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Exhibit 10.4
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
FFIS CO-PROMOTION AGREEMENT
by and between
DEY, L.P.
and
CRITICAL THERAPEUTICS, INC.
JUNE 25, 2007
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THIS FFIS CO-PROMOTION AGREEMENT (the "Agreement" or "FFIS
Agreement") is made
as of June 25, 2007 ("Effective Date") by and between CRITICAL
THERAPEUTICS,
INC., a corporation organized and existing under the laws of the
State of
Delaware and having its principal offices at 60 Westview Street,
Lexington, MA
02421 ("CRTX" ) and DEY, L.P., a limited partnership organized
and existing
under the laws of the State of Delaware and having its principal
offices at 2751
Napa Valley Corporate Drive, Napa, CA 94558 ("DEY").
WITNESSETH
WHEREAS, the Parties desire that CRTX engages in the Promotion
(as hereinafter
defined) of the Product (as hereinafter defined) in the
Territory (as
hereinafter defined) in the Field (as hereinafter defined) for a
certain period
of time and the Parties also desire to coordinate CRTX's
activities regarding
the Product with those of DEY, all of which shall be subject to
the terms and
conditions of this Agreement;
WHEREAS, the Parties have previously entered in to that certain
Co-Promotion and
Marketing Services Agreement regarding Zileuton products,
effective March 13,
2007 (the "Zileuton Co-Promotion Agreement"), as well as that
certain Binding
Letter Agreement by and between Dey, L.P. and Critical
Therapeutics, Inc.
effective March 13, 2007, as amended (the "Binding Letter
Agreement"), which
Binding Letter Agreement is superseded by this Agreement,
NOW, THEREFORE, in consideration of the foregoing statements and
the mutual
agreements and covenants herein contained, and for other good
and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the
Parties agree as follows:
AGREEMENT
ARTICLE 1
DEFINITIONS
Unless specifically set forth to the contrary herein, the
following terms, where
used in the singular or plural, shall have the respective
meanings set forth
below:
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1.1 "Act" means the United States Food, Drug, and Cosmetic Act
of 1938, as
amended, and the rules and regulations promulgated thereunder,
or any successor
act, as the same shall be in effect from time to time.
1.2 "Adverse Event(s)" means adverse drug experiences, as
defined by 21 CFR
312.32 or 314.80, relating to a Product. "Serious Adverse
Event(s)" means a
serious Adverse Event, as defined by 21 CFR 312.32 or 314.80,
relating to a
Product. For purposes of Section 6 of this Agreement, the use of
the phrase
"Adverse Event" is intended to include Serious Adverse
Event(s).
1.3 "Affiliate" means (i) any corporation, association or other
entity of which
more than fifty percent (50%) of the voting securities or other
ownership
interests representing the voting equity, the voting stock or
general
partnership interest are owned, controlled or held, directly or
indirectly, by a
Party; or (ii) any corporation, association or other entity
which, directly or
indirectly, owns, controls or holds more than fifty percent
(50%) of the voting
securities or other ownership interests representing the voting
equity, the
voting stock or, if applicable, the general partnership
interest, or the right
to of a Party.
1.4 "Alliance Manager" shall have the meaning set forth in
Section 3.1.
1.5 "Annual Retail Baseline Units" or "ARBU" means, for each
Year, the number of
Retail Units of Product forecasted to be sold by DEY through
retail sales
channels in such Year that are based solely on detailing by
DEY's sales force
only (and no detailing by CRTX's sales force), as set forth in
Schedule 1.5
attached.
1.6 "Applicable Laws" means all applicable federal, state and
local laws,
statutes, rules, regulations and ordinances.
1.7 "Applicable Tier 1 Retail Units" shall have the meaning set
forth in Section
5.1(2).
1.8 "Applicable Tier 2 Retail Units" shall have the meaning set
forth in Section
5.1(3).
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1.9 "Binding Letter Agreement" shall have the meaning set forth
in the Recitals.
1.10 "Business Day" means any day that is not a Saturday or a
Sunday or a day on
which the NASDAQ Global Market is closed.
1.11 "Calendar Quarter" means each of the three month periods
ending March 31,
June 30, September 30 and December 31, provided that the first
Calendar Quarter
shall commence as of the Detail Commencement Date and end on (i)
December 31,
2007 if the Detail Commencement Date is on or after October 1,
2007 or (ii)
September 30, 2007 if the Detail Commencement Date is on or
prior to September
30, 2007.
1.12 "Call" means an in person contact between a Sales
Representative of a Party
and a Detail Target during which a Detail is made to the Detail
Target.
1.13 "CFR" means the United States Code of Federal
Regulations.
1.14 "Claims" means any suits, claims, actions, demands,
complaints, lawsuits or
other proceedings that are brought by any Third Party, including
without
limitation product liability claims and claims seeking to
recover for personal
injury or death, alleged to have been caused, in whole or in
part, by a Product
regardless of the legal theory alleged.
