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
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CO-PROMOTION AGREEMENT
BY AND BETWEEN
ASTRAZENECA PHARMACEUTICALS LP
AND
ATHEROGENICS, INC.
DATED AS OF DECEMBER 22, 2005
================================================================================
TABLE OF CONTENTS
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
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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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.
"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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"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
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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.
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"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.
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"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.
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"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.
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"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.
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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 xxxx, 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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(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.
-11-
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
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[****] 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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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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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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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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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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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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(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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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.
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[****] 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.
-19-
(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 Company's training
meetings and conduct compliance audits to ensure that the Company has complied
with its obligations pursuant to this Section 4.1.
(g) The Company shall obtain from any member of the Company Sales
Force who leaves the employ of the Company or ceases to participate in the
Program all training materials provided by the Company, and shall reuse such
materials for the replacement member of the Company Sales Force.
(h) The Company shall assign to the Company Sales Force only those
individuals who demonstrate, after the Training Program described in Section
4.1(a) or Section 4.1(b), a thorough knowledge of the Products and the Products'
associated disease entities, by achieving a minimum score at the same level
established for the AZ Sales Force [****] on a Product sales orientation
assessment test, and subsequent (refresher) tests, which tests shall be reviewed
and approved by AZ.
4.3. Conduct by Company Sales Representatives
The Company shall be legally responsible for the conduct of the
activities of its Sales Force, including compliance with the requirements of
this Agreement, Applicable Laws and the Corporate Integrity Agreement. The
Parties will work together to design and support (a) Training Programs conducted
by AZ and/or the Company to ensure such compliance; and (b) ongoing supervision
and review by the Company of the recruiting, screening, training and monitoring
of members of the Company Sales Force.
ARTICLE V.
SAMPLES
5.1. Provision of Samples
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[****] 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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AZ shall make Product samples available to the Company for use by
Company Representatives in Detailing the Products at AZ's sole cost during the
Term. Such Product samples shall be of the same quality and quantity on a per
Representative basis as the Product samples that AZ makes available to the AZ
Representatives for similarly valued specialists as described in the Strategic
Targeting Plan. The U.S. Commercialization Team shall determine sampling
strategy, including whether sample-send or sample-carry methods are utilized;
provided that any such determination shall be applied consistently with the
strategy used for the AZ Sales Force. In either case the Company and Company
Representatives shall (i) use the Information Technology to order Product
samples from AZ and to maintain accurate records of use and distribution of
Product samples; and (ii) ensure that not less than [****] (or whatever lower
amount of samples required to be provided by AZ Representatives for the Product)
are provided to Target Prescribers in accordance with the Strategic Targeting
Plan and that samples are provided to non-Target Prescribers only in such cases
the Company reasonably believes that such deliveries are likely to result in
increased sales of the Products. The Company shall comply with all requirements
of the PDMA and any other Applicable Laws in connection with the storage,
handling, transport and distribution of, and reporting requirements with respect
to, Product samples and shall maintain written procedures to ensure that all
Company Representatives so comply.
5.2. Sample-Carry
If and when AZ utilizes sample-carry sampling methods, the Company
and Company Representatives shall comply with the policies and procedures set
forth in this Section 5.2.
(a) AZ or its designated vendor shall ship Product samples directly
to Representatives. The Representatives shall secure Product samples against
theft, tampering, and diversion during storage and transport by them. The
Company shall use Commercially Diligent Efforts to ensure that Company
Representatives carry only those quantities of Product samples reasonably needed
for a specific period; provided, however, that the Company shall, at AZ's
reasonable request, audit the inventory of any Company Representative whose
supply of Product samples is materially inconsistent with such Company
Representative's need for such Product samples. In no event, however, shall any
Company Representative carry more than a five (5) day supply of samples in his
or her automobile.
(b) The Company shall, prior to distribution of any sample Product
by any Company Representative: (i) visually check the Product expiration date to
ensure that the sample has a reasonable dating period remaining; (ii) verify,
using the Promotion Policies, the Target Prescriber's or other prescriber's
identity as a practitioner authorized by Applicable Law to receive drug samples;
(iii) confirm that Product packaging is intact and includes the designation
"sample" (if required); (iv) obtain an executed sample request form or
electronic equivalent in accordance with the PDMA requirements; and
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[****] 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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(v) confirm Product identity to be accurate by visual inspection of the Product
packaging. At the time of delivery, the Company shall obtain a receipt (which
may be electronic using the Information Technology) from the Target Prescriber
or other prescriber executed in accordance with the requirements of the PDMA.
(c) The Company shall notify AZ within twenty-four (24) hours upon
learning that any Product samples have been lost or stolen or have not been
received as scheduled, or have otherwise not been handled in accordance with the
requirements of the PDMA, and shall cooperate fully with AZ in making such
investigations and reports as may be necessary under the PDMA and any other
Applicable Laws or as may otherwise be requested by AZ. The Company shall
provide AZ with monthly drug accountability reports within five (5) days after
the end of each month in accordance with the requirements of the PDMA. In
addition, the Company shall make drug accountability reports, information,
sample request and receipt and any other records pertaining to samples or
matters relating to the PDMA available to AZ within twenty-four (24) hours after
AZ's request.
(d) From time to time when required by AZ, the Company shall
"close-out" inventories of carried Product samples in accordance with procedures
determined by AZ.
(e) Upon reasonable advance notice to the Company, AZ shall be
entitled, at AZ's expense, to conduct an inspection and audit of the Company's
samples of the Products, documents, records, and procedures, to ensure
compliance with the provisions of this ARTICLE V.
5.3. Sample-Send
If and when AZ utilizes procedures to send samples directly to
prescribers, the Company shall utilize the Information Technology to enable AZ
to maintain all records with respect to Product samples required by the PDMA
(including the use of the Information Technology to obtain an electronic sample
request form in accordance with the PDMA requirements).
ARTICLE VI.
FEES
6.1. Calculation and Payment of Allowable Costs During the Funding Term
(a) Within thirty (30) days after the Approval Date, the Company
shall submit a non-binding estimate of the Allowable Costs expected to be
incurred for the portion of the remaining Calendar Year (the "Program Budget").
In all succeeding years during the Funding Term, the Company shall provide an
estimated Program Budget to AZ one hundred twenty (120) days prior to the end of
each Calendar Year during the
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Funding Term to reflect estimated costs for the next Calendar Year. All
estimated Program Budgets are subject to the approval of the U.S.
Commercialization Team.
(b) Not more than thirty (30) days prior to the beginning of each
month during the Funding Term, the Company shall provide AZ with an invoice,
using the form provided in Schedule 6.1A attached hereto, of the estimated
Allowable Costs expected to be incurred in the next succeeding month (or portion
thereof) in the Funding Term according to the Program Budget. The statement will
specify the number of Company Representatives expected to be assigned to the
Program.
(c) Not more than forty-five (45) days after the end of each
Calendar Quarter during the Funding Term, the Company shall provide AZ with a
statement, using the form provided in Schedule 6.1B attached hereto, of any
adjustments to the Allowable Costs based on the actual Allowable Costs incurred
and shall specify the extent to which they vary from those specified in the
statement provided pursuant to Section 6.1(b). The statement provided pursuant
to this Section 6.1(c) shall specify the amount of any variance, the reasons for
such variance, and a summary of the net amount overpaid or underpaid for the
Calendar Quarter based on such statement.
(d) AZ shall pay to the Company the amounts reflected on the
invoice(s) described in Section 6.1(b), and, if any statement provided to AZ
pursuant to Section 6.1(c) shows an amount due to the Company, the amounts
reflected on such invoice(s), by check or wire transfer within thirty (30) days
after receipt of such invoice(s). If any statement provided to AZ pursuant to
Section 6.1(c) shows an amount due to AZ, AZ shall be permitted to reduce such
amount against the amount due to the Company under the next invoice submitted to
AZ pursuant to Section 6.1(b). In the event that the amount due to AZ exceeds
the amount due to the Company under the next invoice, the Company shall remit to
AZ, by check or wire transfer within thirty (30) days, such excess amount.
(e) Schedule 6.1A and Schedule 6.1B shall be amended for any
adjustment of Allowable Costs to reflect any additional costs reasonably
incurred by the Company, with reasonable advance notice to the Sales Operations
Group, in order to achieve relative parity with the AZ Sales Force in
promotional effectiveness that were added by AZ for the benefit of the AZ Sales
Force but not provided by AZ for the Company's Sales Force, during the Funding
Term.
6.2. Incentive Compensation
(a) AZ and the Company shall each provide a goal-based bonus or
similar incentive payment plan for members of their respective Sales Forces to
encourage promotion of the Products. During the Funding Term, the Company shall
harmonize its incentive pay plans with those of AZ to AZ's reasonable
satisfaction to facilitate the Sales Forces working together.
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(b) The Company shall submit an invoice to AZ for all payments due
in respect of any such bonus or incentive payment promptly after any obligation
to make such payment has accrued during the Funding Term. AZ shall pay to the
Company the amounts reflected on such invoice by check or wire transfer on or
before AZ makes payments to any AZ Representatives for a comparable time period,
and in a manner that allows for consistency of the timing for the payment of the
same award by AZ for any AZ Representatives, but in any event, within thirty
(30) days after receipt of such invoice.
