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Exhibit
10.4
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
LICENSE
AGREEMENT
between
ARIUS TWO,
INC.
and
ARIUS PHARMACEUTICALS,
INC.
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
LICENSE
AGREEMENT
This License Agreement (the
“Agreement”) is made as of September 5, 2007 (the
“Effective Date”) by and between Arius Two, Inc., a
Delaware corporation with its principal office at 2501 Aerial
Center Parkway, Suite 205, Morrisville, NC 27560 (“Arius
Two”), and Arius Pharmaceuticals, Inc., a Delaware
corporation with a mailing address at P.O. Box 14501, Research
Triangle Park, NC 27709 (“Arius”). Arius Two and Arius
are sometimes referred to collectively herein as the
“Parties” or singly as a
“Party.”
RECITALS
WHEREAS , Arius Two
wishes to grant to Arius, and Arius wishes to obtain from Arius
Two, an exclusive license in the United States, Canada, and Mexico,
with rights to sublicense, under Arius Two’s BEMA Technology
to develop, manufacture (or have manufactured), market, advertise,
promote, distribute, offer for sale, sell, export, and import the
Product on the terms and subject to the conditions set forth
herein.
NOW, THEREFORE , in
consideration of the foregoing recitals and the mutual covenants
and agreements contained herein, the Parties hereto, intending to
be legally bound, do hereby agree as follows;
AGREEMENT
ARTICLE I
DEFINITIONS
Section 1.01
Definitions . The following terms as used in this
Agreement shall have the meaning set forth below:
“Additional
Product” means each additional Product to be sold in a
Commercial Sale after the First Commercial Sale of the First
Product and the Second Product.
“ADE” means any
adverse event associated with the Product or the Demonstration
Samples (including adverse drug experiences, as defined in
Applicable Laws).
“Affiliate” means
an individual, trust, business trust, joint venture, partnership,
corporation, association or any other entity which owns, is owned
by or is under common ownership with, a Party. For the purposes of
this definition, the term “owns” (including, with
correlative meanings, the terms “owned by” and
“under common ownership with”) as used with respect to
any Party, shall mean the possession (directly or indirectly) of
more than 50% of the outstanding voting securities of a corporation
or comparable equity interest in any other type of
entity.
“Annual Net
Sales” means the aggregate Net Sales in any calendar
year.
“API” means an
active pharmaceutical ingredient.
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“Applicable Laws”
means all applicable laws, rules, regulations and guidelines that
may apply to the development, marketing, manufacturing or sale of
the Product in the Territory or the performance of either
Party’s obligations under this Agreement including laws,
regulations and guidelines governing the import, export,
development, marketing, distribution and sale of the Product in the
Territory, to the extent relevant, and including all cGMP or Good
Clinical Practices standards or guidelines promulgated by the FDA
or other Competent Authorities and including trade association
guidelines, where applicable, as well as United States’
export control laws and the United States’ Foreign Corrupt
Practices Act.
“BEMA” means
Arius Two’s proprietary bioerodible, mucoadhesive multi-layer
polymer film.
“BEMA Know-How”
means all Know-How related to BEMA which is under the Control of
Arius Two as of the Effective Date, or is created or acquired by,
or under the Control of, Arius Two during the Term including, but
not limited to, data and documentation of clinical trials,
pharmacological, toxicological, clinical, assay, control, and
manufacturing data, techniques, processes, methods, or systems, and
any other information relating to BEMA, all as of the Effective
Date and during the Term, which is not covered by the BEMA Patent
Rights, but is or would be necessary or useful to develop,
manufacture (or prepare for the manufacture of), or commercialize a
Product.
“BEMA Patent
Rights” means all Patent Rights in the Territory related to
the patents and patent applications listed on Exhibit A ,
claiming BEMA or any Improvement, or which are necessary or
appropriate to develop, manufacture and commercialize Products in
the Territory, and that are under the Control of Arius Two as of
the Effective Date or that come under Arius Two’s Control
during the Term.
“BEMA Technology”
means the BEMA Patent Rights and the BEMA Know How.
“Books and
Records” means, in whatever media, any and all books and
records, reports and accounts and data in connection with or
related to a Product, Competent Authorities, Applicable Laws or
this Agreement. Books and Records shall also include any market
research and competitive reports, marketing reports and
data.
“CDC” shall mean
CDC IV, LLC.
“CDC Agreement”
shall mean that certain Clinical Development and License Agreement,
dated July 14, 2005, among BioDelivery Sciences International,
Inc., Arius and CDC, as amended.
“Combination
Product” means a Product that is sold together with any other
products and/or services within the Territory at a unit price,
whether packaged together or separately with another pharmaceutical
product or other device, equipment, instrumentation, or other
components (other than solely containers or packaging exclusively
for the Product).
“Commercial Sale”
means the sale for use, consumption or resale of each Product in
the Territory by Arius, its Affiliate, or its sublicensee. A sale
to an Affiliate or a sublicensee shall not constitute a Commercial
Sale unless the Affiliate or sublicensee is the end user of the
Product.
2
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“Commercially
Reasonable Efforts” shall mean, except as otherwise
explicitly set forth in this Agreement, those efforts consistent
with the exercise of prudent scientific and business judgment, as
applied to products having comparable market potential within the
relevant product lines of that Party and generally accepted
practices in the pharmaceutical industry. “Comparable market
potential” shall be fairly determined by a Party in good
faith and without limitation may be based upon market size, price,
competition, patent rights, product liability issues and general
marketing parameters.
