PRODUCT DEVELOPMENT, LICENCE AND COMMERCIALIZATION AGREEMENT
Exhibit 6.1
This
Product Development, Licence and Commercialization Agreement
(“Agreement”) is made and entered into as of February
27th,
2015 by and between Daewoong Pharmaceuticals Co.
Ltd. a company incorporated under the laws of South Korea
and having its registered office at 000-0, Xxxxxxx-Xxxx,
Xxxxxxx-Xx, Xxxxx, Xxxxx (“DAEWOONG”) and
Autotelic, LLC and
Autotelic, Inc., and Stocosil Inc. (“STOCOSIL”)
companies incorporated under the laws of Delaware, having its
registered office at 00000 Xxxxxxxxx Xxxxxx, Xxx. 000, Xxxx xx
Xxxxxxxx, XX 00000, XXX. (“STOCOSIL”).
STOCOSIL
will be the main party to this Agreeemnt, and Autotelic, LLC
together with Autotelic, Inc., (“AUTOTELIC”)
will be the secondary parties to this Agreement and the
“Sponsor” (to be defined below in the Definition
Clause) of STOCOSIL. As the Sponsor of STOCOSIL, AUTOTELIC will
assume all the responsibilities, obligations, and liabilities of
STOCOSIL until STOCOSIL successfully raises $5 million in equity
and additional $15 million ($20 million in total) in
equity. Once STOCOSIL successfully raises $5 million in
equity, Autotelic, LLC will no longer be the secondary party to
this Agreement and Sponsor of STOCOSIL. Further, when
STOCOSIL successfully raises additional $15 million ($20 million in
total), Autotelic, Inc. will no longer be the secondary party to
this Agreement and Sponsor of STOCOSIL. To avoid any
doubt, Autotelic, LLC will be relieved of any of responsibilities,
obligations, and liabilities under this Agreement once STOCOSIL
successfully raises $5 million in equity. Further,
Autotelic, Inc. will be relieved of any of responsibilities,
obligations, and liabilities under this Agreement once STOCOSIL
successfully raises additional $15 million ($20 million in total)
in equity. However, the Clause 7, Non-Compete, and
Clause 11, Confidentiality and Publication, will be continuously
effective for AUTOTELIC even after AUTOTELIC ceases to be the party
to this Agreement as long as this Agreement is in effect and not
formally terminated.
In
the event of Change in ownership or effective control of STOCOSIL,
this Agreement shall remain in full force and effective with the
acquirer or successor of STOCOSIL.
DAEWOONG
and STOCOSIL are herein referred to each as a “Party”
and, collectively, as the “Parties”.
WHEREAS:
I.
DAEWOONG
and its Affiliates (as defined below) control certain intellectual
property and other rights in and to the Products and DAEWOONG
Existing Product (as defined below).
II.
AUTOTELIC,
STOCOSIL and its Affiliates (as defined below) have extensive
experience in the discovery, developing and commercialization of
pharmaceutical products in the USA.
III.
STOCOSIL
desires to Develop and Commercialize (as defined below) Products
(as defined below) in the Territory (as defined
below).
IV.
The
Parties desire to Develop and Commercialize the Products (as
defined below) pursuant to the terms and conditions of this
Agreement.
NOW, THEREFORE, in consideration of the covenants and
obligations expressed herein, the Parties hereto, intending to be
legally bound, do hereby agree as follows:
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1.
DEFINITIONS AND INTERPRETATION
1.1 The
following terms shall have the following meanings when used in this
Agreement:
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“Activ “Pharmaceutical
Ingredient” or “API”
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means
in respect of the Product the active substance(s) contained in that
Product.
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“Adverse Event”
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shall
have the meaning as defined in Safety Data Exchange
Agreement.
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“Affiliates”
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means,
in relation to a Party, any person, which directly or
indirectly through one or more intermediaries controls, is
controlled by or is under common control with such
Party. An entity shall be deemed to control another
entity if it: (i) owns, directly or indirectly, at least
fifty percent (50%) of the outstanding voting securities or capital
stock (or such lesser percentage which is the maximum allowed to be
owned by a foreign corporation in a particular jurisdiction) of
such other entity, or has other comparable ownership interest with
respect to any entity other than a corporation; or (ii) has the
power, whether pursuant to contract, ownership of securities or
otherwise, to direct the management and policies of the
entity. Further, they also mean that any companies
whose, at least 50%, shareholders are also the shareholders of
either of the Parties at the time of the inception of these
companies, defined as “Common Control”.
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“Agreement”
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means
this agreement, together with its Schedules, as amended from time
to time by the Parties.
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“Applicable Law”
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means
any domestic or foreign statute, law, ordinance, rule,
administrative interpretation, regulation, order, writ, injunction,
directive, judgment, decree or other requirement of any Regulatory
Authority applicable to a Party or its properties, business, assets
or a Product or any of the activities contemplated hereunder that
may be in effect from time to time.
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“Business Day”
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means
a day other than a Saturday or a Sunday when the banks in Los
Angeles and Korea are open for normal business.
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“Calendar Quarter”
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means
each successive period of three (3) consecutive calendar months
commencing on January 1, April 1, July 1 and October 1, except that
the first Calendar Quarter of the Term shall commence on the
Effective Date and end on the day immediately prior to the first to
occur of January 1, April 1, July 1 or October 1 after the
Effective Date, and the last Calendar Quarter shall end on the last
day of the Term.
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“Calendar
Year”
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means
each successive period of twelve (12) consecutive calendar months
commencing on January 1 and ending on December 31, except that the
first Calendar Year of the Term shall commence on the Effective
Date and end on December 31 of the year in which the Effective Date
occurs and the last Calendar Year of the Term shall commence on
January 1 of the year in which the Term ends and end on the last
day of the Term.
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“Claim”
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means
Third Party suits, claims, actions, proceedings or
demands.
i
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“Clinical Trials”
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means
Phase I, Phase II, Phase III, Phase IV or such other tests and
studies in patients that are required by Applicable Law, or
otherwise recommended by the Regulatory Authorities, to obtain or
maintain Regulatory Approvals, but excluding Post Approval
Studies.
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“Commercially
Reasonable Efforts”
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means,
with respect to a Party’s obligation to perform or achieve a
specified obligation or outcome of the Product and/or Optional
Product or generally under this Agreement, the efforts, expertise,
degree of skill, and resources that are comparable in quality and
scope to those efforts, expertise, degree of skill and resources
that are generally used by such Party to perform or achieve a
comparable obligation or outcome for a pharmaceutical product owned
or controlled by such Party, which has the same regulatory
requirements or status (for example, requires a prescription or is
available over-the-counter), is at a comparable stage of
development or product life as the Product and/or Optional Product,
and that has similar market potential as the Product and/or
Optional Product, taking into account issues of patent coverage,
relative safety and efficacy, product profile, the competitiveness
of the marketplace, the proprietary position of the compound or
product, relevant regulatory circumstances, the profitability of
the product (including pricing and reimbursement status achieved)
and other relevant risk factors, including technical, legal,
scientific, commercial and/or medical risk factors.
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“Commercialization”
“Competitive Product”
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means
any and all activities (after Regulatory Approval) directed to the
marketing, detailing and other promotion of the Product and/or
Optional Product, after Regulatory Approval for commercial sale has
been obtained. Commercialization shall include
marketing, distributing, offering to sell, selling, importing,
exporting or transporting for sale of the Product and/or Optional
Product, but shall not include Post Approval
Studies. When used as a verb, “Commercialising”
means to engage in Commercialization and “Commercialize”
and “Commercialized”
shall have a corresponding meaning.
means
any pharmaceutical product not manufactured by DAEWOONG or its
Affiliates that (i) has same mechanism of action with that of the
Product, and (ii) has same composition as olmesartan and
rosuavastatin combination, and (iii) launched or manufactured or
supplied in the Territory by any other persons than DAEWOONG,
including but not limited to AUTOTELIC, STOCOSIL or Distributor,
after the Effective Date of this Agreement.
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“Confidential
Information”
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means
any and all information of a confidential or sensitive nature
(including all Intellectual Property and Know-How) disclosed by a
Party to the other pursuant to this Agreement including, without
limitation, manufacturing, marketing, financial, personnel,
scientific and other business information and plans, and the
material terms of this Agreement, whether in oral, written, graphic
or electronic form.
Failure
to xxxx any of the Confidential Information as confidential or
proprietary shall not affect its status as Confidential Information
under the terms of this Agreement.
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“Control or Controlled”
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means
(a)in
respect of any partnership, corporation or other entity, the direct
or indirect ownership of more than fifty percent (50%) of the
outstanding shares or other voting rights of the subject entity
having the power to vote on or direct the affairs of the entity,
(or such lesser percentage which is the maximum allowed to be owned
by a foreign corporation in a particular jurisdiction);
and
(b)in
respect of any Patent, Know-How or other Intellectual Property
whether owned by or licensed to an entity, the possession of the
legal right and ability to grant the respective licenses or
sublicenses as provided herein without violating the terms of any
agreement or other arrangement with any Third Party;
and
the expressions Controlling and Controlled by shall be interpreted
accordingly.
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“Cost of Goods” or “COGS”
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means
the cost consisting of (a) Cost of materials used in production of
Product including but not limited to APIs, additives, and packages,
(b) labour and machine cost, and (c) overhead costs related to
production.
DAEWOONG
and STOCOSIL agree to review the market price of each API
(Olmesartan, Rosuvastatin) for the Product during the 1st quarter
of every year and calculate the average price of 3 suppliers
registered in the US-DMF for each active ingredient. Then, that
average price shall become effective on the last day of every 1st
quarter and shall be applied to calculate a new COGS after such
date.
Overhead
cost for production shall be calculated as 0.4 times the sum of
labour and machine cost.
*
Overhead cost = (labour and machine cost)*0.4
COGS
is to be no more than projected on Product COG (Date: Dec, 2014) as
provided to STOCOSIL during its due diligence
visit. This is to remains effective from the Effective
Date until expiration of the agreement. Thereafter,
pricing upper limit shal be permitted only at the time of contract
renewal, provided that price increases shall not exceed five
percent (5%) over the applicable price in effect for the expiring
term. In the event that the relevant governmental
pricing (e.g. Centers for medicare and Medicaid Services)
authorities in the Territory reduced the maximum bidding/retail
price of the Product/Optional Product making the current pricing
uncompetitive, Parties shal discuss in good faith a Product price
adjustment.
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“Delivery Terms”
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shall
be on FOB Incheon airport.
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“Development”
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means,
with respect to the Product and/or Optional Product, all activities
related to research, preclinical and other non-clinical testing,
test methods development and stability testing, toxicology,
formulation, quality assurance/quality control, including the
transfer of information, materials, Regulatory Documentation and
other technology with respect to the Product and/or Optional
Product, commercial scale-up, Clinical Trials and Post Approval
Studies, including Manufacturing in support thereof, statistical
analysis and report writing, market research and development, the
preparation and submission of INDs and NDAs, regulatory affairs
with respect to the foregoing, and all other activities necessary
or reasonably useful or otherwise requested or required by a
Regulatory Authority as a condition or in support of obtaining,
maintaining or expanding a Marketing Authorization. When
used as a verb, “Develop”
shall mean to engage in Development.
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“Development Costs”
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means
any and all costs and expenses recorded as an expense in accordance
with applicable accounting rules, related to the Development of a
Product, approved by a Development Plan. Development
costs shall include such costs in connection with the following
activites:
(a)pre-clinical
activity costs such as toxicology and formulation development, test
method development, stability testing, quality assurance, quality
control development and statistical analysis;
(b)clinical
costs including cost of goods for the conduct of the clinical
trials;
(c)regulatory
expenses relating to the conduct of Clinical Trials, wherever
performed, for the Product;
(d)Manufacturing
of Clinical Trial Supplies of Product for use in Clinical Trials
and any pre-clinical activities in support thereof;
(e)Manufacture,
purchase or packaging of comparators or placebo for use in Clinical
Trials;
(f)Development
of the Manufacturing process for Commercial Supplies of the
Product, scale-up, Manufacturing process validation, Manufacturing
improvements and qualification and validation of Third Party
contract manufacturers;
(g)Direct
charges for materials (including chemicals, animals and lab
supplies).
(h)Regulatory
filing costs including but not limited to manufacturing site
registration fees, FOFA, PDUFA, MDUFFMA.
(i)Insurances
such as product liability insurance, clinical trial insurance,
etc.
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“Development
Plan”
“Effective Date”
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means
the plan for Development of the Product and/or Optional Product,
including, without limitation, operating guidelines and estimated
filing dates, guidelines for filing Marketing Authorization, and
any pre-clinical trials and Clinical Trials to be conducted by
STOCOSIL.
means
the date on which all parties formally execute this
Agreement.
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“First Commercial Sale”
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means,
in respect of the Product and/or Optional Product in a country
within the Territory, the date on which that Product is first
shipped to wholesalers and retailers by STOCOSIL in commercial
quantities from its distribution centres for commercial sale to a
Third Party in such country after receipt of Marketing
Authorisation approval for such Product in such
country. Sales for test marketing, sampling and
promotional uses or Clinical Trials or research purposes or
compassionate uses will not be considered a First Commercial
Sale.
Further
means, in respect of the Product and/or Optional Product in a
country outside of the Territory except in Korea, the date on which
that Product is first shipped to wholesalers and retailers by
DAEWOONG in commercial quantities from its distribution centres for
commercial sale to a Third Party in such country after receipt of
Marketing Authorisation approval for such Product in such
country. Sales for test marketing, sampling and
promotional uses or Clinical Trials or research purposes or
compassionate uses will not be considered a First Commercial
Sale.
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“Force
Majeure”
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has
the meaning set out in Clause 21.5.
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“Good Clinical Practice” or
“GCP”
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shall
mean all applicable good clinical practice standards for the
design, conduct, performance, monitoring, auditing, recording,
analyses and reporting of clinical trials, including, as
applicable: (i) the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use (“ICH”), Harmonised Tripartite Guideline for
Good Clinical Practice (CPMP/ICH/135/95); (ii) the Declaration of
Helsinki (1964) as last amended at the 59th World Medical
Association (WMA) General Assembly in October 2008 and any further
amendments or clarifications thereto; (iii) regulations for
“Protection of Human Subjects”, “Institutional
Review Boards” and applications for IND, as set forth
respectively under 21 C.F.R. Parts 50, 56, and 312, as may be
amended from time to time;; and (iv) the equivalent Applicable Laws
in any relevant country or jurisdiction, each as may be amended and
applicable from time to time and in each case, that provide for,
among other things, assurance that the clinical data and reports
results are credible and accurate and protect the rights,
integrity, and confidentiality of trial subjects.
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“Good Laboratory Practice” or
“GLP”
“Good Manufacture Practice” or
“GMP”
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shall
mean all applicable good laboratory practice standards,
including: (i) 21 C.F.R. Part 58 (“Good Laboratory
Practice for Nonclinical Laboratory Studies”), as may be
amended from time to time, and (ii) the relevant Applicable Laws in
any relevant country or jurisdiction in the Territory, each as may
be amended and applicable from time to time
shall
mean all applicable current good manufacturing practices including,
as applicable: (i) the regulations for “Current
Good Manufacturing Practice in Manufacturing, Processing, Packing
or Holding of Drugs; General”, “Current Good
Manufacturing Practice for Finished Pharmaceuticals, “Current
Good Manufacturing Practice for Blood and Blood Components”
“General Biological Products Standards” and the
“Quality System Regulation”, as set forth respectively
under 21 C.F.R. Parts 210, 211, 606, 610 and 820, as may be amended
from time to time; (ii) the principles detailed in ICH Q7A
”Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients”; and (iii) the equivalent
Applicable Laws in any relevant country or jurisdiction, each as
may be amended and applicable from time to time.
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“Intellectual Property Rights”
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means
rights in any and all Patents, any industrial and intellectual
property of any kind granted or recognised under the laws of any
country including but not limited to (a) any
copyright, designs rights, Patents, logos, business
names or signs, domain names, database rights, moral rights,
including all rights or forms of protection having an equivalent or
similar nature or effect anywhere in the world, whether
enforceable, registered, unregistered or registerable (including
all renewals, extensions and applications for registration) in
respect of the same; and (b) any and all rights relating to
software, Confidential Information or Inventions. Trade
Marks are excluded from this definition.
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“STOCOSIL & AUTOTELIC Arising IP”
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means any and all Intellectual Property Rights and Know-How
which arise in connection with a Development Plan and
this Agreement, to the extent it relates to Product and/or Optional
Product or the Manufacture of the Optional Product. This to mean
any and all Drug Monitoring IPs and Drug Monitoring/Drug
combination IPs.
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“STOCOSIL & AUTOTELIC Background IP”
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means
any Intellectual Property Rights and Know How owned by, assigned to
or licensed to STOCOSIL and/or STOCOSIL Affiliates prior to the
Effective Date, which are necessary for the performance of a
Development Plan.
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“STOCOSIL Senior Representative”
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means:
for all disputes relating to development or regulatory issues,
STOCOSIL’s CEO
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“DAEWOONG Arising IP”
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means any and all Intellectual Property Rights and Know-How,
which arise in connection with a Development Plan, Manufacture of
the Product, and this Agreement, to the extent it relates to the
Product which does not incorporate any STOCOSIL Confidential
Information, STOCOSIL Background IP and/or STOCOSIL Arising
IP.
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“DAEWOONG Background IP”
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means any Intellectual Property Rights and Know-How owned or
Controlled, or licensed to or otherwise acquired by DAEWOONG and/or
DAEWOONG’s Affiliates prior to the Effective Date of
this Agreement and/or otherwise outside the scope of this Agreement
which are necessary to perform the obligations pursuant to this
Agreement.
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“DAEWOONG Senior Representative”
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means:
(i) for disputes relating to development or regulatory issues,
DAEWOONG’s Head of Products Development; or (ii) for all
other disputes, DAEWOONG’s CEO.
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“Know-How”
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means
any proprietary computer program(s), computer code(s), algorithm,
treatment algorithm, technology, technical, scientific and medical
information, methods of use, processes, techniques, ideas,
inventions (excluding any inventions disclosed in any Patent, that
is granted or published application), improvements, modifications,
know-how, practices, trade secrets, chemistry, manufacturing and
control data, quality control information and procedures, and
pharmacological, toxicological and preclinical and clinical test
data and results and regulatory information (including all
documentation and correspondence submitted or required to be
submitted to a Regulatory Authority, or received from a Regulatory
Authority, in connection with a Regulatory Approval in any
country), all of the foregoing pertaining to the Development,
Manufacture and/or Commercialization of the Product, but excluding
Patents associated with any of the foregoing.
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“Loss” or “Losses”
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means
liabilities, damages, and losses to Third Parties, costs and
expenses, including, but not limited to, the reasonable fees of
attorneys and other professionals.
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“Manufacture”
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means,
in respect of the Product, any and all activities related to the
purchasing (and/or producing) of Materials, processing, production,
sample retention, bulk packaging, primary & secondary
packaging, labeling, storing, testing, release and shipping of such
Product, including quality assurance and quality control and
stability testing, and includes the performance of any such
activity in connection with the Development of the Product, and
“Manufactured” and “Manufacturing” shall be
construed accordingly.
