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ASSET PURCHASE AGREEMENT

Asset Purchase Agreement

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IMARX THERAPEUTICS INC | MICROBIX BIOSYSTEMS INC

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Title: ASSET PURCHASE AGREEMENT
Governing Law: Delaware     Date: 9/26/2008
Industry: Biotechnology and Drugs     Law Firm: DLA Piper;Foley Lardner     Sector: Healthcare

ASSET PURCHASE AGREEMENT, Parties: imarx therapeutics inc , microbix biosystems inc
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Exhibit 10.1

 

ASSET PURCHASE AGREEMENT

dated as of September __, 2008

by and between

IMARX THERAPEUTICS, INC.

(“Seller”)

and

MICROBIX BIOSYSTEMS INC.

(“Buyer”)

 

 

 


 

TABLE OF CONTENTS

 

 

 

 

 

 

 

PAGE

 

 

 

 

 

 

ARTICLE 1 Definitions

 

 

1

 

1.1 Definitions

 

 

1

 

 

 

 

 

 

ARTICLE 2 Purchase and Sale

 

 

5

 

2.1 Agreements to Purchase and Sell

 

 

5

 

2.2 Excluded Assets

 

 

7

 

2.3 Assumed Liabilities

 

 

8

 

2.4 Excluded Liabilities

 

 

9

 

2.5 Procedures for Purchased Assets not Transferable

 

 

10

 

 

 

 

 

 

ARTICLE 3 Purchase Price; Bonus; Consistent Treatment

 

 

10

 

3.1 Purchase Price and Bonus

 

 

10

 

3.2 Payment of Purchase Price

 

 

10

 

3.3 Prorations

 

 

10

 

 

 

 

 

 

ARTICLE 4 Closing

 

 

11

 

4.1 Closing Date

 

 

11

 

4.2 Transactions at Closing

 

 

11

 

 

 

 

 

 

ARTICLE 5 Representations and Warranties of Seller

 

 

12

 

5.1 Organization

 

 

12

 

5.2 Due Authorization

 

 

13

 

5.3 Inventory, Equipment and Raw Materials

 

 

13

 

5.4 Title

 

 

13

 

5.5 Intellectual Property

 

 

14

 

5.6 Litigation

 

 

14

 

5.7 Consents

 

 

14

 

5.8 Brokers, Etc.

 

 

14

 

5.9 Absence of Undisclosed Liabilities

 

 

14

 

5.10 Governmental Authorizations

 

 

14

 

5.11 Contracts

 

 

14

 

5.12 Tax Matters

 

 

15

 

5.13 Cell Banks

 

 

15

 

5.14 Environmental Matters

 

 

16

 

5.15 Chargebacks

 

 

16

 

5.16 Regulatory Compliance

 

 

16

 

5.17 Disclaimer

 

 

16

 

 

 

 

 

 

ARTICLE 6 Representations and Warranties of Buyer

 

 

17

 

6.1 Organization

 

 

17

 

6.2 Due Authorization

 

 

17

 

6.3 Consents

 

 

17

 

6.4 Litigation

 

 

17

 

6.5 Breach of Representations and Warranties

 

 

17

 

6.6 Brokers, Etc.

 

 

17

 

6.7 Independent Investigation

 

 

18

 

 

i


 

TABLE OF CONTENTS

 

 

 

 

 

 

 

PAGE

 

 

 

 

 

 

ARTICLE 7 Pre-Closing Covenants of Seller and Buyer

 

 

18

 

7.1 Corporate and Other Actions

 

 

18

 

7.2 Consents and Approvals

 

 

18

 

7.3 Access to Information

 

 

18

 

7.4 Ordinary Course of Business

 

 

18

 

 

 

 

 

 

ARTICLE 8 Conditions

 

 

19

 

8.1 Conditions to Obligations of Seller

 

 

19

 

8.2 Conditions to Obligations of Buyer

 

 

20

 

8.3 Seller’s Remedy

 

 

21

 

 

 

 

 

 

ARTICLE 9 Post-Closing Covenants, Other Agreements

 

 

21

 

9.1 Availability of Records

 

 

21

 

9.2 Use of Trade or Service Marks

 

 

21

 

9.3 Tax Matters

 

 

22

 

9.4 Regulatory Transfer

 

 

22

 

9.5 Post-Closing Delivery

 

 

22

 

9.6 Transition Services

 

 

22

 

9.7 Preparation of 2008 Annual Report

 

 

23

 

9.8 No Other Compensation

 

 

23

 

 

 

 

 

 

ARTICLE 10 Indemnification and Survival

 

 

23

 

10.1 Indemnification by Seller

 

 

23

 

10.2 Indemnification by Buyer

 

 

24

 

10.3 Survival

 

 

25

 

10.4 Exclusive Remedy

 

 

25

 

10.5 Net Losses and Subrogation

 

 

26

 

10.6 Insurance

 

 

26

 

 

 

 

 

 

ARTICLE 11 Termination

 

 

27

 

11.1 Termination of Agreement

 

 

27

 

11.2 Automatic Termination

 

 

27

 

11.3 Continuing Effectiveness

 

 

27

 

 

 

 

 

 

ARTICLE 12 Miscellaneous

 

 

27

 

12.1 Assignment

 

 

27

 

12.2 No Press Release Without Consent

 

 

27

 

12.3 Confidentiality

 

 

28

 

12.4 Expenses

 

 

28

 

12.5 Severability

 

