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Exhibit
10.60
Execution
Copy
Portions of this exhibit
marked [ * ] are requested to be treated
confidentially.
CO-PROMOTION
AGREEMENT
This
Co-Promotion Agreement (this “Agreement”) is entered
into as of the 4th day of September, 2007, between Salix
Pharmaceuticals, Ltd., a Delaware corporation, (hereinafter
referred to as “SALIX”), and Eisai Inc., a Delaware
corporation (hereinafter referred to as
“EISAI”).
W I T N E S S E T
H:
WHEREAS,
SALIX possesses all rights necessary to manufacture, market,
promote, sell and distribute the PRODUCTS (as hereinafter defined)
in the TERRITORY (as hereinafter defined); and
WHEREAS,
EISAI employs or contracts with persons comprising a professional
sales force (“EISAI SALES FORCE”) that currently calls
on PHYSICIANS (as hereinafter defined) in order to promote
pharmaceutical products within the TERRITORY; and
WHEREAS,
SALIX desires to appoint EISAI as the exclusive third party
promoter and detailer of the PRODUCTS in the TERRITORY, and EISAI
desires to accept such appointment, all on the terms and conditions
set forth herein.
NOW,
THEREFORE, SALIX and EISAI agree as follows:
Unless
otherwise specifically provided herein, the following terms shall
have the following meanings:
(a) “AFFILIATE”
shall mean any corporation or other business entity that directly
or indirectly controls, is controlled by, or is under common
control with a PARTY. Control means (i) to possess, directly
or indirectly, the power to direct the management or policies of a
corporation or other business entity, whether through ownership of
voting securities or by contract relating to voting rights or
corporate governance, or (ii) to own, directly or indirectly,
more than fifty percent (50%) of the outstanding voting
securities or other ownership interest of such corporation or other
business entity.
(b) “APPLICABLE
LAWS” shall mean all laws, rules, and regulations applicable
to the manufacture, marketing, promotion, sale and distribution of
pharmaceutical products in the TERRITORY.
(c) “AVERAGE
UNITS PER PRESCRIPTION” shall mean:
(i) with
respect to the 750 mg capsule PRESENTATION for any period, [*],
and
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
(ii) with
respect to another PRESENTATION (A) for the initial CONTRACT
QUARTER in which such PRESENTATION is first sold in the TERRITORY,
(1) [*] for such PRESENTATION for such CONTRACT QUARTER,
divided by (2) [*] for such PRESENTATION for such CONTRACT
QUARTER; and (B) for any CONTRACT QUARTER after the initial
CONTRACT QUARTER in which such PRESENTATION is first sold in the
TERRITORY, (1) [*] for such PRESENTATION for such CONTRACT
QUARTER and the immediately preceding CONTRACT QUARTER, divided by
(2) [*] for such PRESENTATION for such CONTRACT QUARTER and
the immediately preceding CONTRACT QUARTER.
(d) “BASELINE
CONVERTED PRESCRIPTIONS” shall mean, with respect to each
CONTRACT QUARTER, [*], subject to adjustment in accordance with
Section 2.5(b).
(e) “BIOREX
ROYALTIES” shall mean, with respect to a PRESENTATION for any
period, the actual amount of royalties payable by SALIX to Biorex
Laboratories Limited with respect to sales of such PRESENTATION in
the TERRITORY with respect to such period pursuant to the Amended
and Restated License Agreement dated April 16, 1993, as
amended to the date hereof, between SALIX and Biorex Laboratories
Limited (the “BIOREX AGREEMENT”).
(f) “CONTRACT
QUARTER” shall mean the 3-month period beginning on
October 1, 2007 and ending December 31, 2007 and each
3-month period thereafter beginning each
January 1, March 1, July 1 and
October 1; provided that the final CONTRACT QUARTER shall end
on the date of termination of this Agreement.
(g) “CONTRACT
YEAR” shall mean each 12-month period beginning
January 1 and ending December 31; provided that the first
CONTRACT YEAR shall begin on October 1, 2007 and end
December 31, 2007 and the final CONTRACT YEAR shall end on the
date of termination of this Agreement.
(h) “CONVERTED
PRESCRIPTIONS”, with respect to a PRESENTATION for any
period, shall have the meaning set forth on, and shall be
determined in accordance with the procedures set forth on, Appendix
C.
(i) “COST
OF GOODS SOLD” shall mean, with respect to a PRESENTATION for
any period, SALIX’s actual cost of manufacture or acquisition
of all quantities of such PRESENTATION sold in the TERRITORY, or
with respect to SAMPLES, sold to EISAI, during such period,
calculated in accordance with GAAP and consistent with
SALIX’s past practice, but expressly excluding (i) any
selling, general and administrative expenses of SALIX and
(ii) any markup of any kind on amounts paid to THIRD
PARTIES.
(j) “DEBARRED
PERSON” shall mean any person (i) debarred or suspended
under Section 306 of the FD&C ACT or (ii) listed in
the Department of Health and Human Services List of Excluded
Individuals/Entities or the General Services Administration’s
Listing of Parties excluded from Federal Procurement and
Non-Procurement Programs.
