[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Exhibit 10.2

LICENSE AND COLLABORATION AGREEMENT

by and between

SUMMIT (OXFORD) LTD

and

SAREPTA THERAPEUTICS, INC.

 

Dated as of October 3, 2016

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

TABLE OF CONTENTS

1.

DEFINITIONS1

2.

DEVELOPMENT COLLABORATION14

3.

REGULATORY MATTERS.22

4.

COMMERCIALIZATION OF THE LICENSED PRODUCTS24

5.

COLLABORATION MANAGEMENT28

6.

MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCT32

7.

LICENSES; EXCLUSIVITY35

8.

CERTAIN FINANCIAL TERMS40

9.

CONFIDENTIALITY AND PUBLICATION50

10.

REPRESENTATIONS, WARRANTIES AND COVENANTS52

11.

INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE56

12.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND
RELATED MATTERS58

13.

TERM AND TERMINATION65

14.

MISCELLANEOUS73

 

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

EXHIBIT & SCHEDULES

Exhibit A Development Plan and Budget (to be attached upon JSC approval)

Schedule 1.34University of Oxford Option Agreement

Schedule 1.64Option Data Package

Schedule 1.89Summit Patent Rights

Schedule 6.2Supply Agreement Terms

Schedule 9.2.3Joint Press Release

 

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

LICENSE AND COLLABORATION AGREEMENT

THIS LICENSE AND COLLABORATION AGREEMENT (this “Agreement”), effective as of
October 3, 2016 (the “Effective Date”), is entered into by and between Summit
(Oxford) Ltd, a company organized and existing under the laws of England and
Wales (“Summit”) and, Sarepta Therapeutics, Inc., a corporation organized and
existing under the laws of Delaware (“Sarepta”).

RECITALS:

WHEREAS, Summit is a clinical stage biotechnology company that has domain
expertise in utrophin modulation, owns or controls certain key intellectual
property relating to utrophin modulator compounds and is developing proprietary
therapeutic products in the Field (as defined below);

WHEREAS, Sarepta is a pharmaceutical company that has expertise and capabilities
in researching, developing and marketing RNA-based technologies for DMD (as
defined below) and infectious diseases;

WHEREAS, the Parties desire to collaborate to discover and develop
first-in-class and best-in-class utrophin modulators for DMD and BMD (as defined
below);

WHEREAS, Sarepta desires to develop and commercialize such utrophin modulators
in the Sarepta Territory (as defined below); and

WHEREAS, Summit desires to develop and commercialize such utrophin modulators in
the Summit Territory (as defined below).

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

1.

DEFINITIONS

Unless specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective meanings set
forth below:

1.1.

“Act in Concert” has the meaning ascribed thereto in the City Code.

1.2.

“Affiliate” means, with respect to a Person, any other Person which controls, is
controlled by, or is under common control with the applicable Person. For
purposes of this definition, “control” shall mean: (a) in the case of corporate
entities, direct or indirect ownership of at least fifty percent (50%) of the
stock or shares (or such lesser percentage which is the maximum allowed to be
owned by a foreign corporation in a particular jurisdiction) entitled to vote
for the election of directors, or otherwise having the power to control or
direct the affairs of such Person; and (b) in the case of non-corporate
entities, direct or indirect ownership of at least fifty percent (50%) of the
equity interest or the power to direct the management and policies of such
non-corporate entities.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.3.

“API Bulk Drug Substance” means a Collaboration Compound in bulk form
manufactured for use as an active pharmaceutical ingredient.

1.4.

“Benzoxazole Collaboration Compound” means ezutromid [**].

1.5.

“Benzoxazole Licensed Product” means each product comprising or containing a
Benzoxazole Collaboration Compound; [**].

1.6.

“BMD” means Becker Muscular Dystrophy.

1.7.

“Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31 of
each Calendar Year; provided that (a) the first Calendar Quarter of the Term
shall begin on the Effective Date and end on the December 31st thereafter and
the last Calendar Quarter of the Term shall end on the last day of the Term and
(b) the first Calendar Quarter of a Royalty Term for a Licensed Product in a
country shall begin on the First Commercial Sale of a Licensed Product in such
country and end on the first to occur of March 31, June 30, September 30 or
December 31 thereafter and the last Calendar Quarter of a Royalty Term shall end
on the last day of such Royalty Term in such country.

1.8.

“Calendar Year” means each successive period of twelve (12) months commencing on
January 1 and ending on December 31; provided that (a) the first Calendar Year
of the Term shall begin on the Effective Date and end on the first December 31
thereafter and the last Calendar Year of the Term shall end on the last day of
the Term and (b) the first Calendar Year of a Royalty Term for a Licensed
Product in a country shall begin on the First Commercial Sale of a Licensed
Product in such country and end on the first December 31 thereafter and the last
Calendar Year of the Term shall end on the last day of such Royalty Term in such
country.

1.9.

“Change of Control” shall occur with respect to a Party if: (a) any Third Party
acquires directly or indirectly the beneficial ownership of any voting security
of such Party, or if the percentage ownership of such Third Party in the voting
securities of such Party is increased through stock redemption, cancellation or
other recapitalization, and immediately after such acquisition or increase such
Third Party is, directly or indirectly, the beneficial owner of voting
securities representing more than fifty percent (50%) of the total voting power
of all of the then outstanding voting securities of such Party; (b) a merger,
consolidation, recapitalization or reorganization of such Party is consummated,
other than any such transaction, which would result in shareholders or equity
holders of such Party immediately prior to such transaction, owning at least
fifty percent (50%) of the outstanding voting securities of the surviving entity
(or its parent entity) immediately following such transaction; (c) the
shareholders or equity holders of such Party approve a plan of complete
liquidation of such Party, or an agreement for the sale or disposition by such
Party of all or substantially all of such Party’s assets, other than pursuant to
the transaction described above or to an Affiliate; or (d) the sale or transfer
to a Third Party of all or substantially all of such Party’s consolidated assets
taken as a whole.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.10.

“CIS” means Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova,
Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan.

1.11.

“City Code” means the City Code on Takeovers and Mergers as promulgated from
time to time by the London Panel on Takeovers and Mergers.

1.12.

“Clinical Study” means a Phase 1 Study, Phase 2 Study, Pivotal Clinical Study or
Post-Approval Study, as applicable.

1.13.

“Collaboration” means the collaboration of the Parties in the Development,
Manufacture and Commercialization of Collaboration Compounds and Licensed
Products under this Agreement.

1.14.

“Collaboration Compound” means each Benzoxazole Collaboration Compound and each
Next Generation Collaboration Compound.

1.15.

“Collaboration Know-How” means any Know-How or interest therein that is
invented, developed or generated on or after the Effective Date jointly by or on
behalf of (a) Sarepta or its Related Parties or Third Parties on behalf of or
pursuant to contracts with Sarepta or its Related Parties, on the one hand and
(b) Summit or its Related Parties or Third Parties on behalf of or pursuant to
contracts with Summit or its Related Parties, on the other hand, in the
Development, Manufacture or Commercialization of Collaboration Compounds or
Licensed Products.

1.16.

“Collaboration Patent Rights” means any Patent Rights that Cover the
Collaboration Know-How.

1.17.

“Collaboration Technology” means, collectively, Collaboration Know-How and
Collaboration Patent Rights.

1.18.

“Commercialization” or “Commercialize” means any and all activities directed to
marketing, promoting, distributing, importing, exporting, offering to sell or
selling a product and activities directed to obtaining pricing and reimbursement
approvals, as applicable.

1.19.

“Commercially Reasonable Efforts” means (a) with respect to each Party’s
obligations under this Agreement that relate to a Licensed Product (including
Development, Manufacture or Commercialization obligations), those efforts
reasonably used by an entity in the biotechnology/pharmaceutical industry of
similar resources and expertise as such Party, for such similar entity’s own
products (including internally developed, acquired and in-licensed products) of
similar market potential at a similar stage in development or product life,
taking into account all relevant factors, including (i) issues of safety,
tolerability and efficacy, (ii) product profile, (iii) difficulty in and costs
of developing or manufacturing the Licensed Product, (iv) competitiveness of the
Licensed Product and competitive products (but without considering competitive
products Controlled by the Party to which the efforts obligation applies) in the
marketplace, (v) the extent of market exclusivity, (vi) the patent or other
proprietary position of the Licensed Products, (vii)

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Third Party intellectual property rights, (viii) the regulatory structure
involved and (ix) the potential profitability of the Licensed Products; and (b)
with respect to such Party’s other obligations under this Agreement, the
carrying out of such obligations in a diligent, expeditious and sustained manner
using efforts and resources, including reasonably necessary personnel and
financial resources, that biopharmaceutical companies of comparable size and
resources typically devote to similar tasks under similar circumstances.

1.20.

“Competing Product” means [**].

1.21.

“Confidential Information” means any and all confidential or proprietary
information and data, including Summit Know-How, Sarepta Know-How and
Collaboration Know-How and all other scientific, pre-clinical, clinical,
regulatory, manufacturing, marketing, financial and commercial information or
data, whether communicated in writing or orally or by any other method, that is
provided by one Party to the other Party in connection with this Agreement.
Summit Know-How is the Confidential Information of Summit. Sarepta Know-How is
the Confidential Information of Sarepta. Collaboration Know-How and the terms of
this Agreement are the Confidential Information of both Parties.

1.22.

“Control,” “Controls” or “Controlled by” means, with respect to any Know-How,
Patent Rights or other intellectual property rights, the possession of (whether
by ownership or license, other than pursuant to this Agreement), and the ability
of a Person or its Affiliates to assign, transfer, or grant access to, or to
grant a license or sublicense of, such item or right as provided for herein
without violating the terms of any agreement or other arrangement with any Third
Party existing at the time such Person would be required hereunder to assign,
transfer or grant another Person such access or license or sublicense.
Notwithstanding the foregoing, Know-How, Patent Rights or other intellectual
property rights will not be “Controlled” by a Party under this Agreement by
virtue of such Know-How, Patent Rights or other intellectual property rights
being owned or in-licensed by a Third Party at the time that such Third Party
becomes an Affiliate of such Party after the Effective Date as a result of such
Party being acquired by such Third Party (whether by merger, stock purchase or
purchase of assets).

1.23.

“Cost of Goods” means, with respect to API Bulk Drug Substance, Finished Drug
Product or placebo, as the case may be, Manufactured under this Agreement, the
reasonable internal and external costs of a Party or any of its Related Parties
incurred in Manufacturing such API Bulk Drug Substance, Finished Drug Product or
placebo, including: (a) to the extent that such API Bulk Drug Substance,
Finished Drug Product or placebo is Manufactured by a Party or any of its
Related Parties, direct material (including shipping) and direct labor costs,
plus a reasonable allocation of Manufacturing plant overhead (including start-up
costs and depreciation) and a reasonable allocation of the costs of failed
batches, to be further described in the Supply Agreement, but excluding
corporate and administrative overhead and costs associated with excess capacity,
all determined in accordance with the books and records of the applicable Party
or its Related Party(ies) maintained in accordance with GAAP, consistently
applied and (b) to the extent that such API Bulk Drug Substance, Finished Drug
Product or placebo is Manufactured by a Third Party manufacturer, the actual
fees paid by a Party or any of its Related Parties to the Third Party for the

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Manufacture, supply, packaging, labeling and shipping of such API Bulk Drug
Substance, Finished Drug Product or placebo, and any reasonable Out-of-Pocket
Costs and direct labor costs actually incurred by such Party or any of its
Related Parties in managing or overseeing the Third Party relationship, all
determined in accordance with the books and records of the applicable Party or
its Related Party(ies) maintained in accordance with GAAP, consistently applied.

1.24.

“Cover,” “Covering” or “Covers” means, as to a Licensed Product and Patent
Rights, that, in the absence of a license granted under, or ownership of, such
Patent Rights, the manufacture, use, offer for sale, sale or importation of such
Licensed Product would infringe such Patent Rights assuming the validity and
enforceability thereof or, as to a pending claim included in such Patent Rights,
the manufacture, use, offer for sale, sale or importation of such Licensed
Product would infringe such Patent Rights if such pending claim were to issue in
an issued patent.

1.25.

“CPI” shall mean the Consumer Price Index – Urban Wage Earners and Clerical
Workers, U.S. City Average, All Items, 1982-84 = 100, published by the United
States Department of Labor, Bureau of Labor Statistics (or its successor
equivalent index) in the United States.

1.26.

“Development,” “Developing” or “Develop” means, with respect to a Collaboration
Compound or Licensed Product, all activities relating to the discovery,
evaluation, research and preclinical, non-clinical and clinical development of
such Collaboration Compound or Licensed Product prior to or after receiving
Regulatory Approval, and all regulatory activities in support of obtaining
Regulatory Approval other than activities directed to obtaining pricing and
reimbursement approvals.

1.27.

“Development Candidate” means any Next Generation Collaboration Compound that is
designated by the JSC as a Development Candidate in accordance with Section
2.3.1, or included in the Collaboration, following Sarepta’s exercise of a
Declined NG Candidate Option in accordance with Section 2.3.3(c).

1.28.

“Development Costs” means the Out-of-Pocket Costs and FTE Costs (or such other
measure of costs as may be specified in the Development Plan) incurred by either
Party or any of its Related Parties in Developing Collaboration Compounds and
Licensed Products in conducting activities contemplated by the then-current
Development Plan (including any such costs incurred in connection with preparing
and submitting any IND to applicable Regulatory Authorities), in accordance with
this Agreement and determined from the books and records of such Party and its
Affiliates maintained in accordance with GAAP; provided that such activities and
costs are consistent with the then-current Development Plan and budget contained
therein. Development Costs exclude all Third Party License Payments and all
payments due under Summit’s existing grant agreements with the Muscular
Dystrophy Association, Inc. and the Duchenne Partner’s Fund. Notwithstanding the
foregoing, Development Costs will not include any costs incurred in connection
with regulatory activities in support of obtaining any Regulatory Approval for
any Collaboration Compound or Licensed Product, including the cost of preparing
and submitting any NDA with respect to a Collaboration Compound or Licensed
Product or interacting with Regulatory Authorities, which costs shall be borne
by the Parties as set forth in Section 3.3.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.29.

“Development Plan” means the written work plan, timetable and budget for the
Parties’ Licensed Product Development efforts, as approved by the JSC and
amended from time to time in accordance with this Agreement.  

1.30.

“DMD” means Duchenne Muscular Dystrophy.

1.31.

“EMA” means the European Medicines Agency and any successor governmental
authority having substantially the same function.

1.32.

“EU” means the European Union, as its membership may be altered from time to
time, and any successor thereto; provided, however, that, for purposes of this
Agreement, the United Kingdom shall be considered a part of the EU irrespective
of its membership status.

1.33.

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the
rules and regulations of the SEC promulgated thereunder.

1.34.

“Existing Summit In-Licenses” means the agreement set forth on Schedule 1.34.

1.35.

“FDA” means the United States Food and Drug Administration and any successor
governmental authority having substantially the same function.

1.36.

“FDCA” means the United States Federal Food, Drug, and Cosmetic Act of 1938, as
amended from time to time, and the regulations and guidelines promulgated
thereunder.

1.37.

“Field” means all therapeutic and commercial applications of utrophin modulators
in humans for any indication, particularly (but without limitation) for therapy
of the dystrophinopathies DMD and BMD.

1.38.

“Finished Drug Product” means the finished product formulation of a Licensed
Product, containing API Bulk Drug Substance, filled into unit packages for final
labeling and packaging, and as finally labeled and packaged in a form ready for
administration.

1.39.

“First Commercial Sale” means, with respect to a Licensed Product in a country,
the first sale for end use or consumption of such Licensed Product in such
country after all Regulatory Approvals legally required for such sale have been
granted by the Regulatory Authority of such country.

1.40.

“FTE” means [**] hours per year of work devoted to or in support of the
Development or Manufacture of a Licensed Product that is carried out by one or
more qualified scientific, technical or operational management employees of a
Party or its Affiliates.

1.41.

“FTE Cost” means, for any period, the FTE Rate multiplied by the number of FTEs
in such period.

1.42.

“FTE Rate” means [**] per year per FTE, increased annually beginning on January
1, 2017 and thereafter on January 1 of each succeeding year by the percentage
increase in the CPI as of December 31 of the then most recently ended calendar
year over the level of the CPI on December 31, 2015.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.43.

“GAAP” means United States Generally Accepted Accounting Principles (GAAP), or
International Financial Reporting Standards (IFRS) if required in lieu of GAAP
for a public company filing financial reports with the U.S. Securities and
Exchange Commission, in each case, as then current at the relevant time and as
consistently applied by the applicable Party and its Affiliates.

1.44.

“Generic Competition” means, with respect to a Licensed Product in any country
in the Sarepta Territory in a given Calendar Quarter, that, during such Calendar
Quarter, (a) one or more Generic Products are commercially available in such
country and (b) such Generic Products achieve [**] or more of the unit-based
aggregate market share in such country of the Licensed Product and such Generic
Product during such Calendar Quarter as determined by IMS Health data (or data
from an alternative data source that the Parties mutually agree to use).

1.45.

“Generic Product” for a given country means a pharmaceutical product that (a) is
sold by a Person that is not a Related Party of Sarepta and that has not been
granted authorization by Sarepta or any of its Related Parties to make such
sales, (b) contains the same active ingredient(s) as are contained in a Licensed
Product and (c) is approved by the Regulatory Authority pursuant to an
abbreviated approval process that relies, in whole or in part, on such
Regulatory Authority’s previous grant of marketing authorization for a Licensed
Product, or on the safety or efficacy data submitted in support of such
marketing authorization.

1.46.

“Governmental Authority” means any applicable government authority, court,
tribunal, arbitrator, agency, department, legislative body, commission or other
instrumentality of (a) any government of any country or territory, (b) any
nation, state, province, county, city or other political subdivision thereof or
(c) any arbitral or supranational body.

1.47.

“ICH” means International Conference on Harmonization.

1.48.

“IMPD” means an Investigational Medicinal Product Dossier.

1.49.

“IND” means an Investigational New Drug application, Clinical Trial Application
or similar application or submission for approval to conduct human clinical
investigations filed with or submitted to a Regulatory Authority in conformance
with the requirements of such Regulatory Authority.

1.50.

“Indication” means any human disease, condition or syndrome, or sign or symptom
of, or associated with, a human disease or condition.

1.51.

“Initiation” means, with respect to a Licensed Product and a Clinical Study, the
first receipt by the first human subject in such Clinical Study of his or her
first dosing with such Licensed Product in such Clinical Study.

1.52.

“In-Licenses” means, collectively, the Summit In-Licenses and the Sarepta
In-Licenses.

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.53.

“Joint Steering Committee” or “JSC” means the joint steering committee as more
fully described in Section 5.1.

1.54.

“Know-How” means all chemical or biological materials and other tangible
materials, inventions, improvements, practices, discoveries, developments, data,
information, technology, methods, protocols, formulas, knowledge, know-how,
trade secrets, processes, assays, skills, experience, techniques and results of
experimentation and testing, including pharmacological, toxicological and
pre-clinical and clinical data and analytical and quality control data;
provided, however, excluding in any event any Patent Rights.

1.55.

“Laws” means all applicable laws, statutes, rules, regulations, orders,
judgments, injunctions, ordinances or other pronouncements having the binding
effect of law of any Governmental Authority.

1.56.

“Licensed Product” means (a) each Benzoxazole Licensed Product and (b) each Next
Generation Product.

1.57.

“Major European Country” means [**].

1.58.

“Major Option Country” means [**].

1.59.

“Manufacturing” or “Manufacture” means, as applicable, all activities associated
with the production, manufacture, process of formulating, processing, filling,
finishing, packaging, labeling, shipping, importing and storage of Licensed
Products (including API Bulk Drug Substance, Finished Drug Product and placebo),
including process development, process validation, stability testing,
manufacturing scale-up, pre-clinical, clinical and commercial manufacture and
analytical development, product characterization, quality assurance and quality
control development, testing and release.

1.60.

“NDA” means a New Drug Application, Marketing Authorization Application or
similar application or submission filed with a Regulatory Authority in a country
or group of countries to obtain marketing approval for a biological,
pharmaceutical or other therapeutic or prophylactic product in that country or
in that group of countries.

1.61.

“Net Sales” means the aggregate gross invoiced sales prices from sales of all
units of Licensed Products sold by Sarepta and its Related Parties to
independent Third Parties after deducting, if not previously deducted, from the
amount invoiced:

 

(a)

[**];

 

(b)

[**];

 

(c)

[**];

 

(d)

[**];

 

(e)

[**]; and

- 8 -

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(f)

[**].

Such amounts shall be determined from the books and records of Sarepta or its
Related Parties, maintained in accordance with GAAP.

In the case of any sale or other disposal for value, such as barter or
counter-trade, of a Licensed Product, or part thereof, other than in an arm’s
length transaction exclusively for cash, Net Sales shall be calculated as above
on the value of the non-cash consideration received or, if higher, the fair
market price of the Licensed Product in the country of sale or disposal, as
determined in accordance with GAAP.

Notwithstanding the foregoing,  the following will not be included in Net Sales:
[**].

In the event that a Licensed Product is sold in the form of a combination
product containing one or more active pharmaceutical ingredients in addition to
such Licensed Product, Net Sales of such combination product shall be adjusted
by [**].

1.62.

“Next Generation Collaboration Compound” means any small molecule utrophin
modulator other than a Benzoxazole Collaboration Compound that is identified or
developed (a) prior to or on the Effective Date by Summit or any of its
Affiliates or (b) at any time in the conduct of the Collaboration by or on
behalf of either Party or any of its Affiliates or any of its or their
Sublicensees (for Sarepta) or licensees (for Summit). Each “Next Generation
Collaboration Compound” includes [**].

1.63.

“Next Generation Product” means each product comprising or containing a Next
Generation Collaboration Compound; provided, however, products that contain
different dosages and formulations of a product, but utilize the same specific
Next Generation Collaboration Compound, shall not be considered distinct Next
Generation Products.

1.64.

“Option Data Package” means, with respect to a Declined NG Development
Candidate, the information and materials set forth on Schedule 1.64.

1.65.

“Option Territory” means [**].

1.66.

“Out-of-Pocket Costs” means, with respect to certain activities hereunder,
direct expenses paid or payable by either Party or its Affiliates to Third
Parties and specifically identifiable and incurred to conduct such activities
for a Collaboration Compound or Licensed Product, including payments to contract
personnel.

1.67.

“Party” means Sarepta or Summit.

1.68.

“Patent Rights” means (a) all issued patents (including extensions, restorations
by existing or future extension or registration mechanism, including patent term
adjustments, patent term extension, supplemental protection certificates or the
equivalent thereof, substitutions, confirmations, re-registrations,
re-examinations, and patents of addition), (b) patent applications (including
all provisional applications, substitutions, requests for continuation,
continuations, continuations-in-part, divisionals and renewals), (c) inventor’s
certificates and (d) and all equivalents of the foregoing in any country of the
world.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.69.

“Person” shall mean any natural person, corporation, unincorporated
organization, partnership, association, sole proprietorship joint stock company,
joint venture, limited liability company, trust or government, or any agency or
political subdivision of any government, or any other similar entity.

1.70.

“Phase 1 Study” means a study in humans which provides for the introduction into
humans of a product, conducted in healthy volunteers or patients, to obtain
initial information on product safety, tolerability, pharmacological activity or
pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the
equivalent thereof outside the United States).

1.71.

“Phase 2 Study” means a study in humans of the safety, dose ranging or efficacy
of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent
thereof outside the United States).

1.72.

“Pivotal Clinical Study” means any human clinical study of a product that, if
pre-specified primary endpoints are met, would demonstrate the safety and
efficacy of such product as required to support the Regulatory Approval of such
product in an applicable country or territory.

1.73.

“Post-Approval Study” means a non-human or human clinical study of a product
initiated after receipt of Regulatory Approval for such product in a country or
territory.

1.74.

“Product Trademark(s)” means the Trademarks for use in connection with the
distribution, marketing, promotion and sale of the Licensed Product(s). Product
Trademarks specifically excludes the corporate names and logos of the Parties
and their Affiliates. Product Trademarks include both the Summit Trademarks and
the Sarepta Trademarks.

1.75.

“Regulatory Approval” means any and all approvals, licenses, registrations or
authorizations of any Regulatory Authority that are necessary for the marketing
and sale of a product in a country or group of countries (including all pricing
and reimbursement approvals, if required for sale of a product in such country
or group of countries).

1.76.

“Regulatory Authority” means any applicable government regulatory authority
involved in granting approvals for the Development, Manufacturing or
Commercialization of Licensed Products, including the FDA and the EMA.

1.77.

“Regulatory Exclusivity” means, with respect to a Licensed Product in a country,
any exclusive marketing right, data protection or other exclusive right, other
than a Patent Right, conferred by any Regulatory Authority with respect to such
Licensed Product in such country, including new drug exclusivity, new indication
or use exclusivity, pediatric exclusivity or orphan drug exclusivity.

1.78.

“Related Party” means a Party’s Affiliates, permitted Sublicensees and, with
respect to Summit in the Summit Territory, licensees, but, with respect to
Sarepta, excluding Third Party Distributors.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.79.

“Royalty Term” means, on a Licensed Product-by-Licensed Product and
country-by-country basis, the period commencing with the First Commercial Sale
of such Licensed Product in such country and continuing until [**].

1.80.

“Sarepta In-License” means any agreement entered into between Sarepta or its
Affiliates and one or more Third Parties pursuant to which Sarepta or such
Affiliate Controls Patent Rights or Know-How that are reasonably necessary or
useful for Summit to Develop, Manufacture or Commercialize Collaboration
Compounds or Licensed Products in the Field in the Summit Territory.

1.81.

“Sarepta Know-How” means Know-How, other than Collaboration Know-How, that is
Controlled by Sarepta or its Affiliates during the Term and is reasonably
necessary or useful for Summit to Develop, Commercialize or Manufacture
Collaboration Compounds or Licensed Products in the Field in the Summit
Territory.

