Exhibit 10.9





Exhibit 10.9




EXECUTION VERSION




LICENSE AGREEMENT




BY AND BETWEEN




OSTEOLOGIX LIMITED




AND




LES LABORATOIRES SERVIER




AND




INSTITUT DE RECHERCHES INTERNATIONALES SERVIER




July 30, 2010




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TABLE OF CONTENTS



EXECUTION VERSION





SUMMARY



	 	 	 	 	 
	ARTICLE 1 DEFINITIONS
	 	 	4	 
	ARTICLE 2 DEVELOPMENT, REGISTRATION, SUPPLY AND COMMERCIALIZATION
	 	 	10	 
	ARTICLE 3 FINANCIAL TERMS
	 	 	16	 
	ARTICLE 4 LICENSES
	 	 	20	 
	ARTICLE 5 OWNERSHIP AND INTELLECTUAL PROPERTY
	 	 	21	 
	ARTICLE 6 CONFIDENTIALITY
	 	 	28	 
	ARTICLE 7 REPRESENTATIONS, WARRANTIES AND COVENANTS
	 	 	31	 
	ARTICLE 8 INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY
	 	 	35	 
	ARTICLE 9 TERM AND TERMINATION
	 	 	37	 
	ARTICLE 10 GOVERNING LAW AND DISPUTE RESOLUTION ARTICLE
	 	 	42	 
	ARTICLE 11 GENERAL PROVISIONS
	 	 	43	 






			
	 	 	 
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LICENSE AGREEMENT




THIS LICENSE AGREEMENT (the “Agreement”) is made effective as of July 30, 2010 (the “Effective
Date”) by and between OSTEOLOGIX Limited, a private company organized under the laws of the
Republic of Ireland, having offices at                     , (“OSTEOLOGIX”), and Les Laboratoires
SERVIER, a company organized under the laws of France, having offices at 22 rue Garnier, 92200
Neuilly sur Seine Cedex, France and Institut de Recherches Internationales SERVIER, a company
organized under the laws of France, having offices at 6, Place des Pléiades, 92415 Courbevoie
(hereinafter collectively referred to as “SERVIER”). OSTEOLOGIX and SERVIER are sometimes referred
to herein individually as a “Party” and collectively as the “Parties.”



RECITALS




WHEREAS, OSTEOLOGIX owns or has rights under certain patents, patent applications, other
valuable technology and know-how relating to strontium salts and combinations with strontium, and
may develop or acquire additional related rights;



WHEREAS, SERVIER is a global company devoted to discovering, developing, manufacturing and
marketing human pharmaceutical products;



WHEREAS, SERVIER desires to further research, develop, register and commercialize any
pharmaceutical specialty (i.e., as “specialty” is used in this Agreement, a pharmaceutical
preparation) containing strontium malonate [***], and OSTEOLOGIX desires to have such specialties
developed, registered and commercialized in the Territory, in accordance with this Agreement;



WHEREAS, SERVIER desires to obtain from OSTEOLOGIX certain exclusive rights and licenses for
the research, development and commercialization of pharmaceutical specialty(ies) containing
strontium malonate [***] and OSTEOLOGIX is willing to grant to SERVIER such rights and licenses on
the terms and conditions set forth below;



In consideration of the premises and of the mutual covenants and obligations set forth herein,
the Parties hereby agree as set out below.



			
	 	 	 
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ARTICLE 1

DEFINITIONS





The following capitalized terms shall have the following meanings:



1.1 “Affiliate” means a Person that, directly or indirectly, through one or more
intermediaries, controls, is controlled by or is under common control with SERVIER or OSTEOLOGIX.
For purposes of this definition, “control” means the possession, direct or indirect, of the power
to cause the direction of the management and policies of a Person, whether through ownership of
fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise.
[***]




1.2 “Agreement” shall have the meaning set forth in the first paragraph of this Agreement.



1.3 “Applicable Laws” means all laws, statutes, ordinances, codes, rules and regulations that
have been enacted by a Government Authority and are in force as of the Effective Date or come into
force during the Term, in each case to the extent that the same are applicable to the performance
by the Parties of their respective obligations under this Agreement.



1.4 “Approval Application” means any application necessary and appropriate to obtain a
Regulatory Approval, together with all required documents, data and information concerning any
Licensed Product or Combination Product that is the subject of such application.



1.5 “Business Day” means any day (other than Saturday, Sunday or federal or state legal
holiday) on which banking institutions are open for business in Dublin, Ireland and Paris, France.



1.6 “Calendar Quarter” means for each calendar year, each of the three month periods ending
March 31, June 30, September 30 and December 31; provided, however, that (a) the first Calendar
Quarter of any particular period shall extend from the commencement of such period to the end of
such Calendar Quarter as set forth above; and (b) the last Calendar Quarter shall end upon the
expiration or termination of this Agreement, and in the case of each of (a) and (b), applicable
payments shall be prorated for partial Calendar Quarters.



			
	 	 	 
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1.7 “Combination Product” means a product, Covered by a Valid Claim, that contains a Compound
and one or more active principle.



1.8 “Compound(s)” means [***], Covered by a Valid Claim under the OSTEOLOGIX Patent Rights in
any country in the Territory on the Effective Date or thereafter. [***]



1.9 “Confidential Information” shall have the meaning set forth in Article 6.1
(Confidentiality; Exceptions).



1.10 “Control” means, with respect to item, intellectual property, or other information, that
the Party named as having Control (or an Affiliate controlled by such Party) owns such item,
intellectual property, or other information, or otherwise possesses the ability to grant a license
or sublicense under such intellectual property as granted herein without violating the terms of any
agreement or other arrangement with a Third Party.



1.11 “Cover” means, when used with reference to a Patent Right in relation to any compound or
product, that the use, development, manufacture, import, marketing, distribution, sale or offer for
sale, or other exploitation of the compound or product would infringe a Valid Claim of a Patent
Right in the absence of the license under such Patent Right granted herein. For avoidance of
doubt, for purposes of this definition, a Valid Claim that is part of a pending application (rather
than an issued patent) shall be treated as if such Valid Claim were part of an issued patent.



1.12 “Data” means all non-clinical data, clinical data, CMC data, clinical pharmacology data,
research data and all regulatory documentation and filings and Regulatory Approvals submitted or
obtained in or outside the Territory together with its supporting data and regulatory
correspondence and rights to reference the same, in each case pertaining to any Compound, Licensed
Product, and/or Combination Product which are Controlled by each Party at any time during the Term
of this Agreement. [***]



1.13 “Disclosing Party” shall have the meaning set forth in Article 6.1 (Confidentiality;
Exceptions).



1.14 “Effective Date” shall have the meaning set forth in the first paragraph of this
Agreement.



1.15 “EMA” means the European Medicines Agency, and any successor thereto.



			
	 	 	 
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1.16 “Field” means [***]



1.17 “First Commercial Sale” means [***]




1.18 “Generic Competitor” means, with respect to any Licensed Product in a country, [***]



1.19 “Government Authority” means any supranational, national, regional, state or local
government, court, governmental agency, authority, board, bureau, instrumentality or regulatory
body, or any other entity exercising executive, legislative, judicial, regulatory, taxing or
administrative functions of a government with jurisdiction over the applicable matter.



1.20 “Improvement(s)” means [***] Unless otherwise provided herein, ownership of Improvements
(whether patentable or not) shall be determined according to the laws of inventorship where the
invention takes place. [***]




1.21 “Infringement” shall have the meaning set forth in Article 5.4.1 (Notice).



1.22 “Inspected Party” shall have the meaning set forth in Article 2.8 (Regulatory
Inspections).



1.23 “Know-How” means information, data (including Data) and proprietary rights of any type
whatsoever (other than Patent Rights and trademarks) in any tangible or intangible form whatsoever,
including, without limitation, inventions, practices, methods, techniques, specifications,
formulations, formulae, knowledge, know-how, skill, experience, test data and other similar
information.



1.24 “Licensed Product(s)” means any pharmaceutical preparation in final form for commercial
sale licensed to SERVIER under this Agreement, that contains a Compound and has received Regulatory
Approval in any country of the Territory (if Regulatory Approval is required for sale of such
pharmaceutical preparation).




1.25 “Losses” shall have the meaning set forth in Article 8.1 (Indemnification by SERVIER).



1.26 “MAA” shall mean a marketing authorization application filed with the EMA pursuant to the
centralized approval procedure in Europe or to national approval procedure with
the applicable Governmental Authority of a country of the Territory outside the European
Union.



			
	 	 	 
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1.27 “MHLW” means the Ministry of Health, Labor and Welfare, otherwise referred to as
“Koseisho,” or any successor thereto, which governs the review of human pharmaceutical products in
Japan.




1.28 “Net Sales”: [***] means [***]



[***]




[***]




“Net Sales” shall not include any consideration received with respect to a sale, use or other
disposition of any Licensed Product in a country as part of a clinical trial to be performed in
order to seek Regulatory Approval from the applicable Regulatory Authority.



In the event that a Compound or Licensed Product is sold as part of a Combination Product (for
purposes of this definition, in which an active principle therein in addition to the Compound is
covered by a claim of an issued or pending (for less than [***] years) Patent in the country of
sale, which claim has not been judged to be invalid or unenforceable (each of the Compound and such
other active principle, a “Patented Component”), Net Sales, for the purposes of determining royalty
payments on the Combination Product, shall mean [***]




[***]




[***]




1.29 “OSTEOLOGIX” shall have the meaning set forth in the first paragraph of this Agreement.



1.30 “OSTEOLOGIX Know-How” means Know-How Controlled as of the Effective Date or thereafter
during the Term by OSTEOLOGIX that is necessary or useful to manufacture, have manufactured, use,
sell, have sold, import and export Licensed Products and/or Combination Products in the Territory.



1.31 “OSTEOLOGIX IP” shall comprise OSTEOLOGIX Know-How and OSTEOLOGIX Patent Rights.



			
	 	 	 
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1.32 “OSTEOLOGIX Patent Rights” means any Patent Right Controlled by OSTEOLOGIX as of the
Effective Date or thereafter during the Term necessary or useful to develop, manufacture, have
manufactured, use, have used, sell, have sold, import and export Licensed Products and/or
Combination Products, including but not limited to the Patent Rights listed in Exhibits A and B.



1.33 “Party” or “Parties” shall have the meaning set forth in the first paragraph of this
Agreement.



1.34 “Patents” means all patents and patent applications, and all continuing and divisional
patent applications, continuations-in-part and reissue applications claiming priority, indirectly
and directly, to such applications, and all patents issuing therefrom in the relevant territory as
well as any patent term extensions.




1.35 “Patent Costs” means [***]



1.36 “Patent Rights” means (a) patent applications and patents Controlled by a Party at any
time during the Term relating to the Compounds, Licensed Products, and/or Combination Products,
including without limitation patent applications and patents with respect to such Party’s
Improvements; (b) all divisional, continuation, continuation-in-part or substitute applications
which claim priority from any of the patent applications within (a) above; (c) all patents that may
issue on any of the patent applications within (a) or (b) above; (d) all extensions,
re-examinations, or reissues of patents within (a) or (c) above. [***]




1.37 “Person” means any person or legal entity.



