Exhibit 10.1
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*Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
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CO-PROMOTION
AGREEMENT
THIS CO-PROMOTION AGREEMENT
(this “Agreement”) is
dated and effective as of the
day of January, 2005 (the “Effective Date”).
BY AND BETWEEN
SOLVAY PHARMACEUTICALS, INC.,
on behalf of UNIMED
PHARMACEUTICALS, INC . its wholly owned subsidiary, a Delaware
corporation, maintaining a place of business at 901 Sawyer Road,
Marietta, Georgia 30062 (hereinafter,
“SOLVAY”),
AND:
ICOS Technology Services, LLC
, a Delaware limited liability
corporation, maintaining a place of business at 4948 West
145 th Street, Midlothian, Illinois 60445,
a wholly-owned subsidiary of ICOS Corporation, a Delaware
Corporation (hereinafter, “ICOS”).
RECITALS:
WHEREAS SOLVAY markets AndroGel ® (testosterone gel) 1%, a proprietary
pharmaceutical product comprising testosterone in a gel
formulation, and
WHEREAS ICOS desires to co-promote AndroGel
®
with SOLVAY in the United States,
in accordance with the terms and conditions of this
Agreement.
NOW, THEREFORE , in consideration of the mutual covenants
herein set forth, and intending to be legally bound hereby, the
Parties hereto agree as follows:
ARTICLE 1
INTERPRETATION
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1.
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Definitions . In this Agreement, the following terms shall
have the following meanings, except where the context otherwise
requires:
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1.1
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“
Affiliate ” means any corporation or business
entity of which a party owns, directly or indirectly, fifty percent
(50%) or more of the assets or outstanding stock or other ownership
interests, or any corporation or business entity which a party
directly or indirectly controls, or any parent corporation or
business entity that owns, directly or indirectly, fifty percent
(50%) or more of the assets or outstanding stock or ownership
interests of a party or which directly or indirectly controls a
party.
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1.2
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“ [*]
Position Detail ” means a presentation of the
Product to a licensed prescriber by a Representative in which the
Product [*] .
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1.3
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“
Frequency Goal ” shall mean the number of Sales Calls that ICOS
is obligated to make in a particular Sales Quarter, as set forth in
Section 2.2(a) below.
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1.4
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“GAAP” means generally accepted accounting principles
in the United States.
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*Confidential Treatment
Requested.
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1.5
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“
Gross Margin ” means Net Sales less [*] percent (
[*] %) of SOLVAY’s Manufacturing Cost for the Product,
as calculated in accordance with GAAP. Manufacturing Cost for the
Product shall be the sum of:
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(i) the cost of goods produced,
including without limitation direct labor and material costs and
product quality assurance/quality control costs, as well as
overhead properly allocated to manufacturing of the Product;
[*] ;
(ii) all revenue-based royalties
paid to Third Parties under patent or technology licenses that are
necessary in order to manufacture, use, sell, or distribute the
Product;
(iii) [*] and other services
rendered pursuant to [*] .
Notwithstanding the foregoing, in
the event that the calculation of Manufacturing Cost in accordance
with subsections (i) through (iii) above exceeds [*] percent
( [*] %) of Net Sales, then Manufacturing Cost shall be
deemed to be [*] percent ( [*] %) of Net
Sales.
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1.6
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“
Gross Sales” means the gross amount invoiced by SOLVAY, its
Affiliates, sublicensees, or other agents for sales of the Product
to Third Parties in the Territory, as calculated in accordance with
GAAP.
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1.7
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“
Net Sales ” means Gross Sales less the following, all as
calculated in accordance with GAAP:
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(i) normal or customary trade, cash,
and quantity discounts on the Product (other than price discounts
granted at the time of invoicing and which are included in the
determination of Gross Sales); and
(ii) Credits or allowances made for
rejection or return of previously sold Product or for retroactive
price adjustments (including chargebacks and Medicaid and similar
types of rebates);
plus , any retroactive price increases or other
positive adjustments (e.g., credits based on true-up of estimated
rebate payments).
