Exhibit 10.44
Execution Version

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.

COLLABORATION AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
NOVARTIS PHARMA AG
DATED
APRIL 21, 2017

    

    

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Table of Contents
PAGE
1.
Definitions    1

2.
Collaboration Scope and Governance    14

2.1
Conduct of the Collaboration    14

2.2
US Committees and Teams.    14

2.3
US Committee Co-Chairs    16

2.4
US Committee Meetings    17

2.5
Decision Making    17

2.6
Interactions between the Joint US Leadership Team, US Collaboration Team, Joint
Project Teams, Sub-Committees and Collaboration Teams    18

2.7
Alliance Managers    18

2.8
Cost Overruns    18

2.9
Commercialization Budget Deadlocks    19

2.10
Amgen Territory    19

3.
Grant of License    19

3.1
Amgen Technology    19

3.2
Novartis Technology    19

3.3
Sublicensing    19

3.4
Provision of Know-How    20

3.5
Trademarks    20

3.6
Retained Rights and Limitations    22

4.
Development, Regulatory and Medical Affairs Activities    22

4.1
Responsibility for Development    22

4.2
Regulatory Matters.    22

4.3
Safety Agreement    24

4.4
Cooperation Generally    24

4.5
Medical Affairs Activities    24

4.6
[*]    24

5.
Commercialization    24

5.1
Responsibility for Commercialization    25

5.2
Materials    25

5.3
Training.    26

5.4
Information Concerning the Product    26

5.5
Cooperation Generally    26

5.6
Commercialization in the Amgen Territory    26

5.7
Detailing Reports and Audit Rights    27

5.8
Sales Force [*]    27

6.
Manufacture and Supply    28

6.1
Responsibility for Manufacturing    28

6.2
Distribution    28

6.3
Responsibility for Regulatory Filings with Respect to Manufacturing; Inspections
of Manufacturing Facilities    28

6.4
Supply [*]    28

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7.
Diligence    28

7.1
Commercially Reasonable Efforts    28

7.2
Proper Conduct Practices Standards    28

7.3
Violation of Laws    29

7.4
Use of Affiliates and Third Party Contractors    29

8.
Payment    29

8.1
Upfront Payment    29

8.2
Milestone Payments    29

8.3
Royalty Payments and Royalty Reduction for Biosimilar Competition    30

8.4
Reports    30

8.5
No Wrongful Reductions    31

8.6
Cost Allocation    31

8.7
Sublicense Payments    33

8.8
Payment Method    33

8.9
Audits    33

8.10
Blocked Currency    34

8.11
Taxes    34

8.12
Withholding    34

8.13
VAT    35

8.14
Late Payment    35

8.15
Appropriate Measure of Value    35

9.
Intellectual Property    35

9.1
Ownership and Cooperation    35

9.2
Prosecution and Maintenance    36

9.3
Defense and Settlement of Third Party Claims    38

9.4
Infringement Notice; Enforcement    39

9.5
Cooperation    41

9.6
Patent Term Extensions    41

9.7
Employee Agreements    41

10.
Confidentiality    42

10.1
Confidentiality; Exceptions    42

10.2
Authorized Disclosure    42

10.3
Use of Confidential Information and Data with Distracting Programs    43

10.4
Terms and Conditions Confidential    43

10.5
Attorney-Client Privilege    43

11.
Representations, Warranties and Covenants    44

11.1
Mutual Representations and Warranties    44

11.2
Novartis Representations and Warranties    45

11.3
Amgen Representations and Warranties    45

11.4
Disclaimer of Warranties    46

11.5
Mutual Covenants    46

11.6
Novartis Covenant    48

12.
Limitations of Liability; Insurance    48

12.1
Limitations of Liability    48

12.2
Insurance    48

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13.
Indemnification    48

13.1
Sharing of Liability Expenses    48

13.2
Indemnification by Novartis    49

13.3
Indemnification by Amgen    49

13.4
Claim for Indemnification    49

14.
Term and Termination    50

14.1
Term    50

14.2
Termination    50

14.3
Effect of Termination    51

14.4
Additional Surviving Provisions    52

14.5
Transition Period    53

15.
Miscellaneous    53

15.1
Affiliates    53

15.2
Assignment    53

15.3
Governing Law; Jurisdiction    53

15.4
Construction    54

15.5
Counterparts    54

15.6
Entire Agreement    54

15.7
Force Majeure    54

15.8
Further Assurances    55

15.9
Headings    55

15.10
No Set-Off    55

15.11
Notices    55

15.12
Relationship of the Parties    55

15.13
Severability    56

15.14
Third Party Beneficiaries    56

15.15
Waivers and Modifications    56

SCHEDULES

Amgen Patents
Press Release
[*]

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COLLABORATION AGREEMENT

PREAMBLE
This Collaboration Agreement (this “Agreement”), effective as of April 21, 2017
(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 and Novartis are parties to that certain Exclusive License and
Collaboration Agreement, dated as of August 28, 2015, pursuant to which (i) the
Parties are Developing the Product (as defined below) globally, and (ii) Amgen
granted to Novartis and Novartis obtained from Amgen, certain license rights to
commercialize the Product outside the United States, Canada and Japan (the
“Existing License Agreement”); and
WHEREAS, Amgen wishes to collaborate with Novartis, and Novartis wishes to
collaborate with Amgen, in each case with respect to the Commercialization of
and Medical Affairs Activities (each as defined below) with respect to the
Product in the Field in the United States (each as defined below) in accordance
with the terms and conditions hereof; and
WHEREAS, simultaneously herewith, the Parties are amending the Existing License
Agreement to include Canada within the Territory and to amend, modify and
restate certain terms and conditions of the Existing License Agreement in
connection with this Agreement; and
WHEREAS, the Amgen and Novartis are parties to that certain Pharmacovigilance
Agreement, which sets forth the operating procedure respecting adverse event
reporting and safety information exchange with respect to the Product (the
“Safety Agreement”).
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:
1.
DEFINITIONS

Capitalized terms herein that are not otherwise defined herein shall have the
meanings ascribed to such terms in the Existing License Agreement; provided that
any references to “Licensed Product” in any such definition shall, for purposes
of this Agreement, mean the Product.
1.1    “[*]” has the meaning set forth in Section [*].
1.2    “Agreement” has the meaning set forth in the Preamble.
1.3    “Alliance Managers” has the meaning set forth in Section 2.7 (Alliance
Managers).
1.4    “Amgen” has the meaning set forth in the Preamble.
1.5    “Amgen Assumed Item” has the meaning set forth in Section 9.2.4 (Amgen
Secondary Prosecution).

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1.6    “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 Amgen Product Trademarks, Novartis Product
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.
1.7    “Amgen Indemnitees” has the meaning set forth in Section 13.2
(Indemnification by Novartis).
1.8    “Amgen Know-How” means, with respect to the Product, Information
Controlled by Amgen or its Affiliates (including Amgen Development Data), as of
the Effective Date or thereafter during the Term, that is [*] for Novartis to
conduct Medical Affairs Activities with respect to or Commercialize the Product
in the Field in the United States.
1.9    “Amgen Patents” means, with respect to the Product, those patents and
patent applications set forth on the 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 United States Controlled by Amgen or its Affiliates on
or after the Effective Date (including an interest in a patent or Joint Patent
pursuant to Section 9.1 (Ownership and Cooperation)) that (i) would (absent the
licenses granted herein) be infringed by the Commercialization of, or the
conduct of Medical Affairs Activities with respect to, the Product in the Field
in the United States or (ii) would be [*] for the Commercialization of, or the
conduct of Medical Affairs Activities with respect to, the Product in the Field
in the United States. 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.
1.10    “Amgen Patent Schedule” means the schedule of Amgen Patents attached
hereto, which may be updated by Amgen from time to time upon reasonable notice
to Novartis.
1.11    “Amgen Product Trademarks” means, with respect to the Product, any
trademark rights Controlled or adopted by Amgen or its Affiliates on or after
the Effective Date for use with the Product in the Field in the United States
(not including any Housemarks and not including any such marks to the extent
such marks would conflict with any right of any Third Party).
1.12    “Amgen Technology” means (i) the Amgen Know-How and (ii) the Amgen
Patents.
1.13    “Amgen Territory” means (i) during the term of the Existing License
Agreement, Japan and any other country removed from the Territory (as defined in
the Existing License Agreement) in accordance with the terms of the Existing
License Agreement, and (ii) from and after the expiration or earlier termination
of the Existing License Agreement, worldwide other than the United States.
1.14    “Amgen Territory Patents and Trademarks” has the meaning set forth in
Section 9.3.2 (Amgen Territory Patents and Trademarks).
1.15    “[*]” has the meaning set forth in Section [*].

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1.16    “Biosimilar Product” means, with respect to the Product in the United
States, after Regulatory Approval of the Product in the United States, 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) the Product, (ii) has a purity, potency and safety
profile that has no clinically meaningful difference from the purity, potency
and safety profile of the Product, (iii) is approved for use pursuant to a
regulatory approval process in the United States that is based on reliance, at
least in part, on the Product, whether or not such regulatory approval was based
upon data generated by either Party filed with the applicable Governmental
Authority in the United States or was obtained using an abbreviated, expedited
or other process, and (iv) is sold in the United States by any Third Party.
1.17    “CIA” means a corporate integrity agreement or similar arrangement
entered into between a Party and a Governmental Authority in the United States.
1.18    “Claims” has the meaning set forth in Section 13.2 (Indemnification by
Novartis).
1.19    “CMC” means, for a given product, the chemistry, manufacturing and
controls for such product, as submitted to or specified by the FDA.
1.20    “CMC Core Dossier” has the meaning set forth in Section 6.3
(Responsibility for Regulatory Filings with Respect to Manufacturing;
Inspections of Manufacturing Facilities).
1.21    “Co-Chair” has the meaning set forth in Section 2.3 (US Committee
Co-Chairs).
1.22    “Commercial Lead” has the meaning set forth in Section 5.1
(Responsibility for Commercialization).
1.23    “Commercialization Budget” means the budget of Commercialization Costs
established by the USCT and approved by the JUSLT, covering all activities
contemplated by the applicable Commercialization Plan, as such budget may be
updated annually by the JUSLT in connection with updates to such
Commercialization Plan. The initial Commercialization Budget for the Product
shall be agreed in writing by the Parties on the Effective Date.
1.24    “Commercialization Costs” means all Costs incurred by a Party and its
Affiliates during the Term in connection with Commercialization activities
hereunder in accordance with the applicable Commercialization Plan and
Commercialization Budget, including without limitation, (i) selling expenses, or
other direct and indirect costs and expenses associated with marketing of the
Product for Commercialization in the Field in the United States, including Sales
Force Costs calculated in accordance with Section 8.6.5 (Calculation of Sales
Force Costs); (ii) costs for preparing and reproducing Detailing aids, Product
promotional materials and other promotional materials, costs of professional
education, product related public relations, relationships with opinion leaders
and professional societies, market research (before and after Regulatory
Approval for the Product in the United States, but excluding research relating
to product naming), healthcare economics studies and other similar activities
directly related to the Product; and (iii) the cost of activities related to
obtaining market access, reimbursement from payers, costs of sales and marketing
data, costs associated with training of the sales representatives incurred in
accordance with Section 5.3 (Training), sales meetings, samples, sales call
reporting, work on managed care accounts, costs related to customer service and
other sales and customer service-related expenses; in each case ((i) through
(iii)) to the extent (a) [*] and (b) included in the Commercialization Plan

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and Commercialization Budget. Such costs may also include actual out-of-pocket
costs for outside services and expenses (e.g., consultants, agency fees, meeting
costs, etc.). Commercialization Costs excludes the Costs of activities that
promote a Party’s therapeutic franchise or business as a whole, except to the
extent a portion of such Costs is reasonably allocated to the Product in
accordance with such Party’s cost accounting policies, as consistently applied
across such Party’s entire portfolio and [*].  For the avoidance of doubt,
Commercialization Costs shall exclude Medical Affairs Activities Costs.
1.25    “Commercialization Plan” means a strategic and operational
commercialization plan for the Product in the Field in the United States (which
plan will be updated and approved on a periodic basis but no less than annually
by the JUSLT), which sets forth, among other things, (i) a multi-year
Commercialization strategy that includes plans for market research, health
economics, pricing and reimbursement, value added initiatives, (ii) a multi-year
communications strategy that includes plans for public relations, conferences
and exhibitions and other external meetings and communications, publications and
symposia, internet activities and core brand package, (iii) an operating plan
for the implementation of such strategies on an annual basis, including without
limitation, information related to product positioning, target customers, core
messages to be communicated, share of voice requirements and pricing strategies,
all as developed and approved by the JUSLT, (iv) a level of Detailing activity
that would be [*] for a product having similar market potential, (v) a
Commercialization Budget, and (vi) all other activities to be conducted in
connection with the Commercialization of the Product in the Field in the United
States. The Commercialization Plan shall be consistent with the Global Brand
Plan and shall include the United States Brand Plan.
1.26    “Commercialize” means any and all processes and activities conducted to
establish and maintain sales for the Product, including to market, advertise,
promote, import, export, offer to sell (including pricing and reimbursement
activities), Detail, and/or sell the Product 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).
1.27    “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, conduct of Medical Affairs Activities with respect to, and
Commercialization of the 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 Product, and at a similar stage in its Development or product
life as the 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 the Product.
1.28    “Compliance Executive Officers” means the [*] for Novartis and the [*]
for Amgen.

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1.29    “Compliance Laws” has the meaning set forth in Section 1.70 (“Material
and Program Matter”).
1.30    “Confidential Information” has the meaning set forth in Section 10.1
(Confidentiality; Exceptions).
1.31    “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.
1.32    “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 its share of such
payments hereunder or it is subject to Section 8.7 (Sublicense Payments).
1.33    “Copyright” means all right, title and interest in and to all
copyrightable works and any copyright registration or corresponding legal right,
other than copyrights included under Trademarks.
1.34    “Costs” means both internal and external costs and expenses (including
the cost of allocated FTEs at the applicable FTE Rate).
1.35    “Critical Matter” means all decisions made by the JUSLT that, in the
reasonable opinion of either Party, are likely to have any of the following
impacts: (i) [*] under the Commercialization Plan; or (ii) [*] to a
Commercialization Plan or any change to a Commercialization Plan that results in
an increase, or decrease, of [*] percent ([*]%) or more to the then-current
budgeted amount of Commercialization Costs for any specific Calendar Year under
the applicable Commercialization Budget.
1.36    “Detail” means an interactive, one-on-one, face-to-face meeting, in an
individual or group practice setting, between one or more healthcare
professionals having prescribing authority or who is able to influence
prescribing decisions and one Amgen or Novartis (or their respective Affiliates)
sales representative during which uses, safety, effectiveness,
contraindications, side effects, warnings or other relevant characteristics of
the Product are discussed in an effort to increase prescribing preferences of
the Product for its approved uses. Details will not include (i) activities
conducted by medical support staff (such as Medical Liaisons) or (ii) unless the
Parties otherwise mutually agree in writing, E-details, activities conducted at
conventions or similar gatherings and activities performed by market development
specialists, managed care account directors and other personnel not performing
face-to-face sales calls or not specifically trained with respect to a
pharmaceutical product. When used as a verb, “Detail” or “Detailing” shall mean
to engage in a Detail.
1.37    “Development Lead” has the meaning set forth in Section 4.1
(Responsibility for Development).

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1.38    “Effective Date” has the meaning set forth in the Preamble.
1.39    “Executive Officers” means the [*] for Novartis and the [*] for Amgen.
1.40    “Existing License Agreement” has the meaning set forth in the Recitals.
1.41    “[*]” has the meaning set forth in Section [*].
1.42    “Field” means any and all uses for the diagnosis, prevention or
treatment of any disease or condition in all indications in humans.
1.43    “First Commercial Sale” means, with respect to the Product, the first
sale in the United States to a Third Party of the Product by or under the
authority of the Parties or their Affiliates or sublicensees after receipt of
Regulatory Approval for the Product in the United States. Sales for clinical
study purposes or compassionate, named patient or similar use shall not
constitute a First Commercial Sale.
1.44    “First Position Detail” means a Detail in which the applicable
pharmaceutical product is Detailed before any other product and/or the
predominant portion of time is devoted to the Detailing of such pharmaceutical
product.
1.45    “First Position Detail Equivalent Basis” has the meaning set forth in
Section 8.6.5 (Calculation of Sales Force Costs).
1.46    “Force Majeure” has the meaning set forth in Section 15.7 (Force
Majeure).
1.47    “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
Commercialization in accordance with the applicable Commercialization Plan, or
other activities, including Medical Affairs Activities, 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.
1.48    “FTE Rate” means the rates agreed by the Parties in writing as of the
Effective Date with respect to each of the functions identified by the Parties
in writing as of the Effective Date, each per FTE per year (as of the Effective
Date), increasing by [*] percent ([*]%) of the then-current FTE Rate on [*] 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).
1.49    “Global Brand Plan” means, with respect to the Product, the strategic
and high-level tactical, cross-functional Commercialization plan jointly
developed by Amgen and Novartis (including through the JSC) for the Product,
including the Global Payer Plan and Global Pricing Policy.
1.50    “Global Payer Plan” means, with respect to the Product, the global plan
for the 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 and
reimbursement for the Product.

