Document:

EX-4.1

Exhibit 4.1

	 	 	 
	AMERICAN BANK NOTE COMPANY 

711 ARMSTRONG LANE 

COLUMBIA, TENNESSEE 38401

(931) 388-3003 

SALES: HOLLY GRONER 615-261-0610 
 
	 	PRODUCTION COORDINATOR: DENISE LITTLE 931-490-1706

PROOF OF: JUNE 24, 2009

AMERICAN INTERNATIONAL GROUP, INC.

TSB 32673 FC 

OPERATOR: AP  
R1

COLORS SELECTED FOR PRINTING: Intaglio prints in SC-3 dark green.

COLOR: This proof was printed from a digital file or artwork on a graphics quality, color laser
printer. It is a good representation of the color as it will appear on the final product.

However, it is not an exact color rendition, and the final printed product may appear slightly
different from the proof due to the difference between the dyes and printing ink.

PLEASE INITIAL THE APPROPRIATE SELECTION FOR THIS PROOF: ___OK AS IS ___OK WITH CHANGES ___
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CERTIFICATE SCANNED FOR PROOFING PURPOSES ONLY.

 

 

AMERICAN INTERNATIONAL GROUP, INC.

     THE COMPANY WILL FURNISH WITHOUT CHARGE TO EACH STOCKHOLDER WHO SO REQUESTS, THE DESIGNATIONS,
PREFERENCES AND RELATIVE, PARTICIPATING, OPTIONAL OR OTHER SPECIAL RIGHTS OF EACH CLASS OF STOCK OR
SERIES THEREOF OF THE COMPANY AND THE QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OF SUCH
PREFERENCES AND/OR RIGHTS. SUCH REQUEST MAY BE MADE TO THE OFFICE OF THE SECRETARY OF THE COMPANY
OR TO THE TRANSFER AGENT.

     The following abbreviations, when used in the inscription on the face of this certificate, shall be
construed as though they were written out in full according to applicable laws or regulations:

	 	 	 	 	 	 	 
	TEN COM

	 	— as tenants in common
	 	UNIF GIFT MIN ACT —
	 	____________ Custodian ____________
	 
	 	 	 	 	 	    (Cust)                              (Minor)  
	TEN ENT

	 	— as tenants by the
entireties
	 	 	 	
under Uniform Gifts to Minors
	 
	 	 	 	 	 	 
	JT TEN

	 	— as joint tenants
with right of
survivorship and not as
tenants in common
	 	 	 	Act __________________

(State)

	 	 	Additional abbreviations may also be used though not in the above list.

For value received, ______________________ hereby sell, assign and transfer unto

	 	 	 
	PLEASE INSERT SOCIAL SECURITY OR OTHER

IDENTIFYING NUMBER OF ASSIGNEE
	 	 
	 
	 	 
	 

 
PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS INCLUDING POSTAL ZIP CODE OF ASSIGNEE.

 

 

 Shares of the capital stock represented by the within Certificate, and do hereby irrevocably
constitute and appoint ___________________

 

Attorney to transfer the said stock on the books of the within-named Company with full power of
substitution in the premises.

Dated,_______________________

 

Signature(s) Guaranteed:

	 	 	 
	

	 	 
	THE SIGNATURE(S) SHOULD BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (BANKS, STOCKBROKERS,
SAVINGS AND LOAN ASSOCIATIONS AND CREDIT UNIONS WITH MEMBERSHIP IN AND APPROVED SIGNATURE GUARANTEE
MEDALLION PROGRAM), PURSUANT TO S.E.C. RULE 17Ad-15.
	 	 

	 	 	 
	AMERICAN BANK NOTE COMPANY 

711 ARMSTRONG LANE 

COLUMBIA, TENNESSEE 38401

(931) 388-3003 

SALES: HOLLY GRONER 615-261-0610 
 
	 	PRODUCTION COORDINATOR: DENISE LITTLE 931-490-1706

PROOF OF: JUNE 24, 2009

AMERICAN INTERNATIONAL GROUP, INC.

TSB 32673 BK (LITHO) 

OPERATOR: AP 

NEW
	 
	 	

PLEASE INITIAL THE APPROPRIATE SELECTION FOR THIS PROOF: ___OK AS ___IS OK WITH CHANGES ___MAKE
CHANGES AND SEND ANOTHER PROOFexv10w1

Exhibit 10.1

EXECUTION VERSION

ASSET PURCHASE AGREEMENT

dated as of July 13, 2009,

between

OSCIENT PHARMACEUTICALS CORPORATION

as Seller,

and

CORNERSTONE BIOPHARMA, INC.

as Buyer

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	 	 	Page	 
	1. Purchase and Sale of the Purchased Assets
	 	 	1	 
	2. Closing; Deliveries
	 	 	7	 
	3. Representations of Seller
	 	 	8	 
	4. Representations of Buyer
	 	 	10	 
	5. Conditions Precedent to the Obligations of Buyer
	 	 	11	 
	6. Conditions Precedent to Obligations of Seller
	 	 	14	 
	7. Covenants of the Parties
	 	 	15	 
	8. Conduct of Auction and Closing of Sale
	 	 	19	 
	9. Notices
	 	 	21	 
	10. Termination
	 	 	22	 
	11. Waiver
	 	 	23	 
	12. Entire Agreement and Modification
	 	 	23	 
	13. Assignment
	 	 	23	 
	14. Severability
	 	 	24	 
	15. Time of the Essence
	 	 	24	 
	16. Governing Law; Bankruptcy Court Jurisdiction
	 	 	24	 
	17. No Third Party Beneficiaries
	 	 	24	 
	18. No Liability of Officers and Directors
	 	 	24	 
	19. Counterparts
	 	 	24	 
	20. Headings
	 	 	25	 

List of Schedules

	 	 	 
	Schedule 1.1.1

	 	Trademarks
	Schedule 1.1.6

	 	Assigned Contract, Additional Assigned Contracts and Cure Amounts
	Schedule 1.1.8

	 	NDA, INDs, and Foreign Regulatory Filings
	Schedule 3.8

	 	Legal Proceedings; Orders
	 
	 	 
	List of Exhibits
	 	 
	 
	 	 
	Exhibit 1.4.3

	 	Joint Escrow Instructions
	Exhibit 5.3(a)

	 	Bill of Sale
	Exhibit 5.3(b)

	 	Assumption and Assignment Agreement

 

 

ASSET PURCHASE AGREEMENT

     THIS ASSET PURCHASE AGREEMENT (this “Agreement”) is made as of July 13, 2009, between
Oscient Pharmaceuticals Corporation, a Massachusetts corporation (“Seller”), and
Cornerstone BioPharma, Inc., a Nevada corporation (“Buyer”).

     WHEREAS, Seller expects to file a petition under Title 11, United States Code (the
“Bankruptcy Code”) with the United States Bankruptcy Court for the District of
Massachusetts (the “Bankruptcy Court”) commencing a case under Chapter 11 of the Bankruptcy
Code (the “Bankruptcy Case”) shortly after the execution of this Agreement;

     WHEREAS, Seller (as successor in interest to Genesoft Pharmaceuticals, Inc.) holds a license
with LG Life Sciences, Ltd. (“LGLS”) dated as of October 22, 2002 (as amended, the
“License”) to develop and commercialize gemifloxacin (the “Active Ingredient”), a
compound marketed by Seller under the trademark FACTIVE for the five-day treatment of acute
bacterial exacerbations of chronic bronchitis and community-acquired pneumonia (the
“Product”); and

     WHEREAS, Buyer desires to purchase from Seller the License and substantially all of the assets
of Seller related to the Product free and clear of liens, claims, and encumbrances pursuant to
section 363(f) of the Bankruptcy Code and to assume only certain specified liabilities of Seller
related thereto, all on the terms and subject to the conditions set forth in this Agreement;

     NOW, THEREFORE, in consideration of these premises, the respective covenants of Buyer and
Seller set forth below and other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the parties agree as follows:

     1. Purchase and Sale of the Purchased Assets.

     1.1. Assets Being Sold to Buyer. Seller agrees to sell and assign to Buyer free and clear of
all Liens (as hereinafter defined) (other than liabilities that Buyer will assume pursuant to
Section 1.3), and Buyer agrees to purchase at the Closing (as hereinafter defined) and thereafter
as provided herein, all of Seller’s right, title and interest in, to and under the following assets
other than Excluded Assets (as hereinafter defined) (collectively, the “Purchased Assets”)
as the same exist on the date hereof and on the Closing Date (as hereafter defined) and any other
delivery or assignment date:

     1.1.1. All rights to the name “FACTIVE” and all other registered and unregistered
United States and foreign trademarks, trade names, service marks, trade dress, logos,
designs, brand names and domain names and all related applications (“Trademarks”)
related solely to the Product and the goodwill associated therewith, including without
limitation the trademarks listed on Schedule 1.1.1 hereto;

     1.1.2. All customer, distributor, and supplier information, historical sales,
marketing, and other information, historical profit and loss statements, and other
financial records related solely to the Product (“Records”);

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     1.1.3. Without limiting any other provision of this Section 1.1, all customer and
supplier lists related solely to the Product, including without limitation mailing lists,
warranty lists, and all related files and data bases;

     1.1.4. All rights in the website content and domain name http://www.factive.com and
any intellectual property related thereto, but excluding any Seller Trade Dress (as
hereinafter defined);

     1.1.5. All inventory of Seller usable or salable in the ordinary course of business
(whether raw materials, work-in-process, or finished goods) related solely to the
Product, together with related packaging materials, product samples, and all rights of
Seller to acquire inventory in the possession or control of third parties, including
inventory of the Active Ingredient in the possession or control of Patheon Inc.
(“Inventory”), provided that (a) Buyer and Seller shall meet at least two
business days prior to the Closing Date contemplated by this Agreement to identify usable
or salable Active Ingredient and (b) Seller may sell to any third party any Active
Ingredient that Buyer has identified as not usable or salable;

     1.1.6. All rights of Seller under (a) the License (the “Assigned Contract”)
and (b) licenses, contracts, and agreements related solely to the Product listed on
Schedule 1.1.6 hereto that Buyer shall elect to have Seller assume and assign to
Buyer by notice to Seller in writing before the Sale Hearing Date, it being agreed that
Seller will make all necessary motions and take any other appropriate actions in the
Bankruptcy Case to cause any such contract or agreement to be assigned to Buyer
(“Additional Assigned Contracts”), provided that Buyer may withdraw such notice
and direct Seller to reject any Additional Assigned Contract at any time prior to the
date of entry of an order of the Bankruptcy Court authorizing and directing assumption
and assignment of such Additional Assigned Contract;

     1.1.7. All training, educational, and promotional materials related solely to the
Product, including without limitation advertising designs and copy, signs, videotapes,
brochures, infomercials, product literature, trade displays, posters and banners, and any
copyrights related thereto;

     1.1.8. The United States new drug application covering the Product, including any
supplements, amendments, or modifications thereto, or divisions thereof (the
“NDA”), submitted to or required by the United States Food and Drug
Administration (the “FDA”), Investigational New Drug Applications
(“INDs”) Nos. 53-908 and 60-132, and the foreign regulatory filings described on
Schedule 1.1.8 hereto, including all records and data related thereto in Seller’s
possession or control;

     1.1.9. All claims, judgments, choses in action or rights related solely to the
Product, including for past, present or future (a) infringement of patents licensed
pursuant to the License or infringement or dilution of any Trademarks licensed pursuant
to the License related solely to the Product, or (b) injury to the goodwill associated
with any Trademark or trademark registration licensed pursuant to the License related
solely to the Product (“Assigned Causes of Action”). Notwithstanding

2

 

the foregoing, claims and causes of action pursuant to §§542, 543,
544, 545, 547, 548, 549, 550, or 553 of the Bankruptcy Code shall not constitute Assigned
Causes of Action.