Net Sales will be adjusted for
fluctuations in wholesaler [*] inventory levels during the
term of this Agreement. For the sake of clarity, the intent of this
adjustment is to align Net Sales with prescription demand for the
Product. The change in wholesaler inventory levels for the Product
(in units) over the term of this Agreement will be the determinant
for this adjustment. Beginning inventory at the wholesaler level
shall be established as of the 1 st day of January, 2005 and as of the
first day of each Sales Quarter thereafter. [*] The adjusted
Net Sales number will be used to determine the Incremental Fee
compensation to ICOS for the applicable period pursuant to section
3.1. Inventory levels will be documented using [*]
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1.8
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“
Primary Care Target Audience ” means (a)
general practitioners, (b) family practitioners, (c) primary care
physicians and (d) nurse practitioners or other healthcare
professionals under physician supervision with the legal authority
to prescribe the Product.
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1.9
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“
Product ” means AndroGel
®
(testosterone gel) 1%, a proprietary
pharmaceutical product comprising testosterone in a gel formulation
that is currently marketed by SOLVAY in the United States, in all
of its dosage forms and methods of administration, and including
any line extensions, Product substitutes and improvements thereto
and new dosage forms.
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1.10
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“
Representative ” means a sales employee of
SOLVAY or ICOS, as the case may be, who engages in the detailing of
healthcare professionals; in the case of ICOS, Representative means
a member of ICOS’ existing sales force consisting of
approximately 165 persons.
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1.11
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“
Sales Call ” means a presentation to a member
of the Target Audience by a Representative during which such
Representative promotes the Product.
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*Confidential Treatment
Requested.
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1.12
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“
Sales Quarter ” shall mean a period of three
(3) consecutive calendar months ending March 31, June 30, Sept. 30
and December 31, during the term of this Agreement during which
ICOS Sales Representatives make Sales Calls relating to the
Product.
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1.13
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“ [*]
Position Detail ” means a presentation of the
Product to a licensed prescriber by a Representative in which the
Product [*] .
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1.14
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“
Specialty Target Audience ” means
endocrinologists, urologists, HIV and infectious disease physicians
or other specialists who may prescribe the Product for its labeled
indication, and other healthcare professionals under the
supervision of such specialists with the legal authority to
prescribe the Product.
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1.15
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“
Target Audience ” means [*] .
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1.16
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“
Territory ” means the United States,
exclusive of Alaska, Hawaii, Puerto Rico, and the other territories
and possessions of the United States.
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1.17
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“Third Party”
means any entity or individual other
than SOLVAY or ICOS or their respective Affiliates.
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ARTICLE 2
OBLIGATIONS OF
ICOS
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2.1
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Appointment to Co-Promote
. SOLVAY hereby appoints ICOS, and
ICOS hereby accepts appointment, to promote the Product in
conjunction with SOLVAY in the Territory for the term of this
Agreement, in accordance with the terms and conditions of this
Agreement. Each party agrees to cooperate and act in good faith
with the other party in the performance of this Agreement and to
provide reasonable support to the other party in the performance of
such other party’s obligations hereunder. ICOS shall not have
the right to sublicense, assign, or subcontract its rights or
obligations hereunder, except in accordance with Section 14.11
below. In consideration for such appointment, ICOS agrees not to
engage in the promotion or marketing of products competitive with
the Product within the Territory during the term of this Agreement
and for a period of [*] ( [*] ) months after its
expiration, provided, however, that this prohibition shall not
apply in the event that this Agreement is terminated (a) by ICOS
pursuant to Section 8.2(iii), 8.2(iv), or 8.2(v), below, or (b) by
SOLVAY pursuant to Section 8.2(iii), or Section 8.3(ii) below. For
purposes of this provision, a product shall be deemed to be
competitive with the Product if it is approved by the U.S. Food and
Drug Administration (“FDA”) with an indication in the
product prescribing information for the treatment of [*]
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2.2
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Scope of
Co-Promotion Activities . ICOS Representatives shall perform Sales Calls
on the Target Audience as follows:
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(a)
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Except as
otherwise set forth herein, ICOS Representatives shall perform the
number of Sales Calls required to meet the Frequency Goal for each
Sales Quarter. Beginning with the second Sales Quarter, the
Frequency Goal for ICOS Representatives shall be [*] Sales
Calls per Sales Quarter. For the first Sales Quarter, the Frequency
Goal for ICOS Representatives shall be determined proportionally as
follows:
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(i) A fraction (the
“Adjustment Factor”) shall be created, the numerator of
which will be the number of complete calendar weeks in the first
Sales Quarter during which ICOS Sales Representatives conduct Sales
Calls and the denominator of which shall be thirteen
(13);
(ii) The Adjustment Factor shall be
multiplied by [*] ; and
(iii) The resulting number shall be
the Frequency Goal for the first Sales Quarter.