1.38 Prior CDA” means the Non-Disclosure Agreement between Les Laboratoires SERVIER and
OSTEOLOGIX dated February 3rd, 2010.



1.39 “Reasonable Efforts” means, with respect to the efforts to be expended by a Party
hereunder, [***]



1.40 “Receiving Party” shall have the meaning set forth in Article 6.1 (Confidentiality;
Exceptions).



1.41 “Regulatory Approval” means, with respect to a nation or, where applicable, a
multinational jurisdiction, any approvals, licenses, registrations or authorizations necessary for
the manufacture, marketing and sale of a Licensed Product and/or a Combination Product in such
nation or such jurisdiction, including with limitation any MAA.



			
	 	 	 
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1.42 “Regulatory Authority” means a Government Authority that has responsibility for granting
any licenses or approvals or granting pricing and/or reimbursement approvals necessary for the
marketing and sale of a pharmaceutical product in any country, including without limitation the
MHLW.



1.43 “Responsible Executive” means [***] of OSTEOLOGIX or [***] of SERVIER, or an executive
officer of a Party designated by such Party with authority to bind such Party.




1.44 “SERVIER” shall have the meaning set forth in the first paragraph of this Agreement.




1.45 “SERVIER IP” shall comprise SERVIER Know-How and SERVIER Patent Rights.



1.46 “SERVIER Know-How” means Know-How Controlled as of the Effective Date or thereafter
during the Term by SERVIER and that is used by SERVIER to manufacture, have manufactured, use,
sell, have sold, import and export Licensed Products and/or Combination Products in the Territory
[***].



1.47 “SERVIER Patent Rights” means any Patent Right Controlled by SERVIER as of the Effective
Date or thereafter during the Term and that is used by SERVIER to develop, manufacture, have
manufactured, use, have used, sell, have sold, import and export Licensed Products and/or
Combination Products [***].



1.48 “Sublicensee” means with respect to a particular Licensed Product and/or Combination
Product, a Third Party to whom a Party has granted directly or indirectly (i) a license to make and
sell such Licensed Product and/or Combination Product, or (ii) a right or license to market,
promote or distribute such Licensed Product and/or Combination Product.




1.49 “Term” shall have the meaning set forth in Article 9.1.1 (Expiration).



1.50 “Territory” means all territories and countries throughout the world, except the United
States and its territories and possessions [***].



			
	 	 	 
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1.51 “Third Party” means any Person other than OSTEOLOGIX or SERVIER or their respective
Affiliates.




1.52 “Valid Claim” means [***]



ARTICLE 2

DEVELOPMENT, REGISTRATION, SUPPLY AND COMMERCIALIZATION





2.1 Development



Subject to the terms and conditions of this Agreement, SERVIER shall be responsible[***] to conduct
the development of the Compound(s) in the Field in the Territory, [***] as may be necessary to
register the Licensed Products and/or any Combination Products in the Territory.



During the first [***] years following the Effective Date, SERVIER will provide [***] reports to
OSTEOLOGIX: [***]



After the first [***] years following the Effective Date, SERVIER will provide annual reports to
the OSTEOLOGIX: [***]



[***]




During the first [***] years following the Effective Date, OSTEOLOGIX will provide biannual reports
(on October 1 and April 1) to SERVIER setting forth its plan for development in the next twelve
(12) months covering the clinical trials to be commenced, and Regulatory Approvals planned for
filing (and covering all such activities conducted or planned by OSTEOLOGIX’s Affiliates and
Sublicensees as if such activities were conducted or planned by such Party). After the first [***]
years, OSTEOLOGIX will provide annual reports (on October 1) to SERVIER setting forth its plan for
development in the next twelve (12) months covering the clinical trials to be commenced, and
Regulatory Approvals planned for filing (and covering all such activities conducted or planned by
OSTEOLOGIX’s Affiliates and Sublicensees as if such activities were conducted or planned by such
Party).



Upon either Party’s reasonable request, but no more often than [***] per year, the Parties shall
meet to discuss their development strategies and outcomes. Such meetings may be in person or via
telephone or video conference or other mutually agreeable means. Each Party shall decide who will
attend such meeting on its side and send a list of participant(s) to the other Party at
least two weeks in advance. Each Party shall bear its own personnel and travel costs and expenses
relating to such meetings.



			
	 	 	 
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2.2 Exchange of Data



Promptly after the Effective Date OSTEOLOGIX shall provide to SERVIER all Data from any and
all clinical trials, non-clinical studies, and CMC studies of the Compounds that are completed as
of the Effective Date. During the term of this Agreement, each Party shall provide to the other
Party all Data to the extent Controlled by such Party, in a timely fashion and as promptly as
possible for use by such other Party in accordance with this Article 2.2 (Exchange of Data).
SERVIER will only use and disclose to Third Parties the Data provided by OSTEOLOGIX as may be
necessary or useful for development, manufacture, registration, promotion, distribution and
commercialization of Licensed Products (and/or Combination Products) in the Territory; and in
accordance with Article 6 (Confidentiality) or as may otherwise be agreed by OSTEOLOGIX and
SERVIER. SERVIER may not use any Data (or permit any Third Party to use Data) provided by
OSTEOLOGIX outside the Territory, nor for any products other than the Licensed Products (and/or
Combination Products). OSTEOLOGIX shall only use or disclose to Third Parties the Data provided by
SERVIER as is reasonably necessary or useful for purposes of the activities described in Article
2.6 (Pharmacovigilance; Exchange of Safety Information and Quality Issues), for purposes of
complying with Applicable Laws and for legally required communications with Regulatory Authorities
(including without limitation provision of safety updates to the U.S. Food and Drug Administration
(“FDA”)) and, [***]. OSTEOLOGIX may, but shall have no obligation to, develop and commercialize
Compounds, Licensed Products and /or Combination Products outside the Territory. [***]




2.3 Regulatory Submissions



SERVIER will use Reasonable Efforts to obtain Regulatory Approval for the Licensed Products
and/or any Combination Products in the countries of the Territory set forth in Exhibit C. For the
European Union, SERVIER will make a centralized filing with the EMA and will inform OSTEOLOGIX of
such.



[***]




OSTEOLOGIX shall provide SERVIER with copies of draft correspondence from OSTEOLOGIX to the US FDA
relating to Compound prior to OSTEOLOGIX’s submission of
such correspondence to the US FDA and shall provide SERVIER draft copies of OSTEOLOGIX’s clinical
trial protocols for such clinical trials pertaining to the Compound performed outside the
Territory.



			
	 	 	 
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Each Party shall provide the other with a copy of any letter or other written document to or from a
Regulatory Authority and within thirty (30) days of its receipt, dispatch, or recordation (as
applicable), and shall otherwise keep the other Party informed on an ongoing basis regarding
planned submissions to Regulatory Authorities.




2.4 Supply



SERVIER may request the supply by OSTEOLOGIX of active pharmaceutical ingredients (“APIs”) of
Compounds (being strontium malonate) and/or finished form tablets (“Tablets,” and collectively with
APIs, “OSTEOLOGIX Existing Products”) in OSTEOLOGIX’s control as of the Effective Date for the
performance of clinical and non-clinical studies. Upon SERVIER’s request, the Parties agree to
discuss and agree to sign a separate agreement in due time after the execution of the Agreement
governing such supply containing terms consistent with this Article and such other terms as are
reasonable and customary for arrangements of this type. [***] Other than the supply of OSTEOLOGIX
Existing Products described in this Article 2.4 (Supply), SERVIER shall be solely responsible for
arranging the supply of materials as may be necessary for the development, manufacture and
commercialization of Compounds, Licensed Products and/or Combination Products and otherwise
exercising SERVIER’s rights hereunder.




2.5 Commercialization



SERVIER shall be solely responsible at its cost and shall use Reasonable Efforts to (a) develop a
strategy for marketing, promotion and commercialization of the Licensed Products and/or Combination
Products in the Field in the Territory, [***]




2.6 Pharmacovigilance; Exchange of Safety Information and Quality Issues



Each Party will designate a pharmacovigilance liaison to be responsible for communicating with the
other Party regarding the reporting of adverse drug reactions/experiences.



			
	 	 	 
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The Parties or their licensees will cooperate in the collection, review, assessment, exchange,
tracking and filing of information related to adverse events and quality issues associated with the
Compounds, Licensed Products and/or Combination Products in accordance with all Applicable Laws.
As soon as necessary, the pharmacovigilance and regulatory departments of both Parties or their
licensees shall meet and determine the approach to be taken for the collection, review, assessment,
tracking and filing of information related to adverse events and quality issues associated with the
Compounds, Licensed Products and/or Combination Products, which shall be documented in a separate
safety data exchange and quality agreements which shall be in compliance with all Applicable Laws
(respectively the “Safety Data Exchange Agreement” and the “Quality Agreement” between the Parties)
(provided, however, that the Agreement shall control in the event of any conflict between the terms
of this Agreement and respectively the Safety Data Exchange Agreement and the Quality Agreement).
These documents as well as a safety management plan shall be finalized prior to clinical trials
initiation.



The Safety Data Exchange Agreement and the Quality Agreement will be promptly updated if required
by changes in legal requirements or by agreement between the Parties.



Until such time as the Parties have entered into the Safety Data Exchange Agreement, the Parties
will exchange adverse event information, regardless of causality, involving or associated with the
use of any Compound, Licensed Product, and/or Combination Product on the following schedule:




	•	 	Causally suspected (which means that there is a reasonable possibility that the event may
have been caused by the drug) fatal or life-threatening serious adverse events (whether
expected or not) shall be exchanged within [***] calendar days after the receipt of such
information by a Party or by any of the Party’s Affiliates or agents.







	•	 	Other causally suspected serious adverse events (whether expected or not) should be
exchanged within [***] calendar days after the receipt of the information by a Party or by any
of a Party’s Affiliates or agents.







	•	 	Causally non-suspected (meaning that there is no reasonable possibility that the event may
have been caused by the drug) serious adverse events should be exchanged within [***] calendar
days after the receipt of the information by a Party or by any of a Party’s
Affiliates, licensees or agents.






			
	 	 	 
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	•	 	The Parties shall exchange non-serious adverse event information via study reports or data
management in a time frame that permits each Party to comply with all Applicable Laws,
including complying with the requirements for annual reports for Investigational New Drug
files.






Serious adverse event information shall be exchanged in a Council for International Organizations
of Medical Sciences (“CIOMS”) report format or a substantially similar report format. Information
from animal or epidemiological studies shall be in narrative format.



Each Party shall assist the other to respond to questions or requests for information by Government
Authorities by promptly providing data from their respective safety database.