     1.2. Excluded Assets. The Purchased Assets shall not include any other assets of Seller,
including, but not limited to, the following (collectively, the “Excluded Assets”):

     1.2.1. All cash, cash equivalents, and securities on hand as of the Closing,
wherever located, including, without limitation, in accounts, lock boxes, and other
similar accounts (whether maintained at a bank, savings and loan, or other financial
institution);

     1.2.2. All income tax refunds or other tax refunds;

     1.2.3. All claims or causes of action (including pursuant to §§542, 543, 544, 545,
547, 548, 549, 550, or 553 of the Bankruptcy Code), other than Assigned Causes of Action;

     1.2.4. All contracts not related solely to the Product or not assumed by Buyer
pursuant to Section 1.1.6;

     1.2.5. All accounts receivable (including accounts receivable related to the
Product), intercompany claims, general intangibles, prepaid expenses, deposits, and other
current assets of Seller;

     1.2.6. All insurance policies and related claims and all proceeds of insurance
policies or related claims;

     1.2.7. All fixtures, furniture, and equipment, including office equipment, telephone
systems and computers, furniture, fixtures and leasehold improvements, office supplies,
and personal property not related to the Product, and other physical assets of Seller not
related to the Product;

     1.2.8. All Active Ingredient that, pursuant to Section 1.1.5, Buyer has identified
as not usable or salable.

     1.2.9. Antara® and all assets related solely to Antara®;

     1.2.10. Ramoplanin and all assets related solely to Ramoplanin; and

     1.2.11. Any economic interest in drug discovery or genomics alliances of Seller.

     1.3. Assumption of Certain Liabilities. At the Closing, or on the date of assumption and
assignment in the case of contracts designated for assumption and assignment pursuant to Section
1.1.6 for which Bankruptcy Court approval has not been obtained prior to the Closing Date, Buyer
will assume only the following liabilities of Seller relating to the Purchased Assets (the
“Assumed Liabilities”). Except as specifically described in this Section 1.3, Buyer shall
not

3

 

assume any liability or obligation of Seller whatsoever, whether or not any such liability or
obligation pertains to the Purchased Assets. Without limiting the foregoing, Buyer shall not
assume any liability for contract rejection damage claims for contracts that are not assumed by
Buyer.

     1.3.1. Buyer shall assume, under section 365(b)(1)(A) of the Bankruptcy Code, all
payment or performance obligations and related liabilities that arise after the Closing
under the Assigned Contract and Additional Assigned Contracts.

     1.3.2. Buyer shall assume any cure obligations with respect to the Assigned Contract
and Additional Assigned Contracts as provided herein, provided that Buyer, in its sole
discretion, may as provided herein elect to delete any contract from the designated list
of Additional Assigned Contracts to be assigned to Buyer and, in that event, shall not
assume any cure obligations in respect of such contract.

     1.3.3. Buyer shall assume all obligations of Seller with respect to shipments of the
Product that are returned on or after the Closing Date.

     1.4. Purchase Price. The consideration for the Purchased Assets (the “Purchase
Price”) shall be (a) a cash payment of Five Million Dollars ($5,000,000) plus the Inventory
Purchase Price (as defined below) (the “Closing Date Payment”), (b) the Purchase Royalty
Payments (as defined below), and (c) the assumption of the Assumed Liabilities. In accordance with
Section 2.2, at the Closing, the Buyer shall deliver the Assumption and Assignment Agreement (as
hereinafter defined) and deliver the Closing Date Payment by (i) the delivery of Four Million Five
Hundred Thousand Dollars ($4,500,000) plus the Inventory Purchase Price by wire transfer of
immediately available funds, or in such manner or form as may be mutually satisfactory; and (ii)
the delivery by the Escrow Agent (as hereinafter defined) to Seller of the Deposit (as hereinafter
defined).

     1.4.1. Inventory Purchase Price. At least two business days prior to the Closing
Date, representatives of Seller and Buyer shall meet to determine mutually in good faith
the number of units held as inventory by or on behalf of Seller of (a) the Active
Ingredient in the possession or control of Patheon Inc. that can be or is in the process
of being manufactured into the finished product form of the Product (“Finished
Product”) that Buyer elects to purchase pursuant to Section 1.1.5; (b) samples of
Finished Product (in quantities usable in the ordinary course of business) with at least
180 days of remaining shelf life from the Closing Date; and (c) all inventory of Finished
Product with at least 18 months of remaining shelf life from the Closing Date
(collectively, the “Closing Inventories”). The purchase price for the Closing
Inventories will be the aggregate of (i) the actual per unit purchase cost to Seller
(i.e., without overhead allocation) for each unit of each type of Closing Inventories,
multiplied by (ii) the number of units of each type of Closing Inventories (the
“Inventory Purchase Price”). To the extent that there are any material
differences in the amount of Closing Inventories as of the Closing Date from the amount
determined prior to the Closing Date, as determined mutually in good faith by
representatives of Seller and Buyer, the Seller and Buyer agree to make an appropriate
adjustment payable promptly following the Closing Date.

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     1.4.2. Purchase Royalty Payments.

	 	1.4.2.1.	 	From and after the Closing, Buyer shall pay to Seller a royalty
(the “Purchase Royalty Payments”) in an amount equal to fifteen
percent of (i) the gross amount invoiced for sales of the Product by
Buyer or its affiliates (or their licensees or sublicensees) to any
person other than Buyer or its affiliates (or their licensees or
sublicensees), less (ii) the following deductions from such gross
amounts which are actually incurred, allowed, accrued or specifically
allocated and to the extent such deductions are consistent with
generally accepted accounting principles in the United States and
normal practice in the ordinary course of business in connection with
the sale of the Product: (a) any invoiced freight, postage, shipping,
insurance and other transportation charges; (b) sales, value-added (to
the extent not refundable in accordance with applicable law), and
excise taxes, tariffs, or customs duties paid by Buyer and other
governmental charges imposed on the sale of the Product; (c) rebates,
chargebacks, or allowances (or the equivalent thereof) granted to group
purchasing organizations, managed health care organizations or to
federal, state/provincial, local and other governments, including their
agencies, or to trade customers; (d) trade, cash, quantity, or case
discounts; (e) allowances, price adjustments, or credits to customers,
not in excess of the selling price of the Product, on account of
governmental requirements, damaged Product, rejection, outdating,
recalls, or return of the Product; (f) Product vouchers and/or coupons
used for promotion; and (g) royalties payable to LGLS with respect to
Net Sales as such term is defined under the License (“Adjusted Net
Sales”).
	 
	 	1.4.2.2.	 	Buyer shall deliver to Seller, within 45 days after the end of each
calendar quarter, reasonably detailed written accountings of Adjusted
Net Sales that are subject to Purchase Royalty Payments due to Seller
for such calendar quarter. When Buyer delivers such reports to Seller,
Buyer shall also deliver Purchase Royalty Payments due to Seller
hereunder for such calendar quarter.
	 
	 	1.4.2.3.	 	Buyer shall keep, and shall require its affiliates (and their
licensees and sublicensees) to keep, complete and accurate records of
Adjusted Net Sales on which Purchase Royalty Payments are due
hereunder. For the purpose of verifying Purchase Royalty Payments due
to Seller hereunder, Seller shall have the right no more than once
annually, at Seller’s expense, to retain an independent certified
public accountant selected by Seller and reasonably acceptable to Buyer
to review such

5

 

	 	 	 	records in the location or locations such records are maintained
by Buyer and its affiliates (and their licencees and sublicensees)
upon reasonable notice during regular business hours and upon
execution of a confidential disclosure agreement with Buyer in
customary form. Each such review shall be limited to the records
covering the time period of 24 months prior to such review. The
results of such review shall be made available to both Buyer and
Seller. If the review reflects an underpayment of royalties to
Seller, Buyer shall promptly remit such underpayment to Seller,
together with interest at the overnight London Interbank Offered
Rate published by the British Bankers’ Association plus two
percent. If the underpayment of royalties is equal to or greater
than five percent of the Purchase Royalty Payments due with
respect to the period reviewed, then Buyer shall pay all of the
costs of such review. If there is an overpayment by Buyer for the
period reviewed, then Buyer may offset the overpayment amount
against future Purchase Royalty Payments, or, if Buyer is not
obligated to make any future payments to Seller, then Seller shall
promptly remit such overpayment to Buyer.
	 
	 	1.4.2.4.	 	Buyer’s obligation to make Purchase Royalty Payments pursuant to
Section 1.4.2 shall commence on the Closing Date and shall continue
with respect to Adjusted Net Sales through the fifth anniversary of the
Closing Date.

     1.4.3. Deposit. On the date hereof, Buyer shall make a cash deposit of $500,000
(the “Deposit”) by wire transfer to Ropes & Gray LLP (the “Escrow Agent”)
to be held in a non-interest bearing escrow account in accordance with the joint escrow
instructions attached hereto as Exhibit 1.4.3 and to be applied to the Closing
Date Payment, subject to the terms and conditions therein. Buyer and Seller consent to
the terms of these joint escrow instructions and agree to be bound thereby.

     1.4.4. Allocation of Purchase Price. The Purchase Price will be allocated to the
Purchased Assets as reasonably determined by Buyer within 30 days after the Closing Date,
provided that the allocation of the Purchase Price to Inventory shall equal the Inventory
Purchase Price, and Buyer shall promptly notify Seller of such allocation. In any event,
such allocation shall be in accordance with accounting principles generally accepted in
the United States. Seller agrees that such allocation shall be binding for tax reporting
purposes.

     1.5. Assigned Contract; Cure Payments. In connection with the Assigned Contract, Buyer shall
pay any cure payments related to liabilities that arise prior to the Closing that are required to
be paid in connection with such assumption and assignment. Seller has set forth a description of
the nature and amount of such cure payments expected to be required as of the Closing on
Schedule 1.1.6 hereto. As provided in the Assumption and Assignment Order, the

6

 

assumption and assignment of the Assigned Contract shall occur simultaneously at the Closing
hereunder.

     1.6. Additional Assigned Contracts; Cure Payments. In connection with any Additional Assigned
Contracts, Buyer shall pay any cure payments related to liabilities that arise prior to the date of
assumption and assignment of such Additional Assigned Contract that are required to be paid in
connection with such assumption and assignment. Seller has set forth a description of the nature
and amount of such cure payments expected to be required in connection with such assumption and
assignment on Schedule 1.1.6 hereto.

     1.7. Further Assurances. Each of the parties hereto, before, at, and after the Closing, upon
the request from time to time of the other party hereto and without further consideration, will do
each and every reasonable act and thing as may be necessary or reasonably desirable to consummate
the transactions contemplated hereby and to effect an orderly transfer to Buyer of the Purchased
Assets, including without limitation: executing, acknowledging, and delivering assurances,
assignments, powers of attorney, and other documents and instruments; obtaining the approval of the
Bankruptcy Court as promptly as practicable for the consummation of the transactions contemplated
hereby; obtaining any third party consents necessary to transfer any Purchased Assets; furnishing
information and copies of documents, books, and records; filing reports, returns, applications,
filings, and other documents and instruments with Governmental Bodies (as hereinafter defined); in
the case of Seller, turning over to Buyer all mail and communications related to the Purchased
Assets; and cooperating with the other party hereto (at such other party’s expense) in exercising
any right or pursuing any claim, whether by litigation or otherwise, other than rights and claims
running against the party from whom or which such cooperation is requested. If either party shall
receive any payment that pursuant to this Agreement is the property of the other party, then the
party receiving such payment shall promptly turn such payment over to the other party and until
such time shall hold it in trust for the other party.

     2. Closing; Deliveries.

     2.1. Closing. The closing of the transactions contemplated hereby (the “Closing”)
shall be held at the offices of Ropes & Gray LLP, counsel to Seller, One International Place,
Boston, Massachusetts at 10:00 a.m. on the first business day that is at least ten days after the
date of entry of the Sale Order (as defined below) or such other date as may be mutually
satisfactory to the parties, subject to satisfaction or waiver of the conditions set forth in
Sections 5 and 6 hereof (the date of the Closing being the “Closing Date”).

     2.2. Deliveries at Closing. At the Closing, (i) Buyer shall make the Closing Date Payment,
(ii) Seller shall deliver to Buyer the instruments of conveyance and other documents specified in
Section 5, and (iii) Buyer shall deliver to Seller the instruments of conveyance and other
documents specified in Section 6.

     2.3. Delivery of Purchased Assets by Seller. To the extent not already delivered to Buyer, as
soon as practicable following the Closing (and no more than fifteen days thereafter unless
otherwise mutually agreed by Seller and Buyer), Seller shall, at Buyer’s cost and expense, deliver
to Buyer all Purchased Assets in physical possession of Seller and shall instruct all third

7

 

parties that physically possess Purchased Assets to deliver such Purchased Assets to Buyer at
Buyer’s cost and expense. Seller shall, at Seller’s cost and expense, continue to bear the risk of
loss and maintain adequate insurance (or self-insurance) against loss associated with the Purchased
Assets until they have been delivered to Buyer or its common carrier. With respect to Trademarks
licensed pursuant to the License related solely to the Product owned by Seller, Seller shall
instruct its trademark counsel to deliver the original files and all other records of Seller or its
trademark counsel relating to the Trademarks to Smith, Anderson, Blount, Dorsett, Mitchell &
Jernigan, L.L.P., at the address provided in Section 9 of this Agreement, as soon as practicable
following the Closing (and no more than fifteen days thereafter unless otherwise mutually agreed by
Seller and Buyer). In addition, Seller shall destroy, without cost to Buyer, any Inventory not
usable or salable in the ordinary course of business related solely to the Product (other than
Active Ingredient that Buyer has identified as not usable or salable in accordance with Section
1.1.5) that is owned by Seller on the Closing Date and not delivered to Buyer pursuant to this
Agreement.

