* Certain portions of this exhibit
have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
Contract Sales and Services
Agreement
Cumberland Pharmaceuticals,
Inc.
Cardinal Health Contract Sales
& Services
Cumberland Pharmaceuticals
Dedicated Sales Force
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Definitions and
References to Cardinal Health
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Page
3
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Appointment of
Cardinal Health; General Scope of Activities
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Page
5
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Compensation
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Page
8
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Representations, Warranties and
Covenants
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Page
9
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Status of
Cardinal Health and the Representatives
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Page
10
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Training
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Page
11
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Samples
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Page
11
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Trademarks and
Intellectual Property Rights
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Page
12
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Communications;
Monitoring the Program
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Page
12
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Insurance
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Page
13
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Adverse
Reaction Reporting and Regulatory Matters
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Page
14
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Return/Recall
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Page
15
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Term and
Termination
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Page
16
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Recordkeeping;
Audit Rights
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Page
18
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Indemnification
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Page
18
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Notice
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Page
21
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Miscellaneous
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Page
21
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List of
Products
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Page
25
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Definition of
Territory
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26
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Service Fees
and Payment Schedule
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27
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-2-
This AGREEMENT
(“Agreement”) is dated as of May 16, 2006 by and
between Cardinal Health PTS, LLC (“Cardinal Health”)
with a place of business at 7000 Cardinal Place, Dublin, Ohio, and
Cumberland Pharmaceuticals, Inc. (“Cumberland”), having
a principal place of business at 2525 West End, Suite 950,
Nashville, Tennessee 37203.
Cumberland is a
Tennessee-based company which focuses on the acquisition,
marketing, and distribution of a portfolio of niche pharmaceutical
products. Cardinal Health provides medical representatives who
Detail (as hereinafter defined) pharmaceutical products for third
parties. Cumberland desires Cardinal Health to provide
representatives to Detail certain products as determined and
directed by Cumberland in the geographical territory hereinafter
specified, pursuant to the terms and conditions of this Agreement,
and Cardinal Health desires to provide the Representatives and
perform such services pursuant to the terms and conditions set
forth in this Agreement.
The parties hereby
agree as follows:
DEFINITIONS AND REFERENCES TO
CARDINAL HEALTH
1.1.
Definitions. The following terms when used in this Agreement
shall, except where the context otherwise requires, have the
following meanings:
(a) “Act”
means the Federal Food, Drug and Cosmetic Act, as amended, and the
regulations promulgated thereunder from time to time.
(b) “Affiliate”
means any corporate or non-corporate business entity that controls,
is controlled by, or is under common control with a party to this
Agreement. A corporation or non-corporate business entity shall be
regarded as in control of another corporation if it owns or
directly or indirectly controls at least forty percent (40%) of the
voting stock of the other corporation, or (i) in the absence
of the ownership of at least forty percent (40%) of the voting
stock of a corporation or (ii) in the case of a non-corporate
business entity, if it possesses directly or indirectly, the power
to direct or cause the direction of the management and policies of
such corporation or non-corporate business entity, as
applicable.
(c) “Agency”
means any governmental regulatory authority in the Territory
responsible for granting approvals for the sale or maintaining
regulatory oversight of the Products, including, without
limitation, the FDA.
(d) “Cardinal
Health” means Cardinal Health PTS, LLC and shall be deemed to
include the Representatives and Managers.
-3-
(e) “Detail”
means an interactive, face-to-face visit by a Representative with a
Target Customer or his or her legally empowered designee in the
Territory, during which the FDA-approved indicated uses, safety,
effectiveness, contraindications, side effects, warnings and other
relevant characteristics of one or more of the Products (as defined
herein) are described by the Representative in a fair and balanced
manner consistent with the requirements of the Act, and using, as
necessary or desirable, the Product Labeling (as defined herein)
and the Product Promotional Materials (as defined herein).
“Product Detail” means Detail of a Product between
Target Customer and Representative. When used as a verb,
“Detail” or “Detailing” shall mean to
engage in a Detail as defined in this Section 1.1(f).
(f) “FDA”
means the United States Food and Drug Administration and any
successor agency having substantially the same
functions.
(g) “Manager”
means an individual hired by and retained as an employee of
Cardinal Health to oversee activities of Representatives under this
Agreement, including a project manager.
(h) “PDMA”
means the Prescription Drug Marketing Act of 1987, as amended, and
the regulations promulgated thereunder from time to
time.
(i) “Product
Labeling” means all labels and other written, printed, or
graphic matter provided by Cumberland including (i) any
container or wrapper utilized with a Product, or (ii) any
written material accompanying a Product, including, without
limitation, Product package inserts.
