EX-10.1
Confidential Treatment Request [*] indicates information that has been
omitted pursuant to a confidential treatment request and this information has
been filed under separate cover with the Commission.
EXECUTION COPY DECEMBER 12, 2005
INTELLIPHARMACEUTICS CORP.
-AND-
ELITE LABORATORIES, INC.,
-AND-
ELITE PHARMACEUTICALS, INC.
* Portions of this exhibit have been omitted and filed separately pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission, pursuant to Rule 24b-2 under the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 as amended.
EXECUTION COPY DECEMBER 12, 2005
BETWEEN:
INTELLIPHARMACEUTICS CORP.,
30 Worcester Road,
Toronto, Ontario,
Canada M9W 5X2
(referred to herein as "IPC")
-and-
ELITE LABORATORIES, INC., AND ELITE PHARMACEUTICALS, INC.,
165 Ludlow Avenue,
Northvale, NJ
USA 07657
(collectively referred to herein as "Elite")
RECITALS
1. IPC is in the business of the development and commercialization of
controlled release phamaceutical products.
2. Elite is in the business of the development and commercialization of
pharmaceutical products.
3. Elite and IPC have heretofore entered into an agreement, dated June 22,
2005, (the "Intelli-Elite Agreement"), concerning the development and
commercialization of capsules containing delayed release lansoprazole for
Canada, the United States and Mexico.
4. [*] a Canadian company with its head office located at [*] (referred to
herein as "[*]") and IPC intend to enter into an agreement (the
"Intelli-[*] Agreement"), whereby IPC will develop, for and on behalf of
[*], generic Prevacid(R) capsules containing delayed release lansoprazole
(referred to herein as the "Generic Canadian Prevacid(R) Product") for
distribution and sale in Canada only (the "Canadian Development and
Distribution").
5. IntelliPharmaceutics and Elite desire to qualify certain of their
obligations under the Intelli-Elite Agreement in respect of Canadian
development only, as provided herein.
6. Capitalized terms herein which are not otherwise defined shall have the
meaning provided in the Intelli-Elite Agreement.
EXECUTION COPY DECEMBER 12, 2005
-2-
NOW THEREFORE, in consideration of the exchange of mutual promises and covenants
contained in this Agreement, and for other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged by each party, the
Parties hereby agree as follows:
1. Subject to the commencement of commercial sales in Canada, by or on behalf
of [*] or its heirs, assigns or sub-licensees (referred to herein as the
"Canadian Commercialization") of a Generic Canadian Prevacid(R) Product pursuant
to the Intelli-[*] Agreement, the duties and obligations of each of IPC and
Elite under the Intelli-Elite agreement as they pertain to the development and
commercialization in and for Canada of capsules containing a delayed release
lansoprazole generic of Canadian Prevacid(R) (the Canadian Obligations), are
hereby suspended indefinitely, commencing from the date of this Agreement. The
parties hereby release each other from the performance of all such Canadian
Obligations during the full period of such suspension and for a period of thirty
(30) days thereafter.
2. Upon the Canadian Commercialization of Generic Canadian Prevacid(R)
Product, pursuant to the Intelli-[*] Agreement, the suspension of the Canadian
Obligations of each of the parties shall become irrevocably permanent.
3. Upon the Canadian Commercialization of Generic Canadian Prevacid(R)
Product, pursuant to the Intelli-[*] Agreement, and subject to provisions of
paragraph 4 herein, IPC shall pay to Elite from time to time amounts equal to
___ percent (__%) of any payments (other than the milestone payments provided in
Schedule 11.0 of the Intelli-[*] Agreement) received by IPC from the Canadian
Commercialization of Generic Canadian Prevacid(R) Product, as from time to time
become due and owing and are paid to IPC by [*], under Paragraph 11.5 of the
Intelli-[*] Agreement, or by any successor, sublicensee or assignee of the
rights thereafter. IPC will make such payments to Elite within thirty (30) days
of the receipt of such payments by IPC from [*] or its heirs, assigns or
sub-licensees, together with such accounts as IPC receives from [*], its heirs,
assigns or sub-licensees in respect of such payments. The US Dollar equivalent
of such payments to Elite shall be calculated using the rate of exchange between
the currency in question and US dollars as reported in the Wall Street Journal
on the business day immediately proceeding the day that the [*] payment is
received by IntelliPharmaCeutics. A late fee at the rate of [*]% per month shall
be assessed for any late payments of royalties by IPC.