     3. Representations of Seller. Seller represents and warrants to Buyer as follows:

     3.1. Due Incorporation, Authorization, and Good Standing. Seller is a corporation duly
incorporated, validly existing, and in good standing under the laws of the State of Massachusetts,
and, subject to the approval of the Bankruptcy Court, has the requisite corporate power and
authority to enter into, execute, deliver, and perform this Agreement, any other agreements
relating to the transactions contemplated hereby, and any instruments of transfer and conveyance
(collectively, with this Agreement, the “Transaction Documents”) to which Seller is party,
and to consummate all transactions contemplated hereby and thereby and has taken all corporate
action required by law and its Articles of Organization and bylaws to authorize such execution,
delivery, and performance. This Agreement is, and each of the other Transaction Documents to which
Seller is a party will be, subject to the approval of the Bankruptcy Court and upon execution by a
duly authorized officer of Seller at the Closing, the valid and legally binding obligation of
Seller, enforceable against Seller in accordance with its terms, subject to bankruptcy, insolvency,
moratorium, reorganization, and similar laws of general applicability affecting the rights and
remedies of creditors and to general principles of equity, regardless of whether enforcement is
sought in proceedings in equity or at law.

     3.2. No Violation or Approval. The execution, delivery, and performance of this Agreement and
the other Transaction Documents to which Seller will be a party and the consummation of the
transactions contemplated hereby and thereby will not result in a breach or violation of, or a
default under, Seller’s Articles of Organization, bylaws, any statute applicable to it, any
agreement to which it is a party or by which it or any of its properties are bound, or any order,
judgment, decree, rule, or regulation of any federal, state, local, or foreign government or any
court, administrative or regulatory agency or commission, or other governmental authority or agency
having jurisdiction over it or its properties (“Governmental Body”). Except for the
approval of the Bankruptcy Court and filings to be made on or after the Closing Date in connection
with the Closing, no consent, approval, order, or authorization of, or declaration or filing with,
any Governmental Body is required of, and has not been obtained or made by, Seller in connection
with the execution and delivery of this Agreement and the other Transaction Documents or the
consummation of the transactions contemplated hereby and thereby.

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     3.3. Title to Assets. Seller has good title to all the Purchased Assets and at the Closing
will transfer the Purchased Assets to Buyer pursuant to section 363 of the Bankruptcy Code free and
clear of all liens, claims, encumbrances (“Liens”). Subject to Bankruptcy Court approval,
Seller has the complete and unrestricted power and right to transfer the Purchased Assets to Buyer
as contemplated by this Agreement.

     3.4. Brokers, Finders, Etc. Except for agreements with Broadpoint Capital, Inc., Seller has
not entered into any brokerage or other agreement contemplating commissions or other payments
payable upon sale of the Purchased Assets. All negotiations relating to this Agreement and the
transactions contemplated hereby have been carried on without the intervention of any person acting
on behalf of Seller in such manner as to give rise to any valid claim against Buyer for any
brokerage or finder’s commission, fee, or similar compensation.

     3.5. Trade Names and Trademarks. Listed on Schedule 1.1.1 are all Trademarks licensed
by Seller related solely to the Product that are registered or as to which registrations are
pending with the U.S. Patent and Trademark Office or any counterpart foreign trademark office.

     3.6. Patents. There are no patents or patent applications, relating solely to the Product,
owned, licensed to, or otherwise controlled by Seller or, to Seller’s knowledge, any of its current
or former employees or independent contractors other than the patents and patent applications
licensed to Seller pursuant to the License.

     3.7. SEC Filings. All registration statements, forms, reports, certifications, and other
documents filed by Seller with the Securities and Exchange Commission (the “SEC”) (the
“Seller SEC Documents”) did not at the time they were filed contain any untrue statement of
a material fact related to the Product or omit to state a material fact related to the Product
required to be stated in such Seller SEC Documents or necessary in order to make the statements
related to the Product in such Seller SEC Documents, in the light of the circumstances under which
they were made, not misleading. Seller has notified Buyer of all events and circumstances that
have occurred related to the Product, since Seller filed its last Annual Report on Form 10-K with
the SEC through the date hereof, that would require disclosure on an Annual Report on Form 10-K or
Quarterly Report on Form 10-Q if such report were required to be filed on the date hereof. Seller
has made available to Buyer copies of all comment letters received by Seller from the staff of the
SEC since January 1, 2007 and all responses to such comment letters by or on behalf of Seller that
relate to disclosure regarding the Product. As used in this Section 3.7, the term “file” shall be
broadly construed to include any manner in which a document or information is furnished, supplied,
or otherwise made available to the SEC.

     3.8. Legal Proceedings; Orders. Except as set forth on Schedule 3.8 and except for the
Bankruptcy Case and any other action, arbitration, investigation, litigation, or suit commenced,
brought, conducted, or heard by or before, or otherwise involving, any Governmental Body or
arbitrator (a “Proceeding”) that is not material, as of the date hereof, there is no
pending Proceeding that has been commenced by or against the Seller (a) relating to the Purchased
Assets or (b) that challenges, or that would have the effect of preventing, delaying, or making
illegal, any of the transactions contemplated hereby. Except as set forth on Schedule 3.8,
to Seller’s knowledge, as of the date hereof, there is no order issued by any Governmental Body
related to the Product or to Seller’s business in connection with the Product.

9

 

     3.9. Customer Inventory. The level of inventory of the Product in the possession of each of
Seller’s primary customers Cardinal and McKesson does not exceed the quantity equal to four times
the average monthly unit volume of sales made by Seller to each such customer with respect to the
Product (calculated over the immediately preceding twelve months), as evidenced by a recent
inventory report supplied by each such customer to Seller (the “Inventory Reports”).

     3.10. Disclaimer. Buyer acknowledges and agrees that, except as expressly provided in this
Agreement, the sale of the Purchased Assets shall be “as is and where is” and Seller makes no, and
hereby disclaims any, representation or warranty to Buyer with respect to the Purchased Assets or
the transactions contemplated hereby, including, without limitation, any warranty of
merchantability or fitness for a particular purpose. Without limiting the generality of the
foregoing, Seller makes no representation or warranty, express or implied, as to the validity or
utility of the Purchased Assets, the status of any issued patents or registered trademarks or any
applications for patents or trademarks, whether the Trademarks or any other intellectual property
or any use thereof infringes on the rights of others, or whether any license agreements or
contracts (other than the License at the Closing) are assignable. Further, there is no warranty as
to the condition of any tangible assets constituting Purchased Assets.

     4. Representations of Buyer. Buyer represents and warrants to Seller as follows:

     4.1. Due Incorporation, Authorization, and Good Standing. Buyer is a corporation duly
incorporated, validly existing and in good standing under the laws of the State of Nevada, and has
the requisite corporate power and authority to enter into, execute, deliver, and perform this
Agreement and the other Transaction Documents to which Buyer is a party and to consummate all
transactions contemplated hereby and thereby and has taken all action required by law and its
Articles of Incorporation and bylaws to authorize such execution, delivery, and performance. This
Agreement is, and each of the other Transaction Documents to which Buyer is a party, will, upon
execution thereof by a duly authorized officer of Buyer at the Closing, be the valid and legally
binding obligation of Buyer, enforceable against Buyer in accordance with its terms, subject to
bankruptcy, insolvency, moratorium, reorganization, and similar laws of general applicability
affecting the rights and remedies of creditors and to general principles of equity, regardless of
whether enforcement is sought in proceedings in equity or at law.

     4.2. No Violation or Approval. The execution, delivery, and performance of this Agreement and
the other Transaction Documents to which Buyer will be a party and the consummation of the
transactions contemplated hereby and thereby will not result in a breach or violation of, or a
default under, Buyer’s Articles of Incorporation, bylaws, any statute applicable to it, or any
order, judgment, decree, rule, or regulation of any Governmental Body. No consent, approval,
order, or authorization of, or declaration or filing with, any Governmental Body is required of,
and has not been obtained or made by, Buyer in connection with the execution and delivery of this
Agreement and the other Transaction Documents or the consummation of the transactions contemplated
hereby and thereby.

     4.3. Brokers, Finders, etc. All negotiations relating to this Agreement and the transactions
contemplated hereby have been carried on without the intervention of any person acting on behalf of
Buyer in such manner as to give rise to any valid claim against Seller or Buyer for any brokerage
or finder’s commission, fee, or similar compensation.

10

 

     5. Conditions Precedent to the Obligations of Buyer. The obligations of Buyer to
purchase the Purchased Assets and to consummate the other transactions contemplated hereby and by
the other Transaction Documents are subject to the satisfaction on or prior to the Closing Date of
each of the following conditions, unless expressly waived by Buyer at or prior to the Closing:

     5.1. Representations and Warranties. The representations and warranties made by Seller in
this Agreement (including the Exhibits and Schedules hereto) shall be true and correct in all
material respects on and as of the Closing Date with the same force and effect as if made on and as
of the Closing Date, except for those representations and warranties that address matters only as
of a particular date (which shall be true and correct as of such date).

     5.2. Seller’s Performance. All of the covenants and agreements that Seller is required to
perform or to comply with pursuant to this Agreement at or prior to the Closing must have been duly
performed and complied with in all material respects.

     5.3. Bill of Sale, Assignment and Assumption Agreement. Seller shall have executed and
delivered a bill of sale (“Bill of Sale”) in the form attached hereto as Exhibit
5.3(a) and an assignment and assumption agreement (“Assignment and Assumption
Agreement”) in the form attached hereto as Exhibit 5.3(b) conveying to Buyer all of the
Purchased Assets and transferring to Buyer the Assigned Contract.

     5.4. Domain Names. Seller shall have executed and delivered to Buyer appropriate assignment
instruments for all domain names included in the Purchased Assets.

     5.5. Letter to FDA. Seller shall have delivered to Buyer a letter from Seller to the FDA,
duly executed by Seller, transferring the rights to the NDA and the INDs to Buyer, in a form
reasonably satisfactory to Buyer.

     5.6. Letter to DDMAC. Seller shall have delivered to Buyer a letter from Seller to the FDA,
Division of Drug Marketing, Advertising and Communication, duly executed by Seller, notifying of
the transfer of the NDA and the INDs to Buyer.

     5.7. Bidding Procedures Order. The Bankruptcy Court shall have held a hearing (the
“Bidding Procedures Hearing”) and shall have entered a final non-appealable order in the
Bankruptcy Case approving procedures for solicitation and consideration by the Bankruptcy Court of
bids from third parties for the Purchased Assets (the “Bidding Procedures Order”), which
Bidding Procedures Order shall be in form and substance reasonably satisfactory to Seller and Buyer
and shall provide, among other things, that:

     5.7.1. in the event that the Bankruptcy Court fails to approve (i) the Sale Motion
(as hereinafter defined) or (ii) a sale to Buyer as provided hereunder and instead
approves a sale of some or all of the Purchased Assets to an entity that has submitted a
Counteroffer (as hereinafter defined), and such sale closes, Seller shall pay to Buyer,
without further order of the Bankruptcy Court, the lesser of (a) $75,000 and (b) Buyer’s
actual expenses incurred in connection with the transactions contemplated hereby,
including expenses of counsel and other consultants (the “Expense
Reimbursement”);

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     5.7.2. in the event that the Bankruptcy Court fails to approve a sale to Buyer as
provided hereunder and instead approves a sale of some or all of the Purchased Assets to
an entity that has submitted a Counteroffer, and such sale closes, Seller shall pay to
Buyer, without further order of the Bankruptcy Court, the lesser of (a) $100,000 and (b)
35% of the excess of the amount of (i) the Counteroffer over (ii) the Purchase Price plus
$175,000 (the “Break-Up Fee”);

     5.7.3. if Buyer elects to participate in bidding at the Sale Hearing (as hereinafter
defined), Buyer may credit the Expense Reimbursement and Break-Up Fee towards its bid;

     5.7.4. the initial bid at the Sale Hearing must be at a purchase price with a
minimum cash component payable at closing of $5,275,000 plus the Inventory Purchase
Price;

     5.7.5. each subsequent bid must be at least $100,000 greater than the preceding bid;

     5.7.6. each bidder must make a $500,000 cash deposit on the same terms as the Buyer
as provided herein;

     5.7.7. each bid must be irrevocable until the closing of the sale;

