5% AMLEXANOX PASTE LICENSING AGREEMENT
5%
AMLEXANOX PASTE
08/11/98
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TABLE
OF CONTENTS
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ARTICLE
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PAGE
NO
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1. Definitions
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1-5
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2. Grant
of License
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6
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3. Technology
& Know-how, Transfer & Research
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7-8
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4. Strakan
Development & Diligence
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8-9
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5. Patent
Rights
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10
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6. Royalties
& Milestone Payments
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11-13
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7. Manufacturing
& Strakan's Gross Margin
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14
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8. Regulatory
Responsibilities
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14-17
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9. Minimum
Sales Obligations
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18-19
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10. Confidentiality
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19-21
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11. Third
Party Infringement Claims
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22-23
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12. Patent
Enforcement & Litigation
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23-26
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13. U.S.
Export Control & Government Licenses
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26
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14. Product
Liability & Indemnification
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27-28
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15. Warranties
& Representations
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28-29
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16. Term
& Termination
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30-34
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17. Force
Majeure
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34-35
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18. Notices35-36
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37-38
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19. Dispute
Resolution
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38-39
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20. Assignment
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39-41
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21. Miscellaneous
Provisions
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41
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22. Signature
Page
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Appendix
A-Binding Letter of Intent
Appendix
B-Patents
Appendix
C-Markets
Appendix
D-Clinical Trials Insurance
Appendix
E-Block License Agreement
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08/11/98
5%
AMLEXANOX PASTE LICENSE AGREEMENT
THIS
license agreement (hereinafter "LICENSE") dated as of August 13, 1998 is
made
between Access
Pharmaceuticals, Inc. (hereinafter "ACCESS");
a
corporation duly formed and existing under the laws of the State of Delaware,
having a place of business at 0000 Xxxxxxxx Xxxxxxx, Xxxxx 000, Xxxxxx, XX
00000-0000; and Strakan Ltd. (hereinafter "STRAKAN"); a company duly formed
and
existing under the laws of England and Wales (Registered No. 3504711) whose
registered office is at 00 Xxxxx Xxxx Xxxxxx, Xxxxxx X0X 0XX, Xxxxxxx, Xxxxxx
Xxxxxxx:
08/11/98
When
used
in this LICENSE, the following terms shall have the meanings set out below,
unless the context requires otherwise. The singular shall be interpreted
as
including the plural and vice versa, unless the context clearly indicates
otherwise.
| 1.1 |
"AFFILIATE"
means :
|
| 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, or
|
| b) |
any
person, firm, partnership, corporation or other entity actually CONTROLLED
by, CONTROLLING or under common CONTROL with a
PARTY.
|
| 1.2 |
"APPROVAL"
means final approval by a REGULATORY AUTHORITY in any country where
applicable in the TERRITORY, for commercial marketing of the PRODUCT,
as
the case may be, including for example approval of final labeling
and
price reimbursement approval.
|
| 1.3 |
"BINDING
LETTER OF INTENT" means the Amlexanox Letter of Intent signed by
both
PARTIES expressing their intent for this LICENSE, effective January
7,
1998, a copy of which is provided as Appendix
A.
|
| 1.4 |
"BLOCK
LICENSE AGREEMENT" means the agreement between ACCESS and the PRODUCT
OWNER dated March 5, 1998, a redacted copy of which is provided in
Appendix E.
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| 1.5 |
"CONFIDENTIAL
INFORMATION" means any information of either PARTY regarding DRUG
SUBSTANCE, TECHNOLOGY, PATENTS, PRODUCT, financial terms of this
LICENSE,
and business development plans for the PRODUCT, but does not include
information excluded under Article 10.2.
|
| 1.6 |
"CONTROL",
"CONTROLLING" or "CONTROLLED" shall mean, in the case of a corporation,
ownership or control, directly or indirectly, of more than fifty
percent
(50%) of the shares of stock entitled to vote for the election of
directors and, in the case of an entity other than a corporation,
ownership or control, directly or indirectly, of more than 50% of
the
assets or the ability to direct the management and affairs of such
entity.
|
| 1.7 |
"DRUG
SUBSTANCE" shall mean amlexanox (2-amino-7-isopropyl-5-oxo-5H-[1]
benzopyrano-{2,3-b}- 3-carboxylic acid.
|
| 1.8 |
"EFFECTIVE
DATE" means the date first written above.
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| 1.9 |
"EUROPEAN
COMMUNITY APPROVAL" shall mean regulatory approval for the PRODUCT
in the
European Community Countries (EC) listed in Appendix C under the
Mutual
Recognition Procedure.
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| 1.10 |
"FDA"
means the United States Food and Drug Administration or any successor
US
governmental agency performing similar
functions.
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| 1.11 |
"FIELD"
shall mean the treatment of aphthous ulcers for human
use.
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| 1.12 |
"KNOW
HOW" means all factual knowledge and proprietary information pertaining
to
the DRUG SUBSTANCE and the PRODUCT and its which is of a nature held
in
the pharmaceutical industry as trade secrets or otherwise as confidential
information, including without limitation formulation, pharmacological,
preclinical, clinical, chemical, biochemical, toxicological and
pharmacokinetics information whether or not capable of precise separate
description and certain manufacturing, business, financial, formulation
and scientific research data or
information.
|
| 1.13 |
"MARKET
EXCLUSIVITY" means no other product in the market with the same DRUG
SUBSTANCE in the same concentration as the PRODUCT, either generic
or
branded.
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| 1.14 |
"NET
SALES" shall mean the gross proceeds from sales of the PRODUCT by
STRAKAN
or its AFFILIATES
and any sublicensees to unaffiliated THIRD PARTIES less:
|
| a) |
allowances
for returns, chargebacks, product discounts actually given to customers,
recalls and customary trade allowances, in each case as such are
related
to the PRODUCT, excluding settlement
discounts;
|
| b) |
any
sales tax, value added tax, goods and services tax or other similar
taxes
that may be imposed on the sale of the PRODUCT, which taxes are included
in the gross sales revenues;
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| c) |
drug
rebates mandated by government agencies in any one country of the
TERRITORY.
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| 1.15 |
"PARTY
or PARTIES" shall mean either ACCESS or STRAKAN, or collectively
ACCESS
and STRAKAN.
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| 1.16 |
"PATENT
or PATENTS" means the Patents licensed and/or patent applications
applied
for as listed in Appendix B attached hereto. Appendix B shall be
updated
from time to time, at STRAKAN's request, but not more frequently
than once
yearly, unless required to provide information to compute the payments
due
under this LICENSE.
|
| 1.17 |
"PRODUCT"
means 5% DRUG SUBSTANCE paste for human use developed pursuant to
the
terms of this LICENSE utilizing the PATENTS, TECHNOLOGY or KNOW-HOW
including: any new improvements, dosage forms, formulations or line
extensions to the PRODUCT in the FIELD including but not limited
to
Pharmacy and over the counter (OTC) strengths of DRUG SUBSTANCE in
the
FIELD.
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| 1.18 |
"PRODUCT
OWNER" means Block Drug Company, Inc of 000 Xxxxxxxxxx Xxxxxx, Xxxxxx
Xxxx, Xxx Xxxxxx 00000, XXX.
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| 1.19 |
"REGULATORY
AUTHORITY" means the agency corresponding to the FDA in each country
of
the TERRITORY.
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| 1.20 |
"TECHNOLOGY"
shall mean technology licensed to ACCESS relating to pharmaceutical
vehicles incorporating the DRUG
SUBSTANCE.
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| 1.21 |
"TERRITORY"
means United Kingdom and the Republic of
Ireland.
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| 1.22 |
"THIRD
PARTY or PARTIES" means anyone, other than STRAKAN, ACCESS, and their
AFFILIATES. Thus THIRD PARTY includes, without limitation, physicians,
hospitals, clinics, hospice facilities, patients, STRAKAN sub-licensees
and distributors.
