CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
CONFIDENTIAL
TREATMENT REQUESTED. CONFIDENTIAL PORTIONS
OF
THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED
WITH THE COMMISSION.
CONFIDENTIAL
TREATMENT
This
CO-PROMOTION AGREEMENT (“Agreement”) dated as of April 3, 2006 (the “Effective
Date”), by and between TEAMM Pharmaceuticals, Inc. a Florida corporation with
offices located at 0000 Xxxxxx Xxxxxx Xxxxxxx, Xxxxxxxxxxx, XX (“TEAMM”) and
Exaeris, Inc. a Delaware corporation with offices located at 000 Xxxxxx Xx,
Xxxxx, XX 00000 (“Exaeris”)
WITNESSETH:
WHEREAS,
TEAMM
markets and
promotes the pharmaceutical product MD Turbo™ (including any improvements,
modifications, revisions and anticipated related products, collectively the
“Product”) to a physician audience which focuses on Primary Care and Respiratory
specialties.
WHEREAS, TEAMM
desires to expand the detailing and
promotion of the Product to additional physician audiences;
WHEREAS,
Exaeris
desires to detail and promote the Product to prescribers
including * * * (the “Exaeris Prescribers”) other than
the
physicians called on by TEAMM
(the “TEAMM Prescribers”).
NOW,
THEREFORE,
for and
in consideration of the mutual covenants and promises hereinafter contained,
the
parties hereto do intend to be legally bound hereby, do hereby agree as
follows:
ARTICLE
1
DEFINITIONS
The
following terms shall, for purposes of this Agreement, have the meanings
designated to them under this Article unless otherwise specifically
indicated.
| 1.1 |
“Act”
shall mean the Federal Food, Drug and Cosmetic Act, as amended, and
regulations promulgated thereunder.
|
| 1.2 |
“Affiliates”
shall means with respect to a Party (a) corporation or business entity
of
which fifty percent (50%) or more of the securities or other ownership
interests representing the equity, the voting stock, or general
partnership interest are owned, controlled or held, directly or
indirectly, by the Party; or (b) any corporation or business entity
which,
directly or indirectly, owns, controls or holds fifty percent (50%)
or
more of the securities or other ownership interests representing
the
equity, the voting stock or, if applicable, the general partnership
interest, of the Party; or (c) any corporation or business entity
of which
fifty percent (50%) or more of the securities or other ownership
interests
representing the equity, the voting stock or general partnership
interest
are owned, controlled or held, directly or indirectly, by a corporation
or
business entity.
|
CONFIDENTIAL
TREATMENT
| 1.3 |
“Co-Promotion
Date”
is the date the TEAMM and Exaeris sales force begin detailing the
Product.
|
| 1.4 |
“Commercial Oversight
Committee”
shall be a committee consisting of one representative appointed by
TEAMM
and one representative appointed by Exaeris. The Oversight Marketing
Committee shall perform the functions delegated to it
herein.
|
| 1.5 |
“Contract
Year”
shall mean a period of twelve (12) successive calendar months during
the
term of this Agreement; provided, however, the parties agree that
the
first Contract Year shall commence on the Launch Date and extend
for 12
consecutive months.
|
| 1.6 |
“Detail”
or “Detailing”
shall mean, with respect to the Product, face-to-face activity undertaken
by a Sales Representative during a sales call on licensed physicians
to
the “TEAMM Prescribers” or “Exaeris Prescribers” , in such physicians’
offices or hospitals (excluding national conventions and other forms
of
communication not involving face-to-face contact by such sales
representative), of describing the indicated uses, safety, effectiveness,
contraindications, side effects, warnings and other relevant
characteristics of the Product, in a fair and balanced manner consistent
with the requirements of the Act, and when samples of the Product
are
provided to such licensed physicians, such action shall be evidenced
by a
sample form signed by the licensed physician, all in an effort to
increase
physician prescribing preferences of the Product for its indicated
uses.
|
| 1.7 |
“Exaeris
Percentage”
is that percentage calculated by taking the number of prescriptions
that
are credited to the Exaeris Prescribers divided by the total number
of
prescriptions written for the Product by both Exaeris Prescribers
and
TEAMM Prescribers in the same measurement period.
|
| 1.8 |
“Exaeris
Prescribers”
shall mean those physicians that TEAMM and Exaeris have agreed will
be
Detailed by Exaeris Sales Representatives and will be used for determining
Exaeris Percentage of prescriptions for purposes of compensation.
|
| 1.9 |
“First
Detailing Year”
shall mean a period commencing on the Co-Promotion Date and ending
approximately one year thereafter on the first day of the first full
calendar month following the Co-Promotion Date. The Second through
Last
Detailing Years shall be successive one year periods which commence
on the
annual anniversary date of the first day of the first full calendar
month
following the Co-Promotion Date.
|
| 1.10 |
“FDA”
shall mean the United States Food and Drug Administration, or any
successor entity thereto.
|
CONFIDENTIAL
TREATMENT
2
| 1.11 |
“Invoiced
Sales”
shall mean, * * *
|
| 1.12 |
“Launch”
for purposes of this Agreement, shall mean the initial date that
Product
is shipped and invoiced to TEAMM’s customers.
|
| 1.13 |
“Marketing
Plan”
shall mean for the Product, the marketing objectives, strategies
and
tactics and non-binding financial projections, including but not
limited
to, unit and dollar sales forecasts, advertising and promotion budgets,
projections for sample quantities and cycle ship dates for such sample
quantities, target audience and amendments from time to time thereto,
developed and written by TEAMM.
|
| 1.14 |
“Minimums”
shall mean the minimum amount of measurements listed in Article 10.2
(including but not limited to number of Sales Representatives, number
of
details, number of physicians detailed, percent of prescriptions
generated) to meet contract obligations.
|
| 1.15 |
“Net
Quarter Sales”
of Product or “Net Year Sales” shall be * *
*.
|
| 1.16 |
“Net
Sales”
shall mean the price charged by TEAMM for the Product in bona fide
arm's
length sales to unaffiliated parties in the United States after deduction
of the following items: * * *
|
Such
amounts shall be determined from TEAMM’s books and records which TEAMM shall
maintain in accordance with generally accepted accounting principles (GAAP)
consistently applied.
| 1.17 |
“Net,
Net Sales”
shall mean * * *
|
| 1.18 |
“Person”
shall mean a natural person, a corporation, a partnership, a limited
liability company, a trust, a joint venture, any government authority
or
any other entity or organization.
|
| 1.19 |
“Prescriber
Data”
shall mean the Wolters Kluwer (previously known as NDC) Prescriber
data
publication compiled and published by Wolters Kluwer containing
prescription data by prescribing
physician.
|
| 1.20 |
“Primary
Detail”
shall mean a detail on a product that is given as first product message
and greatest emphasis in a sales
call
|
| 1.21 |
“Product”
shall mean MD Turbo in finished package form marketed, distributed
and
sold by TEAMM as of the Effective Date
|
| 1.22 |
“Product
Contribution/Co-Promotion Payment”
shall mean Net, Net Sales less a fixed distribution cost of *** and
a
fixed administrative cost of ***, both applied against invoiced sales.
|
CONFIDENTIAL
TREATMENT
3
| 1.23 |
“Product
Development Agreement”
shall mean the Product Development Agreement dated January 24, 2003
and as
amended, between TEAMM Pharmaceuticals, Inc. and Respirics, Inc.
which
provides for the license to TEAMM Pharmaceuticals to market MD Turbo.
|
| 1.24 |
“Product
Labeling”
shall mean (a) the full prescribing information for the Product and
(b)
all labels and other written, printed or graphic matter upon any
container, wrapper or any package insert or outsert with or for the
Product.
|
| 1.25 |
“Promote”,
“Promotion”, “Promoting” or “Promotional”
shall mean, with respect to the Product, those activities and obligations
other than Detailing, to encourage sales of Product including but
not
limited to journal advertising, direct mail programs, convention
exhibits
and other forms of advertising and promotion specified in the Marketing
Plan.
|
| 1.26 |
“Product
Promotional Materials”
shall mean all sales representative training materials and all other
printed, graphic, audio and video matter including but not limited
to
sales aids, study reprints, journal advertisements, direct mail and
sales
reminder aids (e.g.
scratch
pads, pens, and other such items) intended for use or used by
representatives of either Exaeris or TEAMM in connection with Promotion
or
Detailing of the Product.
|
| 1.27 |
“Quarter”
shall mean a period of three (3) successive calendar months during
the
term of this Agreement. The first Contract Quarter shall commence
upon the
first day of the first quarter after the launch of the “product” (i.e.
