EXHIBIT 10.16
[ * ] = 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 24b-2
of the Securities Exchange Act of 1934, as amended.
LICENSE AND COOPERATION AGREEMENT
This
License and Cooperation Agreement (the "Agreement") is made and
entered into this 28 th day of June, 2000, by and
between Merz + Co. GmbH & Co., a limited partnership with a
limited company as its general partner organized and existing under
the laws of Germany, with its principal business office located at
Eckenheimer Landstrasse 100-104, D-60318 Frankfurt/Main, Germany
("Merz"), and Forest Laboratories Ireland Limited, a corporation
organized and existing under the laws of the Republic of Ireland,
with its principal business address located at Clonshaugh
Industrial Estate, Clonshaugh, Dublin 17, Republic of Ireland
("Licensee").
W I T N E S S E T
H:
WHEREAS,
Merz is the owner of certain United States patents for the
application and use of Memantine relating to the treatment of
various forms of dementia, and is currently marketing and
distributing Memantine, under the name "Akatinol Memantine" for the
treatment of such dementia in Germany; and
WHEREAS,
Merz has conducted and is currently conducting clinical trials of
Memantine for the treatment of vascular dementia and Alzheimer's
disease in the United States and Europe; and
WHEREAS,
Licensee wishes to acquire a license to use the Merz patents and
certain Merz know-how for the manufacture, marketing, distribution,
sale and use of the Contract Products (as defined herein) within
the Territory (as defined herein) solely for the treatment of
vascular dementia and Alzheimer's disease; and
WHEREAS,
Merz is willing to grant to Licensee a license to use the Merz
patents and certain Merz know-how for the manufacture, marketing,
distribution, sale and use of the Contract Products, in accordance
with the terms and conditions, and subject to the limitations, of
this Agreement; and
WHEREAS,
the parties wish to define the terms of their cooperation in
securing Regulatory Approvals (as defined herein) for Memantine,
including the Contract Products, for the treatment of vascular
dementia and Alzheimer's disease, and for the marketing and
distribution of the Contract Products within the Territory.
NOW,
THEREFORE, in consideration of the foregoing, the parties to this
Agreement do agree as follows.
Article 1: Definitions
For
purposes of this Agreement, the following terms shall have the
following meanings:
1.1 An
"Affiliate" of one of the parties to this Agreement shall mean and
include any person, firm, corporation or other entity: (i) more
than fifty percent (50%) of the voting stock or other equity
interest is owned, directly or indirectly, by that party; (ii)
which owns, directly or indirectly, more than fifty percent (50%)
of the voting stock or other equity interest of that party; or
(iii) more than fifty percent (50%) of the voting stock or other
equity interest thereof is owned, directly or indirectly, by a
person, firm, corporation or other entity that owns, directly or
indirectly, more than fifty percent (50%) of the voting stock or
other equity interest of that party.
1.2 "Applicable
Laws" shall mean and include all laws, regulations, rules, decrees,
judicial and administrative orders, and governmental actions,
policies and requirements having the force of law in the
Territory.
1.3 Merz'
"Confidential Information" shall mean and include all of the Merz
Know-How, and all other data and information, not in the public
domain, relating to the Contract Products, the Indications, or the
business, affairs, research and development activities, results of
clinical trials, national and multinational regulatory proceedings
and affairs, finances, plans, contractual relationships and
operations of Merz, or to any of Merz' Intellectual Property
Rights.
1.4 The
"Contract Products" shall mean and include all pharmaceutical
products, manufactured by Licensee hereunder, as mono-preparations
and combination preparations, with Memantine as an active
ingredient, for use in any of the Indications, in any form of
administration whatsoever.
1.5 The
"Effective Date" of this Agreement shall mean the day after the
date on which the statutory waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended,
15 U.S.C. ss18a, expires. The parties shall use diligent efforts to
file the required notifications under the Hart-Scott-Rodino
Antitrust Improvements Act with the United States Department of
Justice and the Federal Trade Commission, and to request early
termination of the statutory waiting period, as soon as reasonably
practicable after the date hereof.
1.6 The
"FDA" shall mean the United States Food and Drug Administration, or
any successor agency thereto.
1.7 The
"First Commercial Sale" of the Contract Products in the Territory
shall mean the date on which the Licensee first sells any of the
Contract Products for use in any of the Indications, after
obtaining all of the applicable Regulatory Approvals.
1.8 "Improvements
and Enhancements" to the Contract Products shall mean and include
any and all Inventions, and any and all changes, modifications and
amendments to Merz' Know-How which: (i) improve the performance or
efficacy of the Contract Products; (ii) reduce any side effects,
drug interactions or other adverse effects of the Contract
Products; (iii) reduce the cost and/or increase the efficiency or
productivity of the manufacturing and production processes for the
Contract Products; or (iv) relate to the use of Memantine for the
diagnosis and/or treatment of other indications or applications
excluding: (A) ophthalmological applications; and (B) tinnitus,
except to the extent that Licensee acquires any rights to use
Memantine for either of those indications under Article 2.11
hereof.