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| 2.1 |
Grant
of Licenses
-
ACCESS hereby grants to STRAKAN, and STRAKAN hereby accepts an exclusive
license to use the ACCESS KNOW-HOW and the TECHNOLOGY to make, have
made,
use, develop, modify, market, sell and have sold PRODUCT in the TERRITORY
in the FIELD, and an exclusive sub-license under the PATENTS to make,
have
made, use, develop, modify, market, sell and have sold PRODUCT in
the
TERRITORY in the FIELD. These licenses shall be fully exclusive,
to the
exclusion of ACCESS and its AFFILIATES. The rights granted hereunder,
however, are subject to the rights granted to ACCESS by the PRODUCT
OWNER
under the BLOCK LICENSE AGREEMENT.
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| 2.2 |
Sublicensing
-
The exclusive license under Article 2.1 to STRAKAN includes the right
to
sublicense the rights to the PRODUCT in the Republic of Ireland,
including
the right to enter into distributor contracts or co-promotion agreements
in that country subject to the terms of the BLOCK LICENSING AGREEMENT,
ACCESS approval will not be unreasonably withheld. STRAKAN shall
be free
to sub-license the exclusive rights granted under Article 2.1 to
its
AFFILIATES subject to the terms of the BLOCK LICENSE AGREEMENT, ACCESS
approval not to be unreasonably withheld or delayed. If a STRAKAN
sublicensee or AFFILIATE behaves in a manner which places STRAKAN
in
breach of the terms of the LICENSE, then STRAKAN and ACCESS shall
discuss
the best approach to settle these issues using their commercially
reasonable efforts. All such sublicenses shall be in writing and
copies of
such sub-licenses will be provided to ACCESS promptly on
execution.
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| 3.1 |
TECHNOLOGY
and ACCESS KNOW-HOW Transfer
-
ACCESS shall disclose such TECHNOLOGY and the ACCESS KNOW-HOW as
it exists
and as is in the possession of ACCESS at the EFFECTIVE DATE and thereafter
as it comes into the possession of ACCESS from time to time to STRAKAN,
regarding PRODUCT in the FIELD under the provisions of this LICENSE.
All
TECHNOLOGY, ACCESS KNOW-HOW and any STRAKAN KNOW-HOW hereto disclosed
by
either PARTY to the other regarding PRODUCT (regardless of field
of use)
shall be deemed to have been disclosed pursuant to this LICENSE and
shall
be subject to the provisions of this LICENSE (including, but not
limited
to, Article 10 hereof). TECHNOLOGY transfer may be carried out by
oral
(subject to subsequent confirmation written or by electronic means).
If
STRAKAN desires that any sublicensee participate or receive PRODUCT,
STRAKAN shall be responsible for any required governmental export
license.
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| 3.2 |
Restricted
Information -Neither
PARTY shall be obligated to disclose to the other PARTY any information
that it is contractually or legally prohibited from disclosing to
the
other PARTY. In the event such restriction applies, the affected
PARTY
will notify the other PARTY, and the PARTIES will use their good
faith
efforts, including obtaining necessary consents or permits, to accomplish
disclosure of such information by consent or lawful
means.
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| 3.3 |
ACCESS'
assistance to STRAKAN-
After submission of an application for APPROVAL in a country of the
TERRITORY or in relation to an application for EUROPEAN COMMUNITY
APPROVAL, STRAKAN may ask for expertise to answer questions from
the
REGULATORY AUTHORITY or any other regulatory authority in relation
to an
application for EUROPEAN COMMUNITY APPROVAL. If reasonably possible,
ACCESS shall procure the necessary information, assist STRAKAN in
contacting and meeting with the PRODUCT OWNER and/or DRUG SUBSTANCE
manufacturer and shall provide such reasonable assistance, at no
cost to
STRAKAN. In the event that such assistance from ACCESS to answer
requests
will require unexpected amounts of time, resources and effort by
ACCESS
over and above that anticipated to obtain APPROVAL and for EUROPEAN
COMMUNITY APPROVAL, then the PARTIES shall agree upon the cost to
be paid
by STRAKAN to ACCESS to expend such time, resources and efforts prior
to
the commencement thereof.
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3.4
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Future
Research
-Upon the EFFECTIVE DATE, STRAKAN agrees that any research conducted
by
ACCESS on PRODUCT at STRAKAN's written request shall be paid by
STRAKAN.
Any resulting patents shall be treated in accord with Article
5.1.
|
| 4.1 |
Development
and Marketing Efforts for PRODUCT
-
STRAKAN will subject to Articles 3.1 and 3.2, undertake at its own
cost,
the timely performance of all necessary stability work, regulatory
actions
and filings necessary to obtain APPROVAL and EUROPEAN COMMUNITY
APPROVAL.
|
STRAKAN
will promptly notify ACCESS of the filings of all applications for APPROVAL
and
EUROPEAN COMMUNITY APPROVAL under Article 4.1.
| 4.2 |
Regulatory
Progress Reports
-
STRAKAN will provide ACCESS with quarterly progress reports (reports
to be
verbal with two written biannual reports per year) of its registration
activity, including submission(s) and grant(s) for APPROVAL and EUROPEAN
COMMUNITY APPROVAL.
|
| 4.3 |
Clinical
Studies-STRAKAN
shall carry out such further studies of the PRODUCT as it deems necessary
or advisable to commercialize the PRODUCT in the TERRITORY subject
to
approval of ACCESS and the PRODUCT OWNER. ACCESS approval not to
be
unreasonably withheld or delayed. STRAKAN and ACCESS shall use good
faith
efforts to cooperate with respect to any issues that concern the
commercialization of the PRODUCT under this
LICENSE.
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4.4
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STRAKAN's
Responsibility-STRAKAN,
after discussion with ACCESS, shall be responsible for the planning,
design and execution of the regulatory strategy and commercialization
of
the PRODUCT for the TERRITORY after the EFFECTIVE DATE.
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| 4.5 |
Marketing
Obligations
-
Following the grant of APPROVAL for the PRODUCT in a country of the
TERRITORY, STRAKAN and its sublicensees will launch the PRODUCT in
such
country within six (6) months. STRAKAN and its sub-licensees shall
use
reasonable commercial efforts to promote the commercialization and
sales
of PRODUCT in such country, subject to compliance with all applicable
laws
and regulations to promote and market the PRODUCT. STRAKAN and its
sublicensees shall maintain a competent marketing and sales organization
including permitted sub-distributors for this
purpose.
|
| 4.6 |
STRAKAN's
Trademarks-STRAKAN
shall choose and own all trademarks and trade names, which are specific
to
the PRODUCT in the TERRITORY during the term of this LICENSE and
after its
expiration or termination STRAKAN shall apply for and maintain such
trademarks at its own cost.
|
| 4.7 |
Restriction
of Sales
-
STRAKAN will not, for the duration of this exclusive period of the
|
LICENSE,
manufacture, market, sell or distribute a competing product to the PRODUCT
in
the TERRITORY.
| 5.1 |
Filing,
Prosecution and Maintenance of PATENTS
-
ACCESS has the responsibility to see that PATENTS are filed and prosecuted
for the PRODUCT and for maintaining the PATENTS in the TERRITORY.
STRAKAN
agrees to reasonably cooperate with ACCESS and the PRODUCT OWNER
in the
prosecution of the PATENT applications relating to the PRODUCT. ACCESS
shall use good faith efforts to ensure that PATENTS are prosecuted,
issued
and maintained in the TERRITORY. In the event ACCESS elects not to
file
and prosecute or to abandon or not to maintain any PATENT, ACCESS
shall so
advise STRAKAN in writing and STRAKAN shall have the right at its
sole
cost to maintain such PATENT in part or in full by giving a pre-written
notice to ACCESS.
|
Except
as
provided in Section 5.1, ACCESS confirms that present and subsequent PATENT
costs associated with the PATENTS in the TERRITORY have been and will be
funded.
