E XECUTION C OPY
EXHIBIT 10.163
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN REDACTED
AND HAVE BEEN FILED
SEPARATELY WITH THE U.S.
SECURITIES AND EXCHANGE COMMISSION
COPROMOTION AND MARKETING
SERVICES AGREEMENT
by and between
VALERA PHARMACEUTICALS,
INC.
and
INDEVUS PHARMACEUTICALS,
INC.
THIS COPROMOTION AND MARKETING
SERVICES AGREEMENT (the “ Agreement ”) is
made as of December 11, 2006 (“ Effective Date
”) by and between VALERA PHARMACEUTICALS, INC. , a
corporation organized and existing under the laws of the State of
Delaware and having its principal office at 7 Clarke Drive,
Cranbury, NJ 08512 (“ Valera” ) and INDEVUS
PHARMACEUTICALS, INC. , a corporation organized and existing
under the laws of the State of Delaware and having its principal
office at 33 Hayden Avenue, Lexington, MA 02421(“
Indevus ”).
W I T N E S S E T
H:
WHEREAS, the Parties desire that
Indevus engage in the Promotion (as hereinafter defined) of VANTAS
(as hereinafter defined) in the Territory (as hereinafter defined)
for a certain period of time and to coordinate Indevus’
activities with those of Valera, subject to the terms and
conditions of this Agreement;
NOW, THEREFORE, in consideration of
the foregoing statements and the mutual agreements and covenants
herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the
Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless specifically set forth to the
contrary herein, the following terms, where used in the singular or
plural, shall have the respective meanings set forth
below:
1.1 “ Act ” means
the United States Food, Drug, and Cosmetic Act of 1938, as amended,
and the rules and regulations promulgated thereunder, or any
successor act, as the same shall be in effect from time to
time.
1.2 “ Adverse
Experience ” or “ AE(s) ” means
adverse drug experiences, as defined by 21 CFR Section 314.80,
relating to a Product.
1.3 “ Affiliate ”
means (i) any corporation or business entity of which more
than fifty percent (50%) of the securities or other ownership
interests representing the equity, the voting stock or general
partnership interest are owned, controlled or held, directly or
indirectly, by a Party; or (ii) any corporation or business
entity which, directly or indirectly, owns, controls or holds more
than fifty percent (50%) (or the maximum ownership interest
permitted by law) of the securities or other ownership interests
representing the equity, the voting stock or, if applicable, the
general partnership interest, of a Party.
1.4 “ Business Day
” means any day that is not a Saturday or a Sunday or a day
on which the New York Stock Exchange is closed.
1.5 “ Calendar Quarter
” means each of the three month periods ending March 31,
June 30, September 30 and December 31, provided that
the first Calendar Quarter shall commence as of the Detail
Commencement Date and end on March 31, 2007.
1.6 “ Call ”
means a contact between a sales representative of a Party and a
Detail Target during which a Detail is made to the Detail
Target.
1.7 “ CFR ” means
the United States Code of Federal Regulations.
1.8 “ Claims ”
means any suits, claims, actions, demands, complaints, lawsuits or
other proceedings that are brought by any Third Party, including
without limitation product liability claims and claims seeking to
recover for personal injury or death that is alleged to have been
caused, in whole or in part, by a Product regardless of legal
theory.
1.9 “ Co-promotion
Option ” shall have the meaning set forth in
Section 2.2(a).
1.10 “ Current Good
Manufacturing Practices ” or “ GMP ”
or “ cGMP ” means the current good manufacturing
practice and standards as provided for (and as amended or updated
from time to time) in applicable ICH Harmonised Tripartite
Guidelines and as defined in Parts 210 and 211 of Title 21 of the
CFR, as may be amended from time to time, or any successors
thereto.
1.11 “ Committee
” means the committee described in
Section 3.1.
