<PAGE>
EXHIBIT 10.36
CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS
DOCUMENT MARKED [****] HAVE BEEN REDACTED AND HAVE BEEN FILED
SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION
================================================================================
CO-PROMOTION AGREEMENT
BY AND BETWEEN
ASTRAZENECA PHARMACEUTICALS LP
AND
ATHEROGENICS, INC.
DATED AS OF DECEMBER 22, 2005
================================================================================
<PAGE>
TABLE OF CONTENTS
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ARTICLE I.
DEFINITIONS...........................................................................................
1
1.1.
Definitions........................................................................................
1
1.2.
Construction.......................................................................................
9
ARTICLE II.
ENGAGEMENT...........................................................................................
10
2.1.
Engagement of the
Company..........................................................................
10
2.2.
Company Activities During the Funding Term, the Detail Funding Term
and the Post-Funding Term......
10
ARTICLE III. PROMOTION
SERVICES..................................................................................
11
3.1.
Strategic Targeting
Plan...........................................................................
11
3.2.
Requisite
Details..................................................................................
12
3.3.
Secondary
Products.................................................................................
12
3.4.
Services Provided by the
Company...................................................................
13
3.5.
Expertise of the
Company...........................................................................
13
3.6.
Coordination with
AZ...............................................................................
14
3.7.
Account Information and
Support....................................................................
14
3.8.
Promotion
Plan.....................................................................................
14
3.9.
Promotional
Materials..............................................................................
15
3.10.
Statements
about the
Products......................................................................
15
3.11.
Requests
for Medical
Information...................................................................
15
3.12.
Compliance
with Laws and
Policies..................................................................
16
3.13.
Sales
Meetings.....................................................................................
16
3.14.
Reporting..........................................................................................
17
3.15.
Information
Technology.............................................................................
18
3.16.
Orders for
Products; Terms of
Sale.................................................................
18
ARTICLE IV. CONDUCT OF COMPANY SALES
REPRESENTATIVES.............................................................
19
4.1.
Training
Programs..................................................................................
19
4.2.
Requirements for Hiring and Conduct of the Company Sales
Force.....................................
19
4.3.
Conduct by Company Sales
Representatives...........................................................
20
ARTICLE V.
SAMPLES...............................................................................................
20
5.1.
Provision of
Samples...............................................................................
20
5.2.
Sample-Carry.......................................................................................
21
5.3.
Sample-Send........................................................................................
22
ARTICLE VI.
FEES.................................................................................................
22
6.1.
Calculation and Payment of Allowable Costs During the Funding
Term.................................
22
6.2.
Incentive
Compensation.............................................................................
23
6.3.
Detail Funding
Term................................................................................
24
6.4.
Audit
Rights.......................................................................................
24
6.5.
Amendments.........................................................................................
25
6.6.
All
Inclusive......................................................................................
25
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ARTICLE VII. SALES OPERATIONS
GROUP..............................................................................
25
7.1.
Sales Operations
Group.............................................................................
25
7.2.
Appointment of Project
Managers....................................................................
26
ARTICLE VIII. ADVERSE REACTION REPORTING AND OTHER REGULATORY
MATTERS............................................
27
8.1.
Regulatory
Reporting...............................................................................
27
8.2.
Threatened Agency
Action...........................................................................
28
8.3.
Reporting of Agency
Actions........................................................................
28
8.4.
Maintenance of
Records.............................................................................
28
8.5.
Company Compliance
Program.........................................................................
29
ARTICLE IX. RETURNED/RECALLED
PRODUCT............................................................................
29
9.1.
Returned
Product...................................................................................
29
9.2.
Recalled
Product...................................................................................
29
ARTICLE X. INDEPENDENT CONTRACTOR STATUS OF THE COMPANY AND THE
SALES FORCE......................................
29
10.1.
Independent Contractor
Status......................................................................
29
10.2.
No AZ
Benefits.....................................................................................
30
10.3.
No
Recruitment.....................................................................................
30
10.4.
Services
Agreement.................................................................................
31
ARTICLE XI.
NONCOMPETITION.......................................................................................
31
11.1.
Noncompetition.....................................................................................
31
ARTICLE XII.
CONFIDENTIALITY.....................................................................................
32
12.1.
Nondisclosure
Obligation...........................................................................
32
12.2.
Permitted
Disclosures..............................................................................
33
12.3.
Use of
Name........................................................................................
34
12.4.
Publicity
Referral.................................................................................
34
12.5.
Publications.......................................................................................
34
ARTICLE XIII. TRADEMARKS AND OTHER
RIGHTS........................................................................
34
13.1.
Product
Trademarks.................................................................................
34
13.2.
No
Ownership or Rights in the Product
Trademarks...................................................
35
13.3.
Trademark
Infringement.............................................................................
35
13.4.
Other
Rights.......................................................................................
35
ARTICLE XIV. WARRANTIES; INDEMNITIES;
INSURANCE..................................................................
35
14.1.
Representations, Warranties and
Covenants..........................................................
35
14.2.
AZ
Indemnification.................................................................................
36
14.3.
Company
Indemnification............................................................................
37
14.4.
Indemnification
Procedure..........................................................................
37
14.5.
Workers'
Compensation and Liability
Insurance......................................................
39
ARTICLE XV. TERMINATION RIGHTS AND
CONSEQUENCES..................................................................
40
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15.1.
Termination of the
Agreement.......................................................................
40
15.2.
Termination of Funding Term and Detail Funding
Term................................................
42
15.3.
Effect of
Termination..............................................................................
42
15.4.
Return of
All
Materials............................................................................
43
15.5.
Continuation of Promotion of Secondary
Product.....................................................
43
ARTICLE XVI.
MISCELLANEOUS.......................................................................................
43
16.1.
Dispute
Resolution.................................................................................
43
16.2.
Governing
Law......................................................................................
44
16.3.
Force
Majeure......................................................................................
45
16.4.
Waiver.............................................................................................
45
16.5.
Notices............................................................................................
45
16.6.
Entire
Agreement...................................................................................
46
16.7.
Successors
and
Assigns.............................................................................
47
16.8.
Schedules
and
Exhibits.............................................................................
47
16.9.
Counterparts.......................................................................................
47
16.10.
Severability.......................................................................................
47
16.11.
Applicable
Laws....................................................................................
