ASSET PURCHASE AND LICENSE AGREEMENT BY AND BETWEEN NUPATHE INC., AND TRAVANTI PHARMA INC.
Exhibit 10.3
Execution Copy
BY AND BETWEEN
AND
XXXXXXXX PHARMA INC.
TABLE OF CONTENTS
| Page | ||||
Article I DEFINITIONS |
1 | |||
Section 1.1 Definitions |
1 | |||
Article II PURCHASE AND SALE |
6 | |||
Section 2.1 Purchase and Sale of Assets |
6 | |||
Section 2.2 Assumed Liabilities |
6 | |||
Section 2.3 Effective Date |
6 | |||
Article III FINANCIAL |
6 | |||
Section 3.1 Purchase Price |
6 | |||
Article IV GRANTS OF LICENSE AND LICENSE TERMS |
6 | |||
Section 4.1 License to NuPathe |
6 | |||
Section 4.2 License to Xxxxxxxx |
7 | |||
Section 4.3 Other Intellectual Property under the WEDD Technology License |
7 | |||
Section 4.4 Infringement of Patents |
8 | |||
Section 4.5 Third Party Claims |
8 | |||
Article V REPRESENTATIONS AND WARRANTIES OF XXXXXXXX |
9 | |||
Section 5.1 Organization; Standing and Power |
9 | |||
Section 5.2 Authority; Binding Agreements |
9 | |||
Section 5.3 Compliance; Conflicts; Governmental Consents |
9 | |||
Section 5.4 Good Title; Sufficiency of Assets |
10 | |||
Section 5.5 Intellectual Property |
10 | |||
Section 5.6 Litigation |
11 | |||
Section 5.7 Adverse Information |
11 | |||
Section 5.8 Taxes |
11 | |||
Section 5.9 Regulatory Matters |
11 | |||
Section 5.10 Adequate Consideration |
12 | |||
Section 5.11 Indemnity By Xxxxxxxx |
12 | |||
Article VI REPRESENTATIONS, WARRANTIES AND INDEMNITY OF NUPATHE |
12 | |||
Section 6.1 Organization; Standing and Power |
12 | |||
Section 6.2 Authority; Binding Agreements |
12 | |||
Section 6.3 Conflicts; Consents |
13 | |||
Section 6.4 Indemnity By NuPathe |
13 | |||
Article VII ADDITIONAL MATTERS |
13 | |||
Section 7.1 Certain Tax Matters |
13 | |||
Section 7.2 Cooperation in Anti-Migraine Patent Maintenance |
14 | |||
Section 7.3 Expenses |
14 | |||
Section 7.4 Further Assurances |
14 | |||
TABLE OF CONTENTS
| Page | ||||
Article VIII EFFECTIVE DATE DELIVERABLES |
14 | |||
Section 8.1 Deliveries of Xxxxxxxx |
14 | |||
Section 8.2 Deliveries of NuPathe |
14 | |||
Article IX MISCELLANEOUS |
15 | |||
Section 9.1 Notices |
15 | |||
Section 9.2 Waiver |
15 | |||
Section 9.3 Entire Agreement; Amendment |
15 | |||
Section 9.4 Assignment |
16 | |||
Section 9.5 Severability |
16 | |||
Section 9.6 Section Headings; Construction |
16 | |||
Section 9.7 Governing Law; Consent to Jurisdiction and Venue |
16 | |||
Section 9.8 Counterparts |
16 | |||
Section 9.9 Time of Essence |
17 | |||
Section 9.10 No Third Party Beneficiaries |
17 | |||
Section 9.11 Confidentiality |
17 | |||
EXHIBITS TO ASSET PURCHASE AGREEMENT
Exhibit 1
|
Xxxxxxxx Patents | |
Exhibit 2
|
Form of Patent Assignment Agreement |
Asset Purchase and License Agreement (this “Agreement”), dated as of July 8, 2008, by and
between Xxxxxxxx Pharma Inc., a Minnesota corporation with a principal place of business at 0000
Xxxxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx Xxxxxxx, XX 00000 (“Xxxxxxxx”), and NuPathe Inc., a Delaware
corporation with a principal place of business at 000 Xxxxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxxxxx,
XX 00000 (“NuPathe”).
RECITALS
WHEREAS, subject to the terms and conditions of this Agreement, Xxxxxxxx desires to transfer
to NuPathe, and NuPathe desires to acquire from Xxxxxxxx the Purchased Assets;
WHEREAS, pursuant to this Agreement and that certain Patent Assignment Agreement, dated as of
the date hereof (the “Patent Assignment”), by and between NuPathe and Xxxxxxxx, Xxxxxxxx is
assigning the Anti-Migraine Patent to NuPathe;
WHEREAS, NuPathe upon the Effective Date shall license to Xxxxxxxx certain rights under the
Anti-Migraine Patent outside the Field;
WHEREAS,
NuPathe will continue to license the WEDD® Technology from Xxxxxxxx under the terms
set forth herein, and grant to Xxxxxxxx a license to utilize certain NuPathe Intellectual Property
outside of the Field; and
WHEREAS, NuPathe and Xxxxxxxx intend for this Agreement to supersede the License Agreement and
any amendments thereto;
NOW, THEREFORE, in consideration of the mutual benefits to be derived from this Agreement and
of the representations, warranties, conditions, agreements and promises contained herein and other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto, intending to be legally bound, hereby agree as follows:
ARTICLE I
DEFINITIONS
DEFINITIONS
Section 1.1 Definitions. The capitalized terms used in this Agreement have the respective
meanings ascribed to them as follows:
“Act” shall mean the Federal Food, Drug and Cosmetic Act, as amended from time to time.
“Action” shall mean any claim, action, suit, arbitration, inquiry, audit, proceeding or
investigation by or before or otherwise involving, any Governmental Authority.
“Affiliate” shall mean, with references to any Person, any other Person directly or indirectly
controlling, controlled or under common control with such Person, and “control” shall
mean the power to direct the management and policies of a Person, whether through the
ownership of voting securities, by contract or otherwise.
“Agreement” shall have the meaning set forth in the preamble hereof.
“Anti-Migraine Patent” shall mean that certain patent application No. PCT/US07/09000
(WO/2007/120747) entitled “Transdermal Methods and Systems for the Delivery of Anti-migraine
Compounds Related Applications,” filed on April 12, 2007, and all documentation filed in support
thereof, including any priority applications.
“Applicable Laws” shall mean all laws, treaties, ordinances, judgments, decrees, directives,
injunctions, orders of any court, arbitrator or governmental agency or authority, rules,
regulations interpretations, and authorizations of any international, national, regional, local or
other governmental body, agency, authority, court or Person having jurisdiction over or related to
the registration, manufacture and sale of the Products as may be in effect from time to time.
“Books and Records” shall mean all books, records, files (including data files) and documents
(including correspondence) and, to the extent not originals, true and complete copies of all files
relating to the filing, prosecution, issuance, maintenance, enforcement or defense of the
Anti-Migraine Patent in all forms, including electronic, in which they are stored or maintained,
and all data and information included or referenced therein, in each case that are licensed, owned
or controlled by or otherwise in the possession of Xxxxxxxx or any of its Affiliates, as
applicable.
“Consent” shall mean any consent, authorization, permit, certificate, license or approval of,
exemption by, or filing or registration with, any Governmental Agency or other Person.
“Control” including its various tenses and derivatives (such as “Controlled” and
“Controlling”) shall mean possession of the right, whether directly or indirectly, and whether by
ownership, license or otherwise, to assign or grant a license, sublicense or other right to or
under the Xxxxxxxx Intellectual Property or under the NuPathe Intellectual Property, as applicable.
“Dollars” or “$” shall mean United States dollars.
“Effective Date” shall have the meaning set forth in Section 2.3.
“Exploit” or “Exploitation” shall mean to make, have made, import, use, sell, offer for sale,
or otherwise dispose of the Products, including all discovery, research, development, registration,
modification, enhancement, improvement, manufacture, storage, formulation, optimization,
importation, exportation, transportation, distribution, commercialization, promotion and marketing
activities related thereto.
“FDA” shall mean the Food and Drug Administration in the United States, and any successor
thereto.