1.9 The
"Indications" shall mean the use of the Contract Products for the
treatment (including retarding the onset and progression) of
vascular dementia and Alzheimer's disease and any mixed forms
thereof, and any and all other indications and applications for the
Contract Products and/or Memantine: (i) developed by Licensee
pursuant to Article 2.1 hereof; or (ii) licensed by Merz to
Licensee hereafter, pursuant to Article 2.11 hereof.
1.10 "Inventions"
shall mean and include any and all inventions and discoveries which
are, or may be, patentable or otherwise protectable under the
patent or other intellectual property laws within the Territory,
which relate to the Contract Products, and which are conceived,
discovered or reduced to practice during the continuance of this
Agreement.
1.11 "Intellectual
Property Rights" shall mean and include all patents, as listed on
Exhibit 1.11 hereto, Trademarks, as defined in Article 1.18,
copyrights, data exclusivity rights, trade names and other
proprietary rights relating to, embodied in, or associated with the
Contract Products, and all applications, divisions, continuations,
continuations-in-part, extensions, substitutions, renewals,
confirmations, supplementary protection certificates,
registrations, pipeline registrations, revalidations, reissues and
additions of all patent rights hereunder.
1.12 Merz'
"Know-How" shall mean and include all present and future
specifications, results of clinical trials, technical data and
other information relating to the design, formulation, manufacture,
production, quality control, Regulatory Approvals, distribution,
sale and/or use of Memantine for any of the Indications.
1.13 "Memantine"
shall mean the NMDA antagonist (1-amino-3, 5-dimethyladamantane
hydrochloride), as described in more detail in Exhibit 1.13
hereto, and covered by one or more of the Merz' patents, as listed
on Exhibit 1.11 hereto, including synthetic precursors,
prodrugs, polymorphs and salts thereof.
1.14 Licensee's
"Net Revenues" shall mean and include all gross revenues derived by
Licensee or any of its Affiliates or sublicensees from the
marketing, distribution, sale and/or use of the Contract Products
or any generic versions of Memantine to unrelated third parties, as
determined in accordance with United States generally accepted
accounting principles, consistently applied, less: (i) all bona
fide allowances for returns and discounts actually given to
customers including, but not limited to, rebates, charge backs and
contract administration fees directly related to the marketing,
distribution and sale of the Contract Products; (ii) all costs of
shipping, freight, transportation and insurance for the Contract
Products, but only to the extent that such costs are included in
Licensee's invoice price to its customers for the Contract
Products; and (iii) all sales, use, excise and value added taxes
that are included in Licensee's invoice price to its customers for
the Contract Products.
1.15 "Regulatory
Approvals" shall mean and include all licenses, permits,
authorizations and approvals of, and all registrations, filings and
other notifications to, any governmental agency or department
within the Territory, including, without limitation, the FDA,
necessary or appropriate for the manufacture, production,
marketing, distribution, sale and/or use of the Contract Products
within the Territory.
1.16 The
"Supply Agreement" shall mean that certain Supply Agreement between
the parties, dated June 28, 2000, attached hereto as Exhibit
1.16 , under the terms of which Merz shall supply to Licensee
the active ingredient raw material for the Contract Products.
1.17 The
"Territory" shall mean and include the United States of America,
including its territories, commonwealths and possessions.
1.18 The
Merz "Trademarks" shall mean and include those trademarks and trade
names, specified by Merz, as listed on Exhibit 1.18 hereto,
and any trademarks and trade names proposed by Licensee for use
with the Contract Products, and approved in writing by Merz, which
approval shall not be unreasonably withheld; provided, however,
that, in the event that Merz approves any such trademarks and/or
trade names proposed by Licensee hereunder, Licensee shall assign,
transfer and convey to Merz all rights, title and interests in and
to all such trademarks and trade names, and such trademarks and
trade names shall thereafter be deemed to be included in Merz'
Intellectual Property Rights for all purposes of this
Agreement.
Article 2: Grant and Scope of License
2.1 Merz
hereby grants to Licensee, and Licensee hereby accepts, a limited
license to use Merz' Intellectual Property Rights and Merz'
Know-How to obtain all required Regulatory Approvals, and to
manufacture, produce, market, distribute, sell and use the Contract
Products solely for use in the Indications within the Territory, in
accordance with the terms and conditions, and subject to the
limitations of, this Agreement. The license granted by Merz to
Licensee under this Article 2.1 shall include the right to use
Merz' Intellectual Property Rights and Merz' Know-How in conducting
advanced research and development activities with respect to the
Contract Products and/or Memantine, and to utilize the results of
such advanced research and development activities, including any
Improvements and Enhancements, in accordance with the terms and
conditions, and subject to the limitations, of this Agreement.
