EXHIBIT 10.19
Platinate HPMA Copolymer Royalty Agreement
between
The London School of Pharmacy, University of London
and
Access Pharmaceuticals, Inc.
dated November 19, 1996
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PLATINATE HPMA COPOLYMER ROYALTY AGREEMENT
Platinate HPMA Copolymer Royalty Agreement (hereinafter "Agreement"),
effective November 19, 1996 ("Effective Date") is by and between Access
Pharmaceuticals, Inc a Delaware corporation having its principal place of
business at 0000 Xxxxx Xxxxxxxx Xxxxxxx, X xxxx 000, Xxxxxx, XX 00000-0000
(hereinafter "Access") and The School of Pharmacy, University of London
having its principal place of business at 00/00 Xxxxxxxxx Xxxxxx, Xxxxxx,
XX0X 0XX, Xxxxxxx (hereinafter "University")
PREAMBLE
WHEREAS UNIVERSITY and ACCESS have invented the Cisplatin HPMA
Copolymer product and will be joint owners of the proprietary ACCESS and
UNIVERSITY Patents (as hereinafter defined) and Know-How (as hereinafter
defined):
WHEREAS, ACCESS wishes to obtain exclusive rights and options for the
manufacture and sale of the Products in the Licensed Territory (as hereinafter
defined), and UNIVERSITY is willing to grant such rights and options under
the ACCESS and UNIVERSITY Patents and Know-How;
NOW, THEREFORE, in consideration of the foregoing premises and of the
mutual covenants of the parties hereinafter contained, the parties hereto agree
as follows:
ARTICLE 1. DEFINITIONS.
1.01 The term "ACCESS and UNIVERSITY Patents" shall mean:
a) patents held jointly by ACCESS and UNIVERSITY and patent
applications applied for by ACCESS and UNIVERSITY which either broadly
or specifically cover the Product defined in
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section 1.05 below, as listed in Schedule A attached hereto.
b) any patent issuing therefrom or any reissue or extension of such
patents as long as it covers the Products, and
c) any subsequently filed ACCESS patent application or patent covering
any invention resulting from the development of Products.
d) the right to any sole invention at the UNIVERSITY for HPMA
Cisplatin or platinum analogues.
1.02 The term "Affiliate" shall mean:
a) any corporation, firm, partnership or other entity which directly or
indirectly owns, is owned by or is under common ownership with a party, to
the extent of at least fifty percent (50%) of the equity (or such lesser
percentage which is the maximum allowed to be owned of a foreign
corporation in a particular jurisdiction) having the power to vote on or direct
the affairs of the entity, and
b) any person, firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with a party.
1.03 The term "Know-How" shall mean:
all proprietary, scientific and/or technical trade secret information
pertaining to the Products now and during the term of this Agreement,
including without limitation Know-How, pharmacological, preclinical, chemical,
biochemical, toxicological, pharmacokinetics, drawings, specifications, methods,
formulation, processes, formula of manufacture, treatment of materials,
improvement, invention and development with respect to the Products.
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1.04 The term "Net Sales" shall mean:
the gross proceeds from sales of the Products by ACCESS, its Affiliates and
any sublicensees to unaffiliated third parties, expressed in United States
Dollars less:
a) allowances for returns, chargebacks and product discounts actually
given to customers;
b) value added tax, other similar taxes or government assessments
collected on such sales;
c) rebates under the medical prescription drug rebate and improved access
to medicines requirements of the Omnibus Budget Reconciliation Act of 1990
and comparable US Federal and State requirements.
d) outbound prepaid transportation, packing and shipping actually paid by
seller if invoiced to customer.
1.05 The term "Products" shall mean:
soluble synthetic HPMA polymer conjugate of Cisplatin and/or other
platinum analogues developed pursuant to the terms of the Agreement
between the Parties dated November 19, 1996 ("Agreement") and utilizing the
ACCESS and UNIVERSITY Patent and Know-How.
1.06 The term "Licensed Territory" shall mean:
Worldwide.
1.07 The term "Major Countries" shall mean:
all countries listed in Schedule B
1.08 The term "NDA" shall mean:
a New Drug Application to be filed with the Food and Drug
Administration (FDA) of the United States or any corresponding authority
thereof or health registration application to be filed with governmental
authorities of each country in the Licensed Territory, for seeking
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governmental approvals to manufacture and/or market the Products in such
country.
