EXHIBIT
10.43
EXECUTED
VERSION
Portions
of this Exhibit have been omitted pursuant to a request for
confidential treatment.
The
omitted portions are marked ***** and have been filed separately
with the Commission
COLLABORATION
AND SUPPLY AGREEMENT
This
COLLABORATION AND SUPPLY AGREEMENT (this “AGREEMENT”)
is made and entered into as of February 11, 2009 (the
“EFFECTIVE DATE”).
by and
between
DOR
BioPharma Inc. , a
Delaware corporation having its principal office at 850 Bear Tavern
Road, Suite 201, Ewing, New Jersey 08628 (the
“COMPANY”), and Enteron Pharmaceuticals, Inc. ,
a wholly owned subsidiary of the COMPANY, (“ENTERON”,
and together with the COMPANY, “DOR”), each
and
SIGMA-TAU
Pharmaceuticals, Inc. , a
Nevada corporation having its principal office at 9841
Washingtonian Blvd., Suite 500, Gaithersburg, MD 20878 (hereinafter
referred to as “STPI”).
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DOR
has developed and is developing, through its research activities,
Beclomethasone Dipropionate (orBec ®
) and
owns and/or controls the related KNOW-HOW and PATENT RIGHTS (as
hereinafter respectively defined in Article 1); and
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DOR
and STPI signed on January 3, 2007 a Letter of Intent and on
November 26, 2008 a Letter of Intent, each of which is related,
inter alia , to Beclomethasone Dipropionate
(orBec ®
),
both of which are superseded by this AGREEMENT; and
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STPI
desires to obtain from DOR the right to market, distribute and sell
the PRODUCT and AG PRODUCT in the FIELD in the TERRITORY (as
hereinafter respectively defined in Article 1); and
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DOR
is willing to grant to STPI such rights in the TERRITORY, under the
terms and conditions hereinafter set forth; and
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both
DOR and STPI are interested in the further development of
Beclomethasone Dipropionate in all therapeutic areas, diseases or
conditions and in the commercial exploitation of the results of
such further development.
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NOW,
THEREFORE , in
consideration of the foregoing premises and of the mutual covenants
of the parties hereinafter contained, the parties hereto agree as
follows:
The
following terms as used in this AGREEMENT have the meanings set
forth below:
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“
AFFILIATED COMPANIES ” or “ AFFILIATES
” means: (i) an organization more than fifty percent (50%) of
the voting stock of which is owned and/or controlled directly or
indirectly by either party; (ii) an organization which directly or
indirectly owns and/or controls more than fifty percent (50%) of
the voting stock of either party; (iii) an organization which is
directly or indirectly under common control of either party through
common shareholdings.
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“
AGENCY ” means any regulatory authority, including the
FDA, responsible for granting any marketing registration or pricing
approval, if applicable, necessary so the PRODUCT and AG PRODUCT
may be marketed and sold in the TERRITORY.
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“
AG PRODUCT ” means a generically-labeled version of
the PRODUCT ( i.e. , such product does not bear the
TRADEMARK) supplied by DOR and sold by STPI and/or its
sub-distributors or permitted sublicensees.
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“
AGREEMENT ” has the meaning set forth in the
introductory paragraph.
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“
APPROVAL ” or “ APPROVED ”
means all necessary approvals granted by the appropriate AGENCY for
any country in the TERRITORY for the manufacture, sale and
distribution of the PRODUCT and AG PRODUCT for an indication(s),
which may include the FDA for the U.S.
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“
APPROVED NEW INDICATION ” means a NEW INDICATION that,
pursuant to Article 5.2, each of the parties, in its sole
discretion, has agreed to develop.
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“
ARBITRATOR ” has the meaning set forth in Appendix
C.
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“
cGMP ” means the current standards for the manufacture
of drugs, as set forth in the U.S. Food, Drug and Cosmetics Act and
applicable FDA regulations (including 21 C.F.R. Parts 210 and 211)
and guidances promulgated thereunder, as amended from time to
time.
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“
CODE ” has the meaning set forth in Article
15.2.
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“
COMMERCIALIZATION ” or “
COMMERCIALIZE ” means any and all activities directed
to the distribution, promotion, offer for sale and sale of an
APPROVED PRODUCT and AG PRODUCT, including marketing, promoting,
detailing, distributing, offering to sell and selling, importing
for sale, conducting post-marketing human clinical studies and
interacting with any AGENCY regarding the foregoing. For
the avoidance of doubt, the term “Commercialization” or
“Commercialize” does not include the right to
manufacture or use. When used as a verb, “to
Commercialize” and “Commercializing” means to
engage in Commercialization and “Commercialized” has a
corresponding meaning.
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“
COMPANY ” has the meaning set forth in the
introductory paragraph.
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“
CONFIDENTIAL INFORMATION ” has the meaning set forth
in Article 3.3.
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“
CONTROL ” means possession of the ability, whether by
ownership or license, to grant a license or sublicense as provided
for herein without violating the terms of any agreement, securing
consent or other arrangements with any third party.
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“
DEVELOPMENT PLAN ” means the schedule, attached hereto
as Appendix A describing all future activities, relevant budget and
timelines related to the development of the PRODUCT for the
treatment of GI GVHD, including the preclinical, safety, clinical,
technical, manufacturing (CMC) and regulatory development of the
PRODUCT.
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“
DILIGENT EFFORTS ” means, with respect to a party, the
carrying out of obligations in a diligent and sustained
manner using efforts not less than the efforts that a US
based pharmaceutical company of similar size to such party devotes
to a product of similar market potential, profit potential or
strategic value resulting from its own research efforts, based on
conditions then prevailing, but excluding consideration of any
obligation to the other party under this AGREEMENT but in no event
less than the efforts of a US based pharmaceutical company of
similar size to such party. DILIGENT EFFORTS requires,
inter alia , that each party: (i) promptly
assign responsibility for such obligations to specific employee(s)
who are held accountable for progress and monitor such progress on
an on-going basis, (ii) set and consistently seek to achieve
specific and meaningful objectives for carrying out such
obligations, and (iii) consistently make and implement decisions
and allocate resources designed to advance progress with respect to
such objectives.
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“
DISCLOSING PARTY ” has the meaning set forth in
Article 3.3.
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“
DOR ” has the meaning set forth in the introductory
paragraph.
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“
EFFECTIVE DATE ” has the meaning set forth in the
introductory paragraph.
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“
ENTERON ” has the meaning set forth in the
introductory paragraph.
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“
ESTIMATED QUANTITIES ” has the meaning set forth in
Article 8.2.
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“
EUROPEAN TERRITORY ” means Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Ireland, Italy (including the Republic of San Marino and
the Vatican City), Latvia, Lithuania, Luxembourg, Malta, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, The Netherlands and
the United Kingdom, as well as any other country entering the
European Union, Iceland, Norway and Switzerland (including
Liechtenstein).
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“
EXECUTIVE COMMITTEE ” has the meaning set forth in
Article 4.3.
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“
FDA ” means the United States Food and Drug
Administration and any successor agency thereto.
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“
FIELD ” means the diagnosis, treatment and/or
prevention of any and all diseases and conditions.
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“
FIRM ORDER ” has the meaning set forth in Article
8.3.
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“
FIRST COMMERCIAL SALE ” shall mean the first
commercial sale by STPI or any of its AFFILIATES or its
distributors of a PRODUCT to an independent third party in the
TERRITORY. A sale or transfer which is not for value,
including for clinical trial purposes, shall not constitute a FIRST
COMMERCIAL SALE.
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“
FIRST PRODUCT ” means the PRODUCT for the treatment of
GI GVHD in humans.
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“
FIXED COMPONENT ” has the meaning set forth in
Appendix C.
