EXHIBIT 10.1
THE SYMBOL ‘*’ IS
USED THROUGHOUT THIS EXHIBIT TO INDICATE THAT A PORTION OF THE
EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
LICENSE AND COOPERATION
AGREEMENT
This License and Cooperation
Agreement (the “Agreement”) is made and is effective as
of this date of April 16, 1998 (“Effective Date”),
between
Merz + Co. GmbH & Co., a
company organized under the laws of Germany, with its principal
place of business at Eckenheimer Landstrase 100-104, 60318
Frankfurt a. M., Germany (“Merz”),
and
Neurobiological Technologies Inc., a
company organized under the laws of the State of Delaware, U.S.A.,
with its principal place of business at 1387 Marina Way South,
Richmond, CA 94804, U.S.A., (“NTI”),
and
Children’s Medical Center
Corporation, a non-profit organization organized under the laws of
the State of Massachusetts with its principal place of business at
300 Longwood Avenue, Boston, Massachusetts, U.S.A.,
(“CMCC”),
in reference to the following
facts:
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A.
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Merz holds
certain patent rights for the use of Memantine to treat cerebral
ischemia and dementia relating to Alzheimer’s disease (as
further defined in Exhibit B of this Agreement), and is further
developing Memantine for the treatment of dementia and other
diseases.
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B.
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NTI is the
licensee of certain patent rights in Memantine for the treatment of
neuropathic pain and AIDS related dementia and of other patent
rights pertaining to Memantine licensed by CMCC on an exclusive
basis in the field of use as defined in the Exclusive License
Agreement entered into on September 11, 1995 between CMCC and
NTI (hereinafter referred to as the “Exclusive License
Agreement”).
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C.
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CMCC is the
owner of certain patent rights to be further specified in Exhibit
A, including patent rights in Memantine for the treatment of
neuropathic pain and AIDS related dementia.
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D.
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In view of the
cooperation between the parties under this Agreement, which will
succeed the Exclusive License Agreement, CMCC and NTI will
terminate their Exclusive License Agreement on the Effective Date
of the Agreement, without any further obligations under that
Exclusive License Agreement. CMCC and NTI will grant mutual
releases with respect to any obligations under the Exclusive
License Agreement. The termination of the Exclusive License
Agreement shall be a condition precedent to Merz’ obligation
to execute and perform this Agreement.
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E.
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CMCC desires to
have the CMCC Patents, as hereinafter defined, utilized in the
public interest and is willing to grant a license thereunder on the
terms and conditions herein.
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F.
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NTI and Merz
desire to combine their efforts to most efficiently market and
license the Products in the Territory (as hereinafter defined) in
accordance with the terms and conditions of this
Agreement.
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G.
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The parties
believe that the cooperation among the parties as provided under
this Agreement is in their best interest and is the most efficient
and effective way to commercialize the CMCC Indications and the
Merz Indication as hereinafter defined.
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Now, therefore, in consideration of
the promises and the mutual covenants contained herein, the parties
agree as follows:
Article
1—Definitions
1.1 “CMCC Indications”
shall mean the use of the Product within the scope of the CMCC
Patents.
1.2 “CMCC Patents” shall
mean all of the following intellectual property rights:
(i) The United States and foreign
patents and/or patent applications listed in Exhibit A hereto,
including any patents or patent applications, divisionals and
continuations thereof;
(ii) The United States and foreign
patents issued from the applications listed in Exhibit A hereto and
from divisionals and continuations of those
applications;
(iii) Claims of United States and
foreign continuation-in-part applications, and resulting patents,
which relate to subject matter specifically described in the United
States and foreign patent applications described in Exhibit A
hereto;
(iv) Claims of all after filed
foreign patent applications, and of the resulting patents, which
relate to subject matter specifically described in the United
States patent and/or patent applications described in subparagraphs
(i), (ii) or (iii) of this Article 1.2; and
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(v) Any reissues, divisionals,
amendments or extensions of the United States or foreign patents
described in subparagraphs (i), (ii), (iii) or (iv) of
this Article 1.2.
It is further understood that
certain patents listed in Exhibit A hereto related to nitrosylating
compositions, including nitrosomemantine, are not included in the
CMCC Patents.
1.3 “Confidential
Information” shall mean and include any and all data and
information not in the public domain, including know-how and trade
secrets relating to, or contained or embodied in the products,
technology, services, business, finances, or affairs of any party.
