Document:

exv10w12

 

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

	 	(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;
	 
	 	(ii)  	as labor costs (salaries, wages and employee benefits, but excluding any
employee benefits associated with equity incentive plans and with similar
compensation);
	 
	 	(iii)  	as costs for materials and supplies;
	 
	 	(iv)  	as costs for insurance, telephone expenses, training, travel and accommodation;
and
	 
	 	(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 [...***...] ;

it being understood

	 	(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
	 
	 	(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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“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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separately to Subject Reports for Subject Products that are Transdermal Formulations and
Subject Reports for Subject Products that are not Transdermal Formulations.

	 	(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

	 	(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);
	 
	 	(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

	 	(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
	 
	 	(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 [...***...]; 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 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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 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 [...***...].

	 	(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.

	 	(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
	 
	 	(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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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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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
Indications in the Prestwick License Region in accordance with the Development Program

          (c) In accordance with the disclosure requirements of Section 2.6,

	 	(i)  	NEUROBIOTEC will deliver and make available to PRESTWICK (A) any and
all Existing Data available to NEUROBIOTEC at the Effective Date required for the
preparation by PRESTWICK of an IND and NDA for any Subject Product as promptly as

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possible, but not later than three (3) months, after the Effective Date and (B) any
NeuroBiotec Additional Data promptly as such becomes available, and

	 	(ii)  	PRESTWICK shall deliver and make available to NEUROBIOTEC (A) any and
all Prestwick Data available to Prestwick at the Effective Date as promptly as
possible, but not later than three (3) months, after the Effective Date and (B) any
other Prestwick Data promptly as such other Prestwick Data become available.

For purposes of clauses (i) and (ii) of this subsection (c), the parties acknowledge
that the data to be transferred within the three months immediately following the
Effective Date are relevant to and/or necessary for the conduct of the Development
Program, including, without limitation, the preparation of one or more INDs and NDAs,
but do not comprise as of the Effective Date and are not expected to comprise during
such three month period all of the data required for the preparation of such INDs and
NDAs.”

          (d) except as otherwise provided in the reimbursement provisions set forth in Section 2.3
hereof, each party shall bear the expenses that it incurs in carrying out the Cooperative
Arrangement.

     3.3 Supply of Subject Products.

          (a) NEUROBIOTEC agrees to supply PRESTWICK with clinical supplies of Subject Products in bulk
formulated form for the Development Program, such supplies to be manufactured by the Third Party
Manufacturers and purchased by PRESTWICK from NEUROBIOTEC in accordance with the terms set forth in
Appendix 3.3 hereto and at [...***...] .

          (b) NEUROBIOTEC and PRESTWICK shall jointly coordinate the selection of contracting with
commercial manufacturers of the Subject Compounds and Subject Products. It is currently
contemplated that PRESTWICK will purchase such supplies from NEUROBIOTEC from the Third Party
Manufacturers; provided, however, that PRESTWICK acknowledges that NEUROBIOTEC shall not be
responsible for any commercial supplies of the Subject Products to PRESTWICK.

     3.4 Right of First Refusal: Non-Competition. Until [...***...], (i) NEUROBIOTEC will
promptly inform PRESTWICK of any compound or product in the nature of a doparmine agonist in any
type of formulation, including, without limitation, [...***...], that NEUROBIOTEC develops or obtains
or seeks to develop or obtain and shall promptly provide PRESTWICK with information enabling
PRESTWICK to negotiate in good faith with NEUROBIOTEC either (A) an amendment of this Agreement to
cover such compound or product or (B) a new agreement with respect to the development and
commercialization of such compound or product in the Prestwick License Region. NEUROBIOTEC agrees
to engage in such good faith negotiations if so requested by PRESTWICK. If PRESTWICK and
NEUROBIOTEC are not able to so amend this Agreement or so enter into a such a new agreement after
such negotiations within twelve (12) weeks as of commencing such negotiations, then NEUROBIOTEC
will not directly develop or commercialize such compound or product in the Prestwick License
Region, and if NEUROBIOTEC seeks to develop or commercialize such compound or product in the
Prestwick License Region indirectly through an agreement or other arrangement with a proposed
licensee, agent, representative or other third party and the terms of such agreement or other
arrangement are more favorable to such proposed licensee, agent, representative or other third
party than the terms of the agreement or other arrangement that NEUROBIOTEC had last offered to
PRESTWICK during the prior negotiations with PRESTWICK contemplated by the first sentence of this
Section 3.4, then PRESTWICK shall have the exclusive right but not the obligation to enter into
such an agreement or other arrangement with NEUROBIOTEC on such more favorable terms. If PRESTWICK
does not exercise this right within

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four (4) weeks as of having received such agreement or other arrangement, then NEUROBIOTEC
shall have the right to enter into such agreement or other arrangement with such proposed licensee,
agent, representative or other third party. For the avoidance of doubt, nothing in this Section 3.4
shall prohibit NEUROBIOTEC from developing or commercializing outside the Prestwick License Region
any compound or product in the nature of a dopamine agonist in any type of formulation.

     3.5 Not less than six (6) months prior to the anticipated date of the first Approval of a
Subject Project, the parties shall in good faith agree upon the marketing objectives for that
Subject Product in the territory where such Approval is expected.

4. Milestone Payments and Royalties

     4.1 Milestone Payments.

          (a) For the Initial Transdermal Indication. PRESTWICK shall pay to NEUROBIOTEC the
following amounts upon the occurrence of the indicated events relating to Subject Products for the
Initial Transdermal Indication and not formulated as IV and SC Formulations:

	 	(i)  	the earlier of (A) the [...***...] 
 for the purpose of [...***...] of the [...***...] of one of the [...***...] and
[...***...] or (B) [...***...] from the [...***...]: US$[...***...];
	 
	 	(ii)  	the earlier of (a) the [...***...] of an [...***...] for a [...***...] for the
[...***...] or (b) [...***...] from the [...***...]: US$[...***...];
	 
	 	(iii)  	[...***...] of a [...***...] for a [...***...] for the Initial Transdermal
Indication: US$[...***...];
	 
	 	(iv)  	[...***...] with the [...***...] of an [...***...] for a [...***...] for the Initial
Transdermal Indication: US$[...***...];
	 
	 	(v)  	[...***...] of the [...***...] by the [...***...] of a [...***...] for the Initial
Transdermal Indication: US$[...***...]; and
	 
	 	(vi)  	[...***...] in [...***...]: US$[...***...]

          (b) Milestone Payments for Subsequent Indications. In respect of each Subject Product
for indications referred to in the data transferred by NEUROBIOTEC to PRESTWICK or pursued by
PRESTWICK other than the Initial Transdermal Indication and in formulations other than IV and SC
Formulations referred to in the data transferred by NEUROBIOTEC to PRESTWICK or pursued by
PRESTWICK, PRESTWICK shall pay to NEUROBIOTEC upon the occurrence of the equivalent of the
indicated events for such indication and/or formulation [...***...] of the milestone payments set forth
in clauses (i) (A) and (ii) through (vi) of Section 4.1 (a) hereof, but for indications or
formulations [...***...] will be negotiated in good faith by NEUROBIOTEC and PRESTWICK, considering:
(A) the [...***...] of such Subject Product and (B) the [...***...] of [...***...].

          (c) Milestone Payments for the Initial IV and SC Indication. PRESTWCK shall pay to
NEUROBIOTEC the following amounts upon the occurrence of the indicated events relating to Subject
Products for the Initial IV and SC Indication:

	 	(i)  	[...***...] from the [...***...]: US$[...***...];

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	 	(ii)  	the earlier of (a) the [...***...] by the [...***...] of [...***...] for a [...***...]
for the Initial IV and SC Indication or (b) [...***...] from the [...***...]: US$[...***...];
	 
	 	(iii)  	[...***...] of a [...***...] for a [...***...] for the Initial IV and SC
Indication: US$[...***...];
	 
	 	(iv)  	[...***...] with the [...***...] of an [...***...] for a [...***...] for the Initial IV
and SC Indication: US$[...***...];
	 
	 	(v)  	[...***...] of the [...***...] by the [...***...] of a [...***...] for the Initial IV
and SC Indication: US$[...***...]; and
	 
	 	(vi)  	[...***...]in [...***...]: US$[...***...]

     4.2 Royalties Payable to NEUROBIOTEC.

          (a) Base Rate. Beginning with the First Commercial Sale in the Prestwick License
Region of a Subject Product by PRESTWICK or on behalf of Prestwick or by or on behalf of any of its
Affiliates or Sublicensees and for a period of ten (10) years thereafter, PRESTWICK shall pay to
NEUROBIOTEC [...***...] of the Net Sales of
Subject Products (such percentage being the “Base Rate”); provided, however, that if [...***...] or
[...***...] under the [...***...] or any [...***...] or [...***...]for any one or more of such [...***...] or
[...***...]under the [...***...] for such Subject Products in the [...***...] (collectively “Exclusivity”)
exceeds such ten-year period, then such royalty shall be paid beyond the tenth (10th)
anniversary of such First Commercial Sale [...***...] as of the [...***...] of such [...***...] to [...***...]
until the [...***...] the [...***...] of [...***...] in the [...***...] or the [...***...] of such [...***...], and such
[...***...] to [...***...] from and after such time; and further provided, however, that if such [...***...] to
the [...***...] of such [...***...], then the [...***...] shall be [...***...] as of the [...***...] of [...***...] to
[...***...] and such [...***...] to [...***...] upon [...***...].

          (b) Adjustments to Base Rate in Respect of Third Party Royalties. The Base Rate shall
be reduced to the extent PRESTWICK is required to pay and actually pays royalties on sales of
Subject Products to third parties (other than [...***...] to be paid to [...***...] and the [...***...] to be
paid to [...***...], but such reduction shall [...***...]; provided that if any such royalties to third
parties relate to avoidance of claims of infringement from such third parties relating to items
licensed by NEUROBIOTEC to PRESTWICK under this Agreement, then PRESTWICK shall promptly notify
NEUROBIOTEC of such claim, provide NEUROBIOTEC with copies of all correspondence relating to such
claim, not settle such claim or make any statement prejudicial to the defense or settlement of such
claim without according NEUROBIOTEC the opportunity to comment on such action or statement in
advance, permit NEUROBIOTEC to participate in all negotiations relating to such claim, and fully
inform NEUROBIOTEC on a timely basis of all actions taken in the defense and/or settlement of such
claim.

          (c) Adjustments to Base Rate in respect of Competition. The Base Rate in respect of
any Subject Product shall be reduced [...***...] any decline in Net Sales of PRESTWICK referred to
below in this subsection (c) to the extent that [...***...], but such reduction for such significant
competition shall not cause [...***...]. For purposes of the preceding sentence, [...***...] shall be
deemed to exist if following the introduction of [...***...] the Net Sales of PRESTWICK of the Subject
Product containing such Subject Compound decline [...***...], where such determination shall be made on
a [...***...].

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5. Reports and Payments

     5.1 Books of Accounts. PRESTWICK shall keep, and shall cause each of its Affiliates
and Sublicensees, if any, to keep full and accurate books of accounts containing all particulars
that may be necessary for the purpose of calculating or may under recognized accounting practices
contain information bearing upon the calculation of any and all royalties payable to NEUROBIOTEC
pursuant to Section 4 of this Agreement. Such books of account shall be kept at their principal
place of business and, with all necessary supporting data shall for the three (3) years next
following the end of the calendar year to which each shall pertain be open for inspection and audit
at reasonable times and/or PRESTWICK’s regular business hours, subject to receipt by PRESTWICK of
reasonable prior written notice, by NEUROBIOTEC or its designee at NEUROBIOTEC’s expense for the
purpose of verifying royalty statements or compliance with this Agreement; provided, however, any
such books of account and supporting data shall not be discarded and shall continue to be available
for inspection and audit in accordance with this Section 5.1 if at the end of such three-year
period in respect of such books of account and supporting data there is then an existing dispute or
an ongoing inspection or audit or a request by NEUROBIOTEC to perform such inspection or audit as
to the amount of royalties payable hereunder with respect to the period to which such books of
account or supporting data pertain. In the event that any audit performed under this Section 5.1
reveals an underpayment in excess of five percent (5%) of the total amount determined by the
auditor to be due NEUROBIOTEC, PRESTWICK shall bear the full cost of such audit and shall remit any
amounts due to NEUROBIOTEC within thirty (30) days of receiving notice thereof from NEUROBIOTEC.

     5.2 Quarterly Payments. In each year the amount of royalty due shall be calculated
quarterly as of March 31st, June 30th, September 30th and December
31st based on cash receipts from Net Sales and Sublicenses actually received during such
quarter and shall be paid quarterly in U.S. dollars within the sixty (60) days next following such
dates, every such payment to be supported by the accounting prescribed in Section 5.3.

     5.3 Accounting Reports. With each quarterly payment, PRESTWICK shall at its cost
deliver to NEUROBIOTEC a full and accurate accounting to include at least the following information
in respect of the then most recently ended quarter: the quantity of each Subject Product sold by
PRESTWICK and its Affiliates or Sublicensees (by country); the gross sales price billed and Net
Sales Price received by PRESTWICK or any of its Affiliates or Sublicensees from the sale of each
Subject Product (by country); and total royalties payable to NEUROBIOTEC. With every quarterly
payment in respect of each quarter ended December 31st, PRESTWICK shall at its cost
deliver to NEUROBIOTEC a consolidated annual royalty report for the immediately preceding calendar
year with the same information, such report to be audited and certified by a certified public
accountant reasonably acceptable to NEUROBIOTEC.