 

28

 

12.6 Entire Agreement

 

 

28

 

12.7 No Third Party Beneficiaries

 

 

28

 

12.8 Waiver

 

 

29

 

12.9 Governing Law

 

 

29

 

12.10 Headings

 

 

29

 

12.11 Counterparts

 

 

29

 

12.12 Further Documents

 

 

29

 

12.13 Notices

 

 

29

 

12.14 Schedules

 

 

30

 

12.15 Construction

 

 

31

 

 

ii


 

Exhibits and Schedules

 

 

 

Exhibits

 

 

 

 

 

Exhibit A – Assignment and Assumption Agreement

 

 

Exhibit B – Intellectual Property Transfer Agreement

 

 

Exhibit C – Testing Procedures

 

 

Exhibit D – Form of Opinion of Seller’s Counsel

 

 

Exhibit E – Copy of the Notification of Transfer of Ownership directed to the FDA

 

 

Exhibit F – Copy of the Seller Insurance Policies

 

 

Exhibit G – Inventory Trademark License Agreement

 

 

 

 

 

Schedules

 

 

 

 

 

Schedule 1.1 – Persons

 

 

Schedule 2.1(a) – Sales Materials

 

 

Schedule 2.1(b) – Transferred Intellectual Property

 

 

Schedule 2.1(c) – Cell Banks

 

 

Schedule 2.1(d)(i) – Assumed Contracts

 

 

Schedule 2.1(d)(ii) – Assumed Liability Contracts

 

 

Schedule 2.1(e) – Other Inventory

 

 

Schedule 2.1(g) – Seller Labeled Inventory

 

 

Schedule 2.1(h) – Seller Unlabeled Inventory

 

 

Schedule 2.1(i) – Product Information

 

 

Schedule 2.1(j) – Product Applications

 

 

Schedule 2.1(l) – Raw Materials

 

 

Schedule 2.1(m) – Product Stability Samples

 

 

Schedule 2.1(n) – Equipment

 

 

Schedule 2.3(b) – Channel Inventory

 

 

Schedule 3.3 – Prorated Items

 

 

Schedule 4.2(d) – Notification Contracts

 

 

Schedule 5.4 – Title

 

 

Schedule 5.5 – Intellectual Property

 

 

Schedule 5.6 – Litigation

 

 

Schedule 5.7 – Seller Consents

 

 

Schedule 5.10 - Governmental Authorizations

 

 

Schedule 5.14 – Environmental Matters

 

 

Schedule 5.16 – Regulatory Compliance

 

 

Schedule 6.3 – Buyer Consents

 

 

 

iii


 

ASSET PURCHASE AGREEMENT

THIS AGREEMENT, dated as of September  _____, 2008 is entered into by and between IMARX THERAPEUTICS, INC., a Delaware corporation (“ Seller ”), and MICROBIX BIOSYSTEMS INC., a Canadian corporation (“ Buyer ”).

WHEREAS, Seller wishes to sell to Buyer the Purchased Assets and Assumed Liabilities (each as defined below), and Buyer wishes to purchase such assets from Seller and to assume such liabilities.

NOW, THEREFORE, in consideration of the premises and mutual covenants, agreements and provisions herein contained, the parties hereto agree as follows:

ARTICLE 1

Definitions

1.1 Definitions . The following terms have the following meanings when used herein:

$ ” means United States dollars.

Affiliate ” shall mean a Person that directly, or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with, the Person specified. For purposes of this definition, the terms “control,” “controlled by” and “under common control with” shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such Person and, in the case of an entity, shall require (i) in the case of a corporate entity, direct or indirect ownership of at least a majority of the securities having the right to vote for the election of directors, and (ii) in the case of a non-corporate entity, direct or indirect ownership of at least a majority of the equity interests with the power to direct the management and policies of such non-corporate entity.

Agreement ” means this Asset Purchase Agreement, including all Schedules and Exhibits hereto, as it may be amended from time to time in accordance with its terms.

Assignment and Assumption Agreement ” means the Assignment and Assumption Agreement and Bill of Sale in substantially the form attached hereto as Exhibit A .

Assumed Contracts ” has the meaning set forth in Section 2.1(d)(i) .

Assumed Liabilities ” has the meaning set forth in Section 2.3 .

Assumed Liability Contracts ” has the meaning set forth in Section 2.1(d)(ii) .

Bonus ” has the meaning set forth in Section 3.1 .

Buyer ” has the meaning set forth in the preamble hereto.

Cell Banks ” has the meaning set forth in Section 2.1(c) .

 

 


 

cGMP ” means the current Good Manufacturing Practice requirements promulgated under section 520 of the FDCA.

Channel Inventory ” has the meaning set forth in Section 2.2(e) .

Chargeback ” means all credits, chargebacks, rebates, reimbursements, refund payments or replacement for returns, administrative fees, and other amounts owed to wholesalers, insurers, distributors, group purchasing organizations, insurers, and other institutions pursuant to any Assumed Liability Contract.

Closing ” means the closing of the purchase and sale of the Purchased Assets and assumption of the Assumed Liabilities contemplated by this Agreement.

Closing Date ” means the date set forth in Section 4.1 .

Confidential Information ” has the meaning set forth in Section 12.3 .

Contracts ” means the Assumed Contracts and the Assumed Liability Contracts, collectively.

Disclosure Schedules ” shall mean the schedules attached hereto.