1.09 The term "Effective Date" shall mean:
the date upon which this Agreement is executed by both parties.
1.10 The term "Regulatory Market Exclusivity" shall mean:
protection of the innovator's data for a defined period which prevents
generics from entering the market.
1.11 The term "Market Exclusive Position" shall mean:
no generic competitor to the Products.
1.12 The term "Right of First Refusal" shall mean:
The procedures set forth in Article 7 of this Agreement.
ARTICLE 2. GRANT OF LICENSE.
2.01 Grant of License:
UNIVERSITY hereby grants to ACCESS an exclusive right, with the
right to sublicense, under the ACCESS and UNIVERSITY Patents and
Know-How to develop, modify, have made, have used and have sold the
Products in the Licensed Territory.
ARTICLE 3. TERM OF THE AGREEMENT
3.01 This Agreement shall commence upon the Effective Date and shall
expire in each country of the Licensed Territory upon expiration of the
last-to-expire ACCESS and UNIVERSITY Patents in such country of the
Licensed Territory, as may be extended by the laws of such country in terms
of Regulatory Market Exclusivity for example, Waxman Hatch ruling and
European Community regulatory exclusivity) or if later, until the Market
Exclusive Position of the Products
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ends through a generic entrant either into the US market or a major European
market. Thereafter, ACCESS will be sole owner of the Products and royalty
payments to UNIVERSITY will cease.
ARTICLE 4. OBLIGATION OF UNIVERSITY
4.01 UNIVERSITY will promptly upon effectiveness of this agreement
provide ACCESS with all the Know-How possessed by UNIVERSITY which
is useful and necessary for ACCESS to perform the activities described in
Article 5.
ARTICLE 5. OBLIGATIONS OF ACCESS
5.01 ACCESS shall use commercially reasonable efforts to conduct its
designated development activities for the Products on a timely bases and will
provide UNIVERSITY with a copy of its development guidelines and plan
within 90 days of the Effective Date. Upon completion of each phase of
development of the Products, ACCESS and its sublicensees shall promptly
deliver the Product(s) data and results to UNIVERSITY. If ACCESS and/or
a partner has been unable to enter into Phase 1 human trials and file for
Regulatory Approval in the United States and two major European Countries
for the Products by the milestone dates specified in Schedule C hereto, then,
unless failure is due to UNIVERSITY not providing necessary data on a timely
basis, UNIVERSITY shall have the unilateral right either (a) to extend the
time for entry into Phase 1 human trials and/or filing for Regulatory Approval
or (b), after consultation with ACCESS, the rights to the Products shall revert
back to UNIVERSITY.
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ARTICLE 6. EXCHANGE OF INFORMATION AND
CONFIDENTIALITY.
6.01 Exchange of Information
UNIVERSITY shall promptly disclose to and make available to
ACCESS all Know-How possessed by UNIVERSITY and other information
related to the Products which is requested by ACCESS to conduct formulation,
preclinical and clinical studies. Both Parties agree to exchange data and
information with regard to the Products during the term of this Agreement.
Each of the Parties will limit disclosure of all exchanged information to only
those of its officers, employees and consultants who need to carry out the
requirements of this Agreement and only after each respective Party shall have
caused such officers and employees to be bound by the confidentiality
obligations set forth in this Agreement.
6.02 Confidentiality
Except where specifically requested in writing and approved by the
other Party, each Party agrees to keep in strict confidence and not to disclose
to any person without the prior written consent of the other party any data and
information obtained from the other Party under this Agreement, including
UNIVERSITY and ACCESS Patent information, provided, however, that the
provisions of this section shall not apply to the data and information which;
a) are already known to the receiving Party at the time of the disclosure.
b) becomes known to the receiving Party through a third party who has
the right to disclose the data and
information to the receiving Party, or
c) becomes known to the public other than as a result of any disclosure
or other act by the receiving
Party.
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d) are required to be furnished to regulatory authorities.
The obligation of the receiving Party under this Section shall survive
termination of this Agreement for a period of five (5) years.
ARTICLE 7. RIGHT OF FIRST REFUSAL
7.01 Grant of Right:
UNIVERSITY will advise ACCESS in writing prior to commencement
of any research work of its intent to investigate a new product opportunity in
the field of copolymer platinate technology ("New Copolymer Platinate
Technology"). Subject to the provisions of this Article, UNIVERSITY hereby
grants to ACCESS a Right of First Refusal, to license or obtain an option to
license all such New Copolymer Platinate Technology and respective patents.