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
(k) “DETAIL”
shall mean that part of a sales call by a professional sales
representative to a PHYSICIAN in the TERRITORY during which such
professional sales representative makes a presentation about a
PRODUCT (which sales call may, or may not, include a presentation
about other products as well) in which key attributes and
characteristics of such PRODUCT are verbally presented to the
PHYSICIAN along with MARKETING MATERIALS (as defined below). When
used as a verb, “DETAIL” means to engage in a
DETAIL.
(l) “FDA”
shall mean the U.S. Food and Drug Administration.
(m) “FIELDS
OF USE” shall mean all indications for the
PRODUCTS.
(n) “GAAP”
shall mean generally accepted accounting principles in the United
States consistently applied.
(o) “GRANULATED
MESALAMINE PRODUCT” shall mean any pharmaceutical product
containing mesalamine as the sole active ingredient in a
formulation consisting of granules of coated mesalamine in a
capsule shell.
(p) “NET
SALES” shall mean, with respect to a PRESENTATION for any
period, the gross invoiced sales price for all quantities of such
PRESENTATION sold by SALIX, its AFFILIATES and licensees in the
TERRITORY during such period, less (i) sales taxes or other
taxes included in the gross invoice price; (ii) actual
shipping and insurance costs paid to a THIRD PARTY;
(iii) actual credits or refunds for returned or defective
PRODUCTS (but excluding any credits or refunds for quantities of
such PRESENTATION in connection with any RECALL of such
PRESENTATION, unless, and to the extent, that such RECALL results
from a breach of this Agreement by EISAI); (iv) trade
discounts and quantity discounts or retroactive price reductions;
and (v) rebates, credits, and chargeback payments (or the
equivalent thereof) actually granted to managed health care
organizations, wholesalers, or to federal, state, local and other
governments, including their agencies, purchasers, and/or
reimbursers, or to trade customers, calculated in accordance with
GAAP and consistent with SALIX’s past practice. All PRODUCTS
will be considered “sold” upon first use, shipment,
invoicing or receipt of payment therefor, whichever shall first
occur. Notwithstanding the foregoing, NET SALES shall not include,
and shall be deemed zero with respect to, (i) the actual
distribution of SAMPLES as provided herein; or (ii) all
PRODUCTS provided for clinical trials or research purposes at cost
or at no charge.
(q) “NO-FAULT
SUPPLY DISRUPTION” shall mean a failure of SALIX to fulfill
customer orders for PRODUCT due to fire, floods, embargoes, war,
acts of war (whether war be declared or not), insurrections, riots,
civil commotions, strikes, lockouts or other labor disturbances, or
acts of God affecting SALIX or a THIRD PARTY that supplies PRODUCTS
(or any component thereof) to SALIX.
(r) “PARTY”
shall mean SALIX or EISAI, as the case may be.
(s) “PHAST”
shall mean WOLTERS KLUWER’s Source Pharmaceutical Audit Suite
database.
(t) “PHYSICIAN(S)”
shall mean doctors of medicine or osteopathy who are legally
authorized to prescribe the PRODUCTS with a primary practice office
location in the TERRITORY, which includes the evaluation and
treatment of conditions of the gastrointestinal system, including
primary care physicians and gastroenterologists. PHYSICIAN(S) shall
also include nurse practitioners, physician assistants, and other
mid-level practitioners who are legally authorized to prescribe the
PRODUCTS and who evaluate and treat conditions of the
gastrointestinal system.
(u) “PRESENTATION”
shall mean each separate formulation (or delivery form) of the
PRODUCTS in each separate dosage strength of such formulation (or
delivery form). For illustrative purposes only, each of the
following would be a separate PRESENTATION: (i) PRODUCT in 750
mg capsules, (ii) PRODUCT in 1000 mg capsules,
(iii) PRODUCT in 1100 mg tablets, and (iv) PRODUCT in 500
mg per 5 ml oral suspension.
(v) “PRESENTATION
RATIO” shall mean, with respect to a PRESENTATION for any
period, (i) CONVERTED PRESCRIPTIONS for such PRESENTATION for
such period, divided by (ii) TOTAL PRESCRIPTIONS for such
period.
(w) “PRODUCT”
shall mean any pharmaceutical product containing balsalazide
disodium as the sole active ingredient thereof, in any dosage,
formulation (or delivery form), that is marketed, distributed or
sold by SALIX, its AFFILIATES or licensees during the TERM under a
TRADEMARK pursuant to a New Drug Application or Abbreviated New
Drug Application approved by the FDA, and “PRODUCTS”
shall mean all such products collectively. For the avoidance of
doubt, “PRODUCT” shall not include any authorized
generic version of a PRODUCT marketed, distributed or sold by
SALIX, its AFFILIATES or licensees provided that such authorized
generic version is not marketed, distributed or sold under a
TRADEMARK.
(x) “PROFIT
PER PRESCRIPTION” shall mean, with respect to a PRESENTATION
for any period, the product of (i) PROFIT PER UNIT for such
PRESENTATION for such period, multiplied by (ii) AVERAGE UNITS
PER PRESCRIPTION for such PRESENTATION for such period. An example
of this calculation is provided in Appendix A-1.