1.82.

“Sarepta Patent Rights” means those Patent Rights, other than Collaboration
Patent Rights, that are Controlled by Sarepta or its Affiliates during the Term
and are reasonably necessary or useful to Develop, Commercialize or Manufacture
Collaboration Compounds or Licensed Products in the Field in the Summit
Territory.

1.83.

“Sarepta Technology” means, collectively, Sarepta Know-How, Sarepta Patent
Rights and Sarepta’s interest in the Collaboration Technology.

1.84.

“Sarepta Territory” means (a) the EU, the CIS, Switzerland, Norway, Iceland and
Turkey and (b) if Sarepta exercises the Territory Expansion Option pursuant to
Section 4.2, the Option Territory.

1.85.

“Serious Adverse Event” means any adverse event that (a) results in death, (b)
is life threatening, (c) requires inpatient hospitalization or prolongation of
existing hospitalization, (d) results in persistent or significant disability or
incapacity, (e) is a congenital anomaly or birth defect or (f) based upon
appropriate medical judgment is considered an important medical event that may
jeopardize the patient or subject and may require medical or surgical
intervention to prevent one or more outcomes listed in this definition.

1.86.

“Sublicensee” means a Third Party to whom a Party grants a sublicense under any
Summit Technology or Sarepta Technology, as the case may be, to Develop,
Manufacture or Commercialize a Licensed Product in the Field pursuant to Section
7.1.2 or Section 7.2.2 (as applicable).

1.87.

“Summit In-License” means (a) each Existing Summit In-License and (b) any
agreement entered into on or following the Effective Date between Summit or its
Affiliates and one or more Third Parties pursuant to which Summit or such
Affiliate Controls Patent Rights or Know-How that are reasonably necessary or
useful for Sarepta to Develop, Manufacture or Commercialize Collaboration
Compounds or Licensed Products in the Field in the Sarepta Territory.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.88.

“Summit Know-How” means Know-How, other than Collaboration Know-How, that is
Controlled by Summit or its Affiliates during the Term that is reasonably
necessary or useful for Sarepta to Develop, Manufacture or Commercialize
Collaboration Compounds or Licensed Products in the Field in the Sarepta
Territory.

1.89.

“Summit Patent Rights” means those Patent Rights, other than Collaboration
Patent Rights, that are Controlled by Summit or its Affiliates during the Term
that are reasonably necessary or useful to Develop, Manufacture or Commercialize
Collaboration Compounds or Licensed Products in the Field in the Sarepta
Territory, including the Patent Rights identified on Schedule 1.89.

1.90.

“Summit Technology” means, collectively, Summit Know-How, Summit Patent Rights
and Summit’s interest in the Collaboration Technology.

1.91.

“Summit Territory” means all countries and territories of the world other than
the Sarepta Territory.

1.92.

“Territory” means (a) with respect to Summit, the Summit Territory and (b) with
respect to Sarepta, the Sarepta Territory.

1.93.

“Third Party” means an entity other than a Party and its Affiliates.

1.94.

“Third Party Distributor” means any Third Party appointed by Sarepta or any of
its Related Parties to distribute, market and sell any Licensed Product, with or
without packaging rights, in one or more countries in the Sarepta Territory, in
circumstances where such Third Party purchases its requirements of Licensed
Product from Sarepta or its Related Parties for resale but does not (a) make any
royalty or profit share payment to Sarepta or its Related Parties with respect
to its resale of such Licensed Product or (b) assume primary responsibility for
advertising, promotion and sales force activities for such Licensed Product in
such countries.

1.95.

“Third Party License Payment” means royalties, upfront fees, milestones or other
amounts payable under an In-License, excluding sponsored research funding
payments made to Third Parties for Development activities included in the
Development Plan.

1.96.

“Trademark” means any trademark, trade name, service mark, service name, brand,
domain name, trade dress, logo, slogan or other indicia of origin or ownership,
including the goodwill and activities associated with each of the foregoing.

1.97.

“United States” or “U.S.” means the United States of America and its
territories, possessions and commonwealths.

1.98.

“University of Oxford Option Agreement” means the agreement dated November 22,
2013 entered into by and between Summit Corporation PLC, the Chancellor, Masters
and Scholars of the University of Oxford (“Oxford”) and Isis Innovation Limited
(“Isis”), as amended by the Variation Agreement dated November 16, 2015.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

1.99.

“Valid Claim” means a claim of: (a) an issued and unexpired patent, which claim
has not lapsed or been dedicated to the public, withdrawn, cancelled, abandoned,
disclaimed, revoked or held unpatentable, unenforceable or invalid by an
unappealable decision of a court or other governmental agency of competent
jurisdiction, or has not been appealed within the time allowed for appeal, or by
an appealed decision of a court or other governmental agency of competent
jurisdiction where the appeal has been pending for more than two (2) years
(unless and until such decision is subsequently overturned on appeal) and which
has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through reissue, re-examination or disclaimer or otherwise or (b)
a patent application that has been pending less than [**] from the date of
filing of the earliest patent application from which such patent application
claims priority, which claim has not been cancelled, withdrawn or abandoned or
finally rejected by an administrative agency action from which no appeal can be
taken.

1.100.

Additional Definitions.  Each of the following definitions is set forth in the
section of this Agreement indicated below:

DEFINITION:

SECTION:

Acquiring Party

7.7.1

Additional Study

2.2.3(c)

Agreement

Preamble

Back-Up Source

6.4

Bankrupt Party

7.4

Bankruptcy Code

7.4

Bulk Drug Product

Schedule 6.2

cGMP

6.1

CEO

14.1

Clinical Supply Agreement

6.2

Collaboration Manager

5.2

Commercial Supply Agreement

6.2

Competitive Infringement

12.3.1

Contracting Party

5.5

Declined NG Candidate Option

2.3.3(a)

Declined NG Candidate Development Costs

2.3.3(d)(ii)

Declined NG Development Candidate

2.3.1

Defense Action

12.3.1

Development Buy-In

2.2.3(d)

Effective Date

Preamble

Global Branding Strategy

4.4.1

Indemnitee

11.4

Isis

1.98

Losses

11.1

Manufacturing Arbitration Draft

6.3.1

Neutral Expert

6.3.2

Non-Bankrupt Party

7.4

Non-Proposing Party

2.2.3(c)

Opt-In Study

2.3.3(b)

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

DEFINITION:

SECTION:

Option Commencement Notice

2.3.3(b)

Option Exercise Notice

2.3.3(c)

Option Period

2.3.3(c)

Oxford

1.98

Pharmacovigilance Agreement

3.4

Post-Development Buy-In

2.2.3(e)

Promotional Materials

4.4.2

Proposing Party

2.2.3(c)

Safety Termination

13.2.3

Sarepta

Preamble

Sarepta Indemnitees

11.2

Sarepta Territory Commercialization Plan

4.3.1

Sarepta Trademarks

12.8.2

Second Source

6.4

SPC

12.3.4

Standstill Parties

14.1

Standstill Period

14.1

Summit

Preamble

Summit Indemnitees

11.1

Summit Trademarks

12.8.2

Supply Agreement

6.2

Technology Transfer

6.5

Territory Expansion Option

4.2

Territory Expansion Option Exercise Date

4.2

Territory Expansion Option Fee

4.2

Term

13.1

Terminated Countries

13.3.2

Terminated Licensed Product

13.3.1

Third Party Collaboration Agreement

5.5

Third Party Partner

5.5

2.

DEVELOPMENT COLLABORATION

2.1.

Overview.  Prior to the Effective Date, Summit has been engaged in the
Development of Licensed Products. Under this Agreement, the Parties will
collaborate in the further Development of Licensed Products in accordance with
the Development Plan.

2.2.

Development Plan; Amendments; Development Costs.

 

2.2.1.

Development Plan.  The Development of Collaboration Compounds and Licensed
Products shall be governed by the Development Plan, and the Parties may not
Develop any Collaboration Compound or Licensed Product other than in accordance
with the Development Plan or as set forth in Section 2.2.3(c) or Section 2.3.
Each Party shall use Commercially Reasonable Efforts to conduct all their
Development activities relating to Licensed Products in accordance with the
Development Plan. Summit shall prepare the initial draft of the initial

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

Development Plan for review and approval by the JSC. The JSC shall be
responsible for approving the initial Development Plan. Unless otherwise
approved by the JSC, the Development Plan shall include in reasonable detail (a)
all Development activities reasonably anticipated to be undertaken by each
Party, (b) the endpoints for all Clinical Studies contemplated by such plan, (c)
which Clinical Study is intended to be a Pivotal Clinical Study, (d) all
regulatory activities and interactions anticipated to be conducted by each Party
in support of Regulatory Approval of each Licensed Product, including all
planned regulatory filings to be submitted in connection with such approvals,
(e) a good faith non-binding estimate of the dates on which the Parties expect
to achieve each milestone event set forth in TABLE 8.2.1, and, if applicable,
TABLE 8.2.2 and TABLE 8.2.3 and (f) a budget for all Development Costs. The JSC
shall approve the initial Development Plan within ninety (90) days after the
Effective Date in accordance with Section 5.3.1(a), and once the JSC approves
such initial Development Plan, it will be attached to this Agreement as Exhibit
A.

 

2.2.2.

Amendments.  Following the JSC’s approval of the initial Development Plan, it
shall review the Development Plan not less frequently than annually and shall
develop detailed and specific Development Plan updates, each of which shall
update and include annual Development budgets for the following Calendar Year
until the completion of Licensed Product Development activities.  The Parties
may also develop and submit to the JSC from time to time other proposed
substantive amendments to the Development Plan. In addition, upon approval of
any Additional Study by the JSC pursuant to Section 5.3.1(d) and the
Non-Proposing Party’s agreement to co-fund such study, the JSC will amend the
Development Plan to include such Additional Study. Further, upon designation of
such Next Generation Collaboration Compound as a Development Candidate pursuant
to Section 5.3.1(i), the Parties will develop and submit to the JSC an amendment
to the Development Plan that includes the proposed Development activities with
respect to such Next Generation Collaboration Compound. The JSC shall review
such proposed amendments and may approve such proposed amendments or any other
proposed amendments that the JSC may consider from time to time in its
discretion and, upon such approval by the JSC, the Development Plan shall be
amended accordingly. Amendments and updates to the Development Plan, including
any budgets contained in the Development Plan, shall not be effective without
the approval of the JSC.

 

2.2.3.

Development Costs.

 

(a)

Responsibility for Costs.  

 

(i)

During the period beginning on the Effective Date and ending on December 31,
2017, subject to Section 2.2.3(a)(iii), Summit shall be solely responsible for
all Development Costs; provided, however, that, if Sarepta incurs Development
Costs in excess of one hundred ten percent (110%) of the Development Costs
budgeted for activities assigned to Sarepta in the budget of the

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

then-current version of the Development Plan, then Sarepta shall be solely
responsible for such excess costs unless Summit agrees in writing to assume
them.

 

(ii)

Beginning on January 1, 2018, subject to Section 2.2.3(a)(iii) and Section
2.2.3(c), Summit shall pay fifty-five percent (55%) and Sarepta shall pay
forty-five percent (45%) of all Development Costs that are within one hundred
ten percent (110%) of the Development Costs budgeted for activities included in
the budget of the then-current version of the Development Plan.  Any Development
Costs in excess of one hundred ten percent (110%) of such budgeted Development
Costs shall be borne solely by the Party incurring such costs unless such Party
has received the other Party’s written approval to share such excess costs.  

 

(iii)

If Sarepta exercises the Territory Expansion Option pursuant to Section 4.2,
then, from and after the Territory Expansion Option Exercise Date, Sarepta shall
be solely responsible for all Development Costs specifically related to the
Option Territory;  provided, however, that, if Summit incurs Development Costs
specifically related to the Option Territory in excess of one hundred ten
percent (110%) of the Development Costs budgeted for activities assigned to
Summit in the budget of the then-current version of the Development Plan, then
Summit shall be solely responsible for such excess costs unless Sarepta agrees
in writing to assume them.

 

(iv)

In each case contemplated by Sections 2.2.3(a)(i) – 2.2.3(a)(iii), Development
Costs shall initially be borne by the Party incurring the cost or expense,
subject to reimbursement as provided in Section 2.2.3(b).  Each Party shall
calculate and maintain records of Development Costs incurred by it in accordance
with procedures to be established by the JSC pursuant to Section 5.3.1(e).

 

(b)

Development Cost Reports. Within fifteen (15) business days following the
beginning of the last month of each Calendar Quarter, each Party shall prepare
and deliver to the JSC a quarterly report detailing its and its Affiliates’
Development Costs (i) incurred during the first two (2) months of such Calendar
Quarter, (ii) estimated to be incurred during the last month of such Calendar
Quarter and (iii) actually incurred in the last month of the immediately
preceding Calendar Quarter, in each case, ((i)-(iii)), that are required to be
shared pursuant to this Section 2.2.3.  Each Party shall submit any supporting
information or clarifications reasonably requested by the other Party related to
such Development Costs included in such Party’s report within ten (10) business
days after the other Party’s receipt of such request.  The Parties, with the
assistance

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

of the JSC, shall conduct a reconciliation of Development Costs for the subject
Calendar Quarter within ten (10) business days after receipt of all such
supporting information, and an invoice shall be issued to the Party (if any)
that has not paid for its full share of the Development Costs for such Calendar
Quarter.  Such reconciliation shall balance the actual amount of Development
Costs incurred during the last month of the immediately preceding Calendar
Quarter (to correct for any differences between the estimates and actual amount
of such costs) together with the amounts incurred during the first two (2)
months of such Calendar Quarter and those estimated to be incurred during the
last month of such Calendar Quarter.  The paying Party shall pay all amounts
payable under any such invoice within forty-five (45) days after its receipt of
such invoice.

 

(c)

Additional Studies.  If, during the Term, a Party (the “Proposing Party”) wishes
to (i) conduct a Clinical Study or non-clinical study of a Licensed Product that
is not (x) contemplated by the initial Development Plan or (y) included in any
subsequent version of the Development Plan approved by the JSC or (ii) repeat
any Clinical Study or non-clinical study previously conducted under the
Development Plan that failed to meet its primary endpoints (each such study in
clauses (i) and (ii), an “Additional Study”), then (A) the Proposing Party shall
first provide the proposed trial design and protocol for such Additional Study
to the other Party (the “Non-Proposing Party”) for review and comment and shall
incorporate reasonable comments from the Non-Proposing Party into such
Additional Study design and protocol and (B) following such review by the
Non-Proposing Party, provide the final proposed design and projected costs of
such Additional Study to the JSC for review and approval pursuant to Section
5.3.1(d).  The JSC shall approve such Additional Study unless it determines that
such Additional Study would be likely to have a material adverse effect on the
Development or Commercialization of Licensed Products in the Non-Proposing
Party’s Territory. After the JSC’s review of the Additional Study, the following
shall apply:

 

(i)

JSC Approval of Additional Studies. Co-Funding. If the JSC approves the
Additional Study pursuant to Section 5.3.1(d) and the Non-Proposing Party agrees
to co-fund such Additional Study, then the Parties shall amend the Development
Plan to include such Additional Study in accordance with Section 2.2.2, and the
costs of such Additional Study shall be included in the Development Cost shared
by the Parties in accordance with Section 2.2.3.

 

(ii)

JSC Approval of Additional Studies. No Co-Funding. If the JSC approves the
Additional Study pursuant to Section 5.3.1(d), but the Non-Proposing Party does
not wish to include costs incurred

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

with respect to such proposed Additional Study within the shared Development
Cost, then the Proposing Party may proceed with such Additional Study and shall
be solely responsible for the conduct and costs of such study.  In such case,
the Non-Proposing Party would have no rights to use any resulting data in any
filings with any Regulatory Authority in the Non-Proposing Party’s Territory and
would not be granted a right of reference under Section 3.2 with respect to any
resulting data, except, in each case, with respect to safety information
required to be filed with the applicable Regulatory Authorities, unless and
until a Development Buy-In occurs as set forth in Section 2.2.3(d) or a
Post-Development Buy-In occurs as set forth in Section 2.2.3(e).

 

(iii)

Additional Studies Not Approved. If the JSC does not approve the Additional
Study pursuant to Section 5.3.1(d), then the Proposing Party shall not proceed
with such Additional Study.

 

(d)

Development Buy-In. At any time prior to the completion of an Additional Study
that the Non-Proposing Party declined previously to co-fund, the Non-Proposing
Party will have the right to elect by written notice to the Proposing Party to
include in the shared Development Costs the costs of such Additional Study (the
“Development Buy-In”).  In such case, (i) the Parties shall share any
Development Costs from the day of such notice onward incurred by the Proposing
Party to conduct such Additional Study after the Development Buy-In in
accordance with Section 2.2.3 and (ii) the Non-Proposing Party shall reimburse
the Proposing Party an amount equal to [**] of the costs incurred by the
Proposing Party in conducting such Additional Study prior to the day of such
notice. Upon any such Development Buy-In, the Parties shall have the rights with
respect to such Clinical Studies or studies and the data arising therefrom as
set forth in Sections 2.5.3 and 3.2.  If the Non-Proposing Party elects a
Development Buy-In, then it shall pay to the Proposing Party the amount set
forth in the foregoing clause (ii) within forty-five (45) days after the
Non-Proposing Party notifies the Proposing Party in writing that the
Non-Proposing Party is exercising its right to effect the Development Buy-In
pursuant to this Section 2.2.3(d).

 

(e)

Post-Development Buy-In. If the Non-Proposing Party wishes to exercise a buy-in
with respect to an Additional Study after the completion of such Additional
Study (a “Post-Development Buy-In”), then the Non-Proposing Party shall notify
the Proposing Party thereof in writing and pay to the Proposing Party for such
Additional Study a lump sum payment equal to [**] of the costs that the
Proposing Party incurred in conducting such Additional Study. Upon any such
Post-Development Buy-In, the Parties shall have the rights with respect to such
Clinical Studies or studies and the data arising therefrom as set forth in
Sections 2.5.3 and 3.2.  If the Non-Proposing Party elects a Post-Development

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

Buy-In, then it shall pay to the Proposing Party the amount set forth in this
Section 2.2.3(e) within forty-five (45) days after the Non-Proposing Party
notifies the Proposing Party in writing that the Non-Proposing Party is
exercising its right to effect the Post-Development Buy-In pursuant to this
Section 2.2.3(e).

2.3.

Next Generation Products.  

 

2.3.1.

Next Generation Products.  Except as specifically permitted in this Section
2.3.1, neither Summit nor any of its Affiliates shall, itself or with or through
any Third Party, engage in any IND-enabling toxicology studies or clinical
Development or Commercialization of any Next Generation Collaboration Compound
that has not been designated by the JSC as a Development Candidate, or any Next
Generation Product containing or comprising a Next Generation Collaboration
Compound that is not a Development Candidate. If, during the Term, Summit wishes
to conduct any IND-enabling toxicology studies or clinical Development with
respect to a Next Generation Collaboration Compound, then Summit will propose
such Next Generation Collaboration Compound and the Development activities that
it wishes to conduct for such compound to the JSC, and the JSC shall determine
whether or not to designate such Next Generation Collaboration Compound as a
Development Candidate.  If the JSC determines to designate such Next Generation
Collaboration Compound as a Development Candidate, then (a) thereafter Sarepta
will pay the applicable milestone payment set forth TABLE 8.2.2 as the
milestones therein are achieved and (b) the Parties shall amend the Development
Plan to include such applicable Development activities for such Next Generation
Collaboration Compound in accordance with Section 2.2.2. If the JSC does not
designate such Next Generation Collaboration Compound as a Development Candidate
(a “Declined NG Development Candidate”), then such Declined NG Development
Candidate shall no longer be considered a Next Generation Collaboration Compound
under this Agreement, and, subject to Section 2.3.2 and Section 2.3.3, Summit
and any of its Affiliates shall have the right to engage in further Development,
Manufacturing or Commercialization activities with respect to such Declined NG
Development Candidate, or any product containing such Declined NG Development
Candidate (including through Third Parties), in each case solely for the Summit
Territory.

 

2.3.2.

Declined NG Development Candidate Clinical Limit. Summit shall not, directly or
through an Affiliate or Third Party, concurrently perform Clinical Studies on
more than [**].

 

2.3.3.

Sarepta Option Grant for Declined NG Development Candidates.  

 

(a)

Option Grant. Subject to the terms and conditions of this Agreement, with
respect to each Declined NG Development Candidate, Summit hereby grants to
Sarepta an exclusive option to include such Declined

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

NG Development Candidate as a Collaboration Compound under this Agreement (each,
a “Declined NG Candidate Option”).

 

(b)

Option Data Package. For each Declined NG Development Candidate, following
completion of the first Clinical Study that includes the measurement of a
biomarker or other attribute that would show activity of such Declined NG
Development Candidate (the “Opt-In Study”), Summit shall provide written notice
to Sarepta that includes (i) identification of the applicable Declined NG
Development Candidate to which the applicable Declined NG Candidate Option
applies, (ii) the Option Data Package for such Declined NG Development Candidate
and (iii) an estimate of the Declined NG Candidate Development Costs incurred to
date (an “Option Commencement Notice”).

 

(c)

Option Exercise.  To exercise a Declined NG Candidate Option, Sarepta must give
written notice of exercise of such Declined NG Candidate Option to Summit (an
“Option Exercise Notice”) during the period commencing on the date of Sarepta’s
receipt of the Option Commencement Notice containing the complete Option Data
Package for the applicable Opt-In Study and ending [**] thereafter (each, an
“Option Period”).  

 

(d)

Effects of Option Exercise.

 

(i)

Inclusion as a Development Candidate. If Sarepta provides written notice to
Summit exercising the Declined NG Candidate Option for a Declined NG Development
Candidate in accordance with Section 2.3.3(c), then such Declined NG Development
Candidate shall become a Development Candidate for purposes of this Agreement
(and shall no longer be considered a Declined NG Development Candidate).

 

(ii)

Cost Reimbursement. Following Sarepta’s exercise of a Declined NG Candidate
Option with respect to a Declined NG Development Candidate, Summit shall provide
written notice to Sarepta setting forth (A) Summit’s Development Costs (for
purposes of which definition such Declined NG Development Candidate shall be
considered a Collaboration Compound) incurred prior to the date of Sarepta’s
exercise of such Declined NG Candidate Option (the “Declined NG Candidate
Development Costs”) and (B) wire transfer instructions for payment of the
amounts due to Summit under this Section 2.3.3(d)(ii). Within forty-five (45)
days of Sarepta’s receipt of such written notice, Sarepta shall pay to Summit an
amount equal to [**], in each case, pursuant to the wire transfer instructions
provided by Summit in the applicable notice. [**].

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(e)

Failure to Exercise a Declined NG Candidate Option. If Sarepta either fails to
give the Option Exercise Notice with respect to a Declined NG Development
Candidate on or before the expiration or termination of the Option Period for
such Declined NG Development Candidate or notifies Summit in writing prior to
the expiration of such Option Period that Sarepta does not intend to exercise
the Declined NG Candidate Option for such Declined NG Development Candidate,
then the Declined NG Candidate Option with respect to such Declined NG
Development Candidate will terminate, and Sarepta will have no rights to
Develop, Manufacture or Commercialize such Declined NG Development Candidate and
Summit will have the right to Develop, Manufacture and Commercialize such
Declined NG Development Candidate in the Summit Territory and to grant licenses
to Third Parties to do the same.

2.4.

Diligence.  Each of the Parties shall use Commercially Reasonable Efforts to
execute and to perform, or cause to be performed, the activities assigned to it
in the Development Plan and to cooperate with the other Party in carrying out
the Development Plan, in each case, in a good scientific manner and in
compliance with applicable Law.

2.5.

Records; Reports; Information Sharing.

 

2.5.1.

Development Activities.  Each Party will periodically provide to the JSC, but in
no event less than once each Calendar Quarter, or more frequently as reasonably
requested by the other Party, an update regarding Development activities
conducted by or on behalf of such Party.

 

2.5.2.

Scientific Records.  Each Party will maintain scientific records in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes, which records will fully and properly reflect all work done and
results achieved with respect to Licensed Products by such Party.

 

2.5.3.

Information Exchange and Development Assistance.  Subject to Section 2.2.3(c)
and applicable Laws, during the Term, upon the reasonable request of the other
Party, each Party shall provide to the other Party, without additional
compensation and in a commercially reasonable format, Know-How Controlled by
such Party or its Related Parties that is licensed to the other Party under this
Agreement (i.e., Know-How included in Sarepta Technology for Sarepta and
Know-How included in Summit Technology for Summit), including copies of (a) all
scientific information and data related to the Licensed Products (including all
data made, collected or otherwise generated in the conduct of any pre-clinical
studies, Clinical Studies or early access/named patient programs for the
Licensed Products, as well as CMC information) and (b) protocols and
investigator brochures, in each case, that are reasonably necessary for the
other Party (or its Related Parties) to perform its obligations or exploit its
rights under this Agreement with respect to Licensed Products.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

2.5.4.

Personnel.  Each Party may request, through the JSC or the other Party’s
Collaboration Manager, if the JSC appoints Collaboration Managers, that the
other Party reasonably make available for consultation regarding the Development
of Licensed Products certain of its employees engaged in Development activities
with respect to Licensed Products. The JSC or the Collaboration Managers will
reasonably coordinate, upon reasonable notice during normal business hours and
at their respective places of employment, consultation between the Parties on
the progress of Development of Licensed Products under the Development Plan.

 

2.5.5.

Confidentiality.  All information exchanged by the Parties under this Section
2.5 will be Confidential Information of the disclosing Party and will be
maintained in accordance with Section 9.

2.6.

Third Parties.  The Parties shall be entitled to utilize the services of Third
Party contract research and contract manufacturing organizations to perform
their respective Development and Commercialization activities under this
Agreement; provided that (a) each Party shall require that such Third Party
operates in a manner consistent with the terms of this Agreement, (b) each Party
shall remain at all times fully liable for its respective responsibilities and
(c) each Party shall require that any such Third Party be bound by
confidentiality and non-use provisions that are no less stringent than the
provisions of Section 9.