1.12 “ Deficient Half
Year ” means any Half Year during the Term in which the
total number of Units sold in such Half Year is greater than the
sum of the Quarterly Baseline Units applicable to the two Calendar
Quarters comprising such Half Year but less than the Minimum
Incremental Units applicable to such Half Year ; provided,
however , that in no event shall any Half Year be deemed a
Deficient Half Year if during any Calendar Quarter included in such
Half Year either (a) Valera did not satisfy its obligation to
provide the average number of representatives Detailing VANTAS
specified in Section 4.2(b)(i), or (b) there were any
shortages of Finished Product.
1.13 “ Detail ”
means a Call during which relevant characteristics of VANTAS are
described by the sales representative using, if necessary or
desirable, the Promotional Materials. When used as a verb,
“Detail” shall mean to engage in a Detail.
1.14 “ Detail Commencement
Date ” means the date that Valera receives written notice
from Indevus indicating that the first Call has been made by
Indevus’ sales representatives under the terms of this
Agreement.
1.15 “ Detail Targets
” means all office-based physicians and other health care
professionals in the Territory that influence the use of LHRH
agonists within a urologist office.
1.16 “ FDA ”
means the United States Food and Drug Administration and any
successor agency having substantially the same
functions.
1.17 “ Finished Product
” means the formulation of VANTAS described in the
specifications included in the NDA for VANTAS (the “
VANTAS Specifications ”) and packaged and labeled and
in a form ready for distribution in the Territory.
1.18 “ Forecast(s)
” has the meaning set forth in
Section 3.1(b)(viii).
-3-
1.19 “ Half Year
” means each of the six-month periods during the Term ending
on June 30 and December 31, provided that the first Half
Year shall commence as of the Detail Commencement Date and end on
June 30, 2007.
1.20 “ IND ”
means an Investigational New Drug application, as described in 21
C.F.R. Section 312.23, including all supplements and
amendments thereto.
1.21 “ Indevus
Trademark ” means the Indevus ® trademark and logo, which Indevus has
registered in the Patent Office, together with all related domain
names and other common law trademark rights related
thereto.
1.22 “ Losses ”
means any and all damages, awards, deficiencies, settlement
amounts, defaults, assessments, fines, dues, penalties (including
penalties imposed by any governmental authority), costs, fees,
liabilities, obligations, taxes, liens, losses, and expenses
(including court costs, interest and reasonable fees of attorneys,
accountants and other experts) awarded or otherwise paid or payable
to Third Parties.
1.23 “ Minimum Incremental
Units ” means, (a) for each Half Year during the
Term other than the first Half Year, the applicable number of Units
in excess of [*] Units, and (b) for the first Half Year
of the Term, the applicable number of Units in excess of [*]
Units, in each case as set forth on Schedule 1.23
.
1.24 “ NDA ”
means a new drug application as defined in the Act and applicable
regulations promulgated thereunder, as amended from time to
time.
1.25 “ Net Sales
” means the aggregate gross amount invoiced for all sales of
VANTAS to Third Parties in the Territory during the Term by Valera,
its Affiliates, and sublicensees commencing on the Detail
Commencement Date, less the following deductions actually allowed
or taken and not in excess of industry standard amounts and
determined in accordance with GAAP:
(a) credits or allowances actually
granted for damaged or spoiled Product, returns, recalls or
rejections of Product, and retroactive price reductions;
(b) normal and customary trade, cash
and quantity discounts, allowances and credits actually
allowed;
(c) sales, value added, excise or
similar taxes paid or allowed, or other governmental charges
imposed upon the importation, use or sale of Product in the
Territory;
(d) legally allowed chargebacks,
rebates or similar payments actually granted to customers,
including, but not limited to, managed health care organizations,
wholesalers, distributors, buying groups, retailers, health care
insurance carriers, pharmacy benefit management companies, health
maintenance organizations, Specialty Pharmacy Accounts or other
institutions or health care organizations or to federal,
state/provincial, local and other governments, their agencies and
purchasers and reimbursers; and
(e) credit card processing charges
and fees, freight, postage, shipping and insurance charges relating
to delivery of VANTAS.
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-4-
Sales or other transfers between
Valera and its Affiliates and/or sublicensees shall be excluded
from the computation of Net Sales and no payments will be payable
on such sales or transfers except where such Affiliates or
sublicensees are end users, but Net Sales shall include the
subsequent sales to Third Parties by such Affiliates or
sublicensees.
