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Exhibit 10.23
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
MASTER SERVICES AGREEMENT
This Master Services Agreement (this "Master Agreement"), with an Effective Date
of November 17, 2000, will set forth the terms and conditions between The
Medicines Company, 0 Xxxxxx Xxx, Xxxxxxxxxx XX 00000 (hereinafter "TMC"), and
Innovex LP, 00 Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxxx, XX 00000 (hereinafter
"Innovex").
BACKGROUND:
A. TMC is in the business of developing, manufacturing and/or distributing
pharmaceutical and/or biotechnology products ("TMC Product(s)"). Innovex is in
the business of providing sales, marketing and alternative commercialization
services for the pharmaceutical, healthcare and biotechnology industries.
B. TMC and Innovex desire to enter into this Master Agreement to provide
the terms and conditions upon which TMC may engage Innovex and its corporate
Affiliates from time-to-time to provide contract sales, marketing and
commercialization services for individual projects by executing individual Work
Orders (as defined below) specifying the details of the services and the related
terms and conditions.
AGREEMENT:
1.0 DEFINITIONS
1.1 "Affiliate" shall mean any corporation or business entity controlled
by, controlling, or under common control with a party to this
Agreement. For this purpose, "control" shall mean direct or indirect
beneficial ownership of at least fifty percent (50%) of the voting
stock or income interest in such corporation or other business entity,
or such other relationship as, in fact, constitutes actual control.
1.2 "FDA" shall mean the US Food and Drug Administration.
1.3 "Fees" shall mean the fair market value compensation payable to
Innovex in return for Services. Fees shall not include Pass-Through
Expenses.
1.4 "Pass-Through Expenses" shall mean the reasonable and necessary
out-of-pocket costs and expenses actually incurred by Innovex in
providing Services, in accordance with a mutually agreed written
budget or the express terms of a Work Order.
1.5 "Project" shall mean the complete task or set of tasks described in a
specific Work Order.
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1.6 "Services" shall mean the responsibilities, obligations and activities
that are to be performed by Innovex, as they are described in this
Agreement and in specific Work Orders.
1.7 "Term" and "Project Term" shall have the meanings described in Section
11.1.
1.8 "Work Order" shall have the meaning described in Section 2.2.
2. SCOPE OF THE AGREEMENT; SERVICES TO BE PROVIDED; WORK ORDERS; PROJECT
TEAMS.
2.1 SCOPE OF AGREEMENT. This Master Agreement allows the parties to contract
for multiple Projects through the issuance of multiple Work Orders. This
Master Agreement covers the provision of professional sales and marketing
services by Innovex and Innovex's corporate Affiliates (see Section 11),
including, but not limited to, recruitment of sales personnel, full-time or
flex-time sales force services, promotional education programs and other
related commercialization services, when requested by TMC and agreed to by
Innovex as set forth in the relevant Work Order. TMC shall, in its sole
discretion, determine when and whether to offer projects to Innovex and its
corporate Affiliates, including the decision whether or not to enter into a
specific Work Order.
2.2 Work Orders. The specific details and tasks of each Project shall be
separately negotiated and specified in writing on terms and in a form
acceptable to the parties (each such writing, a "Work Order"). Work Order
templates are provided with Appendix I. Each Work Order will include, as
appropriate, identification of the TMC Products to be involved in the
Services, a schedule of Innovex Responsibilities and Obligations, TMC
Responsibilities and Obligations and Fees and Pass-Through Expenses. Each
Work Order shall be subject to all of the terms and conditions of this
Master Agreement, in addition to the specific details set forth in the Work
Order. To the extent any terms or provisions of a Work Order conflict with
the terms and provisions of this Master Agreement, the terms and provisions
of this Master Agreement shall control, unless the Work Order expressly and
specifically states an intent to supersede the Master Agreement on a
specific matter (but then only with respect to the particular Work Order
and with respect only to the matter so specified). A change in a Work Order
shall be evidenced by an amendment to the relevant Work Order duly executed
by TMC and Innovex in form acceptable to both parties.
3. PAYMENT OF FEES AND PASS-THROUGH EXPENSES.
3.1 TMC shall pay Innovex the Fees and Pass-Through Expenses expressly
described in each Work Order. Unless otherwise agreed in a particular Work
Order, Innovex will invoice TMC monthly for the Fees and Pass-Through
Expenses relating to the Project. Each invoice shall be supported by a
detailed expense report. Supporting documentation and any any further
explanation reasonably requested by TMC will be made available to TMC upon
request. TMC shall make payment within thirty (30) days after the receipt
of each monthly itemized invoice
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unless TMC disputes such invoice in good faith. If any portion of an
invoice is disputed, TMC shall pay the undisputed amounts within the
aforementioned thirty (30) days, and the parties shall use good faith
efforts to reconcile the disputed amount for payment as soon as
practicable.
4. CONFIDENTIALITY AND OWNERSHIP OF INFORMATION.
4.1 Each of the parties acknowledges that, in the course of performing its
obligations hereunder, it may receive information from the other party
which is proprietary to the disclosing party and which the disclosing party
wishes to protect from public disclosure ("Confidential Information").
Innovex and TMC agree to retain in confidence, during the Term of this
Agreement and any Work Order, and any subsequent renewals thereof, and
thereafter for a period of five (5) years, all Confidential Information
disclosed to it by or on behalf of the other party, and that it will not,
without the written consent of such other party, use Confidential
Information for any purpose other than the purposes indicated herein or in
the applicable Work Order. These restrictions shall not apply to
Confidential Information which: (i) is or becomes public knowledge (through
no wrongful act of the receiving party); (ii) is made lawfully available to
the receiving party by an independent third party having no obligation of
confidentiality with respect to the Confidential Information; (iii) is
already in the receiving party's possession at the time of receipt from the
disclosing party (and such prior possession can be properly demonstrated by
the receiving party); (iv) is independently developed by the receiving
party and/or Affiliates without reference to reliance upon the Confidential
Information (and such independent development can be properly demonstrated
by the receiving party); or (v) is required by law, regulation, rule, act
or order of any governmental authority or agency to be disclosed by the
receiving party (including compliance with the disclosure obligations of
the SEC or the NASDAQ National Market), provided, however, if reasonably
possible, such receiving party gives the disclosing party sufficient
advance written notice to permit it to seek a protective order or other
similar order with respect to such Confidential Information and,
thereafter, the receiving party discloses only the minimum Confidential
Information required to be disclosed in order to comply. The parties
acknowledge and agree that the terms of this Agreement and Work Order shall
be Confidential Information hereunder.
4.2 Innovex and TMC shall limit disclosure of the other party's Confidential
Information to only those of their respective officers, representatives,
agents and employees (collectively "Agents") who are directly concerned
with the performance of this Agreement and have a legitimate need to know
such Confidential Information, are bound to maintain the confidentiality of
the Confidential Information and are informed of the confidential nature of
the Confidential Information. Each party shall be liable for any breach of
section 4.1 by their respective Agents. Upon receipt of notice of
termination by TMC or otherwise upon the request of TMC, Innovex shall
return all TMC Confidential Information to TMC.
4.3 All TMC patents, trade secrets, copyrights, trade names, trademarks,
service marks, proprietary materials or intellectual property and all
improvements to any of the foregoing (collectively "TMC Property") used in
connection with the Services provided pursuant to this
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Master Agreement or any Work Order shall remain the sole and exclusive
property of TMC, and Innovex's rights to use such TMC Property shall be
limited to those permitted by this Master Agreement or any Work Order.
4.4 TMC acknowledges that Innovex possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties and
other assets, including but not limited to analytical methods, procedures
and techniques, computer technical expertise and software, and business
practices, including, but not limited to the Innovex Territory Management
System (ITMS), which have been independently developed by Innovex
(collectively "Innovex Property"). TMC and Innovex agree that any Innovex
Property or improvements thereto which are used, improved, modified or
developed solely by Innovex under or during the term of this Master
Agreement or any Work Order are the sole and exclusive property of Innovex.