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“Manufacturing and Supply Agreement” or
“MSA”
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means
an agreement to be entered into by STOCOSIL and DAEWOONG which sets
forth the terms and conditions under the Product to be
Commercialized by STOCOSIL will be Manufactured and supplied by
DAEWOONG to STOCOSIL. The key terms of this
Manufacturing and Supply Agreement are summarised in Schedule 1.
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“Manufacturing Licence”
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means,
in respect to the Product, all licences and/or approvals necessary
for, or in connection with, the Manufacture of such Product at the
Manufacturing Site(s).
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“Manufacturing Site(s)”
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means
that (or those) manufacturing sites used or owned by DAEWOONG or
its Affiliates or its or their respective permitted subcontractors
at which the Product will be Manufactured, either pursuant to this
Agreement or pursuant to the Manufacturing and Supply
Agreement.
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“Marketing Authorizations"
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means,
in respect of the Product and/or Optional Product in a country in
the Territory, all approvals, licenses, registrations or
authorizations issued by the relevant Regulatory Authority in such
country of the Territory enabling STOCOSIL to commercialize the
Product and/or Optional Product in that country, including Price
and Reimbursement Approval.
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“Materials”
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means,
in respect of a Product, all active and raw materials (including
API), intermediates, processing aids, ingredients, components,
packaging and labelling materials and other materials that are
required to Manufacture that Product.
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“Net Sales”
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means,
as to STOCOSIL or DAEWOONG and with
respect to a given period of time, gross invoiced sales of the
Product and/or Optional Product to Third Parties by either Party or
its Affiliates or sublicensees in such period, less the following
deductions from such gross amounts which are actually incurred,
allowed, paid, accrued or specifically
allocated:
(a)
Cost of Good Sold, defined in above
(b)
credits or allowances actually granted for damaged Product and/or
Optional Product, returns or rejections of Product, price
adjustments, and billing errors;
(c)
governmental and other rebates (or equivalents thereof) granted to
managed health care organizations, pharmacy benefit managers (or
equivalents thereof), national, state/provincial, local, and other
governments, their agencies and purchasers, and reimbursers, or to
trade customers, including but not limited to, wholesalers and
chain and pharmacy buying groups;
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(d)
such Party’s normal and customary trade, cash and quantity
discounts, allowances, and credits actually allowed or
paid;
(e)
commissions allowed or paid to Third Party distributors, brokers,
or agents other than sales personnel, sales representatives, and
sales agents employed by such Party;
(f)
transportation costs, including insurance, for outbound freight
related to delivery of Product to the extent included in the gross
amount invoiced;
(g)
sales taxes, value added taxes (VAT), and other taxes directly
linked to the sales of Product to the extent included in the gross
amount invoiced;
(h)
the actual amount of any write offs for bad debt directly relating
to sales of Product in the period; and
(i)
any other items actually deducted from gross invoiced sales amounts
as reported by such Party in its financial statements in accordance
with the International Financial Reporting Standards. Sales between
or among either Party and its Affiliates or sublicensees will be
excluded from the computation of such Party’s Net Sales, but
the subsequent final sales to a Third Party by such Affiliates or
sublicensees will be included in the computation of such
Party’s Net Sales.
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“Patent”
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means
(a) all national, regional and international patent applications,
including priority and provisional patent applications, (b) all
patent applications derived from or claiming priority from the
foregoing patent applications (a), including divisionals,
continuations, continuations-in-part, converted provisionals, and
continued prosecution applications, (c) any and all patents that
have issued or been granted or in the future issue or are granted
from the foregoing patent applications ((a) and (b)), including
without limitation patents for inventions,
utility models, xxxxx patents, design patents and certificates of
invention, (d) any and all reissues, re-examinations,
revalidations, confirmations, restorations or extensions, including
any patent term extensions, supplementary protection certificates
and the like of the foregoing patents or patent applications ((a),
(b) and (c)).
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“Phase I”
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means,
with respect to the Product, a clinical study identified as a Phase
I Study in the Development Plan and conducted in humans on a
pharmaceutical product with the primary purpose of determining
safety, metabolism and pharmacokinetic properties, and clinical
pharmacology of such pharmaceutical product, and that is consistent
with 21 C.F.R. § 312.21(a) and/or, as applicable, other
comparable Laws.
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“Phase II”
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means,
with respect to the Product, a clinical study identified as a Phase
II Study in the Development Plan and conducted in human patients
designed to evaluate clinical efficacy and safety for such product
for one or more indications and that is consistent with 21 C.F.R.
§ 312.21(b) and/or, as applicable, other comparable
Laws.
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“Phase III”
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means,
with respect to the Product, a clinical study identified as a Phase
III Study in the Development Plan and conducted as a pivotal trial
for purposes of filing an Marketing Authorisation application for
the Product that provides for the clinical study of such Product on
sufficient numbers of patients to confirm with statistical
significance the efficacy, and confirm the safety of such Product
sufficient to support such MAA for such Product, and is consistent
with 21 C.F.R. § 312.21(c) and/or, as applicable, other
comparable Laws.
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“Phase IV”
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means
a human clinical trial of a product that is not included in the
original NDA submission for such product for an indication, but is
required to obtain or maintain the approval by a competent
Regulatory Authority of the NDA for such product for such
indication, including studies conducted to fulfil commitments made
as a condition of NDA approval or any subsequent human clinical
trials requested or required by a competent Regulatory Authority as
a condition of maintaining such approval.
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“Price and Reimbursement Approval”
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means
the approval of the price and the reimbursement category (where
relevant) for the Product and/or Optional Product as established
from time to time by the relevant Regulatory Authority in the
applicable country in the Territory.
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“Product”
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means
a pharmaceutical product (including any future formulation), which
contains only Olmesartan plus Rosuvastatin fixed dose combination
(FDC) or its new formula, including but not limited to any
modifications or update, for HTN.
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“Optional Product”
“Post Approval Studies”
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means
a pharmaceutical product (including any future formulation), which
contains only Olmesartan plus Rosuvastatin fixed dose combination
(FDC) to be used with Therapeutic Drug Monitoring (TDM)for
recalcitrant or resistant HTN. All Intellecture
Properties of TDM are exclusively owned by AUTOTELIC, and AUTOTELIC
will grant a royalty bearing non-exclusive license to use in
conjunction with the a pharmaceutical product (including any future
formulation), which contains only Olmesartan plus Rosuvastatin
fixed dose combination (FDC).
means
a human clinical study, or other test or study with respect to a
product for an indication that (a) is conducted solely in support
of pricing or reimbursement for such product in the Territory or
(b) is not required to obtain or maintain Marketing Authorization
for such product for such indication (for clarity, any human
clinical study that is intended to expand the label for a product
shall be a Clinical Trial). Subject to the foregoing,
Post Approval Studies may include epidemiological studies,
modelling and pharmacoeconomic studies, post-marketing surveillance
studies, investigator sponsored studies and health economics
studies, but shall exclude Phase IV Clinical Trials.
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“Regulatory Authority”
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means
any applicable international, supra-national, federal, national,
regional, state, provincial or local regulatory agencies,
departments, bureaus, commissions, councils or other government
entities regulating or otherwise exercising authority with respect
to the Development, Manufacturing and Commercialization of the
Product and/or Optional Product.
|
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|
“Regulatory Dossier”
|
means
in relation to the Product and/or Optional Product, the technical
registration dossier produced in relation to that Product and/or
Optional Product (including any and all information, processes,
techniques, data and Intellectual Property Rights) in an electronic
format which allows for compilation into the relevant country
format according to the regulatory requirements necessary to obtain
and maintain Marketing Authorizations for the relevant Product in
any country in the Territory and outside of the
Territory.
|
|
“Regulatory Documentation”
|
means,
with respect to the Product and/or Optional Product, all Regulatory
filings and supporting documents created, submitted to a Regulatory
authority, and all data contained therein, including, without
limitation, any investigator’s brochures, study protocols,
DMF (Drug Master File), correspondence to and from a Regulatory
Authority, minutes from teleconferences with Regulatory
Authorities, registrations and licences, regulatory drug lists,
advertising and promotion documents shared with Regulatory
Authorities, adverse event files, complaint files and manufacturing
records.
|
|
“Senior Representatives”
|
means
the DAEWOONG Senior Representative and the STOCOSIL Senior
Representative.
|
|
“Specifications”
“Sponsor”
|
means
the technical specifications for the Product to be
included in the relevant Quality Agreement.
means
Autotelic, LLC, Autotelic, Inc. and its shareholders or members
currently who own the majority shares of common stocks
of Stocosil, Inc. And they will provide necessary capital and
services until Stocosil is able to operate as a stand-alone
company. For the purpose of this Agreement, Autotelic,
LLC and Autotelic, Inc. will assume all of Stocosil Inc.’s
responsibilities, obligations, and liabilities until Stocosil Inc.
successfully raises total of $20 million in equity.
|
|
“Step-In Rights”
|
has
the meaning given in Clause 4.5 and 6.3.
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|
“Supply Price”
|
means,
in respect of the Product Manufactured and supplied by DAEWOONG to
STOCOSIL pursuant to the Manufacturing and Supply Agreement, the
price paid or payable by STOCOSIL for such Product under the
Manufacturing and Supply Agreement, which is Cost of Goods plus
50%..
|
|
“Term”
|
means
the term of this Agreement as set out in Clause 3.
|
|
“Territory”
2.8.0
|
means
the United States, Canada, Australia, Japan, Taiwan, and part of
Latin American countries of which DAEWOONG are not currently
marketing and/or have no plan to market the Product and/or Optional
Product in the future.
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|
“Third Party”
|
means
a person other than STOCOSIL, AUTOTELIC, DAEWOONG or their
respective Affiliates.
|
|
“Trade Xxxx(s)”
|
means
in relation to any Party, registered and unregistered trademarks,
including, inter alia, words and logos, and any applications for
registration thereof, and any Intellectual Property rights residing
in such trade marks owned and/or used by that Party and/or its
Affiliates and which are used in relation to the Product and/or
Optional Product.
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|
“Valid Claim”
|
means
a claim of any issued, unexpired Patent owned or Controlled by
STOCOSIL that shall not have lapsed, been cancelled or abandoned,
been donated to the public, finally disclaimed, nor held finally
invalid or unenforceable by a court of competent jurisdiction in an
unappealed or unappealable decision and where the claim relates to
composition of matter or method of use of the Product and/or
Optional Product.
|
|
“VAT"
2.8.1
|
means
the value added taxes imposed by tax authority of each country of
the Territory and outside of the Territory of which the Product
and/or Optional Product are being marketed.
|
|
“Waste”
|
means
any unwanted substance including regulated waste, non product waste
(such as packaging) and manufacturing waste (such as scrap material
in factories), irrespective of whether it is capable of being
recycled or recovered or has any value.
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1.2 In
this Agreement:
1.2.1 unless
the context otherwise requires, all references to a particular
clause or schedule shall be a reference to that clause or schedule
in or to this Agreement as it may be amended from time to time
pursuant to this Agreement;
1.2.2 the
headings are inserted for convenience only and shall be ignored in
construing this Agreement; unless the contrary intention appears,
words importing the masculine gender shall include the feminine and
vice versa and words in the singular include the plural and vice
versa;
1.2.3 any
reference to persons includes natural persons, firms, partnerships,
limited liability partnerships, companies, corporations,
unincorporated associations, local authorities, governments,
states, foundations and trusts (in each case whether or not having
separate legal personality) and any agency of any of the
above;
1.2.4 any
phrase introduced by the terms “including”,
“include”, “in particular” or any similar
expression shall be construed as illustrative and shall not limit
the sense of the words preceding those terms;
1.2.5 any
reference to a statute, statutory provision or subordinate
legislation (legislation) (except where the context otherwise
requires) (i) shall be deemed to include any by-laws, licences,
statutory instruments, rules, regulations, orders, notices,
directions, consents or permissions made under that legislation and
(ii) shall be construed as referring to any legislation which
replaces, re-enacts, amends or consolidates such legislation (with
or without modification) at any time;
1.2.6 any
reference to a Party includes a reference to their respective
successors-in-title and permitted assignees, including
licensees.
2.
GRANT OF RIGHTS
2.1
Grants to STOCOSIL
2.1.1 Subject
to the terms and conditions of this Agreement, DAEWOONG hereby
grants to STOCOSIL, and STOCOSIL hereby accepts:
(a)
During
the Term of Agreement, DAEWOONG grants STOCOSIL and its designated
Affilate(s) for the development and commercialization of
the Product and Optional Product, an exclusive right to
register, import, promote, market, distribute (including through
tiers of distributors), offer for sale, sell, have sold and
otherwise commercialize the Product and Optional Product in the
Territory below during the term of this Agreement.
(b)
an
exclusive license (with the right to grant sub-license, as provided
in Clause 2.3) under DAEWOONG Background IP, DAEWOONG’s
Confidential Information, DAEWOONG’s Know-How and DAEWOONG
Arising IP to (a) Develop,and Commercialize the Product and/or
Optional Product in the Territory; (b) seek and obtain Regulatory
Approvals for the Product and/or Optional Product in the Territory,
and (c) use and reference, with the right to grant sublicenses, as
provided in Clause 2.3, the DAEWOONG Regulatory Dossier; provided,
however, DAEWOONG shall retain the right to practice or use the
DAEWOONG Background IP, DAEWOONG’s Confidential Information,
DAEWOONG’s Know-How and DAEWOONG Arising IP as may be
necessary to conduct its Development obligations under the
Development Plan in accordance with the terms and conditions of
this Agreement. For the avoidance of doubt, the items
under discussion are specific to the Product ie.
formulation patent(s) for Product and/or Optional
Product.
(c) a
non-exclusive, royalty-free licence (with the right to grant
sub-licenses, as provided in Clause 2.3) to DAEWOONG Background IP,
DAEWOONG Arising IP, DAEWOONG Confidential Information, and
DAEWOONG Know-How, solely for the performance of “its
obligations”, defined below, under this Agreement and in
accordance with a Development Plan. For the
avoidance of doubt, “its obligations” means any
obligation not specificly to the Product ie. formulation patent(s)
for FDC in general and not specific to Product and/or Optional
Product.
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2.1.2 STOCOSIL
shall own and retain all right, title and interest in and to the
Product Regulatory Documentation and the Optional Product
Regulatory Documentation (including Regulatory Authorization with
respect to a Product), as well as all Clinical Trial data in the
Territory. Without limitation to any other term or
condition of this Agreement, DAEWOONG shall promptly (a) deliver to
STOCOSIL in writing, and shall cause its Affiliates to so deliver,
any Product Regulatory Documentation, the Optional Product
Regulatory Documentation and Clinical Trial data, and (ii), without
additional consideration, assign and transfer, and cause its
Affiliates to so assign and transfer, to STOCOSIL (or its Affiliate
or other designee) all of their respective rights, titles and
interests in and to such Product Regulatory Documentation, the
Optional Product Regulatory Documentation and Clinical Trial data
in the Territory. For the avoidance of doubt, DAEWOONG
will transfer any Regulatory Documentation that currently exists
upon executing this Agreement and as soon as possible with respect
to any new Regulatory Documentation or data generated
thereafter.
2.2
Grants to DAEWOONG
2.2.1
Subject
to the terms and conditions of this Agreement, AUTOTELIC and/or
STOCOSIL hereby grants to DAEWOONG, and DAEWOONG hereby
accepts:
(a) an
exclusive and royalty bearing access (with the right to grant
sub-licenses, as provided in Clause 2.3) to the STOCOSIL’s
Regulartory Dossier, STOCOSIL’s Regulatory Documentation,
STOCOSIL and AUTOTELIC Background IP, STOCOSIL and AUTOTELIC
Arising IP, STOCOSIL’s Confidential Information,
STOCOSIL’s and AUTOTELIC’s Know-How of the Product
and/or Optional Product outside of the Territory in order to seek
and obtain Regulatory Approvals and/or Marketing Authorization for
the Product and/or Optional Product outside of the Territory, as
required per Applicable Laws . For the avoidance of doubt, the
items under discussion hereinwith are specificly to the Product
and/or Optional Product such as TDM related IPs for treatment of
resistant hypertension using ARBs.
(b) a
non-exclusive, royalty-free licence (with the right to grant
sub-licenses, as provided in Clause 2.3) to STOCOSIL and AUTOTELIC
Background IP, STOCOSIL and AUTOTELIC Arising IP, STOCOSIL’s
Confidential Information, and STOCOSIL’s and
AUTOTELIC’s Know-How, solely for the performance of
DAEWOONG’S obligations under the Development Plan in
accordance with this Agreement. For the avoidance of doubt, the
items under discussion hereinwith are specificly to the Product or
Optional Product such as TDM for improvement of therapeutics
including but not exclusive to ARBs.
2.3 Sublicenses
2.3.1
Subject
to Clause 5.3, STOCOSIL may sublicense any of its rights under this
Agreement to Develop, Manufacture and Commercialize the Product
and/or Optional Product in whole or in part to one or more of its
Affiliates or any Third Party performing work under this Agreement,
provided that the rights sublicensed to any Affiliate shall
automatically terminated upon a change of control of such Affiliate
in connection with which such Affiliate ceases to be an Affiliate
of STOCOSIL, or in the event of a Third Party, its service
agreement with STOCOSIL expires or is terminated. Iin
the event of Change in ownership or effective control, this
Agreement shall remain in full force and effective with the
acquirer and/or successor.
2.3.2
DAEWOONG
may sublicense its right under this Agreement to Develop,
Manufacture and Commercialize the Product and/or Optional Product
outside the Territory in whole or in part to one or more of its
Affiliates performing work under this Agreement, provided that the
rights sublicensed or subcontracted to any Affiliate shall
automatically terminate upon a change of control of such Affiliate
in connection with which such Affiliate ceases to be an Affiliate
of DAEWOONG.
2.3.3
Both
Parties may sublicense its right under this Agreement to Develop,
Manufacture and Commercialize the Product and/or Optional Product
in whole or in part in appropriate Territories to one or more
contract research organizations performing work under this
Agreement, subject to prior a written consent from each other, such
consent not to be unreasonably withheld. Both Parties shall have
thirty (30) Business Days to review each other’s
proposal.
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2.3.4 Each
Party shall ensure that each of its Affiliates and sublicenses
accepts and complies with all of the terms and conditions of this
Agreement as if such Affiliates or sublicenses were a party to this
Agreement and each Party shall be primarily liable for its
Affiliates’ and sublicenses or subcontractors performance
under this Agreement.
3.
EFFECTIVE DATE AND TERM
3.1
Unless
earlier terminated in accordance with Clause 18, this Agreement
shall remain in full force from the Effective Date and shall remain
in force for a period of ten (10) years from the
First date of Commerical Sale of the Optional Product in
any country of the Territoryand thereafter shall be automatically
renewed on an annual basis unless either Party gives a six (6)
month notice to terminate the Agreement.
4.
DEVELOPMENT
4.1
Initial Obligations by AUTOTELIC and STOCOSIL
4.1.1 AUTOTELIC
and its majority shareholders or members have created
and own majority shares of common stocks of a
new legal entity, STOCOSIL, Inc. for the purpose of the Development
and Commercialization of the Product and/or Optional Product in the
Territory.
4.1.2 AUTOTELIC
will fund STOCOSIL and provide necessary personnel, infrastructure,
capabilities, and service to ensure the successful Development and
Commercialization of the Product and/or Optional
Product.
