Exhibit 10.8

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

ASSET PURCHASE AGREEMENT
by and between
Brickell Biotech, Inc.
as Purchaser,
and
Orca Pharmaceuticals LLC
and
Orca Pharmaceuticals Limited
as Sellers

Dated as of November 23, 2015

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ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT is made as of November 23, 2015 (“Effective Date”)
by and between Brickell Biotech, Inc., a Delaware corporation (“Purchaser”), and
Orca Pharmaceuticals LLC, a Delaware limited liability company (“Orca LLC”) and
Orca Pharmaceuticals Limited, a company incorporated and registered under the
laws of England and Wales (“Orca Ltd”), Orca LLC and Orca Ltd each known
individually as a “Seller” and collectively as “Sellers”.
RECITALS:
Subject to the terms and conditions set forth herein, Sellers desire to sell,
convey, transfer, assign and deliver to Purchaser, and Purchaser desires to
purchase and acquire from Sellers, all of Sellers’ and their Affiliates’ right,
title and interest in and to all of the Purchased Assets (the “Acquisition”).
Simultaneous with the execution of this Agreement, Orca LLC and Purchaser are
entering into [***].
NOW, THEREFORE, in consideration of the premises and for other good and valuable
consideration, the receipt and sufficiency of which are hereby expressly
acknowledged, the Parties, intending to be legally bound, hereby agree as
follows:
ARTICLE I

DEFINITIONS
1.1    Definitions. Unless otherwise defined herein, all capitalized terms shall
have the meaning set forth in the NYU License Agreement. As used herein, the
following terms shall have the following meanings:
“Acquisition” shall have the meaning given to such term in the Recitals.
“Affiliate” shall mean with respect to any Person, any other Person directly or
indirectly controlling, controlled by, or under common control with such Person;
provided, that, for purposes of this definition, “control” (including, with
correlative meanings, the terms “controlled by” and “under common control
with”), as used with respect to any Person, shall mean the possession, directly
or indirectly, of the power to direct or cause the direction of the management
and policies of such Person, whether through the ownership of voting securities
or by contract or otherwise.
“Agreement” shall mean this Asset Purchase Agreement.
“Assigned Know-How” shall mean (a) all information, data, results and analyses
of any research, preclinical, clinical, stability, toxicology or other study of
any Compound conducted by or on behalf of a Seller or its Affiliate, (b) all
manufacturing (including process development) data with respect to any Compound
generated by or on behalf of a Seller or its Affiliate, and (c) all other all
Know-How that is owned by a Seller or its Affiliate and relates to any Compound
or Product

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(which, for the avoidance of doubt, does not include NYU Know-How because that
is licensed to Orca LLC and not owned by either Seller), and (d) all patents and
patent applications (if any) that are owned by a Seller or its Affiliate and
relate to any Compound or Product.
“[***]” shall mean the [***] having such name and [***] Purchaser and Orca LLC
on the Effective Date.
“Assumed Liabilities” shall have the meaning given to such term in Section 2.2.
“Business Day” shall mean any day other than a Saturday, Sunday or a day on
which banks in Delaware are obligated by applicable Law or executive Order to
close or are otherwise generally closed.
“Calendar Quarter” means each period of three (3) months ending on March 31,
June 30, September 30 and December 31.
“Code” shall mean the Internal Revenue Code of 1986, as it may be amended from
time to time, and any successor thereto.
“Compound” shall mean: (a) any compound, the composition, manufacture or use of
which is claimed generically or specifically in any of the NYU/NIH Patents, and
(b) any and all pharmaceutically active derivatives of any compound described in
clause (a), including any prodrug, metabolite, ester, salt, hydrate, solvate,
polymorph, isomer or enantiomer thereof, and including compositions containing
such compound, prodrug or metabolites, or esters, salts, hydrates, solvates,
polymorphs, isomers or enantiomers of any compound described in clause (a).
“Confidential Information” shall have the meaning given to such term in Section
5.9.
“Confidentiality Agreement” shall mean the One-Way Confidentiality Agreement
dated June 22, 2015 entered into by Purchaser and Orca Ltd.
“Consent” means, with respect to any Person, any consent, approval,
authorization, permission or waiver of, or registration, declaration or other
action or filing with, or exemption by, such Person.
“Contract” means any contract, obligation, understanding, commitment, lease,
license, purchase order, bid or other agreement with outstanding rights or
obligations on the part of any party thereto, together with all amendments
thereto.
“Damages” means all damages, liabilities, losses, expenses, and fees, including
court costs and reasonable attorneys’, accountants’ and experts’ fees and
expenses.
“EMA” shall mean the European Medicines Agency or any successor agency thereto.
“Exception” shall have the meaning given to such term in Section 3.2.

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“FDA” shall mean the United States Food and Drug Administration or any successor
agency thereto.
“First Commercial Sale” shall mean, with respect to a Licensed Compound Product
in a country or other regulatory jurisdiction, the first sale of such Product
for end use or consumption in such country or jurisdiction after receipt of
Marketing Approval for such Licensed Compound Product in such country or
jurisdiction.
“Governmental Authorities” shall mean all agencies, authorities, bodies, boards,
commissions, courts, instrumentalities, legislatures and offices of any nature
whatsoever of any government or political subdivision, whether foreign, federal,
state, county, district, municipality, city or otherwise.
“Initiation” of a clinical trial shall mean first dosing of the first patient in
such clinical trial.
“Inventory” shall mean all inventory of the Compounds or Products in the
possession or control of a Seller or its Affiliate as of immediately prior to
the Effective Date.
“Know-How” means any and all information, know-how, data, results, knowledge,
techniques, discoveries, inventions, specifications, designs, regulatory
filings, trade secrets, technology, methods, processes, discoveries, inventions,
invention disclosures, developments, specifications, protocols, formulations,
formulae, software, algorithms, marketing reports, expertise, technology, test
data (including pharmacological, biological and chemical, biochemical,
preclinical test data, clinical test data and data resulting from non-clinical
studies), manufacturing processes, information, records, stability data and
other study data and procedures, business or financial information or
information of any type whatsoever, in any tangible or intangible form.
“Laws” shall mean any Federal, state, foreign or local statute, law, ordinance,
regulation, rule, code, Order, other requirement or rule of law.
“Liability” shall mean any direct or indirect indebtedness, liability,
assessment, expense, claim, loss, damage, deficiency, obligation or
responsibility, known or unknown, disputed or undisputed, joint or several,
vested or unvested, executory or not, fixed or unfixed, choate or inchoate,
liquidated or unliquidated, secured or unsecured, determinable or
undeterminable, accrued or unaccrued, absolute or not, actual or potential,
contingent or otherwise (including any liability under any guarantees, letters
of credit, performance credits or with respect to insurance loss accruals).
“Lien” means any lien, mortgage, pledge, encumbrance, charge, security interest,
adverse claim, liability, interest, charge, preference, priority, proxy,
transfer restriction (other than restrictions under federal or state securities
laws), encroachment, Tax, Order, community property interest, equitable
interest, option, warrant or right of first refusal.
“Marketing Approval” shall mean, with respect to any Licensed Compound Product
in a country or other regulatory jurisdiction, the approval by the applicable
Regulatory Authority in such country or jurisdiction of an NDA for such Licensed
Compound Product in such country or jurisdiction.

3

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“[***]” shall have the meaning given to such term in Section 2.4.
“[***]” shall have the meaning given to such term in Section 2.4.
“NDA” shall mean: (a) in the United States, a New Drug Application (as more
fully described in 21 CFR §314.50 et seq. or its successor regulation) filed
with the FDA, or any successor application thereto; (b) in the European Union, a
marketing authorization application filed with the EMA pursuant to the
centralized EMA filing procedure; or (c) in any other jurisdiction, an
application for Marketing Approval filed with the relevant Regulatory Authority
for such jurisdiction.
“NYU License Agreement” means the Second Restated License Agreement dated
November ___ 2015, by and between Orca LLC and New York University, a copy of
which is attached as Exhibit A, which is an amendment and restatement of the
Original License Agreement effective as of June 6, 2013, first amended and
restated as of January 28, 2015 (Restatement Agreement).
NYU Sublicense” shall have the meaning given to such term in Section 3.7.
“Order” shall mean any order, judgment, preliminary or permanent injunction,
temporary restraining order, award, citation, decree, consent decree or writ of
any Governmental Authority.
“Organizational Documents” means (a) any certificate or articles of
incorporation, bylaws, certificate or articles of formation or organization,
operating agreement or partnership agreement, (b) any documents comparable to
those described in clause (a) as may be applicable pursuant to any Law and (c)
any amendment or modification to any of the foregoing.
“Other NYU License” has the meaning given to such term in Section 3.7.
“Party” shall mean Sellers or Purchaser, individually, as the context so
requires, and the term “Parties” shall mean collectively, Sellers and Purchaser.
“Permit” means any approval, license, franchise, Consent, exemption, permit,
certificate, certificate of occupancy or Order issued by any Person.
“Person” shall mean an individual, corporation, partnership, limited
partnership, limited liability company, limited liability partnership,
syndicate, person (including a “person” as defined in Section 13(d)(3) of the
Securities Exchange Act of 1934, as amended, together with the rules and
regulations promulgated thereunder), trust, association, entity or government or
political subdivision, agency or instrumentality of a government.
“Phase 2 Trial” shall mean a human clinical trial that would satisfy the
requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or its
successor regulation), or any equivalent provision of the Laws of any relevant
jurisdiction.
“Phase 3 Trial” shall mean a human clinical trial that would satisfy the
requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) (or its
successor regulation) or any equivalent provision of the Laws of any relevant
jurisdiction.

4

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“Proceeding” means any claim, demand, dispute, action, audit, lawsuit,
litigation, investigation or arbitration (in each case, whether civil, criminal
or administrative) pending by or before any Governmental Authority or
arbitrator.
“Product” shall mean any product containing or comprising any Compound, whether
or not as the sole active ingredient, in any dosage, form or formulation.
“Purchase Price” shall have the meaning given to such term in Section 2.3.
“Purchased Assets” shall have the meaning given to such term in Section 2.1.
“Purchaser” shall have the meaning given to such term in the preamble of this
Agreement.
“Regulatory Authority” shall mean any regulatory agency, ministry, department or
other governmental body having authority in any country or region to control the
development, manufacture, marketing, and sale of pharmaceutical products,
including the FDA and EMA.
“SEC” shall mean the U.S. Securities and Exchange Commission.
“Selected Inventory” shall mean (a) that quantity of Compounds or Products from
the Inventory as set out in Exhibit B plus (b) any additional quantities of
Compounds or Products from the Inventory that Purchaser requests pursuant to
Section 5.5.
“Seller” shall have the meaning given to such term in the preamble of this
Agreement.
“Series 2 Compounds” shall mean the series of compounds generated solely by, or
on behalf of, Orca Ltd, which are covered by [***], as filed, together with any
structural derivatives of such compounds reduced to practice solely by Orca Ltd
or jointly by Orca Ltd and a Third Party.
“Sublicensee” shall mean a Third Party that has received (whether directly or
indirectly) a license or other right from Purchaser or its Affiliate to
research, develop manufacture, use, sell or otherwise commercialize any Licensed
Compound Product. For clarity, “Sublicensee” shall not include a Seller, an
Affiliate of a Seller or any Third Party that has received (whether directly or
indirectly) a license or other right from a Seller or its Affiliate to research,
develop, manufacture, use, sell or otherwise commercialize any Licensed Compound
Product.
“Tax Return” shall mean any return, report, statement, form or other
documentation (including any additional or supporting material and any
amendments or supplements) filed or maintained, or required to be filed or
maintained, with respect to or in connection with the calculation,
determination, assessment or collection of any Taxes.
“Taxes” shall mean: (i) any and all taxes, fees, levies, duties, tariffs,
imposts and other charges of any kind, imposed by any taxing authority,
including taxes or other charges on, measured by, or with respect to income,
franchise, windfall or other profits, gross receipts, property, sales, use,
capital stock, payroll, employment, social security, workers’ compensation,
unemployment compensation or net worth; taxes or other charges in the nature of
excise, withholding, ad valorem, stamp, transfer, value-added or gains taxes;
(ii) any Liability for the payment of any amounts of the

5

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type described in clause (i) as a result of being a member of an affiliated,
combined, consolidated or unitary group for any taxable period; (iii) any
Liability for the payment of amounts of the type described in clause (i) or
clause (ii) as a result of being a transferee of, or a successor in interest to,
any Person or as a result of an express or implied obligation to indemnify any
Person; and (iv) any and all interest, penalties, additions to tax and
additional amounts imposed in connection with or with respect to any amounts
described in clause (i), clause (ii) or clause (iii).
“Third Party” shall mean any Person other than Sellers or Purchaser or an
Affiliate of Sellers or Purchaser.
“Transaction Documents” shall mean, collectively, this Agreement and [***].
“US” means the United States of America, including its territories and
possessions.
1.2    Interpretation. Unless the context otherwise requires, the terms defined
in Section 1.1 shall have the meanings herein specified for all purposes of this
Agreement, applicable to both the singular and plural forms of any of the terms
defined herein. When a reference is made in this Agreement to Sections, such
reference shall be to a Section of this Agreement unless otherwise indicated.
Whenever the words “include,” “includes” or “including” are used in this
Agreement, they shall be deemed to be followed by the words “without
limitation.”
ARTICLE 2

PURCHASE & SALE OF PURCHASED ASSETS
2.1    Purchased Assets. Sellers hereby sell, convey, transfer, assign and
deliver to Purchaser, and Purchaser hereby purchases and acquires from Sellers,
free and clear of all Liens, all of Sellers’ and their Affiliates’ right, title
and interest in and to all of the following (collectively, the “Purchased
Assets”):
(a)    [***]
(b)    [***]
(c)    [***]
(d)    [***]
2.2    Assumed Liabilities. Except for the Assumed Liabilities, Purchaser shall
not, by virtue of its purchase of the Purchased Assets, assume or become
responsible for any Liabilities of either Seller or any other Person in
connection with this Agreement. Upon and subject to the terms, conditions,
representations and warranties of Sellers contained herein, Purchaser hereby
assumes and agrees to pay, perform, and discharge the following Liabilities: (a)
all Liabilities arising out of or relating to the ownership, operation,
maintenance, sale, lease or use by or on behalf of Purchaser or its Affiliates
or Sublicensees of the Assigned Know-How and Selected Inventory on or after the
Effective Date, (b) all Liabilities of Orca LLC under the NYU License Agreement
to the extent arising on or after the Effective Date, and (c) all Liabilities
for all research, development,

6

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manufacturing, registration, commercialization, use, handling, storage, sale,
offer for sale, import, export or other disposition or exploitation of Compounds
and Products by or on behalf of Purchaser or its Affiliates or Sublicensees on
or after the Effective Date (collectively, the “Assumed Liabilities”).
2.3    Purchase Price; Payment of Purchase Price. The aggregate consideration
for the sale of the Purchased Assets shall be: (a) [***] to be paid by Purchaser
to Orca LLC within thirty (30) days after the Effective Date, (b) the assumption
by Purchaser of [***] and (c) all [***] that become [***] pursuant to Sections
2.4 and 2.5, respectively (collectively, the “Purchase Price”).
2.4    [***] Payments. Within thirty (30) days after the [***] of each of the
events set forth in the table below (each, a “[***]”) by Purchaser or its
Affiliate or Sublicensee, Purchaser shall pay to Orca LLC [***] in the table
below (each such payment, a “[***]”).
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

Each [***] shall be payable only one time, regardless of the number of times the
[***]. Under no circumstances shall Purchaser be obligated to pay to Orca LLC
more than [***] pursuant to this Section 2.4.
2.5    [***] Payments.
(a)    [***] Purchaser will pay [***] to Orca LLC equal to [***] by Purchaser
and its Affiliates and Sublicensees (“[***]”). [***] shall be payable [***].
(b)    Reports. Within sixty (60) days after the end of each Calendar Quarter
during [***], Purchaser shall deliver to Sellers a written report [***] due
under Section 2.5(a), in sufficient detail to permit confirmation of the
accuracy of [***] due to Orca LLC for any Calendar Quarter shall be paid no
later than the date the written report for such calendar quarter is due.
2.6    Payments; Audits.
(a)    Exchange Rate; Manner and Place of Payment. All payments hereunder shall
be payable in [***]. Whenever conversion of amounts paid or reported to
Purchaser or any of its Affiliates any foreign currency to US dollars is
required, such conversion shall be made into US dollars based on the closing
buying rate listed at www.oanda.com for the particular currency on the last
business day of the Calendar Quarter for which such royalty is due. All payments
owed by Purchaser under this Agreement shall be made by wire transfer to a bank
and account designated in writing by Orca LLC, unless otherwise specified in
writing by Orca LLC. Purchaser shall be responsible for payment to Orca LLC of
all royalties due on sale, transfer or disposal of Licensed Compound Products by
Affiliates of Purchaser.

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(b)    Interest payments. Any amount due by Purchaser to Orca LLC which has not
been paid by the date on which such payment is due, shall bear interest from
such date until the date on which such payment is made, at the rate of [***] (%)
per annum in excess of the prime rate prevailing at the Citibank, N.A. in New
York, during the period of arrears.
(c)    Audits. Until the expiration of [***] hereunder and for a period of three
(3) years thereafter, Purchaser shall keep complete and accurate records
pertaining to the sale, transfer or other disposition of Licensed Compound
Products for consideration by Purchaser and its Affiliates and Sublicensees, in
sufficient detail to permit Sellers to [***] hereunder. Seller shall have the
right to cause an independent, nationally recognized, certified public
accountant reasonably acceptable to Purchaser to audit such records to [***],
for a period covering not more than the preceding three (3) calendar years.
Purchaser may require such accountant to execute a reasonable confidentiality
agreement with Purchaser prior to commencing the audit. Such audits may be
conducted during normal business hours upon reasonable prior written notice to
Purchaser, but no more than frequently than once per year. No accounting period
of Purchaser shall be subject to audit more than one time by Sellers. Prompt
adjustments (including remittances of underpayments or overpayments disclosed by
such audit) shall be made by the parties to reflect the results of such audit.
Sellers shall bear the full cost of such audit unless such audit discloses an
underpayment by Purchaser of [***] of the amounts due under this Agreement and
such [***], in which case Purchaser shall bear the full cost of such audit.
2.7    Allocation of Purchase Price. Purchaser and Sellers shall cooperate in
good faith to agree as to the allocation of the Purchase Price pursuant to
Section 1060 of the Code and the treasury regulations promulgated thereunder.
The Parties hereto further agree that: (a) the agreed upon allocation of
Purchase Price shall be used in filing all required forms under Section 1060 of
the Code and all Tax Returns; and (b) they will not take any position
inconsistent with such allocation upon any examination of any such Tax Return,
in any refund claim or in any tax litigation.
2.8    Transfer Taxes. Purchaser shall be responsible for the payment of any
sales, use, transfer or similar taxes arising out of or in connection with the
Acquisition; provided that Orca LLC shall [***] promptly following written
request from Purchaser, including documentation of any such payments.
2.9    Withholding. All payments made by the Purchaser under this Agreement
shall be made without withholding or deduction of, or in respect of, any Tax
unless required by Law. If a Law requires Purchaser to withhold or deduct Taxes
of any type from payments payable hereunder to Orca LLC, Purchaser shall (a)
deduct such Tax from the payment made to Orca LLC, (b) timely pay such Taxes for
and on behalf of Orca LLC to the proper Government Authority, and (c) furnish
Orca LLC with documentation of such payment within thirty (30) days following
such payment.
ARTICLE 3

REPRESENTATIONS AND WARRANTIES OF SELLERS
Sellers represent and warrant to Purchaser that the statements contained in this
Article 3 are true and correct as of the Effective Date.

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3.1    Organization and Qualification. Orca LLC is a limited liability company
duly organized, validly existing and in good standing under the laws of the
State of Delaware. Orca Ltd is a limited liability company duly organized,
validly existing and in good standing under the laws of England and Wales. Each
of the Sellers has the requisite power to own and operate the Purchased Assets
and carry on its business as now being conducted.
3.2    Authority Relative to this Agreement. Sellers have all requisite power
and authority to execute and deliver this Agreement and the other Transaction
Documents, to perform their obligations hereunder and to consummate the
Acquisition. The execution, delivery and performance of this Agreement and the
other Transaction Documents by Sellers and the consummation by Sellers of the
Acquisition have been duly and validly authorized by all necessary action of the
Sellers, and no other action on the part of either Seller is necessary to
authorize this Agreement and the other Transaction Documents or to consummate
the Acquisition. This Agreement and the other Transaction Documents have been
duly executed and delivered by Sellers and, assuming the due authorization,
execution and delivery by the other Party hereto, each such agreement
constitutes a legal, valid and binding obligation of each Seller, enforceable
against each Seller in accordance with its terms, subject to the effect of any
applicable bankruptcy, moratorium, insolvency, reorganization or other similar
law affecting the enforceability of creditors’ rights generally and to the
effect of general principles of equity which may limit the availability of
remedies, whether in a proceeding at Law or in equity (collectively, the
“Exception”).
3.3    No Conflict. The execution and delivery of this Agreement and the other
Transaction Documents by Sellers do not, and the performance by Sellers of their
obligations hereunder and the consummation of the Acquisition and the
transactions contemplated by the other Transaction Documents will not: (a)
violate or conflict with any Law or Order to which either Seller is subject, (b)
violate or conflict with any provision of the Organizational Documents of either
Seller, or (c) conflict with, result in a breach of, constitute a default under,
result in the acceleration of, create in any party the right to accelerate,
terminate, modify, or cancel, or require any notice, Consent or payment under,
any Contract, Permit, instrument, or other arrangement included in the Purchased
Assets to which a Seller is a party or by which a Seller is bound or to which
any of the Purchased Assets is subject (or result in the imposition of any Lien
upon any of the Purchased Assets). Neither Seller is required to give any notice
to, make any filing with, or obtain any Consent or Permit of any Governmental
Authority or other Person in order to consummate the transactions contemplated
by this Agreement or the Transaction Documents.
3.4    Brokers’ Fees. Neither Seller is a party to any Contract as a result of
which a broker, finder or agent could hold any payment obligation against
Purchaser with respect to the transactions contemplated by this Agreement.
3.5    No Liens. Each of the Sellers has good and marketable title to the
Purchased Assets, free and clear of all payment obligations, other Liens, Orders
or limitations or restrictions on their use.
3.6    Effect of Transaction. Sellers have the right to assign their and their
Affiliates’ right, title and interest in the Purchased Assets to Purchaser as
set forth in this Agreement. Neither the execution, delivery or performance of
the Agreement nor the consummation of the transactions

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contemplated hereby will: (a) cause the grant, assignment or transfer to any
Person (other than Purchaser) of any license or other right or interest under,
to or in any of the Purchased Assets; or (b) conflict with, result in a breach
of, constitute a default under, result in the acceleration of, create in any
party the right to accelerate, terminate, modify, or cancel, or require any
notice, Consent or payment under any Contract, Permit, instrument, or other
arrangement to which any of the Purchased Assets is subject (or result in the
imposition of any Lien upon any of the Purchased Assets, including Orca LLC’s
rights pursuant to [***]).
3.7    [***] License Agreement. Orca LLC is party to [***] and has not assigned,
transferred, licensed, sublicensed, granted any options to or pledged any of its
rights or obligations thereunder to any Third Party. Orca LLC has not assigned,
transferred, licensed, sublicensed, granted any options to or pledged any of its
rights or obligations thereunder to any of its Affiliates other than [***] to
Orca Ltd (such sublicense, the “NYU Sublicense”). Orca LLC complied with all
obligations set forth in Section 5.06 of the 10 NYU License Agreement with
respect to the NYU Sublicense. The NYU Sublicense did not permit Orca Ltd to,
nor did Orca Ltd, assign, transfer, license, sublicense, grant any options to or
pledge any of its rights or obligations thereunder to any Person. The NYU
Sublicense was terminated in full prior to the Effective Date, without Orca Ltd
retaining any post-termination rights under the NYU License Agreement or to any
NYU/NIH Patents, NYU Patents or NYU Know-How other than Orca Ltd’s separate
sublicense under Orca LLC’s non-exclusive license to the NYU Know-How pursuant
to a license agreement dated January 28, 2015 between NYU and Orca LLC that is
not the NYU License Agreement (such license agreement, the “Other NYU License”).
Sellers have delivered or has made available to Purchaser a correct and complete
copy of (a) the NYU License Agreement, together with all amendments, exhibits,
attachments, waivers or other changes thereto and (b) the NYU Sublicense,
together with all amendments, exhibits, attachments, waivers or other changes
thereto, including with respect to the termination thereof. Subject to the
Exception, the NYU License Agreement is legal, valid, binding, enforceable, in
full force and effect. The NYU License Agreement has not been breached or
cancelled by either Seller, or to the knowledge of Sellers, by any other party
thereto. Orca LLC has not irrevocably waived any of its rights under the NYU
License Agreement. Orca LLC or Orca Ltd has performed all obligations under the
NYU License Agreement that are required to be performed by Orca LLC or Orca Ltd.
To the knowledge of Sellers, there is no event which, upon giving of notice or
lapse of time or both, would constitute a breach or default under the NYU
License Agreement or would permit the termination, modification or acceleration
of the NYU License Agreement.
3.8    Assigned Know-How. Orca Ltd is the sole and exclusive owner of the
Assigned Know-How. Orca Ltd has not granted to any Person any license of, option
to obtain a license of, or other right with respect to, any Assigned Know-How.
There are no pending Proceedings or Orders, and to Sellers’ knowledge, no
Proceedings or Orders threatened in writing in any jurisdiction or territory,
between a Seller and any Third Party relating to the Assigned Know-How. To the
knowledge of Sellers, the creation of the Assigned Know-How did not violate,
infringe, misappropriate or unlawfully use, or constitute any contributory
infringement of or inducement to infringe, misappropriate or unlawfully use, any
patent, Know-How, trademark, copyright or application therefor of any Person.

