Document:

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

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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).

 

			
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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) ten (10) years 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

 

			
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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,

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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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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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          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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               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:

	 	 	 	 	 
	 	Period	 	Milestone	 
	 
	 	[**]	 	[**]	 

          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.

 

			
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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

 

			
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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)

 

			
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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.

 

			
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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 Delaware, 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

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
	[**]

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

 

			
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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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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.exv10w11

Exhibit 10.11

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.

EQUIPMENT FUNDING AGREEMENT

This EQUIPMENT FUNDING AGREEMENT (this “Agreement”), is entered into as of 1 day of June, 2010
(“Effective Date”) by and between
NuPathe Inc., a Delaware corporation with its principal place of business at 227 Washington Street,
Suite 200, Conshohocken, PA 19428 USA (“NuPathe”)
and

LTS LOHMANN Therapie-Systeme AG., a German corporation with its principal place of business at
Lohmannstr. 2, 56626 Andernach, Germany (“LTSAG”).
Each of NuPathe and LTS AG shall be a “Party,” and together shall be referred to as the “Parties.”

RECITALS

     WHEREAS, LTS LOHMANN Therapie-Systeme AG (“LTS AG”) and NuPathe entered into a Development and
License Agreement dated September 14, 2007 regarding sumatriptan succinate, as amended on April 1,
2008, February 17, 2009, and on May 10, 2010 (the “Development Agreement”), pursuant to which LTS
AG and NuPathe cooperated on the development of a Product (as defined therein); and

     WHEREAS, the Parties or its affiliates intend to negotiate a commercial manufacturing
agreement, (the “Manufacturing Agreement”) which, if executed, would provide for NuPathe providing
the E-Card (as defined below) to LTS AG or its affiliates and for LTS AG or its affiliates to [**]
and to manufacture the Drug Product (as defined below) in order to supply such Commercial
Components (as defined below) to NuPathe for commercial use in accordance with, as applicable, the Development Agreement and/or the
Manufacturing Agreement, and

 

			
	**	 	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.

 

 

     WHEREAS, in order to manufacture Commercial Components under the Manufacturing
Agreement, the purchase of Commercial Equipment and the Installation Activities ( both as defined
below) are necessary; and

     WHEREAS, NuPathe is willing to fund the purchase of the Commercial Equipment and reimburse LTS
AG for the costs of the Installation Activities in accordance with the terms of this Agreement;

     NOW THEREFORE, NuPathe and LTS AG, in consideration of the mutual agreements and covenants
hereinafter contained, the receipt and sufficiency of which are hereby acknowledged, and intending
to be legally bound, do each hereby agree, as hereinafter set forth:

1. Definitions

As used herein, the following terms will have the meanings set forth below:

	1.1	 	“API” shall mean sumatriptan succinate which meets the specifications agreed to in writing by
the Parties pursuant to the Manufacturing Agreement.
	 
	1.2	 	“Commercial Components” shall mean the Drug Product and the E-Patch.
	 
	1.3	 	“Commercial Equipment” shall mean the equipment listed on Annex 1 which is required for the
manufacture of Commercial Components.
	 
	1.4	 	“Commercially Reasonable Efforts” shall mean those efforts employed by the Parties,
equivalent to that level of attention and care that they devote to their other
businesses and products of similar commercial potential and at a similar stage of progress of
development.

	1.5	 	“Current GMP or cGMP” shall mean then current Good Manufacturing
Practices promulgated by the United States Food & Drug Administration (FDA) and its

 

 

	 	 	counterpart governmental agencies outside the United States, in the form of laws, regulations
or guidance documents, including those practices and standards set forth in Current Good
Manufacturing Practice Regulations of the US Code of Federal Regulations Title 21 (21 CFR
§§210,211 and 820) in relation to the production of pharmaceutical products and medical
devices and those practices and standards provided for (as amended from time to time) in the
European Community Directive 91/356/EEC, as interpreted by the ICH Harmonized Tripartite
Guideline, and any arrangements, additions or clarifications agreed from time to time between
the Parties.

	1.6	 	“Drug Product” shall mean the drug product reservoir card containing the API in accordance
with specifications set forth in the Quality Agreement and the Manufacturing Agreement.
	 
	1.7	 	“E-Card” shall mean the portion of the NuPathe Patch necessary for its iontophoretic
operation and provided as a unit to LTS AG or its affiliates for [**].
	 
