EXHIBIT 10.8
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT WAS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH RULE
24b-2, PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
OMITTED INFORMATION WAS REPLACED WITH ASTERISKS.
CO-PROMOTION AGREEMENT
THIS CO-PROMOTION AGREEMENT ("Agreement") is entered into as of July 14, 2004
("Effective Date") by and between Cardinal Health PTS, LLC, with an office at
0000 Xxxxxxxx Xxxxx, Xxxxxx, Xxxx 00000 and Bone Care International, Inc.,
having a principal place of business at Bone Care Center, 0000 Xxxxx Xxxxxxx,
Xxxxxxxxx, Xxxxxxxxx 00000 ("BCI") hereinafter collectively referred to as the
"Parties".
RECITALS
WHEREAS, Cardinal Health's Pharmaceutical Technologies and Services
("PTS") segment offers, among other things, health care marketing services,
including without limitation, medical education, marketing, and contract sales
services; and
WHEREAS, BCI owns a pharmaceutical product called Hectorol(R) which is
currently available in 0.5 mcg capsule and 2.5 mcg capsule dosage forms for the
following indications, respectively: secondary hyperparathyroidism in Stage 3-4
Chronic Kidney Disease; and secondary hyperthyroidism in Stage 5 Chronic Kidney
Disease (CKD); and
WHEREAS, BCI has recently received approval of the 0.5 mcg dosage form;
and
WHEREAS, BCI wants to generate increased demand for Hectorol(R) 0.5 mcg
capsules through increased medical education, Product Detailing, and other
marketing of the 0.5 mcg Product; and
WHEREAS, Cardinal Health's PTS segment will provide a certain level of
healthcare marketing services, including a contract sales force and promotional
services, at its own expense in exchange for a share of Quarterly Net Sales
(defined below) of the 0.5 mcg Product, subject to the terms and conditions
provided in this Agreement; and
WHEREAS, BCI will commit to a certain level of spending on promotion, at
its own expense, in order to supporting the marketing of the 0.5 mcg Product and
to induce Cardinal Health to enter into this Agreement, subject to the terms and
conditions provided herein.
NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions
set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Definitions. The following terms when used in this Agreement and the
attached schedules 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" means any corporate or non-corporate business entity
that controls, is controlled by, or is under common control with a party to this
Agreement. A corporation or non-corporate business entity shall be regarded as
in control of another corporation if it owns or directly or indirectly controls
at least forty percent (40%) of the voting stock of the other corporation, or
(i) in the absence of the ownership of at least forty percent (40%) of the
voting stock of a corporation or (ii) in the case of a non-corporate business
entity, if it possesses directly or indirectly, the power to direct or cause the
direction of the management and policies of such corporation or non-corporate
business entity, as applicable.
(c) "Applicable Laws" means all federal, state and local laws, rules,
regulations, guidances, ordinances applicable to the obligations of a party
under this Agreement.
(d) "Cardinal Promotional Spend" means collectively the total amount
spent by Cardinal Health in connection with promotion of the Product as set
forth on Schedule 3.1 and Schedule 5.1, as such amounts are amended from time to
time upon the mutual written agreement of the Parties or as otherwise set forth
in this Agreement.
(e) "Confidential Information" shall have the meaning set forth in
Section 9.2.
(f) "Contract Sales Services" means those services provided by Cardinal
Health pursuant to Article 5 of this Agreement.
(g) "Coordinators" shall have the meaning set forth in Section 13 of
Schedule 5.3.
(h) "Co-Promote Fee" has the meaning set forth in Section 6.1.
(i) "Damages" shall have the meaning set forth in Section 12.1.
(j) "Direct Expenses" shall have the meaning set forth in Section
4.5(a).
(k) "FDA" means the United States Food and Drug Administration and any
successor agency having substantially the same functions.
(l) "Detail" means a legally compliant, interactive, and face-to-face
visit by a Representative with a Target Physician during which the FDA-approved
indicated uses, safety, effectiveness, contraindications, side effects, warnings
and other relevant characteristics of the Products are described by the
Representative in a fair and balanced manner consistent with the
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requirements of the Act, and using, as necessary or desirable, the Product
Labeling and the Product Promotional Materials. "Product Detail" means Detail of
a Product between Target Physician and Representative. When used as a verb,
"Detail" or "Detailing" shall mean to engage in a Detail as defined in this
definition.
(m) "Employee Selection Period" shall have the meaning set forth in
Section 5.7(d).
(n) "Fiscal Quarter" means each successive three month period beginning
on July 1 of each fiscal year, such that (i) Q1 of a year represents July
through September, Q2 represents October through December, Q3 represents January
through March, and Q4 represents April through June, and (ii) fiscal year 2004
begins on July 1 of 2003, fiscal year 2005 begins on July of 2004 and so on.
(o) "Force Majeure Event" shall have the meaning set forth in Section
15.11.
(p) "Forecasted Quarterly Net Sales" shall be the forecasted Quarterly
Net Sales for a particular Fiscal Quarter, as set forth on Schedule 6.1.
(q) "JCC" has the meaning set forth in Section 2.1 of this Agreement.
(r) "Indemnitee" shall have the meaning set forth in Section 12.4.
(s) "Indemnitor" shall have the meaning set forth in Section 12.4.
(t) "Manager" means any individuals hired by and retained by Cardinal
Health as an employee in a managerial position over the Representatives.
(u) "Medical Education Services" shall mean the services to be provided
by Cardinal Health pursuant to Article 4 of this Agreement.
(v) "Medical Education Standards" shall have the meaning set forth in
Section 4.3.
(w) "Net Cost" shall mean the gross amount charged by a supplier, less
all available discounts and allowances recognized by Cardinal Health, and less
any Cardinal Health discount directly attributable to BCI.
(x) "OIG" means the Office of the Inspector General of the Department of
Health and Human Services.
(y) "Other Expenses" shall have the meaning set forth in Section 4.5(b).
(z) "PDMA" means the Prescription Drug Marketing Act of 1987, as
amended, and the regulations promulgated thereunder from time to time.
(aa) "Product" shall mean BCI's Hectorol(R) product in the 0.5 mcg dosage
form.
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(bb) "Product Labeling" means all labels and other written, printed, or
graphic matter provided by BCI including (i) any container or wrapper utilized
with a Product, or (ii) any written material accompanying a Product, including,
without limitation, Product package inserts.
(cc) "Product Promotional Materials" means all written, printed or
graphic material provided by BCI, 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 BCI deems necessary or appropriate to conduct the
Contract Sales Services. Product Promotional Materials shall include FDA
approved indicated uses, safety, effectiveness, contraindications, side effects,
warnings and other relevant characteristics of each of the Products.
(dd) "Quarterly Net Sales" means the gross sales of Product as recorded
by BCI, its Affiliates or its sublicensees in accordance with Generally Accepted
Accounting Principles ("GAAP") in a particular Fiscal Quarter, less reasonable
and customary deductions for (i) ordinary and customary trade discounts in
connection with third party sales, (ii) sales and excise taxes, customs duties
and compulsory payments to governmental authorities actually paid or deducted in
connection with such sales, and (iii) credits given to customers for rejects and
returns of the Product.
(ee) "Regulatory Authority" means any governmental regulatory authority
responsible for granting approvals for the sale or maintaining regulatory
oversight of the Products or the marketing, reimbursement, or other issues
affecting the Products, including, without limitation, the FDA.
(ff) "Representative" and "Representatives" mean an individual hired by
and retained as an employee of Cardinal Health to conduct Detailing of Products
in connection with the Contract Sales Services. As sometimes used in this
Agreement, "Representatives" shall also include "Managers."
(gg) "Specialty Pharmaceutical Services" means services rendered by
Cardinal Health pursuant to the Distribution Services Agreement between Cardinal
Health PTS, LLC (successor by merger to CORD Logistics, Inc.) and BCI dated Oct.
5, 1999, as amended.
(hh) "Target" or "Target Physician" means a physician or other specialist
identified by BCI.
(ii) "Targeted Employees" shall have the meaning set forth in Section
5.7(d).
(jj) "Taxes" shall have the meaning set forth in Section 6.6.
(kk) "Term" shall have the meaning set forth in Section 14.1.
(ll) "Termination Fee" shall have the meaning set forth in Section
14.4(b).
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(mm) "Training Program" shall have the meaning set forth in Schedule 5.3,
Section 9(a).
ARTICLE 2
PROJECT MANAGEMENT
2.1 Joint Commercialization Committee.
(a) Within thirty (30) days of the Effective Date of this Agreement, the
Parties shall form a committee to assist in overseeing and implementing the
sales, marketing and co-promotion of the Products in accordance with the terms
and conditions of this Agreement ("JCC"). The JCC shall consist of an equal
number of representatives from each Party and each party will have an equal
number of votes with respect to any decisions made by the JCC.
(b) The JCC shall meet at least once monthly to (i) develop, approve and
amend (as necessary) a marketing plan for the Product for each year of this
Agreement ("Yearly Marketing Plan"), (ii) review the status of all sales,
marketing and co-promotion efforts relating to the Product, (iii) review and
approve strategies, budgets and allocation of all promotional efforts to be
funded out of the commitments made by each Party pursuant to Article 3 of this
Agreement, and (iv) make any other decisions required of the JCC under this
Agreement. JCC meetings shall be held at mutually agreed upon dates, times, and
places, or by conference call if all members of the JCC agree.