     5.7.8. each bidder must demonstrate to Seller’s satisfaction in its reasonable
discretion that the bidder is (a) financially able to consummate the transaction
contemplated by such bid, which ability may be demonstrated by submission of current
audited or unaudited financial statements or other reasonable evidence, or, if the bidder
is an entity formed for the purpose of acquiring the Purchased Assets, current audited or
unaudited financial statements or other reasonable evidence of the equity holders of the
bidder, and (b) able to consummate the transaction on the date and on the terms
contemplated by the asset purchase agreement submitted with such bid;

     5.7.9. the terms and conditions of each bid must be, in aggregate, not materially
more burdensome to Seller than the terms and conditions contained herein as determined by
Seller in its sole discretion exercised in good faith and cannot be conditioned on the
outcome of unperformed due diligence by the bidder, material adverse change provisions,
and/or obtaining financing; and

     5.7.10. Seller may not modify the foregoing procedures without further order of the
Bankruptcy Court.

     5.8. Notice of Sale. Seller shall have served a copy of a notice of the sale and assumption
and assignment of the Assigned Contract and Additional Assigned Contracts upon (i) the Office of
the United States Trustee for the District of Massachusetts, Eastern Division; (ii) counsel to Paul
Royalty Fund Holdings II, LP; (iii) the Indenture Trustees for the Seller’s Second Lien and
Unsecured Notes, or their counsel; (iv) the creditors holding the 30 largest unsecured claims
against the Seller’s estate; (v) all parties known to have asserted Liens against the

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Purchased Assets; (vi) federal and state taxing authorities’ offices which have a reasonably
known interest in the relief requested in the Bankruptcy Case; (vii) counsel to the Buyer; (viii)
all entities reasonably known to have asserted any interest in or expressed an interest in a
transaction with respect to the Purchased Assets within the last twelve months; (ix) all parties to
the Assigned Contract and Additional Assigned Contracts; and (x) all parties who have filed notices
of appearance requesting service of notice and pleadings and all other persons required to receive
notice of the sale pursuant to Rule 2002 of the Federal Rules of Bankruptcy Procedure (the
“Bankruptcy Rules”). Seller shall have filed a certificate of such service (the
“Certificate of Service”) with the Bankruptcy Court in the Bankruptcy Case.

     5.9. Sale Order. The Bankruptcy Court shall have entered an order in the Bankruptcy Case in
form and substance reasonably satisfactory to Seller and Buyer (i) approving the sale, transfer,
assignment, and assumption, as appropriate, of the Purchased Assets to Buyer upon the terms and
conditions set forth herein, free and clear of any and all Liens of any kind or nature whatsoever;
(ii) providing that any and all valid Liens shall attach to the Purchase Price at Closing; and
(iii) containing findings that all applicable notice and hearing requirements for the transactions
contemplated hereby under the Bankruptcy Code, Bankruptcy Rules, and any local rules of the
Bankruptcy Court have been satisfied, the transactions contemplated hereby are in the best
interests of Seller’s estate and creditors in the Bankruptcy Case, and Buyer is a good faith
purchaser pursuant to Section 363(m) of the Bankruptcy Code (the “Sale Order”).

     5.10. Assumption and Assignment Order. The Bankruptcy Court shall have entered an order in
the Bankruptcy Case independently or in conjunction with the Sale Order approving assumption of the
Assigned Contract in accordance with section 365(b) of the Bankruptcy Code and assignment thereof
to Buyer as of the Closing, which order shall provide that all defaults under the Assigned Contract
shall have been cured and specify that the amount of all cure payments owed under the Assigned
Contract that must be paid is no more than the lesser of (i) 10% or (ii) $100,000 greater than the
amount set forth on Schedule 1.1.6 hereto (the “Assigned Contract Cure Limit”)
(unless Seller has undertaken to, and does, pay or make provisions for payment of cure amounts in
excess of the Assigned Contract Cure Limit at or prior to Closing), and otherwise be in form and
substance acceptable to Seller and Buyer (the “Assumption and Assignment Order”). Buyer
covenants and agrees to use commercially reasonable efforts to provide sufficient evidence of
adequate assurance of future performance under the Assigned Contract to satisfy requirements under
the Bankruptcy Code for assumption and assignment of the Assigned Contract.

     5.11. Final Orders. On the Closing Date, the Sale Order and the Assumption and Assignment
Order shall be final orders which have not been rescinded, reversed, modified, or stayed, and shall
be in full force and effect.

     5.12. Third Party Consents. Solely to the extent that the Sale Order is legally insufficient
to transfer the Purchased Assets without consent of third parties, all consents, waivers, or
approvals required to be obtained by Seller in order to transfer any Purchased Assets (other than
the Additional Assigned Contracts) or consummate the transactions contemplated hereby shall have
been obtained and shall be in full force and effect and in forms reasonably satisfactory to Buyer.

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     5.13. Officer’s Certificate. There shall have been delivered to Buyer a certificate, dated
the Closing Date and executed by Seller’s Chief Executive Officer or Chief Financial Officer on
behalf of Seller, certifying as to the satisfaction of the conditions set forth in Sections 5.1 and
5.2 hereof.

     5.14. Secretary’s Certificate. There shall have been delivered to Buyer a certificate, dated
the Closing Date and executed on behalf of Seller by Seller’s Secretary, certifying as to the
accuracy of, and attaching copies of, Seller’s Articles of Organization, bylaws, and all
resolutions of Seller’s Board of Directors approving the execution and delivery of the Transaction
Documents and the consummation of the transactions contemplated thereby.

     5.15. Certified Copies. There shall have been delivered to Buyer certified copies of the Sale
Order, the Assumption and Assignment Order, and the Certificate of Service entered or filed in the
Bankruptcy Case, as well as a certified copy of the docket of the Bankruptcy Case.

     5.16. No Injunction. There must not be in effect any applicable law, rule, or regulation or
any injunction or other order issued by any Governmental Body that (a) prohibits consummation of
any of the transactions contemplated hereby, and (b) has been adopted or issued, or has otherwise
become effective, since the date of this Agreement.

     5.17. General. All instruments and legal and corporate proceedings in connection with the
transactions contemplated hereby and by the other Transaction Documents shall be reasonably
satisfactory in form and substance to Buyer, and Buyer shall have received counterpart originals,
or certified or other copies, of all documents, including without limitation records of corporate
proceedings, that it may reasonably request in connection therewith.

     6. Conditions Precedent to Obligations of Seller. Seller’s obligations to sell the
Purchased Assets to Buyer and to consummate the other transactions contemplated hereby and by the
other Transaction Documents are subject to the satisfaction on or prior to the Closing Date of each
of the following conditions, unless expressly waived by Seller at or prior to the Closing:

     6.1. Representations and Warranties. The representations and warranties made by Buyer in this
Agreement shall be true and correct in all material respects on and as of the Closing Date with the
same force and effect as if made on and as of the Closing Date, except for those representations
and warranties that address matters only as of a particular date (which shall be true and correct
as of such date).

     6.2. Buyer’s Performance. All of the covenants and obligations that Buyer is required to
perform or to comply with pursuant to this Agreement at or prior to the Closing must have been
performed and complied with in all material respects.

     6.3. Payment Acknowledgment, Assignment and Assumption Agreement. Buyer shall have executed
and delivered the Assignment and Assumption Agreement and shall have made the Closing Date Payment.

     6.4. Letter to FDA. Buyer shall have delivered to Seller a letter from Buyer to the FDA, duly
executed by Buyer, assuming responsibility for the NDA and the INDs from Seller, in a form
reasonably satisfactory to Seller.

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     6.5. Bankruptcy Court Approval. The Bankruptcy Court shall have entered the Sale Order and
Assumption and Assignment Order, and such orders shall not have been rescinded, reversed, modified,
or stayed, and shall be in full force and effect.

     6.6. Officer’s Certificate. There shall have been delivered to Seller a certificate, dated
the Closing Date and executed by Buyer’s Chief Executive Officer or Chief Financial Officer on
behalf of Buyer, certifying as to the satisfaction of the conditions set forth in Sections 6.1 and
6.2 hereof.

     6.7. Secretary’s Certificate. There shall have been delivered to Seller a certificate, dated
the Closing Date and executed by Buyer’s Secretary on behalf of Buyer, certifying as to the
accuracy of, and attaching copies of, Buyer’s Articles of Incorporation, bylaws, and all
resolutions of Buyer’s Board of Directors approving the execution and delivery of the Transaction
Documents and the consummation of the transactions contemplated thereby.

     6.8. General. All instruments and legal and corporate proceedings in connection with the
transactions contemplated hereby and by the other Transaction Documents shall be reasonably
satisfactory in form and substance to Seller, and Seller shall have received counterpart originals,
or certified or other copies, of all documents, including without limitation records of corporate
proceedings, that it may reasonably request in connection therewith.

     7. Covenants of the Parties.

     7.1. Access to Premises, Information, and Contracting Parties.

     7.1.1. From and after the date hereof, through the Closing Date, Seller will permit
Buyer and its authorized representatives to have reasonable access during normal
operating hours to Records in possession of Seller that reasonably relate to the Product.
In addition, prior to the Closing Date Seller will permit authorized representatives and
professionals of Buyer reasonable access during normal operating hours to all management
personnel, offices, and books and records of Seller related to the Product, and Buyer
shall (at its expense) be permitted to make abstracts from, or copies of, all such books
and records. Seller shall promptly deliver to Buyer all Inventory Reports received from
Cardinal and McKesson and, promptly upon Buyer’s request from time to time, a report of
all inventory shipped to Cardinal and McKesson since the date of the last Inventory
Report delivered to Buyer for such customer. Seller shall reasonably cooperate with
Buyer to assist Buyer to contact counterparties to Seller’s contracts related to the
Product, including manufacturers, packagers, and licensors.

     7.1.2. From and after the Closing until the wind down of Seller’s business
operations, each party agrees to cooperate with and to grant to each other party and
their authorized representatives, during normal business hours, reasonable access to the
other party’s management personnel and such other information and records relating to the
Product and the Purchased Assets in their possession after the Closing and to permit
copying or, where reasonably necessary, to furnish original documents relating to the
Products and the Purchased Assets for the purposes of (i) any

15

 

financial reporting or tax matters (including without limitation any financial and
tax audits, tax contests, tax examination, preparation for any tax returns or financial
records); (ii) any regulatory reporting matters; (iii) any investigation being conducted
by any Governmental Body involving the Products, the Purchased Assets, or any individuals
employed by Seller prior to the Closing Date; (iv) any claims or litigation involving
either party, the Purchased Assets, or any individuals employed by Seller prior to the
Closing Date; or (v) any similar or related matter. Each party shall use commercially
reasonable efforts to ensure that its access to and requests for records and documents
pursuant to this Section 7.1.2 are conducted so as not to interfere with the normal and
ordinary operation of the other party’s business. Each party acknowledges that the
records and documents made available to such party pursuant to this Section 7.1.2
constitute Confidential Information of the releasing party that is subject to the
provisions of Section 7.3 hereof.

     7.1.3. Notwithstanding anything to the contrary contained in this Agreement, Seller
may retain and use archival copies of all documents or materials conveyed hereunder to
the extent (i) required to remain in the possession of Seller pursuant to any applicable
law, (ii) related to any of the specified purposes set forth in Section 7.1.2, or (iii)
necessary or appropriate for Seller to perform and discharge all of its liabilities or
obligations that do not constitute Assumed Liabilities; provided that Seller shall
maintain such items in accordance with the provisions of Section 7.3 hereof.

     7.2. Preservation of Assets Prior to Transfer of Purchased Assets. Prior to the transfer of
the Purchased Assets to Buyer, Seller will not (a) license, sell, lease, or otherwise dispose of or
enter into any contract for the license, sale, lease, or other disposition of any Purchased Asset
to any person or entity other than sales of the Product in the ordinary course of business; (b)
amend, terminate, or modify any material contracts, licenses, registrations, or applications of or
related to the Trademarks or the Product; or (c) allow the levels of Active Ingredient, samples of
Finished Product, or Finished Product included in Inventory to vary materially from the levels
customarily maintained. Seller will operate its business with respect to the Product in the usual,
regular, and ordinary course of business in all material respects (it being understood that such
usual, regular, and ordinary course may take into account the fact that the business is being
operated while in bankruptcy and without a sales force marketing the Product).