6. Patents

     6.1 Infringement of Subject Patents. If PRESTWICK shall have supplied NEUROBIOTEC with
written evidence demonstrating prima facie infringement of a claim of a Subject Patent by a third
party in the Prestwick License Region, NEUROBIOTEC shall notify PRESTWICK within
[...***...] of being provided with evidence of
infringement whether NEUROBIOTEC intends to prosecute the alleged infringement. If NEUROBIOTEC
notifies PRESTWICK that it intends to so prosecute, NEUROBIOTEC shall, within [...***...] of its notice
either (i) cause such infringement to terminate or (ii) initiate and prosecute legal proceedings
against the infringer. If NEUROBIOTEC decides to prosecute such legal proceedings against such
infringer, NEUROBIOTEC shall at Prestwick’s expense provide PRESTWICK with copies of all pleadings,
motions and other documents relating to such prosecution reasonably prior to the filing thereof
with the applicable court or judicial body or delivery thereof to the alleged infringer so

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that PRESTWICK may provide comments to NEUROBIOTEC relating thereto, and PRESTWICK shall have
the right to consult with NEUROBIOTEC relating to such prosecution and participate in such legal
proceedings at PRESTWICK’s expense with counsel of PRESTWICK’s choice; provided, however, if
NEUROBIOTEC reasonably concludes that any action relating to such prosecution and legal proceedings
needs to be taken before completing any such consultation with PRESTWICK, NEUROBIOTEC may do so. In
the event NEUROBIOTEC notifies that NEUROBIOTEC does not intend to prosecute said infringement,
PRESTWICK may, upon notice to NEUROBIOTEC initiate its own legal proceedings against the infringer
at PRESTWICK’s expense. No settlement, consent judgment or other voluntary final disposition of the
suit which invalidates or restricts the claims of such Subject Patent in the Prestwick License
Region may be entered into without the consent of the other party, which consent shall not be
unreasonably withheld, but provided that, in the event one party (“the Objecting Party”) withholds
consent for a proposed settlement, the party proposing the settlement may decline to support
further costs of such suit or settlement discussions, and the Objecting Party shall be required to
continue such suit or settlement discussions at its own expense. PRESTWICK shall indemnify
NEUROBIOTEC against any order for payment that may be made against NEUROBIOTEC in such proceedings
brought by PRESTWICK. NEUROBIOTEC shall indemnify PRESTWICK against any order for payment that may
be made against PRESTWICK in such proceedings which NEUROBIOTEC brings at its own expense pursuant
to this Section 6.1 following PRESTWICK’s decision not to prosecute any alleged infringement.

     6.2 Cooperation. In the event one party shall initiate or carry on legal proceedings
to enforce any Subject Patent against any alleged infringer, the other party shall fully cooperate
with and supply all assistance reasonably requested by the party initiating or carrying on such
proceedings. The party that institutes any suit to protect or enforce a Subject Patent Right shall
have sole control of that suit and shall bear the reasonable expenses (excluding legal fees)
incurred by said other party in providing such assistance and cooperation as is requested pursuant
to this Section. The party initiating or carrying on such legal proceedings shall keep the other
party informed of the progress of such proceedings and said other party shall be entitled to
counsel in such proceedings but at its own expense. Any award paid by third parties as the result
of such proceedings (whether by way of settlement or otherwise) shall first be applied to
reimbursement of the unreimbursed legal fees and expenses incurred by either party and then the
remainder shall be divided between the parties as follows:

          (a) If the amount is based on lost profits, PRESTWICK shall receive an amount equal to the
damages the court determines PRESTWICK has suffered as a result of the infringement less the amount
of any royalties that would have been due NEUROBIOTEC on sales of Subject Product lost by PRESTWICK
as a result of the infringement had PRESTWICK made such sales, and NEUROBIOTEC shall receive an
amount equal to the royalties it would have received if such sales had been made by PRESTWICK, and

          (b) As to
awards other than those based on lost profits, [...***...] to [...***...] and [...***...] to [...***...].

     6.3 Infringement Actions by Third Parties. In the event that the manufacture, use,
sale or import of a Subject Product in the Prestwick License Region by or in behalf of PRESTWICK
infringes the intellectual property rights of others, PRESTWICK will have the first right to
control any negotiation or litigation with respect thereto.

     6.4 Further Assurances; Progress Reports. For the purpose of the proceedings referred
to in this Article 6, NEUROBIOTEC and PRESTWICK shall permit the use of their names and shall
execute such documents and carry out such other acts as may be necessary. The party initiating or
carrying on such legal proceedings shall keep the other party informed of the progress of such
proceedings and said other

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party shall be entitled to counsel in such proceedings but at its own expense, said expenses
to be offset against any damages received by the party bringing any infringement suit against a
third party in accordance with Section 6.2.

     6.5 Subject to Schering’s rights under the TTA, if NEUROBIOTEC decides at any time during the
term of this Agreement to no longer pursue, maintain or defend any of the Subject Intellectual
Property, including, without limitation, the Transferred Schering Technology and the NeuroBiotec
Licensed Technology, and further including, without limitation, new and supplementary patent
applications thereto and any patent and Know-How applied for or granted to it independently of
SCHERING developed by NEUROBIOTEC, then NEUROBIOTEC will promptly inform PRESTWICK of such decision
prior to allowing any patent or other intellectual property rights therein to lapse and shall
promptly provide PRESTWICK at PRESTWICK’s expense with information which in the reasonable
judgement of NEUROBIOTEC enables PRESTWICK to negotiate in good faith with NEUROBIOTEC the
acquisition of NEUROBIOTEC’s ownership rights to the Subject Intellectual Property. NEUROBIOTEC
agrees to engage in such good faith negotiations if so requested by PRESTWICK. If PRESTWICK and
NEUROBIOTEC are not able to so amend this Agreement or so enter into a such a new agreement
relating to such acquisition within twelve (12) weeks as of NEUROBIOTEC having so informed
PRESTWICK and having provided PRESTWICK with such information, and NEUROBIOTEC then seeks to
dispose of such ownership rights through a proposed agreement or other arrangement with a third
party and the terms of such proposed agreement or other arrangement are more favorable to such
third party than the terms of the agreement or other arrangement that NEUROBIOTEC had last offered
to PRESTWICK during the prior negotiations with PRESTWICK contemplated by the immediately preceding
sentence, then PRESTWICK shall have the exclusive right but not the obligation to enter into such
an agreement or other arrangement with NEUROBIOTEC on such more favorable terms. If PRESTWICK does
not exercise this right within four (4) weeks as of having received notice of such agreement or
other arrangement, then NEUROBIOTEC shall have the right to enter into such agreement or
arrangement regarding such ownership interest with a third party.

7. Information on Drug Safety

     7.1 The parties agree to keep each other informed without any undue delay on all matters
relating to the safety of the Subject Compounds, Subject Formulations and Subject Products,
including, without limitation, Adverse Drug Experiences, Serious Adverse Drug Experiences and
Life-Threatening Adverse Drug Experiences, and all correspondence from authorities or measures
taken by the registration holder with regard to the safety of the Subject Compounds, Subject
Formulations and Subject Products. Each party agrees to provide the other party such information in
a timely and prompt manner so that such other party may comply with various applicable laws and
regulations relating to the disclosure of such information to the drug regulatory authorities to
which such other party is subject.

     7.2 The parties shall keep each other informed on their product labels for the Subject
Products and instructions for use leaflets. In case of discrepancies between their respective
product labels and instructions for use leaflets, NEUROBIOTEC and PRESTWICK shall be obliged to
resolve these discrepancies in the interest of a homogenous approach to drug safety and with regard
to their relationships with relevant regulatory authorities.

8. Representations and Warranties; Covenants

     8.1 NEUROBIOTEC hereby represents and warrants and covenants:

          (a) that to the best of its knowledge the development or use of the Subject Intellectual
Property by or for NEUROBIOTEC and the development, use, manufacture, marketing, sale or import of
Subject Compounds, Subject Formulations and Subject Products and any associated know-how, data,
derivatives,

 19.

 

parts and progeny thereof conducted by or for NEUROBIOTEC, including the manufacture of such
Subject Compounds, Subject Formulations and Subject Products by the Third Party Manufacturers, has
been in compliance with all applicable laws and regulations to which PRESTWICK or such Subject
Compounds, Subject Formulations or Subject Products will be subject in the Prestwick License
Region, including, without limitation, the Good Manufacturing Practices and other rules and
regulations promulgated by the FDA, or with respect to which the absence of compliance on the part
of the Third Party Bulk Drug Substance Manufacturer or the Third Party Formulation Manufacturer, as
applicable, would adversely affect the supply to PRESTWICK of Subject Compounds, Subject
Formulations or Subject Products otherwise contemplated by this Agreement;

          (b) that NEUROBIOTEC shall, if and when any development or use of the Subject Intellectual
Property by or for NEUROBIOTEC and any development, use, manufacture, marketing, sale or import of
Subject Compounds, Subject Formulations and Subject Products and any associated know-how, data,
derivatives, parts and progeny thereof conducted by or for NEUROBIOTEC, is not in compliance with
all applicable laws and regulations to which PRESTWICK or such Subject Compounds, Subject
Formulations or Subject Products will be subject in the Prestwick License Region, including,
without limitation, the Good Manufacturing Practices and other rules and regulations promulgated by
the FDA, or with respect to which the absence of compliance on the part of the Third Party Bulk
Drug Substance Manufacturer or the Third Party Formulation Manufacturer, as applicable, would
adversely affect the supply to PRESTWICK of Subject Compounds, Subject Formulations or Subject
Products otherwise contemplated by this Agreement promptly take all actions available and in
accordance with the Third Party Agreements and under applicable law to ensure such compliance;

          (c) that it will inform PRESTWICK without any undue delay of any plans to amend the TTA, the
Third Party Formulation Agreement or the Third Party Bulk Drug Substance Agreement, if and to the
extent that amendment could directly or indirectly impact the ability of NEUROBIOTEC to perform its
obligations to PRESTWICK under this Agreement or adversely affect the supply to PRESTWICK of
Subject Compounds, Subject Formulations or Subject Products contemplated by this Agreement;

          (d) that it will provide to PRESTWICK any and all benefits accruing to NEUROBIOTEC under the
TTA, the Third Party Bulk Drug Substance Agreement and the Third Party Formulation Agreement for
purposes of the Development Program and PRESTWICK’s practice of the licenses granted by NEUROBIOTEC
to PRESTWICK hereunder, provided that NEUROBIOTEC shall not be required under this clause (d) to
contravene any term or condition in the TTA, the Third Party Bulk Drug Agreement and the Third
Party Formulation Agreement;

          (e) NEUROBIOTEC is the owner of the Subject Intellectual Property existing as of the Effective
Data; provided, however, that NEUROBIOTEC neither makes any representation or warranty as to the
merchantability or fitness for any use of the Subject Intellectual Property and any associated
know-how, data, derivatives, parts and progeny thereof, nor as to the absence of any third party
rights to the Subject Intellectual Property or any other interfering rights of third parties;

          (f) to the best of NEUROBIOTEC’s knowledge, there is no fact or circumstance that is likely to
prevent or materially delay the acceptance, or the subsequent approval, by any regulatory authority
in the Prestwick License Territory of any filing, application or request (including pricing and
reimbursement approval) with respect to the development or commercialization of any Subject
Compound, Subject Formulation or Subject Product existing on the Effective Date;

          (g) except for patent prosecution proceedings relating to the pending patent applications
included in the Subject Patents, (i) there are to the best of NEUROBIOTEC’s knowledge no legal or
governmental proceedings pending or threatened relating to the validity, enforceability, scope or
similar aspect of the Subject Patents and NEUROBIOTEC has not received notice that any such
proceedings are pending or

 20.

 

have been threatened against NEUROBIOTEC, (ii) to the best of NEUROBIOTEC’s knowledge no such
proceedings, including, without limitation, interference or opposition proceedings, are currently
threatened or contemplated by governmental authorities or others, and (iii) to the best of
NEUROBIOTEC’s knowledge none of the Subject Compounds, Subject Formulations, Subject Products,
Subject Patents, Subject Intellectual Property is the subject of any current claim or notice of
infringement or other violation of any patents, trade secrets or other intellectual property owned
by third parties;

          (h) NEUROBIOTEC is not aware of any basis on which a court would find invalid or
unenforceable, or on which the U.S. Patent & Trademark Office (the “PTO”) or any non-U.S.
counterpart of the PTO would revoke, any issued patents included in the Subject Patents or,
assuming allowance of the claims in the pending applications included in the Subject Patents, any
letters patent issuable in respect of such pending applications; and NEUROBIOTEC is not aware of
any basis on which the claims in any such pending application would not be allowed by the PTO or
any non-U.S. counterpart of the PTO; all of the necessary documents required under applicable law
or regulation in connection with the prosecution of any of the Subject Patents have been timely and
properly filed in accordance with such law and regulation; all filing fees and maintenance fees
required under applicable law or regulation in respect of any of the Subject Patents have been
timely paid.

          (i) except for Schering’s rights under the Schering Options, NEUROBIOTEC is not aware of (A)
any basis for a finding that NEUROBIOTEC does not have clear right, title and interest to the
Subject Intellectual Property or (B) the assertion by any third parties of ownership rights in the
Subject Intellectual Property; NEUROBIOTEC shall not knowingly take any action that would encumber
the rights granted to PRESTWICK hereunder which limit the use of the Subject Intellectual Property
by PRESTWICK as contemplated hereunder;

          (j) NEUROBIOTEC is not aware of any actual or threatened infringement by a third party of the
Subject Intellectual Property or of any third party rights to the Subject Intellectual Property
which limit the use of the Subject Intellectual Property by PRESTWICK as contemplated hereunder.

