[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
ELESTAT
™
(EPINASTINE) CO-PROMOTION
AGREEMENT
THIS ELESTAT
™
(EPINASTINE) CO-PROMOTION
AGREEMENT is entered into
as of December 8 th , 2003 by and between ALLERGAN
SALES, LLC. , a Delaware limited liability company (formerly
ALLERGAN SALES, INC ., a Delaware corporation), having an
address of 2525 Dupont Drive, Irvine, California 92612 (hereinafter
referred to as “ ALLERGAN ”), and INSPIRE
PHARMACEUTICALS, INC. , a Delaware corporation, having an
address of 4222 Emperor Boulevard, Suite 200, Durham, North
Carolina 27703 (hereinafter referred to as “ INSPIRE
”).
RECITALS
WHEREAS, INSPIRE and ALLERGAN and
its Affiliates, Allergan, Inc. and Allergan Pharmaceuticals
Holdings (Ireland) Ltd., are parties to that certain License,
Development and Marketing Agreement dated as of June 22, 2001, as
amended (the “ Restasis/INS365 Agreement ”),
under which INSPIRE, among other things, is retaining sales
representatives and building a sales force; and
WHEREAS, ALLERGAN has exclusive
rights to Elestat in the Territory (as each is hereinafter defined)
by virtue of a Development and License Agreement dated December 15,
1999 (the “ Existing Agreement ”) with Boeringer
Ingelheim International GmbH (“ BII ”);
and
WHEREAS, ALLERGAN has received
Regulatory Approval (as hereinafter defined) to market and sell
Elestat in the Territory; and
WHEREAS, INSPIRE desires to provide
a professional Sales Force (as hereinafter defined), and ALLERGAN
desires to engage such Sales Force, to Call on the Field of Use (as
each such term is hereinafter defined), all subject to the terms
and conditions set forth in this Agreement (as hereinafter
defined).
AGREEMENT
NOW, THEREFORE, in consideration of
the foregoing premises and the mutual covenants contained herein
and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties agree as
follows:
1.1 “ AAA ” shall
have the meaning assigned to such term in Section 12.9.1
hereof.
1.2 “ ACCME ”
shall have the meaning assigned to such term in Section 3.2.3
hereof.
1.3 “ ACCME Standards
” shall have the meaning assigned to such term in Section
3.2.3 hereof.
1.4 “ Adverse Reaction
Reports ” shall have the meaning assigned to such term in
Section 6.2.2 hereof.
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
1.5 “ Affiliate ”
shall mean, with respect to a party, any individual, sole
proprietorship, firm, partnership, corporation, trust, joint
venture or other entity, whether de jure or de facto, which,
directly or indirectly, controls, is controlled by or is under
common control with such party. As used in this definition, “
control ” means the possession, directly or
indirectly, of the power to direct or cause the direction of the
policies and management of a person or entity, whether by the
ownership of stock, by contract or otherwise.
1.6 “ Agreement ”
shall mean this Elestat ™ (Epinastine) Co-Promotion Agreement together
with all appendices, exhibits and schedules hereto, as the same may
hereinafter be amended or supplemented from time to time in
accordance with the Agreement.
1.7 “ ALLERGAN ”
shall have the meaning assigned to such term in the preamble
hereof.
1.8 “ ALLERGAN Indemnified
Claim ” shall have the meaning assigned to such term in
Section 10.2.2 hereof.
1.9 “ ALLERGAN Indemnified
Parties ” shall have the meaning assigned to such term in
Section 10.2.1 hereof.
1.10 “ AMA ”
shall have the meaning assigned to such term in Section 3.2.2
hereof.
1.11 “ AMA Guidelines
” shall have the meaning assigned to such term in Section
3.2.2 hereof.
1.12 “ Anti-Kickback
Statute ” shall have the meaning assigned to such term in
Section 3.2.2 hereof.
1.13 “ Applicable Laws
” shall mean: (a) all applicable federal, state and local
laws, ordinances, rules and regulations applicable to this
Agreement or the activities contemplated hereunder, including
without limitation, the FD&C Act and equivalent state laws and
regulations, whether such laws and regulations are now or hereafter
in effect; and (b) any requirements under any license agreement
applicable to Elestat in the Territory including, without
limitation, the Existing Agreement.
1.14 “ BII ”
shall have the meaning assigned to such term in the
recitals.
1.15 “ Breaching Party
” shall have the meaning assigned to such term in Section
8.2.
1.16 “ Calendar Quarter
” shall mean each of the three (3) month periods commencing
with January 1st, April 1st, July 1st and October 1st and ending,
respectively, on the following March 31st, June 30th, September
30th and December 31 st .
1.17 “ Call ”
shall mean a visit by a member of the Sales Force to the Field of
Use.
