EXHIBIT 2.1
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
EXHIBIT 2.1
AGREEMENT DATED MARCH 23, 2004 BY AND BETWEEN LANNETT COMPANY, INC. AND
XXXXXX XXXXXXX PHARMACEUTICALS, INC.
THIS AGREEMENT is entered into as of this 23rd day of March 2004, by and
between LANNETT COMPANY, INC., a Delaware corporation whose principal office is
at 0000 Xxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 ("LCI"), and XXXXXX XXXXXXX
PHARMACEUTICALS, INC., a New York corporation whose principal office is at 00
XxXxxxx Xxxxx, Xxxxxxx, Xxx Xxxx 00000 ("JSP").
BACKGROUND
JSP represents that it is engaged in the development, supply and
marketing of various pharmaceutical products for human use, and that it is
ready, willing and able to supply LCI with Butalbital with Aspirin, Caffeine and
Codeine Phosphate capsules ("BACC"), Digoxin tablets ("Digoxin") and
Levothyroxine Sodium tablets, as defined in the latest edition of United States
Pharmacopeia, sold under the generic name and the brand name "Unithroid"
("Levothyroxine"). For the purposes hereof, BACC, Digoxin and Levothyroxine are
collectively referred to as the "Products". It is hereby acknowledged that
Unithroid is a trademark and trade name of JSP and is the proprietary property
of JSP. LCI desires to have available on a coordinated, continuing basis the
manufacture of the Products, and JSP is willing to supply the Products for LCI's
use on the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants herein
contained, the parties hereby agree as follows:
1. Purchase and Sale of the Products. On and subject to the terms
hereof: (a) JSP shall supply LCI with all of LCI's requirements for the Products
for distribution within the United States necessary to supply its customers in
accordance with established business practices of LCI; and (b) LCI shall
purchase from JSP its entire requirements of the Products for the United States.
During the term of this Agreement, and in consideration of LCI making diligent
and best efforts within commercial guidelines to meet the Minimum Purchase Order
Volumes set forth in Paragraph 5 below, JSP agrees not to supply or provide the
Products, directly or indirectly, to or for any party other than LCI nor shall
it directly sell the Products to anyone other than LCI. It is understood and
agreed between the parties that JSP may directly sell, supply and/or deliver the
Products to or for the benefit of third parties located outside of the United
States; provided that JSP will make diligent and best efforts to prevent the
products which it sells outside the United States from being diverted back into
the United States.
2. Term. The term of this Agreement begins on March 23, 2004 (the
"Effective Date") and shall continue for a period of ten (10) years thereafter.
3. Price. For the Products in a fully finished form (i.e.,
manufactured, packaged and delivered to LCI hereunder), LCI shall pay JSP the
prices set forth on Exhibit A hereto.
4. Purchase Orders. LCI shall make all purchases hereunder by
submitting firm purchase orders to JSP. Each such purchase order shall be in
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
writing in a form reasonably acceptable to JSP, and shall specify the
description of the particular Product ordered (dosage, strength and tablet
count), the quantity ordered, the place of delivery and the required delivery
date. LCI shall have at all times binding purchase orders for delivery of the
Products for a three (3) month (90 days) period with JSP. In addition, each
order shall be required to have a minimum of forty-five (45) days lead time from
JSP's receipt of a purchase order to date of delivery. All Products supplied
hereunder shall be shipped on a monthly basis, F.O.B. JSP's place of
manufacture, to such location as designated by LCI in the applicable purchase
order. LCI shall pay all freight, insurance charges, taxes, if any, inspection
fees and other charges applicable to the sale and transport of the Products
purchased by LCI hereunder. Title and risk of loss and damages to the Products
purchased hereunder shall pass to LCI upon delivery to the designated commercial
carrier at JSP's place of manufacture.
5. Initial Minimum Purchase Order Volumes. During the ten (10)
years of this Agreement, LCI shall use commercially reasonable efforts to
purchase the following quantities of each Product (by dollar volume)
Levothyroxine Digoxin BACC Total
Year 1 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 2 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 3 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 4 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 5 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 6 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 7 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 8 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 9 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Year 10 [CONFIDENTIAL TREATMENT -- INFORMATION FILED
SEPARATELY WITH THE COMMISSION]
Notwithstanding the foregoing, LCI may satisfy the minimum purchase order
volumes in any year by buying additional quantities of any one of Levothyroxine,
Digoxin or BACC when it cannot meet the requirement for another one of the
Products in that year. JSP shall have the right to terminate this agreement on
sixty (60) days written notice to LCI if LCI fails to purchase from JSP the
total dollar volume of purchases for the Products as set forth in this paragraph
5. Such option to terminate shall be JSP's sole remedy for LCI's failure to meet
the total dollar volume of purchases as set forth in this paragraph 5.