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1.51    “Global Pricing Policy” means, with respect to the Product, the global
plan for the Product jointly prepared by Amgen and Novartis (including through
the JSC) that sets forth, globally and by region, the [*], target population and
[*] target for the Product.
1.52    “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.
1.53    “Housemarks” means the Novartis Housemarks or the Amgen Housemarks, as
the case may be.
1.54    “IND” means 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.
1.55    “Indemnified Party” has the meaning set forth in Section 13.4 (Claim for
Indemnification).
1.56    “Indemnifying Party” has the meaning set forth in Section 13.4 (Claim
for Indemnification).
1.57    “Initial Commercialization Guidance” has the meaning set forth in
Section 5.1 (Responsibility for Commercialization).
1.58    “Joint Compliance Contacts” has the meaning set forth in Section 2.2.5
(Joint Compliance Contacts).
1.59    “Joint Patent” means any invention, patent or patent application jointly
owned by the Parties pursuant to Section 9.1 (Ownership and Cooperation).
1.60    “Joint Project Team” or “JPT” has the meaning set forth in Section 2.2.6
(Joint Project Teams).
1.61    “Joint US Leadership Team” or “JUSLT” has meaning set forth in Section
2.2.1 (Joint US Leadership Team).
1.62    “JSC” means the Joint Steering Committee under the Existing License
Agreement established pursuant to Article 3 (Collaboration Scope and Governance)
of the Existing License Agreement.
1.63    “Liability” has the meaning set forth in Section 13.1 (Sharing of
Liability Expenses).
1.64    “[*]” has the meaning set forth in Section [*].
1.65    “Losses” has the meaning set forth in Section 13.2 (Indemnification by
Novartis).
1.66    “MA” or “Marketing Authorization” means an MAA that has been approved by
the applicable Governmental Authority to market the Product in the United
States.
1.67    “MAA” means a BLA in the United States.
1.68    “Manager” has the meaning set forth in Section 5.1 (Responsibility for
Commercialization).
1.69    “Manufacturing Lead” has the meaning set forth in Section 6.1
(Responsibility for Manufacturing).

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

1.70    “Material and Program Matters” means those matters specifically relating
to (i) the Commercialization activities or Medical Affairs Activities of the
Parties with respect to the Product in the United States contemplated by this
Agreement and (ii) a Material and Program Matters Item, which matters, in the
reasonable opinion of either Party, are likely to impact compliance with
(a) statutes, regulations and written directives of Medicare, Medicaid, or any
other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)),
(b) statutes, regulations, or written directives of the FDA, (c) the
Pharmaceutical Researchers and Manufacturers of America (PhRMA) Code or (d) any
CIA to which either of the Parties is subject (collectively ((a) through (d)),
“Compliance Laws”).
1.71    “Material and Program Matters Items” means those materials and programs
matters as agreed by the Parties in writing on the Effective Date. The Parties
may add or remove items to the Material and Program Matters Items upon mutual
written agreement in order to address changes to any Compliance Laws.
1.72    “Material Safety Issue” means a Party’s good faith belief that, after
reviewing applicable safety data and other relevant safety factors, the Product
should not [*].
1.73    “Materials Review Process” has the meaning set forth in Section 5.2
(Materials).
1.74    “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 clinical studies regarding, the
Product, as established by the applicable Party’s internal policies and
procedures and approved by the JSC, 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 scientific and clinical
information in support of an approved indication for the 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 or other means of
communication agreed by the Parties in writing.
1.75    “Medical Affairs Activities Costs” means Costs incurred by a Party and
its Affiliates during the Term and pursuant to this Agreement associated with
Medical Affairs Activities in the United States to the extent incurred in
accordance with the applicable Development Budget. For the avoidance of doubt,
Medical Affairs Activities Costs shall be included in Development Costs.
1.76    “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 the Product,
and are not sales representatives or otherwise engaged in direct selling or
promotion of the Product.
1.77    “Net Sales” means with respect to a given period and the Product, the
gross invoiced sales for the Product sold by or on behalf of Amgen or any of its
Affiliates or sublicensees hereunder in the United States for use in the United
States to Third Parties other than sublicensees in bona fide, arms-length
transactions, less the following charges or expenses as recorded on an accrual
basis, as determined in accordance with Amgen’s Accounting Standards as
consistently applied:
(i)    normal trade and cash discounts allowed and taken by the Third Party;

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(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)    sales taxes (such as VAT or its equivalent) and excise taxes, other
consumption taxes, customs duties and compulsory payments to governmental
authorities and [*] imposed upon the sale of the Product to Third Parties; and
(ix) following such deductions in (i) through (viii) above, less a deduction of
[*] percent ([*]%) for direct expenses related to the sales of the 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 Amgen and
its Affiliates and sublicensees shall be disregarded for purposes of calculating
Net Sales; (b) if the 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 Amgen’s Accounting Standards are met; and (c)
in the event that the Product is sold in the United States together with one or
more other therapeutically active ingredients or therapies not constituting the
Product for a single price (regardless of their packaging) (a “Combination
Product”), the Product shall be deemed to be sold in the United States for an
amount equal to the product of (i) the price at which the Combination Product
was sold in the United States and (ii) the fraction A/(A+B), where A is the
weighted (by sales volume) average sale price in the United States during the
applicable reporting period of the Product when sold alone, and B is the
weighted average sale price (by sales volume) in the United States 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 Product or other
therapeutically active ingredients or therapies than those that are included in
the Combination Product, then Amgen 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 Product or other therapeutically active ingredients or therapies, the
calculation of Net Sales for Combination Products will

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be agreed by the 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 Product at no charge for, or use of the Product without charge
in, clinical or preclinical trials shall not be included in Net Sales.
1.78    “Non-Promotional Materials” means all written materials relating to the
Product or Product indication under development, including technology related
thereto, that are not considered Promotional Materials and are intended for use
with an external audience to appropriately inform through scientific exchange
the public or healthcare community regarding the Product or an indication under
development therefor or disease awareness materials relating to the applicable
therapeutic area in the Field. Such materials include scientific congress booth
materials, media communications, Medical Affairs Activities materials and
similar documents, but exclude materials described in Section 10.4 (Terms and
Conditions Confidential) hereof and Section 11.6 (Publications and
Presentations) of the Existing License Agreement.
1.79    “Non-Specialty Targets” means those physicians and nurse practitioners,
other than Specialty Targets, that are reasonably expected to treat patients for
migraine headaches or other approved indications of the Product and are mutually
approved by the Parties on a periodic basis, no less than annually, for
Detailing the Product, which list may include: (i) primary care physicians and
nurse practitioners and (ii) physicians and nurse practitioners practicing in
the area of [*].
1.80    “Novartis” has the meaning set forth in the Preamble.
1.81    “Novartis Assumed Item” has the meaning set forth in Section 9.2.2
(Novartis Secondary Prosecution).
1.82    “Novartis Group” has the meaning set forth in Section 11.2.3.
1.83    “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 Novartis Product Trademarks, Amgen
Product 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.
1.84    “Novartis Indemnitees” has the meaning set forth in Section 13.3
(Indemnification by Amgen).
1.85    “Novartis Know-How” means, with respect to the Product, Information
Controlled, as of the Effective Date or thereafter during the Term, by Novartis
or its Affiliates (including Novartis Development Data) that is a Novartis
Improvement or is [*] for Amgen to conduct Medical Affairs Activities with
respect to or Commercialize the Product within the United States in the Field or
Manufacture the Product within or outside the United States in the Field.
1.86    “Novartis Patents” means, with respect to the Product, Patents
Controlled by Novartis or its Affiliates on or after the Effective Date
(including an interest in a patent or Joint Patent pursuant to Section 9.1
(Ownership and Cooperation)) that Cover the Product or a Novartis Improvement
that (i) would (absent the licenses granted herein) be infringed by the conduct
of Medical Affairs Activities with respect to, Manufacture or Commercialization
of the Product in the

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Field or (ii) would be [*] for the conduct of Medical Affairs Activities with
respect to or Commercialization of the Product within the United States in the
Field or Manufacture the Product within or outside the United States 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.
1.87    “Novartis Technology” means (i) the Novartis Know-How and (ii) the
Novartis Patents.
1.88    “Novartis Product Trademarks” means, with respect to the Product, any
trademark rights Controlled by Novartis or its Affiliates and designated by the
Parties for use with the Product in the Field in the United States (not
including any Housemarks and not including any such marks to the extent such
marks would conflict with any right of any Third Party).
1.89    “Obligations” has the meaning set forth in Section 11.2.3.
1.90    “Other Costs” means (i) Costs incurred by a Party and its Affiliates in
the prosecution and maintenance of Patents and Trademarks pursuant to Section
9.2 (Prosecution and Maintenance); (ii) Costs incurred by a Party and its
Affiliates in the defense and settlement of infringement and other suits
pursuant to Section 9.3 (Defense and Settlement of Third Party Claims);
(iii) Costs incurred by a Party and its Affiliates in enforcing Patents and
Trademarks pursuant to Sections 9.4.2 (Amgen Primary Enforcement), 9.4.3
(Novartis Secondary Enforcement), 9.4.4 (Novartis Primary Enforcement and 9.4.5
(Amgen Secondary Enforcement); (iv) subject to Section 8.7 (Sublicense
Payments), Third Party license fees, milestones, royalties or other payments
owed with respect to the Product (or its components, including devices) in the
United States or uses thereof (or its components, including devices), on
intellectual property (other than [*]) related to the Product (or its
components, including devices) that is licensed by either Party after the
Effective Date; (v) subject to Sections [*] and 8.7 (Sublicense Payments), Third
Party license fees, milestones, royalties or other payments owed with respect to
[*] of the Product for the United States that is licensed by either Party after
the Effective Date, including with respect to [*]; and (vi) Costs incurred by
the Parties pursuant to Section 13.1 (Sharing of Liability Expenses).
1.91    “Party” or “Parties” has the meaning set forth in the Preamble.
1.92    “Party Representatives” has the meaning set forth in Section 11.5.2.
1.93     “Product” means (i) Amgen’s proprietary monoclonal antibody against
calcitonin gene-related peptide (CGRP) receptor, known as AMG 334 or erenumab or
(ii) [*].
1.94    “Program Costs” means, with respect to the Product in the United States
for any Calendar Quarter, the following expenses that are incurred by a Party
and any of its Affiliates: (i) Commercialization Costs; and (ii) Other Costs;
provided that, in clause (i) above such costs shall be included within “Program
Costs” for the Product only to the extent consistent with the applicable
Commercialization Plan.  The components of Program Costs shall be calculated in
accordance with the applicable definition thereof and the applicable terms of
this Agreement.  Development Costs (including Medical Affairs Activities Costs)
are not included in Program Costs and vice versa.  If any cost or expense is
directly attributable or reasonably allocable to more than one activity, such
cost or expense shall only be counted as Program Costs with respect to one of
those activities.

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1.95    “Promotional Materials” has the meaning set forth in Section 5.2
(Materials).
1.96    “RACI Documents” means, with respect to the 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
Commercialization, Medical Affairs Activities and other Product-related
activities in the United States.
1.97    “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 Amgen Technology, Amgen Product Trademark, Novartis Technology, Novartis
Product Trademark, Joint Patent, Copyrights pertaining to Promotional Materials,
Non-Promotional Materials or training materials for the Product, or Amgen
Housemarks and Novartis Housemarks jointly used by the Parties, each of the
foregoing with respect to the Product in the Field in the United States.
1.98    “Regulatory Lead” has the meaning set forth in Section 4.2.1 (Regulatory
Responsibility, Communications and Filings).
1.99    “Safety Agreement” has the meaning set forth in the Recitals.
1.100    “Sales Force Costs” means the allocable share of each Party’s or any of
its Affiliates’ or contractors’ sales force costs for sales representatives that
Detail the Product in the Field in the United States in accordance with this
Agreement, calculated in accordance with Section 8.6.5 (Calculation of Sales
Force Costs); provided, that a Party’s contract sales force costs shall (i) be
such Party’s actual pass-through cost and (ii) in no event exceed amounts equal
to the Sales Force FTE Costs calculated in accordance with Section 8.6.5
(Calculation of Sales Force Costs) (i.e., contract sales force costs shall in no
event exceed the costs associated with a Party’s internal sales force).
1.101    “Sales Force FTE” means a full-time equivalent sales representative
(i.e., one fully-dedicated or multiple partially-dedicated sales representatives
aggregating to one full-time sales representative employed or contracted by
Amgen or Novartis based upon a total of [*] days per Calendar Year and [*]
Details per day undertaken in connection with the conduct of Details in
accordance with the applicable Commercialization Plan. Overtime, and work on
weekends, holidays and the like [*] be counted [*] toward the number of hours
that are used to calculate the Sales Force FTE contribution.
1.102    “Sales Force FTE Rate” means the applicable rate agreed by the Parties
in writing as of the Effective Date with respect to each Party’s sales
representatives, per Sales Force FTE per year (as of the Effective Date),
increasing by [*] percent ([*]%) of the then-current Sales Force FTE Rate on [*]
and each subsequent Calendar Year. The Sales Force 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).
1.103    “Sales Milestone” has the meaning set forth in Section 8.2.2.
1.104    “Sales Milestone Threshold” has the meaning set forth in Section 8.2.2.
1.105    “Second Position Detail” means a Detail in which the applicable
pharmaceutical product is Detailed in the second position (i.e., no more than
one (1) other product is presented to

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or discussed with the healthcare professional before the Product) and/or the
second most predominant portion of time is devoted to the Detailing of such
pharmaceutical product.
1.106    “Shared Liability Losses” has the meaning set forth in Section 13.1
(Sharing of Liability Expense).
1.107    “Specialty Targets” means (i) [*] and (ii) physicians and nurse
practitioners practicing in the area of [*], that (in the case of (i) and (ii))
are mutually approved by the Parties on a periodic basis, no less than annually,
for Detailing the Product.
1.108    “[*]” means the [*] set forth on the [*] Schedule.
1.109    “[*]” has the meaning set forth in Section [*].
1.110    “Targets” means Non-Specialty Targets and/or Specialty Targets, as the
context admits.
1.111    “Technology” means Information and Patents.
1.112    “Term” means the period beginning on the Effective Date and continuing
for as long as the Product is Commercialized by one or both Parties in the Field
in the United States, unless otherwise terminated pursuant to Article 14 (Term
and Termination).
1.113    “Termination Date” has the meaning set forth in Section 14.3.3.1
(Additional Termination Effects).
1.114    “Third Position Detail” means a Detail in which the applicable
pharmaceutical product is Detailed in the third position (i.e., no more than two
(2) other products are presented to or discussed with the healthcare
professional before the Product) and/or the third most predominant portion of
time is devoted to the Detailing of such pharmaceutical product.
1.115    “Transition Period” has the meaning set forth in Section 14.5
(Transition Period).
1.116    “United States” or “U.S.” means the United States of America, including
its territories and possessions (including the District of Columbia and Puerto
Rico).
1.117    “United States Brand Plan” means, with respect to the Product, the
United States-specific strategic and high-level tactical, cross-functional
Commercialization plan jointly developed by Novartis and Amgen (including
through the JUSLT) for the Product in the United States, including the United
States Payer Plan and the United States Pricing Policy.
1.118    “United States Novartis Patents and Trademarks” has the meaning set
forth in Section 9.2.3 (Novartis Primary Prosecution).
1.119    “United States Patents and Trademarks” has the meaning set forth in
Section 9.2.1 (Amgen Primary Prosecution).
1.120    “United States Payer Plan” means, with respect to the Product, the
United States-specific plan for the Product jointly prepared by Novartis and
Amgen (including through the JUSLT) that sets forth the strategic direction,
positioning, value proposition, pricing strategy, value evidence generation
plan, economic modeling strategy and reimbursement for the Product in the United
States.

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1.121    “United States Pricing Policy” means, with respect to the Product, the
United States-specific plan for the Product jointly prepared by Amgen and
Novartis (including through the JUSLT) that sets forth the proposed price range,
rebates and discounts range, target population and reimbursement target for the
Product in the United States.
1.122    “United States Senior Officers” means the [*] for Novartis and the [*]
for Amgen.
1.123    “US Biosimilar Entry Date” has the meaning set forth in Section 8.3.2
(Royalty Reduction for Biosimilar Competition).
1.124    “US Collaboration” has the meaning set forth in Section 2.1 (Conduct of
the Collaboration).
1.125    “US Collaboration Team” or “USCT” has the meaning set forth in Section
2.2.2 (US Collaboration Team).
1.126    “US Committee” has the meaning set forth in Section 2.2.3.
1.127     “US Medical Affairs JPT” means the Joint Project Team established by
the JSC pursuant to the Existing License Agreement to oversee Development
activities, Medical Affairs Activities and publications, in each case to the
extent relating solely to the United States.
2.
COLLABORATION SCOPE AND GOVERNANCE

2.1    Conduct of the Collaboration. The Parties shall cooperate to conduct
Medical Affairs Activities with respect to the Product in the Field in the
United States, and Commercialize the Product in the Field in the United States,
in each case in accordance with the terms and conditions of this Agreement (the
“US Collaboration”).
2.2    US Committees and Teams.
2.2.1    Joint US Leadership Team. Promptly but not later than thirty (30) days
following the Effective Date, the Parties shall establish a cross-functional
Joint US Leadership Team (the “Joint US Leadership Team” or “JUSLT”) to, upon
such formation, (i) review and approve plans and strategies for, and the conduct
and progress of, activities by each Party relating to Commercialization in the
United States with respect to the Product, including the applicable
Commercialization Plan and RACI Documents, and facilitate coordination of such
activities with Medical Affairs Activities with respect to the Product in the
United States; (ii) monitor the Parties’ activities under this Agreement
pursuant to the applicable Commercialization Plan, United States Brand Plan,
Commercialization Budget and RACI Documents; (iii) review and annually approve
the applicable Commercialization Budget no later than [*] of each Calendar Year;
(iv) approve the draft supply forecast for the Product in the United States;
(v) review sales forecasts for the Product in the United States; (vi) review any
anticipated disruption to supply of the Product in the United States;
(vii) direct and oversee any JPT, sub-committee and collaboration team
established by the JUSLT, on all significant issues that fall within the
responsibilities of such JPTs, sub-committees and collaboration team;
(viii) update the RACI Documents no later than [*] of each Calendar Year
commencing in Calendar Year [*] (i.e., for Calendar Year [*]); (ix) attempt to
resolve issues presented to it by, and disputes within, the USCT, the JPTs,
sub-committees and collaboration team in accordance with Section 2.5 (Decision
Making); and (x) make such determinations as are expressly delegated to it under
the terms of this Agreement. In accordance with Section 2.4 (US Committee
Meetings), each Party shall keep the Joint US Leadership Team informed of the
progress

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and results of its activities under the Commercialization Plan, United States
Brand Plan and RACI Documents through its members on the Joint US Leadership
Team and as otherwise provided herein.
2.2.2    US Collaboration Team. Promptly but not later than thirty (30) days
following the Effective Date, the Parties shall also establish a US
Collaboration Team (the “US Collaboration Team” or “USCT”) to have primary
responsibility for Commercialization matters in the United States. These
responsibilities shall include (i) preparing the Commercialization Plan,
Commercialization Budget and annual (or any other) updates thereto;
(ii) overseeing particular Commercialization projects and activities with
respect to the Product in the United States and facilitating coordination of
such projects and activities with particular Medical Affairs Activities projects
and activities with respect to the Product in the United States, (iii) preparing
a draft supply forecast for the Product for the United States; (iv) preparing
annually a [*] year sales forecast for the Product for the United States;
(v) discussing any anticipated disruption to supply of the Product in the United
States; and (vi) recommending to the JUSLT (a) the appropriate allocation of
Commercialization activities in the United States to Novartis or Amgen on an
activity-specific basis and (b) whether operational responsibility for any such
activity should be transferred from Novartis to Amgen or vice versa.
2.2.3    Each of the Joint US Leadership Team and the US Collaboration Team
(each a “US Committee”) will have solely the roles and responsibilities assigned
to it in this Article 2 (Collaboration Scope and Governance) and as otherwise
expressly set forth in this Agreement. Neither the US Committees nor a Party
exercising its final decision making authority pursuant to Section 2.5 (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.
2.2.4    Each US 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 each US Committee, up to [*] for each
of Amgen and Novartis, or such other number as the Parties may agree in writing;
provided that no representative, other than a representative in the medical
affairs function, shall be permitted to serve on (i) both the JUSLT and the
USCT, or (ii) either of the JUSLT or the USCT and any Committee (as defined in
the Existing License Agreement) established under the Existing License
Agreement. Each US Committee shall be composed of members of relevant functional
specialties and expertise. The members of each US Committee shall have the
appropriate level of seniority, decision-making authority and expertise
commensurate with the responsibilities of the US Committee to which they are
appointed. The Alliance Managers appointed by Amgen and Novartis pursuant to
Section 2.7 (Alliance Managers) are ex officio members of the JUSLT and the
USCT. Either Party may replace its respective US Committee representatives at
any time upon prior written notice to the other Party. In the event a US
Committee member from either Party is unable to attend or participate in a US
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 US Committee member and
its substitute representative are unable to attend or participate in a US
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 US Committee.