     8.2 PRESTWICK hereby represents and warrants and covenants:

          (a) that any development or use of the Subject Intellectual Property by or for PRESTWICK and
any development, use, manufacture, marketing, sale or import of Subject Compounds, Subject
Formulations and Subject Products and any associated know-how, data, derivatives, parts and progeny
thereof conducted by or for PRESTWICK will be in compliance with all applicable laws and
regulations; provided that as between PRESTWICK and NEUROBIOTEC, NEUROBIOTEC shall be responsible
for monitoring and seeking compliance in accordance with sec. 8.1 (b) above by the Third Party
Manufacturers with the GMP standards required by the FDA in respect of the supply of Subject
Compounds, Subject Formulations and Subject Products provided to PRESTWICK hereunder for the
purpose of conducting Clinical Trials, and in the event that NEUROBIOTEC becomes aware of any
actual or perceived lack of such compliance, NEUROBIOTEC will immediately notify PRESTWICK thereof;

          (b) all of the right, title and interest in any agreement by and between any Affiliate of
PRESTWICK and NEUROBIOTEC that relates to the Subject Intellectual Property has been assigned to
PRESTWICK.

     8.3 PRESTWICK acknowledges that NEUROBIOTEC has not conducted research into the matters and
circumstances as to which NEUROBIOTEC makes representations subject to its “best knowledge” or its
being “aware” of such matters and circumstances. Such best knowledge or awareness of NEUROBIOTEC
shall therefore only be deemed present if such matters are actually known to

 21.

 

NEUROBIOTEC and shall not include matters which could or should have been known to
NEUROBIOTEC.

9. Limited Liability and Indemnification

     9.1 Limitation of Liability and Indemnification.

          (a) No claim of PRESTWICK shall be based on circumstances disclosed or otherwise known to
PRESTWICK prior to the execution of this Agreement. Circumstances shown or referenced in the
documentation and other information made available to PRESTWICK as part of PRESTWICK’s due
diligence review of NEUROBIOTEC shall be deemed known to PRESTWICK for purposes of this Agreement.

          (b) All claims arising under sections 8 and/or 9 of this Agreement which pertain to matters or
circumstances present at the Effective Date shall be [...***...] as of [...***...] (i) [...***...] after the [...***...] or (ii) [...***...] as of [...***...].
Settlement or similar discussions between the parties shall not [...***...].

          (c) No liability under sections 8 and/or 9 of this Agreement shall arise for either party to
the extent that the aggregate amount of all claims of the other party [...***...] (herein referred to
as the [...***...]). In case the aggregate amount of all claims of the claiming party is [...***...], the
liability shall be the aggregate amount of all claims [...***...]. This limitation shall not apply to
all claims of a party arising as a result of willful or intentional breaches of such party’s
obligations under this Agreement.

          (d) Any development, manufacture, use, marketing, sale or import by or for PRESTWICK of
Subject Products, or any associated Subject Intellectual Property, data, derivatives, parts and
progeny thereof, shall be the sole responsibility of PRESTWICK, except as expressly otherwise
provided in this Agreement.

          (e) Any development, manufacture, use, marketing, sale or import by or for NEUROBIOTEC of
Subject Products or any associated Subject Intellectual Property, data, derivatives, parts and
progeny thereof, shall be the sole responsibility of NEUROBIOTEC, except as expressly otherwise
provided in this Agreement.

     9.2 Indemnification, Generally.

          (a) PRESTWICK shall indemnify NEUROBIOTEC and hold NEUROBIOTEC harmless against any and all
claims for damages or losses or any other claims made against NEUROBIOTEC or its Affiliates by
third parties arising out of any breach of PRESTWICK’s representations, warranties and/or covenants
as per Section 8 hereof; provided that such indemnity shall not apply to any such claims or losses
caused by the negligence or willful misconduct by or for NEUROBIOTEC.

          (b) NEUROBIOTEC shall indemnify PRESTWICK and hold PRESTWICK harmless against any and all
claims for damages or losses or any other claims made against PRESTWICK or its Affiliates by third
parties arising out of any breach of NEUROBIOTEC’s representations, warranties and/or covenants as
per Section 8 hereof; provided that such indemnity shall not apply to any such claims or losses
caused by the negligence or willful misconduct by or for PRESTWICK.

	*	 	Confidential Treatment Requested

 22.

 

     9.3 Indemnification Limitations and Procedures.

          (a) No Indemnitee under Sections 9.2 or 9.3 shall be entitled to any indemnification under
such clause for any Loss to the extent that such Loss is attributable to the negligent activities,
reckless misconduct or intentional misconduct of such Indemnitee.

          (b) Any Indemnitee under Section 9.2 or 9.3 shall give the party from whom indemnification
under such clause is sought (the “Indemnitor”) prompt written notice of any Losses or discovery of
fact upon which such Indemnitee intends to base a request for indemnification under such clause,
provided, however, that an Indemnitor’s obligations to such Indemnitee under Section 9.2 or 9.3, as
applicable, shall not be rendered inapplicable as a result of the failure by such Indemnitee to
notify such Indemnitor as required under this Section 9.5, unless such failure materially
prejudices such Indemnitor’s ability to take action with respect to any such Loss.

          (c) Each Indemnitor under Section 9.2 or 9.3, as applicable, agrees, at its own expense, to
provide attorneys reasonably acceptable to an Indemnitee to defend against any actions brought or
filed against such Indemnitee with respect to the subject of indemnity contained herein, whether or
not such actions are rightfully brought. Each Indemnitee under Section 9.2 or 9.3, as applicable,
shall be entitled to participate in, but not control, the defense of such action and to employ
counsel of its own choice for such purpose; provided, however, that such employment shall be at
such Indemnitee’s own expense.

          (d) each Indemnitor shall have the sole right to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of any Loss, on such terms as such Indemnitor, in its sole
discretion, shall deem appropriate.

     9.4 Insurance.

          (a) In respect of the period specified in Section 9.5(c), PRESTWICK and NEUROBIOTEC shall
each, at its sole cost and expense, procure and maintain commercial general liability insurance in
amounts not less than [...***...]. Such
commercial general liability insurance shall provide product liability coverage and broad form
contractual liability coverage for such party’s indemnification under Sections 9.2 or 9.3 of this
Agreement, as applicable. If a party elects to self-insure all or part of the limits described
above (including deductibles or retentions which are in excess of [...***...] such self-insurance
program must be acceptable to the other party. The minimum amounts of insurance coverage required
under this Section 9.5 shall not be construed to create a limit of either party’s liability with
respect to such party’s indemnification under Section 9.2 or 9.3, as applicable, of this Agreement.

          (b) Each party shall provide the other party with written evidence of such insurance upon
request of the other party. Each party shall provide the other party with written notice at least
fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance.

          (c) The period in respect of which each party shall maintain the insurance required under
Section 9.5 shall begin at the time of the First Commercial Sale of a Subject Product and shall end
upon termination of this Agreement.

     9.5 The foregoing provisions of this Article 9 shall not affect any claims for damages or
losses which either party may have under the applicable German law.

	*	 	Confidential Treatment Requested

 23.

 

10. Confidentiality

     This Agreement and all matters undertaken with respect hereto shall be considered as
“confidential information” under the TTA and that certain Confidentiality Agreement, dated March
16, 2002, between NEUROBIOTEC and PRESTWICK Scientific Capital Inc., as amended on October 7, 2002
to include PRESTWICK Companies, Inc. as a party thereto and as further amended on May 13, 2003 to
include PRESTWICK as a party thereto.

11. Duration and Termination

     11.1 This Agreement shall come into effect on the Effective Date and shall remain in force and
effect until (a) fifteen (15) years from the First Commercial Sale in the United States of America
or (b) the last to expire of any patent covering the Subject Compound and/or the Subject Products
licensed by NEUROBIOTEC to PRESTWICK under this Agreement or of Exclusivity, whichever is the later
to occur. Upon such termination, the licenses granted to either party under this Agreement shall
become fully paid, perpetual, and non-terminable.

     11.2 The foregoing provisions of this Article 11 shall not affect any termination rights which
either party may have under the applicable German law and the following provisions:

          (a) Failure by either party (the “defaulting party”) to comply with any of the material
obligations contained in this Agreement shall entitle the other party (the “nondefaulting party”)
to give the defaulting party notice specifying the nature of the default and requiring the
defaulting party to cure such default. If such default is not cured within the
[...***...] period after the receipt of such
notice, the nondefaulting party shall be entitled, except as otherwise specifically provided in
this Agreement and without prejudice to any of its other rights conferred on it by this Agreement,
(i) if such noncompliance is likely to have a material adverse effect of the nondefaulting party to
terminate all or part of this Agreement or the licenses granted herein, and to suspend payment of
any royalties or other amounts then or thereafter due hereunder until such default has been cured;
or (ii) proceed in accordance with sec. 12 hereof.

          (b) Either party may, in addition to any other remedies available to it, terminate this
Agreement, in whole or in part as the terminating party may determine, by written notice to the
other party in the event the other party shall have become insolvent or bankrupt, or there shall
have been appointed a trustee or receiver for the other party or for all or a substantial part of
its property, or any case or proceeding shall have been commenced or other action taken by or
against the other party in bankruptcy or seeking reorganization, liquidation, dissolution,
winding-up, arrangement, composition or readjustment of its debts or any other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or
hereafter in effect, or there shall have been issued a warrant or attachment, execution, distraint
or similar process against any substantial part of the property of the other party, and any such
event shall have continued for [...***...] undismissed, unbonded and undischarged; except that the
terminating party shall retain the rights granted to it as a licensee under Section 365(n) of the
United States Bankruptcy Code in case of the bankruptcy, insolvency or winding-up of the other
party.

     11.3 The provisions of Articles 8 (Representations and Warranties), 9 (Liability and
Indemnification), 10 (Confidentiality) and 14.9 (Governing Law) shall survive termination for any
reason whatsoever.

	*	 	Confidential Treatment Requested

 24.

 

12. Alternate Dispute Resolution

     All disputes arising in connection with this Agreement or its validity shall be finally
settled according to the Arbitration Rules of the German Institution of Arbitration e.V. (DIS)
without recourse to the ordinary courts of law. The place of arbitration is Zurich/Switzerland. The
arbitral tribunal consists of three arbitrators. The arbitration proceedings shall be conducted in
the English language. Nothing in this section shall prevent either party from seeking injunctive or
other equitable relief from any court of competent jurisdiction if that party in its absolute
discretion deems such relief necessary for the protection of its Confidential Information or
Intellectual Property Rights.

13. Limitation of NEUROBIOTEC’s Obligations on Account of the TTA

     The parties acknowledge that any and all PRESTWICK’s rights and/or of NEUROBIOTEC’s
obligations under this Agreement shall be subject to the requirement and shall only exist to the
extent that PRESTWICK’s exercise of its rights and/or NEUROBIOTEC’s fulfilling of its obligations
does not constitute a breach of its obligations under or does not otherwise conflict with the TTA
or the Third Party Agreements.

14. Miscellaneous

     14.1 Assignment. This Agreement, its rights and obligations, shall not be assignable
or transferable by either party to any third party without the prior written consent of the other
party; provided, however, that either party may with the prior written consent of the other party,
such consent not to be unreasonably withheld, assign its rights under this Agreement to an
affiliate of the assigning party, any party that acquires all or substantially all of the assets of
the assigning party or any surviving company following a consolidation or merger of the assigning
party with or into another corporation or other entity.

     14.2 Notices. All notices and other communications required or permitted under this
Agreement shall be in writing and shall be sent by registered or certified mail (return receipt
requested and postage a prepaid), transmitted by facsimile, or delivered by hand, by messenger or
by a recognized overnight delivery service, addressed to each party as follows:

	 	 	 
	if to NEUROBIOTEC:

	 	NeuroBiotec GmbH
	

	 	Tegeler Str. 6
	

	 	13353 Berlin
	

	 	Germany
	

	 	Attention: Geschäftsfuhrung
	

	 	Telephone: +49 30 460 619 1l
	

	 	Facsimile: +49 30 460 619 22

with a copy to (which shall not constitute notice):

	 	 	 
	

	 	Rechtsanwalt Hargo Maluch
	

	 	Kurfurstendamm 177
	

	 	10707 Berlin
	

	 	Germany
	

	 	Telephone: +49 30 880 30 40
	

	 	Facsimile: +49 30 880 30 435

if to PRESTWICK:

	 	 	 
	

	 	Prestwick Pharmaceuticals, Inc.
	

	 	1825 K Street, N.W.

 25.

 

	 	 	 
	

	 	Washington, D.C. 20006
	

	 	USA
	

	 	Attention: President
	

	 	Telephone: +1 202 296-1400
	

	 	Facsimile: +1 202 296-7450

Each such notice or other communication shall for all purposes of this Agreement be treated as
effective or having been given in accordance with German law.

     14.3 Entire Agreement. This Agreement, together with the Appendices and Schedules
hereto as such Appendices and Schedules may be amended from time to time in accordance with this
Agreement contains the entire agreement between the parties with respect to the subject matter
thereof. Any prior agreement, arrangement or undertaking, whether oral or in writing, is hereby
superseded.

     14.4 Amendments. No amendment, modification or addition hereto shall be effective or
binding on either party unless set forth in writing and executed by duly authorized representatives
of both parties. Thus includes amendments, modifications and additions to this clause.

     14.5 Counterparts. This Agreement may be executed in counterparts, all of which
constitute one and the same agreement.

     14.6 Expenses. Each party shall bear all of the expenses it incurs in connection with
the negotiation of this Agreement and the TTA Amendment.

     14.7 Transfer of Funds. All payments by one party to the other party have to be made
at no cost for the other party by bank transfer of immediately available funds to a bank account in
the US or Europe designated by the other party.

