Exhibit 10.1

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) dated as of August 4, 2014 (the
“Effective Date”) is between NERVIANO MEDICAL SCIENCES S.r.l., an Italian
corporation (“Nerviano”), having a place of business at viale Pasteur, 10, 20014
Nerviano, Italy, and IGNYTA, INC., a Delaware corporation (“Ignyta”), having a
place of business at 11095 Flintkote Avenue, Suite D, San Diego, CA 92121,
U.S.A. A “Party” shall mean either of Nerviano and Ignyta and “Parties” shall
mean both Nerviano and Ignyta.

WHEREAS, Nerviano is developing compounds for the treatment of oncology diseases
and owns or has rights in the APIs and Licensed IP Rights (as each is defined
below).

WHEREAS, Ignyta has capabilities in the development of oncology products and
desires to obtain an exclusive license under Nerviano’s rights in the APIs and
Licensed IP Rights on the terms and conditions set forth below.

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

 

1. DEFINITIONS

For purposes of this Agreement, the terms defined in this Section 1 shall have
the respective meanings set forth below:

1.1 “Acquiror” shall mean a Pharmaceutical Company that after the Execution Date
acquires control of Ignyta as a result, and upon consummation, of a Change of
Control, where “Pharmaceutical Company” means any entity that, directly or
through one or more of its Affiliates, is involved in the business of
researching, testing, developing, manufacturing, packaging, marketing,
distributing or selling medical devices, medical diagnostic products, or
pharmaceutical or medicinal products, formulations or compounds.

1.2 “Affiliate” shall mean, with respect to a Party, a person, corporation,
partnership, or other entity that controls, is controlled by or is under common
control with such Party, provided that, with respect to Nerviano, Affiliate
means a person, corporation, partnership, or other entity that is controlled by
Nerviano and/or NMS Group S.r.l., or is under common control with Nerviano. For
the purposes of this definition, (i) an Affiliate is considered an Affiliate
regardless of whether such Affiliate is an Affiliate on the Effective Date or
becomes an Affiliate after the Effective Date and (ii) the word “control”
(including, with correlative meaning, the terms “controlled by” or “under the
common control with”) means the actual power, either directly or indirectly
through one (1) or more intermediaries, to direct or cause the direction of the
management and policies of such entity either by the ownership of at least fifty
percent (50%) of the voting stock of such entity or the ability to otherwise
control the management of the corporation.

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1.3 “API” shall mean one or more of the following small molecules that binds to
and inhibits the applicable Exclusive Target and that are specifically disclosed
and generically described in (a) Nerviano Patent Cases NMS 015, 042 and 071 such
as the molecule known internally at Nerviano as Nerviano-01104862 with the
chemical structure set forth on Exhibit 1.3, together with its pharmaceutically
acceptable salts, esters, ethers, hydrates, isomers, analogs, metabolites,
mixtures of isomers, complexes or derivatives (any of such molecules, the “CDC7
API” and collectively, the “CDC7 APIs”), and (b) the small molecules described
in Nerviano Patent Case NMS 093 such as the molecules known internally at
Nerviano as Nerviano-P616 or Nerviano-P753, with the chemical structures set
forth on Exhibit 1.3, as well as any and all back-up compounds that are part of
Nerviano’s RET project lead optimization process, together with any
pharmaceutically acceptable salts, esters, ethers, hydrates, isomers, analogs,
metabolites, mixtures of isomers, complexes or derivatives of any of the
foregoing (any of such molecules, the “RET API” and collectively, the “RET
APIs”).

1.4 “Change of Control” shall mean the occurrence of any of the following after
the Effective Date:

(a) a transaction or series of related transactions that results in the sale,
transfer or other disposition of all or substantially all of Ignyta’s assets;

(b) a merger or consolidation in which Ignyta is not the surviving corporation
or in which, if Ignyta is the surviving corporation, the beneficial owners of
the outstanding voting securities of Ignyta immediately prior to the
consummation of such merger or consolidation do not, immediately after
consummation of such merger or consolidation, beneficially own, directly or
indirectly, stock or other securities of Ignyta that possess 50% or more of the
voting power of all Ignyta’s outstanding stock and other securities;

(c) a transaction or series of related transactions (which may include, without
limitation, a tender offer for Ignyta’s stock or the issuance, sale or exchange
of stock of Ignyta) whereby the beneficial owners of the outstanding voting
securities of Ignyta immediately prior to such transaction or series of
transactions do not, immediately after consummation of such transaction or any
of such related transactions, own stock or other securities of Ignyta that
possess 50% or more of the voting power of all Ignyta’s outstanding stock and
other securities; or

(d) the acquisition (whether in a single transaction or series of related
transactions) after the Effective Date by a Third Party or Group (as such term
is defined in the Securities Exchange Act of 1934, as amended) of beneficial
ownership of 50% or more of Ignyta’s voting securities or other securities,
indebtedness or other rights convertible into such voting securities; provided,
that a Change of Control shall not include any transaction or series of
transactions solely for bona fide financing purposes in which cash is received
by Ignyta or indebtedness of Ignyta is cancelled or converted or a combination
thereof for so long as the Third Party or Group acquiring such ownership does
not then or thereafter have any other relationship with Ignyta other than such
financing or investing arrangement, including any arrangement involving the
development, manufacture or commercialization of a Product.

1.5 “Commercially Reasonable Efforts” means, as applied to Ignyta, its Affiliate
or a Sublicensee, those efforts and resources that a company within the
bio-pharmaceutical industry

 

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at a similar stage of development as Ignyta, such Affiliate or such Sublicensee,
as applicable, would use for a compound or product with similar market and/or
commercialization prospects at a similar stage in its product life cycle, taking
into account the stage of development or commercialization of the compound or
product, the cost-effectiveness of efforts or resources while optimizing
profitability, the competitiveness of alternative compounds or products that are
or are expected to be in the marketplace, the patent and other proprietary
position of the compound or product, the profitability of the compound or
product and alternative compounds or products and other relevant commercial
factors. For purposes of this Section 1.5, milestone and royalty payments
required to be paid to Nerviano under this Agreement shall not be considered in
evaluating profitability or other economic factors.

1.6 “Competent Authority(ies)” shall mean, collectively, (a) the governmental
entities in each country or supranational organization that is responsible for
the regulation of any Product or the establishment, maintenance and/or
protection of rights related to the Licensed IP Rights (including the FDA, the
EMA and the MHLW), or (b) any other applicable regulatory or administrative
agency in any country or supranational organization that is comparable to, or a
counterpart of, the foregoing.

1.7 “Competing Product” means any small molecule that has a binding affinity for
one or more of the Exclusive Targets and was specifically developed, directed or
clinically tested against an Exclusive Target, and that is not an API.

1.8 “Confidential Information” means all embodiments of Nerviano Licensed IP
Rights and all other information disclosed, directly or indirectly, by one Party
to the other during the term of this Agreement or prior to the Effective Date,
that is identified as confidential or is customarily regarded as confidential
within the pharmaceutical industry, whether disclosed in electronic, tangible,
oral or visual form. Without limiting the generality of the foregoing, Ignyta’s
Confidential Information includes the Royalty Reports made by Ignyta to Nerviano
under Article 5 of this Agreement. Confidential Information shall not include
such information that: (a) was or becomes generally available to the public
other than as a result of an unauthorized disclosure by a Party hereto or any of
such Party’s Affiliates, employees, agents or representatives; (b) was or
becomes available to a Party hereto on a non-confidential basis from a source
other than (in the case of future information) any other Party hereto (or any of
such Party’s Affiliates, employees, agents or representatives); provided that
such source was not known to be bound by any agreement to keep such information
confidential or otherwise prohibited from transmitting the information by a
contractual, legal or fiduciary obligation; or (c) is independently developed by
any Party hereto without the use of or reference to the Confidential Information
of the other Party hereto or any of such other Party’s Affiliates. Information
that is otherwise Confidential Information and consists of a combination of
information shall not be deemed to be in the public domain if individual
elements of such information are in the public domain, unless the specific
combination of those elements is also in the public domain.

1.9 “Control” or “Controlled” with respect to intangible or intellectual
property rights (including patent rights, know-how, trade secrets and rights to
access or cross-reference regulatory filings) means possession of the right to
grant a license or sublicense hereunder without violating the terms of any
agreement or other arrangement with any Third Party existing

 

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at the time the applicable Party would be first required hereunder to grant the
other Party such license or sublicense.

1.10 “Development” means all studies and other activities required to be
conducted prior to NDA Approval, including non-clinical testing, clinical
studies, packaging and regulatory affairs, and any clinical or other studies
required to be conducted after NDA Approval as a condition to approval of an
NDA.

1.11 “Development Data” means all non-clinical and clinical data (including raw
data, analyses and reports), including pharmacological, pharmaceutical,
pharmacokinetic and toxicological data, relating to an API or a Product that is
Controlled at any time during the term of this Agreement by either Party or
their Affiliates, including all such data generated by a CRO for a Party.

1.12 “Early Development Term” means the term starting from the Effective Date
and ending with the dosing of the first patient in the first Phase I Clinical
Trial during the term of this Agreement or with the second anniversary of the
Effective Date, whichever occurs first.

1.13 “EMA” shall mean the European Agency for the Evaluation of Medicinal
Products of the European Union, or the successor thereto.