47
16.12.
Affiliates.........................................................................................
48
16.13.
Expenses...........................................................................................
48
16.14.
Further
Assurances.................................................................................
48
16.15.
Construction.......................................................................................
48
16.16.
No
Joint
Venture...................................................................................
48
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SCHEDULES & EXHIBITS
Schedule 1.1 AZ
Cardiovascular Compounds
Schedule 3.2
SCHEDULE of Calls and Details
Schedule 3.4
LIST OF SALES FORCE AND RELATED JOB DESCRIPTIONS
Schedule 3.15
INFORMATION TECHNOLOGY AND COMMUNICATIONS
MANAGEMENT REQUIREMENTS AND REPORTS
Schedule 6.1A
ALLOWABLE COSTS
Schedule 6.1B
ADJUSTMENTS TO ALLOWABLE COSTS
Schedule 6.3
INCENTIVE COMPENSATION PLAN
Exhibit 10.4
SERVICES AGREEMENT
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<PAGE>
CO-PROMOTION AGREEMENT
This
CO-PROMOTION AGREEMENT (the "Agreement") is entered into as of
December 22, 2005, by and between ASTRAZENECA PHARMACEUTICALS LP, a
Delaware
limited partnership ("AZ"), and ATHEROGENICS, INC., a Georgia
corporation (the
"Company"). AZ and Company are sometimes referred to in this
Agreement
individually as a "Party" and collectively as the "Parties".
W I T N E S S E T H:
WHEREAS,
pursuant to the provisions of the License and Collaboration
Agreement of even date herewith between IPR Pharmaceuticals, a
corporation
organized and existing under the laws of Puerto Rico
("AstraZeneca") and the
Company (the "Collaboration Agreement"), AstraZeneca has licensed
from the
Company the right to develop, manufacture and market products
containing
AGI-1067.
WHEREAS
AstraZeneca has appointed AZ, its Affiliate, as a non-exclusive
distributor in the Territory for the promotion of AstraZeneca
products,
including those covered by the Collaboration Agreement.
WHEREAS,
AZ and Company desire to optimize sales of the Products; and
WHEREAS,
the Parties hereto agree that the Company shall be entitled to
co-promote the Products in the Territory to Target Prescribers (as
defined
herein), all on the terms and conditions set forth herein;
NOW,
THEREFORE, in consideration of the respective covenants,
representations, warranties and agreements set forth herein, and
intending to be
legally bound hereby, the Parties hereby agree as follows:
ARTICLE I.
DEFINITIONS
1.1.
Definitions
Unless
otherwise defined herein, all of the capitalized terms used in
this
Agreement shall have the respective meanings ascribed to them in
the
Collaboration Agreement. Unless specifically set forth to the
contrary herein,
the following terms shall have their indicated meanings when used
in this
Agreement:
"Act"
means the Federal Food, Drug, and Cosmetic Act, as amended, and
the
rules, regulations, guidances, guidelines and requirements of the
FDA as may be
in effect from time to time.
<PAGE>
"Adverse
Event" means the development of an undesirable medical
condition
or the deterioration of a pre-existing medical condition following
or during
exposure to a Product, whether or not considered causally related
to the
Product, the exacerbation of any pre-existing condition(s)
occurring during the
use of a Product, or any other adverse experience or adverse drug
experience
described in the FDA's Investigational New Drug safety reporting
and New Drug
Application post-marketing reporting regulations, 21 C.F.R.
Sections 312.32 and
314.80, respectively, as they may be amended from time to time. For
purposes of
this Agreement, "undesirable medical condition" shall include
symptoms (e.g.,
nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or
the abnormal
results of an investigation (e.g., laboratory findings,
electrocardiogram),
including unfavorable side effects, toxicity, injury, overdose,
sensitivity
reactions or failure of a Product to exhibit its expected
pharmacologic/biologic
effect.
"Affiliate" means, with respect to any Person, any other Person
that
directly, or indirectly through one or more intermediaries,
Controls, is
Controlled by or is under Common Control with such first
Person.
"Agency"
means any governmental or regulatory authority in the
Territory,
including the FDA.
"Agreement" has the meaning ascribed to such term in the Preamble
hereof.
"Allowable
Costs" means reasonable, necessary and verifiable out-of-pocket
costs incurred by the Company in connection with the Program that
are specified
in Schedule 6.1 hereto, as it may be amended by agreement of the
Parties from
time to time.
"Anticipated Approval Date" means the date on which the Joint
Management
Committee determines that the Primary Product is reasonably
anticipated to
receive regulatory approval to be marketed in the United
States.
"Arbitrator" has the meaning ascribed to such term in Section
6.4(c)
hereof.
"Applicable Laws" means the American Medical Association Guidelines
on
Gifts to Physicians from Industry and the PhRMA Code on
Interactions with
Healthcare Professionals, and all federal, state and local laws,
and the rules
and regulations of all Agencies, in effect from time to time
applicable to the
marketing, promotion, distribution and sale of the Products in the
Territory,
including the Act (including guidances and guidelines published by
the FDA on
its publicly available web site), PDMA, federal and state "fraud
and abuse"
statutes and regulations, including but not limited to the Medicare
and State
Health Programs Anti-Fraud and Abuse Amendments of the Social
Security Act (42
U.S.C. Section 1320a-7b(b), the "Safe Harbor Regulations" that are
found at 42
C.F.R. Section 1001.952 et seq., and consumer protection and false
claims
statutes and regulations.
"Approval
Date" means the date on which the Primary Product receives
regulatory approval to be marketed in the United States.
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<PAGE>
"AZ" has
the meaning ascribed to such term in the Preamble hereof.
"AZ
Indemnified Party" has the meaning ascribed to such term in
Section
14.3.
"AZ
Representative" means a Representative employed or contracted by AZ
to
Promote the Products.
"AZ Sales
Force" means the Sales Force and the other personnel employed
or
contracted by AZ for the Promotion of a Primary Product and any
Secondary
Product having a specialist-focused call deck, with a relative
emphasis on
cardiologists.
"Calendar
Quarter" means each of the four (4) consecutive three-month
periods ending on March 31, June 30, September 30 and December
31.
"Calendar
Trimester" or "Calendar Trimesterly" means each of the three
(3)
consecutive four-month periods ending on April 30, August 31, and
December 31.