(y) “PROFIT
PER UNIT” shall mean, with respect to a PRESENTATION for any
period, the greater of (i) the quotient of (A) the total
of (x) NET SALES for such PRESENTATION, less (y) COST OF
GOODS SOLD for such PRESENTATION sold in the TERRITORY, less
(z) BIOREX ROYALTIES (if any) for such PRESENTATION, in each
case for such period, divided by (B) the actual number of
UNITS of such PRESENTATION sold by SALIX, its AFFILIATES and
licensees in the TERRITORY during such period and (ii) [*]% of
the highest list price per UNIT of such PRESENTATION in the
TERRITORY during such period. For the avoidance of doubt, the
PROFIT PER UNIT will be calculated for each PRESENTATION. For
example the PROFIT PER UNIT for the 750 mg capsule PRESENTATION
will be the greater of (i) above as computed for the 750 mg
capsule PRESENTATION and (ii) [*]% of the highest list price
per UNIT of the 750 mg capsule PRESENTATION for the applicable
period. The PROFIT PER UNIT for the 1100 mg tablet
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
PRESENTATION will be the
greater of (i) above as computed for the 1100 mg tablet
PRESENTATION and (ii) [*]% of the highest list price per UNIT
of the 1100 mg tablet PRESENTATION for the applicable period. An
example of this calculation is provided in Appendix A-1.
Notwithstanding anything herein to the contrary, in the event that
any PRESENTATION is not sold by SALIX, its Affiliates or licensees
during any CONTRACT QUARTER, the PROFIT PER UNIT for such
PRESENTATION for such CONTRACT QUARTER shall be the PROFIT PER UNIT
for such PRESENTATION for the immediately preceding CONTRACT
QUARTER.
(z) “RETAIL
TRx COUNT” shall mean, with respect to any PRESENTATION for
any period, Retail TRx Count for such PRESENTATION for such period
as reported on PHAST as determined in accordance with Appendix
C.
(aa) “RETAIL
TRx QUANTITY” shall mean, with respect to any PRESENTATION
for any period, Retail TRx Qty for such PRESENTATION for such
period as reported on PHAST as determined in accordance with
Appendix C.
(bb) “SAMPLE”
shall mean, with respect to each PRESENTATION, UNITS of such
PRESENTATION which are not intended to be sold or traded, which are
intended to be distributed to authorized healthcare professionals,
and which are intended to promote the sale of such prescription
drug.
(cc) “SWITCHING
DATA” shall mean a single data source to be used to determine
the number of prescriptions switched from the PRODUCT to the
GRANULATED MESALAMINE PRODUCT, and from the GRANULATED MESALAMINE
PRODUCT to the PRODUCT, which shall be mutually selected by the
PARTIES from the following three (3) options: (i) IMS
Health - NPA Market Dynamics, (ii) Verispan - Vector One
(VONA), and (iii) WOLTERS KLUWER Source ® PatientTrends,
Behavior Dynamics - New to Product starts by specialty, Switching
within therapeutic class by specialty.
(dd) “TERRITORY”
shall mean the United States of America, including its territories
and possessions.
(ee) “THIRD
PARTY” shall mean a party other than EISAI or SALIX or their
respective AFFILIATES.
(ff) “TOTAL
PRESCRIPTIONS” shall mean, with respect to any period, the
aggregate amount of CONVERTED PRESCRIPTIONS for all PRESENTATIONS
for such period.
(gg) “TRADEMARK”
shall mean the mark ‘Colazal’ filed with the United
States Patent and Trademark Office and assigned a registration
number of 2534845 and any other trademark applicable to a PRODUCT
during the TERM.
(hh) “UNIT”
shall mean a PRESENTATION in the smallest identifiable form (e.g.,
tablet or capsule for solid dosage forms, milliliter for liquid
forms, gram for inhaled respiratory products, ointments or
creams).
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
(ii) “WOLTERS
KLUWER” shall mean Source Healthcare Analytics,
Inc.
(jj) “WSI
AGREEMENT” shall mean that certain Master Professional
Services Agreement dated March 20, 2007 by and between SALIX
and WSI.
(kk) “WSI”
shall mean WSI PBG, LLC.
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2.1 |
Co-Promoter Arrangement .
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(a) SALIX hereby
appoints EISAI as the exclusive co-promoter of the PRODUCTS to
PHYSICIANS in the TERRITORY beginning on or about October 1,
2007. The actual date of the commencement by EISAI of its
co-promotion activities hereunder (the “START DATE”)
shall be confirmed in writing by the PARTIES. EISAI accepts such
appointment and agrees to DETAIL the PRODUCTS through the SALES
FORCE only to PHYSICIANS in accordance with the terms of this
Agreement. Neither PARTY shall authorize any THIRD PARTY to promote
the PRODUCTS to PHYSICIANS. SALIX represents and warrants to EISAI
that as of the date hereof, no THIRD PARTY is authorized to promote
the PRODUCTS to PHYSICIANS, and SALIX covenants that SALIX will not
grant any rights to a THIRD PARTY to promote the PRODUCTS in the
TERRITORY; provided, however, that EISAI acknowledges and agrees
that SALIX is, and may continue to be, a party to the WSI AGREEMENT
pursuant to which WSI promotes the PRODUCTS in Department of
Veterans Affairs health system facilities (but in no other
facilities). SALIX retains all rights to continue to promote the
PRODUCTS in the TERRITORY through its own employees.