     14.8 Force Majeure. No party shall be liable for any failure or delay in performance
under this Agreement to the extent such failure or delay arises from any cause of any nature beyond
the reasonable control of such party, and which would render performance hereunder impossible
including without in any way limiting the generality of the foregoing, fire, explosion, earthquake,
storm, flood, strike, labor difficulties, war insurrection, riot, act of God, or any law, act,
order, export or import control regulations, proclamation, decree, regulation, ordinance or
instructions of local, state, federal or foreign governmental or other public authorities, or
judgment or decree of a court of competent jurisdiction and not otherwise arising out of breach by
such party of this Agreement.

     14.9 Governing Law and Jurisdiction. This Agreement shall be governed by, subject to
and construed in accordance with the laws of Germany without its provisions of conflict of laws and
the Vienna Convention of 1980 (“The Convention on Contracts for the International Sale of Goods”)
and all domestic implementations of that Convention. Each party hereby consents, subject to Section
12 (Alternate Dispute Resolution) of this Agreement, to the exclusive jurisdiction of the courts in
the City of Zurich/Switzerland.

 26.

 

     IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly
authorized representatives; as of the date first written above.

	 	 	 	 	 	 	 
	NeuroBiotec GmbH	 	Prestwick Pharmaceuticals, Inc.
	 
	 	 	 	 	 	 
	

	 	 	 		 	 
	By:	 	Richard
Horowsky /s/	 	By:	 	Robert S. Whitehead /s/
	

	 	Name:
	 	 	 	Name:
	

	 	Title:
	 	 	 	Title:

 27.

 

List of Appendices

	 	 	 
	1.

	 	Appendices Referenced in Article 1
	1.0

	 	Definitions and Provisions from Applicable US Laws and Regulations
	1.1

	 	Development Program
	1.2

	 	NeuroBiotec Existing Data
	1.3

	 	NeuroBiotec Existing Improvements
	1.4

	 	NeuroBiotec Patents
	1.5

	 	Schering Existing Data
	1.6

	 	Schering Patents
	1.7

	 	Third Party Bulk Drug Substance Agreement
	1.8

	 	Third Party Formulation Agreement
	1.9

	 	TTA and Amendments thereto
	 
	 	 
	3.

	 	Appendices Referenced in Article 3
	3.3

	 	Clinical Supply Terms

 1.

 

APPENDIX 1.0 Definitions and Provisions from Applicable US Laws
and Regulations

1

 

[Code of Federal Regulations]

[Title 21 Volume 5]

[Revised as of April 1, 2003]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR310.305] [Page 18-21] TITLE 21—FOOD AND DRUGS CHAPTER I—FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 310—NEW DRUGS—Table of Contents Subpart
D—Records and Reports

Sec. 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs
for human use without approved new drug applications.

(b) Definitions. The following definitions of terms apply to this section:

Adverse drug experience. Any adverse event associated with the use of a drug in humans, whether or
not considered drug related, including the following: An adverse event occurring in the course of
the use of a drug product in professional practice; an adverse event occurring from drug overdose
whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event
occurring from drug withdrawal; and any failure of expected pharmacological action.

Disability. A substantial disruption of a person’s ability to conduct normal life functions.

Life-threatening adverse drug experience. Any adverse drug experience that places the patient, in
the view of the initial reporter, at immediate risk of death from the adverse drug experience as it
occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more
severe form, might have caused death.

Serious adverse drug experience. Any adverse drug experience occurring at any dose that results in
any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient
hospitalization or prolongation of existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not
result in death, be life-threatening, or require hospitalization may be considered a serious
adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the
patient or subject and may require medical or surgical intervention to prevent one of the outcomes
listed in this definition. Examples of such medical events include allergic bronchospasm requiring
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not
result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Unexpected adverse drug experience. Any adverse drug experience that is not listed in the current
labeling for the drug product. This includes events that may be symptomatically and
pathophysiologically related to an event listed in the labeling, but differ from the event because
of greater severity or specificity. For example, under this definition, hepatic necrosis would be
unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic
enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be
unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular
accidents.

“Unexpected,” as used in this definition, refers to an adverse drug experience that has not been
previously observed (i.e., included in the labeling) rather than from the perspective of such
experience not being anticipated from the pharmacological properties of the pharmaceutical product.

1.

 

APPENDIX 1.1 Development Program

1.

 

Appendix 1.1

Development Program

This Appendix 1.1 is to that certain Development and Commercialization License and Clinical Supply
Agreement, dated as September 10, 2003 (the “Agreement”), by and between NeuroBiotec GmbH,
Berlin/Germany, a company formed under the laws of Germany (“NeuroBiotec), and Prestwick
Pharmaceuticals, Inc., a company formed under the laws of Delaware (“Prestwick”). As such, this
Appendix 1.1 sets forth the Development Program, as defined in the Agreement. Capitalized terms
used but not defined in this Appendix 1.1 shall have the meanings given to them in the Agreement.

Introduction 

[...***...]

Transdermal Formulation 

[...***...]

Non-Transdermal Formulation 

[...***...]

*Confidential Treatment
Requested

1.

 

APPENDIX 1.2 NeuroBiotech Existing Data

1.

 

NeuroBiotec Existing Data (according definition §1, page 4 of proposed DCL and CS
Agreement between NeuroBiotec GmbH and Prestwick Pharmaceuticals, Inc.

A. CMC Documents

A.l. Drug Substance(s)

A.1.1. Lisuride [...***...]

     [...***...]

A.1.2. Lisuride Hydrogenmaleate [...***...]

     [...***...]

B.1. Drug Product(s)

B1.1. Lisuride Patch [...***...]

B.1.2. Lisuride Patch [...***...]

B.2.1. Lisuride iv/sc [...***...]

C. Bioanalytical Data

C.1. Radioimmunoassay for Lisuride

[...***...]

C.2. LC/MS/MS Method for Lisuride

[...***...]

D. Pharmacokinetic Data

[...***...]

E. Clinical Studies

[...***...]

F. General Documentation

[...***...]

*Confidential Treatment
Requested

1.

 

APPENDIX 1.3 NeuroBiotech Existing Improvements

1.

 

NeuroBiotec Existing Improvements

(refers to Appendix 1.3 of the proposed License Agreement between Prestwick and NeuroBiotec
(NBt))

Statements/Comments:

[...***...]

Dr. Johannes Tack

September 15, 2003

*Confidential Treatment
Requested

1.

 

CERTIFICATE OF ANALYSIS

	 	 	 
	Product:

	 	[...***...]
	Batch:

	 	[...***...]
	Quantity:

	 	[...***...]

Structure formula:

[DIAGRAM OF MOLECULE]

	 	 	 	 	 
	Parameter	 	Method	 	Found
	Identity:

	 	[...***...]	 	 
	Assay:

	 	[...***...]	 	 
	Purity:

	 	[...***...]	 	 

Individual impurities: HPLC – [...***...]

Date: June 6, 2002

	 	 	 
	Signature:

	 	Dr. Miroslav Flieger
	

	 	Institute of Microbiology, CAS
	

	 	Videnske 1083, Prague 4, 14220
	

	 	Czech Republic

*Confidential Treatment
Requested

 

 

Sample Information

Sample Set Name purity test

	 	 	 	 	 	 	 
	Sample Name

	 	[...***...]
	 	Date Acquired:
	 	[...***...]
	Batch Number

	 	[...***...]
	 	Acq Method Set
	 	[...***...]
	Injection Volume

	 	[...***...]
	 	Processing Method
	 	[...***...]]
	Run Time

	 	[...***...]	 	 	 	 
	 
	 	 	 	 	 	 
	Analytical conditions:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Column

	 	[...***...]	 	 	 	 
	Flow rate

	 	[...***...]	 	 	 	 
	Mobile phase

	 	[...***...]	 	 	 	 
	

	 	[...***...]	 	 	 	 
	_etection

	 	[...***...]	 	 	 	 
	Temperature

	 	[...***...]	 	 	 	 

[...***...]

Peak Results

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	Name	 	 	RT	 	 	Area	 	 	% Area	 
	 	 

	 	 	 	 	 	[...***...]	 	 	 	 	 	 	 
	 	2

	 	 	 	 	 	[...***...]	 	 	 	 	 	 	 
	 	3

	 	 	 	 	 	[...***...]	 	 	 	 	 	 	 
	 	4

	 	 	 	 	 	[...***...]	 	 	 	 	 	 	 
	 	5

	 	 	 	 	 	[...***...]	 	 	 	 	 	 	 
	 	6

	 	 	 	 	 	[...***...]	 	 	 	 	 	 	 
	 

*Confidential Treatment
Requested

 

 

Sample Information

Sample Set Name purity test

	 	 	 	 	 	 	 
	Sample Name

	 	[...***...]
	 	Date Acquired:
	 	[...***...]
	Batch Number

	 	[...***...]
	 	Acq Method Set
	 	[...***...]
	Injection Volume

	 	[...***...]
	 	Processing Method
	 	[...***...]
	Run Time

	 	[...***...]	 	 	 	 
	 
	 	 	 	 	 	 
	Analytical conditions:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Column

	 	[...***...]	 	 	 	 
	Flow rate

	 	[...***...]	 	 	 	 
	Mobile phase

	 	[...***...]	 	 	 	 
	

	 	[...***...]	 	 	 	 
	_etection

	 	[...***...]	 	 	 	 
	Temperature

	 	[...***
...]
	 		 	 

[GRAPH – Auto-Scaled Chromatogram]

Peak Results

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	Name	 	 	RT	 	 	Area	 	 	% Area	 
	 	1

	 	 	 	 	 	[...***...]	 	 	[...***...]	 	 	[...***...]	 
	 	2

	 	 	 	 	 	[...***...]	 	 	[...***...]	 	 	[...***...]	 
	 	3

	 	 	 	 	 	[...***...]	 	 	[...***...]	 	 	[...***...]	 
	 	4

	 	 	 	 	 	[...***...]	 	 	[...***...]	 	 	[...***...]	 
	 	5

	 	 	 	 	 	[...***...]	 	 	[...***...]	 	 	[...***...]	 
	 	6

	 	 	 	 	 	[...***...]	 	 	[...***...]	 	 	[...***...]	 
	 

*Confidential Treatment Requested

 

 

APPENDIX 1.4 NeuroBiotech Patents

1.

 

Review: Patents/Applications (NeuroBiotec GmbH)

[...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	File number

	 	 	Patent number
	 	 	Filing date
	 	 	Notes
	 	 	 Priority
	 	 	Status	 
	 	[...***...]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[...***...]	 
	 

[...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	File number

	 	 	Patent number
	 	 	Filing date
	 	 	Notes
	 	 	 Priority
	 	 	 Status	 
	 	[...***...]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[...***...]	 
	 

	* Confidential Treatment Requested

 1.

 

[...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	File number

	 	 	Patent number
	 	 	Filing date
	 	 	Notes
	 	 	 Priority
	 	 	Status	 
	 	[...***...]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[...***...]	 
	 

[...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	File number

	 	 	Patent number
	 	 	Filing date
	 	 	Notes
	 	 	Priority
	 	 	Status	 
	 	[...***...]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[...***...]	 
	 

	* Confidential Treatment Requested

 

 

NeuroBiotec Patents

(ref. to 1.4 of proposed License Agreement between Prestwick und Neurobiotec)

September 8, 2003

[...***...]

[THE ORIGINAL AGREEMENT INCLUDES A COPY OF A SUBMITTED PATENT APPLICATION, WHICH HAS PUBLISHED
AS [...***...]

	* Confidential Treatment Requested

 

 

APPENDIX 1.5 Schering Existing Data

 

 

	 	 	 	 	 	 	 
	Lisuride Existing Data
	 	 	 	 
	 	 	 	 	 
	 	 	  [...***...]	 	 
	 	 	 	 	 

	 	 	 	 	 	 	 	 
	 	Schering Existing Data	 	 	 	 
	 
	 	 	 	[...***...]
	 	 
	 	 

	* Confidential Treatment Requested

 

 

APPENDIX 1.6 Schering Patents

 

 

Dr. Johannes Tack

NeuroBiotec GmbH, Berlin

08.September 2003

Existing Schering Patents

Synopsis of Patent Numbers

	Schering Internal Number	 	PCT Number	 	US Application(Patent) Number	 	 	 	 
	(Appendix 1 of TTA)	 	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 
	 
	[...***
...]
	 	 	 	[...***
...]	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 
	 	 

	 	 
	 	 
	 

	* Confidential Treatment Requested

 

 

Status of TTS Patents

	A)  	Medium for transdermal application of Ergolin Derivatives
	 
	   	Internal Number                                                       [...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Internal	 	 	 	 	 	 	 	 	Application	 	 	Application	 	 	 	 	 	Grant	 	 	 	 
	 	Number Land	 	 	 	 	 	 	 	 	Date	 	 	Number	 	 	Grant Date	 	 	Number	 	 	Expiry Date	 
	 	[...***...]

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	[...***...]	 
	 

	B)  	Transdermal therapy System
	 
	   	Internal
Number                                                       [...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Internal	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Number	 	 	 	 	 	 	 	 	Application	 	 	Application	 	 	 	 	 	Grant	 	 	Expiry	 
	 	Land	 	 	 	 	 	 	 	 	Date	 	 	Number	 	 	Grant Date	 	 	Number	 	 	Date	 
	 	[...***...]

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	[...***...]	 
	 

