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EXHIBIT 10.62
AGREEMENT
This AGREEMENT ("Agreement") is dated as of October 24, 2000 by and
between Cardinal Health Sales and Marketing Services ("Vendor"), a division of
XxxXxx, Inc., an Ohio corporation, with its principal place of business at 0000
Xxxxxxxx Xxxxx, Xxxxxx, Xxxx, and Guilford Pharmaceuticals Inc. ("Company"), a
Delaware corporation having a principal place of business at 0000 Xxxxxxxxx
Xxxxxx, Xxxxxxxxx XX 00000.
BACKGROUND INFORMATION
Company develops, distributes and sells pharmaceutical products, and
Vendor provides medical representatives who Detail (as hereinafter defined)
pharmaceutical products for third parties. The Company desires Vendor to provide
representatives to Detail certain products as determined and directed by Company
in the Territory (as hereinafter defined), pursuant to the terms and conditions
of this Agreement, and Vendor desires to provide the Representatives and perform
such services pursuant to the terms and conditions set forth in this Agreement.
The parties hereby agree as follows:
ARTICLE I
DEFINITIONS AND REFERENCES TO VENDOR
1.1. Definitions. The following terms when used in this Agreement
shall, except where the context otherwise requires, have the following meanings:
(a) "Act" means the Federal Food, Drug and Cosmetic Act,
as amended, and the regulations promulgated thereunder from time to time.
(b) "Affiliate" shall have the definition set forth in
Rule 405 promulgated under the Securities Act of 1933, as amended.
(c) "Agency" means any governmental regulatory authority
in the Territory responsible for granting approvals for the sale or maintaining
regulatory oversight of the Products, including, without limitation, the FDA (as
hereinafter defined).
(d) "Contract Year" means a period of twelve (12)
consecutive months during the term of this Agreement, beginning on the Effective
Date (as hereinafter defined).
(e) "Detail" means an interactive, face-to-face visit by
a Representative with a Target Customer (as hereinafter defined) or his or her
legally empowered designee in the Territory, during which the FDA-approved
indicated uses, safety, effectiveness, contraindications, side effects, warnings
and other relevant characteristics of the Product (as hereinafter defined) is
described by the Representative in a fair and balanced manner consistent with
the requirements of the Act, and using, as necessary or desirable, the Product
Labeling (as hereinafter defined) and the Product Promotional Materials (as
hereinafter defined).
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(f) "Effective Date" means the date this Agreement is
fully executed by both parties.
(g) "FDA" means the United States Food and Drug
Administration and any successor agency having substantially the same functions.
(h) "Manager" means an individual hired by and retained
as an employee of Vendor to supervise activities of Representatives under this
Agreement, including district sales managers, regional sales directors, a
national sales director, and a project manager.
(i) "PDMA" means the Prescription Drug Marketing Act of
1987, as amended, and the regulations promulgated thereunder from time to time.
(j) "Product Detail" means Detail of a Product between
Target Customer and Representative. When used as a verb, "Detail" or "Detailing"
shall mean to engage in a Detail as defined in this Section 1.l(e).
(k) "Product Labeling" means all labels and other
written, printed, or graphic matter provided by the Company including (i) any
container or wrapper utilized with a Product, or (ii) any written material
accompanying a Product, including, without limitation, Product package inserts.
(l) "Product Launch Date" means the first Monday
following completion of the Training Program (as defined in Section 6.1).
(m) "Product Promotional Materials" means all written,
printed or graphic material provided by the Company, including Product Labeling,
intended for use by Representatives during a Detail, including visual aids, file
cards, premium items, clinical studies, reprints, drug information updates and
any other promotional support items that Company deems necessary or appropriate
to conduct the Program. Product Promotional Materials shall include FDA approved
indicated uses, safety, effectiveness, contraindications, side effects, warnings
and other relevant characteristics of each of the Products.
(n) "Products" means the pharmaceutical products to be
detailed by Representatives and marketed by Company as set forth on attached
Schedule 1.1(l) and such other products as may be mutually agreed between the
parties and added to Schedule 1.1(l).
(o) "Program" means the program of Detailing to be
conducted by the Representatives pursuant to this Agreement and during the term
of this Agreement, as defined in Section 14.1.
(p) "Representative" and "Representatives" mean an
individual hired by and retained as an employee of Vendor to conduct Detailing
of Products in connection with the Program. As sometimes used herein,
Representative shall also include Managers.
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(q) "Target" or "Target Customer" means a physician or
other specialist identified by Company.
(r) "Territory" means the geographical area specified in
the attached Schedule 1.1(p).
(s) "Vendor" means Cardinal Health Sales and Marketing
Services, a division of XxxXxx, Inc., an Ohio corporation. References herein to
Vendor shall be deemed to include the Representatives and Managers.
ARTICLE II
APPOINTMENT OF VENDOR; GENERAL SCOPE OF ACTIVITIES
2.1. Furnishing Representatives. Vendor shall recruit and hire,
within twelve (12) weeks after the Effective Date, at least twenty (20), or such
greater number of Representatives (not to exceed thirty (30)) as shall be
designated by Company within five (5) weeks of the Effective Date, to engage in
Product Detail activities in the Territory. Such Representatives shall conform
to the Representatives Profile set forth on Schedule 2.1. Vendor shall assign
Representatives for such Target Customers, in such numbers, and in such
Territories as shall be designated by Company (or recommended by Vendor pursuant
to Section 2.9) during the term of this Agreement. Each Representative shall
make Product Details on his or her assigned Target Customers based on the
general direction given by Company's designated management team and as mutually
agreed to by Vendor. The duties of such Representatives shall be exclusively to
Detail the Products and perform other related activities deemed necessary for
the establishment and maintenance of new and existing customers of the Products
in the Territory defined as set forth on Schedule 1.1(p). Company shall at all
times retain the right to promote the Products by whomever, wherever and to
whomever it chooses.
2.2 Furnishing Managers. Vendor shall recruit and hire Managers to
supervise the activities of Representatives and to perform this Agreement in
such numbers and for such Territories (when relevant) as mutually agreed upon by
Vendor and Company.
2.3. Scope of Activities. The parties shall perform the following
activities as applicable to each in connection with the Program:
(a) Vendor will recruit, interview and hire as its
employees Representatives and Managers conforming to the Representatives Profile
set forth on Schedule 2.1. Vendor shall have the sole authority to reject any
applicant for employment as a Representative or Manager. Company may, at its
sole cost and expense, participate with Vendor in the interviewing of Managers,
and the Company shall have the right to approve the hire of Managers, and may
nominate acceptable Managers for consideration for the Vendor to hire; provided,
however, that in the event Vendor rejects an applicant for Manager and
thereafter hires such applicant at the request of Company, Company shall
indemnify for and hold Vendor harmless from any Damages (as defined in Section
16.1) arising as a result of such Manager's wrongful or negligent acts or
omissions.
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(b) Vendor shall have sole and exclusive authority to
discipline or terminate the employment of Representatives and the Managers.
