Exhibit 10.41

Portions of this exhibit marked [*] are requested to be treated confidentially.

Execution Copy

SECOND AMENDMENT AND AGREEMENT

THIS SECOND AMENDMENT AND AGREEMENT (“Second Amendment”) is made as of December
21, 2012 (“Second Amendment Effective Date”) by and between Coronado Biosciences
Inc., a corporation organized and existing under the laws of the State of
Delaware and having its principal office at 24 New England Executive Park,
Burlington, MA 01803, United States (“Coronado”) and Ovamed GmbH, a company with
limited liability organized and existing under the laws of Germany and having
its principal office at Kiebitzhörn 31, 22885 Barsbüttel, Germany (“Ovamed”).
Coronado and Ovamed are sometimes referred to herein individually as a “Party”
and collectively as the “Parties”.

W I T N E S S E T H:

WHEREAS, Coronado and Ovamed are parties to (a) an Exclusive Sublicense
Agreement dated December 12, 2005 (as amended, the “Sublicense Agreement”),
(b) a Manufacturing and Supply Agreement dated March 29, 2006 (as amended, the
“Supply Agreement”), (c) the Letter Agreement dated November 8, 2007 (the
“Letter Agreement”), (d) the Term Sheet dated June 8, 2010 (the “Term Sheet”),
(e) the Amendment and Agreement dated January 7, 2011, and (f) together with the
University of Iowa Research Foundation (“UIRF”), the Side Agreement effective as
of November 15, 2011 (the “Side Agreement”) (all of the foregoing agreements, as
amended and in effect immediately prior to the Second Amendment Effective Date,
being collectively referred to herein as the “Agreements”);

WHEREAS, Ovamed and ParaTech (as defined below) have entered into the Restated
Exclusive Production and Supply Agreement effective March 20, 2012 (the
“ParaTech Agreement”), providing for the exclusive supply of non-embryonated TSO
by ParaTech to Ovamed and the exclusive purchase of non-embryonated TSO by
Ovamed from ParaTech, which exclusivity also obligates Ovamed not to permit its
sub-licensees under the Patent Rights to purchase from third parties or
manufacture themselves non-embryonated TSO, a copy of which (partially redacted,
however showing the material supply terms of said ParaTech Agreement) has been
provided to Coronado; and

WHEREAS, the Parties desire to, among other things, provide for the grant from
Ovamed to Coronado of the Manufacturing License (as defined below) and for
certain agreements between the Parties and amendments to the Agreements relating
to the foregoing.

NOW, THEREFORE, in consideration of the foregoing and the mutual agreements and
covenants herein contained, the Parties, intending to be legally bound, hereby
agree, effective, except as otherwise specifically set forth herein, as of the
Second Amendment Effective Date, as follows:

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1. Definitions. Except as otherwise set forth herein, capitalized terms not
otherwise defined or amended in this Second Amendment shall have the meaning
ascribed to them in the Agreements. Any capitalized term defined in this Second
Amendment (including in any provision of an Agreement amended by this Second
Amendment) shall either amend, restate and/or supersede any definition of such
term previously defined in any of the Agreements or, if not previously defined,
shall be deemed added to the Agreements as defined in this Second Amendment.
Accordingly, the following terms, where used in this Second Amendment and, from
and after the Second Amendment Effective Date, the Agreements, in the singular
or plural, shall have the respective meanings set forth below:

1.1 “Affiliate” shall mean any corporation, firm, limited liability company,
partner-ship or other entity, which directly or indirectly controls or is
controlled by or is under common control with a Party to this Agreement. For the
purposes of this Paragraph 1.1, “control” means ownership, directly or through
one or more Affiliates, of fifty percent (50%) or more of the shares of stock
entitled to vote for the election of directors, in the case of a corporation, or
fifty percent (50%) or more of the equity interests in the entity, in the case
of any other type of legal entity, status as a general partner in any
partnership, or any other arrangement whereby a party controls or has the right
to control the direction of the management or policies of an entity, whether
through the ownership of voting securities, by contract or otherwise. For the
avoidance of doubt, the Parties agree that a company is deemed to be under
“common control with” another company if the two companies are owned or
controlled by the same group of individuals.

1.2 “CGMP” means (a) Current Good Manufacturing Practices and General Biologics
Standards, as promulgated under the European Directive 2003/94/EC and ICH Q7A
and ICH Q10 (Guideline on Good Manufacturing Practice for Active Pharmaceutical
Ingredients and Pharmaceutical Quality System, respectively) and (b) Current
Good Manufacturing Practice as established in the U.S. Federal Food, Drug and
Cosmetic and Public Health Service Act and promulgated thereunder in the
Regulations of the U.S. Code of Federal Regulations Title 21 (21 C.F.R. ss. 210,
211 and 600), or any successors thereto and as any of the foregoing may be
amended from time to time, and any other rules or regulations which may be
applicable to Manufacturing Activities for the United States and Europe.

1.3 “Collaboration Agreement” means the Collaboration Agreement by and among
Coronado, OvaMed, and Dr. Falk Pharma GmbH (“Falk”) dated as of March 20, 2012.

1.4 “Competing Product” means a biological product marketed by a third party
(other than an Affiliate of Coronado or an entity enabled, aided or abetted by
Coronado) that:

(a) for purposes of Article 9.6 of the Sublicense Agreement, (i) has been
approved as “biosimilar” to Product or “interchangeable” with Product under the
United States Biologics Price Competition and Innovation Act of 2009 and the
rules, regulations and guidances thereunder or any successors thereto and as any
of the foregoing may be amended from time to time (the “BPCI Act”), and (ii) has
achieved a market share in the United States of [*] percent ([*]%) or [*]; and

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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(b) for purposes of Article 4.7.4 of the Sublicense Agreement, (i) has been
approved under the BPCI Act as “biosimilar” to or “interchangeable” with Product
or any other product approved by the FDA for the same indication as Product, and
(ii) has achieved a market share in the United States of [*] percent ([*]%) or
greater of the total unit volume of Product in the United States.

1.5 “Coronado Per Unit Manufacturing Costs” means, for any calendar year,
(a) the aggregate costs (including costs payable to third parties) incurred by
Coronado in connection with Coronado’s Manufacturing Activities and expenses
included under the caption “Included Cost Categories” on Appendix 1.5(a) that
are associated with Products included in Net Sales for such calendar year,
divided by (b) the number of Products included in such Net Sales; for the
avoidance of doubt, Coronado Per Unit Manufacturing Costs shall not include an
allocation for those Manufacturing Activities and expenses (x) under the caption
“Excluded Cost Categories” on Appendix 1.5(b), or (y) for Product that is used
in research and development activities or sold at or below the fully burdened
cost of manufacturing solely for non-profit research or clinical testing or for
indigent or similar public support or compassionate use programs.

1.6 “Ex-Territory” means all countries and jurisdictions outside the Territory.

1.7 “Gross Margin” means, for any calendar quarter, the amount, expressed as a
percentage, obtained by (a) subtracting from Net Sales for such calendar quarter
the sum of, to the extent applicable for such calendar quarter, (i) Coronado Per
Unit Manufacturing Costs multiplied by the number of Products included in such
Net Sales, (ii) Manufacturing Fees, (iii) royalties paid and payable to OvaMed
under the Sublicense Agreement, and (iv) royalties paid and payable to Falk
under the Collaboration Agreement, in each case for such calendar quarter; and
(b) dividing the result by such Net Sales.

1.8 “Inability to Supply” means, (a) with respect to the Territory, that
Coronado and/or its designees are unable to manufacture and supply Product in
compliance with CGMPs and the Specifications and/or in the quantities and within
the time periods necessary to meet clinical or commercial requirements, and
(b) with respect to the Ex-Territory, that Ovamed and/or its designees are
unable to manufacture and supply Product in compliance with CGMPs and the
Specifications and/or in the quantities and within the time periods necessary to
meet clinical or commercial requirements (in each case including the
requirements of the applicable Party’s licensees or sub-licensees).

1.9 “Invention” shall mean any discoveries, processes, methods, technologies or
improvements and Know-How related to the formulation, delivery, presentation or
manufacture of Product or Manufacturing Activities.

1.10 “Lease” means the Commercial Lease (including the Rider to Lease) dated as
of December 21, 2012 by and between TSO Laboratories, as lessee, and Cummings
Property, LLC, as lessor, for certain premises located at 233 and 230 West
Cummings Park, Woburn MA, relating to the US Facility, a complete and accurate
copy of which has been provided to Coronado.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

3

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1.11 “License Agreement” means the exclusive License Agreement dated December 8,
2005 by and between UIRF and Ovamed, as amended by the Side Agreement.

1.12 “Manufacturing Activities” means the activities and operations to be
undertaken by each Party depending on the context (or its respective designees,
including third party manufacturers and subcontractors), in the manufacture
(including embryonation), quality control testing (including in-process, release
and stability testing when applicable), and release of Product to meet the
Specifications, and supply of clinical and commercial quantities of Product in
accordance with Regulatory Standards.

1.13 “Manufacturing Assumption Date” means the effective date of Coronado’s
assumption of Manufacturing Activities, which date shall (a) be provided by
Coronado to Ovamed in writing, and (b) be no earlier than the satisfaction of
both of the following and no later than sixty (60) days after satisfaction of
both of the following: the (i) acceptance by the FDA of the amendment(s) to
Coronado’s IND containing chemistry, manufacturing and controls (“CMC”)
information, including information associated with Manufacturing Activities at
the US Facility (the “CMC Amendment”) and (ii) execution of the Non-Embryonated
TSO Supply Agreement.

1.14 “Manufacturing Fee” shall have the meaning set forth in Article 4.7 of the
Sublicense Agreement, as amended by this Second Amendment.

1.15 “Manufacturing License” shall have the meaning set forth in Article 2.1 of
the Sublicense Agreement, as amended by this Second Amendment.

1.16 “Manufacturing Patent Rights” means any patents, patent applications,
certificates of invention, or applications for certificates of invention and any
supplemental protection certificates, together with any extensions,
registrations, confirmations, reissues, substitutions, divisions, continuations
or continuations-in-part, reexaminations or renewals thereof that claim an
Invention (other than the Falk Patent Rights, as defined in the Collaboration
Agreement).

1.17 “Non-Embryonated TSO Supply Agreement” shall have the meaning set forth in
Paragraph 2.6 of this Second Amendment.