“Competent
Authorities” means collectively the governmental entities in
the Territory responsible for the regulation of medicinal products
intended for human use.
“Confidential
Information” means any confidential or proprietary
information of a Party, whether in oral, written, graphic or
electronic form. Confidential Information shall not include any
information which the receiving Party can prove by competent
evidence:
(a) is now, or hereafter
becomes, through no act or failure to act on the part of the
receiving Party, generally known or available;
(b) is known by the receiving
Party at the time of receiving such information, as evidenced by
its written records maintained in the ordinary course of
business;
(c) is hereafter furnished to
the receiving Party by a Third Party, as a matter of right and
without restriction on disclosure;
(d) is independently
developed by the receiving Party, as evidenced by its written
records maintained in the ordinary course of business, without
knowledge of, and without the aid, application or use of, the
disclosing Party’s Confidential Information; or
(e) is the subject of a
written permission to disclose provided by the disclosing
Party.
“Control” means
the possession of the ability to grant a license or sublicense as
provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
“CPI” means the
Consumer Price Index for All Urban Consumers, All Items, U.S.A.
Area, 1982-1984 = 100, as published by the Bureau of Labor
Statistics, United States Department of Labor (U.S. City Average).
If such index is discontinued, CPI shall then mean the most nearly
comparable index published by the Bureau of Labor Statistics or
other official agency of the United States government.
“Demonstration
Samples” means Units, absent their applicable active
ingredient, used to demonstrate the manner in which the Product is
prepared and used, and labeled “demonstration samples, for
demonstration purposes only, not for human use.”
“Development
Costs” means the directly allocable and documented
out-of-pocket and internal costs of research and development (but
not capital costs) incurred by Arius, or Arius Two at Arius’
written request, in conducting the Parties’ respective work
under this Agreement.
3
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“Effective Date”
means September 5, 2007.
“FDA” means the
Food and Drug Administration, the governmental entity responsible
in the United States for the regulation of medicinal products
intended for human use.
“Fentanyl
Product” means the first Product containing Fentanyl, used
for the treatment of pain and sold in a Commercial Sale.
“First Commercial
Sale” means the first Commercial Sale of each
Product.
“First Product”
means the first Product to be sold in a Commercial Sale.
“GAAP” means
generally accepted accounting principles of the United States
consistently applied on a basis consistent throughout the periods
indicated and consistent with each other.
“Good Clinical
Practices” means good clinical practices as defined in 21 CFR
§ 50 et seq. and § 312 et seq.
“Governmental
Approval” means all permits, licenses and authorizations,
including but not limited to, import permits and Marketing
Authorizations required by any Competent Authority as a
prerequisite to the manufacturing, marketing or selling of the
Product or the Units for human therapeutic use in the
Territory.
“Improvements”
means any and all developments, inventions or discoveries directly
relating to the BEMA Technology developed or acquired by, or under
the Control of, a Party at any time during the Term and shall
include, but not be limited to, such developments intended to
enhance the safety and/or efficacy of any Product.
“IND Application”
means any Investigational New Drug Application filed with the FDA
for marketing approval for a drug pursuant to the Federal Drug and
Cosmetic Act (21 U.S.C. Section 321, et seq.) and the
regulations promulgated thereunder, including any amendments or
supplements thereto.
“Know-How” means
all know-how, trade secrets, inventions, data, processes,
techniques, procedures, compositions, devices, methods, formulas,
protocols and information, whether or not patentable, which are not
generally publicly known, including, without limitation, all
chemical, biochemical, toxicological, and scientific research
information, whether in written, graphic or video form or any other
form or format.
“Marketing
Authorization” means all necessary and appropriate regulatory
approvals, including but not limited to, variations thereto, and
Pricing and Reimbursement Approvals to put the Product on the
market in a particular jurisdiction in the Territory.
“Marks” means
“BEMA” or any additional trademarks owned by Arius Two
with respect to the BEMA Technology, alone or accompanied by any
logo or design and any non-English language equivalents in figure,
sound or meaning, whether registered or not.
4
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“NDA” means a new
drug application and all amendments and supplements thereto, and
all additional documentation required to be filed with the FDA or
other Competent Authority for approval to commence commercial sale
of a Product in the Territory for human therapeutic use.
“Net Sales” means
the gross amounts invoiced by Arius, its Affiliates or sublicensees
for sales of the Product in the Territory by Arius, its Affiliates,
or its sublicensees, as applicable, to a Third Party in a bona fide
arm’s length transaction, less the following items:
*** .
A Product shall be considered
sold when billed out or invoiced. Components of Net Sales shall be
determined in the ordinary course of business in accordance with
historical practice and using the accrual method of accounting in
accordance with GAAP.
In the event Arius transfers
Product to a Third Party in the Territory in a bona fide
arm’s length transaction, for consideration, in whole or in
part, other than cash or to a Third Party in other than a bona fide
arm’s length transaction, *** .
“Packaging” means
any and all containers, cartons, shipping cases, inserts, package
inserts or other similar material, including instructions for use,
used in packaging or accompanying the Product.