1.26 “ Option Period
” shall have the meaning set forth in
Section 2.2(a).
1.27 “ Party ”
means Indevus or Valera.
1.28 “ Patent Office
” means the United States Patent and Trademark
Office.
1.29 “ PDMA ”
means the United States Prescription Drug Marketing Act of 1987, as
amended, or any successor act thereto, and the regulations
promulgated thereunder from time to time.
1.30 “ Product ”
means VANTAS.
1.31 “ Product
Label(ing)” shall have the same meaning as defined in the
Act and as interpreted by the FDA.
1.32 “ Projected Detail
Commencement Date ” means [*] .
1.33 “ Promotion
” means those activities normally undertaken by a
pharmaceutical company to implement promotion plans and strategies
aimed at encouraging the appropriate use of a particular
prescription pharmaceutical product under a common trademark, up to
the point of offering Product for sale. When used as a verb,
“Promote” shall mean to engage in such
activities.
1.34 “ Promotional
Materials ” means all written, printed or graphic
material provided by Valera, intended for use by sales
representatives during a Call, including visual aids, file cards,
premium items, clinical studies, reprints, drug information updates
and any other promotional support items that Valera, following
consultation with the Committee, deems necessary or appropriate in
connection with the Promotion of Product. Promotional Materials
shall include materials describing FDA-approved indicated uses,
safety, effectiveness, contraindications, side effects, warnings
and other relevant characteristics of a Product. Promotional
Materials shall not include any Product packaging or Product
Labeling.
1.35 “ Promotion Budget
” means the budgets setting forth Promotion Expenses relating
to the Promotion of products, as described in
Section 3.1(b).
1.36 “ Promotion
Expenses ” means all actual out-of-pocket expenses
incurred (i.e., paid or accrued) to a Third Party by or on behalf
of Valera in connection with selling, marketing and Promotion of a
product in the Territory, including the following:
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-5-
(a) marketing, advertising,
Promoting, and educational expenses, including speakers’
programs, medical education programs and symposia, relationships
with opinion leaders and professional societies, public relations
and market research;
(b) training and communications
materials and detail and visual aids;
(c) implementing marketing programs;
and
(d) preparation, storage and
distribution of Promotional Materials;
provided, however
, that Promotion Expenses shall
specifically exclude salaries and other internal overhead and/or
compensation paid to either Party’s employees, including
their respective sales forces.
1.37 “ Promotion Plan
” means a plan established by Valera, with consultation of
the Committee, relating to the Promotion of a Product, as
contemplated by Section 3.1(b).
1.38 “ Proprietary
Information ” means any and all scientific, clinical,
regulatory, sales, marketing, financial and commercial information
or data, customer-related materials, know-how, concepts, ideas,
trade secrets, expertise, and all of the foregoing regardless of
whether communicated in writing, orally or by any other means,
which is owned and under the protection of one Party and is
provided by that Party to the other Party in connection with this
Agreement.
1.39 “ Quarterly
Payment ” means the payment made by Valera to Indevus of
its co-promotion fees owed at the end of each Calendar Quarter, in
accordance with the terms of Section 5.2(a).
1.40 “ Quarterly Baseline
Units ” means, (a) for each Calendar Quarter of the
Term other than the first Calendar Quarter of the Term, [*]
; and (b) for the first Calendar Quarter of the Term,
[*] .
1.41 “ SEC ”
means the Securities and Exchange Commission and any successor
agency having substantially the same functions.
1.42 “ Specialty Pharmacy
Accounts ” means those customers of Valera that, as a
pharmacy class, operate at any time during the Term according to
payer-specific contracts or product-specific distribution and
pharmacy programs. “ Specialty Pharmacy ” refers
to one of a specific group of pharmacies that either distribute
specialty medications, based upon a patient-specific prescription,
directly to patients, or to physicians for administration.
Valera’s Specialty Pharmacy Accounts as of the Effective Date
are listed on Schedule 1.42 .