6. Price Increases. Prices may increase, if necessary, up to a
maximum of three (3%) percent per year subsequent to the first year of this
Agreement. The necessity of any price increase shall be determined at the sole
and absolute discretion of JSP. No such price increase or decrease shall apply
to any purchase orders issued before the effective date of such price increase
or decrease. JSP shall provide LCI with at least sixty (60) days prior written
notice before implementing any adjustment in prices.
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
7. Product Requirements. The Products and all components and
ingredients thereof shall be produced in strict accordance with: (a) current
Good Manufacturing Practices (as defined in regulations promulgated by the Food
and Drug Administration ("FDA") under the U.S. Food, Drug and Cosmetic Act, as
amended (the "Act"), and as generally understood and interpreted by the
pharmaceutical industry) ("cGMPs"), and (b) quality control procedures and
associated test methods for the manufacturing process as developed by JSP. Each
of LCI and JSP warrant and guarantee to the other that each article shipped by
them under this Agreement: (i) will not, on the date of shipment, be adulterated
or misbranded (A) within the meaning of the Act, or (B) within the meaning of
any applicable state law in which the definitions of "adulteration" and
"misbranding" are substantially the same as those contained in the Act, as such
laws are constituted and effective at the time of such shipment or delivery and
(ii) will not be an article which may not under the provisions of Section 404 or
505 of the Act be introduced into interstate commerce. Products may only be
shipped if the package configuration is in compliance with the cGMPs and FDA
regulations.
8. Inspections. JSP shall manufacture, fill, package, label and
warehouse the Products in conformity with all applicable rules, laws and
regulations including cGMPs and the specifications for each of the Products
(hereafter, the "Product Specifications"). JSP will evaluate and inspect each
batch of the Products in accordance with cGMPs and the packaging guidelines set
forth in the Product Specifications. LCI, or its designee, may, at its own cost
and expense, with prior reasonable notice and during regular business hours,
visit and inspect the operations and facilities wherein each Product is
manufactured, packaged, tested, labeled and/or stored for shipping.
9. Termination. Either party shall have the right to terminate
this Agreement and/or suspend further performance under this Agreement, without
liability except for unpaid prior delivered Product, if the other party breaches
any of its obligations under this Agreement in any material respect and fails to
cure such breach within thirty (30) days of the written notice from the other
party, identifying the breach with specificity. LCI shall also have the right to
terminate this Agreement and/or suspend further performance under this
Agreement, without liability except for unpaid prior delivered Product, if JSP
loses any approval(s) from the FDA required to perform its obligations under
this Agreement. In no event shall any termination of this Agreement excuse
either party from any breach or violation of this Agreement and full legal and
equitable remedies shall remain available therefore, nor shall it excuse the
making of any payment due under this Agreement with respect to any period prior
to the date of termination.
10. Board of Directors. During the term of this Agreement, JSP
shall be entitled to nominate one person to serve on the Board of Directors of
LCI (the "Board"); provided, however, that the Board shall have the right to
reasonably approve any such nominee in order to fulfill its fiduciary duty by
ascertaining that such person is suitable for membership on the board of a
publicly traded corporation including, but not limited to, complying with the
requirements of the Securities and Exchange Commission, the American Stock
Exchange and applicable law including the Xxxxxxxx-Xxxxx Act of 2002. The
nominee will provide the Board with all requested information regarding such
person's background as is reasonably requested by the Board in order for the
Board to fulfill its fiduciary duties. If, after a thorough review and
consultation with JSP, the Board rejects a JSP nominee, JSP shall have the
opportunity to select an alternate who shall be subject to the same review
process. Subject to the foregoing, at the next regularly scheduled meeting of
the Board, the JSP nominee shall be appointed to the Board to serve until
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
the next regularly scheduled meeting of the stockholders of LCI, at which time
such representative shall stand for election. At each annual meeting of the
stockholders of LCI held during the term of this agreement, Xxxxxxx Xxxxxx shall
vote all of his shares of common stock of LCI in favor of JSP's nominee to the
Board; provided however that such obligation shall only apply for so long as
this Agreement shall remain in full force and effect and provided further that
such obligation shall not be binding on successors in interest to Xxxxxxx
Xxxxxx.
