exv10w5






Exhibit 10.5








Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 230.406. The
confidential portions of this exhibit have been omitted and are marked accordingly. The
confidential portions have been filed separately with the Securities and Exchange Commission
pursuant to the Confidential Treatment Request.







LICENSE AGREEMENT




     THIS LICENSE AGREEMENT (this “Agreement”), effective as of September 23, 2009 (the
“Effective Date”), is entered into between SURMODICS PHARMACEUTICALS, INC., a Delaware
corporation (“SMP”), having a place of business at 750 Lakeshore Parkway, Birmingham,
Alabama 35211, U.S.A., and NUPATHE, INC., a Delaware corporation (“NUPATHE”), having a
place of business at 227 Washington Street, Suite 200, Conshohocken, Pennsylvania 19428, U.S.A.
with respect to the following facts:



     WHEREAS, SMP is the owner or exclusive licensee of certain technology, patent rights and
know-how rights related to the SMP Technology (as defined below);



     WHEREAS, NUPATHE is the owner or exclusive licensee of certain technology, patent rights and
know-how rights related to compositions and methods of the NUPATHE Technology (as defined below) in
conjunction with the Active Agent (as defined below);



     WHEREAS, NUPATHE desires to obtain from SMP and SMP desires to grant to NUPATHE, a license
under the SMP IP Rights (as defined below) upon the terms and conditions of this Agreement.



     NOW, THEREFORE, in consideration of the foregoing and the mutual covenants herein contained,
the parties hereby agree as follows:



     1. DEFINITIONS. Capitalized terms used in this Agreement and not otherwise defined
herein, shall have the meanings assigned to such terms in the Development Agreement.



          1.1 “Active Agent” shall mean the non-ergoline dopamine agonist known as ropinirole
(including the hydrochloride salt and free base).



          1.2 “Affiliate” shall mean, with respect to a party, any entity that controls or is
controlled by such party, or is under common control with such party. For purposes of this
definition, an entity shall be deemed to control another entity if it owns or controls, directly or
indirectly, at least fifty percent (50%) of the voting equity of another entity (or other
comparable interest for an entity other than a corporation).



          1.3 “Commercially Reasonable Efforts” shall mean those efforts and resources
consistent with the exercise of prudent scientific and business judgment, as applied to other
pharmaceutical products of similar market potential and market size and at a similar stage in the
development or life of such product and which are consistent with the general level of efforts and
resources in the pharmaceutical industry for a company similar in size and scope.



          1.4 “Confidential Information” shall mean all information and data that (a) is
provided by one party to the other party under this Agreement, and (b) if disclosed in writing or
other tangible medium is marked or identified as confidential at the time of disclosure to the
recipient, is acknowledged at the time of disclosure to be confidential, or otherwise should
reasonably be deemed to be confidential. Notwithstanding the foregoing, Confidential Information
of a party shall not include that portion of such information and data which, and only to the
extent, the recipient can establish by written documentation: (i) is known to the



1









 




recipient as evidenced by its written records before receipt thereof from the disclosing
party, (ii) is disclosed to the recipient free of confidentiality obligations by a third person who
has the right to make such disclosure, (iii) is or becomes part of the public domain through no
fault of the recipient, or (iv) the recipient can reasonably establish is independently developed
by persons on behalf of recipient without access to or use of the information disclosed by the
disclosing party (each, a “Confidentiality Exception”).




     1.5 “Delivery Matrix” shall mean the controlled delivery system comprising a
biodegradable matrix composed of [**] developed or optimized pursuant to the Development Program
for use by NUPATHE to deliver the Active Agent.



     1.6 “Development Agreement” shall mean that certain Feasibility Evaluation Agreement
between the parties dated March 19, 2007, as may be amended or restated from time to time by the
mutual written agreement of the parties.



     1.7 “Development Program” shall mean the development program conducted by the parties
pursuant to the Development Agreement.



     1.8 “Field” shall mean [**].



     1.9 “First Commercial Sale” shall mean the first sale of the Product by NUPATHE, its
sublicensee or their respective Affiliates to customers who are not Affiliates in any country after
all applicable marketing approvals (if any) have been granted by the applicable governing health
authority.



     1.10 “IND” shall mean an Investigational New Drug application or similar application
required to commence human clinical testing of a product submitted to the FDA or its foreign
equivalent.



     1.11 “Joint Research Inventions” shall mean those Research Inventions set forth in
Section 6(e) of the Development Agreement.



     1.12 “Joint Research IP Rights” shall mean, collectively, the Joint Research
Inventions and the Joint Research Patent Rights.



     1.13 “Joint Research Patent Rights” shall mean any Patent Rights that claim or cover
the Joint Research Inventions. Joint Research Patent Rights existing as of the Effective date are
set forth in Schedule 1.12 attached hereto, as may be amended from time to time.



     1.14 “Know-How” shall mean any and all proprietary technical information,
formulations, processes, data, specifications, characterization methods, characterization results,
and other proprietary information, excluding any Patent Rights with respect thereto.



     1.15 “Major European Country” shall mean any one of [**].





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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          1.16 “NDA” shall mean a New Drug Application or similar application for marketing
approval of a product submitted to the FDA or its foreign equivalent.



          1.17 “Net Sales” shall mean [**].



          1.18 “NUPATHE IP Rights” shall mean, collectively, the NUPATHE Patent Rights and the
NUPATHE Know-How Rights.



          1.19 “NUPATHE Know-How Rights” shall mean all Know-How owned and controlled by
NUPATHE, existing as of the Effective Date, that relates to the NUPATHE Technology and that is
reasonably necessary or useful to develop, obtain regulatory approval for, manufacture, use, or
otherwise commercially exploit the Active Agent or the Product in the Field. All NUPATHE Know-How
Rights that do not fall within the scope of a Confidentiality Exception shall be the Confidential
Information of NUPATHE.



          1.20 “NUPATHE Patent Rights” shall mean, collectively, all Patent Rights owned or
controlled by NUPATHE that claim or cover the NUPATHE Technology.



          1.21 “NUPATHE Research Inventions” shall mean those Research Inventions set forth in
Section 6(c) of the Development Agreement.



          1.22 “NUPATHE Research IP Rights” shall mean shall mean collectively the NUPATHE
Research Inventions and the NUPATHE Research Patent Rights.



          1.23 “NUPATHE Research Patent Rights” shall mean all Patent Rights that claim or cover
the NUPATHE Research Inventions.