 

1.14 “Exclusive Targets” shall mean the following:

(a) the protein commonly known as CDC7, with [***],

(b) the protein commonly known as RET, with [***], and

(c) any derivatives, parts or polymorphisms (including without limitation splice
variants) of any of the foregoing proteins and the nucleotide sequences that
encode any of the foregoing.

 

1.15 “FDA” shall mean the Food and Drug Administration of the United States, or
the successor thereto.

1.16 “Field” shall mean all fields of use, including without limitation the
diagnosis, prevention or treatment of any disease, state or condition in humans
or other animals.

1.17 “First Commercial Sale” shall mean, with respect to any Product, the first
sale of such Product to an end user after all necessary marketing and pricing
approvals (if any) have been granted by the applicable governing health
authority of such country.

1.18 “Ignyta Know-How” means know-how that (a) is Controlled by Ignyta or its
Affiliates as of the Effective Date or during the term of the Agreement and
(b) is necessary or useful to develop, make, have made, use, sell, offer to
sell, import, export, register and promote a Product

 

 

***

Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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in the Territory, but only to the extent that such know-how is related to an API
or a Product or a method of using or manufacturing an API or Product.

1.19 “Ignyta Patents” means the patents and patent applications (including
provisional applications, continuations, divisionals and continuations-in-part)
that are Controlled by Ignyta or its Affiliates as of the Effective Date or at
any time during the term of this Agreement that, in each case, claim an API, a
Product or their method of formulation, manufacture or use, and all patents
issuing therefrom (and all substitutions, reissues, renewals, reexaminations,
supplementary protection certificates, extensions, registrations and
confirmations of any of the foregoing patents).

1.20 “Inventions” shall mean any invention, improvement, modification, know-how,
information or other technology that is first conceived by either or both of the
Parties pursuant to work conducted in the Development of Products.

 

1.21 “Licensed IP Rights” shall mean, collectively, the Nerviano Patents and the
Nerviano Know-How.

1.22 “Major Market Countries” shall mean the United States, United Kingdom,
France, Spain, Italy, Germany, Japan and China.

 

1.23 “MHLW” shall mean the Ministry of Health, Labour and Welfare of Japan, or
the successor thereto.

1.24 “NDA” shall mean a New Drug Application, or similar application for
marketing approval of a Product submitted to the FDA, EMA or MHLW, or any
comparable Competent Authority.

 

1.25 “NDA Approval” shall mean the approval of an NDA by all applicable
Competent Authorities.

1.26 “Nerviano Know-How” shall mean all trade secrets and other know-how rights
in and to all data, information, regulatory correspondence, compositions and
other technology (including, but not limited to, formulae, procedures,
protocols, techniques and results of experimentation and testing) that are
(a) Controlled by Nerviano or its Affiliates as of the Effective Date or at any
time during the term of this Agreement and (b) are necessary or useful for
Ignyta to make, use, develop, sell or seek regulatory approval to market a
composition, or to practice any method or process, at any time claimed or
disclosed in any issued patent or pending patent application within the Licensed
IP Rights or that otherwise relate to the APIs, the Products or their
manufacture or use.

1.27 “Nerviano Patents” shall mean the patents that are Controlled by Nerviano
or its Affiliates as of the Effective Date or at any time during the term of
this Agreement and are (a) the patents and patent applications listed on
Exhibit 1.27, (b) all patents and patent applications in any country of the
world that claim or cover any or all of the APIs, the Products or the
manufacture or use thereof, and in which Nerviano heretofore or hereafter has an
ownership or (sub)licensable interest, (c) all divisions, continuations,
continuations-in-part, that claim priority to, or common priority with, the
patent applications described in clauses (a) and

 

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(b) above or the patent applications that resulted in the patents described in
clauses (a) and (b) above, and (d) all patents that have issued or in the future
issue from any of the foregoing patent applications, including utility, model
and design patents and certificates of invention, together with any reissues,
renewals, extensions or additions thereto.

1.28 “Net Sales” means the gross amount invoiced on sales of a Product by
Ignyta, or its Affiliates or Sublicensees, to unrelated Third Parties less
deductions for the following items, as allocable to such Product (if not
previously deducted from the amount invoiced), consistent with customary
business practices and in accordance with U. S. Generally Accepted Accounting
Principles, consistently applied:

(a) any rebates, quantity, trade and cash discounts;

(b) charge-back payments and rebates granted to managed health care
organizations or to federal, state, and local governments, their respective
agencies, purchasers, or reimbursers, including mandatory rebates;

(c) retroactive price reductions, credits or allowances actually granted upon
rejections or returns, including for recalls or damaged goods;

(d) a reasonable allowance for bad debts;

(e) freight, insurance, data and other charges or fees related to shipping or
handling or services provided in connection with such shipping or handling (to
the extent borne by the Party) and inventory management fees, discounts or
credits provided that the cumulative annual amount of such deduction under this
paragraph (e) shall not exceed three percent (3%) of the cumulative annual gross
sales; and

(f) sales taxes, excise taxes, use taxes, tariffs and import/export duties, or
other governmental charges actually due or incurred with respect to such sales,
including value-added taxes.

All such discounts, allowances, credits, rebates and other deductions shall be
fairly and equitably allocated to the Product and other products or services of
Ignyta, and its Affiliates or Sublicensees, such that the Product does not bear
a disproportionate portion of such deductions. The transfer of Product by Ignyta
to an Affiliate or Sublicensee of Ignyta shall not be considered a sale. Every
other commercial use or disposition of a Product by Ignyta or its Sublicensees
in barter or other transactions (other than dispensing of reasonable and
customary quantities for promotional sampling, for testing or trials, or for
compassionate use) shall be considered a sale of such Product at the weighted
average Net Sales price for such Product during the preceding quarter.

Where the consideration for Products includes any non-cash element, the Net
Sales applicable to any such transaction shall be the fair market value for the
applicable quantity for the period in question in the applicable country of the
Territory. The fair market value shall be determined, wherever possible, by
reference to the average selling price of the relevant Product in arm’s length
transactions in the relevant country.

 

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If a Product is sold in a package or formulated in combination with one or more
other active ingredients that are not an API (as used in this definition of Net
Sales, a “Combination Product”), then for each quarter payment period and on a
country-by-country basis, the gross amount invoiced for that Product shall be
calculated by multiplying the gross amount invoiced for such Combination Product
by the fraction A/(A+B), where “A” is the gross amount invoiced for the Product
sold separately and “B” is the gross amount invoiced for the other active
ingredient(s) sold separately. If the other active ingredient is not sold
separately, then the gross amount invoiced for that Product shall be calculated
by multiplying the gross amount invoiced for the Combination Product by the
fraction A/C, where “A” is the gross invoice amount for the Product, if sold
separately, and “C” is the gross invoice amount for the Combination Product. If
a particular Combination Product is not addressed by the foregoing, Net Sales
for royalty determination shall be determined by the Parties in good faith.

1.29 “Non-Royalty Income” means any and all consideration in any form provided
by a Sublicensee to Ignyta or any of its Affiliates for a grant of a sublicense
under any of the Licensed IP Rights including without limitation [***].

1.30 “Person” shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.

1.31 “Phase I Clinical Trial” shall mean a human clinical trial that is intended
to initially evaluate the safety and/or pharmacological effect of a Product in
subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or
its foreign equivalent.

1.32 “Phase II Clinical Trial” shall mean a human clinical trial in any country
that is intended to initially evaluate the effectiveness of a Product for a
particular indication or indications in patients with the disease or indication
under study or would otherwise satisfy requirements of 21 CFR 312.21(b), or its
foreign equivalent. A Phase IIa Clinical Trial shall not be a Phase II Clinical
Trial until such time as the portion of the clinical trial described above is
commenced. For the avoidance of doubt, a phase I/II expansion cohort study shall
not be a Phase II Clinical Trial.

1.33 “Phase IIa Clinical Trial” shall mean a human clinical trial in any country
that is solely intended to make a preliminary determination of the effectiveness
of a Product for a particular indication or indications in patients with the
disease or indication under study.

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

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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1.35 “Product(s)” shall mean any product that incorporates any or all of the
APIs and if made, used, sold, offered for sale or imported absent the license
granted hereunder would infringe a Valid Claim, or that otherwise uses or
incorporates the Nerviano Know-How.

1.36 “Registration(s)” shall mean any and all permits, licenses, authorizations,
registrations or regulatory approvals (including NDAs) required and/or granted
by any Competent Authority as a prerequisite to the development, manufacturing,
packaging, marketing and selling of any product.

1.37 “Royalty Term” shall mean, with respect to each Product in each country,
the longer of (a) the period during which a Valid Claim remains in effect and
would be infringed but for the license granted by this Agreement, by the use,
offer for sale, sale or import of such Product in such country, and (b) ten
(10) years after the First Commercial Sale of such Product in such country.

1.38 “Sublicense Agreement” means any agreement or set of agreements under which
Ignyta grants a Sublicensee a sublicense, option or other right allowing such
Sublicensee to develop, use, distribute or sell a Product. A distributor
agreement shall not be a Sublicense Agreement.

