[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act Of 1933, as amended.
COLLABORATION AND
COMMERCIALIZATION AGREEMENT
This Collaboration and
Commercialization Agreement (the
“Agreement” ) is entered into as of
February 10, 2006 (the “Effective
Date” ) by and among Replidyne, Inc. , a Delaware
corporation ( “Replidyne” ), having its
principal place of business at 1450 Infinite Drive, Louisville,
Colorado 80027, and Forest Laboratories Holdings
Limited , an Irish corporation (
“Forest” ), having its principal place of
business at Milner House, 18 Parliament Street, Hamilton HM11,
Bermuda.
Whereas ,
Replidyne and Daiichi Asubio Pharmaceutical, Inc. (
“DAP” ) (successor-in-interest to
Daiichi Suntory Pharma Co., Ltd.) entered into a License Agreement
dated March 15, 2004 as may be amended in accordance with its
terms (the “DAP Agreement” ), pursuant to
which DAP granted to Replidyne an exclusive license to certain
patents and know-how to develop and commercialize faropenem
medoxomil (formerly designated as faropenem daloxate) in the Field
(as defined below) in specified countries;
Whereas,
Forest develops, manufactures and markets pharmaceutical products,
and in particular, has expertise in promoting pharmaceutical
products to primary care physicians;
Whereas,
Replidyne develops anti-infective and other pharmaceutical products
and is building an organization to promote pharmaceutical products
to specialist physicians;
Whereas,
Forest and Replidyne desire to collaborate on the further
development of faropenem medoxomil for the treatment of
community-acquired infectious diseases in the Territory (as defined
below), with the intent that Forest will market and promote the
product(s) primarily to primary care physicians, and Replidyne will
market and promote the product(s) primarily to certain medical
specialists, including pediatricians;
Whereas,
Forest desires to acquire, and Replidyne is willing to grant to
Forest, certain licenses under patents and know-how controlled by
Replidyne to develop and commercialize faropenem medoxomil in the
Field in the Territory (as defined below), in accordance with
foregoing and the terms and conditions set forth in this
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 “ADEs” has the meaning provided in
Section 5.12.
1.2 “Administrator” has the meaning
provided in Section 14.2 .
1.
1.3 “Affiliate” means any company or
entity controlled by, controlling, or under common control with a
party hereto. For this purpose, the term “control”
shall mean the direct or indirect ownership of more than 50% of the
voting stock or other ownership interests of that entity, or the
power, directly or indirectly to cause the direction of the
management and policies of such entity.
1.4 “AECB Indication” means a separate,
labeled use for the treatment of acute exacerbations of chronic
bronchitis in humans.
1.5 “ANDA” shall mean an Abbreviated New
Drug Application filed with the FDA (as more fully defined in 21
USC §355(j)).
1.6 “ANDA Proceeding” has the meaning
provided in Section 9.4(b) .
1.7 “AOM Indication” means a separate,
labeled use for the treatment of acute otitis media in
humans.
1.8 “API Supply Agreement” means the
agreement setting forth the terms and conditions for the supply of
Drug Substance from NISSO through DAP to Replidyne dated
December 20, 2004, as the same may be amended or assigned to
Forest as contemplated in Section 6.2
hereof.
1.9 “Applicable Laws” means all
applicable laws, rules and regulations that apply to the
development, manufacturing or commercialization of Product in the
Territory or the performance of either party’s obligations
under this Agreement, including without limitation any rules,
regulations, guidelines or other requirements of the FDA, that may
be in effect from time to time.
1.10 “Arbitrators” has the meaning
provided in Section 14.2 .
1.11 “Bayer” means Bayer AG, a prior
licensee of the DAP Know-How and DAP Patents pursuant to a license
agreement with Suntory Ltd., Tokyo, Japan, a predecessor in
interest to DAP, dated June 28, 1999, which was terminated
November 19, 2003.
1.12 “Bayer Know-How” means the data,
information, documentation, know-how and technology, relating to
Drug Substance and/or Products that was generated or acquired by
Bayer and/or its Affiliates and actually provided to Replidyne by
DAP.
1.13 “Calendar Quarter” means each
respective period of three (3) consecutive months ending on
March 31, June 30, September 30 and
December 31.
1.14 “Canadian Rights” has the meaning
provided in Section 5.9(b) .
1.15 “Ciba-Geigy Patents” means the
patents owned by Ciba-Geigy (currently Novartis) as listed in
Exhibit A hereof.
1.16 “Claim” has the meaning provided in
Section 14.2 .
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
2.
1.17 “ [ *** ] Threshold” has the
meaning provided in Section 7.3(d) .
1.18 “Combination Product” means a
Product containing one or more other therapeutically active
ingredients in addition to the Drug Substance.
1.19 “Commercially Reasonable Efforts”
means, with respect to the development or commercialization of the
Product, except as otherwise explicitly set forth in this
Agreement, the level of efforts required to carry out such
obligation in a sustained manner consistent with the efforts a
biotechnology company or pharmaceutical company, as the case may
be, devotes to a product of similar market potential, profit
potential or strategic value resulting from its own research
efforts, based on market conditions then prevailing, consistent
with the exercise of prudent scientific and/or business judgment in
accordance with generally accepted practices in the pharmaceutical
industry. Commercially Reasonable Efforts shall be determined
without regard to the particular circumstances of a party,
including any other product opportunities of such party.
Commercially Reasonable Efforts requires, with respect to such an
obligation, that the party: (a) promptly assign responsibility for
such obligation to specific employee(s) who are held accountable
for progress and monitor such progress on an on-going basis;
(b) set and consistently seek to achieve specific, meaningful
and measurable objectives for carrying out such obligation; and (c)
consistently make and implement decisions and allocate resources
designed to advance progress with respect to such objectives. The
term “commercially reasonable” has the corresponding
meaning.
1.20 “Competitive Product” has the
meaning set forth in Section 5.10.
1.21 “Confidential Information” has the
meaning provided in Section 11.1 .
1.22 “Control” means, with respect to any
information, Patent or other intellectual property right,
possession by a party of the ability (whether by ownership, license
or otherwise) to grant access, a license or a sublicense to such
information, Patent or intellectual property right without
violating the terms of any agreement or other arrangement with any
Third Party.
1.23 “Cost of Goods” for any dosage
strength and formulation of the Product for any period shall mean
actual direct out-of-pocket cost incurred by a party for the
acquisition of Drug Substance and actual direct out-of-pocket costs
incurred by a party for the acquisition, manufacture, shipping from
the manufacturer to Forest’s initial distribution site,
storage at such site, and final labeling and packaging of the
Product for such period, including the cost of commercially
reasonable strategies for hedging of exchange rate risk (in each
case, to the extent not already deducted in the calculation of Net
Sales or included in Distribution Costs), as recognized and
recorded in accordance with US GAAP.
1.24 “Cost of Goods Committee” or
“CGC” means the committee formed pursuant
to Section 3.3 .
1.25 “DAP Improvement” means any and all
developments, enhancements, modifications, inventions or
discoveries in the Field relating to Products for use in the Field,
that are developed or created by or on behalf of DAP (other than by
Replidyne, its Affiliates, licensees and sublicensees, and their
respective employees, agents, consultants,
subcontractors
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
3.
and other
representatives) at any time during the term of the DAP Agreement,
whether patentable or not, including but not limited to,
developments, inventions or discoveries intended to enhance the
safety or efficacy of Drug Substance and/or Products, and all
intellectual property rights thereto which are necessary or useful
for Forest to exercise the rights licensed to it under
Section 2.1 of this Agreement, but excluding those
related specifically to manufacturing of Drug Substance.
1.26 “DAP Know-How” means any and all
data, information, documentation, know-how and technology, whether
patentable or not, relating to Drug Substance and/or Products,
including, without limitation, information regarding their
stability, pharmacology, toxicology, clinical use, compositions and
formulations for administration, and any scientific information and
data developed by Wyeth relating to Drug Substance and to Products;
in each case that was generated or acquired by DAP and/or its
Affiliates prior to the effective date of the DAP Agreement or is
generated by DAP and/or its Affiliates during the term of the DAP
Agreement, but excluding data, information, documentation, know-how
and technology, whether patentable or not, related specifically to
manufacturing of Drug Substance.
1.27 “DAP Logogram” means the logogram
adopted by DAP at any time during the term of the DAP
Agreement.
1.28 “DAP Patents” means the patent
applications and patents listed in Exhibit B
attached hereto, and patents issuing from such patent applications,
and any and all patents and patent applications covering DAP
Improvements, in each case including any continuations,
continuations-in-part, provisionals, divisionals, reissues,
reexaminations, extensions, substitutions, restorations, additions,
revalidations, registrations, confirmations, renewals and
counterparts thereof in the Territory that are necessary or useful
for the use, development, manufacture, marketing, promotion,
distribution, sale and/or commercialization of Products in the
Territory for use in the Field.
1.29 “Detail” means an interactive
face-to-face contact of a sales representative, who is fully
equipped with, and knowledgeable of, applicable promotional
materials and product labeling for the Product, with a target
physician or other medical professional licensed to prescribe drugs
or other healthcare professional that has a significant impact or
influence on prescribing decisions, during which relevant
characteristics of the Product are described by the sales
representative. Details shall be deemed to include only
presentations in the first or second position in a sales
presentation and shall not be deemed to include
“tertiary” or “reminder” details, in each
case as such terms are generally understood in the pharmaceutical
industry. “Detailing” shall have a
corresponding meaning.
1.30 “Detailing Commencement Date” means
the first day following NDA Approval on which Detailing of the
Product by Replidyne begins, as determined by the JMC.
1.31 “Detailing Year” means, with respect
to the first Detailing Year, the twelve (12) month period
commencing on the Detailing Commencement Date, and with respect to
subsequent Detailing Years, each successive twelve (12) month
period thereafter.
1.32 “Detail Reports” means a report of
Details performed by a party during the
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
4.
Calendar
Quarter covered by such statement containing such information and
in such format as determined by the JMC.
1.33 “Development Costs” means with
respect to a particular Product the sum of all internal costs,
including to the extent allocated to the foregoing directly related
overhead (but not general or corporate overhead), and direct
out-of-pocket costs, in each case incurred by a party and/or its
Affiliates in connection with the conduct of the activities
assigned to it by the JDC pursuant to the Development Plan,
including, without limitation, FTE costs (which fairly reflect the
actual FTE costs of each party for its personnel in the applicable
functional areas (but excluding senior executives), to be discussed
and agreed upon by the parties respective finance departments),
costs of preparation of regulatory filings, costs of clinical
supply of Product, and any other activities conducted under the
Development Plan that support obtaining or maintaining NDA Approval
of Product in the Territory, such as surveillance studies and
pharmacovigilance. Development Costs shall be determined in
accordance with US GAAP and in accordance with the relevant
party’s accounting standards applied on a consistent
basis.
