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Exhibit 10.5
Execution Copy
AMENDMENT NO. 1 TO COLLABORATION,
DISTRIBUTION AND LICENSE AGREEMENT
This Amendment No. 1 to Collaboration, Distribution and License
Agreement ("Amendment No. 1") is made and effective as of July 15,
2004 by and between Millennium Pharmaceuticals, Inc., a Delaware
corporation, with offices at 40 Landsdowne Street, Cambridge,
Massachusetts 02139-4815, U.S.A. ("Millennium") and Ortho Biotech
Products, L.P., a New Jersey limited partnership, with offices at
Route 22 East, Bridgewater, New Jersey 08807-0914, U.S.A.
("OBI").
INTRODUCTION
A.
The Parties entered into that certain Collaboration, Distribution
and License Agreement effective as of June 30, 2003 (the
"Agreement");
B.
On and subject to the terms and conditions set forth in this
Amendment No. 1 and the Agreement (as amended), Millennium and OBI
therefore desire to amend the Agreement on the terms and conditions
set forth below.
NOW, THEREFORE, for and in consideration of the mutual
convenants contained herein, Millennium and OBI hereby agree as
follows:
1.
Definitions and Cross References . Unless otherwise
specified herein, each capitalized term shall have the meaning
assigned to it in the Agreement and each reference to a Section or
Article shall refer to the corresponding Section or Article in the
Agreement.
2.
New Sections 1.98 and 1.99 . Section 1.98 shall be
renumbered as Section 1.100. The following new Sections 1.98
and 1.99 shall be inserted immediately following Section 1.97:
"Section 1.98 "Millennium Marker Know-How" shall mean any
Millennium Know-How pertaining to (a) markers that (i) relate to
the safety or efficacy of any drug (including combinations of
drugs) and (ii) are derived from, developed or first discovered by
Millennium or on behalf of Millennium by an academic collaborator,
in each case, using patient clinical samples obtained under the
Development Plan, or any Millennium Know-How related to such
patient clinical samples or their use, or any OBI Know-How related
to such patient clinical samples or their use, or (b) any use of
such markers.
Section 1.99 "OBI Marker Know-How" shall mean any OBI
Know-How pertaining to (a) markers that (i) relate to the safety or
efficacy of any drug (including combinations of drugs) and (ii) are
derived from, developed or first discovered by OBI or on behalf of
OBI by an academic collaborator, in each case, using patient
clinical samples obtained under the Development Plan, or any
Millennium Know-How related to such
1
clinical samples or their use, or any OBI
Know-How related to such clinical samples or their use, or (b) any
use of such markers."
3.
Section 3.1(a) . Section 3.1(a) shall be amended by
deleting it in its entirety and replacing it with the
following:
"3.1(a) Development License .
Millennium hereby grants to OBI (i) a co-exclusive (with
Millennium) right and license, with right to grant sublicenses,
under Millennium Intellectual Property, to Develop the Product in
the Field in the License Territory, (ii) a non-exclusive
right and license, with the right to grant sublicenses, under
Millennium Intellectual Property, to Develop the Product in the
Field in the U.S, and (iii) a non-exclusive, fully paid-up right
and license, with the right to grant sublicenses under Millennium
Marker Know-How and Millennium Patent Rights pertaining thereto, to
use and exploit Millennium Marker Know-How for any purpose."
4.
Sections 3.1(d) and 3.1(e) . Sections 3.1(d) and
3.1(e) are amended by inserting "(i), (ii)" immediately following
"3.1(a)" each time such term is used in Section 3.1(d) and 3.1(e)
respectively.
5.
New Section 3.2(d) . The following new Section 3.2(d)
shall be inserted immediately following Section 3.2(c):
"(d) OBI
Marker Know-How and Related OBI Patent Rights . OBI
hereby grants to Millennium, a non-exclusive, fully paid-up right
and license, with the right to grant sublicenses under OBI Marker
Know-How and OBI Patent Rights pertaining thereto, to use and
exploit OBI Marker Know-How for any purpose."
6.
New Section 4.2(f) . The following new Section 4.2(f)
shall be inserted immediately following Section 4.2(e):
"(f) With
respect to each clinical study under the Development Plan where a
Party is responsible for assuming the operational lead for the
Development activities of such study in a particular country or
countries (as set forth in Part I of Exhibit D or as otherwise
agreed by the GPT and approved by the JSC), as appropriate, that
Party may request the other Party to transfer certain of its
obligations under an IND that such other Party owns in the
applicable countries for the purpose of assisting the lead
operational Party in performing such responsibilities.
Subject to the agreement of the Party owning the applicable IND
(the "Transferring Party"), the operational lead Party ("Delegated
Sponsor") will be responsible for the obligations transferred to it
(each, a "Delegated Responsibility" or collectively, "Delegated
Responsibilities"), if any, by the Transferring Party in the
Delegated Sponsor’s role as the designated contract res
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