Encumbrance ” shall mean any interest, consensual or otherwise, in property, whether real, personal or mixed property or assets, tangible or intangible, securing an obligation owed to, or a claim by a third Person, or otherwise evidencing an interest of a Person other than the owner of the property, whether such interest is based on common law, statute or contract, and including, but not limited to, any security interest, security title or lien arising from a mortgage, recordation of abstract of judgment, deed of trust, deed to secure debt, encumbrance, restriction, charge, covenant, restriction, claim, exception, encroachment, easement, right of way, license, permit, pledge, conditional sale, option trust (constructive or otherwise) or trust receipt or a lease, consignment or bailment for security purposes and other title exceptions and encumbrances affecting the property.

Environmental Laws ” shall mean any legal requirement relating to: (i) the protection or restoration of the environment, health, or natural resources, (ii) the handling, use, presence, disposal, release or threatened release of any Hazardous Substance or (iii) wetlands, indoor air, pollution, contamination or any injury or threat of injury to persons or property in connection with any Hazardous Substance.

Equipment ” has the meaning set out in Section 2.1(n) .

Excluded Assets ” has the meaning set out in Section 2.2 .

Excluded Liabilities ” has the meaning set forth in Section 2.4 .

FDA ” means the U.S. Food and Drug Administration.

FDCA ” means the Federal Food, Drug and Cosmetic Act of 1938, as amended.

 

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Governmental Authorizations ” has the meaning set forth in Section 2.1(f) .

Hazardous Substance ” shall mean any substance that is (i) listed, classified or regulated pursuant to any Environmental Law, or (ii) any petroleum product or by-product, asbestos-containing material, polychlorinated biphenyls, radioactive materials or radon.

IND 1444 ” means the investigational new drug application, numbered 1,444, filed with the FDA.

Indemnified Person ” has the meaning set forth in Section 10.5(a) .

Indemnifying Person ” has the meaning set forth in Section 10.5(a) .

Intellectual Property Rights ” means all intellectual property, industrial and other proprietary rights, protected or protectable, under the laws of the United States or any other country, or any political subdivision thereof, including, without limitation, (i) all trade names, trade dress, trademarks, service marks, logos, brand names and other identifiers; (ii) copyrights, moral rights (including rights of attribution and rights of integrity); (iii) all trade secrets, inventions, discoveries, devices, processes, designs, techniques, ideas, know-how and other confidential or proprietary information, whether or not reduced to practice; (iv) all domestic and foreign patents and the registrations, applications, renewals, extensions, divisional applications and continuations (in whole or in part) thereof; and (v) all goodwill associated therewith and all rights and causes of action for infringement, misappropriation, misuse, dilution or unfair trade practices associated with (i) through (iv) above.

Intellectual Property Transfer Agreement ” means the Intellectual Property Transfer Agreement in substantially the form attached hereto as Exhibit B .

Inventory ” means the Labeled Inventory, Other Inventory and Unlabeled Inventory, collectively.

Inventory Trademark License Agreement ” means the Inventory Trademark License Agreement in substantially the form attached hereto as Exhibit G .

Knowledge ” means, with respect to Seller, the actual knowledge after reasonable inquiry of the persons listed on Schedule 1.1 .

Labeled Inventory ” has the meaning set forth in Section 2.1(g) .

Losses ” has the meaning set forth in Section 10.1(a) .

Master Cell Bank ” means cell suspension of Urokinase Kidney Cells, as described on Schedule 2.1(c) .

NDA 21-846 ” means new drug application 21-846 filed with the FDA, previously assigned the NDA number 76-1021.

 

3


 

Other Agreements ” means, collectively, the Assignment and Assumption Agreement, the Intellectual Property Transfer Agreement and Inventory Trademark License Agreement.

Other Inventory ” has the meaning set forth in Section 2.1(e) .

Person ” means any individual, corporation, partnership, limited partnership, joint venture, limited liability company, trust or unincorporated organization, governmental entity, government or any agency or political subdivision thereof.

Product ” or “ Products ” means Seller’s urokinase product formerly marketed under the brand name Abbokinase ® and as of the date of this Agreement being rebranded under the brand name Kinlytic™.

Product Impact ” has the meaning set forth in Section 5.14 .

Purchase Price ” has the meaning set forth in Section 3.1 .

Purchased Assets ” has the meaning set forth in Section 2.1 .

Raw Materials ” means those raw materials set forth on Schedule 2.1(l) .

Seller ” has the meaning set forth in the preamble hereto.

Seller Insurance Policies ” has the meaning set forth in Section 10.6 hereof.

SNDAs ” means supplemental new drug applications S-076 through S-101 filed with the FDA, where S-101 is pending and addresses the change to expiration date.

Taxes ” shall mean all taxes, charges, fees, duties, levies or other assessments, including, without limitation, income, gross receipts, net proceeds, ad valorem, turnover, real and personal property (tangible and intangible), sales, use, franchise, excise, value added, goods and services, license, payroll, unemployment, environmental, customs duties, capital stock, disability, stamp, leasing, lease, user, transfer, fuel, excess profits, occupational and interest equalization, windfall profits, severance and employees’ income withholding, social security and similar employment taxes or any other taxes imposed by the United States or any other foreign country or by any state, municipality, subdivision or instrumentality of the Unites States or of any other foreign country or by any other tax authority, including all applicable penalties and interest, and such term shall include any interest, penalties or additions to tax attributable to such taxes.

Testing Procedures ” means the procedures set forth on Exhibit C hereto.