          1.24 “NUPATHE Technology” shall mean, collectively, all compositions, formulations,
methods, processes, uses, technology, data and information, owned and controlled by NUPATHE and
existing as of the Effective Date, that comprise, are responsible for, derive or


result from
or relate to [**]; provided, however, that NUPATHE Technology shall exclude the Product and all
uses thereof. All NUPATHE Technology that does not fall within the scope of a Confidentiality
Exception shall be the Confidential Information of NUPATHE.



          1.25 “Patent Rights” shall mean any of the following, whether existing now or in the
future anywhere in the world (i) any issued patent, including inventor’s certificates,
substitutions, extensions, supplemental protection certificates, confirmations, reissues,
reexaminations, renewals, or any like governmental grant for protection of inventions and (ii) any
pending applications for any of the foregoing, including any continuation, divisional,
substitution, continuations-in-part, provisional and converted provisional applications.



          1.26 “Phase III Clinical Trial” shall mean a pivotal human clinical trial in any
country the results of which could be used to establish safety and efficacy of a product as a basis
for an NDA or that would otherwise satisfy requirements of 21 CFR 312.21(c).





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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          1.27 “Product” shall mean a biodegradable, preformed, macroscopic implant device
consisting of the Active Agent, as the sole active pharmaceutical ingredient, incorporated into the
Delivery Matrix.



          1.28 “Research Inventions” shall mean collectively all inventions, Know-How, trade
secrets, discoveries, development, methods, techniques, formulae, processes and compositions of
matter, whether or not patentable, resulting or derived from or directly relating to SMP’s and/or
NUPATHE’ s activities under the Development Agreement.



          1.29 “Royalty Term” shall mean, on a country-by-country basis, the period equal to the
longer of: (a) the date on which the Product ceases to be covered by a Valid Claim in such country
or (b) [**] from the date of the First Commercial Sale of the Product in such country.



          1.30 “SMP IP Rights” shall mean, collectively, the SMP Know-How Rights and the SMP
Patent Rights.



          1.31 “SMP Know-How Rights” shall mean all Know-How owned and controlled by SMP,
existing as of the Effective Date, that relates to the SMP Technology and that is reasonably
necessary or useful to develop, obtain regulatory approval for, manufacture, use, or otherwise
commercially exploit the Product in the Field. All SMP Know-How Rights that does not fall within
the scope of a Confidentiality Exception shall be the Confidential Information of SMP.



          1.32 “SMP Patent Rights” shall mean, collectively, the Patent Rights that claim or
cover the SMP Technology. The SMP Patent Rights existing as of the Effective Date and covered by
this Agreement are set forth on Schedule 1.32 attached hereto, as may be amended from time to time.



          1.33 “SMP Research Inventions” shall mean those Research Inventions set forth in
Sections 6(d) of the Development Agreement.



          1.34 “SMP Research IP Rights” shall mean collectively (a) the SMP Research Inventions,
and (b) the SMP Research Patent Rights.



          1.35 “SMP Research Patent Rights” shall mean all Patent Rights that claim or cover the
SMP Research Inventions.



          1.36 “SMP Technology” shall mean, collectively, all compositions, formulations,
methods, processes, uses, technology, data and information, owned and controlled by SMP and
existing as of the Effective Date, that comprise, are responsible for, derive or result from or
relate to [**]; provided, however, that SMP Technology shall exclude the Product and all uses
thereof. All SMP Technology that does not fall within the scope of a Confidentiality Exception
shall be the Confidential Information of SMP.



          1.37 “Sublicense” shall mean any license granted by NUPATHE (including its Affiliates or
sublicensees) of the rights granted under Section 3.1.1 (including without limitation





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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any promotion, marketing, distribution, joint venture or other arrangement conferring such rights
and intending to provide for the commercialization of products, including the Product) to a third
party.




          1.38 “Territory” shall mean all the countries in the world.



          1.39 “Valid Claim” shall mean either (a) a claim of an issued and unexpired patent
included within the SMP Patent Rights or SMP Research Patent Rights, which has not been held
permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which
has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or
(b) a claim of a pending patent application included within the SMP Patent Rights or SMP Research
Patent Rights, which claim was filed in good faith and has not been abandoned or finally disallowed
without the possibility of appeal or refiling of such application.



     2. REPRESENTATIONS AND WARRANTIES; COVENANTS.



          2.1 Mutual Representations and Warranties. Each party represents and warrants to the
other party as follows:




               2.1.1 Organization. Such party is duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is organized.



               2.1.2 Authorization and Enforcement of Obligations. Such party (a) has the requisite
power and authority and the legal right to enter into this Agreement and to perform its obligations
hereunder; and (b) has taken all requisite action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding
obligation, enforceable against such party in accordance with its terms.



               2.1.3 Consents. All necessary consents, approvals and authorizations of all
governmental authorities and other persons or entities required to be obtained by such party in
connection with this Agreement have been obtained.



               2.1.4 No Conflict. The execution and delivery of this Agreement and the performance
of such party’s obligations hereunder (a) do not conflict with or violate any requirement of
applicable laws, regulations or orders of governmental bodies; and (b) do not conflict with, or
constitute a default under, any contractual obligation of such party.



          2.2 NUPATHE Representations and Warranties. NUPATHE represents and warrants to SMP
that, as of the Effective Date:




               2.2.1 To the best of NUPATHE’S knowledge and belief NUPATHE has, sufficient and/or beneficial
title under the NUPATHE IP Rights to enable SMP to perform the activities contemplated under the
Development Program. To NUPATHE’s actual knowledge,



5









 




NUPATHE has not received any notice, claim or assertion from any third party that the use of
the NUPATHE IP Rights (including with respect to the Active Agent) in a manner contemplated under
the Development Program would constitute infringement or misappropriation of the intellectual
property rights of any third party.




          2.3 SMP Representations and Warranties: SMP represents and warrants to NUPATHE that,
as of the Effective Date:



               2.3.1 SMP is the owner of the SMP Patent Rights listed on Exhibit 1.32 and of the
items included in the SMP Know-How Rights and, as of the Effective Date, the Patent Rights listed
on Exhibit 1.32 are the only Patent Rights owned or controlled by SMP, or in which SMP has
any rights, that are directed to the SMP Technology or the Product in the Field.



               2.3.2 To SMP’s actual knowledge, SMP has not received any notice, claim or assertion from any
third party that the SMP IP Rights as incorporated into the Product would infringe or
misappropriate any intellectual property rights of any third party.