"Calendar
Year" means each successive period of twelve (12) consecutive
calendar months commencing on January 1 and ending on December
31.
"Call"
means an interactive in-person visit to and discussion with a
medical professional with prescribing authority by a Representative
that
consists of one or more Details.
"Change of
Corporate Control" has the meaning ascribed to such term in the
Collaboration Agreement.
"Collaboration Agreement" has the meaning ascribed to such term in
the
Preamble hereof.
"Commercially Diligent Efforts" of a Party mean those efforts that
are
consistent with Applicable Laws and with industry standards and
practices
followed by pharmaceutical companies in the Promotion of their
pharmaceutical
products with a comparable potential market.
"Company"
has the meaning ascribed to such term in the Preamble hereof.
"Company
Indemnified Party" has the meaning ascribed to such term in
Section 14.2.
"Company
Representative" means a Representative employed or contracted
by
the Company.
"Company
Sales Force" means the Sales Force employed or contracted by
the
Company, which includes the Company Representatives required by
Section 3.4 and
the other personnel set forth on Schedule 3.4 (as such schedule may
be amended
from time to
-3-
<PAGE>
time by the Sales Operations Group) assigned by the Company to
implement the
Program. Schedule 3.4 also sets forth all job descriptions relating
to the
Company Sales Force. The Company Sales Force shall have a
specialist-focused
call deck with a predominant emphasis on cardiologists. The Company
shall not
make any material changes to such job descriptions unless agreed to
by the Sales
Operations Group.
"Compass"
means the Compass software used by AZ, or any successor or
compatible customer relationship management software selected by
AZ.
"Compete"
means, with respect to a pharmaceutical product, that such
product is in the same Uniform System of Classification (USC) class
as another
product, as reported by IMS or any comparable successor agency.
"Competing
Cardiovascular Product" means any pharmaceutical product that
Competes with any of the products listed on Schedule 1.1.
"Competing
1067 Product" means any pharmaceutical product that Competes
with the Primary Product.
"Control"
and, with correlative meanings, the terms "Controlled by" and
"under Common Control with," means (i) the power to direct or cause
the
direction of the management or policies of a Person, whether
through the
ownership of voting securities, by contract, resolution, regulation
or otherwise
or (ii) the ownership, directly or indirectly, of more than fifty
percent (50%)
of the voting securities or other ownership interest of a Person
(or, with
respect to a limited partnership or other similar entity, its
general partner or
controlling entity).
"Detail"
means that part of a Call during which a Representative makes a
presentation of a Product to a medical professional with
prescribing authority
such that the relevant characteristics of the Product are described
by the
Representative in a fair and balanced manner consistent with the
requirements of
this Agreement and Applicable Law and in a manner that is customary
in the
industry for the purpose of promoting a prescription pharmaceutical
product. A
sample drop shall not constitute a Detail. When used as a verb,
"Detail" means
to engage in a Detail.
"Detail
Funding Term" means the period during the Term, following the
conclusion of the Funding Term, that AZ elects to fund the
Company's activities
(if it elects to do so) pursuant to Section 6.3, unless the
Agreement is earlier
terminated pursuant to Section 15.1 or the Detail Funding Period is
terminated
pursuant to Section 15.2.
"Disclosing Party" means the party disclosing Confidential
Information.
-4-
<PAGE>
"Dispute"
means any dispute arising between the Parties in connection
with
or relating to this Agreement, the transactions contemplated hereby
or any
document or instrument delivered in connection herewith or
therewith.
"Dispute
Notice" has the meaning ascribed to such term in Section
16.1(a)
hereof.
"Disputing
Party" has the meaning ascribed to such term in Section 17.1(c)
hereof.
"District
Sales Manager" means a supervisor of Representatives assigned
to
defined regions of the Territory.
"Employment Laws" means all federal, state, or local statutes,
laws,
ordinances, regulations or guidelines relating to (a) employment
(including
Title VII of the Civil Rights Act of 1964, the Age Discrimination
in Employment
Act, the Employee Retirement Income Security Act, the
Rehabilitation Act of
1973, the Family and Medical Leave Act, the Fair Labor -Standards
Act, the
Immigration and Reform Control Act of 1986, the National Labor
Relations Act,
the Americans With Disabilities Act, and all other applicable
federal, state, or
local statutes, laws, ordinances, or regulations, (b) safety and
health
(including the Occupational Safety and Health Act of 1970), and (c)
the payment
of taxes and required taxes and payments with respect to employees
(including
the Internal Revenue Code of 1986).
"FDA"
means the United States Food and Drug Administration and any
successor agency having substantially the same functions.
"Field
Alert" has the meaning ascribed to such term in Section 8.1.
"Funding
Term" means the three (3) year period commencing on a date
between the Anticipated Approval DATE and three months after the
Launch Date of
the Primary Product, unless the Agreement is earlier terminated
pursuant to
Section 15.1 or the Funding Term is terminated pursuant to Section
15.2.
"Hardware"
means the Laptops and the Territory Management Devices.
"Hiring
Profile" means the required minimum qualifications for Company
Sales Force members, which shall not be materially different from
those
applicable to a similarly deployed AZ Sales Force, as set forth in
Schedule 3.4.
"Incentive
Compensation" means the incentive compensation, if any, payable
to the Company to compensate its Representatives, as determined in
accordance
with Schedule 6.2 hereof.
"Indemnification Claim Notice" has the meaning ascribed to such
term in
Section 14.4.
-5-
<PAGE>
"Indemnified Party" has the meaning ascribed to such term in
Section 14.4.
"Indemnifying Party" has the meaning ascribed to such term in
Section
14.4.
"Information Technology" means the Hardware and the Software.
"JMC"
means the Joint Management Committee as that term is defined in
the
Collaboration Agreement.
"Laptops"
shall mean the laptop computers, including, but not limited to,
IBM ThinkPads and any successor devices provided by AZ to the
Company in
accordance with the terms hereof for use by the Company
Representatives in
accordance with the terms hereof.
"Launch
Date" means the date following the Approval Date on which AZ
commences Promotion of the Product.
"Losses"
has the meaning ascribed to such term in Section 14.2.
"Monthly
Performance Report" has the meaning ascribed to such term in
Section 3.14.
"Neutral"
means a disinterested, conflict-free individual not affiliated
with either Party.
