Exhibit 10.1

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

EXECUTION VERSION

LICENSE AGREEMENT

This Agreement is made and entered into on August 5, 2009 (the “Effective Date”)
by and

Between

DEBIOPHARM S.A., a Swiss corporation having its principal place of business at
Forum «après-demain», Chemin Messidor 5-7, 1006 Lausanne, Switzerland
(“Debiopharm”),

On the one hand,

And

CURIS, INC., a corporation established under the laws of the State of Delaware,
USA, having its principal place of business at 45 Moulton Street, Cambridge, MA
02138, United States of America (“Curis”),

On the other hand;

WITNESSETH:

WHEREAS, Debiopharm is a pharmaceutical company active in the research and
development, the registration and the commercialization of pharmaceutical
products, as well as in the acquisition and granting of licenses and other
proprietary rights related to such products;

WHEREAS, Curis is a drug development company developing innovative signaling
pathway drug technologies to seek to create new medicines, primarily in the
field of oncology;

WHEREAS, Curis wishes to license out to Debiopharm all the proprietary rights in
and to the compound known as “CUDC-305”;

WHEREAS, Debiopharm wishes to obtain from Curis a license to such compound known
as “CUDC-305” in order to develop, manufacture and commercialize Products (as
hereinafter defined);

WHEREAS, both Debiopharm and Curis wish to enter into this Agreement which
provides Debiopharm with an exclusive license to the Compound (as hereinafter
defined) to develop and commercialize Products (as hereinafter defined) in the
Field of Use (as hereinafter defined) and in the Territory (as hereinafter
defined), under the terms and conditions set forth below;

NOW, THEREFORE, in consideration of the foregoing and the covenants and
obligations set forth in this Agreement, Debiopharm and Curis agree as follows:

 

1 DEFINITIONS AND INTERPRETATIONS

Terms, when used with initial capital letters, shall have the meanings set forth
below or at their first use when used in this Agreement:

 

“Affiliate(s)”:    shall mean any corporation or other business entity
controlled by, controlling, or under common control with or by Debiopharm or

 

 

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   Curis. For this purpose, “control” means direct or indirect beneficial
ownership of at least fifty percent (50%) of the voting stock of a corporation
or other business entity. “Agreement”:    shall mean this license agreement.
“API”:    shall mean an active pharmaceutical ingredient. “Backup Compound(s)”:
   shall mean all Hsp90 Inhibitors [**], as well as their prodrugs and
metabolites, and all isomers, esters, salts, hydrates, solvates, and polymorphs
thereof. “Change of Control Transaction”:    shall have the meaning ascribed to
this term in paragraph (a) of Article 19. “Combination Product”:    shall mean a
Product combining a Compound together with another API. “Compound”:    shall
mean CUDC-305 as described in Exhibit 1, any prodrug or metabolite of CUDC-305,
any isomer, ester, salt, hydrate, solvate, or polymorph of CUDC-305, including
any Backup Compound. “Confidential Information”:    shall mean any information
of a confidential or proprietary nature disclosed by a Party or its Affiliates
(the “Disclosing Party”) to the other Party or its Affiliates (the “Receiving
Party”), including, but not limited to, each Party’s or its Affiliates’
invention disclosures, proprietary materials, data, know-how, technologies,
trade secrets, and/or manufacturing, marketing, personnel and other business
information and plans (including, without limitation, the opinions and advice of
each Party’s respective in-house and outside counsel with respect to
intellectual property matters), whether in oral, written, graphic or electronic
form. Information shall not be deemed “Confidential Information” hereunder, and
the Receiving Party shall have no obligation with respect to any information
that the Receiving Party can demonstrate by competent evidence:   

(i)     

   is known by the Receiving Party prior to disclosure by the Disclosing Party,
as evidenced by internal records or documentation of the Receiving Party; or   
(ii)    is in the public domain or subsequently enters the public domain without
any breach of this Agreement by the Receiving Party; or    (iii)    is received
by the Receiving Party from an independent Third Party with the lawful right to
disclose; or    (iv)    was independently developed by the Receiving Party (or
its Affiliates’) employees or contractors without the use of or reference to
Confidential Information of the Disclosing Party, as evidenced by the Receiving
Party’s written records.

 

 

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“Control” or “Controlled”:    shall mean, with respect to any information,
patent rights or other intellectual property rights, possession by an entity of
the ability (whether by ownership, license or otherwise) to grant access to, to
grant use of, or to grant a license or a sublicense of or under such
information, patent rights or intellectual property rights. “CTA”:    shall mean
a clinical trial application. “Curis Intellectual Property Rights”:    shall
mean all Curis Patents and Curis Know-How. “Curis Know-How”:    shall mean any
and all technical information, test and development data and results,
formulations, processes, ideas, protocols, regulatory files, pre-clinical and
clinical data (including, without limitation, Data) and the like relating to the
use or development of the Compound or the Product in the Field of Use, which is
conceived, reduced to practice and Controlled by Curis: (a) on or prior to the
Effective Date; (b) during the six- (6-) month period following the Effective
Date; (c) [**]; (d) in the course of Curis’ participation on the JSC; (e) in the
course of any preclinical studies undertaken by Curis in accordance with Section
3.1.3, and (f) as the need arises and as may be mutually agreed by the Parties
after the Effective Date, during the Term; and which, in each case, is provided
to Debiopharm under this Agreement. “Curis Patent(s)”:    shall mean any and all
of the patents and patent applications Controlled by Curis or its Affiliates
(which, for purposes of this definition, shall be limited to Affiliates that are
controlled by Curis within the meaning of the definition of Affiliate) on the
Effective Date and during the Term, that claim the manufacture, use, sale, offer
for sale or import of the Compound or the Product as specified in Exhibit 2,
together with any and all patents issued on any such applications as well as any
divisional, continuation, continuation-in-part to the extent that claims are
directed toward the subject matter specifically described in patent applications
listed in Exhibit 2, substitution applications, re-issue, re-examination,
renewal and extended patents (including supplementary protection certificates
(SPC)) of any of the foregoing. Curis Patents shall exclude the Joint Patents.
“Data”:    shall mean any and all scientific and research data, technical data,
test and development data, pre-clinical and clinical data (including
pharmacological, biological, chemical, biochemical, toxicological, pre-clinical
and clinical test data, analytical and quality control data, stability data,
results of studies, patient lists), formulations, processes, protocols,
regulatory files and the like which are developed by either Party in connection
with the Compound or the Product.

 

 

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“Debiopharm Intellectual Property Rights”:    shall mean all Debiopharm Patents
and Debiopharm Know-How. “Debiopharm Know-How”:    shall mean any and all
technical information, test and development data and results, formulations,
processes, ideas, protocols, regulatory files, preclinical and clinical data
(including, without limitation, Data) and the like relating to the use or
development of the Compound or the Product, which is secret, non-patented and
which is conceived or reduced to practice by Debiopharm (or third parties which
will have assigned such know-how to Debiopharm) during the Term. “Debiopharm
Patent(s)”:    shall mean any and all patents and patent applications for any
invention relating to the use of the Compound, the Product, or any process which
uses the Compound or the Product, conceived and reduced to practice by
Debiopharm (or third parties which will have assigned their rights to
Debiopharm) during the Term, that claim the manufacture, use, sale, offer for
sale or import of the Compound or the Product, together with any and all patents
issued on any such applications as well as any divisional, continuation,
continuation-in-part, substitution applications, re-issue, re-examination,
renewal and extended patents (including supplementary protection certificates
(SPC)) of any of the foregoing. “Development Plan”:    shall mean plans for
development of Products as outlined in Exhibit 3. “EMEA”:    shall mean the
European Medicines Agency, or any successor agency thereto. “FDA”:    shall mean
the United States Food and Drug Administration, or a successor federal agency
thereto. “Field of Use”:    shall mean the use of Products in all human and
veterinary fields. “First Commercial Sale”:    shall mean the first commercial
sale by Debiopharm, its Affiliates and/or Sublicensees to a Third Party of a
Product for value in any country in the Territory following receipt of approval
to market such Product from the relevant Regulatory Authority in the applicable
country. “Generic Product”:    shall mean, with respect to a Product in a given
country, a product being sold by Third Party(ies) in such country that (a) has
received marketing approval from the applicable Regulatory Authority in such
country, (b) contains the same API as the Compound contained in such Product,
and (c) is not covered by a valid Curis Patent or Joint Patent in such country.

 

 

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“Hsp90 Inhibitor”:    shall mean a compound that binds to, and selectively and
specifically inhibits, Hsp90. “IND”:    shall mean an “Investigational New Drug”
application – i.e., an application filed with the FDA and any application filed
with any other Regulatory Authorities to obtain permission to commence human
clinical trials for a pharmaceutical product in a country or group of countries.
“IND/CTA Approval Milestone”:    shall have the meaning ascribed to this term in
Section 6.3. “IND/CTA Filing Conditions”:    shall have the meaning ascribed to
this term in Section 3.2.5(a). “IND/CTA Filing Deadline”:    shall have the
meaning ascribed to this term in Section 3.2.5(a). “Indication”:    means any
indication for which (a) a Product is developed pursuant to an IND or CTA (or if
no such filing is required, pursuant to the applicable clinical trial protocol),
(b) an NDA for a Product is submitted, or (c) an NDA for a Product is approved
by a Regulatory Authority. Any distinct Indication must include new clinical
trial data. Any change in tumor type is considered as a new Indication. For
instance, the passage from ovarian cancer to breast cancer is considered as a
new Indication. However a change in the line of treatment or a passage from
metastatic to adjuvant setting within the same tumor type will not be considered
as a new Indication. For instance, the indication metastatic Colo-Rectal Cancer
(CRC) replacing second line metastatic CRC is not a new Indication. Also the
addition of adjuvant treatment of CRC is not considered as a new Indication in
this example. Variations such as change in regimen or combination with other
anticancer drugs or change in formulation within the same tumor type are also
not considered as a new Indication. “Inventions”:    shall have the meaning
ascribed to this term in Section 7.1.2. “Joint Inventions”:    shall have the
meaning ascribed to this term in Section 7.1.2. “Joint Patents”:    shall mean
any and all patents and patent applications claiming any Joint Invention,
together with any and all patents issued on any such applications as well as any
divisional, continuation, continuation-in-part, substitution applications,
re-issue, re-examination, renewal and extended patents (including supplementary
protection certificates (SPC)) of any of the foregoing. “JSC”:    shall mean the
joint steering committee created by the Parties according to Section 4.1.

 

 

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“Major Market(s)”:    shall mean any of the following countries or groups of
countries:    (i)    the United States of America;    (ii)    Canada;    (iii)
   France, Germany, Italy, Spain, and the United Kingdom (each, a “Major
European Market”); and    (iv)    Japan or China (each, a “Major Asian Market”).
“Milestone(s)”:    shall have the meaning ascribed to this term in Section 6.3.
“NDA”:    shall mean a “New Drug Application” (as more fully defined in 21
C.F.R. 314.5 et seq.) filed with the FDA or the equivalent application filed
with any other Regulatory Authority to obtain marketing approval for a Product
in a country or jurisdiction in the Territory. “Net Sales”:    shall mean, with
respect to a Product, the gross amounts billed or invoiced either (a) by
Debiopharm or (b) its Affiliates, in each case, for sales of Products to Third
Parties (excluding sales of Products to Sublicensees for resale), less the
following items, as allocable to such Products (if not previously deducted in
calculating the amount invoiced):    (i)    deductions for returns (including
allowances actually given for spoiled, damaged, out-dated, rejected, returned
Product sold, withdrawals and recalls),    (ii)    rebates (price reductions,
including Medicaid, rebates to social and welfare systems and similar types of
rebates e.g. chargebacks, government mandated rebates) actually allowed or paid,
   (iii)    volume (quantity) discounts or other discounts granted at the time
of invoicing, and    (iv)    value added or sales taxes and other taxes directly
linked to and included in the gross sales amount,    it being specified that
disposal of Product for, or use of Product in, clinical or pre-clinical trials,
or distribution of Product as free samples (such samples to be in quantities
common in the industry for this type of pharmaceutical products) shall not give
rise to any deemed sale under this definition.    No deductions shall be made
for commissions to any person on Debiopharm’s or an Affiliate’s payroll or for
the cost of collection.