1.34 “Development Information” means any
and all information generated by a party (or a party’s
Affiliates or any Third Party on behalf of a party) in the
development of the Drug Substance and/or Product for the Territory
as provided in this Agreement, including, without limitation,
protocols, analysis plans, annotated case report forms per study,
analysis datasets, programs, raw data and other relevant
documentation used for the study reporting efforts, FDA outputs
relating to the development of, and/or filing of NDAs for, Drug
Substance and/or Product in the Territory (including, without
limitation, all substantive correspondence with the FDA, responses
from the FDA, requests for information from the FDA, briefing
documents and other materials relating to interactions with the
FDA, and summaries of outputs resulting from substantive
correspondence/ conversations or meetings with the FDA), and
information from clinical advisory boards and
investigators.
1.35 “Development Plan” means the plan
and related budget for conducting research and development of the
Drug Substance and Products in the Field in the Territory, as
amended from time to time by the JDC. The initial outline of the
Development Plan has been agreed upon by the parties in writing as
of the Effective Date.
1.36 “Development Program” means a
research and development program carried out by Replidyne and, as
applicable, Forest pursuant to Article 4 , as more
fully described in the Development Plan.
1.37 “Distribution Costs” for any dosage
strength and formulation of the Product for any period shall mean a
reasonable estimate of the direct out-of-pocket costs of shipping,
handling and other Product-specific logistical costs, including,
without limitation, quality assurance and quality control
procedures and regulatory reporting obligations, related to
distribution of the Product from Forest’s initial
distribution site to Forest’s customers (to the extent not
already deducted in the calculation of Net Sales or included in
Costs of Goods) as recognized and recorded in accordance with US
GAAP. The parties’ finance departments will mutually agree
upon a simple rule for Distribution Costs (e.g., as a percentage of
Net Sales) after mutual review and discussion of Forest’s
actual Distribution Costs from time to time.
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
5.
1.38 “Drug Substance” means the chemical
substance identified as faropenem medoxomil as its generic name
(formerly designated as faropenem daloxate) and having the chemical
structure: (5-Methyl-2-oxo-1, 3-dioxolen-4-yl) methyl (5R,
6S)-6-[(R)-1-hydroxyethyl]-2-[(R)-2-tetrahydro-furyl]
penem-3-carboxylate.
1.39 “FDA” means the United States Food
and Drug Administration, or any successor agency thereto having the
administrative authority to regulate the marketing of human
pharmaceutical products or biological therapeutic products,
delivery systems and devices in the United States of
America.
1.40 “Field” means the treatment,
amelioration or prevention of infectious diseases in humans and all
other pharmaceutical uses and indications for the
Product.
1.41 “First Commercial Sale” means, with
respect to any Product, the first sale for end use or consumption
of such Product in the United States after NDA Approval. Sale to an
Affiliate or sublicensee shall not constitute a First Commercial
Sale unless the Affiliate or sublicensee is the end user of the
Product.
1.42 “Forest Costs” has the meaning
provided in Section 7.3(d) .
1.43 “Forest Indemnitee” has the meaning
provided in Section 13.1 .
1.44 “Forest Inventions” has the meaning
provided in Section 9.1 .
1.45 “Forest Know-How” means any and all
data, information, documentation, know-how and technology
Controlled by Forest or any of its Affiliates on the Effective Date
or during the Term that is useful for purposes of the Development
Program or necessary or useful for the manufacture of Product
(including Drug Substance) anywhere in the world, or the
commercialization or use of the Drug Substance or Product in the
Field in the Territory, including, without limitation, all such
data, information, documentation, know-how and technology that is
developed or acquired by Forest or any of its Affiliates in the
course of performance of, or pursuant to any right granted under,
this Agreement, but excluding the Forest Patents and the Joint
Patents.
1.46 “Forest Patents” means all Patents
Controlled by Forest or any of its Affiliates on the Effective Date
or during the Term to the extent useful for purposes of the
Development Program or necessary or useful for the manufacture of
Product (including Drug Substance) anywhere in the world, or the
commercialization or use of the Drug Substance or Product in the
Field in the Territory, including, without limitation, any Patents
that claim or disclose any Forest Invention, but excluding the
Joint Patents.
1.47 “Forest Sales Force” means those
members of Forest’s sales force (whether Forest employees,
contractors or agents), who promote Product in the Field in the
Territory, but excluding the Replidyne Pediatrician Sales Force and
Replidyne Specialty Sales Force, together with field-based sales
managerial personnel having direct and sole responsibility for the
management of such sales force.
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
6.
1.48 “Forest Technology” means the Forest
Patents and Forest Know-How.
1.49 “FTE” means the equivalent of the
work time of an employee or consultant of Replidyne or Forest (or
their Affiliates, as applicable) with appropriate qualifications
performing work under the Development Plan on a full-time basis
over a 12-month period (including normal vacations, sick days and
holidays).
1.50 “Generic Equivalent” shall mean, on
a Product-by-Product basis, a product that is therapeutically
equivalent to a Product and that: (a) is pharmaceutically
equivalent to such Product (contains the same active ingredient(s)
and has the same dosage form, route of administration and
strength); and (b) has gained market approval through an ANDA
filed in accordance with 505(j) of the U.S. Food Drug &
Cosmetic Act and prepared in accordance with 21 CFR 314.94 or
through any equivalent mechanism under any successor law or
regulation in the United States.
1.51 “Generic Profits” shall mean, with
respect to a generic Product sold by Forest, its Affiliates or
permitted sublicensees, on a Product-by-Product basis, an amount,
which shall not be less than zero (0) for purposes of this
Agreement, equal to (a) Net Sales of such generic Product,
minus (b) Cost of Goods, Distribution Costs and sales and
marketing costs (such as trade advertising) of Forest for such
generic Product in the Territory.
1.52 “IND” means an Investigational New
Drug Application filed with the FDA, or the equivalent application
or filing filed with any equivalent agency or governmental
authority outside the United States of America (including any
supra-national agency such as in the European Union) necessary to
commence human clinical trials in such jurisdiction.
1.53 “Initial Period” means the first
[ *** ] months of the Replidyne Specialist Promotion
Period.
1.54 “Inventions” has the meaning
provided in Section 9.1 .
1.55 “Joint Development Committee” or
“JDC” means the committee formed pursuant
to Section 3.1 .
1.56 “Joint Inventions” has the meaning
provided in Section 9.1 .
1.57 “Joint Marketing Committee” or
“JMC” means the committee formed pursuant
to Section 3.2 .
1.58 “Joint Patents” means all Patents in
the Territory that claim or disclose a Joint Invention.
1.59 “Joint Supply Committee” or
“JSC” means the committee formed pursuant
to Section 6.1 .
1.60 “Licensed Know-How” means any and
all data, information, documentation, know-how and technology
Controlled by Replidyne as of the Effective Date or during the Term
that is useful for purposes of the Development Program or necessary
or useful for the
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
7.
manufacture of
Product (including Drug Substance) anywhere in the world
(excluding, with respect to the DAP Know-How, rights in Japan,
except to the extent rights in Japan are included in the rights
granted to Replidyne under the DAP Agreement), or the
commercialization or use of Drug Substance or Product in the Field
in the Territory, including, without limitation, the DAP Know-How
and the Bayer Know-How, but excluding the Licensed Patents and the
Joint Patents.
1.61 “Licensed Patents” means the
Replidyne Patents, the Ciba-Geigy Patents and the DAP
Patents.
1.62 “Licensed Technology” means the
Licensed Patents and Licensed Know-How.
1.63 “Losses” has the meaning provided in
Section 13.1 .
1.64 “Manufacturing Technology” means all
information and documentation necessary or advisable to enable
Replidyne or its designee to manufacture Drug Substance, including
without limitation, NISSO’s standard operating procedures,
NISSO’s Improvements, and the Drug Master File sections
relevant to chemical manufacturing, testing and release, Sensitive
Manufacturing Information, and all updates thereto.
(a) “NISSO’s Improvements”
means all information, documents and tangible and intangible
materials which result from or are related to the performance by
NISSO of the services contemplated by the API Supply Agreement
(including, without limitation, data, test results, measurements,
quantitative and qualitative analyses, processes, samples,
inventions, discoveries, improvements, intellectual property,
derivative works, technology and/or any other work product, whether
patentable or not) developed under the API Supply Agreement by
NISSO or on behalf of NISSO by any of its representatives relating
to the Drug Substance or the Products.
(b) “Drug Master File” means the
drug master file, as defined in 21 CFR Section 314.420 or
successor provision, filed with the FDA with respect to the Drug
Substance, which permits NISSO to authorize others to rely on the
information in such file to support an NDA for the
Products.
(c) “Sensitive Manufacturing
Information” means the confidential manufacturing
information that is included in the Drug Master File.
1.65 “Marketing and Sample Expense”
means, generally, the external, out-of-pocket costs which are
incurred by a party or for its account attributable to the
marketing of any dosage strength and formulation of the Product in
the Territory, including, without limitation, the sum of
Advertising, Consumer and Physician Promotion, Education, Market
and Consumer Research, Phase IV Programs, Promotional Management
and Trade Promotion Expenses, each of which is specified below. To
the extent multiple products are involved and some of such products
are not Product, then such expenses will be allocated on a pro rata
basis based upon net sales of each respective product by such party
during the most recent Calendar Quarter. The costs of activities
which promote a party’s business as a whole without being
product specific (such as corporate image advertising) are
specifically excluded from Marketing and Sample Expense.
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
8.
(a) “Advertising” means all media
costs associated with advertising the Product in the Territory
including, but not limited to the following: production
expense/artwork including set up; design and art work for an
advertisement; advertising agency fees; the cost of securing print
space, air time and the like in newspapers, magazines, trade
journals, television, radio, billboards and other media.
(b) “Consumer and Physician
Promotion” means the expenses associated with
programs to promote the Product in the Territory directly to the
prescriber or end user, including, but not limited to, expenses
associated with promoting products directly to the professional
community such as professional samples (including Cost of Goods of
samples), professional literature, promotional material costs,
patient aids and detailing aids.
(c) “Education” means expenses
associated with professional education with respect to the Product
in the Territory through any means not covered under subsections
(a) and (b) above, including, but not limited to,
articles appearing in journals, newspapers, magazines or other
media; seminars, lunch and dinner programs, CME programs and
professional society programs, scientific exhibits, and
conventions; and symposia, advisory boards and opinion leader
development activities.