4.1.3 STOCOSIL
with an assistance from AUTOTELIC will also be responsible for
raising additional and necessary capital for such entity
for the purpose of the Development and Commercialization
of the Product and/or Optional Product in the
Territory.
4.2 Development
Plan
4.2.1
Development
of the Product and/or Optional Product shall be governed by a
multi-year Development Plan, which shall be prepared by STOCOSIL,
and shall set forth material anticipated Development activities and
timelines until the date that the corresponding Product receives
Regulatory Authorization in the countries in the Territory
specified in such Development Plan. Both Parties
recognize that, in general, the Development Plans represent
projections only and may be subject to change during the
Development process and is not a guarantee that Marketing
Authorization in any country is received in accordance with any
timelines.
4.2.2 Diligence:
Standards of Conduct
4.2.2.1 With
respect to the Product and Optional Product, the Parties agree to
use Commercially Reasonable Efforts to undertake, and to bear the
costs associated with, the key Development activities of the
countries in the Territory and countries outside of the
Territory.
4.2.2.2 Each
Party shall use Commercially Reasonable Efforts to develop the
Product and/or Optional Product in accordance with timelines set
out in the relevant Development Plans.
4.2.2.3 The
Parties shall conduct all of their respective activities in
connection with this Agreement with reasonable skill and care in a
good scientific manner, and in compliance in all material respects
with all requirements of Applicable Laws, rules and regulations,
and, to the extent applicable, all other requirements of GMP, GLP
and current GCP.
4.2.2.4 Both
Parties acknowledge the importance of ensuring that the activities
under this Agreement are undertaken in accordance with the
following good data management practices:
(a)
data
being generated using sound scientific techniques and
processes;
(b)
data
being accurately and reasonably contemporaneously recorded in
accordance with good scientific practices by the persons
responsible for conducting the research under this
Agreement;
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(c)
data
being analysed appropriately without bias in accordance with good
scientific practices; and
(d)
data
and results being stored securely and in a form which can be easily
retrieved.
4.2.2.5 The
Parties agree to implement the necessary processes to ensure a
close, co-operative working relationship in order to enable both
Parties to fulfil their obligations under this
Agreement.
4.2.2.6 During
the Term of this Agreement, each Party shall provide to the other
Party all such Party’s Know-How (i.e., in case of DAEWOONG,
DAEWOONG Know-How, and in the case of STOCOSIL, all STOCOSIL
Know-How) and that has not previously been provided hereunder, in
each case promptly upon request by the other Party. The
Party providing such Party’s Know-How shall provide the same
in electronic form to the extent the same exists in electronic
form, and shall provide copies as reasonably requested and an
opportunity for the other Party or its designee to inspect (and
copy) all other materials comprising such Know-How (including for
example, original patient report forms and other original source
data). The Parties will cooperate and reasonably agree
upon formats and procedures to facilitate the orderly and efficient
exchange of the DAEWOONG Know-How and the STOCOSIL
Know-How.
4.2.2.7 The
Parties acknowledge that the outcome and results of each
Development Plan are uncertain; accordingly, neither Party
guarantees any outcome thereof or otherwise warrants that any
product, , including the Product or the Optional Product, will be
successfully Developed as a result of a Development
Plan.
4.3 Subcontracting
4.3.1 Either
Party may subcontract with any Third Party to perform any of its
obligations described above in Clause 4.2.2.1; provided that no
such permitted subcontracting shall relieve such Party of any
liability or obligation hereunder except to the extent they are
satisfactorily performed by such subcontractor; provided further
that such Party shall not subcontract any such obligations unless
the agreement pursuant to which it engages any Third Party
subcontractor (i) is consistent in all material respects with this
Agreement, and (ii) contains terms obligating such subcontractor to
comply with the confidentiality, intellectual property, and all
other relevant provisions of this Agreement.
4.3.2 The
Party that subcontracts with a Third Party shall be responsible for
managing said Third Party.
4.4 Development
Costs
4.4.1 The
Development Costs of the Product and Optional Product in the
Territory shall be entirely borne by STOCOSIL
4.4.2 The
Development Costs of the Product and Optional Product outside of
the Territory shall be entirely borne by DAEWOONG.
4.5
Step-In Rights at the Development Stage for
DAEWOONG
4.5.1 Where
STOCOSIL decides to permanently stop all Development of the Product
and/or Optional Product in the Territory, it shall give written
notice at any time to DAEWOONG of such fact setting out the
countries to which the notice applies. Upon receipt of
such notice, DAEWOONG will have the option (“Step-In
Rights”) to further Develop the Product and Optional Product
(“Retained Product”) in such country (each, a
“Retained Countries”) in the
Territory. If DAEWOONG exercises its Step-In
Rights under this Clause:
(a)
DAEWOONG
shall reimburse STOCOSIL all Development Costs upto that point;
and
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(b)
STOCOSIL
shall grant DAEWOONG an exclusive license, royalty-bearing under
STOCOSIL Background IP, STOCOSIL Arising IP, STOCOSIL’s
Confidential Information and STOCOSIL Know-How (with the right to
grant sub-license, as provided in Clause 2.3) to make, have made,
use, develop, sell, offer for sale and import the Retained Product
in the Territory in the affected country or countries (except for
the TDM owned by AUTOTELIC: but AUTOTELIC grants a non-exclusice
license to use the TDM for the Optional Product of the Retained
Product). For the Product of the “Retained
Product”, DAEWOONG will not pay any further royalty or any
other profit sharing payments. For the Optional Product
of the “Retained Product”, DAEWOONG shall pay 5% of the
annual Net Sales of the Optional Product as an annual royalty
payment for the duration of this Agreement.
4.6 Step-In
Rights at the Development Stage for STOCOSIL
4.6.1 Where
DAEWOONG decides to permanently stop all Development of the Product
and/or Optional Product outside the Territory, it shall give
written notice at any time to STOCOSIL of such fact setting out the
countries to which the notice applies. Upon receipt of
such notice, STOCOSIL will have the option (“Step-In
Rights”) to further Develop the Retained
Product. If STOCOSIL exercises its Step-In Rights
under this Clause:
(a)
STOCOSIL
shall reimburse DAEWOONG all Development Costs upto that point;
and
(b)
DAEWOONG
shall grant STOCOSIL an exclusive license, royalty-free under
DAEWOONG Background IP, DAEWOONG Arising IP, DAEWOONG’s
Confidential Information and DAEWOONG Know-How (with the right to
grant sub-license, as provided in Clause 2.3) to make, have made,
use, develop, sell, offer for sale and import the Retained Product
in Retained Countries outside of the Territory in the affected
country or countries. DAEWOONG will be the main
manufacturer and supplier of the Retained Product (except for the
TDM owned by AUTOTELIC) to STOCOSIL under the same terms and
conditions of this Agreement.
5. REGULATORY
5.1
The
Parties shall work together to produce high quality regulatory
files relating to the Product and Optional Product. Regulatory
Dossiers and Regulatory Documentation relating to the Product and
Optional Product shall be prepared by the Parties so as to meet the
standards and all Applicable Law requirements in each countries of
the Territory. Nevertheless, DAEWOONG, or its
affiliates, shall provide STOCOSIL all Regulatory Dossiers,
Regulatory Documents and other related supporting documents it in
order to support STOCOSIL for registration of the Product and/or
Optional Product in the Territoy.
5.2
STOCOSIL
shall be responsible for implementing all regulatory activities and
all regulatory filings for each of the Product and/or Optional
Product in the Territory in its own name and shall be the owner of
all Marketing Authorisation, Regulatory Dossier and Regulatory
Documentation other than as described in Clause 5.3
below. For the avoidance of doubt, registration fee for
such filing in the Territory shall be borne by
STOCOSIL.
5.3
DAEWOONG
shall be responsible for implementing all regulatory activities and
all regulatory filings for each of the Product and/or Optional
Product outside of the Territory in its own name and shall be the
owner of all Marketing Authorisation, Regulator Dossier and
Regulatory Documentation. For the avoidance of doubt,
registration fee for such filing outside of the Territory shall be
borne by DAEWOONG. The Parties shall work together to
ensure a consistent global Regulatory strategy.
5.4
DAEWOONG
shall provide, as soon as physically possible, access to STOCOSIL
of DAEWOONG’s existing Product ownership of all Korean
Marketing Authorization, Regulatory Dossier and Regulatory
Documentation.
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5.5
STOCOSIL,
under Step-in Rights, shall transfer to DAEWOONG as soon as
possible after its decision to permanently stop with the
Development and/or Commercialization the Product and/or Optional
Product in a particular country within the Territory, the ownership
of the respective Marketing Authorisation, Regulatory Dossier and
Regulatory Documentation. DAEWOONG, under Step-in Rights, shall
transfer to STOCOSIL as soon as possible after its decision to
permanently stop with the Development and/or
Commercialization the Product and/or Optional Product in a
particular country outside the Territory, the ownership of the
respective Marketing Authorisation, Regulatory Dossier and
Regulatory Documentation.
5.6
DAEWOONG
will not have ownership to the Regulatory Documentation generated
by STOCOSIL, unless it is transferred to DAEWOONG in accordance
with Clause 5.5. DAEWOONG will, however, have rights to
access to such Regulatory Documentation to the extent necessary for
DAEWOONG to obtain its Marketing Authorisation for the Product
and/or Optional Product outside of the Territory.
5.7
STOCOSIL
will not have ownership to the Regulatory Documentation generated
by DAEWOONG, unless it is transferred to STOCOSIL in accordance
with Clause 5.5. STOCOSIL will, however, have access to
such Regulatory Documentation to the extent necessary for STOCOSIL
to obtain its Marketing Authorisation for the Product and/or
Optional Product in the Territory.
5.8
Upon
STOCOSIL’s request and at STOCOSIL’s expense (to the
extent that it is necessary), DAEWOONG shall:
(a)
provide
appropriate expertise to assist STOCOSIL to fulfil its obligations
under Clause 5.2;
(b)
send
appropriately qualified representatives to attend meetings with any
Regulatory Authority in the Territory;
(c)
support
STOCOSIL in replying to regulatory queries related to CMC and GMP;
and
(d)
support
STOCOSIL in cGMP audits by Regulatory Authorities.
5.9
Upon
DAEWOONG’s request and at DAEWOONG’s
expense (to the extent that it is necessary), STOCOSIL
shall:
(a)
provide
appropriate expertise to assist DAEWOONG to fulfil its obligations
under Clause 5.3; and
(b)
send
appropriately qualified representatives to attend meetings with any
Regulatory Authority outside of the Territory.
5.10
Each
Party shall maintain, or cause to be maintained, records of its
respective Development activities in sufficient detail and in good
scientific manner appropriate for Patent and Regulatory purposes,
which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in the performance of
its respective Development activities, and which shall be retained
by such Party for at least five (5) years after the expiration or
termination of this Agreement, or for such longer period as may be
required by Applicable Law. Each Party shall have the
right, during normal business hours and upon reasonable notice, to
inspect and copy any such records, except to the extent that a
Party reasonably determines that such records contain Confidential
Information that is not licensed to the other Party, or to which
the other Party does not otherwise have a right of access
hereunder.
5.11
In
the event of a dispute with respect to the content of any
regulatory filing or Regulatory Dossier, Regulatory Documentation,
Product labelling, or the decision to file a drug approval
application, the dispute will be resolved amicably. If
there is no resolution, STOCOSIL will have the final decision
making authority with respect to the Product and/or Optional
Product in the Territory, and DAEWOONG will have the final decision
making authority with respect to the Product and/or Optional
Product outside of the Territory.
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5.12
Each
Party agrees to share relevant information in order to promote
successful Development and Commercialization of the Product and
Optional Product within the Territory as well as outside of the
Territory. Each Party shall promptly notify each other
of relevant information.
6. COMMERCIALIZATION
6.1 Commercialization
of the Product and/or Optional Product
6.1.1
It
is hereby agreed that:
(a)
subject
to Clause 2.1, STOCOSIL shall have the sole and exclusive right to
Commercialize the Product and/or Optional Product either itself or
through its Affiliates and/or Third Parties in the
Territory;
(b)
subject
to Clause 2.2, DAEWOONG shall have the sole and
exclusive right to Commercialize the Product and/or Optional
Product either itself or through its Affiliates and/or Third
Parties outside of the Territory.
(c)
STOCOSIL
shall Commercialize the Product using a name and trade xxxx that is
not the same as or confusingly similar to any name or DAEWOONG
Trade Xxxx used/or owned by DAEWOONG or its
Affiliates.
(d)
DAEWOONG
shall Commercialize the Product and/or the Optional Product using a
name and trade xxxx that is not the same as or confusingly similar
to any name or STOCOSIL Trade Xxxx used/or owned by STOCOSIL or its
Affiliates.
6.1.2 STOCOSIL,
at its sole expense and using Commercially Reasonable Efforts,
shall be responsible for sales and marketing activities for the
Product and/or Optional Product in the Territory, including
responsibility for any decisions and negotiations with relevant
governmental authorities and/or agencies regarding Price and
Reimbursement Approval of the Product and/or Optional Product in
the Territory. STOCOSIL will sell, distribute, and book
all sales of the Product and/or Optional Product in the
Territory.
6.1.3 DAEWOONG,
at its sole expense and using Commercially Reasonable Efforts,
shall be responsible for sales and marketing activities for the
Product and/or Optional Product in the Territory, including
responsibility for any decisions and negotiations with relevant
governmental authorities and/or agencies regarding Price and
Reimbursement Approval of the Product and/or Optional Product
outside of the Territory. DAEWOONG will sell,
distribute, and book all sales of the Product and/or Optional
Product outside of the Territory.
6.2 Commercialization
Obligations
6.2.1 Upon
receipt of the Marketing Authorization with respect to each Product
and/or Optional Product, subject to the terms of this Agreement,
the Parties shall use Commercially Reasonable Efforts to
Commercialize and Manufacture for commercial supply such Product
and/or Optional Product to the extent provided for, and in
accordance with, the relevant marketing plan and approved
budget. Each Party shall have the right to satisfy
its diligence obligations under this Clause 6.2.1 through its
Affiliates and permitted Third Parties, as the case may
be.
6.3 Step-In
Rights at the Commercialization Stage for
DAEWOONG
6.3.1
Where
STOCOSIL decides to permanently stop Commercialize the Product
and/or Optional Product in a Country within the Territory, it shall
give written notice promptly to DAEWOONG of such fact
setting out the countries to which the notice
applies. Upon receipt of such notice, DAEWOONG will have
the option (“Step-In Rights) to further Commercialize such
Products (each, a “Retained Product”) in such country
(each, a “Retained Countries”). In the event
that DAEWOONG exercises its Step-In Rights under this Clause
6.3.1:
(a)
unless
otherwise agreed with STOCOSIL, DAEWOONG agrees to Commercialize
such Retained Products using a name and Trade Xxxx that it has come
up with that is not the same as or confusingly similar to any name
or STOCOSIL Trade Xxxx used and/or owned by STOCOSIL or its
Affiliates;
(b)
DAEWOONG
shall pay to STOCOSIL an annual royalty payment equal to five
percent (5%) of the Product and seven percent (7%) of
the Optional Product of DAEWOONG’s Net Sales of
such Retained Products in such Retained Countries. For
the avoidance of doubt, royalties are not based on Patents;
and
(c)
STOCOSIL
shall transfer the Marketing Authorisation to the extent legally
permissible to do so and DAEWOONG shall reimburse STOCOSIL all
costs associated with the transfer of the Marketing
Authorisation.
6.4 Step-In
Rights at the Commercialization Stage for
STOCOSIL
6.4.1 Where
DAEWOONG decides to permanently stop Commercialize the Product
and/or Optional Product in a country outside of the Territory, it
shall give written notice promptly to STOCOSIL of such
fact setting out the countries to which the notice
applies. Upon receipt of such notice, STOCOSIL will have
the option (“Step-In Rights”) to further Commercialize
such Products (each, a “Retained Product”) in such
country (each, a “Retained Countries”). In
the event that STOCOSIL exercises its Step-In Rights under this
Clause 6.4.1:
(a)
unless
otherwise agreed with DAEWOONG, STOCOSIL agrees to Commercialize
such Retained Products using a name and Trade Xxxx that it has come
up with that is not the same as or confusingly similar to any name
or DAEWOONG Trade Xxxx used and/or owned by DAEWOONG or its
Affiliates;
(b)
DAEWOONG
will remain as the exclusive manufacturer and supplier of the
Retained Products in the Retained Countries, except for the TDM
owned by AUTOTELIC, for STOCOSIL under the same terms and
conditions of this Agreement;
(c)
DAEWOONG
shall transfer the Marketing Authorisation to the extent legally
permissible to do so and STOCOSIL shall reimburse DAEWOONG all
costs associated with the transfer of the Marketing Authorisation
and development costs associated with obtaining the Marketing
Authorisation; and
(d)
In
order to avoid delay in commercialization of the Optional Product
outside of the Territory, STOCOSIL and DAEWOONG will review the
Development and Commercialization progress by DAEWOONG in countries
outside of the Territory for the Product and Optional Product
within six (6) month of obtaining an US FDA Marketing
Authorizations for the Optional Product by STOCOSIL. At
that time, STOCOSIL and DAEWOONG will, in good faith, discuss and
negotiate whether STOCOSIL should exercise its Step-In rights in
countires outside of the Territory where DAEWOONG has not made
“Substantial Progress” in obtaining the Marketing
Authorizations for the Product. “Substantial
Progress” means DAEWOONG has already submitted an
application for (NDA equivalent) the Markeing Authorization in
affected countries outside of the Territoy within 6
months. Further, STOCOSIL will have an automatic right
to exercise the Step-In right even without a written notice from
DAEWOONG, if DAEWOONG has not obtained the Marketing Authorizations
in the country(ies) outside of the Territory for the Product within
two years an approved US FDA Marketing Authorization for the
Optional Product by STOCOSIL. Not withstanding the above
statement, DAEWOONG will have an unlimited timeline to Develop and
Commercialize the Product and the Optional Product in Korea, China,
Vietnam, Indonesia, Thailand, and Philippines without triggering
the automatic Step-In right by STOCOSIL.
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7. NON-COMPETE
7.1
Neither
Party shall Develop and Commercialize any Competiting Product with
the Territory.
7.2
Further,
neither party shall Develop and Commercialize any Competing Product
within the Territory during the terms of this Agreement and three
years thereafter the termination and/or expiration of this
Agreement.
8. SUPPLY,
MANUFACTURING AND DELIVERY
8.1
Manufacture and supply of Products for
Development
8.1.1
Subject
to the terms and conditions determined in the relevant Development
Plan, DAEWOONG shall Manufacture or have Manufactured all
quantities of the Product required by STOCOSIL for use in the
course of Development of the Product. Without limiting
the generality of the foregoing, DAEWOONG shall (subject to the
relevant Development Plan):
(a)
Manufacture
(or have Manufactured) batches of the Product required for use in
Clinical Trials, bioavailability studies and bioequivalence studies
if necessary;
(b)
Manufacture
(or have Manufactured) suitable reference quantities of the Product
for the purposes of Clinical Trials, bioavailability studies and
bioequivalence studies (including any stability testing of the
Product that may be required in connection with the Development of
the Product);
(c)
Manufacture
(or have manufactured) any matching placebo required in connection
with a Clinical Trial of the relevant Product; and
(d)
Perform
any stability testing required in connection with the Development
of the Product.