“Field” shall mean the development and commercialization of compounds, drugs and/or medical
devices, including combinations thereof, for acute, chronic and prophylactic treatment, or
prevention, palliation or diagnosis of migraines, including, without limitation, familiar
hemiplegic migraines, chronic paroxysmal headaches, cluster headaches, migraine headaches
(with and without aura), basilar migraines, and atypical headaches accompanied by autonomic
symptoms, or for any condition defined as a migraine in the International Classification of
Migraine by the International Headache Society.
“Governmental Authority” shall mean any supra-national, federal, state, local or foreign
government, legislature, governmental or administrative agency, department, commission, bureau,
board, instrumentality, self-regulatory association or authority, court or other authority of
tribunal of competent jurisdiction (including any arbitration or other alternative dispute forum),
or any other governmental authority or instrumentality anywhere in the world.
“Intellectual Property” shall mean all intellectual property rights, whether registered or
unregistered, including (a) Patents, (b) Trademarks, (c) other intellectual property rights,
including confidential information, trade secrets, and similar proprietary rights in confidential
inventions, discoveries, analytic models, improvements, processes, techniques, devices, methods,
patterns, formulations and specifications, (d) all completed or pending registrations, renewals or
applications for registration or renewal of any of the foregoing, and (e) copies and tangible
embodiments of any of the foregoing (in whatever form or media).
“License Agreement” shall mean the License Agreement, by and between Xxxxxxxx and NuPathe,
dated as of July 20, 2005, as amended by the Addendum to the License Agreement, dated as of March
1, 2007.
“Lien” shall mean any lien (statutory or otherwise), security interest, pledge, hypothecation,
mortgage, assessment, lease, claim, levy, license, defect in title, charge, or any other third
party right, license or property interest of any kind, or any conditional sale or other title
retention agreement, right of first option, right of first refusal or similar restriction, any
covenant not to xxx, or any restriction on use, transfer, receipt of income or exercise of any
other attribute of ownership, or any agreement to give any of the foregoing in the future or
similar encumbrance of any kind or nature whatsoever.
“NDA” shall mean a New Drug Application for any product requesting permission to place the
product on the market in accordance with the Act, together with all supplements or amendments filed
with respect thereto pursuant to the requirements of the Act, including all documents, data and
other information concerning the product that are reasonably necessary for the FDA approval to
market the product in the United States.
“NuPathe Intellectual Property” shall have the meaning set forth in Section 4.2(b).
“Order” shall mean any writ, judgment, decree, injunction or similar order, including consent
orders, of any Governmental Authority (in each such case whether preliminary or final).
“Patents” shall mean (a) all national, regional and international patents and patent applications,
including provisional patent applications; (b) all patent applications filed either from such
patents, patent applications or provisional applications or from an application claiming priority
from either of these, including divisionals, continuations, continuations-in-part, substitutions,
provisionals, converted provisionals, and continued prosecution applications; (c) any and all
patents that have issued or in the future issue from the foregoing patent applications
described in clauses (a) and (b); (d) any and all extensions or restorations by existing or future
extension or restoration mechanisms, including revalidations, reissues, re-examinations and
extensions (including any supplementary protection certificates and the like) of the foregoing
patents or patent applications described in clauses (a), (b) and (c); and (e) any similar rights,
including so-called pipeline protection, or any importation, revalidation, confirmation or
introduction patent or registration patent or patent of additions to any such foregoing patent
applications and patents.
“Person” shall mean a person, partnership, firm, enterprise, association, joint venture,
corporation, limited liability company, or any other organization or entity.
“Products” shall mean any and all pharmaceutical products related to, derived from or
supported by the Anti-Migraine Patent and/or the WEDD® Technology.
“Purchased Assets” shall mean the Anti-Migraine Patent and all Books and Records related
thereto.
“Regulatory Approval” shall mean, with respect to a country in the Territory, any and all
approvals, licenses, registrations or authorizations of any Governmental Authority necessary or
useful for the Exploitation of the Products in the Field in such country.
“Regulatory Documentation” shall mean any and all applications, registrations, licenses,
authorizations and approvals prepared for submission to a Governmental Authority with a view to the
granting of any Regulatory Approval, and any correspondence to or with the FDA or any other
Governmental Authority with respect to the Products in the Field, as applicable, including, for
clarity, original and, if available, electronic copies of all (a) tests and data generated
therefrom, (b) all correspondence and other documentation related to communications to or from
Governmental Authorities, and (c) all other supporting documentation and materials that would be
necessary or useful to obtain or maintain Regulatory Approvals in connection with the Products in
the Field.
“Related Documents” shall mean, other than this Agreement, the Patent Assignment and all other
agreements, certificates and documents signed and delivered by either party in connection with this
Agreement.
“Settlement Agreement” shall mean the Settlement Agreement by and between Xxxxxxxx and
NuPathe, dated as of March 1, 2007.
“Tax” or “Taxes” shall mean any and all federal, state, local, or foreign net or gross income,
gross receipts, net proceeds, sales, use, ad valorem, value added, franchise, bank shares,
withholding, payroll, employment, excise, property, deed, stamp, alternative or add-on minimum,
environmental, profits, windfall profits, transaction, license, lease, service, service use,
occupation, severance, energy, unemployment, social security, workers’ compensation, capital,
premium, and other taxes, assessments, customs, duties, fees, levies, or other governmental charges
of any nature whatsoever, whether disputed or not, together with any interest, penalties, additions
to tax, or additional amounts with respect thereto and including any liability for the payment of
the foregoing obligations of another Person as a result of (a) being or
having been a member of an affiliated, consolidated, combined, unitary or aggregate group of
corporations; (b) being or having been a party to any tax sharing agreement or any express or
implied obligation to indemnify any Person; and (c) being or having been a transferee,
successor, or otherwise assuming the obligations of another Person to pay the foregoing amounts.
“Tax Returns” shall mean any return, declaration, report, claim for refund, or information
return or statement relating to Taxes, including any schedule or attachment thereto, and including
any amendment thereof.
“Territory” shall mean each country throughout the world.
“Trademark” shall mean (a) any word, name, symbol, color, designation or device or any
combination thereof, including any trademark, trade dress, brand xxxx, trade name, brand name, logo
or business symbol, (b) all registrations and applications for any of the foregoing, and (c) all
rights and priorities connected with the foregoing afforded under Applicable Law.
“Xxxxxxxx Intellectual Property” shall have the meaning set forth in Section 5.5(b).
“Xxxxxxxx Know-How” shall mean any and all information and any materials in existence as of
the date of this Agreement, including, without limitation, inventions, formulations, processes,
techniques, formulas, biological, chemical, assay control and manufacturing data, methods,
software, equipment designs, know-how, and trade secrets, patentable or otherwise, tangible or
intangible, that are Controlled by Xxxxxxxx, and that: (i) arise from practicing art described by
Xxxxxxxx Patents or the Anti-Migraine Patent; and (ii) are necessary or useful in the development,
commercialization, manufacture, use, sale or import of Products in the Field, or any improvements
thereto in existence on the date hereof (to the extent that such information and inventions are not
generally known).
“Xxxxxxxx’x Knowledge” (and similar phrases) shall mean the actual knowledge of any officer,
director, patent attorney or employee of Xxxxxxxx having primary responsibility for such matter,
without independent investigation or inquiry.
“Xxxxxxxx Patents” shall mean any currently existing or future Patents Controlled by Xxxxxxxx
necessary or required to develop make, have made, use, sell, offer to sell or import the Products
in the Field, including but not limited to, the Patents set forth on Exhibit 1 attached
hereto and the WEDD Technology, and any and all continuations, continuations-in-part, additions,
divisions, renewals, extensions, re-examinations and reissues thereof and any and all foreign
counterparts of the foregoing.
“Valid Claim” shall mean a claim of an issued and unexpired Patent which can be reasonably
asserted against a party manufacturing, using, offering for sale, selling or importing a Product
absent a license and whose validity or enforceability has not been adversely affected by any of the
following: (i) lapse, revocation, or abandonment, (ii) a determination by a court or other
Governmental Agency of competent jurisdiction, which is unappealable or has not been appealed
within the time allowed for appeal, that the patent is unenforceable or invalid, and/or (iii) a
disclaimer or admission of invalidity or unenforceability through reissue, re-examination,
opposition, nullity action or invalidation suit response, disclaimer or otherwise.
