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Exhibit 10.2
Confidential Materials
omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
License and Development
Agreement
By and between
Arrow International
Limited
57 St. Christopher Street
Valletta, VLT 08, Malta
and
Sepracor Inc.
84 Waterford Drive
Marlborough, MA 01752
USA
This
License and Development Agreement (this "Agreement"), dated as of
April 30, 2008 is being entered into by and between Arrow
International Limited, a Malta corporation having its principal
office at 57 St. Christopher Street, Valletta, VLT 08, Malta,
and its Affiliates (collectively referred to as "Arrow"), and
Sepracor Inc., a corporation organized and existing under the
laws of the State of Delaware and having its principal office at 84
Waterford Drive, Marlborough, MA 01752, USA ("Sepracor"). Each or
both of Arrow and Sepracor are hereinafter referred to as "Party"
or "Parties", as intended in the given context.
RECITALS
A.
Sepracor wishes to
commercialize an inhalation pharmaceutical product containing a
combination of both levalbuterol and ipratropium as the sole active
ingredients.
B.
Arrow controls
certain Arrow Know-How and Arrow Patents relating to the
Product.
C.
Arrow has material
capabilities, resources and experience in the development and
analytical testing of inhalation pharmaceutical products, and has
made substantial progress in development of the Product.
D.
Sepracor has
material capabilities, resources and experience in the development,
clinical testing, regulatory approvals, commercialization,
marketing and distribution of branded inhalation pharmaceutical
products, including with respect to inhalation products containing
levalbuterol.
E.
Arrow wishes to
grant Sepracor an exclusive right and license under the Arrow
Technology to Develop, distribute and Commercialize the
Product.
F.
Sepracor wishes to work
collaboratively with Arrow to continue to Develop the Product and
subsequently to Commercialize the Product.
NOW,
THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the sufficiency of which is
hereby acknowledged, and intending to be legally bound, the Parties
to this Agreement mutually agree as follows:
Article 1 Definitions
For
the purposes of this Agreement, the following terms, whether used
in the singular or plural, shall be ascribed the following
meaning:
1.1
"Additional Product" means any product or proposed product,
other than the Product, which contains, [**].
1.2
"Affiliate" of either Party means any corporation, firm,
partnership, organization or entity, whether de jure or de facto,
which such Party directly or indirectly controls, is controlled by
or is under common control with. For the purpose of this
definition, the term "control" means (i) direct or indirect
ownership of fifty percent (50%) or more of the outstanding equity
voting stock (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular
jurisdiction) of a Party or other entity or (ii) the
possession, direct or indirect, of the power to direct or cause the
direction of the management and policies of a Party or other
entity, whether through the ownership of voting securities, by
contract, or otherwise.
1.3
"Arrow Know-How" means the Know-How Controlled by Arrow (for
purposes of clarity, including Affiliates of Arrow) at any time
during the Term in the Territory that may be useful to Sepracor in
Sepracor's Development and Commercialization of the Product in the
Territory.
1.4
"Arrow Patent(s)" shall mean any and all Patents or Patent
Applications Controlled by Arrow (for purposes of clarity,
including Affiliates of Arrow) at any time during the Term in the
Territory with a claim relating to a Product or a component of a
Product, or a method of manufacture or Formulation of any of the
foregoing, or a method of treatment using any of the foregoing. The
Arrow Patents in the Territory existing on the Effective Date are
identified on Schedule 1.4 , as it may be amended from
time
to time. For
the avoidance of doubt, an inclusion with respect to any Arrow
Patent coming into existence after the Effective Date shall occur
automatically upon the first filing of a provisional or
non-provisional application in respect of such Arrow Patent in the
Territory, and the subsequent amendment of Schedule 1.4
shall only serve declaratory purposes.
1.5
"Arrow Technology" means the Arrow Know-How and the Arrow
Patents, collectively.