As between the Parties, SERVIER shall be responsible for reporting all adverse drug
reactions/experiences to the appropriate regulatory authorities in countries in the Territory, and
OSTEOLOGIX shall be responsible for reporting all adverse drug reactions/experiences to the
appropriate regulatory authorities in countries outside the Territory, in accordance with the
Applicable Laws and regulations of the relevant countries and authorities. SERVIER shall ensure
that its Affiliates and Sublicensees comply with such reporting obligations in the Territory and
OSTEOLOGIX shall ensure that its Affiliates and licensees (other than SERVIER and its Sublicensees)
comply with such reporting obligations outside the Territory. These reporting obligations shall
apply to other adverse events as described in the Safety Data Exchange Agreement and Quality
Agreement including but not limited to adverse events occurring from product overdose or from
product withdrawal, as well as any toxicity, sensitivity, failure of expected pharmacological
action, or laboratory abnormality which is, or is thought by the reporter, to be serious or
associated with relevant clinical signs or symptoms.




2.7 Reports; Inspection



Each Party shall prepare and maintain, and shall use Reasonable Efforts to cause its Third Party
manufacturers and Third Party contractors to maintain, accurate and complete records of all
development work with respect to the Licensed Products and/or Combination Products, as consistent
with the responsibilities of such Party under this Agreement. A Party, or such Party’s authorized
representatives, may visit those portions of the facilities of the other Party or
their Third Party contractors or Third Party manufacturers where development is being performed
during normal business hours upon reasonable notice without undue interruption to normal business
operations.



			
	 	 	 
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2.8 Regulatory Inspections



If either Party or its Affiliates or subcontractors (each, an “Inspected Party”) are to be
inspected by a Government Authority regarding the development, manufacture, registration or
commercialization of a Licensed Product and/or Combination Product, the Inspected Party shall
promptly notify the other Party of the inspection in writing as soon as reasonably practicable, and
in advance, if any such inspection is a scheduled inspection. The Inspected Party shall, where
practicable, permit representatives of the other Party to participate as observers with respect to
such inspection, and shall provide the other Party with a written report of any such inspection,
noting with specificity any records or documents reviewed by the regulatory inspector or written
communications provided by or to any Government Authority relating to such inspection. The
Inspected Party shall also provide an opportunity for the other Party to assist in responding to
any issues or concerns relating to such inspections, and shall provide copies of all communications
to and from any Government Authority relating thereto to the other Party. The Parties shall
cooperate in good faith and otherwise mutually support any regulatory inspections of facilities,
clinical sites, contract manufacturers or the like with respect to the Licensed Product and/or
Combination Product, including by using Reasonable Efforts to make available such facilities,
documents, information and/or personnel as are reasonably necessary or useful for such regulatory
inspections by a Government Authority.




2.9 Audit Rights



Each Party shall have the right, during normal business hours, and no more than [***] per
year, with more frequent audits upon agreement of the Parties (such agreement not to be withheld
unreasonably), to inspect and audit: (a) those portions of the facilities of each Party, or any of
its Affiliates or Sublicensees, and subcontractors used in connection with the Licensed Products
and/or Combination Products to ascertain compliance with Applicable Laws and Regulatory Approvals,
including current Good Clinical Practices and Good Manufacturing Practices, provided that the
inspecting Party shall on such occasions be accompanied by a representative of the other Party; and
(b) any of the other Party’s documentation, or its
Affiliates’, Sublicensees’ or subcontractors’ documentation, relating to the Compound(s),
Licensed Products and/or Combination Products and, to the extent permitted by law and any
applicable privacy policies, the medical records of any patient participating in any clinical study
of a Compound being conducted by such Party or its Affiliates or Sublicensees. A Party’s audit
rights shall be limited by bona fide Third Party agreements or confidentiality obligations,
provided, however, that each Party shall use its reasonable efforts to obtain audit and inspection
rights for the other Party under such agreements; and if a Party is unable to obtain such audit
rights for the other Party, then upon request it shall exercise its own rights with respect to such
an audit for the benefit of the other Party.



			
	 	 	 
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ARTICLE 3

FINANCIAL TERMS





3.1 License Fee



In partial consideration of the license rights granted by OSTEOLOGIX to SERVIER under this
Agreement, SERVIER shall pay to OSTEOLOGIX, on the Effective Date and within [***] calendar days
after receipt of the corresponding invoice, an upfront license fee of [***].




3.2 [***]




[***]




3.3 Milestone Payments



SERVIER shall make milestone payments to OSTEOLOGIX based on achievement (by SERVIER, its
Affiliates, or Sublicensees) of clinical development milestones as set forth in this Article 3.3
(Milestone Payments) below. SERVIER shall promptly notify OSTEOLOGIX in writing of the first
achievement of each of the milestones in the table below and the corresponding milestone payment
shall be due within [***] calendar days of occurrence thereof and [***] days after receipt of the
corresponding invoices. Each milestone payment shall only be paid once irrespective of the number
of Licensed Product(s) and/or Combination Product(s) developed and/or commercialized.



	 	 	 
	Milestones	 	Payment
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]






			
	 	 	 
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3.4 Royalties



SERVIER shall pay royalties of [***] on the Net Sales of Licensed Products (including, for purposes
of this Article 3.4 (Royalties), Combination Products) sold by SERVIER, its Affiliates and
Sublicenses in the Territory (other than Japan) until [***] (hereafter the “Initial Period”).
Following the Initial Period and unless otherwise indicated in this Agreement, SERVIER shall then
pay royalties of [***]on the Net Sales of Licensed Products sold by SERVIER, its Affiliates and
Sublicenses in the Territory (other than Japan) for so long as a Licensed Product is sold, under
the Agreement, in a given country.



Those royalties shall be payable on a [***] basis, on Net Sales from the date of First Commercial
Sale on a Licensed Product-by-Licensed Product and country-by-country basis[***].




3.5 Milestones and Royalties for Japan



With respect to Japan, the royalty and milestone payment terms set forth below in this Article 3.5
shall apply.




3.5.1 [***].




3.5.2 [***].




3.5.3 [***].




3.6 [***]



[***]




3.7. Royalty Payments and Reports. Each royalty shall be payable only once with respect to a
particular Licensed Product. SERVIER shall provide a report to OSTEOLOGIX within [***] days after
the end of each [***], certified by an executive officer of SERVIER as accurate and in accordance
with IFRS or successor standards and guidelines thereto, as consistently applied by SERVIER across
all of SERVIER’s products, on a country
by country basis, setting forth (a) the amount of gross sales in euros of Licensed Products
and, if applicable, Combination Products in such quarter, (b) any deductions, withholding,
provision from such amount of gross sales as permitted pursuant to the definition of Net Sales, (c)
a calculation of Net Sales of each Licensed Product and, if applicable, Combination Product for
such quarter, (d) the amount of aggregate Net Sales of each Licensed Product and, if applicable,
Combination Product on a cumulative per year basis for the current year, (e) the market share of
Generic Competitors on a country by country basis, (f) the amount of royalty due on Net Sales with
respect to such Calendar Quarter, and (g) a calculating of Sublicensing Revenue for Japan. Within
[***] days after the end of each [***], SERVIER shall make all royalty and Sublicensing Revenue
(for Japan) payments payable to OSTEOLOGIX under this Agreement with respect to such [***]. Along
with such payments, SERVIER shall also provide detailed information regarding the calculation of
royalties due pursuant to this Article 3.7 (Royalty Payments and Reports), including without
limitation allowable deductions in the calculation of Net Sales of Licensed Products and/or
Combination Products in the Territory.



			
	 	 	 
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3.8. Non-Monetary Consideration. In the event that SERVIER receives any non-monetary
consideration in connection with the sale of Licensed Products (and/or Combination Products) or as
Sublicensing Revenue (for Japan), SERVIER’s payment obligations under this Article 3 (Financial
Terms) shall be based on [***]. In such case, SERVIER shall disclose the terms of any such
arrangement to OSTEOLOGIX and the Parties shall [***] for resolution. For the sake of clarity, the
provision or use of Licensed Products for research purposes to the extent permitted under this
Agreement or as samples for commercial purposes (in reasonable quantities) shall not be considered
a sale for non-monetary consideration.



3.9. Records and Audit



SERVIER shall keep or cause to be kept such records as are required to determine the sums or
credits due under this Article 3 (Financial Terms), including without limitation Net Sales in
countries where Licensed Products (and/or Combination Products) are sold. At the request of
OSTEOLOGIX, SERVIER and its Affiliates and its Sublicensees shall permit an independent certified
public accountant appointed by OSTEOLOGIX and reasonably acceptable to SERVIER, at reasonable times
and upon reasonable notice, to examine those records as may be necessary to determine, with respect
to any calendar year ending not more than [***] prior to OSTEOLOGIX’ request, the correctness or
completeness of any report or
payment made under this Article 3 (Financial Terms). The foregoing right of review may be
exercised only [***] and only [***] with respect to each such periodic report and payment. Results
of any such examination shall be (a) limited to information relating to Licensed Products (and/or
Combination Products), (b) made available to both Parties and (c) subject to the confidentiality
provisions of the Agreement. [***].



			
	 	 	 
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3.10. Taxes and Withholding



All payments due and payable under this Agreement are not subject to withholding tax according
to the article 11 of the double tax treaty signed on March 21st, 1968 between France and the
Republic of Ireland under condition that OSTEOLOGIX provides SERVIER with the necessary
documentation to enable SERVIER to obtain the benefit of a tax exemption.



3.11. Currency



All amounts due and payable and calculations hereunder shall be in Euros. If any currency
conversion shall be required in connection with the calculation of amounts payable hereunder,
SERVIER shall inform OSTEOLOGIX of the exchange rate used and SERVIER will use the same exchange
rate for the conversion of the sale of Licensed Products (and/or Combination Products) as it uses
for the conversion in Euros of the sale of its other pharmaceutical specialties made in other
currencies.



3.12. Payments; Late Payments



SERVIER shall make all payments due and payable to OSTEOLOGIX under this Agreement by wire
transfer of immediately available funds to such account designated by OSTEOLOGIX from time to time
to SERVIER in writing. If any sum due and payable under this Agreement shall not have been paid on
or before the applicable due date, simple interest shall accrue on the unpaid amount at the rate of
[***] per annum (or, if less, the maximum rate permitted under Applicable Law); provided, however,
that no interest shall accrue on any portion of an unpaid amount which is the subject of a good
faith, legitimate dispute. If any such dispute is resolved against SERVIER, late fees shall be
calculated from the date that payment to OSTEOLOGIX originally was due. [***] all payments
hereunder shall be nonrefundable and non-creditable against other payments due hereunder.



			
	 	 	 
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ARTICLE 4

LICENSES





4.1 Research and Development License by OSTEOLOGIX to SERVIER



Subject to the terms and conditions of this Agreement, OSTEOLOGIX hereby grants to SERVIER,
during the Term, a royalty-free, exclusive (even as to OSTEOLOGIX and its Affiliates, [***] right
and license, with the right to grant sublicense rights as set forth below, under the OSTEOLOGIX IP,
to research, use, develop, have developed, make, and have made (a) Compound(s) and any combination
with Compound(s) for use in the Field in the Territory.




4.2 Commercialization License by OSTEOLOGIX to SERVIER



Subject to the terms and conditions of this Agreement, OSTEOLOGIX hereby grants to SERVIER,
during the Term, a royalty bearing, exclusive (even as to OSTEOLOGIX and its Affiliates) right and
license, with the right to grant sublicense rights as set forth below, under the OSTEOLOGIX IP, to
make, have made, use, have used, offer for sale, lease, market, sell, have sold and import and
export Combination Products and/or Licensed Products, solely for use in the Field in the Territory.




