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Title: |
Agreement |
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Entities: |
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Date: |
2002 |
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Preview shows 14KB of 62KB total |
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$47 |
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ID: |
#308949 |
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AGREEMENT
This AGREEMENT ("Agreement") is dated as of September 24, 2002 by and
between RedKey, Inc., an Ohio corporation, doing business as Cardinal Health
Sales and Marketing Services ("Vendor"), with its principal place of business at
7000 Cardinal Place, Dublin, Ohio, and Nastech Pharmaceuticals, Inc.
("Company"), a Delaware corporation, with its principal place of business at
3450 Monte Villa Parkway, Bothell, WA 98021.
BACKGROUND INFORMATION
Company is engaged in research, development, manufacturing and
commercialization of nasally administered forms of pharmaceuticals and Vendor
provides medical representatives who Detail (as hereinafter defined)
pharmaceutical products for third parties. Company expects to acquire all
manufacturing, sales and distribution rights to the Products (as defined herein)
pursuant to an Asset Purchase Agreement between the Company and Schwarz Pharma,
Inc. (the "Asset Purchase Agreement"). After the closing of the transaction
contemplated in the Asset Purchase Agreement, Company desires the Vendor to
provide representatives to Detail certain products as determined and directed by
Company in the geographical territory hereinafter specified, pursuant to the
terms and conditions of this Agreement, and Vendor desires to provide the
Syndicated Representatives (as hereinafter defined) and perform such services
pursuant to the terms and conditions set forth in this Agreement.
The parties hereby agree as follows:
ARTICLE I
DEFINITIONS AND REFERENCES TO VENDOR
1.1. Definitions. The following terms when used in this Agreement shall
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 more than fifty percent (50%) of the voting stock of the
other corporation, or (i) in the absence of the ownership of more than fifty
percent (50%) 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 use or maintaining
regulatory oversight of the Products, including, without limitation, the FDA.
{PAGE}
(d) "Commencement Date" has the meaning set forth in Section
14.1.
(e) "Detail" means an interactive, face-to-face visit by a
Syndicated 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 of the Products (as defined herein) are described by the
Syndicated 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
Syndicated Representative. When used as a verb, "Detail" or "Detailing" shall
mean to engage in a Detail as defined in this Section 1.l(e).
(f) "FDA" means the United States Food and Drug Administration
and any successor agency having substantially the same functions.
(g) "Product Launch Date" means the first Monday following
completion of the Training Program (as defined in Section 6.1).
(h) "Products" means the pharmaceutical products to be detailed
by Syndicated Representatives and marketed by Company as set forth on attached
Schedule 1.1(h) and such other products as may be mutually agreed between the
parties and added to Schedule 1.1(h) attached hereto.
(i) "Program" means the program of Detailing to be conducted by
the Syndicated Representatives pursuant to this Agreement and during the term of
this Agreement.
(j) "Promotional Materials" means all written, printed or graphic
material provided by the Company, intended for use by Syndicated Representatives
performing the Detailing, including visual aids, file cards, premium items,
clinical studies, reprints and any other promotional support items that Company
deems necessary or appropriate to conduct the Program. Promotional Materials
shall include FDA approved indicated uses, safety, effectiveness,
contraindications, side effects, warnings and other relevant characteristics
related to the Products.
(k) "Syndicated Representative" means an individual hired by and
retained as an employee of Vendor to conduct Detailing of the Product in
connection with the Program and who is shared by more than one of Vendor's
clients
(l) "Secondary Detail" means the second product discussed by the
Syndicated Representative in each Detail.
(m) "Target" or "Target Customer" means a physician or other
specialist identified by Company.
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{PAGE}
(n) "Territory" means the United States of America.
(o) "Training Program" has the meaning set forth in Section 6.1.
(p) "Vendor" means Cardinal Health Sales and Marketing Services.
ARTICLE II
APPOINTMENT OF VENDOR; GENERAL SCOPE OF ACTIVITIES
2.1. Furnishing Syndicated Representatives. Vendor shall provide fifty
(50) Syndicated Representatives to engage in Detailing and such other activities
in the Territory as directed by Company to Vendor. The duties of such Syndicated
Representatives shall be to Detail the Product as a Secondary Detail. Company
acknowledges that the Syndicated Representatives will be Detailing the Products
in addition to promoting products of other clients of Vendor. The Syndicated
Representatives shall make a minimum of thirty-six thousand (36,000) Details per
year in total.
