[Confidential treatment has been requested for portions of this exhibit. The
confidential portions have been redacted and are denoted by [______________].
The confidential portions have been separately filed with the commission.]
AMENDMENT TO JOINT DEVELOPMENT AGREEMENT
This AMENDMENT TO JOINT DEVELOPMENT AGREEMENT (this "Agreement") is made
as of September 30, 1997 by and between ALEXION PHARMACEUTICALS, INC., a
Delaware corporation ("Alexion"), having its principal place of business at 00
Xxxxxxx Xxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxxx 00000, and UNITED STATES
SURGICAL CORPORATION, a Delaware Corporation ("USSC"), having its principal
place of business at 000 Xxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxxx 00000.
Background
X. Xxxxxxx and USSC entered into a Joint Development Agreement dated as of
July 31, 1995 (the "Original Agreement"), pursuant to which Alexion and USSC
established a cooperative arrangement for the development and commercialization
of certain proprietary technology of Alexion relating to [________________].
(Capitalized terms not otherwise defined herein have the meaning given in the
Original Agreement.)
B. In view of (i) the substantial progress made by Alexion toward certain
milestones in the Original Agreement and (ii) certain inventions acquired by
Alexion that may have application in the Field, USSC desires to (a) recognize
Alexion's research and pre-clinical progress by increasing USSC's investment in
Alexion on the terms and conditions set forth in a certain Share Purchase
Agreement being entered into contemporaneously with this Agreement and (b)
obtain exclusive rights to such inventions in the Field, and Alexion and USSC
wish to modify the Original Agreement as set forth below.
In consideration of the premises and of other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties agree as follows:
1. Pre-Clinical Funding
1.1 Subsection 3.4(c)of the Original Agreement is hereby amended by
deleting clauses 3.4(c)(i)(B) and 3.4(c)(ii) in their entirety.
1.2 Subsection 3.4(d) of the Original Agreement is hereby amended by
inserting the following sentence at the beginning of such paragraph: "It is
agreed that two important milestones are the attainment of the DC/HT Milestone
and the Primate Milestone," and by deleting from the first sentence thereof the
phrase "make the payment associated with such milestone or."
2. Amendment of License to Include New Patent Application; Certain
Pigs
2.1 The parties wish to confirm that "Alexion Transplantation
Technology Invention" shall include the invention described in the New Patent
Application (as defined below), which invention shall hereafter be deemed to be
within the scope of the license with respect to Alexion Transplantation
Technology Inventions granted to USSC pursuant to Section 3.5(h) of the Original
Agreement.
2.2 The Disclosure Schedule appended to the Original Agreement is
hereby amended by adding as Patent No. 20. disclosed thereon, the following
patent application and all patents which issue thereon and foreign counterparts
thereof, any continuations, continuations-in-part, divisions, reissues,
reexaminations, additions and renewals of any such applications or patents
(collectively, the "New Patent Application"):
"20. [___________________________________________]
2.3 (a) Notwithstanding the provisions of the Section 6.2 of the
Original Agreement, transgenic pigs produced both (i) under the license to the
New Patent Application granted pursuant to Section 2.2 of this Agreement and
(ii) during the performance of the Research and Development Programs under the
Original Agreement shall be owned by USSC ("USSC Pigs"), with the exclusive
worldwide marketing, sales and distribution rights for the USSC Pigs, subject to
the reservation and retention by Alexion of an undivided co-ownership interest
in all [__________] ("[ ]Constituents"), and the perpetual, royalty-free,
non-transferable right and license to practice all technology of Alexion or in
which it has an interest which may be included in the USSC Pigs for research
purposes, only on a non-commercial basis, and subject to the other provisions of
this Section 2.3.
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(b) USSC's rights to use the USSC Pigs (including [____________]
Constituents) shall be limited to the Field, and by the scope, duration and any
other limitations on USSC's rights to use Transplantation Technology or sell
Products or which is otherwise applicable pursuant to the Original Agreement,
including the licenses granted to USSC with respect to the New Patent
Application.
(c) Alexion shall own the exclusive, worldwide right, with the right
of assignment or license, to make, have made, use and sell transgenic pigs
(other than USSC Pigs) produced under the New Patent Application outside the
Field. Alexion shall have no duty to seek the consent or approval of USSC, nor
to account to USSC, for use of [_____________] Constituents outside the Field or
pursuant to the research license reserved by Alexion. USSC and Alexion each
hereby waives any rights it may now or hereafter have with respect to partition.
