FIRST AMENDMENT
The First Amendment, effective as of the date set forth above the
signatures of the parties below, amends the Exclusive Patent License Agreement
dated October 24, 1997 ("10/24/97 LICENSE AGREEMENT") between the Massachusetts
Institute of Technology ("M.I.T."), a Massachusetts corporation having its
principal office at 00 Xxxxxxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, 00000,
XXX and Xxxxxx Laboratories, Inc.
WHEREAS, in 1997 Xxxxxx Laboratories, Inc. was renamed Celsion
Corporation, a Maryland corporation having its principal office at 00000-X Xxx
Xxxxxxxx Xxxx, Xxxxxxxx, XX 00000-0000; and
WHEREAS, Celsion Corporation and M.I.T. wish to modify the provisions
of the 10/24/97 LICENSE AGREEMENT.
NOW, THEREFORE, in consideration of the premises and mutual covenants
contained herein, the parties hereby agree to modify the 10/24/97 LICENSE
AGREEMENT as follows:
1. Delete and replace Section 1.5 with the following:
On the EFFECTIVE DATE, "EXCLUSIVE FIELDS OF USE" shall mean FIELD OF USE ONE and
FIELD OF USE TWO. This definition may be modified according to paragraphs 3.6
and 3.7.
2. Delete Sections 1.7 and 1.8 and replace Section 1.7 with the
following:
"FIELD OF USE TWO" shall mean all other medical applications.
3. Delete and replace Section 1.13 with the following:
"LICENSEE" shall mean Celsion Corporation and shall include a related company of
Celsion Corporation, the voting stock of which is directly or indirectly at
least fifty percent (50%) owned or controlled by Celsion Corporation.
4. In Section 1.15, delete "4.1 (h), (i) or (j)" and replace with
"4.1(d), 4.1(e)(i) and 4.1(e)(iii)."
5. In Sections 2.1 and 2.2, delete the words "FIELD OF USE ONE, FIELD
OF USE TWO, AND FIELD OF USE THREE" and replace with "FIELD OF USE ONE and FIELD
OF USE TWO."
6. In Section 2.3(b), delete "twelve (12) years" and replace with
"eighteen (18) years."
7. Delete and replace Section 3.3 with the following
3.3 (a) In addition, pertaining to FIELD OF USE ONE, LICENSEE shall adhere
to the following milestones:
i. as soon as possible, but in all events on or before July 1,
2004, LICENSEE shall make application to the FDA for PMA
approval to commercial sale of a LICENSED PRODUCT and/or the
commercial use of a LICENSED PROCESS and/or commercial
performance of a LICENSED SERVICE in FIELD OF USE ONE; and
ii. as soon as possible, but in all events on or before June 1,
2005, LICENSEE shall make a first commercial sale of a
LICENSED PRODUCT and/or a first commercial use of a LICENSED
PROCESS and/or a first commercial performance of a LICENSED
SERVICE in FIELD OF USE ONE.
(b) Pertaining to FIELD OF USE TWO, LICENSEE shall adhere to the
following milestones:
(i) as soon as possible, but in all events on or before June 1,
2004, LICENSEE shall apply for FDA approval of an IDE for a
LICENSED PRODUCT in FIELD OF USE TWO;
(ii) as soon as possible, but in all events on or before June 1,
2007, LICENSEE shall make application to the FDA for PMA
approval to commercial sale of a LICENSED PRODUCT and/or the
commercial use of a LICENSED PROCESS and/or commercial
1performance of a LICENSED SERVICE in FIELD OF USE TWO; and
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(iii) as soon as possible, but in all events on or before June 1,
2008, LICENSEE shall make, a first commercial sale of a
LICENSED PRODUCT and/or a first commercial use of a LICENSED
PROCESS and/or a first commercial performance of a LICENSED
SERVICE in FIELD OF USE TWO.