“Patent Rights”
means all rights under patents and patent applications, and any and
all patents issuing therefrom (including utility, model and design
patents and certificates of invention), together with any and all
substitutions, extensions (including supplemental protection
certificates), registrations, confirmations, reissues, divisionals,
continuations, continuations-in-part, re-examinations, renewals and
foreign counterparts of the foregoing, and all improvements,
supplements, modifications or additions.
“Phase I” means
the initial introduction of the Product as an investigational new
drug into humans designed to determine the metabolism and
pharmacologic actions of the Product in humans, the side effects
associated with increasing doses and, if possible, to gain early
evidence on effectiveness, and also includes studies of drug
metabolism, structure-activity relationships and mechanism of
action in humans.
“Phase II” means
a controlled clinical study conducted to evaluate dose and obtain
preliminary data on the effectiveness of the Product for a
particular indication or indications in patients with the disease
or condition under study and to determine the common short-term
side effects and risks associated with the Product.
“Phase III” means
an expanded controlled or uncontrolled clinical trial performed
after preliminary evidence suggesting effectiveness of the Product
has been obtained, in order to gather the additional information
about effectiveness and safety that is needed to evaluate the
overall benefit-risk relationship of the Product and to provide an
adequate basis for physician labeling.
“Phase IV” means,
as applicable, a study or program designed to obtain additional
safety or efficacy data, detect new uses for or abuses of a
Product, or to determine effectiveness for labeled indications
under conditions of widespread usage, which is commenced after
regulatory approval of a Product.
5
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“Pricing and
Reimbursement Approvals” means any pricing and reimbursement
approvals which may or must be obtained before placing a Product on
the market in a particular jurisdiction in the
Territory.
“Prime Rate of
Interest” means the prime rate of interest published from
time to time in the Wall Street Journal as the prime rate;
provided, however that if the Wall Street Journal does not publish
the Prime Rate of Interest, then the term “Prime Rate of
Interest” shall mean the rate of interest publicly announced
by Bank of America, N.A., as its Prime Rate, Base Rate, Reference
Rate or the equivalent of such rate, whether or not such bank makes
loans to customers at, above, or below said rate.
“Product” means
individually and collectively any product which, but for the
licenses granted under this Agreement, would infringe one or more
valid claims of the BEMA Patent Rights.
“Product
Development” shall mean Arius’ use of commercially
reasonable efforts to take, at its sole cost and expense or
together with a strategic partner or sublicensee, all actions
reasonably necessary in connection with the development of a
Product including but not limited to (a) any formulation,
chemistry, toxicology, or other research and development activities
reasonably related to the development of a Product, (b) all
preclinical and clinical studies, including Phase I, Phase II,
Phase III, and/or, if and as appropriate, Phase IV studies, and
(c) preparation, organization, and filing of regulatory
documents, including the NDAs for such Product with the
FDA.
“Product Recall”
means any recall, market withdrawal, or correction of a Product
from or in the Territory.
“Royalty” means
the royalty to be paid by Arius to Arius Two as set forth in
Article IV.
“Royalty Term”
means on a Product-by-Product basis the period of time commencing
on the First Commercial Sale of each Product in the Territory and
ending on the expiration of the last to expire of the BEMA Patent
Rights covering such Product in the Territory.
“Second Product”
means the second Product to be sold in a Commercial
Sale.
“Sublicense
Revenue” means
(a) all license fees,
sublicense fees, license option payments (whether in relation to
the grant or exercise of any license option), milestone payments,
and royalties on sales of the *** , the Marks and any other
kinds of revenue whatsoever received (including value received in
the form of securities) by Arius, and/or an Affiliate of Arius, in
respect of the grant to Third Parties of sublicenses in the
Territory *** , or the right to manufacture, sell or
distribute, in the Territory, *** ;
(b) any net manufacturing
profits (defined as revenues from applicable manufacturing less
fully-burdened manufacturing and supply costs) realized by Arius,
and/or an Affiliate of Arius, on any supply, in the Territory,
*** ;
6
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
(c) research and development
payments received by Arius, and/or any Affiliate of Arius, in
connection with its performance under a development program for any
Product in the Territory, where such payments are made other than
for reimbursement of costs and expenses incurred by Arius, and/or
an Affiliate of Arius, at full-time equivalent rates equal to or
below the following (as adjusted annually for percentage increases
or decreases in CPI), with the amounts paid above such full-time
equivalent rates considered Sublicense Revenue:
(i) $ *** per hour for
Vice President level employees and above;
(ii) $ *** per hour
for Director level employees;
(iii) $ *** per hour
for supervisor level employees;
(iv) $ *** per hour
for non-supervisor, laboratory, or regulatory
associates;
(v) actual reasonable market
expenses for non-Affiliate consultants.
(d) any amount in excess of
fair market value paid by a subscriber for stock of Arius and/or
its Affiliates as consideration for the grant of a sublicense in
the Territory or right to manufacture, sell or distribute, in the
Territory, *** (a “Premium Equity
Payment”);
(i) where Arius or one of its
Affiliates is publicly listed on a recognized stock exchange, the
premium paid over the average closing price of such stock of Arius
or its Affiliates, for the 30 trading day period immediately prior
to any such subscription; or
(ii) where Arius, and/or an
Affiliate of Arius, is not publicly listed on a recognized stock
exchange, the premium paid over the fair market value of such stock
as reasonably determined by the board of directors of Arius, and/or
an Affiliate of Arius, in good faith and certified in a resolution
of such board taking into account *** .