4.3 [***]




4.3.1[***]




4.4 [***]




[***]




4.5 Competitive Compounds



4.5.1 [***] years following the First Commercial Sale of a Licensed Product in such given
country (except for Sublicensees in Japan). The period of time shall be computed month by month on
a country by country basis. The foregoing provision shall immediately cease to apply in the event
of termination of the Agreement on a country by country basis solely with respect to the terminated
country(ies).



4.5.2 During the Term, except as set forth in Article 2.2 (Exchange of Data) for the conduct
of clinical trials, neither OSTEOLOGIX, [***], nor OSTEOLOGIX’s controlled Affiliates shall (or
shall have) research, develop, promote, market or commercialize
in a given country of the Territory a pharmaceutical specialty [***]. The foregoing provision
shall immediately cease to apply in the event of termination of the Agreement on a country by
country basis solely with respect to the terminated country(ies).



			
	 	 	 
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4.6 Retained Rights; No Implied License



Except as expressly licensed to SERVIER in Article 4.1 (Research and Development License by
OSTEOLOGIX to SERVIER) and 4.2 (Commercialization License by OSTEOLOGIX to SERVIER), OSTEOLOGIX
retains all rights under the OSTEOLOGIX IP and other intellectual property owned or controlled by
OSTEOLOGIX. SERVIER hereby covenants that it (and its Affiliates and Sublicensees) shall not
practice the OSTEOLOGIX Patent Rights outside the scope of the licenses granted to SERVIER under
this Agreement. Except as otherwise expressly set forth in this Agreement, nothing in this
Agreement shall give either Party any right, title or interest in or to any Patents or other
intellectual property owned by or licensed to the other Party.



ARTICLE 5

OWNERSHIP AND INTELLECTUAL PROPERTY





5.1 Ownership of Intellectual Property and Challenge




5.1.1 OSTEOLOGIX shall retain all right, title and interest in and to the OSTEOLOGIX IP.



5.1.2 SERVIER shall retain all right, title and interest in and to the SERVIER Improvements,
except as otherwise expressly set forth herein.



5.1.3 SERVIER and OSTEOLOGIX shall jointly own all Patents claiming the Joint Improvement
(“Joint Improvement Patents”). Such joint ownership shall be, on a worldwide basis, joint
ownership in accordance with (and bearing with it the same rights in joint ownership interest as
joint ownership under) the laws of the country where such invention takes place.



			
	 	 	 
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5.1.4 Neither SERVIER nor its Affiliates or Sublicensees will directly, indirectly or
otherwise seek through judicial or administrative process to invalidate, oppose or challenge the
validity, enforceability or scope of (any such action, to “Challenge”) any
OSTEOLOGIX Patent Right(s) and, in the event that SERVIER or its Affiliate or Sublicensee so
Challenges the OSTEOLOGIX Patent Rights and such party does not within [***] of OSTEOLOGIX giving
notice to SERVIER cause such Challenge to be dismissed with prejudice, (a) all payment obligations
from SERVIER to OSTEOLOGIX under this Agreement shall automatically be [***] (and this shall apply
to then-future payments); and (b) SERVIER shall reimburse OSTEOLOGIX on a [***] basis (within [***]
after the end of the calendar [***]) for all OSTEOLOGIX legal costs in connection with assessing,
responding to and/or defending against such Challenge in such calendar [***]. [***]




5.1.5 Ownership of Approval Applications And Regulatory Approvals



SERVIER, its Affiliates and Sublicensees shall own or be the holder of all right, title and
interest in all Approval Applications in countries in the Territory necessary to obtain Regulatory
Approvals in the Territory required for marketing and sale of Licensed Products and/or Combination
Products and shall be responsible for the filing thereof, the payment of fees and all other
associated costs, for monitoring clinical experiences and filing associated reports, and fulfilling
all of its regulatory obligations throughout the development, registration and commercialization of
the Licensed Product and/or Combination Products in the Territory. Such Approval Applications,
together with any Regulatory Approvals obtained in connection therewith, shall be filed in
SERVIER’s or its Affiliates’ or Sublicensees’ name and owned or held by SERVIER, its Affiliates or
Sublicensees, except as expressly set forth herein.




5.2 Disclosure



As of the Effective Date and on a regular basis thereafter, OSTEOLOGIX shall promptly
disclose to SERVIER any OSTEOLOGIX IP, OSTEOLOGIX Improvements pertaining to the Compounds,
Licensed Products and/or Combination Products made by or on behalf of OSTEOLOGIX during the Term
(including, without limitation, OSTEOLOGIX Improvements of Third Parties acting on behalf of
OSTEOLOGIX).




5.3 Filing, Prosecution and Maintenance of OSTEOLOGIX Patent Right(s)



As of the Effective Date, OSTEOLOGIX shall, under SERVIER’s direction and costs, be in charge of
the filing, prosecution and maintenance of OSTEOLOGIX Patent Right(s) in the Territory. SERVIER
shall pay for the Patent Costs of all OSTEOLOGIX Patent Right(s) in the SERVIER Territory, and
SERVIER shall not instruct OSTEOLOGIX in any manner that, in OSTEOLOGIX’ reasonable judgment would
result in reduced or weakened patent coverage
(and OSTEOLOGIX shall not be required to comply with any such instruction). SERVIER shall give its
instructions to OSTEOLOGIX in due time so that OSTEOLOGIX can implement SERVIER’s patent strategy
(including patent defense strategy) in the Territory.



			
	 	 	 
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SERVIER shall have the opportunity to instruct OSTEOLOGIX not to file, prosecute and/or maintain
any OSTEOLOGIX Patent Right(s) in any country of the Territory. In the event SERVIER instructs
OSTEOLOGIX not to file, prosecute or maintain any OSTEOLOGIX Patent Right(s) in any country such
OSTEOLOGIX Patent Right(s) shall be excluded from the scope of the Agreement, and OSTEOLOGIX shall
have the right to file, prosecute, and maintain any such excluded OSTEOLOGIX Patent Rights at its
own cost.




5.4 Enforcement of OSTEOLOGIX Patent Rights



5.4.1 Notice. If any patent within the OSTEOLOGIX Patent Rights is or might reasonably be
infringed by a Third Party through the manufacture, use, sale, offer for sale, or importation of
any Licensed Product, Compound and/or Combination Product (an “Infringement”), the Party first
having knowledge of such infringement shall promptly notify the other Party in writing. Such
notice shall set forth the facts of the Infringement in reasonable detail.




5.4.2 Enforcement of OSTEOLOGIX Patent Rights.



SERVIER shall have the first right, but not an obligation, to institute, prosecute, under
SERVIER’s control and expenses, using counsel of SERVIER’s choice reasonably acceptable to
OSTEOLOGIX, any action or proceeding with respect to an Infringement in the Territory of a patent
within the OSTEOLOGIX Patent Rights, which, if continued, reasonably would be expected to affect
the manufacture, use, sale, offer for sale, or importation of a Licensed Product and/or Combination
Product.



If SERVIER fails to institute and thereafter prosecute an action or proceeding with respect to
such an Infringement within a period of [***] after the earlier of (i) the date of the Parties’
determination that such infringement, in the Parties’ reasonable judgment, if continued, would
affect materially the manufacture, use, sale, offer for sale, or importation of a Licensed Product
and/or Combination Product, or (ii) the date of OSTEOLOGIX’s request to institute such an action or
proceeding, OSTEOLOGIX shall have the right, but not the obligation, to institute and/or prosecute
and control an action or proceeding in its name with respect to such an Infringement by counsel of
OSTEOLOGIX’s choice.



			
	 	 	 
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In any event, the non-controlling Party agrees to be joined as a party plaintiff if necessary
for the controlling Party to institute and prosecute such action or proceeding, and to give the
controlling Party reasonable assistance and authority to institute and prosecute such action or
proceeding.



However, if the Patent alleged to be infringed is owned by a Third Party and OSTEOLOGIX does
not have authority to require such Third Party to join as a party plaintiff, OSTEOLOGIX agrees to
use Reasonable Efforts to cause such Third Party to agree to be joined as a party plaintiff if
helpful or necessary for SERVIER to prosecute an action or proceeding, and to give SERVIER
reasonable assistance and authority to institute and prosecute such action or proceeding.




5.4.3 Recoveries



Unless otherwise required as a result of prior written agreement, any damages or other
monetary awards recovered in an action or proceeding described above shall be applied first to the
reimbursement of SERVIER and OSTEOLOGIX and, in the circumstance where the Patent infringed is
owned by a Third Party, such Third Party, of such Parties’ respective out-of-pocket expenses
(including without limitation reasonable attorneys’ fees and expenses) actually incurred in
connection with such infringement action or proceeding, on a pro rata basis based upon such
Parties’ respective out-of-pocket expenses, until all such expenses have been recovered. Any
remaining amount of such damages or other monetary awards shall then be applied against obligations
of the Parties in such action or proceeding as a result of written agreements with Third Parties
with respect to the Patent infringed, and then allocated as follows: (1) to the non-controlling
Party, an amount to equal to the remaining amount multiplied by the royalty rate payable by SERVIER
hereunder on Net Sales of Licensed Products (and/or Combination Products) in the jurisdiction
within the Territory in which and at the time such Infringement occurred (“Royalty Amount”), and
(2) to the controlling Party, the remaining amount less the Royalty Amount.



			
	 	 	 
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5.5 Infringement of Third Party Rights.



If a Third Party alleges that the manufacture, use, sale, offer for sale, or importation of
Compounds. Licensed Products and/or Combination Products in the Territory infringes intellectual
property rights owned or otherwise controlled by such Third Party, SERVIER shall have the first
right, but not the obligation, to defend or, after consultation with OSTEOLOGIX
as set forth in this Article 5.5 (Infringement of Third Party Rights), settle any legal action
or proceeding arising from an allegation by a Third Party that the manufacture, use of sale of a
Licensed Product and/or Combination Product in the Territory by a Party infringes a patent owned or
otherwise controlled by such Third Party with respect to any claim. In addition, SERVIER shall have
the right to take appropriate steps to initiate and pursue in the Territory any challenge,
opposition, or other similar actions or proceedings, including without limitation interference
proceedings, relating to a patent application or patent owned or otherwise controlled by a Third
Party with respect to any matter relating to Licensed Products and/or Combination Products.
SERVIER shall promptly disclose to OSTEOLOGIX all material information related to any action or
proceeding, and SERVIER shall consult with OSTEOLOGIX concerning strategy, approaches and the
consequences of approaches to be taken pursuant to this Article 5.5 (Infringement of Third Party
Rights). OSTEOLOGIX shall provide, at SERVIER’s costs, all reasonable assistance requested by
SERVIER in connection with any such action or proceeding. Any and all damages or settlement
amounts obtained from the Third Party shall be for SERVIER.