January, April, July or September). For purposes of this Agreement,
should
the Co-Promotion Date not fall on the first day of the quarter, the
beginning period may include more than three months.
|
CONFIDENTIAL
TREATMENT
4
| 1.28 |
“Quarter
Sales” of Product shall
mean the amount invoiced and recognized for the Products in the Territory
during the respective period. For purposes of this agreement, product
shipped in the last three days of a quarter are recognized in the
following quarter.
|
| 1.29 |
“Respirics”
(Respirics, Inc.)
shall mean the developer and holder of the trademark(s) and patents
for MD
Turbo.
|
| 1.30 |
“Sales
Representative(s)”
shall mean an individual(s) in a sales function whose primary
responsibility is to present the Product and who will be engaged
in
Detailing of the Product to health care professionals
hereunder.
|
| 1.31 |
“Sample(s)”
or “Sampling Program”
shall mean a MD Turbo or a MD Turbo Kit (includes a MD Turbo, mouth
pieces
and placebo inhaler) given to a healthcare professional for their
use in
demonstrating the device to patients.
|
| 1.32 |
“Second
Detail Position”
shall mean a detail on a product that is given as second product
message
and consist of but not limited to, a full product detail on features,
benefits and positioning statement.
|
| 1.33 |
“Specifications”
shall mean the specification for manufacturing and testing the Product
as
set forth in the approved 510(k)and any supplement or amendments
thereto.
|
| 1.34 |
“TEAMM
Prescribers”
shall mean those physicians detailed by TEAMM Sales Representatives
as
listed on Schedule A attached hereto and will be used for determining
TEAMM Percentage of prescriptions. Schedule A may be updated from
time to
time by written notice from TEAMM to Exaeris.
|
| 1.35 |
“Territory”
shall mean the United States of America, its territories and possessions
herein.
|
| 1.36 |
“Trademarks”
shall mean those trademarks and trade names, whether or not registered
in
the United States, trade dress and packaging which (a) are owned
by either
TEAMM or Respirics and are set forth in Exhibit 2 attached hereto
and (b)
are applied to or used with the Product or any Product Promotional
materials.
|
ARTICLE
2
APPOINTMENT
| 2.1 |
TEAMM
hereby enters into a non-exclusive co-promotion agreement and appoints
Exaeris as its co-promotion marketing partner for the promotion of
the
Product in the United States and Exaeris hereby accepts such appointment
to co-promote the Product in the United States in accordance with
the
terms and conditions hereof. Notwithstanding the foregoing, TEAMM
shall
retain the right to also promote the Product itself in the United
States.
|
CONFIDENTIAL
TREATMENT
5
| 2.2 |
The
Product will be sold only under TEAMM’s NDC number and therefore all sales
will be recorded on TEAMM’s books and TEAMM will assume all responsibility
for filing all reports required for each prescription NDC.
|
| 2.3 |
Subject
to the provisions of and during the term of this Agreement, Exaeris
shall
use reasonable commercial efforts consistent with accepted business
practices and legal requirements to deploy its Sales Representatives
to
Detail the Product in the United States in such a manner and with
such
expedition as Exaeris itself would have adopted in Detailing a
pharmaceutical product of its own taking into account the fact that
TEAMM’s Sales Representatives will be Detailing and Promoting the Product
in conjunction with Exaeris Sales Representatives and under the terms
of
this Agreement.
|
| 2.4 |
TEAMM
shall have the final authority on all prices and pricing strategies
relating to the Product. TEAMM agrees to discuss with Exaeris, any
proposed changes to pricing or pricing strategies prior to
implementation.
|
| 2.5 |
TEAMM
reserves the right to enter into one or more co-promotion agreement(s)
that would expand or supplement the geographic or prescriber base
being
Detailed on the Product, whether to include territories or prescribers
not
currently Detailed on the Product or to expand or intensify Detailing
coverage. The planned addition of other co-promotion partners or
expansion
of territories will be discussed in advance with Exaeris to determine
whether Exaeris has both the desire and the resources to assume
responsibility for any expansion territory or expansion prescriber
base
other than that expansion by TEAMM’s sales force or TEAMM Prescriber List.
In any event, the addition of any such expansion territory or prescriber
base shall be by and in accordance with written agreement of TEAMM
and
Exaeris.
|
ARTICLE
3
SERVICES
PROVIDED BY TEAMM
| 3.1 |
TEAMM
shall be responsible for all Product marketing and Product distribution,
and shall carry out such responsibilities in accordance with the
terms and
conditions of this Agreement.
|
| 3.2 |
TEAMM
shall at its sole expense (except as otherwise expressly provided
herein)
have responsibility for performing the activities set forth below:
|
|
(a)
|
Contract
for the manufacture of the Product and Samples, or arrange through
Respirics for a third-party to contract manufacture the Product and
Samples, in accordance with its established procedures in trade and
Sample
packs.
|
|
(b)
|
Maintain
trade pack inventories of Product in accordance with inventory management
systems TEAMM uses for other products of similar status and exposure
in
the marketplace.
|
CONFIDENTIAL
TREATMENT
6
|
(c)
|
Communicate
with the FDA in accordance with the Act for all Adverse Drug Experience
Reports relating to Product.
|
|
(d)
|
Distribute
the Product pursuant to orders received from TEAMM’s wholesaler customers,
its other direct customers or such other customers as may be mutually
agreed upon by the parties hereto, in accordance with TEAMM’s normal
business practices.
|
|
(e)
|
Invoice
customers, collect payments, administer cash discounts for prompt
payment
and carry accounts receivable for the Product sold to TEAMM’s wholesaler
customers, its other direct customers or such other customers as
may be
mutually agreed upon by the parties hereto, all in accordance with
TEAMM’s
normal business practices.
|
|
(f)
|
Process
required payment of rebates to government or quasi-government agencies
and
hospital or other group purchasing
organizations.
|
|
(g)
|
Prepare
and submit to the Commercial Oversight Committee for its review all
Marketing Plans and proposed appropriate marketing activities, expected
to
include agency management, convention management, marketing and sales
promotion.
|
|
(h)
|
Sales
coverage and promotion to National Accounts (wholesalers and chains),
Managed Care Organizations, and Federal and State Reimbursement
plans.
|
| 3.3 |
TEAMM
shall provide financial information to Exaeris regarding sales as
reported
by the Prescriber Data and costs relating to the Product. This financial
information will also include Invoiced Sales, wholesaler inventory
levels,
customer buying patterns and managed care formulary status.
|
| 3.4 |
TEAMM
will provide training assistance by making its sales trainer available
to
initial training at launch of Exaeris’ Sales Representatives at TEAMM’s
expense. Exaeris will be responsible for all other training costs
for
their sales force (i.e.,
meetings,
travel, etc.).
|
| 3.5 |
TEAMM
will provide Exaeris with developed Product Promotional Materials
and
Samples at quantities requested by Exaeris, at direct pass-through
costs
|
| 3.6 |
TEAMM
will contract for and purchase, at its sole cost and expense, Prescriber
Data as outlined in the agreement.
|
CONFIDENTIAL
TREATMENT
7
ARTICLE
4
SERVICES
PROVIDED BY EXAERIS
| 4.1 |
Exaeris
will position the Product in no lower than a Second Position Detail
to the
Exaeris Prescribers, as documented by agreement of the parties and
approved by TEAMM, throughout the term of the Agreement unless otherwise
approved by both companies.
|
| 4.2 |
Exaeris
will provide updates of “Exaeris Prescribers” to TEAMM in an agreed upon
format, with inclusion of necessary information (i.e. Medical Education
(ME) number, etc) in an Excel spreadsheet as shown in Exhibit 3.