3.

REGULATORY MATTERS.

3.1.

Regulatory Filings and Interactions.  Each Party shall use Commercially
Reasonable Efforts to conduct all regulatory activities relating to Licensed
Products in accordance with the then-current Development Plan. Except as
otherwise provided in the Development Plan, (a) each Party will own the INDs,
the NDAs and related regulatory documents submitted to the applicable Regulatory
Authorities in its Territory with respect to Licensed Products and (b) each
Party will, as to Licensed Products in its Territory, (i) oversee, monitor and
coordinate all regulatory actions, communications and filings with, and
submissions to, each Regulatory Authority, (ii) be responsible for interfacing,
corresponding and meeting with each Regulatory Authority, (iii) be responsible
for maintaining all regulatory filings and (iv) notify the JSC in writing,
including a brief description in English of the principal issues raised, of all
material communications from Regulatory Authorities within [**], provide the JSC
with a summary translation of such material communications in English as soon as
reasonably possible and provide, if appropriate, a full translation of such
material communications in English as soon as reasonably possible thereafter.
Each Party will provide complete copies of any such original correspondence in
their native language to the other Party upon request. Each Party shall provide
the other Party with reasonable advance notice of all material, substantive
meetings with the Regulatory Authorities in its Territory pertaining to any
Licensed Products, or with as much advance notice as practicable under the
circumstances. Each Party shall use Commercially Reasonable Efforts, to the
extent reasonably practicable, to permit the other Party to have, at the other
Party’s expense, one (1) mutually acceptable representative of the other Party
to attend, solely as an observer, material, substantive

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

meetings with the Regulatory Authorities in the major market countries within
such Party’s Territory pertaining to any Licensed Product. Each Party shall
furnish the other Party with drafts of all copies of such Party’s filings and
submissions for Regulatory Approval (including draft INDs, NDAs, orphan drug
applications and designations) regarding any Licensed Product in such Party’s
Territory in a timely manner in sufficient time prior to making such filings and
submissions to allow the other Party a reasonable opportunity to review and
comment thereon and shall consider the other Party’s timely comments in good
faith. In addition, each Party shall provide the other Party with written notice
of (x) all filings and submissions for Regulatory Approval regarding any
Licensed Product in such Party’s Territory in a timely manner; (y) all
Regulatory Approvals obtained or denied; and (z) [**]; provided, however, that
in all circumstances, each Party shall inform the other Party of such event
prior to public disclosure of such event by such Party.

3.2.

Right of Reference.  Subject to Section 2.2.3(c), each Party hereby grants to
the other Party a “Right of Reference,” as that term is defined in 21 C.F.R. §
314.3(b) (or any successor rule or analogous Law recognized outside of the
United States), to, and a right to copy, access and otherwise use, all
information and data (including all CMC information as well as data made,
collected or otherwise generated in the conduct of any Clinical Studies or early
access/named patient programs for the Licensed Products) included in any
regulatory filing, Regulatory Approval, drug master file or other regulatory
documentation (including orphan drug applications and designations) owned or
controlled by such Party or its Related Parties that relates to any Licensed
Product, and such Party shall provide a signed statement to this effect, if
requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or
any successor rule or analogous Law outside of the United States).

3.3.

Regulatory Costs; Regulatory Diligence.  Each Party will be responsible for all
costs incurred in connection with regulatory activities in support of obtaining
any Regulatory Approval for the Licensed Products in its Territory, including
the cost of preparing and submitting any NDA with respect to a Licensed Product
or interacting with Regulatory Authorities in its Territory (but excluding any
such costs incurred in connection with preparing and submitting any IND to
applicable Regulatory Authorities, which shall be included in Development Costs
and shared by the Parties pursuant to Section 2.2.3). Subject to the Parties’
completion of Development sufficient to support such filings, Sarepta shall use
Commercially Reasonable Efforts to file NDAs for Licensed Products in the [**]
Major European Countries (either directly or through the centralized process
with the EMA, and, if such NDA filed for the EMA does not cover the United
Kingdom, also in the United Kingdom) and, if Sarepta exercises the Territory
Expansion Option, in [**] of the Major Option Countries.

3.4.

Pharmacovigilance.  Within [**] after the Effective Date, or such later time as
may be mutually agreed by the Parties, but in any event prior to the
commencement of any clinical activities by Sarepta in the Sarepta Territory, the
Parties will develop and agree in writing upon a pharmacovigilance agreement
(“Pharmacovigilance Agreement”) that will include safety data exchange
procedures governing the coordination of collection, investigation, reporting
and exchange of information concerning any adverse experiences and any product
quality and product complaints involving adverse experiences, related to
Licensed Products, sufficient to enable each Party (and their respective Related
Parties, if

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

any) to comply with its legal and regulatory obligations.  Unless otherwise
agreed by the Parties, the Pharmacovigilance Agreement will [**]. The
Pharmacovigilance Agreement will contain terms no less stringent than those
required by ICH or other applicable guidelines in order to allow the Parties to
meet the applicable regulatory and legal requirements regarding the management
of safety data in their respective Territories.

4.

COMMERCIALIZATION OF THE LICENSED PRODUCTS

4.1.

Responsibility, Cost and Diligence.

 

4.1.1.

Sarepta. Sarepta shall be solely responsible, at its expense, for all
Commercialization activities relating to Licensed Products in the Field in the
Sarepta Territory. Sarepta shall use Commercially Reasonable Efforts to
Commercialize Licensed Products (a) in each Major European Country, (b) in each
country of the CIS, Switzerland, Norway, Iceland and Turkey and (c) if Sarepta
exercises the Territory Expansion Option, in [**] of the Major Option Countries,
in each case ((a) – (c)), subject to obtaining Regulatory Approval in the
applicable country.

 

4.1.2.

Summit. Summit shall be solely responsible, at its expense, for all
Commercialization activities relating to Licensed Products in the Field in the
Summit Territory.

 

4.1.3.

Joint Commercialization.  In the event that the Parties mutually agree to
conduct any joint Commercialization activities regarding a Licensed Product
following discussion of such activities by the JSC in accordance with Section
5.3.2(e), the Parties will (a) agree in writing to a written work plan and time
table for conducing such activities, (b) agree in writing to management and
governance mechanisms for such joint activities, including coordination of such
activities through the JSC and (c) negotiate in good faith a budget therefor and
an equitable allocation of costs between the Parties.

4.2.

Sarepta’s Territory Expansion Option.  Beginning on the Effective Date, Sarepta
shall have the option to expand the Sarepta Territory to include the Option
Territory (the “Territory Expansion Option”).  At any time prior to the date
that is three (3) months following the first receipt of Regulatory Approval for
a Licensed Product in the United States or in any country in the EU (or from the
EMA), Sarepta may exercise the Territory Expansion Option by notifying Summit
thereof in writing and paying to Summit [**] (the “Territory Expansion Option
Fee”).  From and after the date on which Sarepta exercises the Territory
Expansion Option (the “Territory Expansion Option Exercise Date”), the Sarepta
Territory shall include the Option Territory. Summit shall not grant to any
Third Party any rights with respect to Collaboration Compounds or Licensed
Products in the Option Territory prior to the expiration of the Territory
Expansion Option.

4.3.

Commercialization Plans and Information.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

4.3.1.

Sarepta Commercialization Plan.  No less than [**] months in advance of the
reasonably expected first Regulatory Approval in the Sarepta Territory with
respect to a Licensed Product, and on an annual basis thereafter, Sarepta shall
prepare and deliver to the JSC for review a reasonable written plan that
summarizes the Commercialization activities to be undertaken with respect to
Licensed Products in the Sarepta Territory in the next Calendar Year and, to the
extent commercially reasonable, Sarepta’s plans to Commercialize Licensed
Products in countries in the Sarepta Territory in which Sarepta is not then
Commercializing Licensed Products, and the dates by which such activities are
targeted to be accomplished (the “Sarepta Territory Commercialization Plan”).
The Sarepta Territory Commercialization Plan shall subsequently be updated and
modified by Sarepta, from time to time at its discretion and no less frequently
than once per Calendar Year, based upon, among other things, Sarepta’s
Commercialization activities with respect to Licensed Products in the Sarepta
Territory, a copy of which updated plan Sarepta will provide to the JSC. The
Sarepta Territory Commercialization Plan, and each modification thereto, shall
be consistent with Sarepta’s diligence obligations under Section 4.1.1.

 

4.3.2.

Summit Commercialization Information.  From time to time as may be reasonably
requested by Sarepta’s JSC representatives, Summit shall provide to the JSC
reasonable summaries of Summit’s Commercialization activities with respect to
Licensed Products in the Summit Territory and Summit’s plans to Commercialize
Licensed Products in countries in the Summit Territory, in each case to the
extent such information is reasonably relevant and useful for purposes
of  coordinating the Parties’ Commercialization activities and for Sarepta’s
preparation of the Sarepta Territory Commercialization Plan and amendments
thereto.

4.4.

Advertising and Promotional Materials.

 

4.4.1.

Global Branding. The JSC shall implement (and thereafter modify and update) a
global branding strategy (including global positioning, messages, logo, colors
and other visual branding elements) jointly developed by the Parties for
Licensed Products for use in the Field worldwide (the “Global Branding
Strategy”). The JSC shall review the Global Branding Strategy at least annually
(or more frequently if reasonably requested by either Party) and determine
whether to update or modify it.

 

4.4.2.

Summit.  Summit will be responsible for the creation, preparation, production,
reproduction and filing with the applicable Regulatory Authorities, of relevant
written sales, promotion and advertising materials relating to Licensed Products
(“Promotional Materials”) for use in the Summit Territory. All such Promotional
Material will be (a) compliant with applicable Law and (b) if applicable,
consistent in all material respects with the Global Branding Strategy. Summit
will submit representative samples of its Promotional Materials developed by it
for use in the Summit Territory to the JSC for its review and discussion, at
least annually (or more frequently if reasonably requested by

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

Sarepta). Summit shall consider in good faith any timely comments Sarepta may
have with respect to such Promotional Materials, but shall have final
decision-making authority with respect to such Promotional Materials.

 

4.4.3.

Sarepta.  Sarepta will be responsible for the creation, preparation, production,
reproduction and filing with the applicable Regulatory Authorities, of relevant
Promotional Materials for use in the Sarepta Territory. All such Promotional
Materials will be (a) compliant with applicable Law, (b) consistent in all
material respects with the Sarepta Territory Commercialization Plan and (c) if
applicable, consistent in all material respects with the Global Branding
Strategy. Sarepta will submit representative samples of its Promotional
Materials developed by it for use in the Sarepta Territory to the JSC for its
review and discussion at least annually thereafter (or more frequently if
reasonably requested by Summit). Sarepta shall consider in good faith any timely
comments Summit may have with respect to such Promotional Materials, but shall
have final decision-making authority with respect to such Promotional Materials.

4.5.

Reporting Obligations.  Sarepta shall report to the JSC in writing, by no later
than each February 28 following the first Regulatory Approval of a Licensed
Product in the Field in the Sarepta Territory (for the period ending December 31
of the prior Calendar Year), summarizing Sarepta’s Commercialization activities
and resources expended for Licensed Products performed to date (or updating such
report for activities performed since the last such report was given hereunder,
as applicable). In addition, Sarepta shall provide Summit with written notice of
the First Commercial Sale of each Licensed Product in the Sarepta Territory
within fifteen (15) days after such event; provided, however, that in all
circumstances, Sarepta shall inform Summit of such event prior to public
disclosure of such event by Sarepta. Each Party shall provide such other
information to the JSC as the other Party may reasonably request and shall keep
the JSC reasonably informed of such Party’s Commercialization activities with
respect to Licensed Products.

4.6.

Sales and Distribution. Each Party and its Related Parties shall be responsible
for booking sales and shall warehouse and distribute Licensed Products in its
Territory. If a Party receives any orders for any Licensed Product in the other
Party’s Territory, then it shall refer such orders to the other Party. Moreover,
each Party and its Related Parties shall be solely responsible for handling all
returns of Licensed Product sold in its Territory, as well as all aspects of
Licensed Product order processing, invoicing and collection, distribution,
inventory and receivables of Licensed Products sold in its Territory.

4.7.

Recalls, Market Withdrawals or Corrective Actions.  In the event that any
Regulatory Authority issues or requests a recall or takes a similar action in
connection with the Licensed Products in a Territory, or in the event either
Party determines that an event, incident or circumstance has occurred that may
result in the need for a recall, market withdrawal or stock recovery in its own
Territory, the Party notified of such recall or similar action, or the Party
that desires such recall or similar action, shall within twenty-four (24) hours
and in all cases prior to the execution of such recall, market withdrawal or
stock recovery advise the other Party thereof by telephone, facsimile or e-mail
(except in the case of a government mandated recall, when such Party may not
provide such advance notice

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

but shall notify the other Party as soon as possible). Each Party, in
consultation with the other Party, shall decide whether to conduct a recall in
its own Territory and the manner in which any such recall shall be conducted
(except in the case of a government mandated recall, when such Party may act
without such advance consultation but shall notify the other Party as soon as
possible). Each Party shall be responsible for the execution of any such recall
in its own Territory, and in each such case the other Party shall take such
actions as reasonably requested by the executing Party in connection therewith
and otherwise reasonably cooperate in all such efforts. Except as otherwise
provided in a Supply Agreement, each Party shall bear the expense of any such
recall in its own Territory, provided that Summit shall reimburse Sarepta for
the expense of any such recall in the Sarepta Territory to the extent such
recall is the result of a Manufacturing defect in Licensed Product supplied by
(or on behalf of) Summit to Sarepta.  In addition, each Party will make
available all of its pertinent records that may be reasonably requested by the
other Party in order to effect a recall in the other Party’s Territory.

4.8.

Commercial Expenses.  Except where otherwise specifically set forth in this
Agreement, each Party shall bear all costs and expenses incurred in connection
with its Commercialization of Licensed Products in its Territory.

4.9.

Ex-Territory Sales; Export Monitoring.

 

4.9.1.

Ex-Territory Sales.  Subject to applicable Law, neither Party shall engage in
any advertising or promotional activities relating to any Licensed Product
directed primarily to customers or other buyers or users of such Licensed
Product located outside its Territory or accept orders for Licensed Products
from or sell Licensed Products into such other Party’s Territory for its own
account, and if a Party receives any order for Licensed Products in the other
Party’s Territory, then it shall refer such orders to the other Party.

 

4.9.2.

Export Monitoring.  Each Party and its Related Parties will use Commercially
Reasonable Efforts to monitor and prevent exports of Licensed Products from its
own Territory for Commercialization in the other Party’s Territory using methods
commonly used in the industry for such purpose, and shall promptly inform the
other Party of any such exports of Licensed Products from its Territory, and the
actions taken to prevent such exports. Each Party agrees to take reasonable
actions requested in writing by the other Party that are consistent with Law to
prevent exports of Licensed Products from its Territory for Commercialization in
the other Party’s Territory.

5.

COLLABORATION MANAGEMENT

5.1.

Joint Steering Committee. The Parties hereby establish a joint steering
committee (the “JSC”) to facilitate the Collaboration as follows:

 

5.1.1.

Composition of the Joint Steering Committee.  The Collaboration shall be
conducted under the oversight of the JSC, which shall be comprised of [**]
representatives of each Party. Each Party shall appoint its respective

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

representatives to the JSC and may substitute any of its representatives, in its
sole discretion, effective upon notice to the other Party of such change.
Additional representatives or consultants may from time to time, by mutual
consent of the Parties, be invited to attend JSC meetings, subject to such
representatives and consultants undertaking confidentiality obligations, whether
in a written agreement or by operation of law, no less stringent than the
provisions of Section 9.

 

5.1.2.

JSC Chairperson.  The JSC chairperson shall rotate every [**] between a JSC
representative of Summit and a JSC representative of Sarepta. The initial JSC
chairperson shall be a representative of [**]. The JSC chairperson’s
responsibilities shall include (a) scheduling meetings at least once per
Calendar Quarter, but more frequently if the JSC determines it necessary; (b)
setting agendas for meetings with solicited input from other members; (c)
coordinating the delivery of draft minutes to the JSC for review and final
approval; and (d) conducting meetings, including ensuring that objectives for
each meeting are set and achieved.

5.2.

Appointment of Subcommittees, Project Teams and Collaboration Managers.  The JSC
shall be empowered to create such subcommittees and project teams as it may deem
appropriate or necessary.  Each such subcommittee and project team shall report
to the JSC, which shall have the authority to approve or reject recommendations
or actions proposed thereby subject to the terms of this Agreement. The JSC may
direct each Party to designate a Collaboration manager to serve as a primary
point of contact for the other Party under the Collaboration (the “Collaboration
Manager”). Each Party may change its Collaboration Manager at any time in its
sole discretion with written notice to the other Party.

5.3.

Meetings.  The JSC shall meet in accordance with a schedule established by
mutual written agreement of the Parties, but no less frequently than once per
Calendar Quarter during the Term, with the location for such meetings
alternating between Summit and Sarepta facilities (or such other locations as
are mutually agreed by the Parties). Alternatively, the JSC may meet by means of
teleconference, videoconference or other similar communications equipment, but
at least two (2) meetings per Calendar Year shall be conducted in person. Each
Party shall bear its own expenses relating to attendance at such meetings by its
representatives.

 

5.3.1.

JSC Development Responsibilities.  The JSC shall have the following
responsibilities with respect to the Development of Licensed Products pursuant
to the Collaboration:

 

(a)

Reviewing, approving or declining to approve the initial Development Plan as set
forth in Section 2.2, and preparing, reviewing, approving or declining to
approve proposed amendments to, the Development Plan, in each case, in
accordance with Section 2.2.2;

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(b)

monitoring, planning and coordinating the Development of Licensed Products and
regularly assessing the progress of the Parties in their conduct of the
Development Plan against the timelines and budgets contained therein, reviewing
relevant data;

 

(c)

reviewing updates regarding the Development of Licensed Products provided by the
Parties pursuant to Section 2.5.1 (or otherwise);

 

(d)

approving or declining to approve Additional Studies in accordance with Section
2.2.3(c);

 

(e)

establishing procedures for maintaining and recording Development Costs and, in
accordance with Section 2.2.3(b), assisting the Parties in conducting a
reconciliation of Development Costs in each Calendar Quarter;

 

(f)

reviewing and discussing material communications received from Regulatory
Authorities in accordance with Section 3.1;

 

(g)

assisting the Parties to conduct a reconciliation of Development Costs for the
subject Calendar Quarter within ten (10) days after receipt of all such
supporting information pursuant to Section 2.2.3(b);  

 

(h)

overseeing the manufacturing relationship between the Parties with respect to
the Manufacture and supply of Licensed Products for Development activities
pursuant to Section 6.1 and the Clinical Supply Agreement;

 

(i)

designating or declining to designate Next Generation Collaboration Compounds as
a Development Candidate in accordance with Section 2.3;

 

(j)

serving as a forum for the Parties’ discussions of intellectual property issues,
including potential opportunities identified by the Parties for licensing Third
Party intellectual property; and

 

(k)

performing such other activities as the Parties agree in writing shall be the
responsibility of the JSC.

 

5.3.2.

JSC Commercialization Responsibilities.  The JSC shall have the following
responsibilities with respect to the Commercialization of Licensed Products
pursuant to the Collaboration, to the extent permissible under applicable Laws:

 

(a)

implementing, modifying and updating the Global Branding Strategy pursuant to
Section 4.4.1;

 

(b)

reviewing and discussing the Sarepta Territory Commercialization Plan, including
updates thereto provided by Sarepta pursuant to Section 4.3.1

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

and Summit’s Commercialization information in its Territory provided by Summit
pursuant to Section 4.3.2;

 

(c)

reviewing and discussing Promotional Material for use in each Party’s Territory
in accordance with Sections 4.4.2 and 4.4.3;

 

(d)

providing a forum for the Parties to discuss the Commercialization of Licensed
Products in the Field worldwide, including coordination regarding Licensed
Product positioning and messaging, key opinion leader relationship management,
medical affairs and marketing and selling materials;

 

(e)

providing a forum for the Parties to discuss collaborating on commercial
activities that can be leveraged for both Parties’ respective Territories agreed
to by the Parties in accordance with Section 4.1.3 and how the Parties would
share the costs of such mutually agreed joint Commercialization activities;

 

(f)

overseeing the manufacturing relationship between the Parties with respect to
the Manufacture of Licensed Products for Commercialization activities pursuant
to Section 6.1 and the Commercial Supply Agreement;

 

(g)

reviewing and discussing the Product Trademark(s) proposed for use by Sarepta
and its Related Parties throughout the Sarepta Territory pursuant to Section
12.8.2; and

 

(h)

performing such other activities as the Parties agree in writing shall be the
responsibility of the JSC.

5.4.

Decision-Making.

 

5.4.1.

Voting; Consensus.  With respect to decisions of the JSC, the representatives of
each Party shall have collectively one vote on behalf of such Party. For each
meeting of the JSC, [**]. Action on any matter may be taken at a meeting by
teleconference, videoconference or by written agreement. The JSC shall attempt
to resolve any and all disputes before it for decision by consensus.

 

5.4.2.

Escalation to CEOs.  If the JSC is unable to reach consensus with respect to a
dispute for a period in excess of [**], then the dispute shall be submitted to
the Chief Executive Officers of Summit and Sarepta, or their designees (any such
designee to be a senior member of the designating Chief Executive Officer’s
management team) for resolution.

 

5.4.3.

Tie-Breaking Authority.  If such dispute cannot be resolved for a period in
excess of [**] following escalation, then:

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(a)

Sarepta Matters. Subject to clause (c) below, the Chief Executive Officer of
Sarepta or his or her designee shall have the deciding vote on any matter
involving the Commercialization of Licensed Products in the Field in the Sarepta
Territory;

 

(b)

Summit Matters. Subject to clause (c) below, the Chief Executive Officer of
Summit or his or her designee shall have the deciding vote on any matter
involving [**]; and

 

(c)

Matters Reserved for Consensus.  Neither party shall have the deciding vote on
any of the following matters:

 

(i)

[**];

 

(ii)

[**];

 

(iii)

[**];

 

(iv)

[**];

 

(v)

[**];

 

(vi)

[**];

 

(vii)

[**]; or

 

(viii)

[**].

 

5.4.4.

No Authority to Amend.  Notwithstanding anything to the contrary set forth
herein, the JSC shall not have the authority to modify the terms of this
Agreement or take any action to expand or narrow the responsibilities of the
JSC.

5.5.

Third Party Partners.  If, at any time during the Term, a Party enters into an
agreement with one or more Third Party(ies) (a “Third Party Partner”) (each such
agreement, a “Third Party Collaboration Agreement”, and the Party entering such
Third Party Collaboration Agreement the “Contracting Party”) to Develop or
Commercialize a Licensed Product in the Field in the Contracting Party’s
Territory, then the Contracting Party shall ensure that such agreement is
consistent with the terms and conditions of this Agreement. Without limiting the
foregoing, the Contracting Party shall use reasonable efforts to negotiate terms
in the Third Party Agreement regarding (a) intellectual property rights
necessary to permit the Contracting Party to license or sublicense to the other
Party, in accordance with the terms of this Agreement, any Patent Rights and
Know-How developed in the course of activities pursuant to the Third Party
Collaboration Agreement related to the Licensed Products that are the subject of
this Agreement, if any, and (b) providing the other Party with reciprocal
information, rights of reference and other rights and benefits with respect to
regulatory matters in the Third Party Partner’s Territory as are provided to the
other Party in Section 3.2. The Contracting Party shall promptly provide

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

the other Party with a copy of any fully executed Third Party Collaboration
Agreement, which may be redacted to remove terms and conditions that are not
necessary to monitor compliance with this Section 5.5 and such Third Party
Collaboration Agreement will be the Contracting Party’s Confidential Information
for the purposes of Section 9.  In addition, if the Third Party Collaboration
Agreement grants the Third Party Partner a sublicense under the Sarepta
Technology or Summit Technology, as applicable, then the Contracting Party shall
ensure that such Third Party Collaboration agreement complies with Section 7.1.2
or Section 7.2.2, as applicable. If the Contracting Party becomes aware of a
material breach of the terms of such Third Party Collaboration Agreement by a
Third Party Partner compliance with which is necessary for the Contracting
Party’s compliance with the terms of this Agreement, then the Contracting Party
shall promptly notify the other Party of the particulars of the same and use
Commercially Reasonable Efforts to cause the Third Party Partner to comply with
all the terms of the Third Party Collaboration Agreement necessary for the
Contracting Party’s compliance with the terms of this Agreement. Notwithstanding
any Third Party Collaboration Agreement, the Contracting Party shall remain
primarily liable to the other Party for the performance of the Contracting
Party’s obligations under, and the Contracting Party’s compliance with all terms
and conditions of, this Agreement with respect to the Contracting Party’s
Territory.

6.

MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCT

6.1.