"NorthStar" means the NorthStar software used by AZ and made
available to
the Company to maintain a database containing, among other things,
information
regarding medical professionals Detailed by Representatives entered
via
Territory Management Devices, or any successor or compatible
software selected
by AZ.
"Notice"
means any notice, request, report, statement or other
communication to either Party.
"PDMA"
means the Prescription Drug Marketing Act of 1987, as amended,
and
the rules, regulations and guidelines promulgated thereunder and in
effect from
time to time.
"Person"
means any individual or entity, including a government or
political subdivision, department or agency of a government.
"PIR"
means a professional information request as defined in Section
3.11.
"Post-Funding Term" means the period during the Term after the
conclusion
of the Funding Term and the Detail Funding Term, if any.
-6-
<PAGE>
"Primary
Product" means any product containing the Compound as
contemplated in the Collaboration Agreement, including any
Combination Product
(as such term is used in the Collaboration Agreement).
"Product"
means all Primary Products and any Secondary Product .
"Product
Labels and Inserts" means (i) all labels and other written,
printed or graphic matter affixed to any container, packaging or
wrapper
utilized with Products, or (ii) any written material physically
accompanying
Products, including Product package inserts.
"Product
Quality Complaint" means any and all manufacturing or
packaging-related complaints related to a Product, including (i)
any complaint
involving the possible failure of a Product to meet any of the
specifications
for such Product; (ii) any dissatisfaction with the design, package
or labeling
of a Product; or (iii) any Adverse Event that may involve the
quality of the
Product, including lack of effect, infection, or request for
testing.
"Product
Trademarks" means (i) the Trademark for the Primary Product as
determined by the Global Commercialization Team pursuant to the
Collaboration
Agreement, and the registrations thereof, (ii) the Trademarks for
or relating to
any other Products and the registrations thereof, (iii) any pending
or future
Trademark registration applications relating to the Products, (iv)
any
unregistered Trademark rights relating to the Products as may exist
through use
prior to or as of the date hereof, (v) any current or future
modifications or
variants of any of the foregoing rights, and (vi) any future
Trademarks adopted
by AZ or its Affiliates for use in connection with the
Products.
"Program"
means the program of Promotion to be conducted by the Company
during the Term in accordance with the Promotion Plan, the STP and
the terms
hereof.
"Program
Budget" has the meaning ascribed to such term in Section 6.1(a)
hereof.
"Project
Manager" shall have the meaning ascribed to such term in
Section
7.2.
"Promotion" means those activities normally undertaken by a
pharmaceutical
company's sales force to implement marketing plans and strategies
aimed at
encouraging the appropriate use of a particular prescription or
other
pharmaceutical product, including detailing. When used as a verb,
"Promote"
means to engage in such activities.
"Promotion
Plan" means the annual plan (as it may be revised from time to
time) for the Territory developed pursuant to the provisions of
Section 3.8
hereof addressing, among other things, [****]
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
-7-
<PAGE>
"Promotion
Policies" means the AZ Promotion Policies provided to the
Company in writing from time to time.
"Promotional Materials" means all written, printed or graphic
material,
other than Product Labels and Inserts, all premium items, and other
materials
provided by AZ for use by Representatives during Details relating
to Products.
"Public
Announcement" means public announcements, press releases, or
advertising, recruiting and other public documents.
"Receiving
Party" means the party receiving Confidential Information.
"Representative" means a sales representative employed or
contracted by a
Party to conduct such Party's activities in connection with the
Promotion Plan
and who has been hired by such Party using its own proprietary
recruiting and
hiring standards and who satisfies the Hiring Profile.
"Sales
Force" means the full set of Representatives employed by a
Party.
"Sales
InSite" means a Web-based application that interfaces with AZ's
Microsoft Outlook software and offers Sales InSite tools that
enable
Representatives to utilize features including sample management,
promotions,
TimeTrax reporting, Submit PIR and adverse incident reporting, and
any successor
or compatible applications selected by AZ.
"Sales
Operations Group" means the group established by the Parties
pursuant to Section 7.1 hereof.
"Secondary
Product" means an AZ Affiliate product promoted by AZ, in
addition to the Primary Product, selected pursuant to the
provisions of Section
3.3 hereof.
"Services
Agreement" means the Agreement with respect to services
performed pursuant to this Agreement for AZ between the Company and
each member
of the Company Sales Force in the form attached as Exhibit 10.4
hereto.
"Software"
means Compass, NorthStar and Sales InSite, or other successor
software selected by AZ.
"Strategic
Targeting Plan" or "STP" means the plan developed and amended
from time to time in accordance with Section 3.1 that specifies, on
a Calendar
Trimester basis, Detailing strategy and obligations, [****]
"Target
Prescriber" means an office-based cardiologist or other
physician
specialist treating predominately cardiac and vascular disease with
prescribing
authority (including nurse practitioners and physician assistants
in the office
of such cardiologist with actual prescribing authority) who is
identified in
the applicable Strategic Targeting Plan.
"Targeted Delivery Score," or "TDS", means the measurement of Sales
Force's
compliance to achievement of the STP (calculated at
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
-8-
<PAGE>
the individual and team levels of the Sales Force) by examining
completion of
actual Details against the Detail assignment at a
physician-specific level.
"Term"
means the Term of the Collaboration Agreement, as defined in
the
Collaboration Agreement (including any termination of the
Collaboration
Agreement pursuant to its terms), or such shorter period as shall
conclude upon
the effective date of termination of this Agreement pursuant to
Section 15.1.
"Territory" means the United States of America.
"Territory
Management Devices" means the electronic devices to assist in
territory management, including NEC Mobil Pro's and any successor
or compatible
devices selected by AZ for use by the Representatives.
"Third
Party Claim" has the meaning ascribed to such term in Section
14.4.
"Trademark" means any trademark, trade dress, brand mark, trade
name,
brand name, corporate name, logo or business symbol.
"Training
Program" means the training program described in Section 4.1,
including written or other recorded, videotaped or Web-based
training materials,
and in-person training meetings and on-line training programs,
provided or made
accessible to the Sales Force for training purposes.
"Turnover"
means, with respect to any period, the percentage obtained by
dividing (a) the number of members of the Company Sales Force who
were employed
on the Sales Force at the beginning of such period and who were not
continuously
employed on the Sales Force during such period, by (b) the total
number of
members constituting the Sales Force at the beginning of such
period (it being
understood that a person may be employed continuously on the Sales
Force during
any period in a series of different positions on the Sales
Force).
