Exhibit 2.1(b)o
[*] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS
BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES ACT OF 1934, AS
AMENDED.
ASSET PURCHASE
AGREEMENT
By and between
VICTORY
PHARMACEUTICALS
AND
ACCENTIA BIOPHARMACEUTICALS, INC.
AND TEAMM PHARMACEUTICALS, INC.
October 27,
2006
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
AGREEMENT TO LICENSE/TRANSFER
ASSETS
This Agreement between TEAMM
Pharmaceuticals, Inc., a Florida Corporation having a place of
business at 2501 Aerial Center Parkway, Morrisville, NC 27560 and
its parent company, Accentia Biopharmaceuticals, Inc. (hereinafter
each individually, and both collectively, “ACCENTIA”),
a Florida corporation having a place of business at 324 S. Hyde
Park Avenue, Suite 350, Tampa, FL 33606, and Victory Pharma, Inc.,
a California corporation with a place of business at 12707 High
Bluff Drive, Suite 200; San Diego, CA 92130(“VICTORY”)
made this 27th day of October, 2006 (the “Closing
Date”), is as follows:
WHEREAS , Ryan Pharmaceuticals, LLC a licensor and
developer of pharmaceutical products, with corporate address 251
Loring Ave., Pelham, New York 10803 ( “Ryan” )
and Mikart, Inc., a Georgia corporation, with corporate offices at
1750 Chattahoochee Ave., Atlanta, GA 30318 (
“Mikart” ), have completed a development project
to formulate, develop, obtain FDA approval, and commercialize a
pharmaceutical product comprised primarily of 10mg of hydrocodone
and 300mg of acetaminophen (the “10/300 Product”
);
WHEREAS , Argent Development Group, LLC, a California
limited liability company, with a corporate address at 809 Arroyo
Road, Los Altos, CA 94204 (“ Argent ”) and
Mikart have completed a development project to formulate, develop,
obtain FDA approval, and commercialize two pharmaceutical products:
the first comprised primarily of 5mg of hydrocodone and 300mg of
acetaminophen (the “5/300 Product” ) and the
second comprised primarily of 7.5mg of hydrocodone and 300mg of
acetaminophen (the “7.5/300 Product” )
;
WHEREAS , Mikart filed with the FDA, and is the holder
and owner of, an abbreviated new drug application
(“ANDA”) for approval to market the 10/300 Product in
the Territory, which ANDA was subsequently approved on
June 23, 2004 as Approval No. 040556 (product
1);
WHEREAS , Mikart filed with the FDA, and is the holder
and owner of, an ANDA for approval to market the 5/300 Product
subsequently approved on January 19th, 2006 as Approval
No. 040658 and the 7.5/300 Product in the Territory, which
ANDA was subsequently approved on March 24th, 2006 as Approval
No. 040556 (product 2);
WHEREAS , Ryan owns the exclusive commercial rights in
the Territory to sell the 10/300 Product under the ANDA therefor
held by Mikart;
WHEREAS , Argent owns the exclusive commercial rights in
the Territory to sell the 5/300 Product and the 7.5/300 Product
under the ANDA therefor held by Mikart;
WHEREAS , capitalized terms used in this preamble
section shall have the meanings therefor as set forth herein and in
Section 1 below;
WHEREAS , Ryan has previously granted a sublicense to
Accentia pursuant to that certain Distribution Agreement dated
May 23, 2003 and as subsequently amended (the “Ryan
Distribution Agreement” ), to “sell”
(as that term is defined in the Ryan Distribution Agreement) the
10/300 Product in the Territory;
WHEREAS , Argent has previously granted a sublicense to
ACCENTIA pursuant to that certain Distribution Agreement dated
May 12, 2004 and as subsequently amended (the “
Argent
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Distribution
Agreement” ), to
“sell” (as that term is defined in the Argent
Distribution Agreement) the 5/300 Product and the 7.5/300 Product
in the Territory;
WHEREAS , the Ryan Distribution Agreement has been
terminated on even date herewith by operation of the Ryan
Termination Agreement;
WHEREAS , the Argent Distribution Agreement has been
terminated on even date herewith by operation of the Argent
Termination Agreement;
WHEREAS , Victory has entered into that certain supply
agreement with Mikart dated October 27, 2006 (“Mikart
Supply Agreement”) to provide for the manufacture and supply
of the 10/300 Product;.