1.39 “Sublicensee” means an Affiliate or Third Party to whom Ignyta grants a
sublicense under any Licensed IP Rights to develop, use, distribute or sell a
Product in the Territory, or otherwise grants any right to develop, promote,
distribute and sell a Product in the Territory. A distributor shall not be a
Sublicensee.

 

1.40 “Territory” shall mean the world.

 

1.41 “Third Party” shall mean any Person other than Nerviano, Ignyta and their
respective Affiliates.

1.42 “Valid Claim” shall mean a claim of an issued and unexpired patent included
within the Licensed IP Rights, which has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise.

 

1.43 “Interpretation.”

(a) Whenever any provision of this Agreement uses the term “including” (or
“includes”), such term shall be deemed to mean “including without limitation”
and “including but not limited to” (or “includes without limitations” and
“includes but is not limited to”) regardless of whether the words “without
limitation” or “but not limited to” actually follow the term “including” (or
“includes”);

(b) “Herein,” “hereby,” “hereunder,” “hereof” and other equivalent words shall
refer to this Agreement as an entirety and not solely to the particular portion
of this Agreement in which any such word is used;

 

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(c) The recitals set forth at the start of this Agreement, along with the
Exhibits and Schedules to this Agreement, and the terms and conditions
incorporated in such recitals, Exhibits and Schedules shall be deemed integral
parts of this Agreement and all references in this Agreement to this Agreement
shall encompass such recitals, Exhibits and Schedules and the terms and
conditions incorporated in such recitals, Exhibits and Schedules;

(d) Unless otherwise provided, all references to Sections, Articles, Schedules
and Exhibits in this Agreement are to Sections, Articles, Schedules and Exhibits
of and to this Agreement;

(e) All references to days, months, quarters or years are references to calendar
days, calendar months, calendar quarters or calendar years;

Any reference to any federal, national, state, local or foreign statute or law
shall be deemed to also refer to all rules and regulations promulgated
thereunder, unless the context requires otherwise.

 

2. REPRESENTATIONS AND WARRANTIES

2.1 Mutual Representations and Warranties. Each Party hereby represents and
warrants to the other Party as of the Effective Date as follows:

(a) Such Party is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is incorporated.

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

(c) All necessary consents, approvals and authorizations of all governmental
authorities and other Persons required to be obtained by such Party in
connection with this Agreement have been obtained.

(d) The execution and delivery of this Agreement and the performance of such
Party’s obligations hereunder (a) do not conflict with or violate any
requirement of applicable laws or regulations, and (b) do not conflict with, or
constitute a default under, any contractual obligation of it.

2.2 Additional Nerviano Representations and Warranties. Nerviano hereby
represents and warrants to Ignyta that Nerviano (a) is the sole owner or
exclusive licensee of the Licensed IP Rights, and except as Nerviano has
expressly informed Ignyta in writing prior to the date of this Agreement, has
not granted to any Third Party any license or other interest in the Licensed IP
Rights, (b) is not aware of any Third Party patent, patent application or other
intellectual property rights that would be infringed (i) by practicing any
process or method or by making, using or selling any composition which is
claimed or disclosed in the Nerviano Patents or which constitutes Nerviano
Know-How or (ii) by making, using or selling Products, (c) is not aware of

 

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any infringement or misappropriation by a Third Party of the Licensed IP Rights,
(d) all inventors of the inventions claimed in the Nerviano Patents have
assigned all their right, title and interest in and to such inventions to
Nerviano, and (e) is not, either directly or indirectly through any Affiliate,
(i) developing and/or commercializing a Competing Product, or (ii) enabling or
licensing any Third Party to research, develop and/or commercialize a Competing
Product.

2.3 Additional Ignyta Representations and Warranties. Ignyta hereby further
represents and warrants to Nerviano that as, of the Effective Date, to its
knowledge no Pharmaceutical Company owns more than five (5) percent of Ignyta’s
currently outstanding and fully diluted shares of stock or other securities of
Ignyta, indebtedness or options, warrants or other rights convertible into such
securities, nor has entered into any agreement or other arrangement to acquire
any such securities or other rights.

2.4 Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT OR MANDATED BY APPLICABLE LAW (WITHOUT THE RIGHT TO WAIVE OR
DISCLAIM), NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY WITH RESPECT TO
THE PRODUCT, ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS, THE SUCCESS OF EFFORTS
CONTEMPLATED UNDER THIS AGREEMENT, OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND
HEREBY DISCLAIMS ALL WARRANTIES, CONDITIONS OR REPRESENTATIONS OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF PERFORMANCE,
MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

 

3. LICENSE GRANT; EXCLUSIVITY

3.1 Licensed IP Rights.

(a) Nerviano hereby grants to Ignyta an exclusive license (with the right to
grant Sublicenses subject to Section 3.3) under the Licensed IP Rights to
conduct research and to develop, make, have made, use, offer for sale, sell and
import Products in the Territory for use in the Field.

(b) Nerviano hereby grants to Ignyta a royalty-free, non-exclusive license (with
the right to grant Sublicenses subject to Section 3.3) under any patent,
know-how or other intellectual property rights Controlled by Nerviano to
research and to develop, make, have made, use, offer for sale, sell and import
any diagnostic product for one or more of the Exclusive Targets.

3.2 Exclusivity. For the period commencing with the Effective Date and ending
[***], neither Nerviano nor its Affiliates shall, directly or indirectly,
initiate or conduct (or enable or

 

 

***

Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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license any Third Party to) research, develop and/or commercialize a Competing
Product; provided that [***].

3.3 Sublicenses. Subject to the terms and consistent with the obligations of
this Agreement, Ignyta shall have the right to grant sublicenses within the
scope of the licenses under Section 3.1. For the avoidance of doubt, the right
for Ignyta to grant sublicenses is intended to include the right to further
sublicense provided that Ignyta or its Sublicensee shall inform Nerviano in
writing of such further sublicense.

3.4 Availability of the Licensed IP Rights and APIs; Relevant Information.

(a) Nerviano shall promptly provide Ignyta with a copy of all information
available to Nerviano relating to the Licensed IP Rights or APIs, including
without limitation: (a) all quantities of the APIs (whether GMP or non-GMP),
(b) all assays to one or more of the Exclusive Targets (including diagnostic,
pharmacology or release assays), (c) information and know-how regarding the
manufacture or use of the APIs or otherwise relating to the Exclusive Targets,
(d) regulatory submissions, (e) communications with the Competent Authorities
(including the minutes of any meetings), (f) trial master files, including case
report forms, (g) listings and tables of results from non-clinical studies,
(h) storage of and access permission to any retained samples of materials used
in non-clinical studies, and (j) access to CROs, sites and investigators
involved in non-clinical studies.

(b) Upon the request of Ignyta, Nerviano will promptly provide Ignyta with a
copy of all information existing at the Effective Date available to Nerviano
relating to the Predecessor Compound, including without limitation: (a) all
information and know-how regarding the manufacture or use of the Predecessor
Compound, (b) regulatory submissions, (c) communications with the Competent
Authorities (including the minutes of any meetings), (d) trial master files,
including case report forms, (e) listings and tables of results from
non-clinical and clinical studies, (f) treatment-related serious adverse event
reports from the clinical trials, (g) storage of and access permission to any
retained samples of materials used in non-clinical studies and clinical trials,
and (h) access to CROs, sites and investigators involved in non-clinical studies
and clinical trials (collectively, “Predecessor Compound Information”). Ignyta
shall have a non-exclusive, worldwide, royalty-free, perpetual right and license
under any applicable intellectual property rights Controlled by Nerviano to use
the Predecessor Compound Information for any purpose related to the diagnosis,
prevention or treatment of any disease, state or condition in humans. For the
avoidance of doubt, subject to Section 3.2, [***].

3.5 Registrations. Nerviano acknowledges and agrees that Ignyta shall own all
Registrations for Products for use in the Field in each country in the
Territory. After the Effective Date, Nerviano shall transfer to Ignyta all
Registrations for Products. Nerviano hereby grants to Ignyta a free-of-charge
right to reference and use and have full access to all other Registrations and
all other regulatory documents that relate to the Licensed IP Rights or APIs,
including INDs, BLAs, NDAs and DMFs (whether as an independent document or as
part of any NDA, and all

 

 

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chemistry, manufacturing and controls information), and any supplements,
amendments or updates to the foregoing (for the purposes of this Section, the
“Right of Reference”). Ignyta shall have the right to (sub)license the Right of
Reference to its Sublicensees and Affiliates. Nerviano shall promptly notify
Ignyta of any written or oral notices received from, or inspections by any
Competent Authority relating to any such Registrations, and shall promptly
inform Ignyta of any responses to such written notices or inspections and the
resolution of any issue raised by such Competent Authority. During the time that
Nerviano is the holder of a Registration, Ignyta shall be entitled to attend any
and all meetings and participate in telephone calls with the Competent
Authorities, including without limitation any meeting preparation, meeting
co-ordination and preparation of minutes.

3.6 Notwithstanding anything to the contrary contained herein, with respect to
the RET APIs, Nerviano will continue development activities (using commercially
reasonable and diligent efforts and resources, but in no event lesser efforts
and resources than have been used by Nerviano to date in such development
activities) through the earlier of (a) December 31, 2014 or (b) the
identification of a RET API that is ready to be moved into toxicology studies in
compliance with current good laboratory practices to support later clinical
development, at which point Ignyta will assume development responsibility,
utilizing Nerviano or its Affiliates in its sole discretion for services in
furtherance of preclinical activities.

