EXHIBIT 10.28

 

 

 

LICENSE AND ASSIGNMENT AGREEMENT

 

 

 

 

dated

 

 

16 JANUARY 2018

 

 

by

 

 

AETERNA ZENTARIS GMBH

the Licensor

 

and

 

The

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Table of contents

 

1.

Definitions and interpretation

1

2.

Grant of rights / license

13

3.

Governance

15

4.

Technology transfer and technical / regulatory assistance

18

5.

Development

19

6.

Supply

22

7.

Commercialization.

25

8.

Financial Provisions

29

9.

Trademarks

32

10.

Intellectual Property (except Trademarks)

33

11.

Confidentiality

36

12.

Representations, warranties and covenants

38

13.

Indemnity and insurance cover

42

14.

Duration and termination of the agreement

45

15.

Assignment/succession

49

16.

Governing law and disputes

50

17.

Miscellaneous

51

 

Schedule 1

CMO Contracts

 

Schedule 2

Technology Transfer Critical Materials and Timing

 

Schedule 3

FDA Letters

 

Schedule 4

Licensor Materials to be Transferred to Licensee

 

Schedule 5

Disclosure Schedule

 

Schedule 6

Domain Names

 

Schedule 7

Licensor Patent Rights

 

Schedule 8

Supply Chain

 

Schedule 9

Development Plan

 

Schedule 10

PIP Budget

 

 

 

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License and Assignment Agreement

This Agreement is dated 16 January 2018 (“Effective Date”)

Between

, (the “"),; and

Strongbridge Ireland Limited, a corporation incorporated under the laws of
Ireland, (the “"),.

The Licensor and the Licensee sometimes being referred to in this Agreement as a
“Party” or together the “Parties”.

Recitals

A.         The Licensor owns or has the exclusive right to certain technology,
intellectual property rights, regulatory files and confidential and/or
proprietary information relating to the Product (as defined below).

B.          The Licensor is interested in assigning the ownership of the Product
Registrations (as defined below) and granting an exclusive license under the
intellectual property to the Licensee to carry out development, manufacturing,
registration and commercialization of the Product in the Territory (as defined
below).

C.          The Licensee, together with its Affiliates (as defined below), are
engaged in the development, manufacturing and commercialization of
pharmaceutical products in the Territory and possess the resources, skills and
experience there necessary to perform their obligations under this Agreement.

The Parties now agree as follows:

1.          Definitions and interpretation

“Adult Indication” means assessing GHD in adults.

“Affiliates” means an entity that has a relationship directly or indirectly with
another entity such that either entity is Controlled by, Controlling, has the
power to Control, or under common Control with the other entity, or a third
party Controls, or has the power to Control, both of the entities, where
“Control” means possession, directly or indirectly, of the power to direct or
cause the direction of the activities, management and policies of the relevant
entity and in the case of a corporate entity shall include but not be limited to
the holding of more than fifty percent (50%) of the share capital of the entity
or the equivalent power or authority to elect more than fifty percent (50%) of
the board of directors of such entity or the equivalent management body. The
Parties acknowledge that in the case of certain entities organized under the
Laws of certain countries outside of the EU, the maximum percentage ownership
permitted by Law for a foreign investor may be less than fifty percent (50%),
and that in such case such lower percentage shall be substituted in the
preceding sentence, provided that such foreign investor has the power to direct
the management and policies of such entity.

“Agreement” means this License and Assignment Agreement together with its
attached Schedules.

“Anti-Bribery Law” means the US Foreign Corrupt Practices Act, UK Bribery Act
2010 and any other applicable Law, rule, regulation, or other legally binding
measure of any jurisdiction that relates to bribery, corruption, or, for
purposes of U.S. Law, transfers of value to licensed healthcare providers.

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“API” means the active pharmaceutical ingredient macimorelin acetate, and any
metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form,
free base form, crystalline form, co-crystalline form, amorphous form, pro-drug,
racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form
of any of the foregoing.

“Bankruptcy Event” means, with respect to either Party:

(a)         a notice having been issued to convene any meeting for the purpose
of passing a resolution or seeking a petition to wind up or liquidate that
Party, or to seek bankruptcy or official administration, or such a resolution
having been passed or such a petition having been issued, including a petition
under title 11 of the United States Code or any similar statute, Law or
regulation (except in relation to a solvent reconstruction or reorganization of
that Party);

(b)         an involuntary petition in an insolvency proceeding or any
proceeding seeking reorganization, arrangement composition, readjustment,
liquidation or similar relief under any statute, Law or regulation, is filed
against a Party and is not dismissed or stayed within ninety (90) days of the
filing thereof or that Party admits or accepts;

(c)         a trustee in bankruptcy, receiver, administrative receiver, receiver
and manager, court appointed receiver, interim receiver, custodian, sequestrator
or similar officer is appointed in respect of that Party or over any part of
that Party's assets or any third party takes steps to appoint such an officer in
respect of that Party and is not dismissed, vacated or stayed within ninety (90)
days of the appointment thereof and if stayed, is not dismissed or vacated
within ninety (90) days of the such stay;

(d)         a Party takes any step, (including starting negotiations), with a
view to readjustment, rescheduling or deferral of any part of that Party's
indebtedness including a moratorium with creditors, or proposes or makes any
general assignment, composition or arrangement with or for the benefit of all or
some of that Party's creditors or makes or suspends or threatens to suspend
making payments to all or some of that Party's creditors or the Party submits to
any type of voluntary arrangement with creditors; or

(e)         a Party takes any step, (including starting negotiations), to file a
petition or answer seeking for that Party any reorganization, arrangement,
composition, conservatorship, winding up, readjustment, liquidation or similar
relief under any statute, Law or regulation.

“Business Day” means between 9.00 am and 5.00 pm local time on a day other than
a Saturday, Sunday, bank or other public holiday in Germany or any State in the
USA.

“Calendar Quarter” means each period of three months ending on 31 March, 30
June, 30 September or 31 December.

“Calendar Year” means each successive period of twelve calendar (12) months
commencing on 1 January.

“Children” means persons 18 years of age or younger including neonates, infants
and adolescents.

“Clinical Trial” means the administration of the Product to humans for purposes
of generating data on characteristics of the Product including, without
limitation, any study carried out in order to obtain or maintain a Regulatory
Approval in any country of the Territory.

“CMO” means a Person that conducts contract manufacture on behalf of another
Person.

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“CMO Contracts” means those contracts set out at Schedule 1.

“Commercial Information” means all information which is Controlled and relates
to the pricing, reimbursement, marketing, promotion and selling of the Product
including but not limited to (i) commercialization plans, strategic and
implementation; and (ii) pharmaco-economic studies justifying pricing; and (iii)
analysis of competitive products and environment including market research
reports; and (iv) product positioning strategies (including unique selling
proposition and understanding of competitors' positioning strategies) and
promotional strategies (including Promotional Materials); and (v) Pricing
Approval submissions and the content of bids for tenders; and (vi) virtual
product and clinical support approaches and techniques via web page; and (vii)
medical education strategies; and (viii) strategies used for building
relationships with health insurance and managed care entities; and (ix) analysis
of market sales and prescription data; (x) terms of contractual arrangements
with purchasers; and (xi) customer lists.

“Commercialize” or “Commercialization” means any and all activities directed to
commercialization, including marketing, promoting, detailing, importing,
distributing, warehousing, offering for sale, having sold and/or selling a
pharmaceutical product, including market research, pre-launch marketing and
educational activities, and sampling.

“Commercially Reasonable Efforts” means, in respect of a Party, efforts and
resources commonly used by a pharmaceutical company of a similar size to that
Party, based on market capitalization, to Commercialize (or where the phrase
'Commercially Reasonable Efforts' is used in this Agreement in a context other
than relating to Commercialization, to perform such other act as the operative
language of this Agreement states) a product owned by such a company or to which
it has rights, which product is at a similar stage in its development or product
life and is of similar market potential to the Product, in each case taking into
account issues of safety and efficacy, product profile, the proprietary
position, the then-current competitive environment for such product and the
likely timing of such product’s entry into the market, the regulatory
environment and status of such product, and other relevant scientific, technical
and commercial factors, in each case as measured by the facts and circumstances
at the time such efforts are due and in relation to the country or countries to
which such efforts pertain.

“Confidential Information” means, subject to the relevant carve-outs set forth
in Section 11:

(a)         the terms and conditions of this Agreement, for which each Party
will be considered a Disclosing Party and a Recipient Party;

(b)         the Dossier, Know How and Commercial Information within the Licensor
IPR Package for which the Licensor will be considered the Disclosing Party and
the Licensee shall be the Recipient Party;

(c)         information within the Licensee IPR Package in relation to which the
Licensee will be considered the Disclosing Party and the Licensor the Recipient
Party; and

(d)         any other non-public information, whether or not patentable,
disclosed or provided by one Party to the other Party in connection with this
Agreement, including, without limitation, information regarding such Party's
strategy, business plans, objectives, research, technology, products, business
affairs or finances including any non-public data relating to Commercialization
of any product and other information of the type that is customarily considered
to be confidential information by parties engaged in activities that are
substantially similar to the activities being engaged in by the Parties under
this Agreement, for which the Party making such disclosure will be considered
the Disclosing Party and the receiver will be the Recipient Party.

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“Control” (including variations such as “Controlled” and except as used in the
definition of 'Affiliates') means with respect to any intellectual property or
other rights, possession of the right, whether directly or indirectly, and
whether by ownership, license or otherwise, to assign, or grant a license,
sub-license or other right to or under, such intellectual property or other
rights without violating the terms of any agreement or other arrangement with
any Third Party.

“Cost of Manufacture” means the amounts paid or payable by the relevant Party to
the CMO in respect of relevant Products or Materials supplied.

“CTD Format” means the format of a common technical document recommended by ICH
or adopted by any Governmental Authority in the Territory responsible for
marketing authorization or monitoring the marketing of the Product that are
formatting requirements or methods for the submission of other or supplemental
information or data to such Government Authority and as may be updated from time
to time.

“CTM” shall mean Product in a form suitable for administration to humans in a
Clinical Trial manufactured in accordance with the specifications and GMP and as
required by any IND appropriately packaged and labelled.

“Data Room” means the data room hosted and operated by Merrill for and on behalf
of the Licensor, entitled 'Macrilen';

“Development (and the corresponding verb “to Develop”) means all development and
regulatory activities regarding the Product and the API in the Territory,
including:

(a)         carrying out the PIP or any other pediatric study required to obtain
Regulatory Approval for the Product for the Pediatric Indication in any country
in the Territory; and

(b)         preparing, submitting, reviewing or developing data or information
necessary for the purpose of submission to a Regulatory Authority to obtain or
maintain and/or expand Regulatory Approval of the Product in the Territory
including data management, statistical designs and studies, document
preparation, and other related administrative costs.

“Development Costs” means the direct and indirect costs of the PIP currently
anticipated to be five million to six million dollars ($5,000,000 –$6,000,000)
as set forth in the PIP Budget, subject to any increases of such budget agreed
by the Parties.

“Development Plan” means the plan for carrying out the PIP attached in Schedule
9, as such plan may be updated in accordance with Section  5,  either in
relation to the PIP or otherwise.

“Disclosing Party” means the Party which discloses Confidential Information to
the other Party.

“Disclosure Schedule” means the disclosure schedule, in the form of Schedule 5.

“Documents” means analyses, books, CD-ROM, charts, comments, computations,
designs, discs, diskettes, files, graphs, ledgers, notebooks, paper,
photographs, plans, records, recordings, reports, research notes, tapes, web
pages and websites, and any other graphic or written data or other media on
which Know How is made available, communicated, or use whether permanently
stored or available temporarily through other means, and advertising and
Promotional Materials of any nature whatsoever including preparatory materials
for the same.

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“Dossier” means the information and data for the Product in a country in CTD
Format (or otherwise) and as registered with a Regulatory Authority for the
Regulatory Approval containing the administrative, safety, efficacy, quality,
non-clinical and clinical data, chemistry and manufacturing control data and
communications with the Regulatory Authority for the Product as it may change
from time to time.

“EMA” means the European Medicines Agency.

“Encumbrance” means a mortgage, charge, pledge, lien, option, restriction, right
of first refusal, right of pre-emption, third party right or interest, other
encumbrance or security interest of any kind, or another type of preferential
arrangement (including, without limitation, a title transfer or retention
arrangement) having similar effect but for the purposes of this Agreement always
excluding a license.

“EU” means the countries of the European Union from time to time which are
currently Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden and includes the United Kingdom regardless of future treaty or
common relationships with the other countries in the EU or Europe.

“Europe” means that group of countries comprised of the EU plus (if they are not
Member States) Iceland, Liechtenstein, Norway, Switzerland and UK.

“Existing CMO Contracts” has the meaning given to it in Section 6.1.

“Existing Indications” means the Adult Indication and the Pediatric Indication.

“Exploitation Agreement” means the exploitation agreement between (i) Aeterna
Zentaris GmbH (formerly Zentaris GmbH); (ii) The Centre National De La Recherche
Scientifique; (iii) The University of Montpellier 1; and (iv) The University of
Montpellier 2, entered into in 2005.

“FDA” means the U.S. Food and Drug Administration.

“Final Report” means the clinical study report including attachments, quality
assurance, monitoring reports, and raw data that record the performance or
information generated from a Clinical Trial, whether or not compliant with ICH
E3 or conducted under GCP, and that includes such personal health information or
personal identifying information as may be necessary to assure the quality and
integrity of the report.

“First Commercial Sale Date” means the date of the first commercial sale in an
arm's length transaction to a Third Party of the Product for an Existing
Indication in each country in the Territory by or on behalf of the Licensee, an
Affiliate, Sub-licensee after obtaining Regulatory Approval and any Pricing
Approvals for the Product necessary or desirable in such country. For clarity
“First Commercial Sale Date” shall not be any date on which sale of Product for
an Existing Indication occurs in the Territory for use on a compassionate use or
named patient basis.

“Formal Presentation” means a presentation of the results of a Clinical Trial
based on the data and conclusions set out in an Interim Report.

“GCP” means the then-current standards, practices and procedures for good
clinical practices, including but not limited to those promulgated or endorsed
by:

(c)         the European Commission Directive 20/2001/EC relating to good
clinical practice in clinical trials on medicinal products for human use;

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(d)         the ICH Harmonised Tripartite Guidelines for Good Clinical Practice
(E6) and any other guidelines for good clinical practices for trials on
medicinal products in the European Union;

(e)         the FDA as set forth in the guidelines entitled "Guidance for
Industry E6 Good Clinical Practice: Consolidated Guidance," including related
regulatory requirements imposed by the FDA and the provisions of 21 C.F.R. Part
312; and

(f)         the equivalent applicable Law in any relevant country.

“GHD” means growth hormone deficiency.

“GLP” means the then-current standards, practices and procedures for good
laboratory practices, including but not limited to those promulgated or endorsed
by:

(g)         the European Commission Directives 2004/9/EC and 2004/10/EC relating
to the application of the principles of good laboratory practices as well as
"The rules governing medicinal products in the European Union," Volume 3,
Scientific guidelines for medicinal products for human use (ex - OECD principles
of GLP);

(h)         the then-current standards, practices and procedures promulgated or
endorsed by the FDA as defined in 21 C.F.R. Part 58; and

(i)          the equivalent applicable Law in any relevant country.

“GMP”  means the then-current standards, practices and procedures for good
laboratory practices, including but not limited to those promulgated or endorsed
by:

(j)          the European Commission Directives 2004/9/EC and 2004/10/EC
relating to the application of the principles of good laboratory practices as
well as "The rules governing medicinal products in the European Union," Volume
3, Scientific guidelines for medicinal products for human use (ex - OECD
principles of GLP);

(k)         the then-current standards, practices and procedures promulgated or
endorsed by the FDA as defined in 21 C.F.R. Part 58; and

(l)          the equivalent applicable Law in any relevant country;

“Government Authority” shall have the same meaning as Regulatory Authority.

“ICH” means the International Council on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use.

“IND” means an Investigational New Drug Application exemption or Clinical Trial
Application filed with, acknowledged, or accepted by, Governmental Authorities
prior to beginning clinical trials in humans in any country, or any comparable
application to and acceptance by the Regulatory Authority of a country or group
of countries prior to beginning clinical trials in humans in that country or in
that group of countries.

“Interim Report” shall mean a written report that contains an initial analysis
of the results of a Clinical Trial once that Clinical Trial has completed and
the data from that Clinical Trial has been collated and analyzed and, in
particular reporting, on the extent to which the endpoints of the Clinical Study
have been met but which is not the Final Report, has not yet been subject to
quality assurance and precedes the Final Report.

“JSC” means the joint steering committee established under Section 3.1.

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“Know How” means technical and other information which is not in the public
domain, including information and data comprising or relating to (i)
non-clinical data including pharmacological, toxicological and metabolic data
and results of all non-clinical studies relevant to the product; and (ii)
clinical safety and efficacy data including data analyses, study reports and
information contained in protocols, filings or other submissions to and
responses from ethical committees and Regulatory Authorities; and (iii) safety
(pharmacovigilance) data; and (iv) production facilities and processes including
any drug master file, specifications, techniques, manufacturing line procedures,
chemistry and manufacturing control data, standard operating procedures quality
assurance and quality control processes and techniques, and all other
documentation retained to comply with GMP procedures; and (v) information
relating to contract manufacturers and the manufacturing supply chain of the
Product, including API, fill finish, primary and secondary packaging (items (iv)
and (v) together being “Manufacturing Know How”). Know How includes (a)
Documents containing Know How; and (b) includes and covers any legal rights
including trade secrets, copyright, database or design rights protecting such
Know How. The fact that an item is known to the public shall not be taken to
preclude the possibility that a compilation including the item, and/or a
development relating to the item, is not known to the public.

“Knowledge” means a Party's and its Affiliates' understanding in good faith as
possessed in the case of Licensor, by Michael Ward, Gilbert Mueller, Brian
Garrison, Richard Sachse or Matthias Gerlach and in the case of Licensee, by
Stephen Long, Matthew Pauls and A. Brian Davis, of the relevant facts and
information after performing a reasonable investigation with respect to such
facts and information.

“Launch” means the initial transfer of the Product billed or invoiced by
Licensee (or an Affiliate or Sub-licensees) to a non-Sub-licensee Third Party in
the Territory following the Effective Date.

“Law” or “Laws” means any federal, state, local, municipal, foreign,
international, multinational, or other constitution, law, statute, treaty, rule,
regulation, ordinance, code, binding case law or principle of common law, rule
or regulation, promulgated or issued by an Governmental Authority, as well as
any Judgments, decrees, injunctions or agreements of any entity in the course of
dispute resolution that might have binding or precedential effect on the
Parties, and also includes any industry standard, third party certification, any
technical or scientific standard to which adherence is required by any
Governmental Authority and any rules or policies of non-governmental
accreditation, standards, certification, or oversight bodies and includes any
obligations or responsibilities applicable to holders of Product Registrations
including, without limitation, pharmacovigilance and required annual or
expedited reporting needed to maintain such Product Registration.

“Legal Requirement” means any applicable Law of any Government Authority
including any amendment, extension or replacement thereof which is from time to
time in force.

“License” means the rights and license granted by Licensor to Licensee pursuant
to the terms of Section 2.1.

“Licensee CMO Contracts” has the meaning given to it in Section 6.2.

“Licensee IPR Package” means the intellectual property and other rights at any
time during the Term Controlled by the Licensee or its Affiliates relating to
the Product pursuant to Section 10.3 including but not limited to:

(a)         Licensee Patent Rights;

(b)         Know How;

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(c)         Dossiers;

(d)         Commercial Information; and

(e)         the Licensee Trademark.

“Licensee Know-How” means the Know-How Controlled by the Licensee at the date of
termination of this Agreement solely to the extent related to the Product.

“Licensee Materials” means the Materials Controlled by the Licensee at the date
of termination of this Agreement that are necessary to Manufacture the Product.

“Licensee Patent Rights” means all Patent Rights generated or developed by or on
behalf of the Licensee and/or its Affiliates at any time during the Term of this
Agreement containing claims covering the Product or the Manufacturing of the
Product.

“Licensee Trademarks” means all Trademarks Controlled by the Licensee relating
solely to the Product, but excludes the Licensor Trademark.

“Licensor IPR Package” means the intellectual property and other rights
Controlled by the Licensor or its Affiliates relating to the Product (with the
exception of the Licensor Materials, Controlled at any time during the Term)
including but not limited to:

(a)         the Licensor Patent Rights;

(b)         Know How;

(c)         Dossiers;

(d)         the Commercial Information in relation to the Territory; and

(e)         the Licensor Trademark.

“Licensor Materials” means those Materials of the Licensor as set out in
Schedule 4.

“Licensor Patent Rights” means the Patent Rights Controlled by the Licensor at
any time during the Term of this Agreement in the countries of the Territory
containing claims covering the Product and approved uses of the Product, which
at the Effective Date are those set out in Schedule 7.

“Licensor Supply Period” has the meaning given to it in Section 6.4.

“Licensor Trademark” means the Macrilen trademark registered in the Territory
and any accompanying logos, trade names, trade dress and/or other indicia
relating to the Product Controlled by the Licensor.