“WEDD® Technology” shall mean that wearable electronic disposable drug delivery technology,
covered by a Valid Claim under Xxxxxxxx Patents existing as of the Effective Date.
ARTICLE II
PURCHASE AND SALE
PURCHASE AND SALE
Section 2.1 Purchase and Sale of Assets. Pursuant to the terms and subject to the conditions
of this Agreement, in consideration for the entering into the Patent Assignment and the payment of
the fees set forth in the Patent Assignment, Xxxxxxxx hereby sells, conveys, delivers, transfers
and assigns to NuPathe, free and clear of all Liens, all of Xxxxxxxx’x (and, as applicable, its
Affiliates’) right, title and interest in, to and under the Purchased Assets (and, as applicable,
its Affiliates).
Section 2.2 Assumed Liabilities. NuPathe expressly does not assume and shall not become
liable to pay, perform or discharge, any liability, obligation or commitment whatsoever of Xxxxxxxx
relating to the Purchased Assets.
Section 2.3 Effective Date. Pursuant to the terms and subject to the conditions of this
Agreement, the signing and closing of the transaction contemplated by this Agreement shall take
place at the offices of Xxxxxx, Xxxxx & Bockius LLP, 000 Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx, at
10:00 a.m. local time on the date hereof, or such time and place on which the parties agree (the
“Effective Date”).
ARTICLE III
FINANCIAL
FINANCIAL
Section 3.1 Purchase Price. Subject to the terms and conditions set forth herein and in the
Patent Assignment, in consideration of the sale, assignment and delivery of the Purchased Assets,
NuPathe shall pay to Xxxxxxxx the sum of Five Million Five Hundred Thousand Dollars ($5,500,000)
(the “Purchase Price”) on the Effective Date by wire transfer in immediately available funds in
accordance with Xxxxxxxx’x instructions.
ARTICLE IV
GRANTS OF LICENSE AND LICENSE TERMS
GRANTS OF LICENSE AND LICENSE TERMS
Section 4.1 License to NuPathe.
(a) WEDD® Technology. Subject to the terms and conditions contained in this Agreement,
Xxxxxxxx grants to NuPathe a sole and exclusive, even as to Xxxxxxxx, perpetual, worldwide,
royalty-free license, with right to grant sublicenses, under Xxxxxxxx Patents and Xxxxxxxx
Know-How, to develop, make, have made, use, offer to sell, sell, have sold and import Products in
the Field in the Territory. NuPathe shall not sell Products under the WEDD® Technology outside the
Field.
(b) Sublicensing. NuPathe acknowledges that the grant of a sublicense under this Section 4.1
shall not relieve NuPathe from its obligations under this Agreement, and NuPathe shall be fully
responsible for the compliance of its sublicensees with the terms and conditions of this
Agreement.
Section 4.2 License to Xxxxxxxx.
(a) Anti-Migraine Patent for Use Outside the Field. Subject to the terms and conditions
contained in this Agreement, NuPathe grants to Xxxxxxxx a perpetual, non-exclusive, worldwide,
royalty-free license, with right to grant sublicenses, under the Anti-Migraine Patent, to develop,
make, have made, use, offer to sell, sell, have sold, and import Products outside the Field in the
Territory.
(b) WEDD® Technology. Subject to the terms and conditions contained in this Agreement,
NuPathe grants to Xxxxxxxx a perpetual, non-exclusive, worldwide, royalty free license under
NuPathe Intellectual Property to develop, make, have made, use, offer to sell, sell, have sold, and
import Products using or based on the WEDD® Technology outside the Field. “NuPathe Intellectual
Property” shall mean any present or future improvements claimed in a Patent to WEDD® Technology
(i.e., to the extent that practicing such improvements without a license would infringe a Xxxxxxxx
Patent), which are Controlled by NuPathe.
(c) No Sales of Products in the Field. Xxxxxxxx shall not sell Products under the
Anti-Migraine Patent or the WEDD® Technology in the Field.
(d) Sublicensing. Xxxxxxxx acknowledges that the grant of a sublicense under this Section 4.2
shall not relieve Xxxxxxxx from its obligations under this Agreement, and Xxxxxxxx shall be fully
responsible for the compliance of its sublicensees with the terms and conditions of this Agreement.
| Section 4.3 Other Intellectual Property under the WEDD® Technology License. |
(a) Trademarks. NuPathe will have the right, in its sole discretion and at its
expense, to select and register those Trademarks it wishes to employ in connection with the sale of
the Products throughout the Territory, and NuPathe will have legal and equitable ownership of the
entire right, title and interest in and to the Trademarks and registrations NuPathe elects to use;
provided, however, that NuPathe shall not use Xxxxxxxx’x name nor any of Xxxxxxxx’x Trademarks
without prior written consent, except that NuPathe may state that it is licensed by Xxxxxxxx under
one or more of the Xxxxxxxx Patents as authorized by this Agreement or as required by Applicable
Laws.
(b) Ownership of Data. Each party will own all information and results related to
such party’s own research and development activities for Products it develops, manufactures or
sells in accordance with the terms and conditions of this Agreement, including, without limitation,
any and all research data, pharmacology data, preclinical data, clinical data, and information,
obtained or generated and documentation submitted, or required to be submitted, in association with
regulatory filings for such Products (including any Drug Master Files, Chemistry, Manufacturing and
Control data, or similar documentation).
(c) Ownership of Regulatory Filings. All INDs, NDAs and other regulatory filings made
or filed by NuPathe with respect to any Products in the Field will be in the name of, and be owned
solely by, NuPathe or its third party licensee, at the discretion of NuPathe.
(d) Patent Prosecution. NuPathe will be responsible, at its own cost, for preparing,
prosecuting and maintaining the NuPathe Intellectual Property and the Anti-Migraine Patent.
Xxxxxxxx shall, at its own cost, prepare, prosecute and maintain Xxxxxxxx Patents during the
term of this Agreement
(e) Abandonment. In the event Xxxxxxxx wishes to abandon any Xxxxxxxx Patents,
Xxxxxxxx will offer to assign, free of charge, any such Patent or Patents to NuPathe prior to
effectuating the abandonment. Should NuPathe elect to become an assignee of such Patents, NuPathe
will bear the costs connected to any assignment hereunder.
Section 4.4 Infringement of Patents. If either party has knowledge of any infringement of the
Xxxxxxxx Know-How or Xxxxxxxx Patents that could negatively impact either party’s exercise of the
license rights granted under Article 4 of this Agreement, the party having such knowledge shall
promptly inform the other of such infringement. The parties will thereafter discuss what action
should be taken, including whether any legal proceeding should be instituted. If the parties
mutually agree on the course of action to be taken in respect of any such infringement, they will
jointly select counsel and equally share any expenses. Any settlement or recovery shall be
distributed in the following order: (i) pro rata to each party for reimbursement of expenses
related to such claim, including but not limited to attorneys’ fees and expenses associated with
the legal proceedings; (ii) to the licensee of such Intellectual Property for any damages related
to the license rights granted to such party; and (iii) to the extent any settlement or recovery
remains, to each party equally. If either party determines to take action, but the other party
does not desire to do so, the first party may take action at its own expense and through counsel of
its own choice, and any settlement or recovery will in such case belong solely to the party taking
action. If one party institutes and carries on a legal proceeding to enforce Xxxxxxxx Patents
against an alleged infringing party, the other party will fully cooperate with and supply all
assistance reasonably requested by the party instituting and carrying on such proceeding; provided,
however, that no settlement or consent judgment or other voluntary final disposition of any such
action may be entered into without the written 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
restrict the claims in or admit any invalidity of any Intellectual Property Rights or otherwise
adversely affect the rights of the other party to this Agreement.
| Section 4.5 Third Party Claims. |
(i) Notice. In the event that a party becomes aware of any claim filed with a
Governmental Authority that the performance of this Agreement infringes the intellectual property
rights of a third party, such party will promptly notify the other party.