2.2 Licensee
shall have a limited right to sublicense any of the rights granted
by Merz to Licensee under this Article 2.1 solely to: (i) one or
more Affiliates of Licensee; or (ii) any other person, firm,
corporation or other entity that has been approved in writing as a
sublicensee by Merz; provided, however, that Merz shall be required
to approve any prospective sublicensee proposed by Licensee
hereunder only where: (A) Merz reasonably determines that the
prospective sublicensee has the financial resources, technical
expertise and marketing and distribution capability to manufacture,
produce, market, distribute and sell the Contract Products in
accordance with the requirements of this Agreement; (B) the
prospective sublicensee is not currently, and will not foreseeably
be a direct competitor of Merz, and is not engaged in pending
litigation, arbitration or other dispute with Merz; and (C) the
prospective sublicensee enters into a written agreement with Merz,
under which the prospective sublicensee agrees to comply strictly
with all of the terms and conditions of this Agreement.
2.3 Licensee's
rights with respect to the licenses to Merz' Intellectual Property
Rights and Merz' Know-How, granted to Licensee under Article 2.1 of
this Agreement, shall be the exclusive right to obtain all required
Regulatory Approvals, and to manufacture, produce, market,
distribute and sell the Contract Products within the Territory, and
the right to manufacture and produce the Contract Products in the
Republic of Ireland, solely for distribution and sale within the
Territory.
2.4 Merz
also hereby grants to Licensee, and Licensee hereby accepts a
limited, exclusive, non-transferable license to use the Merz
Trademarks solely in connection with the manufacture, production,
marketing, distribution, sale and use of the Contract Products for
the Indications within the Territory. Unless otherwise agreed in
writing by Merz, Licensee shall affix the Trademarks to all of the
Contract Products manufactured, produced, marketed, distributed
and/or sold by Licensee under this Agreement.
2.5 Notwithstanding
the provisions of Article 2.4 hereof, in the event that Licensee
reasonably determines that one or more generic drug manufacturers
has introduced, or proposes to introduce, a generic version of
Memantine within the Territory, upon written notice thereof to
Merz, Licensee shall have the right to market, distribute and sell
a generic version of Memantine within the Territory; provided,
however, that Licensee's marketing, distribution and sale of a
generic version of Memantine within the Territory in accordance
with this Article 2.5, shall not affect or impair any of Merz'
rights, or any of Licensee's other obligations, under this
Agreement, unless otherwise agreed in writing by Merz.
2.6 In
furtherance of the rights and license granted by Merz to Licensee
under this Agreement, within thirty (30) days after the Effective
Date of this Agreement, Merz shall furnish to the Licensee a data
package that shall include all of the Merz Know-How existing as of
that Effective Date which, in Merz' reasonable opinion, are
relevant to Regulatory Approvals and compliance with Applicable
Laws, with respect to the Contract Products. Licensee shall not use
any of the Merz Know-How furnished by Merz under this Article 2.6
for any purpose whatsoever, except as specifically authorized in
this Agreement, or as otherwise specifically authorized in writing
by Merz. In the event that Licensee reasonably believes that the
Merz Know-How included in the data package furnished by Merz under
this Article 2.6 is incomplete, Licensee shall provide written
notice thereof to Merz, and Merz shall furnish corrected copies of
such Merz Know-How within thirty (30) days after receipt of
Licensee's written notice hereunder.
2.7 Without
limiting the generality of Articles 2.1, 2.2, 2.3 or 2.6 hereof,
Licensee specifically acknowledges and agrees that the license
granted to Licensee hereunder is limited to the use of the Contract
Products for the Indications within the Territory, and Licensee
shall not knowingly market, distribute, sell or use any of the
Contract Products for any other application or purpose whatsoever,
and shall not actively promote, or solicit orders for, the sale of
the Contract Products outside of the Territory, without the prior
written authorization of Merz, which Merz may grant or withhold in
its sole discretion.
2.8 Licensee
hereby acknowledges that Merz is the owner, or authorized licensee,
of certain additional intellectual property rights and know-how,
relating to the use of Memantine for certain other applications,
including, but not limited to, [ * ] . Licensee further
acknowledges and agrees that it shall have no rights whatsoever
with respect to such other intellectual property rights or
know-how, or to use Merz' Intellectual Property Rights and/or Merz'
Know-How, for any other application, except as specifically agreed
in writing between Merz and Licensee.
2.9 Each
party hereto represents and warrants that the execution, delivery
and performance of this Agreement has been duly authorized by all
necessary corporate action on the part of that party, and do not
conflict with the terms of any other contract, agreement,
arrangement or undertaking to which that party is bound.
