Exhibit 10.7
Boston Life Sciences License Amendment January
2004 HU 1382
This Amendment to the License
Agreement (this “Amendment”) effective the last day
signed below of 2004, is entered into by and between Boston Life
Sciences, Inc, a corporation organized and existing under the laws
of Massachusetts having its principal offices at 20 Newbury St.,
8th Floor, Boston, MA 02116, (hereinafter, “LICENSEE”)
and Organix Inc. a corporation existing under the laws of
Massachusetts, having its principal offices at 240 Salem Street,
Woburn, MA 01801 (hereinafter “ORGANIX”).
WITNESSETH:
WHEREAS , a License Agreement (the “License
Agreement”) was entered into by and between LICENSEE, ORGANIX
with an effective date of March 15, 2000
WHEREAS , LICENSEE desires to more fully focus its
research and development efforts on two diseases;
WHEREAS , the parties hereto have determined that it is
in their respective best interests to amend Article 1
(“DEFINITIONS”) of the License Agreement to amend the
definition of paragraph 1.2, (“FIELD”), and to amend
Article VII (“FOREIGN AND DOMESTIC PATENT FILING AND
MAINTENANCE”) and Article VIII (“INFRINGEMENT”)
of the License Agreement to more clearly delineate the rights and
responsibilities of the parties hereto;
NOW, THEREFORE
, the parties hereto agree as
follows:
1. Amendment to the License
Agreement .
(a) Paragraph 1.2 is hereby amended
to read:
“FIELD” shall mean .the
diagnosis and/or treatment of (i) Attention Deficit
Hyperactivity Disorder and (ii) Parkinson’s
Disease
(b) Article VII is hereby amended to
read:
PATENT FILING, PROSECUTION AND
MAINTENANCE
7.1 ORGANIX shall own (jointly with
Harvard or other assignees as applicable), file, prosecute and
maintain all U.S. and foreign patent applications and patents
included within the PATENT RIGHTS. LICENSEE shall be included in
all prosecution-related correspondence with outside patent counsel,
shall cooperate with ORGANIX in the prosecution, filing and
maintenance of the PATENT RIGHTS, and shall be promptly copied on
all documents received from or sent to all patent offices involved
in examination, interference proceedings, oppositions and other
matters related to the PATENT RIGHTS. ORGANIX shall consult
LICENSEE on each step of the prosecution process regarding
exclusively licensed PATENT RIGHTS and ORGANIX shall incorporate
LICENSEE’S comments where reasonably practicable, but final
decision making authority shall vest in ORGANIX.
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7.2 Upon execution of this
Agreement, LICENSEE shall reimburse ORGANIX for past and presently
payable patent costs for the preparation, filing, prosecution and
maintenance of PATENT RIGHTS. ORGANIX shall provide to LICENSEE an
itemized invoice of all fees and costs associated with U.S. and
foreign patent prosecution, U.S. and foreign patent annuities, and
all costs associated with any patent interference proceedings
related to the PATENT RIGHTS (“COSTS”) whether such
fees and/or costs were incurred before or after the date of this
Agreement. LICENSEE shall have the opportunity to review said
invoices, and shall have the opportunity to discuss questionable
billings incurred after the EFFECTIVE DATE either with ORGANIX
before ORGANIX pays the invoiced billings, or directly with
ORGANIX’s patent counsel, as ORGANIX directs. As directed by
ORGANIX, LICENSEE shall either pay invoiced billings related to
PATENT RIGHTS directly to ORGANIX’s patent counsel or shall
reimburse to ORGANIX the amount of all fees and costs related to
PATENT RIGHTS that ORGANIX has paid. LICENSEE shall pay to ORGANIX,
or to ORGANIX’s patent counsel if so directed by ORGANIX, all
amounts due under each invoice under this paragraph within thirty
(30) days of the date of receipt of said invoice. Late payment
of these invoices shall be subject to interest
charges of one and
one-half percent (1 1/2%) per month. If ORGANIX shall license
PATENT RIGHTS outside the FIELD to a third party, ORGANIX will pay
to LICENSEE a sum equal to the pro-rata share of past COSTS for
PATENT RIGHTS which are now nonexclusive. ORGANIX will also invoice
present or future COSTS related to nonexclusive patent rights on a
pro rata basis. All pro rata calculations will be made using the
number of distinct companies granted a license(s) and no other
bases.