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3.9    Inventory. Exhibit B provides an accurate and complete breakdown of all
Inventory as of November __, 2015 of the Compounds specifically identified in
Exhibit B. All of the Inventory: (a) is of such quality and quantity as to be
usable by Purchaser in the ordinary course of business; and (b) is free of any
defect or deficiency to the knowledge of Sellers.
3.10    Sufficiency. Except for the Inventory not included in the Selected
Inventory as of the Effective Date, the Purchased Assets constitute all of the
rights, property and assets that are owned by either Seller or any of its
Affiliates as of the Effective Date and that are necessary or reasonably useful
for the research, development or commercialization of any Compound or Product.
3.11    [***]
3.12    No Patents. Sellers and their Affiliates do not own any patents or
patent applications that disclose or claim the composition of matter,
manufacture or use of any Compound or Product.
3.13    License or Option Agreements. Except pursuant to the NYU License
Agreement, no Seller or Affiliate of a Seller has obtained any license, option
to obtain license, or right to use, any patent, Know-How, trademark, copyright
or application therefor that is related to any Compound or Product or the
development, manufacture, use, offer for sale or sale thereof.
3.14    Contracts. Except for the NYU License Agreement, [***] (including the
research, development, manufacture, transport, distribution, marketing, use,
offer for sale, or sale thereof).
3.15    Litigation. There are no pending, and to the knowledge of Seller, no
threatened, adverse actions, claims, investigations, suits or proceedings
against a Seller or any of its Affiliates, at Law or in equity, or before or by
any Governmental Authority, involving the Purchased Assets or any Compound or
Product.
3.16    Other Compounds. Other than the Compounds and the Series 2 Compounds, no
Seller and no Affiliate of a Seller possesses any right, title, license, option
or other interest in or to any compound or other molecule that was developed or
arose through the use of the NYU Know-How or that [***]
3.17    [***] and its Affiliates do not have any rights (including any licenses
or options to obtain a license) to any Compounds or Products or to any NYU/NIH
Patents. No Seller or Affiliate of a Seller has any obligations to [***] or its
Affiliates that prohibit or place any limitations on a Seller’s or its
Affiliate’s ability to research, develop, manufacture or commercialize any
Compounds or Products or to enable or grant rights to others to do so.
ARTICLE 4

REPRESENTATIONS AND WARRANTIES OF PURCHASER
Purchaser represents and warrants to Sellers, that each of the following
representations and warranties is true and correct as of the Effective Date:

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4.1    Organization and Qualification. Purchaser is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Delaware and has all requisite power and authority and all necessary
governmental approvals to own, lease and operate its properties and to carry on
its business as now being conducted.
4.2    Authority Relative to this Agreement. Purchaser has all necessary power
and authority to execute and deliver this Agreement and the other Transaction
Documents to which it is a party, to perform its obligations hereunder and to
consummate the Acquisition. The execution and delivery of this Agreement and the
other Transaction Documents by Purchaser and the consummation by Purchaser of
the Acquisition have been duly and validly authorized by all necessary action of
the Purchaser and its board of directors, and no other proceedings on the part
of Purchaser are necessary to authorize this Agreement or to consummate the
Acquisition. This Agreement and the other Transaction Documents have been or
when executed and delivered will be duly executed and delivered by Purchaser
and, assuming the due authorization, execution and delivery by the other Parties
hereto, each such agreement constitutes a legal, valid and binding obligation of
Purchaser, enforceable against Purchaser in accordance with its terms, subject
to the Exception.
4.3    No Conflict. The execution and delivery of this Agreement by Purchaser do
not, and the performance by Purchaser of its obligations hereunder and the
consummation of the Acquisition will not: (a) conflict with or violate any
provision of the Organizational Documents of Purchaser or (b) conflict with or
violate any Law or Order applicable to Purchaser or by which Purchaser is bound
or affected. Purchaser is not required to give any notice to, make any filing
with, or obtain any Consent or Permit of any Governmental Authority or other
Person in order to consummate the transactions contemplated by this Agreement.
4.4    Brokers’ Fees. Purchaser is not party to any Contract as a result of
which a broker, finder or agent could hold any payment obligation against
Sellers with respect to the transactions contemplated by this Agreement.
4.5    Litigation. The Purchaser is not party to any Proceedings pending or, to
Purchaser’s knowledge, threatened in writing by a Third Party challenging, or
that would have the effect of preventing, delaying, making illegal or otherwise
interfering with, the transactions contemplated hereby.
ARTICLE 5

ADDITIONAL COVENANTS
5.1    Further Assurances. Sellers hereby agree, without further consideration,
to execute and deliver following the Effective Date such other instruments of
transfer and take such other action as Purchaser (or Purchaser’s counsel on
behalf of Purchaser) may reasonably request in order to [***] in accordance with
this Agreement. To the extent that Purchaser is required to make any filing with
the SEC that includes financial statements under Regulation S-X with respect to
[***], Sellers shall reasonably cooperate with Purchaser in the preparation of
any such SEC-required financial statements (including pro forma financials).

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5.2    Technology Transfer. Promptly after the Effective Date, Seller shall
transfer to Purchaser [***].
5.3    Development and Commercialization by Purchaser.
(a)    Purchaser shall provide to Sellers a copy of the current Development Plan
within thirty (30) days following the Effective Date, and shall promptly (and in
any event within thirty (30) days) provide to Seller all amendments to the
Development Plan that are agreed between Purchaser and New York University
during the term of the NYU License Agreement.
(b)    Purchaser shall provide to Sellers copies of all the written reports on
all activities and actions undertaken by Purchaser to develop and commercialise
the Licensed Products as provided to New York University pursuant to Section
8.04 of the NYU License Agreement, at the same time that Purchaser provides such
reports to New York University, pursuant to the aforesaid Section 8.04.
5.4    Transfer of Purchased Assets. Sellers shall transfer and deliver to
Purchaser all Assigned Know-How and Selected Inventory within thirty (30)
calendar days of the Effective Date, at Purchaser’s expense for shipping and
handling costs, to the locations, and in accordance with the instructions,
specified by Purchaser. Sellers will, to the extent any such Assigned Know-How
exists in a form suitable for electronic transfer, make such transfer to
Purchaser electronically.
5.5    Request of Inventory. At any time during the first twelve (12) months
following the Effective Date (the “First Year”), Purchaser shall have the right
to request the transfer by Sellers of further Compounds and/or Products from the
Inventory, at Purchaser’s expense for shipping and handling costs, to the
locations, and in accordance with the instructions, specified by Purchaser.
Sellers shall provide such further Compounds and/or Products within thirty (30)
days of such request.
5.6    Grant of Rights to Orca Ltd.
(a)    Purchaser hereby grants to Orca Ltd a [***] (as defined below), to
perform [***] during the First Year directly relating to (a) [***] of one or
more Compounds for [***]; and/or (b) use of one or more Compounds that [***]
((a) and (b) collectively, the “[***]”); provided that Orca Ltd shall not
perform any research on any Compound that Purchaser identifies in writing to
Orca Ltd as a lead compound or a candidate therefor. In the event that Orca Ltd
undertakes any such internal research, Orca Ltd shall promptly disclose to
Purchaser any and all intellectual property (including patentable inventions),
Know-How, data and results generated through the conduct of such research
(collectively, the “Research Results”), and Sellers shall and hereby do assign
to Purchaser all right, title and interest in and to the Research Results,
including the sole right to apply for any patents and patent applications that
disclose or claim any inventions included in the Research Results (the “Research
Patents”). At Purchaser’s reasonable request and expense, Sellers shall, and
shall ensure that their employees and consultants, take all actions necessary or
useful to demonstrate or perfect Purchaser’s ownership of the Research Results
and Research Patents or to facilitate the filing, prosecution, maintenance,
defense or enforcement of any Research Patent. The foregoing license under the
Licensed Technology is a sublicense under the License granted pursuant to the
NYU License Agreement and Purchaser is required upon granting such a sublicense
to impose

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certain obligations on the sublicensee. Accordingly, the Parties agree to the
provisions set forth in Exhibit E.
(b)    At Orca Ltd’s written request any time [***], or within 30 days after
[***] Orca Ltd pursuant to sub-section 5.6(a) above, whichever is earlier
(“[***]”), the Parties will negotiate in good faith to agree upon the terms and
conditions of, and upon agreement upon such terms and conditions, promptly enter
into an agreement pursuant to which Purchaser will grant to Seller [***], which
terms and conditions will include the terms and conditions set forth in [***]
and additional, mutually agreed terms and conditions (“[***]”). If the Purchaser
and Orca Ltd do not enter into [***] prior to [***], Purchaser shall not have
any obligations to Orca Ltd, and Orca Ltd. shall not have any rights, with
respect to [***] provided, however, that the foregoing shall not be interpreted
as depriving Orca Ltd to any rights it may have to the NYU Know-How as a result
of a sublicense from Orca LLC under the Other NYU License.
5.7    Bulk Sales. Each of the Parties hereby waives compliance with the
notification and all other requirements of the bulk sales laws in force in the
jurisdiction in which such laws are applicable to the Purchased Assets or the
transactions contemplated by this Agreement.
5.8    Press Releases and Public Announcements. Purchaser may issue a press
release announcing this Agreement promptly after the Effective Date, subject to
the mutual agreement by the Parties of the content and form of such press
release. Except for such press release, and except as set forth in Section 5.9,
no Party shall issue any press release or make any public announcement related
to the subject matter of this Agreement without the prior consent of the other
Party; provided, that nothing in this Section 5.8 shall prevent any Party from:
(a) making any disclosure it believes in good faith it is required to make by
applicable Law or any listing or trading agreement concerning its securities (in
which case the disclosing Party shall use its reasonable best efforts to advise
the other Party prior to making the disclosure) or (b) enforcing its rights
hereunder.
5.9    Confidentiality.
(a)    Each Party shall hold, and shall use commercially reasonable efforts to
cause its representatives (which, for the purposes of this Section 5.9 shall
include such Party’s: (i) Affiliates, (ii) underwriters or initial purchasers in
connection with their due diligence for securities offerings of such Party,
(iii) potential investors or other financing sources in connection with their
due diligence for financings of such Party, or (iv) potential acquirers of such
Party, in each case, so long as they are otherwise subject to similar
confidentiality obligations to such Party) to hold, in strict confidence from
any Person (other than any such representative), and shall not use for any
purpose, the terms and conditions of this Agreement and all non-public documents
and information furnished to it or its Affiliates by or on behalf of the other
Party or its Affiliates under this Agreement or the Confidentiality Agreement
(“Confidential Information”), except to the extent necessary to perform its
obligations or to exercise its rights under this Agreement or as otherwise
expressly authorized by this Agreement (which in the case of the representatives
described in the parenthetical above, shall include the right to disclose or use
for due diligence and transactions described therein) or otherwise agreed in
writing by the Parties. For clarity, all non-public information included in the
Purchased Assets shall be deemed Confidential Information of Purchaser, and
Sellers shall be deemed the receiving Party of such Confidential Information.

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(b)    The foregoing confidentiality and non-use obligations shall not apply to
any information that can be shown by the receiving Party to have been: (i)
previously known by the receiving Party (excluding information included in the
Purchased Assets); (ii) in the public domain (either prior to or after the
furnishing of such documents or information hereunder) other than through the
receiving Party’s breach of its confidentiality obligations hereunder; or (iii)
lawfully acquired by the receiving Party or any of their Affiliates after the
Effective Date from another source that is not under an obligation to the other
Party or another Person to keep such documents and information confidential.
(c)    In the event that a Party (or any of its Affiliates) is requested or
required by oral question, interrogatory, request for information or documents,
subpoena, civil investigative demand or similar process or by applicable Law or
any listing or trading agreement concerning its securities to disclose any
Confidential Information of the other Party, such Person shall (i) provide the
other Party with prompt notice so that such other Party may seek a protective
order or other appropriate remedy or, in such other Party’s sole discretion,
waive compliance with the provisions of this Section 5.9 and (ii) cooperate with
the other Party, at such other Party’s expense, in any effort to obtain a
protective order or other remedy. In the event that such protective order or
other remedy is not obtained or the other Party waives compliance with the
provisions of this Section 5.9, such Person shall (x) disclose only that portion
of the Confidential Information that such Person is advised, by its counsel, is
legally required and shall use commercially reasonable efforts to obtain
reliable assurance that confidential treatment is accorded the Confidential
Information so disclosed (to the extent available) and (y) use reasonable best
efforts to promptly furnish to the other Party a copy (in whatever form or
medium) of such Confidential Information that it intends to furnish.
(d)    Notwithstanding anything in this Section 5.9, each Party may disclose
this Agreement and its terms and conditions in securities filings with the
Securities Exchange Commission (the “SEC”) or equivalent foreign agency to the
extent required by applicable Law after complying with the procedure set forth
in this Section 5.9(d). In the event a Party is required to file a Form 8-K,
such Party shall provide the other Party with a copy of such Form 8K and such
other Party agrees to promptly review such disclosure within one (1) Business
Day of receipt of such Form 8-K. In addition, such Party shall prepare a
proposed redacted version of this Agreement to request confidential treatment
for this Agreement, and the other Party agrees to promptly (and in any event, no
less than seven (7) days after receipt of such proposed redactions) give its
input in a reasonable manner in order to allow the Party seeking disclosure to
file its request within the time lines specified by applicable Law. The Party
seeking such disclosure shall reasonably consider any comments thereto provided
by the other Party within such one (1) day or seven (7) day period, as
applicable, and shall use reasonable efforts to obtain confidential treatment of
this Agreement from the SEC (or equivalent foreign agency) as represented by the
redacted version revised by the other Party. If both Parties determine that they
are required to disclose this Agreement and its terms and conditions in
securities filings as described in the first sentence of this Section 5.9(d),
then the Parties shall use good faith efforts to agree upon a redacted version
of this Agreement for which each Party will request confidential treatment and
to coordinate with each other with respect to any revisions to such redacted
version requested or required by the SEC or equivalent foreign agency.

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(e)    The Confidentiality Agreement is hereby terminated as of the Effective
Date, without further action by any party thereto and information exchanged
under the Confidentiality Agreement shall be deemed to be exchanged under this
Agreement.
5.10    Termination of the NYU License. In the event of termination of the NYU
License Purchaser shall provide Sellers with written notice within five (5)
business days of termination, or within five (5) business days of receipt of a
notice to terminate, whichever the earlier.
5.11    Expenses. Each of the Parties shall bear its own expenses incurred in
connection with the preparation, execution and performance of this Agreement and
the Acquisition, including all fees and expenses of its representatives.
ARTICLE 6

GENERAL
6.1    Indemnification
(a)    Indemnification by Sellers. Sellers shall indemnify and hold harmless
Purchaser and its Affiliates and their respective Representatives (the
“Purchaser Indemnified Parties”) from and against any and all Damages incurred
by any Purchaser Indemnified Party in connection with any claim, demand, action,
proceeding, or investigation relating to or arising from:
(i)    any breach by a Seller of any warranty or the inaccuracy of any
representation of such Seller contained in this Agreement, the Transaction
Documents or in any other agreement or instrument contemplated by this
Agreement;
(ii)    any breach by a Seller of any of such Sellers’ covenants contained in
this Agreement, the Transaction Documents or in any other agreement or
instrument contemplated by this Agreement; or
(iii)    the practice of the license set forth in Section 5.6(a);
(iv)    any third-party claim to the extent Damages resulting therefrom are (1)
as a result of the use of, or the research, development, manufacture,
commercialization, use or sale of, any Compound or Product by or on behalf of a
Seller or any of its Affiliates, licensees or sublicensees prior to the
Effective Date and (2) not Damages for which the Seller Indemnitees are entitled
to seek indemnification pursuant to Section 6.1(b).
(b)    Indemnification by Purchaser. Purchaser shall indemnify and hold harmless
Sellers and their respective Representatives (the “Seller Indemnified Parties”)
from and against any and all Damages incurred by any Seller Indemnified Party in
connection with any claim, demand, action, proceeding, or investigation relating
to or arising from:
(i)    any breach by Purchaser of any warranty or the inaccuracy of any
representation of Purchaser contained in this Agreement, the Transaction
Documents or in any other agreement or instrument contemplated by this
Agreement;

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(ii)    any breach by Purchaser of any of Purchaser’s covenants contained in
this Agreement, the Transaction Documents or in any other agreement or
instrument contemplated by this Agreement;
(iii)    any Assumed Liability; and
(iv)    any third-party claim to the extent Damages resulting therefrom are (i)
as a result of the use of, or the research, development, manufacture,
commercialization, use or sale of, any Compound or Product by or on behalf of
Purchaser or any of its Affiliates or Sublicensees after the Effective Date and
(ii) not Damages for which the Purchaser Indemnitees are entitled to seek
indemnification pursuant to Section 6.1(a).
(c)    Third Party Claims. If any action at law or suit in equity is instituted
by or against a third party with respect to which any Purchaser Indemnified
Party or Seller Indemnified Party (the “Indemnified Party”) believes is
reasonably likely to result in Damages under this Section 6.1, such Indemnified
Party shall promptly notify the other Party (the “Indemnifying Party”) of such
action or suit; provided that any delay or failure to so notify shall not
relieve the Indemnifying Party of its obligations hereunder except to the extent
Indemnifying Party is materially prejudiced by such delay or failure.
Indemnifying Party shall, promptly and in no event later than five (5) days
after receipt of the notice, notify such Indemnified Party whether Indemnifying
Party elects to conduct and control such action or suit, but only after
confirming in writing to such Indemnified Party that it accepts responsibility
to indemnify such Indemnified Party for all Damages arising from such action or
suit. If Indemnifying Party provides the foregoing notice, Indemnifying Party
shall have the right to conduct and control, at its sole expense and with
counsel of its choice (which counsel must be reasonably satisfactory to such
Indemnified Party), such action or suit, and such Indemnified Party shall
reasonably cooperate in connection therewith; provided that Indemnifying Party
shall not settle such action or suit without the prior consent of such
Indemnified Party (not to be unreasonably withheld, conditioned or delayed),
unless the third-party claimant and Indemnifying Party provide to such
Indemnified Party an unqualified release from all liability in respect of such
action or suit and such settlement, compromise or judgment does not involve any
nonmonetary penalty or admission of fault or liability on the part of such
Indemnified Party or its Affiliates. Such Indemnified Party may participate in
the defense of such action or suit that is defended by Indemnifying Party with
counsel of its choice; provided, however, that the fees and expenses of such
Indemnified Party’s counsel shall be paid by such Indemnified Party unless (i)
Indemnifying Party has agreed in writing to pay such fees and expenses or (ii)
such Indemnified Party shall have reasonably determined based on the advice of
counsel that a conflict or potential conflict exists between Indemnifying Party
and such Indemnified Party that would make such separate representation
advisable or there are one or more factual or legal defenses available to such
Indemnified Party that are different or in addition to those that are available
to Indemnifying Party.
(d)    Right of Set-Off. Notwithstanding anything to the contrary in this
Agreement, and without prejudice to any other right or remedy it has or may
have, Purchaser may set off or recoup any indemnification payments owed to it by
Seller pursuant to Section 6.1(b) against any Milestone Payments or Royalties to
Seller pursuant to Sections 2.4 and 2.5, respectively.

