Exhibit 10.20

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

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LICENSE AGREEMENT

 

This license agreement (the “Agreement”) is effective as of February __, 2015
(the “Effective Date”) by and among ACTELION PHARMACEUTICALS, LTD., a Swiss
company located at Gewerbestrasse 16, CH-4123 Allschwil, Switzerland
(“Actelion”), KYTHERA HOLDINGS, LTD., a Bermuda company located at Clarendon
House, 2 Church Street, Hamilton HM 11, Bermuda (“Kythera”), and KYTHERA
BIOPHARMACEUTICALS, INC., a Delaware company located at 30930 Russell Ranch
Road, 3rd Floor, Westlake Village, CA 91362, United States of America (“KBI”). 
Actelion, Kythera and KBI (but only with respect to section 12.5) are referred
to individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

A.           Actelion is a multinational biopharmaceutical company that has
discovered and developed small molecule antagonists to the target known as
CRTH2, including the compound known as setipiprant.

 

B.           Kythera is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of novel prescription products
for the aesthetic medicine market.

 

C.           Kythera and Actelion desire to enter into an agreement under which
Actelion would grant to Kythera a license under certain technology and
intellectual property rights controlled by Actelion covering Actelion’s CRTH2
antagonists for the development and commercialization of products including such
compounds.

 

NOW, THEREFORE, the Parties agree as follows:

 

1.                                    DEFINITIONS

 

Capitalized terms used in this Agreement (other than the headings of the
Sections or Articles) have the following meanings set forth in this Article 1,
or, if not listed in this Article 1, the meanings as designated in the text of
this Agreement.

 

1.1         “Actelion Licensed Know-How” means all Information (other than
Patents) that is Controlled by Actelion or its Affiliates, as of the Effective
Date, and that: (a) relates to compositions of matter, methods of use,
formulations of, methods of manufacture of, or companion diagnostics for,
Compounds; (b) is not generally known; and (c) is necessary or reasonably useful
for Kythera to develop setipiprant for hair growth or the prevention of hair
loss.

 

1.2         “Actelion Licensed Patents” means all Patents that are listed on
Exhibit 1.2.

 

1.3         “Actelion Related Patents” means all Patents that: (a) are conceived
or developed by (or on behalf of) Actelion prior to the Effective Date; (b) are
not listed on Exhibit 1.2, (c) have been filed before, or will be filed after,
the Effective Date; and (d) claim inventions that relate to compositions of
matter, methods of use, formulations of, methods of manufacture of, or companion
diagnostics for, Compounds.

 

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1.4         “Affiliate” means, with respect to a Party, a person, corporation,
partnership, or other entity that now or hereinafter controls, is controlled by
or is under common control with such Party.  For the purposes of the definition
in this Section 1.4, the word “control” (including, with correlative meaning,
the terms “controlled by” or “under the common control with”) means the actual
power, either directly or indirectly through one (1) or more intermediaries, to
direct or cause the direction of the management and policies of such entity,
whether by the ownership of at least fifty percent (50%) of the voting stock of
such entity, by contract or otherwise.

 

1.5         “ANDA” means an abbreviated new drug application submitted to the
FDA in conformance with applicable laws and regulations, or the foreign
equivalent of any such application in any other country.

 

1.6         “Commercialize” means to promote, market, import, distribute, sell
(and offer for sale or contract to sell) or provide product support for a
Licensed Product, including by way of example: (a) detailing and other
promotional activities in support of a Licensed Product; (b) advertising and
public relations in support of a Licensed Product, including market research,
development and distribution of selling, advertising and promotional materials,
field literature, direct-to-consumer advertising campaigns, media or journal
advertising, and exhibiting at seminars and conventions; (c) developing
reimbursement programs and information and data specifically intended for
national accounts, managed care organizations, governmental agencies (e.g.,
federal, state and local), and other group purchasing organizations, including
pull-through activities; (d) co-promotion activities not included in the above;
and (e) conducting Phase IV Clinical Trials.

 

1.7         “Commercially Reasonable Efforts” means the effort customarily
exerted by a Party with respect to its own products of similar nature and
commercial potential, taking into account, by example and without limitation,
such factors as intellectual property position, the cost of development,
regulatory risk, safety and efficacy, reimbursement factors, parallel
importation considerations, pricing, product life cycle and cost of sales and
marketing, and also including the timing and promptness with which such efforts
and resources would be applied.

 

1.8         “Compendia Listing” means a listing for an indication in the United
States for a Licensed Product that is supported by a citation in at least one of
the following authoritative drug reference books: (a) the American Society of
Health-System Pharmacists’ American Hospital Formulary Service (AHFS); or
(b) the U.S. Pharmacopoeia Drug Information, or in another similar authoritative
drug reference book that is relied on by Third Party payors in authorizing
reimbursement for such Licensed Product for such indication.

 

1.9         “Compounds” means: (a) Actelion’s compound known either as
setipiprant or ACT-129968; (b) all other compounds [***]; and (c) the [***] of
the compounds described in (a) and/or (b).

 

1.10      “Controlled” means, with respect to any physical material, Information
or intellectual property right, that the Party owns or has a license to such
physical material, Information or intellectual property right and has the
ability to grant to the other Party access, a license or a sublicense (as
applicable) to such physical material, Information or intellectual property
right as provided for herein without violating the terms of any agreement or
other arrangements

 

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with any Third Party existing at the time such Party would be first required
hereunder to grant the other Party such access, license or sublicense.

 

1.11      “CRTH2” means: (a) the gene encoding the chemoattractant
receptor-homologous molecule expressed on Th2 cells for any species (which
molecule is also known as GPR44 or DP2); (b) the protein encoded by such gene;
and (c) all [***] thereof.

 

1.12      “CRTH2 Antagonists” means any molecule with a [***] antagonizing
CRTH2.

 

1.13      “Development” means, with respect to a Licensed Product, those
activities, including clinical trials and related regulatory activities, that
are necessary or useful to: (a) obtain the approval by the applicable Regulatory
Authorities of the Regulatory Approval Application with respect to such Licensed
Product in the applicable regulatory jurisdiction, whether alone or for use
together, or in combination, with another active agent or pharmaceutical
product; (b) maintain such approvals; or (c) obtain or maintain Compendia
Listings with respect to such Licensed Product.  To avoid confusion, Development
does not include the conduct of Research or Phase IV Clinical Trials.

 

1.14      “Dollars” or “$” means the legal tender of the United States.

 

1.15      “Executive Officers” means: (a) in the case of Actelion, the EVP and
Chief Business Development Officer, or that officer’s designee; and (b) in the
case of Kythera, the Vice President for Strategy and Corporate Development, or
that officer’s designee.

 

1.16      “FDA” means the U.S. Food and Drug Administration, and any successor
thereto.

 

1.17      “Field” means any and all uses (including therapeutic, diagnostic or
prophylactic uses) in humans and other vertebrates.

 

1.18      “First Commercial Sale” means, for each Licensed Product in each
country, the first arm’s-length sale to a Third Party for use or consumption by
the public of such Licensed Product in such country after Regulatory Approval of
such Licensed Product in such country.  A First Commercial Sale will not include
any Licensed Product supplied for use in clinical trials, for research or for
other non-commercial uses, or as part of a compassionate use program (or similar
program for providing Licensed Product before it has received Regulatory
Approval in a country).

 

1.19      “Generic Licensed Product” means, with respect to a particular
Licensed Product in a country, a pharmaceutical product that: (a) contains the
same Compound as such Licensed Product; and (b) is approved for use in such
country pursuant to 21 U.S.C. 355(b)(2), an ANDA, a separate NDA, Compendia
Listing, or equivalent drug approval application.

 

1.20      “IND” means an investigational new drug application submitted to the
FDA in conformance with applicable laws and regulations, or the foreign
equivalent of any such application in any other country.

 

1.21      “Information” means information, materials, results and data of any
type, in any tangible or intangible form, including, preclinical data, clinical
trial data, databases, practices, methods, techniques, specifications,
formulations, formulae, knowledge, know-how, skill,

 

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experience, test data including pharmacological, biological, chemical,
biochemical, toxicological and clinical materials, test data, analytical and
quality control data, stability data, studies and procedures.  For
clarity, Information does not include any Patents.

 

1.22      “Invention” means any and all inventions or improvements that are
conceived or made by or on behalf of a Party (or its Affiliates) in the
performance of its obligations, or the exercise of its rights, under this
Agreement.

 

1.23      “Joint Invention” means any Invention conceived or made jointly by or
on behalf of the employee(s), contractor(s) or agent(s) of both Parties (or
their Affiliates).

 

1.24      “Licensed Product” means any product preparation in final form that
contains one or more Compounds

 

1.25      “Major European Countries” means [***].

 

1.26      “Manufacturing” means all activities related to the production,
manufacture, processing, filling, finishing, packaging, labeling, inspection,
receiving, holding and shipping of Compounds, Licensed Products, or any raw
materials or packaging materials with respect thereto, or any intermediate of
any of the foregoing, including process and cost optimization, process
qualification and validation, clinical manufacture, commercial manufacture,
stability and release testing, quality assurance and quality control.

 

1.27      “Manufacturing Information” means all Information that is Controlled
by Actelion or its Affiliates as of the Effective Date and/or during the Term,
that is related to the Manufacturing of Compounds and Licensed Products, and
that is reasonably necessary or useful to enable Kythera or a Third Party
manufacturer selected by Kythera (as appropriate) to Manufacture Compounds.

 

1.28      “Materials” means Compounds in the possession of Actelion.

 

1.29      “NDA” means a new drug application submitted to the FDA in conformance
with applicable laws and regulations, or the foreign equivalent of such
application in any other country.

 

1.30      “Net Sales” means the gross amount received by Kythera (or its
Affiliate, licensee or sublicensee) for sales of a Licensed Product to a Third
Party purchaser, less the following to the extent included in such invoice or
otherwise actually allowed or incurred with respect to such sales:
(a) discounts, including cash, trade and quantity discounts, price reduction
programs, retroactive price adjustments with respect to sales of a Licensed
Product, charge-back payments and rebates granted to managed health care
organizations or to federal, state and local governments (or their respective
agencies, purchasers and reimbursers) or to trade customers, including but not
limited to, wholesalers and chain and pharmacy buying groups; (b) credits or
allowances for rejections or returns of Licensed Products, including for recalls
or damaged goods; (c) freight, postage, shipping and insurance charges for
delivery of Licensed Products, to the extent billed; and (d) taxes, duties or
other governmental charges levied on, absorbed or otherwise imposed on sale of
Licensed Products, including value-added taxes, or other governmental charges
otherwise measured by the billing amount, when included in billing, as adjusted
for rebates and refunds, but specifically excluding taxes based on net income of
the seller; provided that all of the foregoing deductions are calculated in
accordance with US GAAP.

 

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For sake of clarity and avoidance of doubt, sales by Kythera (or its Affiliate,
licensee or sublicensee) of a Licensed Product to a Third Party distributor of
such Licensed Product in a given country will be considered a sale to a Third
Party purchaser.  Any Licensed Products used (but not sold for consideration)
for promotional or advertising purposes (including free samples), or used for
clinical or other research purposes, will not be considered in determining Net
Sales hereunder.

 

If a Licensed Product is sold as a combined product or service, Net Sales, for
purposes of determining royalty payments on such Licensed Product, will be
calculated by multiplying the Net Sales of the combined product or service by
the fraction A/A+B, in which A is the gross selling price (in the applicable
country) of the Licensed Product portion of combined product or service when
such Licensed Product is sold separately during the applicable accounting period
in which the sales of the combined product were made, and B is the gross selling
price (in the applicable country) of the other products or services, as the case
may be, of the combined product and/or service sold separately during the
accounting period in question.  All gross selling prices of the components of
the combined product or service will be calculated as the average gross selling
price of the components during the applicable accounting period for which the
Net Sales are being calculated.

 

In any country, if no separate sale of either such above-designated Licensed
Product or such above designated elements of the end-user product and/or service
are made during the accounting period in which the sale was made, or if gross
retail selling price for an active functional element, component or service, as
the case may be, cannot be determined for an accounting period, Net Sales
allocable to the Licensed Product in each such country will be determined by
mutual agreement reached in good faith by the Parties prior to the end of the
accounting period in question based on an equitable method of determining same
that takes into account, on a country-by-country basis, variations in potency,
the relative contribution of each active agent, component or service, as the
case may be, in the combination, and relative value to the end user of each
active agent, component or service, as the case may be.

