Exhibit 10.41
EXECUTION COPY
Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

                                                

EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
NOVARTIS PHARMA AG
DATED    
AUGUST 28, 2015

    

Amgen Ref. No. 2015641252

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Securities and Exchange Commission.

Table of Contents

1.Definitions    1
2.Option    18
2.1.Option for Franchise Product 3.    18
2.2.Effect of Option Period Expiration.    19
2.3.Development Prior to Option Exercise Date    19
3.Collaboration Scope and Governance    19
3.1.Conduct of the Collaboration    19
3.2.Committees and Teams    20
3.3.Committee Co-Chairs    21
3.4.Committee Meetings    21
3.5.Decision Making    22
3.6.Interactions Between the Joint Management Committee, the Joint Steering
Committee, and Joint Project Teams    23
3.7.Alliance Managers    24
3.8.Outside the Territory    24
4.Grant of License    24
4.1.Licensed Amgen Patents and Know-How    24
4.2.Licensed Novartis Know-How and Patents    25
4.3.Sublicensing    25
4.4.Provision of Know-How    26
4.5.Trademarks    26
4.6.Trademark and Housemark Quality Standards    27
4.7.Domain Names    27
4.8.Retained Rights and Limitations    28
5.Development and Regulatory    28
5.1.Responsibility for Development    28
5.2.Development Within and Outside Development Plan    28
5.3.Development Outside the Territory by Novartis or Inside the Territory by
Amgen    29
5.4.Regulatory Matters    29
5.5.Safety Matters    32
5.6.Cooperation Generally    32
6.Commercialization    33

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Table of Contents

6.1.Operational Control    33
6.2.Promotional Materials    33
6.3.Commercialization Outside the Territory    33
6.4.Reimportation    33
6.5.Cooperation Generally    34
6.6.[*]    34
7.Diligence; Activities Outside the Collaboration    34
7.1.Commercially Reasonable Efforts    34
7.2.Activities Outside the Collaboration    34
7.3.Post-Effective Date Affiliates    34
7.4.    Termination or Divestiture    34
8.Manufacture and Supply    35
8.1.Manufacturing Rights    35
8.2.Supply    35
8.3.Quality Agreement    35
8.4.Responsibility for Regulatory Filings with Respect to Manufacturing;
Inspections of Manufacturing Facilities    36
9.Payment    36
9.1.Royalty Payments    36
9.2.Royalty Reduction    37
9.3.[Reserved].    38
9.4.Appropriate Measure of Value    38
9.5.Reports    38
9.6.No Wrongful Reductions    39
9.7.Development Cost Sharing    39
9.8.Sublicense Payments    41
9.9.[Reserved    41
9.10.Payment Method    42
9.11.Audits    42
9.12.Blocked Currency    43
9.13.Taxes    43
9.14.Withholding    43

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Table of Contents

9.15.VAT    43
9.16.Late Payment    43
10.Intellectual Property    44
10.1.Ownership and Cooperation    44
10.2.Prosecution and Maintenance    44
10.3.Defense and Settlement of Third Party Claims    46
10.4.Enforcement    48
10.5.Cooperation    49
10.6.Allocation of Recoveries    50
10.7.Patent Term Extensions    50
10.8.Employee Agreements    50
11.Confidentiality and Publications    51
11.1.Confidentiality; Exceptions    51
11.2.Authorized Disclosure    51
11.3.Use of Confidential Information and Data with Distracting Programs    52
11.4.Terms and Conditions Confidential    52
11.5.Prior Agreement    53
11.6.Publications and Presentations    53
11.7.Scientific Papers, Abstracts and Posters    53
11.8.Deferral of Disclosures    55
11.9.Failure to Object to Disclosure    55
11.10.Attorney-Client Privilege    55
12.Representations, Warranties and Covenants    55
12.1.Mutual Representations and Warranties    55
12.2.Amgen Representations and Warranties    56
12.3.Disclaimer of Warranties    57
12.4.Covenants    57
13.Limitations of Liability; Insurance    59
13.1.Limitations of Liability    59
13.2.Insurance    59
14.Indemnification    59
14.1.Indemnity    59

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Table of Contents

14.2.Claim for Indemnification    61
15.Term and Termination    61
15.1.Term    62
15.2.Termination    62
15.3.Effect of Termination    63
15.4.Additional Surviving Provisions    65
15.5.Transition Period    65
16.Miscellaneous    65
16.1.Affiliates    66
16.2.Assignment    66
16.3.Governing Law; Jurisdiction    66
16.4.Construction    66
16.5.Counterparts    67
16.6.[Reserved].    67
16.7.Entire Agreement    67
16.8.Force Majeure    67
16.9.Further Assurances    67
16.10.Headings    67
16.11.No Set-Off    67
16.12.Notices    67
16.13.Relationship of the Parties    68
16.14.Severability    68
16.15.Third Party Beneficiaries    68
16.16.Waivers and Modifications    69

SCHEDULES
Clinical Supply
Commercial Supply
Licensed Amgen Patents
Out-of-Pocket Development Expenses
Press Release

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EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT

PREAMBLE
This Exclusive License and Collaboration Agreement (this “Agreement”), effective
as of August 28, 2015 (the “Effective Date”), is by and between Amgen Inc., a
Delaware corporation having its principal place of business at One Amgen Center
Drive, Thousand Oaks, California 91320-1799, U.S.A. (“Amgen”), and Novartis
Pharma AG, a Swiss company having its principal place of business at
Lichtstrasse 35, CH-4056 Basel, Switzerland (“Novartis”). Amgen and Novartis are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties.”
RECITALS
WHEREAS, Amgen is a global biopharmaceutical company that researches, develops,
manufactures and commercializes novel therapeutics to treat grievous illness;
WHEREAS, Amgen is Developing its proprietary monoclonal antibody against
calcitonin gene-related peptide (CGRP) receptor, known as AMG 334 (“Franchise
Product 1”); its proprietary pituitary adenylate cyclase activating peptide
(PACAP) receptor antibody, known as AMG 301 (“Franchise Product 2”); and [*]
(“Franchise Product 3”);
WHEREAS, Novartis has existing development and commercialization capabilities in
the Territory; and
WHEREAS, Amgen wishes to collaborate with Novartis, and Novartis wishes to
collaborate with Amgen, in each case with respect to the Development and
Commercialization of the Licensed Products in the Field in the Territory (each
as defined below) in accordance with the terms and conditions hereof.
NOW, THEREFORE, in consideration of the mutual promises contained herein, and
for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, and intending to be legally bound, the Parties hereto
agree as follows:

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1.
DEFINITIONS

1.1.
“Accounting Standards” means, with respect to Amgen, United States Generally
Accepted Accounting Principles (“U.S. GAAP”), and means, with respect to
Novartis, the International Financial Reporting Standards (“IFRS”), in each
case, as generally and consistently applied throughout the applicable Party’s
organization. Each Party shall promptly notify the other in the event that it
changes the Accounting Standards pursuant to which its records are maintained;
provided, however, that each Party may only use internationally recognized
accounting principles (e.g. IFRS, U.S. GAAP, etc.).

1.2.
“Affiliate” means, with respect to a Party, any Person which controls, is
controlled by or is under common control with such Party. For purposes of this
definition and Section 1.139 only, “control” means the actual power, either
directly or indirectly through one or more intermediaries, to direct or cause
the direction of the management and policies of such Person, whether by the
ownership of 50% or more (or if less than 50%, the maximum ownership interest
permitted by applicable Law) of the securities entitled to be voted generally or
in the election of directors of such Person, or by contract or otherwise. For
purposes of this Agreement, [*] shall be deemed not to be an Affiliate of
Novartis.

1.3.
“Agreement” has the meaning set forth in the Preamble.

1.4.
“Alliance Managers” has the meaning set forth in Section 3.7 (Alliance
Managers).

1.5.
“Amgen” has the meaning set forth in the Preamble.

1.6.
“Amgen Development Costs” means the Development Costs incurred by Amgen and its
Affiliates.

1.7.
“Amgen Development Data” means, with respect to a given Licensed Product, the
preclinical and clinical data generated by or on behalf or in possession of
Amgen or its Affiliates (both within and outside the Territory) in the course of
its preclinical and clinical Development of such Licensed Product, both before
and after the Effective Date of this Agreement other than Amgen [*] Data. For
the avoidance of doubt, Amgen Development Data excludes Novartis Development
Data. All preclinical and clinical data generated pursuant to this Agreement by
or on behalf of Amgen and its Affiliates to obtain, maintain and expand the
Regulatory Approval for such Licensed Product outside of the Territory in
accordance with the Development Plan shall be deemed Amgen Development Data.

1.8.
“Amgen Housemarks” means (i) the corporate logo of Amgen, (ii) the trademark
“Amgen”, (iii) any other trademark, trade name or service mark (whether
registered or unregistered) containing the word “Amgen”, and (iv) any other
trademark or service mark associated with goods or services of Amgen or its
Affiliates, but excluding the Licensed Amgen Trademarks, Licensed Novartis
Trademarks, Novartis Housemarks and trademarks, trade names or service marks
associated with goods or services outside the scope of this Agreement; and all
intellectual property rights residing in any of the foregoing.

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1.9.
“Amgen [*] Data” means, with respect to a given Licensed Product, the
preclinical and clinical data generated by or on behalf of Amgen or its
Affiliates in the course of its preclinical (if any) and clinical Development of
such Licensed Product on or after the Effective Date of this Agreement, which
Development is [*] and which [*].

1.10.
“Amgen Indemnitees” has the meaning set forth in Section 14.1 (Indemnity).

1.11.
“Annual Development Budget” means, with respect to a given Calendar Year and a
given Licensed Product, the amount apportioned for such Calendar Year and such
Licensed Product in the Development Budget, as such budget may be revised from
time to time by mutual agreement of the Parties.

1.12.
“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended,
the UK Bribery Act 2010, as amended, and any other applicable laws, rules and
regulations relating to or concerning public or commercial bribery or
corruption.

1.13.
“Biosimilar Product” means, with respect to a given Licensed Product in a given
country in the Territory, after Regulatory Approval of such Licensed Product in
such country, any other biological product designated for human use which (i)
contains the same principal molecular structural features as (but not
necessarily all of the same structural features as) such Licensed Product,
(ii) has a purity, potency and safety profile that has no clinically meaningful
difference from the purity, potency and safety profile of such Licensed Product,
and (iii) is approved for use pursuant to a regulatory approval process in such
country that is based on reliance, at least in part, on an unrelated party’s
previously approved  version of that same product (i.e., a product meeting the
standards set forth in the foregoing clauses (i) and (ii)), whether or not such
regulatory approval was based upon data generated by the Parties filed with the
applicable Governmental Authority in such country or was obtained using an
abbreviated, expedited or other process, and (iv) is sold in such country by any
Third Party.

1.14.
“BLA” means a Biologic Licensing Application, including all supplements and
amendments thereto, for the approval of a Licensed Product as a new drug by the
FDA.

1.15.
“Business Day” means a day that is not a Saturday, a Sunday or a day on which
banking institutions in New York, New York, USA, or Basel, Switzerland, are
authorized by applicable Law to remain closed.

1.16.
“Calendar Quarter” means a three-month period beginning on January, April, July
or October 1st.

1.17.
“Calendar Year” means a one-year period beginning on January 1st and ending on
December 31st.

1.18.
“Claims” has the meaning set forth in Section 14.1 (Indemnity).

1.19.
“Clinical Trial” means a Phase 1 Clinical Trial, a Phase 2 Clinical Trial, a
Phase 3 Clinical Trial, a Phase 3b Clinical Trial or a Phase 4 Clinical Trial.

1.20.
“Co-Chair” has the meaning set forth in Section 3.3 (Committee Co-Chairs).

1.21.
“Collaboration” has the meaning set forth in Section 3.1 (Conduct of the
Collaboration).

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1.22.
“Commercialize” means any and all processes and activities conducted to
establish and maintain sales for a Licensed Product, including to market,
advertise, promote, store, transport, distribute, import, export, offer to sell
(including pricing and reimbursement activities), detail, and/or sell Licensed
Products and/or conduct other commercialization activities, and
“Commercialization” shall have the correlative meaning with respect to such
activities; provided, however, that Commercialize shall exclude Medical Affairs
Activities and Development and Manufacturing activities (including Manufacturing
activities related to Commercialization).

1.23.
“[*]” has the meaning set forth in Section [*].

1.24.
“Commercially Reasonable Efforts” means, with respect to the efforts to be
expended by a Party with respect to any objective under this Agreement,
reasonable, diligent, good-faith efforts to accomplish such objective as [*]
would normally use to accomplish a similar objective under similar
circumstances, it being understood and agreed that, with respect to the
Manufacture, Development, conduct of Medical Affairs Activities with respect to,
and Commercialization of a Licensed Product, such efforts shall be substantially
equivalent to those efforts and resources commonly used by [*] for a product
owned by it or to which it has rights, which product is of similar market and
economic potential as the Licensed Product, and at a similar stage in its
Development or product life as the Licensed Product, taking into account
efficacy, safety, approved labeling, the competitiveness of alternative products
in the marketplace, the patent and other proprietary position of the product,
the likelihood of Regulatory Approval given the regulatory structure involved,
the profitability, and other relevant factors commonly considered in similar
circumstances, in any event exercising reasonable business judgment.  It is
anticipated that the level of effort may change over time, reflecting changes in
the status of the aforementioned attributes and potential of a Licensed Product.

1.25.
“Committee” has the meaning set forth in Section 3.2.3.

1.26.
“Confidential Information” has the meaning set forth in Section 11.1
(Confidentiality; Exceptions).

1.27.
“Contract Interest Rate” means [*] percent ([*]%) plus the [*] day U.S. Dollar
LIBOR rate effective for the date that payment was due, as published by The Wall
Street Journal, Eastern U.S. Edition, on the date such payment was due (or, if
unavailable on such date, the first date thereafter on which such rate is
available), or, if lower, the maximum rate permitted by Law.

1.28.
“Control” means, with respect to any Information or intellectual property, that
the applicable Party or any of its Affiliates owns or has a license to such
Information or intellectual property and has the ability to grant to the other
Party access to and a license or sublicense (as applicable) under such
Information or intellectual property as set forth herein without violating the
terms of any agreement with any Third Party as of the time such Party would
first be required hereunder to grant such access and license or sublicense, or
requiring any payment (whether or not then due and payable) unless the other
Party agrees in writing to be responsible for such payments or it is subject to
Section 9.8 (Sublicense Payments).

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1.29.
“Cover”, “Covered” or “Covering” means, with respect to a product and a Patent,
that, in the absence of a (sub)license under, or ownership of, such Patent, the
making, using, offering for sale, selling or importing of such product with
respect to a given country would infringe a Valid Claim of such Patent.

1.30.
“Critical Matter” means (i) all decisions made by the JSC or JMC that, in the
reasonable opinion of either Party, are likely to have any of the following
impacts: (a) a [*]; or (b) a [*] to a Development Plan or any change to a
Development Plan that results in an increase, or decrease, of [*] percent ([*]%)
or more to the then-current budgeted amount of Development Costs for any
specific Calendar Year under the applicable Development Budget; (ii) agreement
of the initial [*] for each Licensed Product; and (iii) [*] of a Licensed
Product in the Territory [*] relating to a Licensed Product.

1.31.
“Develop” or “Development” means those activities required and/or useful to
obtain and maintain Regulatory Approval, including, without limitation, test
method development and stability testing, assay development and audit
development, pre-clinical/non-clinical studies (including toxicology studies),
formulation, pharmacodynamics, quality assurance/quality control development,
statistical analysis, clinical studies, packaging development, regulatory
affairs, biomarker strategy and development, report writing and statistical
analysis, the preparation, filing and prosecution of MAAs and activities to
obtain international nonproprietary names and other nonproprietary names such as
U.S. Adopted Name (USAN) for pharmaceutical substances; provided, however, that
Development shall exclude Commercialization and Manufacturing activities. For
clarity, Development shall include clinical trials that are required or
requested in writing by a Governmental Authority as a condition of, or in
connection with, obtaining or maintaining Regulatory Approval (whether the trial
is commenced prior to or after receipt of such Regulatory Approval).

1.32.
“Development Budget” means, (i) with respect to each of Franchise Product 1 and
Franchise Product 2, the budget of Development Costs agreed by the Parties with
respect to such product and (ii) with respect to Franchise Product 3, the budget
of Development Costs agreed by the Parties pursuant to Section 2.3 (Development
Prior to Option Exercise Date) or, if not agreed, proposed by Amgen in the
Option Data Package for Franchise Product 3, in each case covering all
activities contemplated by the applicable Development Plan, as such budget may
be updated annually by the JSC in connection with updates to such Development
Plan, as well as the amount of any Study Budgets as applicable for the
applicable Licensed Product. The Development Budget shall include (with respect
to Franchise Product 3, at the time of delivery of the Option Data Package) such
aggregate budget of Development Costs and the estimated apportionment of such
aggregate budget for each Calendar Year (or portion thereof) within the period
covered by the Development Plan. The initial Development Budgets for each of
Franchise Product 1 and Franchise Product 2 shall be agreed in writing by the
Parties on the Effective Date. For the avoidance of doubt, the Development
Budget shall cover all activities contemplated by the applicable Development
Plan for the entire period thereof.

1.33.
“Development Costs” means the direct costs incurred by a Party and its
Affiliates during the Term and pursuant to this Agreement for the Development of
a Licensed Product(s), calculated as the sum of (i) Out-of-Pocket Development
Expenses, (ii) Development FTE

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Costs and (iii) Other Development Expenses, each only to the extent incurred in
accordance with the Development Plan and Development Budget after the Effective
Date.  For clarity, “Development Costs” does not include any costs associated
with conducting any Phase 4 Clinical Trials unless the Parties otherwise agree
to include a Phase 4 Clinical Trial in the Development Plan.
1.34.
“Development FTE Costs” means the product of (i) the actual number of FTEs
utilized in the Development of a Licensed Product(s) in accordance with the
Development Plan and Development Budget after the Effective Date, as documented
by the applicable Party using a reliable time tracking system and (ii) the FTE
Rate.

1.35.
“Development Plan” means, with respect to a given Licensed Product, the plan,
including any Study Plan, for such Licensed Product in the Field (which plan
will be updated annually by the JSC and will cover a period of at least [*]
years) covering: (i) the research and Development of, and conduct of Medical
Affairs Activities with respect to, such Licensed Product, including relating to
biomarkers and including observational research and payer evidence generation
including economic value; (ii) the then current target product profile of such
Licensed Product; (iii) the preparation and submission of Regulatory Filings for
such Licensed Product; and (iv) obtaining, maintenance and expansion of
Regulatory Approvals for such Licensed Product in the Field. The initial
Development Plans for each of Franchise Product 1 and Franchise Product 2 shall
be agreed in writing by the Parties on the Effective Date.

1.36.
“Distracting Product” means any [*] that [*] as a Licensed Product (i.e., [*]
(excluding the Licensed Products and, in the case of Amgen only, Franchise
Product 3, but including [*])).

1.37.
“Distracting Program” means the clinical development, commercialization or
manufacture of any Distracting Product.

1.38.
“Distracting Transaction” means any transaction entered into by Novartis or its
Affiliate or Amgen or its Affiliate after the Effective Date whereby a Third
Party that is engaged in a Distracting Program becomes an Affiliate of such
Party.

1.39.
“Distracting Transaction Affiliates” means those entities that are or would
become Affiliates of a Party by virtue of a Distracting Transaction.

1.40.
“Divest” means, with respect to any Distracting Program, the sale, exclusive
license or other transfer of all of the right, title and interest in and to such
Distracting Program, including technology, Information, intellectual property
and other assets materially relating thereto, to an independent Third Party,
without the retention or reservation of any rights or interest (other than
solely an economic interest) in such Distracting Program by a Party or its
Affiliates.

1.41.
“Dollars” or “$” means U.S. Dollars.

1.42.
“Domain Name(s)” means a string of typographic characters used to describe the
location of a specific location on the Internet.

1.43.
“Effective Date” has the meaning set forth in the Preamble.

1.44.
“EMA” means the European Medicines Agency, and any successor agency thereto.

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1.45.
“European Union” or “EU” means those countries, nations, states or other
territories under the jurisdiction of the EMA, as such jurisdiction may change
from time to time.

1.46.
“FDA” means the U.S. Food and Drug Administration, and any successor agency
thereto.

1.47.
“Field” means any and all uses for the diagnosis, prevention or treatment of any
disease or condition in all indications in humans.

1.48.
“[*] Royalty Floor Restriction” has the meaning set forth in Section 9.2.2
(Third Party Payments).

1.49.
“First Commercial Sale” means, with respect to a given Licensed Product, on a
country-by-country basis, the first sale in such country in the Territory to a
Third Party of such Licensed Product by or under the authority of Novartis or
its Affiliate or sublicensee after receipt of the applicable Regulatory
Approval. Sales for clinical study purposes or compassionate, named patient or
similar use shall not constitute a First Commercial Sale.

1.50.
“Force Majeure” has the meaning set forth in Section 16.8 (Force Majeure).

1.51.
“Franchise Product 1” has the meaning set forth in the Recitals.

1.52.
“Franchise Product 2” has the meaning set forth in the Recitals.

1.53.
“Franchise Product 2 Study” means the Phase 2a Clinical Trial for Franchise
Product 2 designed to evaluate the safety and efficacy of Franchise Product 2 in
patients with [*].

1.54.
“Franchise Product 2 Study Readout” means the Franchise Product 2 Study [*] data
[*] following database lock of the Franchise Product 2 Study.

1.55.
“Franchise Product 3” has the meaning set forth in the Recitals.

1.56.
“Franchise Product 3 Study” means the Phase 1 Clinical Trial for Franchise
Product 3 designed to evaluate the safety of Franchise Product 3 in healthy
subjects and [*].

1.57.
“Franchise Product 3 Study Readout” means the Franchise Product 3 Study [*] data
[*] following database lock of the Franchise Product 3 Study.

1.58.
“Franchise Product 3 [*] Data Package” means the data package presented to [*]
for purposes of [*] with respect to [*], which shall include [*].

1.59.
“FTE” means a full-time equivalent person (i.e., one fully-dedicated or multiple
partially-dedicated employees aggregating to one full-time employee employed or
contracted by Amgen or Novartis based upon a total of [*] days or [*] hours per
year undertaken in connection with the conduct of Development in accordance with
the Development Plan). Overtime, and work on weekends, holidays and the like [*]
be counted [*] toward the number of hours that are used to calculate the FTE
contribution.

1.60.
“FTE Rate” means $[*] per FTE per year (as of the Effective Date), increasing by
[*] percent ([*]%) of the then-current FTE Rate on January 1st of [*] and each
subsequent Calendar Year. The FTE Rate includes costs associated with salaries,
payroll taxes, bonuses, benefits, recruiting, relocation, employee stock option
programs or stock grants, retirement programs, and applicable overhead (e.g.,
facilities, operating supplies, travel and training).

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

1.61.
“Global Brand Plan” means, with respect to a given Licensed Product, the
strategic and high-level tactical, cross-functional Commercialization plan
jointly developed by Amgen and Novartis (including through the JSC) for such
Licensed Product, including the Global Payer Plan and the Global Pricing Policy.

1.62.
“Global Payer Plan” means, with respect to a given Licensed Product, the global
plan for such Licensed Product jointly prepared by Amgen and Novartis (including
through the JSC) that sets forth the strategic direction, positioning, value
proposition, [*]), value evidence generation plan, economic modeling strategy
[*] for such Licensed Product.

1.63.
“Global Pricing Policy” means, with respect to a given Licensed Product, the
global plan for such Licensed Product jointly prepared by Amgen and Novartis
(including through the JSC) that sets forth, globally and by region, the
proposed [*] target population and [*] target.

1.64.
“Governmental Authority” means any government administrative agency, commission
or other governmental authority, body or instrumentality, or any federal, state,
local, domestic or foreign governmental regulatory body.

1.65.
“Government Official” means (i) any Person employed by or acting on behalf of a
Governmental Authority; (ii) any political party, party official or candidate;
(iii) any Person who holds or performs the duties of an appointment, office or
position created by custom or convention; and (iv) any Person who holds himself
out to be the authorized intermediary of any of the foregoing.

1.66.
“Housemarks” means the Novartis Housemarks or the Amgen Housemarks, as the case
may be.

1.67.
“IND” means, with respect to the United States, an Investigational New Drug
Application as defined in applicable regulations promulgated by the FDA and
filed with the FDA for human clinical testing of a drug or, with respect any
jurisdiction other than the United States, an equivalent filing thereof.

1.68.
“Indemnified Party” has the meaning set forth in Section 14.2 (Claim for
Indemnification).

1.69.
“Indemnifying Party” has the meaning set forth in Section 14.2 (Claim for
Indemnification).

1.70.
“Information” means all tangible and intangible techniques, information,
technology, practices, trade secrets, inventions (whether patentable or not),
methods, knowledge, know-how, conclusions, skill, experience, test data and
results (including pharmacological, toxicological and clinical test data and
results), analytical and quality control data, results or descriptions, software
and algorithms. “Information” excludes tangible materials, including biological
compounds, chemical compounds, reagents, Trademarks and Housemarks.

1.71.
“Initiation” of a clinical trial or to “Initiate” a clinical trial means the
first dosing of the first human subject with a Licensed Product in such trial.

1.72.
“Insolvency Event” means, with respect to any Party, the occurrence of any of
the following: (i) such Party shall commence a voluntary case concerning itself
under any bankruptcy, liquidation or insolvency code; (ii) an involuntary case
is commenced against such Party and the petition is not dismissed within sixty
(60) days after commencement of the case;

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(iii) a court-supervised custodian is appointed for, or takes charge of, all or
substantially all of the property of such Party or such Party commences any
other proceedings under any reorganization, arrangement, adjustment of debt,
relief of debtors, dissolution, insolvency or liquidation or similar law of any
jurisdiction whether now or hereafter in effect relating to such Party or there
is commenced against such Party any such proceeding which remains undismissed
for a period of sixty (60) days; (iv) any order of relief or other order
approving any such case or proceeding is entered; (v) such Party is adjudicated
insolvent or bankrupt; (vi) such Party suffers any appointment of any
court-appointed custodian, receiver or the like for it or all or substantially
all of its property to continue undischarged or unstayed for a period of sixty
(60) days; (vii) such Party makes a general assignment for the benefit of
creditors; (viii) the governing body or executive management of such Party shall
make a duly authorized statement that it is unable to pay, or shall be unable to
pay, its debts generally as they become due; (ix) such party shall call a
meeting of its creditors generally with a view to arranging a compromise or
adjustment of its debts; or (x) any corporate, limited liability company,
partnership or individual action, as applicable, is taken by such Party for the
specific purpose of effecting any of the foregoing.
1.73.
“[*]” means [*] or any of its Affiliates.

1.74.
“Joint Management Committee” or “JMC” means the executive committee established
pursuant to Article 3 (Collaboration Scope and Governance).

1.75.
“Joint Patents” means any invention, patent or patent application jointly owned
by the Parties pursuant to Section 10.1 (Ownership and Cooperation).

1.76.
“Joint Project Team” or “JPT” has the meaning set forth in Section 3.2.5 (Joint
Project Teams).

1.77.
“Joint Steering Committee” or “JSC” means the steering committee established
pursuant to Article 3 (Collaboration Scope and Governance).

1.78.
“Law” means, individually and collectively, any and all laws, ordinances, rules,
directives, administrative circulars and regulations of any kind whatsoever of
any Governmental Authority within the applicable jurisdiction.

1.79.
“Licensed Amgen Know-How” means, with respect to a given Licensed Product,
Information Controlled by Amgen or its Affiliates, as of the Effective Date or
thereafter during the Term, that is [*] for Novartis to use, research, Develop,
conduct Medical Affairs Activities with respect to or Commercialize such
Licensed Product in the Field in the Territory. Licensed Amgen Know-How shall
include Amgen Development Data that is [*] for Novartis to use, research,
Develop, conduct Medical Affairs Activities with respect to or Commercialize
such Licensed Product in the Field in the Territory.