Confidential Information may be communicated orally, visually, in
writing or in any other recorded or tangible form. Subject to the
provisions set forth in Article 12.1 with respect to CMCC, all data
and information hereunder will be considered to be Confidential
Information (i) if the disclosing party has marked them as
such, (ii) if the disclosing party has, orally or in writing,
advised the receiving party of their confidential nature, or
(iii) if, due to their character or nature, a reasonable
person in a like position and under like circumstances would treat
them as confidential.
1.4 “Compound” shall
mean any raw material necessary for the manufacturing of the
Products.
1.5 “First Commercial
Sale” shall mean the date on which Merz first sells bulk
Memantine, Products, or finished Products to a Marketing Partner or
to any other Person for any of the Indications governed by this
Agreement in a particular jurisdiction or receives Royalty Income
from any Marketing Partner with respect to the sale of the Products
in a particular jurisdiction.
1.6 “Indication” shall
mean the use of the Product for potential diagnosis and treatment
of diseases and conditions in human beings, except for
ophthalmologic diseases.
1.7 “Intellectual Property
Rights” shall mean and include all patents, copyrights,
trademarks, trade names, or any other proprietary rights which the
parties may own, adopt, use or register and which relate to, are
embodied in, or are associated with any of the Products and/or any
applications or registrations therefor.
1.8 “Marketing
Partner(s)” shall mean any other Person with whom Merz enters
into an agreement for the development, manufacture, marketing
and/or distribution of the Products for any of the CMCC Indications
and/or the Merz Indication.
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1.9 “Merz Indication” shall mean the
use of the Product for potential treatment of dementia relating to
Alzheimer’s disease.
1.10 “Merz Patents”
shall mean the patent rights listed in Exhibit B hereto.
1.11 “Person” shall mean
and include any individual, corporation, trust, estate,
partnership, joint venture, company, association, governmental
bureau or agency, or other entity regardless of its type or
nature.
1.12 “Product(s)” shall
mean (i) Memantine for the Indications neuropathic pain, AIDS
related dementia and any other Indications developed or patented by
CMCC and/or NTI, or licensed to CMCC and/or NTI, (ii) any
other adamantan derivative developed and/or patented by CMCC and/or
NTI and/or licensed to CMCC and/or NTI for the Indication
neuropathic pain, AIDS related dementia and/or other
neurological/neuropsychiatric Indications, (iii) any
combination product which includes Memantine developed or patented
by CMCC and/or NTI and/or licensed to CMCC and/or NTI, and
(iv) Memantine for the Indication of dementia relating to
Alzheimer’s disease, as developed by the parties heretofore
and in the future.
1.13 “Representative”
shall mean all partners, shareholders, officers, directors and
employees of a party to this Agreement.
1.14 “Royalty Income”
shall mean any royalty income derived from any license, development
and/or marketing agreement for Products between Merz and any
Marketing Partner as contemplated in this Agreement; provided,
however, that “Royalty Income” shall not include any
revenues from the supply and sale of Compound to any such Marketing
Partner as set forth in Article 9 hereof, and shall not include any
down-payments, lump-sum payments and/or milestone payments as
specified in Article 8.5 hereof.
1.15 “Territory” shall
mean the worldwide territory, unless otherwise expressly specified
in this Agreement.
1.16 “Trademark” shall
mean the designs, logos, marks, names and service marks used for
the Product.
Article 2—Representation
and Warranties
Each party represents and
warrants:
2.1 That it possesses full power and
authority to enter into this Agreement and to perform the
obligations hereunder;
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2.2 That its Representative whose signature is
affixed hereto has been fully authorized to sign this
Agreement;
2.3 That upon its Effective Date,
the provisions of this Agreement shall constitute its legal, valid
and binding obligations enforceable in accordance with these
terms;
2.4 That it has no agreement with
any other Person nor any other conflict that would preclude it from
fully complying with its obligations under this Agreement and/or
any applicable law or regulations, and that all required consents
of any and all third parties, if any, to enter into this Agreement
and perform the obligations hereunder, have been obtained prior to
the execution of the Agreement; provided, however, that the parties
hereby acknowledge that no party has obtained any approval by or
from the United States Food and Drug Administration for the sale,
distribution and/or use of the Products in the Territory prior to
the execution of this Agreement. Each party shall, at its sole
expense, defend and hold one or both of the other parties and its
Representatives harmless from any liabilities or actions brought
against one or both of the other parties, if and to the extent such
liabilities or actions are based on a claim that (i) the first
party breached an agreement with any other Person for the marketing
and licensing of the Product, or (ii) the first party
misappropriated any trade secret or improperly disclosed any
Confidential Information of any other Person; and
2.5 Without limiting the generality
of the foregoing, CMCC hereby specifically represents and warrants
that as of the Effective Date, to the best knowledge of the CMCC
Technology Transfer Office, it alone owns the CMCC Patents, and
that the CMCC Patents (i) have been duly registered as
described in Exhibit A hereof, and (ii) have not been
abandoned. CMCC further warrants and represents that the CMCC
Technology Transfer Office has no knowledge of any pending or
threatened claims of infringement and has not received any notice
of any claim of infringement from any third party regarding the use
of Memantine or any adamantan derivatives.
