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PRODUCT RIGHTS ACQUISITION AGREEMENT

Asset Purchase Agreement

PRODUCT RIGHTS ACQUISITION AGREEMENT | Document Parties: Jazz Pharmaceuticals, Inc | JPI Commercial, LLC | JPIC COMMERCIAL, LLC | PALADIN LABS (BARBADOS) INC | PALADIN LABS (BARDADOS) INC | Paladin Labs (USA) Inc | Paladin Labs Inc You are currently viewing:
This Asset Purchase Agreement involves

Jazz Pharmaceuticals, Inc | JPI Commercial, LLC | JPIC COMMERCIAL, LLC | PALADIN LABS (BARBADOS) INC | PALADIN LABS (BARDADOS) INC | Paladin Labs (USA) Inc | Paladin Labs Inc

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Title: PRODUCT RIGHTS ACQUISITION AGREEMENT
Governing Law: New York     Date: 8/6/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

PRODUCT RIGHTS ACQUISITION AGREEMENT, Parties: jazz pharmaceuticals  inc , jpi commercial  llc , jpic commercial  llc , paladin labs (barbados) inc , paladin labs (bardados) inc , paladin labs (usa) inc , paladin labs inc
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Exhibit 10.76

Execution Copy

ANTIZOL ®

PRODUCT RIGHTS ACQUISITION AGREEMENT

Dated as of August 1, 2008

by and among

JPI COMMERCIAL, LLC,

JAZZ PHARMACEUTICALS, INC.

and

PALADIN LABS (BARBADOS) INC.

PALADIN LABS (USA) INC.


ANTIZOL ®

PRODUCT RIGHTS ACQUISITION AGREEMENT

This Antizol ® Product Rights Acquisition Agreement (with the attached Exhibits and Schedules the “Agreement”) is entered into as of the 1 st day of August, 2008 (“Effective Date”) by and among Paladin Labs (Barbados) Inc. (“PURCHASER”), a Barbados corporation, Paladin Labs (USA) Inc., a Delaware corporation (“P-USA”), Jazz Pharmaceuticals, Inc., a Delaware corporation (“Parent”), and JPI Commercial, LLC., a Delaware limited liability company (“JPIC,” and, together with Parent, “SELLER”)

A. SELLER owns the rights to the Product (as defined below) and certain associated rights and assets.

B. SELLER desires to sell and transfer to PURCHASER, and PURCHASER desires to acquire and assume from SELLER, all right, title and interest in and to the Product and certain related assets and liabilities, all on the terms and subject to the conditions in this Agreement.

NOW THEREFORE, in consideration of the mutual covenants and agreements provided herein, the parties agree as follows:

1. Definitions

1.1. “ Act ” means the United States Food, Drug and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder.

1.2. “ Affiliate ” of a party means any corporation or other business entity controlled by, controlling or under common control with, such party. For purposes of this definition “control” shall mean (i) ownership of fifty percent (50%) or more of the voting power entitled to vote for the election of directors, in the case of a corporation, or (ii) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such party, whether through the ownership of voting securities, by contract or otherwise.

1.3. “ Assigned Contracts ” means those agreements listed on Exhibit A attached hereto.

1.4. “ Assigned Domain Names ” means the Domain Names which are owned, licensed or otherwise controlled by SELLER and which are necessary or appropriate for the manufacture, production, distribution, marketing and/or use of the Product, including those listed in Exhibit B attached hereto.

1.5. “ Assigned Patent Rights ” means the Patent Rights which are owned, licensed or otherwise controlled by SELLER and which are necessary or appropriate for the manufacture, production, distribution, marketing and/or use of the Product, including those listed in Schedule 1 to Exhibit E attached hereto, including any patent(s) issuing therefrom.

1.6. “ Assigned Trademarks ” means the Trademarks which are owned, licensed or otherwise controlled by SELLER and which are necessary or appropriate for the manufacture, production, distribution, marketing and/or use of the Product, including those listed in Schedule 1 to Exhibit D attached hereto.

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


1.8. “ Business Records ” has the meaning set forth in Section 2.1.

1.9. “ Claims ” has the meaning set forth in Section 8.2.

1.10. “ Closing Date ” means August 5, 2008.

1.11. “ Closing Payment ” has the meaning set forth in Section 3.1(a).