11. Consideration. In consideration of JSP's execution of this
Agreement, LCI shall issue to JSP four million (4,000,000) shares of the common
stock of LCI. The shares of common stock shall be delivered free and clear of
any lien and/or encumbrances, with all required transfer taxes, if any, paid or
provided for. In connection with the issuance of the Shares to JSP, JSP makes
the representations and warranties set forth on Exhibit B to LCI.
Notwithstanding anything to the contrary set forth herein or otherwise, the
obligations of LCI to issue the Shares is subject to the receipt of a fairness
opinion issued by a recognized and reputable investment banking firm to be
selected by the independent members of LCI's board in the exercise of their sole
and absolute discretion opining that the issuance of the Shares and the
concomitant dilution of the ownership interest of LCI's minority shareholders is
fair to such shareholders in view of the Products' contribution or potential
contribution to LCI's profitability. LCI will endeavor to have such opinion
issued within fifteen (15) days of the date hereof. In the event that such an
opinion is not received, then, and in that event, either party will have the
right to cancel this Agreement on written notice to the other as provided in
Paragraph 14 hereof. As additional consideration for this Agreement, and in
recognition of the efforts of JSP to obtain A/B ratings for its products to
Levoxyl and Synthroid, LCI agrees to reimburse JSP for its direct out of pocket
expenses in connection with obtaining such A/B ratings, up to an aggregate
reimbursement of one million five hundred thousand ($1,500,000) dollars.
12. Governing Law. This Agreement shall be interpreted and
construed in accordance with the laws of the Commonwealth of Pennsylvania,
regardless of the laws that might otherwise govern under applicable principles
of the conflicts of law thereof.
13. Relationship of the Parties. Nothing contained in this
Agreement shall be construed to place the parties in the relationship of
partners or joint venturers nor constitute any party the agent of any other
party and neither party shall have the power to obligate or bind the other party
in any manner whatsoever.
14. Notices. All notices, requests, demands and other
communications required or permitted to be made hereunder shall be in writing
and shall be deemed duly given if , sent by registered or certified mail, return
receipt requested, or sent by nationally recognized overnight delivery service,
in each case addressed to the party entitled to receive the same at the address
set forth in the first paragraph of this Agreement. Each communication to be
sent to JSP is to be sent to the attention of Xxxxxx Xxxxxxxxx and each
communication to be sent to LCI is to be sent to the attention of Xxxxxx
Xxxxxxxxx. Either party may alter the address to which communications are to be
sent by giving notice of such change of address in conformity with the
provisions of this Section providing for the giving of notice. Notice shall be
deemed to be effective, if sent by registered or certified mail; and if sent by
nationally recognized overnight delivery service, on the next business day
following delivery to such delivery service. A copy of any notice sent to JSP
shall also be sent to: Xxxxxx X. Xxxxxx, Esq., 0000 Xxxxxxxx Xxxxxxxxx,
Xxxxxxxxx, Xxx Xxxx 00000.
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
A copy of any notice sent to LCI shall also be sent to: Xxxxxxxx X. Xxxxxx,
Esq., Xxxxxx, Xxxxxxx & Xxxxxxx LLP, 000 Xxxxxxxxxxx Xxxxxx, 00xx Xxxxx,
Xxxxxxx, XX 00000.
15. Benefits. Except as set forth in Paragraph 10 hereof, this
Agreement shall be binding upon and shall inure to the benefit of LCI, its
successors and assigns and JSP, and its successors and assigns.
16. Saving Clause. In the event any part of this Agreement is
found to be void or voidable, the remaining provisions of this Agreement shall
nevertheless be binding with the same force and effect as though the void or
voidable part were deleted.
17. Authorization. LCI and JSP represent that each has the full
authority to execute and deliver this Agreement and to carry out the
transactions contemplated herein. The execution and delivery of this Agreement
and the consummation of the transactions contemplated herein have been duly
authorized by the necessary corporate authority.
18. Non-Disclosure of Information; Licensing of Name. LCI
recognizes and acknowledges that JSP's trade secrets, manufacturing processes,
production techniques and other data and information, including the trade name
"Unithroid" relating to the Product (collectively "Confidential Information") as
it may exist from time to time, is a valuable, special and unique asset of JSP
and is JSP's proprietary property. Accordingly, LCI, its officers, directors,
and employees agree to hold all such Confidential Information in strict
confidence and agree not to utilize any Confidential Information for its own
benefit or profit, other than in furtherance of the terms of this Agreement
during the period this Agreement is in full force and effect. During the term of
this Agreement, JSP hereby licenses use of the trade name "Unithroid" to LCI in
connection with its sale of that Product.