2.2. Scope of Activities. The parties shall perform the following
activities, as applicable, in connection with the Program:
(a) Vendor shall have sole and exclusive authority to discipline
or terminate the employment of Syndicated Representatives. Company may
reasonably request that a Syndicated Representative be terminated or reassigned
if such Syndicated Representative's activities or conduct are not adequately
achieving the performance goals of the Product, or if the Syndicated
Representative fails to comply with all applicable laws, regulations, and
Company requirements for Detailing the Product. Vendor shall use its best
efforts to comply with such request; provided that such action complies with
applicable laws and is in accordance with Vendor's policies and procedures, as
determined by Vendor's human resources manager. In the event Vendor determines
that its policies and procedures or applicable laws prohibit the termination or
reassignment of any Syndicated Representative so requested by Company, it shall
notify Company of such determination and submit a corrective action plan for
Company approval.
(b) Vendor shall cause each Syndicated Representative to attend
and successfully complete the Training Program (as defined in Section 6.1)
conducted by Company for each of the Products prior to participating in the
Program. Any such Syndicated Representative who shall not successfully complete
all such requirements shall be removed and replaced by another Syndicated
Representative who shall comply with such requirements.
(c) Company shall provide Vendor, at no cost to Vendor, with
sufficient quantities of the Product Promotional Materials and Product Labeling
for the performance and supervision of Detailing. Company 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 Syndicated Representatives shall use only the
Product Labeling and the Product Promotional Materials provided by Company; and
under no
3
{PAGE}
circumstances shall Vendor or the Syndicated Representatives develop, create, or
use any other promotional material or literature for the Detailing of the
Products. Company shall advise Vendor immediately of any inaccuracy or
incompleteness of the Product Promotional Materials or the Product Labeling, and
upon such notice Vendor and the Syndicated Representatives shall immediately
cease the use of any portion or all of the Product Promotional Materials or
Product Labeling so identified by Company.
(d) Vendor shall instruct the Syndicated 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 Syndicated 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.
Syndicated Representatives shall not make any disparaging, untrue, or misleading
statements about any of Company or its Affiliates, employees, competitors, or
competing products. Syndicated 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 Syndicated Representatives shall remain under the direct
authority and control of Vendor, but shall cooperate with the members of Company
and shall receive advice and direction related to Detail activities on the
Products from Company and Vendor mutually. Company shall make all decisions with
respect to the overall strategy in connection with the Detailing of the
Products. Any Company personnel interacting with Syndicated Representatives
shall not discipline the Syndicated Representatives or implement terms or
conditions of employment or personnel policies and/or practices with respect to
the Syndicated Representatives or otherwise control the daily activities of
Syndicated Representatives. Company shall provide Vendor with copies of all
reports, memoranda, audits and other data it develops pertaining to the
Syndicated Representatives, Detailing, and the Program within fifteen (15) days
of the preparation of such documents; provided, however, that any such documents
claiming negligent or wrongful acts or omissions of Syndicated Representatives
shall, as provided in Section 2.4, be sent to Vendor as promptly as practicable.
(f) Company shall reimburse Vendor for all reasonable and
documented travel expenses of Syndicated Representatives in connection with
participation in training programs and planning meetings requested by Company
pursuant to this Agreement, including, but not limited to, airline, lodging,
meals and such other usual and customary travel expenses, at the corporate rates
available to Vendor, incurred in accordance with Vendor's expense guidelines and
processed through Vendor's expense reporting system. Such reimbursement shall
include a three and one-half percent (3.5%) administrative fee. A copy of
Vendor's Expense Guidelines is attached as Schedule 2.2(f).
(g) Syndicated Representatives shall comply with Vendor's drug
policy, a copy of which is attached hereto and incorporated herein by reference
as Schedule 2.2 (g).
4
{PAGE}
(h) Details by each Syndicated Representative will be reported to
Company on a monthly basis, in a manner agreed upon by the parties, in a paper
or electronic format.
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