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2.2.5    Joint Compliance Contacts. Promptly but not later than thirty (30) days
following the Effective Date, the Parties shall each identify one representative
to manage Material and Program Matters in connection with this Agreement (the
“Joint Compliance Contacts”). The Joint Compliance Contacts shall be responsible
for ensuring that the Commercialization and Medical Affairs Activities of the
Parties with respect to the Product in the United States contemplated by this
Agreement occur in accordance with each Party’s healthcare compliance policies
and any CIA to which either of the Parties is subject. In the event either Party
becomes party to a new CIA after the Effective Date, the Parties will discuss in
good faith the implications of such new CIA. The Parties shall instruct the
Joint Compliance Contacts to work with the appropriate personnel of each Party
to accomplish the goals set forth in this Section 2.2.5 (Joint Compliance
Contacts). The review of any matter referred to the Joint Compliance Contacts in
accordance with this Agreement shall be conducted with the goal of resolving, or
creating a solution for, any issue presented to the Joint Compliance Contacts
arising from the Commercialization and Medical Affairs Activities of the Parties
with respect to the Product in the United States, taking into account each
Party’s healthcare compliance policies, any CIA to which either of the Parties
is subject, and any guidance received by the Parties during the proposal process
in respect of the matter which presented the issue referred to the Joint
Compliance Contacts for review. If, after [*] Business Days following referral
of the matter to the Joint Compliance Contacts, the Joint Compliance Contact of
either Party believes that the Joint Compliance Contacts have reached an
irreconcilable impasse despite following the escalation procedures set forth in
the Materials Review Process (to the extent applicable) and cannot agree to a
common approach, the Joint Compliance Contact of either Party may escalate the
issue to the Compliance Executive Officers for review; provided that if, in the
good faith determination of the Joint Compliance Contact of either Party,
resolution of such Material and Program Matter requires [*] pursuant to
applicable Law (e.g., upon an Governmental Authority request to withdraw a
Promotional Material), the Joint Compliance Contact of such Party will have the
right to immediately escalate the issue to the Compliance Executive Officers for
review. All such Material and Program Matters so escalated to the Compliance
Executive Officers shall [*].
2.2.6    Joint Project Teams. From time to time, the Joint US Leadership Team or
the Parties may establish permanent or ad hoc cross-functional or
function-specific joint project teams to undertake initiatives or analyses and
such joint project teams will be constituted as the Joint US Leadership Team
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 US Leadership Team for resolution as provided in
Section 2.5 (Decision Making).
2.2.7    Other Sub-Committees and Teams. The Parties may also establish other
committees, sub-committees or collaboration teams as the Parties deem
appropriate.
2.3    US Committee Co-Chairs. Each Party shall appoint one of its members in
each US Committee to co-chair such US Committee’s meetings (each, a “Co-Chair”).
The Co-Chairs shall (i) ensure the orderly conduct of the US Committee’s
meetings; (ii) attend each US Committee meeting (either in person, by
videoconference or telephonically); and (iii) ensure the preparation and
issuance of written minutes of each meeting within [*] Business Days thereafter
accurately reflecting the discussions and decisions of such meeting. Unless
otherwise agreed, the US Committee shall have at least one (1) representative
with relevant decision-making authority from each Party such that the US
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

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a US Committee meeting, the Party who designated such Co-Chair may designate a
substitute Co-Chair for the meeting in its sole discretion.
2.4    US Committee Meetings. Each of the Joint US Leadership Team and the US
Collaboration Team shall meet [*], or more or less often as otherwise mutually
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 of such US Committee. 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 US 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 US
Committee (in person, by videoconference or teleconference) with reasonable
prior written notice (it being agreed that at least ten (10) Business Days shall
constitute reasonable notice) to resolve particular matters requested by such
Party and within the decision-making responsibility of such US Committee. Each
Co-Chair shall ensure that its US Committee members receive adequate notice of
such meetings. Each US Committee shall have a secretary who may be an ex officio
member of that US Committee and shall prepare minutes for meetings he or she
attends. The Co-Chairs of each US Committee shall alternate responsibility for
naming the secretary at each meeting of such US Committee.
2.5    Decision Making. Other than as set forth herein, in order to make any
decision required of it hereunder, each US 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 JUSLT and USCT by mutual agreement of the
Co-Chairs. If the USCT is unable to reach a decision on any matter after
endeavoring in good faith to do so, the USCT Co-Chair of either Party may cause
such dispute to be referred to (i) the Joint Compliance Contacts for resolution
pursuant to Section 2.2.5 (Joint Compliance Contacts), if a Material and Program
Matter, (ii) the US Medical Affairs JPT for resolution, if a Medical Affairs
Activity matter or (iii) the JUSLT for resolution, if any matter other than a
Material and Program Matter or Medical Affairs Activity matter. If a dispute
(originating at either the USCT or the JUSLT) arises on a Critical Matter which
cannot be resolved within the JUSLT within [*] Business Days following referral
to the JUSLT, the Co-Chair of either Party may cause such dispute to be referred
to the Alliance Managers for escalation to the JSC for Critical Matters that are
strategic or scientific issues, or to the United States Senior Officers for all
other Critical Matters (including budget or resource allocation issues). If such
Critical Matter cannot be resolved between the United States Senior Officers
within [*] Business Days following referral to the United States Senior
Officers, either United States Senior Officer may cause such dispute to be
referred to the Alliance Managers for escalation to the Executive Officers. All
such Critical Matters so escalated to the Executive Officers [*]. Within the
Joint US Leadership Team, disputes (originating at either the USCT or the JUSLT)
regarding any matters that are not Critical Matters shall be resolved as
follows:
2.5.1    the Co-Chair of the Manufacturing Lead at the JUSLT shall have the
deciding vote with respect to all Manufacturing matters for the Product; and
2.5.2    the Co-Chair of the Commercial Lead for the Product at the JUSLT shall
have the deciding vote with respect to all Commercialization matters for the
Product in the United States, including any amendments to the Commercialization
Plan or Commercialization Budget relating to the Product in the United States;
provided that [*].

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For clarity, all Development, regulatory and Medical Affairs Activities matters
will be discussed and resolved at the JSC pursuant to Section 3.5 (Decision
Making) of the Existing License Agreement, taking into account recommendations
of the US Medical Affairs JPT and the JUSLT.
2.6    Interactions between the Joint US Leadership Team, US Collaboration Team,
Joint Project Teams, Sub-Committees and Collaboration Teams. The Parties
recognize that while they will establish the Joint US Leadership Team, US
Collaboration Team, Joint Project Teams, sub-committees and collaboration 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 US Leadership Team, US
Collaboration Team, Joint Project Teams, sub-committees and collaboration 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.
2.7    Alliance Managers. Promptly but not later than thirty (30) 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,
Manufacturing, Medical Affairs Activities and Commercialization matters to act
as its respective alliance manager(s) for the US 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
JUSLT, USCT, Joint Project Teams, sub-committees and collaboration teams.
Consistent with the Commercialization Plan and Section 2.5 (Decision Making),
each Alliance Manager, on behalf of the applicable Party’s Co-Chair of the JUSLT
and on behalf of the United States Senior Officers and Executive Officers, will
also be responsible for:
2.7.1
providing a single point of communication for seeking consensus both within the
respective Party’s organization and together with the other Party regarding key
strategy and plan issues; and

2.7.2
identifying and raising disputes to the JSC, JUSLT, United States Senior
Officers or Executive Officers for discussion in a timely manner.

During the term of the Existing License Agreement, the Alliance Managers
appointed under the Existing License Agreement shall also serve as the Alliance
Managers under this Agreement. The Alliance Managers shall be entitled to attend
all JUSLT and USCT meetings, and shall have the right to attend all JPT,
sub-committee and collaboration team meetings. Consistent with Section 2.5
(Decision Making), each Alliance Manager may bring any matter to the attention
of the JSC, JUSLT, United States Senior Officers or the Joint Compliance
Contacts, where such Alliance Manager reasonably believes that such matter
requires attention of the JSC, JUSLT, United States Senior Officers, Executive
Officers or the Joint Compliance Contacts.
[*]
2.8    Cost Overruns. With respect to the Product, each Party, through the
JUSLT, shall promptly notify the other Party upon becoming aware that its
Program Costs to be incurred in

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performing the applicable Commercialization 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 Commercialization activities in the applicable budget. If the applicable
Program Costs incurred by a Party for performing the applicable
Commercialization Plan for a Calendar Year exceed the amounts budgeted to be
incurred by or on behalf of such Party for its Commercialization activities in
the applicable budget, the other Party shall reimburse the performing Party for
the applicable percentage set forth above of such excess; provided that in no
event shall either Party be responsible for reimbursement for such excesses to
the extent the Program Costs of the other Party in performing the
Commercialization Plan for a Calendar Year exceed the amounts budgeted to be
incurred by or on behalf of such other Party for its Commercialization
activities in the applicable budget by more than [*] percent ([*]%); provided
that a Party shall be responsible for reimbursement for such excesses to the
extent the applicable Program Costs are attributable to (i) a change in
applicable Law; (ii) a Force Majeure event; or (iii) a mutually agreed amendment
to the applicable Commercialization Plan.
2.9    Commercialization Budget Deadlocks. In the event that the JUSLT is unable
to approve a Commercialization Budget for a Calendar Year prior to the start of
such Calendar Year, then, until approval of such budget by the JUSLT, (i) the
Commercialization Budget most recently approved by the JUSLT for such Calendar
Year (or if not JUSLT approved, the initial apportioned amount for such Calendar
Year in the initial Commercialization Budget) shall apply and (ii) if not
approved by the JUSLT and no apportioned amount for such Calendar Year is
included in such applicable budget, then the apportionment for the prior
Calendar Year shall apply.
2.10    Amgen Territory. Unless expressly set forth in this Agreement or the
Existing License Agreement otherwise, Amgen shall have the sole decision-making
authority with regard to Development, regulatory, Medical Affairs Activities,
Manufacturing and Commercialization of the Product in the Amgen Territory.
Unless expressly permitted in this Agreement or the Existing License Agreement,
Novartis and its Affiliates shall not Develop or Commercialize or conduct
Medical Affairs Activities with respect to the Product in any country in the
Amgen Territory.
3.
GRANT OF LICENSE

3.1    Amgen Technology. Amgen hereby grants to Novartis, during the Term,
effective as of the Effective Date, [*] license (i.e., [*]) under the Amgen
Technology and Amgen’s interest in the Joint Patents to conduct Medical Affairs
Activities with respect to and Commercialize the Product in the Field in the
United States, in each case to the extent [*] to perform its obligations and
exercise its rights in accordance with the terms of this Agreement. Such license
shall include the right to sublicense only as set forth in Section 3.3
(Sublicensing).
3.2    Novartis Technology. Novartis hereby grants to Amgen, effective as of the
Effective Date, [*], perpetual license (i.e., [*]), under the Novartis
Technology and Novartis’ interest in the Joint Patents to sell, import, conduct
Medical Affairs Activities with respect to, and otherwise Commercialize the
Product in the Field in the United States and to Manufacture the Product inside
or outside of the United States. Such license shall include the right to
sublicense only as set forth in Section 3.3 (Sublicensing).
3.3    Sublicensing. Each Party shall have the right to sublicense the rights
granted to it hereunder solely to permitted (pursuant to Section 7.4 (Use of
Affiliates and Third Party Contractors)) contractors, agents or other Third
Parties performing activities under this Agreement

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on behalf of such Party or its Affiliates, subject to the terms and conditions
of this Section 3.3 (Sublicensing). Each Party shall have the right to
sublicense the rights granted it hereunder (i) as mutually agreed by the
Parties; and (ii) to subcontractors in the ordinary course of business
consistent with the Commercialization Plan, provided that [*]. Amgen shall also
have the right to sublicense the rights granted to it hereunder to those parties
to which Amgen (or its Affiliate or licensee) is also granting licenses to Amgen
patents or know-how relating to the Product or the use thereof (other than a
global sublicense of all rights to Develop the Product). The Party granting the
sublicense hereunder will remain responsible for the full 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 relating to Manufacturing). 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. Each
Party shall provide the other Party a copy of each final executed sublicense
agreement (other than a sublicense to a contractor), redacted for information
not pertinent to this Agreement. 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.
3.4    Provision of Know-How. Following the Effective Date, the Parties shall
cooperate to establish procedures for the provision of the Amgen Know-How
relating to the Product to Novartis and Novartis Know-How relating to the
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, during the Term, Amgen shall use [*] to provide all
Amgen Know-How related to the Product to Novartis, and Novartis shall [*] to
provide all Novartis Know-How related to the 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, each of the
Parties shall provide to the other any Amgen Know-How or Novartis Know-How
related to the Product (respectively) as the other Party shall reasonably
request; provided that a Party shall not be obligated to disclose any Amgen
Know-How or 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 3.4 (Provision of Know-How) shall be disclosed in the English language.
3.5    Trademarks.
3.5.1    Grant to Amgen. Novartis hereby grants to Amgen, effective as of the
Effective Date (without any further action by either Party), [*], royalty-free
right and license during the Term, subject to the terms and conditions hereof,
solely to sell, import, conduct Medical Affairs Activities with respect to, and
otherwise Commercialize the Product in the Field in the United States under
Novartis Product Trademarks designated by the Parties for use with the Product
in accordance with the Commercialization Plan and this Agreement. Novartis
hereby grants to Amgen [*], royalty-free license to use the Novartis Housemarks
solely as set forth in the Promotional Materials, Non-Promotional Materials and
other materials provided to it by Novartis, and solely to sell, import, conduct
Medical Affairs Activities with respect to, and otherwise Commercialize the
Product in the

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Field in the United States in accordance with the Commercialization Plan and
this Agreement. Such licenses shall include the right to sublicense only as set
forth in Section 3.3 (Sublicensing).
3.5.2    Grant to Novartis. Amgen hereby grants to Novartis, effective as of the
Effective Date (without any further action by either Party), [*], royalty-free
right and license during the Term, subject to the terms and conditions hereof,
solely to conduct Medical Affairs Activities with respect to and Commercialize
the Product in the Field in the United States under Amgen Product Trademarks
designated by Amgen for use with the Product in accordance with the
Commercialization Plan and this Agreement. Amgen hereby grants to Novartis [*],
royalty-free license to use the Amgen Housemarks solely as set forth in the
Promotional Materials, Non-Promotional Materials and other materials provided to
it by Amgen, and solely to sell, import, conduct Medical Affairs Activities with
respect to and otherwise Commercialize the Product in the Field in the United
States in accordance with the Commercialization Plan and this Agreement. Such
licenses shall include the right to sublicense only as set forth in Section 3.3
(Sublicensing).
3.5.3    Trademark and Housemark Quality Standards. Each Party shall (i)
maintain such reasonable quality standards for the Trademarks and Housemarks of
the other Party as it maintains for its own Trademarks and Housemarks 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 Trademark or Housemark of the other
Party in a manner that suggests any connection with any product or service,
other than use associated with the Product or any service associated with the
Product (including use associated with the Product or service associated with
the Product that may also include another product or a product promoted together
with the Product); and (iii) not use or display the Trademarks or Housemarks of
the other Party in any manner that might dilute, tarnish, disparage or reflect
adversely on the other Party or such marks. Prior to using any Trademark or
Housemark of the other Party, the Party that owns such Trademark or Housemark
shall provide to the other Party a guideline for use of such Trademark or
Housemark, including the review procedure and timing. From time to time, upon
request by the Party that owns such Trademark or Housemark, the other Party
shall provide copies of the usage of such Trademark or Housemark used in the
marketing or promotion of the Product in order to review such usage. Unless
otherwise stated hereinafter, each Party agrees that it shall not seek to
register or obtain ownership rights in any Novartis Product Trademark or any
Novartis Housemark (in the case of Amgen) or any Amgen Product Trademark or any
Amgen Housemark (in the case of Novartis) (or confusingly similar trademark) as
a Trademark anywhere in the United States.  
3.5.4    Domain Names. Novartis shall be [*] entitled to register, own and use
any Domain Names corresponding to or containing a Novartis Product Trademark or
Novartis Housemark in any generic Top Level Domains (gTLDs), including the new
and to be introduced gTLDs, and in any country code Top Level Domains (ccTLDs).
Novartis shall own all goodwill associated with all Domain Names corresponding
to or containing a Novartis Product Trademark or Novartis Housemark throughout
the world. Amgen shall be [*] entitled to register, own and use any Domain Names
corresponding to a nonproprietary name of the Product or containing an Amgen
Product Trademark or Amgen Housemark in any generic Top Level Domains (gTLDs),
including the new and to be introduced gTLDs, and in any country code Top Level
Domains (ccTLDs). Amgen shall own all goodwill associated with all Domain Names
corresponding to or containing a nonproprietary name of the Product or an Amgen
Product Trademark or Amgen Housemark throughout the world. Each Party shall have
the option to request to the other Party, which shall give due consideration