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6.2    Liability. NO PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE WHETHER IN
CONTRACT, TORT (INCLUDING NEGLIGENCE), BREACH OF STATUTORY DUTY, RESTITUTION OR
OTHERWISE) FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL LOSSES, WHETHER OR NOT THE
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH TYPES OF DAMAGES.
6.3    Anti-bribery and anti-corruption
(a)    In performing their respective obligations hereunder, the Parties
acknowledge that the corporate policies of Purchaser and Sellers and their
respective Affiliates require that each Party’s business be conducted within the
letter and spirit of the law. By signing this Agreement, each Party agrees to
conduct the business contemplated herein in a manner which is compliant with all
Laws, including the U.S. Foreign Corrupt Practices Act, the UK Bribery Act 2010,
good business ethics, and its ethics and other corporate policies. Specifically,
each Party agrees that it has not, and covenants that it, its Affiliates, and
its and its Affiliates’ directors, employees, officers, and anyone acting on its
behalf, will not, in connection with the performance of this Agreement, directly
or indirectly, make, promise, authorize, ratify or offer to make, or take any
action in furtherance of, any payment or transfer of anything of value for the
purpose of influencing, inducing or rewarding any act, omission or decision to
secure an improper advantage; or improperly assisting it in obtaining or
retaining business for it or the other Party, or in any way with the purpose or
effect of public or commercial bribery.
(b)    Neither Party shall contact, nor otherwise knowingly meet with, any
Government Official for the purpose of discussing activities arising out of or
in connection with this Agreement, without the prior written approval of the
other Party, except where such meeting is consistent with the purpose and terms
of this Agreement and in compliance with Laws.
(c)    Each Party shall ensure that all transactions under the Agreement are
properly and accurately recorded in all material respects on its books and
records and that each document upon which entries in such books and records are
based is complete and accurate in all material respects. Each Party further
represents, warrants and covenants that all books, records, invoices and other
documents relating to payments and expenses under this Agreement are and shall
be complete and accurate and reflect in reasonable detail the character and
amount of transactions and expenditures. Each Party must maintain a system of
internal accounting controls reasonably designed to ensure that no off-the-books
or similar funds or accounts will be maintained or used in connection with this
Agreement.
(d)    Each Party agrees to ensure that all of its employees involved in
performing its obligations under this Agreement are made specifically aware of
the compliance requirements under this Section 6.3. In addition, each Party
agrees to ensure that all such employees participate in and complete mandatory
compliance training to be conducted by each Party, including specific training
on anti-bribery and corruption, in accordance with such Party’s standard
operating procedures with respect to training.
6.4    Notices. All notices or other communications required or permitted to be
given hereunder shall be in writing and shall be delivered by hand or sent by
facsimile or email or sent,

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postage prepaid, by registered, certified or express mail or overnight courier
service and shall be deemed given when so delivered by hand or facsimile, upon
receipt of confirmation if sent by email, or if mailed, three (3) Business Days
after mailing (one Business Day in the case of express mail or overnight courier
service), to the parties at the following addresses, facsimiles or email
addresses (or at such other address, facsimile or email address for a Party as
shall be specified in a notice given in accordance with this Section 6.4):
(a)    If to Purchaser:
[***]
(b)    If to Sellers:
[***]
6.5    Severability. If any provision of this Agreement for any reason shall be
held to be illegal, invalid or unenforceable, such illegality shall not affect
any other provision of this Agreement, but this Agreement shall be construed as
if such illegal, invalid or unenforceable provision had never been included
herein.
6.6    Succession and Assignment. This Agreement shall be binding upon and inure
to the benefit of the Parties named herein and their respective personal
representatives, heirs, successors and permitted assigns. No Party may assign
either this Agreement or any of its rights, interests or obligations hereunder
without the prior written consent of the other Party; provided, that each Party
may assign (a) any or all of its rights, interests or obligations hereunder to
one or more of its Affiliates or (b) all of its rights, interests and
obligations hereunder to its successor in interest in connection with a merger,
acquisition or similar transaction or the sale of all or substantially all of
its stock or assets. Any attempted assignment not in accordance with this
Section 6.6 shall be null and void and of no legal effect. Any permitted
assignee shall assume all assigned obligations of its assignor under this
Agreement. The terms and conditions of this Agreement shall be binding upon, and
shall inure to the benefit of, the Parties and their respected successors and
permitted assigns.
6.7    No Third-Party Beneficiaries. This Agreement is for the sole benefit of
the Parties and their successors and permitted assigns and nothing herein
expressed or implied shall give or be construed to give to any Person, other
than the Parties and such successors and assigns, any legal or equitable rights
hereunder.
6.8    Incorporation of Exhibits. All Exhibits and Schedules attached hereto and
referred to herein are hereby incorporated herein and made a part of this
Agreement for all purposes as if fully set forth herein.
6.9    Governing Law and Jurisdiction. THIS AGREEMENT SHALL BE GOVERNED BY, AND
CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF [***] OTHER THAN CONFLICT
OF LAWS PRINCIPLES THEREOF DIRECTING THE APPLICATION OF ANY LAW OTHER THAN THAT
OF DELAWARE. The courts of the State

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of Delaware shall have jurisdiction with respect to any dispute between the
Parties arising under or in connection with this Agreement, and the Parties
submit to the jurisdiction of those courts
6.10    Dispute Resolution.
(a)    Notwithstanding the provisions of Section 6.9 above, in the case of any
dispute between the Parties any matters in dispute shall be first referred to
the Chief Executive Officer of Purchaser and the Chief Executive Officer of Orca
Ltd (collectively, the “Executives”), and the Parties shall attempt to resolve
it in good faith through their Executives within thirty (30) days. Any final
decision mutually agreed to by the said Executives shall be in writing and shall
be conclusive and binding on the Parties. All discussions under this Section
6.10 shall be confidential and shall be treated as settlement negotiations for
purposes of applicable rules of evidence.
(b)    If the Executives are unable to resolve the dispute within the period
specified in Section 6.10(a), then the Parties may seek to have the dispute
resolved pursuant to last sentence of Section 6.9.
(c)    Nothing contained in this Agreement shall deny either Party the right to
seek injunctive or other equitable relief from a court of competent jurisdiction
in the context of a bona fide emergency or prospective irreparable harm, and
such an action may be filed or maintained notwithstanding any ongoing
discussions between the Parties.
6.11    Headings; Interpretation. The descriptive headings contained in this
Agreement are included for convenience of reference only and shall not affect in
any way the meaning or interpretation of this Agreement. The Parties have
participated jointly in the negotiation and drafting of this Agreement. In the
event an ambiguity or question of intent or interpretation arises, this
Agreement shall be construed as if drafted jointly by the Parties, and no
presumption or burden of proof shall arise favoring or disfavoring any Party by
virtue of the authorship of any provisions of this Agreement.
6.12    Counterparts; Facsimiles. This Agreement may be executed and delivered
(including by electronic or facsimile transmission) in two or more counterparts,
and by the different parties hereto in separate counterparts, each of which when
executed and delivered shall be deemed to be an original but all of which taken
together shall constitute one and the same agreement.
6.13    Entire Agreement. This Agreement (including the Schedules and Exhibits
attached hereto) and [***] executed in connection with the consummation of the
[***], contain the entire agreement between the Parties with respect to the
subject matter hereof and related transactions and supersede all prior
agreements, written or oral, with respect thereto.
6.14    Specific Enforcement. The Parties agree that irreparable damage would
occur in the event that any of the provisions of this Agreement were not
performed in accordance with their specific terms or were otherwise breached or
threatened to be breached and that an award of money damages would be inadequate
in such event. Accordingly, it is acknowledged that the Parties shall be
entitled to equitable relief, without proof of actual damages, to enforce
performance of this Agreement in accordance with its terms, including an Order
for specific performance, to prevent

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breaches of this Agreement and to enforce specifically the terms and provisions
of this Agreement, in addition to any other remedy under this Agreement. Each
Party further agrees that neither the other Party nor any other Person shall be
required to obtain, furnish or post any bond or similar instrument in connection
with or as a condition to obtaining any remedy referred to in this Section 6.14,
and each Party hereto irrevocably waives any right it may have to require the
obtaining, furnishing or posting of any such bond or similar instrument.
6.15    Waivers and Amendments; Non-Contractual Remedies; Preservation of
Remedies. This Agreement may be amended, superseded, canceled, renewed or
extended only by a written instrument signed by all of the Parties. The
provisions hereof may be waived only in writing signed by all of the Parties. No
delay on the part of any Party in exercising any right, power or privilege
hereunder shall operate as a waiver thereof, nor shall any waiver on the part of
any Party of any such right, power or privilege, nor any single or partial
exercise of any such right, power or privilege, preclude any further exercise
thereof or the exercise of any other such right, power or privilege. Except as
otherwise provided herein, the rights and remedies herein provided are
cumulative and are not exclusive of any rights or remedies that any Party may
otherwise have at Law or in equity.
[Signatures appear on next page]

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IN WITNESS WHEREOF, intending to be legally bound hereby, the Parties have
caused this Agreement to be signed in their respective names by their duly
authorized representatives as of the date first above written.
BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer
Name: Andrew Sklawer
Title: COO

ORCA PHARMACEUTICALS LLC

By: /s/ Michael Hunter
Name: Michael Hunter
Title: CEO

ORCA PHARMACEUTICALS LIMITED

By: /s/ Baiju R. Shah
Name: Baiju R. Shah
Title: Director

22

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EXHIBIT A
NYU LICENSE AGREEMENT

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Execution Copy
SECOND RESTATED LICENSE AGREEMENT
This Restated License Agreement (this “Agreement”), effective as of June 6, 2013
(the “Effective Date”) and first amended as of 28 January 2015 (the “License
Restatement Effective Date”), and subsequently amended as of 23 November 2015
(the “Second License Restatement Effective Date”) is by and between:
NEW YORK UNIVERSITY (hereinafter “NYU”), a corporation organized and existing
under the laws of the State of New York and having a place of business at 70
Washington Square South, New York, New York, 10012.
AND
ORCA PHARMACEUTICALS LLC (hereinafter “CORPORATION”), a limited liability
company organized and existing under the laws of the State of Delaware having
its principal office at 3605 Warrensville Center Rd., MSC 2394, Cleveland, OH
44122.
RECITALS
WHEREAS, [***], an employee of the Howard Hughes Medical Institute (“HHMI”) and
a faculty member at NYU; and [***], an employee of NYU (hereinafter “the NYU
Scientists”) have made certain inventions relating to [***], all as more
particularly described in pending U.S. patent applications and counterpart
foreign patent applications owned by NYU, identified in annexed Appendix I.A and
forming an integral part hereof (hereinafter “the NYU Pre-Existing Inventions”);
WHEREAS, the NYU Scientists and researchers of the National Institutes of Health
(hereinafter “NIH”) have made certain inventions relating to [***], all as more
particularly described in pending U.S. patent applications and counterpart
foreign patent applications jointly owned by NYU and the NIH, identified in
annexed Appendix I.13 and forming an integral part hereof (hereinafter “the
NYU/NIH Pre-Existing Inventions”);
WHEREAS, the [***] with NYU dated 05/13/2013, 07/23/2012 and 06/26/2012 attached
hereto as Appendix IV under which [***] (the “Inter-Institutional Agreements”);
WHEREAS, HHMI has assigned its rights in the NYU Pre-Existing Inventions and
NYU/NIH Pre-Existing Inventions to NYU, subject to an HHMI License (as
hereinafter defined).
WHEREAS, the parties entered into a license agreement dated June 7, 2013 for the
NYU Pre-Existing Inventions, the NYU/NIH Pre-Existing Inventions and the NYU
Know-How (as defined below) (the “Original License”);
WHEREAS, the parties have previously re-stated the Original License in two
agreements: a Restated License Agreement dated January 28, 2015 (the “Restated
Agreement”) and a separate know-how license to the NYU Know-How dated January
28, 2015; and WHEREAS, subject to the terms and conditions hereinafter set
forth, NYU and CORPORATION are willing to restate the

Exhibit A-1

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Restated Agreement to provide that NYU grants to CORPORATION and CORPORATION
accepts from NYU the license to the NYU Pre-Existing Inventions, the NYU/NIH
Pre-Existing Inventions and the NYU Know-How on the terms set out below;
NOW, THEREFORE, in consideration of the mutual promises and agreements contained
herein, the parties hereto hereby agree as follows:
1.Definitions.
1.01    “Affiliate” shall mean any company or other legal entity which controls,
or is controlled by, or is under common control with, CORPORATION; control for
purposes of this definition means the holding of (i) fifty percent (50%) or more
of the capital and/or the voting rights and/or (H) the right to elect or appoint
fifty percent (50%) or more of the directors.
1.02    “Agreement Year” shall mean the yearly period beginning on the License
Restatement Effective Date and each succeeding year thereafter for the term of
the Agreement.
1.03    “Date of First Commercial Sale” shall mean, [***] the date on which a
Licensed Product is first sold by CORPORATION or an Affiliate or sublicensee of
CORPORATION.
1.04    “Field” shall mean all fields and uses.
1.05    “License” shall mean (i) the [***] the NYU/NIH Patents (as hereinafter
defined), and (ii) the [***] the NYU Patents and the NYU Know-How (as
hereinafter defined); in each case [***]
1.06    “Licensed Patents” shall mean the NYU Patents and the NYU/NIH Patents.
1.07    “Licensed Products” shall mean Licensed Compound Products and Licensed
Know-How Products.
1.08    “Licensed Compound Products” shall mean all products which in the
absence of the License would infringe any Valid Claim.
1.09    “Licensed Know-How Products” shall mean all products that are (i) not
Licensed Compound Products, and (ii) which also are not Series 2 Licensed
Products (as hereinafter defined), and (Hi) which either incorporate or are
discovered or developed using NYU Know-How.
1.10    “Licensed Technology” shall mean all [***]
1.11    “Net Sales” shall mean the total amount invoiced by CORPORATION, its
Affiliates, and its sublicensees in connection with sales of the Licensed
Products to any person or entity that is not an Affiliate or a sublicensee of
CORPORATION under the License, after deduction of all the following to the
extent applicable to such sales;
i)
all trade, case and quantity credits, discounts, refunds or rebates, including
Medicaid, managed care and other such rebates;

Exhibit A-2

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ii)
allowances or credits for returns and recalls;

iii)
sales taxes (including value-added tax), custom duties and other governmental
charges levied on sales of Licensed Product; and

iv)
amounts for transportation, transportation insurance, handling and shipping.

If CORPORATION, a CORPORATION Affiliate, or any sublicensee sells any Licensed
Product in [***] containing [***], Net Sales of such [***] for the purpose of
determining [***] to NYU pursuant to Section 6.01(c) will be calculated by [***]
If, on a country-by-country basis, such other [***] are not sold separately in
such country, but the Licensed Product component of [***] in such country, Net
Sales for the purpose of [***] shall be [***]. If, on a country-by-country
basis, such Licensed Product component is not sold separately in such country,
Net Sales of [***] for the purposes of [***] for the [***] shall be [***] of
CORPORATION and NYU, based upon [***] and available market information.
Notwithstanding anything above to the contrary, in no event shall [***]
1.12    “NYU Know-Hove shall mean any information that was discovered, developed
or acquired by, or on behalf of the NYU Scientists as of the Effective Date and,
in each case, provided by NYU to CORPORATION, including but not limited to the
information listed in Appendix II.
1.13    “NYU Patents” shall mean the patent applications listed in Appendix I.A
and any divisions, continuations or claims of foreign counterparts thereof, or
patents issuing thereon, or reissues, renewals and extensions thereof which are
directed to subject matter specifically described in the patent applications
listed in Appendix I.A.
1.14    “NYU/NIH Patents” shall mean the patent applications listed in Appendix
I.13 and any divisions, continuations, continuations-in-part (but only to the
extent that such continuations-in-part claim inventions specifically described
in, and are directed to subject matter specifically described in, the patent
applications listed in Appendix 1.B) or claims of foreign counterparts thereof,
or claims of patents issuing thereof which are directed to subject matter
specifically described in the patent applications listed in Appendix 1.B, or
reissues, renewals and extensions thereof which are directed to subject matter
specifically described in the patent applications listed in Appendix I.B.
1.15    “Series 2 Licensed Products” shall mean the series of compounds
generated solely by Orca Pharmaceuticals Limited or on Orca Pharmaceuticals
Limited’s behalf and which [***] as filed, [***]
1.16    “Valid Claim” shall mean on a territory by territory basis, any claim of
any issued unexpired Licensed Patent or any pending patent application within
Licensed Patents which has been pending for less than five (5) years from the
earliest date to which it claims priority, in each case which has not been
disclaimed, permitted to lapse or held invalid by a court of competent
jurisdiction or patent office from which no appeal can be taken or is taken
within the time limits provided for such an appeal.

Exhibit A-3

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2.    Effective Date.
This Agreement shall be effective as of the Effective Date and shall remain in
full force and effect until it expires or is terminated in accordance with
Section 13 hereof.
3.    Title.
3.01    Subject to the License granted to CORPORATION hereunder, and the HHMI
License, it is hereby agreed that all right, title and interest, in and to the
(i) NYU Patents and NYU Know-How, and in and to any drawings, plans, diagrams,
specifications, and other documents containing any of the NYU Patents and NYU
Know-How shall [***] and (ii) NYU/NIH Patents, and in and to any drawings,
plans, diagrams, specifications, and other documents containing any of the
NYU/NIH Patents shall [***]. At the request of NYU, CORPORATION shall take [***]
as may be [***] to give full effect to said right, title and interest of NYU and
NIH including, but not limited to, the execution of any documents that may be
required to record such right, title and interest with the appropriate agency or
government office.
3.02    For so long as each of the NYU Scientists is employed by NYU or HHMI,
any and all inventions made by such NYU Scientist and relating to the Field
shall be owned [***] (as hereinafter defined).
3.03    NYU shall not terminate [***] without CORPORATION’s prior written
consent. If NYU receives any notice pursuant to Section 10.3 of one or more of
[***], NYU shall provide CORPORATION with a copy of such notice [***], shall
permit CORPORATION to control the content of and approve the response [***] with
respect to such notice, in consultation with NYU, and shall permit CORPORATION
to participate in any discussions or other communication [***] regarding any
potential termination of [***] thereof.
4.    Patents and Patent Applications.
4.01    [***]
4.02    At the initiative of CORPORATION or NYU, the parties shall consult with
each other regarding the prosecution of all patent applications with respect to
the NYU/NIH Patents. Copies of all such patent applications, patent office
actions and proposed responses shall be forwarded to each of NYU and CORPORATION
sufficiently prior to filing to allow for review and comment by each party, and
the comments of each party shall be reasonably considered.
4.03    Subject to Section 4.02, all applications and proceedings with respect
to the NYU/NIH Patents shall be filed, prosecuted and maintained by CORPORATION
at the expense of CORPORATION. CORPORATION may select patent counsel, NYU may
object to appointment of patent counsel where it believes such patent counsel
are not qualified to file, prosecute and maintain the NYU/NIH Patents on behalf
of CORPORATION. Where such objection is received, CORPORATION shall select
alternative counsel reasonably acceptable to NYU, such acceptance not to be
unreasonably withheld. CORPORATION shall file and prosecute the NYU/NIH Patents
in good faith to obtain as broad a protection as reasonably possible, based on
advice received from

Exhibit A-4

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its patent counsel on obtaining such broad protection. The final decision in
relation to any prosecution shall vest with CORPORATION.
4.04    If at any time during the term of this Agreement CORPORATION decides
that it is undesirable, as to one or more countries, to prosecute or maintain
any patents or patent applications within the NYU/NI H Patents, it shall give
prompt written notice thereof to NYU at least 60 days in advance of any
deadline, and upon receipt of such notice CORPORATION shall be released from its
obligations to bear all of the expenses to be incurred thereafter as to such
countries in conjunction with such patent(s) or patent application(s) and such
patent(s) or application(s) shall be deleted from the Licensed Technology and
NYU shall be free to prosecute such patents or patent applications at its sole
discretion and expense, and to grant rights in and to such patent(s) or patent
application(s) in such countries to third parties, without further notice or
obligation to CORPORATION, and the CORPORATION shall have no rights whatsoever
to exploit such patent(s) or patent application(s) in such countries.
4.05    NYU shall prosecute the NYU Patents at its sole discretion and expense
and may abandon any NYU Patents at NYU’s sole discretion.
4.06    Subject to Section 16, Nothing herein contained shall be deemed to be a
warranty by NYU, NIH, or HHMI that
i)
NYU can or will be able to obtain any patent or patents on any patent
application or applications in the Licensed Patents or any portion thereof, or
that any of the Licensed Patents will afford adequate or commercially worthwhile
protection, or

ii)
that the manufacture, use, or sale of any element of the Licensed Technology or
any Licensed Product will not infringe any patent(s) of a third party.

4.07    CORPORATION and any Affiliates and sublicensees of CORPORATION shall
insure that they apply patent markings that meet all requirements of U.S. law,
35 U.S.C. § 287, with respect to all Licensed Products.
5.    Grant of License.
5.01    Subject to the terms and conditions hereinafter set forth, NYU hereby
grants to CORPORATION and CORPORATION hereby accepts from NYU the License.
5.02    NYU reserves [***].
5.03    The parties acknowledge that the United States government retains rights
in intellectual property funded under any grant or similar contract with a
Federal agency. The License is expressly subject to all applicable United States
government rights, including, but not limited to, any applicable requirement
that products, which result from such intellectual property and are sold in the
United States, must be substantially manufactured in the United States. NYU will
take all

Exhibit A-5

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actions reasonably requested by CORPORATION, at CORPORATION’s expense, to obtain
a waiver from the United States government of such substantial manufacture
requirement.
5.04    The parties acknowledge that the Licensed Technology was developed, at
least in part, by [***]
5.05    The License granted to CORPORATION in Section 5.01 hereto shall commence
upon the Effective Date and shall remain in force [***], if not previously
terminated under the terms of this Agreement for [***] or until the expiration
date of the last to expire of the NYU Patents and the NYU/NIH Patents that cover
such Licensed Product [***], whichever shall be later (the “License Term”).
CORPORATION shall inform NYU in writing of the Date of First Commercial Sale
with respect to each Licensed Product [***] as soon as practicable after the
making of each such first commercial sale. Following the expiration of the
License Term, [***], CORPORATION shall [***].
5.06    CORPORATION shall be entitled to [***] under the License on terms and
conditions in compliance and not inconsistent with the terms and conditions of
this Agreement (except that [***] (i) to an Affiliate or (ii) to other third
parties for consideration and in an arms-length transaction. The NYU Patents may
only be [***]. All [***] shall only be granted by CORPORATION under a written
agreement, a copy of which shall be provided by CORPORATION to NYU and NIH as
soon as practicable after the signing thereof; provided, that, (a) the copy of
the [***] may be redacted by CORPORATION with respect to obligations that are
not relevant to this Agreement and (b) the terms of each such [***] shall be
Confidential Information of CORPORATION for purposes of this Agreement. Each
[***] granted by CORPORATION hereunder shall be subject and subordinate to the
terms and conditions of this Agreement and shall contain (inter-alia) the
following provisions:
(1)
[***]

(2)
[***]

(3)
[***]

(4)
[***]

(5)
[***]

(6)
[***]

6.    Payments for License.
6.01    In consideration for the grant and during the term of the License with
respect to each Licensed Product, CORPORATION shall pay to NYU:
(a)
[***]; and

(b)
Within [***] after [***] with respect to each Licensed Compound Product and each
Licensed Know-How Product, the payments as indicated below:

Exhibit A-6

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

The foregoing [***] with respect to the [***], regardless of how many times
[***]. If a particular above [***] is achieved by a sublicensee of CORPORATION,
and if CORPORATION [***], for which a payment is due to NYU under Section
6.01(d) below, then NYU shall [***] For example, if [***] shall fully satisfy
CORPORATION’s obligations to NYU pursuant to this Section 6.01(b) and Section
6.01(d).
(c)
[***]; and

(d)
[***] under the terms of, or as a consideration for the grant of, a sublicense
of any rights hereunder or for [***] such a sublicense, based upon the
development stage of the [***] included in such grant at the time of the grant
other than [***]:

(I)
[***]

(II)
[***]

(III)
[***]

6.02    For the purpose of [***] hereunder, the year shall be divided into four
parts ending on March 31, June 30, September 30, and December 31. Not later than
sixty (60) days after each December, March, June, and September in each
Agreement Year during the term of the License, CORPORATION shall submit to NYU a
full and detailed report [***] NYU under the terms of this Agreement for the
preceding quarter year (hereinafter “the Quarter-Year Report”), setting forth
the [***] including:
i)
[***];

ii)
[***];

iii)
[***]

iv)
[***]

If no [***] payments are due, a statement shall be sent to NYU stating such
fact. Payment of the full amount of [***] for the preceding quarter year shall
accompany each Quarter-Year Report on [***]. CORPORATION shall keep for a period
of at least [***], full, accurate and compete books

Exhibit A-7

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and records consistent with sound business and accounting practices and in such
form and in such detail as to enable [***] to NYU from CORPORATION pursuant to
the terms of this Agreement.
6.03    Within sixty (60) days after the end of each Agreement Year, commencing
on the Date of First Commercial Sale CORPORATION shall furnish NYU with a report
(hereinafter “the Annual Report”), relating to [***] pursuant to this Agreement
in respect of the Agreement Year covered by such Annual Report and containing
the same details as those specified in Section 6.02 above in respect of the
Quarter-Year Report.
6.04    On [***] notice and during regular business hours and not more than once
per calendar year, NYU or the authorized representative of NYU shall each have
the right to designate an independent, certified public accountant reasonably
acceptable to CORPORATION to inspect the books of accounts, records and other
relevant documentation of CORPORATION or of any Affiliate of CORPORATION insofar
as they relate to the production, marketing and sale of the Licensed Products,
in order to [***] hereunder, and the accuracy of the information provided to NYU
in the aforementioned reports. The cost of such inspection shall be borne by
NYU, unless it is determined in such inspection that NYU has been underpaid in
any period by more than [***] of the amount which NYU should have been paid, in
which case the cost of such inspection shall be reimbursed to NYU by
CORPORATION.
7.    Method of Payment.
7.01    [***] hereunder shall be paid to NYU in [***]. Any such [***] based on
the closing buying rate listed at [***] on the last business day of the
accounting period for which such royalty or other payment is due.
7.02    CORPORATION shall be responsible for payment to NYU of [***] by each
Affiliate of CORPORATION.
7.03    Any amount payable hereunder by one of the parties to the other, which
has not been paid by the date on which such payment is due, shall bear interest
form such date until the date on which such payment is made, at the rate of
[***] per annum in excess of the prime rate prevailing at the Citibank, N.A., in
New York, during the period of arrears and such amount and the interest thereon
may be set off against any amount due, whether in terms of this Agreement or
otherwise, to the party in default by any non-defaulting party.
8.    Development and Commercialization.
8.01     CORPORATION undertakes to use [***] to carry out the Development Plan
(annexed hereto as Appendix III and which is an integral part of this Agreement,
as such Development Plan may be updated from time-to-time by mutual agreement of
the parties), including but not limited to, the performance of all efficacy,
pharmaceutical, safety, toxicological and clinical tests, trials and studies and
all other activities necessary in order to obtain the approval of the FDA for
the production, use and sale of the Licensed Products, all as set forth in the
Development Plan (as updated from time-to-time by mutual agreement of the
parties) and within all timetables set forth therein. CORPORATION further
undertakes to exercise [***], and to include in each

