neither Seller nor any of its Affiliates is in violation of and Seller and its Affiliates are in compliance with, all applicable registration and listing requirements set forth in 21 U.S.C. § 360 and 21 C.F.R. Part 207, in each case as applicable to Seller’s conduct of the Business.
          (e) All manufacturing, warehousing, distributing, and testing operations conducted by Seller or any of its Affiliates or, to the Seller’s knowledge, for the benefit of Seller or any of its Affiliates with respect to the Product in the Territory are not in violation of and have

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
been and are being conducted in material compliance with, the good manufacturing practice regulations set forth in 21 C.F.R. Parts 210 and 211.
          (f) With respect to the Product in the Territory, neither Seller, any of its Affiliates or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in Compliance Policy Guide sec. 120.100 (7150.09) (issued September 1, 1991) and any amendments thereto.
          (g) With respect to the Product in the Territory or to the facilities in which the Product has been developed, manufactured, packaged, collected, handled or stored by or on behalf of Seller, no written reports of inspection observations (FDA Form 483), establishment inspection reports, warning letters or other documents have been received by Seller from by the FDA or other regulating agencies within the last three (3) years that allege lack of compliance with applicable regulatory requirements by Seller, its Affiliates, or, to the knowledge of Seller, Persons covered by product applications or otherwise performing services for the benefit of Seller or its Affiliates.
          (h) Seller has made available to Buyer copies of all written communications to the FDA from Seller or received by Seller from the FDA relating specifically to the Product in the Territory, and Seller’s operations or business, including any deficiency letter, warning letter, non-approvable letter/order, withdrawal letter/order and correspondence bearing on the safety and efficacy of the Product.
          (i) Neither Seller nor any of its Affiliates have received any written notice and have no knowledge that the FDA, or any other regulating agency, has commenced or threatened to initiate, any action seeking the withdrawal, recall, suspension, or seizure of the Product in the Territory, or commenced or threatened to initiate, any action to enjoin production at any facility where the Product has been manufactured.
          (j) As to each article of drug or consumer product manufactured or distributed by Seller or on behalf of Seller or any of its Affiliates with respect to the Product in the Territory, such article is not adulterated or misbranded within the meaning of the FDCA, 21 U.S.C. §§ 351, 352 et. seq., and all Labeling of Seller or its Affiliates with respect to the Product are otherwise in conformance with applicable regulations.
          (k) With respect to the Product, Seller, its Affiliates and their respective officers, employees, agents and affiliates have included or caused to be included in the application for any drug, where required, the certification described in 21 U.S.C. §335a(k)(l) and the list described in 21 U.S.C. § 335a(k)(2), and such certification and such list was in each case

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
true and accurate, in all material respects, when made and remained true and accurate in all material respects thereafter.
          (l) To the knowledge of Seller, with respect to the Product, contractors of Seller and its Affiliates are in compliance with all applicable Laws and, in respect of the FDA, have secured all licenses and renewals necessary to their operation.
          (m) As to each commercial or investigational application or abbreviated application submitted by Seller or any of its Affiliates for the Product to, but not authorized or approved by, the FDA, and not withdrawn by Seller or any of its Affiliates, or applicants acting on their behalf as of the date of this Agreement, Seller and its Affiliates have complied and are in compliance with, the requirements of 21 U.S.C. §§ 355 and 21 C.F.R. Parts 312 and 314 and have provided all additional information and taken all additional action reasonably requested by the FDA in connection with the application.
          (n) To Seller’s knowledge, there are no lawsuits, actions, arbitrations or legal or administrative or regulatory proceedings, charges, complaints, or investigations by the FDA or any other Governmental Authority pending against Seller or its Affiliates with respect to any approved application, license, or registration for the Product. To the knowledge of Seller, there are no proceedings pending with respect to a violation by Seller or its Affiliates of the FDCA, or PHSA, FDA regulations adopted thereunder, or any other legislation or regulation promulgated by any other Governmental Authority which might result in the revocation, cancellation, suspension, limitation or adverse modification of any approved application, license, or registration with respect to the Product.
          (o) Neither Seller nor its Affiliates have been served with any complaint or received any other notices of lawsuits, arbitrations, legal or administrative or regulatory proceedings, charges, complaints or investigations by any federal, state or foreign regulatory agency threatened or pending against or relating to Seller or its Affiliates or any approved application, license, or registration of Seller or its Affiliates with respect to the Product. There have been no product recalls, withdrawals, suspensions, discontinuations, or similar actions by Seller or any of its Affiliates (whether voluntary or otherwise) with respect to the Product.
          (p) To the knowledge of Seller, no Person has filed a claim for loss or potential loss under any indemnity covering participants in clinical trials of the Product.
          (q) To the knowledge of Seller, all regulatory-related information with respect to the manufacturing of the Product disclosed to Buyer by Seller or any of its Affiliates is true and accurate in all material respects and to the Seller’s knowledge, no information has been omitted from such disclosures to Buyer that is required to make the information actually disclosed to Buyer materially complete or not materially misleading.
          (r) [* * *]