2.10 Merz
is the owner of the Merz Patent Rights listed on Exhibit
1.11 hereto, and is the owner or authorized licensee of the
other Merz Intellectual Property Rights and Merz' Know-How, and
Merz has the right to grant the license to such Intellectual
Property Rights and Know-How to Licensee, as provided in this
Agreement. Merz has not received any notice, and has no knowledge,
of any claim by any other person, firm, corporation or other
entity, in which such other person, firm, corporation or other
entity within the Territory asserts that any of Merz' Intellectual
Property Rights are invalid, or infringe the intellectual property
rights of such other person, firm, corporation or other entity.
2.11 In
furtherance of the exclusive rights and license granted by Merz to
Licensee pursuant to this Agreement, Merz shall not, during the
continuance of this Agreement, market, distribute or sell any
pharmaceutical formulations of Memantine, or grant any license or
other authorization to any other person, firm, corporation or other
entity to market, distribute and/or sell any pharmaceutical
formulations of Memantine within the Territory for the Indications
or for any other indication or application, except (i)
ophthalmological applications; and (ii) tinnitus. In the event that
Merz proposes to market, distribute or sell any pharmaceutical
formulation of Memantine, or license or authorize any other person,
firm, corporation or other entity to market, distribute and/or sell
any pharmaceutical formulations of Memantine for any other
indication or application, or in the event that Merz hereafter
acquires the right (including the right to sublicense) to
manufacture, produce, market, distribute and sell any
pharmaceutical formulations of Memantine for any ophthalmological
applications or indications or for tinnitus in the United States
from one or more third parties, Merz shall enter into good faith
negotiations with Licensee with respect to granting Licensee an
exclusive license to manufacture, produce, market, distribute and
sell the pharmaceutical formulations of Memantine within the
Territory for such other indications or applications on mutually
acceptable terms and conditions. In the event that the parties are
unable to conclude such a license agreement for such other
indications or applications, despite good faith negotiations,
within one hundred twenty (120) days of commencing such
negotiations, Merz shall have the right to enter into a license
agreement for such other indications or applications with another
person, firm, corporation or other entity provided that the terms
and conditions of the license agreement with such other person,
firm, corporation or other entity with respect to the Territory are
not more favorable to such other person, firm, corporation or other
entity than the final terms and conditions offered by Merz to
Licensee for the manufacture, production, marketing, distribution
and sale of pharmaceutical formulations of Memantine for such other
indications or applications within the Territory.
2.12 In
furtherance of Licensee's manufacture and production of the
Contract Products under this Agreement, Merz shall supply
Licensee's requirements of Memantine, pursuant to, and in
accordance with the terms and conditions of the Supply Agreement
attached hereto as Exhibit 1.16 .
Article 3: Regulatory Approvals and Compliance with
Applicable Laws and Regulations
3.1 Licensee
shall be responsible for applying for, and shall use its reasonable
best efforts to obtain all required Regulatory Approvals,
including, but not limited to, a new drug application approval,
from the FDA, for the manufacture, production, marketing,
distribution, sale and use of the Contract Products within the
Territory. Except as otherwise provided in this Agreement, or as
required under Applicable Laws, all such Regulatory Approvals,
including, but not limited to, the NDA for the Contract Products
within the Territory shall be held in the name of Licensee. In
furtherance of Licensee's obligations under this Article 3.1, Merz
shall appoint Licensee as Merz' agent with respect to the
Investigational New Drug ("IND") application opened by Merz with
the FDA for Memantine for the Indications prior to the Effective
Date of this Agreement.
3.2 In
the event that the FDA, or any other competent governmental agency
within the Territory, requires any additional clinical trials or
other studies in connection with the processing and consideration
of any application by Licensee for any Regulatory Approval under
Article 3.1 hereof, Licensee shall conduct all such additional
clinical trials and studies, in accordance with Article 3.1 hereof,
and Licensee shall be solely responsible for any and all costs and
expenses incurred in connection with all such additional clinical
trials and studies, and all other costs and expenses incurred in
connection with all applications for all Regulatory Approvals under
Article 3.1 hereof. Licensee shall furnish to Merz the results of
all such additional clinical trials and studies, and copies of all
other documents and materials submitted by Licensee to the FDA, or
any other competent governmental authority, in connection with any
application submitted by Licensee for any Regulatory Approval for
the Contract Products within the Territory.