Exhibit A-8

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sublicense agreement an obligation of such sublicensee, to [***], to obtain the
appropriate approvals of the health authorities for the production, use and sale
of the Licensed Products, [***] in which CORPORATION or its sublicensees intend
to produce, use, and/or sell Licensed Products.
8.02    Provided that applicable laws, rules and regulations require that the
performance of the tests, trials, studies and other activities specified in
Paragraph 8.01 above shall be carried out in accordance with FDA Good Laboratory
Practices and in a manner acceptable to the relevant health authorities,
CORPORATION shall carry out such tests, trials, studies and other activities in
accordance with FDA Good Laboratory Practices and in a manner acceptable to the
relevant health authorities. Furthermore, the Licensed Products shall be
produced in accordance with FDA Good Manufacturing Practice (“GMP”) procedures
in a facility which has been certified by the FDA as complying with GMP,
provided that applicable laws, rules and regulations so require.
8.03    CORPORATION agrees to use [***] to begin the regular commercial
production, use, and sale of the Licensed Products [***] in accordance with the
Development Plan and to continue diligently thereafter to commercialize the
Licensed Products.
8.04    CORPORATION shall provide NYU with written reports on all activities and
actions undertaken by CORPORATION to develop and commercialize the Licensed
Products; such reports shall be made within sixty (60) days after each six (6)
months during the term of this Agreement, commencing six (6) months after the
Effective Date. CORPORATION shall include sufficient details in such reports for
NYU to ascertain CORPORATION’s progress in developing and commercializing
Licensed Products.
9.    CONFIDENTIAL INFORMATION.
9.01    “Confidential Information” shall mean non-public information provided by
one party (a “Disclosing Party”) to the other party (“Recipient”). Except as
otherwise provided in Section 9.02 and 9.03 below, each Recipient shall maintain
any and all of the Confidential Information in confidence and shall not release
or disclose any tangible or intangible component thereof to any third party
without first receiving the prior written consent of, the Disclosing Party to
said release or disclosure.
9.02    The obligations of confidentiality set forth in Sections 9.01 shall not
apply to any Confidential Information that (i) is or becomes publicly available
through no wrongful act of Recipient; (ii) was known by Recipient prior to
disclosure by the Disclosing Party, as evidenced by tangible records; (iii)
becomes known to Recipient after disclosure from a third party having an
apparent bona fide right to disclose it; (iv) is independently developed or
discovered by Recipient without use of the Disclosing Party’s Confidential
Information, as evidenced by tangible records; or (v) is disclosed to another
party by the Disclosing Party without restriction on further disclosure.
9.03    Recipient shall have the right to, and agrees that it will, use the
Disclosing Party’s Confidential Information solely as provided under this
Agreement, except a Recipient may disclose Confidential Information of the
Disclosing Party to (x) its Affiliates, and to its and their directors,
employees, consultants, and agents in each case who have a specific need to know
such Confidential Information and who are bound by a like obligation of
confidentiality and restriction on use, (y)

Exhibit A-9

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any bona fide actual or prospective collaborators, sublicensees, underwriters,
investors, lenders or other financing sources who are obligated to keep such
information confidential, to the extent reasonably necessary to enable such
actual or prospective collaborators, sublicensees, underwriters, investors,
lenders or other financing sources to determine their interest in collaborating
with, sublicensing, underwriting or making an investment in, or otherwise
providing financing to, the Recipient, and (z) the extent such disclosure is
required to comply with applicable law or regulation or the order of a court of
competent jurisdiction or to defend or prosecute litigation; provided, however,
that the Recipient provides prior written notice of such disclosure to the
Disclosing Party and takes reasonable and lawful actions to avoid or minimize
the degree of such disclosure. Notwithstanding any other provision of this
Agreement, each Recipient may disclose and use Confidential Information of the
Disclosing Party as necessary to file or prosecute patent applications,
prosecute or defend litigation or otherwise establish rights or enforce
obligations under this Agreement, or to submit regulatory filings.
10.    Infringement of NYU and NYU/NIH Patents.
10.01    In the event a party to this Agreement acquires information that a
third party is infringing one or more of the NYU Patents or NYU/NIH Patents, the
party acquiring such information shall promptly notify the other party to the
Agreement in writing of such infringement.
10.02    In the event of an infringement of an NYU/NIH Patent, CORPORATION shall
have the right but not the obligation to bring suit against the infringer.
Should CORPORATION elect to bring suit against an infringer and NYU is joined as
a party plaintiff in any such suit, NYU shall have the right to approve the
counsel selected by CORPORATION to represent CORPORATION and NYU. The expenses
of such suit or suits that CORPORATION elects to bring, including the reasonable
expenses of NYU incurred in conjunction with the prosecution of such suit or the
settlement thereof, shall be paid for entirely by CORPORATION and CORPORATION
shall reimburse NYU, NIH, and HHMI for their reasonable costs and expenses
incurred in connection with such litigation, including attorneys’ fees.
CORPORATION shall not compromise or settle such litigation without the prior
written consent of NYU which shall not be unreasonably withheld.
10.03    In the event CORPORATION exercises the right to sue herein conferred,
it shall have the right to first reimburse itself out of any sums recovered in
such suit or in settlement thereof for all costs and expenses of every kind and
character, including reasonable attorneys’ fees, necessarily involved in the
prosecution of any such suit, and if after such reimbursement, any funds shall
remain from said recovery, CORPORATION shall promptly pay to NYU an amount as
follows: (i) in the case of damages representing lost profits of CORPORATION,
lost sales shall be calculated based on such lost profits and CORPORATION’s
profit margin, and [***], (ii) in the case of damages representing [***], then
such damages shall be deemed to be consideration for the grant of a sublicense,
and [***] and (iii) [***]; and, in each case, CORPORATION shall be entitled to
receive and retain the balance of the remainder of such recovery.
10.04    If CORPORATION does not bring suit against said infringer pursuant to
Section 10.02 herein, or has not commenced negotiations with said infringer for
discontinuance of said infringement, within ninety (90) days after receipt of
such notice, NYU shall have the right, but shall not be obligated, to bring suit
for such infringement. Should NYU elect to bring suit against

Exhibit A-10

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

an infringer and CORPORATION is joined as a party plaintiff in any such suit,
CORPORATION shall have the right to approve the counsel selected by NYU to
represent NYU and CORPORATION, and NYU shall reimburse CORPORATION for its
reasonable costs and expenses incurred in connection with such litigation,
including attorneys’ fees. If CORPORATION has commenced negotiations with an
alleged infringer of the NYU/NIH Patent for discontinuance of such infringement
within such 90-day period, CORPORATION shall have an additional ninety (90) days
from the termination of such initial 90-day period to conclude its negotiations
before NYU may bring suit for such infringement. In the event NYU brings suit
for infringement of any NYU/NIH Patent, NYU shall not compromise or settle any
such suit by licensing the alleged infringer without the prior consent of
CORPORATION, which shall not be unreasonably withheld. In the event NYU brings
suit for infringement of any NYU/NIH Patent, NYU shall have the right to first
reimburse itself out of any sums recovered in such suit or settlement thereof
for all costs and expenses of every kind and character, including reasonable
attorneys’ fees necessarily involved in the prosecution of such suit, and if
after such reimbursement, any funds shall remain from said recovery, [***] and
NYU shall be entitled to receive and retain the balance of the remainder of such
recovery.
10.05    Each party shall always have the right to be represented by counsel of
its own selection in any suit for infringement of the NYU/NIH Patents instituted
by the other party to this Agreement under the terms hereof. The expense of such
counsel shall be borne by the party initiating such infringement suit.
10.06    CORPORATION agrees to cooperate fully with NYU at the request of NYU,
including, by giving testimony and producing documents lawfully requested in the
prosecution of any suit by NYU for infringement of the NYU/NIH Patents;
provided, NYU shall pay all reasonable expenses (including attorneys’ fees)
incurred by CORPORATION in connection with such cooperation. NYU shall cooperate
and shall endeavor to cause the NYU Scientists to cooperate with CORPORATION at
the request of CORPORATION, including by giving testimony and producing
documents lawfully requested, in the prosecution of any suit by CORPORATION for
infringement of the NYU/NIH Patents; provided, that CORPORATION shall pay all
reasonable expenses (including attorneys’ fees) incurred by NYU in connection
with such cooperation.
10.07    NYU shall have the sole right, but not the obligation to take any
action with regard to infringement of the NYU Patents, and to retain any
recovery therefrom.
11.    Liability and Indemnification.
11.01    CORPORATION shall indemnify, defend and hold harmless NYU and NIH and
their trustees, officers, medical and professional staff, employees, students
and agents and their respective successors, heirs and assigns (the
“Indemnitees”), against any liability, damage, loss or expense (including
reasonable attorneys’ fees and expenses of litigation) incurred by or imposed
upon the Indemnitees or any one of them in connection with any claims, suits,
actions, demands or judgments (i) arising out of the design, production,
manufacture, sale, use in commerce or in human clinical trials, lease, or
promotion by CORPORATION or by a licensee, Affiliate or agent of CORPORATION of
any Licensed Product, process or service relating to, or developed pursuant to,
this Agreement or (ii) arising out of any other activities to be carried out
pursuant to this Agreement.

Exhibit A-11

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

11.02    With respect to an Indemnitee, CORPORATION’s indemnification under
subsection 11.01(i) shall apply to any liability, damage, loss or expense
whether or not it is attributable to the negligent activities of such
Indemnitee. CORPORATION’s indemnification obligation under subsection 11.0101)
shall not apply to any liability, damage, loss or expense to the extent that it
is attributable to the negligent activities of any such Indemnitee.
11.03    An Indemnitee or HHMI Indemnitee (as hereinafter defined) shall provide
CORPORATION with notice of any Claim or HHMI Claim (as hereinafter defined) for
which indemnification may be sought pursuant to this Agreement. Such notice
shall be given reasonably promptly following actual receipt of written notice
thereof. In the case of any HHMI Indemnitee, notice shall be given reasonably
promptly following actual receipt of written notice thereof by an officer or
attorney of HHMI. Notwithstanding the foregoing, the delay or failure of any
Indemnitee or HHMI Indemnitee to give reasonably prompt notice to CORPORATION of
any such Claim or HHMI Claim shall not affect the rights of such lndemnitee or
HHMI Indemnitee, as applicable, unless, and then only to the extent that, such
delay or failure is prejudicial to or otherwise adversely affects CORPORATION.
CORPORATION shall, at its own expense, provide attorneys reasonably acceptable
to the Indemnitee to defend against any actions brought or filed against any
lndemnitee hereunder with respect to the subject of indemnity contained herein,
whether or not such actions are rightfully brought. NYU or NIH, as relevant,
shall cooperate as reasonably requested (at the expense of CORPORATION) in the
investigation and defense of any Claim. NYU, HHMI, or NH-I, as relevant, shall
permit CORPORATION to assume direction and control of the defense of the Claim
or HHMI Claim (including the right to settle the Claim solely for monetary
consideration); provided, however, that CORPORATION shall not settle any Claim
or HHMI Claim without the prior written consent of NYU, HHMI or NIH, as
relevant, where such settlement (a) would include any admission of liability on
the part of the relevant Indemnitee or HHMI Indemnitee, (b) would impose any
restriction on the relevant Indemnitee’s or HHMI Indemnitee’s conduct of any of
its activities or (c) would not include an unconditional release of the relevant
lndemnitee or HHMI lndemnitee from all liability for claims that are the subject
matter of the settled Claim or HHMI Claim. CORPORATION agrees to keep each
affected lndemnitee informed of the progress in the defense and disposition of
such Claim.
11.04    HHMI, and its trustees, officers, employees, and agents (collectively,
“HHMI Indemnitees”), will be indemnified, defended by counsel acceptable to
HHMI, and held harmless by CORPORATION from and against any claim, liability,
cost, expense, damage, deficiency, loss, or obligation, of any kind or nature
(including, without limitation, reasonable attorneys’ fees and other costs and
expenses of defense) (collectively, “HHMI Claims”), based upon, arising out of,
or otherwise relating to this Agreement or any other sublicense, including
without limitation any cause of action relating to product liability. The
previous sentence will not apply to any HHMI Claim that is determined with
finality by a court of competent jurisdiction to result solely from the gross
negligence or willful misconduct of an HHMI Indemnitee. Notwithstanding any
other provision of this Agreement, CORPORATION’s obligation to defend, indemnify
and hold harmless the HHMI Indemnitees under this paragraph will not be subject
to any limitation or exclusion of liability or damages or otherwise limited in
any way.
12.    Insurance.

Exhibit A-12

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

12.01    At such time as any Licensed Product, process or service relating to,
or developed pursuant to, this Agreement is being commercially distributed or
sold or tested in clinical trials by CORPORATION or by a licensee, Affiliate or
agent of CORPORATION, CORPORATION shall at its sole cost and expense, procure
and maintain policies of comprehensive general liability insurance in amounts
not less than (i) [***] during the period that such [***], and (ii) [***] during
the period that such [***] as additional insureds. Such comprehensive general
liability insurance shall provide (i) product liability coverage and (H) broad
form contractual liability coverage for CORPORATION’s indemnification under
Section 11 of this Agreement. If CORPORATION elects to self-insure all or part
of the limits described above (including deductibles or retentions [***]) such
self-insurance program shall include assets or reserves which have been
actuarially determined for the liabilities associated with this Agreement and
must be acceptable to NYU.
The minimum amounts of insurance coverage required under this Section 12 shall
not be construed to create a limit of CORPORATION’s liability with respect to
its indemnification under Section 11 of this Agreement.
12.02    CORPORATION shall provide NYU with written evidence of such insurance
upon request of NYU. If insurance is cancelled, not renewed or a material change
is made to such insurance; if CORPORATION does not obtain replacement insurance
providing comparable coverage within such sixty (60) day period, NYU shall have
the right to terminate this Agreement effective at the end of such sixty (60)
day period without notice or any additional waiting periods.
12.03    CORPORATION shall maintain such comprehensive general liability
insurance beyond the expiration or termination of this Agreement during (i) the
period that any product, process or service, relating to, or developed pursuant
to, this Agreement is being commercially distributed or sold or tested in
clinical trials by CORPORATION or by a sublicensee, Affiliate or agent of
CORPORATION and (H) a reasonable period after the period referred to in (i)
above.
13.    Expiry and Termination
13.01    Unless earlier terminated pursuant to this Section 13 this Agreement
shall expire upon the expiration of the period of the License in all countries
as set forth in Section 5.05 above.
13.02    At any time prior to expiration of this Agreement, either party may
terminate this Agreement forthwith for cause, as “cause” is described below, by
giving written notice to the other party. Cause for termination by one party of
this Agreement shall be deemed to exist if the other party materially breaches
or materially defaults in the performance or observance of any of the provisions
of this Agreement and such breach or default is not cured within sixty (60) days
or, in the case of failure to pay any amounts due hereunder, thirty (30) days
(unless otherwise specified herein) after the giving of notice by the other
party specifying such breach or default, or if either NYU or CORPORATION
discontinues its business or becomes insolvent or bankrupt.
13.03    Upon termination of this Agreement for any reason and prior to
expiration as set forth in Section 13.01 hereof, all rights in and to the
Licensed Technology shall revert to NYU, and CORPORATION shall not be entitled
to make any further use whatsoever of the Licensed Technology; provided, that,
for a period of up to ninety (90) days from the effective date of

Exhibit A-13

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

termination, CORPORATION will have the right to sell any existing inventory of
Licensed Products, subject to its payment of the royalty applicable thereto and
the provision of royalty reports pursuant to Sections 6 and 7.
13.04    In the event that this Agreement is terminated, any granted sublicenses
shall remain in full force and effect and each sublicensee shall become a direct
license of NYU; provided, that, (i) the sublicensee is not then in breach of its
sublicense agreement, (ii) the scope of such sublicensee’s rights with respect
to the Licensed Technology shall remain unchanged and the sublicensee agrees to
be bound to NYU as a licensee under the non-financial terms and conditions of
this Agreement that apply to such scope, and (iii) the sublicensee agrees to pay
to NYU all annual license fees due pursuant to Section 6.01(a) and all amounts
that CORPORATION would have been obligated to pay to NYU under this Agreement as
a result of the activities of such sublicensee.
13.05    Termination of this Agreement shall not relieve either party of any
obligation to the other party incurred prior to such termination.
13.06    Sections 3.01, 3.02, 4.01, 9, 11, 12, 13, 17, 18 and 19.01 hereof shall
survive and remain in full force and effect after any termination, cancellation
or expiration of this Agreement.
Following termination for any reason prior to expiration as set forth in Section
13.01 hereof, should CORPORATION continue to sell Licensed Know-How Products or
develop Licensed Know-How Products after such termination despite Section 13.03
above, in each case where NYU Know-How was used to discover or develop such
Licensed Know-How Product prior to termination but no NYU Know-How is needed to
develop or sell such Licensed Know-How Product after termination, then
termination shall not relieve the CORPORATION from payment of milestones and
royalties in accordance with Sections 6.01(b) and 6.01(c) of this Agreement and
Sections 6.02-6.04 and 7.01-7.03 shall survive and remain in full force and
effect after such termination of this Agreement solely with respect to the
development and sales of such Licensed Know-How Products and solely for the
period of time that such payments would have been owed if the Agreement had not
terminated early. Following termination, royalty reports under clause 6.02 shall
only be due where CORPORATION does in fact sell such Licensed Know-How Products.
13.07    CORPORATION may at any time terminate this Agreement by providing 30
days prior written notice to NYU.
13.08    NYU may terminate this Agreement by providing 30 days prior written
notice to CORPORATION if CORPORATION or its Affiliate institutes a legal
proceeding that challenges the validity of the Licensed Patents.
14.     Representations and Warranties by CORPORATION.
CORPORATION hereby represents and warrants to NYU as follow:
(1)
CORPORATION is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware. CORPORATION has been granted
all requisite power and authority to carry on its business and to

Exhibit A-14

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

own and operate its properties and assets. The execution, delivery and
performance of this Agreement have been duly authorized by the Board of
Directors of CORPORATION.
(2)
There is no pending or, to CORPORATION’s knowledge, threatened litigation
involving CORPORATION which would have an adverse effect on this Agreement or on
CORPORATION’s ability to perform its obligations hereunder; and

(3)
There is no indenture, contract, or agreement to which CORPORATION is a party or
by which CORPORATION is bound which prohibits or would prohibit the execution
and delivery by CORPORATION of this Agreement or the performance or observance
by CORPORATION of any term or condition of this Agreement.

15.    Representations and Warranties by NYU.
NYU hereby represents and warrants to CORPORATION as follows:
(1)
NYU is a corporation duly organized, validly existing and in good standing under
the laws of the State of New York. NYU has been granted all requisite power and
authority to carry on its business and to own and operate its properties and
assets. The execution, delivery and performance of this Agreement have been duly
authorized by the Board of Trustees of NYU.

(2)
There is no pending or, to NYU’s knowledge, threatened litigation involving NYU
which would have any effect on this Agreement or on NYU’s ability to perform its
obligations hereunder; and

(3)
There is no indenture, contract, or agreement to which NYU is a party or by
which NYU is bound which prohibits or would prohibit the execution and delivery
by NYU of this Agreement or the performance or observance by NYU of any term or
condition of this Agreement.

(4)
it is the owner by assignment and/or the co-owner with NIH of all Licensed
Patents listed on Appendix I.A and LB and the inventions described and claimed
therein, and it has the right to grant the licenses to CORPORATION under this
Agreement;

(5)
NYU has not received any notice from any third party that any third party
patent, patent application or other intellectual property rights would be
infringed (i) by practicing any method covered by the Licensed Patents or by
making, using or selling any composition covered by the Licensed Patents, or
(ii) by making, using, offering for sale, selling or importing Licensed
Products; and

Exhibit A-15

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

(6)
NYU is not aware of any infringement or misappropriation by any third party of
the Licensed Patents.

16.    Limitation of Liability.
IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS AFFILIATES OR ANY OF THEIR
RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, MEDICAL AND PROFESSIONAL STAFF,
EMPLOYEES AND AGENTS BE LIABLE TO CORPORATION OR ANY OF ITS AFFILIATES,
SUBLICENSEES OR DISTRIBUTORS FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE
RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
INCLUDING WITHOUT LIMITATION ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST
PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER
REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
17.    No Assignment.
17.01    Neither CORPORATION nor NYU shall have the right to assign, delegate or
transfer at any time to any party, in whole or in part, any or all of the
rights, duties and interest herein granted without first obtaining the written
consent of the other to such assignment, [***].
17.02    NYU hereby consents to [***]. Effective upon such assignment, all
references to CORPORATION in this Agreement shall be deemed, with respect to
time periods after such assignment, to be references to Brickell (or in the
event one or more subsequent assignments pursuant to Section 17.01, the then
current direct or indirect assignee of Brickell). Also effective upon the
assignment from ORCA to Brickell described above, the contact information for
CORPORATION for the purposes of Section 19.05 shall be [***]. Brickell and its
direct and indirect assignees are intended third party beneficiaries of this
Section 17.02.
18.    Use of Name.
18.01    Without the prior written consent of the other party, neither
CORPORATION nor NYU shall use the name of the other party or any adaptation
thereof or of any staff member, employee or student of the other party:
i)
in any product labeling, advertising, promotional or sales literature;

ii)
in connection with any public or private offering or in conjunction with any
application for regulatory approval, unless disclosure is otherwise required by
law, in which case either party may make factual statements concerning the
Agreement or file copies of the Agreement after providing the other party with
an opportunity to comment and reasonable time within which to do so on such
statement in draft.