“Losses” means any and all losses, damages, liabilities, costs and expenses
(including, without limitation, reasonable attorneys' fees and expenses). In
calculating “Losses”, the duty to mitigate on the part of the Party suffering
the Losses shall be taken into account.

“Manufacture” or “Manufacturing” means to make, have made, produce, manufacture,
process, fill, finish, package, label, perform quality control testing, perform
quality assurance, release procedures, ship or store a compound or product or
any component thereof. When used as a noun, “Manufacture” or “Manufacturing”
means any and all activities involved in Manufacturing a compound or product or
any component thereof.

“Material” means any quantities of raw materials (including, without limitation,
active pharmaceutical ingredients, drug substance, precursors, intermediates,
drug product and

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excipients), labels, packaging materials, dedicated physical components, and
dedicated equipment, reference standards or reagents, needed for the
Manufacturing of the Product.

“NDA” means the new drug application filed with and approved by the FDA for the
Product having NDA number 205598.

“NDA Product” means the Product that is the subject of the NDA.

“Net Sales” means:

(m)        the gross amount invoiced by the Licensee, its Affiliates,
Sub-licensees or Sub-distributors for sale of Products to third parties, less
the following deductions relating to sales of the Products in each case as
required by applicable GAAP:

(i)          normal and customary trade, cash and quantity discounts accrued or
actually given, credits, price adjustments or allowances for damaged products,
returns or rejections of products;

(ii)        chargeback payments and rebates (or the equivalent thereof) for the
Product granted to group purchasing organizations, managed health care
organizations or to federal, state/provincial, local and other governments,
including their agencies, or to trade customers;

(iii)       reasonable and customary freight, shipping insurance and other
transportation expenses directly related to the sale of the Product (if actually
borne by the Licensee, its Affiliates, or Sub-licensees without reimbursement
from any Third Party);

(iv)        required distribution commissions/fees payable to any Third Party
providing distribution services to the Licensee; and

(n)         sales, value-added, excise taxes, tariffs and duties, and other
taxes and government charges directly related to the sale, to the extent that
such items are included in the gross invoice price of the Product and actually
borne by the Licensee, its Affiliates, or Sub-licensees without reimbursement
from any Third Party (but not including taxes assessed against the income
derived from such sale).

For these purposes sale of Products shall include the Product as Developed by
the Licensee from time to time.

Nothing herein shall prevent Licensee or any of its Affiliates or Sub-licensees
from making selling, distributing or invoicing Product at a discounted price for
shipments to Third Parties in connection with clinical studies, sampling,
compassionate sales, or an indigent program or similar bona fide arrangements in
which such party agrees to forego a normal profit margin for good faith business
reasons and notwithstanding anything herein to the contrary, to the extent such
distribution is made without charge it shall not be deemed a sale for purposes
of determining Net Sales. Sales or other commercial dispositions of Products (1)
between Licensee and its Affiliates and/or its Sub-licensees (except where such
Affiliates or Sub-licensees are an end user of the Product), or (2) provided to
Third Parties without charge, in connection with research and development,
Clinical Trials, compassionate use, humanitarian and charitable donations, or
indigent programs or for use, in reasonable and customary quantities, as
samples, shall in each case, be excluded from the computation of Net Sales, and
no payments will be payable on such sales or such other commercial dispositions.

“New Indication” means an indication for the treatment of any disease or
condition other than the Existing Indications.

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“Outstanding CMO Contracts” has the meaning given to it in Section 6.1.

“Pediatric Indication” means assessing GHD in Children.

“Patent Rights” means:

(a)         all national, regional and international patents and patent
applications, including provisional patent applications; and

(b)         all patent applications filed either from such patents, patent
applications or provisional applications or from an application claiming
priority from any of these, including divisionals, continuations,
continuations-in-part, provisionals, converted provisionals, and continued
prosecution applications; and

(c)         any and all patents that have issued or in the future issue from the
foregoing patent applications in paragraphs (a) and (b) above, including author
certificates, inventor certificates, utility models, petty patents and design
patents and certificates of invention; and

(d)         any and all extensions or restorations by existing or future
extension or restoration mechanisms, including revalidations, reissues,
re-examinations and extensions (including any supplementary protection
certificates and the like) of the foregoing patents or patent applications in
paragraphs (a) to (c) above inclusive, and

(e)         any similar rights, including so-called pipeline protection (where
the subject matter previously disclosed was not previously patentable in a
particular jurisdiction but subsequently becomes patentable subject matter in
such jurisdiction), or any importation, revalidation, confirmation or
introduction patent or registration patent or patent of additions to any such
foregoing patent applications and patents.

“Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, incorporated association,
joint venture or similar entity or organization, including a government or
political subdivision, department or agency of a government.

"PIP" means the pediatric investigation plan, pediatric study plan, the
pediatric study, pediatric drug development and/or any other clinical or
pharmacological data collection as submitted to and agreed by EMA (April 11
2017) and which will support authorization of PGHD for the Product by EMA and as
further requested by FDA in FDA’s Pediatric Written Request (PWR) under the Best
Pharmaceuticals for Children Act (BPCA) which PWR stipulates that the PIP as
submitted and agreed to by EMA will meet the requirements to obtain a period of
pediatric exclusivity in the U.S..

“PIP Budget” means the budget attached hereto as Schedule 10, which budget
relates to the PIP and sets out the direct and indirect costs of the PIP
anticipated by the Parties as at the Effective Date as such budget may be
updated from time to time in accordance with Section 5.5.

“Pricing Approval” means:

(a)         such approval, agreement, determination or governmental decision
establishing prices for the Product that can be charged and will be reimbursed
by Government Authorities in countries in the Territory where Government
Authorities or Government Authorities of such country approve or determine
pricing for pharmaceutical products for reimbursement or otherwise; and

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(b)         a price established in a supply contract with a Government Authority
following a tender process.

“Product” means any pharmaceutical product containing the API, including the
product developed by the Licensor for the Existing Indications and approved by
the FDA for marketing in the United States under the NDA.

“Product Registrations” means all applications (including any IND, and the NDA),
orphan designations, new drug applications, abbreviated new drug applications,
new drug submissions, and any comparable applications and submissions, together
with any and all supplements or modifications or amendments thereto, whether
existing, pending, withdrawn or in draft form, together with all correspondence
to or from any Governmental or Regulatory Authority with respect thereto,
prepared and submitted to any Governmental or Regulatory Authority in the
Territory with respect to the Product including the NDA and any supplemental
drug applications filed with and approved by the FDA or other Regulatory
Authorities for the Product whether relating to the Pediatric Indication, a New
Indication and/or other dosages of the Product.

“Promotional Materials” means all sales representative training materials and
all written, printed, graphic, electronic, audio or video matter, including
journal advertisements, sales visual aids, leave-behind items, reprints, direct
mail, internet postings and sites and broadcast advertisements intended for use
or used by or on behalf of Licensee or its Affiliates in connection with any
promotion of a Product.

“Recipient Party” means the Party which receives Confidential Information from
the other Party.

“Regulatory Approval” means any approval required from a Regulatory Authority to
market and sell a pharmaceutical product in any country of the Territory
including the NDA, but excluding any Pricing Approval required or commercially
desirable.

“Regulatory Authority” means any supranational, national or local parliament,
regional, state, county, city, town, village, municipal, district, commission,
department or agency including FDA, EMA, or any competent authority in the EU,
Europe or the United Kingdom or other country in which the Product holds
marketing authorization, authority (including a listing authority in relation to
a stock exchange), inspectorate, minister, ministry official, or other public or
statutory Person (whether autonomous or not), multinational organization or any
other body exercising, or entitled to exercise, any administrative, executive,
judicial, legislative, police, regulatory or taxing authority or power of any
nature over the Parties.

“Regulatory Submissions” means any submission by a Person to a Regulatory
Authority in connection with the Product.

“Royalty Term” means, Existing Indication by Existing Indication, and country by
country of the Territory, the period that is from the First Commercial Sale Date
until the later of either:

(a)         the expiry of all Valid Claims of the Licensor Patent Rights in such
country;

(b)         the expiration of any regulatory marketing exclusivity period or
other statutory designation that provides similar exclusivity for the
Commercialization of the Product in such country; and

(c)         ten (10) full Calendar Years following such First Commercial Sale
Date.

Where “expiry” in relation to a Valid Claim for purposes of royalty calculations
means the cessation of a claim to meet the definition of Valid Claim.

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“Sub-licensee” means a Third Party to whom the Licensee or its Affiliates grants
a sublicense in accordance with Section 2.

“Supply Chain” has the meaning given to it in Section 6.1.

“Taxes” means all taxes of any kind, and all charges, fees, customs, levies,
duties, imposts, required deposits or other assessments, including all federal,
state, local or foreign net income, capital gains, gross income, gross receipt,
property, franchise, sales, use, excise, withholding, payroll, employment,
social security, workers' compensation, unemployment, occupation, capital stock,
ad valorem, value added, transfer, gains, windfall profits, net worth, asset,
transaction, and other taxes, and any interest, penalties or additions to tax
with respect thereto, imposed upon any individual or entity by any taxing
authority or other governmental authority under the Laws of the applicable
country in the Territory.

“Term” means the period commencing on the Effective Date and, unless earlier
terminated in accordance with this Agreement, expiring country by country of the
Territory at the end of the Royalty Term in such country.

“Term Loan Agreement” means the Term Loan Agreement, dated as of July 14, 2017,
among Strongbridge U.S. Inc., a Delaware corporation, Strongbridge Biopharma
Public Limited Company, a public limited company incorporated under the laws of
Ireland, the Licensee, Cortendo Cayman Ltd., an exempted company incorporated in
the Cayman Islands, Cortendo AB (Publ), a public limited liability company
incorporated under the laws of Sweden, the subsidiary guarantors from time to
time party thereto, the lenders from time to time party thereto and CRG
Servicing LLC, a Delaware limited liability company, as amended, supplemented or
otherwise modified from time to time.

“Territory” means the United States of America and Canada.

“Third Party” means a party other than either of the Parties or any of their
respective Affiliates.

“Trademarks” means registered trademarks and applications thereof, unregistered
trade or service marks, get up, logos, trade dress and company names in each
case with any and all associated goodwill and all rights or forms of protection
of a similar or analogous nature including rights which protect goodwill.

“Valid Claim” means either:

(a)         a claim of an issued and unexpired patent included within Patent
Rights, which has not been held revoked, unenforceable or invalid by a decision
of a court or other governmental agency of competent jurisdiction, unappealable
or un-appealed within the time allowed for appeal, and which has not been
admitted to be invalid or unenforceable through reissue or disclaimer or
otherwise; or

(b)         a claim of a pending patent application included within Patent
Rights which claim was filed and is being prosecuted in good faith and has not
been abandoned or finally disallowed without the possibility of appeal or
refiling of the application, provided that no more than seven (7) years have
passed since the earliest priority date for such application.

“Year” means each complete Calendar Year following the First Commercial Sale
Date.

1.2        In this Agreement:

(a)         the table of contents and headings are inserted for ease of
reference only and shall not affect the interpretation of any provision of this
Agreement;

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(b)         all references to a particular Section, paragraph or Schedule shall
be a reference to that Section, paragraph or Schedule, in or to this Agreement
as it may be amended from time to time pursuant to this Agreement;

(c)         words in one gender include any other gender, words importing
individuals import companies and vice versa, words in the singular include the
plural and vice versa, and words importing the whole shall be treated as
including a reference to any part thereof;

(d)         references to a company shall include any company, corporation or
other body corporate wherever and however incorporated or established;

(e)         reference to the words “include” or “including” (or any similar
term) are not to be construed as implying any limitation and general words
introduced by the word “other” (or any similar term) shall not be given a
restrictive meaning by reason of the fact that they are preceded by words
indicating a particular class of acts, matters or things;

(f)         references to “writing” or “written” includes any method of
reproducing words or text in a legible and non-transitory form and, for the
avoidance of doubt, shall include text transmitted by e-mail;

(g)         references to “indemnify” and to “indemnifying” any person against
any Losses by reference to any matter includes indemnifying and keeping that
person indemnified against all Losses from time to time made, suffered or
incurred as a direct or indirect consequence of or which would not have arisen
but for that matter;

(h)         when calculating the period of time before which, within which or
following which any act is to be done or step taken pursuant to this Agreement,
the date that is the reference date in calculating that period shall be
excluded. If the last day of that period is not a Business Day, the period in
question shall end on the next Business Day; and

(i)          reference to any statute or regulation includes any modification,
amendment or re-enactment that statute or regulation.

2.          Grant of rights / license

2.1        The Licensor, subject to the terms of this Agreement, grants to the
Licensee the exclusive, non-assignable (except in conjunction with an assignment
of this Agreement under Section 15) right and license to use the Licensor IPR
Package:

(a)         to Commercialize the Product in the Territory;

(b)         to Manufacture in any country the quantities of Product required for
Commercialization in the Territory; and

(c)         to Develop the Product for Commercialization in the Territory.

2.2        Subject to Section 15.2 and Section 2.3, the Licensee shall have the
right to sublicense its rights under the License to an Affiliate or Third Party
Sub-licensees without the consent of the Licensor, except in the case of a Third
Party where in one transaction or a series of related transactions Licensee
sublicenses substantially all of its rights under the License to such Third
Party.

2.3        The Parties agree that:

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(a)         prior to the grant of a sub-license pursuant to Section 2.2, the
Licensee shall serve written notice on the Licensor and such notice shall
contain the following information:

(i)          the identity of the proposed Sub-licensee; and

(ii)        the reasons why the Licensee believes such Sub-licensee will be able
to perform its obligation;

(b)         where the proposed sub-license is to a Third Party where in one
transaction or a series of related transactions Licensee seeks to sub-license
substantially all of its rights under the License to such Third Party and the
Licensor has a veto right under Section 2.2 above, then the notice to be
provided to the Licensor pursuant to Section 2.3(a) must be provided at least
six (6) weeks prior to entry into the proposed sub-license with such Third
Party; and

(c)         the Licensee (in its capacity as sub-licensor) shall remain
responsible for all of its obligations hereunder and if the acts or omissions of
any such Sub-licensee cause the Licensee to be in breach of this Agreement the
Licensee shall be responsible therefor (with all the express consequences
provided for under this Agreement and any implied consequences) regardless of
any remedy which the Licensee may have against the Sub-licensee. In particular
but without limitation, the Licensee shall perform its financial obligations
under this Agreement regardless of a breach by any Sub-Licensee.

2.4        During such time as either Party owes Royalties to the other Party
under this Agreement, each Party shall not, and shall procure that its
Affiliates and Sub-licensees shall not, directly or indirectly, Develop,
Manufacture or Commercialize in the Territory any product for assessing GHD in
adults or Children other than the Product.

2.5        During the Term the Licensee, its Affiliates and Sub-Licensees shall
refrain from:

(a)         seeking or accepting any actual or potential orders for the Product
that are known or are reasonably suspected to be for use outside the Territory
and the Licensee shall refer to the Licensor all inquiries that the Licensee
receives for the Product for sale or ultimate delivery outside the Territory; or

(b)         establishing any branch or maintaining any distribution depot for
the Product outside the Territory.

2.6        During the Term:

(a)         the Licensor, its Affiliates and licensees (other than Licensee)
shall refrain from seeking or accepting any actual or potential orders for the
Product that are known or are reasonably suspected to be for use inside the
Territory; and

(b)         the Licensor shall refer to the Licensee all inquiries that the
Licensor receives for the Product for sale or ultimate delivery inside the
Territory.

2.7        For clarity, nothing in this Section 2 shall limit or restrict the
Licensor, its Affiliates, or any Third Party licensee of the Licensor, from
using the Licensor IPR Package in connection with the development or
Commercialization of the Product outside of the Territory or in connection with
the Manufacture of the Product outside of the Territory or inside the Territory
for development or Commercialization outside the Territory.

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3.          Governance

3.1        With effect from the Effective Date the Parties shall establish and
run a Joint Steering Committee (“JSC”).

3.2        The JSC shall be organized as follows:

(a)         the JSC shall comprise four (4) persons (“JSC Members”) and the
Licensor and the Licensee respectively shall be entitled to appoint two (2) JSC
Members, including one person whose primary responsibility shall relate to
Development, to remove any JSC Member appointed by it and to appoint any person
to fill a vacancy arising from the removal or retirement of such JSC Member
appointed by it. JSC Members must be appropriate for the primary function of the
JSC in terms of their seniority, availability, function in their respective
organization, training and experience. There will be a chairperson (“JSC
Chairperson”) who will be one of the Licensee JSC Members;

(b)         the Licensee and the Licensor respectively shall each notify the
other of any change in the identities of their JSC Members. Both sides shall use
reasonable efforts to keep an appropriate level of continuity in representation.
JSC Members may be represented at any meeting by another person designated in
writing by the absent JSC Member;

(c)         JSC shall hold meetings in person as frequently as the members of
the JSC may agree shall be necessary, and otherwise by teleconference or a
video-conference, but no less frequently than four (4) times each Calendar Year
in total. Dates of meetings shall be agreed by the Parties not less than thirty
(30) days beforehand. Each Party shall submit the agenda items and associated
materials that it wishes to be considered no later than seven (7) days prior to
the meeting and it is agreed that Licensor JSC Members shall only be entitled to
submit agenda items for inclusion which relate to matters that have or could
potentially have a material impact on the Product, payments to be made pursuant
to this Agreement or the Licensor more generally. The first meeting of the JSC
will take place as soon as reasonably practicable after the Effective Date, but
in no event later than ninety (90) days after the Effective Date, at such
location as the members of the JSC may agree or, failing such agreement, Dublin,
Ireland. Special meetings of the JSC may be called by any JSC Member upon
reasonable written notice to the then current chairman of the JSC not more than
twice in any Calendar Year absent a material matter requiring JSC attention that
cannot reasonably be delayed until the next scheduled JSC meeting;

(d)         if not held by teleconference or videoconference, the venue for
meetings of the JSC shall be held at such location as the members of the JSC may
agree or, failing such agreement, Dublin, Ireland. Each Party shall be
responsible for its own expenses including travel and accommodation costs
incurred in connection with JSC meetings; and

(e)         the JSC Chairperson or its designee shall be responsible for
preparing the minutes of any JSC meeting as soon as reasonably practicable
thereafter, seeking unanimous approval of those minutes from the JSC Members,
signing and dating the approved minutes and distributing a copy of the signed
minutes to each Party.

3.3        The JSC shall have the following purposes:

(a)         as regards Commercialization:

(i)          to: (A) provide the Licensor with visibility into the
Commercialization of the Product in the Territory by the Licensee via reports
prepared in the ordinary course for the Licensee's internal purposes, provided
that such internal reports

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at a minimum provide the Licensor with the information set out in Section 7.2 at
least quarterly, failing which the Licensee shall deliver such information in
accordance with Section 7.2 irrespective of whether it is prepared in the
ordinary course or not; (B) procure that the Licensor has reasonable access to
Commercial Information of the Licensee relating solely to the Product; (C)
ensure that the Licensor is informed regarding acceptance of the Product and
Product quality complaints; and (D) provide a means for the Licensor to provide
input for any activities relating to Commercialization; and

(ii)        (to the extent materially relevant to the sale of the Product in the
Territory, to provide the Licensee with visibility into the Commercialization of
the Product outside the Territory by the Licensor, to include reasonable
information in relation to overall sales volume, market messaging, branding,
product positioning strategies, and the information to be provided to the
Licensee as specified in Section 7,

and otherwise to act as a forum for general liaison and communication between
the Parties in relation to Commercialization of the Product by the Licensee. It
is agreed that neither Party shall be required to provide copies of term sheets
or commercial agreements relating to grants to Third Parties of rights related
to the Product, by Licensee in the Territory, or by the Licensor outside the
Territory;

(b)         provide each Party with visibility into the other Party's
Development activities with respect to the Product other than in relation to the
PIP, and to provide a forum for discussion of such Development activities;

(c)         oversee and guide the Licensor's activities in carrying out the PIP,
to consider reports from the Licensor in respect of the PIP, to provide a means
for the Licensee to provide input and, where so provided hereunder, approval for
any activities relating to the PIP and for general liaison and communication
between the Parties in relation to the PIP;

(d)         review and approve with respect to the PIP (including any amendments
to any of the following):

(i)          the investigational medicinal Product Dossier;

(ii)        locations of Clinical Trial sites;

(iii)       the identity of principal investigators for the Clinical Trial
sites;

(iv)        the investigator brochure;

(v)         informed consent documentation;

(vi)        proposed amendments by the Parties to the PIP Budget (it being noted
that pursuant to Sections 3.5 and 5.5, the JSC may not increase the PIP Budget
without the written consent of both Parties);

(vii)      where a contract is to be entered into with a CRO in relation to the
Product after the Effective Date, the identity of and the proposed contract with
such CRO;

(viii)     the identity and contracts with major vendors (e.g. site monitors);
and

(ix)        protocols prepared by the Licensor for the PIP;

(e)         coordinate with respect to:

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(i)          the finalization of the each Party’s supply chain for the Product
for its respective Territory;

(ii)        the transition of responsibility for the Manufacture of the Product
for the Territory from the Licensor to the Licensee; and

(iii)       the general improvement of the supply chain of the Product, both
inside and outside the Territory,

and for general liaison and communication between the Parties in relation to the
Manufacture of the Product; and

(f)         shall perform such other functions and responsibilities as are given
to it under the express provisions of this Agreement but shall have no authority
to amend any commercial terms of this Agreement or any matter that would cause
any payments stated in this Agreement to be other than the amount of those terms
as stated herein.