Article 3—Purpose and Scope
of Cooperation
3.1 The purpose of the cooperation
among the parties is [the performance of clinical trials, securing
of regulatory approval, and] the development and commercialization
of Products within the Territory, including but not limited to the
marketing and licensing of the parties’ respective
Intellectual Property Rights for the manufacture, distribution,
sale and use of the Products throughout the Territory in accordance
with the terms and conditions of this Agreement. In furtherance of
this purpose, Merz shall be responsible for identifying one or more
suitable Marketing Partners for the Products in the Territory in
accordance with Article 3.2.
3.2 The Parties hereby agree that
one (1) suitable Marketing Partner for the Merz Indication and the
CMCC Indications should be identified. The parties hereby
expressly
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acknowledge that in view of the anticipated
market share and the amount of the currently available pre-clinical
and clinical data, the search for a suitable Marketing Partner will
initially focus on a Marketing Partner for the development and
marketing of Memantine for the Merz Indication; provided, however,
that all reasonable efforts shall be made to find one
(1) Marketing Partner for all Indications covered by this
Agreement, in accordance with Article 10 hereof. If, despite
Merz’ reasonable commercial efforts, it is not possible to
find one (1) Marketing Partner for the development of all such
Indications, commercially reasonable efforts shall be employed to
cooperate with such Marketing Partner to identify one or more
additional Marketing Partners for the development of Memantine for
the other Indications, in accordance with Article 10
hereof.
3.3 The parties acknowledge that it
is in their best interest to expeditiously pursue the marketing and
licensing opportunities for the Products in the Territory as set
forth in this Agreement. Merz and NTI will therefore commit
sufficient personnel, efforts and resources to this cooperation
project to achieve the objectives of this Agreement, as reasonably
determined by Merz.
3.4 Subject to Articles 7.3 and 10.1
and notwithstanding Article 3.1 hereof, nothing in this Agreement
shall be construed to impose on any one of the parties the
obligation to (i) perform joint development work with respect
to the Products or any derivatives of the Products;
(ii) assist any of the other parties in obtaining financing
and funding for its research and development work; or
(iii) engage in any sales activities for the Products in the
Territory other than the activities expressly set forth in this
Agreement.
3.5 The relationship of the parties
established by this Agreement is one of independent contractors,
and nothing in this Agreement shall be construed as giving any one
of the parties the power to direct or control the daily activities
of any other party, to constitute the parties as principal and
agent, employer and employee, or partners. Neither one of the
parties shall have any right, power or authority to act on behalf
of, or bind, any of the other parties, and neither one of the
parties shall represent to any third party that it has such right,
power or authority, except as contemplated herein.
Article 4—License
Grant
4.1 Subject to the provisions of
this Article 4.1 and Articles 4.4 and 4.5 hereof, CMCC hereby
grants to and Merz hereby accepts from CMCC the exclusive and fully
transferable and/or sublicenseable license to CMCC Patents, as
listed in Exhibit A hereto, to develop, make, have made, use and
market the Products in the Territory in accordance with the terms
and conditions described in this Agreement. Subject to Article 10
hereof, Merz shall have the right, at its sole option, to further
research and develop, or to conduct or have conducted further
clinical studies, regarding Memantine for the CMCC Indications.
Merz shall use its commercially reasonable efforts to require any
Marketing Partner who manufactures Products as they pertain to the
CMCC Indications for the sale
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in the United States of America to substantially
manufacture such Products in the United States of America.