WHEREAS , Victory has entered into that certain
sublicense agreement with Ryan, dated October 26, 2006
(“Ryan Sublicense Agreement”) to provide for the
manufacture and supply of the 10/300 Product;
WHEREAS , Victory has entered into that certain
sublicense agreement with Argent, dated October 26, 2006
(“Argent Sublicense Agreement”) to provide for the
manufacture and supply of the 5/300 Product and 7.5/300
Product;
WHEREAS , ACCENTIA has agreed with Victory to the
transfer of certain ACCENTIA intellectual property and other assets
related to the 5/300 Product, the 7.5/300 Product, and the 10/300
Product as set forth more fully herein.
For good and valuable consideration,
and the covenants, conditions, and undertakings hereinafter set
forth, the receipt, adequacy and sufficiency of which are hereby
acknowledged, it is agreed by and among the parties as
follows:
ARTICLE 1
DEFINITIONS
Certain Terms
. For purposes hereof, the following
terms shall have the meanings set forth below:
“5/300
Product” has the
meaning as set forth in the preamble.
“7.5/300
Product” has the
meaning as set forth in the preamble.
“10/300
Product” has the
meaning as set forth in the preamble.
“Act”
means the Federal Food, Drug, and
Cosmetic Act, as amended from time to time, and the rules and
regulations promulgated thereunder.
“Affiliate” means, with respect to any Person, any other
Person that (directly or indirectly) is controlled by, controls, or
is under common control with such Person. For purposes of this
definition, the term “control” (including, with
correlative meanings, the terms “controlled by” and
“under common control with”) as used with respect to a
Person means direct or indirect beneficial or legal ownership of
more than fifty percent (50%) of the voting interest in, or
more
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than fifty percent (50%) of the equity of
or the right to appoint more than fifty percent (50%) of the
directors or managers of the corporation or other business entity
or the power to direct or cause the direction of the management and
policies of such corporation or entity, whether pursuant to the
ownership of voting securities, by contract or
otherwise.
“ Argent Sublicense
Agreement ” means that certain sublicense agreement
between Argent Development Group LLC (“Argent”) and
Victory dated October 26, 2006 and attached hereto as Exhibit
A.
“ Argent Termination
Agreement ” means that certain agreement between Argent
and Accentia terminating the Argent Distribution Agreement, dated
October 26, 2006 and attached hereto as Exhibit B.
“ Assets ” means
the XODOL IP, XODOL Domain Name, and XODOL Inventory.
“cGMP”
means the current Good Manufacturing
Practices regulations of the FDA (as in effect from time to time)
contained in 21 CFR §§ 210 and 211.
“Confidential
Information” shall
have the meaning set forth in Article 7.
“Closing
Date” means the
date on which the Closing occurs.
“ Escrow Agreement
” shall have the meaning set forth in section 2.6 and is
attached hereto as Exhibit F.
“FDA”
means the United States Food and
Drug Administration or any successor government agency.
“Person”
means a natural person, corporation,
partnership, company or other entity.
“Product”
means any and all of the 10/300
Product, the 5/300 Product, and the 7.5/300 Product.
“ Purchase Price
” shall have the meaning set forth in section 2.6.
“ Ryan Sublicense
Agreement ” means that certain sublicense agreement
between Ryan Pharmaceuticals, Inc. (“Ryan”) and Victory
of even date and attached hereto as Exhibit C.
“ Ryan Termination
Agreement ” means the termination agreement, attached
hereto as Exhibit D, between Ryan and ACCENTIA terminating the Ryan
Distribution Agreement, dated October 26, 2006.
“Territory” means the United States of America, together
with its territories and possessions, including the Commonwealth of
Puerto Rico.
“Trademark” means the Xodol ® trademark, registered with the
United States Patent and Trademark Office as Registration Number
2943009, together with all derivations thereof and including all
goodwill associated with such trademark and derivations, whether
based on common law or the laws of the various states.
“ XODOL Know-How
” means all technical, clinical, manufacturing and testing
information, data and know-how related to Product, whether or not
patentable, owned, possessed
4
or controlled by ACCENTIA as of the Closing
Date, including, without limitation, all such manufacturing
information, processes, testing methods, formulae, discoveries and
inventions, whether relating to biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and
analytical safety, quality control, product sales, marketing data
and clinical data to the extent that such know-how is owned or
controlled by Accentia to allow its’ transfer..
