Exhibit 10.34
MASTER SERVICES AGREEMENT
This Master Services Agreement (this "Master Agreement"), with an Effective Date
of July 31, 2002, will set forth the terms and conditions between Columbia
Laboratories, Inc., 000 Xxxxx Xxxxxx Xxxxxx, Xxxxxxxxxx, XX 00000 (hereinafter
"Columbia"), and Innovex LP, 00 Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxxx, XX 00000
(hereinafter "Innovex").
BACKGROUND:
A. Columbia is in the business of developing, manufacturing,
and distributing pharmaceutical products for women's health care, including
Prochieve(TM) 4% Progesterone Gel, Prochieve(TM) 8% Progesterone Gel,
Advantage-S(R) Bioadhesive Contraceptive Gel, and RepHresh Vaginal Gel(TM)
("Columbia Product(s)"). Innovex is in the business of providing sales,
marketing and alternative commercialization services for the pharmaceutical,
healthcare and biotechnology industries.
B. Columbia and Innovex desire to enter into this Master
Agreement to provide the terms and conditions upon which Columbia may engage
Innovex and its corporate Affiliates from time-to-time to provide contract sales
services for the Columbia Products 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 "Bioadhesive Delivery System" shall mean Columbia's
proprietary and patented drug delivery systems.
1.3 "FDA" shall mean the US Food and Drug Administration.
1.4 "Fees" shall mean the compensation payable to Innovex by
Columbia in return for Services. Fees shall not include
Pass-Through Expenses.
1.5 "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 the
express terms of a Work Order.
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1.6 "Project" shall mean the complete task or set of tasks
described in a specific Work Order.
1.7 "Services" shall mean the responsibilities, obligations and
activities which are to be performed by Innovex, as they are
described in this Agreement and in specific Work Orders.
1.8 "Term" and "Project Term" shall have the meanings described in
Section 11.1.
1.9 "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 and hiring of
sales personnel, full-time or flex-time sales force services,
promotional education programs and other related commercialization
services, when requested by Columbia and agreed to by Innovex as set
forth in the relevant Work Order. Columbia 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"). The first
Work Order is of even date hereof and subsequently issued Work Orders
may follow, or differ materially from, the same basic template. Each
Work Order may include, as appropriate, identification of the Columbia
Products to be involved in the Services, a schedule of Innovex
Responsibilities and Obligations, Columbia 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 Columbia and Innovex in form acceptable to both parties.
3. PAYMENT OF FEES AND PASS-THROUGH EXPENSES.
3.1 Columbia 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 Columbia monthly for the Fees and
Pass-Through Expenses relating to the Project. Each
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invoice shall be supported by a detailed expense report, and supporting
documentation. Notwithstanding the foregoing, Innovex will use its best
efforts to audit expense reports submitted by its Sales Force (prior to
submitting monthly expenses to Columbia) to ensure the expenses detailed
in such expense reports were appropriately incurred in support of the
Services to Columbia. Columbia shall make payment within 30 days after
the receipt of each monthly itemized invoice. If any portion of an
invoice is disputed, Columbia shall pay the undisputed amounts within
the aforementioned 30 days, and the parties shall use good faith efforts
to reconcile the disputed amount for payment as soon as practicable.
3.2 If the period of non-payment of an undisputed amount exceeds 45 days
from the date of receipt of the invoice, Innovex may, at its sole
discretion and without prejudice to any other rights or remedies, give
Columbia a ten (10) day written notice of intent to suspend Services in
connection with the Project, and if the non-payment continues after the
ten (10) day period, Innovex may (i) suspend the Services on that
Project or (ii) exercise its right to give notice of a default in
accordance with Section 11.3.
3.3 Payments shall be by wire-transfer or by check as follows:
Innovex LP
Accounting Number: 511-4454518
ABA Number: 053 101 121
Branch Banking & Trust Co., Raleigh, NC
Innovex Federal Employment ID Number is 00-0000000.
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 Columbia 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 seven (7) 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. These restrictions shall not apply to
Confidential Information which: (i) is or becomes public knowledge
(through no fault of the receiving party); (ii) is made lawfully
available to the receiving party by an independent third party; (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 (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, 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
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respect to such Confidential Information and, thereafter, the receiving
party discloses only the minimum Confidential Information required to be
disclosed in order to comply.
4.2 Innovex and Columbia 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. Upon receipt of a
request from either party, each party shall return all Confidential
Information of the other within thirty (30) days of such request;
provided, however, that each party can maintain one copy of the other's
confidential information to monitor compliance with the confidentiality
terms of this Master Agreement, to satisfy regulatory requirements or to
resolve disputes regarding the Services.
4.3 All Columbia patents, trade secrets, copyrights, trade names,
trademarks, service marks, proprietary materials or intellectual
property and all improvements to any of the foregoing (collectively
"Columbia Property") used in connection with the Services provided
pursuant to this Master Agreement or any Work Order shall remain the
sole and exclusive property of Columbia, and Innovex's rights to use
such Columbia Property shall be limited to those permitted by this
Master Agreement or any Work Order. Columbia and Innovex agree that any
Columbia Property or improvements thereto which are used, improved,
modified or developed by Columbia under or during the term of this
Master Agreement or any Work Order are the sole and exclusive property
of Columbia.
4.4 Columbia 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), the Innovex Build-A-Call(R)
Pharmaceutical Selling Skills System, and the Innovex Sample
Accountability System, which have been independently developed by
Innovex (collectively "Innovex Property"). Columbia and Innovex agree
that any Innovex Property or improvements thereto which are used,
improved, modified or developed by Innovex under or during the term of
this Master Agreement or any Work Order are the sole and exclusive
property of Innovex.