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(b)
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All Sales Calls
by ICOS Representatives shall be performed in the [*]
Position Detail or [*] Position Detail, to the Target
Audience.
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*Confidential Treatment
Requested.
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(c)
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Notwithstanding
the foregoing, ICOS shall not be deemed to have failed to reach its
Frequency Goal in a particular Sales Quarter if at least one (1) of
the following is true:
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(i) the number of Sales Calls
performed by ICOS (the “Actual Sales Calls”) for such
Sales Quarter is at least [*] percent ( [*] %) of the
Frequency Goal for such Sales Quarter, and/or
(ii) the Average Sales Calls for
such Sales Quarter is at least [*] percent ( [*] %)
of the Frequency Goal for such Sales Quarter. For purposes of this
Section 2.2(c)(ii), the “Average Sales Calls” for a
Sales Quarter shall be determined by averaging the number of Actual
Sales Calls during such Sales Quarter with [*] .
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(d)
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ICOS
Representatives shall during Sales Calls utilize promotional
materials supplied by SOLVAY pursuant to Section 4.5 to the Target
Audience, as reasonably appropriate. ICOS shall not distribute any
other Product promotional materials unless approved in advance by
SOLVAY in writing.
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(e)
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ICOS shall use
its best efforts to launch the Sales Calls by the ICOS
Representatives as soon as possible and in no event later than the
week of [*] or [*] weeks after execution of this
Agreement, whichever is later.
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2.3
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Representations to Customers
. ICOS covenants that its
Representatives will not make any false or misleading
representations to customers regarding the Product and will not
make any representations, warranties or guarantees with respect to
the specifications, features or capabilities of the Product that
are not consistent with any of the applicable and then current FDA
approved labeling, package insert, Product promotional materials
provided by SOLVAY, or other documentation accompanying or
describing the Product that has been provided to ICOS by
SOLVAY.
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2.4
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Training
of ICOS Representatives . ICOS will provide training on the Product
during ICOS sales training classes to be held as soon as reasonably
practicable following execution of this Agreement. SOLVAY will be
responsible for providing all Product-specific sales training
materials and for ensuring that their content is consistent with
applicable legal and regulatory standards. ICOS shall have the
opportunity to review all training materials prior to using them to
train ICOS Representatives. Training may be conducted either by
training professionals from SOLVAY or ICOS. ICOS will allocate
appropriate time for ongoing training on the Product at ICOS
national or district sales force meetings. If new developments in
the market require additional training, ICOS may train jointly with
SOLVAY representatives, as agreed upon by the parties. ICOS sales
management and sales training managers will provide periodic
guidance in support of Sales Calls as they deem appropriate. ICOS
will fund all sales training efforts necessary to properly train
its Representatives, with Product technical support from SOLVAY as
required pursuant to Section 4.6 hereof.
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2.5
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ICOS
Programs . ICOS
agrees to evaluate, [*] . ICOS also agrees to review
[*] .
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2.6
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Supervision . ICOS shall provide the necessary ICOS
management and supervisory personnel to coordinate and support the
activities of the ICOS Representatives as appropriate to accomplish
ICOS’s responsibilities under this Agreement. ICOS shall
respond to reasonable SOLVAY requests for information with respect
to [*] .
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2.7
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Incentive
Compensation to Representatives . ICOS will make available to its
Representatives detailing AndroGel ® an incentive compensation plan in which the
target weighting attributed to the promotion of the Product is at
least [*] % of the overall plan. ICOS will not utilize its
existing 165-person sales force to promote a third product (in
addition to Cialis and AndroGel ® ) during [*] ; if ICOS enters into an
agreement to promote a third product during the term of this
Agreement (beginning [*] or later), such product will be
assigned [*] , and ICOS will negotiate in good faith with
Solvay regarding the weighting to be assigned to AndroGel
®
(provided that it shall be at least
[*] %) under its overall incentive compensation plan, in an
effort to ensure that AndroGel ® receives an appropriate amount of attention.