6.3. Detail Funding Term
On or before ninety (90) days prior to the conclusion of the Funding
Term, AZ shall complete an assessment of the value of the Company's
participation in the Program, and shall inform the Company in writing as to
whether it wishes to continue to fund the Company's activities on the same basis
as it did so during the Funding Term, or on some other basis, including on a
per-detail basis. If AZ informs the Company that it wishes to continue such
funding, the Parties shall negotiate the terms of any such arrangement in good
faith. If AZ wishes to fund on a per Detail basis, the Parties shall negotiate a
rate consistent with the then-going arm's length commercial rate per detail used
by third parties in comparable arrangements. Notwithstanding the foregoing,
neither Party shall be obligated to agree to the terms of any such arrangement.
The period during which the Parties agree to continued funding pursuant to this
Section 6.3 shall be called the "Detail Funding Term."
6.4. Audit Rights
(a) Upon reasonable advance notice to the Company, AZ shall be
entitled, at its expense, to have access to (i) the Company's internal call
reporting system, and (ii) solely through review by a third party, books and
records (including receipts, invoices and other proof of expenditures) in the
Company's possession or control as they relate to the relevant Products, in each
case for the purpose of verifying the Company's determination of Allowable
Costs, and such other matters as AZ reasonably requests relating to the
performance by the Company of its obligations under this Agreement; provided,
however, that if such audit shows charges by the Company for Allowable Costs in
excess of five percent (5%) of the total amount owed for the Calendar Year then
being audited, the Company shall pay for the reasonable fees and expenses of
such third party to perform the audit. AZ shall have the right to exercise this
audit right no more frequently than once in each twelve (12) month period,
unless AZ reasonably believes that the Company is not complying with its
obligations under this Agreement; provided, however, that the Company shall not
be required to maintain any receipts, invoices and other proof of expenditures
described in this Section 6.4(a) for more than three (3) years. Any adjustment
necessary under this section shall be made pursuant to Section 6.1(c).
(b) Should AZ discover information indicating, in its opinion, an
inaccuracy in the calculation of the number of Calls or Details, AZ shall so
notify the Company in writing thereof (and shall set out its preliminary
conclusions in reasonable
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detail). The Company shall advise AZ in writing within thirty (30) business days
of receiving such notice should the Company disagree with the determination of
AZ.
(c) If the Parties are unable to reach a mutually acceptable
resolution of any such disagreement described in Section 6.4(b) within twenty
(20) days, the disagreement shall be submitted for arbitration to a certified
public accounting firm selected by each Party's certified public accountants or
to such other Person as the Parties shall mutually agree (the "Arbitrator"). The
decision of the Arbitrator shall be final, and the losing Party shall bear all
of the costs and expenses of such arbitration, including the prevailing Party's
reasonable attorneys' fees.
(d) Upon reasonable advance notice to the Company, AZ shall be
entitled, to the extent permitted by law and the Company's privacy policies, at
its expense, to have access to the Company's books and records relating to the
Company's compliance with Applicable Laws and the Corporate Integrity Agreement.
Such books and records shall include any policies and procedures concerning
compliance with Applicable Laws, and records of any investigations and remedial
and disciplinary actions taken to address material violations of Applicable
Laws. AZ may exercise this audit right no more frequently than once in each
twelve month period, unless AZ reasonably believes that the Company is not
complying with its obligations under this Agreement; provided, however, that the
Company shall not be required to maintain any books and records described in
this Section 6.4(d) for more than three (3) years.
6.5. Amendments
In the event that AZ adds to or substitutes the Secondary Product to
be Promoted by Company hereunder, the aggregate amounts of compensation payable
under Sections 6.1 and 6.2 hereof shall not change, but the methodology of
determining such compensation may be modified as agreed by the parties in
writing and certain additional provisions of this Agreement may require mutually
agreed upon modification, including the Strategic Targeting Plan.
6.6. All Inclusive
The fees set forth in this Agreement constitute AZ's complete
obligation to pay the Company for its services under this Agreement. Except as
otherwise expressly provided in this Agreement, the Company shall be responsible
for all of its costs and expenses incurred in connection with the performance of
its obligations hereunder.
ARTICLE VII.
SALES OPERATIONS GROUP
7.1. Sales Operations Group
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(a) The U.S. Commercialization Team, within the context of a global
brand plan, shall make all decisions with respect to the strategy for the
marketing and Promotion of the Products in the United States. The Company's
input on such decisions may be provided by the Company representatives appointed
to the U.S. Commercialization Team, pursuant to the Collaboration Agreement.
Such decisions and input shall be made before and after the establishment,
pursuant to Section 7.1(b), of the Sales Operation Group.
(b) No later than sixty (60) days after delivery of the Final ARISE
Results, the Parties shall establish a Sales Operations Group, directed and
chaired by AZ and consisting of up to two (2) members from AZ and two (2)
members from the Company. The chairperson's duties shall include site selection,
logistics, agenda and facilitations. Each member of the Sales Operations Group
shall be an employee of the Party that appointed such member. A member of the
Sales Operations Group may be removed at any time, with or without cause, by the
Party that appointed such member. The Sales Operations Group, as established,
shall meet at least three times per annum.
(c) The Sales Operations Group shall meet each Calendar Trimester
and otherwise at the call of the chairperson to review, coordinate, and
implement the Promotion Plan and to discuss other issues regarding the Program.
In addition, the Sales Operations Group shall review and attempt to resolve
issues pertaining to this Agreement. AZ shall carefully consider the Company's
opinions and positions on all matters. The members of the Sales Operations Group
will use reasonable efforts to reach consensus on all decisions. If the Sales
Operations Group cannot decide any matter by consensus, such matter shall be
referred to the U.S. Commercialization Team. Any matter not resolved by the U.S.
Commercialization Team may be referred by either Party for resolution to the JMC
pursuant to the Collaboration Agreement; provided that any appeal to the JMC
shall not operate to delay or otherwise impair AZ's ability to implement any
decisions reached by AZ's designees on the Sales Operations Group, including any
disputed decisions, pending any final decision by the JMC.
7.2. Appointment of Project Managers
The Parties shall each designate a single person ("Project Manager")
through whom all significant communications (other than regulatory reporting,
which shall be governed by ARTICLE VIII hereof) shall be channeled. For the
Company, the Project Manager shall be the National Sales Manager described in
Schedule 3.4. The Project Managers appointed by each of the Parties shall (i)
function as a single point of contact in all substantive communications with the
other Party relative to the Program, (ii) coordinate all Promotion activities,
(iii) represent their respective Parties in matters pertaining to the Program,
and (iv) attend Program coordination meetings as their respective Parties'
representatives. Within forty-five (45) days after delivery by the Company of
Final ARISE Results pursuant to the Collaboration Agreement, each Party shall
notify the other in writing as to the name of the Project Manager it has so
appointed.
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Each Party may replace its Project Manager at any time, upon at least one (1)
week's prior written notice to the other Party, provided, however, that any
Project Manager chosen shall meet the criteria set forth in the profile in
Schedule 3.4.
ARTICLE VIII.
ADVERSE REACTION REPORTING
AND OTHER REGULATORY MATTERS
8.1. Regulatory Reporting
(a) AZ shall be solely responsible for making all reports,
submissions and responses to Agencies concerning the Products, including
reporting Adverse Events and Field Alerts, each in conformance with Applicable
Law; provided, however, that the Company shall have the right to make such other
reports as are necessary to comply with laws, rules, regulations and
requirements of the FDA applicable to it, at its sole expense; provided further,
that the Company shall promptly provide notice to AZ of any communications with
any Agency concerning the Products and shall, to the extent permitted by
Applicable Law, attach copies of all such communications to the notice sent
pursuant to this Section 8.1(a). In addition, AZ shall be solely responsible for
(i) taking all actions and conducting all communication with all third Persons
in respect of Products, including responding to all Product Quality Complaints
in respect thereof, including complaints related to tampering or contamination,
(ii) investigating all Product Quality Complaints, Adverse Events, and Field
Alerts in respect of Products, and (iii) any appropriate follow-up information
requests related to Adverse Event reports. The Company shall, at AZ's expense,
cooperate with all of AZ's reasonable requests and use its reasonable best
efforts to assist AZ in connection with (x) preparing any and all such reports
with Agencies, (y) preparing and disseminating all such communications with
third Persons, and (z) investigating and responding to any Product Quality
Complaint or Adverse Event related to the Products. The Company shall put in
place procedures and protocols that shall be actively managed by the Company to
ensure that all relevant information regarding the matters referred to in this
Article VIII that come to the attention of any member of the Sales Force is
promptly conveyed to the Company so that the Company can comply with its
reporting obligations hereunder.
(b) The Company shall provide notice to AZ within twenty-four (24)
hours from the time it becomes aware of an Adverse Event associated with use of
a Product (whether or not the reported effect is (i) described in the full
prescribing information or the published literature with respect to such Product
or (ii) determined to be attributable to such Product) of any information in or
coming into its, his or her possession or control concerning such Adverse Event
by contacting the AZ Information Center by telephone at [****], or such other
number as AZ may from time to time designate or by completing the Adverse Event
Report Forms provided by AZ and submitting such form to AZ (which may be
electronic forms provided via Sales InSite).
-------
[****] 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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(c) The Company shall notify AZ within twenty-four (24) hours of the
time it becomes aware of any information that might necessitate the filing by AZ
of a field alert report, as required under 21 C.F.R. Section 314.81(b)(1) (a
"Field Alert"), as such regulation may be amended from time to time, by
contacting the AZ Information Center by telephone at [****], or such other
number as AZ may from time to time designate.