TEAMM and
Exaeris will share each others prescribers lists. Updates shall be
sent by
each Party to the other on a quarterly basis not later than 21 days
in
advance of the beginning of the quarter. TEAMM and Exaeris will review
the
Prescriber lists for a physician[s] that may appear on each company’s
Prescriber lists and agree on which Prescriber list (or possibly
both) the
physician[s] will be credited.
|
| 4.3 |
Exaeris
will provide TEAMM with an annual forecast for Sample and Promotion
Material requirements, which forecast shall be in accordance with
the
Marketing Plan and subject to review and approval by Commercial Oversight
Committee. TEAMM will ship the samples to the location, compliant
with
PDMA guidelines, that Exaeris specifies at mutually agreed upon times
at
Exaeris costs.
|
| 4.4 |
Exaeris
will bear all sales force costs for Exaeris sales force including
but not
limited to salaries, expenses, benefits, company vehicles, and
administrative costs. TEAMM will bear all sales force costs for TEAMM
sales force including but not limited to salaries, expenses, benefits,
company vehicles, and administrative
costs.
|
| 4.5 |
Exaeris
will provide a bonus incentive on the product sales to the sales
force
customary to Exaeris’ current incentive plan and in line with the plan of
action (POA).
|
| 4.6 |
Exaeris
will have regularly scheduled POA and sales meetings to communicate
promotional strategy for the respective time period with input from
TEAMM
as needed.
|
| 4.7 |
In
the unlikely event of a recall, Exaeris will cooperate with TEAMM
to
effect a cost-efficient recall to be compliant with any and all regulatory
requirements and least disruptive to the business.
|
| 4.8 |
Both
during the term of this Agreement and after termination, each Party
shall
promptly notify the other of any Product complaint, including but
not
limited to any Adverse Drug Experience associated with the Product
received by such Party. TEAMM shall investigate and handle all Adverse
Drug Experiences associated with the Product, including those reported
to
TEAMM by Exaeris.
|
CONFIDENTIAL
TREATMENT
8
| 4.9 |
If
Exaeris receives orders for the Product, Exaeris shall make all reasonable
commercial efforts to forward such orders to TEAMM as soon as
practicable.
|
| 4.10 |
Exaeris
shall allow for and support any marketing support programs including
but
not limited to “lunch and learn” programs, local and national conventions
that would be compensatory to their spend on other Exaeris products
and
the product contribution.
|
| 4.11 |
Exaeris
will provide support of the Product at appropriate conventions and
with
Key Opinion Leader (KOL) development to the mutual benefit of Exaeris
and
TEAMM. This support will include providing Exaeris Sales Representative(s)
to participate with TEAMM at TEAMM’s convention booths and/or to provide
information and advertisements at Exaeris’ booth where appropriate and
commensurate with the specialty importance Exaeris to assist TEAMM
in KOL
development to the extent mutually agreed upon.
|
| 4.12 |
Exaeris’
Representative will make the agreed upon number of pharmacy calls
for
purposes of pharmacy stocking and product availability as outlined
in
Article 10.2 .
|
| 4.13 |
Exaeris
will maintain their own call activity tracking system and provide
periodic
reports of call activity and Sample distribution to
TEAMM
|
| 4.14 |
Exaeris
will contribute input to the Marketing Plan, strategy and marketing
activities that are directed toward allergy and pulmonology
specialists
|
ARTICLE
5
MUTUAL
COVENANTS
| 5.1 |
Each
Party shall cause its Sales Representatives to Detail the Product
in the
United States in accordance with the Marketing Plan developed by
TEAMM and
agreed upon by the Commercial Oversight Committee. Each Party will
Promote
the Product using the same professional sales and marketing standards
as
it uses for its own products.
|
| 5.2 |
Each
Party’s Sales Representatives shall make all Details in accordance with
approved labeling. Sales Representatives shall distribute only the
designated Promotional Materials with respect to Product pursuant
to the
Marketing Plan. In the performance of its obligations hereunder,
each
Party shall, and shall cause its Sales Representatives to, comply
with all
applicable laws and regulations, including without limitation the
FDA and
the regulations promulgated
thereunder.
|
| 5.3 |
Each
Party will maintain and provide reports on sales calls, sample
accountability, sample reporting, physician feedback and competitive
information. Each Party will be responsible for submitting all necessary
documentation to the appropriate agency to satisfy any state and
federal
regulations on sample accountability and reporting for their respective
sales force and the samples shipped to it or their employees.
|
CONFIDENTIAL
TREATMENT
9
| 5.4 |
Each
Party will provide appropriate sales training (initial and ongoing)
for
their Sales Representatives necessary for Promotion of the Product
and
compliance with FDA regulations.
|
| 5.5 |
Each
Party will offer cooperation effort to coverage of Managed Care
Organizations and Federal and State Reimbursement plans to the mutual
benefit of both parties.
|
ARTICLE
6
TRAINING
| 6.1 |
During
the term of this Agreement, Exaeris will conduct initial and ongoing
training of this Product to their Sales Representatives. During the
term
of this Agreement, and at Exaeris’s option, TEAMM shall make available to
Exaeris, upon a schedule to be arranged by discussion among the parties,
to TEAMM sales training personnel who will assist Exaeris’ product and
sales management teams in connection with the Detailing of the Product
as
outlined in Article 3.4. During the term of this Agreement, TEAMM
shall
also provide Exaeris, without cost to Exaeris, with reasonable quantities
of training materials for the Product which have been created and
developed by TEAMM. Exaeris shall have the responsibility for, and
control
over, the manner in which it trains its Sales Representatives with
respect
to the Product, however the training shall be consistent with the
Marketing Strategies and compliant with FDA
regulations.
|
ARTICLE
7
COORDINATION
| 7.1 |
The
parties shall each appoint an authorized representative (“Coordinator”)
who shall have principle responsibility for inter-company communications
relating to the Product and to whom notices and correspondence relating
to
this Agreement will be directed. Each party will notify the other
as to
the name of the individual so appointed. Each party may replace its
Coordinator at any time, upon written notice to the other
party.
|
| 7.2 |
The
Coordinators shall establish a Commercial Oversight Committee (Committee)
within thirty (30) days following signing of the Agreement. This
Committee
will be directed by the Coordinators and consist of representatives
of
each party who will meet within sixty (60) days of the Effective
Date of
this Agreement to develop a co-promotion launch plan and thereafter
from
time to time, at mutually agreeable times and locations to discuss
and
coordinate the joint Detailing of the Product in the United States
and the
strategies and programs that should be developed to maximize the
sales of
the Product. Illustratively, the Committee shall (i) coordinate Exaeris’
launch of the Product in the United States and (ii) guide all continuing
joint detailing efforts with respect to the Product in the United
States.
TEAMM will have the final authority and responsibility, with the
cooperation and assistance of Exaeris, for developing detailing and
promotion strategies with respect to the
Product.
|
CONFIDENTIAL
TREATMENT
10
| 7.3 |
Exaeris
physician targets and call plans shall be agreed upon by Exaeris
and TEAMM
and will be the subject of the Exaeris Prescriber List on which
compensation will be based. TEAMM and Exaeris will exchange and compare
each party’s Prescriber List and Exaeris will make reasonable efforts to
call on high prescribing specialists (allergists, pulmonologists,
pediatricians and primary care) included in their geographic area
and not
called on by TEAMM’s Sales
Representatives.
|
| 7.4 |
From
time to time, but in no event less than once a year, the Commercial
Oversight Committee shall develop and formulate joint Marketing Plans
for
specified periods (collectively, the “Marketing Plan” ) which shall set
forth detailing, promotion, sampling and marketing strategies for
each
party relating to the Product. The provisions of the Marketing Plan
shall
be agreed to by the Coordinators, and if the Coordinators cannot
agree,
then the matters in dispute shall be referred to the Chief Operating
Officers of the parties. TEAMM, however, shall have the final
responsibility for, and control over, the development and content
of the
Marketing Plan. Unless otherwise agreed to by the parties, the initial
representatives from Exaeris and TEAMM will be * * * . Replacements
for
such individuals shall be of no less seniority than Director of Marketing.