1.43 “ Supprelin-LA
” means Valera’s hydrogel implant product designed to
deliver histrelin continuously for 12 months to treat central
precocious puberty, for which an NDA has been filed with the
FDA.
1.44“ Term ”
shall have the meaning set forth in Section 12.1.
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-6-
1.45 “ Territory
” means the United States of America, including the District
of Columbia, and its territories and possessions.
1.46 “ Third Party(ies)
” means a person or entity who or which is neither a Party
nor an Affiliate of a Party.
1.47 “ Unit ”
means one 12-month VANTAS implant.
1.48 “ Valera Patents
” means all patents and patent applications in the Territory
that are or become during the Term owned or controlled by Valera,
to the extent necessary or useful for the manufacture, Promotion,
use, sale and/or offer for sale of any Product, including any
patents, patent applications, certificates of invention, or
applications for certificates of invention and any supplemental
protection certificates, together with any extensions,
registrations, confirmations, reissues, substitutions, divisions,
continuations or continuations-in-part, reexaminations or renewals
thereof.
1.49 “ VALSTAR ”
means the VALSTAR brand of Valrubicin, intended for the treatment
of certain bladder cancer.
1.50 “ VANTAS ”
means Valera’s hydrogel implant product, marketed under the
brand name “VANTAS ® ”, designed to deliver histrelin
continuously for 12 months and indicated for the palliative
treatment of advanced prostate cancer. VANTAS is also concurrently
referred to herein as the “ Product
.”
1.51 “ VANTAS Trademark
” means the VANTAS ® trademark, which Valera has registered in the
Patent Office, together with all related domain names and other
common law trademark rights related thereto.
1.52 “ Year ”
means each consecutive twelve-month period starting January 1
and ending December 31, provided that the first Year of the
Term shall start on the Detail Commencement Date and end on
December 31, 2007.
Where words and phrases are used
herein in the singular, such usage is intended to include the
plural forms where appropriate to the context, and vice versa. The
words “including”, “includes” and
“such as” are used in their non-limiting sense and have
the same meaning as “including without limitation” and
“including but not limited to”. References to Articles,
Sections, subsections, and clauses are to the same with all their
subparts as they appear in this Agreement. “Herein”
means anywhere in this Agreement. “Hereunder” and
“hereto” means under or pursuant to any provision of
this Agreement.
ARTICLE 2
GRANT OF RIGHTS
2.1 Grant of Co-Promotion
Right . Subject to the terms and conditions of this Agreement,
Valera hereby grants to Indevus the co-exclusive right with Valera
during the Term to Promote VANTAS under the VANTAS Trademark in the
Territory, subject to the terms and conditions of this Agreement.
During the Term, neither Valera nor any Affiliate of Valera shall
sublicense or otherwise grant any Third Party any rights to
Promote, market, sell, or offer for sale VANTAS in the Territory
without Indevus’ prior written consent.
-7-
2.2 Grant of Option to Negotiate
Co-Promotion Right .
(a) Subject to the terms and
conditions of this Agreement, Indevus hereby grants Valera an
option (the “ Co-promotion Option ”),
exercisable at any time up to and through [*] , or such
other date as may be agreed to in writing by the Parties (the
“ Option Period ”), to elect to enter into
negotiations with Indevus to grant Indevus a co-exclusive right
with Valera to Promote VALSTAR and/or Supprelin-LA during the Term.
The Copromotion Option shall constitute a right but not an
obligation of Valera. In the event Valera elects to exercise the
Co-promotion Option, it shall send a written notice of such
election and of Valera’s proposed terms of such co-promotion
arrangement to Indevus, and the Parties shall enter into good faith
negotiations to enter into an additional co-promotion agreement,
containing such further commercially reasonable and customary
representations, warranties, covenants and agreements, satisfactory
in form and substance to the Parties and their legal advisors, as
are necessary or appropriate for transactions of this type and for
similar types of products.
(b) If as of the expiration of the
Option Period: (i) Indevus has not received the notice and
proposed terms from Valera, or (ii) the Parties have not
entered into any additional co-promotion agreement, each as
contemplated by paragraph (a) above, the Co-promotion Option
shall expire and terminate and neither Party shall have any further
rights or obligations with respect thereto.