5.6 Settlement With A Third Party



Except as otherwise expressly provided in Article 5.5 (Infringement of Third Party Rights), a
Party may not settle or otherwise finally resolve an action or proceeding having effects in the
Territory against or by an infringer under Article 5.4 (Recoveries) or Article 5.5 (Infringement
of Third Party Rights) (or Article 5.10 (Joint Improvement Pants) or Article 5.11 (Infringement of
Third Parties’ Intellectual Property Rights)) respectively, without the prior written consent of
the other Party, such consent not to be unreasonably withheld or delayed, but may be withheld if
such settlement would materially and adversely affect the interest of such other Party.




5.7 Trademarks




5.7.1 Ownership



SERVIER shall at its own expense select, register and maintain the trademark(s) used by
SERVIER, its Affiliates, and its Sublicensees (the “SERVIER Trademarks”) in connection with
Licensed Products and/or Combination Products in the Territory. OSTEOLOGIX shall have no rights in
respect of any SERVIER Trademark.



			
	 	 	 
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5.7.2 Notice of Unauthorized Use



OSTEOLOGIX agrees to give SERVIER prompt written notice of any unlicensed use by Third Parties
of SERVIER Trademarks of which OSTEOLOGIX has knowledge.




5.8 Patent Marking



SERVIER (or its Affiliate or Sublicensee) shall mark Licensed Products and/or Combination
Products marketed and sold by SERVIER (or its Affiliate or Sublicensee) hereunder with appropriate
patent numbers or indicia to the extent required by law in those countries in which such notices
affect recoveries of damages or equitable remedies available with respect to infringement of
patents.




5.9 SERVIER Improvement Patents



SERVIER shall have the exclusive right to prosecute, defend, maintain and enforce Patents
claiming SERVIER Improvements (“SERVIER Improvement Patents”).




5.10 Joint Improvement Patents



The Parties shall reasonably agree upon strategies to prosecute, defend and maintain any Joint
Improvement Patents, and, unless otherwise agreed by the Parties, shall share equally all Patent
Costs in connection therewith. Each Party shall provide the other Party all reasonable assistance
and cooperation in the Joint Improvement Patent prosecution efforts, including providing any
necessary powers of attorney and executing any other required documents or instruments for such
prosecution.




5.10.2 Enforcement of Joint Improvement Patents



If any patent within the Joint Improvement Patents is or might reasonably be infringed by a
Third Party through the manufacture, use, sale, offer for sale, or importation of any Licensed
Product, Combination Product, Compound or otherwise, the Party first having knowledge of such
infringement shall promptly notify the other Party in writing. Such notice shall set forth the
facts of the infringement in reasonable detail. SERVIER shall have the first right, but not an
obligation, to institute, prosecute, under SERVIER’s control and expenses, using counsel of
SERVIER’s choice reasonably acceptable to OSTEOLOGIX, any action or proceeding with respect to an
Infringement in the Territory of a patent within the Joint Improvement Patents, which, if
continued, reasonably would be expected to affect the
manufacture, use, sale, offer for sale, or importation of a Licensed Product and/or
Combination Product.



			
	 	 	 
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If SERVIER fails to institute and thereafter prosecute an action or proceeding with respect to
such an Infringement within a period of [***] after the earlier of (i) the date of the Parties’
determination that such infringement, in the Parties’ reasonable judgment, if continued, would
affect materially the manufacture, use, sale, offer for sale, or importation of a Licensed Product
and/or Combination Product, or (ii) the date of OSTEOLOGIX’s request to institute such an action or
proceeding, OSTEOLOGIX shall have the right, but not the obligation, to institute and/or prosecute
and control an action or proceeding in its name with respect to such an Infringement by counsel of
OSTEOLOGIX’s choice.



In any event, the non-controlling Party agrees to be joined as a party plaintiff if necessary
for the controlling Party to institute and prosecute such action or proceeding, and to give the
controlling Party reasonable assistance and authority to institute and prosecute such action or
proceeding.



Unless otherwise required as a result of prior written agreement, any damages or other
monetary awards recovered in an action or proceeding described above shall be applied first to the
reimbursement of SERVIER and OSTEOLOGIX and, in the circumstance where the Patent infringed is
owned by a Third Party, such Third Party, of such Parties’ respective out-of-pocket expenses
(including without limitation reasonable attorneys’ fees and expenses) actually incurred in
connection with such infringement action or proceeding, on a pro rata basis based upon such
Parties’ respective out-of-pocket expenses, until all such expenses have been recovered. Any
remaining amount of such damages or other monetary awards shall then be applied against obligations
of the Parties in such action or proceeding as a result of written agreements with Third Parties
with respect to the Patent infringed, and then allocated as follows: (1) to the non-controlling
Party, an amount to equal to the applicable Royalty Amount, and (2) to the controlling Party, the
remaining amount less the Royalty Amount.




5.11 Infringement of Third Parties’ Intellectual Property Rights



If a Third Party alleges that the practice of any Joint Improvements infringes intellectual
property rights owned or otherwise controlled by such Third Party, the Parties shall reasonably
agree on the measures to take such respect to such allegation.



			
	 	 	 
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ARTICLE 6




CONFIDENTIALITY





6.1 Confidentiality; Exceptions



Except as otherwise provided in this Agreement, the Parties agree that, during the Term and
for [***] years thereafter, all non-public, proprietary or “confidential” marked invention
disclosures, know-how, data, clinical and non-clinical and technical, financial, promotional,
commercial and other information of any nature whatsoever (collectively, “Confidential
Information”), disclosed or submitted, either orally or in writing (including, without limitation
by electronic means) or through observation, by one Party (the “Disclosing Party”) to the other
Party (the “Receiving Party”) hereunder or under the Prior CDA shall be received and maintained by
the Receiving Party in strict confidence, shall not be used for any purpose other than the purposes
expressly permitted by this Agreement, and shall not be disclosed to any Third Party (including
without limitation in connection with any publications, presentations or other disclosures). Each
Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the
Confidential Information. Confidential Information belongs to and shall remain the property of the
Disclosing Party. The provisions of this Article 6 (Confidentiality) shall not apply to any
information that can be shown by the Receiving Party:




	 	6.1.1	 	to have been known to or in the possession of the Receiving
Party prior to the date of its actual receipt from the Disclosing Party;







	 	6.1.2	 	to be or to have become readily available to the public, other
than through any act or omission of the Receiving Party in breach of this
Agreement or any other agreement between the Parties;







	 	6.1.3	 	to have been disclosed to the Receiving Party, other than
under an obligation of confidentiality, by a Third Party which had no
obligation to the Disclosing Party not to disclose such information to others;
or







	 	6.1.4	 	to have been subsequently independently developed by the
Receiving Party without access to or use of the Confidential Information as
demonstrated by competent written records;






provided, however, that the exceptions set forth in Articles 6.1.1, 6.1.3 and 6.1.4 shall not
apply to information pertaining to Joint Improvements or either Party’s Improvements, which shall
be
deemed Confidential Information regardless of whether it satisfies the criteria set forth in one or
both subsections.



			
	 	 	 
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Information pertaining to Joint Improvements shall be deemed the Confidential Information of both
Parties.




6.2 Authorized Disclosure



Notwithstanding the provisions of Article 6.1 (Confidentiality; Exceptions) above and subject
to Articles 6.3 (Confidential Terms) and 6.5 (Publication of Product Information) below, each Party
may use and disclose the other Party’s Confidential Information as follows: (a) under appropriate
confidentiality obligations substantially equivalent to those in this Agreement, to its Affiliates,
licensees, permitted Sublicensees, contractors and any other Third Parties to the extent such use
and/or disclosure is necessary or reasonably useful to perform its obligations or to exercise the
rights granted to it, or reserved by it, under this Agreement (including to grant licenses or
permitted sublicenses hereunder); or (b) to the extent such disclosure is reasonably necessary in
filing or prosecuting intellectual property applications, prosecuting or defending litigation,
complying with Applicable Laws or governmental regulations, obtaining Regulatory Approval,
conducting clinical trials hereunder with respect to a Licensed Product and/or Combination Product,
or submitting information to tax or other Governmental Authorities. If a Party is required by law
or regulations (including securities laws, regulations or guidances) to make any such disclosure of
the other Party’s Confidential Information, to the extent it may legally do so, it will give
reasonable advance notice to the other Party of such disclosure requirement and, save to the extent
inappropriate in the case of patent applications or otherwise, will use its good faith efforts to
secure confidential treatment of such Confidential Information prior to its disclosure (whether
through protective orders or otherwise). For any other disclosures of the other Party’s
Confidential Information, including to Affiliates, licensees, permitted Sublicensees, contractors
and other Third Parties, a Party shall ensure that the recipient thereof is bound by a written
confidentiality agreement as materially protective of such Confidential Information as this Article
6 (Confidentiality).



			
	 	 	 
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6.3 Confidential Terms. Each Party agrees not to disclose to any Third Party the terms of
this Agreement without the prior written consent of the other Party hereto, except each Party may
disclose the terms of this Agreement: (a) to advisors (including financial advisors, attorneys and
accountants), actual or potential acquisition partners or potential investors, and
others on a need to know basis, in each case under appropriate confidentiality provisions
substantially equivalent to those in this Agreement; or (b) to the extent necessary to comply with
applicable laws and court orders (including securities laws, regulations or guidances); provided
that in the case of subsection (b), the disclosing Party shall promptly notify the other Party and
(other than in the case where such disclosure is necessary, in the reasonable opinion of the
disclosing Party’s legal counsel, to comply with securities laws, regulations or guidances) allow
the other Party a reasonable opportunity to oppose with the body initiating the process and, to the
extent allowable by law, to seek limitations on the portion of the Agreement that is required to be
disclosed.




6.4 Return of Confidential Information



The Receiving Party shall keep Confidential Information belonging to the Disclosing Party in
appropriately secure locations. Unless otherwise set forth in this Agreement or as necessary to
exercise its applicable post-termination rights under Article 9.7 (Consequences of Termination),
upon the expiration or termination of this Agreement, any and all Confidential Information
possessed in tangible form by a Receiving Party, its Affiliates, or its Sublicensees, or its or any
of their officers, directors, employees, agents, consultants or clinical investigators and
belonging to the Disclosing Party, shall, upon written request, be immediately returned to the
Disclosing Party (or destroyed if so requested) and not retained by the Receiving Party, its
Affiliates, or its Sublicensees, or any of their officers, directors, employees, agents,
consultants or clinical investigators; provided, however, that a Party may retain one (1) copy of
any Confidential Information in an appropriately secure location, which by Applicable Laws it must
retain, for so long as such Applicable Laws require such retention but thereafter shall dispose of
such retained Confidential Information in accordance with Applicable Laws or this Article 6.4
(Return of Confidential Information).



6.5 Publication of Product Information. Prior to its publishing, publicly presenting and/or
submitting for written or oral publication a manuscript, abstract or the like that includes Data or
other information relating to the Compounds or a Licensed Product or Combination Product generated
under this Agreement that has not previously published pursuant to this Article 6.5 (Publication of
Product Information) (each, a “Publication”), the Party proposing such Publication shall provide
the other Party a copy thereof for its review for at least [***] days unless such Party is required
by law to publish such information sooner. Such Party shall consider in good faith any comments
provided by the other Party during such
period. In addition, the Party proposing such Publication shall, at the request of the other
Party, remove any Confidential Information of the other Party therefrom, except each Party shall
have the right to publicly disclose any information, including Confidential Information, pertaining
to safety of a Licensed Product or Combination Product that such Party believes in good faith it is
obligated to disclose. The contribution of each Party shall be noted in all Publications by
acknowledgment or co-authorship, whichever is appropriate.