The Committee, at it’s discretion, can include additional members from the
companies provided each company has equal representation.
|
| 7.5 |
Each
party shall bear its own costs associated with its participation
in the
Committee.
|
| 7.6 |
At
all times, Detailing, Promotional and Sampling activities will be
consistent with the requirements of federal
regulations.
|
| 7.7 |
During
the term of and subject to any other provision of this Agreement,
each
party will provide the other with all information relevant to the
detailing and promotion of the Product within a reasonable time after
such
information becomes known to the party, provided such information
is not
received under a secrecy obligation or is otherwise confidential
or
proprietary.
|
| 7.8 |
On
a quarterly basis the Commercial Oversight Committee (Committee)
shall
provide to the parties a written report on the activities and performance
of the co-promotion effort. The content and structure and presentation
format of this report will be determined by the Committee, however,
at a
minimum, the report will contain year to date sales performance,
variance
to budget, detailing activity, promotional spend vs. budget and a
TEAMM
prescription analysis on the following subsets of physicians: jointly
detailed physicians; TEAMM only and Exaeris
only.
|
| 7.9 |
Exaeris
agrees to Promote the Product in accordance with the provisions set
forth
in this Agreement and to follow the marketing strategies as outlined
in
the Marketing Plan, as it may be amended and supplemented by the
Committee
during the Term of this Agreement.
|
CONFIDENTIAL
TREATMENT
11
ARTICLE
8
PROMOTIONAL
MATERIALS
| 8.1 |
During
the term of this Agreement, TEAMM shall create and develop, with
the
assistance and cooperation of Exaeris, sales and Promotional Materials
relating to the Product for distribution to independent third parties.
TEAMM shall provide Exaeris with such materials, in amounts which
are
reasonable under the terms of the Marketing Plan. Other than with
the
advice and written consent of TEAMM, Exaeris shall not create or
develop
sales, promotional or other similar material relating to the Product
for
distribution to independent third parties, including members of the
medical and health professions. Exaeris shall reimburse TEAMM for
the
costs incurred by TEAMM to produce such all such sales and Promotional
Material supplied to Exaeris relating to the Product. The costs to
Exaeris
will be the direct pass through costs incurred by TEAMM for the printing
and shipping of sales and Promotional Materials in quantities requested
by
Exaeris. Exaeris will be responsible for agency costs only for material
that have been requested by Exaeris and for their sole use.
|
| 8.2 |
Exaeris
shall provide TEAMM with a list of Promotional Materials it agrees
to
utilize in the promotion of the Product and a schedule setting forth
Exaeris’ request for such materials and their delivery dates, all of which
shall be reasonable under then existing marketing conditions and
subject
to approval by TEAMM. TEAMM shall promptly inform Exaeris whether
it can
deliver such materials in accordance with such schedule. If TEAMM
cannot
meet the delivery schedule, Exaeris, at its option, shall have the
right
to have prepared, at its own expense, additional supplies of such
material, provided that such additional supplies conform in all respects
with the material produced by TEAMM. If requested by Exaeris, TEAMM
shall
use its best efforts to provide Exaeris, free of charge, with mechanical
and other items necessary to prepare such additional
supplies.
|
| 8.3 |
Exaeris
shall not be required to distribute any sales and Promotional Material
prepared after the date of this Agreement which (i) does not mention
the
Product, or (ii) includes a reference to another TEAMM pharmaceutical
product in addition to the Product. In no event shall TEAMM be required
to
distribute any material which contains a reference (i) to Exaeris
(other
than in connection with the Detailing of the Product in accordance
with
this Agreement) or (ii) any Exaeris pharmaceutical. Exaeris is not
obligated to utilize all Promotional Materials developed by
TEAMM.
|
| 8.4 |
TEAMM
and Exaeris shall comply with the terms of this Agreement and all
applicable laws and regulations, including, without limitation, the
FDA
and the regulations promulgated thereunder with respect to the sales
and
Promotional Materials described
herein.
|
CONFIDENTIAL
TREATMENT
12
ARTICLE
9
SAMPLING
| 9.1 |
To
achieve the objectives of this Agreement, both parties recognize
that it
is necessary to distribute the Product * * * as Samples to health
care
professionals on an ongoing basis (“Sampling Program”) and in a manner
consistent with the Marketing Plan. For any such Sampling Program,
the
Coordinators, from time to time, shall establish a reasonable sampling
strategy, setting forth a sampling period, the number of Samples
to be
distributed during such sampling period and the delivery schedule
for
Samples. TEAMM shall provide Exaeris with all of Exaeris’ reasonable
requirements for Samples of the Product as allotted under any such
Sampling Program. Exaeris shall reimburse TEAMM for the costs incurred
by
TEAMM to provide such Samples. TEAMM shall ship Exaeris’s requirements of
samples to such Exaeris facilities as Exaeris may designate. Samples
shall
be allotted on a per capita basis to the Exaeris sales force and
the TEAMM
sales force as modified by the expected amount of time and effort
to be
used by each sales force in Detailing the Product to each class of
account
and by the Sampling Program. All samples delivered to Exaeris shall
be
packaged in the same form and be of the same quality as Samples of
the
Product which TEAMM normally distributes to health care professionals
or
to the trade in the United States. TEAMM shall be allowed, for good
cause,
to require Exaeris to make an accounting for all samples by so notifying
Exaeris in writing.
|
| 9.2 |
Each
party shall comply with all laws and regulations applicable to the
distribution of Samples of the Product, including without limitation,
the
Prescription Drug Marketing Act of 1987 (“PDMA”). The parties shall keep
all records and reports required to be kept by applicable laws and
regulations and make its facilities available at reasonable times
during
business hours for inspection by the other party and representatives
of
governmental agencies. Each party shall promptly provide to the other
party a copy of all correspondence with FDA related to PDMA
compliance.
|
ARTICLE
10
SALES
COVERAGE
| 10.1 |
Exaeris
will call on * * * as defined in Exaeris’ Prescriber List, as well as
pharmacy and third party reimbursement customers. As Exaeris wishes
to add
new sales territories, Exaeris will inform TEAMM of this intention
in
writing and shall work with TEAMM to add these territories in a manner
which does not conflict with TEAMM’s coverage at that time, subject always
to TEAMM’s discretion in permitting this intended expansion by Exaeris.
TEAMM will be given first right to call on any physician that appears
on
both TEAMM and Exaeris current Prescriber List or expansion list.
Both
parties will collaborate to complement each other’s future sales coverage
territories on a best efforts basis. Exaeris and TEAMM will apprise
each
other of their respective sales territory expansion plans in respect
to
the Promotion of Product as they become known and as far in advance
as is
feasible so that these new territories can be accommodated to the
extent
commercially reasonable. Exaeris will provide TEAMM with a list of
prescribers in the required format ( as outlined in Exhibit 3) to
track
prescriptions through Prescriber Data source. New Prescribers may
be added
on a quarterly basis in a time frame mutually agreed upon in advance
of
the Quarter but not to be less than three (3) weeks in advance of
the
first day of the new Quarter, subject to acceptance and approval
by TEAMM.
TEAMM and Exaeris will exchange and compare each party’s Prescriber List
and Exaeris will make reasonable efforts to call on high prescribing
specialists (allergists, pulmonologists, pediatricians and primary
care)
included in their geographic area and not called on by TEAMM’s Sales
Representatives.
|
CONFIDENTIAL
TREATMENT
13
It
is
hereby expressly understood and agreed by and between TEAMM and Exaeris that
TEAMM shall at all times have the right to call on any and all prescribers,
either through its own Sales Representatives or through one or more co-promotion
arrangements, other than Exaeris’ Prescribers as that list may exist and be
updated from time to time through the Term of this Agreement.
| 10.2 |
Minimums:
|
| a. |
Exaeris
commits to having a minimum of ***
Detailing Sales Representatives hired and prepared to Promote as
of the
date of Launch with physician coverage of an average of *** target
physicians per Representative
|
| b. |
Exaeris’
physician coverage shall consist of a minimum of *** physicians with
a
target of *** allergists, *** pulmonologists, *** pediatricians and
***
primary care physicians. Further, Exaeris commits to a minimum of
***
physician Details in calendar year 2006 and *** physician details
in
calendar year 2007 and *** physician details for the period January-March
of 2008
|
| c. |
Additionally,
Exaeris shall cause its Sales Representatives to make a minimum of
***
pharmacy calls in the first *** months of launch in 2006 and ***
pharmacies calls per week per representative thereafter.
|
| d. |
Product
shall be in no less than a *** Detail Position throughout the term
of this
Agreement.
|
| e. |
Exaeris’
percent of prescriptions as reported by “Prescriber Data” shall not fall
below ***. For purposes of this agreement, the number of Sales
Representatives shall include the count of open territories. This
minimum
requirement is waived for the first *** reporting period (quarter)
following the launch date.
|
CONFIDENTIAL
TREATMENT
14
| 10.3 |
Activity
Audits.
