Exhibit 10.12
***Text Omitted and
Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 230.406
Development and
Commercialization License and Clinical Supply Agreement
by and between
NEUROBIOTEC
GmbH
and
PRESTWICK
Pharmaceuticals, Inc.
11
September 2003
This Development and
Commercialization License and Clinical Supply Agreement , dated
as of 11 September, 2003, by and between NeuroBiotec GmbH ,
Berlin/Germany, a company formed under the laws of Germany (“
NEUROBIOTEC ”), and Prestwick Pharmaceuticals,
Inc. , Washington D.C./USA, a company formed under the laws of
Delaware (“ PRESTWICK ”).
PREAMBLE
WHEREAS , prior to
2002 Schering (defined below) commenced, but did not complete, a
program to develop a Transdermal Formulation (defined herein) of
one of the Subject Compounds (defined herein) as a pharmaceutical
product for humans, and in the course of undertaking this program,
Schering created or otherwise obtained the Transferred Schering
Technology (defined herein);
WHEREAS ,
NEUROBIOTEC has acquired the Transferred Schering Technology
through assignment from Schering as set forth in that certain
Technology Transfer Agreement (defined herein as the “
TTA ”), and NEUROBIOTEC is using the Transferred
Schering Technology inter alia to develop Subject
Formulations (defined herein) of the Subject Compounds (defined
herein) as one or more Subject Products (defined herein) and to
seek regulatory approval for such Subject Products;
WHEREAS , pursuant
to the TTA, Schering has certain options (defined herein as the
“ Schering License Options ”) to license from
NEUROBIOTEC the Transferred Schering Technology and the NeuroBiotec
Licensed Technology (defined herein) in certain countries not
included in the Prestwick License Region (defined herein);
WHEREAS , the
Schering Existing Data (defined herein) include preclinical and
clinical safety and efficacy data obtained with oral and parenteral
formulations of one of the Subject Compounds, and whereas Phase 2b
trials sponsored by NEUROBIOTEC and designed to test the efficacy
and safety of a Transdermal Formulation of the Subject Compound as
a Subject Product are currently being conducted in the European
Union;
WHEREAS , the
parties believe that the Schering Existing Data and the data
additionally generated and comprising the NeuroBiotec Existing Data
indicate that [...***...] may be [...***...] such
that experience with [...***...] of one of the
[...***...] in a [...***...] the European Union may
[...***...] in the European Union;
WHEREAS , PRESTWICK
[...***...] has determined that it is in PRESTWICK’s
best interest to be granted by NEUROBIOTEC and whereas NEUROBIOTEC
has determined that it is in its best interest to grant to
PRESTWICK a license under the Subject Intellectual Property
(defined herein), which license shall be subject to the terms and
conditions set forth herein, and to engage with PRESTWICK in a
Cooperative Arrangement (defined herein) pursuant to which
PRESTWICK will undertake the Development Program (defined
herein);
WHEREAS ,
NEUROBIOTEC has made available to PRESTWICK copies of the TTA, the
Third Party Bulk Drug Substance Agreement (defined herein) and the
Third Party Formulation Agreement (defined herein) and whereas the
parties do not intend for any of the terms and conditions of this
Agreement to constitute a breach by either party of its obligations
under or otherwise conflict with any of the TTA, the Third Party
Bulk Drug Substance Agreement and/or the Third Party Formulation
Agreement;
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1.
WHEREAS , the TTA
specifically contemplates and approves of NEUROBIOTEC’s
license of the Transferred Schering Technology to PRESTWICK as
contemplated by this Agreement and provides for the payment by
PRESTWICK to Schering of royalties based on sales of Subject
Products in the Prestwick Licensed Region;
WHEREAS , under the
Cooperative Arrangement each of NEUROBIOTEC and PRESTWICK will to
the extent provided herein and permitted under the TTA support each
other in their respective activities contemplated hereby and will
consider the other as a favoured collaborator in connection with
each party’s development of the Subject Compounds in the
territory in which that party has the right to sell and have sold
Subject Products and, subject to the consent of the other party, in
the territory in which the other party has the right to sell and
have sold Subject Products;
WHEREAS ,
NEUROBIOTEC as set forth in and to the extent provided for in the
TTA has the right to be provided by Schering with the benefit of an
agreement between Schering and a third party for the manufacture of
bulk quantities of the Subject Compounds (the “ Bulk Drug
Substance Manufacturer ”) which allows NEUROBIOTEC access
to such bulk quantities, and in addition, NEUROBIOTEC relies on
another third party for the manufacture of non-commercial
quantities of Transdermal Formulations of the Subject Compounds
(the “ Formulation Manufacturer ”; together with
the Bulk Drug Substance Manufacturer, the “ Third Party
Manufacturers ”) and as set forth herein and as permitted
under the TTA, NeuroBiotec will provide supplies of Subject
Compounds, Subject Formulations and Subject Products to Prestwick
for purposes of conducting the Clinical Trials (defined herein)
comprising the Development Program;
NOW, THEREFORE , the
parties agree as follows:
1.