If Arius Two disagrees with
*** , and provides written notice thereof to Arius, then the
Parties shall attempt to agree on such value in good faith without
the use of appraisers. If the Parties are unable to so agree within
the 21 days immediately following the giving of such written
notice, then each Party shall select an independent, neutral
appraiser experienced in the business of evaluating or appraising
the market value of stock. *** .
Notwithstanding the
foregoing, Third Party Royalties for a particular Product shall be
deducted from Sublicense Revenue for such Product for purposes of
calculating the amount due Arius Two pursuant to Section 4.03,
provided, however, that in no event shall the total deduction of
Third Party Royalties in any calendar quarter exceed *** %
of Sublicense Revenue as computed without such
deductions.
“Territory” means
the United States (incliding its territories and possessions,
including the Commonwealth of Puerto Rico), Canada, and
Mexico.
7
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“Third Party”
means any entity other than: (a) Arius Two, (b) Arius or
(c) an Affiliate of Arius Two or Arius.
“Third Party
Royalties” means royalties paid by Arius to a Third Party for
a particular Product on a Product-by-Product basis (other than an
Affiliate of Arius) in respect of a third party patent or patent
application to which Arius is required to obtain a license (and, in
the absence of such license, would be infringed by the practice of
BEMA Technology as determined as set forth in Section 4.01(d))
for such Product, provided that any royalties required to practice
BEMA Technology with respect to a specific API, as opposed to BEMA
Technology generally, or a technology not related to BEMA, shall
not be deemed Third Party Royalties hereunder.
“Unit” means the
Product and its Packaging. The Packaging may be changed or
reformulated by Arius from time to time and the term
“Unit” shall refer to the Product in such changed or
reformulated package.
“United States”
means the United States of America, its territories and
possessions, including the Commonwealth of Puerto Rico.
Section 1.02
Defined Terms . Each of the following terms is
defined in the Section set forth opposite such term
below:
|
|
|
| Agreement |
|
Preamble |
| Arius |
|
Preamble |
| Arius
Two |
|
Preamble |
| Audited
Party |
|
Section 15.12 |
| Calculation
Error |
|
Section 15.12 |
| Clinical
Documentation |
|
Section 2.04(a) |
| Competing
Product |
|
Section 12.10(a) |
| Disputed
Amount |
|
Section 14.03(b) |
| Effective
Date |
|
Preamble |
| Force
Majeure |
|
Section 15.03 |
| Improving
Party |
|
Section 3.04(a) |
| Indemnitee |
|
Section 11.03 |
| Indemnitor |
|
Section 11.03 |
| Initiating
Group |
|
Section 15.01 |
| License |
|
Section 3.02 |
| Loss |
|
Section 11.01 |
| Minimum
Royalties |
|
Section 4.04 |
| Other
Group |
|
Section 15.01 |
| Parties |
|
Preamble |
| Party |
|
Preamble |
| Requesting
Party |
|
Section 15.12 |
| Results |
|
Section 2.04(a) |
| Royalty
Statement |
|
Section 4.07(a) |
| Third Party
Claim |
|
Section 7.04 |
8
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
Section 1.03
Interpretation . The Section headings contained in
this Agreement are for reference purposes only and shall not affect
the meaning or interpretation of this Agreement. Except where the
context clearly requires to the contrary: (a) each reference
in this Agreement to a designated “Section” or
“Exhibit” is to the corresponding Section or Exhibit of
or to this Agreement; (b) instances of gender or
entity-specific usage (e.g., “his” “her”
“its” “person” or “individual”)
shall not be interpreted to preclude the application of any
provision of this Agreement to any individual or entity;
(c) “including„ shall mean “including,
without limitation”; (d) references to Applicable Laws
shall mean such Applicable Laws in effect during the Term (taking
into account any amendments thereto effective at such time without
regard to whether such amendments were enacted or adopted after the
Effective Date); (e) references to “$” or
“dollars” shall mean the lawful currency of the United
States; (f) references to “Federal” or
“federal” shall be to laws, agencies or other
attributes of the United States (and not to any State or locality
thereof); (g) the meaning of the terms “domestic”
and “foreign” shall be determined by reference to the
United States; (h) references to “days” shall mean
calendar days; (i) references to months or years shall be to
the actual calendar months or years at issue (taking into account
the actual number of days in any such month or year); and {j) days,
business days and times of day shall be determined by reference to
local time in Denver, Colorado.
Section 1.04
Scope . All definitions herein, and all right, title,
claim, interest, obligation and duty of the parties (including CDC)
under this Agreement shall only pertain to, concern, and be
effective with respect to, the United States, Canada, and Mexico,
whether or not any specific clause, section or portion of this
Agreement (including any term, definition, obligation (including
indemnification obligations), covenant, representation or warranty
of the parties) specifically makes reference to, or is qualified
by, the word “Territory”.
9
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
ARTICLE II
DEVELOPMENT
Section 2.01 Arius
Obligations .