8.1.2
DAEWOONG
shall perform the activities contemplated by Clause 8.1.1 at the
expenses of STOCOSIL. For
the avoidance of doubt, the expenses related in the Clause 8.1.1
will be added to the COGS of the Product for the purpose of
executing the Development Plan by STOCOSIL.
8.1.3
Any
Manufacture by DAEWOONG of the Product for Commercialization by
STOCOSIL in the Territory shall be governed by, and performed under
and in accordance with, the Manufacturing and Supply Agreement in
the Schedule 1.
8.1.4
DAEWOONG
shall supply the Product Manufactured pursuant to Clause 8.1.1 in a
form ready for clinical trial packaging. STOCOSIL shall
be responsible for clinical trial packaging and distribution of the
Product to investigator sites for any Clinical Trials.
8.1.5
DAEWOONG
shall only be obliged to Manufacture and supply the Product and/or
manufacture and supply matching placebo for Clinical Trials where
such Product and/or matching placebo is
Manufactured (or, as the case may be, manufactured) at its own
manufacturing site. For the avoidance of doubt, if
STOCOSIL requires that Clinical Trial supplies be Manufactured
(and/or, in the case of a matching placebo,
manufactured) at any non-DAEWOONG
manufacturing site, then STOCOSIL shall pay the costs of such
Manufacture (and/or manufacture) to the extent of the estimated
costs to DAEWOONG of Manufacturing the same Product (and/or
manufacturing the same matching placebo) in its own manufacturing
site and STOCOSIL shall be responsible for any incremental costs of
Manufacture (and/or, in the case of a matching placebo,
manufacture) over-and-above such estimated costs.
9.
PAYMENTS
9.1 Milestone
Payments
9.1.1 STOCOSIL
will pay DAEWOONG a milestone payment of US $500,000 upon
completion of the Clinical Trials and submission of NDA for the
Product with the US FDA.
9.1.2 STOCOSIL
will pay DAEWOONG a milestone payment of US $1,400,000 upon
obtaining an approval from the US FDA for the Product.
9.1.3 STOCOSIL
will pay DAEWOONG a milestone payment of US $3,000,000 upon
obtaining an approval from the US FDA for the Optional
Product.
9.1.4 Upon
executing this AGREEMENT, STOCOSIL will grant an unvested warrant
to DAEWOONG to purchase 500,000 shares of Stocosil Inc.’s
Corporate Common Stock (“Founders Shares”) for
$400.00. DAEWOONG will pay STOCOSIL $1.00 for the
unvested warrant. The unvested warrant will be vested
upon completion of the Clinical Trials and submission of NDA for
the Product with the US FDA by STOCOSIL. DAEWOONG will
have five (5) years to exercise its warrant to purchase the
Founders Shares once its warrant is vested. STOCOSIL
represents and warrants that it has legal authority and rights to
issue the Founders Shares and limit issuing the Founders Shares to
5,000,000 shares. These shares are subjected to the usual dilution
due to issuance of shares beyond the original 5,000,000 Founders
Shares for the purpose of financing. Accordingly,
DAEWOONG’s warrant is to purchase 10% of the total Founders
Shares already issued and/or to be issued. Once DAEWOONG
excercises its warrant, DAEWOONG agrees that the Founders Shares
may not be traded prior to 365 days after the effective date of the
registration statement filed by STOCOSIL Further,
STOCOSIL will register DAEWOONG’s Founders Shares if and when
Stocosil, Inc. registers shares of any class of equity shareholders
of Stocosil, Inc.
9.1.5 STOCOSIL
will pay DAEWOONG a milestone payment of US $1,000,000 upon
accumulation net sales of US $20,000,000 from the Product and
Optional Product.
9.2 Royalties
on Products
9.2.1 DAEWOONG
shall pay STOCOSIL five percent (5%) royalty on Net Sales of the
Productin Latin American countries where DAEWOONG will utilize
STOCOSIL’s Regulatory Documentation , clinical and Regulatory
Data and/or Dossier in order to obtain Marketing Authorization for
such country.
9.2.2
DAEWOONG
shall pay STOCOSIL seven percent (7%) royalty on Net Sales of the
Optional Product outside of the Territory including
Korea.
9.2.3 For
clarity, royalty payments under this Agreement are not based on
Patents or Trade Marks.
9.3 Accounting
Procedures
Both
Parties shall keep their financial records according to the
generally accepted accounting practices
(“GAAP”). STOCOSIL will follow the US GAAP,
and DAEWOONG will follow the Korean GAAP.
9.4 Records
Each
Party shall keep (and shall ensure that its Affiliates shall keep)
such records as are required to determine, in a manner consistent
with applicable accountancy practices and this Agreement, the sums
or credits due under this Agreement, including Development Costs,
COGS, Net Sales, net profits, and net losses. All such
books, records and accounts shall be retained by such Party until
the later of (a) three (3) years after the end of the period to
which such books, records and accounts pertain and (b) the
expiration of the applicable tax statute of limitations (or any
extensions thereof), or for such longer period as may be required
by Applicable Law.
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9.5 Audits
Each
party will have the right, upon forty-five (45) days prior written
notice and during normal business hours, through an independent
third party representative (who will agree to be bound by
confidentiality provisions to review and inspect the other party's
books and records which relate to such other parties's operations
under this Agreement including, but not limited to, records
concerning Commercial Sales, Net Sales, Product Development Costs,
sales presentations, and other costs. An inspection
shall not occur more than once in any consecutive two calendar
years. The party whose records are being inspected may designate
competitively sensitive information which the representative may
not disclose to the other party, provided, however, that such
designation shall not encompass the representative's conclusions.
Such representative shall only report inaccuracies in amounts
payable under this Agreement. With respect to inspection of
STOCOSIL’s or designated Affiliate books and records,
DAEWOONG may request that an independent auditor familiar with
STOCOSIL record keeping systems be present at the inspection to
assist DAEWOONG auditor in using STOCOSIL’s internal record
management system. Likewise, with respect to inspection of DAEWOONG
books and records, STOCOSIL may request that an independent auditor
familiar with DAEWOONG's record keeping systems be present at the
inspection to assist STOCOSIL auditor in using DAEWOONG's internal
record management system. Each party shall bear the costs and
expenses of its representative for inspections conducted under this
Section, unless a variation or error producing an underpayment in
amounts payable exceeding 5% of the amount paid for any period
covered by the inspection is established in the course of any such
inspection, whereupon all costs relating to the inspection for such
period and any unpaid or overpaid amounts that are discovered will
be paid or credited as appropriate by the party in whose favor the
deviation occurred. When a variation or error producing an
underpayment in amounts payable exceeding 5% of the amount paid for
any period covered by the inspection, such underpayment will be
treated as late payment and will be handled according to the Clause
9.6.8. This Section will survive the expiration or the
termination of the Agreement for a period of two (2)
years.
9.6 General
Payment Terms
9.6.1
STOCOSIL
shall pay each milestone payment within 30 days of each vesting
milestone event.
9.6.2
STOCOSIL
is required to open a LC prior to the shipment and the payment will
be made from the bank on the 45th
day or within 45 days of the shipment.
9.6.3
DAEWOONG
will pay appropriate royalty payments within 45 days of each
Calendar Quarter.
9.6.4
During
the Term, DAEWOONG shall furnish to STOCOSIL a written report
within forty-five (45) days after the end of each Calendar Quarter
showing (i) Net Sales during such Calendar Quarter, (ii) the
calculation of royalties for such Calendar Quarter, (iii)
withholding taxes, if any, required by Applicable Law to be
deducted (the “Royalty
Report”).
9.6.5
Payments
under this Agreement made by a Party (the “Payor”) to the
other Party (the “Payee”) shall be
made in US Dollar and shall be effected by immediate bank transfer
into such account as may be designated by the Payee to the Payor by
notice in writing. All costs, bank charges or
other related fees shall be borne by the Payor.
9.6.6
Any
tax paid or required to be withheld by the Payor for the benefit of
the Payee on account of any payments payable to the Payee under
this Agreement shall be deducted from the amount of royalties or
other payments otherwise due. The Payor shall secure and
send to the Payee proof of any such taxes withheld and paid by the
Payor for the benefit of the Payee, and shall, at the Payee’s
request, provide reasonable assistance to the Payee in claiming
exemption from such deductions or withholdings under any applicable
double taxation or similar agreement or treaty.
9.6.7
All
amounts referenced under this Agreement are exclusive of any VAT or
similar taxes and payments hereunder shall be made without
deduction for such taxes. Accordingly, if any VAT or
similar tax is due with respect to such a payment, such tax shall
be payable in addition to the amounts set out under this
Agreement.
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9.6.8
Any
payments or portions thereof due under this Agreement which are not
paid when due shall bear interest equal to the lesser of the
average one-month London Inter-Bank Offering Rate (LIBOR) for
Pounds Sterling, as reported in the Financial Times, on the due
date (or, if the due date is not a Business Day, on the last
Business Day prior to such due date), or the maximum rate permitted
by applicable law, in each case calculated on the number of days
such payment is delinquent. This Clause 9.6.8 shall in
no way limit any other remedies available to either
Party. Notwithstanding the foregoing: (a) in the event
that any payment, or portion thereof, is disputed in good faith by
the debtor, any subsequent settlement payment related to that
dispute shall not include interest thereon; and (b) the Party due
to make such payment shall not be liable to pay interest in the
event that: (i) any payments are disputed or subject to resolution
of interpretation of the terms hereof; (ii) payment has been
delayed for reasons without the control of the Party due to receive
payment (including without limitation due to invalid or late
changes to bank details and non-compliant invoices); and (iii) the
Party due to receive payment has not responded to genuine questions
or queries from the Party due to make payment.
9.6.9
If
any currency conversion shall be required in connection with the
calculation of amounts payable hereunder, such conversion shall be
made using the average exchange rates as calculated and utilised by
the Payor’s group reporting system and as consistently
applied in its external reporting. As of the date of
this Agreement, the method utilised by STOCOSIL’s group
reporting system uses spot exchange rates sourced from
Reuters/Bloomberg and, if such method is changed during the term of
this Agreement, STOCOSIL will provide the DAEWOONG with written
notice of the revised method.
10. INTELLECTUAL
PROPERTY RIGHTS
10.1 Ownership
of Intellectual Property Rights
10.1.1 Each
Party shall own all inventions created solely by its or its
Affiliates employees during the conduct of the collaboration under
this Agreementand shall jointly own all Inventions jointly invented
by employees of DAEWOONG and/or its Affiliates on the one hand and
STOCOSIL and/or its Affiliates on the other. The
inventorship shall be determined in accordance with United States
patent laws. To clarify, inventorship and assignment of inventions
will be accord to those who conceived the
invention. STOCOSIL will be aggressively pursue patent
protection for the Product and Optional Product aacording to the US
Patent and Inventorship laws.
10.1.2 STOCOSIL
will have exclusive ownership to any and all STOCOSIL Arising
IP. DAEWOONG acknowledges that all right, title and
interest in STOCOSIL Arising IP, STOCOSIL Background IP,
STOCOSIL’s Confidential Information, all inventions and
improvements which use, reference or relate to TDM, STOCOSIL
Background IP, STOCOSIL’s Confidential Information, shall
remain the sole property of STOCOSIL. DAEWOONG will have
exclusive ownership to any and all DAEWOONG Arising
IP. STOCOSIL acknowledges that all rights, title and
interest in DAEWOONG Arising IP shall remain the sole property of
DAEWOONG.
10.1.3 At
the request of STOCOSIL, and with further payment of the
reimbursement of its reasonable costs, DAEWOONG shall execute, and
(if required) shall procure that its agents, Employees and
contractors shall execute, any such assignment or other document as
may be necessary or desirable or required by STOCOSIL (or its
nominee) to perfect the vesting and assignment of STOCOSIL Arising
IP.
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10.2 Maintenance
and Patent Prosecution
10.2.1 DAEWOONG
shall be responsible for preparing, filing, prosecuting and
maintaining all DAEWOONG Background IP which are relevant to any
Product. DAEWOONG shall consult with STOCOSIL and
consider in good faith any input from STOCOSIL with respect to such
preparation, filing, prosecution and maintenance. If
DAEWOONG chooses not to proceed with the prosecution or maintenance
of any DAEWOONG Background IP, STOCOSIL shall have the option, but
not the obligation, to require an assignment of the relevant
DAEWOONG Background IP from DAEWOONG to it.
10.2.2 STOCOSIL
shall be responsible for preparing, filing, prosecuting and
maintaining all STOCOSIL Background IP which are relevant to any
Product. STOCOSIL shall consult with DAEWOONG and
consider in good faith any input from DAEWOONG with respect to such
preparation, filing, prosecution and maintenance. If
STOCOSIL chooses not to proceed with the prosecution or maintenance
of any STOCOSIL Background IP, subject to approval by the Joint
Steering Committee, DAEWOONG shall have the option, but not the
obligation, to require an assignment of the relevant STOCOSIL
Background IP from STOCOSIL to it.
10.2.3 STOCOSIL
shall be responsible for preparing, filing, prosecuting and
maintaining of all STOCOSIL Arising IP created during the
collaboration under this Agreement owned solely by
STOCOSIL. STOCOSIL shall consult with DAEWOONG and
consider in good faith any input from DAEWOONG with respect to such
preparation, filing, prosecution and maintenance. If
STOCOSIL chooses not to proceed with the prosecution or maintenance
of any STOCOSIL Arising IP, subject to approval by the Joint
Steering Committee, DAEWOONG shall have the option, but not the
obligation, to require an assignment of the relevant STOCOSIL
Arising IP from STOCOSIL to it.
10.2.4 DAEWOONG
shall be responsible for preparing, filing, prosecuting and
maintaining of DAEWOONG Arising IP created during the collaboration
under this Agreement owned solely by DAEWOONG. DAEWOONG
shall consult with STOCOSIL and consider in good faith any input
from STOCOSIL with respect to such preparation, filing, prosecution
and maintenance. If DAEWOONG chooses not to proceed with
the prosecution or maintenance of any DAEWOONG Arising IP, subject
to approval by the Joint Steering Committee, STOCOSIL shall have
the option, but not the obligation, to require an assignment of the
relevant DAEWOONG Arising IP from DAEWOONG to it.
10.2.5 In
respect of inventions created during the collaboration under this
Agreement owned jointly by DAEWOONG and STOCOSIL
(“Joint
IP”), the Senior Representatives of both Parties shall
decide who shall be responsible for preparing, filing, prosecuting
and maintaining all Patent applications and patents relating
thereto. The Party responsible shall consult with the other Party
and consider in good faith any input from the other Party with
respect to such preparation, filing, prosecution and
maintenance. If the Party responsible chooses not to
proceed with the prosecution or maintenance of any Intellectual
Property Rights, subject to approval by the Steering Committee, the
other Party shall have the option but not the obligation to require
an assignment of the relevant Intellectual Property Rights from the
Party responsible to the other Party.
10.2.6 STOCOSIL
shall have the first right, but not the obligation, to enforce and
defend any claims arising under or in respect of STOCOSIL
Background IP, STOCOSIL Arising IP and/or Joint IP, at its own cost
and control. STOCOSIL will consult with DAEWOONG on such
enforcement or defence strategy and keep DAEWOONG fully informed on
the progress thereof. In the event that STOCOSIL elects
not to pursue any infringer of the foregoing intellectual property
rights in any country where STOCOSIL has decided not to
Commercialize the relevant Product under the terms of this
Agreement and DAEWOONG has decided to Commercialize, DAEWOONG shall
have the right, but not the obligation, to enforce and defend such
right where it is legally permitted to do so. The Party
bringing action under this Clause 11.2.6 shall be entitled to
recover its legal costs from any recoveries or remedies arising
from such litigation, after which 75 per cent of the balance of any
recoveries or remedies shall be retained by the Party bringing the
action with the remaining amount being paid to the other
Party.
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10.2.7 DAEWOONG
shall have the first right, but not the obligation, to enforce and
defend any claims arising under or in respect of DAEWOONG
Background IP and/or DAEWOONG Arising IP, at its own cost and
control. DAEWOONG will consult with STOCOSIL on such
enforcement or defence strategy and keep STOCOSIL fully informed on
the progress thereof. In the event that DAEWOONG elects
not to pursue any infringement of the foregoing intellectual
property rights in any country where STOCOSIL is Commercializing
the relevant Product under the terms of this Agreement, STOCOSIL
shall have the right, but not the obligation, to enforce and defend
such right where it is legally permitted to do so. The
Party bringing action under this article 11.2.7 shall be entitled
to recover its legal costs from any recoveries or remedies arising
from such litigation, after which 75 per cent of the balance of any
recoveries or remedies shall be retained by the Party bringing the
action with the remaining amount being paid to the other
Party.
10.2.8 STOCOSIL
shall be responsible for defending at its own cost and control
against third party claims of infringement of that third
party’s patent with respect to the Product in any country in
the Territory where STOCOSIL chooses to register and market that
Optional Product. Each Party is responsible for defending at its
own cost and control against Third Party claims of infringement of
that Third Party’s patent(s) with respect to the
Product. To clarify, DAEWOONG is responsible for defense
against Third Party claims of infringement by DAEWOONG Product-
namely Olostar; STOCOSIL is responsible for defense against Third
Party claims of infringement by STOCOSIL Product- namely TDM device
and/or TDM Device/Drug combination for treatment of
resistant-HTN.
10.2.9 DAEWOONG
and STOCOSIL shall discuss in good faith patent term extensions and
the listing of patents in the FDA Orange Book and related options
or obligations in other countries.
10.3 Trade
Marks
10.3.1 Selection,
Maintenance and Prosecution of the STOCOSIL Trade
Marks
10.3.1.1 STOCOSIL
shall be responsible for the selection, registration, defense and
maintenance of the STOCOSIL Trade Marks under which STOCOSIL will
market all Products and/or Optional Product in the Territory, as
well as all expenses associated therewith. STOCOSIL
shall own all STOCOSIL Trade Marks and any domain names
incorporating such STOCOSIL Trade Marks used by STOCOSIL in
connection with the Development, Manufacturing and
Commercialization of Products and/or Optional Product under this
Agreement and all goodwill associated therewith, DAEWOONG shall not
have, assert or acquire any right, title or interest in or to any
of the STOCOSIL Trade Marks. In the event that DAEWOONG
acquires any rights in the STOCOSIL Trade Marks in connection with
DAEWOONG’s activities pursuant to this Agreement, DAEWOONG
will assign, and hereby does assign, to STOCOSIL or
STOCOSIL’s Affiliates all such rights, including any related
goodwill.
10.3.1.2
STOCOSIL (or its Affiliate) shall have the sole right to enforce
and defend for the STOCOSIL Trade Marks in the Territory, including
(a) defending against any alleged, threatened or actual claim by a
Third Party that the use of the STOCOSIL Trade Marks infringes,
dilutes or misappropriates any Trademark of that Third Party or
constitutes unfair trade practices or any other like offense, or
any other claims as may be brought by a Third Party against a Party
in connection with the use of or relating to any STOCOSIL’S
Trade Xxxx with respect to the Product and/or Optional Product, and
(b) taking such action as STOCOSIL deems necessary against a Third
Party based on any alleged, threatened or actual infringement,
dilution or misappropriation of, or unfair trade practices or any
other like offense relating to, any STOCOSIL’S Trade Xxxx by
a Third Party. Any costs and expenses allocable to an enforcement
action or defense commenced pursuant to this Clause shall be at
STOCOSIL expense.