7.02 Notice of New Copolymer Platinate Technology:
UNIVERSITY shall notify ACCESS in writing of each New Copolymer
Platinate Technology product opportunity, and if ACCESS within thirty (30)
days of receiving the notice provides UNIVERSITY with written notice of its
possible interest in exercising its Right of First Refusal, UNIVERSITY shall
provide ACCESS within thirty (30) days all available data to assist ACCESS
in deciding whether it wishes to exercise such Right of First Refusal.
Notwithstanding anything to the contrary in this Article 7, ACCESS shall not
be required to give any notice of interest within the first twelve (12) months
following the date of this Agreement.
7.03 License Agreement or Option Agreement:
Upon UNIVERSITY receipt of notice from ACCESS of its interest to
license or obtain an option to license, the Parties shall negotiate in good
faith the terms of the applicable license
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(on terms comparable to those outlined in Article 15 of the Agreement). If the
Parties are unable to agree on all terms of a license or option to license
within one hundred twenty (120) days after ACCESS's receipt of all available
data from UNIVERSITY, UNIVERSITY shall have the right to grant a license or
option to license for the New Copolymer Platinate Technology product to a
third party. Notwithstanding anything to the contrary in this Article 7,
UNIVERSITY shall not grant a license or option to license to any party on
terms and conditions not significantly better than those offered by ACCESS.
7.04 Expiration of Right:
The Right of First Refusal shall expire at the termination date of this
Agreement, provided, however, that Section 13.03 (Effects of Termination)
shall remain in effect.
ARTICLE 8. DEVELOPMENT AND GOVERNMENT APPROVAL
8.01 ACCESS shall use commercially reasonable efforts to obtain NDA
approvals and other government approvals in the major countries as listed in
Schedule B in the Licensed Territory. ACCESS and its sublicensees shall hold
and maintain such approvals at its cost and expenses during the term of this
Agreement and shall not transfer, assign or dispose of such approvals without
the prior written consent of UNIVERSITY.
8.02 ACCESS and its sublicensees shall conduct all
the studies for the development of the Products necessary for obtaining NDA
approval in any and all countries listed in Schedule B.
8.03 The cost for the development of the Products shall be borne by
ACCESS and its sublicensees.
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8.04 ACCESS shall promptly notify UNIVERSITY from time to time of the
information on the date of filing of said NDA, the date of obtaining NDA
approval of the Products, the date of obtaining the price listing in the price
list of the national
health insurance scheme for the Products in each country of the
Licensed Territory, if any, and the date of launch of the Products in each
country of the Licensed Territory. ACCESS agrees to inform UNIVERSITY
at least every six months of the progress of the development and registration
procedures for the Products in each country as listed in Schedule B of the
Licensed Territory.
8.05 Upon completion of the NDA, if the NDA is not filed in any particular
country listed in Schedule B in the Licensed Territory, UNIVERSITY may as
its sole remedy for such failure by ACCESS, terminate the Agreement with
respect to such particular country of the Licensed Territory, provided that
UNIVERSITY shall not exercise its right under this Section 8.05 in the event
ACCESS or its sublicensees clearly demonstrates to UNIVERSITY that it is
exercising due diligence in pursuing such NDA.
8.06 If ACCESS fails to develop the Products in the Licensed Territory
solely for scientific reasons, ACCESS shall promptly notify and explain to
UNIVERSITY the situation. If UNIVERSITY regards such ACCESS failure
as reasonable, each party may terminate this Agreement as its sole remedy.
ARTICLE 9. REPRESENTATIONS AND WARRANTIES.
9.01 Due Authorities.
ACCESS and UNIVERSITY each represent to the other that they have
full power and authority to enter into this Agreement and to carry out the
transactions contemplated hereby.
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9.02 UNIVERSITY Intellectual Property.
a) UNIVERSITY represents to ACCESS that to the best of its knowledge
its Know-How or that the license and use by ACCESS of Know-How will not
infringe any third-party ACCESS and UNIVERSITY patents.
b) UNIVERSITY represents that it is the sole and exclusive owner of the
Know-How and has not assigned, transferred or licensed or otherwise
encumbered the Know-How or ACCESS and UNIVERSITY Patents.
c) UNIVERSITY represents that it is not aware of any additional rights
or licenses necessary for ACCESS to exercise the exclusive license granted
hereunder.