          2.4 DISCLAIMER OF WARRANTIES-SMP. EXCEPT AS EXPRESSELY SET FORTH IN THIS SECTION 2,
SMP MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE SMP IP RIGHTS,
INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING VALIDITY, ENFORCEABILITY,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. THE SMP IP RIGHTS ARE
PROVIDED “AS IS.”




          2.5 DISCALIMER OF WARRANTIES-NUPATHE. EXCEPT AS EXPRESSELY SET FORTH IN THIS SECTION 2,
NUPATHE MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE NUPATHE IP
RIGHTS, INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING VALIDITY,
ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. THE NUPATHE
IP RIGHTS ARE PROVIDED “AS IS.”




          2.6 NUPATHE Covenant. NUPATHE shall at all times during the term of this Agreement
comply and use Commercially Reasonable Efforts to cause its sublicensees and Affiliates to comply
with all laws that may control or apply to the research, testing, development, distribution or
marketing of the Product or any other activity undertaken pursuant to this Agreement.




     3. LICENSE GRANT.



          3.1 License Grant to NUPATHE.



               3.1.1 On the terms and conditions of this Agreement, SMP hereby grants to NUPATHE an exclusive,
even as to SMP, worldwide, royalty-bearing license under the SMP IP Rights, SMP Research IP Rights,
and SMP’s rights under the Joint Research IP Rights to





 




			
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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develop, make, have made, use, offer for sale, sell, have sold, export and import the Product for
use in the Field.




               3.1.2 NUPATHE shall have the right to grant Sublicenses (a) to third parties, other than
Affiliates, for the purpose of developing or commercializing the Product in each case jointly with,
or for the benefit of, NUPATHE, or (b) to Affiliates. NUPATHE shall remain responsible for all
payments due to SMP hereunder, and shall require that each of its sublicensees be bound by the
applicable terms of this Agreement. Without limiting the foregoing, any Sublicense agreement must
require that the sublicensee comply with the limitations of the license set forth in Section 3.1.1,
and confidentiality and non-use obligations (with respect to Confidential Information of SMP) that
are no less stringent than those set forth in Section 7, and must include an obligation of the
sublicensee to account for and report its Net Sales to NUPATHE on the same basis as if such Net
Sales were made by NUPATHE. Upon the written request of SMP, but no more frequently than once per
calendar quarter, NUPATHE shall provide to SMP a list of the third parties to which NUPATHE has
granted any Sublicense.



          3.2 License Grant to SMP.




               3.2.1 NUPATHE hereby grants to SMP an exclusive, worldwide, royalty free perpetual license
under NUPATHE’s rights in the Joint Research IP Rights for any and all uses that do not relate to
the Product or include NUPATHE Know-How Rights.



          3.3 Manufacturing Rights to SMP.




               3.3.1 NUPATHE hereby grants to SMP a right of first negotiation to manufacture supplies of the
Product for use in human clinical studies. NUPATHE will provide SMP with written notice of
NUPATHE’S intention to procure such clinical supplies and the proposed terms and conditions for the
manufacture, including but not limited to NUPATHE’S requirements for price, timeliness, Product
quality and Product quantity. SMP and NUPATHE will then negotiate for a period of up to [**] in an
effort to mutually agree to such terms and conditions for the manufacture of clinical supplies of
the Product. Should NUPATHE and SMP enter into a manufacturing agreement regarding clinical
supplies of the Product, SMP shall have a right of first negotiation to manufacture commercial
supplies of the Product. NUPATHE will provide SMP with written notice of NUPATHE’S intention to
procure such commercial supplies and the proposed terms and conditions for the manufacture,
including but not limited to NUPATHE’S requirements for price, timeliness, Product quality and
Product quantity. SMP and NUPATHE will then negotiate for a period of up to [**] in an effort to
mutually agree to such terms and conditions for the manufacture of commercial supplies of the
Product.



               3.3.2 In connection with any manufacturing agreement entered into between the Parties pursuant
to Section 3.3.1 above, NUPATHE will grant to SMP, for the term of such agreement, [**],
irrevocable, nonexclusive, worldwide license (with the right to grant sublicenses upon notice to
and the prior written consent of NUPATHE) as may be necessary to fulfill any manufacturing
obligations for the clinical or commercial supply of the Product under the NUPATHE IP Rights,
NUPATHE Research IP Rights and NUPATHE’S rights under the Joint Research IP Rights to make and have
made the Product solely for sale to NUPATHE, its sublicensees and their respective Affiliates.





 




			
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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          3.4 No Implied Licenses; Reservation of Rights. Only licenses and rights expressly
granted herein shall be of legal force and effect. No license or other right shall be created
hereunder by implication, estoppel or otherwise. NUPATHE acknowledges that SMP’s business involves
the application of the SMP IP Rights to numerous drugs and other products and that SMP retains the
right (expressly subject to SMP’s obligations under this Agreement or under any other agreement
between the Parties) to apply its technology to drugs or products owned by SMP or any third party
and to make, use or sell drugs or products owned by SMP or any third party. For the avoidance of
doubt, no license is conferred to NUPATHE under the SMP IP Rights, SMP Research IP Rights or SMP’s
rights under the Joint Research IP Rights to research, develop, make, have made, use, offer to
sell, sell, have sold, import, export or otherwise deal in or with any product, item, device or
technology other than the Product in the Field, and SMP retains and reserves all rights that are
not explicitly granted to NUPATHE herein including the sole and exclusive right to use and exploit
SMP IP Rights, SMP Research IP Rights and SMP’s rights under the Joint Research IP Rights to
research, develop, make, have made, use, offer to sell, sell, have sold, import, export or
otherwise deal in any product, process, item, device, machine or other apparatus that is not the
Product.




          3.5 Restriction. During the Term, SMP and its Affiliates (a) may not grant a license
under the SMP IP Rights, SMP Research IP Rights, or SMP’s rights under the Joint Research IP Rights
to any third party for the development, manufacture, use, sale, import or export of a Product; and
(b) may not, for its or their own account or for any third party, directly or indirectly develop,
manufacture, use, sell, import or export a Product that is covered by the SMP IP Rights, SMP
Research IP Rights, or SMP’s rights under the Joint Research IP Rights.