No later than sixty (60) days after the conclusion of each Quarter,
Each
party will provide a report, based upon internal Detailing report
data
setting forth Details for the Products for the preceding Quarter
including
acknowledgments of Samples distributed for such quarter. In addition,
Exaeris agrees to make available to TEAMM, upon reasonable advance
notice,
such other books and records necessary to verify the accuracy of
such
report in respect of any Quarter ending not more than eighteen (18)
months
prior to the date of such request. Upon expiration of eighteen (18)
months
following the end of any Quarter, unless prior to such expiration,
based
upon such inspection, TEAMM has notified Exaeris of an issue regarding
such report, the report reflecting Exaeris Product Details for such
Quarter shall be binding; and Exaeris shall be released from any
liability
or accountability to TEAMM with respect to the number of Product
Details
given during such Quarter.
|
ARTICLE
11
COMPENSATION
| 11.1 |
TEAMM
shall pay Exaeris a Co-Promotion Payment based on Exaeris’ Percentage of
*** credited to the Exaeris’ Prescribers based on the terms as outlined
below. An example of the calculations in this article is provided
in ***.
|
| a. |
For
Invoiced sales of Product, Exaeris’ Co-Promotion Payment shall be based on
Exaeris’ Percentage of prescriptions generated by Exaeris’ Prescribers as
reported by Prescriber Data and determined by the calculation outlined
in
Article 11.1(b) applied against unit Invoiced Sales for the reporting
quarter at the Product Contribution-Co-Promotion payment per unit
outlined
in Article 11.1 (e)
|
| b. |
***
| c. |
Should
TEAMM and Exaeris mutually agree to dual coverage on a physician,
Exaeris
share of *** for dual coverage physician(s) will be *** of the ***
by such
physician(s).
|
| d. |
Exaeris’
Percentage of *** shall be calculated as an average over a Quarter.
However, the first period in which this percentage is averaged may
include
more than three months. For this period only, the *** will be averaged
over the longer period to adjust for stocking, however, the first
co-promotion payment will be made after the first full Quarter in
an
effort to provide a fair average of *** activity to be applied against
the
initial stocking of the Product. For example, if Quarter Sales begin
March 27, 2006 and Detailing begins May 1, 2006, the first full
Quarter would conclude at the end of September. In this example Exaeris
would receive a co-promotion payment after the completion of the
first
full quarter in the time frame outlined in this Agreement in 11.3.,
However, the co-promotion payment at the end of September would be
based
on a computation of Exaeris’ Percentage of *** over the period beginning
May 1st
through September 30th.
This percentage will be applied against Quarter Sales from March
27th
and
including Quarter Sales through the Quarter ending September 2006.
However
a payment of *** will be made to Exaeris for the first partial quarter
for
their efforts during training, launch and initial detailing period
and
paid six weeks after June 30, 2006. This payment will be credited
against
the total amount due Exaeris for the period from the Launch of the
Product
to the end of the first full quarter during which the product has
been
Detailed.
|
CONFIDENTIAL
TREATMENT
15
| e. |
Compensation
would be based on the following formula (example in Exhibit
1)
|
***
| 11.2 |
All
accruals for the first twelve months will be calculated using the
estimated percentages stated in 11.1(e). A reconciliation to actual
deductions will be calculated no later than 90 days following the
first
twelve months after Detailing begins. The actual percentages will
be the
basis for the estimated accruals from that point until the next
reconciliation.
|
| 11.3 |
Unless
otherwise indicated in this Section, TEAMM shall pay to Exaeris,
within
*** weeks of the close of each calendar Quarter in a Detailing Year,
a
Co-Promotion Payment equal to:
|
| a. |
The
Co-Promotion Payment payable to Exaeris for the Detailing Quarter
(calculated through the end of such calendar quarter) calculated
in
accordance with 11.1.
|
| b. |
Within
*** days after the close of each calendar quarter, TEAMM shall submit
to
Exaeris a reconciliation report outlining the calculation of the
payments
made to Exaeris.
|
| 11.4 |
Exaeris
agrees to compensate TEAMM for its prior development, marketing and
inventory carrying costs by development compensation payments totaling
***
to be paid as indicated below:
|
***
| 11.5 |
The
amount of each payment due to Exaeris pursuant to this article shall
be
adjusted by deducting all outstanding and unpaid TEAMM invoices presented
to Exaeris for development compensation payments, Samples and Product
Promotional Materials due to TEAMM under this Agreement during the
period
for which payment is calculated. In the event that such invoices
are in
excess of the amount due to Exaeris for such period, Exaeris shall
pay the
amount of such excess to TEAMM.
|
| 11.6 |
The
parties hereto expressly understand and agree that TEAMM shall be
entitled
to rely solely on the Prescriber Data to calculate Exaeris’ Percentage
used in calculating the Co-Promotion Payments due
Exaeris.
|
CONFIDENTIAL
TREATMENT
16
| 11.7 |
TEAMM
shall keep adequate records to account for the sums due to Exaeris
under
this Agreement. Such records shall be retained by TEAMM and shall
be made
available for reasonable review and audit, at the request and expense
of
Exaeris, by an independent certified public accountant appointed
by
Exaeris and reasonably acceptable to TEAMM for the purposes of verifying
TEAMM’s accounting reports hereunder. The documents from which the
accounting required by this Article have been prepared shall be retained
for the lesser of one (1) year after the completion of an audit thereof,
if an audit has been requested, or three (3) years from the date
of the
documents originate.
|
| 11.8 |
All
sums due to Exaeris shall be payable in U.S. dollars by TEAMM on
the
specified due date at the address set forth in Article
20.2.
|
CONFIDENTIAL
TREATMENT
17
ARTICLE
12
CONFIDENTIALITY
| 12.1 |
The
provisions of the Confidentiality and Non- Disclosure Agreement relating
to the non-disclosure and non-use of Proprietary Information belonging
to
either party, entered into previously by the parties, shall apply
to any
such information disclosed by either party to the other party in
connection with this Agreement, and the terms of that Confidentiality
and
Non- Disclosure Agreement, dated as of November 14, 2005 and signed
November 22, 2005, are hereby incorporated herein and made a part
hereof.
Any breach thereof shall be deemed to be a breach of this Agreement.
|
ARTICLE
13
PUBLICITY/PRESS
RELEASES
| 13.1 |
Neither
party shall distribute or have distributed any such information which
bears the name of the other without the prior written approval of
the
other, which approval shall not be unreasonably withheld. The Product
shall be represented solely as a TEAMM product. When packaged, the
Product
will bear the TEAMM name (as distributor) and the manufacturer’s name
only. All promotional and sales materials, not currently printed,
that are
intended for use by both parties in the Promotion of the Product
will
include the identity of both parties and will represent Exaeris as
a
co-promotion partner or as providing marketing support.
|
| 13.2 |
The
parties agree to issue a joint press release announcing the co-promotion;
provided that no publicity release or announcement concerning this
Agreement or the transactions contemplated hereby shall be issued
without
the advance written consent of the other, such consent not to be
unreasonably withheld, except as such release or announcement may
be
required by law, in which case the party making the release or
announcement shall, before making any such release or announcement,
afford
the other party a reasonable opportunity to review and comment upon
such
release or announcement. TEAMM and Exaeris recognize that disclosure
of
this Agreement (including copies of each) to the I.R.S.(Internal
revenue
Service), SEC (Security Exchange Commission) and other governmental
authorities may be required, and each waives the requirements of
this
subsection with respect to disclosure (and copies) to such
entities.
|
CONFIDENTIAL
TREATMENT
18
ARTICLE
14
TERM
AND TERMINATION
| 14.1 |
The
initial term of this Agreement shall commence on the Effective Date
and
shall continue for a period of twenty-four (24) consecutive months,
unless
earlier terminated in accordance with the provisions of thisArticle
14.