 

 

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   For purposes of calculating Net Sales, if a Combination Product is sold by
Debiopharm or its Affiliates, the Net Sales of such Combination Product shall be
determined by multiplying the Net Sales (as defined above in this definition of
“Net Sales”) of the Combination Product by the fraction, A/(A+B) where A is the
weighted (by sales volume) average sale price of the Product when sold
separately in finished form and B is the weighted (by sales volume) average sale
price of the other product(s) sold separately in finished form. In the event
that such weighted average sale price cannot be determined for both the Product
and the other product(s) in combination, Net Sales for purposes of determining
royalty payments shall be agreed in good faith by the Parties based on the
relative value contributed by each component. “Party”:    shall mean either
Debiopharm or Curis, as the context requires, or both Debiopharm and Curis when
used in the plural form “Parties”. “Patent(s)”:    shall mean the Curis Patents,
Debiopharm Patents and/or Joint Patents. “Phase I Study”:    shall mean a
clinical study consistent with U.S. 21 CFR paragraph 312.21 (a) or any foreign
counterpart of it. In oncology development, any possible expansion of a Phase I
Study in specific indications under a phase I protocol, which might follow the
dose escalation phase, is considered as the same Phase I Study. “Phase II
Study”:    shall mean a clinical study consistent with U.S. 21 CFR paragraph
312.21 (b) or any foreign counterpart of it. “Phase III Study”:    shall mean
those tests and studies in humans as described in the U.S. 21 CFR paragraph
312.21 (c) or any foreign counterpart of it. “Product(s)”:    shall mean any
product containing the Compound, whether or not as the sole active ingredient,
in any dosage form and formulation and for all present and future Indications.
“Reasonable Commercial Efforts”:    shall mean the efforts required in order to
carry out a task or objective in a diligent and sustained manner without undue
interruption, pause or delay, which level is at least commensurate with the
level of efforts that a pharmaceutical company would devote to a product of
similar potential and having similar commercial and scientific advantages and
disadvantages as compared to the Product hereunder. Reasonable Commercial
Efforts requires (without limitation) that the Party exerting such efforts (i)
promptly assign responsibility for its obligations to

 

 

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   specific employee(s) or contractor(s) who are held accountable for progress
and monitor such progress, on an ongoing basis, (ii) set and continue to seek to
achieve specific and meaningful objectives for carrying out such obligations,
and (iii) consistently make and implement decisions and allocate resources
designed to advance progress with respect to such objectives, in each case in a
commercially reasonable manner. “Regulatory Authority”:    means the relevant
governmental or other authority responsible in any particular jurisdiction for
regulation, licensing, evaluation and supervision of Products in the Field of
Use, including without limitation the FDA and the EMEA. “Royalties”:    shall
mean the royalties to be paid by Debiopharm to Curis (a) on the basis of Net
Sales or (b) on the basis of Sublicensee Royalties, as applicable. “Royalty
Term”:    shall mean, on a country-by-country basis, the period beginning upon
the First Commercial Sale of a Product in a country of the Territory and ending
upon the later of: (a) expiration of the last-to-expire valid claim of the Curis
Patents and the Joint Patents, which valid claim covers the composition of
matter, or any method of manufacture or use, of the Product (or the Compound
contained therein) in such country; and (b) the tenth (10th) anniversary of the
First Commercial Sale of the Product in such country. “Sublicensee(s)”:    shall
mean any Third Party to whom Debiopharm, or any of its Affiliates, has
sublicensed any of Debiopharm’s rights under the license granted to Debiopharm
pursuant to Section 2.1. “Sublicensee Royalties”:    shall mean all royalties
paid by any Sublicensee to Debiopharm or any of its Affiliates with respect to
sales of Products by such Sublicensee or its further sublicensees. “Sublicensing
Payments”:    shall mean consideration in any form received by Debiopharm or any
of its Affiliates in connection with a grant to any Third Party(ies) of a
sublicense or other right, license, privilege or immunity to develop, have
developed, make, have made, use, sell, have sold, distribute, import or export
Products, but excluding Sublicensee Royalties. Sublicensing Payments shall
include, without limitation:    (i) any upfront or license signing fee;    (ii)
any license maintenance fee;    (iii) any milestone payments (including, without
limitation development, regulatory and sales-based milestone payments);    (iv)
the portion of any minimum royalty payment received by Debiopharm or any of its
Affiliates in excess of Sublicensee Royalties received;

 

 

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   (v) if a Sublicensee issues equity or debt securities to Debiopharm or its
Affiliate in connection with a sublicense grant, the fair market value of such
securities issued to Debiopharm or its Affiliate (such fair market value to be
determined by agreement of Debiopharm and Curis or by an independent appraiser
mutually agreeable to Debiopharm and Curis), net of any cash consideration paid
by Debiopharm or its Affiliate for such securities;    (vi) any distribution or
joint marketing fee;    (vii) research and development funding in excess of
Debiopharm’s or its Affiliates’ actual cost of performing such research and
development (calculated on a fully-burdened basis in accordance with
Debiopharm’s or its Affiliate’s project- or activity-based accounting practices,
as applied consistently throughout its accounting system); and    (viii) if
Debiopharm or its Affiliate sells equity or debt securities to a Sublicensee in
connection with a sublicense grant, any consideration received by Debiopharm or
its Affiliate for such securities to the extent such consideration exceeds the
fair market value of such securities (such fair market value to be determined by
agreement of Debiopharm and Curis or by an independent appraiser mutually
agreeable to Debiopharm and Curis). “Technology Transfer Plan”:    shall have
the meaning ascribed to this term in Section 3.1.1. “Term”:    shall have the
meaning ascribed to this term in Section 11.1. “Territory”:    shall mean the
entire world. “Third Party”:    shall mean any entity other than Debiopharm or
Curis or an Affiliate of Debiopharm or Curis. “Third Party Intellectual Property
Rights”:    shall have the meaning ascribed to this term in Section 7.1.2.
“Third Party Other Patent Licenses”:    shall have the meaning ascribed to this
term in Sections 6.5.2 and 6.5.3. “Third Party Patent Licenses”:    shall have
the meaning ascribed to this term in Sections 6.5.2 and 6.5.3. “Up-front Fee”:
   shall have the meaning ascribed to this term in Section 6.2.

 

 

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2 LICENSE

 

2.1 Subject to the terms and conditions of this Agreement, Curis grants to
Debiopharm a sole and exclusive license (even as to Curis) in and to the
Compound and the Product under the Curis Intellectual Property Rights and Curis’
interest in the Joint Patents, to develop, have developed, use, have used, sell,
have sold, offer for sale, make, have made, manufacture, have manufactured,
register, have registered, commercialize and have commercialized the Compound
and Products, in any Indication in the Field of Use, in the Territory. For
avoidance of doubt, Curis does not grant to Debiopharm any right or license with
respect to any API other than the Compound.

 

2.2 The license granted to Debiopharm by Curis under Section 2.1 includes the
right for Debiopharm to grant sublicenses to its Affiliates and to Third Parties
for the development, manufacture, sale and/or commercialization of the Compound
and the Product. All sublicenses granted by Debiopharm shall be subject to the
terms and conditions of this Agreement, and Debiopharm shall enter into a
written sublicense agreement with each Sublicensee which will contain terms and
conditions fully consistent with the terms and conditions contained in this
Agreement. Debiopharm shall provide to Curis a true and complete copy of each
Commercial Sublicense Agreement entered into by Debiopharm or any of its
Affiliates and any Sublicensee, and of each amendment to any such Commercial
Sublicense Agreement, in each case, within thirty (30) days after execution of
such Commercial Sublicense Agreement or amendment, provided that Debiopharm may
redact from such copy any sensitive or proprietary information that is not
necessary to ascertain Debiopharm’s, its Affiliate’s or a Sublicensee’s
compliance with the terms and conditions of this Agreement (including, without
limitation, Debiopharm’s payment and reporting obligations hereunder). For the
purpose of this Section 2.2, the term “Commercial Sublicense Agreement” shall
mean any agreement executed by Debiopharm or any of its Affiliates under which
any of Debiopharm’s rights under the license granted to Debiopharm pursuant to
Section 2.1 are sublicensed; provided, however, that the term Commercial
Sublicense Agreement shall exclude any agreement between Debiopharm or its
Affiliate and a Third Party service provider under which a sublicense is granted
to such Third Party for the sole purpose of enabling such Third Party to perform
contract services on behalf of Debiopharm or its Affiliate (e.g., contract
research or development organizations, clinical sites performing clinical
trials, universities and scientific institutes, and contract manufacturing
organizations). In addition, Debiopharm shall notify Curis in writing of the
termination of any Commercial Sublicense Agreement within thirty (30) days after
such termination. If Debiopharm determines that there is a reasonable likelihood
of its execution of a Commercial Sublicense Agreement or an amendment to, or
termination of, an existing Commercial Sublicense Agreement, Debiopharm shall
use reasonable efforts to provide notice thereof to Curis, which notice shall be
provided solely for Curis’ information and planning purposes. No sublicense
hereunder shall limit or affect the obligations of Debiopharm under this
Agreement, and Debiopharm shall remain fully responsible for each Affiliate’s or
Sublicensee’s compliance with the applicable terms and conditions of this
Agreement.

 

2.3 Except as expressly provided in this Agreement, no license or other right is
or shall be created or granted hereunder by implication, estoppel or otherwise.

 

 

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3 DEVELOPMENT PLAN

 

3.1. Obligations of Curis

 

3.1.1 As soon as possible after the Effective Date, Curis shall use its
Reasonable Commercial Efforts to transfer, at no costs to Debiopharm, all Curis
Know-How that is necessary for Debiopharm to continue the development of the
Compound and the Products in accordance with the Development Plan. Without
limiting the generality of the foregoing, Curis shall use Reasonable Commercial
Efforts to transfer the information and materials set forth in the technology
transfer plan attached hereto as Exhibit 4 (the “Technology Transfer Plan”) on
the timeline set forth in the Technology Transfer Plan. Curis shall supply
Debiopharm at costs, as indicated in this Section 3.1.1, as soon as possible,
but in any event within thirty (30) days, with the amount of Compound [**] for
use in clinical studies that is requested by Debiopharm. Curis has an available
stock of Compound (GMP quality) of [**]. For the avoidance of doubt, Debiopharm
shall not be under any obligation to purchase any quantity of the available
stock of Compound held by Curis. Curis shall also provide compound stability
data to Debiopharm as such data is received [**]. Stability data developed prior
to the Effective Date shall be communicated to Debiopharm free of charge, and
Curis shall invoice Debiopharm quarterly at cost for stability data developed
during the Term. In addition, Curis shall provide samples of Compound
intermediate and non-GLP Compound to Debiopharm as requested by Debiopharm
during the first six (6) months following the Effective Date, provided such
Compound intermediate or non-GLP Compound are available. Curis will invoice
Debiopharm for such Compound intermediate and/or non-GLP Compound at an amount
equal to its cost. Curis shall have no obligation to procure or supply any
quantities of Compound [**] beyond the quantities specified in the preceding
sentence. Curis will invoice Debiopharm for Compound [**] requested by
Debiopharm and shipped to Debiopharm by Curis. Payment shall be made [**].
Debiopharm shall review such data as is needed [**] thereof. Subject to
Debiopharm’s right to [**] of such Compound [**] as set forth above, Debiopharm
shall make payment on Curis’ invoices under this Section 3.1.1 within forty-five
(45) days of invoice.

 

3.1.2 At no cost to Debiopharm, Curis shall provide a reasonable amount of
technical, scientific and intellectual property support to the Development Plan,
as requested by Debiopharm, during the six- (6-) month period beginning on the
Effective Date.

 

3.1.3 During the period beginning on the Effective Date and ending upon filing
of the first IND or CTA for the Compound or the Product in a Major Market, and
if requested in writing by Debiopharm, Curis shall perform the preclinical
study(ies) as set forth in the Technology Transfer Plan and shall engage
contract service providers and/or outside consultants as reasonably necessary in
connection with such studies. Debiopharm shall reimburse Curis for the cost of
these studies (including fees and costs paid to such service providers and
consultants). Curis shall provide an original invoice for such costs to
Debiopharm, who shall pay within forty-five (45) days of receipt of such
invoice.

 

3.2 Obligations of Debiopharm

 

3.2.1

Debiopharm shall undertake Reasonable Commercial Efforts to develop, register
and commercialize the Product in the Field of Use in the Major Markets and in
such other markets as Debiopharm deems commercially reasonable. From and after
the Effective Date, Debiopharm shall be solely responsible for all the costs
relating to the

 

 

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development, registration and commercialization of the Product in the Field of
Use. Debiopharm shall solely assume the managing and the financing of the
Development Plan, with the objective of verifying the safety, potency and
efficacy of the Product and, if the results of clinical development are
positive, filing applications for NDA approval in an expeditious manner, within
the limits of the demands of the Regulatory Authorities and consistent with
Reasonable Commercial Efforts, as more fully described below in this
Section 3.2. Debiopharm shall retain final decision making authority on all
development, commercialization, marketing, manufacturing and regulatory matters
relating to the Product; provided, however, that Debiopharm shall (i) provide
Curis the opportunity to review and comment on protocols for clinical trials of
which Debiopharm or its Affiliate will be the sponsor and proposed labeling for
the Product in each country of the Territory, in each case, reasonably in
advance of submission by Debiopharm or any of its Affiliates (but, for the
avoidance of doubt, not Sublicensees) to the applicable Regulatory Authority of
any such clinical trial protocol or any regulatory filing regarding Product
labeling, and (ii) consider Curis’s comments with respect to such clinical trial
protocols and Product labeling in good faith.

 

3.2.2 Debiopharm shall conduct the Development Plan in accordance with all
applicable laws, rules and regulations, and current good manufacturing practice
(cGMP), current good laboratory practice (cGLP) and current good clinical
practice (cGCP), where applicable.

 

3.2.3 The Development Plan will be updated from time to time in accordance
herewith and such updates shall be attached hereto as Exhibit 3. The Development
Plan indicates in reasonable details Debiopharm’s plans for the development of
Product in the Field of Use, including regulatory and registration strategy
consistent with Reasonable Commercial Efforts. Without limiting the generality
of any of the foregoing obligations in this Section 3.2.3, Debiopharm shall use
Reasonable Commercial Efforts to implement the Development Plan within the
timelines described therein. Debiopharm may reasonably revise and amend the
Development Plan from time to time upon as much advance notice to Curis as is
practicable under the circumstances, so long as such amended Development Plan
meets the criteria described above but in particular in the event the
assumptions described therein are not met; provided, however, that at Curis’
request, the Parties shall promptly convene a special JSC meeting at which
Debiopharm will present its rationale for such amendment and, if Curis in good
faith believes such amendment is inadvisable for scientific, clinical or
regulatory reasons, Curis may present its position to Debiopharm, which
Debiopharm agrees to consider in good faith. Notwithstanding any of the
foregoing, nothing in this Agreement shall be construed as a representation or
warranty by Debiopharm as to a successful outcome of the development of the
Product and/or issuance of regulatory approvals and/or commercialization in any
country.