     4. FINANCIAL TERMS.



          4.1 Milestone Payments.




               4.1.1 In consideration for the rights granted hereunder, upon the terms and conditions
contained herein, NUPATHE shall pay to SMP the following milestone payments within thirty (30) days
of the first achievement by NUPATHE, its Affiliates or sublicensees of each of the corresponding
events (each a “Milestone Event”):



	 	 	 	 	 
	Milestone Event	 	Payment
	[**]
	 	 	 	 
	TOTAL
	 	$	4,750,000	 






               4.1.2 In addition to the milestones set forth above, following the achievement of the
Milestone Event set forth in Section 4.1.1(iv), NUPATHE shall also pay SMP (a) USD $[**] upon
approval of the Product for commercial sale for Restless Leg Syndrome (except in the event that
Restless Leg Syndrome was the first approved indication) or any other second indication and (b) USD
$[**] upon the approval of the Product for commercial sale for each additional separate and
distinct clinical indication.



          4.2 Royalties.






 




			
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AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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               4.2.1 Within [**] following the First Commercial Sale of the Product in each country, NUPATHE
shall give written notice to SMP thereof.



               4.2.2 In addition to the payments set forth in Section 4.1 above, and subject to the terms and
conditions of this Agreement, during the applicable Royalty Term, NUPATHE shall pay to SMP with
respect to each Product covered by a Valid Claim, a royalty of [**] ([**]%) percent of annual Net
Sales of the Product.



               4.2.3 If NUPATHE elects not to have SMP manufacture its needs for commercial supplies of the
Product, the royalty rate set forth in Section 4.2.2 above shall be increased to [**] ([**]%)
percent of annual Net Sales of the Product.



               4.2.4 If, during any calendar quarter during the applicable Royalty Term, the manufacture,
use, offer for sale, sale or import of the Product in the country in which manufactured, used,
offered for sale, sold or imported would not infringe a Valid Claim (if such Valid Claim were in an
issued patent) in such country, then the applicable royalty rate under Section 4.2.2 or 4.2.3 in
such country for such calendar quarter shall be [**].



          4.3 Royalty Reports.




               4.3.1 Within [**] after the end of each calendar quarter
following the First Commercial Sale of the Product by NUPATHE, its sublicensees or their respective
Affiliates, NUPATHE shall furnish to SMP a written report showing in reasonably specific detail, on
a country-by-country basis, (a) the gross sales of the Product sold by NUPATHE, its sublicensees
and their respective Affiliates during such calendar quarter and the calculation of Net Sales from
such gross sales; (b) the calculation of the royalties, if any, which shall have accrued based upon
such Net Sales; (c) the withholding taxes, if any, required by law to be deducted from such
royalties; and (d) the exchange rates, if any, used in determining the amount of United States
dollars.



               4.3.2 With respect to sales of the Product invoiced in United States dollars, all such amounts
shall be expressed in United States dollars. With respect to sales of the Product invoiced in a
currency other than United States dollars, all such amounts shall be expressed both in the currency
in which the sale is invoiced and in the United States dollar equivalent. The United States dollar
equivalent shall be calculated at a quarterly conversion rate for each foreign currency calculated
for the relevant quarter as the daily average of the noon buying rate in New York City for cable
transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank in
New York as these exchange rates are published at www.federalreserw.gov/releases/H10/hist. All
royalties payable hereunder shall be calculated based on Net Sales expressed in United States
dollars.



               4.3.3 NUPATHE shall keep complete and accurate records in sufficient detail to properly
reflect all gross sales and Net Sales and to enable the royalties payable to be determined.





 




			
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               4.3.4 All royalties shown to have accrued by each royalty report provided under this Section
4.3 shall be payable on the date such royalty report is due. Payment of royalties in whole or in
part may be made in advance of such due date.



          4.4 Audits.




               4.4.1 Upon the written request of SMP and not more than once in each calendar year, NUPATHE
shall permit an independent certified public accounting firm of nationally recognized standing,
selected by SMP and reasonably acceptable to NUPATHE, at SMP’s expense, to have access during
normal business hours to such records of NUPATHE as may be reasonably necessary to verify the
accuracy of the royalty reports hereunder for any year ending not more than [**] prior to the date
of such request. The accounting firm shall disclose to SMP only whether the reports are correct or
not and the specific details concerning any discrepancies. No other information shall be shared.



               4.4.2 If such accounting firm concludes that additional royalties were owed during the audited
period, NUPATHE shall pay such additional royalties within [**] of the date SMP delivers to NUPATHE
such accounting firm’s written report so concluding. The fees charged by such accounting firm
shall be paid by SMP; provided, however, if the audit discloses that the royalties payable by
NUPATHE for such period are more than [**] of the royalties actually paid for such period, then
NUPATHE shall pay the reasonable fees and expenses charged by such accounting firm.



               4.4.3 SMP shall treat all financial information subject to review under this Section 4.4 as
confidential, and shall cause its accounting firm to retain all such financial information in
confidence.



               4.4.4 Withholding Taxes. NUPATHE shall be entitled to deduct from the royalty
payments otherwise due to SMP hereunder the amount of any withholding taxes, value-added taxes or
other taxes, levies or charges with respect to such royalty payments that are required to be
withheld by NUPATHE, to the extent NUPATHE pays to the appropriate governmental authority on behalf
of SMP such taxes, levies or charges. NUPATHE promptly shall deliver to SMP proof of payment of
all such taxes, levies and other charges, together with copies of all communications from or with
such governmental authority with respect thereto.



          4.5 Payment Method. All payments by NUPATHE to SMP hereunder shall be in United
States Dollars in immediately available funds and shall be made by wire transfer from a United
States bank located in the United States to such bank account as designated from time to time by
SMP to NUPATHE.




          4.6 Interest. NUPATHE additionally shall pay SMP interest on all amounts due
hereunder which are not paid on or before the due date therefor (except amounts determined in
connection with an audit pursuant to Sections 4.4.1 and 4.4.2), calculated at a rate equal to the
lesser of one percent (1.0%) per month, or the maximum rate permitted by law, whichever is lower,
calculated on the number of days such payment is past due, compounded monthly.




     5. DEVELOPMENT PROGRAM.





 




			
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          5.1 Conduct. The parties shall perform their respective obligations under the
Development Agreement. Each party shall use its Commercially Reasonable Efforts to perform its
obligations under the Development Agreement within the proposed time schedules set forth therein.
Any intellectual property rights (including any know-how or patent rights) developed or conceived
by either party shall be governed in accordance with the terms of the Development Agreement.




          5.2 Term. The Development Program shall terminate upon the completion of the
activities described in the Development Agreement, or such other date as the parties mutually agree
in writing.