10.3.1.3 DAEWOONG shall
not at any time during the Term do, or knowingly allow to be done,
any act or thing which will in any way impair or diminish the
rights of STOCOSIL in or to the STOCOSIL Trade Marks which are used
by DAEWOONG pursuant to this Agreement. All
goodwill and improved reputation generated by DAEWOONG’s use
of the STOCOSIL Trade Marks shall inure to the benefit of STOCOSIL,
and any use of the STOCOSIL Trade Marks by DAEWOONG shall cease at
the end of the Term.
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10.3.1.4 DAEWOONG
will not contest the ownership of the STOCOSIL Trade Marks, their
validity, or the validity of any registration therefor during the
Term or thereafter. Each Party undertakes not to have
registered and/or not to use any marks that are confusingly similar
to the marks of the other Party used pursuant to this Agreement
(including, in the case of STOCOSIL, the STOCOSIL Trade Marks and,
in the case of DAEWOONG, the DAEWOONG Trademarks).
11. CONFIDENTIALITY
AND PUBLICATIONS
11.1 Confidentiality
11.1.1 Each
Party shall maintain Confidential Information as confidential at
all times, and shall:
(a)
keep confidential all such Confidential Information of the other
Party (the “Protected Party”) and shall not (except as
expressly permitted by this Agreement or by the Protected Party in
writing) disclose such Confidential Information, make copies of
material, media or software containing such Confidential
Information or otherwise use such information except as permitted
pursuant to this Agreement;
(b)
safeguard such Confidential Information and comply with any
reasonable security requirements specified by the Protected Party
from time to time, including, where STOCOSIL is the Protected
Party;
(c)
implement rigorous security practices against any unauthorised
copying, use, disclosure, access, alteration, damage, destruction
or loss of such Confidential Information;
(d)
immediately notify the Protected Party if it suspects or becomes
aware of any unauthorised copying, use, disclosure, access, damage,
destruction or loss in any form of any of such Confidential
Information;
(e)
take all reasonable steps to enforce against any Third Party (and
to assist the other Party to so enforce) any obligation of
confidence imposed or required to be imposed by this Agreement;
and
(f)
do all things, execute all documents and give all assistance
reasonably required by the Protected Party to enforce any
obligation of confidence imposed or required to be imposed by this
Agreement.
11.1.2 Nothing
in this Agreement shall prohibit the use, copying or disclosure by
DAEWOONG or STOCOSIL, as the case may be, to the extent
that:
(a)
such
Confidential Information has been placed in the public domain other
than through such Party’s fault or that of a person who was
provided with the information by such Party;
(b)
such
Confidential Information has been independently developed by such
Party or its Affiliates without reference to the protected
Party’s Confidential Information;
(c)
the
other Party has approved in writing the particular use or
disclosure of such Confidential Information;
(d)
such
Confidential Information is already known by such Party without an
obligation of confidentiality;
(e)
such
Confidential Information is independently or rightfully received
from a Third Party without any obligation of confidence;
or
(f)
such
disclosure is expressly required by law or otherwise by any
relevant stock exchange or national or supranational governmental
or Regulatory Body or court entitled by law to disclosure of the
same, but only to the extent of or for the purpose of such demand
or order, provided that such Party:
(i) uses
Commercially Reasonable Efforts to minimise any such disclosure or
to assist the other Party to prevent or restrict the
disclosure;
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(ii)
gives
the other Party prompt notice of such requirement to disclose to
enable the other Party to seek an appropriate protective order;
and
(iii)
uses
Commercially Reasonable Efforts to require the recipient of such
Confidential Information to preserve the confidential nature of
such Confidential Information once disclosed.
11.1.3 Each
Party shall treat the negotiations and the terms of this Agreement
as Confidential Information and only use and disclose them in
accordance with this Clause.
11.1.4 The
obligations with respect to Confidential Information disclosed
under this Agreement shall survive the expiry or termination (for
whatever reason) of this Agreement and continue for as long as such
information remains Confidential Information.
11.1.5 Upon
termination of this Agreement, in accordance with Clause 18, either
Party may request the other to promptly return all or any specified
part of the Confidential Information, all physical and written
records containing or relating to the other Party’s
Confidential Information. If requested by a Party, the other Party
shall destroy or delete the Confidential Information in the manner
specified by such Party promptly certify to the other Party in
writing that it has done so, provided always that STOCOSIL shall
not be required to return any part of DAEWOONG Confidential
Information which STOCOSIL, and/or the Third Party are licensed or
otherwise permitted to use after the termination date pursuant to
this Agreement.
11.1.6 The
Parties acknowledge that the breach of this Clause 11 by a Party
may cause the other Party irreparable injury for which it would not
have an adequate remedy at law. In the event of a
breach, the non-breaching Party may be entitled to injunctive
relief in addition to any other remedies it may have at law or in
equity.
11.1.7
DAEWOONG
may use its Confidential Information outside the scope of this
Agreement without restriction. STOCOSIL may use its
Confidential Information outside the scope of this Agreement
without restriction.
11.2 Patient
Information
The
Parties agree to abide (and to cause their respective Affiliates to
abide), and to take (and to cause their respective Affiliates to
take) all reasonable and appropriate actions to ensure that all
Third Parties conducting or assisting with any clinical development
activities hereunder in accordance with, and subject to the terms
of, this Agreement, shall abide, to the extent applicable, by all
Applicable Law concerning the confidentiality or protection of
patient identifiable information and other patient’s
protected health information, including data protection regulations
within the Territory and outside of the Territory, in the course of
their performance under this Agreement.
11.3
Publications
11.3.1 Neither
Party or its Affiliates shall during the Term of this Agreement
publish or publicly disclose the results of the Development
activities conducted under this Agreement, without the prior
written consent of the other Party, except as permitted in this
Clause 11.3.1 and Clause 14.2 or otherwise required by Applicable
Laws. The
Parties recognize that it may be useful or required to publish or
publicly disclose the results of research and development work on
any Product, and each Party (and its Affiliates and sublicensees)
shall be free to publish or publicly disclose such results, subject
to the prior review by the other Party for patentability and
protection of its Confidential Information and subject to
compliance with STOCOSIL’s Global Scientific Engagement as
communicated to DAEWOONG from time to time. The Party
that desires to publish such results hereunder shall provide to the
other Party a copy of such proposed abstract, manuscript, or
presentation no less than thirty (30) Business Days prior to its
intended submission for publication in the case of a manuscript and
five (5) Business Days for other publications. DAEWOONG
shall submit the proposed abstract, manuscript or presentation to
STOCOSIL by such means as STOCOSIL may specify in writing to
DAEWOONG. The reviewing Party shall respond in writing
promptly and in no event later than twenty (20) Business Days after
receipt of the proposed material in the case of a manuscript and
three (3) Business days for other publications, with one or more of
the following: (i) comments on the proposed material, which the
publishing Party shall consider in good faith but have no
obligation to accept; (ii) a specific statement of concern, based
upon the need to seek patent protection or compliance with
STOCOSIL’s principles and operating
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standards
on scientific engagement; or (iii) an identification of the
reviewing Party’s Confidential Information that is contained
in the material reviewed. In the event of concern over
patent protection, the publishing Party agrees not to submit such
publication or to make such presentation that contains such
information until the reviewing Party is given a reasonable period
of time (not to exceed a further forty five (45) Business Days) to
seek patent protection for any material in such publication or
presentation which it believes is patentable or to resolve any
other issues. Each Party shall ensure that any
manuscript published in accordance with this Clause 11.3.1 shall in
any event comply with the International Committee of Medical
Journal Editors Uniform Requirements for Manuscripts Submitted to
Biomedical Journals. Any Confidential Information of
such other Party shall be removed.
11.4 Announcements
11.4.1 The
Parties shall not make or issue any public announcement, circular
or disclosure in connection with the existence or the subject
matter of this Agreement without the prior written approval of the
other Party, such approval not unreasonably to be delayed or
withheld.
11.4.2 The
restriction in Clause 11.4.1 shall not apply to the extent that
announcement or disclosure is required by law or by any stock
exchange, governmental or other regulatory or supervisory body or
authority of competent jurisdiction to whose rules the Party making
the announcement or disclosure is subject, whether or not having
the force of law. Where any announcement or disclosure
is made in reliance on this exception:
(a)
the
Party making the announcement or disclosure shall use its
Commercially Reasonable Efforts to consult with the other Party in
advance as to the form, content and timing of any such announcement
or disclosure and shall take reasonable account of the other
Party’s views;
(b)
the
announcement or disclosure shall contain the minimum (and no more
than the minimum) necessary to comply with the relevant
requirements; and
(c)
such
party shall have been advised by its external legal counsel that
such announcement or disclosure is necessary to comply with the
relevant requirements.
12. PHARMACOVIGILENCE
AND PRODUCT RECALLS
12.1
Pharmacovigilence
12.1.1
STOCOSIL
shall be responsible for worldwide pharmacovigilance and will hold
the Global Safety Data Sheet of the Product and Optional
Product. STOCOSIL will bear the pharmacovigilance
costs.
12.1.2
All
Phase II and Phase III Clinical Trials related to the Product and
Optional Product will require STOCOSIL’s Global Safety Board
approval.
12.1.3
Subject
to the terms of this Agreement, as soon as practicable following
the Effective Date, STOCOSIL and DAEWOONG (under the guidance of
their respective pharmacovigilance departments, or equivalent
thereof) shall identify and finalize the responsibilities the
Parties shall employ to protect patients and promote their
well-being in a separate Safety Data Exchange Agreement
(“SDEA”). These
responsibilities shall include mutually acceptable guidelines and
procedures for the receipt, investigation, recordation,
communication and exchange (as between the Parties) of safety
information such as Adverse Events, pregnancy exposure, lack of
efficacy, misuse/abuse, and any other information concerning the
safety of the Product. Such guidelines and procedures
will be in accordance with, and enable the Parties and their
Affiliates to fulfill, local and international regulatory reporting
obligations to government authorities and other applicable Laws.
Furthermore, such agreed procedures shall be consistent with
relevant FDA and International Council for Harmonization (ICH)
guidelines, except where said guidelines may conflict with existing
local regulatory safety reporting requirements, in which case local
reporting requirements shall prevail. The SDEA shall
provide that: (i) STOCOSIL shall be responsible for all
pharmacovigilance activities regarding the Product, including
signal detection, medical surveillance, risk management, global
medical literature review and monitoring, Adverse Event reporting
and responses to regulatory authority requests or medical
information enquiries and (ii) in the event DAEWOONG receives
safety information regarding the Product, or information regarding
any safety-related regulatory request or inquiry, DAEWOONG shall
promptly notify STOCOSIL, but in no event later than three (3)
Business Days, after it receives such safety information,
regulatory authority request or query.
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12.1.4
Medical
Information. STOCOSIL shall respond to all reasonable
requests for medical information. Promptly after the
Effective Date, the Parties shall establish procedures in
accordance with the applicable portions of STOCOSIL’s
processes and standard operating procedures, to enable DAEWOONG to
send such requests to specific parties to enable prompt response to
any medical inquiries.
12.1.5
Product
Withdrawals and Recalls. In the event that
either Party (a) becomes aware of an event, incident or
circumstance that has occurred which may result in the need for a
recall or other removal of the Product or any lot or lots thereof
from the market; (b) becomes aware that a Regulatory Authority is
threatening or has initiated an action to remove the Product from
the market; (c) is required by any Regulatory Authority to
distribute a “Dear Doctor” letter or its equivalent,
regarding use of the Product; or (d) places a clinical trial for a
Product on hold for clinical safety reasons, such Party shall
promptly advise the other Party in writing with respect thereto,
and shall provide to such other Party copies of all relevant
correspondence, notices, and the like. The holder of the
Marketing Authorization (if any) for the Product shall have final
authority to make all decisions relating to any recall, market
withdrawal or other corrective action with respect to the Product
in the jurisdiction covered by that Marketing Authorization and
shall be responsible for conducting any recalls or taking such
other remedial action, and each Party agrees, upon reasonable
request by the Marketing Authorisation holder and at the expense of
the Marketing Authorization holder, to assist with respect to such
recalls or remedial actions. STOCOSIL shall have final
authority to make all decisions relating to any recall, withdrawal
or other corrective action with respect to the Product in use in a
Clinical Trial, and DAEWOONG agrees, upon reasonable request and
notice by STOCOSIL and at the expense of STOCOSIL, to assist with
respect to such recall, withdrawal or other corrective
action.
12.1.6
In
the event that (i) any recall, market withdrawal or other
corrective action is (or may be) required in relation to the
Product Manufactured and supplied by DAEWOONG to STOCOSIL pursuant
to the Manufacturing and Supply Agreement and (ii) there is any
conflict or inconsistency between the provisions of that
Manufacturing and Supply Agreement and the provisions of Clause
12.1.6, the provisions of the Manufacturing and Supply Agreement
shall, to the extent of such inconsistency or conflict,
prevail.
13. MEDICAL
GOVERNANCE
13.1
It
is agreed that where in a clinical study relating to the
Product:
(a)
the
route of administration is to be changed;
(b)
patient
exposure is designed to be significantly increased beyond that of
the originator molecules; and/or
(c)
there
is a high risk of drug on drug interactions (as assessed by
STOCOSIL), no clinical studies shall be undertaken,
prior
to commencement, such study shall be submitted to STOCOSIL’s
Global Safety Board for review and comment.
13.2
In
the event that the Parties do not agree with the comments of
STOCOSIL’s Global Safety Board made following a referral to
it under Clause 13.1, the decision as to whether the Clinical Trial
in question shall proceed and on what terms shall be made in
accordance with the provisions set out in Clause 4.2.
13.3
The
Parties agree at all times to comply with the Global Scientific
Principles and Standards and that in particular any publicity and
marketing relating to the Products shall comply with such
principles and standards.
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14. CLINICAL
TRIALS
14.1
Conduct of Clinical Trials
14.1.1
STOCOSIL
shall be responsible for conducting and funding, in its sole
direction, all Phase III Clinical Trials for the Product and/or
Optional Product in the Territory.
14.1.2
Unless
otherwise agreed by the Parties or required by Applicable Law,
STOCOSIL shall own all data and reports related to Clinical Studies
in the Territory. All data, database information
and safety reports from such Clinical Trials in the Territory for
the Product and/or Optional Product shall be centralised and held
by STOCOSIL with copies of such data, information or reports
provided to DAEWOONG to the extent required as contemplated in this
Agreement or the Development Plan to support application for
Marketing Authorization outside of the Territory.
14.2
Clinical Trial Registry
14.2.1
To
the extent required by Applicable Laws, STOCOSIL shall have the
right at any time during and after the term of this Agreement to
publish the results or summaries of results of all clinical trials
conducted with respect to the Product and/or Optional Product in
any clinical trial register maintained by STOCOSIL or its Affiliate
and the protocols of clinical trials relating to such Product
and/or Optional Product on xxx.XxxxxxxxXxxxxx.xxx and/or in each
case publish the results, summaries and/or protocols of clinical
trials on such other websites and/or repositories and in a
peer-reviewed journal within such timescales as required by law or
STOCOSIL’s or its Affiliate’s standard operating
procedures, irrespective of the outcome of such clinical
trials. Each such publication made in accordance with
this Clause 14 shall not be a breach of the applicable
confidentiality obligations set out in the Agreement and STOCOSIL
shall be entitled to maintain such publication even following any
termination of STOCOSIL’s rights in respect of the relevant
Product and/or Optional Product.
14.2.2
DAEWOONG
shall have the right to publish the results or summaries of results
of all Clinical Trials conducted with respect to the Product and/or
Optional Product outside of the Territory as allowed by Applicable
Laws. Prior to public disclosure or submission for
publication of a proposed publication describing the results of any
scientific or clinical activity relating to the Product and
Optional Product outside of the Territory, DAEWOONG shall send
STOCOSIL by expedited delivery a copy of the proposed publication
to be submitted and shall allow STOCOSIL a reasonable time period
(but no more than sixty (60) days from the date of confirmed
receipt) in which to determine whether the proposed publication
contains subject matter for which patent protection should be
sought (prior to publication of such proposed publication) for the
purpose of protecting an invention, or whether the proposed
publication contains Confidential Information of
STOCOSIL. Following the expiration of applicable time
period for review, DAEWOONG shall be free to submit such proposed
publication for publication and publish or otherwise disclose to
the public such scientific or clinical results.
15. REPRESENTATIONS
AND WARRANTIES
15.1 General
Warranty.
Each
Party warrants to the other that:
(a)
it has the necessary right and authority to enter into this
Agreement and that to the best of its knowledge the
execution, performance and delivery of this Agreement will not
conflict with any obligation to which any of the Parties is
subject;
(b)
it
is carrying on its business in compliance with all Applicable
Laws.
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15.2 Background
IP.
Each
Party hereby represent and warrants that:
(a)
it
has the title and/or right its Background IP and Know-How in
relation to the Product and Optional Product and further that it
has the title and/or right to grant the other the right to use such
Background IP in accordance with the terms of this
Agreement;
(b)
to
the best of its knowledge and reasonable belief as of the Effective
Date there is no claim or litigation pending, or, threatened,
concerning any infringement or alleged infringement of any Third
Party’s valid and enforceable Intellectual Property Rights in
relation to the Development, Manufacture or Commercialization of
the Product and/or Optional Product.