5. INDEPENDENT CONTRACTOR RELATIONSHIP.
5.1 For the purposes of this Master Agreement and any Work Order, the parties
hereto are independent contractors and nothing contained in this Master
Agreement or any Work Order shall be construed to place them in the
relationship of partners, principal and agent, employer and employee or
joint venturers. Neither party shall have the power or right to bind or
obligate the other party, nor shall either party hold itself out as having
such authority.
5.2 No provision of this Master Agreement or any Work Order shall be deemed to
create or imply any contract of employment between TMC and any employee of
Innovex. All persons performing Services shall be employees of Innovex, or
subcontractors engaged by Innovex with prior consent of TMC, and shall not
be entitled to any benefits applicable to employees of TMC.
5.3 Innovex will (i) maintain all necessary personnel and payroll records for
Innovex employees; (ii) compute wages and withhold applicable Federal,
State and local taxes and Federal FICA payments for Innovex employees;
(iii) remit Innovex employee withholdings to the proper governmental
authorities and make employer contributions for Federal FICA and Federal
and State unemployment insurance payments; (iv) pay net wages and fringe
benefits, if any, directly to Innovex employees; and (v) provide for
employer's liability and Workers' Compensation insurance coverage, and (vi)
otherwise comply with all applicable laws in the performance of the
Services.
5.4 Innovex shall be responsible for management of all employer obligations in
connection with Innovex employees who perform the Services. Innovex
employees shall remain exclusively under the direct authority and control
of Innovex. TMC may be involved in providing training, direction or
equipment to an Innovex employee only in the manner and to the extent
specifically described in a Work Order. The employer obligations of Innovex
shall include: (i) human resource issues, including establishment of
employee policies, and administration of health and benefits plans, 401K
plan, and other employee benefit plans; (ii) work performance and work
behavior issues, including probationary period, periodic and annual
appraisals, employee discipline and termination; (iii)
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administration of systems for time-keeping, payroll and employee expense
reimbursement; (iv) day to day management of employment issues in
connection with performance of the Services.
6. REGULATORY COMPLIANCE.
6.1 In carrying out their responsibilities under this Master Agreement and each
Work Order, Innovex and TMC agree to comply, to the extent applicable, with
all laws, rules and regulations, including, but not limited to the Federal
Equal Employment Opportunity Act, Title VII of the Civil Rights Act of
1964, the Age Discrimination in Employment Act, the Americans with
Disabilities Act, the Fair Labor Standards Act, the Immigration Reform and
Control Act of 1986, the Food, Drug and Cosmetic Act, Section 1128B(b) of
the Social Security Act (42 U.S.C. ss.1320a-7b(b)), and the Prescription
Drug Marketing Act.
6.2 If Innovex Personnel or other agents of Innovex become aware of any adverse
drug experience reports or product complaints involving the use of any TMC
Product, whether or not related to a TMC Product as to which Innovex is
performing Services under this Agreement, they shall, within twenty-four
(24) hours, inform TMC in accordance with TMC procedures. When TMC
communicates information concerning adverse drug experience reports in a
"Dear Doctor" letter to physicians, such information shall be communicated
to Innovex and Innovex Personnel. All customer inquires or complaints shall
be forwarded to TMC for response; Innovex shall not respond on behalf of
TMC. Innovex shall bring all adverse drug event reports, product complaints
or inquiries to the attention of TMC Medical Information Department by
utilizing the form set forth in Exhibit A to the Master Service Agreement
and faxing such information to (000) 000-0000. For faster response or to
directly report an adverse event Innovex shall call the Medical Information
Department at (800) - ANGIOMAX.
6.3 TMC shall be solely responsible for responding to any government or
regulatory agency concerning use or marketing of TMC Products, except where
(i) such responsibility is expressly transferred to Innovex in a Work
Order; or (ii) to the extent any notice or reporting requirement is by law
made directly applicable to Innovex. Innovex shall promptly notify TMC of
any information Innovex receives regarding any threatened or pending action
by a government or regulatory agency that may affect the TMC Products.
Innovex shall, at the request of TMC, cooperate with TMC in order to
respond, or in formulating a procedure for taking appropriate action. In no
event shall Innovex respond to any agency without the prior consent of TMC,
unless compelled to do so by law.
6.4 CONDUCT OF THE SALES FORCE. In accordance with the terms and conditions of
this Agreement, and subject to any and all applicable laws and regulations,
Innovex shall use commercially reasonable efforts to direct its Innovex
Sales Force to market and promote the Product to the [Target doctors],
through the delivery of Details. Innovex represents and warrants that the
members of the Innovex Sales Force will make no statements, claims or
undertakings to any person with whom they discuss or promote the Products
that are not consistent with, nor provide or use any labeling, literature,
samples or other materials other than, those Promotional Materials and
samples provided and currently approved for use by TMC. If at
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any time TMC notifies Innovex in writing that it no longer approves the use
of specified Promotional Materials, Innovex shall immediately take action
to remove the Promotional Materials from use by the Innovex Sales Force
and, at TMC's request and expense, either destroy such materials or return
them to TMC. No member of the Innovex Sales Force shall make any
representation, statement, warranty or guaranty with respect to the Product
that is not consistent with the applicable, current package insert of
prescribing information or other documentation accompanying or describing
the Product, including TMCs standard limiting warranty and disclaimers, if
any.
7. REPORTS AND PROJECT ADMINISTRATION
Innovex will manage and administer each Project in accordance with the
specifications and milestones contained in each Work Order. Innovex shall
provide TMC a periodic Project report, in the frequency and with content as
more particularly described in each Work Order. The Project report shall
generally include: (i) headcount, turnover, status of recruitment; (ii)
Project status and progress toward achieving objectives or milestones;
(iii) financial accountability, and tracking expenses against budget.
8. RETURN OF TMC MATERIALS.
Within thirty (30) days after the completion of Services by Innovex, or
upon termination of the Master Agreement or any Work Order or at any time
at the request of TMC, Confidential Information, TMC Property marketing
materials for TMC Products, and other data owned by TMC, regardless of the
method of storage or retrieval, shall at TMC's request either be delivered
to TMC in such form as is then currently in the possession of Innovex, or
disposed of, at the direction and written request of TMC, unless such
materials are otherwise required to be stored or maintained by Innovex as a
matter of law or regulation. TMC shall pay the reasonable costs associated
with any of the above options. Innovex reserves the right to retain, at its
own expense and subject to the confidentiality provisions herein, one copy
of all materials provided in connection with performance of the Services
for archival purposes only, to be used to satisfy regulatory requirements
or to resolve disputes regarding the Services.
9. INDEMNIFICATION AND LIABILITY LIMITS.
9.1 Innovex shall indemnify, defend and hold harmless TMC, its Affiliates and
its and their respective directors, officers, employees and agents from and
against any and all losses, claims, actions, damages, liabilities,
penalties, costs and expenses (including reasonable attorneys' fees and
court costs) (collectively, "Losses"), resulting from any (i) breach by
Innovex or its employees of its obligations hereunder or under any Work
Order; (ii) willful misconduct or negligent acts or omissions of Innovex or
its employees; and (iii) violation by Innovex or its employees of any
municipal, county, state or federal laws, rules or regulations applicable
to the performance of Innovex's obligations under this Master Agreement or
any Work Order, except to the extent such Losses are determined to have
resulted from the negligence or willful misconduct of TMC or its employees.
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9.2 TMC shall indemnify, defend and hold harmless Innovex, its Affiliates and
its and their respective directors, officers, employees and agents from and
against any and all Losses resulting from (i) the manufacture, storage,
packaging, production, transportation, distribution, sale or other
disposition of the TMC Products by TMC or its agents; (ii) breach by TMC or
its employees of its obligations hereunder or under any Work Order; (iii)
willful misconduct or negligent acts or omissions of TMC or its employees;
and (iv) violation by TMC or its employees of any municipal, county, state
or federal laws, rules or regulations applicable to the performance of
TMC's obligations under this Master Agreement or any Work Order, except to
the extent such Losses are determined to have resulted from the negligence
or willful misconduct of Innovex or its employees.