(d) “Market and Consumer Research”
means payments to Third Parties related to conducting and
monitoring professional and consumer appraisals of existing, new or
proposed Product in the Territory, such as market share services
(e.g., IMS data), special research testing, focus groups, as well
as qualitative and quantitative research studies.
(e) “Phase IV Programs” means
payments to Third Parties and the directly allocable internal costs
of a party (including directly related overhead but not corporate
or general overhead) for functions (such as data collection and
analysis) that a party performs internally on a reasonably
cost-effective basis compared to Third Party costs for such
functions, in each case for Phase IV marketing studies of the
Product in the Territory, including, but not limited to, the cost
of clinical grants and the cost of clinical research
organizations.
(f) “Promotional Management” means
payments to Third Parties for development or management of
marketing or promotional strategies, planning and programs for the
Product in the Territory, including, but not limited to, costs
associated with developing overall sales and marketing strategies
(e.g., product line or customer segment), and planning and programs
for the Product in the Territory, including, but not limited to,
launch sales force meetings, promotional meetings, other meetings
scheduled solely for the Product (but not periodic sales force
meetings of a party), conventions and seminars. In addition,
payments to Third Parties in connection with Trademark selection,
filing, prosecution and enforcement in the Territory are included
in this category.
(g) “Trade Promotion” means the
allowances given to retailers, brokers, distributors, hospital
buying groups and similar groups for purchasing, promoting, and
distribution of the Product in the Territory, including, but not
limited to, purchasing, advertising, new distribution, and display
allowances as well as free goods, wholesale allowances and
reasonable field sales samples (to the extent not already deducted
in the calculation of Net Sales).
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
9.
1.66 “Marketing Expense Ratio” has the
meaning set forth in Section 5.3(e) .
1.67 “Marketing Plan” means the annual
marketing and commercial plan for the Product in the Field in the
Territory that includes the related budget for Marketing and Sample
Expense, as the same is from time to time in effect in accordance
with the terms hereof.
1.68 “NDA” means a New Drug Application
(as more fully defined in 21 C.F.R. 314.5 et seq. ) and all
amendments and supplements thereto filed with the FDA, including
all documents, data, and other information concerning a
pharmaceutical product which are necessary for gaining approval to
market such pharmaceutical product in the United States.
1.69 “NDA Acceptance” means the
submission of a NDA for Product to the FDA and filing of such NDA
by the FDA.
1.70 “NDA Approval” means the issuance by
the FDA of an action letter indicating that an NDA for Product is
approved. For avoidance of doubt, NDA Approval does not mean that
the FDA issues an action letter indicating that an NDA for Product
is approvable.
1.71 “Net Sales” means, for the
applicable period, the gross amount invoiced for sales or other
transfers of the Products (including, for purposes of
Section 7.5 , any generic Product) by Forest and its
Affiliates and permitted sublicensees to Third Parties that are not
Affiliates or permitted sublicensees of Forest (and to any
Affiliate or sublicensee of Forest if such Affiliate or sublicensee
is the final user of and does not further sell such Product, in
which case the amount billed therefor shall be deemed to be the
amount that would be billed to an independent Third Party in an
arm’s length transaction), less the following items as
allocable to such Products, all as recorded in accordance with US
GAAP and in a manner consistent with Forest’s revenue
recognition policies from the sale of pharmaceutical products
consistently applied:
(a) trade discounts, credits or allowances, including
without limitation, discounts provided by means of chargebacks,
rebates and administrative fees charged by customers or health care
organizations determined based upon sales;
(b) credits or allowances additionally granted upon
returns, rejections or recalls (except where any such recall arises
out of Forest’s or its Affiliate’s gross negligence,
willful misconduct or fraud);
(c) freight, shipping and insurance
charges;
(d) taxes, duties or other governmental tariffs (other
than income taxes); and
(e) rebates, discounts or other payments on sales of
Product that are mandated by the government.
In
the case of the Combination Products, the Net Sales shall be
calculated by multiplying actual Net Sales of the Combination
Product (calculated as if such Combination Product did not contain
other therapeutically active ingredients) by the fraction A/(A+B)
where A is the invoice price of a Product containing only Drug
Substance, if sold separately, and B is the total invoice price of
the other active ingredient or ingredients in the combination, if
sold separately. If the
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
10.
other active
ingredient or ingredients in the Combination Product are not sold
separately in the Territory, Net Sales shall be calculated by
multiplying actual Net Sales thereof by the fraction A/C where A is
the invoice price of a Product containing only Drug Substance, if
sold separately, and C is the invoice price of the Combination
Product.
If
the Product containing only Drug Substance is not sold separately
in the Territory, the parties shall, in good faith, negotiate and
agree upon how to calculate the Net Sales on sales of the
Combination Product, with a view to achieving to the greatest
extent possible the economic balance and mutual understanding
established between the parties for calculation of Net Sales on the
Combination Product as reflected in this section.
1.72 “NISSO” means Nippon Soda Co., Ltd.,
which is the contract manufacturer of the Drug Substance for
Replidyne as of the Effective Date.
1.73 “Oral Suspension” means a finished
pharmaceutical preparation containing the Drug Substance as an
active ingredient, consisting of a dosage formulation of the Drug
Substance suspended in a liquid for delivery by mouth.
1.74 “Patents” means: (a) an
unexpired patent which has not been held invalid or unenforceable
by a court of competent jurisdiction from which no appeal can be
taken or has been taken within the required time period, including
without limitation any substitution, extension, registration,
confirmation, reissue, re-examination, renewal or any like filing
thereof; and (b) pending patent applications, including without
limitation any provisional, converted provisional, continued
prosecution application, continuation, divisional or
continuation-in-part thereof.
1.75 “Pediatrician” means a physician
specializing in the development, care, and treatment of children
from birth through adolescence and board certified in
pediatrics.
1.76 “Pediatrician Promotion Option” has
the meaning set forth in Section 5.5.
1.77 “Pediatrician Promotion Rights” has
the meaning set forth in Section 5.5 , as further
described in Schedule 5.5 .
1.78 “Phase 2 Clinical Trial” means a
human clinical trial that would satisfy the requirements for a
Phase 2 study as defined in 21 C.F.R. 312.21(b) (or its successor
regulation).
1.79 “Phase 3 Clinical Trial” means a
human clinical trial that would satisfy the requirements for a
Phase 3 study as defined in 21 C.F.R. 312.21(c) (or its successor
regulation).
1.80 “Pre-Launch Period” means, with
respect to a Product, the twelve (12) month period preceding
the anticipated Detailing Commencement Date for such
Product.
1.81 “Primary Care Physician” or
“PCP” means a physician, such as a
general practitioner or internist, chosen by an individual to serve
as his or her health-care professional and capable of handling a
variety of health-related problems, of keeping a medical history
and medical records on the individual, and of referring the person
to Specialists as needed.
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
11.
1.82 “Product” means a finished
pharmaceutical preparation containing the Drug Substance as an
active ingredient, in any dosage or formulation, including but not
limited to a Tablet or an Oral Suspension.
1.83 “Replidyne Indemnitee” has the
meaning provided in Section 13.2 .
1.84 “Replidyne Inventions” has the
meaning provided in Section 9.1 .
1.85 “Replidyne Patents” means all
Patents Controlled by Replidyne as of the Effective Date or during
the Term that are useful for purposes of the Development Program or
necessary or useful for the manufacture of Product (including Drug
Substance) anywhere in the world, or the commercialization or use
of Drug Substance or Product in the Field in the Territory,
including, without limitation, any Patents that claim or disclose
any Replidyne Invention, but excluding the Ciba-Geigy Patents, the
DAP Patents and the Joint Patents.
1.86 “Replidyne Pediatrician Sales Force”
means those members of Replidyne’s sales force (subject to
the provisions of Section 2.4(b) of
Schedule 5.5 , whether Replidyne employees,
contractors or agents), who promote Product to Pediatricians in the
Territory pursuant to Replidyne’s exercise of the
Pediatrician Promotion Option, together with field-based sales
managerial personnel having direct and sole responsibility for the
management of such sales force.
1.87 “Replidyne Specialist Promotion
Period” means the period beginning on the Detailing
Commencement Date and ending on the last day of the fifth (5
th ) Detailing Year, unless extended by mutual
agreement of the parties or sooner terminated in accordance with
the terms of this Agreement.
1.88 “Replidyne Specialty Sales Force”
means those members of Replidyne’s sales force (subject to
the provisions of Section 5.4(a) , whether Replidyne
employees, contractors or agents), who promote Product to Target
Specialists in the Field in the Territory pursuant to
Section 5.2 , together with field-based sales
managerial personnel having direct and sole responsibility for the
management of such sales force.
1.89 “Royalty Payments” shall have the
meaning provided in Section 7.5(a) .
1.90 “Royalty Term” means, in the case of
any Product in the Territory (on a Product-by-Product basis), the
period of time commencing on the First Commercial Sale of such
Product in the Territory and, subject to the provisions of
Section 7.5 , ending upon the later of: (a) the
expiration of the last to expire valid claim of the Licensed
Patents, Forest Patents or Joint Patents claiming the manufacture,
use or sale of such Product in the Territory, including any period
of extended commercial exclusivity for the Product granted under
any such Licensed Patent, Forest Patent or Joint Patent or under
any other laws or regulations in the Territory, (b) the
commercial introduction by a Third Party of a Generic Equivalent to
such Product in the Territory; and (c) twelve (12) years
after the date of First Commercial Sale of such Product in the
Territory.
1.91 “Sales Force Expense” means the
salaries, bonuses, other cash compensation payments and benefits
provided by Replidyne to the Replidyne Specialty Sales Force,
together
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
12.
with direct
out-of-pocket expenses of Replidyne in utilizing the Replidyne
Specialty Sales Force in the Detailing of the Product (such as
automobile, travel and lodging, equipment and other support costs)
recognized and recorded in accordance with US GAAP. In addition,
“Sales Force Expense” shall include out-of-pocket costs
of activities in support of the Replidyne Specialist Sales Force
(for example, training and technology support services), provided
that Replidyne shall first consult with Forest to determine whether
such support services may be provided by Forest (in which case
Forest shall have the option to provide such services and Replidyne
shall utilize such services if so provided by Forest) and to the
extent not so available from Forest, such costs shall only be
included in Sales Force Expense to the extent such costs do not
exceed the incremental costs Forest would have incurred in
providing such services to its own sales force. Promptly following
the Effective Date, the JMC will develop a mutually agreed protocol
consistent with this definition to more specifically identify and
standardize the components of Sales Force Expense to facilitate the
reimbursement of such expense as contemplated by this
Agreement.