1.6
"Business Day" means any day on which banking institutions
in the Commonwealth of Massachusetts, United States are open for
business.
1.7
"Change of Control" with respect to a Party means
(i) the acquisition (directly or indirectly, whether by
merger, consolidation, purchase and sale, share exchange or
otherwise) by any Third Party (other than an Affiliate or any trust
or fund created under a profit-sharing or other benefit plan for
employees of such Party) of a beneficial interest in the securities
of such Party representing more than fifty percent (50%) of the
combined voting power of such Party's then outstanding securities;
or (ii) the transfer, sale or assignment of more than fifty
percent (50%) of the assets of such Party to a Third Party other
than an Affiliate of such Party; or (iii) any other transfer
to a Third Party of the power to control such Party.
1.8
"Commercialization" means any and all activities directed to
importing, marketing, promoting, advertising, distributing,
storing, offering for sale, using and selling a Product, including,
without limitation, the distribution of promotional samples to
targeted prescribers (to the extent applicable), in the Territory,
and conducting Phase IV Studies of Product. When used as a
verb, "Commercialize" means to engage in
Commercialization.
1.9
"Contract Year" means (a) with respect to the first
Contract Year, the period beginning on the Effective Date and
ending on December 31, 2008 (the "First Contract Year"),
(b) with respect to each subsequent Contract Year other than
the last Contract Year, the one (1) year period beginning on
the day following the end of the First Contract Year and each
succeeding one (1) year period thereafter, and (c) with
respect to the last Contract Year, the period beginning on
January 1 of such last Contract Year and ending on the date as
of which this Agreement expires or is terminated (the "Last
Contract Year"). Each Contract Year (other than the First Contract
Year or the Last Contract Year) shall be divided into four
(4) "Contract Quarters" comprised of successive three
(3) month periods. In the First Contract Year, the first
Contract Quarter shall end on the first day following the Effective
Date that is the last day of a Contract Quarter, and in the Last
Contract Year, the last Contract Quarter shall end upon expiration
or termination of the Agreement.
1.10
"Control" or "Controlled" means that a right is
owned, licensed, or otherwise possessed by a Party with the right
to license or sublicense.
1.11
"Development" means the scientific, medical, technical, and
clinical, regulatory and other activities necessary to obtain
Regulatory Approval to Commercialize the Product in the Territory,
including, without limitation, technical development, clinical
development and the preparation, filing, prosecution and
administration of INDs, and/or NDAs, in accordance with a
Development Plan that has been agreed pursuant to the terms and
conditions of this Agreement. When used as a verb, "Develop" means
to engage in Development.
1.12
"Development Costs" means for all studies or activities
performed in accordance with Sepracor's Development Plan for any
Product in the Territory, including the following: (a) all
out-of-pocket costs and expenses incurred ( i.e., paid
to Third Parties or accrued therefor) by Sepracor or any of its
permitted designees, (b) the costs of internal personnel
engaged in the performance of such studies or activities, and
(c) the costs of clinical supplies for such studies or
activities, which costs shall include (i) the clinical supply
price, (ii) out-of-pocket costs and expenses incurred in
purchasing comparator drug and in packaging comparator drug and/or
such Product, as applicable, shipping clinical
2
supplies to
centers, or disposal of clinical supplies, and (iii) actual
costs of packaging clinical samples and comparator drug, as
applicable, if done by a Party.
1.13
"Development Plan" means a plan designed by Sepracor to
achieve the clinical Development of a specific Product or of a
specific Improvement, as may be applicable, including, without
limitation, (i) the budget and nature, number and schedule of
Development activities, (ii) a time schedule for the
implementation of the Development activities concerned,
(iii) all such other issues as may reasonably have to be
addressed under such Development Plan, as it may be amended by
Sepracor from time to time in accordance with this
Agreement.
1.14
"Effective Date" means the date of the execution of this
Agreement by both Parties.