 

1.31      “Patent” means all: (a) unexpired patents (including inventor’s
certificates and utility models), including any substitution, extension,
registration, confirmation, reissue, re-examination, restoration, supplementary
protection certificates, confirmation patents, patent of additions, renewal or
any like filing thereof; (b) pending applications for letters patent, including
any continuation, division or continuation-in-part thereof and any provisional
or other priority applications; and (c) any international counterparts, and
counterparts in any country, to clauses (a) and (b) above.

 

1.32      “Phase I Clinical Trial” means a human clinical trial in any country
that would satisfy the requirements of 21 CFR 312.21(a).

 

1.33      “Phase II Clinical Trial” means a human clinical trial in any country
that would satisfy the requirements of 21 CFR 312.21(b).

 

1.34      “Phase IIb Clinical Trial” means a human clinical trial that is
conducted on sufficient numbers of patients and that is designed to provide a
preliminary determination of safety and efficacy of a Licensed Product in the
target patient population over a range of doses and dose regimens.  For
clarification, the Proof of Concept Trial planned by Kythera to study the use of
the Licensed Product to treat alopecia is not a Phase IIb Clinical Trial.

 

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1.35      “Phase III Clinical Trial” means a human clinical trial in any country
that would satisfy the requirements of 21 CFR 312.21(c).

 

1.36      “Phase IV Clinical Trial” means a product support clinical trial of a
Licensed Product commenced after receipt of Regulatory Approval in the country
where such trial is conducted.  A Phase IV Clinical Trial may include
epidemiological studies, modeling and pharmacoeconomic studies, postmarketing
commitments required by health authorities (preclinical, CMC, clinical or other)
and investigator-sponsored clinical trials studying Licensed Product that are
approved by Kythera and that otherwise fit the foregoing definition.

 

1.37      “Proof of Concept Trial” means a Phase II Clinical Trial of a Licensed
Product demonstrating that such Licensed Product is: (a) [***]; and (b) [***] to
progress to a Phase IIb Clinical Trial or a Phase III Clinical Trial.

 

1.38      “Regulatory Approval” means any and all approvals (including
Regulatory Approval Applications, supplements, amendments, pre- and
post-approvals, pricing and reimbursement approvals, where applicable),
licenses, registrations or authorizations of any Regulatory Authority that are
necessary for the manufacture, distribution, use or sale of a Licensed Product
in a regulatory jurisdiction.

 

1.39      “Regulatory Approval Application” means: (a) in the United States, an
NDA (or a supplemental NDA); and (b) in any other country or regulatory
jurisdiction, an equivalent application for regulatory approval required before
commercial sale or use of a Licensed Product (or with respect to a subsequent
indication) in such country or regulatory jurisdiction.

 

1.40      “Regulatory Authority” means the applicable national (e.g., the FDA),
supra-national (e.g., the European Commission), regional, state or local
regulatory agency, department, bureau, commission, council or other governmental
entity that, in each case, governs the approval of a Licensed Product in such
applicable regulatory jurisdiction.

 

1.41      “Research” means any non-clinical research, including the following
activities: (a) identifying molecules as potential CRTH2 Antagonists;
(b) conducting a lead optimization program to optimize such potential CRTH2
Antagonists (including the conduct of medicinal chemistry; biochemical and
cellular assays; in vitro profiling of absorption, distribution, metabolism, and
excretion; structural biology; preliminary pharmacokinetic studies; and
preliminary pharmacodynamic studies); and (c) conducting preclinical development
on such CRTH2 Antagonists to prepare them for IND submission (including the
conduct of toxicological studies, and related bioanalytical and pharmacokinetic
activities).  To avoid confusion, Research excludes the conduct of Development.

 

1.42      “Sole Invention” means any Invention conceived or made solely by or on
behalf of a Party (or its Affiliate) and its employees, contractors and/or
agents.

 

1.43      “Territory” means the world.

 

1.44      “Third Party” means any entity other than: (a) Actelion; (b) Kythera;
or (c) an Affiliate of either Party.

 

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

 

1.46      “US GAAP” means U.S. generally accepted accounting principles,
consistently applied.

 

1.47      “Valid Claim” means a claim in an issued Actelion Licensed Patent
(including a claim under patent term extensions, supplementary protection
certificates or the like) that has not: (a) expired or been canceled; (b) been
declared invalid by an unreversed and unappealable or unappealed decision of a
court or other appropriate body of competent jurisdiction; (c) been admitted to
be invalid or unenforceable through reissue, disclaimer or otherwise; or
(d) been abandoned in accordance with or as permitted by the terms of this
Agreement or by mutual written agreement of the Parties.

 

Additional Definitions

 

The following table identifies the location of definitions set forth in various
Sections of the Agreement.

 

Definition

 

Location (Section)

Actelion FTO Patents

6.1(d)

Actelion Sole Invention Patents

8.1(b)

Actelion Technology

2.1

CMC

11.2(i)

Confidential Information

9.1

Disputed Matter

13.1(a)

force majeure

13.6

Indemnitee

12.3

Insolvent Party

10.2(b)

Joint Invention Patents

8.1(b)

Joint Research Agreement

8.1(d)

Kythera Prosecuted Patents

8.3(a)(i)

Kythera Sole Invention Patents

8.1(b)

Liaison

2.3(a)

Losses

12.1

Prior CDA

9.4

Rules

13.1(b)

Term

10.1

 

2.                                    TRANSFER OF TECHNOLOGY

 

2.1         Technology Transfer.  Beginning on the Effective Date, Actelion will
use Commercially Reasonable Efforts to transfer to Kythera all items of Actelion
Licensed Know-How (including Manufacturing know-how specified in Exhibit 2.1,
but excluding the technology transfer required to transfer drug substance and
drug product Manufacturing Information to Kythera or its designated contract
manufacturing organization pursuant to Section 5.2 and as specified in
Exhibit 5.2) and Materials (“Actelion Technology”).  Notwithstanding the
foregoing Actelion will not be

 

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required to transfer any Compounds other than setipiprant.  The process,
timelines and content of the transfer will be described in Exhibit 2.1 to ensure
that the scope of the transfer, the format of the documents and the transfer
itself are clearly documented to ensure that the chain of custody is preserved
and documented.  Additionally, Actelion will provide a reasonable amount of
advice or support in connection with the foregoing transfer, as requested in
writing by Kythera. Kythera will reimburse Actelion for the time spent, at a
rate of $[***]/hour, and any out of pocket costs in relation to the transfer of
Actelion Technology as per Exhibits 2.1, 2.2(a)(i) and 5.2.  Kythera will use
the Actelion Technology for the purposes of exercising its rights, and
performing its obligations, under the Agreement.  On termination of this
Agreement, any Actelion Technology supplied by Actelion will be returned to
Actelion or destroyed as agreed upon in writing by the Parties.

 

2.2         Transfer of Actelion Regulatory Filings and Safety Information for
Compounds.

 

(a)          In accordance with the process and timelines described Exhibit 2.1,
Actelion will: (i) allow timely access, use and support of their existing
regulatory and technical documents related to Actelion’s setipiprant program for
Kythera’s submission of an IND for a Licensed Product, including the transfer of
copies of the then-current FDA regulatory filings on setipiprant to Kythera (in
eCTD format, or for the documents listed in Exhibit 2.2(a)(i), in the format
listed in such Exhibit) for incorporation into an IND to be produced by Kythera
and filed for a Licensed Product; and (ii) transfer to Kythera all
safety-related Information regarding setipiprant, including all adverse event
and significant adverse event reporting from pharmacovigilance databases
maintained by or on behalf of Actelion in its clinical development of
setipiprant, in a format that is agreed to by the Parties for incorporation into
a new Kythera pharmacovigilance database for a Licensed Product. Such access,
use and support would also include Actelion providing reasonable access to
Actelion staff to assist with the knowledge transfer to Kythera and the
preparation of Kythera’s initial IND for a Licensed Product, pursuant to
Section 2.2(b).  Actelion will provide, at a cost of $[***]/hour, a quality
check of the investigator brochure on Compound after Kythera has made the
update.  Kythera acknowledges that Actelion has made it aware that i) the [***]
of the setipiprant carcinogenicity studies is completed (ii)  the samples from
the aforementioned carcinogenicity studies are archived but not yet analyzed;
iii) the full evaluation of the study may cost [***] ([***]) CHF or more and may
take [***] ([***]) months or more and iv) will not be performed nor funded by
Actelion. Actelion will maintain, or cause the maintenance of, the archived
samples and instruct the CRO who performed the study to transfer it to Kythera,
and confirm to the CRO that, upon written request from Kythera, it can proceed
to the testing of the stored samples at Kythera’s expense.

 

(b)          During the [***] ([***]) month period after completion of the
transfer of the documents and Information required under Section 2.2(a), Kythera
may, via the Liaison, consult with applicable Actelion employees with experience
with Licensed Products, on a reasonable basis, to advise Kythera regarding
specific issues and assist Kythera in its use and understanding of all such
documents and Information.  All such consultations will occur at mutually
agreeable times and places.  Kythera will reimburse Actelion for the time spent
in connection therewith at a rate of $[***]/hour as well as for any reasonable
out-of-pocket costs or expenses (such as needed transportation and lodging
costs, if requested by Kythera) that Actelion incurs in connection with such
consultations and that are pre-approved by Kythera in writing.

 

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2.3         Liaisons.

 

(a)          Appointment.  Within thirty (30) days after the Effective Date,
each of the Parties will appoint a single individual to act as a single point of
contact between the Parties to assure a successful transfer of Actelion
Technology and to communicate with respect to matters under the Agreement (each,
a “Liaison”).  Each Party will notify the other Party promptly in writing of the
identity of, and contact information for, the notifying Party’s Liaison, and
each Party may change its designated Liaison from time to time upon written
notice to the other Party.  Any Liaison may designate a substitute to
temporarily perform the functions of that Liaison by written notice to the other
Party.

 

(b)          Responsibilities.  The Liaisons will: (i) coordinate the transfer
of Actelion Technology; (ii) be the point of first referral in all matters of
conflict resolution; (iii) identify and bring disputes to the attention of the
applicable Party in a timely manner; (iv) plan and coordinate cooperative
efforts and internal and external communications; and (v) otherwise take
responsibility for ensuring that relevant action items resulting from such Party
interactions are appropriately carried out or otherwise addressed.

 

2.4         Independence.  Subject to the terms of this Agreement, the
activities and resources of each Party will be managed by such Party, acting
independently and in its individual capacity.  The relationship between Actelion
and Kythera is that of independent contractors and neither Party will have the
power to bind or obligate the other Party in any manner.

 

3.                                    RESEARCH, DEVELOPMENT, MANUFACTURING AND
COMMERCIALIZATION OF PRODUCTS

 

3.1         Research, Development, and Manufacturing of Licensed Products

 

(a)          Scope & Diligence.  Kythera will have sole control and
responsibility for the Research, Development, Manufacture (except as described
in Section 5.1) and Commercialization of all Licensed Products.  As between the
Parties, Kythera will bear all costs and expenses associated with such
activities.  Kythera will use Commercially Reasonable Efforts to Develop and
Commercialize a Licensed Product in the Territory.  As part of such Commercially
Reasonable Efforts, Kythera will initiate (i.e., treat its first patient for) a
Proof of Concept Trial within [***] ([***]) months of the Effective Date.  If
Kythera is unable to initiate a Proof of Concept Trial within such initial [***]
([***])-month period, and the inability is due to factors not within Kythera’s
reasonable control (including a delay in obtaining required quantities of
Licensed Product, delays in obtaining approvals from an ethics committee or a
Regulatory Authority, or a force majeure), then upon receipt of Kythera’s
written request, Actelion will extend such initial [***] ([***])-month period
for initiation of the Proof of Concept Trial by an additional [***] ([***])
months.  If Kythera is unable to initiate a Proof of Concept Trial within such
initial [***] ([***])-month period, and the inability is due to factors within
Kythera’s reasonable control, then Kythera may seek a [***] ([***]) month
extension to initiate the Proof of Concept Trial by paying Actelion [***]
Dollars ($[***]) [***].  Such payment will be creditable against the milestone
owed under Section 7.2(a)(i). If Kythera is unable to initiate a Proof of
Concept Trial within such additional [***] ([***])-month or [***]-month period
(as applicable), then the Parties will meet to agree on whether a further
extension may be agreed upon or whether the agreement is terminated. In case the
Parties, acting in good faith, cannot agree on a

 

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further extension within one (1) month from the date of the first meeting, this
Agreement will be terminated with immediate effect.