"U.S.
Commercialization Team" means the U.S. Commercialization Team
as
that term is defined in the Collaboration Agreement.
1.2.
Construction
Unless the
context of this Agreement otherwise requires: (a) words of any
gender include each other gender; (b) words using the singular or
plural number
also include the plural or singular number, respectively; (c) the
terms
"hereof," "herein," "hereby" and derivative or similar words refer
to this
entire Agreement; (d) the terms "Article," "Section," or "Schedule"
refer to the
specified Article, Section or Schedule of this Agreement; (e) the
term "or" has,
except where otherwise indicated, the inclusive meaning represented
by the
phrase "and/or"; and (f) the term "including" or "includes" means
"including
without limitation" or "includes without limitation."
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ARTICLE II.
ENGAGEMENT
2.1.
Engagement of the Company
(a) Subject to and in accordance with the provisions of this
Agreement, AZ agrees to engage the Company for the Term to Promote
the Products
in the Territory from and after the Approval Date. Such engagement
by AZ shall
be on a nonexclusive basis, and AZ shall at all times have the
right to market
and Promote the Products in any manner and using the services of
any Person that
AZ in its sole discretion deems necessary or appropriate; provided
that AZ shall
notify the Company prior to entering into any additional Promotion
arrangements
with respect to the Products in the Territory.
(b) The Company shall commence performing its Promotion
obligations
hereunder at any time between the Anticipated Approval Date and six
(6) months
after the Approval Date, to the extent and subject to the
conditions provided in
this Agreement.
(c) On or before the Anticipated Approval Date, and not less
than
ninety (90) days prior to each annual anniversary thereafter, the
Company shall
send to AZ a written notice stating whether it wishes, during the
next
succeeding year (the "Suspension Period"), to engage in the
activities
contemplated by this Agreement. If the Company elects not to engage
in such
activities, the Funding Term and the Detail Funding Term shall for
all purposes
of this Agreement be terminated, effective upon commencement of the
Suspension
Period, and from thenceforth the Post-Funding Term shall be in
effect and
applicable for the balance of the Term. No election by the Company
to not engage
in any such activities shall prejudice its right to engage in such
activities in
succeeding years during the Post-Funding Term.
(d) The Company shall Promote the Secondary Product during the
Funding Term and such additional period as the Parties agree,
subject to the
terms and conditions of this Agreement.
(e) The Company shall have the right to Promote the Products
under
this Agreement by means of a Sales Force consisting of its own
employees or by
contracting with an independent sales force provider pursuant to an
independent
sales force agreement, which provider shall be approved by AZ,
which approval
shall not be unreasonably withheld. The provisions of this
Agreement, including
Section 4.3, shall apply to such contracted Sales Force to the same
extent as if
they were employees of the Company and any references in this
Agreement to
employees of the Company shall apply with equal force to such
contracted Sales
Force.
2.2.
Company Activities During the Funding Term, the Detail Funding
Term
and the Post-Funding Term
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<PAGE>
(a) During the Funding Term, (i) AZ shall reimburse the Company
for
the cost of its activities under this Agreement, to the extent
provided in
Section 6.1 and Section 6.2, and subject to the terms and
conditions contained
in this Agreement; and (ii) AZ shall conduct and pay for the
training activities
as described in Section 4.1(a).
(b) Unless otherwise agreed to by the Parties, during the
Detail
Funding Term, if any, (i) AZ shall reimburse the Company for the
cost of its
activities under this Agreement, to the extent provided in Section
6.3, and
subject to the terms and conditions contained in this Agreement;
and (ii) AZ
will conduct and pay for the training activities as described in
Section 4.1(a).
(c) During the Post-Funding Term, (i) the Company shall fund
its
activities under this Agreement; and (ii) the Company shall conduct
and pay for
the training activities (other than the preparation and cost of
training
materials which shall be borne solely by AZ) as described in
Section 4.1(b).
ARTICLE III.
PROMOTION SERVICES
3.1.
Strategic Targeting Plan
(a) Within one hundred twenty (120) days after delivery by the
Company to AstraZeneca of the Final ARISE Results, the U.S.
Commercialization
Team (which shall include representatives of the Company pursuant
to the
Collaboration Agreement), shall begin developing a Strategic
Targeting Plan for
the four (4) month period following the Approval Date. Such
Strategic Targeting
Plan shall be finalized no later than thirty (30) days prior to the
Anticipated
Approval Date. Any Strategic Targeting Plan [****], with a
predominant emphasis
on cardiologists, [****].
(b) Not less than thirty (30) days prior to the beginning of
each
Calendar Trimester during the Funding Term and the Detail Funding
Term, if any,
the U.S. Commercialization Team (which shall include
representatives of the
Company pursuant to the Collaboration Agreement), shall finalize an
updated
Strategic Targeting Plan for the next succeeding Calendar
Trimester.
(c) During the course of preparation of any Strategic Targeting
Plan
pursuant to Section 3.1(a) and Section 3.1(b), the Company may,
through its
representatives on the U.S. Commercialization Team, propose to AZ
revisions to a
draft Strategic Targeting Plan that the Company reasonably believes
are
appropriate, necessary or useful to permit the Company to (i)
perform its
obligations hereunder or (ii) allow the Company Sales Force to
have
opportunities comparable overall (in terms of quality and quantity
of Calls,
Details and other factors affecting Promotion) to those provided to
the AZ Sales
Force overall to Promote the Products. AZ shall consider any such
proposed
revisions in good faith, and discuss them with the Company to allow
the adoption
of a final Strategic Targeting Plan that considers the interests
and obligations
of the Parties,
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
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<PAGE>
recognizing that AstraZeneca and its Affiliates controls the
commercialization
of the Products.