          5.3 No Warranty. SMP does not represent, warrant, or guarantee that the results or
outcome of the Development Program (or any portion thereof), or any products produced therefrom are
merchantable or satisfactory for any particular purpose, and there are no warranties, express or
implied, to such effect. NUPATHE bears the sole risk of acceptance, reliance on or use of the
results provided to NUPATHE by SMP under the Development Program.




     6. DEVELOPMENT AND COMMERCIALIZATION BY NUPATHE



          6.1 Responsibility.




               6.1.1 Except as otherwise set forth in the Development
Program and this Section 6.1, NUPATHE shall be solely responsible, at its sole cost, for conducting
the development, regulatory approval and commercialization of the Product, and shall own all
regulatory applications, filings, approvals and licenses for the Product.



          6.2 Diligence.




               6.2.1 NUPATHE shall use Commercially Reasonable Efforts to actively develop and obtain
regulatory approvals to market the Product in major markets throughout the world. Without limiting
the generality of the foregoing, NUPATHE shall achieve the following milestones within the
applicable period commencing on the Effective Date:



          [**]




          6.3 Development and Commercialization Reports. NUPATHE shall keep complete and
accurate records of its activities conducted under this Agreement and the results thereof.
Following the conclusion of the Development Program and until the First Commercial Sale in the
United States and the first Major European Country of the Product, within thirty (30) days after
the end of each June and December, NUPATHE shall prepare and provide SMP with a reasonably detailed
written report of the activities conducted under this Agreement, and the results thereof, through
such date of such report to develop and obtain regulatory approvals to market the Product in major
markets throughout the world.






 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





11









 





          6.4 Regulatory Communications.




          6.5 If the FDA or the governing health authorities of any country initiates any oral
communication with NUPATHE directly regarding the Delivery Matrix, NUPATHE shall have the right to
respond to such communication to the extent reasonably necessary or appropriate under the
circumstances; provided, however, that promptly thereafter, NUPATHE shall provide SMP with written
notice thereof in reasonably specific detail describing the communications regarding the Delivery
Matrix; and (c) NUPATHE promptly shall provide SMP with copies of all minutes and other materials
resulting therefrom.




          6.6 NUPATHE promptly shall provide SMP with copies of all (a) written communications from the
FDA or the governing health authorities of any country directly regarding the Delivery Matrix and
(b) filings, communications or other submission with the FDA or the governing health authorities of
any country directly regarding the Delivery Matrix.




          6.7 Adverse Event Reporting. Each party shall promptly notify the other party immediately
of any information that comes to such party’s attention concerning any serious or unexpected side
effect, injury, toxicity or sensitivity reaction, or any unexpected incidence, and



the severity thereof, associated with the clinical uses, studies, investigations, tests and marketing
of the Product. For purposes of this Section 6.7, “serious” shall mean an experience which (a)
results in the death, permanent or substantial disability, in-patient hospitalization or
prolongation of hospitalization, or (b) is a congenital anomaly, cancer, the result of an overdose
or life threatening (only if unrelated to primary disease); and “unexpected” shall mean (x) for a
nonmarketed product, an experience that is not identified in nature, severity or frequency in the
current clinical investigator’s confidential information brochure, and (y) for a marketed product,
an event which is not listed in the current labeling for such product, and includes an event that
may be symptomatically and pathophysiologically related to an experience listed in the labeling but
differs from the event because of increased frequency or greater severity or specificity. Each
party further shall promptly notify the other party of any information received regarding any
threatened or pending action by an agency that may affect the safety and efficacy claims of a
Product. Upon receipt of any such information, the parties shall consult with each other in an
effort to arrive at a mutually acceptable procedure for taking appropriate action; provided,
however, that nothing contained herein shall restrict either party’s right to make a timely report
of such matter to any government agency or take other action that it deems to be appropriate or
required by applicable law, regulation or court order.




     7. CONFIDENTIALITY.



          7.1 Confidentiality. During the term of this Agreement and for a period of [**]
following the expiration or earlier termination hereof, each party shall maintain in confidence the
Confidential Information of the other party, shall not use or grant the use of the Confidential
Information of the other party except as expressly permitted hereby, and shall not disclose the
Confidential Information of the other party except on a need-to-know basis to such party’s
Affiliates, directors, officers, employees, sublicensees, and consultants, to the extent such
disclosure is reasonably necessary in connection with such party’s activities as expressly
authorized by this Agreement. To the extent that disclosure to any person is authorized by this





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





12









 




Agreement, prior to disclosure, a party shall obtain written agreement of such person to hold
in confidence and not disclose, use or grant the use of the Confidential Information of the other
party except as expressly permitted under this Agreement. Each party shall notify the other party
promptly upon discovery of any unauthorized use or disclosure of the other party’s Confidential
Information.




          7.2 Additional Permitted Disclosures. Neither party shall disclose any terms or
conditions of this Agreement to any third party without the prior consent of the other party;
provided, however, that a party may disclose the terms or conditions of this Agreement, (a) on a
need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably
necessary, and (b) to a third party in connection with (i) an equity investment in such party, (ii)
a merger, consolidation or similar transaction by such party, or (iii) the sale of all or
substantially all of the assets of such party. Notwithstanding the foregoing, prior to execution
of this Agreement, the parties have agreed upon the substance of information that can be used to
describe the terms and conditions of this transaction, and each party may disclose such
information, as modified by mutual written agreement of the parties, without the consent of the
other party.




          7.3 Exceptions. The confidentiality obligations under this Section 7 shall not apply
to the extent that a party is required to disclose information by applicable law, regulation or
order of a governmental agency or a court of competent jurisdiction; provided, however, that such
party shall provide written notice thereof to the other party, consult with the other party with
respect to such disclosure and provide the other party sufficient opportunity to object to any such
disclosure or to request confidential treatment thereof




     8. INDEMNIFICATION AND INSURANCE.



          8.1 By NUPATHE. NUPATHE shall indemnify and hold harmless SMP, and its directors,
officers, employees and agents, from and against all losses, liabilities, damages and expenses,
including reasonable attorneys’ fees and costs (collectively, “Liabilities”), resulting from any
claims, demands, actions or other proceedings by any third party to the extent resulting from (a)
the breach of any representation, warranty or covenant by NUPATHE under this Agreement; (b) the
manufacture, use, sale, handling or storage of the Product by or on behalf of NUPATHE, its
sublicensees or their respective Affiliates, customers or end-users (including with respect to the
infringement or misappropriation of intellectual property rights of third parties); or (c) the use
of the Confidential Information of SMP by NUPATHE, its sublicensees or their respective Affiliates.
NUPATHE’s indemnity obligation under this Section 8.1 will not apply where the basis for the
Liabilities is the negligence or willful malfeasance of SMP or SMP’s breach of its representations,
warranties and agreements contained herein.