	C)  	Treatment plan for transdermal as well as oral and/or parenteral delivery of Ergolin derivatives
	 
	   	Internal Number                                                       [...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Internal	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Number	 	 	 	 	 	 	 	 	Application	 	 	Application	 	 	 	 	 	Grant	 	 	Expiry	 
	 	Land	 	 	 	 	 	 	 	 	Date	 	 	Number	 	 	Grant Date	 	 	Number	 	 	Date	 
	 	[...***...]

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	[...***...]	 
	 

	* Confidential Treatment Requested

2.

 

	D)  	Lisuride Night-Patch
	 
	   	Internal Number                                                       [...***...]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Internal	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Number	 	 	 	 	 	 	 	 	Application	 	 	Application	 	 	 	 	 	Grant	 	 	Expiry	 
	 	Land	 	 	 	 	 	 	 	 	Date	 	 	Number	 	 	Grant Date	 	 	Number	 	 	Date	 
	 	[...***...]

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 

	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	[...***]
	 
	 

	* Confidential Treatment Requested

3.

 

APPENDIX 1.7 Third Party Bulk Drug Substance Agreement

 

 

[...***...]

	   	[...***...]

ARTICLE 1

[...***...]

	1.1  	[...***...]
	 
	1.1.1  	[...***...]
	 
	1.1.2  	[...***...]
	 
	1.1.3  	[...***...]
	 
	1.1.4  	[...***...]
	 
	1.1.5  	[...***...]
	 
	1.1.6  	[...***...]
	 
	1.1.7  	[...***...]

	 	(i)  	[...***...]
	 
	 	(ii)  	[...***...]
	 
	 	(iii)  	[...***...]
	 
	 	(iv)  	[...***...]
	 
	 	(v)  	[...***...]
	 
	 	(vi)  	[...***...]

	 
	 	(vii)  	 [...***...]

	1.1.8  	[...***...]
	 
	1.1.9  	[...***...]
	 
	1.2  	[...***...]

	* Confidential Treatment Requested

 

 

ARTICLE 2

[...***...]

	2.1  	[...***...]
	 
	2.2  	[...***...]

ARTICLE 3

[...***...]

[...***...]

[...***...]                    

                    [...***...]

[...***...]

ARTICLE 4

[...***...]

	4.1  	[...***...]
	 
	4.2  	[...***...]
	 
	4.3  	[...***...]

ARTICLE 5

[...***...]

	5.1  	[...***...]

	* Confidential Treatment Requested

2.

 

	5.2  	[...***...]
	 
	5.3  	[...***...]
	 
	5.4  	[...***...]

ARTICLE 6

[...***...]

[...***...]

ARTICLE 7

[...***...]

	7.1  	[...***...]
	 
	7.2  	[...***...]
	 
	7.3  	[...***...]
	 
	7.4  	[...***...]
	 
	7.5  	[...***...]

	 	(i)  	[...***...]
	 
	 	(ii)  	[...***...]
	 
	 	(iii)  	[...***...]

	7.6  	[...***...]
	 
	7.7  	[...***...]
	 
	7.8  	[...***...]
	 
	7.9  	[...***...]
	 
	7.10  	[...***...]
	 
	7.11  	[...***...]
	 
	7.12  	[...***...]

	* Confidential Treatment Requested

3.

 

	7.13  	[...***...]
	 
	7.14  	[...***...]
	 
	7.15  	[...***...]
	 
	7.16  	[...***...]
	 
	7.17  	[...***...]
	 
	7.18  	[...***...]

ARTICLE 8

[...***...]

	8.1  	[...***...]
	 
	8.2  	[...***...]
	 
	8.3  	[...***...]

	 	(i)  	[...***...]
	 
	 	(ii)  	[...***...]
	 
	 	(iii)  	[...***...]
	 
	 	(iv)  	[...***...]

	8.4  	[...***...]

ARTICLE 9

[...***...]

	9.1  	[...***...]
	 
	9.2  	[...***...]
	 
	9.3  	[...***...]
	 
	9.4  	[...***...]
	 
	9.5  	[...***...]

	* Confidential Treatment Requested

4.

 

ARTICLE 10

	 	(i)  	[...***...]
	 
	 	(ii)  	[...***...]

ARTICLE 11

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

ARTICLE 12

[...***...]

[...***...]

ARTICLE 13

[...***...]

[...***...]

	 	(i)  	[...***...]
	 
	 	(ii)  	[...***...]
	 
	 	(iii)  	[...***...]
	 
	 	(iv)  	[...***...]
	 
	 	(v)  	[...***...]

[...***...]

	* Confidential Treatment Requested

5.

 

ARTICLE 14

[...***...]

[...***...]

ARTICLE 15

[...***...]

[...***...]

ARTICLE 16

[...***...]

[...***...]

[...***...]

ARTICLE 17

[...***...]

[...***...]

ARTICLE 18

[...***...]

[...***...]

ARTICLE 19

[...***...]

	19.1  	[...***...]
	 
	19.2  	[...***...]
	 
	19.3  	[...***...]
	 
	19.4  	[...***...]

	* Confidential Treatment Requested

6.

 

ARTICLE 20

[...***...]

[...***...]

7.

 

APPENDIX 1.8 Third Party Formulation Agreement

 

 

[...***...]

	*Confidential Treatment Requested

1.

 

 

APPENDIX 1.9 TTA and Amendments thereto

1.

 

 

[...***...]

ARTICLE 1

[...***...]

ARTICLE 2

2.1 [...***...]

2.2 [...***...]

2.3 [...***...]

2.4 [...***...]

2.5 [...***...]

ARTICLE 3

[...***...]

3.1 [...***...]

3.2 [...***...]

3.3 [...***...]

ARTICLE 4

[...***...]

[...***...]

ARTICLE 5

[...***...]

5.1 [...***...]

5.2 [...***...]

5.3 [...***...]

	* Confidential Treatment Requested

1.

 

 

5.4 [...***...]

5.5 [...***...]

5.6 [...***...]

5.7 [...***...]

ARTICLE 6

[...***...]

6.1 [...***...]

6.2 [...***...]

6.3 [...***...]

ARTICLE 7

7.1 [...***...]

(i) [...***...]

(ii) [...***...]

7.2 [...***...]

7.3 [...***...]

7.4 [...***...]

ARTICLE 8

[...***...]

8.1 [...***...]

8.2 [...***...]

	* Confidential Treatment Requested

2.

 

 

ARTICLE 9

[...***...]

9.1 [...***...]

9.2 [...***...]

9.3 [...***...]

ARTICLE 10

[...***...]

10.1 [...***...]

10.2 [...***...]

10.3 [...***...]

10.3.1 [...***...]

10.3.2 [...***...]

10.4 [...***...]

10.5 [...***...]

10.6 [...***...]

ARTICLE 11

[...***...]

11.1 [...***...]

       (i) [...***...]

       (ii) [...***...]

11.2 [...***...]

ARTICLE 12

[...***...]

	* Confidential Treatment Requested

3.

 

 

ARTICLE 13

[...***...]

ARTICLE 14

[...***...]

14.1 [...***...]

14.2 [...***...]

14.3 [...***...]

14.4 [...***...]

ARTICLE 15

[...***...]

15.1 [...***...]

15.2 [...***...]

15.3 [...***...]

15.4 [...***...]

ARTICLE 16

[...***...]

16.1 [...***...]

16.2 [...***...]

16.3 [...***...]

ARTICLE 17

[...***...]

17.1
[...***...]

17.2 [...***...]

	* Confidential Treatment Requested

4.

 

 

17.3 [...***...]

ARTICLE 18

[...***...]

18.1 [...***...]

18.2 [...***...]

ARTICLE 19

[...***...]

19.1 [...***...]

19.2 [...***...]

19.3 [...***...]

ARTICLE 20

[...***...]

20.1 [...***...]

20.2 [...***...]

20.3 [...***...]

20.4 [...***...]

20.5 [...***...]

	* Confidential Treatment Requested

5.

 

 

APPENDIX 3.3 Clinical Supply Terms

1.

 

 

APPENDIX 3.3: Clinical Supply Terms

 Transdermal Formulation 

					
	Formulated Product:
	 	[Lisuride] Skin Patch
	 	(finished and filled packages, with package inserts)

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	Number of	 	 	 	 	 	 	 	 	Total Number	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Patches per	 	 	 	Number of	 	 	 	of	 	 	 	Price Per	 	 	 	Total	 	 	 	Shipping	 	 
	 	 	 	 	Patient	 	 	 	Patients	 	 	 	Patches	 	 	 	Patch	 	 	 	Price	 	 	 	Terms	 	 
	 	Phase 1
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 2
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 3
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 4
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

Bulk Drug: [Lisuride]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	Total	 	 	 	Quantity of	 	 	 	Total	 	 	 	Price Per	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Number of	 	 	 	Drug	 	 	 	Quantity	 	 	 	Unit	 	 	 	Total	 	 	 	Shipping	 	 
	 	 	 	 	Patches	 	 	 	Per Patch	 	 	 	of Bulk Drug	 	 	 	of Bulk Drug(1)	 	 	 	Price	 	 	 	Terms	 	 
	 	Phase 1
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 2
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 3
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 4
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	Notes
	 
	(1)	 	Quantity discount should reflect bulk quantity being purchased for IV and SC Formulation.
	 
	(2)	 	All purchases hereunder will be subject to definitive purchase orders.

  1.

 

 

IV and SC Formulation

Formulated Product:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	Number of	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Doses per	 	 	 	Number of	 	 	 	Total Number	 	 	 	Price Per	 	 	 	Total	 	 	 	Shipping	 	 
	 	 	 	 	Patient	 	 	 	Patients	 	 	 	of Doses	 	 	 	Dose	 	 	 	Price	 	 	 	Terms	 	 
	 	Phase 1
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 2
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 3
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 4
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

Bulk Drug: [Lisuride]

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Price Per	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Total	 	 	 	Quantity of	 	 	 	Total	 	 	 	Unit	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Number of	 	 	 	Drug	 	 	 	Quantity	 	 	 	of Bulk	 	 	 	Total	 	 	 	Shipping	 	 
	 	 	 	 	Doses	 	 	 	per Dose	 	 	 	of Bulk Drug	 	 	 	Drug(1)	 	 	 	Price	 	 	 	Terms	 	 
	 	Phase 1
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 2
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 3
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Phase 4
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	Notes
	 
	(1)	 	Quantity discount should reflect bulk quantity being purchased for Transdermal Formulation.
	 
	(2)	 	All purchases hereunder will be subject to definitive purchase orders.

  2.exv10w13

 

			
	 
	 	***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4) and

230.406

Exhibit 10.13

LICENSE AGREEMENT

THIS AGREEMENT, effective as of June 2001, between DR. MAURICE W. GITTOS, residing at 16 rue Andre
Malraux, 67115 Plobsheim, France (“LICENSOR”) and PRESTWICK SCIENTIFIC CAPITAL, INC., a Delaware
corporation having offices at 1825 K Street, N.W., Washington, D.C. 20006 (“LICENSEE”).

RECITALS

WHEREAS, LICENSOR owns the right, title and interest in the patent and other intellectual property
rights to the Licensed Inventions (defined herein);

WHEREAS, LICENSOR desires to grant, and LICENSEE desires to be granted, a license to the Licensed
Inventions in order to commercially develop, manufacture, use, sell and import throughout the world
products that embody the Licensed Inventions;

NOW THEREFORE, in consideration of the premises, the receipt of good and valuable consideration the
sufficiency of which is hereby acknowledged, and the faithful performance of the covenants herein
contained, the parties hereto agree as follows:

1. DEFINITIONS

1.1 “Accounting Period” shall mean each six-month period ending June 30 and December 31 during the
term of this Agreement, except that the first such period shall commence on the Effective Date and
end December 31, 2001.

1.2 “Affiliate” with respect to each party shall mean any corporation or other legal entity
controlling, controlled by or under common control with such party. The term “control” means
possession, direct or indirect, of the powers to direct or cause the direction of the management
and policies of an entity, whether through the ownership of voting securities, by contract or
otherwise.

1.3 “Effective Date” shall mean the date first written above.

1.4 “FDA” shall mean the United States Food and Drug Administration and any successor thereto.

1.5 “First Commercial Sale” shall mean the first sale of any Licensed Product by LICENSEE, its
Affiliates or Sublicensees, but not including transfers or dispositions of Licensed Product for
charitable, promotional, pre-clinical, clinical, regulatory or governmental purposes for which
LICENSEE receives no payment.

1.6 “License” shall have the meaning ascribed to that term in Section 2.1(a).

1.

 

1.7 “Licensed
Compounds” shall mean the [...***...]  salt of AGN 2979, the chemical formula of which is set forth in Schedule 1.7
attached to this Agreement, and any and all articles, devices, compositions, methods or services,
the manufacture, use or sale of which (a) would infringe a Valid Claim of a Licensed Patent in the
absence of the License or (b) uses or employs Licensed Know-how.

1.8 “Licensed Field” shall mean the treatment and provision of health care to humans for the
treatment of sleep apnea, related indications and other neuropsychiatric indications.

1.9 “Licensed Inventions” shall mean the inventions claimed in the Licensed Patents.

1.10 “Licensed Know-how” shall include all research data, designs, formulas, process information,
clinical data and other information relating to the Licensed Compounds, the Licensed Inventions,
the Licensed Patents or the Licensed Products which is developed by, or in the possession or
control of, LICENSOR now or at any time during the term of this Agreement other than such
information that is independently developed by LICENSEE or its agents, as evidenced by written
records.

1.11 “Licensed Patents” shall mean (i) the patents and patent applications set forth in Schedule
1.11 attached to this Agreement, (ii) any additional United States patent applications in respect
of any Licensed Technology Improvements (herein defined), and (iii) any letters patent granted in
respect of such applications, including, without limitation, any utility patent applications based
thereon, any substitutions, divisions, continuations, continuations-in-part, reissues, renewals,
re-examinations, extensions, supplementary protection certificates and the like, as well as any
additional patent applications based thereon and any international equivalents thereof.