     7.3. Confidential Information.

     7.3.1. Each party agrees that it will treat in confidence all documents, materials,
and other information obtained (whether obtained before or after the date of this
Agreement) regarding the other party during the course of the negotiations of the
transactions contemplated hereby and the preparation of this Agreement, the Transaction
Documents, and other related documents (“Confidential Information”).
Confidential Information shall not be communicated to any third person (other than to
each party’s respective counsel, accountants, financial advisors, and investors and other
necessary parties on a “need to know” basis only). No party shall use any Confidential
Information in any manner whatsoever except solely for the negotiations of the
transactions contemplated hereby and the purposes of this Agreement; provided,

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however, that (a) the parties may disclose this Agreement and its terms as necessary
to file the Sale Motion and related motions, to comply with the Bidding Procedures Order,
the Sale Order, and related orders, and to market the Purchased Assets to other bidders,
and (b) after the Closing, Buyer may use or disclose any Confidential Information
included in the Purchased Assets. In the event that the transactions contemplated hereby
are not consummated, each party will return all copies of Confidential Information to the
other party. Notwithstanding the foregoing, the obligation of each party to treat
Confidential Information in confidence shall not include any information which (a) is or
becomes available to such party from a source other than the other party; (b) is or
becomes available to the public other than as a result of disclosure by such party or its
agents; (c) upon advice of counsel, is required to be disclosed under applicable law
(including, without limitation, the Bankruptcy Code) or judicial process, but only to the
extent it must be disclosed; or (d) is reasonably deemed necessary by such party to
disclose to obtain any of the consents or approvals contemplated hereby.

     7.3.2. If the transactions contemplated hereby are consummated, (i) all Confidential
Information relating solely to the Purchased Assets shall be deemed to be information
received in confidence from Buyer, and not to already have been known by Seller, for
purposes of this Section 7.3 and shall be held in confidence by Seller and its affiliates
after the Closing Date pursuant to the requirements set forth in Section 7.3.1, and (ii) all
Confidential Information relating in part to the Purchased Assets shall not be used by
Seller or its affiliates to the detriment of Buyer and shall be maintained in confidence
after the Closing Date by Seller and its affiliates in the same manner as Seller and its
affiliates treat their other confidential information.

     7.4. Notification. Between the date of this Agreement and the Closing Date, Seller will
respond to inquiries from Buyer concerning the status of the business and operations of Seller
related to the Product and use commercially reasonable efforts to inform Buyer in writing within
five business days after obtaining knowledge of (i) any events or circumstances that materially
affect Seller’s business related to the Product or the Purchased Assets, or (ii) any breach in any
material respect by Seller of any representation, warranty, covenant, or agreement hereunder.

     7.5. No Public Announcement. Except as provided herein, neither Seller nor Buyer shall,
without the approval of the other, which approval shall not be unreasonably withheld, make any
press release or other public announcement regarding the transactions contemplated by this
Agreement, except as and to the extent that any such party is so obligated by applicable law, in
which case the other party shall be advised and the parties shall use their best efforts to cause a
mutually agreeable release or announcement to be issued; provided that the foregoing shall not
preclude communications or disclosures necessary to (i) implement the provisions of this Agreement;
or (ii) comply with accounting obligations or applicable law (including, without limitation, the
Bankruptcy Code) or judicial process.

     7.6. Use of Seller Trade Dress. As of the Closing Date, Seller (or its affiliate) hereby
grants to Buyer and its affiliates, and Buyer hereby accepts, a non-exclusive, non-transferable,
non-sublicensable, royalty-free license in the United States of America (including all territories,

17

 

protectorates, the District of Columbia, and the Commonwealth of Puerto Rico) to use (i) the
trademarks, tradenames, brands, corporate names, or similar items used by Seller or any of Seller’s
affiliates, other than the Trademarks, and (ii) the layout, designs, and coloring used on the
packaging of the Product to the extent used on other product packaging of Seller or any of Seller’s
affiliates (collectively, the “Seller Trade Dress”), solely to the extent necessary to
allow Buyer to (a) distribute the inventories of Finished Product and samples of Finished Product
included in the Purchased Assets; (b) use the training, educational, and promotional materials
included in the Purchased Assets; and (c) otherwise perform its obligations under this Agreement
and the other Transaction Documents (the “Seller Trade Dress License”). Buyer acknowledges
that the Seller Trade Dress License is being granted solely for transitional purposes and that
Buyer shall use commercially reasonable efforts to cease its use of the Seller Trade Dress as
quickly as is reasonably possible after the Closing Date. Notwithstanding the foregoing, the
Seller Trade Dress License will terminate (i) with respect to training, educational, and
promotional materials containing the Seller Trade Dress, 30 business days after the date upon which
Buyer receives notice from the FDA that Buyer’s training, educational, and promotional materials
for the Product that do not refer to the Seller Trade Dress have been pre-cleared by the FDA
pursuant to 21 CFR 314 Subpart H, and (ii) with respect to packaging and labeling of the Product
containing Seller Trade Dress, on the later of exhaustion of any Inventory labeled with Seller
Trade Dress or six months following receipt by Buyer of labeling approval for the Product from the
FDA.

     7.7. Product Responsibility.

     7.7.1. From and after the Closing, Buyer shall be responsible for (i) taking all
actions, paying all fees, and conducting all communication with the appropriate
Governmental Body required by applicable legal requirements in respect of the Product,
including preparing and filing all reports (including adverse drug experience reports)
with the appropriate Governmental Body; (ii) taking all actions and conducting all
communication with third parties in respect of the Product (whether sold before or after
the Closing), including responding to all complaints in respect thereof, including
complaints related to tampering or contamination; and (iii) investigating all complaints
and adverse drug experiences in respect of the Product (whether sold before or after the
Closing).

     7.7.2. Promptly after the Closing, Buyer and Seller shall cooperate to transfer
responsibility to Buyer for the servicing of customer complaints, notifications of
adverse drug experiences in respect of the Product, returns, and other customer issues,
including contracts related to maintenance of toll-free customer service numbers.

     7.7.3. From and after the Closing until 30 days after the Closing Date, Seller shall
promptly notify Buyer if Seller receives a complaint or a report of an adverse drug
experience in respect of the Product. In addition, Seller shall cooperate with Buyer’s
reasonable requests and use commercially reasonable efforts to assist Buyer in connection
with the investigation of and response to any complaint or adverse drug experience
related to a Product sold by Seller.

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     7.7.4. From and after the Closing, Buyer shall be responsible for conducting,
handling, or processing (i) all voluntary and involuntary recalls of units of Product,
including recalls required by any Governmental Body, and (ii) all returns and credits
with respect to the Product (except as provided in Section 7.7.5 below), in each case,
regardless of whether such Product was sold before or after the Closing.

     7.7.5. From and after the Closing Date, Buyer shall be responsible for returned
Product. From and after the Closing until 30 days after the Closing Date, Seller shall
forward to Buyer any communications in respect of returned Product. Seller shall destroy
returned product and any Inventory not usable or salable in the ordinary course of
business (other than Active Ingredient that Buyer has identified as not usable or salable
in accordance with Section 1.1.5) at Seller’s expense and in accordance with Seller’s
customary practices.

     7.7.6. As soon as practicable following the Closing Date, Buyer shall institute
appropriate procedures (including any appropriate procedures for tracking of lot number
information) to ensure that the Product sold by or on behalf of Buyer can be
distinguished from the Product sold by or on behalf of Seller.

     7.7.7. As soon as practicable following the Closing Date, Buyer will establish a new
national drug code (“NDC”) number for the Product and thereafter shall cause such
NDC number to be used on the labeling and packaging for Product manufactured after
receipt of the new NDC number.

     7.8. Notification to Customers. Promptly following the Closing Date, Seller shall issue a
letter to customers within the trade (wholesalers and distributors) notifying such customers that
all future Product orders are to be placed with Buyer and that all returns of Product are to be
delivered to Buyer and shall be the responsibility of Buyer, and providing the appropriate contact
information for Buyer’s personnel.

     8. Conduct of Auction and Closing of Sale.

     8.1. Sale Hearing, Competing Bids, Etc.

     8.1.1. Buyer acknowledges that in connection with the sale of the Purchased Assets,
Seller shall have advertised to the public, in a commercially reasonable manner as
required by the Bankruptcy Code and as shall be directed by the Bankruptcy Court in the
Bidding Procedures Order, that the Purchased Assets are for sale and will be sold to the
highest or best bidder at a hearing to be conducted in the Bankruptcy Case (the “Sale
Hearing”). Buyer shall be entitled to submit further bids at the Sale Hearing,
consistent with the terms herein, in the event that a higher or better offer than that
reflected herein is received by Seller. In the event that the highest or best offer, as
determined by the Bankruptcy Court, is submitted at the Sale Hearing by a purchaser other
than Buyer, then Seller shall be entitled to close a sale pursuant to such other offer
(or, if such other offer does not close, then pursuant to the next highest or best offer)
and this Agreement shall be considered null and void; provided that the Deposit shall
remain in escrow until the earlier of five days after the Sale Hearing and

19

 

the closing date of the sale to a purchaser other than Buyer, after which it shall
be returned to Buyer. In the event that a purchaser other than Buyer (for purposes of
this sentence only, the “Alternate Purchaser”) is determined to have submitted
the highest and best offer, and such offer does not timely close, Buyer agrees to
purchase the Purchased Assets at the last offer submitted by Buyer at the Sale Hearing
that was higher and better than any offer made by a third party bidder other than the
Alternate Purchaser and otherwise upon the terms and conditions herein.

     8.1.2. Any counteroffer or bid for any of the Purchased Assets (a
“Counteroffer”) shall comply with all of the following requirements, provided
that Seller may, in its sole discretion, waive any requirements other than requirements
specified in Section 5.7 hereof. Any such bid shall be:

	 	8.1.2.1.	 	filed with the Bankruptcy Court on or before 12:00 noon on the
third business day prior to the scheduled date of the Sale Hearing (the
“Bidding Deadline”), with a copy delivered so that it is
actually received by counsel for Seller, James M. Wilton, Ropes & Gray
LLP, One International Place, Boston, MA 02110-2624, Telecopy:
617-951-7050 and counsel to Buyer, David B. Clement, Smith, Anderson,
Blount, Dorsett, Mitchell & Jernigan, L.L.P., 2500 Wachovia Capitol
Center, Post Office Box 2611, Raleigh, NC 27602-2611, Telecopy:
919-821-6800 before the Bidding Deadline;
	 
	 	8.1.2.2.	 	accompanied by (a) a cash deposit with counsel to Seller (to be
received on or before the last business day prior to the scheduled date
of the Sale Hearing) equal to $500,000, and (b) a duly executed,
signed, detailed asset purchase agreement on terms in aggregate not
materially more burdensome to Seller than provisions contained herein
as determined by Seller in its sole discretion exercised in good faith,
provided that (x) the bidder shall be substituted for Buyer and (y) the
purchase price shall have a cash component payable at closing in an
amount not less than $5,275,000 plus the Inventory Purchase Price; and
	 
	 	8.1.2.3.	 	accompanied by evidence of such bidder’s financial ability to
consummate the transaction on the date and on the terms contemplated by
the asset purchase agreement to the Seller’s satisfaction in its
reasonable discretion, which ability may be demonstrated by submission
of current audited or unaudited financial statements or other
reasonable evidence, or, if the bidder is an entity formed for the
purpose of acquiring the Purchased Assets, current audited or unaudited
financial statements or other reasonable evidence of the equity holders
of the bidder.

20

 

     8.2. Seller’s Motions in Bankruptcy Court. Within five business days after the date of
commencement of the Bankruptcy Case (the “Petition Date”), Seller will move the Bankruptcy
Court (i) to enter the Sale Order and the Bidding Procedures Order, (ii) to schedule the Bidding
Procedures Hearing on a date no later than 30 days after the Petition Date, and (iii) to schedule
the Sale Hearing on a date no later than 60 days following the filing of the motion to approve the
Sale Order (the “Sale Motion”).

     8.3. Preparation for Closing. Each of the parties hereto agrees to use its good faith efforts
to bring about the fulfillment of the conditions precedent contained in this Agreement, including
without limitation the obtaining of all necessary consents, approvals, and waivers for the
consummation of the transactions contemplated hereby.

     8.4. Cooperation. Buyer and Seller agree to cooperate with one another in good faith with
respect to any discussions Buyer may have with any customers, vendors, former employees, or others
having (or formerly having) business relationships with Seller with respect to the Product.

     8.5. Defense of Orders. Buyer, with cooperation of Seller, and at Buyer’s sole cost and
expense, shall defend any appeal of the Sale Order and the Assumption and Assignment Order in the
event that the Sale Order fails to provide for findings of Buyer’s good faith under section 363(m)
of the Bankruptcy Code, Buyer has waived the requirement of this finding in the Sale Order as a
condition to Closing, and the Closing has occurred as provided hereunder. In all other cases,
Seller, with the cooperation of Buyer, shall defend any appeal of the Sale Order and the Assumption
and Assignment Order in the event that the Closing has occurred as provided hereunder, and Buyer
and Seller shall each pay one half of the cost of such defense.