(j) “Product
Promotional Materials” means all written, printed or graphic
material provided by Cumberland, including Product Labeling,
intended for use by Representatives during a Detail, including
visual aids, file cards, premium items, clinical studies, reprints,
drug information updates and any other promotional support items
that Cumberland deems necessary or appropriate to conduct the
Program. Product Promotional Materials shall include FDA approved
indicated uses, safety, effectiveness, contraindications, side
effects, warnings and other relevant characteristics of each of the
Products.
(k) “Products”
means the pharmaceutical products to be detailed by Representatives
and marketed by Cumberland as set forth on attached
Schedule 1.1(k) and such other products as may be added by
Cumberland from time to time to Schedule 1.1(k) attached
hereto.
(l) “Program”
means the program of Detailing to be conducted by the
Representatives pursuant to this Agreement beginning as of
September 5, 2006 and continuing thorugh the remainder of the
Term, as defined in Section 14.1.
(m) “Representative”
and “Representatives” mean an individual or individuals
hired by and retained as an employee of Cardinal Health to conduct
Detailing of Cumberland Products only in connection with the
Program.
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(n) “Target”
or “Target Customer” means a physician or other
specialist identified by Cumberland.
(o) “Territory”
means the geographical area specified in the attached
Schedule 1.1(o).
ARTICLE II
APPOINTMENT OF CARDINAL HEALTH; GENERAL SCOPE OF
ACTIVITIES
2.1.
Detailing. Cardinal Health shall provide twenty four
(24) Representatives to engage in Product Detail activities in
the Territory. Cardinal Health shall assign Representatives for
such Target Customers, in such numbers, and in such Territories as
shall be designated by Cumberland during the term of this
Agreement. Each Representative shall make Product Details to his or
her assigned Target Customers based on any reasonable general
direction given by Cumberland’s designated management team.
The duties of such Representatives shall be exclusively to Detail
the Products and perform other related activities reasonably agreed
upon by Cardinal Health as deemed necessary for the establishment
and maintenance of new and existing customers of the Products in
the Territories. Cumberland shall at all times retain the right to
promote the Products by whomever, wherever, and to whomever it
chooses.
2.2 Furnishing
Managers . Cardinal Health shall provide two Managers to
oversee the activities of Representatives and to perform this
Agreement in such numbers and for such Territories (when relevant)
as mutually agreed upon by Cardinal Health and
Cumberland.
2.3. Scope of
Activities. The parties shall perform the following activities
as applicable to each in connection with the Program:
(a) Cardinal
Health shall have sole and exclusive authority to discipline or
terminate the employment of Representatives. Cumberland may
reasonably request that a Representative or Manager be terminated
or reassigned if such Representative’s or Manager’s
activities or conduct are not adequately achieving the performance
goals of the Product, or if the Representative or Manager fails to
comply with all applicable laws, regulations, and Cumberland
requirements for Detailing the Product. Cardinal Health shall use
its best efforts to comply with such request; provided that such
action complies with applicable laws and is in accordance with
Cardinal Health’s policies and procedures, as determined by
Cardinal Health’s human resources manager. In the event
Cardinal Health determines that its policies and procedures or
applicable laws prohibit the termination or reassignment of any
Representative so requested by Cumberland, it shall notify
Cumberland of such determination and submit a corrective action
plan for Cumberland’s approval.
(b) Cardinal
Health shall cause each Representative to attend and successfully
complete the Training Program (as defined in Section 6.1)
conducted by Cumberland for each of the Products prior to
participating in the Program. Any such Representative who shall not
successfully complete all such requirements shall be removed and
replaced by another Representative who shall comply with such
requirements.
-5-
(c) Cumberland
shall provide the Representatives without cost with sufficient
quantities of the Product Promotional Materials and Product
Labeling for the performance of Detailing. Cumberland shall be
solely responsible for the preparation, content, and method of
distribution of the Product Promotional Materials and the Product
Labeling. In connection with the Detailing of the Products, the
Representatives shall use only the Product Labeling and the Product
Promotional Materials provided by Cumberland; and under no
circumstances shall Cardinal Health or the Representatives develop,
create, or use any other promotional material or literature for the
Detailing of the Products. Cumberland shall advise Cardinal Health
immediately of any inaccuracy or incompleteness of the Product
Promotional Materials or the Product Labeling, and upon such notice
Cardinal Health and the Representatives shall immediately cease the
use of any portion or all of the Product Promotional Materials or
Product Labeling so identified by Cumberland.