Notwithstanding the exclusive license granted to Merz under this
Article 4.1, Merz hereby acknowledges that CMCC has granted a
license to Allergan to utilize certain of the CMCC Patents solely
in connection with Indications for ophthalmologic diseases. The
license granted hereunder shall not be construed to confer upon
Merz by implication, estoppel, or otherwise any rights as to any
technology not governed by CMCC Patents.
4.2 NTI hereby grants an exclusive
and fully transferable or sublicenseable license to Merz, and Merz
hereby accepts such license, to use all of NTI’s Confidential
Information related to and/or required for the commercial
exploitation of the Products in the Territory; provided, however,
that such license shall not include any Confidential Information
relating to the general business information and financial
information of NTI.
4.3 Subject to the obligations set
forth in Article 10.1 hereof, Merz shall have the right to engage
NTI’s services to further research and develop and to conduct
further clinical studies on Memantine for the CMCC Indications on
terms to be mutually agreed upon.
4.4 Notwithstanding anything herein
to the contrary, CMCC shall retain a royalty-free, non-exclusive,
irrevocable license to practice, and to sublicense other non-profit
organizations to practice, the CMCC Patents it owns for
non-commercial research purposes only. Merz shall not assert any
claim of infringement of the Merz Patents against CMCC or any such
non-profit organization, sublicensed by CMCC pursuant to this
Article 4.4, provided that the CMCC Patents are utilized for
non-commercial research purposes only.
4.5 Notwithstanding the provisions
of Article 4.1 hereof, the license granted hereunder to Merz shall
be subject to the rights of the United States government, if any,
under Public Laws 96-517, 97-226, and 98-620, codified at 35 U.S.C.
sec. 200-212 and regulations promulgated thereunder.
Article 5—Merz’
Responsibilities and Obligations
5.1 Merz shall have the exclusive
right and the obligation to use commercially reasonable efforts to
promote and market the Products for the Merz Indication as well as
the CMCC Indications in the Territory and to identify one or more
Marketing Partners for the development of these Indications in
accordance with Articles 3.2 and 10.3 hereof.
5.2 The parties hereby expressly
acknowledge that Merz has entered into marketing arrangements,
license agreements and/or has business plans for the marketing,
licensing and commercial exploitation of the Products for the Merz
Indication in (i) Austria, Germany, Switzerland,
(ii) Japan, and (iii) other countries as listed in
Exhibit F and that the rights conferred upon Merz’ licensees
under those marketing and/or license
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agreements shall remain unaffected by this
Agreement. Notwithstanding the inclusion of the foregoing countries
in the Territory and subject to Exhibit C, Merz shall have no
obligation whatsoever hereunder to NTI and/or CMCC, including the
sharing of Royalty Income, down-payments, lump-sum payments and/or
milestone payments, with respect to any such marketing, licensing
or the commercial exploitation of Products for the Merz Indication,
in any of the foregoing countries.
5.3 Merz shall have the right to
refer to this cooperation in connection with its negotiation of
development, licensing and marketing agreements with Marketing
Partners for Products for the Merz Indication and/or the CMCC
Indications as provided for in this Agreement.
5.4 Merz hereby acknowledges that
CMCC has licensed certain of the CMCC Patents to Allergan for use
solely in the ophthalmologic field of use. It is the intent of CMCC
that each of Merz and Allergan focus its commercial development
efforts within its respective field of use. Merz has requested that
CMCC provide Merz with the name, address, and description of the
field of use of Allergan and the name and telephone number of the
principal contact of Allergan within thirty (30) days of the
Effective Date. Merz and CMCC agree that the provisions of Exhibit
E hereto shall govern the interaction and communication between
Merz and Allergan. To ensure that both Merz and Allergan are aware
of these reciprocal provisions, CMCC shall make a copy of this
Article 5.4 and Exhibit E available to Allergan, and CMCC shall
provide copies of the corresponding provisions of its agreement
with Allergan available to Merz, within twenty (20) days after
the Effective Date.
Article 6—CMCC’s
Responsibilities and Obligations
6.1 CMCC hereby authorizes NTI to
provide Merz with any CMCC Confidential Information pertaining to
and relevant for the commercial exploitation of the patent rights
in Memantine for the CMCC Indications as previously provided by
CMCC to NTI.