(d) Once a Strategic Targeting Plan is finalized pursuant to
Section
3.1(a) and Section 3.1(b), either Party may propose amendments
thereto, and the
Parties shall, at meetings of the U.S. Commercialization Team,
discuss such
proposed amendments in good faith and in a manner consistent with
that described
in Section 3.1(c)
(e) If, in connection with any discussions between the Parties
concerning the finalization of, or update or amendment to, a
Strategic Targeting
Plan, the Parties are unable to reach agreement concerning any
matter, and if
the resolution of such matter could be reasonably expected to have
a material
adverse effect on the Company's relative ability to Promote
Products, as
compared to the similarly deployed AZ Sales Force, such matter may
be referred
by either Party to the JMC for resolution pursuant to the terms of
the
Collaboration Agreement; provided, that the appeal process set
forth in this
Section 3.1(e) shall not operate to delay or otherwise impair AZ's
ability to
implement any STP, including any disputed portions thereof, which
has been
approved by the U.S. Commercialization Team pending any final
decision by the
JMC.
3.2.
Requisite Details
The Company shall, through the Company Sales Force, provide at
least
the minimum number of Calls and Details set forth in Schedule 3.2
to the
applicable Target Prescribers in accordance with the Strategic
Targeting Plan;
provided that the Company Sales Force may provide up to [****], or
a greater or
lesser percentage if such greater or lesser percentage is provided
for the AZ
Sales Force, of the required number of Calls and Details each
Calendar Year to
non-Target Prescribers; provided that the Company believes in good
faith that
such Calls and Details to non-Target Prescribers are likely to
result in
increased sales of the Products. For each Calendar Trimester, the
Company shall
achieve a Targeting Delivery Score (currently, at least [****])
that is
consistent with the Targeting Delivery Score for the AZ Sales Force
assigned to
the same Product for the same Calendar Trimester. Otherwise, the
Company agrees
within fifteen (15) business days of receipt of the Calendar
Trimester TDS
score, to provide AZ with an explanation for the underperformance
and a
corrective action plan designed to achieve a TDS score consistent
with that of
such AZ Sales Force in the next Calendar Trimester. Compliance by
the Company
with the foregoing sentence shall be determined by AZ's internal
call reporting
system. During the Funding Term and any Detail Funding Term, the
Company shall
perform its Promotion, Call and Detail obligations hereunder
exclusively through
the Company Sales Force. There will be a subset of targeted
physicians that are
the sole responsibility of the Company for Promotion, in order for
AZ to be able
to reasonably assess the Company's performance, which subset shall
constitute
cardiologists [****].
3.3.
Secondary Products
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
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<PAGE>
The Secondary Product to be Promoted by the Company shall be
selected by AZ from the list of AZ Affiliate products set forth in
Schedule 3.3
attached hereto and disclosed to the Company within thirty (30)
days prior to
the Anticipated Approval Date. At any time during the Term, AZ
shall have the
right to substitute the Secondary Product with any other AZ
Affiliate product
appearing on Schedule 3.3; provided that AZ may not substitute any
Secondary
Product more than twice in any twelve-month period; and provided,
further, that
AZ may not substitute any Secondary Product unless it is also
substituting such
product for all or a substantial portion of AZ's own sales
Representatives who
are promoting the Primary Product.
3.4.
Services Provided by the Company
The Company shall provide Promotion services pursuant to this
Agreement through a Sales Force of up to a total of one hundred
twenty-five
(125) members consisting of Representatives, District Sales
Managers and other
members of the Sales Force (including other managers), as
determined by the
Sales Operations Group within ninety (90) days prior to the
Anticipated Approval
Date and set forth on Schedule 3.4 hereto as necessary to supervise
or support
Company Representatives in order to implement the Program (it is
currently
anticipated by AZ that the ratio of Representatives to District
Sales Managers
would be approximately 10-to-1). A copy of the Company's recruiting
and hiring
standards shall be made available to the Sales Operations Group,
and the Company
shall not make changes to such standards if the proposed changes
would
materially impact the Hiring Profile, unless agreed to by the Sales
Operations
Group. Each member of the Company Sales Force shall be properly
trained in
accordance with the terms of ARTICLE IV. The Company, where
necessary, shall
make available its Project Manager and field management personnel
to accompany
Company Representatives on Calls and to ensure completion of the
Calls
consistent with the terms of this Agreement. It is AZ's expectation
that the
Company will ensure that each of the Company's District Sales
Manager's working
time spent in the field coaching the Company's Representatives
shall be
consistent with such time spent by AZ's District Sales Managers.
The Company
shall remove or reassign from the Program any member of the Company
Sales Force
as reasonably requested by AZ. All monies paid by AZ to the Company
for
incentive compensation shall be paid out in full to all field
personnel. Based
upon monthly performance data that AZ provides the Company, the
Company shall
generate and disseminate monthly incentive reports to field
personnel. During
the Funding Term, the Company Sales Force shall be dedicated
exclusively to the
Promotion of the Products.
3.5.
Expertise of the Company
The Company shall employ its expertise, best professional
judgment,
and where applicable its working relationships with the Target
Prescribers, for
the purpose of having Company Representatives Detail the Products
consistent
with the Strategic Targeting Plan.
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<PAGE>
3.6.
Coordination with AZ
(a) Company Representatives shall remain exclusively under the
supervisory authority of the Company's field management. AZ shall
be responsible
for the dissemination of Promotional Materials to the Company
Representatives
based on information provided by the Company.
(b) Each Party's Sales Force shall provide information to their
AZ
or Company counterparts, respectively, regarding
(i) completion of activities in connection with the Program;
(ii) market, economic, regulatory and other developments that
may affect the sale of the Products in the Territory;
(iii) best selling and servicing practices of mutual benefit
to the Parties, and account knowledge, at both the regional and
national levels,
relating to the Promotion of the Products by each Sales Force,
intended to
assist in the market share growth of the Products within each
account.
(c) During the Funding and Detail Funding Term, if any, the
Company
shall permit sales management personnel of AZ to conduct annual
field
observations with the Company's Representatives in order to allow
AZ to evaluate
overall quality assurance of the Program. During the Funding Term
and the Detail
Funding Term, if any, AZ shall permit a reasonable number of the
Company's sales
management personnel to conduct annual field observations with AZ's
Sales
Representatives in order to allow the Company to learn first hand
some of AZ's
best selling and servicing practices. Each of the foregoing field
observations
shall be granted by each Party upon reasonable advance notice from
such other
Party.
3.7.
Account Information and Support
The Company shall actively participate in managed market pull
through activities and programs consistent with similar efforts by
the AZ Sales
Force in cooperation with, and in coordination with, AZ-designated
account
leaders.
3.8.