1.92 “Specialists” means physicians whose
practices are limited to treating a specific disease, specific
parts of the body, a specific age group or specific procedures, who
are potential prescribers of the Products.
1.93 “Standstill Period” has the meaning
provided in Section 15.1 .
1.94 “Supply Transition” means the period
of time, commencing on the Effective Date, during which the parties
shall transition responsibility from Replidyne to Forest under the
API Supply Agreement and Replidyne’s other agreements with
Third Party contract manufacturers for the Product.
1.95 “Tablet” means a finished
pharmaceutical preparation containing the Drug Substance as an
active ingredient, consisting of a solid dosage formulation for
delivery by mouth intended to be swallowed whole and to dissolve in
the gastrointestinal tract.
1.96 “Target Specialists” means
infectious disease specialists, otolaryngologists, and such other
Specialists (other than Pediatricians) as to which the JMC may
agree warrant Detailing of the Product.
1.97 “Term” has the meaning provided in
Section 12.1 .
1.98 “Territory” means the United States
of America, and its territories and possessions, including Puerto
Rico irrespective of political status.
1.99 “Third Party” means any entity other
than Replidyne or Forest or an Affiliate of Replidyne or
Forest.
1.100 “Trademark” means any trade names
or trademarks for the Product that are selected for use in the
marketing and promotion of the Product in the Territory in
accordance with the terms hereof (but not including trademarks or
trade names of general use in a party’s business and not
specifically related to the Product).
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
13.
1.101 “US GAAP” means generally
recognized accounting principles in the United States of
America.
1.102 “Wyeth” means Wyeth-Ayerst, a prior
licensee of the DAP Know-How and DAP Patents pursuant to a license
agreement with Suntory Ltd., Tokyo, Japan, a predecessor in
interest to DAP, dated May 27, 1992, which was terminated
March 22, 1996.
2.1 License Grants. Subject to the terms and conditions of
this Agreement, Replidyne hereby grants to Forest during the
Term:
(a) a co-exclusive license (or sublicense, as the case
may be) under the Licensed Technology, with the right to sublicense
to Affiliates under Section 2.2 , to conduct
development of Product in the Field in the Territory pursuant to
the Development Plan;
(b) an exclusive license (or sublicense, as the case
may be) under the Licensed Technology, with the right to sublicense
to Affiliates under Section 2.2 , to make and have made
anywhere in the world, excluding Japan (except to the extent rights
in Japan are included in the rights granted to Replidyne under the
DAP Agreement), Product for the Territory from Drug Substance
supplied by a Third Party approved by Replidyne;
(c) a co-exclusive license (or sublicense, as the case
may be) under the Licensed Technology, with the right to sublicense
under Section 2.2 , to use, market and promote Product
in the Field in the Territory;
(d) an exclusive license (or sublicense, as the case
may be) under the Licensed Technology, with the right to sublicense
under Section 2.2 , to sell, offer for sale and import
Product in the Field in the Territory; and
(e) a co-exclusive license (or sublicense, as the case
may be) with the right to sublicense under Section 2.2
, to use and display the Trademarks and the DAP Logogram in
connection with the promotion, marketing and commercialization of
Product in the Field in the Territory.
The
licenses (or sublicenses, as the case may be) granted in
Section 2.1(a) , (c) and (e) shall be
co-exclusive with Replidyne, meaning that Forest and Replidyne will
share such rights, on an exclusive basis as to Third Parties, with
respect to Products in the Territory as set forth in this
Agreement. The licenses (or sublicenses, as the case may be)
granted in Section 2.1(b) and (d) shall be
exclusive, meaning that such rights with respect to Products in the
Territory are exclusive, even as to Replidyne, its Affiliates and
any Third Parties, but subject to the rights of Replidyne as set
forth in this Agreement.
In
addition, in the event the launch of a Generic Equivalent to a
Product (on a Product-by-Product basis) by a Third Party [ ***
] , the licenses granted to Forest pursuant to this Agreement
shall be deemed to include the sale and distribution by Forest of
such Product as a generic Product subject to
Section 7.5 . For purpose of this Agreement, references
to “generic
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
14.
Product”
means a product having the same active ingredient(s), dosage form,
route of administration and strength as the Product, but is sold by
Forest without use of the Trademark [ *** ] in a manner
typical of the generic industry.
Forest
shall not exercise the foregoing license if it appears that the
Generic Equivalent [ *** ] . However, Forest or its
Affiliates or sublicensees may nevertheless exercise the foregoing
license if, [ *** ] . If sales of the Generic Equivalent
terminate for any reason, then Forest will promptly cease the sale
and distribution of its generic Product or, to the extent to do so
would be prohibited by law or would violate best industry
practices, cease the active promotion for sale of the generic
Product.
2.2 Sublicenses. Forest shall have the right to grant
sublicenses of the rights granted to it under this Agreement
(a) to its Affiliates upon prior written notice to Replidyne
and (b) to Third Parties with the prior written consent of
Replidyne in its sole discretion, and Forest shall have no other
right to sublicense. Sublicenses granted by Forest to its
Affiliates under this Agreement shall not permit the further grant
of sublicenses unless agreed to in writing by Replidyne in its sole
discretion. Any sublicense granted by Forest under this Agreement
shall be subject and subordinate to, and consistent with, the terms
and conditions of this Agreement. Forest shall remain fully
responsible for the conduct of its Affiliates and Third Party
sublicensees under the terms of this Agreement, including any
breach of the terms hereof by such Affiliates or sublicensees, and
any action or inaction by such Affiliate or Third Party sublicensee
shall be considered the action or inaction of Forest under this
Agreement (including, without limitation, for purposes of the
definition of Net Sales). In the event of a material default by an
Affiliate or Third Party under a sublicense agreement with Forest,
Forest will inform Replidyne and take such action as necessary or
appropriate to cure such default.
2.3 Grant to Replidyne by Forest. Subject to the terms and
conditions of this Agreement, Forest hereby grants to Replidyne and
its Affiliates, during the Term, (a) a non-exclusive,
worldwide, [ *** ] license under the Forest Technology to:
(i) perform Replidyne’s obligations under the
Development Plan (with no right to sublicense); and (ii) to
develop, make, have made, use, sell, offer for sale and import the
Product outside the Territory (with the right to sublicense to the
extent and during any period that Replidyne has the necessary
licenses from DAP with respect to territories outside the
Territory); and (b) a fully paid, royalty-free license under
the Forest Technology, with the right to sublicense only to
Affiliates of Replidyne, to use, market and promote the Product in
the Field in the Territory in accordance with Replidyne’s
promotion rights and obligations under this Agreement.
Notwithstanding the preceding, in the event that [ *** ]
.
2.4 Related
Compounds. If a party proposes to develop or acquire rights to
any analogs, homologues, derivatives, salts, metabolites, esters,
isomers, enantiomers, polymorphs or pro-drugs of Drug Substance
during the Term, the parties agree to work together with regard to
such activities and shall discuss and agree upon matters regarding
intellectual property rights and payment for costs prior to the
development or acquisition of the foregoing. Any rights developed
or acquired by a party during the Term as to any analogs,
homologues, derivatives, salts, metabolites, esters, isomers,
enantiomers, polymorphs or pro-drugs of Drug Substance shall be
included in the definition of Drug Substance and shall be deemed
governed by and subject to the terms and conditions hereof (
i.e. , irrespective of which party acquires such rights, all
intellectual
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
15.
property rights
relating thereto shall be deemed included in Licensed Technology
licensed to Forest pursuant to Section 2.1 or in Forest
Technology licensed to Replidyne pursuant to
Section 2.3 , and any finished pharmaceutical product
containing such compound shall be deemed a “Product”
for all purposes of this Agreement). No such product shall be
commercialized in the Territory during the term without the mutual
agreement of the parties.
2.5 Trademark and Trade Dress Matters.
(a) Sale under Trademarks . In the Territory,
Forest and its Affiliates will sell Products exclusively under the
Trademark in accordance with the terms and conditions set forth in
this Agreement. The Trademark has been selected by Replidyne and
submitted to the FDA prior the Effective Date. If the FDA does not
approve the use of such submitted Trademark or if either party
determines to use an alternate Trademark in the Territory, the
parties shall select by mutual agreement an alternate Trademark for
use with the Product. The Trademark shall be owned by Replidyne,
subject to the license granted to Forest herein.
(b) Use of Names and Logos on Product and Related
Materials . Subject to Applicable Laws, all packaging and
labels and all sales, advertising and promotional literature and
other materials used in connection with Products in the Territory
shall indicate that the Product is sold under license from
Replidyne and shall bear the names and logos of both Replidyne and
Forest. As used in this Agreement, “labels” or
“labeling” means labels and other written, printed or
graphic matter, including without limitation artwork upon the
Products or any container utilized with the Products, and
“packaging” means containers, cartons, shipping cases,
package inserts or other similar material used in packing or
accompanying the Products. The place and manner of use of the names
and logos of Replidyne and Forest shall be determined by Forest in
consultation with Replidyne, but in any event shall be of equal
size and prominence.
(c) Use of DAP Name and DAP Logogram . Subject
to Applicable Laws and provided that there is adequate space,
Forest and its Affiliates shall specify on certain packaging and
labels used in connection with Products, as mutually agreed (but
not including any sales, advertising or promotional literature or
other materials), that Products are manufactured and sold under a
license from Daiichi Asubio Pharmaceutical, Inc., Tokyo Japan, and
Forest and its Affiliates shall use on Products and certain of
their labels, packaging, literature, advertising and other printed
materials as mutually agreed the DAP Logogram. The place and manner
of such information and DAP Logogram shall be subject to agreement
with DAP, such approval not to be withheld if such information and
DAP Logogram are used in accordance with DAP’s normal
practices.
(d) Trademark Use . The manner of use of the
Trademarks shall be subject to periodic review by the JMC. Forest
shall not use the Trademarks in a way that would diminish their
value, and Forest shall not use a trademark confusingly similar to
one of the Trademarks with any of its other products or use the
Trademarks in combination with Forest’s other trademarks in a
manner which would create combination marks. Forest shall comply
with reasonable policies for usage of Trademarks, as approved by
the JMC from time to time. Replidyne shall utilize the Trademarks
within the Territory only in accordance with this Agreement.
Replidyne may utilize the Trademarks outside the Territory, except
that, if there is a reasonable likelihood of a negative impact from
parallel imports of Product (or corresponding
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
16.