Exhibit A-16

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

Except as provided herein, neither NYU nor CORPORATION will issue public
announcements about this Agreement without prior written approval of the other
party.
18.02    CORPORATION acknowledges that under HHMI policy, CORPORATION may not
use the name of HHMI or of any HHMI employee ([***]) in a manner that could
constitute an endorsement of a commercial product or service; but that use for
other purposes, even if commercially motivated, is permitted provided that (1)
the use is limited to accurately reporting factual events or occurrences, and
(2) any reference to the name of HHMI or any HHMI employee in press releases or
similar materials intended for public release is approved by HHMI in advance.
19.    Miscellaneous.
19.01    HHMI is not a party to this Agreement and has no liability to any
licensee, sublicensee, or user of anything covered by this Agreement, but HHMI
is an intended third-party beneficiary of this Agreement and certain of its
provisions are for the benefit of HHMI and are enforceable by HHMI in its own
name.
19.02    In carrying out this Agreement the parties shall comply with all local,
state and federal laws and regulations including but not limited to, the
provisions of Title 35 United States Code §200 et seq. and 15 CFR §730-774.
19.03    If any provision of this Agreement is determined to be invalid or void,
the remaining provisions shall remain in effect.
19.04    This Agreement shall be governed by and construed in accordance with
the [***], without regard to principles relating to conflicts of law. The courts
of the [***] shall have exclusive jurisdiction over the parties with respect to
any dispute or controversy between them arising under or in connection with this
Agreement and, by execution and delivery of this Agreement, the parties to this
Agreement submit to the jurisdiction of those courts, including, but not limited
to, the in personam and subject matter jurisdiction of those courts, waive any
objection to such jurisdiction on the grounds of venue or forum non conveniens,
the absence of in personam or subject matter jurisdiction and any similar
grounds, consent to service of process by mail in accordance with paragraph
19.05 or any other manner permitted by law and irrevocably agree to be bound by
any such judgment rendered thereby in connection with this Agreement. These
consents to jurisdiction shall not be deemed to confer rights on any person
other than the parties to this Agreement.
19.05    All payments or notices required or permitted to be given under this
Agreement shall be given in writing and shall be effective when either
personally delivered or deposited, postage prepaid, in the United States
registered or certified mail, or sent via a recognized national overnight
delivery service (such as Federal Express or DHL), addressed as follows:
To NYU:
[***]

 
To CORPORATION:
[***]

Exhibit A-17

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

or such other address or addresses as either party may hereafter specify by
written notice to the other. Such notices and communications shall be deemed
effective on the date of delivery or fourteen (14) days after having been sent
by registered or certified mail, whichever is earlier.
19.06    This Agreement (and the annexed Appendices) constitute the entire
Agreement between the parties and no variation, modification or waiver of any of
the terms or conditions hereof shall be deemed valid unless made in writing and
signed by both parties hereto. This Agreement supersedes any and all prior
agreements or understandings, whether oral or written, between CORPORATION and
NYU.
19.07    No waiver by either party of any non-performance or violation by the
other party of any of the covenants, obligations or agreements of such other
party hereunder shall be deemed to be a waiver of any subsequent violation or
non-performance of the same or any other covenant, agreement or obligation, nor
shall forbearance by any party be deemed to be a waiver by such party of its
rights or remedies with respect to such violation or non-performance.
19.08    The descriptive headings contained in this Agreement are included for
convenience and reference only and shall not be held to expand, modify or aid in
the interpretation, construction or meaning of this Agreement.
19.09    It is not the intent of the parties to create a partnership or joint
venture or to assume partnership responsibility or liability. The obligations of
the parties shall be limited to those set out herein and such obligations shall
be several and not joint.
[Remainder of page intentionally left blank.]

Exhibit A-18

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

IN WITNESS WHEREOF, the parties hereto have executed this Agreement effective as
of the Second License Restatement Effective Date.

19

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Appendix I.A
[***] Patents and Applications
[***]

20

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Appendix I.B
[***] Patent and Patent Applications
[***]

21

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Appendix II
NYU Know-How
[***]

22

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Appendix III
Development Plan
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

Initial plan for selection of lead compound:
1.
[***]

23

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Appendix IV
Inter-Institutional Agreements with NIH

24

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PUBLIC HEALTH SERVICE
PHS INTERINSTITUTIONAL AGREEMENT
INSTITUTION-LEAD
This Agreement is entered into between the National Institutes of Health (“NIH”)
or the Food and Drug Administration (“FDA”), hereinafter singly or collectively
referred to as “PHS”, agencies of the United States Public Health Service within
the Department of Health and Human Services (“HHS”) through the Office of
Technology Transfer, NIH, having an address at 6011 Executive Boulevard, Suite
325, Rockville, Maryland 20852-3804, U.S.A. and New York University School of
Medicine a not for profit education corporation, hereinafter referred to as the
“Institution”, having an address at One Park Avenue, 6th Floor, New York, New
York 10016, U.S.A.
BACKGROUND
1.1
In the course of fundamental research programs at the PHS and by the
Institution, [***], an employee of the Howard Hughes Medical Institute (“HHMI”)
and a faculty member of the Institution, [***] (Institution), [***] (PHS), [***]
(PHS) (Inventor(s)) made or reduced to practice certain inventions which are
included within the Patent Rights, as defined in Paragraph 2.1.

1.2
It is the mutual desire of the Institution and the PHS that their respective
undivided interests in the Patent Rights be administered in a manner to ensure
the rapid commercialization of the Patent Rights and to make their benefits
widely available to the public. Therefore, in accordance with 35 U.S.C. §202(e)
and 37 C.F,R. §401.10, PHS is granting an exclusive license to PHS’ rights in
the Patent Rights to the Institution under the conditions set forth herein.

1.3
The Institution and HHMI are parties to a Collaboration Agreement under which
(i) HHMI employees at the Institution, including [***], assign their rights in
inventions to the Institution, (ii) the Institution seeks patent protection for
such inventions and seeks to license them to companies to be developed into
products to benefit the public, (iii) the Institution shares any revenues from
such licensing with HHMI, and (iv) the Institution grants HHMI a license to such
inventions for its non-commercial purposes, and inserts certain language in
license agreements with companies for HHMI’s benefit.

2.    DEFINITIONS
2.1
“Patent Rights” means:

(a)
Patent applications (including provisional patent applications and PCT patent
applications) or patents as follows: [***];

25

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(b)
[***]:

(i)
[***];

(ii)
[***];

(iii)
[***];

(iv)
[***]; and

(v)
[***]

(c)
[***]; and

(d)
Patent Rights shall [***].

2.2
“Net Revenues” means all consideration received by the Institution [***], less
(a) Expenses and then (b) [***]. It is contemplated that Patent Rights may be
licensed together with other patent rights solely owned by the institution, or
owned jointly by the Institution and a third party. In such instance, the
portion of consideration from such licensing allocated to the Patent Rights
shall be determined on a pro rata basis, based upon the number of patent
families. Payments for the overall license, such as license fees, shall be
allocated based upon the total number of patent families included in the license
at the time the payment was received. Product-specific payments, such as
royalties and milestone payments, shall be allocated based upon the total number
of patent families covering the product generating the payments, at the time the
payment was received.

2.3
“Expenses” means all reasonable and actual out-of-pocket costs, excluding those
reimbursed by a third party, paid by the Institution for the preparation,
filing, prosecution, and licensing of United States and foreign patent
applications, extraordinary expenses as provided in Paragraph 4.6, and the
maintenance of the resulting patents or patent applications, exclusive of any
salaries, administrative, or other indirect costs.

2.4
“Research License” means a nontransferable, nonexclusive license to make and to
use any tangible embodiment of the Patent Rights and to practice any process(es)
included within the Patent Rights for purposes of internal research and not for
purposes of commercial manufacture or distribution or in lieu of purchase.

2.5
“Practical Application” means to manufacture in the case of a composition or
product, to practice in the case of a process or method, or to operate in the
case of a machine or system; and in each case, under such conditions as to
establish that the invention is being utilized and that its benefits are, to the
extent permitted by law or by regulations of the Government of the United States
of America (hereinafter referred to as “Government”), available to the public on
reasonable terms.

26

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3.    GRANT AND RESERVATION OF RIGHTS
3.1
PHS hereby grants and the Institution accepts, subject to the terms and
conditions of this Agreement, an [***].

3.2
The Government shall [***]. Any license granted by the Institution under the
terms of this Agreement shall be subject to [***].

3.3
PHS reserves the right to require the Institution, or its licensees, to [***].

3.4
In addition to the reserved right of Paragraph 3.3, PHS reserves the right to
[***]. The purpose of these [***] is to encourage basic research, whether
conducted at an academic or corporate facility.

3.5
PHS acknowledges that Institution is required to, and that Institution may,
include in any license for the Patent Rights granted by institution provisions
which comply with the HHMI licensing provisions set forth on Appendix B.

4.    PATENT PROSECUTION AND PROTECTION
4.1
The Institution shall file, prosecute, and maintain patent application(s)
relating to the Patent Rights and shall promptly provide to PHS all serial
numbers and filing dates, together with copies of all these applications,
including copies of all Patent Office actions, responses, and all other Patent
Office communications. In addition, the Institution, shall file with Patent
Offices, a Power of Attorney, that names both the Institution and PHS. This
Power of Attorney shall be filed with every Patent Office involved in
prosecuting all patent applications pertaining to Patent Rights. The Institution
shall consult with PHS, when so requested, prior to communicating with any
Patent Office with respect to the Patent Rights.

4.2
The Institution shall make an election with respect to foreign filing, upon
consultation with PHS, including which countries foreign filing shall be done
prior to the election, within eight (8) months of any United States filing. If
any foreign patent applications are filed, the Institution shall promptly
provide to PHS all serial numbers and filing dates. The Institution also shall
provide PITS copies of foreign patent applications and Patent Office actions.
The Institution shall consult with PHS, when so requested, prior to
communication with any Patent Office with respect to the Patent Rights.

4.3
The Institution shall promptly record Assignments of domestic Patent Rights in
the United States Patent and Trademark Office and shall promptly provide PHS
with the original of each recorded Assignment with respect to PHS.

4.4
Notwithstanding any other provision of this Agreement, the Institution shall not
abandon the prosecution of any patent application, including provisional patent
applications (except for purposes of filing continuation application(s)) or the

27

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maintenance of any patent contemplated by this Agreement, without prior written
notice to PHS. Upon receiving the written notice, PHS may, at its sole option,
take over the prosecution of any patent application, or the maintenance of any
patent.
4.5
The Institution shall promptly provide PHS with copies of all issued patents
under this Agreement.

4.6
In the event that the Institution anticipates the possibility of any
extraordinary expenditures arising from the preparation, filing, prosecution,
licensing, or defense of any patent application or patent contemplated by this
Agreement, including, without limitation, interferences, reexaminations,
reissues and oppositions, the Institution shall provide PHS with all relevant
information, and these extraordinary expenditures shall be included as Expenses
only upon written agreement of PHS, provided that if such extraordinary expenses
are necessary to preserve or to avoid abandonment of the Patent Rights, PHS
shall not unreasonably withhold its approval of such extraordinary expenses. The
Institution and PHS shall agree on a mutually acceptable course of action prior
to incurring these expenditures.

5.    LICENSING
5.1
The Institution shall diligently seek licensees for the commercial development
of the Patent Rights and shall administer the Patent Rights for the mutual
benefit of the parties and in the public interest. The Institution shall ensure
that any license granted for the Patent Rights is subject to the provisions of
22 C.F.R. Part 401 mid the rights retained by the Government under this
Agreement, including the requirement for substantial manufacture in the United
States as stated in Paragraph 11.1.

5.2
The Institution [***], notwithstanding any other provision of this Agreement,
without the prior written consent of PHS; provided, however, that PHS hereby
agrees that HHMI [***]. The Institution shall consult with PHS in the
negotiation of [***], notwithstanding any other provision of this Agreement, and
shall not grant these licenses without the prior review, opportunity for
comment, and written approval of PHS.

5.3
Before licensing of the Patent Rights or any part thereof by the Institution,
the Institution shall first notify and confer with PHS regarding any research
funding related to the Patent Rights so as to determine PHS’ interest in
participating in any funded collaborative research project.

5.4
The Institution shall promptly provide PHS with complete copies of all licenses
and sublieenses granted for the Patent Rights.

5.5
Institution agrees that its licensees shall supply, to the Mailing Address for
Agreement notices indicated on the Signature Page, the Office of Technology

28

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Transfer, NIH with inert samples of the licensed products or licensed processes,
as covered by the Patent Rights, or their packaging for educational and display
purposes only.
6.    ROYALTIES AND EXPENSES
6.1
[***].

6.2
All payments to PHS, required under this Agreement, shall be in [***] and
payment options are listed in Appendix A.

(a)
Institution shall submit to MS annual statements of itemized Expenses as defined
in Paragraph 2.3 and shall deduct the Expenses as provided for in Paragraph 2.2,
except where PITS has identified discrepancies in billing by Institution, in
which case, deduction of the contested item(s), as a part of Expenses as
provided for in Paragraph 2.2, from Net Revenues shall be delayed pending
resolution thereof.

6.3
In no event shall PHS be obligated to bear any costs for Expenses under this
Agreement.

6.4
Each party shall be solely responsible for calculating and distributing to its
respective Inventor(s) of the Patent Rights any share of Net Revenues in
accordance with its respective patent policy, royalty policy, or Federal law
during the term of this Agreement.

7.    RECORDS AND REPORTS
7.1
The institution shall keep complete, true, and accurate accounts of all Expenses
and of all Net Revenues received by it from each licensee of the Patent Rights
and shall permit PHS or PHS’ designated agent to examine its books and records
in order to verify the payments due or owed under this Agreement.

7.2
Upon request by PHS, the Institution shall submit to PHS an annual report, not
later than April 1 of each year, setting forth the status of all patent
prosecution, commercial development, and licensing activity relating to the
Patent Rights for the preceding calendar year.

8.    PATENT INFRINGEMENT
8.1
In the event PHS or the Institution, including its licensees, shall learn of the
substantial infringement of any patent subject to this Agreement, the party who
learns of the infringement shall promptly notify the other party in writing and
shall provide the other party with all available evidence of the infringement.
The Institution and its licensees, in cooperation with PHS, shall use their best
efforts to eliminate the infringement without litigation. If the efforts of the
parties are not successful in eliminating the infringement within ninety (90)
days after the

29

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infringer has been formally notified of the infringement by the Institution, the
Institution shall have the right, after consulting with PHS, to commence suit on
its own account or to permit the Institution’s licensee to commence suit on the
licensee’s own account. PITS may join the Institution’s suit or commence its own
suit.
8.2
If neither the Institution nor its licensee (i) bring suit within one (1) year
after the parties arc formally notified of the existence of an infringement, or
(ii) are in negotiations with the infringing party to abate the infringement
within such one (1) year period and either abate the infringement or bring suit
within an additional one (1) year period; then PHS may bring suit to abate the
infringement at PHS’ sole expense.

8.3
Neither a licensee nor the Institution shall take action to compel PHS either to
initiate or to join in any suit for patent infringement. Should the Government
be made a party to any suit by motion or ally other action of a licensee or the
Institution, the licensee or the Institution shall reimburse the Government for
any costs, expenses, or fees which the Government incurs as a result of the
motion or other action, including any and all costs incurred by PHS in opposing
any joinder action.

8.4
Legal action or suits to eliminate infringement or recover damages pursuant to
Paragraph 8.1 shall be at the full expense of the party by whom suit is brought.
All damages recovered thereby shall first be used to reimburse each party for
its expenses relating to the legal action, and the remainder of the damages
shall be considered Net Revenues.

8.5
Each party agrees to cooperate with the other in litigation proceedings. PHS may
be represented, at its expense, by counsel of its choice in any suit.

9.    GOVERNING LAWS. SETTLING DISPUTES
9.1
This Agreement shall be construed in accordance with [***]. Federal law and
regulations shall preempt any conflicting or inconsistent provisions in this
Agreement. The Institution agrees to be subject to the jurisdiction of [***].

9.2
Any controversy or any disputed claim by either party against the other arising
under or related to this Agreement shall be submitted jointly to the
Institution’s President or designee and to the Director of the NIH or designee
for resolution. The Institution and PHS shall be free after written decisions
are issued by those officials to pursue all administrative or judicial remedies
which may be available.

10.    TERM AND TERMINATION
10.1
This Agreement is effective when signed by all parties, unless the provisions of
Paragraph 11.10 are not fulfilled, and shall extend to the expiration of the
last to

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expire of the patents included within the Patent Rights unless otherwise
terminated by operation of law or by acts of the parties in accordance with the
terms of this Agreement.
10.2
The Institution may terminate this Agreement upon at least sixty (60) days
written notice to PHS, but in any event not less than sixty (60) days prior to
the date on which any pending Patent Office actions need be taken to preserve
patent rights for the benefit of the parties hereto.

10.3
In the event the Institution has made no commitments to any third party for
exclusive license rights relating to the Patent Rights, PHS may terminate this
Agreement for any reason upon thirty (30) days written notice to the
Institution. During the term of any option agreement or license agreement to any
third party for exclusive license rights relating to the Patent Rights between
the Institution and an option= or licensee, PHS may terminate this Agreement
when:

(a)
it is determined by PHS’ Office of Technology Transfer that:

(i)
The Institution or its licensee has not taken and is not expected to take
effective steps to achieve Practical Application of the Patent Rights;

(ii)
Termination is necessary to alleviate health or safety needs which are not
reasonably satisfied by the Institution or its licensee;

(iii)
Termination is necessary to meet requirements for public use specified by
Federal law or regulations and these requirements are not reasonably satisfied
by the Institution or its licensees; or

(iv)
Termination is necessary because the requirements of 35 U.S.C. §204 have not
been satisfied or waived or because a licensee of the exclusive right to use or
sell the Patent Rights in the United States is in breach of its agreement
obtained pursuant to Section 204;

(b)
the Institution or affected third party has been notified of this determination
and has been given at least thirty (30) days to provide a response to this
determination, and

(c)
the Institution’s or affected third party’s response to the determination of
10.3(a)(i)-(iv) is determined to be unsatisfactory by the Office of Technology
Transfer.

10,4
PHS may terminate this Agreement in whole or in part if:

(a)
the Institution fails to make any payment or periodic reports required by this
Agreement;

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(b)
the Institution has willfully made a false statement of, or willfully omitted, a
material fact in the negotiation of the Agreement or in any report required by
the Agreement;

(c)
the Institution has committed a substantial breach of a covenant or duty
contained in this Agreement; or

(d)
PHS and the Institution are involved in a dispute under this Agreement which
cannot be resolved under the procedures specified in Paragraph 9.2.

If the Agreement is terminated under this Paragraph 10.4, PHS agrees, subject to
the restrictions of 37 C.F.R. Part 404, that any licenses that have been granted
by the Institution shall remain in effect and Institution obligations to PHS
including, paying royalties shall survive termination of this Agreement.
10.5
Following termination by PHS, PHS shall have no further rights or obligations
under this Agreement, except that the Institution shall be obligated to
administer subsequent gross proceeds from licensing the Patent Rights according
to the Institution policy, and to distribute royalties to PHS for PHS
Inventor(s) as though they were Inventor(s) of the Institution under that policy
with respect to royalties and payment schedules.

11.    GENERAL
11.1
[***].

11.2
All Agreement notices required or permitted by this Agreement shall be given by
prepaid, first class, registered or certified mail or by an express/overnight
delivery service provided by a commercial carrier, properly addressed to the
other party at the address designated on the following Signature Page, or to the
other address as may be designated in writing by such other party. Agreement
notices shall be considered timely if the notices are received on or before the
established deadline date or sent on or before the deadline date as verifiable
by U.S. Postal Service postmark or dated receipt from a commercial carrier.
Parties should request a legibly dated U.S. Postal Service postmark or obtain a
dated receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.

11.3
This Agreement shall not be construed to confer on any person any immunity from
or defenses under the antitrust laws or from a charge of patent misuse, and the
acquisition and use of rights pursuant to this Agreement shall not be immunized
from the operation of state or Federal law by reason of the source of the grant.

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11.4
It is agreed that no waiver by either party hereto of any breach or default of
any of the covenants or agreements herein set forth shall be deemed a waiver as
to any subsequent or similar breach or default.

11.5
This Agreement is binding upon and shall inure to the benefit of the parties
hereto and their successors or assigns, but this Agreement may not be assigned
by either party without the prior written consent of the other party.

11.6
This Agreement confers no license or rights by implication, estoppel, or
otherwise under any patent applications or patents of the PBS other than the
Patent Rights regardless of whether such patents are dominant or subordinate to
the Patent Rights.

11.7
Any modification to this Agreement must be in writing and agreed to by both
parties.

11.8
It is understood and agreed by the Institution and PBS that this Agreement
constitutes the entire agreement between the parties, and that all prior
agreements respecting the subject matter hereof, either written or oral,
expressed or implied, shall be abrogated, canceled, and are null and void and of
no effect.

11.9
HHMI is not a party to this Agreement and has no liability to any party, but
HHMI is an intended third- party beneficiary of this Agreement and certain of
its provisions are for the benefit of HHMI and arc enforceable by HHMI in its
own name.

11.10 The terms and conditions of this Agreement shall, at PHS’ sole option, be
considered by PHS to be withdrawn from Institution’s consideration and the terms
and conditions of this Agreement, and the Agreement itself to be null and void,
unless this Agreement is executed by the Institution and a fully executed
original is received by PHS within sixty (60) days from the date of PHS
signature found at the Signature Page.
SIGNATURES BEGIN ON NEXT PAGE

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PHS INTERINSTITUTIONAL AGREEMENT-- INSTITUTION
SIGNATURE PAGE
IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate
originals by their respective duly authorized officers, who have affixed their
signatures hereunto, on the day and year hereinafter written. Any communication
or notice to be given shall be forwarded to the respective addresses listed
below.
For PHS:
By: /S/ Richard U. Rodriguez         6/9/12            
Richard U. Rodriguez                Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health

Mailing Address or E-mail Address for Agreement notices and reports:

Chief, Monitoring & Enforcement Branch
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.

E-mail: LicenseNotices_Reports@mailmilLgov

For the Institution:

Upon information and belief, the undersigned expressly certifies or affirms that
the contents of any statements of the Institution made or referred to in this
Agreement are truthful and accurate.
By: /s/ Abram M. Goldfinger            6/26/2012            
Signature of Authorized Official    Date

Abram M. Goldfinger
Printed Name

Executive Director Industrial Liaison/Technology Transfer
Title

Official and Mailing Address for Agreement notices:

Abram M. Goldfinger
Printed Name

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Executive Director Industrial Liaison/Technology Transfer
Title

Mailing Address:

New York University
Office of Industrial Liaison
One Park Avenue. 6th Floor,
New York. New York 10016 U.S.A.

Email Address:    abram.goldfinger@nyume.org
Phone:    212-263-8178
Fax:    212-263-8189

And:

Annette Johnson. Esq.
Name

Vice Dean and Senior Counsel for Medical School Affairs
Title

Mailing Address:

550 First Avenue. HCC 15
New York, New York 10016 U.S.A.

Email Address:    annettejohnson@nyumc.org
Phone:    212-263-7921
Fax:    212-263-3235

Official and Mailing Address for Financial notices (Institution’s contact person
for royalty payments)
Abram M. Goldfinger
Name

Executive Director Industrial Liaison/Technology Transfer
Title

Mailing Address:

New York University

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Office of Industrial Liaison
One Park Avenue. 6th Floor,
New York. New York 10016 U.S.A.

Email Address:    abram.goldfinger@nyume.org
Phone:    212-263-8178
Fax:    212-263-8189

Any false or misleading statements made, presented, or submitted to the
Government, including any relevant omissions, under this Agreement and during
the course of negotiation of this Agreement are subject to all applicable civil
and criminal statutes including Federal statutes 31 U.S.C. 03801-3812 (civil
liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or
imprisonment).

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APPENDIX A — ROYALTY PAYMENT OPTIONS
[***]

37

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APPENDIX B — HHMI LICENSING PROVISIONS
Any licenses granted by the Institution under this Agreement shall include the
following HI•IMI licensing provisions, where University shall mean Institution:
1.    Identification of HHMI Investigators
If inventors are named in the license, HHMI investigators and HHMI
inventor/employees should be properly identified as employees of the Howard
Hughes Medical Institute doing research at the HHMI laboratory at the
University.
Example:
The invention was made by Dr. __________, an employee of the Howard Hughes
Medical Institute and a faculty member at the University.