 

(b)          Reports.  Beginning forty-five (45) days after the Effective Date,
and every six (6) months thereafter during the term of the Agreement, Kythera
will submit to Actelion a written progress report (substantially in the form of
Exhibit 3.1(b)) summarizing the Development and Commercialization performed by
or on behalf of Kythera on Licensed Products.  All such reports will be
considered Confidential Information of Kythera.

 

3.2         Standards of Conduct.  Kythera will perform, or will ensure that its
Affiliates, licensees, sublicensees and Third Party contractors perform, all
Research, Development, Manufacturing and Commercialization activities in a good
scientific and ethical business manner and in compliance with the terms of this
Agreement and all applicable laws, rules and regulations.

 

4.                                    REGULATORY

 

4.1         Kythera’s Role.  Kythera will have sole responsibility for (and bear
all costs and expenses associated with) all regulatory activities regarding
Licensed Products.  Kythera will also have sole responsibility for (and bear all
costs and expenses associated with) worldwide pharmacovigilance for such
Licensed Product.  Kythera will have the sole right and responsibility to
participate in all pricing and reimbursement approval proceedings relating to
each Licensed Product in the Territory.

 

4.2         Ownership of Regulatory Dossier.  Kythera will own all regulatory
filings for Licensed Products made after the Effective Date.  Kythera will
prepare and draft all filings (including any supplements or modifications
thereto and including the preparation of any electronic submission of a
Regulatory Approval Application) to Regulatory Authorities in each such country
in the Territory for such Licensed Product.

 

4.3         Recalls in the Territory.  Any decision to initiate a recall or
withdrawal of a Licensed Product in the Territory will be made by Kythera.  In
the event of any recall or withdrawal, Kythera will take any and all necessary
action to implement such recall or withdrawal in accordance with applicable law,
with assistance from Actelion as reasonably requested by Kythera to the extent
that Actelion manufactured or had manufactured concerned Licensed Product.  The
costs of any such recall or withdrawal in the Territory will be borne solely by
Kythera.

 

5.                                    ACTELION MANUFACTURING

 

5.1         Manufacture of Licensed Product.  Actelion will Manufacture, or
arrange with Third Parties for the Manufacture of Kythera’s requirements of the
Licensed Product as bulk packaged drug product, i.e., bulk tablets of [***] dose
and matching placebo(s), excluding finished packaging for the Proof of Concept
Trial.  As part of such Manufacture, Actelion and Kythera and/or Third Parties
agree to enter into a Quality Agreement, and Actelion will provide the
documentation to enable Kythera’s regulatory and quality function to test and
release all supplies of such Licensed Product for such Proof of Concept Trial
(if applicable).  The cost of such Manufacturing will be at a price equal to
[***] for such Licensed Product. [***] shall mean the [***] and [***] (including
[***]

 

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[***]) and indirect costs (including [***]) specifically [***] of the Licensed
Product.

 

5.2         Transfer of Manufacturing Information.  The transfer of the drug
product Manufacturing Information will be done during the manufacturing campaign
of Licensed Product for the Proof of Concept Trial, or any other such date as
the Parties agree. Actelion will introduce Kythera to and facilitate Kythera’s
interaction with Actelion’s manufacturers to enable the transfer to occur
directly between Actelion’s manufacturer and Kythera, given that most of the
know-how related to manufacturing is located at Actelion’s manufacturers. If not
done so sooner as per the previous sentence, within [***] ([***]) days after
Kythera’s receipt of final results from Kythera’s Proof of Concept Trial, or
sooner if so requested by Kythera or reflected in Exhibit 5.2, Kythera will
notify Actelion in writing if Kythera wants the Manufacturing Information
transferred to: (a) Kythera; or (b) a Third Party manufacturer reasonably
acceptable to Kythera.  As soon as is practicable after receiving Kythera’s
notice, Actelion will cause its third party manufacturer to transfer to Kythera
or such Third Party manufacturer, as the case may be, the Manufacturing
Information listed in Exhibit 5.2.  The reasonable costs and expenses incurred
by Actelion in carrying out such transfer and approved in advance by Kythera
will be reimbursed [***] percent ([***]%) by Kythera.

 

6.                                    LICENSES

 

6.1         Licenses to Kythera.

 

(a)          Subject to the terms and conditions of this Agreement, Actelion
hereby grants to Kythera an exclusive (even as to Actelion except to the extent
necessary to fulfill its obligations under this Agreement), sublicensable
(pursuant to Section 6.3), transferable (solely pursuant to Section 13.9),
royalty-bearing license under the Actelion Licensed Patents to Research,
Develop, make, have made, use, sell, offer for sale, import and otherwise
Commercialize Compounds and/or Licensed Products in the Field in the Territory.

 

(b)          Subject to the terms and conditions of this Agreement, Actelion
hereby grants to Kythera a non-exclusive, sublicensable (pursuant to
Section 6.3), transferable (solely pursuant to Section 13.9), royalty-free
license under the Actelion Licensed Know-How to Research, Develop, make, have
made, use, sell, offer for sale, import and otherwise Commercialize Compounds
and/or Licensed Products in the Field in the Territory. Kythera shall support
Actelion or other non-exclusive licensees regarding any request for information
or documentation from health authorities relating to such non-exclusive licenses
on the condition that Actelion and other non-exclusive licensees support Kythera
regarding any request for information or documentation from health authorities
relating to such non-exclusive licenses.

 

(c)          Subject to the terms and conditions of this Agreement, Actelion
hereby grants to Kythera a non-exclusive, sublicensable (pursuant to
Section 6.3), transferable (solely pursuant to Section 13.9), royalty-free
license under the Actelion Related Patents to Research, Develop, make, have
made, use, sell, offer for sale, import and otherwise Commercialize Compounds
and/or Licensed Products in the Field in the Territory.

 

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(d)          Subject to the terms and conditions of this Agreement, Actelion
hereby grants to Kythera a non-exclusive, sublicensable (pursuant to
Section 6.3), transferable (solely pursuant to Section 13.9), royalty-free
license under the Actelion FTO Patents to Research, Develop, make, have made,
use, sell, offer for sale, import and otherwise Commercialize Compounds and/or
Licensed Products in the Territory.  The “Actelion FTO Patents” mean any Patents
that: (i) are not Actelion Licensed Patents or Actelion Related Patents;
(ii) cover (A) manufacturing processes (including intermediates) or formulations
of Compounds or Licensed Products, or (B) uses of Compounds or Licensed Products
for hair growth or the prevention of hair loss; and (iii) Actelion or its
Affiliates Controls as of the Effective Date or during the Term.

 

6.2         No Additional Licenses.  Except as expressly provided in
Section 6.1, nothing in this Agreement grants either Party any right, title or
interest in and to the intellectual property rights of the other Party
(expressly, by implication or by estoppel).  For clarity, Actelion does not
grant Kythera the right to use in any Licensed Product any compound, which
compound or use thereof is covered by any intellectual property right (including
any kind of regulatory exclusivity) Controlled by Actelion, other than one or
more Compounds.

 

6.3         Sublicensing.  The licenses granted to Kythera in Section 6.1 will
be freely sublicensable by Kythera as follows: (a) Kythera has the right to
sublicense [***]; (b) Kythera has the right to sublicense [***]; and (c) Kythera
has the right to sublicense [***].  Kythera will remain responsible for each
permitted sublicensee’s compliance with the applicable terms and conditions of
this Agreement. Any agreement with a sublicensee must include provisions
substantially the same as those contained herein to ensure compliance with this
Agreement.

 

6.4         Retained Rights.  Actelion retains the right for itself and its
Affiliates to Manufacture, or arrange with Third Parties for the Manufacture of,
Licensed Products solely to the extent required under Section 5.1.

 

6.5         Actelion Exclusivity.  Actelion will not (and Actelion will ensure
that its Affiliates will not) Research, Develop, Manufacture (outside the scope
of this Agreement) or Commercialize the Compounds during the Term.

 

7.                                    COMPENSATION

 

7.1         License Fee.  Within [***] ([***]) days after the Effective Date,
Kythera will pay Actelion a license fee of One Million Five Hundred Thousand US
Dollars ($1,500,000).

 

7.2         Milestone Payments to Actelion.

 

(a)          Development and Regulatory Milestones.  Subject to Section 7.2(b),
Kythera will make the following, one-time milestone payments set forth below to
Actelion after the first achievement of each indicated event for a Licensed
Product by Kythera (or any of its Affiliates, licensees or sublicensees).

 

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Event

Milestone
Payment

(i) [***]

$[***]

(ii) [***]

$[***]

(iii) [***]

$[***]

(iv) [***]

$[***]

(v) [***]

$[***]

(vi) [***]

$[***]

(vii) [***]

$[***]

(viii) [***]

$[***]

(ix) [***]

$[***]

 

(b)          Milestone Payment Limitations.  The milestone events described in
Sections 7.2(a)(i) – (vi) will be paid once each, [***] for a Licensed Product. 
Milestone events described in Sections 7.2(a)(vii) – (ix) will be paid once
each, solely with respect to a Licensed Product [***], only after [***].  No
other milestone payments will be owed by Kythera (or its Affiliates, licensees
and sublicensees) with respect to a Licensed Product.

 

(c)          Milestone Payment Process.  Kythera will notify Actelion within
[***] ([***]) days after the achievement of each milestone event described in
Sections 7.2(a)(i) – (ix).  Actelion will invoice Kythera for the amount
associated with the applicable milestone event, and Kythera will pay Actelion
the applicable amount within [***] ([***]) days of receipt of the invoice.

 

7.3         Royalty Payments to Actelion for Net Sales of Licensed Products. 
Kythera will pay to Actelion royalties on Net Sales by Kythera (or its
Affiliates, licensees or sublicensees) of Licensed Products.   Royalties for Net
Sales of a given unit of a Licensed Product will be owed under either
Section 7.3(a) or under Section 7.3(b), and, if both an oral and a topical
formulation are being sold royalties will be owed under Section 7.3(a) for units
that are oral formulations and Section 7.3(b) for units that are topical
formulations.

 

(a)          For orally-dosed formulations of Licensed Products:

 

Portion of Net Sales of Licensed Products in the Territory in a calendar year

 

Royalty Rate

 

 

 

 

 

[***]%

 

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Portion of Net Sales of Licensed Products in the Territory in a calendar year

 

Royalty Rate

 

 

 

Less than or equal to $[***]

 

 

 

 

 

Greater than $[***] and less than or equal to $[***]

 

[***]%

 

 

 

Greater than $[***]

 

[***]%

 

(b)          For topical formulations of Licensed Products:

 

Portion of Net Sales of Licensed Products in the Territory in a calendar year

 

Royalty Rate

 

 

 

Less than or equal to $[***]

 

[***]%

 

 

 

Greater than $[***] and less than or equal to $[***]

 

[***]%

 

 

 

Greater than $[***]

 

[***]%

 

7.4         Third Party Royalties for Licensed Products in the Territory. 
Kythera may deduct from the royalties it would otherwise owe to Actelion
pursuant to Section 7.3 for a particular Licensed Product, [***] percent
([***]%) of all royalties payable to one or more Third Party(ies) in
consideration for rights [***] to Develop, Manufacture or Commercialize such
Licensed Product (where such rights are identified by Kythera after the
Effective Date), up to a maximum deduction of [***] percent ([***]%) of the
royalties otherwise due to Actelion for such Licensed Product pursuant to
Section 7.3.

 

7.5         Quarterly Payments and Reports.  All royalties due under Section 7.3
will be paid quarterly, on a country-by-country basis, within [***] ([***]) days
after the end of the relevant quarter for which royalties are due.  Kythera will
provide to Actelion within [***] ([***]) days after the end of each quarter a
report that summarizes the Net Sales of a Licensed Product during such quarter. 
Such reports will also include detailed information regarding the calculation of
royalties due pursuant to Section 7.3, including allowable deductions in the
calculation of Net Sales of Licensed Products on which royalties are paid.