1.12. “ Confidentiality Agreement ” means the letter agreement between the parties dated September 14 , 2005, as amended from time to time, covering the confidentiality of certain information relating to the Product.

1.13. “ Contracts ” means all contracts, agreements, licenses, supply contracts, purchase orders, sales orders, and other instruments, commitments, obligations, arrangements or understandings, whether written or oral.

1.14. “ Domain Names ” means all Internet electronic addresses, uniform resource locators and alphanumeric designations associated therewith and all registrations for any of the foregoing.

1.15. “ Encumbrances ” means any and all liens, claims, charges, security interests, mortgages, easements, covenants, pledges, options, preemptive rights, rights of first refusal or first offer, proxies, levies, voting trusts or agreements, or other adverse claims or restrictions on title or transfer of any nature whatsoever.

1.16. “ Excluded Arrangements ” has the meaning set forth in Section 2.6.

1.17. “ Excluded Assets ” means all assets of SELLER other than the Purchased Assets.

1.18. “ Excluded Liabilities ” means all liabilities of SELLER other than the Assumed Liabilities.

1.19. “ FDA ” means the United States Food and Drug Administration or any successor United States government agency performing similar functions with respect to pharmaceutical products.

1.20. “ Governmental Authority ” means any international, supranational, national, provincial, regional, federal, state, municipal or local government, any instrumentality, subdivision, court, administrative or regulatory agency, department, board or commission or other authority thereof; any quasi-governmental or private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority; or any arbitrator.

1.21. “ Governmental Order ” means any decision, ruling, order, charge, writ, judgment, injunction, decree, stipulation, determination, award or binding agreement issued, promulgated or entered by or with any Governmental Authority.

1.22. “ Government Program Payment ” has the meaning set forth in Section 2.3(e).

1.23. “ Inventory ” means all of the Product components, finished goods and work in process inventory owned by SELLER as of the Effective Date.

1.24. “ Law ” means any applicable U.S. or foreign, supranational, national, federal, state, provincial, local or common law, act, statute, ordinance, regulation, rule or code promulgated by a Governmental Authority and any Governmental Order.


1.25. “ Net Sales ” means the gross amounts invoiced by PURCHASER and its affiliates and sublicensees on all sales of the Product to independent unrelated third parties in bona fide arms’ length transactions (including, but not limited to, hospital sales, mail orders, retail sales, and sales to federal or state governments, wholesalers, medical institutions, etc.), less (a) transportation and freight charges, including insurance and handling, to the extent that such charges are included in the gross amounts invoiced in connection with the transport of the Product; (b) sales, use and excise taxes, value added taxes, and duties which fall due and are paid as a consequence of such sales by the party or its affiliates or sublicensees and any other governmental charges imposed upon the importation, use or sale of the Product; and (c) the following deductions actually allowed and taken by such third parties and not otherwise recovered by or reimbursed to the party or its Affiliates: (i) trade, quantity and cash discounts; (ii) allowances or credits on account of rejection, defects, recall or returns of a Product or on account of retroactive price reductions or wholesaler chargebacks affecting the Product; and (iii) rebates, refunds, reductions and charge backs specifically related to the Product including those granted to insurers, buying groups, government agencies or similar bodies. “Net Sales” shall not include any sales among a party and its affiliates and sublicensees and for purposes of this Net Sales definition, PURCHASER shall mean PURCHASER and any subsequent purchasers of all or some of the rights to either or both of Antizol ® (fomepizole) or Antizol-Vet ® (fomepizole).

1.26. “ Patent Rights ” means all patents and patent applications, including any patents of addition, re-examinations, reissues, extensions, granted supplementary protection certifications, substitutions, confirmations, registrations, revalidations, revisions, additions and the like, and any and all divisionals, continuations and continuations-in-part.

1.27. “ Person ” means any natural person, corporation, general partnership, limited partnership, limited or unlimited liability company, proprietorship, joint venture, other business organization, trust, union, association or Governmental Authority.

1.28. “ Product ” means either or both of the products Antizol ® (fomepizole) and Antizol-Vet ® (fomepizole) in the current commercial form sold by or on behalf of SELLER.

1.29. “ Product Information ” has the meaning set forth in Section 2.1.

1.30. “ Product Payment Term ” has the meaning set forth in Section 3.3(a).

1.31. “ Product Payment Year ” has the meaning set forth in Section 3.3(b).