			
	 	 	 
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6.6 Press Release. The Parties have agreed to a press release to announce the signing of this
Agreement, and it is set forth in Exhibit D. Neither Party shall make other press releases or
other public statements related to the execution of this Agreement or clinical development
hereunder without the other Party’s prior written approval, which approval shall not be
unreasonably withheld. Notwithstanding the foregoing, each Party consents to references to it in
reports or documents or other disclosures sent to stockholders or filed with or submitted to any
Regulatory Authority or stock exchange or as may be required by law to be made. However, the Party
making such references shall afford the other Party the prior opportunity to review at least [***]
Business Days before the release the text of any such report, document or other disclosure, and
shall comply with any reasonable requests consistent with Applicable Law regarding changes to such
reports, documents and other disclosures which are provided to it by the other Party in a timely
manner. The Parties each agree that once approval for disclosure of information subject to this
Article 6.6 (Press Release) has been obtained, the Party that requested such approval shall be
entitled to use such information substantially in the form initially presented without an
obligation to seek further approval.



ARTICLE 7

REPRESENTATIONS, WARRANTIES AND COVENANTS





7.1 Representations and Warranties of the Parties Concerning Corporate
Authorizations




Each Party represents and warrants to the other Party that:




	 	7.1.1	 	such Party is duly organized and validly existing and in good
standing under the laws of the jurisdiction of its organization;






			
	 	 	 
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	 	7.1.2	 	such Party has the full corporate power and is duly authorized
to enter into, execute and deliver this Agreement, and to carry out and
otherwise perform its obligations thereunder; and







	 	7.1.3	 	this Agreement has been duly executed and delivered by, and is
the legal and valid obligations binding upon such Party and the entry into, the
execution and delivery of, and the carrying out and other performance of its
obligations under this Agreement by such Party (a) does not conflict with, or
contravene or constitute any default under, any agreement, instrument, or
understanding, oral or written, to which it is a party, including without
limitation its certificate of incorporation or by-laws, and (b) does not
violate Applicable Laws or any judgment, injunction, order, or decree of any
Government Authority having jurisdiction over it.







7.2 Representations, Warranties and Covenants of OSTEOLOGIX




OSTEOLOGIX represents, warrants and covenants to SERVIER that:




	 	7.2.1	 	as of the Effective Date, OSTEOLOGIX Controls the OSTEOLOGIX
IP free and clear of any lien, claim, charge, encumbrance or right of any Third
Party in the Territory;







	 	7.2.2	 	OSTEOLOGIX maintains and shall maintain or have maintained
(including without limitation, at OSTEOLOGIX’ option, through engagement of
contractors or consultants) throughout the term of this Agreement a work force
suitably qualified and trained, and facilities and equipment sufficient, to
enable OSTEOLOGIX to perform its obligations as set forth from time to time
under this Agreement;







	 	7.2.3	 	Other than as set forth on Exhibit E, there are not as of the
Effective Date, nor have there been over the five (5) year period immediately
preceding the Effective Date, any claims, lawsuits, arbitrations, legal or
administrative or regulatory proceedings, charges, complaints or investigations
by any Government Authority (except in the ordinary course of the granting of
patents and proceedings relating thereto) or by any Third Party threatening or
(to OSTEOLOGIX’ knowledge) pending
against OSTEOLOGIX or, to OSTEOLOGIX’ knowledge, its licensors relating to
the OSTEOLOGIX Patent Rights;






			
	 	 	 
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	 	7.2.4	 	as of the Effective Date, to OSTEOLOGIX’ knowledge, the
exercise by SERVIER of the rights and licenses granted to SERVIER by OSTEOLOGIX
under this Agreement will not infringe any rights owned or controlled by any
Third Party;







	 	7.2.5	 	as of the Effective Date, OSTEOLOGIX has not granted rights to
any Third Party under the OSTEOLOGIX Patent Rights and the OSTEOLOGIX Know-How
that conflict with the rights granted to SERVIER under this Agreement;







	 	7.2.6	 	OSTEOLOGIX has not used, and during the Term will not use, any
employee or consultant that is debarred by any Governmental Authority or is the
subject of debarment proceedings by any Governmental Authority; provided,
however, that if OSTEOLOGIX learns that its employee or consultant performing
work on its behalf under this Agreement has been debarred by any Governmental
Authority, or has become the subject of debarment proceedings by any
Governmental Authority, OSTEOLOGIX shall promptly notify SERVIER and shall
prohibit such employee or consultant from performing work on OSTEOLOGIX’ behalf
under this Agreement;







	 	7.2.7	 	OSTEOLOGIX covenants to SERVIER that it will comply with all
Applicable Laws, including without limitation any guidance of Governmental
Authorities relating to the development, manufacture promotion and
commercialization of the Licensed Products and Combination Products in each
country outside the Territory; and







	 	7.2.8	 	OSTEOLOGIX will not enter into any agreement with any Third
Party that is in conflict with this Agreement, and will not take any action
that would in any way prevent it from assuming its obligations or granting the
rights granted to SERVIER under this Agreement, or that would otherwise
materially conflict with or adversely affect its obligations or assuming the
rights granted to SERVIER under this Agreement.






			
	 	 	 
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7.3 Representations, Warranties and Covenants of SERVIER




SERVIER represents, warrants and covenants to OSTEOLOGIX that:




	 	7.3.1	 	SERVIER maintains and shall maintain throughout the term of
this Agreement a work force suitably qualified and trained, and facilities and
equipment sufficient, to enable SERVIER to perform its obligations as set forth
from time to time under this Agreement;







	 	7.3.2	 	SERVIER has not used, and during the Term will not use, any
employee or consultant that is debarred by any Governmental Authority or is the
subject of debarment proceedings by any Governmental Authority; provided,
however, that if SERVIER learns that its employee or consultant performing work
on its behalf under this Agreement has been debarred by any Governmental
Authority, or has become the subject of debarment proceedings by any
Governmental Authority, SERVIER shall promptly notify OSTEOLOGIX and shall
prohibit such employee or consultant from performing work on SERVIER’s behalf
under this Agreement;







	 	7.3.3	 	SERVIER covenants to OSTEOLOGIX that it will comply with all
Applicable Laws, including without limitation any guidance of Governmental
Authorities relating to the development, manufacture and commercialization of
the Licensed Products and Combination Products in each country in the
Territory; and







	 	7.3.4	 	SERVIER will not enter into any agreement with any Third Party
that is in conflict with this Agreement, and will not take any action that
would in any way prevent it from assuming its obligations or granting the
rights granted to OSTEOLOGIX under this Agreement, or that would otherwise
materially conflict with or adversely affect its obligations or assuming the
rights granted to OSTEOLOGIX under this Agreement.







7.4 Disclaimer



EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT THE PARTIES MAKE NO REPRESENTATIONS, WARRANTIES OR
COVENANTS OF ANY KIND WHATSOEVER,
WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF
MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.



			
	 	 	 
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ARTICLE 8

INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY





8.1 Indemnification by SERVIER



SERVIER hereby agrees to save, defend, and hold OSTEOLOGIX, its Affiliates and their officers,
directors, employees and agents harmless from and against any and all direct and foreseeable
losses, damages, liabilities, costs and expenses resulting from any claims, demands, actions and
other proceedings by any Third Party (collectively, “Losses”) to the extent resulting directly from
or arising directly out of [***].




8.2 Indemnification by OSTEOLOGIX



OSTEOLOGIX hereby agrees to save, defend and hold SERVIER, its Affiliates and their officers,
directors, employees and agents harmless from and against any and all Losses to the extent
resulting directly from or arising directly out of [***].




8.3 Control of Defense



In the event a Party seeks indemnification under Article 8.1 (Indemnification by SERVIER),
Article 8.2 (Indemnification by OSTEOLOGIX) [***], it shall inform the other Party (the
“Indemnifying Party”) of a claim as soon as reasonably practicable after it receives notice of the
claim, shall permit the Indemnifying Party to assume direction and control of the defense of the
claim (including the right to settle the claim solely for monetary consideration and with an
unconditional release of claims against the indemnitee), and shall cooperate as requested (at the
expense of the Indemnifying Party) in the defense of the claim. The indemnitee shall be entitled to
participate, at its own expense and with its own counsel, in the defense of any indemnified claim
and the Indemnifying Party shall not settle or compromise any such matter in any manner which would
have an adverse effect upon the indemnitee without such indemnitee’s consent, which shall not be
unreasonably withheld or delayed. In addition, if the Indemnifying Party believes that it is not
obligated to provide indemnity as to a matter as to which it is requested to do so by an indemnitee
and promptly so notifies the indemnitee, the indemnitee may either take action to enforce its
rights hereunder or assume the
defense of such claim with its own counsel at its own expense, provided that the Indemnifying
Party will be responsible for the payment of such expenses if it is ultimately determined such
indemnitee was entitled to indemnification hereby.



			
	 	 	 
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8.4 Mitigation



For the avoidance of doubt no Party shall recover from the other Party more than once for a
single cause of action under an indemnity granted by an Indemnifying Party pursuant to this
Agreement or recover if or to the extent the indemnitee has been relieved by or recovered from any
Third Party. Each Party shall take and shall cause its Affiliates to take all reasonable steps to
mitigate any Losses upon becoming aware of any event which would reasonably be expected to, or
does, give rise thereto, including incurring costs only to the minimum extent necessary to remedy a
breach that gives rise to the Losses.




8.5 Insurance



SERVIER Responsibilities. For so long as SERVIER (or any of its Affiliates or Sublicensees)
is conducting clinical trials using any Compound or any Licensed Product or Combination Product, or
manufacturing, marketing, promoting, distributing or selling any Licensed Product or Combination
Product, as applicable, under this Agreement and for the post-termination period set forth below,
SERVIER shall either provide reasonably satisfactory evidence to OSTEOLOGIX of SERVIER’s
self-insurance covering its activities and obligations hereunder or obtain product liability
insurance for the benefit of SERVIER, covering such activities and obligations under terms that are
similar to those obtained by SERVIER for SERVIER’s other similar products under development and
other similar products being manufactured, marketed, promoted, distributed or sold. Such insurance
shall be maintained throughout the duration of the Agreement and for five years after termination
or expiration of this Agreement.



			
	 	 	 
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OSTEOLOGIX Responsibilities. As of the Effective Date, OSTEOLOGIX shall obtain and maintain
commercial general liability insurance (including product liability and contractual liability
insurance applicable to OSTEOLOGIX’ indemnity obligations hereunder) with reputable and financially
secure insurance carriers to cover OSTEOLOGIX’ activities and obligations under this Agreement.
Such insurance shall be maintained throughout the duration of the Agreement.