(ii) Third Party License. If NuPathe would be prevented from using, selling or
importing Product in any country of the Territory on grounds that by doing so NuPathe would
infringe a Valid Claim of a Patent held by a third party in said country (the “Blocking Third Party
IP”), NuPathe will notify Xxxxxxxx and give Xxxxxxxx a reasonable opportunity to oppose or
otherwise resolve such claim. In the event that Xxxxxxxx elects not to oppose the claim or does
not successfully obtain any necessary license, NuPathe will have the right to negotiate directly
with such third party for a license under the Blocking Third Party IP.
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF XXXXXXXX
REPRESENTATIONS AND WARRANTIES OF XXXXXXXX
Xxxxxxxx represents and warrants to NuPathe, as of the Effective Date, as follows, with each
such representation and warranty subject only to such exceptions, if any, as are set forth in the
particular disclosure schedule numbered and captioned to correspond to, and referenced in, such
representation or warranty:
Section 5.1 Organization, Standing and Power. Xxxxxxxx is a corporation duly organized,
validly existing and in good standing under the laws of the Minnesota. Xxxxxxxx is duly qualified
to do business and is in good standing in each jurisdiction in which such qualification is
necessary.
Section 5.2 Authority; Binding Agreements. The execution and delivery by Xxxxxxxx of this
Agreement and the Related Documents to which it is or will become a party and the consummation of
the transaction contemplated hereby have been duly and validly authorized by all necessary action
on the part of Xxxxxxxx. Xxxxxxxx has all requisite power and authority to enter into this
Agreement and the Related Documents to which it is or will become a party and to consummate the
transaction contemplated hereby, and this Agreement and such Related Documents have been, or upon
execution and delivery thereof will be, duly executed and delivered by Xxxxxxxx. No shareholder or
other equity holder approval is required on behalf of Xxxxxxxx for the execution, delivery or
performance of this Agreement and such Related Documents. This Agreement and the Related Documents
to which Xxxxxxxx is or will become a party are, or upon execution and delivery by Xxxxxxxx thereof
will be, the valid and binding obligations of Xxxxxxxx, enforceable against Xxxxxxxx in accordance
with their respective terms.
Section 5.3 Compliance; Conflicts; Governmental Consents. The execution and delivery by
Xxxxxxxx of this Agreement and the Related Documents to which it is or will become a party, the
consummation of the transaction contemplated hereby and compliance by Xxxxxxxx with any of the
provisions hereof and thereof do not and will not:
(a) conflict with or result in a breach of the certificate of incorporation, bylaws or other
constitutive or organizational documents of Xxxxxxxx;
(b) violate any Applicable Law with respect to Xxxxxxxx or the Purchased Assets;
(c) result in the creation or imposition of any Lien upon the Purchased Assets; or
(d) require any material notice to, filing with, authorization of, exemption by, or Consent
of, any Person, including any Governmental Authority, including any foreign Governmental Authority,
for Xxxxxxxx to transfer the Purchased Assets to NuPathe and otherwise consummate the transaction
contemplated hereunder.
Section 5.4 Good Title; Sufficiency of Assets. Xxxxxxxx (i) has good and marketable title to
the Purchased Assets free and clear of all Liens, and has the complete and unrestricted power and
unqualified right to sell, convey, deliver, transfer and assign to NuPathe, as applicable, the
Purchased Assets; and (ii) to Xxxxxxxx’x Knowledge, there are no adverse claims of ownership to the
Purchased Assets and Xxxxxxxx has not received notice that any Person has
asserted a claim of ownership or right of possession or use in or to any of the Purchased
Assets. On the Effective Date, NuPathe will acquire from Xxxxxxxx, good and marketable title to
the Purchased Assets, free and clear of all Liens.
Section 5.5 Intellectual Property.
(a) Xxxxxxxx owns all right, title and interest in and to, and has the unrestricted right to
assign to NuPathe, all right, title and interest in, to and under the Purchased Assets, in each
case to Xxxxxxxx’x Knowledge free of any rights or claims of any Person or any other Liens, and
without payment by either party of any royalties, license fees or other amounts to any other
Person.
(b) Xxxxxxxx has valid rights to grant the license rights to the Xxxxxxxx Intellectual
Property to NuPathe as provided herein. The “Xxxxxxxx Intellectual Property” means the Xxxxxxxx
Patents and/or other Intellectual Property Controlled by, or otherwise in the possession of,
Xxxxxxxx that is necessary for NuPathe to Exploit the Anti-Migraine Patent and the Products as
authorized herein.
(c) Xxxxxxxx Intellectual Property is, to Xxxxxxxx’x Knowledge, enforceable and valid, and
Xxxxxxxx has not received any notice that Xxxxxxxx Intellectual Property has been or is the subject
of (A) any pending Action (including, with respect to the Patents included in the Xxxxxxxx
Intellectual Property, inventorship challenges, interferences, reissues, reexaminations and
oppositions or similar Actions) or any Order or other agreement restricting (x) the use of any
Xxxxxxxx Intellectual Property in connection with the Exploitation of any Product in the Field or
(y) the assignment or license thereof by Xxxxxxxx (or any of its Affiliates, as applicable), or (B)
any threatened Action or claim of infringement threatened or made in writing or any pending Action
to which Xxxxxxxx (or any of its Affiliates, as applicable) is a party.
(d) Neither Xxxxxxxx nor its Affiliates, if applicable, has entered into any contract (A)
granting any Person the right to bring infringement actions with respect to, or otherwise to
enforce rights with respect to, any of Xxxxxxxx Intellectual Property in the Field in the
Territory, (B) expressly agreeing to indemnify any Person against any charge of infringement of any
of Xxxxxxxx Intellectual Property in the Field in the Territory, or (C) granting any Person the
right to control the prosecution of any of Xxxxxxxx Intellectual Property.
(e) Xxxxxxxx has not received notice that there is any unauthorized use, infringement,
misappropriation or violation of any of Xxxxxxxx Intellectual Property by any Person within the
Territory.
(f) All issuance, renewal, maintenance and other material payments that are or have become due
with respect to Xxxxxxxx Intellectual Property have been timely paid by or on behalf of Xxxxxxxx.
All documents, certificates and other material in connection with such Xxxxxxxx Intellectual
Property have, for the purposes of maintaining such Xxxxxxxx Intellectual Property, been filed in a
timely manner with the relevant Governmental Authorities.
Section 5.6 Litigation. There is no Action pending, or to Xxxxxxxx’x Knowledge, threatened
before any Governmental Authority, and there is no claim, investigation or administrative action of
any Governmental Authority pending, or to Xxxxxxxx’x Knowledge,
threatened, that affects Xxxxxxxx or the Purchased Assets or that could reasonably be expected
to result in restraining, enjoining or otherwise preventing the completion by Xxxxxxxx of the
transaction contemplated by this Agreement, nor, to Xxxxxxxx’x Knowledge, is there any reasonable
basis on which any Action may be brought in the future. There is no outstanding Order of any
Governmental Authority against Xxxxxxxx relating to the Purchased Assets.
Section 5.7 Adverse Information. Xxxxxxxx has not received any notice of any scientific or
technical facts or circumstances that would adversely affect the scientific, therapeutic or
commercial potential of the Anti-Migraine Patent.
Section 5.8 Taxes.
(a) Xxxxxxxx (and each of its Affiliates, as applicable) has timely paid all Taxes that will
have been required to be paid by it, the non-payment of which would result in a Lien on the
Purchased Assets or would result in NuPathe becoming liable or responsible therefor.
(b) Xxxxxxxx (and each of its Affiliates, as applicable) has established, in accordance with
generally accepted accounting principles, as applied in the United States, applied on a basis
consistent with that of preceding periods, adequate reserves for the payment of, and will timely
pay, all Taxes that arise from or with respect to the Purchased Assets, the non-payment of which
would result in a Lien on the Purchased Assets or would result in NuPathe becoming liable therefor.
Section 5.9 Regulatory Matters.
(a) Neither Xxxxxxxx nor any of the employees of Xxxxxxxx that conducted any activities or
services relating to the Purchased Assets and/or Products has been disqualified, debarred or
voluntarily excluded by the FDA or any other Governmental Authority for any purpose, or has been
charged with or convicted under United States federal law for conduct relating to the development
or approval, or otherwise relating to the regulation, of any drug product under the Generic Drug
Enforcement Act of 1992, the Act or any other Applicable Law, or, to Xxxxxxxx’x Knowledge, has made
an untrue statement of a material fact to any Governmental Authority with respect to the Purchased
Assets (whether in any submission to such Governmental Authority or otherwise), or failed to
disclose a material fact required to be disclosed to any Governmental Authority with respect to the
Purchased Assets. Neither Xxxxxxxx nor any employee of Xxxxxxxx has received any notice to such
effect.