1.15 "Commercial Launch Date" means the date after full FDA
approval of the NDA
for FFIS when FFIS has been produced and is released by DEY for
purchase by
Third Party wholesalers and/or retailers in the Territory.
1.16 "Commercially Reasonable Efforts" means, with respect to
the efforts to be
expended by a Party with respect to any objective, such
reasonable, diligent,
good faith efforts to accomplish such objective as such Party
would normally use
to accomplish a similar objective under similar circumstances
exercising
reasonable business judgment for a product owned by it or to
which it has
rights, which product is of similar market potential, taking
into account
efficacy, safety, approved labeling, the competitiveness of
alternative products
in the marketplace and other relevant factors commonly
considered in similar
circumstances.
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1.17 "CRTX Indemnified Party" shall have the meaning set forth
in Section 11.1.
1.18 "CRTX Trademark(s)" means the trademark and domain names
listed on Schedule
1.14, together with all related common law trademark rights of
CRTX related
thereto.
1.19 "Current Good Manufacturing Practices" or "GMP" or "cGMP"
means the current
good manufacturing practice and standards as provided for (and
as amended or
updated from time to time) in applicable ICH Harmonized
Tripartite Guidelines
and as defined in Parts 210 and 211 of Title 21 of the CFR, as
may be amended
from time to time, or any successors thereto.
1.20 "Detail" means a Call during which relevant characteristics
of the Product
are described by the Sales Representative of a Party aimed at
encouraging the
appropriate use of the Product and using, if necessary or
desirable, the
Promotional Materials. A sample drop shall not be considered a
primary or
secondary Detail. When used as a verb, "Detail" shall mean to
engage in a
Detail.
1.21 "Detail Commencement Date" means the later of the
Commercial Launch Date,
or the date that DEY receives written notice from CRTX
indicating that CRTX has
(a) completed its sales force expansion to the size of 40 or
more Sales
Representatives and all of whom have completed the FFIS launch
training as
contemplated by this Agreement, and (b) that the first Call has
been made by
CRTX's Sales Representatives under the terms of this
Agreement.
1.22 "Detail Targets" means all office-based physicians and
other health care
professionals in the Territory selected by CRTX from the DEY
FFIS Target
Universe. For purposes of this Agreement, the "DEY FFIS Target
Universe" shall
mean the group of office-based physicians and other health care
professionals in
the Territory that DEY uses internally for its Call plan for
FFIS, which group
consists of allergists, pulmonologists, internal medicine
physicians, and
primary care physicians (excluding pediatricians) who belong to
the FFIS Market
Quintile [**] based upon third party data, such as Wolters
Kluwer Health. DEY
shall retain the right to modify the DEY FFIS Target Universe
from time to time;
provided, however, any such modification shall not affect a
previously agreed to
CRTX [**] month Call plan. CRTX will notify DEY of the date of
the next CRTX
Call plan period at least [**] days prior to the start date of
the
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period. DEY, within [**] days after receipt of such notice, will
provide the DEY
FFIS Target Universe to a third party retained by CRTX and
approved by DEY so
that the third party may use it to assist CRTX with its
selection of Detail
Targets for the applicable Call plan. DEY and CRTX acknowledge
and agree that
the DEY FFIS Target Universe for the [**] month period starting
on the Detail
Commencement Date has been finalized by the parties.
For purposes of this Section, the "FFIS Market Quintile" means
the prescriber
quintile based upon the current definition of the FFIS Market
used in DEY's Call
plan.
1.23 "DEY Indemnified Party" shall have the meaning set forth in
Section 11.2.
1.24 "DEY Patents" shall mean those patents listed on Schedule
1.19 attached.
1.25 "DEY Trademarks" shall mean the trademarks listed on
Schedule 1.20
attached.
1.26 "Effective Date" shall have the meaning set forth in the
Preamble.
1.27 "FAPI" shall have the meaning set forth in Section
4.3(6).
1.28 "FDA" means the United States Food and Drug Administration
and any
successor agency having substantially the same jurisdiction and
functions.
1.29 "Field" shall mean the use of the Product as a
pharmaceutical product in
humans for the treatment of chronic obstructive pulmonary
disease ("COPD") or
other respiratory indications for which DEY has received formal
FDA approval.
1.30 "Finished Product" means the formulation of the Product
described in the
specifications included in the NDA for such Product (the "FFIS
Specifications")
and packaged and labeled and in a form ready for distribution in
the Territory.
1.31 "GAAP" means U.S. generally accepted accounting
principles.
1.32 "Indemnified Party" shall have the meaning set forth in
Section 11.3.
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1.33 "Indemnifying Party" shall have the meaning set forth in
Section 11.3.
1.34 "Independent Accountant" shall have the meaning set forth
in Section
5.3(1).
1.35 "Losses" means any and all damages, awards, deficiencies,
settlement
amounts, defaults, assessments, fines, dues, penalties
(including penalties
imposed by any governmental authority), costs, fees,
liabilities, obligations,
taxes, liens, losses, and expenses (including court costs,
interest and
reasonable fees of attorneys, accountants and other experts)
awarded or
otherwise paid or payable to Third Parties.