Transferred Intellectual Property ” has the meaning set forth in Section 2.1(b) .

United States ” or “ U.S. ” means the United States of America.

Unlabeled Inventory ” has the meaning set forth in Section 2.1(h) .

Working Cell Banks ” means cell suspension subcultured from Urokinase Kidney Cells, Frozen Sub-2, as set forth on Schedule 2.1(c) .

 

4


 

ARTICLE 2

Purchase and Sale

2.1 Agreements to Purchase and Sell . Subject to the terms and conditions contained herein, at the Closing, Seller shall sell, transfer, convey, assign and deliver to Buyer, and Buyer shall purchase and accept from Seller, free and clear from all Encumbrances, all right, title, and interest of Seller in and to all assets related to the Products, including the following (collectively, the “ Purchased Assets ”):

(a) all sales and marketing information, including all customer records and sales history with respect to customers (including invoices), sales and marketing records, price lists, documents, correspondence, studies, reports, and all other books, ledgers, files, and records of every kind, tangible data, customer lists (including appropriate contact information), vendor and supplier lists, service provider lists, promotional literature and advertising materials, catalogs, data and laboratory books, media records, research material, technical information, blueprints, technology, technical designs, drawings, specifications and other product development records (including those relating to development costs) of the Seller, relating to the Products and including but not limited to those related to the Kinlytic™ relaunch ( Schedule 2.1(a) lists some but not all of the materials described in this Section 2.1(a) ) ;

(b) (i) all Intellectual Property Rights related to the Products, including the domain names, domain name registration applications, contents of websites hosted at the aforementioned domain names, copyrights, copyright applications, trademarks, trademark applications, patents and patent applications set forth on Schedule 2.1(b) , (ii) the package designs, labels, logos (whether or not registered) and associated artwork and typeface, trade names, brand names, logos (whether or not registered), certification marks and service marks that are licensed to or owned, used or held for use by the Seller as of the Closing and are related to the Products and (iii) all technical information, references and standards, methodologies, processes, protocols, specifications, techniques, trade secrets and know how, databases and formulas related to the Products and any supporting documentation that are related to the Products (collectively, the “ Transferred Intellectual Property ”);

(c) the Master Cell Bank and Working Cell Banks described on Schedule 2.1(c) (the “ Cell Banks ”);

(d)

(i) all rights and interest of Seller under and to the contracts set forth on Schedule 2.1(d)(i) (the “ Assumed Contracts ”), including any amounts, payments and receipt due under the Assumed Contracts; however, such rights and interest will not include any rights and interest that relate to Products not included in the Inventory;

(ii) any amounts, payments and receipt due under the contracts set forth on Schedule 2.1(d)(ii) (the “ Assumed Liability Contracts ”) that relate to the Channel Inventory;

 

5


 

(e) the drug substances, clinical lots, reference standards, reserve samples, patient samples and other materials stored for the Seller by Fisher BioServices, Inc. in Rockville, MD, Catalent Pharma Solutions in Philadelphia, PA and BioReliance Corporation in Rockville, MD (the “ Other Inventory ”), including the ones identified on Schedule 2.1(e) hereto;

(f) all licenses, approvals, filings, certificates, permits, registrations, rights, franchises, or other evidence of authority issued to Seller or Seller’s Affiliates by a federal, state, local or foreign governmental agency or authority, regardless of jurisdiction, relating to the Products, in each case to the extent assignable, including NDA 21-846, the SNDAs and IND 1444 (the “ Governmental Authorizations ”);

(g) 29,798 vials of labeled Product, further described in Schedule 2.1(g) hereto, comprising the three lots labeled with National Drug Code (NDC) number 24430-1003-1 (Lots 10800Z7, 10761Z7, 10758Z7) that are the subject of the new NDA 21-846 previously submitted to the FDA seeking, among other things, authorization for release of the Product that is the subject matter of such application so that it can be used commercially by the Seller and distributed by the Seller, but which, as of the date of this Agreement, have not been approved for release by the FDA (“ Labeled Inventory ”);

(h) 78,865 vials of unlabelled Product, further described in Schedule 2.1(h) hereto, that have been approved by Seller for distribution, but have not been submitted by Seller for approval by the FDA (“ Unlabeled Inventory ”);

(i) all records, reports and Product information files (including Product development and regulatory history files), in each case relating primarily to the Products, including without limitation the categories of documents identified on Schedule 2.1(i) ;

(j) all current and pending new drug applications, supplemental new drug applications and investigational new drug applications for the Products as set forth on Schedule 2.1(j) ;

(k) all goodwill relating to the Products;

(l) the Raw Materials specified on Schedule 2.1(l) ;

(m) all vials of Products stability samples set forth on Schedule 2.1(m) ;

(n) the equipment set forth on Schedule 2.1(n) (the “ Equipment ”); and

(o) a total of 64 vials of Abbokinase, comprising of (i) 24 vials are in the keeping of Commonwealth Biotechnologies, Inc. on the date hereof and (ii) 40 vials, bearing National Drug Code (NDC) number 0074-6109-05 and belonging to lot numbered 30821Z7, which shall be repurchased by Seller from the three wholesalers AmerisourceBergen Drug Corporation, McKesson Corporation and Cardinal Health on or after the date hereof but prior to the Closing. The Seller shall repurchase at least 10 vials from each aforementioned wholesaler.