3.4        Each Party shall give reasonable consideration to input provided by
the other Party to the JSC on all matters set forth in Section 3.3, provided
however that the JSC shall have authority to make decisions solely with respect
to the PIP. Such decisions shall be made by unanimous agreement of the JSC
Members wherever possible with the Licensee JSC Members together having one vote
on behalf of the Licensee and the Licensor JSC Members together having one vote
on behalf of the Licensor. Both Parties will use their reasonable efforts to
build consensus. All decisions of the JSC shall be minuted by or on behalf of
the JSC Chairperson who shall seek unanimous approval of those minutes from the
JSC Members, sign and date the approved minutes and promptly send a copy of the
minutes of each JSC meeting to both Parties. The JSC shall exercise this
authority in good faith and in accordance with the terms of this Agreement, and
any decision by the JSC on such matters made in accordance with this Section 3.4
shall be binding upon the Parties. Subject to Section 3.5 below:

(a)         in the event that agreement on a PIP-related decision cannot be
reached within thirty (30) days, the matter shall be referred for resolution by
negotiation between a representative appointed by Licensor, and for Licensee,
the President and CEO of Strongbridge Biopharmaceuticals plc or his/her
designee, and if the executives cannot reach agreement on the issues under
consideration within ten (10) Business Days, then the matter shall be referred
to a Third-Party pharmaceutical executive mutually and reasonably agreeable to
the Parties and having no less than ten (10) years’ experience directing
biopharmaceutical product development programs as set forth in Section 3.4(b);

(b)         Expedited Expert Referral.

(i)          the Parties shall agree to the identify of such Third-Party
pharmaceutical executive as promptly as practicable and in no event later than
ten (10) days following the expiration of the ten (10) day period set forth in
Section 3.4(a);

(ii)        not later than ten (10) days following the expiration of the ten
(10) day period set forth in Section 3.4(b)(i), each Party shall submit to the
Third-Party pharmaceutical executive (with a copy to the other Party) a position
paper setting forth the desired decision on the applicable matter and the
rationale for such desired decision, including any supporting documentation
provided to the JSC in relation to the matter under consideration thereto, such
position paper not to exceed 5000 words (not including supporting
documentation);

(iii)       the Parties shall request the Third-Party pharmaceutical executive
to render, not later than ten (10) days following the expiration of the ten (10)
day period

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set forth in Section 3.4(b)(ii) (or such other time to which the Parties and
such executive may all agree), a decision in good faith and based solely on the
arguments set forth in such position papers (and for the avoidance of doubt,
neither Party shall be permitted to contact the Third-Party pharmaceutical
executive to provide additional information or arguments), and such decision
shall be restricted to the one of the desired outcomes set forth in the
respective position papers of the Parties, and shall render such decision
without providing more than the identity of the Party whose desired outcome
constitutes such decision;

(iv)        such decision by the Third-Party pharmaceutical executive shall be
final and binding on the Parties; and

(v)         the Party whose desired outcome is not adopted by the Third-Party
pharmaceutical executive shall be responsible for payment of the fee owed to the
Third-Party pharmaceutical executive .

3.5        The Parties agree that in no event shall the JSC or any dispute
resolution process have the authority to increase the PIP Budget without the
express written consent of both Parties in accordance with Section 5.5.

4.          Technology transfer and technical / regulatory assistance1

The Licensor shall:

(a)         maintain the Data Room until the first anniversary of the Effective
Date (the “Closure Date”) and shall give nominated representatives of the
Licensee access to such Data Room;

(b)         as soon as reasonably practicable following the Closure Date, the
Licensor shall provide to the Licensee two identical CD-ROM discs on which are
contained copies of all Documents contained, on the Closure Date, within the
Data Room;

(c)         in accordance with the timing set forth in Schedule 2, to the extent
not already in the Data Room, make available to the Licensee the Know How
Controlled by it, the Dossier filed in respect of the NDA and the Commercial
Information Controlled by it and details about the Licensor Trademarks and
Licensor Patent Rights, including those items set forth on Schedule 2. Licensor
shall provide those materials as soon as reasonably practicable after the
Effective Date, and in no event later than any time specified on Schedule 2 for
any particular item set out thereon; and

(d)         immediately following execution of this Agreement, and before
transfer of the Product Registrations (NDA, IND, ODD), provide the Licensee with
a CD-ROM disc or discs containing all FDA correspondence related to these
applications and the complete electronic copy of the NDA, IND and ODD in the
exact format and active file links as submitted to the FDA in respect of the NDA
and IND and as pdf files in respect of the ODD. This should include the FDA
submission acknowledgements if filed electronically.

(e)         provide not later than six months after the Effective Date the
transfer of a copy of the electronic Trial Master File(s) for the NDA supporting
studies.

 

 

 

 

 

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1         Note to draft:  Parties to discuss and determine how to handle the
preservation of and access of Licensee to any clinical samples held by Licensor.

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5.          Development

Development Plan

5.1        In each Calendar Year that Development regarding the PIP is
occurring, each Party shall at its own cost and expense (subject to Section 5.4)
use Commercially Reasonable Efforts to carry out the activities specified in the
Development Plan in relation to the PIP as the responsibility of such Party so
as to meet the timelines set out in them.

5.2        During the period of Development regarding the PIP by the Licensor,
it shall update the Development Plan on or before November 1st in each year and
shall submit the same to the JSC for review and approval.

PIP

5.3        The Licensor shall:

(a)         be responsible for the conduct of the PIP, subject to and in
accordance with the timelines set out in the Development Plan and subject to the
direction of the JSC;

(b)         conduct all activities in relation to the PIP in compliance with all
Legal Requirements, ethics committee, informed consent or similar approvals in
relation thereto, and in compliance with GCP;

(c)         provide periodic updates regarding the PIP to the JSC as reasonably
requested by the JSC;

(d)         permit Licensee (at its own cost) and upon reasonable notice to
audit, during normal business hours, the trial master file and shall cooperate
with any such audit; and

(e)         promptly provide to the JSC the results of the PIP in the form of a
copy of any Interim Report, a Formal Presentation and a copy of the Final Report
as these occur, even if between JSC scheduled meetings.

5.4        The Licensee shall reimburse the Licensor for seventy per cent (70%)
of the ongoing documented Development Costs reasonably incurred by the Licensor
in accordance with the Development Plan and the PIP Budget. The Licensee shall
reimburse its proportion of the Development Costs not later than sixty (60) days
following receipt of the Licensor's invoices and supporting evidence of such
Development Costs having been incurred in connection with the conduct of the
PIP, which the Licensor shall submit as and when such Development Costs arise
but no more frequently than on a quarterly basis, save where an invoice is for
an amount equal to or greater than $100,000 whereupon the Licensor shall be
permitted to invoice on a monthly basis. Payment shall be made by the Licensee
within thirty (30) Business Days of the date of receipt of the Licensor's
invoice, into such bank account as the Licensor shall specify from time to time.
For the avoidance of doubt, the Licensor shall be responsible for the remaining
thirty per cent (30%) of such Development Costs in connection with the conduct
of the PIP.

5.5        During the period in which the PIP is ongoing, the Parties may, from
time to time, together agree in writing to update the PIP Budget and where this
occurs the proposed changes will be submitted to the JSC for review and
discussion. Once agreed by the Parties in writing, the revised PIP Budget shall
be the 'PIP Budget' for the purposes of this Agreement.

5.6        Upon a Bankruptcy Event of Licensor, Licensee shall have the right,
but not the obligation, to assume full control of the PIP upon written notice to
Licensor. Following any such notice, Licensor shall, to the extent permitted by
Law, use its reasonable endeavors to promptly assign to Licensee or its designee
all contracts associated with the PIP and shall cooperate

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with Licensee to ensure a smooth transition of control of the PIP to Licensee,
including by executing such documents requested by Licensee as are necessary to
enable such transition. Licensee shall thereafter carry out the PIP as set forth
in the Development Plan on behalf of itself with respect to the Territory and on
behalf of Licensor outside the Territory. Licensee shall pay Licensor's thirty
percent (30%) share of the cost and expenses of the PIP as set forth in the PIP
Budget and shall be entitled to deduct all such costs and expenses from any
amounts of royalties or milestones owed to Licensor hereunder prior to making
any payments to Licensor.

Development other than the PIP

5.7        Except as expressly set forth above in relation to the PIP and
subject to Section 5.7 below, each Party shall:

(a)         be responsible for the conduct and all associated costs and expenses
of the Development activities for the Product in its own territory and for the
avoidance of doubt 'territory' shall mean the USA and Canada for the Licensee
and the rest of the world for the Licensor;

(b)         conduct all such Development activities in compliance with all Legal
Requirements, ethics committee, informed consent or similar approvals in
relation thereto, and in compliance with GCP;

(c)         provide the JSC with a summary and update in reasonable detail of
such Development activities at each meeting of the JSC; and

(d)         provide the other Party with a copy of a near-final draft of each
Clinical Trial protocol or update to a protocol for the Product at least
forty-five (45) days prior to the date on which such protocols or updates are
provided to any Regulatory Authority or Clinical Trial site, in order to permit
such other Party to comment on such protocol or update, and shall reasonably
consider in good faith any comments thereon provided by such other Party within
thirty (30) days following such other Party's receipt of such copy of such
protocol or update.

5.8        The Parties agree that where any Development activity of the Licensee
is, in the Licensor's reasonable opinion, going to have a material adverse
impact on the Development, Manufacture or Commercialization of the Product
outside of the Territory for the Existing Indications, then the prior written
consent of the of the Licensor will be required, such consent not to be
unreasonably withheld, delayed or conditioned.

5.9        If Licensee wishes to Develop Product in the Territory for a New
Indication, Licensee shall have the right to do so on the following conditions:

(a)         the Licensee shall be solely responsible for the costs and expenses
of the Development activities;

(b)         the Licensee shall supply the Licensor with all material Know How,
Dossiers and other Licensee IPR Package relating thereto, including a copy of
each Final Report promptly following its preparation;

(c)         subject to paragraph 5.9(d), the Licensee hereby grants to the
Licensor a perpetual, irrevocable, exclusive, sub-licensable, right and license
to use the Licensee IPR Package for the Product for such New Indication to
Develop, manufacture and Commercialize the Product outside the Territory; and

(d)         Licensor shall pay royalties to Licensee under such license on the
same payment terms as, and at a rate equal to two percent (2%) less than the
rate owed by, Licensee

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to Licensor for sales of Products hereunder, with all applicable definitions and
provisions having the Parties reversed, mutatis mutandis.

Regulatory Approvals

5.10      Assignment of the NDA and Domain Names.

(a)         Subject to the terms and conditions set out in this Agreement,
Licensor hereby sells, conveys, and transfers to Licensee, and Licensee hereby
purchases and accepts the sale, conveyance and transfer of all of Licensor's
right, title and interest in the Product Registrations (including the NDA and
the IND and orphan designation with respect thereto, and all copyrights, data
and information contained therein), and the domain names set forth on Schedule
6, in the Territory on the Effective Date, subject to Licensor’s express right
to return of the Product Registrations and domain names upon certain
terminations of the Agreement as set forth in Section 14.

(b)         Promptly after the Effective Date, each Party shall file with the
FDA letters and applications in compliance with 21 CFR § 314.72 in the forms set
forth on Schedule 3 in order to record with the FDA the change in ownership of
the NDA from Licensor to Licensee.

(c)         Promptly following the first Marketing approval for a Product
outside the Territory, to the extent permitted by applicable Law, Licensee shall
ensure that any internet users from outside the Territory who access the domain
names listed on Schedule 6 (or any variants of these that are now or in the
future become owned by the Licensee or an Affiliate or agent of the Licensee),
are redirected to Licensor’s website or another website designated by Licensor
covering the Licensor Product outside the Territory, provided that Licensor
shall provide a link on such website with reasonably prominent instructions so
that visitors to its site from inside the Territory or otherwise with an
interest in the Product in the Territory are directed to jump to Licensor’s
website or another website designated by Licensor covering the Licensor Product
inside the Territory.

5.11      The Licensee shall:

(a)         subject to Section 5.11(b) below, at its sole cost and expense
(subject to Section 5.3 with respect to costs of the PIP), use Commercially
Reasonable Efforts to obtain any further Regulatory Approvals for the Product
and any Pricing Approval required or commercially desirable in each country of
the Territory, and such Regulatory Approvals shall, in all instances, be
obtained by the Licensee in its own name and the Licensor shall provide its
reasonable assistance to the Licensee to enable the Licensee to obtain the
Regulatory Approvals in the Licensee's name; and

(b)         use Commercially Reasonable Efforts following the Effective Date to
obtain Regulatory Approval for the Product in Canada for the Adult Indication.

5.12      The Licensee shall:

(a)         conduct all Development activities (other than the PIP which is the
responsibility of the Licensor) in the Territory in compliance with all Legal
Requirements;

(b)         be responsible for the preparation of all submissions for the grant
of a Regulatory Approval in the Territory; and

(c)         as soon as reasonably practicable following its receipt of the final
study report for the last necessary clinical trial for the PIP, prepare and make
all submissions for the grant

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of Regulatory Approval in each country in the Territory for the Product for the
Pediatric Indication using Commercially Reasonable Efforts.

5.13      The Licensee shall be responsible for all filings and submissions in
respect of Regulatory Approvals for the Product in the Territory as well as
attending all meetings with Government Authorities and Regulatory Authorities in
respect thereof and:

(a)         shall provide, at the request of the Licensor, copies of all
material proposed filings, in advance of the filing or submission thereof, for
review and comment by the Licensor. The Licensee shall consider in good faith in
its revision of the filing or submission, any comments made by Licensor; and

(b)         shall inform the Licensor in advance of all meetings or conference
calls with the Regulatory Authorities with respect to Products including on
Pricing Approval issues and one Licensor representatives shall have the right to
attend solely as a non-participating observer in the meeting, to the extent
permitted by such Regulatory Authorities.

5.14      The Licensee shall, from the Effective Date, use Commercially
Reasonable Efforts to maintain the orphan status of the NDA Product.

6.          Supply

CMO Contracts

6.1        An illustration of the Licensor's proposed supply chain for the
Product for the USA is set out in Schedule 8 of this Agreement (the “Supply
Chain”). Certain of the CMO Contracts that comprise the Supply Chain have been
entered into by the Licensor or its Affiliates as of the Effective Date (the
“Existing CMO Contracts”) while others have not been concluded as at the
Effective Date (the “Outstanding CMO Contracts”). The Licensee shall use
Commercially Reasonable Efforts to procure a full supply chain of the Product
for the USA to enable the launch of the Product as soon as reasonably
practicable after the Effective Date and the Licensee shall provide such
reasonable assistance as the Licensor may reasonably request, subject to the
provisions of Section 6.3(f).

6.2        The Parties agree that the Licensor shall not be required to assign,
transfer or novate any of the Existing CMO Contracts to the Licensee but the
Parties shall have a joint option (meaning, for the avoidance of doubt, that
both Parties must consent to the assignment, transfer or novation) to do so,
which is jointly exercisable at any time within 90 days of the Effective Date.
The Licensee shall:

(a)         in respect of the Outstanding CMO Contracts, be entitled to enter
into negotiations with the relevant CMOs in respect of such contracts, in place
of the Licensor, and conclude such contracts in its own name or that of an
Affiliate; and

(b)         in respect of the Existing CMO Contracts, negotiate in good faith
with the Licensor's CMOs or with alternative Third Party manufacturers with the
intention of concluding its own direct terms with such CMOs or Third Party
manufacturers,

and the contracts which the Licensee enters into pursuant to Sections 6.2(a) and
(b) are together the “Licensee CMO Contracts”.

6.3        The Parties agree that:

(a)         the Licensor shall provide to the Licensee such reasonable
assistance as the Licensee shall reasonably request to help the Licensee to
enter into the Licensee CMO Contracts;

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(b)         they shall work together in good faith following the Effective Date
to ensure that, where they both use common CMOs in their respective supply
chains, that they leverage volume discounts from such common CMOs when ordering
Materials;

(c)         each Party shall use reasonable efforts to ensure that they do not
enter into any contract with a shared contracting party that disadvantages the
other Party in such other Party’s dealing with such contracting party;

(d)         each Party’s contracts with shared suppliers shall provide that in
the event of a shortage or other restriction on the supply of a commonly
purchased material from such suppliers, the supplier, as between the Parties,
shall allocate available supply pro rata to the Parties based upon each Parties
forecasts for such material in place prior to any knowledge of a potential or
actual shortage thereof;

(e)         if the Licensor and Licensee together choose to exercise the joint
option (meaning, for the avoidance of doubt, that both Parties must consent to
exercise of the option) referred to in Section 6.2 then the Parties shall,
through the JSC, work together to assign, transfer or novate the Existing CMO
Contracts to the Licensee whereupon such Existing CMO Contracts shall become
Licensee CMO Contracts; and

(f)         the Licensee shall reimburse the Licensor for all reasonable costs
and expenses (including employee costs which shall be charged on an hourly
basis) associated with assistance requested by Licensee from and provided by the
Licensor (or its Affiliates or any of their respective employees or consultants)
pursuant to this Section 6.

Interim Licensor Supply Arrangements

6.4        The Parties will co-operate and work in good faith during the
transition period following the Effective Date, as regards supply arrangements.
More particularly, and subject to Sections 6.5 and 6.6 below, insofar as the
Licensee requires Materials for the Manufacture of the Product under any
Existing CMO Contract then, for the period from the Effective Date until the
date upon which the Licensee enters into the relevant Licensee CMO Contract
(“Licensor Supply Period”):

(a)         the Licensor shall procure that the relevant CMO supplies Materials
to the Licensee or one of its Affiliates or CMOs, subject to the terms and
conditions of such Existing CMO Contract, for the purposes of Manufacture by the
Licensee or one of its Affiliates or CMOs of the Product for the Territory;

(b)         the Licensor shall procure that the Licensor Materials set forth on
Schedule 4 to be delivered to the Licensor, are instead delivered to such
location as the Licensee notifies to the Licensor in writing prior to that date,
and the Licensee shall within 10 Business Days of receipt of any such Licensor
Material, pay to the Licensor an amount equal to the amount set forth on
Schedule 4 for the corresponding Licensor Material so received by Licensee;

(c)         the Licensor shall not, during the Licensor Supply Period, terminate
the relevant Existing CMO Contract or amend it in a manner which would be
adverse to the interests of the Licensee; and

(d)         the Licensor shall, at Licensee’s cost and expense, take such
actions in respect of such Existing CMO Contract as the Licensee may reasonably
request, including where a CMO is in breach of the terms of an Existing CMO
Contract, to enforce its rights against such CMO for and on behalf of the
Licensee.

6.5        The Parties agree that:

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(a)         the liability of the Licensor to the Licensee pursuant to Section
6.4(a), shall be limited, in all instances other than a liability arising from
the negligence or willful misconduct of the Licensor in connection with the
performance of its obligations under Section 6.4(a), to the amount actually
recovered by the Licensee from the relevant CMO;

(b)         Licensor, promptly upon receipt thereof, shall send by electronic
means copies of all invoices in respect of Materials supplied by the Licensor
pursuant to Section 6.4(a) of this Agreement, which invoices Licensee shall pay
on behalf of Licensor in accordance with the payment terms thereof, provided
that if Licensee fails to make any such payment of a timely sent invoice copy
for amounts not in dispute by Licensee (including invoices or portions of
invoices previously but no longer in dispute), Licensor shall be entitled to pay
such invoice (including any penalty or interest owed as a result of late payment
thereof ) and to invoice Licensee for such payment, which Licensee shall pay to
Licensor promptly. Licensee shall indemnify the Licensor and its Affiliates in
respect of any claim made by a CMO against the Licensor as a result of the
Licensee's failure to make any payments due to a CMO (including any disputed
amounts that the Licensee incorrectly disputes); and

(c)         the Licensor shall not be required to comply with its obligations
pursuant to Section 6.4 to the extent that this would breach any applicable Laws
and/or which would put it in breach of its obligations under any Existing CMO
Contract.

6.6        The Parties agree that:

(a)         the Licensee shall use Commercially Reasonable Efforts to take full
responsibility for and management of supply of Products in the Territory as soon
as reasonably practicable following the Effective Date; and

(b)         to the extent that the Licensee does not take responsibility for and
management of supply of Products by the date which is twelve (12) months from
the Effective Date, then:

(i)          the Parties shall enter into a supply agreement to govern such
supply arrangements between the Parties (the "Supply Agreement"); and

(ii)        subject to the terms of the Supply Agreement, the Licensor shall
have no further obligations under Sections 6.4 - 6.9 of this Agreement (which
relate to the interim supply arrangements); and

(c)         with effect from the end of the Licensor Supply Period (or, if
earlier, the date which is 9 months from the Effective Date), the Licensee shall
either itself or through the Supply Agreement be responsible for supply, and
shall manage the Manufacturing of all Materials and Product for sale in the
Territory.

For the avoidance of doubt, the Licensor shall be responsible for and shall
manage the Manufacturing of all Materials and Product for sale in countries
outside of the Territories.