 

3.2.4 If at any time Debiopharm definitively and formally suspends its research
or development efforts for the Product, or definitively and formally makes an
internal determination to suspend research and development of the Product, for a
period exceeding sixty (60) days, Debiopharm shall notify Curis giving reasons
and a statement of its intended actions.

 

3.2.5 (a) Subject to [**] (the preceding clauses (i) through (iii),
collectively, the “IND/CTA Filing Conditions”), Debiopharm shall file an IND or
CTA for the Compound or the Product in a Major Market by the date that is [**]
months after delivery by Curis of all of the aforementioned items (the “IND/CTA
Filing Deadline”), unless Debiopharm can demonstrate that extending the date to
[**] months after such delivery is reasonable and appropriate as a result of
circumstances beyond Debiopharm’s reasonable control.

 

 

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(b) If the IND/CTA Filing Conditions are met and Debiopharm fails to file an IND
or CTA in a Major Market on or before the applicable IND/CTA Filing Deadline
(other than for reasons beyond the reasonable control of Debiopharm, such as the
requirements of the applicable Regulatory Authority), Curis may terminate this
Agreement in accordance with Section 12.3.

(c) In any event, Debiopharm shall use Reasonable Commercial Efforts to file an
IND or CTA in a Major Market as promptly as practicable after the Effective
Date. Curis acknowledges that the approval (either written or tacit) of any
Regulatory Authority of any such IND or CTA is not within Debiopharm’s control.

 

3.2.6 In addition to its obligation under Section 3.2.5, Debiopharm shall be
obligated to make Reasonable Commercial Efforts to develop itself or through
Affiliates, subcontractors and/or Sublicensees at least one (1) Compound.
Factors to consider as Reasonable Commercial Efforts shall be as follows: [**].
If Curis considers that Debiopharm has failed to exercise Reasonable Commercial
Efforts, then Curis shall notify Debiopharm in writing within thirty (30) days
of appearance of such potential failure thereof stating in reasonable detail the
particular alleged failure.

(a) If Debiopharm disagrees with Curis’s claim that Debiopharm has failed to
exercise Reasonable Commercial Efforts, Debiopharm shall so notify Curis in
writing within thirty (30) days after receipt of Curis’s notice, in which event
the Parties shall promptly refer the matter to a Third Party expert in drug
development, completely unaffiliated and independent of the Parties and jointly
selected by the Parties, to determine whether a failure by Debiopharm to use
Reasonable Commercial Efforts occurred, or if the related problem was due to
some other cause. Neither Party shall unreasonably withhold or delay its
approval of such expert. The Parties shall initially share equally the fees and
costs of such expert, but promptly after such expert makes a determination
regarding the matter, the non-prevailing Party shall reimburse the prevailing
Party for the share of such fees and costs borne by the prevailing Party. Should
it be determined by the expert that such failure resulted from Debiopharm’s
failure to use Reasonable Commercial Efforts to perform its obligations and
tasks assigned to it under the Development Plan, then the expert shall determine
what corrective action by Debiopharm would best meet the standard of Reasonable
Commercial Efforts and a timeframe for the completion of such corrective action
by Debiopharm. The determination of such expert shall be final and binding on
the Parties.

(b) If Debiopharm does not correct such alleged failure either: (i) within
ninety (90) days after notice of such alleged failure from Curis; or (ii) if
Debiopharm disputes Curis’s allegation of failure to use Reasonable Commercial
Efforts in accordance with the preceding paragraph (a), within the period
specified by the expert; then, in each case, Curis shall have the right to
terminate this Agreement in accordance with Section 12.4.

 

3.2.7 Debiopharm shall maintain complete and accurate records of all work,
including research, development, clinical, manufacturing and commercialization
activities with respect to the Product conducted by Debiopharm under this
Agreement, together with all results, data and developments made or generated in
connection with any of the foregoing. Such records shall fully and properly
reflect all work done and results achieved in the performance of this Agreement
in sufficient detail and in good scientific manner appropriate for patent and
regulatory purposes.

 

 

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3.2.8 During the Term, Debiopharm shall keep Curis regularly informed in
reasonable detail regarding Debiopharm’s worldwide Product development. The
detailed minutes of the JSC shall constitute the written progress report
summarizing the status of the Product development, clinical trial progress,
regulatory approval and commercialization. In addition, throughout the Term,
Debiopharm shall notify Curis promptly of the occurrence of the following by a
Product: (i) initiation of any Phase II Study in a Major Market; (ii) initiation
of any Phase III Study in a Major Market; (iii) NDA filing in any Major Market;
(iv) NDA approval in any Major Market; and (v) First Commercial Sale in any
Major Market. Debiopharm shall also respond to reasonable (i.e., not unduly
frequent or burdensome) informal requests from Curis for additional information
regarding the development of the Product from time to time.

 

3.2.9 Curis agrees that the results of the Development Plan cannot be accurately
predicted, that Debiopharm’s obligation with respect to the Development Plan is
not an obligation to obtain a particular result and that Debiopharm does not
warrant or guarantee that the Development Plan will yield any useful or
anticipated results.

 

4 JOINT STEERING COMMITTEE

 

4.1 The JSC shall be comprised of a minimum of four (4) committee members, which
shall consist of two (2) representatives nominated by each Party.
Representatives will include persons having knowledge in the areas of
responsibility of the JSC. The Parties may mutually agree to change the total
number of representatives on the JSC, provided that the Parties always have an
equal number of representatives. Each Party may replace any of its JSC
representatives at any time upon written notice to the other Party. The JSC may
invite non-members to participate in the discussions and meetings of the JSC,
including experts bound by appropriate confidentiality obligations. The JSC
shall continue to exist and meet during the Term or until the Parties mutually
agree that it should disband. Each Party shall be responsible for all travel and
related costs for such Party’s representatives and guests to attend meetings of,
and otherwise participate on, the JSC.

 

4.2 The JSC shall meet at least [**] during the first year of the Term and [**]
thereafter at times established by the Parties. Each Party shall also have the
right to request additional meetings of the JSC for good reason. Meetings will
be in-person, at either of the Parties’ offices or be held by videoconference or
teleconference. In the event that a JSC member of a Party cannot attend a
meeting, such Party shall have the right to nominate another representative of
that Party to attend the meeting.

 

4.3 Throughout the Term, the JSC shall function to facilitate the collaboration
and relationship of the Parties under this Agreement, and facilitate the
communication and exchange of information related to research and development of
Products. In addition, for so long as the JSC is in existence, Curis shall
provide reasonable technical and scientific support to the Development Plan
through its participation on the JSC.

 

4.4

The JSC does not have any authority beyond the matters set forth above in this
Article 4, and cannot in any way amend or modify the terms or provisions of this
Agreement, either directly or indirectly through changes to the Development
Plan. Debiopharm shall have

 

 

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the sole and final right to take decisions with regard to the development of the
Product, including “Go” and “No Go” decisions, which decisions shall be made in
good faith and consistent with the objectives and intentions of this Agreement.

 

4.5 Debiopharm shall circulate a draft of the minutes of each meeting to all
members of the JSC for comments within fifteen (15) days after such meeting.
Such minutes shall summarize the status of the Product development, clinical
trial progress, regulatory approval and commercialization and shall provide a
description, in reasonable detail, of the discussions at the meeting, a list of
any actions or determinations approved by the JSC at such meeting, and a
description of any issues within the JSC that were not resolved at such meeting.
Curis shall promptly provide to Debiopharm any comments Curis may have regarding
the draft minutes, and the Parties shall discuss the same in good faith and use
all reasonable efforts to finalize the minutes no later than thirty (30) days
after such JSC meeting. All final JSC minutes must be signed by both Parties.

 

5 MANUFACTURE, RELEASE AND SUPPLY OF THE PRODUCT

 

5.1 Debiopharm shall have the exclusive right (even as to Curis) to manufacture,
or have manufactured the Compound and the Product according to the terms and
conditions of this Agreement. Debiopharm will, at its own discretion, execute
manufacturing and supply agreements with contractors and determine the sites for
the manufacture, release and supply of the Compound and the Product.

 

6 CONSIDERATION

 

6.1 As consideration for the exclusive license rights provided in Section 2.1,
Debiopharm shall pay to Curis the amounts set forth in this Article 6.

 

6.2 Up-front Fee

Debiopharm shall pay a non-refundable up-front fee of Two Million United States
Dollars (US$2,000,000) (the “Up-front Fee”). Upon signature of this Agreement,
Curis shall provide an original invoice for the Up-front Fee to Debiopharm, who
shall pay within thirty (30) days of receipt of such invoice, provided that all
documents listed in section (a)(i) of the Technology Transfer Plan have been
delivered to Debiopharm by Curis.

 

6.3 Milestones

Debiopharm shall pay the non-refundable milestones set forth in this Section 6.3
(“Milestone(s)”), for each of the following milestone events, whether such
milestone event is achieved by Debiopharm, its Affiliates, its Sublicensees or
any Third Party acting on behalf of Debiopharm, its Affiliates or its
Sublicensees. Milestones shall be paid only once regardless of how many times a
Product achieves the corresponding milestone event, and no payment shall be due
for any milestone event which is not achieved, except as provided in the last
sentence of this Section 6.3.

 

 

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Payment to Curis

in United States
Dollars

 

Early Milestones

 

    

 

Upon the first approval (either written or tacit) by a Regulatory Authority in a
Major Market for an open IND or CTA application permitting the initiation of
human clinical trials (the “IND/CTA Approval Milestone”):

   US$[**]

 

Upon the administration of the 5th patient in the 1st Phase I Study, anywhere in
the Territory:

   US$[**]

 

Advanced Milestones

 

    

 

Upon the administration of the 5th patient in the 1st Phase II Study in the 1st
Indication, anywhere in the Territory:

   US$[**]

 

Upon the administration of the 5th patient in the 1st Phase II Study in the 2nd
Indication, anywhere in the Territory:

   US$[**]

 

Upon the administration of the 5th patient in the 1st Phase II Study in the 3rd
Indication, anywhere in the Territory:

   US$[**]

 

Upon the administration of the 5th patient in the 1st Phase III Study in the 1st
Indication, anywhere in the Territory:

   US$[**]

 

Upon the administration of the 5th patient in the 1st Phase III Study in the 2nd
Indication, anywhere in the Territory:

   US$[**]

 

Upon the administration of the 5th patient in the 1st Phase III Study in the 3rd
Indication, anywhere in the Territory:

   US$[**]

 

Acceptance of NDA by the FDA:

   US$[**]

 

Acceptance of NDA in the first Major European Market:

   US$[**]

 

Acceptance of NDA in the first Major Asian Market:

   US$[**]

 

First marketing approval in the United States of America:

   US$[**]

 

First marketing approval in the first Major European Market:

   US$[**]

 

First marketing approval in the first Major Asian Market:

 

  

US$[**]

 

Debiopharm shall provide Curis with written notice within ten (10) working days
of the occurrence of any of the foregoing milestone events and the relevant
Milestone is payable by Debiopharm to Curis within thirty (30) days of receipt
of a corresponding invoice issued by Curis. If Debiopharm determines that there
is a reasonable likelihood of a particular Milestone being achieved on or about
a particular date, Debiopharm shall

 

 

Page 16 of 45

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use reasonable efforts to provide advance notice thereof to Curis, which notice
shall be provided solely for Curis’ planning purposes and shall not be construed
as a representation, warranty or covenant by Debiopharm that such Milestone will
occur when anticipated or at all. Furthermore, in the event that a given
milestone event is realized and becomes payable but any milestone event(s) that
constitutes a prior step was never realized and was never paid to Curis, such
prior milestone event(s) shall automatically be deemed to have occurred and
become due and payable together with such occurring milestone event.

 

6.4 Credit Against Sublicensing Payments

The Milestones shall be credited towards the sharing of the Sublicensing
Payments due by Debiopharm to Curis in accordance with Section 6.5.1, but only
if and to the extent that, at the time that such Sublicensing Payment(s) is
(are) received by Debiopharm and such sharing of Sublicensing Payment(s) is
payable to Curis, the aggregate share of Sublicensing Payments actually payable
to Curis exceeds the aggregate of the Milestones actually paid to Curis in
accordance with Section 6.3.

For avoidance of doubt, Milestones received by Curis from Debiopharm are never
creditable against Royalties outlined in Sections 6.5.2 and 6.5.3.

 

6.5 Revenue Sharing

 

6.5.1 Sublicensing Payments

Debiopharm shall pay to Curis [**] percent ([**]%) of all Sublicensing Payments
received by Debiopharm and its Affiliates from Sublicensees subject to the
credits made in accordance with Section 6.4. Such payments shall be made to
Curis within forty-five (45) days as of receipt by Debiopharm of the related
Sublicensing Payments.

 

6.5.2 Royalties on Sublicensee Royalties

Debiopharm shall pay Curis Royalties on the Sublicensee Royalties Debiopharm and
its Affiliates receive from Sublicensees during the applicable Royalty Term for
each country as follows:

 

Annual Net Sales by Sublicensees in the Territory   

Royalties (to be paid

by Debiopharm)

Annual Net Sales by Sublicensees below US$[**]:   

 

[**]% of Sublicensee Royalties received

Annual Net Sales of Sublicensees between US$[**] and US$[**]:   

 

[**]% of Sublicensee Royalties received

Annual Net Sales of Sublicensees above US$[**]:   

 

[**]% of Sublicensee Royalties received

Royalties shall be payable on a country-by-country basis until expiration of the
applicable Royalty Term for each country.

 

 

Page 17 of 45

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  (a) Third Party Patents.