(d) The Company shall notify AZ within twenty-four (24) hours of the
time it becomes aware of any Product Quality Complaint associated with use of a
Product by contacting the AZ Information Center by telephone at [****], or such
other number as AZ may from time to time designate in writing.
(e) AZ shall provide adverse drug experience information, including,
but not limited to, any of the events described in Sections 8.1(a), (b), (c) and
(d), regarding the Products to the Company to the extent such information is
provided by AZ to its representatives. AZ shall also notify the Company
immediately of any formal communication received by AZ from the FDA regarding
any threatened or pending action that may affect the safety or efficacy claims
of the Products or the continued marketing of the Products.
8.2. Threatened Agency Action
The Company shall immediately notify the AZ Regulatory Affairs
Department (with a copy to the AZ Legal Department) of any information the
Company receives regarding any threatened or pending action by an Agency that
may affect the safety or efficacy claims of the Products or the continued
marketing and Promotion of the Products. Upon receipt of any such information,
the Parties shall consult in an effort to arrive at a mutually acceptable
procedure for taking appropriate action; provided, however, that nothing herein
shall restrict AZ's ability to make a timely report of such matter to any Agency
or take other action that it deems to be appropriate or required by Applicable
Laws.
8.3. Reporting of Agency Actions
AZ shall inform the Company, the Company District Sales Managers
and/or the Company Sales Force of any information, announcements, reports,
submissions, communications, resolutions, actions, decisions or meetings
involving any Agency regarding a Product to the same extent and at the same time
and subject to the same limitations and restrictions that it so informs any AZ
District Sales Managers and/or members of the AZ Sales Force and subject to the
same limitations and restrictions.
8.4. Maintenance of Records
The Parties agree to maintain records and otherwise establish
procedures to ensure compliance with all Applicable Laws and professional
requirements that apply to the Promotion and marketing of the 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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8.5. Company Compliance Program
AZ acknowledges that the Company, consistent with good practice,
will maintain a corporate compliance program that will include a mechanism for
its employees to report, anonymously if they choose, any concerns about
potential illegal activity, and that the Company will investigate any such
reports. The Company will notify AZ of the substance of any such report that
relates to the subject of this Agreement within a reasonable time after it is
received, and before reporting any such activity to any Agency, unless the
Company concludes that doing so would violate Applicable Laws or would
compromise the Company's ability to complete an appropriate investigation. The
Company will in any case inform AZ of the result of the investigation.
ARTICLE IX.
RETURNED/RECALLED PRODUCT
9.1. Returned Product
AZ shall have the sole responsibility and right to accept any
returned Products. The Company shall not solicit the return of any Products, but
if for any reason the Company should receive any returned Products, the Company
shall promptly notify AZ. Any Product returned to the Company shall be shipped
by the Company to AZ's designated facility, with any reasonable shipping cost to
be paid by AZ through a charge back invoice. The Company may advise the customer
who made the return that the Product has been returned to AZ. The Company shall
fully complete and deliver to AZ the returned goods form provided by AZ with
respect to any returned Products.
9.2. Recalled Product
At AZ's request, the Company shall use Commercially Diligent Efforts
to assist AZ in obtaining and receiving any Product, including all samples
thereof, that has been recalled or withdrawn from the market, and AZ shall
reimburse the Company for any reasonable direct documented costs incurred by the
Company in taking such actions.
ARTICLE X.
INDEPENDENT CONTRACTOR STATUS
OF THE COMPANY AND THE SALES FORCE
10.1. Independent Contractor Status
The status of the Company under this Agreement shall be that of an
independent contractor. The Company shall not have the right to enter into any
agreements on behalf of AZ, nor shall it represent to any Person that it has any
such right or authority. The Company Sales Force shall not be, and shall not be
considered to be, "employees" or "joint employees" of AZ for any purpose. AZ
shall not be responsible for the control of any of the Company's employees. The
Company shall be solely
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responsible for determining all conditions of employment of the Company Sales
Force. The Company shall be responsible for the means, manner, mode and methods
of performing the Details hereunder, subject to the terms of this Agreement.
10.2. No AZ Benefits
(a) The Company acknowledges and agrees that none of the Company
Sales Force, nor anyone acting on its or their behalf, shall receive any
employee benefits of any kind from AZ. In addition, the Company (on behalf of
itself and the Company Sales Force and other employees, agents and contractors)
declines any offer now or hereafter made to participate in any of AZ's benefit
plans or programs.
(b) The acknowledgement and declination set forth in Section 10.2(a)
is intended to apply even if AZ is determined to be a co-employer or common law
or statutory law employer of any of the Company's employees, including the
Company Sales Force, notwithstanding the Parties' express agreement, and such
employees' written acknowledgement, to the contrary.
(c) AZ shall not maintain or procure any workers' compensation or
unemployment compensation insurance for or on behalf of the Company Sales Force.
The Company shall be solely responsible for paying all salaries, wages, benefits
and other compensation that the Company Sales Force may be entitled to receive
in connection with the performance of the services hereunder. The Company shall
likewise be liable for all taxes, excises, assessments and other charges levied
by any Agency on, or because of, the services to be provided by the Company
under the terms of this Agreement.
(d) The Company shall be responsible for (i) maintaining all
necessary personnel and payroll records for all members of the Company Sales
Force providing services pursuant to this Agreement; (ii) calculating their
wages and withhold taxes and other government mandated charges, taxes,
deductions, and contributions, if any; (iii) remitting such taxes, insurance,
deductions, contributions or charges to the appropriate government entity; (iv)
paying net wages and employee and other fringe benefits, if any, directly to
such members of the Company Sales Force; and (v) providing workers' compensation
and unemployment insurance coverage in amounts as required by law.
10.3. No Recruitment
During the Funding Term or Detail Funding Term, if any, and for a
period of one hundred eighty (180) days thereafter, the Company shall not
attempt to actively recruit or solicit any AZ employees or personnel without the
prior written consent of AZ, and AZ shall not attempt to actively recruit or
solicit any Company employees or personnel without the prior written consent of
the Company; provided that, notwithstanding the foregoing, each of the Company
and AZ shall be permitted to engage
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in general recruitment through advertisements or recruiting through head-hunters
so long as the other Party's employees and personnel are not specifically
targeted.
10.4. Services Agreement.
Prior, and as a condition, to assigning any member of the Sales
Force to provide services pursuant to this Agreement, the Company shall require
each such member of the Company Sales Force to sign a Services Agreement in or
substantially in the form attached hereto as Exhibit 10.4 and shall provide AZ
with an originally executed copy of such agreement.
ARTICLE XI.
NONCOMPETITION
11.1. Noncompetition
(a) During the Funding Term, neither the Company nor any of its
Affiliates shall, directly or indirectly, market, Promote, sell or accept orders
for the sale of any product other than the Products in the Territory, or assist
or cooperate in any way with any other Person, in connection with the marketing,
Promotion, selling or acceptance of orders for the sale of any product other
than the Products in the Territory.
(b) The Parties shall, prior to the commencement of any Detail
Funding Term, agree upon the terms upon which the Company may or may not sell
other products that might Compete with AstraZeneca products during the Detail
Funding Term; provided, however, that, unless otherwise agreed by the Parties,
the Company and its Affiliates shall be bound by provisions no less restrictive
than those contained in Section 11.1(c).
(c) [****], neither the Company nor any of its Affiliates shall,
directly or indirectly, market, Promote, sell or accept orders for the sale of
any Competing 1067 Product or any Competing Cardiovascular Product in the
Territory, or assist or cooperate in any way with any other Person in connection
with the marketing, promotion, selling or acceptance of orders for the sale of
any Competing 1067 Product or any Competing Cardiovascular Product in the
Territory.
(d) The Company acknowledges that the temporal and geographic
limitations set forth in this Section 11 are reasonable and necessary to protect
the legitimate interests of AZ and agrees not to contest such limitations in any
proceeding. The period of time during which the Company is prohibited from
engaging in certain activities pursuant to the terms of this Section 11 shall be
extended by the length of time during which the Company is in breach of any of
the terms of this Section 11 as determined by any judicial or other legally
binding proceeding.
-------
[****] 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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(e) The Company further acknowledges that the failure by the Company
to comply with any of the provisions of this Section 11 will result in
irreparable injury and continuing damage to AZ for which there will be no
adequate remedy at law and that, in the event of a failure of the Company so to
comply, AZ shall be entitled to such preliminary and permanent injunctive relief
as may be proper and necessary to ensure compliance with all the provisions of
this Section 11 without having to prove actual damages or to post a bond. AZ
shall also be entitled to an equitable accounting of all earnings, profits and
other benefits arising from any such violation, which rights shall be cumulative
and in addition to any other rights or remedies to which AZ may be entitled in
law or equity.
ARTICLE XII.
CONFIDENTIALITY
12.1. Nondisclosure Obligation
(a) Confidential Information. All Information disclosed by one Party
to the other Party hereunder, including the terms of this Agreement
("Confidential Information"), shall be maintained in confidence by the receiving
Party and shall not be disclosed to any Person who is not a Party or an
Affiliate of such Party, or used for any purpose except to exercise its rights
and perform its obligations under this Agreement without the prior written
consent of the disclosing Party, except to the extent that the receiving Party
can demonstrate by competent written evidence that such Information:
(i) is known by the receiving Party at the time of its receipt
and, not through a prior disclosure by the disclosing Party, as documented by
the receiving Party's business records;
(ii) is in the public domain other than as a result of any
breach of this Agreement by the receiving Party;
(iii) is subsequently disclosed to the receiving Party on a
non-confidential basis by a Third Party who may lawfully do so; or
(iv) is independently discovered or developed by the receiving
Party without the use of Confidential Information provided by the disclosing
Party, as documented by the receiving Party's business records.