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 or the PRODUCT OWNER, or from the joint efforts
of
ACCESS and STRAKAN, shall be the exclusive property of ACCESS and PRODUCT
OWNER
to the extent permitted by applicable law.
| 5.2 |
PATENT
Notices
-
ACCESS shall advise STRAKAN of the grant, extension, restoration,
nullification, revocation, or invalidation of any of the PATENTS
at the
annual update of Appendix B.
|
| 6.1 |
Royalties-
STRAKAN
will
pay ACCESS
a
royalty of Ten Percent (10%) of NET SALES in each country of the
TERRITORY
where there is PATENT protection for the life of the PATENT or where
there
is MARKET EXCLUSIVITY for the period of such MARKET EXCLUSIVITY and
four
percent (4%) of NET SALES in each country of the TERRITORY if there
is no
PATENT protection or MARKET EXCLUSIVITY.
|
These
payments are to be made in accord with Article 6.2.
6.2
Quarterly
Royalty Reports and Payments
-
STRAKAN shall pay all sums due under
Article
6.1 in United States Dollars. The NET SALES for each country of the TERRITORY
shall be converted into United States Dollars at the relevant U.S. Dollar
spot
exchange rate in the London Financial Times at the end of the calendar quarter.
Within sixty (60) days after the close of each calendar quarter, STRAKAN
shall
submit a written report on the NET SALES for the TERRITORY in sufficient
detail
to enable a calculation of the royalty due in accord with Article 6.1 and
payment of the royalty (if any) due shall be made by wire transfer to a bank
account designated in writing by ACCESS. Prior to commercialization STRAKAN
shall provide one written biannual report and quarterly oral reports from
the
EFFECTIVE DATE at the close of each calendar quarter. Once commercialization
has
begun, then STRAKAN must provide quarterly written reports as soon as reasonably
possible after the close of each calendar quarter, providing an estimate
of the
NET SALES prior to the royalty payment report.
6.3 Books
of Account
-
STRAKAN and its sub-licensees shall maintain true and complete books of account
containing an accurate record of all data necessary for the proper computation
of royalty payments due under this LICENSE. Such records shall be maintained
for
at least five (5) years after the date of the pertinent royalty
payment.
| 6.4 |
Audit
Right
-
ACCESS shall have the right, either through a certified public accountant
employed by ACCESS
or
through a firm of independent public accountants to whom STRAKAN
has no reasonable objection, to examine the books of account of
STRAKAN
at
reasonable times and upon reasonable advance notice (but not more
than
once in each calendar year) for the purpose of verifying the correctness
of any report concerning payment of royalties, manufacturing costs
for
gross margin verification in relation to Article 7.2 or milestone
payments
under Article 6. Such examination shall be made during normal business
hours at the place of business of STRAKAN.
The information furnished as a result of any such examination shall
be
maintained in confidence on the terms specified in Article 10. The
fees
and expenses of such an audit shall be borne by ACCESS.
If any such audit shows any underpayment or overcharge, a correcting
payment or refund shall be made within thirty (30) days of STRAKAN’s
receipt of the auditors’ statement. If such error is material (meaning
+5%),
then if STRAKAN
owes ACCESS
from
such material error, STRAKAN
shall pay to ACCESS the amount due plus interest of eighteen per
cent
(18%) and reasonable accounting fees with respect to such audit.
Should
STRAKAN
fail to make any correcting payment within sixty (60) days from receipt
of
the auditors’ statement, then ACCESS
shall have the right to terminate this LICENSE under Article
16.5.
|
| 6.5 |
Withholding
Tax Payments
-
If any taxes for ACCESS’ account, withholding or otherwise, are levied by
any taxing authority in the TERRITORY in connection with the receipt
by
ACCESS of any amounts payable under Article 6 of this LICENSE according
to
any tax treaty or agreement between the United States and a country
in the
TERRITORY, then STRAKAN shall have the right to pay such taxes to
the
local tax authorities and the payment to ACCESS of the net amount
due
after reduction by the amount of such taxes, and shall provide ACCESS:
|
| (i) |
evidence
of payment of such taxes
|
| (ii) |
indication
of the amount of such tax paid, and
|
| (iii) |
indication
of the country in the TERRITORY and the authority to whom it was
paid.
|
However,
if ACCESS still requires further information, STRAKAN shall promptly provide
that information, if such information is reasonably available.
|
6.6
|
Late
Payments-Any
payments due under Article 6.1 and/or Article 6.7 not remitted
or
deposited by the due date shall bear interest at the current prime
rate
plus two percent (2%) established by a leading New York Bank, such
as
Citibank, as published in the Wall Street Journal. Should STRAKAN
fail to
make any payment within (90) days from its due date, then ACCESS
shall
have the right to terminate this LICENSE under Article 16.5 upon
fifteen
(15) working days written notice to STRAKAN to allow
cure.
|
|
6.7
|
Milestone
Payments-STRAKAN
will pay ACCESS milestone payments totaling Three Hundred Thousand
United
States Dollars ($300,000) for sales of PRODUCT by STRAKAN or its
sub-licensee in the TERRITORY in three (3) installments as
follows:
|
| a) |
$100,000
US payment on cumulative sales of one (1) million UK
pounds
|
| b) |
$100,000
US payments on cumulative sales of five (5) million UK
pounds
|
| c) |
$100,000
US payment on cumulative sales of ten (10) million UK
pounds
|
|
6.8
|
Sub-license
Agreements-STRAKAN
shall promptly provide ACCESS with copies of all sublicense agreements
and
all amendments thereto.
|
| 7.1 |
Manufacturing-STRAKAN
will be allowed to locally manufacture the PRODUCT in the TERRITORY
either
directly, or through a THIRD PARTY contract manufacturer. The active
DRUG
SUBSTANCE shall be sourced from Takeda Chemical Industries Ltd, Osaka,
Japan for ten (10) years from the date of the first commercial sale
of the
respective compound's corresponding preparation in the respective
country
of the TERRITORY under the terms of the BLOCK LICENSE AGREEMENT and
Supply
Agreement between the PRODUCT OWNER and Takeda Chemical Industries,
Ltd.,
dated November 12, 1987.
|
| 7.2 |
STRAKAN's
Gross Margin-Based
on STRAKAN's ex-manufacturing selling price of $8.16, (5.10 UK pounds
based at an exchange rate of $1.60 to one UK pound), ACCESS will
guarantee
STRAKAN a gross margin of sixty five (65) per cent, (gross margin
defined
as ex-manufacturing selling price less material cost of active DRUG
SUBSTANCE, orabase vehicle, tubes, packaging, cost of manufacturing
and
royalty). If this margin cannot be achieved, STRAKAN can only terminate
the Agreement as sole remedy.
|
| 8.1 |
EUROPEAN
COMMUNITY APPROVAL-STRAKAN
shall be responsible, at its own expense (including without limitation,
the cost of PRODUCT required in connection therewith) for obtaining
EUROPEAN COMMUNITY APPROVAL for the PRODUCT and maintenance of APPROVAL
in
the TERRITORY as may be required for sale of PRODUCT. Outside the
TERRITORY, STRAKAN will take all necessary steps upon written notice
from
ACCESS to transfer the relevant EUROPEAN COMMUNITY APPROVAL to
ACCESS or ACCESS' licensing partners in respect of and following
EUROPEAN
COMMUNITY APPROVAL in a particular European Community country
|
listed
in
Appendix C. Notwithstanding the above, STRAKAN will not be responsible for
obtaining price and/or reimbursement approval outside the TERRITORY.
Accordingly, STRAKAN shall diligently prepare from the FDA dossier provided
by
ACCESS and submit an application for EUROPEAN COMMUNITY APPROVAL, following
the
grant of APPROVAL in the United Kingdom. Upon request, STRAKAN shall provide
ACCESS with a copy of the formatted EUROPEAN COMMUNITY APPROVAL dossier and
shall notify ACCESS of the date of filing the application. STRAKAN will consult
with ACCESS on any material requests of the regulatory authority in a particular
European Community country listed in Appendix C that if accepted would result
in
the grant of EUROPEAN COMMUNITY APPROVAL in a particular European Community
country listed in Appendix C on a different basis to that as set out in the
application for EUROPEAN COMMUNITY APPROVAL. STRAKAN shall pay any application
fee levied in respect of the EUROPEAN COMMUNITY APPROVAL. Outside the TERRITORY,
ACCESS' licensees will have the right to access the EUROPEAN COMMUNITY APPROVAL
dossier for registration purposes from STRAKAN at the licensee's expense.