1.18 “ cGMP ”
shall mean current Good Manufacturing Practice as promulgated under
and in accordance with the U.S. Federal Food, Drug, and Cosmetic
Act, Title 21 of the U.S. Code of Federal Regulations Parts 210 and
211, as such may be amended from time to time, or any successor
thereto.
2
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
1.19 “ Commercial Year
” shall mean the First Commercial Year and thereafter each
calendar year of 365 days (or 366 days in a leap year) during the
Term; provided that the last Commercial Year shall end on
the final day of the Term.
1.20 “ Confidential
Information ” shall have the meaning assigned to such
term in Section 11.1.1 hereof.
1.21 “ Definitive
Agreement ” shall have the meaning assigned to such term
in Section 3.10.1 hereof.
1.22 “ Direct
Competitor ” shall mean any Third Party that
manufactures, markets or sells any then currently promoted
prescription ophthalmic product.
1.23 “ Effective Date
” shall mean the date set forth in the preamble
hereof.
1.24 “ Elestat ”
shall mean ALLERGAN’s proprietary ophthalmic anti-allergy
product epinastine ophthalmic solution 0.05%, in finished
pharmaceutical form, in any formulation, packaged for sale (or, as
applicable, distribution as samples) to Third Parties.
1.25 “ Elestat Labeling
” shall mean: (a) the FDA full prescribing information for
Elestat, including any required patient information; and (b) all
labels and other written, printed or graphic matter upon any
container, wrapper or any package insert or outsert utilized with,
or for, Elestat.
1.26 “ Elestat Tail
Payments ” shall have the meaning assigned to such term
in Section 4.2.1 hereof.
1.27 “ Elestat Tail
Year ” shall mean [confidential treatment requested]
twelve (12)-month periods following the expiration or termination
of this Agreement; the first such Elestat Tail Year shall commence
on the first day after the effective date of such termination or
expiration and end on the last day of the last month of such twelve
(12)-month period and so on year-by-year.
1.28 “ Existing
Agreement ” shall have the meaning assigned to such term
in the recitals hereof.
1.29 “ FDA ”
shall mean the United States Food and Drug Administration or any
successor entity.
1.30 “ FD&C Act
” shall mean the United States Federal Food, Drug and
Cosmetics Act, Title 21 of the U.S. Code Section 321 et seq
., as amended, and the regulations promulgated thereunder from time
to time.
1.31 “ Field of Use
” shall mean the fields of Ophthalmology, Optometry and
Allergist prescribers.
3
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
1.32 “ First Commercial
Year ” shall mean the period commencing on the Effective
Date and ending on December 31, 2004.
1.33 “ GAAP ”
shall mean generally accepted accounting principles in the United
States, consistently applied by the party at issue.
1.34 “ Information
” shall have the meaning assigned to such term in Section
11.1.1 hereof.
1.35 “ INSPIRE ”
shall have the meaning assigned to such term in the preamble
hereof.
1.36 “ INSPIRE Indemnified
Claim ” shall have the meaning assigned to such term in
Section 10.1.2 hereof.
1.37 “ INSPIRE Indemnified
Parties ” shall have the meaning assigned to such term in
Section 10.1.1 hereof.
1.38 “ IMS ”
shall mean IMS Health Incorporated or any successor
organization.
1.39 “ JCC ” or
“ Joint Commercialization Committee ” shall mean
the Joint Commercialization Committee formed by the parties
pursuant to the Restasis/INS365 Agreement to coordinate marketing,
promotion and detailing strategies, plans and budgets under such
Restasis/INS365 Agreement.
1.40 “ Liabilities
” shall have the meaning assigned to such term in Section
10.1.1 hereof.
1.41 “ Marketing Plan
” and “ Marketing Plans ” shall have the
meanings assigned to such terms in Section 2.2.
1.42 “ Marketing Costs
” shall have the meaning assigned to such term in Section 3.4
hereof.
1.43 “ NDA ”
shall mean a New Drug Application in the U.S. as defined in Title
21 of the U.S. Code of Federal Regulations, Section 314.50, et.
seq.
1.44 “ Net Sales”
shall mean the gross amount invoiced for sales of Elestat by
ALLERGAN, or its Affiliates, in arm’s length sales to Third
Parties in the Territory, less the following deductions from such
gross amounts which are actually incurred, allowed, accrued or
specifically allocated:
(a) credits or allowances for
damaged products, returns or rejections of Elestat and retroactive
price reductions;
(b) normal and customary trade, cash
and quantity discounts, allowances and credits;
4
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
(c) chargeback payments, rebates and
fees (or the equivalent thereof) granted or paid to managed health
care organizations or to federal, state/provincial, local and other
governments, including their agencies, or to trade
customers;
(d) commissions paid to Third
Parties other than sales personnel, sales representatives and sales
agents;
(e) the allocation of freight,
postage, shipping (including insurance) and other transportation;
and
(f) sales, value-added and excise
taxes, tariffs and duties, and other taxes directly related to the
sale (but not including taxes assessed against the income derived
from such sale).
