Exhibit 10.4
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Amendment No. 1 to Research and Commercialization Agreement
This Amendment No. 1 to Research and Commercialization Agreement (the
"Amendment") effective as of January ___, 1999, is entered into by and between
Schering AG ("Schering"), GenPharm International, Inc. and Medarex, Inc.
(collectively, "Medarex"), and amends that certain Research and
Commercialization Agreement entered into by Medarex and Schering effective as of
February 9, 1998 (the "Agreement").
1. All capitalized terms not defined in this Amendment shall have the meanings
given to them in the Agreement.
2. Section 1.3 shall be amended to read in its entirety as follows:
1.3 "Antigen" shall mean each of (i) [*****] as described in the Research
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Plan, (ii) any other antigen proposed by Schering and accepted by
Medarex pursuant to Section 2.1.3.
3. Section 1.16 shall be amended to read in its entirety as follows:
1.16 "Product" shall mean any product for the diagnosis or treatment of
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human disease containing an Antibody or a portion thereof. A Product
used for several indications is considered to be a single Product.
4. Sections 2.1.1, 2.3, 2.4 and 2.7.2 are amended to change each reference to
"the Antigen" to "each Antigen".
5. Section 2.1.2. shall be revised by the addition of the following new last
sentence:
Medarex may, at its sole discretion, with notice to Schering discontinue
any Research Program activities for which Schering is not providing full
research support pursuant to Section 2.2. Within [*****] of such notice,
Schering shall notify Medarex whether Schering wishes to provide research
funding pursuant to Section 2.2 for the activities which Medarex intends to
continue. Unless Schering timely notifies Medarex that Schering will
provide full research funding for such activities, Medarex shall have the
right to discontinue any or all of such activities.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
6. Section 2.1 shall be amended by the addition of the following new Section
2.1.3:
2.1.3 Selection of Antigens. During the Research Program, Schering
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may, with notice to Medarex, propose that one or more new antigens
become Antigens subject to this Agreement. In each case, Schering
shall notify Medarex of the identity of the proposed antigen and
[*****]. Within [*****] after its receipt of any such proposal
and information, Medarex shall notify Schering whether it will
accept the proposed antigen as an Antigen. It is understood and
agreed that Medarex shall have the right, at its sole discretion,
to accept or refuse to accept any such proposed antigen as an
Antigen. At such time as Medarex has accepted [*****] additional
Antigens pursuant to this Section 2.1.3, Schering shall have no
further right to propose additional Antigens, unless otherwise
expressly agreed in writing by the parties.
7. Section 2.5 shall be amended to read in its entirety as follows:
2.5 Research License. Medarex hereby grants to Schering the following
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licenses: [*****] license to use the Antibodies prepared by Medarex
during the Research Period and for which Schering provided Research
support payments pursuant to Section 2.2 [*****] solely for
research and evaluation purposes, and [*****] license to use the
Antibodies with specificity against any Antigen prepared by Medarex
during the Research Period for which Schering did not provide
Research support payments pursuant to Section 2.2. solely for
research and evaluation purposes.
8. Section 3.1.1 shall be amended to read in its entirety as follows:
3.1.1 Option; Right of Negotiation.
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(a) During the Evaluation Period, Schering shall have (i)
an exclusive option to obtain an exclusive (even as to Medarex),
worldwide commercial license as set forth in Section 3.2 solely to
develop Antibodies for which Schering provided Research support
payments pursuant to Section 2.2 for use in the development and
commercialization of Products, and (ii) a right of negotiation as
set forth in Section 3.1.1(b) below to obtain an exclusive (even as
to Medarex), worldwide commercial license as set forth in Section
3.2 solely to develop Antibodies for which Schering did not provide
Research support payments pursuant to Section 2.2 for use in the
development and commercialization of Products. Schering may
exercise such option by notice to Medarex during the foregoing
period specifying [*****] to be covered
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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by the commercial license, and concurrently paying to Medarex the
applicable license fee due pursuant to Section 4.1.