2.    Scope of Rights
HI-IMI requires that the scope of rights in future technology granted under a
license not go beyond the following:
“Patent rights” shall mean and include all of the following intellectual
property of the University:
The United States patents and/or patent applications listed in Appendix A [to
the license]; United States patents issued from the applications listed in
Appendix A and from divisionals and continuations of these applications and any
reissues of such United States patents; claims of continuation-in-part
applications and patents directed to subject matter specifically described in
the applications listed in Appendix A; and claims of all foreign patent
applications, patents, and other intellectual property which are directed to
subject matter specifically described in the United States patents and/or patent
applications listed in Appendix A.
3.    HHMI Research Use License
The license must reflect the fact that HHMI retains an institution-wide,
paid-up, non-exclusive irrevocable license to use the intellectual property for
its research purposes (without the right to sublicense or assign) by including
the following:
Licensee acknowledges that it has been informed that the [licensed technology]
was developed, at least in part, by employees of HHMI and that HHMI has a
paid-up, non-exclusive, irrevocable license to use the [licensed technology] for
HHMI’s research purposes, but with no right to assign or sublicense (the “HHMI
License”). This license is explicitly made subject to the HHMI License.
When exclusive licenses are being negotiated, HHMI’s research tools policies
must be considered. If research tools developed in an HHMI laboratory (including
software) are to be licensed on an exclusive basis, unless otherwise agreed by
IIHMI, HHMI requires that the

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University establish a licensing plan acceptable to HHMI showing how the
research tools will be made available to the research community on reasonably
acceptable terms.
4.    Indemnification
HHMI requires that it and its trustees, officers, employees and agents be
indemnified and held harmless by licensees against claims based on or arising
out of the license. The following is the indemnification provision that MIMI
requires in licenses.
Howard Hughes Medical Institute (“HHMI”), and its trustees, officers, employees,
and agents (collectively, “HHMI Indemnitees”), will be indemnified, defended by
counsel acceptable to HHMI, and held harmless by [the licensee, sublicensee, or
other contracting party] from and against any claim, liability, cost, expense,
damage, deficiency, loss, or obligation, of any kind or nature (including,
without limitation, reasonable attorneys’ fees and other costs and expenses of
defense) (collectively, “Claims”), based upon, arising out of, or otherwise
relating to this [license, sublicense, or other contract or agreement],
including without limitation any cause of action relating to product liability.
The previous sentence will not apply to any Claim that is determined with
finality by a court of competent jurisdiction to result solely from the gross
negligence or willful misconduct of an HHMI Indemnitee.
HIIMI’s indemnification must survive termination indefinitely.
HHMI’s required indemnification language does not provide a right to receive
notice of claims or to settle claims. If the licensee requires the right to
settle claims against HHMI and/or to receive notice of claims, then the
following provisions should be added.
An indemnified party shall provide Licensee with prompt notice of any claim for
which indemnification may be sought pursuant to this Agreement. In the case of
any HHMI Indemnitee, notice shall be given reasonably promptly following actual
receipt of written notice thereof by an officer or attorney of HHMI.
Notwithstanding the foregoing, the delay or failure of [any indemnified party]
[ally HHMI Indemnitee] to give reasonably prompt notice to Licensee of any such
claim shall not affect the rights of such [HHMI Indemnitee] [indemnified party)
unless, and then only to the extent that, such delay or failure is prejudicial
to or otherwise adversely affects Licensee.
Licensee agrees not to settle any Claim against an HHMI Indemnitee without
HHMI’s written consent, where (a) such settlement would include any admission of
liability on the part of any HHMI Indemnitee, (b) such settlement would impose
any restriction oil any HHMI indemnitee’s conduct of any of its activities, or
(c) such settlement would not include an unconditional release of all HHMI
lndemnitees from all liability for claims that are the subject matter of the
settled Claim.
5.    Insurance

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HHMI asks for the same insurance protection as the University receives in any
license. This insurance protection should survive termination.
Licensee shall have the insurance coverage set forth below. Such coverage shall
be purchased from a carrier or carriers having an A. M. Best rating of at least
A- (A minus) and shall name the University and IIHMI as additional insureds.
6.    HHMI Third-Party Beneficiary Status
The license should describe HMI’s status and rights as a third-party beneficiary
as follows:
HHMI is not a party to this Agreement and has no liability to any licensee,
sublicensee, or user of anything covered by this Agreement, but HHMI is an
intended third-party beneficiary of this Agreement and certain of its provisions
are for the benefit of HI1M1 and are enforceable by HHMI in its own name.
7.    Arbitration
HHMI does not permit the provisions in the license governing its rights to be
subject to binding arbitration. Accordingly, if the licensee requires that all
parties submit to binding arbitration, disputes relating to HHMI’s rights must
be carved out of the requirements. The following is model language to exclude
HHMI’s rights from a binding arbitration provision.
Notwithstanding the foregoing, no dispute affecting the rights or property of
HHMI shall be subject to the arbitration provisions set forth above.
8.    Sublicenses
HHMI requires that sublicensces be bound by the obligations in the sections of
the License on indemnification, insurance and HHMI’s third party beneficiary
status, in accordance with the following:
Licensee shall have the right to grant sublicenses consistent with this
Agreement, which sublicenses shall include, without limitation, a provision
binding sublicensees to all terms hereof intended for the protection of the
University and other indemnified parties, including HHMI, against liability or
loss.
9.    Use of Name Provision
The University shall include one of the two following provisions:
LICENSEE acknowledges that under HHMI policy, LICENSEE may not use the name of
HHMI or of any HHMI employee (including Dr. [Investigator Name]) in a manner
that reasonably could constitute an endorsement of a commercial product or
service; but that use for other purposes, even if commercially motivated, is
permitted provided that (1) the use is limited to accurately reporting factual
events or occurrences, and (2) any reference

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to the name of HHMI or any MIMI employees in press releases or similar materials
intended for public release is approved by HHMI in advance.
LICENSEE may use Dr. _____’s name so long as any such usage (i) is limited to
reporting factual events or occurrences only, and (ii) is made in a manner that
could not reasonably constitute an endorsement of LICENSEE or of any LICENSEE
program, product or service. However, LICENSEE shall not use Dr._____’s name or
the Institute’s name in any press release, or quote Dr._____ in any company
materials, or otherwise use Dr. _____’s name or the Institute’s name in a manner
not specifically permitted by the preceding sentence, unless in each case
LICENSEE obtains in advance the written consent of the Institute, and, in the
case of the use of Dr. _____’s name, Dr. _____’s consent as well.

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PUBLIC HEALTH SERVICE
PITS INTERINSTITUTIONAL AGREEMENT
INSTITUTION-LEAD
This Agreement is entered into between the National Institutes of Health (“NIH”)
or the Food and Drug Administration (“FDA”), hereinafter singly or collectively
referred to as “PHS”, agencies of the United States Public Health Service within
the Department of Health and Human Services (“HHS”) through the Office of
Technology Transfer, NIH, having an address at 6011 Executive Boulevard, Suite
325, Rockville, Maryland 20852-3804, U.S.A. and New York University School of
Medicine a not for profit education corporation, hereinafter referred to as the
“Institution”, having an address at One Park Avenue, 61h Floor, New York, New
York 10016, U.S.A.
BACKGROUND
1.1
In the course of fundamental research programs at the PHS and by the
Institution, [***], an employee of the Howard Hughes Medical Institute (“HHMI”)
and a faculty member of the Institution, [***] (Institution), [***] (PHS), [***]
(PHS) and [***] (PHS) (Inventor(s)) made or reduced to practice certain
inventions which are included within the Patent Rights, as defined in Paragraph
2.1.

1.2
It is the mutual desire of the Institution and the PHS that their respective
undivided interests in the Patent Rights be administered in a manner to ensure
the rapid commercialization of the Patent Rights and to make their benefits
widely available to the public. Therefore, in accordance with 35 U.S.C, §202(e)
and 37 C.F.R. §401.10, PHS is granting an exclusive license to PHS’ rights in
the Patent Rights to the Institution under the conditions set forth herein.

1.3
The Institution and HHMI are parties to a Collaboration Agreement under which
(i) HHMI employees at the Institution, including Daniel Littman, assign their
rights in inventions to the institution, (ii) the institution seeks patent
protection for such inventions and seeks to license them to companies to be
developed into products to benefit the public, (iii) the Institution shares any
revenues from such licensing with HHMI, and (iv) the Institution grants HHMI a
license to such inventions for its non-commercial purposes, and inserts certain
language in license agreements with companies for HHMI’s benefit.

2.    DEFINITIONS
2.1
“Patent Rights” means:

(a)
[***];

(b)
[***]:

(i)
[***];

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(ii)
[***];

(iii)
[***];

(iv)
[***]; and

(v)
[***]

(c)
[***]; and

(d)
[***].

2.2
“Net Revenues” means all consideration received by the institution from the
licensing of the Patent Rights pursuant to this Agreement, less (a) Expenses and
then [***] It is contemplated that Patent Rights may be licensed together with
other patent rights solely owned by the institution, or owned jointly by the
Institution and a third party. In such instance, the portion of consideration
from such licensing allocated to the Patent Rights shall be determined on a pro
rata basis, based upon the number of patent families. Payments for the overall
license, such as license fees, shall be allocated based upon the total number of
patent families included in the license at the time the payment was received.
[***]

2.3
“Expenses” means all reasonable and actual out-of-pocket costs, excluding those
reimbursed by a third party, paid by the Institution for the preparation,
filing, prosecution, and licensing of United States and foreign patent
applications, extraordinary expenses as provided in Paragraph 4.6, and the
maintenance of the resulting patents or patent applications, exclusive of any
salaries, administrative, or other indirect costs.

2.4
“Research License” means a [***]

2.5
“Practical Application” means to manufacture in the case of a composition or
product, to practice in the case of a process or method, or to operate in the
case of a machine or system; and in each case, under such conditions as to
establish that the invention is being utilized and that its benefits arc, to the
extent permitted by law or by regulations of the Government of the United States
of America (hereinafter referred to as “Government”), available to the public on
reasonable terms.

3.    GRANT AND RESERVATION OF RIGHTS
3.1
PHS hereby grants and the Institution accepts, subject to the terms and
conditions of this Agreement, [***].

3.2
The Government shall have the [***]. Any license granted by the Institution
under the terms of this Agreement shall be subject to this right of the
Government.

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3.3
PHS reserves the right to require the Institution, or its licensees, to grant
sublicenses to responsible applicants, on terms that arc reasonable under the
circumstances when necessary to RIM]] health or safety needs or when necessary
to meet requirements for public use specified by Federal regulations.

3.4
in addition to the reserved right of Paragraph 3.3, PHS [***]

3.5
PHS acknowledges that Institution is required to, and that Institution may,
include in any license for the Patent Rights granted by Institution provisions
which comply with the HHMI licensing provisions set forth on Appendix B.

4.    PATENT PROSECUTION AND PROTECTION
4.1
The Institution shall file, prosecute, and maintain patent application(s)
relating to the Patent Rights and shall promptly provide to PHS all serial
numbers and filing dates, together with copies of all these applications,
including copies of all Patent Office actions, responses, and all other Patent
Office communications. In addition, the Institution, shall file with Patent
Offices, a Power of Attorney, that names both the institution and PHS. This
Power of Attorney shall be filed with every Patent Office involved in
prosecuting all patent applications pertaining to Patent Rights. The Institution
shall consult with PHS, when so requested, prior to communicating with any
Patent Office with respect to the Patent Rights.

4.2
The Institution shall make an election with respect to foreign filing, upon
consultation with PHS, including which countries foreign filing shall be done
prior to the election, within eight (8) months of any United States filing. If
any foreign patent applications are filed, the Institution shall promptly
provide to PHS all serial numbers and filing dates. The Institution also shall
provide PHS copies of foreign patent applications and Patent Office actions. The
Institution shall consult with PHS, when so requested, prior to communication
with any Patent Office with respect to the Patent Rights.

4.3
The Institution shall promptly record Assignments of domestic Patent Rights in
the United States Patent and Trademark Office and shall promptly provide PHS
with the original of each recorded Assignment with respect to PHS.

4.4
Notwithstanding any other provision of this Agreement, the Institution shall not
abandon the prosecution of any patent application, including provisional patent
applications (except for purposes of filing continuation application(s)) or the
maintenance of any patent contemplated by this Agreement, without prior written
notice to PHS. Upon receiving the written notice, PHS may, at its sole option,
take over the prosecution of any patent application, or the maintenance of any
patent.

4.5
The institution shall promptly provide PHS with copies of all issued patents
under this Agreement.

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4.6
In the event that the Institution anticipates the possibility of any
extraordinary expenditures arising from the preparation, filing, prosecution,
licensing, or defense of any patent application or patent contemplated by this
Agreement, including, without limitation, interferences, reexaminations,
reissues and oppositions, the Institution shall provide PHS with all relevant
information, and these extraordinary expenditures shall be included as Expenses
only upon written agreement of PHS, provided that if such extraordinary expenses
are necessary to preserve or to avoid abandonment of the Patent Rights, PHS
shall not unreasonably withhold its approval of such extraordinary expenses. The
Institution and PHS shall agree on a mutually acceptable course of action prior
to incurring these expenditures.

5.    LICENSING
5.1
The Institution shall diligently seek licensees for the commercial development
of the Patent Rights and shall administer the Patent Rights for the mutual
benefit of the parties and in the public interest. The Institution shall ensure
that any license granted for the Patent Rights is subject to the provisions of
37 C.F.R. Part 401 and the rights retained by the Government under this
Agreement, including the requirement for substantial manufacture in the United
States as stated in Paragraph 11.1.

5.2
The Institution shall [***] notwithstanding any other provision of this
Agreement, without the prior written consent of PHS; provided, however, that PHS
hereby agrees that [***] The Institution shall consult with PHS [***],
notwithstanding any other provision of this Agreement, and shall not grant these
licenses without the prior review, opportunity for comment, and written approval
of PHS.

5.3
Before licensing of the Patent Rights or any part thereof by the Institution,
the Institution shall first notify and confer with PHS regarding any research
funding related to the Patent Rights so as to determine PHS’ interest in
participating in any funded collaborative research project.

5.4
The Institution shall promptly provide PHS with complete copies of all licenses
and sublicenses granted for the Patent Rights.

5.5
Institution agrees that its licensees shall supply, to the Mailing Address for
Agreement notices indicated on the Signature Page, the Office of Technology
Transfer, NIH with inert samples of the licensed products or licensed processes,
as covered by the Patent Rights, or their packaging for educational and display
purposes only.

6.    ROYALTIES AND EXPENSES
6.1
[***]

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6.2
All payments to PHS, required under this Agreement, shalt be in U.S. dollars and
payment options are listed in Appendix A.

6.3
Institution shall submit to PUS annual statements of itemized Expenses as
defined in Paragraph 2.3 and shall deduct the Expenses as provided for in
Paragraph 2.2, except where PHS has identified discrepancies in billing by
Institution, in which case, deduction of the contested item(s), as a part of
Expenses as provided for in Paragraph 2.2, from Net Revenues shall be delayed
pending resolution thereof.

6.4
in no event shall PUS be obligated to bear any costs for Expenses under this
Agreement.

6.5
Each party shall be solely responsible for calculating and distributing to its
respective Inventor(s) of the Patent Rights any share of Net Revenues in
accordance with its respective patent policy, royalty policy, or Federal law
during the term of this Agreement.

7.    RECORDS AND REPORTS
7.1
The Institution shall keep complete, true, and accurate accounts of all Expenses
and of all Net Revenues received by it from each licensee of the Patent Rights
and shall permit PHS or PHS’ designated agent to examine its books and records
in order to verify the payments due or owed under this Agreement.

7.2
Upon request by PHS, the Institution shall submit to PHS an animal report, not
later than April 1 of each year, setting forth the status of all patent
prosecution, commercial development, and licensing activity relating to the
Patent Rights for the preceding calendar year.

8.    PATENT INFRINGEMENT
8.1
In the event PHS or the Institution, including its licensees, shall learn of the
substantial infringement of any patent subject to this Agreement, the party who
learns of the infringement shall promptly notify the other party in writing and
shall provide the other party with all available evidence of the infringement.
The Institution and its licensees, in cooperation with PHS, shall use their best
efforts to eliminate the infringement without litigation. If the efforts of the
parties are not successful in eliminating the infringement within ninety (90)
days after the infringer has been formally notified of the infringement by the
Institution, the Institution shall have the right, after consulting with PHS, to
commence suit on its own account or to permit the Institution’s licensee to
commence suit on the licensee’s own account. PHS may join the Institution’s suit
or commence its own suit.

8.2
If neither the Institution nor its licensee (i) bring suit within one (I) year
after the parties are formally notified of the existence of an infringement, or
(ii) are in

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negotiations with the infringing party to abate the infringement within such one
(I) year period and either abate the infringement or bring suit within an
additional one (1) year period; then PHS may bring suit to abate the
infringement at PUS’ sole expense.
8.3
Neither a licensee nor the Institution shall take action to compel PHS either to
initiate or to join in any suit for patent infringement. Should the Government
be made a party to any suit by motion or any other action of a licensee or the
institution, the licensee or the Institution shall reimburse the Government for
any costs, expenses, or fees which the Government incurs as a result of the
motion or other action, including any and all costs incurred by PHS in opposing
any joinder action.

8.4
Legal action or suits to eliminate infringement or recover damages pursuant to
Paragraph 8.1 shall be at the full expense of the party by whom suit is brought.
All damages recovered thereby shall first be used to reimburse each party for
its expenses relating to the legal action, and the remainder of the damages
shall be considered Net Revenues.

8.5
Each party agrees to cooperate with the other in litigation proceedings. PHS may
be represented, at its expense, by counsel of its choice in any suit.

9.    GOVERNING LAWS, SETTLING DISPUTES
9.1
This Agreement shall be construed in accordance with [***], as interpreted and
applied [***]. Federal law and regulations shall preempt any conflicting or
inconsistent provisions in this Agreement. The Institution agrees to be subject
to the [***].

9.2
Any controversy or any disputed claim by either party against the other arising
under or related to this Agreement shall be submitted jointly to the
Institution’s President or designee and to the Director of the NIH or designee
for resolution. The Institution and PHS shall be free after written decisions
arc issued by those officials to pursue all administrative or judicial remedies
which may be available.

10.    TERM AND TERMINATION
10.1
This Agreement is effective when signed by all parties, unless the provisions of
Paragraph 11.10 are not fulfilled, and shall extend to the expiration of the
last to expire of the patents included within the Patent Rights unless otherwise
terminated by operation of law or by acts of the parties in accordance with the
terms of this Agreement.

10.2
The Institution may terminate this Agreement upon at least sixty (60) days
written notice to PHS, but in any event not less than sixty (60) days prior to
the date on

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which any pending Patent Office actions need be taken to preserve patent rights
for the benefit of the parties hereto.
10.3
In the event the institution has made no commitments to any third party for
exclusive license rights relating to the Patent Rights, PHS may terminate this
Agreement for any reason upon thirty (30) days written notice to the
Institution. During the term of any option agreement or license agreement to any
third party for exclusive license rights relating to the Patent Rights between
the Institution and an optionee or licensee, MS may terminate this Agreement
when:

(a)
it is determined by PHS’ Office of Technology Transfer that:

(i)
The Institution or its licensee has not taken and is not expected to take
effective steps to achieve Practical Application of the Patent Rights;

(ii)
Termination is necessary to alleviate health or safety needs which are not
reasonably satisfied by the Institution or its licensee;

(iii)
Termination is necessary to meet requirements for public use specified by
Federal law or regulations and these requirements are not reasonably satisfied
by the Institution or its licensees; or

(iv)
Termination is necessary because the requirements of 35 U.S.C. §204 have not
been satisfied or waived or because a licensee of the exclusive right to use or
sell the Patent Rights in the United States is in breach of its agreement
obtained pursuant to Section 204; the Institution or affected third party has
been notified of this determination and has been given at least thirty (30) days
to provide a response to this determination, and the institution’s or affected
third party’s response to the determination of 10.3(a)(i)-(iv) is determined to
be unsatisfactory by the Office of Technology Transfer.

10.4
PHS may terminate this Agreement in whole or in part if:

(a)
the Institution fails to make any payment or periodic reports required by this
Agreement;

(b)
the Institution has willfully made a false statement of, or willfully omitted, a
material fact in the negotiation of the Agreement or in any report required by
the Agreement;

(C)
the Institution has committed a substantial breach of a covenant or duty
contained in this Agreement; or

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(d)
PHS and the Institution are involved in a dispute under this Agreement which
cannot be resolved under the procedures specified in Paragraph 9.2.

If the Agreement is terminated under this Paragraph 10.4, PHS agrees, subject to
the restrictions of 37 C,F,R. Part 404, that any licenses that have been granted
by the Institution shall remain in effect and Institution obligations to PHS
including, paying royalties shall survive termination of this Agreement.
10.5
Following termination by PHS, PHS shall have no further rights or obligations
under this Agreement, except that the Institution shall be obligated to
administer subsequent gross proceeds from licensing the Patent Rights according
to the Institution policy, and to distribute royalties to PHS for PHS
Inventor(s) as though they were Inventor(s) of the Institution under that policy
with respect to royalties and payment schedules.

II.    GENERAL
11.1
The Institution agrees that, for use and sale of the Patent Rights in the United
States, any products embodying the Patent Rights, or produced through use of the
Patent Rights, shall be manufactured substantially in the United States unless a
waiver is granted by PHS.

11.2
All Agreement notices required or permitted by this Agreement shall be given by
prepaid, first class, registered or certified mail or by an express/overnight
delivery service provided by a commercial carrier, properly addressed to the
other party at the address designated on the following Signature Page, or to the
other address as may be designated in writing by such other party. Agreement
notices shall be considered timely if the notices are received on or before the
established deadline date or sent on or before the deadline date as verifiable
by U.S. Postal Service postmark or dated receipt from a commercial carrier.
Parties should request a legibly dated U.S. Postal Service postmark or obtain a
dated receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.

11.3
This Agreement shall not be construed to confer on any person any immunity from
or defenses under the antitrust laws or from a charge of patent misuse, and the
acquisition and use of rights pursuant to this Agreement shall not be immunized
from the operation of state or Federal law by reason of the source of the grant.

11.4
It is agreed that no waiver by either party hereto of any breach or default of
any of the covenants or agreements herein set forth shall be deemed a waiver as
to any subsequent or similar breach or default.

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11.5
This Agreement is binding upon and shall inure to the benefit of the parties
hereto and their successors or assigns, but this Agreement may not be assigned
by either party without the prior written consent of the other party.

11.6
This Agreement confers no license or rights by implication, estoppel, or
otherwise under any patent applications or patents of the PHS other than the
Patent Rights regardless of whether such patents are dominant or subordinate to
the Patent Rights.

11.7
Any modification to this Agreement must be in writing and agreed to by both
parties.

11.8
It is understood and agreed by the institution and PHS that this Agreement
constitutes the entire agreement between the parties, and that all prior
agreements respecting the subject matter hereof, either written or oral,
expressed or implied, shall be abrogated, canceled, and arc null and void and of
no effect.

1!.9
HHMI is not a party to this Agreement and has no liability to any party, but
HHMI is an intended third-party beneficiary of this Agreement and certain of its
provisions arc for the benefit of HHMI and are enforceable by HHMI in its own
name.

11.10
The terms and conditions of this Agreement shall, at PHS’ sole option, be
considered by PHS to be withdrawn from Institution’s consideration and the terms
and conditions of this Agreement, and the Agreement itself to be null and void,
unless this Agreement is executed by the Institution and a fully executed
original is received by PHS within sixty (60) days from the date of PHS
signature found at the Signature Page.

SIGNATURES BEGIN ON NEXT PAGE

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PHS INTERINSTITUTIONAL AGREEMENT-- INSTITUTION
SIGNATURE PAGE
IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate
originals by their respective duly authorized officers, who have affixed their
signatures hereunto, on the day and year hereinafter written. Any communication
or notice to be given shall be forwarded to the respective addresses listed
below.
For PHS:
/s/ Richard U. Rodriguez            7/20/12            
Richard U. Rodriguez    Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health

Mailing Address or E-mail Address for Agreement notices and reports:

Chief, Monitoring & Enforcement Branch
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.

