EXHIBIT 10.65
LICENSE AND SUBLICENSE AGREEMENT
This Agreement is entered into as of August 2, 2000 between Licensor
AMBI Inc., a New York corporation ("AMBI"), and Licensee Biosynexus
Incorporated, a Delaware corporation ("BIO") (collectively the "parties").
WHEREAS, AMBI has developed, and has maintained as confidential,
certain valuable AMBI PROPRIETARY INFORMATION, hereinafter defined, with respect
to the manufacture, use, and sale of NISIN PREPARATIONS, hereinafter defined,
and LICENSED PRODUCTS, hereinafter defined; and
WHEREAS, AMBI is licensed by Xxxxx & Xxxxxxx Limited ("A&B") under, and
has maintained as confidential, certain valuable A&B PROPRIETARY INFORMATION,
hereinafter defined, relating to the manufacture of NISIN PREPARATIONS; and
WHEREAS, BIO desires the right to use AMBI PROPRIETARY INFORMATION and
A&B PROPRIETARY INFORMATION (collectively, "PROPRIETARY INFORMATION") in (i) the
manufacture of NISIN PREPARATIONS for use in LICENSED PRODUCTS, and (ii) the
manufacture, use, and sale of the LICENSED PRODUCTS; and
WHEREAS, AMBI has obtained, or may obtain, patents encompassed by the
PATENTED TECHNOLOGY, hereinafter defined, for certain inventions relating to the
manufacture, use, and sale of the NISIN PREPARATIONS and the LICENSED PRODUCTS;
and
WHEREAS, BIO desires the right to use the inventions claimed in
PATENTED TECHNOLOGY in the manufacture, use, and sale of the NISIN PREPARATIONS
and LICENSED PRODUCTS.
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NOW THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties hereby agree as
follows:
1 CERTAIN DEFINITIONS
1.1 "AFFILIATE' shall mean any corporation or other business entity
which directly or indirectly controls, is controlled by, or is under common
control with a party. Control means ownership or other beneficial interest in
50% or more of the voting stock or other voting interest of a corporation or
other business entity.
1.2 "EXCLUDED PRODUCTS" shall mean all products comprising,
incorporating, or relating to NISIN PREPARATIONS for the fields of application
that are described by the general classifications listed in Exhibit A-2 attached
hereto.
1.3 "LICENSED PRODUCTS" shall mean the AMBI products listed in Exhibit
A-1 attached hereto.
1.4 "NET SALES" means BIO's and its AFFILIATES, and their direct and
indirect sublicensees (the "BIO Group"), gross sales to a non-AFFILIATE third
party, less rejections and returns; and customary allowances, credits, and
quantity and cash discounts; and distributors', agents', and brokers' fees or
commissions; and prepaid freight; and separately invoiced insurance,
transportation, and taxes and other governmental charges.
1.5 "NISIN PREPARATIONS" shall mean any and all raw material forms,
variants, or derivatives of nisin.
1.6 "PATENTED TECHNOLOGY" shall mean AMBI patents and pending patent
applications as of the date of this Agreement, and patents which may issue on
any such applications, relating to the
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manufacture and use of NISIN PREPARATIONS or the LICENSED PRODUCTS, including
any U.S. patents listed in Exhibit C, and their foreign equivalents.
1.7 "A&B PROPRIETARY INFORMATION" shall mean all secret or confidential
business and/or technical information relating to NISIN PREPARATIONS, as listed
in Exhibit B1, which have been licensed by A&B to AMBI.
1.8 "AMBI PROPRIETARY INFORMATION" shall mean all secret or
confidential business and/or technical information relating to NISIN
PREPARATIONS, or the LICENSED PRODUCTS, as listed in Exhibit B2, but such term
excludes A&B PROPRIETARY INFORMATION.
1.9 "PROPRIETARY INFORMATION" means, collectively, A&B PROPRIETARY
INFORMATION and AMBI PROPRIETARY INFORMATION.
1.10 "A&B TECHNICAL INFORMATION" shall mean technical information other
than the PROPRIETARY INFORMATION and the PATENTED TECHNOLOGY within AMBI's
control, relating to the manufacture of NISIN PREPARATIONS, which have been
licensed by A&B to AMBI.
1.11 "AMBI TECHNICAL INFORMATION" shall mean technical information
other than the PROPRIETARY INFORMATION and the PATENTED TECHNOLOGY within AMBI's
control, relating to the manufacture of NISIN PREPARATIONS and LICENSED
PRODUCTS, but such term excludes A&B TECHNICAL INFORMATION.
1.12 "TECHNICAL INFORMATION" means, collectively, A&B TECHNICAL
INFORMATION and AMBI TECHNICAL INFORMATION.
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2 SCOPE OF LICENSE GRANT
2.1 Subject to all the terms and limitations of this Agreement, AMBI
grants to BIO the sole and exclusive, perpetual, transferable and sublicensable
to the extent set forth in Section 11.3, and world-wide rights and licenses to
use AMBI PROPRIETARY INFORMATION, AMBI TECHNICAL INFORMATION and PATENTED
TECHNOLOGY for manufacture of NISIN PREPARATIONS for use in the LICENSED
PRODUCTS and in developing, manufacturing, having manufactured, using, selling,
marketing, or distributing the LICENSED PRODUCTS.