     8.6. Additional Assigned Contracts. Seller will use its good faith efforts to obtain the
entry of an order or orders of the Bankruptcy Court authorizing assumption and assignment of any
Additional Assigned Contracts that are not covered by the Sale Order or Assumption and Assignment
Order as soon after the Sale Hearing as is practicable, and Buyer shall be responsible for all
costs associated with curing any and all defaults under such contracts required to be cured as a
condition of Buyer’s assumption thereof.

     9. Notices. All notices, demands, consents or other communications which any party
may be required or may desire to give under this Agreement shall be in writing and shall be deemed
to have been duly given (i) upon receipt if mailed by certified mail, return receipt requested,
postage prepaid, (ii) one business day after prepaid deposit with a reputable overnight delivery
service, or (iii) upon receipt if delivered by telecopy or email, the receipt by sender of telecopy
confirmation or of recipient’s email acknowledgment of receipt being conclusive evidence of such
receipt, in any case to the party to whom the same is so given or made at the address of such party
as set forth below:

	 	 	 
	To Seller:

	 	Oscient Pharmaceuticals Corporation
	 

	 	1000 Winter Street
	 

	 	Suite 2200
	 

	 	Waltham, MA 02451
	 

	 	Telecopier: (781) 893-9535

21

 

	 	 	 
	 

	 	Email: srauscher@oscient.com
	 

	 	Attn: Stephen Rauscher
	 
	 	 
	     with a copy to

	 	Ropes & Gray LLP
	     (which shall not

	 	One International Place
	     constitute notice):

	 	Boston, MA 02110
	 

	 	Telecopier: (617) 951-7050
	 

	 	Email: james.wilton@ropesgray.com
	 

	 	Attn: James M. Wilton, Esq.
	 
	 	 
	To Buyer:

	 	Cornerstone BioPharma, Inc.
	 

	 	1255 Crescent Green Drive
	 

	 	Suite 250
	 

	 	Cary, NC 27518
	 

	 	Telecopier: (919) 678-6599
	 

	 	Email: David.Price@crtx.com
	 

	 	Attn: David Price
	 
	 	 
	     with a copy to

	 	Smith, Anderson, Blount, Dorsett,
	     (which shall not

	 	Mitchell & Jernigan, L.L.P.
	     constitute notice):

	 	2500 Wachovia Capitol Center
	 

	 	Post Office Box 2611
	 

	 	Raleigh, NC 27602-2611
	 

	 	Telecopier: (919) 821-6800
	 

	 	Email: dclement@smithlaw.com
	 

	 	Attn: David B. Clement

     10. Termination.

     10.1. Termination Events. This Agreement may be terminated by Buyer or Seller by giving
written notice to the other party as follows:

     10.1.1. by Buyer at any time after five business days following the date hereof, if
Seller has not commenced the Bankruptcy Case on or before such date;

     10.1.2. by Buyer at any time after five business days following the Petition Date,
if Seller has not filed the Sale Motion with the Bankruptcy Court on or before such date;

     10.1.3. by Buyer or Seller at any time after 30 days following the Petition Date, if
the Bidding Procedures Order is not entered on or before such date;

     10.1.4. by Buyer or Seller at any time after 55 days following the Petition Date, if
the Sale Order has not been entered on or before such date;

22

 

     10.1.5. by Buyer at any time after three days following the entry of the Sale Order,
if the Closing has not occurred for any reason other than Buyer’s material breach of its
obligations hereunder; and

     10.1.6. by Seller if the Closing has not occurred as a result of Buyer’s material
breach of its obligations hereunder.

     10.2. Effect of Termination. Each party’s right of termination under Section 10.1 is in
addition to any other rights it may have under this Agreement, and the exercise of a right of
termination will not be an election of remedies. If this Agreement is terminated pursuant to
Section 10.1, all further obligations of the parties under this Agreement will terminate, except
that (a) Seller shall be obligated to pay Buyer the Expense Reimbursement Fee and Break-Up Fee
described in Sections 5.7.1 and 5.7.2, if applicable, and (b) the obligations in Sections 7.3, 7.5,
9, 11, 12, and 16, the joint escrow instructions, and Seller’s entitlement to the Deposit in the
event of Buyer’s material breach of its obligations hereunder will survive.

     11. Waiver. The rights and remedies of the parties to this Agreement are cumulative
and not alternative. Neither the failure nor any delay by any party in exercising any right,
power, or privilege under this Agreement, the Transaction Documents, or the other documents
referred to herein will operate as a waiver of such right, power, or privilege, and no single or
partial exercise of any such right, power, or privilege will preclude any other or further exercise
of such right, power, or privilege or the exercise of any other right, power, or privilege. To the
maximum extent permitted by applicable law, (a) no claim or right arising out of this Agreement,
the Transaction Documents, or the other documents referred to herein can be discharged by one
party, in whole or in part, by a waiver or renunciation of the claim or right unless in writing
signed by the other party; (b) no waiver that may be given by a party will be applicable except in
the specific instance for which it is given; and (c) no notice to or demand on one party will be
deemed to be a waiver of any obligation of such party or of the right of the party giving such
notice or demand to take further action without notice or demand as provided in this Agreement, the
Transaction Documents, or the other documents referred to herein.

     12. Entire Agreement and Modification. This Agreement, the Exhibits and Schedules
hereto, the other Transaction Documents, and the other documents referred to herein comprise the
entire agreement and understanding between the parties and supersede any prior written agreement or
understanding and any prior or contemporaneous oral agreement or undertaking relating to the
subject matter of this Agreement. This Agreement may not be amended or modified except by a
written agreement duly executed by each of the parties hereto.

     13. Assignment. This Agreement shall be binding upon and inure to the benefit of and
be enforceable by the successors and permissible assigns of Seller and Buyer, including any
successor trustee appointed in the Bankruptcy Case. This Agreement and any rights hereunder shall
not be assigned, hypothecated, or otherwise transferred by any party hereto without the prior
written consent of the other party hereto, provided that (a) Seller may assign its right to receive
the Purchase Royalty Payments, and any associated rights to audit or review such Purchase Royalty
Payments, without written consent of Buyer, provided, however, that Seller must provide prompt
written notice to Buyer of any such assignment, and (b) Buyer may assign

23

 

its rights hereunder to a subsidiary or affiliate of Buyer at Closing or thereafter, provided
that no assignment by Buyer shall relieve Buyer of its obligations hereunder.

     14. Severability. If any provision of this Agreement is held invalid or unenforceable
by any court of competent jurisdiction, the other provisions of this Agreement will remain in full
force and effect, if all of the essential terms and conditions herein for each party remain in full
force and effect. Any provision of this Agreement held invalid or unenforceable only in part or
degree will remain in full force and effect to the extent not held invalid or unenforceable,
provided that all of the essential terms and conditions herein for each party remain in full force
and effect.

     15. Time of the Essence. With regard to all dates and time periods set forth or
referred to in this Agreement, time is of the essence.

     16. Governing Law; Bankruptcy Court Jurisdiction. This Agreement shall be governed by
and construed in accordance with the law of the Commonwealth of Massachusetts, without giving
effect to any choice or conflict of law provision or rule that would cause the application of the
law of any other jurisdiction. The parties agree that the Bankruptcy Court shall retain exclusive
jurisdiction to enforce the provisions of this Agreement, the Bidding Procedures Order, the Sale
Order, and the Assumption and Assignment Order. With respect to the above jurisdiction, the
parties expressly and irrevocably (a) consent and submit to the personal jurisdiction of such court
in any such action or proceeding, (b) waive any claim or defense in any such action or proceeding
based on any alleged lack of personal jurisdiction, improper venue, or forum non conveniens or any
similar basis, and (c) waive all rights, if any, to trial by jury with respect to any such action
or proceeding.

     17. No Third Party Beneficiaries. Nothing in this Agreement is intended or shall be
construed to give any person or entity, other than the parties hereto, any legal or equitable
right, remedy, or claim under or in respect of this Agreement, the Bidding Procedures Order, and
the Assignment and Assumption Order or any provision contained herein or in any schedule or exhibit
attached hereto.

     18. No Liability of Officers and Directors. The parties hereto acknowledge and agree
that any individual executing this Agreement or any certificates or other documents contemplated by
this Agreement on behalf of Buyer or Seller do so on behalf of such entities and not in their
individual capacities. As such, no officer, director, employee, or agent of Buyer or Seller shall
have any liability hereunder.

     19. Counterparts. This Agreement may be executed in any number of counterparts, each
of which shall be deemed an original for all purposes and all of which together shall constitute
one and the same instrument. The exchange of copies of this Agreement or amendments thereto and of
executed signature pages by facsimile transmission or by email transmission in portable digital
format, or similar format, shall constitute effective execution and delivery of such instrument(s)
as to the parties and may be used in lieu of the original Agreement or amendment for all purposes.
Signatures of the parties transmitted by facsimile or by email in portable digital format, or
similar format, shall be deemed to be their original signatures for all purposes.

24

 

     20. Headings. The headings contained in this Agreement are inserted only as a matter
of convenience and for reference and in no way define, limit, or describe the scope or intent of
this Agreement.

[signature page follows]

25

 

     IN WITNESS WHEREOF, Seller and Buyer have caused this Agreement to be executed by their
respective duly authorized officers as of the day and year first written above.

	 	 	 	 	 
	 	OSCIENT PHARMACEUTICALS CORPORATION

 	 
	 	By:  	/s/ Steven M. Rauscher
 	 
	 	 	Name:  	Steven M. Rauscher 	 
	 	 	Title:  	President & CEO 	 
	 

Signature Page to FACTIVE Asset Purchase Agreement

 

 

	 	 	 	 	 
	 	CORNERSTONE BIOPHARMA, INC.

 	 
	 	By:  	/s/ David Price
 	 
	 	 	Name:  	David Price 	 
	 	 	Title:  	Executive Vice President, Finance and CFO 	 
	 

Signature Page to FACTIVE Asset Purchase Agreement

 

 

EXHIBIT 1.4.3

JOINT ESCROW INSTRUCTIONS

     1. Establishment of Escrow Account. Pursuant to Section 1.4.3 of the attached Asset
Purchase Agreement (the “Purchase Agreement”),1 Buyer shall deliver to Ropes &
Gray LLP, as escrow agent (together with its successors, “Escrow Agent”) cash in the amount
of Five Hundred Thousand Dollars ($500,000), which amount represents a portion of the Purchase
Price as set forth in the Purchase Agreement. Such amount, together with all other amounts from
time to time held by Escrow Agent pursuant to the terms hereof, are herein referred to as the
“Escrow Funds.” Escrow Agent hereby agrees to hold the Escrow Funds in a non-interest
bearing account with Citizens Bank (the “Escrow Account”) as provided in these Joint Escrow
Instructions. The purpose of the Escrow Account is to provide a source from which any amounts
which may become owing to Seller under the Purchase Agreement may be paid.

     2. Disposition of Escrow Funds. Escrow Agent will hold the Escrow Funds in its
possession in the Escrow Account until authorized hereunder to deliver such Escrow Funds as
follows:

     2.1. As provided in a joint written direction of Buyer and Seller;

     2.2. Not earlier than five days after receipt of, and as provided in, a written direction by
Buyer or Seller following termination of the Purchase Agreement pursuant to Section 10 of the
Purchase Agreement, provided, however, if the Bankruptcy Court has approved a sale
of the Purchased Assets to a bidder other than Buyer, then Seller may hold the Escrow Funds until
the earlier of the closing of the sale to such bidder or five days after the Sale Hearing; or

     2.3. As provided in an order of the Bankruptcy Court or other court of competent jurisdiction.

     3. Escrow Agent.

     3.1. Escrow Agent shall have no duties or responsibilities, including, without limitation, any
duty to review or interpret the Purchase Agreement in its capacity as Escrow Agent, except those
expressly set forth herein. Buyer acknowledges that Ropes & Gray LLP is counsel to Seller and
agrees that Ropes & Gray LLP may continue to advise and represent Seller, including in connection
with any dispute related to the Purchase Agreement or the Escrow Funds.

     3.2. If Escrow Agent shall be uncertain as to its duties or rights hereunder or shall receive
instructions from Buyer or Seller with respect to the Escrow Account, which, in its opinion, are in
conflict with any of the provisions of these Joint Escrow Instructions, or if Buyer or Seller, for
any reason, contests instructions delivered by the other with respect to the Escrow Account, Escrow
Agent shall refrain from taking any action until it shall be directed otherwise in

 

			
	1	 	Capitalized terms defined in the Purchase Agreement and
not otherwise defined herein are used herein with the meanings so defined.