15.3 DAEWOONG
hereby represents and warrants to
STOCOSIL that:
(a)
the
manufacturing site and all equipment, tooling and moulds utilized
in the performance of the Development of the Product hereunder by
DAEWOONG shall, during the Term of this Agreement, be maintained in
good operating condition and shall be maintained and operated in
accordance with all Applicable Laws. The Manufacturing
and storage operations, procedures and processes utilized in the
Development and Manufacture and supply of the Products hereunder
shall be in full compliance with all Applicable Laws, including
GLP, GCP and cGMP and health and safety laws as
necessary;
(b)
it
shall perform all of its obligations under this Agreement in full
compliance with all Applicable Laws, including but not limited to
those laws and regulations applicable to DAEWOONG’s
environment, health and safety guidelines;
(c)
all
Waste, including but not limited to all Hazardous Waste, generated
shall be disposed of in accordance with all Applicable Laws and
regulations governing such matters in the Territory;
(d)
it
shall hold during the Term of this Agreement all licences
(including any Manufacturing Licence), permits and similar
authorizations required by statutory authority and any other
Regulatory authority to perform its obligations under this
Agreement;
(e)
the
Product supplied to STOCOSIL under this Agreement shall be produced
and delivered in accordance with and shall be of the quality
specified in and shall conform to, the Specifications, the Quality
Agreement and Applicable Laws including, without limitation, GCP,
GLP and GMP, and any other quality assurance requirements of
STOCOSIL;
(f)
it
is able to pass good title to the API or Product supplied to
STOCOSIL pursuant to this Agreement;
(g)
the
Product will not contain any Materials that has not been used,
handled or stored in accordance with the relevant Quality
Agreement, all Applicable Laws and any other quality assurance
requirements of STOCOSIL;
(h)
DAEWOONG
shall at all times be responsible for all the DAEWOONG employees
operating within its Manufacturing Site and all obligations with
respect to such DAEWOONG employes(s) shall be discharged by
DAEWOONG at its own cost without reference to STOCOSIL. It is
hereby clarified that at no time shall STOCOSIL be deemed to have
any nexus or responsibility towards the employee(s) of DAEWOONG;
and
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(i) it
has never been and is not currently (i) an individual who has been
debarred by the FDA pursuant to 21 U.S.C. 335a(a) or (b) from
providing services in any capacity to a person that has an approved
or pending drug product application, or an employer, employee or
partner of such a debarred individual; or (ii) a corporation,
partnership or association that has been debarred by FDA pursuant
to 21 U.S.C. 335a(a) or (b) from submitting or assisting in the
submission of a drug application, or a partner , shareholder,
member, subsidiary, or Affiliate of a debarred entity. DAEWOONG has
no reason to believe that any circumstances exist which may affect
the accuracy of the foregoing representation, including without
limitation any FDA investigations of, or debarment proceedings
against Supplier or any other person or entity performing services
or rendering assistance, which is in any way related to activities
to be undertaken pursuant to this Agreement. DAEWOONG
shall immediately notify STOCOSIL in writing if DAEWOONG at any
time during the Term of this Agreement, becomes aware of any such
circumstances;
15.4 Environmental
warranties and compliance
(a)
DAEWOONG
represents and warrants that to the best of its knowledge as of the
Effective Date of this Agreement, there is no pending or likely
governmental enforcement action or private claim against DAEWOONG
regarding environmental matters that are reasonably likely to
limit, impede or otherwise jeopardize DAEWOONG’s ability to
meet its obligations under this Agreement;
15.5 DAEWOONG
hereby represents and warrants to STOCOSIL that:
(a)
the
Product supplied hereunder shall conform to the Specifications and
the requirements of the Marketing Authorisations relating
thereto;
(b)
the
Product shall be Manufactured, quality controlled and packed in
accordance with relevant GCP, GLP and cGMP, the Quality Agreement
and Applicable Laws.
(c)
it
will convey good title to the Product supplied
hereunder;
(d)
it
holds all necessary consents, authorizations, registrations,
certificates, licences, approvals, permits, authorities or
exemptions from any regulatory authority which are required to
perform its obligations under this Agreement and has paid all fees
due in relation to them and is not in breach of any conditions
under them where such breach would be likely to have a material and
adverse effect on its ability to perform its obligations under this
Agreement;
(e)
to
the best of its knowledge it is not subject to any material
administrative or governmental investigations, in respect of the
Products and including without limitation any such investigation in
relation to any Manufacturing Site; and
(f)
as
at the date of this Agreement other than as disclosed to STOCOSIL
in writing to the best of its knowledge there is no claim or
litigation pending or threatened, concerning any infringement or
alleged infringement of any third party’s registered
Intellectual Property including without limitation any granted or
pending patents or pending patent applications in relation to the
Manufacture, import, release after import, marketing, promotion,
distribution, sale and use of the Products, including under any
trade marks already submitted to any regulatory authority as part
of a Marketing Authorisation (or application relating thereto) in
relation to the Products and that the Manufacture, import, release
after import, marketing, promotion, distribution, sale and use
under this Agreement of such products will not infringe the
registered Intellectual Property rights of any third party
including without limitation any granted or pending patents or
pending patent applications and including in respect of the
proposed or actual use of any trade marks already submitted to any
regulatory authority as part of a Marketing Authorisation (or
application relating thereto) in relation to the
Products.
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15.6 Each
Party hereby undertakes that:
(a)
it
shall, and shall procure that its Affiliates and sublicensees
shall, observe all Applicable Laws, including the terms of the
relevant Marketing Authorizations, in relation to its
Commercialization of the Product and/or Optional Product in the
Territory and outside of the Territory; and
(b)
it
shall not, and shall procure that its Affiliates and sublicensees
shall not, make any false and/or misleading representation
regarding the Product and/or Optional Product.
The
liabilities of the Parties under this Clause 15 shall survive the
expiration or termination of this Agreement.
16. INDEMNITY
16.1
DAEWOONG
shall defend, indemnify and hold harmless STOCOSIL and its
Affiliates from and against any and all Liabilities and Losses that
may, respectively, be brought by a third party against, or be
suffered or incurred by, STOCOSIL and/or any of its Affiliates and
arising out of or in connection with:
(a)
any
breach of any representation or warranty made by DAEWOONG under
this Agreement;
(b)
any
third party personal injury, illness or death, or loss or damage to
third party property arising from DAEWOONG’s failure to
Manufacture and/or supply the Products, or pharmaceutical product
used in Optional Product according to the terms of this Agreement,
including the Product Specification;
(c)
the
cost of any recall of the Product or the Optional Product to the
extent that recall is due to DAEWOONG’s failure to
manufacture and supply according to the terms of this Agreement,
including the Product Specification;
(d)
any
fault, negligence or wilful misconduct of DAEWOONG, its Affiliates
or any of their respective officers, employees and agents with
respect to the performance of this Agreement except to the extent
that the Liability or Loss in question resulted from the gross
negligence act or wilful misconduct of STOCOSIL, or its
Affiliate(s) or any of its or their employees, agents or
subcontractors, or any breach by STOCOSIL of any of its
obligations, representations or warranties under this Agreement;
and
(e)
any
infringement of any third party’s Intellectual Property as a
result of any Manufacturing process used with respect to the
Product or pharmaceutical product used in an Optional Product
supplied to STOCOSIL under this Agreement to the extent that
DAEWOONG has failed to disclose to STOCOSIL in writing prior to the
date of this Agreement the specifics of such Manufacturing process
which is the subject of the infringement.
16.2
STOCOSIL
shall defend, indemnify and hold harmless DAEWOONG from and against
any and all Liabilities and Losses that may be, respectively,
brought by a third party against, suffered or incurred by DAEWOONG
and/or any of its Affiliate(s) and arising out of or in connection
with:
(a)
any
third party personal injury, illness or death, or loss or damage to
third party property arising from the use or sale by STOCOSIL of
the non-pharmaceutical part of the Optional Product;
(b)
any
fault, negligence or wilful misconduct of STOCOSIL, its
Affiliates or any of their respective officers, employees, agents
or subcontractors with respect to the performance of this Agreement
except to the extent that the Liability or Loss in question
resulted from the negligence or wilful misconduct of DAEWOONG, or
its Affiliate(s) or any of its or their employees, agents or
subcontractors, or any breach by DAEWOONG of any of its
obligations, representations or warranties under this
Agreement;
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(c)
a
breach of representation or warranty made by STOCOSIL under this
Agreement;
(d)
the
costs of any recall of the Optional Product to the extent that
recall is due to the non-pharmaceutical portion of the Optional
Product, TDM; and
(e)
Any
claim of infringement of any third party’s Intellectual
Property of the non-pharmaceutical portion of the Optional Product,
TDM outside of the Territory other than an infringement as a result
of any Manufacturing process usedwith respect to the pharmaceutical
product of Optional Product supplied to STOCOSIL under this
Agreement,
16.3 Notification
of Liabilities/Losses.
In
the event that either party intends to seek indemnification for any
claim under any of Section 16.1
or Section16.2,
it will inform the other party of the claim promptly after
receiving notice of the claim. that:
(a)
In
the case of a claim for which any STOCOSIL, indemnified party seeks
indemnification under Section 16.1,
STOCOSIL will permit DAEWOONG to direct and control the defense of
the claim and will provide such reasonable assistance as is
reasonably requested by DAEWOONG (at DAEWOONG’s cost) in the
defense of the claim; provided that nothing in this Section 16.3
will permit DAEWOONG to make any admission on behalf of STOCOSIL,
or to settle any claim or litigation which would impose any
financial obligations on STOCOSIL without the prior written consent
of STOCOSIL, such consent not to be unreasonably withheld or
delayed.
(b)
In
the case of a claim for which any DAEWOONG, indemnified party seeks
indemnification under Section 16.2,
DAEWOONG will permit STOCOSIL to direct and control the defense of
the claim and will provide such reasonable assistance as is
reasonably requested by STOCOSIL (at STOCOSIL’s cost) in the
defense of the claim, provided that nothing in this Section 16.3
will permit STOCOSIL to make any admission on behalf of DAEWOONG,
or to settle any claim or litigation which would impose any
financial obligations on DAEWOONG without the prior written consent
of DAEWOONG, such consent not to be unreasonably withheld or
delayed.
Limitations: Neither party limits or excludes its liability
for fraudulent misrepresentation nor for death or personal injury
arising from its negligence.
16.4 Limitation
of Liability
16.4.1
Except
for a breach of Clause 11.1 (confidentiality) or for any claims of
a third party which are subject to indemnification under this
clause 18, neither STOCOSIL nor DAEWOONG, nor any of their
respective affiliates or sublicensees will be liable to the other
party to this agreement, its affiliates or any of their
sublicensees for any indirect, incidental, consequential, special,
reliance, exemplary or punitive damages or lost or imputed profits
or royalties, lost data or cost of procurement of substitute goods
or services, whether liability is asserted in contract, tort
(including negligence and strict product liability), indemnity or
contribution, and irrespective of whether that party or any
representative of that party has been advised of, or otherwise
might have anticipated the possibility of, any such loss or
damage.
16.4.2
Neither
Party limits or excludes its liability for fraud, fraudulent
concealment or fraudulent misrepresentation, nor for death or
personal injury arising from its negligence.
16.5 Product
Liability without either Party’s Negligence and/or Fault
(“Inherent Risk”)
16.5.1
For
any Product related liability without either party’s
negligence and/or fault (“Inherent Risk” of the Product
and/or Optional Product) within the Territory, STOCOSIL shall be
responsible for Loss and damages directly related to the Inherent
Risk. As specified in Clause 20, STOCOSIL shall carry
proper and appropriate insurance coverage in the
Territory.
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16.5.2
For
any Product related liability without either party’s
negligence and/or fault (“Inherent Risk” of the Product
and/or Optional Product) outside of the Territory, DAEWOONG shall
be responsible for Loss and damages directly related to the
Inherent Risk. As specified in Clause 20, DAEWOONG shall
carry proper and appropriate insurance coverage outside of the
Territory.
17. TERMINATION
17.1
STOCOSIL
may terminate this Agreement with sixty (60) Business Days notice
in relation to the Product and/or Optional Product in a specific
country if STOCOSIL reasonably determines, using the same standards
it would use in assessing whether or not to continue Development,
Manufacture or Commercialization of a Product of its own making,
that the patient, medical/scientific, technical, Intellectual
Property, regulatory or commercial profile of the Product does not
justify continued Development, Manufacture or Commercialization of
that Product in or for such country. For the avoidance
of doubt, termination shall be on a country-by-country basis and
product-by-product basis.
17.2
Either
party may terminate this Agreement with sixty (60) days’
notice if the other Party commits a material breach (excluding
non-payment), unless the breach is cured within the sixty (60) day
notice period; provided, that with respect to non-payment breaches
the notice and cure period shall be reduced to thirty (30) days;
and provided further, that the sixty (60) day cure period may be
extended if the existence of a material breach is the subject of an
arbitration request (independent third
party/mediator).
17.3
Either
Party may terminate this Agreement if, at any time,
(a)
if
the other Party becomes insolvent or if proceedings are instituted
against the other Party for re-organization or other relief under
bankruptcy law, or if any substantial part of the other
Party’s assets come under the jurisdiction of a receiver or
trustee in an insolvency proceeding authorized by law;
(b)
by
either Party upon written notice if proceedings are instituted
against any of the Party for reorganization or other relief under
any bankruptcy law;
(c)
by
either Party in the event of a force majeure in accordance with
Clause 21.5 below.
18. CONSEQUENCES
OF TERMINATION
18.1
If
STOCOSIL terminates in accordance with Clause 17.1, 17.2
and/or 17.3, DAEWOONG shall, no later than ten (10)
Business Days after STOCOSIL’s request but at
DAEWOONG’s cost if there is default on the part of
DAEWOONG:
(a)
In
case of such termination DAEWOONG shall pay all non-cancellable
expenses reasonably incurred by STOCOSIL, including costs STOCOSIL
incurred in giving effect to such termination and costs of
terminating any commitments entered into under the
Agreement. Additionally, DAEWOONG will ensure the return
or delivery to STOCOSIL (or its nominee) or destruction by DAEWOONG
at STOCOSIL’s option of all copies of STOCOSIL’s
Confidential Information, STOCOSIL Background, IP,
STOCOSIL Arising IP, and STOCOSIL Know-How and Regulatory
Documentation and Regulatory Dossiers (together with all the
copies, abstracts or summaries thereof, any excess substances or
trial batches of the Product produced by DAEWOONG and any
quantities of Material, samples or consumables, including Materials
purchased in furtherance of DAEWOONG’s obligations under this
Agreement, remaining in DAEWOONG’s possession). DAEWOONG
agrees that this obligation is not conditioned upon
STOCOSIL’s prior payment of amounts due or agreement to pay
any amounts in dispute;
(b)
Discontinue
Development and Manufacture, of the Product; and
(c)
Deliver
to STOCOSIL or to such other parties as STOCOSIL may designate any
remaining deliverables (i.e. data, information, etc.)
that may then be in possession or custody of DAEWOONG or dispose of
them in such manner as STOCOSIL may specify;
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18.2
If
STOCOSIL terminates this Agreement in accordance with Clause 17.1,
17.2 and/or 17.3, all rights and licenses granted by STOCOSIL to
DAEWOONG hereunder shall immediately terminate and DAEWOONG shall
have no right to any continued use of the STOCOSIL Background IP,
STOCOSIL Arising IP, STOCOSIL’s Confidential Information and
STOCOSIL’s Know-How.
18.3
Notwithstanding
the above, should DAEWOONG exercise its Step-In Rights in
accordance with Clause 4.5 and/or Clause 6.3, STOCOSIL shall as
reasonably practicable transfer all data and information in
STOCOSIL’s control relating to a Product to (i) ensure that
any ongoing Development or Commercialization continues with minimal
disruption and to the extent any materials are not transferable,
STOCOSIL shall use Commercially Reasonable Efforts to make such
materials available to DAEWOONG and to practice any licence granted
under 2.2.2.
18.4
If
DAEWOONG terminates in accordance with Clause 17.2 or 17.3,
STOCOSIL shall, no later than ten (10) Business Days after
DAEWOONG’s request but at STOCOSIL’s cost if there is
default on the part of STOCOSIL:
(a)
Ensure
the return or delivery to DAEWOONG (or its nominee) or destruction
by STOCOSIL at DAEWOONG’s option of all copies of
DAEWOONG’s Confidential Information, and DAEWOONG Background
IP, and DAEWOONG Know-How (together with all the copies, abstracts
or summaries thereof, any excess substances or trial batches of the
Product produced by DAEWOONG and any quantities of Material,
samples or consumables, including Materials purchased in
furtherance of DAEWOONG’s obligations under this Agreement,
remaining in STOCOSIL’s possession). STOCOSIL agrees that
this obligation is not conditioned upon DAEWOONG’s prior
payment of amounts due or agreement to pay any amounts in
dispute;
18.5
In
case of such termination STOCOSIL shall pay all non-cancellable
expenses reasonably incurred by DAEWOONG, including costs DAEWOONG
incurred in giving effect to such termination and costs of
terminating any commitments entered into under the
Agreement. Such final sum shall not exceed the price
payable by STOCOSIL in accordance with the terminated service. If
upon the effective date of termination, STOCOSIL has advanced funds
which are unearned by DAEWOONG, DAEWOONG shall repay such funds to
STOCOSIL within thirty (30) days of the effective date of
termination.
18.6
Furthermore,
the Parties agree to provide each other with reasonable support
with respect to any investigation required by any Regulatory
Authority with respect to Development , Manufacture and
Commercialization of the Product carried out prior to such
termination and after such termination provided that the reasonable
costs of the assisting party in providing such assistance shall be
at the other Party’s cost.
18.7
Termination
shall not affect or prejudice any right to damages or other remedy
which either party may have in respect of the event giving rise to
the termination or any other right to damages or other remedy which
either party may have in respect of any breach of this Agreement
which existed at or before the date of termination.
19. AUDITING
Each
party will have the right, upon forty-five (45) days prior written
notice and during normal business hours, through an independent
third party representative (who will agree to be bound by
confidentiality provisions to review and inspect the other party's
books and records which relate to such other parties's operations
under this Agreement including, but not limited to, records
concerning Commercial Sales, Net Sales, Product Development Costs,
sales presentations, and other costs. An inspection shall not occur
more than once in any consecutive two calendar years. The party
whose records are being inspected may designate competitively
sensitive information which the representative may not disclose to
the other party, provided, however, that such designation shall not
encompass the representative's conclusions. Such representative
shall only report inaccuracies in amounts payable under this
Agreement. With respect to inspection of STOCOSIL’s or
designated Affiliate books and records, DAEWOONoong may request
that an independent auditor familiar with STOCOSIL record keeping
systems be present at the inspection to assist DAEWOONG auditor in
using STOCOSIL’s internal record management system. Likewise,
with respect to inspection of DAEWOONG books and records, STOCOSIL
may request that
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an
independent auditor familiar with DAEWOONG's record keeping systems
be present at the inspection to assist STOCOSIL auditor in using
DAEWOONG's internal record management system. Each party shall bear
the costs and expenses of its representative for inspections
conducted under this Section, unless a variation or error producing
an underpayment in amounts payable exceeding 5% of the amount paid
for any period covered by the inspection is established in the
course of any such inspection, whereupon all costs relating to the
inspection for such period and any unpaid or overpaid amounts that
are discovered will be paid or credited as appropriate by the party
in whose favor the deviation occurred. When a variation or error
producing an underpayment in amounts payable exceeding 5% of the
amount paid for any period covered by the inspection, such
underpayment will be treated as late payment and will be handled
according to the Clause 9.6.8. This Section will survive
the expiration or the termination of the Agreement for a period of
two (2) years.
20.1
Each
Party shall maintain at its own cost full and sufficient third
party, public and product liability, and product recall insurance,
to cover its actual and potential liabilities hereunder in the
respective Territory (STOCOSIL shall cover the Territory, and
DAEWOONG will cover the outside of the Territory) and shall provide
to the other a certificate of such insurance (or equivalent) upon
request.
20.2
Each
Party shall maintain the insurances referred to in Clause 20.1
above throughout the Term of this Agreement and thereafter for such
period as shall be equal to the longest shelf life of all or any of
the Products (provided always that such insurances will respond to
claims made at any time before the end of the period of five (5)
years after termination of this Agreement).
20.3
Further,
DAEWOONG will maintain a proper property & casualty insurance
for its manufacturing sites.
21. MISCELLANEOUS
21.1
Governing Law and Alternative Dispute
Resolution
21.1.1
This
Agreement and any non-contractual obligations arising out of or in
connection with it shall be governed by the law of
Singapore.