1.80.
“Licensed Amgen Patents” means, with respect to a given Licensed Product, those
patents and patent applications set forth on the Licensed Amgen Patents
Schedule, as well as any continuation, divisional, substitution,
continuation-in-part, reissue, reexamination, provisional and converted
provisional application thereof, as well as any Patent in the Territory
Controlled by Amgen or its Affiliates on or after the Effective Date (including
an interest in a patent or Joint Patent pursuant to Section 10.1 (Ownership and
Cooperation))

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that (i) would (absent the licenses granted herein) be infringed by the use,
research, Development or Commercialization of, or the conduct of Medical Affairs
Activities with respect to, such Licensed Product in the Field in the Territory
or (ii) would be [*] for the use, research, Development or Commercialization of,
or the conduct of Medical Affairs Activities with respect to, such Licensed
Product in the Field in the Territory. For purposes of determining whether a
patent application falls within clause (i) of this definition, a patent
application shall be considered “infringed” if its pending claims would be
infringed if issued as then currently set forth in the patent application.
1.81.
“Licensed Amgen Patent Schedule” means the schedule of Licensed Amgen Patents
attached hereto, which may be updated by Amgen from time to time upon reasonable
notice to Novartis.

1.82.
“Licensed Amgen Trademarks” means, with respect to a given Licensed Product, any
Trademark rights Controlled by Amgen or its Affiliates in the Territory on or
after the Effective Date and corresponding to any Trademarks adopted by Amgen
for use with such Licensed Product in the Field outside the Territory (not
including any Housemarks, and not including any such marks to the extent such
marks would conflict with any right of any Third Party inside the Territory).

1.83.
“Licensed Novartis Know-How” means, with respect to a given Licensed Product,
Information Controlled, as of the Effective Date or thereafter during the Term,
by Novartis or its Affiliates that is a Novartis Improvement or is [*] for Amgen
to use, research, conduct Medical Affairs Activities with respect to, Develop,
Commercialize or Manufacture such Licensed Product within or outside the
Territory in the Field. Licensed Novartis Know-How shall include Novartis
Development Data other than Novartis [*] Data that is [*] for Amgen to use,
research, Develop, conduct Medical Affairs Activities with respect to,
Commercialize or Manufacture such Licensed Product within or outside the
Territory in the Field.

1.84.
“Licensed Novartis Patents” means, with respect to a given Licensed Product,
those Patents Controlled on or after the Effective Date by Novartis or its
Affiliates (including an interest in a patent or Joint Patent pursuant to
Section 10.1 (Ownership)) that Cover such Licensed Product or Novartis
Improvement and (i) would (absent the licenses granted herein) be infringed by
the use, research, Development or Commercialization or Manufacture of, or the
conduct of Medical Affairs Activities with respect to, such Licensed Product
within or outside the Territory in the Field or (ii) would be [*] for the use,
research, Development, Commercialization or Manufacture of, or the conduct of
Medical Affairs Activities with respect to, such Licensed Product within or
outside the Territory in the Field. For purposes of determining whether a patent
application falls within clause (i) of this definition, a patent application
shall be considered “infringed” if its pending claims would be infringed if
issued as then currently set forth in the patent application.

1.85.
“Licensed Novartis Trademarks” means, with respect to a given Licensed Product,
any Trademarks Controlled and adopted by Novartis or its Affiliates on or after
the Effective Date for use with such Licensed Product in the Field in the
Territory (not including any Housemarks).

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

1.86.
“Licensed Product” means (i) Franchise Product 1, (ii) Franchise Product 2, and
(iii) from and after the Option Exercise Date only, Franchise Product 3.

1.87.
“Liens” means, with respect to any property or asset, any mortgage, pledge,
security interest, license or similar encumbrances (including any conditional
sale or option).

1.88.
“Lifecycle Management” means strategies and activities intended to optimize the
full value of a drug product through its Development and Commercialization
lifecycle.

1.89.
“Losses” has the meaning set forth in Section 14.1 (Indemnity).

1.90.
“MAA” means (i) in the United States, a BLA, and (ii) outside the United States,
an application for the authorization to market a Licensed Product in any country
or group of countries outside the United States, as defined in the applicable
laws and regulations and filed with the Governmental Authority of such country
or group of countries.

1.91.
“Manufacturing” or “Manufacture” means any and all processes and activities
directed to producing, manufacturing, processing, sourcing of materials,
filling, finishing, packaging, labeling, inspecting, quality assurance testing
and release, receiving, holding, shipping and/or storage of a Licensed Product
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, commercial manufacture, stability and
release testing, and quality control.

1.92.
“Material Anti-Corruption Law Violation” means a violation of an Anti-Corruption
Law relating to the subject matter of this Agreement which would if [*] have a
material adverse effect on [*].

1.93.
“Material Safety Issue” means a Party’s good faith belief that [*] based upon
(i) pre-clinical safety data [*] or (ii) [*].

1.94.
“Medical Affairs Activities” means design, strategies, oversight and
implementation of activities designed to ensure or improve appropriate medical
use of, conduct medical education of, or further research regarding, a Licensed
Product, as established by the applicable Party’s internal policies and
procedures, which includes by way of example: (i) activities of Medical
Liaisons; (ii) grants to support continuing independent medical education
(including independent symposia and congresses); and (iii) development,
publication and dissemination of publications in support of an approved
indication for a Licensed Product, as well as medical information services (and
the content thereof) provided in response to inquiries communicated via the
sales representatives or other external-facing representatives or received by
letter, phone call or email.

1.95.
“Medical Journal” has the meaning set forth in Section 11.6.2.

1.96.
“Medical Liaisons” means those health care professionals employed or engaged by
a Party with sufficient health care experience to engage in in-depth dialogues
with physicians regarding medical issues associated with a Licensed Product, and
are not sales representatives or otherwise engaged in direct selling or
promotion of such Licensed Product.

1.97.
“Net Sales” means with respect to a given period and a given Licensed Product,
the gross invoiced sales for such Licensed Product sold by or on behalf of
Novartis or any of its

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Affiliates or sublicensees hereunder to Third Parties other than sublicensees in
bona fide, arms-length transactions, less the following charges or expenses
recorded on an accrual basis, as determined in accordance with Novartis’s
Accounting Standards as consistently applied:
(i) normal trade and cash discounts allowed and taken by the Third Party;
(ii) amounts repaid or credited by reasons of defects, rejections, Recalls or
returns;
(iii) rebates and chargebacks to customers and managed healthcare organizations,
federal, state, provincial, local and other governments, their agencies and
purchasers and reimbursers and similar Third Parties (including, without
limitation, [*]);
(iv) any amounts recorded in gross revenue associated with goods provided to
customers for free;
(v) amounts provided or credited to customers through coupons and other discount
programs;
(vi) delayed ship order credits, discounts or payments related to the impact of
price increases between purchase and shipping dates;
(vii) fee for service payments to customers for any non-separable services
(including compensation for maintaining agreed inventory levels and providing
information);
(viii) following such deductions in (i) through (vii) above, less a deduction of
[*] percent ([*]%) for direct expenses related to the sales of the Licensed
Product, distribution and warehousing expenses and uncollectible amounts on
previously sold products.
In addition, (a) Net Sales only include the value charged or invoiced on the
first arm’s length sale to a Third Party and sales between or among Novartis and
its Affiliates and sublicensees shall be disregarded for purposes of calculating
Net Sales; (b) if a Licensed Product is delivered to the Third Party before
being invoiced (or is not invoiced), Net Sales will be calculated at the time
all the revenue recognition criteria under Novartis’s Accounting Standards are
met; and (c) in the event that the Licensed Product is sold in a given country
together with one or more other therapeutically active ingredients or therapies
not constituting a Licensed Product for a single price (regardless of their
packaging) (a “Combination Product”), such Licensed Product shall be deemed to
be sold in such country for an amount equal to the product of (i) the price at
which the Combination Product was sold in such country and (ii) the fraction
A/(A+B), where A is the weighted (by sales volume) average sale price in such
country during the applicable reporting period of the Licensed Product when sold
alone, and B is the weighted average sale price (by sales volume) in such
country during the applicable reporting period of each other therapeutically
active ingredient or therapy included in the Combination Product when sold
alone. Regarding prices comprised in the weighted average price when sold
separately referred to above, if these are available for different dosages of
the Licensed Product or other therapeutically active ingredients or therapies
than those that are included in the Combination Product, then Novartis shall be
entitled to make a proportional adjustment to such prices in calculating the
royalty-bearing Net Sales of the Combination Product. If the weighted average
sale price cannot be determined for the Licensed Product or other
therapeutically active ingredients or therapies, the calculation of Net Sales
for Combination Products will be agreed by the

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Parties based on the relative fair market value contributed by each component
(each Party’s agreement not to be unreasonably withheld or delayed).
Any disposal of Licensed Product at no charge for, or use of such Licensed
Product without charge in, clinical or preclinical trials shall not be included
in Net Sales.
1.98.
“Novartis” has the meaning set forth in the Preamble.

1.99.
“Novartis Assumed Item” has the meaning set forth in Section 10.2.1.2 (Novartis
Secondary Prosecution).

1.100.
“Novartis Development Costs” means the Development Costs incurred by Novartis
and its Affiliates.

1.101.
“Novartis Development Data” means, with respect to a given Licensed Product, the
preclinical and clinical data generated by or on behalf of Novartis or its
Affiliates in the course of its preclinical (if any) and clinical Development of
such Licensed Product, on or after the Effective Date of this Agreement, other
than Novartis [*] Data. All preclinical and clinical data generated pursuant to
this Agreement by or on behalf of Novartis and its Affiliates to obtain,
maintain and expand the Regulatory Approval for such Licensed Product in the
Territory in accordance with the Development Plan shall be deemed Novartis
Development Data.

1.102.
“Novartis Housemarks” means (i) the corporate logo of Novartis, (ii) the
trademark “Novartis”, (iii) any other trademark, trade name or service mark
(whether registered or unregistered) containing the word “Novartis”, and
(iv) any other trademark or service mark associated with goods or services of
Novartis or its Affiliates, but excluding the Licensed Novartis Trademarks,
Licensed Amgen Trademarks, Amgen Housemarks and trademarks, trade names or
service marks associated with goods or services outside the scope of this
Agreement; and all intellectual property rights residing in any of the
foregoing.

1.103.
“Novartis Improvement” means, with respect to a given Licensed Product, any
improvement, modification, enhancement or novel use of such Licensed Product
that either Covers or specifically relates to such Licensed Product and is
Developed by or on behalf of, or Controlled by, Novartis or its Affiliates
during the Term.

1.104.
“Novartis Indemnitees” has the meaning set forth in Section 14.1 (Indemnity).

1.105.
“Novartis Key Markets” means [*].

1.106.
“Novartis [*] Data” means, with respect to a given Licensed Product, the
preclinical and clinical data generated by or on behalf of Novartis or its
Affiliates in the course of its preclinical (if any) and clinical Development of
such Licensed Product on or after the Effective Date of this Agreement, which
Development is [*] and which [*].

1.107.
“Option” has the meaning set forth in Section 2.1 (Option for Franchise Product
3).

1.108.
“Option Data Package 1” means (i) the Franchise Product 3 [*] Data Package;
(ii) the then-current draft of the IND to be filed with FDA or EMA for Franchise
Product 3 that includes the [*]; (iii) the then-current plan and budget for
Development for Franchise Product 3; and (iv) the status of the prosecution of
all Licensed Amgen Patents with respect to Franchise Product 3.

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1.109.
“Option Data Package 2” means (i) the Franchise Product 3 Study Readout;
(ii) the Franchise Product 2 Study Readout; (iii) the then-current plan and
budget for Development for Franchise Product 3; and (iv) the status of the
prosecution of all Licensed Amgen Patents with respect to Franchise Product 3.

1.110.
“Option Exercise Date” means the date on which Novartis has delivered to Amgen
an Option Exercise Notice in accordance with Section 2.1 (Option for Franchise
Product 3).

1.111.
“Option Exercise Notice” has the meaning set forth in Section 2.1 (Option for
Franchise Product 3).

1.112.
“Option Period” means the period beginning on the date that Amgen provides
Option Data Package 1 to Novartis, and expiring upon the expiration of Option
Period 2.

1.113.
“Option Period 1” means the period beginning on the date that Amgen provides
Option Data Package 1 to Novartis, and expiring upon the earliest of (i) [*]
days after [*] for Franchise Product 3, (ii) the Option Exercise Date and
(iii) termination of this Agreement.

1.114.
“Option Period 2” means the period beginning on the date that Amgen provides
Option Data Package 2 to Novartis, and expiring upon the earliest of (i) [*]
days after delivery of Option Data Package 2, (ii) the Option Exercise Date and
(iii) termination of this Agreement.

1.115.
“Other Development Expenses” means any other expenses incurred for clinical
materials, analytical services or other items to the extent in the Development
Plan and Development Budget.

1.116.
“Other Development Plan Opt-In Right” has the meaning set forth in Section 5.2.2
(Development Outside the Current Development Plan).

1.117.
“Out-of-Pocket Development Expenses” means direct expenses paid or payable to
Third Parties which are specifically identifiable and incurred by a Party and
its Affiliates for the Development of Licensed Product(s), including the
expenses set forth on the Out-of-Pocket Development Expenses Schedule; provided
that such expenses shall have been recorded as income statement items in
accordance with such Party’s Accounting Standards and shall not include any
pre-paid amounts, capital expenditures, or items intended to be covered by the
FTE Rate.

1.118.
“Patent” means any of the following, whether existing now or in the future,
anywhere in the world: (i) any patents and patent applications (including
provisional applications); (ii) any patent applications filed either from such
patents or patent applications (including provisional applications) or from an
application claiming priority from either of these, including continuations,
continuations-in-part, divisionals, converted provisionals, continued
prosecution applications, and substitute applications; (iii) any patents issued
based on or claiming priority to any such patent applications in (i) and (ii);
(iv) any and all extensions or restorations by existing or future extension or
restoration mechanisms, including adjustments, revalidations, renewals,
reissues, re-examinations and extensions (including any supplementary protection
certificates and the like) of the foregoing patents or patent applications in
(i), (ii) and (iii); and (v) any similar rights, including so-called pipeline
protection, or any importation, revalidation, confirmation or introduction
patent

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or registration patent or patents of addition to any of such foregoing patents
or patent applications.
1.119.
“Party” or “Parties” has the meaning set forth in the Preamble.

1.120.
“Patent and Trademark Matters” has the meaning set forth in Section 10.2.1.1
(Amgen Primary Prosecution).

1.121.
“Pediatric Investigational Plan” means a required plan for the investigation of
the drug/biologic compound in the pediatric population submitted to and approved
by the EMA.

1.122.
“Person” means an individual, corporation, partnership, limited liability
company, limited partnership, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, “group” as defined in Section 13(d)(3)
of the U.S. Securities Exchange Act of 1934, as amended, sole proprietorship,
unincorporated organization, Governmental Authority or any other form of entity
not specifically listed herein.

1.123.
“Phase 1 Clinical Trial” means, with respect to the United States, a clinical
trial of a product that meets the definition of a Phase 1 study as described
under 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the
United States, an equivalent clinical trial.

1.124.
“Phase 2 Clinical Trial” means a Phase 2a Clinical Trial or a Phase 2b Clinical
Trial.

1.125.
“Phase 2a Clinical Trial” means, with respect to the United States, a clinical
trial of a product that utilizes the pharmacokinetic and pharmacodynamic
information obtained from one or more previously conducted Phase 1 Clinical
Trial(s) and/or other Phase 2a Clinical Trial(s) in order to confirm the optimal
manner of use of such product (dose and dose regimens) and to further evaluate
safety and efficacy, as described under 21 C.F.R. §312.21(b), or, with respect
to a jurisdiction other than the United States, an equivalent clinical trial.

1.126.
“Phase 2b Clinical Trial” means, with respect to the United States, a clinical
trial of a product, designed to support and precede the Initiation of a Phase 3
Clinical Trial program, on sufficient numbers of patients that is designed to
provide a preliminary determination of safety and efficacy of such product in
the target patient population over a range of doses and dose regimens, as
described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other
than the United States, an equivalent clinical trial.

1.127.
“Phase 3 Clinical Trial” means, with respect to the United States, a clinical
trial of a product on sufficient numbers of patients that is designed to
establish that such product is safe and efficacious for its intended use, and to
define warnings, precautions and adverse reactions that are associated with such
product in the dosage range to be prescribed, and to support Regulatory Approval
of such product or label expansion of such Licensed Product, as described under
21 C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United
States, an equivalent clinical trial. In the event that a human clinical trial
that would otherwise meet the definition of a Phase 2 Clinical Trial would, if
the defined end-points are met, be sufficient to obtain Regulatory Approval in
the indication being studied then, for the purposes of this Agreement, such
trial shall be considered a Phase 3 Clinical Trial.

1.128.
“Phase 3b Clinical Trial” means, with respect to a Licensed Product for a given
indication in a given country or jurisdiction, a clinical trial of such Licensed
Product for such indication Initiated after submission of the MAA to the
applicable Governmental Authority for the sale

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of such product for such indication in such country or jurisdiction, but prior
to receipt of Regulatory Approval for the sale of such product for such
indication in such country or jurisdiction.
1.129.
“Phase 4 Clinical Trial” means, with respect to a Licensed Product for a given
indication in a given country or jurisdiction, a clinical trial of such Licensed
Product for such indication Initiated after receipt of Regulatory Approval for
the sale of such product for such indication in such country or jurisdiction.
Phase 4 Clinical Trials may include epidemiological studies, modeling and
pharmacoeconomic studies, and post-marketing surveillance studies, as well as
any clinical study or research study sponsored and conducted by an individual
not employed by or on behalf of either Party.

1.130.
“Pricing Approval” means, with respect to any country where a Governmental
Authority authorizes reimbursement, or approves or determines pricing, for
pharmaceutical products, receipt (or, if required to make such authorization,
approval or determination effective, publication) of such reimbursement
authorization or pricing approval or determination (as the case may be).

1.131.
“Prior Agreement” has the meaning set forth in Section 11.5 (Prior Agreement).

1.132.
“Quality Agreement” has the meaning set forth in Section 8.3 (Quality
Agreement).

1.133.
“RACI Documents” means, with respect to a given Licensed Product, the document
jointly developed and agreed in writing by the Parties on the Effective Date
setting forth certain operational responsibilities of each Party with respect to
Development, Manufacturing, Commercialization, Medical Affairs Activities and
other Product-related activities.

1.134.
“Recall” means a recall, market suspension or market withdrawal of a Licensed
Product or any lots thereof.

1.135.
“Recoveries” means all cash amounts (plus the fair market value of all non-cash
consideration) received by a Party from a Third Party in connection with the
final judgment, award or settlement of any enforcement with respect to any
Licensed Amgen Patent, Licensed Amgen Trademark, Licensed Amgen Know-How or
Joint Patent, each of the foregoing with respect to any Licensed Product in the
Field in the Territory.

1.136.
“Regulatory Approval” means, with respect to a given Licensed Product, the
product-specific approvals, licenses, permits, certifications, registrations or
authorizations from Governmental Authorities necessary under applicable Law for
the commercial distribution, Manufacture, marketing and sale of such Licensed
Product in a country or some or all of an extra-national territory.

1.137.
“Regulatory Filing” means, with respect to a given Licensed Product, any filing
with any Governmental Authority with respect to the Development or
Commercialization of such Licensed Product.

1.138.
“Royalty Term” means, with respect to a given Licensed Product, on a
country-by-country basis, that period from the First Commercial Sale of such
Licensed Product following Regulatory Approval in such country until the later
of: (i) the [*] anniversary of such First Commercial Sale; and (ii) the
expiration of the last to expire Valid Claim of a Licensed Amgen Patent which,
but for the licenses granted under this Agreement, would be infringed

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by the Development, registration, Manufacture, use, Commercialization, sale,
offer for sale or importation of such Licensed Product in such country.
1.139.
“[*]” means, collectively, [*].

1.140.
“Scientific Meeting” has the meaning set forth in Section 11.6.1.

1.141.
“Scientific Paper” has the meaning set forth in Section 11.6.2.

1.142.
“Segregate” means, with respect to two (2) programs: (i) to restrict and prevent
all program-related contacts and communications between personnel (whether
employees, consultants, Third Party contractors or otherwise and whether or not
located within the Territory (for purposes of this Section 1.142, and Section
7.3 (Post-Effective Date Affiliates) and Section 7.4 ([*] Divestiture),
“Personnel”)) working on or involved with the development or commercialization
of the first program and Personnel working on or involved with the development
or commercialization of the second program; (ii) to ensure that Personnel that
are working on the first program will not simultaneously work on the second
program and vice versa; (iii) to ensure that confidential information relating
to the first program is not shared with or accessed by Personnel that are
working on the second program and vice versa; and (iv) from time to time, upon
the reasonable request of the other Party, to provide information requested
relating to the foregoing items (i) through (iii), and to reasonably cooperate
to enable the other Party to verify that such restrictions are in place and
sufficient to achieve the foregoing. For clarity, the foregoing restrictions
will not prevent employees or consultants of each Party or its Affiliates that
are at or above the senior vice president level (or the equivalent) from
providing high-level oversight of both Collaboration and non-Collaboration
programs, provided that such employees do not have day-to-day responsibilities
for either program and that such Party ensures that such employees understand
and comply with their obligations of confidentiality and non-use as set forth
herein.

1.143.
“Senior Officers” means (i) for Development matters, the [*] for Novartis and
the [*] for Amgen (ii) for Medical Affairs Activities matters, the [*] for
Novartis and the [*] for Amgen; and (iii) for Commercialization matters, the [*]
for Novartis and the [*] for Amgen.

1.144.
“SPC” means any patent term extension or related extension of rights, including
supplementary protection certificates and similar rights.

1.145.
“Specified Studies” means, with respect to a Licensed Product, (i) all clinical
trials currently underway in the Territory for such Licensed Product in the
applicable Development Plan and (ii) all clinical trials in the applicable
Development Plan to be Initiated after the Effective Date which are global in
nature, including Phase 3b Clinical Trials.

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

1.146.
“Study Budget” means, with respect to a Study Plan, the aggregate budget of
Development Costs to conduct and complete the study contemplated by such Study
Plan, which shall specify the apportionment by Calendar Year.

1.147.
“Study Plan” means, with respect to a given Licensed Product, the plan for any
study agreed by the Parties to be included in the Development Plan for such
Licensed Product pursuant to Section 5.2.2 (Development Outside the Current
Development Plan) or Section 5.3 (Development Outside the Territory).

1.148.
“Supply Agreement” has the meaning set forth in Section 8.2 (Supply).

1.149.
“Taxes” means any tax, excise or duty, other than taxes upon income.

1.150.
“Term” means the period beginning on the Effective Date and ending upon the
termination of this Agreement pursuant to Section 7.3 (Termination or
Divestiture) or Article 15 (Term and Termination).

1.151.
“Territory” means the entire world, excluding the United States, Canada and
Japan.

1.152.
“Territory Brand Plan” means, with respect to a given Licensed Product, the
cross-functional Commercialization plan, including the go-to-market plan, as
updated from time to time, for such Licensed Product in the Territory in
accordance with the Global Brand Plan and approved by the JSC.

1.153.
“Territory Patents and Trademarks” has the meaning set forth in Section 10.2.1.1
(Amgen Primary Prosecution).

1.154.
“Third Party” means any entity other than a Party or an Affiliate of a Party.

1.155.
“Toxicology Report” means the final toxicology report, audited by the [*], for
Franchise Product 3.

1.156.
“Trademark” means any and all trademarks of every kind and nature, however
designated, whether arising by operation of law, contract, license or otherwise,
whether or not registered or unregistered, including product names, trade names,
service marks, logos, program names, taglines, slogans, trade dress, and any
other indicia of origin, including all related rights thereto such as copyrights
and design rights (including design patent rights) in pictures, logos, icons,
drawings and the like, and any similar and analogous rights anywhere worldwide
(excluding Housemarks).

1.157.
“Transition Period” has the meaning set forth in Section 15.5 (Transition
Period).

1.158.
“United States” or “U.S.” means the United States of America, including its
territories and possessions (including the District of Columbia and Puerto
Rico).

1.159.
“Valid Claim” means a claim of an issued and unexpired patent, which claim has
not been revoked or held invalid or unenforceable by a court or other government
agency of competent jurisdiction or has not been held or admitted to be invalid
or unenforceable through re-examination or disclaimer, reissue, opposition
procedure, nullity suit or otherwise.

1.160.
“VAT” means any value added tax.

2.
OPTION

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2.1.
Option for Franchise Product 3. Novartis shall have [*] right, exercisable
during the Option Period, to obtain the [*] licenses set forth in Section 4.1
(Licensed Amgen Patents and Know-How) and Section 4.5 (Trademarks), in each case
with respect to Franchise Product 3 (the “Option”). Novartis may exercise the
Option at any time during the Option Period by so notifying Amgen in writing
(the “Option Exercise Notice”) prior to the expiration of the Option Period. In
connection with the foregoing, as soon as reasonably practicable after the
Effective Date, the Parties shall discuss the plan and budget for Development,
in each case for Franchise Product 3, pursuant to Section 2.3 (Development Prior
to Option Exercise Date). Amgen shall, [*], prepare and deliver to Novartis
Option Data Package 1 (and thereafter during Option Period 1, [*] in Option Data
Package 1, [*]). In the event that Option Period 1 expires without Novartis
having exercised the Option in accordance with this Section 2.1 (Option for
Franchise Product 3), Amgen shall, promptly (but in any event within [*] days)
after [*], prepare and deliver to Novartis Option Data Package 2 (and thereafter
during Option Period 2, [*] in Option Data Package 2, [*]). For purposes of
clarity, (i) prior to the Option Exercise Date, Franchise Product 3 shall not be
a “Licensed Product” hereunder and (ii) from and after the Option Exercise Date,
Franchise Product 3 shall be included as a “Licensed Product” hereunder.
Notwithstanding anything to the contrary herein, prior to the Option Exercise
Date and, if the Option Period expires without Novartis having exercised the
Option in accordance with this Section 2.1 (Option for Franchise Product 3),
from and after such expiration of the Option Period, Novartis hereby covenants
not to sue or assert any claim or liability against Amgen or its Affiliates or
sublicensees under any Licensed Amgen Patent with respect to the Manufacture,
Development or Commercialization of, or conduct of Medical Affairs Activities
with respect to, Franchise Product 3 in or for the Territory. Promptly following
the Option Exercise Date, Amgen shall update the Licensed Amgen Patent Schedule
to include any Patents Controlled by Amgen or its Affiliates in the Territory
relating to Franchise Product 3. In furtherance of the foregoing, Amgen hereby
covenants and agrees that it shall not grant any licenses or rights (including,
without limitation, any Development, Medical Affairs Activities or
Commercialization rights) to any Third Party with respect to Franchise Product 3
during the Option Period.

2.2.
Effect of Option Period Expiration. If the Option Period expires without
Novartis having exercised the Option in accordance with Section 2.1 (Option for
Franchise Product 3), then, effective immediately and automatically upon such
expiration of the Option Period, and without any further action on the part of
either Party, (i) the Option shall terminate and be of no further force or
effect, (ii) the licenses granted in Article 4 (Grant of License) shall be
deemed null and void ab initio with respect to Franchise Product 3; (iii) Amgen
shall have no further obligation to Novartis with respect to Franchise Product 3
and Novartis shall have no further obligation to Amgen with respect to Franchise
Product 3; and (iv) this Agreement shall terminate in accordance with Section
15.2.1 (Termination with Respect to Franchise Product 3 if Option not Exercised
during Option Period) with respect to Franchise Product 3.