1.36 "NDA" means a new drug application (as defined in the Act
and applicable
regulations promulgated thereunder, as amended from time to
time) filed with the
FDA, including any supplements or amendments thereto which may
be filed.
1.37 "Net Retail Average Selling Price" shall mean, for any
applicable Calendar
Quarter, the average WAC Price per Retail Unit for such Calendar
Quarter, less
Rebates and Discounts per Retail Unit for such Calendar Quarter.
In the
determination of the Net Retail Average Selling Price, DEY will
use Commercially
Reasonable Efforts to allocate the Rebates and Discounts
relevant to Product
sales to the retail sales channels (and shall not allocate any
Rebates or
Discounts relevant to Product sales to non-retail sales channels
in such
amounts).
1.38 "PDE" is the measure of Detail Calls, and shall mean
primary detail
equivalents calculated as follows: one primary Call is 1.0 PDE
and one secondary
Call is 0.4 PDE.
1.39 "PDMA" means the United States Prescription Drug Marketing
Act of 1987, as
amended, or any successor act thereto, and the regulations
promulgated
thereunder from time to time.
1.40 "Party" means DEY or CRTX. "Parties" means DEY and
CRTX.
1.41 "Patent Office" means the United States Patent and
Trademark Office.
1.42 "Product" or "FFIS" means Formoterol Fumarate Inhalation
Solution
20mcg/2ml, which is
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the subject of DEY's NDA No. 22-007.
1.43 "Product Label(ing)" shall have the same meaning as defined
in the Act and
regulations as interpreted by the FDA.
1.44 "Product Quality Complaint" shall mean any legitimate
complaint (as
reasonably determined by the Party receiving such complaint) by
a Third Party
that (a) questions the purity, identity, potency or quality of
the Product, its
packaging, or labeling, or (b) claims that the Product or its
labeling is
mistaken for, or applied to, another article or any
bacteriological
contamination, or (c) claims a significant chemical, physical,
or other change
or deterioration exists in the distributed drug product, or (d)
claims a failure
of one or more distributed batches of Product to meet the
specifications
thereof.
1.45 "Promotion" means, as regards to the Product, those
activities normally
undertaken by a pharmaceutical company to implement promotion
plans and
strategies aimed at encouraging the appropriate use of a
particular prescription
pharmaceutical product under a common trademark, up to the point
of offering a
product for sale. When used as a verb, "Promote" shall mean to
engage in such
activities.
1.46 "Promotion Expenses" means all actual out-of-pocket
expenses incurred
(i.e., paid or accrued) to a Third Party by or on behalf of DEY
in connection
with selling, marketing and Promotion of the Product in the
Territory, including
the following (but excluding expenses for Samples purchased by
CRTX hereunder,
Third Party market data, such as IMS or Wolters Kluwer Health
data purchased by
CRTX, sales forces of CRTX, and salaries for employees of CRTX
performing
marketing functions):
(a) marketing, advertising, Promoting, and educational expenses,
including
speakers' programs, medical education programs and symposia,
relationships with opinion leaders and professional societies,
public
relations and market research;
(b) training and communications materials and detail and visual
aids;
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(c) Third Party market data from IMS or Wolters Kluwer Health
purchased by
DEY;
(d) implementing marketing programs; and,
(e) preparation, storage and distribution of Promotional
Materials;
provided, however, that Promotion Expenses shall specifically
exclude
salaries and other internal overhead and/or compensation paid
to
either Party's employees, including their respective sales
forces.
1.47 "Promotion Plan" means a plan established by DEY relating
to the Promotion
of the Product.
1.48 "Promotional Materials" means all written, printed or
graphic (or in other
media formats) material provided by DEY and intended for use by
a Party's Sales
Representatives during a Call, or marketing sponsored speaker
programs
including, but not limited to, visual aids, file cards, premium
items, clinical
studies reprints, drug information updates and any other
promotional support
items or advertising that DEY deems necessary or appropriate in
connection with
the Promotion of Product. Promotional Materials shall include
only those
materials describing FDA-approved indicated uses, safety,
effectiveness,
contraindications, side effects, warnings and other relevant
characteristics of
a Product that meet the regulations as outlined in the CFR.
Promotional
Materials also includes all sales training materials, however
promotional
Materials shall not include any Product packaging or Product
labeling or Sample
labeling, or Samples.
1.49 "Proprietary Information" means any and all scientific,
clinical,
regulatory, sales, marketing, financial and commercial
information or data,
customer-related materials, know-how, concepts, ideas, trade
secrets, expertise,
and all of the foregoing regardless of whether communicated in
writing, orally
or by any other means, which is owned and under the protection
of one Party and
is provided by that Party to the other Party in connection with
this Agreement.