6.7        During the Licensor Supply Period, the Licensor will provide letters
of access allowing access for the Licensee to the extent possible to the
production sites of its CMOs, in each case where Materials have been
manufactured for the Licensee pursuant to Section 6.4, in order to enable the
Licensee to visit such sites and to review the Manufacturing and any
documentation relating to the Materials or its Manufacturing maintained at such
site to the extent necessary or required by applicable Law or the requirements
of any Regulatory Authority or to prepare for any investigation or inspection
that may be carried out by any Regulatory Authority.

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6.8        The Parties shall cooperate and discuss in good faith with a view to
agreeing a plan (including timeline and a detailed description of all
documentation containing Manufacturing Know-How that will need to be provided to
the Licensee) for the successful transfer of the Manufacturing Know-How
Controlled by the Licensor to the Licensee during the Licensor Supply Period and
on an ongoing basis thereafter in order to assist the Licensee in Manufacturing
or having Manufactured the Product. Licensor agrees to make a technical transfer
of any Manufacturing Know-How existing as of the Effective Date or created at
any point during the Term which it Controls to the Licensee in accordance with
the timelines agreed in any technical transfer plan (with respect to
Manufacturing Know-How in existence as of the Effective Date and Controlled by
Licensor) and within such time as is reasonably practicable after creation of
such Manufacturing Know-How or upon the Licensor becoming aware of the existence
of such Manufacturing Know-How (with respect to Manufacturing Know-How created
or discovered during the Term). The Licensee agrees to make a technical transfer
of any Licensee Manufacturing Know-How which it Controls created at any point
during the Term to the Licensor within such time as is reasonably practicable
after creation of such Licensee Manufacturing Know-How or upon the Licensee
becoming aware of the existence of such Licensee Manufacturing Know-How. Except
as set forth in Section 6.9, the costs of the transfer of Manufacturing Know-How
shall be shared equally by the Parties.

6.9        For any change in a Manufacturing process or Material used for the
Product (including the Product, itself) that are made as a result of a
requirement of at least one Regulatory Authority in the Territory and at least
one Regulatory Authority outside the Territory, the parties agree to split all
costs and expenses related to developing and implementing such change (but not
the cost of any Material used in the Product) with Licensee bearing seventy
percent (70%) of such costs and expenses and Licensor bearing thirty percent
(30%) of such costs and expenses

Licensee Supply of Materials

6.10      Where the Licensor seeks to obtain Product or Materials for the
Manufacture of the Product for outside the Territories from the Licensee, then
the Parties shall negotiate in good faith to enter into a supply agreement for
such Product and/or Material on commercially reasonable terms.

PIP

6.11      Notwithstanding any other provision of this agreement, where the PIP
is fully or partially conducted in the Territory, the Licensor shall be entitled
to supply to the relevant Third Parties assisting with the PIP such amount of
CTM as is necessary for the PIP.

7.          Commercialization.

7.1        Licensee shall either itself or through its Affiliates, and
Sub-licensees Commercialize the Product in the Territory using Commercially
Reasonable Efforts and 'Commercially Reasonable Efforts' for these purposes
shall include, but not be limited to the Licensee:

(a)         as soon as reasonably practicable following the Effective Date
hiring, at a minimum, 15 field specialists whose role shall solely relate to the
Product and maintaining such minimum number of field specialists for at least
the 12 month period following the first Launch; and

(b)         ensuring, that notwithstanding the resources required by the
Licensee for the preparation for and the launch of another product by the
Licensee (or its Affiliates), it continues to provide an appropriate level of
resources dedicated to the Commercialization of the Product.

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Information Sharing

7.2        The Licensee shall provide Licensor through the JSC with reports and
other commercialization planning documents for the Product as are generated in
the ordinary course for the Licensee's internal purposes. To the extent that
such ordinary course reports and planning documents do not provide the Licensor
with the following information on a quarterly basis, the Licensee shall be
required to provide such information to the Licensor upon a quarterly basis:
current sales forecasts and actual volume of sales of the Product in the
Territory, the number of specialist sales staff dedicated wholly or partially to
the Commercialization of the Product, any material decrease in either from time
to time and the reasons therefor and the nature and scale of promotional
activities in the Territory.

Pricing

 

7.3        Licensee will use Commercially Reasonable Efforts to secure required
Pricing Approval for the Product in the Territory for each Existing Indication.
The Licensee will have sole authority for determining and establishing the price
and terms of sale (including any rebates or discounts) of Product in the
Territory. Each Party shall provide the other Party with copies of any material
Documents or other material pertaining to Pricing Approvals in such providing
Party’s respective territory.

Promotional Materials

7.4        The Licensee or its Affiliates or Sub-licensees will be responsible
for the creation, preparation, production and reproduction of all Promotional
Materials and for filing, as required by Legal Requirements, all Promotional
Materials with Regulatory Authorities in the Territory. Subject to Section 9,
the Licensee shall use its own corporate name and/or logo or those of an
Affiliate on Promotional Materials in connection with Commercialization of
Product in the Territory, unless otherwise mutually agreed by the Parties.

Promotional claims/compliance

7.5        The Licensee shall not promote the Product for intended uses or
indications other than those in the labelling as approved by the Regulatory
Authority in the Territory from time to time nor shall the Licensee make any
medical or promotional claims for any Product other than as permitted by Legal
Requirements (which for the avoidance of doubt shall include the False Claims
Act). When distributing information related to any Product or its use for the
Existing Indications in the Territory (including information contained in
scientific articles, reference publications and publicly available healthcare
economic information), the Licensee must comply with all Legal Requirements
(which for the avoidance of doubt shall include the False Claims Act) in the
applicable country.

International Congresses / Symposia

7.6        For international congresses or symposia:

(a)         where Licensee wishes to have a presence in a symposium or congress
outside the Territory regarding the Product, Licensee shall notify Licensor in
advance of Licensee's proposed presence, providing reasonable detail regarding
such planned presence and seeking Licensor’s consent (such consent not to be
unreasonably withheld, delated or conditioned) for such presence. Licensor, as
soon as reasonably practicable, but in no event later than ten (10) days after
receiving such notice, shall notify Licensee of Licensor either withholding
consent (with the reasons therefor) or providing consent to such presence;

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(b)         where Licensor wishes to have a presence in a symposium or congress
inside the Territory regarding the Product, Licensor shall notify Licensee in
advance of Licensor's proposed presence, providing reasonable detail regarding
such planned presence and seeking Licensee’s consent (such consent not to be
unreasonably withheld, delated or conditioned) for such presence. Licensee, as
soon as reasonably practicable, but in no event later than ten (10) days after
receiving such notice, shall notify Licensor of Licensee either withholding
consent (with the reasons therefor) or providing consent to such presence; and

(c)         The Parties shall, to the extent reasonable and practicable,
coordinate attendance at such conference or symposium (including displaying
brand names, trademarks and logos for the Product, to the extent permitted by
Law).

Product Complaints

7.7        The Licensee will be responsible for responding to product complaints
regarding Product in the Territory and the Licensor for responding to product
complaints regarding Product outside the Territory. If the Licensor receives
complaints about Product for a country in the Territory, it will refer such
complaints to the Licensee (and vice versa), and the Licensee will be
responsible for responding thereto (and vice versa). Each Party shall, in all
instances, keep the other fully appraised of matters in relation to such product
complaints including by providing copies of all correspondence with the
complainant.

Medical and consumer inquiries

7.8        The Licensee will be responsible for responding to medical questions
or inquiries from members of the medical and paramedical professions and
consumers regarding Product in the Territory in accordance with Laws. If the
Licensor receives questions about Product for a country in the Territory, it
will refer such questions to the Licensee, and the Licensee will be responsible
for responding thereto. Each Party shall, in all instances, keep the other Party
reasonably appraised of matters in relation to any such questions or inquiries
that are material and/or frequently asked, including by providing copies of
correspondence with the relevant members of the medical or paramedical
professions or consumers.

Compliance with Laws

7.9        Each Party will perform its obligations under this Agreement in
accordance with all Laws. Each Party shall obtain from the requisite Government
Authorities any consents, licenses, permits, waivers, approvals, authorizations,
clearances, registrations or orders required to be obtained or made by such
Party in connection with the authorization, execution and delivery by such Party
of this Agreement and its performance of its obligations under this Agreement
including but not limited to the importation, exportation, sale and distribution
of the Product.

Regulatory affairs

7.10      Post-Approval Regulatory Submissions.

(a)         Subject to Section 7.10(b) below, as between the Parties, Licensee
shall have sole responsibility, at its own expense, for preparing, filing and
maintaining all Regulatory Submissions for Product in the Territory after the
Effective Date, including Regulatory Submissions in connection with Development
activities hereunder (collectively, “Post-Approval Regulatory Submissions”).
Licensee shall use Commercially Reasonable Efforts to compile, submit and
prosecute all Post-Approval Regulatory Submissions, in a format acceptable to
the applicable Regulatory Authorities in the Territory. All Post-Approval
Regulatory Submissions for Product in the Territory shall be filed in the name
of Licensee. Licensee shall be responsible for

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all communications and other dealings with the Regulatory Authorities relating
to the Post-Approval Regulatory Submissions and Licensee shall be the legal and
beneficial owner of all Post-Approval Regulatory Submissions.

(b)         Prior to submitting a Post-Approval Regulatory Submission regarding
a material matter (such as a supplemental change to the NDA), Licensee shall
provide a draft (which may be wholly or partly in electronic form) to the
Licensor for review and comment.

7.11      Adverse Event Reporting.

(a)         Licensor shall be responsible for complying with all Legal
Requirements governing adverse events both inside and outside the Territory that
occur prior to the transfer of NDA to Licensee, and Licensor's responsibilities
shall thereafter continue outside the Territory. Licensor shall submit copies of
reports of adverse events to Licensee simultaneously with submission to the
applicable Regulatory Authorities, and, following, transfer of the NDA to
Licensee, Licensee shall submit copies of adverse events to Licensor
simultaneously with submission to the applicable Regulatory Authorities in the
Territory. Licensee shall be responsible for complying with all Legal
Requirements governing adverse events in the Territory that occur after the
transfer of the NDA to Licensee. Each Party shall notify the other in a timely
manner and in any event within forty eight (48) hours of receiving any notice
from a Regulatory Authority, independent review committee, data safety
monitoring board or another similar Clinical Trial or post-marketing monitoring
body alleging concern regarding a patient safety issue or other material
information relevant to the safety or efficacy of Product.

(b)         As will be more fully set forth in the Safety Agreement and agreed
to pursuant to Section 7.11(d), Licensor shall be responsible at its own cost
for establishing and maintaining a global safety database for the Product based
on procedures and guidelines so agreed by the Parties for the operation of such
database.

(c)         If during the Product’s Development or Commercialization, the
Product becomes subject to adverse effects or information of the type referred
to in the last sentence of Section 7.11(a) is received, in each case which
Licensee, in good faith, reasonably believes would seriously impact the
long-term viability of Product in the Territory, Licensee shall determine
whether or not there exists such serious impact on the long-term viability of
such Product and, what if anything, the Parties should do to address the matter.
If Licensee, upon consideration of the relevant facts and in its sole
discretion, determines that the Parties are unable to successfully address and
resolve the safety issue, Licensee shall provide written notice to Licensor of
such determination, which notice shall set forth the reasons therefor, and
Licensee may terminate its rights and obligations under this Agreement upon
written notice.

(d)         As promptly as practicable following the Effective Date, but in no
event later than one hundred eighty (180) days thereafter, Licensee and Licensor
will develop and agree upon safety data exchange procedures in a separate and
detailed safety agreement (the “Safety Agreement”). Such agreement will describe
the coordination of collection, investigation, reporting, and exchange of
information concerning adverse events or any other safety problem of any
significance, and product quality and product complaints involving adverse
events, sufficient to permit each Party, its Affiliates, licensees or
sublicensees to comply with its legal obligations. The safety data exchange
procedures will be promptly updated if required by changes in Legal
Requirements. In the event of any conflict or inconsistency between this
Agreement

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and the Safety Agreement with respect to: (i) safety-related matters, the Safety
Agreement shall prevail; and (ii) any other matter, this Agreement shall
prevail.

7.12      Regulatory Correspondence.

(a)         Notification to Other Parties of Regulatory Correspondence. Each
Party shall promptly (and in any event, within two (2) Business Days of the date
of receipt of notice) notify the other Party in writing of, and shall provide
the other Party with copies of, any correspondence and other documentation
received or prepared by such Party in connection with any of the following
events:

(i)          receipt of a material regulatory letter, warning letter, Form 483,
or similar item, from any Regulatory Authority directed to the Manufacture,
packaging, and/or storage of Product, any Licensee facility or any contract
Manufacturing facility associated with Licensee's supply of Product;

(ii)        any recall or correction of any batch of Product; and

(iii)       any regulatory comments relating to Product requiring a response or
action by a Party.

(b)         Regulatory Correspondence requiring a Licensor response. In the
event that Licensor receives any material regulatory letter or comments from any
Regulatory Authority directed to its development or Manufacture of Product
requiring a response or action by Licensor, including, but not limited to,
receipt of a Form 483 or a warning letter, Licensee (as applicable) will
promptly provide Licensor with any data or information in Licensee's possession
that is required by Licensor in preparing any response relating to Licensor's
development of such Product, and will cooperate with Licensor's reasonable
requests related to Licensor preparing such response.

(c)         Regulatory Correspondence requiring a Licensee response. In the
event that Licensee receives any material regulatory letter or comments from any
Regulatory Authority relating to the development or Manufacture of Product,
Licensor (as applicable) will promptly provide Licensee with any data or
information required by Licensee in preparing any response relating to
Licensor's development or Manufacture of Product, and will cooperate fully with
Licensee in preparing such response. To the extent reasonably practicable
(subject to the time a response is mandated), Licensee shall provide Licensor
with a copy of each such response for Licensor's review and comment at least two
(2) Business Days prior to Licensee's submission of the response.

7.13      Regulatory updates. During the Term, each Party will keep the other
Party generally apprised of the status of any Regulatory Submissions related to
Product inside and outside the Territory. Licensee shall immediately notify
Licensor in writing upon receipt by Licensee of any Regulatory Approval to
market Product in the Territory. Licensor shall immediately notify Licensee in
writing upon receipt by Licensor of any Regulatory Approvals to market Product
outside the Territory.

8.          Financial Provisions

Upfront fee

8.1        The Licensee will pay to the Licensor an upfront fee of twenty four
million USD (US$24,000,000) within five (5) days of the Effective Date.

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Regulatory Milestone Payment

8.2        The Licensee will pay to the Licensor a milestone payment of five
million USD (US$5,000,000) within thirty (30) days of the grant of Regulatory
Approval in the USA for the Product for the Pediatric Indication.

Commercial Milestone Payments

8.3        The following one-time payments shall be paid by the Licensee to the
Licensor in USD sixty (60) days following first achievement of the following
Commercialization milestone events:

(a)         cumulative Net Sales of Product in a Calendar Year reaching twenty
five million dollars: Commercialization payment of four million dollars
(US$4,000,000);

(b)         cumulative Net Sales of Product in a Calendar Year reaching fifty
million dollars: Commercialization payment of ten million dollars
(US$10,000,000);

(c)         cumulative Net Sales of Product in a Calendar Year reaching one
hundred million dollars: Commercialization payment of twenty million dollars
(US$20,000,000);

(d)         cumulative Net Sales of Product in a Calendar Year reaching two
hundred million dollars: Commercialization payment of forty million dollars
(US$40,000,000); and

(e)         cumulative Net Sales of Product in a Calendar Year reaching five
hundred million dollars: Commercialization payment of one hundred million
dollars (US$100,000,000).

8.4        Each of the milestone payments subject to Sections 8.2 and 8.3, shall
only be payable by the Licensee upon the first occurrence of the applicable
event whenever it occurs. Upon the occurrence of the applicable event the
milestone payment shall be payable even if more than one occurs in a Calendar
Year. Such milestone payments are non-refundable in any circumstances whatsoever
and are not creditable against the royalties due under Section 8.6.

8.5        The Licensee shall report the occurrence of each milestone event
under Sections 8.2 and 8.3 to the Licensor within forty-five (45) days of its
occurrence and at the same time shall make the milestone payment to the Licensor
for which Sections 8.2 and/or 8.3 provides.

Royalties; Taxes

8.6        The Licensee will pay to the Licensor royalties during the Royalty
Term as set forth below:

Royalty = A + B where:

A equals fifteen per cent (15%) of that portion of Net Sales of Product in the
Territory, which, during the Calendar Year in question, is less than or equal to
seventy five million USD (US$75,000,000); and

B equals eighteen per cent (18%) of that portion of Net Sales of Product in the
Territory, which, during the Calendar Year in question, is greater than seventy
five million USD (US$75,000,000).

If, in the United States, if data exclusivity remains following expiry of the
last Valid Claim in a United States patent or patent application, then the
royalty rate calculated above shall be reduced to (A +B)/2 (and the remaining
royalty payments shall be payable as a royalty on Know-How). In any country in
the Territory where, during the Royalty Term, there are no Valid Claims of
Licensor Patent Rights or data exclusivity protection for the Product for a
particular Existing Indication, the royalty rate shall be reduced to five
percent (5%) (and the

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remaining royalty payments shall be payable as a royalty on Know-How)
irrespective of the amount of Net Sales of Product.

8.7        To the extent that a New Indication is Developed and Commercialized
by or on behalf of Licensee following the Effective Date then royalties will be
payable upon the Net Sales of Product for such New Indication in accordance with
Section 8.6. For these purposes:

(a)         the time periods referred to in the definitions of 'Term' and
'Royalty Term' shall relate to the New Indication(s) and not the Existing
Indication (and related definitions, including that of 'First Commercial Sale
Date' shall be read accordingly);

(b)         the provisions of Section 8.6 shall otherwise apply mutatis mutandis
to Net Sales derived from such New Indication; and

(c)         Net Sales of the Product for such New Indication shall be included
in the calculation of the 'Commercialization Milestone Payments'.

8.8        For the avoidance of doubt, any royalties or other payments owed by
Licensor under any agreement to which Licensor or any Affiliate of Licensor is a
party, including the Exploitation Agreement, shall be the sole responsibility of
Licensor.

8.9        All royalties due to the Licensor under this Agreement shall be
calculated and payable on a Calendar Quarter basis, and shall be paid by the
Licensee to the Licensor in USD within sixty (60) days following the end of each
of 31 March, 30 June, 30 September and 31 December in each year (“60 day Period”
and “Quarter End” respectively). Within sixty (60) days of each Quarter End the
Licensee shall send to the Licensor a written report setting out (i) Product by
Product and country by country the amount of Net Sales in such country during
such quarter expressed in the local currency of that country and a breakdown of
whether these relate to the Adult Indication, Pediatric Indication or New
Indication; and (ii) the amount of the royalties due to the Licensor in relation
to such Quarter. Any sales in a country other than the U.S., for purposes of
determining the Net Sales amount shall be calculated using the average rate of
exchange of the currency of such country for the applicable calendar month, as
published in The Wall Street Journal, New York edition.

8.10      Taxes.

(a)         Licensor shall be liable for all income and other Taxes (including
interest) imposed upon any payments made by Licensee to Licensor under this
Agreement (“Agreement Payments”). If applicable Laws, rules or regulations
require the withholding of Taxes, Licensee shall make such withholding payments
and shall subtract the amount thereof from the Agreement Payments. Licensee
shall submit to Licensor appropriate proof of payment of the withheld Taxes as
well as the official receipts within a reasonable period of time. Licensee shall
provide Licensor reasonable assistance in order to allow Licensor to obtain the
benefit of any present or future treaty against double taxation which may apply
to the Agreement Payments.

(b)         Licensee shall bear and be responsible for and pay all applicable
Taxes related to:

(i)          the transfer to Licensee of the Product Registrations and the
license rights granted under this Agreement; and

(ii)        the Development and Commercialization by Licensee of the Product in
the Territory other than for the PIP.

8.11      Each Party and its Affiliates shall use all reasonable efforts to
maintain complete and accurate records in sufficient detail to permit the other
Party to confirm the accuracy of the amount to be reimbursed with respect to
Development Costs, or other amounts to be paid,

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reimbursed, credited, offset or shared hereunder incurred or generated (as
applicable) by such Party's or Affiliate's achievement of sales milestones,
royalty payments and other compensation or reimbursement payable under this
Agreement. Upon reasonable prior notice, such records shall be open during
regular business hours for a period of three (3) years from the creation of
individual records for examination at the auditing Party's expense, and not more
often than once each Calendar Year, by an independent certified public
accountant selected by the auditing Party and reasonably acceptable to the
audited Party or Affiliate for the sole purpose of verifying for the auditing
Party the accuracy of the financial statements or reports or sales milestone
notices furnished by the audited Party or Affiliate pursuant to this Agreement
or of any payments made, or required to be made, by or to the audited Party or
Affiliate to the other pursuant to this Agreement. Any such auditor shall not
disclose the audited Party's or Affiliate's confidential information to the
auditing Party, but shall, instead, report that there was or was not a
discrepancy uncovered by the audit and if such a discrepancy was uncovered, the
amount and direction of it. Any amounts shown to be owed but unpaid, or overpaid
and in need of reimbursement, shall be paid or refunded (as the case may be)
within thirty (30) days after the accountant's report, plus interest (as set
forth in Section 8.13) from the original due date (unless challenged in good
faith by the audited Party, in which case any undisputed portion shall be paid
in accordance with the foregoing timetable, any dispute with respect to such
challenge shall be resolved in accordance with Section 16, any remaining
disputed portion shall be paid within thirty (30) days after resolution of the
dispute, and interest shall accrue (as set forth in Section 8.13) with respect
to the disputed portion from the original due date). The auditing Party shall
bear the full cost of such audit unless such audit reveals an overpayment to, or
an underpayment by, the audited Party or Affiliate that resulted from a
discrepancy in a report that the audited Party or Affiliate provided to the
other Party during the applicable audit period, which underpayment or
overpayment was more than ten percent (10%) of the amount set forth in such
report, in which case the audited Party or Affiliate shall bear the full cost of
such audit. Each Party, at the request of the other Party, shall make available
to the other Party the results of any audit performed by the non-requesting
Party on such non-requesting Party's Sub-licensees hereunder.