Generic
Equivalents) using the Trademark from outside the Territory into
the Territory, then Replidyne may utilize such Trademark outside
the Territory only with Forest’s prior written approval,
which shall not be unreasonably withheld or delayed in light of
Replidyne’s proposals to address such negative impact from
parallel imports. If Forest reasonably withholds its approval of
the use of the Trademark outside the Territory, Replidyne shall not
authorize the use of the Trademark by DAP outside the Territory. If
DAP nevertheless uses the Trademark outside the Territory,
Replidyne shall be responsible, in its sole discretion, to enforce
its rights with respect to the Trademark under the DAP Agreement.
Replidyne shall hold Forest harmless from any direct damages
incurred by Forest as a result of parallel imports of Product
attributable to DAP’s un-authorized use of the Trademark
outside the Territory or as a result of other actions taken by DAP
directly resulting from Replidyne’s refusal to permit DAP to
use the Trademark outside the Territory, subject to
Section 10.5 .
2.6 Sales Outside the Territory. To the extent not otherwise
prohibited by law, neither Forest nor its Affiliates or permitted
sublicensees shall sell Product to customers outside the Territory
or to any Third Party in the Territory that Forest has reasonable
grounds to believe are likely to export Product outside the
Territory. If Forest becomes aware that a Third Party in the
Territory is exporting Products acquired from Forest to a country
outside the Territory, then Forest shall use Commercially
Reasonable Efforts within its legal rights and the remedies
afforded by Applicable Laws to deter such Third Party from
continuing such exportation, including, without limitation by
ceasing or limiting the supply of Product to such Third Party. All
inquiries or orders received by Forest for Products to be delivered
outside of the Territory shall be referred to Replidyne. To the
extent not otherwise prohibited by law, neither Replidyne nor its
Affiliates or licensees will sell Product to customers inside the
Territory or to any Third Party that Replidyne has reasonable
grounds to believe are likely to import Product into the Territory.
If Replidyne becomes aware that a Third Party outside the Territory
is exporting Product acquired from Replidyne or any Affiliate or
licensee to a country within the Territory, then Replidyne shall
use Commercially Reasonable Efforts within its legal rights and the
remedies afforded by Applicable Laws to deter such Third Party from
continuing such exportation, including, without limitation, by
ceasing or limiting the supply of Product to such Third Party. All
inquiries or orders received by Replidyne for Products to be
distributed within the Territory shall be referred to
Forest.
2.7 Retained
Rights; No Implied Licenses. For avoidance of doubt, the
licenses granted in Section 2.1 shall not in any way be
interpreted as granting Forest a license to manufacture or have
manufactured Drug Substance or to sell the Drug Substance, except
to the extent included in rights granted to Replidyne under the DAP
Agreement, the API Supply Agreement or otherwise included in the
Licensed Patents and Licensed Know-How. Replidyne hereby expressly
reserves the right to practice, and to grant licenses under, the
Licensed Patents, the Joint Patents and the Licensed Know-How for
any and all purposes except to the extent that Forest has been
granted a license under Section 2.1 and reserves such
rights to practice intellectual property rights, including the
Manufacturing Technology, to which it may obtain a license under
the API Supply Agreement except to the extent that Forest may be
granted a license under Section 6.5 . No right or
license under any Patents or other intellectual property rights of
either party is granted or shall be granted by implication to the
other, and each party agrees not to practice any Patents or other
intellectual property rights of the other party except
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
17.
pursuant to the
licenses expressly granted in this Agreement or any other written
agreement between the parties. All such rights or licenses are or
shall be granted only as expressly provided in the terms of this
Agreement.
|
3.
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Collaboration
Governance
|
3.1 Joint Development Committee.
(a) Formation . Promptly after the Effective
Date, the parties will form a Joint Development Committee (the
“JDC” ) comprised of three
(3) representatives of each of Forest and Replidyne. One
(1) member of the JDC shall be selected to act as the
chairperson of the JDC, with each chairperson acting for a term of
twelve (12) months. The chairperson shall be selected
alternately by Replidyne and Forest, and Replidyne shall designate
the first chairperson. The JDC shall meet at least four
(4) times per year or at such greater frequency as the JDC
agrees. Such meetings may be conducted by videoconference,
teleconference or in person, as agreed by the parties (except that
at least two (2) of such meetings per year shall be conducted
in person), and the parties shall agree upon the time of meetings.
Within thirty (30) days after each meeting, the JDC
chairperson will prepare and distribute to the other members of the
JDC for review and comment reasonably detailed minutes of such
meeting, which will be approved as the first order of business at
the immediately succeeding JDC meeting. Subject to prior
coordination with the other party, a reasonable number of
additional representatives of a party may attend meetings of the
JDC in a non-voting capacity, consistent with the agendas and
purposes for such meetings.
(b) Responsibilities . The JDC shall oversee
and manage the development (including clinical and non-clinical
activities) and regulatory approval of the Product in the Field in
the Territory. In addition to its general responsibilities, the JDC
shall in particular:
(i) encourage and facilitate communication between the
parties with respect to the Development Program;
(ii) establish, update, amend, review and approve the
Development Plan for accomplishing the goals of the Development
Program;
(iii) oversee development and regulatory strategies
for Products;
(iv) monitor progress of the Development Program and
each party’s diligence in carrying out its responsibilities
thereunder; and
(v) carry out the other duties and responsibilities
described for it in this Agreement.
(c) JDC Decision-Making . Decisions of the JDC shall
be made by unanimous vote, with the Replidyne members collectively
having one (1) vote and the Forest members collectively having
one (1) vote. No vote of the JDC may be taken unless at least
two (2) of each party’s representatives on the JDC are
present to vote. If the JDC is unable to reach a unanimous vote on
any matter, then the matter shall be referred to the Chief
Executive Officer of Replidyne
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
18.
and the Chief
Executive Officer of Forest’s corporate parent, Forest
Laboratories, Inc. ( “Forest Parent” )
for further discussion and resolution. These individuals shall as
soon as practicable attempt in good faith to resolve the matter and
thereby make the decision on behalf of the JDC. These individuals
may obtain the advice of other employees or consultants as they
deem necessary or advisable in order to make the
decision.
(d) Limits on Authority . The JDC will have only such
powers as are specifically delegated to it in this Agreement, and
will have no power to amend this Agreement or waive a party’s
rights or obligations under this Agreement.
3.2 Joint Marketing Committee.
(a) Formation . Promptly after the Effective
Date, the parties will form a Joint Marketing Committee (the
“JMC” ) comprised of three
(3) representatives of each of Forest and Replidyne. The
chairperson of the JMC shall be selected by Forest. The JMC shall
meet at least four (4) times per year or at such greater
frequency as the JMC agrees. Such meetings may be conducted by
videoconference, teleconference or in person, as agreed by the
parties (except that at least two (2) of such meetings per
year shall be conducted in person), and the parties shall agree
upon the time of meetings. Within thirty (30) days after each
meeting, the JMC chairperson will provide the parties with a
written report describing, in reasonable detail, the status of the
parties’ activities under the Marketing Plan, a summary of
the results and progress to date, the issues requiring resolution,
and the agreed resolution of previously reported issues. Subject to
prior coordination with the other party, a reasonable number of
additional representatives of a party may attend meetings of the
JMC in a non-voting capacity, consistent with the agendas and
purposes for such meetings. Each party shall make available
personnel having responsibility for Product development for
consultation with or membership on the JMC at such times and to the
extent the JMC is considering issues relating to Phase IV or other
clinical trials of the Product.
(b) Responsibilities . The JMC shall oversee
and manage the commercialization strategy for Products in the Field
in the Territory. In addition to its general responsibilities, the
JMC shall in particular:
(i) review and approve the Marketing Plan, including,
without limitation, the portions relating to marketing to Target
Specialists and Pediatricians, and amendments and updates
thereto;
(ii) develop strategies for conducting Phase IV
clinical trials of Products following the initial NDA Approval to
support marketing the Product;
(iii) coordinate the parties selling activities among
Primary Care Physicians and Specialists, including Target
Specialists and Pediatricians; and
(iv) carry out the other duties and responsibilities
described for it in this Agreement.
(c) JMC Decision Making . Decisions of the JMC
shall be made by
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
19.
unanimous vote,
with the Replidyne members collectively having one (1) vote
and the Forest members collectively having one (1) vote. No
vote of the JMC may be taken unless at least two (2) of each
party’s representatives on the JMC are present to vote. If
the JMC is unable to reach a unanimous vote on any matter,
including, without limitation, as to the approval or amendment of
any Marketing Plan, the matter shall be referred to the Chief
Executive Officer of Replidyne and the Chief Executive Officer of
Forest Parent for further discussion and resolution. These
individuals shall as soon as practicable attempt in good faith to
resolve the matter and thereby make the decision on behalf of the
JMC. These individuals may obtain the advice of other employees or
consultants as they deem necessary or advisable in order to make
the decision. Except as provided in the following two sentences, if
the Chief Executive Officer of Replidyne and the Chief Executive
Officer of Forest Parent are unable to reach agreement on any such
matter, including, without limitation, as to the approval or
amendment of any Marketing Plan (including the determination of
aggregate Marketing and Sampling Expense and the allocation thereof
among the various components of such expense, such as medical
education, sales aids, sample expense and journal advertising), the
Chief Executive Officer of Forest Parent shall have the final
decision-making authority on such matter. If Replidyne is then
participating in promotional activities with respect to Target
Specialists, the strategic objectives and total funding commitment
and allocation thereof for promotional activities directed to
Target Specialists to be reflected in the Marketing Plan will be
decided as above, however any matter relating to the implementation
of the strategic objectives of the Marketing Plan with respect to
the promotion of the Product to Target Specialists, including the
specific uses of allocated funding, must be resolved by the Chief
Executive Officer of Replidyne and the Chief Executive Officer of
Forest Parent, which resolution must be consistent with the overall
marketing strategy determined by the JMC for the Tablets, as
reflected in the Marketing Plan. If Replidyne has exercised the
Pediatrician Promotion Option and is then participating in
promotional activities with respect to Pediatricians, then any
matter that relates to the pediatric portion of the Marketing Plan
(including its approval or amendment, provided, however, that such
pediatric portion of the Marketing Plan shall be consistent with
the overall Marketing Plan) or its implementation including,
without limitation, marketing and Detailing of the Oral Suspension
to Pediatricians and non-Pediatricians, must be resolved by the
Chief Executive Officer of Replidyne and the Chief Executive
Officer of Forest Parent.
(d) Limits on Authority . The JMC will have
only such powers as are specifically delegated to it in this
Agreement, and will have no power to amend this Agreement or waive
a party’s rights or obligations under this
Agreement.