4.5 No public announcement or other disclosure to any third party concerning
the existence, or terms, of this Master Agreement, the Investment and
Royalty Agreement, the Stock Purchase Agreement, the Work Order, and any
other document or agreement executed in connection with this transaction
(the "Transaction Documents") shall be made, either directly or
indirectly, by any party hereto, except as may be legally required or as
may be required for financial reporting purposes, without first
obtaining the written approval of the other party and agreement upon the
nature and text of such announcement or disclosure. Each party agrees
that it shall cooperate fully with the other with respect to all
disclosures regarding the Transaction Documents to the Securities
Exchange Commission and any other governmental or regulatory agencies or
any third party, including requests for confidential treatment of
proprietary information of any party included in any such disclosure.
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4.6 Columbia shall have and retain sole and exclusive right, title and
interest in and to all inventions, discoveries, formulae, writings,
trade secrets, know-how, methods, practices, procedures, processes,
techniques, engineering information, marks, designs, devices,
improvements, manufacturing information and other technology, whether or
not patentable, trademarkable or copyrightable, and any patent
applications, patents, trademarks or copyrights based thereon
("Inventions"), whether or not patentable, that are made, discovered,
conceived, reduced to practice or generated by Columbia (or its
employees or representatives) or by Innovex's employees or Agents that
in any way relate to the Columbia Products or the Bioadhesive Delivery
System or to the marketing or sales of Columbia Products in particular
(as opposed to relating to the marketing or sales of pharmaceutical
products generally). Innovex's employees or Agents will promptly
disclose to Columbia, or any person designated by it, all Inventions. At
Columbia's expense, Innovex's employees or Agents will assist Columbia
in every reasonable manner to obtain and, from time to time, to enforce
patents on said Inventions in any and all countries and will execute all
documents Columbia may desire for such purpose, together with any
assignments of such patents to Columbia or persons designated by it.
4.7 Innovex's employees or Agents hereby irrevocably transfer and assign to
Columbia full ownership of the copyrights in the work created pursuant
to this agreement ("Work"). Columbia shall have all rights, title, and
interest in and to the Work, including the sole and exclusive right to
secure and own the copyright registrations and renewals throughout the
world. Accordingly, this agreement will constitute an assignment of
copyrights in the Work and Innovex's employees or Agents agreement to
cooperate with Columbia and execute any and all other documents
appropriate to evidence sole proprietary rights and copyrights in the
Work to Columbia. On termination of this Agreement for any reason,
Innovex will transfer, assign, and make available to Columbia all text
and other materials, regardless of their stage of development, that
Innovex's employees or Agents have created or prepared on behalf of
Columbia.
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 Columbia and any
employee of Innovex. All persons performing Services shall be employees
of Innovex, or subcontractors engaged by Innovex with prior consent of
Columbia, and shall not be entitled to any benefits applicable to
employees of Columbia.
5.3 Innovex will, among other things, (i) maintain all necessary personnel
and payroll records for Innovex employees; (ii) compute wages and
withhold applicable Federal, State and local
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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.
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. Columbia 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, without limitation: (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) administration of systems for
time-keeping, payroll and employee expense reimbursement; and (iv) day
to day management of employment issues in connection with performance of
the Services.
5.5 Innovex agrees that it controls the work site and the scheduling of its
employees. Innovex will not violate any applicable law pertaining to the
payments of wages to its employees. Innovex is responsible for and
hereby agrees to comply with the following: (i) all rules and
regulations governing the reporting, collection and payment of federal
and state payroll taxes on wages paid to Innovex's employees, including,
but not limited to (a) federal income tax withholding provisions of the
Internal Revenue Code; (b) state and/or local income tax withholding
provisions, if applicable; (c) Federal Insurance Contribution Act
(FICA); (d) Federal Unemployment Tax Act (FUTA) and (e) applicable state
unemployment tax provisions (SUTA); (ii) applicable workers'
compensation laws including, but not limited to: (a) procuring workers'
compensation insurance; (b) completing and filing all required reports;
and (c) administering, managing and otherwise processing claims and
related procedures; (iii) Internal Revenue Code Section 4980B (COBRA);
(iv) the Consumer Credit Protection Act, Title III; and (v) all rules
and regulations governing administration, procurement and payment of all
other employee benefits specified in a Work Order or covered by this
Master Agreement.
6. REGULATORY COMPLIANCE.
6.1 In carrying out their responsibilities under this Master Agreement and
each Work Order, Innovex and Columbia 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.
[sec]1320a-7b(b)), and the Prescription Drug Marketing Act.
6.2 If Innovex or its employees become aware of adverse drug experience
reports involving the use of any Columbia Product, while performing any
Services in connection with the
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Columbia Product, they shall immediately notify Columbia in accordance
with Columbia procedures in place from time to time. Columbia shall
deliver to Innovex a written copy of such Columbia notification
procedures.
6.3 Columbia shall be solely responsible for responding to any government or
regulatory agency concerning use or marketing of Columbia 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 Columbia of any information Innovex receives regarding
any threatened or pending action by a government or regulatory agency
that may affect the Columbia Products. Innovex shall, at the request of
Columbia, cooperate with Columbia 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 Columbia, unless
compelled to do so by law.
6.4 Innovex certifies that neither Innovex nor any Innovex employee or Agent
has been debarred under Section 306(a) or (b) of the Federal Food, Drug
and Cosmetic Act and no debarred person will in the future be employed
by Innovex in connection with any work to be performed for or on behalf
of Columbia. If at any time after execution of this Agreement, Innovex
becomes aware that Innovex or an Innovex employee or Agent is, or is in
the process of being, debarred, Innovex hereby certifies that it will so
inform Columbia immediately.
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 Columbia 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 COLUMBIA MATERIALS.