7.3 ORGANIX, Harvard and LICENSEE
shall cooperate fully in the preparation, filing, prosecution and
maintenance of PATENT RIGHTS exclusive to LICENSEE and of all
patents and patent applications exclusively licensed to LICENSEE
hereunder, executing all papers and instruments or requiring
members of ORGANIX or of Harvard to execute such papers and
instruments so as to enable ORGANIX to apply for, to prosecute and
to maintain patent applications and patents in ORGANIX’s and
other applicable assignees’ names in any country. ORGANIX and
LICENSEE shall each provide to the other prompt notice as to all
matters which come to its attention and which may affect the
preparation, filing, prosecution or maintenance of any such patent
applications or patents. After LICENSEE has shown good and
sufficient cause to justify a request that ORGANIX choose alternate
patent counsel, and after having made reasonable attempts to
rectify the situation resulting in said good and sufficient cause,
ORGANIX will not unreasonably withhold consent that alternate
patent counsel be chosen. In such event, LICENSEE agrees to bear
all costs associated with transfer to alternate patent
counsel.
7.4 LICENSEE may elect to surrender
its PATENT RIGHTS in any country upon one-hundred-twenty
(120) days written notice to ORGANIX. Such notice shall not
relieve LICENSEE from responsibility to reimburse ORGANIX for
patent-related expenses incurred prior to the expiration of the
one-hundred-twenty (120)-day notice period (or such longer period
specified in LICENSEE’S notice).
7.5 In the event ORGANIX elects not
to pursue, maintain or retain a particular PATENT RIGHT licensed to
LICENSEE hereunder, ORGANIX shall so notify LICENSEE in sufficient
time for LICENSEE to assume the filing, prosecution and/or
maintenance of such application or patent at LICENSEE’s
expense. In such event, ORGANIX shall provide to
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LICENSEE any authorization necessary to permit
LICENSEE to pursue and/or maintain such PATENT RIGHT. LICENSEE
shall have no further royalty obligations under this Agreement with
respect to any such PATENT RIGHT.
(c) Article VIII is hereby amended
to read;
INFRINGEMENT
8.1 With respect to any PATENT
RIGHTS that are exclusively licensed to LICENSEE pursuant to this
Agreement, LICENSEE shall have the right to prosecute in its own
name and at its own expense any infringement of such patent, so
long as such license is exclusive at the time of the commencement
of such action. Each party agrees to notify the other parties
promptly of each infringement of such patents of which that party
is or becomes aware. Before LICENSEE commences an action with
respect to any infringement of such patents, LICENSEE shall give
careful consideration to the views of ORGANIX and Harvard and to
potential effects on the public interest in making its decision
whether or not to sue.
8.2 (a) If LICENSEE elects to
commence an action as described above, ORGANIX and Harvard may, to
the extent permitted by law, elect to join as a party in that
action. Regardless of whether ORGANIX or Harvard elects to join as
a party, ORGANIX and Harvard shall cooperate fully with LICENSEE in
connection with any such action.
(b) If ORGANIX or Harvard elects to
join as a party pursuant to subparagraph (a), ORGANIX and/or
Harvard shall jointly control the action with LICENSEE.
(c) LICENSEE shall reimburse ORGANIX
and/or Harvard for any costs ORGANIX and/or Harvard incurs,
including reasonable attorneys’ fees, as part of an action
brought by LICENSEE, irrespective of whether ORGANIX and/or Harvard
becomes a co-plaintiff.
8.3 No settlement, consent judgment
or other voluntary final disposition of the suit may be entered
into without the prior written consent of ORGANIX and Harvard,
which consent shall not be unreasonably withheld.
8.4 Recoveries or reimbursements
from actions commenced pursuant to this Article shall first be
applied to reimburse LICENSEE, ORGANIX and Harvard for litigation
costs. Any remaining recoveries or reimbursements shall be shared
equally b LICENSEE, ORGANIX and Harvard.
8.5 If LICENSEE elects not to
exercise its right to prosecute an infringement of the PATENT
RIGHTS pursuant to this Article, ORGANIX and/or Harvard may do so
at its own expense, controlling such action and retaining all
recoveries therefrom. LICENSEE shall cooperate fully with ORGANIX
and/or Harvard in connection with any such action.
8.6 Without limiting the generality
of paragraph 11.5, ORGANIX may, at its election and by notice to
LICENSEE, establish a time limit of sixty (60) days for
LICENSEE to decide whether to prosecute any infringement of which
ORGANIX and/or Harvard is or becomes aware. If, by the end of such
sixty (60)-day period, LICENSEE has not commenced such an action,
ORGANIX and/or Harvard may prosecute such an infringement at its
own expense,
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controlling such action and retaining all
recoveries therefrom. With respect to any such infringement action
prosecuted by ORGANIX and/or Harvard in good faith, LICENSEE shall
pay over to ORGANIX and/or Harvard any payments (whether or not
designated as “ROYALTIES”) made by the alleged
infringer to LICENSEE under any existing or future SUBLICENSE
authorizing LICENSED PRODUCTS, up to the amount of ORGANIX and/or
Harvard’s unreimbursed litigation expenses (including, but
not limited to, reasonable attorneys’ fees).