(b) Xxxxxxxx has made available, or has caused its Affiliates to make available, to NuPathe
all Regulatory Documentation, Xxxxxxxx Know-How and any other data and information and inventions
in Xxxxxxxx’x or Xxxxxxxx’x Affiliates’ possession or Control as of the Effective Date regarding or
related to the Anti-Migraine Patent. To Xxxxxxxx’x Knowledge, Xxxxxxxx has prepared, maintained
and retained all Regulatory Documentation that is required to be maintained or reported pursuant to
and in accordance with good laboratory and clinical practices and other Applicable Laws.
(c) Xxxxxxxx and its Affiliates have assigned to NuPathe all of Xxxxxxxx and its Affiliates’
right, title and interest in and to all Regulatory Documentation, including, to the extent
permitted by Applicable Law, all applicable Regulatory Approvals Controlled by Xxxxxxxx
or its Affiliates at any time prior to the Effective Date. Xxxxxxxx has executed and
delivered, or caused to be executed and delivered, all such instruments and has done and caused to
be done all such acts and things, including the filing of such assignments, agreements, documents
and instruments, as were necessary under, or as NuPathe has reasonably requested in connection
with, or to carry out more effectively the purpose of, or to better assure and confirm unto NuPathe
its rights with respect to the Purchased Assets with respect to the Regulatory Documentation.
Section 5.10 Adequate Consideration. The consideration to be received by Xxxxxxxx under the
Patent Assignment constitutes fair consideration and reasonable value for the Purchased Assets and
the WEDD® Technology license.
Section 5.11 Indemnity By Xxxxxxxx. Xxxxxxxx will indemnify and hold NuPathe, its directors,
officers, employees and agents harmless against any and all liability, damage, loss, cost or
expense (including reasonable attorney’s fees) resulting from any third party claims made or suits
brought against NuPathe which arise from an act or failure to act by Xxxxxxxx or Xxxxxxxx’x breach
of any of its representations, warranties or agreements contained herein.
ARTICLE VI
REPRESENTATIONS, WARRANTIES AND INDEMNITY OF NUPATHE
REPRESENTATIONS, WARRANTIES AND INDEMNITY OF NUPATHE
NuPathe represents and warrants to Xxxxxxxx, as of the Effective Date, as follows, with each
such representation and warranty subject only to such exceptions, if any, as are set forth in the
particular disclosure schedule numbered and captioned to correspond to, and referenced in, such
representation or warranty:
Section 6.1 Organization, Standing and Power. NuPathe is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware and has all requisite
power and authority to carry on its business as now being conducted.
Section 6.2 Authority; Binding Agreements. The execution and delivery by NuPathe of this
Agreement and the Related Documents to which it is or will become a party and the consummation of
the transaction contemplated hereby have been duly and validly authorized by all necessary action
on the part of NuPathe. NuPathe has all requisite power and authority to enter into this Agreement
and the Related Documents to which it is or will become a party and to consummate the transaction
contemplated hereby, and this Agreement and such Related Documents have been, or upon execution and
delivery thereof will be, duly executed and delivered by NuPathe. This Agreement and the Related
Documents to which NuPathe is or will become a party are, or upon execution and delivery thereof
will be, the valid and binding obligations of NuPathe, enforceable against NuPathe in accordance
with their respective terms.
Section 6.3 Conflicts; Consents. The execution and delivery by NuPathe of this Agreement and
the Related Documents to which it is or will become a party, the consummation of the transaction
contemplated hereby and compliance by NuPathe with the provisions hereof and thereof do not and
will not (a) conflict with or result in a breach of the constitutive or organizational documents of
NuPathe, or (b) violate any Applicable Law with respect to NuPathe or NuPathe’s properties or
assets.
Section 6.4 Indemnity By NuPathe. NuPathe will indemnify and hold Xxxxxxxx, its directors,
officers, employees and agents harmless against any and all liability, damage, loss, cost or
expense (including reasonable attorney’s fees) resulting from any third party claims made or suits
brought against Xxxxxxxx arising from an act or failure to act by NuPathe, or NuPathe’s breach of
any of its representations, warranties or agreements contained herein.
ARTICLE VII
ADDITIONAL MATTERS
ADDITIONAL MATTERS
Section 7.1 Certain Tax Matters.
(a) Waiver of Bulk Sales. NuPathe hereby waives compliance by Xxxxxxxx with the requirements
and provisions of any “bulk-transfer” laws of any jurisdiction (including applicable Tax laws) that
may otherwise be applicable with respect to the sale of any or all of the Purchased Assets to
NuPathe (including the requirement to withhold any amount from payment of the Purchase Price);
provided, however, that Xxxxxxxx shall pay and discharge when due all claims of creditors asserted
against NuPathe or the Purchased Assets by reason of such noncompliance and shall take promptly all
necessary actions required to remove any encumbrance which may be placed upon any of the Purchased
Assets by reason of such noncompliance and otherwise indemnify NuPathe against any losses it
suffers as a result of such non-compliance.
(b) Cooperation and Exchange of Information. Each of Xxxxxxxx and NuPathe shall (i) provide
the other with such assistance as may reasonably be requested by the other party in connection with
the preparation of any Tax Return, audit or other examination by any taxing authority or Action
relating to liability for Taxes in connection with the Purchased Assets, (ii) retain and provide
the other with any records or other information that may be relevant to such Tax Return, audit or
examination, Action or determination, and (iii) provide the other with any final determination of
any such audit or examination, Action or determination that affects any amount required to be shown
on any Tax Return of the other for any period.
(c) Survival of Covenants. The covenants contained in this Section 7.1 shall survive until
thirty (30) days after the expiration of the applicable statute of limitations (including
extensions thereof).
(d) Indemnification. In addition to the indemnification provided for in Section 7.1(a),
Xxxxxxxx shall indemnify and hold NuPathe harmless for: (i) any Taxes of Xxxxxxxx and any Taxes
associated with the Purchased Assets as of the date hereof; and (ii) the breach of any of
Xxxxxxxx’x representations set forth in Section 5.8. Any transfer taxes associated with the
transfer of the Purchased Assets (including any periodic taxes associated with the Purchased Assets
for 2008) shall be apportioned between Xxxxxxxx and NuPathe on a daily proration basis.
Section 7.2 Cooperation in Anti-Migraine Patent Maintenance. From and after the Effective
Date, Xxxxxxxx shall cooperate and assist NuPathe, at NuPathe’s cost and expense, with the filing,
prosecution, defense and enforcement of the Anti-Migraine Patent, including by providing access to
inventors and other persons familiar with the conception and reduction to practice of any
information and inventions related to the Anti-Migraine Patent.
Section 7.3 Expenses. Except as expressly set forth herein, each of Xxxxxxxx and NuPathe
shall bear its own costs and expenses incurred in connection with this Agreement.
Section 7.4 Further Assurances. Xxxxxxxx shall, and shall cause its Affiliates to, at any
time and from time to time after the Effective Date, upon the request and at the cost and expense
of NuPathe, do, execute, acknowledge, deliver and file, or cause to be done, executed,
acknowledged, delivered and filed, all such further acts, deeds, transfers, conveyances,
assignments or assurances as may be reasonably required for the better transferring, conveying,
assigning and assuring to NuPathe, or for the aiding and assisting in the reducing to possession by
NuPathe of, any of the Purchased Assets, or for otherwise carrying out the purposes of this
Agreement and the Related Documents and the consummation of the transaction contemplated hereby.