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
      3.10 Condition of Manufacturing Equipment.
          The Manufacturing Equipment is free from material defect, in good operating condition and repair (ordinary wear and tear excepted), has been maintained in accordance with normal industry practice, and is suitable and adequate for the uses to which it is being put, and, to the knowledge of Seller, none of the Manufacturing Equipment is in need of maintenance or repairs, except for ordinary, routine maintenance and repairs that are not material in nature or cost. The Manufacturing Equipment is sufficient for the continued conduct of the Business from and after the Closing Date in substantially the same manner as conducted prior to the Closing, subject to replacement for wear and tear obsolescence, provided that Seller makes no representation or warranty with regard to Buyer’s ability to continued manufacture of the Product with sufficient quality or quantities in respect of the operation of the Business by Buyer.
      3.11 Inventory.
          Seller does not have any right, title or interest in any existing raw materials, inventories of active pharmaceutical ingredients for the Product, components, works-in-process or finished goods inventory of the Product.
      3.12 Brokers.
          Except as set forth on Schedule 3.12 , neither Seller nor any Affiliate of Seller has engaged, or incurred any unpaid liability for any brokerage fees, finders’ fees, commissions or otherwise to any broker, finder or agent in connection with the transactions contemplated by this Agreement.
      3.13 Suppliers.
          Seller and its Affiliates have used reasonable business efforts to maintain, and currently maintain, good working relationships with all of its suppliers that supply products or services for the Business, including clinical research organizations providing services to Seller. There have been no material adverse changes in the relationships during the past twelve (12) months between Seller and such suppliers, including clinical research organizations providing services to Seller. Schedule 3.13 specifies for the period beginning January 1, 2007 to the date of this Agreement the names of the suppliers of the Product, suppliers of active pharmaceutical ingredients to Seller and any clinical research organization providing services to Seller that are material to the Business. None of the suppliers or clinical research organizations set forth in Schedule 3.13 has given Seller or any of its Affiliates notice terminating, canceling or threatening to terminate or cancel any contract or relationship with Seller or any of its Affiliates relating to the manufacture of the Product by Seller.