6.2 CMCC shall not, through its
Technology Transfer Office or Public Affairs Office, or in any
other official communication, without the prior written consent of
Merz, (i) provide any information to any other Person
regarding the capabilities, performance or use of the Products for
any of the CMCC Indications; or (ii) make any representations
to any other Person that Merz and/or the Marketing Partner has
endorsed, warranted or guaranteed the Products for any of the CMCC
Indications.
Article 7—NTI’s
Responsibilities and Obligations
7.1 Subject to the provisions of
this Agreement, NTI shall use commercially reasonable efforts,
consistent with its financial and technical resources, to actively
support Merz in the marketing of the Products in the Territory to
Marketing Partners and
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licensees, including but not limited to
(i) evaluating marketing and licensing opportunities;
(ii) initiating contacts with potential Marketing Partners,
and (iii) upon Merz’ request, assisting in the
negotiation of marketing and licensing agreements.
7.2 NTI shall provide to Merz within
thirty (30) days of the Effective Date a data package with all
Confidential Information pertaining to and relevant for the
commercial exploitation of the CMCC Patents in Memantine and/or any
other adamantan derivatives for the CMCC Indications developed by
NTI, including any Confidential Information heretofore or hereafter
provided by CMCC to NTI pertaining to the CMCC Indications. NTI
shall further provide Merz with periodic updates relating to any
further research and development and/or improvement regarding the
Products pursuant to Article 10 hereof. NTI hereby agrees that Merz
shall have the right of access to, review and use of any and all
Confidential Information of NTI relevant in the context of any
required regulatory product approval (e.g., NDAs) provided,
however, that NTI shall not be required to disclose any of its
financial data to Merz.
7.3 NTI shall, upon Merz’
request, provide Merz with reasonable assistance in connection with
any applications for any required regulatory approvals for the
Products in any country within the Territory.
Article 8—License Fees and
Profit Sharing
8.1 In consideration for the rights
licensed by CMCC to Merz under Article 4.1 of this Agreement Merz
shall pay to CMCC US $ [*] (US Dollars [*] ) as a
one-time lump-sum license fee. The payment shall be due within five
(5) business days of the signing of this Agreement by the last
party and shall be made via wire transfer to the bank account of
CMCC with [*] (ABA # [*] ), Account No. [*] ,
Account Name: [*] ; Contact: [*] (Tel. No. [*]
).
8.2 Merz shall also pay US
$2,100,000 (US Dollars Two Million One Hundred Thousand) to NTI for
the license granted to Merz relating to NTI’s Confidential
Information pursuant to Article 4.2 and the waiver of its licensee
rights under the Exclusive License Agreement, provided, however,
that any such payment shall be conditioned upon NTI delivering to
Merz a board resolution approving this Agreement. The payment shall
be due within five (5) business days of the execution of this
Agreement by the last party and shall be made via wire transfer to
the bank account of NTI with [*] (ABA # [*] ),
Account No. [*] .
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8.3 Merz acknowledges and agrees that the
payments payable to CMCC and NTI under Article 8.1 and 8.2
respectively are in addition to any share of Royalty Income payable
to CMCC and NTI by Merz hereunder.
8.4 In consideration for the rights
conveyed and the obligations undertaken hereunder by each one of
the parties, each party shall be entitled to a percentage share in
the Royalty Income derived from the marketing and licensing of
Products for the Indications governed by this Agreement as set
forth in Exhibit C attached hereto. Payment of the percentage share
of Royalty Income, if any, due to CMCC and NTI shall be paid by
Merz to CMCC and NTI respectively within thirty (30) days of
the end of each calendar quarter by wire transfer to the bank
accounts of CMCC and NTI respectively.
8.5 Merz shall pay to CMCC an amount
equal to [*] % and to NTI an amount equal to [*] %,
the aggregate of which shall not exceed [*] ( [*] )%,
of all down-payments, lump-sum payments and milestone payments,
other than Royalty Income, received by Merz pursuant to any
licensing, development and marketing agreement entered into with
any Marketing Partner for Products pursuant to this Agreement. The
amounts payable by Merz to CMCC and NTI under this Article 8.5
shall be paid within thirty (30) days after the end of the calendar
quarter in which such payments were received by Merz.
8.6 All amounts payable to CMCC and
NTI shall be paid in United States Dollars (US$) and shall be paid
to the accounts specified in Article 8.1 and 8.2 respectively. For
purposes of determining the amounts payable with respect to any
Royalty Income or any other amount payable by Merz to NTI and CMCC
under Article 8.5, which Merz has not received in United States
Dollars, the currency conversion shall be made by using the average
of the exchange rate between the United States Dollars and the
currency in which Royalty Income or other income under Article 8.5
was received by Merz prevailing at Deutsche Bank during the last
calendar quarter prior to the due date of the payment.