ARTICLE VIII
EFFECTIVE DATE DELIVERABLES
EFFECTIVE DATE DELIVERABLES
Section 8.1 Deliveries of Xxxxxxxx. On the Effective Date, Xxxxxxxx shall deliver, or caused
to be delivered to NuPathe:
(a) a Patent Assignment, substantially in the form of Exhibit 2, as may be necessary,
among other things, to effect the assignment to NuPathe of all rights of Xxxxxxxx (and its
Affiliates, as applicable) in and to the Anti-Migraine Patent, duly executed by Xxxxxxxx (or its
Affiliates, as applicable);
(b) a properly completed IRS form W-9 duly executed by Xxxxxxxx; and
(c) such other documents, certifications and further assurances as NuPathe may reasonably
request in order to vest more effectively in NuPathe, or to put NuPathe more fully in possession
of, the Purchased Assets and any rights granted by Xxxxxxxx to NuPathe under Xxxxxxxx Patents and
Xxxxxxxx Know How.
Section 8.2 Deliveries of NuPathe. Except as otherwise provided for in this Agreement, on the
Effective Date, NuPathe shall deliver, or caused to be delivered to Xxxxxxxx:
(a) the Purchase Price pursuant to Section 3.1;
(b) the Patent Assignment duly executed by NuPathe; and
(c) such other documents, certifications and further assurances as Xxxxxxxx may reasonably
request in order to vest more effectively in Xxxxxxxx, or to put Xxxxxxxx more fully in possession
of, any rights granted by NuPathe to Xxxxxxxx under the NuPathe Intellectual Property.
ARTICLE IX
MISCELLANEOUS
MISCELLANEOUS
Section 9.1 Notices. All notices, consents, waivers and other communications under this
Agreement must be in writing and shall be deemed to have been duly given when: (a)
delivered by hand (with written confirmation of receipt), or (b) when received by the
addressee, if sent by a delivery service (prepaid, receipt requested), or (c) when received by the
addressee, if sent by registered or certified mail (postage prepaid, return receipt requested), in
each case to the appropriate addresses set forth below (or to such other addresses, representative
and telecopier numbers as a party may designate by notice to the other parties):
If to Xxxxxxxx, to:
Xxxxxxxx Pharma, Inc.
0000 Xxxxx Xxxx Xxxx (Xxxxx 000)
Xxxxxxx Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: 000-000-0000
0000 Xxxxx Xxxx Xxxx (Xxxxx 000)
Xxxxxxx Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: 000-000-0000
If to NuPathe, to:
NuPathe, Inc.
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxxxx, XX 00000
Attn: General Counsel
Facsimile: 000-000-0000
NuPathe, Inc.
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxxxx, XX 00000
Attn: General Counsel
Facsimile: 000-000-0000
Section 9.2 Waiver. Except as explicitly provided in this Agreement, the rights and remedies
of the parties under this Agreement are cumulative and not alternative and are not exclusive of any
right or remedies that any party may otherwise have at law or in equity. Except as explicitly
provided in this Agreement, neither the failure nor any delay by any party in exercising any right,
power, or privilege under this Agreement or the documents referred to in this Agreement shall
operate as a waiver of such right, power or privilege, and no single or partial exercise of any
such right, power, or privilege shall preclude any other or further exercise of such right, power,
or privilege or the exercise of any other right, power, or privilege. To the maximum extent
permitted by Applicable Law, (a) no waiver that may be given by a party shall be applicable except
in the specific instance for which it is given, and (b) no notice to or demand on one party shall
be deemed to be a waiver of any right of the party giving such notice or demand to take further
action without notice or demand.
Section 9.3 Entire Agreement; Amendment. This Agreement and the Related Documents, together
with the Settlement Agreement, supersede all prior agreements between the parties with respect to
its subject matter and constitute a complete and exclusive statement of the terms of the agreements
between the parties with respect to their subject matter. This Agreement may not be amended except
by a written agreement executed by all of the parties hereto.
Section 9.4 Assignment. Neither this Agreement nor any interest herein may be assigned, in
whole or in part, by either party hereto without the prior written consent of the other party
hereto, provided, that either party shall have the right to assign all or any part of its rights,
interest and obligations to an Affiliate, a successor to a controlling or majority share of such
party, or to a successor to substantially all the business to which this Agreement relates.
Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective permitted successors and assigns.
Section 9.5 Severability. If any term or other provision of this Agreement is invalid,
illegal or incapable of being enforced by any requirement of applicable law or public policy, all
other conditions and provisions of this Agreement shall nevertheless remain in full force and
effect so long as the economic or legal substance of the transactions contemplated hereby is not
affected in any manner adverse to any party in any material respect. Upon such determination that
any term or other provision is invalid, illegal or incapable of being enforced, the parties hereto
shall negotiate in good faith to modify this Agreement so as to effect the original intent of the
parties as closely as possible in a mutually acceptable manner in order that the transactions
contemplated hereby be consummated as originally contemplated to the greatest extent possible.
Section 9.6 Section Headings; Construction. The headings of Sections in this Agreement are
provided for convenience only and shall not affect its construction or interpretation. All
references to “Article,” “Section” or “Sections” refer to the corresponding Article, Section or
Sections of this Agreement. All words used in this Agreement shall be construed to be of such
gender or number as the circumstances require. Unless otherwise expressly provided, the word
“including” does not limit the preceding words or terms.
Section 9.7 Governing Law; Consent to Jurisdiction and Venue.
(a) This Agreement shall be governed by, and construed in accordance with, the laws of the
State of Delaware applicable to contracts executed in and to be performed in that State, without
giving effect to the conflicts of laws principles thereof to the extent such principles would
require or permit the application of the laws of another state.
(b) All actions and proceedings arising out of or relating to this Agreement shall be heard
and determined in a Delaware state or a federal court and the parties to this Agreement hereby
irrevocably submit to the exclusive jurisdiction of such courts in any such action or proceeding
and irrevocably waive the defense of an inconvenient forum to the maintenance of any such action or
proceeding. The parties hereto hereby consent to service of process by mail (in accordance with
Section 9.1 or any other manner permitted by law).
Section 9.8 Counterparts. This Agreement may be executed in one or more counterparts, each of
which shall be deemed to be an original of this Agreement and all of which, when taken together,
shall be deemed to constitute one and the same agreement. Delivery of an executed counterpart of a
signature page to this Agreement by electronic or facsimile transmission shall be effective as
delivery of a manually executed counterpart of this Agreement.
Section 9.9 Time of Essence. Time is of the essence in this Agreement.
Section 9.10 No Third Party Beneficiaries. This Agreement is for the sole benefit of the
parties hereto and nothing herein, express or implied, is intended to or shall confer upon any
other Person any legal or equitable benefit, claim, cause of action, remedy or right of any kind.
Section 9.11 Confidentiality.
(a) Any and all information provided by one party to the other pursuant to this Agreement
shall be deemed to be confidential information (“Confidential Information”). Each party will hold
Confidential Information in complete confidence and will not, with the prior
written consent of the other, use or disclose it in whole or in part to any person other than
for the purposes set forth in this Agreement for a period ending five (5) years following
expiration of this Agreement. Each party will be entitled to disclose any such Confidential
Information to such of its provisional advisors, directors, officers and senior employees who are
directly concerned with this Agreement and its implementation and whose knowledge of such
information is necessary for these purposes. Each party will use its reasonable efforts to ensure
that each individual to whom such a disclosure is made adheres to the terms of this undertaking as
if he or she were a party hereto, including without limitation, having such individuals execute
similar agreements.
(b) As used herein, the term Confidential Information shall not include information:
(i) that the recipient can demonstrate through its contemporaneous written records has become
generally available to third parties after disclosure to the recipient from a source other than the
discloser; provided that such source is not bound by a confidentiality or other similar agreement
with the discloser or by any other legal, contractual or fiduciary obligation which prohibits the
disclosure of such Confidential Information;
(ii) was lawfully in possession of the recipient prior to disclosure, as evidenced by written
records and which was not acquired directly or indirectly from the disclosing party; or
(iii) which the recipient is required by legal process, law or regulation to disclose or,
after consultation with legal counsel, determines it prudent to be disclosed to the extent required
under the laws, guidelines, or regulations or pursuant to any request by an governmental agency
lawfully requesting the same, or to any court of competent jurisdiction acting pursuant to it
lawful powers.