          8.2 By SMP. SMP shall indemnify and hold harmless NUPATHE, and its directors, officers,
employees and agents, from and against all Liabilities resulting from any claims, demands, actions
or other proceedings by any third party to the extent resulting from (a) the breach of any
representation, warranty or covenant by SMP under this Agreement; or (b) the use by SMP of the
Confidential Information of NUPATHE. SMP’s indemnity obligation under this Section 8.2 will not
apply where the basis for the Liabilities is the negligence or willful






13









 







malfeasance of NUPATHE or NUPATHE’s breach of its representations, warranties and agreements
contained herein.




          8.3 Procedure. If a party (the “Indemnitee”) intends to claim indemnification
under this Section 8, it shall promptly notify the other party (the “Indemnitor”) in
writing of any claim, demand, action or other proceeding for which the Indemnitee intends to claim
such indemnification, and the Indemnitor shall have the right to participate in, and, to the extent
the Indemnitor so desires, to assume the defense thereof with counsel mutually satisfactory to the
parties; provided, however, that an Indemnitee shall have the right to retain its own counsel, with
the reasonable fees and expenses to be paid by the Indemnitor, if representation of such Indemnitee
by the counsel retained by the Indemnitor would be inappropriate due to actual or potential
differing interests between the Indemnitee and any other party represented by such counsel in such
proceeding. The obligations of this Section 8 shall not apply to amounts paid in settlement of any
claim, demand, action or other proceeding if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver
written notice to the Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall relieve the Indemnitor of any
obligation to the Indemnitee under this Section 8. The Indemnitee, its employees and agents, shall
reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any
claim, demand, action or other proceeding covered by this Section 8.




          8.4 Insurance. Each party shall maintain insurance, including product liability and
general liability insurance, with respect to its activities under this Agreement regarding the
Product in such amount as such party customarily maintains with respect to similar activities for
its other products, but not less than such amount as is reasonable and customary in the industry
for companies of comparable size and activities. Each party shall maintain such insurance for so
long as it continues its activities under this Agreement, and thereafter for so long as such party
customarily maintains insurance for itself covering similar activities for its other products.




     9. PATENTS AND INFRINGEMENT.



          9.1 Prosecution of SMP Patent Rights and SMP Research Patent Rights.




               9.1.1 SMP shall have the sole and absolute right, at its sole expense, to exercise control
over the SMP IP Rights and the SMP Research IP Rights, including but not limited to, responsibility
for prosecuting, maintaining, abandoning and obtaining Patent Rights and other similar
registrations related to the SMP Patent Rights or the SMP Research Patent Rights. SMP shall (a)
consider in good faith the interests of NUPATHE in so doing, (b) keep NUPATHE reasonably informed
with respect to such activities, including providing to NUPATHE complete copies of all patents and
patent applications that claim or cover the Product; and (c) consult in good faith with NUPATHE
regarding such matters, including the modification or abandonment of any claims thereof covering a
Product for use in the Field.



               9.1.2 In the event SMP wishes to abandon any patent, patent application or claim within the SMP
Patent Rights or SMP Research Patent Rights that claims or covers the Product, SMP will offer to
assign, free of charge, any such patent to NUPATHE prior to



14









 






effectuating the abandonment. Should NUPATHE elect to become an assignee of such SMP Patent Rights
or SMP Research Patent Rights, NUPATHE will bear the costs connected to any assignment hereunder
and shall have the right to prosecute and maintain such patent, patent application or claim at its
sole expense.




          9.2 Prosecution of Joint Research Patents.




               9.2.1 With respect to all Joint Research Inventions, the parties shall determine which party
shall be responsible for filing, prosecuting, maintaining and defending Joint Research Patent
Rights on behalf of both parties (the “Responsible Party”) based on a good faith
determination of the relative contributions of the parties to the invention and the relative level
of interest of the parties in the invention.



               9.2.2 At least [**] prior to the contemplated filing of any patent applications related to
Joint Research Inventions, the Responsible Party shall submit a substantially completed draft
application to the other party for its approval, which shall not be unreasonably withheld or
delayed. The other party shall also execute such documents and perform such acts as may be
reasonably necessary to prepare, file, prosecute or maintain any such Joint Research Patent Rights.



               9.2.3 Except as set forth below, the parties shall share equally the costs of the
preparation, filing, prosecution and maintenance of all Joint Research Patent Rights. If the
Responsible Party does not wish to file, prosecute or maintain any Joint Research Patent Rights in
a particular country, it shall grant the other party any necessary authority to file, prosecute or
maintain such Joint Research Patent Rights. If either party elects not to pay its portion of any
shared costs in connection with the filing, prosecution, or maintenance of any particular Joint
Research Patent Rights, the other party may file, prosecute, or maintain such Joint Research Patent
Rights in its own name and at its sole expense, in which case the party electing not to pay its
share of costs shall assign its entire right, title and interest in and to Joint Research Patent
Rights to the other party.



          9.3 Enforcement.



               9.3.1 Notice. At any time during the term of this Agreement, SMP and NUPATHE shall
each promptly notify the other in writing upon learning of any Infringing Product. As used herein,
“Infringing Product” shall mean any product sold by a third party in the Field that (a) is
formulated as a biodegradable, preformed, macroscopic implant device composed of [**]; (b) contains
the Active Agent; and (c) infringes or is alleged to infringe any of the SMP IP Rights or the Joint
Research IP Rights licensed to NUPATHE hereunder covering a Product.



               9.3.2 SMP IP Rights. SMP shall have the sole right, at its discretion and expense, to
enforce the SMP IP Rights and any SMP Research IP Rights against an Infringing Product to the
extent such enforcement relates to the SMP Technology. Upon receipt of a written notice from
NUPATHE requesting that SMP initiate legal proceedings against an Infringing Product, SMP agrees
that it shall use its Commercially Reasonable Efforts to evaluate (a) whether it believes that such
Infringing Product infringes the SMP Patent Rights or the SMP





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





15









 




Research IP Rights, and (b) the merits of any and all appropriate legal actions that may be
brought against such third party to enforce the SMP Patent Rights or the SMP Research IP Rights,
taking into consideration such factors as the likelihood of success on the merits of any such
action, the likelihood that any such action might impair or otherwise affect the scope of such
Patent Rights, the likelihood that failure to initiate legal proceedings might impair or otherwise
negatively affect NUPATHE’s ability to commercialize Product and other similar factors. In the
event that SMP initiates an enforcement action, NUPATHE shall assist SMP in connection with any
such action, upon request and at SMP’s sole expense, and to the extent commercially reasonable; and
in any event, SMP shall keep NUPATHE reasonably informed of the progress of any such enforcement
action. Any settlement or recovery shall be distributed in the following order: (i) to SMP for
reimbursement of expenses related to such claim, including but not limited to attorneys’ fees and
expenses associated with the legal proceedings; and (ii) [**] percent ([**]%) to NuPathe and [**]
([**]%) to SMP for damages related to the infringement, including lost profits. SMP shall not make
any settlement or compromise that adversely affects the interests of NUPATHE in respect of the
Product in the Territory without the prior consent of NUPATHE.