Supply Obligations.  From and after the Effective Date, but subject to a right
of Summit to terminate such supply obligations on [**] prior written notice to
Sarepta, subject to the Supply Agreements once entered into pursuant to Section
6.2, Summit will use Commercially Reasonable Efforts, either itself or through
Third Parties, to Manufacture API Bulk Drug Substance, Finished Drug Product and
placebo meeting all applicable product specifications as filed in the IPMD and
other applicable regulatory filings, in accordance with applicable current Good
Manufacturing Practices and equivalent Laws outside the United States (“cGMP”),
and supply to Sarepta API Bulk Drug Substance, Finished Drug Product and placebo
(as applicable) in quantities that are reasonably sufficient for the conduct of
Development and Commercialization by Sarepta with respect to the Sarepta
Territory under the Development Plan and the Sarepta Territory Commercialization
Plan, respectively.  For any API Bulk Drug Substance or Finished Drug Product
supplied by Summit to Sarepta pursuant to this Section 6.1 for purposes of
Commercialization in the Sarepta Territory, Sarepta shall pay to Summit an
amount equal to [**] of Summit’s Cost of Goods for such API Bulk Drug Substance
or Finished Drug Product (as applicable), payable within forty-five (45) days
after receipt of an invoice therefor.  Except with respect to any Additional
Studies as to which a Non-Proposing Party has not opted in in accordance with
Section 2.2.3(c), [**] of Summit’s Cost of Goods incurred in Manufacturing API
Bulk Drug Substance, Finished Drug Product and placebo for purposes of
Development worldwide shall be Development Costs borne by the Parties in
accordance with Section 2.2.3.  With respect to any Additional Study as to which
the Non-Proposing Party has not opted into in accordance with Section 2.2.3(c),
[**] of Summit’s Cost of Goods incurred in Manufacturing API Bulk Drug
Substance, Finished Drug Product and placebo for purposes of conducting such
Additional Study shall be borne solely by the Proposing Party, and, if such
Party is Sarepta, then Sarepta shall pay such amounts to Summit within [**]
after receipt of an invoice therefor.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

6.2.

Supply Agreements.  Within [**] after the Effective Date, the Parties will
negotiate in good faith and enter into (a) a supply agreement for clinical
supply of Licensed Products and placebo (the “Clinical Supply Agreement”) and a
related quality agreement, if the Development Plan anticipates a need for Summit
to supply Sarepta in order to enable Sarepta to carry out Development activities
allocated to it in the Development Plan and (b) a supply agreement for
commercial supply of Licensed Products (the “Commercial Supply Agreement” and
together with the Clinical Supply Agreement, the “Supply Agreements”) and a
related quality agreement, which Supply Agreements will each be consistent with
the terms set forth in Schedule 6.2 and the terms set forth in Section 6.1 with
respect to clinical supply of Licensed Product. Notwithstanding anything to the
contrary set forth herein, when the Parties enter into the Supply Agreements,
the terms of such Supply Agreements shall supersede the terms set forth in
Section 6.1.

6.3.

Arbitration for Failure to Agree.  If the Parties cannot reach agreement and
enter into any Supply Agreement (or related quality agreement) within the
applicable period set forth in Section 6.2, then the final terms and conditions
of such Supply Agreement (or related quality agreement) will be determined
through binding arbitration as follows:

 

6.3.1.

Manufacturing Arbitration Drafts.  Each Party will (a) prepare a draft of such
Supply Agreement (or related quality agreement) (which will be consistent with
the applicable terms set forth on Schedule 6.2 the terms set forth in Section
6.1 with respect to clinical supply of Licensed Product for Additional Studies)
to be used in such arbitration proceeding (each, a “Manufacturing Arbitration
Draft”) and (b) submit its Manufacturing Arbitration Draft to the other Party.
Within fifteen (15) days of such submissions, the Parties will meet to determine
whether or not they agree to enter into either Party’s Manufacturing Arbitration
Draft or a modified version thereof as such Supply Agreement (or related quality
agreement).

 

6.3.2.

Notice; Experts. If the Parties are unable to agree within the fifteen (15) day
period set forth in Section 6.3.1, then either Party may send the other Party
written notice that it wishes to determine the final terms and conditions of
such Supply Agreement using a Neutral Expert. Within thirty (30) days of a
Party’s receipt of such notice, the Parties shall jointly appoint a neutral
Third Party who is an expert with at least fifteen (15) years of experience in
the area of manufacturing and supply (the “Neutral Expert”) within ten (10)
business days.

 

6.3.3.

Resolution by Arbitration. Within three (3) business days of such meeting, each
Party may submit an opposition statement of no more than five (5) pages in
length to the Neutral Expert. Neither Party will be allowed to conduct any
discovery.  Neither Party may have any communications (either written or oral)
with the Neutral Expert other than for the sole purpose of engaging the Neutral
Expert or as expressly permitted in this Section 6.3.3. The Neutral Expert may
consult in writing with either Party regarding the submissions made by either
Party; provided that both Parties receive such request for consultation and are
provided with an opportunity to respond. In evaluating each Party’s written
submissions, the Neutral Expert shall, within ten (10) business days of receipt

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

of the written opposition statement, select one of the Parties’ Manufacturing
Arbitration Drafts within thirty (30) days following the receipt of the latter
of such Manufacturing Arbitration Drafts and select the draft that it determines
to contain the most fair, balanced and customary terms (in addition to
reflecting the applicable terms set forth on Schedule 6.2 and the applicable
terms set forth in Section 6.1 with respect to clinical supply of Licensed
Product for Additional Studies); provided that, the Neutral Expert shall not
select, and Summit shall not be required to execute or perform under, any Supply
Agreement that would require Summit to undertake obligations that cannot be
satisfied through the use of Commercially Reasonable Efforts.  Such decision
shall be final, binding and conclusive upon both Parties and their Affiliates,
and such Manufacturing Arbitration Draft will be the applicable Supply Agreement
(or related quality agreement), and the Parties will execute the same.

 

6.3.4.

Responsibility for Costs. The fees of the Neutral Expert will be borne by the
Party whose Manufacturing Arbitration Draft is not selected by the arbitral
tribunal.

6.4.

Establishment of Second Source and Back-Up Sources.  If the Parties have entered
into a Supply Agreement, and Sarepta notifies Summit that it desires that a
second source be established for the concurrent Manufacture and supply of a
Licensed Product for clinical or commercial use (a “Second Source”) or that a
back-up supplier be established for the contingent Manufacture and supply of a
Licensed Product for clinical or commercial use (a “Back-Up Source”), then
Summit shall reasonably assist Sarepta in establishing a Second Source or
Back-Up Source on a timeline agreed by the Parties and in accordance with the
terms of this Section 6.4. Notwithstanding the foregoing, Sarepta may not
provide such notification to Summit requesting that a Second Source or Back-Up
Source be established unless and until [**]. A Second Source or Back-Up Source
established by Sarepta may also serve as a Second Source or Back-Up Source for
Summit.  In addition, if Summit desires to establish a Second Source or a
Back-Up Source (as applicable) for a Licensed Product for clinical or commercial
use, then Summit shall notify Sarepta in advance of Summit’s commencement of
material negotiations with one or more Third Party manufacturers relating to the
establishment of a Second Source or Back-Up Source (as applicable) for the
Manufacture and supply of such Licensed Product.

6.5.

Transfer of Manufacturing Know-How. During the Term, upon Sarepta’s request,
Summit shall transfer to Sarepta and to the applicable Second Source and Back-Up
Sources described in Section 6.4 all Summit Know-How then Controlled by Summit
that is reasonably necessary or useful to enable the Manufacture of each
Licensed Product for clinical or commercial use and not previously transferred
to Sarepta under this Agreement by providing copies or samples of relevant
documentation, materials and other embodiments of such Know-How, and by making
available its qualified technical personnel on a reasonable basis to consult
with Sarepta, the Second Source and Back-Up Sources, as applicable, with respect
to such Know-How. Each such Know-How transfer requested by Sarepta for itself,
for the Second Source or for a Sarepta-selected Back-Up Source (“Technology
Transfer”) shall be commenced within a commercially reasonable timeframe
following Sarepta’s request and conducted pursuant to an agreed technology

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

transfer plan to be developed by the Parties (with input from the Second Source
or Back-Up Sources, as applicable) for the purpose of ensuring the complete and
timely transfer of such Know-How in a manner that is consistent with
then-current internal technology transfer corporate standards (or equivalent
policy) of Sarepta or the Second Source or Back-Up Sources, as applicable (to
the extent a copy of such standards or equivalent policy has been provided to
Summit). The cost of any such Technology Transfer shall be borne by the Parties
as if such cost were Development Costs and Summit’s personnel costs therefor
shall be computed using the FTE Rate (pro-rated for partial FTE
usage).  Summit’s Out-of-Pocket Costs incurred in the course of such Technology
Transfers shall also be borne by the Parties as if such costs were Development
Costs, provided that such Out-of-Pocket Costs are incurred in accordance with
the agreed technology transfer plan.

7.

LICENSES; EXCLUSIVITY

7.1.

License Grants to Sarepta.

 

7.1.1.

Development, Manufacturing and Commercialization Licenses.

 

(a)

Development and Manufacturing License. Subject to the terms and conditions of
this Agreement, Summit hereby grants Sarepta a non-transferable (except as
provided in Section 14.2), sublicensable (subject to Section 7.1.2),
royalty-free, co-exclusive (with Summit) license in the Sarepta Territory and
non-exclusive license in the Summit Territory under the Summit Technology to
Develop and Manufacture (or have Manufactured) Licensed Products in the Field.

 

(b)

Commercialization License. Subject to the terms and conditions of this
Agreement, Summit hereby grants Sarepta a non-transferable (except as provided
in Section 14.2), sublicensable (subject to Section 7.1.2) exclusive (even as to
Summit) license under the Summit Technology to Commercialize Licensed Products
in the Field in the Sarepta Territory. Such license shall be royalty-bearing for
the Royalty Term applicable to each Licensed Product in each country in the
Sarepta Territory, and, after the Royalty Term applicable to such Licensed
Product in such country, shall convert to a fully-paid, irrevocable, perpetual
license to Commercialize such Licensed Product in the Field in such country.

 

7.1.2.

Sublicensing Terms.

 

(a)

Permitted Sublicensees. Subject to the requirements of this Section 7.1.2 and
the provisions of any Summit In-License, Sarepta shall have the right to
sublicense any of its rights under Section 7.1.1 to any of its Affiliates or to
any Third Party (which sublicensed rights may be further sublicensable through
multiple tiers) without the prior consent of Summit, [**].

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(b)

Sublicense Agreements. Each sublicense granted by Sarepta pursuant to this
Section 7.1.2 shall be subject and subordinate to the terms and conditions of
this Agreement and shall contain terms and conditions consistent with those in
this Agreement. Sarepta shall promptly provide Summit with a copy of the fully
executed sublicense agreement covering any sublicense granted to a Third Party
hereunder (which copy may be redacted to remove terms and conditions that are
not necessary to monitor compliance with this Section 7.1.2), and shall provide
Summit with notice identifying any Affiliate Sublicensee. Each sublicense
agreement (whether with an Affiliate or a Third Party) shall contain the
following provisions: [**].

 

(c)

Continuation of Sublicenses upon Termination of this Agreement.  If the licenses
granted to Sarepta under Section 7.1 are terminated by Summit prior to
expiration of the Term pursuant to Section 13.2.2, then, at the request of any
Sublicensee who is not then in breach of its sublicense agreement, Summit will
enter into, without any assistance by Sarepta, a direct license agreement with
such Sublicensee under the Summit Technology that is sublicensed to such
Sublicensee with substantially the same scope as set forth in such sublicense
agreement between Sarepta and such Sublicensee; provided, however, that [**].

 

(d)

Sublicensee Breach. If Sarepta becomes aware of a material breach of the terms
of any sublicense by any Sarepta Sublicensee that it is necessary for Sarepta’s
compliance with the terms of this Agreement, then Sarepta shall promptly notify
Summit of the particulars of the same and shall use Commercially Reasonable
Efforts to cause the Sublicensee to comply with all of the terms of the
sublicense agreement necessary for Sarepta’s compliance with the terms of this
Agreement. In the event that (i) the Sublicensee has failed to cure a material
breach within sixty (60) days after notice of such breach and (ii) such material
breach also constitutes a material breach of this Agreement, Sarepta shall
terminate the sublicense agreement at the request of Summit. Notwithstanding any
sublicense, Sarepta shall remain primarily liable to Summit for the performance
of all of Sarepta’s obligations under, and Sarepta’s compliance with all terms
and conditions of, this Agreement.

7.2.

License Grants to Summit.

 

7.2.1.

Development, Manufacturing and Commercialization Licenses.

 

(a)

Development and Manufacturing License. Subject to the terms and conditions of
this Agreement, Sarepta hereby grants Summit a non-transferable (except as
provided in Section 14.2), sublicensable (subject to Section 7.2.2),
non-exclusive, royalty-free license under the Sarepta Technology to Develop and
Manufacture (or have Manufactured) Licensed Products in the Field worldwide.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(b)

Commercialization License. Subject to the terms and conditions of this
Agreement, Sarepta hereby grants Summit a non-transferable (except as provided
in Section 14.2), sublicensable (subject to Section 7.2.2), non-exclusive,
royalty-free license under the Sarepta Technology to Commercialize Licensed
Products in the Field in the Summit Territory.

 

7.2.2.

Sublicensing Terms.

 

(a)

Permitted Sublicensees. Subject to the requirements of this Section 7.2.2,
Summit shall have the right to sublicense any of its rights under Section 7.2.1
to any of its Affiliates or to any Third Party (which sublicensed rights may be
further sublicensable through multiple tiers) without the prior consent of
Sarepta.

 

(b)

Sublicense Agreements. Each sublicense granted by Summit pursuant to this
Section 7.2.2 shall be subject and subordinate to the terms and conditions of
this Agreement and shall contain terms and conditions consistent with those in
this Agreement. Summit shall promptly provide Sarepta with a copy of the fully
executed sublicense agreement covering any sublicense granted hereunder (which
copy may be redacted to remove terms and conditions that are not necessary to
monitor compliance with this Section 7.2.2), and such sublicense agreement shall
contain the following provisions: [**].

 

(c)

Sublicensee Breach. If Summit becomes aware of a material breach of the terms of
any sublicense by any Summit Sublicensee that it is necessary for Summit’s
compliance with the terms of this Agreement, then Summit shall promptly notify
Sarepta of the particulars of the same and use Commercially Reasonable Efforts
to cause the Sublicensee to comply with all of the terms of the sublicense
agreement necessary for Summit’s compliance with the terms of this Agreement. In
the event that (i) the Sublicensee has failed to cure a material breach within
sixty (60) days after notice of such breach and (ii) such material breach also
constitutes a material breach of this Agreement, Summit shall terminate the
sublicense agreement at the request of Sarepta. Notwithstanding any sublicense,
Summit shall remain primarily liable to Sarepta for the performance of all of
Summit’s obligations under, and Summit’s compliance with all terms and
conditions of, this Agreement.

7.3.

In-Licenses.

 

7.3.1.

Compliance with In-Licenses.  All licenses and other rights granted to Sarepta
under this Section 7 are subject to the rights and obligations of Summit under
the Summit In-Licenses. All licenses and other rights granted to Summit under
this Section 7 are subject to the rights and obligations of Sarepta under the
Sarepta In-Licenses. As of the Effective Date there are no Sarepta In-Licenses.
Each Party shall comply with all applicable terms and conditions of the In-

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

Licenses, and shall perform and take such actions as may be required to allow
the Party that is party to such In-License to comply with its obligations
thereunder, including obligations relating to sublicensing, patent matters,
confidentiality, reporting, audit rights, indemnification and diligence;
provided that, in all cases, a Party that is not party to an In-License shall
not have any obligation to comply, or to perform such actions as may be required
to allow the other Party to comply, with any terms and conditions of such
In-Licenses that have been redacted from the copies of such In-Licenses
disclosed to such Party. Without limiting the foregoing, each Party shall
prepare and deliver to the other Party any additional reports required under the
applicable  In-Licenses, in each case sufficiently in advance to enable the
Party that is party to such In-License to comply with its obligations under the
applicable  In-Licenses. Each Party agrees, upon the other Party’s request, to
provide the other Party with copies of any In-Licenses to which it is a
party.  Confidential Information of the providing Party or its counterparty may
be redacted from such copies, except to the extent that such information is
required in order to enable the other Party to comply with its obligations to
the providing Party under this Agreement with respect to such In-License or in
order to enable the providing Party to ascertain compliance with the provisions
of this Agreement.

 

7.3.2.

Payments Under In-Licenses.  Subject to Section 8.4.6, [**]. If either Party
breaches its payment obligation to a licensor under a an In-License and the
other Party determines, in its sole discretion, to pay any such Third Party
License Payment directly to such licensor in order to cure the first Party’s
default and avoid losing the rights sublicensed to the other Party under such
In-License, then the other Party may (but will not be obligated to) make such
payments directly to such licensor. In such event either [**].

 

7.3.3.

Breach or Termination of In-Licenses.  In the event that (a) a Party receives
notice of an alleged breach by such Party under an In-License to which it is a
party or (b) a Party intends to terminate an In-License that it is a party to,
then, in either case ((a) or (b)), such Party will promptly, but in no event
less than ten (10) days thereafter, provide written notice thereof to the other
Party.

 

7.3.4.

Freedom to Obtain New In-Licenses.  For the avoidance of doubt, each Party shall
be free to enter into new In-Licenses following the Effective Date in order to
avoid infringement or misappropriation of any Third Party’s Patent Rights,
Know-How or other intellectual property rights in such Party’s Territory or
obtain access to Patent Rights, Know-How or other intellectual property that may
be reasonably necessary or useful to the Development, Manufacture or
Commercialization of Licensed Products in such Party’s Territory.  

7.4.

Bankruptcy.  All rights and licenses granted to either Party pursuant to any
section of this Agreement, including pursuant to Section 7, are licenses of
rights to “intellectual property” (as defined in Section 101(35A) of title 11 of
the United States Code (the “Bankruptcy Code”)). Each Party shall retain and may
fully exercise all of its rights and elections under the Bankruptcy Code. The
Parties further agree that, in the event of the commencement of

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

a bankruptcy proceeding by or against either Party or any of its Affiliates
(collectively, the “Bankrupt Party”) under the Bankruptcy Code or analogous
provisions of applicable Law outside the United States, the other Party (the
“Non-Bankrupt Party”), as a licensee under the Bankrupt Party’s intellectual
property, shall be entitled to a complete duplicate of (or complete access to,
as appropriate) such intellectual property and all embodiments of such
intellectual property, which, if not already in the Non-Bankrupt Party’s
possession, shall be promptly delivered to it upon the Non-Bankrupt Party’s
request therefor.

7.5.

No Other Rights.  Except as otherwise expressly provided in this Agreement,
under no circumstances shall a Party, as a result of this Agreement, obtain any
ownership interest or other right in any Know-How, Patent Rights or other
intellectual property rights of the other Party, including items owned,
controlled or developed by the other Party, or provided by the other Party to
the receiving Party at any time pursuant to this Agreement.

7.6.

Exclusivity.  During the Term and, if this Agreement is terminated by Sarepta
pursuant to Section 13.2.1 or by Summit pursuant to Section 13.2.2 or 13.2.4,
for one (1) year after such termination of this Agreement, other than as part of
the Collaboration, then neither Sarepta nor any of its Affiliates shall, itself
or with or through any Third Party, without the prior written consent of Summit,
engage in any Commercialization of any Competing Product.  Likewise, subject to
Section 2.3, during the Term, and if this Agreement is terminated by Sarepta
pursuant to Section 13.2.2, then for one (1) year after such termination of this
Agreement, other than as part of the Collaboration, neither Summit nor any of
its Affiliates shall, itself or with or through any Third Party, without the
prior written consent of Sarepta, engage in any Commercialization of any
Competing Product; [**].  

7.7.

Competing Product Acquisitions.

 

7.7.1.

Options.  If, during the term of the exclusivity covenant in Section 7.6, a
Party (the “Acquired Party”) or any of its Affiliates acquires or is acquired by
a Third Party (whether such acquisition occurs by way of a purchase of assets,
merger, consolidation or similar transaction), and where such Third Party is, at
such time, actively Commercializing a Competing Product, unless the Parties
agree otherwise in writing, then the Acquired Party, or its applicable
Affiliate, will (with respect to the applicable Competing Product), at its
option and no later than ninety (90) days following the date of consummation of
the relevant merger, consolidation or acquisition, notify the other Party in
writing of its determination to either:

 

(a)

divest, or cause the relevant Affiliate to divest, whether by license or
otherwise, its interest in the Competing Product, to the extent necessary to be
in compliance with Section 7.6;

 

(b)

terminate the Commercialization of the Competing Product; or

 

(c)

if the Acquired Party is Sarepta, terminate this Agreement pursuant to Section
13.2.1.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

7.7.2.

Divestiture or Termination.  If the Acquired Party notifies the other Party in
writing that it or its relevant Affiliate intends to divest such Competing
Product or terminate either this Agreement (if the Acquired Party is Sarepta) or
the Commercialization of the Competing Product as provided in Section 7.7.1,
then the Acquired Party or its relevant Affiliate will effect the consummation
of such divestiture within twelve (12) months or effect such termination within
six (6) months, subject to compliance with applicable Law (as applicable), after
the consummation of the relevant merger, consolidation or acquisition
contemplated in Section 7.7.1, and will confirm to the other Party in writing
when such divestiture or termination has been completed. The Acquired Party will
keep Summit reasonably informed of its efforts and progress in effecting such
divestiture or termination until it is completed.

8.

CERTAIN FINANCIAL TERMS

8.1.

Upfront Fee.  In consideration for the rights, licenses and options granted by
Summit to Sarepta under this Agreement, within ten (10) days after the Effective
Date, Sarepta shall pay Summit a non-refundable, non-creditable initial payment
of Forty Million U.S. Dollars ($40,000,000).

8.2.

Development Milestone Fees.

 

8.2.1.

First Licensed Product. Subject to the terms and conditions of this Agreement,
Sarepta shall make the non-refundable, non-creditable milestone payments to
Summit set forth in TABLE 8.2.1 below, each payable once, no later than
forty-five (45) days after the earliest date on which the corresponding
milestone event has first been achieved with respect to the first Licensed
Product to achieve such milestone event.

TABLE 8.2.1: First Licensed Product

Milestone Event

Milestone Payment

(i)  Administration of the first dose to the last patient to receive a first
dose in the PhaseOut DMD Clinical Study*

$22,000,000

(ii)  [**]

[**]

(iii)  [**]

[**]

(iv)  [**]

[**]

*Patients enrolled as part of the safety arm cohort to the PhaseOut DMD Clinical
Study shall not be considered to be patients in the PhaseOut DMD Clinical Study
for the purposes of establishing whether the last patient has been dosed in such
PhaseOut DMD Clinical Study.

 

(a)

Timing of First Milestone Payment. If the milestone event in row (i) is achieved
prior to April 1, 2017, then the milestone payment set forth in row (i) shall be
due on the later of April 1, 2017 or forty-five (45) days after the date on
which such event was achieved.

 

(b)

[**] Determination. If a [**] was not considered a [**], but later is determined
to be a [**], then the milestone event set forth in row (ii)

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

shall be deemed to have occurred on the date that such determination is made.

 

(c)

Deemed [**]. If the milestone event set forth in row (ii) of TABLE 8.2.1 has not
yet occurred, and [**] is [**] for a [**], then, upon such event, a [**] shall
also be deemed to [**] with respect to such Licensed Product for purposes of
this Section 8.2.1.

 

(d)

Deemed [**]. If the milestone event set forth in row (iii) of TABLE 8.2.1 has
not yet occurred, and a Licensed Product [**], then, upon such event, [**] shall
also be deemed to [**] for such Licensed Product for purposes of this Section
8.2.1.

 

(e)

Milestone Triggering. For the avoidance of doubt, each milestone amount set
forth in this Section 8.2.1 shall be payable no more than once, but all three
milestones need not be achieved by the same Licensed Product in order to trigger
Sarepta’s payment obligations.  For example, if a [**] with respect to a
Licensed Product, then Sarepta shall pay to Summit [**].  If the Parties then
[**] with respect to such Licensed Product [**] with respect to such Licensed
Product is [**], and [**] is then [**] with respect to a [**] Licensed Product,
then Sarepta shall be under no obligation to pay Summit for such [**]. However,
if the milestone event set forth in row (iii) of TABLE 8.2.1 has not yet
occurred and [**] in the Sarepta Territory with respect to such [**] Licensed
Product, Sarepta shall pay to Summit [**].

 

8.2.2.

Subsequent Licensed Products.  Subject to the terms and conditions of this
Agreement, after the first Regulatory Approval has been obtained for a Licensed
Product, then, with respect to each additional Licensed Product being Developed
by the Parties, on a Licensed Product-by-Licensed Product basis Sarepta shall
make the non-refundable, non-creditable milestone payments to Summit set forth
in TABLE 8.2.2, each payable once per additional Licensed Product, below no
later than forty-five (45) days after the earliest date on which the
corresponding milestone event has first been achieved with respect to each such
Licensed Product.

TABLE 8.2.2: Subsequent Licensed Products

Milestone Event

Milestone Payment

(i)  [**]

[**]

(ii) [**]

[**]

(iii) [**]

[**]

(iv)  [**]

[**]

(v) [**]

[**]

 

(a)

Cumulative Payments. If the date on which the first Regulatory Approval in the
Sarepta Territory is obtained for the first Licensed Product is later in time
than the date(s) on which one or more of the milestone events set forth in TABLE
8.2.2 above have been achieved with respect to one or

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

more other Licensed Product(s), then Sarepta shall pay all milestone payments
associated with such milestone event(s) and Licensed Product(s) within
forty-five (45) days of the date on which such first Regulatory Approval is
obtained.

 

(b)

Deemed [**]. If a [**] was not considered a [**], but later is determined to be
a [**], then the milestone event set forth in row (iii) of TABLE 8.2.2 shall be
deemed to have occurred on the date that such determination is made.

 

(c)

Deemed [**]. If the milestone event set forth in row (i) of TABLE 8.2.2 has not
yet occurred, and a [**] with respect to a Licensed Product, then, upon such
event, [**] shall also be deemed to [**] for such Licensed Product for purposes
of this Section 8.2.2.

 

(d)

Deemed [**]. If the milestone event set forth in row (ii) of TABLE 8.2.2 has not
yet occurred, and a [**] is [**] with respect to a Licensed Product, then, upon
such event a [**] shall also be deemed to [**] with respect to such Licensed
Product for purposes of this Section 8.2.2.

 

(e)

Deemed [**]. If either of the milestone events set forth in row (ii) or (iii) of
TABLE 8.2.2 has not yet occurred, and [**] for a Licensed Product is [**], then,
upon such event, a [**] shall also be deemed to [**] with respect to such
Licensed Product for purposes of this Section 8.2.2.