This Agreement is renewable for subsequent twelve (12) month periods
thereafter only by written agreement signed by both parties.
|
| 14.2 |
Notwithstanding
any other provision of this Agreement, either party may terminate
this
Agreement by notice in writing to the other upon or at any time after
the
occurrence of any of the following
events:
|
| a. |
If
the other commits a material breach of this Agreement, or fails to
perform
any material obligation under this Agreement, which (i) shall not
have
been remedied within ninety (90) days of the receipt by the other
of a
notice identifying the breach and (ii) continues to exist at the
time of
notice of termination; or Exaeris is unable to meet the minimum
requirements outlined in this agreement.
|
| b. |
If
the other is unable to pay its debts, becomes bankrupt or insolvent,
or
enters into liquidation whether compulsorily or voluntarily or compounds
with or convenes a meeting of its creditors or has a receiver appointed
over all or part of its assets or takes or suffers any similar action
in
consequence of a debt or ceases for any reason to carry on
business.
|
| 14.3 |
Notwithstanding
any other provision herein to the contrary, either party may terminate
this Agreement at any time for any reason by giving the other party
ninety
(90) days prior written notice of such termination, specifying the
effective date of such termination. Termination by Exaeris under
this
Article shall not release TEAMM from any obligation to pay Exaeris
any
sums due or accrued under this Agreement through the effective date
of
termination or release Exaeris from any obligation to pay TEAMM any
sums
due under this agreement. This payment obligation shall include,
without
limitation, the reconciliation of accrued discounts and rebate to
actual
amount incurred. In addition, should Exaeris terminate this agreement
without cause before all outstanding development compensation payments
are
received by TEAMM or TEAMM terminates due to Exaeris’ material breach,
Exaeris agrees to make immediate payment to TEAMM of the remaining
outstanding development compensation payments in recognition of the
credit
for stocking paid to Exaeris. If TEAMM terminates for any reason
other
than material breach by Exaeris, then Exaeris shall have no further
obligation to make any development payments which accrued subsequent to
the termination date.
|
| 14.4 |
The
expiration or termination of this Agreement shall not relieve the
parties
hereto of any liability which accrued hereunder prior to the effective
date of such expiration or termination nor preclude either party
from
pursuing all rights and remedies it may have hereunder or at law
or in
equity with respect to any breach of this Agreement nor prejudice
either
party’s right to obtain performance of any obligation provided for in this
Agreement which expressly survives termination or
expiration.
|
CONFIDENTIAL
TREATMENT
19
| 14.5 |
Any
dispute that may arise under this Agreement shall first be submitted
to
Mediation through the Commercial Oversight Committee created pursuant
to
Article 7 herein, and/or by mediators selected and appointed by the
Committee. If the Parties fail to resolve a dispute through mediation
within thirty (30) days of the request to mediate, and a party wishes
to
pursue the matter, each such dispute, controversy, that is not considered
an “Excluded Claim” shall be finally resolved by binding arbitration in
accordance with the Commercial Arbitration Rules of the American
Arbitration Association (“AAA”) with Supplementary Procedures for
Commercial Arbitration, and Supplementary Procedures for Large Complex
Cases. Judgment on the arbitration award may be entered in any court
having jurisdiction thereof. The arbitration shall be conducted by
a panel
of three (3) persons experienced in the pharmaceutical business:
within
thirty (30) days after initiation of arbitration, each party shall
select
one (1) Person to act as arbitrator and the two-party selected arbitrators
shall select a third arbitrator within thirty (30) days of their
appointment. If the arbitrators selected by the parties are unable
or fail
to agree upon the third arbitrator, the AAA shall appoint the third
arbitrator. The place of arbitration shall be Raleigh, North Carolina.
Either party may apply to the arbitrators for interim injunctive
relief
until arbitration award is rendered or the controversy is otherwise
resolved. Either party also may, without waiving any remedy under
this
Agreement, seek from any court having jurisdiction any injunctive
or
provisional relief necessary to protect the rights or property of
that
party pending the arbitration award. The arbitrators shall have no
authority to award punitive, special, consequential, or any other
type of
damages not measured by a party’s compensatory damages. Each party shall
bear its own costs and expenses and attorneys’ fees, and an equal share of
the arbitrators’ and any administrative fees of arbitration. Except to the
extent necessary to confirm an award or as maybe required by law,
neither
a party nor an arbitrator may disclose the existence, content, or
results
of arbitration without the prior written consent of both parties.
In no
event shall arbitration be initiated after the date a legal or equitable
proceeding based on the dispute, controversy or claim would be barred
by
the applicable North Carolina statute of limitations. As used in
this
Section, the term “Excluded Claim” shall mean a dispute, controversy or
claim that concerns (i) the validity or infringement of a patent,
trademark or copyright; or (ii) any antitrust, anti-monopoly or
competition law or regulations, whether or not
statutory.
|
CONFIDENTIAL
TREATMENT
20
| 14.6 |
Recognizing
that immediate and irreparable injury may result to the non-breaching
party (“Non-Breaching Party”), it’s business and property in the event of
a continuing breach of any of the provisions of Articles 3, 4, 5
and 10.2
by a party, that such provisions are necessarily of a special, unique
and
extraordinary nature and that any loss arising from a breach of any
such
provision may not reasonably and adequately be compensated by monetary
damages, and because this Agreement is based in significant measure
upon
such provisions, the party breaching any of the covenants of Articles
3,
4, 5 and 10.2 as applicable (“Breaching Party”), expressly agrees that in
the event of a violation of such provisions, the Non-Breaching Party
shall
be entitled, in addition to any other remedies and damages the
Non-Breaching Party could recover as a result of any such violation,
to
seek restraining orders and/or injunctions, both temporary and permanent,
in order to prevent any future violations
|
| 14.7 |
Consequences
of Termination.
|
| a. |
In
the event of termination of this Agreement under Article 14 hereof,
any
payments payable pursuant to Article 11 hereof shall be made only
with
respect to the Quarterly Sales generated prior to the effective date
of
such termination.
|
| b. |
Except
as set forth herein, any termination, cancellation or expiration
of this
Agreement shall not relieve either party of any obligation which
has
accrued prior to the date of such termination, cancellation or expiration,
including but not limited to, such party’s obligations under Article 11 of
this Agreement, which obligation shall remain in full force and effect
for
the period provided therein or if no period is provided,
indefinitely.
|
| c. |
In
the event of termination of this Agreement by Exaeris during first
six
months, except for cause due to material breach by TEAMM, Quarterly
Sales
will be adjusted to reflect more accurately the payment on sales
created
through prescriptions for that period rather than Product stocking
in
wholesalers and retail accounts. In this situation, the co-promotion
payment due to Exaeris would be calculated on prescriptions written
by
Exaeris Prescribers as reported through Prescriber
Data.
|
| d. |
Termination
of this Agreement does not relieve Exaeris from development compensation
payments agreed to and due to TEAMM. Notwithstanding the foregoing,
in the
unlikely event that the Product is not available for commercial
distribution for a period of six (6) months or greater subsequent
to the
Launch Date, Exaeris shall not responsible for any outstanding Development
compensation as due in Article 11.4 until such time as the Product
is once
again available for commercial
distribution.
|
| 14.8 |
Returned
Materials.
Upon the termination of this Agreement, TEAMM and Exaeris each shall
return to the other all information which it possesses or controls
that
belongs to the other, except that each may retain a copy for recordkeeping
purposes
|
CONFIDENTIAL
TREATMENT
21
ARTICLE
15
NON-COMPETE
| 15.1 |
Exaeris
agrees that during the Term of the Definitive Agreement and for one
(1)
year post-termination of the Agreement other than for breach by TEAMM
or
termination by TEAMM without cause, Exaeris and its affiliates will
not
develop, produce, market or sell or cause to be developed, produced,
marketed or sold any after market products that is or is designed
to
convert a metered dose inhaler (MDI) into a breath-activated delivery
with
dose counter which would compete directly with the Product (other
than the
Product) (“Competing Product”). TEAMM agrees during the term of the
Definitive Agreement, it will not develop, produce, market or sell
or
cause to be developed, produced, marketed or sold any Competing
Product.
|
ARTICLE
16
TRADEMARK
| 16.1 |
Exaeris
shall Promote and Detail the Product only under the
Trademark(s).
|
| 16.2 |
Each
party acknowledges the validity of the other party’s right, title and
interest in and to its or it’s partners Trademark(s) and shall not have,
assert or acquire any right, title or interest in or to any such
other
party’s Trademark(s).
|
| 16.3 |
Exaeris
shall use the product Trademark(s) only in the manner provided for
in
hereof or as otherwise directed by TEAMM and shall not use any Trademark
on any other goods or Products notwithstanding that such goods or
Products
are dissimilar to the Product or have a different
use.
|
ARTICLE
17
INSURANCE
| 17.1 |
TEAMM
shall at all times maintain insurance, including but not limited
to
product liability insurance, in commercially reasonable amounts for
its
respective obligations and potential liabilities in an amount no
less than
***
million dollars (***) per occurrence and in the aggregate.