(b) Return of Confidential Information Upon Expiration or
Termination of Agreement. Within thirty (30) days after any expiration or
termination of this Agreement, each Party shall destroy (and certify to the
other Party such destruction) or return such Confidential Information provided
by the other Party as the other Party reasonably requests be destroyed or
returned; provided, however, that (i) the foregoing obligation shall not apply
to any matter of Confidential Information otherwise provided for in this
Agreement; and (ii) each Party may retain a single copy of the Confidential
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Information in its confidential legal files for the sole purpose of ascertaining
its ongoing rights and responsibilities regarding the Confidential Information.
12.2. Permitted Disclosures
(a) Permitted Disclosure. Each Party may disclose Confidential
Information provided by the other Party without such other Party's written
consent to the extent such disclosure is reasonably necessary in the following
instances:
(i) disclosure to governmental or other regulatory agencies in
order to obtain or maintain intellectual property protection (such as
Trademarks) and to obtain, maintain or amend any Regulatory Materials regarding
a Product or satisfy any other regulatory obligation regarding a Product, but
such disclosure may be only to the extent reasonably necessary to obtain or
maintain intellectual property protection or obtain, maintain or amend such
Regulatory Materials;
(ii) complying with applicable court orders or governmental
regulations, including without limitation rules or regulations of the Securities
and Exchange Commission, or by rules of the National Association of Securities
Dealers, any securities exchange or NASDAQ; provided, however, that the
receiving Party shall first have given notice to the other Party hereto in order
to allow such Party the opportunity to seek confidential treatment of the
Confidential Information;
(iii) disclosure to consultants, agents or other Third Parties
solely to the extent required to accomplish the purposes of this Agreement;
provided however that such Third Parties agree to be bound by confidentiality
and non-use obligations at least equivalent in scope to those contained in this
Agreement.
(b) Written Agreements. Each Party shall obtain written agreements
from each of its employees and consultants who perform work pursuant to this
Agreement, which agreements shall obligate such persons to similar obligations
of confidentiality and to assign to such Party all inventions made by such
persons during the course of performing such work. Execution of the Service
Agreement shall be considered satisfaction of this obligation. Each Party will
notify the other Party promptly upon discovery of any unauthorized use or
disclosure of the Confidential Information of the other Party.
(c) Required Disclosure. If a Party is required by judicial or
administrative process to disclose Confidential Information that is subject to
the non-disclosure provisions of Section 12.1, such Party shall promptly inform
the other Party of the disclosure that is being sought in order to provide the
other Party an opportunity to challenge or limit the disclosure obligations,
provided that such Party's obligations to comply with Applicable Laws shall not
be affected by such obligations. Confidential Information that is disclosed by
judicial or administrative process shall remain otherwise subject to the
confidentiality and non-use provisions of Section 12.1, and the Party
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disclosing Confidential Information pursuant to law or court order shall take
all reasonable steps necessary, including without limitation obtaining an order
of confidentiality, to ensure the continued confidential treatment of such
Confidential Information.
12.3. Use of Name
Neither Party shall use the name of the other Party, without the
prior written approval of the other Party, for any purpose other than informing
employees who need to know about this Agreement; provided, however, that
AstraZeneca or its Affiliates may, without the Company's prior written approval,
use the Company's name on marketing materials that were developed by or under
the direction of the U.S. Commercialization Team or Global Commercialization
Team. Without limitation, these prohibitions apply to press releases, annual
reports, prospectuses, public statements, educational and scientific
conferences, Promotional Materials, governmental filings and discussions with
public officials, securities analysts, investors and the media. However, subject
to the requirements for review and approval that follow, these prohibitions
shall not apply to a disclosure of the other Party's name, which counsel to a
Party has advised is required by law or regulation or in response to requests
for a copy of this Agreement or related information by tax authorities.
12.4. Publicity Referral
Unless otherwise directed in writing by AZ, all matters that require
AZ's review or consent under this ARTICLE XII must be referred to AZ's Project
Manager for review and approval at the address set forth in Section 16.5. Unless
otherwise directed in writing by the Company, all matters that require the
Company's review or consent under this Section must be referred to the Corporate
Communications Department, at the address set forth in Section 16.5.
12.5. Publications
Pursuant to the Collaboration Agreement, the JMC (as such term is
defined in the Collaboration Agreement) shall develop procedures for review and
approval of publications related to a Product or other activities under the
Collaboration Agreement or under this Agreement, and neither Party shall permit
any publication in violation of such procedures.
ARTICLE XIII.
TRADEMARKS AND OTHER RIGHTS
13.1. Product Trademarks
(a) The Company shall Promote the Products only under the Product
Trademarks.
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(b) AstraZeneca and its Affiliates hereby grant the Company a
non-exclusive, royalty free license to use the Product Trademarks solely for
purposes of satisfying its obligations hereunder, which license shall terminate
upon the expiration or earlier termination of this Agreement for any reason.
13.2. No Ownership or Rights in the Product Trademarks
(a) Except as expressly set forth in Section 13.1, nothing in this
Agreement shall give either Party any rights, title or interest in and to any
other Trademarks that, as the case may be, are owned, licensed or maintained by
the other Party or its Affiliate. The Company acknowledges and agrees that
AstraZeneca or its Affiliates, as the case may be, are the owners of all rights,
title and interest in and to the Product Trademarks, including any form or
embodiment thereof, and the goodwill now and hereafter associated with the
Product Trademarks.
(b) Neither Party shall, or knowingly cause another Person to,
contest or dispute or otherwise impair or endanger the validity of, the
exclusive rights of any Trademark, including Product Trademarks, owned, licensed
or maintained, as the case may be, of the other Party or its Affiliates, or any
part thereof, or the registrations thereof.
13.3. Trademark Infringement
The Company shall promptly advise AZ of all cases of actual, potential or
suspected infringement of the Product Trademarks that come to the Company's
attention and shall render all assistance reasonably requested in connection
with any action taken by AstraZeneca or its Affiliates. AstraZeneca or its
Affiliates shall have sole control of such action. AZ shall be liable for
reasonable expenses and reasonable attorneys' fees incurred by the Company at
the specific written request of AstraZeneca or its Affiliates in connection with
such actions.
13.4. Other Rights
(a) The Company acknowledges and agrees that neither the Company,
nor any of its Affiliates, shall have any right, title or interest in or to the
Promotion Policies, each of which shall constitute Confidential Information and
the sole and exclusive property of AstraZeneca and its Affiliates.
(b) The Company acknowledges and agrees that all copyright and other
intellectual property rights in the Promotional Materials shall remain vested in
AstraZeneca.
ARTICLE XIV.
WARRANTIES; INDEMNITIES; INSURANCE
14.1. Representations, Warranties and Covenants
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(a) Each Party represents and warrants to the other Party as
follows: (i) it is a duly organized and validly existing corporation or limited
partnership under the laws of its jurisdiction of incorporation or formation;
(ii) it has full corporate or partnership power and authority and has taken all
corporate or partnership action necessary to enter into and perform this
Agreement; (iii) the execution and delivery of this Agreement and the
transactions contemplated herein do not violate, conflict with, or constitute a
default under its charter or similar organization document, its by-laws,
partnership agreement, or the terms or provisions of any material agreement or
other instrument to which it is a party or by which it is bound, or any order,
award, judgment or decree to which it is a party or by which it is bound; and
(iv) this Agreement is its legal, valid and binding obligation, enforceable in
accordance with the terms and conditions hereof.
(b) Each Party represents and warrants that it has not been debarred
and is not subject to debarment and that it shall not use in any capacity, in
connection with the services to be performed under this Agreement, any person
who has been debarred pursuant to Section 306 of the Act or who is the subject
of a conviction described in such section. The Company shall notify AZ in
writing immediately if it or any member of the Company Sales Force is debarred
or is the subject of a conviction described in Section 306 of the Act, or if any
action, suit, claim, investigation, or legal or administrative proceeding is
pending or, to the best of the Company's knowledge, is threatened, relating to
the debarment or conviction of the Company or any member of the Company Sales
Force.
14.2. AZ Indemnification
AZ shall indemnify the Company, its Affiliates and their respective
directors, officers, employees and agents (the "Company Indemnified Parties"),
and defend and save each of them harmless, from and against any and all claims,
lawsuits, losses, damages, liabilities, penalties, costs and expenses (including
reasonable attorneys' fees and disbursements) (collectively, "Losses") incurred
by any of them in connection with, arising from or occurring as a result of: (i)
the breach by AZ of any of its obligations under this Agreement (including this
Section 14.2); (ii) the breach or inaccuracy of any representation or warranty
made by AZ in this Agreement; and (iii) infringement or alleged infringement of
the Trademark or patent rights of any Person resulting from Promotion of the
Products by the Company in accordance with the terms hereof. Notwithstanding
anything else in this Section 14.2 to the contrary, (i) AZ shall not be
obligated to indemnify the Company for those Losses for which the Company has an
obligation to indemnify AZ pursuant to Section 14.3, as to which Losses each
Party shall indemnify the other to the extent of their respective liability for
such Losses; and (ii) AZ shall not be obligated to indemnify any Company
Indemnified Party for any Losses that arise as a result of gross negligence or
willful misconduct on the part of any Company Indemnified Party.