8. Delete and replace Section 3.4 with the following:
LICENSEE and its SUBLICENSEES shall make NET SALES according to the following
schedule:
2005 $ (Confidential Treatment Requested)(1)
2006 $ (Confidential Treatment Requested)
2007 $ (Confidential Treatment Requested)
2008 and each year thereafter $ (Confidential Treatment Requested)
9. Delete Section 3.8
10. Delete and replace Section 4.1 with the following:
4.1 Consideration for Grant of Rights
---------------------------------
(a) License Maintenance Fees. LICENSEE shall pay to M.I.T. license
maintenance fees in the manner hereinafter provided to the end of the term of
the PATENT RIGHTS or until this agreement may be terminated:
January 1, 1998 $10,000
----------------------------------
(1) Confidential portions have been omitted and filed separately with the
Commission.
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January 1, 1999 $10,000
January 1, 2000 $25,000
January 1, 2001 $25,000
January 1, 2002 $25,000
January 1, 2003 $25,000
January 1, 2004 $25,000
January 1, 2005 $25,000
January 1, 2006 $50,000
And each January 1 of
Every year thereafter $50,000
This annual license maintenance fee is nonrefundable; however, the
license maintenance fee may be credited to running royalties subsequently due on
NET SALES earned during the same calendar year, if any. License maintenance fees
paid in excess of running royalties due in such calendar year shall not be
creditable to amounts due for future years.
(c) Running Royalties: LICENSEE shall pay to M.I.T. a running royalty
on NET SALES in the amount of:
(i) (Confidential Treatment Requested) percent ((Confidential
Treatment Requested) (2), if the LICENSED PRODUCTS, LICENSED PROCESSES
or LICENSED SERVICES are either made or leased or sold in a country in
which there is a valid, issued claim under the PATENT RIGHTS; AND
(ii) (Confidential Treatment Requested) percent ((Confidential
Treatment Requested)%), if the LICENSED PRODUCTS, LICENSED PROCESSED or
LICENSED SERVICES are neither made nor leased nor sold in a country in
which there is a valid, issued claim under the PATENT RIGHTS, but which
utilize the COPYRIGHT and/or practice or run the PROGRAM, as described
in APPENDIX C.
----------------------------------
(2) Confidential portions have been omitted and filed separately with the
Commission.
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(d) Sharing of Sublicense Income. LICENSEE shall pay M.I.T. a total of
(Confidential Treatment Requested) percent ((Confidential Treatment Requested)
(3) of payments that LICENSEE receives from SUBLICENSEES in consideration of the
sublicense of the rights granted LICENSEE under Section 2, excluding running
royalties on NET SALES of SUBLICENSEES.
(e) Sharing of Other Income. LICENSEE shall pay M.I.T. a total of
(Confidential Treatment Requested) percent ((Confidential Treatment Requested)
%) of: (i) OTHER REVENUE (ii) MILESTONE PAYMENTS; and (iii) Payments that
LICENSEE receives from MEDICAL SERVICE PROVIDERS in consideration for a fully
paid up license and/or authorization to practice LICENSED PROCESSES and perform
LICENSED SERVICES, excluding running royalties on NET SALES of MEDICAL SERVICES
PROVIDERS.
11. In Section 5.2., delete paragraphs (e), (f), (g), (h), (i) and (j)
and replace with the following:
e. Royalties due under paragraphs 4.1(c), (d) and (e); and
f. Names and addresses of all SUBLICENSEES and of all authorized MEDICAL SERVICE
PROVIDERS.
12. In Section 6.3 (a), delete the phrase "paragraphs 4.1(a), (b), and
(c)," and replace with "paragraph 4.1(a)." 13. In Section 6.3 (b),
delete the phrase "paragraphs 4.1(d), (e), and (f)," and replace with
"paragraph 4.1(c)."
----------------------------------
(3) Confidential portions have been omitted and filed separately with the
Commission.
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14. Delete and replace Section 11 with the following:
This Agreement is personal to LICENSEE and no rights or obligations may be
assigned by LICENSEE without the prior written consent of M.I.T., except that
LICENSEE may assign its rights and obligations under this Agreement to a
successor in connection with the merger, consolidation, or sale of all or
substantially all of its assets or that portion of its business to which this
Agreement relates; provided however, that this Agreement shall immediately
terminate if the proposed assignee fails to agree in writing to be bound by the
terms and conditions of this Agreement on or before the effective date of the
assignment.