2.3.
Development Prior to Option Exercise Date. Prior to the Option Exercise Date,
subject to Section 7.3 (Post-Effective Date Affiliates), [*] for Development of
Franchise Product 3 and the Parties shall meet [*] in person, via teleconference
or videoconference or otherwise,

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or as otherwise agreed by the Parties, to discuss Development of Franchise
Product 3 globally and to develop an initial plan and budget for Development for
Franchise Product 3. Any in-person meetings shall be held on an alternating
basis between Novartis’s and Amgen’s facilities, unless otherwise agreed by the
Parties. Each Party shall be responsible for its own expenses relating to such
meetings. Amgen shall consider [*] expressed by Novartis with respect to such
Development, [*].

3.
COLLABORATION SCOPE AND GOVERNANCE

3.1.
Conduct of the Collaboration. The Parties shall cooperate to Develop the
Licensed Products worldwide, conduct Medical Affairs Activities with respect to
Licensed Products in the Field in the Territory, and Commercialize the Licensed
Products in the Field in the Territory, in each case in accordance with the
terms and conditions of this Agreement (the “Collaboration”).

3.2.
Committees and Teams.

3.2.1.
Promptly but not later than sixty (60) days following the Effective Date, the
Parties shall establish a cross-functional joint management committee (the
“Joint Management Committee” or “JMC”) to review the overall strategy of the
Collaboration and, as needed, attempt to resolve issues presented to it by, and
disputes within, the Joint Steering Committee, in accordance with Section 3.5
(Decision Making).

3.2.2.
Promptly but not later than sixty (60) days following the Effective Date, the
Parties shall establish a cross-functional joint steering committee (the “Joint
Steering Committee” or “JSC”) to upon such formation, with respect to Franchise
Product 1 and Franchise Product 2, and from and after the Option Exercise Date,
with respect to Franchise Product 3, (i) review strategies for Manufacture of
such Licensed Product for and in the Territory and review and approve plans and
strategies for, and the conduct and progress of, activities by each Party
relating to the Development worldwide and Medical Affairs Activities and
Commercialization in the Territory of such Licensed Product, including the
applicable Development Plan, Global Brand Plan and Territory Brand Plan, (ii)
monitor the Parties’ activities under this Agreement pursuant to the applicable
Development Plan, Territory Brand Plan and Global Brand Plan, (iii) review and
annually approve the applicable Development Budget no later than [*] of each
Calendar Year, (iv) direct and oversee any JPT established by the JSC, on all
significant issues that fall within the responsibilities of such JPTs, (v)
attempt to resolve issues presented to it by, and disputes within, the JPTs, in
accordance with Section 3.5 (Decision Making), (vi) review and approve the RACI
Documents and any updates thereto, as needed, and (vii) make such determinations
as are expressly delegated to it under the terms of this Agreement. In
accordance with Section 3.4.1, each Party shall keep the Joint Steering
Committee informed of the progress and results of its activities under the
Development Plan, Territory Brand Plan, Global Brand Plan and RACI Documents
through its members on the Joint Steering Committee and as otherwise provided
herein. Amgen shall

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prepare the first draft of each Global Brand Plan, and Novartis shall prepare
the first draft of each Territory Brand Plan, in each case for presentation to
the JPT.
3.2.3.
Each of the Joint Steering Committee and the Joint Management Committee (each, a
“Committee”) will have solely the roles and responsibilities assigned to it in
this Article 3 (Collaboration Scope and Governance) and as otherwise expressly
set forth in this Agreement. Neither the Committees nor a Party exercising its
final decision making pursuant to Section 3.5 (Decision Making) will have
authority to amend, modify or waive compliance with this Agreement, to make
decisions that conflict with the terms and conditions of this Agreement, or to
create new financial or other obligations for a Party not specified in this
Agreement.

3.2.4.
Each Committee shall be comprised of an equal number of representatives from
each of Amgen and Novartis. The number of such representatives shall be, with
respect to the JSC, up to [*] for each of Amgen and Novartis, and with respect
to the JMC, up to [*] for each of Amgen and Novartis, or for each Committee such
other number as the Parties may agree in writing. The JSC and JMC shall be
composed of members of relevant functional specialties and expertise. The
members of each Committee shall have the appropriate level of seniority,
decision-making authority and expertise commensurate with the responsibilities
of the Committee to which they are appointed. The Alliance Managers appointed by
Amgen and Novartis pursuant to Section 3.7 (Alliance Managers) are ex officio
members of the JSC and JMC. Either Party may replace its respective committee
representatives at any time upon prior written notice to the other Party. In the
event a Committee member from either Party is unable to attend or participate in
a Committee meeting, the Party who designated such representative may designate
a substitute representative for the meeting in its sole discretion, the identity
of whom shall be communicated in advance to the other Party, in which case no
specific notice shall be required. In the event both the Committee member and
its substitute representative are unable to attend or participate in a Committee
meeting, the Party who designated such representatives may designate an ad hoc
representative for the meeting in its sole discretion, with prior notice to the
relevant Committee.

3.2.5.
Joint Project Teams. From time to time, the Joint Steering Committee or the
Parties may establish permanent or ad hoc cross-functional or function-specific
joint project teams to oversee particular projects or activities, including
Development, Manufacturing, Medical Affairs Activities and Commercialization,
within the scope of the JSC’s authority hereunder, and such joint project teams
will be constituted as the Joint Steering Committee approves (each, a “Joint
Project Team” or “JPT”). If any JPT is unable to reach a decision on any matter
after endeavoring in good faith to do so, such matter shall be referred to the
Joint Steering Committee for resolution as provided in Section 3.5 (Decision
Making).

3.3.
Committee Co-Chairs. Each Party shall appoint one of its members in each
Committee to co-chair such Committee’s meetings (each, a “Co-Chair”). The
Co-Chairs shall (i) ensure the orderly conduct of the Committee’s meetings, (ii)
attend each Committee meeting (either in-person, by videoconference or
telephonically), and (iii) ensure the preparation and

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issuance of written minutes of each meeting within [*] days thereafter
accurately reflecting the discussions and decisions of such meeting. Unless
otherwise agreed, the Committee shall have at least one (1) representative with
relevant decision-making authority from each Party such that the Committee is
able to effectuate all of its decisions within the scope of its
responsibilities. In the event the Co-Chair from either Party is unable to
attend or participate in a Committee meeting, the Party who designated such
Co-Chair may designate a substitute Co-Chair for the meeting in its sole
discretion.

3.4.
Committee Meetings.

3.4.1.
The Joint Steering Committee shall meet [*], or more or less often as otherwise
agreed by the Parties, but in no event less than [*] and such meetings may be
conducted by telephone, videoconference or in person as determined by the
Co-Chairs. As appropriate, and provided that not less than two (2) Business
Days’ prior written notice has been given to the other Party, other employees of
the Parties may attend Joint Steering Committee meetings as observers, but a
Party shall not bring a Third Party to a meeting without the other Party’s prior
consent. Either Party may also call for special meetings of the Joint Steering
Committee (in person, by videoconference or teleconference) with reasonable
prior written notice (it being agreed that at least [*] Business Days shall
constitute reasonable notice) to resolve particular matters requested by such
Party and within the decision-making responsibility of the Joint Steering
Committee. Each Co-Chair shall ensure that its Joint Steering Committee members
receive adequate notice of such meetings.

3.4.2.
The Joint Management Committee shall meet [*], or more or less often as
otherwise agreed by the Parties, and such meetings may be conducted by
telephone, videoconference or in person as determined by the Co-Chairs. As
appropriate, provided that not less than two (2) Business Days’ prior written
notice has been given to the other Party, and subject to such other Party’s
approval (not to be unreasonably withheld, conditioned or delayed), other
employees of the Parties may attend Joint Management Committee meetings as
observers. Either Party may also call a special meeting of a Joint Management
Committee (in person, by videoconference or teleconference) by at least [*]
Business Days’ prior written notice to the other Party in the event such Party
reasonably believes that a significant matter must be addressed prior to the
next regularly scheduled meeting, and such Party shall provide the Joint
Management Committee no later than [*] Business Days prior to the special
meeting with materials reasonably adequate to enable an informed decision.

3.5.
Decision Making. Other than as set forth herein, in order to make any decision
required of it hereunder, the Joint Steering Committee and the Joint Management
Committee must have present (in person, by videoconference or telephonically) at
least the Co-Chair of each Party (or his/her designee for such meeting). The
Parties will endeavor to make decisions where required of the Joint Steering
Committee and the Joint Management Committee by mutual agreement of the
Co-Chairs. The Parties will endeavor to make decisions within a Joint Project
Team by mutual agreement. If a dispute arises which cannot be resolved within a
Joint Project Team, the Co-Chairs of either Party may cause such dispute to be
referred to the Joint Steering Committee for resolution. If a dispute arises on
a Critical Matter which

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cannot be resolved within the Joint Steering Committee, the Co-Chair of either
Party may cause such dispute to be referred to the Joint Management Committee
for resolution; provided that if, in the good faith determination of the
Co-Chair with the deciding vote at the JMC, resolution of such matter requires
[*] pursuant to applicable Law or to prevent a material adverse effect on a
Licensed Product or a Party, such Co-Chair will have the right to make an
interim decision pending JMC determination. Within the Joint Steering Committee
(for non-Critical Matters) and the Joint Management Committee (for Critical
Matters):
3.5.1.
Development:

3.5.1.1.
Prior to [*], the Amgen Co-Chair shall have the deciding vote on all Development
and Medical Affairs Activities matters for all Licensed Products whether within
or outside the Territory.

3.5.1.2.
Following [*], (i) the Amgen Co-Chair shall have the deciding vote on all
Development and Medical Affairs Activities matters for all Licensed Products
outside the Territory and (ii) the Novartis Co-Chair shall have the deciding
vote on all Development and Medical Affairs Activities matters for all Licensed
Products in the Territory unless, in either case, (a) [*] with respect to, any
Licensed Product [*] or (b) [*] with respect to, any Licensed Product [*], in
which case ((a) and (b)), [*].

3.5.2.
Regulatory: The Amgen Co-Chair shall have the deciding vote on all regulatory
matters for all Licensed Products outside the Territory and the Novartis
Co-Chair shall have the deciding vote on all regulatory matters for all Licensed
Products in the Territory unless, in either case, (a) [*] any Licensed Product
[*] or (b) [*] any Licensed Product [*], in which case ((a) and (b)), [*].

3.5.3.
Commercialization.

3.5.3.1.
The Amgen Co-Chair shall have the deciding vote with respect to the Global Brand
Plans and all Commercialization matters with respect to the Licensed Products
outside the Territory.

3.5.3.2.
The Novartis Co-Chair shall have the deciding vote with respect to the Territory
Brand Plans and all Commercialization matters with respect to the Licensed
Products within the Territory; provided that such activities must be consistent
with the applicable Territory Brand Plan, and [*] must [*].

3.5.4.
Escalation of Critical Matters. If either Party believes its comments as to any
Critical Matter are not being given adequate consideration at the JMC, then such
Party may request that such matter be reviewed and discussed by a Senior Officer
of each Party who is not a JMC member prior to final decision by the JMC.
Escalation of a matter to such Senior Officers shall suspend implementation of
any decision of the JMC on such matter until completion of such escalation
process or earlier resolution of the matter by the JMC; provided that if, in the
good faith determination of the Co-Chair with the deciding vote at the JMC,
resolution of such matter requires [*] pursuant to applicable Law or to prevent
a material adverse effect on a Licensed

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Product or a Party, such Co-Chair will have the right to make an interim
decision pending JMC determination.

3.6.
Interactions Between the Joint Management Committee, the Joint Steering
Committee, and Joint Project Teams. The Parties recognize that while they will
establish the Joint Management Committee, the Joint Steering Committee and Joint
Project Teams for the purposes hereof, each Party maintains internal structures
(including its own committees, teams and review boards) that will be involved in
administering such Party’s activities under this Agreement. The Parties shall
establish procedures to facilitate communications between the Joint Management
Committee, the Joint Steering Committee and Joint Project Teams hereunder and
the relevant internal committees, teams or boards within each Party in order to
maximize the efficiency of the Parties’ activities pursuant to this Agreement.

3.7.
Alliance Managers. Promptly but not later than sixty (60) days following the
Effective Date, each of Amgen and Novartis shall appoint one or more senior
representatives who possess a general understanding of Development, regulatory,
Medical Affairs Activities, Manufacturing and Commercialization matters to act
as its respective alliance manager(s) for the Collaboration (each, an “Alliance
Manager”). Each Party may replace its respective Alliance Manager(s) at any time
upon written notice to the other in accordance with this Agreement. Any Alliance
Manager may designate a substitute to temporarily perform the functions of that
Alliance Manager. Each Alliance Manager shall be charged with creating and
maintaining a collaborative work environment within and among the Committees.
Consistent with the Development Plan, the Territory Brand Plan and Section 3.5
(Decision Making), each Alliance Manager, on behalf of the applicable Party’s
Co-Chair of the applicable Committee, will also be responsible for:

3.7.1.
providing a single point of communication for seeking consensus both within the
respective Party’s organization and together regarding key strategy and plan
issues;

3.7.2.
identifying and raising disputes to the JSC or JMC for discussion in a timely
manner; and

3.7.3.
planning and coordinating internal and external communications in accordance
with the terms of this Agreement.

The Alliance Managers shall be entitled to attend all JSC and JMC meetings, and
shall have the right to attend all JPT meetings. Consistent with Section 3.5
(Decision Making), each Alliance Manager may bring any matter to the attention
of the JSC or JMC where such Alliance Manager reasonably believes that such
matter requires attention of the JSC or JMC.

3.8.
Outside the Territory. Unless expressly set forth in this Agreement otherwise,
Amgen shall have sole decision-making authority with regard to Development,
regulatory, Medical Affairs Activities, Manufacturing and Commercialization of
Licensed Products outside the Territory. Novartis and its Affiliates shall not
Commercialize or conduct Medical Affairs Activities with respect to Licensed
Products in any country outside the Territory.

4.
GRANT OF LICENSE

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4.1.
Licensed Amgen Patents and Know-How. Amgen hereby grants to Novartis, during the
Term, effective as of the Effective Date, with respect to Franchise Product 1
and Franchise Product 2, and effective as of the Option Exercise Date, with
respect to Franchise Product 3 (without any further action by either Party),
subject to the terms and conditions hereof, (i) [*] ([*]), royalty-bearing right
and license under the Licensed Amgen Patents, Licensed Amgen Know-How and
Amgen’s interest in the Joint Patents, solely to use, research, Develop, conduct
Medical Affairs Activities with respect to, sell, import and otherwise
Commercialize the Licensed Products in the Field in the Territory in accordance
with this Agreement; and (ii) [*], royalty-bearing right and license under the
Licensed Amgen Patents, Licensed Amgen Know-How and Amgen’s interest in the
Joint Patents, solely to Develop the Licensed Products outside of the Territory
in support of the Development or Commercialization of Licensed Products in the
Field in the Territory subject to Section 5.3 (Development Outside the
Territory). Such license shall include the right to sublicense only as set forth
in Section 4.3 (Sublicensing) and shall be subject to Amgen’s right to conduct
(itself or through its Affiliates or contractors) Development of Licensed
Products in the Territory in accordance with this Agreement.

4.2.
Licensed Novartis Know-How and Patents. Novartis hereby grants to Amgen,
effective as of the Effective Date, with respect to Franchise Product 1 and
Franchise Product 2, and effective as of the Option Exercise Date, with respect
to Franchise Product 3 (without any further action by either Party), subject to
the terms and conditions hereof (including Section 15.3.2 (Termination
Effects)), [*], fully-paid, royalty-free, perpetual right and license, under the
Licensed Novartis Know-How and Licensed Novartis Patents solely to Manufacture,
research, Develop, conduct Medical Affairs Activities with respect to, use,
sell, import and otherwise Commercialize, the Licensed Products in the Field
outside the Territory (and worldwide after termination of this Agreement), and
within and outside the Territory for Manufacturing and for performing its
obligations hereunder, including any supply obligations with respect to the
Licensed Products. Such license shall include the right to sublicense only as
set forth in Section 4.3 (Sublicensing).

4.3.
Sublicensing. Each Party shall have the right to sublicense the rights granted
to such Party hereunder, subject to the terms and conditions of this Section 4.3
(Sublicensing). Novartis shall have the right to sublicense the rights granted
it hereunder (i) as mutually agreed by the Parties, (ii) to contractors (e.g.,
contract research organizations, distributors, wholesalers, contract sales
forces) in the Territory provided that Novartis remains primarily responsible
for the activities of any such contractors, (iii) in connection with
country-specific (i.e., not international or multi-national) co-marketing
arrangements and (iv) to country-specific (i.e., not international or
multi-national) distributors; provided that any sublicense under the foregoing
clause (iii) or (iv) shall be subject to Amgen’s consent, not to be unreasonably
withheld, solely in the event that the marketing authorization for the
applicable Licensed Product in the applicable country will be transferred to
such sublicensee. Amgen shall have the right to sublicense the rights granted it
hereunder (i) as mutually agreed by the Parties and (ii) to those parties to
which Amgen (or its Affiliate or licensee) is also granting licenses to Amgen
patents or know-how relating to the applicable Licensed Product(s) or the use
thereof (other than a global sublicense of all rights to Develop the applicable
Licensed Product(s)). The Party granting the sublicense hereunder will remain
responsible for the full

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and complete performance of all of such Party’s obligations and duties under
this Agreement and compliance of any such Third Party and sublicense with the
terms of this Agreement. Each Party shall promptly notify the other Party of the
grant of each sublicense (other than a sublicense with a contractor). Novartis
shall provide Amgen a copy of the final executed sublicense agreement, redacted
for information not pertinent to this Agreement (including financial terms). Any
such sublicense agreement shall obligate the sublicensee to comply with all
relevant restrictions, limitations and obligations in this Agreement including
those relating to confidentiality of the other Party’s Confidential Information.
Any use by a Party of a Third Party (including contractors) to perform
obligations under this Agreement shall be pursuant to a written agreement that
is materially as protective of the other Party and its intellectual property and
proprietary rights as the terms of this Agreement.

4.4.
Provision of Know-How. Following the Effective Date, with respect to Franchise
Product 1 and Franchise Product 2, and following the Option Exercise Date, with
respect to Franchise Product 3, the Parties shall cooperate to establish
procedures for the provision of Licensed Amgen Know-How relating to the
applicable Licensed Product to Novartis and Licensed Novartis Know-How relating
to the applicable Licensed Product to Amgen, in each case to the extent [*] for
such Party to exercise its rights and perform its obligations in accordance with
this Agreement. From and after the Effective Date, with respect to Franchise
Product 1 and Franchise Product 2, and from and after the Option Exercise Date,
with respect to Franchise Product 3, during the Term, Amgen shall use [*] to
provide all Licensed Amgen Know-How related to the applicable Licensed Product
to Novartis, and Novartis shall use [*] to provide all Licensed Novartis
Know-How related to the applicable Licensed Product to Amgen, in each case to
the extent [*] to exercise its rights and perform its obligations in accordance
with this Agreement. In any event, following the Effective Date, with respect to
Franchise Product 1 and Franchise Product 2, and following the Option Exercise
Date, with respect to Franchise Product 3, each of the Parties shall provide to
the other any Licensed Amgen Know-How or Licensed Novartis Know-How related to
the applicable Licensed Product (respectively) as the other Party shall
reasonably request; provided that a Party shall not be obligated to disclose any
Licensed Amgen Know-How or Licensed Novartis Know-How, as the case may be, that
is (i) proprietary or trade secret with respect to such Party and (ii) not [*]
for the other Party to exercise its rights and perform its obligations in
accordance with this Agreement. Unless otherwise agreed by the Parties,
information shared under this Section 4.4 (Provision of Know-How) shall be
disclosed in the English language.

4.5.
Trademarks.

4.5.1.
Grant to Novartis. Amgen hereby grants to Novartis, effective as of the
Effective Date, with respect to Franchise Product 1 and Franchise Product 2, and
effective as of the Option Exercise Date, with respect to Franchise Product 3
(without any further action by either Party), [*] (except as otherwise expressly
set forth herein (such exception to include the transition period described in
Section 15.5 (Transition Period))) right and license during the Term, subject to
the terms and conditions hereof, solely to research, Develop, conduct Medical
Affairs Activities with respect to, use, sell, import and otherwise
Commercialize the applicable Licensed Product in the Field in the Territory
under the same Licensed Amgen Trademarks as used by Amgen, its Affiliates or
permitted licensees or sublicensees for such Licensed

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Product in the corresponding indications outside the Territory. In the event
that Amgen has identified a Licensed Amgen Trademark to be so used, and is
developing plans to so use such Licensed Amgen Trademark, the foregoing license
shall permit Novartis to similarly conduct such planning activities in the
Territory to the same extent of Amgen’s planning activities outside the
Territory. Each Party shall provide regular updates to the other Party regarding
proposed Licensed Amgen Trademarks and Licensed Novartis Trademarks, as the case
may be. Such license shall include the right to sublicense only as set forth in
Section 4.3 (Sublicensing). Should Novartis desire that a different trademark be
used for a given Licensed Product in the Field in the Territory, or if
additional trademarks to those used outside the Territory are otherwise
required, Novartis shall be entitled to do so after consulting with Amgen and
giving due consideration to Amgen’s reasonable comments regarding an additional
or replacement trademark (or trademarks). Such replacement or additional
trademark(s) shall be registered and owned by Novartis in the Territory. At
Amgen’s election and with the approval of the applicable Governmental Authority,
the labeling, packaging and materials for any Licensed Product supplied by or on
behalf of Amgen to Novartis hereunder shall include Amgen Housemarks in equal
prominence with Novartis Housemarks, provided that Amgen shall inform Novartis
sufficiently in advance of making such election.

4.6.
Trademark and Housemark Quality Standards. Each Party shall (i) maintain such
reasonable quality standards for the Amgen Housemarks and Licensed Amgen
Trademarks (with respect to Novartis) or the Novartis Housemarks and Licensed
Novartis Trademarks (with respect to Amgen) as it maintains for its own
trademarks of a similar nature and shall comply with the other Party’s
reasonable specifications and usage standards supplied to it in writing (and as
may be updated by written notice from time to time); (ii) not use any Amgen
Housemark or Licensed Amgen Trademark (with respect to Novartis) or any Novartis
Housemark or Licensed Novartis Trademark (with respect to Amgen) in a manner
that suggests any connection with any product or service, other than use
associated with the applicable Licensed Product or any service associated with
such Licensed Product; and (iii) not use or display the Amgen Housemarks or
Licensed Amgen Trademarks (with respect to Novartis) or the Novartis Housemarks
or Licensed Novartis Trademarks (with respect to Amgen) in any manner that might
dilute, tarnish, disparage or reflect adversely on the other Party or such
marks. Prior to using any Amgen Housemark or Licensed Amgen Trademark (with
respect to Novartis) or Novartis Housemark or Licensed Novartis Trademark (with
respect to Amgen), the Parties shall agree upon a guideline for use of such
trademarks, including the review procedure and timing. From time to time, upon
request by a Party, the other Party shall provide copies of the usage of the
Amgen Housemarks and Licensed Amgen Trademarks (with respect to Novartis) or
Novartis Housemarks and Licensed Novartis Trademarks (with respect to Amgen)
used in the marketing or promotion of the applicable Licensed Product in order
to review such usage. Amgen agrees that it shall not seek to register or obtain
ownership rights in any Novartis Housemark or Licensed Novartis Trademark (or
confusingly similar trademark) and Novartis agrees that it shall not seek to
register or obtain ownership rights in any Amgen Housemark or Licensed Amgen
Trademark

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

or any trademark used by Amgen in connection with the applicable Licensed
Product outside the Territory in any indication (or confusingly similar
trademark to any of the foregoing).

4.7.
Domain Names. Amgen shall be [*] entitled to register, own and use any Domain
Names corresponding to or containing Amgen Housemarks or Amgen Licensed
Trademarks in any generic Top Level Domains (gTLDs), including the new and to be
introduced gTLDs. Amgen shall own all goodwill associated with all Domain Names
corresponding to or containing an Amgen Housemark or Amgen Licensed Trademark
throughout the world. Novartis shall be [*] entitled to register, own and use
any Domain Names corresponding to or containing a Licensed Amgen Trademark in
any Country Code Top Level Domains (ccTLDs) corresponding to countries within
the Territory.

4.8.
Retained Rights and Limitations. No rights to either Party’s patents, trademarks
or other proprietary rights are granted pursuant to this Agreement except as
expressly set forth herein, and all other rights are reserved. Subject to
Section 2.3 (Development Prior to Option Exercise Date), Novartis shall not
research, Develop, Manufacture, conduct Medical Affairs Activities with respect
to or Commercialize Franchise Product 3 prior to the Option Exercise Date or any
Licensed Product outside the Territory and Amgen shall not research, Develop,
conduct Medical Affairs Activities with respect to or Commercialize any Licensed
Product inside the Territory, in each case, other than as expressly set forth in
this Agreement (including under a Development Plan). Notwithstanding the
licenses granted in this Article 4 (Grant of License), each Party retains rights
to perform (itself or through its Affiliates or contractors) its obligations
under this Agreement.

5.
DEVELOPMENT AND REGULATORY

5.1.
Responsibility for Development. Except as otherwise set forth in this Section
5.1 (Responsibility for Development), from and after the Effective Date, with
respect to Franchise Product 1 and Franchise Product 2, and from and after
Option Exercise Date, with respect to Franchise Product 3, the Parties will
share responsibility for day-to-day Development activities for each Licensed
Product worldwide in accordance with the applicable Development Plan and
Development Budget, including generating protocols subject to the JSC’s review
and approval, conducting clinical trials, and data collection, verification and
analysis. Solely with respect to Franchise Product 1 prior to receipt of the
first Regulatory Approval therefor in the U.S., (i) Amgen shall be the
Development lead and shall have primary responsibility for day-to-day
Development activities relating thereto worldwide in accordance with the
applicable Development Plan and Development Budget and (ii) Novartis shall
provide both strategic input and operational support for such activities as
agreed in the applicable Development Plan and Development Budget; provided that,
notwithstanding the foregoing, Novartis shall have those responsibilities with
respect to Franchise Product 1 and Franchise Product 2 as set forth in the RACI
Documents, including with respect to [*]. In the event of a conflict between the
terms of this Agreement, a Supply Agreement or a Quality Agreement, on the one
hand, and the RACI Documents, on the other hand, the terms of this Agreement,
such Supply Agreement or such Quality Agreement shall prevail. Additionally, [*]
shall be [*] responsible for the development of any Clinical Trials or other
activities directed to Lifecycle Management for the Licensed Products as agreed

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

by the JSC and approved by the JMC. [*] shall be responsible at its expense for
determining and providing all Medical Affairs Activities relating to the
Licensed Products in the Territory.

5.2.
Development Within and Outside Development Plan.

5.2.1.
Development Plan. From and after the Effective Date, with respect to Franchise
Product 1 and Franchise Product 2, and from and after the Option Exercise Date,
with respect to Franchise Product 3, the Parties shall conduct Development of
Licensed Products in accordance with the Development Plan and Development
Budget. The JSC shall review the Development Plan and Development Budget,
including the Study Plans and Study Budgets, at least annually and, if agreed,
the Parties shall approve revisions to such plans and budgets.

5.2.2.
Development Outside the Current Development Plan. In the event that either Party
or any of its Affiliates or sublicensee(s) desires to conduct a clinical study
with respect to Licensed Product(s) not included in the then-current Development
Plan, then such Party shall provide written notice to the JSC of the proposed
trial design (including the most current protocol draft), study size (estimated
number of patients), study site and any identified investigators (including
names, qualifications and professional positions), and the purpose of such
study. If the other Party so agrees, such study will be included in the
Development Plan and the Parties shall agree upon a Study Budget therefor. If
the other Party does not wish to include such study in the Development Plan,
[*], the Party proposing the study [*]. In any event, [*].

