|
Exhibit
10.1
|
|
|
|
|
| |
|
|
|
*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. |
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
| 1. |
Definitions . In this Agreement, the following
terms shall have the following meanings, except where the context
otherwise requires: |
| 1.1 |
“ 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. |
| 1.2 |
“ [*] Position Detail ” means a
presentation of the Product to a licensed prescriber by a
Representative in which the Product [*] . |
| 1.3 |
“ 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. |
| 1.4 |
“GAAP” means generally accepted
accounting principles in the United States. |
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
| 1.5 |
“ 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: |
(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.
| 1.6 |
“ 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. |
| 1.7 |
“ Net Sales ” means Gross Sales less
the following, all as calculated in accordance with
GAAP: |
(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 [*] .
| 1.8 |
“ 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. |
| 1.9 |
“ 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. |
| 1.10 |
“ 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. |
| 1.11 |
“ Sales Call ” means a presentation
to a member of the Target Audience by a Representative during which
such Representative promotes the Product. |
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
| 1.12 |
“ 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. |
| 1.13 |
“ [*] Position Detail ” means
a presentation of the Product to a licensed prescriber by a
Representative in which the Product [*] . |
| 1.14 |
“ 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. |
| 1.15 |
“ Target Audience ” means [*]
. |
| 1.16 |
“ Territory ” means the United
States, exclusive of Alaska, Hawaii, Puerto Rico, and the other
territories and possessions of the United States. |
| 1.17 |
“Third Party” means any entity or
individual other than SOLVAY or ICOS or their respective
Affiliates. |
ARTICLE 2
OBLIGATIONS OF
ICOS
| 2.1 |
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 [*]
. |
| 2.2 |
Scope of Co-Promotion Activities . ICOS
Representatives shall perform Sales Calls on the Target Audience as
follows: |
| |
(a) |
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: |
(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.
| |
(b) |
All Sales Calls by ICOS Representatives shall be performed in
the [*] Position Detail or [*] Position Detail, to
the Target Audience. |
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
| |
(c) |
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: |
(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 [*]
.
| |
(d) |
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. |
| |
(e) |
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. |
| 2.3 |
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. |
| 2.4 |
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. |
| 2.5 |
ICOS Programs . ICOS agrees to evaluate,
[*] . ICOS also agrees to review [*] . |
| 2.6 |
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 [*] . |
| 2.7 |
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. |
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
| 2.8 |
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. |
| 2.9 |
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. |
ARTICLE 3
CONSIDERATION
| 3.1 |
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: |
| |
(a) |
For the period from January 1 through December 31, 2005, SOLVAY
shall pay ICOS an Incremental Fee equal to: |
| |
(i) |
[*] percent ( [*] %) of the Gross Margin
associated with Net Sales less than [*] U.S. dollars (US $
[*] ); |
| |
(ii) |
[*] 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. $ [*] ); |
| |
(iii) |
[*] 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 |
| |
(iv) |
[*] percent ( [*] %) of the Gross Margin
associated with Net Sales in excess of [*] U.S. dollars
(U.S. $ [*] ). |
| |
(b) |
For the period from January 1, 2006 through December 31, 2006,
SOLVAY shall pay ICOS an Incremental Fee equal to: |
| |
(i) |
[*] percent ( [*] %) of the Gross Margin
associated with Net Sales less than [*] U.S. dollars (US $
[*] ); |
| |
(ii) |
[*] 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 |
| |
(iii) |
[*] percent ( [*] %) of the Gross Margin
associated with Net in excess of [*] U.S. dollars (U.S. $
[*] ). |
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
| |
(c) |
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 [*]
. |
| |
(d) |
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. |
| |
(e) |
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. |
(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.
| |
(f) |
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: |
(i) $ [*] of Net
Sales
(ii) $ [*]
[*]
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
(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.
| 3.2 |
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. |
ARTICLE 4
OBLIGATIONS OF
SOLVAY
| 4.1 |
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. |
| 4.2 |
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. |
| 4.3 |
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. |
| 4.4 |
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. |
|
|
|
|
|
| |
|
|
|
*Confidential Treatment Requested. |
| 4.5 |
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. |
| 4.6 |
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. |
| 4.7 |
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
co |
|