(c) The JCC shall have the authority to request an increase in the
promotional spend incurred by each party under Article 3. Any such increase
shall only be effective upon the mutual written agreement of both Parties. The
JCC will have the authority to decrease the Cardinal Promotional Spend and BCI
Promotional Spend as mutually agreed upon by the JCC after the first six months
of this Agreement, if the Quarterly Net Sales for any Fiscal Quarter are ten
percent or more less than the forecast of Quarterly Net Sales for that quarter,
as set forth on Schedule 6.1. If the JCC cannot agree upon such decrease, the
Cardinal Promotional Spend and the BCI Promotional Spend shall automatically
decrease in accordance with the schedule set forth on Schedule 2.1(c) of this
Agreement.
(d) In the event the JCC is unable to reach agreement with respect to
any material issue related to its obligations under this Article 2, either party
may present the issue to the President of BCI and the President of the
Healthcare Marketing Services group of Cardinal Health, who shall negotiate in
good faith to resolve such dispute. Except as provided in 2.1(c), in the event
they are unable to resolve the dispute within thirty (30) days of receipt of
substantive written information and materials relating to the dispute, the final
decision will be made by the President of BCI. Disagreements which are purely
legal in nature will be handled in accordance with Section 15.13 of this
Agreement.
2.2 Business Managers. Each party will provide a business manager to oversee
activities under this Agreement and to act as a primary contact for day to day
activities under the Agreement.
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ARTICLE 3
PROMOTIONAL SPEND
3.1 Cardinal Health. Cardinal Health shall provide (i) Medical Education
Services and Specialty Pharmaceutical Services in connection with the Product
and in that regard, shall spend at least the amounts set forth on Schedule 3.1
during the Term of the Agreement with respect to such services ("Cardinal
Flexible Promotional Spend"), and (ii) Contract Sales Services in accordance
with Article 5 and Schedule 5.1. Appropriation of the Cardinal Flexible
Promotional Spend toward any particular activity shall be approved by the JCC
substantially in accordance with Schedule 3.1 unless otherwise agreed to by the
Parties in writing.
3.2 BCI. BCI or its designated agent or subcontractor shall provide a
promotional investment in connection with the Product and in that regard, shall
spend the amounts set forth on Schedule 3.2 during the Term of the Agreement
("BCI Promotional Spend"). The BCI Promotional Spend shall be approved by the
JCC substantially in accordance with Schedule 3.2 unless otherwise agreed to by
the Parties in writing. The Parties agree that amounts paid to Cardinal Health
under the Distribution Services Agreement between Cardinal Health PTS, LLC
(successor by merger to CORD Logistics, Inc.) and BCI dated Oct. 5, 1999, as
amended, for sampling of the 0.5 mcg Product may count towards satisfaction of
the BCI Promotional Spend as agreed upon by the JCC.
ARTICLE 4
MEDICAL EDUCATION SERVICES
4.1 Proposals. Cardinal Health shall perform such medical education and
promotional services as are approved by the JCC and mutually agreed upon by the
Parties (the "Medical Education Services"). All such services shall be
specifically set forth in a written document approved by the JCC, signed by the
Parties, and shall be performed in accordance with this Agreement.
4.2 Previously Approved Indications. This Agreement does not cover services
provided by Cardinal Health with respect to the 2.5 mcg Product or products for
indications approved by the FDA prior to April 1, 2004.
4.3 BCI Review and Approval of Medical Education Services. BCI shall be solely
responsible for preparing and reviewing the content of all materials prepared
for and intended for use in provision of Medical Education Services and related
materials prior to the performance of such Medical Education Services. BCI shall
ensure that all materials prepared for and intended for use in Medical Education
Services and any and all related materials comply with all Applicable Laws and
all applicable industry standards and practices generally applicable to the
pharmaceutical industry, including, without limitation, the research guidelines,
ethics and standards established by the American Medical Association, the FDA,
the standards and guidelines outlined in the PhRMA Code, and the standards and
guidelines outlined in the OIG Guidance (collectively, "Medical Education
Standards"). BCI hereby acknowledges that Cardinal Health will not conduct a
legal review of the materials prepared for and intended for use
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in the Medical Education Services and/or related materials and that Cardinal
Health is relying solely on BCI to make certain that such materials comply with
all Applicable Laws and Medical Education Standards. BCI personnel who manage
Medical Education Services shall be solely responsible for insuring that BCI's
counsel have an opportunity to review all legal issues and matters as BCI may
deem appropriate related to the Medical Education Services, and shall, upon
request, inform Cardinal Health of the results of same review either orally or
in writing. Notwithstanding the foregoing, Cardinal Health shall be solely
responsible for ensuring that the Medical Education Services are performed in a
manner consistent with Medical Education Standards and that it shall not deviate
from the scope and content of the Materials prepared by BCI and intended for use
in the performance of the Medical Education Services.
4.4 Additional Medical Education Services. The Parties contemplate that
Cardinal Health may perform additional Medical Education Services for BCI
relating to the Product that are not part of the Cardinal Promotional Spend. In
such cases, the Parties shall agree in writing on the scope of work to be
performed, additional or modified terms, and discounted payment for such work.
Nothing in this Section 4.4 or in Article 4 or the remainder of this Agreement
obliges either Party to enter into negotiations with respect to such an
additional agreement, nor do the parties contemplate that such an additional
agreement shall have any effect on the other rights or obligations of the
parties under this Agreement.
4.5 Pricing and Payment Terms. In the event that BCI engages Cardinal Health
to provide Medical Education Services that are not included in the Cardinal
Promotional Spend, the discounted pricing and payment terms for such Medical
Education Services shall be as set forth in proposals mutually agreed to by the
Parties in writing and shall include the following, unless otherwise agreed to
by BCI and Cardinal Health:
(a) Direct Expenses. The Direct Expenses set forth in any proposal for
Medical Education Services represent a good faith estimate of Direct Expenses to
be incurred by Cardinal Health in the performance of Medical Education Services.
Notwithstanding the foregoing, BCI shall reimburse Cardinal Health for all
reasonable out-of-pocket expenses (the "Direct Expenses") actually incurred by
Cardinal Health in the performance of the Medical Education Services whether or
not such Direct Expenses actually exceed the amount estimated in good faith in
any proposal. Direct Expense items shall include, but not be limited to, the
following:
(1) Travel (including mileage at the IRS approved rate of 36.5
cents per mile, if travel is by car), living expenses when authorized by BCI,
and long-distance telephone charges incurred in the conduct of BCI's business;
(2) Net Cost of postage, express, courier, overnight and freight
on all shipments of materials, including, but not limited to proofs, artwork,
videotapes, slides, props, transcriptions, computer disks, etc., as appropriate
to the timeline and delivery schedule agreed to by the Parties;
(3) Net Cost of unusual charges incurred at the special request of
BCI or if necessary to the rendering of special or abnormal service, or to meet
emergencies, or departure from the regular routine of business. These charges
must be specified in writing (may be
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handwritten at the scene) and signed off by BCI at the correct signing level or
thereby delegated to by their supervisor; and
(4) Reimbursement for the Net Cost of freelance labor use.
BCI shall not be required to reimburse Cardinal Health for (i) facsimile,
telephone and postage charges incurred in the normal conduct of business; and
(ii) unapproved Cardinal Health-initiated travel.
(b) Other Expenses. In addition to those items set forth in a proposal
for Medical Education Services or any other proposal, BCI shall also reimburse
Cardinal Health for certain costs for enduring materials and related services,
including but not limited to research authorized by BCI and incurred through the
efforts of Cardinal Health on behalf of BCI (the "Other Expenses").
(c) Discounts. Cardinal Health shall use commercially reasonable efforts
to obtain all prompt payment, volume, frequency or other similar discounts from
media and suppliers from which it makes purchases of Direct Expenses in the
performance of the Medical Education Services hereunder.
(d) Vendor/Cardinal Health Affiliation. In the event that any Medical
Education Services are to be performed or materials purchased from a supplier in
which Cardinal Health or Cardinal Health personnel have any financial interest,
disclosure of the relationship shall be made to BCI and Cardinal Health shall
obtain BCI's prior approval of the engagement of or purchase from such supplier.
(e) Advance Payment for Certain Expenses. In accordance with the
principle that Cardinal Health is not expected to finance Direct Expenses and
Other Expenses, BCI will be billed and invoices will be paid so that Cardinal
Health will have such funds in hand before payment is due to all third party
suppliers, including, but not limited to airlines, hotels, suppliers of goods
and services purchased on behalf of BCI, at BCI's request, honoraria, and any
other substantial (more than $1,000) expenses. All invoices for Direct Expenses
and Other Expenses are payable to Cardinal Health within (30) days after receipt
by BCI unless otherwise mutually agreed.
4.6 Audits. A certified public accounting firm of BCI's choice and acceptable
to Cardinal Health may conduct an annual audit of Cardinal Health's books,
records and accounts pertaining only to the Medical Education Services
undertaken for BCI pursuant to this Agreement and shall certify that such
records are kept in accordance with generally accepted industry standards
consistently applied and that the allocation of fees hours to BCI or the
Cardinal Promotional Spend are accurate and as provided in this Agreement and
the proposal agreed upon by the Parties.
