Exhibit 10.1

 

ANDA SALE AND ASSIGNMENT AGREEMENT FOR ANDA’s listed on Exhibit “A” dated as of
August 12, 2005 (this “Agreement”), by and between AMERICAN ANTIBIOTICS, LLC., a
Florida Limited Liability Company formed by GEOPHARMA, INC. having its principal
place of business at 6950 Bryan Dairy Road, Largo, Florida 33777 (“Buyer”), and
CONSOLIDATED PHARMACEUTICAL GROUP, INC., a corporation organized under the laws
of Maryland having its principal place of business at 6110 Robinwood Road,
Baltimore, Maryland 21225 (“Seller”).

 

BACKGROUND

 

Seller desires to sell, transfer and assign to Buyer, and Buyer desires to
purchase and acquire from Seller, all of Seller’s right, title and interest to
its ANDAs and certain equipment, as is as outlined in Exhibit A and Exhibit B,
all on the terms and subject to the conditions set forth herein.

 

In consideration of the mutual promises, covenants, representations, warranties
and agreements, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties, intending to be
legally bound, hereby covenant and agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

The terms defined in this Article I, whenever used herein shall have the
following meanings:

 

1.1 “Affiliate” shall mean any Person that directly or indirectly controls, is
controlled by or is under common control with another Person. A person or entity
shall be deemed to control a corporation (or other entity) if such person or
entity possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of such corporation (or other entity)
whether through the ownership of voting securities, by contract or otherwise.

 

1.2 “Agreement” shall mean this agreement between Seller and Buyer.

 

1.3 “ANDA” shall mean an abbreviated new drug application filed with the FDA
covering a Product.

 

1.4 “Buyer” shall have the meaning set forth in the first paragraph of this
Agreement.

 

1.5 “Buyer Claimant” shall have the meaning set forth in the Section 7.1 of this
Agreement.

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1.6 “Encumbrance” shall mean any lien, encumbrance, option, right of first
refusal or security interest of any kind whatsoever.

 

1.7 “Excluded Liabilities” shall have the meaning set forth in Section 2.1(b) of
this Agreement.

 

1.8 “FDA” shall mean the United States Food and Drug Administration.

 

1.9 “Included Assets” shall mean all of Seller’s right, title and interest in,
to and under all Included Books and Records, Included Intellectual Property,
Included Authorizations, including without limitation those assets identified on
Exhibit A and Exhibit B hereto.

 

1.10 “Included Authorizations” shall mean Seller’s ANDA per Exhibit A all
supplements and amendments thereto, including all pending or in-process
registrations, supplements and amendments related to the Products, including
without limitation those documents identified on Exhibit A.

 

1.11 “Included Books and Records” shall mean copies, if any, only to the extent
specifically related to the Products, of all annual reports and adverse event
reports related to the ANDAs, correspondence with the FDA, exception reports and
investigations, specification for raw materials and FDA communication thereon,
communication relating to packaging with any of the FDA, vendors or suppliers,
master batch records and batch records for released batches, samples (except
that Seller shall be entitled to hold such representative portions of the
samples as is required by law), stability and special study data, analytical
methods and validation, process validation and complaints files, new or improved
manufacturing process documentation, validations documents, lab notebooks and
technical data files (upon request for such notebooks and files by Buyer) and
field alert reports, related to the Products, including without limitation those
books and records identified on Schedule 1.13 hereto.

 

1.12 “Included Intellectual Property” shall mean all know-how, information,
including without limitation any scientific, pharmaceutical or technical
information, substances, techniques, processes, systems, designs, expertise,
screens, models, methods, assays, screenings, patents, inventions (whether
patented, patentable or not), discoveries, trade secrets, together with all
experience, data, formulas, procedures and results, and including all
biological, chemical, pharmacological, toxicological, clinical, analytical,
assay, quality control, and manufacturing data and technology and any
improvements, modifications and/or alternations made thereto, relating to the
Products, including without limitation those identified on Exhibit A hereto.