2.3 Access to Information .
Subject to the terms and conditions of this Agreement, Valera shall
cooperate in good faith to provide Indevus access to and reasonable
assistance with all Valera Proprietary Information as may be
required for Indevus to exercise the rights granted and to perform
its obligations hereunder.
ARTICLE 3
GOVERNANCE
3.1 Committee .
(a) Members . The Parties
shall establish a committee comprised of four (4) individuals,
two (2) of which shall be appointed by Indevus and two
(2) of which shall be appointed by Valera (the “
Committee ”). The initial members of the Committee are
set forth on Schedule 3.1 . Either Party may replace any or
all of its representatives on the Committee at any time upon
written notice to the other. A Party may designate a substitute to
temporarily attend and perform the functions of such Party’s
designated representative at any meeting of the Committee. The
Chairman of the Committee shall be a representative of and
appointed by [*] and the secretary of the Committee shall be
a representative of and appointed by [*] .
(b) Role and Responsibilities
. The Committee will be used as the forum during the Term for the
Parties to discuss Promotion strategy, including pre-launch,
launch, post-launch and ongoing Promotional activities. The
Committee shall address these activities (i) during the Option
Period, with respect VANTAS, Valstar and Supprelin-LA, and
(ii) after expiration of the Option Period, solely with
respect to VANTAS. Accordingly, references in this
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-8-
Section 3.1(b) to ‘products’
shall mean the applicable product(s) as set forth in the preceding
sentence. In particular, subject to the foregoing and the other
terms and conditions of this Agreement, the Committee shall perform
the following functions:
(i) Discuss and advise Valera in
connection with the development of Promotion Plans and Promotion
Budgets (including allocation of Promotion Expenses within the
Promotion Budget on a quarterly basis for training, Promotional
Materials, visual aids and other Promotional activities intended to
support the Promotion and Detailing of such Product) for VANTAS,
and any material amendments or modifications to any Promotion Plan
or Promotion Budget, provided, however , that the Promotion
Budget for VANTAS shall be not less than (a) [*] for
the first Half Year, as allocated to the categories set forth on
the initial Promotion Budget for VANTAS ; and (b)
[*] for each Year thereafter.
(ii) Discuss the development of
Promotion Plans and Promotion Budgets for each of VALSTAR and
Supprelin-LA, provided, however, that such Promotion Budgets for
the Option Period shall be consistent with the levels of promotion
reasonably expected to be incurred by a company comparable in size
to Valera and in connection with the launch of products with
similar market potentials.
(iii) Discuss the actual results of
the Promotion of products in the Territory as compared to the
Promotion Plan;
(iv) Discuss the state of the
markets for products in the Territory and opportunities and issues
concerning the Promotion of products in the Territory, including
consideration of marketing, promotional and managed care strategy,
marketing research plans, labeling, product positioning and product
profile issues, to determine the kind of marketing and selling
efforts that are appropriate;
(v) Discuss the commercial terms and
conditions with respect to the sale and distribution of the
products;
(vi) Review data and reports
assembled by Valera from time to time with respect to the Promotion
of VANTAS in the Territory;
(vii) Review Promotional Materials
and promotional activities to be used by the Parties in the
Promotion of products, including the quantity, method of
distribution of, and guidelines for the use of Promotional
Materials or educational materials and literature related to
products;
(viii) Collaborate to develop annual
and quarterly forecasts (each, a “ Forecast ”)
for sales of the products; and
(ix) Have such other
responsibilities and address any other matters delegated to the
Committee under this Agreement or as may be mutually agreed upon in
writing by the Parties from time to time.
(c) Primary Contact . Indevus
and Valera each shall appoint a person (a “ Primary
Contact ”) to be the primary contact between the Parties
with respect to the Promotion
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-9-
Plan and to coordinate related correspondence
between the Parties. The initial Primary Contact is set forth on
Schedule 3.1. Each Party shall notify the other in writing
as soon as practicable upon changing its initial Primary Contact
appointment. The Primary Contact of each Party will be one of its
two representatives on the Committee.