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to such request, an authorization to register, own and/or use any of the Domain
Names mentioned hereinabove and containing the nonproprietary name of the
Product or other Party’s Trademark but excluding the other Party’s Housemark.
3.5.5    Housemarks. Promotional Materials and all packaging and package inserts
for the Product in the Field in the United States will display the Novartis
Housemarks and the Amgen Housemarks in equal prominence to the extent allowed by
applicable Law and in accordance with the applicable Commercialization Plan, and
to the extent reasonably practicable; provided that, in the event that it is not
reasonably practicable to display the Novartis Housemarks on any packaging or
package inserts, the Parties shall discuss such matter, and the Novartis
Housemarks shall be displayed as soon as reasonably practicable. Except for the
use of the Novartis Housemarks and the Amgen Housemarks as may be expressly set
forth in the applicable Commercialization Plan, each Party will promote the
Product in the Field in the United States only under the Novartis Product
Trademarks or Amgen Product Trademarks, as applicable.
3.6    Retained Rights and Limitations. No rights to either Party’s Patents,
Trademarks, Housemarks or other proprietary rights are granted pursuant to this
Agreement except as expressly set forth herein, and all other rights are
reserved. Notwithstanding the licenses granted in this Article 3 (Grant of
License), each Party retains rights to perform (itself or through its Affiliates
or contractors) its obligations under this Agreement and the Existing License
Agreement.
4.
DEVELOPMENT, REGULATORY AND MEDICAL AFFAIRS ACTIVITIES  

4.1    Responsibility for Development. Except as otherwise set forth in this
Section 4.1 (Responsibility for Development), from and after the Effective Date,
responsibility for Development shall be as set forth in the Existing License
Agreement. Amgen will be the “Development Lead” for the Product for the United
States and shall have primary responsibility for Development activities for the
Product in the United States in accordance with the applicable Development Plan
and Development Budget, and Novartis shall provide both strategic input and
operational support for such activities as agreed in the applicable Development
Plan and Development Budget. For clarity, without the prior written consent of
Novartis, Amgen shall not undertake any Development activities in the Amgen
Territory that would [*] or the US Collaboration.
4.2    Regulatory Matters.

4.2.1    Regulatory Responsibility, Communications and Filings. Subject to this
Section 4.2.1 (Regulatory Responsibility, Communications and Filings), Amgen
shall be the regulatory lead in the United States (the “Regulatory Lead”) and
shall have primary responsibility for regulatory activities relating to the
Product in the United States, including preparing, submitting and maintaining
all Regulatory Filings in the United States in accordance with the Development
Plan, and Novartis shall provide strategic input for such activities therefor as
set forth in the Development Plan. Unless [*] is required with respect to such
Regulatory Filing or a material communication with a Governmental Authority in
the United States with respect to the Product, the Regulatory Lead shall provide
the other Party with draft copies of material Regulatory Filings (which, for
clarity, shall not be required to include communications that are solely
administrative in nature) in the United States prior to submission within a
reasonable amount of time and [*] 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 JUSLT for review). The
Regulatory

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Lead shall consult with the other Party regarding, and keep the 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 in the United States, Governmental
Authority review of any such Regulatory Filings, and all Regulatory Approvals
that it obtains with respect to the Product in the United States. The Regulatory
Lead shall provide to the other Party copies of all final Regulatory Filings it
submits in the United States promptly after the submission (but, with respect to
Regulatory Filings other than MAAs, MAs and INDs, in no event later than [*]
days after submission, and with respect to MAAs, MAs and INDs, within such time
period as agreed by the Parties). Notwithstanding the foregoing, Amgen shall
have no obligation to share with the non-Regulatory Lead the contents of the CMC
Core Dossier. Amgen shall be the regulatory lead in the Amgen Territory and
shall have responsibility for regulatory activities relating to the Product in
the Amgen Territory, including preparing, submitting and maintaining all
Regulatory Filings in the Amgen Territory in accordance with the Development
Plan, and Novartis shall provide strategic input for such activities therefor as
set forth in the Development Plan; provided that the Parties acknowledge and
agree that such obligations of Novartis shall not apply (i) with respect to
Japan except to the extent included in the Development Plan or (ii) from and
after expiration or earlier termination of the Existing License Agreement.
4.2.2    Regulatory Meetings. The Regulatory Lead shall consult with the other
Party reasonably in advance of the date of any anticipated meeting with a
Governmental Authority in the United States with respect to the Product and
shall consider any timely recommendations made by such other Party in
preparation for such meeting. Based on the discussions between the Regulatory
Lead and the non-Regulatory Lead, the Regulatory Lead shall create an agenda for
such meeting and use good faith judgment to assign roles to each of the
Regulatory Lead and non-Regulatory Lead, as appropriate based on the expertise
of such participants. One or more (up to [*]) representatives of the
non-Regulatory Lead [*] scheduled meetings between the Regulatory Lead and the
applicable Governmental Authority in the United States with respect to the
Product, and shall participate in such meetings consistent with the agenda for
the meeting created by the Regulatory Lead and the role(s) assigned to the
non-Regulatory Lead by the Regulatory Lead thereunder, in each case to the
extent permissible by such Governmental Authority. The Regulatory Lead shall
inform the other Party of any unscheduled teleconferences and meetings (other
than teleconferences and meetings that are solely administrative in nature) with
Governmental Authorities in the United States with respect to the Product
reasonably promptly after they occur. Notwithstanding the foregoing, Novartis
shall not have any right to attend any portions of meetings between Amgen and
the applicable Governmental Authority in the United States with respect to
Product manufacturing or CMC information (or any such meetings solely with
respect to Product manufacturing or CMC information).
4.2.3    Ownership of Regulatory Filings and Regulatory Approvals. Unless the
Parties agree otherwise, Amgen or its Affiliate shall own all right, title and
interest in and to any and all Regulatory Filings and Regulatory Approvals with
respect to the Product in the United States and all such Regulatory Filings and
Regulatory Approvals shall be held in the name of Amgen or its Affiliate, and
Novartis shall execute all documents and take all actions as are reasonably
requested by Amgen to vest such title in Amgen or its Affiliate, subject to
Section 5.5 (Safety Matters) of the Existing License Agreement, the Safety
Agreement and Section 6.3 (Responsibility for Regulatory Filings with Respect to
Manufacturing; Inspections of Manufacturing Facilities).

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4.2.4    Right of Reference. From and after the Effective Date, upon the request
of Amgen, Novartis shall provide a sublicensable right of reference to any
requested Regulatory Filings or Regulatory Approvals for the Product (provided
that Novartis shall not grant a right of reference to Novartis [*] Data and any
Regulatory Filings or Regulatory Approvals specific to Novartis [*] Data), as
[*] for Amgen’s (i) Manufacture within or outside the United States, or
(ii) conduct of regulatory activities and Medical Affairs Activities with
respect to, or Commercialization of, the Product in the Field in the United
States as permitted hereunder.
4.2.5    Material Safety Issue. In the event that either Party believes in good
faith that there is a Material Safety Issue with respect to the Product in the
United States, and the other Party disagrees with such belief, either Party may
request that the issue be discussed at the JSC for resolution. If the JSC cannot
resolve such matter within [*] Business Days following referral to the JSC,
notwithstanding Section 3.5 (Decision Making) of the Existing License Agreement,
the Co-Chair (as defined in the Existing License Agreement) of either Party at
the JSC may cause such matter to be referred to the Alliance Managers for
escalation to the JMC (as defined in the Existing License Agreement) for
resolution. If the JMC cannot resolve such matter within [*] Business Days
following referral to the JMC, notwithstanding anything to the contrary set
forth herein or in the Existing License Agreement, the [*] shall have the
deciding vote with respect to such matter. Notwithstanding the foregoing, [*] in
the event that [*] a Material Safety Issue with respect to the Product in the
United States.
4.3    Safety Agreement. Promptly following the Effective Date, Amgen and
Novartis shall amend the Safety Agreement to include safety data exchange
procedures governing the coordination of collection, investigation, reporting,
and exchange of information concerning adverse events with respect to the
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 regulations. Details of the operating procedure
respecting such adverse event reports and safety information exchange shall be
the subject of a mutually-agreed amendment to the Safety Agreement which shall
be entered into within ninety (90) days after the Effective Date (or any other
longer period as may be agreed between the Parties).
4.4    Cooperation Generally. From and after the Effective Date, subject to the
oversight of the JUSLT, the Parties shall provide each other with any
cooperation reasonably requested by the other with respect to the Regulatory
Approval for the Product in the United States.
4.5    Medical Affairs Activities. From and after the Effective Date, subject to
the oversight of the US Medical Affairs JPT and the JSC, the Parties shall be
jointly responsible for determining and providing all Medical Affairs Activities
relating to the Product in the Field in the United States. The US Medical
Affairs JPT will (i) allocate Medical Affairs Activities to Novartis or Amgen on
an activity-specific basis, and (ii) determine whether operational
responsibility for any such activity should be transferred from Novartis to
Amgen or vice versa. Except as expressly set forth herein or in the Existing
License Agreement, Amgen shall be solely responsible for the conduct of Medical
Affairs Activities with respect to the Product in the Amgen Territory and
Novartis shall have no rights with respect thereto.
4.6    Additional Products [*]

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5.
COMMERCIALIZATION

5.1    Responsibility for Commercialization. Consistent with this Section 5.1
(Responsibility for Commercialization), the Parties, through the USCT, will
jointly (i) develop objectives and strategy for Commercialization in accordance
with applicable Laws and regulations and (ii) oversee Commercialization
activities with respect to all indications for the Product in the Field in the
United States. From and after the Effective Date, the Parties shall jointly
Commercialize the Product in the Field in the United States in accordance with
the applicable Commercialization Plan. Amgen shall serve as the distributor and
the obligor of sale transactions with respect to the Product in the United
States (i.e., having responsibility for contracting, billing and interacting
with wholesaler customers and governmental or similar payors, as well as
government price reporting) (the “Commercial Lead”), and shall have authority to
[*], and shall [*].
In accordance with this Section 5.1 (Responsibility for Commercialization), the
USCT shall recommend and the JUSLT shall approve either Novartis or Amgen or
both as the “Manager” for specific Commercialization activities on an
activity-specific basis. The Manager shall have operational responsibility for
the execution of any such assigned Commercialization activities. The other Party
shall support the Manager by providing strategic input and operational support
for the Manager’s Commercialization activities.
With respect to Detailing efforts, the Parties shall use Commercially Reasonable
Efforts to divide Detailing activities between the Parties so that (a) the
Parties shall co-Detail Specialty Targets [*], and (b) as between the Parties,
Amgen shall Detail the Non-Specialty Targets; provided that, [*]. The guiding
principles for the initial Commercialization Plan for the Product (the “Initial
Commercialization Guidance”) shall be agreed in writing by the Parties on the
Effective Date. Within [*] following the Effective Date, the Parties shall agree
in writing to the initial Commercialization Plan for the Product, which shall be
based on and consistent with the Initial Commercialization Guidance. [*]
Calculation of such Details shall be included in such Party’s Sales Force Costs,
in accordance with Section 8.6.5 (Sales Force Costs). Subject to the foregoing,
Novartis and Amgen shall share Commercialization responsibilities as provided in
the applicable Commercialization Plan in the United States including with
respect to: (w) determination of commercial strategies (e.g., strategies for
branding, product positioning, pre-launch activities (e.g., market research),
launch and post-launch marketing and promotion, market access and field sales
force optimization); (x) determination of packaging and labeling; (y) creation
of promotional materials regarding the Product which are intended for
distribution to Third Parties (including medical professionals) and to such
Party’s sales force (subject to Section 3.5.3 (Trademark and Housemark Quality
Standards) and Section 5.2 (Materials)); and (z) determining and conducting
promotion activities. Amgen shall book sales (i.e., recognizing all revenue) and
conduct all sales and distribution activities, including pricing, taking orders
and distributing, contracting, handling of returns, handling all aspects of
order processing, invoicing and collecting, warehousing, documenting inventory
and receivables, call reporting, government price reporting, handling data
regarding sales to hospitals and other end users and handling all other customer
service-related functions. [*]
5.2    Materials. On the Effective Date, the Parties shall agree in writing to a
process (the “Materials Review Process”) by which the Parties will, in
accordance with the RACI Documents, jointly develop, review, comment on and,
subject to Sections 2.2.5 (Joint Compliance Contacts) and 2.5 (Decision Making),
approve (i) all written sales, educational, promotional and advertising

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materials relating to the Product in the United States, and other media and
materials used in the United States to promote the Product or educate patients,
consumers and healthcare professionals regarding an indication treated with the
Product (collectively and including translations, “Promotional Materials”), (ii)
all Non-Promotional Materials, including disease awareness programs, for the
United States, and (iii) training materials and programs for the Product in the
United States other than healthcare compliance or other non-Product training
materials. All Promotional Materials, Non-Promotional Materials and training
materials shall comply with applicable Law, FDA requirements and any CIA and
shall include, to the extent permitted by applicable Law, the Novartis
Housemarks and the Amgen Housemarks; provided that [*]. Unless otherwise
determined by the US Collaboration Team, the Manager for Promotional Materials,
Non-Promotional Materials and training materials production and delivery will be
responsible for ensuring the production and delivery to the other Party of
Promotional Materials, Non-Promotional Materials and training materials for use
in such other Party’s Detailing obligations hereunder. Other than a Party’s use
and distribution of Promotional Materials, Non-Promotional Materials and
training materials that are approved in accordance with the foregoing process
and used and distributed in connection with a Party’s Detailing of the Product,
neither Party will produce or modify (other than as concepts for consideration
by the other Party), or distribute, disseminate or otherwise use any other
promotional material, non-promotional material or training material relating to
the Product in the United States. If so instructed by the US Collaboration Team,
a Party will immediately cease to use any Promotional Materials, Non-Promotional
Materials and training materials and will collect and destroy any such materials
from its field sales teams (and record and document such collection and
destruction (and provide a copy of such documentation to the other Party upon
request)). The Parties shall jointly own all right, title and interest in and to
any and all Promotional Materials, Non-Promotional Materials and training
materials for the Product in the United States (except with respect to any
Housemarks of the other Party included in any Promotional Materials,
Non-Promotional Materials and training materials).
5.3    Training. The training of the Parties’ sales forces and other customer
facing personnel for Commercialization of the Product in the United States shall
be conducted using only training materials and programs approved in accordance
with the process set forth in Section 5.2 (Materials). Each Party shall train
its respective sales representatives and other customer facing personnel with
respect to the promotion of the Product in the United States (and update such
training from time to time as appropriate) which training will include
healthcare compliance training as appropriate, all in accordance with the
applicable Commercialization Plan.
5.4    Information Concerning the Product. Each Party will ensure that no claims
or representations in respect of the Product or the characteristics thereof are
made by or on behalf of it or its Affiliates (by sales force members or
otherwise) in the United States that have not been approved by both Parties
through the joint review process as set forth in the Materials Review Process
and neither Party will make any claim or representation in the United States
that does not represent an accurate summary or explanation of the labeling of
the Product.
5.5    Cooperation Generally. Subject to the oversight of the JUSLT, the Parties
shall cooperate generally with respect to the Commercialization of the Product
in the Field in the United States.