ARTICLE 10. EXCHANGE OF KNOW-HOW
10.1 Promptly after the execution of this Agreement and from time to time
thereafter during the term of this Agreement, UNIVERSITY shall disclose to
ACCESS all relevant Know-How relating to the Products which UNIVERSITY
has developed or acquired or may hereafter develop or acquire during the
term of this Agreement and which is necessary or helpful for ACCESS or its
sublicensees:
i) to obtain the NDA approvals or other governmental approvals to
market the Products in the Licensed Territory,
ii) to manufacture the Products, and
iii) to generally fulfill the purpose of this Agreement.
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10.2 During the term of this Agreement, ACCESS may use any Know-How
disclosed by UNIVERSITY to ACCESS hereunder for the purpose of this
Agreement without any additional payment.
10.3 ACCESS agrees to keep UNIVERSITY informed every six months
during the term of the Agreement, of all the Know-How relating to the
Products which ACCESS or its sublicensees, if any, have heretofore developed
or acquired or may hereafter develop or acquire during the term of this
Agreement.
ARTICLE 11. PATENTS AND PATENT INFRINGEMENT.
11.01 Patent Applications
Except as otherwise agreed by the Parties with respect to specific ACCESS and
UNIVERSITY Patents, so long as this Agreement is in effect, ACCESS shall
be responsible for the filing and prosecution of all patent applications
relating to the Products and maintaining the ACCESS and UNIVERSITY Patents
in the United States of America, Europe and Japan. UNIVERSITY agrees to
reasonably cooperate with ACCESS in the application and prosecution of the
patents/patent applications relating to the Products. In the event ACCESS
shall elect to abandon or not to maintain any ACCESS and UNIVERSITY
Patents, ACCESS shall so advise UNIVERSITY in writing and UNIVERSITY
shall have the right at its sole cost to maintain such ACCESS and
UNIVERSITY Patents in part or in full after written notice to ACCESS.
Although ACCESS and UNIVERSITY
will be joint owners of the proprietary patents, the issued patents will be
assigned to ACCESS.
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11.02 Responsibility for Cost
Subject to section 11.01, ACCESS agrees to fund present and subsequent
patent costs associated with the List of ACCESS and UNIVERSITY Patents
attached as Schedule A in the countries of the United States, Europe and
Japan. Should UNIVERSITY request the filing, prosecution and maintenance
of patents relating to the Products and Technology in additional countries
within the Territory, ACCESS will use commercially reasonable efforts to
extend the patent coverage at UNIVERSITY's direction and cost. Specific
patent applications requested or initiated related to Products developed under
this Agreement will be subject to this provision.
11.03 Notice of Infringement
Each Party agrees to give the other immediate written notice of any
infringement of any ACCESS and UNIVERSITY Patents by third Parties as
may come to its knowledge. In the event of any infringement or in the event
of any application being made for revocation of any patent pertaining to the
ACCESS and UNIVERSITY Patents, ACCESS may at its sole discretion take
all actions or proceedings that it shall deem necessary, at its own cost, to
restrain the infringement or defend the revocation, as the case may be, and
shall have the reasonable cooperation of UNIVERSITY in that endeavor and
ACCESS will receive all recoveries. If ACCESS decides that it does not want
to take any such action or start any such proceedings within (60) days after
becoming aware of such threat, the Parties shall consult in good faith on how
to deal with the situation, with the intention of taking all reasonable steps to
protect the ACCESS and UNIVERSITY Patents. ACCESS shall be
responsible for paying all expenses and costs associated with the infringement
action and will be entitled to all recoveries.
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11.04 Infringement by ACCESS and UNIVERSITY Patents.
If, in exercising its rights under this Agreement, ACCESS is accused of
infringing a product's patent owned by a third party with regard to the
Products, and ACCESS does not choose to dispute such claim, ACCESS and
UNIVERSITY shall use their best efforts to obtain rights for ACCESS and
UNIVERSITY under the third-party patent. If, in obtaining such rights from
such third party, ACCESS or UNIVERSITY (after consultation with ACCESS)
is required to make any payment, such payment shall be made by ACCESS.