(d) Cardinal
Health shall instruct the Representatives to limit their verbal
statements and claims regarding the Products, including efficacy
and safety, to those that are consistent with the Product Labeling
and the Product Promotional Materials. The Representatives shall
not add, delete, or modify claims of efficacy or safety in the
Detailing of the Products, nor make any changes (including
underlining or otherwise highlighting any language or adding any
notes thereto) in the Product Promotional Materials.
Representatives shall not make any disparaging, untrue, or
misleading statements about Cumberland or its Affiliates,
employees, competitors, or competing products. Representatives
shall Detail the Products in strict adherence to all applicable
laws, regulations, and professional requirements, including, but
not limited to, the Act, the Medicare and Medicaid Anti-Kickback
Statute, and the American Medical Association Gifts to Physicians
from Industry Guidelines.
(e) The
Representatives shall remain under the direct authority and control
of Cardinal Health, but shall cooperate with the members of
Cumberland and shall receive advice and direction related to Detail
activities on the Products from Cumberland and Cardinal Health
mutually. Cumberland shall make all decisions with respect to the
overall strategy in connection with the Detailing of the Products.
Any Cumberland personnel interacting with Cardinal Health
Representatives shall not discipline the Representatives or
implement terms or conditions of employment or personnel policies
and/or practices with respect to the Representatives. Cumberland
shall provide Cardinal Health with copies of all reports,
memoranda, audits and other data it develops pertaining to
(i) the Representatives, Detailing, and the Program within
30 days of the preparation of such documents, and
(ii) any negligent or wrongful acts or omissions of
Representatives as promptly as practicable.
(f) In
the event Cardinal Health supplies Representatives and Managers
with fleet vehicles for their use in performing the Detailing as
described in the Schedules of this Agreement, Cumberland shall
reimburse Cardinal Health for all of its out-of-pocket costs
related to using such vehicles for Detailing, including but not
limited to costs related to owning, leasing, maintaining, insuring,
and/or operating such vehicles (including fuel costs). Cumberland
shall reimburse Cardinal Health for all reasonable out-of-pocket
costs and expenses (i.e., airline tickets and other travel
expenses, hotel, rent-a-car, business meals, travel meals)
of
-6-
Representatives
and Managers in connection with performing services pursuant to
this Agreement. Cumberland and Cardinal Health shall establish a
mutually acceptable budget for the costs and expenses referenced in
this subparagraph for each Territory.
(g) Cumberland
shall provide Cardinal Health with a list of Target Customers in
the Territory and with data on prescriptions and sales in the
Territory for Cardinal Health’s use in performing this
Agreement. Cumberland shall also provide Cardinal Health with other
sales and marketing information concerning the Products that
Cumberland obtains or prepares during the term of this Agreement
and deems useful to Cardinal Health.
2.4. Orders for
Products . Cumberland shall be solely responsible for
establishing the terms and conditions of the sale of the Products,
including without limitation, the price at which the Products will
be sold, whether sales of the Products will be subject to any
discounts, the method of distribution of the Products, and whether
any credit will be granted or refused in connection with the sale
or return of any Product. Cumberland shall be exclusively
responsible for accepting and filling all purchase orders for the
Products, billing and returns for the Products, and all other
activities in connection with the sale and delivery of the
Products, other than Detailing. If Cardinal Health or the
Representatives receive an order for the Products, they shall
immediately transmit such order to Cumberland for further handling
and communications with the submitter of the order, including
acceptance or rejection, which shall be in Cumberland’s sole
discretion.
2.5.
Representatives’ Activity
(a) Subject
to Cumberland’s obligations and representations and
warranties in this Agreement, any negligent or wrongful act or
omission on the part of the Representatives (both individually and
as a group) that occur during the term of this Agreement and that
arise during the course and within the scope of their employment
with Cardinal Health pursuant to this Agreement shall be deemed to
be negligent or wrongful acts or omissions of Cardinal Health.
Notwithstanding the foregoing, any acts or omissions of the
Representatives pursuant to the exclusive direction, control or
supervision of Cumberland or its employees or agents shall not be
deemed to be negligent or wrongful acts or omissions of Cardinal
Health.
(b) Each
party shall notify the other in writing as promptly as practicable
of any such material alleged negligent or wrongful acts or
omissions on the part of the Representatives of which it becomes
aware along with a plan to remedy such acts or omissions, and
Cumberland shall provide Cardinal Health with a reasonable
opportunity to remedy such acts or omissions, and if indicated, to
replace the involved Representatives.