(i) If Debiopharm reasonably determines, upon the advice of outside patent
counsel, that it must obtain one or more licenses under issued patents of Third
Parties that, in the absence of such license(s), would be infringed by the
development, manufacture, use, sale or import of the Compound per se contained
in a Product in a country (“Third Party Patent Licenses”), then the royalties
actually paid by Debiopharm or its Affiliate under such Third Party Patent
Licenses in such country shall be deducted from the Royalties due to Curis with
respect to Sublicensee Royalties in such country; provided that in no event
shall any such Royalties due to Curis with respect to such country be reduced by
more than [**] percent ([**]%) as a result of such deductions; and provided,
further, that no such deduction shall be available to Debiopharm with respect to
royalties paid under such Third Party Patent Licenses to the extent that the
Sublicensee is obligated (A) to reimburse Debiopharm or its Affiliates for such
royalties or (B) to pay such royalties directly to the applicable Third
Party(ies) under such Third Party Patent Licenses – i.e., Debiopharm or its
Affiliate shall not be entitled to deduct such Third Party royalties against
Royalties due Curis to the extent that Debiopharm or its Affiliate is not liable
for, or Debiopharm or its Affiliate recovers, or has the right to recover, such
Third Party royalties from a Sublicensee.

(ii) If Debiopharm reasonably determines to secure a license from a Third Party
other than for the Compound per se (“Third Party Other Patent Licenses”), then
[**] percent ([**]%) of the royalties actually paid by Debiopharm or its
Affiliate under such Third Party Other Patent Licenses in such country shall be
deducted from the Royalties due to Curis with respect to Sublicensee Royalties
in such country; provided that in no event shall any Royalties due to Curis with
respect to such country be reduced by more than [**] percent ([**]%) as a result
of such deductions; and provided, further, that no such deduction shall be
available to Debiopharm with respect to royalties paid under such Third Party
Other Patent Licenses to the extent that the Sublicensee is obligated (A) to
reimburse Debiopharm or its Affiliate for such royalties or (B) to pay such
royalties directly to the applicable Third Party(ies) under such Third Party
Other Patent Licenses – i.e., Debiopharm shall not be entitled to deduct such
Third Party royalties against Royalties due to Curis to the extent that
Debiopharm or its Affiliate is not liable for, or Debiopharm or its Affiliate
recovers, or has the right to recover, such Third Party royalties from a
Sublicensee.

(iii) Notwithstanding the foregoing, in no event shall any and all applicable
royalty reductions pursuant to subparagraphs (i) and (ii) above, in the
aggregate, reduce the payments that would otherwise be due to Curis with respect
to Sublicensee Royalties in any country for any calendar quarter by more than
[**] percent ([**]%).

 

  (b) Generic Competition.

On a country-by-country basis, if at any time with respect to a Product being
sold by a Sublicensee in a given country (i) one or more Third Parties is
selling Generic Products in such country, and (ii) Generic Market Penetration
(defined below) in such country equals or exceeds the applicable percentage set
forth below, then the applicable royalty rate above shall be reduced by the
corresponding percentage set forth below in such country in each subsequent
calendar quarter of the Royalty Term for such Product in such country. For
purposes of this Section 6.5.2(b), the “Generic Market Penetration” in a country
shall be calculated using the formula [**]. For purposes of the foregoing
calculation, the [**] shall be determined by [**] (it being understood that if,
in calculating [**].

 

 

Page 18 of 45

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Generic Market Penetration   

Percentage reduction in

Royalties

 

Greater than [**]% but less than [**]%

  

 

[**]%

 

Equal to or greater than [**]%

  

 

[**]%

 

6.5.3 Royalties on Net Sales

Subject to Section 6.7.1(a), In the event that Debiopharm and/or its Affiliates
make direct sales of the Product, i.e., without involvement of a Sublicensee,
Debiopharm shall pay to Curis Royalties calculated on Net Sales as follows:

 

Annual Net Sales by Debiopharm and its Affiliates in the Territory   

Royalties (to be paid

by Debiopharm)

 

Annual Net Sales by Debiopharm and/or its Affiliates below US$[**]:

  

 

[**]% of Net Sales

 

Annual Net Sales by Debiopharm and/or its Affiliates between US$[**] and
US$[**]:

  

 

[**]% of Net Sales

 

Annual Net Sales by Debiopharm and/or its Affiliates above US$[**]:

  

 

[**]% of Net Sales

 

  (a) Third Party Patents.

(i) If Debiopharm reasonably determines, upon the advice of outside patent
counsel, that it must obtain one or more licenses under issued patents of Third
Parties that, in the absence of such license(s), would be infringed by the
development, manufacture, use, sale or import of the Compound per se contained
in a Product in a country (“Third Party Patent Licenses”), then the royalties
actually paid by Debiopharm or its Affiliate under such Third Party Patent
Licenses in such country shall be deducted from the Royalties due to Curis with
respect to Net Sales of such Product in such country; provided that in no event
shall the Royalties due to Curis with respect to Net Sales of such Product in
such country be reduced by more than [**] percent ([**]%) as a result of such
deductions.

(ii) If Debiopharm reasonably determines to secure a license from a Third Party
other than for the Compound per se (“Third Party Other Patent Licenses”), then
[**] percent ([**]%) of the royalties actually paid by Debiopharm or its
Affiliate under such Third Party Other Patent Licenses in such country shall be
deducted against the Royalties due to Curis with respect to such country;
provided that in no event shall any such Royalties due to Curis with respect to
such country be reduced by more than [**] percent ([**]%) as a result of such
credits.

 

 

Page 19 of 45

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(iii) Notwithstanding the foregoing, in no event shall any and all applicable
royalty reductions pursuant to subparagraphs (i) and (ii) above, in the
aggregate, reduce the Royalties that would otherwise be due to Curis in any
country for any calendar quarter by more than [**] percent ([**]%).

 

  (b) Generic Competition.

On a country-by-country basis, if at any time with respect to a Product being
sold by a Debiopharm or its Affiliate in a given country (i) one or more Third
Parties is selling Generic Products in such country, and (ii) Generic Market
Penetration (defined below) in such country equals or exceeds the applicable
percentage set forth below, then the applicable royalty rate above shall be
reduced by the corresponding percentage set forth below in such country in each
subsequent calendar quarter of the Royalty Term for such Product in such
country. For purposes of this Section 6.5.3(b), the “Generic Market Penetration”
in a country shall be calculated using the formula [**]. For purposes of the
foregoing calculation, [**] shall be determined by [**].

 

Generic Market Penetration   

Percentage reduction in

Royalties

 

Greater than [**]% but less than [**]%

  

 

[**]%

 

Equal to or greater than [**]%

  

 

[**]%

 

  (c) No Payment Reduction Below Zero.

Notwithstanding any other provision of this Agreement to the contrary, under no
circumstances shall any and all deductions and reductions available to
Debiopharm under this Section 6.5.3, in the aggregate, result in any payment
being due by Curis to Debiopharm.

 

6.5.4 Substantial Change in Pricing Profile

The Parties recognize the high importance of competitive cost of finished
products to determine the marketability and profitability of the Product in the
environment of increasing pressure on price for future medication. If during the
development of the Product, but not prior to the initiation of the first Phase
III clinical trial anywhere in the Territory, Debiopharm believes in good faith
that the cost of goods sold of the Product will be non-competitive compared to
then-marketed small molecule cancer products, the parties agree to [**]

[**] will have the right to refer this issue to the JSC for further discussion.
The JSC will discuss in good faith Debiopharm’s [**] in both cases exploring in
detail the rationale for [**]. If the JSC determines that [**], the JSC will
discuss in good faith and, if the Parties’ respective JSC representatives
mutually agree that it is appropriate, will submit to the Parties a proposal to
[**]. Provided that Debiopharm has provided [**], the JSC shall submit such
proposal within [**] after the date Debiopharm refers the matter to the JSC. In
no event shall any such [**]. For clarity, this Section 6.5.4 will in no way
impact the [**].

 

 

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The Parties will examine the JSC’s proposal in good faith and either accept it
and agree to the JSC’s recommended [**], or, if one Party does not agree with
the proposal, will enter into further discussions. If one or both of the Parties
do not agree with the proposal, then the Parties agree to negotiate in good
faith for [**] days from the date that either Curis or Debiopharm notified the
other Party that it did not accept the JSC proposal. Should the Parties not find
an agreement within the aforementioned period of [**] days, this issue will be
referred to the chief executive officer of each Party, who will discuss in good
faith and endeavor to find an agreement. Should the chief executive officers of
the Parties fail to reach an agreement within [**] days as of the date this
matter has been referred to them, the Parties will appoint at Debiopharm’s
expense three independent and neutral arbitrators, whose decision on the [**]
will be binding on the Parties. The arbitrators will review and consider the
data provided by Debiopharm to Curis pursuant to this Section 6.5.4 regarding
[**] and determine if such amounts are reasonable, taking into account whether
and to what extent the difference between the [**]. If the arbitrators determine
that [**] are not reasonable, the Parties will ask the arbitrators to determine
[**]. If such recalculation results in [**], then no reduction will be made to
any of the [**]. For the avoidance of doubt, in no event will there be [**].

 

6.6 Copies of Third Party License Agreements

Debiopharm shall provide to Curis a true and complete copy of each Third Party
Patent License and Third Party Other Patent License, and of each amendment to
any such agreement, in each case, within thirty (30) days after execution of
such agreement or amendment, provided that Debiopharm may redact from such copy
any sensitive or proprietary information that is not necessary to ascertain
Debiopharm’s, its Affiliate’s or the applicable Sublicensee’s compliance with
the terms and conditions of this Agreement (including, without limitation,
Debiopharm’s payment and reporting obligations hereunder).

 

6.7 Payments

 

6.7.1 Timing of Royalty Payments and Sharing of Sublicensing Payments.

(a) Royalties on Net Sales shall be paid by Debiopharm to Curis quarterly within
forty-five (45) days after the end of calendar quarter in which such Net Sales
are made (as determined by the date of invoice or billing).

(b) Royalties on Sublicensee Royalties shall be paid by Debiopharm to Curis
quarterly within forty-five (45) days after such Sublicensee Royalties are
received by Debiopharm or its Affiliate. If such Sublicensee Royalties are
significantly overdue, then upon Curis’ request, the Parties agree to discuss
the matter in good faith.

(c) Curis’s share of Sublicensing Payments shall be paid by Debiopharm to Curis
within forty-five (45) days after such Sublicensing Payments are received by
Debiopharm or its Affiliate.

 

6.7.2

All payments to Curis hereunder shall be made using the bank details provided by
Curis. The payments of Royalties and sharing of Sublicensing Payments shall be
made in United States Dollars. If payments of Sublicensee Royalties, Net Sales,
or Sublicensing Payments are made in another currency than the United States
Dollar, Debiopharm shall convert them into United Sates Dollars for the purpose
of the calculation of Royalties

 

 

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and sharing of Sublicensing Payments by applying the average interbank exchange
rate as published on www.oanda.com for the last day of each month within the
calendar quarter for which payment to Curis is due. All costs associated with
making payments to Curis, including the cost of wire transfers, shall be paid by
Debiopharm and shall not be deducted from the payments to Curis.

 

6.7.3 Debiopharm shall (and shall require its Affiliates to) prepare and
maintain complete and accurate books and records regarding Net Sales (including
gross sales and applicable deductions from gross sales), Sublicensee Royalties,
royalties paid to Third Parties under Third Party Patent Licenses and Third
Party Other Patent Licenses, Sublicensing Payments and Royalties due hereunder
for a period of at least two (2) calendar years after the end of the calendar
year in which such activities occurred. Curis shall have the right to have such
books and records inspected by an independent certified auditor selected by
Curis and accepted by Debiopharm, whose acceptance shall not be unreasonably
withheld, to confirm Net Sales (including gross sales and applicable deductions
from gross sales), Sublicensee Royalties, royalties paid to Third Parties under
Third Party Patent Licenses and Third Party Other Patent Licenses, Sublicensing
Payments and Royalties due hereunder, for a period covering not more than the
preceding two (2) calendar years. Such auditor will execute a reasonable written
confidentiality agreement with Debiopharm and will disclose to Curis only such
information as is reasonably necessary to provide Curis with information
regarding any actual discrepancies between the amounts reported or paid and the
amounts payable under this Agreement. Such auditor will send a copy of its
report to Debiopharm within fifteen (15) days of delivery of such report to
Curis. Such report will include the methodology and calculations used to
determine the results. Prompt adjustments shall be made by the Parties to
reflect the results of such audit. Records to be available under an inspection
shall include all relevant documents pertaining to payments specified above,
including all relevant documents received by Debiopharm from Sublicensees. The
appointed auditor shall have the right to interview selected staff and copy
relevant documents. Such right may be exercised by Curis only once per calendar
year. Curis shall bear the fees and expenses of such inspection, provided that,
if an underpayment of more than five percent (5%) of the payments due for any
calendar year is discovered in any inspection, then Debiopharm shall bear all
fees and expenses of that inspection within forty-five (45) days after receipt
of invoice from Curis, and shall pay to Curis within forty-five (45) days after
receipt of the auditor’s report the deficiency not previously paid, plus accrued
interest on the underpayment at the floating rate of LIBOR [**] (as quoted in
The Wall Street Journal or its successor on the day after the payment is due)
calculated from the due date to the date paid in full.

 

6.7.4 Without limiting any other rights or remedies available to Curis,
Debiopharm shall pay Curis interest on any payments that are not paid on or
before [**] days from the due date at the floating rate of LIBOR [**] (as quoted
in The Wall Street Journal or its successor on the day after the payment is due)
calculated from the due date to the date paid in full.