(b) Each of
SALIX and EISAI shall be legally responsible and liable for the
actions, omissions and conduct of all members of its SALES FORCE
and its other employees performing activities hereunder. Each of
SALIX and EISAI shall ensure that all persons for whom it has legal
responsibility and liability in accordance with the foregoing
sentence comply with all APPLICABLE LAWS and all requirements of
this Agreement, and shall implement and maintain policies and
procedures to ensure such compliance; provided that in no event
shall EISAI have any responsibility or liability for the MARKETING
MATERIALS or the use thereof.
(c) During the
period commencing on the START DATE and ending [*], EISAI shall
ensure that no fewer than [*] members of the EISAI SALES FORCE are
performing DETAILS in the TERRITORY on an active basis as
appropriate, taking into account the circumstances of each sales
call to a PHYSICIAN. EISAI shall train all members of the EISAI
SALES FORCE who perform DETAILS using the training materials
provided by SALIX pursuant to Section 2.4(a)(iii) below. From
and after [*], EISAI shall use commercially reasonable efforts, as
determined by EISAI, to DETAIL the PRODUCTS in the
TERRITORY.
(d) During each
CONTRACT QUARTER, SALIX shall (i) maintain in the TERRITORY
[*] employed or contracted professional sales representatives to
comprise the SALIX SALES FORCE, subject to ordinary course turnover
that does not permanently reduce
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
the size of the SALIX SALES
FORCE, and (ii) perform, through the SALIX SALES FORCE, at
least [*] DETAILS.
(e) During
(i) the CONTRACT YEAR that ends December 31, 2007, SALIX
shall expend at least $[*] for the advertising, marketing and
promotion of the PRODUCTS in the TERRITORY, and (ii) each
CONTRACT YEAR thereafter, shall expend at least $[*] for the
advertising, marketing and promotion of the PRODUCTS in the
TERRITORY, in each case which amounts shall be expended in
accordance with an annual SALIX marketing plan (the “SALIX
PLAN”) to be provided by SALIX to the STEERING COMMITTEE. For
the avoidance of doubt, the amounts required to be expended
pursuant to this Section 2.1(e) shall not include any costs
related to the SALIX SALES FORCE but shall include amounts
allocated to EISAI pursuant to Section 2.2(b).
(f) EISAI, not
later than [*] calendar days following the end of each CONTRACT
QUARTER, shall provide to SALIX a report, in electronic form, which
shall contain the following information with respect to such just
ended CONTRACT QUARTER: (i) the number of DETAILS to
PHYSICIANS in the TERRITORY made by EISAI, through the EISAI SALES
FORCE, as recorded by EISAI’s standard record keeping
procedures for details; (ii) the percentage of PHYSICIANS
DETAILED who were provided with SAMPLES of the PRODUCTS; and
(iii) the number of SAMPLES given to PHYSICIANS. Upon
SALIX’s request, EISAI shall provide SALIX with (A) a
master list of all PHYSICIANS to which EISAI provides DETAILS and
(B) the American Medical Association Medical Education number
and state license number of each such PHYSICIAN; provided that
EISAI otherwise possesses such information and has the legal right
to provide it to SALIX.
(g) SALIX, not
later than [*] calendar days following the end of each CONTRACT
QUARTER, shall provide to EISAI a report, in electronic form, which
shall contain the following information with respect to such just
ended CONTRACT QUARTER: (i) the number of DETAILS to
PHYSICIANS in the TERRITORY made by SALIX, through the SALIX SALES
FORCE, as recorded by SALIX’s standard record keeping
procedures for details; (ii) the percentage of PHYSICIANS
DETAILED who were provided with SAMPLES of the PRODUCTS;
(iii) the number of SAMPLES given to PHYSICIANS;
(iv) gross sales of PRODUCTS and all deductions necessary to
calculate NET SALES; (v) COST OF GOODS SOLD for PRODUCTS sold
in the TERRITORY; (vi) BIOREX ROYALTIES by PRESENTATION;
(vii) CONVERTED PRESCRIPTIONS for each PRESENTATION and TOTAL
PRESCRIPTIONS (and supporting PHAST data); (viii) the actual
number of UNITS of each PRESENTATION sold by SALIX, its AFFILIATES
and licensees in the TERRITORY, (ix) the amount payable to
EISAI pursuant to Section 2.5(a) by PRESENTATION; (x) the
amount of advertising, marketing and promotional expenses expended
by SALIX pursuant to Section 2.1(e), (x) AVERAGE UNITS
PER PRESCRIPTION for each PRESENTATION (and supporting PHAST data),
and (xi) any changes or adjustments made by WOLTERS KLUWER in
such CONTRACT QUARTER to PHAST data for PRODUCTS previously
reported by WOLTERS KLUWER. Upon EISAI’s request, SALIX shall
provide EISAI with (A) a master list of all PHYSICIANS to
which SALIX provides DETAILS and (B) the American Medical
Association Medical Education number and state license number of
each such PHYSICIAN;
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
provided that SALIX otherwise
possesses such information and has the legal right to provide it to
EISAI.