8.12      All payments made to either Party under this Agreement shall be made
by wire transfer to the account of such Party.

8.13      If a Party fails to make any payment due to the other Party hereunder
on the due date for payment and the payment is not in dispute between the
Parties, without prejudice to the other right or remedy available to the other
Party, the Party owed such Payment shall be entitled to charge the Licensee
interest (both before and after judgment) on the amount unpaid at the annual
rate of LIBOR plus two per cent (2%) calculated on a daily basis until payment
in full is made without prejudice to the Licensor's right to receive payment on
the due date.

9.          Trademarks

9.1        The Licensee shall have the option to use the Licensor Trademark in
relation to the Commercialization of Product in the Territory. The use by the
Licensee of the Licensor Trademark shall not constitute or imply any assignment
or transfer of the Licensor Trademark or any goodwill associated with it. Any
goodwill accrued in connection with the use of the Licensor Trademark shall
accrue solely to the benefit of the Licensor. The Licensee shall ensure that
each reference to and use of the Licensor Trade Mark by the Licensee in
Promotional Materials is acceptable to the Licensor and is accompanied by an
acknowledgement that the Licensor Trade Mark is owned by the Licensor and used
by the Licensee under license.

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9.2        The Licensee shall not challenge the validity of the Licensor
Trademark and shall not aid or assist third parties to do so. Whatever use the
Licensee makes of the Licensor Trademark shall inure to the sole and exclusive
benefit of the Product in accordance with this Agreement.

9.3        Except as required by applicable Law, neither Party shall use the
other Party's corporate name, or use any Trademarks of the other Party (other
than the Licensor Trademark) in connection with any Promotional Materials or
publication without the other Party's prior written consent which shall not be
unreasonably withheld. The above restriction will not apply to representations
that the Licensee is the exclusive licensee of the Licensor for the Product in
the Territory.

9.4        In the case of infringement or misuse of the Licensor Trademark, if
the Licensor fails to initiate proceedings within three (3) months of the
Licensee's notification thereof, the Licensee may give the Licensor notice
requesting the Licensor to take such proceedings within thirty (30) days of the
date of this second notice. If the Licensor fails to initiate such proceedings
within such period, the Licensee shall be entitled to do so at its own cost and
expense in which case it shall have sole conduct of any claim or proceedings.
The Licensor shall, and shall procure that its Affiliates shall, reasonably
assist and cooperate with the Licensee in any such claim, provided that the
Licensee shall reimburse the Licensor for all reasonable out-of-pocket costs and
expenses, if any, relating to such assistance and cooperation. Such reasonable
assistance and cooperation of the Licensor and its Affiliates shall include but
not be limited to the execution of such documents and the performance of such
other acts, including being joined as a party to any proceedings, as may be
reasonably required to facilitate such claim, including but not limited to such
documents and acts that may, upon the Licensee's request, be required for the
registration of the Licensee as exclusive licensee of the Licensor Trademark in
the Territory at the trademark office in the relevant countries of the
Territory. The Licensee shall have sole right to settle such proceedings
provided such settlement does not directly or indirectly adversely affect the
Licensor's rights and interests outside of the Territory, and shall be entitled
to retain any financial payment awarded in such proceedings or agreed in any
such settlement for its own account.

10.        Intellectual Property (except Trademarks)

10.1      For the purposes of this Section 10, the “Licensor IPR Package” shall
exclude the Licensor Trademark and the “Licensee IPR Package” shall exclude
Trademarks.

10.2      Except as expressly set forth in this Agreement, nothing in this
Agreement transfers ownership of the Licensor IPR Package to the Licensee.

10.3      The Licensee shall own all the Licensee IPR Package. The Licensee
shall use Commercially Reasonable Efforts to procure that, under the terms of
any appointment of a Sub-licensee, all Materials, Know How and Commercial
Information generated or developed by or upon their behalf shall be Controlled
by the Licensee.

10.4      The Licensee grants to the Licensor a perpetual, exclusive,
sub-licensable, fully paid-up royalty free right and license to use the Licensee
IPR Package outside the Territory for Development, Manufacture and
Commercialization of the Product outside the Territory other than for a New
Indication, which license rights are covered solely by the license set forth in
Section 5.9.

10.5      The Licensor shall be solely responsible at its own cost and expense
for the filing, prosecution, maintenance and/or defense of the Licensor Patent
Rights in the Territory using reasonable efforts to prosecute all patent
applications forming part of the Licensor Patent Rights to grant in the USA,
including conducting any necessary or desirable claims or proceedings (including
but not limited to any interference, reissue or re-examination or opposition or
revocation proceedings). The Licensor shall keep the Licensee reasonably

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informed of all filings made for the Licensor Patent Rights in the Territory
including sending the Licensee a copy of any such filing and otherwise shall
keep the Licensee informed of all material developments in relation to such
Licensor Patent Rights and shall, upon the Licensee's request, provide the
Licensee with copies of relevant Documents related to the filing, prosecution
and maintenance of such Licensor Patent Rights. The Licensor shall give full
consideration of, and absent a compelling reason to the contrary shall adopt any
reasonable representation made by the Licensee in relation to the prosecution of
the Licensor Patent Rights in the Territory when making any submission to a
patent office (including the scope of foreign filings) and in the conduct of any
proceedings in relation to such Licensor Patent Rights.

10.6      In the event that the Licensor declines to file or, having filed,
declines to further prosecute, maintain and/or defend any pending Licensor
Patent Rights in any country of the Territory, the Licensor shall provide the
Licensee with written notice thereof. In the case where the Licensor has filed
but is declining to further prosecute or maintain the Licensor Patent Rights,
such notice shall be given at least thirty (30) days prior to the expiration of
any official substantive deadline relating to such activities. In any of such
circumstances the Licensee shall have the right to decide that the Licensee
should file, continue to file, prosecute and maintain such Licensor Patent
Rights and in such case the Licensee shall give written notice to the Licensor.
The Licensor shall upon receipt of any such notice from the Licensee transfer to
the Licensor all its files relating to the relevant Licensor Patent Rights and
at the Licensee's cost and expense execute any documents to otherwise transfer
control of such filing, prosecution and maintenance to the Licensor and
thereafter the Licensee shall be responsible for the cost and expense of
prosecuting and maintaining such Licensor Patent Rights. In addition the
Licensor shall assign such Licensor Patent Rights to the Licensee for zero or
nominal consideration, whereupon they shall not be part of any license rights
granted to or through Licensor hereunder.

10.7      The Licensee shall be responsible at its own cost and expense and in
its sole discretion for the filing, prosecution, maintenance and/or defense of
Patent Rights in respect of inventions within Know How developed by the
Licensee, its Affiliates or Sub-licensees relating to or potentially covering
Product (the “Licensee Patents Rights”). The Licensee shall keep the Licensor
informed of all material developments in relation to the Licensee Patent Rights
and shall, upon the Licensor's request, provide the Licensor with copies of
relevant documents related to the filing, prosecution and maintenance of the
Licensee Patent Rights. The Licensee shall consider in good faith any reasonable
representation made by the Licensor in relation to the prosecution of Patent
Rights within the Licensee Patent Rights when making any submission to a patent
office and in the conduct of any proceedings in relation to such Licensee Patent
Rights in Europe.

10.8      In the event that the Licensee declines to file or, having filed,
declines to further prosecute, maintain and/or defend any pending Licensee
Patent Rights in any country of the Territory or Europe, the Licensee shall
provide the Licensor with written notice thereof. In the case where the Licensee
has filed but is declining to further prosecute or maintain such Licensee Patent
Rights, such notice shall be given at least thirty (30) days prior to the
expiration of any official substantive deadline relating to such activities. In
any of such circumstances the Licensor shall have the right to decide that the
Licensor should file, continue to file or prosecute such Licensee Patent Rights
and in such case the Licensor shall give written notice to the Licensee. The
Licensee shall upon receipt of any such notice from the Licensor transfer to the
Licensor all its files relating to such Licensee Patent Rights and execute any
documents necessary to transfer control of such filing, prosecution and
maintenance to the Licensor. In addition the Licensee shall assign such Licensee
Patent Rights to the Licensor for zero or nominal consideration, whereupon they
shall not be part of any license rights granted to or through Licensee
hereunder.

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10.9      If either Party becomes aware of any actual, threatened or suspected
infringement or misuse by a Third Party of any of the Licensor IPR Package
relating to the Product in the Territory, it shall promptly inform the other
Party in writing of all available evidence and details available to it
concerning said infringement (the “Infringement Notice”). With respect to any
actual, threatened or suspected infringement, the Licensee shall have the right,
but not an obligation, at its own cost and expense to bring, defend or maintain
any suit or action, in which case it shall have sole conduct of any claim or
proceedings including any counterclaim for invalidity or unenforceability or any
declaratory judgment action. The Licensor shall provide all necessary assistance
to the Licensee in relation to such proceedings (including being joined as a
party to any such proceedings) and the Licensee shall on demand by the Licensor
indemnify the Licensor against reasonable costs of such activity that were
approved by Licensee in advance in writing, provided that if the Licensor elects
to be separately represented (which shall be at the Licensor's discretion), such
separate representation shall be at the Licensor's sole cost and expense. The
Licensee shall retain any award of costs and damages made or settlement sum
paid, after recovery by the Licensor of its actual out-of-pocket costs and
expenses. The Licensee will not (i) enter into any settlement of or make
admission or stipulation in any such proceedings that admits any liability of
Licensor or materially negatively impacts Licensor's rights hereunder or in the
Licensor IPR Package without the Licensor's prior written consent, not to be
unreasonably withheld or delayed.

10.10    If under Section 10.9, the Licensee fails to take any such proceedings
within 90 days of any Infringement Notice, then the Licensor shall have the
right, but not the obligation, upon 20 days prior notice to the Licensee at the
Licensor's expense to bring, defend or maintain any suit or action or to control
the conduct thereof against any actual, threatened or suspected infringement.
The Licensee shall provide all necessary assistance to the Licensor in relation
to such proceedings (including being joined as a party to any such proceedings).
In any such action brought by the Licensor, the Licensor shall retain any award
of costs and damages made or settlement sum paid, after recovery by the Licensee
of its actual out-of-pocket costs and expenses. The Licensor will not enter into
any settlement of or make admission or stipulation in any such proceedings that
admits any liability of Licensee or materially negatively impacts Licensee's
rights hereunder or in the Licensor IPR Package without the Licensee's prior
written consent, not to be unreasonably withheld or delayed.

10.11    If either Party or its Affiliates receives formal notice from a Third
Party that the Development, Manufacture or Commercialization of Product in the
Territory under this Agreement infringes or otherwise violates the intellectual
property rights of such Third Party in the Territory, then such Party must
promptly notify the other Party in writing of this allegation. As soon as
reasonably practicable after the receipt of such notice and at all times
thereafter, the Parties will meet and consider the appropriate course of action
with respect to such allegation of infringement. In any such instance, each
Party will at its own cost, expense and liability, have the right to defend any
action naming it; however, the Parties will at all times cooperate, share all
material notices and filings in a timely manner, provide all reasonable
assistance to each other and use good faith efforts mutually to agree upon an
appropriate course of action, including, as appropriate, the preparation of
material court filings and any discussions concerning a potential defense and/or
settlement of any such claim. The rights and obligations in this Section 10.11
will apply even if only one Party defends any such claimed infringement action
commenced by a Third Party. Neither Party will enter into any settlement of or
make admission or stipulation in any such proceedings that admits any liability
of the other Party or materially negatively impacts such other Party's rights
hereunder or in the Licensor IPR Package without such other Party's prior
written consent, not to be unreasonably withheld or delayed.

10.12    The Parties agree to cooperate in an effort to avoid loss of any of the
Patent Rights forming part of the Licensor IPR Package or Licensee IPR Package
including by executing any

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documents as may be reasonably required. In particular, the Parties shall
cooperate with each other in obtaining patent term extension or restoration or
supplemental protection certificate (“Patent Term Extensions”) or their
equivalents in any country of the Territory. Licensee shall have the sole right
and shall use Commercially Reasonable Efforts to seek any available Patent Term
Extensions in the Territory.

11.        Confidentiality

11.1      Except to the extent expressly authorized by this Agreement or
otherwise agreed in writing by the Parties, each Party agrees that, during the
Term and for seven (7) years thereafter, it shall, and shall cause its
Affiliates, to keep confidential and not publish or otherwise disclose to any
Third Party, and not use for any purpose other than as provided for in this
Agreement, any Confidential Information of the other Party or any of its
Affiliates, provided that each Party and its Affiliates may disclose the
Confidential Information of the other Party or its Affiliates to the receiving
Party's and its Affiliates' officers, directors, employees, agents and advisors
who in each case are bound by commercially reasonable obligations of
confidentiality with respect to the use and disclosure of such Confidential
Information. Notwithstanding the foregoing, Confidential Information of a Party
or its Affiliate shall exclude that portion of such information or materials
that the receiving Party (or the receiving Party's Affiliate) can demonstrate by
competent written proof:

(a)         was generally available in the public domain at the time it was
disclosed to the receiving party or subsequently came into the public domain
through no fault of the receiving party; or

(b)         was already known to the receiving Party or its Affiliate, other
than under an obligation of confidentiality, at the time of disclosure by the
other Party or is subsequently disclosed to the receiving Party or its Affiliate
by a Third Party without obligations of confidentiality with respect thereto.

(c)         is independently discovered or developed by the receiving Party or
its Affiliate without the aid, application, or use of Confidential Information.

11.2      For clarity, specific aspects or details of Confidential Information
shall not be deemed to be within the public domain or in the possession of the
Recipient Party merely because the Confidential Information is embraced by more
general information in the public domain or in the possession of the Recipient
Party. Further, any combination of Confidential Information shall not be
considered in the public domain or in the possession of the Recipient Party
merely because individual elements of such Confidential Information are in the
public domain or in the possession of the Recipient Party unless the combination
is in the public domain or in the possession of the Recipient Party.

11.3      Notwithstanding the above obligations of confidentiality and non-use a
Recipient Party may disclose Confidential Information:

(a)         In responding to a valid order of a court of competent jurisdiction
or other competent authority; provided that the receiving Party shall, to the
extent reasonably practicable under the circumstances, first have given to the
disclosing Party notice and a reasonable opportunity to quash the order or
obtain a protective order requiring that the Confidential Information be held in
confidence or used only for the purpose for which the order was issued; and
provided further that if such order is not quashed or a protective order is not
obtained, the Confidential Information disclosed shall be limited to the
information that is legally required to be disclosed;

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(b)         to a Regulatory Authority as reasonably necessary to obtain
Regulatory Approval in a particular jurisdiction to the extent consistent with
the licenses granted under terms of this Agreement; and

(c)         In complying with Applicable Law, provided that to the extent such
disclosure is required to comply with a Legal Requirement, including to the
extent such disclosure is required in publicly filed financial statements or
other public statements under rules governing a stock exchange; provided, to the
extent possible bearing in mind such Legal Requirements and subject to the next
subsequent sentence of this Section (c), such Party shall provide the other
Party with a copy of the proposed text of such statements or disclosure five (5)
days in advance of the date on which the disclosure is to be made to enable the
other Party to review and provide comments, unless a shorter review time is
agreed. [If the compliance with a Legal Requirement requires filing of this
Agreement, the filing Party shall to the extent possible seek confidential
treatment of portions of this Agreement from the relevant Government Authority
and shall provide the other Party with a copy of the proposed filings at least
five (5) days prior to filing for the other Party to review any such proposed
filing.]2 Each Party agrees that it will obtain its own legal advice with regard
to its compliance with Legal Requirements and will not rely on any statements
made by the other Party relating to such Legal Requirements;

(d)         (i) to its actual or potential investment bankers; (ii) to existing
and potential investors in connection with an offering or placement of
securities for purposes of obtaining financing for its business and to actual
and prospective lenders for the purpose of obtaining financing for its business;
and (iii) to a bona fide potential acquirer or merger partner for the purposes
of evaluating entering into a merger or acquisition, provided, however, any such
persons must be obligated to substantially the same extent as set forth in
Section 11 to hold in confidence and not make use of such Confidential
Information for any purpose other than those permitted by this Agreement; and

(e)         to its legal advisers for the purpose of seeking advice.

11.4      Nothing in this Section 11 restricts either Party from using or
disclosing any of its own Confidential Information for any purpose whatsoever,
subject always to the rights granted in this Agreement and provided always that
the Licensee shall not under any circumstances publish the results of any
clinical studies on Product without the prior written approval of the Licensor.

11.5      Following execution of this Agreement, each Party shall release a
separate press release regarding this transaction and the wording of each press
release shall be pre-agreed by the other Party. Other than such press releases,
save as permitted in Section 11.3 neither Party shall make any public
announcement or statement to the public containing Confidential Information
without the prior written consent of the other. No such public announcements or
statements shall be made without the prior review and consent of the appropriate
individual designated for the purpose by the other Party

Publicity

11.6      Licensor, along with trial investigators, has submitted for
publication a draft publication regarding the pivotal trial for the NDA Product.
Promptly upon Licensor’s receipt thereof, Licensor agrees to provide a copy to
Licensee a of all correspondence and editorial feedback regarding such
publication for Licensee's review and comment, which comments Licensor

 

 

 

 

 

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2         Note to draft: Parties to discuss whether or not the agreement will be
afforded confidential treatment.

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shall accept and incorporate into such publication prior to any resubmission or
finalization thereof.

11.7      Subject to Section 7.6, other than with respect to the publication
regarding the pivotal trial, the Parties shall each provide the other Party with
copies of any publications or meeting abstracts relating to a Product for such
other Party's review and comment at least thirty (30) days prior to submitting
such publication to any journal or submitting or presenting it or an abstract
thereof at any congress, conference or other public meeting, and each Party
agrees to take reasonably into account any comments received from the other
Party thereon.

11.8      Following final submission of the publication for the pivotal trial,
(a) Licensor and its Affiliates and Sub-licensees shall refrain from engaging
any study investigator, practitioners, opinion leaders, patient advocates and
payers in the Territory regarding the Product for any reason, including
scientific discourse, without the prior consent of Licensee (such consent not to
be unreasonably withheld, delayed or conditioned); and (b) Licensee and its
Affiliates and Sub-licensees shall refrain from engaging any study investigator,
practitioners, opinion leaders, patient advocates and payers outside the
Territory regarding the Product for any reason, including scientific discourse,
without the prior consent of the Licensor (such consent not to be unreasonably
withheld, delayed or conditioned).

12.        Representations, warranties and covenants

12.1      Mutual Representations and Warranties. Each Party hereby represents,
warrants, and covenants (as applicable) to the other Party as of the Effective
Date as follows:

(a)         Corporate Existence and Power. It is a company or corporation duly
organized, validly existing, and in good standing under the Laws of the
jurisdiction in which it is incorporated, and has full corporate power and
authority and the legal right to own and operate its property and assets and to
carry on its business as it is now being conducted and as contemplated in this
Agreement, including the right to grant or receive, as the case may be, the
licenses granted and received hereunder.

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

(c)         No Conflict. It is not a party to and will not enter into any
agreement that would prevent it from granting the rights or exclusivity granted
or intended to be granted to the other Party under this Agreement or performing
its obligations under this Agreement.

(d)         No Debarment. Such Party is not debarred, has not been convicted,
and is not subject to debarment or conviction pursuant to Section 306 of the
Federal Food, Drug and Cosmetics Act. To such Party's Knowledge, in the course
of the Development of the API or Products, such Party has not used prior to the
Effective Date and shall not use, during the Term, any employee, agent or
independent contractor who has been debarred by any Regulatory Authority, or, to
the best of such Party's Knowledge, is the subject of debarment proceedings by a
Regulatory Authority or has been convicted pursuant to Section 306 of the FD&C
Act.

(e)         Anti-Corruption. Such Party, its Affiliates and their respective
directors, officers, employees, agents or other persons or entities acting on
its behalf (all the foregoing collectively “Representatives”) have conducted and
will conduct their businesses as

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they relate to this Agreement, in compliance with Anti-Bribery Laws. Without
limiting the generality of the foregoing, such Party represents and warrants
that it has and will have necessary procedures in place to prevent bribery and
corrupt conduct by it and its Representatives in connection with the
Development, Manufacture and Commercialization of the Product.