2.2 (a) Subject to all the terms and limitations of this Agreement, but
without limiting in any way the grant of the rights and licenses set forth in
Section 2.1, AMBI grants to BIO the non-exclusive, perpetual, non-transferable
sublicense, without the right to sublicense (but with the right to cause AMBI to
sublicense as set forth below), to use A&B PROPRIETARY INFORMATION and A&B
TECHNICAL INFORMATION, for manufacture of NISIN PREPARATIONS for use in the
LICENSED PRODUCTS and in developing, manufacturing, having manufactured, using,
selling, marketing, or distributing the LICENSED PRODUCTS. The rights
sublicensed hereunder are referred to as the "Sublicensed Rights."
(b) AMBI agrees upon the request from time to time of BIO or its
transferees or sublicensees (a "Requesting Entity") further to sublicense the
Sublicensed Rights to any person or entity to whom a Requesting Entity has made
a permitted transfer or sublicense under this Agreement.
2.3 Notwithstanding the foregoing, AMBI and BIO agree that the right to
have NISIN PREPARATIONS made by a third party is limited to a third party that
1) is not a person or entity involved in the manufacture of any EXCLUDED PRODUCT
for other than A&B or its affiliates, and 2) is otherwise consistent with
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the scope of the license and obligations under this Agreement, and further
provided that BIO shall provide notice of each such third party to AMBI at least
thirty (30) days prior to the proposed date for entering into an agreement with
any such third party, and shall, at AMBI's request, provide a copy of any such
third party agreement to AMBI.
2.5 AMBI and BIO agree that this Agreement does not include the right
of BIO to develop, manufacture, have made, use, sell, or distribute the EXCLUDED
PRODUCTS, or to sell NISIN PREPARATIONS as such except to AMBI or its
designee(s).
3 PAYMENTS
3.1 Initial License Fee - BIO shall pay to AMBI upon the effective date
of this Agreement (the "Effective Date"), an initial license fee of $(***).
3.2 Continuation License Fee - BIO shall pay to AMBI no later than six
(6) months from the Effective Date, a continuation license fee of $(***).
3.3 Annual Licensee Fees - An annual license fee of $(***) shall be
paid by BIO to AMBI within thirty (30) days of each anniversary of the Effective
Date for a period of eighteen (18) years (corresponding to the number of years
until U.S. Patent 5,985,823 expires). Royalties paid during the twelve (12)
month period prior to each anniversary of this Agreement, are creditable against
the annual license fee for that twelve month period.
3.4 Royalties - BIO shall pay to AMBI royalties on all NET SALES of
each LICENSED PRODUCT, that are made at any time from and after the date of
commercial launch of such LICENSED
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PRODUCT, and such royalty payments shall continue for such LICENSED PRODUCT for
a period of eighteen (18) years from the Effective Date of this Agreement.
Royalties are payable on NET SALES during each year beginning from the first day
of the month in which the Effective Date falls, at the following rates:
NET SALES up to $25 million (***)%
NET SALES greater than $25 million up to $100 million (***)%
NET SALES greater than $100,000 million (***)%
3.5 BIO shall maintain records of each NET SALE of a LICENSED PRODUCT
for not less than seven (7) years after such NET SALE. Such records shall be
sufficient to enable royalties payable to AMBI to be determined accurately.
3.6 BIO agrees to make written reports to AMBI quarterly within thirty
(30) days after the end of each calendar quarter stating by product the quantity
of and NET SALES of each LICENSED PRODUCT sold by the BIO Group during such
quarter and a calculation of royalty due to AMBI, and shall include with each
report payment of the royalty due.
3.7 Without limiting any of AMBI's rights and remedies for any delay or
failure to make royalty payments when due, payments required under this
Agreement which are delinquent shall bear a late payment charge of one and
one-half percent per month or the maximum lawful rate, whichever is lower.
3.8 AMBI shall be entitled to audit the BIO Group's records from time
to time at AMBI's expense to the extent necessary to verify the reports provided
for herein, provided that AMBI may not exercise such audit right more than once
in any calendar year, and such audit may only be conducted during normal
business hours following fifteen (15) days prior written notice. Such audit is
to be made by an independent certified public
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accountant, mutually acceptable to BIO and to AMBI, who shall report to BIO and
AMBI the amount of royalty payable for the period under audit. If the audit
shows an overpayment, such overpayment shall be credited to future royalties. If
the audit shows an underpayment, BIO shall make payment of such amount to AMBI
within thirty (30) days of receiving the audit report. If either party disagrees
with the results of the audit, the party that disagrees shall notify the other
party within thirty (30) days of receipt of the audit report and the parties
shall endeavor in accordance with Section 11 to amicably resolve the dispute
within a reasonable period of time. If the parties can not agree to a resolution
within ninety (90) days of the receipt of the audit report, the matter shall
then proceed to arbitration in accordance with Section 11.5.2.
3.9 Milestone Payments - The following Milestone Payments are to be
made within thirty (30) days after each Milestone Event set forth below. BIO
shall pay to AMBI the amount set forth opposite such Milestone Event.
Milestone Event Payment
(1) Filing of first Investigational
New Drug Application ("IND") or
equivalent in the U.S. or another country $(***)
(2) Initiation of first clinical trial in
which efficacy data will be collected $(***)
(3) Submission of first New Drug Application
("NDA") or equivalent in U.S. or another
country $(***)
(4) Upon each approval of an NDA or its equivalent
in the U.S., each European Union country,
and Japan ("Major Market Country") $(***)
(5) Upon each approval of an NDA or its equivalent in each of the first ten
(10) countries other than a Major Market Country ("Minor Market
Country) $(***)
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The total payments under (4) and (5) above for NDA or equivalent
approvals in Major Market Countries and Minor Market Countries shall
not exceed $(***).