(a) Arius shall use
Commercially Reasonable Efforts to pursue Product Development for
the Fentanyl Product. Notwithstanding the exclusivity provisions of
Sections 3.02(a) and 3.03, if Arius fails to perform in accordance
with the covenant contained in this Section 2.01(a), the
rights granted to Arius with respect to the Mark and the License
(as defined below) will become nonexclusive, effective ***
following written notice to Arius from Arius Two, and Arius Two
may, effective *** following written notice to Arius,
terminate the rights granted to Arius with respect to the Mark and
the License, for all applications of the Fentanyl Product involving
the treatment of pain, which remedy shall be in addition to all
other remedies Arius Two may have at law or in equity. Arius Two
shall (i) provide CDC with a copy of such notice
simultaneously with the provision of such notice to Arius and
(ii) notwithstanding the lapse of *** subsequent to the
notice provided to Arius, provide CDC an opportunity to remedy such
failure to perform within *** of the expiration of the
*** notice to Arius. No remedy available to Arius Two under
Section 2.01(a) shall be effective prior to the lapse of such
*** grace period granted to CDC. If CDC or Arius cures any
failure by Arius to perform in accordance with the covenant
contained in Section 2.01(a), such performance shall be deemed
a cure of the failure by Arius to perform.
(b) Arius shall provide Arius
Two with written reports regarding the status and progress of the
clinical development of the Fentanyl Product at least once per
quarter until such time as the Fentanyl Product is approved by the
FDA, which reports shall be delivered no later than ***
following the end of the applicable quarter.
(c) Arius shall maintain
Books and Records in connection with its Product Development for
the Fentanyl Product in accordance with Applicable Laws and
otherwise in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes, including to obtain
Governmental Approvals, and shall properly reflect all work done
and results achieved by Arius in the performance of Product
Development for the Fentanyl Product in such Books and Records.
Arius Two has the right to audit and inspect the materials in such
Books and Records pursuant to Section 15.12 for the sole
purposes of verifying Arius’ compliance with its obligations
under Section 2.01(a), and Arius shall promptly provide copies
of such Books and Records to Arius Two upon request.
Section 2.02 Arius
Two Obligations . Arius Two shall, at Arius’ cost and
expense, assist Arius in any reasonable manner with respect to
Government Approvals, as shall be reasonably requested by Arius as
necessary to enable Arius to manufacture, sell, use, offer for
sale, distribute, and market Products in the Territory under this
Agreement, including but not limited to the assignment to Arius of
any Government Approvals in the Territory and provision and/or
obtaining of appropriate correspondence, clearance or transfer
letters, or any other form of authorization, license, permit, or
the like from regulatory authorities with respect to Government
Approvals in the Territory. The costs and expenses incurred by
Arius Two under the preceding sentence shall be reimbursed to Arius
Two by Arius as provided in Section 2.05. Arius shall
have
10
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
the right to make amendments to the
Government Approvals in the Territory, make additional applications
thereunder, conduct such studies, or undertake any and all such
actions as are necessary in order to maintain and apply for any
marketing or product approvals, licenses, registrations or
authorizations in the Territory with respect to Products. Upon
Arius Two’s written request, Arius shall provide Arius Two
with copies of any such documents that relate to the Fentanyl
Product, including without limitation all amendments to the
relevant Governmental Approvals in the Territory, any additional
applications, and the results of any such studies.
Section 2.03
Availability of Resources . Arius shall maintain
facilities and/or enter into contractual relationships as are
consistent with generally accepted practices in the pharmaceutical
industry in order to carry out, or ensure the carrying out of,
Product Development of the Fentanyl Product.
Section 2.04
Regulatory and Clinical Documentation .
(a) Subject to Sections 2.01,
3.02, 3.04 and 14.05, Arius will own or retain access to all
documentation, including all notes, summaries and analyses related
thereto, developed in connection with such clinical trials and
regulatory submissions (the “Clinical Documentation”)
and the results of such clinical testing (the
“Results”); provided that Arius shall provide Arius Two
with copies of all such Clinical Documentation and Results that
relate to the Fentanyl Product in the Territory upon reasonable
advance request. The parties agree that the Clinical Documentation
and Results generated by any sublicensee of Arius with respect to
the Territory will, to the extent provided in the relevant
sublicense, be the property of such sublicensee; provided, however,
that (i) Arius shall provide Arius Two with copies of all such
Clinical Documents and Results in Arius’ possession that
relate to the Fentanyl Product upon reasonable advance request and
(ii) Arius shall, if and as reasonably requested by Arius Two
in writing, use commercially reasonable efforts to obtain any
sublicensee’s Clinical Documentation or Results with respect
to the Territory not in Arius’ possession and, upon
Arius’ receipt thereof, provide such Clinical Documentation
and Results to Arius Two.
(b) Arius shall maintain
Books and Records in connection with Product Development of the
Fentanyl Product in the Territory in accordance with Applicable
Laws and in reasonably sufficient detail and a scientific manner
appropriate for regulatory purposes, including to obtain
Governmental Approvals. Arius Two will have the right to audit and
inspect such Books and Records related to the Fentanyl Product
pursuant to Section 15.12, and Arius shall promptly provide
copies of such Books and Records to Arius Two upon written
request.
(c) Any IND Application, NDA,
or Governmental Approval required by any Competent Authority in the
Territory or prepared, filed or obtained by Arius in the Territory,
or, with respect to the Fentanyl Product in the Territory, to the
extent required under the CDC Agreement, CDC shall be prepared,
filed and obtained in Arius’, or, with respect to the
Fentanyl Product in the Territory, to the extent required under the
CDC Agreement, CDC’s name and shall be owned and controlled
exclusively by Arius.