Company may reasonably request that a Representative or Manager be terminated or
reassigned if such Representative's or Manager's activities or conduct are not
adequately achieving the performance goals of the Product, or if the
Representative or Manager fails to comply with all applicable laws, regulations,
and Company requirements for Detailing the Product. Reassignment in this context
under this Agreement may mean reassignment to another part of the Territory, or
reassignment to another contract sales force for another Vendor account. Vendor
shall use its best efforts to comply with such request; provided that such
action complies with applicable laws and is in accordance with Vendor's policies
and procedures as determined by Vendor. In the event Vendor determines that its
policies and procedures or applicable laws prohibit the termination or
reassignment of any Representative so requested by Company, it shall notify
Company of such determination and submit a corrective action plan for Company
approval.
(c) Vendor shall cause each Representative to attend and
successfully complete the Training Program (as defined in Section 6.1) conducted
jointly by Company or its agents and Vendor for each of the Products prior to
participating in the Program. Any such Representative who shall not successfully
complete all such requirements shall be removed and replaced by another
Representative who shall comply with such requirements.
(d) Vendor shall from time to time and in any case every
six (6) weeks if so requested by Company, beginning with the Product Launch Date
conduct random profiles of activities during the Program consisting of
satisfaction surveys sent to customers with whom Representatives have interacted
and share the results of such profiles with Company on a regular and prompt
basis. Vendor shall reasonably assist the Company should Company decide to
conduct such random profiles itself.
(e) Vendor's District Managers shall, as part of their
activities under this Agreement, routinely accompany Representatives on Details,
conduct field evaluations of the Representatives and the Program, including time
supervision, territory management, and reporting, and be available to review
such evaluations with the Company's coordinator of the Program. At Company's
request, Vendor shall permit Company or its designated representative to review
Vendor's evaluations relating to the foregoing and to accompany the
Representatives on such Details.
(f) Company shall provide Vendor, without cost,
sufficient quantities of the Product Promotional Materials and Product Labeling
for the performance and supervision of Detailing. Company shall be solely
responsible for the preparation, content, and method of distribution of the
Product Promotional Materials and the Product Labeling. In connection with the
Detailing of the Products, the Representatives shall use only the Product
Labeling and the Product Promotional Materials provided by Company; and under no
circumstances shall Vendor or the Representatives develop, create, or use any
other promotional material or literature for the Detailing of the Products.
Company shall advise Vendor immediately of any inaccuracy or incompleteness of
the Product Promotional Materials or the Product Labeling, and upon such notice
Vendor and the Representatives shall immediately cease the use of any portion or
all of the Product Promotional Materials or Product Labeling so identified by
Company.
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(g) Vendor shall instruct the Representatives to limit
their verbal statements and claims regarding the Products, including efficacy
and safety, to those that are consistent with the Product Labeling and the
Product Promotional Materials. The Representatives shall not add, delete, or
modify claims of efficacy or safety in the Detailing of the Products, nor make
any changes (including underlining or otherwise highlighting any language or
adding any notes thereto) in the Product Promotional Materials. Representatives
shall not make any disparaging, untrue, or misleading statements about any of
Company or its Affiliates, employees, competitors, or competing products.
Representatives shall Detail the Products in strict adherence to all applicable
laws, regulations, and professional requirements, including, but not limited to,
the Act, the Medicare and Medicaid Anti-Kickback Statute, and the American
Medical Association Gifts to Physicians from Industry Guidelines.
(h) The Representatives shall remain under the direct
authority and control of Vendor, but shall cooperate with Company and shall
receive advice and direction related to Detail activities on the Products from
Company and Vendor mutually. Company shall make all decisions with respect to
the overall strategy in connection with the Detailing of the Products. Any
Company personnel interacting with Vendor Representatives shall not discipline
the Representatives or implement terms or conditions of employment or personnel
policies and/or practices with respect to the Representatives or otherwise
control the daily activities of Representatives. Company shall use commercially
reasonable efforts to advise Vendor, and to the extent necessary, to share with
Vendor copies of reports, memoranda, and other data relating to Company's
observations or assessment of the Representative's performance under this
Agreement.
(i) Vendor shall supply Representatives and Managers with
fleet vehicles for their use in performing and supervising the Detailing, and
Company shall reimburse Vendor for all of its reasonable, budgeted, documented
out-of-pocket costs related to such vehicles, including but not limited to costs
related to owning, leasing, maintaining, insuring, and/or operating such
vehicles (including fuel costs). Company shall reimburse Vendor for all
reasonable, budgeted, documented out-of-pocket costs and expenses (i.e., airline
tickets and other travel expenses, hotel, rent-a-car, business meals, travel
meals, etc.) of Representatives and Managers in connection with performing
services pursuant to this Agreement. Company and Vendor shall establish a
mutually acceptable budget for the costs and expenses referenced in this
subparagraph for each Territory, and Vendor shall obtain prior approval for any
such costs or expenses that exceed the budget. All such costs and expenses in
excess of such budget shall be for the Vendor's account, unless Company agrees
otherwise.
(j) Company and Vendor shall work together, using their
respective proprietary databases, to establish a database of Target Customers in
the Territory. Company and Vendor shall confer throughout the term of the
Agreement regarding additions to and deletions from the Target Customer
database. Company.
(k) Representatives and Managers shall comply with
Vendor's drug policy, a copy of which is attached hereto and incorporated by
reference herein as Schedule 2.3(k).
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2.4. Orders for Products. Company shall be solely responsible for
establishing the terms and conditions of the sale of the Products, including
without limitation, the price at which the Products will be sold, whether sales
of the Products will be subject to any discounts, the method of distribution of
the Products, and whether any credit will be granted or refused in connection
with the sale or return of any Product. Company shall be exclusively responsible
for accepting and filling all purchase orders for the Products, billing and
returns for the Products, and all other activities in connection with the sale
and delivery of the Products, other than Detailing. If Vendor or the
Representatives receive an order for the Products, they shall immediately
transmit such order to Company for further handling and communications with the
submitter of the order, including acceptance or rejection, which shall be in
Company's sole discretion.
2.5. Representatives' Activity. Subject to Company's obligations
and representations and warranties in this Agreement, any negligent or wrongful
act or omission on the part of the Representatives (both individually and as a
group) that occur during the term of this Agreement and that arise during the
course and within the scope of their employment with Vendor pursuant to this
Agreement shall be deemed to be negligent or wrongful acts or omissions of
Vendor; provided, however, that any acts or omissions of the Representatives
pursuant to the direction, control or supervision of Company or its employees or
agents shall not be deemed to be negligent or wrongful acts or omissions of
Vendor. Wrongful acts or omissions shall include in this context under this
Agreement failure to comply with applicable laws and regulations or Vendor's
policies and procedures or Companies policies and procedures that have been
communicated in writing to Vendor and the Representative. Each party shall
notify the other in writing as promptly as practicable of any such material
alleged negligent or wrongful acts or omissions on the part of the
Representatives of which it becomes aware along with a plan to remedy such acts
or omissions, and Company shall provide Vendor with a reasonable opportunity to
remedy such acts or omissions, and if indicated, to replace the involved
Representatives.