“ XODOL Trade Name
” means all copyrights, trademarks, and trade names
(including, but not limited to, those listed in Schedule A) in the
branding associated with, or applicable to the manufacture, use or
sale of, the Product known and currently or previously sold by
ACCENTIA under the Trademark or otherwise under the trade name
XODOL., including all marketing materials, promotional materials,
promotional items, trade dress, labeling and any other sales and
marketing related data or materials.
“ XODOL IP ”
means the Trademark, XODOL Trade Name, and XODOL
Know-How.
“ XODOL DOMAIN NAME
” means the internet address, domain name, programmed code
software license and all other rights associated with the Xodol.com
website. ACCENTIA will transfer to a third party chosen by VICTORY,
all related files, art, and technical know-how to allow VICTORY to
maintain Xodol.com. ACCENTIA will remove a link from its website,
but will allow it to be freestanding for up to 30 days while
VICTORY connects to Xodol.com. VICTORY will be responsible for
removing ACCENTIA name and logo and replacing it with VICTORY name
and logo.
“ XODOL Inventory
” means Accentia’s inventory of unexpired Product in
the amount listed on Schedule C.
ARTICLE 2
ASSET ACQUISITION
2.1 Effective as of the Closing,
ACCENTIA hereby grants, sells, assigns, transfers and conveys to
VICTORY and VICTORY hereby accepts and acquires from ACCENTIA, free
and clear of all liens, charges, claims and encumbrances all of
ACCENTIA’s right, title and interest throughout the world
under and to the XODOL Assets including all claims for past
infringement or misappropriation of any of the rights and interests
conveyed herein, with the right to enforce, sue for and collect
damages for same.
2.2 Trademark Assignment .
ACCENTIA shall deliver no later than Closing, an executed trademark
assignment in the form attached hereto as Exhibit E (the
“Trademark Assignment”).
2.3 Website Transfer. As of
the Closing, ACCENTIA shall transfer to a third party designated by
VICTORY, all related files, software, codes, art, and technical
know-how associated with the XODOL Domain Name to allow VICTORY to
maintain Xodol.com. As of the Closing, ACCENTIA shall remove all
links between Xodol.com and all other websites under its control
from Xodol.com, and shall allow Xodol.com to be freestanding for up
to 30 days following Closing while VICTORY connects to Xodol.com.
VICTORY will be responsible for removing ACCENTIA name and logo and
replacing it with VICTORY name and logo.
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2.4 Physical Files. As of the
Closing, ACCENTIA shall deliver to VICTORY and place VICTORY in
possession of all embodiments, whether in physical or electronic
form, of the XODOL IP in the possession or control of ACCENTIA,
including, but not limited to, the Trademark prosecution files and
a CD containing the contents of the sales training manual. All
promotional materials, promotional items, marketing materials,
sales materials listed in Schedule G that VICTORY has agreed to
purchase.
2.5 Inventory . As of
Closing, ACCENTIA shall transfer the XODOL inventory to VICTORY, to
be delivered F.O.B. ACCENTIA’s warehouse facility and
transported to VICTORY’s chosen location at VICTORY’s
cost by a carrier selected by VICTORY. The transfer shall occur
within 5 days of Closing.
2.6 Purchase Price . In
consideration of the transfer of Assets and Inventory and
ACCENTIA’s satisfaction of all of the conditions precedent to
Closing, Victory shall pay to ACCENTIA the sum of [*] U.S.
dollars ($ [*] ) (“Purchase Price”) by delivery
of the Purchase Price to the escrow agent identified in that
certain Escrow Agreement by and among Ryan, Argent, Accentia,
Victory and U.S. Bank National Association of even date
(“Escrow Agreement”) on the Closing Date. It is
acknowledged and agreed by the parties that the Purchase Price is
contained within the Assets (as defined in the Escrow Agreement)
and that the Escrow Agreement provides that (i) payments to
Ryan of the Ryan Additional Amount (as defined in the Escrow
Agreement), (ii) payments to Argent of the Argent Additional
Amount (as defined in the Escrow Agreement), and
(iii) payments of the escrow agent’s fee shall all be
deducted from the component of the Assets (as defined in the Escrow
Agreement) comprising the Purchase Price before the balance of the
Purchase Price shall be distributed to Accentia pursuant to the
terms of the Escrow Agreement.