1.50 "Quarterly Retail Base Units" or "QRBU" means, for each
Calendar Quarter of
such Year, the Retail Units of Product forecasted by DEY that
are based on
detailing by DEY's sales force only and as set forth in Schedule
1.5 attached.
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1.51 "Rebates and Discounts" means the following deductions to
the extent
actually allowed or taken and not in excess of industry standard
amounts and
determined in accordance with GAAP, DEY's revenue recognition
policies, and
Applicable Laws:
(a) credits or allowances actually granted for damaged or
spoiled Product,
returns, recalls or rejections of Product, and retroactive
price
reductions;
(b) normal and customary trade, cash and quantity discounts,
allowances
and credits, actually given or allowed, as applicable;
(c) sales, value added, excise or similar taxes actually paid or
allowed,
or other governmental charges imposed upon the importation, use
or
sale of Product in the Territory;
(d) legally allowed chargebacks, rebates, fees or similar
payments to
customers, including, but not limited to, managed health
care
organizations, wholesalers, distributors, buying groups,
retailers,
health care insurance carriers, pharmacy benefit management
companies,
health maintenance organizations, or other institutions or
health care
organizations or to federal, state/provincial, local and
other
governments, their agencies and purchasers and reimbursers;
(e) credit card processing charges and fees, freight, postage,
shipping
and insurance charges relating to delivery of the Product;
and,
(f) launch discounts, stocking fees and other discounts actually
extended
to wholesalers.
1.52 "Retail Unit" means one vial of Product. "Retail Units"
means the vials of
Product sold in the retail channel for a given period of time,
as reported in
the script data that DEY purchases from Wolters Kluwer Health or
a similar Third
Party.
1.53 "Sales Representative" means a qualified salesperson
meeting the
requirements set forth in this Agreement, including, but not
limited to Section
4.2 and 4.6 of this Agreement, and who is employed by a
Party.
1.54 "Samples" means Product provided without charge to Detail
Targets and in
compliance
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with Applicable Laws.
1.55 "SEC" means the United States Securities and Exchange
Commission and any
successor agency having substantially the same jurisdiction and
functions.
1.56 "Term" shall have the meaning set forth in Section
12.1.
1.57 "Territory" means the United States of America (including
the District of
Columbia) and all of its territories and possessions now or at
any time during
the Term(s).
1.58 "Third Party(ies)" means a person or entity who or which is
neither a Party
nor an Affiliate of a Party to this Agreement.
1.59 "WAC Price" means DEY's invoice price per Retail Unit of
FFIS to its
wholesalers, which is commonly known as the 'Wholesale
Acquisition Cost' as may
also be published in First Data Bank or other Third Party price
reporting
agencies.
1.60 "Year" means each consecutive twelve-month period starting
January 1 and
ending December 31, provided that the first Year of the Term
shall start on the
Effective Date and end on December 31, 2007.
1.61 "Zileuton Co-Promotion Agreement" shall have the meaning
set forth in the
Recitals.
Where words and phrases are used herein in the singular, such
usage is intended
to include the plural forms where appropriate to the context,
and vice versa.
The words "including", "includes" and "such as" are used in
their non-limiting
sense and have the same meaning as "including without
limitation" and "including
but not limited to". References to Articles, Sections,
subsections, and clauses
are to the same with all their subparts as they appear in this
Agreement.
"Herein" means anywhere in this Agreement. "Hereunder" and
"hereto" means under
or pursuant to any provision of this Agreement.
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ARTICLE 2
GRANT OF RIGHTS
2.1 DEY Grant of Co-Promotion Right. Subject to the terms and
conditions of this
Agreement, DEY hereby grants to CRTX, in the Territory in the
Field and during
the Term, the non-transferable, limited right and license or
sublicense (as
applicable) under the DEY Trademarks and the DEY Patents to
Promote and Detail
FFIS; provided, however, CRTX's exercise of such rights to
Promote and Detail
the Product shall not occur before the Detail Commencement Date.
Notwithstanding
anything to contrary in this Section 2.1, DEY reserves all other
rights to the
DEY Patents and the DEY Trademarks, including, but not limited
to, the right to
Promote and Detail the Product with its sales force in the
Territory during the
Term. All use by CRTX of the DEY Trademarks and the DEY Patents
shall be under
the control of DEY and subject to DEY quality standards and
approvals.
2.2 Access to Information. Subject to the terms and conditions
of this
Agreement, each Party shall cooperate in good faith to provide
access to and
reasonable assistance with its Proprietary Information and other
significant
information of which it becomes aware that may be legally
disclosed and that it
reasonably believes may be required for the other to perform its
obligations
hereunder.
ARTICLE 3
GOVERNANCE
3.1 Alliance Manager. DEY and CRTX each shall appoint a person
(an "Alliance
Manager") to oversee compliance with this Agreement. The
Alliance Managers shall
also be the primary contact between the Parties with respect to
the reporting of
each Party's activities and performance. Each Party's initial
Alliance Manager
is set forth on Schedule 3.1 attached hereto. Each Party shall
notify the other
in writing as soon as practicable upon changing its Alliance
Manager
appointment.