2.6 Performance Appraisal. From time to time at Company's request
and in any case at 3 months and 6 months after the Product Launch Date, and
every six (6) months thereafter, Vendor and Company shall jointly conduct a
performance appraisal of each Representative. Without limiting its rights under
this Agreement, including Section 2.3(b) and Section 2.5, Company shall have the
right to request the reassignment of any Representative who is achieving less
than 80% of the sales targets established for that Representative for a given
quarter. From time to time at Company's request, Vendor shall make available to
Company for review the primary call data and records.
2.7 Vacancies/Turnover. In the event of a Representative vacancy
due to resignation, reassignment, termination or hiring by the Company pursuant
to Section 3.3 of a Representative, Vendor shall, at Company's request, use its
best efforts to fill any such vacancy within a four (4) week period. All
recruiting and other related expenses for filling a vacancy shall be borne by
Vendor; provided, however, that Company shall reimburse Vendor all recruiting
and other related expenses for filling any vacancy occurring pursuant to
Company's request for reassignment or termination other than: (i) a request
pursuant to the last sentence of Section 2.5, the penultimate sentence of
Section 2.6, or Section 14.7; (ii) due to the Representative's failure
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to conform (or to continue to conform) to the Representatives Profile set forth
in Schedule 2.1; or (iii) due to the failure of the Representative to Detail in
conformity with applicable law or regulations, or to follow Vendor's policies
and procedures. If Company desires to interview any candidates, Company shall
bear its own cost of attending any final interview conducted by Vendor or the
costs of any separate interview arranged for by Company.
2.8 Adjustments to Number of Representatives. No more than every
six (6) months, Company may initiate a review by the parties of the adequacy or
appropriateness of the number of Representatives, and may designate plans, to be
instituted over a period of no longer than ninety (90) days, for an increase or
decrease in the number of Representatives based on the market performance of the
Product, the Detailing of the Product by Representatives who may be hired by
Company as contemplated in Section 3.3 or other parties, or other factors,
provided that Vendor may, upon thirty (30) days prior written notice, terminate
this Agreement in the event that the total number of Representatives under this
Agreement reaches ()twenty (20) Representatives, with no vacancies authorized to
be filled by Company.
2.9 Territory Design. At the request of Company, Vendor shall
design and implement (or redesign and re-implement) a Territory design
(including sizing, deployment, alignment and mapping) of Representatives which
Vendor recommends as optimal for the Detailing of the Products (for the fee set
forth in Schedule 3.1. D, attached hereto).
ARTICLE III
COMPENSATION
3.1. Amount and Time of Payment.
(a) For services hereunder, Company shall pay to Vendor
the fees set forth in Schedule 3.1 attached hereto and incorporated by reference
(the "Services Fee"), which shall be payable as follows:
Time Period - Contract Year Payment Amount
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1st Contract Year A total of $2,000,000.00,
payable in twelve equal
monthly installments of
$166,666.66.
2nd Contract Year Service Fees, plus the
Deferred Fees (as hereinafter
defined).
3rd Contract Year Service Fees, plus the
Deferred Fees (as hereinafter
defined).
At the conclusion of the first Contract Year, Vendor and
Company shall calculate the actual Service Fee for that first contract year. The
"Deferred Fees" shall be the amount of the first year Service Fee plus any other
amount due under this Agreement less the $2,000,000.00 payment
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(i) The Deferred Fees shall be repaid by Company
over the second (2nd) and third (3rd) Contract Years, provided Company is not in
breach of this Agreement and the Agreement remains in full force and effect.
Company shall pay the Deferred Fees in equal monthly installments of principal
plus accrued Interest, beginning on the first day of the thirteenth (13th) month
of the Agreement and continuing on the first (1st) day of each calendar month
thereafter until all outstanding principal and accrued interest has been paid in
full, which in no event shall exceed the first day of the thirty-sixth (36th)
month of this Agreement.
(ii) The Deferred Fees shall accrue interest
beginning the first day of Contract Year two (2) at the rate of the 3-month
LIBOR plus 175 basis points, adjusted quarterly ("Interest").
(b) Vendor shall submit monthly invoices to Company for
all Service Fees and any other amounts due under this Agreement and Company
shall pay such amounts within thirty (30) days of the invoice date.
(c) Notwithstanding any other right or remedy, in the
event of Company's default or a breach of this Agreement and failure of Company
to cure same within fifteen (15) days of notice to such effect by Vendor, all
unpaid principal and accrued but unpaid interest shall be accelerated and
immediately due and payable by Company.
(d) Without limiting Vendor's rights under law or equity,
Vendor and its Affiliates, parent or related entities, may exercise a right of
set off against Company for any and all amounts due under this Agreement
including, but not limited to, the Deferred Fees, against any amounts owed to
Company by Vendor, or its Affiliates, parent, or related entity, if , during the
term of this Agreement, Company defaults on any of its loan covenants with its
third party lenders, or their assignees, which default remains uncorrected for a
period of ten (10) days beyond any applicable cure period.
(e) If this Agreement is terminated prior to expiration
of the Initial Term, all Deferred Fees shall become immediately due and payable
by Company.
(f) In the event the duration of this Agreement is
extended for the Renewal Term, as defined in Section 14.1, Company shall pay
Vendor a Service Fee for the Renewal Term as further negotiated by the parties.
3.2. Early Termination Fee. If during the first 12 months following
the Effective Date, Vendor terminates this Agreement pursuant to Sections 2.8,
14.2, 14.3, 14.6 or 14.7, or Company terminates this Agreement pursuant to
Sections 14.4 or 14.7, Company shall pay Vendor, as reimbursement for Vendor's
expenses in preparing to perform and performing this Agreement, as well as for
Vendor's expectancy interest under this Agreement, a fee equal to the amount set
forth on Schedule 3.2 attached hereto (the "Early Termination Fee"). Company and
Vendor acknowledge that Vendor's damages upon termination of this Agreement
would be difficult to ascertain and not susceptible of ready proof, and that the
Early Termination Fee is
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agreed to as a reasonable estimation of Vendor's damages upon early termination
of the Agreement, and not as a penalty.
3.3. Company's Hiring of Representatives or Managers.
(a) Company acknowledges that Vendor has incurred or will
incur costs and expenses in connection with recruiting, hiring, and training the
Representatives and Managers. During the term of this Agreement, in the event
Company hires as its own employee or as an independent contractor or agent any
one or more of the Representatives, Company shall pay Vendor the fee(s) set
forth in the attached Schedule 3.3. The provisions of this Section 3.3(a) shall
not apply to any Representatives hired by Vendor who were employees of Company
as of the date of this Agreement.
(b) Beginning twelve (12) months following the Effective
Date for Representatives and beginning six (6) months following the Effective
Date for Managers, Company shall have the right to identify those
Representatives or Managers, that Company desires to hire (collectively, the
"Targeted Employees") and to negotiate with any Targeted Employee concerning the
terms on which Company might hire that Targeted Employee. Vendor agrees not to
interfere with the Company's solicitation and hiring of the Targeted Employees ,
and Vendor will assist Company in the transition of Targeted Employees from
Vendor to Company, provided, however, that in the event such Targeted Employer
declines employment with Company, then Vendor shall have the right to discuss
other employment opportunities with such Targeted Employer that would commence
after expiration of the Term of the Agreement and any renewal. For a period of
twelve months after any termination of this Agreement, Vendor agrees not to
solicit for hire as an employee, agent or independent contractor any Targeted
Employee hired by Company during the term of this Agreement.