	1.8	 	“Encumbrance” shall mean any lien; pledge; hypothecation; mortgage; security interest;
escrow; charge; equity interest; option; right of first refusal; preemptive right; obligation;
undertaking; license; claim; demand; community property right or interest; joint management,
control, or disposition right or interest; or any other restriction, condition or encumbrance
of any kind, including any restriction on
use, transfer, receipt of income, or exercise of any other attribute of ownership or
possession.
	 
	1.9	 	“E-Patch” shall mean the patch resulting from [**].

 

			
	**	 	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.

 

 

	1.10	 	“Facility” shall mean an LTS
AG or its affiliates’ cGMP manufacturing facility for the Commercial Components.
	 
	1.11	 	“Installation Activities” shall mean equipment ordering, build, installation, start-up and
qualification in compliance with all Regulatory Requirements and cGMP with the goal to make
the Commercial Equipment fully operable and such that, subject to successful scale-up and
validation of the manufacturing process for the Commercial Equipment, it can be used to
manufacture the Commercial Components
	 
	1.12	 	“NuPathe Patch” shall mean the E-Patch combined with the Drug Product.
	 
	1.13	 	“Quality Agreement” shall mean the then-current quality assurance procedures as mutually
agreed upon by the Parties in writing in connection with the commercial manufacture of the
Commercial Components.
	 
	1.14	 	“Regulatory Requirements” shall mean all laws, regulations and other legal requirements
applicable to the manufacture of the Commercial Components, including without limitation cGMP,
FDA regulations, ICH guidelines, any applicable local laws and regulations in the place of
manufacture, storage and handling, and any requirements set forth in any IND, NDA, 510k,
applications for marketing approval and other regulatory filings or approvals for the NuPathe
Patch as the same may be enacted or modified from time-to-time.

2. Purchase/Installation

	2.1	 	Purchase. Subject to Section 3.2, LTS AG agrees to purchase the Commercial Equipment
by placing purchase orders in accordance with the schedule set forth in the project plan,
which is attached hereto as Annex 2 (the “Project Plan”). LTS 

 

 

	 	 	AG represents that, to the best
of its knowledge and subject to successful scale-up and validation, the Commercial Equipment
should comply with the requirements which are attached hereto as Annex 3 (the “Requirements”).

	2.2	 	Installation Activities. Subject to the timely receipt of NuPathe’s payments as set
forth in the payment schedule attached hereto as Annex 4 (the “Payment Schedule”), LTS AG
shall use its Commercially Reasonable Efforts to perform the Installation Activities and to
perform those in accordance with the Project Plan.

	 	(a)	 	In the event that LTS AG becomes aware that the Commercial Equipment will not meet
the Requirements or the Installation Activities will not be completed in accordance with
the Project Plan, then LTS AG shall immediately notify NuPathe in writing. In such event,
LTS AG and NuPathe shall jointly agree in writing to necessary changes, if any, to the
Commercial Equipment or Installation Activities or Project Plan. If the amounts in the
Payment Schedule for the purchase of the Commercial Equipment or the man-hours set forth
therein for the Installation Activities are not sufficient, the Parties shall discuss in
good faith coverage of the costs for completion of the purchase of the Commercial
Equipment and the Installation Activities. LTS AG shall not spend any amounts or
man-hours exceeding the Payment Schedule or Project Plan, as applicable, without the prior
written agreement of the Parties.
	 
	 	(b)	 	In the event that NuPathe requests a material change to the Commercial Equipment or
Project Plan (a “Material Change”), LTS AG shall provide NuPathe with a revised Payment
Schedule and Project Plan and shall provide an overview of non-cancellable obligations
that LTS AG has in connection with the Commercial

 

 

	 	 	 	Equipment and the costs related thereto.
LTS AG shall not change the Commercial Equipment or revise the Project Plan without the
prior written agreement of the Parties.
	 
	 	 	 	In the event that due to a Material Change non-cancellable obligations of LTS AG become
obsolete, then NuPathe shall cover those costs. LTS AG shall in any event use its
reasonable best efforts to minimize those costs after the Parties reached agreement to
actually change the Commercial Equipment or the Project Plan.