3.3 The
data package furnished by Merz pursuant to Article 2.6 hereof shall
include: (i) all relevant chemical, manufacturing and quality
control data relating to the Memantine drug substance and the
manufacture thereof in Merz' possession as of the Effective Date of
this Agreement; and (ii) all other data included in the Drug Master
File submitted by Merz or Merz' supplier to the FDA which Merz has
the right to disclose to Licensee. Merz shall be solely responsible
for filing and maintaining, and shall file and maintain, or cause
Merz' supplier to file and maintain the Drug Master File for
Memantine with the FDA, in accordance with the FDA's requirements
and Applicable Laws, and neither Merz nor Merz' supplier shall
modify that Drug Master File in a manner that would have a material
adverse effect on the NDA or any other Regulatory Approval for the
contract Products within the Territory. Merz shall, or shall cause
Merz' supplier to, grant to Licensee a right of reference to that
Drug Master File. Merz shall also furnish Licensee with all
documentation and other assistance as Licensee shall reasonably
request in connection with Licensee's applications for Regulatory
Approvals for the Contract Products pursuant to Article 3.1 hereof;
provided, however, that, in the event that the documentation
included in the data package furnished to Licensee under Article
2.6 is not sufficient to permit Licensee to obtain all such
required Regulatory Approvals, Licensee shall be solely responsible
for preparing all necessary additional documentation, at Licensee's
sole expense, to support Licensee's applications for such
Regulatory Approvals.
3.4 Licensee
shall be solely responsible for maintaining all Regulatory
Approvals issued to Licensee, pursuant to Article 3.1 in full force
and effect throughout the continuance of this Agreement. Licensee
shall furnish Merz with timely written notice of (i) each
application submitted by Licensee for any Regulatory Approval for
the Contract Products hereunder; (ii) the issuance of any such
Regulatory Approval; and (iii) the renewal, extension, modification
or revocation of any such Regulatory Approval.
3.5 In
the event that Licensee fails to take the following actions
relating to obtaining Regulatory Approvals for the Contract
Products, as to the manufacture, production, distribution,
marketing and sale of the Contract Products in the Territory by the
following completion dates, Licensee shall pay to Merz the
following performance penalties:
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Milestone
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Completion
Date
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Performance
Penalty
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a.
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Licensee's delivery of clinical supplies (including medications,
study protocols and all relevant documentation) to first
investigators in Additional Pivotal Phase III Clinical Trials in
the Territory, if required by the FDA
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Four (4) months after (i) FDA approval of the study protocol for
these Phase III Clinical Trials, and (ii) availability of packaged
clinical supplies meeting FDA regulatory requirements for study
use
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[ * ] for each complete calendar month after the
scheduled completion date, until completion of this Milestone
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b.
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Filing of initial application with the FDA for New Drug
Application ("NDA") Regulatory Approval of the Contract Products
for the Indications
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(i) In the event that the FDA does not require any additional
clinical studies prior to the submission of Licensee's application
for the NDA Regulatory Approval, fifteen (15) months after the
later to occur of: (A) Licensee's meeting with the FDA at which the
FDA informs Licensee that no such additional clinical studies are
required; or (B) the receipt by Licensee from Merz of all data
specified in Article 3.3 hereof.
(ii) In the event that the FDA does require additional clinical
studies prior to the submission of Licensee's application for the
NDA Regulatory Approval, nine (9) months after the later to occur
of: (A) the completion of the last required clinical study,
including Licensee's receipt of statistical analyses in a form
appropriate for submission to the FDA; and (B) the receipt by
Licensee from Merz of all data specified in Article 3.3 hereof.
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[ * ] for each complete calendar month after the
scheduled completion date, until completion of this Milestone
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c.
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First Commercial Sale of the Contract Products for the
Indications in the Territory
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Within four (4) months after issuance of all required Regulatory
Approvals, including approval of the final packaging, labeling and
Licensee's initial marketing materials for the Contract
Products
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[ * ] , for each complete calendar month after the
scheduled completion date, until completion of this Milestone
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3.6 In
the exercise of its rights, and the performance of its obligations
under this Agreement, including, but not limited to, the
manufacture, production, marketing, distribution, sale and use of
the Contract Products, Licensee shall comply with all Applicable
Laws, and with all applicable Regulatory Approvals. Without
limiting the generality of this Article 3.6, all Contract Products
manufactured, produced, marketed, distributed or sold by Licensee
under this Agreement shall be packaged and labeled strictly in
accordance with such Applicable Laws and Regulatory Approvals.
3.7
(a) Each of the parties hereto
shall disclose to the other party all safety reports and other
information (collectively "Safety Data") which they may from time
to time receive or obtain (whether from sources within or without
the Territory) with respect to any adverse drug experiences with
respect to the Contract Products, in accordance with the following
timelines after receipt of such Safety Data by that party:
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(i)
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within five (5) calendar days -- all reports of serious adverse
events from clinical studies with a seriousness determination of
"death" or "life-threatening";
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(ii)
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within ten (10) calendar days -- all reports of serious adverse
events from clinical studies with a seriousness determination other
than "death" or "life threatening";
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(iii)
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within ten (10) calendar days -- all serious spontaneously
reported adverse events involving the Contract Products from any
source, including, but not limited to, medical literature; provided
that any and all such reports shall be in the language of original
publication, and an English language translation thereof, if
applicable, shall be furnished as soon as reasonably practicable
thereafter;
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(iv)
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two (2) weeks prior to the regulatory reporting date for any NDA
Adverse Event Periodic Report, as provided under Applicable Law --
copies of all reported non-serious adverse drug reactions of United
States origin;
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(v)
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Licensee shall provide Merz with copies of the IND Annual Report
prepared by Licensee with respect to the Contract Products two (2)
weeks prior to the time that Licensee submits that IND Annual
Report to the FDA.