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“
FULLY BURDENED MANUFACTURING COST ” means with respect
to the PRODUCT and AG PRODUCT the fully-burdened cost of
manufacturing, assembling, filling, and secondary packaging of the
PRODUCT and AG PRODUCT packaged for shipment to the receiving party
expressed on a per unit manufactured basis, including the cost
of:
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material,
excipients, primary and secondary packaging and labeling material,
and
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direct
labor of supplying party employees (including basic wages, labor
and related payroll taxes and benefits) incurred or spent in the
actual production, filling, packaging and labeling of the PRODUCT
and AG PRODUCT, including for reasonable and normal quality
assurance, purchasing and manufacturing facility operations,
and
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overhead
of supplying party (including operating expenses, indirect labor
and related payroll taxes and benefits, depreciation, taxes,
insurance, rent, repairs and maintenance, and supplies) incurred or
spent in support of the actual production, filling, packaging and
labeling of the PRODUCT and AG PRODUCT, but not for any cost of any
unused manufacturing capacities that supplying party or its third
party sub-contract manufacturer may have in excess of the
requirements contained in the forecasts provided by receiving party
in connection with this AGREEMENT, and
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interim
transportation, or any related transportation cost including
tertiary packaging and storage of the PRODUCT and AG PRODUCT (for
greater clarity, such storage cost does not include the cost of
inventory) or any part thereof as incurred or spent by supplying
party in connection with the supply of the PRODUCT and AG PRODUCT
pursuant to the terms of this AGREEMENT, and
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any
third party sub-contract manufacturer as invoiced to supplying
party. Supplying party shall provide to receiving party
(within one month of the EFFECTIVE DATE) the prices in effect for
each sub-contract manufacturer.
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For
the avoidance of doubt, the term “Fully Burdened
Manufacturing Cost” does not include any so called
“profit margin” for DOR, such profit margin on the sale
of PRODUCT to STPI being represented by the PERCENTAGE COMPONENT as
set forth in Appendix C attached hereto.
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“
GENERIC COMPETITION ” shall exist for a given PRODUCT
when a GENERIC PRODUCT with the same labeled indication as the
PRODUCT COMMERCIALIZED by STPI in a given country of the TERRITORY
enters the market and the NET SALES of the PRODUCT during any three
(3) month rolling period are at least ten percent (10%) lower than
the amount of NET SALES of that PRODUCT in that same country during
the three (3) month period preceding the APPROVAL of such GENERIC
PRODUCT (in terms of US Dollar, or equivalent legal currency of the
given country).
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“
GENERIC PRODUCT ” means a product that is
APPROVED by an AGENCY (or successor agency) that contains the
SUBSTANCE or salts or esters of the SUBSTANCE and utilizes the same
route of administration as the PRODUCT.
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“
GI GVHD ” means gastrointestinal graft vs. host
disease.
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“
IMPROVEMENT ” means any change, improvement,
development or modification of the PATENT RIGHTS or KNOW-HOW in the
FIELD that is made or created after the EFFECTIVE DATE and relates
to the PRODUCT, AG PRODUCT or the SUBSTANCE or any method of use or
manufacture related thereto.
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“
INITIAL TERM ” has the meaning set forth in Article
14.1
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“
INSOLVENT PARTY ” has the meaning set forth in Article
15.2.
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“
JOINT DEVELOPMENT COMMITTEE ” means a committee with
the authority to review, recommend and coordinate any research,
development and regulatory activities related to the PRODUCT in the
FIELD in the TERRITORY.
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“
JOINT COMMERCIALIZATION COMMITTEE ” means a committee
with the authority to review, recommend and coordinate any
COMMERCIALIZATION activities related to the PRODUCT and AG PRODUCT
in the TERRITORY.
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KNOW-HOW ” means all information and data, technical
information, trade secrets, specifications, instructions,
processes, formulae, expertise and information relating to the
SUBSTANCE and the PRODUCT and its sale in the FIELD owned by or
under the CONTROL of DOR or any AFFILIATE thereof as of the
EFFECTIVE DATE or during the term of this AGREEMENT. Such KNOW-HOW
shall include all biological, chemical, pharmacological,
biochemical, toxicological, pharmaceutical, physical and
analytical, safety, quality control, manufacturing, preclinical and
clinical data, instructions, processes, formulae, expertise and
information, relevant to the sale of the SUBSTANCE which may be
useful in the sale of the SUBSTANCE or the PRODUCT.
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“
MARKETING AUTHORIZATIONS ” mean the authorizations
issued by the AGENCY which are necessary for the marketing, use,
distribution and sale of the PRODUCT and AG PRODUCT in the
TERRITORY.
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“
MCDONALD ” has the meaning set forth in Article
2.7.
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MCDONALD LICENSE ” has the meaning set forth in
Article 2.7.
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“
NDA ” means the New Drug Application and all
amendments and supplements thereto for the PRODUCT submitted
by DOR to the FDA, including all documents, data and other
information included in an accepted NDA submission for APPROVAL to
market and sell the PRODUCT in the TERRITORY.
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“
NET SALES ” mean, with respect to each PRODUCT and AG
PRODUCT, the gross invoiced sales price of such PRODUCT and AG
PRODUCT billed by or on behalf of STPI, its AFFILIATES,
sub-licensees (if permitted), distributors or agents to third
parties on sales of a PRODUCT and AG PRODUCT in bona
fide arm’s length transactions in the TERRITORY, less
the following deductions, determined in accordance with U.S.
generally accepted accounting principles as then in effect and
consistently applied, to the extent included in the gross invoiced
sales price for such PRODUCT or AG PRODUCT or otherwise directly
paid or incurred by STPI, its AFFILIATES or sub-licensees (if
permitted), distributors or agents with respect to the sale of such
PRODUCT and AG PRODUCT:
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normal
and customary trade and quantity discounts actually allowed and
properly taken directly with respect to sales of such PRODUCT and
AG PRODUCT;
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normal
and customary amounts repaid or credited by reason of rejections,
returns and allowances;
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normal
and customary third party cash rebates and chargebacks related to
sales of the PRODUCT and AG PRODUCT, if and to the extent allowed
under applicable laws of the TERRITORY (including shelf stock
adjustments in the case of an AG PRODUCT);
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tariffs,
duties, excise, sales, value-added or other taxes (other than taxes
based on income);
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normal
and customary cash discounts for timely payment;
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normal
and customary discounts pursuant to indigent patient programs and
patient discount programs, including without limitation coupon
discounts and co-pay assistance programs; and
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any
other normal and customary specifically identifiable costs or
charges included in the gross invoiced sales price of such PRODUCT
falling within categories substantially equivalent to those listed
above.
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Sales
from STPI to its AFFILIATES or sub-licensees (if permitted),
distributors or agents shall be disregarded for purposes of
calculating NET SALES. Any of the items set forth above
that would otherwise be deducted from the invoice price in the
calculation of NET SALES but which are separately charged to third
parties shall not be deducted from the invoice price in the
calculation of NET SALES. No sale of PRODUCT or AG
PRODUCT will be for any consideration other than cash.
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“
NEW INDICATION ” means any indication other than for
the treatment of GI GVHD which the JOINT DEVELOPMENT COMMITTEE
agrees to develop and for which STPI or its AFFILIATES are granted
exclusive COMMERCIALIZATION rights hereunder.
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“
PATENT RIGHTS ” means all the patents and the patent
applications claiming the SUBSTANCE and/or the PRODUCT (as the case
may be) or its use and manufacture in the FIELD owned and/or under
the CONTROL of DOR as listed in Appendix B to this AGREEMENT, as
well as: (i) all patents arising from said applications; (ii) any
additions, divisions, continuations, continuations-in-part,
amendments, amalgamations and reissues of such applications or
patents; (iii) any confirmation, importation or registration
patents thereof or therefor; and (iv) any extensions and renewals
of all such patents and/or patent applications in whatever legal
form and/or by whatever legal title they are granted, including
Supplementary Protection Certificate(s) or equivalent.
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“
PERCENTAGE COMPONENT ” has the meaning set forth in
Appendix C.