1.32. “ Product Registrations ” means the Product NDA, IND, DIN and other registrations, authorizations and approvals of any regulatory authority, necessary for the commercialization of the Product, owned by the SELLER and existing as of the Effective Date.

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

1.34. “ Registration Office ” means the United States Patent and Trademark Office or equivalent authorities anywhere in the world.

1.35. “ Representatives ” means, with respect to any Person, such Person’s officers, directors, employees, agents, counsel, accountants, financial advisors, lenders, consultants and other representatives.


1.36. “ Transition Services End Date ” has the meaning assigned such term in the Transition Services Agreement between Jazz Pharmaceuticals, Inc. and Paladin Labs (Barbados) Inc. and dated the date herein.

1.37. “Trademarks ” means all trademarks, service marks, logos, trade dress and trade names indicating the source of the Product all registrations and applications to register the foregoing anywhere in the world and all goodwill associated therewith.

1.38. “ Trademark Assignment ” means the assignment substantially in the form attached as Exhibit D hereto.

1.39. “ Transition Services Agreement ” has the meaning set forth in Section 4.3(c).

2. Transfer of Purchased Assets and Assumption of Assumed Liabilities

2.1 Transfer of Assets . Effective as of the Effective Date, and subject to the terms and conditions of this Agreement, SELLER shall sell, assign, convey and transfer to or to the order of PURCHASER, and PURCHASER (and/or the Person designated by PURCHASER) hereby purchases and accepts from SELLER, all of the right, title and interest in, to and under the following assets (collectively, the “ Purchased Assets ”):

(a) the Product Registrations (such transfer to be completed in accordance with Section 2.2 below);

(b) Inventory and any Product-specific packaging components, to the extent owned by SELLER, whether in the possession of SELLER or in the possession of any third party and held for the benefit of SELLER;

(c) all rights and incidents of SELLER under the Assigned Contracts;

(d) the Assigned Domain Names;

(e) the Assigned Trademarks;

(f) the Assigned Patent Rights;

(g) copies of all books and records of SELLER and, to the extent SELLER has knowledge and possession of them, Orphan Medical, relating to the Product from January 1, 2005 to the present; provided that if such books and records contain information related to other products, services or businesses of SELLER, the information relating solely to such other products, services or businesses may be redacted (“ Business Records ”);

(h) lists of customers, including hospitals, and suppliers of the Product, including in the case of suppliers information concerning historical purchase orders and other correspondence from June 24, 2005 to present;

(i) except as otherwise described in this Agreement, all rights, claims and causes of action that are related to any of the Assumed Liabilities or any of the Purchased Assets, but excluding rights, claims and causes of action that are related to Excluded Liabilities;

(j) except as otherwise described in this Agreement, all rights, claims and credits of SELLER under or pursuant to all warranties, representations and guarantees made by suppliers, manufacturers and contractors in connection with the Product on or after the Effective Date (but excluding any such items arising under insurance policies);


(k) the know-how and other intellectual property rights in possession or control of Seller and used for the Product, including the specifications, results of pre-clinical and clinical trials, data and documentation and other information regarding but not limited to inventions, designs, discoveries, developments, processes, manufacture, formulations, analytical and quality control, distribution, sale and/or use of the Product to which SELLER has rights;

(l) all goodwill associated with the Purchased Assets; and

(m) to the extent such information is within the possession of, or available to, SELLER as of the Effective Date, copies of the following:

(i) files pertaining to the Product Registrations in the United States of America, including material correspondence with the FDA;

(ii) clinical data relating to the Product;

(iii) technical, chemical, pharmacological and toxicological data generated specifically for the Product, if any; and

(iv) promotional and marketing materials used specifically with respect to the Product, including advertising materials, price lists, sales materials, marketing information, artwork for the production of packaging components and other materials associated solely and specifically with the Product (items i, ii, iii and iv together, “ Product Information ”).

All Purchased Assets will be delivered via electronic transfer to the extent reasonably practicable, and the delivery of any tangible Purchased Assets shall occur as promptly as reasonably practicable on or after the Closing Date; provided, however, that both parties, together, may agree to delay any delivery of the foregoing to accomplish the purposes of the Transition Services Agreement. The filing of the assignment form for the Assigned Trademarks with the U.S. Patent and Trademark Office, and any required actions ancillary thereto, shall be the sole responsibility of PURCHASER. SELLER may retain a copy of the documentation that it delivers to PURCHASER hereunder to monitor its obligations hereunder and to comply with all Laws and Agreements.