8.7 In the event that any amount
payable to CMCC and/or NTI hereunder is not paid on the due date as
provided herein, such overdue amount shall bear interest at the
rate of [*] ( [*] )% per year or the maximum amount
permitted by law, whichever is less, until such time such overdue
amount has been paid.
8.8 Merz shall furnish CMCC and NTI
with a report on a quarterly basis, including the information
listed in Exhibit D hereof. Each report shall be submitted to CMCC
and NTI along with the amounts payable, if any, to CMCC and NTI
respectively under Article 8.4. Merz shall keep full, true and
accurate books of account in accordance with generally accepted
accounting principles to enable CMCC and NTI to ascertain the
payments made by Merz to NTI and CMCC under this Agreement. Said
books of account shall be kept at
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Merz’ principal place of business for a
period of at least five (5) years following the end of the
calendar year to which they pertain. CMCC and NTI shall have the
right, at their own expense, to audit such books of account to the
extent they pertain to payments made pursuant to this Agreement and
to the extent necessary to verify the reports provided by Merz to
CMCC and NTI hereunder.
Article 9—Supply of
Compound, Bulk Memantine and Finished Products
9.1 In the event that Merz supplies
and sells the Compound, directly or indirectly, to one or more
Marketing Partners for use in the manufacturing of any of the
Products for any or all Indications governed by this Agreement, the
parties hereby expressly acknowledge and agree that any and all
revenues derived by Merz from the sale of such Compound shall be
solely for the benefit of Merz, and Merz shall not be obligated to
share any such revenues with any of the other parties to this
Agreement; provided, however, that, subject to the provisions of
Article 5.2 hereof, if the price for the Compound specified in
Merz’ supply agreement with such Marketing Partner exceeds
[*] existing at the time of the execution of this Agreement,
Merz shall pay to CMCC and NTI their respective share of the excess
revenue as defined hereafter in accordance with the allocation of
Royalty Income as set forth in Article 8.4 and Exhibit C of this
Agreement. For purposes of this Article “excess
revenues” shall mean the difference between [*] . Merz
shall (i) furnish CMCC and NTI with a certificate executed by
an independent certified public accountant as to the [*] and
(ii) provide NTI and CMCC with reports of such sales of the
Compound in accordance with the provisions of Exhibit D
hereof.
9.2 Subject to Article 5.2 hereof,
in the event that Merz directly or indirectly supplies and sells
bulk Memantine products or finished Products to one or more
Marketing Partners or any other third party for any or all
Indications governed by this Agreement, the parties shall in good
faith negotiate an allocation among Merz, NTI and CMCC of a
percentage share of the sales price for such bulk Memantine
products or finished Memantine products; provided, however, that
the allocation of revenue set forth in Article 9.1 above regarding
the sale and supply of Compound to Marketing Partners shall be
taken into consideration. Merz shall provide NTI and CMCC with
reports of all such sales of bulk Memantine products and/or
finished Products in accordance with the provisions of Exhibit D
hereof. If the parties fail to reach an agreement on the
appropriate allocation of such revenues within a period of sixty
(60) days after the date on which such negotiations commenced,
any party shall be entitled to institute arbitration proceedings in
accordance with Article 18 hereof solely for the purpose of
determining the respective percentage share of the sales price of
each of the parties.
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Article 10—Further Development and
Research
10.1 NTI shall, at its own risk and
expense, initiate Phase IIb clinical studies for neuropathic pain.
The Phase IIb clinical studies for neuropathic pain shall be
initiated by December 31, 1998. NTI shall use commercially
reasonable efforts to complete such studies for neuropathic pain
within approximately fifteen (15) months after the
commencement of the studies; provided, however, that any
improvement of any Product developed as a result of such Phase IIb
clinical studies for neuropathic pain pursuant to this Article 10.1
shall also be governed by the rights and obligations set forth in
this Agreement. In addition, NTI shall at is own risk and expense,
initiate and conduct the clinical studies for AIDS related dementia
in accordance with the requirements of the AIDS Clinical Trial
Group (“ACTG”); provided, however, that any improvement
of any Product developed as a result of such clinical studies for
AIDS related dementia pursuant to this Article 10.1 shall also be
governed by the rights and obligations set forth in this Agreement.