Promotion Plan
At least one hundred eighty (180) days prior to the Anticipated
Approval Date, the U.S. Commercialization Team (which shall
include
representatives of the Company pursuant to the Collaboration
Agreement) shall
prepare the initial Promotion Plan for the Products. The initial
Promotion Plan
shall cover the first three (3) years following the Approval Date,
and will be
updated annually on a calendar year basis. The Company shall,
within thirty (30)
days of receipt, determine whether the initial Promotion Plan and
any subsequent
annual update thereof is sufficient to enable the
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<PAGE>
Company to perform its obligations hereunder; provided, however,
that in no
event shall any Promotion Plan alter the obligations of either
Party under this
Agreement. If the Company reasonably concludes that the Promotion
Plan is not
sufficient, the Company shall propose to AZ amendments to such
plan. AZ shall
review such proposed amendments and shall adopt any amendments to
the Promotion
Plan that the U.S. Commercialization Team in its good faith
judgment deems
appropriate. Subject to the foregoing requirements, the U.S.
Commercialization
Team may amend and modify the Promotion Plan in any material
respect with not
less than thirty (30) days' prior written notice to the
Company.
3.9.
Promotional Materials
The Company shall determine the method and means of using the
Promotional Materials, subject to compliance with the Promotion
Plan. In
Promoting the Products, the Company shall use only Promotional
Materials
provided by AZ. The Company shall immediately cease the use of any
Promotional
Materials when instructed to do so by AZ. The Company shall use the
Promotional
Materials only for the purposes contemplated by this Agreement. The
Company
shall ensure that Promotional Materials are not changed in any way
(including by
underlining or otherwise highlighting any text or graphics or
adding any notes
thereto) by the Company or the members of the Company Sales Force.
AZ shall make
available to the Company Representatives a quantity and quality per
Company
Representative of Promotional Materials that are equivalent to
those that AZ
makes available to AZ Representatives for similarly valued
specialists, as
described in the Strategic Targeting Plan.
3.10.
Statements about the Products
The Company shall make only those statements and claims
regarding
the Products, including as to efficacy and safety, that are
consistent with the
Product Labels and Inserts and the Promotional Materials. The
Company shall not
make any untrue or misleading statements or comments about the
Products,
competitors or other products. AZ shall instruct its Sales Force
not to make any
untrue or misleading statements or comments about the Products,
competitors or
other products.
3.11.
Requests for Medical Information
(a) AZ shall have the exclusive right to respond to all questions
or
requests for information about the Products made by any medical
professionals or
any other Person to the Company or a Representative that (i)
warrant a response
beyond the understanding or knowledge of the Representative or (ii)
are beyond
the scope of the Product Labels and Inserts or other Promotional
Materials (a
"PIR").
(b) The Company shall promptly communicate to the AZ
Information
Center or Medical Resources Department all PIRs received by the
Company or
Company Representatives. AZ shall provide to the appropriate
Company
representative, within a
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<PAGE>
reasonable time after receiving or sending any such communication,
copies of
correspondence related to such PIR.
(c) In connection with the Promotion of the Products, the
Company
shall inform prescribers that they may contact the AZ Information
Center
regarding questions or requests for information about the Products
by telephone
or by completing a Medical Resource Form and faxing the completed
form directly
to AZ Medical Resources at the facsimile number provided on such
form. AZ shall
provide the Company with sufficient quantities of Medical Resource
Forms and the
Company shall provide such forms to prescribers.
3.12.
Compliance with Laws and Policies
(a) The Company shall perform all of its obligations under this
Agreement in strict compliance with (a) the Promotion Policies, (b)
Applicable
Laws, and (c) Employment Laws. Each Party shall instruct its Sales
Force not to
take any action inconsistent with this Agreement that could
jeopardize the good
will or reputation of the Products or the other Party.
(b) The Company shall be responsible for the compliance by all
personnel assigned to the Program, whether as Company employees or
independent
contractors or agents, with Business Policies and relevant
Corporate Integrity
Agreement obligations, subject to AZ's obligations relating to the
Training
Program pursuant to Section 4.1. The Company shall report on or
before thirty
(30) days after the end of each quarter to AZ all allegations it
has received
and/or investigations it has commenced with respect to the alleged
failure by a
member of the Company Sales Force to comply with the Business
Policies and
relevant Corporate Integrity Agreement and what action, if any, was
taken as a
result.
(c) AZ is a party to a Corporate Integrity Agreement entered
into
with the federal government (the "Corporate Integrity Agreement").
Company
employees performing services under this Agreement are deemed
Covered Persons
under the terms of the Corporate Integrity Agreement. The Company
employees
deemed Covered Persons in the Corporate Integrity Agreement shall
fulfill all
training obligations set forth in the Corporate Integrity Agreement
and certify
their compliance with the training obligations set forth in the
Corporate
Integrity Agreement. The Company shall screen any employees
providing services
under this Agreement to AZ against the Health and Human Services
Office of
Inspector General and Government Services Administration Websites
for excluded
persons and shall not utilize any persons determined by such screen
to be an
excluded person in connection with the services provided under this
Agreement to
AZ. AZ shall notify Company in a reasonable time following any
amendment to the
Corporate Integrity Agreement and, to the extent permitted under
Applicable Law,
shall provide Company with a copy of any such amendment.
3.13.
Sales Meetings
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<PAGE>
Each Party
shall permit a limited number of the other Party's personnel to
participate, at such other Party's cost and expense, in the portion
of any sales
meetings at which promotion and strategies relating to the Products
are
discussed, including the Party's annual sales meeting. The criteria
for
attending any such meeting shall be the same for each Party.
3.14.
Reporting
(a) AZ shall furnish the Company with an electronic report
containing Call and Detail performance of each Party's Sales Force
versus STP
data, and TDS performance, within fifteen (15) calendar days after
the end of
each month during the Funding Term and any Detail Funding Term for
the purpose
of enabling the Company to monitor and manage its performance
versus the
requirements of this Agreement.
(b) During the Funding Term and any Detail Funding Term, the
Company
shall furnish AZ with a written report containing the following
information
within fifteen (15) calendar days after the end of a particular
month, organized
and assimilated, with respect to such month (each, a "Monthly
Performance
Report"), as the case may be:
(i) a roster of the active Company Representatives and
vacancies on the Company Sales Force as of the end of such prior
month;
(ii) The utilization of field promotional dollars as expensed
back through the Company's expense system and billed back to AZ,
pursuant to
Section 6.1 during such month by district, region and nation.