(h) Each PARTY
covenants that, in performing its obligations under this Agreement,
it shall (i) at all times comply with any and all APPLICABLE
LAWS and the PhRMA Code on Interactions with Health Care
Professionals ; (ii) at all times perform its obligations
under this Agreement in a professional, ethical and competent
manner; (iii) make only such statements and claims regarding
each PRODUCT, including as to efficacy and safety, as are
consistent with the labeling for such PRODUCT approved by the FDA
at the time such statements are made and the MARKETING MATERIALS;
provided that SALIX may distribute scientific articles and
reference publications concerning the PRODUCTS in accordance with
APPLICABLE LAWS; (iv) not make any untrue or misleading
statements or comments about the PRODUCTS; and (v) not
disparage or present in a negative light the PRODUCT, the
TRADEMARKS and/or the other PARTY; provided that in no event shall
EISAI have any responsibility or liability for the MARKETING
MATERIALS or the use thereof.
(i) Each PARTY
shall promote the PRODUCTS only under the applicable TRADEMARK and
shall not use any other trademark(s) in the promotion of the
PRODUCTS (other than any other trademark of SALIX or its licensors
included in the MARKETING MATERIALS and, in the case of EISAI, the
corporate name and logos of EISAI). SALIX hereby grants to EISAI a
nontransferable, royalty-free, non-exclusive license (without the
right to sublicense) to use the TRADEMARKS (and any other trademark
of SALIX or its licensors included in the MARKETING MATERIALS) and
the MARKETING MATERIALS solely for purposes of performing its
obligations hereunder.
(j) EISAI shall
develop a strategy for the DETAILING of the PRODUCTS to PHYSICIANS
by the EISAI SALES FORCE hereunder which shall be set forth in an
annual promotional plan (the “SALES PLAN”). Prior to
the implementation of any SALES PLAN (or any material amendment to
a SALES PLAN), SALIX shall be provided with a reasonable
opportunity, through the STEERING COMMITTEE to provide input into
such SALES PLAN or amendment and EISAI shall give good faith
consideration to any comments of SALIX thereon.
(k) SALIX shall
be responsible, in its sole discretion, for developing and
producing all sales, promotional, advertising and/or similar
materials (the “MARKETING MATERIALS”) for the PRODUCTS;
provided that SALIX shall provide to EISAI drafts of all MARKETING
MATERIALS developed by SALIX after the date hereof at least [*]
days in advance of the date of final approval of such materials by
SALIX, and SALIX shall give good faith consideration to any
comments thereon provided by EISAI within [*] days after receipt of
any such draft. SALIX represents, warrants and covenants that all
MARKETING MATERIALS will comply with all APPLICABLE LAWS and will
not contain any untrue or misleading statement or comment about the
PRODUCTS. Neither PARTY shall use any materials in connection with
the marketing and promotion of the PRODUCTS other than the
MARKETING MATERIALS. Each PARTY shall ensure that the MARKETING
MATERIALS are used only in the form provided and not changed in any
way (including by underlining or otherwise highlighting any text or
graphics or adding any notes thereto). Subject to
Section 2.2(b) and Section 2.3(a), SALIX [*] shall
promptly deliver, no more than [*] per CONTRACT [*], to
[*]
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
in the continental United
States as may be directed by EISAI, the amount of MARKETING
MATERIALS requested by EISAI from time to time.
(l) Each PARTY
shall obtain and at all times maintain in full force and effect all
necessary licenses, permits and other authorizations or approvals,
as required by all APPLICABLE LAWS as may be necessary to perform
its duties and obligations as set forth in this
Agreement.
(m) Each PARTY
shall have in effect a commercially reasonable, as determined by
such PARTY, bonus incentive plan for its SALES FORCE designed to
reward sales of the PRODUCTS.
(n) Subject to
Section 2.2(b) and Section 2.3(b), SALIX [*] shall
promptly deliver, no more than [*] per CONTRACT [*], to [*] in the
continental United States as may be directed by EISAI, the number
of SAMPLES requested from time to time by EISAI. The PARTIES
acknowledge and agree that such SAMPLES shall be provided by EISAI
to PHYSICIANS free of charge in connection with EISAI’s
promotion of the PRODUCTS. EISAI shall at all times ensure that its
PRODUCT SAMPLE program complies will all APPLICABLE LAWS, including
the Prescription Drug Marketing Act.
(o) If EISAI
believes that (i) the use of any MARKETING MATERIALS or
(ii) compliance with the training materials provided pursuant
to Section 2.4(a)(iii), in each case might potentially violate
any APPLICABLE LAWS or EISAI’s ethical business practices and
policies, EISAI promptly shall notify SALIX of such belief and the
PARTIES promptly shall engage in good faith discussions through
their respective legal departments to attempt to resolve such
situation. Notwithstanding anything to the contrary in this
Agreement, EISAI shall not be required to take, and shall not be
penalized for not taking, any action that is not in compliance with
EISAI’s ethical business practices and policies or that EISAI
reasonably believes is not in compliance with APPLICABLE
LAWS.