2.2 Filings Regarding Transfer of Product Registrations . SELLER and PURCHASER will establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Product Registrations. Promptly after the Closing Date, the parties shall file with the FDA, and any other relevant regulatory authorities where SELLER has the right to do so, all information required in order to transfer the Product Registrations from SELLER to PURCHASER. SELLER shall file the information required of a former owner, and PURCHASER shall file the information required of a new owner, at each party’s own expense. Both parties also agree to use commercially reasonable efforts to take any actions required by regulatory authorities or other government/health agencies to effect the transfer of the Product Registrations from SELLER to PURCHASER. The parties agree to use commercially reasonable efforts to complete the filing of the transfer of the Product Registrations within ten (10) business days after the Closing Date; provided, however, that both parties, together, may agree to delay the filing as reasonably necessary to assist in the transition of the Product from SELLER to PURCHASER. SELLER may retain a copy of the Product Registrations to monitor its obligations hereunder and its compliance with all Laws.


2.3 Assumed Liabilities . Effective as of the Effective Date, PURCHASER assumes, and agrees to perform and discharge when due, except to the extent contested in good faith, and in all cases in accordance with the respective terms and subject to the respective conditions thereof, all of the following (collectively, the “ Assumed Liabilities ”):

(a) all actions and claims (including any liabilities relating to voluntary or involuntary recalls of Product or use of the Trademark) resulting from the sale of the Product made on or after the Effective Date ;

(b) all obligations incurred on and after the Effective Date under the Assigned Contracts;

(c) all liabilities arising on and after the Effective Date relating to the Purchased Assets;

(d) any returns of Product received after the Effective Date;

(e) all Product-related chargebacks, rebates or any other post-sale rebates, refunds, Medicare reimbursements, price adjustments and other similar payments, credits or liabilities received after the Effective Date, except that SELLER shall be responsible for any such payments related to the invoices received from Medicare, Medicaid and state programs for the sales of Products for the period ending September 30, 2008 (the “ Government Program Payment ”); and

(f) all Product-related credits, utilization-based rebates, reimbursements, and similar payments to buying groups, insurers and other institutions received after the Effective Date.

2.4 Claims with Respect to Assumed Liabilities . In the event of any claim against PURCHASER with respect to any of the Assumed Liabilities, PURCHASER shall have, and SELLER hereby assigns to PURCHASER, any defense, counterclaim or right of setoff that would have been available to SELLER if such claim had been asserted against SELLER.

2.5 Excluded Liabilities . PURCHASER is not assuming, and shall not be required to pay, perform or discharge, any of the Excluded Liabilities.

2.6 Excluded Arrangements . Contracts, commercial relationships and arrangements relating to Integrated Commercialization Solutions, Inc., are not being assigned or transferred to PURCHASER under this Agreement (the “ Excluded Arrangements ”). PURCHASER acknowledges that PURCHASER will need to make its own arrangements for the distribution of the Product in the United States.

2.7 Inventory . The Inventory and Product-specific packaging components referred to in Section 2.1(h) shall be sold by SELLER directly to P-USA who shall purchase same. The Inventory to be purchased by P-USA is as set forth in Exhibit C . Such Inventory shall be delivered by SELLER to P-USA (or as P-USA may direct). P-USA shall buy such Inventory at no more than the price paid by SELLER (as set forth in Exhibit C ). SELLER represents and warrants that the price to be paid by P-USA for the Inventory is no more than the price SELLER paid for the Inventory without any mark-up, provided that any finished product Inventory, having a shelf life of thirty six (36) months or less determined from the Effective Date, shall be provided to P-USA without any charge from SELLER. SELLER shall provide PURCHASER and its auditors with such information from and access to its books and records so as to be able to verify the cost amount to SELLER of such Inventory.


3. Payments. All payments described in this Agreement are in US Dollars unless otherwise indicated. In consideration of the transfer to PURCHASER and P-USA of the Purchased Assets and the assumption by PURCHASER of the Assumed Liabilities, PURCHASER shall pay the following non-refundable, non-creditable payments to SELLER:

3.1 Upfront Payment . $5.5 million by wire transfer on the Closing Date (the “Closing Payment”) payable by PUCHASER.

3.2 Payment for Inventory . The price paid by P-USA for the Inventory as set forth on Exhibit C and as determined in accordance with Section 2.7.