 

4. FINANCIAL CONSIDERATIONS

4.1 License Fees.

(a) Subject to the terms of this Agreement, within ten (10) days after the
Effective Date, Ignyta shall pay to Nerviano a non-refundable initial fee of
Three Million Five Hundred Thousand United States Dollars (US $ 3,500,000).

(b) In case of Sublicensing of rights to or under any of the Licensed IP Rights
during the Early Development Term, then Ignyta, in addition to the initial
license fee as per Section 4.1(a), shall pay to Nerviano a further amount equal
to [***] of any Non-Royalty Income received from the Sublicensee.

4.2 Royalties.

Ignyta shall pay Nerviano the following royalties:

4.2.1 During the applicable Royalty Term for a Product, on a Product-by-Product
and country by country basis, subject to the terms and conditions of this
Agreement, with respect to annual Net Sales of each Product by Ignyta its
Affiliates or Sublicensees, Ignyta shall pay to Nerviano royalties (the
“Royalties”) equal to:

(a) for annual Net Sales of such Product in countries where the sale of such
Product is covered by a Valid Claim in such country, then:

 

 

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(i) [***] of the first [***] of such Net Sales,

(ii) [***] of such Net Sales in excess of [***] but less than [***], and

(iii) [***] of such Net Sales in excess of [***]; and

(b) for annual Net Sales of such Product in countries where the sale of such
Product is not covered by a Valid Claim in such country, [***] of such Net
Sales.

Only one Royalty shall be owing for a Product regardless of how many Valid
Claims cover such Product.

4.2.2 Third Party Royalties. If Ignyta, its Affiliates or Sublicensees is
required to pay royalties to any Third Party in order to exercise its rights
hereunder to make, have made, use, sell, offer to sale or import any Product,
then Ignyta shall have the right to credit [***] of such Third Party royalty
payments against the Royalties owing to Nerviano under Section 4.2.1 with
respect to sales of such Product in such country; provided, however, that Ignyta
shall not reduce the amount of the Royalties paid to Nerviano under
Section 4.2.1 by reason of this Section 4.2.2, with respect to sales of such
Product in such country, to less than [***] of the Royalties that would
otherwise be due under Section 4.2.1.

4.3 Milestone Payments.

(a) CDC7 Products. Ignyta shall pay to Nerviano the following amounts within
[***] following the first achievement of the applicable development milestone
event as set forth below with respect to a Product that incorporates a CDC7 API
(a “CDC7 Product”). Each milestone payment is due only one time.

 

Milestone Event

   Payment      (in US Dollars)

[***]

   [***]

(b) RET Products. Ignyta shall pay to Nerviano the following amounts within
[***] following the first achievement of the applicable development milestone
event as set forth below with respect to a Product that incorporates a RET API
(a “RET Product”). Each milestone payment is due only one time.

 

Milestone Event

   Payment      (in US Dollars)

[***]

   [***]

 

 

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(c) For purposes of the above Milestone Events, [***].

(d) In the event any Product that achieves any Milestone Event hereunder
includes both a CDC7 API and a RET API, only the Milestone Payments set forth in
Section 4.3(a) (and not any of the Milestone Payments set forth in
Section 4.3(b)) will apply to such Product that achieves that Milestone Event,
provided that this Section 4.3(d) does not prejudice the payment of Milestones
due under 4.3(b) when achieved for RET Products as single agent or in different
Combination Products.

 

5. ROYALTY REPORTS AND ACCOUNTING

5.1 Royalty Reports. Within sixty (60) days after the end of each calendar
quarter during the term of this Agreement following the First Commercial Sale of
a Product, Ignyta shall furnish to Nerviano a quarterly written report (each, a
“Payment Report”) stating in reasonably specific detail (a) the gross sales of a
Product sold by Ignyta, its Affiliates or Sublicensees, (b) the units sold by
Ignyta, its Affiliates and Sublicensees and the calculation of Net Sales during
such calendar quarter on a country by country basis; (c) the calculation of the
Royalties, if any, that shall have accrued based upon such Net Sales; (d) the
withholding taxes, if any, required by law to be deducted with respect to such
sales; and (e) the exchange rates, if any, used in determining the amount of
United States Dollars. With respect to sales of Products invoiced in United
States Dollars, the gross sales, Net Sales and Royalties payable shall be
expressed in United States Dollars. With respect to Net Sales invoiced in a
currency other than United States Dollars, such amounts shall be expressed both
in the currency in which the distribution is invoiced and in the United States
Dollar equivalent. The United States Dollar equivalent shall be calculated using
the average of the exchange rate (local currency per US$1) published in The Wall
Street Journal, Western Edition, under the heading “Currency Trading” on the
last business day of each month during the applicable calendar quarter.

5.2 Audits.

5.2.1 Ignyta shall keep full and true books of accounts and other records in
sufficient detail so that the Royalties payable hereunder can be properly
ascertained. Upon the written request of Nerviano and not more than once in each
calendar year, Ignyta shall permit an independent certified public accounting
firm of nationally recognized standing selected by Nerviano and reasonably
acceptable to Ignyta, at Nerviano’s expense, to have access during normal
business hours to such books and financial records of Ignyta as may be necessary
to determine the correctness of any Payment Report or payment made under this
Agreement or to obtain information as to Royalties payable in case of failure to
report or pay pursuant to the terms of this Agreement and as may be reasonably
necessary to verify the accuracy of the Payment

 

 

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Reports hereunder for the eight (8) calendar quarters immediately prior to the
date of such request (other than records for which Nerviano has already
conducted an audit under this Section).

5.2.2 If such accounting firm concludes that additional amounts were owed during
the audited period, Ignyta shall pay such additional amounts within thirty (30)
days after the date Nerviano delivers to Ignyta such accounting firm’s written
report so concluding. The fees charged by such accounting firm shall be paid by
Nerviano; provided, however, if the audit discloses that the Royalties payable
by Ignyta for such period are more than one hundred five percent (105%) of the
Royalties actually paid for such period, then Ignyta shall pay the reasonable
fees and expenses charged by such accounting firm. Ignyta shall require each
Sublicensee (whether an Affiliate or a Third Party) to extend to Nerviano the
same audit rights as those described in this Section 5.2.

5.2.3 Nerviano shall cause its accounting firm to retain all financial
information subject to review under this Section 5.2 in strict confidence;
provided, however, that Ignyta shall have the right to require that such
accounting firm, prior to conducting such audit, enter into an appropriate
non-disclosure agreement with Ignyta regarding such financial information. The
accounting firm shall disclose to Nerviano only whether the reports are correct
or not and the amount of any discrepancy. No other information shall be shared.
Nerviano shall treat all such financial information as Ignyta’s Confidential
Information.

 

6. PAYMENTS

6.1 All payments due under this Agreement shall be paid in immediately available
funds in US Dollars to the bank account designated in writing by Nerviano. To
the extent Net Sales are accrued in currencies other than dollars, Net Sales
shall be converted to US Dollars using the average of the exchange rate (local
currency per US$1) published in The Wall Street Journal, Western Edition, under
the heading “Currency Trading” on the last business day of each month during the
applicable calendar quarter.

6.2 Payment Terms Royalties shown to have accrued by each Payment Report
provided for under Section 5 shall be due on the date such Payment Report is
due. Payment of Royalties in whole or in part may be made in advance of such due
date.

6.3 Exchange Control. If at any time legal restrictions prevent the prompt
remittance of part or all Royalties with respect to any country in the Territory
where the Product is sold, Ignyta shall have the right, in its sole discretion,
to make such payments by depositing the amount thereof in local currency to
Nerviano’s account in a bank or other depository institution in such country. If
the Royalty rate specified in this Agreement should exceed the permissible rate
established in any country, the Royalty rate for sales in such country shall be
adjusted to the highest legally permissible or government-approved rate.

6.4 Withholding Taxes. Ignyta shall be entitled to deduct the amount of any
withholding taxes, value-added taxes or other taxes, levies or charges with
respect to such amounts, other than United States taxes, payable by Ignyta, its
Affiliates or Sublicensees, or any taxes required to be withheld by Ignyta, its
Affiliates or Sublicensees, to the extent Ignyta, its Affiliates, or

 

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Sublicensees pay to the appropriate governmental authority on behalf of Nerviano
such taxes, levies or charges. Ignyta shall use reasonable efforts to minimize
any such taxes, levies or charges required to be withheld on behalf of Nerviano
by Ignyta, its Affiliates or Sublicensees. Ignyta promptly shall deliver to
Nerviano proof of payment of all such taxes, levies and other charges, together
with copies of all communications from or with such governmental authority with
respect thereto.

 

7. DEVELOPMENT

7.1 Joint Development Committee.

(a) Within 30 days following the Effective Date, Nerviano and Ignyta shall
appoint a Joint Development Committee (the “JDC”) to exchange information
regarding all activities related to the Development of the Products, including
to facilitate the transfer from Nerviano to Ignyta of Nerviano Know-How. The JDC
shall continue to be in effect until the receipt of the first NDA Approval for a
Product.