12.2      Representations, Warranties and Covenants by Licensor. Licensor hereby
represents, warrants and covenants to Licensee, as of the Effective Date, as
follows, except as set forth otherwise in the Disclosure Schedule:

(a)         Licensor owns or has a valid right to grant the licenses hereunder
to the Licensor IPR Package existing as of the Effective Date, including the NDA
and Licensor Patent Rights, and Licensor has the right to make the assignments
and grant the licenses to Licensee as purported to be granted pursuant to this
Agreement. Neither Licensor nor any of its Affiliates has entered into any
agreement granting any right, interest or claim in or to, any Licensor Patent
Rights or Licensor Know-How to any Third Party (other than pursuant to the CMO
Contracts included in the Data Room) that would conflict with the licenses to
Licensee as purported to be granted pursuant to this Agreement.

(b)         All Licensor Patent Rights are listed in Schedule 7. All Licensor
Patent Rights are subsisting and are not invalid or unenforceable, in whole or
in part, are being prosecuted in the patent offices indicated in Schedule 7 in
accordance with Applicable Law, and all applicable fees have been paid on or
before the Effective Date. The Licensor Patent Rights represent all Patent
Rights within Licensor' or its Affiliates' ownership or Control that Licensor
reasonably believes include claims covering the making, using, and composition
of matter of the API or the Products, or the Development, Manufacture or
Commercialization thereof, as of the Effective Date. Licensor has properly
recorded in the relevant U.S. and Canadian patent offices the assignments, or
other necessary documents, supporting its legal title to the Licensor Patent
Rights. To the Licensor’ Knowledge, Licensor and its Affiliates have presented,
or will present prior to the pertinent patent office deadlines, all relevant
references, documents, or information of which it and the inventors are aware to
the relevant patent examiner at the pertinent patent office, in connection with
the prosecution of the pending patent applications included in the Licensor
Patent Rights.

(c)         There are no claims, judgments, or settlements against, or amounts
with respect thereto, owed by Licensor or any of its Affiliates relating to the
Product Registrations, the Licensor Patent Rights, or the Licensor Know-How. No
claim or litigation has been brought or threatened in writing by any Person
against Licensor alleging, and Licensor has no Knowledge of any reasonable basis
for any such claim or allegation, whether or not asserted, that (i) the Licensor
Patent Rights or the Licensor Know-How are invalid or unenforceable, or (ii) the
Product Registrations, the Licensor Patent Rights, or the Licensor Know-How, or
the disclosing, copying, making, assigning, or licensing of the Product
Registrations, the Licensor Patent Rights, or the Licensor Know-How, or the
Development, Manufacture, Commercialization or other exploitation of the API or
Products as contemplated herein, does or will violate, infringe, misappropriate
or otherwise conflict or interfere with, any Patent or other intellectual
property or proprietary right of any Third Party.

(d)         To Licensor's Knowledge, no Person is infringing or threatening to
infringe or misappropriating or threatening to misappropriate the Licensor
Patent Rights, the Licensor Know-How, or the Product Registrations. To Licensor’
Knowledge, there are no activities by Third Parties that would constitute
infringement or misappropriation of the Licensor Technology (in the case of
pending claims, evaluating them as if issued).

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(e)         Each Person who, to Licensor’s Knowledge, has or has had any rights
in or to any Licensor Patent Rights or any Licensor Know-How, has assigned and
has executed an agreement assigning its entire right, title, and interest in and
to such Licensor Patent Rights and Licensor Know-How to Licensor. To Licensor's
Knowledge, no current officer, employee, agent, or consultant of Licensor or any
of its Affiliates is in violation of any term of any assignment or other
agreement regarding the protection of Patents or other intellectual property or
proprietary information of Licensor or such Affiliate or of any employment
contract relating to the relationship of any such Person with Licensor.

(f)         None of the intellectual property rights licensed hereunder by
Licensor to Licensee and existing as of the Effective Date are owned or
Controlled in whole or in part by any Third Party other than the rights under
the CMO Contracts included in the Data Room.

(g)         With respect to those portions of the Licensor Know-How the
confidentiality of which is material to the Commercialization of Products, such
portions of the Licensor Know-How have been kept confidential or have been
disclosed to Third Parties only under terms of confidentiality. To Licensor'
Knowledge, no breach of such confidentiality has been committed by any Third
Party.

(h)         There are no pending, and to Licensor's Knowledge there are no
threatened, actions, claims, demands, suits, proceedings, arbitrations,
grievances, citations, summonses, subpoenas, inquiries or investigations of any
nature, civil, criminal, regulatory or otherwise, in law or in equity, against
Licensor or any of its Affiliates or, to the Knowledge of Licensor, pending or
threatened against any Third Party, in each case, relating to the transactions
contemplated by this Agreement.

(i)          Other than the Exploitation Agreement, Licensor has not entered
into any agreement with a Third Party pursuant to which Licensor may be
obligated to pay a royalty or other consideration with respect to sales of a
Product, nor is there any agreement that the Licensor is a party to which
conflicts with or restricts in any material manner, the rights assigned or
licensed by Licensor to Licensee hereunder.

(j)          Licensor is not, and to Licensor's Knowledge no other party to such
agreement is, in breach of any obligations owed under the Exploitation
Agreement.

(k)         Licensor has provided or made available to Licensee, prior to the
Effective Date, true, complete, and correct copies of all material adverse
information with respect to the safety and efficacy of the API and Product which
is known to Licensor.

(l)          To Licensor's Knowledge, Licensor and its Affiliates and licensees
have generated, prepared, maintained, and retained all Product Registrations
that are required to be maintained or retained pursuant to and in accordance
with applicable Law, and all such information is true, complete and correct and
what it purports to be.

(m)        Licensor and its Affiliates have conducted, and to Licensor's
Knowledge, their respective contractors licensees and consultants have
conducted, all Development of the API or the Products that they have conducted
prior to the Effective Date in accordance with applicable Law. To Licensor’s
Knowledge, Licensor has conducted, and has caused its licensees, contractors and
consultants to conduct, any and all pre-clinical and clinical studies related to
the API and Products in accordance with Applicable Law. To Licensor's Knowledge,
Licensor and its Affiliates and licensees have employed (and, with respect to
such tests and studies that Licensor will perform, will employ) Persons with
appropriate education, knowledge and experience to conduct and to oversee the
conduct of the PIP.

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(n)         To Licensor's Knowledge, neither Licensor nor any of its Affiliates
or licensees, nor any of its or their respective officers, employees, or agents
has made an untrue statement of material fact or fraudulent statement to the FDA
or any other Regulatory Authority with respect to the Development of the API or
the Products, failed to disclose a material fact required to be disclosed to the
FDA or any other Regulatory Authority with respect to the Development of the API
or the Products, or committed an act, made a statement, or failed to make a
statement with respect to the Development of the API or the Products that could
reasonably be expected to provide a basis for the FDA to invoke its policy
respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal
Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any
amendments thereto or any analogous Laws or policies in the Territory.

(o)         The inventions claimed in the Licensor Patent Rights (i) were not
conceived or made in connection with any research activities funded, in whole or
in part, by the federal government of the United States or any agency thereof,
(ii) are not a “subject invention” as that term is described in 35 U.S.C.
Section 201(f), and (iii) are not otherwise subject to the provisions of the
Bayh-Dole Act.

12.3      Each Party undertakes to inform the other as soon as it becomes aware
that any of the following events are reasonably likely to occur:

(a)         cessation of conducting its business or trading;

(b)         sale of all or any material portion of its assets or business;

(c)         entry of a judgment against such Party in an amount that exceeds
US$100,000 or the entry of any declaratory, injunctive or other equitable remedy
or court order that would materially impair such Party's ability to continue to
conduct its business or to perform its obligations under this Agreement;

(d)         any attachment (including prejudgment attachment) of any material
assets;

(e)         failure to pay any wages to such Party's employees when due (except
to the extent subject to a bona fide dispute);

(f)         a financial institution which lends money to such Party declaring an
event of default by the company under any bank loan or other debt instrument;

(g)         entry by the Party into any restructuring or workout agreement, or
similar agreement, relating to any material indebtedness (being debt exceeding
US$100,000); or

(h)         loss of any permits, licenses or governmental authorizations that
are reasonably necessary in order for the Party to continue to engage in its
current business.

12.4      Except as expressly set forth herein, each Party expressly disclaims
and excludes any and all representations and warranties, express, implied,
statutory or otherwise, including without limitation the warranties of
merchantability and fitness for a particular purpose.

12.5      EXCEPT WITH RESPECT TO (1) AMOUNTS OWED TO A THIRD PARTY WHICH AMOUNTS
FALL WITHIN THE INDEMNIFICATION OBLIGATIONS OF A PARTY UNDER SECTIONS 13.1 AND
13.2, (2) DAMAGES AVAILABLE FOR A PARTY'S BREACH OF ITS CONFIDENTIALITY
OBLIGATIONS HEREUNDER, OR (3) DAMAGES AVAILABLE IN THE CASE OF A PARTY'S FRAUD,
GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES
ARISING FROM OR RELATING TO ANY

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BREACH OF THIS AGREEMENT OR ANY TORT CLAIMS ARISING HEREUNDER, REGARDLESS OF ANY
NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

12.6      Nothing in this Agreement shall be taken to exclude or limit either
Party's liability to the extent that such liability cannot be excluded or
limited in Law, including for death or personal injury, fraud or fraudulent
misrepresentation.

12.7      The Parties agree that:

(a)         Licensor shall use all reasonable efforts to negotiate and execute,
as soon as reasonably practicable after the Effective Date, an amendment to the
Exploitation Agreement which provides that upon the termination of the
Exploitation Agreement The Centre National De La Recherche Scientifique will be
obligated to enter into an agreement with the Licensee, in respect of the
Territory, on substantially the same terms as those provided to the Licensor
under the Exploitation Agreement including in respect of royalty payments; and

(b)         the Licensee shall use all reasonable efforts to assist the Licensor
in respect of its obligation at Section 12.7(a) above,

and it is agreed that the Licensor shall not be obligated pursuant to this
Section 12.7 to agree to any increase in the royalties payable under the
Exploitation Agreement.

13.        Indemnity and insurance cover

13.1      Indemnification by Licensee. Subject to Sections 13.3 and 13.4,
Licensee shall indemnify, defend and hold Licensor, its Affiliates, and their
respective directors, officers, employees consultants, contractors,
sub-licensees and agents (collectively, the “Licensor Indemnitees”) harmless
from and against any and all claims, suits, proceedings or causes of action
(“Claims”) brought against such Licensor Indemnitee, including any damages or
other amounts payable with respect to such Claims, as well as any reasonable
attorneys' fees and costs of litigation incurred as to any such Claim until the
indemnifying Party has acknowledged that it will provide indemnification
hereunder with respect to such Claim as provided below (collectively,
“Damages”), in each case to the extent resulting from or based on:

(a)         any development work done by Licensee for a Product, or any sale,
use, importation, storage, handling, distribution or offer for sale or sale of
Product by Licensee or any of its Affiliates or sub-licensees;

(b)         Licensee's breach of this Agreement or any representation or
warranty made by Licensee herein;

(c)         the willful misconduct of, or violation of applicable Law by,
Licensee, its Affiliates or Sub-licensees, or their respective employees,
contractors or agents in the performance of this Agreement; and/or (d) breach of
a contractual or fiduciary obligation owed by Licensee (including without
limitation misappropriation of trade secrets).

(d)         infringement or misappropriation with respect to the Development,
Manufacture, or Commercialization of the Product in the Territory under the
Licensee IPR Package or Licensee Trademarks.

and the foregoing indemnity obligation shall not apply to the extent such Claims
or Damages result from any matter for which Licensor is required to indemnify
Licensee.

13.2      Indemnification by Licensor. Subject to Sections 13.3 and 13.4,
Licensor shall indemnify, defend and hold Licensee, its Affiliates, and their
respective directors, officers, employees

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consultants, contractors, sub-licensees and agents (collectively, the “Licensee
Indemnitees”) harmless from and against any and all Third Party Claims brought
against such Licensee Indemnitee, including any Damages resulting therefrom, in
each case to the extent resulting from or based on:

(a)         any development work done by Licensor for a Product, or any sale,
use, importation, storage, handling, distribution or offer for sale or sale of
Product by Licensor or any of its Affiliates or sub-licensees;

(b)         Licensor's breach of this Agreement or any representation or
warranty made by Licensor therein;

(c)         the willful misconduct of, or violation of applicable Law by,
Licensor, its Affiliates or sub-licensees, or their respective employees,
contractors or agents in the performance of this Agreement;

(d)         breach of a contractual or fiduciary obligation owed by Licensor
(including without limitation misappropriation of trade secrets); or

(e)         infringement or misappropriation with respect to the Development,
Manufacture, or Commercialization of the NDA Product under the Licensor IPR
Package or Licensor Trademarks.

and the foregoing indemnity obligation shall not apply to any Damages to the
extent such Damages result from any matter for which Licensee is required to
indemnify Licensor pursuant to Section 13.1(b), (c), or (d).

13.3      Indemnification of Product Liability Claims. Notwithstanding any other
provision of this Agreement, this Section 13.3 shall govern the allocation of
liability with respect to claims of property injury, bodily injury or death
related to Product in the Territory.

(a)         Subject to Section 13.4, Licensor shall indemnify and hold the
Licensee Indemnitees harmless from and against any and all Damages which a
Licensee Indemnitee may incur or suffer arising out of any Third Party claim of
property damage, bodily injury or death (including negligence, tort, strict
liability or otherwise) to the extent caused by (i) any Licensor Design Defect
or (ii) any sale, use, importation, storage, handling, distribution, offer for
sale or sale of Product, or development of a Product conducted by Licensor. A
“Licensor Design Defect” shall be a defect in the design or formulation of the
NDA Product as such NDA Product is designed and formulated as set forth in the
NDA on the Effective Date.

(b)         Subject to Section 13.4 and except to the extent provided in
subsection (a) above, Licensee shall defend, indemnify and hold the Licensor
Indemnitees harmless from and against any and all Damages arising out of any
Third Party claims of property damage, bodily injury or death (including
negligence, tort, strict liability or otherwise) to the extent caused by (i) any
sale, use, importation, storage, handling, distribution, offer for sale or sale
of Product, or development of such Product conducted by, Licensee; or (ii) any
Licensee Design Defect. A “Licensee Design Defect” shall be a defect in the
design or formulation of the Product designed or formulated by Licensee that
differs from the design or formulation of the NDA Product as of the Effective
Date.

13.4      Indemnification Procedures. A Party seeking indemnification under
Section 13.1,  13.2 or 13.3 hereof (the “Indemnitee”) shall promptly notify the
other Party (the “Indemnitor”) in writing of any claim, lawsuit or other action
in respect of which the Indemnitee, its Affiliates, or any of their respective
directors, officers, employees and agents intend to claim such

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indemnification. The Indemnitee shall permit, and shall cause its Affiliates and
their respective directors, officers, employees and agents to permit the
Indemnitor to have complete control of such defense (except as set forth below)
so long as it promptly assumes the defense and prosecutes the defense with
appropriate diligence and care. Notwithstanding the foregoing, such Indemnitor
shall not have the right to defend or direct the defense of any such claim,
lawsuit or other action that (x) is asserted directly by or on behalf of a Third
Party that is a supplier or direct customer of the Indemnitee, or (y) seeks an
injunction or other equitable relief against the Indemnitee. The Party
controlling the defense hereunder (the “Defending Party”) shall have the
authority, at its discretion, to settle any such claim, lawsuit or other action
only with the prior written consent of the Party who is not controlling the
defense (the “Non-Defending Party”), provided, however, that such consent shall
not be unreasonably withheld or delayed so long as such settlement does not
adversely affect the Non-Defending Party's rights hereunder or impose any
obligations on the Non-Defending Party in addition to those set forth herein.
The Defending Party and the Non-Defending Party, and their respective
Affiliates, and their respective directors, officers, employees and agents shall
cooperate fully with each other and their respective legal representatives in
the investigation and defense of any claim, lawsuit or other action covered by
this indemnification. The Defending Party shall keep the Non-Defending Party
reasonably informed of the progress of the action and shall consider the
comments and observations of the Non-Defending Party timely given in the course
of the proceedings. If the Indemnitor is the Defending Party, the Indemnitee
shall have the right, but not the obligation, to be represented by counsel of
its own selection and expense. Notwithstanding the foregoing, the Indemnitee may
be represented by separate counsel at the expense of the Indemnitor if a
conflict of interest exists between the interests of the Indemnitor and
Indemnitee so that a single counsel representing Indemnitor cannot adequately
defend the rights of the Indemnitee.

13.5      Survival of Indemnification Obligations. The provisions of Sections
12.7 shall survive the termination or expiration of this Agreement.

13.6      Each Party shall maintain, at its own cost, the insurance coverages
set forth in this Section 13.6; provided, however, the Licensee has the right,
in its sole discretion, to self-insure in part or in whole for any such
coverages:

(a)         commencing as of the Effective Date, and thereafter for the period
of time required under Section 13.7, each Party shall obtain and maintain on an
ongoing basis, commercial general liability insurance, including contractual
liability, in the minimum amount of ten million dollars ($10,000,000) per
occurrence, combined single limit for bodily injury and property damage
liability, and

(b)         commencing as of the Effective Date, and thereafter for the period
of time required under Section 13.7, each Party shall obtain and maintain on an
ongoing basis, products liability insurance, including contractual liability, in
the minimum amount of ten million dollars ($10,000,000) per occurrence, combined
single limit for bodily injury and property damage liability.

13.7      Except to the extent that the Licensee self-insures as authorized
under Section 13.6, the following provisions apply:

(a)         All insurance coverages shall be primary insurance with respect to
each Party's own participation under this Agreement, and shall be maintained
with an insurance for the Licensee or companies having an A.M. Best's rating (or
its equivalent) of A-XII or better.

(b)         Each Party shall be provided additional insured status under the
other party’s commercial general liability and products liability insurance
policies.

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(c)         The insurance policies shall be under an occurrence form, but if
only a claims-made form is available to a Party, then in such a case, such Party
shall maintain the insurance coverage for at least five (5) years following such
Party's completing performance of its obligations under this Agreement.

(d)         Each Party's aggregate deductibles under its commercial general
liability and products liability and other insurance policies shall be
reasonably satisfactory to the other Party, taking into account the deductibles
that are prudent and customary with respect to the activities in which it is
engaged under this Agreement.

(e)         Each Party's insurance coverage shall include an option to purchase
tail coverage for claims arising during a period covered by such insurance (the
policy period) but for which claims are not brought during the policy period,
which tail period shall have a duration of at least five (5) years following the
end of the policy period. The tail coverage will be purchased if the insurance
coverage in place is cancelled or non-renewed.

(f)         Each Party shall provide to the other Party its respective
certificates of insurance evidencing the insurance coverages set forth in
Section 13.6 Each Party shall provide to the other Party at least thirty (30)
days prior written notice of any cancellation, non-renewal or material change in
any of the insurance coverages. Each Party shall, upon receipt of written
request from the other Party, provide renewal certificates to the other Party
for as long as such Party is required to maintain insurance coverages hereunder.

14.        Duration and termination of the agreement

14.1      The Agreement shall enter into force and effect on the Effective Date
and shall remain in full force and effect country by country of the Territory
for the duration of the Term, subject to earlier termination as provided in this
Agreement. At the expiry of the Royalty Term in each country of the Territory
the licenses granted by the Parties hereunder shall become perpetual,
irrevocable, fully paid up and royalty free in such country.

14.2      The Licensee shall be entitled to terminate the Agreement:

(a)         effective immediately upon prior written notice to the Licensor
pursuant to Section 7.11(d), if the Licensee can demonstrate that there are
reasonable good faith grounds to believe there is a safety concern related to
the Product, or

(b)         effective immediately upon prior written notice to the Licensor in
case of withdrawal of the Regulatory Approval for the Product in the United
States for whatever reason which the Licensee reasonably believes will be
permanent;

(c)         effective upon two hundred and seventy (270) days' prior written
notice to the Licensor, for any reason or no reason; or

(d)         pursuant to Section 14.4 below, which relates to a material breach
of the Agreement by the Licensor.

14.3      The Licensor shall be entitled to terminate this Agreement pursuant to
Section 14.4 below, which relates to a material breach of the Agreement by the
Licensee.

14.4      Either Party (the non-breaching Party) shall have the right to
terminate this Agreement upon giving ninety (90) days written notice to the
other Party on the occurrence of a material breach by such other Party (the
breaching Party) which material breach is incapable of remedy or which, in the
case of a breach capable of remedy, shall not have been remedied

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within such ninety (90) day notice period, provided that the non-breaching Party
shall have identified in its notice the breach in reasonable detail. If the
breach relates to:

(a)         Canada then the Licensor shall only have the right to terminate this
Agreement in relation Canada; or

(b)         the USA then the Licensor shall have the right to terminate this
Agreement in its entirety.

If the breaching Party in good faith disputes such material breach or disputes
the failure to cure or remedy such material breach and provides written notice
of that dispute to the non-breaching Party within the above notice period, then
the matter will be addressed under the dispute resolution provisions in
Section 16 and the non-breaching Party may not terminate this Agreement until it
has been determined under Section 16 that the breaching Party is in material
breach of this Agreement, and the breaching Party further fails to cure such
breach within sixty (60) days after the conclusion of that dispute resolution
procedure.