9.3 The party seeking indemnification hereunder (the "Indemnified Party") shall
give the party obligated to indemnify (the "Indemnifying Party") prompt
written notice of any such claims, actions or proceedings (including a copy
thereof); and the Indemnified Party and its employees shall fully cooperate
with the Indemnifying Party and its legal representatives in the
investigation and defense of any matter which is subject of an
indemnification claim; provided, however, that Indemnified Party's failure
to comply with such obligations shall not constitute a breach of this
Master Agreement nor relieve the Indemnifying Party of its indemnification
obligations pursuant to this Section 9, except to the extent, if any, that
the Indemnifying Party's defense of the affected claim, action or
proceeding actually was materially impaired thereby. Neither party shall
settle or admit liability with respect to any Losses for which
indemnification is sought without the prior written consent of the other
party, which consent shall not be unreasonably with held or delayed. The
Indemnifying Party may assume the defense of such claims, action or
proceedings at its expense. In such event, the Indemnifying Party shall not
be liable for legal expenses of the Indemnifying Party unless the
Indemnified Party reasonably concludes that the parties have conflicting
interests or defenses in which case the Indemnified Party shall be entitled
to indemnification for reasonable fees and expenses of counsel.
9.4 Neither party, nor their respective Affiliates, nor any of Innovex's or its
Affliate's directors, officers, employees, subcontractors or agents of
either party or their respective Affiliates shall have any liability of any
type (including, but not limited to, contract, negligence and tort
liability), for any loss of profits, opportunity or goodwill, or any type
of special, incidental, indirect or consequential damage or loss, in
connection with or arising out of this Master Agreement, any Work Order, or
the obligations performed by either party hereunder, under any Work Order.
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CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
10. INSURANCE.
Innovex and TMC shall each, at its own cost and expense, obtain and
maintain in full force and effect as is reasonably necessary to insure
their respective obligations under this Agreement or any Work Orders issued
hereunder. Specifically, Innovex shall maintain the following insurance
during the Term (and any subsequent renewals thereof): (i) worker's
compensation insurance in accordance with the statutory requirements of
each state in which the Services are to be performed; (ii) employer's
liability insurance with a minimum limit of [**] dollars ($[**]); (iii)
comprehensive general liability insurance, including contractual liability,
with a minimum limit of [**] dollars ($[**]), combined single limit per
occurrence; (iv) comprehensive auto liability, covering bodily injury and
property damage, for owned, hired or non-owned automobiles with a minimum
limit of [**] dollars ($[**]), combined single limit per occurrence; and
(v) professional errors and omissions, with a minimum limit of [**]
($[**]), per occurrence. Each party shall provide the other party an
original signed certificate of insurance evidencing all coverage herein
required, within thirty (30) days after the effective date of this Master
Agreement. The certificate must provide that thirty (30) day's prior
written notice of cancellation or material change in insurance coverage
will be provided. The insurance obligations hereunder may be met by a
program of self-insurance.
11. TERM AND TERMINATION.
11.1 This Master Agreement shall commence on the date of execution and shall
continue until terminated as hereinafter provided (the "Term"). Each Work
Order shall include a statement of the Project start date and the Project
end date (the "Project Term").
11.2 TMC may terminate this Master Agreement without cause at any time during
the Term of the Master Agreement on ninety (90) days prior written notice
to Innovex. An individual Work Order under this Master Agreement may be
terminated without cause by TMC at any time during the Term of the Master
Agreement or during the Project Term, on ninety (90) days prior written
notice to Innovex. All Work Orders then in effect shall terminate on the
effective date of the termination of this Master Agreement.
11.3 Either party may terminate this Master Agreement by written notice if the
other party defaults in the performance of its material obligations under
this Master Agreement upon 30 days prior written notice. Either party may
terminate a Work Order at any time if the other party defaults in the
performance of its material obligations under the Work Order upon 30 days
prior written notice and subject to the terms of this Section 11.3. In the
event of such default, the party declaring the default shall provide the
defaulting party with written notice setting forth the nature of the
default, and the defaulting party shall have thirty (30) days to cure the
default. If the defaulting party fails to cure the default within the
foregoing time periods, the other party may terminate the Master Agreement
or Work Order, as the case may be, at any
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time thereafter if such default is continuing by written notice to the
defaulting party, which notice shall be effective upon receipt.
11.4 Either party may terminate this Agreement by written notice to the other
party, effective upon receipt with no right to cure the default, if the
other party files a petition for bankruptcy, reorganization or arrangement
under any state statute, or makes an assignment for the benefit of
creditors or takes advantage of any insolvency statute or similar statute,
or if a receiver or trustee is appointed for the property and assets of the
party and the receivership proceedings are not dismissed within sixty (60)
days of such appointment.
11.5 In the event this Master Agreement or a Work Order is terminated, TMC shall
(a) pay to Innovex all Fees for Services rendered under all Work Orders in
the case of termination of this Master Agreement or under the applicable
Work Order in the case of termination of such Work Order which are due and
owing to Innovex because of any completed performance of Innovex's
obligations prior to the effective date of termination; (b) pay all
Pass-Through Expenses actually incurred by Innovex under the Work Order(s)
being terminated prior to the effective date of termination; and (c) pay
any other costs which have been expressly identified in a Work Order as
being due upon termination of such Work Order.
11.6 Termination of this Master Agreement or any Work Order for whatever reason
shall not affect the accrued rights of either Innovex or TMC arising under
this Master Agreement or a Work Order, and all provisions which expressly
or by implication survive the termination or expiration of the Master
Agreement or a Work Order, including without limitation Sections 4, 6, 8
and 9 of this Master Agreement, shall remain in full force and effect.
12. RELATIONSHIP WITH AFFILIATES.
12.1 TMC agrees that Innovex may utilize the Services of its corporate
Affiliates to fulfill Innovex's obligations under this Master Agreement and
any Work Order although Innovex shall remain liable for the performance of
such obligations. Any Innovex Affiliate so utilized shall be (i) subject to
all of the terms and conditions applicable to Innovex under this Master
Agreement and the Work Order applicable to such Project(s), including, but
not limited to, provisions establishing the standards for performance, and
(ii) entitled to all rights and protections afforded Innovex under this
Master Agreement and the Work Order applicable to such Project(s),
including, but not limited to, the indemnity and limitation of liability
protections set forth herein. Any such Affiliate of Innovex may execute a
Work Order directly and, with respect to the corresponding Project, the
rights and obligations of the parties shall be governed by all of the terms
and conditions of this Master Agreement, to the same extent as if such
Innovex Affiliate was a party to this Master Agreement.
12.2 TMC and Innovex acknowledge that certain Affiliates of TMC may utilize the
services of Innovex (and its Affiliates) under this Master Agreement and
under any Work Order. Any TMC Affiliate which utilizes such services shall
be (i) subject to all of the terms and conditions applicable to TMC under
this Master Agreement and the Work Order applicable to such Project(s), and
(ii) entitled to all rights and protections afforded TMC under this Master
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Agreement and the Work Order applicable to such Project(s), including, but
not limited to, the indemnity and limitation of liability protections set
forth herein. Any such Affiliate of TMC may execute a Work Order directly
and, with respect to the corresponding Project, the rights and obligations
of the parties shall be governed by all of the terms and conditions of this
Master Agreement, to the same extent as if such TMC Affiliate was a party
to this Master Agreement.
13. COOPERATION.
All data and information in TMC's possession or control reasonably
necessary in the opinion of TMC for Innovex to conduct Project assignments
will be delivered by TMC to Innovex. Innovex shall not be liable to TMC nor
be deemed to have breached this Master Agreement or any Work Order as a
result of errors, delays or other consequences directly arising from TMC's
failure to provide documents, materials or information or to otherwise
cooperate with Innovex in order for Innovex to timely and properly perform
Innovex's obligations.
14. FORCE MAJEURE.
If the performance or observance of this Master Agreement or any obligation
of this Master Agreement or any Work Order is prevented or delayed by
reason of an act of God, civil commotion, storm, fire, riots, strikes,
legal moratorium, war or revolution, the party so affected shall, upon
prompt notice of such cause being given to the other party, be excused from
such performance or observance to the extent of such prevention or during
the period of such delay, provided that the party so affected shall use its
best efforts to avoid or remove the cause(s) of non-performance and
observance with utmost dispatch.