3.10 NISIN PREPARATION INVENTORY - AMBI shall provide one (1) kilogram
of nisin to BIO promptly after payment of the Initial Licensee Fee. AMBI shall
thereafter sell, upon request of BIO, up to nine (9) kilograms of nisin for
$(***) per kilogram.
4 TRANSFER OF PROPRIETARY INFORMATION
4.1 AMBI shall furnish to BIO, promptly after the effective date of
this Agreement, the PROPRIETARY INFORMATION, PATENTED TECHNOLOGY, and TECHNICAL
INFORMATION relating to manufacture of NISIN PREPARATIONS.
4.2 To the extent that the PROPRIETARY INFORMATION is provided in
documentary form, including written, graphic, or machine readable form, at least
the first page of any such document, or the label attached to any such machine
readable form, shall be suitably marked by AMBI to indicate its confidential
nature.
4.3 BIO agrees that, to the extent any document provided by AMBI and
marked in accordance with Section 4.2 is copied or otherwise reproduced, in
whole or in part, each copy or reproduction will be marked by the BIO Group to
indicate its confidential nature.
4.4 All PROPRIETARY INFORMATION shall remain at all times
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the property of AMBI. All PROPRIETARY INFORMATION shall not be used by the BIO
Group beyond the scope of the licenses granted under this Agreement.
5 IMPROVEMENTS
5.1 Any inventions, modifications or improvements to, or applications
of, the PROPRIETARY INFORMATION or the PATENTED TECHNOLOGY relating to the
manufacture, modification or use of NISIN PREPARATIONS and/or their uses in any
of the LICENSED PRODUCTS discovered or made by BIO ("BIO Developments") shall be
promptly disclosed to AMBI, and shall be owned by AMBI, and shall be deemed
exclusively licensed to BIO in accordance with the licenses granted by AMBI to
BIO under this Agreement, and otherwise consistent with the scope of the
licenses and obligations under this Agreement. For the avoidance of doubt, AMBI
at any time use BIO Developments in developing, manufacturing, having
manufactured, using, selling, marketing or distributing products for which BIO
does not then have exclusive rights hereunder, e.g., NISIN PREPARATIONS and the
EXCLUDED PRODUCTS.
6 CONFIDENTIALITY
6.1 BIO recognizes that PROPRIETARY INFORMATION is critical to the
business of AMBI and that AMBI would not enter into this Agreement without
assurance that such PROPRIETARY INFORMATION and the value thereof will be
protected as provided in this Section 6 and elsewhere in this Agreement.
Accordingly, BIO agrees and shall obtain from the BIO Group agreement, as
follows:
6.2 The BIO Group shall hold PROPRIETARY INFORMATION in confidence
and to take all precautions with respect thereto.
6.3 BIO shall not divulge, release, disseminate, or
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otherwise disclose any PROPRIETARY INFORMATION, or any information derived
therefrom, to any third party, except as permitted under and in accordance with
Section 2.
6.4 Notwithstanding the foregoing, the preceding covenants shall not
apply to any PROPRIETARY INFORMATION which the BIO Group can establish:
6.4.1 Is in or (through no improper action or inaction by the
BIO, its agents or employees) enters the public domain;
6.4.2 Was rightfully in BIO's possession or known by it prior
to receipt from AMBI, as evidenced by documentation in BIO's
possession, which documentation is provided to AMBI within thirty (30)
days of BIO's receipt of PROPRIETARY INFORMATION;
6.4.3 Was rightfully disclosed to BIO, without restriction, by
a third party whose direct or indirect source is not AMBI; or
6.4.4 Was independently developed by BIO without access to or
use of any PROPRIETARY INFORMATION.
6.5 Immediately upon termination of BIO's license under Sections 9.2,
9.3 or 9.4, BIO shall, at AMBI's option, turn over to AMBI, or arrange for turn
over by the BIO Group to AMBI, or arrange for destruction of, all documents or
media containing any PROPRIETARY INFORMATION and any and all copies or extracts
thereof and BIO and the BIO Group will make no further use of any kind of any of
the PROPRIETARY INFORMATION.
6.6 BIO acknowledges and agrees that due to the unique nature of AMBI's
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PROPRIETARY INFORMATION, there can be no
adequate remedy at law for any breach
of its obligations hereunder, that any such breach may result in irreparable
harm to AMBI and therefore, that upon any such breach or any threat thereof,
AMBI shall be entitled to appropriate equitable relief in addition to whatever
remedies it might have at law.
6.7 AMBI acknowledges and agrees that BIO may be required in the course
of soliciting financing, establishing joint ventures and strategic alliances,
sublicensing AMBI's PROPRIETARY INFORMATION, AMBI's TECHNICAL INFORMATION or
PATENTED TECHNOLOGY, or otherwise entering into agreements to manufacture, use,
sell, market, or distribute the LICENSED PRODUCTS to disclose all or a part of
AMBI's PROPRIETARY INFORMATION. In connection with any such disclosure, BIO
shall limit the disclosure of any of AMBI's PROPRIETARY INFORMATION to parties
who in BIO's reasonable judgment have a need to know such AMBI PROPRIETARY
INFORMATION for purposes of this Agreement, and who are, with respect to such
AMBI PROPRIETARY INFORMATION, bound in writing by confidentiality terms no less
restrictive than those contained herein, and agree to limit the use of the AMBI
PROPRIETARY INFORMATION and AMBI TECHNICAL INFORMATION solely to determining
whether to enter into a business relationship with BIO. BIO shall provide copies
of such written agreements to AMBI upon request; provided, however, that such
copies shall themselves be deemed AMBI PROPRIETARY INFORMATION.