3.2 Meetings . The chairman
of the Committee shall call meetings as reasonably requested during
the Term by one of the Parties upon not less than twenty-four hours
notice to each member of the Committee; provided ,
however , that (a) the agenda may be submitted by
either Party, and (b) the Committee shall meet on at least a
monthly basis during the period commencing on the Effective Date
and expiring at the end of the first Year of the Term (with the
first meeting to be held not later than five (5) Business Days
after the Effective Date) and thereafter on at least a quarterly
basis through the end of the Term, unless the Parties agree
otherwise. Meetings may be held in person, by telephone, or by
video conference call and, except as set forth herein, the location
of each meeting shall alternate between the Parties’ selected
locations in New Jersey or Massachusetts or such other location as
may be mutually agreed upon by the Parties. On advance written
notice to the other Party, additional participants may be invited
by any representative to attend meetings where appropriate and to
address any matters that are within the responsibilities and
functions of the Committee. Each Party shall be responsible for all
travel and related costs and expenses for its members and other
representatives to participate or attend committee meetings. Any
Proprietary Information disclosed in any meeting of the Committee
by a Party shall remain Proprietary Information of such
Party.
3.3 Minutes of Committee
Meetings . Minutes of the each committee meeting shall be
transcribed and issued by the secretary at least ten
(10) Business Days prior to the date of the next scheduled
meeting of such committee and shall be approved as the first order
of business at the immediately succeeding meeting of such
committee. Such minutes shall include only key discussion points
and decisions made and provide a list of any identified issues yet
to be resolved.
ARTICLE 4
PROMOTION AND MARKETING SERVICES
ACTIVITIES
4.1 General . Each Party will
diligently Promote VANTAS in the Territory during the Term, subject
to the terms and conditions of this Agreement and in accordance
with its business, legal, medical and scientific
judgment.
4.2 The following shall apply to the
Promotion of VANTAS under this Agreement:
(a) Indevus Obligations
.
(i) During the Term, Indevus will
provide a professional fully-trained sales force to support
Indevus’ obligations under this Agreement. During each
Calendar Quarter during the Term (commencing as of the Detail
Commencement Date), The Indevus Sales Force shall [*]
representatives Detailing VANTAS to Detail Targets. The Indevus
sales force shall remain under the direct and exclusive authority,
supervision and control of Indevus at all times during the
Term.
(ii) During the Term, the following
percentages of the annual bonus
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-10-
target (the payment of which shall be the sole
responsibility of Indevus) for the Indevus sales force Detailing
VANTAS will be directly related to VANTAS : (i) for the
first Year, at least [*] and (ii) for each subsequent
Year, at least [*]
(iii) During the Term, Indevus shall
fund “lunch and learn” programs for the representatives
Detailing VANTAS, to be held at the offices of Detail Targets, up
to a maximum of [*] (assuming a two Year Term, and subject
to pro-rata adjustment for any portion of the Term that is less
than two Years), which programs shall be excluded from the
Promotion Budget and shall be paid for by Indevus.
(b) Valera Obligations . In
addition to the services and other obligations of VALERA set forth
herein, Valera shall have the following obligations:
(i) During the Term, Valera will
provide a professional fully-trained sales force to support
Valera’s obligations under this Agreement. During each
Calendar Quarter of the Term (commencing as of the Detail
Commencement Date), The Valera Sales Force shall [*]
representatives Detailing VANTAS to Detail Targets. The Valera
sales force shall remain under the direct and exclusive authority,
supervision and control of Valera at all times during the
Term.
(ii) During the first Half Year of
the Term, at least [*] of the annual bonus target (the
payment of which shall be the sole responsibility of Valera) for
the Valera sales force Detailing VANTAS will be directly related to
VANTAS.