ARTICLE 12. TRADEMARKS AND TRADE NAMES.
12.01 Trademarks.
ACCESS and its sublicensees shall choose and own all trademarks and trade
names which are specific to the individual Products in the Territory.
12.02 Application and Maintenance.
Products specific trademarks will be applied and maintained by ACCESS in
the Territory and all the cost associated therewith shall be borne by ACCESS.
ARTICLE 13.TERMINATION
13.01 Term
This Agreement shall be in effect for the period of duration set forth
in Section 3.01 hereof.
13.02 Termination.
a) Either party may terminate this Agreement by giving written notice of
termination to the other party at any time during the term of this Agreement;
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i) in the event that the other commits any material breach of its
obligations hereunder and fails to remedy such breach within ninety (90) days
after submission of writtennotice requesting the correction of the breach; or
ii) upon the filing or institution of bankruptcy, reorganization or
receivership proceedings by the other party or upon the failure by the other
party for more than ninety (90) days to take steps to oppose the initiation of
such actions against it.
b) ACCESS shall promptly advise UNIVERSITY if ACCESS decides not
to commercialize the Products in any major country listed in Schedule B, then
such particular country shall thereafter be automatically excluded from the
Licensed Territory hereof.
c) Exercise by either party hereto of a termination right provided for
under this Agreement shall not give rise to the payment of damages or any
other form of compensation or relief to the other party with respect hereto.
d) Subject to Section 13.02 (c), termination of this Agreement shall not
preclude either party from claiming any other damages, compensation or relief
that it may be entitled to under this Agreement or by law or in equity upon
such termination.
13.03 Effects of Termination.
If this Agreement is terminated as set forth in Section 13.02, ACCESS
will:
a) renounce all rights to the terminated Products under development,
including all ACCESS and UNIVERSITY Patents, Know-How and other
information provided by and under this Agreement;
b) ACCESS and UNIVERSITY will return all Confidential Information
of the other party.
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ARTICLE 14 ARBITRATION.
14.01 Agreement to Arbitrate.
The Parties will endeavor to settle amicably any dispute which may
arise out of this Agreement. Failing of such settlement, any dispute shall be
finally settled by arbitration, in accordance with the rules then in effect of
the International Chamber of Commerce. The arbitration will be held in Dallas
when it is initiated by UNIVERSITY and in London when it is initiated by
ACCESS. The dispute or difference shall be referred to a single arbitrator, if
the Parties agree upon one, or otherwise three (3) arbitrators, one to be
appointed by each party and the third to be appointed by the first two (2)
arbitrators selected by the Parties. If a Party shall refuse or neglect to
appoint an arbitrator within thirty (30) days after the other Party shall
have served a written notice of such other Party's choice and requesting that
the first-mentioned Party make its choice, then the arbitrator first appointed
shall, at the request of the Party appointing him, proceed to hear and
determine the matters in difference as if he were a single arbitrator appointed
by both parties.
14.02 Arbitration Decision.
The arbitrators shall base their decision in accordance with and based
upon all the provisions of this Agreement and any other agreements
referenced herein, to the extent such other agreements are not superseded by
this Agreement or subsequent agreements between the Parties. In making their
decision, the arbitrators shall apply the substantive law of the State of
Delaware and the United States of America, excluding the United Nations
Convention on the International Sale of Goods. The decision of a majority of
the arbitrators shall be final and binding upon each Party, and judgment upon
the award may be entered in any court of competent jurisdiction.
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14.03 Pre-Decision Settlement.
Before rendering their final decision, the arbitrators will first act
as friendly, disinterested parties for the purpose of helping the Parties
attempt to reach a compromise settlement on the points in dispute.
14.04 Payment of Costs.
The cost of arbitration will be in the discretion of the arbitrators.
Each Party shall pay its own costs associated with the arbitrators, plus one-
half of the costs of the arbitration itself (including but not limited to
arbitrators fees).
ARTICLE 15. TERMS AND CONDITIONS OF ROYALTY
AGREEMENT
a) License Agreement
UNIVERSITY grants ACCESS an exclusive license to make, use and
sell the Products in the Territory.
b) Royalty
ACCESS shall pay to UNIVERSITY a royalty of one percent (1%) of
Net Sales in each country of the Territory where there is patent protection
and/or a Market Exclusive Position.
c) Termination of the License Agreement
In the event of termination of the exclusive right to manufacture and
sell the Products in the Licensed Territory by ACCESS, ACCESS will transfer
the health registrations and the Trademarks for the Products to UNIVERSITY
at ACCESS's expense.