E-mail: LicenseNotices_Reports@mailmilLgov

For the Institution:

Upon information and belief, the undersigned expressly certifies or affirms that
the contents of any statements of the Institution made or referred to in this
Agreement are truthful and accurate.
/s/ Abram M. Goldfinger            7/23/12            
Signature of Authorized Official    Date

Abram M. Goldfinger
Printed Name

Executive Director Industrial Liaison/Technology Transfer
Title

Official and Mailing Address for Agreement notices:

Abram M. Goldfinger
Printed Name

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Executive Director Industrial Liaison/Technology Transfer
Title

Mailing Address:

New York University
Office of Industrial Liaison
One Park Avenue. 6th Floor,
New York. New York 10016 U.S.A.

Email Address:    abram.goldfinger@nyume.org
Phone:    212-263-8178
Fax:    212-263-8189

And:

Annette Johnson. Esq.
Name

Vice Dean and Senior Counsel for Medical School Affairs
Title

Mailing Address:

550 First Avenue. HCC 15
New York, New York 10016 U.S.A.

Email Address:    annettejohnson@nyumc.org
Phone:    212-263-7921
Fax:    212-263-3235

Official and Mailing Address for Financial notices (Institution’s contact person
for royalty payments)
Abram M. Goldfinger
Name

Executive Director Industrial Liaison/Technology Transfer
Title

Mailing Address:

New York University

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Office of Industrial Liaison
One Park Avenue. 6th Floor,
New York. New York 10016 U.S.A.

Email Address:    abram.goldfinger@nyume.org
Phone:    212-263-8178
Fax:    212-263-8189

Any false or misleading statements made, presented, or submitted to the
Government, including any relevant omissions, under this Agreement and during
the course of negotiation of this Agreement are subject to all applicable civil
and criminal statutes including Federal statutes 31 U.S.C. 03801-3812 (civil
liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or
imprisonment).

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APPENDIX A — ROYALTY PAYMENT OPTIONS
[***]

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APPENDIX B — HHMI LICENSING PROVISIONS
Any licenses granted by the Institution under this Agreement shall include the
following HI•IMI licensing provisions, where University shall mean Institution:
1.    Identification of HHMI Investigators
If inventors are named in the license, HHMI investigators and HHMI
inventor/employees should be properly identified as employees of the Howard
Hughes Medical Institute doing research at the HHMI laboratory at the
University.
Example:
The invention was made by Dr. __________, an employee of the Howard Hughes
Medical Institute and a faculty member at the University.

2.    Scope of Rights
HHMI requires that the scope of rights in future technology granted under a
license not go beyond the following:
“Patent rights” shall mean and include all of the following intellectual
property of the University:
The United States patents and/or patent applications listed in Appendix A [to
the license]; United States patents issued from the applications listed in
Appendix A and from divisionals and continuations of these applications and any
reissues of such United States patents; claims of continuation-in-part
applications and patents directed to subject matter specifically described in
the applications listed in Appendix A; and claims of all foreign patent
applications, patents, and other intellectual property which are directed to
subject matter specifically described in the United States patents and/or patent
applications listed in Appendix A.
3.    HHMI Research Use License
The license must reflect the fact that HHMI retains an institution-wide,
paid-up, non-exclusive irrevocable license to use the intellectual property for
its research purposes (without the right to sublicense or assign) by including
the following:
Licensee acknowledges that it has been informed that the [licensed technology]
was developed, at least in part, by employees of HHMI and that HHMI has a
paid-up, non-exclusive, irrevocable license to use the [licensed technology] for
IIHMI’s research purposes, but with no right to assign or sublicense (the “HHMI
License”). This license is explicitly made subject to the HHMI License.
When exclusive licenses are being negotiated, HHMI’s research tools policies
must be considered. If research tools developed in an HHMI laboratory (including
software) are to be licensed on an exclusive basis, unless otherwise agreed by
HHMI, HHMI requires that the

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University establish a licensing plan acceptable to HHMI showing how the
research tools will be made available to the research community on reasonably
acceptable terms.
4.    Indemnification
HHMI requires that it and its trustees, officers, employees and agents be
indemnified and held harmless by licensees against claims based on or arising
out of the license. The following is the indemnification provision that HHMI
requires in licenses.
Howard Hughes Medical Institute (“HHMI”), and its trustees, officers, employees,
and agents (collectively, “HHMI Indemnitees”), will be indemnified, defended by
counsel acceptable to HHMI, and held harmless by [the licensee, sublicensee, or
other contracting party] from and against any claim, liability, cost, expense,
damage, deficiency, loss, or obligation, of any kind or nature (including,
without limitation, reasonable attorneys’ fees and other costs and expenses of
defense) (collectively, “Claims”), based upon, arising out of, or otherwise
relating to this [license, sublicense, or other contract or agreement],
including without limitation any cause of action relating to product liability.
The previous sentence will not apply to any Claim that is determined with
finality by a court of competent jurisdiction to result solely from the gross
negligence or willful misconduct of an HHMI Indemnitee.
HIIMI’s indemnification must survive termination indefinitely.
HHMI’s required indemnification language does not provide a right to receive
notice of claims or to settle claims. If the licensee requires the right to
settle claims against HHMI and/or to receive notice of claims, then the
following provisions should be added.
An indemnified party shall provide Licensee with prompt notice of any claim for
which indemnification may be sought pursuant to this Agreement. In the case of
any HHMI Indemnitee, notice shall be given reasonably promptly following actual
receipt of written notice thereof by an officer or attorney of HHMI.
Notwithstanding the foregoing, the delay or failure of [any indemnified party]
[ally HHMI Indemnitee] to give reasonably prompt notice to Licensee of any such
claim shall not affect the rights of such [HHMI Indemnitee] [indemnified party)
unless, and then only to the extent that, such delay or failure is prejudicial
to or otherwise adversely affects Licensee.
Licensee agrees not to settle any Claim against an HHMI Indemnitee without
HHMI’s written consent, where (a) such settlement would include any admission of
liability on the part of any HHMI Indemnitee, (b) such settlement would impose
any restriction oil any HHMI indemnitee’s conduct of any of its activities, or
(c) such settlement would not include an unconditional release of all IIHM1
lndemnitees from all liability for claims that are the subject matter of the
settled Claim.
5.    Insurance

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HHMI asks for the same insurance protection as the University receives in any
license. This insurance protection should survive termination.
Licensee shall have the insurance coverage set forth below. Such coverage shall
be purchased from a carrier or carriers having an A. M. Best rating of at least
A- (A minus) and shall name the University and IIHMI as additional insureds.
6.    HHMI Third-Party Beneficiary Status
The license should describe HMI’s status and rights as a third-party beneficiary
as follows:
HHMI is not a party to this Agreement and has no liability to any licensee,
sublicensee, or user of anything covered by this Agreement, but HHMI is an
intended third-party beneficiary of this Agreement and certain of its provisions
are for the benefit of HI1M1 and are enforceable by HHMI in its own name.
7.    Arbitration
HHMI does not permit the provisions in the license governing its rights to be
subject to binding arbitration. Accordingly, if the licensee requires that all
parties submit to binding arbitration, disputes relating to HHMI’s rights must
be carved out of the requirements. The following is model language to exclude
HHMI’s rights from a binding arbitration provision.
Notwithstanding the foregoing, no dispute affecting the rights or property of
HHMI shall be subject to the arbitration provisions set forth above.
8.    Sublicenses
HHMI requires that sublicensces be bound by the obligations in the sections of
the License on indemnification, insurance and HHMI’s third party beneficiary
status, in accordance with the following:
Licensee shall have the right to grant sublicenses consistent with this
Agreement, which sublicenses shall include, without limitation, a provision
binding sublicensees to all terms hereof intended for the protection of the
University and other indemnified parties, including HHMI, against liability or
loss.
9.    Use of Name Provision
The University shall include one of the two following provisions:
LICENSEE acknowledges that under HHMI policy, LICENSEE may not use the name of
HHMI or of any HHMI employee (including Dr. [Investigator Name]) in a manner
that reasonably could constitute an endorsement of a commercial product or
service; but that use for other purposes, even if commercially motivated, is
permitted provided that (1) the use is limited to accurately reporting factual
events or occurrences, and (2) any reference

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to the name of HHMI or any MIMI employees in press releases or similar materials
intended for public release is approved by HHMI in advance.
LICENSEE may use Dr. _____’s name so long as any such usage (i) is limited to
reporting factual events or occurrences only, and (ii) is made in a manner that
could not reasonably constitute an endorsement of LICENSEE or of any LICENSEE
program, product or service. However, LICENSEE shall not use Dr._____’s name or
the Institute’s name in any press release, or quote Dr._____ in any company
materials, or otherwise use Dr. _____’s name or the Institute’s name in a manner
not specifically permitted by the preceding sentence, unless in each case
LICENSEE obtains in advance the written consent of the Institute, and, in the
case of the use of Dr. _____’s name, Dr. _____’s consent as well.

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THE NATIONAL INSTITUTES OF HEALTH
INTERINSTITUTIONAL AGREEMENT
INSTITUTION-LEAD
This Agreement is entered into between the National Institutes of Health (“NIH”)
within the Department of Health and Human Services (“HHS”) through the Office of
Technology Transfer, NIH, having an address at 6011 Executive Boulevard, Suite
325, Rockville, Maryland 20852-3804, U.S.A and New York University School of
Medicine, a not for profit education corporation, hereinafter referred to as the
“Institution”, having an address at One Park Avenue, 6th Floor, New York, New
York 10016, U.S.A.
I.    BACKGROUND
1.1
In the course of fundamental research programs at the NIH or at the Food and
Drug Administration and by the Institution, [***], an employee of the Howard
Hughes Medical Institute (“HHMI”) and a faculty member of the Institution, [***]
(Institution), [***] (NM), [***] (NIH) and [***] (NIH) (Inventor(s)) made or
reduced to practice certain inventions which are included within the Patent
Rights, as defined in Paragraph 2.1.

1.2
It is the mutual desire of the Institution and the NIH that their respective
undivided interests in the Patent Rights be administered in a manner to ensure
the rapid commercialization of the Patent Rights and to make their benefits
widely available to the public. Therefore, in accordance with 35 U.S.C. .§202(el
and 37 C.F.R. §401.10, the NIH [***] under the conditions set forth herein.

1.3
The Institution and HHMI are parties to a Collaboration Agreement under which
(i) HHMI employees at the Institution, including Daniel Littman, assign their
rights in inventions to the Institution, (ii) the Institution seeks patent
protection for such inventions and seeks to license them to companies to be
developed into products to benefit the public, (iii) the Institution shares any
revenues from such licensing with HHMI, and (iv) the Institution grants HHMI a
license to such inventions for its non-commercial purposes, and inserts certain
language in license agreements with companies for HHMI’s benefit.

2.    DEFINITIONS
2.1
“Government” means the government of the United States of America.

2.2
“FDA” means the Food and Drug Administration.

2.3
“Patent Rights” means:

(a)
[***]

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(i)
[***], and

(ii)
[***];

(b)
[***]:

(i)
[***];

(ii)
[***];

(iii)
[***];

(iv)
[***]; and

(v)
[***]

(c)
to the extent that the following contain one or more claims directed to the
invention or inventions disclosed in 2.3(a) and to the extent that at least one
Inventor from the Institution and at least one Inventor from the NIH are
Inventors: all counterpart foreign and U.S. patent applications and patents to
2.3(a) and 2.3(b); and

(d)
Patent Rights shall not include 2.3(b) or 2.3(c) to the extent that they contain
one or more claims directed to new matter which is not the subject matter
disclosed in 2.3(a).

2.4
“Net Revenues” means all consideration received by the Institution from the
licensing of the Patent Rights pursuant to this Agreement less (a) Expenses and
then (b) [***]. It is contemplated that Patent Rights may be licensed together
with other patent rights solely owned by the Institution, or owned jointly by
the Institution and a third party. In such instance, the [***]

2.5
“Expenses” means all reasonable and actual out-of-pocket costs, excluding those
reimbursed by a third party, paid by the Institution for the preparation,
filing, prosecution, and licensing of United States and foreign patent
applications, extraordinary expenses as provided in Paragraph 4.6, and the
maintenance of the resulting patents or patent applications, exclusive of any
salaries, administrative, or other indirect costs.

2.6
“Research License” means [***].

2.7
“Practical Application” means to manufacture in the case of a composition or
product, to practice in the case of a process or method, or to operate in the
case of a machine or system; and in each case, under such conditions as to
establish that the invention is being utilized and that its benefits are, to the
extent permitted by law or by regulations of the Government, available to the
public on reasonable terms.

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3.    GRANT AND RESERVATION OF RIGHTS
3.1
The NIH hereby grants and the Institution accepts, subject to the terms and
conditions of this Agreement, [***].

3.2
The Government shall [***]. Any license granted by the Institution under the
terms of this Agreement shall be subject to this right of the Government.

3.3
The NIH reserves the right to require the Institution, or its licensees, to
grant sublicenses to responsible applicants, on terms that are reasonable under
the circumstances when necessary to fulfill health or safety needs or when
necessary to meet requirements for public use specified by Federal regulations.

3.4
In addition to the reserved right of Paragraph 3.3, the NIH reserves the right
to require the Institution to grant Research Licenses on reasonable terms and
conditions. The purpose of these Research Licenses is to encourage basic
research, whether conducted at an academic or corporate facility.

3.5
The NIH acknowledges that Institution is required to, and that Institution may,
include in any license for the Patent Rights granted by Institution provisions
which comply with the HHMI licensing provisions set forth on Appendix B.

4.    PATENT PROSECUTION AND PROTECTION
4.1
The Institution shall file, prosecute, and maintain patent application(s)
relating to the Patent Rights and shall promptly provide to the NIH all serial
numbers and filing dates, together with copies of all these applications,
including copies of all Patent Office actions, responses, and all other Patent
Office communications. In addition, the Institution, shall file with Patent
Offices, a Power of Attorney, that names both the Institution and the NIH. This
Power of Attorney shall be filed with every Patent Office involved in
prosecuting all patent applications pertaining to Patent Rights. The Institution
shall consult with the NIH, when so requested, prior to communicating with any
Patent Office with respect to the Patent Rights.

4.2
The Institution shall make an election with respect to foreign filing, upon
consultation with the NIH, including which countries foreign filing shall be
done prior to the election, within eight (8) months of any United States filing.
If any foreign patent applications are filed, the Institution shall promptly
provide to the NIH all serial numbers and filing dates. The Institution also
shall provide the NIH copies of foreign patent applications and Patent Office
actions. The Institution shall consult with the NIH, when so requested, prior to
communication with any Patent Office with respect to the Patent Rights.

4.3
The Institution shall promptly record Assignments of domestic Patent Rights in
the United States Patent and Trademark Office and shall promptly provide the NIH
with the original of each recorded Assignment with respect to the NIH.

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4.4
Notwithstanding any other provision of this Agreement, the Institution shall not
abandon the prosecution of any patent application, including provisional patent
applications (except for purposes of filing continuation application(s)) or the
maintenance of any patent contemplated by this Agreement, without prior written
notice to the NIH. Upon receiving the written notice, the NIH may, at its sole
option, take over the prosecution of any patent application, or the maintenance
of any patent.

4.5
The Institution shall promptly provide the NIH with copies of all issued patents
under this Agreement.

4.6
In the event that the Institution anticipates the possibility of any
extraordinary expenditures arising from the preparation, filing, prosecution,
licensing, or defense of any patent application or patent contemplated by this
Agreement, including, without limitation, interferences, reexaminations,
reissues and oppositions, the Institution shall provide the NIH with all
relevant information, and these extraordinary expenditures shall be included as
Expenses only upon written agreement of the NIH, provided that if such
extraordinary expenses arc necessary to preserve or to avoid abandonment of the
Patent Rights, the NIH shall not unreasonably withhold its approval of such
extraordinary expenses. The Institution and the NIH shall agree on a mutually
acceptable course of action prior to incurring these expenditures.

5.    LICENSING
5.1
The Institution shall diligently seek licensees for the commercial development
of the Patent Rights and shall administer the Patent Rights for the mutual
benefit of the parties and in the public interest. The Institution shall ensure
that any license granted for the Patent Rights is subject to the provisions of
37 C.F.R. Part 401 and the rights retained by the Government under this
Agreement, including the requirement for substantial manufacture in the United
States as stated in Paragraph 11.1.

5.2
The Institution shall not [***], notwithstanding any other provision of this
Agreement, without the prior written consent of the NIH, provided, however, that
the NIH hereby agrees that HHMI [***].

5.3
The Institution shall consult with the NIH in the [***], notwithstanding any
other provision of this Agreement, and shall not grant these licenses without
the prior review, opportunity for comment, and written approval of the NIH.

5.4
Before licensing of the Patent Rights or any part thereof by the Institution,
the Institution shall first notify and confer with the NIH regarding any
research funding related to the Patent Rights so as to determine the NIH’s
interest in participating in any funded collaborative research project.

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5.5
The Institution shall promptly provide the NIH with complete copies of all
licenses and sublicenses granted for the Patent Rights.

5.6
Institution agrees that its licensees shall supply, to the Mailing Address for
Agreement notices indicated on the Signature Page, the Office of Technology
Transfer, NIH with inert samples of the licensed products or licensed processes,
as covered by the Patent Rights, or their packaging for educational and display
purposes only.

6.    ROYALTIES AND EXPENSES
6.1
[***]

6.2
All payments to the NIH, required under this Agreement, shall be in [***] and
payment options arc listed in Appendix A.

6.3
The Institution shall submit to the NIH annual statements of itemized Expenses
as defined in Paragraph 2.5 and shall deduct the Expenses as provided for in
Paragraph 2.4, except where NIH has identified discrepancies in billing by the
Institution, in which case, deduction of the contested item(s), as a part of the
Expenses as provided for in Paragraph 2.4, from Net Revenues shall be delayed
pending resolution thereof.

6.4
In no event shall the NIH be obligated to bear any costs for Expenses under this
Agreement.

6.5
Each party shall be solely responsible for calculating and distributing to its
respective Inventor(s) of the Patent Rights any share of Net Revenues in
accordance with its respective patent policy, royalty policy, or Federal law
during the term of this Agreement.

7.    RECORDS AND REPORTS
7.1
The Institution shall keep complete, true, and accurate accounts of all Expenses
and of all Net Revenues received by it from each licensee of the Patent Rights
and shall permit the NIH or the NIH’s designated agent to examine its books and
records in order to verify the payments due or owed under this Agreement.

7.2
Upon request by the NIH, the Institution shall submit to the NIH an annual
report, not later than April I of each year, setting forth the status of all
patent prosecution, commercial development, and licensing activity relating to
the Patent Rights for the preceding calendar year.

8.    PATENT INFRINGEMENT
8.1
In the event the NIH or the Institution, including its licensees, shall learn of
the substantial infringement of any patent subject to this Agreement, the party
who

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learns of the infringement shall promptly notify the other party in writing and
shall provide the other party with all available evidence of the infringement.
The Institution and its licensees, in cooperation with the NIH, shall use their
best efforts to eliminate the infringement without litigation. If the efforts of
the parties are not successful in eliminating the infringement within ninety
(90) days after the infringer has been formally notified of the infringement by
the Institution, the Institution shall have the right, after consulting with the
NIH, to commence suit on its own account or permit the Institution’s licensee to
commence suit on the licensee’s own account. The NIH may join the Institution’s
suit or commence its own suit.
8,2
‘If neither the Institution nor its licensee (i) bring suit within one (1) year
after the parties are formally notified of the existence of an infringement, or
(ii) are in negotiations with the infringing party to abate the infringement
within such one (I) year period and either abate the infringement or bring suit
within an additional one (1) year period; then the NIH may bring suit to abate
the infringement at the NIIP sole expense.

8.3
Neither a licensee nor the Institution shall take action to compel the NIH
either to initiate or to join in any suit for patent infringement. Should the
Government be made a party to any suit by motion or any other action of a
licensee or the Institution, the licensee or the Institution shall reimburse the
Government for any costs, expenses, or fees which the Government incurs as a
result of the motion or other action, including any and all costs incurred by
the NIH in opposing any joinder action.

8.4
Legal action or suits to eliminate infringement or recover damages pursuant to
Paragraph 8.1 shall be at the full expense of the party by whom suit is brought.
All damages recovered thereby shall first be used to reimburse each party for
its expenses relating to the legal action, and the remainder of the damages
shall be considered Net Revenues,

8.5
Each party agrees to cooperate with the other in litigation proceedings. The NIH
may be represented, at its expense, by counsel of its choice in any suit.

9.    GOVERNING LAWS, SETTLING DISPUTES
9.1
This Agreement shall be construed in accordance with [***]. Federal law and
regulations shall preempt any conflicting or inconsistent provisions in this
Agreement. The Institution agrees to be subject to the [***].

9.2
Any controversy or any disputed claim by either party against the other arising
under or related to this Agreement shall be submitted jointly to the
Institution’s President or designee and to the Director of the NIH or designee
for resolution. The Institution and the NIH shall be free after written
decisions are issued by

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those officials to pursue all administrative or judicial remedies which may be
available.
10.    TERM AND TERMINATION
10.1
This Agreement is effective when signed by all parties, unless the provisions of
Paragraph 11.10 are not fulfilled, and shall extend to the expiration of the
last to expire of the patents included within the Patent Rights unless otherwise
terminated by operation of law or by acts of the parties in accordance with the
terms of this Agreement.

10.2
The Institution may terminate this Agreement upon at least sixty (60) days
written notice to the NIH, but in any event not less than sixty (60) days prior
to the date on which any pending Patent Office actions need be taken to preserve
patent rights for the benefit of the parties hereto.

10.3
In the event the Institution has made no commitments to any third party for
exclusive license rights relating to the Patent Rights, the NIH may terminate
this Agreement for any reason upon thirty (30) days written notice to the
Institution. During the term of any option agreement or license agreement to any
third party for exclusive license rights relating to the Patent Rights between
the Institution and an optionee or licensee, the NIH may terminate this
Agreement when:

(a)
it is determined by the NIH’s Office of Technology Transfer that:

(i)
The Institution or its licensee has not taken and is not expected to take
effective steps to achieve Practical Application of the Patent Rights;

(ii)
Termination is necessary to alleviate health or safety needs which are not
reasonably satisfied by the Institution or its licensee;

(iii)
Termination is necessary to meet requirements for public use specified by
Federal law or regulations and these requirements are not reasonably satisfied
by the Institution or its licensees; or

(iv)
Termination is necessary because the requirements of 35 U.S.C. §204 have not
been satisfied or waived or because a licensee of the exclusive right to use or
sell the Patent Rights in the United States is in breach of its agreement
obtained pursuant to Section 204;

(b)
the Institution or affected third party has been notified of this determination
and has been given at least thirty (30) days to provide a response to this
determination, and

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(c)
the Institution’s or affected third party’s response to the determination of
10.3(a)(i)-(iv) is determined to be unsatisfactory by the Office of Technology
Transfer.

10.4
The NIH may terminate this Agreement in whole or in part if:

(a)
the Institution fails to make any payment or periodic reports required by this
Agreement;

(b)
the Institution has willfully made a false statement of, or willfully omitted, a
material fact in the negotiation of the Agreement or in any report required by
the Agreement;

(c)
the Institution has committed a substantial breach of a covenant or duty
contained in this Agreement; or

(d)
the NIH and the Institution are involved in a dispute under this Agreement which
cannot be resolved under the procedures specified in Paragraph 9.2 If the
Agreement is terminated under this Paragraph 10.4, the NIH agrees, subject to
the restrictions of 37 C.F.R. Part 404, that any licenses that have been granted
by the Institution shall remain in effect and, Institution obligations to the
NIH including, paying royalties shall survive termination of this Agreement.