1.18 “Ovamed Per Unit Manufacturing Costs” means, for any calendar year, (a) the
aggregate costs (including costs payable to third parties) incurred by Ovamed in
connection with Ovamed’s Manufacturing Activities and expenses under the caption
“Included Cost Categories” on Appendix 1.5(a) for such calendar year divided by
(b) the number of Products manufactured and sold by Ovamed during such calendar
year; for the avoidance of doubt, Ovamed Per Unit Manufacturing Costs shall not
include an allocation for those Manufacturing Activities and expenses (x) under
the caption “Excluded Cost Categories” on Appendix 1.5(b), or (y) for Product
that is used in research and development activities or sold at or below the
fully burdened cost of manufacturing solely for non-profit research or clinical
testing or for indigent or similar public support or compassionate use programs.

1.19 “ParaTech” means Parasite Technologies A/S, a Danish corporation registered
with the Danish Commerce and Companies Agency under company registration number
27 97 18 22 with its principal office at Vallerød Banevej 12, DK2960 Rungsted
Kyst.

 

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1.20 “Product(s)” means any pharmaceutical or medicinal product(s) containing
Trichuris suis ova (“TSO”) as an active substance, incorporated into any
formulation or delivery system.

1.21 “Regulatory Standards” means (i) obtaining and maintaining any and all
permits, licenses, filings and certifications required by the FDA or other
Regulatory Authorities, (ii) compliance with CGMPs, and (iii) compliance with
laws, rules, regulations and standards of any applicable Regulatory Authority.

1.22 “Second Amendment” means this Second Amendment and Agreement entered into
by and between the Parties and effective as of the Second Amendment Effective
Date.

1.23 “Second Source Agreement” shall have the meaning set forth in Paragraph 2.5
of this Second Amendment.

1.24 “Specifications” means the quality assurance and quality control
specifications for Product, which are the specifications set forth in the U.S.
IND for Product as of the Second Amendment Effective Date, as such
specifications may be modified from time to time as required by Regulatory
Standards and by mutual agreement of the Parties.

1.25 “Technical Information” means the Know-how, techniques, processes,
formulae, methods, equipment specifications, documents and other technical
information relating to the proper manufacture, packaging, quality control,
release, disposal, storage, handling and/or shipping of Product and embryonated
TSO, as applicable, included in the documents listed in Appendix 1.25.

1.26 “Technology Transfer” shall have the meaning set forth in Paragraph 2.2 of
this Second Amendment.

1.27 “Territory” means North America, South America and Japan.

1.28 “TSO Laboratories” means TSO Laboratories, Inc., a Massachusetts
corporation and wholly-owned subsidiary of Ovamed, with an office at 355
Providence Highway, Suite 200, Westwood, MA 02030.

1.29 “Typically Sub-Contracted Manufacturing Activities” shall have the meaning
set forth in Paragraph 2.1.6 of this Second Amendment.

1.30 “Unit” means approximately [*], and references herein to per Unit amounts
assume that a treatment dose will require [*] Units [*], and that dosing will be
every two weeks.

1.31 “US Facility” means the manufacturing facility for conducting Manufacturing
Activities (a) as required by the Agreements as in effect immediately prior to
the Second Amendment Effective Date to be established by OvaMed in the United
States, and (b) in accordance with the Manufacturing License and related
amendments to the Agreements set forth in this Second Amendment, to be
established by Coronado in the United States.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

5

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2. Grant of Manufacturing License, Cross-Licenses and Related Agreements between
the Parties.

2.1 General. In accordance with the provisions of this Paragraph 2 of this
Second Amendment and Article 2.1 of the Sublicense Agreement, as amended by this
Second Amendment, (a) Coronado shall have the right and license under the Patent
Rights, the Technical Information and the Know-how to make and have made
Product; (b) Ovamed shall provide Coronado with the Technology Transfer; and
(c) the Parties shall have the cross-licenses provided under Paragraph 2.3 of
this Second Amendment.

2.1.1 In consideration of the foregoing and as compensation for Ovamed not being
the exclusive supplier of Product to Coronado, Coronado shall pay Ovamed (a) an
aggregate of $1,500,000, payable in accordance with Article 4.8 of the
Sublicense Agreement, and (b) the Manufacturing Fee in accordance with Article
4.7 of the Sublicense Agreement (in each case as the Sublicense Agreement is
amended by this Second Amendment); for the avoidance of doubt, the foregoing
payment obligations are additional to the other payment obligations of Coronado
under the Sublicense Agreement.

2.1.2 Effective from and after the Manufacturing Assumption Date, Ovamed’s
rights and obligations under the Supply Agreement to manufacture and supply all
of Coronado’s requirements for Product for the Territory shall terminate, and
Coronado shall assume Manufacturing Activities for the Territory, provided,
however, that each Party’s rights and obligations incurred prior to the
Manufacturing Assumption Date under the Supply Agreement (including with respect
to Product subject to unfulfilled Purchase Orders as of, and Product supplied
prior to, the Manufacturing Assumption Date), shall survive such termination as
set forth in Paragraph 3.3 of this Second Amendment.

2.1.3 Ovamed’s obligations under the Letter Agreement and the Supply Agreement
to establish the US Facility shall (a) effective from and after the Second
Amendment Effective Date, be suspended, provided that Ovamed is performing in
good faith its Technology Transfer obligations in accordance with Paragraph 2.2
of this Second Amendment, and (b) effective from and after the Manufacturing
Assumption Date, terminate.

2.1.4 Subject to Paragraph 2.5 of this Second Amendment and the Second Source
Agreement, Ovamed shall have the right and shall use commercially reasonable
efforts to make and have made Product for the Territory as a qualified second
source supplier in the event of a Coronado Inability to Supply, and Coronado
shall have the right and shall use commercially reasonable efforts to make and
have made Product for the Ex-Territory as a qualified second source supplier in
the event of an Ovamed Inability to Supply.

2.1.5 Each Party shall (a) perform all Manufacturing Activities and maintain all
facilities owned or controlled by it relating to the Manufacturing Activities in
compliance and conformance with CGMPs, the Specifications, approved
manufacturing procedures and validated test methods and applicable Regulatory
Standards, and (b) unless otherwise agreed to by ParaTech, during the term of
the ParaTech Agreement and the Non-Embryonated TSO Supply Agreement, as
applicable, use exclusively non-embryonated TSO supplied by ParaTech in
connection with the manufacture of Product.

 

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2.1.6 Although it is intended by the Parties that the applicable Party (or its
Affiliates or permitted Sublicensees) shall perform the Manufacturing Activities
for their respective territory (and, pursuant to the Second Source Agreement,
for the other Party’s territory) at such Party’s respective manufacturing
facilities, the Parties acknowledge and agree that (a) certain Manufacturing
Activities (for example, analytical, formulation, finishing, labeling,
packaging, and such other activities that, in the pharmaceutical industry, are
typically subcontracted, collectively, “Typically Sub-Contracted Manufacturing
Activities”) are expected to be performed by subcontractors to the applicable
Party, and (b) if in Coronado’s reasonable judgment, Coronado determines that
Manufacturing Activities in addition to Typically Sub-Contracted Manufacturing
Activities should also be performed by a third party contractor, Coronado shall
so advise Ovamed of the basis for and the Parties shall discuss such
determination. For clarification, in the event Manufacturing Activities are so
conducted by a third party contractor other than Ovamed, (i) the determination
of any Manufacturing Fee payable by Coronado in accordance with Article 4.7 of
the Sublicense Agreement shall include Products included in Net Sales that are
manufactured by such third party contractor; and (ii) such third party
contractor shall be subject to confidentiality obligations at least as
restrictive as those between the Parties and shall provide Coronado with rights
(including sublicense rights) to Manufacturing Patent Rights claiming Inventions
discovered, developed, conceived or reduced to practice as a result of such
Manufacturing Activities conducted by such third party contractor.

2.2 Technology Transfer. Ovamed shall provide the following to enable Coronado
to submit to the FDA the CMC Amendment and to assume Manufacturing Activities at
the US Facility (the “Technology Transfer”):

2.2.1 As soon as practicable after the Second Amendment Effective Date, but no
later than thirty (30) days after the Second Amendment Effective Date, Ovamed
shall provide and transfer to Coronado via an electronic data room the Technical
Information. If, in Coronado’s reasonable judgment, the Technical Information is
not sufficient to enable Coronado to submit to the FDA or obtain FDA approval of
the CMC Amendment or to assume Manufacturing Activities at the US Facility,
Ovamed shall, upon reasonable request of Coronado, provide such further
information, documentation and materials in Ovamed’s possession as may be
reasonably necessary to submit to the FDA or obtain FDA approval of the CMC
Amendment and to enable Coronado to assume Manufacturing Activities at the US
Facility. To the extent not in the possession of Ovamed but in the possession of
subcontractors of Ovamed, Ovamed shall use commercially reasonable efforts to
procure that its subcontractors provide test methods and validation reports so
required.

2.2.2 Ovamed shall provide Coronado reasonable time to consult with Ovamed’s
technical personnel and to observe each of their performance of such activities
in actual practice, and make available to Coronado at the US Facility
knowledgeable Ovamed personnel familiar with Manufacturing Activities and CMC
issues, both during the transfer and for a period of six (6) months after the
Manufacturing Assumption Date, at mutually agreeable times. Coronado shall
reimburse Ovamed for approved travel and other out-of-pocket expenses actually
incurred by Ovamed in making such Ovamed personnel available at the US Facility
at Coronado’s request. Further, should the consulting time (whether at the US
Facility or otherwise, excluding travelling time) requested by Coronado and
provided by Ovamed exceed an aggregate total of 100 hours, Coronado shall pay to
Ovamed a reasonable fee for the respective personnel at hourly rates to be

 

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mutually agreed in good faith. For the avoidance of doubt, the foregoing fee
shall not apply with respect to Services provided under the Consulting Agreement
provided for under Paragraph 2.4 of this Second Amendment. Ovamed shall use
commercially reasonable efforts to cause ParaTech to provide Coronado and/or its
designee with such access to such personnel and activities as may be required
for Coronado to assume Manufacturing Activities at the US Facility.

2.2.3 Coronado shall use commercially reasonable efforts to (i) submit the CMC
Amendment to the FDA as soon as practicable after Ovamed’s providing the
Technical Information and shall provide a copy of such CMC Amendment to Ovamed
for use by Ovamed in performing Manufacturing Activities in accordance with the
Second Source Agreement, and (ii) assume the Manufacturing Activities at the US
Facility identified in the Lease as soon as practicable thereafter and as
legally permissable.

2.2.4 For the avoidance of doubt, all Technical Information and other
information, documentation and other materials furnished or made available by
Ovamed to Coronado in connection with the Technology Transfer shall be treated
as Confidential Information of Ovamed.