(p) During the
TERM and for a period of [*] thereafter, neither PARTY shall
actively recruit or solicit any member of the other PARTY’s
SALES FORCE or any other staff of the other PARTY engaged in the
marketing, promotion or DETAILING of the PRODUCTS. For the
avoidance of doubt, nothing shall limit a PARTY from engaging in
general recruitment through advertisements or recruiting through
“head-hunters” so long as the staff of the other PARTY
is not specifically targeted in such recruitment effort.
2.2 Sales
Steering Committee . SALIX and EISAI shall form a Sales
Steering Committee (the “STEERING COMMITTEE”) which
shall be comprised of four (4) representatives of each PARTY.
The STEERING COMMITTEE shall have the responsibilities set forth
below in this Section 2.2 and, in addition, shall review the
SALES PLANS and the SALIX PLANS and provide a forum for the PARTIES
to discuss the co-promotion of the PRODUCTS in the TERRITORY and
issues related thereto.
(a) The STEERING
COMMITTEE shall meet at least two (2) times per CONTRACT YEAR,
with a least one (1) of such meetings being in-person and with
the location of such in-person meetings alternating between
locations designated by EISAI and locations
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
designated by SALIX, with
SALIX designating the first such meeting. Each PARTY shall bear its
own expenses in connection with attending such meetings.
(b) The STEERING
COMMITTEE shall consider and recommend to SALIX in good faith
(i) the quantity of MARKETING MATERIALS to be used in
connection with DETAILING each CONTRACT YEAR and the allocation
thereof between the PARTIES and (ii) the quantity of SAMPLES
to be distributed in connection with DETAILING in such CONTRACT
YEAR and the allocation thereof between the PARTIES, in each case
taking into account the respective DETAILING efforts to be provided
by the PARTIES; provided that SALIX shall provide to EISAI, without
cost to EISAI, no less than an aggregate quantity of MARKETING
MATERIALS and SAMPLES, in such allocations as shall be determined
by EISAI from time to time, for use by EISAI in DETAILING during
each CONTRACT YEAR with a value (determined in accordance with
Section 2.3) of (i) $[*] for the CONTRACT YEAR ending
December 31, 2007, (ii) $[*] for the CONTRACT YEAR ending
December 31, 2008; (iii) $[*] for the CONTRACT YEAR
ending December 31, 2009, and (iii) $[*] for each
CONTRACT YEAR thereafter.
2.3
Additional Materials .
(a) In the event
that EISAI desires MARKETING MATERIALS in excess of its allocation
pursuant to Section 2.2(b), SALIX shall sell all such
materials EISAI desires to EISAI at SALIX’s actual cost for
such materials.
(b) In the event
that EISAI desires SAMPLES in excess of its allocation pursuant to
Section 2.2(b), SALIX shall sell such SAMPLES to EISAI at the
COST OF GOODS SOLD for such SAMPLES, provided, however, SALIX shall
be permitted to reasonably limit the number of SAMPLES sold to
EISAI.
(c) EISAI shall
purchase an aggregate quantity of additional MARKETING MATERIALS
and SAMPLES, in such allocations as shall be determined by EISAI
from time to time, for use by EISAI in DETAILING with a value
(determined in accordance with this Section 2.3) of no less
than (i) $[*] for the CONTRACT YEAR ending December 31,
2008 and (ii) $[*] for the CONTRACT YEAR ending
December 31, 2009.
(d) SALIX
promptly shall invoice EISAI for all SAMPLES and MARKETING
MATERIALS sold pursuant to this Section 2.3, and EISAI shall
pay each such invoice within [*] days after receipt
thereof.
2.4 Sale,
Manufacture and Regulatory Maintenance of the PRODUCTS
.
(a) SALIX shall
have the sole right and obligation to:
(i) Manufacture
(or having manufactured by its licensees, vendors or
AFFILIATES), package, label, ship, warehouse and distribute the
PRODUCTS in the TERRITORY; provided, however, that SALIX shall
maintain supply chain standards with redundant systems
consistent with those in effect during the twelve
(12) months preceding the date of this
Agreement;
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
(ii) Accept
orders, invoice customers and collect receivables resulting from
sales of the PRODUCTS in the TERRITORY;
(iii) Provide
to EISAI, at [*] expense, the PRODUCT training materials and
services described on Appendix D;
(iv) Provide
customer service activities and medical information services
(including response to medical inquiries);
(v) Obtain
and maintain all FDA and other regulatory or governmental
approvals necessary to manufacture, market, promote, sell and
distribute the PRODUCTS in the TERRITORY at all times during the
TERM;
(vi) prepare,
submit and prosecute all applications, reports, submissions and
responses to the FDA and other governmental agencies in
connection with the PRODUCTS, including reporting adverse drug
experiences and field alerts;
(vii) Maintain
the TRADEMARK registrations in good standing, defend any
TRADEMARK challenge and use commercially reasonable efforts to
prosecute any TRADEMARK infringement;
(viii) Respond
to all medical inquiries relating to the PRODUCTS;
and
(ix) Subject
to clause (d) below, engage in all activities related to
managed care (including contracting) concerning the
PRODUCTS.
(b) Any PRODUCT
returned to EISAI shall be shipped by EISAI to SALIX, or its
designee’s nearest facility, at SALIX’s
expense.
(c) All sales of
the PRODUCTS in the TERRITORY shall be invoiced by
SALIX.