 

7.6         Term of Royalties.  Actelion’s right to receive royalties under
Section 7.3 will begin on the First Commercial Sale of a Licensed Product in a
country and expire, on a country-by-country and Licensed Product-by-Licensed
Product basis, upon the later to occur of: (a) seven (7) years from First
Commercial Sale of such Licensed Product in such country, and (b) expiration in
such country of the last Valid Claim of such Licensed Product (the “Royalty
Term”); provided, however, that if such last Valid Claim expires prior to seven
(7) years after such First Commercial Sale, then, as of the date of the expiry
of such last Valid Claim, royalties on Net Sales of Licensed Products in such
country will be reduced by [***]% for the remainder of the Royalty Term. 
Notwithstanding the foregoing, the Royalty Term for Net Sales in a country in
the Territory will

 

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expire when reported sales revenues for a Generic Licensed Product over any
[***] ([***]) consecutive calendar quarters in such country have achieved [***]
percent ([***]%) or more of the average Net Sales of Licensed Products in such
country during the [***] ([***]) consecutive calendar quarters [***] in which
such Generic Licensed Product is first sold commercially in such country.

 

7.7         Payment Method.  All payments due under this Agreement to Actelion
will be made by bank wire transfer in immediately available funds to an account
designated by Actelion.  All payments hereunder will be made in Dollars.

 

7.8         Taxes.  Except for taxes on Actelion’s income, Kythera shall be
liable for and pay all taxes imposed in connection with any and all payments
under this Agreement.

 

7.9         Sublicenses.  In the event Kythera grants any permitted licenses or
sublicenses to Third Parties to sell Licensed Products that are subject to
royalty payments under Section 7.3, Kythera will have the responsibility to
account for and report sales of any Licensed Product by a licensee or a
sublicensee on the same basis as if such sales were Net Sales by Kythera. 
Kythera will pay to Actelion: (a) royalties on such sales as if such sales of
the licensee or sublicensee were Net Sales of Kythera or any of its Affiliates;
and (b) milestones payments pursuant to Section 7.2 based on the achievement by
such licensee or sublicensee of any milestone event contemplated in such
Section 7.2 as if such milestone event had been achieved by Kythera or any of
its Affiliates hereunder.  Any sales by Kythera’s Affiliates and sublicensees of
Kythera or such sublicensee’s Affiliates, in each case to Third Parties, will be
aggregated with sales by Kythera for the purpose of calculating the aggregate
Net Sales in Section 7.3.

 

7.10      Foreign Exchange.  Conversion of sales recorded in local currencies to
Dollars will be performed in a manner consistent with Kythera’s normal practices
used to prepare its audited financial statements for internal and external
reporting purposes, which uses a widely accepted source of published exchange
rates, and such methodology will be included in the Net Sales Report provided to
Actelion.

 

7.11      Records.  Kythera will keep (and will ensure that its Affiliates,
licensees and sublicensees will keep) such records as are required to determine,
in a manner consistent with GAAP and this Agreement, the sums or credits due
under this Agreement.  All such books, records and accounts will be retained by
Kythera until the later of: (a) three (3) years after the end of the period to
which such books, records and accounts pertain; and (b) the expiration of the
applicable tax statute of limitations (or any extensions thereof), or for such
longer period as may be required by applicable law, rule or regulation.  Kythera
will require its licensees and sublicensees to provide to Kythera a report
detailing the Net Sales calculations made by such licensee or sublicensee, which
report will be made available to Actelion in connection with any audit conducted
by Actelion pursuant to Section 7.12.

 

7.12      Audits.  Actelion will have the right to have an independent certified
public accountant, reasonably acceptable to Kythera, to have access during
normal business hours, and upon reasonable prior written notice, to examine only
those records of Kythera (and its Affiliates, licensees and sublicensees) as may
be reasonably necessary to determine, with respect to any calendar year ending
not more than three (3) years prior to Actelion’s request, the correctness or
completeness of any report or payment made under this Agreement.  The foregoing
right of review

 

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may be exercised only once per year and only once with respect to each such
periodic report and payment.  Results of any such examination will be:
(a) limited to information relating to the Licensed Products; (b) made available
to both Parties; and (c) subject to Article 9.  Actelion will bear the full cost
of the performance of any such audit, unless such audit discloses a variance to
the detriment of Actelion of more than five percent (5%) from the amount of the
original report, royalty or payment calculation, in which case Kythera will bear
the full cost of the performance of such audit.  The results of such audit will
be final, absent manifest error.

 

7.13      Interest.  Any undisputed payments or portions thereof due hereunder
that are not paid on the date such payments are due under this Agreement will
bear interest at a rate equal to the lesser of: (a) [***] ([***]) percentage
points above the Prime Rate as published by Citibank, N.A., New York, New York,
or any successor thereto, at 12:01 a.m. on the first day of each quarter in
which such payments are overdue; or (b) the maximum rate permitted by law, in
each case calculated on the number of days such payment is delinquent,
compounded monthly.

 

7.14      Payments to or Reports by Affiliates.  Any payment required under any
provision of this Agreement to be made to either Party or any report required to
be made by any Party will be made to or by an Affiliate of that Party if
designated in writing by that Party as the appropriate recipient or reporting
entity.

 

8.                                    PATENT PROSECUTION AND ENFORCEMENT

 

8.1         Ownership.

 

(a)          The inventorship of all Sole Inventions and Joint Inventions will
be determined in accordance with the U.S. patent law.

 

(b)          Actelion will own the entire right, title and interest in and to
any and all of its Actelion Related Patents and of its Sole Inventions, and
Patents claiming such Sole Inventions (“Actelion Sole Invention Patents”). 
Kythera will own the entire right, title and interest in and to any and all of
its Sole Inventions, and Patents claiming only such Sole Inventions (and no
Joint Inventions) (“Kythera Sole Invention Patents”).  Kythera and Actelion will
be joint owners in and to any and all Joint Inventions and Patents claiming such
Joint Inventions (“Joint Invention Patents”).  Kythera and Actelion as joint
owners will each have the right to exploit, to grant licenses under, to assign
and to otherwise dispose of such Joint Inventions, without an accounting or
obligation to, or consent required from, the other Party, but subject to the
licenses hereunder and the other terms and conditions of this Agreement.  Each
Party grants to the other Party a nonexclusive, fully-paid, royalty-free,
irrevocable, perpetual and sublicensable license under the Joint Invention
Patents to make, use, sell, offer for sale and import inventions claimed in the
Joint Invention Patents

 

(c)          All employees, agents and contractors of each Party will be under
written obligation to assign any inventions and related intellectual property to
the Party for whom they are employed or are providing services.

 

(d)          Solely for the purposes of this Section 8, the Parties acknowledge
and agree that this Agreement will be deemed to be a “Joint Research Agreement”
as defined under 35 U.S.C. 103(c).

 

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8.2         Disclosure.  Each Party will submit a written report to the other
Party, no less frequently than within [***] ([***]) days after the end of each
quarter, describing any Joint Invention arising during the prior quarter in the
course of the Agreement which it believes may be patentable or at such earlier
time as may be necessary to preserve patentability of such invention. For the
avoidance of doubt, if a Party believes that there was no patentable Joint
Invention during the prior quarter, no report will be submitted.  Actelion will
provide (at its expense) to Kythera such assistance and execute such documents
as are reasonably necessary to permit the filing and prosecution of such patent
application to be filed on such Joint Invention, or the issuance, maintenance,
extension or assignment of any resulting Patent.

 

8.3         Patent Prosecution and Maintenance; Abandonment.

 

(a)          Prosecution and Maintenance.

 

(i)           Filing, Prosecution and Maintenance by Kythera.  Within [***]
([***]) days after the Effective Date, Actelion will provide Kythera all files
related to the preparation, filing, prosecution and maintenance (including any
interferences, reissues, reexaminations and oppositions) of the Actelion
Licensed Patents.  Kythera will be responsible for the preparation, filing,
prosecution and maintenance (including any interferences, reissues,
reexaminations and oppositions) of all Actelion Licensed Patents that are
exclusively licensed to Kythera under Section 6.1 and the Joint Invention
Patents (collectively, the “Kythera Prosecuted Patents”), provided that such
responsibilities may be carried out by external patent counsel or vendor
selected by Kythera, or by Kythera internal patent counsel in conjunction with
external patent counsel or vendor selected by Kythera (and, regarding payment of
annuities and maintenance fees, Kythera may seek to maintain the current vendor
relationship with the existing annuity service provider for the Actelion
Licensed Patents); and, provided further, that: (1) Kythera will begin
prosecuting the Actelion Licensed Patents (as indicated on Exhibit 1.2) within
[***] ([***])] days of receiving the last of the files for the Actelion Licensed
Patents; and (2) Kythera will begin maintenance of the Actelion Licensed Patents
(as indicated on Exhibit 1.2) within [***] ([***]) days of receiving the last of
the files for the Actelion Licensed Patents.  Kythera, or its external counsel
or vendor, will provide Actelion with a written update of the filing,
prosecution and maintenance status (including payments of annuities and
maintenance fees) for each of the Kythera Prosecuted Patents on a quarterly
basis, and Kythera (or its external counsel) will provide Actelion with drafts
of proposed filings and prosecution documents to permit Actelion a reasonable
opportunity for review and comment before such filings or documents are due. 
Actelion will provide any comments at least [***] ([***]) days prior to the
original response deadlines that are required for such filing (without regard to
applicable extensions).  In the absence of a response from Actelion, Kythera may
submit such proposed filings or prosecution documents in keeping with the terms
of this Agreement.

 

(ii)          Patent Term Extension, Abandonment or Inadequate Maintenance by
Kythera.

 

(1)          Patent Term Extension. If available, patent term extension (e.g.,
an extension in the United States under 35 USC 156 or equivalent extension in
other countries) shall be requested and filed on Actelion Licensed Patents in
any country in accordance with the respective regulations and requirements of
that country.

 

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(2)          Abandonment.  If Kythera decides not to continue the prosecution or
maintenance of a patent application or patent within the Kythera Prosecuted
Patents in any country, Kythera will provide Actelion with notice of this
decision at least [***] ([***]) days prior to any pending lapse or abandonment
thereof (without regard to applicable extensions), and Actelion will thereafter
have the right to assume responsibility for the filing, prosecution and
maintenance of such patent or patent application by so notifying Kythera in
writing.  If Actelion assumes such responsibility for such filing, prosecution
and maintenance, then: (A) Kythera will cooperate as reasonably requested by
Actelion to facilitate control of such filing, prosecution and maintenance by
Actelion (especially, Kythera will immediately provide the respective files
related to the preparation, filing, prosecution and maintenance (including any
interferences, reissues, reexaminations and oppositions) of the patent
application or patent); and (B) such patent application or patent will no longer
be an Actelion Licensed Patent subject to the license in Section 6.1(a) and all
rights will revert to Actelion.

 

(3)          [***] by Kythera.  If Kythera [***] within the Kythera Prosecuted
Patents in a given country, and such patent is [***] in that country solely
because of [***], then the royalty obligation under Section 7.3 associated with
Licensed Products covered by such abandoned/not-extended patent in such country
will continue in such country until the [***], had the patent [***].

 

(4)          [***].  Should Kythera [***] in a particular country, then for that
country, the royalty obligation under Section 7.3 associated with Licensed
Products in such country will [***], or not [***]. In the event that Kythera
[***] and such [***], the [***] will [***] this Section 8.3(a)(ii)(4).

 

(5)          Royalty Term in case of Section 8.3 (a)(ii)(3) or Section 8.3
(a)(ii)(4).  For purposes of Section 7.6, a Valid Claim is [***], and any
available extension thereof (as described in Section 8.3(a)(ii)(1)), had the
[***]. The royalty reduction of [***]%  within the [***] and the expiry of the
Royalty Term [***] will only apply after the [***], and any [***], had the
[***].

 

(iii)         Kythera Sole Invention Patents.  Kythera will be responsible for
the filing, prosecution (including any interferences, reissues, reexaminations
and oppositions) and maintenance of all Sole Invention Patents Controlled by
Kythera.

 

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(iv)         Copies of Files.  Kythera will provide copies of files of any
Actelion Licensed Patent if requested by Actelion with good cause (e.g. in case
needed for requesting patent term extensions and the like).