Within thirty (30) days after the completion of Services by Innovex, or
upon termination of the Master Agreement or any Work Order, Confidential
Information, Columbia Property and other data owned by Columbia,
regardless of the method of storage or retrieval, shall at Columbia's
request either be delivered to Columbia in such form as is then
currently in the possession of Innovex, or disposed of, at the direction
and written request of Columbia, unless such materials are otherwise
required to be stored or maintained by Innovex as a matter of law or
regulation. Columbia shall pay the 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, to be
used to satisfy regulatory requirements or to resolve disputes regarding
the Services.
9. INDEMNIFICATION AND LIABILITY LIMITS.
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9.1 Innovex shall indemnify, defend and hold harmless Columbia, 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; (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, (iv) actions or incidents by
Innovex of criminal or dishonest activity or such actions or incidents
of its employees of which Innovex could have reasonably anticipated, (v)
with respect to the Sales Force, those costs attendant to the
administration of any collective bargaining agreement, and any
liabilities or claims against Columbia arising out of Innovex's
non-payment or payment to or participation in a labor organization's
health and welfare retirement or other benefit fund, including the
cessation of payment thereto or withdrawal from participation therein
(unless such are caused by the actions or inactions of Columbia); (vi)
violations by Innovex of employment-related matters with respect to
Innovex's employees, including matters arising under local, state and/or
federal right-to-know laws, environmental laws, NLRB, OSHA, EEOC, ADA
(including without limitation those relating to employment, public
access and public accommodation), WARN, FMLA, ERISA, all laws governing
wages and hours (including without limitation: prevailing wage rate;
exempt and non exempt status; child labor; and minimum wage and overtime
matters), all laws governing race, sex, sexual harassment, retaliation,
religion, veteran status, national origin, color, age, disability, and
marital status, disclosed and undisclosed benefit plans, all other labor
laws; in each case except to the extent such Losses are determined to
have resulted from the negligence or willful misconduct of Columbia or
its employees.
9.2 Columbia 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 Products by Columbia or
its agents; (ii) breach by Columbia or its employees of its obligations
hereunder; (iii) willful misconduct or negligent acts or omissions of
Columbia or its employees; and (iv) violation by Columbia or its
employees of any municipal, county, state or federal laws, rules or
regulations applicable to the performance of Columbia's obligations
under this Master Agreement or any Work Order; in each case 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: (a) give the party obligated to indemnify (the "Indemnifying
Party") prompt written notice of any such claim or law suit (including a
copy thereof); (b) cooperate fully with Indemnifying Party and its legal
representatives in the investigation and defense of any matter the
subject of indemnification; and (c) not unreasonably withhold its
approval of the settlement of any such claim, liability, or action by
Indemnifying Party covered by this Indemnification provision; provided,
however, that Indemnified Party's failure to comply with its obligations
pursuant to
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this Section 9.3 shall not constitute a breach of this Master Agreement
nor relieve Indemnifying Party of its indemnification obligations
pursuant to Section 9, except to the extent, if any, that Indemnifying
Party's defense of the affected claim, action or proceeding actually was
materially impaired thereby.
9.4 Neither party, nor its Affiliates, nor any of a party's or its
Affiliate's directors, officers, employees, subcontractors or agents
shall have any liability of any type to the other (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 Services performed
by Innovex hereunder.
9.5 Innovex shall not be liable to Columbia for claims or losses arising out
of the statements or representations of Innovex employees with respect
to Columbia Products to the extent the statements or representations
conform to the written or printed statements or representations made to
Innovex and Innovex employees by Columbia with respect to the Columbia
Products.
10. INSURANCE.
10.1 Innovex shall, at its own cost and expense, obtain and maintain in full
force and effect, 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.
10.2 Columbia shall, at its own cost and expense, obtain and maintain in full
force and effect, 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 it has
employees; (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; and (iv) products
liability insurance covering the Products, with a minimum limit of [***]
($[***]).
10.3 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) days 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.
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11. TERM AND TERMINATION.
11.1 This Master Agreement shall commence on the Effective Date 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 Columbia may terminate this Master Agreement without cause at any time
during the Term of the Master Agreement on 120 days prior written notice
to Innovex; provided however, notwithstanding such termination, the
terms of this Master Agreement shall remain in full force and effect
with regard to any existing Work Order until the expiration of such Work
Order according to its terms. An individual Work Order under this Master
Agreement may be terminated as set forth therein.
11.3 Either party may terminate this Master Agreement by written notice at
any time if the other party defaults in the performance of its material
obligations under the Master Agreement. Either party may terminate a
Work Order by written notice at any time if the other party defaults in
the performance of its material obligations under the Work Order. 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. Provided, however, that if the nature of the default is
such that it cannot reasonably be cured within thirty (30) days, the
defaulting party may cure such default by commencing in good faith to
cure such default promptly after its receipt of such written notice and
prosecuting the cure of such default to completion with diligence and
continuity within a reasonable time thereafter. 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, 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,
Columbia shall (a) pay to Innovex all Fees for Services rendered 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 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 Columbia
arising under this Master Agreement or a Work Order, and all provisions
which expressly or by implication survive the
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termination or expiration of the Master Agreement or a Work Order shall
remain in full force and effect.
11.7 Either party may terminate this Master Agreement by written notice to
the other party upon thirty (30) days written notice if no current,
active Work Order is in place between the parties.
12. RELATIONSHIP WITH AFFILIATES.
12.1 Columbia agrees that Innovex may utilize the Services of its corporate
Affiliates to fulfill Innovex's obligations under this Master Agreement
and any Work Order. 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 Columbia and Innovex acknowledge that certain Affiliates of Columbia may
utilize the services of Innovex (and its Affiliates) under this Master
Agreement and under any Work Order. In such event, (i) Columbia shall
cause such Columbia Affiliate to acknowledge and be bound by all the
terms and conditions of this Master Agreement and the specific Work
Order, and (ii) Columbia shall remain responsible and obligated under
this Master Agreement and the Work Order, as if Columbia was directly
receiving the Services provided to such Columbia Affiliate. Any such
Affiliate of Columbia 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 Columbia Affiliate was a
party to this Master Agreement.