1.15
"FDA" means the U.S. Food and Drug Administration and any
successor agency thereto.
1.16
"First Commercial Sale" shall mean the first sale or other
disposition for value of a Product, in a final dosage form packaged
for the ultimate consumer, to an independent Third Party following
applicable Regulatory Approval, by Sepracor, its Affiliates or
permitted sublicensees.
1.17
"Formulation" or "Formulations" mean the Development of
stable and acceptable preparations, suspensions, or other chemical
mixtures of ingredient, as well as associated studies and analysis
of properties, [**], required to develop INDs for a product,
including the Product, all prepared according to Good Laboratory
Practice Standards ("GLP") and other relevant laboratory practice
standards.
1.18
"GAAP" means the "United States Generally Accepted
Accounting Principles" as determined by the US Financial Accounting
Standards Board (FASB).
1.19
"Gross Sales" means, with respect to any applicable period
and any Product, the gross amounts invoiced by Sepracor or an
Affiliate to unrelated Third Parties for sales of such
Product.
1.20
"Improvement" means any Know-How, including, without
limitation, findings, discoveries, inventions, additions,
modifications, formulations or changes, whether patentable or not,
made and Controlled by either Party during the Term insofar as such
Improvement relates to a Product.
1.21
"IND" means an investigational new drug application
submitted to the FDA in respect of a new drug.
1.22
"Know-How" means all scientific, medical, technical,
clinical, regulatory, marketing and other information relating to a
Product that is Controlled by a Party hereto, and that is in
existence as of the Effective Date or comes into existence during
the Term.
1.23
"NDA" means (a) a new drug application submitted to the
FDA pursuant to 21 U.S.C. Section 355(b)(1), or any successor
application or procedure and (b) all supplements and
amendments, including supplemental new drug applications that may
be filed with respect to the foregoing (each, a "SNDA").
1.24
"Net Sales" means, with respect to any period, the Gross
Sales of the Product, less items recognized under GAAP, including,
but not limited to, the following deductions to the extent included
in the gross invoiced sales price for the Product or otherwise
directly paid or incurred by Sepracor, its permitted Affiliates and
its permitted sublicensees with respect to the sale of the Product
and not otherwise recoverable by the paying party: (a) trade,
quantity, or cash discounts, chargebacks, returns, allowances or
rebates and actually allowed, given or accrued in the ordinary
course of trading (including, but not limited to, cash,
governmental and managed care rebates, hospital or other buying
group chargebacks); (b) adjustments, rejections, recalls and
returns to the extent made in the ordinary course of trading, to
the extent the customer has been credited the original sales price
or a portion thereof; (c) sales, excise, turnover, inventory,
value-added, customs duties and similar taxes and governmental
charges assessed on the sale of the Product; and (d) the
portion of any management fees
3
paid during the
relevant time period to group purchasing organizations that relate
specifically to the sale of such Product to such organizations,
(e) any royalties payable by Sepracor to Third Parties in
order to enable Sepracor to commercialize the Product in the
Territory, (f) service fees paid or allowances conceded to
wholesalers pursuant to distribution services agreements or similar
contracts by and between Sepracor and wholesalers for logistic and
other services such as, without limitation,
stock-keeping.
Sales,
transfers or dispositions of the Product for charitable,
promotional (including samples), pre-clinical, clinical, or
regulatory purposes with respect to which no consideration is
received by Sepracor or its Affiliates, shall be excluded from Net
Sales, as shall sales or transfers of the Product among a Party and
its Affiliates.
Upon
any sale or other disposal of any Product for any consideration
other than an exclusively monetary consideration on bona
fide arm's length terms then, for the purposes of calculating
the Net Sales under this Agreement, such Product shall be deemed to
be sold exclusively for money at the fair market price generally
achieved for such Product in the Territory.