1.45 “ Non-serious Adverse
Drug Experience ” shall have the meaning assigned to such
term in Section 6.2.1 hereof.
1.46 “ Non-breaching
Party ” shall have the meaning assigned to such term in
Section 8.2 hereof.
1.47 “ Notice ”
shall have the meaning assigned to such term in Section 3.10.1
hereof.
1.48 “ Outdated Stock
” shall have the meaning assigned to such term in Section
4.3.2.
1.49 “ PDMA ”
shall mean the Prescription Drug Marketing Act of 1987, Title 21 of
the U.S. Code of Federal Regulations, Parts 203 and 205, as
amended, and any final regulations or guidances promulgated
thereunder from time-to-time.
1.50 “ PhRMA ”
and “ PhRMA Code ” shall have the meanings
assigned to such terms in Section 3.2.2 hereof.
1.51 “ Presentation
” shall mean a Primary or Secondary Presentation.
1.52 “ Primary
Presentation ” shall mean a Call during which key product
attributes of Elestat are verbally promoted and detailed in the
first (or only) position on such Call; provided, however ,
that: (1) no more than one presentation in any Call shall be
considered a Primary Presentation; and (2) a majority of the Call
time shall be spent detailing Elestat during the Call.
1.53 “ Promotional
Materials ” shall mean all sales representative training
materials and all written, printed, graphic, electronic, audio or
video matter, including, but not limited to, journal
advertisements, sales aids, formulary binders, reprints, direct
mail, direct-to-consumer advertising, Internet postings, broadcast
advertisements and sales reminder aids (for example, scratch pads,
pens and other such items), in each case created by a party, or on
its behalf, and used or intended for use by INSPIRE in connection
with any promotion of Elestat hereunder, but excluding Elestat
Labeling.
1.54 “ Proposal ”
shall have the meaning assigned to such term in Section 3.10.1
hereof.
5
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
1.55 “ Regulatory
Approval ” shall mean all approvals (including, but not
limited to, NDA approval, labeling, pricing and reimbursement
approvals), product, biologic and/or establishment licenses,
registrations or authorizations of any federal, state or local
regulatory agency, department, bureau or other governmental entity,
which are necessary for the commercial manufacture, use, storage,
importation, export, transport or sale of Elestat in the
Territory.
1.56 “ Restasis/INS365
Agreement ” shall have the meaning assigned to such term
in the recitals.
1.57 “ Revised Net
Sales ” shall mean Net Sales multiplied by the fraction
A/B where: (a) A is equal to the total prescriptions filled for
Elestat in the Field of Use in the Territory, for a given period;
and (b) B is equal to the total prescriptions filled for Elestat in
the Territory, for a given period; as reported by IMS, Verispan or
other mutually agreed upon reliable data source.
1.58 “ Sales Force
” shall mean INSPIRE’s sales personnel primarily
calling on the Field of Use.
1.59 “ Secondary
Presentation ” shall mean a Call during which key product
attributes of Elestat, are verbally promoted and detailed in the
second position on such Call; provided, however, that no
more than one presentation in any Call shall be considered a
Secondary Presentation.
1.60 “ Serious Adverse Drug
Experience ” shall have the meaning assigned to such term
in Section 6.2.1 hereof.
1.61 “ Standard Unit
Cost ” shall mean ALLERGAN’s standard unit cost to
manufacture Elestat including direct labor, direct material and
overhead and all direct and indirect product costs incident to and
necessary for production or manufacturing operations or processes,
all according to GAAP applied on a consistent basis.
1.62 “ Term ”
shall have the meaning assigned to such term in Section 8.1
hereof.
1.63 “ Territory
” shall mean the United States and its territories and
possessions.
1.64 “ Third Party
” shall mean any entity other than ALLERGAN or INSPIRE or an
Affiliate of ALLERGAN or INSPIRE.
1.65 “ Trademarks
” shall mean: (a) with respect to ALLERGAN, the logos,
trademarks, trade names and service marks of ALLERGAN listed as
ALLERGAN’s on Schedule A attached hereto, such marks
being owned and registered by ALLERGAN or exclusively licensed to
ALLERGAN by BII or an ALLERGAN Affiliate; and (b) with respect to
INSPIRE, the logos, trademarks, trade names and service marks of
INSPIRE listed as INSPIRE’s on Schedule A attached
hereto, such marks being owned and registered by
INSPIRE.
6
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
1.66 “ United States
” or “ U.S. ” shall mean The United States
of America.
1.67 “ Urgent Regulatory
Information ” shall have the meaning assigned to such
term in Section 6.2.1 hereof
|
2.
|
OBJECTIVES;
MANAGEMENT.
|
2.1 Management; The JCC
.