(d) Notwithstanding anything
to the contrary contained in this Section 2.04, in the event
CDC terminates the CDC Agreement (“CDC Termination”)
and Arius does not exercise, if available, any of its rights to
continue development of the Fentanyl Product, CDC shall
send
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PORTIONS HEREOF
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written notice to Arius Two of such
event (the “CDC Termination Notice”). At the written
request of CDC (the “License Request”), which request
must be sent no later than *** following the date of such
CDC Termination (provided that no written notice from Arius
challenging the termination is delivered to Arius Two within
*** of the date of the CDC Termination Notice), and upon the
cure by CDC of any Arius default under this Agreement (which cure
is effectuated during the applicable grace period set forth
herein), Arius Two shall be deemed to have granted its consent to
and CDC and Arius shall be deemed to have effected: (i) an
assignment by Arius to CDC of all of its right, title, and interest
to all Governmental Approvals, NDAs, Books and Records, Clinical
Documentation, Results, Marketing Authorizations, and Know-How, in
each case solely to the extent directly related to the Fentanyl
Product in the Territory, and (ii) a grant by Arius to CDC of
an exclusive, royalty bearing sublicense under the BEMA Technology
and the Marks to use, develop, market, advertise, promote,
distribute, offer for sale, sell export and import, manufacture and
have manufactured the Fentanyl Product in the Territory, with the
right to sublicense subject to and in accordance with
Section 3.02(b). If a written challenge is delivered to Arius
Two by Arius, there shall be no deemed transfer as set forth above
until Arius Two receives either (i) consent to the transfer
signed by Arius and CDC, or (ii) a court order, final and
without opportunity on the part of Arius or CDC to appeal,
confirming the CDC Termination, or (iii) a binding arbitration
award confirming the CDC Termination. In addition to providing to
Arius Two the CDC Termination Notice and the License Notice, CDC
shall forward to Arius Two any notice of default or intent to
terminate or notice of termination under the CDC Agreement
simultaneously with the provision of notice to Arius. Promptly
after delivery of the License Notice, and in the event that Arius
is in default of this Agreement with respect to the Fentanyl
Product, cure of such default by CDC, each of Arius and CDC shall
enter into separate agreements with Arius Two in a form
substantially the same as the form of this Agreement (including
equivalent financial terms in each of such new licenses at the full
rates or amounts as set out in this Agreement) with such changes as
are reasonable and appropriate in the circumstances to reflect the
separation of rights between CDC and Arius and except
that:
(i) for greater clarity, the
definitions of “First Product”, “Second
Product” and “Additional Product” will relate to
the first, second and subsequent Products, respectively, to be sold
in a Commercial Sale by Arius or by CDC or their Affiliates or
sublicensees;
(ii) the nature of the rights
granted will be defined in the case of the license to Arius to
exclude rights related to the Fentanyl Product and all Clinical
Documentation and Results related thereto, and, in the case of CDC
will be limited to the Fentanyl Product and all Clinical
Documentation and Results related thereto, and all rights to the
BEMA Technology that may have application to the Fentanyl Product
and any other Product will be co-exclusive (instead of exclusive)
between Arius and CDC;
(iii) except for the
additional time granted to CDC under Section 3.02(e), the cure
periods applicable to any breach by Arius or CDC under the
respective new licenses will revert to the cure periods as
specified in the original License and no separate notice of breach
or time to cure shall be given to CDC.
Section 2.05 Costs
and Expenses . Arius shall be responsible for all
Development Costs incurred after the Effective Date. Furthermore,
Arius will reimburse Arius Two for Arius
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CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
Two’s costs and expenses incurred
in satisfying its obligations, if and as requested by Arius,
pursuant to Section 2.02 or 3.02(e) at a rate equal to the FTE
rates listed below for personnel (as adjusted annually for
percentage increases in CPI), and at Arius Two’s actual cost
for all other costs incurred by Arius Two, provided such costs
shall be reasonable and documented. Such reimbursement shall be
paid by Arius within 30 days of its receipt from Arius Two of a
reasonably detailed invoice setting forth such costs and expenses.
For purposes of this Section 2.05, the FTE rates to be charged
by Arius Two shall be as follows:
(a) $ *** per hour for
Director level employees and above,
(b) $ *** per hour for
supervisor level employees,
(c) $ *** per hour for
non-supervisor, laboratory, or regulatory associates.
Arius Two shall keep complete
and accurate books and records pertaining to the Development Costs
incurred at Arius’ request pursuant to this Agreement in
sufficient detail to permit Arius to confirm the accuracy of such
Development Costs. Arius shall have the right to audit and inspect
such Books and Records pursuant to the terms of Section 15.12,
but only to the extent reasonably necessary to confirm the accuracy
of the calculation of the Development Costs.
ARTICLE III
LICENSE
Section 3.01
Intentionally Deleted .
Section 3.02
License Terms . The terms and conditions of the
exclusive license (the “License”) granted to Arius
shall be as follows:
(a) Subject to the terms and
conditions of this Agreement, Arius Two hereby grants to Arius a
sole and exclusive (subject to Section 2.01), royalty-bearing
license under the BEMA Technology to use, develop, market,
advertise, promote, distribute, offer for sale, sell, export and
import, manufacture, and have manufactured Products in the
Territory, with the right to sublicense in accordance with
Section 3.02(b). Subject to the terms of this Agreement, Arius
shall have the right to assign this Agreement, on the basis set
forth in Section 15.02. During the term of this Agreement,
Arius Two shall not grant any right or license to any third party
with respect to the BEMA Technology in the Territory.
