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