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(b) Each party shall cause each
of its licensees or sublicensees, as the case may be, to disclose
to it any and all Safety Data which that licensee or sublicensee
may from time to time receive or obtain, in accordance with the
time lines set forth in Article 3.7(a) hereof, and each party shall
disclose to the other party hereto all Safety Data reported to it
by any such licensee or sublicensee, as the case may be, within the
number of days after receipt thereof from that licensee or
sublicensee as specified in Article 3.7(a) hereof; provided,
however, that, in all events, each party shall require its
licensees or sublicensees, as the case may be, to report all such
Safety Data to it so as to assure that both Merz and Licensee may
comply strictly with all Safety Data reporting requirements with
respect to the Contract Products established by Applicable Law
and/or any applicable Regulatory Approvals.
(c) Each party shall promptly
deliver to the other party hereto a copy of all correspondence and
other communications which that party may receive from any
government agency or department, whether within or without the
Territory, relating to the Contract Products; provided, however,
that the parties' respective obligations under this Article 3.7(c)
shall not apply to procedural, non-substantive communications from
any such governmental agency or department that do not relate to
the safety of the Contract Products. Without limiting the
generality of this Article 3.7(c), each party shall furnish to the
other party hereto copies of the following Drug Safety Report
submissions, as required under Applicable Law, prior to the
delivery of such Drug Safety Report submissions to the competent
governmental health or regulatory agency or department:
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(i)
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all applicable United States FDA Adverse Event Periodic Reports
involving the Contract Products;
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(ii)
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all international Periodic Safety Update Reports involving the
Contract Products;
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(iii)
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all Medical Expert Safety Reports requested or required by any
such governmental health or regulatory agency or department for the
renewal of any Regulatory Approval for the Contract Products;
and
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(iv)
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any information requiring, or justifying, any changes to the
safety section of the International Core Label, or the United
States Product Information, for the Contract Products.
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(d)
All Safety Data, reports and
other communications required to be furnished by each party to the
other party under this Article 3.7 shall be delivered in accordance
with the notice procedures set forth in Article 13.4 hereof.
3.8 Each
party shall provide the other party hereto with such assistance as
the other party shall reasonably request in connection with the
identification, analysis, mitigation and elimination of all such
side effects, drug interactions and other adverse effects with
respect to the Contract Products; provided, however, that, in the
event that Licensee is required by the FDA or any other competent
governmental agency to undertake any clinical trials or additional
studies with respect to any such side effects, drug interactions or
other adverse effects of the Contract Products, in order to
maintain the Regulatory Approvals for such Contract Products,
Licensee shall be solely responsible for performing such clinical
trials or additional studies, at its sole expense.
Article 4: Licensee's Obligations
4.1 Licensee
shall use its best efforts to market, distribute and sell the
Contract Products in the Territory, in order to maximize the Net
Revenues derived from such Contract Products throughout the
continuance of this Agreement. Without limiting the generality of
Licensee's best efforts obligation under this Article 4.1, Licensee
shall:
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a.
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apply for all required Regulatory Approvals as soon as
reasonably practicable, in accordance with the provisions of
Article 3.1 hereof;
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b.
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make the First Commercial Sale of the Contract Products in the
Territory within one hundred twenty (120) days after the date on
which all of the Regulatory Approvals required for the marketing,
distribution, sale and use of the Contract Products are issued by
the FDA or any other competent government agency, including
approval of the final packaging, labeling and Licensee's initial
marketing materials for the Contract Products; and
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c.
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not manufacture, produce, market, distribute or sell any
products which are directly competitive with the Contract Products,
to the extent that any such activities would involve the use of any
of Merz' Intellectual Property Rights, Merz' Know-How or any other
Merz Confidential Information, or would be otherwise inconsistent
with any of Licensee's obligations under this Agreement.
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4.2 In
the event that Licensee breaches any of its obligations under
Article 4.1(c) hereof, with respect to the manufacture, production,
marketing, distribution and/or sale of competitive products, Merz
shall have the right to convert the exclusive and sole license
rights provided for in Article 2.3 hereof into non-exclusive
license rights, by furnishing written notice thereof to Licensee.
In the event that Merz elects to exercise its rights under this
Article 4.2, upon Merz' written request, at Merz' sole option,
Licensee shall: (i) transfer to Merz all Regulatory Approvals
applicable to the Contract Products; or (ii) provide Merz with any
and all documents, materials, clinical studies, test reports and
other information, and shall provide Merz with all assistance
reasonably requested by Merz, in order to permit Merz to apply for,
and obtain, duplicate Regulatory Approvals for the Contract
Products.