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“
PHARMACOVIGILANCE AGREEMENT ” means the agreement that
defines how the parties are to cooperate to enable each of them to
comply with its respective obligations under applicable laws,
regulations and guidelines with regard to the adverse event
collection, evaluation, reporting and communicating any safety
issues for the PRODUCT, both pre- and post-marketing and to enable
each party to satisfy its duty of care, which the parties hereto
shall negotiate in good faith and enter into within sixty (60) days
of the EFFECTIVE DATE.
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PHASE 3 TRIAL ” means the clinical study BDP-GVHD-03
entitled, “A Phase 3, Randomized, Double-Blind,
Placebo-Controlled, Multi-Center Study of the Safety and Efficacy
of orBec ®
(Oral
Beclomethasone 17,21-Dipropionate) in Conjunction with Ten Days of
High-Dose Prednisone Therapy in the Treatment of Patients with
Gastrointestinal Graft vs. Host Disease”.
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“
PRODUCT ” means any product in finished pharmaceutical
form APPROVED for use, manufacture and sale in the FIELD containing
the SUBSTANCE.
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“
QUALITY ASSURANCE AGREEMENT ” shall have the meaning
set forth in Article 6.3 of this AGREEMENT, which the parties
hereto shall negotiate in good faith and enter within sixty (60)
days of the EFFECTIVE DATE.
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“
RECEIVING PARTY ” has the meaning set forth in Article
3.3.
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“
ROFN NOTICE ” has the meaning set forth in Article
2.2.
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“
SOLVENT PARTY ” has the meaning set forth in Article
15.2.
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“
SPECIFIED INDICATION ” has the meaning set forth in
Article 2.8.
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“
SUBSTANCE ” means Beclomethasone
Dipropionate.
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“
SUPPLY PRICE ” means the supply price for the PRODUCT
and AG PRODUCT as set forth in Appendix C attached
hereto.
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“
TERRITORY ” means the United States of America
(including its territories and possessions, as well as Puerto
Rico), Canada and Mexico.
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“
TRADEMARK ” means orBec ®
as
well as any and all trademark/s, their back-ups and clones, which
shall be owned or under the CONTROL of DOR or of any of its
AFFILIATED COMPANIES and shall be used to identify the PRODUCT in
the TERRITORY, including domain names.
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“
VALID CLAIM ” means, on a country-by-country basis, a
granted claim within the PATENT RIGHTS which has not been held
invalid and/or unenforceable in a decision of a patent office,
court or other government agency of competent jurisdiction,
unappealable or unappealed within the time frame allowed for
appeal.
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It is
understood that the definitions above shall have the same meaning
regardless of whether a term is used in the singular or plural
form. Additionally, as used in this AGREEMENT, unless
the context otherwise requires: Section, Schedule, Article and
Exhibit references are intended to refer to this AGREEMENT; the
words “hereof”, “herein” and
“hereunder”, and words of similar import, shall refer
to this AGREEMENT as a whole, and not to any particular provision
of this AGREEMENT; and the term “include” and
derivations thereof are not intended to apply any limitation to the
item(s) specified.
(The
information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately
filed with the Commission.)
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Subject
to the terms and conditions hereof, DOR hereby appoints STPI as its
exclusive distributor of PRODUCTS and AG PRODUCTS in the FIELD in
the TERRITORY (even as to DOR), and, in connection therewith and to
support the distribution rights granted hereunder, grants to STPI
and STPI hereby accepts an exclusive (even as to DOR) license, with
no right to grant sub-licenses, to COMMERCIALIZE the PRODUCT and AG
PRODUCT in the FIELD in the TERRITORY, under the TRADEMARK, the
PATENT RIGHTS and under the KNOW-HOW, including marketing,
detailing, conducting post-marketing human clinical studies and
interacting with any AGENCY regarding the foregoing. For
purposes of clarification, STPI shall not have the right to
develop, modify, manufacture or have manufactured the SUBSTANCE or
the PRODUCT or AG PRODUCT, except as authorized by the JOINT
DEVELOPMENT COMMITTEE and agreed between the parties and subject to
Article 8.9 below. Subject to the terms and conditions
hereof and solely in support of the rights granted hereunder in the
remainder of the AGREEMENT, DOR hereby agrees that, with respect to
any third party, it will exclusively manufacture and supply STPI
with all STPI’s requirements of the PRODUCT and AG PRODUCT in
the FIELD in the TERRITORY. STPI shall have the right to
appoint distributors of the PRODUCT and AG PRODUCT, provided
, however , in each case such distributor agrees in writing
to abide by the terms of this AGREEMENT and, in the case of a
distributor that is not an AFFILIATE of STPI, such distributor is
approved in advance by DOR, which approval shall not be
unreasonably withheld or delayed. STPI shall notify DOR
of any AFFILIATED distributor promptly upon their
appointment.
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Regulatory
. DOR
shall be the holder of the MARKETING
AUTHORIZATIONS. DOR shall provide to STPI
copies of any Investigational New Drug or other health registration
documents and amendments or supplements thereto filed with the FDA
(or other similar AGENCY) by DOR and all correspondence to and from
such AGENCY (or other similar AGENCY) relevant to the SUBSTANCE or
the PRODUCT in the FIELD in the TERRITORY.
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Assignment
of Improvements . Subject
to the terms and conditions hereof, STPI hereby assigns to DOR the
IMPROVEMENTS made, invented or conceived by STPI (and its
AFFILIATES but only if such AFFILIATES are appointed as
distributors hereunder or receive any CONFIDENTIAL INFORMATION of
DOR) after the EFFECTIVE DATE and agreed to take any and all
actions, make and execute any and all assignments and make any
filings in order to facilitate the foregoing.
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No
Sale Outside Territory .
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During
the term hereof, STPI shall not and shall cause its AFFILIATES not
to, directly or indirectly, including through the use of one or
more agents or persons with whom STPI and/or its Affiliates are in
privity of contract: (i) sell, distribute or otherwise dispose of;
or (ii) grant any license or other right or otherwise distribute or
dispose of, PRODUCT in the FIELD outside the TERRITORY.
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During
the term hereof, DOR shall not and shall cause its AFFILIATES not
to, directly or indirectly, including through the use of one or
more agents or persons with whom DOR and/or its Affiliates are in
privity of contract: (i) sell, distribute or otherwise dispose of;
or (ii) grant any license or other right or otherwise distribute or
dispose of, PRODUCT in the FIELD within the TERRITORY.
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Exclusive
Relationship in GI GVHD .
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Except
pursuant to terms of this Agreement, during the term hereof, STPI
shall not, itself or through any AFFILIATE, COMMERCIALIZE (i) a
product for the treatment or prevention of GI GVHD or any APPROVED
NEW INDICATION in the TERRITORY or (ii) a PRODUCT in the TERRITORY
in the FIELD.
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Except
pursuant to terms of this Agreement, during the term hereof, DOR
shall not, itself or through any AFFILIATE, COMMERCIALIZE (i) a
product for the treatment or prevention of GI GVHD or any NEW
INDICATION in the TERRITORY or (ii) a PRODUCT in the TERRITORY in
the FIELD.