ARTICLE 5
CONTRACT SALES SERVICES
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5.1 Furnishing Representatives. Cardinal Health shall recruit and hire
Representatives in such numbers as are set forth on Schedule 5.1 of this
Agreement to engage in Product Detail activities to Target Physicians in
accordance with the terms of this Agreement and the attached Schedules. In the
event that BCI engages Cardinal Health to provide Contract Sales Services at
levels greater than those specified on Schedule 5.1, the discounted pricing and
payment terms for such additional Contract Sales Services ("Additional CSO
Services") shall be as set forth in proposals mutually agreed to by the Parties
in writing which incorporate this Agreement by reference.
5.2 Assignment of Representatives. Cardinal Health shall assign
Representatives for the Target Physicians in such numbers and in such
territories as shall be agreed upon by the JCC. Each Representative shall make
Product Details on his or her assigned Target Physicians based on the general
direction given by the JCC. 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
for the Products. All Product Details shall be undertaken consistent with the
Medical Education Standards.
5.3 Scope of Activities. Each of the Parties shall have the specific duties
set forth in Schedule 5.3, as applicable, in connection with the Contract Sales
Services.
5.4 Orders for Products. BCI shall be solely responsible for establishing the
terms and conditions of the sale of the Products to any third party customers,
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. Except as otherwise
expressly provided in this Agreement, BCI or its agent 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 Cardinal
Health or the Representatives receive an order for the Products, they shall
immediately transmit such order to BCI for further handling and communications
with the submitter of the order, including acceptance or rejection, which shall
be in BCI's sole discretion.
5.5 Representatives' Activity. Subject to BCI'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 Cardinal Health pursuant to
this Agreement shall be deemed to be negligent or wrongful acts or omissions of
Cardinal Health; provided, however, that any acts or omissions of the
Representatives pursuant to the specific direction, control or supervision of
BCI or its employees or agents (other than Cardinal Health) shall not be deemed
to be negligent or wrongful acts or omissions of Cardinal Health. 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 BCI shall provide Cardinal Health with a reasonable
opportunity to remedy such acts or omissions, and if indicated, to replace the
involved Representatives.
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5.6 Vacancies/Turnover. In the event of a Representative vacancy due to
resignation, reassignment or termination of a Representative, Cardinal Health
shall use its commercially reasonable best efforts to fill any such vacancy
within an eight (8) week period. Expenses for filling such vacancy shall be
included in the cost of the Contract Sales Services as set forth in Schedule
5.1. In addition, if BCI desires to interview any candidates, BCI shall bear its
own cost of attending any final interview conducted by Cardinal Health or the
costs of any separate interview arranged for by BCI.
5.7 BCI's Termination, Removal, or Hiring of Representatives.
(a) BCI agrees not to hire any Representative, directly or indirectly,
during the first twelve months of the Term of this Agreement unless this
Agreement is terminated in accordance with Section 14.2(b) (due to uncured
breach by Cardinal Health), Section 14.2(e), Section 14.4(b), Section 14.5 or
BCI buys out the Contract Sales Service portion of this Agreement in accordance
with Section 5.7(c). BCI and Cardinal Health acknowledge that Cardinal Health
would suffer damages upon breach of this Section and such damages would be
difficult to ascertain and are not susceptible of ready proof. As a result, the
Parties agree that BCI shall pay Cardinal Health liquidated damages of $250,000
per representative and $350,000 per Manager hired by BCI in violation of this
Section.
(b) If BCI requests termination or removal from the Program of any
Representative and such Representative is in fact so terminated or removed by
Cardinal Health, then BCI shall be responsible for severance and related
expenses for each such Representative so terminated or removed unless (for a
reason other than BCI's negligence, willful misconduct or breach of this
Agreement) such termination or removal is (i) pursuant to the last sentence of
Section 5.5, (ii) due to a failure of the Representative to comply with the
obligations set forth in Schedule 5.3, (iii) due to such Representative's
failure to adequately achieve the performance goals of the Program, or (iv)
failure to comply with all Applicable Laws and any BCI Detailing requirements
which are consistent with labeled indications and the guidelines promulgated by
PhRMA and the OIG.. Cardinal Health shall fill any vacancy created by BCI's
hiring of Representatives or Managers pursuant to this Section as provided in
Section 5.6. BCI agrees that it will not, for a period of eighteen (18) months
following termination or removal of a Representative or Manager in accordance
with this Section, hire, retain or otherwise solicit, directly or indirectly,
any such Representative or Manager.
(c) BCI shall have the right to buy out the Contract Sales Services
portion of this Agreement by hiring the Representatives as its own employees and
paying to Cardinal Health the Contract Sales Services Buyout Fee set forth in
Schedule 5.7(c). BCI shall provide Cardinal Health at least ninety (90) days
notice of a buy out in accordance with this Section. In the event that this
option is exercised and BCI buys out the Contract Sales Services portion of this
Agreement, the applicable Co Promote fee will be reduced in accordance with
Schedule 6.1.
(d) During the six (6) month period immediately prior to the end of the
Term, BCI shall identify all those Representatives BCI desires to hire
(collectively, the "Targeted Employees") after the completion of the Term and to
negotiate with any Targeted Employee
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concerning the terms on which BCI might hire that Targeted Employee. At the end
of the Term, BCI shall have a period of thirty (30) days (the "Employee
Selection Period") to hire some or all of the Targeted Employees. Cardinal
Health agrees not to interfere with BCI's solicitation and hiring of the
Targeted Employees prior to or during the Employee Selection Period, and
Cardinal Health will assist BCI in the transition of Targeted Employees from
Cardinal Health to BCI.
(e) For a period of twelve (12) months after the expiration of the
Employee Selection Period: (i) BCI shall not hire or retain as an employee or as
agent or independent contractor any Representatives that are not Targeted
Employees or are not actually hired by BCI during the Employee Selection Period,
and (iii) BCI agrees that it will not, for a period of twelve months following
the expiration or termination of this Agreement, hire, retain or otherwise
solicit any Manager of Cardinal Health to be an employee either of BCI or any of
its Affiliates. Cardinal Health will not solicit for hire as an employee, agent
or independent contractor any Representative hired by BCI if such hiring is
allowed by this Section 5.7.
5.8 No BCI Benefits. Employees of Cardinal Health and Representatives are not
eligible to participate in any benefits programs or sales bonuses offered by BCI
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 BCI to its
employees, provided that the Representatives shall be eligible to participate in
BCI sales contests if so requested by BCI and approved by Cardinal Health.
Cardinal Health acknowledges and agrees that BCI does not, and will not,
maintain or procure any worker's compensation or unemployment compensation
insurance for or on behalf of the Representatives while they are employees of
Cardinal Health. Cardinal Health acknowledges and agrees that it shall be solely
responsible for paying all salaries, wages, benefits, bonuses, pension plans,
profit sharing plans and other compensation or benefits which its employees
(including Representatives) may be entitled to receive in connection with the
performance of the services hereunder.
ARTICLE 6
FEES
6.1 Co-Promote Fee. In further consideration of Cardinal Health's efforts and
performance hereunder, BCI shall pay Cardinal Health a variable percentage of
all Quarterly Net Sales of the Product during each Fiscal Quarter, as such
percentages are set forth in Schedule 6.1 ("Co-Promote Fee") during the Term of
this Agreement. In the event BCI buys out the Contract Sales Service portion of
this Agreement as provided in Section 5.7(c), BCI shall pay a reduced Co-Promote
Fee as provided in Schedule 6.1.
6.2 Product Supply. BCI shall use reasonable commercial efforts to maintain an
adequate level of inventory to supply orders for Product from third party
customers; provided, however, that BCI shall not be responsible to the extent
any failure to maintain inventory results from a failure of Cardinal Health to
provide services in accordance with the terms of a separate manufacturing,
packaging, analytical, distribution or logistics agreement which are necessary
to release finished Product for commercial sale.
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6.3 Payment. BCI shall pay the Co-Promote Fee to Cardinal Health within
forty-five (45) days following end of each Fiscal Quarter ("Co-Promote
Payment").
6.4 Audit. BCI shall include with each Co-Promote Payment a statement setting
forth in reasonable detail its calculation of the Co-Promote Payment for the
period covered by such Co-Promote Payment along with a reconciliation detailing
the reasons for any differences between the Quarterly Net Sales reported to
Cardinal Health and the revenue reported in BCI's quarterly SEC 10Q filings.
Cardinal Health or its designee shall be entitled, upon reasonable advance
notice to BCI, to audit BCI's books and records relating to the Quarterly Net
Sales for any one or more payments periods under this Agreement. Cardinal Health
and BCI will attempt in good faith to settle any dispute within thirty (30) days
after Cardinal Health's delivery of audit findings to BCI. If such audit reveals
that there is an underpayment of any amounts owed to Cardinal Health, BCI shall
pay such amounts in full within ten (10) days of such determination, and if such
amount is in excess of ten percent (10%) or more of the amount paid by BCI for
any period, BCI shall reimburse Cardinal Health for all reasonable out-of-pocket
costs incurred in performing such audit. Cardinal Health's right to perform an
audit in accordance with this Section shall continue for a period of two years
following termination or expiration of this Agreement for any reason.
6.5 Price Normalization. BCI acknowledges that (i) the current wholesale
acquisition cost (WAC) for the 0.5 mcg Product is $*** per tablet and the
current WAC for the 2.5 mcg product is $*** and (ii) this pricing arrangement
may lead to prescriptions of the 2.5 mcg Product where a higher daily/weekly
dosage is required. As a result, Cardinal Health would not realize the full
value of the Co-Promote Fee for sales of Product under this Agreement.