14.5      Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by either Party are, and shall otherwise be deemed to
be, for purposes of section 365(n) of the U.S. Bankruptcy Code, licenses of
right to “intellectual property” as defined under Section 101 of the U.S.
Bankruptcy Code. The Parties agree that each Party, as licensee of certain
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code. The Parties further agree
that, in the event of the occurrence of a Bankruptcy Event in respect of a Party
(such Party, the “Debtor”) under the U.S. Bankruptcy Code, the other Party shall
be entitled to a complete duplicate of (or complete access to, as appropriate)
any intellectual property licensed to such other Party and all embodiments of
such intellectual property, which, if not already in such other Party's
possession, shall be promptly delivered to it:

(a)         upon any such commencement of a bankruptcy proceeding upon such
other Party's written request therefor, unless the Debtor elects to continue to
perform all of its obligations under this Agreement; or

(b)         if not delivered following the rejection of this Agreement by the
Debtor upon written request therefor by the other Party.

14.6      Expiration of, or termination of this Agreement by Licensee pursuant
to Section 14.4, shall result in the following:

(a)         All rights granted by the Licensor to the Licensee in the Licensor
IPR Package and Licensor Trademarks under the Agreement shall become
fully-paid-up, royalty-free and perpetual.

(b)         The rights and obligations of the Parties set forth in Section 10
shall continue until the date that is six (6) years after the last to expire
Valid claim of a Patent Right Controlled by either Party shall have expired.

(c)         The obligations with respect to monitoring and exchange of safety
information set forth in Section 7.11 shall continue for as long as both Parties
are Developing or Commercializing a Product anywhere in the World, with each
Party bearing its own costs and expenses with respect thereto.

14.7      Termination of this Agreement by Licensee other than pursuant to
Section 14.4, or by Licensor pursuant to Section 14.2(b), shall result in the
following, which, if the termination is in relation to a country, shall only
apply in such country:

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(a)         Termination of all rights granted by the Licensor to the Licensee
under the Agreement and reversion to the Licensor of such rights. The Licensee
shall immediately cease all use of the Licensor IPR Package and shall cease all
Development, manufacturing and Commercialization activity. All Sub-licenses
agreements and arrangements shall terminate simultaneously.

(b)         The Licensee hereby grants to the Licensor a non-exclusive,
perpetual, sub-licensable, fully paid-up royalty free right and license to use
the Licensee IPR Package inside such Country for the Development and
Commercialization of the Product in such country and for the Manufacture of
Products in the Territory. Termination shall have no impact upon the Licensor's
rights to use the Licensee IPR Package outside the Territory.

(c)         The Licensee shall promptly transfer to the Licensor the Licensee
Materials, Licensee Know How, Product Registrations and Commercial Information
and Documents containing the same (including any of the same in the possession
of a Sub-licensee).

(d)         Commensurate with Legal Requirements, to the extent held by the
Licensee, it shall as soon as reasonably practicable after termination transfer
to the Licensor or its nominee all right, title and interest in all relevant
Product Registrations held by the Licensee for the relevant Product(s), and the
Licensee shall execute all necessary and appropriate letters to the FDA and
other Regulatory Authorities in the Territory (if any) to ensure that ownership
of the Product Registrations are transferred to the Licensor (i) for United
States Product Registrations, within 15 days of termination, and for Canadian
Product Registrations, within 70 days of termination. The date upon which a
Product Registration is registered in the Licensor's name shall be known as the
“Transfer Date”. In the event that such a transfer is not possible under Legal
Requirements, the Licensee shall use reasonable efforts at Licensor's sole cost
and expense to ensure that the Licensor has the benefit of the relevant Product
Registrations and, to this end, consents to any Regulatory Authority in the
Territory cross-referencing to the data and information on file with any
Regulatory Authority as may be necessary to facilitate the granting of second
Product Registrations to the Licensor in the terminated countries. In such
circumstance as soon as the second Product Registrations are given to the
Licensor, the Licensor will, so far as possible under Legal Requirements, cancel
the corresponding first Product Registration. Further from the date of
submission of the appropriate letters to the Regulatory Authorities in the
Territory (if any) necessary to ensure that ownership of the Product
Registrations is given to the Licensor until the Product Registrations are
actually transferred to the Licensor or second Product Registrations are issued
by such Regulatory Authorities, the Licensee shall, at Licensor's sole cost and
expense:

(i)          submit all necessary filings, correspondence and reports, attend
all necessary meetings and otherwise conduct such other activities as are
necessary to maintain the Product Registrations;

(ii)        as soon as practicably possible submit to the Licensor copies of all
filings and correspondence that are submitted to any Regulatory Authority to the
extent they relate to all relevant Product(s) in the Territory; and

(iii)       provide the Licensor with advance written notice of any meetings or
telephone calls with any Regulatory Authority in the Territory relating to
Product Registrations and allow the Licensor to participate in all such meetings
or telephone calls.

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(e)         The Licensee shall as soon as reasonably practicable notify the
Licensor of the amount of stocks of Product owned by it (title not having passed
to a customer) and the precise location of such stocks with corresponding stock
numbers, and the amount of such stocks subject to customer orders but not yet
delivered. The Licensor shall have the option (exercisable by written notice to
the Licensee to be given not more than one (1) month termination), either (i) to
inspect and purchase from the Licensee a price equal to Cost of Manufacture all
of or any part of stocks of the Product held by the Licensee which are not
subject to orders from customers and are in good and saleable condition or (ii)
permit the Licensee to sell all or some of such stocks of Products for a period
up to and no later than the Licensee holds its own Regulatory Approval for
Product in the relevant country. All other stocks of Products shall be destroyed
by the Licensee.

(f)         The Licensee shall inform the Licensor of the details of all stocks
including batch numbers sold by the Licensee, its Affiliates, or Sub-licensees
in the previous six (6) months to distributors or wholesalers and the names and
other details of such distributors or wholesalers.

(g)         The Licensee shall be entitled to invoice and collect and retain
payment for Products sold by Licensee prior to termination, and shall be
responsible for any payments, rebates, administrative fees or chargebacks
(“Commercial Payments”) due to customers (including those payments due under
managed care agreements and agreements with health maintenance organization) for
Products sold by the Licensee, its Affiliates and Sub-Licensees prior to the
termination date and the Licensor shall be responsible for Commercial Payments
to customers for Products sold or dispensed thereafter. In the event that, with
respect to Products sold or dispensed during the Calendar Quarter in which the
termination date occurs, the Parties cannot determine the date on which such
Products were sold, then the Party that has made a Commercial Payment for such
Product shall be entitled to obtain reimbursement from the other party on a pro
rata basis for such Commercial Payment (with the Licensee's pro rata share
constituting the proportion of days in the Calendar Quarter up to and including
the termination date, and the Licensor's pro rata share constituting the
proportion of days in such Quarter following the termination date). Either Party
that has made a Commercial Payment, all or a portion of which is the
responsibility of the other Party, shall submit a payment request to the other
Party, with supporting documentation, and such other Party shall reimburse the
requesting Party for the Commercial Payment (or portion thereof) for which it is
responsible within thirty (30) days of receipt of such request.

(h)         The Licensee shall be responsible for any rebates due to a
governmental entity (“Government Rebates”) applicable to Product sold by the
Licensee, its Affiliates, or Sub-licensees prior to the termination date. The
Parties acknowledge that the request for such payments is submitted to the
National Drug Code holder (or its equivalent outside the USA) of the Product
and, as such, the Licensee will receive, process and pay Government Rebates on
all Product bearing Licensee National Drug Code and shall within 30 days of
payment, submit to the Licensor an invoice for the amounts of any Government
Rebates made in relation to Product sold after the termination date. In the
event that, with respect to Product sold or dispensed during the Calendar
Quarter in which the termination date occurs, the Parties cannot determine the
date on which such Product was sold or dispensed, then the Party that has made a
Government Rebate for such Product shall be entitled to obtain reimbursement
from the other Party on a pro rata basis for such Government Rebate (with the
Licensee's pro rata share constituting the proportion of days in the Calendar
Quarter up to and including the termination date, and the Licensor's pro rata
share constituting the

48

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proportion of days in such Calendar Quarter following the termination date).
Either Party that has made a Government Rebate, all or a portion of which is the
responsibility of the other Party, shall submit a payment request to the other
Party, with supporting documentation, and such other Party shall reimburse the
requesting Party for the Government Rebate (or portion thereof) for which it is
responsible within thirty (30) days of receipt of such request.

(i)          The Licensee shall be responsible for returns from any customer in
respect of all Product sold by the Licensee, its Affiliates, or Sub-licensees
prior to the termination date and the Licensor shall be responsible for returns
in respect of all Product sold or dispensed after the termination date,
regardless of when such return occurs. Neither Party shall seek to encourage
Product returns or accept Product returns other than in the ordinary course of
business save, in each case, with the written consent of the other Party. The
Licensee shall process all Product returns received by it and shall destroy the
returned Product. The Licensee shall reimburse the Licensor (within ten (10)
days of request therefor) with respect to any returns of Product sold on or
prior to the termination date for all costs and expenses relating to the return,
including the actual cost of destruction and related administrative costs and
expenses.

(j)          The Licensee will transfer to the Licensor the domain name for the
internet website established by the Licensee.

(k)         To the extent permitted by applicable Law, for a period not to
exceed ninety (90) days, Licensee will reasonably cooperate at Licensor’s sole
cost and expense as reasonably requested by Licensor, in assisting with the
smooth transition of the Commercialization of the Product in the Territory from
Licensee to Licensor

14.8      Termination of the Agreement shall be without prejudice to any rights
that shall have accrued to the benefit of either party before such termination,
including the right of either party to receive or recover: (i) damages sustained
by reason of the breach of the Agreement by the other party, or (ii) any
payments for Products which may then be owing under the terms of the Agreement
(including any invoice). In addition, the following provisions of this Agreement
shall survive termination of this Agreement:

(a)         Section 11 (Confidentiality);

(b)         this Section 14 (Duration and termination of the agreement);

(c)         Section 16 (Governing law and disputes); and

(d)         any provision of this Agreement necessary for its interpretation or
enforcement.

14.9      If:

(a)         a Court pursuant to Section 16.2Error! Reference source not found.
finds that Licensee is obligated to transfer the Product Registrations pursuant
to Section 14.7(d) has not done so in a timely manner; or

(b)         if Licensee agrees in any settlement or otherwise that it is obliged
to transfer the Product Registrations pursuant to Section 14.7(d),

then the Licensor shall be entitled to equitable relief pursuant to Section 16.2
including specific performance of such obligation, without a need to post bond
or other surety.

15.        Assignment/succession

15.1      Subject to Section 15.2, this Agreement shall not be assignable nor
shall the rights licensed hereunder or the ownership of the NDA (other than
pursuant to Section 5.10) be transferable

49

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in any way by either Party except by prior written consent of the other Party,
not to be unreasonably withheld, conditioned or delayed; provided, however,
that:

(a)         other than with respect to assignment of the ownership of the NDA,
which assignment shall require the consent of the other Party, not to be
unreasonably withheld, conditioned or delayed,  either Party may assign this
Agreement in whole or in part to a corporate Affiliate on reasonable prior
written notice to the other Party of such assignment on the condition that the
assigning Party shall remain liable hereunder for the prompt payment and
performance of all obligations of the assignee;

(b)         this Agreement may be assigned by a Party to a Third Party in
connection with a sale or transfer of all or substantially all of such Party's
business or assets to which this Agreement relates or in connection with a
merger or consolidation transaction involving such Third Party provided always
that such Third Party gives a written deed of undertaking to the non-affected
Party agreeing to abide by all the obligations under this Agreement of the
assigning Party; and

(c)         Licensee may pledge, grant a security interest, lien or charge in,
or other encumbrance upon, any of Licensee’s rights or interests in this
Agreement (and may assign this Agreement or the rights hereunder, in whole or in
part in connection with any of the foregoing), including without limitation
pursuant to the terms of the Term Loan Agreement (and any amendment,
restatement, replacement or refinancing thereof) and any related documents.

15.2      If a Bankruptcy Event occurs with respect to the Licensee, then:

(a)         the Licensee shall not be permitted to assign this Agreement or
transfer its rights hereunder; and

(b)         except as specified in Section 15.1(c), the Licensor shall not be
deemed to have consented to: (i) any assignment by the Licensee of this
Agreement; or (ii) the transfer of any of the Licensee rights contained in this
Agreement.

15.3      This Agreement shall be binding upon, and shall inure to the benefit
of, all permitted assigns.

16.        Governing law and disputes

16.1      This Agreement shall be governed by and construed in accordance with
the Laws of the State of New York, United States without regard to its conflicts
of laws principles.

16.2      The Parties consent to the exclusive jurisdiction of the Federal
courts and the State courts of the State of New York, in each case, located in
the borough of Manhattan, City of New York (the "New York Courts") in any
dispute, suit or action (each, a “Proceeding”) arising out of or relating to
this Agreement or the transactions contemplated hereby, and hereby irrevocably
and unconditionally (i) agrees not to commence any such Proceeding except in
such New York Courts, (ii) agrees that any claim in respect of any such
Proceeding may be heard and determined in the New York Courts, (iii) waives, to
the fullest extent it may legally and effectively do so, any objection which it
may now or hereafter have to the laying of venue of any such Proceeding in any
such New York Court, and (iv) waives, to the fullest extent permitted by Law,
the defense of an inconvenient forum to the maintenance of such Proceeding in
any such New York Court. Each of the parties agrees that a final judgment in any
such Proceeding shall be conclusive and may be enforced in other jurisdictions
by suit on the judgment or in any other manner provided by Law. THE PARTIES
HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO
WAIVE, THE RIGHT TO TRIAL BY JURY IN SUCH PROCEEDINGS.

50

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17.        Miscellaneous

17.1      Force Majeure

Neither Party shall be responsible for any delay or failure to perform its
obligations under the Agreement or shall be liable to the other for loss or
damages for any default or delay caused by conditions beyond its reasonable
control, including but not limited to acts of God, governmental restrictions,
declared or not declared wars or insurrections, strikes, terrorism, floods or
work stoppages. If either of the Parties is so affected it shall give prompt
written notice of such cause to the other Party. The Party giving such notice
shall thereupon be excused from such of its obligations under the Agreement as
it is thereby disabled from performing for so long as it is so disabled.

17.2      Notices

(a)         Any notice (which term shall in this Section 17.2 include any other
formal written communication) required to be given under this Agreement or in
connection with the matters contemplated by it shall, except where otherwise
specifically provided, be in writing in the English language.

(b)         Any such notice shall be addressed as provided in Section 17.2(a)
and may be:

(i)          delivered by hand (which shall include by courier), in which case
it shall be deemed to have been given upon delivery at the relevant address if
it is delivered not later than 17.00 hours on a Business Day, or, if it is
delivered later than 17.00 hours on a Business Day or at any time on a day which
is not a Business Day, at 08.00 hours on the next Business Day; or

(ii)        sent by electronic mail, in which case it shall be deemed to be
given when the E-mail leaves the E-mail gateway of the sender where it leaves
such gateway before 17.00 hours on any Business Day or in any other case at
08.00 hours on the next Business Day after it leaves such gateway and the onus
shall be on the sender to prove the time that the E-mail left its gateway.

(c)         The addresses and other details of the Parties for notices are,
subject to Section 17.2(d):

If to the Licensor, addressed to:

Attention: Michael Ward (President & Chief Executive Officer)

Address:

Æterna Zentaris,  315 Sigma Drive,  Charleston, SC  29486

E-mail address: mward@aezsinc.com

 

If to the Licensee, addressed to:

Attention: Chief Legal Officer

Address: 10 Earlsfort Terrace, Dublin 2, D02 T380

E-mail address: s.long@strongbridgebio.com

(d)         Any Party to this Agreement may notify the other Party of any change
to the address or any of the other details specified in Section 17.2(c),
provided that such notification

51

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shall only be effective on the date specified in such notice or two Business
Days after the notice is given, whichever is later.

17.3      In proving service of any notice in accordance with Section 17.2, it
shall be sufficient to prove that the envelope containing the notice was
properly addressed and delivered by hand to the relevant address or that the
e-mail was sent to the correct e-mail address, as the case may be.

17.4      No Other Rights

Except as otherwise expressly provided in the Agreement, no other right, express
or implied, is granted by the Agreement.

17.5      Further Actions

Each party agrees to execute, acknowledge and deliver such further instruments,
and to do all such other reasonable acts, as may be necessary or appropriate in
order to carry out the purposes and intent of the Agreement.

17.6      Amendment

No amendment, modification or supplement of any provision of the Agreement shall
be valid or effective unless made in writing and signed by a duly authorized
officer or director of each party.

17.7      Waiver

No provision of the Agreement shall be waived by any act, omission or knowledge
of any party or its agents or employees except by an instrument in writing
expressly waiving such provision and signed by a duly authorized officer or
director of the waiving party. The waiver by either Party of a breach or a
default of any provision of this Agreement by the other Party shall not be
construed as a waiver of any succeeding breach of the same or any other
provision, nor shall any delay or omission on the part of either Party to
exercise or avail itself of any right, power or privilege that it has or may
have hereunder operate as a waiver of any right, power or privilege by such
Party.

17.8      Counterparts

The Agreement may be executed in any number of counterparts, each of which need
not contain the signature of more than one party but all such counterparts taken
together shall constitute one and the same agreement. A signed Agreement
received by a party hereto via facsimile will be deemed an original, and binding
upon the party who signed it. Facsimile signatures or signatures sent by email
attachment or telecopy shall be valid and binding to the same extent as original
signatures. This agreement shall not be effective until each party has executed
at least one counterpart.

17.9      Severability

Whenever possible, each provision of the Agreement shall be interpreted in such
manner as to be effective and valid under applicable Law, but if any provision
of the Agreement is held to be prohibited by or invalid under applicable Law,
such provision shall be ineffective only to the extent of such prohibition or
invalidity, without invalidating the remainder of the Agreement.

17.10    Independent Contractors

The relationship between the Licensor and the Licensee created by the Agreement
is one of independent contractors and neither party shall have the power or
authority to bind or obligate

52

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the other. There is no employee-employer relationship or partnership
relationship between the Licensor and the Licensee or any of its
representatives.

17.11    Local Law Requirements

Except as otherwise specifically provided herein, each party shall at their own
expense in their respective countries, take such steps as may be required to
satisfy any Laws or requirements with respect to declaring, filing, recording or
otherwise rendering the Agreement valid.

17.12    Expenses

Each party shall bear its own expenses and costs incurred in the negotiations
leading up to and in preparation of the Agreement and of matters incidental to
the Agreement.

17.13    Entire Agreement of the Parties

The Agreement (including the Schedules) shall constitute and contain the
complete, final and exclusive understanding and agreement of the parties and
cancels and supersedes any and all prior negotiations, correspondence,
understanding and agreements, whether oral or written, between the Licensor and
the Licensee respecting the subject matter thereof.

17.14    Exclusion

The Parties exclude the application of any international statutes on the sales
of goods, including the United Nations Convention on International Contracts for
the Sales of Goods.

17.15    Language

The English version of the Agreement shall be deemed the official and governing
instrument, notwithstanding any translations thereof.

 

[Signature Page Follows]

 

53

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Execution

Intending to be legally bound, the parties have caused the Agreement to be
executed by their duly authorized officers or directors as of the Effective
Date.

 

Aeterna Zentaris GmbH

 

By:

 

 

 

 

 

Name:

Michael Ward

 

 

 

 

Title:

 

 

 

 

 

Its:

CEO

 

 

 

 

 

 

Strongbridge Ireland Limited

 

By:

 

 

 

 

 

Name:

A. Brian Davis

 

 

 

 

Title:

 

 

 

 

 

Its:

Director

 

 

 

 

 

 

54

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Schedule 1

CMO Contracts

 

Objective / Purpose

CMO

Address

Contract

Execution Date

Manufacturing of Boc-AEZS-130, packaging, quality control, batch release,
stability testing and distribution

Flamma SpA

Via Bedeschi 22, 24040

Chignolo d’Isola, Italy

QA

2017-09-12

SA

n.a.

Manufacturing of AEZS-130 drug substance, packaging, labelling, quality control,
batch release and stability testing

PolyPeptide Laboratories France SAS

7 rue de Boulogne,

67100 Strasbourg, France

QA

2017-10-06*

SA

2013-08-21*

Manufacturing drug product, primary packaging, quality control, stability
testing and batch release

Allphamed Pharbil Arzneimittel GmbH

Hildebrandstrasse 12,

37081 Goettingen, Germany

QA

2017-09-27

SA

2013-08-08*

Labeling, secondary packaging, batch release and distribution

Corden Pharma GmbH

Otto-Hahn-Strasse,

68723 Plankstadt, Germany

QA

2017-11-21

SA

In preparation, draft status

Storage of drug product stability samples

Pharbil Pharma GmbH

Reichenberger Strasse 43,

33605 Bielefeld, Germany

n.a.

Internally regulated within NextPharma subsidiaries

Batch certification for export from EU and final batch release to US market

Aeterna Zentaris GmbH

Weismuellerstrasse 50, 60314 Frankfurt am Main, Germany

n.a.