21.1.2
Any
dispute, claim, difference or controversy arising out of, relating
to or having any connection with this Agreement, including any
dispute as to its existence, validity, interpretation, performance,
breach or termination or the consequences of its nullity and any
dispute relating to any non-contractual obligations arising out of
or in connection with it (for the purpose of this Clause 21, a
Dispute), shall be referred
to and finally resolved by arbitration under International Chamber
of Commerce (ICC) (for the purpose of this clause, the Rules), which Rules are
incorporated by reference into this clause. The number of
arbitrators shall be three. The language of the
arbitration shall be English. The seat, or legal place
of arbitration, shall be Singapore. Nothing contained in
this Clause 21 shall limit the right of any party to seek from any
court of competent jurisdiction, pending appointment of an arbitral
tribunal, interim relief in aid of arbitration or to protect or
enforce its rights under this agreement.
21.2 Counterparts
and Electronic Signatures
21.2.1 This
Agreement may be executed and delivered in one or more
counterparts, and by the different Parties hereto in separate
counterparts each of which when executed shall be deemed an
original, but all of which taken together shall constitute one and
the same Agreement.
21.2.2 This
Agreement, to the extent signed and delivered by means of a
facsimile machine or electronic transmission (including a PDF
file), shall be treated in all manner and respects as an original
Agreement and shall be considered to have the same binding legal
effect as if it were the original signed version thereof delivered
in person. At the request of one Party, the other Party
to this Agreement shall re-execute original forms thereof and
deliver them to such first Party.
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21.3 Entire
Agreement
21.3.1 This
Agreement constitutes the entire Agreement and understanding of the
Parties and supersedes any prior Agreements or understandings
between the Parties with respect to the subject matter
hereof. No representation, undertaking or promise shall
be taken to have been given or be implied from anything said or
written in negotiations between the Parties prior to this
Agreement, except as expressly stated in this
Agreement.
21.4 Further
Assurances
21.4. Each
Party shall perform all further acts and things and execute and
deliver such further documents as may be necessary or as the other
Party may reasonable require to implement or giving effect to this
Agreement.
21.5 Force
Majeure
21.5.1 Neither
Party shall be liable for any delay in the performance of any of
the duties or obligations of that Party, provided that such delay
has been caused by or is the result of any act of God, fire,
explosion, flood, drought, war, disease, acts of terrorism, riot,
sabotage, embargo, general strikes, or compliance with any order or
regulation of any government entity acting with colour of right or
any other events of a similar nature and/or
magnitude. (“Event of Force
Majeure”). Events of Force Majeure exclude labour
disputes and strikes of solely the affected Party’s
personnel.
21.5.2 The
Party suffering the Event of Force Majeure shall within thirty (30)
days of the occurrence of the Event of Force Majeure give written
notice to the other Party stating the nature of the Event of Force
Majeure, its anticipated duration and any action being taken to
avoid or minimize its effect. Any suspension of
performance shall be of no greater scope and of no longer duration
than is reasonably required and the Party suffering the Event of
Force Majeure shall use Commercially Reasonable Efforts to remedy
its inability to perform including through the use of alternative
sources, workarounds and implementing a business continuity plan to
be agreed by the Parties; provided,
however,
if the suspension of performance continues for sixty (60) days
after the date of the occurrence, and such failure to perform would
constitute a material breach of this Agreement in the absence of
such Event of Force Majeure, the Parties shall meet and discuss in
good faith any amendments to this Agreement to permit the other
Party to exercise its rights under this Agreement.
21.5.3 Should
the Parties be unable to reach agreement within fifteen (15) days
of the commencement of good faith discussions in accordance with
clause 21.5.2 regarding any amendments to this Agreement to permit
the Party suffering the Event of Force Majeure to exercise its
rights under this Agreement, either Party may terminate this
Agreement by written notice to the other Party.
21.5.4 Neither
Party shall have the right to any additional payments from the
other Party as a result of any Event of Force Majeure.
21.6 Relationship
of the Parties
21.6.1 The
status of a Party under this Agreement shall be that of an
independent contractor. Nothing expressed or implied in
this Agreement shall be construed as creating a partnership, joint
venture or agency relationship between the Parties or, except as
otherwise expressly provided in this Agreement, as granting either
Party the authority to bind or contract any obligation in the name
of or on the account of the other Party pr to make any
statements, representations, warranties or commitments on behalf of
the other Party, except upon the prior written consent of the other
Party to do so. All persons employed by a Party shall be employees
of such Party and not of the other Party and all costs and
obligations incurred by reason of any such employment shall be the
account and expense of such Party.
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21.7 Third
Party Rights
The
Parties agree that this Agreement is not intended by either of the
Parties to create rights or benefits in favour of any Third Party
or make any rights or benefits enforceable by or on behalf of such
Third Parties and, for the avoidance of doubt and to the extent
permitted by law, any laws in any country in the Territory contrary
to provisions of this Clause are excluded.
21.8 Notices
21.8.1
Any
notice or other communication to be given under this agreement must
be in writing (which excludes fax, email and any other form of
electronic communication) and must be delivered or sent by post to
the party to whom it is to be given as follows:
(a)
to
DAEWOONG at:
000-0,
Xxxxxxx-Xxxx, Xxxxxxx-Xx, Xxxxx, Xxxxx
marked
for the attention of Jeon, SengHo
(b)
to
STOCOSIL at:
00000
Xxxxxx Xxx, Xxxxx 000, Xxxxxxxx Xxxxxx, XX 00000
marked
for the attention of Xxxxx Xxxxx
with
a copy to Legal Operations, Business Development at
00000
Xxxxxxxxx Xx, , Xxxxx 000, Xxxx Xx Xxxxxxxx, XX 00000xx at any such
other address of which it shall have given notice for this purpose
to the other party under this clause. Any notice or
other communication sent by post shall be sent by prepaid recorded
delivery post (if the country of destination is the same as the
country of origin) or by prepaid airmail (if the country of
destination is not the same as the country of origin).
21.8.2
Any
notice or other communication shall be deemed to have been
given:
(a) if
delivered, on the date of delivery; or
(b) if
sent by post, on the second Business Day after it was put into the
post.
21.8.3
In
proving the the giving of a notice or other communication, it shall
be sufficient to prove that delivery was made or that the envelope
containing the communication was properly addressed and posted by
prepaid recorded delivery post or by prepaid airmail or that the
fax was properly addressed and transmitted, as the case may
be.
21.8.4
This
Clause 21 shall not apply in relation to the service of any claim
form, notice, order, judgment or other document relating to or in
connection with any proceedings, suit or action arising out of or
in connection with this agreement.
21.9 Expenses
21.9.1 Each
of the Parties hereto shall be responsible for the payment of its
own costs and expenses incurred in connection with the negotiations
leading up to and the performance of its own obligations pursuant
to this Agreement and the Transaction Documents, including the fees
of any legal advisors, accountants, brokers or advisors employed or
retained by or on behalf of such Party. Notwithstanding
the foregoing, if this Agreement is terminated, this Clause 21.9
shall not affect any rights that either Party may have arising from
any breach hereof.
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21.10 Waivers
and Modifications
21.10.1 The
failure of any Party to insist on the performance of any obligation
hereunder shall not be deemed to be a waiver of such obligation,
right or remedy or prevent such Party from enforcing any or all
provisions of this Agreement and exercising any rights or
remedies.
21.10.2 The
rights and remedies provided in this Agreement and all other rights
and remedies available to either Party at law or in equity are, to
the extent permitted by law, cumulative and not exclusive of any
other right or remedy now or hereafter available at law or in
equity. Neither asserting a right nor employing a remedy
shall preclude the concurrent assertion of any other right or
employment of any other remedy, nor shall the failure to assert any
right or remedy constitute a waiver of that right or
remedy.
21.11 Prior
Agreements – Amendments
21.11.1 No
waiver, modification, release or amendment of this Agreement shall
be valid or binding upon the Parties, unless in writing and signed
by authorised representatives of both Parties.
21.12 Severability
21.12.1 The
provisions of this Agreement are severable, and the
unenforceability of any provision of this Agreement shall not
affect the enforceability of the remainder of this
Agreement. The Parties acknowledge that it is their
intention that if any provision of this Agreement is determined by
a court to be unenforceable as drafted, that provision should be
construed in a manner designed to effectuate the purpose of that
provision to the greatest extent possible under applicable
law.
21.13 Language
21.13.1 The
language of this agreement and the transactions envisaged by it is
English and all notices to be given in connection with this
agreement must be in English. All demands, requests,
statements, certificates or other documents or communications to be
provided in connection with this agreement and the transactions
envisaged by it must be in English or accompanied by a certified
English translation; in this case the English translation prevails
unless the document or communication is a statutory or other
official document or communication
21.14 Export
Control
21.14.1 This
Agreement is made subject to any restrictions concerning the
exports or technical information from the United States or other
countries that may be imposed on the Parties from time to
time. Each Party agrees that it will not export,
directly or indirectly, any technical information acquired from the
other Party under this Agreement or any products using such
technical information to a location or in a manner that at the time
of export requires an export license or other governmental
approval, without first obtaining the written consent to do so from
the appropriate agency or other Regulatory Authority in accordance
with Applicable Law.
[THE REMAINDER OF THIS PAGE
INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF the parties have caused this Agreement to
be executed on their behalf by their duly authorized
representatives as of the Execution Date.
|
STOCOSIL, Inc.
_____________________________________
Signed
Name:
Position
Date:
AUTOTELIC, LLC
|
DAEWOONG Pharmaceuticals Co. Ltd
_____________________________________
Signed
Name:
Xxxxxxxx Xxx
Position:
CEO, President
Date:
|
_____________________________________
Signed
Name:
Position
Date:
AUTOTELIC, Inc.
_____________________________________
Signed
Name:
Position
Date:
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SCHEDULE 1
KEY TERMS OF THE MANUFACTURING AND SUPPLY AGREEMENT
(“MSA”)
|
(1)Parties
|
(i)DAEWOONG
(or an appropriate Affiliate)
(ii)STOCOSIL
(or an appropriate Affiliate)
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(2)Scope
|
Terms
and conditions applicable to the Manufacture and supply by DAEWOONG
to STOCOSIL of the Product for:
(i)Commercialization
by STOCOSIL as Product or pharmaceutical product of the Optional
Product in any country in the Territory
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(3)Exclusivity
and exceptions
|
(i)Subject
to (3)(ii) below, STOCOSIL shall purchase all the Product for
Commercialization in the Territory from DAEWOONG.
(ii)STOCOSIL
shall no longer be required to purchase all of its requirements of
Product from DAEWOONG and shall be entitled to Manufacture (or have
Manufactured by a Third Party) the Product if, even though both
Parties diligently pursue in good faith the remedy, :
(a)DAEWOONG
is unable to Manufacture and supply sufficient quantities of the
Product to satisfy STOCOSIL’s demand for that Product;
or
(iii)DAEWOONG
fails to remediate any quality issues identified by STOCOSIL,in
accordance with Product Specifications, in respect
of the manufacturing site(s) or the Products. In the
event that STOCOSIL does Manufacture (or have Manufactured by a
Third Party) any Product in accordance with the terms of the MSA,
DAEWOONG shall provide (at its own cost, subject to (3)(v) below,
and at STOCOSIL’s request):
(a)reasonable
assistance to STOCOSIL in sourcing high quality API and all other
Materials at a competitive price;
such
technical transfer assistance (including the granting a fully-paid
up, perpetual, royalty-free license, if required, on a
non-exclusive basis,and disclosure of all relevant IP and Know-How
under suitable conditions of confidentiality) as STOCOSIL or its
Third Party contract manufacturer may reasonably require to enable
them to manufacture the Product.
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(3)Exclusivity
and exceptions (continued)
|
(iv)In
the event that (3)(ii)(b) applies, the Parties shall discuss in
good faith the extent (if any) to which DAEWOONG may continue to
supply the affected Product taking into account all relevant
circumstances (including the economic consequences to STOCOSIL of
sourcing from a Third Party only the surplus volumes that DAEWOONG
is unable to supply rather than sourcing all of its requirements
for the affected Product from that Third Party), whether or not any
such continued supply shall be under the MSA or another agreement
and any appropriate amendments that may be required to be made to
the MSA.
(v)In
relation to any technical transfer assistance provided by DAEWOONG
pursuant to (3)(iii) above, STOCOSIL (or its Third Party contract
manufacturer) shall be responsible for the costs of the API,
excipients and tooling required to Manufacture the relevant Product
(including any such API and excipients required to Manufacture
validation batches of such Product). Without limiting
the generality of (3)(iii) above, DAEWOONG shall be responsible for
all costs and expenses related to the involvement of its employees
or consultants in the technical transfer process (including any
travel and accommodation expenses incurred by such employees or
consultants).
(vi)If
STOCOSIL wishes to use an alternative source of supply for the
Product in circumstances contemplated by (3)(ii) above, STOCOSIL
shall be entitled to use DAEWOONG’s Regulatory Dossier in
support of any regulatory submission that STOCOSIL may be required
to make in relation thereto.
(vii)STOCOSIL
may continue to order Product from DAEWOONG, and DAEWOONG shall
continue to supply STOCOSIL with Product pursuant to the
MSA until such time as STOCOSIL notifies DAEWOONG in writing that
alternative source has been validated and all necessary Regulatory
Approvals are in place to allow STOCOSIL (or its nominated Third
Party manufacturer) to Manufacture the relevant
Product.
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(4)Sourcing
and storage of Materials
|
(i)DAEWOONG
shall be responsible for sourcing all API and other Materials
required for the Manufacture of Products under the
MSA. STOCOSIL (and not DAEWOONG) shall be responsible
for sourcing API and Materials for the Manufacture of any Products
by or on behalf of STOCOSIL pursuant to (3)(ii) above.
(ii)In
the event that STOCOSIL supplies API or other Materials to DAEWOONG
(or its permitted Third Party sub-contractor) for use in the
Manufacture of Products on a tolling basis:
(a)those API and/or Materials shall be deemed to have zero
cost to DAEWOONG for the purposes of calculating the Supply Price
payable by STOCOSIL; but
(b)for the purposes of (3)(ii)(a) and (3)(ii)(b) above, the
Supply Price shall be deemed to be the sum of (a) the Supply Price
payable by STOCOSIL and (b) the costs and expenses incurred by
STOCOSIL in sourcing the relevant API and/or Materials and in
providing such API and/or Materials to DAEWOONG on a tolling
basis.
(iii)The
Party that is not responsible for sourcing the API and other
Materials shall provide reasonable assistance to the other Party in
sourcing high quality API and other Materials at a competitive
price.
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(5)Inspection
and analysis of Materials
|
(i)DAEWOONG
shall upon receipt of all Raw Materials or API (defined here as
Materials), conduct such inspections and analysis of API and other
Materials as may be specified in the Quality Agreement or required
by cGMP, any Manufacturing Licence, any relevant Marketing
Authorisation and/or Applicable Law.
(ii)DAEWOONG
shall conduct the required inspection and analysis irrespective of
whether the API or other Materials are sourced by DAEWOONG or by
STOCOSIL.
(iii)In
the event that any delivery of Materials is defective, DAEWOONG
shall reject that delivery and promptly notify STOCOSIL (and, if
DAEWOONG is responsible for sourcing the relevant Materials, the
relevant supplier). The Party responsible for sourcing
the relevant Materials shall procure that the supplier promptly
provides additional Materials in substitution for the defective
Materials.
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(6)Manufacture
|
(i)Subject
to (6)(ii), DAEWOONG shall Manufacture the Product in accordance
with cGMP, the Quality Agreement, the Manufacturing Licence, the
relevant Marketing Authorisation, the applicable specifications for
that Product and Applicable Law (including the Applicable Law of
the country in which the Product is to be Commercialized by
STOCOSIL).
(ii)DAEWOONG
will perform primary, secondary packaging or leafleting in relation
to the Product in accordance with the Marketing Authorisation
.. All such steps in the relation to the Product to be
Commercialized by STOCOSIL shall be performed by (or on behalf of)
DAEWOONG and shall be at DAEWOONG’s responsibility and
costs. Such costs will be part of COGS by
DAEWOONG.
(iii)DAEWOONG
shall Manufacture (or have Manufactured) the Product only at its
own manufacturing sites.
(iv)DAEWOONG
shall (at its cost) obtain and maintain all Manufacturing Licences
required to allow it to Manufacture Products in accordance with the
MSA.
(v)The
MSA will specify the agreed lead time, minimum order quantity
(“MOQ”) and incremental order quantity
(“IOQ”) for each Product. MOQ shall be one batch
size. Where a Product is subsequently added to the scope
of the MSA, the Parties shall agree such amendments to the MSA as
may be necessary to document the lead time, MOQ and IOQ applicable
to the Product.
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(7)Forecasts
and orders
|
(i)To
be furnished in Schedule 2. DAEWOONG shall deliver
Product pursuant to STOCOSIL’s written purchase orders
(“Firm Orer”) which have been confirmed in writing by
DAEWOONG
(ii)DAEWOONG
shall confirm each Firm Order within five (5) business days,
confirming the date for Delivery and quantities of
Products. If any discussion is required in respect of a
Firm Order, the Parties will seek to agree any necessary amendments
within two (2) business days of DAEWOONG’s response to the
Firm Order.
(iii)STOCOSIL
shall submit a Purchase Order reflecting each confirmed Firm Order.
Firm Orders shall be received by DAEWOONG at least 90 days before
the requested date of delivery.
(iv)Each
Firm Order for Product shall (unless otherwise agreed between the
Parties) be for a quantity that is equal to either (a) the MOQ for
that Product or (b) that MOQ together with a multiple of the IOQ
for that Product.
(v)Without
prejudice to (3)(ii)(d), DAEWOONG shall use its reasonable
endeavours to ensure that it has at all times sufficient
Manufacturing capacity at each Manufacturing Site to satisfy the
Products requirements set out in the Forecast
Schedule.
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(8)Samples
and stability studies
|
(i)DAEWOONG
shall retain samples of each batch of Materials and each batch of
Product in accordance with the Quality Agreement and
cGMP.
(ii)DAEWOONG
shall be responsible for performing (at its own cost) such
stability testing on the Product supplied to STOCOSIL pursuant to
the MSA as may be required by the Quality Agreement, any relevant
Marketing Authorisation, cGMP or as reasonably required by
STOCOSIL. If DAEWOONG wishes to outsource the
performance of stability testing to a Third Party, STOCOSIL must
first approve the use of such Third Party (such approval not to be
unreasonably withheld). In addition, the Parties shall
discuss whether such work can be performed more effectively and
efficiently by STOCOSIL or any Third Party performing primary or
secondary packaging for STOCOSIL in relation to the
Products. If the Parties agree that DAEWOONG shall
outsource stability testing to a Third Party, DAEWOONG shall remain
primarily liable to STOCOSIL for the performance of such work and
shall remain responsible for the costs of that
work. Such costs will be part of DAEWOONG’s
COGS.
|
|
(9)Storage
and Delivery of Products
|
(i)DAEWOONG
shall store Materials (and, pending Delivery. Products) in
accordance with cGMP and the Quality Agreement.
(ii)Product
shall be delivered on FOB Incheon Airport.