(d) All terms of
sale, including policies concerning pricing, credit terms, cash
discounts and returns and allowances shall be set by SALIX
consistent with SALIX’s internal selling practices; provided,
however, that the foregoing shall not permit SALIX to set any
pricing terms with respect to SAMPLES sold to EISAI which are
inconsistent with the terms of this Agreement.
(e) All customer
orders for the PRODUCTS shall be received and executed by SALIX or
its designee. If EISAI receives any such orders it shall refer such
to SALIX.
(f) Each PARTY
shall promptly notify the other PARTY of any and all governmental
notices, actions, inquiries or requests for information relating to
the PRODUCTS (including any warning letters). SALIX shall have the
sole authority to, and shall, handle all governmental notices,
actions, inquiries or requests for information about the PRODUCTS
and EISAI shall, upon the reasonable request of SALIX and at
SALIX’s expense, provide SALIX with assistance in responding
to any such governmental notices, actions, inquiries or requests
for
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
information; provided that
EISAI may respond to any notice, action, inquiry or request for
information from a governmental authority relating to the PRODUCTS
or its performance of this Agreement which response, in the
reasonable opinion of EISAI’s counsel, is required by law.
EISAI shall, to the extent reasonably practicable, provide SALIX
notice of such inquiry and consider in good faith any comments of
SALIX with respect thereto prior to making such
response.
(g) Not later
than sixty (60) days after the date of execution of this
Agreement, the PARTIES shall enter into a Safety Data Exchange
Agreement with respect to the PRODUCTS containing reasonable and
customary terms and conditions. Prior to the date of execution of
such Agreement, EISAI shall forward any adverse event reports or
complaint reports with respect to the PRODUCTS to SALIX in time for
SALIX to comply with regulatory reporting requirements in the
TERRITORY.
(h) EISAI shall
refer all medical information requests to SALIX and shall provide
assistance as reasonably requested by SALIX at SALIX’s
expense in responding to such requests.
(i) SALIX shall
manufacture the PRODUCTS (including SAMPLES) or cause such
manufacture in conformance with all APPLICABLE LAWS (including the
Federal Food Drug and Cosmetic Act (“FD&C ACT”))
and the rules and regulations thereunder, including current Good
Manufacturing Practices). SALIX warrants that at the time of
delivery of all PRODUCT to a THIRD PARTY, such PRODUCT
(i) will comply with the specifications therefor set forth in
the New Drug Application for such PRODUCT approved by the FDA,
(b) will have been manufactured in material compliance with
all APPLICABLE LAWS, (c) will not be adulterated or misbranded
within the meaning of the FD&C ACT, and (d) may be
introduced into interstate commerce pursuant to the FD&C
ACT.
(j) SALIX shall
furnish and make available, as reasonably requested by EISAI from
time to time, all readily available information on the efficacy,
clinical development and regulatory status of the
PRODUCTS.
(k) SALIX shall
duly and punctually perform all of its obligations under and
pursuant to the BIOREX AGREEMENT. SALIX promptly shall provide to
EISAI each amendment or modification to the BIOREX
AGREEMENT.
(l) SALIX shall
perform all of its obligations under this Section 2.4 in
accordance with all APPLICABLE LAWS and the PhRMA Code on
Interactions with Health Care Professionals .
2.5
Payment .
(a) Within [*]
days after the end of each CONTRACT QUARTER during the TERM, SALIX
shall pay to EISAI an amount with respect to each PRESENTATION for
such CONTRACT QUARTER equal to (i) [*] percent ([*]%),
multiplied by (ii) the PROFIT PER PRESCRIPTION for such
PRESENTATION for such CONTRACT QUARTER, multiplied by
(iii) the positive difference, if any, between
(A) CONVERTED PRESCRIPTIONS for such
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
PRESENTATION in the TERRITORY
for such CONTRACT QUARTER, less (B) the product of
(1) the BASELINE CONVERTED PRESCRIPTIONS for such CONTRACT
QUARTER, multiplied by (2) the PRESENTATION RATIO for such
PRESENTATION for such CONTRACT QUARTER. An example of this
calculation is set forth in Appendix A-2.
(b) Reduction of
BASELINE CONVERTED PRESCRIPTIONS.
(i) For any
partial CONTRACT QUARTER (less than three (3) full months)
during the TERM, the BASELINE CONVERTED PRESCRIPTIONS for such
CONTRACT QUARTER shall be reduced by a percentage equal to
[*].
(ii) Within
[*] days after the end of each month during the TERM, SALIX
shall deliver to EISAI a report of [*], during such month. If
EISAI reasonably believes that any such report indicates that
[*], EISAI may, at any time in the then current CONTRACT QUARTER
or the following CONTRACT QUARTER, request that SALIX [*]. [*],
then the BASELINE CONVERTED PRESCRIPTIONS for such CONTRACT
QUARTER shall be reduced by a percentage equal to
[*].
(iii) In the
event that in a CONTRACT QUARTER SALIX fails to perform the
number of DETAILS required pursuant to Section 2.1(d), then
the BASELINE CONVERTED PRESCRIPTIONS for such CONTRACT QUARTER
shall be reduced by a percentage equal to [*].