 

(b)          Payment of Prosecution Costs.  Kythera will pay the expenses
associated with the filing, prosecution (including any interferences, reissue
proceedings, reexaminations and oppositions) and maintenance of: (i) its Sole
Inventions Patents; and (ii) any Kythera Prosecuted Patents prosecuted by
Kythera under Section 8.3(a)(i).   Actelion will pay the expenses associated
with the filing, prosecution (including any interferences, reissue proceedings,
reexaminations and oppositions) and maintenance of any Actelion Related Patents
and any Actelion FTO Patents.

 

8.4         Enforcement of Patent Rights.  If either Party becomes aware of a
suspected infringement of any Actelion Licensed Patents or Joint Invention
Patents through the development, manufacture or sale of a Licensed Product by a
Third Party, such Party will notify the other Party promptly, and following such
notification, the Parties will confer.  Kythera will have the first right, but
will not be obligated, to bring an infringement action against such Third Party
at its own expense and by counsel of its own choice, and Actelion will have the
right to participate in such action, at its own expense and by counsel of its
own choice.  If Kythera fails to bring such an action or proceeding prior to the
earlier of: (a) [***] ([***]) days following Kythera’s receipt of notice of
alleged infringement; or (b) [***] ([***]) days before the time limit, if any,
set forth in the appropriate laws and regulations for the filing of such
actions, Actelion will have the right to bring and control any such action, at
its own expense and by counsel of its own choice, and Kythera will have the
right to be represented in any such action, at its own expense and by counsel of
its own choice.  If a Party brings an infringement action pursuant to this
Section 8.4, the other Party will reasonably assist the enforcing Party (at the
enforcing Party’s expense) in such actions or proceedings if so requested, and
will lend its name to such actions or proceedings if required by law in order
for the enforcing Party to bring such action.  Neither Party will have the right
to settle any patent infringement litigation under this Section 8.4 in a manner
that diminishes the rights or interests of the other Party without the prior
written consent of such other Party, such consent not to be unreasonably
withheld or delayed.  In case Kythera brings such an action or proceeding, any
recovery realized as a result of such litigation, after [***], will be [***]. In
case Actelion brings such an action or proceeding, any recovery realized as a
result of such litigation will be [***].

 

8.5         Data Exclusivity and Orange Book Listings.  With respect to data
exclusivity periods (such as those periods listed in the FDA’s Orange Book
(including any available pediatric extensions) or periods under national
implementations of Directive 2001/EC/83, and all international equivalents),
Kythera will use Commercially Reasonable Efforts consistent with its obligations
under applicable law (including any applicable consent order) to seek, maintain
and enforce all such data exclusivity periods available for the Licensed
Products.  With respect to filings in the FDA Orange Book (and foreign
equivalents) for issued patents for a Licensed Product, upon request by Kythera
(and at Kythera’s expense), Actelion will provide reasonable cooperation to
Kythera in filing and maintaining such Orange Book (and foreign equivalent)
listings.

 

8.6         Patent Term Extension.  Actelion will cooperate with any of
Kythera’s efforts to obtain patent term extension (including any pediatric
exclusivity extensions as may be available) or

 

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supplemental protection certificates or their equivalents in any country with
respect to patent rights covering the Licensed Products.

 

8.7         Notification of Patent Certification.  Actelion will notify and
provide Kythera with copies of any allegations of alleged patent invalidity,
unenforceability or non-infringement of an Actelion Licensed Patent hereunder,
including allegations pursuant to a Paragraph IV Patent Certification by a third
party filing an Abbreviated New Drug Application, an application under
§505(b)(2) of the Federal Food, Drug, and Cosmetic Act or other similar patent
certification by a third party, and any foreign equivalent thereof.  Such
notification and copies will be sent to Kythera by Actelion as soon as
practicable and at least within [***] ([***]) days after Actelion receives such
certification.

 

8.8         Defense of Third Party Claims.  If a claim is brought by a Third
Party that any Compound under the Agreement infringes the intellectual property
rights of such Third Party, each Party will give prompt written notice to the
other Party of such claim, and following such notification, the Parties will
confer on how to respond.

 

8.9         Kythera may not limit the scope of protection of any Actelion
Licensed Patent, for instance in prosecution, opposition, litigation and the
like, without prior written consent of Actelion, such consent not to be
unreasonably withheld or delayed.

 

9.                                    CONFIDENTIALITY

 

9.1         Nondisclosure of Confidential Information.  Subject to Section 9.2,
all Information and Materials disclosed by one Party to the other Party pursuant
to this Agreement, and, subject to Section 9.7, Information that is generated
pursuant to this Agreement with respect to Compounds or Licensed Products (for
so long as such Compound or Licensed Product is not removed from the Agreement
as a result of a Licensed Product specific termination pursuant to
Section 10.2), will be “Confidential Information” for all purposes hereunder. 
The terms of this Agreement will be considered Confidential Information of both
Parties.  The Parties agree that during the period from the Effective Date
through the Term, and for a period of [***] ([***]) years thereafter, a Party
receiving Confidential Information of the other Party will: (a) use Commercially
Reasonable Efforts to maintain in confidence such Confidential Information (but
not less than those efforts as such Party uses to maintain in confidence its own
proprietary industrial information of similar kind and value) and not to
disclose such Confidential Information to any Third Party without prior written
consent of the other Party (such consent not to be unreasonably withheld,
delayed or conditioned), except for disclosures made in confidence to any Third
Party under terms consistent with this Agreement; and (b) not use such other
Party’s Confidential Information for any purpose except those permitted by this
Agreement (it being understood that this Section 9.1 will not create or imply
any rights or licenses not expressly granted under Article 6, and it is also
understood that, upon termination of this Agreement, a Party’s right to use the
Confidential Information of the other Party will cease).

 

9.2         Exceptions.  The obligations in Section 9.1 will not apply with
respect to any portion of the Confidential Information that the receiving Party
can show by competent written proof:

 

(a)          is publicly disclosed by the disclosing Party, either before or
after it is disclosed to the receiving Party hereunder;

 

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(b)          was known to the receiving Party or any of its Affiliates, without
obligation to keep it confidential, prior to disclosure by the disclosing Party;

 

(c)          is subsequently disclosed to the receiving Party or any of its
Affiliates by a Third Party lawfully in possession thereof and without
obligation to keep it confidential;

 

(d)          is published by a Third Party or otherwise becomes publicly
available or enters the public domain, either before or after it is disclosed to
the receiving Party, and is not directly or indirectly supplied by the receiving
Party in violation of this Agreement; or

 

(e)          has been independently developed by employees or contractors of the
receiving Party or any of its Affiliates without the aid, application or use of
the disclosing Party’s Confidential Information.

 

9.3         Authorized Disclosure.  A Party may disclose the Confidential
Information disclosed by the other Party to the extent such disclosure is
reasonably necessary in the following instances; provided that notice of any
such disclosure will be sent as soon as practicable to the other Party:

 

(a)          during the Term, when filing or prosecuting Patents covering Sole
Inventions, Joint Inventions or Licensed Products, in each case pursuant to
activities under this Agreement;

 

(b)          during the Term, when making regulatory filings;

 

(c)          when prosecuting or defending litigation;

 

(d)          when complying with applicable governmental laws and regulations or
complying with the requirements of the national securities exchanges or other
stock markets on which such Party’s securities are traded; and

 

(e)          when disclosing to a receiving Party’s: Affiliates; potential or
actual collaborators, partners, and licensees (including potential co-marketing
and co-promotion contractors); potential or actual investment bankers,
acquirers, lenders or investors; employees; consultants; and agents, each of
whom, prior to disclosure, must be bound by similar obligations of
confidentiality and non-use as set forth in this Article 9; provided that a
confidentiality and non-use period of [***] ([***]) years will be sufficient.

 

9.4         Termination of Prior Agreements.  As of the Effective Date, this
Agreement terminates the confidential disclosure agreement that is between
Actelion and Kythera and that is effective as of December 13, 2013 (such
confidential disclosure agreement, as amended, the “Prior CDA”).  All
Information exchanged between the Parties with respect to Licensed Products
under the Prior CDA will be deemed Confidential Information and will be subject
to the terms of this Article 9.

 

9.5         Publicity.  The Parties agree that the public announcement by
Kythera of the execution of this Agreement will be substantially in the form of
the press release attached as Exhibit 9.5.  Any other publication, news release
or other public announcement relating to the execution of this Agreement will
first be reviewed and approved by both Parties; provided,

 

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however, that any securities filing that is required by law, rule or regulation,
including disclosures required by the U.S. Securities and Exchange Commission,
or made pursuant to the requirements of the national securities exchange or
other stock market on which such Party’s securities are traded, as advised by
the disclosing Party’s counsel, will be made pursuant to Section 9.6.

 

9.6         Securities Filings.  If a Party is required by applicable law,
rule or regulation to make a securities filing relating to the execution of this
Agreement with the appropriate governmental authorities (including the U.S.
Securities and Exchange Commission, and any securities exchange on which
securities of such Party are listed), then the Party under such requirement will
prepare a draft of such securities filing for review and comment by the other
Party.  If such securities filing includes the disclosure of this Agreement and
its terms, the Party under such disclosure obligation will include a
confidential treatment request and a proposed redacted version of this Agreement
as part of such draft.  Such draft securities filing will be provided to the
other Party reasonably in advance of the deadline for such securities filing,
and the other Party agrees to promptly (and in any event, no less than [***]
([***]) days (or such shorter time to meet any filing deadline where it was not
practical to provide the other Party with [***] ([***])-days’ notice) after
receipt of such confidential treatment request and proposed redactions) give its
input in a reasonable manner in order to allow the Party seeking disclosure to
file its request within the timelines proscribed by the regulations of
applicable governmental authorities or securities exchange.  The Party seeking
such disclosure will exercise Commercially Reasonable Efforts to obtain
confidential treatment of this Agreement from the applicable governmental
authority or securities exchange as represented by the redacted version reviewed
by the other Party.

 

9.7         Publications.  Subject to Section 9.3 and Section 9.6 (for
securities filings), each Party agrees to provide the other Party the
opportunity to review any proposed disclosure that contains Confidential
Information of the other Party and that would or may constitute an oral, written
or electronic public disclosure if made (including the full content of proposed
abstracts, manuscripts or presentations relating to Compound), or which
otherwise may contain Confidential Information, at least [***] ([***]) days
prior to its intended submission for publication and agrees, upon request, not
to submit any such abstract or manuscript for publication until the other Party
is given a reasonable period of time to secure patent protection for any
material in such publication which it believes to be patentable, such reasonable
period not to exceed [***] ([***]) months.  Both Parties understand that a
reasonable commercial strategy may require delay of publication of information
or filing of patent applications.  The Parties agree to review and consider
delay of publication and filing of patent applications under certain
circumstances.  The Liaisons (or the Parties), as appropriate, will review such
requests and recommend subsequent action.  Subject to Section 9.3 and
Section 9.6 (for securities filings), neither Party will have the right to
publish or present Confidential Information of the other Party which is subject
to Section 9.1.  Nothing contained in this Section 9.7 will prohibit the
inclusion of Confidential Information of the non-filing Party necessary for a
patent application, provided the non-filing Party is given a reasonable
opportunity to review the extent and necessity for its Confidential Information
to be included prior to submission of such patent application related to the
Agreement.  Any disputes between the Parties regarding delaying a publication or
presentation to permit the filing of a patent application will be referred to
the Liaisons (or the Parties), as appropriate.

 

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10.                            TERM AND TERMINATION

 

10.1      Term.  This Agreement will become effective on the Effective Date and
will remain in effect until the expiration of all payment obligations under
Article 7, unless earlier terminated in accordance with Section 10.2 or by
mutual written agreement of the Parties (the “Term”).  Upon the expiration of
the Term with respect to a Licensed Product in a country, Kythera will have a
fully-paid, perpetual license under Section 6.1 for the making, using, selling,
offering for sale and importing of such Licensed Product in such country.