2.1.1 It is the objective of the
parties to market, promote and detail Elestat to the Field of Use
during the Term in accordance with the provisions of this
Agreement. In order to coordinate their efforts, management of the
parties activities hereunder shall be the responsibility of the
Joint Commercialization Committee. In addition to its obligations
under the Restasis/INS365 Agreement, the JCC shall meet at mutually
agreeable times and locations, but in no case less than once per
Calendar Quarter, to formulate, coordinate, and implement Marketing
Plans for Elestat and to make any determinations required under
this Agreement including, without limitation, Sections 3.3, 3.12,
6.3 and 11.1.3. Meetings will be conducted according to the
procedures set out in, and the JCC shall be governed by and all
decisions shall be made in accordance with, the provisions of
Sections 6.1, 6.3, 6.4 and 6.5 of the Restasis/INS365 Agreement;
provided however, that if the JCC Executive Officers (as
that term is defined in the Restasis/INS365 Agreement) cannot reach
a mutually acceptable decision within fifteen (15) days after a
matter in dispute under this Agreement has been referred to them,
then INSPIRE, subject to Section 3.4 shall have final
decision-making authority with respect to disputes relating to the
promotion and detailing of Elestat, and ALLERGAN shall have final
decision-making authority with respect to disputes relating to: (1)
material legal issues that could reasonably be expected to
adversely impact the Regulatory Approvals; (2) pricing, product
positioning, sales strategy and channel placement of Elestat; or
(3) regulatory compliance issues; except that all decisions
of the JCC relating to allocation of costs described in subsections
(e), (f) and (g) of Section 2.1.2 must be made by unanimous
decision of the JCC members.
2.1.2 In addition to the
responsibilities set forth elsewhere in this Agreement, the JCC
shall provide input and recommendations regarding the marketing of
Elestat to the Field of Use during the Term, and shall, without
limitation, perform the following functions:
(a) review and approve each
Marketing Plan in accordance with the procedure set forth in
Section 2.2;
(b) review and approve decisions
relating to pricing, product positioning, sales strategy, supply
chain management including pipeline inventory and channel placement
of Elestat;
(c) determine the overall product
strategy for Elestat under this Agreement and review all major
promotional, sales and strategic decisions;
7
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
(d) provide a mechanism for the
exchange of Information between the parties;
(e) review and approve any
recommended or required post-Regulatory Approval clinical trials
including, without limitation, determinations regarding the
necessity for such clinical trials and an appropriate allocation
between the parties of the costs for same;
(f) oversee, approve and coordinate
any additional communication activities or other strategic
marketing activities to be undertaken during the Term, including,
without limitation, a determination of an appropriate allocation
between the parties of the costs for same;
(g) review, approve and coordinate
any additional services/activities contemplated in this Agreement
to be provided by INSPIRE to assist ALLERGAN in performing its
responsibilities hereunder including, without limitation, those set
forth in Section 3.12, along with an appropriate allocation between
the parties of the costs for same;
(h) review and provide guidance with
respect to any actual or anticipated difficulties ALLERGAN is
encountering in meeting market demand for Elestat; and
(i) if ALLERGAN decides to develop a
line extension to Elestat during the Term, ALLERGAN will promptly
inform INSPIRE and negotiate in good faith through the JCC to reach
a development and commercialization agreement for such line
extension with INSPIRE.
(j) such other functions as may be
assigned to the JCC pursuant to this Agreement or as may be agreed
upon by the parties, in writing, from time to time.
2.2 Marketing Plan . Inspire
shall submit a detailed marketing plan for Elestat in the Field of
Use covering the first three Commercial Years ( i.e. ,
through December 31, 2006) within thirty (30) days of the Effective
Date and, thereafter, for the fourth Commercial Year and each
subsequent Commercial Year, not later than August 1 of the prior
Commercial Year (each a “ Marketing Plan ” and,
collectively, the “ Marketing Plans ”), to the
JCC for its review and which shall be approved by the JCC within
thirty (30) days in order to allow the proper lead time for
production of product requirements. Each Marketing Plan shall
include: (a) a comprehensive marketing, promotion and detailing
strategy for Elestat in the Field of Use; (b) a good faith sales
forecast (which shall be consistent with, and in addition to, the
forecasts provided pursuant to Section 3.11.6); and (c) a budget of
Marketing Costs . The Marketing Plans shall also include a
unit forecast, by month, of the number of samples required by
INSPIRE. ALLERGAN hereby agrees that it shall be responsible for
and shall provide the data, information and cooperation reasonably
requested by INSPIRE to produce and implement each Marketing Plan.
Although the parties intend to work cooperatively, INSPIRE shall be
the party responsible for implementing the activities referenced in
the Marketing Plan.
3.1 Grant . During the Term,
and subject to the terms and conditions of this Agreement, ALLERGAN
hereby grants to INSPIRE the exclusive right to co-promote and
detail
8
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
Elestat under this Agreement under
ALLERGAN’s Trademarks in the Field of Use in the Territory.