(c) In the event that a party intends to disclose any Confidential Information pursuant to
Section 9.11 (b)(iii) hereof, such party first shall provide the disclosing with prompt written
notice as far in advance of the proposed disclosure as possible so that the disclosing party (at
its expense) may either seek a protective order or other appropriate remedy which is necessary to
protect its interests or waive compliance with the non-disclosure provisions of this Agreement to
the extent necessary (provided that one or the other be done). The receiving party shall cooperate
in all reasonable respects with the disclosing party in seeking to prevent or limit disclosure and,
in the event a protective order or other remedy is not obtained, will limit the disclosure to the
information actually required to be disclosed.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day and year first
above written.
| NUPATHE INC. |
||||
| By: | /s/ Xxxx X. Xxxxxxxxxxxxx | |||
| Name: | X. Xxxxxxxxxxxxx | |||
| Title: | CEO | |||
| XXXXXXXX PHARMA INC. |
||||
| By: | /s/ Xxxxxx Xxxxx | |||
| Name: | Xxxxxx Xxxxx | |||
| Title: | [ILLEGIBLE] | |||
EXHIBIT 1
Xxxxxxxx Patents
Any of the following Patents necessary or required to develop, make, have made, use, sell,
offer to sell or import Products in the Field:
| File No. | Title | Filing Date | Status | |||
| I. ISSUED U.S. PATENTS (6) |
||||||
990322.CIP
|
CONTROLLED DOSAGE DRUG | CIP-June 10, 2002 | UPSN 7,031,768; issued | |||
| DELIVERY SYSTEM | April 18, 2006 | |||||
| PRO-December 30, 1999 | ||||||
20000315.ORI
|
RATE ADJUSTABLE DRUG | ORI-July 11, 2000 | USPN 6,421,561; issued | |||
| DELIVERY SYSTEM | July 16, 2002 | |||||
| (plural power source + component) | ||||||
20000315.CIP
|
RATE ADJUSTABLE DRUG | June 3, 2002 | UPSN 7,016,723; issued | |||
| DELIVERY SYSTEM | March 21, 2006 | |||||
| (includes dosage capacity based on tested lots) | ||||||
20010197.ORI
|
POWER SOURCES FOR | USPN 6,653,014; issued | ||||
| IONTOPHORETIC DRUG DELIVERY | May 30, 2001 | November 25, 2003 | ||||
| SYSTEMS | ||||||
20020208.ORI
|
DOSAGE CONTROL ELECTRODE | February 21, 2003 | USPN 7,031,769; issued | |||
| FOR IONTOPHORESIS DEVICE | April 18, 2006 | |||||
20030061.ORI
|
IONTOPHORETIC DRUG DELIVERY | February 21, 2003 | USPN 6,745,071; issued | |||
| SYSTEM | June 1, 2004 | |||||
| File No. | Title | Filing Date | Status | |||
| II. PATENTS ISSUED OUTSIDE U.S. (8) |
||||||
990322.EP
|
CONTROLLED DOSAGE DRUG | August 18, 1999 | Xxx No. 1,115,454; issued | |||
| DELIVERY SYSTEM | October 25, 2006 | |||||
20000315.EP
|
RATE ADJUSTABLE DRUG | October 4, 2000 | Xxx. No. 1242142; issued | |||
| DELIVERY SYSTEM | September 5, 2007 | |||||
20020208.EP.CIP
|
DOSAGE CONTROL ELECTRODE | September 16, 2005 | Xxx. No. 1596931; issued | |||
| FOR IONTOPHORESIS DEVICE | February 28, 2007 | |||||
20020208.CA.CIP
|
DOSAGE CONTROL ELECTRODE | August 31, 2005 | Xxx. No. 2,512,352; issued | |||
| FOR IONTOPHORESIS DEVICE | August 7, 2007 | |||||
20020208.KR.CIP
|
DOSAGE CONTROL ELECTRODE | August 19, 2005 | Xxx. No. 0745233; issued | |||
| FOR IONTOPHORESIS DEVICE | July 26, 2007 | |||||
20030061.AU
|
IONTOPHORETIC DRUG DELIVERY | August 11, 2005 | Xxx. No. 2003267229; issued | |||
| SYSTEM | March 20, 2008 | |||||
00000000.XX
|
IONTOPHORETIC DRUG DELIVERY | August 31, 2005 | Xxx. No. 2,512,368; issued | |||
| SYSTEM | December 19, 2006 | |||||
00000000.XX
|
IONTOPHORETIC DRUG DELIVERY | August 19, 2005 | Xxx. No. 0735939; issued | |||
| SYSTEM | June 28, 2007 | |||||
| File No. | Title | Filing Date | Status | |||
| III. PENDING U.S. PATENTS |
||||||
20020208.CIP
|
DOSAGE CONTROL ELECTRODE | August 15, 2005 | ||||
| FOR IONTOPHORESIS DEVICE | ||||||
20030304.ORI
|
ABUSE POTENTIAL REDUCTION | January 23, 2004 | ||||
| SYSTEM FOR ABUSABLE SUBSTANCE | ||||||
| DOSAGE FORM | ||||||
20050269.ORI
|
TRANSDERMAL SYSTEMS FOR | April 22, 2005 | ||||
| THE DELIVERY OF THERAPEUTIC | ||||||
| AGENTS INCLUDING GRANISETRON | ||||||
| USING IONTOPHORESIS | ||||||
20051390.ORI
|
TRANSDERMAL SYSTEMS FOR THE | December 21, 2007 | ||||
| DELIVERY OF ANESTHETIC AGENTS | ||||||
| FOR THE SUSTAINED PAIN MANAGEMENT | ||||||
| OF WOUNDS AND SURGICAL REPAIRED INCISIONS | ||||||
00000000.XXX
|
TRANSDERMAL METHODS AND | August 28, 2007 | ||||
| SYSTEMS FOR THE DELIVERY OF | ||||||
| CORTICOSTEROID COMPOUNDS | ||||||
| IV. PATENTS PENDING OUTSIDE X.X. |
||||||
000000.XX
|
CONTROLLED DOSAGE DRUG | August 18, 1999 | ||||
| DELIVERY SYSTEM | ||||||
990322.JP.DIV
|
CONTROLLED DOSAGE DRUG | August 18, 2006 | ||||
| DELIVERY SYSTEM | ||||||
00000000.XX
|
RATE ADJUSTABLE DRUG | July 1, 2002 | ||||
| DELIVERY SYSTEM | ||||||
20000315.JP.DIV
|
RATE ADJUSTABLE DRUG | August 25, 2006 | ||||
| DELIVERY SYSTEM | ||||||
20020208.AU.CIP
|
DOSAGE CONTROL ELECTRODE | August 11, 2005 | ||||
| FOR IONTOPHORESIS DEVICE | ||||||
20020208.CN.CIP
|
DOSAGE CONTROL ELECTRODE | October 21, 2005 | ||||
| FOR IONTOPHORESIS DEVICE | ||||||
| File No. | Title | Filing Date | Status | |||
20020208.JP.CIP
|
DOSAGE CONTROL ELECTRODE | August 19, 2005 | ||||
| FOR IONTOPHORESIS DEVICE | ||||||
00000000.XX
|
IONTOPHORETIC DRUG DELIVERY | October 21, 2005 | ||||
| SYSTEM | ||||||
20030061.EP
|
IONTOPHORETIC DRUG DELIVERY SYSTEM |
September 13, 2005 | ||||
00000000.XX
|
IONTOPHORETIC DRUG DELIVERY | August 19, 2005 | ||||
| SYSTEM | ||||||
20030304.EP
|
ABUSE POTENTIAL REDUCTION | January 20, 2005 | ||||
| IN ABUSABLE SUBSTANCE DOSAGE | ||||||
| FORM | ||||||
00000000.XX
|
ABUSE POTENTIAL REDUCTION | January 20, 2005 | ||||
| IN ABUSABLE SUBSTANCE DOSAGE | ||||||
| FORM | ||||||
20050269.AU
|
TRANSDERMAL SYSTEMS FOR | March 24, 2006 | ||||
| THE DELIVERY OF THERAPEUTIC | ||||||
| AGENTS INCLUDING GRANISETRON | ||||||
| USING IONTOPHORESIS | ||||||
00000000.XX
|
TRANSDERMAL SYSTEMS FOR | March 24, 2006 | ||||
| THE DELIVERY OF THERAPEUTIC | ||||||
| AGENTS INCLUDING GRANISETRON | ||||||
| USING IONTOPHORESIS | ||||||
00000000.XX
|
TRANSDERMAL SYSTEMS FOR | March 24, 2006 | ||||
| THE DELIVERY OF THERAPEUTIC | ||||||
| AGENTS INCLUDING GRANISETRON | ||||||
| USING IONTOPHORESIS | ||||||
20050269.EP
|
TRANSDERMAL SYSTEMS FOR | March 24, 2006 | ||||
| THE DELIVERY OF THERAPEUTIC | ||||||
| AGENTS INCLUDING GRANISETRON | ||||||
| USING IONTOPHORESIS |
| File No. | Title | Filing Date | Status | |||
00000000.XX
|
TRANSDERMAL SYSTEMS FOR | March 24, 2006 | ||||
| THE DELIVERY OF THERAPEUTIC | ||||||
| AGENTS INCLUDING GRANISETRON | ||||||
| USING IONTOPHORESIS | ||||||
20060655.WP
|
TRANSDERMAL METHODS AND | April 12, 2007 | ||||
| SYSTEMS FOR THE DELIVERY OF | ||||||
| ANTI-MIGRAINE COMPOUNDS |
EXHIBIT 2
Form of Patent Assignment Agreement
(See attached)
PATENT ASSIGNMENT AGREEMENT
WHEREAS, Xxxxxxxx Pharma, Inc., a Minnesota corporation whose principal place of business is
located at 2500 Xxxxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx Xxxxxxx, XX 00000 (“Assignor”), and NuPathe,
Inc., a Delaware corporation whose principal place of business is 220 Xxxxxxxxxx Xxxxxx, Xxxxx 000,
Xxxxxxxxxxxx, XX 00000 (“Assignee”), are parties to that certain Asset Purchase and License
Agreement dated as of July 8, 2008 (the “Purchase Agreement”);
WHEREAS, pursuant to said Purchase Agreement, Assignor has agreed to enter into this Patent
Assignment Agreement (the “Patent Assignment”) to assign and transfer the Anti-Migraine Patent (as
such term is defined in the Purchase Agreement) and statutory invention registration listed in the
attached Schedule A (collectively, the “Assigned Patent”) to Assignee; and
WHEREAS, Assignor is the owner of all rights, titles and interests throughout the Territory
in, under and to the inventions claimed by the Assigned Patent (“Patent Rights”), and Assignee is
desirous of acquiring all of said Assigned Patent and Patent Rights.