5.2.3.
Non-Clinical Studies. Either Party may propose to the JSC additional
non-clinical studies or other Development-related activities for Licensed
Product(s) in the Territory not included in the then-current Development Plan,
and the JSC shall consider appropriate participation and cost sharing between
the Parties with respect to such activities.

5.3.
Development Outside the Territory by Novartis or Inside the Territory by Amgen.
In the event that in furtherance of the Development activities for Licensed
Product(s) in the Territory (in the case of Novartis) or outside the Territory
(in the case of Amgen), a Party or any of its sublicensee(s) believes it needs
to conduct clinical studies outside the Territory (in the case of Novartis) or
within the Territory to the extent not included in a Development Plan (in the
case of Amgen) for such purpose, then such Party shall provide written notice to
the JSC of the proposed trial design (including the most current protocol
draft), study size (estimated number of patients), study site, investigators
(including names, qualifications and professional positions) and the purpose of
and need for such study. Such Party shall not conduct such studies outside the
Territory (in the case of Novartis) or within the Territory (in the case of
Amgen) without the other Party’s prior written consent, such consent not to be
unreasonably withheld, conditioned or delayed (it being understood that not
providing consent shall be deemed reasonable in the event such other Party is in
active enrollment for a clinical trial at such study site or if such proposed
clinical study would reasonably be expected to adversely impact recruitment for
any clinical trial of such other Party). If the other Party grants consent and
so agrees, such studies will be included in the Development Plan and the
Development Budget. If the other Party does not wish to include such studies in
the Development Plan, the proposing Party shall [*].

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

5.4.
Regulatory Matters.

5.4.1.
Regulatory Communications and Filings. Amgen shall be the regulatory lead
outside the Territory and shall have responsibility for regulatory activities
relating to the Licensed Products outside the Territory, including preparing,
submitting and maintaining all Regulatory Filings outside the Territory in
accordance with the Development Plan, and Novartis shall provide strategic input
for such activities therefor as set forth in the Development Plan. Subject to
this Section 5.4.1 (Regulatory Communications and Filings), Novartis shall be
the regulatory lead in the Territory and shall have primary responsibility for
regulatory activities relating to the Licensed Products in the Territory,
including preparing, submitting and maintaining all Regulatory Filings in the
Territory in accordance with the Development Plan, and Amgen shall provide
strategic input for such activities therefor as set forth in the Development
Plan; [*]. Notwithstanding the foregoing or Section 3.5.2 (Regulatory), the
Parties shall mutually agree on the timing of the filing strategy for marketing
applications for each Licensed Product to be consistent with Amgen’s drug
Manufacturing plans applicable to Licensed Product to be supplied for the
Territory. Unless [*] is required with respect to such Regulatory Filing or a
material communication with a Governmental Authority with respect to any
Licensed Product, the lead regulatory Party shall provide the other Party with
copies of material Regulatory Filings (which, for clarity, shall not be required
to include communications that are solely administrative in nature) prior to
submission within a reasonable amount of time and reasonably consider comments
of such other Party (but in the event of a disagreement between the Parties with
respect to such comments and proposed revisions, such matter shall be escalated
to the JSC for review). The lead regulatory Party shall consult with the other
Party regarding, and keep such other Party informed of, the status of the
preparation of all Regulatory Filings (which, for clarity, shall not be required
to include communications that are solely administrative in nature) it submits,
Governmental Authority review of any such Regulatory Filings, and all Regulatory
Approvals that it obtains with respect to the Licensed Products. The lead
regulatory Party shall provide to the other Party copies of all final Regulatory
Filings it submits promptly after the submission (but in no event later than [*]
days after submission). Through the JPT, the Parties shall agree to the point at
which Novartis shall take the lead regulatory role in the Territory for purposes
of performing Territory-specific clinical trials and supporting pricing and
reimbursement in the Territory, with the intent of not interrupting Amgen’s
regulatory activities with respect to the Licensed Products, providing Novartis
with sufficient lead-time to conduct interactions with Governmental Authorities
in connection with any [*] for such Licensed Product in the Territory and to
hold pre-MAA meetings with the EMA and file the MAAs for the Licensed Products
in the Territory, and to effect a smooth and efficient transfer (which shall
occur no later than promptly following [*] in the U.S. for the applicable
Licensed Product).

5.4.2.
Regulatory Meetings. The lead regulatory Party shall consult with the other
Party reasonably in advance of the date of any anticipated meeting with a
Governmental Authority in the Territory and shall consider any timely
recommendations made by

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

such other Party in preparation for such meeting. A representative of Amgen [*]
scheduled meetings between Novartis and the applicable Governmental Authority in
the Territory with respect to any Licensed Product, to the extent permissible by
such Governmental Authority. Novartis shall inform Amgen of any unscheduled
teleconferences and meetings (other than teleconferences and meetings that are
solely administrative in nature) with Governmental Authorities in the Territory
with respect to the Licensed Product reasonably promptly after they occur. A
representative of Novartis [*] scheduled meetings between Amgen and the
applicable Governmental Authority outside the Territory with respect to any
Licensed Product, to the extent permissible by such Governmental Authority. [*]
5.4.3.
Ownership of Regulatory Filings and Regulatory Approvals. Consistent with the
transfer of the lead regulatory role in the Territory described in Section 5.4.1
(Regulatory Communications and Filings), Amgen shall transfer to Novartis all
prior Regulatory Filings in the Territory in Amgen’s possession with respect to
each Licensed Product. Novartis shall not transfer title in, fail to maintain or
otherwise attempt in any manner to dispose of any Regulatory Filings or
Regulatory Approvals or other governmental licenses, approvals or certificates
for the Licensed Products in the Territory without the prior written approval of
Amgen.

5.4.1.
Clinical Trial Data. Right of Reference.

5.4.1.1.
From and after the Effective Date, with respect to Franchise Product 1 and
Franchise Product 2, and from and after the Option Exercise Date, with respect
to Franchise Product 3, (i) Novartis shall maintain a database containing all
clinical trial data accumulated from all clinical trials of the applicable
Licensed Product conducted by, on behalf of, or with the support of Novartis in
the Territory or outside the Territory if Amgen agrees ([*]), and (ii) Amgen
shall maintain a database containing all clinical trial data accumulated from
all clinical trials of the applicable Licensed Product conducted by, on behalf
of, or with the support of Amgen outside the Territory or in the Territory
([*]). Each Party shall require that, with respect to any clinical trial
conducted pursuant to the Development Plan, study investigators obtain patient
authorizations and consents required under the United States Health Insurance
Portability and Accountability Act of 1996, the EU Data Protection Directive or
any other similar applicable Law in connection with such clinical trial to
permit the sharing of clinical data from such clinical trial with the other
Party.

5.4.1.2.
From and after the Effective Date, with respect to Franchise Product 1 and
Franchise Product 2, and from and after Option Exercise Date, with respect to
Franchise Product 3, upon the request of either Party, the other Party shall
provide a right of reference to any requested Regulatory Filings or Regulatory
Approvals for each Licensed Product (provided that Novartis shall not grant a
right of reference to Novartis [*] Data and any Regulatory Filings or Regulatory
Approvals referring to Novartis [*] Data, and Amgen shall not grant a right of
reference to Amgen [*] Data and any Regulatory Filings or

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Regulatory Approvals referring to Amgen [*] Data), in each case as [*] for the
requesting Party’s Development, Manufacture (in the case of Amgen only), conduct
of Medical Affairs Activities with respect to, or Commercialization of the
applicable Licensed Product as permitted hereunder. Each Party shall be entitled
to sublicense such right to any permitted licensee pursuant to Section 4.3
(Sublicensing).

5.5.
Safety Matters.

5.5.1.
Safety Agreement. Promptly following the Effective Date, with respect to
Franchise Product 1 and Franchise Product 2, and promptly following the Option
Exercise Date, with respect to Franchise Product 3, Amgen and Novartis shall
develop and agree upon safety data exchange procedures governing the
coordination of collection, investigation, reporting, and exchange of
information concerning adverse events with respect to the applicable Licensed
Product sufficient to permit each Party, its Affiliates, permitted sublicensees
and licensees to comply with Law, including, to the extent applicable, those
obligations contained in FDA and EMA regulations. Details of the operating
procedure respecting such adverse event reports and safety information exchange
shall be the subject of a mutually-agreed written pharmacovigilance agreement
between the Parties which shall be entered into within ninety (90) days of the
Effective Date (or any other longer period as may be agreed between the
Parties).

5.5.2.
Adverse Event Reporting. From and after the Effective Date, with respect to
Franchise Product 1 and Franchise Product 2, and from and after the Option
Exercise Date, with respect to Franchise Product 3, each Party shall (i) be
responsible for reporting to the relevant Governmental Authorities all adverse
events with respect to the Licensed Products (whether within or outside the
Territory), to the extent required by and in accordance with Law; (ii) ensure
that its Affiliates, permitted sublicensees and licensees, as applicable, comply
with all such reporting obligations; and (iii) designate a safety liaison to be
responsible for communicating with the other Party regarding the reporting of
adverse events with respect to the Licensed Products.

5.5.3.
Ownership of Core Data Sheet and Global Safety Database. As between the Parties,
Amgen shall own and control the global safety database, the Developmental core
safety information (“DCSI”), and core data sheet for each Licensed Product
throughout each Licensed Product’s lifecycle, including Commercialization. Amgen
shall provide to Novartis copies of such DCSI and core data sheet and any
updates thereto in a timely manner (such that Novartis has a current version of
such files), shall provide Novartis the opportunity to review and provide
comments on the core data sheet, and shall reasonably consider such comments of
Novartis in good faith. In the event that a Governmental Authority in the
Territory mandates a change to a regional or country-specific label for a
Licensed Product that varies from the applicable core data sheet, Novartis shall
notify Amgen and Amgen shall permit such mandated variance from such core data
sheet.

5.6.
Cooperation Generally. From and after the Effective Date, with respect to
Franchise Product 1 and Franchise Product 2, and from and after the Option
Exercise Date, with respect to

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Franchise Product 3, subject to the oversight of the JSC, the Parties shall
provide each other with any cooperation reasonably requested by the other with
respect to the Development of and Regulatory Approval for the Licensed Products.

6.
COMMERCIALIZATION

6.1.
Operational Control. From and after the Effective Date, with respect to
Franchise Product 1 and Franchise Product 2, and from and after the Option
Exercise Date, with respect to Franchise Product 3, Novartis shall have sole
responsibility for Commercialization of the Licensed Products in the Field in
the Territory. Such Commercialization shall be conducted in accordance with the
then-current Territory Brand Plan consistent with the Global Brand Plan and
approved by the JSC. Subject to the foregoing, Novartis’s responsibilities from
and after the Effective Date, with respect to Franchise Product 1 and Franchise
Product 2, and from and after the Option Exercise Date, with respect to
Franchise Product 3, shall include: (i) determination of commercial strategies
(e.g., strategies for branding, product positioning, pre-launch activities
(e.g., market research), launch sequence, launch and post-launch marketing and
promotion, pricing and reimbursement and field sales force optimization); (ii)
determination of packaging and labeling; (iii) creation of promotional materials
regarding the Licensed Products which are intended for distribution to Third
Parties (including medical professionals) and to Novartis’s sales force (subject
to Section 4.6 (Trademark Quality Standards) and Section 6.2 (Promotional
Materials)); (iv) determining and conducting promotion activities; and
(v) conducting sales and distribution activities, including pricing and liaising
with the applicable Governmental Authority in connection with any applicable
Pricing Approval, booking sales (i.e., recognizing all revenues), taking orders
and distributing, contracting, handling of returns, handling all aspects of
order processing, invoicing and collecting, warehousing, documenting inventory
and receivables, call reporting, handling data regarding sales to hospitals and
other end users and handling all other customer service-related functions.
Novartis shall be solely responsible for its costs incurred in its
Commercialization of the Licensed Products.

6.2.
Promotional Materials. Each Party shall only prepare and use promotional
materials that are compliant with applicable Law and are consistent with, in
respect of Novartis, the Global Brand Plan and the Territory Brand Plan, and in
respect of Amgen, the Global Brand Plan. Upon reasonable request, each Party
shall provide to the other Party copies of the key promotional materials used by
such providing Party in the Territory (in respect of Novartis) or outside the
Territory (in respect of Amgen) with respect to Licensed Products.

6.3.
Commercialization Outside the Territory. Except as expressly set forth in this
Agreement, Amgen shall be solely responsible for the Commercialization of the
Licensed Products outside the Territory and the costs thereof. Novartis shall
have no rights with respect thereto.

6.4.
Reimportation. To the extent permitted by applicable Law, each Party shall use
Commercially Reasonable Efforts to prevent Licensed Products provided to or made
for or on behalf of such Party for use or sale inside the Territory with respect
to Novartis or outside of the Territory with respect to Amgen from being
distributed or sold in the other Party’s territory, except where Amgen and
Novartis agree that the exporting person or entity is in possession of all
regulatory authorizations and intellectual property licenses necessary for

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

such export, import and sale. Each Party shall notify the other Party if it
becomes aware of the exportation of Licensed Products from its territory and
discuss with the other Party the same.

6.5.
Cooperation Generally. Subject to the oversight of the JSC, the Parties shall
cooperate generally with respect to the Commercialization of the Licensed
Products in the Field in the Territory.

6.6.
[*].[*]

7.
DILIGENCE; ACTIVITIES OUTSIDE THE COLLABORATION

7.1.
Commercially Reasonable Efforts. From and after the Effective Date, with respect
to Franchise Product 1 and Franchise Product 2, and from and after the Option
Exercise Date, with respect to Franchise Product 3, Novartis shall use
Commercially Reasonable Efforts to (i) Develop the Licensed Products in the
Field as contemplated under the applicable Development Plan; (ii) conduct
Medical Affairs Activities for each Licensed Product in the Field in the
Territory as contemplated by this Agreement; and (iii) Commercialize each
Licensed Product in the Field in the Territory following the issuance of
Regulatory Approval for such Licensed Product in the Field in the Territory;
provided that the Parties acknowledge that such Commercialization activities
shall be subject to the Territory Brand Plan and in accordance with the Global
Brand Plan.

7.2.
Activities Outside the Collaboration. Except as set forth in Sections 7.3
(Post-Effective Date Affiliates) and 7.4 ([*] Divestiture), during the Term,
neither Party shall, itself or through its Affiliates, directly or indirectly
conduct or participate in, or advise, assist or enable a Third Party to conduct
or participate in, any Distracting Program.

7.3.
Post-Effective Date Affiliates. In the event that a Party enters into a
Distracting Transaction with a Third Party, then such Party shall provide prompt
written notice to the other Party. Until the provisions of Section 7.4 ([*]
Divestiture) are effectuated, each Party shall ensure that information and
materials relating to the Collaboration are not shared with or used for the
benefit of, and are Segregated from, such Distracting Transaction Affiliate(s).

7.4.
[*] Divestiture. The notice provided pursuant to Section 7.3 (Post-Effective
Date Affiliates) shall include a notification as to whether such Party intends
to: (i) Divest the Distracting Program, in which case such Party shall hold
separate such Distracting Program (including Segregating such Distracting
Program from the Collaboration) and use its commercially reasonable, good-faith
efforts to Divest such Distracting Program; (ii) terminate such Distracting
Program, in which case such Party shall terminate all activities of such program
within [*] days after the closing of the Distracting Transaction, during which
period such Party shall hold separate such Distracting Program (including
Segregating such Distracting Program from the Collaboration); or (iii) in the
case of Amgen only, [*] or, in the case of Novartis, [*], in each case within
[*] days after the closing of the Distracting Transaction. In the event such
Party selects to Divest the Distracting Program under subsection (i) and fails
to complete such Divestiture within [*] of the closing of the Distracting
Transaction, then such Party shall be deemed to have chosen to terminate such
Distracting Program and

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shall promptly, and no later than within [*] days, comply with the requirements
of subsection (ii), above.

8.
MANUFACTURE AND SUPPLY

8.1.
Manufacturing Rights. Except in the case of failure to supply as provided in the
applicable Supply Agreement, Novartis shall not Manufacture any Licensed Product
or obtain any Licensed Product from any entity other than Amgen or its designee.

8.2.
Supply. Except in the case of failure to supply as may be provided in the
applicable Supply Agreement, Novartis shall obtain its requirements of each
Licensed Product in [*] for use in clinical Development or for commercial sale
solely from Amgen (or Amgen’s designee as permitted under the applicable Supply
Agreement) at Amgen’s cost. Amgen shall have the right to transition [*] to
Novartis on a region-by-region basis and subject to a mutually agreed upon
(i) notice and transfer period, (ii) transfer plan and (iii) transfer costs.
Amgen may consider and grant requests from Novartis to transition [*] to
Novartis on a region-by-region basis. Promptly (but in any event, within [*]
days) following the Effective Date, the Parties shall negotiate in good faith a
supply agreement for commercial supply of Franchise Product 1 in [*] to Novartis
for use in the Territory and supply agreements for clinical supply of Franchise
Product 1 and Franchise Product 2. Promptly (but in any event, within [*] days)
following the Option Exercise Date, the Parties shall negotiate in good faith a
supply agreement for clinical supply of Licensed Product 3. Promptly (but in any
event, at least [*] prior to anticipated launch of a Licensed Product (other
than Franchise Product 1), the Parties shall negotiate in good faith a supply
agreement for commercial supply of such Licensed Product. Each of the foregoing
supply agreements shall be referred to herein as a “Supply Agreement”. Each
Supply Agreement shall include provisions relating to (i) forecasts and orders,
and (ii) representations that the Licensed Product will be Manufactured
according to specifications and in accordance with cGMP. The terms for providing
clinical and commercial supply for Franchise Product 1 shall be materially
consistent with the Clinical Supply Schedule and the Commercial Supply Schedule,
respectively. The terms for providing clinical and commercial supply for
Franchise Product 2 and Franchise Product 3, if applicable, shall be
substantially similar to the terms of the Clinical Supply Schedule and the
Commercial Supply Schedule, respectively, except for example with respect to the
actual amount of the manufacturing cost cap.

8.3.
Quality Agreement. Promptly (but in any event, within [*] days) following the
Effective Date, with respect to Franchise Product 1 and Franchise Product 2, and
promptly (but in any event, within [*] days) following the Option Exercise Date,
with respect to Franchise Product 3, Amgen and Novartis shall develop and agree
upon a quality agreement governing the quality and specifications of clinical
and commercial Licensed Products to be supplied hereunder (each, a “Quality
Agreement”). Each Quality Agreement shall include provisions relating to (i) the
handling of Recalls and product complaints relating to such Licensed Product in
the Territory, (ii) Manufacturer release of Licensed Product, (iii) facility
inspections by Governmental Authorities and Novartis and (iv) change management
with respect to Manufacture of such Licensed Product. Without limitation of the
foregoing, the Quality Agreement shall also include provisions to [*]. Each
Quality Agreement shall be documented in writing, and routinely updated by
mutual written agreement of the Parties.

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

8.4.
Responsibility for Regulatory Filings with Respect to Manufacturing; Inspections
of Manufacturing Facilities. Amgen shall develop [*] a [*] Marketing Application
Core Dossier (the “CMC Core Dossier”) for the purpose of [*]. [*] shall [*] the
table of contents for the CMC Core Dossier and, with respect to [*], the [*]
strategic plan for the CMC Core Dossier for such jurisdictions, including
developing key messages planned in the CMC Core Dossier, determining data
planned to support such key messages, and identifying risks within such key
messages and data in such jurisdictions, consistent with Amgen’s standard
procedures. Based on such table of contents and strategic plan, Amgen shall
prepare the draft of the CMC Core Dossier and provide such draft to Novartis for
review and comment. Novartis shall participate in the authoring process for the
CMC Core Dossier by providing its comments to Amgen reasonably promptly, which
Amgen shall consider in good faith. Following provision of the [*] CMC Core
Dossier to Novartis, [*]. As between the Parties, Novartis shall have
responsibility for the assessment by Governmental Authorities of [*] with
respect to Licensed Products in the Territory and Amgen shall have
responsibility for the [*] with respect to Licensed Products outside the
Territory. Novartis shall have no right to participate in inspections by any
Governmental Authority of any facility where any Licensed Product is
Manufactured, whether prior to or after Regulatory Approval of such Licensed
Product. For avoidance of doubt, all information disclosed by Amgen under this
Section 8.4 (Responsibility for Regulatory Filings with Respect to
Manufacturing; Inspections of Manufacturing Facilities) shall be subject to the
restrictions set forth in Section 11.2 (Authorized Disclosure).

9.
PAYMENT

9.1.
Royalty Payments. As partial consideration for the rights granted to Novartis
hereunder, subject to Section 9.2 (Royalty Reduction), Novartis shall pay Amgen
a royalty on annual Net Sales of each Licensed Product for each Calendar Year
(or portion thereof) during the applicable Royalty Term at the following rates:

Net Sales in the Territory of the Applicable Licensed Product
Royalty Rate for Franchise Product 1
Royalty Rate for Franchise Product 2
Royalty Rate for Franchise Product 3
For that portion of annual Net Sales of the Licensed Product in the Territory
less than [*]
[*]%
[*]%
[*]%
For that portion of annual Net Sales of the Licensed Product in the Territory
equal to or greater than [*] but less than [*]
[*]%
[*]%
[*]%
For that portion of annual Net Sales of the Licensed Product in the Territory
equal to or greater than [*] but less than [*]
[*]%
[*]%
[*]%
For that portion of annual Net Sales of the Licensed Product in the Territory
equal to or greater than [*]
[*]%
[*]%
[*]%

9.2.
Royalty Reduction.

9.2.1.
Biosimilar Competition. Notwithstanding the foregoing, if, following the first
commercial sale of a Biosimilar Product of a given Licensed Product in a given

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subject to a request for confidential treatment that has been filed with the
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country, Net Sales of such Licensed Product in that country in any Calendar Year
are less than [*] percent ([*]%) as compared with Net Sales of such Licensed
Product in the [*] month period in that country immediately preceding the
marketing or sale of a Biosimilar Product of such Licensed Product in such
country, the applicable Net Sales from such country based upon which royalties
are calculated shall be reduced by [*] percent ([*]%) for purposes of the
calculation of such royalties. Notwithstanding the foregoing, [*].
9.2.2.
Third Party Payments. If Novartis or any of its Affiliates or sublicensees
determines in its good faith judgment with advice from legal counsel that it is
necessary or advisable to obtain a license from any Third Party in order to use,
sell, offer for sale or import any Licensed Product in the Field in the
Territory, then Novartis shall promptly notify Amgen and shall use commercially
reasonable efforts to negotiate a favorable economic license to minimize
payments by Novartis (and deductions from amounts otherwise payable to Amgen),
and if Novartis obtains such a license, Novartis will be entitled to deduct up
to [*] percent ([*]%) of any payments (including fees, milestones, royalties,
settlements, payments or other payments) under such license for a given Calendar
Quarter, to the extent such payments and license relate to such Licensed
Product, from the royalties otherwise payable under Section 9.1 (Royalty
Payments) with respect to such Licensed Product for such same Calendar Quarter;
provided, however, that in no event shall the aggregate royalties payable to
Amgen for a given Licensed Product for a given Calendar Quarter be reduced
pursuant to this Section 9.2.2 (Third Party Payments) to less than [*] percent
([*]%) of the amounts otherwise payable under Section 9.1 (Royalty Payments)
with respect to such Licensed Product for such Calendar Quarter (the “[*]
Royalty Floor Restriction”); provided further that in no event shall the
royalties payable to Amgen for Franchise Product 1 be reduced to less than [*]
percent ([*]%) and for each of Franchise Product 2 and Franchise Product 3 be
reduced to less than [*] percent ([*]%); and provided further that any excess
amounts that are not deducted and would have been deductible from the royalty
payments in a given Calendar Quarter but for the application of the [*] Royalty
Floor Restriction or the foregoing [*] percent ([*]%) or [*] percent ([*]%)
floors, may be deducted by Novartis in succeeding Calendar Quarter(s), as
necessary, until such excess amounts are reimbursed to Novartis in full. The
foregoing shall be without prejudice to Section 9.8 (Sublicense Payments),
provided that, in the event Novartis proposes to enter into a license with
respect to any intellectual property described in clause (ii) of Section 9.8
(Sublicense Payments), to the extent Amgen has notified Novartis of the license
or acquisition relating to such intellectual property, Novartis shall obtain
Amgen’s written consent (not to be unreasonably withheld or delayed) prior to
entering into any such license.

9.2.3.
Maximum Reduction. Notwithstanding the foregoing, in no event shall the
operation of Sections 9.2.1 (Biosimilar Competition) and 9.2.2 (Third Party
Payments) together operate to reduce the royalties otherwise payable to Amgen
hereunder by more than [*] percent ([*]%) other than as and to the extent set
forth in the last sentence of Section 9.2.1 (Biosimilar Competition).

9.3.
[Reserved].

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

9.4.
Appropriate Measure of Value. Each of the Parties acknowledges that the value
provided by the other hereunder is comprised of many related items, including
intellectual property of various types, access to Development and commercial
expertise, clinical data and other financial and non-financial consideration and
that the royalties set forth in Section 9.1 (Royalty Payments) are intended to
capture such value as an aggregate. Therefore the increase, decrease or lapse of
any particular items or rights shall not affect the amount of such royalty, and
the Parties agree that both the amount and duration of the royalties set forth
in this Article 9 (Payment) are reasonable.

9.5.
Reports.

9.5.1.
Beginning with the Calendar Quarter in which the First Commercial Sale of a
given Licensed Product in the Territory occurs and thereafter for each Calendar
Quarter until the expiration of Novartis’s obligation to pay royalties with
respect to such Licensed Product hereunder, reports of the sale of such Licensed
Product for each Calendar Quarter will be delivered by Novartis to Amgen under
this Agreement within [*] days after the end of each such Calendar Quarter. Such
report shall state: (i) Net Sales of such Licensed Product by or on behalf of
Novartis, its Affiliates or sublicensees during the applicable Calendar Quarter
(detailed country-by-country); and (ii) a calculation of the royalty payment due
from Novartis hereunder for such Calendar Quarter.

9.5.2.
Based on the report received by Amgen from Novartis pursuant to Section 9.5.1
and without prejudice to Section 9.11 (Audits), Amgen shall issue an invoice to
Novartis for the amount of the royalty payments indicated in the report.
Following receipt of such invoice, to the extent that Novartis does not dispute,
in good faith, the amount set forth on such invoice, Novartis shall pay the
amount of the royalty payments indicated on such invoice within [*] days to an
account designated by Amgen.

9.5.3.
Any reports which contain currency conversions shall provide the details and
background information used to calculate such conversions. With respect to Net
Sales invoiced or expenses incurred in a currency other than U.S. Dollars, such
Net Sales invoiced or expenses incurred shall be converted into the U.S. Dollar
equivalent using a rate of exchange which corresponds to the rate used by the
Party recording Net Sales (or an Affiliate) uses for purposes of calculating its
financial reports. Any royalty amount shall be calculated based upon the U.S.
Dollar equivalent calculated in accordance with the foregoing.

9.6.
No Wrongful Reductions. Novartis shall not attempt to reduce compensation
rightly due to Amgen hereunder by shifting compensation otherwise payable to
Novartis from a Third Party with respect to any Licensed Product to another
product or service for which no royalties are payable by it hereunder.