 

6.7.5 In the event Debiopharm fails to pay overdue amounts to Curis within the
due date under this Section 6.7, Curis shall have the right to terminate this
Agreement upon forty-five (45) days’ prior written notice to Debiopharm pursuant
to Section 12.5, unless Debiopharm has cured such failure to pay by the end of
such forty-five (45-) day period.

 

6.7.6

Debiopharm shall make payments to Curis under this Agreement withholding any
taxes that may be due with respect to such payments to the extent that such
withholding is

 

 

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required by applicable law. If any taxes are required to be withheld by
Debiopharm, then Debiopharm shall (a) deduct such taxes from the payment made to
Curis, (b) timely pay the taxes to the proper taxing authority, and (c) send
proof of payment to Curis and certify receipt of such payment by the applicable
tax authority within sixty (60) days following such payment.

 

7 INTELLECTUAL PROPERTY

 

7.1 Ownership of Intellectual Property Rights and Inventions

 

7.1.1 The Debiopharm Intellectual Property Rights shall at all times be and
remain the sole property of Debiopharm. The Curis Intellectual Property Rights
shall at all times be and remain the sole property of Curis.

 

7.1.2 Inventorship of inventions conceived of and reduced to practice pursuant
to this Agreement (“Inventions”) shall be determined in accordance with the
rules of inventorship under United States patent laws. Debiopharm shall solely
own all Inventions made solely by one or more Debiopharm employees, and Curis
shall solely own all Inventions made solely by one or more Curis employees. All
Inventions made jointly by one or more Debiopharm employees and one or more
Curis employees (“Joint Inventions”) shall be owned jointly by Debiopharm and
Curis.

 

7.1.3 In the event that it is legally necessary to obtain a license under one or
more Third Party Patents in order for Debiopharm to be able to develop,
manufacture, and/or commercialize the Product in one or more countries of the
Territory, and Debiopharm is unable to obtain such a license, Debiopharm may, at
its election and upon thirty (30) days’ written notice to Curis, either
terminate this Agreement in its entirety or terminate this Agreement for the
relevant country(ies) of the Territory. If Debiopharm terminates this Agreement
in its entirety pursuant to this Section 7.1.3, the consequences of such
termination shall be as set forth in Section 13.4. If Debiopharm terminates its
license in specified country(ies) of the Territory, the consequences of such
termination shall be as set forth in Section 13.2.

 

7.2 Patent Prosecution and Maintenance

 

7.2.1

As from the Effective Date, Debiopharm shall have the first right to prepare,
file, prosecute and maintain the Patents using independent counsel selected by
Debiopharm and agreed to by Curis, at Debiopharm’s sole expense. With respect to
any Patents, Debiopharm shall (a) consult with Curis and keep Curis fully
informed of the progress of all patent applications and patents, including all
issues relating to the preparation, filing, prosecution and maintenance of such
Patents, (b) consult with Curis and keep Curis fully informed about Debiopharm’s
patent strategy with respect to such Patents, (c) provide to Curis advance
copies of documents relevant to preparation, filing, prosecution and maintenance
of such Patents sufficiently in advance of filing to allow Curis a reasonable
opportunity to review and comment on such documents, (d) reasonably consider
Curis’ comments on such patent filings, and (e) provide Curis with final copies
of such documents. Debiopharm agrees to use Reasonable Commercial Efforts to
obtain commercially reasonable patent protection in the best interest of Curis
and Debiopharm. Debiopharm shall control and shall bear any and all costs
regarding the filing, prosecution and maintenance of the Patents in the
Territory, including but not limited to filing applications for, and obtaining,
patent term extensions, supplemental protection

 

 

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certificates (SPC) and the like relating to the Product and in each country of
the Territory where Debiopharm reasonably considers that it is appropriate to do
so. If Debiopharm decides to abandon or not maintain any Patent in the
Territory, then Debiopharm shall provide Curis with sixty (60) days’ prior
written notice of such decision (or such other longer period of time reasonably
necessary to allow Curis to assume such responsibilities, at the sole discretion
of Debiopharm). In such event, Curis shall have the right, at its option, to
control the filing, prosecution and/or maintenance of any such Patent, at its
own expense. Curis shall inform Debiopharm of its decision to file, prosecute or
maintain a Patent in any country. Should Debiopharm exploit, use or benefit from
such a Patent in a country where Curis has filed, prosecuted and/or maintained
such Patent at its own expense, Debiopharm shall reimburse Curis for all
reasonable costs pertaining to the filing, prosecution and/or maintenance of
such Patent in that country upon Debiopharm’s use, exploitation or benefit of
such Patent in such country.

 

7.2.2 Each Party agrees to cooperate fully in the preparation, filing,
prosecution and maintenance of Patents under this Agreement and in the obtaining
and maintenance of any patent extensions, supplementary protection certificates
and the like with respect to any Patents. Such cooperation includes, but is not
limited to, promptly informing the other Party of any matters coming to such
Party’s attention that may affect the preparation, filing, prosecution or
maintenance of any Patents.

 

7.3 Patent Infringement

 

7.3.1 Each Party shall promptly notify the other Party in writing of any alleged
or threatened infringement of any Patent in any country of the Territory of
which it becomes aware. The notifying Party will supply documentation of the
infringing activities that are in its possession to the other Party.

 

7.3.2 Debiopharm shall have the first right but not the obligation to bring and
control any action or proceeding with respect to infringement of any Patent, at
its own expense and by counsel of its own choice, and Curis shall have the
right, at its own expense, to be represented in any such action by counsel of
its own choice. If Debiopharm fails to bring any such action or proceeding
within (a) one hundred twenty (120) days following the notice of alleged
infringement or (b) fifteen (15) days before the time limit, if any, set forth
in the appropriate laws and regulations for the filing of such actions,
whichever comes first, then Curis shall have the right to bring and control any
such action at its own expense and by counsel of its own choice, and Debiopharm
shall have the right, at its own expense, to be represented in any such action
by counsel of its own choice. In the event a Party brings an infringement action
in accordance with this Section 7.3.2, the other Party shall cooperate fully,
including, if required to bring such action, the furnishing of a power of
attorney or being named as a party, in each case, at the expense of the Party
bringing such action. Neither Party shall have the right to settle any patent
infringement litigation under this Section 7.3.2 without the prior written
consent of such other Party, which shall not be unreasonably withheld.

 

7.3.3

Except as otherwise agreed by the Parties in connection with a cost-sharing
arrangement, any recovery realized as a result of any action or proceeding
described in Section 7.3.2 (whether by way of settlement or otherwise) will be
allocated as follows: (a) first, to reimbursement of unreimbursed legal fees and
expenses incurred by the Party that brought and controlled such action or
proceeding; (b) then, to reimbursement

 

 

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of unreimbursed legal fees and expenses of the other Party in connection with
such action or proceeding; and (c) after such reimbursement, any remainder of
such recovery will be allocated [**] percent ([**]%) to the Party that brought
and controlled such action or proceeding and [**] percent ([**]%) to the other
Party.

 

7.4 Infringement of Third Party Patents: Each Party shall promptly notify the
other in writing of any allegation by a Third Party that the development,
manufacture, use, sale, offer for sale or import of the Compound or any Product
pursuant to this Agreement infringes or may infringe such Third Party’s patents.
Debiopharm shall have the first right to undertake and control any defense or
settlement of any such claim at its own expense (subject to Section 6.5) and by
counsel of its own choice, and Curis shall have the right, at its own expense,
to be represented in any such defense by counsel of its own choice. If
Debiopharm fails to undertake the defense or settlement of any such claim by the
earlier of (a) thirty (30) days after receipt of such Third Party’s notice, and
(b) twenty (20) days before the deadline, if any, set by such Third Party or by
applicable laws, rules and regulations for responding to such claim, Curis shall
have the right to undertake and control any defense or settlement of such claim,
at its own expense and by counsel of its own choice, and Debiopharm shall have
the right, at its own expense, to be represented in any such action by counsel
of its own choice. Neither Party shall have the right to settle any Third Party
claim under this Section 7.4 in a manner that diminishes the rights or interests
of the other Party without the written consent of such other Party (which shall
not be unreasonably withheld).

Notwithstanding the foregoing provisions of this Section 7.4, in the event of
[**], Curis shall [**] at its own expense [**] and Debiopharm shall have the
right, at its own expense, [**]. Curis shall [**] under this Section 7.4 [**]
(which shall not be unreasonably withheld). For clarity, this paragraph does not
extend or apply to any such [**] with respect to [**] any Sublicensee.

 

7.5 Patent Marking: Debiopharm shall apply, and shall require Sublicensees to
apply, the patent marking notices required by the law of the countries where
Products are made, sold, used or shipped.

 

7.6 Product Trademarks: Debiopharm shall freely choose, register, use and
license any trademark for the Product (excluding any corporate trademark or
trade name of Curis) in the Field of Use in the Territory. All associated costs
shall be borne by Debiopharm. Such trademarks shall be filed in the name of
Debiopharm (or any Third Party, Affiliates or Sublicensees) and shall remain
Debiopharm’s property after expiration or termination of this Agreement.

 

8 REPRESENTATIONS, WARRANTIES AND CERTAIN COVENANTS

 

8.1 Each Party represents, warrants and covenants to the other that:

 

  (i) It is duly organized and validly existing under the laws of its state or
country of incorporation, and has full corporate power and authority to enter
into this Agreement and to carry out the provisions hereof;

 

  (ii) The execution, delivery and performance of this Agreement by it does not
conflict with any agreement or instrument, oral or written, to which it is a
party or by which it may be bound; and

 

 

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  (iii) It has not granted, and shall not grant, any right to any Third Party
which would conflict with the rights granted to the other Party hereunder.

 

8.2 Curis represents and warrants that as of the Effective Date:

 

  (i) All rights pertaining to the Curis Patents are owned by Curis;

 

  (ii) It has not received any written notice from any Third Party claiming that
the manufacture, use, sale, or importation of the Compound or Product by Curis
prior to the Effective Date infringed any patent owned or controlled by any
Third Party; and

 

  (iii) Curis is not a party to any legal action, suit or proceeding relating to
the Curis Intellectual Property Rights, and Curis has not received any written
communication from any Third Party threatening such action, suit or proceeding;
and

 

  (iv) Curis has the right to grant the license to the Compound under the Curis
Patents and Curis Know-How provided to Debiopharm in Section 2.1; and

 

  (v) To the best of Curis’s knowledge, the use of the Compound in the Field of
Use [**];

 

  (vi) Curis has not granted any license or other right to any Third Party
regarding the Compound and/or the Curis Intellectual Property Rights; and

 

  (vii) Curis has not received any grant from or entered into any agreement with
the United States government and/or any of its subdivisions or federal
governmental bodies, or any governmental bodies outside the United States of
America, regarding the Compound and/or the Curis Intellectual Property Rights.

 

8.3 Debiopharm agrees that all of its activities, and the activities of its
Affiliates and Sublicensees related to its use of the Curis Patents and Curis
Know-How and all development and commercialization of the Product pursuant to
this Agreement shall comply with all applicable legal and regulatory
requirements. Debiopharm, its Affiliates, and Sublicensees shall not knowingly
engage in any activities that use the Curis Patents and/or Curis Know-How in a
manner that is outside the scope of the license rights granted to Debiopharm
hereunder.

 

8.4 Except as expressly set forth in this Agreement, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.

 

9 INDEMNIFICATION AND INSURANCE

 

9.1

Debiopharm shall indemnify, defend, and hold harmless Curis and its Affiliates
and their respective directors, officers, employees and agents (each, a “Curis
Indemnitee”) from and against any and all claims, suits, actions, demands,
liabilities, expenses and/or loss, including reasonable legal expense and
attorneys’ fees (collectively, “Losses”), to which any Curis Indemnitee may
become subject as a result of any claim, demand,

 

 

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action or other proceeding (each, a “Claim”) by any Third Party to the extent
such Losses arise out of or result from (a) any breach by Debiopharm of its
representations, warranties, covenants or obligations in this Agreement or
(b) the development, importation, exportation, storage, handling,
transportation, distribution, marketing, promotion, manufacture, use, sale or
any other disposition of the Compound or any Product by or for Debiopharm, its
Affiliates or Sublicensees hereunder, or (c) the death, personal injury, or
illness of any person or out of damage to any property related in any way to the
rights granted under this Agreement; except, in each case, to the extent such
claim is caused by the gross negligence or willful misconduct of Curis.