 

10.2      Termination Provisions.

 

(a)          Termination for Uncured Material Breach.  Subject only to
Section 12.5, if either Party believes that the other is in material breach of
this Agreement (including any material breach of a representation or warranty
made in this Agreement), then the non-breaching Party may deliver notice of such
breach to the other Party.  In such notice the non-breaching Party will identify
the actions or conduct that such Party would consider as an acceptable cure of
such breach.  The allegedly breaching Party will have thirty (30) days to cure
such breach; provided, however, if the allegedly breaching Party disputes in
good faith the existence of a material breach, the thirty (30) day cure period
will be tolled until such time as the dispute is resolved by the Parties
pursuant to Section 13.1(a).  If the Party receiving notice of breach fails to
cure such breach within the 30-day period (as may be tolled by the foregoing
sentence), then the Party originally delivering the notice may terminate this
Agreement by providing at least thirty (30) days advance written notice to the
allegedly breaching Party.

 

(b)          Termination in case of insolvency.  If either Party (the “Insolvent
Party”): (i) becomes insolvent, or institutes or has instituted against it a
petition for bankruptcy or is adjudicated bankrupt; or (ii) executes a bill of
sale, deed of trust, or a general assignment for the benefit of creditors; or
(iii) is dissolved or subject to Section 13.9, transfers a substantial portion
of its assets to a Third Party; or (iv) a receiver is appointed for the benefit
of its creditors, or a receiver is appointed on account of insolvency; then the
Insolvent Party will immediately notify the other Party in writing of such
event, and such other Party will be entitled to terminate this Agreement
immediately upon written notice to the Insolvent Party.

 

(c)          Termination by Kythera At-will.  Kythera will have the right to
terminate this Agreement at-will, in whole or on a Licensed Product-by-Licensed
Product basis, upon providing at least ninety (90) days prior written notice to
Actelion, at the end of which the termination will be effective. 
Notwithstanding the foregoing, Kythera may not terminate at-will during an
on-going clinical trial of a Licensed Product, except for reasons of patient
safety.

 

10.3      Survival; Effect of Termination.

 

(a)          In the event of termination of this Agreement, the following
provisions of this Agreement will survive: Articles 1 (Definitions) and 12
(Indemnification); and Sections 7.11 (Records), 8.1 (Ownership of IP), 8.3
(solely with respect to Joint Invention Patents), 8.4 (solely with respect to
Joint Invention Patents), 9.1, 9.2, 9.3, 9.4, 10.3, 10.4, 10.5 (but only in case
of termination by Kythera under 10.2 (b)), 13.1, 13.2, 13.3, 13.7, 13.8, 13.10
and 13.13.

 

(b)          In any event, termination of this Agreement will not: (i) relieve
the Parties of any liability which accrued hereunder prior to the effective date
of such termination; (ii) preclude

 

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either Party from pursuing all rights and remedies it may have hereunder or at
law or in equity with respect to any breach of this Agreement; or
(iii) prejudice either Party’s right to obtain performance of any obligation.

 

10.4      Licenses and Rights on Termination.

 

(a)          Termination under Section 3.1. or Section 10.2(a) or
Section 10.2(b) by Actelion or under Section 10.2(c) by Kythera.  If Actelion
terminates this Agreement pursuant to Section 3.1, Section 10.2(a) or
Section 10.2(b), or if Kythera terminates this Agreement pursuant to
Section 10.2(c), then the license granted to Kythera under Section 6.1 will
automatically terminate and revert to Actelion.  All [***] Compound and/or
Licensed Product [***] in a [***]. Kythera shall provide Actelion with a report
regarding the status, including, but not limited to possible outstanding issues,
of any filings with Regulatory Authorities. Furthermore, the Parties shall
notify relevant Regulatory Authorities of the transfer as required by local
rules or regulations.

 

(b)          Kythera’s Alternative Right to Termination.  If Kythera has the
right to terminate this Agreement pursuant to Section 10.2(a) because Actelion
is the breaching Party, then Kythera will have the right, in lieu of its right
to terminate the entire Agreement, to have all licenses granted by Actelion
under this Agreement survive, subject to Kythera’s fulfillment of fifty percent
(50%) of its payment obligations under Article 7 after what would be the
effective date of such termination.

 

10.5      Assignment of Actelion Licensed Patents.  Actelion hereby irrevocably
assigns to Kythera the Actelion Licensed Patents; provided, however, that such
assignment will be under the suspensive condition of a termination of this
Agreement by Kythera pursuant to Section 10.2(b).  Kythera hereby accepts such
assignment.  In consideration for such assignment, Kythera will pay to Actelion
an amount equal to [***], where the Parties agree that such [***] will be equal
to the [***].  Furthermore, the Parties agree that such [***] will be paid by
Kythera to Actelion [***].  Once Kythera has paid Actelion [***], Kythera will
automatically owe no further amounts to Actelion for the assignment of the
Actelion Licensed Patents.

 

11.                            REPRESENTATIONS AND WARRANTIES AND COVENANTS

 

11.1      Mutual Authority.  Actelion and Kythera each represents and warrants
to the other Party as of the Effective Date that: (a) it has the authority and
right to enter into and perform this Agreement; (b) this Agreement is a legal
and valid obligation binding upon it and is enforceable in accordance with its
terms, subject to applicable limitations on such enforcement based on bankruptcy
laws and other debtors’ rights; and (c) the execution, delivery and performance
of this Agreement will not conflict in any material fashion with the terms of
any other agreement or instrument to which it is or becomes a party or by which
it is or becomes bound, nor violate any law

 

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or regulation of any court, governmental body or administrative or other agency
having authority over it.

 

11.2      Actelion Representations and Warranties.  Actelion represents and
warrants to Kythera that, as of the Effective Date:

 

(a)          Actelion owns the Actelion Licensed Patents and has made all
filings and payments, and taken all other actions required to be made or taken,
to maintain the Actelion Licensed Patents so that the Actelion Licensed Patents
are not abandoned;

 

(b)          To the best of Actelion’s knowledge, the composition of matter or
method of manufacture of the Compounds do not infringe any Patents owned by a
Third Party or misappropriate any Third Party’s trade secrets;

 

(c)          Actelion and its Affiliates do not own, or have a license to, any
Patents directed to or claiming any Compounds, other than the Actelion Licensed
Patents;

 

(d)          no Compound is subject either to a license with a Third Party, or
an option for a license, pursuant to an agreement between Actelion and any Third
Party (other than material transfer agreements between Actelion and academic
institutions);

 

(e)          there are no rights that Actelion or its Affiliates currently own,
or to which Actelion or its Affiliates currently has a license, that are within
the Actelion Licensed Patents or Actelion Licensed Know-How (or that would be
but for the terms of any agreement pursuant to which it has given up Control
thereof, or pursuant to which it has rights to such Patents or Information but
lacks Control thereof), to which it cannot grant a license of the scope in this
Agreement;

 

(f)           Actelion has unencumbered rights to grant licenses of the scope in
this Agreement under Patents that are either owned by Actelion or its Affiliates
or are the subject of a license from a Third Party to Actelion that includes the
right to sublicense, in each case to the extent such Patents claim any Compound;

 

(g)          the scientific Information relating to setipiprant that Actelion or
its Affiliates delivered or made available to Kythera (whether directly or
through its Third Party advisors) prior to the Effective Date (including any
Information regarding the safety, efficacy, toxicology, potential side effects,
pharmacokinetics, and pharmacodynamics of setipiprant) is representative of the
complete set of scientific Information in the Control of Actelion and its
Affiliates as of the Effective Date that relates to setipiprant, and Actelion
and its Affiliates have not withheld from Kythera any unfavorable data or
results of any pre-clinical or clinical studies of setipiprant, including
unfavorable data and results of any pharmacokinetic, absorption, distribution,
metabolism or excretion studies undertaken with respect to setipiprant;

 

(h)          Actelion’s IND for setipiprant is accurate, true and complete up to
the date of inactivation, which is [***], except for any data provided by
Actelion to Kythera pursuant to Section 2.2(a)(iii);

 

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(i)           except for the [***] tablet form of setipiprant, the Chemistry,
Manufacturing and Controls (“CMC”) portion of Actelion’s IND for setipiprant is
accurate, true and complete up to the date of inactivation, which is [***];

 

(j)           the scientific Information given to Kythera purporting to be
associated with the Compounds actually is so associated, and any physical
samples given to Kythera under this Agreement are Compounds; and

 

(k)          To the best of Actelion’s knowledge, Actelion and its Affiliates
Control, with respect to the license set forth in Section 6.1 for the Compounds
and Licensed Products containing or comprising such Compounds, all reasonably
relevant intellectual property relating to Compounds that was generated by any
Third Party in the course of such Third Party’s testing or other use of the
Compounds pursuant to an agreement between Actelion (or its Affiliate) and such
Third Party entered into prior to the Effective Date (other than material
transfer agreements between Actelion and academic institutions).

 

11.3      Performance by Affiliates.  The Parties recognize that each Party may
perform some or all of its obligations under this Agreement through Affiliates;
provided, however, that each Party will remain responsible and guarantee
performance by its Affiliates and will cause its Affiliates to comply with the
provisions of this Agreement in connection with such performance.  In
particular, if any Affiliate of a Party participates under this Agreement with
respect to Compounds: (a) the restrictions of this Agreement which apply to the
activities of a Party with respect to Compounds will apply equally to the
activities of such Affiliate; and (b) the Party affiliated with such Affiliate
will assure, and hereby guarantees, that any intellectual property developed by
such Affiliate will be governed by the provisions of this Agreement (and subject
to the licenses set forth in Article 6) as if such intellectual property had
been developed by the Party.

 

12.                            INDEMNIFICATION AND LIMITATION OF LIABILITY

 

12.1      Mutual Indemnification.  Subject to Section 12.3, each Party hereby
agrees to indemnify, defend and hold harmless the other Party, its Affiliates,
and their respective directors, employees and agents from and against any and
all Third Party suits, claims, actions, demands, liabilities, expenses and/or
losses, including reasonable legal expenses and reasonable attorneys’ fees
(“Loss(es)”) to the extent such Losses result from any: (a) breach of any
representation or warranty contained in the Agreement by the indemnifying Party;
(b) breach of the Agreement or applicable law by such indemnifying Party; or
(c) negligence or willful misconduct of the indemnifying Party, its Affiliates
or (sub)licensees, or their respective directors, employees and agents in the
performance of the Agreement.

 

12.2      Indemnification by Kythera.  Subject to Section 12.3, Kythera hereby
agrees to indemnify, defend and hold harmless Actelion and its directors,
employees and agents from and against any and all Losses to the extent such
Losses result from the manufacture, use, handling, storage, sale or other
disposition of Licensed Products by Kythera or its Affiliates, agents or
sublicensees, except to the extent such Losses result from any negligence, gross
negligence or willful misconduct by Actelion, its Affiliates or (sub)licensees,
or their respective directors, employees and agents in the performance of the
Agreement.

 

12.3      Conditions to Indemnification.  As used herein, “Indemnitee” will mean
a Party entitled to indemnification under the terms of Sections 12.1 or 12.2.  A
condition precedent to each

 

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Indemnitee’s right to seek indemnification under such Sections 12.1 or 12.2 is
that such Indemnitee will:

 

(a)          inform the indemnifying Party under such applicable Section 12.1 or
Section 12.2 of a Loss as soon as reasonably practicable after it receives
notice of the Loss;

 

(b)          permit the indemnifying Party to assume direction and control of
the defense, litigation, settlement, appeal or other disposition of the Loss
(including the right to settle the claim solely for monetary consideration);
provided, that the indemnifying Party will seek the prior written consent (such
consent not to be unreasonably withheld, delayed or conditioned) of any such
Indemnitee as to any settlement which would materially diminish or materially
adversely affect the scope, exclusivity or duration of any Patents licensed
under this Agreement, would require any payment by such Indemnitee, would
require an admission of legal wrongdoing in any way on the part of an
Indemnitee, or would effect an amendment of this Agreement; and

 

(c)          fully cooperate (including providing access to and copies of
pertinent records and making available for testimony relevant individuals
subject to its control) as reasonably requested by, and at the expense of, the
indemnifying Party in the defense of the Loss.

 

If an Indemnitee has complied with all of the conditions described in Sections
12.3(a) – (c), as applicable, the indemnifying Party will supply attorneys
reasonably acceptable to the Indemnitee to defend against any such Loss. 
Subject to the foregoing, an Indemnitee may participate in any proceedings
involving such Loss using attorneys of the Indemnitee’s choice and at the
Indemnitee’s expense.  In no event may an Indemnitee settle or compromise any
Loss for which the Indemnitee intends to seek indemnification from the
indemnifying Party hereunder without the prior written consent of the
indemnifying Party (such consent not to be unreasonably withheld, delayed or
conditioned), or the indemnification under such Section 12.1 or 12.2 as to such
Loss will be null and void.