                    9.3.2.1 Notwithstanding the foregoing, in the event SMP chooses not to initiate an enforcement
action, NUPATHE shall have the right but not the obligation to initiate and prosecute such an
action at its cost and expense provided, however that SMP shall use its Commercially Reasonable
Efforts to cooperate with NUPATHE, at NUPATHE’s sole expense. The amount of any settlement or
recovery obtained in such enforcement action shall be retained by NUPATHE, except that SMP shall
receive a portion equivalent to the royalties it would have received in accordance with the terms
of this Agreement as if such amount were Net Sales of NUPATHE. NUPATHE shall not make any
settlement or compromise that adversely affects the interests of SMP without the prior consent of
SMP.



                    9.3.2.2 If neither party brings an enforcement action against an Infringing Product in any
country, royalty payments payable by NUPATHE pursuant to Section 4 of this Agreement shall be [**]
in such country.



               9.3.3 Joint Research IP Rights.



                    9.3.3.1 NUPATHE shall have the right, at its discretion and expense to enforce Joint IP Rights
against an Infringing Product to the extent such enforcement relates to the Product for use in the
Field. If both parties wish to participate in such action, the action shall be brought jointly by
both parties and they will jointly select counsel and equally share any expenses. The parties
shall use their Commercially Reasonable Efforts to cooperate with each other in connection with any
such action to enforce Joint IP Rights.



                    9.3.3.2 Any settlement or recovery shall be distributed in the following order: (i) to NUPATHE
(or pro rata to each party if the parties proceed jointly) for reimbursement of expenses related to
such claim, including but not limited to attorneys’ fees and expenses associated with the legal
proceedings; (ii) to NUPATHE for any damages related to the license rights granted to it, including
lost profits related to sales of Product in the Field; provided, however, that any such amounts
(after relevant adjustment to convert to Net Sales of Products)




 




			
	**	 	
 CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.






16









 




shall be subject to the royalty obligations under this Agreement; and (iii) to the extent any
settlement or recovery remains, [**].




                    9.3.3.4 No settlement, consent judgment or other voluntary final disposition of a suit under
this Section 9.3.3 may be undertaken without the prior consent of the other party if such
settlement would require the other party to be subject to an injunction or to make a monetary
payment or would otherwise adversely affect the other party’s rights under this Agreement or the
validity of the Joint Research IP Rights.



                    9.3.3.5 SMP Costs. In any action brought by NUPATHE pursuant to this Section 9.3.3 (other
than an action brought jointly by the Parties) in which SMP is named or becomes involuntarily
involved (including, for example, as a result of a counterclaim by NUPATHE, or is required to
respond to a subpoena), NUPATHE shall indemnify and hold SMP harmless from any damages,
liabilities, costs or expenses resulting from any such action, and in such event, SMP may be
represented by counsel of its own choice, and NUPATHE shall promptly reimburse SMP for its costs of
retaining counsel.



          9.4 Infringement of Third Party Rights.




               9.4.1 In the event that a party becomes aware of any claim that the development, manufacture, use,
sale, offer for sale, export or import of the Product in the


Territory infringes the
intellectual property rights of a third party, such party will promptly notify the other party.




               9.4.2 NUPATHE shall be responsible for defending the parties against any claim by a third
party that the development, manufacture, use, sale, offer for sale, export or import of a Product
in the Territory infringes third party intellectual property rights. NUPATHE shall indemnify and
hold SMP harmless in accordance with Section 8, above. SMP shall assist NUPATHE in connection with
any such action to the extent commercially reasonable and at NUPATHE’s sole expense.



     10. TERM AND TERMINATION.



          10.1 Term. This Agreement shall commence on the Effective Date and, unless earlier
terminated pursuant to this Section 10, shall continue in effect until the expiration of NUPATHE’s
obligation to pay royalties hereunder after which time, the licenses granted to NUPATHE with
respect to the Product in the applicable country, subject to applicable patent laws, shall become a
perpetual, exclusive license deemed fully paid-up.



          10.2 Termination by SMP. If NUPATHE has breached its obligations under Section 6.2,
and such breach shall continue for [**] after written notice of such breach was provided, then as
its sole remedy for such breach, SMP shall have the right at its option either (a) to terminate
this Agreement, or (b) to convert the license granted to NUPATHE to non-exclusive, in either case
effective upon written notice to NUPATHE.





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





17









 





          10.3 Termination by NUPATHE. NUPATHE may terminate this Agreement at any time upon
ninety (90) days prior written notice to SMP.



          10.4 Termination by SMP or NUPATHE.



               10.4.1 Upon the occurrence of any of the events set forth below, SMP shall have the right to
terminate this Agreement by giving written notice of termination, such termination effective with
the giving of such notice:



                    10.4.1.1 In the event of nonpayment of any material amount payable to SMP, which nonpayment is
continuing [**] after SMP gives NUPATHE written notice of such non-payment;



                    10.4.1.2 In the event that NUPATHE is adjudged bankrupt, files or has filed against it any
petition under any bankruptcy, insolvency or similar law, has a receiver appointed for its business
or property, or makes a general assignment for the benefit of its creditors (each a “Bankruptcy
Event”) provided, however, that so long as SMP continues to receive all royalty
payments from NUPATHE under this Agreement, a Bankruptcy Event shall not, in and of itself, be a
basis for termination of this Agreement by SMP;



               10.4.2 Upon the occurrence of any of the events set forth below, NUPATHE shall have the right
to terminate this Agreement by giving written notice of termination, such termination effective
with the giving of such notice:



                    10.4.2.1 Breach by SMP of any covenant or any representation or warranty contained in this
Agreement that is continuing [**] after NUPATHE gives written notice of such breach;



                    10.4.2.2 Material breach or default by SMP with respect to any term or provision contained in
this Agreement that is continuing [**] after NUPATHE gives written notice of said breach or
default;



                    10.4.2.3 SMP becomes subject to a Bankruptcy Event; or



                    10.4.2.4 The dissolution or cessation of operations by SMP.



               10.4.3 Except as set forth in Section 10.2, above, no exercise by SMP or NUPATHE of any right
of termination shall constitute a waiver of any right of SMP or NUPATHE for recovery of any monies
then due to it hereunder or any other right or remedy SMP or NUPATHE may have at law or under this
Agreement.