 

9.2 Curis shall indemnify, defend, and hold harmless Debiopharm and its
Affiliates and their respective directors, officers, employees and agents (each,
a “Debiopharm Indemnitee”) from and against any and all Losses to which any
Debiopharm Indemnitee may become subject as a result of any Claim by a Third
Party to the extent such Losses arise out of or result from (a) any breach by
Curis of its representations, warranties, covenants or obligations in this
Agreement or (b) the development, importation, exportation, storage, handling,
transportation, manufacture, use or other disposition of the Compound or any
Product by or for Curis or its Affiliates prior to the Effective Date; except,
in each case, to the extent such claim is caused by the gross negligence or
willful misconduct of Debiopharm. In addition, Curis shall indemnify, defend and
hold harmless Sublicensees from and against any and all Losses to which any
Sublicensee may become subject as a result of any claim by a Third Party (other
than another Sublicensee) solely to the extent such Losses arise out of or
result from Curis’ breach of any representation or warranty set forth in
Section 8.2 or breach of the non-competition provisions of Section 14.1.
Notwithstanding the foregoing provisions of this Section 9.2 to the contrary,
Curis’ obligation to indemnify Debiopharm Indemnitees under this Section 9.2
with respect to Curis’ representation and warranty under Section 8.2(v) is
contingent upon Debiopharm’s compliance with its obligations regarding clinical
trial protocols and Product labeling under Section 3.2.1; and Curis’ obligation
to indemnify Sublicensees with respect to Curis’ representation and warranty
under Section 8.2(v) is contingent upon such Sublicensees’ clinical trial
protocols and Product labeling complying with restrictions consistent with the
Parties’ objectives under Section 3.2.1, which restrictions shall be mutually
agreed upon by the Parties in writing prior to Debiopharm’s grant of the first
sublicense. For the avoidance of doubt: (i) except as expressly set forth in
Section 8.2, Curis makes no representation, and extends no warranty, of any kind
with respect to non-infringement of any Third Party patent rights; and
(ii) Curis has no obligation to indemnify, defend or hold harmless
(A) Debiopharm or any of its Affiliates against any allegation that the
development, manufacture, use, sale, offer for sale or import of the Compound or
any Product infringes Third Party patent rights, except in the case of Curis’
breach of the representations and warranties expressly set forth in Section 8.2;
or (B) any Sublicensee with respect to any matter whatsoever, except in the case
of Curis’ breach of the representations and warranties expressly set forth in
Section 8.2 or breach of the non-competition provisions of Section 14.1.

 

9.3

For purposes of Sections 9.1 and 9.2, the Curis Indemnitee or Debiopharm
Indemnitee (the “Indemnified Party”) shall give prompt written notice to the
other Party (the “Indemnifying Party”) of any claims, suits or proceedings by
Third Parties which may give rise to any claim for which indemnification may be
required under Section 9.1 or 9.2; provided, however, that failure to give such
notice shall not relieve the Indemnifying Party of its obligation to provide
indemnification hereunder except, if and to the extent

 

 

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that such failure materially and adversely affects the ability of the
Indemnifying Party to defend the applicable claim, suit or proceeding. The
Indemnifying Party shall be entitled to assume the defense and control of any
such claim at its own cost and expense; provided, however, that the Indemnified
Party shall have the right to be represented by its own counsel at its own cost
in such matters. Neither the Indemnifying Party nor the Indemnified Party shall
settle or dispose of any such matter in any manner which would adversely affect
the rights or interests of the other Party (including the obligation to
indemnify hereunder) without the prior written consent of the other Party, which
shall not be unreasonably withheld or delayed. Each Party shall reasonably
cooperate with the other Party and its counsel in the course of the defense of
any such suit, claim or demand, such cooperation to include without limitation
using reasonable efforts to provide or make available documents, information and
witnesses.

 

9.4 At and during such time as Debiopharm, its Affiliates, or its Sublicensees,
begins clinical testing, sale or distribution of Products, Debiopharm shall (and
shall require its Affiliates and Sublicensees to) at its sole expense, procure
and maintain commercially reasonable insurance policies as would be maintained
by similarly situated pharmaceutical companies consistent with the current
industry standards for similar products, and compliant with any applicable law
or regulation. Such insurance shall (a) provide that the policy is primary and
not excess or contributory with regard to other insurance Curis may have,
(b) include product liability coverage in amounts no less than [**] United
States Dollars (US$[**]) per incident and [**] United States Dollars (US$[**])
annual aggregate, (c) be endorsed to include contractual liability coverage for
Debiopharm’s indemnification under Section 9.1, and (d) by virtue of the minimum
amount of insurance coverage required under Section 9.4(b), not be construed to
create a limit of Debiopharm’s liability with respect to its indemnification
under Section 9.1. Upon request, a copy of such insurance policy shall be sent
to Curis.

 

9.5 IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL,
INDIRECT, PUNITIVE OR SPECIAL DAMAGES OF THE OTHER PARTY ARISING OUT OF OR
RELATED TO THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY EVEN IF
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; provided, however, that this
Section 9.5 shall not be construed to limit either Party’s indemnification
obligations with respect to Third Party claims under Sections 9.1 and 9.2.

 

10 CONFIDENTIALITY

 

10.1 Except to the extent expressly authorized by this Agreement or otherwise
agreed in writing by the Parties, the Receiving Party shall keep confidential
and not publish or otherwise disclose, and shall not use for any purpose other
than as expressly provided in this Agreement, any Confidential Information of
the Disclosing Party. The Receiving Party shall take the same degree of care
that it uses to protect the security and confidentiality of its own confidential
and proprietary information of a similar nature and importance (but in any event
no less than reasonable care) to ensure that its employees, agents, consultants
and other representatives do not make any unauthorized use or disclosure of the
Confidential Information. The Receiving Party shall promptly notify the other
Party upon discovery of any unauthorized use or disclosure of the Confidential
Information.

 

 

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10.2 Subject to Section 10.9, the Receiving Party may disclose Confidential
Information as expressly permitted by this Agreement or if and to the extent
such disclosure is reasonably necessary in the following instances:

(a) filing or prosecuting Patents as permitted by this Agreement;

(b) obtaining and maintaining regulatory filings for Products such Party has a
license or right to develop or commercialize hereunder;

(c) prosecuting or defending litigation;

(d) complying with applicable court orders or governmental regulations;

(e) disclosure to Affiliates, licensees and sublicensees, potential licensees
and sublicensees, employees, consultants or agents of the Receiving Party who
have a need to know such information in order for the Receiving Party to
exercise its rights or fulfill its obligations under this Agreement, provided,
in each case, that any such Affiliate, licensee, sublicensee, potential
licensee, potential sublicensee, employee, consultant or agent agrees to be
bound by terms of confidentiality and non-use no less restrictive than those set
forth in this Article 10; and

(f) disclosure to Third Party investors and potential investors on a
confidential basis in connection with due diligence or similar investigations by
such Third Parties and/or in confidential financing documents, in each case, to
the extent reasonably necessary for such Third Party(ies) to make an investment
decision with respect to the Receiving Party’s securities, provided, in each
case, that any such Third Party agrees to be bound by reasonable obligations of
confidentiality and non-use, and that the Receiving Party shall allow the
Disclosing Party a reasonable opportunity to review the Confidential Information
proposed for disclosure prior to such disclosure.

Notwithstanding the foregoing, in the event the Receiving Party is required to
make a disclosure of Confidential Information pursuant to Section 10.2(c) or
10.2(d), the Receiving Party shall, except where impracticable, give reasonable
advance notice to the Disclosing Party of such required disclosure and, at the
Disclosing Party’s request and expense, cooperate fully with the Disclosing
Party’s lawful efforts to contest such required disclosure, to minimize the
scope of such required disclosure, and/or to obtain a protective order or other
confidential treatment of the Confidential Information required to be disclosed.
In any event, the Receiving Party agrees to take all reasonable action to avoid
disclosure of Confidential Information hereunder.

 

10.3 The Parties agree that the terms of this Agreement shall be treated as
Confidential Information by both Parties.

 

10.4

Debiopharm agrees that Curis may issue a press release upon execution of this
Agreement, subject to Debiopharm’s prior review and approval, such approval not
to be unreasonably withheld or delayed. The Parties further acknowledge that
each Party may desire or be required to issue subsequent press releases or to
make other public disclosures relating to this Agreement or its terms. The
Parties agree to consult with each other reasonably and in good faith with
respect to the text and timing of such press releases or other public
disclosures prior to the issuance thereof, provided that a Party may not
unreasonably withhold consent to such releases, and that either Party may

 

 

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issue such press releases as it determines, based on advice of counsel, are
reasonably necessary to comply with laws or regulations. In addition, following
the initial press release announcing this Agreement, each Party shall be free to
disclose, without the other Party’s prior written consent, the existence of this
Agreement, the identity of the other Party and those terms of this Agreement
which have already been publicly disclosed in accordance herewith.

 

10.5 Subject to Section 10.4, Debiopharm shall not use the name “Curis” nor any
variation or adaptation thereof, nor any trademark, tradename or other
designation owned by Curis or its Affiliates, nor the names of any of its
officers, employees or agents, for any purpose without the prior written consent
of the other Party in each instance, except that Debiopharm may state that it
has licensed from Curis one or more of the patents and/or applications within
the Curis Patents, and Debiopharm may use Curis’s logo on Debiopharm’s corporate
website and corporate presentation materials for such purpose, subject to
Curis’s prior review and approval (not to be unreasonably withheld) of
Debiopharm’s proposed use thereof.

 

10.6 Subject to Section 10.4, Curis shall not use the name of “Debiopharm” or
its Affiliates nor any variation or adaptation thereof, nor any trademark,
tradename or other designation owned by Debiopharm or its Affiliates, nor the
names of any of its officers, employees or agents, for any purpose without the
prior written consent of the other Party in each instance, except that Curis may
state that it has licensed to Debiopharm one or more of the patents and/or
applications within the Curis Patents, and Curis may use Debiopharm’s logo on
Curis’s corporate website and corporate presentation materials for such purpose,
subject to Debiopharm’s prior review and approval (not to be unreasonably
withheld) of Curis’s proposed use thereof.

 

10.7 Each Party recognizes that the publication by Debiopharm of Data and other
information regarding Compounds and Products, such as by public oral
presentation, manuscript or abstract, may be beneficial to both Parties provided
such publications are subject to reasonable controls to protect Confidential
Information. Accordingly, Curis shall have the right to review and comment on
any material proposed for public oral presentation or publication by Debiopharm
that includes Data or other results of preclinical or clinical development of
the Compound or any Product and/or includes Confidential Information of Curis.
Before any such material is submitted for publication, Debiopharm shall deliver
a complete copy to Curis at least forty-five (45) days prior to submitting the
material to a publisher or initiating any other disclosure. Curis shall review
any such material and give its comments to Debiopharm within thirty (30) days of
the delivery of such material to Curis. With respect to public oral presentation
materials and abstracts, Curis shall make reasonable efforts to expedite review
of such materials and abstracts, and shall return such items as soon as
practicable to Debiopharm with appropriate comments, if any, but in no event
later than thirty (30) days from the date of delivery to Curis. Debiopharm shall
comply with Curis’ request to delete references to Curis’s Confidential
Information in any such material. In addition, if any such publication contains
patentable subject matter, then at Curis’ request, Debiopharm shall either
delete the patentable subject matter from such publication or delay any
submission for publication or other public disclosure for a period of up to an
additional sixty (60) days so that appropriate patent applications may be
prepared and filed.

 

10.8

Subject to Section 10.7, Debiopharm and its contractors, including without
limitation clinical research organizations, shall have the right to publish
results of all clinical trials

 

 

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of the Compound or any Product on Debiopharm’s clinical trial register, and such
publication will not be a breach of the confidentiality obligations provided in
this Article 10.

 

10.9 The Parties have determined that [**], including, without limitation, [**]
as evidenced by this Agreement, and have concluded [**]. Accordingly, the
Parties agree as follows:

 

  (a) For purposes of this Section 10.9, [**] shall mean [**].

 

  (b) Debiopharm shall [**].

For clarity, nothing contained in this Section 10.9 is intended to limit, modify
or otherwise affect in any way Curis’ obligations or Debiopharm’s rights [**].

 

10.10 All obligations of confidentiality and non-use imposed under this Article
10 shall expire ten (10) years after the effective date of termination or
expiration of this Agreement, except that Section 10.9 shall survive termination
or expiration of this Agreement indefinitely.

 

11 EXPIRY OF THE AGREEMENT; CONSEQUENCES OF EXPIRY

 

11.1 Unless terminated earlier pursuant to Article 12 or other mutual written
agreement, this Agreement shall commence upon the Effective Date and shall
expire, on a country-by-country basis on the expiration of the Royalty Term.

 

11.2 Upon expiration of the Royalty Term for a given country, Debiopharm’s
license under Section 2.1 with respect to such country shall become fully
paid-up, royalty-free, non-exclusive and transferable.

 

12 TERMINATION

 

12.1 Debiopharm Termination Without Cause: Debiopharm may terminate this
Agreement at any time for any scientific, technical, administrative or
commercial reasons upon ninety (90) days’ prior written notice to Curis.

 

12.2 Debiopharm Termination for Permanent Injunction: In the event Debiopharm is
permanently enjoined from exercising its license under this Agreement pursuant
to a patent infringement action brought by a Third Party, or if neither
Debiopharm nor Curis undertakes the defense or settlement of a Third Party suit
alleging infringement for a within the six- (6-) month period after notice of
such suit, then Debiopharm may terminate this Agreement in the country where
such suit was filed upon thirty (30) days’ prior written notice to Curis.
Debiopharm’s termination right under this Section 12.2 shall be exercisable on a
country-by-country basis. For the avoidance of doubt, any termination by
Debiopharm in accordance with Section 7.1.3 does not fall within the scope of
this Section 12.2.

 

12.3

Curis Termination for Debiopharm Failure to File IND/CTA: If the IND/CTA Filing
Conditions are met and Debiopharm fails to file an IND or CTA in a Major Market
on or before the applicable IND/CTA Filing Deadline under Section 3.2.5 (other
than for reasons beyond the reasonable control of Debiopharm, such as the
requirements of the applicable Regulatory Authority), Curis may terminate this
Agreement on thirty (30) days’

 

 

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written notice to Debiopharm unless Debiopharm makes such filing before the end
of such thirty (30) day period. In the event of such termination, Curis shall
have no claim against Debiopharm with respect to such failure to file.

 

12.4 Curis Termination for Debiopharm Diligence Failure: If Debiopharm does not
correct a failure to use Reasonable Commercial Efforts within the applicable
period specified in, or determined in accordance with, Section 3.2.6(b) (a
“Diligence Failure”), Curis shall have the right to terminate this Agreement on
thirty (30) days’ written notice to Debiopharm unless Debiopharm cures such
Diligence Failure before the end of such thirty (30) day period.

