Exhibit 10.41
[NOTE : CERTAIN PORTIONS OF THIS DOCUMENT
HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR SUCH PORTIONS BY IMCLONE SYSTEMS INCORPORATED.
THESE PORTIONS HAVE BEEN MARKED WITH TWO ASTERISKS ENCLOSED IN
BRACKETS (i.e. [**]). THE CONFIDENTIAL PORTIONS HAVE BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
AMENDED AND RESTATED LICENSE
AGREEMENT
by
and between
AVENTIS HOLDINGS, INC.
and
IMCLONE SYSTEMS INCORPORATED
Dated December 7, 2007
TABLE OF CONTENTS
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Article No.
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Title
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Page
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RECITALS
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2
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DEFINITIONS
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2
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1.
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LICENSE AND SUBLICENSES
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4
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2.
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DUE
DILIGENCE
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4
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3.
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FEES AND ROYALTIES
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4
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3.
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FEES AND ROYALTIES
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6
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5.
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PATENT PROTECTION
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7
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6.
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TERMINATION
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7
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7.
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REPRESENTATIONS AND WARRANTIES
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8
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8.
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INFRINGEMENT
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8
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9.
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PRODUCT LIABILITY
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9
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10.
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ASSIGNMENT
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9
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11.
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NON-USE OF NAMES
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10
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12.
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PAYMENTS, NOTICES AND OTHER
COMMUNICATIONS
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10
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13.
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CONFIDENTIALITY
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10
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14.
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MISCELLANEOUS PROVISIONS
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11
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Confidential Treatment Requested by ImClone
Systems Incorporated
AMENDED AND RESTATED LICENSE
AGREEMENT
This Amended and Restated License Agreement
(this “Agreement”) is entered into and effective as of
December 7, 2007 (the “Effective Date”) by and
between AVENTIS HOLDINGS, INC., a corporation duly organized and
existing under the laws of Delaware and having its principal office
at 3711 Kennett Pike, Suite 200, Greenville, Delaware 19807
(hereinafter referred to as “AVENTIS”), and IMCLONE
SYSTEMS INCORPORATED, a corporation duly organized under the laws
of the STATE OF DELAWARE and having its principal office at 180
Varick Street, New York, NY 10014 (hereinafter referred to as
“IMCLONE”).
WITNESSETH
WHEREAS, Rhône Poulenc Rorer Inc.
(“RPR”) and IMCLONE
have been parties to that certain License Agreement entered into as
of June 13, 1994 (the “License
Agreement”);
WHEREAS, RPR through a series of intercompany
agreements has assigned to AVENTIS the License Agreement since
April 5, 2004;
WHEREAS, AVENTIS and IMCLONE desire to amend
the License Agreement and to restate the same in its entirety, as
provided in this Agreement;
WHEREAS, Yeda Research and Development Co. Ltd.
(“YEDA”) has initiated legal proceedings in several
countries seeking to change the inventorship and/or ownership of
certain of the U.S. and Non-U.S. Patents and Patent Applications
assigned to RPR (“the Inventorship and Ownership
Proceedings”);
WHEREAS, IMCLONE, Aventis and YEDA have reached
an agreement settling the Inventorship and Ownership Proceedings
(the “Three-Way Settlement”)
WHEREAS, IMCLONE desires to manufacture, use
and sell products which include the use of the Know-how and are
covered by the claims of the Patent Rights, and is willing to
expend its good faith efforts and resources to do so in return for
an exclusive license by AVENTIS to whatever rights remain in
AVENTIS after implementation of the Three-Way
Settlement.
NOW, THEREFORE, in consideration of the
premises and the mutual covenants contained herein, the parties
hereto, intending to be legally bound, agree as follows:
DEFINITIONS
For
the purposes of this Agreement, the following words and phrases
shall have the following meanings:
Confidential Treatment Requested by ImClone
Systems Incorporated
2
“Affiliate” shall mean any
corporation, company or other entity which directly or indirectly
controls or is controlled by, or is under common control with,
IMCLONE or AVENTIS.