 

(f)

Deemed [**]. If the milestone event set forth in row (iv) of TABLE 8.2.2 has not
yet occurred, and a Licensed Product [**], then, upon such event, [**] for a
Licensed Product shall also be deemed to [**] for purposes of this Section
8.2.2.

 

8.2.3.

Option Territory Milestone Fees.  In addition to the milestone fees set forth in
Sections 8.2.1 and 8.2.2, if Sarepta exercises the Territory Expansion Option by
paying the Territory Expansion Option Fee pursuant to Section 4.2, then Sarepta
shall also make the non-refundable, non-creditable milestone payments to Summit
set forth in TABLE 8.2.3 below, no later than forty-five (45) days after the
earliest date on which the corresponding milestone event has first been achieved
with respect to the first Licensed Product to achieve such milestone event.

TABLE 8.2.3: Licensed Product in a Major Option Country

Milestone Event

Milestone Payment

(i)  [**]

[**]

(ii)  [**]

[**]

(iii) [**]

[**]

 

(a)

Deemed [**]. If the milestone event set forth in row (i) of TABLE 8.2.3 has not
yet occurred, and a Licensed Product [**] in any Major Option Country, then,
upon such event, [**] shall also be deemed to [**] for

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

such Licensed Product in each other Major Option Country for purposes of this
Section 8.2.3.

 

(b)

Milestone Triggering. The milestone payments set forth in row (i) and (ii) of
TABLE 8.2.3 shall be payable only once, regardless of how many times such
milestone is achieved. The milestone payment in row (iii) of TABLE 8.2.3 shall
be payable up to (but not more than) [**] times. However, all three milestones
in TABLE  8.2.3 need not be achieved by the same Licensed Product in order to
trigger Sarepta’s payment obligations.  For example, if [**] to a Licensed
Product in [**], then Sarepta shall pay to Summit [**].  If the Parties then
cease Development activities with respect to such Licensed Product before a [**]
is received for such Licensed Product in [**], and [**] is then [**] in [**]
with respect to a [**] Licensed Product, then Sarepta shall not be obligated to
pay Summit for the acceptance of such [**]. However, if the milestone event set
forth in row (ii) of TABLE 8.2.3 has not yet occurred and [**] for such [**]
Licensed Product in [**], then Sarepta shall pay to Summit [**].

 

8.2.4.

Notification of Milestone Events.  Sarepta shall provide Summit with written
notice of the achievement by Sarepta or any of its Related Parties of any
milestone event set forth in Sections 8.2.1, 8.2.2 or 8.2.3 within five (5) days
after such event; provided, however, that Sarepta shall inform Summit of such
event at least three (3) days prior to any public disclosure of such event by
Sarepta.

8.3.

Sales Milestone Fees.  

 

8.3.1.

Sarepta Territory Sales by Sarepta or its Related Parties. Subject to the terms
and conditions of this Agreement, on a Licensed Product-by-Licensed Product
basis, Sarepta shall make the non-refundable, non-creditable milestone payments
to Summit set forth in TABLE 8.3.1 below, each payable once, no later than
forty-five (45) days after the earliest date on which the corresponding
milestone event has first been achieved by Sarepta or its Related Parties with
respect to such Licensed Product in the Sarepta Territory.

TABLE 8.3.1: Sarepta Territory Sales Milestone Fees

Milestone Event

Milestone Payment

(i) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(ii) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(iii) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(iv) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(v) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

The milestone payments set forth in TABLE 8.3.1 above shall each be payable only
once for each Licensed Product, upon the first achievement of the applicable Net
Sales threshold with respect to such Licensed Product in a given Calendar
Year.  If more than one of such milestone events first occurs based on sales of
a Licensed Product in the same Calendar Year, then all of such milestone
payments shall be paid for such Calendar Year.

 

8.3.2.

Option Territory Sales by Sarepta or its Related Parties. Subject to the terms
and conditions of this Agreement, in addition to the sales milestone fees set
forth in Section 8.3.1, on a Licensed Product-by-Licensed Product basis, Sarepta
shall also make the non-refundable, non-creditable milestone payments to Summit
set forth in TABLE 8.3.2 below, each payable once, no later than forty-five (45)
days after the earliest date on which the corresponding milestone event has
first been achieved by Sarepta or its Related Parties with respect to such
Licensed Product in the Option Territory.

TABLE 8.3.2: Option Territory Sales Milestone Fees

Milestone Event

Milestone Payment

(i) Calendar Year Net Sales of the Licensed Product in the Option Territory
equal to or greater than [**]

[**]

(ii) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(iii) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(iv) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

(v) Calendar Year Net Sales of the Licensed Product in the Sarepta Territory
equal to or greater than [**]

[**]

The milestone payments set forth in TABLE 8.3.2 above shall each be payable only
once for each Licensed Product, upon the first achievement of the applicable Net
Sales threshold with respect to such Licensed Product in a given Calendar
Year.  If more than one of such milestone events first occurs based on sales of
a Licensed Product in the same Calendar Year, then all of such milestone
payments shall be paid for such Calendar Year.

8.4.

Royalties.

 

8.4.1.

Royalty Rates.  Subject to the terms and conditions of this Agreement, on a
Licensed Product-by-Licensed Product basis, Sarepta shall pay to Summit
royalties on the aggregate Calendar Year Net Sales of such Licensed Product in
the Sarepta Territory as set forth in TABLE 8.4.1 below:

TABLE 8.4.1: Royalty Rates

Aggregate Annual Net Sales of such Licensed Product in the Sarepta Territory

Royalty Rate

First [**]

[**]

Portion above [**] and equal to or below [**]

[**]

Portion above [**]

[**]

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

8.4.2.

Tiered Payments.  Royalties payable pursuant to this Section 8.3.2 shall be paid
at the rate applicable to the portion of Net Sales within each of the Net Sales
levels during the applicable Calendar Year for the relevant Licensed
Product.  For example, if, during a Calendar Year, aggregate Net Sales of a
Licensed Product were equal to [**], then the royalties payable by Sarepta would
be calculated by adding (a) the royalties with respect to the first [**] at the
[**] percentage of [**], equal to [**] and (b) the royalties with respect to the
next [**] at the [**] percentage of [**], equal to [**], for a total royalty of
[**].

 

8.4.3.

Royalty Term.  The term of Sarepta’s royalty obligations to Summit pursuant to
this Section 8.4 shall apply on a country-by-country and Licensed
Product-by-Licensed Product basis during the applicable Royalty Term in such
country for such Licensed Product.  Following the expiration of the applicable
Royalty Term in such country for such Licensed Product (but not following an
earlier termination of this Agreement), the licenses granted to Sarepta pursuant
to Section 7.1 with respect to such Licensed Product in such country shall be
fully-paid, irrevocable, perpetual and royalty-free, on a Licensed
Product-by-Licensed Product and country-by-country basis.

 

8.4.4.

[**].  Subject to Section 8.4.7, on a country-by-country and Licensed
Product-by-Licensed Product basis, the royalties to be paid by Sarepta to Summit
pursuant to this Section 8.4 for such Licensed Product shall be reduced to [**]
of the amounts otherwise payable pursuant to Section 8.4.1 with respect to Net
Sales in such country of the Sarepta Territory for such Licensed Product if both
[**].

 

8.4.5.

Royalty Adjustments for Generic Products.  Subject to Section 8.4.7, if, during
a given Calendar Quarter when a Licensed Product is being Commercialized by or
on behalf of Sarepta in a particular country in the Sarepta Territory, there is
Generic Competition in such country with respect to a Licensed Product, then,
subject to Section 8.4.6, the royalties payable on the Net Sales of such
Licensed Product in such country shall thereafter be reduced to [**] of the
amounts otherwise payable pursuant to Section 8.4.1 with respect to such
Licensed Product in such country for such Calendar Quarter for so long as such
Generic Competition remains. Notwithstanding the foregoing, if there is Generic
Competition for a period of [**] with respect to a Licensed Product, then
thereafter the royalty adjustment in this Section 8.4.5 will continue to apply
for the remainder of the Royalty Term applicable to such Licensed Product in
such country, regardless of whether Generic Competition continues to exist.

 

8.4.6.

Royalty Anti-Stacking.  Subject to Section 8.4.7, if Sarepta (a) determines in
good faith that, in order to avoid infringement of any Third Party’s Patent
Rights not licensed to Sarepta hereunder, it is reasonably necessary to obtain a
license after the Effective Date from a Third Party under Patent Rights owned or
licensable by such Third Party Covering such Licensed Product (but excluding any
such Patent Rights (i) to the extent Covering a use of such Licensed Product
that is not indicated in a Regulatory Approval for such Licensed Product in such

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

country or (ii) owned or licensable by a contract manufacturing organization
engaged by Sarepta) in order to Manufacture or Commercialize a Licensed Product
in the Field in a country in the Sarepta Territory and to pay a royalty under
such license (including in connection with the settlement of a patent
infringement claim) or (b) becomes subject to a final court or other binding
order or ruling requiring the payment of a royalty or damages to a Third Party
patent holder in respect of the Manufacture or Commercialization of a Licensed
Product in the Field in a country in the Sarepta Territory, then, on a
country-by-country basis, in each case, ((a) and (b)), the amount of Sarepta’s
royalty payments under Section 8.4.1 with respect to Net Sales for such Licensed
Product in such country in any Calendar Quarter shall be reduced by [**] of the
payments actually paid by Sarepta to such Third Party in consideration for such
license that are reasonably and appropriately allocable to such Licensed Product
in the Field in such country during such Calendar Quarter.

 

8.4.7.

Royalty Floor.  Notwithstanding the foregoing provisions of this Section 8.4, in
no event during the applicable Royalty Term for a Licensed Product in a country
of the Sarepta Territory shall the royalties payable to Summit hereunder for
such Licensed Product in such country for any Calendar Quarter be reduced
pursuant to Sections 8.4.4, 8.4.5 and 8.4.6 to less than [**] of the royalties
payable pursuant to Section 8.4.1 as to such Licensed Product in such country
for such Calendar Quarter.

 

8.4.8.

Reports; Payment of Royalty. During the Term, following the First Commercial
Sale of a Licensed Product in the Sarepta Territory, Sarepta shall furnish to
Summit a written report within forty-five (45) days after the end of each
Calendar Quarter showing, on a Licensed Product-by-Licensed Product and
country-by-country basis, the gross sales of each Licensed Product in each
country of the Sarepta Territory, deductions from gross sales (itemized by
deduction category) for each Licensed Product for each country of the Sarepta
Territory included in the calculation of Net Sales, the Net Sales in each
country of the Sarepta Territory of Licensed Product during the reporting period
and the royalties payable under this Agreement. Quarterly reports shall be due
no later than the forty-fifth (45th) day following the end of each Calendar
Quarter. In addition Sarepta shall prepare and deliver to Summit any additional
reports as required under the Summit In-Licenses. Royalties shown to have
accrued by each royalty report shall be due and payable on the date such royalty
report is due. Sarepta and its Related Parties shall keep complete and accurate
records in sufficient detail to enable the royalties and other payments payable
hereunder and by Summit to Third Parties under the Summit In-Licenses to be
determined.

8.5.

Audits.

 

8.5.1.

Records; Inspections.  Each Party shall keep complete and accurate records of
the items underlying Development Costs, Declined NG Candidate Development Costs,
Net Sales, Cost of Goods, royalties, milestones, other license fees and other
payments under this Agreement.  Upon the written request of a Party and

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

not more than once in each Calendar Year, the other Party and its Related
Parties shall permit an independent certified public accounting firm of
internationally-recognized standing selected by the requesting Party and
reasonably acceptable to the other Party, at the requesting Party’s expense
except as set forth below, to have access during normal business hours to such
of the records of the other Party as may be reasonably necessary to verify the
accuracy of the payments and reports hereunder for any year ending not more than
three (3) years prior to the date of such request for the sole purpose of
verifying the basis and accuracy of payments made under this Agreement.

 

8.5.2.

Discrepancies.  If such accounting firm identifies a discrepancy made during
such period, then the appropriate Party shall pay the other Party the amount of
the discrepancy (together with, in the case of any underpayments, late-payment
interest in accordance with Section 8.7) within fifteen (15) days after the date
the requesting Party delivers to the other Party such accounting firm’s written
report so concluding, or as otherwise agreed by the Parties in writing.  The
fees charged by such accounting firm shall be paid by the requesting Party,
unless such discrepancy represents an underpayment by the other Party of at
least [**] of the total amounts due hereunder in the audited period, in which
case such fees shall be paid by the other Party.

 

8.5.3.

Compliance with In-Licenses.  Each Party shall comply with all applicable audit
requirements in the In-Licenses and shall include in each sublicense granted by
it pursuant to this Agreement a provision requiring the Sublicensee to make
reports to the Party that is party to such In-License, to keep and maintain
records of sales made pursuant to such sublicense and to grant access to such
records by the independent accountant of the Party that is party to such
In-License to the same extent required of a Party under this Agreement.

 

8.5.4.

Audit Term.  Unless an audit for such year has been commenced prior to and is
ongoing upon the third (3rd) anniversary of the end of such year, the
calculation of payments payable with respect to such year shall be binding and
conclusive upon both Parties, and each Party and its Related Parties shall be
released from any further liability or accountability with respect to such
royalties or expense reimbursement for such year.

 

8.5.5.

Confidential Treatment.  Each Party shall treat all financial information
subject to review under this Section 8.5 or under any sublicense agreement in
accordance with the confidentiality and non-use provisions of this Agreement,
and shall cause its accounting firm to enter into a written confidentiality
agreement with the other Party or its Related Parties obligating it to retain
all such information in confidence pursuant to such confidentiality agreement,
which terms shall be no less stringent than the provisions of Section 9.

8.6.

Payment Exchange Rate.  Each payment to be made to Summit under this Agreement
shall be made in such currency and to such bank account in the United Kingdom as
may be designated in writing by Summit from time to time. All payments to be
made under this

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Agreement to Sarepta shall be made in United States dollars and shall be paid by
bank wire transfer in immediately available funds to such bank account in the
United States as may be designated in writing by Sarepta from time to time. If,
in a given Calendar Quarter, either Party is required to convert between
currencies in order to make a payment in accordance with this Section 8.6, then
such Party shall make such conversion using the average rate of exchange for
such Calendar Quarter utilized by such Party in its worldwide accounting system
and calculated in accordance with GAAP.

8.7.

Late Payments.  Any amount owed by a Party to the other Party under this
Agreement that is not paid on or before the date such payment is due shall bear
interest at a rate per annum equal to the lesser of (a) the then-current one (1)
month London Inter-Bank Offering Rate for US Dollars, as quoted on the British
Banker’s Association’s website currently located at www.bba.org.uk (or such
other source as may be mutually agreed by the Parties) plus [**] per annum or
(b) the highest rate permitted by Law, calculated on the number of days such
payments are paid after such payments are due and compounded monthly.

8.8.

Blocked Payments.  If, by reason of applicable Laws in any jurisdiction in a
Party’s Territory, it becomes impossible or illegal for a Party to transfer
milestone payments, royalties or other payments under this Agreement to the
other Party, then the payor shall promptly notify the payee. During any such
period described above, the payor shall deposit such payments in local currency
in the relevant jurisdiction to the credit of the payee in a recognized banking
institution designated by the payee or, if none is designated by the payee
within a period of ninety (90) days, in a recognized banking institution
selected by the payor and identified in a written notice given to the payee.

8.9.

Taxes.  If a timely and appropriately completed and executed Internal Revenue
Service Form W-9 is provided by the receiving Party to the paying Party, then
the Parties acknowledge and agree that no United States tax withholding shall be
applied with respect to the payments due under this Agreement. Each Party shall
use reasonable efforts to minimize tax withholding on payments made to the other
Party. Notwithstanding such efforts, if such Party concludes that tax
withholdings under the Laws of any country are required with respect to payments
to the other Party, then such Party shall first notify the other Party and
provide such Party with twenty (20) days to determine whether there are actions
such receiving Party can undertake to avoid such withholding. During this notice
period, the paying Party shall refrain from making such payment until the
receiving Party instructs the paying Party that (a) the receiving Party intends
to take actions (satisfactory to both Parties) that will obviate the need for
such withholding, in which case the paying Party shall make such payment only
after it is instructed to do so by the receiving Party or (b) the paying Party
should make such payment and withhold the required amount and pay it to the
appropriate Governmental Authority. In such case, the withholding Party shall
promptly provide the other Party with copies of receipts or other evidence
reasonably required and sufficient to allow the other Party to document such tax
withholdings adequately for purposes of claiming foreign tax credits and similar
benefits. The Parties will cooperate reasonably in completing and filing
documents required under the provisions of any applicable tax laws or under any
other applicable Law, in connection with the making of any required tax payment
or withholding payment, or in connection with any claim to a refund of or credit
for any such payment. The Parties will cooperate to

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

minimize such taxes in accordance with applicable Laws, including using
reasonable efforts to access the benefits of any applicable treaties.
Notwithstanding the foregoing, if, as a result of (y) the assignment of this
Agreement by Sarepta to an Affiliate or a Third Party outside of the United
States or (z) the exercise by Sarepta of its rights under this Agreement through
an Affiliate or Third Party outside of the United States (or the direct exercise
of such rights by an Affiliate of Sarepta outside of the United States), foreign
withholding tax in excess of the foreign withholding tax amount that would have
been payable in the absence of such assignment or exercise of rights becomes
payable with respect to amounts due to Summit hereunder, then such amount due to
Summit will be increased so that the amount actually paid to Summit equals the
amount that would have been payable to Summit in the absence of such excess
withholding (after withholding of the excess withholding tax and any additional
withholding tax on such increased amount). However, if a similar assignment or
exercise of rights described in clauses (y) or (z) of the preceding sentence by
Summit results in foreign withholding tax in excess of the foreign withholding
tax amount that would have been payable in the absence of such assignment or
exercise of rights, then any amount due to Summit will not be increased for such
excess withholding and, subject to the terms of this Agreement, the required
amount will be withheld and submitted to the appropriate Governmental Authority.

9.

CONFIDENTIALITY AND PUBLICATION

9.1.

Nondisclosure Obligation.

 

9.1.1.

Non-Disclosure and Non-Use; Exceptions. During the Term and for a period of five
(5) years thereafter, all Confidential Information disclosed by one Party to the
other Party hereunder shall be maintained in confidence by the receiving Party
and shall not be disclosed to a Third Party or used for any purpose except as
set forth herein without the prior written consent of the disclosing Party,
except to the extent that such Confidential Information:

 

(a)

is known by the receiving Party at the time of its receipt, and not through a
prior disclosure by the disclosing Party, as documented by the receiving Party’s
business records;

 

(b)

is known to the public before its receipt from the disclosing Party, or
thereafter becomes generally known to the public through no breach of this
Agreement by the receiving Party;

 

(c)

is subsequently disclosed to the receiving Party by a Third Party who is not
known by the receiving Party to be under an obligation of confidentiality to the
disclosing Party; or

 

(d)

is developed by the receiving Party independently of Confidential Information
received from the disclosing Party, as documented by the receiving Party’s
business records.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

9.1.2.

Permitted Disclosures.  Notwithstanding the obligations of confidentiality and
non-use set forth above, a receiving Party may provide Confidential Information
disclosed to it, and disclose the existence and terms of this Agreement, as may
be reasonably required in order to perform its obligations and to exploit its
rights under this Agreement, and specifically to (a) Related Parties, and their
employees, directors, agents, consultants, advisors or other Third Parties for
the performance of its obligations hereunder (or for such entities to determine
their interest in performing such activities) in accordance with this Agreement
in each case, who are under an obligation of confidentiality with respect to
such information that is no less stringent than the terms of this Section 9; (b)
governmental or other Regulatory Authorities in order to obtain patents or
perform its obligations or exploit its rights under this Agreement; provided
that such Confidential Information shall be disclosed only to the extent
reasonably necessary to do so, (c) the extent required by Law, including by the
rules or regulations of the United States Securities and Exchange Commission or
similar regulatory agency in a country other than the United States or of any
stock exchange or listing entity, (d) any bona fide actual or prospective
acquirers, underwriters, investors, lenders or other financing sources and any
bona fide actual or prospective licensee, sublicensees, collaborators or
strategic partners and to consultants and advisors of such Party, in each case,
who are under an obligation or confidentiality with respect to such information
that is no less stringent than the terms of this Section 9 and (e) to Third
Parties to the extent a Party is required to do so pursuant to the terms of an
Existing Summit In-License. If a Party is required by Law to disclose
Confidential Information that is subject to the non-disclosure provisions of
this Section 9, then such Party shall promptly inform the other Party of the
disclosure that is being sought in order to provide the other Party an
opportunity to challenge or limit the disclosure obligations. Confidential
Information that is required to be disclosed by Law shall remain otherwise
subject to the confidentiality and non-use provisions of this Section 9. If
either Party concludes that a copy of this Agreement must be filed with the
United States Securities and Exchange Commission or similar regulatory agency in
a country other than the United States, then such Party will provide the other
Party with a copy of this Agreement showing any provisions hereof as to which
the Party proposes to request confidential treatment, will provide the other
Party with an opportunity to comment on any such proposed redactions and to
suggest additional redactions and will take such Party’s reasonable comments
into consideration before filing the Agreement.

9.2.

Publication and Publicity.

 

9.2.1.

Publication.  Sarepta and Summit each acknowledge the other Party’s interest in
publishing certain key results of the Collaboration. Each Party also recognizes
the mutual interest in obtaining valid patent protection and in protecting trade
secret information. Consequently, except for disclosures permitted pursuant to
Section 9.1 and Section 9.2.3, either Party wishing to make a publication or
public presentation that contains the Confidential Information of the other
Party shall deliver to the other Party a copy of the proposed written

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

publication or presentation a reasonable period of time prior to submission for
publication or presentation. The reviewing Party shall have the right (a) to
propose modifications to the publication or presentation for patent reasons,
trade secret reasons or business reasons, and the publishing Party will remove
all Confidential Information of the other Party if requested by the reviewing
Party and (b) to request a reasonable delay in publication or presentation in
order to protect patentable information. If the reviewing Party requests a
delay, then the publishing Party shall delay submission or presentation for a
period of ninety (90) days (or such shorter period as may be mutually agreed by
the Parties) to enable the non-publishing Party to file patent applications
protecting such Party’s rights in such information in accordance with Section
12. With respect to any proposed publications or disclosures by investigators or
academic or non-profit collaborators, such materials shall be subject to review
under this Section 9.2.1 to the extent that Sarepta or Summit, as the case may
be, has the right and ability (after using Commercially Reasonable Efforts to
obtain such right and ability) to do so.

 

9.2.2.

Publicity; Use of Names.  Except as set forth in Section 9.1 and Section 9.2.3,
no Party shall use the name, trademark, trade name or logo of the other Party or
its employees in any publicity, news release or disclosure relating to this
Agreement or its subject matter without the prior express written permission of
the other Party, except as may be required by Law or expressly permitted by the
terms hereof.

 

9.2.3.

Press Release.  Following the execution of this Agreement, the Parties shall
issue a joint press release in the form set forth in Schedule 9.2.3. After such
initial press release, neither Party shall issue press releases or make public
disclosures relating to this Agreement or the terms hereof, including relating
to the Development, Manufacture or Commercialization of Licensed Products,
unless (a) the information in such release or disclosure has been previously
publicly disclosed and is materially true and correct at the time of the
subsequent disclosure or (b) the Party making the disclosure provides the other
Party with a draft of such proposed disclosure at least two (2) business days
(or, to the extent timely disclosure of a material event is required by Law or
stock exchange or stock market rules, such period of time sufficiently in
advance of the disclosure so that the other Party will have the opportunity to
comment upon the disclosure) prior to making any such disclosure, for the other
Party’s review and comment, and the disclosing Party shall consider in good
faith any timely comments provided by the other Party.

10.

REPRESENTATIONS, WARRANTIES AND COVENANTS

10.1.

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

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

10.1.1.

It is duly organized and validly existing under the laws of its jurisdiction of
incorporation or formation, and has full corporate or other power and authority
to enter into this Agreement, and to carry out the provisions hereof.

 

10.1.2.

It is duly authorized to execute and deliver this Agreement, and to perform its
obligations hereunder, and the person or persons executing this Agreement on its
behalf has been duly authorized to do so by all requisite corporate action.

 

10.1.3.

This Agreement is legally binding upon it and enforceable in accordance with its
terms. The execution, delivery and performance of this Agreement by it does not
conflict with any agreement, instrument or understanding, oral or written, to
which it is a party and by which it may be bound, or with its charter or
by-laws.

 

10.1.4.

It has not granted any right to any Third Party that would conflict with the
rights granted to the other Party hereunder.

 

10.1.5.

Neither Party nor any of its Affiliates has been debarred or is subject to
debarment pursuant to Section 306 of the United States Federal Food, Drug, and
Cosmetic Act, as amended, or that is the subject of a conviction described in
such section.

10.2.

Representations and Warranties of Summit. Summit represents and warrants to
Sarepta that as of the Effective Date:

 

10.2.1.

Ownership or Control.  Summit is the sole and exclusive owner of all Summit
Patent Rights set forth on Schedule 1.89 as of the Effective Date.  All of such
Summit Technology solely and exclusively owned by Summit is free and clear of
claims, liens, charges or encumbrances that are inconsistent with the rights
granted to Sarepta under this Agreement.

 

10.2.2.

Authority. Summit has sufficient legal or beneficial title and ownership of, or
sufficient license rights under, the Summit Technology to grant the licenses to
such Summit Technology granted to Sarepta pursuant to this Agreement.

 

10.2.3.

Summit Patent Rights.  (a) Schedule 1.89 collectively sets forth a complete and
accurate list of the Summit Patent Rights, (b) to Summit’s knowledge, each
issued Summit Patent Right remains in full force and effect and (c) Summit or
its Affiliates have paid all filing and renewal fees required to be paid on or
before the Effective Date with respect to such Summit Patent Rights.