3. Funding/Payment

	3.1	 	NuPathe Funding. NuPathe agrees to provide LTS AG with the funds necessary to
purchase the Commercial Equipment and complete the Installation Activities for each line.
Except as agreed upon according to Section 2.2, NuPathe shall not be liable for any payments
in excess of the amounts set forth in the Payment Schedule.
	 
	3.2	 	Payment Schedule. NuPathe shall make such payments based upon LTS AG’s invoices and
in accordance with the Payment Schedule. Payments shall be made by NuPathe within thirty (30)
days of receipt of LTS AG’s invoice. It is understood that any placement of a purchase order
by LTS AG for the purchase of Commercial Equipment is subject to the prior receipt by LTS AG
of the applicable payment by NuPathe. In the event that NuPathe fails to pay LTS AG for the Installation
Activities in time, LTS AG may suspend the performance of the Installation Activities until
all outstanding amounts are paid in full.

 

 

	 	 	For clarity, LTS AG shall not be in breach of this Agreement as a result of LTS AG’s
failure to perform in accordance with the Project Plan as a result of NuPathe’s failure to
timely make any payment due hereunder.

	3.3	 	NuPathe Audit. Upon reasonable notice, LTS AG shall make available to NuPathe for
review and audit all invoices and other documents related to the costs and expenses associated
with the purchase of and Installation Activities related to the Commercial Equipment.

4. Ownership

	4.1	 	Title. LTS AG shall have title to and be the owner the Commercial Equipment
subject to the following conditions:

	 	(a)	 	During the term of the Development Agreement or the Manufacturing Agreement
LTS AG shall not sell or otherwise dispose of the Commercial Equipment, provided that
LTS AG may transfer ownership to LTS Lohmann Therapy Systems Partnership L.P. (“LTS
Partnership”), provided, however, that LTS Partnership agrees, in writing to be bound
by the terms of this Agreement and that such transfer shall not relieve LTS AG of its
obligations or liability under this Agreement;
	 
	 	(b)	 	During the term of the Development Agreement or any Manufacturing Agreement,
LTS AG shall not permit, and shall take all necessary action to prevent, any
Encumbrance on the Commercial Equipment.

	4.2	 	Transfer of Title

	 	(a)	 	In the event that the Parties do not execute Manufacturing Agreement, LTS AG
will at LTS AG’s sole discretion either transfer ownership of the Commercial 

 

 

	 	 	 	Equipment
to NuPathe or refund the book value of the Commercial Equipment (i.e. purchase price
minus cumulative depreciation costs) under this Agreement. The depreciation schedule
and book value for the Commercial Equipment is set forth in Annex 5.
	 	(b)	 	In the event NuPathe Terminates this Agreement as a result of a breach of
this Agreement by LTS AG, LTS AG will at LTS AG’s sole discretion either transfer
ownership of the Commercial Equipment to NuPathe or refund the book value of the
Commercial Equipment (i.e. purchase price minus cumulative depreciation costs) under
this Agreement. The depreciation schedule and book value for the Commercial Equipment
is set forth in Annex 5.
	 
	 	(c)	 	In the event LTS AG, at its sole discretion pursuant to Sections 4(a) or
(b), above, decides to transfer the Commercial Equipment to NuPathe, LTS AG shall
transfer the Commercial Equipment to NuPathe or its designee at NuPathe’s expense and
shall provide NuPathe with technology transfer assistance from personnel skilled in
such manufacturing operations at NuPathe’s cost, at agreed reasonable and customary
rates; provided, however, that in the event NuPathe terminated this Agreement as a
result of a breach of this Agreement by LTS AG, then such technology transfer
assistance shall be free of charge. LTS AG shall use Commercially Reasonable Efforts,
at the request of NuPathe, to assist with such equipment transfer and technology
transfer.

	4.3	 	Maintenance/Repair. LTS AG shall be responsible for and shall bear the cost of all
routine maintenance and repair for the Commercial Equipment designed to ensure that it is in
working order and in a state of good repair. LTS AG will be 

 

 

	 	 	responsible for maintaining
maintenance and calibration records with respect to activities performed on the Commercial
Equipment in accordance with LTS AG’s maintenance documentation system. NuPathe reserves the
right to audit maintenance records and procedures during any regular quality assurance audit.