3.4. Reimbursement of Expenses. Except as provided in Section
3.1(a), all expenses of Vendor for which Company is obligated to reimburse
Vendor under this Agreement, including but not limited to travel expenses and
vehicle expenses under Section 2.2(i), shall be paid by Company within 30 days
after Vendor has submitted a statement itemizing such expenses. Vendor shall use
its best efforts to submit such expense statements to Company monthly.
3.5 Past Due Amounts. Failure of the Company to timely make any
payment to Vendor under this Agreement within fifteen (15) days of the due date
will constitute a material breach of this Agreement by Company. All amounts
owing by Company to Vendor pursuant to this Agreement that are not timely paid
by Company will bear interest at the rate of 10% per annum from the due date.
3.6 Bonus Potential.
(a) Upon execution of this Agreement and no later than
each anniversary of the Effective Date, Company and Vendor shall use good faith
efforts to jointly determine or revise, as the case may be, unit sales forecast
(the "Unit Sales Forecast") for each year following the Product Launch Date
during the Initial Term and any Renewal Term (each such year, a "Detailing
Year") for the purpose of evaluating the Representatives and determining
eligibility
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for a potential Bonus. The Bonus for a given Detailing Year will be based upon
Actual Unit Sales over the Forecasted Unit Sales, as further set forth on
Schedule 3.6 attached hereto, as the same may be amended by the written
agreement of the parties from time to time.
(b) Company shall reimburse Vendor for the Bonus for any
Representative actually paid by Vendor to the Representative in accordance with
Schedule 3.6 no later than sixty (60) days following the close of a Detailing
Year relating to which such Bonus was paid.
ARTICLE IV
REPRESENTATIONS, WARRANTIES AND COVENANTS
4.1. By Vendor. Vendor represents, warrants, and covenants to
Company, as of execution of this Agreement and during the term of this
Agreement, as follows:
(a) that Vendor and the Representatives shall perform the
Detailing in a professional, timely, competent and efficient manner;
(b) that Vendor shall comply with all laws, rules and
regulations that apply to the performance of services under this Agreement,
including but not limited to the PDMA, the Medicare and Medicaid Anti-Kickback
Act (42 U.S.C. Section 1320a-7b(a)), the Civil False Claims Act (31 U.S.C.
Section 3729(a)), Sections 1128A, 1128B, and 1877 of the Social Security Act (42
U.S.C. Sections 1320a-7a, -7b, and 1395nn), the Health Care Fraud Act (18 U.S.C.
Section 1347), and the Criminal False Claims Act (18 U.S.C. Section 287), as
amended from time to time, as well as similar applicable state laws;
(c) when on Company's premises or on the premises of
Company's customers, Vendor and the Representatives shall comply with all of
Company's or Company's customer's policies regarding the conduct of visitors of
which Vendor and the Representatives are aware, a copy of which Vendor
acknowledges receiving;
(d) that the Representatives and Managers shall be
exclusively assigned to Detailing and supervision of the Detailing of the
Products, and no other activities unrelated to the Program;
(e) that Vendor is under no obligation to any third party
that would prevent the execution of this Agreement or interfere with its
performance under this Agreement;
(f) That Vendor is a corporation duly incorporated,
validly existing and in good standing under the laws of the State of Ohio; and
(g) That Vendor has the full right, power and authority
to execute, deliver and perform this Agreement and that this Agreement has been
duly executed and delivered by Vendor and constitutes its legal, valid and
binding obligation, enforceable in accordance with its terms.
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4.2. By Company. Company represents, warrants, and covenants to
Vendor, as of execution of this Agreement and during the term of this Agreement,
as follows:
(a) that Company is under no obligation to any third
party that would prevent the execution of this Agreement or interfere with its
performance under this Agreement;
(b) that Company shall comply with all laws, rules and
regulations that apply to the Products and their sale, the Program, and this
Agreement, including but not limited to the Act, the PDMA, the Medicare and
Medicaid Anti-Kickback Act (42 U.S.C. Section 1320a-7b(a)), the Civil False
Claims Act (31 U.S.C. Section 3729(a)), Sections 1128A, 1128B, and 1877 of the
Social Security Act (42 U.S.C. Sections 1320a-7a, -7b, and 1395nn), the Health
Care Fraud Act (18 U.S.C. Section 1347), and the Criminal False Claims Act (18
U.S.C. Section 287), as amended from time to time, as well as similar applicable
state laws;
(c) that the Product Labeling and Product Promotional
Materials are accurate, complete, and in compliance with the Act and all rules
and regulations of the FDA;
(d) that, subject to FDA approval, the Products may be
lawfully Detailed and sold;
(e) that Company is a corporation duly incorporated,
validly existing and in good standing under the laws of the State of Delaware;
and
(f) that Company has the full right, power and authority
to execute, deliver and perform this Agreement and that this Agreement has been
duly executed and delivered by Company and constitutes its legal, valid and
binding obligation, enforceable in accordance with its terms.
ARTICLE V
STATUS OF VENDOR AND THE REPRESENTATIVES
5.1. Vendor Independent Contractor. Vendor is being retained and
shall perform hereunder strictly as an independent contractor. Representatives
and Managers of Vendor performing services hereunder shall not be, and shall not
be considered to be, employees of Company for any purpose, and shall at all
times remain employees of Vendor, subject to Section 3.3. Neither party shall
have any responsibility for the hiring, termination, compensation, benefits or
other conditions of employment of the other party's employees, except as
otherwise provided in this Agreement.
5.2. No Company Benefits. While employees of Vendor, the Managers
and Representatives are not eligible to participate in any benefits programs or
sales bonuses offered by Company to its employees, or in any pension plans,
profit sharing plans, insurance plans or any other employee benefit plans
offered from time to time by Company to its employees, provided that the
Representatives shall be eligible to participate in Company sales contests if so
requested by Company and approved by Vendor, and former employees of Company
hired by Vendor shall not be required to forfeit any Company benefits. Vendor
acknowledges and agrees
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that Company does not, and will not, maintain or procure any worker's
compensation or unemployment compensation insurance for or on behalf of the
Managers or Representatives while they are employees of Vendor. Vendor
acknowledges and agrees that it shall be solely responsible for paying all
salaries, wages, benefits and other compensation which its employees (including
Representatives and Managers) may be entitled to receive in connection with the
performance of the services hereunder. Notwithstanding the foregoing, Vendor
agrees that Company shall have the right to approve the initial salary payable
to any Representative hired by Vendor who is an employee of Company as of the
date of this Agreement.