13. COOPERATION.
All data and information in Columbia's possession or control necessary
for Innovex to conduct Project assignments will be delivered by Columbia
to Innovex. Innovex shall not be liable to Columbia 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 Columbia'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.
Neither party shall be liable to the other for delay or failure in the
performance of the obligations on its part contained in this Agreement
if and to the extent that such failure or
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delay is due to circumstances beyond its control which it could not have
avoided by the exercise of reasonable diligence including but not
limited to: act of God, war or insurrection; civil commotion;
destruction of essential facilities or materials by earthquake, fire,
flood or storm; act of government, labor disturbance (whether or not any
such labor disturbance is within the power of the affected party to
settle); epidemic; or other similar event; provided, however, that the
party so affected shall notify the other party promptly should such
circumstances arise, giving an indication of the likely extent and
duration thereof, and shall use all commercially reasonable efforts to
avoid, remove or alleviate such causes of non-performance and shall
resume performance of its obligations hereunder with the utmost dispatch
whenever such causes are removed. In the event of force majeure lasting
more than three (3) months, the parties agree to meet and discuss how
this Agreement can be justly and fairly implemented under the
circumstances and if the parties are unable to agree upon how the
Agreement can be implemented then either party may terminate the
Agreement upon thirty (30) days written notice.
15. REVIEW OF WORK; AUDIT.
During the term of this Master Agreement and six (6) months thereafter,
Innovex will permit Columbia's representative(s) (unless such
representatives are competitors of Innovex), at reasonable times and in
a reasonable manner, and at Columbia'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.
If to Innovex: Innovex LP
c/o President, 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 Company
00 Xxxxxxxxx Xxxx
Xxxxxxxxxx, XX 00000
Fax: 000-000-0000
If to Columbia: Columbia Laboratories, Inc.
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000 Xxxxx Xxxxxx Xxxxxx,
Xxxxxxxxxx, XX 00000
Attention: President
Fax: 000-000-0000
With a copy to: Columbia Laboratories, Inc.
000 Xxxxx Xxxxxx Xxxxxx,
Xxxxxxxxxx, XX 00000
Attention: General Counsel
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.
18.1 Resolution of disputes concerning any aspect of the Services, this
Master Agreement or a Work Order, excluding termination, shall be
accomplished by good faith negotiations between Columbia 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 within 30 days following the end of such
30 day period, by binding arbitration, which shall not interfere with
the timely rendering of Services. The arbitration panel will be composed
of three arbitrators, one of whom will be chosen by Columbia, one by
Innovex, and the third by the two so chosen. If both or either of
Columbia or Innovex fails to choose an arbitrator or arbitrators within
fourteen (14) days after receiving notice of commencement of
arbitration, or if the two arbitrators fail to choose a third arbitrator
within fourteen (14) days after their appointment, the American
Arbitration Association shall, upon the request of both or either of the
parties to the arbitration, appoint the arbitrator or arbitrators
required to complete the panel. The arbitrators shall have reasonable
experience in the matter under dispute. The decision of the arbitrators
shall be final and binding on the parties, and specific performance
giving effect to the decision of the arbitrators may be ordered by any
court of competent jurisdiction. Nothing contained herein shall operate
to prevent either party from asserting counterclaim(s) in any
arbitration commenced in accordance with this agreement.
18.2 The arbitration shall be filed with the office of the American
Arbitration Association ("AAA") located in New York, New York or such
other AAA office as the parties may agree upon (without any obligation
to so agree). The arbitration shall be conducted pursuant to the
Commercial Arbitration Rules of AAA as in effect at the time of the
arbitration hearing, such arbitration to be completed in a sixty (60)
day period. In addition, the following rules and procedures shall apply
to the arbitration.
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18.3 The arbitrators shall have the sole authority to decide whether or not
any Dispute between the parties is arbitrable and whether the party
presenting the issues to be arbitrated has satisfied the conditions
precedent to such party's right to commence arbitration.
18.4 The decision of the arbitrators, which shall be in writing and state the
findings of facts and conclusions of law upon which the decision is
based, shall be final and binding upon the parties, who shall forthwith
comply after receipt thereof. Judgment upon the award rendered by the
arbitrator may be entered by any competent court. Each party submits
itself to the jurisdiction of any such court, but only for the entry and
enforcement to judgment with respect to the decision of the arbitrators
hereunder. The arbitrators shall have the power to grant all legal and
equitable remedies (including, without limitation, specific performance)
and award compensatory damages provided by applicable law, but shall not
have the power or authority to award punitive damages. No party shall
seek punitive damages in relation to any matter under, arising out of,
or in connection with or relating to this Agreement in any other forum.
18.5 The parties shall bear their own costs in preparing for and
participating in the resolution of any Dispute and the costs of the
arbitrator(s) shall be equally divided between the parties; provided,
however, that each party shall bear the costs incurred in connection
with any Dispute brought by such party that the arbitrators determine to
have been brought in bad faith.
19. ADDITIONAL WARRANTIES AND REPRESENTATIONS.
19.1 Innovex and Columbia 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 Columbia agree to perform their obligations hereunder in a
timely, professional and competent manner.
19.3 Columbia warrants and represents that it possesses good title to, or the
right to use, any and all trademarks of the Columbia Products, free and
clear of any claims or encumbrances that would impede the performance by
either party under the terms of this Agreement or any Work Order. In
addition, Columbia owns or controls the patents or appropriate licenses
in connection with all Columbia Products to be involved in the Services,
and has no knowledge of the existence of any claim or adverse rights
which would restrict or prevent Columbia or Innovex from performing the
Services pursuant to this Master Agreement or a Work Order.
