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AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

AMENDED AND RESTATED LICENSE AGREEMENT | Document Parties: IMCLONE SYSTEMS INC | AVENTIS HOLDINGS, INC | IMCLONE SYSTEMS INCORPORATED You are currently viewing:
This License Agreement involves

IMCLONE SYSTEMS INC | AVENTIS HOLDINGS, INC | IMCLONE SYSTEMS INCORPORATED

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Title: AMENDED AND RESTATED LICENSE AGREEMENT
Governing Law: New York     Date: 2/29/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED LICENSE AGREEMENT, Parties: imclone systems inc , aventis holdings  inc , imclone systems incorporated
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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

 

Article No.

 

Title

 

Page

 

 

 

 

 

 

 

RECITALS

 

2

 

 

DEFINITIONS

 

2

1.

 

LICENSE AND SUBLICENSES

 

4

2.

 

DUE DILIGENCE

 

4

3.

 

FEES AND ROYALTIES

 

4

3.

 

FEES AND ROYALTIES

 

6

5.

 

PATENT PROTECTION

 

7

6.

 

TERMINATION

 

7

7.

 

REPRESENTATIONS AND WARRANTIES

 

8

8.

 

INFRINGEMENT

 

8

9.

 

PRODUCT LIABILITY

 

9

10.

 

ASSIGNMENT

 

9

11.

 

NON-USE OF NAMES

 

10

12.

 

PAYMENTS, NOTICES AND OTHER COMMUNICATIONS

 

10

13.

 

CONFIDENTIALITY

 

10

14.

 

MISCELLANEOUS PROVISIONS

 

11

 

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

 

3



 

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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