9.7.
Development Cost Sharing.

9.7.1.
General. In addition to the other payments referenced herein, with respect to
each Licensed Product, Novartis shall bear the percentage of Amgen Development
Costs set forth in the “Novartis Share” column of the applicable chart below and
Amgen shall bear the percentage of Novartis Development Costs set forth in the
“Amgen

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Share” column of the chart below, in each case, that are included in the
applicable Development Budget.
Franchise Product 1 Development Costs
Novartis Share
Amgen Share
[*]
[*]%
[*]%
[*]
[*]%
[*]%
[*]
[*]%
[*]%
[*]
[*]%
[*]%
[*]
[*]%
[*]%

Franchise Product 2 Development Costs
Novartis Share
Amgen Share
[*]
[*]%
[*]%
[*]
[*]%
[*]%

Franchise Product 3 Development Costs*
Novartis Share
Amgen Share
[*]
[*]%
[*]%
[*]
[*]%
[*]%

*The percentages listed above with respect to Franchise Product 3 shall only
apply if the Option Exercise Date occurs prior to the expiration of Option
Period 1.
In the event that the Option Exercise Date occurs after the expiration of Option
Period 1, Novartis shall bear the percentage of Amgen Development Costs set
forth in the “Novartis Share” column of the applicable chart below and Amgen
shall bear the percentage of Novartis Development Costs set forth in the “Amgen
Share” column of the chart below, in each case, that are included in the
applicable Development Budget.

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Franchise Product 3 Development Costs
Novartis Share
Amgen Share
[*]
[*]%
[*]%
[*]
[*]%
[*]%
[*]
[*]%
[*]%
[*]
[*]%
[*]%

9.7.2.
Annual Development Budget Overruns. With respect to each Licensed Product, each
Party shall promptly notify the other Party upon becoming aware that its
Development Costs to be incurred in performing the applicable Development Plan
for a Calendar Year will be in excess of the amounts budgeted to be incurred by
or on behalf of such Party for its activities in the applicable Annual
Development Budget. If the aggregate Development Costs incurred by a Party for
performing the applicable Development Plan for a Calendar Year exceed the
amounts budgeted to be incurred by or on behalf of such Party for its activities
in the applicable Annual Development Budget, the other Party shall reimburse the
performing Party for the applicable percentage set forth above of such excess;
provided that (i) in no event shall Novartis be responsible for reimbursement
for such excesses to the extent the Amgen Development Costs in performing the
Development Plan (a) for [*], exceed the amounts budgeted to be incurred by or
on behalf of Amgen for its activities in the applicable Annual Development
Budget for such Calendar Year, and (b) for [*], exceed the amounts budgeted to
be incurred by or on behalf of Amgen for its activities in the applicable Annual
Development Budget for such Calendar Year by more than [*] percent ([*]%) and
(ii) in no event shall Amgen be responsible for reimbursement for such excesses
to the extent the Novartis Development Costs in performing the Development Plan
for a Calendar Year exceed the amounts budgeted to be incurred by or on behalf
of Novartis for its activities in the applicable Annual Development Budget for
such Calendar Year by more than [*] percent ([*]%); provided that a Party shall
be responsible for reimbursement for such excesses to the extent that the Amgen
Development Costs or Novartis Development Costs, as the case may be, are
attributable to (a) a change in applicable Law, (b) a Force Majeure event,
(c) [*], (d) [*] or (e) a mutually agreed amendment to the applicable
Development Plan.

9.7.3.
Reports. Within [*] days after the end of each Calendar Quarter, each Party
shall provide the other Party with a report specifying in reasonable detail
(which shall include system-generated time-tracking data) the Development Costs
(including Development Costs in respect of any clinical study undertaken by the
providing Party that have been approved by the other Party or the regulatory
materials and data from any clinical study such other Party wishes to cross
reference, file or incorporate by reference in a Regulatory Filing as described
in Section 5.2.2 (Development Outside the Current Development Plan) or Section
5.3 (Development Outside the Territory)) for such Party in such Calendar
Quarter, as well as any other costs for

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

which such Party is entitled to reimbursement hereunder. Such Development Costs
may be attributed by such Party to either the Calendar Quarter in which they are
expensed.
9.7.4.
Payments. Based on the report received from the other Party pursuant to Section
9.7.3 (Reports), the Party which has borne more than its share of Development
Costs as determined pursuant to Section 9.7.1 (General) shall issue an invoice
to the owing Party for such excess amount in accordance with Section 9.10
(Payment Method) within [*] days after receiving the other Party’s report
pursuant to Section 9.7.3 (Reports).

9.7.5.
Budget Deadlocks. In the event that the JSC is unable to approve an Annual
Development Budget for a Calendar Year prior to the start of such Calendar Year,
then, until approval of such budget by the JSC, (i) the Annual Development
Budget most recently approved by the JSC for such Calendar Year (or if not JSC
approved, the initial apportioned amount for such Calendar Year in the
applicable initial Development Budget agreed in writing by the Parties on or
after the Effective Date) shall apply and (ii) if not approved by the JSC and no
apportioned amount for such Calendar Year is included in such Development
Budget, then the apportionment for the prior Calendar Year shall apply. In the
event that the JSC is unable to approve an annual apportionment of a Study
Budget for a Calendar Year prior to the start of such Calendar Year, then, until
approval of such annual budget by the JSC, (a) the amount apportioned for such
Calendar Year in the most recent Study Budget approved by the JSC for such Study
Plan (or if not JSC approved, the initial apportioned amount for such Calendar
Year in such Study Budget) shall apply; and (b) if not approved by the JSC and
no apportioned amount for such Calendar Year is included in such Study Budget,
then the apportionment for the prior Calendar Year shall apply.

9.8.
Sublicense Payments. Amgen shall be responsible for any Third Party license
fees, milestones, royalties or other payments owed with respect to any Licensed
Product, on intellectual property that: (i) is licensed by Amgen prior to or as
of the Effective Date or (ii) is licensed or acquired by Amgen after the
Effective Date [*]. For the avoidance of doubt, such Third Party payments shall
not be included in any calculation of Development Costs.

9.9.
[Reserved.]

9.10.
Payment Method. All amounts in this Agreement are expressed in U.S. Dollars. All
payments made hereunder between the Parties shall be made in U.S. Dollars except
as set forth in Section 9.12 (Blocked Currency). Any sales incurred in a
currency other than U.S. Dollars shall be converted to the U.S. Dollar
equivalent using Novartis’ then-current standard exchange rate methodology as
applied in its external reporting for the conversion of foreign currency sales
into U.S. Dollars. Each Party shall pay all sums due hereunder by check, wire
transfer, or electronic funds transfer (EFT) in immediately available funds.
Each Party will promptly notify the other Party of the appropriate account
information to facilitate any such payments. Regardless of the amounts of any
royalties or other payments due under this Agreement or any other agreement
between the Parties or their Affiliates, all amounts payable

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

under this Agreement shall be paid in full (subject to Section 9.14
(Withholding) and Section 9.15 (VAT)).

9.11.
Audits. Novartis shall keep complete and accurate records pertaining to Novartis
Development Costs and to the underlying revenue and expenses data relating to
the calculation of Net Sales for the Licensed Products in the Territory in
sufficient detail to permit Amgen to confirm the accuracy of all payments due
hereunder, including Amgen’s obligation to reimburse Novartis for Amgen’s share
of Novartis Development Costs pursuant to Section 9.7 (Development Cost
Sharing). Amgen shall keep complete and accurate records pertaining to Amgen
Development Costs of Licensed Products in sufficient detail to permit Novartis
to reasonably confirm the accuracy of all payments due hereunder with respect to
Novartis’s obligation to reimburse Amgen for Novartis’s share of Amgen
Development Costs pursuant to Section 9.7 (Development Cost Sharing). Such
records of Novartis and Amgen shall be open (in such form as may be available or
reasonably requested by an internationally recognized certified public
accounting firm in accordance with this Section 9.11 (Audits)) to inspection for
three (3) years following the end of the period to which they pertain. Each
Party shall have the right, at its own expense, to have an independent,
internationally recognized certified public accounting firm, selected by it
review the records of the other Party upon reasonable notice and during regular
business hours and under reasonable obligations of confidentiality. The report
of such accounting firm shall be made available to both Parties simultaneously,
promptly upon its completion; provided, however, that the Party being audited
shall have the right to review and comment on the final draft version of the
report prior to it being finalized. Such review and comment period shall extend
for four (4) weeks after the audited Party’s receipt of such draft report. Each
Party’s audit rights with respect to any Calendar Year shall expire three (3)
years after the end of such year and the books and records for any particular
Calendar Year shall only be subject to one (1) audit. Should the inspection lead
to the discovery of a discrepancy to the auditing Party’s detriment, then the
other Party shall pay to the auditing Party the amount of the discrepancy.
Should the inspection lead to the discovery of a discrepancy to the detriment of
the Party being audited, then the auditing Party shall pay to the Party being
audited the amount of the discrepancy. The auditing Party shall pay the full
cost of the inspection unless the discrepancy is to the detriment of the
auditing Party and is greater than [*] percent ([*]%) of the amount actually
paid for the audited period, in which case the Party being audited shall pay the
cost of such inspection.

9.12.
Blocked Currency. If at any time legal restrictions in the Territory prevent the
prompt remittance of any payments with respect to sales therein, Novartis shall
have the right and option to make such payments by depositing the amount thereof
in local currency to Amgen’s account in a bank or depository designated by Amgen
in the Territory.

9.13.
Taxes. All Taxes levied on account of a payment made by Novartis to Amgen
pursuant to this Agreement will be subject to the withholding and remittance
provisions of Section 9.14 (Withholding). Except as otherwise provided, each
Party will be responsible for its own taxes, fees, duties or similar amounts
levied on account of any payments made to it under this Agreement.

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

9.14.
Withholding. In the event that Law requires Novartis to pay or withhold Taxes
with respect to any payment to be made by Novartis pursuant to this Agreement,
Novartis shall notify Amgen in writing of such payment or withholding
requirements prior to making the payment to Amgen and provide such assistance to
Amgen, including the provision of such documentation as may be required by a tax
authority, as may be reasonably necessary in Amgen’s efforts to claim an
exemption from or reduction of such Taxes. Novartis will, in accordance with
Law, withhold Taxes from the amount due, remit such Taxes to the appropriate tax
authority, and furnish Amgen with proof of payment of such Taxes within fifteen
(15) Business Days following obtaining the relevant payment certificate. If
Taxes are paid to a tax authority, Novartis shall provide such assistance to
Amgen as is reasonably required to obtain a refund of Taxes withheld, or obtain
a credit with respect to Taxes paid. Further, the Parties agree that no gross up
mechanism or similar type adjustment will apply to such net payment.
Notwithstanding the foregoing, in the event that Novartis unilaterally
restructures the payment of any royalty or any other monies payable to Amgen
under this Agreement such that Novartis or any of its Affiliates makes the
payment of such royalty or any other monies payable to Amgen under this
Agreement and solely as a result of such unilateral restructuring said amount is
subject to withholding and further, Amgen is not able to recover or credit all
or part of such withheld amount(s), Novartis agrees to compensate, without
interest, Amgen for the corresponding economic impact of such non-recoverable or
non-creditable amount. Such compensation must be made within a reasonable
timeframe, upon request of Amgen. For the avoidance of doubt, the preceding
sentence shall apply only in respect of a unilateral restructuring of payments
by Novartis and shall not apply (x) in the event of a change in applicable Law
or circumstance, (y) as the result of Amgen’s inability to recover or credit
such withholding on a current or future basis due to Amgen’s taxable income
(loss) position or other tax attributes in a given year, or (z) for any other
reason beyond the exclusive control of Novartis.

9.15.
VAT. All payments due Amgen from Novartis pursuant to this Agreement shall be
paid exclusive of any VAT (which, if applicable, shall be payable by Novartis
upon receipt of a valid VAT invoice).

9.16.
Late Payment. Any payments or portions thereof due hereunder which are not paid
when due shall bear interest at the Contract Interest Rate calculated on the
number of days such payment is delinquent. This Section 9.16 (Late Payment)
shall in no way limit any other remedies available to either Party.

10.
INTELLECTUAL PROPERTY

10.1.
Ownership and Cooperation.

10.1.1.
Except to the extent expressly specified to the contrary in this Agreement:
(i) each Party shall retain and own all right, title, and interest in and to all
patent rights, trade secrets, proprietary rights and other intellectual property
rights conceived or created solely by such Party; (ii) the Parties shall jointly
own all right, title, and interest in and to all patent rights, trade secrets,
proprietary rights and other intellectual property rights conceived or created
jointly by the Parties pursuant to the Collaboration and, subject to the
provisions of this Agreement (including those licenses granted pursuant

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

to Article 4 (Grant of License)), neither Party shall have any duty to account
or obtain the consent of the other Party (such consent deemed given hereunder)
in order to exploit, license or assign such intellectual property rights; and
(iii) inventorship and authorship of any invention or work of authorship
conceived or created by either Party or jointly by the Parties pursuant to the
Collaboration, shall follow the rules of the U.S. Patent and Trademark Office
and the Laws of the U.S. (without reference to any conflict of law principles).
10.1.2.
Each Party shall promptly notify the other upon becoming aware (i) of any
actual, suspected or threatened material infringement of any Licensed Amgen
Patents, Licensed Amgen Trademarks or Licensed Amgen Know-How, (ii) of any claim
that Novartis’s, or its Affiliates’ or sublicensees’, exercise of the rights
granted under the Licensed Amgen Patents Licensed Amgen Trademarks, or Licensed
Amgen Know-How hereunder infringes any rights or patents of a Third Party, (iii)
of any claims of alleged patent or trademark infringement by Amgen or Novartis
with respect to the Manufacture, use, sale, offer for sale or importation of the
Licensed Product, (iv) of any actual, suspected or threatened material
misappropriation of Licensed Amgen Know-How, and/or (v) of any actual, suspected
or threatened material infringement or dilution of the Licensed Amgen
Trademarks, Amgen Housemarks related to the Licensed Products or Novartis
Housemarks related to the Licensed Products, all of the foregoing, (i) through
(v), anywhere in the world.

10.2.
Prosecution and Maintenance.

10.2.1.
In Territory.

10.2.1.1.
Amgen Primary Prosecution. Amgen shall control, itself or through outside
counsel reasonably acceptable to Novartis and directed by Amgen, the
preparation, filing (including filing for correction of claims or
specifications), prosecution, maintenance and defense (including responses to
patent or trademark office communications, any office actions, oppositions,
interferences and challenges (whether before a patent or trademark authority or
judicial body) related thereto) (the foregoing collectively “Patent and
Trademark Matters”) with respect to Licensed Amgen Patents, Licensed Amgen
Trademarks and Joint Patents (in which case the prosecution will be in the name
of both Parties), in each case solely in the Territory (collectively, the
“Territory Patents and Trademarks”), as well as preparation and filing for any
patent term extensions or similar protections therefor. Novartis shall be
responsible for reasonable, documented costs incurred by or on behalf of Amgen
in connection with such activities with respect to the Territory Patents and
Trademarks (other than the costs associated with the creative development of
Trademarks and related availability searches). Within [*] days following each
Calendar Quarter, Amgen shall provide Novartis an invoice setting forth such
costs in reasonable detail, and Novartis shall pay such invoice within [*] days
of receipt thereof. From and after the Effective Date, with respect to Territory
Patents and Trademarks related to Franchise Product 1 and Franchise Product 2,
and from and after the Option Exercise Date, with respect

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to Territory Patents and Trademarks related to Franchise Product 3, (i) Amgen
shall provide Novartis with copies of and an opportunity to review and comment
upon the text of the applications relating to the Territory Patents and
Trademarks as soon as practicable (but in no event less than [*] days for new
patent application filings and [*] days for all other filings or correspondence
before submission thereof) before filing, (ii) Amgen shall provide Novartis with
a copy of each submission made to and document received from a patent or
trademark authority, court or other tribunal regarding any Territory Patents and
Trademarks reasonably promptly after making such filing or receiving such
document, including a copy of each application for each item within the
Territory Patents and Trademarks as filed together with notice of its filing
date and application number, (iii) Amgen shall keep Novartis advised of the
status of all material communications, actual and prospective filings or
submissions regarding the Territory Patents and Trademarks, and shall give
Novartis copies of and an opportunity to review and comment on any such material
communications, filings and submissions proposed to be sent to any patent or
trademark authority or judicial body, and (iv) Amgen shall reasonably consider
in good faith Novartis’s comments on the communications, filings and submissions
for the Territory Patents and Trademarks.
10.2.1.2.
Patent and Trademark Prosecution Strategy. No later than [*] days after the date
of this Agreement, [*].

10.2.1.3.
Novartis Secondary Prosecution. From and after the Effective Date, with respect
to Territory Patents and Trademarks related to Franchise Product 1 and Franchise
Product 2, and from and after the Option Exercise Date, with respect to
Territory Patents and Trademarks related to Franchise Product 3, if Amgen
proposes to abandon or fail to maintain any patent, trademark or application
within the Territory Patents and Trademarks, it shall give Novartis reasonable
notice thereof (with sufficient time for Novartis to assume control thereof and
continue the prosecution or maintenance of such patent, trademark or
application) and thereafter Novartis may, upon written notice to Amgen and at
Novartis’s sole cost, control Patent and Trademark Matters with respect to such
patent, trademark or application within the Territory Patents and Trademarks
thereafter in accordance with this Section 10.2.1.3 (Novartis Secondary
Prosecution) (any patent, trademark or application so assumed, a “Novartis
Assumed Item”). Novartis shall control, itself or through outside counsel
reasonably acceptable to the Parties and directed by Novartis, Patent and
Trademark Matters with respect to Novartis Assumed Items in the Territory, at
Novartis’s sole cost and expense, as well as preparation and filing for any
patent term extensions or similar protections therefor. Novartis shall provide
Amgen with a copy of each material submission made to and document received from
a patent or trademark authority regarding any Novartis Assumed Items reasonably
promptly after making such filing or

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receiving such document, including a copy of each application for each item
within the Novartis Assumed Items as filed together with notice of its filing
date and application number.
10.2.2.
Outside Territory. Amgen shall control and be solely responsible for all Patent
and Trademark Matters with respect to its patent rights, trademark rights and
other intellectual property outside the Territory, at its sole cost and expense.
Amgen shall control and be solely responsible for Patent and Trademark Matters
with respect to Joint Patents outside the Territory, at its sole cost and
expense. Notwithstanding the other provisions of this Section 10.2.2 (Outside
Territory), without the prior written consent of Novartis, Amgen shall not take
any action (or fail to take any action) with respect to such intellectual
property or Joint Patents [*] that would reasonably be expected to [*] the
Licensed Amgen Patents or the research, Development, conduct of Medical Affairs
Activities with respect to, use or Commercialization of Licensed Products [*].

10.3.
Defense and Settlement of Third Party Claims.

10.3.1.
Territory Patents and Trademarks. From and after the Effective Date, with
respect to Territory Patents and Trademarks related to Franchise Product 1 and
Franchise Product 2, and from and after the Option Exercise Date, with respect
to Territory Patents and Trademarks related to Franchise Product 3, if a Third
Party asserts that a patent right or other right owned by it is infringed by the
manufacture, use, offer for sale, sale or importation of the Licensed Product in
the Territory by Novartis, Novartis shall have the sole right to defend against
any such assertions at its sole cost. Amgen shall reasonably assist Novartis and
cooperate in any such litigation at Novartis’s request, and Novartis shall
reimburse Amgen any reasonable, documented, out-of-pocket costs incurred in
connection therewith. Subject to such control, Amgen may join any defense and
settlement pursuant to this Section 10.3 (Defense and Settlement of Third Party
Claims), with its own counsel at its sole cost. Novartis shall seek and
reasonably consider Amgen’s comments before determining the strategy for such
matter. Without limiting the foregoing, Novartis shall keep Amgen advised of all
material communications, actual and prospective filings or submissions regarding
such action, and shall provide Amgen copies of and an opportunity to review and
comment on any such communications, filings and submissions. Novartis shall not
settle or consent to the entry of any judgment in any such action [*]. Novartis
shall keep Amgen fully informed of all claims and actions governed by this
Section 10.3 (Defense and Settlement of Third Party Claims). In the event
Novartis becomes engaged in: (i) settlement discussions with a Third Party that
has specifically asserted that a patent right or trademark right of such Third
Party would be infringed by the use, offer for sale, sale or importation of the
Licensed Product; (ii) settlement discussions of an interference involving a
patent corresponding to a Licensed Amgen Patent or a trademark corresponding to
a Licensed Amgen Trademark; or (iii) cross-license discussions with respect to a
patent corresponding to a Licensed Amgen Patent or a trademark corresponding to
a Licensed Amgen Trademark; and, in each such case, such Third-Party patent
right or trademark right corresponds to a patent right or trademark right
outside the

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Territory: (a) Novartis shall keep Amgen reasonably informed of the status of
such discussions; and (b) Novartis shall consider in good faith any comments or
suggestions of Amgen.
10.3.2.
Ex-Territory Patents and Trademarks.  From and after the Effective Date, with
respect to Licensed Amgen Patents, Licensed Amgen Trademarks and Joint Patents,
in each case outside the Territory (collectively, the “Ex-Territory Patents and
Trademarks”) related to Franchise Product 1 and Franchise Product 2, and from
and after the Option Exercise Date, with respect to Ex-Territory Patents and
Trademarks related to Franchise Product 3, if a Third Party asserts that a
patent right or other right owned by it is infringed by the manufacture, use,
offer for sale, sale, or importation of the Licensed Product outside the
Territory by Amgen, Amgen shall have the sole right to defend against any such
assertions at its sole cost. Novartis shall reasonably assist Amgen and
cooperate in any such litigation at Amgen’s request, and Amgen shall reimburse
Novartis any reasonable, documented, out-of-pocket costs incurred in connection
therewith. Subject to such control, Novartis may join any defense and settlement
pursuant to this Section 10.3 (Defense and Settlement of Third Party Claims),
with its own counsel at its sole cost. Amgen shall seek and reasonably consider
Novartis’s comments before determining the strategy for such matter. Without
limiting the foregoing, Amgen shall keep Novartis advised of all material
communications, actual and prospective filings or submissions regarding such
action, and shall provide Novartis copies of and an opportunity to review and
comment on any such communications, filings and submissions. Amgen shall not
settle or consent to the entry of any judgment in any such action that would
reasonably be expected to [*] the Licensed Amgen Patents, the Licensed Amgen
Trademarks or the research, Development, conduct of Medical Affairs Activities
with respect to, use or Commercialization of Licensed Products [*]. Amgen shall
keep Novartis fully informed of all claims and actions governed by this Section
10.3 (Defense and Settlement of Third Party Claims). In the event Amgen becomes
engaged in: (i) settlement discussions with a Third Party that has specifically
asserted that a patent right or trademark right of such Third Party would be
infringed by the use, sale or importation of the Licensed Product; (ii)
settlement discussions of an interference involving a patent corresponding to a
Licensed Amgen Patent or a trademark corresponding to a Licensed Amgen
Trademark; or (iii) cross-license discussions with respect to a patent
corresponding to a Licensed Amgen Patent or a trademark corresponding to a
Licensed Amgen Trademark; and, in each such case, such Third-Party patent right
or trademark right corresponds to a patent right or trademark right inside the
Territory: (a) Amgen shall keep Novartis reasonably informed of the status of
such discussions; and (b) Amgen shall consider in good faith any comments or
suggestions of Novartis.

10.3.3.
Mutual Provisions. Each Party shall have the right to redact any information
disclosed to the other Party pursuant to this Section 10.3 (Defense and
Settlement of Third Party Claims) relating to any product other than the
applicable Licensed Product.

10.4.
Enforcement.

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10.4.1.
In Territory. Each Party shall promptly notify the other Party in writing if it
reasonably believes that any Territory Patents and Trademarks are infringed or
misappropriated by a Third Party in the Territory.

10.4.1.1.
Prior to Option Exercise Date with Respect to Franchise Product 3. Prior to the
Option Exercise Date, Amgen shall have the sole right, but not the obligation,
to enforce Territory Patents and Trademarks relating to Franchise Product 3
against any actual, alleged or threatened infringement or misappropriation by
Third Parties in the Territory, at Amgen’s sole cost.

10.4.1.2.
Novartis Primary Enforcement. From and after the Effective Date, with respect to
Territory Patents and Trademarks related to Franchise Product 1 and Franchise
Product 2, and from and after the Option Exercise Date, with respect to
Territory Patents and Trademarks related to Franchise Product 3, Novartis shall
have the first right, but not the obligation, to enforce Territory Patents and
Trademarks against any actual, alleged or threatened infringement or
misappropriation by Third Parties in the Territory, at Novartis’s sole cost,
subject to Section 10.5 (Cooperation). In the event Novartis elects to bring and
prosecute such an action, Amgen shall reasonably assist Novartis and cooperate
in any such action at Novartis’s request (and Novartis shall reimburse all
reasonable, documented, out-of-pocket expenses incurred by Amgen in connection
therewith), and Novartis shall seek and reasonably consider Amgen’s comments
before determining the strategy. Without limiting the foregoing, Novartis shall
keep Amgen advised of all material communications, actual and prospective
filings or submissions regarding such action, and shall provide Amgen copies of
and an opportunity to review and comment on any such material communications,
filings and submissions. Novartis shall not settle, or consent to any judgment
in, any action under this Section 10.4.1.2 (Novartis Primary Enforcement),
without Amgen’s prior written consent, not to be unreasonably withheld or
delayed.

10.4.1.3.
Amgen Secondary Enforcement. From and after the Effective Date, with respect to
Territory Patents and Trademarks related to Franchise Product 1 and Franchise
Product 2, and from and after the Option Exercise Date, with respect to
Territory Patents and Trademarks related to Franchise Product 3, in the event
Novartis does not commence an enforcement action or otherwise take action to
abate any alleged infringement or misappropriation of any Territory Patents and
Trademarks within [*] days after Amgen requests Novartis to do so in writing
(or, if later, within [*] days after such action can viably be brought by Law
(as, for example, in the case of expiration of a clinical trial exception to
patent infringement, and, if sooner, by such time as it would no longer be
possible to bring such action due to delay)), Amgen shall be entitled to bring
and prosecute such an action at Amgen’s sole cost and Novartis will cooperate
with Amgen. If Amgen elects to bring and prosecute such an action, then Amgen
shall seek and reasonably consider Novartis’s comments on strategy. Without
limiting the foregoing, Amgen shall keep Novartis advised of all material
communications, actual and prospective

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filings or submissions regarding such action, and shall provide Novartis copies
of and an opportunity to review and comment on any such material communications,
filings and submissions (provided that Amgen shall have the right to redact any
Amgen Manufacturing information and any information relating to any product
other than the Licensed Product from any such materials). Amgen shall not
settle, or consent to any judgment in, any action under this Section 10.4.1.3
(Amgen Secondary Enforcement) that would reasonably be expected to [*] the
Licensed Amgen Patents, the Licensed Amgen Trademarks or the research,
Development, conduct of Medical Affairs Activities with respect to, use or
Commercialization of Licensed Products [*].
10.4.2.
Outside Territory. Amgen shall have the sole right, but not the obligation, to
enforce its patent rights, trademark rights and other intellectual properties,
and the Joint Patents outside the Territory against any actual, alleged or
threatened infringement or misappropriation by Third Parties outside the
Territory, and to settle any such matters in its sole discretion subject to
Section 10.3 (Defense and Settlement of Third Party Claims). Novartis shall have
no right to enforce such rights outside the Territory.

10.5.
Cooperation. When either Party is bringing or defending an action of the type
described in Sections 10.3 (Defense and Settlement of Third Party Claims) or
10.4.1 (In Territory), then upon reasonable request by such a Party, the other
Party will reasonably assist in the defense against or enforcement of such
action at the requesting Party’s costs, including if required or desirable to
bring, maintain or prove damages in such action, furnishing a power of attorney,
furnishing documents and information, providing employee witnesses and executing
all necessary documents as such Party may reasonably request.