Notwithstanding the terms of Section 6.1, in order to account for this pricing
arrangement, the Co-Promote fee shall be determined in accordance with (a) the
row entitled "Co Promote Fee % (if price normalization applies)" as set forth in
Schedule 6.1 if the Contract Sales Services portion of this Agreement is still
in effect or (b) the row entitled "Co Promote Fee % after Contract Sales Service
Buy Out (if price normalization applies)" as set forth in Schedule 6.1 if the
Contract Sales Services portion of this Agreement has been bought out, for each
Fiscal Quarter in which the actual volume of capsules of the Hectorol 2.5 mcg
product sold in such Fiscal Quarter exceed by ***% or more the baseline forecast
projected for that Fiscal Quarter as set forth on Schedule 6.1.
6.6 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 any Cardinal Health services provided under this Agreement which
are not paid for by Cardinal Health as part of the Cardinal Promotional Spend,
BCI shall reimburse Cardinal Health for any such Taxes paid by Cardinal Health
to the appropriate taxing authorities.
6.7 Past Due Amounts. BCI's failure to timely make any payment to Cardinal
Health under this Agreement (including without limitation, this Article and
Articles 4 and 5) will constitute a material breach of this Agreement by BCI.
All amounts owing by BCI to Cardinal Health pursuant to this Agreement that are
not timely paid by BCI will bear interest from the due date, at the lower of (i)
one and one-half percent per month, or (ii) the maximum rate permitted by law.
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6.8 Setoff. Without limiting Cardinal Health's rights under law or in equity,
Cardinal Health and its affiliates, parent or related entities, collectively or
individually, may exercise a right of set-off against any and all amounts due to
Cardinal Health from BCI. For purposes of this Section 6.8, Cardinal Health, its
affiliates, parent or related entities shall be deemed to be a single creditor.
ARTICLE 7
REGULATORY MATTERS
7.1 Government Agencies. All communications with Regulatory Authorities,
including the FDA, concerning the Products shall be the sole responsibility of
BCI. Cardinal Health shall assist BCI with respect to such communications with
Regulatory Authorities to the extent requested by BCI. Cardinal Health shall use
its best efforts to provide BCI with any documents or information reasonably
requested by BCI for purposes of responding to any communications with
Regulatory Authorities within 72 hours of BCI's request. Each party shall
promptly notify the other party of any communication it receives from Regulatory
Authorities concerning the Products or any services furnished under this
Agreement.
7.2 Maintenance of Records. Cardinal Health and BCI each agree that throughout
the Term of this Agreement and for a period of six years after the termination
of this Agreement, each party will maintain records and otherwise establish
procedures to assure compliance with all Applicable Laws which relate to the
Detailing and marketing of the Products.
ARTICLE 8
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1 By Cardinal Health. Cardinal Health represents, warrants, and covenants to
BCI that, as of the date of this Agreement and during the Term of this
Agreement:
(a) Cardinal Health and the Representatives shall perform the Detailing
in a professional and timely manner;
(b) Cardinal Health shall comply with all Applicable Laws to the extent
that such laws 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), the Criminal False Claims Act (18 U.S.C. Section 287), and the
Health Insurance Portablility and Accountability Act of 1996, as amended from
time to time, as well as similar applicable state laws; and
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(c) When on BCI's premises or on the premises of BCI's customers,
Cardinal Health and the Representatives shall comply with all of BCI's or BCI's
customer's policies regarding the conduct of visitors of which Cardinal Health
and the Representatives are aware.
8.2 By BCI. BCI represents, warrants, and covenants to Cardinal Health that,
as of the date of this Agreement and during the Term of this Agreement:
(a) All Product supplied to Cardinal Health under this Agreement for use
as samples in Details shall be manufactured and delivered to Cardinal Health in
conformity with the Act, as amended, and all other Applicable Laws and such
Product shall not be adulterated or misbranded with the meaning of the Act;
(b) It shall confirm that all materials prepared by BCI in accordance
with Section 4.3 will comply with all Applicable Laws and Medical Education
Standards prior to authorizing Cardinal Health to perform the Medical Education
Services;
(c) To its knowledge, there are no trade secrets or other proprietary
rights of others related to the Products which would be infringed or misused by
Cardinal Health's performance of this Agreement;
(d) BCI shall comply with all Applicable Laws that apply to the Products
and their sale and BCI's performance of its obligations under 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;
(e) The Product Labeling and Product Promotional Materials are accurate,
complete, and in compliance with the Act and all Applicable Laws; and
(f) The use and sale of the Products in accordance with the terms of
this Agreement do not and will not during the Term of this Agreement, infringe
any patent or other proprietary rights of third Parties, and the Products have
all necessary governmental approvals and may be lawfully Detailed and sold by
BCI and the Representatives.
8.3 Mutual. Each party represents, warrants, and covenants to the other party
that, as of the date of this Agreement and during the Term of this Agreement:
(a) It shall comply with all Applicable Laws applicable to its
operations, including but not limited to, those dealing with employment
opportunity and affirmative action including Executive Order 11246 (Equal
Opportunity), 38 U.S.C. Section 4212(a) (Affirmative Action for Disabled
Veterans and Veterans of the Vietnam Era), and 29 U.S.C. Section 793
(Affirmative Action for Workers with Disabilities), and any amendment and
applicable regulations pertaining thereto;
14
(b) In accordance with the provisions of 48 C.F.R. Section 52.209-6, it
certifies that neither it nor its principals was or is debarred, suspended,
proposed for debarment or otherwise determined to be ineligible to participate
in federal health care programs (as that term is defined in 42 U.S.C.
1320a-7b(f)) or convicted of a criminal offense related to the provision of
health care items or services, but has not yet been debarred, suspended,
proposed for debarment or otherwise determined to be ineligible to participate
in federal health care programs. In the event that either party, or any of its
principals, is debarred, suspended, proposed for debarment or otherwise
determined to be ineligible to participate in federal health care programs or
convicted of a criminal offense related to the provision of health care items or
services, each party shall notify the other party immediately;
(c) It complies with all Applicable Laws, conventions or treaties
prohibiting any form of child labor or other exploitation of children in the
manufacturing and delivery of its products or services;
(d) Such party (i) is duly organized, validly existing and in good
standing under the laws of the state in which it is organized, (ii) has the
power and authority and the legal right to own and operate its property and
assets, and to carry on its business as it is now being conducted, and (iii) is
in compliance with all requirements of Applicable Law, except to the extent that
any noncompliance would not materially adversely affect such party's ability to
perform its obligations under the Agreement;
(e) Such party (i) has the power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder and
thereunder and (ii) has taken all necessary action on its part to authorize the
execution and delivery of the Agreement and the performance of its obligations
hereunder. The Agreement has been duly executed and delivered on behalf of such
party, and constitutes a legal, valid, binding obligation, enforceable against
such party in accordance with its terms;
(f) All necessary consents, approvals and authorizations of all agencies
and other persons required to be obtained by such party in connection with the
Agreement have been obtained; and
(g) The execution and delivery of this Agreement and the performance of
such party's obligations hereunder (i) do not conflict with or violate any
requirement of Applicable Laws or any material contractual obligation of such
party and (ii) do not materially conflict with, or constitute a material default
or require any consent under, any material contractual obligation of such party.
8.4 LIMITATIONS. THE WARRANTIES SET FORTH IN THIS ARTICLE 8 ARE THE SOLE
WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER
WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING
WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT.
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ARTICLE 9
CONFIDENTIAL INFORMATION
9.1 Nondisclosure. During the Term of this Agreement and for a period of three
(3) years after the expiration or termination of this Agreement, neither party
shall:
(a) disclose, publish or otherwise make available (orally or in writing)
any Confidential Information of the other party to any third party (including
any employee of the receiving party without a need to know or to have access to
such Confidential Information or who does not agree to be bound by these terms),
except as required by Applicable Laws; or
(b) use any Confidential Information of the other party except in
connection with performance of this Agreement or upon express prior written
consent of the other party.
9.2 Confidential Information. For purposes of this Agreement, "Confidential
Information" means all information disclosed by a party at any time in
connection with this Agreement, except for any information which the receiving
party can establish by competent written evidence (a) was known to the receiving
party at the time of disclosure by the disclosing party, (b) was generally
available to the public at the time of disclosure by the disclosing party, (c)
after disclosure by the disclosing party, became generally available to the
public other than in breach of this Article, (d) after disclosure by the
disclosing party, became known to the receiving party from a third party
lawfully disclosing such information, or (e) is required to be disclosed by a
court of competent jurisdiction or a Federal or state administrative agency (but
only to the extent that such disclosure is required to be made and provided that
prior to making any such legally required disclosure, the party making such
disclosure shall give the other party as much prior notice of the requirement
for and the contents of such disclosure as is practicable under the
circumstances).
ARTICLE 10
INTELLECTUAL PROPERTY
10.1 Authorship and Copyright / Ownership of Materials. BCI shall own all
right, title and interest, including copyright and/or patent, in all original
works of authorship fixed in any tangible medium of expression, including but
not limited to enduring materials and graphic representations, created by
Cardinal Health under this Agreement which solely and specifically relate to the
Product, except to the extent that Cardinal Health has advised BCI that any such
interest is already owned by a third party. For all such original works and
intellectual property specifically created for BCI under this Agreement,
Cardinal Health agrees to provide documentation satisfactory to BCI to assure
the conveyance, where necessary, of such right, title and interest, including
copyrights or patents to BCI. If such information includes materials previously
developed or copyrighted by Cardinal Health and not developed under this
Agreement, Cardinal Health grants and agrees to grant to BCI and to all
companies owned directly or indirectly by BCI, severally, a royalty-free license
to use and copy such materials solely for the purpose of providing the Medical
Education Services. Upon termination, materials specifically created by Cardinal
Health for BCI, when paid for by BCI, shall be and remain BCI's property.