5.3 Sales, Use and Excise Taxes. If any state or local government
or other taxing authority determines that sales, use or excise Taxes ("Taxes")
are applicable to Vendor's services performed hereunder, Vendor shall promptly
accrue and Company shall pay such Taxes on behalf of Vendor to the appropriate
taxing authorities. In addition, Company shall be responsible for the payment of
any applicable Taxes related to Company's supply to Vendor of Product
Promotional Materials and Product Samples.
5.4. No Joint Venture. Nothing contained in this Agreement shall be
construed as creating a joint venture or, except as otherwise provided herein,
as granting to either party the authority to bind or contract any obligations in
the name of or on the account of the other party or to make any guarantees or
warranties on behalf of the other party.
ARTICLE VI
TRAINING
6.1. Training Programs.
(a) Company and Vendor shall conduct a training program
(of approximately five (5) days duration) for the Representatives and Managers
prior to the commencement of the Program (but after Company makes pre-stocking
shipments of Products) (the "Training Program"). The Company shall prepare and
conduct its portion of the Training Program on such medical and technical
information about the Products. Vendor shall prepare and conduct its portion of
the Training Program on sales skills, data gathering, regulatory requirements
and applicable laws, recalls, electronic equipment, and Vendor's policies and
procedures. Except as provided in Schedule 3.1, each party shall be responsible
for its own costs in connection with the preparation and conducting its portion
of the Training Program.
(b) In order to qualify for assignment in a Territory, a
Representative must demonstrate thorough knowledge of the Products by passing
Company approved Product tests at a level of proficiency agreed upon by Company
and Vendor.
6.2. Training Materials. With the advice and assistance of Company,
Vendor shall prepare written training materials for the Training Program and an
up-to-date programmed learning unit for the Products, to be sent to each
Representative for "at home" study a minimum of five (5) days prior to the
commencement of the Training Program. Company shall provide vendor with clinical
and other information about the Products in order to prepare such written
training materials and programmed learning unit.
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6.3. Company Assistance. During the term of this Agreement Company
shall assist Vendor's Representatives and Managers with respect to the Training
Program and additional orientation and ongoing training for the Representatives.
ARTICLE VII
SAMPLES
7.1. Provision of Samples. Company shall provide samples of the
Products to the Representatives at Company's option and at its expense. Company
shall determine the quantity and types of samples to be provided to the
Representatives and the method of distribution of the samples. In the event
Company elects to have Vendor manage the storage and distribution of samples,
Vendor shall pass on to Company the actual invoice costs for storage,
distribution and other related costs and use prudent business sense in costs
incurred. All samples shall be stored and handled by Company and Vendor in
compliance with the PDMA and applicable law.
7.2 Sample Accountability. Vendor shall prepare and provide to
Company for approval a sample accountability program applicable to the samples
provided by Company.
7.3. Return of Samples. Within 30 days following the termination or
expiration of this Agreement or within 30 days from the termination or removal
from the Program of a Representative (unless such Representative has been hired
or retained by Company), Vendor shall cause the Representatives to return to
Company all unused Product samples provided to Vendor or the Representatives by
Company. Company shall pay or reimburse Vendor for all costs and expenses in
connection with the storage and shipment of returned samples.
ARTICLE VIII
TRADEMARKS AND INTELLECTUAL PROPERTY RIGHTS
The Products shall be Detailed by Vendor's Representatives under
trademarks owned by Company or an Affiliate of Company. This Agreement does not
constitute a grant to Vendor of any property right or interest in the Products
or any trademarks which Company or an Affiliate of Company uses with respect to
the Products or to the name or business style of Company. Vendor and the
Representatives shall use the Product Promotional Materials only for the
purposes of this Agreement, and all copyright and other intellectual property
rights in the Product Promotional Materials shall remain with Company.
ARTICLE IX
COMMUNICATIONS; MONITORING THE PROGRAM
9.1. Communications from Third Parties. Subject to Article XI,
Vendor and its Representatives shall use their best efforts to advise Company of
all comments, statements, requests and inquiries of the medical profession or
any other third parties relating to the Products that are not addressed by
either Product Labeling or the Product Promotional Materials, of which Vendor
becomes aware. All responses to such communications to the medical profession or
such other third parties shall be handled solely by Company. Vendor shall
provide reasonable
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assistance to Company to the extent requested by Company, and at Company's cost
and expense, to fully respond to such communications.
9.2. Government Agencies. Subject to Article XI, all communications
with government agencies, including the FDA, concerning the Products shall be
the sole responsibility of Company. Vendor shall assist Company with respect to
such communications with government agencies to the extent requested by Company,
and at Company's cost and expense. Vendor shall use its best efforts to provide
Company with any documents or information reasonably requested by Company for
purposes of responding to any communications with government agencies within 24
hours of Company's request.
9.3. Customer Communications. In addition to Detailing, Vendor
shall assist Company with respect to customer communications (as reasonably
requested by Company and at Company's cost and expense) within the Territory and
shall regularly advise Company of market, economic, regulatory and other
developments of which Vendor may become aware which may affect the sale of the
Products in the Territory.
9.4. Appointment of Coordinators. The parties shall each appoint an
authorized coordinator of the Program ("Coordinators") between whom all
communications required or desired to be given will be sent and between whom
Detailing activities will be coordinated. Within 30 days of signing this
Agreement, each party will notify the other as to the name of its Coordinator.
Each party may replace its Coordinator at any time, upon notice to the other
party.
9.5. Review of Results. The parties shall confer periodically, but
at least once per month via telephone conference and once per calendar quarter
in person, if requested by either party, to review and discuss the actual
results compared to the marketing plans for Detailing of the Products, and share
data, reports and other documents relative to such results. A report similar to
the Form of Management Report set forth in Schedule 9.5 attached hereto, shall
be generated by Vendor and provided to Company. Vendor shall, upon Company's
request, include the participation of Representatives and/or Managers in such
review.
ARTICLE X
INSURANCE
10.1. Vendor Insurance Coverage. Vendor shall maintain insurance
coverage as follows:
(a) Workers' Compensation insurance with statutory limits
of liability and Employer's Liability insurance with a limit of $500,000;
(b) Commercial General Liability insurance, including
completed operations and products liability, with a combined single limit of
$2,500,000;
(c) Automobile liability insurance with a combined single
limit of $1,000,000.
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10.2. Company Insurance Coverage. Company shall maintain Commercial
General Liability insurance with a combined single limit of at least $6,000,000
and Products Liability insurance with a limit of at least $10,000,000.
10.3 Certificates of Insurance.All of the foregoing insurance shall
be maintained with responsible carriers and such terms of coverage shall be
evidenced by certificates of insurance furnished by one party to the other. Such
certificates of insurance shall provide for at least 30 days' written notice to
the other party prior to cancellation or modification of any of the material
terms of such coverage, and include the other party as an additional insured.
