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Exhibit 10.6
TERMINATION OF AGREEMENT DATED SEPTEMBER 12,1990
The Joint
Development Agreement dated September 12,1990 between The
Population Council, Inc. ("The Council")
and National Patent Development
Corporation ("NPDC"), for the joint
development of hydrogel-type polymers as the
vehicle for the controlled parenteral
release of LHRH as amended by the December
11, 1990 letter from Irene Frangos, Esq.,
to Karon Walker, Esq. (the "September
12, 1990 Agreement"), is hereby terminated
in its entirety and superseded with
the following terms and conditions (the
"Agreement").
1. Representations and
Warranties
1.1
Representations and Warranties of The Council. The Council hereby
represents that (a) it is a corporation
duly organized, validly existing and in
good standing under the Not-for-Profit
Corporation Law of the State of New York
and has full corporate power and authority
to execute, deliver and perform this
Agreement; and (b) the execution, deliver
and performance of this Agreement
have been authorized by all necessary
corporate action on the part of The
Council.
1.2
Representations and Warranties of NPDC. NPDC hereby represents and
warrants that (a) it is a corporation duly
organized, validly existing and in
good standing under the laws of the State
of Delaware, and has full corporate
power and authority to execute, deliver and
perform this Agreement; and (b) the
execution, delivery and performance of this
Agreement have been authorized by
all necessary corporate action on the part
of NPDC.
2. Reciprocal Indemnities.
2.1 Reciprocal
Indemnities. NPDC
agrees to hold The Council and its
trustees, officers, agents and employees
(each, a "Council Party") harmless
from, and indemnify it and each of them
against, all Losses of any Council Party
incurred or payable by such Council Party
that result from anything other than
(i) The Council's continuing obligations
under paragraph 3 hereof or (ii) any
Council Party's gross negligence or willful
misconduct. The Council agrees to
hold NPDC and its directors, officers,
agents and employees (each, a "NPDC
Party") harmless from, and indemnify it and
each of them against, all Losses of
any such NPDC Party that result from The
Council's breach or alleged breach of
any representation or warranty made by The
Council contained in this Agreement.
As used herein, "Losses" shall mean, with
respect to any person or entity, any
and all liabilities, losses, damages,
judgments, costs and expenses of any kind
(including reasonable attorneys' fees and
disbursements) which may be imposed
on, incurred by, or asserted against such
person or entity relating to or
arising out of, this Agreement or any
transaction contemplated hereby or the
manufacture, sale or use of any Implant (as
defined below) by NPDC or any
affiliate, officer, agent, employee,
licensee, partner or contract party of
NPDC. This Paragraph 2.1 shall survive the
termination or expiration of this
Agreement.
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2.2 Notice:
Control of Defense.
The Council or NPDC (in this capacity, the
"indemnitee") shall promptly notify the
other party (the "indemnitor") of its
receipt of any threat, indication or other
notice of any claim, suit or demand
which may give rise to any Loss within the
purview of Paragraph 2.1. The
indemnitor shall promptly assume full
control of the defense against any such
claim, suit or demand with the assistance
of counsel reasonably satisfactory to
the indemnitee, and the indemnitee shall
cooperate with indemnitor and such
counsel in the evaluation and defense
thereof, provided that the indemnitor
shall reimburse the indemnitee for its
out-of-pocket expenses (including without
limitation reasonable attorneys' fees and
disbursements) in connection
therewith, which expenses shall not include
the time value of the indemnitee's
employees or management. The indemnitee
will not make any admission of liability
or responsibility, enter into any
settlement, take any other action or incur any
expense (except reasonable attorneys' fees)
with respect to any such claim, suit
or demand without the indemnitor's prior
written consent, which shall not be
unreasonably withheld or delayed.