 

6


 

2.2 Excluded Assets . Notwithstanding anything to the contrary in this Agreement, Seller shall not sell, transfer or assign, and Buyer shall not purchase or otherwise acquire, the following assets of Seller (such assets being collectively referred to hereinafter as the “ Excluded Assets ”):

(a) all rights of Seller arising under this Agreement, the Other Agreements or from the consummation of the transactions contemplated hereby or thereby;

(b) all rights of Seller arising under any contract other than: (i) the Assumed Contracts, to the extent such rights do not relate to any Products other than those included in the Inventory, and (ii) the right to amounts, payments and receipts due under Assumed Liability Contracts relating to Channel Inventory;

(c) all corporate minute books, stock records and Tax returns (including all work papers relating to such Tax returns) of Seller and such other similar corporate books and records of Seller and Seller’s Affiliates as may exist on the Closing Date;

(d) all Intellectual Property Rights of Seller or Seller’s Affiliates of any kind not listed on Schedule 2.1(b) or referred to in Section 2.1(b) ;

(e) approximately 3,700 vials of labeled Product bearing National Drug Code (NDC) number 0074-6109-05, further specified on Schedule 2.3(b) hereto, which, as of the date of this Agreement, have been sold to drug wholesale distributors and are in the distribution channel (“ Channel Inventory ”);

(f) all rights to refunds of Taxes paid by or on behalf of Seller;

(g) all insurance policies of the Seller and claims thereunder existing at the Closing Date;

(h) the services of any employee of Seller other than as expressly specified herein;

(i) all assets of any employee benefit plan, arrangement, or program maintained or contributed to by Seller;

 

7


 

(j) all assets, tangible or intangible, wherever situated, not expressly included in the Purchased Assets;

(k) all raw materials not listed on Schedule 2.1(l); and

(l) all equipment of Seller other than the Equipment (as set forth on Schedule 2.1(n) ).

2.3 Assumed Liabilities . On the Closing Date, subject to the provisions of Section 2.4 , Buyer shall assume, or shall cause Buyer’s Affiliates to assume:

(a) the following liabilities of Seller relating exclusively to the Purchased Assets:

(i) Subject to the provisions of Section 2.4(f) , all liabilities and all obligations arising after the Closing Date under the Assumed Contracts (to the extent that such liabilities and obligations do not relate to any Products other than those included in the Inventory), the Transferred Intellectual Property and the Governmental Authorizations being transferred from Seller to Buyer hereunder;

(ii) Taxes related to Purchased Assets attributable to any period or partial period beginning after the Closing are the responsibility of Buyer. Anything herein to the contrary notwithstanding, Taxes specified in Section 3.3 and Section 9.3 hereof shall be paid in accordance with the respective provisions of such sections;

(iii) Except as provided in Section 2.4(f) , all liabilities or other claims related to the research, development, marketing, manufacture, distribution, testing, sale or trials of the Products included in the Inventory, that arise from acts performed after the Closing Date; and

(b) the liability of Seller for payment of up to $500,000 for all monthly Chargebacks related to the Channel Inventory bearing National Drug Code (NDC) number 0074-6109-05 as more particularly set forth on Schedule 2.3(b) provided that when there is no longer any Channel Inventory in the sales channel, if Buyer has expended less than $500,000 for the costs described herein then the difference between the total actual costs expended and $500,000 shall be paid to Seller upon the later of (i) the time at which the Bonus shall have become due and payable by Buyer, or (ii) two months after the receipt by Buyer of confirmation in writing from the pertinent wholesale or distributor of the sale or expiration of the last unsold vial comprising the Channel Inventory. The Buyer shall have no obligation to pay the aforementioned costs in excess of $500,000 and any such costs in excess of $500,000 shall be Seller’s liability. Buyer shall provide a detailed report on a monthly basis containing a description of the payments made under this section for the preceding month.

 

8


 

The liabilities assumed pursuant to this Section 2.3 shall collectively be referred to as the “ Assumed Liabilities ”.

2.4 Excluded Liabilities . Neither Buyer nor Buyer’s Affiliates assume nor will they become responsible for any of the liabilities and obligations of Seller (collectively, the “ Excluded Liabilities ”) except for those set out in Section 2.3 . The Excluded Liabilities shall include, without limitation:

(a) all liabilities and obligations of Seller arising under this Agreement, the Other Agreements or from the consummation of the transactions contemplated hereby or thereby;

(b) any liability or obligation of Seller arising under any contract or agreement that is not an Assumed Liability;

(c) all obligations related to employees of Seller;

(d) any and all claims, causes of action, administrative actions, investigations, criminal or civil actions or other litigation relating to the sale, manufacture or use of Products prior to the Closing, including but not limited to the matters set forth on Schedule 5.6 ;

(e) subject to the express provisions of Section 2.3(b) hereof, any and all claims, causes of action, administrative actions, investigations, criminal or civil actions or other litigation relating to the sale, manufacture or use of Channel Inventory, regardless of whether such actions, claims, causes of actions, investigations or other litigation arose before the Closing or arise after the Closing;

(f) any and all claims, causes of action, administrative actions, investigations, criminal or civil actions or other litigation relating to Products sold after Closing to the extent related to Seller’s failure to manufacture the Inventory in compliance with the standards set forth in the specifications in NDA 21-846, the SNDAs and IND 1444; and

(g) all other liabilities of Seller existing at the Closing Date.