	4.4	 	Risk of Loss. Risk of loss of or damage to Commercial Equipment shall be borne by
LTS AG at all times while the Commercial Equipment is in LTS AG’s possession or control, at
its facilities, or in transit to LTS AG

5. LTS AG Consideration

	5.1	 	Supply Price. LTS AG has provided a non-binding price indication dated May 19, 2010
(attached as Annex 6) for the supply price for the Commercial Components which is subject to
the assumptions as set forth therein. LTS AG shall as soon as feasible after the completion
of the Installation Activities and the transfer and qualification of the manufacturing
process, provide a first price offer in order to evaluate whether the supply price would still
be consistent with the price indication. In case the first price offer exceeds the price
indication set forth in Annex 6, the Parties shall discuss in good faith possible actions
resulting therefrom.

	5.2	 	Dedicated Use. During the term of the Development Agreement or the Manufacturing
Agreement, the Commercial Equipment shall be used only by, or on behalf of, LTS AG or its
affiliates and only in connection with the manufacture of Commercial Components, clinical
supplies as requested by NuPathe in accordance
with the Development Agreement, for performing the Installation Activities, or in
connection with manufacturing scale—up of the Commercial Components. LTS AG shall keep
reasonable records to account for the use of the Commercial 

 

 

	 	 	Equipment and shall provide
copies of such records to NuPathe upon NuPathe’s request.

6. Other investments and costs

Except as otherwise set forth herein, by this agreement NuPathe does not assume responsibility for
capital investments and costs related to the expansion, preparation and maintenance of the
Facility. Specifically and without limitation, this encompasses all capital investments and costs
related to the construction, purchase, installation, modification, commissioning and validation of
facilities, utilities, process equipment, air handling systems, computer systems, the peripheral
equipment/furnishings required by the operation, and the maintenance of the Facility according to
cGMP and Regulatory Requirements. LTS AG represents, that in the price indication attached as
Annex 6 the aforementioned costs as of the date thereof have been included. The foregoing shall,
however, in no way limit LTS AG or its affiliates in including any of the aforementioned costs in
the supply price in case of changes.

In the event that NuPathe requests that the Facility exceed current cGMP or Regulatory
Requirements, then LTS AG and NuPathe shall discuss, in good faith, coverage of the costs for
completing the requested activities.

7. Confidentiality

	7.1	 	Confidential Information. Except as expressly provided in this Article 7, each Party
shall, during the term of this Agreement and for a period of ten (10) years
thereafter, keep completely confidential and shall not use, put into production, publish
nor otherwise disclose the Confidential Information received from the other Party under
this Agreement, or the Development Agreement. As used herein, 

 

 

	 	 	“Confidential Information”
means the terms of this Agreement as well as all information, including but not limited to
data, know-how, formulas, processes, specifications, designs, financial and organizational
information, mechanical equipment, technical information and/or trade secrets which have
been or may hereafter be disclosed, directly or indirectly by a Party to the other Party,
either orally or in writing, or through inspection as well as samples; except that
Confidential Information shall not include information which the receiving Party can show
by competent proof:

	 	(a)	 	was, at the time of disclosure, in the public domain;
	 
	 	(b)	 	has subsequent to disclosure, become part of the public domain through no
fault, act, omission, or violation by the receiving Party of the confidentiality
obligations hereunder or under the Secrecy Agreement dated May 31, 2006 or the
Development Agreement;
	 
	 	(c)	 	was, at the time of disclosure, in the possession of the receiving Party and
not otherwise acquired, directly or indirectly, from the disclosing Party;
	 
	 	(d)	 	has been developed independently by the receiving Party without access to the
Confidential Information of the disclosing Party; or
	 
	 	(e)	 	has subsequent to disclosure been obtained by the receiving Party from a
third party, provided however, that it was not obtained by said third party, directly
or indirectly, from the disclosing Party under any obligation of confidentiality.

	7.2	 	It is understood that a specific item of the Confidential Information shall not be deemed to
be within the exceptions set forth in Section 7.1 above, if it is merely 

 

 

	 	 	embraced by more
general Confidential Information within one of such exceptions.

	7.3	 	Each receiving Party shall limit access to the Confidential Information from the disclosing
Party to those of its officers, employees, advisors and consultants who need to know such
Confidential Information for the purpose of this Agreement and who will be advised of the
conditions of this Agreement. In case a receiving Party wishes to disclose Confidential
Information to one of its consultants, it may only do so on a need to know basis and provided
that such consultant agrees in writing to be bound to the terms of confidentiality and nonuse
at least as stringent as those set forth in this Article 7.
	 