16
10.2 Limited Patent License. Cardinal Health recognizes that BCI owns sole and
exclusive rights in the United States to patents that cover the Product and its
method of manufacture and desires to use such patent rights in carrying out its
obligations under this Agreement. BCI grants no licenses to Cardinal Health
under patents owned by or licensed to BCI except to the extent necessary for
Cardinal Health to carry out its obligations under the specific terms of this
Agreement.
10.3 Limited Trademark License. Cardinal Health recognizes that BCI owns sole
and exclusive rights in the trademark Hectorol(R) in respect of the Product and
desires to use such trademark pursuant to carrying out its obligations under
this agreement. BCI hereby grants to Cardinal Health a license to the trademark
Hectorol(R) solely in association with the use, marketing and sales of the
Product in accordance with the terms and conditions of this Agreement to: (i)
use the Marks; (ii) use, copy, reproduce, display, transmit, distribute the
materials prepared for use in provision of Medical Education Services; and (iii)
if agreed to by BCI on a case by case basis, modify, enhance, adapt, make
derivative works of, translate and convert the Medical Education Services.
10.4 Limitation on Patent and Trademark Licenses. The licenses granted pursuant
to paragraphs 11.2 and 11.3 shall be fully paid and nonexclusive, shall be
limited to licensed uses within the United States, and shall terminate upon
termination of this Agreement. Cardinal Health shall have no right to (i) assign
any such license rights without the written consent of BCI, (ii) manufacture
product under this Agreement for any purposes, or (iii) sublicense to any
persons any licenses granted pursuant to this paragraph. Except as expressly
provided herein or required for Cardinal Health's performance of this Agreement,
BCI does not grant to Cardinal Health under this Agreement a license, either
expressed or implied, to make use, sell, offer for sale, or import products
under any intellectual property rights, including, but not limited to patent and
trademark rights, owned by or licensed to BCI.
ARTICLE 11
INSURANCE
11.1 Cardinal Health.
(a) During the Term of this Agreement, Cardinal Health shall obtain and
maintain the following insurance with limits not less than those specified below
(i) Commercial General Liability insurance with a limit of One
Million Dollars ($1,000,000) per occurrence.
(ii) Worker's Compensation and Employers Liability Insurance with
statutory limits for Workers' Compensation and Employers' Liability limits of
One Million Dollars ($1,000,000) per accident.
(iii) Professional Services Liability insurance with a limit of Two
Million Dollar ($2,000,000) per claim.
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(b) Cardinal Health may self-insure any or a portion of the required
insurance. In the event that any of the required policies of insurance are
written on a claims made basis, then such policies shall be maintained during
the entire term of this Agreement and for a period of not less than five (5)
years following the termination or expiration of this Agreement.
(c) Cardinal Health shall waive subrogation rights against BCI for
workers' compensation benefits and shall obtain a waiver from any insurance
carriers with which Cardinal Health carries workers' compensation insurance
releasing their subrogation rights against BCI.
(d) Cardinal Health shall furnish certificates of insurance to BCI
evidencing the required insurance upon request. Such certificates shall state
that Cardinal Health's insurers will endeavor to provide thirty (30) days
written notice of any cancellation prior to the policy(ies) expiration date(s).
Each insurance policy that is required under this Section shall be obtained from
an insurance carrier with an A.M. Best rating of at least A- VII.
11.2 BCI.
(a) During the Term of this Agreement, BCI shall obtain and maintain the
following insurance with limits not less than those specified below.
(i) Commercial General Liability insurance with a limit of One
Million Dollars ($1,000,000) per occurrence.
(ii) Products and Completed Operations Liability insurance with a
limit of Ten Million Dollars ($10,000,000) per occurrence.
(iii) Worker's Compensation and Employers Liability Insurance with
statutory limits for Workers' Compensation and Employers' Liability limits of
One Million Dollars ($1,000,000) per accident.
(b) In the event that any of the required policies of insurance are
written on a claims made basis, then such policy(ies) shall be maintained during
the entire period of this Agreement and for a period of not less than five (5)
years following the termination or expiration of this Agreement.
(c) BCI shall waive subrogation rights against Cardinal Health for
workers' compensation benefits and shall obtain a waiver from any insurance
carriers with which BCI carries workers' compensation insurance releasing their
subrogation rights against Cardinal Health.
(e) BCI shall furnish certificates of insurance to Cardinal Health
evidencing the required insurance upon request. Such certificates shall state
that BCI's insurers will endeavor to provide thirty (30) days written notice of
any cancellation prior to the policy(ies) expiration date(s). Each insurance
policy which is required under this Section shall be obtained from an insurance
carrier with an A.M. Best rating of at least A- VII.
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ARTICLE 12
INDEMNIFICATION
12.1 Definitions. As used in this Article 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
by any third party.
12.2 Indemnification by Cardinal Health. Cardinal Health shall indemnify and
hold BCI, its Affiliates, directors, officers, employees and agents harmless
from and against any and all Damages (except to the extent such damages arise
from BCI's negligence, willful misconduct, or breach of this Agreement) to the
extent such Damages arise directly or indirectly from:
(a) Cardinal Health's breach of this Agreement, including without
limitation, breach of any representation, warranty, or covenant made by Cardinal
Health in this Agreement;
(b) Any negligence or willful misconduct on the part of Cardinal Health
or its employees or agents; or
(c) Any federal or state claim or assessment for nonpayment or late
payment by Cardinal Health of any tax or contribution based on the status of any
Representatives as employees of Cardinal Health.
12.3 Indemnification by BCI. BCI shall indemnify and hold Cardinal Health and
its Affiliates, directors, officers, employees and agents harmless from and
against any and all Damages (except to the extent that (i) such damages arise
from Cardinal Health's negligent acts or omissions, willful misconduct or breach
of this Agreement, or (ii) Cardinal Health is precluded from indemnification
from BCI for such Damages under another agreement between the parties or between
the BCI and an Affiliate of Cardinal Health within the PTS segment of Cardinal
Health relating to the Product) to the extent such Damages arise directly or
indirectly from:
(a) BCI's breach of this Agreement, including without limitation, breach
of any representation, warranty, or covenant made by BCI in this Agreement;
(b) Any negligence or willful misconduct on the part of BCI or its
employees or agents;
(c) Detailing of the Products, except to the extent such Damages arise
from a negligent or wrongful act or omission of Cardinal Health.
(d) The accuracy or completeness of the Product Labels, Product
Promotional Materials, or the Training Program;
19
(e) The manufacture, testing, marketing, sale, shipping, distribution,
possession or use of the Products, or a manufacturing design or defect of the
Products, or any failure to warn or inadequacy of warning regarding the
Products;
(f) BCI's failure to pay when due or to reimburse Cardinal Health for
any Taxes;
(g) Any negligent acts or omissions on the part of BCI with respect to
Cardinal Health's employees or Representatives or those individuals who have
made application to be Representatives of Cardinal Health;
(h) Any federal or state claim or assessment for nonpayment or late
payment by BCI of any tax or contribution based on the status of any former
Representatives hired as employees or agents of BCI;
(i) Any intellectual property infringement actions (including patent,
trademark, service xxxx, copyright trade dress, trade secret and other
proprietary rights) brought by a third party in connection with Cardinal
Health's services under this Agreement; or
12.4 Indemnification Procedures. A party (the "Indemnitee") which intends to
claim indemnification under this Article shall promptly notify the other party
(the "lndemnitor") in writing of any action, claim or liability in respect of
which the lndemnitee 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 lndemnitee'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.
ARTICLE 13
LIMITATIONS OF LIABILITY
13.1 Special Damages. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY
SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES ARISING
DIRECTLY OR INDIRECTLY OUT OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.
13.2 Total Cap. NOTWITHSTANDING ANY OTHER PROVISION IN THIS AGREEMENT, IN NO
EVENT SHALL CARDINAL HEALTH'S TOTAL LIABILITY UNDER THIS AGREEMENT EXCEED, IN
THE AGGREGATE, FIVE MILLION DOLLARS, EXCEPT THAT CARDINAL HEALH'S LIABILITY
SHALL NOT BE CAPPED TO THE EXTENT THAT ANY LIABILITY ARISES AS A RESULT OF THE
GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF CARDINAL HEALTH.
20
13.3 Applicability. THE LIMITATIONS OF LIABILITY CONTAINED IN THIS ARTICLE 13
SHALL NOT AFFECT PROVISIONS ON THE LIMITATIONS ON LIABILITY CONTAINED IN ANY
OTHER AGREEMENTS BETWEEN THE PARTIES.
ARTICLE 14
TERM AND TERMINATION
14.1 Term. The Term of this Agreement shall commence as of the Effective Date
stated on the first page of this Agreement and shall continue through June 30,
2008 (the end of Fiscal Year 2008) ("Term").