3.3 Cost of Goods Committee.
(a) Formation . Promptly after the Effective
Date, the parties will form a Cost of Goods Committee comprised of
two (2) representatives of each of Forest and Replidyne, and
the CGC will be operative during any period that it appears
reasonably likely, based upon objective evidence discussed by the
parties, that the Cost of Goods for a period will exceed [ ***
] . The CGC shall oversee matters impacting the Cost of Goods
for Products [ *** ] . For example, the CGC shall review
financial decisions for each formulation of the Product that relate
to: (i) pricing and discounting strategies; (ii) dosing
and duration of therapy; and (iii) Drug Substance cost
reduction strategies, including hedging of exchange rate risk. The
CGC shall meet at least two (2) times per year or at such greater
frequency as the CGC agrees. Such
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
20.
meetings may be
conducted by videoconference, teleconference or in person, as
agreed by the parties (except that at least two (2) of such
meetings per year shall be conducted in person), and the parties
shall agree upon the time of meetings. Within thirty (30) days
after each meeting, the CGC chairperson will provide the parties
with a written report describing, in reasonable detail, relevant
matters pertaining to Cost of Goods, any issues requiring
resolution, and the agreed resolution of previously reported
issues. Subject to prior coordination with the other party, a
reasonable number of additional representatives of a party may
attend meetings of the CGC in a non-voting capacity, consistent
with the agendas and purposes for such meetings.
(b) CGC Decision Making . Decisions of the CGC
shall be made by unanimous vote, with the Replidyne members
collectively having one (1) vote and the Forest members
collectively having one (1) vote. No vote of the CGC may be
taken unless at least one (1) of each party’s
representatives on the CGC is present to vote. If the CGC is unable
to reach a unanimous vote on any matter, such matter shall instead
be referred to the Chief Executive Officer of Replidyne and the
Chief Executive Officer of Forest Parent for further discussion and
resolution. These individuals shall as soon as practicable attempt
in good faith to resolve the matter and thereby make the decision
on behalf of the CGC. These individuals may obtain the advice of
other employees or consultants as they deem necessary or advisable
in order to make the decision. If the Chief Executive Officer of
Replidyne and the Chief Executive Officer of Forest Parent are
unable to reach agreement on any matter, the Chief Executive
Officer of Forest Parent shall have the final decision-making
authority on such matter.
(c) Limits on Authority . The CGC will have
only such powers as are specifically delegated to it in this
Agreement, and will have no power to amend this Agreement or waive
a party’s rights or obligations under this
Agreement.
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4.
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Conduct of
the Development Program
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4.1 Development Program Activities. Development and
regulatory activities for Products in the Field in the Territory
will be conducted as outlined in the Development Plan. For
clarification, Phase IV marketing studies are not considered to be
development activities. The JDC shall determine on a Calendar
Quarter basis the number of FTEs of each party that will work on
the Development Program during such Calendar Quarter. Any
amendments or revisions to the Development Plan shall be in writing
and shall require unanimous approval of the JDC. Each party, as
applicable, will use Commercially Reasonable Efforts to execute and
to perform, or cause to be performed, the activities set forth in
the Development Plan, in each case in compliance with the terms of
this Agreement and Applicable Laws. If a party proposes development
activities for Products in the Field in the Territory, but the JDC
does not reach agreement to include such development activities in
the Development Plan, the parties will discuss and agree whether
one party can proceed with such development activities at its own
expense and, if so, on what terms the results of such development
activities would be made available to the other party by the party
that conducts such development activities.
4.2 Oral Suspension Development. As a specific activity
under the Development Program, the parties will collaborate to
complete development of an Oral Suspension, with the goal of
maximizing efficiency and controlling Development Costs by
utilizing the expertise and existing resources of each of the
parties. The JDC shall allocate tasks between the parties and
to
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
21.
Third Parties
based on the availability of expertise to conduct development
activities cost effectively. The allocation of each party’s
responsibilities shall be set forth in the Development
Plan.
4.3 Technology and Information Transfer. Commencing promptly
after the Effective Date and from time to time thereafter during
the Term, Replidyne shall disclose to Forest such Licensed
Technology in Replidyne’s possession as is reasonably
necessary or useful to enable Forest to exercise fully the licenses
granted to Forest under Article 2 . Commencing promptly
after the Effective Date and from time to time thereafter during
the Term, Forest will disclose to Replidyne such Forest Technology
in Forest’s possession as is reasonably necessary or useful
to enable Replidyne to perform its Development Program activities
hereunder in accordance with the Development Plan and otherwise to
exercise fully the licenses granted to Replidyne under
Article 2 hereof. Each party will, at no cost or
expense to the other party, provide such other party with copies of
or access to any and all Development Information generated or
otherwise obtained in the development of Products as provided in
this Section 4.3 , all of which Development Information
may be used and referenced by or on behalf of Forest in the
development, manufacture and/or commercialization of Product in the
Field in the Territory in accordance with the terms of this
Agreement and by or on behalf of Replidyne in the performance by
Replidyne of the development and commercialization activities with
respect to the Product in the Field in the Territory in accordance
with the terms of this Agreement and (including, as appropriate
and, without limitation, by DAP) in the development, manufacture
and/or commercialization of Product in the Field outside the
Territory, including, without limitation, in the preparation,
submission, filing, prosecution and maintenance of regulatory
approvals in the applicable territory. Moreover, upon reasonable
written notice from a party, the other party will provide
regulatory authorities with access to any Development Information
for inspection and/or review as may be required under Applicable
Law.
4.4 Clinical Supply. The parties will utilize
Replidyne’s Product facility for Development Program purposes
(e.g., Oral Suspension and Tablet formulation development) unless
and until alternative facilities are available, with the costs
incurred for such activity treated as Development Costs. Costs of
manufacture and supply of Drug Substance and Product for
development activities, including clinical trials, shall be treated
as a Development Cost. Subject to the foregoing, the JSC (or if the
JSC no longer exists, the party that is in charge of supply) shall
be responsible for arranging for the supply of Drug Substance
necessary for producing required clinical quantities of Product.
Responsibility for packaging and labeling of clinical quantities of
Product shall be assigned in the Development Plan.
4.5 Development Reports. Each party shall keep the other
party fully informed as to all discoveries and technical
developments (including, without limitation, any Inventions) made
in the course of performing activities under the Development
Program. In particular, each party shall prepare, and distribute to
all members of the JDC no later than ten (10) days prior to
the next JDC meeting, such report as the JDC may request setting
forth such information regarding the results and progress of
performance of the Development Program. Nothing herein shall
require a party to disclose information received from or generated
for a Third Party that remains subject to bona fide
confidentiality obligations to such Third Party; provided that
neither party shall undertake any such confidentiality obligations
in favor of Third Parties to the extent such obligations could
reasonably be expected to prevent the sharing of information
necessary or
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
22.
useful for the
efficient conduct of the Development Program.
(a) Allocation of Costs . Replidyne will bear
[ *** ] percent ( [ *** ] %) and Forest will bear
[ *** ] percent ( [ *** ] %) of the Development Costs
incurred by the parties under the Development Plan, including
without limitation Development Costs incurred for clinical
development necessary to support NDAs for a Tablet in a 600 mg
dosage and an Oral Suspension.
(b) Reports and Payments . Each party shall
report to the other party within thirty (30) days after the
end of each Calendar Quarter the Development Costs incurred by such
party during such Calendar Quarter. Such report shall specify in
reasonable detail all amounts included in such Development Costs
during such Calendar Quarter (broken down by activity) and shall be
accompanied by invoices or other appropriate supporting
documentation for any payments made by such party to Third Parties
that individually exceed fifty thousand dollars ($50,000) or as may
be determined by the JDC. Within forty five (45) days after
the end of each Calendar Quarter, the party that has paid less than
its share of such Development Costs as provided in
Section 4.6(a) shall make a reconciling payment to the
other party to achieve the appropriate allocation of Development
Costs provided in Section 4.6(a) . Each such report
shall enable the receiving party to compare the reported
Development Costs against the Development Plan, on both a quarterly
basis and a cumulative basis for each activity. The parties shall
seek to resolve any questions related to such accounting statements
within fifteen (15) days following receipt by each party of
the other party’s report hereunder.
4.7 Registration Activities. Regulatory strategy for the
Product and all decision-making with respect thereto shall be
determined by the JDC. Prior to the Effective Date, Replidyne has
prepared and submitted to the FDA a NDA for a Tablet in a 300 mg
dosage. Replidyne and Forest will collaborate to develop and
prepare for submission any supplemental NDAs or additional NDAs for
the Products, with the specific responsibilities of each
party’s personnel to be assigned by the JDC based on the
availability of expertise and resources within each party’s
organization. Replidyne shall hold the NDA for the Tablet and any
subsequent supplemental NDAs for the Tablet until approval of the
NDA for the Tablet, at which time Forest will become the holder of
such NDA. The IND and NDA for the Oral Suspension will be filed in
Replidyne’s name, and Replidyne shall hold the NDA and any
subsequent supplemental NDAs for the Oral Suspension until approval
of the NDA for the Oral Suspension, at which time Forest will
become the holder of such NDA. Irrespective of which party prepares
any such NDA or portion thereof, the other party shall be given the
opportunity to review and provide comments on any such submission
and no such NDA (including any supplemental NDA) shall be submitted
for filing to the FDA without the mutual agreement of Forest and
Replidyne, such consent not to be unreasonably withheld or delayed.
Forest and Replidyne shall keep one another fully informed of the
registration process of Product through the Joint Development
Committee. Each party shall use Commercially Reasonable Efforts to
obtain in a timely manner NDA Approvals for Products.
4.8 Meetings and Communications with the FDA. As of the
date(s) to be mutually agreed by the parties, but in any event
within six (6) months after the Effective Date, Forest
shall
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
23.
be designated
as Replidyne’s agent for purposes of adverse event reporting,
sample tracking and submissions and interactions with the
FDA’s Division of Drug Marketing, Advertising and
Communications with respect to Products in the Territory and shall
have the primary responsibility for the associated subject matters.
Subject to the provisions of Section 4.7 , Replidyne
shall be primarily responsible for and have the authority to
conduct interactions with the FDA regarding NDA approval matters
until transfer of the NDA to Forest, following which Forest shall
have such primary contact responsibilities. Irrespective of which
party has such primary contact responsibility, the other party
shall be notified in advance of any substantive communications with
the FDA and shall be afforded the opportunity to participate in
such communications. Subject to the preceding sentence, to the
extent permitted by the FDA, Replidyne and Forest shall mutually
attend all meetings, participate in any oral communications and
agree upon any written communications with the FDA relating to
Product and labeling discussions with the FDA shall be conducted
jointly by Forest and Replidyne.