Definitions
The following terms, when
used in this Agreement, shall have the following meanings:
“ Adverse Drug
Experience ” shall have the meaning ascribed to that term
by the FDA in Title 21 of the U.S. Code of Federal Regulations,
Section 310.305(b) as set forth in Appendix 1.0 attached
hereto.
” Affiliate
” shall mean, with respect to a party, any person,
corporation, firm, joint venture or other entity which, directly or
indirectly, through one or more intermediates, controls, is
controlled by or is under common control with such party. As used
in this definition, “control” means possession of the
power to direct or cause the direction of the management and
policies of an entity, whether through the ownership of the
outstanding voting securities or by contract or otherwise.
” Agreement
” shall mean this agreement between NEUROBIOTEC and
PRESTWICK.
” Applicable
Development Cost ” shall have the meaning given to that
term in Section 2.3(b).
” Applicable
Formulation ” shall have the meaning given to that term
in Section 2.3(b)(i).
“ Approval
” shall mean the approval of an NDA in respect of a Subject
Product by the FDA or by any equivalent regulatory body in another
country.
“ Approvable
Letter ” shall mean with respect to a Subject Product a
decision by the EU Commission, a mutual recognition agreement in
the European Union, or a letter from the FDA, which such decision,
mutual recognition agreement or letter shall be, state or provide
that the Subject Product is approvable.
“ Base Rate
” shall have the meaning given to that term in
Section 4.2(a) hereof.
2.
“ Clinical
Data ” shall mean data collected by or for a party during
the course of a Clinical Trial with respect to a Subject Project
where such data has been audited and reviewed by or for such party
in accordance with the requirements applicable to the submission of
such data to the FDA, EMEA or comparable regulatory authority in
connection with seeking an Approval for such Subject Product from
that authority.
“ Clinical
Development ” shall mean with respect to a subject
Product the conduct of Clinical Trials in respect thereof and the
related regulatory compliance activities required to obtain
Approval thereof.
“ Clinical
Trials ” shall mean with respect to a Subject Product any
one or more Phase 1 Clinical Trials, Phase 2 Clinical Trials, Phase
2a Clinical Trials, Phase 2b Clinical Trials, Phase 3 Clinical
Trials, or Phase 4 Clinical Trials.
“ Compassionate
Use ” shall mean the treatment of human patients by
doctors on a named patients basis with a pharmaceutical that is not
the subject of an Approval.
“ Cooperative
Arrangement ” shall have the meaning given to that term
in Section 3.2 hereof.
“ Development
Cost ” shall mean all net amounts paid or incurred by
PRESTWICK directly attributable to the carrying out of a specific
preclinical study or clinical trial in the course of the
Development Program determined in a reasonable manner
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(i) |
by contracting with third parties (including, without
limitation, hospitals, medical centers, physicians, patients,
suppliers, laboratories and contract services organizations) for
services that are supported by invoices describing the work
performed; |
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(ii) |
as labor costs (salaries, wages and employee benefits, but
excluding any employee benefits associated with equity incentive
plans and with similar compensation); |
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(iii) |
as costs for materials and supplies; |
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(iv) |
as costs for insurance, telephone expenses, training, travel
and accommodation; and |
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(v) |
as allocated maintenance and depreciation costs for buildings
directly dedicated to the development of such Subject Product but
excluding costs and charges relating to unused capacity,
development of other products, and amortization of property, plant
and equipment not directly related to development of such Subject
Product in accordance with the Development Program; all of the
amounts per this clause (v) not to exceed [...***...]
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it being understood
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(i) |
that Development Costs shall under no circumstances include any
amounts funded by any grant, contract, or otherwise by another
person or any governmental entity and |
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(ii) |
that the aggregate off all costs per clauses (i) through
(v) above shall be reduced by the value of any realized tax
credit or equivalent benefit applicable to such specific
preclinical study or clinical trial. |
“ Development
Program ” shall mean the program carried out in the
Prestwick License Region, and to the extent permitted under
Section 2.l(b) hereof, outside the Prestwick License Region,
of Clinical
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3.
Development and application
for Approval from the FDA and the equivalent Canadian
pharmaceutical regulatory body described in Appendix 1.1
hereto the objective of which is to obtain Approval from the FDA
and the equivalent Canadian pharmaceutical regulatory body to
market one or more Subject Products for the Initial Transdermal
Indication and the Initial IV and SC Indication in the United
States and Canada, respectively.
“ Effective
Date ” shall mean the date of this Agreement as set forth
in the first paragraph hereof.
“ EMEA ”
shall mean the European Medicine Evaluation Agency or any successor
entity thereto.
“ Exclusivity
” shall have the meaning given to that term in
Section 4.2(a) hereof.
“ Existing
Data ” shall mean the Schering Existing Data and the
Neurobiotec Existing Data.