2.3 Release.
Except with respect to
Paragraphs 5.1 (a) and (b) and 6.1 of
the September 12, 1990 Agreement which
shall survive termination hereof with
respect to any events which occurred prior
to the effective date hereof, whether
such events are known or unknown on the
date hereof, NPDC and The Council
release each other and their respective
heirs, successors, assigns, corporate
parents, subsidiaries, affiliates,
officers, directors, employees and agents
from any and all liability, responsibility,
obligations, damages, expenses, or
claims of any sort at law and in equity,
relating in any way to the September
12, 1990 Agreement.
3. The Council's Continuing Obligations.
The Council's
continuing obligations
concerning the Implants (as that term is
defined in Paragraph 4) shall be
limited to, at the Council's expense, (a)
concluding the ongoing prostate cancer
clinical studies at all investigational
sites according to IND protocols
submitted to the FDA (attached hereto as
Exhibit A)* and (b) providing (or
giving NPDC access to) in a timely fashion,
and in no event more than 30 days
after an NPDC request, such data, records,
materials, and technical and
professional expertise, including but not
limited to the "Council Proprietary
Rights," as that term is defined below, in
the possession of the Council or
under its control, as shall reasonably be
required by NPDC to further the
clinical trials and associated filings,
correspondence and meetings in NPDC's
effort to secure the necessary regulatory
approvals to commercially develop and
market the Implants. Such continuing
obligations shall include those set forth
in Exhibit B, hereto, but shall not
include: the funding or performance of any
clinical trials other than those set forth
in clause 3 (a), above; or the
reimbursement of NPDC for any expenses
incurred in connection with developing
the Implants.
3.1 Council
Proprietary Rights.
"Council Proprietary Rights" shall mean
all ideas, information and intellectual
property, whether or not patentable,
including without limitation physical,
chemical, clinical, toxicological,
performance and other information and data
relating to the Implants or
applications thereof, including such ideas,
information and intellectual
property owned, controlled, developed or
reduced to practice by The Council
prior to the date hereof.
* provided, however,
that the Council shall not, in any case, be required to
enroll any
additional subjects at any such site after the date hereof.
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3.2
Co-Exclusivity. In the
event that NPDC has not (a) submitted by
September 23, 2007, an NDA to the FDA, or
(b) developed and introduced for
commercial sale in the United States by
September 23,2010, in each case, with
respect to an LHRH Implant based in part or
in whole upon Council Proprietary
Rights for application in the treatment of
prostate cancer or symptoms thereof,
then NPDC hereby grants to The Council a
co-exclusive license with NPDC to
develop and market such an LHRH Implant
from and after the applicable such date;
provided, however, that if, on either date
set forth in clause (a) or (b) above,
NPDC demonstrates to the reasonable
satisfaction of The Council that it is
exercising, and will continue to exercise,
due diligence in good faith either to
submit an NDA to the FDA or to develop and
introduce such an LHRH Implant for
commercial sale in the United States, as
applicable, then The Council hereby
agrees to extend for a reasonable time the
applicable date on which such a
co-exclusive license will be granted
pursuant to this Section 3.2.
3.2.1 In the event that NPDC grants to The Council such a
co-exclusive
license, each of The Council and NPDC shall
pay to the other 50% of any
Royalties (as defined in Paragraph 5(d),
below) that each receives from a
Licensee of the LHRH Implant.
3.2.2 In the event that NPDC grants to The Council such a
co-exclusive
license, The Council shall, or shall cause
its Licensee to hold NPDC and its
directors, officers, agents and employees
(each, a "NPDC Party") harmless from,
and indemnify it and each of them against,
all Losses of any NPDC Party incurred
or payable by such NPDC Party that result
from anything other than any NPDC
Party's gross negligence or willful
misconduct.
3.2.3 In the event that NPDC grants to The Council such a
co-exclusive
license, The Council agrees to provide to
NPDC the same certification and right
to audit as are provided to The Council in
Paragraph 5(e) hereto.
3.3 Failure to
Comply. Any failure to
comply with the terms of paragraph 3
(a) and (b) sh