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5.6    Commercialization in the Amgen Territory. Except as expressly set forth
herein or in the Existing License Agreement, Amgen shall be solely responsible
for the Commercialization of the Product in the Amgen Territory and Novartis
shall have no rights with respect thereto.
5.7    Detailing Reports and Audit Rights.
5.7.1    Reporting. Each Party will provide the other Party with a report, in
such form and manner as determined by the JUSLT, within [*] calendar days after
the end of each [*], setting forth the following information regarding the
efforts of the reporting Party’s sales force in Detailing the Product in the
United States during the preceding [*]: (i) the total number of Details made by
such sales force in the United States, including a breakdown by First Position
Details, Second Position Details and Third Position Details by target, and
frequency of Detail by date and by individual representative; and (ii) such
other information as may be specified by the JUSLT. Each Party will provide the
other Party with a report, in such form and manner as determined by the JUSLT,
within [*] calendar days after the end of each Calendar Quarter, setting forth
the following information regarding the efforts of the reporting Party’s sales
force in Detailing the Product in the United States during the preceding
Calendar Quarter: [*]. Notwithstanding the foregoing, in the event that any
Detail(s) conducted by a Party in a given calendar [*] were not included in such
Party’s report for such [*] or Calendar Quarter, as applicable, such Party shall
[*] and the costs for such Detail(s) shall be [*]. Notwithstanding the
foregoing, the Parties may, by mutual written agreement, modify the timing,
frequency or required content of the reports contemplated by this Section 5.7.1
(Reporting).
5.7.2    Audits. Each Party will keep complete and accurate records of its
Detailing of the Product in the United States in sufficient detail to permit the
other Party to audit its performance of Details hereunder. During regular
business hours, with not less than [*] Business Days’ advance written notice and
under reasonable obligations of confidentiality which are in any event no less
stringent than those confidentiality obligations set forth in Article 10
(Confidentiality), a Party will permit an independent, internationally
recognized certified public accounting firm, selected by the other Party to:
(i) have access to the records of Detailing activities in the United States
maintained by such Party for purposes of verifying the accuracy of reports
described in Section 5.7.1 (Reporting); and (ii) audit such records; provided
that such audits may not be performed on behalf of a Party more than once per
Calendar Year, such records will be open (in such form as may be available or
reasonably requested) to inspection for at least [*] following the end of the
period to which they pertain, and such records for any particular Calendar Year
will only be subject to one (1) audit. Any and all audits undertaken pursuant to
this Section 5.7.2 (Audits) will be performed at the sole and exclusive expense
of the auditing Party and will not be included in Commercialization Costs;
provided that if an audit reveals an overstatement of Details in the United
States of greater than [*] percent ([*]%) of the correct amount for the audited
period, then the audited Party will pay the reasonable out-of-pocket cost of
such inspection.
5.8    Sales Force [*]. During the Term, if either Party intends to [*] percent
([*]%) [*] in the United States that [*] in the United States, then such Party
shall provide the other Party with at least [*] prior written notice. In such
event, at the request of either Party, the United States Senior Officers and
each Party’s Co-Chair of the JUSLT shall meet to generate a plan to [*] (with
escalation to the United States Senior Officers if the JUSLT is unable to agree
on such a plan). Such plan and any meetings or discussions related thereto shall
be kept in strict confidence by the United States

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Senior Officers and each Party’s Co-Chair of the JUSLT, in accordance with the
confidentiality obligations set forth in Article 10 (Confidentiality). The Party
that has [*] will [*] during the applicable period (but not to exceed [*]) that
are [*].
6.
MANUFACTURE AND SUPPLY

6.1    Responsibility for Manufacturing. Except as otherwise set forth in this
Section 6.1 (Responsibility for Manufacturing), Amgen will be the “Manufacturing
Lead” for the Product for the United States and shall have sole responsibility
for the supply and Manufacturing of the Product for the United States. If the
Manufacturing Lead elects to cease Manufacturing the Product for the United
States, the Manufacturing Lead shall select a Third Party commercial
manufacturer to Manufacture the Product for the United States, [*]; provided,
however, that [*].
6.2    Distribution. Amgen shall be solely responsible for distribution of the
Product in the United States.
6.3    Responsibility for Regulatory Filings with Respect to Manufacturing;
Inspections of Manufacturing Facilities. The Manufacturing Lead shall have sole
responsibility for preparing the draft of the [*] Marketing Application Core
Dossier for the United States (the “CMC Core Dossier”). As between the Parties,
the Manufacturing Lead shall have responsibility for the assessment by
Governmental Authorities of change control records of post-approval changes with
respect to the Product. Solely the Manufacturing Lead shall have the right to
participate in inspections by a Governmental Authority of any facility where the
Product is Manufactured for the United States, whether prior to or after
Regulatory Approval of the Product in the United States.
6.4    Supply [*]. If at any point during the Term after First Commercial Sale
of the Product in the United States, Amgen [*] percent ([*]%) [*] (a “Supply
[*]”), [*] a Supply [*] for purposes of this Section 6.4 (Supply [*])[*], then
Amgen shall provide Novartis written notice thereof within [*] Business Days of
the occurrence of such Supply [*]. Amgen shall also provide Novartis prompt
written notice [*] percent ([*]%) [*] (“[*]”). Amgen’s notice of [*] shall
include [*]. If a Supply [*], Novartis shall [*].
7.
DILIGENCE

7.1    Commercially Reasonable Efforts. From and after the Effective Date, the
Parties shall use Commercially Reasonable Efforts to (i) conduct Medical Affairs
Activities for the Product in the Field in the United States as contemplated by
this Agreement; and (ii) following the issuance of Regulatory Approval for the
Product in the Field in the United States, Commercialize the Product in the
Field in the United States in accordance with the Commercialization Plan;
provided that the Parties acknowledge that such Commercialization activities
shall be subject to the United States Brand Plan and in accordance with the
Global Brand Plan. In addition, Amgen shall use Commercially Reasonable Efforts
to Manufacture the Product for the United States.
7.2    Proper Conduct Practices Standards. Each Party will conduct, and ensure
that each of its Affiliates conducts, all of its and their activities with
respect to the Manufacture, Medical Affairs Activities and Commercialization of
the Product for the United States in accordance with this Agreement, accepted
national and international pharmaceutical industry codes of practices in and for
the United States, and applicable Law. The non-Regulatory Lead will provide the
Regulatory Lead with all reasonably requested cooperation to enable the
Regulatory Lead to comply with its

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legal and compliance obligations to Governmental Authorities with respect to the
Product. Notwithstanding anything to the contrary contained herein, neither
Party hereto (nor its Affiliates) shall be required to perform any obligation
hereunder to the extent that (i) such Party reasonably believes that the
performance of such obligation would be prohibited by, or would otherwise not
comply with, applicable Law or any CIA, (ii) such Party reasonably believes that
there is a Material Safety Issue with respect to the performance of such
obligation, or (iii) such Party reasonably believes it would infringe an issued
Patent of a Third Party in the applicable jurisdiction(s) for which no exemption
is available and no license has been obtained; provided, however, that the
provisions of this Section 7.2 (Proper Conduct Practices Standards) shall not
limit a Party’s payment obligations under this Agreement.
7.3    Violation of Laws. Each Party will promptly notify the other Party of any
violation of applicable Law by its personnel with respect to the conduct of
activities under this Agreement. In the event of any such violation, the Parties
will promptly confer regarding any such violation and will promptly take
remedial or preventative action as may be reasonably agreed to by the Parties
with respect thereto, subject to applicable Law relating to employment or
privacy matters. The Party employing any personnel that violates applicable Law
or applicable national or international pharmaceutical industry codes of
practices shall cause such personnel to cease to perform activities under this
Agreement.
7.4    Use of Affiliates and Third Party Contractors.
7.4.1    Each Party will perform the activities designated to it itself or
through any of its Affiliates, and any proposed use of a Third Party to conduct
such activities will be subject to the other Party’s prior written consent, such
consent not to be unreasonably withheld; provided that (i) subject to Section
7.4.2, either Party shall have the right to perform its activities hereunder
through subcontractors in the ordinary course of business consistent with the
Commercialization Plan and (ii) in the event that any Third Parties are
performing Commercialization activities with respect to the Product in the
United States on behalf of Amgen as of the Effective Date, Amgen shall have the
right to continue to perform such activities through such Third Parties. Cost
overruns resulting from either Party’s use of a Third Party to conduct any such
activities will be subject to Section 2.8 (Cost Overruns). Each Party will be
responsible for compliance by its respective Affiliates and Third Party
contractors with this Agreement and will be responsible for all acts and
omissions of such Affiliates and Third Party contractors as if committed or
omitted by the applicable Party.
7.4.2    Notwithstanding the provisions of Section 7.4.1, [*].

8.
PAYMENT

8.1    Upfront Payment. As partial consideration for the rights granted to
Novartis hereunder, Novartis shall pay Amgen a one-time [*],[*] upfront payment
of [*] within [*] days following acceptance by the FDA of the first BLA for the
Product submitted by or on behalf of Amgen.
8.2    Milestone Payments. As partial consideration for the rights granted to
Novartis hereunder:

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8.2.1    Novartis shall pay Amgen a one-time [*], [*] payment of [*] within [*]
days following the date that cumulative gross invoiced sales of the Product in
the United States (for clarity, regardless of the Calendar Year in which such
sales occur) equals or exceeds [*]; and
8.2.2    Novartis shall pay to Amgen a one-time [*], [*] payment of [*] (the
“Sales Milestone”) within [*] days following the later of (i) the date that the
aggregate of all Net Sales of the Product in the United States in a given
Calendar Year equals or exceeds [*] (the “Sales Milestone Threshold”) and
(ii) the date that [*].
8.2.3    Notwithstanding the foregoing, [*].

[*] For clarity, the Sales Milestone payments set forth under Section 8.2.2 and
8.2.3 are alternative milestones and not cumulative milestones, only one of
which, but not both, shall be paid by Novartis, meaning the total maximum Sales
Milestone payment payable under Sections 8.2.2 and 8.2.3 is [*].
8.3    Royalty Payments and Royalty Reduction for Biosimilar Competition.
8.3.1    Royalty Payments. As partial consideration for the rights granted to
Amgen hereunder, subject to Section 8.3.2 (Royalty Reduction for Biosimilar
Competition), Amgen shall pay Novartis a royalty on annual Net Sales of the
Product in the United States for each Calendar Year (or portion thereof) during
the Term at a rate of [*] percent ([*]%).
8.3.2    Royalty Reduction for Biosimilar Competition. Notwithstanding the
foregoing, if, following the date of First Commercial Sale of a Biosimilar
Product in the United States (the “US Biosimilar Entry Date”), aggregate Net
Sales of the Product in the United States in any [*] consecutive Calendar
Quarter period are less than Net Sales of the Product in the United States in
the [*] month period immediately preceding the US Biosimilar Entry Date, the
applicable royalty rate set forth in Section 8.3.1 (Royalty Payments) shall be
reduced by [*] [*] for every [*] percent ([*]%) reduction of aggregate Net Sales
of the Product in the United States in any [*] consecutive Calendar Quarter
period after the US Biosimilar Entry Date; provided the applicable royalty rate
set forth in Section 8.3.1 (Royalty Payments) shall in no event be reduced by
more than [*] in the aggregate (i.e., the royalty rate on annual Net Sales of
the Product in the United States will in no case be less than [*] percent
([*]%)). The reduced royalty rate, if any, shall apply to Net Sales of the
Product in the United States commencing on the first day of the Calendar Quarter
following the last Calendar Quarter in the [*] consecutive Calendar Quarter
period that triggers the reduction in the royalty rate. For clarity, and by way
of example only, if [*] percent ([*]%)[*].
8.4    Reports.
8.4.1    Beginning with the Calendar Quarter in which the First Commercial Sale
of the Product in the United States occurs and thereafter for each Calendar
Quarter until the expiration of the Term, reports of the sale of the Product for
each Calendar Quarter will be delivered by Amgen to Novartis under this
Agreement within [*] days after the end of each such Calendar Quarter. Such
report shall state: (i) Net Sales of the Product in the United States by or on
behalf of Amgen, its Affiliates or sublicensees during the applicable Calendar
Quarter; and (ii) a calculation of the royalty payment due from Amgen hereunder
for such Calendar Quarter. In the event of Combination Product(s), the
aforementioned report shall include a reasonably detailed calculation of how Net
Sales were calculated in relation to such Combination Product(s).

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8.4.2    Based on the reports received by Novartis from Amgen pursuant to
Section 8.4.1 and without prejudice to Section 8.9 (Audits), Novartis shall
issue an invoice to Amgen for the amount of the royalty payments indicated in
the Calendar Quarter report. Following receipt of such invoice, to the extent
that Amgen does not dispute, in good faith, the amount set forth on such
invoice, Amgen shall pay the amount of the royalty payments indicated on such
invoice within [*] days to an account designated by Novartis.
8.4.3    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.
8.5    No Wrongful Reductions. Amgen shall not attempt to reduce compensation
rightly due to Novartis hereunder by shifting compensation otherwise payable to
Amgen from a Third Party with respect to the Product to another product or
service for which no royalties are payable by it hereunder.
8.6    Cost Allocation.
8.6.1    Allocation of Recoveries, Development Costs and Program Costs. Each
Party shall account for Program Costs and Development Costs in accordance with
its Accounting Standards. Except as otherwise set forth herein:
8.6.1.1    each Party shall be entitled to share in fifty percent (50%) of
Recoveries;
8.6.1.2    each Party shall pay fifty percent (50%) of Program Costs other than
Commercialization Costs; provided that in any given Calendar Year, [*].  For
clarity, [*] (i) [*] and (ii) [*] percent ([*]%) [*] percent ([*]%)[*];
8.6.1.3    Novartis shall pay [*] percent ([*]%) of Development Costs (including
Medical Affairs Activities Costs) until such time as such Development Costs
(including Medical Affairs Activities Costs) not otherwise payable by Novartis
under the Existing License Agreement with respect to the Product equal [*] in
the aggregate, after which time each Party shall pay fifty percent (50%) of all
Development Costs (including Medical Affairs Activities Costs) in excess of
those Development Costs (including Medical Affairs Activities Costs) otherwise
payable by Novartis with respect to the Product under the Existing License
Agreement, provided that Novartis shall have no obligation to fund Development
Costs solely relating to Development of the Product for Regulatory Approval in
Japan to the extent such costs are not included in the Development Budget as of
the Effective Date. For clarity, following such payment by Novartis of such [*]
in Development Costs (including Medical Affairs Activities Costs) with respect
to the Product, Novartis will effectively pay [*] percent ([*]%) of all
Development Costs (including Medical Affairs Activities Costs) for the Product,
which includes (i) [*] percent ([*]%) of all Development Costs (including
Medical Affairs Activities Costs) (pursuant to Section 9.7.1 (Development Cost
Sharing) of the Existing License Agreement) for the Product and (ii) [*] percent
([*]%) of all Development Costs (including Medical Affairs Activities Costs) in
excess of those Development Costs otherwise payable by Novartis with respect to
the Product under the Existing License Agreement;

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8.6.1.4    for the Calendar Year 2017 only, (i) Novartis shall pay one hundred
percent (100%) of Commercialization Costs up to a cap of [*] in the aggregate,
inclusive of a [*] payment to Amgen on or prior to [*] (as a contribution toward
[*]), provided that Novartis shall have the right to prorate such payments over
the remaining Calendar Quarters in 2017, and (ii) Amgen shall be responsible for
any and all Commercialization Costs in Calendar Year 2017 above the [*] in
Commercialization Costs paid by Novartis;
8.6.1.5    for the Calendar Year 2018 only, (i) Novartis shall pay one hundred
percent (100%) of Commercialization Costs up to a cap of [*] in the aggregate,
inclusive of a [*] payment to Amgen on or prior to [*] (as a contribution toward
[*]), provided that Novartis shall have the right to prorate such payments over
the four (4) Calendar Quarters in 2018, and (ii) Amgen shall be responsible for
any and all Commercialization Costs in Calendar Year 2018 above the [*] in
Commercialization Costs paid by Novartis, and
8.6.1.6    for the Calendar Year 2019 and for each Calendar Year thereafter,
each Party shall pay fifty percent (50%) of all Commercialization Costs.
8.6.2    Payment of Costs. Subject to reconciliation as provided in Section
8.6.4 (Payments), the Party initially incurring Development Costs and Program
Costs shall be responsible for and pay for all such Development Costs and
Program Costs so incurred. Each Party shall maintain the books and records
referred to in Section 8.9 (Audits) and shall accrue all Development Costs and
Program Costs in accordance with the terms and conditions hereof and in
accordance with its Accounting Standards.
8.6.3    Reports. Without limitation of Section 5.7 (Detailing Reports and Audit
Rights), 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, if available) Program
Costs (broken down by category as set forth in the definition of Program Costs)
incurred by such Party in such Calendar Quarter, as well as any other Costs for
which such Party is entitled to reimbursement hereunder; provided that in the
event that Sales Force Costs for any Detail(s) conducted by a Party in a given
Calendar Quarter [*], such Party shall [*] such Sales Force Costs, and such
Sales Force Costs shall [*]. Such Program Costs shall be attributed by such
Party to the Calendar Quarter in which they are expensed. For clarity, the
reporting obligations of the Parties with respect to Development Costs shall be
governed by Section 9.7.3 (Reports) of the Existing License Agreement.
8.6.4    Payments. Within [*] days after the end of each Calendar Quarter, Amgen
will prepare a reconciliation report setting forth the total amounts of Program
Costs incurred by each Party in such Calendar Quarter based on the reports
submitted by the Parties pursuant to Section 8.6.3 (Reports), the allocation of
the total amounts of each category of costs within Program Costs between the
Parties in accordance with Section 8.6.1 (Allocation of Recoveries, Development
Costs and Program Costs), and the calculation of the amount payable by the
applicable Party to the other Party in order to achieve such allocation.  Based
on such reconciliation report, the Party to whom a payment is owed in order to
achieve such allocations shall issue an invoice to the other Party for the
appropriate amount in accordance with Section 8.8 (Payment Method) and the owing
Party shall make the applicable payment within [*] days after receiving such
invoice. For clarity, reconciliation payments with respect to Development Costs
shall be governed by Section 9.7.4 (Payments) of the Existing License Agreement.