10.6.
Allocation of Recoveries. All Recoveries shall first be applied to reimbursement
of the unreimbursed legal fees and expenses reasonably incurred by the Parties
in the action from which such Recovery was received on a pro rata basis. Any
Recoveries from actions brought by Novartis or Amgen from and after the
Effective Date during the Term, with respect to Franchise Product 1 or Franchise
Product 2, or from and after the Option Exercise Date, with respect to Franchise
Product 3, that are left over after such reimbursement shall be allocated
between the Parties [*] percent ([*]%) to the Party initiating the action and
[*] percent ([*]%) to the other Party. Amgen shall have the sole right to retain
(i) any and all Recoveries from actions brought by Amgen with respect to
Territory Patents and Trademarks related to Franchise Product 3 prior to the
Option Exercise Date, (ii) any and all recoveries with respect to the
enforcement of any Amgen intellectual property or proprietary right or Joint
Patents outside the Territory and (iii) any and all Recoveries from actions
brought by Amgen after termination of this Agreement.

10.7.
Patent Term Extensions. From and after the Effective Date, with respect to
Territory Patents and Trademarks related to Franchise Product 1 and Franchise
Product 2, and from and after the Option Exercise Date, with respect to
Territory Patents and Trademarks related to Franchise Product 3, each Party
shall provide reasonable assistance to the other Party in connection with
obtaining SPCs for Licensed Amgen Patents in the Territory consistent with the
rights of the other Party to control such matters as specified in Section 10.2
(Prosecution

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and Maintenance). To the extent reasonably and legally required in order to
obtain any such SPC in a particular country, each Party shall make available to
the other a copy of the necessary documentation to enable such other Party to
use the same for the purpose of obtaining the SPC in such country.

10.8.
Employee Agreements. Prior to beginning work relating to any aspect of the
subject matter of this Agreement or being given access to Licensed Amgen
Know-How or Licensed Novartis Know-How or Confidential Information of the other
Party, each employee, consultant or agent of Novartis or Amgen, respectively,
shall have either signed or shall be bound to a non-disclosure and invention
assignment agreement pursuant to which each such person shall agree to comply
with all of the obligations of Novartis or Amgen, as appropriate, substantially
including: (a) promptly reporting any Information, as appropriate; (b) assigning
to Novartis or Amgen, as appropriate, all of his or her right, title and
interest in and to any such Information or be bound by applicable Law to assign
to Novartis or Amgen, as appropriate, all of his or her right, title and
interest in and to any such Information; (c) cooperating in the preparation,
filing, prosecution, maintenance, enforcement and defense of any intellectual
property rights; (d) performing all acts and signing, executing, acknowledging
and delivering any and all papers, documents and instruments required for
effecting the obligations and purposes of this Agreement; and (e) abiding by the
obligations of confidentiality and non-use set forth in this Agreement. It is
understood and agreed that any such non-disclosure and invention assignment
agreement need not be specific to this Agreement, and that the operation of a
collective employment policy sufficient to achieve the intent of the foregoing
shall be sufficient to satisfy such obligation. Each Party shall be responsible
for any compensation and any other payments due to its own inventors of any
patent right.

11.
CONFIDENTIALITY AND PUBLICATIONS

11.1.
Confidentiality; Exceptions. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that, during the
Term and for [*] years thereafter, the receiving Party shall keep confidential
and shall not publish or otherwise disclose or use for any purpose other than as
provided for in this Agreement any confidential and proprietary information and
materials furnished to it by the other Party pursuant to this Agreement
(collectively, “Confidential Information”). Novartis shall have no right to and
shall not utilize any Confidential Information of Amgen for activities outside
the Territory except as required under the applicable Development Plan. Amgen
shall have no right to and shall not utilize any Confidential Information of
Novartis for activities in the Territory except as required under the applicable
Development Plan or for purposes of Manufacturing the Licensed Products. For
clarity, Confidential Information of a Party shall include all information and
materials disclosed by such Party or its designee that (i) is marked as
“Confidential,” “Proprietary” or with similar designation at the time of
disclosure or (ii) by its nature can reasonably be expected to be considered
Confidential Information by the recipient. Information disclosed orally shall
not be required to be identified as such to be considered Confidential
Information. Notwithstanding the foregoing, Confidential Information shall not
include any information to the extent that it can be established by written
documentation by the receiving Party that such information:

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11.1.1.
was already known to the receiving Party, other than under an obligation of
confidentiality (except to the extent such obligation has expired or an
exception is applicable under the relevant agreement pursuant to which such
obligation was established), at the time of disclosure;

11.1.2.
was generally available to the public or otherwise part of the public domain at
the time of its disclosure to the receiving Party;

11.1.3.
became generally available to the public or otherwise part of the public domain
after its disclosure and other than through any act or omission of the receiving
Party in breach of this Agreement;

11.1.4.
was independently developed by the receiving Party (without reference to or use
of Confidential Information of the other Party) as demonstrated by documented
evidence prepared contemporaneously with such independent development; or

11.1.5.
was disclosed to the receiving Party, other than under an obligation of
confidentiality (except to the extent such obligation has expired or an
exception is applicable under the relevant agreement pursuant to which such
obligation was established), by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others.

11.2.
Authorized Disclosure. Except as expressly provided otherwise in this Agreement,
each Party may use and disclose Confidential Information of the other Party
solely as follows: (i) under appropriate confidentiality provisions
substantially equivalent to those in this Agreement: (a) in connection with the
performance of its obligations or as reasonably necessary or useful in the
exercise of its rights under this Agreement, and (b) to the extent such
disclosure is reasonably necessary or useful in conducting Development under
this Agreement; (ii) to the extent such disclosure is to a Governmental
Authority as reasonably necessary in filing or prosecuting patent, copyright and
trademark applications in accordance with this Agreement, prosecuting or
defending litigation in accordance with this Agreement, complying with
applicable governmental regulations with respect to performance under this
Agreement, filing Regulatory Filings, obtaining Regulatory Approval or
fulfilling post-approval regulatory obligations for the Licensed Product, or
otherwise required by Law; provided, however, that if a Party is required by Law
or the rules of any securities exchange or automated quotation system to make
any such disclosure of the other Party’s Confidential Information it shall,
except where impracticable for necessary disclosures (for example, in the event
of medical emergency), give reasonable advance notice to the other Party of such
disclosure requirement and, in the case of each of the foregoing, shall use its
reasonable efforts to secure confidential treatment of such Confidential
Information required to be disclosed; (iii) to advisors (including lawyers and
accountants) on a need to know basis, in each case under appropriate
confidentiality provisions or professional standards of confidentiality
substantially equivalent to those of this Agreement; or (iv) to the extent
mutually agreed to by the Parties. For purposes of clarity, in each case ((i)
through (iv)), Novartis shall ensure that information and materials relating to
the Collaboration are not shared with or used for the benefit of, and are
Segregated from, [*].

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11.3.
Use of Confidential Information and Data with Distracting Programs. Each Party
acknowledges the value of Confidential Information and other data provided by
the other Party hereunder and agrees that it shall not utilize any such
information to benefit its programs or products other than the Licensed Products
or, in the case of Amgen prior to the Option Exercise Date, Franchise Product 3.

11.4.
Terms and Conditions Confidential. Neither Party shall disclose the terms and
conditions of this Agreement except as may be required by Law. Notwithstanding
the foregoing, with respect to complying with the disclosure requirements of any
Governmental Authority in connection with any required filing of this Agreement,
the Parties shall consult with one another concerning which terms of this
Agreement shall be requested to be redacted in any public disclosure of the
Agreement, and in any event each Party shall seek reasonable confidential
treatment for any public disclosure by any such Governmental Authority. Each
Party shall have the right to issue press releases in regards to this Agreement
or any Licensed Product with the prior written agreement of the other Party or
as required to comply with any Law or by the rules of any stock exchange or
automated quotation system (in the case of such required disclosure, by
providing [*] Business Days’ notice to the other Party and reasonably
considering comments provided by such other Party within [*] Business Days after
such notice, or such shorter notice and comment time periods as the disclosing
Party may reasonably require). Notwithstanding the foregoing, the Parties shall
agree upon and each Party shall release a press release to announce the
execution of this Agreement in the applicable form attached hereto as the Press
Release Schedule; thereafter, Novartis and Amgen may each disclose to Third
Parties the information contained in such press release without the need for
further approval by the other Party.

11.5.
Prior Agreement. This Agreement supersedes the Confidential Disclosure Agreement
between the Parties dated [*] and amended on [*], including any written requests
thereunder, (the “Prior Agreement”) with respect to information disclosed
thereunder relating to the Licensed Products and the research and Development
related thereto. All confidential information exchanged between the Parties
under the Prior Agreement shall be deemed Confidential Information of the
disclosing Party and shall be subject to the terms of this Agreement.

11.6.
Publications and Presentations. Amgen and Novartis shall be free to (provided
that, with respect to Franchise Product 3, Novartis shall only have such rights
after the Option Exercise Date):

11.6.1.
present findings with respect to any Licensed Product at symposia and other
meetings of healthcare professionals, and international, national or regional
congresses, conferences or meetings organized by a professional society or
organization (any such occasion, a “Scientific Meeting”); provided, however,
unless otherwise agreed by the Parties, that (i) the Party presenting at any
such Scientific Meeting shall have complied with the provisions of Section 11.6
(Publications and Presentations) and Section 11.7 (Scientific Papers, Abstracts
and Posters) with respect to such presentation, and, with respect to any such
Scientific Meeting at which a Party is presenting, such presenting Party shall
inform the other Party of such Scientific Meeting and where invitation is
required, invite the other Party to attend such

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Scientific Meeting; and (ii) a Party shall not organize or sponsor any satellite
symposia in a country outside its territory without the other Party’s prior
written consent, not to be unreasonably withheld;
11.6.2.
publish in medical and scientific journals and similar publications (“Medical
Journals”) articles and papers, including primary reports of clinical data,
secondary or pooled analyses, and review papers concerning any Licensed Product
which have been prepared by or on behalf of such Party, for publication outside
or in the Territory and related to studies conducted after the Effective Date
outside or in the Territory concerning such Licensed Product (each a “Scientific
Paper”); provided, however, that the Party proposing to publish such Scientific
Paper shall have complied with the provisions of Section 11.7 (Scientific
Papers, Abstracts and Posters) with respect to such Scientific Paper; and

11.6.3.
disclose any clinical data generated by such Party concerning any Licensed
Product in clinical trial registries; provided, however, that the Party
proposing to make such disclosure shall have provided the other Party at least
[*] Business Days prior to such disclosure (to the extent practicable), a
detailed description of the proposed disclosure and shall have, in good faith,
considered the comments made by the other Party.

11.7.
Scientific Papers, Abstracts and Posters.

11.7.1.
Scientific Papers. Each Party through a JPT shall provide to the other, prior to
submission of any Scientific Paper to a Medical Journal, a draft of such
Scientific Paper. Commencing with the receipt of such draft Scientific Paper,
the receiving Party shall have [*] Business Days to notify the sending Party of
its observations and suggestions with respect thereto; it being understood that,
during such [*] Business Day period, no submission for publication thereof shall
take place and the Parties shall discuss these suggestions. The Party proposing
to publish such Scientific Paper shall, in good faith, consider the comments
made by the other Party, particularly if disclosure may be prejudicial to the
other Party’s opportunity to obtain any patent rights. A Party will not publish
or present any Confidential Information of the other Party without such other
Party’s prior written consent. The sending Party shall provide to the receiving
Party copies of any final Scientific Paper accepted by a Medical Journal, not
less than [*] Business Days or as soon as practicable prior to the planned
publication thereof (upon availability and distribution of such information
assuming that providing such information is acceptable taking into consideration
the publishers’ need to comply with any healthcare compliance guidelines). To
enable free exchange of copyrighted material between the Parties, each Party
agrees that it has or shall (i) obtain and maintain, at its own expense, an
Annual Copyright License or equivalent license from the Copyright Clearance
Center and (ii) list the other Party as a collaborator in an agreement with the
Copyright Clearance Center.

11.7.2.
Abstracts and Posters. Each Party shall provide to the other, prior to
submission or presentation, as the case may be, copies of (i) all abstracts that
will be submitted for publication in connection with any international or major
national Scientific Meeting

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in the Territory or outside of the Territory, and (ii) all posters and other
materials (such as slides) that will be presented at such Scientific Meeting, in
each case, concerning a Licensed Product which have been prepared by or on
behalf of one of the Parties, for submission or presentation outside or in the
Territory. Commencing with the receipt of any such abstract or poster or oral
presentation materials the receiving Party shall have [*] Business Days to
inform the sending Party of its observations and suggestions with respect
thereto; it being understood that, during such [*] Business Day period, no
submission or presentation thereof shall take place and the Parties shall
discuss these suggestions. The Party proposing to publish such an abstract or
make such a presentation shall, in good faith, consider the comments made by the
other Party, particularly if disclosure may be prejudicial to the other Party’s
opportunity to obtain any patent rights. A Party will not submit in any abstract
or present in any poster, other written materials or oral presentation any
Confidential Information of the other Party without such other Party’s prior
written consent. The sending Party shall provide to the receiving Party copies
of all final abstracts accepted for publication and all final posters to be
presented [*] Business Days or as soon as practicable prior to the planned
publication or presentation thereof and oral presentations and accompanying
written materials at least [*] Business Days prior to presentation (upon
availability and distribution of such information assuming that providing such
information is acceptable taking into consideration the publishers’ need to
comply with any healthcare compliance guidelines).
Each Party agrees that it will not unreasonably withhold, condition or delay its
consent to requests for (i) extensions of the above timelines (in Sections 11.6
(Publications and Presentations) and 11.7 (Scientific Papers, Abstracts and
Posters)) in the event that material late-breaking clinical data becomes
available or (ii) shortening of the above timelines (in Sections 11.6
(Publications and Presentations) and 11.7 (Scientific Papers, Abstracts and
Posters)) if the requesting Party has a good faith belief that circumstances
warrant such acceleration. The Parties acknowledge and agree that all
publications and presentations pursuant to Sections 11.6 (Publications and
Presentations) and 11.7 (Scientific Papers, Abstracts and Posters) shall comply
with the International Committee of Medical Journal Editors (ICMJE)
Recommendations for the Conduct, Reporting, Editing, and Publication of
Scholarly Work in Medical Journals.

11.8.
Deferral of Disclosures. If either Party believes that any proposed press
release or other public statement, or any publication, presentation, or other
disclosure would be prejudicial to its opportunity to obtain any patent rights,
then the affected Party shall notify the publishing Party within the timeframe
provided for in Section 11.9 (Failure to Object to Disclosure) as applicable, or
if not applicable, as soon as practicable after receipt of the proposed press
release or other public statement, publication, presentation, or other
disclosure, and the publishing Party shall refrain from making such press
release, other public statement, publication, presentation or other disclosure
for an additional [*] days from the last day of the period otherwise provided
for herein to enable the preparation and filing of any necessary patent
applications.

11.9.
Failure to Object to Disclosure. If the Party proposing any press release or
other public statement, or any publication, presentation, or other disclosure
receives no objection from

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the other Party within the timeframes set forth in the corresponding Section,
then, the Party proposing such press release, other public statement,
publication, presentation, or other disclosure shall be free to proceed with the
same without further reference to or agreement from other Party.

11.10.
Attorney-Client Privilege. Neither Party is waiving, nor shall be deemed to have
waived or diminished, any of its attorney work product protections,
attorney-client privileges or similar protections and privileges as a result of
disclosing information pursuant to this Agreement, or any of its Confidential
Information (including Confidential Information related to pending or threatened
litigation) to the receiving Party, regardless of whether the disclosing Party
has asserted, or is or may be entitled to assert, such privileges and
protections. The Parties: (i) share a common legal and commercial interest in
such disclosure that is subject to such privileges and protections; (ii) are or
may become joint defendants in proceedings to which the information covered by
such protections and privileges relates; (iii) intend that such privileges and
protections remain intact should either Party become subject to any actual or
threatened proceeding to which the disclosing Party’s Confidential Information
covered by such protections and privileges relates; and (iv) intend that after
the Effective Date both the receiving Party and the disclosing Party shall have
the right to assert such protections and privileges.

12.
REPRESENTATIONS, WARRANTIES AND COVENANTS

12.1.
Mutual Representations and Warranties. Each of the Parties hereby represents and
warrants to the other Party as follows:

12.1.1.
As of the Effective Date, it is duly organized and validly existing under the
Laws of its jurisdiction of incorporation and it has full corporate power and
authority and has taken all corporate action necessary to enter into and perform
this Agreement;

12.1.2.
As of the Effective Date, this Agreement is a legal and valid obligation binding
upon such Party and enforceable in accordance with its terms; the execution,
delivery and performance of the Agreement by such Party does not conflict with
any agreement, instrument or understanding, oral or written, by which it is
bound, nor to its knowledge as of the Effective Date violate any Law; and the
person or persons executing this Agreement on such Party’s behalf have been duly
authorized to do so by all requisite corporate action;

12.1.3.
To its knowledge, as of the Effective Date no government authorization, consent,
approval, license, exemption of or filing or registration with any court or
Governmental Authority, under Law, is or shall be necessary for, or in
connection with, the entering into of this Agreement or the transaction
contemplated by this Agreement, or (except for EMA or other regulatory
approvals, licenses, clearances and the like necessary for the research,
Development, conduct of Medical Affairs Activities with respect to, Manufacture,
sales or marketing of pharmaceutical products and except for any required filing
with the U.S. Securities and Exchange Commission) for the performance by it of
its obligations under this Agreement;

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12.1.4.
As of the Effective Date, it has not been debarred or excluded or the subject of
debarment or exclusion proceedings by any Governmental Authority;

12.1.5.
To its knowledge, as of the Effective Date it and its Affiliates have not
committed any Material Anti-Corruption Law Violation other than, in the case of
Amgen, the mis-promotion activities preceding the Corporate Integrity Agreement,
entered into between Amgen and the Office of the Inspector General of the
Department of Health and Human Services in December 2012; and

12.1.6.
As of the Effective Date, it has not knowingly used in connection with the
research, Development, conduct of Medical Affairs Activities, Manufacture or
Commercialization to take place pursuant to this Agreement any employee,
consultant or investigator that has been debarred, excluded or disqualified or
the subject of debarment, exclusion or disqualification proceedings by any
Governmental Authority.

12.2.
Amgen Representations and Warranties. Amgen hereby represents that, as of the
Effective Date:

12.2.1.
Amgen has the right to grant the rights granted to Novartis under this
Agreement, and no rights granted to Novartis pursuant to this Agreement are in
violation of any agreement between Amgen or any of its Affiliates and any Third
Party;

12.2.2.
As of the Effective Date, it has sufficient legal and/or beneficial title and
ownership under the Licensed Amgen Patents, Licensed Amgen Trademarks and
Licensed Amgen Know-How (with respect to Amgen) to grant the licenses to the
other Party as purported to be granted pursuant to this Agreement;

12.2.3.
Amgen Controls the Licensed Amgen Patents listed on the Licensed Amgen Patents
Schedule, free of any Liens. The Licensed Amgen Patents in the Territory listed
on the Licensed Amgen Patents Schedule constitute a true and complete list of
all Patents Controlled by Amgen in the Territory relating to the Franchise
Product 1 and Franchise Product 2 in the Territory;

12.2.4.
Amgen has not received any written notice from any Third Party asserting or
alleging that the Development, Manufacture, use or sale of any Licensed Product
infringes rights of such Third Party in the Territory;

12.2.5.
Amgen has not received any written notice of any opposition or challenge against
any Licensed Amgen Patent in the Territory;

12.2.6.
All data and information relating to Franchise Product 1 and Franchise Product 2
filed by Amgen with the EMA are true and accurate in all material respects;

12.2.7.
Amgen has filed with the EMA all [*] relating to Franchise Product 1 and
Franchise Product 2 in Amgen’s possession that are required to be filed, and has
made available to Novartis, all such [*]; and

12.2.8.
Amgen has not received any written notice that any Governmental Authority has
commenced any investigation or any action to withdraw any Regulatory Filing with

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respect to the Development, Manufacture or Commercialization of Franchise
Product 1 or Franchise Product 2, [*].

12.3.
Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 12
(REPRESENTATIONS, WARRANTIES AND COVENANTS), NOVARTIS AND AMGEN EXPRESSLY
DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY
OR OTHERWISE, WITH RESPECT TO THE COLLABORATION, THE LICENSED PRODUCTS, THE
LICENSED AMGEN PATENTS, LICENSED AMGEN TRADEMARKS, LICENSED AMGEN KNOW-HOW,
LICENSED NOVARTIS PATENTS, LICENSED NOVARTIS TRADEMARKS, LICENSED NOVARTIS
KNOW-HOW, THIS AGREEMENT, OR ANY OTHER SUBJECT MATTER RELATING TO THIS
AGREEMENT, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, VALIDITY OR NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS. Except as
set forth in this Article 12 (Representations, Warranties and Covenants), all
licenses by Novartis to Amgen under the Licensed Novartis Know-How and Licensed
Novartis Patents shall be granted “as-is” and all licenses by Amgen to Novartis
under the Licensed Amgen Know-How, Licensed Amgen Trademarks and Licensed Amgen
Patents shall be granted “as-is”.

12.4.
Covenants. Each of the Parties hereby covenants to the other Party as follows:

12.4.1.
It shall not knowingly use in connection with the research, Development, conduct
of Medical Affairs Activities, Manufacture or Commercialization to take place
pursuant to this Agreement any employee, consultant or investigator that has
been debarred, excluded, disqualified or the subject of debarment, exclusion or
disqualification proceedings by any Governmental Authority;

12.4.2.
Each Party agrees, on behalf of itself, its officers, directors and employees
and on behalf of its Affiliates, agents, representatives, consultants and
subcontractors acting for or on behalf of such Party in connection with the
subject matter of this Agreement (together with the Party, the “Party
Representatives”) that in connection with the research, Development, conduct of
Medical Affairs Activities, Manufacture or Commercialization to take place
pursuant to this Agreement:

12.4.2.1.
Each Party’s respective Party Representatives shall not directly or indirectly
pay, offer or promise to pay, or authorize such payment, offer or promise of,
any money or anything else of value, to any Person or Government Official for
the purpose of influencing the acts of such Person or Government Official to
induce them to use their influence with any Governmental Authority, or obtaining
or retaining business or any improper advantage in connection with this
Agreement, or that would otherwise violate any Anti-Corruption Laws.

12.4.2.2.
Each Party’s Party Representatives shall not, directly or indirectly, solicit,
receive or agree to accept any payment of money or anything else of value in
violation of the Anti-Corruption Laws.

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12.4.2.3.
Each Party, on behalf of itself and its other Party Representatives, represents
and warrants to the other Party that for the Term of this Agreement and [*]
years thereafter each Party shall maintain complete and accurate books,
accounts, invoices and reasonably detailed records related to this Agreement or
any work conducted for or on behalf of Amgen under this Agreement including all
records required to establish compliance with Sections 12.4.2.1 and 12.4.2.2
above.

12.4.2.4.
Each Party shall promptly provide the other Party with written notice of the
following events:

(a)
Upon becoming aware of any breach or violation by a Party or its Party
Representative of any representation, warranty or undertaking set forth in
Sections 12.4.2.1 and 12.4.2.2.

(b)
Upon receiving a formal notification that it is the target of a formal
investigation by a Governmental Authority for a Material Anti-Corruption Law
Violation or upon receipt of information from any of its Party Representatives
connected with this Agreement that any of them is the target of a formal
investigation by a Governmental Authority for a Material Anti-Corruption Law
Violation.

12.4.3.
If either Party requests that the other Party complete a compliance
certification certifying compliance with Section 12.4.2.1, which request shall
occur no more than once per Calendar Year, such other Party shall promptly
complete and deliver such compliance certification truthfully and accurately;

12.4.4.
If either Party requests, in connection with a Corporate Integrity Agreement or
similar arrangement with a Governmental Authority, that the other Party complete
a compliance certification certifying adherence to and compliance with such
other Party’s code of conduct and compliance program with respect to such other
Party’s activities under this Agreement, which request shall occur no more than
once per Calendar Year, such other Party shall cooperate with the first Party to
promptly complete and deliver such compliance certification truthfully and
accurately;

12.4.5.
It shall carry out its activities hereunder in compliance with Law (including
relevant Laws relating to economic sanctions, bribery and data protection and
privacy) and shall use Commercially Reasonable Efforts to comply in all material
respects with the International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA) Code of Practice (and implementing regional or national
codes thereof); and

12.4.6.
It shall not grant any right to any Third Party that conflicts with the rights
granted to the other Party hereunder.

13.
LIMITATIONS OF LIABILITY; INSURANCE

13.1.
Limitations of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR

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CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH THIS
AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT,
TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE), EVEN IF SUCH PARTY
WAS ADVISED OR OTHERWISE AWARE OF THE LIKELIHOOD OF SUCH DAMAGES. The
limitations set forth in this Section 13.1 (Limitations of Liability) shall not
apply with respect to (i) either Party’s indemnification obligations under
Article 14 (Indemnification), (ii) 11.1 (Confidentiality; Exceptions) or 11.2
(Authorized Disclosure) or (iii) the gross negligence or willful misconduct of a
Party.

13.2.
Insurance. During the Term and for [*] years thereafter each Party shall obtain
and maintain comprehensive general liability insurance covering its obligations
and activities hereunder, including products liability insurance and coverage
for clinical trials, with reputable and financially secure insurance carriers in
a form and at levels as customary for a company of its size in the
pharmaceutical industry (or reasonable self-insurance sufficient to provide
materially the same level and type of protection). The foregoing requirement may
be satisfied by a program of self-insurance.

14.
INDEMNIFICATION

14.1.
Indemnity.

14.1.1.
By Novartis. Subject to the remainder of this Article 14 (Indemnification)
Novartis shall defend, indemnify, and hold harmless Amgen, its Affiliates, and
their respective directors, officers, employees and agents (solely to the extent
acting within their agency) (collectively, “Amgen Indemnitees”), at Novartis’s
cost and expense, from and against any and all liabilities, losses, costs,
damages, fees or expenses (including reasonable legal expenses and attorneys’
fees incurred by any Amgen Indemnitees until such time as Novartis has
acknowledged and assumed its indemnification obligation hereunder with respect
to a claim) (collectively, “Losses”) arising out of any claim, action, lawsuit,
or other proceeding (collectively, “Claims”) brought against any Amgen
Indemnitee by a Third Party to the extent such Losses result from (i) the gross
negligence or willful misconduct of Novartis, its Affiliates or agents in
performing under this Agreement, (ii) a breach by Novartis of this Agreement,
including any failure of Novartis’s representations or warranties in Section
12.1 (Mutual Representations and Warranties) to be true, or (iii) Novartis’s,
its Affiliate’s or its licensee’s (other than Amgen, its Affiliates or its
licensees) Development or Commercialization of, or conduct of Medical Affairs
Activities with respect to, the Licensed Products other than clinical studies
conducted by Amgen in the Territory but, in each case, excluding such Losses to
the extent they arise from (x), (y) or (z) of Section 14.1.2 (By Amgen) below.

14.1.2.
By Amgen. Subject to the remainder of this Article 14 (Indemnification), Amgen
shall defend, indemnify, and hold harmless Novartis, its Affiliates, and their
respective directors, officers, employees and agents (solely to the extent
acting within their agency) (collectively, “Novartis Indemnitees”), at Amgen’s
cost and expense, from and against any and all Losses (including reasonable
legal expenses and

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attorneys’ fees incurred by any Novartis Indemnitees until such time as Amgen
has acknowledged and assumed its indemnification obligation hereunder with
respect to the applicable Claim) arising out of any Claim brought against any
Novartis Indemnitee by a Third Party to the extent such Losses result from (x)
the gross negligence or willful misconduct of Amgen, or its Affiliates or agents
in performing under this Agreement, (y) a breach by Amgen of this Agreement,
including any failure of Amgen’s representations or warranties in Section 12.1
(Mutual Representations and Warranties) and 12.2 (Amgen Representations and
Warranties) to be true, or (z) Amgen’s, its Affiliate’s or its licensee’s (other
than Novartis, its Affiliates or its licensees) Development or Manufacture of
the Licensed Products prior to the Effective Date, or thereafter, Development,
Manufacture or Commercialization of, or conduct of Medical Affairs Activities
with respect to, the Licensed Product for use or sale outside the Territory or
performance of clinical studies with the Licensed Product in the Territory, but,
in each case, excluding such Losses to the extent they arise from (i), (ii), or
(iii) of Section 14.1.1 (By Novartis) above.
14.1.3.
Supply Agreement. Notwithstanding any other provision of this Agreement, with
respect to any Claim for which a Party would be entitled to be indemnified in
accordance with the terms of this Section 14 (Indemnification) relating to
Manufacturing for which such Party is also entitled to be indemnified in
accordance with a given Supply Agreement, such Party shall only be entitled to
be indemnified pursuant to such Supply Agreement in accordance with the terms
thereof (including any applicable limitations of liability) and this Section
14.1 (Indemnity) shall not apply to such Claim.