(b) The JDC will consist of four individuals of which two will be designated by
Nerviano and two will be designated by Ignyta. Ignyta has the right to designate
the chair of the JDC. One representative from each Party shall be a senior
executive from such Party, and the other representative shall be the project
leader from such Party. Each Party shall have the right, at any time, to
designate by written notice to the other Party, a replacement for any of such
Party’s members on the JDC. The JDC shall endeavor to work by consensus. Where
consensus cannot be reached, Ignyta shall make the final determination after
consultation with Nerviano and considering Nerviano’ position in good faith;
provided, however, that Ignyta shall not make any final determination that
conflicts with the terms and conditions of this Agreement. As of the time of the
establishment of the JDC, each Party shall also designate one of its members of
the JDC as the primary contact and coordinator for such Party, to facilitate
communication and coordination of the Parties’ activities under the Agreement
(the “Project Coordinator”).

(c) The JDC shall meet as necessary, but, in any event no less frequently than
twice each year. In lieu of in person meetings, meetings of the JDC may take
place by telephonic or video conference. The site for the in-person meetings
shall alternate between Nerviano, Italy and San Diego, California, or such other
location agreed to by the Parties. Other than with respect to special meetings
of the JDC, which may be called by either Party on not less than ten days prior
written notice (which notice may be by e-mail), the chairperson shall send to
the members of the JDC a notice of and agenda for each meeting at least five
business days prior to the date of such meeting.

(d) Promptly after each meeting of the JDC, the chairperson shall (or shall
designate another member of the JDC) to prepare and distribute, via facsimile or
e-mail to all members of the JDC, draft minutes, including action steps and
decisions, of the meeting. Promptly after the draft minutes are distributed, the
members shall either note their approval or provide proposed revisions to the
draft. Promptly after the receipt of all approvals or proposed revisions to the
draft, the chairperson shall issue the final minutes of the JDC.

 

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(e) Each Party shall bear its own costs, including travel, lodging, food and
telephone or video conference costs, for its personnel serving on the JDC or
attending any meeting of the JDC.

7.2 Nerviano Support. Commencing on or promptly following the Effective Date and
continuing throughout the term of this Agreement, Nerviano shall provide Ignyta
with Nerviano Know-How in its possession that is reasonably required to conduct
the Development of the Products, and is reasonably requested by Ignyta.

7.3 Regulatory Approvals. Ignyta, either on its own or through its Affiliates or
permitted Sublicensees, shall use Commercially Reasonable Efforts to (a) obtain
NDA Approvals for Products in each of the Major Market Countries; (b) compile,
submit and prosecute in a timely manner all necessary data, documents, NDAs
(including labeling), in a format acceptable to the applicable Competent
Authorities with respect to such NDA Approvals, except that if Ignyta requests
and to the extent that Nerviano has contributed to relevant parts of the CMC
section, then Nerviano shall assist Ignyta in completing the related CMC section
of the filings; and (c) maintain and renew the NDA Approvals obtained by Ignyta
and hold all such filings and approvals in its name, all at Ignyta’s expense.
Ignyta shall pay all user fees and other costs required to obtain and maintain
such NDA Approvals. Ignyta and its Affiliates may use and cross-reference any
Registrations held by Nerviano or its Affiliates for the Products.

7.4 On-Going Disclosure Regarding Development. Ignyta will keep Nerviano
informed about Ignyta’s or its Affiliate’s or Sublicensee’s, efforts to Develop
the Products, including summaries regarding Ignyta’s progress towards meeting
the pertinent goals and milestones discussed by the JDC. Such disclosures will
be made through the JDC at JDC meetings and in a written report to be attached
to or included in the minutes of each JDC meeting. Without limiting the
generality of the foregoing, such reports will contain the following: filing of
an IND or NDA with respect to a Product in any jurisdiction; initiation of any
clinical study with respect to a Product in any jurisdiction; and identification
of NDA Approvals in any jurisdiction.

7.5 Development Data.

(a) Promptly after the Effective Date, Nerviano shall transfer to Ignyta all
existing Development Data and during the term of this Agreement Nerviano shall
promptly and consistently transfer to Ignyta all Development Data as and when
generated or developed. Ignyta shall be the sole owner of the Development Data
and Nerviano does and hereby assigns to Ignyta all of its right, title and
interest therein.

(b) Both Parties shall develop and maintain the Development Data, related
records, documents and raw data in sufficient detail and in good scientific
manner as will properly reflect all work done and results achieved in the
development of the APIs and Products.

 

8. MANUFACTURE

8.1 Product Supply. Ignyta shall have the right to manufacture or engage a third
party manufacturer for the supply of the APIs or Products.

8.2 DMF. To the extent required CMC information is not contained in any IND
submitted to the FDA, Ignyta shall establish with the FDA a drug master file for
the Product (“DMF”) and, if

 

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requested by Ignyta, and to the extent that Nerviano has contributed to relevant
parts of the CMC section, Nerviano shall assist Ignyta in obtaining the DMF.

8.3 [***]

 

9. CONFIDENTIALITY

9.1 Confidential Information. During the term of this Agreement, and for a
period of five (5) years following the expiration or earlier termination hereof,
each Party shall maintain in confidence all information of the other Party that
is disclosed by the other Party and identified as, or acknowledged to be,
confidential at the time of disclosure (the “Confidential Information”), and
shall not use, disclose or grant the use of the Confidential Information except
on a need-to-know basis to those directors, officers, Affiliates, employees,
permitted licensees, permitted assignees and agents, consultants, clinical
investigators or contractors, to the extent such disclosure is reasonably
necessary in connection with performing its obligations or exercising its rights
under this Agreement. To the extent that disclosure is authorized by this
Agreement, prior to disclosure, each Party hereto shall obtain agreement of any
such Person to hold in confidence and not make use of the Confidential
Information for any purpose other than those permitted by this Agreement. Each
Party shall notify the other promptly upon discovery of any unauthorized use or
disclosure of the other Party’s Confidential Information.

9.2 Permitted Disclosures. The confidentiality obligations contained in
Section 9.1 shall not apply to the extent that (a) any receiving Party (the
“Recipient”) is required (i) to disclose information by law, regulation or order
of a governmental agency or a court of competent jurisdiction, provided that the
Recipient shall provide written notice thereof to the other Party and sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof, or (ii) to disclose information to any governmental agency
for purposes of obtaining approval to test or market a product; or (b) to
disclose to its employees, directors, consultants, Sublicensees or Affiliates
who have a need to know for purposes of this Agreement and are under an
obligation of confidentiality equivalent to that of the Recipient.
Notwithstanding any other provision of this Agreement, Ignyta may disclose
Confidential Information of Nerviano relating to information developed pursuant
to this Agreement to any Person with whom Ignyta has, or is proposing to enter
into, a business relationship, as long as such Person has entered into a
confidentiality agreement with Ignyta.

9.3 Disclosure of Financial and Other Terms. Except as required by applicable
laws, treaties and agreements (including securities laws), the Parties agree
that the material terms of this Agreement will be considered Confidential
Information of both Parties. Notwithstanding the foregoing, (a) either Party may
disclose such terms as are required to be disclosed in its publicly-filed
financial statements or other public statements, pursuant to applicable laws,
regulations and stock exchange rules (e.g., the U.S. Securities and Exchange
Commission, NASDAQ, NYSE, or any other stock exchange on which securities issued
by Ignyta or Nerviano may be issued);

 

 

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provided, such Party shall provide the other Party with a copy of the proposed
text of such statements or disclosure (including any exhibits containing this
Agreement) sufficiently in advance of the scheduled release or publication
thereof to afford such other Party a reasonable opportunity to review and
comment upon the proposed text (including redacted versions of this Agreement),
(b) either Party shall have the further right to disclose the material financial
terms of this Agreement on a confidential basis to any potential and actual
Sublicensee, Acquiror, merger partner or potential providers of financing and
their advisors in connection with due diligence investigations by, or
presentations to, such entities, and (c) either Party shall have the right to
disclose information regarding the development or commercialization status of a
Product to the extent such disclosure is customary and material to their
potential and actual Sublicensees, current investors, or required by applicable
laws or stock exchange rules. Neither Party shall make any other statement to
the public regarding the execution and/or any other aspect of the subject matter
of this Agreement, except: (x) where a Party reasonably believes disclosure is
required under applicable laws or ethical commercial practice, (y) for customary
discussions with current or prospective investors and analysts, and (z) either
Party may use the text of a statement previously approved by the other Party.
Promptly after the Effective Date, the Parties will draft and issue a mutually
acceptable press release.

9.4 Publication. Nerviano shall not publish, present or disclose any data,
information or results regarding the APIs or their use without the prior written
consent of Ignyta. If Nerviano desires to make any such publication,
presentation or disclosure, Nerviano shall first submit to Ignyta for its
review, a copy of any proposed publication, presentation or other disclosure at
least thirty (30) days prior to the date of submission for publication,
presentation or other disclosure. If Ignyta gives written notice to Nerviano
that it does not desire that the data, information or results be published,
presented or otherwise disclosed, or Ignyta requests that certain of such data,
information or results be removed for confidentiality or patent filing purposes,
then Nerviano will not make such publication, presentation or other disclosure
or will remove such data, information or results, as applicable.