ARTICLE XI
ADVERSE REACTION REPORTING AND REGULATORY MATTERS
11.1. Immediate Notification. Vendor and Company agree to notify the
other party as soon as reasonably practicable of any information that each may
obtain or learn concerning any Product or package complaint or any serious
unexpected side effect, injury, toxicity, or sensitivity reaction or any
unexpected incidence of severity thereof associated with the clinical uses,
studies, investigations, tests and marketing of the Products, whether or not
determined to be attributable to the Products. "Serious" and "unexpected," as
used herein, shall have the meanings set forth in 21 CFR 314.80(a).Each party
shall also notify the other in a timely manner of any other adverse experience,
i.e., any unfavorable and unintended change in the structure (signs), function
(symptoms) or chemistry (laboratory data) of the body temporally associated with
the use of the Products, whether or not considered related thereto.
11.2. Threatened Agency Action. Vendor and Company shall each
immediately notify the other party of any information that each may obtain or
learn regarding any threatened or pending action by an Agency which may affect
the Products. Vendor shall, at the request of Company and at the cost and
expense of Company, cooperate with Company in formulating a procedure for taking
appropriate action in response to such information. Unless compelled by law,
Vendor shall not respond to an Agency without the prior written consent of
Company.
11.3. Training. Vendor and Company shall develop appropriate
instructions in the Training Program for Representatives as to handling of
information received or obtained subject to Sections 11.1 and 11.2.
ARTICLE XII
RETURN/RECALL
12.1. Returned Products.
(a) Company shall be responsible for handling all
returned Products, including shipment and compensation or credit for the
returned Products. Any Products inadvertently returned to Vendor shall be
shipped to Company or at its direction, in compliance with Company's returned
goods policy, and Vendor shall advise the customer who made the return that the
Products have been returned to Company. Company shall reimburse Vendor's
shipping and other costs in connection with the handling of such returned
Products within 30
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days of delivery to Company of Vendor's statement for such costs. Upon request
Vendor shall provide Company with documentation relating to such costs.
(b) At Company's request, Vendor shall assist Company in
obtaining and receiving any Products that have been recalled, and any costs
incurred by Vendor with respect to participating in any such recall shall be
reimbursed by Company within 30 days of delivery to Company of Vendor's
statement for such costs.
ARTICLE XIII
CONFIDENTIAL INFORMATION
13.1. Confidential Information. Vendor acknowledges and agrees that
it will have access to, or become acquainted with, Confidential Information of
Company in the course of the performance of services under this Agreement. For
the purposes of this Agreement, "Confidential Information" shall mean any
information of Company or any Affiliate thereof, which gives Company an
advantage over its competitors who do not possess such information and
constitutes valuable trade secrets and/or proprietary data which was revealed to
Vendor as a result of entering into or performing its obligations under this
Agreement, including but not limited to, information which relates to Products,
the Program, Target Customers, designs, methods, discoveries, improvements,
documents, trade secrets, proprietary rights, business affairs, customer
information or employee information. Provided, however, that Confidential
Information shall not include any information that:
(a) Was known to Vendor prior to execution of this
Agreement. without an obligation to keep it confidential;
(b) Was lawfully obtained by Vendor from a third party
without any obligation of confidentiality;
(c) Is, at the time of disclosure, in the public
knowledge;
(d) Becomes part of the public knowledge after disclosure
by publication or otherwise, except by breach of this Agreement;
(e) Is developed by Vendor independently and apart from
this Agreement; or
(f) Is otherwise knowledge possessed by Vendor or its
employees as the result of their industry experience or education.
13.2 Handling of Confidential Information. Except as otherwise
required by law, Vendor shall keep all Confidential Information in confidence
and shall not, at any time during or for a period of five (5) years from the
termination of this Agreement, without Company's prior written consent, disclose
or otherwise make available, directly or indirectly, any Confidential
Information to anyone other than Vendor employees and Representatives who need
to know the same in the performance of the services hereunder. Vendor shall use
the Confidential Information only in connection with the performance of the
services hereunder and for no other
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purpose. Vendor shall inform its employees and Representatives of the trade
secret, proprietary and confidential nature of the Confidential Information.
13.3 Prior Confidentiality Agreements. With respect to all
Confidential Information of Company which has previously been or which may be
disclosed to Vendor under the Confidentiality Agreement dated as of April 15,
2000 between the parties hereto or the letter agreement dated April 28, 2000
between Company and Cardinal Health (including the parties encompassed by said
term by footnote) (together, the "Prior Confidentiality Agreements") or this
Agreement, Company shall have the cumulative benefit of Vendor's confidentiality
covenants under the Prior Confidentiality Agreements and this Agreement, and
neither of the Prior Confidentiality Agreements nor this Agreement shall be
deemed to supersede or control over the other such agreements to the
disadvantage of Company with respect to its Confidential Information.
ARTICLE XIV
TERM AND TERMINATION
14.1. Term. This Agreement shall take effect on the date on which
both parties execute this Agreement (the "Effective Date"), but the Program
shall continue in effect until the date thirty-six (36) months after the Product
Launch Date (the "Initial Term"), unless terminated earlier as set forth herein.
Notwithstanding the foregoing, Company may, at its option upon written notice to
Vendor at least 120 days prior to the expiration of the Initial Term, and with
the written consent of Vendor, extend the Initial Term for one additional year
(the "Renewal Term"). If Company desires to exercise renewal term, parties shall
negotiate in good faith provisions of Section 3.1(b) regarding compensation.
References in this Agreement to the term of this Agreement include both the
Initial Term and the Renewal Term, if applicable.
14.2. Bankruptcy: Insolvency. Either party may terminate this
Agreement upon notice to the other upon the occurrence of: (a) the entry of a
decree or order for relief by a court of proper jurisdiction in an involuntary
case of the other party under the Federal Bankruptcy Code, as now constituted or
hereafter amended, or any other applicable federal or state insolvency or other
similar laws, and the continuance of any such decree or order in effect for a
period of sixty (60) consecutive days; or (b) the filing by the other party of a
petition for relief under the Federal Bankruptcy Code, as now constituted or
hereafter amended, or any other applicable federal or state insolvency or
similar laws.
14.3 Termination For Breach. Either party may terminate this
Agreement upon 30 days prior written notice if the other party breaches a
material provision of this Agreement and fails to cure the breach within 15 days
after written notice from the non-breaching party. Provided, however, that such
cure period shall be five (5) days in the case of material breach under Section
3.5.
14.4 Termination Due To Delay in Product Launch. If the Product
Launch Date does not occur within 120 days after the Effective Date, either
party may terminate this Agreement upon 60 days written notice to the other.
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14.5 Termination Due To Regulatory And Other Problems. If the
Product is not being marketed due to regulatory problems, court or
administrative proceedings, product liability claims, recalls, raw materials
shortages, or similar factors beyond the control of Company, then either party
may terminate this Agreement upon 30 days written notice to the other. If the
Agreement is not terminated pursuant to this Section 14.5, (a) the provisions of
Sections 2.3, 2.4, 2.5, 2.6 and 2.7 shall be of no force or effect until the
Company recommences the marketing of the Product; and (b) Company shall not be
permitted to terminate this Agreement pursuant to Section 14.3 until the Company
recommences the marketing of the Product.