2.3 Cross-Licenses to Inventions and Manufacturing Patent Rights. Subject to the
provisions of Paragraph 2.5 of this Second Amendment and the Second Source
Agreement and to each Party’s rights and obligations under the Collaboration
Agreement (which, to the extent inconsistent or in conflict with any of the
provisions of this Paragraph 2.3 shall control), (a) Ovamed hereby grants to
Coronado the exclusive right and license (with the right to grant sublicenses)
to and under Ovamed’s right, title and interest in any (i) Inventions existing
as of the Effective Date or discovered, developed, conceived or reduced to
practice thereafter (hereinafter, “Created”) solely by Ovamed (including by any
employees or consultants of Ovamed or agents or sub-contractors of Ovamed that
have contractually agreed to assign or license with sub-licensing rights to
Ovamed their interests in Inventions and intellectual property rights claiming
Inventions), and (ii) Manufacturing Patent Rights (including rights thereto
licensed to Ovamed), to make, have made, use, have used, lease, import, offer to
sale, sell and/or have sold (including to practice and have practiced the
Licensed Processes) Licensed Product and Product for the Territory, and
(b) Coronado hereby grants to Ovamed the exclusive right and license (with the
right to grant sublicenses) to and under Coronado’s right, title and interest in
any (i) Inventions existing as of the Effective Date or Created solely by
Coronado (including by any employees or consultants of Coronado or agents or
sub-contractors of Coronado that have contractually agreed to assign or
sub-license with sub-licensing rights to Coronado, including under the
Consulting Agreement, their interests in Inventions and intellectual property
rights claiming Inventions), and (ii) Manufacturing Patent Rights (including
rights thereto licensed to Coronado), to make, have made, use, have used, lease,
import, offer to sale, sell and/or have sold (including to practice and have
practiced the Licensed Processes) Licensed Product and Product for the
Ex-Territory. The Parties acknowledge that Inventions Created jointly by the
Parties shall, to the extent applicable, be subject to and governed by the
Collaboration Agreement.

2.3.1 Inventorship for patentable Inventions Created on or after the Effective
Date shall be determined in accordance with the patent laws of the country in
which the patent application is filed (but at a minimum, in accordance with an
individual’s inventive contribution to a claimed Invention) and, except as
specifically set forth in this Second Amendment

 

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or the Collaboration Agreement, ownership of all such Inventions shall flow from
such inventorship determination.

2.3.2 At its sole discretion, the owner of an Invention shall have the initial
right to file, prosecute, and maintain Manufacturing Patent Rights thereon in
such countries worldwide as it may determine. The Party having such initial
right to prosecute and maintain Manufacturing Patent Rights is referred to as
the “Prosecuting Party”. The Party that is not the Prosecuting Party shall
reimburse the Prosecuting Party for patent costs (comprising the reasonable
direct fees and expenses actually paid by the Prosecuting Party to Third
Parties, including attorneys and patent offices, that are specifically
identifiable and incurred for the filing, prosecution, and maintenance of the
specified Manufacturing Patent Rights in accordance with the terms of this
Second Amendment) for Manufacturing Patent Rights in the non-Prosecuting Party’s
territory, upon submission of appropriate invoices therefor. Subject to
Paragraphs 2.3.3 and 2.3.4 below, if a non-Prosecuting Party elects not to
reimburse the Prosecuting Party for such patent costs in a particular country in
such non-Prosecuting Party’s territory, the respective Manufacturing Patent
Right shall no longer be licensed under Section 2.3 to said non-Prosecuting
Party in such country and any such license previously granted shall immediately
terminate.

2.3.3 If the Prosecuting Party elects not to file, prosecute or maintain any
Manufacturing Patent Rights in any country of the non-Prosecuting Party’s
territory, the Prosecuting Party shall so inform the non-Prosecuting Party with
written advance notice sufficient to avoid any loss or forfeiture, and the
Prosecuting Party shall enable the non-Prosecuting Party at the non-Prosecuting
Party’s request, and in that case the non-Prosecuting Party shall have the
right, but not the obligation, to file, prosecute and maintain any such
Manufacturing Patent Rights in such country of the non-Prosecuting Party’s
territory as it may determine at its own expense and discretion. In such event,
at the non-Prosecuting Party’s request, the Prosecuting Party shall assign such
Manufacturing Patent Right to the non-Prosecuting Party, and such Manufacturing
Patent Right shall no longer be deemed a Manufacturing Patent Right of the
original Prosecuting Party in such country, and the original non-Prosecuting
Party shall be deemed the Prosecuting Party for purposes of Paragraph 2.3.4.

2.3.4 The Prosecuting Party agrees to keep the other Party informed of the
course of patent prosecution or other proceedings, including by providing the
other Party with a draft patent application for review sufficiently in advance
of the planned filing date in order for the other Party to have the opportunity
to comment thereon, and shall take such comments into consideration in the
application filed. The Prosecuting Party shall also promptly furnish the other
Party with copies of office actions and communications received by the
Prosecuting Party from, and communications sent by the Prosecuting Party to, the
patent offices concerning such patents or patent application and shall take the
other Party’s comments and suggestions into consideration when framing responses
and submissions to such patent offices. The Prosecuting Party shall timely
inform the other Party of any patent issuing or granting from a patent
application filed hereunder.

2.4 Consulting Agreement. The Parties acknowledge and agree that pursuant to a
consulting agreement between Coronado and TSO Laboratories entered into on the
Second Amendment Effective Date, to be effective as of the date [*] (the
“Consulting Agreement”), in the form attached to this Second Amendment as
Appendix 2.4, TSO Laboratories shall provide the

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

9

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services of [*] to provide consulting services to Coronado. Any and all
confidentiality obligations arisen or arising from [*] employment with Ovamed
shall remain unaffected and are, for the avoidance of doubt, not waived in the
context of Ovamed’s aforementioned agreement to the Consulting Agreement.
Notwithstanding the foregoing, the Parties acknowledge and agree that any such
confidential information of technical nature and relating to Technical
Information or Manufacturing Activities may be disclosed by [*] to Coronado and
used by Coronado subject to the confidentiality agreements between the Parties,
in order to implement the Technology Transfer and the Manufacturing License. For
the avoidance of doubt, [*] shall not be allowed to disclose or use any
financial or business information of Ovamed. Also, for further avoidance of
doubt, the obligations of TSO Laboratories and/or [*] under the Consulting
Agreement shall only be obligations under said Consulting Agreement and shall
not be considered obligations under this Second Amendment and/or any of the
Agreements. Except as regards [*] or as agreed between the Parties in individual
cases, neither Party nor any of their Affiliates shall solicit any employees or
other staff of the other Party or any of said other Party’s Affiliates to work
for it. The foregoing sentence shall also apply with respect to any solicitation
by either Party or any Affiliate of either Party of employees or other staff of
ParaTech.

2.5 Second Source Agreement. The Parties shall negotiate in good faith to enter
into, as soon as practicable after the Second Amendment Effective Date but in
any event no later than [*] after the Second Amendment Effective Date, an
agreement (the “Second Source Agreement”) to be effective as of the
Manufacturing Assumption Date. In addition to the terms set forth in Article 2.1
of the Sublicense Agreement, the Second Source Agreement shall:

2.5.1 provide for Ovamed to have a co-exclusive (with Coronado) right to make
and have made Licensed Product and Product in compliance with the Specifications
and Regulatory Standards for the Territory as a qualified second source supplier
to Coronado in the event of an Coronado Inability to Supply, and for Coronado to
have the co-exclusive (with Ovamed) right and license to make and have made
Licensed Product and Product in compliance with the Specifications and
Regulatory Standards for the Ex-Territory as a qualified second source supplier
to Ovamed in the event of an Ovamed Inability to Supply;

2.5.2 contain provisions for information exchange, technical and quality
control, process improvements, Product presentation, regulatory issues and
addressing costs of compliance with Regulatory Standards applicable to the other
Party’s territory, in each case relating to the manufacturing and supply of
Product under the Second Source Agreement;

2.5.3 provide that the purchase price for Product and placebo supplied under the
Second Source Agreement shall be (a) for clinical supplies, [*]/dose for placebo
and [*]/Unit for Product; and (b) for commercial supplies of Product, [*]/Unit
(whereby each of the foregoing shall be subject to adjustment based on inflation
rates);

2.5.4 contain such other commercially reasonable terms and conditions relating
to the foregoing and consistent with a second source supply agreement for a
product comparable to Product; and

2.5.5 from and after its effectiveness, supersede this Paragraph 2.5.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

10

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2.6 Non-Embryonated TSO Supply Agreement. The Parties shall negotiate in good
faith and use their best efforts to enter into, as soon as practicable after the
Second Amendment Effective Date but in any event not later than [*] after the
Second Amendment Effective Date, an agreement among the Parties and ParaTech,
providing for (i) ParaTech to supply Coronado directly with non-embryonated TSO
manufactured by ParaTech for Coronado’s Manufacturing Activities, on
commercially reasonable terms and conditions no less favorable to Coronado than
those held by Ovamed under the ParaTech Agreement for ParaTech’s manufacture and
supply to Ovamed of non-embryonated TSO, and (ii) purchases of non-embryonated
TSO by Coronado from ParaTech under the Non-Embryonated TSO Supply Agreement to
be aggregated with purchases of non-embryonated TSO by Ovamed from ParaTech
under the ParaTech Agreement for purposes of satisfying any minimum purchase
requirements or realizing any applicable quantity or volume discounts, with each
Party incurring the same average cost per unit for all purchases of
Non-Embryonated TSO in any year (the “Non-Embryonated TSO Supply Agreement”).

2.6.1 Ovamed hereby consents to ParaTech providing and shall request that
ParaTech provide Coronado directly with non-embryonated TSO manufactured by
ParaTech for Coronado’s Manufacturing Activities in accordance with the ParaTech
Agreement and the Non-Embryonated TSO Supply Agreement.

2.6.2 For the avoidance of doubt, Coronado shall not enter into any agreement
for the direct supply of Non-Embryonated TSO by ParaTech to Coronado without
Ovamed being an additional party to the same, nor shall Coronado conduct any
negotiations with ParaTech directly on such agreement without the involvement of
Ovamed, unless Ovamed fails to negotiate in good faith to enter into such
agreement.