4.3 All
of the Contract Products manufactured or produced by Licensee shall
be manufactured with Memantine as the active ingredient, strictly
in accordance with Merz' Intellectual Property Rights and Merz'
Know-How, as licensed to Licensee hereunder, and in accordance with
any and all other standards, specifications, quality assurance
procedures, manufacturing practices and requirements set forth in
all applicable Regulatory Approvals. In furtherance of Licensee's
obligations under this Article 4.2, upon Merz' written request,
Licensee shall:
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a.
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provide Merz with written notice of Licensee's initial
manufacture and production of the Contract Products, and permit
Merz to inspect and test such initial Contract Products, in order
to confirm that such initial Contract Products conform to the
requirements of all applicable Regulatory Approvals and Merz'
standards and requirements for the usage of the Trademarks;
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b.
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permit Merz to inspect Licensee's manufacturing facilities and
operations for the Contract Products, in order to confirm that such
facilities and operations conform to good manufacturing practices
and to Merz' Know-How for such Contract Products; and
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c.
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furnish Merz with a reasonable quantity of samples of the
Contract Products, from time to time during the continuance of this
Agreement, in order to permit Merz to confirm that such Contract
Products continue to conform to Merz' standards and requirements
for the usage of the Trademarks.
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4.4 In
the event that Merz reasonably determines that any of the Contract
Products and/or Licensee's manufacturing facilities and operations
do not conform to the requirements of Article 4.3 hereof, Merz
shall give notice thereof, specifying all such deficiencies in the
Contract Products or Licensee's manufacturing facilities and
operations, as the case may be. Licensee shall take corrective
action to remedy all such deficiencies in the Contract Products
and/or Licensee's manufacturing facilities and operations, as the
case may be, immediately upon receipt of such written notice from
Merz. Upon completion of all such corrective action, Licensee shall
furnish Merz with a reasonable number of samples of the Contract
Products, and shall permit Merz to inspect Licensee's manufacturing
facilities and operations, in order to confirm that all such
deficiencies have been corrected.
4.5 Attached
hereto as Exhibit 4.5 is Licensee's sales forecast for Net
Revenues to be derived by Licensee from the distribution and sale
of the Contract Products within the Territory during each of the
first three (3) twelve-month periods following the First Commercial
Sale of the Contract Products within the Territory. At least ninety
(90) days prior to the start of each year after the expiration of
that initial three (3) year period during the continuance of this
Agreement, Licensee shall furnish to Merz Licensee's detailed sales
plan for the marketing, distribution and sale of the Contract
Products in the Territory for the coming year.
4.6 The
parties shall use their best efforts to collaborate in the
marketing and promotion of the Contract Products in the Territory.
In furtherance of the parties' obligations under this Article 4.6,
the parties shall form a joint marketing committee, comprised of
two representatives from each of the parties. The joint marketing
committee shall meet at least twice every calendar year, and shall
cooperate in coordinating all joint marketing and promotional
activities for the Contract Products in the Territory, including,
but not limited to:
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a.
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the preparation and distribution of scientific and technical
information and promotional materials with respect to the Contract
Products;
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b.
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the organization, participation and conduct of research
seminars, conferences and trade shows; and
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Each party shall provide the other party hereto with written
notice of its two representatives for the joint marketing committee
within ninety (90) days after the Effective Date of this
Agreement.
4.7 Licensee
shall furnish Merz with quarterly reports of all of Licensee's
sales under this Agreement. Each such quarterly report shall (i) be
furnished to Merz within forty-five (45) days after the close of
the calendar quarter to which it corresponds; and (ii) state
Licensee's total sales of the Contract Products during the calendar
quarter, the Net Revenues derived by Licensee from all sales, and
the royalties payable by Licensee to Merz with respect to such Net
Revenues, in accordance with the provisions of Article 5.4 of this
Agreement.
4.8 Throughout
the continuance of this Agreement, Licensee shall keep Merz
informed of all material marketing plans and strategies, including,
but not limited to, sales forecasts, market analyses and proposed
advertising and promotional campaigns and programs, for the
marketing, distribution and sale of the Contract Products in the
Territory.
Article 5: Consideration
5.1 In
consideration for the rights and licenses granted by Merz to
Licensee under this Agreement, Licensee shall make the following
lump sum payments to Merz:
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a.
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[ * ] on the Effective Date of this Agreement.
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b.
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[ * ] upon completion of the pre-NDA Meeting between
Licensee and the FDA, if the FDA indicates that it will be possible
to obtain all required Regulatory Approvals for the Contract
Products with the existing data from clinical trials and studies;
or [ * ] upon completion of that pre-NDA Meeting, if the FDA
requires additional pivotal phase III clinical trials, as a
condition for processing Licensee's application for Regulatory
Approvals for the Contract Products.