(iii) The amount of time spent by the Company's District Sales
Managers in the Field coaching Representatives; and
(iv) At least thirty (30) days advance notice of face-to-face
meetings scheduled by the Company, which are expected to involve
more than ten
(10) members of the Company Sales Force and have a duration of more
than two (2)
days.
(c) The Company shall notify AZ in writing within twenty-four
(24)
hours upon the occurrence of any of the following:
(i) The Company restructures, realigns or modifies any part of
its internal corporate structure that directly supports the
Program;
(ii) The Company amends any of its sales force incentive
compensation models after they have been initially set for the
Calendar Year
with respect to the Program.
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<PAGE>
(d) The Company shall provide, on a Calendar Trimesterly basis,
a
Turnover analysis indicating Turnover by region, by position, and
by tenure.
(e) The Company shall provide such other information as may be
called for by the Promotion Plan or reasonably requested by AZ.
3.15.
Information Technology
Prior to the Anticipated Approval Date, AZ, at its expense,
shall
provide to the Company sufficient numbers of Laptops on which
Compass is
installed and Territory Management Devices on which NorthStar is
installed (with
requisite peripherals) to enable the Company to equip each
Company
Representative on the Company Sales Force with such Hardware and
Software. The
Company shall maintain and use the Information Technology in
accordance with the
policies and procedures set forth on Schedule 3.15. Until such time
as the use
of the Information Technology by the Company and Company
Representatives in
accordance with the terms hereof has been implemented fully, the
Company and
Company Representatives shall perform all recordkeeping, reporting,
Product
sample ordering, Promotional Material ordering and other
communication functions
necessary to enable the Company to perform its obligations
hereunder in a manner
reasonably determined by AZ. The Company, at its sole expense,
shall replace, or
at AZ's option, reimburse AZ for replacement of, Hardware and
Software lost,
damaged or destroyed while in the care, custody and control of the
Company or
any member of the Company Sales Force and that is not caused by
normal wear and
tear but only to the extent that such losses or damages are in
excess of AZ's
typical experience ratings for such types of losses with respect to
its internal
sales teams, as demonstrated by AZ's business records. AZ shall
also provide to
the Company whatever is reasonably necessary (in terms of software,
hardware and
other support) that is usable specifically for the purpose of
enabling the
Company to generate appropriate sales management reports and
otherwise comply
with the Company's reporting obligations under this Agreement. AZ's
obligations
to provide laptops, software, hardware and other support at its
expense shall
apply only during the Funding Term.
3.16.
Orders for Products; Terms of Sale
AZ shall have the sole responsibility and right to fill orders
with
respect to the Products. The Company shall not take orders for the
Products, but
if for any reason the Company should receive sales orders for the
Products, the
Company shall promptly forward such orders to AZ. All orders for
Products shall
be subject to AZ's acceptance, in its sole discretion. AZ may
cancel any order
for Products, or any part thereof, at any time after acceptance
without thereby
incurring any liability to the Company. AZ shall be solely
responsible for
responding to requests from physicians for individual patients who
need a
Product but are unable to afford it. Any such request received by
the Company
should originate from the patient's physician and be forwarded to
AZ for
processing in accordance with AZ's procedures. AZ shall have the
sole right and
responsibility for establishing and modifying the terms and
conditions of the
sale of the
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<PAGE>
Products, including the terms and conditions such as the price at
which the
Products shall be sold, whether the Products shall be subject to
any trade or
quantity discounts, whether any discount shall be provided for
payments on
accounts receivable, whether the Products shall be subject to
rebates, returns
and allowances or retroactive price reductions, the channels of
distribution of
the Products, and whether credit is to be granted or refused in
connection with
the sale of any Products.
ARTICLE IV.
CONDUCT OF COMPANY SALES REPRESENTATIVES
4.1. Training
Programs
(a) During the Funding Term and the Detail Funding Term, AZ
shall
provide and pay for the following training of the Sales Force:
(i) Within 30 days prior to the Anticipated Approval Date or
no later than 30 days after the hiring of any member of the
Company's Sales
Force, but in no event earlier than 60 days before Product Launch,
AZ shall, at
its own cost and expense, hold in-person meetings for each member
for the
Company's Sales Force prior to his or her commencement of Promotion
of the
Products hereunder. These meetings shall address the following
matters: [****].
(ii) Following the completion of the Training Program
described in Section 4.1(a)(i) for each member of the Company's
Sales Force, AZ
shall, at its own cost and expense, provide to each member of the
Company's
Sales Force [****] for reinforcement and refresher training with
respect to the
Program and Promotion Plan.
(b) During the Post-Funding Term, the Company shall conduct and
pay
for training of the Company's Sales Force of the same type, and at
the same
times, as is described in Section 4.1(a), except that AZ shall pay
for the
creation and provision of the training materials described in
Section 4.2(c).
4.2.
Requirements for Hiring and Conduct of the Company Sales Force
(a) The Company shall require each Company Representative to
satisfactorily complete a series of role play scenarios of a Detail
of the
Products similar to that required for the AZ Sales Force.
(b) District Sales Managers shall complete the same Training
Program
as Company Representatives, and shall be required to achieve a
minimum score at
the same level established for AZ District Sales Managers [****] on
all Product
tests. The Company shall maintain and make available to AZ upon
request records
of such test results.
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
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<PAGE>
(c) AZ shall, throughout the Term, develop and provide training
materials to support the Training Program for the Products, whether
such
Training Program is conducted by AZ during the Funding Term or the
Detail
Funding Term or by the Company during the Post-Funding Term, at
AZ's expense.
(d) Any training materials created by or at the direction of
the
Company at the Company's expense for use in the Training Program
for the
Products must be reviewed and approved by AZ prior to the Company's
use thereof
to ensure that materials properly use the Product Trademarks and
contain
accurate information about the Products; provided, however, that
the foregoing
shall not apply to the extent such training materials are
applicable to products
other than the Products.
(e) Any Training Programs conducted by AZ or the Company shall
be
consistent with the requirements of this Agreement, the Corporate
Integrity
Agreement and Applicable Laws.
(f) AZ may, at its own expense, observe the