2.6.3 Although it is the express intention and agreement as between the Parties
to enter into the Non-Embryonated TSO Supply Agreement with ParaTech, if for any
reason they are unable to do so, Ovamed shall supply Coronado with
non-embryonated TSO purchased by Ovamed under the ParaTech Agreement at costs
price (i.e., on the same terms and conditions as Ovamed purchases such
non-embryonated TSO from ParaTech plus shipment, handling and packaging costs
only), and the Parties shall enter into a separate supply agreement to such
effect.

2.6.4 From and after its effectiveness, the Non-Embryonated TSO Supply Agreement
shall supersede this Paragraph 2.6.4.

2.7 Lease Assignment. Simultaneously with the execution and delivery of this
Second Amendment, Ovamed will assign, or will cause TSO Laboratories to assign,
to Coronado and Coronado will assume the Lease, in accordance with the form of
Assignment and Assumption of Lease attached to this Second Amendment as Appendix
2.7. Coronado will reimburse Ovamed for the actual out-of-pocket expenses
incurred by Ovamed and/or TSO Laboratories through the Second Amendment
Effective Date in connection with the negotiation of the Lease and the
establishment of the US Facility, as evidenced by a schedule of such costs
provided by Ovamed to Coronado prior to the Second Amendment Effective Date, of
US$36,250.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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3. Amendments to the Agreements. The Parties hereby agree to the following
amendments to the Agreements:

3.1 Sublicense Agreement Amendments as of Second Amendment Effective Date. The
Sublicense Agreement, as amended and in effect immediately prior to the Second
Amendment Effective Date, is hereby amended effective as of the Second Amendment
Effective Date, as follows:

3.1.1 Article 1.6 (including Sections 1.6.1 through 1.6.3 thereof) is hereby
amended and restated to read in its entirety as follows:

“1.6 “Net Sales” means the total gross receipts for sales of Licensed Products
and, for purposes of calculating the Manufacturing Fee, Products, by or on
behalf of the Company or its Affiliates or Company Sublicensees (as applicable),
whether invoiced or not, less only the sum of the following: (a) usual trade
discounts to customers; (b) sales, tariff duties and/or taxes directly imposed
and with reference to particular sales; (c) amounts allowed or credited on
returns or rejections; (d) bad debt deductions actually written off during the
accounting period; (e) outbound transportation prepaid or allowed and
transportation insurance; and, however only as regards the calculation of
royalties but not the Manufacturing Fee, (f) sales commissions and (g) packaging
and freight charges.

1.6.1 Notwithstanding anything to the contrary in this Article 1.6, Net Sales
does not include sales of (a) Licensed Product or Product at or below the fully
burdened cost of manufacturing solely for non-profit research or clinical
testing or for indigent or similar public support or compassionate use programs,
or (b) solely for purposes of calculating the Manufacturing Fee, Product
manufactured by Ovamed or its Affiliates. If (i) the end user is a Company
Sublicensee or an Affiliate or (ii) Licensed Product, Product or Licensed
Process is sold for consideration other than money, then Net Sales shall be
calculated based on the final gross selling price of comparable Licensed
Products or Products sold in arm’s length transactions by Company to an end
user.

1.6.2 For purposes of determining Net Sales, Licensed Product and Product, as
applicable, shall be deemed to be sold when shipped or to be the subject of a
sale upon the delivery of Licensed Product or Product, respectively, to the
purchaser or a common carrier at the risk of the purchaser and the transfer of
title thereto to the purchaser.

1.6.3 Sales between or among (a) the Company and Ovamed, and/or (b) the Company
and any of the Company’s or Ovamed’s respective licensees, Sublicensees or
Affiliates, shall be excluded from the computation of Net Sales provided such
parties are not the end-user of the products, but sales by the Company’s
licensees, Sublicensees or Affiliates to their non-affiliated customers shall be
included in such computation.”

3.1.2 Article 2.1 is hereby amended and restated to read in its entirety as
follows:

“2.1 Subject to the terms and conditions of this Agreement, Ovamed hereby grants
to the Company and the Company accepts an exclusive (even as to Ovamed, except
as set forth herein) right and license (and sublicense) in the Field (with the
right to grant sublicenses to

 

12

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Affiliates and/or to third parties in accordance with Article 2.2 below), under
the Patent Rights, the Technical Information and the Know-How, to make, have
made, use, have used, lease, import, offer to sale, sell and/or have sold
(including to practice and have practiced the Licensed Processes) Licensed
Product and Product for the Territory. The rights and licenses granted by Ovamed
to the Company under this Article 2.1 to make Licensed Product and Product under
the Patent Rights and Know-How are referred to herein as the “Manufacturing
License”.

2.1.1 Notwithstanding the foregoing, prior to the Manufacturing Assumption Date,
(a) Ovamed shall have the co-exclusive (with Company) right to make, and the
exclusive right and obligation to supply Company with, Licensed Product and
Product for the Territory pursuant to the terms of the Supply Agreement, and
(b) Company shall not make Licensed Product or Product for commercial
distribution in the Territory.

2.1.2 In accordance with the Second Amendment and the Second Source Agreement,
(a) Ovamed shall have the co-exclusive (with Company) right to make and have
made Licensed Product and Product in compliance with the Specifications and
Regulatory Standards for the Territory as a qualified second source supplier to
Company in the event of a Company Inability to Supply, and (b) the Company shall
have the co-exclusive (with Ovamed) right and license to make and have made
Licensed Product and Product in compliance with the Specifications and
Regulatory Standards for the Ex-Territory as a qualified second source supplier
to Ovamed in the event of an Ovamed Inability to Supply”.

3.1.3 Article 4.3 is hereby amended to add the following sentence to the end
thereof:

“Except as otherwise specifically set forth herein, the Milestone Payments shall
be paid within ten (10) business days after achievement of the applicable
milestone event”.

3.1.4 Article 4.6 is hereby amended and restated in its entirety to read as
follows:

“4.6 Royalty, Manufacturing Fee and other payments hereunder shall be paid in
United States dollars at such place or to such entity as Ovamed may reasonably
designate consistent with the laws and regulations controlling in the United
States and if applicable in any foreign country (provided such designation would
not require any increase in the amount of any such payment hereunder). Any taxes
which the Company, its Affiliate or any Company Sublicensee shall be required by
law to withhold on remittance of the royalty, Manufacturing Fee, or other
payments shall be deducted from such royalty, Manufacturing Fee or other payment
to Ovamed. The Company shall furnish Ovamed with the original copies of all
official receipts for such taxes. Ovamed (or Ovamed’s designated payee) shall
provide the Company as required by law, with all forms or documentation required
by any applicable taxation laws, treaties or agreements to such withholding or
as necessary to claim a benefit thereunder (including, but not limited to Form
W-8BEN or any successor forms). If any currency conversion shall be required in
connection with the payment of royalties, Manufacturing Fees or other payments
hereunder, such conversion shall be made by using the exchange rate prevailing
at Citibank, N.A. in New York, New York on the last business day of the calendar
quarterly reporting period to which such payments relate.”

 

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3.1.5 Article 4.7 is hereby deleted and restated in its entirety to read as
follows:

“4.7 The Company shall also pay Ovamed during the term of this Agreement an
amount with respect to Products manufactured by the Company and included in Net
Sales (the “Manufacturing Fee”), determined and payable in accordance with and
subject to the Manufacturing Fee Adjustment, the Manufacturing Fee Credit and
the Transfer Fee Buy-Down Right as set forth in this Article 4.7.

4.7.1 Manufacturing Fee. The Manufacturing Fee for each calendar quarter shall
equal the greater of the amount (a) equal to [*] percent ([*]%) of Net Sales (of
Products manufactured by the Company) in such calendar quarter (the “Royalty
Component”) or (b) calculated by multiplying [*] (the “Transfer Fee Component”)
by the aggregate number of Units of Product included in Net Sales (and
manufactured by the Company) in such calendar quarter. The Manufacturing Fee
shall be payable quarterly in accordance with Article 5.2, provided, however,
that in the event for any calendar year the provisions of Section 4.7.2 are
applicable, the Manufacturing Fee payable for the fourth calendar quarter of
such calendar year (and, to the extent necessary to fully credit the
Manufacturing Fee Adjustment, as defined and provided for in Section 4.7.2, the
immediately subsequent calendar quarters) shall give effect to the Manufacturing
Fee Adjustment for such calendar year.

4.7.2 Manufacturing Fee Adjustment.

(a) If for any Adjustment Eligible Year (as defined below), Coronado Per Unit
Manufacturing Costs (as evidenced by the Company’s written records) for Products
manufactured by the Company and included in Net Sales in such year exceed [*]
per Unit of such Product (such [*], the “Manufacturing Costs Cap”), then:
(i) until such time as the Company exercises the Transfer Fee Buy-down Right,
the Manufacturing Fee calculated in accordance with Article 4.7.1 shall be
reduced by the amount by which Coronado Per Unit Manufacturing Costs exceed the
Manufacturing Costs Cap, and (ii) after the exercise of the Transfer Fee
Buy-Down, the Royalty Component shall be reduced by the amount by which Coronado
Per Unit Manufacturing Costs exceed the Manufacturing Costs Cap; in each case
subject to the provisions of Article 4.7.2 (b). An “Adjustment Eligible Year”
means any calendar year in which (x) Net Sales included at least [*] Units of
Product, and (y) at least [*] were used in connection with the manufacture of
Products included in Net Sales. If the provisions of this Article 4.7.2(a) are
applicable, the Company shall set forth in its report under Article 5.2 for the
fourth calendar quarter of such year, the calculation of the reduction in the
Manufacturing Fee for such calendar year. Any such reduction in the
Manufacturing Fee determined in accordance with this Article 4.7.2 is referred
to herein as the “Manufacturing Fee Adjustment”.

(b) The Manufacturing Fee Adjustment shall not be applicable in an Adjustment
Eligible Year in which (i) the Ovamed Per Unit Manufacturing Costs did not
exceed the Manufacturing Costs Cap, as evidenced by Ovamed’s written records;
(ii) Ovamed, within fifteen (15) days after receipt of a report under Article
5.2 setting forth a Manufacturing Fee Adjustment, advises the Company in writing
thereof; and (iii) Ovamed, within fifteen (15) days after providing such notice
under (ii), provides the Company with such written records. However, if the
Company

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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does not agree with Ovamed’s position, the Parties shall negotiate in good faith
to reach a mutually acceptable resolution based on the relevant facts and
circumstances in a manner that comes closest to achieving the overall intent,
purposes and agreements between the Parties as set forth in this Article 4.7.