(iv) In the
event that in a CONTRACT YEAR SALIX fails to expend the amount
of advertising, marketing and promotional expense for the
PRODUCTS required pursuant to Section 2.1(e), then
(A) the BASELINE CONVERTED PRESCRIPTIONS for each CONTRACT
QUARTER in such CONTRACT YEAR shall be reduced by a percentage
equal to [*] and (B) [*].
(v) In the
event that, as of the date of first sale of the GRANULATED
MESALAMINE PRODUCT in the TERRITORY, EISAI is not promoting the
GRANULATED MESALAMINE PRODUCT in the TERRITORY, the BASELINE
CONVERTED PRESCRIPTIONS for each CONTRACT QUARTER shall be
reduced by an amount equal to [*]. For example, [*].
(vi) If, at
any time during the TERM, WOLTERS KLUWER changes the methodology
used to determine prescriptions for the PRODUCTS from that used
by WOLTERS KLUWER on the date hereof (or if another source for
determining prescriptions of the PRODUCTS is agreed to by the
PARTIES), then the BASELINE CONVERTED PRESCRIPTIONS for each
CONTRACT QUARTER after such change in methodology shall be
adjusted to reflect such change in methodology such that the
adjusted BASELINE CONVERTED PRESCRIPTIONS for future CONTRACT
QUARTERS are set in a manner commensurate with the original
BASELINE CONVERTED PRESCRIPTIONS as measured against the
historical WOLTERS KLUWER data used to derive the original
BASELINE CONVERTED PRESCRIPTIONS.
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
(vii) For the
avoidance of doubt, the provisions of this Section 2.5(b)
are cumulative and the BASELINE CONVERTED PRESCRIPTIONS may be
reduced any number of times with respect to any CONTRACT QUARTER
hereunder. If more than one (1) reduction under this
Section 2.5(b) applies to any CONTRACT QUARTER, such
reductions shall be applied so as to achieve the lowest BASELINE
CONVERTED PRESCRIPTIONS possible for such CONTRACT
QUARTER.
(c) In the event
that WOLTERS KLUWER reports any changes or adjustments to any PHAST
data with respect to any PRESENTATION previously reported by
WOLTERS KLUWER (other than changes or adjustments resulting from a
change in methodology as described in Section 2.5(b)(vi)), and
such changed data (as adjusted in accordance with the procedures
set forth on Appendix C) results in any inaccuracy in any amount
previously paid by SALIX pursuant to Section 2.5(a), then the
appropriate PARTY shall within [*] days of such determination pay
to the other PARTY the amount necessary to correct such payment
inaccuracy.
(d) All sums due
under this Agreement shall be payable in U.S. Dollars by federal
funds wire transfer or by check as instructed in writing by the
PARTY to receive such payment from time to time. Any payments or
portions thereof due hereunder that are not paid on the date such
payments are due under this Agreement shall bear interest at a rate
equal to the lesser of the [*] as published by Citibank, N.A., New
York, New York, or any successor thereto, at 12:01 a.m. on the
first day of each CONTRACT QUARTER in which such payments are
overdue, plus [*] percentage points, and the maximum rate permitted
by applicable law, calculated on the number of days such payment is
delinquent, compounded monthly.
2.6 Each PARTY
shall keep complete and accurate records (financial and otherwise)
pertaining to the performance of its obligations hereunder in
sufficient detail to calculate accurately all amounts payable
pursuant to this Agreement and to prepare all reports required
hereunder, including, with respect to SALIX, records of gross sales
of the PRODUCTS in the TERRITORY and all information necessary to
determine NET SALES, COST OF GOODS SOLD, and BIOREX ROYALTIES. Such
records (and all related work papers and other information and
documents) shall be retained and made available for reasonable
review by the other PARTY upon reasonable notice, during normal
business hours, no more than once each CONTRACT YEAR and in the
twelve (12)-month period following expiration or termination of
this Agreement for the purposes of verifying compliance with this
Agreement and the accuracy of all reports delivered and payments
made hereunder. Each document from which the reports and statements
are prepared pursuant to this Agreement shall be retained for three
(3) years, and the right of inspection hereunder shall
terminate with respect thereto at the end of such three
(3) year period.
2.7 SALIX shall
promptly notify EISAI in writing of any facts relating to the
advisability of a recall, destruction, withholding from the market,
market withdrawal or other similar market action relating to any
PRODUCT (collectively, “RECALL(s)”). If at any time:
(i) any governmental or regulatory authority issues a request,
directive or order for a RECALL; (ii) a court of competent
jurisdiction orders a RECALL; or (iii) SALIX determines,
following
[*] Confidential
treatment requested; certain information omitted and filed
separately with the SEC.
consultation with EISAI
(except in emergency situations in which there is insufficient time
for such consultation), that a RECALL is necessary or advisable,
SALIX shall take all appropriate actions to effect the RECALL.
EISAI shall provide SALIX with cooperation in connection with any
RECALL as reasonably requested SALIX. SALIX shall bear all of the
costs of any RECALL (including EISAI’s reasonable costs
incurred in cooperating therewith) except to the extent that such
RECALL results from a breach of this Agreement by EISAI, in which
event EISAI shall bear the c
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