15. Delete and replace APPENDIX A with the following:
APPENDIX A
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PATENT RIGHTS ON APRIL 1, 2002
------------------------------
UNITED STATES PATENT RIGHTS
---------------------------
M.I.T. Case no. 5493L
U.S. Patent No. 5,251,645, Issued October 12, 1993, Entitled "Adaptive
Nulling Hyperthermia Array."
M.I.T. Case no. 5672L
U.S. Patent No. 5,441,532, Issued August 15, 1995, Entitled "Adaptive
Focusing and Nulling Hyperthermia Annular And Monopole Phased Array
Applicators."
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M.I.T. Case no. 6512L
U.S. Patent No. 5,540,737, Issued July 30, 1996, Entitled "Minimally
Invasive Monopole Phased Array Hyperthermia Applicators For Treating Breast
Carcinomas."
M.I.T. Case no. 7615L
U.S. Patent No. 5810888, Issued September 22, 1998, Entitled
"Thermodynamic Adaptive Phased Array System For Activating Thermosensitive
Liposomes In Targeted Drug Delivery."
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FOREIGN PATENT RIGHTS
---------------------
M.I.T. Case No. 6512L
WO Patent Application Serial No. US94/13564, Filed November 22, 1994,
Entitled, "Minimally Invasive Monopole Phased Array Hyperthermia Aplicators For
Treating Breast Carcinomas". Dormant
CA Patent No. 2177280, Issued November 21, 2000, Entitled, "Minimally
Invasive Monopole Phased Array Hyperthermia Applicators For Treating Breast
Carcinomas."
EP Patent No. 0731721, Issued September 10, 1997, Entitled, "Minimally
Invasive Monopole Phased Array Hyperthermia Applicators For Treating Breast
Carcinomas."
GB Patent No. 0731721, Issued September 10, 1997, Entitled, "Minimally
Invasive Monopole Phased Array Hyperthermia Applicators For Treating Breast
Carcinomas."
DE Patent No. 0731721, Issued September 10, 1997, Entitled, "Minimally
Invasive Monopole Phased Array Hyperthermia Applicators For Treating Breast
Carcinomas."
HK Patent Application Serial No. 98101911, Filed November 22, 1994,
Entitled, "Minimally Invasive Monopole Phased Array Hyperthermia Applicators For
Treating Breast Carcinomas."
M.I.T. Case No. 7615L
CA Patent Application Serial No. 2294196, Filed June 25, 1998, Entitled
"Thermodynamic Adaptive Phased Array System For Activating Thermosensitive
Liposomes In Targeted Drug Delivery."
EP Patent Application Serial No. 98930502.4, Filed June 25, 1998,
Entitled "Thermodynamic Adaptive Phased Array System For Activating
Thermosensitive Liposomes In Targeted Drug Delivery."
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CN Patent Application Serial No. 98808511.9, Filed June 25, 1998,
Entitled "Thermodynamic Adaptive Phased Array System For Activating
Thermosensitive Liposomes In Targeted Drug Delivery."
JP Patent Application Serial No. 11-505720, Filed June 25, 1998,
Entitled "Thermodynamic Adaptive Phased Array System For Activating
Thermosensitive Liposomes In Targeted Drug Delivery."
14. APPENDIX B shall be deleted and replaced with the following:
APPENDIX B
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Foreign countries in which PATENT RIGHTS shall be filed, prosecuted and
maintained in accordance with Article 6:
For M.I.T. Case No. 6512L: Canada, United Kingdom, Germany and Hong Kong. M.I.T.
Case No. 7615L: Canada, China, Japan, Europe
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed under seal by their duly authorized representatives.
The Effective Date of this First Amendment is May 23, 2002.
MASSACHUSETTS INSTITUTE OF CELSION CORPORATION
TECHNOLOGY
By: /s/ Xxxxx Xxxxxx By: /s/ Xxxxxxx X. Xxxxxx
------------------------------- ---------------------------
Name: Xxxxx Xxxxxx Name: Xxxxxxx X. Xxxxxx
Title: Director, Title: Executive Vice President
Technology Licensing Office Finance & Administration
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