7 PATENT PROSECUTION AND MAINTENANCE
7.1 AMBI shall continue prosecution of pending patent applications and
shall maintain the PATENTED TECHNOLOGY. During the term of this Agreement, any
decision to discontinue prosecution of a pending patent application or to
discontinue maintenance of the PATENTED TECHNOLOGY shall require the agreement
of BIO. BIO shall pay for all of AMBI's reasonable out of pocket expenses for
the prosecution and maintenance of the
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PATENTED TECHNOLOGY, i.e., all patents and patent applications relating to NISIN
or its manufacture or use ("Patent Payments"). Payments to outside counsel with
respect to patent prosecution within the U.S. Patent and Trademark Office and
foreign patent offices, and payments of maintenance fees, and payments for
activities undertaken at BIO's request or with BIO's concurrence are deemed
reasonable. AMBI shall have the right to make the Patent Payments and to xxxx
BIO (without markup) for the Patent Payments, and BIO shall pay the amounts for
Patent Payments to AMBI within thirty (30) days of AMBI's invoice for the Patent
Payments.
8 BIO AFFILIATIONS
8.1 BIO shall pay to AMBI promptly upon receipt, and in kind, the
Applicable Percentage of all Non-Royalty Consideration which BIO receives at any
time prior to the fourth anniversary of the Effective Date in respect of a
Triggering Transaction.
8.2 Certain Definitions.
8.2.1 The term "Triggering Transaction" means a transaction in
which any third party (a "Transaction Payor") pays consideration to BIO
principally for NISIN PREPARATIONS or LICENSED PRODUCTS or any license
granted hereunder by AMBI to BIO, but only if, after giving effect to
such transaction, BIO owns 50% or less of the ownership and profit
sharing interest in the license granted hereunder by AMBI to BIO or in
all NET SALES made from time to time by the Transaction Payor or its
AFFILIATES.
8.2.2 "Non-Royalty Consideration" means any cash or stock or
other asset or property which BIO at any time receives directly or
indirectly from any Transaction Payor, other than running royalties
based on Net Sales. Without
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limiting the generality of the foregoing, Non-Royalty Consideration includes:
(i) amounts paid by a Payor for any assets, capital stock or
debt or other interest or securities in or of BIO or as consideration
for the contribution by BIO of certain assets to a joint venture with
the Payor or AFFILIATES of the Payor;
(ii) off-balance sheet financings; (iii) research payments and
reimbursements; (iv) license fees; and (v) option fees and
option exercise payments.
8.2.3 "Applicable Percentage" means 25% for Non-Royalty
Consideration received by BIO during the first year after the Effective
Date; 20% of such amounts received in the second year after the
Effective Date; 15% of such amounts received in the third year after
the Effective Date; and 10% of such amounts received in the fourth year
after the Effective Date.
8.3 From and after any Triggering Transaction, should a Transaction
Payor or its AFFILIATES be obligated (whether as a sublicensee or otherwise) to
pay royalties to AMBI in respect of NET SALES made by the Transaction Payor or
its AFFILIATES, such royalties shall be paid to AMBI at the rate provided in
Section 3.3, except that for any Triggering Transaction entered into prior to
the third anniversary of the Effective Date, such royalties shall be paid to
AMBI at the rate provided in Section 3.3 plus 1%.
8.4 Until the fourth anniversary of the Effective Date, BIO shall give
to AMBI not less than 30 days' prior notice before BIO enters into or agrees to
enter into any Triggering Transaction. BIO shall also forthwith provide to AMBI
accurate copies of all
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agreements, instruments and documents from time to time signed by BIO in respect
of any Triggering Transaction, and a detailed report of any Non-Royalty
Consideration paid or payable in respect thereof.
9 TERM AND TERMINATION
9.1 This Agreement will remain in effect for a period of eighteen (18)
years from the Effective Date, unless terminated earlier pursuant to Sections
9.2, 9.3 or 9.4.
9.2 BIO may terminate this Agreement at any time upon one hundred
eighty (180) days prior written notice.
9.3 If a party breaches a material provision of this Agreement, then in
addition to such other rights and remedies as may be available to the aggrieved
party, the aggrieved party may terminate this Agreement upon sixty (60) days
prior written notice unless the breach is cured within such period or, if the
breach cannot reasonably be so cured, diligent efforts to effect such cure are
commenced during that period and are continued in a diligent manner until the
cure is completed, which shall be within a reasonable time.
9.4 If BIO does not make Reasonable Efforts (as defined below") to
develop and commercialize a LICENSED PRODUCT in a Major Market Country, all
licenses and rights with respect to such LICENSED PRODUCTS shall terminate and
revert to AMBI. Reasonable Efforts shall include (i) appropriate pre-clinical
and clinical testing; and (ii) regulatory submission upon satisfactory
completion of clinical testing. Failure to engage in any of these activities in
a meaningful way for a continuous period of six months shall be evidence of lack
of reasonable effort.