ICOS will provide [*] , and that information shall be
considered ICOS’s Confidential Information subject to Article
12 below.
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*Confidential Treatment
Requested.
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2.8
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Reports . Within thirty (30) days following the end of
each month, ICOS will provide SOLVAY a report regarding Sales Calls
made by ICOS Representatives during such month. The parties shall
agree on the format for such reports and the information to be
included, which may include the number of calls on the Target
Audience, Sales Calls achieved, sample voucher Sales Calls, and
reach and frequency of Sales Calls.
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2.9
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ICOS
Resources . ICOS
sales management personnel will work with the marketing and sales
force leadership of SOLVAY to coordinate field activity, with brand
strategy and tactics relating to the Product established by SOLVAY
with input from ICOS through its participation on the Commercial
Committee. ICOS will designate one or more management personnel
with responsibility for assisting in implementation of Product
promotional programs agreed upon by the Commercial Committee. ICOS
sales management will participate in periodic meetings with SOLVAY,
as agreed upon by the parties, to discuss resource allocation
(e.g., call activity) as well as customer and competition activity
in the shared territories.
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ARTICLE 3
CONSIDERATION
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3.1
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Compensation to ICOS . In consideration of ICOS’s services
under this Agreement, SOLVAY shall compensate ICOS quarterly based
on a fixed promotional payment per Sales Call of $ [*] (the
“Base Fee”), capped at [*] ( [*] ) Sales
Calls per year. If Net Sales exceed [*] U.S. dollars (U.S. $
[*] ) for calendar year 2005, the Base Fee will be increased
to $ [*] beginning January 1, 2006. In addition to the Base
Fee, SOLVAY shall also compensate ICOS quarterly based on
incremental Gross Margin as provided in Subsections (a) through (e)
below (the “Incremental Fee”). The Incremental Fee
shall be calculated as follows:
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(a)
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For the period
from January 1 through December 31, 2005, SOLVAY shall pay ICOS an
Incremental Fee equal to:
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(i)
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[*] percent ( [*] %) of the Gross Margin
associated with Net Sales less than [*] U.S. dollars (US $
[*] );
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(ii)
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[*] percent ( [*] %) of the Gross Margin
associated with Net Sales equal to or greater than [*] U.S.
dollars (US $ [*] ) and less than or equal to [*]
U.S. dollars (U.S. $ [*] );
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(iii)
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[*] percent ( [*] %) of the Gross Margin
associated with Net Sales equal to or greater than [*] U.S.
dollars (U.S. $ [*] ) and less than or equal to [*]
U.S. dollars (U.S. $ [*] ); and
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(iv)
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[*] percent ( [*] %) of the Gross Margin
associated with Net Sales in excess of [*] U.S. dollars
(U.S. $ [*] ).
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(b)
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For the period
from January 1, 2006 through December 31, 2006, SOLVAY shall pay
ICOS an Incremental Fee equal to:
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(i)
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[*] percent ( [*] %) of the Gross Margin
associated with Net Sales less than [*] U.S. dollars (US $
[*] );
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(ii)
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[*] percent ( [*] %) of the Gross Margin
associated with Net Sales equal to or greater than [*] U.S.
dollars (US $ [*] ) and less than or equal to [*]
U.S. dollars (U.S. $ [*] ); and
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(iii)
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[*] percent ( [*] %) of the Gross Margin
associated with Net in excess of [*] U.S. dollars (U.S. $
[*] ).
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*Confidential Treatment
Requested.
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(c)
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For the period
from January 1, 2007 through December 31, 2007 (if the term of this
Agreement is so extended by the parties), SOLVAY shall pay ICOS an
Incremental Fee based on [*] .
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(d)
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For each of
subsections (a) and (b) above, the percentages stated represent
marginal rates, so that each percentage applies only with respect
to the Gross Margin on Net Sales within the corresponding
tier.
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(e)
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Except as set
forth herein, SOLVAY shall, within [*] days after the last
day of each Sales Quarter, make payments to ICOS of amounts due
hereunder, as set forth below, by wire transfer of immediately
available funds to an account designated by ICOS.