4. Elite hereby agrees that IPC may withhold and retain such amounts, being
equal to [*] percent ([*]%) of any such royalties received, as would be paid to
Elite under Paragraph 3 above, for IPC's sole use and benefit, until such time
as the sum of the amounts withheld and retained is equal to an aggregate of [*]
dollars in United States currency (US$ [*]), after which time IPC shall pay to
Elite the amounts contemplated at Paragraph 3 above.
EXECUTION COPY DECEMBER 12, 2005
-3-
5. If the Intelli-[*] Agreement is terminated for any reason prior to
Canadian Commercialization, the suspension of the Canadian Obligations of both
parties shall be lifted commencing from the thirtieth (30th) day next following
the receipt by Elite from IntelliPharmaCeutics of written notice thereof, and
the Canadian Obligations of Elite and IPC shall then resume in full force and
effect as originally provided in the Intelli-Elite Agreement.
6.
6.1 The Parties agree and confirm that IPC has delivered to Elite, in
strict confidence, an initialed copy of a proposed Intelli-[*] Agreement,
for Elite's review only, for the purposes of considering entering the
Amendment herein (the "Purpose").
6.2 IPC hereby agrees that, upon execution of the Intelli-[*]
Agreement, it will deliver to Elite, in strict confidence, a copy of the
Intelli-[*] Agreement as executed, and warrants that such agreement, as
executed, will have terms substantially identical to those of the initialed
draft now in the hands of Elite.
6.3 Elite hereby acknowledges that all copies of the proposed and
executed Intelli-[*] Agreement were delivered to it in confidence and
agrees that it will so keep them in confidence and will not publish,
disclose or use them in any way except for the Purpose herein contemplated.
7. Elite hereby agrees and confirms that, as between the parties, IPC is the
sole and exclusive owner of all trade secrets, know-how and drug delivery
technology in respect of the Generic Canadian Prevacid(R) Product. Elite hereby
further agrees that, subject to the terms hereof, IPC is fully entitled to
undertake the development of Generic Canadian Prevacid Product as contemplated
in the Intelli-[*] Agreement. IPC hereby agrees to indemnify Elite from all
third party claims against Elite arising out of the Canadian Commercialization
of Generic Canadian Prevacid(R) Product, pursuant to the Intelli-[*] Agreement.
8. The term of this Agreement shall coincide with the term of the Intelli-[*]
Agreement. At such time as [*] or its heirs, assigns or sub-licensees are no
longer obligated to pay royalty payments to IPC in respect of the Canadian
Commercialization of Generic Canadian Prevacid(R) Product, IPC's obligation to
pay to Elite any monies in respect of sales in Canada shall also cease.
9. Notices to each of the parties shall be effective if delivered by pre-paid
registered mail to
IPC CORP.,
30 Worcester Road,
Toronto, Ontario
Canada M9W 5X2
Attention: The President (strictly confidential)
EXECUTION COPY DECEMBER 12, 2005
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ELITE LABORATORIES, INC., AND/OR ELITE PHARMACEUTICALS, INC.,
165 Ludlow Avenue,
Northvale, NJ
USA 07657
Attention: The President (strictly confidential)
10. This Amendment shall be governed by and interpreted in accordance with the
laws of the State of New York, United States of America without regard to their
conflict of laws principles.
11. Except as specifically provided in this Agreement, the Intelli-Elite
Agreement remains unmodified and in full force and effect.
THIS AGREEMENT IS MADE EFFECTIVE AND EXECUTED AS OF THE 12TH DAY OF DECEMBER,
2005 AND SIGNED BY THE DULY AUTHORIZED REPRESENTATIVES OF THE PARTIES.
ELITE PHARMACEUTICALS, INC., IPC CORP.
By: /s/ Bernard Berk By: /s/ Isa Odidi
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Name: Bernard Berk Name: Isa Odidi
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Title: CEO Title: CEO
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December 12, 2005
ELITE LABORATORIES, INC.
By: /s/ Bernard Berk
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Name: Bernard Berk
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Title: CEO
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