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9.5 In the event of any termination of this Agreement under Sections
9.2, 9.3, or 9.4, the rights and licenses granted BIO under this Agreement shall
terminate and BIO shall have no further obligations to AMBI associated with
NISIN PREPARATIONS or LICENSED PRODUCTS, except (1) for BIO's obligations under
Section 6, as well as obligations imposed by BIO on a third party, to maintain
the confidentiality of PROPRIETARY INFORMATION and TECHNICAL INFORMATION shall
survive such termination,(2) for payments of amounts owed as of termination, and
(3) for return of PROPRIETARY INFORMATION and TECHNICAL INFORMATION. All rights
relating to PROPRIETARY INFORMATION, TECHNICAL INFORMATION, and PATENTED
TECHNOLOGY shall revert to AMBI, and AMBI shall have the right to use BIO
Developments for any and all purposes. In addition, BIO shall upon termination
of the license after six (6) months from the Effective Date for any reason other
than expiration or a material breach of the Agreement by AMBI, pay to AMBI a
one-time termination fee of $(***) regardless of whether there are three (3)
years left on the original term of the license, BIO will make payments to AMBI
regarding any royalty obligations incurred but not yet paid, and BIO will be
obligated to make any payments due to AMBI as the result of an Affiliation
entered into prior to the termination of the license and owing as of the date
thereof; provided, however, that other than described in this paragraph BIO
shall have no ongoing payment obligations to AMBI after the termination (for any
reason) of the license agreement.
9.6 In the event of a termination of this Agreement, AMBI shall retain
all payments made prior to the date of termination and all payments to be made
after termination.
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10 REPRESENTATIONS AND WARRANTIES
10.1 AMBI represents and warrants that it has full power, authority and
legal right to enter into and perform this Agreement and to grant to BIO the
rights and licenses set forth herein; that the execution, delivery and
performance of this Agreement have been duly authorized by all necessary
corporate action on its part; and that the execution, delivery and performance
of this Agreement do not contravene any law, governmental rule, regulation or
order binding on AMBI or contravene its charter or by-laws or any material
indenture, mortgage or contract or other agreement to which it is a party or by
which it is bound and which could reasonably be expected to have a material
adverse effect on the ability of AMBI to fulfill its obligations under the
Agreement.
10.2 BIO represents and warrants that it has full power, authority and
legal right to enter into and perform this Agreement; that the execution,
delivery and performance of this Agreement have been duly authorized by all
necessary corporate action on its part; and that the execution, delivery and
performance of this Agreement do not contravene any law, governmental rule,
regulation or order binding on BIO or contravene its charter or by-laws or any
material indenture, mortgage or contract or other agreement to which it is a
party or by which it is bound and which could reasonably be expected to have a
material adverse effect on the ability of BIO to fulfill its obligations under
the Agreement.
10.3 AMBI represents and warrants that AMBI owns or has the right to
license or sublicense, as applicable, the PROPRIETARY INFORMATION and PATENTED
TECHNOLOGY to BIO to the extent set forth in this License Agreement.
10.4 WARRANTY DISCLAIMER - EXCEPT AS OTHERWISE SET FORTH
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HEREIN, AMBI MAKES NO WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES,
RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
11 MISCELLANEOUS
11.1 Infringement Issues; Indemnification
11.1.1 Intellectual Property Indemnity.
11.1.1.1 AMBI agrees, at its own expense, to defend
or, at its option, to settle, any claim or action brought against BIO to the
extent it is based on a claim that BIO's use of the LICENSED PRODUCTS (which
term for all purposes of this Section 11.1 does not include any product which
either (A) is not claimed in an issued patent referred to in Section 1.7 or (B)
if claimed in an issued patent referred to in Section 1.7, is combined with or
uses products, processes or materials which are not the subject matter of any
such claim) or PATENTED TECHNOLOGY (which term for all purposes of this Section
11.1 does not include any PATENTED TECHNOLOGY (as defined in Section 1.7) which
relates to the manufacture or use of any product other than LICENSED PRODUCTS as
defined for the purposes of this Section 11.1) in accordance with the scope of
this Agreement infringes or violates any United States patent, United States
copyright, trademark, trade secret or other intellectual property right of a
third party, and will indemnify and hold BIO harmless from and against any
damages, costs and fees of any kind whatsoever incurred (including reasonable
attorneys' fees) that are attributable to such claim or action. BIO agrees that
AMBI shall have the foregoing obligation only if BIO provides AMBI with: (i)
prompt written notification of the claim or action; (ii) sole control and
authority over the defense or settlement thereof (and will consult with BIO with
respect thereto to the extent
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reasonably practicable); and (iii) all available information, assistance and
authority to settle and/or defend any such claim or action (all at AMBI's sole
cost and expense). BIO shall have the right, at its expense, to participate in
any such claim through counsel of its choice.