Any
discounts or allowances made by Sepracor outside the ordinary
course of trading shall not be accounted for in determining
Sepracor's Net Sales. For clarity and without limitation, this
shall apply to direct and indirect discounts and allowances to
customers regarding the Product associated with product bundling
and selling the Product in combination with other Sepracor products
(so called "package deals"). Upon any sale or other disposal of any
Product for any consideration outside the ordinary course of
trading, for the purposes of calculating the Net Sales under this
Agreement, the Product shall be deemed to be sold exclusively for
money at the fair market price generally achieved in bona
fide arm's length trading for such Product in the Territory
when such Product is sold alone, and not with or in combination
with products other than the Product.
1.25
"Patents" shall mean all existing patents and patent
applications and all patent applications hereafter filed,
including, without limitation, any continuations,
continuations-in-part, divisions, reissues, reexaminations, utility
models, provisionals or substitute applications, any patent issued
with respect to any such patent applications, any reissue,
reexamination, renewal, amendment or extension (including any
supplementary protection certificate and any patent term extension)
of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all
foreign counterparts of any of the foregoing.
1.26
"Person" means any individual, corporation, partnership,
association, joint-stock company, trust, unincorporated
organization or government or political subdivision
thereof.
1.27
"Product" means Arrow's levalbuterol/ipratropium combination
inhalation solution product in current and all future formulations
and delivery modes, any Additional Product and any Improvement to
the foregoing.
1.28
"Regulatory Approval" shall mean that all approvals, price
approvals or approvals for reimbursements, product and/or
establishment licenses, registrations, permits, or authorizations
of any federal, state or local regulatory agency, department,
bureau or other governmental entity or Regulatory Authority,
necessary for the manufacture, packaging, distribution, use,
storage, importation, export, transport, marketing and sale of the
Product for therapeutic use in humans in a country of the Territory
have been obtained.
1.29
"Regulatory Authority" shall mean any national,
supra-national, regional, state or local regulatory agency,
department, bureau or other governmental entity in the Territory
responsible for issuing any technical, medical and scientific
licenses, registrations, authorizations and/or approvals of the
Product including any marketing authorizations based upon such
approvals and pricing, third party reimbursement or labeling
approvals that are necessary for the manufacture, distribution,
use, storage, importation, export, transport and sale of a Product
in a country of the Territory.
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1.30
"Territory" shall mean the world.
1.31
"Third Party" shall mean any Person other than the Parties
and their Affiliates.
1.32
"Trademark" shall mean any trademark used in connection with
the Commercialization of a Product.
Article 2 Grant
of Rights
2.1
Exclusive License Grant.
During the Term, Arrow grants to Sepracor
the exclusive right and license under the Arrow Patents and Arrow
Know-How to Develop, have Developed, market, have marketed, use,
have used, Commercialize, have Commercialized, distribute, have
distributed, offer for sale, sell and have sold the Product in the
Territory and to package, distribute, sell, market and promote the
Product in and throughout the Territory, including the right to
grant sub-licenses, subject to all of the terms and conditions of
this Agreement. Such right and license in the Territory shall be
exclusive even as to Arrow, except to the extent necessary to
enable Arrow to perform any obligations or activities that Arrow is
required or permitted to perform under this Agreement. The license
is subject to Arrow's right of manufacture in
Section 10.1.
2.2
Further Assurances.
Arrow hereby agrees that it will do all
such acts and execute all such further documents, conveyances,
deeds, assignments, transfers, licenses and the like, and will
cause the doing of all such acts on its own behalf and by each of
its Affiliates and will cause the execution of all such further
documents on its own behalf and by each of its Affiliates as are
within its power as Sepracor may from time to time reasonably
request be done and/or executed in order to consummate the
transactions contemplated under this Agreement, as may be necessary
or desirable to effect the purposes of this Agreement, or as may be
appropriate to more effectively carry out and vest in Sepracor the
grant of rights and licenses intended to be made under this
Agreement, all at the sole cost and expense of Arrow.
Article 3 Development
3.1