2.6
Vacancies/Turnover . In the event of a Representative
vacancy due to resignation, reassignment or termination of a
Representative, Cardinal Health shall fill any such vacancy within
a six (6) week period. Cumberland shall be responsible for
paying the Service Fees (as defined in Section 3.1 below)
during such vacancy, unless such vacancy exceeds the six
(6) week period, in which event, the associated Service Fees
for such vacancy shall be suspended after the six (6) week
period and shall resume once the vacancy is filled by Cardinal
Health. All recruiting and other related expenses for filling a
vacancy shall be borne by Cardinal Health;
-7-
provided,
however, that Cumberland shall be responsible for all recruiting
and other related expenses for filling any vacancy occurring
pursuant to Cumberland’s request for reassignment or
termination other than a request pursuant to Section 2.5(b) or
resulting from the Representative’s failure to comply with
any one or more of the provisions of Section 2.3. In addition,
if Cumberland desires to interview any candidates, Cumberland shall
bear its own cost of attending any final interview conducted by
Cardinal Health or the costs of any separate interview arranged for
by Cumberland.
2.7 Management
Reports . Cardinal Health or its third party designee shall
provide Cumberland with monthly reports in the form agreed between
Cumberland and Cardinal Health within fifteen (15) days after
the end of each month. At the request of Cumberland, Cardinal
Health shall furnish Cumberland at reasonable times such
documentation as Cumberland reasonably requests for purposes of
verifying the accuracy of any monthly report.
2.8 Project
Manager . Cardinal Health shall appoint a Project Manager to
serve as a liaison between Cardinal Health, Representatives and
Cumberland regarding the performance by Cardinal Health and
Cumberland of their respective obligations under this
Agreement.
2.9
Non-compete . During the term hereof and until the first
anniversary of the expiration thereof, the Representatives shall
not, directly or indirectly, solicit or influence or attempt to
solicit or influence any Target Customer to acquire pharmaceutical
products manufactured by a competitor of Cumberland for a laxative
product, an oral rehydration solution or other Products added to
Schedule 1.1(k) by Cumberland.
3.1. Amount and
Time of Payment . For services hereunder, Cumberland shall pay
to Cardinal Health the fees set forth in Schedule 3.1 attached
hereto and incorporated by reference (the “Service
Fees”), which shall be payable as set forth in the payment
schedule set forth therein.
3.2
Cumberland’s Hiring of Representatives. Cumberland
shall not solicit, directly or indirectly, any Representative or
other employee of Cardinal Health to terminate their employment
with Cardinal Health and/or hire any such Representative or
employee during the Term of this Agreement without the prior
written consent of Cardinal Health, which consent shall not be
unreasonably withheld or delayed. At the expiration or termination
of this Agreement, Cumberland shall have the right to hire as its
own employee or as an independent contractor or agent any one or
more of the Representatives or Managers (collectively, the
“Targeted Employees”). Cumberland shall have the right
to negotiate with any Targeted Employee concerning the terms on
which Cumberland might hire that Targeted Employee prior to the end
of the Term only upon the prior written consent of Cardinal Health,
which shall not be unreasonably withheld or delayed. Cardinal
agrees not to interfere with or restrict in any manner
Cumberland’s solicitation and hiring of the Targeted
Employees and Cardinal Health will assist Cumberland in the
transition of Targeted Employees from Cardinal Health to
Cumberland.
-8-
3.3.
Reimbursement of Expenses . All expenses of Cardinal Health
for which Cumberland is obligated to reimburse Cardinal Health as
expressly provided in this Agreement, including but not limited to
travel expenses and vehicle expenses under Section 2.3(e), shall be
paid by Cumberland within [***] days after Cardinal Health has
submitted a statement itemizing such expenses. Cardinal Health
shall submit such expense statements to Cumberland
monthly.
3.4 Past Due
Amounts . All amounts owing by Cumberland to Cardinal Health
pursuant to this Agreement that are not timely paid by Cumberland
will bear interest at the rate of twelve (12%) per annum from the
due date. An invoice will be considered late and begin to accrue
interest if unpaid 30 days past its due date.