19.4 Innovex represents and warrants that there are no collective bargaining
agreements binding upon Innovex affecting its employees who are or may
provide Services under this Master Agreement or the Work Order, and that
there are no pending or threatened organizing efforts affecting the
same.
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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 The rights and obligations of Columbia and Innovex under this Master
Agreement and any Work Order, which by intent or meaning have validity
beyond such termination (including, but not limited to, rights with
respect to confidentiality, mutual indemnification and liability
limitations) shall survive the termination of this Master Agreement or
such Work Order.
20.3 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. 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.
20.4 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.
20.5 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.
20.6 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 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.
20.7 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.
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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 COLUMBIA LABORATORIES, INC.
by: Innovex America Holding
Company, its General Partner
By: /S/ Xxxxx X. Overs By: /S/ Xxxx Xxxxxxxxx
------------------ ------------------
Name: Xxxxx X. Overs Name: Xxxx Xxxxxxxxx
-------------- --------------
Title: CFO Title: President & CEO
--- ---------------
Date: 7/30/02 Date: 7/30/02
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SALES FORCE WORK ORDER # 8795
EFFECTIVE DATE OF WORK ORDER: July 31, 2002
This Sales Force Work Order is entered into between Columbia Laboratories, Inc.,
("Columbia") and Innovex LP ("Innovex"), pursuant to the Master Services
Agreement, having an Effective Date of July 31, 2002, between Columbia and
Innovex, and is subject to all the terms and conditions set forth therein,
except as may be otherwise expressly provided herein.
A. BRIEF DESCRIPTION OF SALES FORCE PROJECT:
----------------------------------------
Sales Force
-----------
A full time 50 - 60 person sales force with 5 managers will be assigned to
selling Procheive 8%, Prochieve 4%, RepHresh, and Advantage-S to a selected list
of approximately [***] gynecologists. Procheive 8% will be in first position,
followed by Prochieve 4%, RepHresh and Advantage-S. The sales force will be on a
four-week cycle (12 cycles a year). Columbia's objective is to maximize the
quality of the calls and to work the office to support the Columbia product
line.
Sales Training
--------------
A modular sales training program is planned. The objective of this first module
is to instruct the representatives in basic reproductive physiology, disorders
associated with infertility and commonly used therapies and procedures. Self
administered exams will be completed by each representative and returned to
confirm that the sales force has basic knowledge of infertility. The second
module will provide product knowledge. A self-administered exam will be returned
to Columbia to confirm that the sales force has basic product knowledge. The
third and last home study module will deal with [***]. A self-administered exam
on this learning will be returned promptly. A national sales meeting will be
held within six weeks of project start. A week prior to the national meeting,
managers will meet to ensure that they are trained to evaluate and assist in the
training of the representatives.
The first order of business at the national sales meeting will be an exam to
demonstrate that the sales force is up to speed, followed by two days extensive
group training, two days of training in smaller groups, and one day designated
for Innovex training regarding personnel management, compensation and benefits
and field administration. Following the national sales meeting, the sales force
should hit the ground running. Through e-mail, Columbia will provide updated
information at a minimum on a monthly basis. Each manager will be responsible
for evaluating each sales person in their region each cycle to ensure they are
properly trained to handle this assignment.
Selling Material
----------------
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Each Visual Aid will be used for [***]cycles meaning that there will be
[***]visual aids per year. When a new visual aid is delivered to the sales
force, it will be accompanied by appropriate training material to ensure that
the representative will use it properly.
As part of their assignment, the sales force will spend time with the practice
nurse to make sure that s/he has the tools to help women follow the regimen. A
special web site will be created to answer questions by the gynecologist, the
staff and women as a means of providing information instantaneously. The sales
force will encourage physicians and their staff to visit it.
The Physician Experience Trial
------------------------------
The Sales Force will be responsible for implementing a physician experience
trial to be designed by Columbia.
B. PROJECT TEAMS:
--------------
Columbia Contact Person: Xxxx Xxxxxxxxx
President and CEO
address: 000 Xxxxx Xxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
phone: 000-000-0000
fax: 000-000-0000
Innovex Contact Person: Xxx XxXxxxx
VP of Speciality Sales
address: 00 Xxxxxxxxx Xxxx.
Xxxxxxxxxx, XX 00000
phone: 000-000-0000 x0000
fax: 000-000-0000
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.
C. PROJECT TERM AND KEY DATES:
---------------------------
--------------------------------------------------------------------------------
Project Start Date July 31, 2002
--------------------------------------------------------------------------------
District Manager Start Date August 8, 2002
--------------------------------------------------------------------------------
Sales Representative Start Date August 26, 2002
--------------------------------------------------------------------------------
Home Study August 26 - 31, 2002
--------------------------------------------------------------------------------
Initial In-Class Training Dates Sept. 23 - Oct. 1, 2002
--------------------------------------------------------------------------------
Last Sales Representative Field Day July 31, 2005
--------------------------------------------------------------------------------
Project End Date July 31, 2005
--------------------------------------------------------------------------------
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"Project Term" shall mean the period of time beginning on the Project Start Date
and ending on the Project End Date.
D. DEFINITIONS
-----------
1. "Day Worked" shall mean a day during which a Sales Representative
details or presents to 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 or
vacations.
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 a Prochieve
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. "Off-limits Prescriber" shall mean one of the specifically identified
Prescribers within a Sales Representative's territory that the Sales
Representative is prohibited from contacting.
4. "Prescriber" shall mean, in the case of pharmaceutical products,
physicians and other health care professionals legally authorized to
write prescriptions for pharmaceutical products and, in the case of
medical devices, physicians and other health care professionals.
5. "Presentation" shall mean an interactive face-to-face contact by a Sales
Representative with a Prescriber or the Prescriber's staff, during which
a promotional message involving a RepHresh or Advantage-S Product is
given in accordance with the Promotional Program. When used as a verb,
"present," "presents" and "presented" shall mean to engage in a
Presentation as defined herein.