14.2 Termination. Subject to the terms of Section 14.4, either party may
terminate this Agreement:
(a) Immediately upon written notice to the other party in the event 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; or
(b) Due to a material breach by the other party of its obligations under
this Agreement, provided that such breach has not been cured within thirty (30)
days after notice thereof from the non-breaching party; or
(c) On thirty (30) days prior written notice to the other party, if the
Product is not being marketed due to regulatory problems, court or
administrative proceedings, product liability claims, or recalls, provided,
however, that the party terminating under this section shall not be entitled to
do so if any of the foregoing reasons for termination are the result of the
terminating party's negligence or willful misconduct, whether under this
Agreement or under any other agreement between the parties;
(d) Due to a Change in Control, upon thirty (30) days prior written
notice to the other party; or
(e) Following the completion of Q2 of Fiscal Year 2005 in the event that
the Quarterly Net Sales in any two quarters within a given 12 month period are
fifty percent (50%) or more less than the Forecasted Quarterly Net Sales for
those Fiscal Quarters as set forth in Schedule 6.1; provided that (i) written
notice is given during the quarter following the second of the said two quarters
and (ii) if Quarterly Net Sales of the Product during the quarter following the
second of the said two quarters improve to be greater than 50% of the Forecasted
Quarterly Net Sales for that quarter, the Agreement may be terminated by BCI
only if Cardinal Health provides its written agreement to such termination..
21
For purposes of this Section, a "Change in Control" means any transaction or
series of transactions which results in (i) direct or indirect ownership of more
than 50% of the voting stock of either party by persons who are not an Affiliate
of that party as of the date of this Agreement, or (ii) transfer in ownership of
or license of the Product to any third-party entity other than BCI or an entity
that is an Affiliate of BCI as of the date of this Agreement that has assumed
all of BCI's obligations under this Agreement.
14.3 Effect of Termination.
(a) Compensation. The termination or expiration of this Agreement shall
not affect either party's obligation to reimburse or pay the other party any
amount then due and owing to the other party under this Agreement.
(b) Confidential or Other Information. Upon termination or expiration of
this Agreement, the Parties shall return or destroy all Confidential Information
of the other. Cardinal Health also must return all Product Promotional Materials
and Product samples.
14.4 Early Termination/ Buyout.
(a) Liquidated Damages. BCI and Cardinal Health acknowledge that
Cardinal Health would suffer damages upon early termination of this Agreement
and such damages would be difficult to ascertain and are not susceptible of
ready proof. As a result, the Parties agree that the Termination Fees set forth
in this Section are a reasonable estimation of Cardinal Health's expenses in
preparing to perform under this Agreement, its expectancy interest and damages
upon early termination of this Agreement by BCI, and shall not be construed or
deemed to be a penalty.
(b) Additional Termination Rights, Termination by BCI, and Termination
Fee. BCI shall have the right to terminate this Agreement without cause upon
ninety (90) days prior written notice to Cardinal Health. In the event that BCI
terminates this Agreement without cause in accordance with the terms of this
subsection or if BCI terminates this Agreement pursuant to Section 14.2(c), BCI
agrees to pay Cardinal Health a "Termination Fee" calculated as set forth in
Schedule 14.4(b), provided, however, that BCI shall not be obligated to pay the
Termination Fee if BCI terminates pursuant to Section 14.2(c) due to regulatory
problems, product liability claims or recalls that are the result of Cardinal
Health's or one its Affiliates' negligence or willful misconduct. Such
Termination Fee shall be paid in full within 12 months of the date of
termination in four equal quarterly installments, the first of which shall be
paid within fifteen (15) days of termination of this Agreement.
(c) Termination by Cardinal Health. In the event of termination of this
Agreement by Cardinal Health pursuant to Section 14.2(a), Section 14.2(b), or
Section 14.2(c), BCI shall be obligated to pay to Cardinal Health the
Termination Fee, provided, however, that BCI shall not be obligated to pay the
Termination Fee if BCI terminates pursuant to Section 14.2(c) due to regulatory
problems, product liability claims or recalls that are the result of Cardinal
Health's or one its Affiliates' negligence or willful misconduct. Payment of the
Termination Fee due under
22
this Section shall be due within 12 months of the termination of this Agreement
in four equal quarterly installments, the first of which shall be paid within
fifteen (15) days of termination of this Agreement.
14.5 Change in Control.
(a) If neither party terminates this Agreement due to a Change in
Control in accordance with Section 14.2(d), then, notwithstanding Section 15.9,
this Agreement shall be binding upon and inure to the benefit of the parties,
their successors and assigns, including without limitation any successor owner,
licensee or sublicensee of the Product.
(b) In the event Cardinal Health terminates this Agreement due to a
Change in Control of BCI in accordance with Section 14.2(d), BCI shall have the
right to hire the Representatives upon payment of the Contract Sales Services
Buyout Fee set forth in Schedule 5.7(c), but shall not be required to pay the
Termination Fee. If BCI chooses not to hire the Representatives, BCI shall not
be obligated to pay the Termination Fee or the Contract Sales Services Buyout
Fee set forth in Schedule 5.7(c), but BCI shall instead pay a fee equal to
thirty-three percent (33%) of the aggregate base salaries of all
Representatives.
(c) In the event BCI terminates this Agreement due to a Change in
Control of BCI in accordance with Section 14.2(d), BCI and/or its successors or
assigns shall pay the Termination Fee. Payment of the Termination Fee due under
this Section shall be due within 12 months of the termination of this Agreement
in four equal quarterly installments, the first of which shall be paid within
fifteen (15) days of termination of this Agreement.
(d) In the event either party terminates this Agreement due to a Change
in Control of Cardinal Health in accordance with Section 14.2(d), BCI shall have
the right to hire the Representatives upon payment of the Contract Sales
Services Buyout Fee set forth in Schedule 5.7(c), but shall not be required to
pay the Termination Fee. If BCI chooses not to hire the Representatives, BCI
shall not be obligated to pay the Termination Fee, the Contract Sales Service
Buyout Fee or any other fee related to termination of this Agreement.
(e) The non-solicitation terms in Section 5.7(e) shall apply to any
Representative not hired by BCI upon termination of this Agreement due to a
Change in Control of BCI.
ARTICLE 15
MISCELLANEOUS
15.1 Cardinal Health Independent Contractor. Cardinal Health is being retained
and shall perform hereunder strictly as an independent contractor.
Representatives of Cardinal Health performing services hereunder shall not be,
and shall not be considered to be, employees of BCI for any purpose, and shall
at all times remain employees of Cardinal Health. 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. Nothing contained in this Agreement shall be
construed as creating a joint venture or, except as
23
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.
15.2 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.
The remedies herein provided are cumulative and not exclusive of any remedies
provided by law.
15.3 Captions. Article and Section headings used in this Agreement are for
convenience only and shall not affect the construction of this Agreement.
15.4 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.
15.5 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 unenforceable 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.
15.6 Entire Agreement: Modification. This Agreement contains the entire
agreement between the Parties and supersedes all prior or contemporaneous
discussions, negotiations, representations, warranties, or agreements relating
to the subject matter of this Agreement. No changes to this Agreement will be
made or be binding on either party unless made in writing and signed by each
party.
15.7 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 (i) pre-paid registered or certified mail, (ii) facsimile
transmission, or (iii) a reliable overnight delivery service 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. The date of
receipt shall be deemed to be the effective date on which notice was given,
provided that all facsimile transmissions shall contain a provision requiring
the intended recipient to confirm receipt and no facsimile transmission shall be
effective unless confirmation of its receipt is received within twenty-four
hours of its transmission.
All notices shall be addressed to:
24
If to BCI, to:
Bone Care International, Inc.
Bone Care Center
0000 Xxxxx Xxxxxxx
Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
Attention: President
to Cardinal Health, to:
Cardinal Health
Healthcare Marketing Services
0000 Xxxxxx Xxxx
Xxxxx, Xxx Xxxxxx 00000
Fax: (000) 000-0000
Attention: President
with a copy to:
Cardinal Health
0000 Xxxxxxxx Xxxxx
Xxxxxx, Xxxx 00000
Fax: (000) 000-0000
Attention: Associate General Counsel,
Pharmaceutical Technologies and Services
15.8 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.
15.9 Assignment. Except as provided in Section 14.5, this Agreement may not be
assigned or transferred by either party without the prior written consent of the
other party hereto. Any such assignment shall not materially or adversely affect
the rights or obligations of either party to this Agreement.
15.10 Public Announcements. Neither party will make any press release or other
public disclosure regarding this Agreement or the transactions contemplated
hereby without the other party's express prior written consent, except as
required under applicable law or by any governmental agency, in which case the
party required to make the press release or public disclosure shall use
commercially reasonable efforts to obtain the approval of the other party as to
the form, nature and extent of the press release or public disclosure prior to
issuing the press release or making the public disclosure.
15.11 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,
00
xxxx, xxxxxxxx, xxxxxxx, 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.
15.12 Survival. The obligations set forth in Sections 4.6, 5.7 and 5.8 and
Articles 1, 6, 7, 9, 10, 11, 12, 13, 14, and 15 and any other terms or
provisions expressly or implicitly intended to survive the expiration or
termination of this Agreement, shall survive the expiration or termination of
this Agreement.