NTI shall inform Merz and CMCC on a regular basis about all such
research and development work, including, but not limited to, Phase
IIb clinical studies and ACTG studies, and Merz reserves the right
to supervise any such further research and development as Merz
reasonably deems necessary. Any submission that NTI proposes to
make to the Food and Drug Administration with respect to all such
research and development work, including, but not limited to, Phase
IIb clinical studies and/or the ACTG studies shall be subject to
the prior review, comment and approval by Merz. Merz hereby grants
to NTI a limited, non-exclusive license to use the Merz Patents,
and a limited, non-exclusive sublicense to use the CMCC Patents and
any related CMCC Confidential Information licensed to Merz
hereunder, if any for the sole and exclusive purpose of conducting
such Phase IIb clinical studies and ACTG studies.
10.2 If NTI fails to initiate and
conduct either the Phase IIb clinical studies for neuropathic pain
and/or AIDS related dementia in accordance with the ACTG studies
therefor, CMCC and Merz shall each have the right to terminate this
Agreement with respect to NTI with immediate effect in accordance
with Articles 17.2 and 17.6 hereof. Upon termination in accordance
with this Article 10.2, NTI shall have no further rights under this
Agreement; provided, however that Merz’ obligation to
negotiate in good faith an allocation to NTI of a percentage share
of any revenue derived by Merz from the commercialization and
marketing of any Products or any derivatives thereof for any new
Indication under, and limited to the circumstances set forth in
Article 10.11 hereof, shall survive the termination of the
Agreement. The relationship between Merz and CMCC shall remain
unaffected by such termination, and the terms of this Agreement, to
the extent they apply to CMCC and Merz, shall continue to govern
the relationship between Merz and CMCC. Merz shall be entitled to
retain NTI’s percentage share of the Royalty Income and any
share of income under Article 8.5.
12
10.3 In the event that (i) NTI does not
initiate or conduct Phase IIb clinical studies for neuropathic pain
and AIDS related dementia as set forth in Article 10.1 above; or
(ii) NTI completes the Phase IIb clinical studies for
neuropathic pain and AIDS related dementia in accordance with the
ACTG studies therefor, and the results of such studies warrant
further research and development work, including but not limited to
Phase III clinical studies for the Indication neuropathic pain, as
determined by Merz, Merz shall use its commercially reasonable
efforts to cause a Marketing Partner to conduct further research
and development of Memantine for the CMCC Indications. If the first
Marketing Partner, who is willing to develop the Merz Indication,
is not willing to conduct such further research and development of
Memantine for the CMCC Indications, Merz shall use its commercially
reasonable efforts to identify a second Marketing Partner for the
further research and development of the CMCC Indications within
[*] after concluding an agreement with the first Marketing
Partner, and reach an agreement with such Marketing Partner as soon
as practicable thereafter.
10.4 If Merz is unable to reach an
agreement with any Marketing Partner within [*] ( [*]
) months for the CMCC Indications as set forth in Article 10.3
hereof, CMCC shall have the right to seek a Marketing Partner for
the CMCC Indications within [*] ( [*] ) months. Merz
will then use commercially reasonable efforts to enter into a
sublicense with the Marketing Partner identified by
CMCC.
10.5 If neither Merz nor CMCC is
able to identify a Marketing Partner for the CMCC Indications as
set forth in Articles 10.3 and 10.4 hereof, the Agreement may be
terminated in accordance with Article 17 hereof by mutual agreement
of CMCC and Merz. If this Agreement is terminated by mutual
agreement of Merz and CMCC, Merz shall have no further rights in
the CMCC Patents, and neither Merz nor NTI shall have any further
obligations with respect to the CMCC Patents and/or the CMCC
Indications. CMCC shall be free to conduct further research and
development with respect to the CMCC Patents and the CMCC
Indications. Upon termination of the Agreement in accordance with
this Article 10.5, Merz shall have no further payment obligations
of any Royalty Income, down-payments, milestone payments or lump
sum payments to CMCC and/or NTI as set forth in Article 8 hereof,
provided, however, that (i) nothing in this Article or in this
Agreement shall be construed as to release any of the parties to
this Agreement from any obligation, including payment obligations,
that matured prior to the effective date of such termination, and
(ii) Merz’ obligation to negotiate in good f