8.7 If a declaratory judgment action
is brought naming LICENSEE as a defendant and alleging invalidity
of any of the PATENT RIGHTS, ORGANIX may elect to take over the
sole defense of the action at its own expense. LICENSEE shall
cooperate fully with ORGANIX and Harvard in connection with any
such action.
2. Definitions . Capitalized
terms used in this Amendment that are not otherwise defined herein
shall have the meanings set forth in the License
Agreement.
3. General . Except as
expressly set forth above, the License Agreement as previously
amended remains in full force and effect, without change or
modification.
IN WITNESS WHEREOF, the parties have executed
this Amendment as of the date first set forth above.
For:
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ORGANIX
Inc.
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BOSTON LIFE
SCIENCES, INC.
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/s/ P
ETER C. M ELTZER
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4/30/04
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/s/ M
ARC L ANSER
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5/11/04
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Peter C. Meltzer,
PhD
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Name:
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M Lanser
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President,
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Title:
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President
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240 Salem Street
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Woburn, MA 01801
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LICENSE AGREEMENT
BETWEEN
BOSTON LIFE SCIENCES
INC.
AND
ORGANIX, INC
EFFECTIVE DATE is July 1, 2000
Re: Patent Application #’s USP
5,948,933
Date of Patent: September 7,
1999
“Tropane Analogs and Methods for
Inhibition of Monoamine Transport”
[Harvard Case # 1382]
In consideration of the mutual promises and
covenants set forth below, the parties hereto agree as
follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms
shall have the following meanings:
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1.1
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AFFILIATE: any
company, corporation, or business in which LICENSEE owns or
controls at least fifty percent (50%) of the voting
stock or other ownership. Unless otherwise specified, the term
LICENSEE includes AFFILIATES.
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1.2
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FIELD:
Therapeutics and Diagnostics for the following indications:
Attention Deficit Hyperactivity Disorder, Parkinson’s disease
and Depression. The FIELD specifically excludes Addiction
Disorders.
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1.3
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HARVARD:
President and Fellows of Harvard College, a nonprofit Massachusetts
educational corporation having offices at the Office of Technology
Licensing, Harvard Medical School, Building A – Room 414, 25
Shattuck Street, Boston, Massachusetts 02115.
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1.4
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ORGANIX:
Organix Inc., A Massachusetts corporation having offices at 240
Salem Street, Woburn, MA 01801.
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1.5
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LICENSED
PROCESSES: the processes covered by or utilizing PATENT
RIGHTS.
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1.6
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LICENSED
PRODUCTS: products covered by PATENT RIGHTS or products made or
services provided in accordance with or by means of LICENSED
PROCESSES.
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1
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1.7
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LICENSEE:
Boston Life Sciences Inc., a corporation organized under the laws
of Massachusetts having its principal offices at 137 Newbury St.,
8 th Floor, Boston, MA 02116.
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1.8
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NET SALES: the
amount billed, invoiced, or received (whichever occurs first) for
sales, leases, or other transfers of LICENSED PRODUCTS,
less:
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(a)
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customary
trade, quantity or cash discounts and non-affiliated brokers’
or agents’ commissions actually allowed and taken;
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(b)
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amounts repaid
or credited by reason of rejection or return; and
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(c)
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to the extent
separately stated on purchase orders, invoices, or other documents
of sale, taxes levied on and/or other governmental charges made as
to production, sale, transportation, delivery or use and paid by or
on behalf of LICENSEE or sublicensees;
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(d)
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reasonable
charges for delivery or transportation provided by third parties,
if separately stated.
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NET SALES also includes the fair
market value of any non-cash consideration received by LICENSEE or
sublicensees for the sale, lease, or transfer of LICENSED
PRODUCTS.
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1.9
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NON-COMMERCIAL
RESEARCH PURPOSES: use of PATENT RIGHTS for academic research or
other not-for-profit scholarly purposes which are undertaken at a
non-profit or governmental institution or at ORGANIX that does not
use the PATENT RIGHTS in the production or manufacture of products
for sale or the performance of services for a fee.
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1.10
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NON-COMMERCIAL
CLINICAL PURPOSES: use of PATENT RIGHTS for any purpose related to
patient care at HARVARD, or any not-for-profit hospital affiliated
with HARVARD that does not use the PATENT RIGHTS in the production
or manufacture of products for sale.