“ FDA ”
shall mean the United States Food and Drug Administration of the
United States Department of Health and Human Services, or any
successor agency with responsibility for regulating the
development, manufacture and sale of human pharmaceutical
products.
“ First Commercial
Sale ” shall mean with respect to a Subject Product and a
given country the date on which that Subject Product is first sold
commercially by a party or on a party’s behalf in that
country pursuant to any requisite Approval, provided that where
such a first commercial sale has occurred in a country for which
pricing or reimbursement approval is necessary for sale, then such
sale shall not be deemed First Commercial Sale until such pricing
or reimbursement approval has been obtained.
“ GMP ”
shall mean the Good Manufacturing Practices for the manufacture of
drugs promulgated by the FDA and set forth in Title 21 of the U.S.
Code of Federal Regulations, Parts 210 and 211 as set forth in
Appendix 1.0 attached hereto and as may be amended from time
to time.
“ Hatch-Waxman
Act ” shall mean The Drug Price Competition and Patent
Term Restoration Act of 1984, as amended, originally enacted as
United States Pub. L. No. 98-417, 98 Stat. 1585 (1984) as
attached hereto as Appendix 1.0 attached hereto and as may be
amended from time to time.
“ Initial
Indications ” shall mean the Initial Transdermal
Indication and the Initial IV and SC Indication.
“ Initial IV and
SC Indication ” shall mean [...***...]
Parkinson’s Disease following [...***...] and
[...***...] for [...***...] .
“ Initial
Transdermal Indication ” shall mean Parkinson’s
Disease.
“ IND ”
shall mean an application for an Investigational New Drug exemption
required to be filed with and accepted by the FDA prior to the
conduct in the United States of any Clinical Trials of such drug,
or any equivalent such application in countries other than the
United States.
“ IV and SC
Formulation ” shall mean a formulation of a
pharmaceutical product engineered to be administered to a subject
patient through intravenous or subcutaneous means.
“ Life-Threatening
Adverse Drug Experience ” shall have the meaning ascribed
to that term by the FDA in Title 21 of the U.S. Code of Federal
Regulations, Section 310.305(b) as set forth in Appendix 1.0
attached hereto.
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4.
“ Marketing
Objectives ” shall mean the marketing objectives defined
in Section 3.5 hereof.
“ NDA ”
shall mean a new drug application required to be filed with and
approved by the FDA prior to the marketing and sale of a drug in
the United States or any equivalent thereof in countries other than
the United States.
“ Net Sales
” shall mean the gross amount invoiced for sales of a Subject
Product by PRESTWICK or any Affiliate or sublicensee of PRESTWICK
to third parties, less usual and customary deductions for returns
(including withdrawals and recalls), rebates (price reductions,
including Medicaid and similar types of rebates (for example,
chargebacks), volume (quantity) and cash discounts granted at
the time of invoicing, sales taxes and other taxes directly linked
and included in the amount invoiced, and the like. Any deductions
listed above which involve a payment to the seller of the Subject
Project shall be taken as a deduction against aggregate sales for
the period in which the payment is made. Sales of Subject Products
between a party and its Affiliate solely for research or clinical
testing purposes shall be excluded from the computation. In the
event a Subject Product is sold in the form of a combination
product containing one or more active ingredients in addition to a
Subject Product, Net Sales for such combination product will be
adjusted by multiplying actual Net Sales of such combination
product by the fraction A/(A+B) where A is the invoice price of the
Subject Product, if sold separately, and B is the invoice price of
any other active ingredient or ingredients in the combination, if
sold separately. If, on a country-by-country basis, the other
active ingredient or ingredients in the combination are not sold
separately in that country, Net Sales shall be calculated by
multiplying actual Net Sales of such combination product by the
fraction A / C where A is the invoice price of the Subject Product
if sold separately, and C is the invoice price of combination
product. If, on a country-by-country basis, neither the Subject
Product nor the other active component or components of the
combination product is sold separately in said country, Net Sales
shall be determined between the parties in good faith.
“ NeuroBiotec
Additional Data ” shall mean Chemistry and Manufacturing
Controls, absorption, distribution, metabolism and excretion,
toxicology, pharmacokinetic, pharmacodynamic and Clinical Data
relating to the Subject Compounds, Subject Formulations and Subject
Products generated by or otherwise obtained by NEUROBIOTEC
following the Effective Date, but not including NeuroBiotec Future
Improvements.
“ NeuroBiotec
Existing Data ” shall mean Chemistry and Manufacturing
Controls, absorption, distribution, metabolism and excretion,
toxicology, pharmacokinetic, pharmacodynamic and Clinical Data
relating to the Subject Compounds, Subject Formulations and Subject
Products generated by or otherwise obtained by NEUROBIOTEC by the
Effective Date other than the Schering Existing Data and described.
in Appendix 1.2 hereto.
“ NeuroBiotec
Existing Improvements ” shall mean those certain
galenical improvements of the Subject Formulations existing as of
the Effective Date and described in Appendix 1.3 hereto.