(b) Subject to the terms of
this Agreement, Arius shall have the right to grant a sublicense
hereunder to an Affiliate or a Third Party; provided, however, that
any such sublicense agreement (and any subsequent amendments or
revisions thereto) shall be delivered to Arius Two for review and
Arius Two’s approval, which approval shall not be
unreasonably withheld, prior to its execution, provided that Arius
Two shall be deemed to have approved such sublicense agreement if
Arius Two does not, within *** of receiving an approval
request from Arius, provide Arius written notice objecting to such
sublicense agreement, detailing Arius Two’s objections; and
provided, further, that with respect to the Fentanyl Product, such
approval shall be in Arius Two’s sole and absolute
discretion. Further, any such sublicense agreement (or
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CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
any subsequent amendments or revision
thereto) shall (i) be delivered to Arius Two upon execution,
(ii) be consistent with the terms and conditions of this
Agreement, and (iii) impose on the sublicense, as applicable,
payment, confidentiality, reporting, record keeping requirements,
and audit and inspection rights reasonably sufficient to enable
Arius to comply with its corresponding obligations set forth in
this Agreement. The execution of such a sublicense shall not
relieve Arius of its obligations under this Agreement.
(c) Subject to the terms of
this Agreement, Arius shall have the right to enter into a
co-marketing or co-promotion agreement with a Third Party in the
Territory; provided, however, that any such agreement with respect
to co-marketing or co-promoting the Fentanyl Product in the
Territory shall be delivered to Arius Two for review and Arius
Two’s approval, which approval shall not be unreasonably
withheld, prior to its execution, provided that, Arius Two shall be
deemed to have approved such an agreement if Arius Two does not,
within *** of receiving an approval request from Arius,
provide Arius written notice objecting to such agreement, detailing
Arius Two’s objections. Any co-marketing or co-promotion
agreement entered into by Arius pursuant to this
Section 3.02(c) shall not conflict with this Agreement and
shall impose on the comarketer or co-promoter payment,
confidentiality, reporting, record keeping requirements, and audit
and inspection rights sufficient to enable Arius to comply with
this Agreement. Arius shall keep Arius Two reasonably informed of
the status of any negotiations with any such proposed co-marketer
or co-promoter of the Fentanyl Product and shall promptly provide
Arius Two with a copy of any co-marketing or co-promotion agreement
entered into with such co-marketer or co-promoter of the Fentanyl
Product in the Territory. The execution of a co-marketing or
co-promotion agreement shall not relieve Arius of its obligations
under this Agreement.
(d) Arius acknowledges that
it shall have no right, title or interest in or to the BEMA
Technology in the Territory except to the extent set forth in this
Agreement, and Arius Two reserves all rights to use the BEMA
Technology except as otherwise expressly granted to Arius pursuant
to this Agreement. Nothing in this Agreement shall be construed to
grant Arius any rights or license to any intellectual property of
Arius Two other than as expressly set forth herein.
(e) Arius shall prepare and
file with each of the Competent Authorities in each country in the
Territory the appropriate applications and related documents
necessary to obtain Governmental Approval to market and sell the
Fentanyl Product, and, if not the Fentanyl Product, the First
Product, in each country in the Territory in which Arius decides to
market the Fentanyl Product, and, if not the Fentanyl Product, the
First Product. The above and the provisions of Section 2.06
notwithstanding, Arius shall, *** ].
Section 3.03
Trademarks . Subject to the terms and conditions of
this Agreement, Arius Two hereby grants to Arius a sole and
exclusive (subject to Section 2.01), royalty-free license to
use the Marks solely in connection with the use, promotion,
marketing, distribution, offer for sale, and sale of the Products,
on a Product-by-Product basis, in the Territory during the Royalty
Term. Arius may grant a sublicense to the Marks in accordance with
Section 3.02(b). Arius acknowledges that it shall have no
right, title or interest in or to the Marks except to the extent
set forth in the license granted to Arius under this
Section 3.03, and Arius Two reserves all rights to use the
Marks except as otherwise expressly granted to Arius pursuant to
this Agreement.
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CONFIDENTIAL TREATMENT
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PORTIONS HEREOF
DENOTED WITH
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Arius shall use the Marks in the exact
form set forth on Exhibit B , attached hereto, including the
“®” symbol or “TM” symbol, as
applicable. All content or other specific graphic elements provided
by Arius Two shall remain the property of Arius Two and shall be
used only in the manner set forth in this Agreement except as
otherwise previously approved in writing by Arius Two.
Section 3.04
Ownership of Intellectual Property .