STRAKAN will be reimbursed by ACCESS' licensees for all reasonable costs
involved in transferring the EUROPEAN COMMUNITY APPROVAL dossier. For the
avoidance of doubt, STRAKAN shall not be deemed to be in breach of its
obligations above in the event that during the Mutual Recognition Procedure
to
obtain EUROPEAN COMMUNITY APPROVAL a particular European Community Country
listed in Appendix C refuses to grant such approval on health, safety, efficacy
or other grounds beyond STRAKAN's control or ability to remedy.
|
8.2
|
EUROPEAN
COMMUNITY APPROVAL Date
-
STRAKAN shall notify ACCESS forthwith of the date upon which EUROPEAN
COMMUNITY APPROVAL is granted within each European Community country
listed in Appendix C.
|
| 8.3 |
Clinical
Investigations-STRAKAN
agrees that it will not undertake any clinical or other investigations
with respect to PRODUCT without the prior written approval of ACCESS
and
the PRODUCT OWNER, ACCESS approval not to be unreasonably withheld
or
delayed.
|
| 8.4 |
PRODUCT
Information and Labeling-STRAKAN
and ACCESS agree to consult from time to time on the need for changes
in
product particulars appearing in labeling of packaging and containers
of
PRODUCT or in the PRODUCT information supplied to end users, the
medical
profession or patients. STRAKAN and ACCESS agree to negotiate in
good
faith to their mutual benefit with respect to such changes and STRAKAN
shall provide ACCESS in a timely fashion with copies of all correspondence
relating to such changes passing between STRAKAN and the European
Medicines Evaluation Agency or any relevant regulatory authority
in a
European Community country listed in Appendix
C.
|
| 8.5 |
Filing
of Reports-STRAKAN
shall file all reports that are required for the application for
EUROPEAN
COMMUNITY APPROVAL, including supportive stability data required
for sale
of PRODUCT in finished packs. ACCESS shall cooperate with STRAKAN
and
provide STRAKAN with any information, which ACCESS can reasonably
obtain
from the PRODUCT OWNER that is required for the preparation or filing
of
such reports.
|
| 8.6 |
Adverse
Experiences-
|
| a) |
The
Vice President, Regulatory Affairs of the PRODUCT OWNER will be the
central contact for worldwide adverse experience ("AE") reporting.
|
| b) |
STRAKAN
will report to PRODUCT OWNER any information that it has knowledge
of
concerning any adverse experience in connection with PRODUCT in the
TERRITORY. STRAKAN will be responsible for conducting adequate follow-up
of AE reports, which originate in the TERRITORY. STRAKAN will agree
on a
mechanism for AE reporting with the PRODUCT OWNER within sixty days
(60)
of the EFFECTIVE DATE or the expected date of launch of the PRODUCT
in the
TERRITORY and agree on the timetable for forwarding AE reports for
serious
and non-serious AE's.
|
| c) |
In
the event a recall of the PRODUCT is necessary, STRAKAN will immediately
notify ACCESS and PRODUCT OWNER in a manner which is appropriate
and
reasonable under the circumstances.
|
| d) |
In
the event that STRAKAN is advised by a REGULATORY AUTHORITY in any
country
of the TERRITORY to vary, suspend, revoke or modify the approved
indications for PRODUCT or in some other manner change the status
of an
APPROVAL, STRAKAN will immediately notify ACCESS and PRODUCT OWNER
and in
consultation with ACCESS and PRODUCT OWNER, shall maintain the APPROVAL
in
such form as STRAKAN may, in its discretion, direct and, without
prejudice
to the generality of the foregoing, STRAKAN shall exercise such rights
of
appeal or judicial review as may properly be open to it. Copies of
all
correspondence between STRAKAN and the REGULATORY AUTHORITY relevant
to
such actions shall be furnished to ACCESS and PRODUCT
OWNER forthwith and STRAKAN shall keep ACCESS and PRODUCT OWNER fully
informed on all negotiations that may take
place.
|
|
9.1
|
Minimum
Sales Obligations-STRAKAN
shall adhere to the following minimum unit volume sales obligations
if
there is PATENT protection and/or MARKET EXCLUSIVITY position on
the
PRODUCT in the TERRITORY:
|
*Year
1
50,000
5gm tubes
Year
2
93,000
5gm tubes
Year
3 134,000
5gm tubes
Year
4 157,000
5gm tubes
Year
5 180,000
5gm tubes
Years
6-10 180,000
5gm tubes per year
*
(the first twelve (12) months following the date of first commercial sale
of the
PRODUCT in the TERRITORY).
| 9.2 |
Failure
to meet Minimum Sales Obligations-If
in any Year referred to in Article 9.1 above, STRAKAN fails to achieve
these minimum sales obligations in any such Year, STRAKAN will make
up the
royalty shortfall for such Year by making a cash payment to ACCESS
equal
to the royalty shortfall based on the weighted NET SALES for such
Year. If
STRAKAN fails to meet its minimum sales obligations for two consecutive
Years, ACCESS strictly in the following order shall (a) have the
unilateral right (but not the obligation) to alter the minimum sales
requirements or (b) allow STRAKAN to make up the royalty shortfall
for the
second Year through a cash payment to ACCESS calculated based on
the
average selling price of the Product for such year or (c) appoint
another
licensee on a semi exclusive basis using a new trademark or (d) if
STRAKAN
does not agree to make up the royalty shortfall for the second year
through the cash payment
|
as
described above, terminate the Agreement. For the avoidance of doubt, if
STRAKAN
agrees to make up the royalty shortfall for failing to meet its minimum sales
obligations
for
two
consecutive Years, ACCESS shall have no right to terminate the LICENSE or
appoint another licensee. If STRAKAN fails to meet its minimum sales obligations
for three consecutive Years, ACCESS after consultation with STRAKAN will
have
the right to terminate the LICENSE. For the avoidance of doubt, STRAKAN shall
not be deemed to be in breach of its minimum sales obligations due to material
disruptions in the supply of DRUG SUBSTANCE and/or PRODUCT for reasons beyond
STRAKAN's reasonable control.
|
10.1
|
Each
PARTY shall use good faith efforts to retain in confidence and
not
disclose to any THIRD PARTY each other’s CONFIDENTIAL INFORMATION
disclosed pursuant to the terms of this LICENSE. Such “good faith efforts”
shall mean the same degree of care, but no less than a reasonable
degree
of care, as the receiving PARTY uses to protect its own confidential
information of a like nature.
|
10.2 Excepted
from the obligation of confidence under Article 10.1 is that information
which:
| (a) |
is
available, or becomes available, to the general public without fault
of
the receiving PARTY; or
|
| (b) |
is
obtained by the receiving PARTY without an obligation of confidence
from a
THIRD PARTY (other than a governmental agency or REGULATORY AUTHORITY)
who
is rightfully in possession of such information and is under no obligation
of confidentiality to the disclosing PARTY concerning such information;
or
|
(c)
is
required by law or by court order to be disclosed by the receiving PARTY
in
which
case the receiving PARTY will use good faith efforts to limit such disclosure
to
that required by law and to maintain the confidentiality of the disclosed
information to the extent possible; or
(d)
must
be
necessarily disclosed to REGULATORY AUTHORITIES by STRAKAN
when
applying for APPROVAL or EUROPEAN COMMUNITY APPROVAL;
(e)
is
released from confidentiality in writing by the disclosing PARTY.
For
the
purpose of Article 10.1, a specific item of TECHNOLOGY shall not be deemed
to be
within the foregoing exceptions merely because it is embraced by more general
information in the public domain, or in the possession of the receiving PARTY.