ARTICLE 3
CLOSING
3.1 Prior to, and as a condition of,
Closing, ACCENTIA shall provide the following deliverables to
VICTORY:
(a) The Ryan Termination Agreement
and Argent Termination Agreement fully executed by its relevant
parties;
(b) The Ryan Sublicense Agreement
executed by Ryan and the Argent Sublicense Agreement executed by
Argent;
(c) Mikart’s consent to the
Sublicense Agreements;
(d) Confirmation satisfactory to
Victory that Accentia has satisfied its obligations under those
certain two letter agreements among and between Accentia, Ryan and
Argent dated October 4, 2006, October 12, 2006 and
October 23, 2006 including the payment of all monies to Ryan
and Argent contemplated therein; and
(d) Confirmation by Cardinal Health
that it has received a wire transfer from ACCENTIA in the amount of
$ [*] to be applied against current and future returns of
[*] bottles of Xodol 5/300 previously sold under the TEAMM
label (attached as Exhibit G).
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3.2 Upon the occurrence of all
conditions precedent to Closing, Closing shall occur at the offices
of ACCENTIA at 2501 Aerial Center parkway, Morrisville, NC 27560.
The Parties shall exert their best efforts to effect the Closing on
October 27, 2006 by 5pm EDT.
ARTICLE 4
SUPPLY CHAIN
4.1 Chargebacks, Returns and
Marketing Vouchers
(a) ACCENTIA shall send a notice of
termination with respect to the Products for all managed care,
chargeback and other related sales contracts and rebate agreements
for Product within five days after Closing (other than the
contracts for Medicaid and Medco) as listed in Schedule D. VICTORY
shall honor the Xodol pricing discounts for the length of the
termination period stated in the individual contracts. This
notification of termination is subject to provisions in each
contract.
(b) VICTORY shall assume
responsibility for all charge back and rebate claims submitted and
received for the period beginning October 1, 2006 and
thereafter only in accordance with the contracts attached in
Schedule D for Product.
(c) VICTORY shall assume all
financial responsibility for all returns received by either
ACCENTIA or VICTORY after the Closing Date, provided,
however , that:
(i) ACCENTIA will provide VICTORY
supporting documentation for a prepayment issued to Cardinal Health
by ACCENTIA for [*] bottles of 5/300mg Product (at cost of $
[*] per bottle) that is to be returned to ACCENTIA and/or a
third party as designated by ACCENTIA for destruction. The total
wire transfer to Cardinal Health shall be [*] dollars ($
[*] ). Documentation of prepayment to Cardinal Health shall
be in the form of a wire transfer confirmation or proof of
deposited and cleared check, with a copy to VICTORY, either of
which is to be applied toward the 5/300mg Product returns. VICTORY
is to receive documentation that Cardinal has received call tags
from ACCENTIA approving for the return of 5/300 mg Product and
Cardinal has initiated such return..
(ii) ACCENTIA will submit an invoice
and supporting documentation to Victory within thirty
(30) days following the close of each calendar quarter which
shall support ACCENTIA’S full settlement of such returns,
chargebacks and rebates in a manner that is consistent with the
contract terms and/or ACCENTIA’s trade policy at the closing
date. Upon receipt of supporting documentation and a summary
invoice for such claim, VICTORY will review and determine the
reasonableness of such claim and, if in agreement, shall reimburse
ACCENTIA by wire transfer within 30 days upon receipt of invoice.
If a dispute regarding the amount owed arises, VICTORY shall
reimburse ACCENTIA for the non-disputed amount and both parties
will work diligently to resolve the disputed balance in a
reasonable and timely manner.
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(d) VICTORY shall assume liabilities
associated with the Triple i voucher Program relating to coupons
issued / redeemed under the program after the Closing Date.
Accentia agrees to be liable for any unpaid invoices at the Closing
date and for any subsequent invoices for services and/or coupon
redemptions that occurred on or before the Closing date.
4.2 Manufacturing. VICTORY shall
have, as a condition of Closing, entered into a Manufacturing and
Supply Agreement or a signed binding letter of intent to do so with
Mikart, Inc. (Mikart) for the manufacture and supply of Product.
ACCENTIA acknowledges that Victory shall have no liability or
obligation under any supply agreement between ACCENTIA and
Mikart.
4.3 Notification of Customers.
ACCENTIA will notify in writing within 3 days of Closing, all of
its direct purchasing customers that VICTORY has acquired rights to
Product and Trademark and that all future orders for Product must
be placed directly with VICTORY. VICTORY will provide contact
information to ACCENTIA to be provided to ACCENTIA’s
customers in order for orders to be placed with VICTORY. ACCENTIA
agrees to halt the filling of all orders as of the Closing;
thereafter. ACCENTIA will forward all orders for Product, including
both unfilled order receive