6. "Product" shall mean, individually and collectively, Prochieve(TM)4%
Progesterone Gel, Prochieve(TM)8% Progesterone Gel,
Advantage-S(R)Bioadhesive Contraceptive Gel, and RepHresh Vaginal
Gel(TM).
7. "Promotional Expense Budget" shall mean the funding and guidelines for
use of such funding that are provided by Columbia for use by the Sales
Force when detailing and presenting Product.
8. "Promotional Material" shall mean the Product labeling and package
inserts, sales aids and detailing materials, presentation materials and
other promotional support items provided by Columbia to Innovex, for use
in promotion of the Product.
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9. "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.
10. "Referral Message" shall mean the promotional message, as provided by
Columbia to Innovex from time to time, that any patient who has not
become pregnant after three (3) cycles of treatment using clomiphene
citrate together with 8% progesterone gel should seek care of an
assisted reproductive technology specialist for further treatment.
11. "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 and Presentations of
the Product in accordance with the terms of this Agreement.
12. "Sales Representative" shall mean an Innovex employee who has been
trained and equipped to detail and present to Prescribers.
13. "Target Prescriber" shall mean one of the specifically identified
Prescribers within a Sales Representative's territory to be detailed and
presented to by the Sales Representative.
14. "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.
E. INNOVEX RIGHTS, RESPONSIBILITIES AND OBLIGATIONS
------------------------------------------------
1. Sales Force. The Sales Force will be composed of the following Innovex
employees:
-------------------------------------------------------------------------------
Number Position Title
-------------------------------------------------------------------------------
55 Sales Representatives
-------------------------------------------------------------------------------
5 District Managers
-------------------------------------------------------------------------------
In addition, Innovex will provide appropriate management oversight of
the Sales Force, including that of a National Sales Manager. Columbia
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 maximum ratio of District Managers to Sales Representatives of 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 Columbia elects to participate in
the final selection of members of the Sales Force, Columbia shall
approve or disapprove qualified candidates
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within five (5) business days after each qualified candidate is
submitted to Columbia for final selection. A "qualified candidate" must
meet the Sales Force Qualifications.
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); minimum one year
outside sales experience, preferably within pharmaceuticals and women's
health. At least 40% of Sales representatives shall have a minimum of
one year of pharmaceutical sales experience, of which at least 30% shall
be in women's health. A qualified candidate for District Manager shall
meet the following minimum qualifications: four-year college degree
(B.A., B.S. or equivalent); minimum 2 years outside sales experience,
minimum one year previous management experience in pharmaceutical sales.
4. Position Descriptions and Duties. Innovex shall manage, supervise and
evaluate the performance of the National Sales Manager, 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; Columbia-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
. Avoid all contact whatsoever with Off-limits Prescribers
. Keep current with market knowledge and competitive products
. Avoid any comparison or reference to Crinone(R)(progesterone gel)
products marketed by Serono, Inc.
. Maintain a professional image for Columbia and Columbia Products
. Participate in all training and sales meetings
. Plan and organize territory to meet sales and call targets
. Make sales presentations (Details and Presentations) - individual,
one-on-one, in-services
. Deliver the Referral Message with each sales presentation (Detail)
of Prochieve 8% (progesterone gel)
. Comply with PDMA
. Make complete, accurate and timely submission of all time-keeping,
call activity and expense reports
. Compliance with Promotional Program, and proper use of Promotional
Materials and Promotional Expense Budgets
. Participate or coordinate Lunch & Learns, dinner programs, weekend
events, as appropriate
. Have appropriate interaction with co-promotional partners or
counterparts
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NATIONAL SALES MANAGER, DISTRICT MANAGERS
. Recruit, interview and select Sales Representatives and subordinate
managers
. Handle 120 day and annual 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
reporting.
. Communicate with Columbia 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
. Monitors compliance with Off-limits Prescriber restrictions
. Monitors compliance with Crinone(R) products restrictions
. Monitors delivery of the Referral Message
. Monitors compliance with PDMA
. Monitors time-keeping and attendance
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 Columbia, 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. Innovex shall facilitate the
participation of the Sales Force in Columbia's initial training of the
Sales Force, backfill training of replacement District Managers and
Sales Representatives and all follow-up training, including periodic
sales meetings. Columbia may request Innovex's participation in the
delivery of training and Innovex will provide such services on a time
and materials basis as the parties may agree. In all cases, Innovex
shall monitor and observe all Columbia training. Innovex may have Sales
Force Members participate in the Innovex Leadership Development Program.
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 Columbia. 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
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Columbia. 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 make any untrue or misleading
statements or comments about the Products or any Columbia competitors or
competitor products. Sales Representatives shall be prohibited from (i)
contacting Off-limits Prescribers and (ii) making comparisons or
references to Crinone(R)products.
8. Project Reports. Innovex shall provide Columbia a monthly Project
report, which shall include: (i) headcount, reported nationally, by
region/district; vacancy rates, turnover, personnel transfers to
Columbia, 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. ITMS and Call Reporting. Innovex shall provide the Innovex Territory
Management System, including automated call reporting functions. 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.
11. Management and Discipline of the Sales Force. Innovex shall be
responsible to manage the Sales Force. Innovex has sole authority to
remove employees from the Sales Force. In conformance with Innovex
policy, Innovex shall provide appropriate employee counseling and
discipline, up to and including termination, on its own initiative and
upon the reasonable request of Columbia, to Sales Force members who
violate employment rules and who are otherwise under performing their
job responsibilities. Innovex will promptly follow-up on any reports
made by Columbia of Sales Force member non-compliance and will apply
such counseling or discipline as may be warranted in Innovex's judgement
consistent with Innovex's prior employment practices.
