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Title: |
Development and License Agreement |
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Date: |
2001 |
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Preview shows 16KB of 109KB total |
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$50 |
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#274620 |
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DEVELOPMENT AND LICENSE AGREEMENT
AS AMENDED AS OF APRIL 1, 2001
BETWEEN
IMMUNOMEDICS, INC.
AND
AMGEN INC./1/
_________________________
/1/ Legend: [* ] connotes material that has been omitted pursuant to a request
------
for confidential treatment. Such omitted material has been filed separately on a
confidential basis with the Office of the Secretary of the Securities and
Exchange Commission.
{PAGE}
TABLE OF CONTENTS
{TABLE}
{CAPTION}
SECTION TITLE PAGES
------- ----- -----
{S} {C}
Section One - DEFINITIONS
1.1........................................................... 2
Section Two - LICENSES
2.1 - 2.4..................................................... 2
Section Three - ASSIGNMENT
3.1........................................................... 2
Section Four - [*] AGREEMENTS
4.1........................................................... 3
Section Five - EXCLUSIVITY
5.1 - 5.4..................................................... 3
Section Six - TECHNOLOGY TRANSFER
6.1 - 6.3..................................................... 3 - 4
Section Seven - [*] RIGHTS
7.1 - 7.5..................................................... 4 - 5
Section Eight - [*] PRODUCTS
8.1 - 8.3..................................................... 5 - 6
Section Nine - SIGNING FEE
9.1........................................................... 6
Section Ten - CLINICAL MILESTONES
10.1 - 10.3................................................... 6 - 7
Section Eleven - ROYALTIES
11.1 - 11.9................................................... 7 - 10
{/TABLE}
-i-
{PAGE}
TABLE OF CONTENTS (cont'd)
{TABLE}
{CAPTION}
SECTION TITLE PAGES
------- ----- -----
{S} {C}
Section Twelve - SALES MILESTONES
12.1 - 12.2................................................... 10 - 11
Section Thirteen - NO FURTHER CONSIDERATION
13.1.......................................................... 11
Section Fourteen - PAYMENTS
14.1 - 14.6................................................... 11 - 12
Section Fifteen - DEVELOPMENT
15.1 - 15.8................................................... 12 - 14
Section Sixteen - MANUFACTURING
16.1 - 16.7................................................... 14 - 17
Section Seventeen - COMMERCIALIZATION
17.1.......................................................... 17
Section Eighteen - DILIGENCE
18.1 - 18.5................................................... 17 - 19
Section Nineteen - INTELLECTUAL PROPERTY
19.1 - 19.6................................................... 19 - 25
Section Twenty - INSURANCE; INDEMNIFICATION
20.1 - 20.4................................................... 25 - 26
Section Twenty-One - TERM; TERMINATION
21.1 - 21.5................................................... 26 - 30
{/TABLE}
-ii-
{PAGE}
TABLE OF CONTENTS (cont'd)
{TABLE}
{CAPTION}
SECTION TITLE PAGES
------- ----- -----
{S} {C}
Section Twenty-Two - CONFIDENTIALITY
22.1 - 22.3........................................... 30 - 31
Section Twenty-Three - PERMITTED DISCLOSURE
23.1.................................................. 31
Section Twenty-Four - PUBLICATIONS
24.1 - 24.4........................................... 31 - 33
Section Twenty-Five - PUBLIC ANNOUNCEMENTS
25.1 - 25.2........................................... 33
Section Twenty-Six - THIS AGREEMENT
26.1.................................................. 33 - 34
Section Twenty-Seven - TRANSITION
27.1.................................................. 34
Section Twenty-Eight - REPRESENTATIONS, WARRANTIES AND
COVENANTS
28.1 - 28.4........................................... 34 - 36
Section Twenty-Nine - HSR