 

12.4      Limitation of Liability.  EXCEPT FOR INDEMNIFICATION PROTECTION FROM
THE OTHER PARTY PURSUANT TO SECTIONS 12.1 AND 12.2, IN NO EVENT WILL EITHER
PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE
OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR
CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT,
WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT
OF THE AGREEMENT, UNLESS SUCH DAMAGES ARE DUE TO THE GROSS NEGLIGENCE OR WILLFUL
MISCONDUCT OF THE LIABLE PARTY (INCLUDING GROSS NEGLIGENCE OR WILLFUL BREACH
WITH RESPECT TO A PARTY’S REPRESENTATIONS AND WARRANTIES IN ARTICLE 11).

 

12.5      KBI Guarantee.  KBI hereby irrevocably guarantees to Actelion the due
and punctual performance by Kythera of [***] and undertakes, upon the occurrence
and continuance of [***], that KBI will duly and properly [***].  In the event
of Kythera’s failure to fulfill its obligations as described in the previous
sentence, within [***] ([***]) days after the date that Actelion has notified
KBI in

 

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writing of such failure, if Kythera has not [***], KBI shall [***]. In case such
failure at the same time constitutes a material breach of this Agreement
according to Section 10.2 (a), Actelion will have the right to terminate this
Agreement by providing [***] ([***]) days advance written notice only in case
KBI should also [***] within [***] ([***]) days after the date that Actelion has
notified KBI in writing of such failure.

 

13.                            MISCELLANEOUS

 

13.1      Dispute Resolution.

 

(a)          Except for any dispute described in Section 13.3 (which will be
handled exclusively in accordance with Section 13.3), if any dispute,
controversy or claim arises out of, relates to or connects with any provision of
the Agreement (each, a “Disputed Matter”), the Parties will try to settle the
Disputed Matter using informal dispute resolution and by referring the Disputed
Matter to the Party’s respective Executive Officers.  Either Party may initiate
such informal dispute resolution by sending written notice of the dispute to the
other Party, and, within [***] ([***]) days after such notice, such Executive
Officers will meet for attempted resolution by good faith negotiations.  If such
Executive Officers are unable to resolve such Disputed Matter within [***]
([***]) days after their first meeting for such negotiations, the Parties will
resolve their dispute using binding arbitration under Section 13.1(b).

 

(b)          If the Parties are unable to resolve a Disputed Matter using the
process described in Section 13.1(a), then a Party seeking further resolution of
the Disputed Matter will submit the Disputed Matter to resolution by final and
binding arbitration administered by the International Chamber of Commerce, under
the Rules of Arbitration of the International Chamber of Commerce (the “Rules”),
except as otherwise provided herein and applying the substantive law specified
in Section 13.2. Moreover, the Parties agree on the applicability of the “IBA
Rules on the Taking of Evidence in International Commercial Arbitration”.
 Whenever a Party will decide to institute arbitration proceedings, it will give
written notice to that effect to the other Party, and the place of arbitration
will be in Zurich, Switzerland.  The arbitration will be conducted by a panel of
three (3) arbitrators, who will be appointed as follows: each Party will appoint
a single arbitrator, and the two (2) arbitrators will agree on a third (3rd)
arbitrator who will act as the chair of the arbitral tribunal, within ten
(10) days after their appointment.  If the two (2) arbitrators are unable to
agree on the third (3rd) arbitrator within such ten (10) days, then the third
(3rd) arbitrator will be appointed by the International Chamber of Commerce in
accordance with the Rules.  Each arbitrator must have business or legal
experience in the biotechnology or pharmaceutical industry and, in addition, be
knowledgeable in the specific field of dispute in question.  The arbitrators
will not have the power to award damages excluded pursuant to Section 12.4, and
any arbitral award that purports to award such damages is expressly prohibited
and void ab initio.  Decisions of the arbitrators that conform to the terms of
this Section 13.1(b) will be final and binding on the Parties, and enforcement
of the award so rendered may be entered in any court of competent jurisdiction. 
Either Party may apply to the arbitrators for interim injunctive relief until
the arbitration award is rendered or the controversy is otherwise resolved. The
losing Party, as determined by the arbitrators, will pay all of the
administrative costs and fees of the arbitration and the fees and costs of the
arbitrators, and the arbitrators will be directed to provide for payment or
reimbursement of such fees and costs by the losing Party.  If the arbitrators
determine that there is no losing Party, the Parties will each bear

 

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or pay one-half (1/2) of those costs and fees and the arbitrator’s award will so
provide.  Notwithstanding the foregoing, each Party is to bear or pay its own
attorneys’ fees, expert or witness fees, and any other fees and costs, and no
such fees or costs will be shifted to the other Party. Except to the extent
necessary to confirm an award, enforce an award, or as may be required by law,
neither a Party nor the arbitrators may disclose the existence, content, or
results of an arbitration without the prior written consent of the Parties. In
no event shall an arbitration be initiated after the date when commencement of a
legal or equitable proceeding based on the dispute, controversy or claim would
be barred by the laws of Switzerland.

 

13.2      Governing Law.  Resolution of all disputes, controversies or claims
arising out of, relating to or in connection with the Agreement or the
performance, enforcement, breach or termination of the Agreement and any
remedies relating thereto, will be governed by and construed under the
substantive laws of Switzerland, to the exclusion of the UN Convention on
Contracts for the International Sale of Goods, except as described in
Section 8.1(a) where the inventorship of all Sole Inventions and Joint
Inventions will be determined in accordance with the U.S. patent law.

 

13.3      Patents and Trademarks; Equitable Relief.

 

(a)          Any dispute, controversy or claim arising out of, relating to or in
connection with: (i) the scope, validity, enforceability or infringement of any
Patent rights covering the Research, Development, Manufacture or
Commercialization any Licensed Product; or (ii) any trademark rights related to
any Licensed Product, will in each case be submitted to a court of competent
jurisdiction in the territory in which such Patent or trademark rights were
granted or arose.

 

(b)          Any dispute, controversy or claim arising out of, relating to or in
connection with the need to seek preliminary or injunctive measures or other
equitable relief (e.g., in the event of a potential or actual breach of the
confidentiality and non-use provisions in Article 9) need not be resolved
through the procedure described in Section 13.1 but may be immediately brought
in a court of competent jurisdiction.

 

13.4      Entire Agreement; Amendments.  This Agreement sets forth the complete,
final and exclusive agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties
hereto and supersedes and terminates all prior agreements and understandings
between the Parties.  There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties other than as are set forth herein and therein.  No subsequent
alteration or amendment of this Agreement will be binding upon the Parties
unless it is covered in a document that identifies the specific provision that
will be altered or amended, and such document is signed by an authorized officer
of each Party.

 

13.5      Export Control.  This Agreement is made subject to any restrictions
concerning the export of products or technical information from the U.S. or
other countries which may be imposed upon or related to Actelion or Kythera from
time to time.  Each Party agrees that it will not export, directly or
indirectly, any technical information acquired from the other Party under this
Agreement or any products using such technical information to a location or in a
manner that at the time of export requires an export license or other
governmental approval, without first obtaining the written consent to do so from
the appropriate agency or other governmental entity.

 

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3.6         Force Majeure.  Each Party will be excused from the performance of
its obligations under this Agreement to the extent that such performance is
prevented by force majeure (defined below) and the nonperforming Party promptly
provides notice of the prevention to the other Party.  Such excuse will be
continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition.  For
purposes of this Agreement, “force majeure” will include conditions beyond the
control of the Parties, including an act of God, acts of terrorism, compliance
with any regulation, law or order of any government, war, civil commotion, labor
strike or lock-out, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake,
storm or like catastrophe.

 

13.7      Notices.  Any notices given under this Agreement will be in writing,
addressed to the Parties at the following addresses, and delivered by person, by
facsimile (with receipt confirmation), by email (with receipt confirmation), or
by FedEx or other reputable courier service.  Any such notice will be deemed to
have been given: (a) as of the day of personal delivery; (b) one (1) day after
the date sent by confirmed facsimile or confirmed email; or (c) on the day of
successful delivery to the other Party confirmed by the courier service.  Unless
otherwise specified in writing, the mailing addresses of the Parties will be as
described below.

 

For Actelion:                                                           Actelion
Pharmaceuticals, Ltd.
Gewerbestrasse 16
CH-4123 Allschwil
Switzerland
Facsimile No./Email:  [***]
Attention: EVP and Chief Business Development Officer

 

with a copy to (which will not constitute notice):

 

Facsimile No./Email:  [***]
Attention: General Counsel

 

For Kythera:                     Kythera Holdings, Ltd.

Clarendon House

2 Church Street, Hamilton HM 11, Bermuda

Email: bd@kytherabiopharma.com
Attention: Vice President for Strategy and Corporate Development

 

with a copy to (which will not constitute notice):

 

Latham & Watkins LLP
140 Scott Drive
Menlo Park, California 94025
Facsimile No.: (650) 463-2600
Attention: Alan Mendelson, Esq. and Judith Hasko, Esq.

 

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13.8                   Maintenance of Records Required by Law or Regulation. 
Each Party will keep and maintain all records required by applicable law,
rule or regulation with respect to Licensed Products and will make copies of
such records available to the other Party upon request. Each Party retains the
ownership of the documents generated by such Party during the Term.  Records
shall be retained in the format they were generated in and archived for a period
of at least five (5) years or according to applicable rules and regulations if
longer. Any agreement with a sublicensee must include provisions substantially
the same as those contained herein. Kythera will ensure compliance by such
sublicensee with the above record retention obligation. Kythera will keep (and
will ensure that its Affiliates, licensees and sublicensees will keep) such
records as are required by applicable law, rule or regulation.

 

13.9                   Assignment.  Neither Party may assign or transfer this
Agreement without the prior written consent of the other Party (such consent not
to be unreasonably withheld, delayed or conditioned), except a Party may make
such an assignment without the other Party’s consent to an Affiliate or to a
Third Party successor to all or substantially all of the business of such Party
to which this Agreement relates, whether in a merger, sale of stock, sale of
assets or other transaction; provided that any such permitted successor or
assignee of rights and/or obligations hereunder has the financial, technical and
business resources reasonably necessary to perform the obligations of the
assignor (or, in the case of Kythera assigning to an Affiliate, if such
Affiliates performance is guaranteed by KBI in accordance with the terms set
forth in Section 12.5. hereof); provided further that any such permitted
successor or assignee of rights and/or obligations hereunder is obligated, by
reason of operation of law or pursuant to a written agreement with the other
Party, to assume performance of this Agreement or such rights and/or
obligations; and provided, further, that if assigned to an Affiliate, the
assigning Party will remain jointly and severally responsible for the
performance of this Agreement by such Affiliate (unless in the case of Kythera
assigning to an Affiliate, if such Affiliates performance is guaranteed by KBI
in accordance with the terms set forth in Section 12.5 hereof). Any permitted
assignment will be binding on the successors of the assigning Party.  Any
assignment or attempted assignment by either Party in violation of the terms of
this Section 13.9 will be null and void.

 

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

 

13.11           Severability.  If any of the provisions of this Agreement are
held to be invalid or unenforceable, the provision will be considered severed
from this Agreement and will not serve to invalidate any remaining provisions
hereof.  The Parties will make a good faith effort to replace any invalid or
unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be
realized.

 

13.12           No Waiver.  Any delay in enforcing a Party’s rights under this
Agreement or any waiver as to a particular default or other matter will not
constitute a waiver of such Party’s rights to the future enforcement of its
rights under this Agreement, excepting only as to a waiver contained in a
document that identifies the provision that is waived, identifies the period of
time for the waiver, and is signed by the Parties.