 

 

a joint writing by Buyer and Seller or by order of the Bankruptcy Court or other court of
competent jurisdiction. Escrow Agent shall be protected in acting upon any notice, request,
waiver, consent, receipt, or other document reasonably believed by Escrow Agent to be signed by the
proper party or parties. Promptly following receipt of any notices hereunder, with respect to
disposition of Escrow Funds, Escrow Agent shall provide copies of such notices to the other party
with interest in such Escrow Funds, provided that the Escrow Agent shall have no liability for
failure to provide such notice except to the extent provided in Section 3.3 of these Joint Escrow
Instructions.

     3.3. Escrow Agent shall not be liable for any error or judgment or for any act done or step
taken or omitted by it in good faith or for any mistake of fact or law, or for anything that it may
do or refrain from doing in connection herewith, except its own bad faith, gross negligence or
willful misconduct, and Escrow Agent shall have no duties to anyone except Buyer and Seller.
Escrow Agent shall have no liability related to the selection of the financial institution in which
the Escrow Funds are maintained.

     3.4. Escrow Agent may consult independent legal counsel in the event of any dispute or
question as to the construction of these Joint Escrow Instructions, or Escrow Agent’s duties
hereunder, and Escrow Agent shall incur no liability and shall be fully protected with respect to
any action taken or omitted in good faith in accordance with the opinion and instructions of such
counsel.

     3.5. In the event of any disagreement between Buyer and Seller or either of them, and/or any
other person, resulting in adverse claims and demands being made in connection with or for the
Escrow Funds, Escrow Agent shall be entitled at its option to refuse to comply with any such claim
or demand, so long as such disagreement shall continue, and in so doing Escrow Agent shall not be
or become liable for damages or interest to Buyer or Seller or to any person named herein for its
failure or refusal to comply with such conflicting or adverse demands. Escrow Agent shall be
entitled to continue so to refrain and refuse so to act until all differences shall have been
resolved by agreement and Escrow Agent shall have been notified thereof in writing signed by Buyer
and Seller. In the event of such disagreement, Escrow Agent in its discretion may file a suit in
interpleader for the purpose of having the respective rights of the claimants adjudicated, if
Escrow Agent determines such action to be appropriate under the circumstances, and may deposit with
the court in which the suit in interpleader was filed the Escrow Funds and any other property held
hereunder. Each of Buyer and Seller agree to pay one-half of all out-of-pocket costs and expenses
incurred by Escrow Agent in such action, including reasonable attorney’s fees (and Buyer and Seller
agree that if its share of such costs have not previously been paid that such costs shall be paid
from the Escrow Funds prior to the disbursement of such funds, but only if it is entitled to
receive the Escrow Funds).

     3.6. Buyer and Seller hereby jointly and severally indemnify, defend, and hold Escrow Agent
harmless from all losses, costs, and expenses that may be incurred by it as a result of its
involvement in any arbitration or litigation arising from the performance of its duties hereunder,
provided that such losses, costs, and expenses shall not have resulted from the bad faith, willful
misconduct, or gross negligence of Escrow Agent. Solely as between Buyer and Seller, such
indemnification shall be borne in equal proportions by Buyer and Seller. Such indemnification

 

 

shall survive termination of the escrow arrangement established hereunder until extinguished
by any applicable statute of limitations.

     3.7. Escrow Agent does not own or have any interest in the Escrow Account or the Escrow Funds
but is serving as escrow holder only, having only possession thereof and agreeing to hold and
distribute the Escrow Funds in accordance with the terms and conditions of these Joint Escrow
Instructions. This paragraph shall survive notwithstanding any termination of these Joint Escrow
Instructions or the resignation of Escrow Agent.

     3.8. Escrow Agent may at any time resign as such by delivering the Escrow Funds to (i) any
banking corporation or trust company organized under the laws of the United States or of any state
which corporation or company is jointly designated by the other parties hereto in writing as
successor escrow agent and consents in writing to act as successor escrow agent or (ii) the
Bankruptcy Court or any other court of competent jurisdiction; whereupon Escrow Agent shall be
discharged of and from any and all further obligations arising in connection with these Joint
Escrow Instructions. The resignation of the Escrow Agent will take effect on the earlier of (x)
the appointment of a successor escrow agent by Buyer and Seller and delivery of the Escrow Funds to
such successor escrow agent (or delivery of the Escrow Funds to the Bankruptcy Court or any other
court of competent jurisdiction) or (y) the day that is 60 days after the date of delivery of its
written notice of resignation to Buyer and Seller. If at that time the Escrow Agent has not
received a designation of a successor escrow agent, the Escrow Agent’s sole responsibility after
that time shall be to safekeep the Escrow Funds until receipt of a designation of successor escrow
agent, a joint written instruction as to disposition of the Escrow Funds by Buyer and Seller, or a
final order of the Bankruptcy Court or any other court of competent jurisdiction mandating
disposition of the Escrow Funds.

 

 

Acknowledged and Agreed:

Ropes & Gray LLP, Escrow Agent

	 	 	 	 	 
	By:

	 	/s/ James M. Wilton
	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	Name:

	 	James M. Wilton	 	 
	 
	 	 	 	 
	Title:

	 	Partner	 	 

 

 

Oscient Pharmaceuticals Corp., Seller

	 	 	 	 	 
	By:

	 	/s/ Steven M. Rauscher
	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	Name:

	 	Steven M. Rauscher	 	 
	 
	 	 	 	 
	Title:

	 	President & CEO	 	 

 

 

Cornerstone BioPharma, Inc., Buyer

	 	 	 	 	 
	By:

	 	/s/ David Price
	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	Name:

	 	David Price	 	 
	 
	 	 	 	 
	Title:

	 	Executive Vice President, Finance and CFO	 	 

 

 

EXHIBIT 5.3(A)

BILL OF SALE

 

 

BILL OF SALE

     BILL OF SALE, made, executed and delivered on August ___, 2009, by OSCIENT PHARMACEUTICALS
CORPORATION, a Massachusetts corporation (the “Seller”) to CORNERSTONE BIOPHARMA, INC., a
Nevada corporation (“Buyer”).

W I T N E S S E T H:

     WHEREAS, the Seller and the Buyer are parties to that certain Asset Purchase Agreement dated
July 13, 2009 by and between Buyer and Seller, which Asset Purchase Agreement was approved and
supplemented or modified by a Sale Order (i) Approving and Authorizing Sale of Certain of Debtor’s
Assets Free and Clear of any and all Liens, Claims, Encumbrances and Other Interests; (ii)
Approving the Assumption and Assignment of Certain Executory Contracts; and (iii) Granting Related
Relief issued by the United States Bankruptcy Court, District of Massachusetts (Eastern Division)
(the “Court”) on ___ ___, 2009 (the “Sale Order,” and as so approved and
supplemented or modified by the Sale Order and hearings of the Court, the “Agreement”),
providing for, among other things, the transfer and sale to the Buyer of certain of the assets of
the Seller all as more fully described in the Agreement for consideration of the Purchase Price
(such capitalized term and, except as defined herein, all other capitalized terms used herein shall
have the same meanings ascribed to them in the Agreement), and on the terms and conditions provided
in the Agreement; and

     WHEREAS, the Buyer and the Seller now desire to carry out the intent and purpose of the
Agreement by the Seller’s execution and delivery to the Buyer of this instrument evidencing the
sale, conveyance, assignment, transfer and delivery to the Buyer of the Purchased Assets, subject
to the Assumed Liabilities and subject to the terms and conditions of the Agreement and excluding
the Excluded Liabilities and any and all other liabilities not explicitly assumed pursuant to the
Agreement; and

     NOW, THEREFORE, in consideration of the foregoing premises and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the Seller does
hereby, effective from and after the date hereof, sell, convey, assign, transfer and deliver unto
the Buyer and its successors and assigns, forever, the entire right, title and interest in, to and
under the Purchased Assets, subject only to the Assumed Liabilities and subject to the terms and
conditions of the Agreement and free and clear of the Excluded Liabilities and all other all liens,
claims, restrictions, easements, rights of way, security agreements, rights of third parties,
options or encumbrances.

     TO HAVE AND TO HOLD the Purchased Assets unto the Buyer, its successors and assigns, FOREVER.

 

 

     The Seller hereby constitutes and appoints the Buyer and its successors and assigns as its
true and lawful attorneys in fact in connection with the transactions contemplated by this
instrument, with full power of substitution, in the name and stead of the Seller but on behalf of
and for the benefit of the Buyer and its successors and assigns, to demand and receive any and all
of the assets, properties, rights and business hereby conveyed, assigned, and transferred or
intended so to be, and to give receipt and releases for and in respect of the same and any part
thereof, and from time to time to institute and prosecute, in the name of the Seller or otherwise,
for the benefit of the Buyer or its successors and assigns, proceedings at law, in equity, or
otherwise, which the Buyer or its successors or assigns reasonably deem proper in order to collect
or reduce to possession or endorse any of the assets, properties, rights and business, and to do
all acts and things in relation to the assets which the Buyer or its successors or assigns
reasonably deem desirable.

     This Bill of Sale shall be construed and enforced in accordance with applicable federal law
and the laws (other than the conflict of law rules) of the Commonwealth of Massachusetts.

     In the event that any provision of this Bill of Sale is construed to conflict with a provision
of the Agreement, the provision of the Agreement shall be deemed to be controlling.

     This instrument shall be binding upon and shall inure to the benefit of the respective
successors and assigns of the Seller and the Buyer.

     If and to the extent requested to do so by Buyer, Seller and its agents shall fully cooperate
with Buyer, and do any and all acts and execute and deliver any and all documents which may be
necessary, to effectuate the transfer of assets contemplated herein.

[The rest of this page intentionally left blank]

 

 

     IN WITNESS WHEREOF, this Bill of Sale has been duly executed and delivered by a duly
authorized representative of the Seller on the date first above written.

	 	 	 	 	 
	 	OSCIENT PHARMACEUTICALS CORPORATION

 	 
	 	By:  	 	 
	 	Name:  	 	 
	 	Title:  	 	 
	 

 

 

EXHIBIT 5.3(B)

ASSUMPTION AND ASSIGNMENT AGREEMENT

 

 

ASSIGNMENT AND ASSUMPTION AGREEMENT

     ASSIGNMENT AND ASSUMPTION AGREEMENT, entered into on August ___, 2009 by Oscient
Pharmaceuticals Corporation, a Massachusetts corporation (the “Seller”) and Cornerstone
BioPharma, Inc., a Nevada corporation (the “Buyer”).

WITNESSETH

     WHEREAS, the Buyer and the Seller are parties to that certain Asset Purchase Agreement dated
July 13, 2009 by and between Buyer and Seller, which Asset Purchase Agreement was approved and
supplemented or modified by a Sale Order (i) Approving and Authorizing Sale of Certain of Debtor’s
Assets Free and Clear of any and all Liens, Claims, Encumbrances and Other Interests; (ii)
Approving the Assumption and Assignment of Certain Executory Contracts; and (iii) Granting Related
Relief issued by the United States Bankruptcy Court, District of Massachusetts (Eastern Division)
(the “Court”) on ___ ___, 2009 (the “Sale Order,” and as so approved and
supplemented or modified by the Sale Order and hearings of the Court, the “Agreement”).
Pursuant to the Agreement, the Seller agreed to sell, and the Buyer agreed to purchase, certain
assets described therein as the Purchased Assets (such capitalized term and, except as defined
herein, all other capitalized terms used herein shall have the same meanings ascribed to them in
the Agreement).

     WHEREAS, pursuant to the Agreement, the Seller agreed to assign and the Buyer agreed to assume
certain contracts of the Seller, including the Assigned Contract and the other Closing Date
Assigned Contracts (as defined in the Sale Order) described in Exhibit A attached hereto.

     NOW, THEREFORE, in consideration of the foregoing premises and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the Buyer and the
Seller hereby agree as follows:

     1. Effective from and after the Closing, the Seller hereby assigns to the Buyer, free and
clear of all liens and encumbrances, the Assigned Contract and the other Closing Date Assigned
Contracts.

     2. Effective from and after the Closing, the Buyer hereby assumes the Assigned Contract and
the other Closing Date Assigned Contracts.

     3. This Assignment and Assumption Agreement shall be construed and enforced in accordance with
applicable federal law and the laws (other than the conflict of law rules) of the Commonwealth of
Massachusetts.

     4. In the event that any provision of this Assignment and Assumption Agreement is construed to
conflict with a provision of the Agreement, the provision in the Agreement shall be deemed
controlling.

     5. This Assignment and Assumption Agreement shall bind and shall inure to the benefit of the
respective parties and their assigns, transferees and successors.