“ NeuroBiotec
Future Improvements ” shall mean galenical improvements
of the Subject Formulations conceived, created, developed and/or
otherwise obtained by NEUROBIOTEC following the Effective Date.
“ NeuroBiotec
Licensed Technology ” shall mean the NeuroBiotec Patents,
the NeuroBiotec Existing Data, the NeuroBiotec Additional Data, and
the NeuroBiotec Existing Improvements.
“ NeuroBiotec
Patents ” shall mean the patent applications and issued
patents as listed in Appendix 1.4 hereto and any and all foreign
counterparts thereof including any patents issued on such
applications and any and all divisionals, continuations,
continuations-in-part, reissues, reexaminations, extensions,
confirmations, registrations, and revalidations of any such patent
or patent application.
5.
“ NeuroBiotec
Technology ” shall mean the NeuroBiotec Licensed
Technology and the NeuroBiotec Future Improvements.
“ [...***...]
Development Agreement ” shall mean that certain
Development Agreement, dated 22 June 2000 by and between
[...***...] and [...***...] , a company organized
under the laws of Germany, as assigned to NEUROBIOTEC in the TTA
and relating to the development of Transdermal Formulations of the
Subject Compounds.
“ Other
Non-peroral Sustained Release Formulations ” shall mean a
formulation of a pharmaceutical product engineered to administer
such pharmaceutical product to a subject patient in a manner
different from Transdermal Formulations, IV & SC Formulations
and formulations for oral administration.
“ Phase 1 Clinical
Trial ” shall have the meaning described in the ICH
Harmonized Tripartite Guideline entitled “General
Considerations for Clinical Trials” as amended, but shall be
limited to such studies as are described in the Development Program
and such other studies as the FDA, EMEA or other regulatory
authority may require prior to the initiation of Phase 2 Clinical
Trials.
“ Phase 2 Clinical
Trial ” shall have the meaning described in the ICH
Harmonized Tripartite Guideline entitled “General
Considerations for Clinical Trials” as amended, but shall be
limited to such studies as are described in the Development
Program.
“ Phase 2a
Clinical Trial ” shall mean any Phase 2 Clinical Trial
designed as a short-term, proof of concept study in an appropriate
number of patients to demonstrate the therapeutic efficacy of a
drug for a particular therapeutic indication.
“ Phase 2b
Clinical Trial ” shall mean any Phase 2 Clinical Trial
designed to evaluate the therapeutic efficacy and safety of a drug
for a particular therapeutic indication.
“ Phase 3 Clinical
Trial ” shall have the meaning described in the ICH
Harmonized Tripartite Guideline entitled “General
Considerations for Clinical Trials” as amended.
“ Phase 4 Clinical
Trial ” shall have the meaning described in the ICH
Harmonized Tripartite Guideline entitled “General
Considerations for Clinical Trials” as amended, where such
clinical trial is required by the FDA or any equivalent regulatory
body in another country as a condition to the receipt or
maintenance of an Approval.
“ Prestwick
Existing and Additional Data ” shall mean Chemistry and
Manufacturing Controls, absorption, distribution, metabolism and
excretion, toxicology, pharmacokinetic, and pharmacodynamic data
relating to the Subject Compounds, Subject formulations and Subject
Products generated by or otherwise obtained by Prestwick prior to,
on the or following the Effective Date, but not including Prestwick
Future Improvements.
“ Prestwick
Clinical Data ” shall mean Clinical Data relating to the
Subject Compounds, Subject Formulations and Subject Products
arising out of the Development Program or otherwise generated or
obtained by PRESTWICK prior to or following the Effective Date.
“ Prestwick
Data ” shall mean Prestwick Existing and Additional Data
and Prestwick Clinical Data.
“ Prestwick Future
Improvements ” shall mean galenical improvements of the
Subject Formulations conceived, created, developed and/or otherwise
obtained by PRESTWICK following the Effective Date.
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6.
“ Prestwick
License Region ” shall mean the United States and
Canada.
“ Schering
” shall mean Schering Aktiengesellschaft, Berlin/Germany, a
company organized under the laws of Germany.
“ Schering
Existing Data ” shall mean any raw data reports,
specifications, testing standards, method descriptions, Chemical
Manufacturing Controls data, working reports and Know-how (as
defined in the TTA) relating to the Subject Compounds, Subject
Formulations and Subject Products transferred by Schering to
NEUROBIOTEC pursuant to the TTA and described in Appendix 1.5
hereto.
“ Schering License
Options ” shall mean the options granted by NEUROBIOTEC
to Schering under Sections 6 and 7 of the TTA pursuant to which
Schering has the right to obtain licenses under the Subject
Intellectual Property for commercial exploitation outside the
Prestwick License Region.
“ Schering
Patents ” shall mean the patent applications and issued
patents comprising the patent families 50481A, 51843A 51963A 52017A
as listed in Appendix 1.6 hereto and any and all foreign
counterparts thereof including any patents issued on such
applications and any and all divisionals, continuations,
continuations-in-part, reissues, reexaminations, extensions,
confirmations, registrations, and revalidations of any such patent
or patent application.