(c) In the event an Adjustment Eligible Year occurs when inflation has exceeded
[*] percent ([*]%) per year for each year commencing as of January 1, 2013, the
Parties shall negotiate in good faith to reach a mutually acceptable resolution
as to whether the Manufacturing Costs Cap should be adjusted, based on the
relevant facts and circumstances, in a manner that comes closest to achieving
the overall intent, purposes and agreements between the Parties as set forth in
this Article 4.7.

4.7.3 Transfer Fee Buy-Down Right

(a) The Company shall have the right (the “Transfer Fee Buy-down Right”),
exercisable by providing written notice of such election to Ovamed not later
than ten (10) business days following the receipt of the first written final
approval by the FDA of a Biologics License Application approving the
manufacturing, marketing and commercial sale of Licensed Product in the United
States (the “Initial Regulatory Approval”), to reduce the Transfer Fee Component
to [*] per Unit.

(b) In the event the Company exercises the Transfer Fee Buy-down Right (i) all
references herein to the Transfer Fee Component from and after the exercise date
shall mean [*] per Unit (such that, subject to the other provisions of this
Article 4.7, the Manufacturing Fee for each calendar quarter shall equal the
greater of (x) the Royalty Component (subject to the Manufacturing Fee
Adjustment), or (y) the amount calculated by multiplying [*] by the aggregate
number of Units of Product included in Net Sales (and manufactured by the
Company) in such calendar quarter); and (ii) the Company shall make the
following additional one-time milestone payments to Ovamed: (A) seven million
five hundred thousand dollars (US$7,500,000) within ten (10) business days after
the date of Initial Regulatory Approval, and (B) twelve million five hundred
thousand dollars (US$12,500,000) within ninety (90) days after the end of the
first calendar year in which Net Sales in the Territory exceed two hundred fifty
million dollars (US$250,000,000).

4.7.4 Renegotiation of Manufacturing Fee. In the event (a) the Company has
exercised the Transfer Fee Buy-down Right, and (b) of the introduction in the
United States of a Competing Product, or if the annual treatment dosage of
Product approved by the FDA is higher than that set forth in the definition of
Unit herein, or of other circumstances beyond the Company’s control, such as
market conditions, healthcare regulations or reimbursement issues, and (c) for
any calendar quarter the Company’s Gross Margin is less than [*]%, the Parties
shall negotiate in good faith in a reasonable and mutually acceptable manner to
adjust the Manufacturing Fee (and amend this Agreement to reflect such
adjustment) effective for and after such calendar quarter, to substitute
provisions that come closest to achieving the overall intent, purposes and
agreements between the Parties as set forth in Article 4.7 of this Agreement.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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4.7.5 Manufacturing Fee Credit. Ovamed shall give the Company a credit to be
applied to the Manufacturing Fee, said credit not to exceed (a) Three Million
Dollars (US$3,000,000) less (b) the sum of the credits previously applied under
Section 7.2 of the Supply Agreement against the purchase price for clinical
supplies of Product purchased by the Company from OvaMed under the Supply
Agreement (the “Manufacturing Fee Credit”), up to the aggregate amount of the
Manufacturing Fee Credit.”

3.1.6 The first sentence of Article 4.8 is hereby deleted in its entirety and is
hereby replaced with the following three sentences:

“4.8 Commencing on December 12, 2009 and on each anniversary of such date during
the term of the License Agreement, the Company shall pay Ovamed (or at the
Company’s option, UIRF directly) an annual license maintenance fee of Two
Hundred Fifty Thousand Dollars (US$250,000). In addition, the Company shall pay
Ovamed an aggregate of one million five hundred thousand dollars (US$1,500,000),
payable in three installments of Five Hundred Thousand Dollars (US$500,000) each
on December 12, 2014, December 12, 2015 and December 12, 2016, as compensation
for Ovamed not maintaining its position of being the exclusive supplier of
Product to the Company as a consequence of Ovamed granting to the Company the
Manufacturing License. As a result, the total amounts to be paid under the
preceding two sentences of this Article 4.8 on each of December 12, 2014, 2015
and 2016 shall amount to Seven Hundred Fifty Thousand Dollars (US$750,000).”

3.1.7 Article 5.1 is hereby amended and restated to read in its entirety as
follows:

“5.1 The Company shall report to Ovamed the date of first sale by or on behalf
of the Company or its Affiliates or Company Sublicensees (“First Commercial
Sale”) of Licensed Products or Products (or results of Licensed Processes) in
each country within thirty (30) days of occurrence.”

3.1.8 Article 5.2 is hereby amended and restated to read in its entirety as
follows:

“5.2 Commencing in the calendar quarter in which the First Commercial Sale of
Licensed Product or Product occurs in the Territory, the Company agrees to
submit to Ovamed within sixty (60) days after the calendar quarters ending
March 31, June 30, September 30, and December 31, reports setting forth for the
preceding calendar quarter at least the following information: (i) the number of
Units included in Net Sales for such calendar quarter that were manufactured by
the Company, (ii) the number of the Licensed Products and/or Products sold by
the Company, its Affiliates and Company Sublicensees in each country in the
Territory; (iii) total gross sales for such Licensed Products and/or Products;
(iv) deductions applicable to determine the Net Sales; (iv) the amount of
royalty due thereon; and (v) the Manufacturing Fee, setting forth the Royalty
Component and the Transfer Fee Component and, if applicable, any Manufacturing
Fee Credit applied in such calendar quarter. If no royalties or Manufacturing
Fees are due to Ovamed for any reporting period, the written report shall so
state. Each report shall be accompanied by the royalty and the Manufacturing Fee
due. In addition, if for any Adjustment Eligible Year there is a Manufacturing
Fee Adjustment in accordance with Article 4.7, the Company shall set forth in
the report for the calendar quarter ending December 31 of such year the
Manufacturing Fee Adjustment

 

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and the calculation thereof. In such event, the payment of the Manufacturing Fee
for such quarter ending December 31 (and, to the extent necessary to fully
credit the Manufacturing Fee Adjustment, the immediately subsequent calendar
quarters) shall give effect to the Manufacturing Fee Adjustment applicable to
the year then ended, provided that Ovamed shall have the rights with respect
thereto set forth under Article 4.7.2(b).”

3.1.9 Article 9.1 paragraph (a) is hereby amended and restated to read in its
entirety as follows:

“(a) Ovamed’s right to receive or recover and the Company’s obligation to pay
royalties and/or Manufacturing Fees accrued or accruable for payment at the time
of termination;”

3.1.10 Article 9.6 is hereby amended and restated to read in its entirety as
follows:

“9.6 The Company shall have the right to terminate this Agreement by giving
thirty (30) days advance written notice to Ovamed (a) at any time prior to the
date of the last to expire valid claim contained in the Patent Rights; (b) if
the Company determines in good faith that it is not advisable for the Company to
develop, manufacture, market or sell Licensed Product or Product in the
Territory as a result of any actual or perceived safety issue regarding the
Licensed Product or Product; or (c) in the event of a Competing Product in the
United States. In the event of such termination by the Company, the Company’s
rights to use any rights, including under the Technical Information (unless and
to the extent any such Technical Information has become publicly known),
licensed from Ovamed hereunder, shall terminate. In addition, in the event of
termination by the Company und either sub-section (a) or (b), the Company shall
cease and desist from manufacturing and/or selling and/or otherwise
commercializing any Products for a period of five (5) years from the date such
termination becomes effective. Upon termination, a final report shall be
submitted and any royalty and Manufacturing Fee payments and unreimbursed patent
expenses due to Ovamed shall become immediately payable.”

3.1.11 Article 9.7 is hereby deleted and restated to read in its entirety as
follows:

“9.7 Intentionally left blank”

3.1.12 Article 9.9 is hereby deleted and restated to read in its entirety as
follows:

“9.9 If not terminated sooner in accordance with the preceding provisions, this
Agreement shall terminate on the later of (i) the date of the last to expire
valid claim contained in the Patent Rights in the United States, and (ii) 15
years from the First Commercial Sale in the United States, provided, however,
that the Company’s obligations to pay royalties, payments on NRSI and Milestone
Payments, and the specific provisions of Articles 4.2 through 4.5 and related
provisions and corresponding reporting etc. obligations (but, for the avoidance
of doubt, not the Company’s obligation under Article 4.7 to pay Manufacturing
Fees) shall terminate on the date of the last to expire valid claim contained in
the Patent Rights.”

 

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3.1.13 Article 10.1 is hereby amended to add the following sentence to the end
thereof:

“This Agreement shall be binding upon and inure to the benefit of the successors
and permitted assigns of the Parties.”

3.2 Sublicense Agreement Amendment as of the Manufacturing Assumption Date.
Effective as of the Manufacturing Assumption Date, Article 3.2 of the Sublicense
Agreement, as amended and in effect immediately prior to the Manufacturing
Assumption Date, shall be deleted in its entirety.

3.3 Termination of Certain Obligations and Agreements. Effective as of the
Manufacturing Assumption Date, (a) Paragraph 2 of the Letter Agreement shall
terminate in its entirety and shall have no further force and effect, and the
obligations therein shall be deemed fulfilled or waived, and (b) the Supply
Agreement shall terminate in its entirety and the obligations therein shall be
deemed fulfilled or waived, except that the following provisions of the Supply
Agreement shall survive such termination and remain in full force and effect:
(i) Article 8.3 (Survival), in accordance with its terms, (ii) Article 7.2
(Milestone Credits), solely to calculate the amount of credits previously
provided under such Article 7.2 for purposes of implementing Article 4.7.5 of
the Sublicense Agreement; and (iii) any other provisions of the Supply Agreement
relating to the rights and obligations of the Parties as in effect immediately
prior to the Manufacturing Assumption Date with respect to (i) any then
unfulfilled Purchase Orders submitted by Coronado prior to the Manufacturing
Assumption Date, or (ii) Product supplied by Ovamed prior to the Manufacturing
Assumption Date, in accordance with their respective terms.