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14.3. Company Indemnification
The Company shall indemnify AZ, its Affiliates and their respective
directors, officers, employees and agents (the "AZ Indemnified Parties"), and
defend and save each of them harmless, from and against any and all Losses
incurred by any of them in connection with, arising from or occurring as a
result of (i) the breach by the Company of any of its obligations under this
Agreement (including this Section 14.3) or (ii) the breach or inaccuracy of any
representation or warranty made by the Company in this Agreement.
Notwithstanding anything else in this Section 14.3 to the contrary, (i) the
Company shall not be obligated to indemnify AZ for those Losses for which AZ has
an obligation to indemnify the Company pursuant to Section 14.2, as to which
Losses each Party shall indemnify the other to the extent of their respective
liability for such Losses; and (ii) the Company shall not be obligated to
indemnify any AZ Indemnified Party for any Losses that arise as a result of
gross negligence or willful misconduct on the part of any AZ Indemnified Party.
14.4. Indemnification Procedure
(a) Notice of Claim. The indemnified Party (the "Indemnified Party")
shall give the indemnifying Party (the "Indemnifying Party") prompt written
notice (an "Indemnification Claim Notice") of any Losses or discovery of facts
upon which such Indemnified Party intends to base a request for indemnification
under Section 14.2 or Section 14.3, but in no event shall the Indemnifying Party
be liable for any Losses that result from any delay in providing such notice.
Each Indemnification Claim Notice must contain a description of the claim and
the nature and amount of such Loss (to the extent that the nature and amount of
such Loss are known at such time). The Indemnified Party shall furnish promptly
to the Indemnifying Party copies of all papers and official documents received
in respect of any Losses.
(b) Third Party Claims. The obligations of an Indemnifying Party
under this ARTICLE XIV with respect to Losses arising from claims of any third
party that are subject to indemnification as provided for in Section 14.2 or
Section 14.3 (a "Third Party Claim") shall be governed by and be contingent upon
the following additional terms and conditions:
(i) Control of Defense. At its option, the Indemnifying Party
may assume the defense of any Third Party Claim by giving written notice to the
Indemnified Party within thirty (30) days after the Indemnifying Party's receipt
of an Indemnification Claim Notice. The assumption of the defense of a Third
Party Claim by the Indemnifying Party shall not be construed as an
acknowledgment that the Indemnifying Party is liable to indemnify any
Indemnified Party in respect of the Third Party Claim, nor shall it constitute a
waiver by the Indemnifying Party of any defenses it may assert against any
Indemnified Party's claim for indemnification. Upon assuming the defense of a
Third Party Claim, the Indemnifying Party may appoint as lead counsel in the
defense of the Third Party Claim any legal counsel selected by the Indemnifying
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Party which shall be reasonably acceptable to the Indemnified Party. In the
event the Indemnifying Party assumes the defense of a Third Party Claim, the
Indemnified Party shall immediately deliver to the Indemnifying Party all
original notices and documents (including court papers) received by any
Indemnified Party in connection with the Third Party Claim. Subject to clause
(ii) below, if the Indemnifying Party assumes the defense of a Third Party
Claim, the Indemnifying Party shall not be liable to the Indemnified Party for
any legal expenses subsequently incurred by such Indemnified Party in connection
with the analysis, defense or settlement of the Third Party Claim. In the event
that it is ultimately determined that the Indemnifying Party is not obligated to
indemnify, defend or hold harmless an Indemnified Party from and against the
Third Party Claim, the Indemnified Party shall reimburse the Indemnifying Party
for any and all costs and expenses (including attorneys' fees and costs of suit)
and any Losses incurred by the Indemnifying Party in its defense of the Third
Party Claim with respect to such Indemnified Party.
(ii) Right to Participate in Defense. Without limiting Section
14.4(b)(i), any Indemnified Party shall be entitled to participate in, but not
control, the defense of such Third Party Claim and to employ counsel of its
choice for such purpose; provided, however, that such employment shall be at the
Indemnified Party's own expense unless (A) the employment thereof has been
specifically authorized by the Indemnifying Party in writing, (B) the
Indemnifying Party has failed to assume the defense and employ counsel in
accordance with Section 14.4(b)(i) (in which case the Indemnified Party shall
control the defense).
(iii) Settlement. With respect to any Losses relating solely
to the payment of money damages in connection with a Third Party Claim and that
will not result in the Indemnified Party's becoming subject to injunctive or
other relief or otherwise adversely affect the business of the Indemnified Party
in any manner, and as to which the Indemnifying Party shall have acknowledged in
writing the obligation to indemnify the Indemnified Party hereunder, the
Indemnifying Party shall have the sole right to consent to the entry of any
judgment, enter into any settlement or otherwise dispose of such Loss, on such
terms as the Indemnifying Party, in its sole discretion, shall deem appropriate.
With respect to all other Losses in connection with Third Party Claims, where
the Indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 14.4(b)(i), the Indemnifying Party shall have authority
to consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss provided that it obtains the prior written consent of the
Indemnified Party (which consent shall not be unreasonably withheld or delayed).
The Indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnified Party that is reached without the
written consent of the Indemnifying Party. Regardless of whether the
Indemnifying Party chooses to defend or prosecute any Third Party Claim, no
Indemnified Party shall admit any liability with respect to, or settle,
compromise or discharge, any Third Party Claim without the prior written consent
of the Indemnifying Party (which consent shall not be unreasonably withheld or
delayed).
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(iv) Cooperation. Regardless of whether the Indemnifying Party
chooses to defend or prosecute any Third Party Claim, the Indemnified Party
shall cooperate in the defense or prosecution thereof and shall furnish such
records, information and testimony, provide such witnesses and attend such
conferences, discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith. Such cooperation shall include
access during normal business hours afforded to the Indemnifying Party to, and
reasonable retention by the Indemnified Party of, records and information that
are reasonably relevant to such Third Party Claim, and making employees and
agents available on a mutually convenient basis to provide additional
information and explanation of any material provided hereunder, and the
Indemnifying Party shall reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection therewith.
(v) Expenses. Except as provided above, the reasonable and
verifiable costs and expenses, including fees and disbursements of counsel,
incurred by the Indemnified Party in connection with any Third Party Claim shall
be reimbursed on a calendar quarter basis in arrears by the Indemnifying Party,
without prejudice to the Indemnifying Party's right to contest the Indemnified
Party's right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the
Indemnified Party.
14.5. Workers' Compensation and Liability Insurance
(a) The Company shall, at its own expense, provide and keep in full
force and effect, during any period during the Term following the Approval Date
(unless the Company elects not to Promote any Products pursuant to Section
2.1(c), in which case the Company's obligations under this Section 14.5 will
apply at all times during the Term following the Company's commencement of any
Promotion of any Products, the following kinds and minimum amounts of insurance:
(i) Workers' Compensation. Workers' compensation statutory
coverage as required by the laws of the states in which the services hereunder
are performed;
(ii) Employer's Liability. Employer's liability insurance with
a limit of [****] for bodily injury by accident per person, [****] for bodily
injury by accident, all persons and [****] bodily injury by disease policy
limit;
(iii) Automobile. Commercial automobile liability insurance
with a [****] combined single limit on vehicles owned, leased or rented by the
Company while performing services under this Agreement;
(iv) General Liability. Commercial general liability
insurance, including personal injury blanket contractual liability and broad
form property damage, with a [****] combined single limit per occurrence;
-------
[****] 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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(v) Umbrella Liability. Umbrella liability insurance in the
amount of [****] per occurrence and aggregate;
(vi) Employer Practices Insurance. Employer practices
insurance in the amount of [****] per occurrence; and
(vii) Property Insurance. Property insurance covering the
business property of the Company and others while at any unnamed location in the
amount of [****].
(b) Such policies of insurance shall be in a form acceptable to AZ
and shall stipulate that the insurance shall not be modified or canceled while
this Agreement is in effect without thirty (30) days prior written notice to AZ.
The Company shall provide AZ with proof of its compliance with this Section 14.5
within thirty (30) days after the date hereof.
ARTICLE XV.
TERMINATION RIGHTS AND CONSEQUENCES
15.1. Termination of the Agreement
This Agreement may be terminated as follows:
(a) By either Party:
(i) in the event of a material breach of this Agreement by the
other Party (other than those breaches and events described in Section 15.1(b)
and Section 15.2, which shall be governed by Section 15.1(b) and Section 15.2),
which breach if curable remains uncured sixty (60) days after written notice
thereof is given to the breaching Party, or
(ii) if the other Party shall file in any court or Agency,
pursuant to any statute or regulation of any state or country, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of that Party or of its assets, or if the
other Party proposes a written agreement of composition or extension of its
debts, or if the other Party shall be served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof, or if the other Party
shall propose or be a Party to any dissolution or liquidation, or if the other
Party shall make an assignment for the benefit of its creditors.