This provision shall not preclude ALLERGAN from marketing,
promoting and detailing Elestat (or, subject to Section 3.10,
granting to Third Parties the right to market, promote and detail
Elestat): (a) outside the Field of Use; or (b) outside the
Territory. This provision shall also not preclude ALLERGAN from
marketing, co-marketing, promoting, co-promoting and detailing any
other product in the Field of Use in the Territory.
3.2 Promotion Efforts .
During the Term, and subject to the terms and conditions of this
Agreement, INSPIRE shall, in cooperation with ALLERGAN, use
commercially reasonable efforts to market, promote and detail
Elestat utilizing qualified field sales staff as its Sales Force in
accordance with the then-current Marketing Plan. In addition, each
party agrees:
3.2.1 that ALLERGAN shall have the
exclusive right and obligation to manage reimbursement for Elestat
in the appropriate reimbursement channels (health maintenance
organizations, pharmacy benefit management companies and
institutional customers); provided that: (1) ALLERGAN shall
use the same diligence it employs with respect to similar products
of similar commercial size in the ophthalmology and allergy
therapeutic areas to such entities and institutions and (2) INSPIRE
shall be fully updated of all ALLERGAN efforts through the JCC
meetings. In carrying out its obligations under this Section 3.2.1,
ALLERGAN agrees to [confidential treatment requested].
3.2.2 that each party shall, in all
material respects, conform its practices and procedures relating to
the marketing, detailing and promotion of Elestat to all Applicable
Laws and guidelines, including the PDMA, the Federal Health Care
Programs Anti-Kickback Law, Title 42 of the U.S. Code Section
1320a-7b(b) (the “ Anti-Kickback Statute ”), the
Pharmaceutical Research and Manufacturers of America (“
PhRMA ”) Code of Pharmaceutical Marketing Practices
(the “ PhRMA Code ”) and the American Medical
Association (“ AMA ”) Guidelines on Gifts to
Physicians from Industry (the “ AMA Guidelines
”), as the same may be amended from time to time, and shall
promptly notify the other party of, and provide the other party
with a copy of, any correspondence or other reports with respect to
the marketing, detailing and promotion of Elestat submitted to or
received from the U.S. Department of Health and Human Services or
its components (including the FDA and the Office of the Inspector
General), PhRMA or the AMA relating to such laws, regulations and
guidelines;
3.2.3 that each party shall, in all
material respects, conform its practices and procedures relating to
educating the medical community in the United States with respect
to Elestat to the Accreditation Council for Continuing Medical
Education (“ ACCME ”) Standards for Commercial
Support of Continuing Medical Education (the “ ACCME
Standards ”) and any applicable and enforceable FDA
regulations or guidelines, as the same may be amended from time to
time, and promptly notify the other party of, and provide the other
party with a copy of, any correspondence or other reports submitted
to or received from the ACCME with respect to Elestat relating to
the ACCME Standards or such FDA regulations;
3.2.4 that each party shall, in
connection with the promotion and detailing of Elestat hereunder,
make no statement, representation or warranty, oral or written, to
Third Parties, concerning Elestat that is inconsistent with, or
contrary to, the Elestat Labeling or Promotional Materials;
and
9
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
3.2.5 that each party shall, in all
material respects, conform its practices and procedures relating to
sampling in the Territory to sampling practices and procedures in
compliance with the PDMA.
3.3 Detailing Requirements .
During each Commercial Year, INSPIRE shall use commercially
reasonable efforts to market, promote and detail Elestat to the
Field of Use in the Territory. INSPIRE further agrees to use
commercially reasonable efforts to have its Sales Force provided a
minimum of [confidential treatment requested] Calls during each
month (which amount shall be prorated for any periods of less than
a month) of the spring and fall allergy seasons (as determined by
the JCC) with the Sales Force as provided in Section 3.6. During
such spring and fall allergy seasons, INSPIRE agrees that the sales
detail commitment shall be, at a minimum, a Secondary Presentation
for all called upon physicians in the Field of Use. INSPIRE shall
maintain records of Calls made by its Sales Force that will
accurately represent the number of Primary and Secondary
Presentations made for Elestat in the Field of Use. During the
Term, INSPIRE shall issue reports to ALLERGAN within thirty (30)
days after the end of each month showing the number of Primary and
Secondary Presentations made in the Field of Use for Elestat.
Additionally, for the first six (6) months of this Agreement,
INSPIRE shall provide ALLERGAN with an accurate weekly report of
total prescriptions for Elestat in the Field of Use for the
preceding week, to the extent that such data is available on a
timely basis from IMS. ALLERGAN shall be entitled to audit the
source data and documents used to compile such reports pursuant to
the provisions of Article 7.