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McDonald
License . STPI
acknowledges that the certain of the rights granted hereunder are
rights which DOR has received through the Exclusive License
Agreement dated as of November 24, 1998 (the “MCDONALD
LICENSE”) by and between George McDonald
(“MCDONALD”) and ENTERON, a copy of which is attached
hereto as Appendix E, and which contains certain terms and
conditions set forth therein. Without limiting the
foregoing, STPI expressly acknowledges the reservation of rights of
MCDONALD set forth in Sections 2B(vi) and (vii). STPI
further acknowledges and agrees that any information provided
herein to DOR by STPI hereunder may be included in one or more
development reports made to MCDONALD pursuant to Section 3A of the
MCDONALD LICENSE. STPI further acknowledges that all
representations and warranties made in this AGREEMENT are made by
DOR and not MCDONALD, who has specifically disclaimed
representations as set forth in Section 4D of the MCDONALD
LICENSE. STPI agrees to reasonably cooperate with DOR to
enable DOR to fulfill its obligations under Section 5 of the
MCDONALD LICENSE. Neither STPI nor any distributor of
STPI shall use the trade names or marks of MCDONALD (including any
contraction, abbreviation or simulation of the foregoing) in
connection with the COMMERCIALIZATION of any PRODUCT except where
required by law. STPI agrees that it shall not enter
into any discussions or communications with MCDONALD, directly or
indirectly, during the term of this AGREEMENT regarding any license
or transaction under this AGREEMENT, except in respect of
COMMERCIALIZATION of the PRODUCT. STPI shall not
intentionally take any action or omit to take any
action which would cause DOR to be in default under the MCDONALD
LICENSE. Notwithstanding anything to the contrary
contained in this AGREEMENT, during the term of this AGREEMENT, (i)
DOR shall provide STPI with copies of any notices provided by DOR
to MCDONALD which relate to any claim or action by DOR to terminate
the MCDONALD LICENSE and (ii) DOR shall not terminate the MCDONALD
LICENSE pursuant to Section 6E of the MCDONALD LICENSE, as such
Section may be amended. The parties agree that
irreparable damage would occur in the event the obligations set
forth in the preceding sentence were not performed in accordance
with the terms thereof and that STPI shall be entitled to
specific performance of the terms thereof in addition to any other
remedy at law or in equity, including monetary damages, that may be
available to it. The COMPANY agrees that ENTERON shall
remain a wholly owned subsidiary of the COMPANY during the term of
this AGREEMENT, provided , however , the COMPANY may
merge ENTERON with and into the COMPANY at its
discretion.
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Notwithstanding
the rights provided in Article 2.1, STPI (i) shall have the right
to market, sell, offer for sale, and have sold AG PRODUCT for a
labeled indication (the “SPECIFIED INDICATION”) only
beginning (A) on the date on or, with DOR’s prior written
consent, not to be unreasonably withheld, prior to the anticipated
date that a third party sells or offers for sale a
generically-labeled version of the PRODUCT APPROVED for the
SPECIFIED INDICATION for which such PRODUCT is APPROVED or (B) if
applicable, upon (or as part of) settlement of a litigation under
Article 10.3 that allows a third party to sell or offer for sale a
generically-labeled version of the PRODUCT APPROVED for the
SPECIFIED INDICATION and (ii) shall not have a general right
to sublicense, but shall have the limited right to grant
sublicenses only under its rights to market, sell, offer for sale,
and have sold AG PRODUCT for the SPECIFIED INDICATION and only in
connection with settlement of a litigation under Article 10.3 that
allows a third party to sell or offer for sale a
generically-labeled version of the PRODUCT APPROVED for the
SPECIFIED INDICATION, provided that STPI has obtained the consent
of DOR and MCDONALD to such settlement to the extent required under
Article 10.3. STPI will at all times remain responsible
to DOR for all of its obligations under this AGREEMENT and shall be
responsible for the acts or omissions of its sublicensees in
exercising rights granted hereunder. Each sublicense
granted by STPI shall be consistent with the terms of this
AGREEMENT, and STPI shall furnish DOR a copy of any such sublicense
it grants.
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EXCHANGE
OF INFORMATION, CONFIDENTIALITY, PHARMACOVIGILANCE.
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DOR
shall promptly disclose, at its own cost, to STPI on an ongoing
basis during the term of this AGREEMENT, in writing, or via
mutually acceptable electronic media, copies or reproductions of
all PRODUCT-related information under the CONTROL of DOR, but only
to the extent not previously disclosed to STPI, that are reasonably
necessary or useful for STPI and its sub-distributors to
COMMERCIALIZE the PRODUCT in the TERRITORY, including any KNOW-HOW
and PATENT RIGHTS under the CONTROL of DOR.
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Furthermore,
each party shall promptly disclose to the other through the JOINT
DEVELOPMENT COMMITTEE on an ongoing basis during the term of this
AGREEMENT any and all progress made on development and regulatory
activities relating to the SUBSTANCE and/or the PRODUCT. STPI shall
be informed in advance of any FDA meeting/request related to such
development and shall have the right to send up to two (2)
representatives to attend to such FDA meetings.
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Both
DOR and STPI agree to keep and have kept in strict confidence all
confidential information and data (hereinafter “CONFIDENTIAL
INFORMATION”) received from the other party under the terms
of this AGREEMENT. DOR and STPI agree to use CONFIDENTIAL
INFORMATION only for the purposes of this AGREEMENT and pursuant to
the rights granted by the recipient under this AGREEMENT. In
particular DOR and STPI agree not to disclose such information and
data to any third party other than:
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their
respective AFFILIATED COMPANIES; or
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a
third party solely to the extent necessary for furthering the
purposes of this AGREEMENT, provided that the third party agrees in
writing to maintain the confidentiality of the CONFIDENTIAL
INFORMATION in a manner consistent with the confidentiality
provisions of this AGREEMENT; or
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in
connection with seeking MARKETING AUTHORIZATIONS outside the
TERRITORY.
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Notwithstanding
the foregoing, each party may disclose CONFIDENTIAL INFORMATION to
any AGENCY to the extent that such disclosure (i) is necessary for
the purposes of this AGREEMENT and/or (ii) is legally
required.
The
party receiving CONFIDENTIAL INFORMATION (the “RECEIVING
PARTY”) may do so only if it limits disclosure to that
purpose, after giving the party disclosing CONFIDENTIAL INFORMATION
(the “DISCLOSING PARTY”) prompt written notice of any
instance of such a requirement in reasonable time for the
DISCLOSING PARTY to take steps to object to or to limit such
disclosure. In the event of disclosures required by law,
the RECEIVING PARTY shall cooperate with the DISCLOSING PARTY as
reasonably requested thereby.
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The
secrecy obligations herein shall last during and for a period of
five (5) years, and ten (10) years with respect to KNOW-HOW, after
any termination of this AGREEMENT, subject to the exceptions set
forth herein. The obligations of confidentiality and use
of information and data above shall not apply with regard to that
information and those data which:
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the
RECEIVING PARTY can show in writing were known to it or to its
AFFILIATES at the time of disclosure, and/or
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are
public knowledge at the time of disclosure to the RECEIVING PARTY,
and/or
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become
public knowledge at a later date without any fault of the RECEIVING
PARTY, and/or
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are
independently developed by the RECEIVING PARTY or its AFFILIATES,
as competently proven.
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DOR
and STPI agree that they shall refer any serious adverse event or
significant clinical safety information which they have knowledge
thereof to the other party according to the procedure to be agreed
upon separately and documented in the PHARMACOVIGILANCE
AGREEMENT.
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Any
proposed written publications of a party relating to PRODUCT and AG
PRODUCT shall be cleared for release by the other
party. The disclosing party shall provide a copy of the
proposed written publication to the reviewing party at least thirty
(30) days prior to the intended date of release. The reviewing
party shall have thirty (30) days from receipt of the proposed
written publication to provide comments and/or proposed changes to
the disclosing party. These timelines will be reduced to
respectively ten (10) and five (5) working days in the case of
abstracts. In the event the disclosing party does not accept the
comments and/or proposed changes, DOR and STPI shall further
discuss, and mutually agree upon, the final wording of the written
publication. Thereby, due regard shall be given to the receiving
party’s legitimate interests, e.g. , obtaining optimal
patent protection, coordinating and maintaining the proprietary
nature of submissions to AGENCIES, and protection of confidential
data and information. The review period may be extended for an
additional two (2) months to permit the reviewing party to file one
or more patent applications as it deems appropriate. While
publications and presentations by outside investigators may be
difficult to control, both STPI and DOR shall use reasonable
efforts to gain the right to review publications and presentations
relating to the PRODUCT and AG PRODUCT by such outside
investigators. This Article 3.6 shall not apply to disclosures to
the financial community, including investor conferences and
analysts’ meetings/reports, provided that such disclosure
does not undermine the validity of any claims in a prospective
patent application.