“ Serious Adverse
Drug Experience ” shall have the meaning ascribed to that
term by the FDA in Title 21 of the U.S. Code of Federal
Regulations, Section 310.305(b) as set forth in
Appendix 1.0 attached hereto.
“ Subject
Compounds ” shall mean the chemical compounds Lisuride
and Lisuride hydrogenmaleate (including all pharmaceutically active
salts and esters thereof).
“ Subject
Dossier ” shall have the meaning given to that term in
Section 2.3(b).
“ Subject
Formulations ” shall mean Transdermal Formulations, IV
and SC Formulations, and Other Non-peroral Sustained Release
Formulations of a specified pharmaceutical product.
“ Subject
Intellectual Property ” shall mean the Schering Patents,
the Schering Existing Data and the NeuroBiotec Licensed
Technology.
“ Subject
Patents ” shall mean the Schering Patents and the
NeuroBiotec Patents.
“ Subject
Product ” shall mean a pharmaceutical product for
administration to humans and formulated as a Subject Formulation of
a Subject Compound.
“ Subject
Report ” shall have the meaning given to that term in
Section 2.3(b).
“ Territory
” shall mean all countries of the world.
“ Third Party
Agreements ” shall mean the Third Party Bulk Drug
Substance Agreement and the Third Party Formulation Agreement.
“ Third Party Bulk
Drug Substance Agreement ” shall mean that certain supply
agreement, dated 05.03./15.03.2001, between Schering and
[...***...] a company organized under the laws of
[...***...] , and any successor thereto as the supplier
thereunder, and in accordance therewith [...***...]
coordinates
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7.
orders, sales and
logistics, which such agreement relates to the manufacture and
supply of bulk quantities of Subject Compounds, and attached hereto
as Appendix 1.7.
“ Third Party Bulk
Drug Substance Manufacturer ” shall mean the manufacturer
and supplier of bulk quantities of Subject Compounds under the
Third Party Bulk Drug Substance Agreement.
“ Third Party
Collaboration ” shall mean any joint venture,
collaboration, cooperative arrangement or the like by and among
NEUROBIOTEC and one or more third parties relating to the
development and commercialization of Subject Compounds, Subject
Formulations, Subject Products or the NEUROBIOTEC Technology.
“ Third Party
Collaboration Agreement ” shall mean any agreement,
contract or like instrument pursuant to which NEUROBIOTEC enters a
Third Party Collaboration.
“ Third Party
Formulation Agreement ” shall mean the [...***...]
Development Agreement, which such agreement relates to the
development, manufacture and supply of transdermal formulations of
Subject Compounds, attached hereto as Appendix 1.8.
“ Third Party
Formulation Manufacturer ” shall mean [...***...]
, a company organized under the laws of Germany, as the
manufacturer and supplier of quantities of formulated Subject
Compounds under the Third Party Formulation Agreement.
“ Third Party
Manufacturers ” shall mean the Third Party Bulk Drug
Substance Manufacturer and the Third Party Formulation
Manufacturer.
“ Transdermal
Formulation ” shall mean a formulation of a
pharmaceutical product engineered to transdermally administer such
pharmaceutical product to patients.
“ Transferred
Schering Technology ” shall mean the rights to the
Subject Patents and the Schering Existing Data transferred to
NEUROBIOTEC pursuant to the TTA.
“ TTA ”
shall mean that certain Technology Transfer Agreement, dated 30
May 2002, between NEUROBIOTEC and Schering, as amended by an
amendment, dated September 3, 2003, between NEUROBIOTEC and
Schering, and as further amended by an amendment, dated
September 11, 2003, by and among NEUROBIOTEC, Schering and
PRESTWICK, attached hereto as Appendix 1.9.
“ TTA Closing
Date ” shall mean 30 May 2002 determined in
accordance with Section 18.1 of the TTA.
2. License
Grants of Subject Intellectual Property and Prestwick
Data
2.1 License of Subject
Intellectual Property .
(a) NEUROBIOTEC hereby grants to PRESTWICK a royalty-bearing
license under the Subject Intellectual Property, with the right to
grant sublicenses, which shall be exclusive (even as to
NEUROBIOTEC), to sell or have sold and import or have imported in
the Prestwick License Region Subject Products for any and all
indications, subject to NEUROBIOTEC’s right to convert such
exclusive license into a non-exclusive license if PRESTWICK fails
to timely satisfy the applicable Marketing Objectives.
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(b) In addition, NEUROBIOTEC hereby grants to PRESTWICK a
non-exclusive license under the Subject Intellectual Property to
manufacture or have manufactured, use or have used, develop or have
developed outside the Prestwick License Region Subject Products for
any and all indications for the sole purpose of carrying out in
part the Development Program, provided that prior to carrying out
any such activity outside the Prestwick License Region, PRESTWICK
provides written notice thereof to NEUROBIOTEC and NEUROBIOTEC
thereupon consents thereto, which such consent shall not be
unreasonably withheld.