In addition, any combination of features shall not be deemed to be within
the
foregoing exceptions merely because individual features are in the public
domain
or in the possession of the receiving PARTY, unless the combination itself
and
its principle of operation are in the public domain or in the possession
of the
receiving PARTY.
| 10.3 |
Notwithstanding
the provisions of Article 10.1, if the receiving PARTY becomes legally
compelled to disclose any of the disclosing PARTY's CONFIDENTIAL
INFORMATION, the receiving PARTY shall promptly advise the disclosing
PARTY of such required disclosure in order that the disclosing PARTY
may
seek a protective order or such other remedy as the disclosing PARTY
may
consider appropriate in the circumstances. The receiving PARTY shall
disclose only that portion of the CONFIDENTIAL INFORMATION, which
it is
legally required to disclose. Such a disclosure shall not release
the
receiving PARTY with respect to the CONFIDENTIAL INFORMATION so disclosed
except to the extent of permitting the required
disclosure.
|
| 10.4 |
Disclosure
to AFFILIATES, Contractors
-
STRAKAN may disclose CONFIDENTIAL INFORMATION to its AFFILIATES,
sublicensee, consultants and, when permitted herein, its clinical
investigators, contractors (parties under contract with STRAKAN or
its
AFFILIATES for the custom manufacturing or shipping of PRODUCT, conduct
of
clinical studies or for the intention of applying for APPROVAL or
EUROPEAN
COMMUNITY APPROVAL) as may be necessary to exercise the rights granted
|
hereunder
and to obtain APPROVAL and prepare for commercialization of PRODUCT, and
to
commercialize PRODUCT under this LICENSE, under written conditions of
confidentiality at least as stringent as those set out in Articles 10.1,
10.2
and 10.3.
| 10.5 |
Document
Return
-
In the event of termination of this LICENSE under Article 16.2, 16.3,
16.4
(if the breach is by STRAKAN), 16.5 or 16.6 prior to its normal
expiration, STRAKAN will cease their use of the TECHNOLOGY and STRAKAN
and
ACCESS will cease their use of the other PARTY’s CONFIDENTIAL INFORMATION
provided hereunder and, on request, within sixty (60) days, either
return
all such CONFIDENTIAL INFORMATION, including any copies thereof,
in accord
with Article 16.7 or promptly destroy the same and certify such
destruction to the disclosing PARTY; except that such CONFIDENTIAL
INFORMATION that is or has become no longer subject to confidentiality
under Article 10.1 need not be returned or destroyed. Notwithstanding
the
foregoing, STRAKAN may retain such copies of documents as may be
necessary
for the defense of product liability or other litigation or similar
proceedings relating to PRODUCT, and both PARTIES may retain one
copy
thereof in its legal department as a record of what was
transmitted.
|
|
10.6
|
Survival
of Confidentiality
-
Termination of this LICENSE for any reason shall not relieve the
PARTIES
of their obligations under this Article 10. The provisions of this
Article
10 shall survive termination of this LICENSE for ten (10)
years.
|
| 11.1 |
Defense
of Third Party PATENT Claims-
If a claim is made or brought by a THIRD PARTY that manufacture (by
STRAKAN or its nominated custom manufacture), development, use, marketing
or the sale of PRODUCT in the TERRITORY (regardless of use) infringes
a
patent of such THRID PARTY, STRAKAN will give prompt written notice
to
ACCESS of such claim. ACCESS shall have the sole discretion and right
to
seek to dispose of said claim or to conduct the defense of any suit
resulting from such claim if outside the FIELD in the TERRITORY.
STRAKAN
at its option and expense may participate in any suit resulting from
such
claim that may directly affect its market in the FIELD in the
TERRITORY.
|
| 11.2 |
Mutual
Decisions
-
From the EFFECTIVE DATE and using their good faith efforts, STRAKAN
and
ACCESS shall discuss any claim or suit, made or brought by a THIRD
PARTY
for patent infringement that such THIRD PARTY’s patent is infringed by the
manufacture (by STRAKAN or its nominated custom manufacturer),
development, use,
|
marketing
or sale of PRODUCT by STRAKAN or its AFFILIATES in the FIELD in the TERRITORY.
Specifically, STRAKAN and ACCESS shall mutually try to agree on:
| (a) |
the
strategy for such suit or claim, e.g. whether to negotiate a settlement,
xxx or withdraw from the country in the TERRITORY in which infringement
is
claimed;
|
| (b) |
the
basis to be determined for sharing the costs of litigation, damages
awarded, and royalty, if any, to be paid to the THIRD
PARTY;
|
| (c) |
which
Party should conduct the defense or if both STRAKAN and ACCESS should
jointly defend; and
|
| (d) |
the
consequences of such decisions, such as amendment to this LICENSE
with
regard to royalties due to ACCESS or termination of this LICENSE.
|
If
STRAKAN and ACCESS cannot mutually agree with regard to one or more of (a)-(d)
above, the dispute shall be resolved in accord to Article 19.
|
11.3
|
Third
Party License -
The Parties shall use their good faith efforts (either individually
or
together) to negotiate any necessary agreement for royalty payment
to
THIRD PARTIES with a view to enabling the PRODUCT to be commercialized
in
the FIELD in the
|
TERRITORY.
As of the EFFECTIVE DATE, ACCESS is not aware of the need for any such THIRD
PARTY license.
| 12.1 |
Prosecution
by ACCESS
-
ACCESS, at its sole discretion, may take action on its own behalf
and
expense to institute any action or proceeding by reason of infringement
of
any of the PATENTS. If either PARTY learns of any infringement of
a PATENT
by a THIRD PARTY, it shall promptly notify the other
PARTY.
|
ACCESS
shall have the first right, at its own expense, to prosecute all litigation
against a THIRD PARTY infringer who may be infringing a PATENT. STRAKAN shall
provide all reasonable cooperation, including any necessary use of its name,
required to prosecute such litigation. STRAKAN shall be consulted concerning
the
litigation. ACCESS will bear the cost and shall be entitled to any recovery
obtained from such litigation, settlement or compromise thereof until recovery
of all expenses for such litigation has been met. If ACCESS requests STRAKAN
to
participate, then ACCESS shall pay all of STRAKAN's reasonable expenses,
including reasonable counsel fees. Any further recovery above such expenses
of
the PARTIES shall be mutually agreed upon based on the particular claim(s)
in
suit with an equitable division based on each of the PARTIES interests (e.g.,
PATENTS, PRODUCT).
| 12.2 |
Prosecution
by STRAKAN
-
If ACCESS does not prosecute such infringer or otherwise xxxxx such
infringement within ninety (90) days after giving or receiving
notification of such infringement in the TERRITORY, unless an extension
of
the term is mutually agreed upon by the PARTIES, then, STRAKAN shall
have
the right to prosecute such infringer at its own expense in the FIELD
in
the TERRITORY in accord with Article 12.5 and shall be entitled to
retain
any recovery obtained from such litigation, settlement or compromise
thereof. STRAKAN's cost of litigation in any quarter may be credited
against up to fifty (50%) percent of the royalties due to ACCESS
under
Article 6.1 in the following quarter until fully recaptured. However,
STRAKAN shall place all royalties due to ACCESS in escrow from the
date of
filing the suit until the action or proceeding is finally concluded
whereupon:
|
| (i) |
if
the PATENT in the country in the TERRITORY is held valid (whether
infringed or not), then the royalties in escrow (after deduction
of
STRAKAN's cost of litigation as referred to hereinabove) shall be
paid to
ACCESS; or
|
| (ii) |
if
the PATENT in the country in the TERRITORY is held invalid (whether
infringed or not), then (a) the royalties in escrow shall be paid
to
STRAKAN and (b) ACCESS shall reimburse STRAKAN's cost of such litigation
up to fifty thousand dollars (US $50,000) in each country of the
TERRITORY
where suit was determined that a PATENT is
invalid.
|
At
STRAKAN's request, ACCESS shall cooperate with STRAKAN in such litigation,
including joining in said litigation. ACCESS shall also cooperate, at STRAKAN's
expense, including reasonable counsel fees, by way of providing access to
evidence and witnesses available to ACCESS.
| 12.3 |
Prosecution
by neither STRAKAN and ACCESS
-
If the PARTIES mutually agree that neither ACCESS nor STRAKAN will
defend
a particular PATENT in the FIELD in the particular country in the
TERRITORY, then the royalty for that PATENT in that country becomes
four
percent (4%) upon that decision date if the PRODUCT does not secure
MARKET
EXCLUSIVITY for the remainder of the time during which a royalty
is
payable in that country.
|
| 12.4 |
Invalidity
-
In the event that a PATENT in the TERRITORY is finally declared invalid
or
unenforceable in a judicial or administrative proceeding from which
no
appeal is or can be taken, then from and after that date royalties
of four
percent (4%) shall be paid on the basis of that PATENT in the relevant
country of the TERRITORY, for the remainder of the time during which
a
royalty is payable in that country upon that decision date if the
PRODUCT
does not secure MARKET EXCLUSIVITY, subject to the provisions of
Article
12.2, provided, however, that royalties due for other PATENTS in
the
TERRITORY not so held invalid or unenforceable shall not be affected.