19. Indemnification.
JSP's Indemnity Obligations. JSP shall defend, indemnify and hold
harmless LCI, its affiliates and their respective successors and permitted
assigns (and the respective officers, directors, stockholders, partners and
employees of each), from and against any and all losses, liabilities, claims,
actions, proceedings, damages and expenses (including without limitation
reasonable attorneys' fees and expenses) (herein "Damages") relating to or
arising: (a) from the manufacture of the Products; (b) any breach by JSP or its
affiliates of this Agreement, including without limitation, the failure of the
Products to meet all warranties, express or implied or (c) any claims or
infringement or misappropriation relating to any of the Products except to the
extent such Damages give rise to an indemnification claim in favor of JSP as set
forth below.
LCI's Indemnity Obligations. LCI shall defend, indemnify and hold
harmless JSP, its affiliates and their respective successors and permitted
assigns (and the respective officers, directors, stockholders, partners and
employees of each) from and against any and all Damages arising out of the
handling, possession, use, marketing, distribution or sale of any of the
Products by LCI or its affiliates or any of their distributors or agents
following delivery by JSP of the Products to LCI at JSP's shipping point, except
to the extent such Damages give rise to an indemnification claim in favor of LCI
as set forth above.
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed as of the day and year first above written.
LANNETT COMPANY, INC.
By: /s/ Xxxxxx X. Xxxxxxxxx
-----------------------------------
Xxxxxx X. Xxxxxxxxx
Its: President
XXXXXX XXXXXXX PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxxxxx
-----------------------------------
Xxxxxx Xxxxxxxxx
Its: President
Acknowledgement
The undersigned, Xxxxxxx Xxxxxx, executes this agreement for the limited purpose
of agreeing to be bound by the terms and conditions of Paragraph 10 hereof.
/s/ Xxxxxxx Xxxxxx
-----------------------------------
Xxxxxxx Xxxxxx
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
EXHIBIT A
PRODUCT PRICES
Levothyroxine Sodium Tablets and Unithroid Tablets:
0.025 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.050 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.075 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.088 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.100 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.112 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.125 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.150 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.175 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.200 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.300 mg Bottle of 100 [***]
Bottle of 1000 [***]
Digoxin:
0.125 mg Bottle of 100 [***]
Bottle of 1000 [***]
0.250 mg Bottle of 100 [***]
Bottle of 1000 [***]
Butalbital, Aspirin, Caffeine & Codeine: Bottle of 100 [***]
LEGEND: *** - CONFIDENTIAL TREATMENT - INFORMATION
FILED SEPARATELY WITH THE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED BY LANNETT COMPANY, INC.
EXHIBIT B
INVESTOR REPRESENTATIONS
1. In deciding to acquire the Shares, JSP has relied exclusively
upon its own investigation and has not relied upon any offering memoranda or
other similar instruments prepared by LCI, any officer, director or stockholder
of LCI, or any third party. JSP acknowledges that, except as set forth in this
Agreement, no representations or warranties have been made to it, or to its
advisors or representatives, by LCI or others with respect to the business of
LCI, its financial condition or otherwise.
2. The Shares are being acquired by JSP solely for JSP's own
account with the present intention of holding such Shares for purposes of
investment, and that it has no intention of selling such securities in a public
distribution in violation of the Securities Act of 1933, as amended (the "Act"),
or any applicable state securities laws; provided, however, that nothing
contained herein shall prevent JSP and/or any subsequent holders of such Shares
from transferring such Shares in compliance with applicable securities laws.
3. JSP confirms that LCI has made available to JSP, or to
representatives of JSP, the opportunity to ask questions and to acquire such
additional information about the business and financial condition of LCI as JSP
has requested. JSP acknowledges that it is familiar with the operations of LCI,
with its products and services and with its financial condition and prospects.
4. JSP understands and has taken cognizance of all risk factors
related to the purchase of the Common Stock, and its knowledge and experience,
and/or that of its authorized representatives, in financial and business matters
is such that it is, and/or its authorized representatives are, capable of
evaluating the business condition, financial or otherwise, of LCI.
5. JSP can bear the economic risks of this investment and can
afford a complete loss of its investment in the Shares. JSP has no present or
anticipated need for liquidity of its investment in LCI.
6. JSP qualifies as an "accredited investor" as defined in Rule
501 of Regulation D promulgated under the Act.