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JOINT
DEVELOPMENT COMMITTEE
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As
soon as possible after the EFFECTIVE DATE, DOR and STPI shall
appoint a JOINT DEVELOPMENT COMMITTEE in which both parties are
equally represented by three (3) members designated by each party.
A party may change one or more of its representatives to the JOINT
DEVELOPMENT COMMITTEE at any time. The Chairman of the
JOINT DEVELOPMENT COMMITTEE shall be a representative appointed by
DOR.
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Meetings
of the JOINT DEVELOPMENT COMMITTEE shall be held at locations
designated by the parties approximately every three (3) months or
as the JOINT DEVELOPMENT COMMITTEE may deem necessary. At these
meetings, progress of the work over the preceding period shall be
discussed and the parties will discuss, formulate and agree to
plans, including plans and strategy for the regulatory dossiers, to
achieve the goals of the collaboration. Also, at these
meetings DOR will supply STPI with progress reports summarizing any
and all clinical, technical and manufacturing activities conducted
over the prior three-month period. At these meetings either party
shall be entitled to ask and to receive from the other party any
detail on any and all aspects of the activities performed by the
other party. The Chairman shall prepare or have prepared the
minutes reporting in reasonable detail the actions taken by the
JOINT DEVELOPMENT COMMITTEE, the issues requiring resolution and
resolutions of previously reported issues, which minutes are to be
signed by a representative of each party, promptly after each
meeting. In the first meeting of the JOINT DEVELOPMENT COMMITTEE
the parties shall discuss and agree upon a common policy to be used
in answering any inquiries from and/or in making any communications
to any AGENCY in the TERRITORY.
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Any
decision by the JOINT DEVELOPMENT COMMITTEE shall be taken on a
consensus basis, by the majority of the elected members. In the
event the JOINT DEVELOPMENT COMMITTEE is unable to reach a decision
by consensus, the matter(s) in dispute shall be referred to an
executive committee (hereinafter “EXECUTIVE COMMITTEE”)
for decision. The EXECUTIVE COMMITTEE shall consist of the
President of STPI (or its designee) and the President of DOR (or
its designee), provided however any final determination shall be
made by DOR.
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DOR
shall use DILIGENT EFFORTS to carry out development of the PRODUCT
in accordance with the DEVELOPMENT PLAN. If DOR
determines that it will be unable to accomplish any of the key
clinical events identified in the DEVELOPMENT PLAN, it shall
promptly notify the JOINT DEVELOPMENT COMMITTEE at the next
regularly scheduled meeting, and if necessary, DOR shall develop a
revised DEVELOPMENT PLAN for the PRODUCT, to be agreed upon in good
faith between the parties.
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Each
party shall bear all expenses of its representatives related to
their participation in the JOINT DEVELOPMENT COMMITTEE.
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DOR
shall use DILIGENT EFFORTS in connection with, and shall be
responsible for conducting or having conducted through a Contract
Research Organization, the development of the PRODUCT according to
the DEVELOPMENT PLAN, at DOR’s sole costs and expenses, which
development includes the completion of the PHASE 3 TRIAL and the
assemblage of the registration dossier so that the MARKETING
AUTHORIZATIONS can be filed by DOR with the competent AGENCY in the
TERRITORY.
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It is
expected that the PRODUCT development will be related first to the
use of the PRODUCT in the treatment of GI GVHD. If either DOR
or STPI determines that additional development may yield new
indications for PRODUCT, the parties agree to negotiate in good
faith, without obligation, the potential for a sharing of costs,
milestones, or any other mutually acceptable arrangement that would
encourage such development. In the event the parties reach an
agreement, this AGREEMENT would be amended in writing
accordingly.
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DOR
agrees to supply, free of charge, the PRODUCT necessary to conduct
the PHASE 3 TRIAL as well as any clinical trial as approved by the
JOINT DEVELOPMENT COMMITTEE in order to pursue the fullest
development. Any PRODUCT required for any
Phase 4 studies that are required by or negotiated with the FDA as
a condition to obtaining or maintaining APPROVAL of the PRODUCT
shall be supplied by DOR free of charge. Any PRODUCT
required for any Phase 4 studies requested by STPI that are not
required by or negotiated with the FDA as a condition to obtaining
or maintaining APPROVAL of the PRODUCT shall be supplied by DOR at
DOR’s FULLY BURDENED COST.
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DOR
shall promptly supply STPI with the results of the PHASE 3 TRIAL as
well as with any and all results and documentation arising from any
studies conducted by DOR. DOR grants STPI the right to use these
results and documentation for COMMERCIALIZATION and
pharmacovigilance purposes for the PRODUCT in the FIELD in the
TERRITORY.
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As
supplier of the PRODUCT and AG PRODUCT, DOR shall be responsible
for filing or having applicable vendors/suppliers file drug master
files with respect to the SUBSTANCE and PRODUCT with all relevant
AGENCIES in the TERRITORY in accordance with the DEVELOPMENT
PLAN.
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The
parties shall cooperate in good faith with respect to the conduct
of any inspections by an AGENCY of a party’s site and
facilities related to the PRODUCT and AG PRODUCT. To the
extent either party receives any material written or oral
communication from an AGENCY relating to the APPROVAL process with
respect to the PRODUCT in the TERRITORY, the party receiving such
communication shall promptly notify the other party and provide a
copy of such written communication and/or a written summary of such
oral communication as soon as reasonably
practicable. The parties shall cooperate in good faith
with respect to all regulatory filings required under this
AGREEMENT.
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DOR
acknowledges that certain PRODUCT-related activities undertaken by
DOR outside of the TERRITORY may trigger material reporting
obligations to an AGENCY and may materially affect the
COMMERCIALIZATION of the PRODUCT by STPI in the TERRITORY, and with
respect to such activities that DOR determines in good faith are
likely to trigger such material reporting obligations and/or are
likely to materially affect such COMMERCIALIZATION by STPI, DOR
shall disclose such PRODUCT-related activities outside of the
TERRITORY to STPI and permit STPI to promptly review them and
provide comments and suggestions that would enable both parties to
achieve their objectives under this
AGREEMENT. Similarly, STPI shall disclose any
PRODUCT-related activities within the TERRITORY to DOR and permit
DOR to promptly review them and provide comments and suggestions
that would enable both parties to achieve their objectives under
this AGREEMENT. If the parties are unable to reach
mutual agreement regarding a fair and reasonable approach that
would avoid or minimize any material reporting obligations and
material effects on COMMERCIALIZATION of the PRODUCT by STPI, such
dispute or disagreement shall be resolved pursuant to Article
17.
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DOR
shall conduct any post-APPROVAL development programs for the
PRODUCT in the TERRITORY, including Phase 4 studies, that are
required by or negotiated with the FDA as a condition to obtaining
or maintaining APPROVAL of the PRODUCT. The cost and
expense of any such programs related to treatment of GI GVHD shall
be borne by DOR. The cost and expense of any Phase 4
studies requested by STPI that are not required by or negotiated
with the FDA as a condition to obtaining or maintaining APPROVAL of
the PRODUCT shall be borne by STPI.
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REGISTRATION,
COMMERCIALIZATION.
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DOR
will own the NDA or submission filed by DOR with any AGENCY to
obtain the MARKETING AUTHORIZATIONS in any country of the
TERRITORY. DOR will also own all MARKETING
AUTHORIZATIONS.
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DOR
shall file applications for and maintain MARKETING AUTHORIZATIONS
for the PRODUCT in the FIELD in the TERRITORY with the competent
AGENCY in the TERRITORY in DOR’s own name and costs. DOR
shall at its own cost and expense obtain and comply with all
authorizations, licenses, permits and regulations which may from
time to time be required from any AGENCY in the TERRITORY to enable
DOR to obtain and maintain MARKETING AUTHORIZATIONS.