10.5
Following termination by the NIH, the NIH shall have no further rights or
obligations under this Agreement, except that the Institution shall be obligated
to administer subsequent gross proceeds from licensing the Patent Rights
according to the Institution policy, and to distribute royalties to the NIH for
the NIH Inventor(s) as though they were Inventor(s) of the Institution under
that policy with respect to royalties and payment schedules.

11.    GENERAL
11.1
[***].

11.2
All Agreement notices required or permitted by this Agreement shall be given by
prepaid, first class, registered or certified mail or by an express/overnight
delivery service provided by a commercial carrier, properly addressed to the
other party at the address designated on the following Signature Page, or to the
other address as may be designated in writing by such other party. Agreement
notices shall be considered timely if the notices are received on or before the
established deadline date or sent on or before the deadline date as verifiable
by U.S. Postal Service postmark or dated receipt from a commercial carrier.
Parties should request a legibly dated U.S. Postal Service postmark or obtain a
dated receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.

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113
This Agreement shall not be construed to confer on any person any immunity from
or defenses under the antitrust laws or from a charge of patent misuse, and the
acquisition and use of rights pursuant to this Agreement shall not be immunized
from the operation of state or Federal law by reason of the source of the grant.

11.4
It is agreed that no waiver by either party hereto of any breach or default of
any of the covenants or agreements herein set forth shall be deemed a waiver as
to any subsequent or similar breach or default.

11.5
This Agreement is binding upon and shall inure to the benefit of the parties
hereto and their successors or assigns, but this Agreement may not be assigned
by either party without the prior written consent of the other party.

11.6
This Agreement confers no license or rights by implication, estoppel, or
otherwise under any patent applications or patents of the NIH other than the
Patent Rights regardless of whether such patents are dominant or subordinate to
the Patent Rights.

11.7
Any modification to this Agreement must be in writing and agreed to by both
parties.

11.8
It is understood and agreed by the Institution and the NIH that this Agreement
constitutes the entire agreement between the parties, and that all prior
agreements respecting the subject matter hereof, either written or oral,
expressed or implied, shall be abrogated, canceled, and are null and void and of
no effect.

11.9
HHMI is not a party to this Agreement and has no liability to any party, but
HHMI is an intended third-party beneficiary of this Agreement and certain of its
provisions are for the benefit of IIHMI and are enforceable by HHMI in its own
name.

11.10 The terms and conditions of this Agreement shall, at the NIH’s sole
option, be considered by the NIH to be withdrawn from Institution’s
consideration and the terms and conditions of this Agreement, and the Agreement
itself to be null and void, unless this Agreement is executed by the Institution
and a fully executed original is received by the NIH within sixty (60) days from
the date of the NIH’s signature found at the Signature Page.
SIGNATURES BEGIN ON NEXT PAGE

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PHS INTERINSTITUTIONAL AGREEMENT-- INSTITUTION
SIGNATURE PAGE
IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate
originals by their respective duly authorized officers, who have affixed their
signatures hereunto, on the day and year hereinafter written. Any communication
or notice to be given shall be forwarded to the respective addresses listed
below.
For NIH:
Richard U. Rodriguez                5/13/13            
Richard U. Rodriguez    Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health

Mailing Address or E-mail Address for Agreement notices and reports:

Chief, Monitoring & Enforcement Branch
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.

E-mail: LicenseNotices_Reports@mailmilLgov

For the Institution:

Upon information and belief, the undersigned expressly certifies or affirms that
the contents of any statements of the Institution made or referred to in this
Agreement are truthful and accurate.
Abram M. Goldfinger                5/13/13            
Signature of Authorized Official    Date

Abram M. Goldfinger
Printed Name

Executive Director Industrial Liaison/Technology Transfer
Title

Official and Mailing Address for Agreement notices:

Abram M. Goldfinger
Name

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Executive Director Industrial Liaison/Technology Transfer
Title

Mailing Address:

New York University
Office of Industrial Liaison
One Park Avenue. 6th Floor,
New York. New York 10016 U.S.A.

Email Address:    abram.goldfinger@nyume.org
Phone:    212-263-8178
Fax:    212-263-8189

And:

Annette Johnson. Esq.
Name

Vice Dean and Senior Counsel for Medical School Affairs
Title

Mailing Address:

550 First Avenue. HCC 15
New York, New York 10016 U.S.A.

Email Address:    annettejohnson@nyumc.org
Phone:    212-263-7921
Fax:    212-263-3235

Official and Mailing Address for Financial notices (Institution’s contact person
for royalty payments)
Abram M. Goldfinger
Name

Executive Director Industrial Liaison/Technology Transfer
Title

Mailing Address:

New York University

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Office of Industrial Liaison
One Park Avenue. 6th Floor,
New York. New York 10016 U.S.A.

Email Address:    abram.goldfinger@nyume.org
Phone:    212-263-8178
Fax:    212-263-8189

Any false or misleading statements made, presented, or submitted to the
Government, including any relevant omissions, under this Agreement and during
the course of negotiation of this Agreement are subject to all applicable civil
and criminal statutes including Federal statutes 31 U.S.C. 03801-3812 (civil
liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or
imprisonment).

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APPENDIX A — ROYALTY PAYMENT OPTIONS
[***]

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APPENDIX B — HHMI LICENSING PROVISIONS
Any licenses granted by the Institution under this Agreement shall include the
following HI•IMI licensing provisions, where University shall mean Institution:
1.    Identification of HHMI Investigators
If inventors are named in the license, HHMI investigators and HHMI
inventor/employees should be properly identified as employees of the Howard
Hughes Medical Institute doing research at the HHMI laboratory at the
University.
Example:
The invention was made by Dr. __________, an employee of the Howard Hughes
Medical Institute and a faculty member at the University.

2.    Scope of Rights
HHMI requires that the scope of rights in future technology granted under a
license not go beyond the following:
“Patent rights” shall mean and include all of the following intellectual
property of the University:
The United States patents and/or patent applications listed in Appendix A [to
the license]; United States patents issued from the applications listed in
Appendix A and from divisionals and continuations of these applications and any
reissues of such United States patents; claims of continuation-in-part
applications and patents directed to subject matter specifically described in
the applications listed in Appendix A; and claims of all foreign patent
applications, patents, and other intellectual property which are directed to
subject matter specifically described in the United States patents and/or patent
applications listed in Appendix A.
3.    HHMI Research Use License
The license must reflect the fact that HHMI retains an institution-wide,
paid-up, non-exclusive irrevocable license to use the intellectual property for
its research purposes (without the right to sublicense or assign) by including
the following:
Licensee acknowledges that it has been informed that the [licensed technology]
was developed, at least in part, by employees of HHMI and that HHMI has a
paid-up, non-exclusive, irrevocable license to use the [licensed technology] for
IIHMI’s research purposes, but with no right to assign or sublicense (the “HHMI
License”). This license is explicitly made subject to the HHMI License.
When exclusive licenses are being negotiated, HHMI’s research tools policies
must be considered. If research tools developed in an HHMI laboratory (including
software) are to be licensed on an exclusive basis, unless otherwise agreed by
HHMI, HHMI requires that the

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University establish a licensing plan acceptable to HHMI showing how the
research tools will be made available to the research community on reasonably
acceptable terms.
4.    Indemnification
HHMI requires that it and its trustees, officers, employees and agents be
indemnified and held harmless by licensees against claims based on or arising
out of the license. The following is the indemnification provision that HHMI
requires in licenses.
Howard Hughes Medical Institute (“HHMI”), and its trustees, officers, employees,
and agents (collectively, “HHMI Indemnitees”), will be indemnified, defended by
counsel acceptable to HHMI, and held harmless by [the licensee, sublicensee, or
other contracting party] from and against any claim, liability, cost, expense,
damage, deficiency, loss, or obligation, of any kind or nature (including,
without limitation, reasonable attorneys’ fees and other costs and expenses of
defense) (collectively, “Claims”), based upon, arising out of, or otherwise
relating to this [license, sublicense, or other contract or agreement],
including without limitation any cause of action relating to product liability.
The previous sentence will not apply to any Claim that is determined with
finality by a court of competent jurisdiction to result solely from the gross
negligence or willful misconduct of an HHMI Indemnitee.
HIIMI’s indemnification must survive termination indefinitely.
HHMI’s required indemnification language does not provide a right to receive
notice of claims or to settle claims. If the licensee requires the right to
settle claims against HHMI and/or to receive notice of claims, then the
following provisions should be added.
An indemnified party shall provide Licensee with prompt notice of any claim for
which indemnification may be sought pursuant to this Agreement. In the case of
any HHMI Indemnitee, notice shall be given reasonably promptly following actual
receipt of written notice thereof by an officer or attorney of HHMI.
Notwithstanding the foregoing, the delay or failure of [any indemnified party]
[ally HHMI Indemnitee] to give reasonably prompt notice to Licensee of any such
claim shall not affect the rights of such [HHMI Indemnitee] [indemnified party)
unless, and then only to the extent that, such delay or failure is prejudicial
to or otherwise adversely affects Licensee.
Licensee agrees not to settle any Claim against an HHMI Indemnitee without
HHMI’s written consent, where (a) such settlement would include any admission of
liability on the part of any HHMI Indemnitee, (b) such settlement would impose
any restriction oil any HHMI indemnitee’s conduct of any of its activities, or
(c) such settlement would not include an unconditional release of all IIHM1
lndemnitees from all liability for claims that are the subject matter of the
settled Claim.
5.    Insurance

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HHMI asks for the same insurance protection as the University receives in any
license. This insurance protection should survive termination.
Licensee shall have the insurance coverage set forth below. Such coverage shall
be purchased from a carrier or carriers having an A. M. Best rating of at least
A- (A minus) and shall name the University and IIHMI as additional insureds.
6.    HHMI Third-Party Beneficiary Status
The license should describe HMI’s status and rights as a third-party beneficiary
as follows:
HHMI is not a party to this Agreement and has no liability to any licensee,
sublicensee, or user of anything covered by this Agreement, but HHMI is an
intended third-party beneficiary of this Agreement and certain of its provisions
are for the benefit of HI1M1 and are enforceable by HHMI in its own name.
7.    Arbitration
HHMI does not permit the provisions in the license governing its rights to be
subject to binding arbitration. Accordingly, if the licensee requires that all
parties submit to binding arbitration, disputes relating to HHMI’s rights must
be carved out of the requirements. The following is model language to exclude
HHMI’s rights from a binding arbitration provision.
Notwithstanding the foregoing, no dispute affecting the rights or property of
HHMI shall be subject to the arbitration provisions set forth above.
8.    Sublicenses
HHMI requires that sublicensees be bound by the obligations in the sections of
the License on indemnification, insurance and HHMI’s third party beneficiary
status, in accordance with the following:
Licensee shall have the right to grant sublicenses consistent with this
Agreement, which sublicenses shall include, without limitation, a provision
binding sublicensees to all terms hereof intended for the protection of the
University and other indemnified parties, including HHMI, against liability or
loss.
9.    Use of Name Provision
The University shall include one of the two following provisions:
LICENSEE acknowledges that under HHMI policy, LICENSEE may not use the name of
HHMI or of any HHMI employee (including Dr. [Investigator Name]) in a manner
that reasonably could constitute an endorsement of a commercial product or
service; but that use for other purposes, even if commercially motivated, is
permitted provided that (1) the use is limited to accurately reporting factual
events or occurrences, and (2) any reference

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to the name of HHMI or any MIMI employees in press releases or similar materials
intended for public release is approved by HHMI in advance.
LICENSEE may use Dr. _____’s name so long as any such usage (i) is limited to
reporting factual events or occurrences only, and (ii) is made in a manner that
could not reasonably constitute an endorsement of LICENSEE or of any LICENSEE
program, product or service. However, LICENSEE shall not use Dr._____’s name or
the Institute’s name in any press release, or quote Dr._____ in any company
materials, or otherwise use Dr. _____’s name or the Institute’s name in a manner
not specifically permitted by the preceding sentence, unless in each case
LICENSEE obtains in advance the written consent of the Institute, and, in the
case of the use of Dr. _____’s name, Dr. _____’s consent as well.

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EXHIBIT B
SELECTED INVENTORY
[***]

Exhibit B-1

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EXHIBIT C
RESPIRATORY INDICATIONS
[***]

Exhibit C-1

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EXHIBIT D
TERMS OF SUBLICENSE AGREEMENT
[***]
All terms required, pursuant to Section 5.06 of the NYU License Agreement, to be
included in a sublicense under the License.
Orca Ltd’s diligence obligations [***] to be determined.
Orca Ltd to pay to Purchaser all amounts due to NYU pursuant to the NYU License
Agreement on account of the grant to Orca Ltd of the sublicense, the grant by
Orca Ltd of sub-sublicenses or the exercise of such sublicenses or
sub-sublicense by Orca Ltd or its sublicensee(s).
In addition to the amounts to be paid by Orca Ltd to Purchaser to satisfy
payment obligations of Purchaser to NYU, Orca Ltd shall pay to Purchaser:
[***]

Exhibit D-1

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

EXHIBIT E
SUBLICENSEE OBLIGATIONS UNDER THE NYU LICENSE AGREEMENT
1.
The NYU License Agreement provides in Section 5.06 that “each sublicense granted
by CORPORATION hereunder shall be subject to and subordinate to the terms and
conditions of this Agreement”. Accordingly:

a.
Orca Ltd shall not knowingly do anything which will place Purchaser in breach of
the NYU License Agreement; and

b.
Orca Ltd shall provide Purchaser with all reasonable assistance requested by
Purchaser (which shall be at Purchaser’s cost unless otherwise agreed or
otherwise provided in this Agreement) in meeting Purchaser’s obligations under
the NYU License Agreement; and

c.
Orca Ltd shall indemnify, defend and hold harmless Purchaser and its employees,
officers and agents against any liability, damage, loss or expense (including
reasonable attorney’s fees and expenses of litigation) incurred by or imposed
upon Purchaser (including under the NYU License Agreement) in connection with
any claim, suit, action, demand or judgment (i) arising out of the design,
production, manufacture or use by Orca Ltd of any Licensed Product pursuant to
the license granted to Orca Ltd in Section 5.6 of this Agreement; or (ii)
arising out of any other activities to be carried out pursuant to such license.

2.
In relation to confidential information:

a.
the terms of the NYU License Agreement, and any confidential information of NYU
provided to Purchaser under the NYU License Agreement, shall as between the
parties be the Confidential Information of Purchaser, and shall be treated by
Orca Ltd accordingly in accordance with Section 5.9 of this Agreement; and the
terms of this Agreement may be disclosed to NYU (and Sellers consent to such
disclosure) in accordance with the NYU License Agreement (and shall be treated
as Purchaser’s confidential information under the terms of the NYU License
Agreement).

3. The NYU License Agreement provides in Section 5.06(5) that “the sublicense
agreement shall include the text of Sections 11 and 12 of this Agreement” and in
Section 5.06(4) that “the sublicense shall include, without limitation, a
provision binding sublicensees to all terms hereof intended for the protection
of NYU and other indemnified parties, including NIH and HHMI, against liability
or loss”. The intention of these sections of the NYU License Agreement is to
ensure that Orca Ltd provides the Indemnified Parties with an indemnity
equivalent to that set out in Section 11 of the NYU License Agreement and to
ensure that Orca Ltd is required to take out adequate insurance in this regard.
Accordingly, the parties agree as follows:

Exhibit E-1

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a.
subject to clause 3(c), Orca Ltd shall indemnify, defend and hold harmless each
of the Indemnitees against any liability, damage, loss or expense (including
reasonable attorney’s fees and expenses of litigation) incurred by or imposed
upon that Indemnitee in connection with any claims, suits, actions, demands,
orjudgements (collectively “Claims”):

i.
arising out of the design, production, manufacture, sale, use in commerce or in
human clinical trials, lease or promotion by Orca Ltd or its agents of any
Licensed Product, process or service related to, or developed pursuant to, the
license granted in Section 5.6; or

ii.
arising out of any other activities of Orca Ltd pursuant to this Agreement,
provided that Orca Ltd shall have no obligation to indemnify, defend or hold
harmless any NYU Indemnified Party against any liability, damage, loss or
expense to the extent it is attributable to the negligent activities of any such
NYU Indemnified Party;

b.
subject to clause 3(c), Orca Ltd shall indemnify, defend (by counsel acceptable
to HHMI) and hold harmless the HHMI Indemnitees from and against any claim,
liability, cost, expense, damage, deficiency, loss or obligation, in each case
of any kind or nature (including, without limitation, reasonable attorneys’ fees
and other costs and expenses of defence) (collectively, “HHMI Claims”) based
upon, arising out of, or otherwise relating to this Agreement or any other
sublicense, including without limitation any cause of action relating to product
liability, excepting any HHMI Claim that is determined with finality by a court
of competent jurisdiction to result solely from the gross negligence or wilful
misconduct of an HHMI Indemnitee;

c.
Orca Ltd shall be relieved of its obligations to indemnify, defend and hold
harmless any Indemnified Party in relation to any Claim or HHMI Claim (as the
case may be) to the extent that the relevant Indemnified Party has delayed in
giving or failed to give prompt notice to Orca Ltd of the relevant Claim or HHMI
Claim in accordance with the provisions of Section 11 of the NYU License
Agreement, and such failure or delay is prejudicial to or otherwise adversely
affects Orca Ltd;

d.
Orca Ltd (or if required by the NYU License Agreement, Purchaser) shall direct
and control the defence of any Claim or HHMI Claim governed by clause 3(a) or
3(b) (as applicable) and shall provide attorneys acceptable to the Indemnified
Party (such acceptance not unreasonably to be withheld) to defend any such Claim
or HHMI Claim. Orca Ltd shall keep the Licensor and relevant Indemnified Parties
informed of progress in the defence and disposition of the relevant Claim or
HHMI Claim. Purchaser shall use reasonable endeavours to procure that the
Indemnified Parties shall cooperate as reasonably requested by Orca Ltd (at Orca
Ltd’s expense) in the defence of any Claim or HHMI Claim and in accordance with
the NYU License Agreement. Orca Ltd shall not settle any

Exhibit E-2

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

Claim or HHMI Claim without the prior written consent of the relevant
Indemnified Party if such settlement would:
i.
include any admission of liability on the part of the relevant Indemnified
Party;

ii.
impose any restriction on the relevant Indemnified Party’s activities; or

iii.
not include an unconditional release of the relevant Indemnified Party from all
liability for claims that are the subject matter of the relevant Claim or HHMI
Claim.

e.
Orca Ltd shall during the term of the license granted in Section 5.6 (and as
applicable after the expiration or termination of such license) maintain
insurance policies, or self-insure, in each case in accordance with the
provisions of Section 12 of the NYU License Agreement as if:

i.
references in that section to “CORPORATION” were references to Orca Ltd; and

ii.
references in that section to “Section 11 of this Agreement” were references to
clauses 3(a) through 3(f) (inclusive) of this Exhibit E. The taking of insurance
in accordance with this clause 3(f) shall not limit Orca Ltd’s liability with
respect to its obligations under this Agreement.

4.
The Indemnified Parties are third party beneficiaries of this Exhibit E and may
enforce the terms of this Exhibit E directly as against Orca Ltd.

5.
Orca Ltd and Purchaser acknowledge that the United States government retains
rights in intellectual property funded under any grant or similar contract with
a Federal agency, and that:

a.
the rights granted to Purchaser under the NYU License Agreement; and

b.
the rights granted to Orca Ltd under Section 5.6 are subject to all applicable
United States government rights and requirements, including, but not limited to,
any applicable requirement that products which result from such intellectual
property and are sold in the United States, must be substantially manufactured
in the United States.

Exhibit E-3

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Exhibit 10.8

AMENDMENT TO THE ASSET PURCHASE AGREEMENT
THIS AMENDMENT TO THE ASSET PURCHASE AGREEMENT is effective as of August 26,
2016 (this “Amendment”) and amends the Asset Purchase Agreement (the “Asset
Purchase Agreement”) dated November 23, 2015 by and between Brickell Biotech,
Inc., a Delaware corporation (“Purchaser”), and Orca Pharmaceuticals LLC, a
Delaware limited liability company (“Orca LLC”) and Orca Pharmaceuticals
Limited, a company incorporated and registered under the laws of England and
Wales (“Orca Ltd”), Orca LLC and Orca Ltd each known individually as a “Seller”
and collectively as “Sellers”. Terms used herein without definition shall have
the meaning given them in the Asset Purchase Agreement.
RECITALS:
A.    Purchaser and Sellers have agreed to allow Sellers a certain Grant of
Rights to Orca, Ltd as outlined in Section 5.6 of the Asset Purchase Agreement.
B.    Purchaser and Sellers now desire to amend the Asset Purchase Agreement to
allow for an additional six months to be added to the Option Period as defined
in Section 5.6(b) of that agreement.
NOW THEREFORE, each of the undersigned, intending to be legally bound hereby,
agrees as follows:
1.
Option Period Extension. In Section 5.6(b) of the Asset Purchase Agreement, the
words “the end of the First Year” shall be removed and replaced by the words
“eighteen (18) months from the Effective Date” so that Section 5.6(b) reads as
follows in its entirety (amendment italicized):

(b)    At Orca Ltd’s written request any time prior to eighteen (18) months from
the Effective Date, or within 30 days after completion of research conducted by
Orca Ltd pursuant to sub-section 5.6(a) above, whichever is earlier (“Option
Period”), the Parties will negotiate in good faith to agree upon the terms and
conditions of, and upon agreement upon such terms and conditions, promptly enter
into an agreement pursuant to which Purchaser will grant to Seller an exclusive,
sub-licensable, sub-license under the Licensed Technology and Research Results,
to research, develop, manufacture, use, sell or otherwise commercialize
Compounds and Products in the Orca Field, which terms and conditions will
include the terms and conditions set forth in Exhibit D and additional, mutually
agreed terms and conditions (“Sublicense Agreement”). If the Purchaser and Orca
Ltd do not enter into the Sublicense Agreement prior to the end of the Option
Period, Purchaser shall not have any obligations to Orca Ltd, and Orca Ltd.
shall not have any rights, with respect to the Licensed Technology, Compounds or
Products in the Orca Field or the Research Results; provided, however, that the
foregoing shall not be interpreted as depriving

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Orca Ltd to any rights it may have to the NYU Know-How as a result of a
sublicense from Orca LLC under the Other NYU License.
2.
Entire Amendment. This Amendment sets forth the entire understanding among the
parties with respect to the subject matter hereof. Except to the extent the
Agreement is specifically amended hereby, the provisions of the Agreement,
remain unmodified and in full force and effect and nothing in this Amendment
shall be deemed a waiver of any provision of the Agreement (or any right arising
thereunder) by the parties.

3.
Governing Law. THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED AND ENFORCED
IN ACCORDANCE WITH, THE LAWS OF THE STATE OF DELAWARE OTHER THAN CONFLICT OF
LAWS PRINCIPLES THEREOF DIRECTING THE APPLICATION OF ANY LAW OTHER THAN THAT OF
DELAWARE. The courts of the State of Delaware shall have jurisdiction with
respect to any dispute between the Parties arising under or in connection with
this Amendment, and the Parties submit to the jurisdiction of those courts.

4.
Counterparts. This Agreement may be executed and delivered (including by
electronic or facsimile transmission) in two or more counterparts, and by the
different parties hereto in separate counterparts, each of which when executed
and delivered shall be deemed to be an original but all of which taken together
shall constitute one and the same agreement.

Signature page to follow.

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IN WITNESS WHEREOF, intending to be legally bound hereby, the Parties have
caused this Amendment to be signed in their respective names by their duly
authorized representatives as of the date first above written.
BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer    
Name: Andrew Sklawer    
Title: COO    

ORCA PHARMACEUTICALS LLC

By:/s/ Baiju R. Shah
Name: Baiju R. Shah
Title: Manager

ORCA PHARMACEUTICALS LIMITED

By:/s/ Michael G. Hunter
Name: Michael G. Hunter
Title: Authorized Signatory

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