15. REVIEW OF WORK; AUDIT.
During the term of this Master Agreement, Innovex will permit TMC's
representative(s) (unless such representatives are competitors of Innovex),
at reasonable times and in a reasonable manner, and at TMC's expense, to
(i) examine the work performed hereunder to determine that the Services are
being conducted in accordance with the agreed terms, or (ii) audit the
financial records related to Innovex's performance of the Services.
16. NOTICES.
Any notice required or permitted to be given by either party shall be in
writing. All notices shall be to the parties and addresses listed below,
and shall be sufficiently given (i) when received, if delivered personally
or sent by facsimile transmission, or (ii) one business day after the date
mailed or sent by an internationally recognized overnight delivery service.
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If to Innovex: Innovex LP
c/o Innovex America Holding Company
00 Xxxxxxxxx Xxxx.
Xxxxxxxxxx, XX 00000
Attention: President
Fax: 000-000-0000
With a copy to: General Counsel
Innovex America Holding Corp.
00 Xxxxxxxxx Xxxx
Xxxxxxxxxx, XX 00000
Fax: 000-000-0000
If to TMC: Attention: Xxxxxx X. Xxxxx
The Medicines Company
0 Xxxxxx Xxx
Xxxxxxxxxx, XX 00000
Fax: 000-000-0000
With a copy to: Xxxxxx Xxxxxx
Xxxx & Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx XX 00000
Fax: 000-000-0000
17. ASSIGNMENT.
Except for Affiliates, as stated above in Section 12, neither party may
assign any of its rights or obligations under this Master Agreement or any
Work Order to any third party without the written consent of the other
party, which consent shall not be unreasonably withheld.
18. ARBITRATION.
Resolution of disputes concerning any aspect of the Services, this Master
Agreement or any Work Order, excluding termination, shall be accomplished
by good faith negotiations between TMC and Innovex, within thirty (30) days
after notice. If necessary, thereafter, resolution of such disputes shall
be accomplished, at written request of either party to the other party, by
binding arbitration, which shall not interfere with the timely rendering of
Services. Arbitration will be pursuant to the Rules of Conciliation and
Arbitration of the American Arbitration Association, using a three-person
panel of arbitrators, one (1) to be designated by TMC, one (1) by Innovex,
and a third to be agreed upon by the other two (2) arbitrators. If the two
party-appointed arbitrators are unable to agree on a third arbitrator
within thirty (30) days after the second arbitrator is appointed, the
American Arbitration Association shall select the third arbitrator.
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19. ADDITIONAL WARRANTIES AND REPRESENTATIONS.
19.1 Innovex and TMC warrant and represent to the other that they have the full
right and authority to enter into this Master Agreement and that there is
no impediment that would inhibit their ability to perform their respective
obligations under this Master Agreement or any Work Order.
19.2 Innovex and TMC agree to perform their obligations hereunder in a timely,
professional and competent manner. Innovex additionally shall use its best
efforts and exercise due care and sound business judgment in performing the
services.
19.3 TMC warrants and represents that it has the right to use all U.S. patent,
trademark or other intellectual property rights necessary for the unimpeded
manufacture, use and sale of TMC Products in the Territory.
20. GENERAL PROVISIONS
20.1 This Master Agreement shall be construed, governed, interpreted, and
applied in accordance with the laws of the State of New Jersey, without
giving effect to the principles of conflict of laws.
20.2 This Master Agreement contains the entire understandings of the parties
with respect to the subject matter herein, and cancels all previous
agreements (oral and written), negotiations and discussions, dealing with
the same subject matter including the Letter of Intent dated July 20, 2000,
as amended, between the parties. The parties, from time to time during the
term of this Master Agreement, may modify any of the provisions hereof only
by an instrument in writing duly executed by the parties.
20.3 References to any Schedule, Appendix, Attachment or Exhibit attached to
this Master Agreement or any Work Order shall be deemed to incorporate the
entire contents of the Schedule, Appendix, Attachment or Exhibit by
reference, as if it were fully set forth in the Master Agreement or Work
Order to which it is attached.
20.4 No failure or delay on the part of a party in either exercising or
enforcing any right under this Master Agreement or any Work Order will
operate as a waiver of, or impair, any such right. No single or partial
exercise or enforcement of any such right will preclude any other or
further exercise or enforcement thereof or the exercise or enforcement of
any other right. No waiver of any such right will have effect unless given
in a signed writing. No waiver of any such right will be deemed a waiver of
any other right.
20.5 If any part or parts of this Master Agreement or a Work Order are held to
be illegal, void or ineffective, the remaining portions of the Master
Agreement or Work Order shall remain in full force and effect. If any of
the terms or provisions are in conflict with any applicable
12
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statute or rule of law, then such term(s) or provision(s) shall be deemed
inoperative to the extent that they may conflict therewith, and shall be
deemed to be modified or conformed with such statute or rule of law. In the
event of any ambiguity respecting any term or terms hereof, the parties
agree to construe and interpret such ambiguity in good faith in such a way
as is appropriate to ensure its enforceability and viability. Neither party
shall assert against the other that the compensation arrangement provided
in this Agreement or any Work Order is ground for voiding the Agreement or
Work Order, or rendering the same unenforceable.
20.6 The headings contained in this Master Agreement and any Work Order are used
only as a matter of convenience, and in no way define, limit, construe or
describe the scope or intent of any section of this Master Agreement or
such Work Order.
IN WITNESS WHEREOF, this Master Agreement has been executed by the parties
hereto through their duly authorized officers on the date(s) set forth below.
INNOVEX LP THE MEDICINES COMPANY
By: Innovex America Holding
Company, its General Partner
By: /s/ Xxxx X. Xxxxxxx By: /s/ Xxxxxx X. Xxxxx
-------------------- ---------------------
Name: Xxxx X. Xxxxxxx Name: Xxxxxx X. Xxxxx
Title: President Title: VP Sales and Marketing
Date: November 17, 2000 Date: November 17, 2000
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EXHIBIT A TO THE MASTER SERVICE AGREEMENT
ANGIOMAX
THE MEDICINES COMPANY BIVALUATION
--------------------------------------------------------------------------------
MEDICAL INQUIRY/PRODUCT COMPLAINT/ADVERSE EVENT FAX FORM
TO: MEDICAL INFORMATION DEPARTMENT
----------------------------------
DATE: SALES REP:
---------------------------------- --------------------------------------
FAX: (000) 000-0000 VOICEMAIL:
---------------------------------- --------------------------------------
--------------------------------------------------------------------------------
FROM: (NAME)
--------------------------------------------------------------------------------
[ ] M.D. [ ] D.O. [ ] Pharm.D. [ ] X.Xx. [ ] R.N. [ ] OTHER:
---------------
TITLE:
--------------------------------------------------------------------------------
INSTITUTION/OFFICE:
--------------------------------------------------------------------------------
ADDRESS:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CITY: STATE: ZIP:
--------------------------------------------------------------------------------
TELEPHONE: FAX:
--------------------------------------------------------------------------------
SIGNATURE:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
[ ] PLEASE SEND INFORMATION ON ANGIOMAX (SPECIFY QUESTION/REQUEST):
[ ] REPORTING A PRODUCT COMPLAINT (SPECIFY DETAILS OF COMPLAINT):
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
[ ] IF REPORTING AN ADVERSE EVENT FOR A PRODUCT:
PATIENT ID (INITIALS): AGE: SEX: Wt. KG/LB
--------------------------------------------------------------------------------
PLEASE SPECIFY PRODUCT AND BRIEFLY DESCRIBE ADVERSE EVENT:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
FOR FASTER RESPONSE OR TO DIRECTLY REPORT AN ADVERSE EVENT, YOU MAY CALL THE
MEDICAL INFORMATION DEPARTMENT AT 800-ANGIOMAX, 9:00 AM-7:00 PM EST, MONDAY-
FRIDAY. MCS REF. #
---------------------
VENDOR 2.0 NOVEMBER 7, 2000
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APPENDIX I
WORK ORDER TEMPLATES
APPENDIX I-A, SAMPLE WORK ORDER
APPENDIX I-B, SALES FORCE WORK ORDER
15
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APPENDIX I-A, SAMPLE WORK ORDER
WORK ORDER # _____
EFFECTIVE DATE OF WORK ORDER: ___________________
This Work Order is entered into between ("Customer") [or other Customer
Affiliate] and Innovex LP ("Innovex"), [or other Innovex Affiliate] pursuant to
the Master Services Agreement, having an Effective Date , between Customer and
Innovex LP, and is subject to all the terms and conditions set forth therein,
except as may be otherwise expressly provided herein.