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1.13 “Indemnitee” and “Indemnitor” shall have the meanings set forth in
Section 7.3(a) of this Agreement.

 

1.14 “Leases” shall have the meaning set forth in Section 7.1 of this Agreement.

 

1.15 “Person” shall mean any natural person, corporation, limited or limited
liability partnership, general partnership, joint venture, association,
joint-stock company, limited liability company, company, trust, bank, trust
company, land trust, business trust or other organization whether or not a legal
entity, and any governmental unit or agency or political subdivision thereof.

 

1.16 “Equipment” means all equipment all ready installed in the facilities, as
is.

 

1.17 “Transfer Date” shall mean, with respect to each ANDA related to a Product,
the date that the FDA accepts and records the transfer of the ANDA related to
such Product by Seller to Buyer.

 

ARTICLE II

 

SALE AND PURCHASE OF THE INCLUDED ASSETS

 

2.1 Purchase of the Included Assets.

 

(a) Upon the terms and subjects to the conditions hereof, and upon the basis of
the agreements, representations and warranties contained in this Agreement,
effective as of the date hereof, Seller hereby sells, transfers, assigns,
conveys and delivers to Buyer, and Buyer hereby purchases and acquires from
Seller, all of the Included Assets, free and clear of Encumbrances.

 

2.2 Purchase Price. In consideration for the sale and assignments of the
Included Assets outlined in Exhibit A and Exhibit B; Buyer shall pay to Seller a
purchase price of $3,000,000 payable (I) $500,000 in cashier’s check at the
signing of this agreement and (II) $2,500,000 in a note, payable to the Seller
(Seller’s Note) payable to the Buyer under the following terms:

(1) Terms: 3 years

 

(2) Three equal installments, with first installment due 12 months from the date
of signing this letter.

 

(3) Interest 5% payable annually with the principle.

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2.3 Notifications and Consents. Simultaneously herewith, the Seller is
delivering to Seller executed assignments of the ANDAs together with written
notification to the FDA of the immediate transfer of rights to the ANDAs to
Buyer. Buyer and Seller shall use all reasonable efforts to obtain all consents,
approvals and waivers from, and give all notices to, and make all declarations,
filings and registrations with, any governmental and regulatory agencies that
are required to consummate the transactions contemplated hereby. Buyer and
Seller shall coordinate and cooperate with one another and supply such
commercially reasonable assistance as may be reasonably requested by each in
connection with the foregoing. Until the Transfer Date, Seller shall maintain
(at Seller’s sole cost and expense) all existing governmental authorizations,
including ANDAs with respect to the Products. Seller further, agrees that from
the date hereof until such time as the ANDAs are transferred to Buyer, Seller
shall make no amendments or supplements to the ANDAs without the prior written
consent of Buyer, not to be unreasonably withheld, and keep Buyer fully apprised
of all matters relating to the maintenance of the ANDAs.

 

2.4 Adverse Events. Seller and Buyer each agree to notify the other within five
(5) days of any serious and unexpected adverse reactions reported to either of
them resulting from the use of the Products (whether inside or outside of the
Territory). Seller and Buyer shall each notify the other promptly of any other
complains or adverse reactions from third parties reported to either of them
resulting from use of the Products sold under the Seller’s label. Buyer assumes
the responsibility to notify FDA of any and all ADER after the term is
completed.

 

2.5 Further Assistance. Seller shall provide, at Seller’s cost and expense,
commercially reasonable assistance, including without limitation, technology
transfer assistance, requested by Buyer in connection with the coamoxyclav
formulation and technology to Buyer.

 

ARTICLE III

 

REPRESENTATIONS AND WARRANTIES OF SELLER

 

Seller hereby represents and warrants to Buyer as follows:

 

3.1 Organization. Seller is a corporation duly organized, under the laws of the
jurisdiction in which it was formed, with full corporate power and authority to
own, lease and operate its properties and assets and to conduct its business as
it is now being conducted.