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DOR,
directly and/or through the manufacturer/s of the PRODUCT and AG
PRODUCT, and STPI will enter into the QUALITY ASSURANCE AGREEMENT,
which will set forth in detail the responsibilities of the parties
concerning manufacturing, control, and release of the PRODUCT and
AG PRODUCT. The QUALITY ASSURANCE AGREEMENT will also
address, but not be limited to, preliminary specifications, raw
material purchasing and controls, analytical documentation, costs
of quality assurance and other matters relating to compliance with
cGMP in the TERRITORY.
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STPI
shall be responsible for the promotion, marketing and distribution
of the PRODUCT and AG PRODUCT in the FIELD in the TERRITORY, and
the creation, if any, of associated marketing collaterals, inserts,
advisory information or material or the like.
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Joint
Commercialization Committee .
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Promptly
after the EFFECTIVE DATE, the parties shall appoint a JOINT
COMMERCIALIZATION COMMITTEE in which both parties are equally
represented by three (3) members designated by each party. A party
may change one or more of its representatives to the JOINT
COMMERCIALIZATION COMMITTEE at any time. The Chairman of
the JOINT COMMERCIALIZATION COMMITTEE shall be a representative
appointed by STPI.
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Any
decision by the JOINT COMMERCIALIZATION COMMITTEE shall be taken on
a consensus basis, by the majority of the elected members. In the
event the JOINT COMMERCIALIZATION COMMITTEE is unable to reach a
decision by consensus, the matter(s) in dispute shall be referred
to the EXECUTIVE COMMITTEE for decision, provided however any final
determination shall be made by STPI.
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Meetings
of the JOINT COMMERCIALIZATION COMMITTEE shall be held at locations
designated by the parties approximately every three (3) months; via
teleconferencing or as the JOINT COMMERCIALIZATION COMMITTEE may
deem necessary. In furtherance of its responsibility for
overseeing the COMMERCIALIZATION of the PRODUCT, the JOINT
COMMERCIALIZATION COMMITTEE shall perform the following
activities:
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review
strategy for COMMERCIALIZATION of PRODUCT, including product
positioning;
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coordinate
with the JOINT DEVELOPMENT COMMITTEE as appropriate;
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review
and comment on marketing plans;
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facilitate
the flow of information with respect to the COMMERCIALIZATION of
the PRODUCT and AG PRODUCT;
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coordinate
plans for labeling and selecting TRADEMARKS for PRODUCT and AG
PRODUCT in the TERRITORY;
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review
and comment on advertising and promotional materials, including
medical education, symposia, opinion leader development,
peer-to-peer development, publications and journal ads;
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design,
in collaboration with the JOINT DEVELOPMENT COMMITTEE, Phase 4
studies, and review use and dissemination of such resulting
data;
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review
and comment on final packaging, and plan and oversee educational
and professional symposia and speaker and peer-to-peer activity
programs;
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recommend
to the JOINT DEVELOPMENT COMMITTEE whether to seek NEW INDICATIONS,
formulations or uses for the PRODUCT and AG PRODUCT, such as for
PRODUCT and AG PRODUCT life cycle management;
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work
with the JOINT DEVELOPMENT COMMITTEE for approval of early access
and compassionate use programs.
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On or
before the filing of the NDA for a PRODUCT in the FIELD in the
TERRITORY, the JOINT COMMERCIALIZATION COMMITTEE shall prepare and
approve a detail marketing plan which shall set forth market
development activities and expenditures by STPI and the steps that
will be taken in order to COMMERCIALIZE the PRODUCT.
Following the APPROVAL, the parties shall communicate regularly in
order to review the activities taken in connection with the
COMMERCIALIZATION of the PRODUCT in the TERRITORY.
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STPI
shall at all times use DILIGENT EFFORTS in the COMMERCIALIZATION in
the TERRITORY of the PRODUCT and AG PRODUCT.
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Each
party shall bear all expenses of its representatives related to
their participation in the JOINT COMMERCIALIZATION
COMMITTEE.
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STPI
agrees that the TRADEMARK shall be owned, controlled and maintained
(including filing, watching, renewals) by DOR, at DOR’s sole
costs and expenses, for the duration of this AGREEMENT.
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DOR
agrees to take promptly all reasonable legal action necessary to
protect the TRADEMARK against any infringement by third parties. If
within sixty (60) days following notice of a possible infringement
of the TRADEMARK, DOR decides not to take action to restrain such
infringement, STPI shall, in its sole discretion, have the right to
take such action as it deemed necessary or desirable. Each party
agrees to render such reasonable assistance the other party may
reasonably request (e.g. necessary Powers of Attorney). Costs of
any action brought by either party here under and recovery achieved
as a result thereof, shall belong to DOR.
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Should
any settlement or judicial finding which is reviewable by a higher
authority arise as a result of such action, then STPI and DOR shall
reasonably consult before accepting any settlement or judicial
finding which is reviewable by a higher authority.
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STPI
agrees to comply with the trademark usage standards attached to
this AGREEMENT as Appendix D. From time to time, or upon
the request of DOR, STPI agrees to supply DOR with a sample of
advertisements, marketing material and the promotional material
bearing the TRADEMARKS prior to their use for the purpose of
enabling DOR to have thirty (30) days to examine and approve the
foregoing.
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MANUFACTURING
AND SUPPLY OF THE PRODUCT
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In
order to ensure that the manufacture of the PRODUCT and AG PRODUCT
conforms to the highest quality standards: (i) STPI undertakes to
purchase all its requirements of the PRODUCT and AG PRODUCT from
DOR at the SUPPLY PRICE set forth in Appendix C to this AGREEMENT;
and (ii) DOR undertakes to manufacture and supply STPI with all
STPI’s requirements of the PRODUCT and AG PRODUCT.
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Forecasts
. In
order to assist DOR in its production planning, STPI shall submit
to DOR as soon as possible before the launching of the PRODUCT and
AG PRODUCT by STPI, its best estimates of its purchase requirements
of PRODUCT and AG PRODUCT for the first twelve (12) months,
together with projected delivery dates. Thereafter, not
later than the
10
th
working
day of each calendar month, STPI shall submit to DOR its best
estimates of its purchase requirements (“ESTIMATED
QUANTITIES”) and delivery dates of PRODUCT and AG PRODUCT for
the following twelve (12) calendar months, broken down into
requirements for each calendar month.
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Firm
Orders . Not
less than ninety (90) calendar days prior to the beginning of each
calendar month, STPI shall submit to DOR a binding purchase order
for its requirements of PRODUCT and AG PRODUCT in such month
(“FIRM ORDER”). The quantity in each
FIRM ORDER for PRODUCT and AG PRODUCT shall not be less than
seventy-five percent (75%) nor more than one hundred twenty-five
percent (125%) of the ESTIMATED QUANTITY for such PRODUCT and AG
PRODUCT for any calendar month as most recently
updated. Notwithstanding the foregoing, DOR shall use
DILIGENT EFFORTS to fill requested revisions of FIRM ORDERS that
are in excess of one hundred twenty-five percent (125%) of the
ESTIMATED QUANTITY. DOR shall deliver the PRODUCT and AG
PRODUCT at the requested delivery dates set forth in the FIRM
ORDER, which dates shall have been agreed upon by the parties in
advance as commercially reasonable.
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Delivery
. DOR
shall deliver or arrange for the delivery of PRODUCT and AG PRODUCT
ordered by STPI CIP (ICC Incoterms 2000) to STPI’s warehouses
in the U.S. DOR shall provide STPI with certificates of
analysis related to the PRODUCT and AG PRODUCT for each batch
released for delivery hereunder. These certificates will
document that each batch received by STPI conforms to the agreed
upon specifications and is otherwise in conformity with Article
8.6. A copy of each certificate shall be included with
each batch delivered to STPI.