11.1.1.2 If any LICENSED PRODUCTS or PATENTED
TECHNOLOGY becomes, or in the opinion of AMBI is likely to become, the subject
of an infringement claim or action, AMBI may procure, at no cost to BIO, the
right to continue using the LICENSED PRODUCTS or PATENTED TECHNOLOGY. If BIO is
enjoined, by order of a court or other governmental body, from using the
LICENSED PRODUCTS or PATENTED TECHNOLOGY as contemplated by this Agreement as a
result of an infringement claim or action, then AMBI may, at its sole option:
(i) procure, at no cost to BIO, the right to continue using the LICENSED
PRODUCTS or PATENTED TECHNOLOGY; (ii) replace or modify the LICENSED PRODUCTS or
PATENTED TECHNOLOGY to render it noninfringing, provided there is no material
loss of utility; or (iii) if, in AMBI's reasonable opinion, neither (i) nor (ii)
are commercially feasible terminate the license and refund the amounts BIO paid
for such LICENSED PRODUCTS or PATENTED TECHNOLOGY. Except as provided in Section
11.1.1.1, the foregoing provisions of this Section 11.1.1.2 state AMBI's sole
obligation and BIO's exclusive remedy in the event of any such claim.
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11.1.1.3 AMBI will have no liability under this
Section 11.1.1 or the limited warranty provided for in Section 10.3, for any
claim or action where: (i) such claim or action would have been avoided but for
modifications of the LICENSED PRODUCTS or PATENTED TECHNOLOGY, or portions
thereof, made by any party other than AMBI (or any third party retained by AMBI)
after delivery to BIO; (ii) such claim or action would have been avoided but for
the combination or use of the LICENSED PRODUCTS or PATENTED TECHNOLOGY, or
portions thereof, with other products, processes or materials; (iii) after BIO
is enjoined from using the LICENSED PRODUCTS or PATENTED TECHNOLOGY, BIO
continues allegedly infringing activities after being notified thereof (provided
that BIO shall also indemnify AMBI against liabilities incurred by AMBI as a
result of BIO continuing to engage in allegedly infringing activities after
being notified thereof, but prior to being enjoined from using the LICENSED
PRODUCTS or PATENTED TECHNOLOGY); (iv) BIO continues allegedly infringing
activities after being informed of modifications that would have avoided the
alleged infringement, provided that there is not material loss of functionality;
or(v) BIO's use of the LICENSED PRODUCTS or PATENTED TECHNOLOGY is not strictly
in accordance with the terms of this Agreement. BIO agrees to indemnify and hold
AMBI harmless from and against all losses, damages and expenses, including
reasonable attorney's fees, in connection with any claims brought against AMBI
and its officers, employees, agents or subcontractors arising as a result of any
of the conditions described in clauses (i) through (v) above. AMBI agrees that
BIO shall be released from the foregoing obligation unless AMBI provides BIO
with: (i) prompt written notification of the claim or action; (ii) sole control
and authority over the defense or settlement thereof; and (iii) all available
information, assistance and authority to settle and/or defend any such claim or
action.
19
11.2 General Indemnity - Each party shall indemnify the other and hold
the other harmless for and against any and all loss, damage, costs or expenses
(including legal costs and expenses) incurred by the other party by reason of
any breach of any provision of this Agreement.
11.3 Independent Contractors - The parties are independent contractors
and not partners, joint venturers or otherwise affiliated and neither has any
right or authority to bind the other in any way.
11.4 Assignment - AMBI may assign or transfer its rights and
obligations under this Agreement. BIO may assign or transfer its rights and
obligations under this Agreement to 1) BIO's AFFILIATES, or 2) to successors to
BIO's business interests by the sale or merger of substantially all of BIO's
assets relating to the LICENSED PRODUCTS, and BIO may sublicense its rights
under Section 2.1 and may disclose PROPRIETARY INFORMATION and TECHNICAL
INFORMATION (but may not sublicense its rights under Section 2.2), provided that
the assignee or transferee or successor or sublicensee or disclosee 1) is not a
person or entity involved in the manufacture of any EXCLUDED PRODUCTS for other
than A&B, and 2) is not a person or entity manufacturing any NISIN PREPARATIONS
for sale or delivery other than to, or on behalf of, BIO, A&B or AMBI, and 3)
assumes the obligations of assignor by instrument reasonably satisfactory to
AMBI. In any event, any such assignment, transfer, sublicense or disclosure is
permitted hereunder only if it is consistent with the scope of the license and
obligations under this Agreement, and BIO provides notice of each such third
party to AMBI no later than 30 days prior to entering into an agreement with any
such third party, and, at AMBI's request, provides a copy of any such third
party agreement to AMBI. No assignment, transfer, sublicense or disclosure shall
relieve the assignor, transferor, sublicensor or disclosor of any obligation
under this Agreement.
20
11.5 Amendment and Waiver - Except as otherwise expressly provided
herein, any provision of this Agreement may be amended and the observance of any
provision of this Agreement may be waived (either generally or any particular
instance and either retroactively or prospectively) only with the written
consent of the parties.
11.5 Resolution of Disputes
11.5.1 Negotiation Between Executives - The parties shall
attempt in good faith to resolve any dispute arising out of or relating
to this Agreement, or the breach, termination or validity thereof, by
negotiations between Chief Executive Officers or their designees who
have authority to settle the controversy. Any party may give the other
party written notice of any dispute not resolved in the normal course
of business. Within 20 days after delivery of such notice, executives
of both parties shall meet at a mutually acceptable time and place, and
thereafter as often as they reasonably deem necessary, to exchange
relevant information and to attempt to resolve the dispute. If the
matter has not been resolved within 60 days of the disputing party's
notice, or if the parties fail to meet within 20 days, either party may
initiate arbitration of the controversy or claim as provided
hereinafter.