29.1 - 29.3........................................... 36
Section Thirty - EFFECTIVENESS
30.1.................................................. 36
Section Thirty-One - COSTS AND EXPENSES
31.1.................................................. 36
Section Thirty-Two - GENERAL
32.1 - 32.15.......................................... 36 - 39
{/TABLE}
-iii-
{PAGE}
TABLE OF CONTENTS (cont'd)
{TABLE}
{CAPTION}
SECTION TITLE PAGES
------- ----- -----
{S} {C}
Exhibit A - GLOSSARY................................... A-1 to A-8
Exhibit B - [*] PATENT RIGHTS,
[*] PATENT RIGHTS AND
LICENSED TRADEMARK RIGHTS.................. B-1 to B-2
Exhibit C - LIST OF DEVELOPMENT CONTRACTS.............. C-1 to C-_
Exhibit D - [*] AGREEMENT............................. D-1 to D-26
Exhibit E - [*] AGREEMENT............................. E-1 to E-21
Exhibit F - PRESS RELEASE.............................. F-1 to F-3
SCHEDULE
{/TABLE}
-iv-
{PAGE}
DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT (this "Agreement"), entered into
with an effective date of December 17, 2000 (the "Effective Date"), as amended
as of April 1, 2001, is by and between Immunomedics, Inc., a Delaware
corporation with its principal place of business at 300 American Road, Morris
Plains, New Jersey 07950, and Amgen Inc., a Delaware corporation, with its
principal place of business at One Amgen Center Drive, Thousand Oaks, California
91320-1799.
RECITALS
WHEREAS, Amgen has substantial experience and expertise in developing,
marketing, distributing and selling pharmaceutical products;
WHEREAS, the parties, having successfully concluded negotiations, desire to
enter into a business relationship respecting the research, development and
commercialization of certain antibody-based products, the consummation of which
is contingent on and subject to the satisfaction of applicable legal
requirements under the Hart-Scott-Rodino Act;
WHEREAS, the parties desire to enter into a legal and binding agreement
respecting the terms and conditions under which Immunomedics and Amgen are
prepared to conduct such business relationship, upon the satisfaction of such
legal requirements;
NOW, THEREFORE, the parties in consideration of the mutual representations,
warranties and covenants contained herein and for other good and valuable
consideration, and intending to enter into a legal and binding agreement, hereby
agree to the terms and conditions of this Agreement and the accompanying
Exhibits and Schedule, all of which are incorporated herein by reference.
In consideration of the foregoing, the parties agree as follows:
1.0 DEFINITIONS
1.1 Unless otherwise provided herein, each capitalized term used herein shall
have the meaning assigned to it in the Glossary attached hereto as Exhibit A.
2.0 LICENSES
2.1 Immunomedics grants to Amgen an exclusive license, with the right to
sublicense, under Licensed Patent Rights, Licensed Trademark Rights and Licensed
Know-How, to make, have made, use, sell, lease, offer to sell or lease, import,
export (within the Territory) or otherwise exploit, or transfer physical
possession of or title in, Product(s) in the Field in the Territory.
2.2 Upon Amgen's request, Immunomedics shall negotiate with [*], and Amgen
shall have the right to participate with Immunomedics in negotiations for (and
Amgen shall have right to
-1-
{PAGE}
approve, which approval will not be unreasonably withheld or delayed), license
agreement(s) relating to intellectual property in the Territory claiming [*].
2.3 Upon Amgen's request, Immunomedics (a) shall negotiate with [*] to grant
Amgen an exclusive sublicense to Immunomedics' rights and obligations under the
[*] in the Field in the Territory and/or (b) shall terminate the [*]. Other than
with respect to the [*] Agreements, nothing in this Agreement shall restrict the
right of Immunomedics, after the Closing Date, to enter into one or more
separate agreements with [*] to conduct clinical trials with [*] solely outside
of the Territory.