NOW, THEREFORE, in consideration of the payment by Assignee to Assignor of the sum of Five
Million Five Hundred Thousand Dollars ($5,500,000), and for other good and valuable consideration,
the receipt of which is hereby acknowledged, the parties hereto agree as follows:
1. Assignor does hereby assign to Assignee, all right, title and interest in and to the
Assigned Patent and Patent Rights, including any and all causes of action, rights and remedies
arising under such Assigned Patent or Patent Rights prior to or after the effective date of this
Patent Assignment, and any divisions, reissues, continuations, continuations-in-part, renewals,
extensions, revisions and foreign counterparts of such Assigned Patent and Patent Rights to be held
and enjoyed by Assignee for its own use and benefit and for the use and benefit of its successors,
assigns or other legal representatives to the end of the term for which such Assigned Patent and
Patent Rights are granted or reissued as fully and entirely as the same would have been held and
enjoyed by Assignor if this assignment had not been made.
2. Assignor authorizes and empowers Assignee or its nominees to invoke and claim for the
Assigned Patent and Patent Rights any and all other form of protection, the benefit of the right of
priority provided by the International Convention for the Protection of Industrial Property, as
amended, or by any convention which may henceforth be substituted for it, and to invoke and claim
such right of priority without further written or oral authorization from Assignor.
3. Assignor hereby consents that a copy of this assignment shall be deemed a full legal and
formal equivalent of any assignment, consent to file or like
document which may be required in the United States or any foreign country for any purpose, and
more particularly but without limitation in proof of the right of Assignee or its nominees to claim the aforesaid benefit of the right of priority provided by the International Convention
for the Protection of Industrial Property, as amended, or by any convention which may henceforth be
substituted for it.
4. Assignor hereby authorizes the respective officials whose duty it is to issue patent rights
or other forms of industrial property protection to issue to or as requested by Assignee, in
accordance with the terms of this Patent Assignment, the Assigned Patent and Patent Rights, and to
issue any and all letters patent and Patent Rights resulting from the Assigned Patent and Patent
Rights and from any and all reissues, re-examinations, divisions, continuations, renewals,
extensions, continuations-in-part, revisions, and foreign counterparts thereof, such that all
letters patent and other Patent Rights resulting from the Assigned Patent and Patent Rights, and
any worldly rights not expressly referenced herein on the inventions, vest in and accrue to
Assignee.
5. Assignor hereby represents and warrants that it has the full right and power to convey the
entire rights, titles and interests herein assigned and that it has not executed and will not
execute any agreement in conflict herewith.
6. At the request of Assignee, Assignor agrees to execute and deliver all documents, papers,
instruments and assignments, and to perform any other reasonable acts Assignee may require, in
order to vest in Assignee all of Assignor’s rights, titles, and interests in and to the Assigned
Patent and the Patent Rights, including but not limited to execution and delivery of such documents
with respect to particular Assigned Patent in particular countries in the Territory, delivery of
all Documents (as the term is used in the Purchase Agreement), and the transfer of power of
attorney and other indicia of authority pertaining to the Assigned Patent, delivery of
instructions to Foreign Associates to look to Assignee for all further instructions relating to the
Assigned Patent, and the provision of evidence to support any of the foregoing in the event such
evidence is deemed necessary by Assignee, to the extent such evidence is in the possession or
control of Assignor.
7. Assignor hereby irrevocably makes, constitutes and appoints Assignee, and authorizes and
empowers Assignee to make, constitute and appoint any officer or agent of Assignee as Assignee may
select in its exclusive discretion, as such Assignor’s true and lawful attorney-in-fact, with full
power of substitution and with the absolute power and authority to take any and all action and to
execute thereafter any and all applications, documents, papers, filings and instruments which
Assignee deems necessary or desirable to accomplish the purposes of this Assignment. Assignor
hereby ratifies and confirms all that such attorney shall lawfully do or cause to be done by virtue
hereof.
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IN WITNESS WHEREOF, Assignor has executed this Patent Assignment as of the date first set
forth above.
| ASSIGNOR: | ||||
| XXXXXXXX PHARMA, INC. | ||||
| By: | ||||
| Name: | ||||
| Title: | ||||
| Place of Execution: | ||||
STATE OF §
COUNTY OF §
COUNTY OF §
I, the undersigned Notary Public, do hereby attest that before me on this day personally
appeared , known to me to be the person whose name is subscribed to the foregoing
instrument, who acknowledged to me that he executed the same for the purposes and consideration
therein expressed, in the capacity therein stated and as the act and deed of said corporation.
GIVEN UNDER MY HAND and seal of office this day of , 2008.
| Notary Public in and for the State of | ||||
| My Commission Expires: | ||||
(Seal)
ACKNOWLEDGED AND ACCEPTED this Patent Assignment from Assignor as of the date first set forth
above.
| ASSIGNEE: | ||||
| NUPATHE, INC. | ||||
| By: | ||||
| Name: | ||||
| Title: | ||||
| Place of Execution: | ||||
STATE OF §
COUNTY OF §
COUNTY OF §
I, the undersigned Notary Public, do hereby attest that before me on this day personally
appeared , known to me to be the person whose name is subscribed to the foregoing
instrument, who acknowledged to me that he executed the same for the purposes and consideration
therein expressed, in the capacity therein stated and as the act and deed of said corporation.
GIVEN UNDER MY HAND and seal of office this day of , 2008.
| Notary Public in and for the State of | ||||
| My Commission Expires: | ||||
(Seal)
Schedule A
Patent
| Title | Application No. | Patent No. | Filing Date | Grant Date | ||||
Transdermal Methods
|
PCT/US07/09000 | April 12, 2007 | ||||||
and Systems for the
|
WO/2007/120747 | |||||||
Delivery of |
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Anti-Migraine |
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Compounds Related |
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Applications |