 

3.2 Authority. Seller has all requisite power and authority to execute and
deliver this Agreement and to perform, carry out and consummate the transactions
contemplated hereby. The execution, delivery and performance of this Agreement
have been duly authorized by all necessary corporate action on the part of
Seller. This Agreement constitutes

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the legal, valid and binding obligation of Seller, enforceable against Seller in
accordance with its terms.

 

3.3 No Breach. Neither the execution and delivery of this Agreement by Seller
nor the consummation of the transactions contemplated hereby will: (a) result in
the creation of, or give any party the right to create, any Encumbrance upon the
Included Assets; (b) to its knowledge, conflict with, violate, result in breach
of or constitute a default under any judgment, decree, order or process of any
court or governmental authority applicable to Seller.

 

3.4 Assets.

 

(a) Seller has good and freely transferable title to Included Asset per Exhibit
A & Exhibit B, free and clear of all Encumbrances, and, has the complete and
unrestricted power and right to sell and transfer the Included Assets to Buyer
in accordance with the terms hereof.

 

(b) The Included Assets represent all of Seller’s contracts, licenses, permits,
approvals, authorizations, registrations, rights to registrations, pending or
in-process registrations and qualifications (including the ANDAs and supplements
and amendments thereto), issued by any federal, state, local or governmental
authority, United States and foreign patents and pending patent applications,
unpatented inventions, trademarks, service marks, trade names, know-how,
formulae and manufacturing technology, and Included Books and Records, of or for
the Products, other than the Excluded Assets.

 

(c) Seller has not transferred, sold, assigned, licensed or given any rights,
title or interest to the Included Assets to any third party in the territory.

 

3.5 Litigation. There is presently no litigation pending or to its best
knowledge threatened against Seller, relating to any of the Products or the
Included Assets.

 

3.6 No Breach. Neither the execution and delivery of this Agreement by Seller
nor the consummation of the transactions contemplated herein will: (i) violate
any provision of the organizational documents of Seller; (ii) conflict with,
result in a breach of or constitute a default (or an event which, with or
without notice, lapse of time or both, would constitute a default) under, or
give any third party the right to terminate or modify, any material agreement or
other instrument to which Seller is a party or by Seller or any of its assets
are subject or bound; (iii) conflict with, violate, result in a breach of or
constitute a default under any judgment, decree, order or process of any court
or governmental authority applicable to Seller; (iv) conflict with or violate
any material statute, law or regulation applicable to Seller’s business; and
(v) no event has occurred or with the passage of time or the giving of notice
will occur which would prevent Seller from obtaining any authorization, consent,
approval or waives from any federal or state governmental or regulatory
authority required in connection with the manufacture, distribution, export or
sale of the Products in or to the Territory.

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3.7 Regulatory Matters.

 

(a) No individual involved in the preparation or submission of any ANDA or,
supplement or amendment for either product, or in the generation of data
utilized in any such submission, has been debarred, or is subject to debarment,
by any U.S. federal agency.

 

ARTICLE IV

 

REPRESENTATION AND WARRANTIES OF BUYER

 

Buyer hereby represents and warrants to Seller as follows:

 

4.1 Organization and Qualification. Buyer is a corporation duly organized, under
the laws of the jurisdiction in which it was formed, with full corporate power
and authority to own, lease and operate its properties and assets and to conduct
its business as it is now being conducted.

 

4.2 Authority. Buyer has all requisite power and authority to execute and
deliver this Agreement and to perform, carry out and consummate the transactions
contemplated hereby. The execution, delivery and performance of this Agreement
have been duly authorized by all necessary corporate action on the part of
Buyer. This Agreement constitutes the legal, valid and binding obligation of
Buyer, enforceable it in accordance with its terms.