(iii)Each
Delivery of the Product shall be accompanied by a corresponding
Certificate of Analysis and any other documentation specified in
the Quality Agreement.
|
|
(10)Shelf
life
|
Unless
otherwise agreed between the Parties, each Product Manufactured by
(or on behalf of) DAEWOONG pursuant to the MSA shall upon
Delivery:
(i)if
the registered shelf life of such product is more than two (2)
years, have at least eithty per cent. (80%) of that registered
shelf life remaining; and
(ii)if
the registered shelf life of such product is two (2) years or less,
have at least eighty five per cent. (85%) of that registered shelf
life remaining.
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|
(11)Inspection
and analysis of Products
|
(i)STOCOSIL
shall upon receipt conduct such inspections and analysis of Product
as may be specified in the Quality Agreement to determine whether
the Product complies with the relevant specification.
(ii)If
STOCOSIL considers that any of the Product is defective, it will
notify DAEWOONG and the Parties will endeavour to agree whether or
not that Product is defective. Any payment obligations
in respect of the allegedly defective Product will be suspended
pending the resolution of this issue.
(iii)At
STOCOSIL’s request, DAEWOONG will Manufacture and supply a
replacement batch of Product as soon as practicable following
notification of the alleged defect.
(iv)If
the Parties are unable to agree whether Product is defective, the
matter will be referred to an independent third party laboratory to
determine whether the Product is conforming (acting as
an expert, not as an arbitrator). Except in the case of
fraud or manifest error on the part of such independent expert,the
decision of such independent expert will be binding upon the
Parties. If the independent expert decides that the
Product was not defective, the cost of the independent expert will
be borne by STOCOSIL. In all other circumstances, the
costs of the independent expert will be borne by
DAEWOONG.
(v)If
Product is agreed (or found) to be defective, DAEWOONG shall
dispose of that Product at its own cost and (if no replacement
batch has already been provided as contemplated by (11)(iii) above)
promptly Manufacture and supply replacement Product as soon as
possible but in any event no later than 30 days.
(vi)If
Product is agreed (or found) not to be defective, STOCOSIL shall
pay for that Product in accordance with the MSA.
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|
(12)Price
|
(i)Subject to (12)(ii) below, the Supply Price charged by
DAEWOONG for the Manufacture and supply of the Product for the
Development shall be DAEWOONG’s actual cost of Manufacture
(actual COGS of DAEWOONG, which is defined in the PRODUCT
DEVELOPMENT, LICENCE AND COMMERCIALIZATION AGREEMENT. Subject to
(12)(ii) below, the Supply Price charged by DAEWOONG for the
Manufacture and supply of the Product for the Commercial Sales in
the Territory shall be DAEWOONG’s actual cost of Manufacture
(actual COGS of DAEWOONG, which is defined in the PRODUCT
DEVELOPMENT, LICENCE AND COMMERCIALIZATION AGREEMENT plus 50%. For
the avoidance of doubt, the Manufacture of a Product shall include
stability testing unless the Parties agree that STOCOSIL shall
perform (or have performed) such stability tests as contemplated in
(8)(ii) above.
(ii)The
Supply Price applicable for the Product shall be reviewed by both
Parties during the 1st
Calendar Quarter of every Calendar Year. Both Parties reveiw the
market price of each API for the Product and calculate the average
price of 3 suppliers registered in the US-DMF for each API. That
average price shall become effective on the last day of the
1st
Calendar Quarter of every Calendar Year and shall be applied to
calculate a new COGS after such date.
(iii)Notwithstanding
(12)(ii) above, DAEWOONG shall keep STOCOSIL promptly informed of
any variation in the actual Supply Price (including reductions
achieved by means of the Continuous Improvement programme and
fluctuations caused by variations in the cost of Materials, labour,
overheads or other inputs to the Manufacturing
process).
|
-51-
|
(13)Title
and risk
|
(i)Title
to and risk in Product shall pass to STOCOSIL upon Delivery on FOB
Incheon Airport.
(ii)To
the extent any Materials are supplied to DAEWOONG by STOCOSIL,
DAEWOONG shall store such Materials in accordance with instruction
for such Materials at no cost to STOCOSIL, DAEWOONG shall only use
the Materials to manufacture Product for STOCOSIL, title
to those Materials shall remain with STOCOSIL at all times, but
DAEWOONG shall bear all risk of loss in those Materials
for so long as those Materials (or Products containing those
Materials) are in DAEWOONG’s possession or
control. DAEWOONG will maintain insurance to provide
appropriate coverage of Materials against theft or
damage.
|
|
(14)Continuous
Improvement
|
The
MSA shall include provisions dealing with the establishment and
implementation of a continuous improvement programme intended to
reduce the costs of Manufacture and/or improve the efficiency,
environmental impact and quality of the Manufacturing
process. The MSA shall include provisions allocating
between the Parties the benefit of any costs savings achieved by
means of this continuous improvement programme and determining the
ownership of any IP or Know-How created or reduced to practice in
the course of that programme.
|
|
(15)Marketing
Authorizations
|
STOCOSIL
shall be responsible for obtaining and maintaining any Marketing
Authorization required to allow it to Commercialize Product
supplied pursuant to the MSA. DAEWOONG shall provide
STOCOSIL with such reasonable assistance as it may require in
connection with obtaining or maintaining such Marketing
Authorizations.
|
|
(16)Premises
and insurance
|
DAEWOONG
shall maintain appropriate insurance for its manufacturing
site(s).
|
|
(17)Know-How,
IP and Technical Assistance
|
(i)STOCOSIL
shall grant DAEWOONG such licences of its IP and Know-How as
DAEWOONG may require to Manufacture the Product.
(ii)DAEWOONG
shall grant STOCOSIL such licences of its IP and Know-How as
STOCOSIL may require to Commercialize the Product in the
Territory.
|
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|
(18)Regulatory,
compliance and environmental
|
(i)DAEWOONG
shall co-operate with Regulatory Authorities and provide any
information and documentation that a Regulatory Authority may
require. STOCOSIL will be the primary interface with all
regulatory authorities in the Territory and DAEWOONG will
immediately inform STOCOSIL if it is contacted by a regulatory
authority within the Territory with regard to any
submission to a Regulatory Authority and in relation to any
anticipated inspection by a Regulatory Authority of a manufacturing
site.
(ii)In
the event of any inspection by regulatory authorities inside the
Territory (including cGMP inspections), STOCOSIL will provide
reasonable assistance to DAEWOONG in preparing for such
inspections. Notwithstanding this, DAEWOONG shall be
responsible for ensuring that its Manufacturing Sites meet all
applicable cGMP standards, Production Standards, and the
requirements of the MSA (including the Quality
Agreement).
(iii)DAEWOONG
shall be responsible for preparing and submitting the Regulatory
Dossiers to STOCOSIL for the Product as a CMO for inclusion into
any Product Registration of STOCOSIL. DAEWOONG shall
provide all submissions to regulatory authorities
including (whether or not submitted) CTD files, data and
documentation from clinical studies and CMC documentation, relating
to the Product, as well as all correspondence with regulatory
authorities (such as registration and licenses, regulatory drug
lists, regulatory dossier, advertising and promotion documents),
adverse event files, complaint files, manufacturing records and
inspection reports as well as all relating intellectual property
rights protecting the same and any invention embodied in such
documentation ("Regulatory Documentation") to STOCOSIL for its use
for seeking Product Registration of the the Product in any country
in the Territory. DAEWOONG hereby grants a perpetual, irrevocable,
fully paid up right on a non-exclusive basis to reference to any
data contained in all Regulatory Documentation, Product
Registrations, post marketing studies, regulatory dossiers and any
other data with respect to the Product, for use in STOCOSIL's
Product Registration in any country in the Territory.
(iv)DAEWOONG
shall be responsible for all waste disposal, and all costs related
thereto, connected with the Manufacture of the Product
and for compliance with Applicable Law in relation to such
disposal.
|
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|
(19)Quality
assurance and pharmacovilgilane
|
(i)The
Parties agree to enter into a quality agreement within 90 days of
the Effective Date which sets forth (a) the roles and
responsibilities of the Parties with respect to cGMP and other
quality regulations for the Product as required under Applicable
Laws, and (b) how the Parties shall interact with each other in
connection with the same (the "Quality Agreement"). In
the event a conflict arises between any term in this Agreement and
a term in the Quality Agreement, the term contained in this
Agreement shall prevail.
(ii)The
Parties agree to enter into a global pharmacovilgilance agreement,
within 120 days of the Effective Date, which sets forth the global
safety data exchange procedures to be followed by th Parties for
the collection, investigation, reporting, and exchange of
information concerning adverse events.
(iii)DAEWOONG
shall comply with the Quality Agreement and shall institute and
maintain appropriate process controls for the Manufacture of the
Product and shall maintain suitable records of such controls which
shall be made available to STOCOSIL on request.
(iv)DAEWOONG
shall (at STOCOSIL’s request and cost) supply such samples of
the Product or Materials as STOCOSIL may reasonably
require.
(v)DAEWOONG
shall promptly report any adverse trends that arise during the
normal or stability testing of any of the Product, provided that
DAEWOONG shall not be responsible for doing so if STOCOSIL or
STOCOSIL’s Third Party contract manufacturer undertake
responsibility for stability testing as contemplated in
8(ii).
(vi)DAEWOONG
shall appoint a Senior Quality Manager who shall be responsible for
signing each Batch Record and Certificate of Analysis and for the
release of the Product.
|
|
(20)Access
to premises and audits
|
(i)STOCOSIL
shall be permitted to enter DAEWOONG’s manufacturing site(s)
to conduct technical, cGMP and/or environmental inspections
and audits on an annual basis (or more frequently for
cause).
(ii)DAEWOONG
shall ensure that any permitted sub-contractor also
allows STOCOSIL to conduct such audits and inspections of any
manufacturing site operated by such sub-contractor.
|
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|
(21)Customer
complaints and recalls
|
(i)DAEWOONG
will maintain complete and accurate records with respect to the
Products, including without limitation, the manufacturing and
adequate despatch and analytical records to allow quality and
destination of Products to be assessed in the event of a
complaint. STOCOSIL will be permitted to access these
records as necessary.
(ii)DAEWOONG
will notify STOCOSIL of any quality issue or complaint it becomes
aware of and will investigate any such issue at STOCOSIL’s
request but at DAEWOONG’s own cost.
(iii)STOCOSIL
will have control over any recall of Product and will devise the
recall strategy in the Territory. DAEWOONG will assist
in that strategy as needed. STOCOSIL shall (if lawful
and practical to do so) give DAEWOONG prior written notice of any
recall that STOCOSIL proposes to make of the Product outside of the
Territory. The
final decision of any recall of Product outside of the Territory
will be DAEWOONG’s.
(iv)The
costs of a Product recall will be borne by DAEWOONG if it results
from DAEWOONG’s failure to comply with the MSA or
DAEWOONG’s negligence. Otherwise, STOCOSIL will be
bear the costs of recall.
|
|
(22)Warranties
and indemnities
|
(i)DAEWOONG
will warrant (a) compliance as regards Products, processes and
waste disposal with Specifications, Quality Agreement,
Manufacturing Licence, Marketing Authorisations, GMP and Applicable
Laws (including environmental laws), (b) conveyance of good title
to Products, (c) that it holds all necessary consents and licences,
(d) that there is no active or pending litigation or investigation
involving DAEWOONG.
(ii)DAEWOONG
will indemnify STOCOSIL against loss and damage caused by (a)
breach of DAEWOONG’s warranties, (b) third party death or
personal injury arising from a failure to Manufacture a Product in
accordance with the MSA, (c) gross negligence or wilful misconduct
by DAEWOONG or its employees and (d) costs of Product recalls that
DAEWOONG is responsible for under (21) above, in each case unless
caused by the gross negligence or wilful misconduct of STOCOSIL or
its employees.
(iii)STOCOSIL
will indemnify DAEWOONG against loss and damage caused by (a) third
party death or personal injury arising from a Product that was
fully compliant with the MSA upon delivery, (b) gross negligence or
wilful misconduct by STOCOSIL or its employees and (c) costs of
Product recalls that STOCOSIL is responsible for under (21) above,
in each case unless caused by the gross negligence or wilful
misconduct of DAEWOONG or its employees.
|
|
(23)Ethical
standards and human rights
|
The
MSA will contain warranties and undertakings in the standard form
required by STOCOSIL of all suppliers in relation to ethical
standards, human rights and anti-bribery and corruption
procedures.
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|
(24)Documentation
and reports
|
(i)DAEWOONG
shall prepare and retain complete and systematic documentation
relating to the Manufacture of Products (including Batch Records,
Certificates of Analysis, quality records and any reports that the
Parties agree DAEWOONG should prepare).
(ii)DAEWOONG
will retain such documentation in accordance to applicable law
(which shall not be less than three (3) years) and shall allow
STOCOSIL to view and copy such records on reasonable notice during
the term of this MSA and three (3) years after
termination.
|
|
(25)Labelling
and Artwork
|
To
the extent relevant, DAEWOONG shall Manufacture each Product using
such labelling and artwork as STOCOSIL may specify. The
MSA shall include change control provisions covering any proposed
alteration of the labelling and artwork required to be affixed to
(or embossed on) any of the Product.
|
|
(26)Term
|
The
term of the MSA shall be the same as the PRODUCT DEVELOPMENT,
LICENCE AND COMMERCIALIZATION AGREEMENT.
|
|
(27)Expiry
and termination
|
(i)The
MSA shall expire at the end of the term unless renewed or
terminated earlier in accordance with the MSA.
(ii)The
MSA shall contain provision for STOCOSIL to terminate if (a)
STOCOSIL ceases to Commercialize the Products, (b) STOCOSIL elects
to move Manufacture of Products to a third party where permitted to
do so, (c) DAEWOONG is in uncured material or persistent breach of
the MSA, (d) DAEWOONG becomes insolvent, (e) DAEWOONG undergoes a
change of control or (f) new or unknown impurities are found in
Products. Termination for reasons (a), (b) and (f) shall
occur on a Product-by-Product basis. Termination for
reasons (c), (d) and (e) shall affect the MSA as a
whole.
(iii)The
MSA shall contain provision for DAEWOONG to terminate if the MSA as
a whole if (a) STOCOSIL is in uncured material or persistent breach
of the MSA, (b) STOCOSIL becomes insolventSTOCOSIL.
|
|
(28)Consequences
of expiry or termination
|
(i)Certain
provisions – e.g. those relating to retention of samples and
documentation for a specified number of years, confidentiality and
providing assistance in the event of a regulatory investigation
– will survive expiry or termination.
(ii)DAEWOONG
shall provide technical transfer assistance (and licences of
Know-How and IP) as contemplated in (3)(iii) above to permit
STOCOSIL, its Affiliates or its nominated Third Parties to
Manufacture Products.
(iii)Accrued
rights and obligations will survive termination.
|
|
(29)Confidentiality
|
The
MSA shall include customary provisions protecting the
confidentiality of any confidential information (including
Know-How) that may be disclosed by one Party to the other
Party. The provisions shall include customary
restrictions on the use and disclosure by a Party of the other
Party’s confidential information, subject to the usual
exceptions and DAEWOONG’s obligations to license Know-How in
circumstances contemplated by (3)(iii) and (29).
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|
(30)Assignment
and sub-contracting
|
(i)STOCOSIL
shall be permitted to assign or otherwise transfer, or to
sub-contract, any of its rights and obligations to any Affiliate or
a successor in title to the business in relation to one or more of
the Products and DAEWOONG shall enter into a novation agreement
upon request to give effect to any such transfer.
(ii)Save
as permitted by (31)(i), STOCOSIL shall not be permitted to assign
or otherwise transfer any of its rights or obligations under the
MSA without DAEWOONG’s prior written consent (not to be
unreasonably withheld).
(iii)DAEWOONG
shall not be permitted to assign or otherwise transfer any of its
rights or obligations under the MSA without STOCOSIL’s prior
written consent (not to be unreasonably withheld by
STOCOSIL).
(iv)DAEWOONG
shall not be permitted to sub-contract the performance of any of
its obligations under the MSA (including the Manufacture of any
Product) without STOCOSIL’s prior written consent (not to be
unreasonably withheld).
|
|
(31)Force
Majeure
|
The
MSA shall contain customary provisions excusing non-performance by
a Party of its obligations to the extent caused by force
majeure. The MSA shall also permit a Party to terminate
the MSA if the other Party is prevented by force majeure from
performing its obligations for an extended period.
|
|
(32)Governing
Law
|
Law
of Singapore.
|
|
(33)Jurisdiction
|
(i)Subject
to (34)(ii) and (34)(iii), the Singaperean courts shall have
exclusive jurisdiction.
(ii)Subject
to (34)(iii), if any dispute arising under the MSA is connected
with a dispute arising under the PDLCA, the dispute under the MSA
shall be referred to arbitration in accordance with the dispute
resolution provisions of the PDLCA.
(iii)Disputes
covered by (11) above shall be determined as provided in (11)
above.
|
|
(34)Other
customary terms
|
The
MSA will include customary terms regarding such matters as (i)
waiver, (ii) notices, (iii) entire agreement, (iv) relationship of
the Parties, (v) severability, (vi) amendment, (vii) counterparts
and (viii) any other relevant matters not covered in this term
sheet.
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|
(35)Schedules
|
The
MSA will have scheduled to it:
(i)a
Quality Agreement signed by DAEWOONG (or an appropriate Affiliate)
and STOCOSIL (or an appropriate Affiliate);
(ii)the
Specification(s) for each Product;
(iii)details
of the lead time, MOQ and IOQ for each Product;
(iv)records
retention requirements (to the extent not covered by the Quality
Agreement);
(v)key
performance indicators (if applicable and agreed);
(vi)EHS
guidelines; and
(vii)STOCOSIL’s
ABAC requirements.
|
|
(36)Adjustments
|
The
Parties acknowledge that certain terms of the MSA contemplated
above may need to be adjusted to reflect the nature or
characteristics of the Product. If either Party
reasonably considers that, in respect of the Product, the terms of
the MSA require such adjustment, the Parties shall discuss the
matter in good faith (each acting reasonably).
|
-58-
Product Price, Sales Forecast and Minimum Annual
Purchases
STOCOSIL Sales Forecast (for US and
Japan) – For Resistant Hypertension
(Unit:
package of 30T/box)
|
Year
1
|
Year
2
|
Year
3
|
Year
4
|
Year
5
|
Year
6
|
Year
7
|
Year
8
|
Year
9
|
Year
10
|
|
0.5
M
|
1.0
M
|
2.5
M
|
3.35
M
|
4.35
M
|
4.35
M
|
4.35
M
|
4.35
M
|
4.35
M
|
4.35
M
|
*
Basis for calculation :
1. Based on market research given by partner,
Prevalence
of hypertenion : 1.38B patients worldwidely
6%
hypertensive population in US and Japan (assumption)
22%
are uncontrolled or resistant HTN
50%
are simultaneously hypercholesterolemic and resistant
HTN
4%
penetration
it
gives 1.38B * 0.06 * 0.22 * 0.5 * 0.04 = 0.35M targeting population
in US and Japan
2.
0.35M
people * 12months/year * 1pckg/month = 4.35M pckg/year
3.
Regard
the result from ② as a
peak sales in Year 5.
Sales
forecast is to be readjusted upon completion of year 1 to reflect
actual market condition. Apply to only resistant HTN
only. Year 1 = 1 year after approval for resistant
HTN.
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