TEAMM will name Exaeris as additionally insured under its product
liability policy. Exaeris shall at all times maintain general liability,
xxxxxxx’x compensation, auto and professional liability insurance, in
commercially reasonable amounts for its respective obligations and
potential liabilities in an amount no less than ***
million dollars (***)
per occurrence and in the aggregate. Exaeris will name TEAMM as
additionally insured under its general liability, auto and professional
liability policies. Each party shall, at the request of the other
party,
provide such evidence of such insurance as requested, including a
certificate of insurance.
|
CONFIDENTIAL
TREATMENT
22
ARTICLE
18
INDEMNIFICATION
| 18.1 |
(a)
Each party hereto (the “Indemnifying Party”) shall indemnify, defend and
hold harmless the other party hereto, its directors, officers, employees
and Affiliates (collectively, the “Indemnified Parties”) from and against
any and all Damages incurred or suffered by the Indemnified Parties
to the
extent arising out of any breach of this Agreement by the Indemnifying
Party or out of the sole or contributory negligence of the Indemnifying
Party in performing its obligations under this
Agreement.
|
(b)
Exaeris agrees to indemnify, defend and hold harmless the TEAMM Indemnified
Parties against any claim, action, suit or proceeding, settlement amounts or
damages, liabilities, costs and expenses (including reasonable attorneys' fees)
(“Claim”) by a third party alleging that any materials provided by Exaeris
(other than those received from TEAMM) infringes or violates any intellectual
property rights of such third party.
(c)
TEAMM
agrees to indemnify, defend and hold harmless the Exaeris Indemnified Parties
against any Claim by a third party (i) alleging that any materials provided
by
TEAMM (other than those received from Exaeris) infringes or violates any
intellectual property rights of such third party or (ii) arising out of the
use
of Product whether under product liability or otherwise.
| 18.2 |
Any
Indemnified Party shall notify the Indemnifying Parties of any potential
claim , and both parties agree that the indemnification provisions
set
forth in this agreement thereof shall apply to and govern any claims
for
indemnification under this
Agreement.
|
| 18.3 |
This
Section shall survive the expiration or termination of this
Agreement.
|
ARTICLE
19
REPRESENTATION
AND WARRANTIES
| 19.1 |
Exaeris
is a corporation duly organized and validly existing under the laws
of the
State of Delaware. Exaeris has all necessary corporate power and
authority
to enter into, and be bound by the terms and conditions of this agreement.
|
| 19.2 |
The
execution, delivery and performance by Exaeris of this Agreement
and each
agreement of instrument contemplated by this Agreement and the performance
of the transactions contemplated hereby and thereby, have been duly
authorized by all necessary corporate action by Exaeris. This Agreement
is, and each agreement or instrument contemplated by this Agreement,
when
executed and delivered by Exaeris in accordance with the provisions
hereof, will be the legal, valid and binding obligation of Exaeris,
in
each case enforceable against Exaeris in accordance with its terms,
except
as such enforceability may be limited by applicable bankruptcy,
insolvency, moratorium, reorganization, or similar laws from time
to time
in effect which affect the enforcement of creditors' rights generally
and
by legal and equitable limitations on the availability of specific
performance and other equitable remedies against Exaeris. All Persons
who
have executed this Agreement on behalf of Exaeris, or who will execute
on
behalf of Exaeris any agreement or instrument contemplated by this
Agreement, have been duly authorized to do so by all necessary corporate
action. Neither the execution and delivery of this Agreement by Exaeris,
or any such other agreement or instrument by Exaeris, nor the performance
of the obligations contemplated hereby and thereby, will (i) conflict
with
or result in any violation of or constitute a breach of any of the
terms
or provisions of, or result in the acceleration of any obligation
under,
or constitute a default under any provision of the Certificate of
Incorporation or By-laws of Exaeris or any contract or any other
obligation to which Exaeris is a party or to which it is subject
or bound,
or (ii) violate any judgment, order, injunction, decree or award
of any
court, administrative agency, arbitrator or government body against,
or
affecting or binding upon, Exaeris or upon the securities, property
or
business of Exaeris, or (iii) constitute a violation by Exaeris of
any
applicable law or regulation of any jurisdiction as such law or regulation
relates to Exaeris or to the property or business of Exaeris except
for
such conflict, acceleration, default, breach or violation that is
not
reasonably likely to have a material adverse effect on Exaeris’ ability to
perform its obligations under this Agreement or any agreement or
instrument contemplated hereby
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CONFIDENTIAL
TREATMENT
23
| 19.3 |
TEAMM
is a corporation duly organized and validly existing under the laws
of the
State of Florida. TEAMM has all necessary corporate power and authority
to
enter into, and be bound by the terms and conditions of this agreement.
|
| 19.4 |
The
execution, delivery and performance by TEAMM of this Agreement and
each
agreement of instrument contemplated by this Agreement and the performance
of the transactions contemplated hereby and thereby, have been duly
authorized by all necessary corporate action by TEAMM. This Agreement
is,
and each agreement or instrument contemplated by this Agreement,
when
executed and delivered by TEAMM in accordance with the provisions
hereof,
will be the legal, valid and binding obligation of TEAMM, in each
case
enforceable against TEAMM in accordance with its terms, except as
such
enforceability may be limited by applicable bankruptcy, insolvency,
moratorium, reorganization, or similar laws from time to time in
effect
which affect the enforcement of creditors' rights generally and by
legal
and equitable limitations on the availability of specific performance
and
other equitable remedies against TEAMM. All Persons who have executed
this
Agreement on behalf of TEAMM, or who will execute on behalf of TEAMM
any
agreement or instrument contemplated by this Agreement, have been
duly
authorized to do so by all necessary corporate action. Neither the
execution and delivery of this Agreement by TEAMM, or any such other
agreement or instrument by TEAMM, nor the performance of the obligations
contemplated hereby and thereby, will (i) conflict with or result
in any
violation of or constitute a breach of any of the terms or provisions
of,
or result in the acceleration of any obligation under, or constitute
a
default under any provision of the Certificate of Incorporation or
By-laws
of TEAMM or any contract or any other obligation to which TEAMM is
a party
or to which it is subject or bound, or (ii) violate any judgment,
order,
injunction, decree or award of any court, administrative agency,
arbitrator or government body against, or affecting or binding upon,
TEAMM
or upon the securities, property or business of TEAMM, or (iii) constitute
a violation by TEAMM of any applicable law or regulation of any
jurisdiction as such law or regulation relates to TEAMM or to the
property
or business of TEAMM except for such conflict, acceleration, default,
breach or violation that is not reasonably likely to have a material
adverse effect on TEAMM’s ability to perform its obligations under this
Agreement or any agreement or instrument contemplated
hereby.
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CONFIDENTIAL
TREATMENT
24
| 19.5 |
TEAMM
hereby acknowledges that (i) TEAMM licenses the marketing rights
to the
Product in the United States under and pursuant to the terms and
conditions of that certain Development and License Agreement by and
between TEAMM and Respirics, and (ii) that Respirics has in turn
authorized TEAMM to the market, sell and distribute the Products
in the
United States pursuant to the terms and conditions of the Respirics
Marketing Agreement.
|
| 19.6 |
It
is understood and agreed by TEAMM and Exaeris that TEAMM purchases
the
Product from a contract manufacturer controlled by Respirics, which
is
responsible for determining and insuring that all Product shall as
of the
date shipped to TEAMM, fully conform to the Specifications and have
been
manufactured in compliance with the 510(k) and all applicable laws.