14.2.
Claim for Indemnification. Whenever any Claim or Loss shall arise for which a
Novartis Indemnitee or an Amgen Indemnitee (the “Indemnified Party”) may seek
indemnification under this Article 14 (Indemnification), the Indemnified Party
shall promptly notify the other Party (the “Indemnifying Party”) of the Claim or
Loss and, when known, the facts constituting the basis for the Claim; provided,
however, that the failure by an Indemnified Party to give such notice or to
otherwise meet its obligations under this Section 14.2 (Claim for
Indemnification) shall not relieve the Indemnifying Party of its indemnification
obligation under this Agreement except and only to the extent that the
Indemnifying Party is actually prejudiced as a result of such failure. Except as
set forth below in this Section 14.2 (Claim for Indemnification), the
Indemnifying Party shall have exclusive control of the defense and settlement of
all Claims for which it is responsible for indemnification and shall promptly
assume defense thereof at its own expense. The Indemnifying Party shall act
diligently and in good faith with respect to all matters relating to the
settlement or disposition of any Claim as the settlement or disposition relates
to the Indemnified Party and shall cause such defense to be conducted by counsel
reasonably acceptable to the Indemnified Party. The Indemnified Party shall not
settle or compromise such Claim for which it is entitled to indemnification
without the prior written consent of the Indemnifying Party, unless the
Indemnifying Party is in breach of its obligation to defend hereunder. In no
event shall the Indemnifying Party settle any Claim without the prior written
consent of the other Party if such settlement does not include a complete
release from liability on such Claim or if such

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settlement would involve undertaking an obligation other than the payment of
money, would bind or impair the other Party, or includes any admission of
wrongdoing or that any intellectual property or proprietary right of the other
Party is invalid or unenforceable. The Indemnified Party shall reasonably
cooperate with the Indemnifying Party at the Indemnifying Party's expense and
shall make available to the Indemnifying Party reasonably requested information
under the control of the Indemnified Party, which information shall be subject
to Article 11 (Confidentiality and Publications). The Indemnified Party shall
have the right (at its own expense) to be present in person or through counsel
at all legal proceedings giving rise to the right of indemnification.
Notwithstanding the foregoing, the Indemnified Party will have the right to
employ separate counsel at the Indemnifying Party’s expense and to control its
own defense of the applicable Claim if: (i) there are or may be legal defenses
available to the Indemnified Party that are different from or additional to
those available to the Indemnifying Party; or (ii) in the reasonable opinion of
counsel to the Indemnified Party, a conflict or potential conflict exists
between the Indemnified Party and Indemnifying Party that would make such
separate representation advisable; provided that in no event will the
Indemnifying Party be required to pay fees and expenses under this sentence for
more than one (1) firm of attorneys in any jurisdiction in any one (1) legal
action or group of related legal actions. In such event, the Indemnified Party
shall not settle or compromise such Claim without the prior written consent of
the Indemnifying Party, such consent not to be unreasonably withheld,
conditioned or delayed.

15.
TERM AND TERMINATION

15.1.
Term. This Agreement shall come into effect as of the Effective Date and shall
remain in effect during the Term. For the avoidance of doubt, after the expiry
of the Royalty Term with respect to a given Licensed Product in a given country,
the licenses granted by Amgen to Novartis pursuant to this Agreement with
respect to such Licensed Product and Licensed Amgen Trademarks for such Licensed
Product in such country shall become fully paid up, and royalty free and
Novartis shall no longer have any obligations pursuant to this Agreement with
respect to such Licensed Product other than as set forth in Section 15.4
(Additional Surviving Provisions).

15.2.
Termination. This Agreement may be terminated as follows:

15.2.1.
Termination with respect to Franchise Product 3 if Option not Exercised during
Option Period. This Agreement shall immediately and automatically terminate
solely with respect to Franchise Product 3 upon expiration of the Option Period
in the event Novartis has not exercised the Option in accordance with Section
2.1 (Option for Franchise Product 3) prior to such expiration. For purposes of
clarity, upon such termination, Amgen shall be free to conduct research,
Development, Medical Affairs Activities, Manufacturing and Commercialization
activities with respect to Franchise Product 3 within or outside the Territory
at its sole discretion, and this Agreement shall survive and continue in full
force and effect with respect to Franchise Product 1 and Franchise Product 2.

15.2.2.
Termination for Breach. If either Party believes that the other Party is in
material breach of this Agreement, then such Party may deliver notice of such
material breach

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(specifying the nature of the breach in reasonable detail) to the other Party.
If the breaching Party (or its Affiliate) fails to cure such material breach
within [*] days after the receipt of such notice (or [*] days with respect to
any failure to pay amounts due hereunder), then the other Party shall be
permitted to terminate this Agreement by written notice given within [*] days
after the end of such cure period and effective upon delivery; provided,
however, if the breaching Party notifies the other Party within such [*] day
period that it disagrees in good faith with such asserted basis for termination,
this Agreement shall not terminate unless and until the matter has been finally
resolved in accordance with Section 16.3 (Governing Law; Jurisdiction); provided
further that if such dispute relates to payment, the cure period will only apply
with respect to payment of disputed amounts, and not with respect to undisputed
amounts.
15.2.3.
Termination for Insolvency. A Party shall have the right to terminate this
Agreement, upon written notice thereof to the other Party, if the other Party
suffers an Insolvency Event.

15.2.4.
Termination for Challenge. Amgen shall have the right to terminate this
Agreement should Novartis, its Affiliate or its or their licensee under the
Licensed Amgen Patents or Licensed Amgen Trademarks bring or join any challenge
to the validity or enforceability of any Licensed Amgen Patent or Licensed Amgen
Trademark and Novartis, its Affiliate or its or their licensee has not withdrawn
from such challenge within [*] days following receipt of a written notice from
Amgen to withdraw.

15.2.5.
Novartis Termination for Convenience. Novartis shall have the right to terminate
this Agreement, in whole or with respect to a given Licensed Product:

15.2.5.1.
from and after [*] until [*], upon [*] months’ prior written notice to Amgen,
and in the event of such termination, (i) for purposes of clarity, Novartis’s
obligations to fund its share of Development Costs pursuant to Section 9.7
(Development Cost Sharing) and to use Commercially Reasonable Efforts to
Commercialize Licensed Products pursuant to Section 7.1 (Commercially Reasonable
Efforts) shall continue during such [*] notice period, and (ii) Novartis shall
additionally pay to Amgen an amount equal to (a) the amount of Development Costs
borne (whether or not actually paid as of such termination) by Novartis pursuant
to Section 9.7 (Development Cost Sharing) from the Effective Date through the
effective date of such termination, multiplied by (b) [*]; and

15.2.5.2.
from and after [*] months after [*], upon [*] prior written notice to Amgen, and
in the event of such termination, for purposes of clarity Novartis’s obligations
to fund its share of Development Costs pursuant to Section 9.7 (Development Cost
Sharing) and to use Commercially Reasonable Efforts to Commercialize Licensed
Products pursuant to Section 7.1 (Commercially Reasonable Efforts) shall
continue during such [*] month notice period.

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For purposes of clarity, from [*] until [*] thereafter, Novartis shall not have
any right to terminate this Agreement under this Section 15.2.5 (Novartis
Termination for Convenience).

15.3.
Effect of Termination. Termination of this Agreement shall have the following
effects with regard to the Licensed Product:

15.3.1.
General. In the event of any termination of this Agreement, with respect to the
terminated Licensed Products, unless otherwise expressly provided, any
liabilities previously accrued (including the obligation of Novartis to pay
royalties pursuant to Section 9.1 (Royalty Payments) with respect to sales made
prior to the effective date of such termination or, if later, prior to
completion of the transition by Novartis pursuant to Section 15.5 (Transition
Period)) shall survive. In addition, in the event of termination of this
Agreement, each Party shall return to the other Party or destroy (and certify
such destruction to such other Party) all Confidential Information of the other
Party (provided that each Party shall be entitled to retain one (1) copy for
archival and compliance purposes, and as required by applicable Law or
regulatory requirement).

15.3.2.
Termination Effects. In the event of any termination of this Agreement (other
than by Amgen pursuant to Section 7.4 ([*] Divestiture)), with respect to the
applicable terminated Licensed Product(s) (i) Novartis shall use reasonable
efforts to, to the extent permitted by Law and requested by Amgen, assign any
contracts solely to the extent related to the Licensed Products in the Territory
to Amgen or its designee (including by requesting and using good-faith efforts
to obtain any required consents, provided that Novartis shall be under no
obligation to make any payments or incur any liabilities in order to obtain such
consent); (ii) the Parties shall transition responsibility for
Commercialization, Development, Medical Affairs Activities and any other
activities as requested by Amgen with respect to the Licensed Products to Amgen
in accordance with Section 15.5 (Transition Period); (iii) the Parties shall
cooperate to promptly transition sole responsibility for the prosecution,
maintenance and enforcement in the Territory of Territory Patents and Trademarks
to Amgen; (iv) Amgen shall have the right to reacquire some or all of the
inventory of the Licensed Products, as requested by Amgen, in possession of
Novartis and its Affiliates and, if Amgen so reacquires inventory, shall [*];
(v) the Parties shall cooperate to promptly transfer ownership of all Regulatory
Filings and Regulatory Approvals and responsibility for regulatory communication
held by Novartis in the Territory to Amgen, or to terminate or withdraw such
Regulatory Filings and Regulatory Approvals in lieu of transfer (if so requested
by Amgen); (vi) all sublicenses granted by Novartis shall terminate; (vii) Amgen
shall have the right to control all Recalls of the Licensed Products in the
Territory, and in each case Novartis shall provide any reasonable assistance
requested by Amgen in connection therewith; (viii) Section 4.2 (Licensed
Novartis Know-How and Patents) (solely to the extent such intellectual property
has been or is incorporated into or used in the Development, Manufacture,
Medical Affairs Activities, regulatory activities or Commercialization of
Licensed Products as of the date of termination) shall survive; (ix) Amgen shall
have a fully paid, royalty-free [*] right and license to use the Licensed
Novartis Trademarks (and

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the associated goodwill) in connection with Licensed Products in all indications
within the Territory; (x) the Parties shall cooperate to promptly transfer
ownership of all Domain Names and Domain Name registrations related to the
Licensed Products held by Novartis to Amgen; and (xi) at Amgen’s request, the
Parties will discuss in good faith the wind-down or transfer to Amgen of any
ongoing clinical trials for the Licensed Products conducted by or on behalf of
Novartis or its Affiliates; provided that [*] shall bear any expenses incurred
in connection with any such transfer except in the event of termination by [*]
pursuant to [*] or by [*] pursuant to [*]. In the event that the Parties are not
permitted to transfer Regulatory Filings or Regulatory Approvals under clause
(v) above pursuant to Law, the Parties shall cooperate to establish a right of
access and reference to such filings and approvals for Amgen, and Novartis shall
maintain such filings and approvals, and take any actions reasonably requested
by Amgen with respect thereto, and thereafter Novartis shall transfer ownership
of all such Regulatory Filings and Regulatory Approvals to Amgen or its designee
as and when it becomes permissible to do so. [*] In the event of any termination
of this Agreement by Amgen pursuant to Section 7.4 ([*] Divestiture), (a) the
licenses granted to Novartis under Section 4.1 (Licensed Amgen Patents and
Know-How) and under Section 4.5.1 (Grant to Novartis) (solely to the extent such
intellectual property has been or is incorporated into or used in the
Development, Medical Affairs Activities, regulatory activities or
Commercialization of Licensed Products as of the date of termination) shall
survive, (b) Amgen shall continue to Manufacture and supply Licensed Product for
a period of up to [*] months in accordance with the Supply Agreement, (c) the
Royalty Rates shall [*] provided that in no event shall the royalties payable to
Amgen for Franchise Product 1 [*] and for each of Franchise Product 2 and
Franchise Product 3 [*], and (d) the Parties shall negotiate in good faith a
process for the transition of ongoing activities necessary to allow Novartis to
exercise its rights under such license and allow Novartis to continue to
Develop, Manufacture and Commercialize the Licensed Product in the Territory,
including assistance from Amgen for the transfer of Manufacturing to a contract
manufacturing organization mutually agreed by the Parties.

15.4.
Additional Surviving Provisions. In addition and without prejudice to the
provisions of Section 15.3 (Effect of Termination) and the provisions that are
expressly stated to survive termination, in the event of any termination of this
Agreement the following provisions shall survive: Articles 11 (Confidentiality
and Publications) (except with respect to Section 11.6 (Publications and
Presentations), 11.7 (Scientific Papers; Abstracts and Posters), 11.8 (Deferral
of Disclosures) and 11.9 (Failure to Object to Disclosure)); 13 (Limitations of
Liability; Insurance); 14 (Indemnification); 15 (Term and Termination) and 16
(Miscellaneous); 9.1 (Royalty Payments) through 9.6 (No Wrongful Reductions)
(inclusive) (with respect to sales made prior to such termination or, if later,
prior to completion of the transition by Novartis pursuant to Section 15.5
(Transition Period)); 9.7 (Development Cost Sharing) (with respect to
Development Costs reasonably incurred prior to such termination); 9.8
(Sublicense Payments) (with respect to amounts incurred prior to such
termination); 9.10 (Payment Method) through 9.16 (Late Payment) (inclusive);
10.1 (Ownership and

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Cooperation); 10.6 (Allocation of Recoveries) (with respect to periods prior to
termination); and 12.3 (Disclaimer of Warranties).

15.5.
Transition Period. In the event of any termination of this Agreement by Novartis
pursuant to Section [*] or by Amgen pursuant to Section [*], then upon Amgen’s
reasonable request, during the [*] month period following provision of notice of
termination (or, in each case, for such shorter period as Amgen shall reasonably
request) (the “Transition Period”), the Parties shall cooperate to transition
the Development (including any ongoing trials, to the extent permitted by Law)
and Commercialization of, regulatory responsibility for, and conduct of Medical
Affairs Activities with respect to, the Licensed Products in the Field in the
Territory from Novartis to Amgen. Novartis shall take all actions reasonably
requested by Amgen to facilitate such transition, and the Parties shall conduct
such transition expeditiously and as reasonably necessary to minimize disruption
in the Development and Commercialization of, and Medical Affairs Activities with
respect to, the Licensed Products in the Territory. Subject to Section 15.3.2
(Termination Effects), the Parties shall each be responsible for their own costs
incurred in accordance with this Section 15.5 (Transition Period).

16.
MISCELLANEOUS

16.1.
Affiliates. Each Party shall have the right to exercise its rights and perform
its obligations hereunder through its Affiliates (including by licensing rights
hereunder where such rights are held in the name of any such Affiliate),
provided that such Party shall be responsible for its Affiliates’ performance
hereunder.

16.2.
Assignment. Neither this Agreement nor any rights or obligations hereunder may
be assigned or otherwise transferred (whether by operation of Law, general
succession or otherwise) by either Party without the prior written consent of
the other Party. Notwithstanding the foregoing, either Party may assign this
Agreement and its rights and obligations hereunder without prior written consent
to any Affiliate or, with prior notice, in connection with the transfer or sale
to a Third Party of all or substantially all of the business of [*]. Any
assignment not in accordance with this Agreement shall be void ab initio.
Subject to the foregoing, the rights and obligations of the Parties under this
Agreement shall be binding upon and inure to the benefit of the successors and
permitted assigns of the Parties.

16.3.
Governing Law; Jurisdiction. This Agreement shall be governed by, and enforced
and construed in accordance with, the laws of the State of New York without
regard to its conflicts of law provisions, except as to any issue which depends
upon the validity, scope or enforceability of any Patent, which issue will be
determined in accordance with the laws of the country in which such patent was
issued. Each of the Parties hereby irrevocably and unconditionally consents to
submit to the exclusive jurisdiction of the state and federal courts of the
State of New York for any matter arising out of or relating to this Agreement
and the transactions contemplated hereby, and agrees not to commence any
litigation relating thereto except in such courts. Each of the Parties hereby
irrevocably and unconditionally waives any objection to the laying of venue of
any matter arising out of this Agreement or the transactions contemplated hereby
in the state and federal courts of the State of New York and hereby further
irrevocably and unconditionally waives and agrees not to plead or claim

Amgen Ref. No. 2015641252        Page 65

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

in any such court that any such matter brought in any such court has been
brought in an inconvenient forum. The Parties agree that a final judgment in any
such matter will be conclusive and may be enforced in other jurisdictions by
suits on the judgment or in any other manner provided by law. Any proceeding
brought by either Party under this Agreement will be exclusively conducted in
the English language. The United Nations Convention for the International Sale
of Goods will not apply to the transactions contemplated herein.

16.4.
Construction. The definitions of the terms herein shall apply equally to the
singular and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms. The words “include”, “includes” and “including” shall be deemed to
be followed by the phrase “without limitation”. The word “or” is used in the
inclusive sense (and/or). The word “will” shall be construed to have the same
meaning and effect as the word “shall”. The Parties each acknowledge that they
have had the advice of counsel with respect to this Agreement, that this
Agreement has been jointly drafted, and that no rule of strict construction
shall be applied in the interpretation hereof. Unless the context requires
otherwise, (i) any definition of or reference to any agreement, instrument or
other document herein shall be construed as referring to such agreement,
instrument or other document as from time to time amended, supplemented or
otherwise modified (subject to any restrictions on such amendments, supplements
or modifications set forth herein or therein), (ii) any reference to any Laws
herein shall be construed as referring to such Laws as from time to time
enacted, repealed or amended, (iii) any reference herein to any person shall be
construed to include the person’s permitted successors and assigns, (iv) the
words “herein”, “hereof” and “hereunder”, and words of similar import, shall be
construed to refer to this Agreement in its entirety and not to any particular
provision hereof, and (v) all references herein to Articles, Sections, Schedules
or Exhibits, unless otherwise specifically provided, shall be construed to refer
to Articles, Sections, Schedules or Exhibits of this Agreement. This Agreement
has been executed in English, and the English version of this Agreement shall
control.

16.5.
Counterparts. This Agreement may be executed in counterparts with the same
effect as if both Parties had signed the same document. All such counterparts
shall be deemed an original, shall be construed together and shall constitute
one and the same instrument. Signature pages of this Agreement may be exchanged
by facsimile or other electronic means without affecting the validity thereof.

16.6.
[Reserved].

16.7.
Entire Agreement. This Agreement, including the attached Appendices, Schedules
and Exhibits constitutes the entire agreement between the Parties as to the
subject matter of this Agreement, and supersedes and merges all prior
negotiations, representations, agreements and understandings regarding the same.

16.8.
Force Majeure. Neither Party shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay or failure is due
to causes beyond its reasonable control, including acts of God, fires, floods,
earthquakes, labor strikes, acts of war, terrorism or civil unrest (“Force
Majeure”); provided, however, that the affected Party promptly notifies the
other Party in writing (and continues to provide monthly status updates to the
other Party for the duration of the effect); and further provided that the
affected Party shall

Amgen Ref. No. 2015641252        Page 66

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

use its commercially reasonable efforts to avoid or remove such causes of
non-performance and to mitigate the effect of such occurrence, and shall
continue performance with reasonable dispatch whenever such causes are removed.

16.9.
Further Assurances. Each Party agrees to do and perform all such further acts
and things and shall execute and deliver such other agreements, certificates,
instruments and documents necessary or that the other Party may reasonably
request in order to carry out the intent and accomplish the purposes of this
Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

16.10.
Headings. Headings and captions are for convenience only and are not to be used
in the interpretation of this Agreement.

16.11.
No Set-Off. Except as expressly set forth in this Agreement, no Party shall have
the right to deduct from amounts otherwise payable hereunder any amounts payable
to such Party (or its Affiliates) from the other Party (or its Affiliates).

16.12.
Notices. Any notice required or permitted to be given by this Agreement shall be
in writing, in English, and shall be delivered by hand or overnight courier with
tracking capabilities or mailed postage prepaid by registered or certified mail
addressed as set forth below unless changed by notice so given:

If to Amgen:
Amgen Inc.
One Amgen Center Drive

Thousand Oaks, California 91320-1799
Attention: [*]
Telephone: [*]
Facsimile: [*]

If to Novartis:
Novartis Pharma AG

Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: [*]    
Facsimile: [*]    

With a copy to:
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: [*]
Facsimile: [*]    

Any such notice shall be deemed given on the date delivered. A Party may add,
delete (so long as at least one person is remaining), or change the person or
address to which notices

Amgen Ref. No. 2015641252        Page 67

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

should be sent at any time upon written notice delivered to the other Party in
accordance with this Section 16.12 (Notices).

16.13.
Relationship of the Parties. Each Party is an independent contractor under this
Agreement. Nothing contained herein is intended or is to be construed so as to
constitute Novartis and Amgen as partners, agents or joint venturers. Neither
Party shall have any express or implied right or authority to assume or create
any obligations on behalf of or in the name of the other Party or to bind the
other Party to any contract, agreement or undertaking with any Third Party.

16.14.
Severability. If any one or more of the provisions of this Agreement is held to
be invalid or unenforceable, the provision shall be considered severed from this
Agreement and shall not serve to invalidate any remaining provisions hereof. The
Parties shall negotiate in good faith 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.

16.15.
Third Party Beneficiaries. Except as expressly provided with respect to Amgen
Indemnitees or Novartis Indemnities in Article 14 (Indemnification), there are
no third party beneficiaries intended hereunder and no Third Party shall have
any right or obligation hereunder.

16.16.
Waivers and Modifications. The failure of any Party to insist on the performance
of any obligation hereunder shall not be deemed to be a waiver of such
obligation. Waiver of any breach of any provision hereof shall not be deemed to
be a waiver of any other breach of such provision or any other provision on such
occasion or any other occasion. No waiver, modification, release or amendment of
any right or obligation under or provision of this Agreement shall be valid or
effective unless in writing and signed by all Parties hereto.

*********
(Signature page follows)

IN WITNESS WHEREOF, the Parties have executed this Exclusive License and
Collaboration Agreement as of the Effective Date.

Amgen Ref. No. 2015641252        Page 68

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

NOVARTIS PHARMA AG
 
AMGEN INC.
By:
/s/ Corinne Savill
 
By:
/s/ Robert A. Bradway
Name:
Corinne Savill
 
Name:
Robert A. Bradway
Title:
Novartis Pharma AG Head Business Development & Licensing
Forum 2-6.04
4002 Basel
 
Title:
Chairman and Chief Executive
Officer
 
 
 
 
 
By: /s/ Barbara Levi Mager
 
 
Name: Barbara Levi Mager
 
 
Title: Global Legal Head, GPS&C
 
 
 
 
 

Amgen Ref. No. 2015641252        

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

Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Schedule
Clinical Supply
•
Terms and descriptions outlined below, together with any terms contained or
described in the Agreement, will serve as the basis for a definitive Supply
Agreement and Quality Agreement between the Parties.

Term
Description
Stage Supplied
Amgen will supply Novartis with Franchise Product 1 in [*] form in accordance
with the provisions of the Supply Agreement. The Parties shall determine whether
to supply Franchise Product 1 in [*] form based on whether [*]. Additionally,
Amgen will supply Novartis with placebo of Franchise Product 1.
Specifications
Amgen will Manufacture and supply one distinct Franchise Product 1 fulfilling
one set of specifications. However, the Franchise Product 1 specifications may
need to be revised in accordance with requests from the local health authorities
(including with respect to testing methods) on a country-by-country basis.
Novartis will not agree to commitments with a local health authority with
respect thereto without the prior written consent of Amgen.
Remaining Shelf Life
The minimum shelf life remaining upon delivery for use in a particular country
shall be equal to [*]% of the then current approved shelf life of the Franchise
Product 1 in such country (provided that the then current approved shelf life in
such country is a minimum of [*] months). If the then current approved shelf
life of the Franchise Product 1 in such country is less than [*] months, the
Parties shall, through a governance body established under the Supply Agreement,
negotiate in good faith a new minimum shelf life taking into account
Governmental Authority requirements and existing tender constraints.
IncoTerm
Franchise Product 1 will be supplied to Novartis [*] (Incoterms 2010 ICC). Risk
and title to the Franchise Product 1 shall transfer at [*].
Cost
Franchise Product 1 will be supplied to Novartis at [*] (such terms to be
defined in the Supply Agreement in a manner substantially similar as defined in
that certain [*] effective as of [*].

In addition thereto, Amgen will be entitled to charge Novartis certain support
costs directly related to the Manufacture or supply of Franchise Product 1 for
the Territory that are not included in [*] (“Support Costs”) ([*]). The
mechanism for discussing, tracking and charging for Support Costs to be more
fully detailed in the Supply Agreement. The Supply Agreement shall [*] to be
defined in the Supply Agreement.
Site of Manufacture
Amgen has sole discretion to determine which Amgen site will be utilized for
Manufacturing drug substance and drug product for the Franchise Product 1, [*].
[*]. [*]. At any time, Amgen can use a Third Party CMO, [*], provided that [*].
Audit Right
Novartis will have the right to inspect Amgen’s sites utilized for
Manufacturing, [*] storage, testing, shipping or receiving of the Franchise
Product 1 [*] per twelve (12) month period, as well as more often in case of
quality issue.

Amgen Ref. No. 2015641252        SCHEDULE

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Term
Description
Official Inspection
Amgen will permit, and cause its Third Party CMO to permit, officials of any
Regulatory Authority to inspect the Manufacturing facility utilized for
Manufacturing drug substance and drug product for the Franchise Product 1, and
will inform Novartis promptly of any planned or anticipated inspection.

Amgen will permit, and cause its Third Party CMO to permit, Novartis to
accompany such official inspection. Amgen will provide Novartis with copies of
all reports and communications with the Regulatory Authority in connection
therewith, will take into account Novartis’s comments before responding to such
communications and will remedy any deficiencies at its own expense (provided,
however, that Amgen shall be permitted to include certain of such expenses in
its [*] cost of Manufacturing of Franchise Product 1).
Orders and Quantities
The Supply Agreement will include provisions relating to forecasting, including
frequency and length of forecasting, minimum order quantities, binding periods,
variances, and long-range planning.
Variation Management
The Supply Agreement will include provisions relating to variation management,
including notification requirements, whether or not such variation is required
by Governmental Authorities, or requires Governmental Authority approval.
Indemnification
Each Party (the “Indemnifying Party”) will indemnify the other Party for losses
for any claim brought by a Third Party against the other Party to the extent
such losses result from (i) the gross negligence or willful misconduct of the
Indemnifying Party in performing under the Supply Agreement or the Quality
Agreement or (ii) the breach by the Indemnifying Party of its obligations under
the Supply Agreement. Amgen will indemnify Novartis for losses for any claim
brought by a Third Party against Novartis to the extent such losses result from
any manufacturing defect at the time of delivery of Franchise Product 1 to
Novartis (including failure of product to be manufactured in accordance with
cGMP), except in the case that the Amgen reasonably requests Novartis to take
prompt mitigating actions (including conducting a recall) with respect to such
Franchise Product 1, in which case (1) Amgen shall be responsible for the costs
related to such mitigation actions and (2) Novartis shall be responsible for
losses with respect to such Franchise Product 1 for which Novartis declines to
take such requested actions to the extent that such losses result from Novartis’
refusal to implement such requested actions.
Miscellaneous
The Supply Agreement would contain other customary provisions including, without
limitation, provisions regarding financial audit rights, shelf life extension
process, confidentiality, warranties, and termination.
Franchise Product 2 and Franchise Product 3
The terms and conditions set out in this Clinical Supply Schedule shall only
serve as a basis for the Supply Agreement for the Franchise Product 1.