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(i) SOLVAY shall pay ICOS for the
number of Sales Calls performed by ICOS during such Sales Quarter,
as reported by ICOS pursuant to Section 2.9 above, based on the
Base Fee; and
(ii) SOLVAY shall make a payment to
ICOS of the estimated Incremental Fee based on the Gross Margin of
Product sold during such Sales Quarter, as further described
herein. In determining the quarterly estimated Incremental Fee
payments, the following “Quarterly Thresholds” for Net
Sales shall be used:
2005: [*] U.S. dollars (U.S.
$ [*] )
2006: [*] U.S. dollars (U.S.
$ [*] )
2007 (if the term of this Agreement
is so extended by the parties): Quarterly Threshold to be agreed
upon by the parties)
For the first three (3) Sales
Quarters in 2005, SOLVAY shall pay ICOS [*] percent (
[*] %) of the Gross Margin on Net Sales in excess of the
applicable Quarterly Threshold. For the first three (3) Sales
Quarters in 2006, SOLVAY shall pay ICOS [*] percent (
[*] %) of the Gross Margin on Net Sales in excess of the
applicable Quarterly Threshold. Following the fourth Sales Quarter
of each calendar year, SOLVAY shall determine the total Net Sales
and Gross Margin for the Product for such calendar year and shall
perform a true-up calculation to determine the additional amounts
owed by one party to the other for such calendar year, so that ICOS
receives the actual Incremental Fee compensation that it is due for
such calendar year under subsections (a), (b), and (c) above.
SOLVAY shall submit such true-up calculation to ICOS within
[*] days following the end of the applicable calendar year,
and the party owing amounts to the other shall pay such amounts
within [*] days following the end of the calendar year.
Notwithstanding the foregoing, if ICOS objects in writing to
SOLVAY’s calculation of amounts due for the calendar year,
ICOS shall promptly notify SOLVAY and the parties shall immediately
collaborate in good faith to determine and pay the appropriate
amounts due, provided, however, that ICOS’s failure to object
to any such calculation shall not limit its ability to audit SOLVAY
under Section 5.1 below or otherwise act as a waiver of any rights
or remedies that ICOS may have hereunder.
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(f)
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Illustration
of final Incremental Fee calculation : Assume that total Net Sales for the period
from January 1 through December 31, 2005, are [*] U.S.
dollars (US $ [*] ). Assume further that, for 2005, the
Gross Margin is equal to [*] percent ( [*] %) of Net
Sales. For 2005, the sum of the final Incremental Fee payable to
ICOS pursuant to Section 3.1 would be [*] U.S. dollars (US $
[*] ), calculated as the sum of the following:
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(i) $ [*] of Net
Sales
(ii) $ [*]
[*]
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*Confidential Treatment
Requested.
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(iii) $ [*]
Total = (i)+(ii)+(iii) =$ [*]
This annual fee amount would be
reconciled against the estimated quarterly payments previously made
by Solvay with respect to 2005 sales as contemplated by subsection
(e)(ii) above.
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3.2
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SOLVAY
Reports . Within ten
(10) days after the end of each Sales Quarter, SOLVAY shall provide
ICOS with a preliminary report showing: (i) Gross Sales of the
Product in the Territory for such Sales Quarter and (ii) a
calculation demonstrating the adjustments to Gross Sales in order
to arrive at Net Sales (including a good faith estimate of the
adjustments based on changes in inventory levels for the period).
Within thirty (30) days after the end of each Sales Quarter, SOLVAY
shall provide ICOS with a final report showing: (i) Gross Sales of
the Product in the Territory for such Sales Quarter and (ii) a
calculation demonstrating the adjustments to Gross Sales in order
to arrive at Net Sales; and (iii) a calculation demonstrating the
adjustments to Net Sales in order to arrive at Gross Margin. SOLVAY
will also provide ICOS with monthly reports of Gross Sales for the
Product and sales calls performed in a form and at a time agreed to
by the parties. SOLVAY will also provide ICOS with quarterly
wholesaler inventory reports for the Product to determine changes
in inventory levels in a form and at a time agreed to by the
parties.
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ARTICLE 4
OBLIGATIONS OF
SOLVAY
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4.1
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SOLVAY
Promotional Efforts .