	7.4	 	Neither Party shall use Confidential Information of the disclosing Party to contest or
challenge any protected rights of, or applications for protection of rights by, the disclosing
Party concerning such Confidential Information.
	 
	7.5	 	Permitted Uses and Disclosures:

	 	(a)	 	Performance of this Agreement. Each Party hereto may use Confidential
Information of the other Party as is reasonably necessary or to perform obligations
hereunder or to exercise rights granted to it hereunder.
	 
	 	(b)	 	Disclosure to Certain Third Parties. NuPathe may disclose Confidential
Information of LTS AG to third parties in connection with sublicenses, strategic
collaborations, equity or debt financing, IPO, merger, acquisition, changes of control
or other similar transactions (“Transactions”), for the sole purposes of
enabling such third parties to conduct such Transactions and/or any diligence in
connection with such Transactions. In the case of Confidential Information 

 

 

	 	 	 	comprising
batch records, manufacturing instructions, details of the manufacturing process,
specifications, supply price, quality audit reports and regulatory filings detailing
manufacturing know-how and LTS AGpatent applications, in each case relating to the
Commercial Equipment and/or the Commercial Components, prior to disclosing such
Confidential Information of LTS AGto a third party as described in this Section 7.5(b),
NuPathe shall first obtain a written confidentiality agreement with such third party
that is reasonable and customary for such Transaction or diligence.

	 	(c)	 	Legal Requirements or Governmental Filings. In addition, each Party may use
and disclose Confidential Information of the other Party to the extent such use or
disclosure is necessary in prosecuting or defending litigation in accordance with this
Agreement, complying with applicable governmental laws or regulations, such as FDA or
SEC regulations, or court order or otherwise submitting information to tax or other
governmental authorities, in submissions to regulatory authorities, as a part of
patent applications filed on inventions made under this Agreement, or as a part of
applications for marketing approval; provided that if a Party is required by law to
make any such disclosure, other than pursuant to a confidentiality agreement, it will
give reasonable advance notice to the other Party of such disclosure and, except to
the extent inappropriate in the case of patent applications or the like, will use
reasonable commercial efforts to secure confidential treatment of such information.

	7.6	 	Expiration or Termination of this Agreement. Upon any expiration or termination of this
Agreement, each Party shall promptly return all Confidential Information 

 

 

	 	 	of the other Party,
provided however, that each Party may retain such Confidential Information as reasonably
necessary to exercise rights hereunder or perform obligations hereunder that survive such
expiration or termination, and each Party may retain one copy of the Confidential Information
thereof in its legal files solely for archival purposes.

8. Term/Survival

	8.1	 	Term. This Agreement shall commence on the Effective Date and continue in full force
and effect until the later of the completion of all Installation Activities or the execution
of the Manufacturing Agreement.
	 
	8.2	 	Survival. Notwithstanding the termination or expiration of this Agreement for any
reason, NuPathe shall be liable for the payment of any non-cancellable obligations of LTS AG
to third parties as of the date such termination or expiration becomes effective. In addition,
any terms of this Agreement which by their nature extend beyond its performance, expiration or
termination (including, without limitation, Sections 4 through 7, this Section 8.3 and
Sections 9.2, 9.5, 9.6 and 9.9) shall survive any termination or expiration of this Agreement,
however caused.

9. Miscellaneous

	9.1	 	Additional provisions. Notwithstanding Section 9.11, in addition to the other terms
and conditions contained herein, the following provisions of the Development Agreement shall
be deemed terms and conditions of this Agreement: Section 11.04, 11.05, 12.01, 14.01, 14.04
and 14.05, provided that, wherein such provisions reference is made to “Product” it
shall be deemed to have the same meaning as
referring to “NuPathe Patch” as defined
herein.

 

 

	9.2	 	Dispute Resolution.

	 	(a)	 	Disputes. The Parties shall attempt in good faith to resolve promptly any
dispute arising out of or relating to this Agreement by negotiation. If the matter
cannot be resolved in the normal course of business, either Party shall give to the
other Party written notice of any such dispute not resolved, after which the dispute
shall be referred to the principal executive officers of both Parties or their
designees who shall likewise attempt to resolve the dispute. If the dispute has not
been resolved by negotiations within ten (10) days of such written notice, each Party
may have the dispute mediated in accordance with Section 9.1(b) below.
	 