1.12 “Licensed Products” shall mean any and all products comprising or containing a Licensed
Compound as an ingredient therein or as a part thereof.

1.13 “Licensed Technology” shall mean the aggregate of the Licensed Compounds, the Licensed
Inventions, the Licensed Know-how and the Licensed Patents.

1.14 “Licensed Technology Improvements” shall have the meaning ascribed to that term in Section
2.2.

1.15 (a) “Net Sales Price” shall mean the Gross Sales Price as defined in clause (b) of this
definition received by LICENSEE or any of its Affiliates or Sublicensees (“Sellers”) for the sale
of any Licensed Product to a third party that is not an Affiliate or Sublicensee of LICENSEE
(“CUSTOMER”), less (to the extent appropriately documented) the following amounts actually paid out
by LICENSEE, its Affiliate or Sublicensee or credited against the amounts received by them from the
sale or distribution of Licensed Product:

	 	(i)  	trade, quantity and cash discounts and sales returns and
allowances, including (A) those granted on account of price adjustments,
billing errors,
rejected goods, damaged goods, returns and rebates, (B) administrative and
other fees and reimbursements and similar payments to wholesalers

	* Confidential Treatment Requested

2.

 

	 	   	and other
distributors, buying groups, pharmacy benefit management organizations,
health care insurance carriers and other institutions, (C) allowances,
rebates and fees paid to distributors and (D) chargebacks for unsold
Licensed Product, where in each case such amounts are agreed to in the
reasonable judgment of Sellers taking into consideration, among other
things, the usual and customary practices of the pharmaceutical distribution
market, the stage of the life cycle of the Licensed Product and the market
share objectives for the Licensed Product;
	 
	 	(ii)  	amounts for transportation, insurance, handling, storage or
shipping charges;
	 
	 	(iii)  	taxes, duties and other governmental charges levied on or
measured by the sale of Licensed Products, whether absorbed by a Seller or paid
by the purchaser so long as Seller’s price is reduced thereby, but not
franchise or income taxes of any kind whatsoever;
	 
	 	(iv)  	rebates and similar payments made with respect to sales paid
for by any governmental or regulatory authority such as, by way of illustration
and not in limitation of the parties’ rights hereunder, Federal or state
Medicaid, Medicare or similar state program or equivalent foreign governmental
program; and
	 
	 	(v)  	any other similar and customary deductions that are consistent
with United States generally accepted accounting principles, or in the case of
non-United States sales, other applicable accounting standards.

     (b) For any bona fide sale to a bona fide Customer by a Seller, the Gross Sales Price shall be
the gross invoice price of the Licensed Product.

     (c) For purposes of determining Net Sales Price, a “sale” shall not include transfers or
dispositions for charitable, promotional purposes, or for pre-clinical, clinical, regulatory or
governmental testing purposes for which a Seller receives no payment.

     (d) If a Seller sells any Licensed Product in a bona fide sale as a component of a combination
of active functional elements, the Gross Sales Price of the Licensed Product shall be determined by
multiplying the Gross Sales Price of the combination by the fraction A over A + B, in which “A” is
the Gross Sales Price of the Licensed Product portion of the combination when sold separately
during the Accounting Period in the country in which the sale of such combination product was made,
and “B” is the Gross Sales Price of the other active elements of the combination sold separately
during said Accounting Period in said country. In the event that no separate sale of either such
Licensed Product or active elements of the combination is made during said Accounting Period in
said country, the Gross Sales Price of the Licensed Product shall be determined by multiplying the
Gross Sales Price of such combination by the fraction C over C + D, in which “C” is the standard
fully-absorbed cost of the Licensed Product portion of
such combination, and “D” is the sum of the standard fully-absorbed costs of the other active
elements component(s), such costs being arrived at using the standard accounting procedures of

3.

 

such Seller which will be in accord with generally accepted accounting practices.

     (e) If a Seller commercially uses or disposes of any Licensed Product by itself (as opposed to
a use or disposition of the Licensed Product as a component of a combination of active functional
elements) other than in a bona fide sale to a bona fide Customer, the Gross Sales Price hereunder
shall be the price which would be then payable in an arm’s length transaction with such a Customer.
If a Seller commercially uses or disposes of any Licensed Product as a component of a combination
of active functional elements other than in a bona fide sale to a bona fide customer, the Gross
Sales Price of the’ Licensed Product shall be determined in accordance with clause (d) above, using
as the Gross Sales Price of the combination that price which would be then payable in an arm’s
length transaction.

     (f) Transfer of a Licensed Product within a Seller or between or among LICENSEE and its
Affiliate and Sublicensees for sale by the transferee shall not be considered a sale, commercial
use or disposition for the purpose of the foregoing subsections; in the case of such transfer the
Gross Sales Price shall be the Gross Sales Price of the Licensed Product when sold to a third party
by the transferee.

1.16 “Patent Right” shall mean any right, title or interest in any Licensed Patent.

1.17 “Phase II Clinical Trial” shall mean a clinical trial of a pharmaceutical product having a
design that, under usual and customary standards in the life sciences industry, would be commonly
referred to as a “Phase II” or “dosing” clinical trial to be conducted for the purposes of
determining an effective dosage of such pharmaceutical product for further clinical trials in a
population of patients sufficiently large in order to assess the safety, efficacy, benefits and
risks, and range and severity of possible adverse side effects of the pharmaceutical product for
purposes of obtaining regulatory approval to market such pharmaceutical product and establishing
the proposed labeling of the pharmaceutical or therapeutic treatment.

1.18 “Sublicensee” shall mean any third party licensed by LICENSEE or by an Affiliate thereof to
make or have made, use or have used, sell or have sold, import or have imported any Licensed
Product.

1.19 “Valid Claim” shall mean any pending or issued claim of any patent application or patent that
has not been finally rejected or declared invalid or unenforceable by a patent office or court of
competent jurisdiction in any unappealed and unappealable decision.

2. LICENSE

2.1 Grant of License. Subject to the provisions of this Agreement, LICENSOR hereby grants
LICENSEE,

     (a) a royalty-bearing, irrevocable, worldwide license (the “License”) in the Licensed Field
under the Patent Rights to the Licensed Technology to make and have made, use and have used, sell
and have sold, import and have imported Licensed Products, which license shall be exclusive even as
to LICENSOR, and

     (b) the right to grant bona fide sublicenses to third parties, to make and have made,

4.

 

use and
have used, sell and have sold, import and have imported Licensed Products; provided, however,
LICENSEE shall not have the right to grant any sublicense or to transfer any of its rights under
the License unless each such sublicense or other transfer granted by LICENSEE contains terms and
conditions under which the Sublicensee or transferee will be bound in the same manner as LICENSEE
is under this Agreement.

2.2 Improvements. The parties acknowledge and agree that this Agreement shall apply to any
and all improvements, modifications, enhancements, or other changes to the Licensed Technology
created, conceived, developed, or reduced to practice by LICENSOR during the term of this Agreement
(collectively, the “Licensed Technology Improvements”). Licensed Technology Improvements shall be
considered to be a part of the Licensed Technology and shall be licensed to LICENSEE in accordance
with the provisions of this Agreement.

2.3 Disclosure. Within one (1) month after the Effective Date, LICENSOR shall disclose to
LICENSEE the Licensed Know-How.

2.4 Data License. In the event that LICENSEE determines not to commercialize any Licensed
Product in any jurisdiction or the License granted under Section 2.1 terminates with respect to any
jurisdiction, LICENSEE agrees to grant to LICENSOR;

     (a) a royalty-bearing, irrevocable, worldwide license (the “Data License”) in the Licensed
Field under LICENSEE’s then existing intellectual property rights in and to the information and
data resulting from clinical trials of Licensed Products undertaken by or on behalf of LICENSEE
prior to such determination or termination in order for LICENSOR to make and have made, use and
have used, sell and have sold, import and have imported Licensed Products, and

     (b) the right to grant bona fide sublicenses of the Data License to third parties, to make and
have made, use and have used, sell and have sold, import and have imported Licensed Products;
provided, however, LICENSOR shall not have the right to grant any sublicense or to transfer any of
its rights under the License unless, except as otherwise provided in this Agreement, each such
sublicense or other transfer granted by LICENSOR contains terms and conditions under which the
sublicensee or transferee will be bound in the same. manner as LICENSOR is under this Agreement
with respect to the Data License.

3. DEVELOPMENT OBLIGATIONS

3.1 LICENSEE’s Obligations. LICENSEE shall use its commercially reasonable efforts to
develop and commercialize one or more Licensed Products.

3.2 Progress Reports. At intervals no longer than every twelve (12) months, LICENSEE shall
report in writing to LICENSOR on progress made toward achieving the development and
commercialization of one or more Licensed Products.

3.3 Cooperation of Licensor. LICENSOR shall provide to LICENSEE such assistance,
consultation and cooperation as shall be reasonably requested by LICENSEE relating to the
development and commercialization of Licensed Products.

5.

 

4. FILING, PROSECUTION AND MAINTENANCE OF LICENSED PATENTS

4.1
Responsibility. Following the Effective Date, LICENSEE,
[...***...]
shall be responsible for the preparation, filing, prosecution
and maintenance of all patent applications and patents included in the Licensed Patents; provided,
however, that if the License terminates with respect to all jurisdictions in accordance with
Article 9 of this Agreement or LICENSEE determines to cease the preparation, filing, prosecution or
maintenance of any patent application or patent included in the Licensed Patents, then LICENSOR, at
its option [...***...] shall have the right, [...***...] to assume responsibility for such
preparation, filing, prosecution and maintenance.

4.2 Delivery of Existing Documents. With respect to each Licensed Patent, each document or
a draft thereof pertaining to the filing, prosecution, or maintenance of such Licensed Patent,
including, without limitation, each patent application, office action, response to office action,
request for terminal disclaimer, request for reissue or reexamination of any patent issuing from
such application, and all other prosecution items contained in the file maintained by or for
LICENSOR in respect of such Licensed Patent in the possession of LICENSOR or its counsel at the
Effective Date shall be provided to LICENSEE within thirty (30) days of the Effective Date and any
such documents received by LICENSOR or its counsel from any patent office after the Effective Date
shall be provided promptly after receipt.

5. ROYALTIES AND MILESTONE PAYMENTS

5.1 Royalties. Beginning with the First Commercial Sale in any country of any Licensed
Product by LICENSEE or any of its Affiliates or Sublicensees, LICENSEE shall pay to LICENSOR
royalties in accordance with the following schedule for each Licensed Product sold by LICENSEE or
its Affiliates and Sublicensees so long as the manufacture, use, sale, import or offer for sale of
such Licensed Product would, in the country where such manufacture, use, sale, import or offer for
sale of such Licensed Product occurs, infringe a Valid Claim of any Licensed Patent or violate an
exclusive marketing right granted by any governmental agency in such country in the absence of the
License granted by Article 2 or a sublicense granted under Article 2:

	 	(i)  	[...***...] ([...***...]%) of the Net Sales Price received by LICENSEE
or any Affiliate of LICENSEE from the sale of such Licensed Product by LICENSEE
or such Affiliate;
	 
	 	(ii)  	[...***...] percent ([...***...]%) of the revenue received by LICENSEE
or any Affiliate of LICENSEE received from any other person or organization in
the form of royalties, milestone payments or any other payment of any kind in
respect of sublicenses granted by LICENSEE or any of its Affiliates under
Article 2 or related agreements after deducting from the amount of such
royalties [...***...] and relating to the [...***...];

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6.

 

Only one royalty under this Section 5.1 shall be due and payable to LICENSOR by LICENSEE in respect
of the sale of any Licensed Product regardless of the number of Valid Claims covering such Licensed
Product.

5.2 Milestone Payments. In addition to the payments provided for in Section 5.1, LICENSEE
shall pay LICENSOR the following amounts upon the occurrence of the following events:

     (a) Completion of the first Phase II Clinical Trial of a Licensed Product: [...***...].

     (b) Acceptance by the FDA of a filing of a New Drug Application for commercial sale of a
Licensed Product: [...***...].

5.3 Credits for Payments to Third Parties.

     (a) In the event that LICENSEE is required to pay royalties to any third parties with respect
to the development or commercialization of a Licensed Product, LICENSEE will have the right to
offset such royalties against any payments owed to LICENSOR pursuant to Section 5.1, provided that
no such offset shall result in a reduction of the royalties owed to LICENSOR pursuant to Section
5.1 to an amount [...***...] 

     (b) For any Licensed Product sold by any Sublicensee, where the sum of royalty payments owed
by such Sublicensee to LICENSEE or any of LICENSEE’s Affiliates and any third parties [...***...], the
royalty rate payable to LICENSOR shall be [...***...], provided that the [...***...] and that in no event
shall [...***...].

     (c) Notwithstanding Sections 5.3(a) and 5.3(b), in the event that the royalty payable to
LICENSOR in respect of the sale of any Licensed Product in any country is [...***...], LICENSOR agrees
[...***...] will include [...***...] on Licensed Product and [...***...],[...***...] of [...***...] products, total
[...***...] by LICENSEE, and LICENSEE’s [...***...] in Licensed Product [...***...].

5.4 Overdue Payments. The payments due under this Agreement shall, if overdue, bear
interest until payment at a per annum rate equal to the [...***...] on the due date, not to exceed the
maximum permitted by law. The payment of such interest shall not preclude LICENSOR from exercising
any other rights it may have as a consequence of the lateness of any payment.