 

4.3 No Breach. Neither the execution and delivery of this Agreement by Buyer nor
the consummation of the transactions contemplated herein will: (i) violate any
provision of the Certificate of Incorporation or By-laws of Buyer, (ii) conflict
with, result in a breach of or constitute a default (or an event which, with or
without notice, lapse of time or both, would constitute a default) under, or
give any third party the right to terminate or modify, any material agreement or
other instrument to which Buyer is a party or by Buyer or any of its assets are
subject or bound; (iii) conflict with, violate, result in a breach of or
constitute a default under any judgment, decree, order or process of any court
or governmental authority applicable to Buyer; (iv) conflict with or violate any
material statute, law or regulation applicable to Buyer’s business; and (v) no
event has occurred or with the passage of time or the giving of notice will
occur which would prevent Buyer from obtaining any authorization, consent,
approval or waiver from any federal or state governmental or regulatory
authority required in connection with the manufacture or sale of the Products in
the Territory.

 

4.4 Buyer takes full responsibility for post-marketing reporting of adverse drug
experiences in accordance with 21 CFR 314.80.

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ARTICLE IV

 

INDEMNIFICATION

 

7.1 Indemnification by Seller. Seller shall indemnify and hold Buyer and its
Affiliates, and their respective directors, officers, employees, agents and
representatives and all of their successors and assigns (collectively “Buyer
Claimants” and individually a “Buyer Claimant”) harmless from and defend each of
them from and against any and all demands, claims, actions, liabilities, losses,
costs damages or expenses whatsoever (including any reasonable attorneys’ fees)
(collectively, “Losses”) asserted against, imposed upon or incurred by the Buyer
Claimants resulting from or arising out of (a) any breach of any representation
or warranty of Seller contained herein; (b) any breach of any covenant or
obligation of Seller contained herein; (c) any claim, indebtedness, liability or
obligation to third parties resulting from or arising out of Seller’s ownership
of the Included Assets prior to the Transfer Date; and (d) any claim related to
the Excluded Liabilities.

 

7.2 Indemnification by Buyer. Buyer shall indemnify and save Seller and its
Affiliates, and their respective directors, officers, employees, agents and
representatives (collectively “Seller Claimants” and individually a “Seller
Claimant”) harmless from and defend each of them from and against any and all
Losses asserted against, imposed upon or incurred by the Seller Claimants
resulting from or arising out of (a) any breach of any representation or
warranty of Buyer contained herein; (b) any breach of any covenant or obligation
of Buyer contained herein; (c) any claim, indebtedness, liability or obligation
to third parties resulting from or arising out of Buyer’s ownership of the
Included Assets.

 

7.3 Limitations.

 

(a) IN NO EVENT SHALL EITHER PARTY HERETO BE RESPONSIBLE OR LIABLE FOR
CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT DAMAGES OF ANY KIND (WHETHER ARISING
UNDER CONTRACT, TORT, OR OTHERWISE) INCLUDING, BUT NOT LIMITED TO, LOST PROFITS
OR LOSS OF BUSINESS OPPORTUNITY, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. IN NO EVENT SHALL ANY PARTY HERETO BE LIABLE FOR ANY PUNITIVE OR
EXEMPLARY DAMAGES.

 

The indemnification rights of the parties under this Agreement are the sole and
exclusive rights and remedies of the parties hereunder for money damages.

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ARTICLE VIII

 

MISCELLANEOUS

 

8.1 Expenses. Each party hereto shall pay its own expenses incurred in
connection with this Agreement. All transfer taxes applicable to the conveyance
and transfer from Seller to Buyer of the Included Assets and any other transfer
or documentary taxes or any filing or recording fees applicable to such
conveyance shall be paid by the party upon whom primary burden for payment is
placed by applicable law. Each party shall use reasonable efforts to avail
itself of any available exemptions from any such taxes or fees, and to cooperate
with the other party in providing any information and documentation that may be
necessary to obtain such exemptions.

 

8.2 Amendment. This Agreement may not be terminated, amended, altered or
supplemented except by a written agreement executed by the parties hereto.