	 	(b)	 	Mediation and Arbitration. The Parties shall then attempt in good faith to
resolve any significant controversy, claim, or dispute arising out of or relating to
this Agreement or any significant breach thereof through mediation with a mutually
agreed mediator. If the mediation of such dispute does not commence within thirty
(30) days (or such other period of time mutually agreed upon by the Parties) of the
receipt of a written request for such mediation by the other Party, or if the dispute
is not resolved within thirty (30) days (or such other period of time mutually agreed
upon by the Parties) of commencing such mediation, or if the Party against which a
claim has been asserted refuses to attend such mediation, or the Parties are unable to
agree upon a mediator, then either Party may proceed to arbitration under the Rules of
Arbitration of the International Chamber of Commerce. The arbitration shall be conducted in
English. The award of arbitration shall be final and binding upon 

 

 

	 	 	 	both Parties. It is
understood that the Parties agree that any disputes shall be referred to an arbitration
panel as set forth above and shall not be referred to a regular court.

	 	(c)	 	Restraining Order. The dispute resolution procedures set forth herein shall
not limit a court from granting a temporary restraining order or a preliminary
injunction in order to preserve the status quo of the Parties pending arbitration or
to protect a Party’s trademark or confidential or proprietary information. Further,
the arbitrator shall have power to enter such orders by way of interim award, and such
orders shall be enforceable in court.
	 
	 	(d)	 	THE UNDERSIGNED PARTIES ACKNOWLEDGE THAT THE RIGHT TO TRIAL BY JURY IS A
CONSTITUTIONAL ONE, BUT THAT IT MAY BE WAIVED AND AFTER CONSULTING WITH COUNSEL,
KNOWINGLY AND VOLUNTARILY WAIVE ANY RIGHT TO TRIAL BY JURY IN THE EVENT OF LITIGATION
REGARDING THE PERFORMANCE OR ENFORCEMENT OF, OR IN ANY WAY RELATED TO, THIS AGREEMENT
AND ANY AGREEMENT CONNECTED THERETO.

	9.3	 	Governing Law. This Agreement shall be governed by, and construed and interpreted in
accordance with, the laws of New Jersey, United States of America (including U.S. federal
law), without regard to conflict of laws principles.
	 
	9.4	 	Assignment. Neither Party shall have the right to assign this Agreement or its rights
hereunder without a prior written consent of the other Party; provided,
however, that no consent is required in connection with a sale or transfer of all or

 

 

	 	 	substantially all of the assets, securities or business of the assigning Party whether by
sale, merger, operation of law, reincorporation or otherwise.
The Parties agree that LTS AG may engage LTS Corp. in the performance of its obligations
hereunder provided that LTS Corp. agrees to comply with the terms of this Agreement and
provided further that such engagement shall not relieve LTS AG of its obligations or
liability under this Agreement.

	9.5	 	Independent Contractors. The relationship of LTS AG and NuPathe established by this
Agreement is that of independent contractors. Nothing in this Agreement shall be construed to
create any other relationship between LTS AG and NuPathe. Neither Party shall have any right,
power or authority to assume, create or incur any expense, liability or obligation, express or
implied, on behalf of the other Parties.
	 
	9.6	 	English Language. This Agreement is in the English language only, which language
shall be controlling in all respects, and all versions of this Agreement in any other language
shall not be binding on the Parties hereto. All communications and notices to be made or given
pursuant to this Agreement shall be in the English language.
	 
	9.7	 	Notices. Any notice or other communication required by this Agreement shall be made
in writing and given by prepaid, first class, certified mail, return receipt requested, and
shall be deemed to have been given on the date received by the addressee at the following
address or such other address as may from time to time be designated to the other Party in
writing:

 

 

	 	 	 	 	 

	 
	 	If to LTS AG:	 	LTS LOHMANN Therapie-Systeme AG,
	 
	 	 	 	 
	 
	 	 	 	Lohmannstr. 2,
	 
	 	 	 	 
	 
	 	 	 	56626 Andernach,
	 
	 	 	 	 
	 
	 	 	 	Germany
	 
	 	 	 	 
	 
	 	 	 	Attn:  General Counsel
	 
	 	 	 	 
	 
	 	If to NuPathe:	 	NuPathe Inc.
	 