5.5 Currency. All royalty payments and milestone payments under this Agreement shall be in
United States Dollars. Whenever conversion from any foreign currency shall be required, such
conversion shall be at the rate of exchange thereafter published in the Wall Street Journal for the
business day closest to the end of the applicable Accounting Period.

5.6 Data License Royalties. Beginning with the First Commercial Sale in any country of any
Licensed Product by LICENSOR or any of its Affiliates or sublicensees under the Data License,
LICENSOR shall pay to LICENSEE royalties equal to [...***...] ([...***...]%) of the Net Sales Price
received by LICENSOR or any Affiliate of LICENSOR from the sale of such Licensed Product by
LICENSOR or such Affiliate and of the revenue received by LICENSOR or any

	* Confidential Treatment Requested

7.

 

Affiliate of LICENSOR received from any other person or organization in the form of royalties,
milestone payments or any other payment of any kind in respect of sublicenses granted by LICENSOR
or any of its Affiliates under the Data License or related agreements after deducting from the
amount of such royalties [...***...] 
and
relating to the [...***...]. The payment and reporting terms for any payments due from LICENSOR to
LICENSEE under the first sentence of this Section 5.6 shall be correlatively identical to the
payment terms set forth in this Agreement for payments of royalties by LICENSEE to LICENSOR in
respect of the License.

6. REPORTS AND PAYMENTS

6.1 Books of Accounts. LICENSEE shall keep, and shall cause each of its Affiliate and
Sublicensees, if any, to keep full and accurate books of accounts containing all particulars that
may be necessary for the purpose of calculating all royalties payable to LICENSOR. Such books of
account shall be kept at their principal place of business and, with all necessary supporting data
shall, during all reasonable times for the three (3) years next following the end of the calendar
year to which each shall pertain, be open for inspection at reasonable times by LICENSOR or its
designee at LICENSOR’s expense for the purpose of verifying royalty statements or compliance with
this Agreement. In the event that any audit performed under this Section 6.1 reveals an
underpayment in excess of ten percent (10%) of the total amount determined by the auditor to be due
LICENSOR, LICENSEE shall bear the full cost of such audit and shall remit any amounts due to
LICENSOR within ninety (90) days of receiving notice thereof from LICENSOR.

6.2 Semiannual Payments. In each year the amount of royalty due shall be calculated
semiannually on a cash received basis as of the end of each Accounting Period and shall be paid
semiannually within the sixty (60) days next following such date, every such payment to be
supported by the accounting prescribed in Section 6.3.

6.3 Accounting Reports. With each semiannual payment, LICENSEE shall deliver to LICENSOR a
full and accurate accounting to include at least the following information:

     (a) Quantity of each Licensed Product sold by LICENSEE and its Affiliates or Sublicensees (by
country).

     (b) Gross Sales Price billed and Net Sales Price received by LICENSEE or any of its Affiliates
or Sublicensees (“Sellers”) for the sale of each Licensed Product (by country);

     (c) Quantities of each Licensed Product used by LICENSEE and its Affiliate or Sublicensees;

     (d) Names and addresses of all Sublicensees of LICENSEE; and

     (e) Total royalties payable to LICENSOR.

	* Confidential Treatment Requested

8.

 

7. INFRINGEMENT

7.1 Infringement of Licensed Patents. Each party shall promptly notify the other party of
evidence of infringement of a claim of a Licensed Patent by a third party. If either party shall
have supplied the other party with written evidence demonstrating prima facie infringement of a
claim of an Licensed Patent in the Licensed Field by a third party, LICENSEE shall have the right
to take steps to protect the Patent Right in such claim, either upon notice from LICENSOR
requesting such action, or on its own initiative. LICENSEE shall notify LICENSOR within
[...***...]  of one party’s providing the other
with evidence of infringement whether LICENSEE intends to prosecute the alleged infringement. If
LICENSEE notifies LICENSOR that it intends to so prosecute, LICENSEE shall, within [...***...] of its
notice to LICENSOR either (i) cause infringement to terminate or (ii) initiate and diligently
prosecute legal proceedings against the infringer and in LICENSOR’s name if so required by law. In
the event LICENSEE notifies LICENSOR That LICENSEE does not intend to prosecute said infringement,
LICENSOR may, upon notice to LICENSEE, initiate legal proceedings against the infringer at
LICENSOR’s expense. No settlement, consent judgment or other voluntary final disposition of the
suit which invalidates or restricts the claims of such Patent Rights may be entered into without
the consent of the other party, which consent shall not be unreasonably withheld, but provided
that, in the event one party (“the Objecting Party”) withholds consent for a proposed settlement,
the party proposing the settlement may [...***...] of such suit or settlement discussions, and the
Objecting Party shall be required to continue such suit or settlement discussions [...***...]. LICENSEE
shall. indemnify LICENSOR against any order for payment that may be made against LICENSOR in such
proceedings brought by LICENSEE. LICENSOR shall indemnify LICENSEE against any damages that may be
made against LICENSEE to the extent arising out of any proceedings which LICENSOR brings [...***...]
pursuant to this Section 7.1 following LICENSEE’s decision not to prosecute any alleged
infringement.

7.2 Cooperation. In the event one party shall initiate or carry on legal proceedings to
enforce any Patent Right against any alleged infringer, the other party shall fully cooperate with
and supply all assistance reasonably requested by the party initiating or carrying on such
proceedings. The party which institutes any suit to protect or enforce a Patent Right shall have
sole control of that suit and shall [...***...] in providing such assistance and cooperation as is
requested pursuant to this Section. The party initiating or carrying on such legal proceedings
shall keep the other party informed of the progress of such proceedings and said other party shall
be entitled to counsel in such proceedings [...***...]. Any award paid by third parties as the result
of such proceedings (whether by way of settlement or otherwise) shall first be applied to
reimbursement of the unreimbursed legal fees and expenses incurred by either party and then the
remainder shall be divided between the parties as follows:

     (a) If the amount is based on lost profits, LICENSEE shall receive an amount equal to the
damages the court determines LICENSEE has suffered as a result of the infringement less the amount
of any royalties that would have been due LICENSOR on sales of Licensed Product lost by LICENSEE as
a result of the infringement had LICENSEE made such sales, and LICENSOR shall receive an amount
equal to the royalties it would have received if such sales had been made by LICENSEE, and

	* Confidential Treatment Requested

9.

 

     (b) As to awards other than those based on lost profits, [...***...] ([...***...]%) to [...***...] and
[...***...] ([...***...]%) to [...***...].

7.3 Infringement Actions by Third Parties. In the event that the making, selling or using
of a Licensed Product in the Licensed Field infringes the intellectual property rights of others,
LICENSEE will have the first right to control any negotiation or litigation with respect thereto.

7.4 Further Assurances; Progress Reports. For the purpose of the proceedings referred to in
this Article 7, LICENSOR and LICENSEE shall permit the use of their names and shall execute such
documents and carry out such other acts as may be necessary. The party initiating or carrying on
such legal proceedings shall keep the other party informed of the progress of such proceedings and
said other party shall be entitled to counsel in such proceedings but [...***...], said
[...***...]  by the party bringing any
infringement suit against a third party in accordance with Section 7.3.

8. INDEMNIFICATION; REPRESENTATIONS AND WARRANTIES

8.1 Indemnification.

     (a) LICENSEE shall indemnify, defend and hold harmless LICENSOR and its directors, officers,
medical and professional staff, employees, and agents and their respective successors, heirs and
assigns (each an “Indemnitee” under this Section 8.1(a)), against any liability, damage, loss or
expense (including reasonable attorney’s fees and expenses of litigation) (collectively, “Losses”)
incurred by or imposed upon such Indemnitees or any one of them in connection with any claims,
suits, actions, demands or judgments arising out of any theory of product liability (including, but
not limited to, actions in the form of tort, warranty, or strict liability) concerning any Licensed
Product made, used or sold pursuant to any right or license granted under this Agreement other than
Losses arising out of claims of infringement of intellectual property rights held by third parties
by the practice of the Licensed Inventions.

     (b) LICENSOR shall indemnify, defend and hold harmless LICENSEE and its directors, officers,
medical and professional staff, employees, and agents and their respective successors, heirs and
assigns (each an “Indemnitee” under this Section 8.1(b)), against any Losses incurred by or imposed
upon such Indemnitees or any one of them in connection with any claims, suits, actions, demands or
judgments arising out of (i) any theory of product liability (including, but not limited to,
actions in the form of tort, warranty, or strict liability) concerning any Licensed Product made,
used or sold by LICENSEE or any of its Affiliates or Sublicensees pursuant to any right or license
granted under this Agreement, but only to the extent that any such claim, suit, action, demand or
judgment owes to a failure on the part of LICENSOR to advise LICENSEE as to some unsafe element of
the Licensed Technology that LICENSOR knew or should have known, (ii) any theory of product

liability (including, but not limited to, actions in the form of tort, warranty, or strict
liability) concerning any Licensed Product made, used or sold by LICENSOR or any of its Affiliates
or sublicensees pursuant to the Data License and (iii) any claims of infringement of intellectual
property rights held by third parties by the practice of the Licensed Inventions.

	* Confidential Treatment Requested

10.

 

     (c) No Indemnitee under clause (a) or clause (b) of this Section 8.1 shall be entitled to any
indemnification under such clause for any Loss to the extent that such Loss is attributable to the
negligent activities, reckless misconduct or intentional misconduct of such Indernnitee.

     (d) Any Indemnitee under clause (a) or clause (b) of this Section 8.1 shall give the party
from whom indemnification under such clause is sought (the “Indemnitor”) prompt written notice of
any Losses or discovery of fact upon which such Indemnitee intends to base a request for
indemnification under such clause, provided, however, that an Indemnitor’s obligations to such
Indemnitee under this Section 8.1 shall not be .rendered inapplicable as a result of the failure by
such Indemnitee to notify such Indemnitor as required under this Section 8.1(d), unless such
failure materially prejudices such Indemnitor’s ability to take action with respect to any such
Loss.

     (e) Each Indemnitor under this Section 8.1 agrees, at its own expense, to provide attorneys
reasonably acceptable to an Indemnitee under this Section 8.1 to defend against any actions brought
or filed against such Indemnitee with respect to the subject of indemnity contained herein, whether
or not such actions are rightfully brought. Each Indemnitee under this Section 8.1 shall be
entitled to participate in, but not control, the defense of such action and to employ counsel of
its own choice for such purpose; provided, however, that such employment shall be at such
Indemnitee’s own expense.

     (f) Each Indemnitor shall have the sole right to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of any Loss, on such terms as such Indemnitor, in its sole
discretion, shall deem appropriate.

8.2 Representations and Warranties. LICENSOR represents to LICENSEE that:

     (a) There is no fact or circumstance that could adversely affect the acceptance, or the
subsequent approval, by any regulatory authority of any filing, application or request (including
pricing and reimbursement approval) with respect to the development or commercialization of any
Licensed Product existing on the Effective Date.

     (b) LICENSOR is the sole and exclusive owner of all right, title and interest in and to the
Patent Rights to the Licensed Patents and such rights are not subject to any encumbrance, lien or
claim of ownership by any third party. LICENSOR has obtained all necessary assignments and made all
appropriate filings with respect thereto in order to secure its sole and exclusive ownership rights
in and to such Patent Rights. During the term of this Agreement, LICENSOR shall not knowingly take
any action that would encumber the rights granted to LICENSEE hereunder.

     (c) Except for the grant by LICENSOR to LICENSEE of the License and other rights in Article 2,
LICENSOR has not, directly or indirectly, expressly or by implication, by action or omission or
otherwise (i) assigned, transferred, or conveyed any right, title or interest in or to the Patent
Rights in the Licensed Patents, (ii) granted any license or other right, title or interest in or to
the Patent Rights in the Licensed Patents, or (iii) agreed to or is otherwise bound by any covenant
not to sue for any infringement, misuse or otherwise with respect to the Patent Rights in the
Licensed Patents.

11.

 

     (d) There is no actual or threatened infringement by a third party of the Patent Rights in the
Licensed Patents.

8.3 Disclaimer. OTHER THAN WARRANTIES SET FORTH HEREIN, LICENSOR MAKES NO WARRANTY, EXPRESS
OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY IMPLIED
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK, SOFTWARE, TRADE
SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR DATA LICENSED OR OTHERWISE PROVIDED TO LICENSEE
HEREUNDER AND HEREBY DISCLAIMS THE SAME.

9. TERMINATION

9.1 Upon Expiration of Patent Rights and Exclusive Marketing Rights. Unless otherwise
terminated as provided for in this Agreement, the License and other rights granted to LICENSEE in
Article 2 will continue on a country by country basis and shall expire in each country upon the
last to expire in such country of any Licensed Patent granted under the laws of that country or the
expiration of any exclusive marketing rights for any Licensed Compound or Licensed Product in such
country. Upon such expiration of such last to expire Licensed Patent or such exclusive marketing
rights, LICENSEE will have a fully-paid-up, royalty-free license with respect to such Licensed
Patent and such Licensed Compound or Licensed Product in such country. In the event LICENSOR and/or
LICENSEE are unable to obtain patent protection or exclusive marketing rights for any Licensed
Compound or Licensed Product in any country, the License shall be in effect with respect to such
Licensed Compound or Licensed Product in such country [...***...] 
and subject to the conditions specified in Section 5.1 for a
period of ten
(10) years after the Effective Date.

9.2 Upon Default, Generally. If either party shall fail to faithfully perform any of its
obligations under this Agreement, the nondefaulting party may give written notice of the default to
the defaulting party. Unless such default is corrected within [...***...] after such notice, the
notifying party may terminate this Agreement upon [...***...] prior written notice; provided, however,
in the event that prior to the expiration of any such [...***...] period, such breaching party has in
good faith commenced to use commercially reasonable efforts to remedy such breach and the
completion of such remedy, due to reasons beyond the control of such breaching party, requires more
than [...***...] to complete, then such [...***...] period shall be extended for so long as such breaching
party is continuing in good faith to use commercially reasonable efforts to remedy such breach.