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8.6.5    Calculation of Sales Force Costs. Sales Force Costs for each of the
Parties in the United States will be determined by including in
Commercialization Costs a pro rata portion of the Sales Force FTE Costs of a
Detail performed by such Party or any of its Affiliates or contractors in the
United States utilizing a First Position Detail equivalent basis as follows:
(i) [*] percent ([*]%) if such sales representative Details the Product as a
First Position Detail as set forth in the Commercialization Plan and details no
other products; (ii) [*] percent ([*]%) if such sales representative Details the
Product as the First Position Detail as set forth in the Commercialization Plan
and details only one (1) other product; (iii) [*]percent ([*]%) if such sales
representative Details the Product as a First Position Detail as set forth in
the Commercialization Plan and details only [*] ([*]) other products; (iv) [*]
percent ([*]%) if such sales representative Details the Product as a Second
Position Detail and details only [*] ([*]) or [*] ([*]) other product(s); and
(v) [*] percent ([*]%) [*] ((i) through (v), as applicable, the “First Position
Detail Equivalent Basis”).
8.7    Sublicense Payments. Each Party shall be responsible for any Third Party
license fees, milestones, royalties or other payments owed with respect to the
Product or uses or methods of Manufacture thereof (or of its components), on
intellectual property that is licensed by such Party prior to or as of the
Effective Date. For the avoidance of doubt, such sublicense payments shall not
be included in any calculation of Development Costs.
8.8    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 8.10 (Blocked Currency). Any sales
incurred in a currency other than U.S. Dollars shall be converted to the U.S.
Dollar equivalent using the applicable Party’s 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, on invoice, 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 under this Agreement shall be paid in full (subject to Section
8.12 (Withholding) and Section 8.13 (VAT)).
8.9    Audits. Each Party shall keep complete and accurate records showing (i)
the expenses incurred by it in performing its activities under the
Commercialization Plan, (ii) its Program Costs, (iii) Net Sales of the Product
in the United States and the calculation of royalty payments due and (iv)
calculation of the License Payments, during the three (3) preceding Calendar
Years, which books and records shall be in sufficient detail to confirm the
accuracy of all payments due hereunder. Such records of each Party 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 8.9
(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, with not less than ten (10) Business Days’
advance written notice and under reasonable obligations of confidentiality which
are in any event no less stringent than those confidentiality obligations set
forth in Article 10 (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

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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. For clarity, the audit rights of the
Parties with respect to Development Costs shall be governed by Section 9.11
(Audits) of the Existing License Agreement.
8.10    Blocked Currency. If at any time legal restrictions prevent the prompt
remittance of any payments with respect to sales therein, the Party making
payment shall have the right and option to make such payments by depositing the
amount thereof in local currency to the other Party’s account in a bank or
depository designated by such other Party.
8.11    Taxes. All Taxes levied on account of a payment pursuant to this
Agreement will be subject to the withholding and remittance provisions of
Section 8.12 (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.
8.12    Withholding. In the event that Law requires either Party to pay or
withhold Taxes with respect to any payment to be made by such Party pursuant to
this Agreement, such Party shall notify the other Party in writing of such
payment or withholding requirements prior to making the payment and provide such
assistance to the other Party, including the provision of such documentation as
may be required by a tax authority, as may be reasonably necessary to claim an
exemption from or reduction of such Taxes. The Party making payment will, in
accordance with Law, withhold Taxes from the amount due, remit such Taxes to the
appropriate tax authority, and furnish the other Party 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, each Party shall
provide such assistance to the other Party 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
a Party unilaterally restructures the payment of any monies payable to the other
Party under this Agreement such that such first Party or any of its Affiliates
makes the payment of such monies payable to the other Party under this Agreement
and solely as a result of such unilateral restructuring said amount is subject
to withholding and further, such other Party is not able to recover or credit
all or part of such withheld amount(s), such first Party agrees to compensate
the other Party without interest 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 such other Party. For the avoidance of
doubt, the preceding sentence shall apply only in respect of a unilateral
restructuring of payments by such first Party and shall not apply (x) in the
event of a change in applicable Law or circumstance, (y) as the result of such
other Party’s inability to recover or credit such withholding on a current or
future basis due to such other

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Party’s taxable income (loss) position or other tax attributes in a given year,
or (z) for any other reason beyond the exclusive control of such first Party.
8.13    VAT. All payments due pursuant to this Agreement shall be paid exclusive
of any VAT (which, if applicable, shall be payable upon receipt of a valid VAT
invoice).
8.14    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 8.14 (Late
Payment) shall in no way limit any other remedies available to either Party.
8.15    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
Commercialization expertise, clinical data and other financial and non-financial
consideration and that the royalty payments set forth in Section 8.3 (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 royalty payments set forth in this Article 8 (Payment) are
reasonable.
9.
INTELLECTUAL PROPERTY

9.1    Ownership and Cooperation.
9.1.1    Ownership of Technology. 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 US Collaboration and, subject to the provisions of this
Agreement and the Existing License Agreement, 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 US 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). Notwithstanding the foregoing, any Copyrights pertaining to
Promotional Materials, Non-Promotional Materials or training materials for the
Product in the United States shall be owned solely by the Commercial Lead.
9.1.2    Notification. Each Party shall promptly notify the other upon becoming
aware (i) of any actual, suspected or threatened material infringement of any
Amgen Technology, Novartis Technology, Amgen Product Trademarks, Novartis
Product Trademarks or Joint Patents; (ii) of any claim that either Party’s
exercise of the rights granted under any Amgen Technology, Novartis Technology,
Amgen Product Trademarks, Novartis Product Trademarks or Joint Patents 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 Product; (iv) of any threatened,
suspected or actual material misappropriation of Amgen Know-How or Novartis
Know-How; and/or (v) of any actual, suspected or threatened material
infringement

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or dilution of the Amgen Product Trademarks, Novartis Product Trademarks, Amgen
Housemarks as used with the Product or Novartis Housemarks as used with the
Product, all of the foregoing, (i) through (v), anywhere in the world.
9.2    Prosecution and Maintenance.
9.2.1    Amgen Primary Prosecution. Amgen shall control, itself or through
outside counsel reasonably acceptable to Novartis and directed by Amgen, Patent
and Trademark Matters with respect to Amgen Patents, Amgen Product Trademarks
and Joint Patents (in the case of Joint Patents, the prosecution will be in the
name of both Parties), in each case solely in the United States (collectively,
the “United States Patents and Trademarks”), as well as preparation and filing
for any patent term extensions or similar protections therefor. From and after
the Effective Date, with respect to United States Patents and Trademarks
specific to the Product, (i) Amgen shall provide Novartis with copies of and an
opportunity to review and comment upon the text of the applications relating to
such United States 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 such United States Patents and Trademarks reasonably promptly
after making such filing or receiving such document, including a copy of each
application for each item within such United States 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 such United States
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’ comments on the
communications, filings and submissions for such United States Patents and
Trademarks.
9.2.2    Novartis Secondary Prosecution. From and after the Effective Date, with
respect to United States Patents and Trademarks specific to the Product, if
Amgen proposes to abandon or fail to maintain any patent, trademark or
application within such United States 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, control Patent and Trademark Matters with respect to such patent,
trademark or application within such United States Patents and Trademarks
thereafter in accordance with this Section 9.2.2 (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 United States,
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 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.

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9.2.3    Novartis Primary Prosecution. Novartis shall control, itself or through
outside counsel reasonably acceptable to Amgen and directed by Novartis, Patent
and Trademark Matters with respect to Novartis Patents and Novartis Product
Trademarks, in each case solely in the United States (collectively, the “United
States Novartis Patents and Trademarks”), as well as preparation and filing for
any patent term extensions or similar protections therefor. From and after the
Effective Date, with respect to United States Novartis Patents and Trademarks
specific to the Product, (i) Novartis shall provide Amgen with copies of and an
opportunity to review and comment upon the text of the applications relating to
such United States Novartis 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) Novartis shall provide Amgen with a copy of each submission made to
and document received from a patent or trademark authority, court or other
tribunal regarding any such United States Novartis Patents and Trademarks
reasonably promptly after making such filing or receiving such document,
including a copy of each application for each item within such United States
Novartis Patents and Trademarks as filed together with notice of its filing date
and application number, (iii) Novartis shall keep Amgen advised of the status of
all material communications, actual and prospective filings or submissions
regarding such United States Novartis Patents and Trademarks, and shall give
Amgen 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) Novartis shall reasonably
consider in good faith Amgen’s comments on the communications, filings and
submissions for such United States Novartis Patents and Trademarks.
9.2.4    Amgen Secondary Prosecution. From and after the Effective Date, with
respect to United States Novartis Patents and Trademarks specific to the
Product, if Novartis proposes to abandon or fail to maintain any patent,
trademark or application within such United States Novartis Patents and
Trademarks, it shall give Amgen reasonable notice thereof (with sufficient time
for Amgen to assume control thereof and continue the prosecution or maintenance
of such patent, trademark or application) and thereafter Amgen may, upon written
notice to Novartis, control Patent and Trademark Matters with respect to such
patent, trademark or application within such United States Novartis Patents and
Trademarks thereafter in accordance with this Section 9.2.4 (Amgen Secondary
Prosecution) (any patent, trademark or application so assumed, an “Amgen Assumed
Item”). Amgen shall control, itself or through outside counsel reasonably
acceptable to the Parties and directed by Amgen, Patent and Trademark Matters
with respect to Amgen Assumed Items in the United States, as well as preparation
and filing for any patent term extensions or similar protections therefor. Amgen
shall provide Novartis with a copy of each material submission made to and
document received from a patent or trademark authority regarding any Amgen
Assumed Items reasonably promptly after making such filing or receiving such
document, including a copy of each application for each item within the Amgen
Assumed Items as filed together with notice of its filing date and application
number.
9.2.5    Amgen Territory. Except to the extent expressly provided otherwise in
the Existing License Agreement, in the Amgen Territory, Amgen shall control and
be solely responsible for all Patent and Trademark Matters with respect to (i)
its patent rights, trademark rights and other intellectual property and (ii)
Joint Patents. Notwithstanding the other provisions of this Section 9.2.5 (Amgen
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

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would reasonably be expected to [*] the Amgen Patents, the Novartis Patents or
the conduct of Medical Affairs Activities with respect to or Commercialization
of the Product [*].
9.2.6    Expenses. Costs incurred in connection with Patent and Trademark
Matters in accordance with this Section 9.2 (Prosecution and Maintenance) in the
United States will be included as Other Costs.
9.3    Defense and Settlement of Third Party Claims.
9.3.1    United States Patents and Trademarks. From and after the Effective
Date, if a Third Party asserts that a patent right or other right owned by it is
infringed by the Manufacture, use, sale, offer for sale or importation of the
Product by either Party in the United States, such Party shall have the sole
right to defend against any such assertions. The other Party shall reasonably
assist such first Party and cooperate in any such litigation at such first
Party’s request. Subject to such control, the other Party may join any defense
and settlement pursuant to this Section 9.3 (Defense and Settlement of Third
Party Claims). The Party defending the Third Party claim shall seek and
reasonably consider the other Party’s comments before determining the strategy
for such matter. Without limiting the foregoing, each Party shall keep the other
advised of all material communications and actual and prospective filings or
submissions regarding such action, and shall provide the other Party with
(i) copies of and an opportunity to review and comment on any such
communications, filings and submissions and (ii) Calendar Quarterly updates on
estimated and actual Costs incurred in connection therewith. Neither Party shall
settle or consent to the entry of any judgment in any such action without the
other Party’s prior written consent, not to be unreasonably withheld or delayed,
unless such settlement (a) includes a complete release from liability with
respect to the Third Party claim and (b) does not include any admission of
wrongdoing by such other Party. Each Party shall keep the other fully informed
of all claims and actions governed by this Section 9.3 (Defense and Settlement
of Third Party Claims). In the event either Party becomes engaged in:
(1) settlement discussions with a Third Party that has specifically asserted
that a patent right or Trademark of such Third Party would be infringed by the
Manufacture, use, sale, offer for sale or importation of the Product in the
United States; (2) settlement discussions of an interference involving a patent
right or Trademark of such Party corresponding to a Patent or Trademark that is
subject to the licenses granted hereunder; or (3) cross-license discussions with
respect to a patent right or Trademark corresponding to a Patent or Trademark
that is subject to the licenses granted hereunder: (A) such Party shall keep the
other reasonably informed of the status of such discussions; and (B) such Party
shall consider in good faith any comments or suggestions of the other Party.
Costs incurred in connection with such defense and settlement of Third Party
claims in accordance with this Section 9.3.1 (United States Patents and
Trademarks) (including under Section 9.5 (Cooperation)) will be included as
Other Costs (other than Costs incurred by a Party in fulfilling its
indemnification obligations hereunder). In the event that a Third Party asserts
that a patent right or other right owned by it is infringed by the sale, offer
for sale or importation of the Product by both Parties in the United States, the
Parties shall discuss and develop a joint strategy with respect to the defense
against any such assertions. For clarity, notwithstanding the foregoing or
anything to the contrary contained herein, Amgen shall have no obligation to
share with Novartis any Product manufacturing or CMC information or any
information related to products other than the Product.

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9.3.2    Amgen Territory Patents and Trademarks.  From and after the Effective
Date, with respect to Amgen Patents, Amgen Product Trademarks and Joint Patents,
in each case in the Amgen Territory (collectively, the “Amgen Territory Patents
and Trademarks”) specific to the Product, 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 Product in the Amgen Territory by Amgen,
except to the extent expressly provided otherwise in the Existing License
Agreement, 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 (including legal fees) incurred in
connection therewith. Subject to such control, Novartis may join any defense and
settlement pursuant to this Section 9.3 (Defense and Settlement of Third Party
Claims), with its own counsel at its sole cost. Amgen shall seek and reasonably
consider Novartis’ 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 Amgen Patents, the Amgen Product Trademarks or
the conduct of Medical Affairs Activities with respect to or Commercialization
of the Product in [*].
9.3.3    Mutual Provisions. Each Party shall have the right to redact any
information disclosed to the other Party pursuant to this Section 9.3 (Defense
and Settlement of Third Party Claims) relating to any product other than the
Product.
9.4    Infringement Notice; Enforcement.
9.4.1    Notice. Each Party shall promptly notify the other Party in writing if
it reasonably believes that any United States Patents and Trademarks or United
States Novartis Patents and Trademarks are infringed or misappropriated by a
Third Party in the United States.
9.4.2    Amgen Primary Enforcement. From and after the Effective Date, with
respect to United States Patents and Trademarks specific to the Product, Amgen
shall have the first right, but not the obligation, to enforce such United
States Patents and Trademarks against any actual, alleged or threatened
infringement or misappropriation by Third Parties in the United States, subject
to Section 9.5 (Cooperation). In the event Amgen elects to bring and prosecute
such an action, Novartis shall reasonably assist Amgen and cooperate in any such
action at Amgen’s request, and Amgen shall seek and reasonably consider
Novartis’ comments before determining the strategy. 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
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 Product from any such materials).
9.4.3    Novartis Secondary Enforcement. From and after the Effective Date, with
respect to United States Patents and Trademarks specific to the Product, in the
event Amgen does not commence an enforcement action or otherwise take action to
abate any alleged infringement or misappropriation of any such United States
Patents and Trademarks within [*] days after Novartis

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requests Amgen 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)),
Novartis shall be entitled to bring and prosecute such an action and Amgen will
cooperate with Novartis. If Novartis elects to bring and prosecute such an
action, then Novartis shall seek and reasonably consider Amgen’s comments on
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
(provided that Novartis shall have the right to redact any information relating
to any product other than the Product from any such materials). Novartis shall
not settle, or consent to any judgment in, any action under this Section 9.4.3
(Novartis Secondary Enforcement) [*].
9.4.4    Novartis Primary Enforcement. From and after the Effective Date, with
respect to United States Novartis Patents and Trademarks specific to the
Product, Novartis shall have the first right, but not the obligation, to enforce
such United States Novartis Patents and Trademarks against any actual, alleged
or threatened infringement or misappropriation by Third Parties in the United
States, 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’ request, 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.
9.4.5    Amgen Secondary Enforcement. From and after the Effective Date, with
respect to United States Novartis Patents and Trademarks specific to the
Product, in the event Novartis does not commence an enforcement action or
otherwise take action to abate any alleged infringement or misappropriation of
any such United States Novartis 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 and
Novartis will cooperate with Amgen. If Amgen elects to bring and prosecute such
an action, then Amgen shall seek and reasonably consider Novartis’ comments on
strategy. 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 material communications, filings and
submissions (provided that Amgen shall have the right to redact any information
relating to any product other than the Product from any such materials). Amgen
shall not settle, or consent to any judgment in, any action under this Section
9.4.5 (Amgen Secondary Enforcement), without Novartis’ prior written consent,
not to be unreasonably withheld or delayed.
9.4.6    Enforcement Costs. Costs incurred in connection with enforcement
activities pursuant to this Section 9.4 (Infringement Notice; Enforcement)
(including under Section 9.5 (Cooperation) but excluding Section 9.4.7 (Amgen
Territory) and 9.4.8 (Novartis Intellectual Property Rights Outside the United
States)) shall be included as Other Costs.