(iii) Valera shall be responsible
for payment of and shall pay all Promotion Expenses in accordance
with the then applicable Promotion Budget. Notwithstanding the
foregoing, in the event Valera does not incur Promotion Expenses at
least equal to the amount set forth in such Promotion Budget,
following written notice thereof and Valera’s failure to
incur the appropriate additional expenses to meet the applicable
Promotion Budget within ten (10) Business Days thereafter,
Indevus shall have the right, but not the obligation, to incur any
or all such Promotion Expenses (up to the budgeted amount) on
behalf of Valera and, in such event, Valera shall reimburse Indevus
for all such Promotion Expenses (up to the budgeted amount)
incurred by Indevus on behalf of Valera within thirty
(30) days of receiving an invoice therefor.
4.3 Failure to Meet Minimum
Incremental Units . In the event of a Deficient Half Year, the
Quarterly Payment for the Calendar Quarter ending concurrently with
such Deficient Half Year shall be reduced by an amount equal to the
product of (x), (y) and (z), where,
(x) =the difference between
(i) the applicable Minimum Incremental Units for such Half
Year, and (ii) the actual number of Units in excess of
[*] Units ( [*] Units for the first Half Year) that
are sold during such Half Year;
(y) =average net selling price per
Unit during such Half Year; and
(z) = [*]
If this calculation results in a
negative amount, such amount shall be carried forward to reduce
subsequent Quarterly Payments until such amount is depleted in its
entirety; provided, however, in the event a negative carry forward
remains upon the expiration or termination of this Agreement,
Indevus will not owe any amount to Valera.
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
-11-
4.4 Promotional Materials
.
(a) Valera shall provide Indevus
with Promotional Materials updated in accordance with
Section 4.4(c) and training materials for the performance and
supervision of Calls, by not later January 8, 2007, which the
Parties agree is necessary in order for Indevus to meet the
Projected Detail Commencement Date. Such Promotional Materials
shall be provided without cost to Indevus, and the cost shall be
part of the Annual Promotion Budget. Valera shall be solely
responsible for the preparation, content and method of distribution
of the Promotional Materials. Indevus’ representatives shall
use only the Promotional Materials provided by Valera in conducting
Calls hereunder and shall not develop, create, or use any other
promotional material or literature, or materials or other
promotional materials of any kind, for the Detailing of VANTAS.
Valera will coordinate with Indevus to replenish supplies of
Promotional Material when depleted on a timely basis. Valera shall
advise Indevus promptly of any inaccuracy or incompleteness of the
Promotional Materials, and upon such notice Indevus will advise its
representatives to cease the use of any portion or all of the
Promotional Materials so identified by Valera, and either destroy
or return such Promotional Materials to Valera, at Valera’s
instruction and expense and Valera shall furnish Indevus with
corrected or complete Promotional Materials as soon as practicable
thereafter. Valera shall be responsible for all submissions and
interactions with the FDA regarding approval of all Promotional
Materials that require FDA approval.
(b) Each of Valera and Indevus shall
retain all intellectual property rights, including without
limitation, all patents, copyrights and trademarks, to such
Party’s respective existing programs and materials in all
formats (print, video, audio, digital, computer, etc.) regarding
sales training, patient education and disease management programs
owned or controlled by such Party at the time such materials are
shared with the other Party, as well as any modifications of such
programs each may develop in the future which are not specific to
VANTAS.
(c) Except as otherwise prohibited
by applicable law and as otherwise set forth herein, all
Promotional Materials used during the Term, including journal
advertising and sales aids (excluding packaging and FDA approved
Product Labeling) shall display the names and logos of Valera and
Indevus. Except as otherwise prohibited by applicable law, and
further to the extent reasonably practicable, all Promotional
Materials will indicate that VANTAS is manufactured and sold by
Valera, and promoted by Indevus and Valera, and that the VANTAS
Trademark is owned by Valera, as directed by Valera.