8.6 Limitation of Liability




	 	8.6.1	 	Limitation of Liability. EXCEPT FOR EACH PARTY’S
INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 8.1 (INDEMNIFICATION BY SERVIER) OR
ARTICLE 8.2 (INDEMNIFICATION BY OSTEOLOGIX), AS APPLICABLE, AND ANY CLAIMS
RELATED TO ONE PARTY’S INFRINGEMENT OF THE OTHER PARTY’S INTELLECTUAL PROPERTY
OUTSIDE OF THE RIGHTS AND LICENSES GRANTED UNDER ARTICLE 4 (LICENSES) OR BREACH
BY A PARTY OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER, UNDER NO CIRCUMSTANCES
SHALL A PARTY HEREOF BE LIABLE TO THE OTHER PARTY HEREOF FOR CONSEQUENTIAL,
INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES.






ARTICLE 9

TERM AND TERMINATION





9.1 Term.




	 	9.1.1	 	Expiration. This Agreement shall commence on the Effective
Date and shall remain in full force and effect for so long as SERVIER is
obligated to pay royalties on sales of Licensed Products (or Combination
Products) in any country in the Territory or Sublicensing Revenue in Japan (the
“Term”).







	 	9.1.2	 	Notwithstanding the provisions of Article 9.1.1 (Expiration),
this Agreement may be terminated, in whole or in part, prior to expiration of
the Term pursuant to the terms and conditions of Articles 9.2 (Termination for
Safety and/or Public Health Issues), 9.3 (Termination
for Cause), 9.4 (Termination for Insolvency), 9.5 (Termination at Will) and
9.6 (Termination Related to OSTEOLOGIX Patent Right(s)).






			
	 	 	 
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9.2 Termination for Safety and/or Public Health Issues



SERVIER shall be entitled to terminate this Agreement immediately upon written notice to
OSTEOLOGIX in the event of the occurrence or likely occurrence of events adversely affecting the
safety and/or public health status of the Compound and/or Licensed Product.




9.3 Termination for Cause



If either Party commits a material breach of this Agreement at any time, which breach is not
cured within thirty (30) days after written notice from the non-breaching Party specifying the
breach, or if such breach is not susceptible of cure within such period, the non-breaching Party
shall have the right to terminate this Agreement by written notice on a country-by-country and
Licensed Product-by-Licensed Product basis. The Parties acknowledge and agree that failure to
exercise any right or option, or to take any action expressly within the discretion of a Party
shall not be deemed to be a material breach hereunder.




9.4 Termination for Insolvency



To the extent permitted by Applicable Laws, either Party may terminate this Agreement upon
written notice to the other Party on or after the occurrence of any of the following events: (a)
the appointment of a trustee, receiver or custodian for all or substantially all of the property of
the other Party, or for any lesser portion of such property, if the result materially and adversely
affects the ability of the other Party to fulfill its obligations hereunder, which appointment is
not dismissed within [***], (b) the determination by a court or tribunal of competent jurisdiction
that the other Party is insolvent such that the other Party’s liabilities exceed the fair market
value of its assets, (c) the filing of a petition for relief in bankruptcy by the other Party on
its own behalf, or the filing of any such petition against the other Party if the proceeding is not
dismissed or withdrawn within [***] thereafter, (d) an assignment by the other Party for the
benefit of creditors, or (e) the dissolution or liquidation of the other Party. All rights and
licenses granted under or pursuant to this Agreement by one Party to the other Party are, and shall
otherwise be deemed to be, licenses of rights to “intellectual property”. The Parties agree that
both Parties, as licensees of such rights and licenses, shall retain and may fully exercise all of
their rights and elections under Applicable Laws.



			
	 	 	 
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9.5 Termination at Will



At any time following the payment by SERVIER of the three million Euros due on March
31st, 2013, SERVIER shall have the right to terminate this Agreement upon not less than
thirty (30) days prior written notice thereof to OSTEOLOGIX, with consequences as set forth in
Article 9.7.3 (Termination by SERVIER on the Basis of Article 9.5).




9.6 Termination Related to OSTEOLOGIX Patent Right(s)




[***]




9.7 Consequences of Termination




9.7.1 Termination by SERVIER on the Basis of Article 9.2



If SERVIER terminates the Agreement on the basis of Article 9.2 (Termination for Safety and/or
Public Health Issues), SERVIER shall pay to OSTEOLOGIX the license fee described in Article 3.1
(License Fee), the milestone payments described in Article 3.3 (Milestone Payments) (to the extent
not already paid and whether or not due), and any outstanding Minimum Payment due on the date
termination takes effect to the extent those sums were not already paid to OSTEOLOGIX. Such payment
shall be due within thirty (30) calendar days of SERVIER’s written notice of termination.




9.7.2 Termination by OSTEOLOGIX on the Basis of Article 9.3



If OSTEOLOGIX terminates the agreement on the basis of Article 9.3 (Termination for Cause), SERVIER
(or its Affiliates, or Sublicensees, as applicable) will assign to OSTEOLOGIX all of such party’s
right, title and interest to any Regulatory Approvals, Approval Applications, inventory (at costs),
directly related to the Licensed Product or any Combination Product, contract rights (including
without limitation rights under its agreements with Sublicensees), rights of reference (but
excluding the SERVIER IP and Servier Data, their use by OSTEOLOGIX being determined solely by the
terms of Articles 2.2 (Exchange of Data) [***], and excluding SERVIER’s interest in the Joint
Improvements and Joint Improvement Patents). In event of such a termination, SERVIER’s obligations
under Article 4.5.1 (but not OSTEOLOGIX’s obligations under Article 4.5.2) shall survive and
continue in full force and effect in accordance with the terms of Article 4.5.1.



			
	 	 	 
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9.7.3 Termination by SERVIER on the Basis of Article 9.5



If SERVIER terminates the agreement on the basis of Article 9.5 (Termination at Will):





(a) before having filed for Regulatory Approval of the Licensed Product by the EMA, [***]



(b) after having filed for Regulatory Approval of the Licensed Product by the EMA and having
such Regulatory Approval finally denied [***];



and




(c) [***], and excluding SERVIER’s interest in the Joint Improvements and Joint Improvement
Patents).




9.7.4 Termination by SERVIER on the basis of Article 9.3.



(a) In the event OSTEOLOGIX commits a material breach of this Agreement and such breach has or
is reasonably expected to have a material adverse effect on SERVIER’s activities relating to the
Compound and/or Licensed Product as contemplated under the Agreement, and SERVIER terminates this
Agreement (in its entirety) on the basis of Article 9.3 (Termination for Cause) for such material
breach, SERVIER shall have a perpetual, fully paid-up, royalty-free, exclusive license, which
includes the right to sublicense, under OSTEOLOGIX IP to make, have made, use, promote, market,
sell, offer for sale, import, export and otherwise commercialize the Licensed Product and
Combination Products in the Territory.



(b) In the event OSTEOLOGIX commits a material breach of this Agreement and such breach has
not or is not reasonably expected to have a material adverse effect on SERVIER’s activities
relating to the Compound and/or Licensed Product as contemplated under the Agreement, and SERVIER
terminates this Agreement (in its entirety) on the basis of Article 9.3 (Termination for Cause) for
such material breach, the licenses granted to SERVIER in Article 4 (Licenses) shall survive,
provided that SERVIER continues to pay applicable royalties and milestone payments [***] as set
forth in Article 3 (Financial Terms).



			
	 	 	 
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(c) Upon termination as provided in (a) or (b) above, all of the provisions of this Agreement
shall continue in full force and effect in accordance with their terms (subject to further
termination under this Article 9 (Term and Termination), and except as modified pursuant to (a) and
(b) above), except for (i) SERVIER’s obligations to share and discuss its Development Plan and
Commercialization Plan under Article 2 (Development, Registration, Supply and Commercialization),
participate in meetings and provide any report to
OSTEOLOGIX under Article 2 (Development, Registration, Supply and Commercialization), (ii) the
ongoing exchange of Data and other information and materials in Article 2.2 (Exchange of Data)
(other than for pharmacovigilance purposes), (iii) both Parties’ obligations under Article 4.5.1
(Competitive Compounds), (iv) SERVIER’s obligations to use Reasonable Efforts to commercialize the
Licensed Products and (v) [***]). Upon such a termination, all references to the Term in the
surviving sections of this Agreement (e.g., in Article 6.1 (Confidentiality; Exceptions)) shall be
deemed to include to continue until the time it would otherwise have expired if SERIVER had not so
terminated this Agreement.




9.7.5 Termination by SERVIER on the basis of Article 9.6.




[***]




9.7.6 Return of Materials



Unless otherwise set forth in this Agreement or as necessary to exercise its applicable
post-termination rights, upon termination of this Agreement, the receiving Party shall destroy all
Confidential Information it has received from the disclosing Party or on the latter’s behalf, that
is in the receiving Party’s possession, and provide written certification of such destruction, or
prepare such Confidential Information for shipment to disclosing Party, as the disclosing Party may
direct, at disclosing Party’s expense.




9.7.7 Accrued Rights



Termination, relinquishment or expiration of this Agreement for any reason shall be without
prejudice to any right which shall have accrued to the benefit of either Party prior to such
termination, relinquishment or expiration, including damages arising from any breach under this
Agreement. Such termination, relinquishment or expiration shall not relieve either Party from
obligations which are expressly indicated to survive termination or expiration of this Agreement.



			
	 	 	 
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9.7.8 Survival



The following articles and sections of this Agreement shall survive expiration of this
Agreement pursuant to Article 9.1.1 (Expiration) or termination of this Agreement for any reason:
all definitions, Article 2.2 (with respect to use of Data for pharmacoviligance purposes,
OSTEOLOGIX’s clinical trial rights, and [***]), Article 2.6 (Pharmacoviligance; Exchange of Safety
Information and Quality Issues), Article 2.7 (Reports; Inspection) [***], Article 2.8
(Regulatory Inspections) [***], Article 2.9 (Audit Rights) [***], any due but unpaid payment
obligations, Article 3.9 (Records and Audit) [***], Article 3.10 (Taxes and Withholding), Article
3.11 (Currency), Article 3.12 (Payments; Late Payments), Article 4.6 (Retained Rights; No Implied
License), Article 5.1 (Ownership of Intellectual Property and Challenge) (other than Article
5.1.4), Article 5.4 (Enforcement of OSTEOLOGIX Patent Rights) (with respect to proceedings ongoing
at the time of termination), Article 5.6 (Settlement with a Third Party), Article 5.10 (Joint
Improvement Patents), Article 6 (Confidentiality) (in accordance with its terms), Article 8
(Indemnification, Insurance, Limitation of Liability), Article 9.7 (Consequences of termination),
Article 10 (Governing Law and Dispute Resolution), Article 11.1 (Assignment; Subcontracting),
Article 11.2 (Change of Control) (with respect to termination consequences), and Articles 11.3
(Force Majeure) through 11.15 (Counterparts).



However, the foregoing shall not affect the survival or termination of the provisions of this
Agreement as described elsewhere in this Article 9.7 (Consequences of Termination) with respect to
specific termination scenarios (and, to the extent of any conflict between the preceding paragraph
and the other subsections of this Article 9.7 (Consequences of Termination), such other subsections
shall prevail).