Internally regulated within Aeterna Zentaris

Storage and distribution (3PL services)

ICS AmerisourceBergen

3101 Gaylord Parkway,

Frisco, TX 75034, USA

Statements of Work

In preparation, draft status

 

 

SA: Supply Agreement, QA: Quality Agreement

* Update in progress

 

55

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Schedule 2

Technology Transfer Critical Materials and Timing

 

To the extent not already in the Data Room:

 

Materials

Timing for transfer

Copy of a customer facing slide deck for MCO purposes.

As soon as possible on or after the Effective Date

 

 

Copies of any additional draft/final promotional documents.

As soon as possible on or after the Effective Date

 

Any medical affairs planning documents generated, including any physician lists,
conference planning documents, speaker training materials, etc.  

 

As soon as possible on or after the Effective Date

 

Drafts of any presentations or product-related manuscripts in preparation at the
time of deal closing

 

As soon as possible on or after the Effective Date

 

 

Information pertaining to any requests in the last 12 months for supply of drug
product or funding to support clinical research or expanded access to drug in
the Territory

As soon as possible on or after the Effective Date

 

Copies of batch records and certificates of analysis for any Licensor Materials
to be transferred to Licensee.  This should include the batch records and
certificates of analysis of the input materials used to make each batch of
Licensor Materials (drug product, AEZS-130 drug substance, and Boc-AEZS-130
intermediate).

 

Prior to or upon transfer of the applicable Licensor Material

 

Copies of all pricing, access and reimbursement related material.  Including
requests for proposals, analysis and contracts.

 

As soon as possible on or after the Effective Date

 

 

56

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Schedule 3

FDA Letters

 

FDA NDA TRANSFER LETTER

Month Date, Year

 

Jean-Marc Guettier, MD

Director

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Metabolism and Endocrinology Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

 

Re:       NDA #205598 Macimorelin (AEZS-130, formally ARD-07) Granules for oral
solution

GENERAL CORRESPONDENCE-Transfer of NDA Ownership

 

Dear Dr. Guettier,

 

Reference is made to the NDA 205598 Macimorelin (AEZS-130, formally ARD-07)
Granules for oral solution. Aeterna Zentaris Inc., hereby submits a General
Correspondence-Transfer of NDA ownership to notify that we have transferred
ownership of this application from Aeterna Zentaris Inc., to the new owner:

 

Strongbridge Ireland Limited,

10 Earlsfort Terrace, Dublin 2, D02 T380

900 Northbrook Drive, Suite 200, Trevose, PA 19053

Attn: Susan Thornton, Vice President, Regulatory Affairs

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

 

Effective Month Date, Year, all rights and responsibilities regarding NDA 205598
are transferred to Strongbridge Ireland Limited (“Strongbridge”). Strongbridge
will concurrently notify the Agency of its acceptance of ownership of the
designation under separate cover. A complete copy of the NDA 205598, including
IND #73,196 and Orphan Drug Designation #06-2255, has been provided to
Strongbridge for their files.

 

If there are any questions, or if additional information is required, please
contact me at XXX-XXX-XXXX.

 

Sincerely,

 

{Name}

{Title}

 

57

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FDA NDA ACCEPTANCE LETTER

Month Date, Year

 

Jean-Marc Guettier, MD

Director

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Metabolism and Endocrinology Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

 

Re:       NDA #205598 Macimorelin (AEZS-130, formally ARD-07) Granules for oral
solution

GENERAL CORRESPONDENCE-Transfer of NDA Ownership

 

Dear Dr. Guettier,

 

Pursuant to 21 CFR §314.72, Strongbridge Ireland Limited, hereby notifies the
FDA of a change in ownership of NDA 205598 Macimorelin. As indicated in
correspondence dated XXXX, from Aeterna Zentaris Inc. (copy enclosed), all
rights to NDA 205598 Macimorelin have been transferred from Aeterna Zentaris
Inc. to Strongbridge Ireland Limited, effective Month Date, Year with the
following associated address:

 

Strongbridge Ireland Limited,

10 Earlsfort Terrace, Dublin 2, D02 T380

Attn: Susan Thornton, Vice President, Regulatory Affairs

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

Fax: 215-355-7389

 

Strongbridge Ireland Limited, (“Strongbridge”) has made arrangements with
Aeterna Zentaris Inc. to obtain a complete copy of the NDA 205598, including
supplements, and records that are required to be kept under 21 CFR 314.81. In
addition, Strongbridge reserves the right to request a copy of the application
from FDA's files under the fee schedule in 20.45 of FDA's public information
regulations. Strongbridge hereby commits to the agreements, promises, and
conditions made by the former owner and contained in the application.

 

Provided herein is a new form FDA 356h signed by the Strongbridge agent of
record.

 

If there are any questions, or if additional information is required, please
contact me at 484-589-0395.

 

Sincerely,

 

Susan Thornton

Vice President, Regulatory Affairs

Strongbridge Biopharma (parent company of Strongbridge Ireland Limited)

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395

Mobile: 215-518-2620

s.thornton@strongbridgebio.com

CC: Meghna Jairath, Regulatory Project Manager

58

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FDA IND TRANSFER LETTER

Month Date, Year

 

Jean-Marc Guettier, MD

Director

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Metabolism and Endocrinology Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

 

RE:       IND # 73,196 Macimorelin (AEZS-130, Formerly ARD-07) Granules for Oral
Solution

GENERAL CORRESPONDENCE-Transfer of IND Ownership

 

Dear Dr. Guettier,

 

Reference is made to IND #73,196 originally submitted on February 7, 2007 for
Macimorelin (AEZS-130, Formerly ARD-07) Granules for Oral Solution,  as a
diagnostic for growth hormone deficiency [GHD]. Aeterna Zentaris Inc., hereby
submits a General Correspondence-Transfer of IND ownership to notify that we
have transferred ownership of this application from Aeterna Zentaris Inc., to a
new sponsor:

 

Strongbridge Ireland Limited,

10 Earlsfort Terrace, Dublin 2, D02 T380

Attn: Susan Thornton, Vice President, Regulatory Affairs

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

Fax: 215-355-7389

 

Effective Month Date, Year, all rights and responsibilities regarding IND
#73,196 are transferred to Strongbridge Ireland Limited (“Strongbridge”).
Strongbridge will concurrently notify the Agency of its acceptance of ownership
of the designation under separate cover. A complete copy of the IND #73,196 has
been provided to Strongbridge for their files.

 

If there are any questions, or if additional information is required, please
contact me at XXX-XXX-XXXX.

 

Sincerely,

 

{Name}

{Title}

 

59

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FDA IND ACCEPTANCE LETTER

Month Date, Year

 

Jean-Marc Guettier, MD

Director

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Metabolism and Endocrinology Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

 

Re:       IND # 73,196 Macimorelin (AEZS-130, Formerly ARD-07) Granules for Oral
Solution

Transfer of IND Ownership

 

Dear Dr. Guettier,

 

Reference is made to IND #73,196 originally submitted on February 7, 2007 for
Macimorelin (AEZS-130, Formerly ARD-07) Granules for Oral Solution,  as a
diagnostic for growth hormone deficiency [GHD].

 

Pursuant to 21 CFR §312, Strongbridge Ireland Limited, hereby notifies the FDA
of a change in ownership of IND #73,196 for Macimorelin.  As indicated in
correspondence dated XXXX, from Aeterna Zentaris Inc., (copy enclosed), all
rights to IND #73,196 for Macimorelin have been transferred from Aeterna
Zentaris Inc. to Strongbridge Ireland Limited, effective Month Date, Year with
the following associated address:

 

Strongbridge Ireland Limited,

10 Earlsfort Terrace, Dublin 2, D02 T380

Attn: Susan Thornton, Vice President, Regulatory Affairs

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

Fax: 215-355-7389

 

Provided herein is a new form FDA 1571 signed by the Strongbridge U.S. Agent of
record.

 

Strongbridge has made arrangements with Aeterna Zentaris Inc. to obtain a
complete copy of the IND #73,196, including amendments, and records.
Strongbridge hereby commits to the agreements, promises, and conditions made by
the former owner and contained in the application.

 

If there are any questions, or if additional information is required, please
contact me at 484-589-0395.

 

Sincerely,

 

Susan Thornton

Vice President, Regulatory Affairs

Strongbridge Biopharma (parent company of Strongbridge Ireland Limited)

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395

Mobile: 215-518-2620

s.thornton@strongbridgebio.com

CC: Meghna Jairath, Regulatory Project Manager

60

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FDA ORPHAN DESIGNATION TRANSFER LETTER

Month Date, Year

 

Gayatri R. Rao, MD., JD.

Director, Office of Orphan Products Development

Food and Drug Administration

WO32-5271

10903 New Hampshire Avenue

Silver Spring, MD 200993-002

 

RE:       Designation #06-2255, Macimorelin Acetate as a Diagnosis of Growth
Hormone Deficiency

Transfer of Orphan Drug Designation Ownership

 

Dear Dr. Rao,

 

Reference is made to Orphan Drug Designation (ODD) #06-2255, originally approved
on May 14, 2007, for Macimorelin acetate as a Diagnosis of Growth Hormone.
Aeterna Zentaris Inc., hereby submits a Transfer of Orphan Drug Designation
ownership to notify that we have transferred ownership of this application from
Aeterna Zentaris Inc., to a new sponsor:

 

Strongbridge Ireland Limited,

10 Earlsfort Terrace, Dublin 2, D02 T380

Attn: Susan Thornton, Vice President, Regulatory Affairs

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

Fax: 215-355-7389

 

Effective Month Date, Year, all rights and responsibilities regarding ODD
#06-2255 are transferred to Strongbridge Ireland Limited.  Strongbridge Ireland
Limited will concurrently notify the Agency of its acceptance of ownership of
the designation under separate cover. A complete copy of the ODD #06-2255 has
been provided to Strongbridge Ireland Limited for their files.

 

If there are any questions, or if additional information is required, please
contact me at XXX-XXX-XXXX.

 

Sincerely,

 

{Name}

{Title}

 

61

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FDA ORPHAN DESIGNATION ACCEPTANCE LETTER

Month Date, Year

Gayatri R. Rao, MD., JD.

Director, Office of Orphan Products Development

Food and Drug Administration

WO32-5271

10903 New Hampshire Avenue

Silver Spring, MD 200993-002

 

RE:       Designation #06-2255, Macimorelin Acetate as a Diagnosis of Growth
Hormone Deficiency

Transfer of Orphan Drug Designation Ownership

 

Dear Dr. Rao,

 

Reference is made to Orphan Drug Designation (ODD) #06-2255 originally approved
on May 14, 2007 for Macimorelin acetate as a Diagnosis of Growth Hormone.

 

Pursuant to 21 CFR §316.27,  Strongbridge Ireland Limited hereby notifies the
FDA of a change in ownership of IND #73,196 for Macimorelin.  As indicated in
correspondence dated XXXX, from Aeterna Zentaris Inc., (copy enclosed), all
rights to IND #73,196 for Macimorelin have been transferred from Aeterna
Zentaris Inc. to Strongbridge Ireland Limited (Strongbridge), effective Month
Date, Year with the following associated address:

 

Strongbridge Ireland Limited,

10 Earlsfort Terrace, Dublin 2, D02 T380

Attn: Susan Thornton, Vice President, Regulatory Affairs

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

Fax: 215-355-7389

 

Provided herein is a new form FDA 1571 signed by the Strongbridge agent of
record.

 

Strongbridge has made arrangements with Aeterna Zentaris Inc. to obtain a
complete copy of the ODD #06-2255, including amendments, and records.
Strongbridge hereby commits to the agreements, promises, and conditions made by
the former owner and contained in the application.

 

If there are any questions, or if additional information is required, please
contact me at 484-589-0395.

 

Sincerely,

 

Susan Thornton

Vice President, Regulatory Affairs

Strongbridge Biopharma (parent company of Strongbridge Ireland Limited)

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395

Mobile: 215-518-2620

s.thornton@strongbridgebio.com

CC: Meghna Jairath, Regulatory Project Manager

 

62

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Schedule 4

Licensor Materials to be Transferred to Licensee

 

API/ Drug substance

 

 

Batch

Units

QC-release ** till

Shipment from

Shipment to

3PL***

Delivery date

Costs

Total Cost

Batch T*

937g

05/2018

Polypetide SaS

7 rue de Boulogne

67100 Strasbourg

France

Allpharmed PHARBIL GmbH (NextPharma)

Hildebrandstr. 12

37081 Goettingen

Germany

World Courier (AmerisourceBergen)

Jun/ 2017

360,000 Euro

360,000€

Batch U****

~1kg

Planned QC-testing in Feb/2018

Polypetide SaS

7 rue de Boulogne

67100 Strasbourg

France

Allpharmed PHARBIL GmbH (NextPharma)

Hildebrandstr. 12

37081 Goettingen

Germany

World Courier (AmerisourceBergen)

Mar/ 2018

~370,000 Euro

370,000€

 

*: relevant for the first DP-batch in scale (9,000-9,500 sachets)

**: QC-testing against the current Drug substance release specification
(D-87575\RS_0830)

***: AeternaZentaris was responsible for the Shipment (Incoterms2010 EXW)

****: relevant for the second DP-batch in scale (9,000-9,500 sachets)

 

63

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Drug product/ finished product

 

 

Batch

Units

Expiry date*

Shipment from

Shipment to

3PL**

Delivery date

Costs

Total Cost

A1710002A

1197

09/2021

CordenPharma GmbH

Otto-Hahn Strasse

68723 Plankstadt, Germany

ICS Brooks

420 International Blvd, Suite 500

KY 40109 US

Schenker MHG (CordenPharma is responsible for the shipment; DDP acc.
Incoterms2010)

Feb 7th, 2018

44,5 Euro/unit + 6,500 Euro validation fee/batch

59,766.50€

A1710003A

1127

09/2021

CordenPharma GmbH

Otto-Hahn Strasse

68723 Plankstadt, Germany

ICS Brooks

420 International Blvd, Suite 500

KY 40109 US

Schenker MHG (CordenPharma is responsible for the shipment; DDP acc.
Incoterms2010)

Feb 7th, 2018

44,5

Euro/unit

+ 6,500 Euro validation fee/batch

56,651.50€

n/a

9,000-9,500***

n/a

CordenPharma GmbH

Otto-Hahn Strasse

68723 Plankstadt, Germany

ICS Brooks

420 International Blvd, Suite 500

KY 40109 US

Schenker MHG (CordenPharma is responsible for the shipment; DDP acc.
Incoterms2010)

Apr/

2018

8,9 Euro/unit + 6,500 Euro validation fee/batch

86,600€-91,050€

n/a

9,000-9,500****

n/a

CordenPharma GmbH

Otto-Hahn Strasse

68723 Plankstadt, Germany

ICS Brooks

420 International Blvd, Suite 500

KY 40109 US

Schenker MHG (CordenPharma is responsible for the shipment; DDP acc.
Incoterms2010)

Q3/

2018

8,9 Euro/unit + 6,500 Euro validation fee/batch

86,600€-91,050€

 

*: QC-testing against the current DrugProduct release specification
(D-87575\RS_0974_02) and Finished Product specification (D-87575\PS_1072_01)

**:  Document: “Process description for handling and flow of CordenPharma
Airfreight shipments”

***: manufacturing of the first validation batch has been started on Jan 12th,
2018; API-batch T is applied

****: manufacturing of the second validation batch is planned in Q3/2018;
API-batch U will be applied

64

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Schedule 5

Disclosure Schedule

This Disclosure Schedule (this “Disclosure Schedule”) is furnished in connection
with

that certain Licence and Assignment Agreement (the “Agreement”), dated on or
around 16 January 2018, by and among Aeterna Zentaris GmbH, a corporation
incorporated under the laws of Germany (the "Licensor”) and Strongbridge Ireland
Limited, a corporation incorporated under the laws of Ireland (the "Licensee").

 

Capitalized terms used but not defined in this Disclosure Schedule have the
meanings set

forth for them in the Agreement. The information in this Disclosure Schedule
represents

exceptions to and qualifications of the representations and warranties set forth
in the corresponding numbered sections of the Agreement, and is arranged to
correspond to the numbered and lettered sections of the Agreement.

 

If there is any inconsistency between the statements in the body of the
Agreement and

those in the Disclosure Schedule (other than specific exceptions set forth as
such with respect to

representations or warranties stated in the Agreement), the statements in the
body of the

Agreement will control. The mention of any matter or event in this Disclosure
Schedule is not an

admission or acknowledgement, in and of itself, that such information is
material either

individually or in combination with other matters or events disclosed herein, or
has resulted in or

would result in a material adverse effect, or is outside the ordinary course of
business. The

information contained in the Disclosure Schedule is disclosed solely for
purposes of the

Agreement, and no information contained herein shall be deemed an admission to
any third party

of any matter whatsoever, including violation of any law or breach of any
agreement.

 

[Remainder of page intentionally left blank]

 

65

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Schedule 12.2(b) and (c)

Licensor Patent Rights

 

The following papers identified by Licensee:

 

(1) EP1572: A novel peptide-mimetic GH secretagogue with potent and selective
GH-releasing activity in man by Broglio et al

 

Picture 2 [sbbp20171231ex1028922e7001.jpg]

(2)

 

Targeting the Ghrelin Receptor

 

Orally Active GHS and Cortistatin Analogs

 

Romano Deghenghi et al,   Endocrine, vol. 22, no. 1, 13–18, October 2003

 

(3) GH-releasing hormone and GH-releasing peptide-6 for diagnostic

testing in GH-deficient adults

 

by Vera Popovic et al; Lancet 2000; 356: 1137.42

 

66

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Schedule 6

Domain Names

1.    macrilen.com

2.    macrilen.org

 

67

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Schedule 7

Licensor Patent Rights

 

 

Title:

"Growth Hormone Secretagogues"

 

 

 

Owner:

Aeterna Zentaris GmbH

 

 

 

Internal No.:

99/25 PH

 

 

 

 

 

 

 

 

 

 

 

Internal No

Country

Application No

Application Date

Patent No

Granted Date

Expiry Date

US 99/25 PH/2

USA

09/880,498

13.06.2001

US 6,861,409 B2

01.03.2005

01.08.2022

US 99/25 PH/3

USA

10/837,620

04.05.2004

US 7,297,681 B2

20.11.2007

01.08.2022

CA-PCT 99/25 PH

Canada

2,407,659

13.06.2001

2,407,659

09.11.2010

13.06.2021

 

 

 

Title:

"Methods and kits to diagnose Growth Hormone Deficiency"

Owner:

Aeterna Zentaris GmbH

Internal No.:

06/05 Z

 

 

 

 

 

 

 

 

Internal No

Country

Application No

Application Date

Patent No

Granted Date

Expiry Date

US-PCT 06/05 Z

USA

12/279,805

19.02.2007

US 8,192,719 B2

05.06.2012

12.10.2027

 

 

 

 

 

Titel:

"Method of Assessing Growth Hormone Deficiency Comprising Oral Administration

Of a Macimorelin Containing Composition and Collecting One or Two

Post-administration Samples"

Owner:

Aeterna Zentaris GmbH

Internal No.:

17/01 Z

 

 

 

 

 

 

 

 

Prio-Anmeldung

Country

Application No

Application Date

Patent No

Granted Date

Expiry Date

US-Prio 17/01 Z

US

62/609,059

21.12.2017

 

 

 

68

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Schedule 8

Supply Chain

 

Picture 1 [sbbp20171231ex1028922e7002.jpg]

 

69

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Schedule 9

Development Plan

 

1.     Pediatric development plan,
based on the Pediatric Investigation Plan as agreed with the EMA:

o     Pediatric development plan to be discussed with FDA

o     Study 1: Ascending single oral doses of macimorelin in at least 24
stratified pediatric patients from 2 to less than 18 years of age with suspected
GDH

o     Study 2: Diagnostic efficacy and safety of macimorelin acetate in at least
50 stratified pediatric patients from 2 to less than 18 years of age with
suspected GDH.

o     Estimated approx. costs 3 – 3.5 Mio EUR

o     Estimated approx. 4 years

 

2.     Phase IV study:

o     Collect data to support label change to two blood draws at 45 and 60 min
to diagnose AGHD

o     A US patent application directed to a Macrilen test with two blood draws
was filed 21-Dec-17

o     Estimated clinical duration approx. 6 months

o     Estimated costs approx. 500 TEUR

 

70

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Schedule 10

PIP Budget

The proposal has been approved by EMA, but must be discussed with FDA and
adapted if necessary.

 

Study AEZS-130-P01

 

Open label, single dose trial to investigate the pharmacokinetics,
pharmacodynamics, safety and tolerability of macimorelin acetate after ascending
single oral doses of macimorelin in paediatric patients from two to less than 18
years of age with suspected GHD.

 

Date of completion: by July 2020

 

Patient number: at least 24 subjects

 

Study AEZS-130-P02

 

Open label, single dose trial to determine the diagnostic efficacy and safety of
macimorelin acetate in paediatric patients from two to less than 18 years of age
with suspected GHD.

 

Date of completion: July 2022

 

Patient number: at least 50 subjects

 

Budget proposal total: US$5,000,000 – 6,000,000

 

 

71

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