ARTICLE IV
REPRESENTATIONS, WARRANTIES AND COVENANTS
4.1. By
Cardinal Health. Cardinal Health represents, warrants, and
covenants to Cumberland, as of execution of this Agreement and
during the term of this Agreement, as follows:
(a) that
Cardinal Health and the Representatives shall perform the Detailing
in a professional and timely manner;
(b) that
Cardinal Health and the Representatives shall comply with all laws,
rules and regulations that apply to the performance of services
under this Agreement, including but not limited to the PDMA, the
Medicare and Medicaid Anti-Kickback Act (42 U.S.C. §
1320a-7b(a)), the Civil False Claims Act (31 U.S.C. §
3729(a)), Sections 1128A, 1128B, and 1877 of the Social
Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn),
the Health Care Fraud Act (18 U.S.C. § 1347), and the Criminal
False Claims Act (18 U.S.C. § 287), as amended from time to
time, as well as similar applicable state laws; and
(c) that
Cardinal Health is under no obligation to any third party that
would prevent the execution of this Agreement or interfere with its
performance under this Agreement.
4.2. By
Cumberland . Cumberland represents, warrants, and covenants to
Cardinal Health, as of execution of this Agreement and during the
term of this Agreement, as follows:
(a) that
Cumberland is under no obligation to any third party that would
prevent the execution of this Agreement or interfere with its
performance under this Agreement;
(b) that
Cumberland shall comply with all laws, rules and regulations that
apply to the Products and their sale, the Program, and this
Agreement, including but not limited to the Act, the PDMA, the
Medicare and Medicaid Anti-Kickback Act (42 U.S.C. §
1320a-7b(a)), the Civil False Claims Act (31 U.S.C. §
3729(a)), Sections 1128A, 1128B, and 1877 of the Social
Security Act (42 U.S.C. §§ 1320a-7a, -7b, and 1395nn),
the Health Care Fraud Act (18
-9-
U.S.C. §
1347), and the Criminal False Claims Act (18 U.S.C. § 287), as
amended from time to time, as well as similar applicable state
laws;
(c) that
the Product Labeling and Product Promotional Materials are
accurate, complete, and in compliance with the Act and all
applicable rules and regulations of the FDA; and
(d) that
to the best knowledge of Cumberland, the manufacture, sale, and
distribution of the products do not and will not during the term of
this Agreement, infringe any patent or other proprietary rights of
third parties, and the Products have all necessary governmental
approvals and may be lawfully Detailed and sold by Cumberland and
the Representatives.
ARTICLE V
STATUS OF CARDINAL HEALTH AND THE
REPRESENTATIVES
5.1. Cardinal
Health Independent Contractor. Cardinal Health is being
retained and shall perform hereunder strictly as an independent
contractor. Representatives and Managers of Cardinal Health
performing services hereunder shall not be, and shall not be
considered to be, employees of Cumberland for any purpose, and
shall at all times remain employees of Cardinal Health, subject to
Section 3.3. Neither party shall have any responsibility for
the hiring, termination, compensation, benefits or other conditions
of employment of the other party’s employees, except as
otherwise provided in this Agreement.
5.2. No
Cumberland Benefits. While employees of Cardinal Health, the
Managers and Representatives are not eligible to participate in any
benefits programs or sales bonuses offered by Cumberland to its
employees, or in any pension plans, profit sharing plans, insurance
plans or any other employee benefit plans offered from time to time
by Cumberland to its employees, provided that the Representatives
shall be eligible to participate in Cumberland sales contests and
bonus plans if so requested by Cumberland and approved by Cardinal
Health. Cardinal Health acknowledges and agrees that Cumberland
does not, and will not, maintain or procure any worker’s
compensation or unemployment compensation insurance for or on
behalf of the Managers or Representatives while they are employees
of Cardinal Health. Cardinal Health acknowledges and agrees that it
shall be solely responsible for paying all salaries, wages,
benefits and other compensation which its employees (including
Representatives and Managers) may be entitled to receive in
connection with the performance of the services
hereunder.
5.3 Sales, Use
and Excise Taxes. If any state or local government or other
taxing authority determines that sales, use or excise Taxes
(“Taxes”) are applicable to Cardinal Health’s
services performed hereunder, Cardinal Health shall promptly accrue
and Cumberland shall pay such Taxes on behalf of Cardinal Health to
the appropriate taxing authorities. In addition, Cumberland shall
be responsible for the payment of any applicable Taxes related to
Cumberland’s supply to Cardinal Health of Product Promotional
Materials and Product Samples.
5.4. No Joint
Venture. Nothing contained in this Agreement shall be construed
as creating a joint venture or, except as otherwise provided
herein, as granting to either party the
-10-
authority to
bind or contract any obligations in the name of or on the account
of the other party or to make any guarantees or warranties on
behalf of the other party.
(a) Cumberland
shall conduct a training program for new Representatives and
Managers prior to participating in the Program, which shall include
such medical and technical
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