12. Business Cards; Detail Bags. Innovex shall supply the Sales Force with
business cards, the content of which shall be subject to approval by
Columbia, such approval not to be
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unreasonably withheld. Innovex shall supply the Sales Force with detail
bags. Columbia shall provide Innovex with camera ready artwork of
Columbia's logo or other content Columbia wishes to include on the
business cards.
F. COLUMBIA RIGHTS, RESPONSIBILITIES AND OBLIGATIONS
-------------------------------------------------
1. Promotional Program and Promotional Materials. Columbia 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 Columbia
Product. Columbia shall be responsible for providing written guidelines
for proper use of the Columbia's Promotional Expense Budget.
2. Training and Periodic Sales Meetings.
Columbia shall be responsible for the following:
. Programming, materials and facilities for initial Sales Force
training. The initial training agenda shall include one day
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 as designated by Columbia.
Any reasonable, documented and approved expenses incurred by Innovex in
conjunction with Sales Force training shall be a Pass-Through Expense to
Columbia.
3. Sales Data. Columbia shall be solely responsible for obtaining historic
and ongoing sales data regarding Columbia Products. Columbia shall be
solely responsible to pay any applicable per representative fee required
by any third party, except for the fee imposed by the American Medical
Association. Upon execution of this Agreement, Innovex will provide
Columbia with the historic data used to size and structure the Sales
Force. Columbia shall provide Innovex with the data reasonably necessary
to maintain Sales Force effectiveness including but not limited to, (i)
Exponent sales/total Rx data by territory, district, region, and nation;
and (ii) Early view by territory.
4. Sales Force Travel Expenses. Columbia shall be responsible for all Sales
Force travel, lodging and meal expenses, when necessary, documented, and
actually incurred by the Sales Force in the amounts authorized in the
annual Sales Force travel expense budget set forth on Exhibit 2 attached
hereto. Columbia shall have no responsibility for, or obligation to pay
for, travel expenses exceeding the budget without Columbia's consent.
5. No Recruitment. Through the Project End Date and for one year
thereafter, neither party shall attempt to actively recruit or solicit
any personnel of the other party without the prior written consent of
such party; except as otherwise provided herein and provided that,
notwithstanding the foregoing, a party shall be permitted to engage in
general recruitment
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through advertisements or recruiting through head-hunters so long as
Innovex employees and personnel are not specifically targeted.
6. Transfer of Ancillary Services. On or after August 19, 2003, Columbia
may, upon 60 days prior notice to Innovex, assume direct responsibility
for call reporting, sample accountability and reporting, and computers
and support services related to the Sales Force.. Should Columbia assume
such services, it shall remain responsible to pay the monthly fee set
forth in paragraphs (G)(4)&(5) of this Work Order.
G. FEES AND PASS-THROUGH EXPENSES
------------------------------
1. Daily Fees. Columbia shall pay Innovex a Daily Fee for each Day Worked
by Sales Representatives and Field Managers during the Project Term and
thereafter if required for Project close-out. The Daily Fees and total
estimated Daily Fees during the first year of the Project Term are
stated in the following table:
--------------------------------------------------------------------------------------------------------------------
Sales Force Positions Number Daily Rate Estimated Estimated Estimated
Days Worked Total Days Total Fees
Worked
--------------------------------------------------------------------------------------------------------------------
Sales Representatives 55 $[***] [***] [***] $[***]
--------------------------------------------------------------------------------------------------------------------
District Managers 5 $[***] [***] [***] $[***]
--------------------------------------------------------------------------------------------------------------------
Estimated Total Fees $[***]
--------------------------------------------------------------------------------------------------------------------
Effective August 19, 2003, these Daily Rates may be increased by up to
[***]%. Effective August 19, 2004, the then effective Daily Rates may be
increased by up to [***]%.
2. Take-On Fee.
-----------
a. Individual Sales Force Members. Innovex shall charge Columbia a fee
for each Sales Force member that becomes employed by Columbia or an
affiliate during the Project Term, or six months thereafter if
Columbia does not exercise its rollover rights with respect to such
member under paragraph (g)(2)(b); provided however, that Columbia
may only hire a Sales Force member during such period upon providing
Innovex 15 days notice of Columbia's desire to so hire and, in the
case of Sales Representatives only upon Innovex express consent. For
each hire, Columbia shall pay Innovex the following: during the
first, second, and third years of the term, an amount equal to
[***]%,[***]%, and [***]%, respectively of the employee's Innovex
annual salary. These amounts shall be included in Innovex's regular
invoicing.
(i) Use of Take-on Fees. Innovex, in its sole discretion, may make
the fees paid by Columbia under paragraph G(2)(a) available for
the Sales Force retention initiatives as may be warranted and
prudent during the Project Term. The Steering Committee may
make recommendations to Innovex on such expenditures.
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25
b. Sales Force Rollover. Columbia may hire directly [***]% or more of
the Sales Force contemporaneously with the Project End Date by
providing Innovex 90 days notice and without any payment to Innovex,
whatsoever.
3. Incentive Plan Administration. Columbia shall pay Innovex an amount
equal to (i) the amount of all non-salary compensation earned by Sales
Force members in accordance with the terms of the Incentive Plan or
otherwise requested by Columbia; and (ii) an amount equal to [***]% of
such compensation for Innovex's employer costs (payroll taxes,
benefits).
4. ITMS Fees. For Innovex's provision of ITMS Services as set forth in
paragraph E(10) of this Work Order, Columbia shall pay a monthly service
fee in the amount of $[***] per Sales Representative, District Manager
and the National Sales Manager through the Project End Date.