TEAMM
makes no representation or warranty as to any product, expressed
or
implied, either in fact or by operation of law, by statue or otherwise,
and TEAMM specifically disclaims any and all implied or statutory
warranties, including without limitation, any warranty of fitness
for a
particular purpose or warranty of noninfringement.
|
ARTICLE
20
MISCELLANEOUS
| 20.1 |
Neither
party shall assign this Agreement nor any of their respective rights
or
obligations hereunder without the prior written consent of the other
party, except that either party may assign this Agreement to any
of its
Affiliates or to any Person or entity to which substantially all
of its
assets are transferred by operation of law or otherwise, including,
but
without limitation, by merger or transfer of stock. Any other attempted
assignment without such consent shall be void. Any assignee or transferee
of this Agreement and/or the rights or obligations hereunder shall
expressly assume in writing all obligations of the assign or/transferor
pursuant to this
|
| 20.2 |
Notices.
All notices or other communications required or permitted to be given
hereunder shall be in writing and shall be deemed to have been duly
given
if delivered by hand or mailed first class, postage prepaid, by registered
or certified mail, return receipt requested (notices shall be deemed
to
have been given on the date received) as
follows:
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CONFIDENTIAL
TREATMENT
25
a.
If
to
Exaeris, as follows:
Exaeris
Pharmaceuticals, Inc.
000
Xxxxxx Xx
Xxxxx,
XX
00000
Attn
to:
Xxxxxxx Xxxxxxx
With
a
copy to:
Exaeris
Pharmaceuticals, Inc.
Attn:
General Counsel
b. If
to
TEAMM, as follows:
TEAMM
Pharmaceuticals, Inc
0000
Xxxxxx Xxxxxx Xxxxxxx
Xxxxx
000
Xxxxxxxxxxx,
XX 00000
Attn
to:
Xxxxxx X. Xxxx
With
a
copy to:
Accentia
Biopharmaceuticals, Inc. / TEAMM Pharmaceuticals, Inc
000
X.
Xxxx Xxxx Xxxxxx
Xxxxx,
XX
00000
Attn:
General Counsel
| c. |
or
in any case to such other address or addresses as hereafter shall
be
furnished as provided in this article by any party hereto to the
other
party.
|
| 20.3 |
Waiver:
Remedies.
No delay on the part of Exaeris or TEAMM in exercising any right,
power or
privilege hereunder shall operate as a waiver thereof, nor shall
any
waiver on the part of either Exaeris or TEAMM of any right, power
or
privilege hereunder operate as a waiver of any other right, power
or
privilege hereunder nor shall any single or partial exercise of any
right,
power or privilege hereunder preclude any other or further exercise
thereof or the exercise of any other right, power or privilege hereunder.
|
| 20.4 |
Entire
Agreement.
This Agreement and all agreements and documents referenced herein
or
contemplated hereby constitute the entire agreement between the parties
with respect to the subject matter hereof and supersedes all prior
agreements or understandings of the parties relating
thereto.
|
| 20.5 |
Amendment.
This Agreement may be modified or amended only by written agreement
of the
parties hereto.
|
CONFIDENTIAL
TREATMENT
26
| 20.6 |
Counterparts.
This Agreement may be executed in any number of counterparts, each
of
which shall be deemed an original but all of which together shall
constitute a single instrument.
|
| 20.7 |
Governing
Law.
This Agreement shall be governed and construed in accordance with
the laws
of the State of Florida-excluding any choice of law rules which may
direct
the application of the law of another
state.
|
| 20.8 |
Captions.
All section titles or captions contained in this Agreement, in any
Article
referred to herein or in any Exhibit annexed hereto, and the table
of
contents, if any, to this Agreement are for convenience only, shall
not be
deemed a part of this Agreement and shall not affect the meaning
or
interpretation of this Agreement.
|
| 20.9 |
No
Third Party Rights.
No provision of this Agreement shall be deemed or construed in any
way to
result in the creation of any rights or obligations in any Person
not a
party to this Agreement
|
| 20.10 |
Relationship
of the Parties.
Each party understands and agrees that it has no authority to assume
any
obligation on behalf of the other party and that, except as expressly
permitted herein, it shall not hold out to third parties that it
has any
authority to act on the others party’s behalf (specifically with respect
to any new buying customer, Exaeris may not bind TEAMM to any business
arrangement whatsoever). Unless otherwise expressly stated herein,
each
party shall be responsible for its own expenses relating to its
performance under the Agreement and shall not incur expenses for
the other
parties account unless expressly authorized in writing to do
so.
|
| 20.11 |
Headings.
All headings are for reference purposes only and shall not in any
way
affect the meaning or interpretation of this
Agreement.
|
| 20.12 |
Severability.
Both parties hereto expressly agree and contract that it is not the
intention of either party to violate any public policy, statutory
or
common laws, rules, regulations, treaties or decisions of any government
or agency thereof. If any provision of part thereof contained in
this
Agreement is declared invalid by any court of competent jurisdiction
or a
government agency having jurisdiction, each such declaration shall
not
affect the remainder of the provision or the other provisions and
each
shall remain in full force and effect.
|
| 20.13 |
Force
Majeure.
If either party is prevented from complying, either totally or in
part
with any of the terms or provisions set forth herein, by reason of
force
majeure, including, by way of example and not of limitation, fire,
flood,
explosion, storm, strike, lockout or other labor dispute, riot, war,
rebellion, accidents, acts of God, acts of governmental agencies
or
instrumentalities, failure of suppliers or any other external cause
or
externally induced casualty beyond its reasonable control, whether
similar
to the foregoing contingencies or not, said party shall provide written
notice of same to the other party. Said notice shall be provided
within
three (3) business days of the occurrence of such event and shall
identify
the requirements of this Agreement or such of its obligations as
may be
affected, and to the extent so affected, said obligations shall be
suspended during the period of such disability. The party prevented
from
performing hereunder shall use all commercially reasonable efforts
to
remove such disability, and shall continue performance whenever such
causes are removed. The party so affected shall give to the other
party a
good faith estimate of the continuing effect of the force majeure
condition and the duration of the affected party’s nonperformance. If the
period of any previous actual nonperformance of Exaeris because of
Exaeris
force majeure conditions plus the anticipated future period of Exaeris
nonperformance because of such conditions will exceed an aggregate
of one
hundred eighty (180) days within any twenty-four (24) month period,
TEAMM
may terminate this Agreement by written notice to Exaeris. If the
period
of any previous actual nonperformance of TEAMM because of TEAMM force
majeure conditions plus the anticipated future period of TEAMM
nonperformance because of such conditions will exceed an aggregate
of one
hundred eighty (180) days within any twenty-four (24) month period,
Exaeris may terminate this Agreement by written notice to TEAMM.
When such
circumstances as those contemplated herein arise, the parties shall
discuss in good faith, what, if any, modification of the terms set
forth
herein may be required in order to arrive at an equitable
solution.
|
CONFIDENTIAL
TREATMENT
27
IN
WITNESS WHEREOF,
the
parties have caused this Agreement to be duty executed and delivered on the
day
and year first above written.
| TEAMM Pharmaceuticals, Inc. | Accentia Biopharmaceuticals, Inc | ||
| |
|
|
|
| By: | /s/ Xxxxxx X. Xxxx | By: | /s/ Xxxxx X’Xxxxxxx, Xx. |
| Xxxxxx X. Xxxx | Xxxxx X’Xxxxxxx, Xx., MD | ||
| President and Chief Operating Officer | Chairman | ||
| Exaeris, Inc | |||
| By: | /s / Xxxxxxx Xxxxxxx | ||
| Xxxxxxx
Xxxxxxx
President
and Chief Operating Officer
|
|||
CONFIDENTIAL
TREATMENT
28
EXHIBIT
1
Example
of Compensation Calculation
***
CONFIDENTIAL
TREATMENT
EXHIBIT
2
CONFIDENTIAL
TREATMENT
EXHIBIT
3
Format
to submit physician data for inclusion into Prescriber Data Source and
Prescriber List
Excel
Spreadsheet
|
ME
Number
|
Last
Name
|
First
Name
|
Middle
Initial
|
Street
Address
|
City
|
State
|
Zip
Code
|
Specialty
|
Territory
number
|
CONFIDENTIAL
TREATMENT
EXHIBIT
4
EXAMPLE:
Calculation of Co-Promotion Payment to Exaeris
***
CONFIDENTIAL
TREATMENT