(b) By AZ:
(i) upon ten (10) days' prior written notice if:
-------
[****] 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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(A) the Company has failed to use Commercially
Diligent Efforts to ensure compliance by its Sales
Force with Applicable Laws or the Corporate
Integrity Agreement, as evidenced by a pattern of
failures by the Sales Force to so comply, which
failures are not promptly rectified; or
(B) the Company fails to report to AZ within three (3)
business days of when the Company learns of any
material violation by any Company Representative
of Applicable Laws, excluding any violations of
the American Medical Association Guidelines on
Gifts to Physicians from Industry and PhRMA Code
on Interactions with Healthcare Professionals, or
the Corporate Integrity Agreement; or
(C) the Company fails to report to AZ within ten (10)
business days of when the Company learns of any
material violation by any Company Representative
of any violations of the American Medical
Association Guidelines on Gifts to Physicians from
Industry or PhRMA Code on Interactions with
Healthcare Professionals; or
(D) the Company did not adequately investigate, or
take appropriate remedial or disciplinary actions
as a result of investigation, into any alleged
material violation(s) of Applicable Laws or the
Corporate Integrity Agreement.
(ii) within thirty (30) days after written notice from AZ to
the Company that a Change of Corporate Control of the Company has occurred, if
in the reasonable judgment of AZ any Person or group (as such term is defined in
the Securities Exchange Act of 1934, as amended) involved in the Change of
Corporate Control: (A) has a Competing Cardiovascular Product; or (B) is or has
within the past ten (10) years been a party to any litigation to which AZ or any
of its Affiliates is or has been an adverse party, where such litigation
threatened a material business interest of AZ; or (C) has previously committed
material violations of Applicable Law and AZ reasonably determines that such
violations are such that the Promotion of the Product by such Person or group
would be detrimental to AZ's business interests; or (D) has had a prior business
relationship with AZ or its Affiliates and AZ reasonably determines that the
conduct of such Person or group in such business relationship indicates that
Promotion of the Products by such Person or group would be detrimental to AZ's
business interests;
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(iii) upon ten (10) days' prior written notice if the FDA
causes the withdrawal from the market of or restricts the indications for the
Primary Product or there is an imposition of restrictive federal or state price
controls such that an obvious and substantial loss of sales for the Primary
Product would result.
(c) By the Company:
(i) On or before the Anticipated Approval Date, for any
reason; or
(ii) At least ninety (90) days prior to each annual
anniversary of the Approval Date, for any reason, with such termination to be
effective upon such annual anniversary.
(iii) Any termination by the Company pursuant to this Section
15.1(c) shall be in addition to the Company's right, under Section 2.1(c) to
elect to suspend the Promotion of Primary Products and any Secondary Product in
any year during the Term.
15.2. Termination of Funding Term and Detail Funding Term
AZ may terminate the Funding Term or, if applicable, the Detail Funding
Term:
(a) Following a notice of deficiency and failure to cure such
deficiency within sixty (60) days of such deficiency notice, if during two (2)
consecutive months the total number of Calls, as reported by AZ's internal call
reporting system or the Monthly Performance Reports, conducted for the Products
is at least [****] lower than the percentage required for AZ Sales
Representatives, or if compliance with the Strategic Targeting Plan, as measured
by the Targeted Delivery Score, is at least [****] lower than the percentage
required for AZ Sales Representatives;
(b) Following a notice of deficiency and failure to cure such
deficiency within sixty (60) days of such deficiency notice, if the number of
Company Representatives performing services hereunder at any time after six (6)
months after the Launch Date falls [****] below the level required by the
Strategic Targeting Plan and remains below such level for more than sixty (60)
consecutive days.
15.3. Effect of Termination
(a) If the effective date of termination of this Agreement pursuant
to Section 15.1, or the effective date of termination of the Funding Term or the
Detail Funding Term, occurs other than at the end of a month, the Company's
right to payment pursuant to ARTICLE VI (assuming it has satisfied the
applicable conditions set forth in this Agreement) shall be prorated for the
portion of the month during which the Agreement was in effect or the Funding
Term or the Detail Funding Term continued.
-------
[****] 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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(b) Upon the effective date of termination of this Agreement
pursuant to Section 15.1, the Company shall promptly cease all Promotion of the
Products and promptly discontinue the use of any Product Trademarks. The
termination of this Agreement shall be without prejudice to any rights or
obligations of the Parties that may have accrued prior to such termination, and
the provisions of Sections 8.1 (with respect to the Company's obligation to
report to AZ), 14.2, 14.3, 14.4, 14.5 and Articles IX, X, XI, XII, XIII, XV and
XVI shall survive any termination of this Agreement. Except as otherwise
expressly provided herein, termination of this Agreement in accordance with the
provisions hereof shall not limit remedies which may otherwise be available in
law or equity.
(c) Upon the effective date of expiration or termination of the
Funding Term or the Detail Funding Term pursuant to Section 15.2 or 2.1(c), the
Company shall have the right to continue to Promote the Primary Product pursuant
to Section 2.2(c), subject to and in accordance with the terms and provisions of
this Agreement.
15.4. Return of All Materials
At the end of the Term, the Company shall promptly return to AZ all
Product samples, all equipment and materials, Promotional Materials, and
training materials that AZ provided to the Company in connection with the
Program or otherwise pursuant to this Agreement in the possession of, or under
the control of, the Company or the Company Sales Force; provided the Company
shall have the right to purchase the lap top and Territory Management Devices
from AZ at their respective then fair market value.
15.5. Continuation of Promotion of Secondary Product
The Company would be permitted to continue to co-promote the
Secondary Product after the conclusion of the Funding Term only upon the mutual
agreement of the Parties.
ARTICLE XVI.
MISCELLANEOUS
16.1. Dispute Resolution
(a) Except as provided in Sections 3.1(e), 6.4, 7,1(c), 11.1 and
12.4, the Parties shall attempt in good faith to settle any Disputes by
negotiations between representatives who have decision-making authority
regarding such Dispute. Within ten (10) days after either Party gives written
notice of a Dispute to the other Party (the "Dispute Notice"), representatives
of each Party having decision-making authority regarding the Dispute (subject to
Board of Directors' or equivalent approval, if required), shall meet at a
mutually acceptable time and place, and thereafter as often as they
-43-
reasonably deem necessary, to exchange relevant information and to attempt to
resolve the Dispute.
(b) If, within thirty (30) days after the Dispute Notice, the
Parties have not resolved the Dispute, upon written request by either Party to
the other Party, the Parties shall promptly appoint a mutually acceptable
Neutral to act as a mediator. If the Parties are not able to agree on an
acceptable Neutral within forty-five (45) days after the Dispute Notice, the JMC
shall be responsible for selecting a qualified, disinterested, and conflict-free
Neutral within fifteen (15) days of being approached by either AZ or the
Company. The fees and costs of the Neutral shall be shared equally by the
Parties.
(c) The Neutral shall conduct the mediation pursuant to the rules
and procedures of JAMS applicable to evaluative mediations. The Parties shall
participate in the mediation to its conclusion; provided, however, that neither
Party shall be obligated to continue to participate in the mediation if the
Parties have not resolved the Dispute in writing within one-hundred and twenty
(120) days after the Dispute Notice and if either Party shall have terminated
the mediation by delivery of written notice of termination to the other Party
following expiration of the one-hundred and twenty (120) day period. The results
of the mediation shall not be binding upon the Parties; provided, however, that
the Parties shall give good faith consideration to the settlement of the Dispute
on the basis of such result. Notwithstanding any other provision hereof to the
contrary, if one Party does not accept such result (the "Disputing Party") and
either Party thereafter pursues any other judicial or nonjudicial remedy to
conclusion, the Disputing Party shall pay the reasonable attorneys' fees, costs,
and other expenses (including expert witness fees) of the other Party, if any,
if the result of such other remedy is not more favorable to the Disputing Party
than the result of the mediation.
(d) Nothing in this Section 16.1 shall preclude either Party from
seeking interim or provisional relief, including a temporary restraining order,
preliminary injunction or other interim equitable relief concerning a Dispute
either prior to or during the mediation if necessary to protect the interests of
such Party. This Section 16.1 shall be specifically enforceable.
(e) The Parties hereto agree that none of their respective conduct
during the course of the mediation nor any of their respective statements made
or information exchanged in connection with the mediation shall be deemed an
admission of any kind by any Party. No such conduct, statements or information
may be admitted as evidence by either Party in any other subsequent proceeding
initiated by either Party. Without limiting the foregoing, no offer of
settlement made in connection with the mediation shall be admitted as evidenced
by the Parties hereto in any other subsequent proceeding initiated by either
Party.
16.2. Governing Law
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The interpretation and construction of this Agreement, and all
matters relating hereto, shall be governed by the laws of the State of New York
applicable to agreements executed and to be performed solely within such State
excluding any conflicts or choice of law rule or principle that might otherwise
refer construction or interpretation of this Agreement to the substantive law of
another jurisdiction
16.3. Force Majeure
Neither Party shall be liable for delay in delivery or
nonperformance in whole or in part, nor shall the other Party have the right to
terminate this Agreement except as otherwise specifically provided in this
Section 16.3, where delivery or performance has been affected by a condition
beyond a Party's reasonable control, including inability to obtain labor,
materials or manufacturing facilities, provided that the Party affected by such
a condition shall, within ten (10) days of its occurrence, give notice to the
other Party stating the nature of the condition, its anticipated duration and
any action being taken to avoid or minimize its effect. The suspension of
performance shall be of no greater scope and no longer duration than is
reasonably required and the nonperforming Party shall use its best efforts to
remedy its inability to perform; provided, however, that in the event the
suspension of performance continues for 60 days after the date of the
occurrence, and such failure to perform would constitute a material breach of
this Agreement in the absence of such force majeure, the nonaffected Party may
terminate this Agreement by written notice to the other Party.