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At
STPI’s expense, DOR shall allow STPI’s employees,
consultants or other representatives upon prior written
notification, at all reasonable business times, to visit and
inspect the premise(s) used directly or indirectly by DOR or its
subcontractors or AFFILIATES for the manufacturing (e.g.
processing, packing, etc.) of the SUBSTANCE, PRODUCT and/or AG
PRODUCT, but in any event not more than once annually unless DOR
has received a warning letter from the FDA and then such visits may
be conducted more frequently as reasonably necessary to provide
assurances to STPI until the defects listed in such warning letter
are remedied. STPI warrants that all such inspections
and audits shall be carried out in a manner so as not to
unreasonably interfere with DOR’s, its subcontractors’
or its AFFILIATES’ conduct of business and to insure the
continued confidentiality of DOR’s business and technical
information. Further, STPI agrees to comply with all of
DOR’s safety and security requirements during any visits to
the DOR, its subcontractors’, or AFFILIATES’
facilities. STPI agrees to make promptly available to
DOR any external reports from such facility visit(s).
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DOR
represents and warrants that the PRODUCT and AG PRODUCT
manufactured by or on behalf of DOR shall (i) meet the
specifications set forth in the registration dossier and MARKETING
AUTHORIZATIONS and (ii) be manufactured and packaged in compliance
with applicable law, including cGMP. DOR will be
responsible for labeling and packaging of PRODUCT and AG PRODUCT
for final distribution, utilizing TRADEMARKS and artwork provided
by STPI to DOR in accordance with the terms hereof. Any
claim under this representation and warranty shall be governed by
Article 8.8. The provisions of this Article 8.6 shall
not in any way limit DOR’s indemnification obligations under
Article 13.2.
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The
SUPPLY PRICE for the PRODUCT and AG PRODUCT supplied and delivered
to STPI in accordance with this AGREEMENT shall be paid to DOR in
accordance with the provisions of Appendix C hereof.
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Claims
. All
claims made concerning quality, loss or other defects in any
PRODUCT must be made to DOR in writing within thirty (30) days
following delivery of the PRODUCT and AG PRODUCT to STPI;
provided , however , that other than with respect to
defects or other non-compliance plainly observable from a visual
inspection, any acceptance or deemed acceptance shall not adversely
affect or otherwise diminish STPI’s rights to receive
shipments of the PRODUCT and AG PRODUCT in compliance with the
requirements of Article 8.6 or its rights in respect of Article
13. At DOR’s request, STPI shall forward for
inspection a representative sampling of the PRODUCT and AG PRODUCT
or any part thereof that is the subject of STPI’s
claim. DOR shall inspect such samples and, if it concurs
with STPI’s claim, shall promptly replace the defective
PRODUCT and AG PRODUCT without any cost to STPI. If the
parties are unable to resolve their differences within sixty (60)
days of STPI’s claim, then either party may refer the matter
to an independent specialized firm of international reputation
agreeable to both the parties for final analysis, which shall be a
final resolution of such issue, binding on both parties hereto. If
the PRODUCT and AG PRODUCT is determined to be in compliance or if
there is a nonconformity with respect to such PRODUCT and AG
PRODUCT but the nonconformity occurred after delivery by DOR, then
STPI shall bear the cost of the independent laboratory testing and
pay for the PRODUCT and AG PRODUCT in accordance with this
AGREEMENT and DOR shall have no liability. If the
PRODUCT and AG PRODUCT is determined not to be in compliance, then
DOR shall bear the cost of independent laboratory testing, and
shall, at its election, either replace the rejected PRODUCT and AG
PRODUCT at no cost to STPI, or credit STPI for the SUPPLY PRICE
paid by STPI with respect to the defective PRODUCT and AG PRODUCT.
STPI shall provide prompt assistance to DOR in connection with any
recall including without limitation notification of the customers
and recalling the PRODUCT and AG PRODUCT supplied to such
customers, at DOR’s cost. Each party shall act in
good faith and shall cooperate with the other party, with any
qualified independent third-party laboratory in connection with an
investigation, and with the arbitrator, as to the existence of or
source of nonconformity with respect to a batch of PRODUCT and AG
PRODUCT supplied under this AGREEMENT. In testing the
batch of PRODUCT and AG PRODUCT, any independent third-party
laboratory shall use analytical testing methods as agreed upon by
the parties. This shall be the sole remedy for the resolution of
any claims STPI or its AFFILIATES related to any defective or non
conforming PRODUCT. The provisions of this Article 8.8
shall not in any way limit DOR’s indemnification obligations
under Article 13.2.
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DOR
undertakes to appoint at least one back up manufacturer. Should DOR
expect to be unable, directly or indirectly, to timely and
accurately supply STPI with STPI’s total requirement of the
PRODUCT and AG PRODUCT, it will promptly inform STPI in advance and
the parties will promptly convene to agree in good faith how best
to proceed, including using alternate manufacturer/s to fulfill
DOR’s obligation to supply PRODUCT and AG PRODUCT. This
Article 8.9 is without prejudice for STPI to claim any and all
damages resulting from DOR’s inability to timely and
accurately fulfill its obligation to supply STPI with all
STPI’s requirements of the PRODUCT and AG PRODUCT in the
TERRITORY.
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OTHER
THAN AS SET FORTH IN THIS AGREEMENT, ALL OTHER WARRANTIES OF EITHER
PARTY, BOTH EXPRESS AND IMPLIED, ARE HEREBY EXPRESSLY DISCLAIMED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OF THE DRUG SUBSTANCE OR THE SERVICES PROVIDED
HEREUNDER. IN NO EVENT SHALL DOR OR STPI BE LIABLE FOR
CONSEQUENTIAL DAMAGES, INCIDENTAL DAMAGES, LOST PROFITS, LOST
PRODUCTS, PUNITIVE DAMAGES OR LOSS OF OPPORTUNITY.
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DOR
shall maintain true and accurate books, records, test and
laboratory data, reports and all other information relating to
manufacturing and packaging under this AGREEMENT, including all
information required to be maintained by the specifications and all
applicable laws. Such information shall be maintained in
forms, notebooks and records for a period as required under
applicable laws and/or as outlined in the QUALITY ASSURANCE
AGREEMENT.
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(The
information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately
filed with the Commission.)
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STPI
shall pay to DOR the following amounts plus VAT, if
applicable:
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one
million U.S. Dollars (U.S. $1,000,000) to be paid within thirty
(30) days of receipt of a report, certified by DOR, stating that
the first patient in the PHASE 3 TRIAL has been administered the
PRODUCT; and
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*****
to be paid within thirty (30) days of receipt of a report from DOR
showing that the PHASE 3 TRIAL has successfully achieved its
primary endpoint consistent with the FDA’s Special Protocol
Assessment (SPA) feedback in support of an NDA; and
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*****
to be paid within thirty (30) days upon the cumulative NET
SALES in the TERRITORY having achieved twenty-five million U.S.
Dollars (U.S. $25,000,000); and
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***** to
be paid within thirty (30) days upon the NET SALES in the TERRITORY
for any twelve (12) month period (i.e., any twelve (12) consecutive
months) exceeding fifty million U.S. Dollars (U.S.
$50,000,000).
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For
the avoidance of doubt, (i) each of the above milestones will be
payable only once for each event described and (ii) the aggregate
of all milestone payments under this Article 9.1 during the
term of this AGREEMENT shall not exceed an amount equal to ten
million U.S. Dollars (U.S. $10,000,000).
The
above milestones payments are to be considered STPI’s
contribution to and reimbursement of the costs and expenses related
to the PHASE 3 TRIAL and other activities necessary to obtain and
maintain the MARKETING AUTHORIZATIONS. Accordingly, DOR undertakes
to utilize such milestones payments received prior to the granting
of the MARKETING AUTHORIZATIONS only for the furtherance of the
PHASE 3 TRIAL and other PRODUCT development activities necessary to
obtain and maintain the MARKETING AUTHORIZATIONS in the TERRITORY;
DOR shall send to STPI quarterly reports showing the proper
allocation of the above milestones payments.