 

10. INTELLECTUAL PROPERTY

10.1 Trademarks. Ignyta shall select and own the trademarks used on the Products
(the “Product Trademarks”); provided, that no Product Trademark shall be the
same as or confusingly similar to a trademark used by Nerviano as of the date of
Ignyta’s intended first use for any of its other products nor contain the phrase
“Nerviano Medical Sciences.”

10.2 Ownership of Inventions. Subject to the terms hereof, including the
licenses and other rights granted hereunder, all Inventions shall be owned as
follows:

(a) Nerviano shall own the entire right, title and interest in and to all
Inventions (including all patents and other intellectual property rights
thereto) made solely by its employees or others acting on behalf of Nerviano (or
solely by such persons and Third Parties performing work for Nerviano) in the
Development of Products or other activities undertaken under this Agreement
(“After-Developed Nerviano Inventions”). All After-Developed Nerviano Inventions
will be included in the licenses and rights granted under Article 3 above;

 

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(b) Ignyta shall own the entire right, title and interest in and to all
Inventions (including all patents and other intellectual property rights
thereto) made solely by its employees or others acting on behalf of Ignyta (or
solely by such persons and Third Parties performing work for Ignyta) in the
Development of Products or other activities undertaken under this Agreement;

(c) The Parties shall jointly own all Joint Inventions (as defined below).
Nerviano’ rights in and to each Joint Invention (including all patent rights and
other intellectual property rights to it) will be included in the licenses and
rights granted under Article 3 above, and, subject to such license and rights,
each Party may make, use, sell, keep, license or assign its interest in Joint
Inventions and otherwise undertake all activities a sole owner might undertake
with respect to such Joint Inventions, without the consent of and without
accounting to the other Party. “Joint Inventions” means Inventions for which it
is determined, in accordance with United States patent law, that both: (i) one
or more employees, consultants or agents of Nerviano or any other persons
obligated to assign such Invention to Nerviano; and (ii) one or more employees,
consultants or agents of Ignyta or any other persons obligated to assign such
Invention to Ignyta, are joint inventors.

10.3 Prosecution of Patents.

(a) Sole Inventions. Subject to the provisions of paragraphs (b) and (c) below,
each Party shall have the right to: (i) determine whether patent applications
should be filed on Inventions owned by it (other than Joint Inventions), and if
so, where and when; (ii) control the prosecution and procurement of any such
patents and any other Nerviano Patents, in the case of Nerviano, including their
issuance, reissuance, reexamination and the defense of any interference,
revocation or opposition proceedings, and to decide in which countries to
maintain such patents when issued and for how long; and (iii) select all counsel
or other parties necessary to prepare, file, prosecute and maintain all Nerviano
Patents, in the case of Nerviano, or to advise or represent it in connection
with such patent applications or patents. Ignyta shall reimburse Nerviano for
the reasonable costs and expenses of filing, prosecuting and maintaining the
Nerviano Patents except for any Post Grant Proceedings, which will be negotiated
in good faith on a case-by-case basis, but Ignyta shall not be liable for such
costs unless the parties have reached agreement. For the purpose of this Article
10.3, “prosecution” shall include any post-grant proceeding including patent
interference proceeding, inter partes review, opposition proceeding and
reexamination (collectively, “Post Grant Proceedings”).

(b) Joint Inventions. Ignyta shall be responsible for filing patent applications
on, and directing the particulars (as described in Section 10.3(a)) of the
patent prosecution for all Joint Inventions at its own cost and expense. Ignyta
will exercise its reasonable efforts to keep Nerviano informed of significant
steps taken in such matters. With respect to the prosecution of patent
applications for Joint Inventions, Ignyta shall have the further right to take
such actions as are necessary or appropriate to procure and maintain patents
with respect thereto. All patent applications and patents directed to Joint
Inventions (“Joint Patents”) shall be owned jointly between Nerviano and Ignyta.
Upon request, unless and to the extent otherwise mutually agreed by each Party’s
patent counsel, Ignyta, to the extent practicable, shall furnish Nerviano with
copies of such Joint Patents and other related correspondence relating to the
prosecution of the Joint Patents to and from patent offices throughout the
Territory, and permit Nerviano to offer its comments thereon before Ignyta makes
a submission to a patent office. Nerviano shall offer its

 

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comments promptly, including any request that the patents be filed in additional
countries, although Ignyta shall determine the appropriate action after
considering in good faith any comments or requests from Nerviano. If, in its
sole discretion, Ignyta decides not to file a patent application on any Joint
Invention, or ceases to diligently pursue prosecution or procurement, or fails
to maintain the same in any country, that decision, cessation, or failure will
not constitute a default under this Agreement. Rather, Nerviano shall then have
the right, at its sole expense and in its sole discretion, to file patent
applications, control prosecution and procurement, and maintain procured patents
with respect to such Joint Invention. In respect of Joint Inventions, Ignyta
shall pay all costs and expenses incurred in respect of patents prosecuted or
maintained by it.

(c) Nerviano Patents. Nerviano shall prepare, prosecute and maintain all
Nerviano Patents. Nerviano will exercise its reasonable efforts to keep Ignyta
currently informed of significant steps to be taken in such preparation,
prosecution and maintenance of all Nerviano Patents. Upon request, unless and to
the extent otherwise mutually agreed by each Party’s patent counsel, Nerviano,
to the extent practicable, shall furnish Ignyta with copies of such Patents and
other related correspondence relating to the prosecution of all Nerviano Patents
to and from patent offices, and permit Ignyta to offer its comments thereon
before Nerviano makes a submission to a patent office. Nerviano will reasonably
incorporate the comments received from Ignyta. Ignyta will have the right to
choose which countries in which to file patent applications, provided that
Nerviano shall file in the following countries: countries in the European Patent
Convention, U.S., Japan, Australia, India, Mexico, Canada, Brazil, Chile, China
(including Hong Kong), Thailand, South Korea, and the following EAPC countries:
Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrghyz Republic, Republic of Moldova,
Russia, Tajikistan and Turkmenistan. Ignyta shall offer its comments promptly,
including the list of additional countries. Subject to its antecedent
obligations below, Nerviano may discontinue the prosecution of any patent
application or abandon any patent encompassed within the Nerviano Patents. If
Nerviano decides not to file or to abandon or allow to lapse any patent
application or patent within the Nerviano Patents in any country of the
Territory, Nerviano will promptly inform Ignyta of such decision and in the case
of abandonment, at least 30 days prior to such abandonment or lapse and will
give Ignyta the opportunity to prosecute such patent application and/or maintain
such patent at its expense and in Ignyta’s name. If Ignyta elects to undertake
the prosecution of any Nerviano Patent, Nerviano will assign its right, title
and interest in and to the pertinent Nerviano Patent to Ignyta, whereupon Ignyta
will have no further obligation under this Agreement with respect to the payment
of Royalties or otherwise pertaining to that Nerviano Patent.

10.4 Patent Term Extensions.

The Parties shall: (a) notify each other of the issuance of each patent where
extension is possible included within the Nerviano Patents or Joint Patents,
giving the date of issue and patent number for each such patent; and (b) advise
each other in a timely manner of NDA Approval by the FDA, EMA, or MHLW for any
Product and any other governmental approval that is pertinent to any patent term
extension or restoration. The Parties shall use reasonable efforts to obtain all
available patent term extensions or restorations of such Nerviano Patents or
Joint Patents (including those available under the Hatch-Waxman Act). To that
end, each Party shall: (c) supply the other Party, in a timely manner, with any
information in its possession or control pertaining to, or desirable for, the
extension of any Nerviano Patents or Joint Patent; (d) execute

 

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and deliver to the other Party, in a timely manner, any authorizations,
supporting affidavits and other documents required in connection with the
extension of any Nerviano Patent or Joint Patent; and (e) take such other
actions as may be reasonably requested by the other Party to obtain such
extensions. The Parties shall cooperate with each other in seeking or gaining
patent term restorations or extensions wherever applicable to such Nerviano
Patents or Joint Patents, and in determining which Nerviano Patents or Joint
Patents the Parties should seek and obtain patent term extension or restoration.
The Party first eligible to seek patent term restoration or extension of any
such Nerviano Patents or Joint Patents related thereto shall have the right to
do so; provided, that if in any country the first Party has an option to extend
the patent term for only one of several patents, the first Party will consult
with the other Party before making the election. If more than one Nerviano
Patents or Joint Patents (or other patents) is eligible for extension or patent
term restoration, the Parties shall agree upon a strategy that will maximize
patent protection for the Product.

10.5 Patent Certifications.

(a) Each Party shall immediately give notice to the other Party of any notice it
receives of certification filed under the Hatch-Waxman Act (or substantially
similar foreign law or regulation) claiming that any of the Ignyta Patents,
Nerviano Patents or Joint Patents is invalid, unenforceable or that any
infringement will not arise from the manufacture, use or sale of a Product by a
Third Party. The right to bring suit against the entity making such a
certification shall be governed by Section 10.6. Any suit by either Party may be
in the name of either or both Parties, as may be required by law. For this
purpose, the Party not bringing suit shall execute such legal papers necessary
for the prosecution of such suit as may be reasonably requested by the Party
bringing suit.