4. Representations and Warranties.

4.1 Ovamed hereby represents and warrants to Coronado (by way of an independent
warranty under German law, “Represents and Warrants”) that:

4.1.1 as of the Second Amendment Effective Date, the License Agreement is in
full force and effect in accordance with its terms and there have been no
amendments thereto that have not been provided to Coronado; Ovamed is not in
default or breach of the License Agreement nor has it received any notice of any
defaults, breaches or violation thereunder and, to the best of Ovamed’s
knowledge, UIRF is not in default or breach of such agreement;

4.1.2 as of the Second Amendment Effective Date, the ParaTech Agreement is in
full force and effect in accordance with its terms and there have been no
amendments thereto that have not been provided to Coronado; Ovamed is not in
default or breach of the ParaTech Agreement nor has it received any notice of
any defaults, breaches or violation thereunder and, to the best of Ovamed’s
knowledge, ParaTech is not in default or breach of such agreement; the
execution, delivery and performance of this Second Amendment, including the
grant by Ovamed of the rights and licenses hereunder and under the Agreements as
amended by this Second Amendment, will not violate, be in conflict with,
constitute a default (or an event which, with notice or lapse of time or both,
would constitute a default) under, result in the termination of, or require any
consents under the ParaTech Agreement;

 

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4.1.3 as of the Second Amendment Effective Date, Ovamed is not in default or
breach of the Lease nor has it received any notice of any defaults, breaches or
violation thereunder and, to the best of Ovamed’s knowledge, the lessor
thereunder is not in default or breach of the Lease;

4.1.4 TSO Laboratories is a wholly-owned subsidiary of Ovamed and is a
corporation organized under the laws of the state of Massachusetts;

4.1.5 all Technical Information and other information, documentation and other
materials furnished or made available by Ovamed to Coronado in connection with
the Technology Transfer are and will be true, complete, and correct in all
material respects; and

4.1.6 as of the Second Amendment Effective Date, Ovamed does not own, control or
have any rights, licenses or interests in, to or under any Manufacturing Patent
Rights.

4.2 Coronado hereby represents and warrants to Ovamed (by way of an independent
warranty under German law, “Represents and Warrants”) that as of the Second
Amendment Effective Date Coronado does not own, control or have any rights,
licenses or interests in, to or under any Manufacturing Patent Rights.

4.3 Each Party hereby represents and warrants to the other Party hereto that:

4.3.1 Such Party has the requisite corporate power and authority to execute and
deliver this Second Amendment, perform its obligations hereunder, and consummate
the transactions contemplated hereby; the execution, delivery and performance of
this Second Amendment have been duly and validly authorized and no other
corporate proceedings are necessary to authorize this Second Amendment or the
performance hereof or thereof by such Party;

4.3.2 This Second Amendment has been duly and validly executed and delivered by
such Party and, assuming due authorization, execution and delivery by the other
Party, constitutes the valid and binding obligations of such Party, enforceable
against such Party in accordance with its terms; and

4.3.3 There are no contracts, agreements or other arrangements between such
Party and any third party that is in conflict with, or that could reasonably be
anticipated to have an impact in any respect upon the rights and licenses
granted to the other Party under this Second Amendment, and such Party has
obtained all authorizations, consents and approvals necessary for the execution,
delivery and performance of such Party’s agreements and obligations under this
Second Amendment.

5. Other.

5.1 From and after the Second Amendment Effective Date, all references to any of
the Agreements shall mean such Agreement(s) as amended and in effect from and
after the Second Amendment Effective Date in accordance with the terms of this
Second Amendment. From and after the Manufacturing Assumption Date, all
references to any of the Agreements shall mean such Agreement(s) as amended and
in effect from and after the Manufacturing Assumption Date in

 

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accordance with the terms of this Second Amendment. Except as amended or
terminated by this Second Amendment, the Agreements shall remain in full force
and effect.

5.2 From and after the Second Amendment Effective Date, in the event of any
ambiguity interpreting any term or provision of this Second Amendment or any of
the Agreements whether or not as a result of this Second Amendment, the Parties
shall in good faith interpret such term or provision in a reasonable and
mutually acceptable manner to be consistent with the remaining terms and
provisions and the overall intent and purposes of this Second Amendment.

5.3 If any term or provision of this Second Amendment, or any of the Agreements
as amended by this Second Amendment, is determined to be invalid or enforceable,
the remainder of this Second Amendment or Agreement so amended shall remain in
effect and the Parties covenant and agree to renegotiate in good faith any such
term or provision in order to provide a reasonably and mutually acceptable
alternative to the term or provision that is invalid or unenforceable,
consistent with the remaining terms and provisions and the overall intent and
purposes of this Second Amendment.

5.4 This Second Amendment, the Agreements, the rights of the Parties, and all
claims arising under or in connection herewith shall be governed by and
interpreted in accordance with the substantive laws of Germany without regard to
conflict of laws principles that would cause the application of the laws of
another jurisdiction. The Parties irrevocably submit to the exclusive
jurisdiction of the courts of Hamburg, Germany, for the purpose of any claim,
controversy, action, cause in action, suit or litigation, including for tortuous
claims, between the Parties arising in whole or in part under or in connection
with this Second Amendment and/or the Agreements.

5.5 Except as otherwise stated, all references herein to an Appendix mean the
specified Appendix to this Second Amendment. This Second Amendment, including
the Appendices hereto, contains the entire understanding of the Parties with
respect to the subject matter of this Second Amendment. All express or implied
agreements and understandings, either oral or written, made on or before the
Second Amendment Effective Date, including any correspondence, emails or term
sheets, are expressly superseded by this Second Amendment. This Second Amendment
may be amended, or any term hereof modified, including this Paragraph 5.5, only
by a written instrument duly executed by the Parties.

5.6 This Second Amendment may be executed in two or more counterparts, each of
which shall be deemed an original but all of which together shall constitute one
and the same instrument. Signatures to this Second Amendment transmitted by fax,
by email in “portable document format” (“.pdf”) or by any other electronic means
intended to preserve the original graphic and pictorial appearance of this
Second Amendment shall have the same effect as physical delivery of the paper
document bearing original signature.

5.7 All notices, requests and other communications hereunder or under any of the
Agreements shall be in writing and shall be personally delivered or sent by fax
transmission (and promptly confirmed by personal delivery, registered or
certified mail or overnight courier) or by registered or certified mail, return
receipt requested, postage prepaid, or sent by internationally-recognized
overnight courier, in each case to the respective address specified below, or
such other address as may be specified in writing to the other Party hereto:

 

20

--------------------------------------------------------------------------------

if to Coronado:

Coronado Biosciences, Inc.

24 New England Executive Park

Burlington, MA 01803

Attention: Chief Operating Officer

Fax No.: [*]

Email: [*]

if to Ovamed:

Ovamed GmbH

Kiebitzhörn 31

22885 Barsbuttel, Germany

Attention: General Manager, (CEO), Mr. Alexander Beese

Fax No.: [*]

Email: [*]

IN WITNESS WHEREOF, the Parties have executed this Second Amendment as of the
Second Amendment Effective Date.

 

Ovamed GmbH

By:

 

/s/ Alexander Beese

  Name: Alexander Beese   Title: General Manager (CEO)

By:

 

/s/ Detlev Goj

  Name: Detlev Goj   Title: General Manager (COO)

 

Coronado Biosciences, Inc.

By:

 

/s/ Bobby W. Sandage

  Name: Bobby W. Sandage, Jr., Ph.D   Title: President and Chief Executive
Officer

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

21

--------------------------------------------------------------------------------

Appendix 1.5

Manufacturing Costs

--------------------------------------------------------------------------------

SECOND AMENDMENT AND AGREEMENT

Appendix 1.5 (a)

Included Cost Categories

Materials: TSO and other ingredients and manufacturing supplies

Costs and maintenance of manufacturing equipment and tools

Costs of labor involved in Manufacturing Activities

Subcontracted services and regulatory fees

Other expenses, including : facilities rent, leasehold improvements, utilities

and maintenance, insurance and information technology

--------------------------------------------------------------------------------

SECOND AMENDMENT AND AGREEMENT

Appendix 1.5 (b)

Excluded Cost Categories

All costs of, or related to, corporate officers

Allocation of non-manufacturing overheads

Product liability insurance

Milestones and amortization thereof

--------------------------------------------------------------------------------

Appendix 1.25

Technical Information

 

23

--------------------------------------------------------------------------------

Appendix 1.25 to Second Amendment and Agreement between Coronado and Ovamed:

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

Appendix 2.4

Consulting Agreement

 

24

--------------------------------------------------------------------------------

Execution Copy

CONSULTING AGREEMENT

This Consulting Agreement (“Agreement”), dated as of the 21st day of December,
2012, is entered into by and between TSO LABORATORIES, INC., a Massachusetts
corporation having offices at 355 Providence Highway, Suite 200, Westwood, MA
02030 (hereinafter referred to as “Consultant”) and CORONADO BIOSCIENCES, INC.,
a Delaware corporation having offices at 24 New England Executive Park, Suite
105, Burlington, MA 01803 (hereinafter referred to as “Company”). Consultant and
Company are sometimes individually referred to herein as a “Party” and
collectively as the “Parties”.

WHEREAS, on the date hereof, the Company and Ovamed GmbH, the sole shareholder
of Consultant (“Ovamed”), have entered into a Second Amendment and Agreement
(the “Second Amendment”) pursuant to which, among other things, Ovamed has
granted the Company a Manufacturing License (as defined in the Second
Amendment), agreed to Technology Transfer (as defined in the Second Amendment)
obligations, and agreed to cause Consultant to enter into this Agreement; and

WHEREAS, Consultant has agreed to provide the services of [*] (“[*]”) to perform
Consultant’s obligations under this Agreement.

In consideration of the foregoing and the mutual covenants as set forth below,
and for other good and valuable consideration, the Parties named above agree as
follows:

1. Engagement. Company shall engage Consultant during the Term to make [*], as
an employee of Consultant, available to the Company on a full time basis to
render and perform on Consultant’s behalf the technical, advisory and other
consulting services set forth herein (the “Services”), and Consultant accepts
such engagement by Company to make [*] available to render and perform such
Services on the terms and conditions set forth herein. [*], by executing this
Agreement, has agreed to render and perform on Consultant’s behalf and on a full
time basis the Services required to be performed by Consultant hereunder, and
has agreed to the agreements, obligations and other provisions herein
specifically applicable to [*], all on the terms and conditions set forth
herein.

2. Services.

(a) General. The Services shall comprise assisting the Company in establishing a
manufacturing facility in Woburn, MA for conducting Manufacturing Activities (as
defined in the Second Amendment) and may include the following:

 

  •  

Manufacturing facility planning, design, engineering, equipment and capital and
lease build-out improvements;

 

  •  

Manufacturing process initialization, operations and efficiencies;

 

  •  

Materials handling and supply chain management;

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

  •  

Documentation, technology, systems and support;

 

  •  

Training employees of Company and establishing training documentation in
connection with Manufacturing Activities;

 

  •  

Assisting in the preparation of regulatory submissions, including the CMC
Amendment; and

 

  •  

Other services related to the Manufacturing Activities as requested by the
Company.