3.3 Product Payments on Net Sales of Product .

(a) Product Payment Term . Product Payments as provided in this Section 3.3 will be payable by PURCHASER to SELLER on an annual basis during the period commencing on October 1, 2008 and ending on September 30, 2011 (the “Product Payment Term”).

(b) Product Payments . Throughout the Product Payment Term, product payments will be paid on Net Sales for each consecutive 12 month period beginning on October 1, 2008 (each a “Product Payment Year”) as follows:

 

 

 

 

 

On Net Sales in any Product Payment Year

  

Product Payment Rate

 

Up to $1,750,000

  

0

%

On that portion of Net Sales that are more than $1,750,000 and up to $3,250,000

  

20

%

On that portion of Net Sales that are more than $3,250,000

  

60

%

3.4 Manner of Payment; Reports . Payments to SELLER due under Section 3.3 will be made within sixty (60) days after the end of each Product Payment Year with respect to Net Sales of the Product during such Product Payment Year. Within sixty (60) days after the end of each calendar quarter during the Product Payment Term, PURCHASER will provide a report to SELLER setting forth the number of units of Product sold for each of Antizol and Antizol-Vet, the gross sales and Net Sales of the Product (stating Antizol and Antizol-Vet separately). Within sixty (60) days after the end of the Product Payment Year, PURCHASER will provide a report to SELLER setting forth the calculations determining the amounts payable, if any, to SELLER for the Product Payment Year, including, without limitation the number of units of Product sold for each of Antizol and Antizol-Vet, the gross sales and Net Sales of the Product (stating Antizol and Antizol-Vet separately), the product payments payable, the method used to calculate the product payments, and the exchange rates used.

3.5 Late Payments . In the event that any payment due under this Agreement is not made when due, the payment shall accrue interest from the date due at the rate of one percent (1.0%) per month; provided, however, that in no event shall such rate exceed the maximum legal annual interest rate. The payment of such interest shall not limit the SELLER from exercising any other rights it may have as a consequence of the lateness of any payment.


3.6 Records; Audits . For a period of four (4) years beginning on the Closing Date, PURCHASER will keep, and will cause its Affiliates and sublicensees to keep, complete and accurate records pertaining to the sale or other disposition of Product by itself, its Affiliates and their respective sublicensees, in sufficient detail to permit the SELLER to confirm the accuracy of all payments due hereunder. SELLER shall have the right to cause an independent, certified public accountant reasonably acceptable to the PURCHASER to audit such records to confirm such Net Sales, product payments and other payments for a period covering not more than the preceding three (3) years. Such audits may be exercised during normal business hours upon reasonable prior written notice to the PURCHASER, and subject to an appropriate confidentiality agreement. Prompt adjustments shall be made by the parties to reflect the results of such audit. SELLER shall bear the full cost of such audit unless such audit discloses an underpayment by the PURCHASER of at least the greater of (i) $25,000 or (ii) five percent (5%) of the amount of product payments or other payments due under this Agreement for the period audited, in which case the PURCHASER will pay the full cost of such audit.

3.7 Purchase Price Allocation . To the extent permitted by Law and the parties respective independent accountants, the purchase price shall be allocated among the Purchased Assets in the manner set forth in Exhibit F hereto.

4. Closing.

4.1 Closing Deliveries by PURCHASER. On the Closing Date, PURCHASER shall deliver or cause to be delivered to SELLER:

(a) A certificate of insurance evidencing worldwide coverage and products liability limits equal to at least $5 million;

(b) An amount equal to the Closing Payment plus payment for the Inventory, by wire transfer of immediately available funds to such account as SELLER may direct;

(c) Such further instruments and documents as may be required to be delivered by PURCHASER pursuant to the terms of this Agreement or as may be reasonably requested by SELLER in connection with the closing of the transactions contemplated hereby or to complete the assumption by PURCHASER of the Assumed Liabilities.

4.2 Closing Deliveries by SELLER . On the Closing Date, SELLER shall deliver or cause to be delivered to PURCHASER:

(a) Subject to Section 2.1, possession of the Purchased Assets, including all Assigned Contracts, Business Records and Product Information of SELLER, to the extent in SELLER’s possession or control and not previously provided to PURCHASER;

(b) The Trademark Assignment executed by SELLER;

(c) The Trans


 
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