4.9 Subcontracts. Each party may perform some of their
obligations under the Development Plan through one (1) or more
Affiliates or subcontractors; provided that (a) none of
the rights of either party hereunder are diminished or otherwise
adversely affected as a result of such subcontracting, and
(b) the Affiliate or subcontractor undertakes in writing
obligations of confidentiality and non-use regarding Confidential
Information which are substantially the same as those undertaken by
the parties pursuant to Article 11 hereof. If a party
performs any of its obligations under this Agreement through an
Affiliate or subcontractor, then such party will at all times be
responsible for the performance and payment of such Affiliate or
subcontractor and will actively monitor and supervise the work of
such Affiliate or subcontractor. Notwithstanding the foregoing, in
the event a party desires to use a subcontractor hereunder, it will
first offer the other party the opportunity to provide the affected
services utilizing its internal resources to the extent such other
party possesses qualified resources to provide such services in a
timely and efficient manner and at a cost competitive to the use of
Third Party resources.
4.10 Materials Transfer. In order to facilitate the
Development Program, either party may provide to the other party
certain biological materials or chemical compounds Controlled by
the supplying party (collectively,
“Materials” ) for use by the other party
in furtherance of the Development Program. Except as otherwise
provided under this Agreement, all such Materials delivered to the
other party will remain the sole property of the supplying party,
will be used only in furtherance of the Development Program in
accordance with this Agreement, will not be used or delivered to or
for the benefit of any Third Party without the prior written
consent of the supplying party, and will be used in compliance with
all applicable laws, rules and regulations. The Materials supplied
under this Agreement must be used with prudence and appropriate
caution in any experimental work because not all of their
characteristics may be known. Except as expressly set forth herein,
and provided that the materials shall comply with any certificate
of analysis or specifications provided by or on behalf of the
supplying party, the
Materials are provided “as is” and without any
representation or warranty, express or implied, including without
limitation any implied warranty of merchantability or of fitness
for any particular purpose or any warranty that the use of the
Materials will not infringe or violate any patent or other
proprietary rights of any third party.
4.11 Liability. In connection with the conduct of the
Development Program, Replidyne will bear [ *** ] and Forest
will bear [ *** ] of any liability for personal injury
or
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
24.
property damage
arising in connection with the conduct of the clinical development
activities and the indemnification obligations of the parties set
forth in Article 13 with respect to these matters shall
be applied in a manner consistent with such allocation of
liability; provided, however , that each party shall be
responsible for, and hereby assumes, any and all risks of personal
injury or property damage attributable solely to the negligence or
willful misconduct of that party or its Affiliates, and their
respective directors, officers, employees and agents.
5.1 Forest General Commercial Responsibilities. Forest or
its Affiliate shall be responsible, at its own expense, for the
conduct of all promotion, marketing, sampling, pre-launch, launch
and sales activities with respect to Products in the Field in the
Territory, subject to Replidyne’s promotion, marketing,
sampling and sales activities with respect to Products to Target
Specialists in the Territory, as more fully described in
Section 5.4 , and if Replidyne exercises the
Pediatrician Promotion Option pursuant to Section 5.5 ,
to Pediatricians in the Territory.
5.2 Marketing Plans. Within a reasonable period of time
after the Effective Date, Forest or its Affiliate shall prepare and
submit to the Joint Marketing Committee for review and approval a
Marketing Plan. The Marketing Plan for each Detailing Year shall
include (a) marketing strategy, (b) sales forecasts,
(c) amounts budgeted for expenditures by Forest on Marketing
and Sample Expense for the Product in such Detailing Year,
(d) a sampling plan with respect to the Product, (e) the
aggregate number and monthly or quarterly breakdown of Detailing
calls with respect to the Product that are projected in such
Detailing Year, including the frequency of Details and the
proportion of Details to be provided in first and second positions,
and (f) the percentage of the total Detailing calls with
respect to the Product to be performed by the Replidyne Specialty
Sales Force in such Detailing Year and shall be prepared with input
from Replidyne, including specifically, input as to those portions
of the Marketing Plan describing activities directed to Target
Specialists, which shall be consistent with the overall Marketing
Plan for non-Target Specialists. A separate Marketing Plan shall be
prepared for each Product subsequently launched, the initial
version of which shall be submitted to the JMC for review and
approval not later than three (3) months after NDA Acceptance
for such Product. The Marketing Plan shall be updated on an annual
basis approximately [ *** ] months in advance of the
beginning of the next applicable Detailing Year. The JMC shall then
discuss and agree upon such updated Marketing Plan within thirty
(30) days after submission of such Marketing Plan to the
JMC.
(a) Forest shall use Commercially Reasonable Efforts
to promote, market and sell Product in the Field in the Territory
in accordance with the Marketing Plan.
(b) The launch of the Tablet in a 300 mg dosage by
Forest or its Affiliates in the Territory shall take place within
no more than six (6) months following NDA Approval of such
Product, including, for this purpose, FDA approval of labeling and
product launch promotional materials for such Product (provided
that such that such NDA Approval includes approval for use in
(i) acute sinusitis and (ii) and one of the following:
(A) community acquired
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
25.
pneumonia; or
(B) the AECB Indication, unless the JMC determines that
seasonality considerations support extending the launch time by up
to an additional three (3) months). In addition,
Forest’s obligation to launch is subject to having approved
dating for the Product of at least eighteen (18) months and
having available launch supplies of Product having such dating (it
being agreed that Forest shall be required to order Drug Substance
when it is commercially reasonable to do so, with the understanding
that receipt of an approvable letter from the FDA is not necessary
for a determination that it is commercially reasonable to order
Drug Substance for such Product supplies).
(c) Without limiting the generality of the foregoing, Forest
agrees that in each of the first [ *** ] sales years
following the First Commercial Sale of the first Tablet subject to
NDA Approval, Forest (i) will provide at least [ *** ]
Details for the Tablet and (ii) will incur at least [ ***
] dollars ($ [ *** ] ) in Marketing and Sample Expense;
provided that if there is any development (including
Forest’s launch of the Product with only one approved
respiratory indication) that is material and adverse to the market
potential for the Tablet or materially and adversely affects the
commercial value of Detailing efforts, and such specific commitment
is no longer commercially reasonable in light of such development,
then the preceding specific commitment shall be reduced to a
commercially reasonable level mutually agreed by the
parties.
(d) Following launch of the first Oral Suspension,
Commercially Reasonable Efforts with respect to the promotion and
marketing of the Product to all audiences in the Territory shall
require a significant increase over the level of resources applied
to the promotion of the Tablets alone in the preceding year to
reflect the additional value of the Oral Suspension. Without
limiting the generality of the foregoing, the party responsible for
promotional activities directed toward Pediatricians (i.e.,
Replidyne, if Replidyne has exercised the Pediatrician Promotion
Option, and otherwise Forest) shall provide at least [ *** ]
Details directed to Pediatricians during each of the first [ ***
] sales years following the First Commercial Sale of the Oral
Suspension; provided that if there is any development
(including launch of the Oral Suspension without approval of the
AOM Indication) that is material and adverse to the market
potential for the Oral Suspension or materially and adversely
affects the commercial value of Detailing efforts, and such
specific commitment is no longer commercially reasonable in light
of such development, then the preceding specific commitment shall
be reduced to a commercially reasonable level mutually agreed by
the parties.
(e) Irrespective of which party performs Detailing
activities directed toward Pediatricians, the Marketing Plan will
contain sections describing activities directed to Pediatricians,
as well as the marketing of the Oral Suspension to
non-Pediatricians, which sections will be consistent with the
JMC’s overall marketing strategy for the Product in the
Territory and with the overall Marketing Plan. The Marketing Plan
shall establish goals for Detailing of the Product to Pediatricians
and Detailing of the Oral Suspension to non-Pediatricians for each
Detailing Year, including establishing the number and frequency of
Details to be provided and the proportion of Details to be provided
in first and second positions. In addition, the Marketing Plan for
each Detailing Year shall also specify the proportion of Marketing
and Sample Expense for efforts directed to Primary Care Physicians
and other non-Pediatricians, on the one hand, to Marketing and
Sample Expense for efforts directed to Pediatricians, on the other
hand (the “Marketing Expense Ratio” ),
with the JMC allocating Forest’s Marketing and Sample Expense
directed to Primary Care Physicians and other non-
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
26.
Pediatricians
on a reasonable basis between the Tablet and the Oral Suspension so
that such Marketing and Sample Expense related to the Oral
Suspension may be used as the Non-Pediatrician Suspension Marketing
and Sample Expense, and shall specify minimum marketing
contributions to be made by Forest and Replidyne (if Replidyne has
exercised the Pediatrician Promotion Option), respectively, based
on the Marketing Expense Ratio. In the absence of objective
evidence to the contrary, the Marketing Expense Ratio shall assume
an equal per physician value of promotion to Pediatricians and
non-Pediatricians. In addition, whether or not Replidyne has
exercised the Pediatrician Promotion Option, the party performing
promotional activities directed to Pediatricians will use
Commercially Reasonable Efforts to execute such activities and the
diligence requirements of Section 2.3 of Schedule 5.5
shall apply to such promotional activities.
5.4 Replidyne
Commercial Activities for Target Specialists. Forest shall,
through Forest Parent, engage Replidyne to perform all marketing
and promotion-related activities for the Products directed to
Target Specialists. Replidyne will promptly notify Forest at any
time that it appears reasonably likely that Replidyne will not be
able to substantially achieve required levels of Detailing over any
significant period or in any significant area. Following any such
notice, the parties will meet and confer in good faith to develop a
plan to achieve such required levels of Detailing as promptly as
practicable, including through the reallocation of Replidyne
personnel, if practicable and without adversely affecting
Replidyne’s Detailing efforts, and the utilization of Forest
sales force personnel as reasonably required to achieve the
required levels of Detailing. Following the development of such
plan, Forest shall have the right to call on Target Specialists as
provided by the plan, in which case the JMC will coordinate the
efforts of each of Forest and Replidyne with respect to the
Detailing of Product to Target Specialists by each party. In
addition, if (a) Replidyne elects not to provide Details of
the Product to certain Target Specialists (e.g., due to a
particular geographical location), the Detail Reports indicate that
Replidyne’s Detailing has not achieved material Detailing
requirements to be performed by Replidyne as targeted by the
Marketing Plan (as to number or position of Details) over a
significant period or (b) the JMC determines, prior to a
formal annual update to the Marketing Plan, that Detailing efforts
to Target Physicians in addition to those in the then current
Marketing Plan are appropriate and authorizes additional funds, if
required (subject to the maximum funding set forth in
Section 7.10(c) ), to support such additional Detailing
efforts to Target Physicians, the parties will meet and confer in
the manner set forth above to develop a plan to address the
provision of additional Details, which plan will be based on the
considerations, and implemented by the parties, as provided above.