3.4 Marketing Costs . INSPIRE
shall bear all cost and expense of its marketing, promotion,
advertising, and detailing activities hereunder including, without
limitation, its costs to develop and create Promotional Materials
(as set forth in the budget of the applicable Marketing Plan and
approved by the JCC), as well as the costs associated with its
Sales Force occasionally performing minor administrative functions
in support of ALLERGAN’s customer support activities. INSPIRE
agrees its annual out-of-pocket costs for promotion and advertising
(excluding detailing and Sales Force costs) (“ Marketing
Costs ”) shall not be less than two million dollars
($2,000,000) for the First Commercial Year and each Commercial Year
thereafter (which amount shall be prorated for any Commercial Year
of less than twelve (12) months) during the Term.
3.5 Samples . Notwithstanding
any other provision of this Agreement, all product samples supplied
by ALLERGAN to INSPIRE shall be delivered to INSPIRE’s Sales
Force at ALLERGAN’s Standard Unit Cost plus shipping and
handling expenses. ALLERGAN shall ship the samples, at least
quarterly, along with an invoice for same, to INSPIRE in accordance
with the month-by-month forecast for samples set forth in the
Marketing Plan for such Commercial Year, payment to be made by
INSPIRE within thirty (30) days of delivery. INSPIRE shall be
entitled to audit ALLERGAN’s calculation of Standard Unit
Cost, as well as shipping and handling expenses pursuant to the
provisions of Article 7 hereof.
3.6 Sales Force . INSPIRE
hereby agrees that no later than forty five (45) days after the
later of: (a) the first physical shipment of Elestat to the trade
by ALLERGAN; or (b) January 1, 2004;
10
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
and thereafter through-out the Term, the Sales
Force shall be comprised of [confidential treatment requested]
sales persons who are full time employees of INSPIRE and that are
making Calls on the Field of Use. INSPIRE shall not permit any of
its sales personnel to promote Elestat unless such sales personnel
have been fully trained and qualified in accordance with Section
3.11.3. INSPIRE shall be responsible for the compliance of its
Sales Force with all relevant terms of this Agreement and the
Marketing Plan. INSPIRE shall give prompt written notice to
ALLERGAN of the date on which the Sales Force commences promoting
Elestat in the Field of Use hereunder.
3.7 Proprietary Rights in
Elestat . Except as may be necessary for INSPIRE to market,
promote and detail Elestat as contemplated in this Agreement: (a)
ALLERGAN retains and shall at all times retain all proprietary
rights and proprietary interests in Elestat until sold by Allergan;
and (b) INSPIRE will neither have nor represent that it has any
control or proprietary or property interests in Elestat. Except
with respect to ALLERGAN’s Trademarks or as otherwise as set
forth in this Agreement, nothing contained herein shall be deemed
to grant INSPIRE a license or other right or interest in any
patent, trademark, copyright or other similar intellectual property
of ALLERGAN.
3.8 Promotional Materials
.
3.8.1 During the Term, other than
launch materials and any materials that have been created by
ALLERGAN and approved by the JCC for use by INSPIRE, INSPIRE shall
create and develop Promotional Materials relating to Elestat
consistent with the Marketing Plan, it being understood that: (1)
the costs of all Promotional Materials created by INSPIRE shall be
borne by INSPIRE pursuant to Section 3.4; and (2) ALLERGAN shall
provide all materials reasonably requested by INSPIRE in order to
create and develop such Promotional Materials. All Promotional
Materials shall be subject to review and approval by
ALLERGAN’s Regulatory Compliance Department, such approval
not to be unreasonably withheld or delayed. The parties shall
establish a tracking system, or utilize ALLERGAN’s tracking
system (if appropriate and mutually agreed), for Promotional
Materials to ensure that all such Promotional Materials are
accurately tracked and submitted to the FDA. ALLERGAN will file all
Promotional Materials with the FDA if and as required by FDA
regulations.
3.8.2 Except as otherwise provided
in this Agreement, neither party shall distribute or have
distributed any materials including, for the avoidance of doubt,
any Promotional Materials bearing the name of the other without the
prior written approval of such party.
3.8.3 ALLERGAN shall own all right,
title and interest in and to the Promotional Materials, including
all copyrights appurtenant thereto. For purposes of clarification,
ALLERGAN acknowledges and agrees that it is obtaining no rights in
or to any trademarks owned by INSPIRE (including, for the avoidance
of doubt, INSPIRE’s Trademarks) or any copyrighted or
copyrightable materials related to INSPIRE’s business or any
products marketed and sold by INSPIRE. ALLERGAN hereby grants to
INSPIRE the right, during the Term, to use all Promotional
Materials generated pursuant to a Marketing Plan in connection with
its marketing, promotion and detailing of Elestat hereunder.
INSPIRE agrees that ALLERGAN may use any promotional, Phase IV or
marketing materials generated by INSPIRE outside the Territory
without charge.