          10.5 Effect of Expiration or Termination.




               10.5.1 Expiration or termination of this Agreement shall be without prejudice to any rights
which shall have accrued to the benefit of a party prior to such expiration or termination.
Without limiting the foregoing, [**] shall survive any expiration or termination of this Agreement.





 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





18









 








               10.5.2 Except as otherwise expressly set forth in this Agreement, promptly upon the expiration
or earlier termination of this Agreement, (a) NUPATHE promptly shall prepare and provide SMP with a
final royalty report through the date of expiration or termination, and shall pay to SMP all
royalties owing through such date, and (b) each party shall return to the other party all tangible
items regarding the Confidential Information of the other party and all copies thereof; provided,
however, that each party shall have the right to retain one (1) copy for its legal files for the
sole purpose of determining its obligations hereunder.



     11. MISCELLANEOUS.



          11.1 Governing Law. This Agreement shall be governed by, interpreted and construed in
accordance with the laws of the State of [**], without regard to the conflicts of law principles
thereof.




          11.2 Waiver. No waiver by a party hereto of any breach or default of any of the
covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or
similar breach or default.




          11.3 Assignment. Neither this Agreement nor any right or obligation hereunder may be
assigned or delegated, in whole or part, by either party without the prior express written consent
of the other; provided, however, that either party may, without the written consent of the other,
assign this Agreement and its rights and delegate its obligations hereunder in connection with the
transfer or sale of all or substantially all of its business, or in the event of its merger,
consolidation, change in control or similar transaction. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. Any purported assignment in violation of this
Section 11.3 shall be void.




          11.4 Independent Contractors. The relationship of the parties hereto is that of
independent contractors. The parties hereto are not deemed to be agents, partners or joint
venturers of the others for any purpose as a result of this Agreement or the transactions
contemplated thereby.




          11.5 Further Actions. Each party shall execute, acknowledge and deliver such further
documents and instruments and to perform all such other acts as may be necessary or appropriate in
order to carry out the purposes and intent of this Agreement.




          11.6 Notices. All requests and notices required or permitted to be given to the
parties hereto shall be given in writing, shall expressly reference the section(s) of this
Agreement to which they pertain, and shall be delivered to the other party, effective on receipt,
at the appropriate address as set forth below or to such other addresses as may be designated in
writing by the parties from time to time during the term of this Agreement.




	 	 	 	 	 

	     If to SMP:

	 	SurModics Pharmaceuticals Inc.

750 Lakeshore Parkway

Birmingham, Alabama 35211

U.S.A.

Attn: President








 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





19









 







	 	 	 	 	 

	 

	 	with a copy to:
	 	SurModics, Inc

9924 West 74th Street

Eden Prairie, Minnesota 55344

U.S.A.

Attention: General Counsel

	 
	 	 	 	 
	 

	 	If to NUPATHE:
	 	NUPATHE Inc.

227 Washington Street, Suite 200

Conshohocken, PA 19428

U.S.A.

Attn: Chief Executive Officer
	 
	 	 	 	 
	 

	 	With a copy to:
	 	NUPATHE Inc.

227 Washington Street, Suite 200

Conshohocken, PA 19428

U.S.A.

Attn: General Counsel






          11.7 Force Majeure. Nonperformance of a party (other than for the payment of money)
shall be excused to the extent that performance is rendered impossible by strike, fire, earthquake,
flood, governmental acts or orders or restrictions, failure of suppliers, or any other reason where
failure to perform is beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of the nonperforming party; provided, however, that the nonperforming party
shall use Commercially Reasonable Efforts to resume performance as soon as reasonably practicable.




          11.8 No Consequential Damages. IN NO EVENT SHALL A PARTY BE LIABLE FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS
HEREUNDER, INCLUDING WITHOUT LIMITATION LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 11.8 IS INTENDED TO
LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 8 ABOVE.




          11.9 Complete Agreement. This Agreement constitutes the entire agreement between the
parties regarding the subject matter hereof, and all prior representations, understandings and
agreements regarding the subject matter hereof, either written or oral, expressed or implied, are
superseded and shall be and of no effect.




          11.10 Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed to be an original and together shall be deemed to be one and the same agreement.




          11.11 Headings. The captions to the several sections hereof are not a part of this
Agreement, but are included merely for convenience of reference only and shall not affect its
meaning or interpretation.




20









 






     IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their
duly-authorized representatives as of the Effective Date.



	 	 	 	 	 	 	 

	 	 	SURMODICS PHARMACEUTICALS, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Arthur J. Tipton
 

	 	 
	 

	 	Name:
	 	Arthur J. Tipton, Ph.D.	 	 
	 

	 	Title:
	 	President	 	 
	 
	 	 	 	 	 	 
	 	 	NUPATHE, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Keith A. Goldan
 


	 	 
	 

	 	Name:
	 	Keith A. Goldan	 	 
	 

	 	Title:
	 	 Vice President & CFO	 	 






21









 





     SCHEDULES TO BE ATTACHED



22









 





CONFIDENTIAL INFORMATION




Joint Research IP Rights

Schedule 1.12




	 	 	 	 	 	 	 
	Patent/Appl No.	 	Title	 	Inventors	 	Brief Description
	[**]

	 	[**]
	 	[**]
	 	[**]








 




			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.















 






CONFIDENTIAL INFORMATION




SurModics Pharmaceuticals Patent Rights

Schedule 1.32




	 	 	 	 	 	 	 
	Patent/Appl No.	 	Title	 	Inventors	 	Brief Description
	11/196,591

	 	Methods for
manufacturing

delivery systems
and 
systems thereof
	 	Jay K. Staas

Thomas R. Tice

Bruce W. Hudson

Arthur J. Tipton
	 	Use of solevnt to

modify the implant

surface and modify

drug release

profile
	 
	 	 	 	 	 	 
	[**]

	 	[**]
	 	[**] 	 	[**]
	[**]

	 	[**]
	 	[**] 	 	[**]
	[**]

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