16.4. Waiver
A Party's failure to enforce, at any time or for any period of time,
any provision of this Agreement, or to exercise any right or remedy, does not
constitute a waiver of such provision, right or remedy, or prevent such Party
thereafter from enforcing any or all provisions and exercising any or all other
rights and remedies. The exercise of any right or remedy does not constitute an
election or prevent the exercise of any or all rights or remedies, all rights
and remedies being cumulative.
16.5. Notices
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Unless otherwise expressly provided for herein, all Notices shall be
in writing, shall refer specifically to this Agreement and shall be hand
delivered or sent by express courier service, costs prepaid, or by facsimile, to
the respective addresses specified below (or to such other address as may be
specified by Notice to the other Party):
If to AZ, to: AstraZeneca Pharmaceuticals LP
0000 Xxxxxxx Xxxx
Xxxxxxxxxx, Xxxxxxxx 00000
Attention: General Counsel
Telecopier No.: 302-886-1578
With a copy to: IPR Pharmaceuticals, Inc.
X.X. Xxx 0000
Xxxxxxxxx, Xxxxxx Xxxx
00000-0000
Attention: Chief Executive Officer
Telecopier No.: (000) 000-0000
If to the Company, to: AtheroGenics, Inc.
0000 Xxxxxxxx Xxxxxxx
Xxxxxxxxxx, Xxxxxxx 00000
Attn: President and Chief Executive Officer
Telecopier No.: (000) 000-0000
With a copy to: AtheroGenics, Inc.
0000 Xxxxxxxx Xxxxxxx
Xxxxxxxxxx, Xxxxxxx 00000
Attn: General Counsel
Telecopier No.: (000) 000-0000
Any Notice delivered by facsimile or similar means shall be confirmed by a hard
copy delivered as soon as practicable thereafter. The effective date of any
Notice shall be: (a) the date of the addressee's receipt, if delivered by hand
or express courier; or (b) the date of receipt if received by 5:00 p.m. local
time on a business day or, if not, the first business day after receipt, if sent
by facsimile. It is understood and agreed that this Section 16.5 is not intended
to govern the day-to-day business communications necessary between the Parties
in performing their duties, in due course, under the terms of this Agreement.
16.6. Entire Agreement
This Agreement constitutes the entire agreement between the Parties
with respect to the subject matter hereof and supersedes all prior or
contemporaneous
-46-
understandings or agreements, whether written or oral, with respect to the
subject matter hereof. Each Party confirms that it is not relying on any
representations or warranties of the other Party except as specifically set
forth herein. No amendment or modification hereof shall be binding upon the
Parties unless in writing and duly executed by authorized representatives of
both Parties.
16.7. Successors and Assigns
The terms and provisions hereof shall inure to the benefit of, and
be binding upon, AZ, the Company and their respective successors and permitted
assigns. Neither Party shall assign this Agreement without the prior written
consent of the other Party, which consent shall not be unreasonably withheld;
provided, however, that AZ shall have the right to assign or otherwise transfer
this Agreement to its Affiliates or to any successor in interest in any manner
to all or substantially all of the business to which this Agreement relates. Any
attempt to assign, transfer, subcontract or delegate any portion of this
Agreement in violation of this Section 16.7 shall be null and void.
16.8. Schedules and Exhibits
All Schedules and Exhibits referred to herein or referred to in any
other Schedule or Exhibit hereto are intended to be, and hereby are,
specifically incorporated herein and made a part of this Agreement.
16.9. Counterparts
This Agreement may be executed in one or more counterpart copies,
each of which shall be deemed an original and all of which taken together shall
be deemed to constitute one and the same instrument. It shall not be necessary
in making proof of this Agreement or any counterpart hereof to produce or
account for any of the other counterparts.
16.10. Severability
If any provision hereof should be invalid, illegal or unenforceable
in any respect, then, to the fullest extent permitted by applicable law, (a) all
other provisions hereof shall remain in full force and effect and shall be
liberally construed in order to carry out the intent of the Parties as nearly as
may be possible, and (b) the Parties shall use their best efforts to negotiate a
provision, in replacement of the provision held invalid, illegal or
unenforceable, that is consistent with applicable law and accomplishes, as
nearly as possible, the original intention of the Parties with respect thereto.
To the fullest extent permitted by applicable law, each Party hereby waives any
provision of law that would render any provision hereof prohibited or
unenforceable in any respect.
16.11. Applicable Laws
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Notwithstanding any other provision of this Agreement to the
contrary, neither Party, nor such Party's Sales Representatives, shall be
required to take any actions to Promote a Product, or any other action
contemplated by this Agreement, that would reasonably be considered to be a
violation of any Applicable Law.
16.12. Affiliates
Each Party shall cause its respective Affiliates to comply fully
with the provisions of this Agreement to the extent such provisions relate, or
are intended to relate to such Affiliates, as if such Affiliates were expressly
named as joint obligors hereunder.
Without limiting the generality of the foregoing, any obligations of
AZ may be performed by any of AZ's Affiliates, including but not limited to
AstraZeneca, and such obligations will be deemed satisfied upon performance by
such Affiliate.
16.13. Expenses
Each of the Parties shall pay the fees and expenses of its
respective counsel and other experts and all other expenses, except as otherwise
expressly set forth herein, incurred by such Party incident to the negotiation,
preparation, execution, delivery and performance of this Agreement.
16.14. Further Assurances
Each Party shall duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and do and cause to be done
such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other Party
may reasonably request to carry out more effectively the provisions and purposes
hereof, or to better assure and confirm unto such other Party its rights and
remedies under this Agreement.
16.15. Construction
The captions of this Agreement are for convenience of reference only
and in no way define, describe, extend or limit the scope or intent of this
Agreement or the intent of any provision contained in this Agreement. The
language of this Agreement shall be deemed to be the language mutually chosen by
the Parties and no rule of strict construction shall be applied against either
Party hereto.
16.16. No Joint Venture
Nothing contained in this Agreement shall be construed as creating a
partnership, joint venture or agency relationship between the Parties hereto or,
except as otherwise expressly provided herein, as granting to either Party the
authority to bind or
-48-
contract any obligation in the name of or on the account of the other Party, or
to make any statements, representations, guarantees or warranties on behalf of
the other Party.
END OF PAGE
(signatures appear on following page)
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IN WITNESS WHEREOF, the Parties have caused this Co-Promotion
Agreement to be executed by their representatives thereunto duly authorized as
of the date first set forth above.
ATHEROGENICS, INC. ASTRAZENECA PHARMACEUTICALS LP
By: /s/ XXXXXXX X. XXXXXXX By: /s/ XXXXX X. XXXXXXX
--------------------------------- --------------------
Name: Xxxxxxx X. Xxxxxxx, M.D., Ph.D. Name: Xxxxx X. Xxxxxxx
President & CEO President & CEO
SCHEDULE 1.1
AZ CARDIOVASCULAR COMPOUNDS
[****]
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[****] 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.
SCHEDULE 3.2
[****]
TO BE CREATED IN CONNECTION WITH DEVELOPMENT OF THE INITIAL STP PREPARED
PURSUANT TO SECTION 3.1
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[****] 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.
SCHEDULE 3.4
LIST OF SALES FORCE AND RELATED JOB QUALIFICATIONS
[****]
-------
[****] 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.
1
2
SCHEDULE 3.15
INFORMATION TECHNOLOGY AND COMMUNICATIONS MANAGEMENT REQUIREMENTS AND REPORTS
NOTE: THIS SCHEDULE 3.15 MAY BE AMENDED AT THE TIME OF INITIAL DEVELOPMENT OF
THE STP OR FROM TIME TO TIME THEREAFTER AS DETERMINED IN GOOD FAITH BY THE U.S.
COMMERCIALIZATION TEAM
- Voicemail Services
AZ will provide the Company with voicemail services to all members of the
Sales Force during the Funding Term. Use of voicemail will be consistent
with and subject to AZ policies and procedures for voicemail use.
- Broadband Services/High Speed Internet Access:
The Company District Managers and Representatives may be required to have
broadband/high speed internet access. If required, during the Funding
Term, AZ will provide reimbursement for the reasonable installation and
monthly service costs for broadband services consistent with reimbursement
levels provided to the AZ Sales Force.
- Support SMTP enabled mail exchange between AZ and Company.
Consistent with the AZ standard, electronic mail will be supported via
Simple Mail Transfer Protocol. The Company will use contact points within
its organization to relay E-Mails from AZ throughout the organization. The
Company will coordinate the distribution of E-Mail address lists at least
on a monthly basis.
- Additional Hardware Upgrades
Once Sales & Marketing has delivered application requirements, AZ will
analyze the current server configuration and determine whether hardware
upgrades are necessary. If additional hardware is required, AZ will
provide at AZ's sole expense during the Funding Term.