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ARTICLE 4
PROMOTION AND MARKETING ACTIVITIES / PARTY OBLIGATIONS / IP/
TRAINING
4.1 General. Subject to the restrictions of Article 2.1, each
Party will
diligently Promote the Product in the Territory during the Term
and as of the
Detail Commencement Date, subject to the terms and conditions of
this Agreement
and in accordance with its business, legal, medical and
scientific judgment and
all Applicable Laws.
4.2 Sales Forces. During the Term and as of the Detail
Commencement Date, for
DEY and CRTX, respectively, each Party will provide, at its own
expense, a
professional, appropriately-trained sales force to support its
obligations under
this Agreement. The sales force of each Party shall remain under
the direct and
exclusive authority, supervision and control of that Party at
all times during
the Term. For purposes of this Agreement, all members of CRTX's
sales force
performing Details on the Product shall be employees of CRTX.
DEY shall not be
involved in the interviewing, selection or hiring or the
management or
supervision of CRTX's sales force. CRTX shall use Commercially
Reasonable
Efforts to ensure that the qualifications of its Sales
Representatives meet or
exceed the minimum criteria (including, without limitation, with
respect to
education and sales experience) required by CRTX as of the date
hereof with
respect to its Sales Representatives detailing products other
than the Product.
For purposes of this Agreement, all members of DEY's sales force
shall be
employees of DEY. CRTX shall not be involved in the
interviewing, selection or
hiring or the management or supervision of DEY's Sales
Representatives.
4.3 CRTX Obligations:
(1) During the Term and starting on the Detail Commencement
Date, CRTX, at its
expense, shall deliver to Detail Targets at least [**] primary
detail
equivalents ("PDEs") of Product Details in at least the
secondary position per
full calendar month after the Detail Commencement Date. The
frequency of CRTX's
Product Details per full calendar month will be determined by
CRTX. A Call in
the tertiary position shall not count toward CRTX's PDE
obligations unless the
parties agree otherwise in writing. CRTX will deliver Product
Details to at
least [**] Detail Targets per Calendar Quarter.
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(2) For all Product Details in Subsection 4.3 (1), only details
to Detail
Targets (as defined in Section 1.22 of this Agreement) shall be
counted towards
CRTX's PDE requirements.
(3) If and to the extent that CRTX decides to acquire Samples,
CRTX, [**], may
acquire from DEY supplies of Samples for DEY-approved sampling
activities by
CRTX's Sales Representatives at DEY's [**] of such Samples;
provided, however,
CRTX shall have no minimum sampling obligations to meet and CRTX
may elect not
to procure or provide Samples. CRTX has the option to perform
Product sampling
during the Calls. CRTX also is responsible for the proper
storage, handling, and
distribution of any Samples that CRTX orders from DEY. If CRTX
notifies DEY that
CRTX intends to perform Product sampling, DEY shall assume costs
of shipment of
Samples to one location designated by CRTX.
(4) CRTX, [**], shall acquire from DEY supplies of Promotional
Materials for use
by CRTX at DEY's [**] of such Promotional Materials; provided,
however, CRTX
shall have no obligation to use any particular Promotional
Materials except
those core Promotional Materials mutually agreed to between the
Parties.
(5) CRTX's incentive compensation plan for its Sales
Representatives detailing
the Product shall reflect the secondary position of the Product,
with the goal
of ensuring quality secondary product Details. The plan shall be
determined by
CRTX, but CRTX shall consult with DEY and consider suggestions
from DEY.
Compensation of such CRTX Sales Representatives shall align with
such plan.
(6) During the Term, CRTX shall not, directly or indirectly,
manufacture,
Detail, sell, market or promote in the Territory any product
(except for Product
during the Term) containing formoterol, including but not
limited to
arformoterol, and any salt, enantiomer, and/or derivative
thereof ("FAPI") as
one of the active pharmaceutical ingredients if any approved
indication of the
product is the same as any approved indication of the Product as
of the date
upon which CRTX intends to begin to, directly or indirectly,
manufacture,
Detail, sell, market or promote such product in the Territory
(the "Limited
Product"). If this Agreement expires or is terminated for any
reason, CRTX shall
not, directly or indirectly, manufacture, Detail, sell, market
or Promote
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any Limited Product in the Territory until one (1) year after
such expiration or
termination ("Post-Term Non-Compete Period"); provided, however,
this Post-Term
Non-Compete Period shall not apply and shall be void in the
event CRTX signs a
definitive agreement to be acquired by or merged with a Third
Party that
markets, manufacturers, sells, details or promotes a Limited
Product in the
Territory (the "Transaction"); and, instead, the following
provision shall apply
(the "Post-Term Non-Promote Period"): CRTX agrees that until the
date that is
180 days after the date of the expiration or termination of this
Agreement or
the date that is 180 days after the closing date of the
Transaction, whichever
occurs sooner, CRTX shall not allow any CRTX Covered Sales
Representative (as
defined below) to Detail, market or promote any Limited Product
in the Territory
to any office-based physician or other office-based health care
professional.