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d) Sub-licensing Rights & Sub-Licensing Milestone Payments
ACCESS is granted rights to sub-license the Products without
UNIVERSITY approval. UNIVERSITY will receive the following
sub-licensing milestone payments:
i) entry into Phase 1 human trials, UNIVERSITY
will receive 5% of all sub-licensing milestone payments with a minimum
payment of $100,000 (one hundred thousand US dollars).
ii) executing a corporate licensing agreement, UNIVERSITY will
receive 5% of all sub-licensing milestone payments with a minimum payment
of $100, 000 ( one hundred thousand US dollars).
iii) entry into Phase 11 human trials, 5% of all sub-licensing
milestone payments with a minimum payment of $100,000 (one hundred thousand
US dollars).
iv) entry into Phase 111 human trials, 5% of all sub-licensing
milestone payments with a minimum payment of $100,000 (one hundred thousand
US dollars).
v) NDA approval, 5% of all sub-licensing milestone payments with a
minimum of $100,000 (one hundred thousand US dollars).
e) Development
ACCESS will undertake at its own cost, the timely performance of all
formulation/clinical development work, regulatory actions and filings necessary
for government approval of the Products in each country of the Territory as
listed in Schedule B.
f) Regulatory Approval Plan
On completing Phase 1 human trials, ACCESS will provide
UNIVERSITY with a regulatory approval plan for the Products in major
countries listed in Schedule B.
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g) Product Rights
In those countries listed in Schedule B where ACCESS declines or fails
to pursue Products registrations and marketing, the commercial rights to the
Products shall revert to UNIVERSITY. ACCESS will provide UNIVERSITY
with the available regulatory dossiers necessary to pursue registration of such
Products in these markets, free of charge.
h) Marketing Obligation
Following the approval of the Product License applications in the
Territory, ACCESS will use reasonable commercial efforts, subject to
compliance with all applicable laws and regulations, to promote and market
the Products.
i) Intellectual Property and Know-How
Any new or improved technology, or Know-How (and any subsequently
filed patent applications or patents covering any such invention or
improvement) resulting from the efforts of ACCESS shall be the exclusive
property of ACCESS. Other inventions or improvements resulting from the
joint efforts of the Parties shall be the co-exclusive property of ACCESS and
UNIVERSITY and shall be subject to royalty payments outlined in Section 15
(b).
j) Publications.
Any publications relating to the Products, shall require the mutual
consent of UNIVERSITY and ACCESS which consent shall not be
unreasonably withheld. In any event, permission to publish will be granted
within 6 (six) months after notice and opportunity to pursue patent protection.
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k) Press Releases
Neither Party shall issue any press release in whatever form, or make
public, in whatever form, information regarding the Agreement and any
definitive Cisplatin Polymer Royalty Agreement without prior written approval
of the other party, except as required by applicable law and regulations.
ARTICLE 16 MISCELLANEOUS
16.01 Governing Law.
This Agreement shall be construed and enforced in accordance with the
laws of the State of Delaware, United States of America.
16.02 Severability.
In the event any portion of this Agreement shall be held illegal, void
or ineffective, or in conflict with any applicable statute or rule of law, such
portion shall be deemed modified to the extent necessary to avoid such result
and the remaining portions shall remain in full force and effect. If compliance
with the foregoing sentence results in a material alteration of this Agreement,
the Parties agree to renegotiate in good faith the terms and conditions of the
altered portion in order to approximate as nearly as possible the intent of the
Parties with respect to any relevant portion.
16.03 Waiver
The failure of ACCESS and UNIVERSITY at any time to exercise or
enforce any right granted in this Agreement or obligation arising hereunder
shall not be deemed to be a waiver of such right or obligation or operate to
bar the exercise or enforcement thereof at any time thereafter.