(d) USSC shall, at any time and from time to time, upon reasonable
notice and during normal business hours, provide Alexion with
[_____________________], for the purpose of allowing Alexion
[____________________________________] as Alexion may reasonably require.
[___________________________________________]
2.4 (a) All terms defined in the Original Agreement based on or
incorporating, directly or indirectly, the term specified below shall be deemed
modified as follows:
(i) Alexion Transplantation Technology Invention,
including without limitation, the terms Products, Transplantation Technology and
Net Sales, shall be deemed modified to the extent necessary to include the New
Patent Application, and
(ii) Products, including without limitation, the term
Net Sales, shall be deemed modified to the extent necessary to include USSC Pigs
and [____________] Constituents.
(b) The provisions of Section 3.5(n) of the Original Agreement shall
be applicable to transfers or licenses by USSC of rights to USSC Pigs or
[___________] Constituents as if same were Products, and the provisions of
Section 6.4 of the Original Agreement shall set forth the allocation of patent
prosecution
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and litigation responsibilities for USSC Pigs (including Germline Constituents).
2.5 The rights granted to USSC in this Agreement with respect to the
USSC Pigs and [______________] Constituents shall not be construed to confer any
rights upon USSC by implication, estoppel or otherwise as to any technology
licensed to USSC pursuant to the Original Agreement, including the New Patent
Application, or any technology not specifically identified in this Agreement as
or included within such rights, and no other assignments or licenses are made or
granted by implication, estoppel or otherwise, by this Agreement.
2.6 The parties acknowledge and agree that the invention described
in the New Patent Application or a portion thereof, including technology to
create USSC Pigs, was developed with financial or other assistance from the
United States of America, and that applicable statutes, regulations and
Executive Orders of the United States of America may control, apply to or affect
USSC's rights to such technology. Without limiting the foregoing, such license
to, conveyance of, and the rights thereunder of, USSC shall be, with respect to
the New Patent Application and USSC Pigs (including [_______________________]
Constituents), subject to the license and other rights granted to and reserved
by the United States Government pursuant to Section 11 of the General Terms and
Conditions to that certain Advanced Technology Program, Cooperative Agreement
[____________________________________________________________________].
2.7 Subject to Section 2.6 of this Agreement, Alexion hereby makes
and repeats the representations and warranties set forth in Section 8.1 of the
Original Agreement with respect to this Agreement, the New Patent Application
and the USSC Pigs, all of which are true and correct with respect thereto.
ALEXION ALSO HEREBY MAKES AND REPEATS THE EXCLUSIONS AND LIMITATIONS SET FORTH
IN SECTIONS 9.4 AND 9.5 OF THE ORIGINAL AGREEMENT AS SUCH EXCLUSIONS AND
LIMITATIONS PERTAIN TO USSC PIGS (INCLUDING [______________] CONSTITUENTS).
3. Additional Payment.
3.1 Upon the execution hereof, USSC shall pay to Alexion $3,500,000
(the "Additional Payment") by wire transfer in
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good funds in accordance with wire transfer instructions previously provided by
Alexion to USSC.
3.2 The Additional Payment shall be a one-time, non- refundable fee
paid by USSC in consideration for Xxxxxxx'x xxxxx of the foregoing license with
regard to the New Patent Application and rights with regard to USSC Pigs. Such
payment shall not be credited against any royalty payable under Section 3.5(i)
of the Original Agreement or any other amount payable by USSC to Alexion.
4. Effect of this Amendment. Except as expressly amended or modified
hereby, the Original Agreement shall remain in full force and effect.
The parties have caused this Agreement to be signed by their
respective officers as of the date first written above.
ALEXION PHARMACEUTICALS, INC.
By: /s/ XXXXX XXXXXX
----------------------------------------
Name: Xxxxx Xxxxxx
Title: Exec VP & COO
UNITED STATES SURGICAL CORPORATION
By: /s/ XXXXXXX X. XXXXXXXX
----------------------------------------
Name: Xxxxxxx X. Xxxxxxxx
Title: Senior Vice President
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