During each calendar year of the term of this Agreement, (a) SOLVAY
Representatives shall perform a minimum of [*] ( [*]
) Sales Calls, and (b) SOLVAY shall provide promotional, marketing,
and advertising support for the Product comparable to the level of
support provided by SOLVAY for the Product in [*] , plus or
minus [*] %. Notwithstanding the foregoing, if the first
and/or last calendar years of the term of this Agreement are not
full calendar years, then the number of Sales Calls and the level
of promotional, marketing, and advertising support required to be
performed or provided by SOLVAY shall be adjusted proportionately.
All Sales Calls by SOLVAY Representatives shall be performed in the
[*] Position Detail, and [*] % of the Incentive
Compensation available to SOLVAY Representatives shall be allocated
to the Product.
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4.2
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Terms of
Sale . All terms of
sale for Product, including, without limitation, policies
concerning pricing, changes to prices, credit terms, cash discounts
and returns and allowances shall be set by SOLVAY. All sales of
Product shall be recorded on the books of SOLVAY. ICOS is not
authorized to negotiate pricing issues with regard to the
Product.
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4.3
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Supply,
Purchase and Sale of the Product . SOLVAY shall offer the Product for sale in the
Territory and shall take all necessary and reasonable actions to
ensure that there is a continuous supply of sufficient quantities
of Product so as to fill promptly all orders for the Product and
otherwise fully supply the market. SOLVAY shall be exclusively
responsible for accepting and filling purchase orders, billing, and
returns with respect to the Product. If ICOS receives an order for
the Product, it shall promptly transmit such order to SOLVAY for
acceptance or rejection, which acceptance or rejection shall be at
SOLVAY’s sole discretion. SOLVAY shall have the sole
responsibility, at its sole cost and expense, for Product shipping,
distribution and warehousing, for the invoicing and billing of
purchasers of the Product, for order confirmation in accordance
with SOLVAY’s customary practices, and for the collection of
receivables resulting from sales of the Product. All sales will be
deemed made pursuant to a contract between SOLVAY and the customer.
Any Product returned or recalled shall be shipped to SOLVAY, with
any reasonable or authorized shipping or other documented direct
cost to be paid by SOLVAY.
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4.4
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Marketing
Programs . ICOS shall
have the ability to provide input on Product marketing, promotion,
and advertising programs through its representation on the
Commercial Committee, as further described in Article 6 below.
Notwithstanding the foregoing, SOLVAY shall have sole
responsibility and discretion for making final decisions regarding
all Product-related marketing and advertising programs, and for
ensuring that all advertising and promotional materials for
AndroGel comply with applicable legal and regulatory
standards.
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*Confidential Treatment
Requested.
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4.5
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Promotional Materials
. SOLVAY shall provide to ICOS, without charge,
sufficient quantities of currently available promotional programs
and materials specific to the Product to enable ICOS to make
effective Sales Calls as required herein. Solvay shall provide ICOS
with vouchers to enable patients to obtain samples of the Product
[*] ; the appropriate amount of vouchers to be provided to
ICOS from time to time shall be discussed by the Commercial
Committee. SOLVAY shall provide access to [*] . Access to
[*] shall be provided at no cost to ICOS, provided that
ICOS’ credited expense for use of [*] , including
[*] , shall not exceed $ [*] per year.
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4.6
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SOLVAY
Assistance . SOLVAY
shall make available to ICOS, at SOLVAY’s expense, a
reasonable number of SOLVAY training, product and sales management
personnel to assist and consult with ICOS’s training, product
and sales management teams with regard to ICOS’s performance
of its obligations hereunder.
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4.7
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Notice to
ICOS .
SOLVAY shall notify ICOS within
forty-eight (48) hours of (a) any recall or market withdrawal of
any lot of Product, and within five (5) business days for (b) any
Warning Letter, Notice of Violation letter, or other communication
from FDA or any other governmental agency related to the marketing,
advertising, promotion, sales, or education efforts related to the
Product, (c) receipt of notice of any other potential regulatory or
legal action related to the Product from FDA or any other
governmental agency, and (d) receipt of any claim or legal action
by a private Third Party related to the marketing, advertising,
promotion, sales, or education efforts related to the Product.
SOLVAY shall conduct any Product recall or market withdrawal in its
sole discretion, shall bear the full costs of such recall, and
shall reimburse ICOS for any actual documented out of pocket costs
or expenses incurred by ICOS as a result of such recall. Subject to
Article 9 below, SOLVAY shall determine in its discretion any
response to any communicati
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