 

10.2.4.

Completeness of Schedules.  Other than the Summit Patent Rights set forth on
Schedule 1.89, Summit does not Control any Patent Rights that Cover any
Collaboration Compound or Licensed Product.

 

10.2.5.

Infringement.  To Summit’s knowledge, the Development, Manufacture and
Commercialization of Benzoxazole Collaboration Compounds or Benzoxazole Licensed
Products will not infringe the intellectual property rights of any Third Party.
Except for Know-How and Patent Rights Controlled by contract

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

manufacturers engaged by Summit as of the Effective Date, Summit Controls all
Know-How, and to its knowledge Controls all Patent Rights, in each case, used in
the Manufacture, Development and Commercialization of the Licensed Products.
There is (a) no claim, action or proceeding pending, (b) no written
communication (other than general letters received by Summit regarding assays
not specific to any Collaboration Compound) or (c) to Summit’s knowledge, no
threatened claim, action or proceeding, in each case ((a), (b) and (c)) alleging
that the Development, Manufacture or Commercialization of any Collaboration
Compound or Licensed Product, the activities of Summit or any of its Affiliates
with respect to any such Collaboration Compound or Licensed Product, or the
practice or use of the Summit Patent Rights or Summit Know-How, infringes or
misappropriates any Patent Rights or other intellectual property of any Third
Party.

 

10.2.6.

Validity.  To Summit’s knowledge, the Summit Patent Rights in the Sarepta
Territory existing as of the Effective Date, are, or, upon issuance, will be,
valid and enforceable patents and no Third Party has challenged or threatened to
challenge the scope, validity or enforceability of any such Summit Patent Right
(including, by way of example, through opposition or the institution or written
threat of institution of interference, nullity or similar invalidity proceedings
before the United States Patent and Trademark Office or any analogous foreign
Governmental Authority).

 

10.2.7.

Diligent Prosecution and Maintenance.  Summit and its Affiliates have complied
with all applicable Laws, including any duties of candor to applicable patent
offices, in connection with the filing, prosecution and maintenance of the
Summit Patent Rights existing as of the Effective Date.

 

10.2.8.

Existing Summit In-Licenses.  Subject to the “Non-Commercial Use” (as defined in
the University of Oxford Option Agreement) rights retained by Oxford under the
University of Oxford Option Agreement, and the rights retained by Oxford to the
extent Summit does not exercise the options therein, none of the Existing Summit
In-Licenses (or any agreement to which Summit is a party) contain provisions
that conflict with the exclusive rights and licenses granted to Sarepta
hereunder or cause Summit to cease to Control any Summit Technology.

 

10.2.9.

No Defaults under Existing Summit In-Licenses.  To Summit’s knowledge, neither
Summit nor its Affiliates are in breach or default under any Existing Summit
In-License, and neither Summit nor its Affiliates have received any written
notice of breach or default with respect to any Existing Summit In-License.

 

10.2.10.

Invention Assignments.  Summit has obtained from all inventors of Summit
Technology owned by Summit as of the Effective Date valid and enforceable
agreements assigning to Summit each such inventor’s entire right, title and
interest in and to all such Summit Technology.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

10.2.11.

Absence of Litigation.  There is no (a) claim, demand, suit, proceeding,
arbitration, inquiry, investigation or other legal action of any nature, civil,
criminal, regulatory or otherwise, pending or, to Summit’s knowledge, threatened
against Summit or any of its Affiliates or (b) judgment or settlement against or
owed by Summit or any of its Affiliates, in each case, in connection with the
Summit Technology existing as of the Effective Date.

10.3.

Representations and Warranties of Sarepta.  Sarepta represents and warrants to
Summit as of the Effective Date that is not a party to any agreement with a
Third Party under which it Controls Know-How or Patent Rights that are
reasonably necessary or useful to Develop or Commercialize Licensed Products in
the Field in the Summit Territory or that would require Summit to make any
payment in connection with Summit’s or its Related Parties’ Development or
Commercialization of Licensed Products in the Field in the Summit Territory.

10.4.

Warranty Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY,
LICENSED PRODUCT, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS
AGREEMENT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT WITH RESPECT TO ANY AND
ALL OF THE FOREGOING. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY
THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF THE LICENSED PRODUCTS
PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL
WITH RESPECT TO THE LICENSED PRODUCTS WILL BE ACHIEVED.

10.5.

Mutual Covenants.

 

10.5.1.

Non-Contravention.  During the Term, neither Party, nor its Related Parties,
will grant any right to any Third Party that would conflict with the rights
granted to the other Party hereunder.  Each Party will comply with each
In-License to which it is a Party and will not materially breach or otherwise
take any action that would permit the licensor thereunder to terminate such
In-License without the prior written consent of the other Party if such
termination would adversely affect the rights of the other Party hereunder.

 

10.5.2.

Compliance with Laws.  Each Party and its Related Parties shall conduct the
Collaboration and the Development, Manufacture and Commercialization of the
Licensed Products in accordance with all Laws, including applicable governmental
regulations concerning good laboratory practices, good clinical practices and
good manufacturing practices.

 

10.5.3.

Debarment.  Neither Party nor any of its Affiliates will use in any capacity, in
connection with the Collaboration or the performance of its obligations under

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

this Agreement, any Person that has been debarred pursuant to Section 306 of the
United States Federal Food, Drug, and Cosmetic Act, as amended, or that is the
subject of a conviction described in such section. Each Party agrees to inform
the other Party in writing immediately if it or any Person that is performing
activities in the Collaboration or under this Agreement, is debarred or is
subject to debarment or is the subject of a conviction described in Section 306,
or if any action, suit, claim, investigation or legal or administrative
proceeding is pending or, to the best of the notifying Party’s knowledge, is
threatened, relating to the debarment or conviction of the notifying Party or
any Person used in any capacity by such Party or any of its Affiliates in
connection with the Collaboration or the performance of its other obligations
under this Agreement.

10.6.

Summit Spending Commitment. So long as Development activities with respect to
the Benzoxazole Licensed Product have not ceased, Summit shall spend a total of
at least [**] in the performance of its activities under the Development Plan
prior to the end of 2019.

11.

INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

11.1.

General Indemnification by Sarepta.  Sarepta shall indemnify, hold harmless, and
defend Summit, its Related Parties, and their respective directors, officers,
employees and agents (“Summit Indemnitees”) from and against any and all Third
Party claims, suits, losses, liabilities, damages, costs, fees and expenses
(including reasonable attorneys’ fees and litigation expenses) (collectively,
“Losses”) arising out of or resulting from, directly or indirectly, (a) any
breach of, or inaccuracy in, any representation or warranty made by Sarepta in
this Agreement, or any breach or violation of any covenant or agreement of
Sarepta in or in the performance of this Agreement or (b) the negligence or
willful misconduct by or of Sarepta or its Related Parties, and their respective
directors, officers, employees and agents in the performance of Sarepta’s
obligations under this Agreement. Sarepta shall have no obligation to indemnify
the Summit Indemnitees to the extent that the Losses arise out of or result
from, directly or indirectly, any breach of, or inaccuracy in, any
representation or warranty made by Summit in this Agreement, or any breach or
violation of any covenant or agreement of Summit in or in the performance of
this Agreement, or the negligence or willful misconduct by or on behalf of any
of the Summit Indemnitees, or matters for which Summit is obligated to indemnify
Sarepta under Section 11.2 or Section 11.3.

11.2.

General Indemnification by Summit.  Summit shall indemnify, hold harmless, and
defend Sarepta, its Related Parties and their respective directors, officers,
employees and agents (“Sarepta Indemnitees”) from and against any and all Losses
arising out of or resulting from, directly or indirectly, (a) any breach of, or
inaccuracy in, any representation or warranty made by Summit in this Agreement,
or any breach or violation of any covenant or agreement of Summit in or in the
performance of this Agreement or (b) the negligence or willful misconduct by or
of Summit or its Related Parties, and their respective directors, officers,
employees and agents in the performance of Summit’s obligations under this
Agreement. Summit shall have no obligation to indemnify the Sarepta Indemnitees
to the extent that the Losses arise out of or result from, directly or
indirectly, any breach of, or inaccuracy in, any representation or warranty made
by Sarepta in this Agreement, or any

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

breach or violation of any covenant or agreement of Sarepta in or in the
performance of this Agreement, or the negligence or willful misconduct by or on
behalf of any of the Sarepta Indemnitees, or matters for which Sarepta is
obligated to indemnify Summit under Section 11.1 or Section 11.3.

11.3.

Product Liability.  Any Losses arising out of Third Party product liability
claims arising from manufacturing defects in Licensed Products Manufactured by
Summit shall be borne by Summit.  Any other Losses arising out of Third Party
product liability claims arising from the Development or Commercialization of
Licensed Products shall be (a) borne by Sarepta, to the extent such Losses were
incurred with respect to the Development or Commercialization of the Licensed
Products in or for the Sarepta Territory by or on behalf of Sarepta and its
Related Parties and (b) be borne by Summit, to the extent such Losses were
incurred with respect to Development or Commercialization of the Licensed
Products in or for the Summit Territory by or on behalf of Summit and its
Related Parties. The Party bearing such Losses in accordance with this Section
11.3 shall indemnify, hold harmless and defend the other Party and its Related
Parties and their respective directors, officers, employees and agents from and
against such Losses.

11.4.

Indemnification Procedure.  In the event of any indemnified claim against any
Sarepta Indemnitee or Summit Indemnitee (individually, an “Indemnitee”), the
indemnified Party shall promptly notify the other Party in writing of the claim
and the indemnifying Party shall manage and control, at its sole expense, the
defense of the claim and its settlement; provided, however, that the
indemnifying Party may not settle the claim without the indemnified Party’s
prior written consent (not to be unreasonably withheld), if such settlement
materially adversely impacts the indemnified Party’s rights or obligations. The
Indemnitee shall cooperate with the indemnifying Party and may, at its option
and expense, be represented in any such action or proceeding. The indemnifying
Party shall not be liable for any settlements, litigation costs or expenses
incurred by any Indemnitee without the indemnifying Party’s written
authorization. Notwithstanding the foregoing, if the indemnifying Party believes
that any of the exceptions to its obligation of indemnification of the
Indemnitees set forth in Sections 11.1, 11.2 or 11.3 may apply, then the
indemnifying Party shall promptly notify the Indemnitees, who shall then have
the right to be represented in any such action or proceeding by separate counsel
at their expense; provided that the indemnifying Party shall be responsible for
payment of such expenses if the Indemnitees are ultimately determined to be
entitled to indemnification from the indemnifying Party for the matters to which
the indemnifying Party notified the Indemnitees that such exception(s) may
apply.

11.5.

Limitation of Liability.  NEITHER PARTY WILL BE LIABLE FOR SPECIAL, INDIRECT,
INCIDENTAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES, EXCEPT AS A RESULT OF A PARTY’S WILLFUL MISCONDUCT OR A
BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN SECTION 9. NOTHING IN
THIS SECTION 11.5 IS INTENDED

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.

11.6.

Insurance.  Each Party shall maintain insurance during the Term and for a period
of at least two (2) years after the last commercial sale of any Licensed Product
under this Agreement, with a reputable, solvent insurer in an amount appropriate
for its business and products of the type that are the subject of this
Agreement, and for its obligations under this Agreement. Specifically, each
Party shall maintain product liability insurance and clinical trial liability
insurance with limits of at least [**] per occurrence and in annual aggregate.
Upon request, each Party shall provide the other Party with evidence of the
existence and maintenance of such insurance coverage.

12.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

12.1.

Ownership.  Except as otherwise expressly set forth in this Agreement, Summit
retains all of its rights, title and interests in and to the Summit Patent
Rights, and Summit Know-How and Sarepta retains all of its rights, title and
interests in and to the Sarepta Patent Rights and Sarepta Know-How. Each Party
shall own the entire right, title and interest in and to all Know-How (and
Patent Rights claiming patentable inventions therein) first made or invented
solely by the employees or consultants of such Party in the course of the
Collaboration.  The Parties shall jointly own or Control all rights, title and
interests in and to the Collaboration Technology.  Inventorship shall be
determined in accordance with U.S. patent Laws.

 

12.1.1.

Right to Practice Collaboration Technology.  Subject to the rights and licenses
granted to, and the obligations of, each Party pursuant to this Agreement, each
Party is entitled to exploit and practice Collaboration Technology for all
purposes on a worldwide basis and to license Collaboration Technology, in each
case, without consent of and without a duty of accounting to the other Party.
Each Party will grant and hereby does grant all permissions, consents and
waivers with respect to, and all licenses under, the Collaboration Technology,
throughout the world, necessary to provide the other Party with such rights of
use and exploitation of the Collaboration Technology, and will execute documents
as necessary to accomplish the foregoing.

 

12.1.2.

Disclosure.  Each Party shall promptly disclose to the other Party any invention
disclosures, or other similar documents, submitted to it by its employees,
agents or independent contractors during the Term describing Collaboration
Know-How or any Sarepta Know-How or Summit Know-How made or invented in the
course of the Collaboration and shall notify the other Party if it intends to
file any patent application disclosing or claiming any such Know-How or
invention. In addition, each Party will disclose to the other Party any such
information related to such technology, to the extent patentable, necessary for
the filing, prosecution or maintenance of any Patent Right Covering
Collaboration Know-How, Summit Know-How or Sarepta Know-How in accordance with
the terms and conditions of this Article 12.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

12.1.3.

Employee Assignment Obligations; Third Party Intellectual Property
Agreements.  Each Party shall ensure that all of its employees and all of its
Affiliates’ employees acting under its or its Affiliates’ authority in the
performance of this Agreement assign to such Party under a binding written
agreement all Know-How and Patent Rights discovered, made or conceived by such
employee as a result of such employee’s employment.  In addition, each Party
shall use Commercially Reasonable Efforts to include in agreements between such
Party and its Affiliates, on the one hand, and Third Parties engaged under such
agreements to perform activities under this Agreement that are reasonably
expected to generate Know-How or Patent Rights, on the other hand, binding
agreements granting such Party Control of such generated Know-How and Patent
Rights that are reasonably necessary or useful for the Development, Manufacture
and Commercialization of Licensed Products hereunder; provided that, in entering
into such a Third Party agreement, a Party may, in the exercise of reasonable
business judgment, accept less than such rights if such Party determines that
such rights cannot be obtained from such Third Party on commercially reasonable
terms and that such agreement is nonetheless consistent with and advisable to
further the Parties’ related Development, Manufacturing and Commercialization
goals under this Agreement.

12.2.

Prosecution and Maintenance of Patent Rights.

 

12.2.1.

Sarepta Patent Rights.  Sarepta has the sole responsibility to, at Sarepta’s
discretion, file, prosecute and maintain, all Sarepta Patent Rights, in
Sarepta’s name.

 

12.2.2.

Summit Patent Rights and Collaboration Patent Rights.

 

(a)

Responsibility. Subject to Section 12.2.2(c), Summit has the sole responsibility
to, at Summit’s discretion, file, prosecute and maintain, all Summit Patent
Rights in Summit’s name and Collaboration Patent Rights jointly in the name of
each Party, in the case of Collaboration Patent Rights, using counsel reasonably
acceptable to Sarepta. Summit agrees to use Commercially Reasonable Efforts to
prosecute and maintain all Summit Patent Rights and Collaboration Patent Rights
throughout the world; [**].

 

(b)

Consultation with Sarepta. Notwithstanding the foregoing Section 12.2.2(a),
Summit shall consult with Sarepta on the preparation, filing, prosecution and
maintenance of all Summit Patent Rights and Collaboration Patent Rights
throughout the world. Summit shall furnish Sarepta with copies of documents
relevant to such preparation, filing, prosecution and maintenance in sufficient
time prior to filing such document or making any payment due thereunder to allow
for review and comment by Sarepta and shall consider in good faith timely
comments from Sarepta thereon. Summit shall also furnish Sarepta with copies of
all final filings and responses made to any patent authority with

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

respect to all such Patent Rights in a timely manner following submission
thereof.

 

(c)

Sarepta Step-In Right. In the event that Summit elects not to file, prosecute or
maintain patent protection on any Summit Patent Rights or Collaboration Patent
Rights in the Sarepta Territory, subject to the terms and conditions of any
applicable Summit In-License, Sarepta shall have the right (but not the
obligation), at its expense, to file, prosecute and maintain in any country
patent protection on such abandoned Patent Rights in the Sarepta Territory. If
Sarepta exercises such step-in right, then (i) Sarepta will control, and have
final decision making authority with respect to, the filing, prosecution and
maintenance of applicable Summit Patent Rights or Collaboration Patent Rights at
its sole cost and expense and (ii) Sarepta shall have the right to offset [**]
of all reasonable Out-of-Pocket Costs arising from such prosecution and
maintenance against any royalties that become payable to Summit hereunder with
respect to Licensed Products Covered by such Summit Patent Rights or
Collaboration Patent Rights based on Net Sales in the applicable country(ies) of
the Sarepta Territory. In addition, Summit shall use Commercially Reasonable
Efforts to make available to Sarepta its authorized attorneys, agents or
representatives, and such of its employees, in each case, as are reasonably
necessary to assist Sarepta in obtaining and maintaining the patent protection
described under this Section 12.2.2. Summit shall sign or use Commercially
Reasonable Efforts to have signed all legal documents necessary to file and
prosecute such patent applications or to obtain or maintain such patents.

 

12.2.3.

Cooperation.  Each Party hereby agrees: (a) to make its employees, agents and
consultants reasonably available to the other Party (or to the other Party’s
authorized attorneys, agents or representatives), to the extent reasonably
necessary to enable such Party to undertake patent prosecution; (b) to provide
the other Party with copies of all material correspondence pertaining to
prosecution with the patent offices; (c) to cooperate, if necessary and
appropriate, with the other Party in gaining patent term extensions wherever
applicable to Patent Rights licensed under this Agreement and (d) to endeavor in
good faith to coordinate its efforts with the other Party to minimize or avoid
interference with the prosecution and maintenance of the other Party’s patent
applications.

12.3.

Infringement by Third Parties; Defense Actions.

 

12.3.1.

Notices.  Each Party shall promptly report in writing to the other Party any (a)
known or suspected infringement of any Summit Technology or Sarepta Technology
or (b) unauthorized use or misappropriation of any Confidential Information or
Know-How of a Party by a Third Party of which it becomes aware, in each case, to
the extent such infringing, unauthorized or misappropriating activities involve,
as to a Licensed Product, a competing

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

product in the Field ((a) and (b) collectively, “Competitive Infringement”), (c)
Third Party’s challenge to the validity, scope or enforceability of a Summit
Patent Right, Sarepta Patent Right or Collaboration Patent Right or (d)
initiation by a Third Party of any opposition or inter partes review proceeding
against any Summit Patent Right, Sarepta Patent Right or Collaboration Patent
Right (a “Defense Action”), and shall provide the other Party with all available
evidence and information regarding such Competitive Infringement or Defense
Action.

 

12.3.2.

Rights to Enforce and Defend.

 

(a)

Sarepta Territory. Sarepta shall have the sole and exclusive right to initiate
an infringement or other appropriate suit or administrative proceeding in the
Sarepta Territory against any Third Party as to any Competitive Infringement in
the Sarepta Territory of any Sarepta Technology, and, Sarepta shall have the
first right, but not the obligation, to initiate an infringement or other
appropriate suit or administrative proceeding in the Sarepta Territory against
any Third Party as to any Competitive Infringement in the Sarepta Territory of
any Summit Technology (subject to the provisions of any Summit In-License) or
Collaboration Technology. Likewise, Sarepta will have the first right, but not
the obligation, to defend against any Defense Action in the Sarepta Territory
relating to a Summit Patent Right (subject to the provisions of any Summit
In-License) or Collaboration Patent Right, and will have the sole and exclusive
right to defend any Defense Action in the Sarepta Territory relating to a
Sarepta Patent Right.

 

(b)

Summit Territory. Summit shall have the sole and exclusive right to initiate an
infringement or other appropriate suit or administrative proceeding in the
Summit Territory against any Third Party as to any Competitive Infringement in
the Summit Territory of any Summit Technology, and Summit shall have the first
right, but not the obligation, to initiate an infringement or other appropriate
suit or administrative proceeding in the Summit Territory against any Third
Party as to any Competitive Infringement in the Summit Territory of any Sarepta
Technology (subject to the provisions of any Sarepta In-License) or
Collaboration Technology. Likewise, Summit will have the sole and exclusive
right, but not the obligation, to defend against any Defense Action in the
Summit Territory relating to the Summit Patent Rights and shall have the first
right, but not the obligation, to defend any Defense Action in the Summit
Territory relating to the Collaboration Patent Rights or Sarepta Patent Rights
(subject to the provisions of any Sarepta In-License).

 

(c)

Step-In Right. If within [**] after a Party’s receipt of a notice of a
Competitive Infringement or Defense Action (or such lesser time so that the
other Party’s rights are not prejudiced by the delay)  with respect to which
such Party has the first right (but not sole and exclusive right) to

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

initiate an infringement or other appropriate suit or administrative proceeding
as to such Competitive Infringement or to defend such Defense Action, such Party
does not take any action as described in Section 12.3.2(a) or Section 12.3.2(b)
and permitted hereunder against such Competitive Infringement or in defense of
such Defense Action, then the other Party may in its sole discretion, bring and
control any legal action in connection with such Competitive Infringement or
Defense Action at its sole expense, subject to the provisions of any applicable
In-License.

 

12.3.3.

Procedures; Expenses and Recoveries.  The Party having the right to initiate or
defend any suit, action or administrative proceeding to challenge any
Competitive Infringement or to defend a Defense Action under Section 12.3.2
shall have the sole and exclusive right to select counsel for any such suit,
action or proceeding and shall pay all expenses of the suit, action or
proceeding, including attorneys’ fees and court costs and reimbursement of the
other Party’s reasonable Out-of-Pocket Costs in rendering assistance requested
by the initiating or defending Party. If required under applicable Law in order
for the initiating or defending Party to initiate, defend or maintain such suit,
action or proceeding, or if either Party is unable to initiate, prosecute or
defend such suit, action or proceeding solely in its own name or it is otherwise
advisable to obtain an effective legal remedy, in each case, the other Party
shall join as a party to the suit, action or proceeding and will execute and
cause its Affiliates to execute all documents necessary for the initiating or
defending Party to initiate, maintain or defend such suit, action or proceeding.
In addition, at the initiating or defending Party’s request, the other Party
shall provide reasonable assistance to the initiating or defending Party in
connection with such suit, action or proceeding at no charge to the initiating
or defending Party except for reimbursement by the initiating or defending Party
of reasonable Out-of-Pocket Costs incurred in rendering such assistance. The
non-initiating or non-defending Party shall have the right to participate and be
represented in any such suit, action or proceeding by its own counsel at its own
expense. If the Parties obtain from a Third Party, in connection with such a
suit, action or proceeding, any damages, license fees, royalties or other
compensation (including any amount received in settlement of such litigation or
the applicable dispute), then such amounts shall be allocated in all cases as
follows:

 

(a)

first, to reimburse each Party for all expenses of the suit incurred by the
Parties, including attorneys’ fees and disbursements, court costs and other
litigation expenses;

 

(b)

second, [**] of the balance to be paid to Sarepta with respect to enforcement of
the Sarepta Technology in the Sarepta Territory or to Summit with respect to
enforcement of the Summit Technology in the Summit Territory; and

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(c)

third, [**] of the balance to be paid to the Party initiating the suit and [**]
of the balance to be paid to the other Party.

 

12.3.4.

Settlement. Neither Party will enter into any settlement of any an infringement
or other appropriate suit or administrative proceeding against a Competitive
Infringement or any Defense Action that could reasonably be expected to
materially adversely affect the other Party’s rights or interests without such
other Party’s written consent, which consent will not be unreasonably
withheld.  

12.4.

Patent Term Extensions.  Subject to the provisions of any Summit In-License,
Summit shall use Commercially Reasonable Efforts to obtain all available
supplementary protection certificates (“SPC”) and other extensions of Summit
Patent Rights in the Sarepta Territory. If more than one patent is eligible for
extension or patent term restoration in the Sarepta Territory, then the Parties
will use good faith efforts to mutually agree on a strategy with the goal of
maximizing patent protection and commercial value for the Licensed Product, and,
subject to the provisions of any Summit In-License, Summit will seek patent term
extensions, restorations and SPCs in accordance with that strategy.  Sarepta
will execute such authorizations and other documents and take such other actions
as may be reasonably requested by Summit to obtain any such extensions,
restorations and SPCs.

12.5.

Common Interest. All information exchanged between the Parties’ representatives
regarding the preparation, filing, prosecution, maintenance, enforcement or
defense of the Patents Rights under this Section 12 will be deemed Confidential
Information.  In addition, the Parties acknowledge and agree that, with regard
to such preparation, filing, prosecution, maintenance and enforcement of the
Patents Rights under this Section 12, the interests of the Parties as
collaborators and licensor and licensee are to obtain the strongest patent
protection possible, and as such, are aligned and are legal in nature.  The
Parties agree and acknowledge that they have not waived, and nothing in this
Agreement constitutes a waiver of, any legal privilege concerning the Patents
Rights under this Section 12, including privilege under the common interest
doctrine and similar or related doctrines.

12.6.

EU Unitary Patent System.  Without limitation of Sarepta’s rights under this
Section 12, Sarepta shall have the exclusive right to opt-in and opt-out the
Sarepta Patent Rights, Summit Patent Rights (subject to the provisions of any
Summit In-License) and Collaboration Patent Rights from the jurisdiction of the
E.U. Unified Patent Court, in accordance with Unified Patent Court (Regulation
(E.U.) No. 1257/2012) and its applicable Annexes and Rules of Procedure, as
amended and from time to time in effect, and Summit shall not do so.

12.7.