	 	 	 	 
	 
	 	 	 	227 Washington Street, Suite 200
	 
	 	 	 	 
	 
	 	 	 	Conshohocken, PA  19428
	 
	 	 	 	 
	 
	 	 	 	U.S.A.
	 
	 	 	 	 
	 
	 	 	 	Attn:  General Counsel

	9.8	 	Currency. Except as otherwise set forth herein, any payments to be made by NuPathe
hereunder shall be made in Euros.
	 
	9.9	 	No Waiver. A waiver, express or implied, by either LTS AG or NuPathe of any right
under this Agreement or of any failure to perform or breach hereof by the other Party hereto
shall not constitute or be deemed to be a waiver of any other right hereunder or of any other
failure to perform or breach hereof by such other Party, whether of a similar or dissimilar
nature thereto.
	 
	9.10	 	Severability. If any provision of this Agreement shall be found by a court to be
void, invalid or unenforceable, the same shall be reformed to comply with applicable law or
stricken if not so conformable, so as not to affect the validity or enforceability of the
remainder of this Agreement, and the remainder of this Agreement shall remain in full force
and effect.

 

 

	9.11	 	Entire Agreement. Except as set forth in Section 9.1, this Agreement, together with
any and Exhibits, constitute the entire understanding and agreement between the Parties as of
the Effective Date with respect to the subject matter hereof and supersedes any and all prior
and contemporaneous negotiations, representations, agreements, and understandings, written or
oral, that the Parties may have reached with respect to the subject matter hereof. No
agreements altering or supplementing the terms hereof may be made except by means of a written
document signed by the duly authorized representatives of each of the Parties hereto.
	 
	9.12	 	Counterparts. This Agreement may be executed in counterparts, each of which shall be
deemed an original, but both of which together shall constitute one and the same instrument.

     IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute
this Agreement as of the Effective Date.

	 	 	 	 	 	 	 	 	 

	LTS LOHMANN Therapie-Systeme AG	 	 	 	NuPathe Inc.
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ ppa Ulrich Sielaff /s/ ppa Klaudia Haczkiewicz
	 	 	 	By:
	 	/s/ Keith A. Goldan
	 

	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Name:

	 	Ulrich Sielaff Klaudia Haczkiewicz
	 	 	 	Name:
	 	Keith A. Goldan
	 
	 	 	 	 	 	 	 	 
	Title:

	 	General Counsel Head of BD
	 	 	 	Title:
	 	Vice President & CFO

 

 

ANNEX 1 COMMERCIAL EQUIPMENT

			
	[**]	 	 [A
total of 13 pages, including the remainder of this page, have
been redacted and filed separately with the Securities and Exchange
Commission.]

 

			
	**	 	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.

 

 

ANNEX 2 PROJECT PLAN

[**]

 

			
	**	 	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.

 

 

ANNEX 3

PERFORMANCE REQUIRMENTS

Quantities of Commercial Components for each production line:

	 	 	 

	E-Patch Line

	 	[**] units per year
	Drug Product Line

	 	[**] units per year

 

			
	**	 	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.

 

 

ANNEX 4 PAYMENT SCHEDULE

SUMATRIPTAN IONTOPHORETIC SYSTEM — CAPEX REQUIREMENTS

PAYMENT SCHEDULE / COSTS AND EXPENSES

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[**]	 	 	 	 	 	 	€	 	 	M-1	 	 	M-2	 	 	M-3	 	 	M-4	 	 	M-5	 	 	M-6	 	 	M-7	 	 	M-8	 	 	M-9	 	 	M-10	 	 	M-11	 	 	M-12	 	 	M-13	 	 	M-14	 
	[**]
	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[**]
	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 
	[**]
	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[**]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	 	 	 	 	 	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	 	 	 	 	 	 
	Total
	 	 	 	 	 	 	5,370,000	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Monthly total costs
and expenses
	 	 	 	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 

     [**]

 

			
	**	 	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.

 

 

ANNEX 5

Depreciation Schedule and Book Value Determination

(Linear
depreciation over a period of five (5) years from the date of completion of the
Installation Activities)

 

 

ANNEX 6 Price Indication

			
	[**]	 	[A total of three pages, including the
remainder of this page, have been redacted and filed separately with the Securities and Exchange Commission.]

 

			
	**	 	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.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00176-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00176-of-00352.parquet"}]]