 

 

     6. If and to the extent reasonably requested to do so by Buyer, Seller and its agents shall
fully cooperate with Buyer, and do any and all acts and execute and deliver any and all
documents which may be necessary or convenient, to effectuate the transfer of assets
contemplated herein.

 

 

     IN WITNESS WHEREOF, the undersigned have executed this Assignment and Assumption Agreement as
of the date first above written.

	 	 	 	 	 
	 	OSCIENT PHARMACEUTICALS CORPORATION

 	 
	 	By:  	 	 
	 	Name:  	 	 
	 	Title:  	 	 
	 
	 	CORNERSTONE BIOPHARMA, INC.

 	 
	 	By:  	 	 
	 	Name:  	 	 
	 	Title:  	 	 
	 

 

 

EXHIBIT A

	 	 	 	 	 
	Name	 	Parties	 	Date
	License and Option
Agreement

	 	Oscient
Pharmaceuticals Corp.
(as successor in
interest to Genesoft
Pharmaceuticals,
Inc.) and LG Life
Sciences, Ltd.
	 	October 22, 2002 (as amended)

 

 

SCHEDULE 1.1.1

Registered Trademarks

Seller owns no registered trademarks. Trademarks are licensed to Seller pursuant to the LG Life
Sciences, Ltd. License.

 

 

SCHEDULE 1.1.6

Assigned Contract

	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Estimated Cure
	Counterparty	 	Notice Address	 	Date	 	Type	 	Amount
	LG Life Sciences, Ltd.

	 	LG Twin Tower

20 yoido-dong, Youngdugpo-gu
Seoul, 150-721, Republic of
Korea
	 	10/22/2002, as
amended on
11/21/2002,
12/6/2002,
10/16/2003,
3/31/2005,
2/3/2006, 2/3/2006,
and 12/27/2006
	 	License
	 	$	100,000.00	 

Additional Assigned Contracts

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Estimated Cure Amount
	 	 	 	 	 	 	 	 	 	 	 	 	Q2 Rebate	 	Q3 Rebate	 	 	 	 
	Counterparty	 	Notice Address	 	Date	 	Type	 	Billed	 	Estimated	 	Estimated	 	Other	 	Total
	Abt Bio-Pharma Solutions, Inc.

	 	181 Spring Street
Lexington, MA 02421
	 	10/08/2008
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	Allscripts, LLC

	 	2401 Commerce Drive
Libertyville, IL 60048
	 	12/15/2006
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	Expeditors International of Washington, Inc.

	 	1015 Third Avenue, 12th Floor
Seattle, WA 98102
Attn: Legal Department
	 	10/30/2006
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	G & S Research, Inc.

	 	9229 Delegates Row, Suite 400
Indianapolis, IN 46240
	 	8/1/2008
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	Integrated Commercialization Solutions, Inc.

	 	Integrated Commercialization Solutions, Inc.
4006 Beltline Road, Suite 100
Addison, Texas 75001
Attn: Vice President & General Manager

   with a copy to:
AmerisourceBergen Corporation
1300 Morris Drive, Suite 100
Chesterbrook, PA 19087
Attn: General Counsel
	 	6/24/2004, as amended on 8/21/2006, 5/1/2007, and 2/1/2008
	 	Contract
	 	$	20,390.55	 	 	 	n/a	 	 	 	n/a	 	 	$	28,283.67	 	 	$	48,674.22	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Estimated Cure Amount
	 	 	 	 	 	 	 	 	 	 	 	 	Q2 Rebate	 	Q3 Rebate	 	 	 	 
	Counterparty	 	Notice Address	 	Date	 	Type	 	Billed	 	Estimated	 	Estimated	 	Other	 	Total
	International Health Management Associates, Inc.

	 	2122 Palmer Drive
Schaumburg, IL 61073
	 	12/1/2008
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	Menarini International Operation Luxembourg SA

	 	Menarini International Operation Luxembourg SA
1, Avenue de La Gar, L-1611
Luxembourg GD
Attn: Menaring Director

   with a copy to:
A. Menarini Industrie Farmaceutiche Riunite SRL
3, Via Sette Santi
50131 Florence — Italy
Attn: Legal Affairs
	 	12/28/2006, as amended
	 	Sublicense
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	National Patient Services, Inc.

	 	14362 N. Frank Lloyd Wright Blvd
Scottsdale, AZ 85269
Attn: Rick Randall
	 	1/27/2003
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	PAREXEL International, LLC

	 	200 West Street
Waltham, MA 02451
Attn: General Counsel
	 	1/27/2003
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	262.00	 
	Patheon Pharmaceuticals Inc.

	 	Patheon Pharmaceuticals Inc.
2100 East Galbraith Raod
Cincinnati, OH 45215
Attn: Director of Legal Services

   with a copy to:
Patheon Inc.
7070 Mississauga Road, Suit 350
Mississauga, Ontario L5N 7J8
Attn: President, North America
	 	1/20/2005
	 	Contract
	 	$	89,122.25	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	89,122.25	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Estimated Cure Amount
	 	 	 	 	 	 	 	 	 	 	 	 	Q2 Rebate	 	Q3 Rebate	 	 	 	 
	Counterparty	 	Notice Address	 	Date	 	Type	 	Billed	 	Estimated	 	Estimated	 	Other	 	Total
	Pfizer, S.A. de C.V.

	 	Pfizer, S.A. de C.V.
Paseo de los Tamarindos #40
Bosques de las Lomas
Mexico Distrito Federal, 05120
Attn: Business Planning Director

   with a copy to:
Pfizer, S.A. de C.V.
Paseo de los Tamarindos #40
Bosques de las Lomas
Mexico Distrito Federal,
05120
Attn: Legal Director
	 	2/6/2006
	 	Sublicense
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	PharmaSight Research, LLC

	 	1 Villa Drive, Suite 200
Ambler, PA 19002
	 	7/29/2008
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 
	State of Connecticut Department of Social Services

	 	Connecticut Department of Social Services
25 Sigourney Street
Hartford, CT 06106-5033
Attn: Evelyn Dudley
	 	10/1/2008
	 	Contract
	 	$	288.63	 	 	$	152.97	 	 	$	20.40	 	 	$	0.00	 	 	$	462.00	 
	State of South Carolina Department of Health and Human Services

	 	S.C. Department of Health and Human Services
Attn: Pharmacy Services
P.O. Box 8206
Columbia, SC 29202-8206
	 	4/1/2006
	 	Contract
	 	$	13.60	 	 	$	7.21	 	 	$	0.96	 	 	$	0.00	 	 	$	21.77	 
	Triple i, Division of MediMedia, UDA, Inc.

	 	350 Starke Road
Carlstadt, NJ 07072
	 	11/20/2006
	 	Contract
	 	 	 	 	 	 	n/a	 	 	 	n/a	 	 	 	 	 	 	$	0.00	 

 

 

SCHEDULE 1.1.8

NDA 

Factive — NDA (Oral) 21-158 submitted December 15, 1999, resubmitted October 4, 2002, approved
April 4, 2003

NDA Supplements

	 	 	 	 	 	 	 
	Supplement	 	 	 	Submission	 	 
	Number	 	Title	 	Date	 	Approval Date
	001

	 	Multi-Drug Resistant Streptococcus
pneumoniae (MDRSP) Claim — Efficacy
Supplement — PAS
	 	03 June 2003
	 	25 July 2003
	 
	 	 	 	 	 	 
	002

	 	Drug Resistance Labeling Change CBE
	 	05 Feb 2004
	 	28 July 2004
	 
	 	 	 	 	 	 
	003

	 	Quinolone Class Label Change — CBE
	 	26 Mar 2004
	 	07 Sep 2004
	 
	 	 	 	 	 	 
	004

	 	Add Patheon Pharmaceuticals as
additional manufacturer — CBE 30
	 	14 Apr 2005
	 	14 Oct 2005
	 
	 	 	 	 	 	 
	005

	 	Label change to revise safety
language regarding concomitant use
of warfarin or its derivatives — CBE
	 	12 Aug 2005,
	 	26 Oct 2006
	 
	 	 	 	 	 	 
	006 (ABS) and 007
(CAP)

	 	Efficacy Supplement for 5-day
treatment data for both CAP and ABS
Indication
	 	18 Nov 2005,
	 	S007 approved 01
May 2007
S006 was not
approved for 5-day
ABS
	 
	 	 	 	 	 	 
	008

	 	Change in synthetic route for
SB-326208 (QN09) CMC Supplement —
CBE 30
	 	22 Dec 2005
	 	23 June 2006
	 
	 	 	 	 	 	 
	009

	 	Add Procos SpA as an additional
manufacturer for SB-326207 (AM19)
starting material — CBE 30
	 	14 Sept 2006
	 	13 Mar 2009
	 
	 	 	 	 	 	 
	010

	 	Add Cardinal Health as additional
packager — CBE 30
	 	18 Jan 2007
	 	19 July 2007
	 
	 	 	 	 	 	 
	011

	 	Label Change regarding phototoxicity
	 	25 June 2007
	 	19 Dec 2008
	 
	 	 	 	 	 	 
	012

	 	Addition of Boxed Warning and
Medication Guide and changes to the
PI for Tendonitis and Tendon Rupture
CBE
	 	04 Aug 2008
	 	03 Oct 2008
	 
	 	 	 	 	 	 
	013

	 	Factive Carton Final Printed Labeling
	 	11 Nov 2008
	 	29 Oct 2008
	 
	 	 	 	 	 	 
	014

	 	Proposed Risk Evaluation and
Mitigation Strategy (REMS)
	 	03 Nov 2008
	 	27 Mar 2009
	 
	 	 	 	 	 	 
	015

	 	Removal of Heavy Metal Specification
for Opadry — CBE 30
	 	08 Dec 2008
	 	05 June 2009
	 
	 	 	 	 	 	 
	016

	 	Restoration of in-process LOD
specification — PAS
	 	23 Mar 2009
	 	Pending, user fee
date 24 July 2009

 

 

INDs

Factive — IND (IV) 60-132 submitted April 6, 2000

Factive — IND (Oral) 53-908 submitted August 6, 1997

Foreign Regulatory Filings

	 	 	 	 	 	 	 	 	 
	Country/	 	 	 	 	 	Trade	 	 
	Region	 	Action Date a	 	Launch Date	 	Name(s)	 	Comments
	Canada

	 	A — 09 March 2004
	 	02 February 2006
	 	Factive
	 	•      Held by Oscient Pharmaceuticals

	 

	 	 	 	 	 	 	 	•      Indicated for AECBb

	 

	 	 	 	 	 	 	 	•      sNDA submitted on
10 November 2006 for 5-day CAP; withdrawn
without prejudice on 10 May 2007

	 

	 	 	 	 	 	 	 	•      sNDA submitted 05 March 2007 for ABS;
withdrawn without prejudice on 19 April 2007

	 

	 	 	 	 	 	 	 	•      19 February 2009: deactivation of DIN
as no current marketing of Factive in Canada

	 
	 	 	 	 	 	 	 	 
	Mexico

	 	A — 28 July 2006
	 	17 August 2006
	 	Factive
	 	•      Held by Pfizer, S.A. de C.V.

	 

	 	 	 	 	 	 	 	•      Indicated for CAP, AECB, ABS

	 

	 	 	 	 	 	 	 	•      Approved for UTI in
09 December 2008

	 
	 	 	 	 	 	 	 	 
	United Kingdom

	 	V — 16 January 2007
	 	N/A
	 	N/A
	 	•      Application submitted
30 June 2000

	 

	 	 	 	 	 	 	 	•      Non-approvable decision issued
November 2002; appealed

	 

	 	 	 	 	 	 	 	•      Application withdrawn on 16 January
2007

 

			
	a	 	Abbreviations for action: A=authorized; V=voluntary marketing application withdrawal by company.
	 
	b	 	Abbreviations for indications: CAP=community acquired pneumonia; AECB=acute bacterial exacerbation of chronic bronchitis;
ABS=acute bacterial sinusitis; UTI=uncomplicated urinary tract infection

 

 

SCHEDULE 3.8

Legal Proceedings; Orders

     On May 30, 2008, Seller received notice of a Paragraph IV certification from Orchid
Healthcare, a Division of Orchid Chemicals & Pharmaceuticals Ltd. (“Orchid”), notifying
Seller of the filing of an abbreviated new drug application (“ANDA”) with the FDA for a
generic version of FACTIVE. Orchid’s notice sets forth allegations that eight of the nine FDA
Orange Book listed patents are invalid and/or will not be infringed by Orchid’s manufacture,
importation, use, or sale of the product for which the ANDA was submitted.

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