(c) In addition, NEUROBIOTEC hereby grants to PRESTWICK a
non-exclusive license under the Subject Intellectual Property to
manufacture or have manufactured and to use or have used inside or
outside the Prestwick License Region Subject Products for any and
all indications for the purpose of selling or having sold and.
importing or having imported such Subject Products in the Prestwick
License Region under the license granted in Section 2.1(a)
hereof.
2.2 License of Prestwick
Data .
(a) PRESTWICK hereby grants to NEUROBIOTEC a
[...***...] license under the Prestwick Data, with the right
to grant sublicenses, which shall be [...***...] , to sell
or have sold and import or have imported outside the Prestwick
License Region Subject Products for any and all indications,
subject to PRESTWICK’s right to [...***...] if
NEUROBIOTEC fails to timely satisfy the applicable Marketing
Objectives.
(b) In addition, PRESTWICK hereby grants to NEUROBIOTEC a
[...***...] , non-exclusive license under the Prestwick Data
to manufacture or have manufactured, use or have used, develop or
have developed inside the Prestwick License Region Subject Products
for any and all indications for the purpose of carrying out
Clinical Development of Subject Products, provided that prior to
carrying out any such activity inside the Prestwick License Region,
NEUROBIOTEC provides written notice thereof to PRESTWICK and
PRESTWICK thereupon consents thereto, which such consent shall not
be unreasonably withheld.
(c) In addition, PRESTWICK hereby grants to NEUROBIOTEC a
[...***...] , non-exclusive license under the Prestwick Data
to manufacture or have manufactured and to use or have used inside
or outside the Prestwick License Region Subject Products for any
and all indications for the purpose of selling or having sold and
importing or having imported such Subject Products outside the
Prestwick License Region under the license granted in
Section 2.2(a) hereof.
2.3 Consideration for
License of Prestwick Data .
(a) General Rule . Under the license granted by
PRESTWICK to NEUROBIOTEC under Section 2.2 hereof, PRESTWICK will
provide NEUROBIOTEC with access to and use of the Prestwick Data
without charge, subject to Sections 2.3(b) and 2.3(c)
below.
(b) Reimbursement of Development Costs . In the case
of any and all full study reports prepared by PRESTWICK that are
used in their entirety for more than informational purposes in
dossiers for registration of Subject Products submitted by
NEUROBIOTEC outside the PRESTWICK License Region (each such full
study report so used being a “ Subject Report ”;
each such dossier being a “ Subject Dossier ”),
NEUROBIOTEC shall reimburse PRESTWICK for the portion specified
below of PRESTWICK’s Development Cost attributable to each
such Subject Report (the “ Applicable Development Cost
”) in accordance with the following provisions, and such
provisions shall apply
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9.
separately to Subject
Reports for Subject Products that are Transdermal Formulations and
Subject Reports for Subject Products that are not Transdermal
Formulations.
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(i) |
Use of Subject Reports Prior to Expiration of Applicable
Schering License Option . If any Subject Report is so used
by NEUROBIOTEC for a Subject Product prior to the expiration of the
applicable Schering License Option relating to the class of
formulations containing such Subject Product (such class of
formulations being an “ Applicable Formulation
”), then |
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(A) |
in the case where Schering subsequently exercises the
applicable Schering License Option with respect to the Applicable
Formulation and at such time as and to the extent that
NEUROBIOTEC receives payments from Schering resulting from
Schering’s exercise of the option designated as “Step
II” under the TTA as payments towards NEUROBIOTEC’s
development costs (as defined in the TTA) incurred in connection
with a Subject Product where such costs are costs of PRESTWICK
reimbursed hereunder by NEUROBIOTEC to PRESTWICK, then NEUROBIOTEC
shall reimburse PRESTWICK for [...***...] the Applicable
Development Cost, and such reimbursement shall be paid within
thirty (30) days following such receipt of payments by
NEUROBIOTEC from Schering; provided, that the milestone payment to
be paid by PRESTWICK to NEUROBIOTEC under Section 4.l(a)(v)
hereof upon the [...***...] shall be [...***...] of
the amount of such reimbursement so paid to PRESTWICK under this
clause (A), subject to [...***...] in the amount of such
milestone payment after giving effect to any and all reimbursement
payments made to PRESTWICK under this clause (A); |
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(B) |
in the case where the applicable Schering License Option
with respect to the Applicable Formulation expires unexercised and
NEUROBIOTEC has not entered into a Third Party Collaboration
relating to the Subject Product that is the subject of such Subject
Report , then |
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(I) |
in respect of any first Subject Report in respect of a Clinical
Trial identified and used by NEUROBIOTEC, the percentage of the
Applicable Development Cost shall be [...***...] , and |
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(II) |
in respect of additional such Subject Reports, the percentage
of the Applicable Development Cost shall be [...***...]