- Information Technology
(a) During the Funding Term, the Company shall use commercially
reasonable efforts to cause each Representative to use the Information
Technology to perform all record keeping, reporting, Product sample ordering,
Promotional Material ordering, and other communication functions required by AZ
in connection with the Program in accordance with procedures established from
time to time by AZ, including, without limitation:
(i) record all sales Calls and Details daily, including basic
customer profile (name, address and DEA#, where applicable), activities
(customer interaction date, type (Product Message, Service, etc.) and text
description), sample distribution (date, Product and quantity), and customer
coverage (product, owner);
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(ii) where applicable, synchronize Compass, NorthStar, and
Sales InSite each workday and at the end of the month;
(iii) where applicable, review daily the activity of his or
her AZ counterpart;
(iv) review the Strategic Targeting Plan and plan the
following business day's routing and sales Calls;
(v) update the profile of Target Prescribers when and as
appropriate;
(vi) record completion of all assigned To-Do's;
(vii) fulfill reporting requirements to District Manager; and
(viii) where applicable, communicate with Sales InSite to:
1) report Territory business activity according to
business rules of AZ (at least weekly)
2) report on sample management daily
3) order Promotional Materials as required
(b) During the Funding Term, AZ, at its expense, shall provide the
Sales Force with "Help Desk" support for the AZ supplied Information Technology
consistent with the level of support provided to AZ's own internal sales
Representatives who use similar technology. AZ shall also provide, at no cost to
the Company, configuration services, distribution and shipping of the AZ
Supplied Information Technology to the Company Sales Force. AZ shall be
responsible for and bear the cost of any and all data line installation charges,
long distance telephone charges, and data line maintenance fees incurred in
connection with use of the Information Technology.
(c) Title to and ownership of the AZ supplied Information Technology
in the possession or control of the Company Sales Force shall at all times be
vested exclusively in AZ; at no time and under no circumstance shall the Company
or any Company Representative have title to, or any right or interest in or to,
such Information Technology. The Company shall not take any action that is
inconsistent with the right, title and interest of AZ in and to the Information
Technology. The Company shall cause the Representatives to enter into any
written agreements or acknowledgments reasonably requested by AZ in respect of
the ownership and use of such Information Technology.
The Company shall cause the Sales Force to store and handle the AZ supplied
Information Technology in a secure, proper manner so as to ensure that the
Information Technology remains in good, working condition and is not lost or
stolen. The Company shall be financially responsible to and promptly reimburse
AZ for any loss or damage to such Information Technology caused by loss or
misuse from the time such Information Technology is received by the Company
until the time such Information Technology is returned to AZ. Further the
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Company shall be financially responsible to and promptly reimburse AZ for any
loss or damage to such Information Technology caused by: (i) Information
Technology not returned by a member of Company Sales Force upon expiration or
earlier termination of the Funding Term; or (ii) a level of theft of such
Information Technology greater than what can be expected within an AZ sales
force. The Company will be responsible to pay AZ for the lesser of the net book
value of the equipment or non warranty repair cost.
(d) The Company shall cause all AZ supplied Information Technology
issued to members of Company Sales Force to be returned to AZ as soon as
reasonably possible upon the termination of employment or change in Sales Force
assignment of such Company employee . The Company shall cause all (or any part)
of the Information Technology issued to the Company by AZ to be returned as soon
as reasonably possible to AZ upon termination of this Agreement or upon the
request of AZ, if the Company chooses not to purchase such equipment at the then
current market value.
(e) Only the Software and other software approved by AZ shall be
installed on or used in connection with the Hardware, and the Company shall not
install on the Hardware any other Software. The Company shall not use the AZ
Information Technology for any other purpose other than performing the Company's
obligations under this agreement. Any other use is strictly prohibited.
(f) Where applicable, and per program basis, each Representative
shall be provided with access to an Outlook e-mail account strictly for use in
connection with the services to be provided pursuant to this Agreement.
(g) The Company shall cause its Sales Force to utilize access to the
World Wide Web in a manner that is consistent with the AZ usage policy governing
such access including any broadband applications AZ may require.
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SCHEDULE 6.1A
ALLOWABLE COSTS FOR THE SALES FORCE
[****]
-------
[****] 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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SCHEDULE 6.1B
ADJUSTMENTS TO ALLOWABLE COSTS
TO BE REIMBURSED TO THE COMPANY FOR THE PRECEDING CALENDAR QUARTER
TO THE EXTENT NOT PREVIOUSLY REIMBURSED PURSUANT TO
SECTION 6.1(b) OF THE AGREEMENT
[****]
-------
[****] 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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SCHEDULE 6.3
[****]
TO BE CREATED IN CONNECTION WITH DEVELOPMENT OF THE INITIAL STP PREPARED
PURSUANT TO SECTION 3.1
-------
[****] 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.
EXHIBIT 10.4
SERVICES AGREEMENT
(COMPANY EMPLOYEE MODEL)
This Services Agreement ("Agreement") is made by and between AtheroGenics,
Inc. (the "Company") and ____________________________________ ("Employee").
WHEREAS, the Company and Employee each acknowledge that Employee is an
employee of the Company;
WHEREAS, Company has entered into a Co-Promote Agreement (the "AZ
Agreement") with AstraZeneca Pharmaceuticals LP ("AZ"); and
NOW, THEREFORE, in consideration of the premises and mutual agreements
herein contained, and other good and valuable consideration (the receipt and
sufficiency of which are hereby acknowledged), and intending to be legally bound
hereby, the parties hereto agree as follows:
1. General. The parties agree that the premises as set forth above are
incorporated within and made a part of this Agreement.
2. Confidential Information
(a) Employee acknowledges and agrees that he or she will have access
to, or become acquainted with, Confidential Information of the Company and AZ.
For the purposes of this Agreement, "Confidential Information" shall mean any
information of the Company and AZ, whether or not developed by Employee,
including but not limited to, information which relates to all ideas, designs,
methods, discoveries, improvements, products or other results of the services
provided pursuant to this Agreement and in connection with the AZ Agreement
("Services"), and trade secrets, product data and specifications, proprietary
rights, business affairs, product developments, customer information or employee
information.
(b) Employee acknowledges and agrees that the Confidential
Information constitutes valuable trade secrets of the Company and AZ. Employee
shall keep all Confidential Information in confidence and shall not, at any
time, without the Company's prior written consent, disclose or otherwise make
available, directly or indirectly, any item of Confidential Information.
Employee shall use the Confidential Information only in connection with the
performance of the Services and for no other purpose.
3. Work Product
(a) Employee agrees that all works capable of copyright protection
that are created, in part or in whole, by him or her in connection with the
Services (the "Copyright Work Product") shall be considered "works made for
hire" within the meaning of the copyright laws of the United States and that the
Company is and shall be the sole author of the Copyright Work Product, and the
sole owner of all rights therein. If any of the Copyright Work Product is
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deemed not to be a "work made for hire," then Employee hereby assigns to the
Company all worldwide rights, title and interest in and to the Copyright Work
Product.
(b) Employee further agrees that the Company shall be the sole owner
of all inventions, discoveries, concepts, ideas, methods, improvements or
results, including all patents, trade secret rights and any other proprietary
rights therein that are developed, written, conceived, reduced to practice or
made by him or her, either solely or jointly with others, in connection with the
Services (the "Other Work Product", collectively with Copyright Work Product,
the "Work Product") and hereby assigns to the Company all worldwide rights to
and title and interest in such Other Work Product.
(c) Employee agrees to assign, and cause his or her successors and
assigns to assign, to the Company all rights in and to (i) any invention
developed, written, conceived, reduced to practice or made by him or her in
connection with the Services and (ii) all applications for registration of any
patent rights in any such invention worldwide, including all United States and
foreign letters patent and United States and foreign letters patent granted upon
any invention and all extensions, renewals and reissues thereof, and all rights
to claim priority on the basis of these applications. Employee also agrees, and
shall cause his or her successors or assigns to agree, to authorize the
Commission of the United States Patent Office and the officials of any foreign
country whose duty it is to issue patents on applications to issue all letters
patent for such inventions to the Company, its successors and assignees.
(d) Employee agrees to (i) execute all documents and perform all
acts deemed necessary by the Company to evidence the Company's ownership of all
of the foregoing Work Product; and (ii) assist the Company in obtaining,
registering, maintaining and defending, at the Company's sole expense, all
patents, copyrights, trade secret rights and other proprietary rights in and to
the Work Product in any and all countries as may be determined by the Company.
(e) Employee hereby irrevocably appoints the Company as his or her
attorney-in-fact for the purpose of executing such documents in his or her name.
4. No Other Benefits. Employee acknowledges and agrees that he or she
shall not receive any employee benefits or any other compensation of any kind
from any entity other than the Company, but shall receive all compensation for
all services performed hereunder from the Company.
5. Employee Representation. Employee represents and warrants to the
Company that Employee has not been debarred and is not subject to debarment
pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act, as amended,
or is the subject of a conviction described in such section. Employee agrees to
notify the Company in writing immediately if he or she is debarred or is the
subject of a conviction described in Section 306, or if any action, suit, claim,
investigation, or legal or administrative proceeding is pending or, to the best
of Employee's knowledge, is threatened, relating to the debarment or conviction
of Employee.
[IN THE EVENT THE EMPLOYEE EXECUTING THIS AGREEMENT IS EMPLOYED BY A CONTRACT
SALES ORGANIZATION, CONFORMING CHANGES TO THIS AGREEMENT WILL BE REQUIRED,
CONSISTENT WITH THE SERVICES AGREEMENT OF AZ FOR USE WITH CONTRACT SALES
ORGANIZATIONS.]
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IN WITNESS WHEREOF, the parties have entered into this Agreement on this
____ day of ______________, ____.
ATHEROGENICS, INC.
By ____________________________________
Its:
[EMPLOYEE]
_______________________________________
[Name]
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