 

12.5 Termination for Material Breach: Each Party shall have the right to
terminate this Agreement upon ninety (90) days’ (or forty-five (45) days’ in the
case of failure to make payment of amounts due hereunder) prior written notice
to the other Party in the event of the material breach of any term or condition
of this Agreement by the other Party, unless the breaching Party has cured such
breach by the end of the applicable cure period; provided, however, that:

(a) this Section 12.5 shall not apply to: (i) any failure to file an IND or CTA
in a Major Market (in which case, Curis’ termination right shall be as set forth
in Section 12.3); or (ii) any Diligence Failure by Debiopharm (in which case,
Curis’ termination right shall be as set forth in Section 12.4);

(b) any right to terminate under this Section 12.5 shall be stayed and the cure
period shall be stopped in the event that, during any cure period, the Party
alleged to have been in material breach shall have initiated dispute resolution
in accordance with Article 20 with respect to the alleged breach, which stay and
stopping shall last so long as the allegedly breaching Party diligently and in
good faith cooperates in the prompt resolution of such dispute resolution
proceedings; and

(c) from and after initiation of the first Phase III Study of a Product in a
Major Market, except in the case of Debiopharm’s failure to make payments of
amounts due hereunder, Curis shall not have the right to terminate this
Agreement pursuant to this Section 12.5, and, as Curis’ sole remedy for material
breach of this Agreement by Debiopharm that is not cured within sixty (60) days
after Curis’ written notice of material breach, Curis shall have the right to
seek damages from Debiopharm and/or injunctive relief, in each case, in
accordance with Article 20.

 

12.6 Termination for Patent Challenge: Each Party shall have the right to
terminate this Agreement immediately upon written notice to the other Party if
the other Party or its Affiliate directly, or through assistance granted to a
Third Party, challenges, whether as a claim, a cross-claim, counterclaim, or
defense, the validity or enforceability of any of such Party’s Patents before
any court, arbitrator, or other tribunal or administrative agency in any
jurisdiction.

 

13 CONSEQUENCES OF TERMINATION

 

13.1 In the event of (i) termination of this Agreement by Debiopharm pursuant to
Section 12.1, or (ii) termination of this Agreement by Curis pursuant to
Section 12.3, Section 12.4, Section 12.5 (subject to paragraph (c) thereof) or
Section 12.6:

(a) The license granted by Curis to Debiopharm under Section 2.1 shall terminate
and revert to Curis on the effective date of termination.

 

 

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(b) Curis shall have the right, exercisable upon written notice by Curis to
Debiopharm given within sixty (60) days after the effective date of such
termination, to obtain, and effective upon such notice, Debiopharm shall, and it
hereby does, grant to Curis, a non-exclusive, worldwide, royalty-bearing
license, with the right to sublicense, under Debiopharm Intellectual Property
Rights solely to develop, make, have made, use, sell, offer for sale, have sold
and import the Compound and Products in the Field of Use, subject to the terms
and conditions set forth below in this Section 13.1(b).

(i) Curis will pay to Debiopharm royalties at the rate of [**] percent ([**]%)
of Curis Net Sales (defined below) of Products. Royalties on Curis Net Sales
will be payable on a country-by-country basis from first commercial sale of a
Product in a country of the Territory and ending upon the later of:
(a) expiration of the last-to-expire valid claim of the Debiopharm Patents,
which valid claim covers the composition of matter, or any method of manufacture
or use, of the Product (or the Compound contained therein) in such country; and
(b) the tenth (10th) anniversary of first commercial sale of the Product in such
country. For purposes of this Section 13.1(b), the definition of “Net Sales” set
forth in Article 1 shall apply mutatis mutandis to define the term “Curis Net
Sales”.

(ii) Curis shall pay to Debiopharm [**] percent ([**]%) of all Curis Sublicensee
Royalties (defined below). For purposes of this Section 13.1(b), “Curis
Sublicensee Royalties” shall mean royalties paid by Third Party sublicensees to
Curis or any of its Affiliates with respect to sales of Products by such Third
Party sublicensees or any of their respective further sublicensees.

(iii) Royalties on Curis Net Sales shall be paid by Curis to Debiopharm
quarterly within forty-five (45) days after the end of calendar quarter in which
such Curis Net Sales are made (as determined by the date of invoice or billing).
Payments on Curis Sublicensee Royalties shall be paid by Curis to Debiopharm
quarterly within forty-five (45) days after such Curis Sublicensee Royalties are
received by Curis or its Affiliate. If such Curis Sublicensee Royalties are
significantly overdue, then upon Debiopharm’s request, the Parties agree to
discuss the matter in good faith.

(iv) All payments to Debiopharm hereunder shall be made using the bank details
provided by Debiopharm. Royalties on Curis Net Sales and payments on Curis
Sublicensee Royalties shall be made in United States Dollars. If payments of
Curis Net Sales or Curis Sublicensee Royalties are made in another currency than
the United States Dollar, Curis shall convert them into United Sates Dollars for
the purpose of the calculation of royalties on Curis Net Sales and payments on
Curis Sublicensee Royalties by applying the average interbank exchange rate as
published on www.oanda.com for the last day of each month within the calendar
quarter for which payment to Debiopharm is due. All costs associated with making
payments to Debiopharm, including the cost of wire transfers, shall be paid by
Curis and shall not be deducted from the payments to Debiopharm.

(v) Curis shall (and shall require its Affiliates to) prepare and maintain
complete and accurate books and records regarding Curis Net Sales (including
gross sales and applicable deductions from gross sales), royalties payable with
respect

 

 

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thereto, Curis Sublicensee Royalties and payments based thereon for a period of
at least two (2) calendar years after the end of the calendar year in which such
activities occurred. Debiopharm shall have the right to have such books and
records inspected by an independent certified auditor selected by Debiopharm and
accepted by Curis, whose acceptance shall not be unreasonably withheld, to
confirm Curis Net Sales (including gross sales and applicable deductions from
gross sales), royalties payable with respect thereto, Curis Sublicensee
Royalties and payments based thereon, for a period covering not more than the
preceding two (2) calendar years. Such auditor will execute a reasonable written
confidentiality agreement with Curis and will disclose to Debiopharm only such
information as is reasonably necessary to provide Debiopharm with information
regarding any actual discrepancies between the amounts reported or paid and the
amounts payable under this Agreement. Such auditor will send a copy of its
report to Curis within fifteen (15) days of delivery of such report to
Debiopharm. Such report will include the methodology and calculations used to
determine the results. Prompt adjustments shall be made by the Parties to
reflect the results of such audit. Records to be available under an inspection
shall include all relevant documents pertaining to payments specified above,
including all relevant documents received by Curis from Sublicensees. The
appointed auditor shall have the right to interview selected staff and copy
relevant documents. Such right may be exercised by Debiopharm only once per
calendar year. Debiopharm shall bear the fees and expenses of such inspection,
provided that, if an underpayment of more than five percent (5%) of the payments
due for any calendar year is discovered in any inspection, then Curis shall bear
all fees and expenses of that inspection within forty-five (45) days after
receipt of invoice from Debiopharm, and shall pay to Debiopharm within
forty-five (45) days after receipt of the auditor’s report the deficiency not
previously paid, plus accrued interest on the underpayment at the floating rate
of LIBOR [**] (as quoted in The Wall Street Journal or its successor on the day
after the payment is due) calculated from the due date to the date paid in full.

(vi) Without limiting any other rights or remedies available to Debiopharm,
Curis shall pay Debiopharm interest on any payments that are not paid on or
before five (5) working days from the due date at the floating rate of LIBOR
[**] (as quoted in The Wall Street Journal or its successor on the day after the
payment is due) calculated from the due date to the date paid in full.

(vii) In the event Curis fails to pay overdue amounts to Debiopharm by the due
date specified in this Section 13.1(b), Debiopharm shall have the right to
terminate Curis’ license under Section 13.1(b) upon forty-five (45) days’ prior
written notice to Curis, unless Curis has cured such failure to pay by the end
of such forty-five (45-) day period.

(viii) Curis shall make payments to Debiopharm under this Agreement withholding
any taxes that may be due with respect to such payments to the extent that such
withholding is required by applicable law. If any taxes are required to be
withheld by Curis, then Curis shall (a) deduct such taxes from the payment made
to Debiopharm, (b) timely pay the taxes to the proper taxing authority, and
(c) send proof of payment to Debiopharm and certify receipt of such payment by
the applicable tax authority within sixty (60) days following such payment.

(c) If Curis chooses to obtain the non-exclusive license under Section 13.1(b),
Debiopharm shall (A) transfer to Curis as soon as reasonably

 

 

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practicable all Data and information in Debiopharm’s or its Affiliates’ Control
and possession relating to the Compound or Products as may be necessary to
enable Curis to practice such license, (B) transfer and assign to Curis all of
its right, title and interest in and to all INDs, NDAs, drug dossiers and master
files with respect to any and all Products and all regulatory approvals with
respect to any and all Products, and (C) take such other actions and execute
such other instruments, assignments and documents as may be necessary to effect
the transfer of rights under this subparagraph (c) to Curis.

 

13.2 In the event of termination of this Agreement by Debiopharm in a country in
the Territory pursuant to Section 7.1.3 or Section 12.2, the license granted by
Curis to Debiopharm under Section 2.1 in such country shall terminate and revert
to Curis on the effective date of termination, the Territory shall thereafter
exclude such country, and this Agreement shall otherwise remain in full force
and effect.

 

13.3 Consequences of Termination for Curis’ Material Breach:

For purposes of this Section 13.3, the term “Termination Event” shall mean:
(a) in the case of termination of this Agreement by Debiopharm pursuant to
Section 12.5, the material breach of this Agreement by Curis that formed the
basis for such termination; or (b) in the case of termination of this Agreement
pursuant to Section 12.6, the action or activity of Curis that that formed the
basis for such termination.

 

13.3.1 Aggravated Termination Event: In the event of termination of this
Agreement by Debiopharm pursuant to Section 12.5 or Section 12.6 for an
Aggravated Termination Event (defined below), Curis grants to Debiopharm a
royalty-free, sole and exclusive license (even as to Curis) in and to the
Compound and the Product under the Curis Intellectual Property Rights and Curis’
interest in the Joint Patents, to develop, have developed, use, have used, sell,
have sold, offer for sale, make, have made, manufacture, have manufactured,
register, have registered, commercialize and have commercialized the Compound
and Products, in any Indication in the Field of Use, for the Royalty Term, in
the Territory. Upon expiration of the Royalty Term, Section 11.2 shall apply.
For purposes of this Section 13.3, an “Aggravated Termination Event” shall mean
a Termination Event that is not curable and results in significant negative
impact upon Debiopharm’s ability to commercialize Products. By way of example,
and not of limitation, a material breach of [**] would each be considered an
Aggravated Termination Event. A Termination Event other than the preceding
examples may also qualify as an Aggravated Termination Event if the magnitude of
the impact of such Termination Event upon Debiopharm’s ability to commercialize
Products is substantially equivalent to, or greater than, that of the preceding
examples.

 

13.3.2 Other Termination Event: In the event of termination of this Agreement by
Debiopharm pursuant to Section 12.5 or Section 12.6 for any Termination Event
other than an Aggravated Termination Event:

(a) the license granted by Curis to Debiopharm pursuant to Section 2.1 remain in
full force and effect in accordance with its terms, subject to Debiopharm’s
compliance with Article 6;

(b) all JSC participation rights of Curis shall terminate and be of no further
force or effect;

 

 

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(c) Debiopharm shall have the right to seek damages from Curis in accordance
with Article 20; and

(d) pending the outcome of arbitration proceedings pursuant to Article 20,
Debiopharm shall have the right to pay all amounts that become due under Article
6 after such termination into an escrow account with a reputable bank, and to
the extent the arbitrators award damages to Debiopharm, the arbitrators shall be
authorized, in their discretion, (i) to cause the release to Debiopharm of all
or any part of the escrowed funds in partial or full satisfaction of such award,
and/or (ii) to adjust the amounts payable by Debiopharm to Curis under this
Agreement to compensate Debiopharm for damages suffered by Debiopharm as a
result of Curis’ material breach.

 

13.4 In the event of termination of this Agreement in its entirety by Debiopharm
pursuant to Section 7.1.3, the license granted by Curis to Debiopharm under
Section 2.1 shall terminate and revert to Curis on the effective date of
termination.

 

13.5 Any termination of this Agreement shall be without prejudice to any rights
or obligations which have accrued to any Party prior to such termination.
Without limiting the generality of the foregoing, termination of this Agreement
shall not preclude either Party from claiming any other damages, compensation or
relief that it may be entitled to hereunder.

 

13.6 The license granted to Debiopharm under this Agreement will be deemed a
license of rights to intellectual property for purposes of Section 365(n) of the
U.S. Bankruptcy Code, and, in the event of Curis’ bankruptcy, Debiopharm will
retain and may fully exercise all of its rights and elections under the U.S.
Bankruptcy Code.

 

14 NON COMPETITION

 

14.1 Curis agrees not to develop in parallel an Hsp90 Inhibitor (or product
containing an Hsp90 Inhibitor) and which is in competition to the Compound or
Product because of its ability to bind to, and selectively and specifically
inhibit, Hsp90. [**].

 

14.2 Such obligations in favor of Debiopharm under Section 14.1 shall not
survive an early termination of this Agreement except in the case of any
material breach by Curis, in which case they shall survive for two (2) years
after termination of this Agreement.