11
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
3.9 ALLERGAN Responsibilities
. ALLERGAN shall, at its expense, have the sole right and shall
take such actions with respect to Elestat as would normally be done
in accordance with accepted business practices and legal
requirements, to maintain the authorization and/or ability to
market Elestat in the Territory, including, without limitation, the
following:
3.9.1 Maintaining all required
Regulatory Approvals in the Territory at its expense, including
without limitation, filing NDA annual reports as
required.
3.9.2 Manufacturing Elestat
according to cGMP and Applicable Laws (so that at the time of
shipment Elestat will not be misbranded or adulterated under the
FD&C Act) based on forecasts to be supplied by INSPIRE in
accordance with Section 3.11.6. ALLERGAN agrees to use commercially
reasonable efforts to maintain adequate days of stock of Elestat in
its inventory to promptly fill orders in the Territory, subject to
Section 12.8.
3.9.3 Booking sales and distribution
of Elestat hereunder and performance of related services all in
accordance with Applicable Laws. If INSPIRE receives any orders for
Elestat in the Territory during the Term, it shall promptly refer
such orders to ALLERGAN. Commencing with the month in which the
first commercial sale of Elestat in the Territory occurs, and
thereafter on a monthly basis, ALLERGAN shall provide to INSPIRE
within twenty (20) days after the close of each month a written
sales report of Elestat sales for the preceding month which report
shall be considered Confidential Information of ALLERGAN subject to
restrictions set forth in Article 11 and shall be used by INSPIRE
for internal business purposes only and INSPIRE acknowledges that
notwithstanding any other term of this Agreement, it shall be a
material breach of this Agreement if INSPIRE breaches the terms of
this Section 3.9.3 including, without limitation, disclosing said
sales report or any portion thereof to investors, analysts or other
Third Parties or providing opinions or financial projections to
Third Parties based in whole or in part on said sales reports;
except that INSPIRE may use said sales report to assist it
to estimate its quarterly revenue and report the same as required
by law after ALLERGAN’s public release of its corresponding
quarterly earnings statement. Notwithstanding the foregoing,
INSPIRE agrees that it will obtain prior written consent from
ALLERGAN before making public any sales data obtained from ALLERGAN
on sales of Elestat, other than quarterly and annual Elestat
sales and forecasts of said sales in the Territory.
3.9.4 Administer trade relations,
order processing, invoicing, credit and collection, inventory and
receivables, chargebacks/rebates, and the overall supply chain
management in order to fill orders to wholesalers.
3.9.5 Providing customer support,
including handling medical queries, and performing other functions
consistent with consumer practice for prescription pharmaceuticals
and with the Marketing Plans; except that INSPIRE will be
responsible to supply physician ordered samples and related
administration.
12
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
3.9.6 Responding to product and
medical complaints relating to Elestat.
3.9.7 Handling all returns of
Elestat.
3.9.8 Handling all voluntary recalls
and market withdrawals of Elestat. INSPIRE will make available to
ALLERGAN, upon request and at its expense, all of INSPIRE’s
pertinent records on Elestat that ALLERGAN may reasonably require
to assist it in effecting any recall or market
withdrawals.
3.9.9 Communicating with any
governmental agencies and satisfying their requirements regarding
Regulatory Approvals of Elestat in the Territory as more fully set
forth in Section 6.2.3.
3.9.10 Reporting Adverse Reaction
Reports to U.S. regulatory authorities as required by Applicable
Law.
3.10 Right of First Refusal .
If at any time during the Term, ALLERGAN desires to enter into an
agreement with any Third Party to market, promote and/or detail
Elestat outside the Field of Use in the Territory, ALLERGAN agrees
as follows:
3.10.1 In the event that ALLERGAN
and such Third Party reach agreement as to the terms of such an
agreement, whether in the form of a proposed term sheet or
non-binding letter of intent (collectively, a “
Proposal ”) ALLERGAN agrees to promptly notify INSPIRE
in writing of such Proposal, which notification shall include a
complete description of the terms of such Proposal (the “
Notice ”). INSPIRE shall have [confidential treatment
requested] after receipt of the Notice to notify ALLERGAN if it is
willing to enter into an agreement for such rights outside the
Field of Use. During such [confidential treatment requested] period
and, if INSPIRE notifies ALLERGAN of its willingness to enter into
such an agreement on comparable or more favorable terms, ALLERGAN
agrees to cease negotiations with the Third Party regarding the
Proposal and INSPIRE and ALLERGAN shall promptly commence good
faith negotiations, for a period of up to [confidential treatment
requested], in an effort to reach a mutually acceptable definitive
agreement for such marketing and promotion arrangement (a
“Definitive Agreement”).
3.10.2 If, despite each
party’s good faith efforts, ALLERGAN and INSPIRE are not able
to reach agreement on and do not execute a Definitive Agreement
within such [confidential treatment requested] period, ALLERGAN
shall be free to enter into such an agreement regarding such
licensing arrangement; provided, however , that the terms
and conditions of any agreement with a Third Party taken as a whole
shall be no more favorable to such Third Party than the material
terms and conditions last offered by INSPIRE during the
parties’ good faith negotiations.