For purposes of this Section 4.3(6), a "CRTX Covered Sales
Representatives"
shall mean a Sales Representative employed by CRTX (or by its
acquirer or by a
subsidiary of its acquirer) who, within [**] before the date of
the expiration
or termination of this Agreement or the closing date of the
Transaction,
whichever occurs sooner, either (i) has been trained on the
Product or (ii) has
detailed the Product. The Post-Term Non-Promote Period shall not
require CRTX or
CRTX's acquirer to take any particular actions with any Sales
Representative who
does not satisfy the CRTX Covered Sales Representative
definition. This Section
4.3(6) also shall apply with respect to any combination product
containing both
FAPI and Zileuton as active ingredients. Notwithstanding the
foregoing, if (i)
this Agreement is terminated by CRTX pursuant to a DEY breach
under Section
12.2(2) or (ii) a Third Party AB-rated generic product to the
Product enters the
Territory during this Post-Termination Non-Compete Period, both
the
Post-Termination Non-Compete Period and the Post-Term
Non-Promote Period in this
Section 4.3(6) shall be void; provided, however, DEY and CRTX
shall continue to
abide by the provisions of Section 9 of this Agreement after
such expiration or
termination.
4.4 DEY Obligations:
(1) DEY is responsible for all Promotion Expenses and the
development and
implementation of Promotion Plans for the Product during the
Term. During the
Term, DEY is also solely responsible for DEY's sales force
expenses, cost of
Samples distributed by DEY's sales force and salaries for its
own employees
performing marketing functions, all of which shall be separate
from and in
addition to Promotion Expenses (and also includes detail
aids,
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promotional items, market research), and such shall be DEY's
responsibility and
not CRTX's responsibility. CRTX's sales force expenses, printing
cost of the
Promotional Materials used by CRTX, and the cost of Samples, if
any, distributed
by CRTX's sales force shall also be separate from and in
addition to the Product
Promotion Expenses and such be CRTX's responsibility and not
DEY's
responsibility.
(2) DEY, at its sole expense, will be responsible for obtaining
and maintaining
all applicable FDA regulatory approvals for the Product and for
approving and
submitting to FDA all Promotional Materials to be used in the
Territory, all as
according to Applicable Laws.
(3) DEY also will be solely responsible for the following:
a) Setting the pricing of the Product covered under this
Agreement and
approving Rebates and Discounts to wholesalers, managed care
organizations, or Federal, state or local government programs
(e.g.,
Medicare or Medicaid) related to the Product;
b) Developing and implementing managed care strategies;
c) Maintaining its exclusive rights to the Product in the
Territory,
other than those granted to CRTX herein;
d) the management and costs of any future clinical research and
trials
that DEY elects to conduct, if any, relating to the Product or
any
changes in its labeling;
e) Using Commercially Reasonable Efforts to supply and
distribute
GMP-compliant Product in accordance with the Product's
respective
specifications; and,
f) Using Commercially Reasonable Efforts to supply and ship only
to a
single site designated by CRTX sufficient quantities of
GMP-compliant
commercial Samples for CRTX's sampling program, as approved by
DEY,
which Samples shall be provided at DEY's [**] during the
Term;
provided, DEY shall pay for all shipping charges of such Samples
to
the site designated by CRTX.
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(4) DEY shall use Commercially Reasonable Efforts to provide
CRTX with
Promotional Materials and training materials for the performance
and supervision
of Calls by a reasonable date prior to the Detail Commencement
Date projected by
CRTX. In the case of training materials, a reasonable date shall
be the later of
August 1, 2007, or within 15 days after CRTX notifies DEY in
writing of the
projected Detail Commencement Date. In the case of Promotional
Materials, a
reasonable date shall be the later of September 3, 2007, or
within 30 days after
CRTX notifies DEY in writing of the projected Detail
Commencement Date. The
Parties agree that timely delivery of such materials is
necessary in order for
CRTX to meet the agreed upon Detail Commencement Date. Such
Promotional
Materials shall be provided to CRTX by DEY at DEY's [**]. DEY
shall be solely
responsible for the preparation, content and method of
distribution of the
Promotional Materials to one location designated by CRTX. CRTX's
Sales
Representatives shall use only the Promotional Materials
provided by DEY in
conducting Calls hereunder and shall not develop, create, or use
any other
promotional material or literature, or any other materials of
any kind in
connection with the Detailing of the Product. When depleted by
CRTX, DEY will
coordinate with CRTX to replenish on a timely basis CRTX's
supply of Promotional
Materials, which also shall be sent to one location designated
by CRTX. DEY
shall notify CRTX promptly of any inaccuracy or incompleteness
of the
Promotional Materials or labeling. Upon such notice, CRTX will
advise its Sales
Representatives to cease the use of all of the Promotional
Materials or labeling
(or any portion thereof) so identified by DEY and will either
destroy or return
such Promotional Materials or labeling to DEY, at DEY's
instruction and expense.