 

9


 

2.5 Procedures for Purchased Assets not Transferable . If any property or other rights included in the Purchased Assets are not assignable or transferable either by virtue of the provisions thereof or under applicable law without the consent of some third party or parties, Seller shall use its commercially reasonable efforts to obtain such consents after the execution of this Agreement, but prior to the Closing, and Buyer shall use its commercially reasonable efforts to assist in that endeavor. If any such consent cannot be obtained prior to the Closing and the Closing occurs, this Agreement, the Other Agreements and the related instruments of transfer shall not constitute an assignment or transfer of the Purchased Asset regarding which such consent was not obtained and Buyer shall not assume Seller’s obligations with respect to such Purchased Asset, but Seller shall use its commercially reasonable efforts to obtain such consent as soon as reasonably possible after the Closing or otherwise obtain for Buyer the practical benefit of such property or rights and Buyer shall use its commercially reasonable efforts to assist in that endeavor. For purposes of this Section 2.5 only and not for the purposes of the rest of this Agreement, commercially reasonable efforts for the Buyer shall not include any requirement of either party to expend money, commence any litigation or offer or grant any accommodation (financial or otherwise) to any third party.

ARTICLE 3

Purchase Price; Bonus; Consistent Treatment

3.1 Purchase Price and Bonus . The purchase price (“ Purchase Price ”) for the Purchased Assets shall consist of a payment at Closing in the amount of Two Million U.S. dollars ($2.0 million), subject to the provisions of Section 4.1 , plus the assumption of the Assumed Liabilities. Upon receipt by Buyer from the FDA of written authorization to release the Labeled Inventory, the Buyer shall make a bonus payment of Two Million Five-Hundred Thousand U.S. dollars ($2.5 million) (the “ Bonus ”) within 30 business days of receipt of such authorization.

3.2 Payment of Purchase Price . The Purchase Price shall be paid in accordance with Section 4.2(b) .

3.3 Prorations . Seller and Buyer agree that anything herein to the contrary notwithstanding no items relating to the Purchase Assets shall be prorated, other than those specified on Schedule 3.3 which describes in sufficient detail such prorations.

 

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ARTICLE 4

Closing

4.1 Closing Date . The Closing shall take place on or before September 23, 2008 (such date, the “ Closing Date ”) at a place and location to be agreed upon between Buyer and Seller, subject to the satisfaction or waiver of each of the conditions set forth in Article 8 . The Seller acknowledges previous receipt of payment in the amount of $50,000.00 (the “ Extension Fee”) from Buyer, which amount shall be creditable against the Purchase Price at Closing. In the event the transaction does not close on or before September 23, 2008, Seller shall be entitled to retain the Extension Fee without any obligation to close the transaction after the aforementioned date.

4.2 Transactions at Closing . At the Closing, subject to the terms and conditions hereof:

(a) Transfer of Purchased Assets . Seller shall transfer and convey or cause to be transferred and conveyed to Buyer all of the Purchased Assets and Seller and Buyer shall execute and Seller shall deliver to Buyer each of the Other Agreements and such other good and sufficient instruments of transfer and conveyance as shall be necessary to vest in Buyer title to all of the Purchased Assets or as shall be reasonably requested by the Buyer. The Seller shall also deliver to Buyer the certificate required by Section 8.2(b) and all other documents required to be delivered by Seller at Closing pursuant hereto. Furthermore, the Seller shall deliver or cause to be delivered to the Buyer’s address specified in Section 12.13 all records, reports and Product information files (including Product development and regulatory history files), in each case relating primarily to the Products, including without limitation the ones falling in the categories identified on Schedule 2.1(i) .

(b) Payment of Purchase Price, Assumption of Assumed Liabilities and Buyer’s Closing Deliveries . In consideration for the transfer of the Purchased Assets and other transactions contemplated hereby Buyer shall: (i) pay to Seller on the Closing Date One Million Nine Hundred and Fifty Thousand U.S. dollars ($1,950,000) of the Purchase Price by electronic bank transfer in immediately available funds directly to Seller’s Account for which wiring instructions shall be provided to Buyer by Seller in writing before the Closing; and (ii) execute and deliver to Seller the Assignment and Assumption Agreement, whereby Buyer assumes the Assumed Liabilities, and each of the Other Agreements, as well as the certificate required by Section 8.2(b) and all other documents required to be delivered by Buyer at Closing pursuant hereto.

 

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(c) Regulatory Transfer . At Closing, Seller will provide to Buyer copies of all portions of NDA 21-846, the SNDAs and IND 1444 necessary to allow Buyer to comply with its obligations as the application holder. Seller further agrees to notify the FDA of the transfer of ownership of NDA 21-846, the SNDAs and IND 14444 in accordance with Section 505(j) of the FDCA and 21 CFR 314.72, effective immediately upon the Closing, using the respective forms of notice attached hereto as Exhibit E . Buyer agrees to notify the FDA of the transfers of NDA 21-846, the SNDAs and IND 1444 effective immediately upon the Closing and to submit as the new owner a Form FDA 356h and letter in accordance with 21 CFR 314.72.

(d) Notification of transfer of Purchased Assets . At or before the Closing, Seller will notify all parties to the contracts specified on Schedule 4.2(d) hereto of the transfer of the Purchased Assets to Buyer and provide copies of such notices to Buyer.