3.10.3 If INSPIRE fails to contact
ALLERGAN within the [confidential treatment requested] period or
notifies ALLERGAN that it does not wish to enter into an agreement
to market, promote and/or detail Elestat outside the Field of Use
in the Territory under any terms, ALLERGAN may proceed to enter
into an agreement with the Third Party signatory of the Proposal or
any other Third Party. If, however, INSPIRE
13
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
notifies ALLERGAN that it is
interested in acquiring the rights to market, promote and/or detail
Elestat outside the Field of Use in the Territory but not on the
terms set forth in the Proposal, ALLERGAN may proceed to enter into
an agreement with the Third Party signatory of the Proposal;
provided, however , that the material terms and conditions
of any agreement with such Third Party taken as a whole shall be
consistent with and in no case more favorable to such Third Party
than the terms and conditions set forth in the original
Proposal.
3.10.4 ALLERGAN shall promptly
notify INSPIRE upon the execution of any agreement with a Third
Party to market, promote and/or detail Elestat outside the Field of
Use in the Territory, and shall provide a copy of the signed
agreement to INSPIRE upon its request if: (1) the parties were
unable to reach agreement on a Definitive Agreement under Section
3.10.2; or (2) INSPIRE, under Section 3.10.3, notifies ALLERGAN of
its interest in obtaining such rights, but not on the terms set
forth in the Proposal.
3.10.5 If, upon any expiration or
waiver of the right of first refusal set forth in this Section
3.10, ALLERGAN enters into an agreement with any Third Party to
market, promote and/or detail Elestat outside the Field of Use in
the Territory, INSPIRE’s compensation hereunder shall be
calculated based on Revised Net Sales in accordance with the
provisions of Section 4.1.3.
3.11 INSPIRE Responsibilities
. INSPIRE will work collaboratively with ALLERGAN through the JCC
in connection with the marketing of Elestat in the Territory and,
in addition to the rights and responsibilities set forth elsewhere
in this Agreement, INSPIRE shall:
3.11.1 Use commercially reasonable
efforts to commercialize Elestat in the Territory. In connection
therewith, INSPIRE shall dedicate resources to the
commercialization of Elestat consistent with the resources that
INSPIRE, at all relevant times, would dedicate to products
containing compounds with similar commercial potential to Elestat
that were generated from INSPIRE’s own research efforts and
that INSPIRE decided to develop commercially and market.
3.11.2 Use commercially reasonable
efforts and proceed diligently to launch Elestat in the Territory
as soon as possible, and in no case later than forty-five (45) days
after the later of: (1) the first physical shipment of Elestat to
the trade by ALLERGAN; or (2) January 1, 2004; and to perform such
obligations by using, without limitation, a Sales Force with
sufficient skills and experience, together with sufficient
equipment and facilities.
3.11.3 INSPIRE shall, at its
expense, supervise, train and maintain such competent and qualified
sales representatives as may be required to promote and detail
Elestat as provided herein and in the Marketing Plans, such
training to include a reasonable proficiency examination for all
sales representatives who will be engaged in detailing. ALLERGAN
will provide reasonable assistance in the training at the launch
meeting and assimilation of training materials at its
expense.
14
[Note: Certain portions of this document have
been marked “[confidential treatment requested]” or
“[c.i.]” to indicate that confidentiality has been
requested for this confidential information. The portions have been
omitted and filed separately with the Securities and Exchange
Commission.]
3.11.4 INSPIRE shall use
commercially reasonable efforts to achieve at least fifty percent
(50%) of the applicable annual Net Sales forecast set forth on
Schedule B , provided there have been no material stock
outages (i.e., no backorders for Elestat over thirty (30) days in
any Commercial Year) during such period and subject to
ALLERGAN’s performance of its obligations under Section
3.9.2.
3.11.5 Commencing with the second
Calendar Quarter of 2004, INSPIRE shall furnish to ALLERGAN on or
before the forty-fifth (45th) day of each Calendar Quarter, a
summary of information coming to INSPIRE’s attention in the
Territory concerning introductions and promotional activities of
products competitive with Elestat.
3.11.6 Within thirty (30) days of
the Effective Date, and thereafter, by the seventh (7
th
) calendar day of each
month, INSPIRE shall provide ALLERGAN with a good faith eighteen
(18) month rolling forecast by month of estimated unit sales of
Elestat in the Territory, which forecast shall, for the avoidance
of doubt (and as applicable), update and supercede the forecast set
forth in the Marketing Plans.
3.11.7 At ALLERGAN’s request,
INSPIRE shall provide ALLERGAN with copies of any written
communications disseminated by INSPIRE generally to its Sales Force
relating to marketing and promotion strategy for
Elestat.
3.12 Shared Responsibilities
. The parties agree to share t