DEY shall furnish CRTX with corrected Promotional Materials or
labeling as soon
as practicable thereafter (such corrected Promotional Materials
to be provided
to CRTX at no cost to the extent of materials previously
purchased are
unusable). DEY shall be responsible for all interactions with
the FDA regarding
approval and /or submission of all Promotional Materials.
(5) DEY shall use Commercially Reasonable Efforts to provide
support to CRTX to
enable CRTX to begin Promoting the Product by Commercial Launch
Date.
4.5 Intellectual Property. Each of CRTX and DEY shall retain
their respective
intellectual property rights, including without limitation, all
patents
(including the DEY Patents) and patent applications, copyrights
and trademarks
(including the DEY Trademarks), owned by such Party as of the
Effective Date or
otherwise arising during the Term and relating to such
Party's
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respective existing programs and materials in all formats
(print, video, audio,
digital, computer, etc.) regarding sales training, patient
education and disease
management programs owned or controlled by such Party at the
time such materials
are shared with the other Party, as well as any modifications of
such programs
each may develop in the future which are not specific to the
Product. Except as
otherwise prohibited by Applicable Laws and as otherwise set
forth herein, all
Promotional Materials used during the Term, including journal
advertising and
sales aids (excluding packaging and FDA approved Product
Labeling) may display
the names and logos of CRTX and DEY. Except as otherwise
prohibited by
Applicable Laws, and to the extent reasonably practicable, all
Promotional
Materials will indicate that the applicable Product is
manufactured and sold by
DEY, promoted by DEY and CRTX, and that the CRTX Trademarks are
owned by CRTX
and that the DEY Trademarks are owned by DEY. Notwithstanding
the foregoing, the
Parties acknowledge and agree that, to the extent DEY may have
existing stock of
Promotional Materials as of Detail Commencement Date, DEY shall
be permitted to
utilize such stock and to provide such stock to CRTX for use in
connection with
its promotional efforts prior to the development and
distribution of new
Promotional Materials displaying the names and logos of both
CRTX and DEY.
During the Term, all applicable logos, subject to compliance
with Applicable
Laws, shall be prominently displayed in accordance with each
Party's
specifications and be of similar size to each other on all such
materials. Each
Party hereby consents to such use of its name and logo, provided
that the other
Party adheres to the agreed upon format and language and,
provided further, that
neither Party will acquire any ownership rights in the other
Party's name or
logo, or any rights to use the other Party's name or logo beyond
those set forth
in this Section 4.5. After expiration of the Term or after the
termination of
this Agreement, neither Party will include any of the other
Party's names or
logos on any Promotional Materials, except as required by
Applicable Laws. If
either party's corporate name or logo should change from what it
is at Effective
Date of this Agreement, such Party shall be responsible and
reimburse the other
party for all additional expenses in connection with procuring
additional stock
of Promotion Materials as a result of such name or logo
change.
4.6 Training.
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(1) Each Party shall have the responsibility for training its
Sales
Representatives with respect to the Promotion of the Product in
the Territory,
and each Party will be solely responsible for all costs
associated with training
its respective Sales Representatives. During the Term, DEY shall
provide CRTX
with such assistance as is reasonably requested by CRTX, and as
mutually agreed
to in connection with the training programs to help ensure that
the training of
CRTX's Sales Representatives will be consistent with the
training provided to
DEY's Sales Representatives regarding the sales of the Product
in the Territory.
(2) During the Term, in order for CRTX to meet the projected
Detail Commencement
Date, DEY shall provide sufficient quantities of training
materials relating to
the Product, including an up-to-date programmed learning unit
for "at home"
study. DEY shall supply such materials to one CRTX-designated
location by later
of [**], or [**] days after its receipt of written notice of the
projected
Detail Commencement Date from CRTX. DEY shall be responsible for
the cost of
developing and CRTX shall be responsible for the cost of
duplicating such
materials.
(3) All expenses during the Term that are incurred by either
Party and
associated with any launch meeting or any training meetings for
the Product for
such Party's sales force shall be the responsibility of the
Party incurring such
cost. Promptly after the date that CRTX has confirmed the
projected Detail
Commencement Date to DEY, CRTX and DEY shall agree on a mutually
convenient
schedule that will enable the training of the CRTX sales force
in sufficient
time to meet the projected Detail Commencement Date.
(4) In addition to the training referred to above, during the
Term, each Party
shall conduct separate training programs for their respective
sales force with
respect to the Medicare and Medicaid Anti-Kickback Statute, as
set forth at 42
U.S.C. Section 1320(a)-7b(b) and the acts prohibited thereunder,
PDMA
regulations, and all other applicable guidances relating to
promotion of
Product, including, without imitation, the PhRMA Code on
Interactions with
Healthcare Professionals. Upon completion of such additional
training, each
sales force member shall be required to sign a certificate
acknowledging their
receipt of such training and certifying and acknowledging their
attendance at
the training.