ARTICLE 10

GOVERNING LAW AND DISPUTE RESOLUTION





10.1 Governing Law



This Agreement shall be governed by and construed under the laws of the Republic of Ireland,
without giving effect to any conflicts of law principle that would result in the application of the
laws of any jurisdiction other than the Republic of Ireland.




10.2 Dispute Resolution



10.2.1 If, at the time of any dispute, the Parties are otherwise unable to resolve a dispute
arising out of or in connection with this Agreement informally, either SERVIER or OSTEOLOGIX by
written notice to the other, may have such dispute referred to Responsible Executives, one from
each of the Parties, designated to resolve such a dispute by good faith negotiations.



			
	 	 	 
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10.2.2 Any dispute that has not been resolved in accordance with Article 10.2.1 shall be
submitted to the Responsible Executives no later than [***] days after such request by
either SERVIER or OSTEOLOGIX. If Responsible Executives of the Parties are unable to resolve
any such dispute, such dispute will be submitted to arbitration. Any such arbitration shall be
governed by and finally settled under the Rules of Arbitration of the International Chamber of
Commerce by one or more arbitrators appointed in accordance with the said Rules. The arbitration
proceedings shall take place in Dublin, Ireland in the English language.



10.2.3 All negotiations conducted by the Parties pursuant to this Article 10.2 (Dispute
Resolution) shall be deemed to be and shall be treated as compromise and settlement negotiations.
Nothing said or disclosed, nor any document produced, in the course of such negotiations which is
not otherwise independently discoverable shall be offered or received as evidence or used for
impeachment or for any other purpose in any current or future arbitration or litigation.



10.2.4 Nothing in this Article 10.2 (Dispute Resolution) shall be deemed as preventing either
Party from seeking injunctive relief (or any other provisional remedy) from any court having
jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either
Party’s name, Confidential Information or intellectual property, or from submitting any dispute
relating to the scope, validity, enforceability or other like matter regarding intellectual
property to any court having jurisdiction over the Parties and the subject matter of the dispute
and to seek such relief and remedies as are available in that court. In such an event, the Parties
shall invoke the provisions of this Article 10.2 (Dispute Resolution) in parallel.



ARTICLE 11

GENERAL PROVISIONS





11.1 Assignment; Subcontracting



Neither Party may assign or otherwise transfer its rights or obligations under this Agreement
without the prior written consent of the other Party, such consent not to be unreasonably withheld,
except that (a) a Party may assign or otherwise transfer its rights or obligations in whole or in
part without such consent to an Affiliate of such Party, provided that no such assignment shall
relieve any Party as the primary obligor hereunder and each Party shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such performance (including Article
6 (Confidentiality)); (b) OSTEOLOGIX may assign this Agreement and its



			
	 	 	 
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rights and obligations
hereunder in connection with a merger, consolidation, reorganization, or a sale of all or substantially all of its assets to which this Agreement
relates; and (c) OSTEOLOGIX may assign this Agreement (in whole or in part) in connection with
obtaining financing, monetizing or transferring the stream payments due OSTEOLOGIX under this
Agreement, provided in the event of (a) or (c) above, the assignor and the assignee shall be
jointly and severally liable towards the other Party for their performance under this Agreement.
This Agreement shall be binding upon and inure to the benefit of the successors and permitted
assigns of the Parties. Any assignment not in accordance with this Agreement shall be null, void,
and of no effect. Each Party may subcontract its rights or obligations under this Agreement without
the prior written consent of the other Party.




11.2 Change of Control



[***]



In addition, such change of control of OSTEOLOGIX shall be treated as the expiration or termination
of the Agreement for the purposes of Article 6.4 (Return of Confidential Information) above with
respect to Confidential Information of SERVIER in OSTEOLOGIX’s possession.



Notwithstanding anything in this Agreement to the contrary, in the case of a change of control of
OSTEOLOGIX (or assignment of this Agreement by OSTEOLOGIX as described in subsection (b) of Article
11.1(Assignment; Subcontracting)), such transaction shall not cause SERVIER or its Affiliates to
have rights or access to intellectual property or technology of the acquirer or merger partner of
OSTEOLOGIX (other than the OSTEOLOGIX Patent Rights and OSTEOLOGIX Know-How licensed to SERVIER
hereunder as of the effective date of such transaction).



			
	 	 	 
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11.3 Force Majeure



Neither Party shall lose any rights hereunder or be liable to the other Party for damages or
losses on account of failure of performance by the defaulting Party if the failure is occasioned by
government action (not specifically directed at such Party), war, fire, explosion, flood, external
strike, lockout, embargo, act of God, or any other similar cause beyond the control of the
defaulting Party, provided that the Party claiming force majeure shall promptly notify the other
Party in writing setting forth the nature of such force majeure, shall use reasonable efforts to
eliminate, remedy or overcome such force majeure event and shall resume performance of its
obligations hereunder as soon as reasonably practicable after such force majeure ceases. If any
force majeure event continues for more than [***], the other Party may terminate this Agreement in
part, on a country-by-country basis, or in whole, if all countries are affected, upon written
notice to the affected Party.




11.4 Further Actions



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




11.5 Governmental Approvals; Compliance With Law



The Parties shall make all filings with Government Authorities as shall be required by
Applicable Laws in connection with this Agreement and the activities contemplated hereunder or
thereunder. In fulfilling its obligations under this Agreement each Party agrees to comply in all
material respects with all Applicable Laws.




11.6 Notices



All notices required or permitted to be given under this Agreement, including, without
limitation all invoices provided by OSTEOLOGIX to SERVIER, shall be in writing and shall be deemed
given if delivered personally or by facsimile transmission receipt verified, mailed by registered
or certified mail return receipt requested, postage prepaid, or sent by express courier service, to
the Parties at the following addresses, or at such other address for a Party as shall be specified
by like notice, provided that notices of a change of address shall be effective only upon receipt
thereof.



			
	 	 	 
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	If to OSTEOLOGIX, addressed to:

	 	OSTEOLOGIX
	 

	 	Fax:
	 

	 	Attention:
	 
	 	 
	If to SERVIER addressed to:

	 	Institut de Recherche International SERVIER
	 

	 	6, place des Pléiades
	 

	 	92415 Courbevoie, France
	 

	 	[***]
	 

	 	[***]
	 

	 	[***]
	 
	 	 
	With a copy (except for invoices) to:
	 	 
	 

	 	Les Laboratoires SERVIER

22 rue Garnier
	
	 	92200 Neuilly sur Seine, France
	 

	 	To the attention of the Legal Department






The date of receipt of any notice given under this Agreement, including, without limitation any
invoice provided by OSTEOLOGIX to SERVIER, shall be deemed to be (a) the date given if delivered
personally or by facsimile transmission receipt verified, (b) [***] days after the date mailed if
mailed by registered or certified mail return receipt requested, postage prepaid, or (c) [***] days
after the date sent if sent by express courier service.




11.7 Waiver



No failure of either Party to exercise and no delay in exercising any right, power or remedy
in connection with this Agreement will operate as a waiver thereof, nor will any single or partial
exercise of any right, power or remedy preclude any other or further exercise of such right, power
or remedy or the exercise of any other right, power or remedy.




11.8 Disclaimer of Agency



The relationship between OSTEOLOGIX and SERVIER established by this Agreement is that of
independent contractors, and nothing contained herein shall be construed to (a) give either Party
the power to direct or control the day-to-day activities of the other, (b) constitute the Parties
as the legal representative or agent of the other Party or as partners, joint ventures, co-owners
or otherwise as participants in a joint or common undertaking, or (c) allow either Party to create
or assume any liability or obligation of any kind, express or implied, against or in the name of or
on behalf of the other Party for any purpose whatsoever.



			
	 	 	 
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11.9 Ambiguities



Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective
of which Party may be deemed to have authored the ambiguous provision.




11.10 Headings and Section References



The article and section headings and references contained herein are for the purposes of
convenience only and are not intended to define or limit the contents of said articles or sections,
except that any conflict between an article or section reference number and any textual reference
to the article or section title noted next to such reference, will resolved in favor of the textual
reference.




11.11 Severability



If any provision of this Agreement or the application thereof to any Party or circumstance
shall, to any extent, be held to be invalid or unenforceable by a court or administrative agency of
competent jurisdiction, then (a) the remainder of such provision, or the application of such
provision to Parties or circumstances other than those as to which it is held invalid or
unenforceable, shall not be affected thereby and each provision shall be valid and be enforced to
the fullest extent permitted by law; and (b) the Parties hereto agree to renegotiate any such
provision thereof in good faith in order to provide a reasonably acceptable alternative to the
provision that is invalid or unenforceable, it being the intent of the Parties that the basic
purposes of this Agreement are to be effectuated.




11.12 Maintenance of Records



Each Party will keep and maintain all records required by Applicable Laws with respect to
Licensed Products and/or Combination Products and will make copies of such records available to the
other Party upon request.




11.13 Entire Agreement



This Agreement, including all exhibits attached hereto, which are hereby incorporated herein
by reference, sets forth all covenants, promises, agreements, warranties, representations,
conditions and understandings between the Parties hereto and supersedes and terminates all prior
and contemporaneous agreements and understandings between the Parties with respect to the subject
matter hereof, including the Prior CDA. There are no covenants, promises,
agreements, warranties, representations, conditions or understandings, either oral or written,
between the Parties other than as set forth herein. No subsequent alteration, amendment, change or
addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and
signed by the respective authorized officers of the Parties.



			
	 	 	 
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11.14 Use of Names



Except as otherwise provided herein or as required by applicable law, regulation or court
order, no right, express or implied, is granted to either Party by this Agreement to use in any
manner any trademark, trade name or logo of the other Party, including without limitation the names
“SERVIER” and “OSTEOLOGIX”, without the prior written consent of the owning Party.




11.15 Counterparts



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



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In Witness Whereof, the Parties have executed this Agreement by their proper officers as of
the Effective Date.



	 	 	 	 	 	 	 
	OSTEOLOGIX LIMITED	 	Les Laboratoires SERVIER
	(“OSTEOLOGIX”)	 	(“SERVIER”)
	 
	 	 	 	 	 	 
	By:

	 	By:	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	[***]
	 
	 	 	 	 	 	 
	Director	 	Proxy
	 
	 	 	 	 	 	 
	 

	 	By:	 	 	 	 
	 
	 	 	 	 	 
	 	 	[***]
	 
	 	 	 	 	 	 
	 	 	Proxy
	 
	 	 	 	 	 	 
	 	 	Institut de Recherches
	 	 	Internationales SERVIER
	 
	 	 	 	 	 	 
	 

	 	By :	 	 	 	 
	 

	 	 	 	 

	 	 
	 	 	[***]
	 	 	[***]






			
	 	 	 
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EXHIBIT A




OSTEOLOGIX PATENT RIGHTS




[***]



			
	 	 	 
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EXHIBIT B




OSTEOLOGIX PATENT RIGHTS




[***]



			
	 	 	 
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EXHIBIT C




[***]



			
	 	 	 
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EXHIBIT D




Press Release




			
	 	 	 
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EXHIBIT E




[***]



			
	 	 	 
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