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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superseded with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) sha
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