14.6 Termination Due To Assignment or Change in Control. In the
event of a Change of Control (defined herein), the party that has had a Change
In Control (the "Affected Party") shall give Notice to the other party (the
"Non-Affected Party") within 30 days of the occurrence of such Change In
Control. If the Change In Control involves a material and direct competitor of
the Non-Affected Party, the Non-Affected Party may terminate this Agreement by
written notice to the Affected Party within 60 days after receipt of the Notice
of a Change In Control. If the Change In Control does not involve a material and
direct competitor of the Non-Affected Party, this Agreement may not be
terminated by the Non-Affected Party. For purposes of this Section, "Change In
Control" includes a purchase, assignment or transfer of a controlling interest
in the Affected Party or substantially all of its business and assets and any
merger or consolidation involving the Affected Party or any Affiliate of the
Affected Party that requires a vote of the stockholders of the Ultimate Parent
of the Affected Party. "Ultimate Parent" for Vendor is Cardinal Health, Inc. and
the Ultimate Parent for Company is its stockholders.
14.7. Termination Due to Discontinuation of Product. Company may
terminate this Agreement on 30 days' prior written notice if Company elects to
discontinue the promotion, sale or distribution of the Product from the
marketplace. This provision shall not be available if Company simply wants to
change the party or parties or means for Detailing the Product.
14.8 Termination: Phase Out. In the event that this Agreement is
terminated pursuant to Sections 14.2 through 14.7 and at Company's request, the
parties shall discuss in good faith an appropriate phase-out of Vendor's
Detailing activities.
14.9. Termination: Continuing Rights. The termination or expiration
of this Agreement shall not affect Company's obligation to reimburse or pay
Vendor any amount then due and owing under this Agreement. Further, the
termination or expiration of this Agreement shall not affect any rights or
obligations of any party under this Agreement which are intended by the parties
to survive such termination. The Service Fee paid by Company for the month in
which this Agreement is terminated shall be prorated based on the number of days
in that month, and Vendor shall refund any overpayment to Company.
14.10 Termination: Return of Materials. Within 60 days following the
termination or expiration of this Agreement, Vendor shall return to Company all
Confidential Information, Product Promotional Materials, marketing plans, forms,
territory lists, reports and any and all other tangible items provided to Vendor
by Company.
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ARTICLE XV
RECORDKEEPING; AUDIT RIGHTS
15.1. Vendor Record Keeping: Inspection by Company. Vendor shall
keep accurate records in sufficient detail as to: (i) Detailing activities by
Representatives; and (ii) costs and expenses for which Company must reimburse
Vendor under this Agreement. Upon Company's reasonable request made during or
within three (3) year after the term of this Agreement, and at Company's
expense, Vendor shall permit Company's designated employees or agents to have
access during ordinary business hours to records of such matters. Company and
its designated employees or agents shall maintain in confidence all such cost
and expense records of Vendor.
ARTICLE XVI
INDEMNIFICATION
16.1 Definitions. As used in this Article 16 and this Agreement,
"Damages" shall mean all liabilities, damages, assessments, levies, losses,
fines, penalties, costs, and expenses, including, without limitation, reasonable
attorneys', accountants', investigators', and experts' fees and expenses,
sustained or incurred as a result of any claims, suits, liabilities, or actions
of any nature.
16. 2. Indemnification by Vendor. Subject to the extent of any
indemnification from Company pursuant to Section 16.3 hereof, Vendor shall
indemnify and hold Company, its Affiliates, directors, officers, employees and
agents harmless from and against any and all Damages, except to the extent such
damages arise from the negligence or intentional wrongful actions of Company,
arising directly or indirectly from:
(a) Vendor's breach of or failure to comply with any of
its obligations under this Agreement;
(b) any inaccuracy in or breach or failure of any
representation, warranty, or covenant made by Vendor in this Agreement;
(c) any negligent or wrongful act or omission on the part
of Vendor or its employees or agents;
(d) Vendor's violation of or failure to comply with all
applicable laws, including but not limited to the Act, the PDMA, the Medicare
and Medicaid Anti-Kickback Act (42 U.S.C. Section 1320a-7b(a)), the Civil False
Claims Act (31 U.S.C. Section 3729(a)), Sections 1128A, 1128B, and 1877 of the
Social Security Act (42 U.S.C. Sections 1320a-7a, -7b, and 1395nn), the Health
Care Fraud Act (18 U.S.C. Section 1347), and the Criminal False Claims Act (18
U.S.C. Section 287), as amended from time to time, as well as similar applicable
state laws;
(e) Detailing of the Products, except to the extent such
Damages arise from a negligent or wrongful act or omission of Company; or
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(f) any federal or state claim or assessment for
nonpayment or late payment by Vendor of any tax or contribution based on the
status of any Representatives as employees of Vendor.
16.3. Indemnification by Company. Subject to the extent of any
indemnification from Vendor pursuant to Section 16.2 hereof, Company shall
indemnify and hold Vendor and its Affiliates, directors, officers, employees and
agents harmless from and against any and all Damages, except to the extent such
damages arise from the negligence or intentional wrongful actions of Vendor,
arising directly or indirectly from:
(a) Company's breach of or failure to comply with any of
its obligations under this Agreement;
(b) any inaccuracy in or breach or failure of any
representation, warranty, or covenant made by Company in this Agreement;
(c) any negligent or wrongful act or omission on the part
of Company or its employees or agents;
(d) Company's violation of or failure to comply with all
applicable laws, including but not limited to the Act, the PDMA, the Medicare
and Medicaid Anti-Kickback Act (42 U.S.C. Section 1320a-7b(a)), the Civil False
Claims Act (31 U.S.C. Section 3729(a)), Sections 1128A, 1128B, and 1877 of the
Social Security Act (42 U.S.C. Sections 1320a-7a, -7b, and 1395nn), the Health
Care Fraud Act (18 U.S.C. Section 1347), and the Criminal False Claims Act (18
U.S.C. Section 287), as amended from time to time, as well as similar applicable
state laws;
(e) Detailing of the Products, except to the extent such
Damages arise from a negligent or wrongful act or omission of Vendor;
(f) the accuracy or completeness of the Product Labels,
Product Promotional Materials, or the Training Program;
(g) any claims or liabilities for injury to or death of
persons, regardless of when such claim or liability is asserted or incurred,
resulting from or arising out of the manufacture, use, sale of the Products, or
a manufacturing design or defect of the Products, or any failure to warn or
inadequacy of warning regarding the Products;
(h) Company's failure to pay when due or to reimburse
Vendor for any Taxes (as defined in Section 5.3);
(i) any negligent or wrongful acts or omissions on the
part of Company with respect to Vendor's employees or Representatives or those
individuals who have made application to be Representatives of Vendor; or
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(j) any federal or state claim or assessment for
nonpayment or late payment by Company of any tax or contribution based on the
status of any former Representatives as employees or agents of Company.