9.3 Effect on Sublicenses. In the event that the License granted to LICENSEE under this
Agreement is terminated, any sublicense under such License granted prior to termination of said
License shall remain in full force and effect, provided that

     (a) the Sublicensee is not then in breach of its sublicense agreement;

     (b) the Sublicensee agrees to be bound to LICENSOR as the licensor under the terms and
conditions of this Agreement, as modified by the provisions of this Section 9.3;

	* Confidential Treatment Requested

12.

 

     (c) LICENSOR shall have the right to receive any payments payable to LICENSEE under such
sublicense agreement to the extent they are reasonably and equitably attributable to such
Sublicensee’s right under such sublicense to use and exploit Patent Rights in the Licensed Patents;

     (d) the Sublicensee agrees to be bound by the development and commercialization obligations of
LICENSEE pursuant to Article 3 (whether set by the parties or by arbitration) in the field and
territory of the sublicense;

     (e) LICENSOR has the right to terminate such sublicense
 upon [...***...]  prior written notice to LICENSEE and such Sublicensee in the
event of any material breach of the obligation to make the payments described in clause (c) of this
Section 9.3, unless such breach is cured prior to the expiration of such [...***...] period, and shall
further have the right to terminate such sublicense in the event of Sublicensee’s failure to meet
its development obligations pursuant to clause (d) hereof; and

     (f) LICENSOR shall not assume, and shall not be responsible to such Sublicensee for, any
representations, warranties or obligations of LICENSEE to such Sublicensee, other than to permit
such Sublicensee to exercise any rights to Patent Rights in the Licensed Patents that are granted
under such sublicense agreement consistent with the terms of this Agreement.

9.4 Payments. Upon termination of the License granted hereunder, LICENSEE shall pay
LICENSOR all royalties due or accrued on (i) the sale of Licensed Products up to and including the
date of termination and (ii) for [...***...] following the date of termination, the sale of Licensed
Products manufactured prior to the termination date.

9.5 Expiration of Data License. Any Data License granted hereunder shall expire at such
time in any jurisdiction as the intellectual property rights in the information and data licensed
to LICENSOR under the Data License are no longer proprietary to LICENSEE in such jurisdiction,
except for the loss of such intellectual property rights due to the actions taken by LICENSOR,
LICENSOR’s Affiliates and LICENSOR’s sublicensees. The terms of Section 9.3 shall correlatively
apply to any sublicenses granted under the Data License.

9.6 Expiration of License. Upon termination of the License granted hereunder with respect
to all jurisdictions, LICENSOR shall have the option to purchase from LICENSEE any quantities of
Licensed Compound then owned by LICENSEE for a purchase price [...***...] with respect to such
quantities of Licensed Compound.

10. CONFIDENTIAL INFORMATION

10.1 Definitions. Each party receiving information (the “Receiving Party”) disclosed to it
by the other party (the “Disclosing Party”) acknowledges that by reason of its relationship to the
Disclosing Party hereunder, and pursuant to the provisions of that certain letter agreement, dated
February 20, 2001 (the “Letter Agreement”), between the parties, will have, or has had, access to
certain information and materials, including the terms of this Agreement, the information and
materials provided pursuant to the Letter Agreement, and information concerning the Disclosing

	* Confidential Treatment Requested

13.

 

Party’s business, plans, technology, products and/or services that are confidential and of
substantial value to the Disclosing Party (“Confidential Information”).

10.2 Obligation to Protect Confidential Information. Each Receiving Party agrees that it
shall (i) take every reasonable precaution to protect the confidentiality of Disclosing Party’s
Confidential Information from unauthorized access or use and (ii) not use the Disclosing Party’s
Confidential Information in any way for the Receiving Party’s own account or the account of any
third party except for the purposes of performing its obligations under this Agreement. Upon
termination of this Agreement and the request of the Disclosing Party, the Receiving Party will
return to the Disclosing Party all of the Disclosing Party’s Confidential Information in its
possession or within its control or destroy such Confidential Information and certify in writing to
the Disclosing Party that all such information has been destroyed.

10.3 Exclusions. Confidential Information does not include any information that the
Receiving Party can demonstrate by written records: (a) was known to the Receiving Party prior to
its disclosure by the Disclosing Party; (b) was independently developed by the Receiving Party
without use of or reference to the Disclosing Party’s Confidential Information; (c) was or becomes
publicly known through no wrongful act of the Receiving Party; (d) was rightfully received from a
third party whom the Receiving Party had reasonable grounds to believe was authorized to make such
disclosure without restriction; and (d) has been approved for public release by the Disclosing
Party’s prior written authorization. Further, if the Receiving Party is requested or required to
disclose Confidential Information pursuant to a subpoena, court order or other similar process
(“Court Order”), it is agreed that the Receiving Party shall provide the Disclosing Party with
notice of such request(s) so that the Disclosing Party may seek an appropriate protective order. In
the event that the Disclosing Party is not successful in obtaining a protective order and the
Receiving Party is compelled to disclose the Confidential Information under pain of liability for
contempt of court or other censure or penalty, the Receiving Party may disclose such information
solely in accordance with and for the limited purpose of compliance with the Court Order without
liability hereunder.

10.4 Disclosures Required by Law. In addition, either party may disclose, on a confidential
basis, the existence and terms of this Agreement in connection with a potential acquisition of
substantially the entire business or assets of such party or a private or public offering of such
party’s securities solely as necessary to comply with applicable law. Furthermore, either party may
disclose, on a confidential and need-to-know basis, the existence and terms of this Agreement and
the proposed terms of this Agreement to its counsel, accountants, directors and other similar
advisors (the “Representatives”) and either party may use Residuals (as defined below) for any
purpose, including, without limitation, use in development, manufacture, promotion, sale and
maintenance of any products or services. The term
“Residuals” means [...***...] .
The foregoing shall not, however, operate to grant either
party any rights under any patents, trade secrets, copyrights, or any other proprietary rights of
the other party.

	* Confidential Treatment Requested

14.

 

11. MISCELLANEOUS

11.1 Entire Agreement. This Agreement constitutes the entire understanding between the
parties with respect to the subject matter hereof.

11.2 Notices. All notices and other communications required or permitted under this
Agreement shall be in writing and shall be sent by registered or certified mail (return receipt
requested and postage prepaid), transmitted by facsimile, or delivered by hand, by messenger or by
a recognized overnight delivery service, addressed to each party as follows:

          if to LICENSOR:

DR. MAURICE W. GITTOS

16 rue Andre Malraux

67115 Plobsheim, France

Telephone: 33-388985497

Facsimile: 33-388321980

          if to LICENSEE:

PRESTWICK SCIENTIFIC CAPITAL, INC.

1825 K Street, N.W., Suite 1475

Washington, D.C. 20006

Attention: Alana R. Davidson Telephone: 202-296-1400

Facsimile: 202-296-7450

Each such notice or other communication shall for all purposes of this Agreement be treated as
effective or having been given (i) if sent by registered or certified mail, the earlier of receipt
and five (5) business days after dispatch, (ii) if transmitted by facsimile, on the business day of
confirmed receipt by the addressee thereof, and (iii) if delivered in person or by overnight
courier, on the business day delivered.

11.3 Amendments; Waivers. This Agreement may be amended and any of its terms or conditions
may be waived only by a written instrument executed by the parties or, in the case of a waiver, by
the party waiving compliance. The failure of either party at any time or times to require
performance of any provision hereof shall in no manner affect its rights at a later time to enforce
the same. No waiver by either party of any condition shall be deemed as a further or continuing
waiver of such condition or term or of any other condition or term.

11.4 Assignment, Succcesors. This Agreement shall be binding upon and inure to the benefit
of and be enforceable by the parties hereto and their respective successors and permitted assigns;
provided that this Agreement shall not be assignable by LICENSOR without LICENSEE’s written consent
except for the right to receive royalties or other payments payable herein, and further provided
that LICENSEE may at its own discretion and without approval by LICENSOR transfer its interest or
any part thereof under this Agreement to a wholly-owned subsidiary of LICENSEE or any assignee or
purchaser of the portion of its business associated with the manufacture and sale of Licensed
Product, so long as such transferee assumes and agrees to be bound by the provisions of this
Agreement. Except as provided in the immediately preceding

15.

 

sentence, this Agreement shall be assignable by LICENSEE only with the consent in writing of
LICENSOR, not to be unreasonably withheld, provided that the proposed assignee has sufficient
resources and capabilities to operate a business in the Licensed Field.

11.5 Force Majeure. Any delays in or failures of performance by either party under this
Agreement shall not be considered a breach of this Agreement if and to the extent caused by
occurrences beyond the reasonable control of the party affected, including but not limited to: acts
of God, acts, regulations or laws of any government, strikes or their concerted acts of worker,
fires, floods, explosions, riots, wars, rebellion, and sabotage. Any time for performance hereunder
shall be extended by the actual time of delay caused by such occurrence; provided, however, that
either party shall have the right to terminate this Agreement if any such extension endures for
more than twelve (12) consecutive months.

11.6 Publicity. Neither party shall use the name of the other party or of any staff member,
officer, employee or student of the other party or any adaptation thereof in any advertising,
promotional or sales literature, publicity or in any document employed to obtain funds or financing
without the prior written approval of the party or individual whose name is to be used.

11.7 Governing Law. This Agreement shall be governed by and construed and interpreted in
accordance with the laws of the State of Delaware, without regard to its choice of law principles.

11.8 Alternative Dispute Resolution. For any and all claims, disputes, or controversies
arising under, out of, or in connection with this Agreement, except issues relating to the
validity, construction or effect of any Patent Right, which the parties shall be unable to resolve
within [...***...] , the party raising such
dispute shall promptly advise the other party of such claim, dispute, or controversy in a writing
which describes in reasonable detail the nature of such dispute. By not later than [...***...] after
the recipient has received such notice of dispute, each party shall have selected for itself a
representative who shall have the authority to bind such party and shall additionally have advised
the other party in writing of the name and title of such representative. By not later than [...***...]
after the date of such notice of dispute, such representatives shall agree upon a third party,
which is in the business of providing Alternative Dispute Resolution (ADR) services (hereinafter,
“ADR Provider”) and shall schedule a date with such ADR Provider to engage in ADR. Thereafter, the
representatives of the parties shall engage in good faith in an ADR process under the auspices of
the selected ADR Provider. If within the aforesaid [...***...] after the date of the notice of dispute
the representatives of the parties have not been able to agree upon an ADR Provider and schedule a
date to engage in ADR, or if they have not been able to resolve the dispute within [...***...] after
the conclusion of ADR, the parties shall have the right to pursue any other remedies legally
available to resolve such dispute in either the state or federal courts of Delaware, to whose
jurisdiction for such purposes each of LICENSOR and LICENSEE hereby irrevocably consents and
submits. Notwithstanding the foregoing, nothing in this Section 11.8 shall be construed to waive
any rights or timely performance of any obligations existing under this Agreement.

	* Confidential Treatment Requested

16.

 

11.9 Severability. If any provision(s) of this Agreement are or become invalid, are ruled
illegal by any court of competent jurisdiction or are deemed unenforceable under then current
applicable law from time to time in effect during the term hereof, it is the intention of the
parties that the remainder of this Agreement shall not be effected thereby. It is further the
intention of the parties that in lieu of each such provision which is invalid, illegal or
unenforceable, there be substituted or added as part of this Agreement a provision which shall be
as similar as possible in economic and business objectives as intended by the parties to such
invalid, illegal or enforceable provision, but shall be valid, legal and enforceable.

11.10 Independent Contractors. It is expressly agreed that LICENSOR, on the one hand, and
LICENSEE, on the other hand, shall be independent contractors and that the relationship between the
two parties shall not constitute a partnership, joint venture or agency. Neither LICENSOR, on the
one hand, nor LICENSEE, on the other hand, shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall be binding on the
other, without the prior written consent of the other party to do so. All persons employed by a
party shall be employees of such party and not of the other party and all costs and obligations
incurred by reason of any such employment shall be for the account and expense of such party.

11.11 Survival. Sections 8.1, 11.6, 11.7 and 11.9 shall survive the expiration or
termination of this Agreement.

11.12 Counterparts. This Agreement may be executed in two counterparts, each of which shall
be enforceable against the party actually executing such counterpart, and both of which together
shall constitute one instrument.

11.13 Titles and Subtitles. The titles and subtitles used in this Agreement are used for
convenience only and are not considered in construing or interpreting this Agreement.

THE PARTIES have duly executed this Agreement as of the date first shown above written.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	LICENSOR	 	 	 	LICENSEE:
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Dr. MAURICE GITTOS	 	 	 	PRESTWICK SCIENTIFIC CAPITAL, INC.  
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	BY:

	 	 Marice Gittos  /s/	 	 	 	BY:	 	Kathleen Clarence-Smith  /s/	 	 	 	 	 	 
	

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	NAME:

	 	 	 	 	 	NAME:	 	 	 	 	 	 	 	 
	

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TITLE:

	 	 	 	 	 	TITLE:	 	 	 	 	 	 	 	 
	

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	DATE:

	 	 	 	 	 	DATE:	 	 	 	 	 	 	 	 
	

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 

17.

 

SCHEDULE 1.7

CHEMICAL FORMULA OF SALT AGN 2979

18.

 

SCHEDULE 1.11

DRAFT PATENT APPLICATION

[...***...]

	* Confidential Treatment Requested

19.

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