(b) To the extent required by law or permitted by law, Ignyta shall use its
Commercially Reasonable Efforts to maintain with the applicable regulatory
authorities during the term of this Agreement correct and complete listings of
applicable patents for any Product then being commercialized by Ignyta,
including all so called “Orange Book” listings required under the Hatch-Waxman
Act.

10.6 Enforcement of Patent Rights.

(a) In the event that either Party becomes aware of any product containing the
APIs that is made, used, or sold in the Territory which it believes to
(i) infringe an Ignyta Patent, a Nerviano Patent or a Joint Patent, or
(ii) constitute a misappropriation of know-how covering the use of any of the
APIs or any Product in the Field, such Party (the “Notifying Party”) will
promptly advise the other Party of all the relevant facts and circumstances
known by the Notifying Party in connection with the infringement or
misappropriation.

(b) Ignyta may enforce, and Nerviano does hereby grant to Ignyta the right to
enforce as applicable, such Ignyta Patents, Nerviano Patents or Joint Patents
against such infringement or misappropriation in the Territory at Ignyta’s sole
expense and in Ignyta’s sole discretion. Nerviano and its Affiliates will fully
cooperate with Ignyta with respect to the investigation and prosecution of such
alleged infringement or misappropriation by Ignyta including the joining of
Nerviano and its Affiliates as a Party to such action, as may be required by the
law of the

 

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particular forum where enforcement is being sought.

(c) Nerviano shall, at its sole expense and in its sole discretion, enforce such
Nerviano Patents and Joint Patents against such infringement or misappropriation
in the Territory if: (i) within 120 days (or such shorter time as would allow
Nerviano to reasonably bring suit before any legal or regulatory deadline
therefore) after receiving notice from Nerviano of the infringement or
misappropriation, Ignyta elects, in its sole discretion, not to take action to
investigate such alleged infringement or misappropriation and, if such
infringement or misappropriation is subsequently reasonably demonstrated, to
timely institute an action to abate such alleged infringement or
misappropriation and to prosecute such action diligently, or (ii) Ignyta
notifies Nerviano that Ignyta does not plan to terminate the infringement or
misappropriation or institute such action. Ignyta and its Affiliates will fully
cooperate with Nerviano with respect to the investigation and prosecution of
such alleged infringement or misappropriation including the joining of Ignyta
and its Affiliates as a Party to such action, as may be required by the law of
the particular forum where enforcement is being sought.

(d) The Party prosecuting such infringement or misappropriation action will
control the litigation and will bear all legal expenses (including court costs
and legal fees and expenses), including settlement thereof; provided, that no
settlement or consent judgment or other voluntary final disposition of any
infringement or misappropriation action brought by a Party pursuant to this
Section 10.6 may be entered into without the prior written consent of the other
Party if such settlement would require the other Party to be subject to an
injunction or to make a monetary payment in excess of $50,000 or would restrict
the claims in or admit any invalidity of any of the Nerviano Patents or Joint
Patents or significantly adversely affect the rights of the other Party to this
Agreement.

(e) Any recovery obtained as a result of such action, whether by judgment,
award, decree or settlement will first be applied to reimbursement of each
Party’s out-of-pocket expenses in bringing such suit or proceeding, and 75% of
the remaining balance shall be distributed to the Party bringing such
enforcement action, and 25% to the other Party.

10.7 Patent Infringement Claims.

(a) Each Party shall notify the other Party promptly in writing of any claim of,
or action for, infringement of any patents or misappropriation of trade secret
rights of any Third Party which is threatened, made or brought against either
Party by reason of the development, manufacture, use or sale of any Product by
either Party. Ignyta shall be responsible for defense of all such claims against
Ignyta in the Territory except as otherwise provided in Article 12.

(b) In any suit, action or proceeding referred to in this Section 10.7
(regardless of which Party commences or defends), each Party shall, at its own
expense, fully cooperate with the other Party and supply all assistance
reasonably requested by the Party carrying on the proceeding, including
providing the other Party with such witnesses, documents and records and other
evidence as may be reasonably requested.

10.8 Cooperation. In any suit to enforce and/or defend the Licensed IP Rights or
the Ignyta Patents pursuant to this Section 10, the Party not in control of such
suit shall, at the request and

 

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expense of the controlling Party, reasonably cooperate and, to the extent
possible, have its employees testify when requested and make available relevant
records, papers, information, samples, specimens, and the like.

 

11. TERMINATION

11.1 Term of Agreement. This Agreement shall become effective as of the
Effective Date and, unless earlier terminated pursuant to other provisions of
this Article 11, shall continue in full force and effect until Ignyta has duly
and completely fulfilled its obligation to pay Royalties to Nerviano under
Section 4.2. Following expiration of this Agreement - unless terminated in
advance according to the provisions of present Article 11 - Ignyta shall have a
fully paid-up, non-exclusive license under the Nerviano Know-How to conduct
research and to develop, make, have made, use, sell, offer for sale and import
Products in the Territory for use in the Field.

11.2 Termination by Ignyta. The Agreement may be terminated by Ignyta at any
time as follows:

(a) prior to the First Commercial Sale of a Product, Ignyta may terminate this
Agreement upon providing Nerviano with sixty (60) day written notice of its
intent to terminate; or

(b) after the First Commercial Sale of a Product, Ignyta may terminate this
Agreement upon three months prior written notice: provided, that Nerviano may
then accelerate the effective date of termination to not less than 30 days after
such notice from Ignyta.

11.3 Termination for Cause. Upon the material breach by one Party under this
Agreement, the other Party shall notify the breaching Party of such breach, and
require that the breaching Party cure such breach within 60 days (or, in the
case of payment defaults, within 30 days), provided that, in the case of any
default other than the payment default, such cure period shall be reasonably
extended (not to exceed 120 days) if, despite the commercially reasonable
efforts of the breaching Party, such default may not be cured within such 60 day
period. In the event that the material breach is not cured within the applicable
cure period, the notifying Party shall be entitled, without prejudice to any of
its other rights conferred on it by this Agreement and any other remedies
available to it by law or in equity, to terminate this Agreement.

11.4 Effect of Termination.

(a) Upon termination by Ignyta pursuant to Section 11.2 or by Nerviano pursuant
to Section 11.3:

(i) All sublicenses granted by Ignyta to its Sublicensees under this Agreement
pursuant to Section 3.3 shall survive the termination of this Agreement provided
that such Sublicensees are not in breach of their respective Sublicense
Agreements and assume in writing all obligations under such Sublicense
Agreements to Nerviano directly; and

(ii) All rights and licenses granted by Nerviano to Ignyta will terminate.

(iii) Ignyta will assign to Nerviano all regulatory filings and NDA Approvals
for the Products and the Development Data;

 

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(iv) If termination occurs after submission of materials seeking NDA Approval
for any Products, all rights to all Product Trademarks for use with the Product
(excluding Ignyta’s name) will be assigned to Nerviano;

(v) Ignyta will, at Nerviano’s option, transfer to Nerviano responsibility for
any then-ongoing clinical trials of Products in which patient dosing has
commenced, and Nerviano shall be solely responsible for the costs of conducting
such trials incurred after the effective date of termination of this Agreement;

(vi) Ignyta shall grant to Nerviano a royalty-bearing, exclusive license (with
right to sublicense) under the Joint Inventions, Ignyta Patents and Ignyta
Know-How existing as of the date of termination solely for the APIs or their
manufacture or use in any indication (and no other active pharmaceutical
ingredient or diagnostic).

(vii) If Ignyta has commenced a Phase II Clinical Trial as of the date of
termination, then Nerviano shall pay Ignyta royalties of [***] of annual Net
Sales (as such definition is revised to encompass sales by Nerviano or its
Affiliates or sublicensees).

Ignyta will cooperate in any reasonable manner requested by Nerviano to achieve
a smooth transition of the development, manufacturing, marketing and sales of
Products to Nerviano or its licensees, such as transfer of manufacturing
technology and assistance in connection with regulatory matters relating to the
transfer of Products.

(b) Following termination of this Agreement by Ignyta pursuant to Section 11.3,
Ignyta shall have a fully-paid, royalty-free, exclusive license under the
Nerviano Know-How, the Nerviano Patents and the Joint Patents to conduct
research and to develop, make, have made, use, sell, offer for sale and import
Products in the Territory for use in the Field.

11.5 Surviving Provisions. The following Articles and Sections of this Agreement
shall survive any expiration or termination of this Agreement for any reason:
Sections 2.4, 9, 10.2, 11.4, 11.5, 12 and 13.

 

12. INDEMNIFICATION

12.1 Mutual Indemnification. Each Party shall defend, indemnify and hold the
other Party and its Affiliates, and their respective directors, officers,
employees, agents, contractors, sublicensees, and consultants harmless from and
against any and all liabilities, losses, damages, settlements, claims, actions,
suits, penalties, fines, costs or expenses (including reasonable attorneys’ fees
and other expenses of litigation actually incurred) arising out of any claim or
action brought by a Third Party (any of the foregoing, a “Loss”) arising out of
or resulting from:

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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(a) the negligence, recklessness or intentional acts or omissions of the
indemnifying Party and its Affiliates, and their respective directors, officers,
employees and agents with respect to this Agreement and the transactions
contemplated hereby;

(b) any breach of a representation, warranty, covenant or agreement of the
indemnifying Party hereunder; and

(c) any personal injury or property damage occurring at a location owned,
leased, or under the control of the indemnifying Party in connection with the
transactions contemplated by this Agreement (except to the extent such Loss
arose out of or resulted from the negligence, recklessness or intentional acts
or omissions of the other Party or its Affiliates, and their respective
directors, officers, employees and agents).