ARTICLE 5

Representations and Warranties of Seller

Except as set forth in the Disclosure Schedules, Seller represents and warrants to Buyer as follows:

5.1 Organization . Seller is a corporation duly incorporated and validly existing in good standing under the laws of the State of Delaware, duly qualified to transact business as a foreign corporation in such jurisdictions where the nature of its business makes such qualification necessary, except as to jurisdictions where the failure to qualify would not reasonably be expected to have a material adverse effect on the business of the Seller or the Purchased Assets, and has all requisite corporate power and authority to own, lease and operate the Purchased Assets and to carry on its business, including its business related to the Purchased Assets, as now being conducted.

 

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5.2 Due Authorization . Seller has full corporate power and authority to execute, deliver and perform its obligations under this Agreement and the Other Agreements, and the execution and delivery of this Agreement and the Other Agreements and the performance of all of its obligations hereunder and thereunder has been duly and validly authorized and approved by all necessary corporate action of the Seller, including approval of this Agreement and the Other Agreements by the board of directors of the Seller. The signing, delivery and performance of this Agreement and the Other Agreements by Seller is not prohibited or limited by, and will not result in the breach of or a default under, or conflict with any obligation of Seller with respect to the Purchased Assets under (i) any provision of the Certificate of Incorporation or By-Laws of Seller, (ii) any material agreement or instrument to which Seller is a party or by which it or its properties are bound, (iii) any judgment, order, award, writ, injunction or decree of any court, governmental body or instrumentality, or arbitrator, (iv) any Governmental Authorizations, or (v) any applicable law, statute, ordinance, regulation or rule, and, to Seller’s Knowledge, will not result in the creation or imposition of any Encumbrance on any of the Purchased Assets, except to the extent that any such prohibition, limitation, breach, default or conflict would not reasonably be expected to have a material adverse effect on the Purchased Assets. This Agreement has been, and on the Closing Date the Other Agreements will have been, duly executed and delivered by Seller and constitutes, or, in the case of the Other Agreements, will constitute, the legal, valid and binding obligation of Seller, enforceable against Seller in accordance with their respective terms, except as enforceability may be limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other laws of general application relating to or affecting creditors’ rights generally.

5.3 Inventory, Equipment and Raw Materials . The Raw Materials, references and standards and Equipment transferred pursuant to Section 2.1 are in good condition, except as would not reasonably be expected to have a material adverse effect on such Raw Materials, references and standards or Equipment, respectively. The Inventory is, in all material respects, in good and merchantable condition (it being understood that for purposes of the foregoing representation, the Inventory shall be deemed to be in good and merchantable condition in all material respects unless the aggregate amount arising out of all Losses attributable to all the deficiencies in the Inventory, whether qualitative or quantitative, is greater than $10,000, has been manufactured and stored in compliance with all applicable laws and regulations, including cGMP, and the best practices prevalent in the industry, and conforms to all material Governmental Authorizations; provided, however, that the foregoing representation shall be subject to the Buyer’s compliance with any and all applicable material laws and regulations relating to labeling and packaging of the Inventory.

5.4 Title . The Purchased Assets are owned legally and beneficially by Seller with good and marketable title thereto, free and clear of all Encumbrances. At the Closing, Buyer will receive legal and beneficial title to all of the Purchased Assets, free and clear of all Encumbrances, except for liens for Taxes not yet due and payable and the Assumed Liabilities, and except as set forth on Schedule 5.4 and subject to obtaining any consents of Persons listed on Schedule 5.7 .

 

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5.5 Intellectual Property . Except as set forth on Schedule 5.5 , the Transferred Intellectual Property is owned free and clear of all Encumbrances or has been duly licensed for use by Seller and all pertinent licenses and their respective material terms are set forth on Schedule 5.5 . Except as set forth on Schedule 5.5 , to Seller’s Knowledge, the Transferred Intellectual Property has not been nor is likely to be the subject of any pending adverse claim or any threatened litigation or claim of infringement or misappropriation. Except as set forth on Schedule 5.5 , the Seller has not violated the terms of any license pursuant to which any part of the Transferred Intellectual Property has been licensed by the Seller. To Seller’s Knowledge, except as set forth on Schedule 5.5 , the Transferred Intellectual Property does not materially infringe on any Intellectual Property Rights of any third party.

5.6 Litigation . Except as set forth on Schedule 5.6 , there is no litigation, proceeding, claim or governmental investigation pending or, to Seller’s Knowledge, threatened with respect to Seller or the Products.

5.7 Consents . Except as set forth on Schedule 5.7 , no notice to, filing with, authorization of, exemption by, or consent of any Person is required for Seller to consummate the transactions contemplated hereby.

5.8 Brokers, Etc . No broker or investment banker acting on behalf of Seller or under the authority of Seller is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee directly or indirectly from Seller or Buyer in connection with any of the transactions contemplated herein, other than any fee that is the sole responsibility of Seller.

5.9 Absence of Undisclosed Liabilities . To Seller’s Knowledge, Seller has not incurred any liabilities or obligations with respect to the Purchased Assets (whether accrued, absolute, contingent or otherwise), which continue to be outstanding, except as otherwise expressly disclosed in this Agreement.

5.10 Governmental Authorizations . Schedule 5.10 sets forth a complete list of the Governmental Authorizations. The Governmental Authorizations listed in Schedule 5.10 are all the authorizations required to be in material compliance with all laws applicable to the Purchased Assets and their sale, distribution and marketing in the United States. The Governmental Authorizations are in full force and effect in accordance with their terms, and there have been no material violations of such Governmental Authorizations, no proceedings are pending or, to the Knowledge of the Seller, threatened, which could result in their revocation or limitation and all steps have been taken and filings made on a timely basis with respect to each Governmental Authorization and its renewal; in each case, except as would not reasonably be expected to have a material adverse effect on the Purchased Assets.