“AVENTIS” shall mean AVENTIS and
any subsidiary or Affiliate of AVENTIS.
“Commercial Sale” shall mean the
sale for its intended use of a Licensed Product(s) to a third
party which is not an Affiliate.
“Erbitux®” shall mean
cetuximab (IMC-C225, and marketed as
‘Erbitux®’).
“IMCLONE” shall mean IMCLONE and
any subsidiary or Affiliate of IMCLONE.
“Know-how” means AVENTIS owned or
licensed information and materials useful for the manufacture, use,
regulatory approval of, or sale of the Licensed Product.
“Licensed Product(s)” shall mean
Erbitux®, IMC-11F8 and matuzumab (EMD-72000) as well as all
derivatives, analogs, fragments, improvements, conjugates and
bioequivalents of any of the foregoing.
“Net Sales,” with respect to
particular Licensed Product(s), shall mean the gross amount
received by IMCLONE, its Affiliates, or its sublicensees on all
sales of such Licensed Product(s) less:
[**]
“Patent Rights” shall mean any and
all non-U.S. patents and non-U.S. patent applications that claim
priority to (a) U.S. Patent No. 6,217,866 or (b) any
one or more of the patent applications for U.S. Patent
No. 6,217,866, and any continuations, continuations-in-part,
and division applications thereof, all foreign equivalents thereof,
foreign patents and any reissues, re-examinations or extensions
based thereon or a Supplementary Protection Certificate or the like
in respect thereof.
“Royalty Payment(s)” shall mean the
royalties paid by IMCLONE to AVENTIS under this
Agreement.
“Supplementary Protection
Certificate” shall mean the supplementary protection
certificate for Medicinal products provided under Council
Regulation (EEC) No. 1768/92 of June 18, 1992 and their
equivalents.
Confidential Treatment Requested by ImClone
Systems Incorporated
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ARTICLE 1 - LICENSE AND
SUBLICENSES
1.1
AVENTIS hereby grants to IMCLONE a
worldwide exclusive right and license under Know-how, with the
right to sublicense others, to make, have made, use, sell, offer
for sale and import Licensed Product(s).
1.2
AVENTIS hereby grants to IMCLONE an
exclusive license under Patent Rights, with respect to
AVENTIS’ fifty percent ownership interest in such Patent
Rights, with the right to sublicense others, to make, have made,
use, sell, offer for sale and import Licensed Product(s) in
all jurisdictions outside the United States.
1.3
In the event IMCLONE sublicenses the
rights granted to it under Sections 1.1 or 1.2, IMCLONE shall
remain responsible for all obligations hereunder.
1.4
The license granted herein shall
extend in a country until expiration in such country of the IMCLONE
royalty payment obligations as described in Sections 3.3 and
3.4.
1.5
Except as expressly set forth pursuant
to the foregoing in this ARTICLE 1, neither party shall acquire any
license or other intellectual property interest under this
Agreement, by implication or otherwise, including patents,
know-how, trademarks or copyrights owned or licensed by the other
party or its respective Affiliates.
ARTICLE 2 - DUE
DILIGENCE
2.1
IMCLONE shall use its good faith
efforts to bring the Licensed Product(s) to market. This
good faith efforts requirement will be considered fulfilled if
IMCLONE engages in a thorough, vigorous, and diligent program to
exploit Patent Rights in all appropriate fields of use, which may
include the sublicensing of Patent Rights to better exploit Patent
Rights, as long as such a program is justified as determined by
prudent business practice.
ARTICLE 3 - FEES AND
ROYALTIES
3.1
With the exception of IMCLONE paying a
single lump sum payment of $3,000,000 U.S. dollars to AVENTIS
pursuant to the December 7, 2007 letter agreement between
IMCLONE and AVENTIS (the “Side Letter”), no upfront
license fees shall be due under this Agreement upon the execution
of this Agreement. AVENTIS shall retain all amounts already
paid to it under the License Agreement before the Effective
Date. For the avoidance of doubt, except as expressly set
forth in this ARTICLE 3, no other payments or any milestone or
other royalty or other license payments shall be due from IMCLONE
to AVENTIS in consideration for any licenses or other rights
granted to IMCLONE under this Agreement.