In any such event requiring the utilization of Forest sales force
personnel, the parties will cooperate to transition Detailing
efforts to Replidyne as promptly as practicable in light of the
need to assure a smooth transition of Detailing activities once
Replidyne possesses adequate resources to provide Detailing efforts
targeted by the Marketing Plan. During the Replidyne Specialist
Promotion Period, Replidyne will use its Commercially Reasonable
Efforts to provide Detailing to Target Specialists in accordance
with the Marketing Plan through the Replidyne Specialty Sales
Force.
(a)
Organization of Replidyne Specialty Sales Force . The JMC
will determine the number of Target Specialists to be on the call
plan, call frequency and other matters necessary to determine the
size of the Replidyne Specialty Sales Force. The JMC will also
determine what ancillary personnel and activities, if any, are
needed to enhance Target
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
27.
Specialist
promotional efforts and which are to be: (i) provided by
Replidyne at Replidyne’s cost; (ii) provided in-kind by
Forest for Replidyne’s use; or (iii) provided by
Replidyne but reimbursed by Forest. For purposes of determining the
size and geographical distribution of the Replidyne Specialty Sales
Force, the call plan will contemplate approximately [ *** ]
Target Specialists and a call frequency of an average of [ ***
] Details per Detailing Year; provided that in any
event, the Replidyne Specialty Sales Force will be comprised of at
least fifty (50) sales representatives, each having a sales
territory that allows such sales representative to call upon a
reasonable number of Target Specialists within a reasonable
geographic area (i.e., without overly-burdensome travel
requirements). During the Pre-Launch Period, Replidyne shall use
its Commercially Reasonable Efforts to engage and organize the
Replidyne Specialty Sales Force. The Replidyne Specialty Sales
Force will be organized by Replidyne under the general
recommendations and supervision of the JMC as to numbers and
qualifications of sales representatives and field-based sales
managerial personnel and the timing of hiring in light of the
then-current Marketing Plan. Such sales representatives shall have
qualification and experience at least comparable to Forest’s
sales representatives and shall be entitled to incentive
compensation with respect to the marketing of the Product on a
basis not materially less favorable to the Product than provided by
Forest to its sales representatives. During the Initial Period, the
Replidyne Specialty Sales Force may be comprised of personnel
provided by a contract sales organization; provided that at
the end of the first [ *** ] of the Initial Period, the JMC
shall determine whether:
(i) the Replidyne Specialty Sales Force has delivered
[ *** ] percent ( [ *** ] %) of the Details set forth
in the Marketing Plan for that time period;
(ii) at least [ *** ] percent ( [ *** ]
%) of the Details performed by Replidyne Specialty Sales Force
during that time period were delivered to Target Specialists on the
call panel and with the frequency and Detail position established
by the JMC; and
(iii) the performance by the Replidyne Specialty Sales
Force meets the metrics previously established by the JMC to be
measured in an ImpactRX report obtained at the [ *** ]
benchmark point.
If the Replidyne
Specialty Sales Force fails to meet the foregoing requirements,
Replidyne will provide written notice to Forest within [ ***
] of such determination by the JMC, indicating whether
Replidyne will (A) transition to a sales force comprised of
personnel who are full-time employees of Replidyne and coordinate
Detailing to Target Specialists together with Forest’s sales
representatives pending the achievement of a full-time employee
trained and qualified sales force or (B) terminate its
promotional efforts with respect to Target Specialists, in each
case over the course of the [ *** ] month period immediately
following such notice.
(b) Training Materials and Sessions . Forest shall
provide Replidyne with training materials Forest provides to the
Forest Sales Force, sufficient in quantity and quality to allow
Replidyne to train the Replidyne Specialty Sales Force in
Product-specific sales skills and to Detail the Product in a manner
consistent with the Detailing performed by the Forest Sales Force.
Replidyne will prepare or have prepared any supplementary training
materials required for Detailing the Product to the Target
Specialists, consistent with the applicable Marketing Plan. Forest
will permit Replidyne sales representatives to participate in
training sessions of the Forest
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
28.
Sales Force in
Product-specific sales skills with respect to the Product and the
indications for the Product and will provide reasonable advance
notice to Replidyne of scheduled training events. Without limiting
the generality of the foregoing, the parties intend that the
Replidyne Specialty Sales Force will participate in the initial
Product launch and subsequent sales force meetings to the extent
related to the Product.
(c) Promotional Materials . Forest shall provide
Replidyne with sales and promotional materials reasonably
sufficient to permit Replidyne to perform Detailing calls in a
manner consistent with the Detailing calls performed by the Forest
Sales Force. Replidyne will create or have created on its behalf
such additional sales and promotional materials intended to be
specific to the Target Specialist audience as called for under, and
consistent with, the Marketing Plan. The project managers of each
party will share with one another any such materials, and no such
materials may be utilized until completion of Forest’s
regulatory and compliance review.
(d) Sampling . Forest shall provide Replidyne with
Product samples reasonably sufficient to permit Replidyne to
perform Detailing calls in accordance with the Marketing Plan.
Replidyne shall be responsible for accounting for sample
distribution by the Replidyne Specialty Sales Force and shall
maintain all records with respect to sample distribution as
required by applicable laws and regulations. Within thirty
(30) days after the end of each month, Replidyne shall provide
to Forest a written report summarizing samples distributed by the
Replidyne Specialty Sales Force for such calendar month. In
addition, Replidyne shall ensure, through appropriate routine
monitoring and auditing standards which conform with current good
industry practices, that sampling of the Product is carried out by
Replidyne in a manner which is in compliance with all Applicable
Laws. Replidyne shall immediately advise Forest of its discovery of
any act or omission of Replidyne regarding sample distribution that
could violate or require reporting under applicable law. Forest
shall be solely responsible for the filing of any necessary reports
to FDA in connection with sampling. Within thirty (30) days
after the expiration or termination of the Replidyne Specialist
Promotion Period, Replidyne shall return, or otherwise dispose of
in accordance with written instructions from Forest, all remaining
samples and will provide Forest with a certified statement that all
remaining samples have been returned or otherwise properly disposed
of in accordance with Forest’s instructions and that
Replidyne is no longer in possession or control of any samples in
any form or fashion.
(e) Funding . Forest will reimburse Replidyne for the
Sales Force Expense and Marketing and Sampling Expense incurred by
Replidyne in the performance of the activities to be conducted by
the Replidyne Specialty Sales Force and ancillary personnel of
Replidyne in accordance with the Marketing Plan, as provided in
Section 7.10 . If Replidyne engages a contract sales
organization rather than hiring its own employees for purposes of
forming the Replidyne Specialty Sales Force, [ *** ] .
Replidyne shall not be obligated to incur expenses for any
marketing or promotional activities directed at Target Specialists,
other than those expenses that are Sales Force Expense and
Marketing and Sampling Expense to be reimbursed by Forest, unless
Replidyne elects in its sole discretion to do so, provided that,
unless Replidyne elects to cease promotional activities to Target
Specialists and to transition such activities to Forest within a
six-month period, Replidyne shall be responsible for the ancillary
costs of the Replidyne Specialty Sales Force which are not Sales
Force Expense. If at any time during the Replidyne
[ *** ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities
Exchange Act of 1933, as amended.
29.
Specialist
Promotion Period, the limits on Forest’s reimbursement of the
Sales Force Expense and Marketing and Sampling Expense as set forth
in Section 7.10 are such that Forest’s funding of
the Replidyne activities directed to Target Specialists falls below
the level sufficient to execute the Marketing Plan with respect to
Target Specialists, except to the extent of the ancillary costs
referred to in the preceding sentence, Replidyne shall not be
obligated to supplement the funding to meet the goals of the
Marketing Plan with respect to Target Specialists.
(f) Additional Support . Forest will offer to
Replidyne, free of charge, but at no additional out-of-pocket cost
to Forest, reasonable access to Forest’s personnel and
technology infrastructure as may be available to provide support
for Replidyne’s marketing and promotion to Target Specialists
(including without limitation, External Scientific Affairs and
trainers, information technology support personnel and personnel
responsible for accounting for sample distribution, database
access, and access to Forest sample ordering systems).
(g) Extension; Termination . The Replidyne Specialist
Promotion Period shall be subject to renewal or extension by the
written agreement of the parties. Replidyne reserves the right to
terminate its promotional efforts under Section 5.4 at
any time during the Replidyne Specialist Promotion Period,
effective upon twelve (12) months written notice to Forest. If
Replidyne exercises the foregoing right, Replidyne shall provide
such transition activities as and for such period as Forest may
reasonably request, including, without limitation, arranging for
meetings between members of the Replidyne Specialty Sales Force and
sales representatives of Forest, to assure a smooth transition of
marketing to Target Specialists, subject to Forest’s payment
of Sales Force Expense and Marketing and Sample Expense incurred by
Replidyne with respect to such transition activities during any
such transition period.
(h) Forest Termination Right . If Forest ceases the
promotion, sale or distribution of the Product in the Territory
under the circumstances permitted under this Agreement, then upon
written notice to Replidyne, Forest may terminate the Replidyne
Specialist Promotion Period, effective within a reasonable period
of time in light of the circumstances underlying any such cessation
by Forest. In addition, Forest reserves the right to terminate the
Replidyne Specialist Promotion Period, effective upon [ ***
] written notice to Replidyne in the event that the Detail
Reports for at least [ *** ] indicate that Replidyne’s
Detailing has not achieved at least [ *** ] percent ( [
*** ] %) of the Detailing to be performed by Replidyne as
targeted by the Marketing Plan (as to number or position of
Details) for each such Calendar Quarter or upon the failure by
Replidyne to achieve at least [ *** ] percent ( [ ***
] %) of the Detailing to be performed by Replidyne as targeted
by the Marketing Plan (as to numbers or portions of Details) in the
aggregate over a period of [ *** ] , unless in either case,
during such [ *** ] period Replidyne develops and implements
a program of increased Detailing which provides, to Forest’s
reasonable satisfaction, assurance that Detail shortfalls will not
again occur. Failure of Replidyne to meet the number of Details
required under the Marketing Plan with respect to promotion efforts
dire
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