If
as a result of the invalidation of a PATENT, the completion for STRAKAN
in
the TERRITORY significantly increases or significant market share
is lost
by STRAKAN, then in good faith STRAKAN and ACCESS shall discuss the
relevant facts and determine whether an amendment to this LICENSE
is
required or if termination under Article 16 should result.
|
| 12.5 |
Settlement
-
Any settlement of any litigation, whether brought by ACCESS or by
STRAKAN,
shall be subject to the prior written consent of both PARTIES, which
consent shall not be unreasonably withheld or
delayed.
|
| 12.6 |
Cooperation
-
Each PARTY shall cooperate with the other PARTY to the extent reasonably
requested in any legal action:
|
| (i) |
brought
by a THIRD PARTY against one PARTY or,
|
| (ii) |
brought
by a THIRD PARTY against both of them or,
|
| (iii) |
taken
against a THIRD PARTY by either PARTY regarding PATENTS in the FIELD
in
the TERRITORY, and each PARTY shall have the right to participate
in any
defense, compromise or settlement to the extent that, in its judgment,
it
may be prejudiced thereby. In addition, STRAKAN shall not settle
any claim
or suit in any manner that shall adversely affect any PATENTS, require
any
payment by ACCESS or reduce the royalty due to ACCESS hereunder without
the prior written consent of ACCESS, except as provided in Article
12.2.
|
|
13.1
|
Compliance
-
STRAKAN agrees to comply with all applicable United States governmental
regulations with respect to export of TECHNOLOGY and any PRODUCT
in the
TERRITORY. STRAKAN agrees not to export or re-export any TECHNOLOGY
or
PRODUCT received from ACCESS or the direct products of such TECHNOLOGY
to
any prohibited country listed in the U.S. Export Administration
Regulations unless
|
properly
authorized by the U.S. Government. STRAKAN shall be responsible for the acts
of
its AFFILIATES, contractors, consultants and sublicensee. STRAKAN assumes
all
liability if it or its AFFILIATES or sublicensee fails to obtain any of the
necessary licenses or commits any violations of the United States Export
Laws or
Regulations (15
C.F.R.
§700 et
seq.).
STRAKAN shall indemnify ACCESS for such acts and for any breach of
compliance.
|
14.1
|
Indemnity
by ACCESS-
ACCESS shall indemnify and hold STRAKAN, its AFFILIATES and sub-licensees,
and their respective agents, directors, officers and employees
harmless
from and against any and all liabilities, claims, demands, damages,
costs,
expenses or money judgements (including reasonable attorneys’ fees and
|
expenses)
incurred by or rendered against any of them for personal injury, sickness,
disease
or death or property damage which directly arise out of :
| (a) |
the
intentional misconduct or negligence of ACCESS;
or
|
| (b) |
the
breach by ACCESS of its representations, warranties or covenants
contained
in this LICENSE.
|
14.2 Indemnity
by STRAKAN
-
STRAKAN shall indemnify and hold ACCESS and its AFFILIATES, and their respective
agents, directors, officers, and employees harmless from and against any
all
liabilities, claims, demands, damages, costs, expenses or money judgements
(including reasonable attorneys’ fees and expenses) incurred by or rendered
against any of them for personal injury, sickness, disease or death or property
damage which directly arise out of:
| (a) |
the
manufacturing, testing, use, promotion, sale or distribution of PRODUCT
by
STRAKAN or its sub-licensee, except for those instances provided
in
Article 14.1 for which ACCESS is obligated to indemnify STRAKAN,
or
|
| (b) |
the
breach by STRAKAN of any of its representations, warranties or covenants
contained in this LICENSE and provided, however, that ACCESS shall
give
STRAKAN notice in writing in accord with Article 18 as soon as practicable
of any such claim or lawsuit and shall permit STRAKAN to undertake
the
defense thereof at STRAKAN’s expense.
However,
|
| (i) |
ACCESS
will cooperate in such defense, subject to payment of reasonable
out-of-pocket expenses, by providing access to witnesses and evidence
available to it. ACCESS shall have the right to participate in any
defense
to the extent that in its reasonable judgment, ACCESS may be prejudiced
thereby; and
|
| (ii) |
in
any claim or suit in which ACCESS seeks indemnification by STRAKAN,
ACCESS
shall not settle, offer to settle or admit liability or damages in
any
such claim or suit without the prior written consent of STRAKAN which
shall not be unreasonably withheld or
delayed.
|
15.1 Belief
of Accuracy
-
| 15.1.1 |
ACCESS
warrants and represents that the PRODUCT, TECHNOLOGY and the CONFIDENTIAL
INFORMATION, transferred or provided to STRAKAN hereunder are believed
to
be accurate and complete as of their current status at ACCESS at
the
EFFECTIVE DATE. However, ACCESS does not warrant or represent that
such
information is or will be sufficient to obtain APPROVAL or to commercially
produce PRODUCT or to commercialize PRODUCT in the
TERRITORY.
|
| 15.1.2 |
ACCESS
warrants and represents that it has procured the rights to the PATENTS
and
subject to the terms of the BLOCK LICENSE AGREEMENT, has full power
and
authority to enter into this LICENSE and grant the licenses granted
hereunder.
|
| 15.1.3 |
ACCESS
warrants and represents that it has not assigned or licensed the
rights to
the PATENTS, TECHNOLOGY or KNOW-HOW for the PRODUCT in the FIELD
in the
TERRITORY to a THIRD PARTY.
|
15.2
STRAKAN
Representations to ACCESS-
| 15.2.1 |
STRAKAN
represents that it will be solely relying on its own evaluation of
the
PRODUCT, TECHNOLOGY and the other CONFIDENTIAL INFORMATION transferred
or
provided to it hereunder and on its own medical and scientific expertise
in using the same in its development and commercialization of
PRODUCT.
|
| 15.2.2 |
STRAKAN
warrants and represents that it has the full power and authority
to enter
into the LICENSE.
|
|
15.3
|
Insurance
-
STRAKAN will obtain an insurance policy for its operations for
clinical
trials and sales of PRODUCT prior to beginning such clinical trials
or
sale of PRODUCT in an amount typical in this industry to protect
ACCESS
from liability under STRAKAN's activities. Such insurance policy
must be
maintained for the term of this LICENSE and a copy of the policy
provided
to ACCESS and attached as Appendix D. Failure to obtain such insurance
and
supply a copy of the policy to ACCESS shall be deemed a breach
under
Article 16.4.
|
| 16.1 |
Term
-
Unless terminated under the provisions of this Article 16, the term
of the
LICENSE shall commence on the EFFECTIVE DATE and shall continue in
full
force and effect on an exclusive basis in each country of the TERRITORY
for the longer of (i) the period of time that the PRODUCT is protected
in
such country by a necessary PATENT, and (ii) ten years (10) from
the date
when the PRODUCT is first put on the
|
market
within the European Union by STRAKAN (or other licensee of ACCESS, if any),
provided that the identified KNOW-HOW remains secret and substantial for
such
ten-year (10) period. Thereafter, this LICENSE shall be automatically extended
on a non-exclusive basis for successive one-year (1) periods unless terminated
by either PARTY by written notice given at least one-hundred and eighty (180)
days before the end of the initial term or any extension thereof.