15.13 Alternative Dispute Resolution. If a dispute, controversy or disagreement
("Dispute") arises between the Parties in connection with this Agreement, then
the Dispute shall be presented to the respective presidents or senior executives
of Cardinal Health and BCI for their consideration and resolution. If such
Parties cannot reach a resolution of the Dispute, then such Dispute shall be
resolved by arbitration in accordance with the then existing commercial
arbitration rules of The CPR Institute for Dispute Resolution ("CPR"), 000
Xxxxxxx Xxxxxx, Xxx Xxxx, XX 00000. Arbitration shall be conducted in the
jurisdiction of the defendant party.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their duly authorized officers.
CARDINAL HEALTH PTS, LLC BONE CARE INTERNATIONAL, INC.
By: /S/ XXXXXX X. XXXXXXX By: /S/ XXXX X. XXXXX
----------------------------- ---------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxx X. Xxxxx
Title: President, Healthcare Marketing Services Title: President and CEO
Date: July 13, 2004 Date: July 14, 2004
26
SCHEDULE 2.1(c)
DECREASE IN PROMOTIONAL SPEND
PERCENTAGE BY WHICH THE QUARTERLY NET
SALES IN ANY FISCAL QUARTER IS LESS THAN
THE FORECASTED QUARTERLY NET SALES FOR DECREASE IN CARDINAL DECREASE IN BCI
THE SAME FISCAL QUARTER PROMOTIONAL SPEND PROMOTIONAL SPEND
***% ***% ***%
***% ***% ***%
***% ***% ***%
***% ***% ***%
***% ***% ***%
***% ***% ***%
***% ***% ***%
***% ***% ***%
***% OR MORE ***% ***%
27
SCHEDULE 3.1
CARDINAL FLEXIBLE PROMOTIONAL SPEND
FISCAL YEAR 2005
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2006
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2007
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2008
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
The total amount of the Cardinal Promotional Spend as set forth on this Schedule
is determined by taking Cardinal Health's fully burdened standard fees for
Medical Education Services or other services provided by Cardinal Health upon
request of the JCC and includes the total cost of any Direct Expenses that would
ordinarily be due in connection with such services. For example, in Q1 of 2005,
the total Cardinal Promotional Spend according to this Schedule is $***. If the
Direct Expenses for services to be provided by Cardinal during Q1 are expected
to be $***, the maximum fully burdened value of flexible promotion services that
Cardinal Health would be required to provide is $***, plus the $*** in
pass-through expenses, for a total required Cardinal Promotional Spend of $***
in Q1 of 2005.
28
SCHEDULE 3.2
BCI PROMOTIONAL SPEND
FISCAL YEAR 2005
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2006
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2007
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2008
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
29
SCHEDULE 5.1
CONTRACT SALES SERVICES
Cardinal Health shall provide a total of twenty-five (25) Representatives to
provide the Contract Sales Services as provided in this Agreement. Cardinal
Health's total cost to provide such services, which cost shall be borne by
Cardinal Health as provided in this Agreement, is set forth in the following
table:
FISCAL YEAR 2005
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2006
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2007
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
FISCAL YEAR 2008
Q1 Q2 Q3 Q4
---- ---- ---- ----
$*** $*** $*** $***
The foregoing amounts include approximately $*** to upgrade BCI's sales force
automation hardware system. The Parties shall mutually agree upon the hardware
to be upgraded and the specific hardware that will be purchased to replace such
hardware. Upon expiration or termination of this Agreement for any reason
whatsoever, BCI shall pay to Cardinal Health the actual cost remaining on
Cardinal Health's books (i.e., net of depreciation) for the hardware (e.g.
personal computers, printers and handhelds) ("Book Value") utilized by the
Representatives at the time of such expiration or termination.
30
SCHEDULE 5.3
ALLOCATION OF RESPONSIBILITIES FOR
CONTRACT SALES SERVICE ACTIVITIES
1. Cardinal Health will recruit, interview and hire as its employees the
Representatives. Cardinal Health will ensure that Representatives have prior
experience and training in pharmaceutical sales or such other experience deemed
mutually acceptable by BCI and Cardinal Health. The Representatives shall have a
minimum of a four (4) year degree from a college or university, three or more
years of prior pharmaceutical sales experience, shall be professional in manner
and appearance, and shall be hired in accordance with all applicable state and
federal laws. Each Representative shall have a valid driver's license for
purposes of performing his/her obligations under this Agreement. Cardinal Health
shall ensure that the Representatives have satisfactory references from prior
employers. Cardinal Health shall have the sole authority to reject any applicant
for employment as a Representative. BCI may, at its sole cost and expense,
participate with Cardinal Health in the interviewing of Representatives, and
Cardinal Health shall not hire any Representative without the prior approval of
BCI; provided, however, that if Cardinal Health rejects an applicant for
Representative and gives written notice thereof to BCI and thereafter Cardinal
Health hires such applicant at the request of BCI, BCI shall indemnify for and
hold Cardinal Health harmless from any Damages arising as a result of such
Representative's wrongful or negligent acts or omissions.
2. Cardinal Health shall have sole and exclusive authority to discipline or
terminate the employment of Representatives. BCI may request that a
Representative be terminated or reassigned at any time, provided that such
termination or reassignment is consistent with Cardinal Health policies and
procedures and would not be in violation of any Applicable Laws. Cardinal Health
shall comply with such request; provided that such action complies with
Applicable Laws and is in accordance with Cardinal Health's policies and
procedures, as determined by Cardinal Health's human resources manager. In the
event Cardinal Health determines that its policies and procedures or Applicable
Laws prohibit the termination or reassignment of any Representative so requested
by BCI, it shall notify BCI of such determination and submit a corrective action
plan for BCI approval.
3. Cardinal Health shall cause each Representative to attend and successfully
complete the Training Program conducted by BCI for the Products prior to
participating in the Contract Sales Services. 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.
4. BCI shall provide a copy of its evaluations of the Representatives to
Cardinal Health.
5. BCI shall provide Cardinal Health without cost with sufficient quantities
of the Product Promotional Materials (to be included in the BCI Promotional
Spend) and Product Labeling for the performance and supervision of Detailing.
BCI 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
31
only the Product Labeling and the Product Promotional Materials provided by BCI;
and under no circumstances shall Cardinal Health or the Representatives develop,
create, or use any other promotional material or literature for the Detailing of
the Products. BCI shall advise Cardinal Health immediately of any inaccuracy or
incompleteness of the Product Promotional Materials or the Product Labeling, and
upon such notice Cardinal Health and the Representatives shall immediately cease
the use of any portion or all of the Product Promotional Materials or Product
Labeling so identified by BCI. Cardinal Health's Representatives will not make
any statement that is inconsistent with the Product Promotion Materials.
6. Cardinal Health 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 BCI or any of its
Affiliates, employees, competitors, or competing products. Representatives shall
Detail the Products in strict adherence to all Applicable Laws, the Act, the
Medicare and Medicaid Anti-Kickback Statute, the American Medical Association
Gifts to Physicians from Industry Guidelines, the standards and guidelines
outlined in the PhRMA Code, and the standards and guidelines outlined in the OIG
Guidance ("Industry Standards"). Cardinal Health also shall ensure that the
Representatives understand the HIPAA privacy standards and the need to maintain
the confidentiality of any individually identifiable health information that may
inadvertently be disclosed to them during Product Detailing.
7. The Representatives shall remain under the direct authority and control of
Cardinal Health, but shall cooperate with the members of BCI and shall receive
advice and direction related to Detail activities on the Products from BCI and
Cardinal Health mutually. The JCC shall make all decisions with respect to the
overall strategy in connection with the Detailing of the Products. Any BCI
personnel interacting with Cardinal Health 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. BCI shall provide Cardinal
Health with copies of all reports, memoranda, audits and other data it develops
pertaining to the Representatives, Detailing, and the Contract Sales Services
within fifteen (15) days of the completion of such documents; provided, however,
that any such documents claiming negligent or wrongful acts or omissions of
Representatives shall, as provided in Section 5.5 of the Agreement, be sent to
Cardinal Health as promptly as practicable and nothing within this Section 7
shall be construed to require disclosure of any materials protected by the
attorney-client privilege.
8. BCI shall provide Cardinal Health with a list of Target Physicians and
with data on prescriptions and sales for Cardinal Health's use in performing
this Agreement. BCI shall also provide Cardinal Health with such other sales and
marketing information concerning the Products that is obtained or prepared
during the Term of this Agreement.
9. Training Programs.
32
(a) BCI shall conduct a suitable training program for the
Representatives prior to the commencement of the Contract Sales Services, which
shall include such medical and technical information about the Products and such
sales training as BCI, along with Cardinal Health, deems necessary and
appropriate (the "Training Program"). The Training Program shall also include
instruction on compliance with Applicable Laws and Industry Standards. Cardinal
Health shall assist BCI with the Training Program only to the extent requested
by BCI. Representatives shall adhere to the instructions provided in the
Training Program in their Detailing efforts.
(b) In order to qualify for assignment in a territory, a Representative
must demonstrate thorough knowledge of the Products by passing BCI approved
Product tests at a level of proficiency agreed upon by BCI and Cardinal Health.
(c) Training Materials. BCI 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
(d) BCI Assistance. During the Term of this Agreement, BCI shall make
available to Cardinal Health, without cost, a reasonable number of, and for a
reasonable amount of time, BCI's sales training and marketing personnel to
assist Cardinal Health's Representatives with respect to the Training Program
and additional orientation and ongoing training for the Representatives.