 

15 SURVIVING PROVISIONS

Sections 6.7, 8.4 and 11.2 and Articles 1, 9, 10, 13, 14 (as set forth in
Section 14.2), 15, 16, 18, 19, 20 and 22 shall survive termination or expiration
of this Agreement. In addition, if the license granted to Debiopharm under
Section 2.1 survives termination as set forth in Section 13.3, Sections 6.3,
6.4, 6.5 and 6.6 shall survive such termination.

 

16 NOTICES

Notices required or permitted to be made or given to either Party hereto
pursuant to this Agreement shall be sufficiently made or given on the date of
mailing if sent to such Party by certified or registered mail, postage prepaid,
addressed to it at its address set forth or to such other address as it shall
designate in the course of this Agreement by written notice to the other Party
as follows:

If to Curis:

Curis, Inc.

45 Moulton Street

Cambridge, MA 02138

USA

Attention: Chief Executive Officer

 

 

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If to Debiopharm:

Debiopharm S.A.

Forum «après-demain»

Chemin Messidor 5-7

1006 Lausanne

Switzerland

Attention: Director, Legal Affairs

 

17 INDEPENDENT CONTRACTOR

The relationship of Debiopharm and Curis under this Agreement is intended to be
that of an independent contractor. Nothing contained in this Agreement is
intended or is to be construed so as to constitute the Parties as partners or
joint venturers or either Party as an agent or employee of the other. Neither
Party has any express or implied right or authority under this Agreement to
assume or create any obligations on behalf of or in the name of the other, or to
bind the other Party to any contract, agreement or undertaking with any Third
Party.

 

18 COMPLETE AGREEMENT

The Parties hereto acknowledge that this Agreement sets forth the entire
agreement and understanding of the Parties, and supersedes all prior written or
oral agreements or understandings with respect to the subject matter hereof,
including material transfer agreements, if any, and that certain “Addendum to
the Confidentiality Agreement dated June 18, 2007,” dated and effective as of
August 20, 2008 (the “First Addendum”); but, in any event, excluding:

(a) that certain Confidentiality Agreement between the Parties dated June 18,
2007 (the “Original Confidentiality Agreement”), which shall remain in full
force and effect in accordance with its terms; provided, however, that all
“Confidential Information” (as defined by the Original Confidentiality
Agreement) of Curis relating to its single targeted Hsp90 Inhibitor programs,
including, without limitation, CUDC-305, shall be deemed Confidential
Information for purposes of this Agreement; and

(b) that certain “Second Addendum to the Confidentiality Agreement dated
June 18, 2007,” dated and effective as of June 11, 2009 (the “Second Addendum”),
which shall remain in full force and effect in accordance with its terms;
provided, however, that [**] for purposes of this Agreement.

 

 

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In the event of any conflict between the provisions of this Agreement and the
provisions of the Original Confidentiality Agreement or the Second Addendum,
this Agreement shall control. No modification of this Agreement shall be deemed
to be valid unless in writing and signed by both Parties.

 

19 ASSIGNMENT

Except as expressly provided hereunder, neither this Agreement nor any rights or
obligations hereunder may be assigned or otherwise transferred by either Party
without the prior written consent of the other Party (which consent shall not be
unreasonably withheld); provided, however, that either Party may assign this
Agreement and its rights and obligations hereunder without the other Party’s
consent:

 

  (a) in connection with the transfer or sale of all or substantially all of the
business of such Party to which this Agreement relates to a Third Party, whether
by merger, sale of stock, sale of assets or otherwise (each, a “Change of
Control Transaction”), provided that in the event of a Change of Control
Transaction in which the acquiring party is a Third Party, intellectual property
rights of the acquiring party to such Change of Control Transaction that exist
prior to the effective time of such Change of Control Transaction or result from
an Acquiror Existing Hsp90 Program (as defined in Section 14.1) shall not be
included in the technology licensed hereunder or otherwise subject to this
Agreement; or

 

  (b) to an Affiliate, provided that no such assignment to an Affiliate shall
relieve the assigning Party of its obligations hereunder.

The rights and obligations of the Parties under 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 void.

 

20 GOVERNING LAW AND DISPUTE RESOLUTION

 

20.1 Except as expressly set forth in Section 20.6, this Agreement shall be
governed by the laws of England and Wales.

 

20.2 The Parties agree that, except as set forth in Section 20.6 below, the
procedures set forth in Sections 20.3 through 20.5 shall be the exclusive
mechanism for resolving any dispute, disagreement, controversy or claim arising
under, out of or relating to this Agreement and any subsequent amendments of
this Agreement, including, without limitation, its formation, validity, binding
effect, interpretation, performance, breach or termination, as well as non
contractual claims arising out of the subject matter of this Agreement
(“Dispute”).

 

20.3 Any Dispute shall be submitted to the appropriate executive officers of the
Parties by written notice prior to initiation of any action under Sections 20.4
and 20.5. Such executive officers shall attempt resolution of the Dispute by
good faith negotiation for a period of thirty (30) days from written notice of
the Dispute by either Party. Each Party shall appoint one executive officer for
such negotiation.

 

20.4

If the Parties are unable to resolve a Dispute pursuant to Section 20.3 within
sixty (60) days of referring such Dispute to their executive officers, then,
upon the written request

 

 

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of either Party to the other Party, the Parties shall submit the Dispute for
commercial mediation in accordance with the then-applicable ADR Rules of the
International Chamber of Commerce (“ICC”). Such mediation will take place in
London, England. If there is no agreement as to the selection of such a mediator
within twenty (20) days of written request for mediation by either Party or the
Dispute is not resolved by the Parties with the assistance of such a mediator
within sixty (60) days of the matter being referred to him/her, then the Dispute
shall be settled by arbitration as set out in Section 20.5.

 

20.5 If the Dispute is not settled under Section 20.3 and Section 20.4, then,
upon the written request of either Party to the other Party, the dispute shall
be resolved by arbitration before a panel of three (3) arbitrators with relevant
pharmaceutical industry experience in accordance with the then-applicable
arbitration rules of the ICC. One arbitrator shall be chosen by Debiopharm and
one arbitrator shall be chosen by Curis within fifteen (15) days from such
written request for initiation of arbitration. The third arbitrator shall be
chosen by mutual agreement of the arbitrators selected by the Parties within
fifteen (15) days of the date that the last of the arbitrators selected by the
Parties was appointed. The arbitrators shall be instructed to establish a
timeline and other parameters for the conduct of discovery and the arbitration
hearing that will reasonably expedite resolution of the Dispute. The arbitration
proceedings shall take place in London, England, and both the arbitration
proceedings and the arbitrators’ ruling shall be in the English language. In
making their decision, the arbitrators shall apply the laws of England and
Wales. The arbitrators shall, within fifteen (15) calendar days after the
conclusion of the arbitration hearing, issue a written award and statement of
decision describing the essential findings and conclusions on which the award is
based, including the calculation of any damages awarded. The decision or award
rendered by the arbitrators shall be final and non-appealable, and judgment may
be entered upon it in any court of competent jurisdiction. Each Party shall bear
its own attorney’s fees, costs, and disbursements arising out of the
arbitration, and shall pay an equal share of the fees and costs of the
arbitrators; provided, however, that the arbitrators shall be authorized to
determine whether a Party is the prevailing party, and if so, to award to that
prevailing party reimbursement for any or all of its reasonable attorneys’ fees,
costs and disbursements (including, for example, expert witness fees and
expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs
of the ICC and the arbitrators.

 

20.6 Notwithstanding the foregoing provisions of this Article 20, disputes
pertaining to the validity, construction, scope, enforceability, infringement or
other violations of patents or other proprietary or intellectual property rights
shall be resolved solely by a court or patent office of competent jurisdiction,
and no such claim shall be subject to mediation or arbitration pursuant to this
Article 20. In addition, nothing contained in this Agreement shall deny either
Party the right to seek injunctive or other equitable relief from a court of
competent jurisdiction in the context of a bona fide emergency or prospective
irreparable harm, and such an action may be filed and maintained notwithstanding
any ongoing mediation or arbitration proceeding.

 

21 FORCE MAJEURE

 

21.1 Neither Party shall be liable for a failure to comply with a provision
herein, if it is prevented from performing the said provision because of force
majeure, this notion being defined as an event beyond the control of the Parties
and independent from their will including, but not limited to, strikes or other
labor trouble, war, insurrection, fire, flood, explosion, discontinuity in
supply of power, court order or governmental interference.

 

 

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21.2 Despite the event of force majeure, either Party hereto shall undertake
reasonable efforts to comply to the extent possible with its obligations towards
the other Party, pursuant to this Agreement.

 

21.3 The Party invoking an event of force majeure shall notify it forthwith to
the other Party, and must specify which one or ones of its obligations it is
being prevented from complying with, and the nature of force majeure, and must
give an estimate of the period during which it is likely that it shall be
prevented from complying with the said obligation or obligations.

 

22 MISCELLANEOUS

 

22.1 If any provision of this Agreement should be or become fully or partly
invalid or unenforceable for any reason whatsoever or should violate any
applicable law, this Agreement is to be considered divisible as to such
provision and such provision is to be deemed deleted from this Agreement, and
the remainder of this Agreement shall be valid and binding as if such provision
were not included therein. There shall be substituted for any such provision
deemed to be deleted a suitable provision which, as far as is legally possible,
comes nearest to the sense and purpose of the stricken provision.

 

22.2 Failure by any Party to enforce any term or provision of this Agreement in
any specific instance or instances hereunder shall not constitute a waiver by
such Party of any such term or provision, and such Party may enforce such term
or provision in any subsequent instance without any limitation or penalty
whatsoever.

 

22.3 This Agreement is neither expressly nor impliedly made for the benefit of
any entity other than the Parties.

 

22.4 The headings set forth in this Agreement are for convenience only and do
not qualify or affect the terms or conditions of this Agreement. Ambiguities and
uncertainties in this Agreement, if any, shall not be interpreted against either
Party, irrespective of which Party may be deemed to have caused the ambiguity or
uncertainty to exist. This Agreement has been prepared in the English language,
and the English language shall control its interpretation. In addition, all
notices required or permitted to be given hereunder, and all written,
electronic, oral or other communications between the Parties regarding this
Agreement shall be in the English language.

 

22.5 No waiver of any right or remedy hereunder shall be effective unless
provided in writing executed by the waiving Party.

 

22.6 This Agreement may be executed in two (2) counterparts, each of which shall
be deemed an original document, and which shall be deemed one instrument.

 

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.

 

DEBIOPHARM S.A.:     CURIS, INC.:

/s/ Dr. Rolland-Yves Mauvernay

   

/s/ Daniel R. Passeri

Dr. Rolland-Yves Mauvernay     Name:   Daniel R. Passeri President       Title:
  President & CEO Date:  

    6/08/2009

    Date:  

        August 5, 2009

       

 

EXHIBIT 1:   Compound EXHIBIT 2:   Curis Patents EXHIBIT 3:   Development Plan
EXHIBIT 4:   Technology Transfer Plan

 

 

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EXHIBIT 1

Compound

Chemical structure of CUDC-305

2-(6-(Dimethylamino)
benzo[d][1,3]dioxol-5-ylthio)-1-(2-(neopenthylamino)ethyl)-1H-imidazo[4,5-c]
pyridine-4-amine

LOGO [g10165ex10_1pg42.jpg]

 

 

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EXHIBIT 2

Curis Patents

 

Patent Application

Number

  Country   Filing   Status

CUDC-305 – Hsp90 inhibition

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

       

[**]

 

 

[**]

 

 

[**]

 

 

[**]

 

 

 

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EXHIBIT 3

Development Plan

CUDC-305 DEVELOPMENT up to Phase IIa Study

 

Task   Estimated start   Estimated end [**]   [**]   [**] [**]   [**]   [**]
[**]   [**]   [**] [**]   [**]   [**] [**]   [**]   [**] [**]   [**]   [**] [**]
  [**]   [**] [**]   [**]   [**] [**]   [**]    

 

 

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EXHIBIT 4

Technology Transfer Plan

Curis’ Responsibilities under the Technology Transfer Plan are as follows:

(a) Transfer of Information. As soon as possible but in any event within 30 days
of the Effective Date, Curis shall provide Debiopharm with information existing
as of the Effective Date and in Curis’ possession that is reasonably considered
to be (whether or not Confidential Information) necessary for the research,
development and manufacturing of the Product, without limitation, information
relating to the chemical or molecular structure, synthesis route, manufacturing,
formulation, preclinical data (e.g., PK, ADME and toxicology), records of
interactions with regulatory authorities, drafts of regulatory filings, drafts
of clinical protocols and reports on the Product within the scope of the
licenses granted to Debiopharm under the Agreement (the “Technology Transfer
Information”).

(i) [**]

(b) Transfer of GMP Materials. Curis shall transfer GMP and non-GMP materials as
requested by Debiopharm in accordance with Section 3.1.1 of the Agreement.

(c) Curis Support of Development Plan. Curis shall provide a reasonable amount
of ongoing support to Debiopharm’s performance of the Development Plan for a
period of six (6) months from the Effective Date, in accordance with
Section 3.1.2 of the Agreement.

(d) Technology Transfer Management. The Debiopharm employees who are designated
by Debiopharm to receive such Technology Transfer Information and materials
(each, a “Designated Debiopharm Recipient”) are [**] (“Designated Debiopharm
Alliance Manager”) and [**] (“Designated Debiopharm Project Manager”).
Debiopharm may replace any or all of such Designated Debiopharm Recipients at
any time upon prior written notice to the Curis alliance manager (“Designated
Curis Alliance Manager”). The Designated Curis Alliance Manager shall be [**],
Curis, Inc., 45 Moulton Street, Cambridge, MA 02138 USA; [**].

 

 

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