| 16.2 |
Regulatory
Milestones-If
(a) STRAKAN has been unable to obtain APPROVAL within twenty
four (24)
months of the EFFECTIVE DATE or (b) within thirty six (36) months
of the
EFFECTIVE DATE for EUROPEAN COMMUNITY APPROVAL in France, Germany,
Italy
or Spain, then, unless such failure is due to technical failure of
the
PRODUCT or failure of ACCESS to provide necessary information on
a timely
basis, or due to any of such countries refusing to grant such EUROPEAN
COMMUNITY
|
APPROVAL
on health, safety, efficacy or other grounds beyond STRAKAN's control or
ability
to rectify or remedy, ACCESS strictly in the following order shall (a) have
the
unilateral right (but not the obligation) to extend the time for obtaining
APPROVAL and EUROPEAN COMMUNITY APPROVAL for the PRODUCT (b) after consultation
with STRAKAN to be paid by STRAKAN a $100,000 financial penalty, the payment
of
which shall automatically extend the time to obtain APPROVAL and EUROPEAN
COMMUNITY APPROVAL by twelve (12) months respectively or (c) shall have the
right to terminate the LICENSE. For the avoidance of doubt, if STRAKAN makes
payment to ACCESS of the $100,000 financial penalty under sub-article (b)
then
ACCESS
shall have no right to terminate the LICENSE hereunder in accordance with
this
Article 16.2 unless STRAKAN shall have failed to obtain the APPROVAL and
EUROPEAN COMMUNITY APPROVAL for the PRODUCT as above within the twelve (12)
month extension of time respectively.
| 16.3 |
Failure
to Use License
-
If STRAKAN, its AFFILIATES or sub-licensees shall in a country of
the
TERRITORY have:
|
| (i) |
discontinued
selling the PRODUCT in commercial quantities for a continuous period
of
six (6) months other than due to material disruptions in the supply
of the
DRUG SUBSTANCE and/or PRODUCT for reasons beyond STRAKAN's reasonable
control; or
|
| (ii) |
not
commercialized the PRODUCT in accord with Article 4.6, other than
due to
material disruptions in the supply of DRUG SUBSTANCE and/or PRODUCT
for
reasons beyond STRAKAN's reasonable control then either STRAKAN or
ACCESS
shall have the right to terminate the license granted under Article
2.1 in
respect of such country upon three (3) months written notice, unless
the
discontinuance or failure to commercialize is remedied in such notice
period.
|
Upon
termination of the license in respect of such country, STRAKAN shall promptly
supply to ACCESS all registration information for REGULATORY AUTHORITIES
that is
available to STRAKAN or its AFFILIATES for use by ACCESS, its AFFILIATES
or
sublicensees in such country without compensation to STRAKAN by
ACCESS.
| 16.4 |
Termination
for Breach
-
In the event of a material breach by either ACCESS or STRAKAN of
any of
the obligations contained in this LICENSE, the non-breaching PARTY
shall
be entitled to terminate this LICENSE by notice in writing under
Article
18.1 provided that such notice shall specify the breach or breaches
complained of. If the said breach or breaches are capable of remedy,
the
PARTY committing such breach or breaches shall be entitled to a period
of
sixty (60) days, (fifteen (15) working days for
|
payment
breaches) from the delivery of such notice in which to remedy or to undertake
to
remedy the same. In the case the defaulting PARTY shall fail to remedy the
breach or to undertake to remedy the breach to the satisfaction of the PARTY
not
in breach, the PARTY not in breach shall have the right to terminate this
LICENSE in whole or only terminate those rights and obligations relating
to the
particular breach by notice in writing
to
the
PARTY in default. Failure of a PARTY to exercise its rights under this Article
16.4 shall not be construed as a waiver as to future breaches whether or
not
they are similar.
| 16.5 |
Termination
by ACCESS
-
ACCESS shall have the further right to terminate this LICENSE immediately
on written notice to STRAKAN if:
|
| (a) |
STRAKAN
shall cease to carry on business or shall go into liquidation or
a
receiver shall be appointed to STRAKAN's assets;
or
|
| (b) |
STRAKAN
shall become bankrupt or insolvent or unable to meet any of its financial
obligations on their due dates; or
|
| (c) |
STRAKAN
fails (without curing within fifteen (15) working days of receipt
of a
notice specifying the failure to pay) to meet any of its payments
in
accord with Article 6; or
|
| (d) |
STRAKAN
breaches without cure any of the Export regulations of Article
13.
|
| 16.6 |
Termination
by STRAKAN-If
for any consecutive period of twelve (12) months STRAKAN cannot achieve
a
total aggregate gross margin of sixty five (65) percent in the TERRITORY
(determined by monthly reported gross margin reports and the right
to
audit) based on an ex-manufacturing selling price of $8.16 US (5.10
UK
pounds at a fixed exchange rate of $1.60 to one UK pound) as outlined
in
Article 7, STRAKAN will have the right to terminate this LICENSE.
Gross
margin defined as ex-manufacturing selling price less material cost
of
active DRUG SUBSTANCE, orabase vehicle, tubes, packaging, cost of
manufacturing and royalty.
|
| 16.7 |
On
Termination
-
Upon termination of the license in respect of a particular country
of the
TERRITORY under Article 16.3 or upon termination of this LICENSE
by ACCESS
under Article 16.4, STRAKAN shall in relation to a particular country
or
the TERRITORY as a whole, as the case may be, have a period of six
(6)
months in which to sell its inventory of PRODUCT and during the course
thereof STRAKAN shall:
|
| (a) |
return
to ACCESS all copies of CONFIDENTIAL INFORMATION and any materials
received from ACCESS;
|
| (b) |
pay
to ACCESS all payment and royalties due or accrued at the termination
date
or accruing thereafter in accord with Article
6.1.
|
|
(c)
|
other
than in relation to selling its stock of supplies of the PRODUCT
as
aforesaid, make no further use of any kind of any and all TECHNOLOGY
disclosed hereunder by ACCESS, except to the extent such information
has
become public knowledge other than through fault of STRAKAN, and
make no
further use of the surviving PATENTS;
and
|
|
(d)
|
take
all steps necessary and execute any instruments required to assign
all the
rights relative to any APPROVALS held by STRAKAN to ACCESS or to
ACCESS'
designee, and if such new APPROVALS are obtained by ACCESS or its
designee, STRAKAN agrees to notify the REGULATORY AUTHORITIES to
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transfer
all those APPROVALS of PRODUCTS which are in the name of STRAKAN to ACCESS
or
its designee; and
|
(e)
|
assign
to ACCESS any distributorships, PRODUCT manufacturing agreements
and
sublicense agreements, to the extent they are specific to the PRODUCT
and
are assignable and to the extent such agreements were previously
agreed
with ACCESS to survive termination of this LICENSE; or, at ACCESS'
option,
|
terminate
such agreements. ACCESS makes no commitment to maintain any of STRAKAN's
sublicensee agreements upon termination of this LICENSE.
|
16.8
|
Survival
of Certain Obligations
-
On termination of this LICENSE: the obligations of confidentiality
set
forth in Article 10 shall survive for the time stated therein;
payments
accrued and due under Article 6 shall survive termination; Export
Control
compliance set forth in Article 13 shall survive termination; the
indemnification obligations set forth in Article 14 shall also
survive
termination as to all claims or actions arising from events which
occurred
before termination; and the dispute resolution set forth in Article
19
shall survive termination.
|
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, famine 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 therefor; 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
setting forth the nature of the occurrence, its expected duration and how
that
PARTY's performance is affected 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. The affected PARTY shall
resume
the performance of its obligations as soon as practicable after the Force
Majeure event ceases.
|
18.1
|
Official
-
Any notice, request or communication specifically provided for
or
permitted to be given under this LICENSE must be in writing and
may be
delivered by hand delivery, courier service, or facsimile transmission,
provided that a hard copy of any facsimile transmission is sent
by first
class pre-paid post within twenty four (24) hours of such transmission,
and shall be deemed effective as of the time of actual delivery
thereof to
the addressee. For purposes of notice the addresses of the PARTIES
shall
be as follows:
|
ACCESS:
Access
Pharmaceuticals, Inc.