(a) Each Party shall own all
right, title and interest in and to any Improvements made by such
Party. During the Term, each Party shall promptly notify the other
Party of Improvements made by such Party (the “Improving
Party”). In addition to any exclusive rights licensed
hereunder and notwithstanding Section 3.04(b), Arius Two shall
grant to Arius a non-exclusive non-royalty-bearing license, with
rights of sublicense, under Improvements made or obtained by, or
under the Control of, Arius Two and any Patent Rights claiming such
Improvements, to use, develop, market, advertise, promote,
distribute, offer for sale, sell, export, import, manufacture, and
have manufactured such Improvements in the Territory. In the event
Arius Two terminates this Agreement pursuant to Sections 14.02 or
14.03 or the License is terminated for any reason, Arius shall
grant to Arius Two a non-exclusive, perpetual, irrevocable
non-royalty-bearing license, with rights of sublicense, under, to
the extent Controlled by Arius, Improvements made by Arius or any
sublicensee of Arius and any Patent Rights claiming such
Improvements, to use, patent, develop, market, advertise, promote,
distribute, offer for sale, sell, export, import, manufacture, and
have manufactured BEMA-based Products in the Territory.
(b) For the avoidance of
doubt and except as specifically set forth in this Agreement, Arius
shall have no right, title or interest in the Territory in or to
the BEMA Technology, the Marks, or Improvements made by Arius Two,
and Arius Two shall have no right, title or interest in or to
Improvements or developments, inventions or discoveries made by
Arius.
Section 3.05
License Following Expiration . After expiration of
the Royalty Term, Arius shall retain a non-exclusive fully-paid and
royalty-free license under the BEMA Know-How, Improvements made or
obtained by, or under the Control of, Arius Two, and Marks to
manufacture, use, import, sell and offer for sale Products in the
Territory.
ARTICLE IV
ROYALTY AND MILESTONE
PAYMENTS
Section 4.01
Royalty Payments on Arius Sales .
(a) Arius shall pay to Arius
Two royalties equal to the following percentages of Net Sales by
Arius, its Affiliates, and its or its Affiliates’
sublicensees of the First Product, for a period equal to the
Royalty Term for the First Product:
(A) *** % of
Annual Net Sales for Annual Net Sales equal to or less than $
*** ;
(B) *** % of
Annual Net Sales for Annual Net Sales more than $ *** and
less than or equal to $ *** ;
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PORTIONS HEREOF
DENOTED WITH
“***”
(C) *** % of
Annual Net Sales for Annual Net Sales more than $ *** and
less than or equal to $ *** ; and
(D) *** % of
Annual Net Sales for Annual Net Sales greater than $ ***
.
(b) Arius shall pay to Arius
Two royalties equal to the following percentages of Net Sales by
Arius or its Affiliates (but not sales by Third Party sublicensees)
of the Second Product (or if the Second Product is not sold by
Arius or its Affiliates, the next Product sold by Arius or its
Affiliates), for a period equal to the Royalty Term for the Second
Product (or if the Second Product is not sold by Arius or its
Affiliates, the next Product sold by Arius or its Affiliates),
respectively:
(A) *** % of
Annual Net Sales for Annual Net Sales equal to or less than $
*** ;
(B) *** % of
Annual Net Sales for Annual Net Sales more than $ *** and
less than or equal to $ *** ;
(C) *** % of
Annual Net Sales for Annual Net Sales more than $ *** and
less than or equal to $ *** ; and
(D) *** % of
Annual Net Sales for Annual Net Sales greater than $ ***
.
(c) Arius shall pay to Arius
Two royalties equal to *** % of Net Sales by Arius or its
Affiliates of any Product(s) for which royalties are not due under
subsections 4.01 (a) or (b) above, for a period equal to
the Royalty Term for each such Product, provided that, for purposes
of this Section 4.01(c), only sales of Products by Arius and
its Affiliates (but not sales by Third Party sublicensees) shall be
considered Net Sales for purposes of calculating the royalty due
under this Section 4.01(c).
(d) If, except for the grant
of a royalty-bearing license to Arius by a Third Party controlling
the rights to a patent (or patent application), the development,
manufacture (or have manufactured), marketing, advertising,
promotion, distribution, offer for sale, sale, export, or import of
a Product would infringe said patent or patent application (if such
application were to issue), as reasonably determined by Arius and
supported by written advice of Arius’ patent counsel, which
counsel shall be reasonably acceptable to Arius Two (a copy of
which, if requested by Arius Two, shall be provided to Arius Two),
Arius may deduct a pro rata amount of any Third Party Royalties
actually paid with respect to such Product from the Royalty owing
to Arius Two for sales of that Product pursuant to Sections
4.01(a), 4.01(b), and 4.01(c) above, provided that (i) in no
event shall the Royalties due Arius Two with respect to such
Product be less than *** % of the royalties that would be
payable to Arius in the absence of any such deduction and
(ii) such deduction will only apply to the Royalties owed by
Arius to Arius Two under Sections 4.01(a), 4.01(b), and 4.01(c)
above with respect to such Product and not any other
Product.
Section 4.02
Intentionally Omitted .
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CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
Section 4.03
Royalty Payments on Sublicensee Sales . Arius shall
pay to Arius Two Royalties equal to *** % of any Sublicense
Revenue.
Section 4.04
Minimum Payments . The aggregate annual Royalty
payments on Net Sales and Sublicense Revenues paid to Arius Two by
Arius pursuant to Sections 4.01 and 4.03, respectively, with
respect to Net Sales made and Sublicense Revenues received during
the time periods set forth on Exhibit C shall not be less
than the minimum amounts set forth in Exhibit C with respect
to the corresponding time periods (the “Minimum
Royalties”). In the event that such aggregate Royalty
payments correspon
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