Confidential Treatment Requested by ImClone
Systems Incorporated
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3.2
No other payments or any milestone or
other royalty or other license payments shall be due from IMCLONE
to AVENTIS (a) in respect of any Net Sales in the United
States, or (b) subject to the provisions of Section 3.3
hereunder, with respect to Net Sales in a jurisdiction outside of
the United States where there is no issued patent in the Patent
Right(s) licensed by AVENTIS to IMCLONE hereunder.
3.3
IMCLONE shall pay to AVENTIS a royalty
rate of [**] of Net Sales of Erbitux® outside the United
States, in all oncological uses, and whether or not such sales are
for use as a single pharmaceutical agent or in combination with any
antineoplastic agent, including radiotherapy. Such royalty
obligation shall apply to Net Sales in any and all countries (other
than the United States) in which there exists as of the Effective
Date an unexpired issued patent in the Patent Rights. Such
royalty obligation shall commence on the Effective Date and
thereafter terminate, on a country by country basis, on the later
of (i) January 17, 2017 or such later date secured by a
patent term extension for U.S. Patent No. 6,217,866,
(ii) the expiration of the applicable issued patent in the
Patent Rights including any patent term extension thereof, or
(iii) ten (10) years from the grant of the marketing
approval for Erbitux® in that country (and in such case,
whether or not the marketing approval has been granted to
Erbitux® by the competent authorities in such country as of
the Effective Date).
3.4
IMCLONE shall pay to AVENTIS a royalty
rate of [**] on Net Sales outside the U.S. for all IMC-11F8 and
matuzumab (EMD-72000), in each case in all oncological uses, and
whether or not such sales are for use as a single pharmaceutical
agent or in combination with any antineoplastic agent, including
radiotherapy. Such royalty obligation under this
Section 3.4 shall apply to Net Sales in any and all countries
in the world other than the United States in which there exists as
of the Effective Date an unexpired issued or pending patent in the
Patent Rights. Such royalty obligation under this
Section 3.4 shall commence on the Effective Date and
thereafter terminate, on a country by country basis, on expiration
of the applicable issued patent in the Patent Rights including any
patent term extension thereof.
3.5
No multiple royalties shall be payable
because the Licensed Product(s), its manufacture, lease or sale are
or shall be covered by more than one patent application or patent
licensed under this Agreement.
3.6
Royalty payments shall be paid in
United States dollars at such place as AVENTIS may reasonably
designate consistent with the laws and regulations controlling in
any foreign country. Any withholding taxes that IMCLONE or
any sublicensee shall be required by law to withhold on remittance
of the royalty payments shall be deducted from royalty paid to
AVENTIS. IMCLONE shall furnish AVENTIS the original copies of
all official receipts for such taxes. If any currency
conversion shall be required in connection with the payment of
royalties hereunder, such conversion shall be made by using the
exchange rate reported in the Wall Street Journal for the last day
of the reporting period to which such royalty payments
relate.
Confidential Treatment Requested by ImClone
Systems Incorporated
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3.7
The IMCLONE obligations to pay
royalties to AVENTIS under Sections 3.3 and 3.4 are absolute and
unconditional. IMCLONE shall have no right to withhold payments
partially or totally if and when there is a dispute on the
application of any provision of this Agreement.
ARTICLE 4 - REPORTS AND
RECORDS
4.1(a)
IMCLONE shall keep full, true and
accurate books of account containing all particulars that may be
necessary for the purpose of showing the amount payable to AVENTIS
by way of royalty as aforesaid. Said books of account shall
be kept at IMCLONE’s principal place of business or the
principal place of business of the appropriate division of IMCLONE
to which this Agreement relates. Said books and the
supporting data shall be open at all reasonable times, but not
exceeding [**], for [**] years following the end of the calendar
year to which they pertain, to the inspection of AVENTIS and/or an
independent certified public accountant retained or employed by
AVENTIS for the purpose of verifying IMCLONE’s royalty
statement or complia
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