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c.
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[ * ] upon issuance of the Regulatory Approvals by the
Food and Drug Administration for the Contract Products for the
Indications in the Territory.
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5.2 All
fees payable by Licensee to Merz under Article 5.1 hereof and any
performance penalties payable by Licensee under Article 3.5 hereof,
are non-refundable upon expiration or termination of this Agreement
for any reason whatsoever. None of the fees payable by Licensee to
Merz under Article 5.1 or performance penalties payable by Licensee
under that Article 3.5 may be credited against any of Licensee's
royalty obligations under Article 5.3 hereof.
5.3 As
further consideration for the rights and licenses granted by Merz
to Licensee under this Agreement, Licensee shall pay royalties to
Merz equal to [ * ] of Licensee's Net Revenues derived from
the distribution and sale of the Contract Products to customers
located within, or for use within, the Territory; provided,
however, that all Memantine for the Contract Products supplied by
Merz to Licensee under the Supply Agreement shall be supplied by
Merz to Licensee at no additional charge therefor.
5.4 Notwithstanding
the provisions of Article 5.3 hereof, in the event that, during the
continuance of this Agreement and thereafter, Licensee markets,
distributes and sells a generic version of Memantine pharmaceutical
products within the Territory, in accordance with the provisions of
Article 2.5 hereof, so long as Merz is willing to supply Licensee's
requirements of raw materials, pursuant to the Supply Agreement,
Licensee shall pay royalties to Merz with respect to Net Revenues
derived from the distribution and sale of such generic version of
Memantine as follows, in lieu of the royalties provided for in
Article 5.3 hereof:
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Licensee's Net
Sales Price
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Royalty
Rate
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a.
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If Licensee's Net Sales Price for the generic version of
Memantine is at least [ * ] of Licensee's Net Sales Price
for the branded Contract Products
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[ * ] of an amount equal to (i) Licensee's then
prevailing Net Sales Price per unit of the branded Contract
Products, multiplied by (ii) the number of units of the generic
version of Memantine sold by Licensee, or any of its sublicensees,
during the applicable calendar quarter.
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b.
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If Licensee's Net Sales Price for the generic version of
Memantine is at least [ * ] of Licensee's Net Sales Price
for the branded Contract Products
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[ * ] of an amount equal to (i) Licensee's then
prevailing Net Sales Price per unit of the branded Contract
Products, multiplied by (ii) the number of units of the generic
version of Memantine sold by Licensee, or any of its sublicensees,
during the applicable calendar quarter.
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c.
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If Licensee's Net Sales Price for the generic version of
Memantine is at least [ * ] of Licensee's Net Sales Price
for the branded Contract Products
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[ * ] of an amount equal to (i) Licensee's then
prevailing Net Sales Price per unit of the branded Contract
Products, multiplied by (ii) the number of units of the generic
version of Memantine sold by Licensee, or any of its sublicensees,
during the applicable calendar quarter.
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d.
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If Licensee's Net Sales Price for the generic version of
Memantine is less than [ * ] of Licensee's Net Sales Price
for the branded Contract Products
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[ * ] Licensee shall purchase its requirements of bulk
Memantine for such generic Memantine pharmaceutical products, in
accordance with the Supply Agreement, at a price per kilogram
specified by Merz, provided that that price per kilogram does not
exceed the price per kilogram offered to Licensee by another
person, firm, corporation or other entity for comparable quantities
of bulk Memantine of comparable quality
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For purposes of this Article 5.4, Licensee's "Net Sales Price"
shall mean the Net Revenues derived by Licensee, or any of
Licensee's sublicensees, as the case may be, from the sale of the
generic version of Memantine, or the branded Contract Products, as
the case may be, divided by the number of units of such products
from which such Net Revenues were derived, as determined on a
quarterly basis. Nothing in this Article 5.4 shall affect or impair
Licensee's obligation to pay, and Merz' right to receive, royalties
with respect to the branded Contract Products as provided in
Article 5.3 hereof.
5.5 In
the event that the royalties payable by Licensee to Merz, as
determined in accordance with the provisions of Article 5.3 hereof,
in any twelve (12) month period during any of the first three (3)
years commencing with Licensee's First Commercial Sale of the
Contract Products are less than [ * ] of an amount equal to
[ * ] of Licensee's annual sales forecast for that twelve
(12) month period as furnished by Licensee to Merz pursuant to
Article 4.5 hereof, multiplied by the applicable royalty rate, as
set forth in Article 5.3 hereof, or Article 5.4 hereof, as the case
may be (the "Minimum Royalty"), Licensee shall pay to Merz an
amount equal to the difference between the Minimum Royalty for that
twelve (12) month period and the royalties actually paid by
Licensee with respect to that twelve (12) month period, within
forty-five (45) days after the close of that twelve (12) month
period. Licensee shall be entitled to a credit f