The Supply Agreements for the Franchise Product 2 and the Franchise Product 3,
if any, shall include terms and conditions substantially similar to those set
out in this Clinical Supply Schedule.

Amgen Ref. No. 2015641252        SCHEDULE

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Schedule
Commercial Supply
•
Terms and descriptions outlined below, together with any terms contained or
described in the Agreement, will serve as the basis for a definitive Supply
Agreement and Quality Agreement between the Parties.

Term
Description
Stage Supplied
Amgen will supply Novartis with Franchise Product 1 in accordance with an
available SKU schedule in [*] in accordance with the provisions of the Supply
Agreement. Amgen will have the right to transition the [*] to Novartis on a
region-by-region basis and subject to a mutually agreed upon (i) notice and
transfer period, (ii) transfer plan and (iii) transfer costs. Amgen shall
consider in good faith requests from Novartis to transition [*] on a
region-by-region basis.
Remaining Shelf Life
The minimum shelf life remaining upon delivery for use in a particular country
shall be equal to [*]% of the then current approved shelf life of the Franchise
Product 1 in such country (provided that the then current approved shelf life in
such country is a minimum of [*] months). If the then current approved shelf
life of the Franchise Product 1 in such country is less than [*] months, the
Parties shall, through a governance body established under the Supply Agreement,
negotiate in good faith a new minimum shelf life taking into account
Governmental Authority requirements and existing tender constraints.
IncoTerm
Franchise Product 1 will be supplied to Novartis [*] (Incoterms 2010 ICC). Risk
and title to the Franchise Product 1 shall transfer at [*].
Cost
Subject to [*], Franchise Product 1 will be supplied to Novartis at [*] (the
“Supply Price”).
In addition thereto, Amgen will be entitled to charge Novartis certain support
costs directly related to the Manufacture or supply of Franchise Product 1 for
the Territory that are not included in [*] (“Support Costs”) ([*]). The
mechanism for discussing, tracking and charging for Support Costs to be more
fully detailed in the Supply Agreement. The Supply Agreement shall [*] to be
defined in the Supply Agreement.

Amgen Ref. No. 2015641252        SCHEDULE

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

Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Term
Description
[*]
Notwithstanding anything to be contained in the Supply Agreement to the
contrary, [*].
[*]
[*]
[*]
[*]
[*]
 
 
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
Site of Manufacture
Amgen has sole discretion to determine which Amgen site will be utilized for
Manufacturing drug substance and drug product for the Franchise Product 1, [*].
[*]. [*]. At any time, Amgen can use a Third Party CMO, [*] provided that [*].
Audit Right
Novartis will have the right to inspect Amgen’s sites utilized for
Manufacturing, [*] storage, testing, shipping or receiving of the Franchise
Product 1 [*] per twelve (12) month period, as well as more often in case of
quality issue. No such audit of any commercial Manufacturing facility shall
occur until after [*] at such facility for the applicable Franchise Product 1.
Official Inspection
Amgen will permit, and cause its Third Party CMO to permit, officials of any
Regulatory Authority to inspect the Manufacturing facility utilized for
Manufacturing drug substance and drug product for the Franchise Product 1, and
will inform Novartis promptly of any planned or anticipated inspection.
Amgen will permit, and cause its Third Party CMO to permit, Novartis to
accompany such official inspection. Amgen will provide Novartis with copies of
all reports and communications with the Regulatory Authority in connection
therewith, will take into account Novartis’s comments before responding to such
communications and will remedy any deficiencies at its own expense (provided,
however, that Amgen shall be permitted to include certain of such expenses in
[*] of Franchise Product 1).
Orders and Quantities
The Supply Agreement will include provisions relating to forecasting, including
frequency and length of forecasting, minimum order quantities, binding periods,
variances, and long-range planning.

Amgen Ref. No. 2015641252        SCHEDULE

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

Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Term
Description
Variation Management
The Supply Agreement will include provisions relating to variation management,
including notification requirements, whether or not such variation is required
by Governmental Authorities, or requires Governmental Authority approval.
Indemnification
Each Party (the “Indemnifying Party”) will indemnify the other Party for losses
for any claim brought by a Third Party against the other Party to the extent
such losses result from (i) the gross negligence or willful misconduct of the
Indemnifying Party in performing under the Supply Agreement or the Quality
Agreement or (ii) the breach by the Indemnifying Party of its obligations under
the Supply Agreement. Amgen will indemnify Novartis for losses for any claim
brought by a Third Party against Novartis to the extent such losses result from
any manufacturing defect at the time of delivery of Franchise Product 1 to
Novartis (including failure of product to be manufactured in accordance with
cGMP), except in the case that the Amgen reasonably requests Novartis to take
prompt mitigating actions (including conducting a recall) with respect to such
Franchise Product 1, in which case (1) Amgen shall be responsible for the costs
related to such mitigation actions and (2) Novartis shall be responsible for
losses with respect to such Franchise Product 1 for which Novartis declines to
take such requested actions to the extent that such losses result from Novartis’
refusal to implement such requested actions.
Distribution
Novartis will require its distributors to have appropriate controls in place to
manage the Franchise Product 1 in accordance with product labeled conditions.
Miscellaneous
The Supply Agreement would contain other customary provisions including, without
limitation, provisions regarding financial audit rights, confidentiality,
warranties, and termination.
Franchise Product 2 and Franchise Product 3
The terms and conditions set out in this Commercial Supply Schedule shall only
serve as a basis for the Supply Agreement for the Franchise Product 1.

The Supply Agreements for the Franchise Product 2 and the Franchise Product 3,
if any, shall include terms and conditions substantially similar to those set
out in this Commercial Supply Schedule.

Amgen Ref. No. 2015641252        SCHEDULE

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Schedule
Licensed Amgen Patents

Country
Application No.
Filing Date
Title
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]

Amgen Ref. No. 2015641252        SCHEDULE

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Country
Application No.
Filing Date
Title
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]

Amgen Ref. No. 2015641252        SCHEDULE

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Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

Schedule
Out-of-Pocket Development Expenses
Out-of-Pocket Development Expenses, with respect to a Licensed Product, include
direct out-of-pocket costs that are attributable to the Development of the
Licensed Product including:
1.
Toxicology and pharmacokinetics studies;

2.
Clinical studies, including all activities associated with starting,
maintaining, and closing studies;

3.
Clinical materials [*];

4.
Consultants and temporaries used to obtain, maintain, or expand the Development
of the Licensed Products for market approval;

5.
Regulatory fees;

6.
Costs associated with [*] Development activities relating to the Licensed
Products, including [*];

7.
[*] Development, [*] and ongoing [*] activities;

8.
Costs to prepare, submit, or Develop data or information for submission to a
Governmental Authority to obtain, maintain, or expand marketing approval of the
Licensed Products (pre- or post-launch);

9.
Costs associated with any [*] in support of [*] activities such as [*];

10.
Payments to Third Parties for the performance of any Development activities with
respect to the Development of the Licensed Products; and

11.
[*] costs associated with Regulatory Filings. These costs include [*].

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Schedule
Press Release

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amgenlogoa06.jpg [amgenlogoa06.jpg]
News Release

AMGEN ENTERS INTO NEUROSCIENCE COLLABORATION
WITH NOVARTIS FOR ALZHEIMER’S DISEASE AND
MIGRAINE PROGRAMS

Global Co-Development and Co-Commercialization Agreement in Alzheimer's Disease
With Novartis’ Phase 1/2a BACE Inhibitor as the Lead

Preventative Treatment Approach Directed at Genetically Predisposed Individuals
at Risk of Developing Alzheimer’s Disease; Builds on Amgen’s Genetic Validation
Strategy

Global Co-Development Agreement More Rapidly Advances Amgen’s Migraine Programs,
Including AMG 334 in Phase 3

Amgen Retains Migraine Commercialization Rights in the U.S., Japan and Canada;
Provides Novartis With Rights to Commercialize Migraine Programs in Europe and
Rest of World; Leverages Novartis’ Strong Commercial Neuroscience Presence

THOUSAND OAKS, Calif., Sept. 1, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced a neuroscience collaboration with Novartis in the areas of Alzheimer's
disease and migraine. The collaboration accelerates Amgen's potential entry into
Alzheimer's disease by teaming up with Novartis on a differentiated and
genetically validated Alzheimer's disease program directed at genetically
predisposed individuals at risk of developing Alzheimer's disease. The
collaboration also enables Amgen to focus on the commercialization of its
migraine programs in the U.S., Canada and Japan, while
leveraging Novartis' strong commercial capabilities in neuroscience
throughout Europe and other markets worldwide.
The agreement combines each company's BACE (beta-site APP-cleaving enzyme-1)
programs targeting Alzheimer's disease into a global co-commercialization and
co-development arrangement. Novartis' Phase 1/2a BACE inhibitor (CNP520) will be
the lead molecule and each company's pre-clinical BACE inhibitor programs will
be potential follow-ons. Amgen will make upfront and milestone payments, and
will be responsible for

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disproportional research and development (R&D) costs for an agreed-upon period
followed by a 50/50 cost and profit share arrangement. CNP520 is planned to be
included in a pioneering prevention study, in collaboration with the Banner
Alzheimer's Institute. Amgen was the first company to clone the BACE gene and
subsequent genetic validation of the BACE target has been confirmed
by Amgen subsidiary deCODE Genetics.
As part of the collaboration, Novartis receives global co-development rights and
commercial rights outside of the U.S., Canada and Japan to the investigative
molecules in Amgen's migraine portfolio program. This includes AMG 334 in Phase
3 and AMG 301 in Phase 1, as well as an option to commercialize an additional
early-stage Amgen molecule in these territories. In exchange for territory
rights, Novartis will fund disproportional amounts of global R&D expenses for an
agreed-upon period on the migraine programs and pay Amgen double-digit royalties
on sales.
"We are very pleased to be joining forces with Novartis on two important
neuroscience programs where there remains high unmet medical need," said Sean E.
Harper, M.D., executive vice president of Research and Development at Amgen.
"Our collaboration on BACE inhibition reflects Amgen's strategic focus on
genetically validated drug candidates while our collaboration in migraine
creates an opportunity to more rapidly advance AMG 334 on a global scale."
About CNP520
Novartis' CNP520 is an oral drug designed to prevent the production of different
forms of amyloid and has the potential to prevent, slow or delay the symptoms
associated with Alzheimer's disease. It is currently in Phase 1/2a trials.
About Amgen's BACE Research 
BACE (beta-site APP-cleaving enzyme-1) initiates the production of beta amyloid
(Ab), the primary constituent of amyloid plaques that are believed to play a key
role in the etiology of Alzheimer's disease. It is hypothesized that inhibiting
BACE could reduce the production of amyloid plaques. Amgen was the first to
clone and characterize BACE in a 1999 Science publication.1 Amgen subsidiary
deCODE Genetics subsequently added corroborating human genetic evidence of its
link to Alzheimer's disease in a 2012 Nature publication.2 Amgen has a number of
preclinical candidates targeting BACE inhibition.
About Novartis' Collaboration with the Banner Alzheimer's Institute  

In collaboration with the Banner Alzheimer's Institute (BAI), Novartis is
conducting a pioneering prevention study. The study with BAI is part of a
ground-breaking research program known as the Alzheimer's Prevention Initiative
and will involve more than 1,300 cognitively healthy adults, ages 60 to 75, with
a genetic risk of developing symptoms of Alzheimer's disease because they
inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele –
one from each parent. About 2 percent of the world's population has this genetic
profile, which is strongly linked to late-onset Alzheimer's disease. One in four
people carries one copy of the APOE4 gene. Participants in the study will be
given either CNP520, CAD106 (not included in the collaboration with Amgen), or
placebo. Pending regulatory approval, the study is planned to start in late
2015/early 2016 in sites in North America and Europe.
About Alzheimer's Disease
Alzheimer's disease, the most common type of dementia, is a progressive
neurodegenerative disease that begins with microscopic changes in the brain.
Alzheimer's disease causes problems with memory, thinking and behavior. Symptoms
of the disease develop slowly and worsen over time. Two important components

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of Alzheimer's disease are amyloid plaques and inflammation, the combination of
which is believed to lead to a loss of synapses and neuronal death. The disease
continuum can span decades with the initial amyloid accumulation occurring many
years before the first signs of memory loss appear. It is estimated that
approximately 44 million people globally have Alzheimer's disease or a related
dementia.3 The global direct costs of Alzheimer's disease are estimated to be
more than $600 billion.4 

About AMG 334 
AMG 334 is a fully human monoclonal antibody under investigation for the
prevention of migraine. AMG 334 targets the calcitonin gene-related peptide
(CGRP) receptor, which is believed to transmit signals that can cause
incapacitating pain. AMG 334 is currently under evaluation in several large
global, randomized, double-blind, placebo-controlled studies to evaluate its
safety and efficacy in migraine prevention.

About AMG 301
AMG 301 is a monoclonal antibody being investigated for the treatment of
migraine.

About Migraine
Migraine has been declared one of the top 10 most disabling conditions in the
world, with more than 10 percent of the worldwide population suffering from the
condition.5More complex than just a headache, migraines involve incapacitating
head pain and physical impairment, frequently accompanied by nausea, vomiting,
and aura-related sound or other sensory disturbances.6 Migraine also has a
tremendous impact on patients' everyday lives, including work productivity and
social interactions.7,8 More than half of people living with migraine will go
undiagnosed.9 
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering
from serious illnesses by discovering, developing, manufacturing and delivering
innovative human therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and understand the
fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics
manufacturing expertise to strive for solutions that improve health outcomes and
dramatically improve people's lives. A biotechnology pioneer since
1980, Amgen has grown to be one of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is developing a
pipeline of medicines with breakaway potential. 
For more information, visit www.amgen.com and follow us
on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the
current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and
are subject to a number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those described. All statements, other
than statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues, operating margins,
capital expenditures, cash, other financial metrics, expected legal,
arbitration, political, regulatory or clinical results or practices, customer
and prescriber patterns or practices, reimbursement activities and outcomes and
other such estimates and results. Forward-looking statements involve significant
risks and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission (SEC) reports filed by Amgen
Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any
subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen
Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to Amgen's business. Unless otherwise
noted, Amgen is providing this

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information as of Sept. 1, 2015, and expressly disclaims any duty to update
information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ
materially from those Amgen projects. Discovery or identification of new product
candidates or development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate or development
of a new indication for an existing product will be successful and become a
commercial product. Further, preclinical results do not guarantee safe and
effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for Amgen and its partners to complete clinical trials and obtain
regulatory approval for product marketing has in the past varied
and Amgen expects similar variability in the future. Amgen develops product
candidates internally and through licensing collaborations, partnerships and
joint ventures. Product candidates that are derived from relationships may be
subject to disputes between the parties or may prove to be not as effective or
as safe as Amgen may have believed at the time of entering into such
relationship. Also, Amgen or others could identify safety, side effects or
manufacturing problems with Amgen's products after they are on the
market. Amgen's business may be impacted by government investigations,
litigation and product liability claims. If Amgen fails to meet the compliance
obligations in the corporate integrity agreement between Amgen and the U.S.
government, Amgen could become subject to significant sanctions. Amgen depends
on third parties for a significant portion of its manufacturing capacity for the
supply of certain of its current and future products and limits on supply may
constrain sales of certain of its current products and product candidate
development.
In addition, sales of Amgen's products are affected by the reimbursement
policies imposed by third-party payers, including governments, private insurance
plans and managed care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward managed care
and healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others' regulations and
reimbursement policies may affect the development, usage and pricing
of Amgen's products. In addition, Amgen competes with other companies with
respect to some of its marketed products as well as for the discovery and
development of new products. Amgen believes that some of its newer products,
product candidates or new indications for existing products, may face
competition when and as they are approved and marketed. Amgen's products may
compete against products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are otherwise
competitive with its products. In addition, while Amgen and its partners
routinely obtain patents for their products and technology, the protection
of Amgen's products offered by patents and patent applications may be
challenged, invalidated or circumvented by its competitors and there can be no
guarantee of Amgen's or its partners' ability to obtain or maintain patent
protection for Amgen's products or product candidates. Amgen cannot guarantee
that it will be able to produce commercially successful products or maintain the
commercial success of its existing products. Amgen's stock price may be affected
by actual or perceived market opportunity, competitive position and success or
failure of its products or product candidates. Further, the discovery of
significant problems with a product similar to one of Amgen's products that
implicate an entire class of products could have a material adverse effect on
sales of the affected products and on Amgen's business and results of

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operations. Amgen's efforts to integrate the operations of companies it has
acquired may not be successful. Amgen may experience difficulties, delays or
unexpected costs and not achieve anticipated cost savings from its ongoing
restructuring plan. Amgen's business performance could affect or limit the
ability of Amgen's Board of Directors to declare a dividend or their ability to
pay a dividend or repurchase Amgen common stock.
The scientific information discussed in this news release related
to Amgen's product candidates is preliminary and investigative.  Such product
candidates are not approved by the U.S. Food and Drug Administration (FDA), and
no conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)
References
1 Vassar, R. et al. "β-Secretase cleavage of Alzheimer's amyloid precursor
protein by the transmembrane aspartic protease BACE." Science 286.5440 (1999):
735-741.
2 Supporting deCODE genetic evidence:  Jonsson, T. et al. "A mutation in APP
protects against Alzheimer's disease and age-related cognitive decline." Nature
488.7409 (2012): 96-99.
3 Policy Brief for Heads of Government: The Global Impact of Dementia 2013-2015,
Alzheimer's Disease International (ADI), December 2013.
4 New Report Reveals Global Cost of Alzheimer's and Related Dementias is More
Than $600 Billion, Alzheimer's Association, 2010.
5 Vos et al. Years lived with disability (YLDs) for 1160 sequelae of 289
diseases and injuries 1990–2010: a systematic analysis for the Global Burden of
Disease Study 2010. The Lancet. 2012 Dec-2013 Jan;30(9859):2163-2196.
6 National Institute for Neurological Disorders and Stroke. Headache: Hope
Through
Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm.
Accessed June 4, 2015.
7 Migraine Research Foundation. Migraine Fact Sheet. 2015.
Available: http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed June 4, 2015.
8 Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors associated with the onset
and remission of chronic daily headache in a population-based study. Pain. 2003
Nov: 106(102:81-9).
9 National Headache Foundation. Migraine. Oct 2007.
Available: http://www.headaches.org/2007/10/25/migraine/. Accessed June 4, 2015.

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novartislogo.jpg [novartislogo.jpg]Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com

Novartis announces global partnership with Amgen to develop and commercialize
pioneering neuroscience treatments

•
The companies plan to co-develop and co-commercialize a BACE inhibitor program
in Alzheimer's Disease (AD); Novartis' oral therapy CNP520 will be the lead
molecule 
 

•
Novartis and Amgen also plan to co-develop and co-commercialize Amgen's migraine
portfolio, including fully human monoclonal antibody AMG 334 with first phase
III data expected in 2017
 

•
Partnership reinforces Novartis' continued commitment to developing and bringing
innovative neuroscience treatment options to patients

Basel, September 1, 2015 - Novartis announced today that it has entered into a
global collaboration with Amgen to commercialize and develop pioneering
neuroscience treatments. The companies will partner in the development and
commercialization of a BACE inhibitor program in Alzheimer's Disease (AD).
Novartis' oral therapy CNP520 will be the lead molecule and further compounds
from both company's pre-clinical BACE inhibitor programs may be considered as
follow-on molecules. The collaboration will also focus on new Amgen drugs in the
migraine field, including phase III AMG 334 and phase I AMG 301. For the
migraine program, Novartis will have global co-development rights and commercial
rights outside the U.S., Canada, and Japan.
"This Novartis collaboration with Amgen highlights our clear commitment to
neuroscience and to bring multiple, new targeted therapies to patients living
with Alzheimer's disease and migraine, where the unmet medical need remains
high." said David Epstein, Head of Novartis Pharmaceuticals.
Alzheimer's Disease is an irreversible, progressive brain disease characterized
by loss of memory and other cognitive abilities. Amyloid build-up is considered
a key driver of the progressive damage of the nervous system in AD. CNP520 is an
oral drug designed to prevent the production of different forms of amyloid and
has the potential to prevent, slow or delay the symptoms associated with AD. It
is currently in phase I/IIa trials. CNP520 is

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planned to be included in a pioneering prevention study in people with a genetic
risk of developing AD, in collaboration with the Banner Alzheimer's Institute.
Migraine is a severe headache condition affecting more than 10% of the
population[1] worldwide and a leading cause of disability. AMG 334 is a fully
human monoclonal antibody under investigation for the prevention of migraine.
AMG 334 inhibits the activity of Calcitonin-Gene-Related-Peptide (CGRP) by
targeting its receptor. CGRP is believed to play a key role in the development
of migraine. AMG 334 is currently under evaluation in several large global,
randomized, double-blind, placebo-controlled phase III trials to assess its
safety and efficacy in migraine prevention. In addition to AMG 334, the migraine
portfolio will include the development of AMG 301 and potentially another
investigational compound of Amgen. AMG 301 is a monoclonal antibody being
investigated in phase I trials for the prevention of migraine.
The partnership with Amgen follows two recent developments in the Novartis
neuroscience portfolio aimed at complementing Novartis' neuroscience presence
and pipeline in, among others, multiple sclerosis, AD and neuromuscular
diseases. In July 2015 Novartis acquired Spinifex Pharmaceuticals adding phase
II compound EMA401 for the treatment of neuropathic pain to the portfolio. In
August 2015 Novartis announced that it has entered into an agreement to acquire
all remaining rights to Ofatumumab from GlaxoSmithKline plc (GSK) for
relapsing-remitting multiple sclerosis (RRMS) and certain other autoimmune
indications; closing of this transaction is subject to expiry of any waiting
period under the US Hart-Scott-Rodino Act and other customary closing
conditions.
Under the terms of the arrangement, Novartis and Amgen will share
responsibilities for development and commercialization of the BACE inhibitor
program. Amgen will pay an upfront payment and milestone payments as well as
disproportional research and development costs for an agreed upon period
followed by a 50/50 cost and profit share arrangement. For the compounds in the
migraine field, Novartis receives global co-development rights and commercial
rights outside the U.S., Canada and Japan to the investigative molecules in
Amgen's migraine portfolio. This includes AMG 334 in phase III and AMG 301 in
phase I as well as an option to commercialize an additional early-stage Amgen
molecule in these territories. Novartis will fund disproportional global R&D
expenses for an agreed period on the migraine programs and will pay Amgen
double-digit royalties on sales.
About Alzheimer's 
It is estimated that around 44 million people globally have Alzheimer's or a
related dementia[2]. Alzheimer's Disease is an irreversible, progressive brain
disease that slowly destroys memory and thinking skills and, eventually even the
ability to carry out the simplest tasks of daily living. In most people with
Alzheimer's, symptoms first appear after age 60. Alzheimer's Disease is the most
common cause of dementia among older people. Although treatment can help manage
symptoms in some people, currently there is no cure for this devastating
disease.

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About Migraine
Migraine is a type of headache disorder that involves recurrent attacks of
moderate to severe pain that is typically pulsating, often unilateral and often
associated with nausea, vomiting and sensitivity to light, sound and odors.[1]
Headache disorders are underestimated, under-recognized and under-treated
throughout the world and are associated with personal and societal burdens of
pain, disability, damaged quality of life and financial cost.[3] There is a
significant need for tolerable and efficacious preventive medications for
migraine as discontinuation rates for existing oral preventive medications are
high.[4]
About Novartis in Alzheimer's Disease
Novartis has a strong commitment to the treatment and prevention of Alzheimer's
Dementia.
Exelon® Patch (rivastigmine transdermal system) is approved for the treatment of
mild-to-moderate Alzheimer's Disease (AD) dementia in more than 90 countries,
including more than 20 countries where it is also approved for Parkinson's
disease dementia. Exelon Patch is also indicated for the treatment of patients
with severe AD in 14 countries, including the US.
Novartis AD pipeline includes CNP520,an oral drug designed to prevent the
production of different forms of amyloid that has the potential to prevent, slow
or delay the symptoms associated with AD. It is currently in phase I/IIa trials.
The pipeline also includes investigational compound CAD106. This is an
anti-amyloid active immunotherapy which has completed phase IIa trials.
About collaboration with Banner Alzheimer's Institute (BAI)
In collaboration with the Banner Alzheimer's Institute (BAI), Novartis is
conducting a pioneering prevention study. The study with Banner is part of a
ground-breaking research program known as the Alzheimer's Prevention Initiative
and will involve more than 1,300 cognitively healthy adults, ages 60 to 75, with
a genetic risk of developing symptoms of AD because they inherited two genetic
copies of the apolipoprotein E epsilon 4 (APOE4) allele - one from each parent.
About 2 percent of the world's population has this genetic profile, which is
strongly linked to late-onset AD. One in four people carries one copy of the
APOE4 gene. Participants in the study will be given either CAD106 (not included
in the collaboration with Amgen), CNP520, or placebo. Pending regulatory
approval, the study is planned to start in late 2015/early 2016 in sites in
North America and Europe.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "plan," "will," "expected," "commitment," "may," "under
investigation," "under evaluation," "potentially," "investigational," "being
investigated," "aimed," "subject to," "investigative," "pipeline," "pending,"
"planned," or similar terms, or by express or implied discussions regarding
potential marketing approvals for CNP520, AMG 334, AMG 301, CAD106, other BACE
inhibitors of Novartis and Amgen, and other investigational compounds of
Novartis and Amgen subject to the partnership and collaboration, new indications
or labeling for Exelon Patch, or regarding potential future revenues from such
investigational compounds and products, and potential future revenues from the
partnership

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and collaboration with Amgen. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that CNP520, AMG 334, AMG
301, CAD106, other BACE inhibitors of Novartis and Amgen, and other
investigational compounds of Novartis and Amgen subject to the partnership and
collaboration will be submitted or approved for sale in any market, or at any
particular time. Nor can there be any guarantee that Exelon Patch will be
submitted or approved for any additional indications or labeling in any market,
or at any particular time. Neither can there be any guarantee that the
partnership and collaboration with Amgen will achieve any or all of its intended
goals and objectives, or be commercially successful. Nor can there be any
guarantee that Exelon Patch or any of the investigational compounds subject to
the partnership and collaboration with Amgen will be commercially successful in
the future. In particular, management's expectations regarding such
investigational compounds and products, and the partnership and collaboration
with Amgen could be affected by, among other things, the uncertainties inherent
in research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions or
delays or government regulation generally; the company's ability to obtain or
maintain proprietary intellectual property protection; general economic and
industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected safety issues; unexpected
manufacturing or quality issues, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please
visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis
at http://twitter.com/novartis(link is external).
References
[1.] National Institute for Neurological Disorders and Stroke. Headache: Hope

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

ThroughResearch. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm(link
is external). Accessed August 2015.      
[2.] Policy Brief for Heads of Government: The Global Impact of Dementia
2013-205. Published by Alzheimer's Disease International (ADI), London. December
2013.
[3.] World Health Organization. Headache disorders. Fact sheet
N°277. http://www.who.int/mediacentre/factsheets/fs277/en/(link is external).
2012.
[4.] Blumenfeld et al; Headache 2013; 53:644-655
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
 
Eric Althoff 
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile) 
eric.althoff@novartis.com
Angela Fiorin 
Novartis Global Pharma Communications
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+41 79 752 6955 (mobile) 
angela.fiorin@novartis.com

e-mail: media.relations@novartis.com
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For questions about the site or required registration, please
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41 61 324 7944
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e-mail: investor.relations@novartis.com
e-mail: investor.relations@novartis.com

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