4.7 Other Marketing and Promotion Services.
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(1) DEY or its Third Party contractor shall provide reasonable
order entry,
customer service, reimbursement management, medical affairs
(including reports
for all Adverse Events as set forth herein at Article 6),
medical or drug
information, warehousing, physical distribution, invoicing,
credit and
collections (including maintaining and enforcing the credit
policy applicable to
the Product) production forecasting and other related facilities
and services
necessary or desirable for the manufacturing and supply,
distribution,
marketing, Promotion and sales of the Product under this
Agreement. Such
services shall include contract administration, including
handling wholesaler
chargebacks, managed care contracts, federal and state
government contracts,
rebate contracts, long-term care contracts, performance-based
contracts, and
hospital purchasing contracts. DEY shall book all sales and be
exclusively
responsible for accepting and filling purchase orders for
Product and for
processing billing and returns with respect to the Product.
(2) DEY will provide CRTX with reasonable access (at DEY's
expense for any
additional work that DEY may request) to all medical education
and medical or
drug information regarding the Product and FAQs, with respect to
the Promotion
of the Product.
(3) In addition to any other reports required by this Agreement,
DEY shall
provide to CRTX at no cost to CRTX:
(i) on a monthly basis, within [**] days after the end of each
month
beginning or ending during the Term, reports of (A) WAC Price;
(B) Rebates
and Discounts; and (C) Net Retail Average Selling Price for the
immediately
preceding month;
(ii) on a monthly basis, the number of Retail Units; after DEY
has received
the data from Wolters Kluwer Health or a similar Third
Party;
(iii) on a monthly basis, complete and accurate records of the
actual
number of Sales Representatives in DEY's sales force who, at the
end of
each calendar month, are actively Detailing the Product to
office-based
physicians and other office-based health care professionals in
the
Territory); and,
(iv) such other reports as may be reasonably requested by CRTX
in
connection with the performance of the Parties' obligations
hereunder.
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4.8 Covenants of the Parties.
(1) CRTX covenants that, during the Term, the CRTX sales force
shall (i) limit
its claims of efficacy and safety for the Product to those that
are consistent
with approved promotional claims and FDA-approved prescribing
information for
the Product in the Territory; (ii) not add, delete or modify
claims of efficacy
and safety in the Promotion of the Product from those claims of
efficacy and
safety that are consistent with the FDA-approved prescribing
information; (iii)
use the Promotional Materials in accordance with this Agreement
and Applicable
Laws; (iv) Promote the Product in accordance with Applicable
Laws; and, (v)
comply with the CRTX code of business conduct and Comprehensive
Compliance
Program.
(2) DEY covenants that, during the Term, the DEY sales force
shall (i) limit its
claims of efficacy and safety for the Product in the Territory
to those that are
consistent with approved promotional claims and FDA-approved
prescribing
information for the Product; (ii) not add, delete or modify
claims of efficacy
and safety in the Promotion of the Product under this Agreement
from those
claims of efficacy and safety that are consistent with the
FDA-approved
prescribing information; (iii) use the Promotional Materials in
accordance with
this Agreement and Applicable Laws; and (iv) Promote the Product
in accordance
with Applicable Laws; and, (v) comply with the DEY Code of
Conduct and
compliance program.
ARTICLE 5
FINANCIAL TERMS / PAYMENTS / STATEMENTS
5.1 During the Term and after the Detail Commencement Date, DEY
will pay CRTX on
a Calendar Quarter basis a Co-Promotion Fee, which shall be
calculated and paid
as follows:
(1) No Co-Promotion fee will be paid with respect to Retail
Units sold in
any Calendar Quarter if the number of Retail Units of Product
sold in
such Calendar Quarter is less than the QRBU for such Calendar
Quarter.
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(2) TIER 1: With respect to the number of Retail Units sold
during each
Calendar Quarter in excess of the QRBU, but not more than [**]
Retail
Units above the QRBU for such Calendar Quarter (the "Applicable
Tier 1
Retail Units"), DEY shall pay to CRTX a Co-Promotion Fee for
that
Calendar Quarter calculated according to the following
formula:
(Applicable Tier 1 Retail Units) x (Net Retail Average
Selling
Price for such Calendar Quarter) x [**]%.
(3) TIER 2: With respect to the number of Retail Units sold
during each
Calendar Quarter in excess of those Retail Units that are
subject to a
Co-Promotion fee under Section 5.1(2) above during such
Calendar
Quarter (i.e., in excess of the QRBU for such Calendar Quarter,
plus
[**]) (the "Applicable Tier 2 Retail Units"), DEY shall pay to
CRTX a
Co-Promotion Fee for that Calendar Quarter calculated according
to the
following formula:
(Applicable Tier 2 Retail Units) x (Net Retail Average
Selling
Price for such Calendar Quarter) x
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