- 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.
      3.14 Solvency.
          (a) The Purchase Price represents reasonably equivalent value for the Assets.
          (b) Seller is acting in good faith and has no reason to believe that Buyer is purchasing the Assets other than in good faith.
          (c) Seller is not entering into the Agreement with the intent to hinder, delay or defraud any Person to which it is or may become indebted.
          (d) Seller (i) is not currently debtor or alleged debtor in a case filed under the United States Bankruptcy Code, Title 11 U.S.C., as amended (the “ Bankruptcy Code ”), (ii) is not the subject of a receivership proceeding under any state law, (iii) is not a party in any case providing for a collective remedy among Seller’s creditors generally, (iv) is not the subject of a present threat by another person or entity to commence any of the foregoing proceedings against Seller, and (v) has no present intention to commence any such proceeding on their own behalf.
          (e) As of the date of this Agreement, Seller is, and as of the Closing Date and immediately after the Closing Date, Seller will be, not “insolvent,” as that term is defined in the text and interpretive case law of the Bankruptcy Code.
          (f) As of the Closing Date, Seller is, and immediately after the Closing Date Seller will be, able to pay its Liabilities as they mature.
ARTICLE 4.
REPRESENTATIONS AND WARRANTIES BY BUYER
          Buyer represents and warrants to Seller as follows as of the Closing Date:
      4.01 Organization and Standing.
          Buyer is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware and is duly qualified to do business in each jurisdiction where such qualification is necessary. Buyer has the full power and authority to enter into and perform the terms of this Agreement and the other Related Documents to which it is a party and to carry out the transactions contemplated hereby and thereby.
      4.02 Authorization.
          The execution, delivery and performance of this Agreement and of the other Related Documents to which Buyer is a party, and the consummation of the transactions contemplated hereby and thereby, have been duly and validly authorized by all necessary actions

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
of Buyer (none of which actions has been modified or rescinded and all of which actions are in full force and effect). This Agreement constitutes, and upon execution and delivery each such other Related Document to which Buyer is a party will constitute, a valid and binding agreement and obligation of Buyer, enforceable against Buyer in accordance with its respective terms, except as the same may be limited by bankruptcy, insolvency, reorganization, moratorium and other similar laws of general applicability relating to or affecting creditors’ rights generally and by the application of general principles of equity.
      4.03 Consents and Approvals; No Conflicts.
          (a) The execution and delivery of this Agreement and the other Related Documents to which Buyer is a party, and the performance of the transactions contemplated herein by Buyer, will not require any consent, approval, authorization or other action by, or filing with or notification to, any Governmental Authority or other Person which has not already been obtained.
          (b) The execution, delivery and performance by Buyer of this Agreement and the other Related Documents to which Buyer is a party do not and will not (i) conflict with or violate any Law applicable to Buyer, (ii) conflict with or result in any breach of or constitute a default (or an event which with notice or lapse of time or both would become a default) of any Contract to which Buyer is a party or by which Buyer is bound, or (iii) conflict with or violate the organizational documents of Buyer.
      4.04 Brokers.
          Except for Wachovia Securities, Buyer has not engaged, or incurred any unpaid liability (for any brokerage fees, finders’ fees, commissions or otherwise) to any broker, finder or agent in connection with the transactions contemplated by this Agreement. Buyer agrees to indemnify Seller (without limitation), against any claims asserted against Seller for any such fees or commissions by any Person purporting to act or to have acted for or on behalf of Buyer. Notwithstanding any other provision of this Agreement, this representation and warranty shall survive the Closing Date without limitation.
ARTICLE 5.
REGULATORY MATTERS
      5.01 Regulatory Filings.
          From and after the Closing Date, to the extent necessary under applicable Law, each of the parties hereto shall continue to use all commercially reasonable efforts to take, or cause to be taken, all appropriate action, and do, or cause to be done, all things necessary, proper or advisable under applicable Laws or otherwise to make effective the transactions contemplated

- 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.
by this Agreement as promptly as practicable, including, using all its commercially reasonable efforts to transfer and obtain all licenses, permits, consents, approvals, authorizations, qualifications and orders of Governmental Authorities as are necessary.
      5.02 Responsibility for the Product.
          (a) Subject to the Supply Agreement, from and after the Closing Date, Buyer shall assume all regulatory responsibilities permitted by applicable Laws to be assumed by Buyer, reporting and otherwise, in connection with the Product, the Product Registrations, to the extent related to the period from and after the Closing Date, including responsibility for reporting any adverse drug experiences in connection with the Product in or with respect to the Territory, and responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time.
          (b) Seller and its Affiliates shall promptly submit to Buyer all written medical i

 
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