BRIEF DESCRIPTION OF PROJECT:
[Insert BRIEF description of project, identifying the product or products, and
describing the target audience and objectives]
PROJECT TEAMS:
[Identify Project Liaisons or key members of project team for both Customer and
Innovex].
CUSTOMER CONTACT PERSON:
ADDRESS:
--------------------------------
PHONE:
--------------------------------
FAX:
--------------------------------
INNOVEX CONTACT PERSON:
ADDRESS:
--------------------------------
PHONE:
--------------------------------
FAX:
--------------------------------
Routine correspondence relevant to the operation of the Project should be sent
to the above-named contact persons. All notices or similar communications in
regard to the terms or a change of terms of this Work Order are to be sent to
the parties named in the Master Services Agreement - Section 16. Notices.
16
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PROJECT TERM AND KEY DATES:
-------------------------------------------------------------------------------
Project Start Date
-------------------------------------------------------------------------------
Project personnel Start Date
-------------------------------------------------------------------------------
Initial Training Dates
-------------------------------------------------------------------------------
Project End Date (Last Day Worked)
-------------------------------------------------------------------------------
"Project Term" shall mean the period of time beginning on the Project Start Date
and ending on the Project End Date. Any renewal of the Project or extension of
the Project End Date shall be negotiated by the parties at least ninety (90)
days before the Project End Date, and shall be effective when agreed in writing.
DEFINITIONS
[insert appropriate definitions for the Project]
1. "Day Worked" shall mean a day during which Project personnel performs
Services, or attends scheduled company training and/or specifically
designated home study. Days Worked shall not include days on leave,
holidays, sick days, vacations or any Saturday or Sunday, except for
training days scheduled on a Saturday or Sunday. The average number of days
worked in a twelve month period shall be two hundred thirty-two (232).
2. "Product" shall mean the Customer pharmaceutical products specifically
identified in the Work Order or any other product involved in the Services,
as mutually agreed between Innovex and Customer.
INNOVEX RESPONSIBILITIES AND OBLIGATIONS
[insert description of Project personnel, recruitment qualfications, personnel
duties and responsibilities,compensation, reporting expectations, milestones,
deliverables, deadlines, etc]
CUSTOMER RESPONSIBILITIES AND OBLIGATIONS
[Description of Customer responsibilities for product or program materials,
training, equipment, etc]
FEES AND PASS-THROUGH EXPENSES
[Describe Daily Fees, Pass-Through Expenses, Payment Schedule, Deposit
Requirements, etc.]
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SPECIAL TERMS
[insert or attach any other special terms applicable to project; such as agreed
upon terms for sharing risk/reward for specific project e.g. bonus/penalty tied
to specific performance measures]
In Witness Whereof, Customer and Innovex have caused this Work Order # _____to
be duly executed on their behalf by their authorized representatives and made
effective as of Effective Date of Work Order appearing above.
ACCEPTED AND AGREED TO BY:
CUSTOMER INNOVEX LP
BY: INNOVEX AMERICA HOLDING
COMPANY, ITS GENERAL PARTNER
EXAMPLE - NOT FOR SIGNATURE
---------------------------- -----------------------------
By: By:
Title: Title:
Date: Date
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APPENDIX I - B
[THIS WORK ORDER TEMPLATE IS DESIGNED SPECIFICALLY FOR A CONTRACT SALES FORCE.
THE DESCRIPTION OF DUTIES AND OBLIGATIONS FOR INNOVEX AND CUSTOMER WILL VARY,
DEPENDING ON THE SIZE OF THE SALES FORCE, COST CONSIDERATIONS, AND CUSTOMER
DECISIONS REGARDING TRAINING, SALES FORCE AUTOMATION, AND EXTENT OF PASS-THROUGH
EXPENSES.]
SALES FORCE WORK ORDER # _____
EFFECTIVE DATE OF WORK ORDER: ___________________
This Sales Force Work Order is entered into between ("Customer") [or other
Customer Affiliate] and Innovex LP ("Innovex"), [or other Innovex Affiliate]
pursuant to the Master Services Agreement, having an Effective Date , between
Customer and Innovex LP, and is subject to all the terms and conditions set
forth therein, except as may be otherwise expressly provided herein.
BRIEF DESCRIPTION OF SALES FORCE PROJECT:
[Insert BRIEF description of sales force project, identifying the product or
products, and describing the target audience]
PROJECT TEAMS:
[Identify Project Liaisons or key members of project team for both Customer and
Innovex].
CUSTOMER CONTACT PERSON:
ADDRESS:
--------------------------------
PHONE:
--------------------------------
FAX:
--------------------------------
INNOVEX NATIONAL SALES MANAGER:
ADDRESS:
--------------------------------
PHONE:
--------------------------------
FAX:
--------------------------------
Routine correspondence relevant to the operation of the sales force should be
sent to the above-named contact persons. All notices or similar communications
in regard to the terms or a change of terms of this Work Order are to be sent to
the parties named in the Master Services Agreement - Section 16. Notices.
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PROJECT TERM AND KEY DATES:
-----------------------------------------------------------------------------
Project Start Date
-----------------------------------------------------------------------------
District Manager, Field Coordinator Start Date
-----------------------------------------------------------------------------
Sales Representative Start Date
-----------------------------------------------------------------------------
Initial Training Dates
-----------------------------------------------------------------------------
Project End Date (Last Day Worked)
-----------------------------------------------------------------------------
"Project Term" shall mean the period of time beginning on the Project Start Date
and ending on the Project End Date. Any renewal of the Project or extension of
the Project End Date shall be negotiated by the parties at least ninety (90)
days before the Project End Date, and shall be effective when agreed in writing.
DEFINITIONS
1. "Day Worked" shall mean a day during which a Sales Representative details
Prescribers, or attends scheduled company training and/or specifically
designated home study. A "Day Worked" by a District Manager shall mean a
day during which the District Manager performs duties and responsibilities
described in the Work Order. Days Worked shall not include days on leave,
holidays, sick days, vacations or any Saturday or Sunday, except for
training days scheduled on a Saturday or Sunday. The average number of days
worked in a twelve month period shall be two hundred thirty-two (232).
2. "Detail" shall mean an interactive face-to-face contact by a Sales
Representative with a Prescriber or the Prescriber's legally empowered
designee, during which a promotional message involving the Product is given
in accordance with the Promotional Program. When used as a verb, "detail,"
"details" and "detailed" shall mean to engage in a Detail as defined
herein.
3. "Prescriber" shall mean physicians and other health care professionals
legally authorized to write prescriptions for pharmaceutical products.
4. "Product" shall mean the Customer pharmaceutical products specifically
identified in the Work Order or any other product whose promotion and
detailing is assigned to Innovex by mutual agreement with Customer.
[optional: if medical device, redefine accordingly, and change references
from "Prescriber" to "Practitioner"]
5. "Promotional Expense Budget" shall mean the funding and guidelines for use
of such funding that are provided by Customer for use by the Sales Force
when detailing Product.
6. "Promotional Material" shall mean the Product labeling and package inserts,
sales aids and detailing materials, and other promotional support items
provided by Customer to Innovex, for use in promotion of the Product.
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7. "Promotional Program" shall mean the marketing plan, strategy and
promotional message for the Product, which will include use of the
Promotional Material and the Promotional Expense Budget.
8. "Sales Force" shall mean the Sales Representatives, District Managers,
Regional Sales Managers and National Sales Manager, individually and as a
group, that have been assigned to deliver Details of the Product in
accordance with the terms of this Agreement.
9. "Sales Representative" shall mean an Innovex employee who has been trained
and equipped to detail Prescribers.
10. "Target Prescriber" shall mean one of the specifically identified
Prescribers within a Sales Representative's territory to be detailed by the
Sales Representative.
11. "Territory" shall mean the United States and Puerto Rico. In connection
with an individual Sales Representative, the territory shall be the
geographic area assigned to the individual Sales Representative.