 

8.3 Entire Agreement. This Agreement, including the schedules and exhibits
hereto, the instruments and other documents delivered pursuant to this Agreement
contains the entire agreement of the parties relating to the subject matter of
this Agreement and supersede all prior agreements and understandings of any kind
between the parties respecting such subject matter.

 

8.4 Further Assurances. Buyer and Seller shall, and shall, if applicable, cause
their respective Affiliates to, at the request of the other, execute and deliver
such other instruments of conveyance and transfer and assumption and take such
other action as may be reasonably requested so as to consummate the transactions
contemplated hereby of otherwise to consummate the intent of this Agreement.

 

8.5 Notices. All notices, consents, directions, approvals, instructions,
requests and other communications required or permitted by the terms of this
Agreement to be given to any Person shall be in writing, and any such
communication shall become effective five business days after being deposited in
the mail, certified or registered, with appropriate postage prepaid for first
class mail, or, if delivered by hand or courier service, when received (if
received during normal business hours on a business day, or if not, then on the
next business day), and shall be directed to the following address:

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    If to Buyer:                

AMERICAN ANTIBIOTICS, LLC

6950 Bryan Dairy Road

Largo, Florida 33777

USA

Attention: Dr. Kotha Sekharam, Ph. D., President

   

 

or to such other address as a party may have furnished to the other parties in
writing in accordance herewith, except that notices of change of address shall
only be effective upon receipt.

 

8.5 Counterparts. This Agreement may be executed in two or more counterparts,
and by the different parties hereto in separate counterparts, each of which when
executed shall be deemed to be an original, but all of which together shall
constitute one and the same documents.

 

8.6 Governing Law and Arbitration. This agreement and all issues arising
hereunder or relating hereto, including, without limitation, its construction,
validity, breach, and damages for breach shall be governed by and construed in
accordance with the laws of the State of Maryland (without regard to its
conflict of laws principles). Any action, cause of action, or dispute arising
under or relating to this agreement shall be brought only in the courts of the
state of Maryland or the federal court of the United States and each of the
Parties expressly consents to personal jurisdiction in the State of Maryland
with respect to such action, cause of action, or dispute.

 

8.7 Binding Effect. This Agreement shall be binding upon and shall inure to the
benefit of the parties hereto and their respective successors and assigns.

 

8.8 Severability. Any provision of this Agreement that shall be prohibited or
unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective
to the extent of such prohibition or unenforceability without invalidating the
remaining provisions thereof and any such prohibition or unenforceability in any
jurisdiction shall not invalidate or render unenforceable such provision in any
other jurisdiction. To the extent permitted by applicable law, the parties to
such instrument waive any provision of law that renders any provision thereof
prohibited or unenforceable in any respect.

 

8.9 Headings. The headings contained in this Agreement (including the exhibits
and schedules) are for reference purposes only and shall not affect in any way
the meaning or interpretation of this Agreement.

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8.10 No Agency. Neither party hereto shall be deemed hereunder to be an agent
of, or partner or joint venture with, the other party hereto.

 

8.11 Third Parties. Nothing herein is intended or shall be construed to confer
upon or give to any person other than the parties hereto any rights or remedies
under or by reason of this Agreement.

 

8.12 Exhibits and Schedules. All exhibits and schedules which are attached to
this Agreement are hereby incorporated in this Agreement as though fully set
forth at the respective points indicated in this Agreement. Inclusion of
information in the schedules shall not be construed as an admission that such
information is material to the business. When a reference is made in this
Agreement to a specific schedule, such reference shall be deemed to include, to
the extent applicable, all other schedules, to the extent the disclosure on that
schedule provides full and fair notice of the matter disclosed.

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first above written.

 

AMERICAN ANTIBIOTICS, LLC By:  

/s/ Jugal K. Taneja

   

Jugal K. Taneja, Managing Member

      CONSOLIDATED PHARMACEUTICALS GROUP, INC. By:  

/s/ M.T. Turgut

   

M.T. Turgut