where such reimbursement shall be paid in the following
manner: |
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(1) |
[...***...] of such reimbursement shall be in the form
[...***...] ; and |
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(2) |
[...***...] of such reimbursement shall be in the form
of [...***...] ; provided, however , that if
subsequent to the receipt of such regulatory approval, NEUROBIOTEC
seeks to enter into a Third Party Collaboration relating to such
Subject Product, then PRESTWICK and NEUROBIOTEC shall engage in
commercially reasonable efforts to negotiate and agree upon in good
faith an acceleration of PRESTWICK’s receipt of any
reimbursement amount then remaining unpaid under this clause
(2) prior to or simultaneously with NEUROBIOTEC’s
execution of the Third Party Collaboration Agreement; further
provided, however , that if PRESTWICK and NEUROBIOTEC are
unable to so negotiate and agree upon such |
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Confidential Treatment Requested |
10.
acceleration of PRESTWICK’s receipt of such reimbursement
prior to or simultaneously with NEUROBIOTEC’s execution of
such Third Party Collaboration Agreement, then PRESTWCK and
NEUROBIOTEC shall do so as promptly as possible thereafter; and
further provided, however , that the amount of any such
[...***...] .
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(C) |
in the case where the applicable Schering License Option
with respect to the Applicable Formulation expires unexercised and
NEUROBIOTEC seeks to enter a Third Party Collaboration relating to
the Subject Product prior to the receipt by NEUROBIOTEC of
regulatory approval to market such Subject Product , then the
percentage of the Applicable Development Cost to be reimbursed by
NEUROBIOTEC to PRESTWICK and the terms of payment of such
reimbursement shall be negotiated and agreed in good faith by
NEUROBIOTEC and PRESTWICK, each expending commercially reasonable
efforts to do so, prior to or simultaneously with
NEUROBIOTEC’s execution of the applicable Third Party
Collaboration Agreement; provided, however , that if
PRESTWICK and NEUROBIOTEC are unable to so negotiate and agree upon
such acceleration of PRESTWICK’s receipt of such
reimbursement prior to or simultaneously with NEUROBIOTEC’s
execution of such Third Party Collaboration Agreement, then
PRESTWICK and NEUROBIOTEC shall do so as promptly as possible
thereafter. |
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(ii) |
Use of Subject Reports After Expiration of Applicable
Schering License Option . If any Subject Report is so used
by NEUROBIOTEC for a Subject Product after expiration of the
applicable Schering License Option with respect to the Applicable
Formulation, then |
| |
(A) |
in the case where NEUROBIOTEC has not entered into a Third
Party Collaboration relating to the Subject Product , then |
| |
(I) |
in respect of any first Subject Report in respect of a Clinical
Trial identified and used by NEUROBIOTEC, the percentage of the
Applicable Development Cost shall be [...***...], provided
that this clause (I) shall apply only if NEUROBIOTEC has not
previously submitted a Subject Report entitled to the benefit of
Section 2.3(b)(i)(B)(I), and |
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(II) |
in respect of additional such Subject Reports, the percentage
of the Applicable Development Cost shall be [...***...]
where such reimbursement shall be paid in the following
manner: |
| |
(1) |
[...***...] of such reimbursement shall be in the form
of [...***...] ; and |
| |
| |
(2) |
[...***...] of such reimbursement shall be in the form
of [...***...] ; provided, however , that if
subsequent to the receipt of such regulatory approval, NEUROBIOTEC
seeks to enter into a Third Party Collaboration relating to such
Subject Product, then PRESTWICK and NEUROBIOTEC shall each use
commercially reasonable efforts to negotiate and agree upon in good
faith an acceleration of PRESTWICK’s receipt of any
reimbursement amount then remaining unpaid under this clause
(2) prior to or simultaneously with NEUROBIOTEC’s
execution of the Third Party Collaboration Agreement; provided,
however , that if PRESTWICK and |
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Confidential Treatment Requested |
11.
NEUROBIOTEC are unable to so negotiate and agree upon such
acceleration of PRESTWICK’s receipt of such reimbursement
prior to or simultaneously with NEUROBIOTEC’s execution of
such Third Party Collaboration Agreement, then PRESTWICK and
NEUROBIOTEC shall do so as promptly as possible thereafter; and
further provided, however , that the amount of any such
[...***...] .
| |
(B) |
in the case where NEUROBIOTEC seeks to enter into a Third
Party Collaboration prior to such use of such Subject Report ,
then the percentage of the Applicable Development Cost to be
reimbursed by NEUROBIOTEC to PRESTWICK and the terms of payment of
such reimbursement shall be negotiated in good faith by NEUROBIOTEC
and PRESTWICK, each expending commercially reasonable efforts to do
so, prior to or simultaneously with NEUROBIOTEC’s execution
of the applicable Third Party Collaboration Agreement; provided,
however , that if PRESTWICK and NEUROBIOTEC are unable to so
negotiate and agree upon such acceleration of PRESTWICK’s
receipt of such reimbursement prior to or simultaneously with
NEUROBIOTEC’s execution of such Third Party Collaboration
Agreement, then PRESTWICK and NEUROBIOTEC shall do so as promptly
as possible thereafter. |
2.4
Non-Transferability . Notwithstanding any assignment of
NEUROBIOTEC’s or PRESTWICK’s rights otherwise permitted
under this Agreement, the rights in the case of an assignment by
PRESTWICK under Section 2.1 hereof and in the case of an
assignment by NEUROBIOTEC under Section 2.2 hereof shall not
be transferable without the express consent of respective other
party, which consent may be withheld in such other party’s
sole discretion.