10. Samples.
(a) Provision of Samples. BCI shall provide samples of the Products to
the Representatives at BCI's option and at its expense. BCI 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 BCI elects to have Cardinal
Health manage the storage and distribution of samples, Cardinal Health shall
pass on to BCI 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 BCI and Cardinal Health in compliance with the
PDMA and all other Applicable Laws.
(b) Sample Accountability. Cardinal Health shall prepare and provide to
BCI for approval a sample accountability program applicable to the samples
provided by BCI.
(c) Return of Samples. Within 30 days following the termination or
expiration of this Agreement or within 30 days from the termination or removal
of a Representative (unless such Representative has been hired or retained by
BCI), Cardinal Health shall cause the Representatives to return to BCI all
unused Product samples provided to Cardinal Health or the Representatives by
BCI. BCI shall pay or reimburse Cardinal Health for all costs and expenses in
connection with the storage and shipment of returned samples.
33
11. Communications from Third Parties. Cardinal Health and its Representatives
shall use their best efforts to advise BCI of all comments, statements, requests
and inquiries of the medical profession or any other third parties relating to
the Products or Product claims or indications that are not addressed by either
Product Labeling or the Product Promotional Materials, of which Cardinal Health
becomes aware. All responses to such communications to the medical profession or
such other third parties shall be handled solely by BCI. Cardinal Health shall
provide reasonable assistance to BCI to the extent requested by BCI, and at
BCI's cost and expense, to fully respond to such communications.
12. BCI Communications. In addition to Detailing, Cardinal Health shall assist
BCI with respect to customer communications (as reasonably requested by BCI and
at BCI's cost and expense) and shall regularly advise BCI of market, economic,
regulatory and other developments of which Cardinal Health may become aware
which may affect the sale of the Products.
13. 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 for Contract Sales Services. Within thirty (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.
14. Review of Results. The Parties shall meet periodically, but at least once
per calendar quarter, to review and discuss the actual results compared to the
marketing plans for Detailing of the Products. BCI shall regularly and promptly
share with Cardinal Health all reports, audits and other data it develops
relative to the Program.
15. Management Reports. Cardinal Health shall provide BCI with monthly reports
in the form set forth in the table below within fifteen (15) days after the end
of each month. At the request of BCI, Cardinal Health shall furnish BCI at
reasonable times such documentation as BCI reasonably requests for purposes of
verifying the accuracy of any monthly report.
Report Name Description Frequency
---------------------------- ----------------------------------------------------------------------- ---------
Territory Assignment Report Lists the individuals covering each region and territory. If a Monthly
territory is vacant, the report will indicate the date when the
territory became vacant and what alternate coverage is being applied
(i.e. Adjacent Rep, etc.)
In addition, the report will indicate the current turnover rate.
16. Reporting of Certain Adverse Events.
(a) Immediate Notification. Cardinal Health and BCI 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
34
attributable to the Products. "Serious" as used in this Section 16(a) refers to
an experience which results in death, permanent or substantial disability,
in-patient hospitalization, prolongation of existing in-patient hospitalization,
a congenital anomaly or cancer, or a result of an overdose or life threatening
condition. "Unexpected" as used in this Section 16(a) refers to (i) conditions
or developments not previously submitted to governmental Agencies or encountered
during clinical studies of the Products and not reflected in the Product
Promotional Materials or the Product Labeling, or (ii) conditions or
developments occurring with greater frequency, severity, or specificity than
shown by information previously submitted to governmental Agencies or
encountered during clinical studies of the Products and not reflected in the
Product Promotional Materials or the Product Labeling. 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.
(b) Threatened Regulatory Action. Cardinal Health and BCI shall each
immediately notify the other party of any information that each may obtain or
learn regarding any threatened or pending action by a Regulatory Authority which
may affect the Products. Cardinal Health shall, at the request of BCI and at the
cost and expense of BCI, cooperate with BCI in formulating a procedure for
taking appropriate action in response to such information. Unless compelled by
law, Cardinal Health shall not respond to a Regulatory Authority without the
prior written consent of BCI.
(c) Training. Cardinal Health and BCI shall develop appropriate
instructions in the Training Program for Representatives as to handling of
information received or obtained subject to Sections 16(a) and 16(b) of this
Schedule.
35
SCHEDULE 5.7(c)
CONTRACT SALES SERVICES BUYOUT FEE
THE CONTRACT SALES SERVICE BUYOUT FEE SHALL BE AS FOLLOWS:
FISCAL YEAR 2005: *** PERCENT (***%) OF THE AGGREGATE BASE SALARIES OF ALL
REPRESENTATIVES
FISCAL YEAR 2006: *** PERCENT (***%) OF THE AGGREGATE BASE SALARIES OF ALL
REPRESENTATIVES
FISCAL YEAR 2007: *** PERCENT (***%) OF THE AGGREGATE BASE SALARIES OF ALL
REPRESENTATIVES
FISCAL YEAR 2008: *** PERCENT (***%) OF THE AGGREGATE BASE SALARIES OF ALL
REPRESENTATIVES
For the purposes of this Schedule 5.7(c), "base salaries" is understood to be
exclusive of benefits and bonuses.
36
SCHEDULE 6.1
CO-PROMOTION FEE
FISCAL YEAR 2005
Q1 Q2 Q3 Q4
----- ----- ----- -----
FORECASTED QUARTERLY NET SALES $*** $*** $*** $***
CO PROMOTE FEE % ***% ***% ***% ***%
CO-PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUY OUT ***% ***% ***% ***%
CO PROMOTE FEE % (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
CO PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUYOUT (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
FISCAL YEAR 2006
Q1 Q2 Q3 Q4
----- ----- ----- -----
FORECASTED QUARTERLY NET SALES $*** $*** $*** $***
CO PROMOTE FEE % ***% ***% ***% ***%
CO-PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUY OUT ***% ***% ***% ***%
CO PROMOTE FEE % (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
CO PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUYOUT (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
FISCAL YEAR 2007
Q1 Q2 Q3 Q4
----- ----- ----- -----
FORECASTED QUARTERLY NET SALES $*** $*** $*** $***
CO PROMOTE FEE % ***% ***% ***% ***%
CO-PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUY OUT ***% ***% ***% ***%
CO PROMOTE FEE % (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
37
CO PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUYOUT (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
FISCAL YEAR 2008
Q1 Q2 Q3 Q4
----- ----- ----- -----
FORECASTED QUARTERLY NET SALES $*** $*** $*** $***
CO PROMOTE FEE % ***% ***% ***% ***%
CO-PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUY OUT ***% ***% ***% ***%
CO PROMOTE FEE % (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
CO PROMOTE FEE % AFTER CONTRACT
SALES SERVICE BUYOUT (IF PRICE
NORMALIZATION APPLIES+++) ***% ***% ***% ***%
Each of the Co Promote Fee % set forth above are in the alternative and
not cumulative or additive. The determination of which of the four Co
Promote % applies will be determined in accordance with Sections 5.7(c)
and/or Section 6.5.
* Both Parties operate on a fiscal year of July 1 through June 30.
++ The Co-Promote Fee is expressed as a percentage of the Quarterly Net
Sales.
+++ Price normalization as defined in Section 6.5 applies only in a given
Fiscal Quarter in which the actual capsule volume sales of the Hectorol
2.5 mcg product exceed by ***% or more the baseline forecast projected on
a quarterly basis, where the baseline forecast for Hectorol 2.5mcg on an
annual basis is as follows:
Baseline Hectorol 2.5 mcg Capsule Forecast
Q1 Q2 Q3 Q4 Annual
-- -- -- -- ------
Fiscal Year 2005 *** *** *** *** ***
Fiscal Year 2006 *** *** *** *** ***
Fiscal Year 2007 *** *** *** *** ***
Fiscal Year 2008 *** *** *** *** ***
38
SCHEDULE 14.4(b)
TERMINATION FEE
"Termination Fee" shall be calculated as follows:
(i) If BCI hires the Representatives in accordance with this Agreement,
the Termination Fee shall include an amount equal to the Contract
Sales Force Buyout Fee set forth on Schedule 5.7(c) based on the
year of termination but if BCI chooses not to hire the
Representatives, the Termination Fee shall include an amount that is
thirty-three (33%) of the aggregate yearly base salaries (understood
to be exclusive of benefits and bonuses) of all the Representatives
provided by Cardinal Health under this Agreement and that are still
engaged by Cardinal Health at the time of such termination;
(ii) The Book Value for the sales force automation upgrade, as set forth
on Schedule 5.1; plus
(iii) An amount determined on an annualized basis that is equal to: (a)
the Cardinal Promotional Spend each fiscal year through the date of
termination of this Agreement, plus (b) an amount equal to a fifteen
percent (15%) annualized return of the Cardinal Promotional Spend
each fiscal year through the date of termination of this Agreement,
less (c) the total Co-Promote Fees actually paid by BCI each fiscal
year through the date of termination of this Agreement. For the
avoidance of doubt, the amount is determined on an annualized basis
by calculating (a) plus (b) less (c) separately on a stand-alone
basis for each fiscal year up to, and including, the fiscal year
that includes the date of termination of this Agreement. Amounts due
for any fiscal year in which the sum of (a) and (b) is more than the
Co-Promote Fees actually paid in that fiscal year shall not be
offset in any way by the result for any fiscal year in which the sum
of (a) and (b) is less than Co-Promote Fees actually paid in that
fiscal year.
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT WAS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH RULE
24b-2, PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
OMITTED INFORMATION WAS REPLACED WITH ASTERISKS.
39