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STPI
shall pay DOR a certain SUPPLY PRICE, starting from the FIRST
COMMERCIAL SALE of the PRODUCT and AG PRODUCT by STPI during the
term of this AGREEMENT, as specified by the provisions of Appendix
C attached hereto.
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Upon
the ninety (90) days prior to the date where DOR will be required
to supply PRODUCT to STPI, DOR shall inform STPI of the amount of
the FIXED COMPONENT of the SUPPLY PRICE. DOR shall
reasonably cooperate with any request by STPI to review DOR’s
determination of the FIXED COMPONENT, but barring any clear error
in calculation, the determination of DOR shall be
conclusive. DOR shall inform STPI of any adjustment to
the FIXED COMPONENT at least thirty (30) days prior to making such
adjustment. DOR shall reasonably cooperate with any
request by STPI to review DOR’s determination of the
adjustment to FIXED COMPONENT, but barring any clear error in
calculation, the determination of DOR shall be conclusive and
STPI.
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STPI
shall keep accurate books and records setting forth the sales in
unit and value, the selling prices, the NET SALES and the amount of
SUPPLY PRICE payable to DOR hereunder, for each country of the
TERRITORY with regard to the PRODUCT and AG PRODUCT sold. DOR, at
its discretion, shall be permitted either: to have performed by an
independent certified public accounting firm of nationally
recognized standing selected by DOR and reasonably acceptable to
STPI, at DOR’s expense, yearly audits of STPI records and
books related to the PRODUCT and AG PRODUCT, provided such audits
are reasonably conducted at STPI convenience and during STPI
regular business hours. DOR’s representative or
agent will be required to execute a reasonable and commercially
customary confidentiality agreement with STPI prior to commencing
any audit. Such auditor shall report to DOR only on the accuracy of
the information provided by STPI (without taking any copies of STPI
records and books) and whether additional amounts are
owed. Such audits may be conducted for any calendar year
ending not more than twenty-four (24) months prior to the date of
each request. The right to audit with respect to any calendar year
shall terminate three (3) years after the end of any such calendar
year. In the event that a discrepancy arises between the SUPPLY
PRICE paid to DOR and STPI records and books, STPI shall be given
thirty (30) days from the receipt of the notice to either
explain such discrepancy and/or remedy such discrepancy, as
appropriate. Further, in the event of a discrepancy of
more than five percent (5%) between the amount owed and the
actual amount received by DOR, STPI shall reimburse all the actual
expenses and costs incurred by DOR in performing such
audit.
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The
obligation to pay SUPPLY PRICE hereunder shall be imposed only once
with respect to each unit of the PRODUCT and AG
PRODUCT. No payments shall accrue on the sales of STPI
to its AFFILIATED COMPANIES or sublicensees (if permitted) or
distributors or agents as well as on any transactions between such
entities. Payments shall accrue only on sales to
unrelated third parties in arm’s length
transactions.
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Any
taxes (other than value added or income taxes) STPI is
required by the local authorities to pay or withhold on behalf of
DOR with respect to the money payable to DOR under this AGREEMENT
shall be deducted from the amount of such payments, provided
, however , that with regard to any such deduction STPI
shall give DOR such assistance as may be necessary to enable or
assist DOR to claim exception therefore (under US or other
applicable laws as well as any applicable treaties or conventions)
and shall give DOR proper evidence as to payment of the
tax. Any other taxes due in the TERRITORY and arising
out of or in connection with STPI exercise of the rights granted
herein shall be borne by STPI. STPI shall not be
responsible for paying DOR’s income tax.
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(The
information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately
filed with the Commission.)
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In
the event of GENERIC COMPETITION in any country of the TERRITORY,
the SUPPLY PRICE due in said country pursuant to Appendix C hereof
shall be reduced (and may be subsequently increased, not to exceed
the SUPPLY PRICE agreed to as of the date hereof) from time to time
by the same percentage of the decrease (and may be subsequently
increased, not to exceed the SUPPLY PRICE agreed to as of the date
hereof) in the NET SALES during any three (3) month
rolling period, provided , however , that in no event
shall the SUPPLY PRICE be reduced to below ***** of the FULLY
BURDENED MANUFACTURING COST. Such reduction/s shall
commence with the beginning of the next month following
STPI’s written notification to DOR.
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In
the event it is necessary due to the claim of a third party or a
court order to obtain a license from any unaffiliated third party
under any patent or other intellectual property right having claims
that the APPROVED PRODUCT that is currently subject to the PHASE 3
TRIAL or its use, sale or manufacture infringes, DOR shall have the
sole and exclusive right to negotiate a license to such third party
intellectual property. If after six (6) months (or one
(1) month if there is an injunction in place), DOR is unable to
secure a license or other settlement, then STPI shall have the
right to secure such a license or obtain other settlement provided
that such terms are commercially reasonable within the applicable
industry. In the event that STPI is obligated to pay a
royalty due to such infringement to such unaffiliated third party
or parties in any country in order to COMMERCIALIZE
the APPROVED PRODUCT in the TERRITORY in the FIELD, then STPI shall
have the right to deduct the amount of such royalties which STPI
pays to such unaffiliated party or parties for such product, in
such country in a calendar quarter, from the PERCENTAGE COMPONENT
of the SUPPLY PRICE to be paid to DOR as set forth in Appendix C
for such PRODUCT in such country in a calendar quarter;
provided , however , that in no event shall the
PERCENTAGE COMPONENT of the SUPPLY PRICE for any PRODUCT payable
hereunder to DOR be less than fifty percent (50%) of the amounts
payable to DOR pursuant to Appendix C immediately prior to the
initiation of STPI’s obligation to pay such third party
royalty. This provision shall also apply to any other
APPROVED PRODUCT which is mutually agreed by the parties to be
COMMERCIALIZED by STPI.
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Without
limiting the generality of the foregoing, DOR shall remain
responsible for any royalty obligations due to third parties under
the PATENT RIGHTS and/or the KNOW-HOW and/or the TRADEMARK which
have been licensed to STPI hereunder. DOR will not be entitled to
add such royalties due to third parties to the SUPPLY
PRICE.
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For
the entire term of this AGREEMENT, DOR shall prosecute and maintain
the PATENT RIGHTS at its own expense.
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Each
party shall advise the other promptly upon its becoming aware of
any third party infringement of the PATENT RIGHTS. After discussing
its intentions with STPI, DOR may at its option take such action as
is required to restrain such infringement, STPI having the right to
cooperate in its attempt to restrain such infringement. STPI may be
represented by counsel of its own choice, at its own expense at any
suit or proceeding brought to restrain such infringement. If,
however, within forty-five (45) days of the notice of a third party
infringement, DOR fails to institute an infringement suit that STPI
feels is reasonably required, STPI shall have the right at its own
discretion to institute an action for infringement of any of the
claim or claims of the PATENT RIGHTS in
question and DOR agrees to use DILIGENT EFFORTS under the MCDONALD
LICENSE to protect STPI’s rights set forth herein. After
MCDONALD has been paid any and all amounts owed under Section 9 of
the MCDONALD LICENSE, to the extent applicable, and after both
parties have been reimbursed for their expenses in bringing such
suit or proceeding, any further recovery obtained as a result of
such action, whether by judgment, award, decree or settlement,
shall be split as follows: (i) if DOR brings the action, then DOR
retains 65% and STPI retains 35% and (ii) if STPI brings the
action, then DOR retains 35% and STPI retains 65%.
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Should
any settlement or judicial finding which is reviewable by a higher
authority arise as a result of such action, then STPI and DOR shall
reasonably consult before accepting any settlement or judicial
finding which is reviewable by a higher authority.
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MCDONALD
has certain rights to participate in any action for infringement
and other rights as set forth in Section 9 of the MCDONALD LICENSE
and to the extent applicable, the rights of the parties in respect
thereof are subject to such rights of MCDONALD as set
forth
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