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16.04 Force Majeure
If either Party shall be delayed, hindered, interrupted in or prevented
from the performance of any obligation hereunder by reason of force majeure
(hereinafter referred to as "Force Majeure"), including earthquake, flood or
other act of God, fire, war (declared or undeclared), public disaster, riots,
strike or labor differences, governmental enactment, rule or regulation or any
other cause beyond such Party's reasonable control, such Party shall not be
liable to the other therefore; and the time for performance of such obligation
shall be extended for a period equal to the duration of the contingency which
occasioned the delay, interruption or prevention. The Party invoking such
Force Majeure rights under this Section must notify the other Party by
registered letter within a period of fifteen (15) days, from the first and the
last day of the Force Majeure unless the Force Majeure renders such
notification impossible in which case notification will be made as soon as
possible. If the delay resulting from the Force Majeure exceeds six (6) months,
the Parties commit to consult together in good faith to find an appropriate
solution.
16.05 Successors and Assigns.
This Agreement and any licenses granted pursuant to this Agreement
shall be binding upon and shall inure to the benefit of, successors and assigns
of each of the Parties, but neither this Agreement nor any of the rights,
interests or obligations hereunder may be assigned by either of the Parties
hereto without the prior written consent of the other Party, which consent
shall not be unreasonably withheld; provided that the
Agreement may be assigned in the event of a transfer to an Affiliate, or in
connection with a merger, consolidation, or sale of substantially all of the
assets of the transferring Party. Notwithstanding anything to the contrary
herein, ACCESS may delegate to its Affiliates its duties and obligations
hereunder without the consent of UNIVERSITY.
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16.06 Independent Contractor
This Agreement shall not create an agency, partnership, joint venture
or employer/employee relationship between the Parties. ACCESS and
UNIVERSITY each hereby agrees not to represent itself in any of such
capabilities in any manner whatsoever. The sole relationship established by
this Agreement is that of independent contractors, and nothing hereunder shall
be construed to give either Party the power or authority to act for, represent,
bind, or commit the other Party or any of its Affiliates.
16.07 Captions.
The captions provided in this Agreement are for convenience of
reference only and shall not effect its interpretation.
16.08 The Agreement
This Agreement represents the entire agreement between the parties
relating to the subject matter hereof and supersedes all other writings and
discussions related to such subject matter.
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16.09 Notice
Any notice expressly provided for under this Agreement shall be in
writing, sent by registered or certified first class airmail, overnight express
mail or courier service, facsimile transmission or other similar electronic
means of written communication, addressed as set forth below:
If to ACCESS: ACCESS Pharmaceuticals, Inc
0000 Xxxxx Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, Xxxxx 00000
U.S.A.
Attention:President and CEO
Copy to: Xxxxxxx, Xxxx and Xxxxx LLP
000 Xxxxxxx Xxxxxx
Xxxxxx
Xxxxxxxxxxxxx, 00000-0000
If to UNIVERSITY: The School of Pharmacy
University of London
00/00 Xxxxxxxxx Xxxxxx
Xxxxxx, XX0X 0XX
Xxxxxxx
Attention:Xxxx
Facsimile transmission numbers for the Parties are as follows:
If to ACCESS USA 000-000-0000
If to UNIVERSITY England 011-44-171-278-0622
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ACCESS PHARMACEUTICALS INC THE SCHOOL OF
PHARMACY
UNIVERSITY OF LONDON
by: /s/ Xxxxx X. Xxxx by: /s/ X. X. Xxxxxx
------------------- --------------------
Title: President & CEO Title: Clerk to the Council
---------------- ---------------------
Date: 11/19/96 Date: 11/28/96
----------------- ---------------------
11/19/96
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SCHEDULE A-PATENTS/PATENT APPLICATIONS
Will be sent when filed.
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SCHEDULE B-MAJOR MARKETS
AMERICAS EUROPE ASIA PACIFIC
United States Germany Japan
Canada France Peoples Republic of China
Argentina Italy Korea
Brazil United Kingdom Australia
Mexico Spain Taiwan
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SCHEDULE C-REGULATORY MILESTONES DATES
REGULATORY MILESTONE MILESTONE DATE
Acceptance by the EORTC 2 years from EORTC Approval
of Cisplatin Polymer as a
drug candidateand entry into
Phase 1 human trials
NDA filing for Cisplatin 6 years from completion of Polymer with the
FDA or Phase 1 human trials
European MEA
If the delay in filing the Cisplatin Polymer is due to UNIVERSITY's failure
to provide data on the dates agreed by the parties, the milestone dates
specified above shall be extended on a day to day basis equal to
UNIVERSITY's delay.