12.2 Ignyta. Except to the extent required to be indemnified by Nerviano under
Section 12.3, Ignyta shall defend, indemnify and hold Nerviano, its Affiliates,
and their respective directors, officers, employees and licensees, harmless from
and against any and all Losses arising out of the development, non-clinical or
clinical testing, use or sale of Products in the Territory by Ignyta or its
Affiliates or Sublicensees, including any patent infringement or product
liability claims (including any product defects, failure to comply with
regulatory and other legal requirements, failure to provide adequate warnings
and misuse of the Products); except the foregoing obligations of Ignyta will not
apply to any Loss that arises from, or is due to any of: (a) actions or claims
alleging that any action or inaction of Nerviano infringes any patent rights of
any Third Party; (b) Nerviano’s breach of its obligations under this Agreement,
including its representations and warranties; or (c) Nerviano’s negligence or
willful misconduct.

12.3 Nerviano. Nerviano shall defend, indemnify and hold Ignyta, its Affiliates,
and their respective directors, officers, employees, and licensees, harmless
from and against any and all Losses to which such persons may become subject as
a result of any claim, demand, action or other proceeding by any Third Party to
the extent such Losses arise out of (a) a claim that any action or inaction of
Nerviano infringes any patent rights of any Third Party; (b) Nerviano’s breach
of its obligations under this Agreement, including its representations and
warranties; or (c) Nerviano’ negligence or willful misconduct.

12.4 Indemnification Procedure. In the event that either Party seeks
indemnification under this Article 12, such Party shall inform the other Party
of the claim as soon as reasonably practicable after it receives notice of the
claim and, in any event, not later than 20 days after it receives such notice,
and shall (a) permit the indemnifying Party to assume direction and control of
the defense of the claim (including the right to settle such claim at its
discretion; provided, that no such settlement may be entered into without the
indemnified Party’s consent if such settlement may adversely impact such Party’s
rights hereunder), and (b) cooperate as requested (at the expense of the
indemnifying Party) in the defense of such claim. If both Parties are sued and
it is reasonably likely that the Parties may have conflicting interests or if it
is otherwise not advisable under applicable legal and ethical requirements for
the indemnifying Party’s defense counsel to represent both Parties, separate
independent counsel shall be retained for each Party at the expense of the
indemnifying Party.

 

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12.5 Insurance. Immediately upon the first administration of any API or Product
to a human in the Territory by Ignyta, its Affiliates or its Sublicensees, and
for a period of three (3) years after the filing of an NDA in all Major Market
Countries, Ignyta shall obtain and maintain, at its sole cost and expense,
clinical trial insurance standard in the pharmaceutical trade in amounts of at
least [***] per occurrence (or claim) and [***] in the aggregate limit of
liability per year. Prior to the first NDA Approval, and for a period of five
(5) years after the expiration of this Agreement or the earlier termination
thereof, Ignyta shall obtain and maintain, at its sole cost and expense, product
liability insurance standard in the pharmaceutical trade in amounts of at least
[***] per occurrence (or claim) and [***] in the aggregate limit of liability
per year. Ignyta shall provide written proof of the existence of such insurance
to Nerviano upon request. If Ignyta sublicenses its rights to sell a Product in
accordance with Section 3.3, such insurance obligations may be satisfied by its
Sublicensees.

 

13. MISCELLANEOUS

13.1 Notices. Any consent, notice or report required or permitted to be given or
made under this Agreement by one of the Parties hereto to the other Party shall
be in writing, delivered by any lawful means to such other Party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and (except as otherwise provided in this
Agreement) shall be effective upon receipt by the addressee.

 

         If to Nerviano:

  

Nerviano Medical Sciences S.r.l.

  

Viale Pasteur 10

  

20014 Nerviano (Milano)

  

Italy

  

Attention: Chief Executive Officer

  

With required copy to:

  

Nerviano Medical Sciences S.r.l.

  

Viale Pasteur 10

  

20014 Nerviano (Milano)

  

Italy

  

Attention: Head of Business Development

         If to Ignyta:

  

Ignyta, Inc.

  

11095 Flintkote Avenue, Suite D

  

San Diego, CA 92121, U.S.A

  

Attention: Chief Executive Officer

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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13.2 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York (USA), without regard to the
conflicts of law principles thereof.

13.3 Force Majeure. Neither Party shall be held liable or responsible to the
other Party nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement to the
extent, and for so long as, such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party including but not
limited to fire, floods, embargoes, war, acts of war (whether war be declared or
not), acts of terrorism, insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts, omissions or delays
in acting by any governmental authority or the other Party; provided, that the
Party so affected shall give prompt notice thereof to the other. If any such
cause prevents either Party from performing any of its material obligations
hereunder for more than six months, the other Party may then terminate this
Agreement upon 90 days prior notice. Except as provided in the immediately
preceding sentence, no such failure or delay shall terminate this Agreement, and
each Party shall complete its obligations hereunder as promptly as reasonably
practicable following cessation of the cause or circumstances of such failure or
delay.

13.4 Dispute Resolution.

(a) The Parties recognize that a bona fide dispute as to certain matters may
from time to time arise during the term of this Agreement that relate to any
Party’s rights or obligations hereunder. In the event of the occurrence of any
dispute arising out of or relating to this Agreement, including any question
regarding its existence, validity or termination, any Party may, by written
notice to the other, have such dispute referred to their respective officer
designated below or their successors, for attempted resolution by good faith
negotiations within sixty (60) days after such notice is received. Said
designated officers are as follows:

For Nerviano: Chief Executive Officer

For Ignyta: Chief Executive Officer

(b) In the event that they shall be unable to resolve the dispute by executive
mediation within thirty (30) days of the disputing Party’s notice, then the
dispute shall be finally settled by binding arbitration as provided below. The
arbitration shall be conducted in English. The award of arbitration shall be
final and binding upon both Parties.

(c) Any arbitration proceeding shall be conducted in accordance with the
arbitration rules of the London Court of International Arbitration (“LCIA”). The
place of arbitration shall be London, England. The procedures specified in this
Section 13.4 shall not prevent either Party from seeking preliminary or
permanent injunctive relief with respect to breaches of obligations under this
Agreement in any appropriate jurisdiction.

13.5 Assignment. Ignyta shall not assign its rights or obligations under this
Agreement without the prior written consent of Nerviano; provided, however, that
each Party may assign without prior written consent, this Agreement and its
rights and obligations hereunder (a) to any Affiliate, or (b) in connection with
the transfer or sale of all or substantially all of its business to which this
Agreement relates, or in the event of its merger, consolidation, change in
control or

 

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similar transaction. Any attempt to assign this Agreement in breach of the
foregoing shall be void. This Agreement shall be binding upon and inure to the
benefit of the Parties hereto and each of their successors and permitted
assigns.

13.6 Waivers and Amendments. No change, modification, extension, termination or
waiver of this Agreement, or any of the provisions herein contained, shall be
valid unless made in writing and signed by duly authorized representatives of
the Parties hereto.

13.7 Entire Agreement. This Agreement embodies the entire agreement between the
Parties and supersedes any prior representations, understandings and agreements
between the Parties regarding the subject matter hereof. There are no
representations, understandings or agreements, oral or written, between the
Parties regarding the subject matter hereof that are not fully expressed herein.

13.8 Severability. Any of the provisions of this Agreement which are determined
to be invalid or unenforceable in any jurisdiction shall be ineffective to the
extent of such invalidity or unenforceability in such jurisdiction, without
rendering invalid or unenforceable the remaining provisions hereof and without
affecting the validity or enforceability of any of the terms of this Agreement
in any other jurisdiction.

13.9 Waiver. The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.

13.10 Counterparts. This Agreement 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.

13.11 No Third-Party Beneficiaries. None of the provisions of this Agreement
shall be for the benefit of, or enforceable by, any Third Party. The agreements
herein contained are made for the sole benefit of the Parties hereto and no
other person or entity is intended to or shall have any rights or benefits
hereunder, whether as a third-party beneficiary or otherwise.

[SIGNATURE PAGE FOLLOWS]

 

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IN WITNESS WHEREOF, the Parties have executed this Agreement effective as of the
Effective Date.

 

NERVIANO MEDICAL SCIENCES By:  

/s/ Dr. Luciano Baielli

Name: Dr. Luciano Baielli Title: Amministratore Delegato IGNYTA, INC. By:  

/s/ Jonathan Lim

Name: Jonathan Lim Title: President and CEO

 

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EXHIBIT 1.3

[***]

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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EXHIBIT 1.27

[***]

 

 

*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

 

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This document contains confidential information belonging to Nerviano Medical
Sciences S.r.l.. Except as may be otherwise agreed to in writing, by accepting
or reviewing these materials, you agree to hold such information in confidence
and not to disclose it to others (except where required by applicable law), nor
to use it for unauthorized purposes. In the event of actual or suspected breach
of this obligation, Nerviano Medical Sciences S.r.l. should be promptly
notified.

 

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