5.11 Contracts . All current and complete copies of all Contracts have been delivered to or made available to the Buyer. The Contracts are all in full force and effect and, to Seller’s Knowledge, there are no outstanding defaults or violations under such Contracts on the part of the Seller or, to the Knowledge of the Seller, on the part of any other party to such Contracts and there are no current or pending negotiations with respect to the renewal, repudiation or amendment of any Contract. The Seller Insurance Policies completely satisfy any and all insurance obligations of Buyer under all Contracts. All provisions relating to Chargebacks related to Channel Inventory and product returns, applicable to the Assumed Liability Contracts, whether such provisions relate to direct parties to the Assumed Liability Contracts or to final customers of the Products, have been made available in writing to the Buyer.

 

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5.12 Tax Matters . In each case except as would not reasonably be expected to have a material adverse effect on the Purchased Assets:

(a) No failure, if any, of the Seller to duly and timely pay all Taxes, including all installments on account of Taxes for the current year, that are due and payable by it will result in an Encumbrance on the Purchased Assets;

(b) There are no proceedings, investigations, audits or claims now pending or threatened against the Seller in respect of any Taxes, and there are no matters under discussion, audit or appeal with any governmental authority relating to Taxes, which will result in an Encumbrance on the Purchased Assets;

(c) The Seller has duly and timely withheld all Taxes and other amounts required by law to be withheld by it relating to the Purchased Assets (including Taxes and other amounts relating to the Purchased Assets required to be withheld by it in respect of any amount paid or credited or deemed to be paid or credited by it to or for the account or benefit of any Person, including any employees, officers or directors and any non-resident Person), and has duly and timely remitted to the appropriate Governmental Authority such Taxes and other amounts required by law to be remitted by it; and

(d) The Seller has duly and timely collected all amounts on account of any sales or transfer taxes, including goods and services, harmonized sales and provincial or territorial sales taxes with respect to the Purchased Assets, required by law to be collected by it and has duly and timely remitted to the appropriate Governmental Authority any such amounts required by law to be remitted by it.

5.13 Cell Banks . The Cell Banks are in viable condition as of the Closing and have been stored in accordance with any and all applicable laws, rules, regulations, Governmental Authorizations and the quality procedures in accordance with cGMP.

 

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5.14 Environmental Matters . Except as set forth on Schedule 5.14 , the Seller is in compliance in all respects with all applicable Environmental Laws to the extent such compliance or lack thereof would have any impact on the Seller’s business related to the production, sale and distribution of the Products or the Seller’s ability to consummate the transactions contemplated herein in accordance with the terms hereof (such impact, a “ Product Impact ”). The Seller has not received any written communication that alleges that the Seller is not in compliance in all respects with all applicable Environmental Laws. All permits and other governmental authorizations currently held by Seller pursuant or in connection with any Environmental Law are in full force and effect, Seller is in compliance in all respects with all of the terms of such permits and authorizations to the extent such compliance or lack thereof would have any Product Impact, and no other permits or authorizations material to the conduct of the Seller’s business related to the production, sale and distribution of the Products are required by the Seller. Except as set forth on Schedule 5.14 , the management, handling, storage, transportation, treatment and disposal by Seller of all Hazardous Substances have been in compliance in all respects with all applicable Environmental Laws to the extent such compliance or lack thereof would have any Product Impact.

5.15 Chargebacks . The sum of all Chargebacks related to the Channel Inventory bearing National Drug Code (NDC) number 0074-6109-05 as more particularly set forth on Schedule 2.3(b) can be no greater than $500,000.

5.16 Regulatory Compliance . The Seller has been, and is in compliance, in all material respects with applicable provisions of the FDCA and the regulations of the FDA promulgated thereunder with respect to the Product, except where the failure to have the same would not have a material adverse effect and the Seller has not received any notice (oral or written) of Proceedings relating to the revocation, withdrawal, recall, or modification of any Governmental Authorization. Seller has been and is in compliance in all materials respects with the FDCA and FDA regulations with respect to manufacturing, clinical research and development, submission of applications for review by governmental authorities, marketing, promotion, and sale of the Product. Except as set forth on Schedule 5.16 , there are no pending or, to the knowledge of the Seller, threatened actions or proceedings by the FDA or U.S. Department of Justice, which would prohibit or impede the sale or marketing of the Product.

5.17 Disclaimer . EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS ARTICLE 5, SELLER IS MAKING NO REPRESENTATION OR WARRANTY AS TO THE PURCHASED ASSETS. For greater certainty, nothing in this Section 5.17 shall in any way limit Seller’s indemnification obligations as set forth in Article 10 .

 

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ARTICLE 6

Representations and Warranties of Buyer

Buyer represents and warrants to Seller as follows:

6.1 Organization . Buyer is a corporation duly incorporated and validly existing in good standing under the laws of the Province of Ontario, Canada, duly qualified to transact business as a foreign corporation in all jurisdictions except where the failure to be so qualified would not reasonably be expected to have a material adverse effect on Buyer, and with all requisite corporate power and authority to own, lease and operate its properties and to carry on its business as now being conducted.

6.2 Due Authorization . Buyer has full corporate power and authority to execute, deliver and perform its obligatio


 
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