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1.11
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NON-ROYALTY
SUBLICENSE INCOME: Sublicense issue fees, sublicense maintenance
fees, sublicense milestone payments, and similar non-royalty
payments made by sublicensees to LICENSEE on account of sublicenses
pursuant to this Agreement.
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1.12
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PATENT RIGHTS:
United States Patent (USP) Serial No. 5,948,933, the
inventions described and claimed therein, and any divisions,
continuations, continuations-in-part to the extent the claims are
directed to subject matter specifically described in USP 5,948,933
and are dominated by the claims of the existing PATENT RIGHTS,
patents issuing thereon or reissues thereof, and any and all
foreign patents and patent applications corresponding thereto, all
to the extent owned or controlled by ORGANIX.
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1.13
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TERRITORY:
Worldwide
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1.14
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The terms
“Public Law 96-517” and “Public Law 98-620”
include all amendments to those statutes.
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1.15
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The terms
“sold” and “sell” include, without
limitation, leases and other transfers and similar
transactions.
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ARTICLE II
REPRESENTATIONS
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2.1
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ORGANIX is
owner by assignment from Drs. Peter Meltzer; Paul Blundell and
Zhengming Chen and HARVARD is owner by assignment from
Dr. Bertha Madras of their entire right, title and interest in
United States Patent 5,948,933 and the foreign patent applications
corresponding thereto, and in the inventions described and claimed
therein.
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2.2
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In an Invention
and License Administration Agreement effective August 1 1997,
HARVARD has appointed ORGANIX their sole and exclusive agent to
license United States Patent 5,948,933 on their behalf. ORGANIX
therefore has the authority to issue licenses under PATENT
RIGHTS.
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2.3
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HARVARD is
committed to the policy that ideas or creative works produced at
HARVARD should be used for the greatest possible public benefit,
and believes that every responsible incentive should be provided
for the prompt introduction of such ideas into public use, all in a
matter consistent with the public interest.
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2.4
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LICENSEE is
prepared and intends to diligently develop the invention and to
bring products to market which are subject to this Agreement.
Thereafter, until the expiration of this Agreement, LICENSEE shall
endeavor to keep LICENSED PRODUCTS available to the
public.
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2.5
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LICENSEE is
desirous of obtaining an exclusive license in the TERRITORY in
order to practice the above-referenced invention covered by PATENT
RIGHTS in the United States and in certain foreign countries, and
to manufacture, use and sell in the commercial market the products
made in accordance therewith, and ORGANIX is desirous of granting
such a license to LICENSEE in accordance with the terms of this
Agreement.
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ARTICLE III
GRANT OF RIGHTS
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3.1
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ORGANIX hereby
grants to LICENSEE and LICENSEE accepts, subject to the terms and
conditions hereof, in the TERRITORY and in the FIELD:
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(a)
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an exclusive commercial license
under PATENT RIGHTS to make and have made, to use and have used, to
sell and have sold, to import and have imported, the LICENSED
PRODUCTS, and to practice the LICENSED PROCESSES, for the life of
the PATENT RIGHTS. Such licenses shall include the right to
grant
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sublicenses, subject to ORGANIX
approval, which approval shall not be unreasonably withheld. In
order to provide LICENSEE with commercial exclusivity for so long
as the license under PATENT RIGHTS remains exclusive, ORGANIX
agrees that it will not grant licenses under PATENT RIGHTS to
others except as required by obligations in paragraph 3.2(a) or as
permitted in paragraph 3.2(b).
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3.2
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The granting
and exercise of this license is subject to the following
conditions:
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(a)
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HARVARD’s
“Statement of Policy in Regard to Inventions, Patents and
Copyrights,” dated August 10, 1998, Public Law 96-517,
Public Law 98-620, and HARVARD’s obligations under agreements
with other sponsors of research. Any right granted in this
Agreement greater than that permitted under Public Law 96-517, or
Public Law 98-620, shall be subject to modification as may be
required to conform to the provisions of those statutes.
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(b)
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ORGANIX and
HARVARD reserve the right to
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(i)
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make and use,
and grant to others non-exclusive licenses to make and use for
NON-COMMERCIAL RESEARCH PURPOSES the subject matter described and
claimed in PATENT RIGHTS; and
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(ii)
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to use the
subject matter described and claimed in PATENT RIGHTS for
NON-COMMERCIAL CLINICAL PURPOSES.
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(c)
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At any time
after two (2) years from the Effective Date of this Agreement,
ORGANIX at its sole discretion may terminate or render this license
non-exclusive if
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