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9.4.7    Amgen Territory. Except to the extent expressly provided otherwise in
the Existing License Agreement, 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 in the Amgen Territory against
any actual, alleged or threatened infringement or misappropriation by Third
Parties in the Amgen Territory, and to settle any such matters in its sole
discretion subject to Section 9.3 (Defense and Settlement of Third Party
Claims). Except to the extent expressly provided otherwise in the Existing
License Agreement, Novartis shall have no right to enforce such rights in the
Amgen Territory.
9.4.8    Novartis Intellectual Property Rights Outside the United States.
Novartis shall have the sole right, but not the obligation, to enforce Novartis
Patents and Novartis Product Trademarks outside the United States against any
actual, alleged or threatened infringement or misappropriation by Third Parties
outside the United States, and to settle any such matters in its sole
discretion. Amgen shall have no right to enforce such rights outside the United
States.
9.5    Cooperation. When either Party is bringing or defending an action of the
type described in Section 9.3 (Defense and Settlement of Third Party Claims) or
Section 9.4 (Infringement Notice; Enforcement), then upon reasonable request by
such a Party, the other Party will reasonably assist in the defense against or
enforcement of such action, 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.
9.6    Patent Term Extensions. From and after the Effective Date, with respect
to United States Patents and Trademarks and United States Novartis Patents and
Trademarks, in each case specific to the Product, each Party shall provide
reasonable assistance to the other Party in connection with obtaining SPCs for
such Amgen Patents, Novartis Patents and Joint Patents consistent with the
rights of the other Party to control such matters as specified in Section 9.2
(Prosecution and Maintenance). To the extent reasonably and legally required in
order to obtain any such SPC in the United States, 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 the United
States.
9.7    Employee Agreements. Prior to beginning work relating to any aspect of
the subject matter of this Agreement or being given access to Amgen Technology
or Novartis Technology or the 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:
(i) promptly reporting any Information, as appropriate; (ii) 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; (iii) cooperating in the preparation, filing,
prosecution, maintenance, enforcement and defense of any intellectual property
rights; (iv) 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 (v) 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

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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.
10.
CONFIDENTIALITY

10.1    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 except as
required under the Commercialization Plan or as expressly permitted under the
Existing License Agreement. 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:
10.1.1    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;
10.1.2    was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving Party;
10.1.3    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;
10.1.4    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
10.1.5    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.
10.2    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,
Manufacture, Commercialization or Medical Affairs Activities under this
Agreement; (ii) to the extent such disclosure is to a Governmental

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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 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 manufacturing technology related Confidential Information is
not shared with any of its or its Affiliates’ personnel (whether employees,
consultants, Third Party contractors or otherwise and whether or not located
within the United States): (i) [*] and (ii) [*].
10.3    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 Product or, in
the case of Amgen, subject to the Existing License Agreement, Franchise Product
2 and Franchise Product 3.
10.4    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 the 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, at a date(s) and time(s) to be mutually
agreed by the Parties, 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. This Agreement supersedes the Confidential
Disclosure Agreement between Amgen and Novartis or its Affiliates dated [*]
including any written requests thereunder, (the “Prior Agreement”) with respect
to information disclosed thereunder relating to the Product and the research and
Development related thereto. All confidential information exchanged between the
Parties under the Prior Agreement shall

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be deemed Confidential Information of the disclosing Party and shall be subject
to the terms of this Agreement.
10.5    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.
11.
REPRESENTATIONS, WARRANTIES AND COVENANTS

11.1    Mutual Representations and Warranties. Each of the Parties hereby
represents and warrants to the other Party as follows:
11.1.1    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;
11.1.2    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;
11.1.3    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 FDA 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;
11.1.4    As of the Effective Date, it has not been debarred or excluded or the
subject of debarment or exclusion proceedings by any Governmental Authority;
11.1.5    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 Novartis, the activities identified in the Settlement Agreement entered
into between Novartis and the Office of the Inspector General of the United
States Health and Human Services in the United States Department of Justice in
September 2010 and the Settlement Agreement entered into between Novartis and
the Office of

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the Inspector General of the United States Health and Human Services in the
United States Department of Justice in November 2015 and, 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 United
States Health and Human Services in the United States Department of Justice in
December 2012; and
11.1.6    As of the Effective Date, it has not knowingly used in connection with
the 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.
11.2    Novartis Representations and Warranties. Novartis hereby represents
that, as of the Effective Date:
11.2.1    Novartis has the right to grant the rights granted to Amgen under this
Agreement, and no rights granted to Amgen pursuant to this Agreement are in
violation of any agreement between Novartis or any of its Affiliates and any
Third Party;
11.2.2    As of the Effective Date, it has sufficient legal and/or beneficial
title and ownership under the Novartis Technology, Novartis Product Trademarks
(if any) and Novartis Housemarks to grant the licenses to the other Party as
purported to be granted pursuant to this Agreement; and
11.2.3    Novartis is part of the Novartis AG group of companies (“Novartis
Group”), Novartis AG owns, directly or indirectly, all of the shares and
ownership interests in Novartis, and Novartis [*].
11.3    Amgen Representations and Warranties. Amgen hereby represents that, as
of the Effective Date:
11.3.1    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;
11.3.2    Amgen has sufficient legal and/or beneficial title and ownership under
the Amgen Technology, Amgen Product Trademarks and Amgen Housemarks to grant the
licenses to the other Party as purported to be granted pursuant to this
Agreement;
11.3.3    Amgen Controls the Amgen Patents listed on the Amgen Patents Schedule,
free of any Liens. The Amgen Patents in the United States listed on the Amgen
Patents Schedule constitute a true and complete list of all Patents Controlled
by Amgen in the United States specific to the Product in the United States.
11.3.4    Amgen has not received any written notice from any Third Party
asserting or alleging that the Manufacture, use or sale of the Product in or for
the United States infringes rights of such Third Party;
11.3.5    Amgen has not received any written notice of any opposition or
challenge against any Amgen Patent in the United States;
11.3.6    All data and information relating to the Product filed by Amgen with
the FDA are true and accurate in all material respects;

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11.3.7    Amgen has filed with the FDA all [*] relating to the Product in
Amgen’s possession that are required to be filed, and has made available to
Novartis, all such [*]; and
11.3.8    Amgen has not received any written notice that any Governmental
Authority has commenced any investigation or any action to withdraw any
Regulatory Filing with respect to the Manufacture, conduct of Medical Affairs
Activities with respect to or Commercialization of the Product in the United
States, [*].
11.4    Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 11
(REPRESENTATIONS, WARRANTIES AND COVENANTS) OR ARTICLE 12 (REPRESENTATIONS,
WARRANTIES AND COVENANTS) OF THE EXISTING LICENSE AGREEMENT, NOVARTIS AND AMGEN
EXPRESSLY DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE, WITH RESPECT TO THE US COLLABORATION, THE PRODUCT, THE
AMGEN TECHNOLOGY, AMGEN PRODUCT TRADEMARKS, AMGEN HOUSEMARKS, NOVARTIS
TECHNOLOGY, NOVARTIS PRODUCT TRADEMARKS, NOVARTIS HOUSEMARKS, 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 11
(Representations, Warranties and Covenants) or Article 12 (Representations,
Warranties and Covenants) of the Existing License Agreement, all licenses by
Novartis to Amgen under the Novartis Technology, Novartis Product Trademarks and
Novartis Housemarks shall be granted “as-is” and all licenses by Amgen to
Novartis under the Amgen Technology, Amgen Product Trademarks and Amgen
Housemarks shall be granted “as-is”.
11.5    Mutual Covenants. Each of the Parties hereby covenants to the other
Party as follows:
11.5.1    It shall not knowingly use in connection with the 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;
11.5.2    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 conduct of Medical Affairs
Activities, Manufacture or Commercialization to take place pursuant to this
Agreement:
11.5.2.1    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.
11.5.2.2    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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11.5.2.3    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 11.5.2.1 and 11.5.2.2
above.
11.5.2.4    Each Party shall promptly provide the other Party with written
notice of the following events:
(i)    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 11.5.2.1 and 11.5.2.2.
(ii)    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.
11.5.3    If either Party requests that the other Party complete a compliance
certification certifying compliance with Section 11.5.2.1, 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;
11.5.4    If either Party requests, in connection with a CIA, 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, and should there be reasonable additional requests of
such other Party as a result of a CIA of the requesting Party, such other Party
shall comply with such requests;
11.5.5    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 including the Prescription Drug Marketing Act of
1987 (PDMA), the Federal Drug and Cosmetic Act, the Medicare/Medicaid
anti-kickback statute, and the Health Insurance Portability and Accountability
Act (HIPAA)) 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) or similar applicable code and the PhRMA Code on
Interactions with Healthcare Professionals, the Accreditation Council for
Continuing Medical Education (ACCME) requirements for continuing medical
education, and the American Medical Association (AMA) Ethical Guidelines on
Gifts to Physicians from Industry, as the same may be amended from time to time,
and each Party shall promptly notify the other Party of and provide the other
Party with a copy of any correspondence or other reports with respect to the
Detailing and Commercialization of the Product submitted to or received from the
PhRMA, the ACCME or the AMA relating to the foregoing;

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11.5.6    If sampling is directed or approved by the JUSLT, each Party shall
conform its practices and procedures relating to Product sampling in the United
States to sampling practices and procedures it follows with respect to its other
similar prescription products, which practices and procedures shall be in
compliance with the Prescription Drug Marketing Act of 1987 (PDMA), as may be
amended from time to time, and each Party shall promptly provide the other Party
with any correspondence or other reports submitted to or received from the FDA
related to Product sampling;
11.5.7    Each Party shall not grant any right to any Third Party that conflicts
with the rights granted to the other Party hereunder; and
11.5.8    [*]
11.6    Novartis Covenant. Novartis shall [*].
12.
LIMITATIONS OF LIABILITY; INSURANCE

12.1    Limitations of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO
THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR
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 12.1 (Limitations of Liability) shall not
apply with respect to (i) either Party’s indemnification obligations under
Article 13 (Indemnification); (ii) Section 10.1 (Confidentiality; Exceptions) or
Section 10.2 (Authorized Disclosure); (iii) Section 12.2 (Insurance) or (iv) the
gross negligence or willful misconduct of a Party.
12.2    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.
13.
INDEMNIFICATION

13.1    Sharing of Liability Expenses. Except where caused by the gross
negligence or willful misconduct of a Party seeking reimbursement, the Parties
shall share equally (50%/50%) all losses, damages, liabilities, settlements,
penalties, fines and Costs (including, without limitation, reasonable attorneys’
fees and expenses) (“Shared Liability Losses”) arising out of or caused by the
conduct of Medical Affairs with respect to or Manufacture or Commercialization
of the Product under this Agreement, including product liability claims and
Costs associated with any Recalls and returns of the Product in the Field in the
United States, other than to the extent the responsibility for any such loss,
damage, liability, settlement, penalty, fine or Cost (“Liability”) is covered by
the indemnification provisions of Sections 13.2 (Indemnification by Novartis) or
13.3 (Indemnification by Amgen) and except in the case that Amgen reasonably
requests Novartis or its Affiliates or licensees to take prompt mitigating
actions (including conducting a Recall) with respect to Product

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delivered that failed to be Manufactured in compliance with cGMP or to meet the
applicable specifications at time of delivery, in which case (i) Amgen shall be
responsible for the Costs related to such mitigating actions and (ii) Novartis
shall be responsible for Liabilities with respect to Product for which Novartis
or its Affiliates or licensees declines to take such requested actions.
13.2    Indemnification by Novartis. Subject to the remainder of this Article 13
(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’ cost and expense, from and against any and all
liabilities, losses, costs, damages, fees or expenses (collectively, “Losses”)
(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) 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; or (ii) a breach by Novartis of
this Agreement, including any failure of Novartis’ representations or warranties
in Section 11.1 (Mutual Representations and Warranties) or Section 11.2
(Novartis Representations and Warranties) to be true; in each case excluding
such Losses to the extent they arise from the gross negligence or willful
misconduct of Amgen or any Amgen Indemnified Party, or by the breach of this
Agreement by Amgen.
13.3    Indemnification by Amgen. Subject to the remainder of this Article 13
(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 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 (i) the gross negligence or willful
misconduct of Amgen, its Affiliates or agents in performing under this
Agreement; (ii) a breach by Amgen of this Agreement, including any failure of
Amgen’s representations or warranties in Section 11.1 (Mutual Representations
and Warranties) or Section 11.3 (Amgen Representations and Warranties) to be
true; or (iii) the death or injury of a person caused by the failure of Product
manufactured by Amgen, its Affiliates or its licensees (other than Novartis, its
Affiliates or its licensees) to be Manufactured in compliance with cGMP or to
meet the applicable specification at time of delivery; in each case excluding
such Losses to the extent they arise from the gross negligence or willful
misconduct of Novartis or any Novartis Indemnified Party, or by the breach of
this Agreement by Novartis.
13.4    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 13 (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 13.4 (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

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set forth below in this Section, 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 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 10
(Confidentiality). 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.
14.
TERM AND TERMINATION

14.1    Term. This Agreement shall come into effect as of the Effective Date
and, unless otherwise terminated pursuant to the provisions of Article 14 (Term
and Termination), shall remain in effect during the Term.
14.2    Termination. This Agreement may be terminated as follows:
14.2.1    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 (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

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with Section 15.3 (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.
14.2.2    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.
14.2.3    Termination for Challenge. Amgen shall have the right to terminate
this Agreement should Novartis, its Affiliate or its or their licensee under the
Amgen Patents or Amgen Product Trademarks bring or join any challenge to the
validity or enforceability of any Amgen Patent or Amgen Product 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.
14.2.4    Termination for Convenience. Novartis shall have the right to
terminate this Agreement from and after [*] following the fifth anniversary of
Regulatory Approval of the Product in the United States upon [*] prior written
notice to Amgen. For clarity, Novartis may provide written notice of termination
to Amgen at any time from or after [*] following [*], such that this Agreement
may be terminated by Novartis effective any time from or after [*] following the
fifth anniversary of Regulatory Approval of the Product in the United States.
14.2.5    Termination for [*]. Novartis shall have the right to [*] terminate
this Agreement upon written notice to Amgen [*].
14.2.6    Termination for [*]. Novartis shall have the right to [*] terminate
this Agreement upon written notice to Amgen [*].
14.2.7    Termination for [*]. Amgen shall have the right to terminate this
Agreement upon [*] days’ prior written notice to Novartis pursuant to [*] of the
[*].

14.3    Effect of Termination. Termination of this Agreement shall have the
following effects with regard to the Product:
14.3.1    General. In the event of any termination of this Agreement, unless
otherwise expressly provided, any liabilities previously accrued (including the
obligation of Amgen to pay royalties pursuant to Section 8.3 (Royalty Payments
and Royalty Reduction for Biosimilar Competition)) with respect to sales of the
Product made prior to the effective date of such termination 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).
14.3.2    Termination Effects. In the event of any termination of this
Agreement, (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 Product in the United States 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,

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Medical Affairs Activities and any other activities as requested by Amgen with
respect to the Product in the United States to Amgen in accordance with Section
14.5 (Transition Period); (iii) the Parties shall cooperate to promptly
transition sole responsibility for the prosecution, maintenance and enforcement
in the United States of United States Patents and Trademarks and United States
Novartis Patents and Trademarks specific to the Product to Amgen; (iv) all
sublicenses granted by Novartis shall terminate; (v) Amgen shall have the right
to control all Recalls of the Product in the United States, and in each case
Novartis shall provide any reasonable assistance requested by Amgen in
connection therewith; (vi) Section 3.2 (Novartis Technology) (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 the Product as of the date of termination) shall survive
[*]; (vii) Amgen shall have a fully-paid, royalty-free [*] right and license to
use the Novartis Product Trademarks (if any) (and the associated goodwill) in
connection with the Product in all indications within the United States; and
(viii) the Parties shall cooperate to promptly transfer ownership of all Domain
Names and Domain Name registrations (including in each case with respect to
nonproprietary names for the Product) related to the Product held by Novartis to
Amgen, save as to any Domain Names and Domain Name registrations that contain
any Novartis Housemarks; provided that [*] shall bear any expenses incurred in
connection with any such transfer except that, in the event of termination by
Amgen pursuant to Section [*] or by Novartis pursuant to Section [*] shall bear
such expenses.
14.3.3    Additional Termination Effects. In addition to the effects of
termination set forth in Section 14.3.2 (Termination Effects), the following
will apply:
14.3.3.1    in the event of termination of this Agreement by Novartis pursuant
to Section [*], Amgen shall pay to Novartis, commencing on the effective date of
termination (the “Termination Date”) and continuing [*], a royalty on annual Net
Sales of the Product in the United States for each Calendar Year (or portion
thereof) at the following rates: (a) [*]percent ([*]%) if the Termination Date
occurs [*], (b) [*]percent ([*]%) if the Termination Date occurs [*], (c) [*]
percent ([*]%) if the Termination Date occurs [*] and (d) [*]percent ([*]%) if
the Termination Date occurs on or after [*].
14.3.3.2    in the event of termination of this Agreement by Novartis pursuant
to Section [*], commencing on the Termination Date and continuing until [*],
Amgen shall pay to Novartis a royalty on annual Net Sales of the Product in the
United States for each Calendar Year (or portion thereof) at the following
rates: (i) [*]percent ([*]%) if the Termination Date occurs [*], (ii) [*]
percent ([*]%) if the Termination Date occurs [*] and (iii) [*]percent ([*]%) if
the Termination Date occurs [*].
14.3.3.3    in the event of any termination of this Agreement, other than a
termination by Novartis pursuant to Section [*],[*].
14.4    Additional Surviving Provisions. In addition and without prejudice to
the provisions of Section 14.3 (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: Article 1 (Definitions)
(to the extent defined terms are contained in the following surviving Articles
and Sections), Article 10 (Confidentiality); Articles 12 (Limitations of
Liability; Insurance); 13 (Indemnification); 14 (Term and Termination) and 15
(Miscellaneous); Section 5.7 (Detailing Reports and Audit Rights) (with respect
to Details made prior to such termination), Sections 8.1

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(Upfront Payment) and 8.2.1 [*]; Sections 8.3 (Royalty Payments and Royalty
Reduction for Biosimilar Competition) through 8.5 (No Wrongful Reductions)
(inclusive) (with respect to sales made prior to such termination); Section 8.6
(Cost Allocation) (with respect to Program Costs and Development Costs
reasonably incurred prior to such termination and for Recoveries with respect to
periods prior to termination); Sections 8.8 (Payment Method) through 8.14
(Appropriate Measure of Value); 9.1.1 (Ownership of Technology); and 11.4
(Disclaimer of Warranties).
14.5    Transition Period. Without limitation of Section 14.3 (Effect of
Termination), in the event of any termination of this Agreement by Amgen
pursuant to Section [*] or by Novartis 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 Medical Affairs Activities with respect to and Commercialization
of the Product in the Field in the United States to Amgen with respect to such
activities. 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 Medical
Affairs Activities with respect to and Commercialization of the Product in the
United States. Subject to Section 14.3.2 (Termination Effects), the Parties
shall each be responsible for their own costs incurred in accordance with this
Section.
15.
MISCELLANEOUS

15.1    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.
15.2    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, in the case of Amgen, Amgen, and in the case of Novartis, [*]. 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.
15.3    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