INNOVEX RESPONSIBILITIES AND OBLIGATIONS
1. SALES FORCE. The Sales Force will be composed of the following Innovex
employees:
NUMBER POSITION TITLE
------ --------------
Sales Representatives
-------------------------------------------------------------------------------
District Managers [or Field Coordinators]
-------------------------------------------------------------------------------
Regional Sales Managers
-------------------------------------------------------------------------------
National Sales Manager
-------------------------------------------------------------------------------
Project Administrator (Administrative Assistant)
-------------------------------------------------------------------------------
Customer may request that Innovex provide additional Sales Representatives,
by submitting a written request in substantially the form attached hereto
as Exhibit 1, ("Additional Sales Representative Request Form"). As the
total number of Sales Representatives increases for the Sales Force,
additional District Managers will also be increased in order to maintain a
target ratio of District Managers to Sales Representatives of approximately
1:12.
2. RECRUITMENT. Innovex shall be responsible for recruitment and
re-recruitment (replacement) of the Sales Representatives and District
Managers in accordance with the Sales Force Qualifications described below.
Innovex shall be responsible for the cost of recruitment, background checks
and drug screens. If Customer elects to participate in the final selection
of members of the Sales Force, Customer shall approve or disapprove
qualified candidates within five (5) business days after each qualified
candidate is submitted to Customer for final selection. If Customer rejects
three qualified candidates for a territory, Customer shall be charged a fee
of $ ___ for each additional qualified candidate submitted by Innovex,
until ----------- the territory is filled. A "qualified candidate" must
meet the Sales Force Qualifications.
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3. SALES FORCE QUALIFICATIONS. Innovex will exercise best efforts to recruit
from a diverse candidate base. A qualified candidate for Sales
Representatives shall meet the following minimum qualifications: four-year
college degree (B.A., B.S. or equivalent); __________ outside sales
experience, _______________. A qualified candidate for District Manager
shall meet the following minimum qualifications: four-year college degree
(B.A., B.S. or equivalent); ______outside sales experience, _________
previous management experience.
1. POSITION DESCRIPTIONS AND DUTIES. Innovex shall manage, supervise and
evaluate the performance of the National Sales Manager, Regional Sales
Managers, District Managers and Sales Representatives in accordance with
the responsibilities and duties identified below. All Sales Force employees
shall demonstrate the following: work ethic and integrity; planning,
organizing and territory management skills; strong interpersonal skills;
excellent communication skills; critical thinking and analysis; problem
solving; decisiveness; sound judgment; customer-focused selling skills;
basic computer skills; ability to listen and learn.
SALES REPRESENTATIVES
- Generate sales within an assigned territory
- Maintain and update current and prospective target physician
profiles
- Keep current with market knowledge and competitive products
- Maintain a professional image for Customer and Customer Products
- Participate in all training and sales meetings
- Plan and organize territory to meet sales and call targets
- Make sales presentations (details) - individual, one-on-one,
in-services
- Maintain sample inventories, distribute samples, comply with
sample accountability procedures and policies, comply with PDMA
- Make complete, accurate and timely submission of all
time-keeping, call activity, sample activity and expense reports
- Compliance with Promotional Program, and proper use of
Promotional Materials and Promotional Expense Budgets
NATIONAL SALES MANAGER, REGIONAL SALES MANAGERS, DISTRICT MANAGERS
- Recruit, interview and select Sales Representatives and
subordinate managers
- Handle periodic performance review, personnel issues, discipline
and termination of Sales Representatives and subordinate managers
- District Managers shall make regular field visits: to develop and
motivate Sales Representatives for attainment of sales
objectives; to assess and monitor field activity and work
schedules; to monitor and manage field reporting by Sales
Representatives, including call and sample reporting.
- Communicate with Customer field/regional managers on regular and
timely basis
- Assist with the planning and delivery of training, and periodic
sales meetings
- Review and approve expense reports; monitor compliance with
expense policies.
- Monitors compliance with Promotional Program, and proper use of
Promotional Materials and Promotional Expense Budgets
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- Monitors compliance with PDMA and sample accountability
procedures
FIELD COORDINATORS [ALTERNATIVE TO DISTRICT MANAGERS]
- Assist with recruitment of Sales Representatives
- Handle periodic performance review, personnel issues, discipline
and termination of Sales Representatives
- Review and approve expense reports; monitor compliance with
expense policies
- Conduct field visits with Sales Representatives as schedule
permits in order to: assess and monitor field activity and work
schedules; to monitor and manage field reporting, including call
and sample reporting; to implement performance or disciplinary
plans.
- Communicate with Customer field/regional managers on regular and
timely basis
- Assist with the planning and delivery of training, and periodic
sales meetings, if necessary
5. SALES FORCE COMPENSATION; BENEFITS. Innovex shall compensate the Sales
Force employees with a combination of salary and variable incentive
(bonus). Innovex shall establish a target average salary and salary matrix,
which recognizes greater experience and training, and preferred selection
criteria. The terms and conditions of a variable incentive compensation
plan ("Incentive Plan") shall be mutually determined by Innovex and
Customer, including eligibility criteria and performance targets. The plan
may also include incentive awards such as trips and prizes. Innovex shall
administer the Incentive Plan, determine eligibility and pay the incentive
compensation and awards, in accordance with the Incentive Plan. Sales Force
employees shall be eligible to receive an auto allowance, and shall be
entitled to participate in the Innovex employee benefit plans for health
and dental care, 401K, employee stock purchase and stock ownership plans,
in accordance with company eligibility criteria.
6. TRAINING AND PERIODIC SALES MEETINGS.[Describe Innovex duties to match
project proposal] Innovex shall assist Customer with organizing and
delivering initial training of the Sales Force, backfill training of
replacement District Managers and Sales Representatives and all follow-up
training, including periodic sales meetings.
7. PROMOTIONAL ACTIVITIES. Innovex shall be responsible for managing and
monitoring the promotional activities of the Sales Force, in strict
adherence to the Promotional Program and using only the Promotional
Materials provided by Customer. Sales Representatives shall not be
permitted to develop, create or use any other promotional material or
literature in connection with the promotion of the Product. The Sales
Representatives will be required to immediately cease the use of any
Promotional Materials when instructed to do so by Customer. Innovex shall
monitor that Promotional Materials are not changed, (including, without
limitation, by underlining or otherwise highlighting any text or graphics
or adding any notes thereto) by the Sales Representatives. Sales
Representatives shall be required to limit their statements and claims
regarding the Product, including as to efficacy and safety, to those which
are consistent with the Product labels, package inserts and Promotional
Materials. The Sales Representatives shall not be permitted to add, delete
or modify claims of the efficacy or safety in the promotion of the Product,
nor shall the Sales Representatives be permitted to
23
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make any untrue or misleading statements or comments about the Products or
any Customer competitors or competitor products.
8. PROJECT REPORTS. Innovex shall provide Customer a monthly Project report,
which shall include: (i) headcount, reported nationally, by
region/district; vacancy rates, turnover, personnel transfers to Customer,
status of recruitment/hiring; (ii) Project status, milestones, and progress
toward achieving objectives; (iii) financial accountability, tracking
expenses against budget; [and (iv) if required by the Work Order, call
reporting and sample accountability].
9. REPORTING BY SALES REPRESENTATIVES. Sales Representatives shall be required
to report all field activities and expenditures in a manner that is timely,
accurate and honest, and in accordance with policies and procedures for the
applicable reporting systems. Innovex District Managers shall routinely
reinforce the importance of compliance with the reporting guidelines and
policies (e.g. sample accountability, call reporting, promotional budget
expenditures, travel expenses). Newly hired Sales Representatives shall
receive training on the reporting systems, guidelines and policies during
the initial sales training program
10. RECEIPT FOR CUSTOMER PROPERTY. [If Customer supplies laptop computers] Upon
delivery of computer hardware and software to members of the Sales Force,
Customer will receive signed receipts in substantially the form attached
hereto as Exhibit 2. Innovex will also receive a copy of each receipt.