(b) Manner of Performance and Records. [*] shall work closely with Company’s
personnel as required by the nature of the Services. [*] primary contact for
Services will be the Company’s plant manager or such other person designated by
the Company. [*] shall make available to Company periodically upon request, work
products and other information produced by [*] as may be necessary to enable
Company to verify that [*] is proceeding in accordance with any specified and
completion dates and general specifications for Services. While at any of the
facilities of Company, [*] shall observe and follow the work rules, policies and
standards of Company including but not limited to Company’s rules, policies and
standards relating to security of and access to Company’s facilities, telephone
systems, electronic mail systems, computer systems, confidential information and
intellectual property. [*] shall perform all Services in a professional manner,
consistent with industry standards and in accordance with all applicable laws,
rules, or regulations. [*] shall keep records including any operational
documentation pertaining to the Services, records relevant to any costs or
expenses incurred by [*] in performing Services, and any financial records,
procedures and other documentation pertaining to [*] performance under this
Agreement. [*] shall preserve all such records in accordance with the record
retention periods contained in Company’s records retention and management
policies and in accordance with any applicable federal, state or local
requirements.

3. Compensation.

(a) Fees. As full compensation for Consultant’s performance of Services by [*]
during the Term, Company will pay Consultant a monthly consulting fee of twenty
thousand dollars (US$20,000), payable on or around the fifteenth (15th) day of
each month (and pro rated for any partial monthly period during the Term).

(b) Expenses. Company shall also reimburse Consultant for all actual and
reasonable (coach airfare) out of pocket travel expenses incurred by [*] in
performing Services during the Term, provided such travel is approved in advance
by Company and appropriate documentation (including original receipts) is
provided for such expenses.

(c) Temporary Housing, Car and En-Route Expenses. Company shall also provide
[*], for a period of up to three (3) months from the Effective Date, with the
use of and pay for expenses associated with (i) a rental car, and (ii) temporary
housing for [*], his spouse and his dependents near the manufacturing facility,
provided, however, that the foregoing obligations shall terminate in the event
of and at the time of [*] relocation of his residence to Massachusetts. Company
shall also arrange and pay for one-way coach airfare for [*], his spouse and his
dependents to travel from Germany to Boston.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

4. Assignment of Inventions and Work Product.

(a) For so long as [*] remains a [*] of Ovamed, [*] will promptly make full
written disclosure to both Company and Ovamed and hereby assigns, transfers and
conveys to Company (or its designee) and Ovamed to own jointly, all of [*]
worldwide right, title and interest in and to any and all inventions, whether or
not patentable, that [*] may solely or jointly create, conceive, develop, or
reduce to practice, or cause to be conceived or developed or reduced to
practice, in the performance of the Services (collectively, the “Inventions”),
including any and all intellectual property rights inherent in or claiming the
Inventions and appurtenant thereto including, without limitation, all patent
rights (collectively, “Intellectual Property Rights”) with each of Company (or
its designee) and Ovamed having an undivided interest in such jointly-owned
Invention in accordance with the joint ownership rules of applicable patent
laws. From and after the date that [*] is no longer a [*] of Ovamed, [*] will
promptly make full written disclosure to Company and hereby assigns, transfers
and conveys solely to Company (or its designee) all of [*] worldwide right,
title and interest in and to any and all Inventions, including any and all
Intellectual Property Rights, all of which will be owned solely by Company. Each
Party’s right, title and interest in any Inventions and Intellectual Property
Rights, including any jointly-owned Inventions and Intellectual Property Rights,
shall also be subject, to the extent applicable, to (i) the provisions of
Paragraph 2.3 of the Second Amendment, and (ii) each Party’s rights and
obligations under the Collaboration Agreement (as defined in the Second
Amendment) which, to the extent inconsistent or in conflict with any of the
provisions of such Paragraph 2.3, shall control.

(b) Consultant and [*] further acknowledge and agree that all original works of
authorship and work product developed or generated by Consultant or [*] in the
performance of Services or that result, to any extent, from use of Company’s
premises or property including, but not limited to, papers, records, reports,
analyses, trade secrets, computer based information and drawings, proposals,
information or similar ideas or matters or deliverables (other than any of the
foregoing that constitute Inventions, which are covered in Paragraph 4(a) above)
(collectively “Work Product”) and all rights, title and interest in and to any
such Work Product will be the sole and exclusive property of Company, and all of
which shall be deemed Company Confidential Information as defined in Section 5
herein. [*] hereby assigns, transfers and conveys to Company all of his
worldwide right, title and interest in and to such Work Product, including all
copyrights, trademarks and other intellectual property rights therein and
appurtenant thereto.

(c) Each of Consultant and Ovamed hereby agree to [*] agreements and obligations
in this Paragraph 4 and represents, warrants and covenants that neither it nor
any of its affiliates is, as of the Effective Date, or will become, during the
Term, a party to any employment or other agreement with [*] that is inconsistent
or in conflict with such agreements and obligations.

5. Confidential Information. In consideration of the willingness of Company to
disclose and/or to provide Consultant certain proprietary and confidential
information of Company, including, but not limited to, information relating to
scientific or technical information, data, formulas or related concepts,
business plans or financial documentation, research and development operations,
products, proposed products, know-how, protocols, protocol synopsis, pricing,
manufacturing processes, trade secrets or any other confidential or

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

proprietary information, including information of any third party to whom
Company owes a duty of confidentiality, whether written or oral (herein
“Confidential Information”), and in recognition of the confidential nature
thereof, each of Consultant and [*], intending to be legally bound, hereby
agrees not to use or disclose any Confidential Information to any person or
entity without the prior consent of Company. Each of Consultant and [*] will use
best efforts to safeguard any Confidential Information and to prevent any such
information from being disclosed to any unauthorized person or entity and shall
promptly notify Company’s management should any unauthorized disclosure of
Confidential Information occur.

(a) The foregoing obligations of confidentiality shall not apply to any
Confidential Information which:

(i) is or subsequently becomes part of the public domain through no fault of
Consultant or [*];

(ii) is received from a third party under no obligation of confidentiality to
Company, as established by written records;

(iii) was known to Consultant or [*] at the time of disclosure and such prior
knowledge can be demonstrated in its records to have been independently
developed, without breach of this Agreement and/or use of the Confidential
Information; or

(iv) is disclosed pursuant to a court order, administrative agency, or other
governmental body or is otherwise required by law to be disclosed; provided,
however, that the receiving party shall make the best effort to provide prompt
notice of such court order or requirement to the disclosing party to enable the
disclosing party to seek a protective order or otherwise prevent or restrict
such disclosure.

(b) The obligations of confidentiality and non-use shall apply for a period of
ten (10) years from the date of termination of this or any successor agreement.

(c) Confidential Information shall remain the property of the Company. This
Agreement shall in no way be construed as the granting of a license by Company
to Consultant directly or indirectly, under any patent or patent application or
other intellectual property rights owned or controlled by Company. Any and all
documents furnished by Company to the Consultant shall be returned upon the
request of the Company and in any event upon termination of this Agreement.
Consultant shall, upon request (except as may be prohibited by law, or legal,
judicial, or regulatory process or pursuant to any requirement of any regulatory
body having jurisdiction over the receiving party or its representatives)
promptly deliver to Company (or destroy and certify such destruction to the
disclosing party) all Confidential Information and all copies, documents, and
things thereof furnished to or otherwise in the possession of Consultant and/or
its employees, agents or representatives, except for one archival copy, which
shall remain subject to the terms of this Section 5.

(d) Consultant recognizes that the disclosure of Confidential Information may
give rise to irreparable injury to Company, or to the owner of such Confidential
Information, and that

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

money damages may not provide an adequate remedy. Accordingly, the Company may
seek and obtain injunctive relief against the breach or threatened breach of the
within undertakings, in addition to any legal or equitable remedies which may be
available.

(e) Neither Party will use, or authorize others to use, the name, symbols, or
marks of the other Party in any advertising or publicity material which would
constitute an express or implied endorsement by the other Party of any
commercial product or service without that other Party’s prior written approval.

6. Term and Termination. The term of this Agreement will commence on the later
of the date [*] and the date on which the shareholders of Ovamed have approved
an employment agreement between Consultant and [*] (the “Effective Date”) and
continue for a period expiring on the one year anniversary of the Effective
Date, provided, however, that (a) the Term will be automatically extended for
additional one year periods so long as the [*] remains in effect, unless either
Party provides written notice of termination to the other Party at least thirty
(30) days prior to expiration of the then current Term, (b) the Term will
automatically terminate in the event [*] becomes an employee of the Company
(whereby any such employment of [*] with the Company shall be arranged and
agreed between the Company and [*] so as to provide for a start date being the
1st day of the relevant month in which such employment shall start), and (c) if
either Party defaults in the performance of any obligation or provision of this
Agreement and, assuming such default is capable of cure, fails to cure such
default within thirty (30) days after written notice specifying the default, the
non-defaulting Party giving notice may, at its option, terminate this Agreement
immediately upon written notice to the defaulting Party. Without limiting the
generality of the foregoing, in the event [*] is unable, unwilling or otherwise
unavailable to perform Services on behalf of Consultant substantially in
accordance with the terms and conditions of this Agreement, Company shall have
the right to terminate this Agreement on ten (10) days written notice. Upon the
termination of this Agreement, each Party will be released from all obligations
and liabilities to the other occurring or arising after the effective date of
termination, except that such termination will not relieve either Party of its
obligations under Paragraphs 4, 5, and 7, or from liability arising from any
breach of this Agreement. The Parties also acknowledge and agree that
notwithstanding any termination of this Agreement, Paragraph 2.2 of the Second
Amendment shall remain in full force and effect in accordance with its terms.

7. Covenant not to Compete. During the Term and for a period of one year
thereafter (the “Restricted Period”), [*] shall not engage in competition with
the Company and/or any of its affiliates, either directly or indirectly, in any
manner or capacity, as adviser, principal, agent, affiliate, promoter, partner,
officer, director, employee, stockholder, owner, co-owner, consultant, or member
of any association or otherwise, in any phase of the business of developing,
manufacturing and marketing of products or services that are in the same field
of use and which materially compete with the products or services of the
Company, except with the prior written consent of the Company’s Board of
Directors. Notwithstanding the foregoing, [*] with Ovamed, shall not constitute
a breach of this Paragraph 7.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

8. Inside Information. [*] recognizes that in the course of performing Services
hereunder, [*] may receive from Company or others information that may be
considered “material, nonpublic information” concerning a public company that is
subject to the reporting requirements of the Securities and Exchange Act of
1934, as amended. [*] agrees NOT to:

(a) buy or sell any security, option, bond or warrant of any such public company
(including the Company) while in possession of relevant material, nonpublic
information received from Company or others in connection herewith;

(b) provide Company with information with respect to any public company that may
be considered material, nonpublic information; or

(c) provide any person with material, nonpublic information, received from
Company, including any relative, associate, or other individual who intends to,
or may, (a) trade securities with respect to the company which is the subject of
such information, or (b) otherwise directly or indirectly benefit from such
information.