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to plead or claim 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.
15.4    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.
15.5    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.
15.6    Entire Agreement. This Agreement, including the attached Appendices,
Schedules and Exhibits and the Safety Agreement and together with the Existing
License Agreement, 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.
15.7    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 use its commercially reasonable efforts to avoid or remove
such causes of non-performance and to mitigate the effect of

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such occurrence, and shall continue performance with reasonable dispatch
whenever such causes are removed.
15.8    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.
15.9    Headings. Headings and captions are for convenience only and are not to
be used in the interpretation of this Agreement.
15.10    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).
15.11    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: [*]
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 should be sent at any time upon written notice
delivered to the other Party in accordance with this Section 15.11 (Notices).
15.12    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

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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.
15.13    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.
15.14    Third Party Beneficiaries. Except as expressly provided with respect to
Amgen Indemnitees or Novartis Indemnities in Article 13 (Indemnification), there
are no third party beneficiaries intended hereunder and no Third Party shall
have any right or obligation hereunder.
15.15    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)

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

NOVARTIS PHARMA AG
 
AMGEN INC.
By: /Nigel Sheail/
 
 
By:
/Robert A. Bradway/
Name: Nigel Sheail
 
 
Name:
Robert A. Bradway
Title: Novartis Pharma AG Head Business Development & Licensing
Forum 2-6.04
4002 Basel
 
 
Title:
Chairman of the Board, President & Chief Executive Officer
 
 
 
 
 
 
NOVARTIS PHARMA AG
 
 
 
By: /Natalie Tan/
 
 
 
 
Name: Natalie Tan
 
 
 
 
Title: Head Legal Respiratory Franchise
 
 

        

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Schedule
Amgen Patents

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

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Press Release

(see attached)

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amgenlogoa06.jpg [amgenlogoa06.jpg]

Press Release

Amgen Announces Expanded Commercial Collaboration With Novartis For Erenumab In
Migraine

Collaboration Designed to Maximize the Launch of First-in-Class Program and to
More Effectively Reach People Living With Migraine
THOUSAND OAKS, Calif., April 24, 2017 /PRNewswire/ -  Amgen (NASDAQ:AMGN) today
announced an expanded commercial collaboration with Novartis for erenumab, which
is being investigated for the prevention of migraine. This expanded commercial
collaboration builds on a global neuroscience collaboration in Alzheimer's
disease and migraine established in 2015 between Novartis and Amgen. This
expanded collaboration leverages Novartis' strong and established presence in
neuroscience to more effectively reach people with migraine. The companies have
agreed to combine capabilities to co-commercialize erenumab in the
U.S. Amgen retains exclusive commercialization rights in Japan. Novartis gains
exclusive rights to commercialize erenumab in Canada, and retains its existing
commercialization rights in rest of the world. The companies will continue
global co-development.
Erenumab is a fully human monoclonal antibody specifically designed to target
and block the Calcitonin Gene-Related Peptide (CGRP) receptor, believed to have
a critical role in mediating the incapacitating pain of migraine. Positive data
from a Phase 2 study and positive top-line results for two Phase 3 studies in
migraine prevention were announced in 2016. Detailed results from the Phase 3
studies will be presented at the annual meeting of the American Academy of
Neurology and submitted for publication. These data will help support
discussions with regulatory agencies, with filing anticipated in the second
quarter of 2017.
Under the terms of the agreement, Amgen will receive milestone payments
from Novartis expected to begin in 2017. Novartis will share U.S.
commercialization costs with Amgen. Amgen will book sales of erenumab in the
U.S., and will pay a royalty to Novartis on net sales in the U.S. Novartis will
book sales in the rest of the world, excluding Japan, and will
pay Amgen royalties on the net sales in those countries. Amgen will book sales
in Japan, since it will remain an exclusive territory for the
Company. Novartis will assume agreed upon remaining global development costs up
to a cap and share global development costs thereafter.

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"Migraine is a debilitating disease and today many patients are sub-optimally
treated due to tolerability issues with existing therapies," said Anthony C.
Hooper, executive vice president of Global Commercial Operations at Amgen.
"Combining the U.S. capabilities of Amgen and Novartis in preparation for the
launch of erenumab can create meaningful value over the life of this
first-in-class program by enabling us to more effectively, and perhaps even more
rapidly, reach people who live with the impact of migraine on a daily basis."
This is an expansion of a global collaboration with Novartis announced
in September 2015 in neuroscience, involving joint development and
commercialization of pioneering treatments in the field of Alzheimer's disease
and migraine.

About Erenumab
Erenumab is a fully human monoclonal antibody specifically designed for the
prevention of migraine. Erenumab targets and blocks the Calcitonin Gene-Related
Peptide (CGRP) receptor, thought to be pivotal in the genesis of migraine.
Erenumab has been studied in several large global, randomized, double-blind,
placebo-controlled studies to assess its safety and efficacy in migraine
prevention. Positive results from a Phase 2 study and positive top-line data
from two Phase 3 studies in migraine prevention were announced in 2016. These
data will help support discussions with regulatory agencies, with filings
anticipated in 2017.
About Migraine
Migraine is a distinct neurological disease.1 People with migraine lose a
substantial portion of their lives to this illness, experiencing significant
physical impairment, frequently accompanied by head pain, nausea, vomiting and
meaningful disruption of daily activities.1 The World Health Organization ranks
migraine as one of the most debilitating illnesses.2 For the approximately 10
million Americans whose migraine frequency or severity impacts daily activities,
preventive medications may be an option.3 Approximately 3.5 million of these
patients are currently on a preventive therapy, but up to 80 percent discontinue
these within one year because of intolerable side effects or limited
efficacy.4 Migraine is associated with personal and societal burdens of pain,
disability, and financial cost, and it remains under-recognized and
under-treated.
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 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. All statements, other than statements
of historical fact, are statements that could be deemed forward-looking
statements, including estimates of

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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 reports filed by Amgen, including our most recent annual report on
Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date of this news
release and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. 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 us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar variability in
the future. Even when clinical trials are successful, regulatory authorities may
question the sufficiency for approval of the trial endpoints we have selected.
We develop 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 we may have believed at the time of entering into
such relationship. Also, we or others could identify safety, side effects or
manufacturing problems with our products after they are on the market.
Our results may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and regulatory
developments involving current and future products, sales growth of recently
launched products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global economic
conditions. In addition, sales of our products are affected by pricing pressure,
political and public scrutiny and 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. Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. We or others could identify safety, side
effects or manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be impacted by the
adoption of new tax legislation or exposure to additional tax liabilities. If we
fail to meet the compliance obligations in the corporate integrity agreement
between us and the U.S. government, we could become subject to significant
sanctions. Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors, or we may fail to
prevail in present and future intellectual property litigation. We perform a
substantial amount of our commercial manufacturing activities at a few key
facilities and also depend on third

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parties for a portion of our manufacturing activities, and limits on supply may
constrain sales of certain of our current products and product candidate
development. In addition, we compete with other companies with respect to many
of our marketed products as well as for the discovery and development of new
products. Further, some raw materials, medical devices and component parts for
our products are supplied by sole third-party suppliers. Certain of our
distributors, customers and payers have substantial purchasing leverage in their
dealings with us. The discovery of significant problems with a product similar
to one of our products that implicate an entire class of products could have a
material adverse effect on sales of the affected products and on our business
and results of operations. Our efforts to acquire other companies or products
and to integrate the operations of companies we have acquired may not be
successful. We may not be able to access the capital and credit markets on terms
that are favorable to us, or at all. We are increasingly dependent on
information technology systems, infrastructure and data security. Our stock
price is volatile and may be affected by a number of events. Our business
performance could affect or limit the ability of our Board of Directors to
declare a dividend or our ability to pay a dividend or repurchase our common
stock.
The scientific information discussed in this news release relating to new
indications for our products is preliminary and investigative and is not part of
the labeling approved by the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s) discussed in this
news release, and no conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (Media)
Kristen Neese, 805-313-8267 (Media)
Arvind Sood, 805-447-1060 (Investors)
References
1. Migraine Research Foundation. Migraine Fact Sheet. 2015.
Available: http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed April 7, 2017.
2. World Health Organization. Headache Disorder Fact Sheet.
Available: http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed April
7, 2017.
3. Lipton RB, et al. Migraine prevalence, disease burden, and the need for
preventative therapy. Neurology. 2007; 68(5):343-9.
4. Marketscan data on file.  3-24-2017. Ref Type: Data File

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

MEDIA RELEASE • COMMUNIQUE AUX MEDIAS • MEDIENMITTEILUNG
Novartis expands global collaboration with Amgen to
commercialize first-in-class AMG 334 (erenumab) program in
migraine prevention in the U.S. and Canada

•
Novartis and Amgen to co-commercialize AMG 334 (erenumab) in the US; Novartis to
gain exclusive rights in Canada

•
Novartis retains commercial rights in rest of world; Amgen retains commercial
rights in Japan

•
Companies to combine capabilities and leverage Novartis strong and established
neuroscience presence in the US and across the globe to maximize launch of AMG
334 (erenumab)

Basel, April 24, 2017 - Novartis today announced an expanded commercialization
agreement with Amgen for AMG 334 (erenumab), which is being investigated for the
prevention of migraine. This agreement builds on a 2015 global collaboration
between Novartis and Amgen, and leverages almost 70 years of Novartis experience
in neuroscience to more effectively reach people with migraine. Novartis and
Amgen will co-commercialize AMG 334 (erenumab) in the US. Novartis will retain
exclusive rights to commercialize the drug in rest of world and will gain
commercialization rights in Canada. Amgen retains exclusive commercialization
rights in Japan. The companies will continue global co-development.
AMG 334 (erenumab) is a fully human monoclonal antibody specifically designed
for the prevention of migraine. It targets and blocks the Calcitonin
Gene-Related Peptide (CGRP) receptor, believed to play a critical role in
mediating the incapacitating pain of migraine.[1] Positive results from a Phase
II study and two Phase III studies of AMG 334 (erenumab) in migraine prevention
were announced in 2016. In these studies, once-monthly subcutaneous AMG 334
(erenumab) significantly reduced monthly migraine days versus placebo and
demonstrated a safety profile comparable to placebo.[2],[3],[4] Detailed results
from the Phase

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III studies are being presented at the annual meeting of the American Academy of
Neurology and submitted for publication. These data will help support
discussions with regulatory agencies, with filing anticipated in the second
quarter of 2017.
"Migraine is a debilitating neurological disease associated with significant
personal, economic, and societal burden. There is an urgent need for effective
and well-tolerated preventive treatments that positively impact the lives of
people with migraine," said Paul Hudson, Chief Executive Officer, Novartis
Pharmaceuticals. "We are excited to expand our collaboration with Amgen. We look
forward to combining capabilities and leveraging our strong heritage in
neuroscience in the US and Canada to bring erenumab to more patients in need, as
fast as we can."
Under the terms of the agreement, Amgen will receive milestone payments from
Novartis, expected to begin in 2017. Novartis will share US commercialization
costs with Amgen. Amgen will book sales of AMG 334 (erenumab) in the US, and
will pay a royalty to Novartis on net sales in the US. Novartis will book sales
in rest of the world, excluding Japan, and will pay Amgen royalties on the net
sales in those countries. Amgen will book sales in Japan, since it will remain
an exclusive territory for the company. Novartis will assume agreed upon
remaining global development costs up to a cap and share global development
costs thereafter.
The agreement is an expansion of a global collaboration with Amgen announced in
August 2015 in neuroscience, involving joint development and commercialization
of pioneering treatments in the field of Alzheimer's disease and migraine.[5]
About AMG 334 (erenumab)
AMG 334 (erenumab) is a fully human monoclonal antibody specifically designed to
target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, believed
to play a critical role in mediating the incapacitating pain of migraine.[1] AMG
334 (erenumab) has been studied in several large global, randomized,
double-blind, placebo-controlled trials to assess its safety and efficacy in
migraine prevention. Following the initial Phase II dose finding study, the
efficacy of AMG 334 (erenumab) in migraine prevention has been shown in a Phase
II trial and two Phase III trials. The safety profile of AMG 334 (erenumab) in
these studies was comparable to placebo.[2],[3],[4]

About Migraine
Migraine is a distinct neurological disease.[6] It involves recurrent attacks of
moderate to severe head pain that is typically pulsating, often unilateral and
associated with nausea, vomiting and sensitivity to light, sound and odors.[7]

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Migraine is associated with personal pain, disability and reduced quality of
life, and financial cost to society.[8] It has a profound and limiting impact on
an individual's abilities to carry out everyday tasks, and was declared by the
World Health Organization to be one of the top 10 causes of years lived with
disability for men and women.[9] It remains under-recognized and
under-treated.[8],[10] Existing preventive therapies have been repurposed from
other indications and are often associated with poor tolerability and lack of
efficacy, which lead to increasing discontinuation rates and dissatisfaction
among patients.[11]

About the Amgen and Novartis Neuroscience Collaboration
In August 2015, Novartis entered into a global collaboration with Amgen to
jointly develop and commercialize pioneering neuroscience treatments in the
field of Alzheimer's disease (AD) and migraine. The companies are partnering in
the development and commercialization of a beta-secretase 1 (BACE) inhibitor
program in AD. Novartis' oral therapy CNP520 (currently in a Phase II/III study
for AD) will be the lead molecule and further compounds from both companies'
pre-clinical BACE inhibitor programs may be considered as novel follow-on
molecules. The 2015 collaboration also focuses on innovative investigational
Amgen drugs in the migraine field, including AMG 334 (erenumab) in migraine
prevention and AMG 301 (currently in a Phase I study for migraine).

Novartis in Neuroscience
Novartis has a strong ongoing commitment to neuroscience and to bringing
innovative treatments to patients suffering from neurological conditions where
there is a high unmet need. We are committed to supporting patients and
physicians in multiple disease areas, including Multiple Sclerosis (MS),
Alzheimer's disease (AD), Parkinson's disease, Epilepsy and Attention Deficit
Hyperactivity Disorder, and have a promising pipeline in MS, AD, migraine and
specialty neurology (e.g. neuropathic pain).

Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "to co-commercialize," "to gain," "to combine," "launch,"
"being investigated," "builds on," "will," "believed to," "submitted,"
"anticipated," "excited," "look forward," "expected," "pioneering," "may,"
"investigational," "ongoing," "commitment," "pipeline," or similar terms, or by
express or implied discussions regarding potential marketing approvals for AMG
334, CNP520, AMG 301, other BACE inhibitors of Novartis and Amgen, and other
investigational compounds of Novartis and Amgen subject to the collaboration,
potential new indications or labeling for products in the Novartis Neuroscience
portfolio, or regarding potential future revenues from such investigational

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compounds and products, and potential future revenues from the 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 AMG 334, CNP520, AMG 301, other BACE
inhibitors of Novartis and Amgen, or other investigational compounds of Novartis
and Amgen subject to the collaboration will be submitted or approved for sale in
any market, or at any particular time. Neither can there be any guarantee that
the 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
any product in the Novartis Neuroscience portfolio 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 AMG 334, CNP520, AMG 301, any of
the other investigational compounds subject to the collaboration with Amgen, or
any product in the Novartis Neuroscience portfolio will be commercially
successful in the future. In particular, management's expectations regarding
such investigational compounds and products, and the collaboration with Amgen,
could be affected by, among other things, the uncertainties inherent in research
and development, including clinical trial results and additional analysis of
existing clinical data; 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 and reimbursement
pressures; safety, quality or manufacturing 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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-

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time-equivalent associates. Novartis products are sold in approximately 155
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)
For Novartis multimedia content, please
visit www.novartis.com/news/media-library
For questions about the site or required registration, please
contact media.relations@novartis.com
References
1. Bigal ME et al. Calcitonin Gene-Related Peptide (CGRP) and Migraine Current
Understanding and State of Development. Headache. 2013;53(8):1230-1244.
2. Novartis presents new positive data at EHMTIC showing AMG 334 significantly
reduces monthly migraine days in chronic
migraine. https://www.novartis.com/news/media-releases/novartis-presents-new-positive-data-ehmtic-showing-amg-334-significantly-reduces.
Accessed April 2017.
3. Novartis announces Phase III study shows AMG 334 significantly reduces
monthly migraine data in people with episodic
migraine. https://www.novartis.com/news/media-releases/novartis-announces-phase-iii-study-shows-amg-334-significantly-reduces-monthly.
Accessed April 2017.
4. Novartis announces AMG 334 significantly reduces monthly migraine days in
second pivotal Phase III episodic migraine
study. https://www.novartis.com/news/media-releases/novartis-announces-amg-334-significantly-reduces-monthly-migraine-days-second.
Accessed April 2017.
5. Novartis announces global partnership with Amgen to develop and commercialize
pioneering neuroscience
treatments. https://www.novartis.com/news/media-releases/novartis-announces-global-p....
Accessed April 2017. 
6. Migraine Research Foundation. Migraine Fact Sheet.
2015. http://www.migraineresearchfoundation.org/fact-sheet.html(link is
external). Accessed April 2017.
7. National Institute for Neurological Disorders and
Stroke. https://www.ninds.nih.gov/Disorders/All-Disorders/Migraine-Information-Page(link
is external) (link is external). Accessed April 2017.
8. World Health Organization. Headache
disorders. http://www.who.int/mediacentre/factsheets/fs277/en/(link is
external) (link is external). Accessed October 2016.
9. World Health Organization. Estimates for 2000-2012. Disease Burden. 2012.
10. Diamond S et al. Patterns of Diagnosis and Acute and Preventive Treatment

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for Migraine in the United States: Results from the American Migraine Prevalence
and Prevention Study. Headache. 2007;47(3):355-63.
11. Hepp Z, et al. Adherence to oral migraine-preventive medications among
patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

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
+ 41 61 324 8631 (direct)
+ 41 79 752 6955 (mobile)
angela.fiorin@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central North America                        North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448    Richard Pulik +1 212
830 2448
Pierre-Michel Bringer +41 61 324 1065
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188

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Schedule
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