2.4 In addition to the exclusive license and other rights granted to Amgen in
this Agreement, Immunomedics grants to Amgen a non-exclusive, irrevocable,
perpetual, compensation-free and [*] right and license, without the right to
sublicense, to make, have made, and use Licensed Know-How, for Amgen's internal
research and development purposes only.
3.0 ASSIGNMENT
3.1 Except with respect to the [*] Agreements, Immunomedics hereby assigns to
Amgen, free and clear of encumbrance, all right, title and interest in all [*]
Contracts, Governmental Approvals and Regulatory Filings owned or controlled in
each case by Immunomedics on the Closing Date, which are accepted in writing by
Amgen. In the event such [*] Contracts are not freely assignable by
Immunomedics, Immunomedics shall use reasonable commercial efforts to work with
the contracting party in order to obtain an assignment to Amgen. Notwithstanding
any of the foregoing, Immunomedics shall disclose in writing and provide to
Amgen copies of all [*] Contracts, Governmental Approvals and Regulatory Filings
not later than [*] days following the Closing Date, and only those accepted in
writing by Amgen (in its sole discretion) within[*] days of receipt shall be
assigned to and accepted by Amgen, and thereafter the accepted [*] Contracts
shall be listed in Exhibit C.
4.0 [*] AGREEMENTS
[*]
5.0 EXCLUSIVITY
5.1 Immunomedics shall not grant any right, license, consent, or privilege to
any Third Party or otherwise undertake any action, either directly or
indirectly, that would conflict with any of the rights of Amgen or the
obligations of Immunomedics hereunder.
5.2 Except as to the extent of Immunomedics' Retained Rights or its obligations
to Amgen as explicitly set forth in this Agreement, Immunomedics shall not,
either by itself and/or through a Third Party, make, have made, use, sell,
lease, offer to sell or lease, import, export (within the Territory) or
otherwise exploit, or transfer physical possession of or title in (or otherwise
directly or indirectly engage in any activity or take any action with respect
to), any and all CD22-Based Compound(s) and CD 22 Ligand-based Compound(s) in
the Field or in the field of [*] in the Territory.
-2-
{PAGE}
5.3 Neither Party shall take any action with respect to Product(s) and Licensed
Know-How, Licensed Patent Rights and Licensed Trademark Rights, except to the
extent explicitly permitted under this Agreement.
5.4 During the term of this Agreement, Amgen shall not clinically develop or
commercialize any CD22-Based Compound(s) or CD22 Ligand-based Compound(s), other
than Product(s), in the Field and in the Territory without either electing (and
promptly notifying Immunomedics of Amgen's decision) to (i) include any such
CD22-Based Compound(s) and/or CD22 Ligand-based Compound(s) within the
definition of "Product(s)" in (A.39 of Exhibit A), subject to the terms of this
Agreement or (ii) terminate this Agreement under Section 21.2.1 and return the
rights to Product(s) hereunder to Immunomedics.
6.0 TECHNOLOGY TRANSFER
6.1 Within [*] after the Closing Date, Immunomedics shall transfer to Amgen the
[*] which Immunomedics uses [*].
6.2 Promptly, but in no event more than [*] after the Closing Date,
Immunomedics shall transfer to Amgen such Immunomedics Know-How as follows:
6.2.1 all information, in writing (or in another mutually-agreed tangible
form) in a detail sufficient to enable Amgen to practice the rights and licenses
granted to it under this Agreement (including, but not limited to, its license
and manufacturing rights and other rights and obligations hereunder); and
6.2.2 all Materials sufficient to enable Amgen to practice the rights and
licenses granted to it under this Agreement (including, but not limited to, its
license and manufacturing rights and other rights and obligations hereunder),
including Epratuzumab and [*], in a sufficient quantity and with associated
data and information in a detail sufficient to permit Amgen to [*].
6.3 Other than the transition activities set forth in this Agreement (e.g.,
activities covered in this Section 6.0 and in Section 27.0), Amgen may request
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