11. PDMA AND SAMPLE ACCOUNTABILITY. The Sales Force shall be responsible for
strict adherence to the PDMA and the Customer sample accountability
policies and procedures. Innovex shall provide immediate assistance to
Customer in connection with investigation of discrepancies, thefts,
significant losses and suspected falsification of sample records. Innovex
agrees to produce any written sample records that are maintained by
Innovex, within two business days after Customer request. [Optional] ITMS,
CALL REPORTING AND SAMPLE ACCOUNTABILITY. Innovex shall provide the Innovex
Territory Management System, including automated call reporting and sample
accountability functions. Innovex shall have primary responsibility for
Sales Force compliance with the requirements of the FDA Final Rule
implementing the PDMA (21 CFR Parts 203 & 205), including, but not limited
to (a) a sample accountability and tracking system for use by the Sales
Representatives; (b) verification of licensed practitioners; (c) annual
physical inventories and reconciliation reports; (d) monitoring and
investigation of discrepancies, significant losses, thefts and
falsification of sample records; (e) notification and reporting to FDA, in
conjunction with Customer; (f) a sample distribution security and audit
system, including conducting random and for cause audits of sales
representatives by personnel independent of the sales force; and (g)
training the Sales Force regarding the foregoing. Innovex agrees to produce
any written sample records that are maintained by Innovex, within two
business days after Customer request. Innovex shall equip the Sales Force
with computer hardware and software, and shall bear the cost of database
and system administration, licenses, access to data/replication lines, help
desk support, and training of the Sales Force in proper use of the
computers and software.
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CUSTOMER RESPONSIBILITIES AND OBLIGATIONS
[Description of Customer responsibilities for training and sales meetings,
sample accountability systems and call reporting may be significantly different
if Innovex is engaged to provide training and/or SFA. The content of the Work
Order should be modified to fit the agreed proposal as accepted by Customer]
1. PROMOTIONAL PROGRAM AND PROMOTIONAL MATERIALS. Customer shall be
responsible for providing a Promotional Program, Promotional Materials and
Promotional Expense Budget that (i) will not involve the counseling or
promotion of a business arrangement that violates federal or state law;
(ii) will be in compliance with the AMA Guidelines on Gifts to Physicians
from Industry; and (iii) shall not require or encourage the Sales
Representatives to offer, pay, solicit or receive any remuneration from or
to Prescribers to induce referrals or purchase of Customer Product.
Customer shall be responsible for providing written guidelines for proper
use of the Customer's Promotional Expense Budget.
2. TRAINING AND PERIODIC SALES MEETINGS.
Customer shall be responsible for the following:
- Programming, materials and facilities for initial Sales Force training
of ____ days duration. The initial training agenda shall include hours
designated for Innovex training regarding personnel management,
compensation and benefits and field administration.
- Programming, materials and facilities for periodic sales meetings or
product launch meetings. [e.g. trimester, quarterly; specify annual
total training/meeting days].
3. PDMA AND SAMPLE ACCOUNTABILITY. Samples of the Customer Products shall be
distributed to the Sales Representatives in quantities and in a manner
determined by Customer and at Customer's expense. Customer shall be
responsible for the cost of sample storage facilities, if necessary to
comply with Customer instructions. Customer shall have primary
responsibility for compliance with the requirements of the FDA Final Rule
implementing the PDMA (21 CFR Parts 203 & 205), including, but not limited
to (a) a sample accountability and tracking system for use by the Sales
Representatives; (b) verification of licensed practitioners; (c) annual
physical inventories and reconciliation reports; (d) monitoring and
investigation of discrepancies, significant losses, thefts and
falsification of sample records; (e) notification and reporting to FDA; (f)
a sample distribution security and audit system, including conducting
random and for cause audits of sales representatives by personnel
independent of the sales force; and (g) training the Sales Force regarding
the foregoing. Customer and Innovex shall cooperate in connection with PDMA
compliance investigations and audits. Customer will provide to Innovex for
review and comment, a copy of any PDMA compliance report in connection with
the Sales Force, prior to filing with the FDA. Customer will provide
Innovex with results of annual Sales Representative sample inventories.
[revise this section if Innovex provides ITMS and/or sample accountability]
4. SALES DATA. Customer shall be solely responsible for obtaining historic and
ongoing sales data regarding Customer Products. [revise if Innovex provides
Synergy data]
25
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5. CALL REPORTING SYSTEM AND COMPUTERS. Customer shall be responsible for
providing a call reporting system and equipping Sales Representatives with
computer hardware and software necessary to carry out the Promotional
Program. Customer shall bear the cost of the hardware and software,
including appropriate licenses, upgrades, access to data/replication lines,
help desk support, and training of the Sales Force in proper use of the
call reporting system and computers. [delete this provision if Innovex
provides ITMS]
6. BUSINESS CARDS; DETAIL BAGS. Customer shall supply the Sales Force with
business cards, the content of which shall be subject to approval by
Innovex, such approval not to be unreasonably withheld. Customer shall
supply the Sales Force with detail bags.
7. SALES FORCE TRAVEL EXPENSES. Customer shall be responsible for the
following Sales Force travel, lodging and meal expenses, when necessary and
actually incurred by the Sales Force (in the amounts authorized in a
mutually agreed Sales Force travel expense budget):
- Travel expenses for Sales Representatives and District Managers to
participate in recruitment interviews with Customer.
- Travel expenses of Sales Force in connection with all training and
periodic sales meetings
- Travel expenses for District Managers, Regional Sales Managers and
National Sales Manager in connection with field management in the
territories.
FEES AND PASS-THROUGH EXPENSES
1. DAILY FEES. Customer shall pay Innovex a Daily Fee for each Day Worked by
Sales Representatives and Field Managers during the Project Term. The Daily
Fees and total estimated Daily Fees during the Project Term are stated in
the following table:
ESTIMATED
ESTIMATED TOTAL DAYS ESTIMATED
SALES FORCE POSITIONS NUMBER DAILY RATE DAYS WORKED WORKED TOTAL FEES
--------------------------------------------------------------------------------------------------------------
Sales Representatives $
--------------------------------------------------------------------------------------------------------------
District Managers $
--------------------------------------------------------------------------------------------------------------
Regional Sales Managers $0
--------------------------------------------------------------------------------------------------------------
National Sales Manager $0
--------------------------------------------------------------------------------------------------------------
Project Administrator (AA) $0
--------------------------------------------------------------------------------------------------------------
ESTIMATED TOTAL FEES $
--------------------------------------------------------------------------------------------------------------
2. TAKE-ON FEE. Innovex shall charge Customer a fee for each Sales
Representative or District Manager that becomes employed by Customer or an
affiliate during the Project Term or within ninety (90) days thereafter.
The fee shall be equal to _____________ percent (%) of the employee's
Innovex annual salary, and shall be due and payable upon commencement of
such employment by Customer.
3. INCENTIVE PLAN ADMINISTRATION. [If bonus pool is a pass-through expense]
Customer shall pay Innovex an amount equal to (i) the amount of all
incentive compensation earned by Sales Representatives and District
Managers in accordance with the terms of the Incentive Plan; and
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(ii) an amount equal to _____ percent (___%) of the incentive compensation
for Innovex's employer costs (payroll taxes).
[Optional] ITMS FEES. Customer shall pay the following fees in connection
with ITMS: (a) fees for start-up and deployment in the amount of $_____, no
later than _______; and (b) a monthly ITMS services fee in the amount of
$______, payable in ____ equal installments, beginning _________.
4. PAYMENT SCHEDULE. Innovex shall invoice Customer monthly for all Daily
Fees, Take-on Fees and Pass-Through Expenses. At the end of each calendar
month Innovex shall provide Customer a list of the billable Sales Force
personnel and the total number of Days Worked multiplied by the respective
Daily Fee rate. Innovex shall invoice Customer in advance for all incentive
compensation and related employer costs, and the incentive compensation
shall be paid to the Innovex Personnel by Innovex only after Customer pays
to Innovex the amount of the applicable incentive compensation invoices.
5. RECOVERY OF COSTS UPON EARLY TERMINATION. If Customer terminates this Work
Order before the expiration of the Project Term, then in addition to all
Fees and Pass-through Expenses that are payable in accordance with Section
11.5 of the Master Services Agreement, Customer shall also pay to Innovex
(a) any non-cancelable obligations incurred in accordance with the terms of
this Work Order, net of recoveries (e.g. cancellation fees, computer lease
termination fees); and (b) the amount of $____________ for each month
remaining in the Project Term (at the conclusion of the contractual notice
period), to compensate Innovex for unamortized costs of recruitment and
training.