Third Party Infringement Claims.  If a Third Party sues a Party alleging that
the sued Party’s, or the sued Party’s Sublicensee’s, Development, Manufacture or
Commercialization of a Licensed Product infringes or will infringe said Third
Party’s intellectual property, then upon the sued Party’s request and in
connection with the sued Party’s defense of any such Third Party suit, the other
Party will provide reasonable assistance to the sued Party for such defense. The
sued Party will keep the other Party, if such other Party has not joined in such
suit, reasonably informed regarding such suit on a

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

quarterly basis, in person or by telephone, prior to and during the pendency of
any such suit.

12.8.

Trademarks.

 

12.8.1.

Use of Trademarks in Each Party’s Territory.  Each Party has the right to use
any trademark it owns or controls (other than by virtue of a license under this
Section 12.8) for Licensed Products in its Territory at its sole discretion, and
each Party and its Affiliates shall retain all rights, title and interests in
and to its and their respective corporate names and logos.

 

12.8.2.

Product Trademarks.  Sarepta will develop and propose, and the JSC shall review
and comment on, one or more Product Trademark(s) for use by Sarepta and its
Related Parties throughout the Sarepta Territory. Such Product Trademark(s)
considered by the JSC may include the Product Trademark(s) developed or used by
Summit with respect to the Commercialization of Licensed Products in the Summit
Territory (the “Summit Trademarks”). Any Product Trademark(s) (other than the
Summit Trademarks) that are used by Sarepta to Commercialize Licensed Products
in the Sarepta Territory are hereinafter referred to as the “Sarepta
Trademarks.” Summit (or its Related Parties, as appropriate) shall own all
rights to Summit Trademarks, and all goodwill associated therewith, throughout
the Summit Territory and the Sarepta Territory. Sarepta (or its Related Parties,
as appropriate) shall own all rights to Sarepta Trademarks and all goodwill
associated therewith, throughout the Sarepta Territory and Summit Territory.
Summit shall also own rights to any Internet domain names incorporating the
applicable Summit Trademarks or any variation or part of such Summit Trademarks
used as its URL address or any part of such address; and Sarepta shall also own
rights to any Internet domain names incorporating the applicable Sarepta
Trademarks or any variation or part of such Sarepta Trademarks used as its URL
address or any part of such address.

 

12.8.3.

Sarepta’s Use of Summit Trademarks.  If Sarepta or its Related Parties use any
Summit Trademarks to Commercialize any Licensed Product in the Sarepta
Territory, then the following provisions shall apply: Summit shall and hereby
does grant to Sarepta an exclusive royalty-free, fully paid-up, irrevocable,
perpetual license to use the applicable Summit Trademark(s) and the goodwill
associated therewith to Commercialize such Licensed Product in the Sarepta
Territory. Sarepta agrees that the quality of such Licensed Product and the
Manufacture and Commercialization thereof shall be consistent with the quality
standards applied by Summit thereto. In addition, Sarepta shall comply strictly
with Summit’s trademark style and usage standards that Summit provides to
Sarepta in writing from time to time with respect to the Summit Trademarks.
Sarepta shall at its own expense, at the request of Summit from time to time,
submit to Summit for approval a reasonable number of production samples of such
Licensed Product and related packaging materials. In the event that Summit
reasonably objects to the quality of such Licensed Product or the usage of the
Summit Trademarks in connection with any sample, it shall give written notice

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

of such objection to Sarepta within sixty (60) days of receipt by Summit of the
sample, specifying the way in which such usage of its Summit Trademarks fails to
meet the style, usage or quality standards for such Licensed Product set forth
in the first two sentences of this Section 12.8.3, and Sarepta shall immediately
cease sale and distribution of such Licensed Product. If Sarepta wishes to
continue to distribute and sell such Licensed Product, then it must remedy the
failure and submit further samples to Summit for approval.

 

12.8.4.

Summit’s Use of Sarepta Trademarks.  Neither Summit nor its Related Parties
shall use any Sarepta Trademarks to Commercialize any Licensed Product in the
Summit Territory; provided that, Sarepta does not adopt any Sarepta Trademark
that is confusingly similar to or incorporates any Summit Trademark.

 

12.8.5.

Maintenance and Enforcement.  If Summit Trademarks are used to Commercialize any
Licensed Product in the Sarepta Territory, then Summit will use Commercially
Reasonable Efforts to establish, maintain, enforce and defend such Summit
Trademarks in the applicable countries of the Sarepta Territory during the Term.
Sarepta shall be responsible for [**] of the costs of such efforts in the
Sarepta Territory and Sarepta shall reimburse Summit for all such costs incurred
by Summit within forty-five (45) days after receiving any invoice from Summit
for such costs. Sarepta will use Commercially Reasonable Efforts to establish,
maintain, enforce and defend any Sarepta Trademarks in the Sarepta Territory
during the Term, at its expense for so long as they are being used in connection
with Licensed Products.

 

12.8.6.

Product Trademark Infringement.  In the event either Party becomes aware of any
infringement of any Product Trademark by a Third Party, such Party shall
promptly notify the other Party and the Parties shall consult with each other
and jointly determine the best way to prevent such infringement, including by
the institution of legal proceedings against such Third Party.

 

12.8.7.

Use of Names.  For the avoidance of doubt, neither Party shall have any right to
use the other Party’s or the other Party’s Affiliates’ corporate names or logos
in connection with Commercialization of Licensed Products.

12.9.

Acknowledgment. It is the intention of the Parties that this Agreement is a
“joint research agreement” pursuant to Section 35 U.S.C. 102(c).

13.

TERM AND TERMINATION

13.1.

Term.  This Agreement shall be effective as of the Effective Date and, unless
terminated earlier pursuant to Section 13.2, this Agreement shall continue in
effect on a Licensed Product-by-Licensed Product and country-by-country basis
until expiration of the last Royalty Term to expire under this Agreement
(“Term”). Upon expiration of the Term, all licenses granted to Sarepta under
Section 7.1 then in effect shall become fully paid-up, perpetual, irrevocable
licenses and all licenses granted to Summit under Section 7.2 then in effect
shall become fully paid-up, perpetual, irrevocable licenses.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

13.2.

Termination Rights.

 

13.2.1.

Termination for Convenience.  

 

(a)

By Sarepta. Sarepta shall have the right to terminate this Agreement in its
entirety or on a Licensed Product-by-Licensed Product or country-by-country
basis at any time after the Effective Date on six (6) months’ prior written
notice to Summit.  If Sarepta terminates this Agreement with respect to one or
more, but not all, countries in the Sarepta Territory, then those countries will
cease being part of the Sarepta Territory commencing on the effective date of
such termination.  

 

(b)

Summit’s Resulting Right. If any termination by Sarepta pursuant to Section
13.2.1(a) prevents Sarepta from satisfying its obligations with respect to the
Terminated Licensed Product in the Major European Countries as set forth in
Sections 3.3 and 4.1.1, then such termination shall give Summit the right to
terminate this Agreement with respect to such Terminated Licensed Product as to
the EU by providing written notice to Sarepta within [**] of Summit’s receipt of
Sarepta’s notice of termination pursuant to Section 13.2.1(a). If any
termination by Sarepta pursuant to Section 13.2.1(a) prevents Sarepta from
satisfying its obligations with respect to the Terminated Licensed Product in
the Major Option Countries as set forth in Sections 3.3 and 4.1.1, then such
termination shall give Summit the right to terminate this Agreement with respect
to such Terminated Licensed Product as to the Option Territory by providing
written notice to Sarepta within [**] of Summit’s receipt of Sarepta’s notice of
termination pursuant to Section 13.2.1(a). The effects of such termination will
be as if Summit terminated this Agreement with respect to such Terminated
Licensed Product in the EU or the Option Territory, as applicable, pursuant to
Section  13.2.2.

 

13.2.2.

Termination for Cause.  This Agreement may be terminated, in its entirety or on
a Licensed Product-by-Licensed Product basis, at any time during the Term upon
written notice by either Party if the other Party is in material breach of its
obligations hereunder and has not cured such breach within [**] in the case of a
payment breach, or within [**] in the case of all other breaches, after notice
requesting cure of the breach; provided, however, that if any breach other than
a payment breach is not reasonably curable within [**] and if a Party is making
a bona fide effort to cure such breach, then such termination shall be delayed
for a time period to be agreed by both Parties, not to exceed an additional
[**], in order to permit such Party a reasonable period of time to cure such
breach.  For the avoidance of doubt, any failure by Sarepta to satisfy its
diligence obligations in Sections 2.4, 3.3 or 4.1.1 with respect to a Licensed
Product shall be deemed a material breach only with respect to such Licensed
Product for purposes of this Section 13.2.2.  If Sarepta fails to satisfy its
diligence obligations in Sections 3.3 or 4.1.1 as to a Licensed Product in the
Major European Countries or, if applicable, the Major Option Countries, then
Summit shall have the right to

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

terminate this Agreement as to such Licensed Product only in the EU or the
Option Territory, as applicable, as a result of such failure.  If Sarepta fails
to satisfy its diligence obligations in Sections 3.3 or 4.1.1 as to any country
in the Sarepta Territory outside the EU and the Option Territory, then Summit
shall have the right to terminate this Agreement as to such Licensed Product
only in such country as a result of such failure. If either Party initiates a
dispute resolution procedure in accordance with Section 14.3.2 to resolve a
dispute, claim or controversy regarding the material breach for which
termination is being sought and is diligently pursuing such procedure, then the
cure period set forth in this Section 13.2.2 will be tolled during the pendency
of such dispute resolution procedure.

 

13.2.3.

Termination for Safety Reasons.

 

(a)

Termination by Sarepta.  At any time during the [**] after the Effective Date,
Sarepta may terminate this Agreement with respect to the Benzoxazole Licensed
Product on not less than [**] prior written notice to Summit if Sarepta
reasonably determines based upon its review of the clinical data or upon a
determination by an applicable drug safety monitoring board or Governmental
Authority that the Benzoxazole Licensed Product caused or is likely to cause a
fatal, life-threatening or other Serious Adverse Event that is reasonably
expected, based upon then-available data, to preclude continued Development or
Commercialization of the Benzoxazole Licensed Product (such termination, a
“Safety Termination”).  Upon delivery of any such notice of a Safety
Termination, each Party may wind-down its then on-going activities related to
the Benzoxazole Licensed Product, including any on-going Clinical Studies, in
accordance with Section 13.3.2(c)(ii) (to the extent consistent with applicable
Laws).

 

(b)

Termination by Consensus. The Parties may terminate this Agreement on a Licensed
Product-by-Licensed Product basis prior to expiration of the [**] notice period
provided in Section 13.3.2(a) upon written agreement if the Parties: (i) reach
consensus that the Party proposing the Safety Termination is unable to continue
Developing or Commercializing a Licensed Product in the Field in its Territory;
and (ii) have completed all applicable wind-down and other transition
activities, including those set forth in Section 13.3.2(c)(ii).

 

13.2.4.

Challenges of Patent Rights.  In the event that Sarepta or any of its Related
Parties (a) commences or participates in any action or proceeding (including any
patent opposition or re-examination proceeding), or otherwise asserts any claim,
challenging or denying the validity or enforceability of any Summit Patent Right
or any claim thereof or (b) actively assists any other Person in bringing or
prosecuting any action or proceeding (including any patent opposition or
re-examination proceeding) challenging or denying the validity or enforceability
of any of such Summit Patent Rights or any claim thereof, then (i) Sarepta shall

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

give notice thereof to Summit within [**] of taking such action (or becoming
aware that its Related Party has taken such action) and (ii) Summit will have
the right, in its sole discretion to give notice to Sarepta that the licenses
granted to Sarepta with respect to all or any portion of the Summit Patent
Rights licensed to Sarepta under this Agreement will terminate [**] following
such notice (or such longer period as Summit may designate in such notice)
unless (x) Sarepta withdraws or causes to be withdrawn all such challenge or (y)
in the case of ex-parte proceedings, multi-party proceedings or other patent
challenges that Sarepta or Sarepta’s Related Parties do not have the power to
unilaterally withdraw or cause to be withdrawn, Sarepta and Sarepta’s Related
Parties cease assisting any other party to such patent challenge and, to the
extent Sarepta or a Sarepta Related Party is a party to such patent challenge,
it withdraws from such patent challenge, in each case, within such [**] period.
In the event that Summit is not permitted under Law to terminate the licenses
with respect to all Summit Patent Rights under this Agreement, then the Parties
agree to construe this provision to permit Summit to terminate only the licenses
to that portion of such Summit Patent Rights with respect to which Summit may
terminate consistent with applicable Law.  The foregoing shall not apply with
respect to (A) any patent challenge described in clause (a) or (b) above that is
made in defense of Summit’s assertion of any Summit Patent Right against Sarepta
or any of its Related Parties and (B) any patent challenge commenced by a Third
Party that after the Effective Date acquires or is acquired by Sarepta or its
Related Parties or its or their business or assets, whether by stock purchase,
merger, asset purchase or otherwise, provided that such patent challenge
commenced prior to the closing of such acquisition.

13.3.

Effect of Termination.

 

13.3.1.

Termination by Sarepta for Summit Breach.  Without limiting any other legal or
equitable remedies that either Party may have, if Sarepta has the right to
terminate this Agreement pursuant to Section 13.2.2 in its entirety or with
respect to a particular Licensed Product(s) (in the form such Licensed Product
exists as of the effective date of termination, a “Terminated Licensed
Product”), then Sarepta may elect, upon written notice to Summit, to either:

 

(a)

Termination. Terminate this Agreement in its entirety, in which case:

 

(i)

all license grants in this Agreement from either Party to the other shall
immediately terminate;

 

(ii)

Sarepta shall as promptly as practicable transfer to Summit or Summit’s designee
(x) possession and ownership of all governmental or regulatory correspondence,
conversation logs, filings and approvals (including all Regulatory Approvals and
pricing and reimbursement approvals) relating to the Development, Manufacture or
Commercialization of the Terminated Licensed Product and all Sarepta Trademarks
used

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

for the applicable Terminated Licensed Product(s) in the Field in the Sarepta
Territory (but not any Sarepta house marks or any trademark containing the word
“Sarepta” owned by Sarepta and used for the Terminated Licensed Products in the
Field in the Sarepta Territory), (y) copies of all data, reports, records and
materials, and other sales and marketing related information in Sarepta’s
possession or Control to the extent that such data, reports, records, materials
or other information relate to the Development, Manufacture or Commercialization
of the Terminated Licensed Product, including all non-clinical and clinical data
relating to the Terminated Licensed Product, and customer lists and customer
contact information and all adverse event data in Sarepta’s possession or
Control; provided that Sarepta shall use Commercially Reasonable Efforts to
obtain for Summit the right to access all such data, reports, records, materials
and other sales and marketing related information and (z) all records and
materials in Sarepta’s possession or Control containing Confidential Information
of Summit. Sarepta shall further appoint Summit as Sarepta’s or Sarepta’s
Related Parties’ agent for all Licensed Product-related matters involving
Regulatory Authorities in the Sarepta Territory until all Regulatory Approvals
and other regulatory filings have been transferred to Summit or its designee;
and

 

(iii)

Sarepta shall cease to have any financial obligations under this Agreement
(including obligations with respect to Development Costs pursuant to Section
2.2.3 or payments pursuant to Article 8); or

 

(b)

Payment Reduction. Maintain this Agreement in full force and effect (foregoing
the right to terminate this Agreement for such occurrence of such breach) and
all amounts set forth in Article 8 that are thereafter owed by Sarepta to Summit
shall be reduced by [**]. In addition to the reduction set forth in this Section
13.3.1(b), the consequences set forth in Section 13.4 shall also apply in the
circumstances set forth therein.

 

13.3.2.

Termination for Safety Reasons; Termination by Summit for Sarepta Breach or
Patent Challenge or by Sarepta for Convenience.  Without limiting any other
legal or equitable remedies that either Party may have, if this Agreement is
terminated, in its entirety or with respect to a Terminated Licensed Product, by
Sarepta under Section 13.2.1 or Section 13.2.3, or by Summit under Section
13.2.2, Section 13.2.3 or Section 13.2.4, then:

 

(a)

Milestone Payment.  Irrespective of the termination of this Agreement, Sarepta
shall make the non-refundable, non-creditable milestone payment to Summit set
forth in TABLE 8.2.1(i) no later than the later of (i) April 1, 2017 or (ii)
forty-five (45) days after the earliest date on

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

which such milestone event has first been achieved with respect to the first
Licensed Product to achieve such milestone event.

 

(b)

License Grant to Summit.  The license grants to Summit with respect to the
applicable Terminated Licensed Product(s) in Section 7.2 shall survive and shall
be expanded to include the Sarepta Territory (or if the Agreement was only
terminated with respect to some countries in the Sarepta Territory, those
terminated counties (the “Terminated Countries”)).

 

(c)

On-Going Clinical Trials.

 

(i)

Completion. Upon termination of this Agreement in its entirety or with respect
to a Licensed Product for any reason listed in this Section 13.3.2 other than
pursuant to Section 13.2.3, the Parties may complete any ongoing Clinical
Studies relating to the applicable Terminated Licensed Product(s) in the Sarepta
Territory. A Clinical Study will be considered “ongoing” if the first patient
visit in such Clinical Study had occurred but the last patient visit in such
Clinical Study and database lock had not yet occurred at the time notice of
termination was delivered.

 

(ii)

Wind-Down. Upon Summit’s receipt of notice of such termination of the Agreement
or the Parties’ agreement to terminate pursuant to Section 13.2.3, each Party
shall responsibly wind-down, in accordance with accepted pharmaceutical industry
norms and ethical practices, any on-going Clinical Studies of the applicable
Terminated Licensed Product(s).

 

(iii)

Responsibilities for Costs. Upon such termination, Sarepta shall reimburse
Summit for forty-five percent (45%) of Summit’s Out-of-Pocket Costs incurred
following the effective date of such termination in connection with the
completion of such ongoing Clinical Studies pursuant to Section 13.3.2(c)(i) or
the wind-down of such ongoing Clinical Studies pursuant to Section
13.3.2(c)(ii). Summit shall invoice Sarepta following the end of each Calendar
Quarter for such amounts due under this Section 13.3.2(c)(iii), and shall
provide supporting documentation as reasonably requested by Sarepta, and Sarepta
shall reimburse Summit for all such costs incurred by Summit within forty-five
(45) days after receiving any invoice from Summit for such costs. Sarepta shall
have the right to audit Summit’s records relating to such Out-of-Pocket Costs in
accordance with Section 8.5.

 

(d)

Transfer of Regulatory Materials. At Summit’s option, Sarepta shall as promptly
as practicable transfer to Summit or Summit’s designee (i) possession and
ownership of all governmental or regulatory

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

correspondence, conversation logs, filings and approvals (including all
Regulatory Approvals and pricing and reimbursement approvals) relating to the
Development, Manufacture or Commercialization of the applicable Terminated
Licensed Product(s) in the applicable Terminated Country(ies), (ii) copies of
all data, reports, records and materials and other sales and marketing related
information in Sarepta’s possession or Control to the extent that such data,
reports, records, materials or other information relate to the Development,
Manufacture or Commercialization of the applicable Terminated Licensed
Product(s) in the applicable Terminated Country(ies), including all non-clinical
and clinical data relating to the applicable Terminated Licensed Product(s), and
customer lists and customer contact information and all adverse event data in
Sarepta’s possession or Control relating to the applicable Terminated Licensed
Product(s); provided that Sarepta shall use Commercially Reasonable Efforts to
obtain for Summit the right to access all such data, reports, records, materials
and other sales and marketing related information and (iii) all records and
materials in Sarepta’s possession or Control containing Confidential Information
of Summit relating to the applicable Terminated Licensed Product(s) in the
applicable Terminated Country(ies). Sarepta shall further appoint Summit as
Sarepta’s or Sarepta’s Related Parties’ agent for all applicable Terminated
Licensed Product(s)-related matters involving Regulatory Authorities in the
Sarepta Territory (or the in the applicable Terminated Country(ies), if
applicable) until all applicable Regulatory Approvals and other regulatory
filings have been transferred to Summit or its designee.

 

(e)

Appointment as Distributor. Upon termination of this Agreement for any reason
listed in this Section 13.3.2 other than pursuant to Section 13.2.3, at Summit’s
option, if the effective date of termination is after First Commercial Sale,
then Sarepta shall appoint Summit as its exclusive distributor of the applicable
Terminated Licensed Product(s) in the Sarepta Territory (or the in the
applicable Terminated Country(ies), if applicable) and grant Summit the right to
appoint sub-distributors, until such time as all applicable Regulatory Approvals
in the Sarepta Territory (or the in the applicable Terminated Country(ies), if
applicable) have been transferred to Summit or its designee.

 

(f)

Third Party Agreements. Upon termination of this Agreement in its entirety or
with respect to a Licensed Product for any reason listed in this Section 13.3.2
other than pursuant to Section 13.2.3,  at Summit’s option, and to the extent
permitted under Sarepta’s obligations to Third Parties at the time of
termination, Sarepta shall transfer to Summit any Third Party agreements
relating solely and exclusively to the Development, Manufacture or
Commercialization of the applicable Terminated Licensed Product(s) to which
Sarepta is a party, subject to any required

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treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

consents of such Third Party, which Sarepta shall use Commercially Reasonable
Efforts to obtain promptly.

 

(g)

Trademark Assignment. At Summit’s option, Sarepta shall promptly transfer and
assign to Summit all of Sarepta’s and its Affiliates’ rights, title and
interests in and to the Sarepta Trademark(s) used for the applicable Terminated
Licensed Product(s) in the Field in the Sarepta Territory (but not any Sarepta
house marks or any trademark containing the word “Sarepta” owned by Sarepta and
used for the Terminated Licensed Products in the Field in the Sarepta
Territory);

 

(h)

Supply of Terminated Licensed Product.  At Summit’s option, Sarepta shall
transfer to Summit any inventory of the applicable Terminated Licensed
Product(s) Controlled by Sarepta or its Affiliates as of the termination date at
the actual price paid by Sarepta for such supply.

 

(i)

Further Assistance. Sarepta shall provide any other assistance reasonably
requested by Summit for the purpose of allowing Summit or its designee to
proceed expeditiously with the Development, Manufacture and Commercialization of
the applicable Terminated Licensed Product(s) in the Sarepta Territory. Sarepta
shall execute all documents and take all such further actions as may be
reasonably requested by Summit in order to give effect to the foregoing clauses.

13.4.

Breach of Summit’s Development Obligations for Next Generation Product.  Without
limiting Sarepta’s rights under Section 13.2.2 with respect to other material
breaches, if Summit abandons substantially all of the activities allocated to it
under the Development Plan with respect to the Next Generation Products, and
Sarepta does not terminate this Agreement in its entirety for cause pursuant to
Section 13.2.2, then, in addition to Sarepta’s remedies under Section 13.3.1(b),
then Sarepta may elect to assume Summit’s Development responsibilities under the
Collaboration with respect to such Next Generation Products, and if Sarepta does
so assume such responsibilities, Sarepta will be entitled to the following
remedies:

 

13.4.1.

Termination of Development Milestones. Sarepta’s obligation to pay then-unpaid
development milestone fees with respect to Next Generation Products under
Section 8.2 shall terminate.

 

13.4.2.

Tie Breaking Authority.  Notwithstanding Section 5.4.3, the Chief Executive
Officer of Sarepta or his or her designee shall have the deciding vote on any
matter involving the Development of the Next Generation Products.

13.5.

Effect of Expiration or Termination; Survival.  Expiration or termination of
this Agreement shall not relieve the Parties of any obligation accruing prior to
such expiration or termination; provided that, subject to Section 13.3.2(a),
Sarepta will have no obligation to pay any milestone payments that accrue under
Section 8.2 as a result of any milestone achieved thereunder following the date
on which any notice of termination of this

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Agreement is provided. Any expiration or termination of this Agreement shall be
without prejudice to the rights of either Party against the other accrued or
accruing under this Agreement prior to expiration or termination, including the
obligation to pay royalties for the Terminated Licensed Product sold prior to
such expiration or termination. The provisions of Sections 1, 7.6, 8.5, 8.6,
8.7, 8.8, 8.9, 9.1, 9.2.1, 10.4, 11, 12.1, 13.3, 13.4.2, 13.5 and 14 shall
survive any expiration or termination of this Agreement in accordance with their
terms. Except as otherwise set forth in this Section 13, upon termination or
expiration of this Agreement all rights and obligations of the Parties under
this Agreement shall cease.

14.

MISCELLANEOUS

14.1.

Standstill.  For the period beginning on the Effective Date and ending on the
date that Regulatory Approval is first received for a Licensed Product (the
“Standstill Period”), unless the other Party has specifically invited it to do
so in writing, neither Party nor any of its Affiliates or representatives acting
on behalf of and at the direction of such Party or any of its Affiliates
(collectively, the “Standstill Parties”) will in any manner, directly or
indirectly:  (a) effect or seek, offer or propose (whether publicly or
otherwise) to effect, or cause or participate in or assist or request any other
Person to effect or seek, offer or propose (whether public or otherwise) to
effect or participate in (i) any acquisition of any securities (or beneficial
ownership thereof) or assets of the other Party; (ii) any tender or exchange
offer, merger or other business combination involving the other Party; (iii) any
recapitalization, restructuring, liquidation, dissolution or other extraordinary
transaction with respect to the other Party; or (iv) any “solicitation” of
“proxies” (as such terms are used in the proxy rules of the SEC) or consents to
vote any voting securities of the other Party; (b) form, join or in any way
participate in a “group” (as defined under the Exchange Act) with respect to any
securities of the other Party; (c) Act in Concert with any person in relation to
voting securities of the other Party; (d) otherwise act, alone or in concert
with others, to seek to control or influence the management, Board of Directors
or policies of Summit, in each case, for the purpose of effecting a Change of
Control; (e) negotiate with or provide any information to any Third Party with
respect to, or make any statement or proposal to any Third Party with respect
to, or make any public announcement or proposal or offer whatsoever with respect
to, or act as a financing source for or otherwise invest in any other Third
Parties in connection with, or otherwise solicit, seek or offer to effect any
transactions or actions described, or take any action which would reasonably be
expected to obligate the other Party to make a public announcement regarding any
of the types of matters set forth in clause (a) above; or (f) enter into any
discussions or arrangements with any Third Party with respect to any of the
foregoing;  provided, however, [**].