Notwithstanding the foregoing, the Parties acknowledge and agree
that, to the extent Valera has backstock of existing Promotional
Materials, Valera shall be permitted to utilize such backstock, and
to provide such backstock to Indevus for use in connection with its
promotional efforts, prior to the development and distribution of
new Promotional Materials displaying the names and logos of both
Valera and Indevus. All applicable logos shall, subject to
compliance with applicable law, during the Term, be prominently
displayed in accordance with each Party’s specifications and
be of similar size to each other on all such materials. Each Party
hereby consents to such use of its name and logo, provided that the
other Party adheres to the agreed-on format and language, and
provided further that neither Party will acquire any rights in the
other Party’s name or logo. After expiration of the Term or
termination of this Agreement, neither Party will include the
other’s name or logo on any Promotional Materials, except as
required by law.
-12-
4.5 Training .
(a) Each Party shall have the
responsibility for training such Party’s sales force with
respect to Promotion of VANTAS in the Territory, and each Party
will be solely responsible for all costs associated with training
its respective sales force. During the Term, Valera shall provide
Indevus with such assistance as is reasonably requested by Indevus
and as mutually agreed to in connection with the training programs
to help ensure that the training of Indevus’ sales force will
be consistent with the training provided to Valera’s sales
force who Detail VANTAS in the Territory.
(b) During the Term, Valera shall
provide Indevus with sufficient quantities of training materials
relating to VANTAS in order to meet the Projected Detail
Commencement Date, including an up-to-date programmed learning unit
for VANTAS for “at home” study. Such materials shall be
provided to Indevus free of charge for distribution to the Indevus
sales force, and all costs associated with the preparation and
distribution of training materials shall be deemed Promotion
Expense and the cost counted toward the Annual Promotion
Budget.
(c) All expenses incurred by either
Party associated with any launch meeting or any training meetings
for VANTAS for such Party’s sales force during the Term shall
be the responsibility of the Party incurring such cost. Promptly
after the Effective Date, Valera and Indevus shall agree on a
mutually convenient schedule which will enable the training of the
Indevus sales force in sufficient time to meet the Projected Detail
Commencement Date.
(d) In addition to the training
referred to above, during the Term, each Party shall conduct
separate training programs for their respective sales force with
respect to the “Medicare and Medicaid Anti-Kickback
Statute”, set forth at 42 U.S.C. §1320(a)-7b(b) and the
prohibited acts set forth thereunder, PDMA regulations, and other
applicable guidances relating to promotion of Product. Upon
completion of said additional training, each sales force member
shall be required to sign a certificate acknowledging their receipt
of such training and certifying and acknowledging their
understanding of said statutes and the specified acts prohibited
thereunder.
4.6 Other Marketing and Promotion
Services .
(a) Valera shall provide such other
Promotional activities, as applicable, which are an integral part
of the implementation of Promotion plans to support the activities
normally undertaken by a professional sales representative of a
pharmaceutical company comparable in size to Indevus and Valera to
Promote a particular prescription pharmaceutical product aimed at
encouraging the appropriate use of such product by a health care
professional with actual prescribing authority or influence or, in
the case of VALSTAR and Supprelin-LA, to prepare for such
activities. Valera shall incur Promotional Expenses up to the
amount set forth in the applicable Promotion Budgets. Valera shall
be responsible for payment on a timely basis of all Promotion
Expenses set forth in the Promotion Budgets in accordance with such
budgets.
-13-
(b) Valera or its Third Party
contractor shall provide reasonable order entry, customer service,
reimbursement management, medical affairs (including reports for
all Adverse Experiences as set forth in Article 6), medical
information, warehousing, physical distribution, invoicing, credit
and collections (including maintaining and enforcing the credit
policy applicable to VANTAS), production forecasting and other
related facilities and services necessary or desirable for the
manufacturing and supply, distribution, marketing, Promotion and
sales of VANTAS under this Agreement. Such services shall include
contract administration, including handling wholesaler chargebacks,
managed care contracts, federal and state government contracts,
rebate contracts, long-term care contracts, performance-based
contracts, Specialty Pharmacy contracts and hospital purchasing
contracts. Valera shall book all sales and be exclusively
responsible for accepting and filling purchase orders for Product
and for processing billing and returns with respect to the
Products.
(c) Valera will use reasonable
efforts to (i) provide Indevus with reasonable access to all
medical advisors and consultants and with medical education and
public relations agencies engaged by Valer