 

13.13           Construction of this Agreement.  Except where the context
otherwise requires, wherever used, the use of any gender will be applicable to
all genders, and the word “or” are used

 

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in the inclusive sense.  When used in this Agreement, “including” means
“including without limitation”.  References to either Party include the
successors and permitted assigns of that Party.  The headings of this Agreement
are for convenience of reference only and in no way define, describe, extend or
limit the scope or intent of this Agreement or the intent of any provision
contained in this Agreement.  The Parties have each consulted counsel of their
choice regarding this Agreement, and, accordingly, no provisions of this
Agreement will be construed against either Party on the basis that the Party
drafted this Agreement or any provision thereof.  If the terms of this Agreement
conflict with the terms of any Exhibit, then the terms of this Agreement will
govern.  The official text of this Agreement and any Exhibits hereto, any notice
given or accounts or statements required by this Agreement, and any dispute
proceeding related to or arising hereunder, will be in English.  In the event of
any dispute concerning the construction or meaning of this Agreement, reference
will be made only to this Agreement as written in English and not to any
translation into any other language.

 

13.14           Counterparts.  This Agreement may be executed in two (2) or more
counterparts, each of which will be an original and all of which will constitute
together the same document.  Counterparts may be signed and delivered by
facsimile, or electronically in PDF format, each of which will be binding when
sent.

 

Signature page follows.

 

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IN WITNESS WHEREOF, the Parties have executed this Agreement by their proper
officers.  The date that this Agreement is signed will not be construed to imply
that the document was made effective on that date.

 

ACTELION PHARMACEUTICALS, LTD.,

 

KYTHERA HOLDINGS, LTD.

 

 

 

 

 

 

 

 

 

 

/s/ Nicholas Franco

 

 

/s/ Keith Leonard

 

 

 

 

 

By:

Nicholas Franco

 

By:

Keith Leonard

 

 

 

 

 

Title:

EVP & Chief Business Dev. Officer

 

Title:

Director

 

 

 

 

 

Date:

February 10, 2015

 

Date:

February 10, 2015

 

 

 

 

 

 

 

 

 

 

ACTELION PHARMACEUTICALS, LTD.,

 

Agreed to be bound by the terms and conditions of this Agreement pursuant to
Section 12.5:

 

 

 

 

 

By:

/s/ Douglas B. Snyder

 

KYTHERA BIOPHARMACEUTICALS, INC.

 

 

 

 

 

Title:

General Counsel

 

 

 

 

 

 

 

 

Date:

February 10, 2015

 

By:

Keith Leonard

 

 

 

 

 

 

 

 

Title:_

President and CEO

 

 

 

 

 

 

 

 

Date:

February 10, 2015

 

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Exhibit 1.2

 

Actelion Licensed Patents

 

ACT-[***] Patent Portfolio (Status: October 2014)

 

Case

Act [***]

ACT-[***]

 

 

 

 

 

Publ.

[***]

[***]

 

 

Title

[***]

 

 

 

 

Country

Application No

Appl. Date

Grant No

Grant Date

Status

 

 

 

 

 

 

[***]

[***]

[***]

[***]

[***]

[***]

 

1

 

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with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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[***]

[***]

[***]

[***]

[***]

[***]

 

2

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Exhibit 2.1

 

Process of Technology Transfer of

Actelion Licensed Know-How (including specified Manufacturing know-how) and
Materials

 

Phase

Key Activities and Outputs

1)[***]

 

Estimated Timing:

[***]

 

 

 

 

 

 

 

 

 

 

The purpose of Phase 1 and the activities described below is to [***]. To this
end, within [***] days of License Agreement execution:

[***]

2) [***]

 

Estimated Timing:

[***]

 

 

 

The purpose of Phase 2 and the activities described below is for Actelion to
[***]. To this end:

[***]

3) [***]

 

Estimated Timing:

[***]

The purpose of Phase 3 is to [***].

4) [***]

 

Estimated Timing:

[***]

The purpose of Phase 4 is for [***].

5) [***]

 

Timing: [***]

 

 

The purpose of Phase 5 is for [***].

 

1

 

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requested with respect to the omitted portions.

 

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Know-How and Materials to be Transferred within 30 days or as otherwise
determined hereinafter*

 

Function

Know-How / Materials to be Transferred

In Data
Room?

General

·                 [***]

 

N/A

 

·                 [***]

No

Research & Nonclinical

·                 [***]

No

Regulatory

·                 [***]

No

 

·                 [***]

 

 

No

Clinical

·                 [***]

 

Incomplete

CMC

·                 [***]

 

No

 

[***]

No

 

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requested with respect to the omitted portions.

 

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Know-How and Materials to be discussed for transfer under phase 2: [***]

 

 

Function

Know-How / Materials to be Transferred

In Data
Room?

General

·                 [***]

 

 

No

 

·                 [***]

 

N/A

Research & Nonclinical

·                 [***]

o                [***]

 

 

No

 

o                [***]

N/A

 

o                [***]

 

N/A

Regulatory

·                 [***]

Incomplete

 

Clinical

·                 [***]

Incomplete

 

·                 [***]

No

CMC

[***]

 

 

·                 [***]

Incomplete

 

·                 [***]

 

No

 

·                 [***]

 

Incomplete

 

·                 [***]

o                [***]

No

 

[***] Certain information in this document has been omitted and filed separately
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requested with respect to the omitted portions.

 

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o                [***]

 

Incomplete

 

o                [***]

Incomplete

 

o                [***]

Incomplete

 

o                [***]

 

No

 

·                 [***]

 

N/A

 

·                 [***]

 

N/A

* [***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Know-How and Materials to be discussed for transfer under phases 3, 4 and 5 (may
in some points be redundant with previous section (transfer under phase 2)*

Function

Know-How / Materials to be Transferred

In Data
Room?

General

·                 [***]

 

No

Nonclinical

·                 [***]

No

Clinical

·                 [***]

·                 [***]

·                 [***]

No

 

·                 [***]

No

CMC

[***]

No

 

·                 [***]

 

 

·                 [***]

No

 

·                 [***]

o                [***]

Incomplete

 

o                [***]

 

Incomplete

 

o                [***]

No

 

o                [***]

No

 

o                [***]

Incomplete

 

o                [***]

No

 

o                [***]

Incomplete

 

o                [***]

Incomplete

 

o                [***]

No

 

o                [***]

No

 

o                [***]

No

 

o                [***]

 

No

 

o                [***]

 

 

Incomplete

* [***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Exhibit 2.2 (a)(i)

 

Regulatory Documents to be provided in format other than eCTD

 

Tables, Listings and Figures for all clinical studies will be provided in rich
text format (rtf).

 

The following setipiprant documents will be provided in Microsoft Word format:

 

IND Section Number

Document Title

eCTD Sequence Number

[***]

[***]

[***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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[***]

[***]

[***]

N/A = Not Applicable

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Exhibit 3.1(b)

 

Form of Semi - Annual Development Report

 

Period: MM/YY – MM/YY

 

1. Planned Development and Regulatory Timelines:

Licensed
Compound

Planned Proof of
Concept Trial Initiation
(MM/YY)

Planned Phase III Initiation
(MM/YY)

Planned 1st Regulatory Filing
(MM/YY)

 

 

 

 

 

2. Development Updates:

Licensed
Compound

 

Indication

Phase

New / Ongoing Trial?

Results

 

 

 

 

 

 

3. Regulatory Updates:

Licensed
Compound

Indication

Regulatory Status
(Filed, Approved)

 

Major changes in Regulatory Status during Period

 

 

US

Europe

Japan

 

 

 

 

 

 

 

 

4. Explanation for any deviation from Planned Development or Regulatory
Timelines

Licensed
Compound

 

Indication

Comments

 

 

 

 

5. Publication Updates:

Licensed
Compound

 

Indication

Publication Reference

 

 

 

 

6. Commercialization Update:

Licensed
Compound

 

Comments

 

 

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Exhibit 5.2

 

Items of Manufacturing Information transferred

 

Activity

Description

Analytical Method Transfer

[***]

API Process Transfer

[***]

Drug Product (capsules, tablets, active and placebo) Process Transfer

[***]

Transfer of material

[***]

Container closure systems

[***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Project Management

[***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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Exhibit 9.5

 

Press Release

 

KYTHERA Acquires Worldwide Rights to Clinical Compound and Key Intellectual
Property for Potential Novel Treatment of Hair Loss

 

Westlake Village, Calif., XX, 2015 – KYTHERA Biopharmaceuticals, Inc. (NASDAQ:
KYTH) today announced that it has entered into license agreements with Actelion
Pharmaceuticals Ltd. and the University of Pennsylvania for a novel approach for
the treatment of hair loss, which together could allow KYTHERA to bring a new
treatment to the very large and still highly unsatisfied hair loss market.

 

“These two licenses build on KYTHERA’s focus on developing and commercializing
high-value, self-pay aesthetic products that have the promise to yield high
patient satisfaction and enhanced self image,” said Keith Leonard, KYTHERA’s
president and CEO. “Based on several years of research and clinical work already
accomplished, we believe we have the possibility of reaching initial
proof-of-concept data in a very capital efficient manner.”

 

Under the terms of the agreement with Actelion, KYTHERA Holdings Ltd., a
wholly-owned Bermuda subsidiary of KYTHERA Biopharmaceuticals, Inc., will
license the worldwide rights to setipiprant, a clinical-stage selective and
potent oral antagonist to the prostaglandin D2 (PGD2) receptor. As part of the
agreement, Actelion will be eligible to receive up to $27 million in potential
development and regulatory milestones, as well as royalties on sales if
setipiprant is successfully commercialized.

 

Under the terms of the agreement with the University of Pennsylvania, KYTHERA
Holdings Ltd., will acquire exclusive worldwide rights to the University of
Pennsylvania’s patent estate covering the use of PGD2 receptor antagonists for
the treatment of hair loss (often presenting as male pattern baldness, or
androgenic alopecia). The discovery of the relationship between PGD2 and hair
loss was made in the lab of Dr. George Cotsarelis and published in late 20111.
KYTHERA has been working with Dr. Cotsarelis’ labs at the University of
Pennsylvania over the last two years under Sponsored Research and Option
Agreements to further develop and elucidate the initial reported observations.

 

“The University of Pennsylvania’s discovery and patent estate combined with
access to the PGD2 antagonist setipiprant provide KYTHERA a strong foundation
for this novel approach to hair loss. These observations are potentially the
most innovative new thinking in hair loss over the last two decades,” said
Frederick Beddingfield, III, M.D., Ph.D., KYTHERA’s Chief Medical Officer.
“Setipiprant is believed to directly affect this hair loss pathway, and our own
preclinical and human hair models confirmed this effect. It is a
well-characterized molecule with a large safety database and we believe we can
quickly initiate a development program to study it in hair loss. Putting these
two pieces of the puzzle together is ideal and represents an example of our
approach to scientifically sound and efficient drug development.”

 

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1  Science Translational Medicine, Med 21 March 2012:Vol. 4, Issue 126, p.
126ra34

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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CONFIDENTIAL INFORMATION

EXECUTION COPY

KYTHERA plans to conduct a human proof-of-concept study to establish the
efficacy of setipiprant in male subjects with androgenic alopecia (AGA).

 

About Setipiprant

 

Setipiprant is a selective oral antagonist to the prostaglandin D2 (PGD2)
receptor. The elevation of PGD2 levels in certain regions of the male scalp is
associated with hair loss in those regions. In early research studies,
PGD2 inhibitors were found to extend the anagen (growth) phase of the hair
cycle, thereby promoting the growth of hair.

 

Setipiprant had previously been studied as a potential allergic inflammation
treatment and had undergone eight clinical trials, including a Phase III study
in seasonal allergic rhinitis patients and a Phase II proof of concept study in
asthma patients, resulting in a safety database of more than 1,000 patients.
Actelion suspended the development of setipiprant due to a lack of efficacy seen
in clinical trials for inflammatory disorders.  Treatment in all studies was
well tolerated across all treatment groups and no serious adverse events were
reported.

 

About KYTHERA Biopharmaceuticals, Inc.

 

KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of novel
prescription products for the aesthetic medicine market. KYTHERA’s lead product
candidate, ATX-101, is currently in late-stage clinical development for the
reduction of submental fat, which commonly presents as a double chin, and is a
potential first-in-class submental contouring injectable drug. KYTHERA submitted
its New Drug Application for ATX-101 in May 2014, and will have a Prescription
Drug User Fee Act (PDUFA) action date of May 13, 2015. KYTHERA also maintains an
active research interest in hair and fat biology, pigmentation modulation and
facial contouring. Find more information at www.kytherabiopharma.com.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

 

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