0000
Xxxxxxxx Xxxxxxx
Xxxxx
000
Xxxxxx,
XX 00000-0000
Attention:
Xxxxx
X.
Xxxx
President
& CEO
Telephone:
000-000-0000
Facsimile:
000-000-0000
With
a
copy to:
Xxxxxxx
Xxxx LLP
000
Xxxxxxx Xxxxxx
Xxxxxx,
XX 00000-0000
Attention:
Xxxx
X.
Xxxxxxxxx III
Telephone:
000-000-0000
Facsimile:
000-000-0000
STRAKAN:
Strakan
Ltd.
Xxxx
X,
Xxxxxxx Xxxxxxx
Xxxxx
Xxxxx
Xxxxxxx
Xxxxxxxx
XX0 0XX
Xxxxxx
Xxxxxxx
Attention: Xxxxxx
XxXxxx
Telephone: 000-00-0000-000000
Facsimile: 011-44-1896-823837
|
18.2
|
Each
PARTY may change its address and its representatives for notice
by the
giving of notice thereof in the manner hereinafter
provided.
|
|
19.1
|
Agreement
to Arbitrate
-
The PARTIES will endeavor to settle amicably any dispute, which
may arise
out of this Agreement. Failing settlement within three (3) months
of such
dispute having arisen, any dispute shall be finally settled by
arbitration
on the initiation in writing of either PARTY, 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 STRAKAN 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 such
other
PARTY's choice and requesting that the
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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.
| 19.2 |
Arbitration
Decision
-
The arbitrators shall base their decision in accordance with and
based
upon all the provisions of this LICENSE 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,
including 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 judgement upon the award may be entered
in
any court of competent jurisdiction.
|
| 19.3 |
Pre-Decision
Settlement
-
Before rendering their final decision, the arbitrators will first
act as
friendly, disinterested mediators for the purpose of helping the
PARTIES
attempt to reach a compromise settlement on the points in
dispute.
|
| 19.4 |
Payment
of Costs
-
The cost of arbitration will be in the discretion of the arbitrators.
|
|
19.5
|
Injunctive
Relief
-
Each of the PARTIES hereto acknowledges and agrees that damages
may not be
an adequate remedy for any material breach or violation of this
Agreement
if such material breach or violation would cause immediate and
irreparable
harm (an "Irreparable Breach"). Accordingly, in the event of a
threatened
or ongoing Irreparable Breach, each PARTY hereto shall be entitled
to
seek, in any state or federal court in the State of Delaware, equitable
relief of a kind appropriate in light of the nature of the ongoing
threatened Irreparable Breach, which relief may include, without
limitation, specific performance or injunctive relief; provided
however,
that if the PARTY bringing such action is unsuccessful in obtaining
the
relief sought, the moving PARTY shall pay
|
the
non-moving PARTY's reasonable costs, including attorney's fees, incurred
in
connection with defending such action. Such remedies shall not be the PARTIES'
exclusive remedies, but shall be in addition to all other remedies provided
in
this Agreement.
| 20.1 |
Assignment
-
Neither this LICENSE 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 or delayed.
|
| 20.2 |
Consolidation,
Reorganization or Merger
-
Should STRAKAN be consolidated, reorganized or merged with another
entity,
this LICENSE may not be assigned to the successor entity or the assignee
of all or substantially all of STRAKAN'S business and assets related
to
PRODUCT without ACCESS' prior written consent, which consent will
not be
unreasonably withheld or delayed. It being understood for consent
to be
obtained that provisions for payments to ACCESS by such entity must
remain
as in Article 6.
|
| 20.3 |
Effect
on Successors and Assignees
-
This LICENSE shall inure to the benefit of and be binding upon such
successors and permitted assignees.
|
| 21.1 |
Amendments
-
This LICENSE may be amended only in writing executed by both
PARTIES.
|
| 21.2 |
Publications
-
Any publications shall require the mutual consent of STRAKAN and
ACCESS
which consent shall not be unreasonably
withheld.
|
| 21.3 |
Press
Releases
-
Neither PARTY shall issue any press release in whatever form, or
make
public, in whatever form, information regarding the BINDING LETTER
OF
INTENT or this LICENSE without prior written approval of the other
PARTY,
except as required by applicable law and
regulations.
|
| 21.4 |
Entirety
of Agreement
-
This LICENSE sets forth the entire agreement and understanding between
the
PARTIES hereto with respect to PRODUCT in the FIELD for its
commercialization in the TERRITORY, although it is acknowledged and
agreed
that for STRAKAN to be able to commercialize the PRODUCT in accordance
with the terms of this LICENSE then STRAKAN will need a source of
supply
of the DRUG SUBSTANCE as referred to in Article 7.1. The PARTIES
agree
that this LICENSE supersedes the BINDING LETTER OF INTENT and that
the
confidentiality provisions contained in the BINDING LETTER OF INTENT
are
in force until the EFFECTIVE DATE and thereafter this LICENSE supersedes
and replaces the BINDING LETTER OF
INTENT.
|
| 21.5 |
Severability
-
If any term or provision under this LICENSE is deemed invalid under
the
laws of a particular country or jurisdiction, the invalidity shall
not
invalidate the whole LICENSE but it shall be construed as if not
containing that particular term or provision and the rights and
obligations of the PARTIES shall be construed and enforced accordingly.
The PARTIES shall negotiate in good faith a substitute provisions
in
compliance with the law to as nearly as possible retain the PARTIES'
intent in legally valid language.
|
| 21.6 |
Waivers,
Cumulative Remedies
-
A waiver by either PARTY of any term or condition of this LICENSE
in any
one instance shall not be deemed construed to be a waiver of such
term or
condition for any similar instance in the future or of any subsequent
breach hereof. All rights, remedies, undertakings, obligations and
agreements contained in this LICENSE shall be cumulative and none
of them
shall be a limitation of any other remedy, right, undertaking, obligation
or agreement of either PARTY.
|
| 21.7 |
Independent
Contractor
-
This LICENSE shall not create an agency, partnership, joint venture
or
employer/employee relationship between the PARTIES. ACCESS and STRAKAN
each hereby agrees not to represent itself in any of such capabilities
in
any manner whatsoever. The sole relationship established by this
LICENSE
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.
|
| 21.8 |
Headings
-
Headings in this LICENSE are included herein for ease of reference
and
shall not affect the meaning of the provisions of this LICENSE, nor
shall
they have any other legal effect.
|
| 21.9 |
Other
Documents
-
Each PARTY agrees to execute, as reasonably required, such additional
papers or documents in customary legal form and to make such governmental
filings or applications as may be necessary or desirable to effect
the
purposes of this LICENSE and carry out its
provisions.
|
ACCESS
PHARMACEUTICALS, INC. STRAKAN
LTD
By: /s/
Xxxxx
X. Xxxx By: /s/Xxxxxx
XxXxxx
Name: Xxxxx
X.
Xxxx Name: Xxxxxx
XxXxxx
Title: President
& CEO Title: Director
of Legal Affairs
Date: -August
13, 1998 Date: -August
14, 1998
APPENDIX
A - BINDING LETTER OF INTENT
APPENDIX
B-PATENTS
APPENDIX
C- MARKETS
Austria Italy
Belgium Luxembourg
Denmark Netherlands
Finland Portugal
France Republic
of Ireland
Germany Spain
Greece Sweden
United
Kingdom
APPENDIX
D-
CLINICAL
TRIALS INSURANCE
APPENDIX
E
BLOCK
LICENSE AGREEMENT