2.5 Sublicenses . Any
sublicense (each a “ Sublicense ”) to any third
party granted pursuant to the license granted in Section 2.1
shall contain terms and conditions substantially identical to those
contained in this Agreement in respect of such license.
2.6 License of Future
Improvements . From time to time during the term of this
Agreement, each of NEUROBIOTEC and PRESTWICK will upon request from
the other party engage in good faith negotiations to grant to the
other party a license to the NeuroBiotec Future Improvements and
the Prestwick Future Improvements, respectively, for exploitation
in the territory in which such other party has the right to sell
and have sold Subject Products.
2.7 Disclosure . As
promptly as possible, but not later than three (3) months,
after the Effective Date, NEUROBIOTEC shall complete the disclosure
to PRESTWICK of the Subject Intellectual Property, the NeuroBiotec
Existing Data, and the NeuroBiotec Existing Improvements, and as
promptly as possible, but not later than three (3) months,
after the Effective Date, PRESTWICK shall complete the disclosure
to NEUROBIOTEC of the Prestwick Data available to Prestwick at the
Effective Date. From time to time during the Agreement, each of
NEUROBIOTEC and PRESTWICK shall provide to the other party such
information about the NeuroBiotec Additional Data and the Prestwick
Data, respectively; as such information becomes available in order
for such other party to exploit such data under the license rights
granted under Sections 2.1 and 2.2, respectively.
2.8 Schering License
Options . NEUROBIOTEC shall notify PRESTWICK promptly upon the
exercise by Schering of any Schering License Option and the failure
by Schering to exercise any Schering License Option by the exercise
date thereof.
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Confidential Treatment Requested |
12.
3. Development
Program; Cooperative Arrangement
3.1 Development
Program . PRESTWICK hereby agrees to undertake and to complete
the Development Program in order to develop Subject Products for
commercialization in the Prestwick License Region, provided,
however, that Prestwick may abandon the Development Program or part
thereof with respect to a Subject Compound, Subject Formulation or
Subject Product after giving timely written notice thereof to
NEUROBIOTEC and after allowing NEUROBIOTEC adequate time to comment
on such plans to abandon the Development Program or such part
thereof, if PRESTWICK shows that
(a) it is [...***...] to successfully complete the
Development Program or such part thereof or
(b) the completion of the Development Program or such part
thereof would [...***...] to [...***...] ; it being
understood that the [...***...] of so completing the
Development Program or such part thereof shall only be
[...***...] if the [...***...] of completing the
Development Program or such part thereof (determined on the basis
of a [...***...] by the Development Program or such part
thereof and the [...***...] of this Agreement as a result of
the [...***...] of [...***...] or otherwise in
connection with this Agreement) is [...***...] under the
then relevant facts, circumstances and prospects for the
Development Program or such part thereof.
If and when PRESTWICK
abandons the Development Program or such part thereof or so informs
NEUROBIOTEC, all licenses granted to PRESTWICK relating to the
Development Program or such part thereof under this Agreement
terminate. For the removal of doubt, under this Section 3.1,
the Development Program and licenses granted to PRESTWICK relating
thereto may be abandoned with respect to a specific Subject
Compound, Subject Formulation or Subject Product but continued with
respect to other Subject Compounds, Subject Formulations and
Subject Products.
In addition, PRESTWICK
agrees to bear the expense of any additional pre-clinical studies
(including the expense of Subject Compounds provided by NEUROBIOTEC
and required for such studies) that the FDA or the equivalent
Canadian pharmaceutical regulatory body, as applicable, requires
for PRESTWICK to conduct clinical trials and/or to obtain the
Approval in the United States or Canada, as applicable, of a
Subject Product comprising a Transdermal Formulation of a Subject
Compound for the Initial Transdermal Indication.
3.2 Cooperative
Arrangement . NEUROBIOTEC and PRESTWICK will collaborate with
each other in a mutually complementary manner for the purpose of
further developing the Subject Products, the Subject Intellectual
Property, and the Improvements (such collaboration being the
“ Cooperative Arrangement ”). In furtherance of
the Cooperative Arrangement,
(a) NEUROBIOTEC and PRESTWICK will initially seek to develop
and commercialize in their respective territories Subject Products
for the Initial Indications.
(b) PRESTWICK shall be responsible for the development of
Subject Products for the Initial Indicati
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