(b) During the Evaluation Period, Schering shall have a right of
negotiation to obtain a commercial license from Medarex with respect
to any Antibodies prepared by Medarex for which Schering did not
provide Research support payments to Medarex as follows: if during the
Evaluation Period, a third party notifies Medarex that such third
party wishes to acquire a commercial license to antibodies directed
against such Antigen, or Medarex wishes to commercialize antibodies
against such Antigen itself, Medarex shall notify Schering; however,
Medarex shall not be obligated to identify such party, whether Medarex
or a third party. If Schering has not notified Medarex within [*****]
days of such notice that Schering will enter a commercial license for
the Antibodies pursuant to Section 3.2 of this Agreement, then
Schering's right of negotiation shall terminate with respect to the
Antibodies and the related Antigen. In any such case, Medarex may
grant one or more third parties commercial licenses with respect to
antibodies specific for the applicable Antigen, or conduct
commercialization of such antibodies itself.
(c) Medarex shall not license, sell, transfer or use in any
manner any Antibodies arising out of the Research to any third party
except Schering. At Schering's request, Medarex shall destroy any
Antibodies, and related Mice Materials prepared by Medarex in the
Research. Notwithstanding the above, it is understood and agreed that
Medarex shall have no obligation to destroy any antibodies and related
Mice Materials for which Schering did not provide research support
payments pursuant to Section 2.2.
9. Section 3.2 shall be amended to read in its entirety as follows:
3.2 Commercial License. Effective upon Schering's election to acquire a
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commercial license, subject to the terms and conditions of this
Agreement (including without limitation, the timely payment of the
license fee due pursuant to Section 4.1) Medarex shall grant to
Schering the following licenses, on an Antigen-by-Antigen basis:
3.2.1 an exclusive (even as to Medarex), worldwide, non-
transferable (except as set forth in Section 14.3), royalty
bearing license under the Medarex Technology with the right
to sublicense, to use hybridomas delivered by Medarex to
Schering to make or have made Antibodies, and
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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3.2.2 an exclusive (even as to Medarex), worldwide, non-
transferable (except as set forth in Section 14.3), royalty
bearing license under the Medarex Technology, with the right
to sublicense, to use Antibodies to make, have made, import,
have imported, use, offer for sale and sell Products.
10. Except as specifically modified or amended hereby, the Agreement shall
remain in full force and effect and, as modified or amended, is hereby
ratified, confirmed and approved. No provision of this Amendment may be
modified or amended except expressly in a writing signed by both parties
nor shall any terms be waived except expressly in a writing signed by the
party charged therewith. This Amendment shall be governed in accordance
with the laws of California, without reference to or application of
conflicts of laws principles.
11. Section 15.17 shall be added to read in its entirety as follows:
15.17 Affiliates. Each Party may perform its obligations hereunder
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personally or through one or more Affiliates, although each Party shall
nevertheless be solely responsible for the performance of its Affiliates.
Neither Party shall permit any of its Affiliates to commit any act
(including any act of omission) which such Party is prohibited hereunder
from committing directly.
IN WITNESS WHEREOF, each of the parties has executed this Amendment as of
the date indicated on this Amendment.
SCHERING AG MEDAREX, INC.
By: Prof. Xx. Xxxxxxx Stock By: /s/ Xxxxxxx Xxxxxxxxx
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Name:_____________________________ Name: Xxxxxxx Xxxxxxxxx
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Title: /s/ G. Stock Title: Executive V.P.
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Member Executive Board of
Directors
Date: 22nd April 1999 Date: May 11, 1999
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SCHERING AG GENPHARM INTERNATIONAL, INC.
By: /s/X.X. Xxxx By: /s/ Xxxxxxx Xxxxxxxxx
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Name: Dr. X-X. Xxxx Name: Xxxxxxx Xxxxxxxxx
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Title: Head of Strategic Business Title: President & C.O.O
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Unit Therapeutics
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Date: 22nd April 1999 Date: May 11, 1999
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