14.2.

Assignment.  Except as provided in this Section 14.2, this Agreement may not be
assigned or otherwise transferred, nor may any right or obligation hereunder be
assigned or transferred, by either Party without the written consent of the
other Party. However, either Party may, without the other Party’s written
consent, assign this Agreement and its rights and obligations hereunder in whole
or in part to an Affiliate or to a party that acquires, by or otherwise in
connection with, merger, sale of assets or otherwise, all or substantially all
of the business of the assigning Party to which the subject matter of this
Agreement relates. The assigning Party shall remain responsible for the
performance by its assignee of this

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Agreement or any obligations hereunder so assigned.  Any purported assignment in
violation of this Section 14.2 shall be null, void and of no legal effect.

14.3.

Governing Law; Arbitration.  

 

14.3.1.

Governing Law. This Agreement shall be construed and the respective rights of
the Parties determined in accordance with the substantive Laws of the State of
New York, excluding any conflicts or choice of law rule or principle that might
otherwise refer construction or interpretation of this Agreement to the law of
another jurisdiction, and the patent Laws of the relevant jurisdiction without
reference to any rules of conflict of laws.

 

14.3.2.

Arbitration.  Any dispute arising out of or relating to this Agreement that has
not been resolved pursuant to Section 5.4 shall be resolved through binding
arbitration as follows:

 

(a)

A Party may submit such dispute to arbitration by notifying the other Party, in
writing, of such dispute.  Within thirty (30) days after receipt of such notice,
the Parties shall designate in writing a single arbitrator to resolve the
dispute; provided, however, that if the Parties cannot agree on an arbitrator
within such thirty (30)-day period, then the arbitrator shall be selected by the
Boston, Massachusetts office of the American Arbitration Association (the
“AAA”).  The arbitrator shall not be an Affiliate, employee, consultant,
officer, director or stockholder of any Party.

 

(b)

Within thirty (30) days after the designation of the arbitrator, the arbitrator
and the Parties shall meet, at which time the Parties shall be required to set
forth in writing all disputed issues and a proposed ruling on the merits of each
such issue.

 

(c)

The arbitrator shall set a date for a hearing, which shall be no later than
forty-five (45) days after the submission of written proposals pursuant to
Section 14.3.2(b), to discuss each of the issues identified by the Parties.  The
Parties shall have the right to be represented by counsel.  Except as provided
herein, the arbitration shall be governed by the Commercial Arbitration Rules of
the AAA; provided, however, that the Federal Rules of Evidence shall apply with
regard to the admissibility of evidence and the arbitration shall be conducted
by a single arbitrator.

 

(d)

The arbitrator shall use his or her best efforts to rule on each disputed issue
within thirty (30) days after the completion of the hearings described in
Section 14.3.2(c).  The determination of the arbitrator as to the resolution of
any dispute shall be binding and conclusive upon all Parties.  All rulings of
the arbitrator shall be in writing and shall be delivered to the Parties.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

(e)

The attorneys’ fees of the Parties in any arbitration, fees of the arbitrator,
and costs and expenses of the arbitration shall be borne by the Parties as
determined by the arbitrator.

 

(f)

Any arbitration pursuant to this Section 14.3.2 shall be conducted in Boston,
Massachusetts, U.S.  Any arbitration award may be entered in and enforced by any
court of competent jurisdiction.

 

(g)

Nothing in this Section 14.3.2 shall be construed as limiting in any way the
right of a Party to seek an injunction or other equitable relief with respect to
any actual or threatened breach of this Agreement or to bring an action in aid
of arbitration.  Should any Party seek an injunction or other equitable relief,
or bring an action in aid of arbitration, then for purposes of determining
whether to grant such injunction or other equitable relief, or whether to issue
any order in aid of arbitration, the dispute underlying the request for such
injunction or other equitable relief, or action in aid of arbitration, may be
heard by the court in which such action or proceeding is brought.

14.4.

Entire Agreement; Amendments.  This Agreement contains the entire understanding
of the Parties with respect to the subject matter hereof, and supersedes all
previous arrangements with respect to the subject matter hereof, whether written
or oral. This Agreement (including the Exhibits and Schedules hereto) may be
amended, or any term hereof modified, only by a written instrument duly-executed
by authorized representatives of both Parties.

14.5.

Severability.  If any provision hereof should be held invalid, illegal or
unenforceable in any respect in any jurisdiction, then the Parties shall
substitute, by mutual consent, valid provisions for such invalid, illegal or
unenforceable provisions, which valid provisions in their economic effect are
sufficiently similar to the invalid, illegal or unenforceable provisions that it
can be reasonably assumed that the Parties would have entered into this
Agreement with such valid provisions. In case such valid provisions cannot be
agreed upon, the invalid, illegal or unenforceable of one or several provisions
of this Agreement shall not affect the validity of this Agreement as a whole,
unless the invalid, illegal or unenforceable provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
Parties would not have entered into this Agreement without such invalid, illegal
or unenforceable provisions.

14.6.

Headings.  The captions to the Sections hereof are not a part of this Agreement,
but are merely for convenience to assist in locating and reading the several
Sections hereof.

14.7.

Waiver of Rule of Construction.  Each Party has had the opportunity to consult
with counsel in connection with the review, drafting and negotiation of this
Agreement. Accordingly, the rule of construction that any ambiguity in this
Agreement shall be construed against the drafting Party shall not apply.

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

14.8.

Interpretation.  Except where the context expressly requires otherwise, (a) the
use of any gender herein shall be deemed to encompass references to either or
both genders, and the use of the singular shall be deemed to include the plural
(and vice versa), (b) the words “include”, “includes” and “including” shall be
deemed to be followed by the phrase “without limitation”, (c) the word “will”
shall be construed to have the same meaning and effect as the word “shall,” (d)
any definition of or reference to any agreement, instrument or other document
herein shall be construed as referring to such agreement, instrument or other
document as from time to time amended, supplemented or otherwise modified
(subject to any restrictions on such amendments, supplements or modifications
set forth herein), (e) any reference herein to any Person shall be construed to
include the Person’s successors and permitted assigns, (f) the words “herein”,
“hereof” and “hereunder,” and words of similar import, shall be construed to
refer to this Agreement in its entirety and not to any particular provision
hereof, (g) all references herein to Sections, Exhibits or Schedules shall be
construed to refer to Sections, Exhibits or Schedules of this Agreement, and
references to this Agreement include all Exhibits and Schedules hereto, (h) the
word “notice” means notice in writing (whether or not specifically stated) and
shall include notices, consents, approvals and other written communications
contemplated under this Agreement, (i) provisions that require that a Party, the
Parties or any committee hereunder “agree,” “consent” or “approve” or the like
shall require that such agreement, consent or approval be specific and in
writing, whether by written agreement, letter, approved minutes or otherwise
(but excluding e-mail and instant messaging), (j) references to any specific
law, rule or regulation, or article, section or other division thereof, shall be
deemed to include the then-current amendments thereto or any replacement or
successor law, rule or regulation thereof and (k) the term “or” shall be
interpreted in the inclusive sense commonly associated with the term “or.”

14.9.

No Implied Waivers; Rights Cumulative.  No failure on the part of Summit or
Sarepta to exercise, and no delay in exercising, any right, power, remedy or
privilege under this Agreement, or provided by statute or at Law or in equity or
otherwise, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.

14.10.

Notices. All notices which are required or permitted hereunder shall be in
writing and sufficient if delivered personally, sent by email, sent by facsimile
(and promptly confirmed by personal delivery, registered or certified mail or
overnight courier), sent by nationally-recognized overnight courier or sent by
registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

If to Summit, to:

85b Park Drive

Milton Park, Abingdon

Oxfordshire, OX14 4RY

United Kingdom

Attention: Chief Executive Officer

Facsimile No.: +44 1235 443 999

 

With a copy to:

WilmerHale LLP

60 State Street

Boston, MA 02109

Attention: Steven D. Barrett, Esq.

Facsimile No.: (617) 526-5000

 

If to Sarepta, to:

Sarepta Therapeutics

215 First Street, Suite 415

Cambridge, MA 02142

Attention: General Counsel: Ty Howton

Email: thowton@sarepta.com

 

 

With a copy to:

Ropes & Gray LLP

Prudential Tower

800 Boylston Street

Boston, MA 02199-3600

Attention: David M. McIntosh

Facsimile No.: (617) 235-0507

 

or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such notice
shall be deemed to have been given: (a) when delivered if personally delivered
or sent by facsimile on a business day (or if delivered or sent on a
non-business day, then on the next business day); (b) on receipt if sent by
overnight courier or (c) on receipt if sent by mail.

14.11.

Compliance with Export Regulations.  Neither Party shall export any technology
licensed to it by the other Party under this Agreement except in compliance with
U.S. export Laws and regulations.

14.12.

Force Majeure.  Neither Party shall be held liable to the other Party nor be
deemed to have defaulted under or breached this Agreement for failure or delay
in performing any obligation under this Agreement to the extent that such
failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party, potentially including embargoes, war, acts of war
(whether war be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, fire, floods or other acts of
God. The affected Party shall notify the other Party of such force majeure
circumstances as soon as reasonably practical, and shall promptly undertake all
reasonable efforts necessary to cure such force majeure circumstances.

14.13.

Independent Contractors.  It is expressly agreed that Summit and Sarepta shall
be independent contractors and that the relationship between Summit and Sarepta
shall not constitute a partnership, joint venture or agency. Summit shall not
have the authority to make any statements, representations or commitments of any
kind, or to take any action, that would be binding on Sarepta, without the prior
written consent of Sarepta, and Sarepta

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

shall not have the authority to make any statements, representations or
commitments of any kind, or to take any action, that would be binding on Summit
without the prior written consent of Summit.

14.14.

Counterparts.  The Agreement may be executed in two or more counterparts,
including by facsimile or PDF signature pages, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.

14.15.

Binding Effect; No Third Party Beneficiaries. As of the Effective Date, this
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective permitted successors and permitted assigns. Except as expressly
set forth in this Agreement, no Person other than the Parties and their
respective Affiliates and permitted assignees hereunder shall be deemed an
intended beneficiary hereunder or have any right to enforce any obligation of
this Agreement.

[THE REMAINDER OF THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK]

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

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

SAREPTA THERAPEUTICS, INC.

SUMMIT (OXFORD) LTD

BY:/s/ Edward M. Kaye, M.D.

NAME: Edward M. Kaye, M.D.

TITLE: President and Chief Executive Officer

BY:/s/ Glyn O. Edwards

NAME: Glyn O. Edwards

TITLE: Chief Executive Officer

 

 

 

[Signature Page to License and Collaboration Agreement]

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

EXHIBIT A

INITIAL DEVELOPMENT PLAN

 

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

SCHEDULE 1.34

EXISTING SUMMIT IN-LICENSES

University of Oxford Option Agreement

 

 

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

Schedule 1.64

 

OPTION DATA PACKAGE

 

Clinical

 

1.

[**]

 

2.

[**]

 

3.

[**]

 

4.

[**]

 

5.

[**]

 

Preclinical

To the extent not previously provided to Sarepta:

 

1.

[**]

 

2.

[**]

 

3.

[**]

 

Manufacturing

To the extent not previously provided to Sarepta:

 

1.

[**]

 

2.

[**]

 

Other

 

1.

[**]

 

2.

[**]

 

3.

[**]  

 

 

 

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

SCHEDULE 1.89

SUMMIT PATENT RIGHTS

 

 

[**]

 

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

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

SCHEDULE 6.2

 

SUPPLY AGREEMENT TERMS

1.

Overview.  The Supply Agreements for a Collaboration Compound or Licensed
Product may, subject to the planned Development and Commercialization activities
of the Parties hereunder, provide for the Manufacture and supply of such product
in API Bulk Drug Substance, Bulk Drug Product or Finished Drug Product form
(each a “Product” and collectively “Products”) on commercially reasonable terms
customary to Third Party contract manufacturing organization supply agreements
for pharmaceuticals that are consistent with the principles set forth below.
Subject to the foregoing, Summit shall Manufacture and supply, either itself or
on a subcontracted basis through a Third Party manufacturer, and Sarepta shall
purchase from Summit its requirements of clinical supply of placebo and each
Product in accordance with the terms of the Clinical Supply Agreement (which
shall be consistent with the principles set forth in this Schedule 6.2). Subject
to the foregoing, Summit shall Manufacture and supply, either itself or on a
subcontracted basis through a Third Party manufacturer, commercial supply of
each Product in accordance with the terms of the Commercial Supply Agreement
(which shall be consistent with the principles set forth in this Schedule 6.2).

 

a.

“API Bulk Drug Substance” means a Collaboration Compound in bulk form
manufactured for use as an active pharmaceutical ingredient.

 

b.

“Bulk Drug Product” means formulated API Bulk Drug Substance, in bulk form prior
to filling and finishing.

 

c.

“Finished Drug Product” means the finished product formulation of a Licensed
Product, containing API Bulk Drug Substance, filled into unit packages for final
labeling and packaging, and as finally labeled and packaged in a form ready for
administration.

2.Supply of Product.

 

a.

Supply Obligation.  Summit will supply placebo and API Bulk Drug Substance, Bulk
Drug Product or Finished Drug Product, as applicable, in accordance with the
Supply Agreements to be negotiated by the Parties in accordance with Section 6.2
of the Agreement and consistent with the principles set forth in this
Schedule 6.2.  Sarepta will purchase such placebo and Product (in the product
form elected by Sarepta) exclusively from Summit or Summit’s subcontracted Third
Party manufacturer (and will not obtain or otherwise purchase from any others)
(i) unless a Third Party manufacturer has been established as a Second Source or
Back-Up Source for Manufacture of Product, in which case Sarepta will purchase
Licensed Product (in the Product form elected by Sarepta) from Summit or such
Third Party manufacturer or (ii) except as set forth in the applicable Supply
Agreement.

 

b.

Supply Price. Sarepta shall pay to Summit a per unit price with respect to
supply of placebo and Product “Supply Price,” which Supply Price will be
equivalent to the following:

 

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

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

i.

Product that Summit Does Not Manufacture Itself.  Any placebo or Product
manufactured by Summit’s Third Party manufacturers and supplied by Summit to
Sarepta will be supplied at a price equal to [**].

 

ii.

Product that Summit Manufactures Itself.  Any placebo or Product Manufactured by
Summit and supplied to Sarepta will be supplied at a price equal to [**].

 

e.

Specifications. The Supply Agreements will contain agreed written specifications
for the API Bulk Drug Substance, Bulk Drug Product and Finished Drug Product, as
applicable, and the Clinical Supply Agreement will contain specification for
placebo.

4.

Term and Termination. The term and termination provisions of each Supply
Agreement shall give due consideration to the term and termination provisions of
Summit’s agreements with its applicable Third Party manufacturers.

5.

Compliance, Warranties, Acceptance, Recalls, Indemnification and Limitations of
Liability.  The Supply Agreements will each contain terms and conditions
regarding compliance with Laws (including cGMPs and the Regulatory Approvals for
the applicable Product) and specifications for the applicable Product, delivery,
acceptance, recalls, indemnification and limitations of liability that are
customary in Third Party contract manufacturing agreements. Notwithstanding any
provision of this Schedule 6.2, Summit shall not have obligations under the
Clinical Supply Agreement with respect to a Collaboration Compound or Licensed
Product that are greater than the applicable Third Party manufacturer’s
obligations to Summit under the applicable agreement with such Third Party
manufacturer for such Collaboration Compound or Licensed Product.

6.

Shortages, Inventory.  The Supply Agreements will each provide that, in the
event Summit or its subcontracted Third Party manufacturer is unable to supply
placebo or a Product to meet the demand in the combined Summit Territory and
Sarepta Territory, then it will allocate placebo or such Product between the two
Territories equitably based on anticipated demand.

7.

Miscellaneous.  The Supply Agreements will each contain other customary terms
and provisions for agreements of their type as mutually agreed by the Parties.

 

 

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

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

Schedule 9.2.3

JOINT PRESS RELEASE

 

Sarepta Therapeutics and Summit Enter Into Exclusive License and Collaboration
Agreement for European Rights to Summit’s Utrophin Modulator Pipeline for the
Treatment of Duchenne Muscular Dystrophy

 

 

•

Sarepta and Summit collaborate to advance the development of novel therapies for
patients with Duchenne muscular dystrophy

 

•

Summit receives $40 million upfront, with potential future ezutromid-related
milestone payments totalling up to $522 million plus royalties

 

•

Sarepta and Summit to share research and development costs

 

•

Sarepta also receives option for Latin American rights

 

Cambridge, MA, and Oxford, UK, 4 October 2016 – Sarepta Therapeutics (NASDAQ:
SRPT) and Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that
they have entered into an exclusive license and collaboration agreement granting
Sarepta rights in Europe, as well as in Turkey and the Commonwealth of
Independent States (‘the licensed territory’), to Summit’s utrophin modulator
pipeline, including its lead clinical candidate, ezutromid, for the treatment of
Duchenne muscular dystrophy (‘DMD’). As part of the agreement, Sarepta also
obtains an option to license Latin American rights to Summit’s utrophin
modulator pipeline. Summit retains commercialization rights in all other
countries.

 

Utrophin modulation is a potential disease-modifying treatment for all patients
with the fatal muscle wasting disease DMD, regardless of their underlying
dystrophin gene mutation. Ezutromid is currently in a Phase 2 proof of concept
trial called PhaseOut DMD.

 

"This partnership with Summit Therapeutics furthers our commitment to invest in
innovative approaches to treating Duchenne and supports our common goal of
improving the lives of patients with DMD," said Edward Kaye, M.D., Sarepta’s
Chief Executive Officer. "Summit’s utrophin modulation technology represents a
potentially promising approach to treat DMD, which may complement our current
approach of exon skipping therapy.”

 

“Sarepta Therapeutics has paved the way in the development of disease-modifying
therapies for DMD with the first FDA-approved drug in this disease area, making
them a strong strategic partner to support our utrophin modulator pipeline,”
commented Glyn Edwards, Chief Executive Officer of Summit. “This agreement
provides us with access to Sarepta’s development, regulatory and
commercialisation expertise for the continued advancement of our promising
utrophin modulator pipeline. We look forward to this partnership and working
together to bring great advances to patients and families living with DMD.”

 

Under the terms of the agreement, Summit will receive an upfront fee of $40
million. In addition, Summit will be eligible for future ezutromid related
development, regulatory and sales milestone payments totalling up to $522
million, including a $22 million milestone upon the first dosing of the last
patient in Summit’s PhaseOut DMD trial, and escalating royalties ranging from a
low to high teens percentage of net sales in the licensed territory. Summit will
also be eligible to receive development and regulatory milestones related to its
next-generation utrophin modulators. Sarepta and Summit will share specified
utrophin modulator-related research and development costs at a 45%/55% split,
respectively, beginning in 2018. If Sarepta elects to exercise its option for
Latin American rights, Summit would be entitled to additional fees, milestones
and royalties.

 

Sarepta and Summit will host an update call for the Duchenne community on
Monday, October 10 at 12:00 EDT. Details of the call can be accessed by visiting
http://www.parentprojectmd.org/communitycall.  

 

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

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

 

This announcement contains inside information for the purposes of Article 7 of
EU Regulation 596/2014 (MAR).

 

About Utrophin Modulation in DMD

DMD is a progressive muscle wasting disease that is caused by different genetic
faults in the gene that encodes dystrophin, a protein that is essential for the
healthy function of all muscles. There is currently no cure for DMD and life
expectancy is into the late twenties. Utrophin protein is functionally and
structurally similar to dystrophin. In preclinical studies, the continued
expression of utrophin has a meaningful, positive effect on muscle performance.
Summit believes that utrophin modulation has the potential to treat all patients
with DMD, regardless of the underlying dystrophin gene mutation. Summit also
believes that utrophin modulation could potentially be complementary to other
therapeutic approaches for DMD. The Company’s lead utrophin modulator,
ezutromid, is an orally administered, small molecule. DMD is an orphan disease,
and the US Food and Drug Administration (‘FDA’) and the European Medicines
Agency have granted orphan drug status to ezutromid. Orphan drugs receive a
number of benefits including additional regulatory support and a period of
market exclusivity following approval. In addition, ezutromid has been granted
Fast Track designation and Rare Pediatric Disease designation by the FDA.

 

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and
commercialisation of novel medicines for indications for which there are no
existing or only inadequate therapies. Summit is conducting clinical programmes
focused on the genetic disease Duchenne muscular dystrophy and the infectious
disease C. difficile infection. Further information is available at
www.summitplc.com and Summit can be followed on Twitter (@summitplc).

 

About Sarepta

Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on
the discovery and development of unique RNA-targeted therapeutics for the
treatment of rare neuromuscular diseases. The Company is primarily focused on
rapidly advancing the development of its potentially disease-modifying DMD drug
candidates, including EXONDYS 51, designed to skip exon 51 and approved under
the accelerated approval pathway. For more information, please visit us at
www.sarepta.com.

 

Contacts

 

For Sarepta Therapeutics:

 

Sarepta

Ian Estepan   Tel: 617-274-4052

iestepan@sarepta.com

 

W2O Group

Brian Reid     Tel: 212-257-6725

breid@w2ogroup.com

 

For Summit:

 

Summit
Glyn Edwards / Richard Pye (UK office)

Erik Ostrowski / Michelle Avery (US office)

 

 

Tel: +44 (0)1235 443 951

       +1 617 225 4455

Cairn Financial Advisers LLP

(Nominated Adviser)

Liam Murray / Tony Rawlinson

 

 

 

Tel: +44 (0)20 77148 7900

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

N+1 Singer (Broker)

Aubrey Powell / Jen Boorer

 

 

Tel: +44 (0)20 7496 3000

MacDougall Biomedical Communications

(US media contact)

Chris Erdman / Karen Sharma

Tel: +1 781 235 3060

cerdman@macbiocom.com

ksharma@macbiocom.com

 

Consilium Strategic Communications
(Financial public relations, UK)

Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Lindsey Neville

 

Tel: +44 (0)20 3709 5700

Summit@consilium-comms.com

 

Sarepta Forward-looking Statements

This press release contains statements that are forward-looking. Any statements
contained in this press release that are not statements of historical fact may
be deemed to be forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential," "possible"
and similar expressions are intended to identify forward-looking statements.
These forward-looking statements include statements about the terms of the
license and collaboration agreement Sarepta has entered into with Summit
(Oxford) LTD, including the rights, obligations and benefits of each party under
the agreement such as Sarepta’s commercialization rights for certain product
candidates in specified territories and Sarepta’s payments associated with those
rights to Summit; the potential of ezutromid and utrophin modulation as a
disease-modifying treatment for all patients with DMD regardless of their
dystrophin gene mutation; the potential benefits to the parties and the DMD
community resulting from the agreement; the partnership between the parties
furthering their common goal of improving the lives of patients with DMD; the
potential of utrophin modulation technology to complement Sarepta’s current
approach of exon skipping therapy; Summit’s plans to access Sarepta’s expertise
for the continued advancement of their promising utrophin modulator pipeline and
working together to bring great advances to patients and families living with
DMD.

 

These forward-looking statements involve risks and uncertainties, many of which
are beyond Sarepta's control. Known risk factors include, among others: the
expected benefits and opportunities related to the license and collaboration and
agreement may not be realized or may take longer to realize than expected due to
challenges and uncertainties inherent in product research and development; the
partnership between Sarepta and Summit may not result in any viable treatments
suitable for clinical research or commercialization due to a variety of reasons
including the results of future research may not be consistent with past
positive results or may fail to meet regulatory approval requirements for the
safety and efficacy of product candidates or may never become commercialized
products due to other various reasons including any potential future inability
of the parties to fulfill their commitments and obligations under the agreement,
including any inability by Sarepta to fulfill its financial commitments to
Summit; and even if the agreement results in commercialized products the parties
may not achieve any significant revenues from the sale of such products.

 

Any of the foregoing risks could adversely affect Sarepta's business, results of
operations and the trading price of Sarepta's common stock. For a detailed
description of risks and uncertainties Sarepta faces, you are encouraged to
review Sarepta's 2015 Annual Report on Form 10-K and most recent Quarterly
Report on Form 10-Q for the quarter ended June 30, 2016 filed with the
Securities and Exchange Commission (SEC) as well as other SEC filings made by
Sarepta. We caution investors not to place considerable reliance on the
forward-looking statements contained in this press release. Sarepta does not
undertake any obligation to publicly update its forward-looking statements based
on events or circumstances after the date hereof.

 

Summit Forward-looking Statements

 

Any statements in this press release about Summit’s future expectations, plans
and prospects, including but not limited to, statements about the potential
benefits and future operation of the collaboration with Sarepta Therapeutics,
including any potential future payments thereunder, clinical and preclinical
development of Summit’s product candidates, the therapeutic potential of
Summit’s product candidates, and the timing of initiation, completion and
availability of data from clinical trials, and other statements

 

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

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.  An unredacted version of this exhibit has been filed
separately with the Commission.

 

containing the words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict," "project," "should,"
"target," "would," and similar expressions, constitute forward looking
statements within the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including:
the uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical trials and the
results of such trials, whether preliminary results from a clinical trial will
be predictive of the final results of that trial or whether results of early
clinical trials or preclinical studies will be indicative of the results of
later clinical trials, expectations for regulatory approvals, availability of
funding sufficient for Summit’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that Summit makes with the Securities and Exchange
Commission including Summit’s Annual Report on Form 20-F for the fiscal year
ended January 31, 2016. Accordingly readers should not place undue reliance on
forward-looking statements or information. In addition, any forward-looking
statements included in this press release represent Summit’s views only as of
the date of this release and should not be relied upon as representing Summit’s
views as of any subsequent date. Summit specifically disclaims any obligation to
update any forward-looking statements included in this press release.

 

 

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