If a negotiator intends to be accompanied at a meeting by an
attorney, the other negotiator shall be given at least three working
days' notice of such intention and may also be accompanied by an
attorney. All negotiations pursuant to this clause are confidential and
shall be treated as compromise and settlement negotiations for purposes
of the Federal Rules of Evidence and state rules of evidence.
21
11.5.2 Arbitration - If a dispute arising out of or relating
to this Agreement, or the breach, termination or validity thereof, has
not been resolved by negotiation as provided herein, it shall be
settled by arbitration in accordance with the Center for Public
Resources Institute for Dispute Resolution Rules for Non-Administered
Arbitration of Business Disputes. The arbitration shall take place in
New York City, New York, shall be governed by the United States
Arbitration Act, 9 U.S.C. xx.xx. 1-16, and judgment upon the award
rendered by the arbitrator may be entered by any court having
jurisdiction thereof.
11.6 Governing Law and Legal Actions - This Agreement shall be governed
by and construed under the domestic laws of the State of New York.
11.7 Jurisdiction and Venue - The parties agree not to contest personal
jurisdiction and further agree that any action initiated relating to this
Agreement shall be filed in the United States District Court for the Southern
District of New York.
11.8 Headings - Headings and captions are for convenience only and are
not to be used in the interpretation of this Agreement.
11.9 Notices - Notice under this Agreement shall be sufficient only if
personally delivered, delivered by a major commercial rapid delivery courier
service, or mailed by certified or registered mail, return receipt requested to
a party at its addresses set forth in the signature block below or as amended by
notice pursuant to this subsection.
11.10 Entire Agreement - This Agreement supersedes all proposals, oral
or written, all negotiations, conversations, or discussions between or among the
parties relating to the subject
22
matter of this Agreement and all past dealing or industry custom.
11.11 Severability - If any provision of this Agreement is held
illegal, invalid or unenforceable by a court of competent jurisdiction, that
provision will be limited or eliminated to the minimum extent necessary so that
this Agreement shall otherwise remain in full force and effect and enforceable.
11.12 Other Uses - The development of NISIN in a probiotic is a
cooperative venture of AMBI and BIO.
SIGNATURE PAGE FOLLOWS
23
LICENSOR:
AMBI INC.
By _________/s/ Xxxxxxxx Xxxxx
Xxxxxxxx Xxxxx
Title: Senior Vice President
Address: AMBI Inc.
0 Xxxxxxxxxxxxxx Xxxx
Xxxxxxxx, XX 00000
X.X.X.
Attn: Xxxxxxxx Xxxxx, Esq.
With Copy: Xxxxx X. Xxxxxx, Esq.
Law Offices of Xxxxx X. Xxxxxx
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
LICENSEE:
BIOSYNEXUS INCORPORATED
By: _______/s/ Xxxxxx X. Xxxxxxx
Xxxxxx X. Xxxxxxx, MD
Title: President & Chief Executive Officer
Address: Biosynexus Incorporated
0000 Xxxxxxx Xxxxxx Xxxxx - Xxxxx 000
Xxxxxxxxx, XX 00000 U.S.A.
Attn: Xxxxxx X. Xxxxxxx, MD
With Copy: Xxxxxx Xxxxxx, Esq.
Winston & Xxxxxx
0000 X. Xxxxxx, XX
Xxxxxxxxxx, XX 00000
24
EXHIBIT A-1
LICENSED PRODUCTS
"Pharmaceutical Products for Human Use" which means NISIN PREPARATIONS
formulated for use in the diagnosis, cure, mitigation, treatment, or prevention
of diseases in humans.
25
EXHIBIT A-2
EXCLUDED PRODUCTS
All products that are not LICENSED PRODUCTS under this Agreement.
All products incorporating NISIN PREPARATIONS that are not LICENSED PRODUCTS
under this Agreement, including but no limited to:
NISIN PREPARATIONS in any form for use with animals;
"Skin Sanitizers" which means topical application of NISIN PREPARATIONS on human
skin to cleanse the skin, and not as a prescription or OTC drug for a specific
indication.
"Environmental Sanitizers" which means application of NISIN PREPARATIONS on hard
surfaces, and not for application on, in, or with food or for food preservation.
Food Additives for food preservation;
Food Preservatives;
Food Preservation Methods;
NISIN PREPARATIONS in combination with lysostaphin, unless lysostaphin is
licensed to BIO.
NISIN PREPARATIONS for treating diseases of the colon and for treating
hospital-acquired infections in the following countries: Japan; North Korea;
South Korea; and all other countries in Asia (excluding Israel and Russia as of
March 18, 1996);
NISIN PREPARATIONS for use with probiotics; and
NISIN PREPARATIONS for incorporation into EXCLUDED PRODUCTS.