6. FEE DEPOSIT. The advance payment in the amount of $ ___________________,
currently held by Innovex in connection with the Letter of Intent between
Customer and Innovex, dated ________________________________ , shall
continue to be held by Innovex and will be credited against the invoices
for Fees and Pass-Through Expenses for the final two months of the Project
Term.
7. EXPENSE ALLOCATION CHART. The financial responsibility of Innovex and
Customer for expenses and costs of Sales Force operation shall be allocated
in accordance with the terms of this Work Order, which are summarized for
illustrative purposes in the "Sales Force Expense Allocation" chart
(Attachment A).
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SPECIAL TERMS
[insert or attach any other special terms applicable to project; such as agreed
upon terms for sharing risk/reward for specific project e.g. bonus/penalty tied
to specific performance measures]
In Witness Whereof, Customer and Innovex have caused this Work Order # _____to
be duly executed on their behalf by their authorized representatives and made
effective as of Effective Date of Work Order appearing above.
ACCEPTED AND AGREED TO BY:
CUSTOMER INNOVEX LP
BY: INNOVEX AMERICA HOLDING
COMPANY, ITS GENERAL PARTNER
EXAMPLE - NOT FOR SIGNATURE
---------------------------- -----------------------------
By: By:
Title: Title:
Date: Date
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ATTACHMENT A TO SALES FORCE WORK ORDER
SALES FORCE EXPENSE ALLOCATION
DATE
PROJECT #
(NOTE: ADD OR DELETE LINE ITEMS TO MATCH THE PROPOSAL AND COST MODEL ACCEPTED BY
CUSTOMER)
-------------------------------------------------------------------------------------------------------------------------
CATEGORY INNOVEX PASSTHROUGH CUSTOMER
DIRECT EXPENSES DIRECT
EXPENSES EXPENSES
-------------------------------------------------------------------------------------------------------------------------
Salary, including payroll taxes, for Sales Representatives, District X
Managers, Regional Sales Managers, National Sales Manager
-------------------------------------------------------------------------------------------------------------------------
Incentive compensation (bonus) for Sales Representatives, including X
payroll taxes
-------------------------------------------------------------------------------------------------------------------------
Benefits package, including (401k), ESOP, ESPP, medical, dental, Rx, X
vacation, holidays
-------------------------------------------------------------------------------------------------------------------------
Auto Costs, including monthly allowance, mileage reimbursement, parking and
tolls. X
-------------------------------------------------------------------------------------------------------------------------
Basic Business Expenses, including phone, paper supplies, postage and voice
mail. X
-------------------------------------------------------------------------------------------------------------------------
Business Cards & Detail Bags X
-------------------------------------------------------------------------------------------------------------------------
Call Reporting & Sample Accountability; ITMS X
-------------------------------------------------------------------------------------------------------------------------
Computers for Sales Representatives, including software, helpdesk X
support, data/replication lines
-------------------------------------------------------------------------------------------------------------------------
Computers for DMs, RSMs, NSM, including software, helpdesk support, X
data/replication lines
-------------------------------------------------------------------------------------------------------------------------
Infrastructure support (operations, HR, finance, legal) X
-------------------------------------------------------------------------------------------------------------------------
Liability Insurance: employment, workers comp, E & O, CGL, auto X
-------------------------------------------------------------------------------------------------------------------------
Recruitment and re-recruitment, includes drug screens, background and X
motor vehicle checks
-------------------------------------------------------------------------------------------------------------------------
Meetings: Customer national, regional and district meetings; product X
launches
-------------------------------------------------------------------------------------------------------------------------
Promotional Expense Budget (access money) X
-------------------------------------------------------------------------------------------------------------------------
Promotional Program and Promotional Materials (sales aids) X
-------------------------------------------------------------------------------------------------------------------------
Promotional marketing expenses, including sales data X
-------------------------------------------------------------------------------------------------------------------------
Samples, including distribution to Sales Representatives X
-------------------------------------------------------------------------------------------------------------------------
Sample Storage X
-------------------------------------------------------------------------------------------------------------------------
Training program, materials and facilities; initial and follow-up X
-------------------------------------------------------------------------------------------------------------------------
Travel Expenses (air, hotel & meals) for Sales Reps, District X
Managers, Regional Sales Managers, National Sales Manager X
*Interviewing X
*Training X
*Territory travel for field management purposes X
-------------------------------------------------------------------------------------------------------------------------
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[optional form]
EXHIBIT 1 TO SALES FORCE WORK ORDER
ADDITIONAL SALES REPRESENTATIVE REQUEST FORM
This Request for Additional Sales Representative is issued pursuant to the
Master Sales Services Agreement between Customer and Innovex LP, dated , and
Work Order # _______, dated _____________. (Sales Force # _______).
--------------------------------------------------------------------------------
PART 1 To be completed by Customer
Attach any relevant, helpful information
--------------------------------------------------------------------------------
NUMBER OF SALES REPRESENTATIVES
REQUESTED
--------------------------------------------------------------------------------
TERRITORY LOCATION(S)
--------------------------------------------------------------------------------
REQUESTED START DATE
--------------------------------------------------------------------------------
AUTHORIZED CUSTOMER REPRESENTATIVE Signature: ______________________________
SUBMITTING REQUEST Name:
Title:
Date:
Phone:
Fax:
--------------------------------------------------------------------------------
PART 2 TO BE COMPLETED BY INNOVEX
INNOVEX SHALL RESPOND WITHIN TEN (10)
BUSINESS DAYS AFTER RECEIPT OF THE
ADDITIONAL SALES REPRESENTATIVES REQUEST.
--------------------------------------------------------------------------------
This Additional Sales Representative Request is Accepted, and Recruitment
Request Form was Received by Innovex shall begin immediately:
on the following date:
----------------------------------------
(sign and date)
_____________________ Contact Person:
Phone:
--------------------------------------------------------------------------------
REQUEST IS NOT ACCEPTED (identify above
information which must be clarified or
changed before Request may be accepted
by Innovex):
----------------------------------------
(sign and date)
Contact Person:
Phone:
--------------------------------------------------------------------------------
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[optional form]
EXHIBIT 2 TO SALES FORCE WORK ORDER
RECEIPT FOR CUSTOMER PROPERTY
I acknowledge receipt of the following computer hardware and software from
Customer:
Equipment
[List with serial nos.]
Software
[List]
Total Approximate Value $_________ [INSERT VALUE AGREED TO BY INNOVEX &
CUSTOMER]
I certify that I will use the Customer hardware and software listed above, as
well as any other material provided to me by Customer, solely for the purpose of
providing services for Customer in connection with the Sales Force project, and
in accordance with any applicable directions given by Customer to Innovex. I
further certify that I will not copy or reproduce any of the software listed
above without the express written permission of Customer. I will not install any
software that is not authorized in advance by Customer and Innovex (e.g. AOL,
screen savers, etc.). I acknowledge and understand I may be held personally
responsible for loss or damage which results from misuse, abuse, failure to
safeguard or failure to return the computer, hardware and software.
If I have technical problems with the hardware or software listed above, I will
promptly contact the Customer help desk or technical support services, in
accordance with the instructions provided to me.
I certify that I will return the hardware and software listed above, as well as
all other material provided to me by Customer, when I no longer need it to
perform services on behalf of Customer, or upon request by Customer. Upon
termination of my employment with Innovex, for any reason whatsoever, or if
otherwise requested by Customer or Innovex, I promise to immediately return the
computer, hardware and software.
I further understand that if I fail to immediately return the Customer property
when required or requested to do so, that Innovex and/or Customer may take any
lawful action deemed necessary to recover possession. I agree and give my
consent that Innovex may set off the value of the unreturned property against
any amounts owed to me by Innovex, including salary, bonus compensation and
expense reimbursements, to the full extent permitted by applicable law.
Agreed and Acknowledged, this _____day of _______, 2000.
_______________________________________________(signature)
_______________________________________________(print or type name)
Distribution: Original to Customer
cc: Innovex Field Manager
cc: Sales Representative
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