16.4. Indemnification Procedures. A party that intends to claim
indemnification under this Article 16 "(the "Indemnitee") shall promptly notify
the other party (the "Indemnitor") in writing of any action, claim or liability
in respect of which the Indemnitee or any of its employees or agents are
entitled to indemnification. The Indemnitee shall permit, and shall cause its
employees and agents to permit, the Indemnitor at its discretion, to settle any
such action, claim or liability and agrees to the complete control of such
defense or settlement by the Indemnitor. Provided, however, that such settlement
or defense does not adversely affect the Indemnitee's rights hereunder or impose
any obligations on the Indemnitee in addition to those set forth in this
Agreement. The Indemnitee, its employees, and agents, shall cooperate fully with
the Indemnitor and its legal representatives in the investigation and defense of
any action, claim or liability subject to indemnification. The Indemnitee shall
have the right, but not the obligation, to be represented by counsel of its own
selection and at its own expense in connection with any indemnified claim.
16.5. Limitation on Vendor Liability. It is understood that Vendor
is not an insurer and that the sums payable hereunder to Vendor by Company are
based upon the value of services offered and the scope of liability undertaken,
and such sums are not related to any potential liability of Company. Vendor
makes no warranty, expressed or implied, that the services it furnishes will
avert or prevent occurrences or the consequences therefrom which may result in
loss or damage to Company. In the event of any Damages of which Vendor is
liable, Company agrees that Vendor's liability to indemnify Company shall be
limited to the greater of: (i) Two Million Five Hundred Thousand and 00/100
Dollars ($2,500,000.00) or (ii) the total amount paid by Company to Vendor under
this Agreement. Each party hereby waives any and all rights to subrogation that
any insurer of such party may have against the other party. Except as
hereinabove provided, each party agrees that the other party shall not be liable
for any losses or damages, irrespective of origin, to person or property,
whether directly or indirectly caused by performance or non-performance of
obligations imposed by this Agreement or by the negligent acts or omissions of
the other party , its agents, employees or Representatives.
16.6 No Consequential Damages. Notwithstanding any provision of
this Agreement to the contrary, neither party shall be liable to the other for
any consequential damages (other than liability for personal injury as provided
in this Article 16), including lost profits.
ARTICLE XVII
MISCELLANEOUS
17.1. No Waiver: Cumulative Remedies. No failure or delay on the
part of either party in exercising any right, power or remedy hereunder shall
operate as a waiver thereof; nor shall any single or partial exercise of any
such right, power or remedy preclude any other or further exercise thereof or
the exercise of any other right, power or remedy hereunder. No waiver of any
provision hereof shall be effective unless in writing and signed by the party
giving such waiver.
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The remedies herein provided are cumulative and not exclusive of any remedies
provided by law.
17.2. Captions. Article and Section headings used in this Agreement
are for convenience only and shall not affect the construction of this
Agreement.
17.3. Governing Law. This Agreement shall be construed and the
respective rights of the parties hereto determined according to the substantive
laws of the State of Ohio, exclusive of conflict of laws principles.
17.4. Severability. If any provision of this Agreement or any other
document delivered under this Agreement is prohibited or unenforceable in any
jurisdiction, it shall be ineffective in such jurisdiction only to the extent of
such prohibition or unenforceability, and such prohibition or unenforceability
shall not invalidate the balance of such provision to the extent it is not
prohibited or enforceable nor the remaining provisions hereof, nor render
unenforceable such provision in any other jurisdiction. In the event any
provisions of this Agreement shall be held to be invalid, illegal or
unenforceable, the parties hereto shall use their best efforts to substitute a
valid, legal and enforceable provision which, insofar as practical, implements
the purposes hereof.
17.5. Entire Agreement: Modification. This Agreement contains the
entire and exclusive agreement between the parties in respect of the subject
matter hereof and supersedes and cancels all previous agreements, negotiations,
commitments and writings between the parties hereto in respect of the subject
matter hereof. Except as provided herein, this Agreement may not be changed or
modified in any manner or released, discharged, abandoned or otherwise
terminated unless in writing and signed by the duly authorized officers or
representatives of the parties.
17.6. Notices. Any notice or request required or desired to be given
in connection with this Agreement shall be deemed to have been sufficiently
given if sent by pre-paid registered or certified mail or national express
courier (such as Federal Express or UPS) or facsimile transmission to the
intended recipient at the address set forth below or such other address as may
have been furnished in writing by the intended recipient to the sender, and
carrier documentation evidencing delivery to the receiving party or facsimile
answerback is obtained. The date of mailing or facsimile transmission of a valid
notice as described above shall be deemed to be the effective date on which
notice was given.
All notices shall be addressed to:
If to Company, to:
Guilford Pharmaceuticals, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx XX 00000
Fax: 000-000-0000
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Attention:
General Counsel and
Chief Financial Officer
to Vendor, to:
Cardinal Health Sales and Marketing Services,
a division of XxxXxx, Inc.
0000 Xxxxxxxx Xxxxx
Xxxxxx, Xxxx 00000
Fax: (000) 000-0000
Attention:
President
17.7. Execution in Counterparts. This Agreement may be executed in
counterparts, each of which, when executed and delivered, shall be deemed to be
an original and all of which together shall constitute one and the same
document.
17.8. Assignment. This Agreement may not be assigned or transferred
by a party without the prior written consent of the other party hereto.
17.9. Public Announcements. Any public announcement, press release
or similar publicity with respect to this Agreement or the transaction
contemplated hereby shall be at such time and in such manner as the parties
shall mutually agree, provided that nothing herein shall prevent either party
from making such public announcements as it deems necessary in order to comply
with applicable laws and regulations, including disclosure requirements of
federal securities laws and requirements of federal food and drug laws.
17.10. Maintenance of Records. Vendor and Company each agree that
throughout the term of this Agreement and for a period of six years after the
termination of this Agreement, each will maintain records and otherwise
establish procedures to assure compliance with all regulatory, professional, and
other applicable legal requirements which relate to the Detailing and marketing
of the Products and if applicable, with the other services and activities to be
performed hereunder.
17.11. Force Majeure. Failure of either party hereto to fulfill or
perform its obligations under this Agreement shall not subject such party to any
liability if such failure is caused or occasioned by, without limitation, acts
of God, acts of the public enemy, fire, explosion, flood, drought, war, riot,
sabotage, embargo, strikes or other labor disputes (which strikes or disputes
need not be settled), compliance with any order, regulation, or request of
government, or by any other event or circumstance of like or different character
to the foregoing beyond the reasonable control and without the fault or
negligence of such party (a "Force Majeure Event") provided such party uses
reasonable efforts to remove such Force Majeure Event and gives the other party
prompt notice of the existence of such Force Majeure Event. Provided, further,
that
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no Force Majeure Event shall serve to delay or excuse any payment by one party
to the other then due and owing.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized officers.
CARDINAL HEALTH SALES GUILFORD PHARMACEUTICALS INC.
AND MARKETING SERVICES,
a division of XxxXxx, Inc.
By /s/ Xxx Xxxxxxxxxx By /s/ Xxxx X. Xxxxxxx
-------------------------- ----------------------------
Name: Xxx Xxxxxxxxxx Name: Xxxx X. Xxxxxxx
---------------------- ------------------------
Title: President Title: Sr. Vice President
---------------------- ------------------------
Date: October 24, 2000 Date: October 25, 2000
---------------------- ------------------------
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