5. Payment Schedule. Innovex shall send Columbia an estimated cost for each
month ten (10) days in advance, including all incentive compensation and
related employer costs. Columbia shall pay the estimated monthly charge
on the first day of the month by wire transfer to the account designated
by Innovex. At the end of each calendar month Innovex shall provide
Columbia a list of the billable Sales Force personnel and the total
number of Days Worked multiplied by the respective Daily Fee rate and
all Fees, Take-on Fees and Pass-Through Expenses. Innovex shall add any
underpayment to, and deduct any overpayment from, the next estimate sent
to Columbia. The parties shall use good faith efforts to reconcile any
disputed amount as soon as practicable. One half of any amount in
dispute for more than 30 days shall be credited against the next
estimate (provided the amount in dispute was paid by Columbia based on a
previous estimate) sent to Columbia and remain as a credit until the
dispute is resolved.
6. Initial Payment. Upon the execution of this Agreement, Columbia shall
make an immediate payment to Innovex in the amount of $ [***], to be
credited against the first estimated payments due to Innovex.
7. Changes in Scope; Additional Services. All prices and costs contained in
this Work Order are subject to revision as needed to reflect changes in
the scope of services being provided by Innovex. Additional services
will be provided at Innovex's normal and customary rates.
8. Expense Allocation Chart. The financial responsibility of Innovex and
Columbia 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).
H. ADDITIONAL TERMS
----------------
1. Steering Committee. Columbia shall make all decisions with respect to
the strategy for the marketing and Promotion of the Products. However,
other issues may arise under the terms of this Agreement or between the
parties while operating under this Agreement which are
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appropriate for consultation between the parties to ensure maximum
productivity of the Sales Force, including, but not limited to, the
establishment of work rules or the response to greater than expected
Sales Force turnover and other changing market conditions. The parties
shall, therefore, establish a Steering Committee, chaired by Columbia
and consisting of up to three (3) members from each party. The
chairperson's duties shall include site selection, logistics, agenda and
facilitation; provided however, that a Innovex Committee member may
submit agenda items to the Chair and such items shall be included in the
next regular meeting of the Steering Committee. Each member of the
Committee shall be an employee or member of the Board of Directors of
the party that appointed such member. Initial appointments shall be made
within fourteen (14) days of the date of this Agreement. A member of the
Committee may be removed at any time, with or without cause, by the
party that appointed such member. The Committee shall meet each quarter,
or otherwise at the call of the chairperson to review, coordinate, and
discuss issues regarding the Promotional Program. In addition, the
Committee shall review and resolve issues pertaining to this Agreement.
The members of the Committee will use reasonable efforts to reach
consensus on all decisions.
In Witness Whereof, Columbia and Innovex have caused this Work Order # 8795 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:
COLUMBIA LABORATORIES, INC. INNOVEX LP
by: Innovex America Holding
Company, its General Partner
/S/ Xxxx Xxxxxxxxx /S/ Xxxxx X. Overs
------------------ ------------------
By: Xxxx Xxxxxxxxx By: Xxxxx X. Overs
Title: President & CEO Title: CFO
Date: 7/30/02 Date: 7/30/02
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ATTACHMENT A TO SALES FORCE WORK ORDER
SALES FORCE EXPENSE ALLOCATION
------------------------------
JULY 2002
PROJECT # 8795
----------------------------------------------------------------------------------------------------------------------------
Category Innovex PassThrough Columbia
Direct Expenses Direct
Expenses Expenses
----------------------------------------------------------------------------------------------------------------------------
Salary, including payroll taxes, for Sales Representatives, District X
Managers, National Sales Manager
----------------------------------------------------------------------------------------------------------------------------
Incentive compensation (bonus) for Sales Representatives, District X
Manager, and National Sales Manager, plus [***]%
----------------------------------------------------------------------------------------------------------------------------
Benefits package, including (401k), ESOP, ESPP, medical, dental, X
Rx, vacation, holidays
----------------------------------------------------------------------------------------------------------------------------
Auto Costs in territory, including monthly allowance, mileage X
reimbursement, parking and tolls.
----------------------------------------------------------------------------------------------------------------------------
Basic Business Expenses in territory, including phone, X
paper supplies, postage and voice mail.
----------------------------------------------------------------------------------------------------------------------------
Business Cards & Detail Bags X
----------------------------------------------------------------------------------------------------------------------------
Call Reporting ; ITMS X
----------------------------------------------------------------------------------------------------------------------------
Computers for Sales Representatives, including software, helpdesk X
support, data/replication lines
----------------------------------------------------------------------------------------------------------------------------
Computers for DMs, 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 X
and motor vehicle checks
----------------------------------------------------------------------------------------------------------------------------
Meetings: Columbia 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
----------------------------------------------------------------------------------------------------------------------------
Training program, materials and facilities; initial and follow-up X
----------------------------------------------------------------------------------------------------------------------------
Travel Expenses (air, hotel, meals, T&E) for Sales Reps, District X
Managers, National Sales Manager X
*Interviewing X
*Training X
*Territory travel for field management purposes X
----------------------------------------------------------------------------------------------------------------------------
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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 Columbia and Innovex LP, dated as of
July 31, 2002, and Work Order/Sales Force # 8795, dated as of July 31, 2002.
--------------------------------------------------------------------------------------------------------
PART 1 To be completed by Columbia
Attach any relevant, helpful information
--------------------------------------------------------------------------------------------------------
NUMBER OF SALES REPRESENTATIVES
REQUESTED
--------------------------------------------------------------------------------------------------------
TERRITORY LOCATION(S)
--------------------------------------------------------------------------------------------------------
REQUESTED START DATE
--------------------------------------------------------------------------------------------------------
AUTHORIZED COLUMBIA 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 shall begin immediately:
Request Form was Received by Innovex
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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EXHIBIT 2 TO SALES FORCE WORK ORDER
ANNUAL TRAVEL BUDGET
7/31/02 - 9/17/03 ("Year One"):
$[***] for Initial Sales Force Training
$[***] for POA Meetings and Field Based Travel
9/18/03 - 9/17/04 ("Year Two"):
Year One budget plus [***]%
9/18/04 - 10/14/05
Year Two budget plus [***]%
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