26
EXHIBIT B1
A&B PROPRIETARY INFORMATION
Number Description
1 Analysis of NISIN PREPARATIONS by agar plate diffusion assay
2 Yield improvement by subculture in presence of NISIN
PREPARATIONS
3 Skim milk based media
4 Skim milk/whey powder based media (AM2)
5 Whey powder media (AM4)
6 Yeast extract/lactose media
7 Use of soya and cotton seed meal in nisin production media
8 Use of proteases for hydrolyses of casein and whey protein
9 Stimulatory effect of divalent cations
10 Optimum fermentation temperatures
11 Optimum fermentation pH
12 Fermentation production kinetics
13 Reagents for control of fermentation pH (sodium hydroxide,
calcium hydroxide, and ammonium hydroxide)
14 Reagents for control of fermentation pH (calcium carbonate)
15 Effect of endogenous NISIN on yield
27
16 Extraction of nisin from whole cells by use of inorganic
acids
17 Extraction of NISIN PREPARATIONS from whole culture by direct
adsorption on ion exchange/hydrophobic adsorbents
18 Purification of NISIN PREPARATIONS by adsorption on
hydrophobic interaction chromatography (HIC) media
19 Purification of NISIN PREPARATIONS by precipitation with
organic solvents
20 Use of freeze drying in production of NISIN PREPARATIONS
21 Use of spray drying in production of NISIN PREPARATIONS
22 Bulk stability of NISIN PREPARATIONS
23 Chemical and spectroscopic analysis of NISIN PREPARATIONS
24 Microbiological activity of NISIN PREPARATIONS on food
spoilage organisms
25 Microbiological activity of NISIN PREPARATIONS on common
organisms
26 Nisin GN Production Process (XX.0.XXXX 5) - see attached
Process Outline
28
EXHIBIT B2
AMBI PROPRIETARY INFORMATION
Number Description
1 Analysis of NISIN PREPARATIONS by HPLC (C8 method)
2 Analysis of NISIN PREPARATIONS by HPLC (C18 method)
3 Analysis of NISIN PREPARATIONS by Resazurin based microtitre
plate assay
4 Analysis of NISIN PREPARATIONS by capillary electrophoresis
5 Synthesis, purification, and characterization of NISIN
PREPARATIONS
6 Analysis of NISIN PREPARATIONS by agar microplate diffusion
7 Ion-exchange HPLC
8 SDS-PAGE
9 Validation of strains by pulsed-field gel electrophoresis
10 Analysis of strains by DNA sequencing
11 Strains expressing nisin variants
12 Yield improvement by recombinant mechanisms
13 Genetic analysis of immunity and production
14 Use of cysteine/methionine as stabilising agent
15 Recovery of NISIN PREPARATIONS from clarified extracts by
precipitation with sodium chloride/ammonium sulfate
16 Recovery of NISIN PREPARATIONS from washed whole cells
17 Purification of NISIN PREPARATIONS by adsorption on ion
exchange media
18 Purification of NISIN PREPARATIONS by reverse phase
chromatography
19 Solution stability of NISIN PREPARATIONS
20 Solubility of NISIN PREPARATIONS
29
21 Detection of degradation (LC/MS) of NISIN PREPARATIONS
22 Microbiological activity of NISIN PREPARATIONS on pathogenic
organisms
23 Recovery and purification of NISIN at production scale using
a simplified salt precipitation process
30
PATENTS
Exhibit C
Description
U.S. Patent No. 4,980,163 - Novel Bacteriocin Compositions For Use As Enhanced
Broad Range Bactericides And Methods Of Preventing And Treating Microbial
Infection
U.S. Patent No. 5,135,910 - Nisin Compositions For Use As Enhanced, Broad Range
Bactericides
U.S. Patent No. 5,217,950 - Nisin Compositions For Use As Enhanced, Broad Range
Bactericides
U.S. Patent No. 5,218,101 - Leader Sequence Inducing a Post-Translational
Modification of Polypeptides in Bacteria and Gene Therfor
U.S. Patent No. 5,260,271 - Nisin Compositions For Use As Enhanced, Broad Range
Bactericides
U. S. Patent No. 5,304,540 - Pharmaceutical Bacteriocin Compositions And Methods
For Using The Same
U. S. Patent No. 5,334,582 - Pharmaceutical Bacteriocin Compositions And Methods
For Using The Same
U. S. Patent No. 5,559,096 - Pharmaceutical Compositions Against Gastric
Disorders
U.S. Patent No. 5,691,301 - Nisin Compositions For Use As Enhanced, Broad Range
Bactericides
U. S. Patent No. 5,763,395 - Stabilized Bacteriocin Compositions
U.S. Patent No. 5,753,614 - Nisin Compositions For Use As Enhanced, Broad Range
Bactericides
U.S. Patent No. 5,762,948. - "Moist Bacteriocin Disinfective Wipes and Method of
Using the Same
U.S. Patent No. 5,804,549 - Compositions With Activity Against Helicobacter
31
U.S. Patent No. 5,833,958 - Dentifrice Compositions
U.S. Patent No. 5,861,275 - Lantibiotic Mutants And Chimeras Of Enhanced
Stability And Activity, Leader Sequences Therefor, Genes Encoding The Same, And
Methods Of Producing And Using The Same
U.S. Patent No. 5,866,539 - Method For The Control Of Antibiotic-Resistant Gram
Positive Bacteria And Treatment Of Infection
U.S. Patent No. 5,958,873 - Oral Formulation For Treatment Of Bacteria-Induced
Diseases Of The Colon
U.S. Patent No. 5,885,811 - Leader Sequences Inducing A Post-Translational
Modification Of Polypeptides In Bacteria Gene Therefor And Subtilin Variant Of
Enhanced Stability And Activity
U.S. Patent No. 5,910,479 - Method For The Treatment Of Streptococcus Pneumoniae
Infection
U.S. Patent No. 5,985,823 - Method For The Treatment Of Diarrheal Disease And
For Eliminating Particular Bacterial Populations From The Colon
Foreign equivalents of the above-identified United States Patents
32