9. Representations, Warranties and Covenants. Consultant and [*] each separately
(in the sense that wherever in the following the Consultant is mentioned the
respective representation etc. shall only be considered made by the Consultant,
and where [*] is mentioned the respective representation etc. shall only be
considered made by [*], and not by the Consultant) represent, warrant and
covenant to Company that:

(a) Neither Consultant nor [*] is a party to any agreement that would prevent
Consultant or [*] from entering into or performing this Agreement and neither
Consultant nor [*] will enter into any agreement that is in conflict with
Consultant’s obligations under this Agreement;

(b) [*] has the experience, capability, and resources to efficiently and
expeditiously provide the Services under this Agreement, and the Services shall
be performed in a workmanlike manner with professional diligence and skill and
in conformance with applicable specifications or requirements;

(c) Consultant and [*] shall comply with all applicable laws, regulations,
rules, requirements, ordinances and other requirements of local and state
authorities and the United States federal government during the Term of and in
the performance of Services and Consultant’s actions in entering into and
performing this Agreement have been and will be consistent with ethical business
practice; and

(d) None of [*], Consultant, Ovamed, nor any of Consultant’s or Ovamed’s
employees who perform or may perform Services under this Agreement (i) is now or
has in the past been suspended, proposed for debarment or debarred by the United
States Food and Drug Administration or any other government or regulatory
authority; (ii) has ever been convicted of a felony under federal law for
conduct relating to the development or approval of a drug product and/or
relating to a drug product; or (iii) is currently suspended or otherwise
excluded by any governmental entity from receiving federal contracts.

10. Independent Contractor. For purposes of this Agreement and all Services to
be provided hereunder, neither Consultant nor [*] shall be considered a partner,
co-venturer, agent, employee, or representative of Company, but each shall
remain in all respects an independent contractor. Neither Consultant nor [*]
shall have any right or authority to make or undertake

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

any promise, warranty or representation, to execute any contract, or otherwise
to assume any obligation or responsibility in the name of or on behalf of the
Company. As an independent contractor, neither Consultant nor [*] shall
participate in any employee benefits provided by the Company to its employees,
including worker’s compensation insurance, disability, pension or other employee
plans. Consultant assumes full responsibility and liability for the payment of
any taxes due on money received by Consultant hereunder. In making payments to
Consultant under this Agreement, Company will not make any deductions for taxes
unless required by applicable law. As an independent contractor, Consultant
shall provide Company with a Form W-9, or such other form as may be required by
applicable law, at least ten business days prior to any required payments
hereunder.

11. Waiver. The waiver of either Party or the failure by either Party to claim a
breach of any provision of this Agreement shall not be deemed to constitute a
waiver or estoppel with respect to any subsequent breach or with respect to any
provision thereof.

12. Assignment. The rights and liabilities of the Parties will bind and inure to
the benefit of their respective successors, heirs, executors and administrators,
as the case may be, provided that Consultant may not assign or delegate its or
[*] obligations under this Agreement either in whole or in part.

13. Complete Understanding; Modification. Except as expressly provided herein,
this Agreement supersedes and render null and void any and all prior agreements
between the Parties and their agents and personnel on the subject of this
Agreement. Any modifications to this Agreement must be in writing and signed by
the Parties.

14. Notices. Any notices required or permitted hereunder will be given in
writing to the appropriate Party at the address specified above or at such
address as the Party will specify. Such notice will be deemed given upon
personal delivery to the appropriate address or sent by certified or registered
mail, three days after the date of mailing. A copy of any notices given by the
Company to the Consultant shall simultaneously be sent to: Ovamed GmbH,
Kiebitzhörn 31, 22885 Barbuttel, Germany, Attention: General Manager, (CEO), Mr.
Alexander Beese, Fax No.: [*], Email: [*]

15. Miscellaneous. This Agreement may be executed in one or more counterparts by
the Parties by signature of a person having authority to bind the Party, each of
which when executed and delivered, will be an original and all of which will
constitute one and the same Agreement. Signatures to this Agreement transmitted
by fax, by email in “portable document format” (“.pdf”) or by any other
electronic means intended to preserve the original graphic and pictorial
appearance of this Agreement shall have the same effect as physical delivery of
the paper document bearing original signature.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date of
the last signature set forth below:

 

CORONADO BIOSCIENCES, INC.

By:

 

 

Name:

 

 

Title:

 

 

Date:

 

 

TSO LABORATORIES, INC.

 

By:

 

 

Name:

 

Title:

 

Date:

 

 

Agreed and Acknowledged:

 

 

[*]

Date:

 

 

OVAMED GMBH

 

By:

 

 

Name:

 

Title:

 

Date:

 

 

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

Appendix 2.7

Assignment and Assumption of Lease

 

25

--------------------------------------------------------------------------------

Execution Copy

ASSIGNMENT AND ASSUMPTION

OF LEASE

This ASSIGNMENT AND ASSUMPTION OF LEASE (this “Assignment”) is made this 21st
day of December, 2012, by TSO LABORATORIES, INC., a Massachusetts corporation,
with an address of 355 Providence Highway, Suite 200, Westwood, MA 02030 (the
“Assignor”), to and for the benefit of CORONADO BIOSCIENCES, INC., a Delaware
corporation, with an address of 24 New England Executive Park, Suite 105,
Burlington, MA 01803 (the “Assignee”).

WHEREAS, Assignor is the Lessor under that certain Standard Form Commercial
Lease dated as of December 21, 2012, including the Rider to Lease, by and
between Assignor and Cummings Properties, LLC (the “Lease”), pursuant to which
Assignor leased approximately 8,726 square feet located at 233 and 230 West
Cummings Park, Woburn, Massachusetts (the “Premises”);

WHEREAS, Assignor desires to assign the Lease to Assignee and Assignee desires
to assume the Lease.

NOW, THEREFORE, in consideration of the mutual covenants and conditions set
forth below and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, Assignor and Assignee agree as
follows:

1. Assignment. Assignor hereby assigns, sells, grants, conveys, transfers and
delivers to Assignee all of Assignor’s right, title and interest in, to and
under the Lease.

2. Acceptance, Assumption. Assignee accepts such assignment and assumes all
obligations of the Tenant (including payment obligations) under the Lease. In
particular, Assignee shall timely pay the security deposit provided for in the
Lease and the first installment as well as all further installments of the
Construction Charge (as defined in Lease) to Cummings Properties, LLC.

3. Notices. All notices and other communications required or permitted hereunder
shall be in writing and sent to the recipient party at the address set forth for
such party in the preamble hereto, or to such other address which either party
hereunder may designate by notice to the other given as required hereby. Any
such notice or communication shall be given either (a) by registered or
certified mail, postage prepaid and return receipt requested, (b) by overnight
delivery using a nationally recognized overnight courier which provides a
receipt to sender, (c) by facsimile or (d) by electronic mail. Such notices
shall be deemed given when received or refused by the recipient. A copy of any
notices given by the Assignee to the Assignor shall simultaneously be sent to:
Ovamed GmbH, Kiebitzhörn 31, 22885 Barsbuttel, Germany, Attention: General
Manager, (CEO), Mr. Alexander Beese, Fax No.: [*], Email: [*]

4. Headings. The title of articles and the headings preceding text of paragraphs
and sub-paragraphs herein are for convenience of reference only and shall not
constitute a part of this Assignment, nor shall they affect its meaning or
construction.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

--------------------------------------------------------------------------------

5. Invalidity of Provision. If any provision, term or condition of this
Assignment or the application thereof to any persons or circumstances should be
declared invalid by the final ruling of a court of competent jurisdiction, the
remaining provisions, terms and conditions hereof and their application to
persons and circumstances shall not be affected thereby and shall continue to be
enforced and recognized as valid agreements of the parties, and in the place of
such invalid or unenforceable provision, there shall be substituted a like but
valid provision which comports to the findings of such court and most nearly
accomplishes the original intention of the parties.

6. Waiver. The waiver by either party to this Assignment of the other’s breach
of any provision, term or condition hereof shall not be held or construed
(unless expressly so declared in writing) to impair the continuing obligation of
such provision, term or condition, nor, except as to the specific instance, to
permit similar acts or omissions by the other. The failure of either party to
enforce against the other, or to insist on strict performance by the other of,
any provision, term or condition hereof shall not be deemed a waiver of the
latter’s default with respect thereto, nor a waiver of the former’s right to
enforce the same or any other provision, term or condition hereof in the future.

7. Counterparts. This Assignment may be executed in counterparts, each of which
shall be deemed an original, and all of which together shall constitute one and
the same instrument.

8. Governing Law. This Assignment shall be governed by the laws of The
Commonwealth of Massachusetts.

9. Submission to Jurisdiction. To the fullest extent it may do so under
applicable law, each party to this Assignment knowingly, intentionally and
voluntarily, with and upon the advice of competent counsel (a) submits to
personal jurisdiction in The Commonwealth of Massachusetts with respect to any
action, suit or proceeding based upon, arising out of or in any way relating
hereto, (b) agrees that such action, suit or proceeding may be brought in any
state or federal court of competent jurisdiction in said state, (c) submits to
the jurisdiction of such courts, and (d) agrees that it will not bring any
action, suit or proceeding against the other party with respect hereto in any
other forum.

10. Successors and Assigns. This Assignment shall be binding upon and inure to
the benefit of the parties hereto and their respective heirs, executors,
administrators, successors and assigns.

11. Entire Agreement. This Assignment constitutes the entire agreement between
the parties hereto with respect to the matters described herein and supersedes
any prior or contemporaneous agreements, understandings, inducements and
conditions, express or implied, oral or written, in such regard. No verbal
statements made by anyone with respect to such matters shall be construed as a
part hereof unless incorporated herein by writing. This Assignment may be
amended, modified or supplemented only by an instrument in writing executed and
delivered by both parties hereto.

[SIGNATURE PAGE FOLLOWS.]

 

- 2 -

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the parties hereto have executed and delivered this
Assignment as of the date set forth in the preamble hereof.

 

Assignor: TSO LABORATORIES, INC. By:  

 

Name:  

 

Title:  

 

Assignee: CORONADO BIOSCIENCES, INC. By:  

 

Name:  

 

Title:  

 

 

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